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Sample records for multicentre manikin study

  1. Pediatric Basic Life Support Self-training is Comparable to Instructor-led Training: A randomized manikin study

    DEFF Research Database (Denmark)

    Vestergaard, L. D.; Løfgren, Bo; Jessen, C.

    2011-01-01

    Pediatric Basic Life Support Self-training is comparable to Instructor-led Training: A randomized manikin study.......Pediatric Basic Life Support Self-training is comparable to Instructor-led Training: A randomized manikin study....

  2. Manikin families representing obese airline passengers in the US.

    Science.gov (United States)

    Park, Hanjun; Park, Woojin; Kim, Yongkang

    2014-01-01

    Aircraft passenger spaces designed without proper anthropometric analyses can create serious problems for obese passengers, including: possible denial of boarding, excessive body pressures and contact stresses, postural fixity and related health hazards, and increased risks of emergency evacuation failure. In order to help address the obese passenger's accommodation issues, this study developed male and female manikin families that represent obese US airline passengers. Anthropometric data of obese individuals obtained from the CAESAR anthropometric database were analyzed through PCA-based factor analyses. For each gender, a 99% enclosure cuboid was constructed, and a small set of manikins was defined on the basis of each enclosure cuboid. Digital human models (articulated human figures) representing the manikins were created using a human CAD software program. The manikin families were utilized to develop design recommendations for selected aircraft seat dimensions. The manikin families presented in this study would greatly facilitate anthropometrically accommodating large airline passengers.

  3. The Force-Displacement Relationship in Commonly Used Resuscitation Manikins: Not Very Human

    DEFF Research Database (Denmark)

    Thomsen, Jakob E; Stærk, Mathilde; Løfgren, Bo

    2017-01-01

    Introduction: Manikins are widely used for CPR training and designed to simulate a human in cardiac arrest. Previous studies show a non-linear force-displacement relationship in the human chest. This may not be the case for resuscitation manikins. The aim of this study was to investigate the force......-displacement relationship in commonly used resuscitation manikins.Methods: Commonly used infant and adult manikins for resuscitation training were included in the study. Manikins were tested by placing them in a material testing machine (ProLine Z050, Zwick/Roell, Ulm, Germany). A piston was placed on lower half...... (Laerdal) and CPR Anytime® Infant (inflatable; American Heart Association) and five adult manikins: Mini Anne (inflatable), Little Anne®, Resusci Anne, Resusci Anne Advanced(Laerdal) and Ambu® Man (Ambu). Infant manikins required a force of 57 N and 34 N to compress the chest 3 cm. The force required...

  4. Deformation of a sound field caused by a manikin

    DEFF Research Database (Denmark)

    Weinrich, Søren G.

    1981-01-01

    around the head at distances of 1 cm to 2 m, measured from the tip of the nose. The signals were pure tones at 1, 2, 4, 6, 8, and 10 kHz. It was found that the presence of the manikin caused changes in the SPL of the sound field of at most ±2.5 dB at a distance of 1 m from the surface of the manikin....... Only over an interval of approximately 20 ° behind the manikin (i.e., opposite the sound source) did the manikin cause much larger changes, up to 9 dB. These changes are caused by destructive interference between sounds coming from opposite sides of the manikin. In front of the manikin, the changes...

  5. The thermal insulation difference of clothing ensembles on the dry and perspiration manikins

    International Nuclear Information System (INIS)

    Xiaohong, Zhou; Chunqin, Zheng; Yingming, Qiang; Holmér, Ingvar; Gao, Chuansi; Kuklane, Kalev

    2010-01-01

    There are about a hundred manikin users around the world. Some of them use the manikin such as 'Walter' and 'Tore' to evaluate the comfort of clothing ensembles according to their thermal insulation and moisture resistance. A 'Walter' manikin is made of water and waterproof breathable fabric 'skin', which simulates the characteristics of human perspiration. So evaporation, condensation or sorption and desorption are always accompanied by heat transfer. A 'Tore' manikin only has dry heat exchange by conduction, radiation and convection from the manikin through clothing ensembles to environments. It is an ideal apparatus to measure the thermal insulation of the clothing ensemble and allows evaluation of thermal comfort. This paper compares thermal insulation measured with dry 'Tore' and sweating 'Walter' manikins. Clothing ensembles consisted of permeable and impermeable clothes. The results showed that the clothes covering the 'Walter' manikin absorbed the moisture evaporated from the manikin. When the moisture transferred through the permeable clothing ensembles, heat of condensation could be neglected. But it was observed that heavy condensation occurred if impermeable clothes were tested on the 'Walter' manikin. This resulted in a thermal insulation difference of clothing ensembles on the dry and perspiration manikins. The thermal insulation obtained from the 'Walter' manikin has to be modified when heavy condensation occurs. The modified equation is obtained in this study

  6. Performance study of protective clothing against hot water splashes: from bench scale test to instrumented manikin test.

    Science.gov (United States)

    Lu, Yehu; Song, Guowen; Wang, Faming

    2015-03-01

    Hot liquid hazards existing in work environments are shown to be a considerable risk for industrial workers. In this study, the predicted protection from fabric was assessed by a modified hot liquid splash tester. In these tests, conditions with and without an air spacer were applied. The protective performance of a garment exposed to hot water spray was investigated by a spray manikin evaluation system. Three-dimensional body scanning technique was used to characterize the air gap size between the protective clothing and the manikin skin. The relationship between bench scale test and manikin test was discussed and the regression model was established to predict the overall percentage of skin burn while wearing protective clothing. The results demonstrated strong correlations between bench scale test and manikin test. Based on these studies, the overall performance of protective clothing against hot water spray can be estimated on the basis of the results of the bench scale hot water splashes test and the information of air gap size entrapped in clothing. The findings provide effective guides for the design and material selection while developing high performance protective clothing. Published by Oxford University Press on behalf of the British Occupational Hygiene Society 2014.

  7. Simulating Physiological Response with a Passive Sensor Manikin and an Adaptive Thermal Manikin to Predict Thermal Sensation and Comfort

    Energy Technology Data Exchange (ETDEWEB)

    Rugh, John P [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Chaney, Larry [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Hepokoski, Mark [ThermoAnalytics Inc.; Curran, Allen [ThermoAnalytics Inc.; Burke, Richard [Measurement Technology NW; Maranville, Clay [Ford Motor Company

    2015-04-14

    Reliable assessment of occupant thermal comfort can be difficult to obtain within automotive environments, especially under transient and asymmetric heating and cooling scenarios. Evaluation of HVAC system performance in terms of comfort commonly requires human subject testing, which may involve multiple repetitions, as well as multiple test subjects. Instrumentation (typically comprised of an array of temperature sensors) is usually only sparsely applied across the human body, significantly reducing the spatial resolution of available test data. Further, since comfort is highly subjective in nature, a single test protocol can yield a wide variation in results which can only be overcome by increasing the number of test replications and subjects. In light of these difficulties, various types of manikins are finding use in automotive testing scenarios. These manikins can act as human surrogates from which local skin and core temperatures can be obtained, which are necessary for accurately predicting local and whole body thermal sensation and comfort using a physiology-based comfort model (e.g., the Berkeley Comfort Model). This paper evaluates two different types of manikins, i) an adaptive sweating thermal manikin, which is coupled with a human thermoregulation model, running in real-time, to obtain realistic skin temperatures; and, ii) a passive sensor manikin, which is used to measure boundary conditions as they would act on a human, from which skin and core temperatures can be predicted using a thermophysiological model. The simulated physiological responses and comfort obtained from both of these manikin-model coupling schemes are compared to those of a human subject within a vehicle cabin compartment transient heat-up scenario.

  8. Plastic with personality: Increasing student engagement with manikins.

    Science.gov (United States)

    Power, Tamara; Virdun, Claudia; White, Haidee; Hayes, Carolyn; Parker, Nicola; Kelly, Michelle; Disler, Rebecca; Cottle, Amanda

    2016-03-01

    Simulation allows students to practice key psychomotor skills and gain technical proficiency, fostering the development of clinical reasoning and student confidence in a low risk environment. Manikins are a valuable learning tool; yet there is a distinct lack of empirical research investigating how to enhance engagement between nursing students and manikins. To describe student perspectives of a layered, technology enhanced approach to improve the simulation learning experience. Tanner's Model of Clinical Judgment underpins the entire curriculum. This study additionally drew on the principles of narrative pedagogy. Across ten teaching weeks, five separate case studies were introduced to students through short vignettes. Students viewed the vignettes prior to their laboratory class. In the labs, manikins were dressed in the props used in the vignettes. The innovation was trialed in a second year core subject of a Bachelor of Nursing program in a large urban university in the autumn semester of 2014. Following ethics approval, students were emailed a participant information sheet. A focus group of nine students was held. The discussion was digitally recorded and transcribed verbatim prior to being subject to thematic analysis. Students' comments (143) about the vignettes in their standard subject specific student feedback surveys were also considered as data. Four themes were identified: Getting past the plastic; knowing what to say; connecting and caring; and, embracing diversity. The feedback indicated that these measures increased students ability to suspend disbelief, feel connected to, and approach the manikins in a more understanding and empathetic fashion. In addition to achieving increased engagement with manikins, other advantages such as students reflecting on their own values and pre-conceived notions of people from diverse backgrounds were realized. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. The Inflatable Mini Anne® Manikin May be Used as an Inexpensive Alternative to a Standard Life-size Resuscitation Manikin During Instructor-led BLS/AED Training - A Randomized Controlled Study

    DEFF Research Database (Denmark)

    Bang, Camilla; Cordsen, Anna-Sophie N; Hoe, Masja B

    2017-01-01

    -led BLS/AED training. All participants underwent an end-of-course test on an AMBU® Man-manikin (AMBU). The primary endpoint: performing all steps of the European Resuscitation Council BLS/AED algorithm correctly (passing the test). Secondary endpoints: CPR quality parameters and manikin preference...

  10. Comparison of the quality of chest compressions on a dressed versus an undressed manikin: A controlled, randomised, cross-over simulation study

    Directory of Open Access Journals (Sweden)

    Brindley Peter G

    2010-03-01

    Full Text Available Abstract Background Undressing the chest of a cardiac arrest victim may delay the initiation of chest compressions. Furthermore, expecting laypeople to undress the chest may increase bystander reluctance to perform cardiopulmonary resuscitation (CPR. Both of these factors might conceivably decrease survival following cardiac arrest. Therefore, the aim of this study was to examine if the presence or absence of clothes affected the quality of chest compressions during CPR on a simulator manikin. Methods Thirty laypeople and 18 firefighters were randomised to start CPR on the thorax of a manikin that was either clothed (three layers or not. Data were obtained via recordings from the manikin and audio- and video-recordings. Measurements were: maximum compression depth; compression rate; percentage of compressions with correct hand positioning; percentage of compressions with complete release (≤ 10 mm, and percentage of compressions of the correct depth (range 40-50 mm. Laypeople were given a four-hour European Resuscitation Council standardised course in basic life support and tested immediately after. Firefighters were tested without additional training. Mock cardiac arrest scenarios consisted of three minutes of CPR separated by 15 minutes of rest. Results No significant differences were found between CPR performed on an undressed manikin compared to a dressed manikin, for laypeople or firefighters. However, undressing the manikin was associated with a mean delay in the initiation of chest compressions by laypeople of 23 seconds (N = 15, 95% CI: 19;27. Conclusions In this simulator manikin study, there was no benefit gained in terms of how well CPR was performed by undressing the thorax. Furthermore, undressing the thorax delayed initiation of CPR by laypeople, which might be clinically detrimental for survival.

  11. A new suction mask to reduce leak during neonatal resuscitation: a manikin study.

    Science.gov (United States)

    Lorenz, Laila; Maxfield, Dominic A; Dawson, Jennifer A; Kamlin, C Omar F; McGrory, Lorraine; Thio, Marta; Donath, Susan M; Davis, Peter G

    2016-09-01

    Leak around the face mask is a common problem during neonatal resuscitation. A newly designed face mask using a suction system to enhance contact between the mask and the infant's face might reduce leak and improve neonatal resuscitation. The aim of the study is to determine whether leak is reduced using the suction mask (Resusi-sure mask) compared with a conventional mask (Laerdal Silicone mask) in a manikin model. Sixty participants from different professional categories (neonatal consultants, fellows, registrars, nurses, midwives and students) used each face mask in a random order to deliver 2 min of positive pressure ventilation to a manikin. Delivered airway pressures were measured using a pressure line. Inspiratory and expiratory flows were measured using a flow sensor, and expiratory tidal volumes and mask leaks were derived from these values. A median (IQR) leak of 12.1 (0.6-39.0)% was found with the conventional mask compared with 0.7 (0.2-4.6)% using the suction mask (p=0.002). 50% of the participants preferred to use the suction mask and 38% preferred to use the conventional mask. There was no correlation between leak and operator experience. A new neonatal face mask based on the suction system reduced leak in a manikin model. Clinical studies to test the safety and effectiveness of this mask are needed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  12. A virtual reality dental simulator predicts performance in an operative dentistry manikin course.

    Science.gov (United States)

    Imber, S; Shapira, G; Gordon, M; Judes, H; Metzger, Z

    2003-11-01

    This study was designed to test the ability of a virtual reality dental simulator to predict the performance of students in a traditional operative dentistry manikin course. Twenty-six dental students were pre-tested on the simulator, prior to the course. They were briefly instructed and asked to prepare 12 class I cavities which were automatically graded by the simulator. The instructors in the manikin course that followed were unaware of the students' performances in the simulator pre-test. The scores achieved by each student in the last six simulator cavities were compared to their final comprehensive grades in the manikin course. Class standing of the students in the simulator pre-test positively correlated with their achievements in the manikin course with a correlation coefficient of 0.49 (P = 0.012). Eighty-nine percent of the students in the lower third of the class in the pre-test remained in the low performing half of the class in the manikin course. These results indicate that testing students in a dental simulator, prior to a manikin course, may be an efficient way to allow early identification of those who are likely to perform poorly. This in turn could enable early allocation of personal tutors to these students in order to improve their chances of success.

  13. Comparison of fabric skins for the simulation of sweating on thermal manikins

    Science.gov (United States)

    Koelblen, Barbara; Psikuta, Agnes; Bogdan, Anna; Annaheim, Simon; Rossi, René M.

    2017-09-01

    Sweating is an important thermoregulatory process helping to dissipate heat and, thus, to prevent overheating of the human body. Simulations of human thermo-physiological responses in hot conditions or during exercising are helpful for assessing heat stress; however, realistic sweating simulation and evaporative cooling is needed. To this end, thermal manikins dressed with a tight fabric skin can be used, and the properties of this skin should help human-like sweat evaporation simulation. Four fabrics, i.e., cotton with elastane, polyester, polyamide with elastane, and a skin provided by a manikin manufacturer (Thermetrics) were compared in this study. The moisture management properties of the fabrics have been investigated in basic tests with regard to all phases of sweating relevant for simulating human thermo-physiological responses, namely, onset of sweating, fully developed sweating, and drying. The suitability of the fabrics for standard tests, such as clothing evaporative resistance measurements, was evaluated based on tests corresponding to the middle phase of sweating. Simulations with a head manikin coupled to a thermo-physiological model were performed to evaluate the overall performance of the skins. The results of the study showed that three out of four evaluated fabrics have adequate moisture management properties with regard to the simulation of sweating, which was confirmed in the coupled simulation with the head manikin. The presented tests are helpful for comparing the efficiency of different fabrics to simulate sweat-induced evaporative cooling on thermal manikins.

  14. Measurement and prediction of indoor air quality using a breathing thermal manikin.

    Science.gov (United States)

    Melikov, A; Kaczmarczyk, J

    2007-02-01

    The analyses performed in this paper reveal that a breathing thermal manikin with realistic simulation of respiration including breathing cycle, pulmonary ventilation rate, frequency and breathing mode, gas concentration, humidity and temperature of exhaled air and human body shape and surface temperature is sensitive enough to perform reliable measurement of characteristics of air as inhaled by occupants. The temperature, humidity, and pollution concentration in the inhaled air can be measured accurately with a thermal manikin without breathing simulation if they are measured at the upper lip at a distance of measured inhaled air parameters. Proper simulation of breathing, especially of exhalation, is needed for studying the transport of exhaled air between occupants. A method for predicting air acceptability based on inhaled air parameters and known exposure-response relationships established in experiments with human subjects is suggested. Recommendations for optimal simulation of human breathing by means of a breathing thermal manikin when studying pollution concentration, temperature and humidity of the inhaled air as well as the transport of exhaled air (which may carry infectious agents) between occupants are outlined. In order to compare results obtained with breathing thermal manikins, their nose and mouth geometry should be standardized.

  15. Manikin Testing on LASA Suit

    National Research Council Canada - National Science Library

    Durnford, W; Potter, P

    2006-01-01

    As part of a BL2 with the Directorate of Aerospace Engineering Support DAES, DRDC Toronto required testing to be conducted on a thermal immersion manikin to evaluate the thermal resistance of the NBC...

  16. Pengembangan Pintu Air Irigasi Pintar Berbasis Arduino untuk Daerah Irigasi Manikin

    OpenAIRE

    Laumal, Folkes Eduward; Hattu, Edwin P; Nope, Kusa B. N

    2017-01-01

    In general, irrigation watergates placed in the Manikin Irrigation Area is supporting tools for agricultural activities that implement a primary–secondary–tertiary channel system. Manikin irrigation watergate is made of iron plates with the certain size which is operated by a move up/down or rotation. This mechanism has led the dissatisfaction service problems in farmers. This study has developed smart irrigation watergate based on Arduino by replacing the lifter/rotator part using DC motor t...

  17. Pengembangan Pintu Air Irigasi Pintar berbasis Arduino untuk Daerah Irigasi Manikin

    OpenAIRE

    Folkes Eduward Laumal; Edwin P. Hattu; Kusa B. N. Nope

    2017-01-01

    In general, irrigation watergates placed in the Manikin Irrigation Area is supporting tools for agricultural activities that implement a primary–secondary–tertiary channel system. Manikin irrigation watergate is made of iron plates with the certain size which is operated by a move up/down or rotation. This mechanism has led the dissatisfaction service problems in farmers. This study has developed smart irrigation watergate based on Arduino by replacing the lifter/rotator part using DC motor t...

  18. A Comparative Introduction on Sweating Thermal Manikin “Newton” and “Walter”

    OpenAIRE

    Wang, Faming

    2008-01-01

    Recently, thermal manikins are frequently used for testing and product development by sports science and human excises field, by the building industry and by the automobile industry for evaluation of the performance of heating and ventilation systems. Multisegments thermal manikin “Newton” and onesegment thermal manikin “Walter” was described in the paper. The thermal insulation and moisture vapor resistance was briefly introduced. The advantages and disadvantages of thos...

  19. Airflow characteristics and pollution distribution around a thermal manikin - Impact of specific personal and indoor environmental factors

    DEFF Research Database (Denmark)

    Licina, Dusan; Tham, Kwok Wai; Melikov, Arsen Krikor

    2016-01-01

    , and ventilation flow considerably affected airflow characteristics and pollution distribution around the thermal manikin. Under the specific set of conditions studied, the most favorable airflow patterns in preventing the feet pollution from reaching the breathing zone was transverse flow from the front......This study presents a summary of experimental measurements on the airflow characteristics and pollution distribution around a non-breathing thermal manikin. The two objectives are: (1) to examine the extent to which personal (body posture, clothing insulation, table positioning) and environmental...... factors (room air temperature and ventilation flow) affect the airflow characteristic (velocity and temperature) around the thermal manikin and (2) to examine the pollution distribution within the convective boundary layer (CBL) around a thermal manikin and personal exposure to two types of airborne...

  20. A thermal manikin with human thermoregulatory control: implementation and validation.

    Science.gov (United States)

    Foda, Ehab; Sirén, Kai

    2012-09-01

    Tens of different sorts of thermal manikins are employed worldwide, mainly in the evaluation of clothing thermal insulation and thermal environments. They are regulated thermally using simplified control modes. This paper reports on the implementation and validation of a new thermoregulatory control mode for thermal manikins. The new control mode is based on a multi-segmental Pierce (MSP) model. In this study, the MSP control mode was implemented, using the LabVIEW platform, onto the control system of the thermal manikin 'Therminator'. The MSP mode was then used to estimate the segmental equivalent temperature (t(eq)) along with constant surface temperature (CST) mode under two asymmetric thermal conditions. Furthermore, subjective tests under the same two conditions were carried out using 17 human subjects. The estimated segmental t(eq) from the experiments with the two modes and from the subjective assessment were compared in order to validate the use of the MSP mode for the estimation of t(eq). The results showed that the t(eq) values estimated by the MSP mode were closer to the subjective mean votes under the two test conditions for most body segments and compared favourably with values estimated by the CST mode.

  1. Poor chest compression quality with mechanical compressions in simulated cardiopulmonary resuscitation: a randomized, cross-over manikin study.

    Science.gov (United States)

    Blomberg, Hans; Gedeborg, Rolf; Berglund, Lars; Karlsten, Rolf; Johansson, Jakob

    2011-10-01

    Mechanical chest compression devices are being implemented as an aid in cardiopulmonary resuscitation (CPR), despite lack of evidence of improved outcome. This manikin study evaluates the CPR-performance of ambulance crews, who had a mechanical chest compression device implemented in their routine clinical practice 8 months previously. The objectives were to evaluate time to first defibrillation, no-flow time, and estimate the quality of compressions. The performance of 21 ambulance crews (ambulance nurse and emergency medical technician) with the authorization to perform advanced life support was studied in an experimental, randomized cross-over study in a manikin setup. Each crew performed two identical CPR scenarios, with and without the aid of the mechanical compression device LUCAS. A computerized manikin was used for data sampling. There were no substantial differences in time to first defibrillation or no-flow time until first defibrillation. However, the fraction of adequate compressions in relation to total compressions was remarkably low in LUCAS-CPR (58%) compared to manual CPR (88%) (95% confidence interval for the difference: 13-50%). Only 12 out of the 21 ambulance crews (57%) applied the mandatory stabilization strap on the LUCAS device. The use of a mechanical compression aid was not associated with substantial differences in time to first defibrillation or no-flow time in the early phase of CPR. However, constant but poor chest compressions due to failure in recognizing and correcting a malposition of the device may counteract a potential benefit of mechanical chest compressions. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  2. The impact of chest compression rates on quality of chest compressions : a manikin study

    OpenAIRE

    Field, Richard A.; Soar, Jasmeet; Davies, Robin P.; Akhtar, Naheed; Perkins, Gavin D.

    2012-01-01

    Purpose\\ud Chest compressions are often performed at a variable rate during cardiopulmonary resuscitation (CPR). The effect of compression rate on other chest compression quality variables (compression depth, duty-cycle, leaning, performance decay over time) is unknown. This randomised controlled cross-over manikin study examined the effect of different compression rates on the other chest compression quality variables.\\ud Methods\\ud Twenty healthcare professionals performed two minutes of co...

  3. Influence of geometry of thermal manikins on concentration distribution and personal exposure

    DEFF Research Database (Denmark)

    Melikov, Arsen Krikor; Kaczmarczyk, Jan

    2007-01-01

    The analyses performed in this paper reveal that a breathing thermal manikin with realistic simulation of respiration including breathing cycle, pulmonary ventilation rate, frequency and breathing mode, gas concentration, humidity and temperature of exhaled air and human body shape and surface...... temperature is sensitive enough to perform reliable measurement of characteristics of air as inhaled by occupants. The temperature, humidity, and pollution concentration in the inhaled air can be measured accurately with a thermal manikin without breathing simulation if they are measured at the upper lip...... at a distance of simulation of breathing, especially of exhalation, is needed for studying the transport of exhaled air between occupants. A method...

  4. The Importance of a Thermal Manikin as Source and Obstacle in Full-Scale Experiments

    DEFF Research Database (Denmark)

    Nielsen, Peter V.

    The thermal manikin is normally introduced at indoor environmental measurements to obtain detailed information on thermal comfort and air quality around a person. This paper deals with the opposite situation where manikins are introduced as sources and obstacles in order to obtain reasonable...... boundary conditions in experiments with the indoor environment. In other words, how will people influence the surroundings instead of how will the surroundings influence people? The use of thermal manikins in an experiment will of course take both situations into account, however, in some experiments...

  5. Videolaryngoscopes differ substantially in illumination of the oral cavity: A manikin study

    Directory of Open Access Journals (Sweden)

    Barbe MA Pieters

    2016-01-01

    Full Text Available Background and Aims: Insufficient illumination of the oral cavity during endotracheal intubation may result in suboptimal conditions. Consequently, suboptimal illumination and laryngoscopy may lead to potential unwanted trauma to soft tissues of the pharyngeal mucosa. We investigated illumination of the oral cavity by different videolaryngoscopes (VLS in a manikin model. Methods: We measured light intensity from the mouth opening of a Laerdal intubation trainer comparing different direct and indirect VLS at three occasions, resembling optimal to less-than-optimal intubation conditions; at the photographer′s dark room, in an operating theatre and outdoors in bright sunlight. Results: Substantial differences in luminance were detected between VLS. The use of LED light significantly improved light production. All VLS produced substantial higher luminance values in a well-luminated environment compared to the dark photographer′s room. The experiments outside-in bright sunlight-were interfered with by direct sunlight penetration through the synthetic material of the manikin, making correct measurement of luminance in the oropharynx invalid. Conclusion: Illumination of the oral cavity differs widely among direct and indirect VLS. The clinician should be aware of the possibility of suboptimal illumination of the oral cavity and the potential risk this poses for the patient.

  6. Measurement and prediction of indoor air quality using a breathing thermal manikin

    DEFF Research Database (Denmark)

    Melikov, Arsen Krikor; Kaczmarczyk, J.

    2007-01-01

    temperature is sensitive enough to perform reliable measurement of characteristics of air as inhaled by occupants. The temperature, humidity, and pollution concentration in the inhaled air can be measured accurately with a thermal manikin without breathing simulation if they are measured at the upper lip...... at a distance of measured inhaled air parameters. Proper simulation of breathing, especially of exhalation, is needed for studying the transport of exhaled air between occupants. A method......The analyses performed in this paper reveal that a breathing thermal manikin with realistic simulation of respiration including breathing cycle, pulmonary ventilation rate, frequency and breathing mode, gas concentration, humidity and temperature of exhaled air and human body shape and surface...

  7. Does a 4 diagram manual enable laypersons to operate the laryngeal mask supreme®? A pilot study in the manikin

    Directory of Open Access Journals (Sweden)

    Schälte Gereon

    2012-03-01

    Full Text Available Abstract Background Bystander resuscitation plays an important role in lifesaving cardiopulmonary resuscitation (CPR. A significant reduction in the "no-flow-time", quantitatively better chest compressions and an improved quality of ventilation can be demonstrated during CPR using supraglottic airway devices (SADs. Previous studies have demonstrated the ability of inexperienced persons to operate SADs after brief instruction. The aim of this pilot study was to determine whether an instruction manual consisting of four diagrams enables laypersons to operate a Laryngeal Mask Supreme® (LMAS in the manikin. Methods An instruction manual of four illustrations with speech bubbles displaying the correct use of the LMAS was designed. Laypersons were handed a bag containing a LMAS, a bag mask valve device (BMV, a syringe prefilled with air and the instruction sheet, and were asked to perform and ventilate the manikin as displayed. Time to ventilation was recorded and degree of success evaluated. Results A total of 150 laypersons took part. Overall 145 participants (96.7% inserted the LMAS in the manikin in the right direction. The device was inserted inverted or twisted in 13 (8.7% attempts. Eight (5.3% individuals recognized this and corrected the position. Within the first 2 minutes 119 (79.3% applicants were able to insert the LMAS and provide tidal volumes greater than 150 ml (estimated dead space. Time to insertion and first ventilation was 83.2 ± 29 s. No significant difference related to previous BLS training (P = 0.85, technical education (P = 0.07 or gender could be demonstrated (P = 0.25. Conclusion In manikin laypersons could insert LMAS in the correct direction after onsite instruction by a simple manual with a high success rate. This indicates some basic procedural understanding and intellectual transfer in principle. Operating errors (n = 91 were frequently not recognized and corrected (n = 77. Improvements in labeling and the quality of

  8. MANIKIN DEMONSTRATION IN TEACHING CONSERVATIVE MANAGEMENT OF POSTPARTUM HAEMORRHAGE: A COMPARISON WITH CONVENTIONAL METHODS

    Directory of Open Access Journals (Sweden)

    Sathi Mangalam Saraswathi

    2016-07-01

    Full Text Available BACKGROUND Even though there are many innovative methods to make classes more interesting and effective, in my department, topics are taught mainly by didactic lectures. This study attempts to compare the effectiveness of manikin demonstration and didactic lectures in teaching conservative management of post-partum haemorrhage. OBJECTIVE To compare the effectiveness of manikin demonstration and didactic lectures in teaching conservative management of postpartum haemorrhage. MATERIALS AND METHODS This is an observational study. Eighty four ninth-semester MBBS students posted in Department of Obstetrics and Gynaecology, Government Medical College, Kottayam were selected. They were divided into 2 groups by lottery method. Pre-test was conducted for both groups. Group A was taught by manikin demonstration. Group B was taught by didactic lecture. Feedback response from the students collected after demonstration class was analysed. Post-test was conducted for both the groups after one week. Gain in knowledge of both the groups were calculated from pre-test and post-test scores and compared by Independent sample t test. RESULTS The mean gain in knowledge in group A was 6.4 when compared to group B which is 4.3 and the difference was found to be statistically significant. All of the students in group A felt satisfied and more confident after the class and wanted more topics to be taken by demonstration. CONCLUSION Manikin demonstration class is more effective in teaching conservative management of post-partum haemorrhage and this method can be adopted to teach similar topics in clinical subjects.

  9. Measuring the thermal insulation and evaporative resistance of sleeping bags using a supine sweating fabric manikin

    International Nuclear Information System (INIS)

    Wu, Y S; Fan, Jintu

    2009-01-01

    For testing the thermal insulation of sleeping bags, standard test methods and procedures using heated manikins are provided in ASTM F1720-06 and EN 13537:2002. However, with regard to the evaporative resistance of sleeping bags, no instrument or test method has so far been established to give a direct measurement. In this paper, we report on a novel supine sweating fabric manikin system for directly measuring the evaporative resistance of sleeping bags. Eleven sleeping bags were tested using the manikin under the isothermal condition, namely, both the mean skin temperature of the manikin and that of the environment were controlled to be the same at 35 °C, with the wind speed and ambient relative humidity at 0.3 m s −1 and 50%, respectively. The results showed that the novel supine sweating fabric manikin is reproducible and accurate in directly measuring the evaporative resistance of sleeping bags, and the measured evaporative resistance can be combined with thermal insulation to calculate the moisture permeability index of sleeping bags

  10. Manikin-Based Size-Resolved Penetrations of CE-marked Filtering Facepiece Respirators.

    Czech Academy of Sciences Publication Activity Database

    Serfozo, N.; Ondráček, Jakub; Otáhal, P.; Lazaridis, M.; Ždímal, Vladimír

    2017-01-01

    Roč. 14, č. 12 (2017), s. 965-974 ISSN 1545-9624 EU Projects: European Commission(XE) 315760 - HEXACOMM Institutional support: RVO:67985858 Keywords : size-resolved penetration * manikin-based study * CE-marked respirator Subject RIV: CF - Physical ; Theoretical Chemistry OBOR OECD: Physical chemistry Impact factor: 1.200, year: 2016

  11. An Appropriate Compression Pace is Important for Securing the Quality of Hands-only CPR : A manikin study

    OpenAIRE

    Shimizu, Yoshitaka; Tanigawa, Koichi; Ishikawa, Masami; Ouhara, Kazuhisa; Oue, Kana; Yoshinaka, Taiga; Kurihara, Hidemi; Irifune, Masahiro

    2014-01-01

    It is important to implement good quality chest compressions for cardiopulmonary resuscitation (CPR). This manikin study examined the effects of different compression rates on chest compression depth variables using a metronome sound guide. Fifty sixth-year dentistry students participated in the study. Each participant performed CPR at 3 different compression rates, 110, 100, and 90 compressions per min (pace-110-g, pace-100-g, and pace-90-g) for 2 consecutive one-minute sets with a ten-secon...

  12. Evaluating local and overall thermal comfort in buildings using thermal manikins

    Energy Technology Data Exchange (ETDEWEB)

    Foda, E.

    2012-07-01

    Evaluation methods of human thermal comfort that are based on whole-body heat balance with its surroundings may not be adequate for evaluations in non-uniform thermal conditions. Under these conditions, the human body's segments may experience a wide range of room physical parameters and the evaluation of the local (segmental) thermal comfort becomes necessary. In this work, subjective measurements of skin temperature were carried out to investigate the human body's local responses due to a step change in the room temperature; and the variability in the body's local temperatures under different indoor conditions and exposures as well as the physiological steady state local temperatures. Then, a multi-segmental model of human thermoregulation was developed based on these findings to predict the local skin temperatures of individuals' body segments with a good accuracy. The model predictability of skin temperature was verified for steady state and dynamic conditions using measured data at uniform neutral, cold and warm as well as different asymmetric thermal conditions. The model showed very good predictability with average absolute deviation ranged from 0.3-0.8 K. The model was then implemented onto the control system of the thermal manikin 'THERMINATOR' to adjust the segmental skin temperature set-points based on the indoor conditions. This new control for the manikin was experimentally validated for the prediction of local and overall thermal comfort using the equivalent temperature measure. THERMINATOR with the new control mode was then employed in the evaluation of localized floor-heating system variants towards maximum energy efficiency. This aimed at illustrating a design strategy using the thermal manikin to find the optimum geometry and surface area of a floor-heater for a single seated person. Furthermore, a psychological comfort model that is based on local skin temperature was adapted for the use with the model of human

  13. Comparison of face masks in the bag-mask ventilation of a manikin.

    Science.gov (United States)

    Redfern, D; Rassam, S; Stacey, M R; Mecklenburgh, J S

    2006-02-01

    We conducted a study investigating the effectiveness of four face mask designs in the bag-mask ventilation of a special manikin adapted to simulate a difficult airway. Forty-eight anaesthetists volunteered to bag-mask ventilate the manikin for 3 min with four different face masks. The primary outcome of the study was to calculate mean percentage leak from the face masks over 3 min. Anaesthetists were also asked to rate the face masks using a visual analogue score. The single-use scented intersurgical face mask had the lowest mean leak (20%). This was significantly lower than the mean leak from the single-use, cushioned 7,000 series Air Safety Ltd. face mask (24%) and the reusable silicone Laerdal face mask (27%) but not significantly lower than the mean leak from the reusable anatomical intersurgical face mask (23%). There was a large variation in both performance and satisfaction between anaesthetists with each design. This highlights the importance of having a variety of face masks available for emergency use.

  14. Pengembangan Pintu Air Irigasi Pintar berbasis Arduino untuk Daerah Irigasi Manikin

    Directory of Open Access Journals (Sweden)

    Folkes Eduward Laumal

    2017-12-01

    Full Text Available In general, irrigation watergates placed in the Manikin Irrigation Area is supporting tools for agricultural activities that implement a primary–secondary–tertiary channel system. Manikin irrigation watergate is made of iron plates with the certain size which is operated by a move up/down or rotation. This mechanism has led the dissatisfaction service problems in farmers. This study has developed smart irrigation watergate based on Arduino by replacing the lifter/rotator part using DC motor that works automatically based on the Real-time Clock sensor. This sensor sends the data time to Arduino and used as the reference to open or close the watergate. The study used a design method includes interconnecting realtime clock sensors and Arduino, build the programming control, build the DC system on watergates and interconnection to control systems and testing. The test results show that the irrigation watergate moves up and move down every 2 hours based on the data time from the real-time clock, works with a 12-hour time format and operating on 2.7-ampere current.

  15. Disseminating cardiopulmonary resuscitation training by distributing 9,200 personal manikins.

    Science.gov (United States)

    de Paiva, Edison Ferreira; Padilha, Roberto de Queiroz; Sgobero, Jenny Karol Gomes Sato; Ganem, Fernando; Cardoso, Luiz Francisco

    2014-08-01

    Community members should be trained so that witnesses of cardiac arrests are able to trigger the emergency system and perform adequate resuscitation. In this study, the authors evaluated the results of cardiopulmonary resuscitation (CPR) training of communities in four Brazilian cities, using personal resuscitation manikins. In total, 9,200 manikins were distributed in Apucarana, Itanhaém, Maringá, and São Carlos, which are cities where the populations range from 80,000 to 325,000 inhabitants. Elementary and secondary school teachers were trained on how to identify a cardiac arrest, trigger the emergency system, and perform chest compressions. The teachers were to transfer the training to their students, who would then train their families and friends. In total, 49,131 individuals were trained (6.7% of the population), but the original strategy of using teachers and students as multipliers was responsible for only 27.9% of the training. A total of 508 teachers were trained, and only 88 (17.3%) transferred the training to the students. Furthermore, the students have trained only 45 individuals of the population. In Maringá and São Carlos, the strategy was changed and professionals in the primary health care system were prepared and used as multipliers. This strategy proved extremely effective, especially in Maringá, where 39,041 individuals were trained (79.5% of the total number of trainings). Community health care providers were more effective in passing the training to students than the teachers (odds ratio [OR] = 7.12; 95% confidence interval [CI] = 4.74 to 10.69; p CPR using personal manikins by professionals in the primary health care system seems to be a more efficient strategy for training the community than creating a training network in the schools. © 2014 by the Society for Academic Emergency Medicine.

  16. Meet TOM - the world's first open chest paediatric/adult manikin.

    Science.gov (United States)

    Dix, Ann

    2016-07-20

    Aged 15, TOM is a model patient. He has suffered more than his fair share of life-threatening events and never complains. But then TOM is not your average sick teenager - he is the world's first open chest paediatric/adult manikin.

  17. Does real-time objective feedback and competition improve performance and quality in manikin CPR training--a prospective observational study from several European EMS.

    Science.gov (United States)

    Smart, J R; Kranz, K; Carmona, F; Lindner, T W; Newton, A

    2015-10-15

    Previous studies have reported that the quality of cardiopulmonary resuscitation (CPR) is important for patient survival. Real time objective feedback during manikin training has been shown to improve CPR performance. Objective measurement could facilitate competition and help motivate participants to improve their CPR performance. The aims of this study were to investigate whether real time objective feedback on manikins helps improve CPR performance and whether competition between separate European Emergency Medical Services (EMS) and between participants at each EMS helps motivation to train. Ten European EMS took part in the study and was carried out in two stages. At Stage 1, each EMS provided 20 pre-hospital professionals. A questionnaire was completed and standardised assessment scenarios were performed for adult and infant out of hospital cardiac arrest (OHCA). CPR performance was objectively measured and recorded but no feedback given. Between Stage 1 and 2, each EMS was given access to manikins for 6 months and instructed on how to use with objective real-time CPR feedback available. Stage 2 was undertaken and was a repeat of Stage 1 with a questionnaire with additional questions relating to usefulness of feedback and the competition nature of the study (using a 10 point Likert score). The EMS that improved the most from Stage 1 to Stage 2 was declared the winner. An independent samples Student t-test was used to analyse the objective CPR metrics with the significance level taken as p Competition between EMS organisations recorded a mean score of 5.8 and competition between participants recorded a mean score of 6.0. The results suggest that the use of real time objective feedback can significantly help improve CPR performance. Competition, especially between participants, appeared to encourage staff to practice and this study suggests that competition might have a useful role to help motivate staff to perform CPR training.

  18. Comparative Assessment of Torso and Seat Mounted Restraint Systems using Manikins on the Vertical Deceleration Tower

    Science.gov (United States)

    2017-03-01

    AFRL-RH-WP-TR-2017-0044 Comparative Assessment of Torso and Seat Mounted Restraint Systems using Manikins on the Vertical ...Restraint Systems using Manikins on the Vertical Deceleration Tower 5a. CONTRACT NUMBER FA8650-14-D-6500-0001 5b. GRANT NUMBER 5c. PROGRAM...experimental effort involving a series of +z-axis impact tests was conducted on the 711th Human Performance Wing’s Vertical Deceleration Tower (VDT

  19. Interpersonal Transport of Expiratory Aerosols among Three Manikins in a Full-Scale Test Room

    DEFF Research Database (Denmark)

    Liu, Li; Nielsen, Peter Vilhelm; Jensen, Rasmus Lund

    2014-01-01

    This study focuses on occupants’ exposure of aerosols exhaled by one susceptible in a full-scale test room. Three breathing thermal manikins are standing in the middle of room and both the process in the microenvironment and in the macroenvironment are considered. A diffusive ceiling has been...

  20. the comfort, measured by means of a sweating manikin (waltertm)

    African Journals Online (AJOL)

    user

    With the growing importance of clothing comfort in South African and overseas markets for locally produced clothing, the Council for. Scientific Industrial Research (CSIR) acquired an advanced sweating fabric manikin for measuring clothing comfort. This preliminary investigation covers the comfort related properties, as ...

  1. Interpersonal Transport of Droplet Nuclei among Three Manikins in a Full-Scale Test Room

    DEFF Research Database (Denmark)

    Liu, Li; Nielsen, Peter Vilhelm; Jensen, Rasmus Lund

    2014-01-01

    This study focuses on occupants’ exposure of droplet nuclei exhaled by one susceptible in a full-scale test room. Three breathing thermal manikins are standing in the middle of room and both the process in the microenvironment and in the macroenvironment are considered. A diffusive ceiling has been...

  2. The impact of chest compression rates on quality of chest compressions - a manikin study.

    Science.gov (United States)

    Field, Richard A; Soar, Jasmeet; Davies, Robin P; Akhtar, Naheed; Perkins, Gavin D

    2012-03-01

    Chest compressions are often performed at a variable rate during cardiopulmonary resuscitation (CPR). The effect of compression rate on other chest compression quality variables (compression depth, duty-cycle, leaning, performance decay over time) is unknown. This randomised controlled cross-over manikin study examined the effect of different compression rates on the other chest compression quality variables. Twenty healthcare professionals performed 2 min of continuous compressions on an instrumented manikin at rates of 80, 100, 120, 140 and 160 min(-1) in a random order. An electronic metronome was used to guide compression rate. Compression data were analysed by repeated measures ANOVA and are presented as mean (SD). Non-parametric data was analysed by Friedman test. At faster compression rates there were significant improvements in the number of compressions delivered (160(2) at 80 min(-1) vs. 312(13) compressions at 160 min(-1), P<0.001); and compression duty-cycle (43(6)% at 80 min(-1) vs. 50(7)% at 160 min(-1), P<0.001). This was at the cost of a significant reduction in compression depth (39.5(10)mm at 80 min(-1) vs. 34.5(11)mm at 160 min(-1), P<0.001); and earlier decay in compression quality (median decay point 120 s at 80 min(-1) vs. 40s at 160 min(-1), P<0.001). Additionally not all participants achieved the target rate (100% at 80 min(-1) vs. 70% at 160 min(-1)). Rates above 120 min(-1) had the greatest impact on reducing chest compression quality. For Guidelines 2005 trained rescuers, a chest compression rate of 100-120 min(-1) for 2 min is feasible whilst maintaining adequate chest compression quality in terms of depth, duty-cycle, leaning, and decay in compression performance. Further studies are needed to assess the impact of the Guidelines 2010 recommendation for deeper and faster chest compressions. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  3. Natural convection heat transfer coefficient for newborn baby - Thermal manikin assessed convective heat loses

    Science.gov (United States)

    Ostrowski, Ziemowit; Rojczyk, Marek

    2017-11-01

    The energy balance and heat exchange for newborn baby in radiant warmer environment are considered. The present study was performed to assess the body dry heat loss from an infant in radiant warmer, using copper cast anthropomorphic thermal manikin and controlled climate chamber laboratory setup. The total body dry heat losses were measured for varying manikin surface temperatures (nine levels between 32.5 °C and 40.1 °C) and ambient air temperatures (five levels between 23.5 °C and 29.7 °C). Radiant heat losses were estimated based on measured climate chamber wall temperatures. After subtracting radiant part, resulting convective heat loses were compared with computed ones (based on Nu correlations for common geometries). Simplified geometry of newborn baby was represented as: (a) single cylinder and (b) weighted sum of 5 cylinders and sphere. The predicted values are significantly overestimated relative to measured ones by: 28.8% (SD 23.5%) for (a) and 40.9% (SD 25.2%) for (b). This showed that use of adopted general purpose correlations for approximation of convective heat losses of newborn baby can lead to substantial errors. Hence, new Nu number correlating equation is proposed. The mean error introduced by proposed correlation was reduced to 1.4% (SD 11.97%), i.e. no significant overestimation. The thermal manikin appears to provide a precise method for the noninvasive assessment of thermal conditions in neonatal care.

  4. Two-thumb technique is superior to two-finger technique during lone rescuer infant manikin CPR.

    Science.gov (United States)

    Udassi, Sharda; Udassi, Jai P; Lamb, Melissa A; Theriaque, Douglas W; Shuster, Jonathan J; Zaritsky, Arno L; Haque, Ikram U

    2010-06-01

    Infant CPR guidelines recommend two-finger chest compression with a lone rescuer and two-thumb with two rescuers. Two-thumb provides better chest compression but is perceived to be associated with increased ventilation hands-off time. We hypothesized that lone rescuer two-thumb CPR is associated with increased ventilation cycle time, decreased ventilation quality and fewer chest compressions compared to two-finger CPR in an infant manikin model. Crossover observational study randomizing 34 healthcare providers to perform 2 min CPR at a compression rate of 100 min(-1) using a 30:2 compression:ventilation ratio comparing two-thumb vs. two-finger techniques. A Laerdal Baby ALS Trainer manikin was modified to digitally record compression rate, compression depth and compression pressure and ventilation cycle time (two mouth-to-mouth breaths). Manikin chest rise with breaths was video recorded and later reviewed by two blinded CPR instructors for percent effective breaths. Data (mean+/-SD) were analyzed using a two-tailed paired t-test. Significance was defined qualitatively as pCPR, but there was no significant difference in percent effective breaths delivered between the two techniques. Two-thumb CPR had 4 fewer delivered compressions per minute, which may be offset by far more effective compression depth and compression pressure compared to two-finger technique. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

  5. Thermal comfort sustained by cold protective clothing in Arctic open-pit mining-a thermal manikin and questionnaire study.

    Science.gov (United States)

    Jussila, Kirsi; Rissanen, Sirkka; Aminoff, Anna; Wahlström, Jens; Vaktskjold, Arild; Talykova, Ljudmila; Remes, Jouko; Mänttäri, Satu; Rintamäki, Hannu

    2017-12-07

    Workers in the Arctic open-pit mines are exposed to harsh weather conditions. Employers are required to provide protective clothing for workers. This can be the outer layer, but sometimes also inner or middle layers are provided. This study aimed to determine how Arctic open-pit miners protect themselves against cold and the sufficiency, and the selection criteria of the garments. Workers' cold experiences and the clothing in four Arctic open-pit mines in Finland, Sweden, Norway and Russia were evaluated by a questionnaire (n=1,323). Basic thermal insulation (I cl ) of the reported clothing was estimated (ISO 9920). The I cl of clothing from the mines were also measured by thermal manikin (standing/walking) in 0.3 and 4.0 m/s wind. The questionnaire showed that the I cl of the selected clothing was on average 1.2 and 1.5 clo in mild (-5 to +5°C) and dry cold (-20 to -10°C) conditions, respectively. The I cl of the clothing measured by thermal manikin was 1.9-2.3 clo. The results show that the Arctic open-pit miners' selected their clothing based on occupational (time outdoors), environmental (temperature, wind, moisture) and individual factors (cold sensitivity, general health). However, the selected clothing was not sufficient to prevent cooling completely at ambient temperatures below -10°C.

  6. Accurate feedback of chest compression depth on a manikin on a soft surface with correction for total body displacement

    NARCIS (Netherlands)

    Beesems, Stefanie G.; Koster, Rudolph W.

    2014-01-01

    TrueCPR is a new real-time compression depth feedback device that measures changes in magnetic field strength between a back pad and a chest pad. We determined its accuracy with a manikin on a test bench and on various surfaces. First, calibration and accuracy of the manikin and TrueCPR was verified

  7. Evaluation of the Efficiency of Liquid Cooling Garments using a Thermal Manikin

    National Research Council Canada - National Science Library

    Xu, Xiaojiang; Endrusick, Thomas; Gonzalez, Julio; Laprise, Brad; Teal, Walter; Santee, William; Kolka, Margaret

    2005-01-01

    .... personal protective equipment), and environmental conditions. Thermal manikins (TM) have been used to evaluate the performance of LCG systems and to determine the amount of heat that a LCG can extract from a TM...

  8. An appropriate compression pace is important for securing the quality of hands-only CPR--a manikin study.

    Science.gov (United States)

    Shimizu, Yoshitaka; Tanigawa, Koichi; Ishikawa, Masami; Ouhara, Kazuhisa; Oue, Kana; Yoshinaka, Taiga; Kurihara, Hidemi; Irifune, Masahiro

    2014-09-01

    It is important to implement good quality chest compressions for cardiopulmonary resuscitation (CPR). This manikin study examined the effects of different compression rates on chest compression depth variables using a metronome sound guide. Fifty sixth-year dentistry students participated in the study. Each participant performed CPR at 3 different compression rates, 110, 100, and 90 compressions per min (pace-110-g, pace-100-g, and pace-90-g) for 2 consecutive one-minute sets with a ten-second break between the sets. The percentage of compressions deeper than 5 cm at pace-110-g decreased significantly from 22.1 ± 4.7% in the first set to 16.7 ± 4.4%* in the second set (*p CPR.

  9. The effects of non-invasive respiratory support on oropharyngeal temperature and humidity: a neonatal manikin study.

    Science.gov (United States)

    Roberts, Calum T; Kortekaas, Rebecca; Dawson, Jennifer A; Manley, Brett J; Owen, Louise S; Davis, Peter G

    2016-05-01

    Heating and humidification of inspired gases is routine during neonatal non-invasive respiratory support. However, little is known about the temperature and humidity delivered to the upper airway. The International Standards Organization (ISO) specifies that for all patients with an artificial airway humidifiers should deliver ≥33 g/m(3) absolute humidity (AH). We assessed the oropharyngeal temperature and humidity during different non-invasive support modes in a neonatal manikin study. Six different modes of non-invasive respiratory support were applied at clinically relevant settings to a neonatal manikin, placed in a warmed and humidified neonatal incubator. Oropharyngeal temperature and relative humidity (RH) were assessed using a thermohygrometer. AH was subsequently calculated. Measured temperature and RH varied between devices. Bubble and ventilator continuous positive airway pressure (CPAP) produced temperatures >34°C and AH >38 g/m(3). Variable flow CPAP resulted in lower levels of AH than bubble or ventilator CPAP, and AH decreased with higher gas flow. High-flow (HF) therapy delivered by Optiflow Junior produced higher AH with higher gas flow, whereas with Vapotherm HF the converse was true. Different non-invasive devices deliver inspiratory gases of variable temperature and humidity. Most AH levels were above the ISO recommendation; however, with some HF and variable flow CPAP devices at higher gas flow this was not achieved. Clinicians should be aware of differences in the efficacy of heating and humidification when choosing modes of non-invasive respiratory support. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  10. Quality control and data-handling in multicentre studies: the case of the Multicentre Project for Tuberculosis Research

    Directory of Open Access Journals (Sweden)

    Caloto Teresa

    2001-12-01

    Full Text Available Abstract Background The Multicentre Project for Tuberculosis Research (MPTR was a clinical-epidemiological study on tuberculosis carried out in Spain from 1996 to 1998. In total, 96 centres scattered all over the country participated in the project, 19935 "possible cases" of tuberculosis were examined and 10053 finally included. Data-handling and quality control procedures implemented in the MPTR are described. Methods The study was divided in three phases: 1 preliminary phase, 2 field work 3 final phase. Quality control procedures during the three phases are described. Results: Preliminary phase: a organisation of the research team; b design of epidemiological tools; training of researchers. Field work: a data collection; b data computerisation; c data transmission; d data cleaning; e quality control audits; f confidentiality. Final phase: a final data cleaning; b final analysis. Conclusion The undertaking of a multicentre project implies the need to work with a heterogeneous research team and yet at the same time attain a common goal by following a homogeneous methodology. This demands an additional effort on quality control.

  11. An assessment of the realism of digital human manikins used for simulation in ergonomics.

    Science.gov (United States)

    Nérot, Agathe; Skalli, Wafa; Wang, Xuguang

    2015-01-01

    In this study, the accuracy of the joint centres of the manikins generated by RAMSIS and Human Builder (HB), two digital human modelling (DHM) systems widely used in industry for virtual ergonomics simulation, was investigated. Eighteen variously sized females and males were generated from external anthropometric dimensions and six joint centres (knee, hip and four spine joints) were compared with their anatomic locations obtained from the three-dimensional reconstructed bones from a low-dose X-ray system. Both RAMSIS and HB could correctly reproduce external anthropometric dimensions, while the estimation of internal joint centres location presented an average error of 27.6 mm for HB and 38.3 mm for RAMSIS. Differences between both manikins showed that a more realistic kinematic linkage led to better accuracy in joint location. This study opens the way to further research on the relationship between the external body geometry and internal skeleton in order to improve the realism of the internal skeleton of DHMs, especially for a biomechanical analysis requiring information of joint load and muscle force estimation. This study assessed two digital human modelling (DHM) systems widely used in industry for virtual ergonomics. Results support the need of a more realistic human modelling, especially for a biomechanical analysis and a standardisation of DHMs.

  12. Breathing thermal manikin for indoor environment assessment: Important characteristics and requirements

    DEFF Research Database (Denmark)

    Melikov, Arsen Krikor

    2003-01-01

    Recently breathing thermal manikins have been developed and used for indoor environment measurement, evaluation and optimization as well as validation of Computational Fluid Dynamics (CFD) predictions of airflow around a human body. Advances in the assessment of occupants¿ thermal comfort...... and shape of body segments, control mode, breathing simulation, etc. are discussed and specified in this paper....

  13. What is the best clothing to prevent heat and cold stress? Experiences with thermal manikin.

    Science.gov (United States)

    Magyar, Z; Tamas, R

    2013-02-01

    The present study summarizes the current knowledge of the heat and cold stress which might significantly affect military activities and might also occur among travellers who are not well adapted to weather variations during their journey. The selection of the best clothing is a very important factor in preserving thermal comfort. Our experiences with thermal manikin are also represented in this paper.

  14. Effect of socioemotional stress on the quality of cardiopulmonary resuscitation during advanced life support in a randomized manikin study.

    Science.gov (United States)

    Bjørshol, Conrad Arnfinn; Myklebust, Helge; Nilsen, Kjetil Lønne; Hoff, Thomas; Bjørkli, Cato; Illguth, Eirik; Søreide, Eldar; Sunde, Kjetil

    2011-02-01

    The aim of this study was to evaluate whether socioemotional stress affects the quality of cardiopulmonary resuscitation during advanced life support in a simulated manikin model. A randomized crossover trial with advanced life support performed in two different conditions, with and without exposure to socioemotional stress. The study was conducted at the Stavanger Acute Medicine Foundation for Education and Research simulation center, Stavanger, Norway. Paramedic teams, each consisting of two paramedics and one assistant, employed at Stavanger University Hospital, Stavanger, Norway. A total of 19 paramedic teams performed advanced life support twice in a randomized fashion, one control condition without socioemotional stress and one experimental condition with exposure to socioemotional stress. The socioemotional stress consisted of an upset friend of the simulated patient who was a physician, spoke a foreign language, was unfamiliar with current Norwegian resuscitation guidelines, supplied irrelevant clinical information, and repeatedly made doubts about the paramedics' resuscitation efforts. Aural distractions were supplied by television and cell telephone. The primary outcome was the quality of cardiopulmonary resuscitation: chest compression depth, chest compression rate, time without chest compressions (no-flow ratio), and ventilation rate after endotracheal intubation. As a secondary outcome, the socioemotional stress impact was evaluated through the paramedics' subjective workload, frustration, and feeling of realism. There were no significant differences in chest compression depth (39 vs. 38 mm, p = .214), compression rate (113 vs. 116 min⁻¹, p = .065), no-flow ratio (0.15 vs. 0.15, p = .618), or ventilation rate (8.2 vs. 7.7 min⁻¹, p = .120) between the two conditions. There was a significant increase in the subjective workload, frustration, and feeling of realism when the paramedics were exposed to socioemotional stress. In this advanced life

  15. Manikin for assessment of MP3 player exposure

    DEFF Research Database (Denmark)

    Hammershøi, Dorte

    2007-01-01

    Contemporary personal stereo players are compact, easy to use, and provide intense, high-quality sound that can be heard anywhere anytime. The players are reasonable in price, and have become very popular among children and adolescents. Little is known about listening habits among children...... in the belly, and a display on front that shows listening level (Laeq) according to ISO 11904-2. The scale also indicates how long one can listen at that given level without exceeding a workday exposure level of 80 dBA. The manikin has proven useful as a tool for mediation, and may even (in a revised version...

  16. Laypersons may learn basic life support in 24min using a personal resuscitation manikin

    DEFF Research Database (Denmark)

    Isbye, Dan Lou; Rasmussen, Lars Simon; Lippert, Freddy Knudsen

    2006-01-01

    -training. The second group attended a conventional 6 h BLS course (6 HR). After 3 months BLS skills were assessed on a Laerdal ResusciAnne manikin using the Laerdal PC Skill reporting System, and a total score was calculated. RESULTS: There was no significant difference between groups in BLS performance using...... assessed after 3 months, a 24 min DVD-based instruction plus subsequent self-training in BLS appears equally effective compared to a 6h BLS course and hence is more efficient. Udgivelsesdato: 2006-Jun...... and the challenge is to find the most efficient one. AIMS: To compare the efficiency of a 24 min instruction using a DVD-based self-training BLS course combined with a simple, take-home resuscitation manikin to a conventional 6h course for teaching BLS to laypersons. METHODS: In total, 238 laypersons (age 21...

  17. Loss to follow-up in an international, multicentre observational study

    DEFF Research Database (Denmark)

    Mocroft, A; Kirk, O; Aldins, P

    2008-01-01

    OBJECTIVE: The aim of this work was to assess loss to follow-up (LTFU) in EuroSIDA, an international multicentre observational cohort study. METHODS: LTFU was defined as no follow-up visit, CD4 cell count measurement or viral load measurement after 1 January 2006. Poisson regression was used...

  18. Multicentre European study of thalamic stimulation in parkinsonian and essential tremor

    NARCIS (Netherlands)

    Limousin, P.; Speelman, J. D.; Gielen, F.; Janssens, M.

    1999-01-01

    Thalamic stimulation has been proposed to treat disabling tremor. The aims of this multicentre study were to evaluate the efficacy and the morbidity of thalamic stimulation in a large number of patients with parkinsonian or essential tremor. One hundred and eleven patients were included in the study

  19. The Effect of Instructional Method on Cardiopulmonary Resuscitation Skill Performance: A Comparison Between Instructor-Led Basic Life Support and Computer-Based Basic Life Support With Voice-Activated Manikin.

    Science.gov (United States)

    Wilson-Sands, Cathy; Brahn, Pamela; Graves, Kristal

    2015-01-01

    Validating participants' ability to correctly perform cardiopulmonary resuscitation (CPR) skills during basic life support courses can be a challenge for nursing professional development specialists. This study compares two methods of basic life support training, instructor-led and computer-based learning with voice-activated manikins, to identify if one method is more effective for performance of CPR skills. The findings suggest that a computer-based learning course with voice-activated manikins is a more effective method of training for improved CPR performance.

  20. Comparative Assessment of Torso and Seat Mounted Restraint Systems using Manikins on the Horizontal Impulse Accelerator

    Science.gov (United States)

    2017-11-01

    ORGANIZATION ORISE** Infoscitex Corporation*** Oak Ridge Institute for Science and Education ...accelerations tested, and this was especially evident at impact accelerations greater than 10 G. The LOIS manikin head Ry angular acceleration was greater than

  1. Iohexol in investigations of the spinal canal. Multicentre study

    International Nuclear Information System (INIS)

    Bories, J.

    1988-01-01

    The author presents the results of a multicentric study of Iohexol in investigation of the spinal canal undertaken at the request of Winthrop Laboratories in 32 Radiological departments. The study involved 329 adults of both sexes. It confirmed the excellent quality of results obtained with this preparation in the literature and its excellent tolerance. On the basis of these results Iohexol may be considered to be definitely one of the best currently available preparations for investigation of the spinal canal [fr

  2. Tracheal intubation by inexperienced medical residents using the Airtraq and Macintosh laryngoscopes--a manikin study.

    LENUS (Irish Health Repository)

    Maharaj, Chrisen H

    2006-11-01

    The Airtraq laryngoscope is a novel intubation device that may possess advantages over conventional direct laryngoscopes for use by personnel that are infrequently required to perform tracheal intubation. We conducted a prospective study in 20 medical residents with little prior airway management experience. After brief didactic instruction, each participant took turns performing laryngoscopy and intubation using the Macintosh (Welch Allyn, Welch Allyn, NY) and Airtraq (Prodol Ltd. Vizcaya, Spain) devices, in 3 laryngoscopy scenarios in a Laerdal Intubation Trainer (Laerdal, Stavanger, Norway) and 1 scenario in a Laerdal SimMan manikin (Laerdal, Kent, UK). They then performed tracheal intubation of the normal airway a second time to characterize the learning curve. In all scenarios tested, the Airtraq decreased the duration of intubation attempts, reduced the number of optimization maneuvers required, and reduced the potential for dental trauma. The residents found the Airtraq easier to use in all scenarios compared with the Macintosh laryngoscope. The Airtraq may constitute a superior device for use by personnel infrequently required to perform tracheal intubation.

  3. The effect of differing support surfaces on the efficacy of chest compressions using a resuscitation manikin model.

    Science.gov (United States)

    Tweed, M; Tweed, C; Perkins, G D

    2001-11-01

    External chest compression (ECC) efficacy is influenced by factors including the surface supporting the patient. Air-filled support surfaces are deflated for cardiopulmonary resuscitation, with little evidence to substantiate this. We investigated the effect that differing support surfaces had on ECC efficacy using a CPR manikin model. Four participants carried out four cycles of ECC with an assistant ventilating. The subjects were blinded to the seven support surfaces and the order was randomised. For each participant/surface combination, ECC variables and the participants' perceptions were measured. Participants produced effective ECC with the manikin on the floor (mean proportion correct, 94.5%; mean depth, 42.5 mm). Compared with the floor: the proportion of correct ECC was less for the overlay inflated (PCPR.

  4. Perinatal complications in patients with unisutural craniosynostosis: An international multicentre retrospective cohort study

    NARCIS (Netherlands)

    Cornelissen, Martijn J.; Softeland, Madiha; Apon, Inge; Ladfors, Lars; Mathijssen, Irene M. J.; Cohen-Overbeek, Titia E.; Bonsel, Gouke J.; Kolby, Lars

    2017-01-01

    Purpose Craniosynostosis may lead to hampered fetal head molding and birth complications. To study the interaction between single suture craniosynostosis and delivery complications, an international, multicentre, retrospective cohort study was performed. Materials and methods All infants born

  5. The effectiveness of 2-implant overdentures: a pragmatic international multicentre study

    NARCIS (Netherlands)

    Rashid, F.; Awad, M.A.; Thomason, J.M.; Piovano, A.; Spielberg, G.P.; Scilingo, E.; Mojon, P.; Müller, F.; Spielberg, M.; Heydecke, G.; Stoker, G.; Wismeijer, D.; Allen, F.; Feine, J.S.

    2011-01-01

    The purpose of this multicentre observational study was to determine patient satisfaction with either conventional dentures or mandibular 2-implant overdentures in a 'real world' setting. Two hundred and three edentulous patients (mean age 68·8 ± 10·4 years) were recruited at eight centres located

  6. Nasogastric tube placement with video-guided laryngoscope: A manikin simulator study.

    Science.gov (United States)

    Lee, Xiao-Lun; Yeh, Li-Chun; Jin, Yau-Dung; Chen, Chun-Chih; Lee, Ming-Ho; Huang, Ping-Wun

    2017-08-01

    This study aimed to investigate video-guided laryngoscopy for nasogastric tube placement. This was an observational comparative study performed in a hospital. The participants included volunteers from the medical staff (physicians and nurses) experienced with nasogastric intubation, and non-medical staff (medical students, pharmacists and emergent medical technicians) with knowledge of nasogastric intubation but lacking procedural experience. Medical and non-medical hospital staff performed manual, laryngoscope-assisted and video-guided laryngoscope nasogastric intubation both in the presence and in the absence of an endotracheal tube, using a manikin. Nasogastric intubation times were compared between groups and methods. Using the video-guided laryngoscope resulted in a significantly shorter intubation time compared to the other 2 methods, both with and without an endotracheal tube, for the medical and non-medical staff alike (all p guided laryngoscope without endotracheal intubation, direct laryngoscope with endotracheal intubation and video-guided laryngoscope with endotracheal intubation compared to manual intubation without endotracheal intubation (0.49, 0.63 and 0.72 vs. 5.63, respectively, p ≤ 0.008). For non-medical staff, nasogastric intubation time was significantly shorter using video-guided laryngoscope without endotracheal intubation, direct laryngoscope with endotracheal intubation and video-guided laryngoscope with endotracheal intubation compared to manual intubation without endotracheal intubation (1.67, 1.58 and 0.95 vs. 6.9, respectively, p ≤ 0.002). And mean nasogastric intubation time for video-guided laryngoscope endotracheal intubation was significantly shorter for medical staff than for non-medical staff (0.49 vs. 1.67 min, respectively, p = 0.041). Video-guided laryngoscope reduces nasogastric intubation time compared to manual and direct laryngoscope intubation, which promotes a consistent technique when performed by

  7. Calibration in a manikin of a high dose rate equipment by remote charge

    International Nuclear Information System (INIS)

    Alfonso La Guardia, Rodolfo; Toledo Jimenez, Pablo; Pich Leon, Victor

    1996-01-01

    The aim of this study was to know the immediate results obtained with laparoscopic cholecystectomy in The use of High Dose Rate brachytherapy in Cuba has been limited to AGAT-V Soviet installations. In order to calibrate one of these installations for its clinical use, it was developed a procedure based on the direct measurement of the dose absorbed in referral point B of a paraffin manikin. Results obtained as a result of calibration are shown. According to these results, it was carried out an evaluation of the effective doses administered on prescription point A by using the linear quadratic model

  8. Development of MATLAB Scripts for the Calculation of Thermal Manikin Regional Resistance Values

    Science.gov (United States)

    2016-01-01

    TECHNICAL NOTE NO. TN16-1 DATE January 2016 ADA DEVELOPMENT OF MATLAB ® SCRIPTS FOR THE...USARIEM TECHNICAL NOTE TN16-1 DEVELOPMENT OF MATLAB ® SCRIPTS FOR THE CALCULATION OF THERMAL MANIKIN REGIONAL RESISTANCE VALUES...EXECUTIVE SUMMARY A software tool has been developed via MATLAB ® scripts to reduce the amount of repetitive and time-consuming calculations that are

  9. Violent women : A multicentre study into gender differences in forensic psychiatric patients

    NARCIS (Netherlands)

    de Vogel, Vivienne; Stam, Jeantine; Bouman, Yvonne H. A.; Ter Horst, P.R.M.; Lancel, Marike

    2016-01-01

    To gain insight into the relatively small, but increasing group of women in forensic psychiatry, a retrospective multicentre study was started gathering information from the files of 275 female patients of four Dutch forensic psychiatric hospitals on characteristics and violence risk factors.

  10. Job stress, absenteeism and coronary heart disease European cooperative study (the JACE study): Design of a multicentre prospective study

    NARCIS (Netherlands)

    Houtman, I.; Kornitzer, M.; Smet, P. de; Koyuncu, R.; Backer, G. de; Pelfrene, E.; Romon, M.; Boulenguez, C.; Ferrario, M.; Origgi, G.; Sans, S.; Perez, I.; Wilhelmsen, L.; Rosengren, A.; Isacsson, S.-O.; Östergren, P.-O.

    1999-01-01

    Background: The motives, objectives and design of a multicentre prospective study on job stress, absenteeism and coronary heart disease in Europe (the JACE study) is presented in this paper. Some specific gaps in the reviewed literature are explicitly tapped into by the JACE study. Its objectives

  11. Decay in chest compression quality due to fatigue is rare during prolonged advanced life support in a manikin model

    Directory of Open Access Journals (Sweden)

    Bjørshol Conrad A

    2011-08-01

    Full Text Available Abstract Background The aim of this study was to measure chest compression decay during simulated advanced life support (ALS in a cardiac arrest manikin model. Methods 19 paramedic teams, each consisting of three paramedics, performed ALS for 12 minutes with the same paramedic providing all chest compressions. The patient was a resuscitation manikin found in ventricular fibrillation (VF. The first shock terminated the VF and the patient remained in pulseless electrical activity (PEA throughout the scenario. Average chest compression depth and rate was measured each minute for 12 minutes and divided into three groups based on chest compression quality; good (compression depth ≥ 40 mm, compression rate 100-120/minute for each minute of CPR, bad (initial compression depth 120/minute or decay (change from good to bad during the 12 minutes. Changes in no-flow ratio (NFR, defined as the time without chest compressions divided by the total time of the ALS scenario over time was also measured. Results Based on compression depth, 5 (26%, 9 (47% and 5 (26% were good, bad and with decay, respectively. Only one paramedic experienced decay within the first two minutes. Based on compression rate, 6 (32%, 6 (32% and 7 (37% were good, bad and with decay, respectively. NFR was 22% in both the 1-3 and 4-6 minute periods, respectively, but decreased to 14% in the 7-9 minute period (P = 0.002 and to 10% in the 10-12 minute period (P Conclusions In this simulated cardiac arrest manikin study, only half of the providers achieved guideline recommended compression depth during prolonged ALS. Large inter-individual differences in chest compression quality were already present from the initiation of CPR. Chest compression decay and thereby fatigue within the first two minutes was rare.

  12. Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT)

    DEFF Research Database (Denmark)

    Madsen, M. B.; Skrede, S.; Bruun, T.

    2018-01-01

    these to patient-important outcomes. With this protocol and statistical analysis plan we describe the methods used to obtain data and the details of the planned analyses. Methods: The INFECT study is a multicentre, prospective observational cohort study. Patients with NSTIs are enrolled in five Scandinavian......Background: The INFECT project aims to advance our understanding of the pathophysiological mechanisms in necrotizing soft tissue infections (NSTIs). The INFECT observational study is part of the INFECT project with the aim of studying the clinical profile of patients with NSTIs and correlating...

  13. Multicentre Double-Blind Placebo-Controlled Food Challenge Study in Children Sensitised to Cashew Nut

    NARCIS (Netherlands)

    van der Valk, Johanna P. M.; van Wijk, Roy Gerth; Dubois, Anthony E. J.; de Groot, Hans; Reitsma, Marit; Vlieg-Boerstra, Berber; Savelkoul, Huub F. J.; Wichers, Harry J.; de Jong, Nicolette W.

    2016-01-01

    Background Few studies with a limited number of patients have provided indications that cashew-allergic patients may experience severe allergic reactions to minimal amounts of cashew nut. The objectives of this multicentre study were to assess the clinical relevance of cashew nut sensitisation, to

  14. Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

    Science.gov (United States)

    Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

    2008-08-01

    To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits

  15. The vascularised fibular graft for limb salvage after bone tumour surgery A MULTICENTRE STUDY

    NARCIS (Netherlands)

    Hilven, P. H.; Bayliss, L.; Cosker, T.; Dijkstra, P. D. S.; Jutte, P. C.; Lahoda, L. U.; Schaap, G. R.; Bramer, J. A. M.; van Drunen, G. K.; Strackee, S. D.; van Vooren, J.; Gibbons, M.; Giele, H.; van de Sande, M. A. J.

    2015-01-01

    Vascularised fibular grafts (VFGs) are a valuable surgical technique in limb salvage after resection of a tumour. The primary objective of this multicentre study was to assess the risk factors for failure and complications for using a VFG after resection of a tumour. The study involved 74

  16. Multicentre European study of thalamic stimulation for parkinsonian tremor: a 6 year follow-up

    NARCIS (Netherlands)

    Hariz, M. I.; Krack, P.; Alesch, F.; Augustinsson, L.-E.; Bosch, A.; Ekberg, R.; Johansson, F.; Johnels, B.; Meyerson, B. A.; N'Guyen, J.-P.; Pinter, M.; Pollak, P.; von Raison, F.; Rehncrona, S.; Speelman, J. D.; Sydow, O.; Benabid, A.-L.

    2008-01-01

    To evaluate the results of ventral intermediate (Vim) thalamic deep brain stimulation (DBS) in patients with tremor predominant Parkinson's disease (PD) at 6 years post surgery. This was a prolonged follow-up study of 38 patients from eight centres who participated in a multicentre study, the 1 year

  17. A comparison of four techniques of emergency transcricoid oxygenation in a manikin.

    LENUS (Irish Health Repository)

    Salah, Nazar

    2012-02-01

    Cricothyroidotomy is the final rescue maneuver in difficult airway management. We compared 4 techniques of oxygenation via the cricothyroid membrane in a manikin. The techniques were wire guided, trocar, cannula with jet ventilation, and blade technique (scalpel with endotracheal tube). In the wire-guided group, the time taken to ventilation was slower on all attempts, and there were no successful attempts in <40 seconds. There were no differences between the other groups at any time. Time to ventilation improved with repetition in all groups. Skills were retained at 1 month.

  18. A comparison of four techniques of emergency transcricoid oxygenation in a manikin.

    LENUS (Irish Health Repository)

    Salah, Nazar

    2010-04-01

    Cricothyroidotomy is the final rescue maneuver in difficult airway management. We compared 4 techniques of oxygenation via the cricothyroid membrane in a manikin. The techniques were wire guided, trocar, cannula with jet ventilation, and blade technique (scalpel with endotracheal tube). In the wire-guided group, the time taken to ventilation was slower on all attempts, and there were no successful attempts in <40 seconds. There were no differences between the other groups at any time. Time to ventilation improved with repetition in all groups. Skills were retained at 1 month.

  19. Measurement of Indoor Air Quality by Means of a Breathing Thermal Manikin

    DEFF Research Database (Denmark)

    Brohus, Henrik

    When a person is located in a contaminant field with significant gradients the contaminant distribution is modified locally due to the entrainment and transport of room air in the human convective boundary layer as well as due to the effect of the person acting as an obstacle to the flow field, etc....... The local modification of the concentration distribution may affect the personal exposure significantly and, thus, the indoor air quality actually experienced. In this paper measurements of indoor air quality by means of a Breathing Thermal Manikin (BTM) are presented....

  20. A suitability study of the fission product phantom and the bottle manikin absorption phantom for calibration of in vivo bioassay equipment for the DOELAP accreditation testing program

    International Nuclear Information System (INIS)

    Olsen, P.C.; Lynch, T.P.

    1991-08-01

    Pacific Northwest laboratory (PNL) conducted an intercomparison study of the Fission Product phantom and the bottle manikin absorption (BOMAB) phantom for the US Department of Energy (DOE) to determine the consistency of calibration response of the two phantoms and their suitability for certification and use under a planned bioassay laboratory accreditation program. The study was initiated to determine calibration factors for both types of phantoms and to evaluate the suitability of their use in DOE Laboratory Accreditation Program (DOELAP) round-robin testing. The BOMAB was found to be more appropriate for the DOELAP testing program. 9 refs., 9 figs., 9 tabs

  1. Multicentre study with activity meters launched by PTB

    International Nuclear Information System (INIS)

    Rodloff, G.

    1992-01-01

    The German Pharmacopeia tolerates for most radionuclides deviations of up to 10% from the actual activity value. The evaluation of a multicentre study launched by the PTB (Federal Physicotechnical Institute) during the period between 1982 and 1987 revealed, however, that not all producers paid attention to these tolerance limits. Occasional values were reported to differ by more than 50% or even a factor of 2 from the PTB value. In order that those deviations are kept to a minimum it is necessary for both manufacturers and users to meet the requirements of the DIN 6852 industrial standard. Activity determinations for 99 Tc m eluates must additionally be carried out in accordance with the recommendations contained in DIN 6854. (orig./DG) [de

  2. CFD Modeling of Thermal Manikin Heat Loss in a Comfort Evaluation Benchmark Test

    DEFF Research Database (Denmark)

    Nilsson, Håkan O.; Brohus, Henrik; Nielsen, Peter V.

    2007-01-01

    for comfort evaluation. The main idea is to focus on people. It is the comfort requirements of occupants that decide what thermal climate that will prevail. It is therefore important to use comfort simulation methods that originate from people, not just temperatures on surfaces and air.......Computer simulated persons (CSPs) today are different in many ways, reflecting various software possibilities and limitations as well as different research interest. Unfortunately, too few of the theories behind thermal manikin simulations are available in the public domain. Many researchers...

  3. Polymeric Materials Models in the Warrior Injury Assessment Manikin (WIAMan) Anthropomorphic Test Device (ATD) Tech Demonstrator

    Science.gov (United States)

    2017-01-01

    analytical model currently used by military vehicle analysts has been continuously updated to address the model’s inherent deficiencies and make the... model is a hyperelastic polymer model based upon statistical mechanics and the finite extensibility of a polymer chain.23 Its rheological ...ARL-TR-7927 ● JAN 2017 US Army Research Laboratory Polymeric Materials Models in the Warrior Injury Assessment Manikin (WIAMan

  4. Optimal chest compression rate in cardiopulmonary resuscitation: a prospective, randomized crossover study using a manikin model.

    Science.gov (United States)

    Lee, Seong Hwa; Ryu, Ji Ho; Min, Mun Ki; Kim, Yong In; Park, Maeng Real; Yeom, Seok Ran; Han, Sang Kyoon; Park, Seong Wook

    2016-08-01

    When performing cardiopulmonary resuscitation (CPR), the 2010 American Heart Association guidelines recommend a chest compression rate of at least 100 min, whereas the 2010 European Resuscitation Council guidelines recommend a rate of between 100 and 120 min. The aim of this study was to examine the rate of chest compression that fulfilled various quality indicators, thereby determining the optimal rate of compression. Thirty-two trainee emergency medical technicians and six paramedics were enrolled in this study. All participants had been trained in basic life support. Each participant performed 2 min of continuous compressions on a skill reporter manikin, while listening to a metronome sound at rates of 100, 120, 140, and 160 beats/min, in a random order. Mean compression depth, incomplete chest recoil, and the proportion of correctly performed chest compressions during the 2 min were measured and recorded. The rate of incomplete chest recoil was lower at compression rates of 100 and 120 min compared with that at 160 min (P=0.001). The numbers of compressions that fulfilled the criteria for high-quality CPR at a rate of 120 min were significantly higher than those at 100 min (P=0.016). The number of high-quality CPR compressions was the highest at a compression rate of 120 min, and increased incomplete recoil occurred with increasing compression rate. However, further studies are needed to confirm the results.

  5. Daily variations in air pollution and respiratory health in a multicentre study: the PEACE project.

    NARCIS (Netherlands)

    Roemer, W.; Hoek, G.; Brunekreef, B.; Haluszka, J.; Kalandidi, A.; Pekkanen, J.

    1998-01-01

    The Pollution Effects on Asthmatic Children in Europe (PEACE) study is a multicentre study of the acute effects of particles with a 50% cut-off aerodynamic diameter of 10 μm (PM10), black smoke (BS), sulphur dioxide (SO2) and nitrogen dioxide (NO2) on the respiratory health of children with chronic

  6. Comparison of blind intubation through the I-gel and ILMA Fastrach by nurses during cardiopulmonary resuscitation: a manikin study.

    Science.gov (United States)

    Melissopoulou, Theodora; Stroumpoulis, Konstantinos; Sampanis, Michail A; Vrachnis, Nikolaos; Papadopoulos, Georgios; Chalkias, Athanasios; Xanthos, Theodoros

    2014-01-01

    To investigate whether nursing staff can successfully use the I-gel and the intubating laryngeal mask Fastrach (ILMA) during cardiopulmonary resuscitation. Although tracheal intubation is considered to be the optimal method for securing the airway during cardiopulmonary resuscitation, laryngoscopy requires a high level of skill. Forty five nurses inserted the I-gel and the ILMA in a manikin, with continuous and without chest compressions. Mean intubation times for the ILMA and I-gel without chest compressions were 20.60 ± 3.27 and 18.40 ± 3.26 s, respectively (p < 0.0005). ILMA proved more successful than the I-gel regardless of compressions. Continuation of compressions caused a prolongation in intubation times for both the I-gel (p < 0.0005) and the ILMA (p < 0.0005). In this mannequin study, nursing staff can successfully intubate using the I-gel and the ILMA as conduits with comparable success rates, regardless of whether chest compressions are interrupted or not. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. Multicentre structural and functional MRI

    OpenAIRE

    Gountouna, Viktoria-Eleni

    2014-01-01

    Neuroimaging techniques are likely to continue to improve our understanding of the brain in health and disease, but studies tend to be small, based in one imaging centre and of uncertain generalisability. Multicentre imaging studies therefore have great appeal but it is not yet clear under which circumstances data from different scanners can be combined. The successful harmonisation of multiple Magnetic Resonance Imaging (MRI) machines will increase study power, flexibility and...

  8. Multicentre prospective cohort study of body mass index and postoperative complications following gastrointestinal surgery

    OpenAIRE

    Drake, T. M.; Nepogodiev, D.; Chapman, S. J.; Glasbey, J. C.; Khatri, C.; Kong, C. Y.; Claireaux, H. A.; Bath, M. F.; Mohan, M.; McNamee, L.; Kelly, M.; Mitchell, H.; Fitzgerald, J. E.; Harrison, E. M.; Bhangu, A.

    2016-01-01

    BackgroundThere is currently conflicting evidence surrounding the effects of obesity on postoperative outcomes. Previous studies have found obesity to be associated with adverse events, but others have found no association. The aim of this study was to determine whether increasing body mass index (BMI) is an independent risk factor for development of major postoperative complications.MethodsThis was a multicentre prospective cohort study across the UK and Republic of Ireland. Consecutive pati...

  9. Influence of chest compression rate guidance on the quality of cardiopulmonary resuscitation performed on manikins.

    Science.gov (United States)

    Jäntti, H; Silfvast, T; Turpeinen, A; Kiviniemi, V; Uusaro, A

    2009-04-01

    The adequate chest compression rate during CPR is associated with improved haemodynamics and primary survival. To explore whether the use of a metronome would affect also chest compression depth beside the rate, we evaluated CPR quality using a metronome in a simulated CPR scenario. Forty-four experienced intensive care unit nurses participated in two-rescuer basic life support given to manikins in 10min scenarios. The target chest compression to ventilation ratio was 30:2 performed with bag and mask ventilation. The rescuer performing the compressions was changed every 2min. CPR was performed first without and then with a metronome that beeped 100 times per minute. The quality of CPR was analysed with manikin software. The effect of rescuer fatigue on CPR quality was analysed separately. The mean compression rate between ventilation pauses was 137+/-18compressions per minute (cpm) without and 98+/-2cpm with metronome guidance (pmetronome (pmetronome guidance (p=0.09). The total number of chest compressions performed was 1022 without metronome guidance, 42% at the correct depth; and 780 with metronome guidance, 61% at the correct depth (p=0.09 for difference for percentage of compression with correct depth). Metronome guidance corrected chest compression rates for each compression cycle to within guideline recommendations, but did not affect chest compression quality or rescuer fatigue.

  10. C-MAC compared with direct laryngoscopy for intubation in patients with cervical spine immobilization: A manikin trial.

    Science.gov (United States)

    Smereka, Jacek; Ladny, Jerzy R; Naylor, Amanda; Ruetzler, Kurt; Szarpak, Lukasz

    2017-08-01

    The aim of this study was to compare C-MAC videolaryngoscopy with direct laryngoscopy for intubation in simulated cervical spine immobilization conditions. The study was designed as a prospective randomized crossover manikin trial. 70 paramedics with immobilization (Scenario A); manual inline cervical immobilization (Scenario B); cervical immobilization using cervical extraction collar (Scenario C). Scenario A: Nearly all participants performed successful intubations with both MAC and C-MAC on the first attempt (95.7% MAC vs. 100% C-MAC), with similar intubation times (16.5s MAC vs. 18s C-MAC). Scenario B: The results with C-MAC were significantly better than those with MAC (pimmobilization. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Multicentric reticulohistiocytosis (lipoid dermatoarthritis)

    International Nuclear Information System (INIS)

    Fiumicelli, A.; Bruni, L.

    1990-01-01

    The authors report their experience with 3 cases of multicentric reticulohistiocytosis observed over 6 years of outpatient radiological practice. The condition presents with the following radiological patterns: 1) clear-cut erosions of the articular surfaces, especially in the distal interphalangeal joints of the hand and in the metatarso-phalangeal joints of the feet, with symmetrical distributions (not necessarily); 2) osteolytic punched-out areas in the epiphyseal spongiosa, ranging in size from 1 mm to over 1 cm; 3) no osteoporosis, no osteoproliferative or periosteal reactions, not even in the presence of large osteoarticular destructions; 4) frequent atlanto-epistropheal subluxation; 5) articular ankylosis at the sacroiliac joints only. The association of the above patterns and the relativity benign clinical course distinguish multicentric reticulohistiocytosis from rheumatoid arthritis, psoriasic arthritis, erosive osteoarthritis, and gout. Reliable diagnosis can be suggested on the basis of radiological findings alone, even before cutaneous or mucosal lesions appear -which are, at any rate, not sure to appear and typical of nails only. An unquestionable diagnosis can be made at histology of synovial and/or cutaneous nodules. Multicentric reticulohistiocytosis is considered an uncommon condition (nearly 100 cases in international literature to 1989); the authors believe it to be commoner though often misdiagnosed as a 'variant of rehumatoid arthritis'

  12. Placement of the Left Side AED Pad is Poor: Training on the Left Compared to the Right Side of a Manikin Does Not Improve Pad Placement

    DEFF Research Database (Denmark)

    Stærk, Mathilde; Bødtker, Henrik; Rahbek, Søren

    2015-01-01

    participating in a first aid course were randomized to learn automated external defibrillation sitting on the left or right side of a manikin during AED training. After course completion participants operated a training AED (Lifepak® CR-T AED Trainer, PhysioControl) and placed AED pads according to instructions...... volunteers were included and randomized to AED training on the left (n=14, 43% male, age: 47.9 years) and right (n=16, 25% male, age: 46.7 years) side of a manikin. There was no difference in left pad placement when trained on the left or right side (distance to recommended left apical pad position (mean...

  13. A multicentre study to improve clinical interpretation of proteinase-3 and myeloperoxidase anti-neutrophil cytoplasmic antibodies

    DEFF Research Database (Denmark)

    Bossuyt, Xavier; Rasmussen, Niels; van Paassen, Pieter

    2017-01-01

    Objective: The objective of this multicentre study was to improve the clinical interpretation of PR3- and MPO-ANCAs as an adjunct for the diagnosis of ANCA-associated vasculitis (AAV) by defining thresholds and test result intervals based on predefined specificities and by calculating test result...

  14. Disseminating cardiopulmonary resuscitation training by distributing 35,000 personal manikins among school children

    DEFF Research Database (Denmark)

    Isbye, Dan L; Rasmussen, Lars S; Ringsted, Charlotte

    2007-01-01

    BACKGROUND: Because most cardiac arrests occur at home, widespread training is needed to increase the incidence of cardiopulmonary resuscitation (CPR) by lay persons. The aim of this study was to evaluate the effect of mass distribution of CPR instructional materials among schoolchildren. METHODS...... AND RESULTS: We distributed 35,002 resuscitation manikins to pupils (12 to 14 years of age) at 806 primary schools. Using the enclosed 24-minute instructional DVD, they trained in CPR and subsequently used the kit to train family and friends (second tier). They completed a questionnaire on who had trained...... in CPR using the kit. Teachers also were asked to evaluate the project. The incidence of bystander CPR in out-of-hospital cardiac arrest in the months following the project was compared with the previous year. In total, 6947 questionnaires (19.8%) were returned. The 6947 kits had been used to train 17...

  15. A multi-centre dosimetry audit on advanced radiotherapy in lung as part of the Isotoxic IMRT study

    Directory of Open Access Journals (Sweden)

    Yat Tsang

    2017-10-01

    Conclusion: This multi-centre dosimetry audit of complex IMRT/VMAT delivery provides confidence in the accuracy of modern planning and delivery systems in inhomogeneous tissues. The findings from this study can be used as a reference for future dosimetry audits.

  16. Voice advisory manikin versus instructor facilitated training in cardiopulmonary resuscitation

    DEFF Research Database (Denmark)

    Isbye, Dan L; Høiby, Pernilla; Rasmussen, Maria B

    2008-01-01

    BACKGROUND: Training of healthcare staff in cardiopulmonary resuscitation (CPR) is time-consuming and costly. It has been suggested to replace instructor facilitated (IF) training with an automated voice advisory manikin (VAM), which increases skill level by continuous verbal feedback during...... individual training. AIMS: To compare a VAM (ResusciAnne CPR skills station, Laerdal Medical A/S, Norway) with IF training in CPR using a bag-valve-mask (BVM) in terms of skills retention after 3 months. METHODS: Forty-three second year medical students were included and CPR performance (ERC Guidelines...... for Resuscitation 2005) was assessed in a 2 min test before randomisation to either IF training in groups of 8 or individual VAM training. Immediately after training and after 3 months, CPR performance was assessed in identical 2 min tests. Laerdal PC Skill Reporting System 2.0 was used to collect data. To quantify...

  17. Acquisition and retention of basic life support skills in an untrained population using a personal resuscitation manikin and video self-instruction (VSI)

    DEFF Research Database (Denmark)

    Nielsen, Anne Møller; Henriksen, Mikael Johannes Vuokko; Isbye, Dan Lou

    2010-01-01

    Video-based self-instruction (VSI) with a 24-min DVD and a personal resuscitation manikin solves some of the barriers associated with traditional basic life support (BLS) courses. No accurate assessment of the actual improvement in skills after attending a VSI course has been determined...

  18. Mask leak increases and minute ventilation decreases when chest compressions are added to bag ventilation in a neonatal manikin model.

    Science.gov (United States)

    Tracy, Mark B; Shah, Dharmesh; Hinder, Murray; Klimek, Jan; Marceau, James; Wright, Audrey

    2014-05-01

    To determine changes in respiratory mechanics when chest compressions are added to mask ventilation, as recommended by the International Liaison Committee on Resuscitation (ILCOR) guidelines for newborn infants. Using a Laerdal Advanced Life Support leak-free baby manikin and a 240-mL self-inflating bag, 58 neonatal staff members were randomly paired to provide mask ventilation, followed by mask ventilation with chest compressions with a 1:3 ratio, for two minutes each. A Florian respiratory function monitor was used to measure respiratory mechanics, including mask leak. The addition of chest compressions to mask ventilation led to a significant reduction in inflation rate, from 63.9 to 32.9 breaths per minute (p mask leak of 6.8% (p mask ventilation, in accordance with the ILCOR guidelines, in a manikin model is associated with a significant reduction in delivered ventilation and increase in mask leak. If similar findings occur in human infants needing an escalation in resuscitation, there is a potential risk of either delay in recovery or inadequate response to resuscitation. ©2014 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  19. Efficacy of metronome sound guidance via a phone speaker during dispatcher-assisted compression-only cardiopulmonary resuscitation by an untrained layperson: a randomised controlled simulation study using a manikin.

    Science.gov (United States)

    Park, Sang O; Hong, Chong Kun; Shin, Dong Hyuk; Lee, Jun Ho; Hwang, Seong Youn

    2013-08-01

    Untrained laypersons should perform compression-only cardiopulmonary resuscitation (COCPR) under a dispatcher's guidance, but the quality of the chest compressions may be suboptimal. We hypothesised that providing metronome sounds via a phone speaker may improve the quality of chest compressions during dispatcher-assisted COCPR (DA-COCPR). Untrained laypersons were allocated to either the metronome sound-guided group (MG), who performed DA-COCPR with metronome sounds (110 ticks/min), or the control group (CG), who performed conventional DA-COCPR. The participants of each group performed DA-COCPR for 4 min using a manikin with Skill-Reporter, and the data regarding chest compression quality were collected. The data from 33 cases of DA-COCPR in the MG and 34 cases in the CG were compared. The MG showed a faster compression rate than the CG (111.9 vs 96.7/min; p=0.018). A significantly higher proportion of subjects in the MG performed the DA-COCPR with an accurate chest compression rate (100-120/min) compared with the subjects in the CG (32/33 (97.0%) vs 5/34 (14.7%); pMetronome sound guidance during DA-COCPR for the untrained bystanders improved the chest compression rates, but was associated more with shallow compressions than the conventional DA-COCPR in a manikin model.

  20. Neopuff T-piece resuscitator mask ventilation: Does mask leak vary with different peak inspiratory pressures in a manikin model?

    Science.gov (United States)

    Maheshwari, Rajesh; Tracy, Mark; Hinder, Murray; Wright, Audrey

    2017-08-01

    The aim of this study was to compare mask leak with three different peak inspiratory pressure (PIP) settings during T-piece resuscitator (TPR; Neopuff) mask ventilation on a neonatal manikin model. Participants were neonatal unit staff members. They were instructed to provide mask ventilation with a TPR with three PIP settings (20, 30, 40 cm H 2 O) chosen in a random order. Each episode was for 2 min with 2-min rest period. Flow rate and positive end-expiratory pressure (PEEP) were kept constant. Airway pressure, inspiratory and expiratory tidal volumes, mask leak, respiratory rate and inspiratory time were recorded. Repeated measures analysis of variance was used for statistical analysis. A total of 12 749 inflations delivered by 40 participants were analysed. There were no statistically significant differences (P > 0.05) in the mask leak with the three PIP settings. No statistically significant differences were seen in respiratory rate and inspiratory time with the three PIP settings. There was a significant rise in PEEP as the PIP increased. Failure to achieve the desired PIP was observed especially at the higher settings. In a neonatal manikin model, the mask leak does not vary as a function of the PIP when the flow rate is constant. With a fixed rate and inspiratory time, there seems to be a rise in PEEP with increasing PIP. © 2017 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

  1. The Impact of Learning Style on Healthcare Providers' Preference for Voice Advisory Manikins versus Live Instructors in Basic Life Support Training

    Science.gov (United States)

    DiGiovanni, Lisa Marie

    2013-01-01

    The American Heart Association's HeartCode[TM] Healthcare Provider (HCP) Basic Life Support (BLS) e-learning program with voice-advisory manikins was implemented in an acute care hospital as the only teaching method offered for BLS certification. On course evaluations, healthcare provider staff commented that the VAM technology for skills practice…

  2. Combined short- and long-axis ultrasound-guided central venous catheterization is superior to conventional techniques: A cross-over randomized controlled manikin trial.

    Directory of Open Access Journals (Sweden)

    Jun Takeshita

    Full Text Available Visualizing the needle tip using the short-axis (SA ultrasound-guided central venous catheterization approach can be challenging. It has been suggested to start the process with the SA approach and then switch to the long-axis (LA; however, to our knowledge, this combination has not been evaluated. We compared the combined short- and long-axis (SLA approach with the SA approach in a manikin study.We performed a prospective randomized controlled cross-over study in an urban emergency department and intensive care unit. Resident physicians in post-graduate years 1-2 performed a simulated ultrasound-guided internal jugular vein puncture using the SA and SLA approaches on manikins. Twenty resident physicians were randomly assigned to two equal groups: (1 one group performed punctures using the SA approach followed by SLA; and (2 the other performed the same procedures in the opposite order. We compared the success rate and procedure duration for the two approaches. Procedural success was defined as insertion of the guide-wire into the vein while visualizing the needle tip at the time of anterior wall puncture, without penetrating the posterior wall.Six resident physicians (30% performed both approaches successfully, while 12 (60% performed the SLA approach, but not the SA, successfully. Those who performed the SA approach successfully also succeeded with the SLA approach. Two resident physicians (10% failed to perform both approaches. The SLA approach had a significantly higher success rate than the SA approach (P < 0.001. The median (interquartile range procedure duration was 59.5 [46.0-88.5] seconds and 45.0 [37.5-84.0] seconds for the SLA and SA approaches, respectively. The difference of the duration between the two procedures was 15.5 [0-28.5] seconds. There was no significant difference in duration between the two approaches (P = 0.12.Using the SLA approach significantly improved the success rate of internal jugular vein puncture performed by

  3. Performance of cardiopulmonary resuscitation during prolonged basic life support in military medical university students: A manikin study

    Science.gov (United States)

    Wang, Juan; Zhuo, Chao-nan; Zhang, Lei; Gong, Yu-shun; Yin, Chang-lin; Li, Yong-qin

    2015-01-01

    BACKGROUND: The quality of chest compressions can be significantly improved after training of rescuers according to the latest national guidelines of China. However, rescuers may be unable to maintain adequate compression or ventilation throughout a response of average emergency medical services because of increased rescuer fatigue. In the present study, we evaluated the performance of cardiopulmonary resuscitation (CPR) in training of military medical university students during a prolonged basic life support (BLS). METHODS: A 3-hour BLS training was given to 120 military medical university students. Six months after the training, 115 students performed single rescuer BLS on a manikin for 8 minutes. The qualities of chest compressions as well as ventilations were assessed. RESULTS: The average compression depth and rate were 53.7±5.3 mm and 135.1±15.7 compressions per minute respectively. The proportion of chest compressions with appropriate depth was 71.7%±28.4%. The average ventilation volume was 847.2±260.4 mL and the proportion of students with adequate ventilation was 63.5%. Compared with male students, significantly lower compression depth (46.7±4.8 vs. 54.6±4.8 mm, PCPR was found to be related to gender, body weight, and body mass index of students in this study. The quality of chest compressions was well maintained in male students during 8 minutes of conventional CPR but declined rapidly in female students after 2 minutes according to the latest national guidelines. Physical fitness and rescuer fatigue did not affect the quality of ventilation. PMID:26401177

  4. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults

    DEFF Research Database (Denmark)

    Klek, Stanislaw; Chambrier, Cecile; Singer, Pierre

    2013-01-01

    The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion...

  5. Hands-Off Time for Endotracheal Intubation during CPR Is Not Altered by the Use of the C-MAC Video-Laryngoscope Compared to Conventional Direct Laryngoscopy. A Randomized Crossover Manikin Study.

    Directory of Open Access Journals (Sweden)

    Philipp Schuerner

    Full Text Available Sufficient ventilation and oxygenation through proper airway management is essential in patients undergoing cardio-pulmonary resuscitation (CPR. Although widely discussed, securing the airway using an endotracheal tube is considered the standard of care. Endotracheal intubation may be challenging and causes prolonged interruption of chest compressions. Videolaryngoscopes have been introduced to better visualize the vocal cords and accelerate intubation, which makes endotracheal intubation much safer and may contribute to intubation success. Therefore, we aimed to compare hands-off time and intubation success of direct laryngoscopy with videolaryngoscopy (C-MAC, Karl Storz, Tuttlingen, Germany in a randomized, cross-over manikin study.Twenty-six anesthesia residents and twelve anesthesia consultants of the University Hospital Zurich were recruited through a voluntary enrolment. All participants performed endotracheal intubation using direct laryngoscopy and C-MAC in a random order during ongoing chest compressions. Participants were strictly advised to stop chest compression only if necessary.The median hands-off time was 1.9 seconds in direct laryngoscopy, compared to 3 seconds in the C-MAC group. In direct laryngoscopy 39 intubation attempts were recorded, resulting in an overall first intubation attempt success rate of 97%, compared to 38 intubation attempts and 100% overall first intubation attempt success rate in the C-MAC group.As a conclusion, the results of our manikin-study demonstrate that video laryngoscopes might not be beneficial compared to conventional, direct laryngoscopy in easily accessible airways under CPR conditions and in experienced hands. The benefits of video laryngoscopes are of course more distinct in overcoming difficult airways, as it converts a potential "blind intubation" into an intubation under visual control.

  6. Hands-Off Time for Endotracheal Intubation during CPR Is Not Altered by the Use of the C-MAC Video-Laryngoscope Compared to Conventional Direct Laryngoscopy. A Randomized Crossover Manikin Study.

    Science.gov (United States)

    Schuerner, Philipp; Grande, Bastian; Piegeler, Tobias; Schlaepfer, Martin; Saager, Leif; Hutcherson, Matthew T; Spahn, Donat R; Ruetzler, Kurt

    2016-01-01

    Sufficient ventilation and oxygenation through proper airway management is essential in patients undergoing cardio-pulmonary resuscitation (CPR). Although widely discussed, securing the airway using an endotracheal tube is considered the standard of care. Endotracheal intubation may be challenging and causes prolonged interruption of chest compressions. Videolaryngoscopes have been introduced to better visualize the vocal cords and accelerate intubation, which makes endotracheal intubation much safer and may contribute to intubation success. Therefore, we aimed to compare hands-off time and intubation success of direct laryngoscopy with videolaryngoscopy (C-MAC, Karl Storz, Tuttlingen, Germany) in a randomized, cross-over manikin study. Twenty-six anesthesia residents and twelve anesthesia consultants of the University Hospital Zurich were recruited through a voluntary enrolment. All participants performed endotracheal intubation using direct laryngoscopy and C-MAC in a random order during ongoing chest compressions. Participants were strictly advised to stop chest compression only if necessary. The median hands-off time was 1.9 seconds in direct laryngoscopy, compared to 3 seconds in the C-MAC group. In direct laryngoscopy 39 intubation attempts were recorded, resulting in an overall first intubation attempt success rate of 97%, compared to 38 intubation attempts and 100% overall first intubation attempt success rate in the C-MAC group. As a conclusion, the results of our manikin-study demonstrate that video laryngoscopes might not be beneficial compared to conventional, direct laryngoscopy in easily accessible airways under CPR conditions and in experienced hands. The benefits of video laryngoscopes are of course more distinct in overcoming difficult airways, as it converts a potential "blind intubation" into an intubation under visual control.

  7. Revisiting the Robustness of PET-Based Textural Features in the Context of Multi-Centric Trials.

    Science.gov (United States)

    Bailly, Clément; Bodet-Milin, Caroline; Couespel, Solène; Necib, Hatem; Kraeber-Bodéré, Françoise; Ansquer, Catherine; Carlier, Thomas

    2016-01-01

    This study aimed to investigate the variability of textural features (TF) as a function of acquisition and reconstruction parameters within the context of multi-centric trials. The robustness of 15 selected TFs were studied as a function of the number of iterations, the post-filtering level, input data noise, the reconstruction algorithm and the matrix size. A combination of several reconstruction and acquisition settings was devised to mimic multi-centric conditions. We retrospectively studied data from 26 patients enrolled in a diagnostic study that aimed to evaluate the performance of PET/CT 68Ga-DOTANOC in gastro-entero-pancreatic neuroendocrine tumors. Forty-one tumors were extracted and served as the database. The coefficient of variation (COV) or the absolute deviation (for the noise study) was derived and compared statistically with SUVmax and SUVmean results. The majority of investigated TFs can be used in a multi-centric context when each parameter is considered individually. The impact of voxel size and noise in the input data were predominant as only 4 TFs presented a high/intermediate robustness against SUV-based metrics (Entropy, Homogeneity, RP and ZP). When combining several reconstruction settings to mimic multi-centric conditions, most of the investigated TFs were robust enough against SUVmax except Correlation, Contrast, LGRE, LGZE and LZLGE. Considering previously published results on either reproducibility or sensitivity against delineation approach and our findings, it is feasible to consider Homogeneity, Entropy, Dissimilarity, HGRE, HGZE and ZP as relevant for being used in multi-centric trials.

  8. MANAGEMENT AND OUTCOMES FROM APPENDECTOMY: AN INTERNATIONAL, PROSPECTIVE, MULTICENTRE STUDY.

    Science.gov (United States)

    Camilleri-Brennan, J; Drake, T; Spence, R; Bhangu, A; Harrison, E

    2017-09-01

    To identify variation in surgical management and outcomes of appendicitis across low, middle and high Human Development Index (HDI) country groups. Multi-centre, international prospective cohort study of consecutive patients undergoing emergency appendectomy over a 6-month period. Follow-up lasted 30 days. Primary outcome measure was overall complication rate. 4546 patients from 52 countries underwent appendectomy (2499 high, 1540 middle and 507 low HDI groups). Complications were more frequent in low-HDI (OR 3.81, 95% CI 2.78 to 5.19, p accounting for case-mix, laparoscopy was still associated with fewer complications (OR 0.55, 95% CI 0.42 to 0.71, pintroduction of laparoscopy that if overcome, could result in significantly improved outcomes for patients in low-resource environments, with potential for wider health-system benefits.

  9. Evaluation of a novel noninvasive continuous core temperature measurement system with a zero heat flux sensor using a manikin of the human body.

    Science.gov (United States)

    Brandes, Ivo F; Perl, Thorsten; Bauer, Martin; Bräuer, Anselm

    2015-02-01

    Reliable continuous perioperative core temperature measurement is of major importance. The pulmonary artery catheter is currently the gold standard for measuring core temperature but is invasive and expensive. Using a manikin, we evaluated the new, noninvasive SpotOn™ temperature monitoring system (SOT). With a sensor placed on the lateral forehead, SOT uses zero heat flux technology to noninvasively measure core temperature; and because the forehead is devoid of thermoregulatory arteriovenous shunts, a piece of bone cement served as a model of the frontal bone in this study. Bias, limits of agreements, long-term measurement stability, and the lowest measurable temperature of the device were investigated. Bias and limits of agreement of the temperature data of two SOTs and of the thermistor placed on the manikin's surface were calculated. Measurements obtained from SOTs were similar to thermistor values. The bias and limits of agreement lay within a predefined clinically acceptable range. Repeat measurements differed only slightly, and stayed stable for hours. Because of its temperature range, the SOT cannot be used to monitor temperatures below 28°C. In conclusion, the new SOT could provide a reliable, less invasive and cheaper alternative for measuring perioperative core temperature in routine clinical practice. Further clinical trials are needed to evaluate these results.

  10. Harmonization process and reliability assessment of anthropometric measurements in the elderly EXERNET multi-centre study.

    Directory of Open Access Journals (Sweden)

    Alba Gómez-Cabello

    Full Text Available BACKGROUND: The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. PURPOSE: To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. MATERIALS AND METHODS: A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. RESULTS: For height, intra-rater technical errors of measurement (TEMs were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. CONCLUSION: The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population.

  11. Revisiting the Robustness of PET-Based Textural Features in the Context of Multi-Centric Trials.

    Directory of Open Access Journals (Sweden)

    Clément Bailly

    Full Text Available This study aimed to investigate the variability of textural features (TF as a function of acquisition and reconstruction parameters within the context of multi-centric trials.The robustness of 15 selected TFs were studied as a function of the number of iterations, the post-filtering level, input data noise, the reconstruction algorithm and the matrix size. A combination of several reconstruction and acquisition settings was devised to mimic multi-centric conditions. We retrospectively studied data from 26 patients enrolled in a diagnostic study that aimed to evaluate the performance of PET/CT 68Ga-DOTANOC in gastro-entero-pancreatic neuroendocrine tumors. Forty-one tumors were extracted and served as the database. The coefficient of variation (COV or the absolute deviation (for the noise study was derived and compared statistically with SUVmax and SUVmean results.The majority of investigated TFs can be used in a multi-centric context when each parameter is considered individually. The impact of voxel size and noise in the input data were predominant as only 4 TFs presented a high/intermediate robustness against SUV-based metrics (Entropy, Homogeneity, RP and ZP. When combining several reconstruction settings to mimic multi-centric conditions, most of the investigated TFs were robust enough against SUVmax except Correlation, Contrast, LGRE, LGZE and LZLGE.Considering previously published results on either reproducibility or sensitivity against delineation approach and our findings, it is feasible to consider Homogeneity, Entropy, Dissimilarity, HGRE, HGZE and ZP as relevant for being used in multi-centric trials.

  12. ZOOM or Non-ZOOM? Assessing Spinal Cord Diffusion Tensor Imaging Protocols for Multi-Centre Studies.

    Directory of Open Access Journals (Sweden)

    Rebecca S Samson

    Full Text Available The purpose of this study was to develop and evaluate two spinal cord (SC diffusion tensor imaging (DTI protocols, implemented at multiple sites (using scanners from two different manufacturers, one available on any clinical scanner, and one using more advanced options currently available in the research setting, and to use an automated processing method for unbiased quantification. DTI parameters are sensitive to changes in the diseased SC. However, imaging the cord can be technically challenging due to various factors including its small size, patient-related and physiological motion, and field inhomogeneities. Rapid acquisition sequences such as Echo Planar Imaging (EPI are desirable but may suffer from image distortions. We present a multi-centre comparison of two acquisition protocols implemented on scanners from two different vendors (Siemens and Philips, one using a reduced field-of-view (rFOV EPI sequence, and one only using options available on standard clinical scanners such as outer volume suppression (OVS. Automatic analysis was performed with the Spinal Cord Toolbox for unbiased and reproducible quantification of DTI metrics in the white matter. Images acquired using the rFOV sequence appear less distorted than those acquired using OVS alone. SC DTI parameter values obtained using both sequences at all sites were consistent with previous measurements made at 3T. For the same scanner manufacturer, DTI parameter inter-site SDs were smaller for the rFOV sequence compared to the OVS sequence. The higher inter-site reproducibility (for the same manufacturer and acquisition details, i.e. ZOOM data acquired at the two Philips sites of rFOV compared to the OVS sequence supports the idea that making research options such as rFOV more widely available would improve accuracy of measurements obtained in multi-centre clinical trials. Future multi-centre studies should also aim to match the rFOV technique and signal-to-noise ratios in all

  13. Prophylactic efficacy of lithium administered every second day: a WHO multicentre study

    DEFF Research Database (Denmark)

    Plenge, P; Amin, M; Agarwal, A K

    1999-01-01

    OBJECTIVES: To study the prophylactic efficacy of lithium administered every second day to patients with bipolar disorder or recurrent unipolar depressive disorder. METHODS: The study was carried out as a WHO multicentre study in five different psychiatric clinics: Russia (Moscow), Canada (Montreal......), India (Lucknow), Germany (Munich) and South Korea (Pusan), with the lithium tablets being supplied from Denmark (Copenhagen). Participation in the study was conditional on the patient having been in prophylactic lithium treatment for the preceding 2-year period and having been free of depressive...... of bipolar disorder and five with a diagnosis of recurrent unipolar depressive disorder, participated in the study. The number of patients from each centre ranged from six to 11. The mean lithium dose every second day was 36 mmol lithium, leading to a mean 12-h standard serum lithium concentration during...

  14. Evaluation of the preliminary auditory profile test battery in an international multi-centre study

    NARCIS (Netherlands)

    van Esch, T.E.M.; Kollmeier, B.; Vormann, M.; Lijzenga, J.; Houtgast, T.; Hallgren, M.; Larsby, B.; Athalye, S.P.; Lutman, M.E.; Dreschler, W.A.

    2013-01-01

    Objective: This paper describes the composition and international multi-centre evaluation of a battery of tests termed the preliminary auditory profile. It includes measures of loudness perception, listening effort, speech perception, spectral and temporal resolution, spatial hearing, self-reported

  15. Primary adrenal insufficiency in adult population: a Portuguese Multicentre Study by the Adrenal Tumours Study Group.

    Science.gov (United States)

    Ferreira, Lia; Silva, João; Garrido, Susana; Bello, Carlos; Oliveira, Diana; Simões, Hélder; Paiva, Isabel; Guimarães, Joana; Ferreira, Marta; Pereira, Teresa; Bettencourt-Silva, Rita; Martins, Ana Filipa; Silva, Tiago; Fernandes, Vera; Pereira, Maria Lopes

    2017-11-01

    Primary adrenal insufficiency (PAI) is a rare but severe and potentially life-threatening condition. No previous studies have characterized Portuguese patients with PAI. To characterize the clinical presentation, diagnostic workup, treatment and follow-up of Portuguese patients with confirmed PAI. This multicentre retrospective study examined PAI patients in 12 Portuguese hospitals. We investigated 278 patients with PAI (55.8% were females), with a mean age of 33.6 ± 19.3 years at diagnosis. The most frequent presenting clinical features were asthenia (60.1%), mucocutaneous hyperpigmentation (55.0%) and weight loss (43.2%); 29.1% of the patients presented with adrenal crisis. Diagnosis was established by high plasma ACTH and low serum cortisol in most patients (43.9%). The most common aetiology of PAI was autoimmune adrenalitis (61.0%). There were 38 idiopathic cases. Autoimmune comorbidities were found in 70% of the patients, the most frequent being autoimmune thyroiditis (60.7%) and type 1 diabetes mellitus (17.3%). Seventy-nine percent were treated with hydrocortisone (mean dose 26.3 ± 8.3 mg/day) mostly in three (57.5%) or two (37.4%) daily doses. The remaining patients were treated with prednisolone (10.1%), dexamethasone (6.2%) and methylprednisolone (0.7%); 66.2% were also on fludrocortisone (median dose of 100 µg/day). Since diagnosis, 33.5% of patients were hospitalized for disease decompensation. In the last appointment, 17.2% of patients had complaints (7.6% asthenia and 6.5% depression) and 9.7% had electrolyte disturbances. This is the first multicentre Portuguese study regarding PAI. The results emphasize the need for standardization in diagnostic tests and etiological investigation and provide a framework for improving treatment. © 2017 The authors.

  16. Italian multicentre study on intrathecal fluorescein for craniosinusal fistulae.

    Science.gov (United States)

    Felisati, G; Bianchi, A; Lozza, P; Portaleone, S

    2008-08-01

    derives from frequent reports of complications, often related to the intrathecal administration; such complications are, however, always due to an incorrect dosage. In order to perform correct monitoring of any complication related to the use of intrathecal fluorescein and to investigate in a strictly scientific fashion, the legal problem related to the off label use (intrathecal administration) of an authorised substance, the Authors coordinated an Italian multicentre study aimed at establishig the tolerability of the lumbar intrathecal administration of fluorescein. Aim of the study was to review the literature focusing on CSF leaks, to set up to date diagnostic and therapeutic indications of fluorescein and to report the preliminary results of the Italian multicentre study.

  17. Building a Multi-centre Clinical Research Facilitation Network: The ARC Experience

    Directory of Open Access Journals (Sweden)

    Ian Nicholson

    2017-06-01

    Full Text Available Introduction: In order to practice evidence-based veterinary medicine, good quality clinical evidence needs to be produced, in order that it can be apprasied systematically by the EBVM network, and used by vets. There is very little good-quality veterinary evidence for most of the veterinary procedures carried out every day across the world. Very few, if any, individuals have all the necessary qualities (case-load, time, research expertise, financial support to be able to systematically produce good-quality, and relevant, clinical research on their own, in a timely manner. The Association for Veterinary Soft Tissue Surgery (AVSTS www.avsts.org.uk is an affiliate group with the British Small Animal Veterinary Association (BSAVA, and functions as a clinical network of like-minded individuals. In 2013 AVSTS sought to create a role for itself in facilitating the production (by its members of multi-centre clinical research of relevance to its members.Materials and methods: Members of AVSTS were asked to join the AVSTS Research Cooperative (ARC, with a veterinary epidemiologist and an experienced multi-centre veterinary clinical researcher (to help with study design and statistical planning, and the Animal Health Trust clinical research ethics committee. An email list was established, and a page was set up on the AVSTS website, to allow information to be disseminated. The AVSTS spring and autumn meetings were used as a regular forum by ARC, to discuss its direction, to generate interest, to create and promote specific studies (in order to widen participation amongst different centres, and to update members about previous studies.Results: Membership of ARC has grown to 224 people, although the epidemiologist left. One multi-centre study has been published, two have been presented and await publication, one has been accepted for presentation, two other studies are gathering data at present, and further studies are in the pipeline. There has been

  18. Image acquisition and interpretation criteria for Tc-99m-HMPAO-labelled white blood cell scintigraphy : results of a multicentre study

    NARCIS (Netherlands)

    Erba, Paola A.; Glaudemans, Andor W. J. M.; Veltman, Niels C.; Sollini, Martina; Pacilio, Marta; Galli, Filippo; Dierckx, Rudi A. J. O.; Signore, Alberto

    Purpose There is no consensus yet on the best protocol for planar image acquisition and interpretation of radiolabelled white blood cell (WBC) scintigraphy. This may account for differences in reported diagnostic accuracy amongst different centres. Methods This was a multicentre retrospective study

  19. Performance of cardiopulmonary resuscitation during prolonged basic life support in military medical university students: A manikin study.

    Science.gov (United States)

    Wang, Juan; Zhuo, Chao-Nan; Zhang, Lei; Gong, Yu-Shun; Yin, Chang-Lin; Li, Yong-Qin

    2015-01-01

    The quality of chest compressions can be significantly improved after training of rescuers according to the latest national guidelines of China. However, rescuers may be unable to maintain adequate compression or ventilation throughout a response of average emergency medical services because of increased rescuer fatigue. In the present study, we evaluated the performance of cardiopulmonary resuscitation (CPR) in training of military medical university students during a prolonged basic life support (BLS). A 3-hour BLS training was given to 120 military medical university students. Six months after the training, 115 students performed single rescuer BLS on a manikin for 8 minutes. The qualities of chest compressions as well as ventilations were assessed. The average compression depth and rate were 53.7±5.3 mm and 135.1±15.7 compressions per minute respectively. The proportion of chest compressions with appropriate depth was 71.7%±28.4%. The average ventilation volume was 847.2±260.4 mL and the proportion of students with adequate ventilation was 63.5%. Compared with male students, significantly lower compression depth (46.7±4.8 vs. 54.6±4.8 mm, P<0.001) and adequate compression rate (35.5%±26.5% vs. 76.1%±25.1%, P<0.001) were observed in female students. CPR was found to be related to gender, body weight, and body mass index of students in this study. The quality of chest compressions was well maintained in male students during 8 minutes of conventional CPR but declined rapidly in female students after 2 minutes according to the latest national guidelines. Physical fitness and rescuer fatigue did not affect the quality of ventilation.

  20. A Japanese cross-sectional multicentre study of biomarkers associated with cardiovascular disease in smokers and non-smokers

    OpenAIRE

    L?dicke, Frank; Magnette, John; Baker, Gizelle; Weitkunat, Rolf

    2015-01-01

    Abstract We performed a cross-sectional, multicentre study in Japan to detect the differences in biomarkers of exposure and cardiovascular biomarkers between smokers and non-smokers. Several clinically relevant cardiovascular biomarkers differed significantly between smokers and non-smokers, including lipid metabolism (high-density lipoprotein cholesterol concentrations ? lower in smokers), inflammation (fibrinogen and white blood cell count ? both higher in smokers), oxidative stress (8-epi-...

  1. Treatment of unicentric and multicentric Castleman disease and the role of radiotherapy.

    Science.gov (United States)

    Chronowski, G M; Ha, C S; Wilder, R B; Cabanillas, F; Manning, J; Cox, J D

    2001-08-01

    Although surgery is considered standard therapy for unicentric Castleman disease, favorable responses to radiotherapy also have been documented. The authors undertook this study to analyze the clinical factors, treatment approaches, and outcomes of patients with unicentric or multicentric Castleman disease, and to report the outcomes of patients with unicentric Castleman disease treated with radiotherapy. The authors reviewed the medical records of 22 patients who had received a histologic diagnosis of Castleman disease at the University of Texas M. D. Anderson Cancer Center between 1988 and 1999. One patient with a concurrent histopathologic diagnosis of nonsecretory multiple myeloma was excluded from the study. In all patients, the diagnosis of Castleman disease was based on the results of lymph node biopsies. Disease was categorized as being either unicentric or multicentric and further subdivided into hyaline vascular, plasma cell, or mixed variant histologic types. Clinical variables and outcomes were analyzed according to treatment, which consisted of surgery, chemotherapy, or radiotherapy. Records from 21 patients were analyzed: 12 had unicentric disease, and 9 had multicentric disease. The mean follow-up time for the entire series was 51 months (median, 40 months). Four patients with unicentric disease were treated with radiotherapy alone: 2 remain alive and symptom free, 2 died of causes unrelated to Castleman disease and had no evidence of disease at last follow-up. Eight patients with unicentric disease were treated with complete or partial surgical resection, and all are alive and asymptomatic. All nine patients with multicentric disease were treated with combination chemotherapy: five are alive with no evidence of disease, and four are alive with progressive disease. Surgery results in excellent rates of cure in patients with unicentric Castleman disease; radiotherapy can also achieve clinical response and cure in selected patients. Multicentric

  2. Questing for circadian dependence in ST-segment-elevation acute myocardial infarction: A multicentric and multiethnic study

    KAUST Repository

    Ammirati, Enrico

    2013-05-09

    Rationale: Four monocentric studies reported that circadian rhythms can affect left ventricular infarct size after ST-segment-elevation acute myocardial infarction (STEMI). Objective: To further validate the circadian dependence of infarct size after STEMI in a multicentric and multiethnic population. Methods and Results: We analyzed a prospective cohort of subjects with first STEMI from the First Acute Myocardial Infarction study that enrolled 1099 patients (ischemic time <6 hours) in Italy, Scotland, and China. We confirmed a circadian variation of STEMI incidence with an increased morning incidence (from 6:00 am till noon). We investigated the presence of circadian dependence of infarct size plotting the peak creatine kinase against time onset of ischemia. In addition, we studied the patients from the 3 countries separately, including 624 Italians; all patients were treated with percutaneous coronary intervention. We adopted several levels of analysis with different inclusion criteria consistent with previous studies. In all the analyses, we did not find a clear-cut circadian dependence of infarct size after STEMI. Conclusions: Although the circadian dependence of infarct size supported by previous studies poses an intriguing hypothesis, we were unable to converge toward their conclusions in a multicentric and multiethnic setting. Parameters that vary as a function of latitude could potentially obscure the circadian variations observed in monocentric studies. We believe that, to assess whether circadian rhythms can affect the infarct size, future study design should not only include larger samples but also aim to untangle the molecular time-dynamic mechanisms underlying such a relation. © 2013 American Heart Association, Inc.

  3. Improving the well-being of elderly patients via community pharmacy-based provision of pharmaceutical care - A multicentre study in seven European countries

    NARCIS (Netherlands)

    Bernsten, C; Bjorkman, [No Value; Caramona, M; Crealey, G; Frokjaer, B; Grundberger, E; Gustafsson, T; Henman, M; Herborg, H; Hughes, C; McElnay, J; Magner, M; van Mil, F; Schaeffer, M; Silva, S; Sondergaard, B; Sturgess, [No Value; Tromp, D; Vivero, L; Winterstein, A

    2001-01-01

    Objective: This study aimed to measure the outcomes of a harmonised, structured pharmaceutical care programme provided to elderly patients: (greater than or equal to 65 years of age) by community pharmacists in a multicentre international study performed in 7 European countries. Design and setting:

  4. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study.

    LENUS (Irish Health Repository)

    Maharaj, C H

    2006-05-01

    The Airtraq Laryngoscope is a novel intubation device which allows visualisation of the vocal cords without alignment of the oral, pharyngeal and tracheal axes. We compared the Airtraq with the Macintosh laryngoscope in simulated easy and difficult laryngoscopy. Twenty-five anaesthetists were allowed up to three attempts to intubate the trachea in each of three laryngoscopy scenarios using a Laerdal Intubation Trainer followed by five scenarios using a Laerdal SimMan Manikin. Each anaesthetist then performed tracheal intubation of the normal airway a second time to characterise the learning curve. In the simulated easy laryngoscopy scenarios, there was no difference between the Airtraq and the Macintosh in success of tracheal intubation. The time taken to intubate at the end of the protocol was significantly lower using the Airtraq (9.5 (6.7) vs. 14.2 (7.4) s), demonstrating a rapid acquisition of skills. In the simulated difficult laryngoscopy scenarios, the Airtraq was more successful in achieving tracheal intubation, required less time to intubate successfully, caused less dental trauma, and was considered by the anaesthetists to be easier to use.

  5. Data collection using open access technology in multicentre operational research involving patient interviews.

    Science.gov (United States)

    Shewade, H D; Chadha, S S; Gupta, V; Tripathy, J P; Satyanarayana, S; Sagili, K; Mohanty, S; Bera, O P; Pandey, P; Rajeswaran, P; Jayaraman, G; Santhappan, A; Bajpai, U N; Mamatha, A M; Maiser, R; Naqvi, A J; Pandurangan, S; Nath, S; Ghule, V H; Das, A; Prasad, B M; Biswas, M; Singh, G; Mallick, G; Jeyakumar Jaisingh, A J; Rao, R; Kumar, A M V

    2017-03-21

    Conducting multicentre operational research is challenging due to issues related to the logistics of travel, training, supervision, monitoring and troubleshooting support. This is even more burdensome in resource-constrained settings and if the research includes patient interviews. In this article, we describe an innovative model that uses open access tools such as Dropbox, TeamViewer and CamScanner for efficient, quality-assured data collection in an ongoing multicentre operational research study involving record review and patient interviews. The tools used for data collection have been shared for adaptation and use by other researchers.

  6. Multicentric Giant Cell Tumor of Bone: Synchronous and Metachronous Presentation

    Directory of Open Access Journals (Sweden)

    Reiner Wirbel

    2013-01-01

    Full Text Available A 27-year-old man treated 2.5 years ago for synchronous multicentric giant cell tumor of bone located at the right proximal humerus and the right 5th finger presented now with complaints of pain in his right hip and wrist of two-month duration. Radiology and magnetic resonance revealed multicentric giant cell tumor lesions of the right proximal femur, the left ileum, the right distal radius, and the left distal tibia. The patient has an eighteen-year history of a healed osteosarcoma of the right tibia that was treated with chemotherapy, resection, and allograft reconstruction. A literature review establishes this as the first reported case of a patient with synchronous and metachronous multicentric giant cell tumor who also has a history of osteosarcoma.

  7. Fiscal 1997 report on the results of the international standardization R and D. International standards for computers/manikins; 1997 nendo seika hokokusho kokusai hyojun soseigata kenkyu kaihatsu. Computer manikin ni kansuru kokusai hyojun kikaku

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-03-01

    Through the development of computer manikins (CM) which assess human adaptability to products and environments, a draft for international standardization was worked out to propose to ISO. A draft for the international standardization was presented to ISO through a development of `a structure model` changing based on human attributes, a study of `a motion model` enabling changes in posture and movement, a study of `an evaluation model` evaluating attainment ranges and ecodynamic loads, and a development of `computer functions` realizing the above-mentioned functions. The development of CM having the following characteristics: a function to reproduce `the structure model` based on the ISO7250 human body dimensional measuring values which were regulated in items for the human body dimensional measuring, a function to change posture/movement based on the joint movable range data, a function to evaluate geometrical human adaptability such as attainment ranges. As a plug-in to Autodesk Mechanical Desktop 2.0, the above-mentioned functions were realized, and the modular structure platform was constructed which enables the wide-range cross-industry option and functional expansion by the advance of CM. 7 refs., 41 figs., 18 tabs.

  8. Segmental equivalent temperature determined by means of a thermal manikin: A method for correcting errors due to incomplete contact of the body with a surface

    DEFF Research Database (Denmark)

    Melikov, Arsen Krikor; Janieas, N.R.D.J.; Silva, M.C.G.

    2004-01-01

    of the thermal manikins used at present is not as flexible as the human body and is divided into body segments with a surface area that differs from that of the human body in contact with a surface. The area of the segment in contact with a surface will depend on the shape and flexibility of the surface...

  9. Retrospective exposure assessment and quality control in an international multi-centre case-control study

    DEFF Research Database (Denmark)

    Tinnerberg, H; Heikkilä, P; Huici-Montagud, A

    2003-01-01

    The paper presents the exposure assessment method and quality control procedure used in an international, multi-centre case-control study within a joint Nordic and Italian cohort. This study was conducted to evaluate whether occupational exposure to carcinogens influenced the predictivity of high...... was higher among the original assessors (the assessor from the same country as the subject) than the average prevalence assessed by the other four in the quality control round. The original assessors classified more job situations as exposed than the others. Several reasons for this are plausible: real...... country-specific differences, differences in information available to the home assessor and the others and misunderstandings or difficulties in translation of information. To ensure the consistency of exposure assessments in international retrospective case-control studies it is important to have a well...

  10. Species distribution and susceptibility profile to fluconazole, voriconazole and MXP-4509 of 551 clinical yeast isolates from a Romanian multi-centre study

    NARCIS (Netherlands)

    Minea, B; Nastasa, V; Moraru, R F; Kolecka, A; Flonta, M M; Marincu, I; Man, A; Toma, F; Lupse, M; Doroftei, B; Marangoci, N; Pinteala, M; Boekhout, T; Mares, M

    This is the first multi-centre study regarding yeast infections in Romania. The aim was to determine the aetiological spectrum and susceptibility pattern to fluconazole, voriconazole and the novel compound MXP-4509. The 551 isolates were identified using routine laboratory methods, matrix-assisted

  11. Unilateral pallidotomy in Parkinson's disease : a randomised, single-blind, multicentre trial

    NARCIS (Netherlands)

    de Bie, RMA; de Haan, RJ; Nijssen, PCG; Rutgers, AWF; Beute, GN; Haaxma, R; Schmand, B; Staal, MJ; Speelman, J.D.

    1999-01-01

    Background The results of several cohort studies suggest that patients with advanced Parkinson's disease would benefit from unilateral pallidotomy. We have assessed the efficacy of unilateral pallidotomy in a randomised, single-blind, multicentre trial. Methods We enrolled 37 patients with advanced

  12. Upper limb muscular activity and perceived workload during laryngoscopy: comparison of Glidescope(R) and Macintosh laryngoscopy in manikin: an observational study.

    Science.gov (United States)

    Caldiroli, D; Molteni, F; Sommariva, A; Frittoli, S; Guanziroli, E; Cortellazzi, P; Orena, E F

    2014-03-01

    The interaction between operators and their working environment during laryngoscopy is poorly understood. Numerous studies have focused on the forces applied to the patient's airway during laryngoscopy, but only a few authors have addressed operator muscle activity and workload. We tested whether different devices (Glidescope(®) and Macintosh) use different muscles and how these differences affect the perceived workload. Ten staff anaesthetists performed three intubations with each device on a manikin. Surface electromyography was recorded for eight single muscles of the left upper limb. The NASA Task Load Index (TLX) was administered after each experimental session to evaluate perceived workload. A consistent reduction in muscular activation occurred with Glidescope(®) compared with Macintosh for all muscles tested (mean effect size d=3.28), and significant differences for the upper trapezius (P=0.002), anterior deltoid (P=0.001), posterior deltoid (P=0.000), and brachioradialis (P=0.001) were observed. The overall NASA-TLX workload score was significantly lower for Glidescope(®) than for Macintosh (P=0.006), and the factors of physical demand (P=0.008) and effort (P=0.006) decreased significantly. Greater muscular activity and workload were observed with the Macintosh laryngoscope. Augmented vision and related postural adjustments related to using the Glidescope(®) may reduce activation of the operator's muscles and task workload.

  13. The effectiveness of 2-implant overdentures - a pragmatic international multicentre study.

    LENUS (Irish Health Repository)

    Rashid, F

    2011-03-01

    The purpose of this multicentre observational study was to determine patient satisfaction with either conventional dentures or mandibular 2-implant overdentures in a \\'real world\\' setting. Two hundred and three edentulous patients (mean age 68·8 ± 10·4 years) were recruited at eight centres located in North America, South America and Europe. The patients were provided with new mandibular conventional dentures or implant overdentures supported by two implants and ball attachments. At baseline and at 6 months post-treatment, they rated their satisfaction with their mandibular prostheses on 100-mm visual analogue scale questionnaires. One hundred and two (50·2%) participants had valid baseline and 6-month satisfaction data. Although both groups reported improvements, the implant overdenture group reported significantly higher ratings of overall satisfaction, comfort, stability, ability to speak and ability to chew. These results suggest that edentulous patients who choose mandibular implant overdentures have significantly greater improvements in satisfaction, despite their relatively higher cost, than those who choose new conventional dentures.

  14. Cerebral sinus venous thromboses in children with acute lymphoblastic leukaemia - a multicentre study from the Nordic Society of Paediatric Haematology and Oncology

    DEFF Research Database (Denmark)

    Ranta, Susanna; Tuckuviene, Ruta; Mäkipernaa, Anne

    2014-01-01

    We present a prospective multicentre cohort of 20 children with acute lymphoblastic leukaemia (ALL) and cerebral sinus venous thrombosis (CSVT). The study covers a period of 5 years and comprises 1038 children treated according to the Nordic Society of Paediatric Haematology and Oncology (NOPHO...

  15. Coronary CT angiography using 64 detector rows: methods and design of the multi-centre trial CORE-64

    Energy Technology Data Exchange (ETDEWEB)

    Miller, Julie M.; Vavere, Andrea L.; Arbab-Zadeh, Armin; Bush, David E.; Lardo, Albert C.; Texter, John; Brinker, Jeffery; Lima, Joao A.C. [Johns Hopkins Hospital, Johns Hopkins University, Department of Medicine, Division of Cardiology, Baltimore, MD (United States); Dewey, Marc [Charite - Universitaetsmedizin Berlin, Medical School, Humboldt-Universitaet und Freie Universitaet zu Berlin, Department of Radiology, Berlin, PO Box 10098 (Germany); Rochitte, Carlos E.; Lemos, Pedro A. [University of Sao Paulo Medical School, Heart Institute (InCor), Sao Paulo (Brazil); Niinuma, Hiroyuki [Iwate Medical University, Department of Cardiology, Morioka (Japan); Paul, Narinder [Toronto General Hospital, Department of Medical Imaging, Toronto (Canada); Hoe, John [Medi-Rad Associates Ltd, CT Centre, Mt Elizabeth Hospital, Singapore (Singapore); Roos, Albert de [Leiden University Medical Center, Department of Radiology, Leiden (Netherlands); Yoshioka, Kunihiro [Iwate Medical University, Department of Radiology, Morioka (Japan); Cox, Christopher [Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, MD (United States); Clouse, Melvin E. [Harvard University, Department of Radiology, Beth Israel Deaconess, Boston, MA (United States)

    2009-04-15

    Multislice computed tomography (MSCT) for the noninvasive detection of coronary artery stenoses is a promising candidate for widespread clinical application because of its non-invasive nature and high sensitivity and negative predictive value as found in several previous studies using 16 to 64 simultaneous detector rows. A multi-centre study of CT coronary angiography using 16 simultaneous detector rows has shown that 16-slice CT is limited by a high number of nondiagnostic cases and a high false-positive rate. A recent meta-analysis indicated a significant interaction between the size of the study sample and the diagnostic odds ratios suggestive of small study bias, highlighting the importance of evaluating MSCT using 64 simultaneous detector rows in a multi-centre approach with a larger sample size. In this manuscript we detail the objectives and methods of the prospective ''CORE-64'' trial (''Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography using 64 Detectors''). This multi-centre trial was unique in that it assessed the diagnostic performance of 64-slice CT coronary angiography in nine centres worldwide in comparison to conventional coronary angiography. In conclusion, the multi-centre, multi-institutional and multi-continental trial CORE-64 has great potential to ultimately assess the per-patient diagnostic performance of coronary CT angiography using 64 simultaneous detector rows. (orig.)

  16. The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study

    DEFF Research Database (Denmark)

    Gerhardsen, G.; Hansen, A.V.; Killi, M.

    2008-01-01

    Introduction: A double-blind, placebo-controlled, randomised, parallel-group, multicentre study was conducted to evaluate the effect of a pollen-based herbal medicinal product, Femal (R) (Sea-Band Ltd, Leicestershire, UK), on premenstrual sleep disturbances (PSD) in women with premenstrual syndrome...... as the main symptom cluster makes this herbal medicinal product a promising addition to the therapeutic arsenal for women with PMS Udgivelsesdato: 2008/6...

  17. Salmeterol versus slow-release theophylline combined with ketotifen in nocturnal asthma: a multicentre trial. French Multicentre Study Group.

    Science.gov (United States)

    Muir, J F; Bertin, L; Georges, D

    1992-11-01

    We wished to assess the efficacy of inhaled salmeterol (SML; 50 micrograms b.i.d.) compared to a combination of slow-release theophylline and ketotifen p.o. (TK; T 300 mg+K 1 mg b.i.d.) for the treatment of nocturnal asthma. Ninety six patients with nocturnal asthma, (forced expiratory volume in one second (FEV1) 60-90% of predicted value, reversibility > or = 15%, at least two nocturnal awakenings per week) were eligible for a multicentre, double-blind, double-dummy cross-over study (14-day run-in, two successive 28-day treatment periods). Efficacy was assessed as success/failure, success being defined as the complete disappearance of nocturnal symptoms/awakening during the last week of each treatment period. There was a statistically significant difference between SML and TK for this criterion: 46% and 39% success with SML during periods I (first 28-day period) and II (following the cross-over), compared to only 15% and 26% with TK, respectively (p < 0.01). SML was also significantly better for the other criteria (lung function, rescue salbutamol intake during day and night). Side-effects were five times less frequent in SML-treated patients (p < 0.004). Efficacy and tolerance of SML were obviously far better than those of TK in patients with nocturnal asthma.

  18. Effects of combined exercise training and electromyostimulation treatments in chronic heart failure: A prospective multicentre study.

    Science.gov (United States)

    Iliou, Marie C; Vergès-Patois, Bénédicte; Pavy, Bruno; Charles-Nelson, Anais; Monpère, Catherine; Richard, Rudy; Verdier, Jean C

    2017-08-01

    Background Exercise training as part of a comprehensive cardiac rehabilitation is recommended for patients with cardiac heart failure. It is a valuable method for the improvement of exercise tolerance. Some studies reported a similar improvement with quadricipital electrical myostimulation, but the effect of combined exercise training and electrical myostimulation in cardiac heart failure has not been yet evaluated in a large prospective multicentre study. Purpose The aim of this study was to determine whether the addition of low frequency electrical myostimulation to exercise training may improve exercise capacity and/or muscular strength in cardiac heart failure patients. Methods Ninety-one patients were included (mean age: 58 ± 9 years; New York Heart Association II/III: 52/48%, left ventricular ejection fraction: 30 ± 7%) in a prospective French study. The patients were randomised into two groups: 41 patients in exercise training and 50 in exercise training + electrical myostimulation. All patients underwent 20 exercise training sessions. In addition, in the exercise training + electrical myostimulation group, patients underwent 20 low frequency (10 Hz) quadricipital electrical myostimulation sessions. Each patient underwent a cardiopulmonary exercise test, a six-minute walk test, a muscular function evaluation and a quality of life questionnaire, before and at the end of the study. Results A significant improvement of exercise capacity (Δ peak oxygen uptake+15% in exercise training group and +14% in exercise training + electrical myostimulation group) and of quality of life was observed in both groups without statistically significant differences between the two groups. Mean creatine kinase level increased in the exercise training group whereas it remained stable in the combined group. Conclusions This prospective multicentre study shows that electrical myostimulation on top of exercise training does not demonstrate any significant

  19. Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR).

    Science.gov (United States)

    Baldi, Enrico; Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

    2018-04-19

    Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). ETHICS AND DISSEMINATION: . Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. NCT02632500. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Effects of breathing frequency and flow rate on the total inward leakage of an elastomeric half-mask donned on an advanced manikin headform.

    Science.gov (United States)

    He, Xinjian; Grinshpun, Sergey A; Reponen, Tiina; McKay, Roy; Bergman, Michael S; Zhuang, Ziqing

    2014-03-01

    The objective of this study was to investigate the effects of breathing frequency and flow rate on the total inward leakage (TIL) of an elastomeric half-mask donned on an advanced manikin headform and challenged with combustion aerosols. An elastomeric half-mask respirator equipped with P100 filters was donned on an advanced manikin headform covered with life-like soft skin and challenged with aerosols originated by burning three materials: wood, paper, and plastic (polyethylene). TIL was determined as the ratio of aerosol concentrations inside (C in) and outside (C out) of the respirator (C in/C out) measured with a nanoparticle spectrometer operating in the particle size range of 20-200nm. The testing was performed under three cyclic breathing flows [mean inspiratory flow (MIF) of 30, 55, and 85 l/min] and five breathing frequencies (10, 15, 20, 25, and 30 breaths/min). A completely randomized factorial study design was chosen with four replicates for each combination of breathing flow rate and frequency. Particle size, MIF, and combustion material had significant (P plastic aerosol produced higher mean TIL values than wood and paper aerosols. The effect of the breathing frequency was complex. When analyzed using all combustion aerosols and MIFs (pooled data), breathing frequency did not significantly (P = 0.08) affect TIL. However, once the data were stratified according to combustion aerosol and MIF, the effect of breathing frequency became significant (P plastic combustion aerosol. The effect of breathing frequency on TIL is less significant than the effects of combustion aerosol and breathing flow rate for the tested elastomeric half-mask respirator. The greatest TIL occurred when challenged with plastic aerosol at 30 l/min and at a breathing frequency of 30 breaths/min.

  1. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  2. Synchronous multicentric osteosarcoma: the case for metastases

    International Nuclear Information System (INIS)

    Daffner, R.H.; Kennedy, S.L.; Fox, K.R.; Crowley, J.J.; Sauser, D.D.; Cooperstein, L.A.

    1997-01-01

    Objective. There is a current debate whether multicentric osteosarcoma represents synchronous multiple primary osteosarcomas or metastatic disease. The purpose of this report is to evaluate the etiology, presentation, and classification of this entity. Design and patients. Six patients ranging in age from 7 to 29 years were studied. The clinical, radiographic, and pathologic findings are reported. In addition, a review of the literature was undertaken. Results. The clinical courses of our six patients as well as a review of the literature suggest that multicentric osteosarcoma represent one extreme of a continuous scale of metastatic osteosarcoma rather than multiple synchronous primary tumors. The presentation is unusual and the clinical behavior distinctive, but the mechanism of spread remains the same: blood-borne and lymphatic-borne. Conclusions. Our experience with these six patients supports the concept in the recent literature that synchronous osteosarcoma is one extreme of the spectrum of metastatic osteosarcoma. Its unique features are: (1) multiple radiodense lesions that present simultaneously with or without pulmonary metastases; (2) a single ''dominant'' lesion with multiple smaller lesions; and (3) a uniformly rapid, fatal prognosis. Osteosarcoma should be regarded as a metastatic disease, even when only a single primary lesion is found at the initial presentation. (orig.)

  3. Danazol treatment of benign breast disease: a survey of U.S.A. multi-centre studies.

    Science.gov (United States)

    Brookshaw, J D

    1979-01-01

    514 patients with benign breast disease provided records from multicentre studies in the U.S.A. Results showed that a high proportion responded with either decrease or elimination of symptoms, response usually being apparent 15 to 45 days after commencing treatment. Dosage schedules varied between 50 and 400 mg danazol daily and length of treatment between 15 and 196 days. There was a tendency for patients with more severe symptoms to respond better to the higher dosages, and for the elimination rate for all grades of severity to improve with time. Side effects were not severe, and of the expected type including weight gain, oiliness of skin and hair, and acne.

  4. Comparative activity of tigecycline and tetracycline on Gram-negative and Gram-positive bacteria revealed by a multicentre study in four North European countries

    DEFF Research Database (Denmark)

    Nilsson, Lennart E; Frimodt-Møller, Niels; Vaara, Martti

    2011-01-01

    This study involves a multicentre surveillance of tigecycline and tetracycline activity against Gram-negative and Gram-positive bacteria from primary care centres (PCCs), general hospital wards (GHWs) and intensive care units (ICUs) in Denmark (n = 9), Finland (n = 10), Norway (n = 7) and Sweden (n...

  5. The effect of a standardised source of divided attention in airway management: A randomised, crossover, interventional manikin study.

    Science.gov (United States)

    Prottengeier, Johannes; Petzoldt, Marlen; Jess, Nikola; Moritz, Andreas; Gall, Christine; Schmidt, Joachim; Breuer, Georg

    2016-03-01

    Dual-tasking, the need to divide attention between concurrent tasks, causes a severe increase in workload in emergency situations and yet there is no standardised training simulation scenario for this key difficulty. We introduced and validated a quantifiable source of divided attention and investigated its effects on performance and workload in airway management. A randomised, crossover, interventional simulation study. Center for Training and Simulation, Department of Anaesthesiology, Erlangen University Hospital, Germany. One hundred and fifty volunteer medical students, paramedics and anaesthesiologists of all levels of training. Participants secured the airway of a manikin using a supraglottic airway, conventional endotracheal intubation and video-assisted endotracheal intubation with and without the Paced Auditory Serial Addition Test (PASAT), which served as a quantifiable source of divided attention. Primary endpoint was the time for the completion of each airway task. Secondary endpoints were the number of procedural mistakes made and the perceived workload as measured by the National Aeronautics and Space Administration's task load index (NASA-TLX). This is a six-dimensional questionnaire, which assesses the perception of demands, performance and frustration with respect to a task on a scale of 0 to 100. All 150 participants completed the tests. Volunteers perceived our test to be challenging (99%) and the experience of stress and distraction true to an emergency situation (80%), but still fair (98%) and entertaining (95%). The negative effects of divided attention were reproducible in participants of all levels of expertise. Time consumption and perceived workload increased and almost half the participants make procedural mistakes under divided attention. The supraglottic airway technique was least affected by divided attention. The scenario was effective for simulation training involving divided attention in acute care medicine. The significant effects

  6. Captopril radionuclide test in renovascular hypertension: a European multicentre study

    International Nuclear Information System (INIS)

    Fommei, E.; Ghione, S.; Hilson, A.J.W.; Mezzasalma, L.; Oei, H.Y.; Piepsz, A.; Volterrani, D.

    1993-01-01

    The efficacy of renal scintigraphy with technetium-99m DTPA before and after captopril was evaluated in a multicentre study. All 380 hypertensive patients in the study underwent renal arteriography; 125 had renal arterial stenosis ≥70%, and 54 had a technically successful intervention to correct the stenosis. The post-captopril study had a sensitivity of 93% and a specificity of 100% for predicting blood pressure response to intervention, if renal function was normal and a combination of quantitative parameters was applied. In the entire population renal artery stenosis ≥70% was detected with a sensitivity of 83% and a specificity of 93% if renal function was normal. In patients with abnormal renal function the performance of the test was worse, owing to a lower specificity which could be increased by using only time parameters. The performance of the test was optimal when the post-captopril findings were examined; no improvement was achieved by evaluation of the changes induced by captopril from the baseline. The test can thus be simplified by performing only a post-captopril study for routine use: a negative test would exclude a curable form of renovascular hypertension in right angle 80% and a positive test would predict it in right angle 90% of the patients selected for suspicion of the disease. Usefulness of the scintigraphic test for monitoring the clinical results of intervention is suggested by correlating post-intervention outcome with pre- and post-intervention scintigraphic results. (orig./MG)

  7. Assessment of body mapping sportswear using a manikin operated in constant temperature mode and thermoregulatory model control mode

    Science.gov (United States)

    Wang, Faming; Del Ferraro, Simona; Molinaro, Vincenzo; Morrissey, Matthew; Rossi, René

    2014-09-01

    Regional sweating patterns and body surface temperature differences exist between genders. Traditional sportswear made from one material and/or one fabric structure has a limited ability to provide athletes sufficient local wear comfort. Body mapping sportswear consists of one piece of multiple knit structure fabric or of different fabric pieces that may provide athletes better wear comfort. In this study, the `modular' body mapping sportswear was designed and subsequently assessed on a `Newton' type sweating manikin that operated in both constant temperature mode and thermophysiological model control mode. The performance of the modular body mapping sportswear kit and commercial products were also compared. The results demonstrated that such a modular body mapping sportswear kit can meet multiple wear/thermal comfort requirements in various environmental conditions. All body mapping clothing (BMC) presented limited global thermophysiological benefits for the wearers. Nevertheless, BMC showed evident improvements in adjusting local body heat exchanges and local thermal sensations.

  8. Feasibility of Augmented Reality in Clinical Simulations: Using Google Glass With Manikins.

    Science.gov (United States)

    Chaballout, Basil; Molloy, Margory; Vaughn, Jacqueline; Brisson Iii, Raymond; Shaw, Ryan

    2016-03-07

    Studies show that students who use fidelity-based simulation technology perform better and have higher retention rates than peers who learn in traditional paper-based training. Augmented reality is increasingly being used as a teaching and learning tool in a continual effort to make simulations more realistic for students. The aim of this project was to assess the feasibility and acceptability of using augmented reality via Google Glass during clinical simulation scenarios for training health science students. Students performed a clinical simulation while watching a video through Google Glass of a patient actor simulating respiratory distress. Following participation in the scenarios students completed two surveys and were questioned if they would recommend continued use of this technology in clinical simulation experiences. We were able to have students watch a video in their field of vision of a patient who mimicked the simulated manikin. Students were overall positive about the implications for being able to view a patient during the simulations, and most students recommended using the technology in the future. Overall, students reported perceived realism with augmented reality using Google Glass. However, there were technical and usability challenges with the device. As newer portable and consumer-focused technologies become available, augmented reality is increasingly being used as a teaching and learning tool to make clinical simulations more realistic for health science students. We found Google Glass feasible and acceptable as a tool for augmented reality in clinical simulations.

  9. [Sentinel node biopsy in patients with multifocal and multicentric breast cancer: A 5-year follow-up].

    Science.gov (United States)

    Blanco Saiz, I; López Carballo, M T; Martínez Fernández, J; Carrión Maldonado, J; Cabrera Pereira, A; Moral Alvarez, S; Santamaría Girón, L; Cantero Cerquella, F; López Secades, A; Díaz González, D; Llaneza Folgueras, A; Aira Delgado, F J

    2014-01-01

    Sentinel lymph node biopsy (SLNB) as a staging procedure in multiple breast cancer is a controversial issue. We have aimed to evaluate the efficacy of sentinel node (SN) detection in patients with multifocal or multicentric breast cancer as well as the safety of its clinical application after a long follow-up. A prospective descriptive study was performed. Eighty-nine patients diagnosed of multiple breast cancer (73 multifocal; 16 multicentric) underwent SLNB. These patients were compared to those with unifocal neoplasia. Periareolar radiocolloid administration was performed in most of the patients. Evaluation was made at an average of 67.2 months of follow-up (32-126 months). Scintigraphic and surgical SN localization in patients with multiple breast cancer were 95.5% and 92.1%, respectively. A higher percentage of extra-axillary nodes was observed than in the unifocal group (11.7% vs 5.4%) as well as a significantly higher number of SN per patient (1.70 vs 1.38). The rate of SN localization in multicentric cancer was slightly lower than in multifocal cancer (87.5% vs 93.1%), and the finding of extra-axillary drainages was higher (20% vs 10%). Number of SN per patient was significantly higher in multicentric breast cancer (2.33 vs 1.57). No axillary relapses have been demonstrated in the follow-up in multiple breast cancer patients group. SLNB performed by periareolar injection is a reliable and accurate staging procedure of patients with multiple breast cancer, including those with multicentric processes. Copyright © 2013 Elsevier España, S.L. and SEMNIM. All rights reserved.

  10. Training mothers in infant cardiopulmonary resuscitation with an instructional DVD and manikin.

    Science.gov (United States)

    Barr, Gavin C; Rupp, Valerie A; Hamilton, Kimberly M; Worrilow, Charles C; Reed, James F; Friel, Kristin S; Dusza, Stephen W; Greenberg, Marna Rayl

    2013-07-01

    Classes in infant cardiopulmonary resuscitation (CPR) can be time consuming and costly. To determine whether mothers in an obstetric unit could learn infant CPR by using a 22-minute instructional kit and to assess the value and confidence they gained by learning CPR. Quasi-experimental study with enrollment between January and December 2008. Obstetric unit in Lehigh Valley Hospital, a suburban teaching hospital in Allentown, Pennsylvania. Mothers at least 18 years old who had given birth within the previous 24 hours. The experimental group included mothers without prior CPR training who watched a 22-minute instructional DVD and practiced on a manikin. The control group included mothers with prior conventional CPR training. In both groups, knowledge and proficiency were assessed with written and practical examinations developed by certified CPR instructors. Participant surveys were conducted at 3 times: immediately before dissemination of course materials, within 24 hours after the mother agreed to participate in the study, and 6 months after initial evaluation. A total of 126 mothers were enrolled in the study: 79 in the experimental group, 25 in the control group, and 22 who withdrew from the study. Written and practical examinations were used to determine proficiency, and composite scores were generated, with a maximum composite score of 12. The composite scores were statistically significantly higher in the experimental group than in the control group, with median scores of 10 and 7, respectively (PCPR training. In the experimental group, 76 mothers (96%) felt more confident as caregivers after learning CPR. Before training in both groups, 84 mothers (81%) stated that learning CPR was extremely important, compared with 100 mothers (96%) after training (P=.001). Use of an instructional kit is an effective method of teaching CPR to new mothers. Mothers reported that learning CPR is extremely important and that it increases their confidence as caregivers.

  11. An international multicentre study on the allergenic activity of air-oxidized R-limonene

    DEFF Research Database (Denmark)

    Bråred Christensson, Johanna; Andersen, Klaus Ejner; Bruze, Magnus

    2013-01-01

    Background. Limonene is a common fragrance terpene that, in its pure form, is not allergenic or is a very weak allergen. However, limonene autoxidizes on air exposure, and the oxidation products can cause contact allergy. Oxidized R-limonene has previously been patch tested in multicentre studies......, giving 2-3% positive patch test reactions in consecutive patients. Objectives. To investigate whether oxidized R-limonene 3.0% in petrolatum, with a stable concentration of the main haptens, limonene hydroperoxides (Lim-OOHs), could be a useful tool for the detection of contact allergy...... in an international setting. Methods. Oxidized R-limonene 3.0% (Lim-OOHs 0.33%) pet. was tested in 2900 consecutive dermatitis patients in Denmark, the United Kingdom, Singapore, Spain, Sweden, and Australia. Results. Overall, 5.2% (range 2.3-12.1%) of the patients showed a positive patch test reaction to oxidized R...

  12. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

    2015-01-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for th...

  13. Multicentre quality assurance of intensity-modulated radiation therapy plans: a precursor to clinical trials

    International Nuclear Information System (INIS)

    Williams, M. J.; Bailey, M. J.; Forstner, D.; Metcalfe, P. E

    2007-01-01

    Full text: A multicentre planning study comparing intensity-modulated radiation therapy (IMRT) plans for the treatment of a head and neck cancer has been carried out. Three Australian radiotherapy centres, each with a different planning system, were supplied a fully contoured CT dataset and requested to generate an IMRT plan in accordance with the requirements of an IMRT-based radiation therapy oncology group clinical trial. Plan analysis was carried out using software developed specifically for reviewing multicentre clinical trial data. Two out of the three plans failed to meet the prescription requirements with one misinterpreting the prescription and the third failed to meet one of the constraints. Only one plan achieved all of the dose objectives for the critical structures and normal tissues. Although each centre used very similar planning parameters and beam arrangements the resulting plans were quite different. The subjective interpretation and application of the prescription and planning objectives emphasize one of the many difficulties in carrying out multicentre IMRT planning studies. The treatment prescription protocol in a clinical trial must be both lucid and unequivocally stated to avoid misinterpretation. Australian radiotherapy centres must show that they can produce a quality IMRT plan and that they can adhere to protocols for IMRT planning before using it in a clinical trial

  14. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

    2015-01-01

    to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference...... to the original source....

  15. Multicentric Castleman's disease & HIV infection.

    LENUS (Irish Health Repository)

    Cotter, A

    2009-10-01

    We report the case of a 35 year patient from Nigeria who presented with fever and splenomegaly. The initial diagnosis was Salmonellosis. However, relapsing symptoms lead to a re-evaluation and ultimately a diagnosis of Multicentric Castleman\\'s Disease (MCD). There is no gold standard treatment but our patient responded to Rituximab and Highly active anti-retroviral therapy. MCD is a rare, aggressive disease that should be considered in a HIV positive patient presenting with fever and significant lymphadenopathy.

  16. Prophylactic antibiotic regimens in tumour surgery (PARITY) : a pilot multicentre randomised controlled trial

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

  17. Problem-solving ability and repetition of deliberate self-harm: a multicentre study.

    Science.gov (United States)

    McAuliffe, Carmel; Corcoran, Paul; Keeley, Helen S; Arensman, Ella; Bille-Brahe, Unni; De Leo, Diego; Fekete, Sandor; Hawton, Keith; Hjelmeland, Heidi; Kelleher, Margaret; Kerkhof, Ad J F M; Lönnqvist, Jouko; Michel, Konrad; Salander-Renberg, Ellinor; Schmidtke, Armin; Van Heeringen, Kees; Wasserman, Danuta

    2006-01-01

    While recent studies have found problem-solving impairments in individuals who engage in deliberate self-harm (DSH), few studies have examined repeaters and non-repeaters separately. The aim of the present study was to investigate whether specific types of problem-solving are associated with repeated DSH. As part of the WHO/EURO Multicentre Study on Suicidal Behaviour, 836 medically treated DSH patients (59% repeaters) from 12 European regions were interviewed using the European Parasuicide Study Interview Schedule (EPSIS II) approximately 1 year after their index episode. The Utrecht Coping List (UCL) assessed habitual responses to problems. Factor analysis identified five dimensions--Active Handling, Passive-Avoidance, Problem Sharing, Palliative Reactions and Negative Expression. Passive-Avoidance--characterized by a pre-occupation with problems, feeling unable to do anything, worrying about the past and taking a gloomy view of the situation, a greater likelihood of giving in so as to avoid difficult situations, the tendency to resign oneself to the situation, and to try to avoid problems--was the problem-solving dimension most strongly associated with repetition, although this association was attenuated by self-esteem. The outcomes of the study indicate that treatments for DSH patients with repeated episodes should include problem-solving interventions. The observed passivity and avoidance of problems (coupled with low self-esteem) associated with repetition suggests that intensive therapeutic input and follow-up are required for those with repeated DSH.

  18. Attachment Styles of Dermatological Patients in Europe: A Multi-centre Study in 13 Countries.

    Science.gov (United States)

    Szabó, Csanád; Altmayer, Anita; Lien, Lars; Poot, Françoise; Gieler, Uwe; Tomas-Aragones, Lucía; Kupfer, Jörg; Jemec, Gregor B E; Misery, Laurent; Linder, M Dennis; Sampogna, Francesca; van Middendorp, Henriët; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek C; Romanov, Dmitry; Marron, Servando E; Altunay, Ilknur K; Finlay, Andrew Y; Salek, Sam S; Dalgard, Florence

    2017-07-06

    Attachment styles of dermatological outpatients and satisfaction with their dermatologists were investigated within the framework of a multicentre study conducted in 13 European countries, organized by the European Society for Dermatology and Psychiatry. Attachment style was assessed with the Adult Attachment Scale. Patient satisfaction with the dermatologist was assessed with an 11-degree scale. A total of 3,635 adult outpatients and 1,359 controls participated in the study. Dermatological outpatients were less able to depend on others, were less comfortable with closeness and intimacy, and experienced similar rates of anxiety in relationships as did the controls. Participants who had secure attachment styles reported stressful life events during the last 6 months significantly less often than those who had insecure attachment styles. Patients with secure attachment styles tended to be more satisfied with their dermatologist than did insecure patients. These results suggest that secure attachment of dermatological outpatients may be a protective factor in the management of stress.

  19. Cognition and bimanual performance in children with unilateral cerebral palsy: protocol for a multicentre, cross-sectional study.

    Science.gov (United States)

    Hoare, Brian; Ditchfield, Michael; Thorley, Megan; Wallen, Margaret; Bracken, Jenny; Harvey, Adrienne; Elliott, Catherine; Novak, Iona; Crichton, Ali

    2018-05-08

    Motor outcomes of children with unilateral cerebral palsy are clearly documented and well understood, yet few studies describe the cognitive functioning in this population, and the associations between the two is poorly understood. Using two hands together in daily life involves complex motor and cognitive processes. Impairment in either domain may contribute to difficulties with bimanual performance. Research is yet to derive whether, and how, cognition affects a child's ability to use their two hands to perform bimanual tasks. This study will use a prospective, cross-sectional multi-centre observational design. Children (aged 6-12 years) with unilateral cerebral palsy will be recruited from one of five Australian treatment centres. We will examine associations between cognition, bimanual performance and brain neuropathology (lesion type and severity) in a sample of 131 children. The primary outcomes are: Motor - the Assisting Hand Assessment; Cognitive - Executive Function; and Brain - lesion location on structural MRI. Secondary data collected will include: Motor - Box and Blocks, ABILHAND- Kids, Sword Test; Cognitive - standard neuropsychological measures of intelligence. We will use generalized linear modelling and structural equation modelling techniques to investigate relationships between bimanual performance, executive function and brain lesion location. This large multi-centre study will examine how cognition affects bimanual performance in children with unilateral cerebral palsy. First, it is anticipated that distinct relationships between bimanual performance and cognition (executive function) will be identified. Second, it is anticipated that interrelationships between bimanual performance and cognition will be associated with common underlying neuropathology. Findings have the potential to improve the specificity of existing upper limb interventions by providing more targeted treatments and influence the development of novel methods to improve both

  20. Experimental Study Abour How the Thermal Plume Affects the Air Quality a Person Breathes

    DEFF Research Database (Denmark)

    Olmedo, Inés; Nielsen, Peter V.; Ruiz de Adana, Manuel

    2011-01-01

    of this research is to increase the knowledge of how the thermal plume generated by a person affects the PME and therefore the concentration of contaminants in the inhalation area. An experimental study in a displacement ventilation room was carried out. Experiments were developed in a full scale test chamber 4.......10 m (length), 3.2 m (width), 2.7 m (height). The incoming air is distributed through a wall-mounted displacement diffuser. A breathing thermal manikin exhaling through the mouth and inhaling through the nose was used. A tracer gas, N2O, was used to simulate the gaseous substances, which might...... be considered as biological contaminants, exhaled by the manikin. The manikin was operated in three different heat fluxes with a value of: 0W, 94 W and 120 W. During the experiments six concentration probes were situated in the room. Three concentration tubes were fixed on the surface of the manikin at three...

  1. 'Away Days' in multi-centre randomised controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

    Science.gov (United States)

    Jefferson, Laura; Cook, Liz; Keding, Ada; Brealey, Stephen; Handoll, Helen; Rangan, Amar

    2015-11-06

    'Away Days' (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multi-centre randomised controlled trials (RCTs). We explored the use of Away Days in multi-centre RCTs and analysed the effect on patient recruitment in a case study. Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multi-centre pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. A total of 94 people responded to the survey. The majority (78%), who confirmed had organised an Away Day previously, found them to be useful. This is despite their costs.. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multi-centre surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  2. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  3. A comparison of functional outcome in patients sustaining major trauma: a multicentre, prospective, international study.

    Directory of Open Access Journals (Sweden)

    Timothy H Rainer

    Full Text Available OBJECTIVES: To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. SUMMARY BACKGROUND DATA: Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR. METHODS: Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE functional outcome and risk-adjusted Short-Form 12 (SF-12 health status at 6 and 12 months after injury. RESULTS: 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17, and at 12 months was 0.83 (95% CI: 0.60, 1.12. Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: -1.2, 3.6 and 12-months (adjusted mean difference: -0.4, 95% CI: -3.2, 2.4 compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: -2.1, 2.8 or 12-months (adjusted mean difference: 1.8, 95% CI: -0.8, 4.5. CONCLUSION: The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions.

  4. A Comparison of Functional Outcome in Patients Sustaining Major Trauma: A Multicentre, Prospective, International Study

    Science.gov (United States)

    Rainer, Timothy H.; Yeung, Hiu Hung; Gabbe, Belinda J.; Yuen, Kai Y.; Ho, Hiu F.; Kam, Chak W.; Chang, Annice; Poon, Wai S.; Cameron, Peter A.; Graham, Colin A.

    2014-01-01

    Objectives To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. Summary Background Data Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR). Methods Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE) functional outcome and risk-adjusted Short-Form 12 (SF-12) health status at 6 and 12 months after injury. Results 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17), and at 12 months was 0.83 (95% CI: 0.60, 1.12). Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: −1.2, 3.6) and 12-months (adjusted mean difference: −0.4, 95% CI: −3.2, 2.4) compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: −2.1, 2.8) or 12-months (adjusted mean difference: 1.8, 95% CI: −0.8, 4.5). Conclusion The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions. PMID:25157522

  5. 99mTc-DTPA aerosol for same-day post-perfusion ventilation imaging: Results of a multicentre study

    International Nuclear Information System (INIS)

    Koehn, H.; Koenig, B.; Bachmayr, S.; Markt, B.; Eber, O.; Lind, P.; Galvan, G.; Rettenbacher, L.; Holm, C.; Ogris, E.

    1993-01-01

    A multicentre study was performed in an attempt to evaluate a submicronic technetium-99m diethylene triamine penta-acetic acid aerosol generated by a newly developed delivery system, the aerosol production equipment (APE nebulizer), for same-day post-perfusion ventilation imaging in patients with clinically suspected pulmonary embolism. Quantitative comparison between the DTPA aerosol and krypton gas demonstrated a close correlation with respect to regional pulmonary distribution of activity and peripheral lung penetration (n=14, r=0.94, P 99m Tc-labelled DTPA aerosol is well suited for fast same-day post-perfusion ventilation imaging in patients with clinical suspicion of pulmonary embolism. (orig.)

  6. Rhenium-188 Lipiodol Therapy of Hepatocellular Carcinoma: Results of a multicentre-multinational study

    International Nuclear Information System (INIS)

    Padhy, A.K.; Bernal, P.; Buscombe, R.J.

    2007-01-01

    Full text: A multi-centre study was sponsored by the IAEA to assess the safety and efficacy of trans-arterial Rhenium-188 HDD Lipiodol in the treatment of inoperable Hepatocellular Carcinoma. The radioconjugate was prepared by using an HDD kit and Lipiodol. Over three years, 185 patients received at least one treatment. The dose administered was based on radiation absorbed dose to critical normal organs, calculated following a ''scout'' dose (approximately 4 mCi) of radioconjugate. The organs at greatest risk for radiation toxicity are the liver, the lung and the bone marrow. An Excel spreadsheet was used to determine maximum tolerated activity, defined as the amount of radioactivity calculated to deliver no more than 12 Gy to lungs, 30 Gy to liver, or 1.5 Gy to bone marrow. A single treatment was given to 134 patients, 42 patients received two doses, 8 received three and one patient received four treatments. The total injected activity including the scout dose during the first treatment ranged from 21 to 364 mCi (average 108 mCi). Patients were followed for at least l2 weeks after therapy. The clinical parameters evaluated included toxicity, response as determined objectively by contrast enhanced computed tomography, palliation of symptoms, overall survival, performance status (Karnofsky), and hepatic function (Child's classification). Liver function tests, serum alpha-fetoprotein (AFP) levels and complete blood counts were done at each follow-up visit. Side effects were minimal and usually presented as loss of appetite, right hypochondrial discomfort and low-grade fever. Liver function tests at 24 and 72 hours showed no significant changes and complete blood counts at 1 week, 4 weeks and 12 weeks showed no changes (no bone marrow suppression). Data on largest tumour diameter after therapy and/or tumour response as evaluated from CT scans are available for 88 patients. Complete disappearance of tumour was recorded in 3 (3%), partial response in 19 (22%), stable

  7. Multicentre evaluation of a novel vaginal dose reporting method in 153 cervical cancer patients

    DEFF Research Database (Denmark)

    Westerveld, Henrike; de Leeuw, Astrid; Kirchheiner, Kathrin

    2016-01-01

    Background and purpose Recently, a vaginal dose reporting method for combined EBRT and BT in cervical cancer patients was proposed. The current study was to evaluate vaginal doses with this method in a multicentre setting, wherein different applicators, dose rates and protocols were used. Materia...

  8. Experimental study on centerline velocities of a rectangular capture hood under realistic conditions.

    Science.gov (United States)

    He, Xinjian; Lewis, Braxton V; Guffey, Steven E

    2018-02-01

    Capture hoods are an important component of a local ventilation system designed to reduce exposures to airborne contaminants. The velocity at any point along the centerline of the hood (V x ) is currently estimated using one of many predictive equations developed since the 1930s. It is unproven that those predictive equations for V x are accurate, despite the prodigious number of studies concerning them. Among other issues, almost all experimental verifications were conducted for conditions that were either unrealistically ideal without competing air currents (e.g., zero cross draft) or were not described. This study measured values of V x along the midline using Particle Image Velocimetry (PIV) at distances of 1-14 inches in front of a rectangular capture hood. The experiments were conducted in a large wind tunnel (9' × 12' × 40', H × W × L) using a heated, breathing, anthropomorphically sized manikin. Three 0 degree draft velocities (V draft = 4, 14, and 50 ft/min) were tested, all directed toward the hood face and the back of the manikin (if present). For each value of V draft , the velocity fields were measured in a factorial design with and without the manikin, and with and without a worktable underneath the hood. An ideal condition was represented by a freestanding hood at the 4 fpm draft. Nonideal conditions included the presence of a worktable or manikin, and the combination of table and manikin. Each condition was tested at the three levels of V draft . The experimental results found significant effects (p < 0.001) for V draft , the presence of the manikin, the presence of the worktable, and all combinations of those factors. The effects of the independent variables were most pronounced at distances greater than 10 in (25.4 cm) from the hood face. It is concluded that none of the previously published models accurately predicted V x under the realistic conditions tested in this study. A satisfactory model will have to include terms for V draft and the

  9. Effect of one-rescuer compression/ventilation ratios on cardiopulmonary resuscitation in infant, pediatric, and adult manikins.

    Science.gov (United States)

    Srikantan, Shoba Krishnan; Berg, Robert A; Cox, Tim; Tice, Lisa; Nadkarni, Vinay M

    2005-05-01

    Optimal chest compression to ventilation ratio (C:V) for one-rescuer cardiopulmonary resuscitation (CPR) is not known, with current American Heart Association recommendations 3:1 for newborns, 5:1 for children, and 15:2 for adults. C:V ratios influence effectiveness of CPR, but memorizing different ratios is educationally cumbersome. We hypothesized that a 10:2 ratio might provide adequate universal application for all age arrest victims. Clinical study. Tertiary care children's hospital. Thirty-five health care providers. Thirty-five health care providers performed 5-min epochs of one-rescuer CPR at C:V ratios of 3:1, 5:1, 10:2, and 15:2 in random order on infant, pediatric, and adult manikins. Compressions were paced at 100/min by metronome. The number of effective compressions and ventilations delivered per minute was recorded by a trained basic life support instructor. Subjective assessments of fatigue (self-report) and exertion (change in rescuer pulse rate compared with baseline) were assessed. Analysis was by repeated measures analysis of variance and paired Student's t-test. Effective infant compressions per minute did not differ by C:V ratio, but ventilations per minute were greater at 3:1 vs. 5:1, 10:2, and 15:2 (p 15:2 (p educational value and technique retention.

  10. Coping strategies for postpartum depression: a multi-centric study of 1626 women.

    Science.gov (United States)

    Gutiérrez-Zotes, Alfonso; Labad, Javier; Martín-Santos, Rocío; García-Esteve, Luisa; Gelabert, Estel; Jover, Manuel; Guillamat, Roser; Mayoral, Fermín; Gornemann, Isolde; Canellas, Francesca; Gratacós, Mónica; Guitart, Montserrat; Roca, Miguel; Costas, Javier; Ivorra, Jose Luis; Navinés, Ricard; de Diego-Otero, Yolanda; Vilella, Elisabet; Sanjuan, Julio

    2016-06-01

    The transition to motherhood is stressful as it requires several important changes in family dynamics, finances, and working life, along with physical and psychological adjustments. This study aimed at determining whether some forms of coping might predict postpartum depressive symptomatology. A total of 1626 pregnant women participated in a multi-centric longitudinal study. Different evaluations were performed 8 and 32 weeks after delivery. Depression was assessed using the Edinburgh Postnatal Depression Scale (EPDS) and the structured Diagnostic Interview for Genetic Studies (DIGS). The brief Coping Orientation for Problem Experiences (COPE) scale was used to measure coping strategies 2-3 days postpartum. Some coping strategies differentiate between women with and without postpartum depression. A logistic regression analysis was used to explore the relationships between the predictors of coping strategies and major depression (according to DSM-IV criteria). In this model, the predictor variables during the first 32 weeks were self-distraction (OR 1.18, 95 % CI 1.04-1.33), substance use (OR 0.58, 95 % CI 0.35-0.97), and self-blame (OR 1.18, 95 % CI 1.04-1.34). In healthy women with no psychiatric history, some passive coping strategies, both cognitive and behavioral, are predictors of depressive symptoms and postpartum depression and help differentiate between patients with and without depression.

  11. Comparison of manual and semi-automatic measuring techniques in MSCT scans of patients with lymphoma: a multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Hoeink, A.J.; Wessling, J.; Schuelke, C.; Kohlhase, N.; Wassenaar, L.; Heindel, W.; Buerke, B. [University Hospital Muenster, Department of Clinical Radiology, Muenster (Germany); Koch, R. [University of Muenster, Institute of Biostatistics and Clinical Research (IBKF), Muenster (Germany); Mesters, R.M. [University Hospital Muenster, Department of Haematology and Oncology, Muenster (Germany); D' Anastasi, M.; Graser, A.; Karpitschka, M. [University Hospital Muenchen (LMU), Institute of Clinical Radiology, Muenchen (Germany); Fabel, M.; Wulff, A. [University Hospital Kiel, Department of Clinical Radiology, Kiel (Germany); Pinto dos Santos, D. [University Hospital Mainz, Department of Diagnostic and Interventional Radiology, Mainz (Germany); Kiessling, A. [University Hospital Marburg, Department of Diagnostic and Interventional Radiology, Marburg (Germany); Dicken, V.; Bornemann, L. [Institute of Medical Imaging Computing, Fraunhofer MeVis, Bremen (Germany)

    2014-11-15

    Multicentre evaluation of the precision of semi-automatic 2D/3D measurements in comparison to manual, linear measurements of lymph nodes regarding their inter-observer variability in multi-slice CT (MSCT) of patients with lymphoma. MSCT data of 63 patients were interpreted before and after chemotherapy by one/tworadiologists in five university hospitals. In 307 lymph nodes, short (SAD)/long (LAD) axis diameter and WHO area were determined manually and semi-automatically. Volume was solely calculated semi-automatically. To determine the precision of the individual parameters, a mean was calculated for every lymph node/parameter. Deviation of the measured parameters from this mean was evaluated separately. Statistical analysis entailed intraclass correlation coefficients (ICC) and Kruskal-Wallis tests. Median relative deviations of semi-automatic parameters were smaller than deviations of manually assessed parameters, e.g. semi-automatic SAD 5.3 vs. manual 6.5 %. Median variations among different study sites were smaller if the measurement was conducted semi-automatically, e. g. manual LAD 5.7/4.2 % vs. semi-automatic 3.4/3.4 %. Semi-automatic volumetry was superior to the other parameters (2.8 %). Semi-automatic determination of different lymph node parameters is (compared to manually assessed parameters) associated with a slightly greater precision and a marginally lower inter-observer variability. These results are with regard to the increasing mobility of patients among different medical centres and in relation to the quality management of multicentre trials of importance. (orig.)

  12. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

    Full Text Available Abstract Background The International Multi-centre ADHD Genetics (IMAGE project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit/hyperactivity disorder (ADHD-CT and 1446 'unselected' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities. A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS interview and the DSM-IV items of the Conners' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive

  13. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns.

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

    Abstract Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit\\/hyperactivity disorder (ADHD-CT) and 1446 \\'unselected\\' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres) and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities). A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS) interview and the DSM-IV items of the Conners\\' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands) were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband\\/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive

  14. One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study.

    Science.gov (United States)

    Walther, Thomas; Thielmann, Matthias; Kempfert, Joerg; Schroefel, Holger; Wimmer-Greinecker, Gerhard; Treede, Hendrik; Wahlers, Thorsten; Wendler, Olaf

    2013-05-01

    The study aimed to evaluate 1-year outcomes of the multicentre PREVAIL transapical (TA) study of TA-aortic valve implantation (AVI) in high-risk patients. From September 2009 to August 2010, a total of 150 patients, aged 81.6 ± 5.8 years, 40.7% female, were included at 12 European TA-AVI experienced sites. Patients received 23 (n = 36), 26 (n = 57) and 29 mm (n = 57) second-generation SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) valves. The mean logistic EuroSCORE was 24.3 ± 7.0, and mean Society Thoracic Surgeons score was 7.5 ± 4.4%. Survival was 91.3% at 30 days and 77.9% at 1 year. Subgroup analysis revealed survivals of 91.7/88.9, 86.0/70.2, 96.55/91.2% for patients receiving 23-, 26- and 29-mm valves at 30 days and at 1 year, respectively. Transthoracic echocardiography revealed preserved left ventricular ejection fraction and low gradients. Aortic incompetence was none in 41/48, trace 30/36, mild 22/12 and moderate in 7/4% at discharge and 1 year. Walking distance increased from 221 (postimplant) to 284 m (at 1 year, P = 0.0004). Three patients required reoperation due to increasing aortic incompetence during follow-up. Causes of mortality at 1 year were cardiac (n = 7), stroke (n = 1) and others (n = 5). The European PREVAIL multicentre trial demonstrates good functionality and good outcomes for TA-AVI using the second-generation SAPIEN XT prosthesis and the ASCENDRA-II delivery system. The 29-mm SAPIEN XT valve was successfully introduced and showed excellent results.

  15. Multicentric primary extramammary Paget disease: a Toker cell disorder?

    Science.gov (United States)

    Hashemi, Pantea; Kao, Grace F; Konia, Thomas; Kauffman, Lisa C; Tam, Christine C; Sina, Bahram

    2014-07-01

    Toker cells are epithelial clear cells found in the areolar and nipple areas of the breast, vulvar region, and other apocrine gland-bearing areas of the skin. Toker cells have been implicated in the pathogenesis of clear cell papulosis, cutaneous hamartoma with pagetoid cells, and rare cases of primary extramammary Paget disease (EMPD) but not in secondary EMPD with underlying adenocarcinoma. The pathogenesis of primary EMPD is not well defined. We report a case of multicentric primary EMPD with evidence of Toker cell proliferation and nonaggressive biologic behavior in a 63-year-old white man. A detailed description of the morphologic and biologic features of Toker cells and their possible carcinogenetic links also are discussed. Based on the observation and follow-up of our patient, we hypothesize that multicentric primary EMPD starts with Toker cell hyperplasia and can potentially evolve to carcinoma in the genital region.

  16. Homeopathy in chronic sinusitis: a prospective multi-centric observational study.

    Science.gov (United States)

    Nayak, Chaturbhuja; Singh, Vikram; Singh, V P; Oberai, Praveen; Roja, Varanasi; Shitanshu, Shashi Shekhar; Sinha, M N; Deewan, Deepti; Lakhera, B C; Ramteke, Sunil; Kaushik, Subhash; Sarkar, Sarabjit; Mandal, N R; Mohanan, P G; Singh, J R; Biswas, Sabyasachi; Mathew, Georgekutty

    2012-04-01

    The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS). Multicentre observational study at Institutes and Units of the Central Council for Research in Homoeopathy, India. Symptoms were assessed using the chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were shortlisted for prescription on the basis of repertorisation for the pathological symptoms of CS. Regimes and adjustment of regimes in the event of a change of symptoms were pre-defined. The follow-up period was for 6 months. Statistical analysis was done using SPSS version 16. 628 patients suffering from CS confirmed on X-ray were enrolled from eight Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients with at least one follow-up assessment were analyzed. There was a statistically significant reduction in CSAS (P = 0.0001, Friedman test) after 3 and 6 months of treatment. Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having marked improvement. 4/17 medicines were never prescribed. No complications were observed during treatment. Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation. Copyright © 2012 Elsevier Ltd. All rights reserved.

  17. Intra- and interobserver analysis in the morphological assessment of early stage embryos during an IVF procedure: a multicentre study

    Directory of Open Access Journals (Sweden)

    Devroe Johanna

    2011-09-01

    Full Text Available Abstract Background Quality control programs are necessary to maintain good clinical practice. Embryo grading has been described as one of the external quality assurance schemes. Although the evaluation of embryos is based on the assessment of morphological characteristics, considerable intra- and inter-observer variability has been described. In this multicentre study, the variability in the embryo evaluation has been evaluated using morphological characteristics on day 1, day 2 and day 3 of embryo development. Methods Five embryologists of four different IVF centers participated in this study. Multilevel images of embryos were presented on a website at different time points to evaluate intra-and inter-observer agreement in the assessment of embryo morphology. The embryos were evaluated on day 1, day 2 and day 3 of their development and each embryologist had to decide if the embryo had to be transferred, cryopreserved or discarded. Results Both intra-observer agreement and inter-observer agreement were good to excellent for the position of the pronuclei on day 1, the number of blastomeres on day 2 and day 3 and the clinical decision (transfer, cryopreservation, discard. For all other characteristics (size of pronuclei, presence of cytoplasomic halo, degree of fragmentation and size of blastomeres the intra- and inter-observer agreement was moderate to very poor. Conclusions Mono- or multicentre quality control on embryo scoring by morphological assessment can easily be performed through the design of a simple website. In the future the website design can be adapted to generate statistical feedback upon scoring and can even include a training module.

  18. How do different brands of size 1 laryngeal mask airway compare with face mask ventilation in a dedicated laryngeal mask airway teaching manikin?

    Science.gov (United States)

    Tracy, Mark Brian; Priyadarshi, Archana; Goel, Dimple; Lowe, Krista; Huvanandana, Jacqueline; Hinder, Murray

    2018-05-01

    International neonatal resuscitation guidelines recommend the use of laryngeal mask airway (LMA) with newborn infants (≥34 weeks' gestation or >2 kg weight) when bag-mask ventilation (BMV) or tracheal intubation is unsuccessful. Previous publications do not allow broad LMA device comparison. To compare delivered ventilation of seven brands of size 1 LMA devices with two brands of face mask using self-inflating bag (SIB). 40 experienced neonatal staff provided inflation cycles using SIB with positive end expiratory pressure (PEEP) (5 cmH 2 O) to a specialised newborn/infant training manikin randomised for each LMA and face mask. All subjects received prior education in LMA insertion and BMV. 12 415 recorded inflations for LMAs and face masks were analysed. Leak detected was lowest with i-gel brand, with a mean of 5.7% compared with face mask (triangular 42.7, round 35.7) and other LMAs (45.5-65.4) (p<0.001). Peak inspiratory pressure was higher with i-gel, with a mean of 28.9 cmH 2 O compared with face mask (triangular 22.8, round 25.8) and other LMAs (14.3-22.0) (p<0.001). PEEP was higher with i-gel, with a mean of 5.1 cmH 2 O compared with face mask (triangular 3.0, round 3.6) and other LMAs (0.6-2.6) (p<0.001). In contrast to other LMAs examined, i-gel had no insertion failures and all users found i-gel easy to use. This study has shown dramatic performance differences in delivered ventilation, mask leak and ease of use among seven different brands of LMA tested in a manikin model. This coupled with no partial or complete insertion failures and ease of use suggests i-gel LMA may have an expanded role with newborn resuscitation as a primary resuscitation device. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Pregnancy outcomes in Lebanese women with multiple sclerosis (the LeMS study): a prospective multicentre study.

    Science.gov (United States)

    Fares, Jawad; Nassar, Anwar H; Gebeily, Souheil; Kobeissy, Firas; Fares, Youssef

    2016-05-13

    The Lebanese Multiple Sclerosis (LeMS) study aims to assess the influence of pregnancy and delivery on the clinical course of multiple sclerosis (MS) in Lebanese women. This prospective multicentre study took place in three MS referral university medical centres in Lebanon. Included were 29 women over 18 years who had been diagnosed with MS according to the McDonald criteria, and became pregnant between 1995 and 2015. Participating women should have stopped treatment 3 months before conception and become pregnant after the onset of MS. Women were followed up from 1 year preconceptionally and for 4 years postpartum. The annualised relapse rates per participant during each 3-month period during pregnancy and each year postpartum were compared with the relapse rate during the year before pregnancy using the paired two-tailed t test. p Values women with MS does not seem to increase the risk of complications. No relapses were observed during pregnancy and in the first year postpartum; however, relapses rebounded in the second year postpartum, and over the long term, returned to the levels that preceded pregnancy. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  20. Obstetric risk indicators for labour dystocia in nulliparous women: A multi-centre cohort study

    Science.gov (United States)

    Kjærgaard, Hanne; Olsen, Jørn; Ottesen, Bent; Nyberg, Per; Dykes, Anna-Karin

    2008-01-01

    Background In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. Methods A multi-centre population based cohort study with prospectively collected data from 2810 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR) and 95% confidence intervals (CI) are given. Results The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix dystocia. Conclusion Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern. PMID:18837972

  1. Obstetric risk indicators for labour dystocia in nulliparous women: A multi-centre cohort study

    Directory of Open Access Journals (Sweden)

    Ottesen Bent

    2008-10-01

    Full Text Available Abstract Background In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. Methods A multi-centre population based cohort study with prospectively collected data from 2810 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR and 95% confidence intervals (CI are given. Results The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI: dilatation of cervix Conclusion Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern.

  2. Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study

    Directory of Open Access Journals (Sweden)

    Grant Adrian M

    2006-12-01

    Full Text Available Abstract Background Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS. Methods In-depth semi-structured telephone interviews were conducted in 2003–04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. Results The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. Conclusion This study highlights complex financial aspects of planning and conducting trials, especially where multiple

  3. Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study.

    Science.gov (United States)

    Snowdon, Claire; Elbourne, Diana R; Garcia, Jo; Campbell, Marion K; Entwistle, Vikki A; Francis, David; Grant, Adrian M; Knight, Rosemary C; McDonald, Alison M; Roberts, Ian

    2006-12-21

    Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS). In-depth semi-structured telephone interviews were conducted in 2003-04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion) were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. This study highlights complex financial aspects of planning and conducting trials, especially where multiple funders are involved. Recognition of the importance of financial

  4. A multicentre study of 513 Danish patients with systemic lupus erythematosus. II. Disease mortality and clinical factors of prognostic value

    DEFF Research Database (Denmark)

    Jacobsen, S; Petersen, J; Ullman, S

    1998-01-01

    influence on survival related to mortality caused by infections. Diffuse central nervous system disease and myocarditis were related to increased SLE-related mortality, whereas photosensitivity predicted a decreased mortality. Non-fatal infections and thrombotic events predicted a decreased overall survival......In this Danish multicentre study, predictive clinical factors of mortality and survival were calculated for 513 patients with systemic lupus erythematosus (SLE), 122 of whom died within a mean observation period of 8.2 years equalling a mortality rate of 2.9% per year. Survival rates were 97%, 91...

  5. Italian multicentre study on microbial environmental contamination in dental clinics: a pilot study.

    Science.gov (United States)

    Pasquarella, Cesira; Veronesi, Licia; Castiglia, Paolo; Liguori, Giorgio; Montagna, Maria Teresa; Napoli, Christian; Rizzetto, Rolando; Torre, Ida; Masia, Maria Dolores; Di Onofrio, Valeria; Colucci, Maria Eugenia; Tinteri, Carola; Tanzi, Marialuisa

    2010-09-01

    The dental practice is associated with a high risk of infections, both for patients and healthcare operators, and the environment may play an important role in the transmission of infectious diseases. A microbiological environmental investigation was carried out in six dental clinics as a pilot study for a larger multicentre study that will be performed by the Italian SItI (Society of Hygiene, Preventive Medicine and Public Health) working group "Hygiene in Dentistry". Microbial contamination of water, air and surfaces was assessed in each clinic during the five working days of the week, before and during treatments. Air and surfaces were also examined at the end of the daily activity. A wide variation was found in microbial environmental contamination, both within the participating clinics and relative to the different sampling times. Microbial water contamination in Dental Unit Water Systems (DUWS) reached values of up to 26x10(4)cfu/mL (colony forming units per millilitre). P. aeruginosa was found in 33% of the sampled DUWS and Legionella spp. in 50%. A significant decrease in the Total Viable Count (TVC) was recorded during the activity. Microbial air contamination showed the highest levels during dental treatments and tended to decrease at the end of the working activity (p<0.05). Microbial buildup on surfaces increased significantly during the working hours. As these findings point out, research on microbial environmental contamination and the related risk factors in dental clinics should be expanded and should also be based on larger collections of data, in order to provide the essential knowledge aimed at targeted preventive interventions. Copyright 2010 Elsevier B.V. All rights reserved.

  6. [Multicentric hyaline vascular Castleman's disease. A POEMS type variant].

    Science.gov (United States)

    Gracia-Ramos, Abraham Edgar; Cruz-Domínguez, María del Pilar; Vera-Lastra, Olga Lidia

    2013-01-01

    Castleman's disease is an atypical lymphoproliferative disorder which may be compatible with paraneoplastic manifestations of POEMS syndrome. a 53 year old man with a history of type 2 diabetes, hypothyroidism and Addison's disease presented with numbness and weakness in limbs, dyspnea, skin hardening, Raynaud's phenomenon, weight loss and fatigue. A physical exam showed tachypnea, generalized cutaneous hyperpigmentation and skin hardening of extremities, muscle weakness, hypoesthesia and hyporeflexia. Laboratory showed hyperprolactinemia, low testosterone, hypothyroidism and Addison's disease. Electrophoresis of proteins showed polyclonal hypergammaglobulinemia. Somatosensory evoked potentials reported peripheral neuropathy and severe axonal polyneuropathy by electromyography. Chest X-rays showed bilateral reticular infiltrates and mediastinal widening. An echocardiogram displayed moderate pulmonary hypertension. Skin biopsy had no evidence of scleroderma. CT reported axillar, mediastinal and retroperitoneal nodes. The mediastinal lesion biopsy reported hyaline vascular Castleman's disease, multicentric variety. He was treated with rituximab. the case meet criteria for multicentric hyaline vascular Castleman's disease, POEMS variant, treated with rituximab.

  7. Managing acute alcohol withdrawal with Homoeopathy: A prospective, observational, multicentre exploratory study

    Directory of Open Access Journals (Sweden)

    Debadatta Nayak

    2014-01-01

    Full Text Available Background: Alcohol dependence is a common social problem which may be associated with other risk factors and co-morbidities. Abrupt cessation of alcohol intake may provoke an acute alcohol withdrawal phase with varying degrees of signs and symptoms. In conventional medical system, specific pharmacological interventions are used for management of Acute Alcohol Withdrawal (AAW. There exists a need to explore safe and holistic treatment of AAW. The present work reports the results of a prospective, observational, exploratory, multicentre trial (2008-2011 to assess the role of Homoeopathy in AAW. Materials and Methods: Individualised Homoeopathy was given to 112 patients reporting with AAW. The clinical assessment was done for 05 days using Clinical Institute Withdrawal Assessment Scale of Alcohol-Revised (CIWA-Ar. Post-withdrawal phase, quality of life of patients was assessed at end of 01 st , 03 rd and 06 th month using World Health Organisation quality of life (WHOQOL- BREF. Results and Analysis: There was a significant decrease in CIWA-Ar mean scores and increase in quality of life score (P < 0.001. The most common remedies used were Arsenicum album, Lycopodium clavatum, Belladonna, Nux vomica and Pulsatilla. Conclusion: The results of current observational pilot study suggest the promising use of Homoeopathy in the management of acute alcohol withdrawal. Further studies with large sample size and rigorous design are warranted.

  8. Screening prior to biological therapy in Crohn's disease: adherence to guidelines and prevalence of infections. Results from a multicentre retrospective study

    NARCIS (Netherlands)

    van der Have, Mike; Belderbos, Tim D. G.; Fidder, Herma H.; Leenders, Max; Dijkstra, Gerard; Peters, Charlotte P.; Eshuis, Emma J.; Ponsioen, Cyriel Y.; Siersema, Peter D.; van Oijen, Martijn G. H.; Oldenburg, Bas

    2014-01-01

    Screening for opportunistic infections prior to starting biological therapy in patients with inflammatory bowel disease is recommended. To assess adherence to screening for opportunistic infections prior to starting biological therapy in Crohn's disease patients and its yield. A multicentre

  9. Heterogeneous FDG-guided dose-escalation for locally advanced NSCLC (the NARLAL2 trial): Design and early dosimetric results of a randomized, multi-centre phase-III study

    DEFF Research Database (Denmark)

    Møller, Ditte Sloth; Nielsen, Tine Bjørn; Brink, Carsten

    2017-01-01

    Background and purpose: Local recurrence is frequent in locally advanced NSCLC and is primarily located in FDG-avid parts of tumour and lymph nodes. Aiming at improving local control without increasing toxicity, we designed a multi-centre phase-III trial delivering inhomogeneous dose-escalation d......Background and purpose: Local recurrence is frequent in locally advanced NSCLC and is primarily located in FDG-avid parts of tumour and lymph nodes. Aiming at improving local control without increasing toxicity, we designed a multi-centre phase-III trial delivering inhomogeneous dose...

  10. Synchronous Multicentric Giant Cell Tumour of Distal Radius and Sacrum with Pulmonary Metastases

    Directory of Open Access Journals (Sweden)

    Varun Sharma Tandra

    2015-01-01

    Full Text Available Giant cell tumour (GCT is an uncommon primary bone tumour, and its multicentric presentation is exceedingly rare. We report a case of a 45-year-old female who presented to us with GCT of left distal radius. On the skeletal survey, osteolytic lesion was noted in her right sacral ala. Biopsy confirmed both lesions as GCT. Pulmonary metastasis was also present. Resection-reconstruction arthroplasty for distal radius and thorough curettage and bone grafting of the sacral lesion were done. Multicentric GCT involving distal radius and sacrum with primary sacral involvement is not reported so far to our knowledge.

  11. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

    Full Text Available Abstract Background The International Multi-centre ADHD Genetics (IMAGE project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 unselected siblings. The aim was to describe and analyse questionnaire data and IQ measures from all probands and siblings. In particular, to investigate the influence of age, gender, family status (proband vs. sibling, informant, and centres on sample homogeneity in psychopathological measures. Methods Conners' Questionnaires, Strengths and Difficulties Questionnaires, and Wechsler Intelligence Scores were used to describe the phenotype of the sample. Data were analysed by use of robust statistical multi-way procedures. Results Besides main effects of age, gender, informant, and centre, there were considerable interaction effects on questionnaire data. The larger differences between probands and siblings at home than at school may reflect contrast effects in the parents. Furthermore, there were marked gender by status effects on the ADHD symptom ratings with girls scoring one standard deviation higher than boys in the proband sample but lower than boys in the siblings sample. The multi-centre design is another important source of heterogeneity, particularly in the interaction with the family status. To a large extent the centres differed from each other with regard to differences between proband and sibling scores. Conclusions When ADHD probands are diagnosed by use of fixed symptom counts, the severity of the disorder in the proband sample may markedly differ between boys and girls and across age, particularly in samples with a large age range. A multi-centre design carries the risk of considerable phenotypic differences between centres and, consequently, of additional heterogeneity of the sample even if standardized diagnostic procedures are

  12. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence.

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

    Abstract Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 unselected siblings. The aim was to describe and analyse questionnaire data and IQ measures from all probands and siblings. In particular, to investigate the influence of age, gender, family status (proband vs. sibling), informant, and centres on sample homogeneity in psychopathological measures. Methods Conners\\' Questionnaires, Strengths and Difficulties Questionnaires, and Wechsler Intelligence Scores were used to describe the phenotype of the sample. Data were analysed by use of robust statistical multi-way procedures. Results Besides main effects of age, gender, informant, and centre, there were considerable interaction effects on questionnaire data. The larger differences between probands and siblings at home than at school may reflect contrast effects in the parents. Furthermore, there were marked gender by status effects on the ADHD symptom ratings with girls scoring one standard deviation higher than boys in the proband sample but lower than boys in the siblings sample. The multi-centre design is another important source of heterogeneity, particularly in the interaction with the family status. To a large extent the centres differed from each other with regard to differences between proband and sibling scores. Conclusions When ADHD probands are diagnosed by use of fixed symptom counts, the severity of the disorder in the proband sample may markedly differ between boys and girls and across age, particularly in samples with a large age range. A multi-centre design carries the risk of considerable phenotypic differences between centres and, consequently, of additional heterogeneity of the sample even if standardized diagnostic procedures are used. These

  13. Authorship issues in multi-centre clinical trials: the importance of making an authorship contract.

    Science.gov (United States)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian; Vinther, Siri

    2015-02-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference to the original source.

  14. Colorectal cancer and its association with the metabolic syndrome: a Malaysian multi-centric case-control study.

    Science.gov (United States)

    Ulaganathan, V; Kandiah, M; Zalilah, M S; Faizal, J A; Fijeraid, H; Normayah, K; Gooi, B H; Othman, R

    2012-01-01

    Colorectal cancer (CRC) and the metabolic syndrome (MetS) are both on the rise in Malaysia. A multi-centric case-control study was conducted from December 2009 to January 2011 to determine any relationship between the two. Patients with confirmed CRC based on colonoscopy findings and cancer free controls from five local hospitals were assessed for MetS according to the International Diabetes Federation (IDF) definition. Each index case was matched for age, gender and ethnicity with two controls (140: 280). MetS among cases was highly prevalent (70.7%), especially among women (68.7%). MetS as an entity increased CRC risk by almost three fold independently (OR=2.61, 95%CI=1.53-4.47). In men MetS increased the risk of CRC by two fold (OR=2.01, 95%CI, 1.43-4.56), demonstrating an increasing trend in risk with the number of Mets components observed. This study provides evidence for a positive association between the metabolic syndrome and colorectal cancer. A prospective study on the Malaysian population is a high priority to confirm these findings.

  15. A Method for Teaching the Modeling of Manikins Suitable for Third-Person 3-D Virtual Worlds and Games

    Directory of Open Access Journals (Sweden)

    Nick V. Flor

    2012-08-01

    Full Text Available Virtual Worlds have the potential to transform the way people learn, work, and play. With the emerging fields of service science and design science, professors and students at universities are in a unique position to lead the research and development of innovative and value-adding virtual worlds. However, a key barrier in the development of virtual worlds—especially for business, technical, and non-artistic students—is the ability to model human figures in 3-D for use as avatars and automated characters in virtual worlds. There are no articles in either research or teaching journals which describe methods that non-artists can use to create 3-D human figures. This paper presents a repeatable and flexible method I have taught successfully to both artists and business students, which allows them to quickly model human-like figures (manikins that are sufficient for prototype purposes and that allows students and researchers alike to explore the development of new kinds of virtual worlds.

  16. EBV+ HHV-8+ Multicentric Castleman Disease With Plasmablastic Aggregates in an HIV+ Man: An Evolving Clinicopathologic Entity.

    Science.gov (United States)

    Shivane, Aditya; Pearce, Amy; Khatib, Nadia; Smith, Mark E F

    2018-06-01

    We report a case of EBV+ and HHV-8+ multicentric Castleman disease with plasmablastic aggregates in an HIV-positive individual. A 41-year-old man presented in early 2015 with fevers, sweats, weight loss, intractable itching, and on subsequent testing was found to be HIV positive. Investigations showed cervical lymphadenopathy and splenomegaly. He was treated for HIV and his symptoms resolved. His symptoms recurred in January 2016, and a provisional diagnosis of multicentric Castleman disease was entertained. The HHV-8 (human herpesvirus-8) and EBV (Epstein-Barr virus) viral load was elevated. A left supraclavicular lymph node core biopsy was performed, which showed features of multicentric Castleman disease with plasmablastic aggregates that are EBV (EBER) and HHV-8 positive. He responded well to rituximab treatment and remains well with no symptoms at recent follow-up.

  17. An Italian multicentre validation study of the coma recovery scale-revised.

    Science.gov (United States)

    Estraneo, A; Moretta, P; De Tanti, A; Gatta, G; Giacino, J T; Trojano, L

    2015-10-01

    Rate of misdiagnosis of disorders of consciousness (DoC) can be reduced by employing validated clinical diagnostic tools, such as the Coma Recovery Scale-Revised (CRS-R). An Italian version of the CRS-R has been recently developed, but its applicability across different clinical settings, and its concurrent validity and diagnostic sensitivity have not been estimated yet. To perform a multicentre validation study of the Italian version of the Coma Recovery Scale-Revised (CRS-R). Analysis of inter-rater reliability, concurrent validity and diagnostic sensitivity of the scale. One Intensive Care Unit, 8 Post-acute rehabilitation centres and 2 Long-term facilities Twenty-seven professionals (physicians, N.=11; psychologists, N.=5; physiotherapists, N.=3; speech therapists, N.=6; nurses, N.=2) from 11 Italian Centres. CRS-R and Disability Rating Scale (DRS) applied to 122 patients with clinical diagnosis of Vegetative State (VS) or Minimally Conscious State (MCS). CRS-R has good-to-excellent inter-rater reliability for all subscales, particularly for the communication subscale. The Italian version of the CRS-R showed a high sensitivity and specificity in detecting MCS with reference to clinical consensus diagnosis. The CRS-R showed good concurrent validity with the Disability Rating Scale, which had very low specificity with reference to clinical consensus diagnosis. The Italian version of the CRS-R is a valid scale for use from the sub-acute to chronic stages of DoC. It can be administered reliably by all members of the rehabilitation team with different specialties, levels of experience and settings. The present study promote use of the Italian version of the CRS-R to improve diagnosis of DoC patients, and plan tailored rehabilitation treatment.

  18. Blunt Cardiac Injury in the Severely Injured - A Retrospective Multicentre Study.

    Directory of Open Access Journals (Sweden)

    Marc Hanschen

    Full Text Available Blunt cardiac injury is a rare trauma entity. Here, we sought to evaluate the relevance and prognostic significance of blunt cardiac injury in severely injured patients.In a retrospective multicentre study, using data collected from 47,580 patients enrolled to TraumaRegister DGU (1993-2009, characteristics of trauma, prehospital / hospital trauma management, and outcome analysis were correlated to the severity of blunt cardiac injury. The severity of cardiac injury was assessed according to the abbreviated injury score (AIS score 1-6, the revised injury severity score (RISC allowed comparison of expected outcome with injury severity-dependent outcome. N = 1.090 had blunt cardiac trauma (AIS 1-6 (2.3% of patients.Predictors of blunt cardiac injury could be identified. Sternal fractures indicate a high risk of the presence of blunt cardiac injury (AIS 0 [control]: 3.0%; AIS 1: 19.3%; AIS 2-6: 19.1%. The overall mortality rate was 13.9%, minor cardiac injury (AIS 1 and severe cardiac injury (AIS 2-6 are associated with higher rates. Severe blunt cardiac injury (AIS 4 and AIS 5-6 is associated with a higher mortality (OR 2.79 and 4.89, respectively as compared to the predicted average mortality (OR 2.49 of the study collective.Multiple injured patients with blunt cardiac trauma are at high risk to be underestimated. Careful evaluation of trauma patients is able to predict the presence of blunt cardiac injury. The severity of blunt cardiac injury needs to be stratified according to the AIS score, as the patients' outcome is dependent on the severity of cardiac injury.

  19. A teaching intervention in a contouring dummy run improved target volume delineation in locally advanced non-small cell lung cancer: Reducing the interobserver variability in multicentre clinical studies.

    Science.gov (United States)

    Schimek-Jasch, Tanja; Troost, Esther G C; Rücker, Gerta; Prokic, Vesna; Avlar, Melanie; Duncker-Rohr, Viola; Mix, Michael; Doll, Christian; Grosu, Anca-Ligia; Nestle, Ursula

    2015-06-01

    Interobserver variability in the definition of target volumes (TVs) is a well-known confounding factor in (multicentre) clinical studies employing radiotherapy. Therefore, detailed contouring guidelines are provided in the prospective randomised multicentre PET-Plan (NCT00697333) clinical trial protocol. This trial compares strictly FDG-PET-based TV delineation with conventional TV delineation in patients with locally advanced non-small cell lung cancer (NSCLC). Despite detailed contouring guidelines, their interpretation by different radiation oncologists can vary considerably, leading to undesirable discrepancies in TV delineation. Considering this, as part of the PET-Plan study quality assurance (QA), a contouring dummy run (DR) consisting of two phases was performed to analyse the interobserver variability before and after teaching. In the first phase of the DR (DR1), radiation oncologists from 14 study centres were asked to delineate TVs as defined by the study protocol (gross TV, GTV; and two clinical TVs, CTV-A and CTV-B) in a test patient. A teaching session was held at a study group meeting, including a discussion of the results focussing on discordances in comparison to the per-protocol solution. Subsequently, the second phase of the DR (DR2) was performed in order to evaluate the impact of teaching. Teaching after DR1 resulted in a reduction of absolute TVs in DR2, as well as in better concordance of TVs. The Overall Kappa(κ) indices increased from 0.63 to 0.71 (GTV), 0.60 to 0.65 (CTV-A) and from 0.59 to 0.63 (CTV-B), demonstrating improvements in overall interobserver agreement. Contouring DRs and study group meetings as part of QA in multicentre clinical trials help to identify misinterpretations of per-protocol TV delineation. Teaching the correct interpretation of protocol contouring guidelines leads to a reduction in interobserver variability and to more consistent contouring, which should consequently improve the validity of the overall study

  20. A teaching intervention in a contouring dummy run improved target volume delineation in locally advanced non-small cell lung cancer. Reducing the interobserver variability in multicentre clinical studies

    International Nuclear Information System (INIS)

    Schimek-Jasch, Tanja; Prokic, Vesna; Doll, Christian; Grosu, Anca-Ligia; Nestle, Ursula; Troost, Esther G.C.; Ruecker, Gerta; Avlar, Melanie; Duncker-Rohr, Viola; Mix, Michael

    2015-01-01

    Interobserver variability in the definition of target volumes (TVs) is a well-known confounding factor in (multicentre) clinical studies employing radiotherapy. Therefore, detailed contouring guidelines are provided in the prospective randomised multicentre PET-Plan (NCT00697333) clinical trial protocol. This trial compares strictly FDG-PET-based TV delineation with conventional TV delineation in patients with locally advanced non-small cell lung cancer (NSCLC). Despite detailed contouring guidelines, their interpretation by different radiation oncologists can vary considerably, leading to undesirable discrepancies in TV delineation. Considering this, as part of the PET-Plan study quality assurance (QA), a contouring dummy run (DR) consisting of two phases was performed to analyse the interobserver variability before and after teaching. In the first phase of the DR (DR1), radiation oncologists from 14 study centres were asked to delineate TVs as defined by the study protocol (gross TV, GTV; and two clinical TVs, CTV-A and CTV-B) in a test patient. A teaching session was held at a study group meeting, including a discussion of the results focussing on discordances in comparison to the per-protocol solution. Subsequently, the second phase of the DR (DR2) was performed in order to evaluate the impact of teaching. Teaching after DR1 resulted in a reduction of absolute TVs in DR2, as well as in better concordance of TVs. The Overall Kappa(κ) indices increased from 0.63 to 0.71 (GTV), 0.60 to 0.65 (CTV-A) and from 0.59 to 0.63 (CTV-B), demonstrating improvements in overall interobserver agreement. Contouring DRs and study group meetings as part of QA in multicentre clinical trials help to identify misinterpretations of per-protocol TV delineation. Teaching the correct interpretation of protocol contouring guidelines leads to a reduction in interobserver variability and to more consistent contouring, which should consequently improve the validity of the overall study

  1. The effects of changes to the ERC resuscitation guidelines on no flow time and cardiopulmonary resuscitation quality: a randomised controlled study on manikins.

    Science.gov (United States)

    Jäntti, H; Kuisma, M; Uusaro, A

    2007-11-01

    The European Resuscitation Council (ERC) guidelines changed in 2005. We investigated the impact of these changes on no flow time and on the quality of cardiopulmonary resuscitation (CPR). Simulated cardiac arrest (CA) scenarios were managed randomly in manikins using ERC 2000 or 2005 guidelines. Pairs of paramedics/paramedic students treated 34 scenarios with 10min of continuous ventricular fibrillation. The rhythm was analysed and defibrillation shocks were delivered with a semi-automatic defibrillator, and breathing was assisted with a bag-valve-mask; no intravenous medication was given. Time factors related to human intervention and time factors related to device, rhythm analysis, charging and defibrillation were analysed for their contribution to no flow time (time without chest compression). Chest compression quality was also analysed. No flow time (mean+/-S.D.) was 66+/-3% of CA time with ERC 2000 and 32+/-4% with ERC 2005 guidelines (PERC 2000) versus 107+/-4s (ERC 2005) during 600-s scenarios (P=0.237). Device factor interventions took longer using ERC 2000 guidelines: 290+/-19s versus 92+/-15s (PERC 2005 guidelines (808+/-92s versus 458+/-90s, P<0.001), but the quality of CPR did not differ between the groups. The use of a single shock sequence with guidelines 2005 has decreased the no flow time during CPR when compared with guidelines 2000 with multiple shocks.

  2. Multicentric malignant gastrointestinal stromal tumor

    International Nuclear Information System (INIS)

    Shukla, Shailaja; Singh, Sanjeet K; Pujani, Mukta

    2009-01-01

    Malignant gastrointestinal stromal tumor (GIST) is a rare type of sarcoma that is found in the digestive system, most often in the wall of the stomach. Multiple GISTs are extremely rare and usually associated with type 1 neurofibromatosis and familial GIST. We report here a case of a 70-year-old woman who reported pain in the abdomen, loss of appetite, and weight loss for six months. Ultrasound examination showed a small bowel mass along with multiple peritoneal deposits and a mass within the liver. Barium studies were suggestive of a neoplastic pathology of the distal ileum. A differential diagnosis of adenocarcinoma/lymphoma with metastases was entertained. Perioperative findings showed two large growths arising from the jejunum and the distal ileum, along with multiple smaller nodules on the serosal surface and adjoining mesentery of the involved bowel segments. Segmental resection of the involved portions of the intestine was performed. Histopathological features were consistent with those of multicentric malignant GIST-not otherwise specified (GIST-NOS). Follow-up examination three months after surgery showed no evidence of recurrence. (author)

  3. The outcome of a multi-centre feasibility study of online adaptive radiotherapy for muscle-invasive bladder cancer TROG 10.01 BOLART

    International Nuclear Information System (INIS)

    Foroudi, Farshad; Pham, Daniel; Rolfo, Aldo; Bressel, Mathias; Tang, Colin I.; Tan, Alex; Turner, Sandra; Hruby, George; Williams, Stephen; Hayne, Dickon; Lehman, Margot; Skala, Marketa; Jose, Chakiath C.; Gogna, Kumar; Kron, Tomas

    2014-01-01

    Purpose: To assess whether online adaptive radiotherapy for bladder cancer is feasible across multiple Radiation Oncology departments using different imaging, delivery and recording technology. Materials and methods: A multi-centre feasibility study of online adaptive radiotherapy, using a choice of three “plan of the day”, was conducted at 12 departments. Patients with muscle-invasive bladder cancer were included. Departments were activated if part of the pilot study or after a site-credentialing visit. There was real time review of the first two cases from each department. Results: 54 patients were recruited, with 50 proceeding to radiotherapy. There were 43 males and 7 females with a mean age of 78 years. The tumour stages treated included T1 (1 patient), T2 (35), T3 (10) and T4 (4). One patient died of an unrelated cause during radiotherapy. The three adaptive plans were created before the 10th fraction in all cases. In 8 (16%) of the patients, a conventional plan using a ‘standard’ CTV to PTV margin of 1.5 cm was used for one or more fractions where the pre-treatment bladder CTV was larger than any of the three adaptive plans. The bladder CTV extended beyond the PTV on post treatment imaging in 9 (18%) of the 49 patients. Conclusions: From a technical perspective an online adaptive radiotherapy technique can be instituted in a multi-centre setting. However, without further bladder filling control or imaging, a CTV to PTV margin of 7 mm is insufficient

  4. HIV-associated multicentric Castleman’s disease

    Directory of Open Access Journals (Sweden)

    Fauzia de Fátima Naime

    2012-09-01

    Full Text Available Multicentric Castleman’s disease (MCD is a rare lymphoproliferative disorder. It is found with higher frequency in patients with HIV infection, with systemic symptoms and poor prognosis. We present the case of a 32-year old man with HIV disease, Kaposi’s sarcoma, lymphadenopathy, fever and hemolytic anemia. A diagnosis of Castleman’s disease is confirmed through biopsy and treatment is often based only on published case reports. Systemic treatments for MCD have included chemotherapy, anti-herpes virus, highly active antiretroviral therapy and, more recently, monoclonal antibodies against both IL6 and CD20.

  5. NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease

    NARCIS (Netherlands)

    Lawlor, B.; Kennelly, S.; O'Dwyer, S.; Cregg, F.; Walsh, C.; Coen, R.; Kenny, R.A.; Howard, R.; Murphy, C.; Adams, J.; Daly, L.; Segurado, R.; Gaynor, S.; Crawford, F.; Mullan, M.; Lucca, U.; Banzi, R.; Pasquier, F.; Breuilh, L.; Riepe, M.; Kalman, J.; Wallin, A.; Borjesson, A.; Molloy, W.; Tsolaki, M.; Olde Rikkert, M.G.M.

    2014-01-01

    INTRODUCTION: This study is a European multicentre, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer's disease (AD) in a phase III study that will run for a period of 82

  6. Evaluation of web-based annotation of ophthalmic images for multicentric clinical trials.

    Science.gov (United States)

    Chalam, K V; Jain, P; Shah, V A; Shah, Gaurav Y

    2006-06-01

    An Internet browser-based annotation system can be used to identify and describe features in digitalized retinal images, in multicentric clinical trials, in real time. In this web-based annotation system, the user employs a mouse to draw and create annotations on a transparent layer, that encapsulates the observations and interpretations of a specific image. Multiple annotation layers may be overlaid on a single image. These layers may correspond to annotations by different users on the same image or annotations of a temporal sequence of images of a disease process, over a period of time. In addition, geometrical properties of annotated figures may be computed and measured. The annotations are stored in a central repository database on a server, which can be retrieved by multiple users in real time. This system facilitates objective evaluation of digital images and comparison of double-blind readings of digital photographs, with an identifiable audit trail. Annotation of ophthalmic images allowed clinically feasible and useful interpretation to track properties of an area of fundus pathology. This provided an objective method to monitor properties of pathologies over time, an essential component of multicentric clinical trials. The annotation system also allowed users to view stereoscopic images that are stereo pairs. This web-based annotation system is useful and valuable in monitoring patient care, in multicentric clinical trials, telemedicine, teaching and routine clinical settings.

  7. Metronome improves compression and ventilation rates during CPR on a manikin in a randomized trial.

    Science.gov (United States)

    Kern, Karl B; Stickney, Ronald E; Gallison, Leanne; Smith, Robert E

    2010-02-01

    We hypothesized that a unique tock and voice metronome could prevent both suboptimal chest compression rates and hyperventilation. A prospective, randomized, parallel design study involving 34 pairs of paid firefighter/emergency medical technicians (EMTs) performing two-rescuer CPR using a Laerdal SkillReporter Resusci Anne manikin with and without metronome guidance was performed. Each CPR session consisted of 2 min of 30:2 CPR with an unsecured airway, then 4 min of CPR with a secured airway (continuous compressions at 100 min(-1) with 8-10 ventilations/min), repeated after the rescuers switched roles. The metronome provided "tock" prompts for compressions, transition prompts between compressions and ventilations, and a spoken "ventilate" prompt. During CPR with a bag/valve/mask the target compression rate of 90-110 min(-1) was achieved in 5/34 CPR sessions (15%) for the control group and 34/34 sessions (100%) for the metronome group (pmetronome or control group during CPR with a bag/valve/mask. During CPR with a bag/endotracheal tube, the target of both a compression rate of 90-110 min(-1) and a ventilation rate of 8-11 min(-1) was achieved in 3/34 CPR sessions (9%) for the control group and 33/34 sessions (97%) for the metronome group (pMetronome use with the secured airway scenario significantly decreased the incidence of over-ventilation (11/34 EMT pairs vs. 0/34 EMT pairs; pmetronome was effective at directing correct chest compression and ventilation rates both before and after intubation. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

  8. Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Dijkgraaf Marcel G

    2010-03-01

    Full Text Available Abstract Background Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. Methods/Design The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. Discussion To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease. Trial registration The Netherlands National Trial Register (NTR1303

  9. The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial

    DEFF Research Database (Denmark)

    Lindholt, J S; Gottschalksen, B; Johannesen, N

    2011-01-01

    To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study.......To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study....

  10. Imaging features of multicentric Castleman's disease in HIV infection

    International Nuclear Information System (INIS)

    Hillier, J.C.; Shaw, P.; Miller, R.F.; Cartledge, J.D.; Nelson, M.; Bower, M.; Francis, N.; Padley, S.P.

    2004-01-01

    AIM: To describe the computed tomography (CT) features of human immunodeficiency virus (HIV)-associated Castleman's disease. MATERIALS AND METHODS: Nine HIV-positive patients with biopsy-proven Castleman's disease were studied. Clinical and demographic data, CD4 count, histological diagnosis and human herpes type 8 (HHV8) serology or immunostaining results were recorded. CT images were reviewed independently by two radiologists. RESULTS: CT findings included splenomegaly (n=7) and peripheral lymph node enlargement (axillary n=8, inguinal n=4). All nodes displayed mild to avid enhancement after intravenous administration of contrast material. Hepatomegaly was evident in seven patients. Other features included abdominal (n=6) and mediastinal (n=5) lymph node enlargement and pulmonary abnormalities (n=4). Patterns of parenchymal abnormality included bronchovascular nodularity (n=2), consolidation (n=1) and pleural effusion (n=2). On histological examination eight patients (spleen n=3, lymph node n=9, lung n=1 bone marrow n=1) had the plasma cell variant and one had mixed hyaline-vascular/plasma cell variant. The majority had either positive immunostaining for HHV8 or positive serology (n=8). CONCLUSION: Common imaging features of multicentric Castleman's disease in HIV infection are hepatosplenomegaly and peripheral lymph node enlargement. Although these imaging features may suggest the diagnosis in the appropriate clinical context, they lack specificity and so biopsy is needed for diagnosis. In distinction from multicentric Castleman's disease in other populations the plasma cell variant is most commonly encountered, splenomegaly is a universal feature and there is a strong association with Kaposi's sarcoma

  11. Case report 375: Multicentric reticulohistiocytosis

    International Nuclear Information System (INIS)

    Scutellari, P.N.; Orzincolo, C.; Trotta, F.

    1986-01-01

    In summary, a case of multicentric reticulohistiocytosis in an 18-year-old girl is presented, with dramatic demonstration of the progressive lesions of the hands demonstrated in xeroradiographs. The association of nodules in the skin, particularly around the distal interphalangeal joints of the hands is stressed and the generally progressive nature of the disorder is emphasized and illustrated in this patient. The end result in most instances is that of an 'arthritis mutilans', with extensive deformities, particularly of the distal phalanges of the hands. The clinical, radiological and pathological aspects of the disorder are discussed and a review of the literature is included. The differential diagnosis, particularly including rheumatoid arthritis, is described in detail. The pathogenesis of the disorder is considered. (orig./SHA)

  12. Barriers and enablers to the use of high-fidelity patient simulation manikins in nurse education: an integrative review.

    Science.gov (United States)

    Al-Ghareeb, Amal Z; Cooper, Simon J

    2016-01-01

    This integrative review identified, critically appraised and synthesised the existing evidence on the barriers and enablers to using high-fidelity human patient simulator manikins (HPSMs) in undergraduate nursing education. In nursing education, specifically at the undergraduate level, a range of low to high-fidelity simulations have been used as teaching aids. However, nursing educators encounter challenges when introducing new teaching methods or technology, despite the prevalence of high-fidelity HPSMs in nursing education. An integrative review adapted a systematic approach. Medline, CINAHL plus, ERIC, PsychINFO, EMBASE, SCOPUS, Science Direct, Cochrane database, Joanna Brigge Institute, ProQuest, California Simulation Alliance, Simulation Innovative Recourses Center and the search engine Google Scholar were searched. Keywords were selected and specific inclusion/exclusion criteria were applied. The review included all research designs for papers published between 2000 and 2015 that identified the barriers and enablers to using high-fidelity HPSMs in undergraduate nursing education. Studies were appraised using the Critical Appraisal Skills Programme criteria. Thematic analysis was undertaken and emergent themes were extracted. Twenty-one studies were included in the review. These studies adopted quasi-experimental, prospective non-experimental and descriptive designs. Ten barriers were identified, including "lack of time," "fear of technology" and "workload issues." Seven enablers were identified, including "faculty training," "administrative support" and a "dedicated simulation coordinator." Barriers to simulation relate specifically to the complex technologies inherent in high-fidelity HPSMs approaches. Strategic approaches that support up-skilling and provide dedicated technological support may overcome these barriers. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. An Italian multicentre study on adult atopic dermatitis: persistent versus adult-onset disease.

    Science.gov (United States)

    Megna, Matteo; Patruno, Cataldo; Balato, Anna; Rongioletti, Franco; Stingeni, Luca; Balato, Nicola

    2017-08-01

    Atopic dermatitis (AD) is a chronic, recurrent, inflammatory skin disease which predominantly affects children. However, AD may persist until adulthood (persistent AD), or directly start in adults (adult-onset AD). AD often shows a non-flexural rash distribution, and atypical morphologic variants in adults and specific diagnostic criteria are lacking. Moreover, adult AD prevalence as well as detailed data which can characterize persistent vs adult-onset subtype are scant. The aim of this study was to investigate on the main features of adult AD particularly highlighting differences between persistent vs adult-onset form. An Italian multicentre observational study was conducted between April 2015-July 2016 through a study-specific digital database. 253 adult AD patients were enrolled. Familiar history of AD was negative in 81.0%. Erythemato-desquamative pattern was the most frequent clinical presentation (74.3%). Flexural surface of upper limbs was most commonly involved (47.8%), followed by eyelid/periocular area (37.9%), hands (37.2%), and neck (32%). Hypertension (7.1%) and thyroiditis (4.3%) were the most frequent comorbidities. A subgroup analysis between persistent (59.7%) vs adult-onset AD patients (40.3%) showed significant results only regarding AD severity (severe disease was more common in persistent group, p adult-onset disease), and comorbidities (hypertension was more frequent in adult-onset group, p Adult AD showed uncommon features such as significant association with negative AD family history and lacking of association with systemic comorbidities respect to general population. No significant differences among persistent vs adult-onset subgroup were registered except for hypertension, itch intensity, and disease severity.

  14. Prospective multicentre cohort study of heparin-induced thrombocytopenia in acute ischaemic stroke patients

    Science.gov (United States)

    Kawano, Hiroyuki; Yamamoto, Haruko; Miyata, Shigeki; Izumi, Manabu; Hirano, Teruyuki; Toratani, Naomi; Kakutani, Isami; Sheppard, Jo-Ann I; Warkentin, Theodore E; Kada, Akiko; Sato, Shoichiro; Okamoto, Sadahisa; Nagatsuka, Kazuyuki; Naritomi, Hiroaki; Toyoda, Kazunori; Uchino, Makoto; Minematsu, Kazuo

    2011-01-01

    Acute ischaemic stroke patients sometimes receive heparin for treatment and/or prophylaxis of thromboembolic complications. This study was designed to elucidate the incidence and clinical features of heparin-induced thrombocytopenia (HIT) in acute stroke patients treated with heparin. We conducted a prospective multicentre cohort study of 267 patients who were admitted to three stroke centres within 7 d after stroke onset. We examined clinical data until discharge and collected blood samples on days 1 and 14 of hospitalization to test anti-platelet factor 4/heparin antibodies (anti-PF4/H Abs) using an enzyme-linked immunosorbent assay (ELISA); platelet-activating antibodies were identified by serotonin-release assay (SRA). Patients with a 4Ts score ≥4 points, positive-ELISA, and positive-SRA were diagnosed as definite HIT. Heparin was administered to 172 patients (64·4%: heparin group). Anti-PF4/H Abs were detected by ELISA in 22 cases (12·8%) in the heparin group. Seven patients had 4Ts ≥ 4 points. Among them, three patients (1·7% overall) were also positive by both ELISA and SRA. National Institutes of Health Stroke Scale score on admission was high (range, 16–23) and in-hospital mortality was very high (66·7%) in definite HIT patients. In this study, the incidence of definite HIT in acute ischaemic stroke patients treated with heparin was 1·7% (95% confidence interval: 0·4–5·0). The clinical severity and outcome of definite HIT were unfavourable. PMID:21671895

  15. Tolerability of the capsaicin 8% patch following pretreatment with lidocaine or tramadol in patients with peripheral neuropathic pain: A multicentre, randomized, assessor-blinded study

    NARCIS (Netherlands)

    Jensen, T.S.; Hoye, K.; Fricova, J.; Vanelderen, P.J.L.; Ernault, E.; Siciliano, T.; Marques, S.

    2014-01-01

    BACKGROUND: Application of the capsaicin 8% patch is associated with treatment-related discomfort. Consequently, pretreatment for 60 min with anaesthetic cream is recommended; however, this may be uncomfortable and time consuming. METHODS: We conducted a multicentre, randomized (1:1),

  16. A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

    DEFF Research Database (Denmark)

    Rettenbacher, M; Andersen, A N; Garcia-Velasco, J A

    2015-01-01

    injection (n = 372) showed Bemfola yielding similar efficacy and safety profiles to Gonal-f. Women aged 20-38 years of age were randomized 2:1 to receive a single, daily, subcutaneous 150 IU dose of either Bemfola or Gonal-f. This study tested equivalence in the number of retrieved oocytes using a pre......Bemfola (follitropin alfa) (Finox AG, Switzerland), a new recombinant FSH, has a comparable pharmacological profile to that of Gonal-f (Merck Serono, Germany), the current standard for ovarian stimulation. A randomized, multi-centre, Phase 3 study in women undergoing IVF or intracytoplasmic sperm...

  17. Real-time feedback can improve infant manikin cardiopulmonary resuscitation by up to 79%--a randomised controlled trial.

    Science.gov (United States)

    Martin, Philip; Theobald, Peter; Kemp, Alison; Maguire, Sabine; Maconochie, Ian; Jones, Michael

    2013-08-01

    European and Advanced Paediatric Life Support training courses. Sixty-nine certified CPR providers. CPR providers were randomly allocated to a 'no-feedback' or 'feedback' group, performing two-thumb and two-finger chest compressions on a "physiological", instrumented resuscitation manikin. Baseline data was recorded without feedback, before chest compressions were repeated with one group receiving feedback. Indices were calculated that defined chest compression quality, based upon comparison of the chest wall displacement to the targets of four, internationally recommended parameters: chest compression depth, release force, chest compression rate and compression duty cycle. Baseline data were consistent with other studies, with <1% of chest compressions performed by providers simultaneously achieving the target of the four internationally recommended parameters. During the 'experimental' phase, 34 CPR providers benefitted from the provision of 'real-time' feedback which, on analysis, coincided with a statistical improvement in compression rate, depth and duty cycle quality across both compression techniques (all measures: p<0.001). Feedback enabled providers to simultaneously achieve the four targets in 75% (two-finger) and 80% (two-thumb) of chest compressions. Real-time feedback produced a dramatic increase in the quality of chest compression (i.e. from <1% to 75-80%). If these results transfer to a clinical scenario this technology could, for the first time, support providers in consistently performing accurate chest compressions during infant CPR and thus potentially improving clinical outcomes. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  18. EANM/EARL harmonization strategies in PET quantification: from daily practice to multicentre oncological studies

    Energy Technology Data Exchange (ETDEWEB)

    Aide, Nicolas [University Hospital, Nuclear Medicine Department, Caen (France); Caen University, Inserm U1086 ANTICIPE, Caen (France); Lasnon, Charline [Caen University, Inserm U1086 ANTICIPE, Caen (France); Francois Baclesse Cancer Centre, Nuclear Medicine Department, Caen (France); Veit-Haibach, Patrick [University Hospital Zurich, Department of Nuclear Medicine and Department of Diagnostic and Interventional Radiology, Zurich (Switzerland); University Health Network, University of Toronto, Joint Department Medical Imaging, Toronto (Canada); Sera, Terez [University of Szeged, Nuclear Medicine Department, Szeged (Hungary); Sattler, Bernhard [University Hospital of Leipzig, Department of Nuclear Medicine, Leipzig (Germany); Boellaard, Ronald [University of Groningen, University Medical Center Groningen, Department of Nuclear Medicine and Molecular Imaging, Groningen (Netherlands); VU University Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam (Netherlands)

    2017-08-15

    Quantitative positron emission tomography/computed tomography (PET/CT) can be used as diagnostic or prognostic tools (i.e. single measurement) or for therapy monitoring (i.e. longitudinal studies) in multicentre studies. Use of quantitative parameters, such as standardized uptake values (SUVs), metabolic active tumor volumes (MATVs) or total lesion glycolysis (TLG), in a multicenter setting requires that these parameters be comparable among patients and sites, regardless of the PET/CT system used. This review describes the motivations and the methodologies for quantitative PET/CT performance harmonization with emphasis on the EANM Research Ltd. (EARL) Fluorodeoxyglucose (FDG) PET/CT accreditation program, one of the international harmonization programs aiming at using FDG PET as a quantitative imaging biomarker. In addition, future accreditation initiatives will be discussed. The validation of the EARL accreditation program to harmonize SUVs and MATVs is described in a wide range of tumor types, with focus on therapy assessment using either the European Organization for Research and Treatment of Cancer (EORTC) criteria or PET Evaluation Response Criteria in Solid Tumors (PERCIST), as well as liver-based scales such as the Deauville score. Finally, also presented in this paper are the results from a survey across 51 EARL-accredited centers reporting how the program was implemented and its impact on daily routine and in clinical trials, harmonization of new metrics such as MATV and heterogeneity features. (orig.)

  19. Comparison between repaglinide and glipizide in Type 2 diabetes mellitus: a 1-year multicentre study

    DEFF Research Database (Denmark)

    Madsbad, Sten; Kilhovd, B; Lager, I

    2001-01-01

    AIMS: To evaluate the long-term effectiveness and safety of repaglinide, a novel prandial glucose regulator, in comparison with glipizide in the treatment of patients with Type 2 diabetes. METHODS: Diet or tablet-treated patients with Type 2 diabetes (n = 256; age 40-75 years, body mass index (BMI...... with Type 2 diabetes, and is better than glipizide in controlling HbA1c and FBG levels, overall, and in OHA-naive patients.......) 20-35 kg/m2, HbA1c 4.2-12.8%), without signs of severe microvascular or macrovascular complications, were included in this double-blind, multicentre, parallel-group comparative trial. Patients were randomized at a 2:1 ratio to repaglinide, 1-4 mg at mealtimes, or glipizide, 5-15 mg daily. RESULTS...

  20. [Establishment and Management of Multicentral Collection Bio-sample Banks of Malignant Tumors from Digestive System].

    Science.gov (United States)

    Shen, Si; Shen, Junwei; Zhu, Liang; Wu, Chaoqun; Li, Dongliang; Yu, Hongyu; Qiu, Yuanyuan; Zhou, Yi

    2015-11-01

    To establish and manage of multicentral collection bio-sample banks of malignant tumors from digestive system, the paper designed a multicentral management system, established the standard operation procedures (SOPs) and leaded ten hospitals nationwide to collect tumor samples. The biobank has been established for half a year, and has collected 695 samples from patients with digestive system malignant tumor. The clinical data is full and complete, labeled in a unified way and classified to be managed. The clinical and molecular biology researches were based on the biobank, and obtained achievements. The biobank provides a research platform for malignant tumor of digestive system from different regions and of different types.

  1. Proposal for the standardisation of multi-centre trials in nuclear medicine imaging

    DEFF Research Database (Denmark)

    Dickson, John Caddell; Tossici-Bolt, Livia; Sera, Terez

    2012-01-01

    Multi-centre trials are an important part of proving the efficacy of procedures, drugs and interventions. Imaging components in such trials are becoming increasingly common; however, without sufficient control measures the usefulness of these data can be compromised. This paper describes a framew...

  2. I-MOVE multi-centre case control study 2010-11: overall and stratified estimates of influenza vaccine effectiveness in Europe.

    Directory of Open Access Journals (Sweden)

    Esther Kissling

    Full Text Available BACKGROUND: In the third season of I-MOVE (Influenza Monitoring Vaccine Effectiveness in Europe, we undertook a multicentre case-control study based on sentinel practitioner surveillance networks in eight European Union (EU member states to estimate 2010/11 influenza vaccine effectiveness (VE against medically-attended influenza-like illness (ILI laboratory-confirmed as influenza. METHODS: Using systematic sampling, practitioners swabbed ILI/ARI patients within seven days of symptom onset. We compared influenza-positive to influenza laboratory-negative patients among those meeting the EU ILI case definition. A valid vaccination corresponded to > 14 days between receiving a dose of vaccine and symptom onset. We used multiple imputation with chained equations to estimate missing values. Using logistic regression with study as fixed effect we calculated influenza VE adjusting for potential confounders. We estimated influenza VE overall, by influenza type, age group and among the target group for vaccination. RESULTS: We included 2019 cases and 2391 controls in the analysis. Adjusted VE was 52% (95% CI 30-67 overall (N = 4410, 55% (95% CI 29-72 against A(H1N1 and 50% (95% CI 14-71 against influenza B. Adjusted VE against all influenza subtypes was 66% (95% CI 15-86, 41% (95% CI -3-66 and 60% (95% CI 17-81 among those aged 0-14, 15-59 and ≥60 respectively. Among target groups for vaccination (N = 1004, VE was 56% (95% CI 34-71 overall, 59% (95% CI 32-75 against A(H1N1 and 63% (95% CI 31-81 against influenza B. CONCLUSIONS: Results suggest moderate protection from 2010-11 trivalent influenza vaccines against medically-attended ILI laboratory-confirmed as influenza across Europe. Adjusted and stratified influenza VE estimates are possible with the large sample size of this multi-centre case-control. I-MOVE shows how a network can provide precise summary VE measures across Europe.

  3. Nocturnal emergency department visits, duration of symptoms and risk of hospitalisation among adults with asthma exacerbations: a multicentre observational study.

    Science.gov (United States)

    Yasuda, Hideto; Hagiwara, Yusuke; Watase, Hiroko; Hasegawa, Kohei

    2016-08-12

    We sought to compare the characteristics of patients with asthma presenting to the emergency department (ED) during the night-time with those of patients presenting at other times of the day, and to determine whether the time of ED presentation is associated with the risk of hospitalisation. A multicentre chart review study of 23 EDs across Japan. Patients aged 18-54 years with a history of physician-diagnosed asthma, presented to the ED between January 2009 and December 2011 OUTCOME MEASURES: The outcome of interest was hospitalisation, including admissions to an observation unit, inpatient unit and intensive care unit. Among the 1354 patients (30.1% in the night-time group vs 69.9% in the other time group) included in this study, the median age was 34 years and ∼40% were male. Overall 145 patients (10.7%) were hospitalised. Patients in the night-time group were more likely to have a shorter duration of symptoms (≤3 hours) before ED presentation than those in the other time group (25.9% in night-time vs 13.4% in other times; pdifferences in respiratory rate, initial peak expiratory flow or ED asthma treatment between the two groups (p>0.05). Similarly, the risk of hospitalisation did not differ between the two groups (11.3% in night-time vs 10.5% in other times; p=0.65). In a multivariable model adjusting for potential confounders, the risk of hospitalisation in the night-time group was not statistically different from the other time group (OR, 1.10; 95% CI 0.74 to 1.61; p=0.63). This multicentre study in Japan demonstrated no significant difference in the risk of hospitalisations according to the time of ED presentation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial.

    Science.gov (United States)

    Treweek, Shaun; Wilkie, Erna; Craigie, Angela M; Caswell, Stephen; Thompson, Joyce; Steele, Robert J C; Stead, Martine; Anderson, Annie S

    2013-12-18

    Recruiting participants to multicentre, community-based trials is a challenge. This case study describes how this challenge was met for the BeWEL trial, which evaluated the impact of a diet and physical activity intervention on body weight in people who had had pre-cancerous bowel polyps. The BeWEL trial was a community-based trial, involving centres linked to the Scottish National Health Service (NHS) colorectal cancer screening programme. BeWEL had a recruitment target of 316 and its primary recruitment route was the colonoscopy clinics of the Scottish Bowel Screening Programme. BeWEL exceeded its recruitment target but needed a 6-month no-cost extension from the funder to achieve this. The major causes of delay were lower consent rates (49% as opposed to 70% estimated from earlier work), the time taken for NHS research and development department approvals and the inclusion of two additional sites to increase recruitment, for which there were substantial bureaucratic delays. A range of specific interventions to increase recruitment, for example, telephone reminders and a shorter participant information leaflet, helped to increase the proportion of eligible individuals consenting and being randomized. Recruitment to multicentre trials is a challenge but can be successfully achieved with a committed team. In a UK context, NHS research and development approval can be a substantial source of delay. Investigators should be cautious when estimating consent rates. If consent rates are less than expected, qualitative analysis might be beneficial, to try and identify the reason. Finally, investigators should select trial sites on the basis of a formal assessment of a site's past performance and the likelihood of success in the trial being planned. Current Controlled Trials ISRCTN53033856.

  5. Advantages of the modified double ring areolar incision over the traditional areolar incision in multicentric breast fibroadenoma surgery.

    Science.gov (United States)

    Zhang, Mingliang; Shen, Gongjin; Zhang, Song; Cui, Zhen; Qian, Jun

    2017-09-01

    This study was conducted to investigate the clinical advantages of modified double ring areola incision (MDRAI) compared to ordinary areola incision (OAI) in multicentric breast fibroadenoma in women. Sixty cases of multicentric benign breast tumor were recruited from the First Affiliated Hospital of Bengbu Medical College from January to December 2016. The cases were divided into two groups according to surgical approach: MDRAI (n = 20) and OAI (n = 40). The operation duration, intraoperative blood loss, drainage time, and postoperative recurrence rate in the first six months were compared. The mean age and tumor locations were not statistically different between the groups (P > 0.05). However, more lesions and larger tumor diameter were found in the MDRAI group than in the OAI group, with statistical difference (P  0.05). However, the intraoperative blood loss was statistically different between the two groups (P < 0.05). All 60 cases received six months of follow-up. Eight recurrent cases were found in the OAI group, but none in the MDRAI group. The recurrence rate was significantly different (χ 2  = 4.62, P < 0.05). Compared with OAI, MDRAI offers greater advantages in the aspects of blood loss and recurrence for the treatment of breast benign tumor, especially for multicentric larger lesions. © 2017 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

  6. Frequency of participation of 8-12-year-old children with cerebral palsy: a multi-centre cross-sectional European study

    DEFF Research Database (Denmark)

    Michelsen, Susan I; Flachs, Esben M; Uldall, Peter

    2008-01-01

    might influence participation. We undertook a multi-centre, population-based study in children with and without cerebral palsy. Working from the Life-H instrument, we developed a questionnaire to capture frequency of participation in 8-12-year-old children. In nine regions of seven European countries......, parents of 813 children with cerebral palsy and 2939 children from the general populations completed the questionnaire. Frequency of participation for each question was dichotomised about the median; multivariable logistic regressions were carried out. In the general population, frequency of participation...... varied between countries. Children with cerebral palsy participated less frequently in many but not all areas of everyday life, compared with children from the general population. There was regional variation in the domains with reduced participation and in the magnitude of the differences. We discuss...

  7. Simulation Use in Paramedic Education Research (SUPER): A Descriptive Study.

    Science.gov (United States)

    McKenna, Kim D; Carhart, Elliot; Bercher, Daniel; Spain, Andrew; Todaro, John; Freel, Joann

    2015-01-01

    The purpose of this research was to characterize the use of simulation in initial paramedic education programs in order assist stakeholders' efforts to target educational initiatives and resources. This group sought to provide a snapshot of what simulation resources programs have or have access to and how they are used; faculty perceptions about simulation; whether program characteristics, resources, or faculty training influence simulation use; and if simulation resources are uniform for patients of all ages. This was a cross-sectional census survey of paramedic programs that were accredited or had a Letter of Review from the Committee on Accreditation of Educational Programs for the EMS Professions at the time of the study. The data were analyzed using descriptive statistics and chi-square analyses. Of the 638 surveys sent, 389 valid responses (61%) were analyzed. Paramedic programs reported they have or have access to a wide range of simulation resources (task trainers [100%], simple manikins [100%], intermediate manikins [99%], advanced/fully programmable manikins [91%], live simulated patients [83%], computer-based [71%], and virtual reality [19%]); however, they do not consistently use them, particularly advanced (71%), live simulated patients (66%), computer-based (games, scenarios) (31%), and virtual reality (4%). Simulation equipment (of any type) reportedly sits idle and unused in (31%) of programs. Lack of training was cited as the most common reason. Personnel support specific to simulation was available in 44% of programs. Programs reported using simulation to replace skills more frequently than to replace field or clinical hours. Simulation goals included assessment, critical thinking, and problem-solving most frequently, and patient and crew safety least often. Programs using advanced manikins report manufacturers as their primary means of training (87%) and that 19% of faculty had no training specific to those manikins. Many (78%) respondents felt

  8. Precision of 3.0 Tesla quantitative magnetic resonance imaging of cartilage morphology in a multicentre clinical trial.

    Science.gov (United States)

    Eckstein, F; Buck, R J; Burstein, D; Charles, H C; Crim, J; Hudelmaier, M; Hunter, D J; Hutchins, G; Jackson, C; Kraus, V Byers; Lane, N E; Link, T M; Majumdar, L S; Mazzuca, S; Prasad, P V; Schnitzer, T J; Taljanovic, M S; Vaz, A; Wyman, B; Le Graverand, M-P Hellio

    2008-12-01

    Quantitative MRI (qMRI) of cartilage morphology is a promising tool for disease-modifying osteoarthritis drug (DMOAD) development. Recent studies at single sites have indicated that measurements at 3.0 Tesla (T) are more reproducible (precise) than those at 1.5 T. Precision errors and stability in multicentre studies with imaging equipment from various vendors have, however, not yet been evaluated. A total of 158 female participants (97 Kellgren and Lawrence grade (KLG) 0, 31 KLG 2 and 30 KLG 3) were imaged at 7 clinical centres using Siemens Magnetom Trio and GE Signa Excite magnets. Double oblique coronal acquisitions were obtained at baseline and at 3 months, using water excitation spoiled gradient echo sequences (1.0x0.31x0.31 mm3 resolution). Segmentation of femorotibial cartilage morphology was performed using proprietary software (Chondrometrics GmbH, Ainring, Germany). The precision error (root mean square coefficient of variation (RMS CV)%) for cartilage thickness/volume measurements ranged from 2.1%/2.4% (medial tibia) to 2.9%/3.3% (lateral weight-bearing femoral condyle) across all participants. No significant differences in precision errors were observed between KLGs, imaging sites, or scanner manufacturers/types. Mean differences between baseline and 3 months ranged from <0.1% (non-significant) in the medial to 0.94% (p<0.01) in the lateral femorotibial compartment, and were 0.33% (p<0.02) for the total femorotibial subchondral bone area. qMRI performed at 3.0 T provides highly reproducible measurements of cartilage morphology in multicentre clinical trials with equipment from different vendors. The technology thus appears sufficiently robust to be recommended for large-scale multicentre trials.

  9. HPV and cofactors for invasive cervical cancer in Morocco: a multicentre case-control study.

    Science.gov (United States)

    Berraho, Mohamed; Amarti-Riffi, Afaf; El-Mzibri, Mohammed; Bezad, Rachid; Benjaafar, Noureddine; Benideer, Abdelatif; Matar, Noureddine; Qmichou, Zinab; Abda, Naima; Attaleb, Mohammed; Znati, Kaoutar; El Fatemi, Hind; Bendahhou, Karima; Obtel, Majdouline; Filali Adib, Abdelhai; Mathoulin-Pelissier, Simone; Nejjari, Chakib

    2017-06-20

    Limited national information is available in Morocco on the prevalence and distribution of HPV-sub-types of cervical cancer and the role of other risk factors. The aim was to determine the frequency of HPV-sub-types of cervical cancer in Morocco and investigate risk factors for this disease. Between November 2009 and April 2012 a multicentre case-control study was carried out. A total of 144 cases of cervical cancer and 288 age-matched controls were included. Odds-ratios and corresponding confidence-intervals were computed by conditional logistic regression models. Current HPV infection was detected in 92.5% of cases and 13.9% of controls. HPV16 was the most common type for both cases and controls. Very strong associations between HPV-sub-types and cervical cancer were observed: total-HPV (OR = 39), HPV16 (OR = 49), HPV18 (OR = 31), and multiple infections (OR = 13). Education, high parity, sexual intercourse during menstruation, history of sexually transmitted infections, and husband's multiple sexual partners were also significantly associated with cervical cancer in the multivariate analysis. Our results could be used to establish a primary prevention program and to prioritize limited screening to women who have specific characteristics that may put them at an increased risk of cervical cancer.

  10. Performance of mechanical ventilators at the patient's home: a multicentre quality control study.

    Science.gov (United States)

    Farré, R; Navajas, D; Prats, E; Marti, S; Guell, R; Montserrat, J M; Tebe, C; Escarrabill, J

    2006-05-01

    Quality control procedures vary considerably among the providers of equipment for home mechanical ventilation (HMV). A multicentre quality control survey of HMV was performed at the home of 300 patients included in the HMV programmes of four hospitals in Barcelona. It consisted of three steps: (1) the prescribed ventilation settings, the actual settings in the ventilator control panel, and the actual performance of the ventilator measured at home were compared; (2) the different ventilator alarms were tested; and (3) the effect of differences between the prescribed settings and the actual performance of the ventilator on non-programmed readmissions of the patient was determined. Considerable differences were found between actual, set, and prescribed values of ventilator variables; these differences were similar in volume and pressure preset ventilators. The percentage of patients with a discrepancy between the prescribed and actual measured main ventilator variable (minute ventilation or inspiratory pressure) of more than 20% and 30% was 13% and 4%, respectively. The number of ventilators with built in alarms for power off, disconnection, or obstruction was 225, 280 and 157, respectively. These alarms did not work in two (0.9%), 52 (18.6%) and eight (5.1%) ventilators, respectively. The number of non-programmed hospital readmissions in the year before the study did not correlate with the index of ventilator error. This study illustrates the current limitations of the quality control of HMV and suggests that improvements should be made to ensure adequate ventilator settings and correct ventilator performance and ventilator alarm operation.

  11. Prevalence, risk factors and associated adverse pregnancy outcomes of anaemia in Chinese pregnant women: a multicentre retrospective study.

    Science.gov (United States)

    Lin, Li; Wei, Yumei; Zhu, Weiwei; Wang, Chen; Su, Rina; Feng, Hui; Yang, Huixia

    2018-04-23

    Anaemia in pregnant women is a public health problem, especially in developing countries. The aim of this study was to assess the prevalence and related risk factors of anaemia during pregnancy in a large multicentre retrospective study (n = 44,002) and to determine the adverse pregnancy outcomes in women with or without anaemia. The study is a secondary data analysis of a retrospective study named "Gestational diabetes mellitus Prevalence Survey (GPS) study in China". Structured questionnaires were used to collect socio-demographic characteristics, haemoglobin levels and pregnancy outcomes from all the participants. Anaemia in pregnancy is defined as haemoglobin anaemia and associated adverse pregnancy outcomes. The overall prevalence of anaemia was 23.5%. Maternal anaemia was significantly associated with maternal age ≥ 35 years (AOR = 1.386), family per capita monthly incomepregnancy BMI pregnancy outcomes, including GDM, polyhydramnios, preterm birth, low birth weight (anaemia than those without. The results indicated that anaemia continues to be a severe health problem among pregnant women in China. Anaemia is associated with adverse pregnancy outcomes. Pregnant women should receive routine antenatal care and be given selective iron supplementation when appropriate.

  12. A double-blind comparative multicentre study of remoxipride and haloperidol in schizophrenia.

    Science.gov (United States)

    Lindström, L H; Wieselgren, I M; Struwe, G; Kristjansson, E; Akselson, S; Arthur, H; Andersen, T; Lindgren, S; Norman, O; Naimell, L

    1990-01-01

    In a double-blind multicentre study of parallel group design the efficacy and safety of remoxipride and haloperidol were compared in a total of 96 patients with acute episodes of schizophrenic or schizophreniform disorder according to DSM-III. There were 48 patients in each treatment group; 27 men and 21 women in the remoxipride group, 33 men and 15 women in the haloperidol group. The median duration of illness was 7 years in both groups. The mean daily dose was 437 mg for remoxipride and 10.6 mg for haloperidol during the last week of treatment. No statistically significant differences in total BPRS scores were found between remoxipride and haloperidol. The median total BPRS scores at the start of active treatment were 26 in the remoxipride and 27 in the haloperidol group; these were reduced to 16 and 12.5, respectively, at the last rating. According to Clinical Global Impression (CGI), 43% of patients in the remoxipride group and 68% of those in the haloperidol group improved much or very much during treatment. This difference was not statistically significant. Treatment-emergent extrapyramidal side effects such as akathisia, tremor, and rigidity occurred significantly more frequently in the haloperidol group; this group also made more frequent use of anticholinergic drugs. Neither of the trial drugs seriously affected laboratory or cardiovascular variables. It is concluded that remoxipride has an antipsychotic effect in a dose range of 150-600 mg per day comparable to that of haloperidol in doses up to 20 mg per day but with fewer extrapyramidal side effects.

  13. Teaching basic life support: a prospective randomized study on low-cost training strategies in secondary schools.

    Science.gov (United States)

    Van Raemdonck, Veerle; Monsieurs, Koenraad G; Aerenhouts, Dirk; De Martelaer, Kristine

    2014-08-01

    Cardiopulmonary resuscitation (CPR) training at school is recommended. Limited school resources prevent implementation. The learning efficacy of low-cost training strategies is unknown. To evaluate the efficacy of different CPR learning strategies using low-cost didactic tools. Children (n=593, 15-16 years) were randomized to four training conditions: (1) manikin+teacher instruction (control group), (2) manikin+video instruction, (3) foam dice+plastic bag+peer training+teacher instruction, and (4) foam dice+plastic bag+peer training+video instruction. After a 50 min training, a 3 min CPR test on a manikin was performed using SkillReporting Software (Laerdal, Norway), and repeated after 6 months. The data of children without previous CPR training were analysed. Analysis of variance and the χ-test assessed differences between groups. Complete data sets were available for 165 pupils. Initially, group 3 scored lower on the mean ventilation volume (Pbasics of CPR can be taught with alternative equipment if manikins are not available.

  14. Dispatcher-assisted compression-only cardiopulmonary resuscitation provides best quality cardiopulmonary resuscitation by laypersons: A randomised controlled single-blinded manikin trial.

    Science.gov (United States)

    Spelten, Oliver; Warnecke, Tobias; Wetsch, Wolfgang A; Schier, Robert; Böttiger, Bernd W; Hinkelbein, Jochen

    2016-08-01

    High-quality cardiopulmonary resuscitation (CPR) by laypersons is a key determinant of both outcome and survival for out-of-hospital cardiac arrest. Dispatcher-assisted CPR (telephone-CPR, T-CPR) increases the frequency and correctness of bystander-CPR but results in prolonged time to first chest compressions. However, it remains unclear whether instructions for rescue ventilation and/or chest compressions should be recommended for dispatcher-assisted CPR. The aim of this study was to evaluate both principles of T-CPR with respect to CPR quality. Randomised controlled single-blinded manikin trial. University Hospital of Cologne, Germany, 1 July 2012 to 30 September 2012. Sixty laypersons between 18 and 65 years. Medically educated individuals, medical professionals and pregnant women were excluded. Participants were asked to resuscitate a manikin and were randomised into three groups: not dispatcher-assisted (uninstructed) CPR (group 1; U-CPR; n = 20), dispatcher-assisted compression-only CPR (group 2; DACO-CPR; n = 19) and full dispatcher-assisted CPR with rescue ventilation (group 3; DAF-CPR; n = 19). Specific parameters of CPR quality [i.e. no-flow-time (NFT) as well as compression and ventilation parameters] were analysed. To compare different groups we used Student's t test and P less than 0.05 was considered significant. Initial NFT was lowest in the DACO-CPR group (mean 21.3 ± 14.4%), followed by dispatcher-assisted full CPR (mean 49.1 ± 8.5%) and by unassisted CPR (mean 55.0 ± 12.9%). Initial NFT covering the time of instruction was lower in DACO-CPR (12.1 ± 5.4%) as compared to dispatcher-assisted full CPR (20.7 ± 8.1%). Compression depth was similar in all three groups: 40.6 ± 13.0 mm (unassisted CPR), 41.0 ± 12.2 mm (DACO-CPR) and 38.8 ± 15.8 mm (dispatcher-assisted full CPR). Average compression frequency was highest in the DACO-CPR group (65.2 ± 22.4 min) compared with the unassisted CPR

  15. Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies

    Directory of Open Access Journals (Sweden)

    Marent Marta

    2010-11-01

    Full Text Available Abstract Background With an ever-increasing elderly population, orthopaedic surgeons are faced with treating a high number of fragility fractures. Biomechanical tests have demonstrated the potential role of osteoporosis in the increased risk of fracture fixation complications, yet this has not been sufficiently proven in clinical practice. Based on this knowledge, two clinical studies were designed to investigate the influence of local bone quality on the occurrence of complications in elderly patients with distal radius and proximal humerus fractures treated by open reduction and internal fixation. Methods/Design The studies were planned using a prospective multicentre open cohort design and included patients between 50 and 90 years of age. Distal radius and proximal humerus fractures were treated with locking compression 2.4 mm and proximal humerus internal locking plates, respectively. Follow-up examinations were planned for 6 weeks, 3 and 12 months as well as a telephone interview at 6 months. The primary outcome focuses on the occurrence of at least one local bone quality related complication. Local bone quality is determined by measuring bone mineral density and bone mineral content at the contralateral radius. Primary complications are categorised according to predefined factors directly related to the bone/fracture or the implant/surgical technique. Secondary outcomes include the documentation of soft tissue/wound or general/systemic complications, clinical assessment of range of motion, and patient-rated evaluations of upper limb function and quality of life using both objective and subjective measures. Discussion The prospective multicentre open cohort studies will determine the value of local bone quality as measured by bone mineral density and content, and compare the quality of local bone of patients who experience a complication (cases following surgery with that of patients who do not (controls. These measurements are novel and

  16. Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study

    DEFF Research Database (Denmark)

    Haaverstad, Rune; Vitale, Nicola; Karevold, Asbjørn

    2006-01-01

    OBJECTIVE: The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis. METHODS: From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received...... an aortic advantage valve prosthesis. Complete cumulative follow-up was 242.7 patient-years (maximum 3.2; mean 1.6 years). Postoperatively, patients underwent early (within 30 days) and 1 year transthoracic echocardiography. RESULTS: 30 day mortality was 2.4% (n = 4). Kaplan-Meier estimates of freedom from...... echocardiography. CONCLUSIONS: Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use....

  17. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  18. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Rengerink, Katrien Oude; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    Objective To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an

  19. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, L.M.; Bloemenkamp, K.W.; Franssen, M.T.; Papatsonis, D.N.; Hajenius, P.J.; Hollmann, M.W.; Woiski, M.D.; Porath, M.; Berg, H.J. van den; Beek, E. van; Borchert, O.W.; Schuitemaker, N.; Sikkema, J.M.; Kuipers, A.H.; Logtenberg, S.L.; Salm, P.C. van der; Oude Rengerink, K.; Lopriore, E.; Akker-van Marle, M.E. van den; Cessie, S. le; Lith, J.M. van; Struys, M.M.; Mol, B.W.; Dahan, A; Middeldorp, J.M.

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  20. Computational modeling of particle transport and distribution emitted from a Laserjet printer in a ventilated room with different ventilation configurations

    International Nuclear Information System (INIS)

    Ansaripour, Mehrzad; Abdolzadeh, Morteza; Sargazizadeh, Saleh

    2016-01-01

    Highlights: • The distribution of emitted particles form a laserjet printer was studied in the breathing zone. • Effects of different ventilation configurations on the breathing zone concentration were investigated. • Mixing ventilation system has a low mean particle concentration in the breathing zone. - Abstract: In the present research, computational modeling of particle transport and distribution emitted from a Laserjet printer was carried out in a ventilated room. A seated manikin was integrated into the study room and the manikin was evaluated in two cases: heated and unheated. Effects of different ventilation configurations of the room on the particle distribution were studied, including three displacement ventilation systems and a mixing ventilation system. The printer was located on different sides of the manikin and the particle concentrations in the breathing zone of the manikin due to the printer’s particles were evaluated in all the ventilation configurations. The averaged particle concentration in the breathing zone of the manikin was calculated and validated with the experimental and numerical data available in the literature. The results of the present study showed that in case of the heated manikin, the particle concentration due to the printer pollutants is significant in the breathing zone of the manikin. The results also showed that when the printer is located on the front side of the manikin, the particle concentration in the breathing zone is quite high in most of the used ventilation configurations. Furthermore, it was found that the mixing ventilation system has a lower mean particle concentration in the breathing zone compared to the most displacement ventilation systems.

  1. Low sodium diet and pregnancy-induced hypertension: a multi-centre randomised controlled trial

    NARCIS (Netherlands)

    Knuist, M.; Bonsel, G. J.; Zondervan, H. A.; Treffers, P. E.

    1998-01-01

    To examine the effectiveness of the standard policy in the Netherlands to prescribe a sodium restricted diet to prevent or to treat mild pregnancy-induced hypertension. Multi-centre randomised controlled trial between April 1992 and April 1994. Seven practices of independent midwives and one

  2. Characteristics of patients with rheumatoid arthritis presenting for physiotherapy management: a multicentre study.

    Science.gov (United States)

    Kennedy, Norelee; Keogan, Fiona; Fitzpatrick, Martina; Cussen, Grainne; Wallace, Lorraine

    2007-03-01

    To describe the characteristics of patients with rheumatoid arthritis (RA) attending for physiotherapy management in Ireland. Managers of physiotherapy departments in the 53 hospitals in Ireland were invited to participate in a multi-centre observational study over a 6-month period. Data on patients with RA the day of presentation for physiotherapy management were recorded. These data related to patient demographic details, disease management, aids and appliances, splint and orthoses usage and occupational issues. The Health Assessment Questionnaire was also recorded for each patient. A total of 273 patients from eight physiotherapy departments participated in the survey (n = 199; 73% female). Mean age of the participants was 59.3 (SD 12.5) years with mean disease duration of 13.8 (SD 10.6) years. The majority of the patients were inpatients (n = 170, 62%). Sixty-eight per cent of patients had attended for previous physiotherapy treatment and 98% were under current rheumatologist care. Biologic therapies were prescribed to 11% of patients. Use of splint and foot orthoses was high with 133 patients (49%) wearing splints and 75 (31%) wearing foot orthoses. The majority of patients had moderate (n = 119, 44%) or severe (n = 94, 35%) disability as per Health Assessment Questionnaire (HAQ) score. Mean HAQ score was 1.5, with HAQ scores showing increasing disability with increasing age, disease duration and erythrocyte sedimentation rate (ESR) levels. Patients with RA attending for physiotherapy management present with varied profiles. This study provides valuable information on the characteristics of patients with RA attending for physiotherapy management which will contribute to physiotherapy service planning and delivery and will optimize patient care.

  3. Radiofrequency-induced thermal therapy: results of a European multicentre study of resistive ablation of incompetent truncal varicose veins.

    Science.gov (United States)

    Braithwaite, B; Hnatek, L; Zierau, U; Camci, M; Akkersdijk, Gjm; Nio, D; Sarlija, M; Ajduk, M; Santoro, P; Roche, E

    2013-02-01

    To investigate the effectiveness of bipolar radiofrequency-induced thermal therapy (RFITT) in a multicentre non-randomized study. Some 672 incompetent saphenous veins (85% great saphenous varicose vein, 15% short saphenous vein) in 462 patients (56.5% CEAP [clinical, aetiological, anatomical and pathological elements] class 3 or worse) were treated in eight European centres. Patients were assessed between 180 and 360 days postoperatively. Occlusion rates were determined by duplex ultrasound and compared with the power used for treatment, pull back rate and experience of the operating surgeon. Complete occlusion rates of 98.4% were achieved when treatments were performed by an experienced operator (more than 20 cases), when the maximum power setting on the RFITT generator was between 18 and 20 W and the applicator was withdrawn at a rate slower than 1.5 second/cm RFITT is efficacious, well tolerated by patients and has a low incidence of procedure-related post-operative complications.

  4. Current management of intracerebral haemorrhage in China: a national, multi-centre, hospital register study

    Directory of Open Access Journals (Sweden)

    Heeley Emma L

    2011-01-01

    Full Text Available Abstract Background We aimed to examine current practice of the management and secondary prevention of intracerebral haemorrhage (ICH in China where the disease is more common than in Western populations. Methods Data on baseline characteristics, management in-hospital and post-stroke, and outcome of ICH patients are from the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment study, a multi-centre, prospective, 62 hospital registry in China during 2006-07. Results Nearly all ICH patients (n = 1572 received an intravenous haemodiluting agent such as mannitol (96% or a neuroprotectant (72%, and there was high use of intravenous traditional Chinese medicine (TCM (42%. Neurosurgery was undertaken in 137 (9% patients; being overweight, having a low Glasgow Coma Scale (GCS score on admission, and Total Anterior Circulation Syndrome (TACS clinical pattern on admission, were the only baseline factors associated with this intervention in multivariate analyses. Neurosurgery was associated with nearly three times higher risk of death/disability at 3 months post-stroke (odd ratio [OR] 2.60, p Conclusions The management of ICH in China is characterised by high rates of use of intravenous haemodiluting agents, neuroprotectants, and TCM, and of antihypertensives for secondary prevention. The controversial efficacy of these therapies, coupled with the current lack of treatments of proven benefit, is a call for action for more outcomes based research in ICH.

  5. Inflammatory Bowel Disease Phenotype as Risk Factor for Cancer in a Prospective Multicentre Nested Case-Control IG-IBD Study.

    Science.gov (United States)

    Biancone, Livia; Armuzzi, Alessandro; Scribano, Maria Lia; D'Inca, Renata; Castiglione, Fabiana; Papi, Claudio; Angelucci, Erika; Daperno, Marco; Mocciaro, Filippo; Riegler, Gabriele; Fries, Walter; Meucci, Gianmichele; Alvisi, Patrizia; Spina, Luisa; Ardizzone, Sandro; Petruzziello, Carmelina; Ruffa, Alessandra; Kohn, Anna; Vecchi, Maurizio; Guidi, Luisa; Di Mitri, Roberto; Renna, Sara; Emma, Calabrese; Rogai, Francesca; Rossi, Alessandra; Orlando, Ambrogio; Pallone, Francesco

    2016-08-01

    Cancer risk in inflammatory bowel disease [IBD] is still debated. In a prospective, multicentre, nested case-control study, we aimed to characterise incident cases of cancer in IBD. The role of immunomodulators vs clinical characteristics of IBD as risk factors for cancer was also investigated. From January 2012 to December 2014, each IBD patient with incident cancer was matched with two IBD patients without cancer for: IBD type, gender, and age. Risk factors were assessed by multivariate regression analysis. IBD patients considered numbered 44619: 21953 Crohn's disease [CD], 22666 ulcerative colitis [UC]. Cancer occurred in 174 patients: 99 CD [CD-K], 75 UC [UC-K]. Controls included 198 CD [CD-C], 150 UC [UC-C]. Cancer incidence in IBD was 3.9/1000, higher in CD (4.5/1000 [99/21,953]) than in UC (3.3/1000 [75/22,666]; p = 0.042). Cancers involved: digestive system [36.8%], skin [13.2%], urinary tract [12.1%], lung [8.6%], breast [8%], genital tract [6.9%], thyroid [4.6%], lymphoma [3.5%], others [6.3%]. In CD, penetrating behaviour and combined thiopurines and tumour necrosis factor alpha [TNFα] antagonists were risk factors for cancer overall: odds ratio [OR] (95% confidence interval [CI] 2.33 [1.01-5.47]); 1.97 [1.1-3.5]; and for extracolonic cancers 3.9 [1.56-10.1]; 2.15 [1.17-4.1], respectively. In UC, risk factors were pancolitis and disease-related surgery for cancer overall (OR: 2.52 [1.26-5.1]; 5.09 [1.73-17.1]); disease-related surgery for colorectal cancer [CRC] (OR 3.6 [1.0-12]); and extensive and left-sided vs distal UC for extracolonic cancers (OR: 2.55 [1.15-5.9]; 2.6 [1.04-6.6]), respectively. In a multicentre study, penetrating CD and extensive UC were risk factors for cancer overall. Cancer incidence was higher in CD than in UC. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  6. A new Gauss quadrature for multicentre integrals over STOs in the Gaussian integral transform approach

    International Nuclear Information System (INIS)

    Bouferguene, Ahmed

    2005-01-01

    When computing multicentre integrals over Slater-type orbitals (STOs) by means of the Shavitt and Karplus Gaussian integral transforms (Shavitt and Karplus 1962 J. Chem. Phys. 36 550), one usually ends up with a multiple integral of the form ∫ 0 1 du ∫ 0 1 dv ...∫ 0 ∞ dz F(u, v, ..., z) (Shavitt and Karplus 1965 J. Chem. Phys. 43 398) in which all the integrals are inter-related. The most widely used approach for computing such an integral is to apply a product of Gauss-Legendre quadratures for the integrals over [0, 1] while the semi-infinite term is evaluated by a special procedure. Although numerous approaches have been developed to accurately perform the integration over [0, ∞) efficiently, it is the aim of this work to add a new tool that could be of some benefit in carrying out the hard task of multicentre integrals over STOs. The new approach relies on a special Gauss quadrature referred to as Gauss-Bessel to accurately evaluate the semi-infinite integral of interest. In this work, emphasis is put on accuracy rather than efficiency since its aim is essentially to bring a proof of concept showing that Gauss-Bessel quadrature can successfully be applied in the context of multicentre integrals over STOs. The obtained accuracy is comparable to that obtained with other methods available in the literature

  7. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Multicentre randomised controlled equivalence trial. 15 hospitals in the Netherlands. Women with an intermediate to high obstetric risk with an

  8. Implementing diffusion-weighted MRI for body imaging in prospective multicentre trials. Current considerations and future perspectives

    Energy Technology Data Exchange (ETDEWEB)

    DeSouza, N.M.; Winfield, J.M.; Weller, A.; Papoutsaki, M.V.; Doran, S.J.; Collins, D.J. [Institute of Cancer Research and Royal Marsden NHS Foundation Trust, CRUK Cancer Imaging Centre, Surrey (United Kingdom); Waterton, J.C.; Jackson, A. [University of Manchester, Manchester Academic Health Sciences Institute, Manchester (United Kingdom); Fournier, L. [Universite Paris Descartes Sorbonne Paris Cite, Assistance Publique-Hopitaux de Paris, Hopital Europeen Georges Pompidou, Radiology Department, Paris (France); Sullivan, D. [Duke Comprehensive Cancer Institute, Durham, NC (United States); Chenevert, T. [University of Michigan Health System, Department of Radiology, Ann Arbor, MI (United States); Boss, M. [National Institute of Standards and Technology (NIST), Applied Physics Division, Boulder, CO (United States); Trattnig, S. [Medical University of Vienna, Department of Biomedical Imaging and Image Guided Therapy, Vienna (Austria); Liu, Y. [European Organisation for Research and Treatment of Cancer, Brussels (Belgium)

    2018-03-15

    For body imaging, diffusion-weighted MRI may be used for tumour detection, staging, prognostic information, assessing response and follow-up. Disease detection and staging involve qualitative, subjective assessment of images, whereas for prognosis, progression or response, quantitative evaluation of the apparent diffusion coefficient (ADC) is required. Validation and qualification of ADC in multicentre trials involves examination of i) technical performance to determine biomarker bias and reproducibility and ii) biological performance to interrogate a specific aspect of biology or to forecast outcome. Unfortunately, the variety of acquisition and analysis methodologies employed at different centres make ADC values non-comparable between them. This invalidates implementation in multicentre trials and limits utility of ADC as a biomarker. This article reviews the factors contributing to ADC variability in terms of data acquisition and analysis. Hardware and software considerations are discussed when implementing standardised protocols across multi-vendor platforms together with methods for quality assurance and quality control. Processes of data collection, archiving, curation, analysis, central reading and handling incidental findings are considered in the conduct of multicentre trials. Data protection and good clinical practice are essential prerequisites. Developing international consensus of procedures is critical to successful validation if ADC is to become a useful biomarker in oncology. (orig.)

  9. The epidemiology of skin care provided by nurses at home: a multicentre prevalence study.

    Science.gov (United States)

    Kottner, Jan; Boronat, Xavier; Blume-Peytavi, Ulrike; Lahmann, Nils; Suhr, Ralf

    2015-03-01

    The aim of this study was to estimate the frequencies and patterns of skin care and applied skin care products in the home care nursing setting in Germany. Skin care belongs to the core activities of nursing practice. Especially in aged and long-term care settings, clients are vulnerable to various skin conditions. Dry skin is one of the most prevalent problems. Using mild skin cleansers and the regular application of moisturizing leave-on products is recommended. Until today, there are no quantitative empirical data about nursing skin care practice at home in the community. A multicentre cross-sectional study was conducted in July 2012. Home care clients from the German home care nursing setting were randomly selected. Instructed nurse raters performed the data collection using standardized forms. Variables included demographics, skin care needs and skin caring activities. Approximately 60% of home care clients received skin care interventions. The majority were washed and two-thirds received a leave-on product once daily. There was large heterogeneity in cleansing and skin care product use. Most often the product labels were unknown or product types were selected haphazardly. Skin care interventions play a significant role in home care and nurses have a considerable responsibility for skin health. Skin care provided does not meet recent recommendations. The importance of targeted skin cleansing and care might be underestimated. There are a confusing variety of skin care products available and often the labels provide little information regarding the ingredients or guidance about how they affect skin health. © 2014 John Wiley & Sons Ltd.

  10. In vitro comparison in a manikin model: increasing apical enlargement with K3 and K3XF rotary instruments.

    Science.gov (United States)

    Olivieri, Juan Gonzalo; Stöber, Eva; García Font, Marc; González, Jose Antonio; Bragado, Pablo; Roig, Miguel; Duran-Sindreu, Fernando

    2014-09-01

    The aim of the study was to compare the K3 and K3XF systems (SybronEndo, Glendora, CA) after 1 and 2 uses by evaluating apical transportation, working length loss, and working time in a manikin model. Mesial canals of 40 extracted first mandibular molars were instrumented. Radiographs taken after instrumentation with #25, #30, #35, and #40 files were superimposed on the preoperative image in both mesiodistal and buccolingual angulations. AutoCAD (Autodesk Inc, San Rafael, CA) was used to measure working length loss and apical transportation at 0, 0.5, and 1 mm from the working length (WL). The working time was measured. Group comparison was analyzed using post hoc Tukey honestly significant difference tests (P < .05). No significant differences were found in apical transportation, working length loss between K3 and K3XF systems, or between the number of uses. Significant differences were found when canal enlargement was performed to a #35-40 (P < .05). K3 instrumentation performed significantly faster (29.6 ± 15.4) than with the K3XF system (40.2 ± 17.7) (P < .05). No differences were observed in working time when comparing the number of uses. K3 and R-phase K3XF rotary systems shaped curved root canals safely with minimal apical transportation, even up to a 40/04 file. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  11. Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective

    Directory of Open Access Journals (Sweden)

    von Dadelszen Peter

    2010-07-01

    Full Text Available Abstract Background For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs. In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN, to gain insight into the Canadian system. Methods The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Results Each REB had a different application form. Most (n = 9 had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days. Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. Conclusions For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.

  12. A multicentre cohort study assessing day of week effect and outcome from emergency appendicectomy.

    Science.gov (United States)

    Ferguson, Henry J M; Hall, Nigel J; Bhangu, Aneel

    2014-09-01

    There is evidence to suggest that patients undergoing treatment at weekends may be subject to different care processes and outcomes compared with weekdays. This study aimed to determine whether clinical outcomes from weekend appendicectomy are different from those performed on weekdays. Multicentre cohort study during May-June 2012 from 95 centres (89 within the UK). The primary outcome was the 30-day adverse event rate. Multilevel modelling was used to account for clustering within hospitals while adjusting for case mix to produce adjusted ORs and 95% CIs. When compared with Monday, there were no significant differences for other days of the week considering 30-day adverse events in adjusted models. On Sunday, rates of simple appendicitis were highest, and rates of normal (OR 0.62, 95% CI 0.42 to 0.90) and complex appendicitis (OR 0.65, 95% CI 0.46 to 0.93) lowest. This was accompanied by a 43% lower likelihood in use of laparoscopy on Sunday (OR 0.47, 95% CI 0.32 to 0.69), accompanied by the lowest level of consultant presence for the week. When pooling weekends and weekdays, laparoscopy use remained less likely at the weekend (OR 0.68, 95% CI 0.55 to 0.83), with no significant difference for 30-day adverse event rate (OR 1.01, 95% CI 0.80 to 1.29). This study found that weekend appendicectomy was not associated with increased 30-day adverse events. It cannot rule out smaller increases that may be shown by larger studies. It further illustrated that patients operated on at weekends were subject to different care processes, which may expose them to risk. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. Lung volume reduction coil treatment for patients with severe emphysema : a European multicentre trial

    NARCIS (Netherlands)

    Deslee, Gaetan; Klooster, Karin; Hetzel, Martin; Stanzel, Franz; Kessler, Romain; Marquette, Charles-Hugo; Witt, Christian; Blaas, Stefan; Gesierich, Wolfgang; Herth, Felix J. F.; Hetzel, Juergen; van Rikxoort, Eva M.; Slebos, Dirk-Jan

    2014-01-01

    Background The lung volume reduction (LVR) coil is a minimally invasive bronchoscopic nitinol device designed to reduce hyperinflation and improve elastic recoil in severe emphysema. We investigated the feasibility, safety and efficacy of LVR coil treatment in a prospective multicentre cohort trial

  14. Utility of CSF biomarkers in psychiatric disorders: a national multicentre prospective study.

    Science.gov (United States)

    Paquet, Claire; Magnin, Eloi; Wallon, David; Troussière, Anne-Cécile; Dumurgier, Julien; Jager, Alain; Bellivier, Frank; Bouaziz-Amar, Elodie; Blanc, Frédéric; Beaufils, Emilie; Miguet-Alfonsi, Carole; Quillard, Muriel; Schraen, Susanna; Pasquier, Florence; Hannequin, Didier; Robert, Philippe; Hugon, Jacques; Mouton-Liger, François

    2016-06-13

    Affective and psychotic disorders are mental or behavioural patterns resulting in an inability to cope with life's ordinary demands and routines. These conditions can be a prodromal event of Alzheimer's disease (AD). The prevalence of underlying AD lesions in psychiatric diseases is unknown, and it would be helpful to determine them in patients. AD cerebrospinal fluid (CSF) biomarkers (amyloid β, tau and phosphorylated tau) have high diagnostic accuracy, both for AD with dementia and to predict incipient AD (mild cognitive impairment due to AD), and they are sometimes used to discriminate psychiatric diseases from AD. Our objective in the present study was to evaluate the clinical utility of CSF biomarkers in a group of patients with psychiatric disease as the main diagnosis. In a multicentre prospective study, clinicians filled out an anonymous questionnaire about all of their patients who had undergone CSF biomarker evaluation. Before and after CSF biomarker results were obtained, clinicians provided a diagnosis with their level of confidence and information about the treatment. We included patients with a psychiatric disorder as the initial diagnosis. In a second part of the study conducted retrospectively in a followed subgroup, clinicians detailed the psychiatric history and we classified patients into three categories: (1) psychiatric symptoms associated with AD, (2) dual diagnosis and (3) cognitive decline not linked to a neurodegenerative disorder. Of 957 patients, 69 had an initial diagnosis of a psychiatric disorder. Among these 69 patients, 14 (20.2 %) had a CSF AD profile, 5 (7.2 %) presented with an intermediate CSF profile and 50 (72.4 %) had a non-AD CSF profile. Ultimately, 13 (18.8 %) patients were diagnosed with AD. We show that in the AD group psychiatric symptoms occurred later and the delay between the first psychiatric symptoms and the cognitive decline was shorter. This study revealed that about 20 % of patients with a primary

  15. Iatrogenic facial nerve injuries during chronic otitis media surgery: a multicentre retrospective study.

    Science.gov (United States)

    Linder, T; Mulazimoglu, S; El Hadi, T; Darrouzet, V; Ayache, D; Somers, T; Schmerber, S; Vincent, C; Mondain, M; Lescanne, E; Bonnard, D

    2017-06-01

    To give an insight into why, when and where iatrogenic facial nerve (FN) injuries may occur and to explain how to deal with them in an emergency setting. Multicentre retrospective study in eight tertiary referral hospitals over 17 years. Twenty patients with partial or total FN injury during surgery for chronic otitis media (COM) were revised. Indication and type of surgery, experience of the surgeon, intra- and postoperative findings, value of CT scanning, patient management and final FN outcome were recorded. In 12 cases, the nerve was completely transected, but the surgeon was unaware in 11 cases. A minority of cases occurred in academic teaching hospitals. Tympanic segment, second genu and proximal mastoid segments were the sites involved during injury. The FN was not deliberately identified in 18 patients at the time of injury, and nerve monitoring was only applied in one patient. Before revision surgery, CT scanning correctly identified the lesion site in 11 of 12 cases and depicted additional lesions such as damage to the lateral semicircular canal. A greater auricular nerve graft was interposed in 10 cases of total transection and in one partially lesioned nerve: seven of them resulted in an HB III functional outcome. In two of the transected nerves, rerouting and direct end-to-end anastomosis was applied. A simple FN decompression was used in four cases of superficially traumatised nerves. We suggest checklists for preoperative, intraoperative and postoperative management to prevent and treat iatrogenic FN injury during COM surgery. © 2016 John Wiley & Sons Ltd.

  16. Immuno-related polymorphisms and cervical cancer risk: The IARC multicentric case-control study.

    Directory of Open Access Journals (Sweden)

    James McKay

    Full Text Available A small proportion of women who are exposed to infection with human-papillomavirus (HPV develop cervical cancer (CC. Genetic factors may affect the risk of progression from HPV infection to cervical precancer and cancer. We used samples from the International Agency for Research on Cancer (IARC multicentric case-control study to evaluate the association of selected genetic variants with CC. Overall, 790 CC cases and 717 controls from Algeria, Morocco, India and Thailand were included. Cervical exfoliated cells were obtained from control women and cervical exfoliated cells or biopsy specimens from cases. HPV-positivity was determined using a general primer GP5+/6+ mediated PCR. Unconditional logistic regression was used to estimate odds ratios (OR and corresponding 95% confidence intervals (CI of host genotypes with CC risk, using the homozygous wild type genotype as the referent category and adjusting by age and study centre. The association of polymorphisms with the risk of high-risk HPV-positivity among controls was also evaluated. A statistically significant association was observed between single nucleotide polymorphism (SNP CHR6 rs2844511 and CC risk: the OR for carriers of the GA or GG genotypes was 0.70 (95% CI: 0.43-1.14 and 0.61 (95% CI: 0.38-0.98, respectively, relative to carriers of AA genotype (p-value for trend 0.03. We also observed associations of borderline significance with the TIPARP rs2665390 polymorphism, which was previously found to be associated with ovarian and breast cancer, and with the EXOC1 rs13117307 polymorphism, which has been linked to cervical cancer in a large study in a Chinese population. We confirmed the association between CC and the rs2844511 polymorphism previously identified in a GWAS study in a Swedish population. The major histocompatibility region of chromosome 6, or perhaps other SNPs in linkage disequilibrium, may be involved in CC onset.

  17. Disease Transmision and Physical Factors

    DEFF Research Database (Denmark)

    Liu, Li; Yuguo, Li; Nielsen, Peter V.

    2011-01-01

    the two manikins varies from 1.1 m (43 in) to 0.35 m (14 in) in the experiments. A tracer gas N2O is used to represent the gaseous substances exhaled by the source manikin. The concentration of N2O is measured to study the impact of the following parameters on the exposure: distance between manikins...

  18. Analysis of GPR101 and AIP genes mutations in acromegaly: a multicentric study.

    Science.gov (United States)

    Ferraù, Francesco; Romeo, P D; Puglisi, S; Ragonese, M; Torre, M L; Scaroni, C; Occhi, G; De Menis, E; Arnaldi, G; Trimarchi, F; Cannavò, S

    2016-12-01

    This multicentric study aimed to investigate the prevalence of the G protein-coupled receptor 101 (GPR101) p.E308D variant and aryl hydrocarbon receptor interacting protein (AIP) gene mutations in a representative cohort of Italian patients with acromegaly. 215 patients with GH-secreting pituitary adenomas, referred to 4 Italian referral centres for pituitary diseases, have been included. Three cases of gigantism were present. Five cases were classified as FIPA. All the patients have been screened for germline AIP gene mutations and GPR101 gene p.E308D variant. Heterozygous AIP gene variants have been found in 7 patients (3.2 %). Five patients carried an AIP mutation (2.3 %; 4 females): 3 patients harboured the p.R3O4Q mutation, one had the p.R304* mutation and the last one the IVS3+1G>A mutation. The prevalence of AIP mutations was 3.3 % and 2.8 % when considering only the patients diagnosed when they were <30 or <40-year old, respectively. Furthermore, 2.0 % of the patients with a pituitary macroadenoma and 4.2 % of patients resistant to somatostatin analogues treatment were found to harbour an AIP gene mutation. None of the patients was found to carry the GPR101 p.E308D variant. The prevalence of AIP gene mutations among our sporadic and familial acromegaly cases was similar to that one reported in previous studies, but lower when considering only the cases diagnosed before 40 years of age. The GPR101 p.E308D change is unlikely to have a role in somatotroph adenomas tumorigenesis, since none of our sporadic or familial patients tested positive for this variant.

  19. Factors associated with survival of epiploic foramen entrapment colic: a multicentre, international study.

    Science.gov (United States)

    Archer, D C; Pinchbeck, G L; Proudman, C J

    2011-08-01

    Epiploic foramen entrapment (EFE) has been associated with reduced post operative survival compared to other types of colic but specific factors associated with reduced long-term survival of these cases have not been evaluated in a large number of horses using survival analysis. To describe post operative survival of EFE cases and to identify factors associated with long-term survival. A prospective, multicentre, international study was conducted using clinical data and long-term follow-up information for 126 horses diagnosed with EFE during exploratory laparotomy at 15 clinics in the UK, Ireland and USA. Descriptive data were generated and survival analysis performed to identify factors associated with reduced post operative survival. For the EFE cohort that recovered following anaesthesia, survival to hospital discharge was 78.5%. Survival to 1 and 2 years post operatively was 50.6 and 34.3%, respectively. The median survival time of EFE cases undergoing surgery was 397 days. Increased packed cell volume (PCV) and increased length of small intestine (SI) resected were significantly associated with increased likelihood of mortality when multivariable analysis of pre- and intraoperative variables were analysed. When all pre-, intra- and post operative variables were analysed separately, only horses that developed post operative ileus (POI) were shown to be at increased likelihood of mortality. Increased PCV, increased length of SI resected and POI are all associated with increased likelihood of mortality of EFE cases. This emphasises the importance of early diagnosis and treatment and the need for improved strategies in the management of POI in order to reduce post operative mortality in these cases. The present study provides evidence-based information to clinicians and owners of horses undergoing surgery for EFE about long-term survival. These results are applicable to university and large private clinics over a wide geographical area. © 2011 EVJ Ltd.

  20. Lymphoscintigraphy and SPECT/CT in multicentric and multifocal breast cancer: does each tumour have a separate drainage pattern? Results of a Dutch multicentre study (MULTISENT)

    Energy Technology Data Exchange (ETDEWEB)

    Brouwer, O.R. [Antoni van Leeuwenhoek Hospital, Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam (Netherlands); Antoni van Leeuwenhoekhospital, Amsterdam (Netherlands); Vermeeren, L.; Valdes Olmos, R.A. [Antoni van Leeuwenhoek Hospital, Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam (Netherlands); Ploeg, I.M.C. van der; Rutgers, E.J.T.; Oldenburg, H.S.A. [Antoni van Leeuwenhoek Hospital, Department of Surgery, Netherlands Cancer Institute, Amsterdam (Netherlands); Loo, C.E. [Antoni van Leeuwenhoek Hospital, Department of Radiology, Netherlands Cancer Institute, Amsterdam (Netherlands); Pereira-Bouda, L.M.; Smit, F. [Rijnland Hospital, Department of Nuclear Medicine, Leiderdorp (Netherlands); Neijenhuis, P. [Rijnland Hospital, Department of Surgery, Leiderdorp (Netherlands); Vrouenraets, B.C. [Sint Lucas Andreas Hospital, Department of Surgery, Amsterdam (Netherlands); Sivro-Prndelj, F. [Sint Lucas Andreas Hospital, Department of Nuclear Medicine, Amsterdam (Netherlands); Jap-a-Joe, S.M.; Borgstein, P.J. [Onze Lieve Vrouwe Gasthuis, Department of Nuclear Medicine, Amsterdam (Netherlands)

    2012-07-15

    To investigate whether lymphoscintigraphy and SPECT/CT after intralesional injection of radiopharmaceutical into each tumour separately in patients with multiple malignancies in one breast yields additional sentinel nodes compared to intralesional injection of the largest tumour only. Patients were included prospectively at four centres in The Netherlands. Lymphatic flow was studied using planar lymphoscintigraphy and SPECT/CT until 4 h after administration of {sup 99m}Tc-nanocolloid in the largest tumour. Subsequently, the smaller tumour(s) was injected intratumorally followed by the same imaging sequence. Sentinel nodes were intraoperatively localized using a gamma ray detection probe and vital blue dye. Included in the study were 50 patients. Additional lymphatic drainage was depicted after the second and/or third injection in 32 patients (64 %). Comparison of planar images and SPECT/CT images after consecutive injections enabled visualization of the number and location of additional sentinel nodes (32 axillary, 11 internal mammary chain, 2 intramammary, and 1 interpectoral. A sentinel node contained metastases in 17 patients (34 %)). In five patients with a tumour-positive node in the axilla that was visualized after the first injection, an additional involved axillary node was found after the second injection. In two patients, isolated tumour cells were found in sentinel nodes that were only visualized after the second injection, whilst the sentinel nodes identified after the first injection were tumour-negative. Lymphoscintigraphy and SPECT/CT after consecutive intratumoral injections of tracer enable lymphatic mapping of each tumour separately in patients with multiple malignancies within one breast. The high incidence of additional sentinel nodes draining from tumours other than the largest one suggests that separate tumour-related tracer injections may be a more accurate approach to mapping and sampling of sentinel nodes in patients with multicentric or

  1. Lymphoscintigraphy and SPECT/CT in multicentric and multifocal breast cancer: does each tumour have a separate drainage pattern? Results of a Dutch multicentre study (MULTISENT).

    Science.gov (United States)

    Brouwer, O R; Vermeeren, L; van der Ploeg, I M C; Valdés Olmos, R A; Loo, C E; Pereira-Bouda, L M; Smit, F; Neijenhuis, P; Vrouenraets, B C; Sivro-Prndelj, F; Jap-a-Joe, S M; Borgstein, P J; Rutgers, E J Th; Oldenburg, H S A

    2012-07-01

    To investigate whether lymphoscintigraphy and SPECT/CT after intralesional injection of radiopharmaceutical into each tumour separately in patients with multiple malignancies in one breast yields additional sentinel nodes compared to intralesional injection of the largest tumour only. Patients were included prospectively at four centres in The Netherlands. Lymphatic flow was studied using planar lymphoscintigraphy and SPECT/CT until 4 h after administration of (99m)Tc-nanocolloid in the largest tumour. Subsequently, the smaller tumour(s) was injected intratumorally followed by the same imaging sequence. Sentinel nodes were intraoperatively localized using a gamma ray detection probe and vital blue dye. Included in the study were 50 patients. Additional lymphatic drainage was depicted after the second and/or third injection in 32 patients (64%). Comparison of planar images and SPECT/CT images after consecutive injections enabled visualization of the number and location of additional sentinel nodes (32 axillary, 11 internal mammary chain, 2 intramammary, and 1 interpectoral. A sentinel node contained metastases in 17 patients (34%). In five patients with a tumour-positive node in the axilla that was visualized after the first injection, an additional involved axillary node was found after the second injection. In two patients, isolated tumour cells were found in sentinel nodes that were only visualized after the second injection, whilst the sentinel nodes identified after the first injection were tumour-negative. Lymphoscintigraphy and SPECT/CT after consecutive intratumoral injections of tracer enable lymphatic mapping of each tumour separately in patients with multiple malignancies within one breast. The high incidence of additional sentinel nodes draining from tumours other than the largest one suggests that separate tumour-related tracer injections may be a more accurate approach to mapping and sampling of sentinel nodes in patients with multicentric or

  2. Chemical protective clothing; a study into the ability of staff to perform lifesaving procedures

    Science.gov (United States)

    Coates, M.; Jundi, A.; James, M.

    2000-01-01

    Objective—To investigate the ability of medical and nursing staff to perform certain tasks while wearing a chemical protection suit with a respirator. Tasks chosen were those that would be required before decontamination. Methods—Ten experienced accident and emergency doctors (middle grade and consultants) and 10 nurses were asked to perform certain tasks that were judged to be life saving, relevant to triage, or necessary to confirm death, on an advanced life support manikin, while wearing a TST-Sweden chemical protection suit. The operators were objectively assessed by one of the authors for achieving each task, then asked to make a subjective assessment of the difficulty experienced. Results—Medical staff were asked to ventilate the manikin using a bag-valve-mask, intubate within 30 seconds, apply monitor electrodes and cables and check cardiac rhythm, apply gel pads and defibrillate safely, and finally, fold the cruciform triage card to show "RED", and attach it to the manikin. All the doctors completed these tasks, except for one, who could only intubate the manikin after several attempts. Nursing staff were asked to open and apply an oxygen mask, adjust oxygen flow, size and insert an oropharyngeal airway, ventilate the manikin using a bag-valve-mask, apply a pressure bandage to a limb, and fold the cruciform triage card to show "YELLOW", and attach it to the manikin. All the nurses completed these tasks. Operators reported varying degrees of difficulty, the most difficult tasks were those requiring fine movements or delicate control. Generally, operators found the butyl rubber gloves cumbersome. Communication difficulties were frequently reported. Although only intubation was formally timed, tasks were perceived to take longer. Some operators found the suits too warm and uncomfortable. Conclusion—Should the need arise, the TST-Sweden chemical protection suits would enable experienced doctors and nurses to perform lifesaving measures effectively

  3. Multicentre epidemiological survey on the incidence of Streptococcus agalactiae in pregnancy

    Directory of Open Access Journals (Sweden)

    Leonardo Lodolo

    2010-03-01

    Full Text Available ß-hemolytic streptococci group B (GBS cause infections of the urinary tract, endometrium, amnion, and superinfection of wounds, with complications in 2% -4% of cases in pregnant woman.The infection transmitted to newborns is a cause of sepsis and meningitis with high incidence of mortality.A recent report on a multicentric study of the ISS, showed that detection of S. agalactiae in pregnant women in different realities of healthcare, ranging from 3.9% to 19.4%. This survey covers a sample of 29607 women screened in a total of 36852 childbirths, with a positivity of 4183 subjects equal to 14.1%. Thanks to the GBS Study Group of Piemonte and Valle d’Aosta microbiology laboratories, with the support of 42 study centres have been involved. Collection techniques, types of medium, environmental of incubation of the culture, possible enrichment in broth, of the swabs of 28491 women during 2006/2007 have been considered. 24.36% were vaginal swab while 75.64% vagino/rectal. According to data collected at 31 centers with eligible data (22,175 pregnant GBS positivity was 12.7% (CI [Confidence Interval] + / -95%: 13.1% -12.2% with wide variability between individual centers (2% -22.6%. The enrichment broth is used by 6 out of 9 centers with positivity> 15% (M: 20.05%, from 6 to 14 with positivity between 10-15% (M: 12.61%, from none to 8 centers with less than 10% positivity (M: 4.95%.This multicentre survey underlined the preference for vagino/rectal swab, as recommended by the literature. The frequency of GBS positivity of pregnant women on the whole samples is similar to that found in other national surveys, even if with large differences between the different centers.The sensitivity tends to increase with the use of enrichment techniques, whose use is uneven between the centers, perhaps indicating the need for greater uniformity of protocols based on the results of microbiological analysis EBM (Evidence Based Medicine.

  4. Erysipelas of the leg (cellulitis in sub-Saharan Africa: A multicentric study of 562 cases

    Directory of Open Access Journals (Sweden)

    Bayaki Saka

    2017-01-01

    Full Text Available Introduction: Erysipelas of the leg is a common and serious infection. We carried out this study aiming at describing the epidemiological and clinical characteristics, and assessing the risks factors associated with the local complications of erysipelas of the leg in sub-Saharan Africa. Methods: This was a prospective multicentric study carried out in the dermatology units of Hospitals located in seven sub-Saharan African countries during a period of 12 months. Patients aged 15 and above with a first episode of erysipelas of the leg were recruited. Results: In this study, 562 patients were recruited, having a mean age of 43.7±16.9 years and a sex-ratio (M/F of 0.67. Patients infected on one leg were 562 while those infected with two were 27. Bullous forms of the disease were observed in 95 patients, while purpuric forms were observed in 167 patients. The existence of a point of entry (485 cases, obesity (230, lymph edema (130 and the use of bleaching agents (97 were the mains risk factors. Complications during the course of the infection such as necrotizing fasciitis (34 cases and abscesses (63 cases were observed. They were due to the use of antibiotics and non-steroidal anti-inflammatory treatments, and the use of cataplasm. Conclusion: This study reveals that existence of a point of entry, obesity and lymph edema, and the use of bleaching agents were the mains risk factors influencing the local complications of erysipelas of the leg. Necrotizing fasciitis and abscesses were influenced by the use of antibiotics and non-steroidal anti-inflammatory treatments, and the use of cataplasm.

  5. ECSPECT prospective multicentre registry for single-port laparoscopic colorectal procedures

    DEFF Research Database (Denmark)

    Weiss, Helmut; Zorron, R; Vestweber, K-H

    2017-01-01

    BACKGROUND: The international multicentre registry ECSPECT (European Consensus of Single Port Expertise in Colorectal Treatment) was established to evaluate the general feasibility and safety of single-port colorectal surgery with regard to preoperative risk assessment. METHODS: Consecutive...... patients undergoing single-port colorectal surgery were enrolled from 11 European centres between March 2010 and March 2014. Data were analysed to assess patient-, technique- and procedure-dependent parameters. A validated sex-adjusted risk chart was developed for prediction of single-port colorectal...

  6. Study for every other day administration of vonoprazan in maintenance treatment of erosive GERD: study protocol for a multicentre randomised cross-over study.

    Science.gov (United States)

    Kato, Mototsugu; Ito, Noriko; Demura, Mamiko; Kubo, Kimitoshi; Mabe, Katsuhiro; Harada, Naohiko

    2018-01-01

    The first drug selected for treatment of gastro-oesophageal reflux disease (GERD) and prevention of the recurrence is a proton pump inhibitor (PPI), but recently, a potassium-competitive acid blocker (P-CAB) was put on the market in Japan. Its onset of effect is faster than PPI, and it takes more than 2 days to recover acid secretion after the withdrawal period. Therefore, unlike PPI, the usefulness of every other day administration or discontinuous administration is expected. This study is a prospective, multicentre, open-label, two-period randomised cross-over study to compare the efficacy and safety of PPI every other day administration and P-CAB every other day administration in 120 patients who receive erosive GERD maintenance therapy with PPI. Patients will be randomly allocated to receive 4 weeks P-CAB or PPI followed by 4 weeks cross over, where those on P-CAB will receive PPI and vice versa. The primary endpoint is proportion of asymptomatic patients. Secondary endpoints are suppressive effect of GERD symptoms, proportion of asymptomatic patients at each time point, safety and cost-saving effect of P-CAB every other day administration, compliance with every other day administration, and proportion of asymptomatic patients at the first month of study drug administration. This study was approved by the National Hospital Organization Central Review Board for Clinical Trials (5 December 2017). If P-CAB every other day administration is established as one of GERD maintenance therapies, there is merit in both medical cost reduction and the safety to alleviate elevation in serum gastrin. UMIN000034701.

  7. Knowledge, attitudes, and smoking behaviours among physicians specializing in public health: a multicentre study.

    Science.gov (United States)

    La Torre, Giuseppe; Saulle, Rosella; Unim, Brigid; Angelillo, Italo Francesco; Baldo, Vincenzo; Bergomi, Margherita; Cacciari, Paolo; Castaldi, Silvana; Del Corno, Giuseppe; Di Stanislao, Francesco; Panà, Augusto; Gregorio, Pasquale; Grillo, Orazio Claudio; Grossi, Paolo; La Rosa, Francesco; Nante, Nicola; Pavia, Maria; Pelissero, Gabriele; Quarto, Michele; Ricciardi, Walter; Romano, Gabriele; Schioppa, Francesco Saverio; Fallico, Roberto; Siliquini, Roberta; Triassi, Maria; Vitale, Francesco; Boccia, Antonio

    2014-01-01

    Healthcare professionals have an important role to play both as advisers-influencing smoking cessation-and as role models. However, many of them continue to smoke. The aims of this study were to examine smoking prevalence, knowledge, attitudes, and behaviours among four cohorts physicians specializing in public health, according to the Global Health Profession Students Survey (GHPSS) approach. A multicentre cross-sectional study was carried out in 24 Italian schools of public health. The survey was conducted between January and April 2012 and it was carried out a census of students in the selected schools for each years of course (from first to fourth year of attendance), therefore among four cohorts of physicians specializing in Public Health (for a total of n. 459 medical doctors). The GHPSS questionnaires were self-administered via a special website which is created ad hoc for the survey. Logistic regression model was used to identify possible associations with tobacco smoking status. Hosmer-Lemeshow test was performed. The level of significance was P ≤ 0.05. A total of 388 answered the questionnaire on the website (85%), of which 81 (20.9%) declared to be smokers, 309 (79.6%) considered health professionals as behavioural models for patients, and 375 (96.6%) affirmed that health professionals have a role in giving advice or information about smoking cessation. Although 388 (89.7%) heard about smoking related issues during undergraduate courses, only 17% received specific smoking cessation training during specialization. The present study highlights the importance of focusing attention on smoking cessation training, given the high prevalence of smokers among physicians specializing in public health, their key role both as advisers and behavioural models, and the limited tobacco training offered in public health schools.

  8. Knowledge, Attitudes, and Smoking Behaviours among Physicians Specializing in Public Health: A Multicentre Study

    Directory of Open Access Journals (Sweden)

    Giuseppe La Torre

    2014-01-01

    Full Text Available Background. Healthcare professionals have an important role to play both as advisers—influencing smoking cessation—and as role models. However, many of them continue to smoke. The aims of this study were to examine smoking prevalence, knowledge, attitudes, and behaviours among four cohorts physicians specializing in public health, according to the Global Health Profession Students Survey (GHPSS approach. Materials and Methods. A multicentre cross-sectional study was carried out in 24 Italian schools of public health. The survey was conducted between January and April 2012 and it was carried out a census of students in the selected schools for each years of course (from first to fourth year of attendance, therefore among four cohorts of physicians specializing in Public Health (for a total of n. 459 medical doctors. The GHPSS questionnaires were self-administered via a special website which is created ad hoc for the survey. Logistic regression model was used to identify possible associations with tobacco smoking status. Hosmer-Lemeshow test was performed. The level of significance was P≤0.05. Results. A total of 388 answered the questionnaire on the website (85%, of which 81 (20.9% declared to be smokers, 309 (79.6% considered health professionals as behavioural models for patients, and 375 (96.6% affirmed that health professionals have a role in giving advice or information about smoking cessation. Although 388 (89.7% heard about smoking related issues during undergraduate courses, only 17% received specific smoking cessation training during specialization. Conclusions. The present study highlights the importance of focusing attention on smoking cessation training, given the high prevalence of smokers among physicians specializing in public health, their key role both as advisers and behavioural models, and the limited tobacco training offered in public health schools.

  9. A multi-centre evaluation of oral cancer in Southern and Western Nigeria: an African oral pathology research consortium initiative.

    Science.gov (United States)

    Omitola, Olufemi Gbenga; Soyele, Olujide Oladele; Sigbeku, Opeyemi; Okoh, Dickson; Akinshipo, Abdulwarith Olaitan; Butali, Azeez; Adeola, Henry Ademola

    2017-01-01

    Oral cancer is a leading cause of cancer deaths among African populations. Lack of standard cancer registries and under-reporting has inaccurately depicted its magnitude in Nigeria. Development of multi-centre collaborative oral pathology networks such as the African Oral Pathology Research Consortium (AOPRC) facilitates skill and expertise exchange and fosters a robust and systematic investigation of oral diseases across Africa. In this descriptive cross-sectional study, we have leveraged the auspices of the AOPRC to examine the burden of oral cancer in Nigeria, using a multi-centre approach. Data from 4 major tertiary health institutions in Western and Southern Nigeria was generated using a standardized data extraction format and analysed using the SPSS data analysis software (version 20.0; SPSS Inc. Chicago, IL). Of the 162 cases examined across the 4 centres, we observed that oral squamous cell carcinomas (OSCC) occurred mostly in the 6 th and 7 th decades of life and maxillary were more frequent than mandibular OSCC lesions. Regional variations were observed both for location, age group and gender distribution. Significant regional differences was found between poorly, moderately and well differentiated OSCC (p value = 0.0071). A multi-centre collaborative oral pathology research approach is an effective way to achieve better insight into the patterns and distribution of various oral diseases in men of African descent. The wider outlook for AOPRC is to employ similar approaches to drive intensive oral pathology research targeted at addressing the current morbidity and mortality of various oral diseases across Africa.

  10. Chasing the effects of Pre-analytical Confounders - a Multicentre Study on CSF-AD biomarkers

    Directory of Open Access Journals (Sweden)

    Maria Joao Leitao

    2015-07-01

    Full Text Available Core cerebrospinal fluid (CSF biomarkers-Aβ42, Tau and pTau–have been recently incorporated in the revised criteria for Alzheimer’s disease (AD. However, their widespread clinical application lacks standardization. Pre-analytical sample handling and storage play an important role in the reliable measurement of these biomarkers across laboratories. In this study, we aim to surpass the efforts from previous studies, by employing a multicentre approach to assess the impact of less studied CSF pre-analytical confounders in AD-biomarkers quantification. Four different centres participated in this study and followed the same established protocol. CSF samples were analysed for three biomarkers (Aβ42, Tau and pTau and tested for different spinning conditions (temperature: Room temperature (RT vs. 4oC; speed: 500g vs. 2000g vs. 3000g, storage volume variations (25%, 50% and 75% of tube total volume as well as freezing-thaw cycles (up to 5 cyles. The influence of sample routine parameters, inter-centre variability and relative value of each biomarker (reported as normal/abnormal, was analysed. Centrifugation conditions did not influence biomarkers levels, except for samples with a high CSF total protein content, where either non centrifugation or centrifugation at RT, compared to 4ºC, led to higher Aβ42 levels. Reducing CSF storage volume from 75% to 50% of total tube capacity, decreased Aβ42 concentration (within analytical CV of the assay, whereas no change in Tau or pTau was observed. Moreover, the concentration of Tau and pTau appears to be stable up to 5 freeze-thaw cycles, whereas Aβ42 levels decrease if CSF is freeze-thawed more than 3 times. This systematic study reinforces the need for CSF centrifugation at 4ºC prior to storage and highlights the influence of storage conditions in Aβ42 levels. This study contributes to the establishment of harmonized standard operating procedures that will help reducing inter-lab variability of CSF

  11. MULTICENTRIC T-CELL LYMPHOMA AND CUTANEOUS HEMANGIOSARCOMA IN A CAPTIVE CHEETAH (ACINONYX JUBATUS).

    Science.gov (United States)

    Lindemann, Dana M; Carpenter, James W; Nietfeld, Jerome C; Gonzalez, Estehela; Hallman, Mackenzie; Hause, Ben M

    2015-12-01

    A 13-yr-old intact male cheetah (Acinonyx jubatus) presented for evaluation after a 4-mo history of intermittent lethargy and increased expiratory effort. The clinical signs were initially noted after the diagnosis and death of its 13-yr-old male sibling with solitary hepatic T-cell lymphoma. Physical examination findings included thin body condition, harsh lung sounds, peripheral lymphadenopathy, and a cutaneous mass on the right medial tarsus and scrotum. Excisional biopsies diagnosed well-differentiated cutaneous hemangiosarcomas. Thoracic radiographs revealed a cranial mediastinal mass. Complete blood count and serum biochemical analyses showed a leukocytosis with persistent lymphocytosis, progressive azotemia, and markedly elevated alkaline phosphatase. Because of the cheetah's declining quality of life, euthanasia was elected. Postmortem examination, histopathology, and immunohistochemical staining revealed multicentric T-cell lymphoma. Feline leukemia virus (FeLV) enzyme-linked immunosorbent assay, FeLV polymerase chain reaction (whole blood), and viral metagenomic analysis were negative. This is the first case of cutaneous hemangiosarcoma and multicentric T-cell lymphoma reported in a FeLV-negative cheetah.

  12. Prospective Multicentre Study on the Epidemiology and Current Therapeutic Management of Severe Bronchiolitis in Spain

    Directory of Open Access Journals (Sweden)

    Jose C. Flores-González

    2017-01-01

    Full Text Available Objective. To determine the epidemiology and therapeutic management of patients with severe acute bronchiolitis (AB admitted to paediatric intensive care units (PICUs in Spain. Design. Descriptive, prospective, multicentre study. Setting. Sixteen Spanish PICUs. Patients. Patients with severe AB who required admission to any of the participating PICUs over 1 year. Interventions. Both epidemiological variables and medical treatment received were recorded. Results. A total of 262 patients were recruited; 143 were male (54.6%, with median age of 1 month (0–23. Median stay in the PICU was 7 days (1–46. Sixty patients (23% received no nebuliser treatment, while the rest received a combination of inhalation therapies. One-quarter of patients (24.8% received corticosteroids and 56.5% antibiotic therapy. High-flow oxygen therapy was used in 14.3% and noninvasive ventilation (NIV was used in 75.6%. Endotracheal intubation was required in 24.4% of patients. Younger age, antibiotic therapy, and invasive mechanical ventilation (IMV were risk factors that significantly increased the stay in the PICU. Conclusions. Spanish PICUs continue to routinely use nebulised bronchodilator treatment and corticosteroid therapy. Despite NIV being widely used in this condition, intubation was required in one-quarter of cases. Younger age, antibiotic therapy, and IMV were associated with a longer stay in the PICU.

  13. An analysis of the efficacy of bag-valve-mask ventilation and chest compression during different compression-ventilation ratios in manikin-simulated paediatric resuscitation.

    Science.gov (United States)

    Kinney, S B; Tibballs, J

    2000-01-01

    The ideal chest compression and ventilation ratio for children during performance of cardiopulmonary resuscitation (CPR) has not been determined. The efficacy of chest compression and ventilation during compression ventilation ratios of 5:1, 10:2 and 15:2 was examined. Eighteen nurses, working in pairs, were instructed to provide chest compression and bag-valve-mask ventilation for 1 min with each ratio in random on a child-sized manikin. The subjects had been previously taught paediatric CPR within the last 3 or 5 months. The efficacy of ventilation was assessed by measurement of the expired tidal volume and the number of breaths provided. The rate of chest compression was guided by a metronome set at 100/min. The efficacy of chest compressions was assessed by measurement of the rate and depth of compression. There was no significant difference in the mean tidal volume or the percentage of effective chest compressions delivered for each compression-ventilation ratio. The number of breaths delivered was greatest with the ratio of 5:1. The percentage of effective chest compressions was equal with all three methods but the number of effective chest compressions was greatest with a ratio of 5:1. This study supports the use of a compression-ventilation ratio of 5:1 during two-rescuer paediatric cardiopulmonary resuscitation.

  14. Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol.

    Science.gov (United States)

    Sanders-Pinheiro, Helady; Colugnati, Fernando Antonio Basile; Marsicano, Elisa Oliveira; De Geest, Sabina; Medina, José Osmar Pestana

    2018-02-20

    Non-adherence to immunosuppressive therapy is a prevalent risk factor for poor clinical and after kidney transplantation (KT), and has contributed to the lack of improvement in long-term graft survival over the past decade. Understanding the multilevel correlates and risk factors of non-adherence is crucial to determine the optimal level for planning interventions, namely at the patient, health care provider, KT centre, and health care system level. Brazil, having the largest public transplantation program in the world and with regional differences regarding access to health services and service implementation, is in a unique position to study this multilevel approach. Therefore, the Adhere Brazil Study (ADHERE BRAZIL) was designed to assess the prevalence and variability of non-adherence to immunosuppressants and to health behaviours among adult KT recipients in Brazil, and to assess the multilevel correlates of non-adherence to immunosuppressive medication. We describe the rationale, design, and methodology of the ADHERE BRAZIL study. This is an observational, cross-sectional, multicentre study that includes 20 Brazilian KT centres. A stratified sampling approach is used, based on strata, with the following characteristics considered: geographical region and transplant activity (number of KTs per year). A random sample of patients (proportional to the size of the centre within each stratum) is selected from each centre. The prevalence of different health behaviours is assessed through self-report. The assessment of multilevel correlates of non-adherence is guided by the ecological model that considers factors at the level of the patient, health-care professional, and transplant centre, using established instruments or instruments developed for this study. Data will be collected over an 18-month period, with information obtained during the regular follow-up visits to the transplant outpatient clinic and directly entered into the Research Electronic Data Capture

  15. Single-Port Transumbilical Laparoscopic Appendectomy: A Preliminary Multicentric Comparative Study in 87 Patients with Acute Appendicitis

    Directory of Open Access Journals (Sweden)

    Ramon Vilallonga

    2012-01-01

    Full Text Available Introduction. Laparoscopic appendectomy (LA has been performed in many approaches such as open, laparoscopic and recently Single Port Access (SPAA. In order to elucidate its potential advantages, we compared the two laparoscopic approaches. Methods. 87 patients were included in a multicentric study for suspected appendicitis in order to perform (SPAA appendectomy or laparoscopic appendectomy (LA. All outcomes, including blood loss, operative time, complications, and length of stay and pain were recorded prospectively. Results. There were 46 patients in the SPAA group and 41 in the LAG with a mean operative time of 40,4 minutes in the SPAA group and 35,0 minutes in the LA group. Only one patient was converted to an open approach. We described only 2 complications. Pain was graded 2,8 in the SPAA group and 2,9 in the LA group, according to the AVS after 24 hours. Patients in the SPAA Group were more satisfied (7,5 versus 6,9 (<0.05. Same results were found for the cosmetic result (8,6 versus 7,4 (<0.05. Conclusion. Using the single port approach feasible and safe. The true benefit of the technique should be assessed by new randomised controlled trials.

  16. Quality control within the multicentre perfusion CT study of primary colorectal cancer (PROSPeCT): results of an iodine density phantom study

    International Nuclear Information System (INIS)

    Lewis, Maria; Honey, Ian; Goh, Vicky; Beggs, Shaun; Bridges, Andrew; Wayte, Sarah; Clewer, Philip; Davis, Anne; Foy, Trevelyan; Fuller, Karen; George, Jennifer; Higginson, Antony; Iball, Gareth; Mutch, Steve; Neil, Shellagh; Sutton, David; Rivett, Cat; Slater, Andrew; Weir, Nick

    2014-01-01

    To assess the cross-centre consistency of iodine enhancement, contrast-to-noise ratio and radiation dose in a multicentre perfusion CT trial of colorectal cancer. A cylindrical water phantom containing different iodine inserts was examined on seven CT models in 13 hospitals. The relationship between CT number (Hounsfield units, HU) and iodine concentration (milligrams per millilitre) was established and contrast-to-noise ratios (CNRs) calculated. Radiation doses (CTDI vol , DLP) were compared across all sites. There was a linear relationship between CT number and iodine density. Iodine enhancement varied by a factor of at most 1.10, and image noise by at most 1.5 across the study sites. At an iodine concentration of 1 mg ml -1 and 100 kV, CNRs ranged from 3.6 to 4.8 in the 220-mm phantom and from 1.4 to 1.9 in the 300-mm phantom. Doses varied by a factor of at most 2.4, but remained within study dose constraints. Iterative reconstruction algorithms did not alter iodine enhancement but resulted in reduced image noise by a factor of at most 2.2, allowing a potential dose decrease of at most 80 % compared to filtered back projection (FBP). Quality control of CT performance across centres indicates that CNR values remain relatively consistent across all sites, giving acceptable image quality within the agreed dose constraints. (orig.)

  17. Quality control within the multicentre perfusion CT study of primary colorectal cancer (PROSPeCT): results of an iodine density phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, Maria; Honey, Ian [Trust, Medical Physics Department, Guy' s and St. Thomas' NHS Foundation, London (United Kingdom); Goh, Vicky [King' s College London, St Thomas' Hospital, Division of Imaging Sciences and Biomedical Engineering, London (United Kingdom); Beggs, Shaun [Bradford Teaching Hospitals NHS Foundation Trust, Radiation Physics Services, Bradford (United Kingdom); Bridges, Andrew; Wayte, Sarah [Radiology Physics University Hospitals Coventry and Warwickshire NHS Trust, Coventry (United Kingdom); Clewer, Philip [Medical Physics Department, University Hospital Southampton NHS Foundation Trust, Southampton (United Kingdom); Davis, Anne [Portsmouth Hospitals NHS Trust, Medical Physics Department, Portsmouth (United Kingdom); Foy, Trevelyan [Royal Cornwall Hospital NHS Trust, Medical Physics Department, Truro (United Kingdom); Fuller, Karen [Sheffield Teaching Hospitals NHS Foundation Trust, Medical Physics Department, Sheffield (United Kingdom); George, Jennifer [University Hospital of North Staffordshire NHS Trust, Medical Physics Department, Stoke-on-Trent (United Kingdom); Higginson, Antony [Portsmouth Hospitals NHS Trust, Department of Radiology, Portsmouth (United Kingdom); Iball, Gareth [Leeds Teaching Hospitals NHS Trust, Department of Medical Physics and Engineering, Leeds (United Kingdom); Mutch, Steve [Oxford University Hospitals NHS Trust, Radiation Physics and Protection Department, Oxford (United Kingdom); Neil, Shellagh; Sutton, David [NHS Tayside, Medical Physics Department, Dundee, Scotland (United Kingdom); Rivett, Cat [Plymouth Hospitals NHS Trust, Clinical and Radiation Physics, Plymouth (United Kingdom); Slater, Andrew [Oxford University Hospitals NHS Trust, Department of Radiology, Oxford (United Kingdom); Weir, Nick [Queen' s Medical Research Institute, Clinical Research Imaging Centre, Edinburgh, Scotland (United Kingdom); Collaboration: on behalf of the PROSPeCT Investigators

    2014-09-15

    To assess the cross-centre consistency of iodine enhancement, contrast-to-noise ratio and radiation dose in a multicentre perfusion CT trial of colorectal cancer. A cylindrical water phantom containing different iodine inserts was examined on seven CT models in 13 hospitals. The relationship between CT number (Hounsfield units, HU) and iodine concentration (milligrams per millilitre) was established and contrast-to-noise ratios (CNRs) calculated. Radiation doses (CTDI{sub vol}, DLP) were compared across all sites. There was a linear relationship between CT number and iodine density. Iodine enhancement varied by a factor of at most 1.10, and image noise by at most 1.5 across the study sites. At an iodine concentration of 1 mg ml{sup -1} and 100 kV, CNRs ranged from 3.6 to 4.8 in the 220-mm phantom and from 1.4 to 1.9 in the 300-mm phantom. Doses varied by a factor of at most 2.4, but remained within study dose constraints. Iterative reconstruction algorithms did not alter iodine enhancement but resulted in reduced image noise by a factor of at most 2.2, allowing a potential dose decrease of at most 80 % compared to filtered back projection (FBP). Quality control of CT performance across centres indicates that CNR values remain relatively consistent across all sites, giving acceptable image quality within the agreed dose constraints. (orig.)

  18. The utility of e-Learning to support training for a multicentre bladder online adaptive radiotherapy trial (TROG 10.01-BOLART).

    Science.gov (United States)

    Foroudi, Farshad; Pham, Daniel; Bressel, Mathias; Tongs, David; Rolfo, Aldo; Styles, Colin; Gill, Suki; Kron, Tomas

    2013-10-01

    An e-Learning programme appeared useful for providing training and information regarding a multi-centre image guided radiotherapy trial. The aim of this study is to demonstrate the utility of this e-Learning programme. Modules were created on relevant pelvic anatomy, Cone Beam CT soft tissue recognition and trial details. Radiation therapist participants' knowledge and confidence were evaluated before, at the end of, and after at least 6 weeks of e-Learning (long term). One hundred and eighty-five participants were recruited from 12 centres, with 118 in the first, and 67 in the second cohort. One hundred and forty-six participants had two tests (pre and post e-Learning) and 39 of these had three tests (pre, post, and long term). There was an increase confidence after completion of modules (pe-Learning for a multi-centre clinical trial was feasible and improved confidence and knowledge. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  19. Prevalence and predictors of alcohol use during pregnancy: findings from international multicentre cohort studies.

    Science.gov (United States)

    O'Keeffe, Linda M; Kearney, Patricia M; McCarthy, Fergus P; Khashan, Ali S; Greene, Richard A; North, Robyn A; Poston, Lucilla; McCowan, Lesley M E; Baker, Philip N; Dekker, Gus A; Walker, James J; Taylor, Rennae; Kenny, Louise C

    2015-07-06

    To compare the prevalence and predictors of alcohol use in multiple cohorts. Cross-cohort comparison of retrospective and prospective studies. Population-based studies in Ireland, the UK, Australia and New Zealand. 17,244 women of predominantly Caucasian origin from two Irish retrospective studies (Growing up in Ireland (GUI) and Pregnancy Risk Assessment Monitoring System Ireland (PRAMS Ireland)), and one multicentre prospective international cohort, Screening for Pregnancy Endpoints (SCOPE) study. Prevalence of alcohol use pre-pregnancy and during pregnancy across cohorts. Sociodemographic factors associated with alcohol consumption in each cohort. Alcohol consumption during pregnancy in Ireland ranged from 20% in GUI to 80% in SCOPE, and from 40% to 80% in Australia, New Zealand and the UK. Levels of exposure also varied substantially among drinkers in each cohort ranging from 70% consuming more than 1-2 units/week in the first trimester in SCOPE Ireland, to 46% and 15% in the retrospective studies. Smoking during pregnancy was the most consistent predictor of gestational alcohol use in all three cohorts, and smokers were 17% more likely to drink during pregnancy in SCOPE, relative risk (RR)=1.17 (95% CI 1.12 to 1.22), 50% more likely to drink during pregnancy in GUI, RR=1.50 (95% CI 1.36 to 1.65), and 42% more likely to drink in PRAMS, RR=1.42 (95% CI 1.18 to 1.70). Our data suggest that alcohol use during pregnancy is prevalent and socially pervasive in the UK, Ireland, New Zealand and Australia. New policy and interventions are required to reduce alcohol prevalence both prior to and during pregnancy. Further research on biological markers and conventions for measuring alcohol use in pregnancy is required to improve the validity and reliability of prevalence estimates. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  20. Joys and challenges of relationships in Scotland and New Zealand rural midwifery: A multicentre study.

    Science.gov (United States)

    Crowther, Susan; Deery, Ruth; Daellenbach, Rea; Davies, Lorna; Gilkison, Andrea; Kensington, Mary; Rankin, Jean

    2018-04-21

    Globally there are challenges meeting the recruitment and retention needs for rural midwifery. Rural practice is not usually recognised as important and feelings of marginalisation amongst this workforce are apparent. Relationships are interwoven throughout midwifery and are particularly evident in rural settings. However, how these relationships are developed and sustained in rural areas is unclear. To study the significance of relationships in rural midwifery and provide insights to inform midwifery education. Multi-centre study using online surveys and discussion groups across New Zealand and Scotland. Descriptive and template analysis were used to organise, examine and analyse the qualitative data. Rural midwives highlighted how relationships with health organisations, each other and women and their families were both a joy and a challenge. Social capital was a principal theme. Subthemes were (a) working relationships, (b) respectful communication, (c) partnerships, (d) interface tensions, (e) gift of time facilitates relationships. To meet the challenges of rural practice the importance of relationship needs acknowledging. Relationships are created, built and sustained at a distance with others who have little appreciation of the rural context. Social capital for rural midwives is thus characterised by social trust, community solidarity, shared values and working together for mutual benefit. Rural communities generally exhibit high levels of social capital and this is key to sustainable rural midwifery practice. Midwives, educationalists and researchers need to address the skills required for building social capital in rural midwifery practice. These skills are important in midwifery pre- and post-registration curricula. Copyright © 2018 Australian College of Midwives. All rights reserved.

  1. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder--study protocol of the randomised, multi-centre controlled SOSTA--net trial.

    Science.gov (United States)

    Freitag, Christine M; Cholemkery, Hannah; Elsuni, Leyla; Kroeger, Anne K; Bender, Stephan; Kunz, Cornelia Ursula; Kieser, Meinhard

    2013-01-07

    Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA-FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. The SOSTA - net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. ISRCTN94863788--SOSTA--net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

  2. Multicentric osteoid osteoma with a nidus located in the epiphysis

    International Nuclear Information System (INIS)

    Tamam, Cueneyt; Yildirim, Duezguen; Tamam, Muge

    2009-01-01

    We present a 13-year-old girl who was referred to our clinic with a 5-month history of right leg pain relieved by salicylates. Initial CT examination demonstrated a lesion in the posterior tibial cortex in keeping with an osteoid osteoma. This was resected and the diagnosis confirmed by histology. However, her pain recurred 2 weeks after the operation and further imaging identified a further nidus in the epiphysis. We present the imaging findings in this unique case of multicentric osteoid osteoma with one nidus located in the epiphysis. (orig.)

  3. Strategies to diagnose ovarian cancer: new evidence from phase 3 of the multicentre international IOTA study.

    Science.gov (United States)

    Testa, A; Kaijser, J; Wynants, L; Fischerova, D; Van Holsbeke, C; Franchi, D; Savelli, L; Epstein, E; Czekierdowski, A; Guerriero, S; Fruscio, R; Leone, F P G; Vergote, I; Bourne, T; Valentin, L; Van Calster, B; Timmerman, D

    2014-08-12

    To compare different ultrasound-based international ovarian tumour analysis (IOTA) strategies and risk of malignancy index (RMI) for ovarian cancer diagnosis using a meta-analysis approach of centre-specific data from IOTA3. This prospective multicentre diagnostic accuracy study included 2403 patients with 1423 benign and 980 malignant adnexal masses from 2009 until 2012. All patients underwent standardised transvaginal ultrasonography. Test performance of RMI, subjective assessment (SA) of ultrasound findings, two IOTA risk models (LR1 and LR2), and strategies involving combinations of IOTA simple rules (SRs), simple descriptors (SDs) and LR2 with and without SA was estimated using a meta-analysis approach. Reference standard was histology after surgery. The areas under the receiver operator characteristic curves of LR1, LR2, SA and RMI were 0.930 (0.917-0.942), 0.918 (0.905-0.930), 0.914 (0.886-0.936) and 0.875 (0.853-0.894). Diagnostic one-step and two-step strategies using LR1, LR2, SR and SD achieved summary estimates for sensitivity 90-96%, specificity 74-79% and diagnostic odds ratio (DOR) 32.8-50.5. Adding SA when IOTA methods yielded equivocal results improved performance (DOR 57.6-75.7). Risk of Malignancy Index had sensitivity 67%, specificity 91% and DOR 17.5. This study shows all IOTA strategies had excellent diagnostic performance in comparison with RMI. The IOTA strategy chosen may be determined by clinical preference.

  4. Preoperative predictive model for acute kidney injury after elective cardiac surgery: a prospective multicentre cohort study.

    Science.gov (United States)

    Callejas, Raquel; Panadero, Alfredo; Vives, Marc; Duque, Paula; Echarri, Gemma; Monedero, Pablo

    2018-05-11

    Predictive models of CS-AKI include emergency surgery and patients with haemodynamic instability. Our objective was to evaluate the performance of validated predictive models (Thakar and Demirjian) in elective cardiac surgery and to propose a better score in the case of poor performance. A prospective, multicentre, observational study was designed. Data were collected from 942 patients undergoing cardiac surgery, after excluding emergency surgery and patients with an intraaortic balloon pump. The main outcome measure was CS-AKI defined by the composite of requiring dialysis or doubling baseline creatinine values. Both models showed poor discrimination in elective surgery (Thakar's model, AUROC = 0.57, 95% CI = 0.50-0.64 and Demirjian's model, AUROC= 0.64, 95% CI = 0.58-0.71). We generated a new model whose significant independent predictors were: anaemia, age, hypertension, obesity, congestive heart failure, previous cardiac surgery and type of surgery. It classifies patients with scores 0-3 as low risk ( 8 as high risk (>30%) of developing CS-AKI with a statistically significant correlation (p <0.001). Our model reflects acceptable discriminatory ability (AUC = 0.72, 95% CI = 0.66-0.78) which is significantly better than Thakar and Demirjian's models (p<0.01). We developed a new simple predictive model of CS-AKI in elective surgery based on available preoperative information. Our new model is easy to calculate and can be an effective tool for communicating risk to patients and guiding decision-making in the perioperative period. The study requires external validation.

  5. Image acquisition and interpretation criteria for 99mTc-HMPAO-labelled white blood cell scintigraphy: results of a multicentre study

    International Nuclear Information System (INIS)

    Erba, Paola A.; Glaudemans, Andor W.J.M.; Dierckx, Rudi A.J.O.; Veltman, Niels C.; Sollini, Martina; Pacilio, Marta; Galli, Filippo; Signore, Alberto; Sapienza Univ., Rome; Sapienza Univ., Rome

    2014-01-01

    There is no consensus yet on the best protocol for planar image acquisition and interpretation of radiolabelled white blood cell (WBC) scintigraphy. This may account for differences in reported diagnostic accuracy amongst different centres. This was a multicentre retrospective study analysing 235 WBC scans divided into two groups. The first group of scans (105 patients) were acquired with a fixed-time acquisition protocol and the second group (130 patients) were acquired with a decay time-corrected acquisition protocol. Planar images were interpreted both qualitatively and semiquantitatively. Three blinded readers analysed the images. The most accurate imaging acquisition protocol comprised image acquisition at 3 - 4 h and at 20 - 24 h in time mode with acquisition times corrected for isotope decay. Using this protocol, visual analysis had high sensitivity and specificity in the diagnosis of infection. Semiquantitative analysis could be used in doubtful cases, with no cut-off for the percentage increase in radiolabelled WBC over time, as a criterion to define a positive scan. (orig.)

  6. Prognostic indicators in primary plasma cell leukaemia: a multicentre retrospective study of 117 patients.

    Science.gov (United States)

    Jurczyszyn, Artur; Radocha, Jakub; Davila, Julio; Fiala, Mark A; Gozzetti, Alessandro; Grząśko, Norbert; Robak, Paweł; Hus, Iwona; Waszczuk-Gajda, Anna; Guzicka-Kazimierczak, Renata; Atilla, Erden; Mele, Giuseppe; Sawicki, Waldemar; Jayabalan, David S; Charliński, Grzegorz; Szabo, Agoston G; Hajek, Roman; Delforge, Michel; Kopacz, Agnieszka; Fantl, Dorotea; Waage, Anders; Avivi, Irit; Rodzaj, Marek; Leleu, Xavier; Richez, Valentine; Knopińska-Posłuszny, Wanda; Masternak, Anna; Yee, Andrew J; Barchnicka, Agnieszka; Druzd-Sitek, Agnieszka; Guerrero-Garcia, Thomas; Liu, Jieqi; Vesole, David H; Castillo, Jorge J

    2018-03-01

    We report a multicentre retrospective study that analysed clinical characteristics and outcomes in 117 patients with primary plasma cell leukaemia (pPCL) treated at the participating institutions between January 2006 and December 2016. The median age at the time of pPCL diagnosis was 61 years. Ninety-eight patients were treated with novel agents, with an overall response rate of 78%. Fifty-five patients (64%) patients underwent upfront autologous stem cell transplantation (ASCT). The median follow-up time was 50 months (95% confidence interval [CI] 33; 76), with a median overall survival (OS) for the entire group of 23 months (95% CI 15; 34). The median OS time in patients who underwent upfront ASCT was 35 months (95% CI 24·3; 46) as compared to 13 months (95% CI 6·3; 35·8) in patients who did not receive ASCT (P = 0·001). Multivariate analyses identified age ≥60 years, platelet count ≤100 × 10 9 /l and peripheral blood plasma cell count ≥20 × 10 9 /l as independent predictors of worse survival. The median OS in patients with 0, 1 or 2-3 of these risk factors was 46, 27 and 12 months, respectively (P < 0·001). Our findings support the use of novel agents and ASCT as frontline treatment in patients with pPCL. The constructed prognostic score should be independently validated. © 2018 John Wiley & Sons Ltd.

  7. Case report 558: Multicentric Klebsiella pneumoniae (Friedlaenders bacillus) osteomyelitis in sickle cell anemia

    International Nuclear Information System (INIS)

    Malpani, A.R.; Sundaram, M.; Ramani, S.K.

    1989-01-01

    This patient represents a unique combination of multicentric osteomyelitis due to Klebsiella pneumoniae, lesions in the skull, pathological fracture of a long bone and no evidence of pulmonary disease. That Klebsiella pneumoniae osteomyelitis can occur in sickle cell anemia should be considered when such bone changes are seen. The remarkable resolution on conservative management also needs to be noted. (orig./GDG)

  8. Job satisfaction and turnover intention among Iraqi doctors--a descriptive cross-sectional multicentre study.

    Science.gov (United States)

    Ali Jadoo, Saad Ahmed; Aljunid, Syed Mohamed; Dastan, Ilker; Tawfeeq, Ruqiya Subhi; Mustafa, Mustafa Ali; Ganasegeran, Kurubaran; AlDubai, Sami Abdo Radman

    2015-04-19

    During the last two decades, the Iraqi human resources for health was exposed to an unprecedented turnover of trained and experienced medical professionals. This study aimed to explore prominent factors affecting turnover intentions among Iraqi doctors. A descriptive cross-sectional multicentre study was carried out among 576 doctors across 20 hospitals in Iraq using multistage sampling technique. Participants completed a self-administered questionnaire, which included socio-demographic information, work characteristics, the 10-item Warr-Cook-Wall job satisfaction scale, and one question on turnover intention. Descriptive and bivariate and multiple logistic regression analyses were conducted to identify significant factors affecting turnover intentions. More than one half of Iraqi doctors (55.2%) were actively seeking alternative employment. Factors associated with turnover intentions among doctors were low job satisfaction score (odds ratio (OR) = 0.97; 95% confidence interval (CI): 0.95, 0.99), aged 40 years old or less (OR = 2.9; 95% CI: 1.74, 4.75), being male (OR = 4.2; 95% CI: 2.54, 7.03), being single (OR = 5.0; 95% CI: 2.61, 9.75), being threatened (OR = 3.5; 95% CI: 1.80, 6.69), internally displaced (OR = 3.1; 95% CI: 1.43, 6.57), having a perception of unsafe medical practice (OR = 4.1; 95% CI: 1.86, 9.21), working more than 40 h per week, (OR = 2.3; 95% CI: 1.27, 4.03), disagreement with the way manager handles staff (OR = 2.2; 95% CI: 1.19, 4.03), being non-specialist, (OR = 3.9, 95% CI: 2.08, 7.13), and being employed in the government sector only (OR = 2.0; 95% CI: 1.09, 3.82). The high-turnover intention among Iraqi doctors is significantly associated with working and security conditions. An urgent and effective strategy is required to prevent doctors' exodus.

  9. Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Nauth, A. (Aaron); Creek, A.T. (Aaron T.); Zellar, A. (Abby); Lawendy, A.-R. (Abdel-Rahman); Dowrick, A. (Adam); Gupta, A. (Ajay); Dadi, A. (Akhil); A. van Kampen (A.); Yee, A. (Albert); A.C. de Vries (Alexander); de Mol van Otterloo, A. (Alexander); Garibaldi, A. (Alisha); Liew, A. (Allen); McIntyre, A.W. (Allison W.); Prasad, A.S. (Amal Shankar); Romero, A.W. (Amanda W.); Rangan, A. (Amar); Oatt, A. (Amber); Sanghavi, A. (Amir); Foley, A.L. (Amy L.); Karlsten, A. (Anders); Dolenc, A. (Andrea); Bucknill, A. (Andrew); Chia, A. (Andrew); Evans, A. (Andrew); Gong, A. (Andrew); Schmidt, A.H. (Andrew H.); Marcantonio, A.J. (Andrew J.); Jennings, A. (Andrew); Ward, A. (Angela); Khanna, A. (Angshuman); Rai, A. (Anil); Smits, A.B. (Anke B.); Horan, A.D. (Annamarie D.); Brekke, A.C. (Anne Christine); Flynn, A. (Annette); Duraikannan, A. (Aravin); Stødle, A. (Are); van Vugt, A.B. (Arie B.); Luther, A. (Arlene); Zurcher, A.W. (Arthur W.); Jain, A. (Arvind); Amundsen, A. (Asgeir); Moaveni, A. (Ash); Carr, A. (Ashley); Sharma, A. (Ateet); Hill, A.D. (Austin D.); Trommer, A. (Axel); Rai, B.S. (B. Sachidananda); Hileman, B. (Barbara); Schreurs, B. (Bart); Verhoeven, B. (Bart); Barden, B.B. (Benjamin B.); Flatøy, B. (Bernhard); B.I. Cleffken (Berry); Bøe, B. (Berthe); Perey, B. (Bertrand); Hanusch, B.C. (Birgit C.); Weening, B. (Brad); B. Fioole (Bram); Rijbroek, B. (Bram); Crist, B.D. (Brett D.); Halliday, B. (Brett); Peterson, B. (Brett); Mullis, B. (Brian); Richardson, C.G. (C. Glen); Clark, C. (Callum); Sagebien, C.A. (Carlos A.); C. van der Pol (Carmen); Bowler, C. (Carol); Humphrey, C.A. (Catherine A.); Coady, C. (Catherine); Koppert, C.L. (Cees L.); Coles, C. (Chad); Tannoury, C. (Chadi); DePaolo, C.J. (Charles J.); Gayton, C. (Chris); Herriott, C. (Chris); Reeves, C. (Christina); Tieszer, C. (Christina); Dobb, C. (Christine); Anderson, C.G. (Christopher G.); Sage, C. (Claire); Cuento, C. (Claudine); Jones, C.B. (Clifford B.); Bosman, C.H.R. (Coks H.R.); Linehan, C. (Colleen); C.P. van der Hart (Cor P.); Henderson, C. (Corey); Lewis, C.G. (Courtland G.); Davis, C.A. (Craig A.); Donohue, C. (Craig); Mauffrey, C. (Cyril); Sundaresh, D.C. (D. C.); Farrell, D.J. (Dana J.); Whelan, D.B. (Daniel B.); Horwitz, D. (Daniel); Stinner, D. (Daniel); Viskontas, D. (Darius); Roffey, D.M. (Darren M.); Alexander, D. (David); Karges, D.E. (David E.); Hak, D. (David); Johnston, D. (David); Love, D. (David); Wright, D.M. (David M.); Zamorano, D.P. (David P.); Goetz, D.R. (David R.); Sanders, D. (David); Stephen, D. (David); Yen, D. (David); Bardana, D. (Davide); Olakkengil, D.J. (Davy J); Lawson, D. (Deanna); Maddock, D. (Deborah); Sietsema, D.L. (Debra L.); Pourmand, D. (Deeba); D. den Hartog (Dennis); Donegan, D. (Derek); D. Heels-Ansdell (Diane); Nam, D. (Diane); Inman, D. (Dominic); Boyer, D. (Dory); Li, D. (Doug); Gibula, D. (Douglas); Price, D.M. (Dustin M.); Watson, D.J. (Dylan J.); Hammerberg, E.M. (E. Mark); Tan, E.T.C.H. (Edward T.C.H.); E.J.R. de Graaf (Eelco); Vesterhus, E.B. (Elise Berg); Roper, E. (Elizabeth); Edwards, E. (Elton); E.H. Schemitsch (Emil); E.R. Hammacher (Eric); Henderson, E.R. (Eric R.); Whatley, E. (Erica); Torres, E.T. (Erick T.); Vermeulen, E.G.J. (Erik G.J.); Finn, E. (Erin); E.M.M. van Lieshout (Esther); Wai, E.K. (Eugene K.); Bannister, E.R. (Evan R.); Kile, E. (Evelyn); Theunissen, E.B.M. (Evert B.M.); Ritchie, E.D. (Ewan D.); Khan, F. (Farah); Moola, F. (Farhad); Howells, F. (Fiona); F. de Nies (Frank); F.H.W.M. van der Heijden (Frank); de Meulemeester, F.R.A.J. (Frank R.A.J.); F. Frihagen (Frede); Nilsen, F. (Fredrik); Schmidt, G.B. (G. Ben); Albers, G.H.R. (G.H. Robert); Gudger, G.K. (Garland K.); Johnson, G. (Garth); Gruen, G. (Gary); Zohman, G. (Gary); Sharma, G. (Gaurav); Wood, G. (Gavin); G.W.M. Tetteroo (Geert); Hjorthaug, G. (Geir); Jomaas, G. (Geir); Donald, G. (Geoff); Rieser, G.R. (Geoffrey Ryan); Reardon, G. (Gerald); Slobogean, G.P. (Gerard P.); G.R. Roukema (Gert); Visser, G.A. (Gijs A.); Moatshe, G. (Gilbert); Horner, G. (Gillian); Rose, G. (Glynis); Guyatt, G. (Gordon); Chuter, G. (Graham); Etherington, G. (Greg); Rocca, G.J.D. (Gregory J. Della); Ekås, G. (Guri); Dobbin, G. (Gwendolyn); Lemke, H.M. (H. Michael); Curry, H. (Hamish); H. Boxma (Han); Gissel, H. (Hannah); Kreder, H. (Hans); Kuiken, H. (Hans); H.L.F. Brom; Pape, H.-C. (Hans-Christoph); H.M. van der Vis (Harm); Bedi, H. (Harvinder); Vallier, H.A. (Heather A.); Brien, H. (Heather); Silva, H. (Heather); Newman, H. (Heike); H. Viveiros (Helena); van der Hoeven, H. (Henk); Ahn, H. (Henry); Johal, H. (Herman); H. Rijna; Stockmann, H. (Heyn); Josaputra, H.A. (Hong A.); Carlisle, H. (Hope); van der Brand, I. (Igor); I. Dawson (Imro); Tarkin, I. (Ivan); Wong, I. (Ivan); Parr, J.A. (J. Andrew); Trenholm, J.A. (J. Andrew); J.C. Goslings (Carel); Amirault, J.D. (J. David); Broderick, J.S. (J. Scott); Snellen, J.P. (Jaap P.); Zijl, J.A.C. (Jacco A.C.); Ahn, J. (Jaimo); Ficke, J. (James); Irrgang, J. (James); Powell, J. (James); Ringler, J.R. (James R.); Shaer, J. (James); Monica, J.T. (James T.); J. Biert (Jan); Bosma, J. (Jan); Brattgjerd, J.E. (Jan Egil); J.P.M. Frölke (Jan Paul); J.C. Wille (Jan); Rajakumar, J. (Janakiraman); Walker, J.E. (Jane E.); Baker, J.K. (Janell K.); Ertl, J.P. (Janos P.); de Vries, J.P.P.M. (Jean Paul P.M.); Gardeniers, J.W.M. (Jean W.M.); May, J. (Jedediah); Yach, J. (Jeff); Hidy, J.T. (Jennifer T.); Westberg, J.R. (Jerald R.); Hall, J.A. (Jeremy A.); van Mulken, J. (Jeroen); McBeth, J.C. (Jessica Cooper); Hoogendoorn, J. (Jochem); Hoffman, J.M. (Jodi M.); Cherian, J.J. (Joe Joseph); Tanksley, J.A. (John A.); Clarke-Jenssen, J. (John); Adams, J.D. (John D.); Esterhai, J. (John); Tilzey, J.F. (John F.); Murnaghan, J. (John); Ketz, J.P. (John P.); Garfi, J.S. (John S.); Schwappach, J. (John); Gorczyca, J.T. (John T.); Wyrick, J. (John); Rydinge, J. (Jonas); Foret, J.L. (Jonathan L.); Gross, J.M. (Jonathan M.); Keeve, J.P. (Jonathan P.); Meijer, J. (Joost); J.J. Scheepers (Joris J.); Baele, J. (Joseph); O'Neil, J. (Joseph); Cass, J.R. (Joseph R.); Hsu, J.R. (Joseph R.); Dumais, J. (Jules); Lee, J. (Julia); Switzer, J.A. (Julie A.); Agel, J. (Julie); Richards, J.E. (Justin E.); Langan, J.W. (Justin W.); Turckan, K. (Kahn); Pecorella, K. (Kaili); Rai, K. (Kamal); Aurang, K. (Kamran); Shively, K. (Karl); K.J.P. van Wessem; Moon, K. (Karyn); Eke, K. (Kate); Erwin, K. (Katie); Milner, K. (Katrine); K.J. Ponsen (Kees-jan); Mills, K. (Kelli); Apostle, K. (Kelly); Johnston, K. (Kelly); Trask, K. (Kelly); Strohecker, K. (Kent); Stringfellow, K. (Kenya); Kruse, K.K. (Kevin K.); Tetsworth, K. (Kevin); Mitchell, K. (Khalis); Browner, K. (Kieran); Hemlock, K. (Kim); Carcary, K. (Kimberly); Jørgen Haug, K. (Knut); Noble, K. (Krista); Robbins, K. (Kristin); Payton, K. (Krystal); Jeray, K.J. (Kyle J.); Rubino, L.J. (L. Joseph); Nastoff, L.A. (Lauren A.); Leffler, L.C. (Lauren C.); L.P. Stassen (Laurents); O'Malley, L.K. (Lawrence K.); Specht, L.M. (Lawrence M.); L. Thabane (Lehana); Geeraedts, L.M.G. (Leo M.G.); Shell, L.E. (Leslie E.); Anderson, L.K. (Linda K.); Eickhoff, L.S. (Linda S.); Lyle, L. (Lindsey); Pilling, L. (Lindsey); Buckingham, L. (Lisa); Cannada, L.K. (Lisa K.); Wild, L.M. (Lisa M.); Dulaney-Cripe, L. (Liz); L.M.S.J. Poelhekke; Govaert, L. (Lonneke); Ton, L. (Lu); Kottam, L. (Lucksy); L.P.H. Leenen (Luke); Clipper, L. (Lydia); Jackson, L.T. (Lyle T.); Hampton, L. (Lynne); de Waal Malefijt, M.C. (Maarten C.); M.P. Simons; M. van der Elst (Maarten); M.W.G.A. Bronkhorst (Maarten); Bhatia, M. (Mahesh); M.F. Swiontkowski (Marc ); Lobo, M.J. (Margaret J.); Swinton, M. (Marilyn); Pirpiris, M. (Marinis); Molund, M. (Marius); Gichuru, M. (Mark); Glazebrook, M. (Mark); Harrison, M. (Mark); Jenkins, M. (Mark); MacLeod, M. (Mark); M.R. de Vries (Mark); Butler, M.S. (Mark S.); Nousiainen, M. (Markku); van ‘t Riet, M. (Martijne); Tynan, M.C. (Martin C.); Campo, M. (Martin); M.G. Eversdijk (Martin); M.J. Heetveld (Martin); Richardson, M. (Martin); Breslin, M. (Mary); Fan, M. (Mary); Edison, M. (Matt); Napierala, M. (Matthew); Knobe, M. (Matthias); Russ, M. (Matthias); Zomar, M. (Mauri); de Brauw, M. (Maurits); Esser, M. (Max); Hurley, M. (Meghan); Peters, M.E. (Melissa E.); Lorenzo, M. (Melissa); Li, M. (Mengnai); Archdeacon, M. (Michael); Biddulph, M. (Michael); Charlton, M. (Michael); McDonald, M.D. (Michael D.); McKee, M.D. (Michael D.); Dunbar, M. (Michael); Torchia, M.E. (Michael E.); Gross, M. (Michael); Hewitt, M. (Michael); Holt, M. (Michael); Prayson, M.J. (Michael J.); M.J.R. Edwards (Michael); Beckish, M.L. (Michael L.); Brennan, M.L. (Michael L.); Dohm, M.P. (Michael P.); Kain, M.S.H. (Michael S.H.); Vogt, M. (Michelle); Yu, M. (Michelle); M.H.J. Verhofstad (Michiel); Segers, M.J.M. (Michiel J.M.); M.J.M. Segers (Michiel); Siroen, M.P.C. (Michiel P.C.); M.R. Reed (Mike); Vicente, M.R. (Milena R.); M.M.M. Bruijninckx (Milko); Trivedi, M. (Mittal); M. Bhandari (Mohit); Moore, M.M. (Molly M.); Kunz, M. (Monica); Smedsrud, M. (Morten); Palla, N. (Naveen); Jain, N. (Neeraj); Out, N.J.M. (Nico J.M.); Simunovic, N. (Nicole); Simunovic, N. (Nicole); N.W.L. Schep (Niels); Müller, O. (Oliver); Guicherit, O.R. (Onno R.); O.J.F. van Waes (Oscar); Wang, O. (Otis); P. Doornebosch (Pascal); Seuffert, P. (Patricia); Hesketh, P.J. (Patrick J.); Weinrauch, P. (Patrick); Duffy, P. (Paul); Keller, P. (Paul); Lafferty, P.M. (Paul M.); Pincus, P. (Paul); P. Tornetta III (Paul); Zalzal, P. (Paul); McKay, P. (Paula); Cole, P.A. (Peter A.); de Rooij, P.D. (Peter D.); Hull, P. (Peter); Go, P.M.N.Y.M. (Peter M.N.Y.M.); P. Patka (Peter); Siska, P. (Peter); Weingarten, P. (Peter); Kregor, P. (Philip); Stahel, P. (Philip); Stull, P. (Philip); P. Wittich (Philippe); P.A.R. Rijcke (Piet); P.P. Oprel (Pim); Devereaux, P.J. (P. J.); Zhou, Q. (Qi); Lee Murphy, R. (R.); Alosky, R. (Rachel); Clarkson, R. (Rachel); Moon, R. (Raely); Logishetty, R. (Rajanikanth); Nanda, R. (Rajesh); Sullivan, R.J. (Raymond J.); Snider, R.G. (Rebecca G.); Buckley, R.E. (Richard E.); Iorio, R. (Richard); Farrugia, R.J. (Richard J); Jenkinson, R. (Richard); Laughlin, R. (Richard); R.P.R. Groenendijk (Richard); Gurich, R.W. (Richard W.); Worman, R. (Ripley); Silvis, R. (Rob); R. Haverlag (Robert); Teasdall, R.J. (Robert J.); Korley, R. (Robert); McCormack, R. (Robert); Probe, R. (Robert); Cantu, R.V. (Robert V.); Huff, R.B. (Roger B.); R.K.J. Simmermacher; Peters, R. (Rolf); Pfeifer, R. (Roman); Liem, R. (Ronald); Wessel, R.N. (Ronald N.); Verhagen, R. (Ronald); Vuylsteke, R. (Ronald); Leighton, R. (Ross); McKercher, R. (Ross); R.W. Poolman (Rudolf); Miller, R. (Russell); Bicknell, R. (Ryan); Finnan, R. (Ryan); Khan, R.M. (Ryan M.); Mehta, S. (Samir); Vang, S. (Sandy); Singh, S. (Sanjay); Anand, S. (Sanjeev); Anderson, S.A. (Sarah A.); Dawson, S.A. (Sarah A.); Marston, S.B. (Scott B.); Porter, S.E. (Scott E.); Watson, S.T. (Scott T.); S. Festen (Sebastiaan); Lieberman, S. (Shane); Puloski, S. (Shannon); Bielby, S.A. (Shea A.); Sprague, S. (Sheila); Hess, S. (Shelley); MacDonald, S. (Shelley); Evans, S. (Simone); Bzovsky, S. (Sofia); Hasselund, S. (Sondre); Lewis, S. (Sophie); Ugland, S. (Stein); Caminiti, S. (Stephanie); Tanner, S.L. (Stephanie L.); S.M. Zielinski (Stephanie); Shepard, S. (Stephanie); Sems, S.A. (Stephen A.); Walter, S.D. (Stephen D.); Doig, S. (Stephen); Finley, S.H. (Stephen H.); Kates, S. (Stephen); Lindenbaum, S. (Stephen); Kingwell, S.P. (Stephen P.); Csongvay, S. (Steve); Papp, S. (Steve); Buijk, S.E. (Steven E.); S. Rhemrev (Steven); Hollenbeck, S.M. (Steven M.); van Gaalen, S.M. (Steven M.); Yang, S. (Steven); Weinerman, S. (Stuart); Subash, (); Lambert, S. (Sue); Liew, S. (Susan); S.A.G. Meylaerts (Sven); Blokhuis, T.J. (Taco J.); de Vries Reilingh, T.S. (Tammo S.); Lona, T. (Tarjei); Scott, T. (Taryn); Swenson, T.K. (Teresa K.); Endres, T.J. (Terrence J.); Axelrod, T. (Terry); van Egmond, T. (Teun); Pace, T.B. (Thomas B.); Kibsgård, T. (Thomas); Schaller, T.M. (Thomas M.); Ly, T.V. (Thuan V.); Miller, T.J. (Timothy J.); Weber, T. (Timothy); Le, T. (Toan); Oliver, T.M. (Todd M.); T.M. Karsten (Thomas); Borch, T. (Tor); Hoseth, T.M. (Tor Magne); Nicolaisen, T. (Tor); Ianssen, T. (Torben); Rutherford, T. (Tori); Nanney, T. (Tracy); Gervais, T. (Trevor); Stone, T. (Trevor); Schrickel, T. (Tyson); Scrabeck, T. (Tyson); Ganguly, U. (Utsav); Naumetz, V. (V.); Frizzell, V. (Valda); Wadey, V. (Veronica); Jones, V. (Vicki); Avram, V. (Victoria); Mishra, V. (Vimlesh); Yadav, V. (Vineet); Arora, V. (Vinod); Tyagi, V. (Vivek); Borsella, V. (Vivian); W.J. Willems (Jaap); Hoffman, W.H. (W. H.); Gofton, W.T. (Wade T.); Lackey, W.G. (Wesley G.); Ghent, W. (Wesley); Obremskey, W. (William); Oxner, W. (William); Cross, W.W. (William W.); Murtha, Y.M. (Yvonne M.); Murdoch, Z. (Zoe)

    2017-01-01

    textabstractBackground Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled

  10. Creating probabilistic maps of the face network in the adolescent brain: A multi-centre functional MRI study

    International Nuclear Information System (INIS)

    Tahmasebi, Amir M.; Mareckova, Klara; Artiges, Eric; Martinot, Jean-Luc; Banaschewski, Tobias; Barker, Gareth J.; Loth, Eva; Schumann, Gunter; Bruehl, Ruediger; Ittermann, Bernd; Buchel, Christian; Conrod, Patricia J.; Flor, Herta; Strohle, Andreas; Garavan, Hugh; Gallinat, Jurgen; Heinz, Andreas; Poline, Jean-Baptiste; Rietschel, Marcella; Smolka, Michael N.; Paus, Tomas

    2012-01-01

    Large-scale magnetic resonance (MR) studies of the human brain offer unique opportunities for identifying genetic and environmental factors shaping the human brain. Here, we describe a dataset collected in the context of a multi-centre study of the adolescent brain, namely the IMAGEN Study. We focus on one of the functional paradigms included in the project to probe the brain network underlying processing of ambiguous and angry faces. Using functional MR (fMRI) data collected in 1,110 adolescents, we constructed probabilistic maps of the neural network engaged consistently while viewing the ambiguous or angry faces; 21 brain regions responding to faces with high probability were identified. We were also able to address several methodological issues, including the minimal sample size yielding a stable location of a test region, namely the fusiform face area (FFA), as well as the effect of acquisition site (eight sites) and scanner (four manufacturers) on the location and magnitude of the fMRI response to faces in the FFA. Finally, we provided a comparison between male and female adolescents in terms of the effect sizes of sex differences in brain response to the ambiguous and angry faces in the 21 regions of interest. Overall, we found a stronger neural response to the ambiguous faces in several cortical regions, including the fusiform face area, in female (vs. male) adolescents, and a slightly stronger response to the angry faces in the amygdala of male (vs. female) adolescents. (authors)

  11. [Cinacalcet in the management of normocalcaemic secondary hyperparathyroidism after kidney transplantation: one-year follow-up multicentre study].

    Science.gov (United States)

    Torregrosa, Josep V; Morales, Enrique; Díaz, Juan M; Crespo, Josep; Bravo, Juan; Gómez, Gonzalo; Gentil, Miguel A; Rodríguez-Benot, Alberto; Rodríguez-García, Minerva; López-Jiménez, Verónica; Gutiérrez-Dalmau, Álex; Jimeno, Luisa; Pérez-Sáez, M José; Romero, Rafael; Gómez-Alamillo, Carlos

    2014-01-01

    The effect of cinacalcet in patients with persistent secondary hyperparathyroidism (SHPT) after kidney transplantation (RT) has mainly been reported in patients with secondary hypercalcaemia. Our objective was to assess the long-term effect of cinacalcet on patients with a RT and normocalcaemic SHPT. A one-year multicentre, observational, retrospective study that included kidney recipients with SHPT (intact parathyroid hormone [iPTH] >120 pg/ml) and calcium levels within the normal range (8.4-10.2 mg/dl). Patients began treatment with cinacalcet in clinical practice. 32 patients with a mean age (standard deviation [SD]) of 54 (11) years, 56% male, were included in the study. Treatment with cinacalcet began a median of 16 months after RT (median dose of 30 mg/day). Levels of iPTH decreased from a median (P25, P75) of 364 (220, 531) pg/ml at the start of the study to 187 (98, 320) after 6 months (48.6% reduction, P=.001) and to 145 (91, 195) after 12 months (60.2% reduction, P=.001), without there being changes in calcium and phosphorus levels (P=.214 and P=.216, respectively). No changes were observed in kidney function or anti-calcineuric drug levels. 3.1% of patients discontinued cinacalcet due to intolerance and 6.2% due to a lack of efficacy. In patients with normocalcaemic SHPT after RT, cinacalcet improves the control of serum PTH values without causing changes to calcaemia, phosphataemia or kidney function. Cinacalcet showed good tolerability.

  12. The Se.Ko.Ph. study: a European multicentre study on falls in elderly subjects living in residential homes

    Directory of Open Access Journals (Sweden)

    Aladar Bruno Ianes

    2017-05-01

    Full Text Available The aim was to investigate risk factors for falls in elderly people living in residential nursing homes. An observational, prospective, multicentre study was conducted between March 2010 and March 2011 investigating falls in elderly residents living in residential nursing homes (4 Italian¸ 4 French and 5 German nursing homes. A number of risk factors were assessed as well as details of the fall (dynamics, reasons, location and time of occurrence. Differences were observed between the countries related to different nursing practices. Fallers comprised 36.5% of all residents and approximately 40% were injured as a consequence. Six logistic regression models were created to assess which fallrelated variables had the most impact, and showed subjects with faecal incontinence had a lower risk of falling, while subjects afflicted with dementia and visual impairment showed an increased risk of falling. Higher Tinetti scores were found to be related to an increased fall risk. Falls in the elderly occur due to complex interactions between demographic, physical, behavioural and environmental risk factors. Differences between countries in fall rates were seen, probably due to different medical practices, use of aids and restraints, and characteristics of the populations (i.e. the Italian residents tended to be more cognitively impaired and more impaired in balance and gait compared to the French and German residents. There was evidence that subjects with a better clinical status fall more frequently, whereas non-fallers had a worse clinical status and therefore tended to be more bedridden.

  13. [A retrospective, observational and multicentre study on patients with hyperactive bladder on treatment with mirabegron and oxybutinine under usual clinical practice conditions].

    Science.gov (United States)

    Sicras-Mainar, A; Navarro-Artieda, R; Ruiz-Torrejón, A; Saez, M; Coll-de Tuero, G; Sánchez, L

    To evaluate therapeutic persistence, healthcare resources, medical costs and adverse events of oxybutynin and mirabegron treatments in patients with overactive bladder in routine medical practice. An observational, retrospective, multicentre study was carried out using the records of patients attended to in 3 different geographic locations (Barcelona, Girona, Asturias). An analysis was made on the 2 study groups (oxybutynin and mirabegron). Follow-up time was one year. Persistence was defined as the time (months), without discontinuation of the initial treatment, or without change of treatment at least 60 days after the initial prescription. Primary endpoints: comorbidity, healthcare resources used, and adverse events. The data was analysed using the SPSSWIN Program, with a significance of Pbladder had similar persistence with the treatment, lower healthcare costs, but with higher oxybutynin vs. mirabegron adverse reaction rates. Copyright © 2016 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

  14. At-Risk Phenotype of Neurofibromatose-1 Patients: A Multicentre Case-Control Study

    Directory of Open Access Journals (Sweden)

    Ferkal Salah

    2011-07-01

    Full Text Available Abstract Objectives To assess associations between subcutaneous neurofibromas (SC-NFs and internal neurofibromas in patients with neurofibromatosis type 1 (NF-1 and to determine whether the association between SC-NFs and peripheral neuropathy was ascribable to internal neurofibromas. Patients and methods Prospective multicentre case-control study. Between 2005 and 2008, 110 NF-1 adults having two or more SC-NFs were individually matched for age, sex and hospital with 110 controls who had no SC-NF. Patients underwent standardized MRI of the spinal cord, nerve roots and sciatic nerves and an electrophysiological study. Analyses used adjusted multinomial logistic regression (ORa to estimate the risk of the presence of internal neurofibromas or peripheral neuropathies associated with patients presented 2 to 9 SC-NFs, at least 10 SC-NFs as compared to patients without any (referential category. Results Cases had a mean age of 41 (± 13 years; 85 (80% had two to nine SC-NFs and 21 (19% at least ten SC-NFs. SC-NFs were more strongly associated with internal neurofibromas in patients with ten or more SC-NFs than in patients with fewer NF-SCs (e.g., sciatic nerve, aOR = 29.1 [8.5 to 100] vs. 4.3 [2.1 to 9.0]. The association with SC-NFs was stronger for diffuse, intradural, and > 3 cm internal neurofibromas than with other internal neurofibromas. Axonal neuropathy with slowed conduction velocities (SCV was more strongly associated with having at least ten SC-NFs (aOR = 29.9, 5.5 to 162.3 than with having fewer SC-NFs (aOR = 4.4, 0.9 to 22.0. Bivariate analyses showed that the association between axonal neuropathy with SCV and sciatic neurofibromas was mediated by the association between SC-NFs and sciatic neurofibromas. Conclusion The at-risk phenotype of NF-1 patients (i.e. NF-1 patients with SC-NFs is ascribable to associations linking SC-NFs to internal neurofibromas at risk for malignant transformation and to axonal neuropathies with slowed

  15. Masquerade Syndrome of Multicentre Primary Central Nervous System Lymphoma

    Directory of Open Access Journals (Sweden)

    Silvana Guerriero

    2011-01-01

    Full Text Available Purpose. In Italy we say that the most unlucky things can happen to physicians when they get sick, despite the attention of colleagues. To confirm this rumor, we report the sad story of a surgeon with bilateral vitreitis and glaucoma unresponsive to traditional therapies. Methods/Design. Case report. Results. After one year of steroidal and immunosuppressive therapy, a vitrectomy, and a trabeculectomy for unresponsive bilateral vitreitis and glaucoma, MRI showed a multicentre primary central nervous system lymphoma, which was the underlying cause of the masquerade syndrome. Conclusions. All ophthalmologists and clinicians must be aware of masquerade syndromes, in order to avoid delays in diagnosis.

  16. Hypercalcaemic multicentric lymphoma in a dog presenting as clitoromegaly

    Directory of Open Access Journals (Sweden)

    Anthony B. Zambelli

    2013-12-01

    Full Text Available Clitoromegaly is a clinical manifestation of various local and systemic conditions in all species. The external genitalia are a very rare site of primary or metastatic lymphoma in canines, with only one previously-reported case in a dog and only sparse reports in the medical literature. Lymphoma is also very rare in dogs less than four years of age. This account reports on a T-cell multicentric lymphoma in a 16-month-old Basset hound presented primarily for clitoromegaly. The patient survived for 68 days with cyclophosphamide-vincristine-prednisolone therapy. The causes of clitoromegaly in all species, including humans, are tabulated with references.

  17. Standardised multicentre procedure for plasma gonadotrophin radioimmunoassay

    Energy Technology Data Exchange (ETDEWEB)

    Ferguson, K M; Hayes, M; Jeffcoate, S L [Chelsea Hospital for Women, London (UK)

    1982-09-01

    A radioimmunoassay method for the assay of luteinising hormone (LH) and follicle-stimulating hormone (FSH) in serum/plasma has been designed for use in laboratories of varying expertise in the United Kingdom. The major sources of experimental error leading to poor within-laboratory performance and between-laboratory comparability were identified: quality of tracer, use of calibration standards, and separation procedure. A simple rugged kit was designed which was extensively tested first in our laboratory and then in a small multi-centre field trial before being made available. It is now used routinely by 26 health service and research laboratories. The working range of the assays is 1-50 IU/l (LH) and 0.3-16 IU/l (FSH). The between-batch reproducibility was 5-11% (CV) over the dose range 4.8-18 IU/l (LH) and 1.6-15 IU/l (FSH).

  18. Fracture fixation in the operative management of hip fractures (FAITH) : an international, multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Nauth, Aaron; Creek, Aaron T.; Zellar, Abby; Lawendy, Abdel Rahman; Dowrick, Adam; Gupta, Ajay; Dadi, Akhil; van Kampen, Albert; Yee, Albert; de Vries, Alexander C.; de Mol van Otterloo, Alexander; Garibaldi, Alisha; Liew, Allen; McIntyre, Allison W.; Prasad, Amal Shankar; Romero, Amanda W.; Rangan, Amar; Oatt, Amber; Sanghavi, Amir; Foley, Amy L.; Karlsten, Anders; Dolenc, Andrea; Bucknill, Andrew; Chia, Andrew; Evans, Andrew; Gong, Andrew; Schmidt, Andrew H.; Marcantonio, Andrew J.; Jennings, Andrew; Ward, Angela; Khanna, Angshuman; Rai, Anil; Smits, Anke B; Horan, Annamarie D.; Brekke, Anne Christine; Flynn, Annette; Duraikannan, Aravin; Stødle, Are; van Vugt, Arie B.; Luther, Arlene; Zurcher, Arthur W.; Jain, Arvind; Amundsen, Asgeir; Moaveni, Ash; Carr, Ashley; Sharma, Ateet; Hill, Austin D.; Trommer, Axel; Rai, B. Sachidananda; Hileman, Barbara; Schreurs, Bart; Verhoeven, Bart A N; Barden, Benjamin B.; Flatøy, Bernhard; Cleffken, Berry I.; Bøe, Berthe; Perey, Bertrand; Hanusch, Birgit C.; Weening, Brad; Fioole, Bram; Rijbroek, Bram; Crist, Brett D.; Halliday, Brett; Peterson, Brett; Mullis, Brian; Richardson, C. Glen; Clark, Callum; Sagebien, Carlos A.; van der Pol, Carmen C.; Bowler, Carol; Humphrey, Catherine A.; Coady, Catherine; Koppert, Cees L.; Coles, Chad; Tannoury, Chadi; DePaolo, Charles J.; Gayton, Chris; Herriott, Chris; Reeves, Christina; Tieszer, Christina; Dobb, Christine; Anderson, Christopher G.; Sage, Claire; Cuento, Claudine; Jones, Clifford B.; Bosman, Coks H.R.; Linehan, Colleen; van der Hart, Cor P.; Henderson, Corey; Lewis, Courtland G.; Davis, Craig A.; Donohue, Craig; Mauffrey, Cyril; Sundaresh, D. C.; Farrell, Dana J.; Whelan, Daniel B.; Horwitz, Daniel; Stinner, Daniel; Viskontas, Darius; Roffey, Darren M.; Alexander, David; Karges, David E.; Hak, David; Johnston, David; Love, David; Wright, David M.; Zamorano, David P.; Goetz, David R.; Sanders, David; Stephen, David; Yen, David; Bardana, Davide; Olakkengil, Davy J.; Lawson, Deanna; Maddock, Deborah; Sietsema, Debra L.; Pourmand, Deeba; Den Hartog, Dennis; Donegan, Derek; Heels-Ansdell, Diane; Nam, Diane; Inman, Dominic; Boyer, Dory; Li, Doug; Gibula, Douglas; Price, Dustin M.; Watson, Dylan J.; Hammerberg, E. Mark; Tan, Edward C T H; de Graaf, Eelco J.R.; Vesterhus, Elise Berg; Roper, Elizabeth; Edwards, Elton; Schemitsch, Emil H.; Hammacher, Eric R.; Henderson, Eric R.; Whatley, Erica; Torres, Erick T.; Vermeulen, Erik G.J.; Finn, Erin; Van Lieshout, Esther M M; Wai, Eugene K.; Bannister, Evan R.; Kile, Evelyn; Theunissen, Evert B.M.; Ritchie, Ewan D.; Khan, Farah; Moola, Farhad; Howells, Fiona; de Nies, Frank; van der Heijden, Frank H.W.M.; de Meulemeester, Frank R.A.J.; Frihagen, Frede; Nilsen, Fredrik; Schmidt, G. Ben; Albers, G. H.Robert; Gudger, Garland K.; Johnson, Garth; Gruen, Gary; Zohman, Gary; Sharma, Gaurav; Wood, Gavin; Tetteroo, Geert W.M.; Hjorthaug, Geir; Jomaas, Geir; Donald, Geoff; Rieser, Geoffrey Ryan; Reardon, Gerald; Slobogean, Gerard P.; Roukema, Gert R.; Visser, Gijs A.; Moatshe, Gilbert; Horner, Gillian; Rose, Glynis; Guyatt, Gordon; Chuter, Graham; Etherington, Greg; Rocca, Gregory J.Della; Ekås, Guri; Dobbin, Gwendolyn; Lemke, H. Michael; Curry, Hamish; Boxma, Han; Gissel, Hannah; Kreder, Hans; Kuiken, Hans; Brom, Hans L.F.; Pape, Hans Christoph; van der Vis, Harm M.; Bedi, Harvinder; Vallier, Heather A.; Brien, Heather; Silva, Heather; Newman, Heike; Viveiros, Helena; van der Hoeven, Henk; Ahn, Henry; Johal, Herman; Rijna, Herman; Stockmann, Heyn; Josaputra, Hong A.; Carlisle, Hope; van der Brand, Igor; Dawson, Imro; Tarkin, Ivan; Wong, Ivan; Parr, J. Andrew; Trenholm, J. Andrew; Goslings, J Carel; Amirault, J. David; Broderick, J. Scott; Snellen, Jaap P.; Zijl, Jacco A.C.; Ahn, Jaimo; Ficke, James; Irrgang, James; Powell, James; Ringler, James R.; Shaer, James; Monica, James T.; Biert, Jan; Bosma, Jan; Brattgjerd, Jan Egil; Frölke, Jan Paul M.; Wille, Jan; Rajakumar, Janakiraman; Walker, Jane E.; Baker, Janell K.; Ertl, Janos P.; De Vries, Jean-Paul P. M.; Gardeniers, Jean W.M.; May, Jedediah; Yach, Jeff; Hidy, Jennifer T.; Westberg, Jerald R.; Hall, Jeremy A.; van Mulken, Jeroen; McBeth, Jessica Cooper; Hoogendoorn, Jochem M; Hoffman, Jodi M.; Cherian, Joe Joseph; Tanksley, John A.; Clarke-Jenssen, John; Adams, John D.; Esterhai, John; Tilzey, John F.; Murnaghan, John; Ketz, John P.; Garfi, John S.; Schwappach, John; Gorczyca, John T.; Wyrick, John; Rydinge, Jonas; Foret, Jonathan L.; Gross, Jonathan M.; Keeve, Jonathan P.; Meijer, Joost; Scheepers, Joris J.G.; Baele, Joseph; O'Neil, Joseph; Cass, Joseph R.; Hsu, Joseph R.; Dumais, Jules; Lee, Julia; Switzer, Julie A.; Agel, Julie; Richards, Justin E.; Langan, Justin W.; Turckan, Kahn; Pecorella, Kaili; Rai, Kamal; Aurang, Kamran; Shively, Karl; van Wessem, Karlijn; Moon, Karyn; Eke, Kate; Erwin, Katie; Milner, Katrine; Ponsen, Kees Jan; Mills, Kelli; Apostle, Kelly; Johnston, Kelly; Trask, Kelly; Strohecker, Kent; Stringfellow, Kenya; Kruse, Kevin K.; Tetsworth, Kevin; Mitchell, Khalis; Browner, Kieran; Hemlock, Kim; Carcary, Kimberly; Jørgen Haug, Knut; Noble, Krista; Robbins, Kristin; Payton, Krystal; Jeray, Kyle J.; Rubino, L. Joseph; Nastoff, Lauren A.; Leffler, Lauren C.; Stassen, Laurents P.S.; O'Malley, Lawrence K.; Specht, Lawrence M.; Thabane, Lehana; Geeraedts, Leo M.G.; Shell, Leslie E.; Anderson, Linda K.; Eickhoff, Linda S.; Lyle, Lindsey; Pilling, Lindsey; Buckingham, Lisa; Cannada, Lisa K.; Wild, Lisa M.; Dulaney-Cripe, Liz; Poelhekke, Lodewijk M.S.J.; Govaert, Lonneke; Ton, Lu; Kottam, Lucksy; Leenen, Luke P.H.; Clipper, Lydia; Jackson, Lyle T.; Hampton, Lynne; de Waal Malefijt, Maarten C.; Simons, Maarten P.; van der Elst, Maarten; Bronkhorst, Maarten W.G.A.; Bhatia, Mahesh; Swiontkowski, Marc; Lobo, Margaret J.; Swinton, Marilyn; Pirpiris, Marinis; Molund, Marius; Gichuru, Mark; Glazebrook, Mark; Harrison, Mark; Jenkins, Mark; MacLeod, Mark; de Vries, Mark R.; Butler, Mark S.; Nousiainen, Markku; van ‘t Riet, Martijne; Tynan, Martin C.; Campo, Martin; Eversdijk, Martin G.; Heetveld, Martin J.; Richardson, Martin; Breslin, Mary; Fan, Mary; Edison, Matt; Napierala, Matthew; Knobe, Matthias; Russ, Matthias; Zomar, Mauri; de Brauw, Maurits; Esser, Max; Hurley, Meghan; Peters, Melissa E.; Lorenzo, Melissa; Li, Mengnai; Archdeacon, Michael; Biddulph, Michael; Charlton, Michael R; McDonald, Michael D.; McKee, Michael D.; Dunbar, Michael; Torchia, Michael E.; Gross, Michael; Hewitt, Michael; Holt, Michael; Prayson, Michael J.; Edwards, Michael J R; Beckish, Michael L.; Brennan, Michael L.; Dohm, Michael P.; Kain, Michael S.H.; Vogt, Michelle; Yu, Michelle; Verhofstad, Michiel H J; Segers, Michiel J M; Segers, Michiel J M; Siroen, Michiel P.C.; Reed, Mike; Vicente, Milena R.; Bruijninckx, Milko M.M.; Trivedi, Mittal; Bhandari, Mohit; Moore, Molly M.; Kunz, Monica; Smedsrud, Morten; Palla, Naveen; Jain, Neeraj; Out, Nico J.M.; Simunovic, Nicole; Simunovic, Nicole; Schep, Niels W. L.; Müller, Oliver; Guicherit, Onno R.; Van Waes, Oscar J.F.; Wang, Otis; Doornebosch, Pascal G.; Seuffert, Patricia; Hesketh, Patrick J.; Weinrauch, Patrick; Duffy, Paul; Keller, Paul; Lafferty, Paul M.; Pincus, Paul; Tornetta, Paul; Zalzal, Paul; McKay, Paula; Cole, Peter A.; de Rooij, Peter D.; Hull, Peter; Go, Peter M.N.Y.M.; Patka, Peter; Siska, Peter; Weingarten, Peter; Kregor, Philip; Stahel, Philip; Stull, Philip; Wittich, Philippe; de Rijcke, Piet A.R.; Oprel, Pim; Devereaux, P. J.; Zhou, Qi; Lee Murphy, R.; Alosky, Rachel; Clarkson, Rachel; Moon, Raely; Logishetty, Rajanikanth; Nanda, Rajesh; Sullivan, Raymond J.; Snider, Rebecca G.; Buckley, Richard E.; Iorio, Richard; Farrugia, Richard J.; Jenkinson, Richard; Laughlin, Richard; Groenendijk, Richard P R; Gurich, Richard W.; Worman, Ripley; Silvis, Rob; Haverlag, Robert; Teasdall, Robert J.; Korley, Robert; McCormack, Robert; Probe, Robert; Cantu, Robert V.; Huff, Roger B.; Simmermacher, Rogier K J; Peters, Rolf; Pfeifer, Roman; Liem, Ronald; Wessel, Ronald N.; Verhagen, Ronald; Vuylsteke, Ronald J C L M; Leighton, Ross; McKercher, Ross; Poolman, Rudolf W; Miller, Russell; Bicknell, Ryan; Finnan, Ryan; Khan, Ryan M.; Mehta, Samir; Vang, Sandy; Singh, Sanjay; Anand, Sanjeev; Anderson, Sarah A.; Dawson, Sarah A.; Marston, Scott B.; Porter, Scott E.; Watson, Scott T.; Festen, Sebastiaan; Lieberman, Shane; Puloski, Shannon; Bielby, Shea A.; Sprague, Sheila; Hess, Shelley; MacDonald, Shelley; Evans, Simone; Bzovsky, Sofia; Hasselund, Sondre; Lewis, Sophie; Ugland, Stein; Caminiti, Stephanie; Tanner, Stephanie L.; Zielinski, Stephanie M.; Shepard, Stephanie; Sems, Stephen A.; Walter, Stephen D.; Doig, Stephen; Finley, Stephen H.; Kates, Stephen; Lindenbaum, Stephen; Kingwell, Stephen P.; Csongvay, Steve; Papp, Steve; Buijk, Steven E.; Rhemrev, Steven J.; Hollenbeck, Steven M.; van Gaalen, Steven M.; Yang, Steven; Weinerman, Stuart; Lambert, Sue; Liew, Susan; Meylaerts, Sven A.G.; Blokhuis, Taco J.; de Vries Reilingh, Tammo S.; Lona, Tarjei; Scott, Taryn; Swenson, Teresa K.; Endres, Terrence J.; Axelrod, Terry; van Egmond, Teun; Pace, Thomas B.; Kibsgård, Thomas; Schaller, Thomas M.; Ly, Thuan V.; Miller, Timothy J.; Weber, Timothy; Le, Toan; Oliver, Todd M.; Karsten, Tom M.; Borch, Tor; Hoseth, Tor Magne; Nicolaisen, Tor; Ianssen, Torben; Rutherford, Tori; Nanney, Tracy; Gervais, Trevor; Stone, Trevor; Schrickel, Tyson; Scrabeck, Tyson; Ganguly, Utsav; Naumetz, V.; Frizzell, Valda; Wadey, Veronica; Jones, Vicki; Avram, Victoria; Mishra, Vimlesh; Yadav, Vineet; Arora, Vinod; Tyagi, Vivek; Borsella, Vivian; Willems, W. Jaap; Hoffman, W. H.; Gofton, Wade T.; Lackey, Wesley G.; Ghent, Wesley; Obremskey, William; Oxner, William; Cross, William W.; Murtha, Yvonne M.; Murdoch, Zoe

    2017-01-01

    Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we

  19. Feasibility of implementing a practice guideline for fall prevention on geriatric wards: a multicentre study.

    Science.gov (United States)

    Milisen, Koen; Coussement, Joke; Arnout, Hanne; Vanlerberghe, Virginie; De Paepe, Leen; Schoevaerdts, Didier; Lambert, Margareta; Van Den Noortgate, Nele; Delbaere, Kim; Boonen, Steven; Dejaeger, Eddy

    2013-04-01

    About 40% of all adverse events in hospital are falls, but only about one in three Belgian hospitals have a fall prevention policy in place. The implementation of a national practice guideline is urgently needed. This multicentre study aimed to determine the feasibility of a previously developed guideline. SETTING, PARTICIPANTS AND METHOD: Seventeen geriatric wards, selected at random out of 40 Belgian hospitals who agreed to take part in the study, evaluated the fall prevention guideline. After the one-month test period, 49 healthcare workers completed a questionnaire on the feasibility of the guideline. At the end of the study, 512 geriatric patients had been assessed using the practice guideline. The average time spent per patient on case finding, multifactorial assessment and initiating a treatment plan was 5.1, 76.1 and 30.6 min, respectively. For most risk assessments and risk modifications, several disciplines considered themselves as being responsible and capable. The majority (more than 69%) of the respondents judged the practice guideline as useful, but only a small majority (62.3%) believed that the guideline could be successfully integrated into their daily practice over a longer period of time. Barriers for implementation included a large time investment (81.1%), lack of communication between the different disciplines (35.8%), lack of motivation of the patient (34.0%), lack of multidisciplinary teamwork (28.3%), and lack of interest from the hospital management (15.4%). Overall, the guideline was found useful, and for each risk factor (except for visual impairment), at least one discipline felt responsible and capable. Towards future implementation of the guideline, following steps should be considered: division of the risk-factor assessment duties and interventions among different healthcare workers; patient education; appointment of a fall prevention coordinator; development of a fall prevention policy with support from the management of the hospital

  20. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  1. The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC: experiences from a successful ERS Clinical Research Collaboration

    Directory of Open Access Journals (Sweden)

    James D. Chalmers

    2017-09-01

    To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areas To understand some of the key features of successful disease registries To review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC project in the past 5 years To understand the key research priorities identified by EMBARC for the next 5 years

  2. An audiovisual feedback device for compression depth, rate and complete chest recoil can improve the CPR performance of lay persons during self-training on a manikin

    International Nuclear Information System (INIS)

    Krasteva, Vessela; Jekova, Irena; Didon, Jean-Philippe

    2011-01-01

    This study aims to contribute to the scarce data available about the abilities of untrained lay persons to perform hands-only cardio-pulmonary resuscitation (CPR) on a manikin and the improvement of their skills during training with an autonomous CPR feedback device. The study focuses on the following questions: (i) Is there a need for such a CPR training device? (ii) How adequate are the embedded visual feedback and audio guidance for training of lay persons who learn and correct themselves in real time without instructor guidance? (iii) What is the achieved effect of only 3 min of training? This is a prospective study in which 63 lay persons (volunteers) received a debriefing to basic life support and then performed two consecutive 3 min trials of hands-only CPR on a manikin. The pre-training skills of the lay persons were tested in trial 1. The training process with audio guidance and visual feedback from a cardio compression control device (CC-Device) was recorded in trial 2. After initial debriefing for correct chest compressions (CC) with rate 85–115 min −1 , depth 3.8–5.4 cm and complete recoil, in trial 1 the lay persons were able to perform CC without feedback at mean rate 95.9 ± 18.9 min −1 , mean depth 4.13 ± 1.5 cm, with low proportions of 'correct depth', 'correct rate' and 'correct recoil' at 33%, 43%, 87%, resulting in the scarce proportion of 14% for compressions, which simultaneously fulfill the three quality criteria ('correct all'). In trial 2, the training process by the CC-Device was established by the significant improvement of the CC skills until the 60th second of training, when 'correct depth', 'correct rate' and 'correct recoil' attained the plateau of the highest quality at 82%, 90%, 96%, respectively, resulting in 73% 'correct all' compressions within 3 min of training. The training was associated with reduced variance of the mean rate 102.4 ± 4

  3. CFD study of exhaled droplet transmission between occupants under different ventilation strategies in a typical office room

    Energy Technology Data Exchange (ETDEWEB)

    He, Qibin; Gao, Naiping; Zhu, Tong; Wu, Jiazheng [Institute of Refrigeration and Thermal Engineering, School of Mechanical Engineering, Tongji University, Siping Road 1239, Shanghai (China); Niu, Jianlei [Department of Building Services Engineering, The Hong Kong Polytechnic University, Hung Hom, Kowloon (China)

    2011-02-15

    This paper investigated the transmission of respiratory droplets between two seated occupants equipped with one type of personalized ventilation (PV) device using round movable panel (RMP) in an office room. The office was ventilated by three different total volume (TV) ventilation strategies, i.e. mixing ventilation (MV), displacement ventilation (DV), and under-floor air distribution (UFAD) system respectively as background ventilation methods. Concentrations of particles with aerodynamic diameters of 0.8 {mu}m, 5 {mu}m, and 16 {mu}m as well as tracer gas were numerically studied in the Eulerian frame. Two indexes, i.e. intake fraction (IF) and concentration uniformity index R{sub C} were introduced to evaluate the performance of ventilation systems. It was found that without PV, DV performed best concern protecting the exposed manikin from the pollutants exhaled by the polluting manikin. In MV when the exposed manikin opened RMP the inhaled air quality could always be improved. In DV and UFAD application of RMP might sometimes, depending on the personalized airflow rate, increase the exposure of the others to the exhaled droplets of tracer gas, 0.8 {mu}m particles, and 5 {mu}m particles from the infected occupants. Application of PV could reduce R{sub C} for all the three TV systems of 0.8 {mu}m and 5 {mu}m particles. PV enhanced mixing degree of particles under DV and UFAD based conditions much stronger than under MV based ones. PV could increase the average concentration in the occupied zone of the exposed manikin as well as provide clean personalized airflow. Whether inhaled air quality could be improved depended on the balance of pros and cons of PV. (author)

  4. Long-term follow-up of patients undergoing auto-SCT for advanced germ cell tumour: a multicentre cohort study.

    Science.gov (United States)

    Seftel, M D; Paulson, K; Doocey, R; Song, K; Czaykowski, P; Coppin, C; Forrest, D; Hogge, D; Kollmansberger, C; Smith, C A; Shepherd, J D; Toze, C L; Murray, N; Sutherland, H; Nantel, S; Nevill, T J; Barnett, M J

    2011-06-01

    Failure of cisplatin-based chemotherapy in advanced germ cell tumour (GCT) is associated with a poor outcome. High-dose chemotherapy and auto-SCT is one therapeutic option, although the long-term outcome after this procedure is unclear. We conducted a multicentre cohort study of consecutive patients undergoing a single auto-SCT for GCT between January 1986 and December 2004. Of 71 subjects, median follow-up is 10.1 years. OS at 5 years is 44.7% (95% confidence interval (CI) 32.9-56.5%) and EFS is 43.5% (95% CI 31.4-55.1%). There were seven (10%) treatment-related deaths within 100 days of auto-SCT. Three (4.2%) patients developed secondary malignancies. Of 33 relapses, 31 occurred within 2 years of auto-SCT. Two very late relapses were noted 13 and 11 years after auto-SCT. In multivariate analysis, favourable outcome was associated with IGCCC (International Germ Cell Consensus Classification) good prognosis disease at diagnosis, primary gonadal disease and response to salvage chemotherapy. We conclude that auto-SCT results in successful outcome for a relatively large subgroup of patients with high-risk GCT. Late relapses may occur, a finding not previously reported.

  5. A multicentre observational study to evaluate a new tool to assess emergency physicians' non-technical skills.

    Science.gov (United States)

    Flowerdew, Lynsey; Gaunt, Arran; Spedding, Jessica; Bhargava, Ajay; Brown, Ruth; Vincent, Charles; Woloshynowych, Maria

    2013-06-01

    To evaluate a new tool to assess emergency physicians' non-technical skills. This was a multicentre observational study using data collected at four emergency departments in England. A proportion of observations used paired observers to obtain data for inter-rater reliability. Data were also collected for test-retest reliability, observability of skills, mean ratings and dispersion of ratings for each skill, as well as a comparison of skill level between hospitals. Qualitative data described the range of non-technical skills exhibited by trainees and identified sources of rater error. 96 assessments of 43 senior trainees were completed. At a scale level, intra-class coefficients were 0.575, 0.532 and 0.419 and using mean scores were 0.824, 0.702 and 0.519. Spearman's ρ for calculating test-retest reliability was 0.70 using mean scores. All skills were observed more than 60% of the time. The skill Maintenance of Standards received the lowest mean rating (4.8 on a nine-point scale) and the highest mean was calculated for Team Building (6.0). Two skills, Supervision & Feedback and Situational Awareness-Gathering Information, had significantly different distributions of ratings across the four hospitals (ptechnical skills, especially in relation to leadership. The framework of skills may be used to identify areas for development in individual trainees, as well as guide other patient safety interventions.

  6. The prevalence and specific characteristics of hospitalised pressure ulcer patients: A multicentre cross-sectional study.

    Science.gov (United States)

    Zhou, Qing; Yu, Ting; Liu, Yuan; Shi, Ruifen; Tian, Suping; Yang, Chaoxia; Gan, Huaxiu; Zhu, Yanying; Liang, Xia; Wang, Ling; Wu, Zhenhua; Huang, Jinping; Hu, Ailing

    2018-02-01

    To ascertain the pressure ulcer prevalence in secondary and tertiary general hospitals in different areas of Guangdong Province in China and explore the possible risk factors that are related to pressure ulcers. Few multicentre studies have been conducted on pressure ulcer prevalence in Chinese hospitals. A cross-sectional study design was used. Data from a total of 25,264 patients were included in the analysis at 25 hospitals in China. The investigators were divided into two groups. The investigators in group 1 examined the patients' skin. When a pressure ulcer was found, a pressure ulcer assessment form was completed. The investigators in group 2 provided guidance to the nurses, who assessed all patients and completed another questionnaire. A multivariate logistic regression analysis was used to analyse the relationship between the possible risk factors and pressure ulcer. The overall prevalence rate of pressure ulcers in the 25 hospitals ranged from 0%-3.49%, with a mean of 1.26%. The most common stage of the pressure ulcers was stage II (41.4%); most common anatomical locations were sacrum (39.5%) and the feet (16.4%). Braden score (p pressure ulcers from the multivariate logistic regression analysis. The overall prevalence rate of pressure ulcers in Chinese hospitals was lower than that reported in previous investigations. Specific characteristics of pressure ulcer patients were as follows: low Braden score, longer expected length of stay, double incontinence, an ICU and a medical ward, hospital location in the Pearl River Delta, a university hospital and an older patient. The survey could make managers know their prevalence level of pressure ulcers and provide priorities for clinical nurses. © 2017 John Wiley & Sons Ltd.

  7. Multicentric Evaluation of New Commercial Enzyme Immunoassays for the Detection of Immunoglobulin M and Total Antibodies against Hepatitis A Virus▿

    Science.gov (United States)

    Arcangeletti, M. C.; Dussaix, E.; Ferraglia, F.; Roque-Afonso, A. M.; Graube, A.; Chezzi, C.

    2011-01-01

    A multicentric clinical study was conducted on representative sera from 1,738 European and U.S. subjects for the evaluation of new anti-hepatitis A virus enzyme immunoassays from Bio-Rad Laboratories. Comparison with reference DiaSorin S.p.A. tests confirmed the good performance of Bio-Rad assays (99.85% and 99.47% overall agreement in detecting total antibodies and IgM, respectively). PMID:21653739

  8. Work productivity and activity impairment in gastroesophageal reflux disease in Korean full-time employees: a multicentre study.

    Science.gov (United States)

    Shin, Woon Geon; Kim, Heung Up; Kim, Sang Gyun; Kim, Gwang Ha; Shim, Ki-Nam; Kim, Jeong Wook; Kim, Jin Il; Kim, Jae Gyu; Kim, Jae J; Yim, Da-Hae; Park, Sue K; Park, Soo-Heon

    2012-04-01

    The costs of gastroesophageal reflux disease have not been assessed in Asia, even though the prevalence of gastroesophageal reflux disease is gradually increasing. We evaluated work presenteeism and absenteeism as indirect costs of gastroesophageal reflux disease in Korea. This was a cross-sectional and multicentre study using patient-reported outcome instruments. A total of 1009 full-time employees who visited the gastrointestinal department for any reason (281 patients with gastroesophageal reflux disease and 728 controls) were included. Main outcomes were presenteeism and absenteeism measured as work productivity loss and monetary cost per week. Absenteeism and presenteeism were significantly higher in the gastroesophageal reflux disease than the control group (1.49% vs. 0.46%, P=0.0010; 34.13% vs. 9.23%, Pgastroesophageal reflux disease than the control group (33.09% vs. 9.02%; Pgastroesophageal reflux disease group compared with the control group. Assuming average hourly wages of $14.12, the weekly burden of gastroesophageal reflux disease reached $165.07 per person. Gastroesophageal reflux disease was associated with substantial work productivity loss, mainly due to presenteeism rather than absenteeism, in Korean full-time employees. Copyright © 2011 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  9. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

    Directory of Open Access Journals (Sweden)

    Freitag Christine M

    2013-01-01

    Full Text Available Abstract Background Group-based social skills training (SST has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD. To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS compared to treatment as usual (TAU. It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

  10. Case report 446: Multicentric, metachronous, low-grade, sclerosing osteogenic sarcoma

    International Nuclear Information System (INIS)

    McCarthy, E.F.; Tolo, V.T.; Dorfman, H.D.

    1987-01-01

    This case of multicentric osteosarcoma has overlying features of the clinical subgroups described by Amstutz and Mahoney. This 38-year-old woman has survived 6 years with metachronous multifocal osteosarcomas. She presently has at least seven sites of involvement. The lesions are all densely sclerotic and are confined to the axial skeleton. She has had no treatment except for release of compression syndromes. She has no evidence of pulmonary or other visceral metastases. The low grade nature of this type of multifocal osteosarcoma is confirmed by a six year survival in the absence of ablative surgery, radiotherapy or chemotherapy. (orig.)

  11. Risk and protective factors for falls on one level in young children: multicentre case-control study.

    Science.gov (United States)

    Benford, P; Young, B; Coupland, C; Watson, M; Hindmarch, P; Hayes, M; Goodenough, T; Majsak-Newman, G; Kendrick, D

    2015-12-01

    Childhood falls are an important global public health problem, but there is lack of evidence about their prevention. Falls on one level result in considerable morbidity and they are costly to health services. To estimate ORs for falls on one level in children aged 0-4 years for a range of safety behaviours, safety equipment use and home hazards. Multicentre case-control study at hospitals, minor injury units and general practices in and around four UK study centres. Participants included 582 children less than 5 years of age with a medically attended fall injury occurring at home and 2460 controls matched on age, sex, calendar time and study centre. Fall on one level. Cases' most common injuries were bangs on the head (52%), cuts or grazes not needing stitches (29%) or cuts or grazes needing stitches (17%). Comparing cases to community controls in the adjusted analyses, significant findings were observed for only two exposures. Injured children were significantly less likely to live in a household without furniture corner covers (adjusted OR (AOR) 0.72, 95% CI 0.55 to 0.95), or without rugs and carpets firmly fixed to the floor (AOR 0.76, 95% CI 0.59 to 0.98). We did not find any safety practices, use of safety equipment or home hazards associated with a reduced risk of fall on one level. Our findings do not provide evidence to support changes to current injury prevention practice. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  12. Right-to-left shunt and subclinical ischemic brain lesions in Chinese migraineurs: a multicentre MRI study.

    Science.gov (United States)

    Jiang, Xiao-Han; Wang, Si-Bo; Tian, Qian; Zhong, Chi; Zhang, Guan-Ling; Li, Ya-Jie; Lin, Pan; You, Yong; Guo, Rong; Cui, Ying-Hua; Xing, Ying-Qi

    2018-02-14

    Migraine is considered as a risk factor for subclinical brain ischemic lesions, and right-to-left shunt (RLS) is more common among migraineurs. This cross-sectional study assessed the association of RLS with the increased prevalence of subclinical ischemic brain lesions in migraineurs. We enrolled 334 migraineurs from a multicentre study from June 2015 to August 2016. Participants were all evaluated using contrast-enhanced transcranial Doppler, magnetic resonance imaging (MRI), and completed a questionnaire covering demographics, the main risk factors of vascular disease, and migraine status. RLS was classified into four grades (Grade 0 = Negative; Grade I = 1 ≤ microbubbles (MBs) ≤ 10; Grade II = MBs > 10 and no curtain; Grade III = curtain). Silent brain ischemic infarctions (SBI) and white matter hyperintensities (WMHs) were evaluated on MRI. We found no significant differences between migraineurs with RLS and migraineurs without RLS in subclinical ischemic brain lesions.SBI and WMHs did not increase with the size of the RLS(p for trend for SBI = 0.066, p for trend for WMHs = 0.543). Furthermore, curtain RLS in migraineurs was a risk factor for the presence of SBI (p = 0.032, OR = 3.47; 95%CI: 1.12-10.76). There was no association between RLS and the presence of WMHs. Overall, RLS is not associated with increased SBI or WMHs in migraineurs. However, when RLS is present as a curtain pattern, it is likely to be a risk factor for SBIs in migraineurs. No. NCT02425696 ; registered on April 21, 2015.

  13. Quality of closed chest compression on a manikin in ambulance vehicles and flying helicopters with a real time automated feedback.

    Science.gov (United States)

    Havel, Christof; Schreiber, Wolfgang; Trimmel, Helmut; Malzer, Reinhard; Haugk, Moritz; Richling, Nina; Riedmüller, Eva; Sterz, Fritz; Herkner, Harald

    2010-01-01

    Automated verbal and visual feedback improves quality of resuscitation in out-of-hospital cardiac arrest and was proven to increase short-term survival. Quality of resuscitation may be hampered in more difficult situations like emergency transportation. Currently there is no evidence if feedback devices can improve resuscitation quality during different modes of transportation. To assess the effect of real time automated feedback on the quality of resuscitation in an emergency transportation setting. Randomised cross-over trial. Medical University of Vienna, Vienna Municipal Ambulance Service and Helicopter Emergency Medical Service Unit (Christophorus Flugrettungsverein) in September 2007. European Resuscitation Council (ERC) certified health care professionals performing CPR in a flying helicopter and in a moving ambulance vehicle on a manikin with human-like chest properties. CPR sessions, with real time automated feedback as the intervention and standard CPR without feedback as control. Quality of chest compression during resuscitation. Feedback resulted in less deviation from ideal compression rate 100 min(-1) (9+/-9 min(-1), ptime. Applied work was less in the feedback group compared to controls (373+/-448 cm x compression; ptime automated feedback improves certain aspects of CPR quality in flying helicopters and moving ambulance vehicles. The effect of feedback guidance was most pronounced for chest compression rate. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

  14. Laypersons can successfully place supraglottic airways with 3 minutes of training. A comparison of four different devices in the manikin

    Directory of Open Access Journals (Sweden)

    Schälte Gereon

    2011-10-01

    Full Text Available Abstract Introduction Supraglottic airway devices have frequently been shown to facilitate airway management and are implemented in the ILCOR resuscitation algorithm. Limited data exists concerning laypersons without any medical or paramedical background. We hypothesized that even laymen would be able to operate supraglottic airway devices after a brief training session. Methods Four different supraglottic airway devices: Laryngeal Mask Classic (LMA, Laryngeal Tube (LT, Intubating Laryngeal Mask (FT and CobraPLA (Cobra were tested in 141 volunteers recruited in a technical university cafeteria and in a shopping mall. All volunteers received a brief standardized training session. Primary endpoint was the time required to definitive insertion. In a short questionnaire applicants were asked to assess the devices and to answer some general questions about BLS. Results The longest time to insertion was observed for Cobra (31.9 ± 27.9 s, range: 9-120, p 0.05, the LT (1.36 ± 0.61, p Conclusion Laypersons are able to operate supraglottic airway devices in manikin with minimal instruction. Ventilation was achieved with all devices tested after a reasonable time and with a high success rate of > 95%. The use of supraglottic airway devices in first aid and BLS algorithms should be considered.

  15. Image acquisition and interpretation criteria for {sup 99m}Tc-HMPAO-labelled white blood cell scintigraphy: results of a multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Erba, Paola A. [University of Pisa Medical School (Italy). Regional Center of Nuclear Medicine; Glaudemans, Andor W.J.M.; Dierckx, Rudi A.J.O. [University Medical Center Groningen (Netherlands). Dept. of Nuclear Medicine and Molecular Imaging; Veltman, Niels C. [Jeroen Bosch Hospital, ' s-Hertogenbosch (Netherlands). Dept. of Nuclear Medicine; Sollini, Martina [Arcisprdale S. Maria Nuova - IRCCS, Reggio Emilia (Italy). Nuclear Medicine Unit; Pacilio, Marta; Galli, Filippo [Sapienza Univ., Rome (Italy). Nuclear Medicine Unit; Signore, Alberto [University Medical Center Groningen (Netherlands). Dept. of Nuclear Medicine and Molecular Imaging; Sapienza Univ., Rome (Italy). Nuclear Medicine Unit; Sapienza Univ., Rome (Italy). Ospedale S. Andrea Medicina Nucleare

    2014-04-15

    There is no consensus yet on the best protocol for planar image acquisition and interpretation of radiolabelled white blood cell (WBC) scintigraphy. This may account for differences in reported diagnostic accuracy amongst different centres. This was a multicentre retrospective study analysing 235 WBC scans divided into two groups. The first group of scans (105 patients) were acquired with a fixed-time acquisition protocol and the second group (130 patients) were acquired with a decay time-corrected acquisition protocol. Planar images were interpreted both qualitatively and semiquantitatively. Three blinded readers analysed the images. The most accurate imaging acquisition protocol comprised image acquisition at 3 - 4 h and at 20 - 24 h in time mode with acquisition times corrected for isotope decay. Using this protocol, visual analysis had high sensitivity and specificity in the diagnosis of infection. Semiquantitative analysis could be used in doubtful cases, with no cut-off for the percentage increase in radiolabelled WBC over time, as a criterion to define a positive scan. (orig.)

  16. Dosimetry audit for a multi-centre IMRT head and neck trial

    International Nuclear Information System (INIS)

    Clark, Catharine H.; Hansen, Vibeke Nordmark; Chantler, Hannah; Edwards, Craig; James, Hayley V.; Webster, Gareth; Miles, Elizabeth A.; Guerrero Urbano, M. Teresa; Bhide, Shree A.; Bidmead, A. Margaret; Nutting, Christoper M.

    2009-01-01

    Background and purpose: PARSPORT was a multi-centre randomised trial in the UK which compared Intensity-Modulated Radiotherapy (IMRT) and conventional radiotherapy (CRT) for patients with head and neck cancer. The dosimetry audit goals were to verify the plan delivery in participating centres, ascertain what tolerances were suitable for head and neck IMRT trials and develop an IMRT credentialing program. Materials and methods: Centres enrolling patients underwent rigorous quality assurance before joining the trial. Following this each centre was visited for a dosimetry audit, which consisted of treatment planning system tests, fluence verification films, combined field films and dose point measurements. Results: Mean dose point measurements were made at six centres. For the primary planning target volume (PTV) the differences with the planned values for the IMRT and CRT arms were -0.6% (1.8% to -2.4%) and 0.7% (2.0% to -0.9%), respectively. Ninety-four percent of the IMRT fluence films for individual fields passed gamma criterion of 3%/3 mm and 75% of the films for combined fields passed gamma criterion 4%/3 mm (no significant difference between dynamic delivery and step and shoot delivery). Conclusions: This audit suggests that a 3% tolerance could be applied for PTV point doses. For dose distributions tolerances of 3%/3 mm on individual fields and 4%/3 mm for combined fields are proposed for multi-centre head and neck IMRT trials.

  17. The foundation of NCVD PCI Registry: the Malaysia's first multi-centre interventional cardiology project.

    Science.gov (United States)

    Liew, H B; Rosli, M A; Wan Azman, W A; Robaayah, Z; Sim, K H

    2008-09-01

    The National Cardiovascular Database for Percutaneous Coronary Intervention (NCVD PCI) Registry is the first multicentre interventional cardiology project, involving the main cardiac centres in the country. The ultimate goal of NCVD PCI is to provide a contemporary appraisal of PCI in Malaysia. This article introduces the foundation, the aims, methodology, database collection and preliminary results of the first six-month database.

  18. Experimental investigation into the interaction between the human body and room airflow and its effect on thermal comfort under stratum ventilation.

    Science.gov (United States)

    Cheng, Y; Lin, Z

    2016-04-01

    Room occupants' comfort and health are affected by the airflow. Nevertheless, they themselves also play an important role in indoor air distribution. This study investigated the interaction between the human body and room airflow under stratum ventilation. Simplified thermal manikin was employed to effectively resemble the human body as a flow obstacle and/or free convective heat source. Unheated and heated manikins were designed to fully evaluate the impact of the manikin at various airflow rates. Additionally, subjective human tests were conducted to evaluate thermal comfort for the occupants in two rows. The findings show that the manikin formed a local blockage effect, but the supply airflow could flow over it. With the body heat from the manikin, the air jet penetrated farther compared with that for the unheated manikin. The temperature downstream of the manikin was also higher because of the convective effect. Elevating the supply airflow rate from 7 to 15 air changes per hour varied the downstream airflow pattern dramatically, from an uprising flow induced by body heat to a jet-dominated flow. Subjective assessments indicated that stratum ventilation provided thermal comfort for the occupants in both rows. Therefore, stratum ventilation could be applied in rooms with occupants in multiple rows. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. Predictors of subjective quality of life in schizophrenic patients living in the community. A Nordic multicentre study.

    Science.gov (United States)

    Hansson, L; Middelboe, T; Merinder, L; Bjarnason, O; Bengtsson-Tops, A; Nilsson, L; Sandlund, M; Sourander, A; Sørgaard, K W; Vinding, H

    1999-01-01

    As part of a Nordic multi-centre study investigating the life and care situation of community samples of schizophrenic patients the aim of the present part of the study was to examine the relationship between global subjective quality of life and objective life conditions, clinical characteristics including psychopathology and number of needs for care, subjective factors such as satisfaction with different life domains, social network, and self-esteem. A sample of 418 persons with schizophrenia from 10 sites was used. The results of a final multiple regression analysis, explaining 52.3% of the variance, showed that five subjective factors were significantly associated with global subjective quality of life, together with one objective indicator, to have a close friend. No clinical characteristics were associated with global subjective quality of life. The largest part of the variance was explained by satisfaction with health, 36.3% of the variance, and self-esteem, 7.3% of the variance. It is concluded that the actual relationship between objective life conditions and subjectively experienced quality of life still remains unclear. Furthermore, it seems obvious that personality related factors such as self-esteem, mastery and sense of autonomy also play a role in the appraisal of subjective quality of life, which implies that factors like these are important to consider in clinical and social interventions for patients with schizophrenia in order to improve quality of life for these persons.

  20. Preliminary Results of a Multicentre Study of the UBC Rapid Test for Detection of Urinary Bladder Cancer.

    Science.gov (United States)

    Ecke, Thorsten H; Arndt, Christian; Stephan, Carsten; Hallmann, Steffen; Lux, Oliver; Otto, Thomas; Ruttloff, Jürgen; Gerullis, Holger

    2015-05-01

    UBC Rapid is a test detecting fragments of cytokeratins 8 and 18 in urine. These are cytokeratins frequently overexpressed in tumor cells. We present the first results of a multi-centre study using UBC Rapid in patients with bladder cancer and healthy controls. Clinical urine samples from 92 patients with tumors of the urinary bladder (45 low-grade and 47 high-grade tumors) and from 33 healthy controls were used. Urine samples were analyzed by the UBC Rapid point-of-care (POC) system and evaluated both visually and quantitatively using a concile Omega 100 POC reader. For visual evaluation, different thresholds of band intensity for considering a test as positive were applied. Sensitivities and specificities were calculated by contingency analyses. We found that pathological concentrations by UBC Rapid are detectable in urine of patients with bladder cancer. The calculated diagnostic sensitivity of UBC Rapid in urine was 68.1% for high-grade, but only 46.2% for low-grade tumors. The specificity was 90.9%. The area under the curve (AUC) after receiver-operated curve (ROC) analysis was 0.733. Pathological levels of UBC Rapid in urine are higher in patients with bladder cancer in comparison to the control group (pbladder cancer and controls. Further studies with a greater number of patients will show how valuable these results are. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  1. Distribution of causes of maternal mortality during delivery and post-partum: results of an African multicentre hospital-based study.

    Science.gov (United States)

    Thonneau, Patrick F; Matsudai, Tomohiro; Alihonou, Eusèbe; De Souza, Jose; Faye, Ousseynou; Moreau, Jean-Charles; Djanhan, Yao; Welffens-Ekra, Christiane; Goyaux, Nathalie

    2004-06-15

    To assess the maternal mortality ratio in maternity units of reference hospitals in large west African cities, and to describe the distribution of complications and causes of maternal deaths. Prospective descriptive study in twelve reference maternities located in three African countries (Benin, Ivory Coast, Senegal). Data (clinical findings at hospital entry, medical history, complications, type of surgery, vital status of the women at discharge) were collected from obstetrical and surgical files and from admission hospital registers. All cases of maternal deaths were systematically reviewed by African and European staff. Of a total of 10,515 women, 1495 presented a major obstetric complication with dystocia or inappropriate management of the labour phase as the leading cause. Eighty-five maternal deaths were reported, giving a global hospital-based maternal mortality ratio of 800/100,000. Hypertensive disorders were involved in 25/85 cases (29%) and post-partum haemorrhage in 13/85 cases (15%). Relatively few cases (14) of major sepsis were reported, leading to three maternal deaths. The results of this multicentre study confirm the high rates of maternal mortality in maternity units of reference hospitals in large African cities, and in addition to dystocia the contribution of hypertensive disorders and post-partum haemorrhage to maternal deaths.

  2. Study protocol, rationale and recruitment in a European multi-centre randomized controlled trial to determine the efficacy and safety of azithromycin maintenance therapy for 6 months in primary ciliary dyskinesia

    DEFF Research Database (Denmark)

    Kobbernagel, Helene Elgaard; Buchvald, Frederik F; Haarman, Eric G

    2016-01-01

    maintenance therapy in PCD. METHODS: The BESTCILIA trial is a European multi-centre, double-blind, randomized, placebo-controlled, parallel group study. The intervention is tablets of azithromycin 250/500 mg according to body weight or placebo administered three times a week for 6 months. Subjects...... prescribed in other chronic respiratory disorders. Furthermore, the trial will utilize the Lung clearance index and new, PCD-specific quality of life instruments as outcome measures for PCD. Recruitment is hampered by frequent occurrence of Pseudomonas aeruginosa infection, exacerbations at enrolment...

  3. Tissue-Based MRI Intensity Standardization: Application to Multicentric Datasets

    Directory of Open Access Journals (Sweden)

    Nicolas Robitaille

    2012-01-01

    Full Text Available Intensity standardization in MRI aims at correcting scanner-dependent intensity variations. Existing simple and robust techniques aim at matching the input image histogram onto a standard, while we think that standardization should aim at matching spatially corresponding tissue intensities. In this study, we present a novel automatic technique, called STI for STandardization of Intensities, which not only shares the simplicity and robustness of histogram-matching techniques, but also incorporates tissue spatial intensity information. STI uses joint intensity histograms to determine intensity correspondence in each tissue between the input and standard images. We compared STI to an existing histogram-matching technique on two multicentric datasets, Pilot E-ADNI and ADNI, by measuring the intensity error with respect to the standard image after performing nonlinear registration. The Pilot E-ADNI dataset consisted in 3 subjects each scanned in 7 different sites. The ADNI dataset consisted in 795 subjects scanned in more than 50 different sites. STI was superior to the histogram-matching technique, showing significantly better intensity matching for the brain white matter with respect to the standard image.

  4. Exploring venlafaxine pharmacokinetic variability with a phenotyping approach, a multicentric french-swiss study (MARVEL study).

    Science.gov (United States)

    Lloret-Linares, Célia; Daali, Youssef; Chevret, Sylvie; Nieto, Isabelle; Molière, Fanny; Courtet, Philippe; Galtier, Florence; Richieri, Raphaëlle-Marie; Morange, Sophie; Llorca, Pierre-Michel; El-Hage, Wissam; Desmidt, Thomas; Haesebaert, Frédéric; Vignaud, Philippe; Holtzmann, Jerôme; Cracowski, Jean-Luc; Leboyer, Marion; Yrondi, Antoine; Calvas, Fabienne; Yon, Liova; Le Corvoisier, Philippe; Doumy, Olivier; Heron, Kyle; Montange, Damien; Davani, Siamak; Déglon, Julien; Besson, Marie; Desmeules, Jules; Haffen, Emmanuel; Bellivier, Frank

    2017-11-07

    It is well known that the standard doses of a given drug may not have equivalent effects in all patients. To date, the management of depression remains mainly empirical and often poorly evaluated. The development of a personalized medicine in psychiatry may reduce treatment failure, intolerance or resistance, and hence the burden and costs of mood depressive disorders. The Geneva Cocktail Phenotypic approach presents several advantages including the "in vivo" measure of different cytochromes and transporter P-gp activities, their simultaneous determination in a single test, avoiding the influence of variability over time on phenotyping results, the administration of low dose substrates, a limited sampling strategy with an analytical method developed on DBS analysis. The goal of this project is to explore the relationship between the activity of drug-metabolizing enzymes (DME), assessed by a phenotypic approach, and the concentrations of Venlafaxine (VLX) + O-demethyl-venlafaxine (ODV), the efficacy and tolerance of VLX. This study is a multicentre prospective non-randomized open trial. Eligible patients present a major depressive episode, MADRS over or equal to 20, treatment with VLX regardless of the dose during at least 4 weeks. The Phenotype Visit includes VLX and ODV concentration measurement. Following the oral absorption of low doses of omeprazole, midazolam, dextromethorphan, and fexofenadine, drug metabolizing enzymes activity is assessed by specific metabolite/probe concentration ratios from a sample taken 2 h after cocktail administration for CYP2C19, CYP3A4, CYP2D6; and by the determination of the limited area under the curve from the capillary blood samples taken 2-3 and 6 h after cocktail administration for CYP2C19 and P-gp. Two follow-up visits will take place between 25 and 40 days and 50-70 days after inclusion. They include assessment of efficacy, tolerance and observance. Eleven french centres are involved in recruitment, expected to be

  5. Epidemiological multicentre study on the education provided to patients with type 2 diabetes mellitus in the Spanish Health Care System. The Forma2 study.

    Science.gov (United States)

    García-Donaire, J A; Franch-Nadal, J; Rodríguez-Fortúnez, P; Labrador-Barba, E; Orera-Peña, M L; Rodríguez de Miguel, M

    The purpose of the present study was to characterize the education that patients with type 2 diabetes mellitus receive, and to identify differences as regards the presence of insulin therapy or not. This crossover, multicentre and descriptive study involved 1066 Spanish physicians who completed a questionnaire on Internet. The physicians that responded had a mean of 26.0 years of experience in healthcare, and mainly worked in a walk-in clinic in an urban area. Physicians rated the level of patient knowledge about their disease on a 5.0 point-scale. Fifty percent of them indicated that they spent between 15 and 30min in educating patients at the time of diagnosis. Previous control with HbA1c>9%, presence of microvascular complications, and a low socio-cultural level, were factors associated with spending more time in education. This is the first study designed to evaluate the education provided to patients with type 2 diabetes mellitus from Spain. The time spent and the individualization of the education are important factors associated with better long-term control of the disease, and thus with the effectiveness of the clinical management. Copyright © 2017 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

  6. Advanced air distribution for minimizing airborne cross-infection in aircraft cabins

    DEFF Research Database (Denmark)

    Melikov, Arsen Krikor; Dzhartov, Viktor

    2013-01-01

    The performance of personalized ventilation combined with local exhaust at each seat was studied for the purpose of minimizing airborne cross-infection in spaces whose occupants are sedentary, such as transportation environments. Experiments were carried out in a simulated aircraft cabin section (3...... rows, 21 seats). One breathing thermal manikin simulated an infected passenger as a source of pollution, and a second breathing manikin simulated an exposed passenger. The personalized ventilation supplied clean air at 6 or 10 L/s (12.7 of 21.2 cfm) from in front of each manikin's face. Air...... was withdrawn at a rate of 6 or 10 L/s (12.7 or (21.2 cfm) by the local exhaust system, which consisted of two exhaust terminals, one on each side of the head of the infected manikin. The cabin was ventilated with 180 L/s (381 cfm) of fresh air. Freon was mixed with the air exhaled by the infected manikin...

  7. Influence of mask type and mask position on the effectiveness of bag-mask ventilation in a neonatal manikin.

    Science.gov (United States)

    Deindl, Philipp; O'Reilly, Megan; Zoller, Katharina; Berger, Angelika; Pollak, Arnold; Schwindt, Jens; Schmölzer, Georg M

    2014-01-01

    Anatomical face mask with an air cushion rim might be placed accidentally in a false orientation on the newborn's face or filled with various amounts of air during neonatal resuscitation. Both false orientation as well as variable filling may reduce a tight seal and therefore hamper effective positive pressure ventilation (PPV). We aimed to measure the influence of mask type and mask position on the effectiveness of PPV. Twenty neonatal staff members delivered PPV to a modified, leak-free manikin. Resuscitation parameters were recorded using a self-inflatable bag PPV with an Intersurgical anatomical air cushion rim face mask (IS) and a size 0/1 Laerdal round face mask. Three different positions of the IS were tested: correct position, 90° and 180° rotation in reference to the midline of the face. IS masks in each correct position on the face but with different inflation of the air cushion (empty, 10, 20 and 30 mL). Mask leak was similar with mask rotation to either 90° or 180° but significantly increased from 27 (13-73) % with an adequate filled IS mask compared to 52 (16-83) % with an emptied air cushion rim. Anatomical-shaped face mask had similar mask leaks compared to round face mask. A wrongly positioned anatomical-shaped mask does not influence mask leak. Mask leak significantly increased once the air cushion rim was empty, which may cause failure in mask PPV.

  8. Prevalence of β-thalassemia and other haemoglobinopathies in six cities in India: a multicentre study.

    Science.gov (United States)

    Mohanty, D; Colah, R B; Gorakshakar, A C; Patel, R Z; Master, D C; Mahanta, J; Sharma, S K; Chaudhari, U; Ghosh, M; Das, S; Britt, R P; Singh, S; Ross, C; Jagannathan, L; Kaul, R; Shukla, D K; Muthuswamy, V

    2013-01-01

    The population of India is extremely diverse comprising of more than 3,000 ethnic groups who still follow endogamy. Haemoglobinopathies are the commonest hereditary disorders in India and pose a major health problem. The data on the prevalence of β-thalassemias and other haemoglobinopathies in different caste/ethnic groups of India is scarce. Therefore the present multicentre study was undertaken in six cities of six states of India (Maharashtra, Gujarat, West Bengal, Assam, Karnataka and Punjab) to determine the prevalence of haemoglobinopathies in different caste/ethnic groups using uniform methodology. Fifty-six thousand seven hundred eighty individuals (college students and pregnant women) from different caste/ethnic groups were screened. RBC indices were measured on an automated haematology counter while the percentage of HbA(2), HbF and other abnormal Hb variants were estimated by HPLC on the Variant Hemoglobin Testing System. The overall prevalence of β-thalassemia trait was 2.78 % and varied from 1.48 to 3.64 % in different states, while the prevalence of β-thalassemia trait in 59 ethnic groups varied from 0 to 9.3 %. HbE trait was mainly seen in Dibrugarh in Assam (23.9 %) and Kolkata in West Bengal (3.92 %). In six ethnic groups from Assam, the prevalence of HbE trait varied from 41.1 to 66.7 %. Few subjects with δβ-thalassemia, HPFH, HbS trait, HbD trait, HbE homozygous and HbE β-thalassemia as well as HbS homozygous and HbS-β-thalassemia (India.

  9. A multicentre ‘end to end’ dosimetry audit for cervix HDR brachytherapy treatment

    International Nuclear Information System (INIS)

    Palmer, Antony L.; Diez, Patricia; Gandon, Laura; Wynn-Jones, Andrea; Bownes, Peter; Lee, Chris; Aird, Edwin; Bidmead, Margaret; Lowe, Gerry; Bradley, David; Nisbet, Andrew

    2015-01-01

    Purpose: To undertake the first multicentre fully ‘end to end’ dosimetry audit for HDR cervix brachytherapy, comparing planned and delivered dose distributions around clinical treatment applicators, with review of local procedures. Materials and methods: A film-dosimetry audit was performed at 46 centres, including imaging, applicator reconstruction, treatment planning and delivery. Film dose maps were calculated using triple-channel dosimetry and compared to RTDose data from treatment planning systems. Deviations between plan and measurement were quantified at prescription Point A and using gamma analysis. Local procedures were also discussed. Results: The mean difference between planned and measured dose at Point A was −0.6% for plastic applicators and −3.0% for metal applicators, at standard uncertainty 3.0% (k = 1). Isodose distributions agreed within 1 mm over a dose range 2–16 Gy. Mean gamma passing rates exceeded 97% for plastic and metal applicators at 3% (local) 2 mm criteria. Two errors were found: one dose normalisation error and one applicator library misaligned with the imaged applicator. Suggestions for quality improvement were also made. Conclusions: The concept of ‘end to end’ dosimetry audit for HDR brachytherapy has been successfully implemented in a multicentre environment, providing evidence that a high level of accuracy in brachytherapy dosimetry can be achieved

  10. The European I-MOVE Multicentre 2013-2014 Case-Control Study. Homogeneous moderate influenza vaccine effectiveness against A(H1N1)pdm09 and heterogenous results by country against A(H3N2).

    LENUS (Irish Health Repository)

    Valenciano, Marta

    2015-06-04

    In the first five I-MOVE (Influenza Monitoring Vaccine Effectiveness in Europe) influenza seasons vaccine effectiveness (VE) results were relatively homogenous among participating study sites. In 2013-2014, we undertook a multicentre case-control study based on sentinel practitioner surveillance networks in six European Union (EU) countries to measure 2013-2014 influenza VE against medically-attended influenza-like illness (ILI) laboratory-confirmed as influenza. Influenza A(H3N2) and A(H1N1)pdm09 viruses co-circulated during the season.

  11. Impulse control disorder in patients with Parkinson's disease under dopamine agonist therapy: a multicentre study.

    Science.gov (United States)

    Garcia-Ruiz, Pedro J; Martinez Castrillo, Juan Carlos; Alonso-Canovas, Araceli; Herranz Barcenas, Antonio; Vela, Lydia; Sanchez Alonso, Pilar; Mata, Marina; Olmedilla Gonzalez, Nuria; Mahillo Fernandez, Ignacio

    2014-08-01

    Impulse control disorders (ICDs) encompass a wide spectrum of abnormal behaviour frequently found in cases of Parkinson's disease (PD) treated with dopamine agonists (DAs). The main aim of this study was to analyse ICD prevalence with different DAs. We carried out a multicentre transversal study to evaluate the presence of ICDs in patients with PD chronically treated (>6 months) with a single non-ergolinic DA (pramipexole, ropinirole, or rotigotine). Clinical assessment of ICD was performed using the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease. Thirty-nine per cent of patients (91/233) fulfilled the clinical criteria for ICD. The group of patients with ICD symptoms (ICD+) differed from those without ICD symptoms (ICD-) in younger age and type of DA intake. Oral DA treatment (pramipexole and ropinirole) was associated with higher risk of ICDs compared with transdermal DA (rotigotine): 84/197 (42%) patients treated with oral DA developed ICD, versus 7/36 (19%) patients treated with transdermal DA (Fisher's exact text <0.01). In univariate analysis, a younger age (p<0.01), treatment with rasagiline (p<0.05), and especially treatment with an oral DA (pramipexole or ropinirole) (p<0.01) were significantly associated with ICD. Multivariate analysis confirmed that oral DA remained significantly associated with ICD (p: 0.014, OR: 3.14; 1.26-7.83). ICD was significantly associated with the use of the non-ergolinic oral DA (pramipexole and ropinirole) when compared with transdermal non-ergolinic DA (rotigotine). Since pramipexole, ropinirole and rotigotine are non-ergolinic DAs with very similar pharmacodynamic profiles, it is likely that other factors including route of administration (transdermal vs oral) explain the difference in risk of ICD development. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  12. Sensitivity of imaging for multifocal-multicentric breast carcinoma

    Directory of Open Access Journals (Sweden)

    Viale Giuseppe

    2008-09-01

    Full Text Available Abstract Background This retrospective study aims to determine: 1 the sensitivity of preoperative mammography (Mx and ultrasound (US, and re-reviewed Mx to detect multifocal multicentric breast carcinoma (MMBC, defined by pathology on surgical specimens, and 2 to analyze the characteristics of both detected and undetected foci on Mx and US. Methods Three experienced breast radiologists re-reviewed, independently, digital mammography of 97 women with MMBC pathologically diagnosed on surgical specimens. The radiologists were informed of all neoplastic foci, and blinded to the original mammograms and US reports. With regards to Mx, they considered the breast density, number of foci, the Mx characteristics of the lesions and their BI-RADS classification. For US, they considered size of the lesions, BI-RADS classification and US pattern and lesion characteristics. According to the histological size, the lesions were classified as: index cancer, 2nd lesion, 3rd lesion, and 4th lesion. Any pathologically identified malignant foci not previously described in the original imaging reports, were defined as undetected or missed lesions. Sensitivity was calculated for Mx, US and re-reviewed Mx for detecting the presence of the index cancer as well as additional satellite lesions. Results Pathological examination revealed 13 multifocal and 84 multicentric cancers with a total of 303 malignant foci (282 invasive and 21 non invasive. Original Mx and US reports had an overall sensitivity of 45.5% and 52.9%, respectively. Mx detected 83/97 index cancers with a sensitivity of 85.6%. The number of lesions undetected by original Mx was 165/303. The Mx pattern of breasts with undetected lesions were: fatty in 3 (1.8%; scattered fibroglandular density in 40 (24.3%, heterogeneously dense in 91 (55.1% and dense in 31 (18.8% cases. In breasts with an almost entirely fatty pattern, Mx sensitivity was 100%, while in fibroglandular or dense pattern it was reduced to 45

  13. Patient’s satisfaction after 2-piece inflatable penile prosthesis implantation: An Italian multicentric study

    Directory of Open Access Journals (Sweden)

    Giorgio Gentile

    2016-03-01

    Full Text Available Introduction: Penile prosthesis implant represents a valuable solution for pts with severe erectile dysfunction (ED, non-responders to medical management. The aim of our study was to evaluate the satisfaction of patients (pts after 2-pieces inflatable penile prosthesis (IPP. Aim of the study: to evaluate safety, reliability and post-operative patient’s satisfaction after implantation of two-pieces IPP. Materials and Methods: This retrospective multicentric analysis concerns a group of 42 patients undergone 2-pieces IPP implantation from November 2005 to November 2013, in four Centers of proven experience. As a first step, a detailed review of all clinical reports was performed. Secondly, every patient was asked to fill the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS specifically modified, in order to assess their own satisfaction after surgery and, its impact on patient’s quality of sexual life. Results: 42 pts were evaluated (AMS-Ambicor: 28; Coloplast- Excell: 14; mean age, at time of operation: 60,7 years; mean follow up: 27,6 months; etiology of ED: vascular 23,8%, diabetes 19%, La Peyronie D. 7,1%, consequence of radical prostatectomy 31%, consequence of other pelvic surgery 11,9%, spinal trauma 7%. Mean operative time: 117 ± 58 min, mean postoperative hospital stay 3 ± 1,6 days. Post operative short-term complications: 4 pts (9,5%. Post operative long-term complications: 4 pts (9,5%. Long-term functional results (Questionnaire: 71% of pts (30 reported regular use of the prosthesis, at least 1 time/week, the satisfaction was good in 42% of pts (18, quite good in 33,3% (14, quite bad in 2,4% (1, very bad in 7,1% (3, 6 pts (14,4% didn’t answer. Conclusions: 2 pieces IPP appears to be associated with a low complication rate and good satisfaction of pts especially in the elderly. It also assures satisfactory rates of aesthetics and functional results.

  14. Preliminary research on virtual thermal comfort of automobile occupants

    Science.gov (United States)

    Horobet, Tiberiu; Danca, Paul; Nastase, Ilinca; Bode, Florin

    2018-02-01

    Numerical simulation of climate conditions in automotive industry for the study of thermal comfort had become more and more prominent in the last years compared with the classical approach which consists in wind tunnel measurements and field testing, the main advantages being the reduction of vehicle development time and costs. The study presented in this paper is a part of a project intended to evaluate different strategies of cabin ventilation for improving the thermal comfort inside vehicles. A virtual thermal manikin consisting of 24 parts was introduced on the driver seat in a vehicle. A heat load calculated for summer condition in the city of Cluj-Napoca, Romania was imposed as boundary condition. The purpose of this study was to elaborate a virtual thermal manikin suitable for our research, introduction of the manikin inside the vehicle and to examine his influence inside the automobile. The thermal comfort of the virtual manikin was evaluated in terms of temperature and air velocity.

  15. Aprotinin vs. tranexamic acid in isolated coronary artery bypass surgery: A multicentre observational study.

    Science.gov (United States)

    Deloge, Elsa; Amour, Julien; Provenchère, Sophie; Rozec, Bertrand; Scherrer, Bruno; Ouattara, Alexandre

    2017-05-01

    Aprotinin appears to be more efficacious than lysine analogues to reduce bleeding and transfusion of blood products in high-transfusion-risk cardiac surgical patients. However, in isolated coronary artery bypass graft (CABG) surgery, the results from head-to-head trials remain less conclusive. Our objective was to compare the efficacies and safety of aprotinin and tranexamic acid (TXA) in patients undergoing isolated on-pump CABG. A multicentre before-and-after study pooling individual data from published trials and unpublished data from three other databases. Four tertiary care teaching hospitals (Haut-Lévêque Hospital in Bordeaux, Pitié-Salpêtrière Hospital and Bichat-Claude Bernard Hospital in Paris, and Laennec Hospital in Nantes). We included data of 2496 isolated on-pump CABG surgery patients who received either aprotinin between November 2003 and May 2008 (n = 1267) or TXA between November 2007 and November 2013 (n = 1229). The primary outcome was total blood loss within 24 h after operation. Secondary outcomes were transfusion of blood products, reoperation for bleeding, renal replacement therapy, ICU length of stay and in-hospital mortality. Adjusted mean (SEM) 24-h blood loss after surgery [483 (11) vs. 634 (11) ml, P < 0.0001] and the proportion of patients requiring intraoperative blood product transfusion (32.7 vs. 46.5%, P = 0.01) were lower in aprotinin-treated patients. No difference was observed with regard to reoperations for bleeding, renal replacement therapy and in-hospital mortality. However, patients receiving aprotinin had a significantly shorter adjusted ICU length of stay. In patients undergoing isolated CABG, aprotinin was more effective than TXA in reducing postoperative blood loss, and no safety concerns were identified. The benefits of aprotinin should be considered when evaluating the risk of major blood loss and transfusion in patients scheduled for isolated CABG surgery.

  16. Diet and Pre-eclampsia: A Prospective Multicentre Case-Control Study in Ethiopia.

    Science.gov (United States)

    Endeshaw, Mulualem; Abebe, Fantu; Bedimo, Melkamu; Asart, Anemaw

    2015-06-01

    Pre-eclampsia is one of the most commonly encountered hypertensive disorders of pregnancy that accounts for 20-80% of maternal mortality in developing countries, including Ethiopia. For many years, diet has been suggested to play a role in pre-eclampsia. However, the hypotheses have been diverse with inconsistent results across studies, and this has not been studied in Ethiopia. The objective of this study was to determine the effect of dietary habits on the incidence of pre-eclampsia in Bahir Dar, Ethiopia A prospective multicentre unmatched case-control study was conducted among 453 (151 cases and 302 controls) pregnant women attending antepartum or intrapartum care in public health facilities of Bahir Dar City from June to September 2014. The interviewer conducted a face-to-face interview, measured the mid-upper arm circumference (MUAC) and collected the mid-pregnancy haemoglobin level from clinical notes using a standardized and pretested questionnaire. Epi Info 3.5.3 was used for data entry and cleaning, while IBM SPSS Statistics 20 was used for data analysis. Backward stepwise unconditional logistic regression analysis was employed to determine the strength of association of predictive variables with the outcome variable and to control for the effect of confounding variables. A P-value ≤0.05 was considered statistically significant. For every 1-cm increase of MUAC, there was an increase in the incidence rate of pre-eclampsia by a factor of 1.35 (adjusted odds ratio (AOR)=1.35, 95% confidence interval (CI): 1.21, 1.51). A higher incidence of pre-eclampsia was found in women who reported to have consumed coffee daily during pregnancy (AOR=1.78, 95% CI: 1.20, 3.05). Similarly, for women who had anaemia during the first trimester, the incidence of pre-eclampsia was 2.5 times higher than their counterparts (AOR=2.47, 95% CI: 1.12, 7.61). This study also revealed consumption of fruit or vegetables at least three times a week during pregnancy to be protective

  17. PIpelle Prospective ENDOmetrial carcinoma (PIPENDO) study, pre-operative recognition of high risk endometrial carcinoma: a multicentre prospective cohort study

    International Nuclear Information System (INIS)

    Visser, Nicole C. M.; Bulten, Johan; Wurff, Anneke A. M. van der; Boss, Erik A.; Bronkhorst, Carolien M.; Feijen, Harrie W. H.; Haartsen, Joke E.; Herk, Hilde A. D. M. van; Kievit, Ineke M. de; Klinkhamer, Paul J. J. M.; Pijlman, Brenda M.; Snijders, Marc P. M. L.; Vandenput, Ingrid; Vos, M. Caroline; Wit, Peter E. J. de; Poll-Franse, Lonneke V. van de; Massuger, Leon F.A.G.; Pijnenborg, Johanna M. A.

    2015-01-01

    Endometrial carcinoma is the most common gynaecologic malignancy in industrialised countries and the incidence is still rising. Primary treatment is based on preoperative risk classification and consists in most cases of hysterectomy with bilateral salpingo-oophorectomy. In patients with serous and clear cell histology a complete surgical staging is mandatory. However, in routine clinical practice final histology regularly does not correspond with the preoperative histological diagnosis. This results in both over and under treatment. The aim of this multicentre, prospective cohort study is to select a panel of prognostic biomarkers to improve preoperative diagnosis of endometrial carcinoma in order to identify those patients that need extended surgery and/or additional treatment. Additionally, we will determine whether incorporation of cervical cytology and comorbidity could improve this preoperative risk classification. All patients treated for endometrial carcinoma in the participating hospitals from September 2011 till December 2013 are included. Patient characteristics, as well as comorbidity are registered. Patients without preoperative histology, history of hysterectomy and/or endometrial carcinoma or no surgical treatment including hysterectomy are excluded. The preoperative histology and final pathology will be reviewed and compared by expert pathologists. Additional immunohistochemical analysis of IMP3, p53, ER, PR, MLH1, PTEN, beta-catenin, p16, Ki-67, stathmin, ARID1A and L1CAM will be performed. Preoperative histology will be compared with the final pathology results. Follow-up will be at least 24 months to determine risk factors for recurrence and outcome. This study is designed to improve surgical treatment of endometrial carcinoma patients. A total of 432 endometrial carcinoma patients were enrolled between 2011 and 2013. Follow-up will be completed in 2015. Preoperative histology will be evaluated systematically and background endometrium will be

  18. Puberty in perinatal HIV-1 infection: a multicentre longitudinal study of 212 children.

    Science.gov (United States)

    de Martino, M; Tovo, P A; Galli, L; Gabiano, C; Chiarelli, F; Zappa, M; Gattinara, G C; Bassetti, D; Giacomet, V; Chiappini, E; Duse, M; Garetto, S; Caselli, D

    2001-08-17

    To define age at entry into Tanner stages in children with perinatal HIV-1 infection. Multicentre longitudinal study including 212 perinatally HIV-1-infected children (107 girls and 105 boys) followed-up during puberty (from 8 and 9 years onwards in girls and boys, respectively). Healthy children (843 girls and 821 boys) provided reference percentiles. P2 or B2 stages in girls and P2 or G2 stages in boys defined onset of puberty. The cumulative probability [95% confidence limit (CI)] of entry into each stage at different ages was estimated by the Kaplan-Meier product-limit method; differences were evaluated by log rank test. Relationships were tested using the Spearman's rank correlation coefficient. Ages of girls [years (95%CI)] at P2 [12.9 (12.6-13.2)], P3 [13.4 (13.0-13.8)], P4 [14.6 (14.0-15.2)], B2 [12.7 (12.2-13.2)], B3 [13.3 (12.8-14.0)] and B4 [14.6 (14.0-15.2)] stages were > 97th percentile (> or = 21 month delay) of controls. Ages of boys [years (95%CI)] at P2 [12.6 (12.1-13.1)], P3 [13.9 (13.4-14.4)], P4 [14.9 (14.2-15.6)], G2 [12.1 (11.5-12.7)], G3 [13.6 (13.1-14.1)] and G4 [14.9 (14.1-15.7)] stages were at the 75-97th percentiles (< or = 15 month delay). Age at onset of puberty was not related to clinical and immunological condition, antiretroviral treatment, weigh for height and age at onset of severe disease or immune suppression. Perinatal HIV-1 infection interferes with sexual maturation. The mechanisms by which this occurs should be elucidated and intervention strategies designed. Intervention could save much psychological distress, since associated linear growth failure can exacerbate adolescents' feelings of being different and unwell.

  19. Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

    Science.gov (United States)

    Sun, Jing; Yuan, Yao-Zong; Holtmann, Gerald

    2011-12-01

    Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p Itopride was an effective and well tolerated drug in the management of FD in this patient population.

  20. Optimisation of metabolic criteria in the prognostic assessment in patients with lymphoma. A multicentre study.

    Science.gov (United States)

    Del Puig Cózar-Santiago, M; García-Garzón, J R; Moragas-Freixa, M; Soler-Peter, M; Bassa Massanas, P; Sánchez-Delgado, M; Sanchez-Jurado, R; Aguilar-Barrios, J E; Sanz-Llorens, R; Ferrer-Rebolleda, J

    To compare sensitivity, specificity and predictive value of Deauville score (DS) vs. ΔSUVmax in interim-treatment PET (iPET) and end-treatment PET (ePET), in patients with diffuse large B cell lymphoma (DLBCL), Hodgkin lymphoma (HL), and follicular lymphoma (FL). Retrospective longitudinal multicentre study including 138 patients (46 DLBCL, 46 HL, 46 FL), on whom 3 18 F-FDG PET/CT were performed: baseline, iPET, and ePET. Visual (DS) and semi-quantitative (ΔSUVmax) parameters were determined for iPET and ePET. Predictive value was determined in relation to disease-free interval. Statistical analysis. iPET for DLBCL, HL, and FL: 1) sensitivity of DS: 76.92/83.33/61.53%; specificity: 78.78/85/81.81%; 2) sensitivity of ΔSUVmax: 53.84/83.33/61.53%; specificity: 87.87/87.50/78.78%. ePET for DLBCL, HL and FL: 1) sensitivity of DS: 61.53/83.33/69.23%; specificity: 90.90/85/87.87%; 2) sensitivity of ΔSUVmax: 69.23/83.33/69.23%; specificity: 90.90/87.50/84.84%. Predictive assessment. iPET study: in DLBCL, DS resulted in 10.3% recurrence of negative iPET, and 17.1% in ΔSUVmax at disease-free interval; in HL, both parameters showed a 2.8% recurrence of negative iPET; in FL, DS resulted in 15.6% recurrence of negative iPET, and 16.1% in ΔSUVmax, with no statistical significance. ePET study: in DLBCL, DS resulted in 14.3% recurrence of negative ePET, and 11.8% in ΔSUVmax at disease-free interval; in HL and FL, both methods showed 2.8 and 12.5% recurrence in negative ePET, respectively. DS and ΔSUVmax did not show significant differences in DLBCL, HL and FL. Their predictive value also did not show significant differences in HL and FL. In DLBCL, DS was higher in iPET, and ΔSUVmax in ePET. Copyright © 2017 Elsevier España, S.L.U. y SEMNIM. All rights reserved.

  1. Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year

    DEFF Research Database (Denmark)

    Jørgensen, Anette; Stengaard-Pedersen, Kristian; Simonsen, Lars Ole

    2010-01-01

    Objective To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. Methods A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee...... osteoarthritis (clinical and laboratory) and with a Lequesne algofunctional index score (LFI) of 10 or greater. Patients received a hyaluronan product (sodium hyaluronate; Hyalgan) (n= 167) or saline (n= 170) intra-articularly weekly for 5 weeks and were followed up to 1 year. Time to recurrence was the primary...... efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention...

  2. Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year

    DEFF Research Database (Denmark)

    Jørgensen, Anette; Stengaard-Pedersen, Kristian; Simonsen, Ole

    2010-01-01

    OBJECTIVE: To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. METHODS: A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee...... osteoarthritis (clinical and laboratory) and with a Lequesne algofunctional index score (LFI) of 10 or greater. Patients received a hyaluronan product (sodium hyaluronate; Hyalgan) (n=167) or saline (n=170) intra-articularly weekly for 5 weeks and were followed up to 1 year. Time to recurrence was the primary...... the ACR criteria for osteoarthritis of the knee with moderate to severe disease activity (LFI > or = 10), five intra-articular injections of hyaluronan did not improve pain, function, paracetamol consumption or other efficacy parameters 3, 6, 9 and 12 months after the treatment....

  3. Burnout, psychological morbidity and use of coping mechanisms among palliative care practitioners: A multi-centre cross-sectional study.

    Science.gov (United States)

    Koh, Mervyn Yong Hwang; Chong, Poh Heng; Neo, Patricia Soek Hui; Ong, Yew Jin; Yong, Woon Chai; Ong, Wah Ying; Shen, Mira Li Juan; Hum, Allyn Yin Mei

    2015-07-01

    The prevalence of burnout, psychological morbidity and the use of coping mechanisms among palliative care practitioners in Singapore have not been studied. We aimed to study the prevalence of burnout and psychological morbidity among palliative care practitioners in Singapore and its associations with demographic and workplace factors as well as the use of coping mechanisms. This was a multi-centre, cross-sectional study of all the palliative care providers within the public healthcare sector in Singapore. The study was conducted in hospital palliative care services, home hospice and inpatient hospices in Singapore. The participants were doctors, nurses and social workers. The prevalence of burnout among respondents in our study was 91 of 273 (33.3%) and psychological morbidity was 77 (28.2%). Working >60 h per week was significantly associated with burnout (odds ratio: 9.02, 95% confidence interval: 2.3-35.8, p = 0.002) and psychological morbidity (odds ratio: 7.21, 95% confidence interval: 1.8-28.8, p = 0.005). Home hospice care practitioners (41.5%) were more at risk of developing psychological morbidity compared to hospital-based palliative care (17.5%) or hospice inpatient care (26.0%) (p = 0.007). Coping mechanisms like physical well-being, clinical variety, setting boundaries, transcendental (meditation and quiet reflection), passion for one's work, realistic expectations, remembering patients and organisational activities were associated with less burnout. Our results reveal that burnout and psychological morbidity are significant in the palliative care community and demonstrate a need to look at managing long working hours and promoting the use of coping mechanisms to reduce burnout and psychological morbidity. © The Author(s) 2015.

  4. Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology.

    Science.gov (United States)

    Manzoli, Lamberto; La Vecchia, Carlo; Flacco, Maria Elena; Capasso, Lorenzo; Simonetti, Valentina; Boccia, Stefania; Di Baldassarre, Angela; Villari, Paolo; Mezzetti, Andrea; Cicolini, Giancarlo

    2013-09-24

    While electronic cigarettes are forbidden in several countries, their sales are exploding in many others. Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation, very scarce data are available on their efficacy and safety.We describe the protocol of a 5-year multicentric prospective study aimed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking. The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking. From June to December 2013, we will enroll adult smokers of: (EC) e-cigarettes (self-reported inhaling ≥ 50 puffs per week since ≥ 6 months); (TC) traditional cigarettes (≥ 1 per day since ≥ 6 m); (Mixed) both electronic and traditional cigarettes (≥ 1 per day since ≥ 6 m). Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops. Each subject will have to compile a structured questionnaire at enrolment and after 6, 12, 24, 36 and 60 months. The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase, using portable carbon monoxide analyzers. The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes. Secondary outcomes include adherence to e-cigarettes, self-reported adverse events, quality of life, and time to hospital admission for one among cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Admissions will be checked using official discharge data of the Abruzzo Region. A minimum of 500 subjects in each group will be enrolled, for a total of 1500 participants. Cox proportional hazards analysis will be used to calculate

  5. Gram-negative prosthetic joint infection: outcome of a debridement, antibiotics and implant retention approach. A large multicentre study.

    Science.gov (United States)

    Rodríguez-Pardo, D; Pigrau, C; Lora-Tamayo, J; Soriano, A; del Toro, M D; Cobo, J; Palomino, J; Euba, G; Riera, M; Sánchez-Somolinos, M; Benito, N; Fernández-Sampedro, M; Sorli, L; Guio, L; Iribarren, J A; Baraia-Etxaburu, J M; Ramos, A; Bahamonde, A; Flores-Sánchez, X; Corona, P S; Ariza, J

    2014-11-01

    We aim to evaluate the epidemiology and outcome of gram-negative prosthetic joint infection (GN-PJI) treated with debridement, antibiotics and implant retention (DAIR), identify factors predictive of failure, and determine the impact of ciprofloxacin use on prognosis. We performed a retrospective, multicentre, observational study of GN-PJI diagnosed from 2003 through to 2010 in 16 Spanish hospitals. We define failure as persistence or reappearance of the inflammatory joint signs during follow-up, leading to unplanned surgery or repeat debridement>30 days from the index surgery related death, or suppressive antimicrobial therapy. Parameters predicting failure were analysed with a Cox regression model. A total of 242 patients (33% men; median age 76 years, interquartile range (IQR) 68-81) with 242 episodes of GN-PJI were studied. The implants included 150 (62%) hip, 85 (35%) knee, five (2%) shoulder and two (1%) elbow prostheses. There were 189 (78%) acute infections. Causative microorganisms were Enterobacteriaceae in 78%, Pseudomonas spp. in 20%, and other gram-negative bacilli in 2%. Overall, 19% of isolates were ciprofloxacin resistant. DAIR was used in 174 (72%) cases, with an overall success rate of 68%, which increased to 79% after a median of 25 months' follow-up in ciprofloxacin-susceptible GN-PJIs treated with ciprofloxacin. Ciprofloxacin treatment exhibited an independent protective effect (adjusted hazard ratio (aHR) 0.23; 95% CI, 0.13-0.40; pInfection © 2014 European Society of Clinical Microbiology and Infectious Diseases.

  6. A multicentre prospective study of Guillain-Barré syndrome in Japan: a focus on the incidence of subtypes.

    Science.gov (United States)

    Mitsui, Yoshiyuki; Kusunoki, Susumu; Arimura, Kimiyoshi; Kaji, Ryuji; Kanda, Takashi; Kuwabara, Satoshi; Sonoo, Masahiro; Takada, Kazuo

    2015-01-01

    Guillain-Barré Syndrome (GBS) is classified into the two major subtypes; acute inflammatory demyelinating polyneuropathy (AIDP) and acute motor axonal neuropathy (AMAN). Previous studies have suggested that AIDP is predominant and AMAN is rare in Western countries, whereas AMAN is not always uncommon in East Asia. We aimed to clarify the incidence of the subtypes of GBS in Japan. We performed a prospective multicentre survey over 3 years (2007-2010). Clinical and electrophysiological findings were collected from 184 patients with GBS in 23 tertiary neurology institutes. Anti-ganglioside antibodies were measured by ELISA. We also surveyed the incidence of Fisher syndrome (FS). By electrodiagnostic criteria of Ho et al, patients were classified as having AIDP (40%), or AMAN (22%), or unclassified (38%). Anti-GM1 IgG antibodies were found for 47% of AMAN patients, and 18% of AIDP patients (p<0.001). There were no specific regional trends of the electrodiagnosis and anti-GM1 positivity. During the same study period, 79 patients with FS were identified; the percentage of FS cases out of all cases (FS/(GBS+FS)) was 26%. The frequency of GBS patients with the electrodiagnosis of AMAN by single nerve conduction studies is approximately 20% in Japan, and the AMAN pattern is closely associated with anti-GM1 antibodies. The incidence of FS appears to be much higher in Japan than in Western countries. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  7. Transvaginal repair of genital prolapse: preliminary results of a new tension-free vaginal mesh (Prolift technique)--a case series multicentric study.

    Science.gov (United States)

    Fatton, B; Amblard, J; Debodinance, P; Cosson, M; Jacquetin, B

    2007-07-01

    Our goal was to report the preliminary results of a transvaginal mesh repair of genital prolapse using the Prolift system. This retrospective multicentric study includes 110 patients. All patients had a stage 3 (at the hymen) or stage 4 (beyond the hymen) prolapse. Total mesh was used in 59 patients (53.6%), an isolated anterior mesh in 22 patients (20%) and an isolated posterior mesh in 29 patients (26.4%). We report one bladder injury sutured at surgery and two haematomas requiring secondary surgical management. At 3 months, 106 patients were available for follow-up. Mesh exposure occurred in five patients (4.7%), two of them requiring a surgical management. Granuloma without exposure occurred in three patients (2.8%). Failure rate (recurrent prolapse even asymptomatic or low grade symptomatic prolapse) was 4.7%. According to the perioperative and immediate post-operative results, Prolift repair seems to be a safe technique to correct pelvic organ prolapse. Anatomical and functional results must be assessed with a long-term follow-up to confirm the effectiveness and safety of the procedure.

  8. A Multidisciplinary Evaluation of a Web-based eLearning Training Programme for SAFRON II (TROG 13.01): a Multicentre Randomised Study of Stereotactic Radiotherapy for Lung Metastases.

    Science.gov (United States)

    Pham, D; Hardcastle, N; Foroudi, F; Kron, T; Bressel, M; Hilder, B; Chesson, B; Oates, R; Montgomery, R; Ball, D; Siva, S

    2016-09-01

    In technically advanced multicentre clinical trials, participating centres can benefit from a credentialing programme before participating in the trial. Education of staff in participating centres is an important aspect of a successful clinical trial. In the multicentre study of fractionated versus single fraction stereotactic ablative body radiotherapy in lung oligometastases (TROG 13.01), knowledge transfer of stereotactic ablative body radiotherapy techniques to the local multidisciplinary team is intended as part of the credentialing process. In this study, a web-based learning platform was developed to provide education and training for the multidisciplinary trial teams at geographically distinct sites. A web-based platform using eLearning software consisting of seven training modules was developed. These modules were based on extracranial stereotactic theory covering the following discrete modules: Clinical background; Planning technique and evaluation; Planning optimisation; Four-dimensional computed tomography simulation; Patient-specific quality assurance; Cone beam computed tomography and image guidance; Contouring organs at risk. Radiation oncologists, medical physicists and radiation therapists from hospitals in Australia and New Zealand were invited to participate in this study. Each discipline was enrolled into a subset of modules (core modules) and was evaluated before and after completing each module. The effectiveness of the eLearning training will be evaluated based on (i) knowledge retention after participation in the web-based training and (ii) confidence evaluation after participation in the training. Evaluation consisted of a knowledge test and confidence evaluation using a Likert scale. In total, 130 participants were enrolled into the eLearning programme: 81 radiation therapists (62.3%), 27 medical physicists (20.8%) and 22 radiation oncologists (16.9%). There was an average absolute improvement of 14% in test score (P 4 weeks) after

  9. A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial

    NARCIS (Netherlands)

    Leontjevas, R.; Gerritsen, D.L.; Smalbrugge, M.; Teerenstra, S.; Vernooij-Dassen, M.J.F.J.; Koopmans, R.T.C.M.

    2013-01-01

    BACKGROUND: Depression in nursing-home residents is often under-recognised. We aimed to establish the effectiveness of a structural approach to its management. METHODS: Between May 15, 2009, and April 30, 2011, we undertook a multicentre, stepped-wedge cluster-randomised trial in four provinces of

  10. Methods of evaluating protective clothing relative to heat and cold stress: thermal manikin, biomedical modeling, and human testing.

    Science.gov (United States)

    O'Brien, Catherine; Blanchard, Laurie A; Cadarette, Bruce S; Endrusick, Thomas L; Xu, Xiaojiang; Berglund, Larry G; Sawka, Michael N; Hoyt, Reed W

    2011-10-01

    Personal protective equipment (PPE) refers to clothing and equipment designed to protect individuals from chemical, biological, radiological, nuclear, and explosive hazards. The materials used to provide this protection may exacerbate thermal strain by limiting heat and water vapor transfer. Any new PPE must therefore be evaluated to ensure that it poses no greater thermal strain than the current standard for the same level of hazard protection. This review describes how such evaluations are typically conducted. Comprehensive evaluation of PPE begins with a biophysical assessment of materials using a guarded hot plate to determine the thermal characteristics (thermal resistance and water vapor permeability). These characteristics are then evaluated on a thermal manikin wearing the PPE, since thermal properties may change once the materials have been constructed into a garment. These data may be used in biomedical models to predict thermal strain under a variety of environmental and work conditions. When the biophysical data indicate that the evaporative resistance (ratio of permeability to insulation) is significantly better than the current standard, the PPE is evaluated through human testing in controlled laboratory conditions appropriate for the conditions under which the PPE would be used if fielded. Data from each phase of PPE evaluation are used in predictive models to determine user guidelines, such as maximal work time, work/rest cycles, and fluid intake requirements. By considering thermal stress early in the development process, health hazards related to temperature extremes can be mitigated while maintaining or improving the effectiveness of the PPE for protection from external hazards.

  11. Misoprostol for cervical priming prior to hysteroscopy in postmenopausal and premenopausal nulliparous women; a multicentre randomised placebo controlled trial

    NARCIS (Netherlands)

    Tasma, M L; Louwerse, M D; Hehenkamp, W J; Geomini, P M; Bongers, M Y; Veersema, S; van Kesteren, P J; Tromp, E; Huirne, J A; Graziosi, G C

    OBJECTIVE: To evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women. DESIGN: Randomised multicentre double-blind placebo controlled trial. SETTING: Two Dutch teaching hospitals and one Dutch university medical

  12. Possible Association of Multicentric Castleman's Disease with Autoimmune Lymphoproliferative Syndrome

    Directory of Open Access Journals (Sweden)

    Hiroyuki Minemura

    2018-04-01

    Full Text Available Multicentric Castleman's disease (MCD is lymphoproliferative disorder characterized by systemic inflammatory symptoms such as fever and weight loss. Human herpes virus-8 (HHV-8 is thought to be a causable pathogen in all HIV-positive and some HIV-negative MCD patients. Furthermore, the term idiopathic MCD (iMCD was recently proposed to represent a group of HIV-negative and HHV-8-negative patients with unknown etiologies. Although the international diagnostic criteria for iMCD require exclusion of infection-related disorders, autoimmune/autoinflammatory diseases and malignant/lymphoproliferative disorders to make an iMCD diagnosis, the relationships and differences between these disorders and MCD have not yet been clarified. We recently reported the first case of MCD with autoimmune lymphoproliferative syndrome (ALPS. Although ALPS was included in the iMCD exclusion criteria as an autoimmune/autoinflammatory disease according to the international diagnostic criteria, there is a lack of evidence on the association between MCD and ALPS. In this study, we review the recent understanding of MCD and discuss the possible association between MCD with ALPS.

  13. Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study.

    Science.gov (United States)

    Friedl, Alexander; Mühlstädt, Sandra; Zachoval, Roman; Giammò, Alessandro; Kivaranovic, Danijel; Rom, Maximilian; Fornara, Paolo; Brössner, Clemens

    2017-05-01

    To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS ® , Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting. In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

  14. Management of SPN in France. Pathways for definitive diagnosis of solitary pulmonary nodule: a multicentre study in 18 French districts

    International Nuclear Information System (INIS)

    Alzahouri, Kazem; Velten, Michel; Arveux, Patrick; Woronoff-Lemsi, Marie-Christine; Jolly, Damien; Guillemin, Francis

    2008-01-01

    The process of diagnosis and management of solitary pulmonary nodules (SPNs) between 1 and 3 cm is not standardized. This multicentre study investigated how diagnosis of newly discovered SPNs is managed in routine practice. We examined 11,515 radiology reports of patients undergoing chest computed tomography (CT) at all 76 radiology centres in 18 French administrative districts covering 8,220,000 people. Information on diagnostic procedures and treatment administered from discovery to definitive diagnosis of SPN was collected prospectively. We identified 152 cases of newly diagnosed SPNs. Follow-up was complete for 112 patients. The median number of diagnostic tests was 4 and the mean time to diagnosis was 41.4 days. Marked variability was observed in the sequence of diagnostic tests, and 8 diagnostic pathways were identified. Patients' characteristics and radiological features of SPNs influenced the number of tests performed. Referral by specialist, history of smoking and spiculated SPN predicted the performance of at least one invasive procedure (P < 0.01). Definitive diagnosis was a malignant disease in 30 patients (26%). The diagnosis of SPN is a complex process that physicians approach in markedly different ways. Implementing practice guidelines for managing the diagnosis of SPN requires clarification

  15. Morbidity and mortality in a large series of surgical patients with pulmonary metastases of colorectal carcinoma: a prospective multicentre Spanish study (GECMP-CCR-SEPAR).

    Science.gov (United States)

    Rodríguez-Fuster, Alberto; Belda-Sanchis, José; Aguiló, Rafael; Embun, Raul; Mojal, Sergio; Call, Sergi; Molins, Laureano; Rivas de Andrés, Juan José

    2014-04-01

    Little information is available on postoperative morbidity and mortality after pulmonary metastasectomy. We describe the postoperative morbidity and mortality in a large multicentre series of patients after a first surgical procedure for pulmonary metastases of colorectal carcinoma (CRC) and identify the pre- and intraoperative variables influencing the clinical outcome. A prospective, observational and multicentre study was conducted. Data were collected from March 2008 to February 2010. Patients were grouped into Groups A and B according to the presence or absence of postoperative complications. Variables in both groups were compared by univariate and multivariate analyses. P-values of <0.05 were considered statistically significant. A total of 532 patients (64.5% males) from 32 hospitals were included. The mean (SD) ages of both study groups were similar [68 (10) vs 67 (10) years, P = NS). A total of 1050 lung resections were performed (90% segmentectomies or wedge, n = 946 and 10% lobectomies or greater, n = 104). Group A included 83 (15.6%) patients who developed a total of 100 complications. These included persistent air leaks in 18, atelectasis in 13, pneumonia in 13, paralytic ileum in 12, arrhythmia in 9, acute respiratory distress syndrome in 4 and miscellanea in 31. Reoperation was performed in 5 (0.9%) patients due to persistent air leaks in 4 and lung ischaemia in 1. The mortality rate was 0.4% (n = 2). Causes of death were sepsis in 1 patient and ventricular fibrillation in 1. In the multivariate analysis, lobectomy or greater lung resection [odds ration (OR) 1.9, 95% confidence interval (95% CI) 1.04-3.3, P = 0.03], respiratory co-morbidity (OR 2.3, 95% CI 1.1-4.6, P = 0.01) and cardiovascular co-morbidity (OR 2, 95% CI 1-3.8, P = 0.02) were independent risk factors for postoperative morbidity. Video-assisted surgery vs thoracotomy showed a protective effect (OR 0.3, 95% CI 0.1-0.8, P = 0.01). The first episode of lung surgery for pulmonary

  16. Early Lupus Project - A multicentre Italian study on systemic lupus erythematosus of recent onset.

    Science.gov (United States)

    Sebastiani, G D; Prevete, I; Piga, M; Iuliano, A; Bettio, S; Bortoluzzi, A; Coladonato, L; Tani, C; Spinelli, F R; Fineschi, I; Mathieu, A

    2015-10-01

    Systemic lupus erythematosus (SLE) is an autoimmune disease with a high degree of variability at onset that is problematic for a correct and prompt diagnosis. We undertook this project with the purpose of collecting an inception cohort of Italian patients with recent-onset SLE, in order to obtain information on the main clinical and serological characteristics at the beginning of the disease. In this first report we describe the characteristics of this cohort at study entry. All patients with a diagnosis of SLE (1997 ACR criteria) and a disease duration less than 12 months were consecutively enrolled between 1 January 2012 and 31 December 2013 in a multicentre prospective study. Information on clinical and serological characteristics at study entry and then every six months was collected into a specific electronic database. Statistical analysis was performed by means of the Openstat program. Among 122 patients enrolled (103 F) 94.3% were Caucasians. Mean age (SD) of patients at study entry was 37.3 (14.3) years, mean age at disease onset was 34.8 (14.3) years, mean age at diagnosis was 36.9 (14.3) years, and mean disease duration was 2.9 (3.9) months. The frequency of the manifestations included in the 1997 ACR criteria was as follows: ANA 97.5%, immunologic disorders (anti-dsDNA, anti-Sm, antiphospholipid antibodies) 85.2%, arthritis 61.8%, haematologic disorders 55.7%, malar rash 31.1%, photosensitivity 29.5%, serositis 27%, renal disorders 27%, oral/nasal ulcers 11.5%, neurologic disorders 8.2%, and discoid rash 5.7%. The cumulative frequency of mucocutaneous symptoms was 77.8%. At enrolment, autoantibody frequency was: ANA 100%, anti-dsDNA 83.6%, anti-SSA 28%, anticardiolipin 24.5%, anti-nRNP 20.4%, anti-beta2GPI 17.2%, lupus anticoagulant 16.3%, anti-Sm 16%, and anti-SSB 13.1%. In this paper we describe the main clinical and serological characteristics of an Italian inception cohort of patients with recent-onset SLE. At disease onset, mucocutaneous

  17. Validation of the German version of the patient activation measure 13 (PAM13-D in an international multicentre study of primary care patients.

    Directory of Open Access Journals (Sweden)

    Katja Brenk-Franz

    Full Text Available The patients' active participation in their medical care is important for patients with chronic diseases. Measurements of patient activation are needed for studies and in clinical practice. This study aims to validate the Patient Activation Measure 13 (PAM13-D in German-speaking primary care patients. This international cross-sectional multicentre study enrolled consecutively patients from primary care practices in three German-speaking countries: Germany, Austria, and Switzerland. Patients completed the PAM13-D questionnaire. General Self-Efficacy scale (GSE was used to assess convergent validity. Furthermore Cronbach's alpha was performed to assess internal consistency. Exploratory factor analysis was used to evaluate the underlying factor structure of the items. We included 508 patients from 16 primary care practices in the final analysis. Results were internally consistent, with a Cronbach's alpha of 0.84. Factor analysis revealed one major underlying factor. The mean values of the PAM13-D correlated significantly (r = 0.43 with those of the GSE. The German PAM13 is a reliable and valid measure of patient activation. Thus, it may be useful in primary care clinical practice and research.

  18. Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case–control study in the UK

    Science.gov (United States)

    Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

    2014-01-01

    Objective Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the UK in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. Design A prospective multicentre case–control study was conducted at six UK hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Methods Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Results Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. Conclusions This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. PMID:24687130

  19. Multicentric lymphoma in a giant anteater (Myrmecophaga tridactyla).

    Science.gov (United States)

    Sanches, Adrien W D; Werner, Pedro R; Margarido, Tereza C C; Pachaly, Jose R

    2013-03-01

    Neoplastic disease is not well documented in giant anteaters. This report describes a disseminated lymphoma in an adult male giant anteater (Myrmecophaga tridactyla) from the City Zoo of Curitiba, State of Paraná, Brazil. No clinical signs were noticed before its death, except for a slight inappetence. At postmortem examination, pale white to yellow, variably sized nodules infiltrated the heart, liver, and intestinal lymph nodes. Histologically, two distinct cell populations were present in the nodular lesions: one characterized by smaller cells, primarily lymphocytic in nature, and another characterized by larger rounded cells with loose chromatin and frequently indented nuclei resembling histiocytes. Giant binucleated cells were occasionally observed. Mitotic figures numbered 2-3 mitotic figures/x400 field. Both cellular populations presented with moderate pleomorphism, large nuclei, a high nucleus-to-cytoplasm ratio, distinct nucleoli, and coarse nuclear chromatin. The neoplasia was classified as a form of multicentric lymphohistiocytic lymphoma (Rappaport Classification) and as an intermediate grade lymphoma (National Cancer Institute Working Formulation).

  20. Simulation-based team training for multi-professional obstetric care teams to improve patient outcome : a multicentre, cluster randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

    OBJECTIVE: To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. DESIGN: Multicentre, open, cluster randomised controlled trial. SETTING: Obstetric units in the Netherlands. POPULATION: Women with a singleton pregnancy beyond 24 weeks of

  1. Erectile dysfunction and quality of life in men receiving methadone or buprenorphine maintenance treatment. A cross-sectional multicentre study.

    Directory of Open Access Journals (Sweden)

    Fabio Lugoboni

    Full Text Available Erectile dysfunction (ED is common among men on opioid replacement therapy (ORT, but most previous studies exploring its prevalence and determinants yielded contrasting findings. Moreover, the impact of ED on patients' quality of life (QoL has been seldom explored.To explore the prevalence and determinants of ED in men on ORT, and the impact on QoL.In a multicentre cross-sectional study, we recruited 797 consecutive male patients on methadone and buprenorphine treatment, collected data on demographic, clinical, and psychopathological factors, and explored their role as predictors of ED and QoL through univariate and multivariate analysis. ED severity was assessed with a self-assessment questionnaire.Nearly half of patients in our sample were sexually inactive or reported some degree of ED. Some demographic, clinical and psychopathological variables significantly differed according to the presence or absence of ED. Multivariate regression analysis indicated that age, employment, smoke, psychoactive drugs, opioid maintenance dosage, and severity of psychopathological factors significantly influenced the risk and severity of ED. QoL was worse in patients with ED and significantly correlated with ED severity. Age, education, employment, opioid maintenance dosage, ED score, and severity of psychopathology significantly influenced QoL in the multivariate analysis.ED complaints can be explored in male opioid users on ORT through a simple and quick self-assessment tool. ED may have important effects on emotional and social well-being, and may affect outcome.

  2. Epidemiological and clinical characteristics and behaviours of individuals with newly diagnosed HIV infection: a multicentre study in north Italy.

    Science.gov (United States)

    Casari, S; Suligoi, B; Camoni, L; Pavan, A; Macchi, L; Capelli, M; Paraninfo, G; Compostella, S; Castelli, F; Carosi, G; Donato, F

    2012-12-01

    We aimed to investigate socio-demographic, clinical and epidemiological characteristics and behaviours of subjects with new HIV diagnosis. We carried out a multi-centre cross-sectional study comprising 17 infectious diseases units in the Lombardy Region, North Italy. All subjects with a first positive test for HIV infection examined in 2008-09 were interviewed using a structured questionnaire. 472 patients were enrolled (mean age 39.8 years, standard deviation [SD] 11.5), mostly males (78%), and born in Italy (77%). The most common routes of HIV transmission were heterosexual intercourse (49%) and sex among men who have sex with men (MSM) (40%). Never/sometimes use of a condom with occasional partners was associated with male gender, heterosexual transmission route, and with >10 sexual partners in their lifetime. 47% had previous HIV negative tests. Having had more than 2 previous HIV negative tests was associated with younger age, MSM transmission route, CD4+ lymphocyte count >350/microl and self-perception of risk. This study shows that there is a large portion of the adult population, especially heterosexual men aged 45 years and over, who are at high risk of acquiring and transmitting HIV infection and undergoing the HIV diagnostic test late, due to risk behaviours combined with a low perception of being at risk. Compared to people infected by heterosexual contacts, MSM show a greater awareness of being at risk of infection, but this knowledge has a low impact in reducing at-risk behaviours.

  3. An overview of recent projects to study thermal protection in life rafts, lifeboats and immersion suits

    Energy Technology Data Exchange (ETDEWEB)

    Mak, L.; DuCharme, M. B.; Farnworth, B.; Wissler, E. H.; Brown, R.; Kuczora, A. [Maritime and Arctic Survival Scientific and Engineering Ressearch Team (Canada)

    2011-07-01

    Survival during a marine evacuation in cold regions is very challenging. However international regulations do not require specific thermal protection or ventilation performance criteria for lifeboats. In the same way, the testing methods for approval testing of immersion suits are not standardised. This paper investigated recent projects completed or on-going to study thermal protection in life rafts, lifeboats and immersion suits. An overview of several projects from the Maritime and Arctic Survival Scientific and Engineering Research Team (MASSERT) was conducted. This review provided the necessary knowledge to advance international standards and develop the thermal protection requirements for survival in the Arctic. The results showed the MASSERT correlated thermal insulation values between human subjects and thermal manikins in life rafts and in immersion suits. It was found that the manikins are a valuable evaluation tool, as well as the computerised models used as prediction tools.

  4. Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Wetterslev, Jørn; Gluud, Christian

    2006-01-01

    Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University...

  5. Role of the internet as an information resource before anaesthesia consultation: A French prospective multicentre survey.

    Science.gov (United States)

    Nucci, Bastian; Claret, Pierre-Geraud; Leclerc, Gilles; Chaumeron, Arnaud; Grillo, Philippe; Buleon, Clément; Leprince, Vincent; Raux, Mathieu; Minville, Vincent; Futier, Emmanuel; Lefrant, Jean-Yves; Cuvillon, Philippe

    2017-12-01

    Use of the internet as an information search tool has increased dramatically. Our study assessed preoperative use of the internet by patients to search for information regarding anaesthesia, surgery, pain or outcomes. The aim of this study was to test whether patients used the internet prior to surgery and what kinds of information they looked for (anaesthetic technique, pain, adverse events, outcomes and surgery). Correlation between patient age and information sought about surgery from the internet was also explored. A prospective multicentre observational study. In total, 14 French private and public institutions from May 2015 to January 2016. In total, 3161 adult patients scheduled for elective surgery under regional or general anaesthesia. An anonymous questionnaire was presented to adult patients scheduled for elective surgery under regional or general anaesthesia for completion before the first meeting with the anaesthesiologist. The investigator at each centre completed specific items that the patient could not complete. We defined the primary endpoint as the number of patients who searched for information about their anaesthesia or surgery on the internet by the time of the their preanaesthetic consultation. Of the 3234 questionnaires distributed, responses were received from 3161 patients. Within this respondent sample, 1304 (45%) were professionally active and 1664 (59%) used the internet at least once per day. Among 3098 (98%) patients who answered the question concerning the primary endpoint, 1506 (48%) had searched the internet for information about their health. In total, 784 (25%) used the internet to find information about their surgery and 113 (3.5%) looked for specific information about anaesthesia. Of the 3161, 52% reported difficulty searching for appropriate information about anaesthesia on the internet. 'Daily use of the web' [odds ratio (OR) 2.0; (95% CI: 1.65 to 2.55) P internet was not widely used by patients scheduled for elective

  6. Protocol for a multicentre, prospective, population-based cohort study of variation in practice of cholecystectomy and surgical outcomes (The CholeS study).

    Science.gov (United States)

    Vohra, Ravinder S; Spreadborough, Philip; Johnstone, Marianne; Marriott, Paul; Bhangu, Aneel; Alderson, Derek; Morton, Dion G; Griffiths, Ewen A

    2015-01-12

    Cholecystectomy is one of the most common general surgical operations performed. Despite level one evidence supporting the role of cholecystectomy in the management of specific gallbladder diseases, practice varies between surgeons and hospitals. It is unknown whether these variations account for the differences in surgical outcomes seen in population-level retrospective data sets. This study aims to investigate surgical outcomes following acute, elective and delayed cholecystectomies in a multicentre, contemporary, prospective, population-based cohort. UK and Irish hospitals performing cholecystectomies will be recruited utilising trainee-led research collaboratives. Two months of consecutive, adult patient data will be included. The primary outcome measure of all-cause 30-day readmission rate will be used in this study. Thirty-day complication rates, bile leak rate, common bile duct injury, conversion to open surgery, duration of surgery and length of stay will be measured as secondary outcomes. Prospective data on over 8000 procedures is anticipated. Individual hospitals will be surveyed to determine local policies and service provision. Variations in outcomes will be investigated using regression modelling to adjust for confounders. Research ethics approval is not required for this study and has been confirmed by the online National Research Ethics Service (NRES) decision tool. This novel study will investigate how hospital-level surgical provision can affect patient outcomes, using a cross-sectional methodology. The results are essential to inform commissioning groups and implement changes within the National Health Service (NHS). Dissemination of the study protocol is primarily through the trainee-led research collaboratives and the Association of Upper Gastrointestinal Surgeons (AUGIS). Individual centres will have access to their own results and the collective results of the study will be published in peer-reviewed journals and presented at relevant

  7. The Intelence aNd pRezista Once A Day Study (INROADS): a multicentre, single-arm, open-label study of etravirine and darunavir/ritonavir as dual therapy in HIV-1-infected early treatment-experienced subjects.

    Science.gov (United States)

    Ruane, P J; Brinson, C; Ramgopal, M; Ryan, R; Coate, B; Cho, M; Kakuda, T N; Anderson, D

    2015-05-01

    Following antiretroviral therapy failure, patients are often treated with a three-drug regimen that includes two nucleoside/tide reverse transcriptase inhibitors [N(t)RTIs]. An alternative two-drug nucleoside-sparing regimen may decrease the pill burden and drug toxicities associated with the use of N(t)RTIs. The Intelence aNd pRezista Once A Day Study (INROADS; NCT01199939) evaluated the nucleoside-sparing regimen of etravirine 400 mg with darunavir/ritonavir 800/100 mg once-daily in HIV-1-infected treatment-experienced subjects or treatment-naïve subjects with transmitted resistance. In this exploratory phase 2b, single-arm, open-label, multicentre, 48-week study, the primary endpoint was the proportion of subjects who achieved HIV-1 RNA treatment-experienced subjects or treatment-naïve subjects with transmitted resistance was virologically efficacious and well tolerated. © 2014 British HIV Association.

  8. Results from Carbon Dioxide Washout Testing Using a Suited Manikin Test Apparatus with a Space Suit Ventilation Test Loop

    Science.gov (United States)

    Chullen, Cinda; Conger, Bruce; McMillin, Summer; Vonau, Walt; Kanne, Bryan; Korona, Adam; Swickrath, Mike

    2016-01-01

    NASA is developing an advanced portable life support system (PLSS) to meet the needs of a new NASA advanced space suit. The PLSS is one of the most critical aspects of the space suit providing the necessary oxygen, ventilation, and thermal protection for an astronaut performing a spacewalk. The ventilation subsystem in the PLSS must provide sufficient carbon dioxide (CO2) removal and ensure that the CO2 is washed away from the oronasal region of the astronaut. CO2 washout is a term used to describe the mechanism by which CO2 levels are controlled within the helmet to limit the concentration of CO2 inhaled by the astronaut. Accumulation of CO2 in the helmet or throughout the ventilation loop could cause the suited astronaut to experience hypercapnia (excessive carbon dioxide in the blood). A suited manikin test apparatus (SMTA) integrated with a space suit ventilation test loop was designed, developed, and assembled at NASA in order to experimentally validate adequate CO2 removal throughout the PLSS ventilation subsystem and to quantify CO2 washout performance under various conditions. The test results from this integrated system will be used to validate analytical models and augment human testing. This paper presents the system integration of the PLSS ventilation test loop with the SMTA including the newly developed regenerative Rapid Cycle Amine component used for CO2 removal and tidal breathing capability to emulate the human. The testing and analytical results of the integrated system are presented along with future work.

  9. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

    Directory of Open Access Journals (Sweden)

    Daly Fergus

    2007-03-01

    Full Text Available Abstract Background It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. Conclusion While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully

  10. Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study

    International Nuclear Information System (INIS)

    Rutten, Marianne J; Pijnenborg, Johanna MA; Schreuder, Henk WR; Schutter, Eltjo MJ; Spijkerboer, Anje M; Wensveen, Celesta WM; Zusterzeel, Petra; Mol, Ben Willem J; Kenter, Gemma G; Buist, Marrije R; Gaarenstroom, Katja N; Van Gorp, Toon; Meurs, Hannah S van; Arts, Henriette JG; Bossuyt, Patrick M; Ter Brugge, Henk G; Hermans, Ralph HM; Opmeer, Brent C

    2012-01-01

    Standard treatment of advanced ovarian cancer is surgery and chemotherapy. The goal of surgery is to remove all macroscopic tumour, as the amount of residual tumour is the most important prognostic factor for survival. When removal off all tumour is considered not feasible, neoadjuvant chemotherapy (NACT) in combination with interval debulking surgery (IDS) is performed. Current methods of staging are not always accurate in predicting surgical outcome, since approximately 40% of patients will have more than 1 cm residual tumour after primary debulking surgery (PDS). In this study we aim to assess whether adding laparoscopy to the diagnostic work-up of patients suspected of advanced ovarian carcinoma may prevent unsuccessful primary debulking surgery for ovarian cancer. Multicentre randomized controlled trial, including all gynaecologic oncologic centres in the Netherlands and their affiliated hospitals. Patients are eligible when they are planned for PDS after conventional staging. Participants are randomized between direct PDS or additional diagnostic laparoscopy. Depending on the result of laparoscopy patients are treated by PDS within three weeks, followed by six courses of platinum based chemotherapy or with NACT and IDS 3-4 weeks after three courses of chemotherapy, followed by another three courses of chemotherapy. Primary outcome measure is the proportion of PDS's leaving more than one centimetre tumour residual in each arm. In total 200 patients will be randomized. Data will be analysed according to intention to treat. Patients who have disease considered to be resectable to less than one centimetre should undergo PDS to improve prognosis. However, there is a need for better diagnostic procedures because the current number of debulking surgeries leaving more than one centimetre residual tumour is still high. Laparoscopy before starting treatment for ovarian cancer can be an additional diagnostic tool to predict the outcome of PDS. Despite the absence

  11. Modelling flow and heat transfer around a seated human body by computational fluid dynamics

    DEFF Research Database (Denmark)

    Sørensen, Dan Nørtoft; Voigt, Lars Peter Kølgaard

    2003-01-01

    A database (http://www.ie.dtu.dk/manikin) containing a detailed representation of the surface geometry of a seated female human body was created from a surface scan of a thermal manikin (minus clothing and hair). The radiative heat transfer coefficient and the natural convection flow around...... of the computational manikin has all surface features of a human being; (2) the geometry is an exact copy of an experimental thermal manikin, enabling detailed comparisons between calculations and experiments....

  12. Diagnosis of prosthetic joint infection with alpha-defensin using a lateral flow device: a multicentre study.

    Science.gov (United States)

    Berger, P; Van Cauter, M; Driesen, R; Neyt, J; Cornu, O; Bellemans, J

    2017-09-01

    The purpose of this current multicentre study is to analyse the presence of alpha-defensin proteins in synovial fluid using the Synovasure lateral flow device and to determine its diagnostic reliability and accuracy compared with the prosthetic joint infection (PJI) criteria produced by the Musculoskeletal Infection Society (MSIS). A cohort of 121 patients comprising 85 total knee arthroplasties and 36 total hip arthroplasties was prospectively evaluated between May 2015 and June 2016 in three different orthopaedic centres. The tests were performed on patients with a chronically painful prosthesis undergoing a joint aspiration in a diagnostic pathway or during revision surgery. Based on the MSIS criteria, 34 patients (28%) would have had a PJI, and 87 patients had no PJI. Testing with the lateral flow device had a sensitivity of 97.1% (95% confidence intervals (CI) 84.5 to 99.9) and a specificity of 96.6% (95% CI 90.3 to 99.2). The positive predictive value was 91.7% (95% CI 77.7% to 98.3), and the negative predictive value was 98.8% (95% CI 93.6 to 99.9). Receiver operator characteristics analysis demonstrated an area under the curve for the Synovasure test of 0.97 (95% CI 0.93 to 1.00). Our findings suggest that the Synovasure test has an excellent diagnostic performance to confirm or reject the diagnosis of a PJI. The results are promising for the care of the painful or problematic knee and hip joint arthroplasty and the test should be considered as part of the diagnostic toolbox for PJIs. Cite this article: Bone Joint J 2017;99-B:1176-82. ©2017 The British Editorial Society of Bone & Joint Surgery.

  13. A large multi-centre European study validates high-sensitivity C-reactive protein (hsCRP) as a clinical biomarker for the diagnosis of diabetes subtypes

    DEFF Research Database (Denmark)

    Thanabalasingham, G.; Shah, N.; Vaxillaire, M.

    2011-01-01

    CRP) levels are lower in UK patients with hepatocyte nuclear factor 1 alpha (HNF1A)-MODY than in other diabetes subtypes. In this large multi-centre study we aimed to assess the clinical validity of hsCRP as a diagnostic biomarker, examine the genotype-phenotype relationship and compare different hsCRP assays....... High-sensitivity CRP levels were analysed in individuals with HNF1A-MODY (n = 457), glucokinase (GCK)-MODY (n = 404), hepatocyte nuclear factor 4 alpha (HNF4A)-MODY (n = 54) and type 2 diabetes (n = 582) from seven European centres. Three common assays for hsCRP analysis were evaluated. We excluded 121......) a parts per thousand yenaEuro parts per thousand 0.91, p a parts per thousand currency signaEuro parts per thousand 1 x 10(-5)). Across the seven centres, the C-statistic for distinguishing HNF1A-MODY from young adult-onset type 2 diabetes ranged from 0.79 to 0.97, indicating high discriminative accuracy...

  14. Measurement of HbA1c in multicentre diabetes trials - should blood samples be tested locally or sent to a central laboratory: an agreement analysis.

    Science.gov (United States)

    Arch, Barbara N; Blair, Joanne; McKay, Andrew; Gregory, John W; Newland, Paul; Gamble, Carrol

    2016-10-24

    Glycated haemoglobin (HbA1c) is an important outcome measure in diabetes clinical trials. For multicentre designs, HbA1c can be measured locally at participating centres or by sending blood samples to a central laboratory. This study analyses the agreement between local and central measurements, using 1-year follow-up data collected in a multicentre randomised controlled trial (RCT) of newly diagnosed children with type I diabetes. HbA1c measurements were routinely analysed both locally and centrally at baseline and then at 3, 6, 9 and 12 months and the data reported in mmol/mol. Agreement was assessed by calculating the bias and 95 % limits of agreement, using the Bland-Altman analysis method. A predetermined benchmark for clinically acceptable margin of error between measurements was subjectively set as ±10 % for HbA1c. The percentage of pairs of measurements that were classified as clinically acceptable was calculated. Descriptive statistics were used to examine the agreement within centres. Treatment group was not considered. Five hundred and ninety pairs of measurement, representing 255 children and 15 trial centres across four follow-up time points, were compared. There was no significant bias: local measurements were an average of 0.16 mmol/mol (SD = 4.5, 95 % CI -0.2 to 0.5) higher than central. The 95 % limits of agreement were -8.6 to 9.0 mmol/mol (local minus central). Eighty percent of local measurements were within ±10 % of corresponding central measurements. Some trial centres were more varied in the differences observed between local and central measurements: IQRs ranging from 3 to 9 mmol/mol; none indicated systematic bias. Variation in agreement between HbA1c measurements was greater than had been expected although no overall bias was detected and standard deviations were similar. Discrepancies were present across all participating centres. These findings have implications for the comparison of standards of clinical care between centres

  15. Can Clinical and Surgical Parameters Be Combined to Predict How Long It Will Take a Tibia Fracture to Heal? A Prospective Multicentre Observational Study: The FRACTING Study

    Directory of Open Access Journals (Sweden)

    Leo Massari

    2018-01-01

    Full Text Available Background. Healing of tibia fractures occurs over a wide time range of months, with a number of risk factors contributing to prolonged healing. In this prospective, multicentre, observational study, we investigated the capability of FRACTING (tibia FRACTure prediction healING days score, calculated soon after tibia fracture treatment, to predict healing time. Methods. The study included 363 patients. Information on patient health, fracture morphology, and surgical treatment adopted were combined to calculate the FRACTING score. Fractures were considered healed when the patient was able to fully weight-bear without pain. Results. 319 fractures (88% healed within 12 months from treatment. Forty-four fractures healed after 12 months or underwent a second surgery. FRACTING score positively correlated with days to healing: r=0.63 (p<0.0001. Average score value was 7.3 ± 2.5; ROC analysis showed strong reliability of the score in separating patients healing before versus after 6 months: AUC = 0.823. Conclusions. This study shows that the FRACTING score can be employed both to predict months needed for fracture healing and to identify immediately after treatment patients at risk of prolonged healing. In patients with high score values, new pharmacological and nonpharmacological treatments to enhance osteogenesis could be tested selectively, which may finally result in reduced disability time and health cost savings.

  16. A multicomponent approach to identify predictors of hospital outcomes in older in-patients: a multicentre, observational study.

    Directory of Open Access Journals (Sweden)

    Stefanie L De Buyser

    Full Text Available BACKGROUND: The identification of older patients at risk of poor hospital outcomes (e.g. longer hospital stay, in-hospital mortality, and institutionalisation is important to provide an effective healthcare service. OBJECTIVE: To identify factors related to older patients' clinical, nutritional, functional and socio-demographic profiles at admission to an acute care ward that can predict poor hospital outcomes. DESIGN AND SETTING: The CRiteria to assess appropriate Medication use among Elderly complex patients project was a multicentre, observational study performed in geriatric and internal medicine acute care wards of seven Italian hospitals. SUBJECTS: One thousand one hundred twenty-three consecutively admitted patients aged 65 years or older. METHODS: Hospital outcomes were length of stay, in-hospital mortality, and institutionalisation. RESULTS: Mean age of participants was 81 years, 56% were women. Median length of stay was 10 (7-14 days, 41 patients died during hospital stay and 37 were newly institutionalised. Number of drugs before admission, metastasized cancer, renal failure or dialysis, infection, falls at home during the last year, pain, and walking speed were independent predictors of LoS. Total dependency in activities of daily living and inability to perform grip strength test were independent predictors of in-hospital mortality. Malnutrition and total dependency in activities of daily living were independent predictors of institutionalisation. CONCLUSIONS: Our results confirm that not only diseases, but also multifaceted aspects of ageing such as physical function and malnutrition are strong predictors of hospital outcomes and suggest that these variables should be systematically recorded.

  17. Open Abdomen Therapy with Vacuum and Mesh Mediated Fascial Traction After Aortic Repair: an International Multicentre Study.

    Science.gov (United States)

    Acosta, Stefan; Seternes, Arne; Venermo, Maarit; Vikatmaa, Leena; Sörelius, Karl; Wanhainen, Anders; Svensson, Mats; Djavani, Khatereh; Björck, Martin

    2017-12-01

    Open abdomen therapy may be necessary to prevent or treat abdominal compartment syndrome (ACS). The aim of the study was to analyse the primary delayed fascial closure (PDFC) rate and complications after open abdomen therapy with vacuum and mesh mediated fascial traction (VACM) after aortic repair and to compare outcomes between those treated with open abdomen after primary versus secondary operation. This was a retrospective cohort, multicentre study in Sweden, Finland, and Norway, including consecutive patients treated with open abdomen and VACM after aortic repair at six vascular centres in 2006-2015. The primary endpoint was PDFC rate. Among 191 patients, 155 were men. The median age was 71 years (IQR 66-76). Ruptured abdominal aortic aneurysm (RAAA) occurred in 69.1%. Endovascular/hybrid and open repairs were performed in 49 and 142 patients, respectively. The indications for open abdomen were inability to close the abdomen (62%) at primary operation and ACS (80%) at secondary operation. Duration of open abdomen was 11 days (IQR 7-16) in 157 patients alive at open abdomen termination. The PDFC rate was 91.8%. Open abdomen initiated at primary (N=103), compared with secondary operation (N=88), was associated with less severe initial open abdomen status (p=.006), less intestinal ischaemia (p=.002), shorter duration of open abdomen (p=.007), and less renal replacement therapy (RRT, popen abdomen initiated at primary versus secondary operation. VACM was associated with a high PDFC rate after prolonged open abdomen therapy following aortic repair. Patient outcomes seemed better when open abdomen was initiated at primary, compared with secondary operation but a selection effect is possible. Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

  18. Discontinuation of tofacitinib after achieving low disease activity in patients with rheumatoid arthritis: a multicentre, observational study.

    Science.gov (United States)

    Kubo, Satoshi; Yamaoka, Kunihiro; Amano, Koichi; Nagano, Shuji; Tohma, Shigeto; Suematsu, Eiichi; Nagasawa, Hayato; Iwata, Kanako; Tanaka, Yoshiya

    2017-08-01

    To determine whether tofacitinib can be discontinued in patients with RA who achieve low disease activity (LDA). RA patients with LDA after tofacitinib treatment in a phase III and long-term extension study were enrolled in this multicentre, non-randomized, open, prospective, observational study. The decision of discontinuation or continuation of tofacitinib was determined based on patient-physician decision making with informed consent. The primary endpoint was the proportion of patients who remained tofacitinib-free at post-treatment week 52. Clinical outcome was compared between those who continued and those who discontinued tofacitinib. The last observation carried forward method was used for patients who could not discontinue tofacitinib before week 52. Of 64 patients, 54 discontinued and 10 continued tofacitinib therapy. At post-treatment week 52, 20 of the 54 patients (37%) of the discontinuation group remained tofacitinib-free without disease flare. Disease activity at post-treatment week 52 was higher in the discontinuation group than the continuation group. Among the discontinuation group, the RF titre at baseline was significantly lower in patients who remained tofacitinib-free than those who did not (40 vs 113 U/ml). In fact, a higher proportion of patients with lower RF remained tofacitinib-free at week 52 compared with those with higher RF at baseline. In patients who could not achieve tofacitinib-free status, re-initiation of tofacitinib or other biologics improved disease activity. It is possible to discontinue tofacitinib without flare in about a third of patients with RA. A low RF predicts maintenance of LDA after discontinuation of tofacitinib. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  19. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications.

    Science.gov (United States)

    Schmidt, Arthur; Beyna, Torsten; Schumacher, Brigitte; Meining, Alexander; Richter-Schrag, Hans-Juergen; Messmann, Helmut; Neuhaus, Horst; Albers, David; Birk, Michael; Thimme, Robert; Probst, Andreas; Faehndrich, Martin; Frieling, Thomas; Goetz, Martin; Riecken, Bettina; Caca, Karel

    2017-08-10

    Endoscopic full-thickness resection (EFTR) is a novel treatment of colorectal lesions not amenable to conventional endoscopic resection. The aim of this prospective multicentre study was to assess the efficacy and safety of the full-thickness resection device. 181 patients were recruited in 9 centres with the indication of difficult adenomas (non-lifting and/or at difficult locations), early cancers and subepithelial tumours (SET). Primary endpoint was complete en bloc and R0 resection. EFTR was technically successful in 89.5%, R0 resection rate was 76.9%. In 127 patients with difficult adenomas and benign histology, R0 resection rate was 77.7%. In 14 cases, lesions harboured unsuspected cancer, another 15 lesions were primarily known as cancers. Of these 29 cases, R0 resection was achieved in 72.4%; 8 further cases had deep submucosal infiltration >1000 µm. Therefore, curative resection could only be achieved in 13/29 (44.8%). In the subgroup with SET (n=23), R0 resection rate was 87.0%. In general, R0 resection rate was higher with lesions ≤2 cm vs >2 cm (81.2% vs 58.1%, p=0.0038). Adverse event rate was 9.9% with a 2.2% rate of emergency surgery. Three-month follow-up was available from 154 cases and recurrent/residual tumour was evident in 15.3%. EFTR has a reasonable technical efficacy especially in lesions ≤2 cm with acceptable complication rates. Curative resection rate for early cancers was too low to recommend its primary use in this indication. Further comparative studies have to show the clinical value and long-term outcome of EFTR in benign colorectal lesions. NCT02362126; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Influence of quality of care and individual patient characteristics on quality of life and return to work in survivors of the acute respiratory distress syndrome: protocol for a prospective, observational, multi-centre patient cohort study (DACAPO).

    Science.gov (United States)

    Brandstetter, Susanne; Dodoo-Schittko, Frank; Blecha, Sebastian; Sebök, Philipp; Thomann-Hackner, Kathrin; Quintel, Michael; Weber-Carstens, Steffen; Bein, Thomas; Apfelbacher, Christian

    2015-12-17

    Health-related quality of life (HRQoL) and return to work are important outcomes in critical care medicine, reaching beyond mortality. Little is known on factors predictive of HRQoL and return to work in critical illness, including the acute respiratory distress syndrome (ARDS), and no evidence exists on the role of quality of care (QoC) for outcomes in survivors of ARDS. It is the aim of the DACAPO study ("Surviving ARDS: the influence of QoC and individual patient characteristics on quality of life") to investigate the role of QoC and individual patient characteristics on quality of life and return to work. A prospective, observational, multi-centre patient cohort study will be performed in Germany, using hospitals from the "ARDS Network Germany" as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyse a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. QoC will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (HRQoL and return to work) will be assessed by self-report questionnaires. Further data collection includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of QoC and individual patient characteristics on outcomes, taking the cluster structure of the data into account. By obtaining comprehensive data at patient and hospital level using a prospective multi-centre design, the DACAPO-study is the first study investigating the influence of QoC on individual outcomes of ARDS survivors.

  1. Changing prevalence patterns in endoscopic and histological diagnosis of gastritis? Data from a cross-sectional Central European multicentre study.

    Science.gov (United States)

    Wolf, Eva-Maria; Plieschnegger, Wolfgang; Geppert, Michael; Wigginghaus, Bernd; Höss, Gabriele M; Eherer, Andreas; Schneider, Nora I; Hauer, Almuthe; Rehak, Peter; Vieth, Michael; Langner, Cord

    2014-05-01

    Traditionally, Helicobacter infection is considered to be the most common cause of gastritis. In the cross-sectional Central European histoGERD trial, we assessed the prevalence of different types of gastritis, correlating histological and endoscopic diagnoses. A total of 1123 individuals participated in an observational multicentre study. Endoscopists classified individuals as positive or negative for gastritis and rendered the putative cause. Pathologists evaluated biopsy specimens based upon the Updated Sydney System. Histological diagnosis of gastritis was made in 639 (56.9%) participants. In all, 210 (18.7%) individuals were diagnosed with Helicobacter gastritis, 215 (19.1%) with post Helicobacter gastritis, 234 (20.8%) with reactive gastropathy, 26 (2.3%) with autoimmune gastritis, and 6 (0.5%) with focally enhanced gastritis related to Crohn's disease. In 46 out of 639 (7.2%) individuals diagnosed with gastritis, combinations of different histological subtypes were noted the most common being reactive gastropathy and post Helicobacter gastritis. Endoscopic diagnosis of gastritis was made in 534 (47.6%) individuals. Reactive gastropathy was more common than active Helicobacter gastritis, and the majority of cases attributable to Helicobacter infection were no longer ongoing, i.e. post Helicobacter gastritis. Agreement between histological and endoscopic diagnoses was better in reactive gastropathy than in Helicobacter gastritis. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  2. The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC): experiences from a successful ERS Clinical Research Collaboration.

    Science.gov (United States)

    Chalmers, James D; Crichton, Megan; Goeminne, Pieter C; Loebinger, Michael R; Haworth, Charles; Almagro, Marta; Vendrell, Montse; De Soyza, Anthony; Dhar, Raja; Morgan, Lucy; Blasi, Francesco; Aliberti, Stefano; Boyd, Jeanette; Polverino, Eva

    2017-09-01

    In contrast to airway diseases like chronic obstructive pulmonary disease or asthma, and rare diseases such as cystic fibrosis, there has been little research and few clinical trials in bronchiectasis. Guidelines are primarily based on expert opinion and treatment is challenging because of the heterogeneous nature of the disease. In an effort to address decades of underinvestment in bronchiectasis research, education and clinical care, the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative pan-European network to bring together bronchiectasis researchers. The European Respiratory Society officially funded EMBARC in 2013 as a Clinical Research Collaboration, providing support and infrastructure to allow the project to grow. EMBARC has now established an international bronchiectasis registry that is active in more than 30 countries both within and outside Europe. Beyond the registry, the network participates in designing and facilitating clinical trials, has set international research priorities, promotes education and has participated in producing the first international bronchiectasis guidelines. This manuscript article the development, structure and achievements of EMBARC from 2012 to 2017. To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areasTo understand some of the key features of successful disease registriesTo review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project in the past 5 yearsTo understand the key research priorities identified by EMBARC for the next 5 years.

  3. Complete en bloc urinary exenteration for synchronous multicentric transitional cell carcinoma with sarcomatoid features in a hemodialysis patient

    Directory of Open Access Journals (Sweden)

    Tiberio M. Siqueira Jr

    2006-10-01

    Full Text Available The incidence of transitional cell carcinoma (TCC in patients submitted to hemodialysis is low. The presence of TCC with sarcomatoid features in this cohort is even scarcer. Herein, we describe a very rare case of synchronous multicentric muscle invasive bladder carcinoma with prostate invasion in a hemodialysis patient, submitted to complete en bloc urinary exenteration.

  4. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China.

    Science.gov (United States)

    Zhao, Ling; Zhang, Fu-wen; Li, Ying; Wu, Xi; Zheng, Hui; Cheng, Lin-hao; Liang, Fan-rong

    2011-03-24

    In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs) to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence. This observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis. Among the 1968 patients, 74 patients (3.76%) suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients. Acupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs) were related to the patients' gender and age and the local anatomical structure of the acupoints. AEs could be reduced and

  5. A multi-centre cohort study shows no association between experienced violence and labour dystocia in nulliparous women at term

    Science.gov (United States)

    2011-01-01

    Background Although both labour dystocia and domestic violence during pregnancy are associated with adverse maternal and fetal outcome, evidence in support of a possible association between experiences of domestic violence and labour dystocia is sparse. The aim of this study was to investigate whether self-reported history of violence or experienced violence during pregnancy is associated with increased risk of labour dystocia in nulliparous women at term. Methods A population-based multi-centre cohort study. A self-administrated questionnaire collected at 37 weeks of gestation from nine obstetric departments in Denmark. The total cohort comprised 2652 nulliparous women, among whom 985 (37.1%) met the protocol criteria for dystocia. Results Among the total cohort, 940 (35.4%) women reported experience of violence, and among these, 66 (2.5%) women reported exposure to violence during their first pregnancy. Further, 39.5% (n = 26) of those had never been exposed to violence before. Univariate logistic regression analysis showed no association between history of violence or experienced violence during pregnancy and labour dystocia at term, crude OR 0.91, 95% CI (0.77-1.08), OR 0.90, 95% CI (0.54-1.50), respectively. However, violence exposed women consuming alcoholic beverages during late pregnancy had increased odds of labour dystocia, crude OR 1.45, 95% CI (1.07-1.96). Conclusions Our findings indicate that nulliparous women who have a history of violence or experienced violence during pregnancy do not appear to have a higher risk of labour dystocia at term, according to the definition of labour dystocia in this study. Additional research on this topic would be beneficial, including further evaluation of the criteria for labour dystocia. PMID:21338523

  6. A multi-centre cohort study shows no association between experienced violence and labour dystocia in nulliparous women at term.

    Science.gov (United States)

    Finnbogadóttir, Hafrún; Dejin-Karlsson, Elisabeth; Dykes, Anna-Karin

    2011-02-21

    Although both labour dystocia and domestic violence during pregnancy are associated with adverse maternal and fetal outcome, evidence in support of a possible association between experiences of domestic violence and labour dystocia is sparse. The aim of this study was to investigate whether self-reported history of violence or experienced violence during pregnancy is associated with increased risk of labour dystocia in nulliparous women at term. A population-based multi-centre cohort study. A self-administrated questionnaire collected at 37 weeks of gestation from nine obstetric departments in Denmark. The total cohort comprised 2652 nulliparous women, among whom 985 (37.1%) met the protocol criteria for dystocia. Among the total cohort, 940 (35.4%) women reported experience of violence, and among these, 66 (2.5%) women reported exposure to violence during their first pregnancy. Further, 39.5% (n = 26) of those had never been exposed to violence before. Univariate logistic regression analysis showed no association between history of violence or experienced violence during pregnancy and labour dystocia at term, crude OR 0.91, 95% CI (0.77-1.08), OR 0.90, 95% CI (0.54-1.50), respectively. However, violence exposed women consuming alcoholic beverages during late pregnancy had increased odds of labour dystocia, crude OR 1.45, 95% CI (1.07-1.96). Our findings indicate that nulliparous women who have a history of violence or experienced violence during pregnancy do not appear to have a higher risk of labour dystocia at term, according to the definition of labour dystocia in this study. Additional research on this topic would be beneficial, including further evaluation of the criteria for labour dystocia.

  7. Benefit of particle therapy in re-irradiation of head and neck patients. Results of a multicentric in silico ROCOCO trial

    NARCIS (Netherlands)

    Eekers, D.B.; Roelofs, E.; Jelen, U.; Kirk, M.; Granzier, M.; Ammazzalorso, F.; Ahn, P.H.; Janssens, G.O.; Hoebers, F.J.; Friedmann, T.; Solberg, T.; Walsh, S.; Troost, E.G.; Kaanders, J.H.A.M.; Lambin, P.

    2016-01-01

    BACKGROUND AND PURPOSE: In this multicentric in silico trial we compared photon, proton, and carbon-ion radiotherapy plans for re-irradiation of patients with squamous cell carcinoma of the head and neck (HNSCC) regarding dose to tumour and doses to surrounding organs at risk (OARs). MATERIAL AND

  8. Chronic pancreatitis: Multicentre prospective data collection and analysis by the Hungarian Pancreatic Study Group.

    Directory of Open Access Journals (Sweden)

    Ákos Szücs

    Full Text Available Chronic pancreatitis is an inflammatory disease associated with structural and functional damage to the pancreas, causing pain, maldigestion and weight loss and thus worsening the quality of life.Our aim was to find correlations from a multicentre database representing the epidemiological traits, diagnosis and treatment of the disease in Hungary. The Hungarian Pancreatic Study Group collected data prospectively from 2012 to 2014 on patients suffering from chronic pancreatitis. Statistical analysis was performed on different questions.Data on 229 patients (74% male and 26% female were uploaded from 14 centres. Daily alcohol consumption was present in the aetiology of 56% of the patients. 66% of the patients were previously treated for acute exacerbation. One third of the patients had had previous endoscopic or surgical interventions. Pain was present in 69% of the cases, endocrine insufficiency in 33%, diarrhoea in 13% and weight loss in 39%. Diagnosis was confirmed with US (80%, CT scan (52%, MRI-MRCP (6%, ERCP (39%, and EUS (7,4%. A functional test was carried out in 5% of the patients. In 31% of the cases, an endoscopic intervention was performed with the need for re-intervention in 5%. Further elective surgical intervention was necessitated in 44% of endoscopies. 20% of the registered patients were primarily treated with surgery. The biliary complication rate for surgery was significantly smaller (2% than endoscopy (27%; however, pancreatic complications were higher in the patients treated with surgery. Patients who smoked regularly needed significantly more surgical intervention following endoscopy (66.7% vs. 26.9%, p = 0.002 than non-smokers, and the ratio of surgical intervention alone was also significantly higher (27.3% vs. 10.8%, p = 0.004. The ratio of surgery in patients who smoked and drank was significantly higher (30.09% vs. 12.5%, p = 0.012 than in abstinent and non-smoking patients, similarly to the need for further surgical

  9. Chronic pancreatitis: Multicentre prospective data collection and analysis by the Hungarian Pancreatic Study Group.

    Science.gov (United States)

    Szücs, Ákos; Marjai, Tamás; Szentesi, Andrea; Farkas, Nelli; Párniczky, Andrea; Nagy, György; Kui, Balázs; Takács, Tamás; Czakó, László; Szepes, Zoltán; Németh, Balázs Csaba; Vincze, Áron; Pár, Gabriella; Szabó, Imre; Sarlós, Patrícia; Illés, Anita; Gódi, Szilárd; Izbéki, Ferenc; Gervain, Judit; Halász, Adrienn; Farkas, Gyula; Leindler, László; Kelemen, Dezső; Papp, Róbert; Szmola, Richárd; Varga, Márta; Hamvas, József; Novák, János; Bod, Barnabás; Sahin-Tóth, Miklós; Hegyi, Péter

    2017-01-01

    Chronic pancreatitis is an inflammatory disease associated with structural and functional damage to the pancreas, causing pain, maldigestion and weight loss and thus worsening the quality of life. Our aim was to find correlations from a multicentre database representing the epidemiological traits, diagnosis and treatment of the disease in Hungary. The Hungarian Pancreatic Study Group collected data prospectively from 2012 to 2014 on patients suffering from chronic pancreatitis. Statistical analysis was performed on different questions. Data on 229 patients (74% male and 26% female) were uploaded from 14 centres. Daily alcohol consumption was present in the aetiology of 56% of the patients. 66% of the patients were previously treated for acute exacerbation. One third of the patients had had previous endoscopic or surgical interventions. Pain was present in 69% of the cases, endocrine insufficiency in 33%, diarrhoea in 13% and weight loss in 39%. Diagnosis was confirmed with US (80%), CT scan (52%), MRI-MRCP (6%), ERCP (39%), and EUS (7,4%). A functional test was carried out in 5% of the patients. In 31% of the cases, an endoscopic intervention was performed with the need for re-intervention in 5%. Further elective surgical intervention was necessitated in 44% of endoscopies. 20% of the registered patients were primarily treated with surgery. The biliary complication rate for surgery was significantly smaller (2%) than endoscopy (27%); however, pancreatic complications were higher in the patients treated with surgery. Patients who smoked regularly needed significantly more surgical intervention following endoscopy (66.7% vs. 26.9%, p = 0.002) than non-smokers, and the ratio of surgical intervention alone was also significantly higher (27.3% vs. 10.8%, p = 0.004). The ratio of surgery in patients who smoked and drank was significantly higher (30.09% vs. 12.5%, p = 0.012) than in abstinent and non-smoking patients, similarly to the need for further surgical

  10. Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

    OpenAIRE

    Nauth, A. (Aaron); Creek, A.T. (Aaron T.); Zellar, A. (Abby); Lawendy, A.-R. (Abdel-Rahman); Dowrick, A. (Adam); Gupta, A. (Ajay); Dadi, A. (Akhil); Kampen, A.; Yee, A. (Albert); Vries, Alexander; de Mol van Otterloo, A. (Alexander); Garibaldi, A. (Alisha); Liew, A. (Allen); McIntyre, A.W. (Allison W.); Prasad, A.S. (Amal Shankar)

    2017-01-01

    textabstractBackground Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a...

  11. The impact of virus infections on pneumonia mortality is complex in adults: a prospective multicentre observational study.

    Science.gov (United States)

    Katsurada, Naoko; Suzuki, Motoi; Aoshima, Masahiro; Yaegashi, Makito; Ishifuji, Tomoko; Asoh, Norichika; Hamashige, Naohisa; Abe, Masahiko; Ariyoshi, Koya; Morimoto, Konosuke

    2017-12-06

    Various viruses are known to be associated with pneumonia. However, the impact of viral infections on adult pneumonia mortality remains unclear. This study aimed to clarify the effect of virus infection on pneumonia mortality among adults stratified by virus type and patient comorbidities. This multicentre prospective study enrolled pneumonia patients aged ≥15 years from September 2011 to August 2014. Sputum samples were tested by in-house multiplex polymerase chain reaction assays to identify 13 respiratory viruses. Viral infection status and its effect on in-hospital mortality were examined by age group and comorbidity status. A total of 2617 patients were enrolled in the study and 77.8% was aged ≥65 years. 574 (21.9%) did not have comorbidities, 790 (30.2%) had chronic respiratory disease, and 1253 (47.9%) had other comorbidities. Viruses were detected in 605 (23.1%) patients. Human rhinovirus (9.8%) was the most frequently identified virus, followed by influenza A (3.9%) and respiratory syncytial virus (3.9%). Respiratory syncytial virus was more frequently identified in patients with chronic respiratory disease (4.7%) than those with other comorbidities (4.2%) and without comorbidities (2.1%) (p = 0.037). The frequencies of other viruses were almost identical between the three groups. Virus detection overall was not associated with increased mortality (adjusted risk ratio (ARR) 0.76, 95% CI 0.53-1.09). However, influenza virus A and B were associated with three-fold higher mortality in patients with chronic respiratory disease but not with other comorbidities (ARR 3.38, 95% CI 1.54-7.42). Intriguingly, paramyxoviruses were associated with dramatically lower mortality in patients with other comorbidities (ARR 0.10, 95% CI 0.01-0.70) but not with chronic respiratory disease. These effects were not affected by age group. The impact of virus infections on pneumonia mortality varies by virus type and comorbidity status in adults.

  12. TAFRO syndrome: New subtype of idiopathic multicentric Castleman disease

    Directory of Open Access Journals (Sweden)

    Gordan Srkalovic

    2017-05-01

    Full Text Available Castleman disease (CD describes a group of three rare and poorly understood lymphoproliferative disorders that have heterogeneous clinical symptoms and common lymph node histopathological features. Unicentric CD (UCD involves a single region of enlarged nodes. Multicentric CD (MCD involves multiple regions of enlarged lymph nodes, constitutional symptoms, and organ dysfunction due to a cytokine storm often including interleukin 6. MCD is further divided into Human Herpes Virus-8 (HHV-8-associated MCD, which occurs in immunocompromised individuals, and HHV-8-negative/idiopathic MCD (iMCD. Recently, iMCD has been further sub-divided into patients with TAFRO syndrome, which involves thrombocytopenia (T, anasarca (A, fevers (F, reticulin myelofibrosis (R, organomegaly (O, and normal or only slightly elevated immunoglobulin levels, and those who do not have TAFRO syndrome. Non-TAFRO iMCD patients typically have thrombocytosis, less severe fluid accumulation, and hypergammaglobulinemia. iMCD patients with TAFRO syndrome may have a worse prognosis, but more research is needed.

  13. Laparoscopic excision of deep rectovaginal endometriosis in BSGE endometriosis centres: a multicentre prospective cohort study

    Science.gov (United States)

    Byrne, Dominic; Curnow, Tamara; Smith, Paul; Cutner, Alfred; Saridogan, Ertan; Clark, T Justin

    2018-01-01

    Objective To estimate the effectiveness and safety of laparoscopic surgical excision of rectovaginal endometriosis. Design A multicentre, prospective cohort study. Setting 51 hospitals accredited as specialist endometriosis centres. Participants 5162 women of reproductive age with rectovaginal endometriosis of which 4721 women had planned laparoscopic excision. Interventions Laparoscopic surgical excision of rectovaginal endometriosis requiring dissection of the pararectal space. Main outcome measures Standardised symptom questionnaires enquiring about chronic pelvic pain, bladder and bowel symptoms, analgesia use and quality of life (EuroQol) completed prior to surgery and at 6, 12 and 24 months postoperatively. Serious perioperative and postoperative complications including major haemorrhage, infection and visceral injury were recorded. Results At 6 months postsurgery, there were significant reductions in premenstrual, menstrual and non-cyclical pelvic pain, deep dyspareunia, dyschezia, low back pain and bladder pain. In addition, there were significant reductions in voiding difficulty, bowel frequency, urgency, incomplete emptying, constipation and passing blood. These reductions were maintained at 2 years, with the exception of voiding difficulty. Global quality of life significantly improved from a median pretreatment score of 55/100 to 80/100 at 6 months. There was a significant improvement in quality of life in all measured domains and in quality-adjusted life years. These improvements were sustained at 2 years. All analgesia use was reduced and, in particular, opiate use fell from 28.1% prior to surgery to 16.1% at 6 months. The overall incidence of complications was 6.8% (321/4721). Gastrointestinal complications (enterotomy, anastomotic leak or fistula) occurred in 52 (1.1%) operations and of the urinary tract (ureteric/bladder injury or leak) in 49 (1.0%) procedures. Conclusion Laparoscopic surgical excision of rectovaginal endometriosis

  14. Effect of feedback on delaying deterioration in quality of compressions during 2 minutes of continuous chest compressions: a randomized manikin study investigating performance with and without feedback

    Directory of Open Access Journals (Sweden)

    Lyngeraa Tobias

    2012-02-01

    Full Text Available Abstract Background Good quality basic life support (BLS improves outcome following cardiac arrest. As BLS performance deteriorates over time we performed a parallel group, superiority study to investigate the effect of feedback on quality of chest compression with the hypothesis that feedback delays deterioration of quality of compressions. Methods Participants attending a national one-day conference on cardiac arrest and CPR in Denmark were randomized to perform single-rescuer BLS with (n = 26 or without verbal and visual feedback (n = 28 on a manikin using a ZOLL AED plus. Data were analyzed using Rescuenet Code Review. Blinding of participants was not possible, but allocation concealment was performed. Primary outcome was the proportion of delivered compressions within target depth compared over a 2-minute period within the groups and between the groups. Secondary outcome was the proportion of delivered compressions within target rate compared over a 2-minute period within the groups and between the groups. Performance variables for 30-second intervals were analyzed and compared. Results 24 (92% and 23 (82% had CPR experience in the group with and without feedback respectively. 14 (54% were CPR instructors in the feedback group and 18 (64% in the group without feedback. Data from 26 and 28 participants were analyzed respectively. Although median values for proportion of delivered compressions within target depth were higher in the feedback group (0-30 s: 54.0%; 30-60 s: 88.0%; 60-90 s: 72.6%; 90-120 s: 87.0%, no significant difference was found when compared to without feedback (0-30 s: 19.6%; 30-60 s: 33.1%; 60-90 s: 44.5%; 90-120 s: 32.7% and no significant deteriorations over time were found within the groups. In the feedback group a significant improvement was found in the proportion of delivered compressions below target depth when the subsequent intervals were compared to the first 30 seconds (0-30 s: 3.9%; 30-60 s: 0.0%; 60-90 s: 0

  15. Biopsy transcriptome expression profiling to identify kidney transplants at risk of chronic injury: a multicentre, prospective study

    Science.gov (United States)

    O’Connell, Philip J; Zhang, Weijia; Menon, Madhav C; Yi, Zhengzi; Schröppel, Bernd; Gallon, Lorenzo; Luan, Yi; Rosales, Ivy A; Ge, Yongchao; Losic, Bojan; Xi, Caixia; Woytovich, Christopher; Keung, Karen L; Wei, Chengguo; Greene, Ilana; Overbey, Jessica; Bagiella, Emilia; Najafian, Nader; Samaniego, Milagros; Djamali, Arjang; Alexander, Stephen I; Nankivell, Brian J; Chapman, Jeremy R; Smith, Rex Neal; Colvin, Robert; Murphy, Barbara

    2016-01-01

    Summary Background Chronic injury in kidney transplants remains a major cause of allograft loss. The aim of this study was to identify a gene set capable of predicting renal allografts at risk of progressive injury due to fibrosis. Methods This Genomics of Chronic Allograft Rejection (GoCAR) study is a prospective, multicentre study. We prospectively collected biopsies from renal allograft recipients (n=204) with stable renal function 3 months after transplantation. We used microarray analysis to investigate gene expression in 159 of these tissue samples. We aimed to identify genes that correlated with the Chronic Allograft Damage Index (CADI) score at 12 months, but not fibrosis at the time of the biopsy. We applied a penalised regression model in combination with permutation-based approach to derive an optimal gene set to predict allograft fibrosis. The GoCAR study is registered with ClinicalTrials.gov, number NCT00611702. Findings We identified a set of 13 genes that was independently predictive for the development of fibrosis at 1 year (ie, CADI-12 ≥2). The gene set had high predictive capacity (area under the curve [AUC] 0·967), which was superior to that of baseline clinical variables (AUC 0·706) and clinical and pathological variables (AUC 0·806). Furthermore routine pathological variables were unable to identify which histologically normal allografts would progress to fibrosis (AUC 0·754), whereas the predictive gene set accurately discriminated between transplants at high and low risk of progression (AUC 0·916). The 13 genes also accurately predicted early allograft loss (AUC 0·842 at 2 years and 0·844 at 3 years). We validated the predictive value of this gene set in an independent cohort from the GoCAR study (n=45, AUC 0·866) and two independent, publically available expression datasets (n=282, AUC 0·831 and n=24, AUC 0·972). Interpretation Our results suggest that this set of 13 genes could be used to identify kidney transplant recipients at

  16. The role of dosimetry audit in lung SBRT multi-centre clinical trials.

    Science.gov (United States)

    Clark, Catharine H; Hurkmans, Coen W; Kry, Stephen F

    2017-12-01

    Stereotactic Body Radiotherapy (SBRT) in the lung is a challenging technique which requires high quality clinical trials to answer the un-resolved clinical questions. Quality assurance of these clinical trials not only ensures the safety of the treatment of the participating patients but also minimises the variation in treatment, thus allowing the lowest number of patient treatments to answer the trial question. This review addresses the role of dosimetry audits in the quality assurance process and considers what can be done to ensure the highest accuracy of dose calculation and delivery and it's assessment in multi-centre trials. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  17. A teaching intervention in a contouring dummy run improved target volume delineation in locally advanced non-small cell lung cancer. Reducing the interobserver variability in multicentre clinical studies

    Energy Technology Data Exchange (ETDEWEB)

    Schimek-Jasch, Tanja; Prokic, Vesna; Doll, Christian; Grosu, Anca-Ligia; Nestle, Ursula [University Medical Center Freiburg, Department of Radiation Oncology, Freiburg (Germany); German Cancer Research Center (DKFZ), Heidelberg (Germany); German Cancer Consortium (DKTK) partner site: Freiburg, Heidelberg (Germany); Troost, Esther G.C. [Maastricht University Medical Centre, Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht (Netherlands); Ruecker, Gerta [University Medical Center Freiburg, Institute for Medical Biometry and Statistics, Centre for Medical Biometry and Medical Informatics, Freiburg (Germany); Avlar, Melanie [German Cancer Research Center (DKFZ), Heidelberg (Germany); Duncker-Rohr, Viola [Ortenau-Klinikum Offenburg-Gengenbach, Department of Radiation Oncology, Gengenbach (Germany); Mix, Michael [University Medical Center Freiburg, Department of Nuclear Medicine, Freiburg (Germany); German Cancer Research Center (DKFZ), Heidelberg (Germany); German Cancer Consortium (DKTK) partner site: Freiburg, Heidelberg (Germany)

    2015-02-10

    Interobserver variability in the definition of target volumes (TVs) is a well-known confounding factor in (multicentre) clinical studies employing radiotherapy. Therefore, detailed contouring guidelines are provided in the prospective randomised multicentre PET-Plan (NCT00697333) clinical trial protocol. This trial compares strictly FDG-PET-based TV delineation with conventional TV delineation in patients with locally advanced non-small cell lung cancer (NSCLC). Despite detailed contouring guidelines, their interpretation by different radiation oncologists can vary considerably, leading to undesirable discrepancies in TV delineation. Considering this, as part of the PET-Plan study quality assurance (QA), a contouring dummy run (DR) consisting of two phases was performed to analyse the interobserver variability before and after teaching. In the first phase of the DR (DR1), radiation oncologists from 14 study centres were asked to delineate TVs as defined by the study protocol (gross TV, GTV; and two clinical TVs, CTV-A and CTV-B) in a test patient. A teaching session was held at a study group meeting, including a discussion of the results focussing on discordances in comparison to the per-protocol solution. Subsequently, the second phase of the DR (DR2) was performed in order to evaluate the impact of teaching. Teaching after DR1 resulted in a reduction of absolute TVs in DR2, as well as in better concordance of TVs. The Overall Kappa(κ) indices increased from 0.63 to 0.71 (GTV), 0.60 to 0.65 (CTV-A) and from 0.59 to 0.63 (CTV-B), demonstrating improvements in overall interobserver agreement. Contouring DRs and study group meetings as part of QA in multicentre clinical trials help to identify misinterpretations of per-protocol TV delineation. Teaching the correct interpretation of protocol contouring guidelines leads to a reduction in interobserver variability and to more consistent contouring, which should consequently improve the validity of the overall study

  18. Does item overlap render measured relationships between pain and challenging behaviour trivial? Results from a multicentre cross-sectional study in 13 German nursing homes.

    Science.gov (United States)

    Kutschar, Patrick; Bauer, Zsuzsa; Gnass, Irmela; Osterbrink, Jürgen

    2017-07-01

    Several studies suggest that pain is a trigger for challenging behaviour in older adults with cognitive impairment. However, such measured relationships might be confounded due to item overlap as instruments share similar or identical items. The purpose of this study was to examine whether the frequently observed association between pain and challenging behaviour might be traced back to item overlap. This multicentre cross-sectional study was conducted in 13 nursing homes and examined pain (measure: Pain Assessment in Advanced Dementia Scale) and challenging behaviour (measure: Cohen-Mansfield Agitation Inventory) in 150 residents with severe cognitive impairment. The extent of item overlap was determined by juxtaposition of both measures' original items. As expected, comparison between these instruments revealed an extensive item overlap. The statistical relationship between the two phenomena can be traced back mainly to the contribution of the overlapping items, which renders the frequently stated relationship between pain and challenging behaviour trivial. The status quo of measuring such associations must be contested: constructs' discrimination and instruments' discrimination have to be discussed critically as item overlap may lead to biased conclusions and assumptions in research as well as to inadequate care measures in nursing practice. © 2017 John Wiley & Sons Ltd.

  19. DALI: Defining Antibiotic Levels in Intensive care unit patients: a multi-centre point of prevalence study to determine whether contemporary antibiotic dosing for critically ill patients is therapeutic.

    Science.gov (United States)

    Roberts, Jason A; De Waele, Jan J; Dimopoulos, George; Koulenti, Despoina; Martin, Claude; Montravers, Philippe; Rello, Jordi; Rhodes, Andrew; Starr, Therese; Wallis, Steven C; Lipman, Jeffrey

    2012-07-06

    The clinical effects of varying pharmacokinetic exposures of antibiotics (antibacterials and antifungals) on outcome in infected critically ill patients are poorly described. A large-scale multi-centre study (DALI Study) is currently underway describing the clinical outcomes of patients achieving pre-defined antibiotic exposures. This report describes the protocol. DALI will recruit over 500 patients administered a wide range of either beta-lactam or glycopeptide antibiotics or triazole or echinocandin antifungals in a pharmacokinetic point-prevalence study. It is anticipated that over 60 European intensive care units (ICUs) will participate. The primary aim will be to determine whether contemporary antibiotic dosing for critically ill patients achieves plasma concentrations associated with maximal activity. Secondary aims will compare antibiotic pharmacokinetic exposures with patient outcome and will describe the population pharmacokinetics of the antibiotics included. Various subgroup analyses will be conducted to determine patient groups that may be at risk of very low or very high concentrations of antibiotics. The DALI study should inform clinicians of the potential clinical advantages of achieving certain antibiotic pharmacokinetic exposures in infected critically ill patients.

  20. Optimal Chest Compression Rate and Compression to Ventilation Ratio in Delivery Room Resuscitation: Evidence from Newborn Piglets and Neonatal Manikins

    Science.gov (United States)

    Solevåg, Anne Lee; Schmölzer, Georg M.

    2017-01-01

    Cardiopulmonary resuscitation (CPR) duration until return of spontaneous circulation (ROSC) influences survival and neurologic outcomes after delivery room (DR) CPR. High quality chest compressions (CC) improve cerebral and myocardial perfusion. Improved myocardial perfusion increases the likelihood of a faster ROSC. Thus, optimizing CC quality may improve outcomes both by preserving cerebral blood flow during CPR and by reducing the recovery time. CC quality is determined by rate, CC to ventilation (C:V) ratio, and applied force, which are influenced by the CC provider. Thus, provider performance should be taken into account. Neonatal resuscitation guidelines recommend a 3:1 C:V ratio. CCs should be delivered at a rate of 90/min synchronized with ventilations at a rate of 30/min to achieve a total of 120 events/min. Despite a lack of scientific evidence supporting this, the investigation of alternative CC interventions in human neonates is ethically challenging. Also, the infrequent occurrence of extensive CPR measures in the DR make randomized controlled trials difficult to perform. Thus, many biomechanical aspects of CC have been investigated in animal and manikin models. Despite mathematical and physiological rationales that higher rates and uninterrupted CC improve CPR hemodynamics, studies indicate that provider fatigue is more pronounced when CC are performed continuously compared to when a pause is inserted after every third CC as currently recommended. A higher rate (e.g., 120/min) is also more fatiguing, which affects CC quality. In post-transitional piglets with asphyxia-induced cardiac arrest, there was no benefit of performing continuous CC at a rate of 90/min. Not only rate but duty cycle, i.e., the duration of CC/total cycle time, is a known determinant of CC effectiveness. However, duty cycle cannot be controlled with manual CC. Mechanical/automated CC in neonatal CPR has not been explored, and feedback systems are under-investigated in this

  1. A three-year follow-up on the efficacy of psychosocial interventions for patients with mild dementia and their caregivers: the multicentre, rater-blinded, randomized Danish Alzheimer Intervention Study (DAISY)

    DEFF Research Database (Denmark)

    Phung, K.T.T.; Waldorff, F.B.; Buss, D.V.

    2013-01-01

    OBJECTIVES: To examine the long-term efficacy at the 36-month follow-up of an early psychosocial counselling and support programme lasting 8-12 months for community-dwelling patients with mild Alzheimer's disease and their caregivers. DESIGN: Multicentre, randomised, controlled, rater-blinded trial....... SETTING: Primary care and memory clinics in five Danish districts. PARTICIPANTS: 330 home-dwelling patients with mild Alzheimer's disease and their primary caregivers (dyads). INTERVENTIONS: Dyads were randomised to receive intervention during the first year after diagnosis. Both intervention and control...... of Life Scale for Alzheimer's disease (QoL-AD), Neuropsychiatric Inventory-Questionnaire, Alzheimer's disease Cooperative Study Activities of Daily Living Scale, all-cause mortality and nursing home placement. RESULTS: At a 36-month follow-up, 2 years after the completion of the Danish Alzheimer...

  2. The importance of dietary change for men diagnosed with and at risk of prostate cancer: a multi-centre interview study with men, their partners and health professionals.

    Science.gov (United States)

    Avery, Kerry N L; Donovan, Jenny L; Horwood, Jeremy; Neal, David E; Hamdy, Freddie C; Parker, Chris; Wade, Julia; Lane, Athene

    2014-05-03

    The diagnosis of prostate cancer (PC) can provide a trigger for dietary change, and there is evidence that healthier diets may improve quality of life and clinical outcomes. However, men's views about dietary change in PC survivorship are largely unknown. This multi-centre qualitative interview study explored men's views about dietary change in PC survivorship, to better understand motivations for, and barriers to, achieving desired changes. The role of radical and active surveillance treatments on dietary change and the influence of men's partners were examined. Focus groups also evaluated stakeholder opinion, including healthcare professionals, about the provision of dietary advice to PC patients. A multi-centre interview study explored views about diet and motivations for, and barriers to, dietary change in men at elevated risk or diagnosed with PC following prostate specific antigen (PSA) testing. 58 men and 11 partners were interviewed. Interviews and focus groups were undertaken with 11 healthcare professionals, 5 patients and 4 partners to evaluate stakeholders' opinions about the feasibility and acceptability of providing dietary advice to PC patients. Data were analysed using methods of constant comparison and thematic analysis. Over half of diagnosed men reported making dietary changes, primarily to promote general or prostate health or facilitate coping, despite their uncertainty about diet-PC links. Interest in dietary advice was high. Information needs varied depending on treatment received, with men on active surveillance more frequently modifying their diet and regarding this as an adjunct therapy. Men considered their partners integral to implementing changes. Provision of dietary advice to men diagnosed with PC was considered by healthcare professionals and men to be feasible and appropriate in the context of a holistic 'care package'. Many men make positive dietary changes after PC diagnosis, which are perceived by men and their partners to bring

  3. Reliability of intra-oral quantitative sensory testing (QST) in patients with atypical odontalgia and healthy controls - a multicentre study.

    Science.gov (United States)

    Baad-Hansen, L; Pigg, M; Yang, G; List, T; Svensson, P; Drangsholt, M

    2015-02-01

    The reliability of comprehensive intra-oral quantitative sensory testing (QST) protocol has not been examined systematically in patients with chronic oro-facial pain. The aim of the present multicentre study was to examine test-retest and interexaminer reliability of intra-oral QST measures in terms of absolute values and z-scores as well as within-session coefficients of variation (CV) values in patients with atypical odontalgia (AO) and healthy pain-free controls. Forty-five patients with AO and 68 healthy controls were subjected to bilateral intra-oral gingival QST and unilateral extratrigeminal QST (thenar) on three occasions (twice on 1 day by two different examiners and once approximately 1 week later by one of the examiners). Intra-class correlation coefficients and kappa values for interexaminer and test-retest reliability were computed. Most of the standardised intra-oral QST measures showed fair to excellent interexaminer (9-12 of 13 measures) and test-retest (7-11 of 13 measures) reliability. Furthermore, no robust differences in reliability measures or within-session variability (CV) were detected between patients with AO and the healthy reference group. These reliability results in chronic orofacial pain patients support earlier suggestions based on data from healthy subjects that intra-oral QST is sufficiently reliable for use as a part of a comprehensive evaluation of patients with somatosensory disturbances or neuropathic pain in the trigeminal region. © 2014 John Wiley & Sons Ltd.

  4. Characteristics of acute treatment costs of traumatic brain injury in Eastern China--a multi-centre prospective observational study.

    Science.gov (United States)

    Yuan, Qiang; Liu, Hua; Wu, Xing; Sun, Yirui; Yao, Haijun; Zhou, Liangfu; Hu, Jin

    2012-12-01

    This study investigated acute treatment costs and related factors for traumatic brain injuries (TBI) in eastern China based on a prospective multicentre study. Data were prospectively collected from 80 hospitals in eastern China by standardized structured questionnaires during 2004. Included patients were admitted to hospitals via an emergency service with a diagnosis of TBI. The total acute hospitalization treatment costs derived from unsubsidized total hospital billings were used as the main outcome measure. Univariate and multivariable regression models were used to examine factors associated with each outcome. In total, 13,007 TBI cases were identified from 80 hospitals in eastern China. The median cost per hospitalization was $879 US (range, $72-45,894). The median cost per day was $79 (interquartile range, $49-126). The hospitalization costs varied based on the cause of TBI, with a median of $1017 for traffic accidents, $816 for falls, $490 for blows to the head, and $712 for falls. The hospitalization costs also varied by injury type with a mean of $918 for TBI associated with other injuries and $831 for isolated TBI. Using multiple regression analyses, lower admission Glasgow Coma score, longer hospital stay (LOS), male sex, transient patient status, traffic accident, injury occurring on a construction site, treatment at a tertiary hospital, neurosurgical intensive care unit (NICU) or ICU stay, associated polytrauma, and those who needed a neurosurgical operation had significantly higher total acute hospitalization costs than those of other groups. Good recovery and self-paying patients had lower total costs. A double LOS was associated with a 1.61 (95% confidence interval, 1.59-1.62) times higher hospital cost. Our results have potential implications for health-care resource planning during TBI treatment. Measures to prevent traffic accidents and reduce the LOS may help to reduce acute hospitalization costs. Crown Copyright © 2012. Published by Elsevier

  5. Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case-control study in the U.K.

    Science.gov (United States)

    Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

    2014-06-01

    Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the U.K. in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. A prospective multicentre case-control study was conducted at six U.K. hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  6. A multicentre molecular analysis of hepatitis B and blood-borne virus coinfections in Viet Nam.

    Science.gov (United States)

    Dunford, Linda; Carr, Michael J; Dean, Jonathan; Nguyen, Linh Thuy; Ta Thi, Thu Hong; Nguyen, Binh Thanh; Connell, Jeff; Coughlan, Suzie; Nguyen, Hien Tran; Hall, William W; Thi, Lan Anh Nguyen

    2012-01-01

    Hepatitis B (HBV) infection is endemic in Viet Nam, with up to 8.4 million individuals estimated to be chronically infected. We describe results of a large, multicentre seroepidemiological and molecular study of the prevalence of HBV infection and blood-borne viral coinfections in Viet Nam. Individuals with varying risk factors for infection (n = 8654) were recruited from five centres; Ha Noi, Hai Phong, Da Nang, Khanh Hoa and Can Tho. A mean prevalence rate of 10.7% was observed and levels of HBsAg were significantly higher in injecting drug users (IDUs) (17.4%, n = 174/1000) and dialysis patients (14.3%, n = 82/575) than in lower-risk groups (9.4%; pViet Nam and also highlights the significant levels of blood-borne virus coinfections, which have important implications for hepatitis-related morbidity and development of effective management strategies.

  7. A multi-centre cohort study shows no association between experienced violence and labour dystocia in nulliparous women at term

    Directory of Open Access Journals (Sweden)

    Dykes Anna-Karin

    2011-02-01

    Full Text Available Abstract Background Although both labour dystocia and domestic violence during pregnancy are associated with adverse maternal and fetal outcome, evidence in support of a possible association between experiences of domestic violence and labour dystocia is sparse. The aim of this study was to investigate whether self-reported history of violence or experienced violence during pregnancy is associated with increased risk of labour dystocia in nulliparous women at term. Methods A population-based multi-centre cohort study. A self-administrated questionnaire collected at 37 weeks of gestation from nine obstetric departments in Denmark. The total cohort comprised 2652 nulliparous women, among whom 985 (37.1% met the protocol criteria for dystocia. Results Among the total cohort, 940 (35.4% women reported experience of violence, and among these, 66 (2.5% women reported exposure to violence during their first pregnancy. Further, 39.5% (n = 26 of those had never been exposed to violence before. Univariate logistic regression analysis showed no association between history of violence or experienced violence during pregnancy and labour dystocia at term, crude OR 0.91, 95% CI (0.77-1.08, OR 0.90, 95% CI (0.54-1.50, respectively. However, violence exposed women consuming alcoholic beverages during late pregnancy had increased odds of labour dystocia, crude OR 1.45, 95% CI (1.07-1.96. Conclusions Our findings indicate that nulliparous women who have a history of violence or experienced violence during pregnancy do not appear to have a higher risk of labour dystocia at term, according to the definition of labour dystocia in this study. Additional research on this topic would be beneficial, including further evaluation of the criteria for labour dystocia.

  8. The MOAHLFA index of irritant sodium lauryl sulfate reactions: first results of a multicentre study on routine sodium lauryl sulfate patch testing.

    Science.gov (United States)

    Uter, Wolfgang; Geier, Johannes; Becker, Detlef; Brasch, Jochen; Löffler, Harald

    2004-01-01

    In a multicentre study of the German Contact Dermatitis Research Group, sodium lauryl sulfate (SLS) 0.25% and 0.5% aq. has been added to routine allergen patch tests to assess its properties as a convenient diagnostic indicator of individual susceptibility to irritation at the time of patch testing. Previous studies indicated that irritant SLS reactivity may be related to individual factors such as age and sex. As these factors are, in turn, among the important predictors of contact allergy to many allergens, e.g. summarized in the 'MOAHLFA index', the impact of the MOAHLFA factors on irritant SLS patch test reactivity, and thus a potential for confounding, was assessed in the 5971 participating patients. As a result of 2 logistic regression analyses with an irritant reaction to 0.25% and 0.5% SLS, respectively, as outcome, male sex was identified as a relatively weak but significant risk factor (OR 1.38), while age 40 years or older was an even weaker risk factor (OR 1.22 and 1.15, respectively). Upon detailed analysis, no clear age gradient could, however, be identified. 1-day exposure time almost halved the odds of an irritant SLS reaction. In conclusion, this type of SLS patch test can be regarded as robust, indicating individual irritability relatively independent from the individual factors analysed here.

  9. ASAP ECMO: Antibiotic, Sedative and Analgesic Pharmacokinetics during Extracorporeal Membrane Oxygenation: a multi-centre study to optimise drug therapy during ECMO

    Directory of Open Access Journals (Sweden)

    Shekar Kiran

    2012-11-01

    Full Text Available Abstract Background Given the expanding scope of extracorporeal membrane oxygenation (ECMO and its variable impact on drug pharmacokinetics as observed in neonatal studies, it is imperative that the effects of the device on the drugs commonly prescribed in the intensive care unit (ICU are further investigated. Currently, there are no data to confirm the appropriateness of standard drug dosing in adult patients on ECMO. Ineffective drug regimens in these critically ill patients can seriously worsen patient outcomes. This study was designed to describe the pharmacokinetics of the commonly used antibiotic, analgesic and sedative drugs in adult patients receiving ECMO. Methods/Design This is a multi-centre, open-label, descriptive pharmacokinetic (PK study. Eligible patients will be adults treated with ECMO for severe cardiac and/or respiratory failure at five Intensive Care Units in Australia and New Zealand. Patients will receive the study drugs as part of their routine management. Blood samples will be taken from indwelling catheters to investigate plasma concentrations of several antibiotics (ceftriaxone, meropenem, vancomycin, ciprofloxacin, gentamicin, piperacillin-tazobactum, ticarcillin-clavulunate, linezolid, fluconazole, voriconazole, caspofungin, oseltamivir, sedatives and analgesics (midazolam, morphine, fentanyl, propofol, dexmedetomidine, thiopentone. The PK of each drug will be characterised to determine the variability of PK in these patients and to develop dosing guidelines for prescription during ECMO. Discussion The evidence-based dosing algorithms generated from this analysis can be evaluated in later clinical studies. This knowledge is vitally important for optimising pharmacotherapy in these most severely ill patients to maximise the opportunity for therapeutic success and minimise the risk of therapeutic failure. Trial registration ACTRN12612000559819

  10. Serum C-reactive protein concentration as an indicator of remission status in dogs with multicentric lymphoma

    DEFF Research Database (Denmark)

    Nielsen, Lise; Toft, Nils; Eckersall, David

    2007-01-01

    Background: The acute-phase protein C-reactive protein (CRP) is used as a diagnostic and prognostic marker in humans with various neoplasias, including non-Hodgkin's lymphoma. Objective: To evaluate if CRP could be used to detect different remission states in dogs with lymphoma. Animals: Twenty......-two dogs with untreated multicentric lymphoma. Methods: Prospective observational study. Blood samples were collected at the time of diagnosis, before each chemotherapy session, and at follow-up visits, resulting in 287 serum samples. Results: Before therapy, a statistically significant majority...... of the dogs (P = .0019) had CRP concentrations above the reference range (68%, 15/22). After achieving complete remission 90% (18/20) of the dogs had CRP concentrations within the reference range, and the difference in values before and after treatment was statistically significant (P

  11. The effect of TCM acupuncture on hot flushes among menopausal women (ACUFLASH study: A study protocol of an ongoing multi-centre randomised controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Borud Einar K

    2007-02-01

    Full Text Available Abstract Background After menopause, 10–20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints. Methods/Design The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document ≥7 flushes/24 hours and who are not using hormone replacement therapy or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate. The treatment group receives 10 sessions of Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments. Discussion The study tests acupuncture as a complete treatment package including the therapeutic relationship and expectation. The intervention period lasts for 12 weeks, with follow up at 6 and 12 months. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life, assessed by the Women's Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway.

  12. Multicentric evaluation of the impact of central tumour location when comparing rates of N1 upstaging in patients undergoing video-assisted and open surgery for clinical Stage I non-small-cell lung cancer

    DEFF Research Database (Denmark)

    Decaluwé, Herbert; Petersen, René Horsleben; Brunelli, Alex

    2018-01-01

    OBJECTIVES: Large retrospective series have indicated lower rates of cN0 to pN1 nodal upstaging after video-assisted thoracic surgery (VATS) compared with open resections for Stage I non-small-cell lung cancer (NSCLC). The objective of our multicentre study was to investigate whether the presumed...

  13. Effects of periodontal treatment on carotid intima-media thickness in patients with lifestyle-related diseases: Japanese prospective multicentre observational study.

    Science.gov (United States)

    Kudo, Chieko; Shin, Wee Soo; Sasaki, Nobuhiro; Harai, Kazuo; Kato, Kai; Seino, Hiroaki; Goke, Eiji; Fujino, Takemasa; Kuribayashi, Nobuichi; Pearce, Youko Onuki; Taira, Masato; Matsushima, Ryoji; Minabe, Masato; Takashiba, Shogo

    2018-01-12

    Atherosclerosis, a chronic inflammatory disease in arterial blood vessels, is one of the major causes of death in worldwide. Meanwhile, periodontal disease is a chronic inflammatory disease caused by infection with periodontal pathogens such as P. gingivalis (Porphyromonas gingivalis). Several studies have reported association between periodontal infection and atherosclerosis, but direct investigation about the effects of periodontal treatment on atherosclerosis has not been reported. We have planned Japanese local clinics to determine the relationship between periodontal disease and atherosclerosis under collaborative with medical and dental care. A prospective, multicentre, observational study was conducted including 38 medical patients with lifestyle-related diseases in the stable period under consultation at participating medical clinics and 92 periodontal patients not undergoing medical treatment but who were consulting at participating dental clinics. Systemic and periodontal examinations were performed before and after periodontal treatment. At baseline, LDL-C (low-density lipoprotein cholesterol) levels and percentage (%) of mobile teeth were positively related to plasma IgG (immunoglobulin) antibody titer against P. gingivalis with multivariate analysis. Corresponding to improvements in periodontal clinical parameters after treatment, right and left max IMT (maximum intima-media thickness) levels were decreased significantly after treatment (SPT-S: start of supportive periodontal therapy, SPT-1y: at 1 year under SPT, and SPT-3y: at 3 years under SPT). The present study has clarified our previous univariate analysis results, wherein P. gingivalis infection was positively associated with progression of atherosclerosis. Thus, routine screening using plasma IgG antibody titer against P. gingivalis and periodontal treatment under collaborative with medical and dental care may prevent cardiovascular accidents caused by atherosclerosis.

  14. Ethical decision making in intensive care units: a burnout risk factor? Results from a multicentre study conducted with physicians and nurses.

    Science.gov (United States)

    Teixeira, Carla; Ribeiro, Orquídea; Fonseca, António M; Carvalho, Ana Sofia

    2014-02-01

    Ethical decision making in intensive care is a demanding task. The need to proceed to ethical decision is considered to be a stress factor that may lead to burnout. The aim of this study is to explore the ethical problems that may increase burnout levels among physicians and nurses working in Portuguese intensive care units (ICUs). A quantitative, multicentre, correlational study was conducted among 300 professionals. The most crucial ethical decisions made by professionals working in ICU were related to communication, withholding or withdrawing treatments and terminal sedation. A positive relation was found between ethical decision making and burnout in nurses, namely, between burnout and the need to withdraw treatments (p=0.032), to withhold treatments (p=0.002) and to proceed to terminal sedation (p=0.005). This did not apply to physicians. Emotional exhaustion was the burnout subdimension most affected by the ethical decision. The nurses' lack of involvement in ethical decision making was identified as a risk factor. Nevertheless, in comparison with nurses (6%), it was the physicians (34%) who more keenly felt the need to proceed to ethical decisions in ICU. Ethical problems were reported at different levels by physicians and nurses. The type of ethical decisions made by nurses working in Portuguese ICUs had an impact on burnout levels. This did not apply to physicians. This study highlights the need for education in the field of ethics in ICUs and the need to foster inter-disciplinary discussion so as to encourage ethical team deliberation in order to prevent burnout.

  15. The impact of incident fractures on health-related quality of life: 5 years of data from the Canadian Multicentre Osteoporosis Study.

    Science.gov (United States)

    Papaioannou, A; Kennedy, C C; Ioannidis, G; Sawka, A; Hopman, W M; Pickard, L; Brown, J P; Josse, R G; Kaiser, S; Anastassiades, T; Goltzman, D; Papadimitropoulos, M; Tenenhouse, A; Prior, J C; Olszynski, W P; Adachi, J D

    2009-05-01

    Using prospective data from the Canadian Multicentre Osteoporosis Study (CaMos), we compared health utilities index (HUI) scores after 5 years of follow-up among participants (50 years and older) with and without incident clinical fractures. Incident fractures had a negative impact on HUI scores over time. This study examined change in health-related quality of life (HRQL) in those with and without incident clinical fractures as measured by the HUI. The study cohort was 4,820 women and 1,783 men (50 years and older) from the CaMos. The HUI was administered at baseline and year 5. Participants were sub-divided into incident fracture groups (hip, rib, spine, forearm, pelvis, other) and were compared with those without these fractures. The effects of both time and fracture type on HUI scores were examined in multivariable regression analyses. Men and women with hip fractures, compared to those without, had lower HUI measures that ranged from -0.05 to -0.25. Both women and men with spine fractures had significant deficits on the pain attributes (-0.07 to -0.12). In women, self-care (-0.06), mobility and ambulation (-0.05) were also negatively impacted. Women with rib fractures had deficits similar to women with spine fractures, and these effects persisted over time. In men, rib fractures did not significantly affect HUI scores. Pelvic and forearm fractures did not substantially influence HUI scores. The HUI was a sensitive measure of HRQL change over time. These results will inform economic analyses evaluating osteoporosis therapies.

  16. The utility of e-Learning to support training for a multicentre bladder online adaptive radiotherapy trial (TROG 10.01-BOLART)

    International Nuclear Information System (INIS)

    Foroudi, Farshad; Pham, Daniel; Bressel, Mathias; Tongs, David; Rolfo, Aldo; Styles, Colin; Gill, Suki; Kron, Tomas

    2013-01-01

    Background and purpose: An e-Learning programme appeared useful for providing training and information regarding a multi-centre image guided radiotherapy trial. The aim of this study is to demonstrate the utility of this e-Learning programme. Materials and methods: Modules were created on relevant pelvic anatomy, Cone Beam CT soft tissue recognition and trial details. Radiation therapist participants’ knowledge and confidence were evaluated before, at the end of, and after at least 6 weeks of e-Learning (long term). Results: One hundred and eighty-five participants were recruited from 12 centres, with 118 in the first, and 67 in the second cohort. One hundred and forty-six participants had two tests (pre and post e-Learning) and 39 of these had three tests (pre, post, and long term). There was an increase confidence after completion of modules (p < 0.001). The first cohort pre scores increased from 67 ± 11 to 79 ± 8 (p < 0.001) post. The long term same question score was 73 ± 14 (p = 0.025, comparing to pre-test), and different questions’ score was 77 ± 13 (p = 0.014). In the second cohort, pre-test scores were 64 ± 10, post-test same question score 78 ± 9 (p < 0.001) and different questions’ score 81 ± 11 (p < 0.001). Conclusions: e-Learning for a multi-centre clinical trial was feasible and improved confidence and knowledge

  17. [Yeast urinary tract infections. Multicentre study in 14 hospitals belonging to the Buenos Aires City Mycology Network].

    Science.gov (United States)

    Maldonado, Ivana; Arechavala, Alicia; Guelfand, Liliana; Relloso, Silvia; Garbasz, Claudia

    2016-01-01

    Urinary tract infections are a frequent ailment in patients in intensive care units. Candida and other yeasts cause 5-12% of these infections. The value of the finding of any yeast is controversial, and there is no consensus about which parameters are adequate for differentiating urinary infections from colonization or contamination. To analyse the epidemiological characteristics of patients with funguria, to determine potential cut-off points in cultures (to distinguish an infection from other conditions), to identify the prevalent yeast species, and to determine the value of a second urine sample. A multicentre study was conducted in intensive care units of 14 hospitals in the Buenos Aires City Mycology Network. The first and second samples of urine from every patient were cultured. The presence of white cells and yeasts in direct examination, colony counts, and the identification of the isolated species, were evaluated. Yeasts grew in 12.2% of the samples. There was no statistical correlation between the number of white cells and the fungal colony-forming units. Eighty five percent of the patients had indwelling catheters. Funguria was not prevalent in women or in patients over the age of 65. Candida albicans, followed by Candida tropicalis, were the most frequently isolated yeasts. Candida parapsilosis and Candida glabrata appeared less frequently. The same species were isolated in 70% of second samples, and in 23% of the cases the second culture was negative. It was not possible to determine a useful cut-off point for colony counts to help in the diagnosis of urinary infections. As in other publications, C. albicans, followed by C. tropicalis, were the most prevalent species. Copyright © 2015 Asociación Española de Micología. Published by Elsevier Espana. All rights reserved.

  18. Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: a national multicentre study.

    Science.gov (United States)

    Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole; Behrendt, Nille; Klausen, Siri; Ramsing, Mette; Spaun, Eva; Hamilton-Dutoit, Stephen Jacques; Steiniche, Torben

    2012-02-01

    Metastasis size in melanoma sentinel lymph nodes (SLNs) is an emerging prognostic factor. Two European melanoma treatment trials include SLN metastasis diameters as inclusion criteria. Whilst diameter estimates are sensitive to the number of sections examined, the level of this bias is largely unknown. We performed a prospective multicentre study to compare the European Organisation for Research and Treatment of Cancer (EORTC) recommended protocol with a protocol of complete step-sectioning. One hundred and thirty-three consecutive SLNs from seven SLN centres were analysed by five central sections 50μm apart (EORTC Protocol) followed by complete 250μm step-sectioning. Overall, 29 patients (21.8%) were SLN-positive. The EORTC Protocol missed eight of these metastases (28%), one metastasis measuring less than 0.1mm in diameter, seven measuring between 0.1 and 1mm. Complete step-sectioning at 250μm intervals (Extensive Protocol) missed one metastasis (3%) that measured less than 0.1mm. Thirteen treatment courses (34%) performed if inclusion was based on the Combined Protocol would not be performed if assessed by the EORTC Protocol. Thus, 10 patients would be without completion lymph node dissection (EORTC MINITUB study), whilst three patients would not be eligible for anti-CTLA4 trial (EORTC protocol 18071). The corresponding number with the Extensive Protocol would be three; one patient for the MINITUB registration study and two patients for the anti-CTLA4 study. Examining SLNs by close central sectioning alone (EORTC Protocol) misses a substantial number of metastases and underestimates the maximum metastasis diameter, leading to important changes in patient eligibility for various treatment protocols. Copyright © 2011 Elsevier Ltd. All rights reserved.

  19. Distribution of Exhaled Contaminants and Personal Exposure in a Room using Three Different Air Distribution Strategies

    DEFF Research Database (Denmark)

    Olmedo, Inés; Nielsen, Peter V.; Adana, M. Ruiz de

    2012-01-01

    The level of exposure to human exhaled contaminants in a room depends not only on the air distribution system but also on people’s different positions, the distance between them, people’s activity level and height, direction of exhalation, and the surrounding temperature and temperature gradient...... between the manikins are changed to study the influence on the level of exposure. The results show that the air exhaled by a manikin flows a longer distance with a higher concentration in case of displacement ventilation than in the other two cases, indicating a significant exposure to the contaminants....... Human exhalation is studied in detail for different distribution systems: displacement and mixing ventilation as well as a system without mechanical ventilation. Two thermal manikins breathing through the mouth are used to simulate the exposure to human exhaled contaminants. The position and distance...

  20. Perspectives of Cosmesis following Breast Conservation for Multifocal and Multicentric Breast Cancers

    Directory of Open Access Journals (Sweden)

    Mona P. Tan

    2015-01-01

    Full Text Available Background. Contemporary data suggest that breast conservation treatment (BCT for multifocal and multicentric breast cancer (MFMCBC may be appropriate with noninferior local control rates. However, there is a paucity of data to evaluate patient’s satisfaction with cosmetic outcomes after BCT for MFMCBC. This study was performed to bridge this information gap. Methods. All patients treated at the authors’ healthcare facility were included in the study. Patients with MFMCBC who were assessed to be eligible for BCT underwent tumour resection using standard surgical techniques with direct parenchymal closure through a single incision. After at least three years of follow-up, they were invited to participate in a survey regarding their cosmetic outcomes. Results. Of a total of 160 patients, 40 had MFMCBC, of whom 34 (85% underwent successful BCT. Five-year cancer-specific survival and disease-free survival were 95.7%. Twenty of the 34 patients responded to the survey. No patient rated her cosmetic outcome as “poor.” Analysis indicated low agreement between patients’ self-assessment and clinician-directed evaluation of aesthetic results. Conclusion. BCT for MFMCBC is feasible with acceptable survival and cosmetic outcomes. However, there appears to be a disparity between patient and clinician-directed evaluation of cosmetic results which warrant further research.

  1. Repeatability and response to therapy of dynamic contrast-enhanced magnetic resonance imaging biomarkers in rheumatoid arthritis in a large multicentre trial setting

    Energy Technology Data Exchange (ETDEWEB)

    Waterton, John C. [University of Manchester, Stopford Building, Manchester Academic Health Sciences Centre, Manchester (United Kingdom); Personalised Healthcare and Biomarkers, AstraZeneca, Macclesfield (United Kingdom); Ho, Meilien [AstraZeneca, Global Medicines Development, Macclesfield (United Kingdom); Nordenmark, Lars H. [AstraZeneca, Global Medicines Development, Moelndal (Sweden); Jenkins, Martin [AstraZeneca, Global Medicines Development, Cambridge (United Kingdom); DiCarlo, Julie; Peterfy, Charles [Spire Sciences Inc, Boca Raton, FL (United States); Guillard, Gwenael; Bowes, Michael A. [Imorphics, Manchester (United Kingdom); Roberts, Caleb; Buonaccorsi, Giovanni [Bioxydyn, Manchester (United Kingdom); Parker, Geoffrey J.M. [University of Manchester, Stopford Building, Manchester Academic Health Sciences Centre, Manchester (United Kingdom); Bioxydyn, Manchester (United Kingdom); Kellner, Herbert [Private Practice and Division of Rheumatology KHI Neuwittelsbach, Muenchen (Germany); Taylor, Peter C. [University of Oxford, Kennedy Institute, Oxford (United Kingdom)

    2017-09-15

    To determine the repeatability and response to therapy of dynamic contrast-enhanced (DCE) MRI biomarkers of synovitis in the hand and wrist of rheumatoid arthritis (RA) patients, and in particular the performance of the transfer constant K{sup trans}, in a multicentre trial setting. DCE-MRI and RA MRI scoring (RAMRIS) were performed with meticulous standardisation at baseline and 6 and 24 weeks in a substudy of fostamatinib monotherapy in reducing synovitis compared with placebo or adalimumab. Analysis employed statistical shape modelling to avoid biased regions-of-interest, kinetic modelling and heuristic analyses. Repeatability was also evaluated. At early study termination, DCE-MRI data had been acquired from 58 patients in 19 imaging centres. K{sup trans} intra-subject coefficient of variation (N = 14) was 30%. K{sup trans} change demonstrated inferiority of fostamatinib (N = 11) relative to adalimumab (N = 10) after 6 weeks (treatment ratio = 1.92, p = 0.003), and failed to distinguish fostamatinib from placebo (N = 10, p = 0.79). RAMRIS showed superiority of fostamatinib relative to placebo at 6 weeks (p = 0.023), and did not distinguish fostamatinib from adalimumab at either 6 (p = 0.175) or 24 (p = 0.230) weeks. This demonstrated repeatability of K{sup trans} and its ability to distinguish treatment groups show that DCE-MRI biomarkers are suitable for use in multicentre RA trials. (orig.)

  2. Mid-term results of lateral unicondylar mobile bearing knee arthroplasty: a multicentre study of 363 cases.

    Science.gov (United States)

    Walker, T; Zahn, N; Bruckner, T; Streit, M R; Mohr, G; Aldinger, P R; Clarius, M; Gotterbarm, T

    2018-01-01

    The aim of this independent multicentre study was to assess the mid-term results of mobile bearing unicondylar knee arthroplasty (UKA) for isolated lateral osteoarthritis of the knee joint. We retrospectively evaluated 363 consecutive, lateral UKAs (346 patients) performed using the Oxford domed lateral prosthesis undertaken in three high-volume knee arthroplasty centres between 2006 and 2014. Mean age of the patients at surgery was 65 years (36 to 88) with a mean final follow-up of 37 months (12 to 93) RESULTS: A total of 36 (10.5%) patients underwent revision surgery, giving a survival rate of 90.1% at three years (95% confidence intervals (CI) 86.1 to 93.1; number at risk: 155) and 85.0% at five years (95% CI 77.9 to 89.9; number at risk: 43). Dislocation of the mobile bearing occurred in 18 patients (5.6%) at three years (95% CI 1.0 to 16.4; number at risk: 154) and in 20 patients (8.5%) at five years (95% CI 1.0 to 27.0; number at risk: 42). There were no significant differences in the dislocation rate between the participating centres or the surgeons. We were not able to identify an effect of each surgeon's learning curve on the dislocation rate of the mobile bearing. The clinical outcome in patients without revision surgery at final follow-up was good to excellent, with a mean Oxford knee score of 40.3 (95% CI 39.4 to 41.2), a mean Tegner activity score of 3.2 (95% CI 3.1 to 3.3) and a mean University of California, Los Angeles score of 5.7 (95% CI 5.5 to 5.9). Our data, which consists of a high number of patients treated with mobile bearing UKA in the lateral compartment, indicates a high revision rate of 15% at five years with dislocation of the mobile bearing being the main reason for implant failure. Despite the good functional and clinical results and the high patient satisfaction in our study group, we therefore discontinued using mobile-bearing lateral UKA in favour of a fixed-bearing component. Cite this article: Bone Joint J 2018;100-B:42-9. ©2018

  3. Protection Against Cross Infection in Hospital Beds with Integrated Personalized Ventilation

    DEFF Research Database (Denmark)

    Nielsen, Peter V.; Polak, Marcin; Jiang, Hao

    2008-01-01

    in this paper are carried out with tracer gas and two thermal manikins in the experimental SARS ward at Hong Kong University. One of the manikins is the source manikin, and the other one the target. The measurements show that a very high degree of protection can be obtained with this system. Optimum flow rate...... and temperature of the supply air are addressed in the research work....

  4. Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study.

    Science.gov (United States)

    Noriega, David; Krüger, Antonio; Ardura, Francisco; Hansen-Algenstaedt, Nils; Hassel, Frank; Barreau, Xavier; Beyerlein, Jörg

    2015-01-01

    The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

  5. Clinical Outcome after the Use of a New Craniocaudal Expandable Implant for Vertebral Compression Fracture Treatment: One Year Results from a Prospective Multicentric Study

    Directory of Open Access Journals (Sweden)

    David Noriega

    2015-01-01

    Full Text Available The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

  6. [Candidemias: multicentre analysis in 16 hospitals in Andalusia (Spain)].

    Science.gov (United States)

    Rodríguez-Hernández, M Jesús; Ruiz-Pérez de Pipaon, Maite; Márquez-Solero, Manuel; Martín-Rico, Patricia; Castón-Osorio, Juan José; Guerrero-Sánchez, Francisca M; Vidal-Verdú, Elisa; García-Figueras, Carolina; Del Arco-Jiménez, Alfonso; Rodríguez-Baño, Jesús; Martín-Mazuelos, Estrella; Cisneros-Herreros, José Miguel

    2011-05-01

    Candidemia is a nosocomial infection with high associated mortality. There have been changes in microbiology, epidemiology and treatment over the last few years, which has led us to analyse our own situation. Prospective, multicentre and observational study. All episodes of candidemia in adult patients seen in 17 Andalusian hospitals from 1 October 2005 to 30 September 2006 were included. Were detected 220 cases, the incidence was 0.58 cases/1,000 hospital discharges. Candida albicans was the most frecuent species (53% of cases). The majority of isolates (89%) was susceptibility to fluconazole. Sepsis was the most frequent clinical manifestation (65.7%). The treatment was inadequate in 38.7% of cases. Overall mortality was 40%. On univarite analysis death was found to be significantly associated with: aged > 60 years, unknown candidemia focus, Pitt score ≥ 2, APACHE II, shock at onset, persistents positive second blood cultures, non-removal of the central venous catheter and Candida species different of C. parasilopsis, among others. In the multivariate analysis death was found to be significantly associated with: aged > 60 years, Pitt score ≥ 2, Candida species different of C.parasilopsis and inadequate treatment. The candidemia clinical epidemiology in our region is similar to other areas and receiving inadequate treatment is the only modifiable risk factor associated with higher odds of mortality. Therefore, this modifiable factor needs to be improved to reduce the mortality. Copyright © 2010 Elsevier España, S.L. All rights reserved.

  7. The Thermal Plume above a Standing Human Body Exposed to Different Air Distribution Strategies

    DEFF Research Database (Denmark)

    Liu, Li; Nielsen, Peter V.; Li, Yuguo

    2009-01-01

    This study compares the impact of air distribution on the thermal plume above a human body in indoor environment. Three sets of measurements are conducted in a full-scale test room with different ventilation conditions. One breathing thermal manikin standing in the room is used to simulate...... the human body. Long-time average air velocity profiles at locations closely above the manikin are taken to identify the wandering thermal plume....

  8. Screening prior to biological therapy in Crohn's disease: adherence to guidelines and prevalence of infections. Results from a multicentre retrospective study.

    Science.gov (United States)

    van der Have, Mike; Belderbos, Tim D G; Fidder, Herma H; Leenders, Max; Dijkstra, Gerard; Peters, Charlotte P; Eshuis, Emma J; Ponsioen, Cyriel Y; Siersema, Peter D; van Oijen, Martijn G H; Oldenburg, Bas

    2014-10-01

    Screening for opportunistic infections prior to starting biological therapy in patients with inflammatory bowel disease is recommended. To assess adherence to screening for opportunistic infections prior to starting biological therapy in Crohn's disease patients and its yield. A multicentre retrospective study was conducted in Crohn's disease patients in whom infliximab or adalimumab was started between 2000 and 2010. Screening included tuberculin skin test, interferon-gamma release assay or chest X-ray for tuberculosis. Extended screening included screening for tuberculosis and viral infections. Patients were followed until three months after ending treatment. Primary endpoints were opportunistic and serious infections. 611 patients were included, 91% on infliximab. 463 (76%) patients were screened for tuberculosis, of whom 113 (24%) underwent extended screening. Screening for tuberculosis and hepatitis B increased to, respectively, 90-97% and 36-49% in the last two years. During a median follow-up of two years, 64/611 (9%, 3.4/100 patient-years) opportunistic infections and 26/611 (4%, 1.6/100 patient-years) serious infections were detected. Comorbidity was significantly associated with serious infections (hazard ratio 3.94). Although screening rates for tuberculosis and hepatitis B increased, screening for hepatitis B was still suboptimal. More caution is required when prescribing biologicals in patients with comorbid conditions. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  9. Does it matter if clinicians recruiting for a trial don't understand what the trial is really about? Qualitative study of surgeons' experiences of participation in a pragmatic multi-centre RCT

    Directory of Open Access Journals (Sweden)

    Snowdon Claire

    2007-01-01

    Full Text Available Abstract Background Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' understandings are inevitably influenced by the recruiting clinician's understanding of the trial, yet relatively little qualitative work has explored clinicians' perceptions and understandings of trials. This study interviewed surgeons shortly after the multi-centre, pragmatic RCT in which they had participated had been completed. Methods We used in-depth interviews with surgeons who participated in the Spine Stabilisation Trial (a pragmatic RCT to explore their understanding of the trial purpose and how this understanding had influenced their recruitment procedures and interpretation of the results. A purposive sample of eleven participating surgeons was chosen from 8 of the 15 UK trial centres. Results Although the surgeons thought that the trial was addressing an important question there was little agreement about what this question was: although it was a trial of 'equivalent' treatments, some thought that it was a trial of surgery, others a trial of rehabilitation and others that it was exploring what to do with patients in whom all other treatment options had been unsuccessful. The surgeons we interviewed were not aware of the rationale for the pragmatic inclusion criteria and nearly all were completely baffled about the meaning of 'equipoise'. Misunderstandings about the entry criteria were an important source of confusion about the results and led to reluctance to apply the results to their own practice. Conclusion The study suggests several lessons for the conduct of future multi-centre trials. Recruiting surgeons (and other clinicians may not be familiar with the rationale for pragmatic designs and may need to be regularly reminded about the purpose during the study. Reassurance may be necessary that a pragmatic

  10. Protocol for a multicentre, multistage, prospective study in China using system-based approaches for consistent improvement in surgical safety.

    Science.gov (United States)

    Yu, Xiaochu; Jiang, Jingmei; Liu, Changwei; Shen, Keng; Wang, Zixing; Han, Wei; Liu, Xingrong; Lin, Guole; Zhang, Ye; Zhang, Ying; Ma, Yufen; Bo, Haixin; Zhao, Yupei

    2017-06-15

    Surgical safety has emerged as a crucial global health issue in the past two decades. Although several safety-enhancing tools are available, the pace of large-scale improvement remains slow, especially in developing countries such as China. The present project (Modern Surgery and Anesthesia Safety Management System Construction and Promotion) aims to develop and validate system-based integrated approaches for reducing perioperative deaths and complications using a multicentre, multistage design. The project involves collection of clinical and outcome information for 1 20 000 surgical inpatients at four regionally representative academic/teaching general hospitals in China during three sequential stages: preparation and development, effectiveness validation and improvement of implementation for promotion. These big data will provide the evidence base for the formulation, validation and improvement processes of a system-based stratified safety intervention package covering the entire surgical pathway. Attention will be directed to managing inherent patient risks and regulating medical safety behaviour. Information technology will facilitate data collection and intervention implementation, provide supervision mechanisms and guarantee transfer of key patient safety messages between departments and personnel. Changes in rates of deaths, surgical complications during hospitalisation, length of stay, system adoption and implementation rates will be analysed to evaluate effectiveness and efficiency. This study was approved by the institutional review boards of Peking Union Medical College Hospital, First Hospital of China Medical University, Qinghai Provincial People's Hospital, Xiangya Hospital Central South University and the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences. Study findings will be disseminated via peer-reviewed journals, conference presentations and patent papers. © Article author(s) (or their employer(s) unless otherwise

  11. External validation of prognostic models to predict risk of gestational diabetes mellitus in one Dutch cohort: prospective multicentre cohort study.

    Science.gov (United States)

    Lamain-de Ruiter, Marije; Kwee, Anneke; Naaktgeboren, Christiana A; de Groot, Inge; Evers, Inge M; Groenendaal, Floris; Hering, Yolanda R; Huisjes, Anjoke J M; Kirpestein, Cornel; Monincx, Wilma M; Siljee, Jacqueline E; Van 't Zelfde, Annewil; van Oirschot, Charlotte M; Vankan-Buitelaar, Simone A; Vonk, Mariska A A W; Wiegers, Therese A; Zwart, Joost J; Franx, Arie; Moons, Karel G M; Koster, Maria P H

    2016-08-30

     To perform an external validation and direct comparison of published prognostic models for early prediction of the risk of gestational diabetes mellitus, including predictors applicable in the first trimester of pregnancy.  External validation of all published prognostic models in large scale, prospective, multicentre cohort study.  31 independent midwifery practices and six hospitals in the Netherlands.  Women recruited in their first trimester (diabetes mellitus of any type were excluded.  Discrimination of the prognostic models was assessed by the C statistic, and calibration assessed by calibration plots.  3723 women were included for analysis, of whom 181 (4.9%) developed gestational diabetes mellitus in pregnancy. 12 prognostic models for the disorder could be validated in the cohort. C statistics ranged from 0.67 to 0.78. Calibration plots showed that eight of the 12 models were well calibrated. The four models with the highest C statistics included almost all of the following predictors: maternal age, maternal body mass index, history of gestational diabetes mellitus, ethnicity, and family history of diabetes. Prognostic models had a similar performance in a subgroup of nulliparous women only. Decision curve analysis showed that the use of these four models always had a positive net benefit.  In this external validation study, most of the published prognostic models for gestational diabetes mellitus show acceptable discrimination and calibration. The four models with the highest discriminative abilities in this study cohort, which also perform well in a subgroup of nulliparous women, are easy models to apply in clinical practice and therefore deserve further evaluation regarding their clinical impact. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  12. Non conventional psychiatric rehabilitation in schizophrenia using therapeutic riding: the FISE multicentre Pindar project

    Directory of Open Access Journals (Sweden)

    Stefania Cerino

    2011-12-01

    Full Text Available The FISE (Federazione Italiana Sport Equestri Pindar is a multicentre research project aimed at testing the potential effects of therapeutic riding on schizophrenic patients. Twenty-four subjects with a diagnosis of schizophrenia were enrolled for a 1 year-treatment involving therapeutic riding sessions. All subjects were tested at the beginning and at the end of treatment with a series of validated test batteries (BPRS and 8 items-PANSS. The results discussed in this paper point out an improvement in negative symptoms, a constant disease remission in both early onset and chronic disease subjects, as well as a reduced rate of hospitalization.

  13. DALI: Defining Antibiotic Levels in Intensive care unit patients: a multi-centre point of prevalence study to determine whether contemporary antibiotic dosing for critically ill patients is therapeutic

    Directory of Open Access Journals (Sweden)

    Roberts Jason A

    2012-07-01

    Full Text Available Abstract Background The clinical effects of varying pharmacokinetic exposures of antibiotics (antibacterials and antifungals on outcome in infected critically ill patients are poorly described. A large-scale multi-centre study (DALI Study is currently underway describing the clinical outcomes of patients achieving pre-defined antibiotic exposures. This report describes the protocol. Methods DALI will recruit over 500 patients administered a wide range of either beta-lactam or glycopeptide antibiotics or triazole or echinocandin antifungals in a pharmacokinetic point-prevalence study. It is anticipated that over 60 European intensive care units (ICUs will participate. The primary aim will be to determine whether contemporary antibiotic dosing for critically ill patients achieves plasma concentrations associated with maximal activity. Secondary aims will compare antibiotic pharmacokinetic exposures with patient outcome and will describe the population pharmacokinetics of the antibiotics included. Various subgroup analyses will be conducted to determine patient groups that may be at risk of very low or very high concentrations of antibiotics. Discussion The DALI study should inform clinicians of the potential clinical advantages of achieving certain antibiotic pharmacokinetic exposures in infected critically ill patients.

  14. Impact of attenuation correction and gated acquisition in SPECT myocardial perfusion imaging: results of the multicentre SPAG (SPECT Attenuation Correction vs Gated) study

    International Nuclear Information System (INIS)

    Genovesi, Dario; Giorgetti, Assuero; Gimelli, Alessia; Kusch, Annette; D'Aragona Tagliavia, Irene; Casagranda, Mirta; Marzullo, Paolo; Cannizzaro, Giorgio; Giubbini, Raffaele; Bertagna, Francesco; Fagioli, Giorgio; Rossi, Massimiliano; Romeo, Annadina; Bertolaccini, Pietro; Bonini, Rita

    2011-01-01

    In clinical myocardial single photon emission computed tomography (SPECT), attenuation artefacts may cause a loss of specificity in the identification of diseased vessels that can be corrected by means of gated SPECT (GSPECT) acquisition or CT attenuation correction (AC). The purpose of this multicentre study was to assess the impact of GSPECT and AC on the diagnostic performance of myocardial scintigraphy, according to patient's sex, body mass index (BMI) and site of coronary artery disease (CAD). We studied a group of 104 patients who underwent coronary angiography within 1 month before or after the SPECT study. Patients with a BMI > 27 were considered ''overweight''. Attenuation-corrected and standard GSPECT early images were randomly interpreted by three readers blinded to the clinical data. In the whole group, GSPECT and AC showed a diagnostic accuracy of 86.5% (sensitivity 82%, specificity 93%) and 77% (sensitivity 75.4%, specificity 81.4%), respectively (p < 0.05). In women, when anterior ischaemia was matched with CAD, AC failed to show any increase in specificity (AC 63.6% vs GSPECT 63.6%) with evident loss of sensitivity (AC 72.7% vs GSPECT 90.9%). AC significantly improved SPECT specificity in the identification of right CAD in overweight men (AC 100% vs GSPECT 66.7%, p <0.05). AC improved specificity in the evaluation of right CAD in overweight men. In the other evaluable subgroups specificity was not significantly affected while sensitivity was frequently reduced. (orig.)

  15. Impact of attenuation correction and gated acquisition in SPECT myocardial perfusion imaging: results of the multicentre SPAG (SPECT Attenuation Correction vs Gated) study

    Energy Technology Data Exchange (ETDEWEB)

    Genovesi, Dario; Giorgetti, Assuero; Gimelli, Alessia; Kusch, Annette; D' Aragona Tagliavia, Irene; Casagranda, Mirta; Marzullo, Paolo [Fondazione CNR-Regione Toscana ' ' G. Monasterio' ' , Nuclear Medicine, Pisa (Italy); Cannizzaro, Giorgio [A.O.V. Cervello, Nuclear Medicine, Palermo (Italy); Giubbini, Raffaele; Bertagna, Francesco [Spedali Civili, Nuclear Medicine, Brescia (Italy); Fagioli, Giorgio; Rossi, Massimiliano; Romeo, Annadina [Ospedale Maggiore, Nuclear Medicine, Bologna (Italy); Bertolaccini, Pietro; Bonini, Rita [Ospedale SS Giacomo e Cristoforo, Nuclear Medicine, Massa (Italy)

    2011-10-15

    In clinical myocardial single photon emission computed tomography (SPECT), attenuation artefacts may cause a loss of specificity in the identification of diseased vessels that can be corrected by means of gated SPECT (GSPECT) acquisition or CT attenuation correction (AC). The purpose of this multicentre study was to assess the impact of GSPECT and AC on the diagnostic performance of myocardial scintigraphy, according to patient's sex, body mass index (BMI) and site of coronary artery disease (CAD). We studied a group of 104 patients who underwent coronary angiography within 1 month before or after the SPECT study. Patients with a BMI > 27 were considered ''overweight''. Attenuation-corrected and standard GSPECT early images were randomly interpreted by three readers blinded to the clinical data. In the whole group, GSPECT and AC showed a diagnostic accuracy of 86.5% (sensitivity 82%, specificity 93%) and 77% (sensitivity 75.4%, specificity 81.4%), respectively (p < 0.05). In women, when anterior ischaemia was matched with CAD, AC failed to show any increase in specificity (AC 63.6% vs GSPECT 63.6%) with evident loss of sensitivity (AC 72.7% vs GSPECT 90.9%). AC significantly improved SPECT specificity in the identification of right CAD in overweight men (AC 100% vs GSPECT 66.7%, p <0.05). AC improved specificity in the evaluation of right CAD in overweight men. In the other evaluable subgroups specificity was not significantly affected while sensitivity was frequently reduced. (orig.)

  16. Multicentre prospective evaluation of implant-assisted mandibular removable partial dentures: surgical and prosthodontic outcomes.

    Science.gov (United States)

    Payne, Alan G T; Tawse-Smith, Andrew; Wismeijer, Daniel; De Silva, Rohana K; Ma, Sunyoung

    2017-01-01

    To determine implant survival and prosthodontic maintenance of implant-assisted mandibular removable partial dentures in a multicentre prospective study up to 10 years. Forty-eight participants with mandibular distal extension partial dentures were selected. A control group of 12 New Zealand participants had new conventional mandibular partial dentures made. Three test groups of 36 participants in New Zealand (n = 12), the Netherlands (n = 12) and Colombia (n = 12) had bilateral distal implants placed. Surgical and prosthodontic outcomes were documented with only healing caps placed (Stage 1) and with an attachment system (Stage 2). No implants failed after 3 years. Four late implant failures in three participants occurred in New Zealand (two unilateral implant failures after 5 and 8 years and two bilateral implant failures in the same participant after 6 and 10 years); two unilateral late implant failures occurred in the Netherlands and no late failures in Colombia. Implant survival rate was 92% by 10 years. Resonance frequency measurements were taken at surgery implant stability quotient (ISQ) 62.44 ± 7.46; range 40 - 79), baseline (ISQ 63.22 ± 6.17; range 50 - 74) and after 3 years (ISQ 66.38 ± 6.77; range 55 - 83). In New Zealand and Colombia, measured crestal bone levels were 2.03 ± 0.71 mm and 2.20 ± 0.81 mm, respectively, at baseline and 3 years. For Stage I, principal prosthodontic maintenance issues were loose healing caps among 10 New Zealand participants, four Colombian participants and one Netherlands participant. For Stage 2, matrix activation and overdenture puncture fractures resulted in 41 events (25 participants) in New Zealand over 10 years, whilst over 3 years, there were 14 events in nine Colombian participants and six events in five Netherlands participants. This clinical multicentre research complements previous case reports, case series, retrospective and prospective studies on the notion of implant

  17. Validation of the 24-item recovery assessment scale-revised (RAS-R) in the Norwegian language and context: a multi-centre study.

    Science.gov (United States)

    Biringer, Eva; Tjoflåt, Marit

    2018-01-25

    The Recovery Assessment Scale-revised (RAS-R) is a self-report instrument measuring mental health recovery. The purpose of the present study was to translate and adapt the RAS-R into the Norwegian language and to investigate its psychometric properties in terms of factor structure, convergent and discriminant validity and reliability in the Norwegian context. The present study is a cross-sectional multi-centre study. After a pilot test, the Norwegian version of the RAS-R was distributed to 231 service users in mental health specialist and community services. The factor structure of the instrument was investigated by a confirmatory factor analysis (CFA), and internal consistency was assessed by Cronbach's alpha. The RAS-R was found to be acceptable and feasible for service users. The original five-factor structure was confirmed. All model fit indices, including the standardised root mean square residual (SRMR), which is independent of the χ 2 -test, met the criteria for an acceptable model fit. Internal consistencies within sub-scales as measured by Cronbach's alpha ranged from 0.65 to 0.85. Cronbach's alpha for the total scale was 0.90. As expected, some redundancy between factors existed (in particular among the factors Personal confidence and hope, Goal and success orientation and Not dominated by symptoms). The Norwegian RAS-R showed acceptable psychometric properties in terms of convergent validity and reliability, and fit indices from the CFA confirmed the original factor structure. We recommend the Norwegian RAS-R as a tool in service users' and health professionals' collaborative work towards the service users' recovery goals and as an outcome measure in larger evaluations.

  18. The CAIRO4 study

    DEFF Research Database (Denmark)

    't Lam-Boer, Jorine; Mol, Linda; Verhoef, Cornelis

    2015-01-01

    stages of the disease. We here propose a randomized trial in order to demonstrate that resection of the primary tumour improves overall survival. METHODS/DESIGN: The CAIRO4 study is a multicentre, randomized, phase III study of the Dutch Colorectal Cancer Group (DCCG). Patients with synchronous...... objective of this study is to determine the clinical benefit in terms of overall survival of initial resection of the primary tumour. Secondary endpoints include progression free survival, surgical morbidity, quality of life and the number of patients requiring resection of the primary tumour in the control...... arm. DISCUSSION: The CAIRO4 study is a multicentre, randomized, phase III study that will assess the benefit of resection of the primary tumour in patients with synchronous metastatic CRC. TRIAL REGISTRATION: The CAIRO4 study is registered at clinicaltrials.gov (NCT01606098)....

  19. Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

    Science.gov (United States)

    Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

    2015-01-01

    Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

  20. Validation of SAPS3 admission score and its customization for use in Korean intensive care unit patients: a prospective multicentre study.

    Science.gov (United States)

    Lim, So Yeon; Koh, Shin Ok; Jeon, Kyeongman; Na, Sungwon; Lim, Chae-Man; Choi, Won-Il; Lee, Young-Joo; Kim, Seok Chan; Chon, Gyu Rak; Kim, Je Hyeong; Kim, Jae Yeol; Lim, Jaemin; Rhee, Chin Kook; Park, Sunghoon; Kim, Ho Cheol; Lee, Jin Hwa; Lee, Ji Hyun; Park, Jisook; Koh, Younsuck; Suh, Gee Young

    2013-08-01

    To externally validate the simplified acute physiology score 3 (SAPS3) and to customize it for use in Korean intensive care unit (ICU) patients. This is a prospective multicentre cohort study involving 22 ICUs from 15 centres throughout Korea. The study population comprised patients who were consecutively admitted to participating ICUs from 1 July 2010 to 31 January 2011. A total of 4617 patients were enrolled. ICU mortality was 14.3%, and hospital mortality was 20.6%. The patients were randomly assigned into one of two cohorts: a development (n = 2309) or validation (n = 2308) cohort. In the development cohort, the general SAPS3 had good discrimination (area under the receiver operating characteristics curve = 0.829), but poor calibration (Hosmer-Lemeshow goodness-of-fit test H = 123.06, P Customization was achieved by altering the logit of the original SAPS3 equation. The new equation for Korean ICU patients was validated in the validation cohort, and demonstrated both good discrimination (area under the receiver operating characteristics curve = 0.835) and good calibration (H = 4.61, P = 0.799, C = 5.67, P = 0.684). General and regional Australasia SAPS3 admission scores showed poor calibration for use in Korean ICU patients, but the prognostic power of the SAPS3 was significantly improved by customization. Prediction models should be customized before being used to predict mortality in different regions of the world. © 2013 The Authors. Respirology © 2013 Asian Pacific Society of Respirology.

  1. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

    Directory of Open Access Journals (Sweden)

    Norrie John

    2010-04-01

    Full Text Available Abstract Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676

  2. Sensitivity of enhanced MRI for the detection of breast cancer: new, multicentric, residual, and recurrent

    International Nuclear Information System (INIS)

    Davis, P.L.; McCarty, K.S. Jr.

    1997-01-01

    Magnetic resonance imaging (MRI) of the breast brings the advantages of high resolution cross-sectional imaging to breast cancer diagnosis, treatment and research: improved cancer detection, staging, selection of therapy, evaluation of therapeutic response in vivo, detection of recurrence, and even the development of new therapies. Until now breast cancer treatment and research has been impeded by the limited means of evaluating the breast cancer in vivo: primarily clinical palpation and mammography of the breast tumor. A review of the initial studies shows that with the use of paramagnetic contrast agents, MRI has a sensitivity of 96 % for detecting breast cancers. MRI detects multicentric disease with a sensitivity of 98 %, superior to any other modality. The ability of MRI to detect recurrent local breast cancer in the conservatively treated breast is nearly 100 %. MRI is capable of monitoring tumor response to chemotherapy and actually guiding therapeutic interventions such as interstitial laser photocoagulation. (orig.)

  3. The relationship between proton pump inhibitor use and longitudinal change in bone mineral density: a population-based study [corrected] from the Canadian Multicentre Osteoporosis Study (CaMos).

    Science.gov (United States)

    Targownik, Laura E; Leslie, William D; Davison, K Shawn; Goltzman, David; Jamal, Sophie A; Kreiger, Nancy; Josse, Robert G; Kaiser, Stephanie M; Kovacs, Christopher S; Prior, Jerilynn C; Zhou, Wei

    2012-09-01

    Proton pump inhibitor (PPI) use has been identified as a risk factor for hip and vertebral fractures. Evidence supporting a relationship between PPI use and osteoporosis remains scant. Demonstrating that PPIs are associated with accelerated bone mineral density (BMD) loss would provide supportive evidence for a mechanism through which PPIs could increase fracture risk. We used the Canadian Multicentre Osteoporosis Study data set, which enrolled a population-based sample of Canadians who underwent BMD testing of the femoral neck, total hip, and lumbar spine (L1-L4) at baseline, and then again at 5 and 10 years. Participants also reported drug use and exposure to risk factors for osteoporosis and fracture. Multivariate linear regression was used to determine the independent association of PPI exposure and baseline BMD, and on change in BMD at 5 and 10 years. In all, 8,340 subjects were included in the baseline analysis, with 4,512 (55%) undergoing year 10 BMD testing. After adjusting for potential confounders, PPI use was associated with significantly lower baseline BMD at the femoral neck and total hip. PPI use was not associated with a significant acceleration in covariate-adjusted BMD loss at any measurement site after 5 and 10 years of follow-up. PPI users had lower BMD at baseline than PPI non-users, but PPI use over 10 years did not appear to be associated with accelerated BMD loss. The reasons for discordant findings between PPI use at baseline and during follow-up require further study.

  4. CoDuSe group exercise programme improves balance and reduces falls in people with multiple sclerosis: A multi-centre, randomized, controlled pilot study.

    Science.gov (United States)

    Carling, Anna; Forsberg, Anette; Gunnarsson, Martin; Nilsagård, Ylva

    2017-09-01

    Imbalance leading to falls is common in people with multiple sclerosis (PwMS). To evaluate the effects of a balance group exercise programme (CoDuSe) on balance and walking in PwMS (Expanded Disability Status Scale, 4.0-7.5). A multi-centre, randomized, controlled single-blinded pilot study with random allocation to early or late start of exercise, with the latter group serving as control group for the physical function measures. In total, 14 supervised 60-minute exercise sessions were delivered over 7 weeks. Pretest-posttest analyses were conducted for self-reported near falls and falls in the group starting late. Primary outcome was Berg Balance Scale (BBS). A total of 51 participants were initially enrolled; three were lost to follow-up. Post-intervention, the exercise group showed statistically significant improvement ( p = 0.015) in BBS and borderline significant improvement in MS Walking Scale ( p = 0.051), both with large effect sizes (3.66; -2.89). No other significant differences were found between groups. In the group starting late, numbers of falls and near falls were statistically significantly reduced after exercise compared to before ( p balance and reduced perceived walking limitations, compared to no exercise. The intervention reduced falls and near falls frequency.

  5. A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration.

    Science.gov (United States)

    van Asten, Freekje; Evers-Birkenkamp, Kim U; van Lith-Verhoeven, Janneke J C; de Jong-Hesse, Yvonne; Hoppenreijs, Vincent P T; Hommersom, Richard F; Scholten, Agnes M; Hoyng, Carel B; Klaver, Johannes H J

    2015-03-01

    The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. The HELIOS study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  6. Socio-demographic and clinical determinants of self-care in adults with type 2 diabetes: a multicentre observational study.

    Science.gov (United States)

    Ausili, Davide; Rossi, Emanuela; Rebora, Paola; Luciani, Michela; Tonoli, Luca; Ballerini, Enrico; Androni, Silvia; Vellone, Ercole; Riegel, Barbara; Di Mauro, Stefania

    2018-04-05

    To describe self-care as defined by the Middle Range Theory of Self-Care of Chronic Illness and to identify clinical and socio-demographic determinants in a T2DM population. A multicentre observational cross-sectional study was conducted involving 540 adults with a confirmed diagnosis of T2DM from six outpatient diabetes services in Italy. Socio-demographic and clinical data were collected from medical records. The Self-Care of Diabetes Inventory (SCODI) was used to measure self-care maintenance, monitoring, management, and confidence dimensions. For each separate scale, scores were standardized 0-100 with higher SCODI scores indicating better self-care; a score ≥ 70 is adequate. Multiple quantile regression models were performed to identify determinants of each self-care dimension. Self-care maintenance (median = 81.3) and self-care confidence (median = 79.5) were adequate in most of the subjects. Self-care monitoring was adequate in only half of the sample (median = 70.6). Self-care management was poor (median = 59.4). Lower self-care maintenance was associated with lower self-care confidence (p self-care monitoring was associated with being male (p self-care confidence (p diabetes for self-care management was associated with being male (p = 0.002), being older (p = 0.005), having a low income (p = 0.030), being employed (p = 0.008), having missed diabetes education in the last year (p = 0.002), and lower self-care confidence (p self-care confidence was associated with having diabetes for self-care maintenance, monitoring, management and confidence include both clinical and socio-demographic variables. Modifiable determinants such as self-care confidence and diabetes self-care management education could be used to tailor interventions to improve diabetes self-care.

  7. Perception and use of massive open online courses among medical students in a developing country: multicentre cross-sectional study

    Science.gov (United States)

    Aboshady, Omar A; Radwan, Ahmed E; Eltaweel, Asmaa R; Azzam, Ahmed; Aboelnaga, Amr A; Hashem, Heba A; Darwish, Salma Y; Salah, Rehab; Kotb, Omar N; Afifi, Ahmed M; Noaman, Aya M; Salem, Dalal S; Hassouna, Ahmed

    2015-01-01

    Objectives To assess the prevalence of awareness and use of massive open online courses (MOOCs) among medical undergraduates in Egypt as a developing country, as well as identifying the limitations and satisfaction of using these courses. Design A multicentre, cross-sectional study using a web-based, pilot-tested and self-administered questionnaire. Settings Ten out of 19 randomly selected medical schools in Egypt. Participants 2700 undergraduate medical students were randomly selected, with an equal allocation of participants in each university and each study year. Primary and secondary outcome measures Primary outcome measures were the percentages of students who knew about MOOCs, students who enrolled and students who obtained a certificate. Secondary outcome measures included the limitations and satisfaction of using MOOCs through five-point Likert scale questions. Results Of 2527 eligible students, 2106 completed the questionnaire (response rate 83.3%). Of these students, 456 (21.7%) knew the term MOOCs or websites providing these courses. Out of the latter, 136 (29.8%) students had enrolled in at least one course, but only 25 (18.4%) had completed courses earning certificates. Clinical year students showed significantly higher rates of knowledge (p=0.009) and enrolment (p<0.001) than academic year students. The primary reasons for the failure of completion of courses included lack of time (105; 77.2%) and slow Internet speed (73; 53.7%). Regarding the 25 students who completed courses, 21 (84%) were satisfied with the overall experience. However, there was less satisfaction regarding student–instructor (8; 32%) and student–student (5; 20%) interactions. Conclusions About one-fifth of Egyptian medical undergraduates have heard about MOOCs with only about 6.5% actively enrolled in courses. Students who actively participated showed a positive attitude towards the experience, but better time-management skills and faster Internet connection speeds are required

  8. Unified analytical treatment of multicentre electron attraction, electric field and electric field gradient integrals over Slater orbitals

    International Nuclear Information System (INIS)

    Guseinov, I I

    2004-01-01

    The new central and noncentral potential functions (CPFs and NCPFs) of a molecule depending on the coordinates of the nuclei are introduced. Using complete orthonormal sets of Ψ α -exponential-type orbitals (Ψ α -ETOs) introduced by the author, the series expansion formulae for the multicentre electronic attraction (EA), electric field (EF) and electric field gradient (EFG) integrals over Slater-type orbitals (STOs) in terms of CPFs and NCPFs are derived. The relationships obtained are valid for the arbitrary location, quantum numbers and screening constants of STOs

  9. Magnetic Resonance Parkinsonism Index: diagnostic accuracy of a fully automated algorithm in comparison with the manual measurement in a large Italian multicentre study in patients with progressive supranuclear palsy

    International Nuclear Information System (INIS)

    Nigro, Salvatore; Arabia, Gennarina; Antonini, Angelo; Weis, Luca; Marcante, Andrea; Tessitore, Alessandro; Cirillo, Mario; Tedeschi, Gioacchino; Zanigni, Stefano; Tonon, Caterina; Calandra-Buonaura, Giovanna; Pezzoli, Gianni; Cilia, Roberto; Zappia, Mario; Nicoletti, Alessandra; Cicero, Calogero Edoardo; Tinazzi, Michele; Tocco, Pierluigi; Cardobi, Nicolo; Quattrone, Aldo

    2017-01-01

    To investigate the reliability of a new in-house automatic algorithm for calculating the Magnetic Resonance Parkinsonism Index (MRPI), in a large multicentre study population of patients affected by progressive supranuclear palsy (PSP) or Parkinson's disease (PD), and healthy controls (HC), and to compare the diagnostic accuracy of the automatic and manual MRPI values. The study included 88 PSP patients, 234 PD patients and 117 controls. MRI was performed using both 3T and 1.5T scanners. Automatic and manual MRPI values were evaluated, and accuracy of both methods in distinguishing PSP from PD and controls was calculated. No statistical differences were found between automated and manual MRPI values in all groups. The automatic MRPI values differentiated PSP from PD with an accuracy of 95 % (manual MRPI accuracy 96 %) and 97 % (manual MRPI accuracy 100 %) for 1.5T and 3T scanners, respectively. Our study showed that the new in-house automated method for MRPI calculation was highly accurate in distinguishing PSP from PD. Our automatic approach allows a widespread use of MRPI in clinical practice and in longitudinal research studies. (orig.)

  10. Magnetic Resonance Parkinsonism Index: diagnostic accuracy of a fully automated algorithm in comparison with the manual measurement in a large Italian multicentre study in patients with progressive supranuclear palsy

    Energy Technology Data Exchange (ETDEWEB)

    Nigro, Salvatore [National Research Council, Institute of Bioimaging and Molecular Physiology, Catanzaro (Italy); Arabia, Gennarina [University ' ' Magna Graecia' ' , Institute of Neurology, Department of Medical and Surgical Sciences, Catanzaro (Italy); Antonini, Angelo; Weis, Luca; Marcante, Andrea [' ' Fondazione Ospedale San Camillo' ' - I.R.C.C.S, Parkinson' s Disease and Movement Disorders Unit, Venice-Lido (Italy); Tessitore, Alessandro; Cirillo, Mario; Tedeschi, Gioacchino [Second University of Naples, Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, Naples (Italy); Second University of Naples, MRI Research Center SUN-FISM, Naples (Italy); Zanigni, Stefano; Tonon, Caterina [Policlinico S. Orsola - Malpighi, Functional MR Unit, Bologna (Italy); University of Bologna, Department of Biomedical and Neuromotor Sciences, Bologna (Italy); Calandra-Buonaura, Giovanna [University of Bologna, Department of Biomedical and Neuromotor Sciences, Bologna (Italy); IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna (Italy); Pezzoli, Gianni; Cilia, Roberto [ASST G.Pini - CTO, ex ICP, Parkinson Institute, Milano (Italy); Zappia, Mario; Nicoletti, Alessandra; Cicero, Calogero Edoardo [University of Catania, Department ' ' G.F. Ingrassia' ' , Section of Neurosciences, Catania (Italy); Tinazzi, Michele; Tocco, Pierluigi [University Hospital of Verona, Department of Neurological and Movement Sciences, Verona (Italy); Cardobi, Nicolo [University Hospital of Verona, Institute of Radiology, Verona (Italy); Quattrone, Aldo [National Research Council, Institute of Bioimaging and Molecular Physiology, Catanzaro (Italy); University ' ' Magna Graecia' ' , Institute of Neurology, Department of Medical and Surgical Sciences, Catanzaro (Italy)

    2017-06-15

    To investigate the reliability of a new in-house automatic algorithm for calculating the Magnetic Resonance Parkinsonism Index (MRPI), in a large multicentre study population of patients affected by progressive supranuclear palsy (PSP) or Parkinson's disease (PD), and healthy controls (HC), and to compare the diagnostic accuracy of the automatic and manual MRPI values. The study included 88 PSP patients, 234 PD patients and 117 controls. MRI was performed using both 3T and 1.5T scanners. Automatic and manual MRPI values were evaluated, and accuracy of both methods in distinguishing PSP from PD and controls was calculated. No statistical differences were found between automated and manual MRPI values in all groups. The automatic MRPI values differentiated PSP from PD with an accuracy of 95 % (manual MRPI accuracy 96 %) and 97 % (manual MRPI accuracy 100 %) for 1.5T and 3T scanners, respectively. Our study showed that the new in-house automated method for MRPI calculation was highly accurate in distinguishing PSP from PD. Our automatic approach allows a widespread use of MRPI in clinical practice and in longitudinal research studies. (orig.)

  11. Computerized detection of breast lesions in multi-centre and multi-instrument DCE-MR data using 3D principal component maps and template matching

    Science.gov (United States)

    Ertas, Gokhan; Doran, Simon; Leach, Martin O.

    2011-12-01

    In this study, we introduce a novel, robust and accurate computerized algorithm based on volumetric principal component maps and template matching that facilitates lesion detection on dynamic contrast-enhanced MR. The study dataset comprises 24 204 contrast-enhanced breast MR images corresponding to 4034 axial slices from 47 women in the UK multi-centre study of MRI screening for breast cancer and categorized as high risk. The scans analysed here were performed on six different models of scanner from three commercial vendors, sited in 13 clinics around the UK. 1952 slices from this dataset, containing 15 benign and 13 malignant lesions, were used for training. The remaining 2082 slices, with 14 benign and 12 malignant lesions, were used for test purposes. To prevent false positives being detected from other tissues and regions of the body, breast volumes are segmented from pre-contrast images using a fast semi-automated algorithm. Principal component analysis is applied to the centred intensity vectors formed from the dynamic contrast-enhanced T1-weighted images of the segmented breasts, followed by automatic thresholding to eliminate fatty tissues and slowly enhancing normal parenchyma and a convolution and filtering process to minimize artefacts from moderately enhanced normal parenchyma and blood vessels. Finally, suspicious lesions are identified through a volumetric sixfold neighbourhood connectivity search and calculation of two morphological features: volume and volumetric eccentricity, to exclude highly enhanced blood vessels, nipples and normal parenchyma and to localize lesions. This provides satisfactory lesion localization. For a detection sensitivity of 100%, the overall false-positive detection rate of the system is 1.02/lesion, 1.17/case and 0.08/slice, comparing favourably with previous studies. This approach may facilitate detection of lesions in multi-centre and multi-instrument dynamic contrast-enhanced breast MR data.

  12. Factors associated with early outcomes following standardised therapy in children with ulcerative colitis (PROTECT): a multicentre inception cohort study.

    Science.gov (United States)

    Hyams, Jeffrey S; Davis, Sonia; Mack, David R; Boyle, Brendan; Griffiths, Anne M; LeLeiko, Neal S; Sauer, Cary G; Keljo, David J; Markowitz, James; Baker, Susan S; Rosh, Joel; Baldassano, Robert N; Patel, Ashish; Pfefferkorn, Marian; Otley, Anthony; Heyman, Melvin; Noe, Joshua; Oliva-Hemker, Maria; Rufo, Paul; Strople, Jennifer; Ziring, David; Guthery, Stephen L; Sudel, Boris; Benkov, Keith; Wali, Prateek; Moulton, Dedrick; Evans, Jonathan; Kappelman, Michael D; Marquis, Alison; Sylvester, Francisco A; Collins, Margaret H; Venkateswaran, Suresh; Dubinsky, Marla; Tangpricha, Vin; Spada, Krista L; Britt, Ashley; Saul, Bradley; Gotman, Nathan; Wang, Jessie; Serrano, Jose; Kugathasan, Subra; Walters, Thomas; Denson, Lee A

    2017-12-01

    Previous retrospective studies of paediatric ulcerative colitis have had limited ability to describe disease progression and identify predictors of treatment response. In this study, we aimed to identify characteristics associated with outcomes following standardised therapy after initial diagnosis. The PROTECT multicentre inception cohort study was based at 29 centres in the USA and Canada and included paediatric patients aged 4-17 years who were newly diagnosed with ulcerative colitis. Guided by the Pediatric Ulcerative Colitis Activity Index (PUCAI), patients received initial standardised treatment with mesalazine (PUCAI 10-30) oral corticosteroids (PUCAI 35-60), or intravenous corticosteroids (PUCAI ≥65). The key outcomes for this analysis were week 12 corticosteroid-free remission, defined as PUCAI less than 10 and taking only mesalazine, and treatment escalation during the 12 study weeks to anti-tumour necrosis factor α (TNFα) agents, immunomodulators, or colectomy among those initially treated with intravenous corticosteroids. We identified independent predictors of outcome through multivariable logistic regression using a per-protocol approach. This study is registered with ClinicalTrials.gov, number NCT01536535. Patients were recruited between July 10, 2012, and April 21, 2015. 428 children initiated mesalazine (n=136), oral corticosteroids (n=144), or intravenous corticosteroids (n=148). Initial mean PUCAI was 31·1 (SD 13·3) in children initiating with mesalazine, 50·4 (13·8) in those initiating oral corticosteroids, and 66·9 (13·7) in those initiating intravenous corticosteroids (pmodel due to clinical relevance]), rectal biopsy eosinophil count less than or equal to 32 cells per high power field (4·55, 1·62-12·78; p=0·0040), rectal biopsy surface villiform changes (3·05, 1·09-8·56; p=0·034), and not achieving week 4 remission (30·28, 6·36-144·20; p<0·0001). Our findings provide guidelines to assess the response of children newly

  13. Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis

    Science.gov (United States)

    Fysh, Edward T H; Thomas, Rajesh; Read, Catherine A; Lam, Ben C H; Yap, Elaine; Horwood, Fiona C; Lee, Pyng; Piccolo, Francesco; Shrestha, Ranjan; Garske, Luke A; Lam, David C L; Rosenstengel, Andrew; Bint, Michael; Murray, Kevin; Smith, Nicola A; Lee, Y C Gary

    2014-01-01

    Introduction Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients’ remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources. Methods and analysis The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The

  14. Knowledge and Awareness among Parents and General Dental Practitioners regarding Rehabilitation with Full Coverage Restoration in Children: A Multi-centric Trial.

    Science.gov (United States)

    Moda, Aman; Saroj, Gyanendra; Sharma, Swati; Gupta, Basant

    2016-01-01

    The aim of this study was to evaluate the knowledge and awareness among parents and general dental practitioners regarding rehabilitation with full coverage restoration in children following pulp therapy. A multiple choice questionnaire was given to 1,000 parents and 400 general practitioners in this multicentric trial. The questionnaire assessed their beliefs, knowledge regarding care of primary teeth, assessment of treating children, and knowledge regarding importance of primary teeth. All the questionnaires were then compiled and statistically analyzed using Statistical Package for Social Sciences (SPSS) software. 53% parents did not know the importance of primary teeth and 73% parents also thought that no treatment is possible for pulpally involved primary teeth. 20% parents believed that root canal treatment can be possible for children and only 10% knew about full coverage restorations. 40% of the general dentists felt that the best treatment in the case of primary necrotic teeth is extraction and only 13% knew about stainless steel crowns. 62% of general dental practitioners pointed out patients' noninterest in providing crowns whereas 68% parents reported non-information by dentists. Both parents and general dental practitioners have incomplete and inadequate knowledge regarding full coverage restorations, and we need to improve the knowledge and dental awareness of the parents and the general dental practitioners. How to cite this article: Moda A, Saroj G, Sharma S, Gupta B. Knowledge and Awareness among Parents and General Dental Practitioners regarding Rehabilitation with Full Coverage Restoration in Children: A Multi-centric Trial. Int J Clin Pediatr Dent 2016;9(2):177-180.

  15. Effects of SofZia-preserved travoprost and benzalkonium chloride-preserved latanoprost on the ocular surface -- a multicentre randomized single-masked study.

    Science.gov (United States)

    Aihara, Makoto; Oshima, Hiromi; Araie, Makoto

    2013-02-01

    To assess the effect of SofZia-preserved travoprost on ocular surface conditions in comparison with benzalkonium chloride (BAK)-preserved latanoprost. A prospective randomized multicentre single-masked comparative study. Patients with open-angle glaucoma or ocular hypertension who had been treated with BAK-preserved latanoprost 0.005% (Xalatan(®) ) monotherapy for at least 3 months. Patients were enrolled at 23 facilities. Patients were randomly divided into the X-X group, continuous use of Xalatan(®) , or the X-T group, switching from Xalatan(®) to SofZia-preserved travoprost 0.004% (TravatanZ(®) ), and followed for 3 months. The superficial punctate keratopathy (SPK), conjunctival epitheliopathy, hyperaemia, tear break-up time (TBUT) and intraocular pressure (IOP) were examined for each patient in a masked manner. Changes in the frequency of keratoconjunctival epitheliopathy were evaluated 3 months after study initiation. Intra- and intergroup comparisons of changes in SPK, conjunctival epitheliopathy, hyperaemia, TBUT and IOP were also carried out. Two hundred twenty patients participated and 215 completed the 3-month study. The frequency of keratoconjunctival epitheliopathy significantly decreased in the X-T group (p = 0.036) and the intergroup difference was also significant (p = 0.001). SPK scores and TBUT were significantly improved in the X-T group (p = 0.034, 0.049), also with significant intergroup differences in the cornea excluding the inferior area and TBUT. There were no significant intergroup differences in changes of the hyperaemia scores and the IOP reduction. Switching to SofZia-preserved travoprost after BAK-preserved latanoprost resulted in a lower incidence of keratoconjunctival epitheliopathy, especially in the cornea, with no clinically relevant changes in hyperaemia and IOP. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

  16. Linezolid-resistant clinical isolates of enterococci and Staphylococcus cohnii from a multicentre study in China: molecular epidemiology and resistance mechanisms.

    Science.gov (United States)

    Chen, Hongbin; Wu, Weiyuan; Ni, Ming; Liu, Yingmei; Zhang, Jixia; Xia, Fei; He, Wenqiang; Wang, Qi; Wang, Zhanwei; Cao, Bin; Wang, Hui

    2013-10-01

    Genetic characterisation of linezolid-resistant Gram-positive cocci in a multicentre study in China has not been reported previously. To study the mechanism underlying the resistance of linezolid-resistant isolates, nine Enterococcus faecalis, one Enterococcus faecium and three Staphylococcus cohnii isolates with various levels of resistance were collected from five hospitals across China in 2009-2012. The nine E. faecalis isolates were classified into seven sequence types, indicating that these linezolid-resistant E. faecalis isolates were polyclonal. Enterococci isolates had reduced susceptibility to linezolid (MICs of 4-8 mg/L) and had mutation of ribosomal protein L3, with three also having mutation of L4, but without the multidrug resistance gene cfr or the 23S rRNA mutation G2576T. The three S. cohnii isolates were highly resistant to linezolid (MICs of 64 mg/L to >256 mg/L), harboured the cfr gene and had the 23S rRNA mutation G2576T. Southern blotting indicated that the cfr gene of these three isolates resided on different plasmids (pHK01, pRM01 and pRA01). In plasmid pHK01, IS21-558 and the cfr gene were integrated into transposon Tn558. In plasmids pRM01 and pRA01, the cfr gene was flanked by two copies of an IS256-like insertion sequence, indicating that the transferable form of linezolid resistance is conferred by the cfr gene. In conclusion, the emergence of linezolid-resistant Gram-positive cocci in different regions of China is of concern. The cfr gene and the 23S rRNA mutation contribute to high-level linezolid resistance in S. cohnii, and the L3 and L4 mutations are associated with low-level linezolid resistance in enterococci. Copyright © 2013 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

  17. Moral imperialism and multi-centric clinical trials in peripheral countries.

    Science.gov (United States)

    Garrafa, Volnei; Lorenzo, Claudio

    2008-10-01

    Moral imperialism is expressed in attempts to impose moral standards from one particular culture, geopolitical region or culture onto other cultures, regions or countries. Examples of Direct Moral Imperialism can be seen in various recurrent events involving multi-centric clinical trials promoted by developed (central) countries in poor and developing (peripheral) countries, particularly projects related to the theory of double standards in research. After the WMA General Assembly refused to change the Helsinki Declaration - which would have given moral recognition to the above mentioned theory - the USA abandoned the declaration and began to promote regional seminars in peripheral countries with the aim of "training" researchers on ethical perspectives that reflect America's best interests. Individuals who received such training became transmitters of these central countries' ideas across the peripheral countries, representing a form of Indirect Moral Imperialism. The paper proposes the establishment of regulatory and social control systems for clinical trials implemented in peripheral countries, through the formulation of ethical norms that reflect the specific contexts of these countries, along with the drawing up and validation of their own national norms.

  18. Multi-centre evaluation of accuracy and reproducibility of planar and SPECT image quantification. An IAEA phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Zimmermann, Brian E. [National Institute of Standards and Technology, Gaithersburg, MD (United States); Grosev, Darko [Univ. Hospital Centre Zagreb (Croatia); Buvat, Irene [Service Hospitalier Frederic Joliot, Paris (France); and others

    2017-08-01

    Accurate quantitation of activity provides the basis for internal dosimetry of targeted radionuclide therapies. This study investigated quantitative imaging capabilities at sites with a variety of experience and equipment and assessed levels of errors in activity quantitation in Single-Photon Emission Computed Tomography (SPECT) and planar imaging. Participants from 9 countries took part in a comparison in which planar, SPECT and SPECT with X ray computed tomography (SPECT-CT) imaging were used to quantify activities of four epoxy-filled cylinders containing {sup 133}Ba, which was chosen as a surrogate for {sup 131}I. The sources, with nominal volumes of 2, 4, 6 and 23 mL, were calibrated for {sup 133}Ba activity by the National Institute of Standards and Technology, but the activity was initially unknown to the participants. Imaging was performed in a cylindrical phantom filled with water. Two trials were carried out in which the participants first estimated the activities using their local standard protocols, and then repeated the measurements using a standardized acquisition and analysis protocol. Finally, processing of the imaging data from the second trial was repeated by a single centre using a fixed protocol. In the first trial, the activities were underestimated by about 15% with planar imaging. SPECT with Chang's first order attenuation correction (Chang-AC) and SPECT-CT overestimated the activity by about 10%. The second trial showed moderate improvements in accuracy and variability. Planar imaging was subject to methodological errors, e.g., in the use of a transmission scan for attenuation correction. The use of Chang-AC was subject to variability from the definition of phantom contours. The project demonstrated the need for training and standardized protocols to achieve good levels of quantitative accuracy and precision in a multicentre setting. Absolute quantification of simple objects with no background was possible with the strictest protocol to

  19. Rationale and design of the ranolazine PH-RV study: a multicentred randomised and placebo-controlled study of ranolazine to improve RV function in patients with non-group 2 pulmonary hypertension.

    Science.gov (United States)

    Han, Yuchi; Forfia, Paul R; Vaidya, Anjali; Mazurek, Jeremy A; Park, Myung H; Ramani, Gautam; Chan, Stephen Y; Waxman, Aaron B

    2018-01-01

    A major determining factor on outcomes in patients with pulmonary arterial hypertension (PAH) is right ventricular (RV) function. Ranolazine, which is currently approved for chronic stable angina, has been shown to improve RV function in an animal model and has been shown to be safe in small human studies with PAH. We aim to study the effect of ranolazine on RV function using cardiovascular magnetic resonance (CMR) in patients with pulmonary hypertension (non-group 2 patients) and monitor the effect of ranolazine on metabolism using metabolic profiling and changes of microRNA. This study is a longitudinal, randomised, double-blind, placebo-controlled, multicentre proof-of-concept study in 24 subjects with pulmonary hypertension and RV dysfunction treated with ranolazine over 6 months. Subjects who meet the protocol definition of RV dysfunction (CMR RV ejection fraction (EF) <45%) will be randomised to ranolazine or placebo with a ratio of 2:1. Enrolled subjects will be assessed for functional class, 6 min walk test and health outcome based on SF-36 tool. Peripheral blood will be obtained for N-terminal-pro brain natriuretic peptide, metabolic profiling, and microRNA at baseline and the conclusion of the treatment period. CMR will be performed at baseline and the conclusion of the treatment period. The primary outcome is change in RVEF. The exploratory outcomes include clinical, other CMR parameters, metabolic and microRNA changes. The trial protocol was approved by Institutional Review Boards. The trial findings will be disseminated in scientific journals and meetings. NCT01839110 and NCT02829034; Pre-results.

  20. Symptom prevalence in a cohort of 65 patients improved with the homoeopathic medicine Mangifera indica: A multicentric open observational clinical verification study

    Directory of Open Access Journals (Sweden)

    Raj K Manchanda

    2017-01-01

    Full Text Available Introduction: Clinical verification is an ongoing research program of the Council that verified many rare homoeopathic drugs. Aim: To clinically verify the ‘symptomatology’ of Mangifera indica by ascertaining the symptoms improved during verification. Materials and Methods: The study was a multicentric open label observational trial. Total 114 patients were enrolled after matching with the available symptom compendium and eligibility criteria in five centres of the Council. The medicine was prescribed in 6C, 30C, 200C and 1M potencies, as per need of the patient following the homoeopathic principles and protocol developed by the Council. The collected data were presented in terms of descriptive statistics. Prevalence of symptoms in the responding and non-responding population has been compared using Chi-square test. Results: Among the total 114 patients enrolled in the study, 77 patients who completed the follow up were analysed, as there were 37 drop out cases. The demographic analysis shows, male/female: 41/36, mean age 28.61 years. There was “clinical success” in 65 cases (84.41% and failures in 12 cases (15.59%, judged subjectively by the physicians. A minimum of two prescriptions were considered for pick listing each symptom as a rule of thumb. Conclusions: Total 16 CCRH proving symptoms were verified, 4 symptoms from other literatures were also verified. 51 new clinical symptoms/symptom components were identified. Further replication and estimation of likelihood ratio in general practice setting is crucial for confirmation and inclusion of such symptoms in homoeopathic literatures.

  1. Influence of K-ras status and anti-tumour treatments on complications due to colorectal self-expandable metallic stents: a retrospective multicentre study.

    Science.gov (United States)

    Fuccio, Lorenzo; Correale, Loredana; Arezzo, Alberto; Repici, Alessandro; Manes, Gianpiero; Trovato, Cristina; Mangiavillano, Benedetto; Manno, Mauro; Cortelezzi, Claudio Camillo; Dinelli, Marco; Cennamo, Vincenzo; de Bellis, Mario

    2014-06-01

    This study aimed to explore the relationship between K-ras status, anti-tumour treatments, and the complications of colorectal self-expandable metallic stenting in colorectal cancer. This is a retrospective, multicentre study of 91 patients with obstructive advanced colorectal cancer palliated with enteral stents between 2007 and 2011. K-ras wild-type tumours were diagnosed in 44 patients (48.4%); 82 (90.1%) received chemotherapy and 45 (49.4%) had additional biological therapy (34 bevacizumab, 11 cetuximab). Twenty-one (23.1%) experienced stent-related complications: 11 (52.4%) occurred in the K-ras mutant group (P=0.9). K-ras wild-type patients were not less likely to develop adverse events than K-ras mutant patients (OR, 0.99; 95% CI: 0.4-2.7). Overall mean time to complication was 167.6 days (range 4-720 days), with no difference between the two groups (141 vs. 197 days; P=0.5). Chemotherapy did not influence the risk of complications (OR, 0.56; 95% CI: 0.14-2.9), and there was no evidence that patients treated with chemotherapy and cetuximab were more likely to experience stent-related complications than patients treated with chemotherapy alone, or untreated (OR, 1.2; 95% CI: 0.2-5.9). Although perforation rates were higher with bevacizumab-based treatment (11.8% vs. 7%), this result was not statistically significant (P=0.69). K-ras mutation status, chemotherapy, and biological treatments should not influence colorectal stent-related complication rates. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  2. Oxygen titration after resuscitation from out-of-hospital cardiac arrest: a multi-centre, randomised controlled pilot study (the EXACT pilot trial).

    Science.gov (United States)

    Bray, Janet E; Hein, Cindy; Smith, Karen; Stephenson, Michael; Grantham, Hugh; Finn, Judith; Stub, Dion; Cameron, Peter

    2018-04-20

    Recent studies suggest the administration of 100% oxygen to hyperoxic levels following return-of-spontaneous-circulation (ROSC) post-cardiac arrest may be harmful. However, the feasibility and safety of oxygen titration in the prehospital setting is unknown. We conducted a multi-centre, phase-2 study testing whether prehospital titration of oxygen results in an equivalent number of patients arriving at hospital with oxygen saturations SpO2 ≥ 94%. We enrolled unconscious adults with: sustained ROSC; initial shockable rhythm; an advanced airway; and an SpO2 ≥ 95%. Initially (Sept 2015-March 2016) patients were randomised 1:1 to either 2 litres/minute (L/min) oxygen (titrated) or >10 L/min oxygen (control) via a bag-valve reservoir. However, one site experienced a high number of desaturations (SpO2 titrated arm and this arm was changed (April 2016) to an initial reduction of oxygen to 4 L/min then, if tolerated, to 2 L/min, and the desaturation limit was decreased to titrated (n = 37: 2L/min = 20 and 2-4 L/min = 17) oxygen or control (n = 24). Patients allocated to titrated oxygen were more likely to desaturate compared to controls ((SpO2 titrated: 90% vs. control: 100%) and all patients had a SpO2 ≥ 90%. One patient (control) re-arrested. Survival to hospital discharge was similar. Oxygen titration post-ROSC is feasible in the prehospital environment, but incremental titration commencing at 4L/min oxygen flow may be needed to maintain an oxygen saturation >90% (NCT02499042). Copyright © 2018. Published by Elsevier B.V.

  3. Inhaled air quality with desk incorporated personalized ventilation (PV): parametric study

    DEFF Research Database (Denmark)

    Bolashikov, Zhecho Dimitrov; Nagano, Hideaki; Melikov, Arsen Krikor

    A workstation consisting of a desk with installed personalized ventilation (PV) and a dressed breathing thermal manikin simulating seated occupant was set in a full-scale test room. The room was conditioned by overhead ventilation at 26 oC. The PV consisted of two confluent jets incorporated along...

  4. The efficacy and safety of lixivaptan in outpatients with heart failure and volume overload: results of a multicentre, randomized, double-blind, placebo-controlled, parallel-group study.

    Science.gov (United States)

    Ghali, Jalal K; Orlandi, Cesare; Abraham, William T

    2012-06-01

    Volume overload is the dominant feature of decompensated heart failure (HF) and it often results in adverse clinical outcomes. Vasopressin receptor antagonists such as lixivaptan may provide effective volume unloading. This study assessed weight loss after 1 day and 8 weeks of treatment with lixivaptan in outpatients with HF and volume overload. This phase II, 8-week, multicentre, double-blind, parallel-group study randomized participants (2:1) to receive lixivaptan 100 mg or placebo once daily (in addition to standard HF therapy). Body weight and cardiovascular assessments were made at baseline, Day 1 (not cardiovascular), Weeks 1, 2, 4, and 8, and 7 days post-treatment. The Trail-making Test, part B (TMT-B) and the Medical Outcomes Survey 6-item cognitive function scale (MOS-6) were assessed at baseline and Week 4. The study randomized 170 participants (lixivaptan, n = 111; placebo, n = 59). Most (97.1%) were receiving pharmacological therapy for HF at baseline. Demographic characteristics were generally similar between the two groups. Body weight decreased significantly from baseline to Day 1 with lixivaptan vs. placebo (least-square mean change ± standard error: - 0.38 ± 0.08 kg vs. +0.13 ± 0.11 kg; P overload, lixivaptan 100 mg once daily, when added to standard therapy, reduced body weight, improved dyspnoea and orthopnoea, and was well tolerated. NCT01055912.

  5. Experiments on the Microenvironment and Breathing of a Person in Isothermal and Stratified Surroundings

    DEFF Research Database (Denmark)

    Nielsen, Peter V.; Jensen, Rasmus Lund; Litewnicki, Michal

    2009-01-01

    This study investigates the characteristics of human exhalation. Experiments are performed on a breathing thermal manikin in a test room. The manikin is heated, and an artificial lung is used to generate varying air flows with specific flow rates and temperatures for breathing. Smoke visualisation...... is used to show the formation, movement and disappearance of the exhalation jets from both nose and mouth. The exhalation of breathing without ventilation in the room, and with stratified surroundings (displacement ventilation) is analysed....

  6. MRI of the wrist in juvenile idiopathic arthritis: proposal of a paediatric synovitis score by a consensus of an international working group. Results of a multicentre reliability study

    International Nuclear Information System (INIS)

    Damasio, Maria Beatrice; Mattiuz, Chiara; Magnano, GianMichele; Malattia, Clara; Martini, Alberto; Tanturri de Horatio, Laura; Barbuti, Domenico; Toma, Paolo; Pistorio, Angela; Bracaglia, Claudia; Boavida, Peter; Ording, Lil Sophie Mueller; Juhan, Karen Lambot; Rosendahl, Karen

    2012-01-01

    MRI is a sensitive tool for the evaluation of synovitis in juvenile idiopathic arthritis (JIA). The purpose of this study was to introduce a novel MRI-based score for synovitis in children and to examine its inter- and intraobserver variability in a multi-centre study. Wrist MRI was performed in 76 children with JIA. On postcontrast 3-D spoiled gradient-echo and fat-suppressed T2-weighted spin-echo images, joint recesses were scored for the degree of synovial enhancement, effusion and overall inflammation independently by two paediatric radiologists. Total-enhancement and inflammation-synovitis scores were calculated. Interobserver agreement was poor to moderate for enhancement and inflammation in all recesses, except in the radioulnar and radiocarpal joints. Intraobserver agreement was good to excellent. For enhancement and inflammation scores, mean differences (95 % CI) between observers were -1.18 (-4.79 to 2.42) and -2.11 (-6.06 to 1.83). Intraobserver variability (reader 1) was 0 (-1.65 to 1.65) and 0.02 (-1.39 to 1.44). Intraobserver agreement was good. Except for the radioulnar and radiocarpal joints, interobserver agreement was not acceptable. Therefore, the proposed scoring system requires further refinement. (orig.)

  7. MRI of the wrist in juvenile idiopathic arthritis: proposal of a paediatric synovitis score by a consensus of an international working group. Results of a multicentre reliability study.

    Science.gov (United States)

    Damasio, Maria Beatrice; Malattia, Clara; Tanturri de Horatio, Laura; Mattiuz, Chiara; Pistorio, Angela; Bracaglia, Claudia; Barbuti, Domenico; Boavida, Peter; Juhan, Karen Lambot; Ording, Lil Sophie Mueller; Rosendahl, Karen; Martini, Alberto; Magnano, GianMichele; Tomà, Paolo

    2012-09-01

    MRI is a sensitive tool for the evaluation of synovitis in juvenile idiopathic arthritis (JIA). The purpose of this study was to introduce a novel MRI-based score for synovitis in children and to examine its inter- and intraobserver variability in a multi-centre study. Wrist MRI was performed in 76 children with JIA. On postcontrast 3-D spoiled gradient-echo and fat-suppressed T2-weighted spin-echo images, joint recesses were scored for the degree of synovial enhancement, effusion and overall inflammation independently by two paediatric radiologists. Total-enhancement and inflammation-synovitis scores were calculated. Interobserver agreement was poor to moderate for enhancement and inflammation in all recesses, except in the radioulnar and radiocarpal joints. Intraobserver agreement was good to excellent. For enhancement and inflammation scores, mean differences (95 % CI) between observers were -1.18 (-4.79 to 2.42) and -2.11 (-6.06 to 1.83). Intraobserver variability (reader 1) was 0 (-1.65 to 1.65) and 0.02 (-1.39 to 1.44). Intraobserver agreement was good. Except for the radioulnar and radiocarpal joints, interobserver agreement was not acceptable. Therefore, the proposed scoring system requires further refinement.

  8. MRI of the wrist in juvenile idiopathic arthritis: proposal of a paediatric synovitis score by a consensus of an international working group. Results of a multicentre reliability study

    Energy Technology Data Exchange (ETDEWEB)

    Damasio, Maria Beatrice; Mattiuz, Chiara; Magnano, GianMichele [Ospedale Pediatrico Gaslini, Department of Radiology, Genova (Italy); Malattia, Clara; Martini, Alberto [University of Genova, Department of Paediatrics, Genova (Italy); Tanturri de Horatio, Laura; Barbuti, Domenico; Toma, Paolo [Ospedale Pediatrico Bambino Gesu, Department of Radiology, Rome (Italy); Pistorio, Angela [Ospedale pediatrico Gaslini, Department of Epidemiology and Biostatistics, Genova (Italy); Bracaglia, Claudia [Ospedale Pediatrico Bambino Gesu, Department of Rheumatology, Rome (Italy); Boavida, Peter; Ording, Lil Sophie Mueller [Great Ormond Street Hospital for Children, Department of Radiology, London (United Kingdom); Juhan, Karen Lambot [Hopital Necker Enfants Malades, Department of Radiology, Paris (France); Rosendahl, Karen [University Hospital North Norway, Department of Radiology, Tromsoe (Norway)

    2012-09-15

    MRI is a sensitive tool for the evaluation of synovitis in juvenile idiopathic arthritis (JIA). The purpose of this study was to introduce a novel MRI-based score for synovitis in children and to examine its inter- and intraobserver variability in a multi-centre study. Wrist MRI was performed in 76 children with JIA. On postcontrast 3-D spoiled gradient-echo and fat-suppressed T2-weighted spin-echo images, joint recesses were scored for the degree of synovial enhancement, effusion and overall inflammation independently by two paediatric radiologists. Total-enhancement and inflammation-synovitis scores were calculated. Interobserver agreement was poor to moderate for enhancement and inflammation in all recesses, except in the radioulnar and radiocarpal joints. Intraobserver agreement was good to excellent. For enhancement and inflammation scores, mean differences (95 % CI) between observers were -1.18 (-4.79 to 2.42) and -2.11 (-6.06 to 1.83). Intraobserver variability (reader 1) was 0 (-1.65 to 1.65) and 0.02 (-1.39 to 1.44). Intraobserver agreement was good. Except for the radioulnar and radiocarpal joints, interobserver agreement was not acceptable. Therefore, the proposed scoring system requires further refinement. (orig.)

  9. Experimental and numerical study of back-cooling car-seat system using embedded heat pipes to improve passenger’s comfort

    International Nuclear Information System (INIS)

    Hatoum, Omar; Ghaddar, Nesreen; Ghali, Kamel; Ismail, Nagham

    2017-01-01

    Graphical abstract: Heat pipe assembly (a) with the insulation layer (b) without the insulation layer; and (c) thermal manikin test on the heat pipe chair. - Highlights: • A new back cooling system for a car seat using embedded heat pipes was modeled numerically. • The heat-pipe seat model was experimentally validated using heated thermal manikin. • An integrated heat pipe model and bio-heat model was used to predict local thermal comfort. • The heat pipe system reduced the back skin temperature by 1 °C compared to seat without heat pipes. • The heat pipe system increased the overall thermal comfort of the passenger by 30%. - Abstract: This work develops a back-cooling system for a car seat using seat embedded heat pipes to improve passenger comfort. The heat pipe system utilizes the temperature difference between the passenger back and the car cabin air to remove heat from the human body and enhance the comfort state. The developed seat heat-pipe model was validated experimentally using a thermal manikin with controlled constant skin temperature mode in a climatic chamber. Good agreement was found between the measured and the numerically predicted values of base panel temperature. By integrating the validated heat pipe with a bio-heat model, the back segmental skin temperature as well as the overall thermal comfort was predicted and compared with the conventional seat case without the heat pipe system. The heat pipes were able to reduce the skin temperature by 1 °C and to increase the overall thermal comfort of the body by 30%. In addition, a parametric study was performed to determine the optimal number of heat pipes that ensure the thermal comfort of the passenger.

  10. Automatic segmentation of male pelvic anatomy on computed tomography images: a comparison with multiple observers in the context of a multicentre clinical trial.

    Science.gov (United States)

    Geraghty, John P; Grogan, Garry; Ebert, Martin A

    2013-04-30

    This study investigates the variation in segmentation of several pelvic anatomical structures on computed tomography (CT) between multiple observers and a commercial automatic segmentation method, in the context of quality assurance and evaluation during a multicentre clinical trial. CT scans of two prostate cancer patients ('benchmarking cases'), one high risk (HR) and one intermediate risk (IR), were sent to multiple radiotherapy centres for segmentation of prostate, rectum and bladder structures according to the TROG 03.04 "RADAR" trial protocol definitions. The same structures were automatically segmented using iPlan software for the same two patients, allowing structures defined by automatic segmentation to be quantitatively compared with those defined by multiple observers. A sample of twenty trial patient datasets were also used to automatically generate anatomical structures for quantitative comparison with structures defined by individual observers for the same datasets. There was considerable agreement amongst all observers and automatic segmentation of the benchmarking cases for bladder (mean spatial variations segmenting a prostate with considerably more volume (mean +113.3%) than that automatically segmented. Similar results were seen across the twenty sample datasets, with disagreement between iPlan and observers dominant at the prostatic apex and superior part of the rectum, which is consistent with observations made during quality assurance reviews during the trial. This study has demonstrated quantitative analysis for comparison of multi-observer segmentation studies. For automatic segmentation algorithms based on image-registration as in iPlan, it is apparent that agreement between observer and automatic segmentation will be a function of patient-specific image characteristics, particularly for anatomy with poor contrast definition. For this reason, it is suggested that automatic registration based on transformation of a single reference dataset

  11. Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model.

    Science.gov (United States)

    Koniotou, Marina; Evans, Bridie Angela; Chatters, Robin; Fothergill, Rachael; Garnsworthy, Christopher; Gaze, Sarah; Halter, Mary; Mason, Suzanne; Peconi, Julie; Porter, Alison; Siriwardena, A Niroshan; Toghill, Alun; Snooks, Helen

    2015-07-10

    Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial. In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model. We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed. Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial. Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009.

  12. Treatment of Advanced Glaucoma Study: a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma-study protocol.

    Science.gov (United States)

    King, Anthony J; Fernie, Gordon; Azuara-Blanco, Augusto; Burr, Jennifer M; Garway-Heath, Ted; Sparrow, John M; Vale, Luke; Hudson, Jemma; MacLennan, Graeme; McDonald, Alison; Barton, Keith; Norrie, John

    2017-10-26

    Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients. To compare clinical and cost-effectiveness of primary medical management compared with primary surgery for people presenting with advanced open-angle glaucoma (OAG). Design : A prospective, pragmatic multicentre randomised controlled trial (RCT). Twenty-seven UK hospital eye services. Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss. Participants will be randomised to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes). The primary outcome is vision-related quality of life measured by the National Eye Institute-Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per quality-adjusted life-year (QALY) based on EQ-5D-5L and glaucoma profile instrument will be estimated. The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years. Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma. ISRCTN56878850, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial

  13. Help-seeking and antibiotic prescribing for acute cough in a Chinese primary care population: a prospective multicentre observational study.

    Science.gov (United States)

    Wong, Carmen Ka Man; Liu, Zhaomin; Butler, Chris C; Wong, Samuel Yeung Shan; Fung, Alice; Chan, Dicken; Yip, Benjamin Hon Kei; Kung, Kenny

    2016-01-21

    Acute cough is a common reason to prescribe antibiotics in primary care. This study aimed to explore help-seeking and antibiotic prescribing for acute cough in Chinese primary care population. This is a prospective multicentre observational study that included adults presenting with acute cough. Clinicians recorded patients' presenting symptoms, examination findings and medication prescription. Patients completed symptom diaries for up to 28 days by charting their symptom severity and recovery. Adjusted binary logistic regression models identified factors independently associated with antibiotic prescription. Primary care clinicians (n=19) recruited 455 patients. A total of 321 patients (70.5%) returned their completed symptom diaries. Concern about illness severity (41.6%) and obtaining a prescription for symptomatic medications (45.9%), rather than obtaining a prescription for antibiotics, were the main reasons for consulting. Antibiotics were prescribed for 6.8% (n=31) of patients, of which amoxicillin was the most common antimicrobial prescribed (61.3%), as it was associated with clinicians' perception of benefit from antibiotic treatment (odds ratio (OR): 25.9, 95% confidence interval (CI): 6.7-101.1), patients' expectation for antibiotics (OR: 5.1, 95% CI: 1.7-11.6), anticipation (OR: 5.1, 95% CI: 1.6-15.0) and request for antibiotics (OR 15.7, 95% CI: 5.0-49.4), as well as the severity of respiratory symptoms (cough, sputum, short of breath and wheeze OR: 2.7-3.7, all Pantibiotic prescription rates between private primary care clinicians and public primary care clinicians (17.4 vs 1.6%, P=0.00). Symptomatic medication was prescribed in 98.0% of patients. Mean recovery was 9 days for cough and 10 days for all symptoms, which was not significantly associated with antibiotic treatment. Although overall antibiotic-prescribing rates were low, there was a higher rate of antibiotic prescribing among private primary care clinicians, which warrants further

  14. Is lesional stability in vitiligo more important than disease stability for performing surgical interventions? results from a multicentric study

    Directory of Open Access Journals (Sweden)

    Imran Majid

    2016-01-01

    Full Text Available Background: Ensuring stability of the disease process is essential for undertaking surgical intervention in vitiligo. However, there is no consensus regarding the minimum duration of stability or the relative importance of disease and lesional stability in selecting patients for vitiligo grafting. Aim: This multicentric study aims to assess the relative importance of lesional and disease stability on selecting patients for vitiligo grafting. Materials and Methods: One hundred seventy patients were recruited into the study and divided into two groups: Group A with lesional stability of >1 year but overall disease stability of only 6-11 months and Group B with overall disease stability of >1 year. Patients underwent either tissue or cellular vitiligo grafting on the selected lesions and the repigmentation achieved was scored from 0 (no repigmentation to 6 (100% repigmentation. Repigmentation achieved on different sites of the body was compared between the two groups. Adverse effects at both the donor and the recipient sites were also compared. Results: Of the 170 patients who were enrolled, 82 patients were placed in Group A and 88 patients in Group B. Average repigmentation achieved (on scale of 0 to 6 was 3.8 and 4.04 in Group A and Group B, respectively. In Group A, ≥90% repigmentation was achieved in 36.6% (30/82 patients, while 37.5% (33/88 achieved similar results in Group B. Additionally, 47.6% (39/82 and 53.4% (47/88 of cases achieved partial repigmentation in Group A and Group B, respectively. Perigraft halo was the commonest adverse effect observed in both groups. Statistical analysis revealed no significant differences between the two groups with respect to the repigmentation achieved or adverse effects observed. Repigmentation achieved was the best on the face and neck area, while acral areas responded the least. Conclusions: Lesional stability seems to be as relevant as the overall disease stability in selecting patients for

  15. Multicentric Castleman's Disease in a Hepatitis C-Positive Intravenous Drug User: A Case Report

    Directory of Open Access Journals (Sweden)

    D. Y. Talukder

    2011-01-01

    Full Text Available Introduction. We report a rare presentation of Castleman's disease in a hepatitis C-positive patient and present a short review of treatments described in other similar case reports and studies. Case Presentation. A 46-year-old male with untreated hepatitis C and a 16-year history of intravenous drug use presented with pleuritic chest pain and bony pain in the knee, hip, and lower back, on a background of unexplained weight loss of 40 kilograms, fevers, night sweats, and repeated infections over the last two years. Examination discovered tender hepatomegaly, a warm right knee effusion, and painless lymphadenopathy. The patient was reactive to Epstein Barr virus and cytomegalovirus; however, HIV and HHV-8 viral testing was negative. Osteomyelitis of vertebrae T8–T11 and septic arthritis of the knee were found on investigation. A lymph node biopsy revealed histology suggestive of plasmacytic Castleman's disease. The patient is to commence rituximab treatment. Conclusion. Castleman's disease continues to present in novel ways, which may lead to difficulties in clinicopathologic diagnosis. A growing body of evidence suggests larger studies are required to determine the best treatment for multicentric Castleman's disease, particularly in patients with a concomitant disease, including hepatitis C.

  16. Comparison of basic life support (BLS video self-instructional system and traditional BLS training in first year nursing students

    Directory of Open Access Journals (Sweden)

    R Nikandish

    2009-03-01

    Full Text Available Background: For several years, educators have criticized the lecture-based  approach  to teaching and learning. Experts have rightly stressed on acquisition  of a number of critical  skills rather than focusing on lectures. Purpose. To compare students'  pe1jormance after self-education  with VCD and manikin,  with thei performance after standard BLS training.Methods: In this randomized controlled study, twenty first-year nursing students were divided into two groups randomly, and were provided with basic life support (BLS instruction either in the traditional format of lecturing or with VCD and manikin without tutor. The students’ Performance was evaluated on a manikin with a checklist including all steps in BLS.Results: With traditional  instruction,  students'  mean score was 42.2±3.91, while it was 46.3±3.86 with self-education,  showing no significant  difference.Conclusion: In nursing students with no previous BLS training, access to VCD and manikin facilitates immediate achievement of educational objectives similar to those  of a standard  BLS course.  Self­ learning BLS with VCD should be enhanced with a short period of hands-on practice.Keywords: cardiopulmonary resuscitation (CPR, nursing students, cpr skills, education

  17. Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol

    Science.gov (United States)

    Dias, Katrin A; Coombes, Jeff S; Green, Daniel J; Gomersall, Sjaan R; Keating, Shelley E; Tjonna, Arnt Erik; Hollekim-Strand, Siri Marte; Hosseini, Mansoureh Sadat; Ro, Torstein Baade; Haram, Margrete; Huuse, Else Marie; Davies, Peter S W; Cain, Peter A; Leong, Gary M; Ingul, Charlotte B

    2016-01-01

    Introduction The prevalence of paediatric obesity is increasing, and with it, lifestyle-related diseases in children and adolescents. High-intensity interval training (HIIT) has recently been explored as an alternate to traditional moderate-intensity continuous training (MICT) in adults with chronic disease and has been shown to induce a rapid reversal of subclinical disease markers in obese children and adolescents. The primary aim of this study is to compare the effects of HIIT with MICT on myocardial function in obese children and adolescents. Methods and analysis Multicentre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). The trial will examine the efficacy of HIIT to improve cardiometabolic outcomes in obese children and adolescents. Participants will be randomised to (1) HIIT and nutrition advice, (2) MICT and nutrition advice or (3) nutrition advice. Participants will partake in supervised exercise training and/or nutrition sessions for 3 months. Measurements for study end points will occur at baseline, 3 months (postintervention) and 12 months (follow-up). The primary end point is myocardial function (peak systolic tissue velocity). Secondary end points include vascular function (flow-mediated dilation assessment), quantity of visceral and subcutaneous adipose tissue, myocardial structure and function, body composition, cardiorespiratory fitness, autonomic function, blood biochemistry, physical activity and nutrition. Lean, healthy children and adolescents will complete measurements for all study end points at one time point for comparative cross-sectional analyses. Ethics and dissemination This randomised controlled trial will generate substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardiometabolic health of this at-risk population. It is expected that communication of results will allow for the development of

  18. What is the optimal salvage procedure for cut-out after surgical fixation of trochanteric fractures with the PFNA or TFN?: A multicentre study.

    Science.gov (United States)

    Brunner, Alexander; Büttler, Markus; Lehmann, Uwe; Frei, Hans Curd; Kratter, Renato; Di Lazzaro, Marco; Scola, Alexander; Sermon, An; Attal, Rene

    2016-02-01

    To evaluate the outcome after different types of revision operations for blade 'cut-out' and 'cut-through' after fixation of trochanteric fractures with proximal femoral nail antirotation (PFNA) or a trochanter fixation nail (TFN). Twenty hospitals participated in this multicentre study. A total of 4109 patients were retrospectively screened for cut-out or cut-through complications after nailing of trochanteric fractures using PFNA or TFN. Fifty-seven patients (28 with 'cut-through' and 29 with 'cut-out') were included in the study. In the 'cut-through' group, 16 patients underwent a blade exchange, six patients had a blade exchange with bone cement augmentation, and six received total hip arthroplasty (THA). In the 'cut-out' group, three patients had a blade exchange, one had a blade exchange with augmentation, three underwent re-nailing of the fracture with a new PFNA, one had a girdlestone procedure and 21 had THA procedures. In the 'cut-through' group, eight patients who had a blade exchanges (50%) and two patients with blade exchange and augmentation (33%) required further revision operations. THA was the definite treatment in all 6 cases. In the 'cut-out' group, two patients (66%) who had blade exchanges and two (66%) who underwent re-nailing required additional revision operations during the subsequent course. One patient (4%) who had total hip arthroplasty needed revision surgery for acetabular replacement. Overall, a total of 81 revision procedures were performed. Based on the data from this study, we recommend THA as the only valid salvage procedure for 'cut-out' and 'cut-through' of helical blades after fixation of trochanteric fractures with the PFNA and TFN. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Absence of detectable influenza RNA transmitted via aerosol during various human respiratory activities--experiments from Singapore and Hong Kong.

    Directory of Open Access Journals (Sweden)

    Julian W Tang

    Full Text Available Two independent studies by two separate research teams (from Hong Kong and Singapore failed to detect any influenza RNA landing on, or inhaled by, a life-like, human manikin target, after exposure to naturally influenza-infected volunteers. For the Hong Kong experiments, 9 influenza-infected volunteers were recruited to breathe, talk/count and cough, from 0.1 m and 0.5 m distance, onto a mouth-breathing manikin. Aerosolised droplets exhaled from the volunteers and entering the manikin's mouth were collected with PTFE filters and an aerosol sampler, in separate experiments. Virus detection was performed using an in-house influenza RNA reverse-transcription polymerase chain reaction (RT-PCR assay. No influenza RNA was detected from any of the PTFE filters or air samples. For the Singapore experiments, 6 influenza-infected volunteers were asked to breathe (nasal/mouth breathing, talk (counting in English/second language, cough (from 1 m/0.1 m away and laugh, onto a thermal, breathing manikin. The manikin's face was swabbed at specific points (around both eyes, the nostrils and the mouth before and after exposure to each of these respiratory activities, and was cleaned between each activity with medical grade alcohol swabs. Shadowgraph imaging was used to record the generation of these respiratory aerosols from the infected volunteers and their impact onto the target manikin. No influenza RNA was detected from any of these swabs with either team's in-house diagnostic influenza assays. All the influenza-infected volunteers had diagnostic swabs taken at recruitment that confirmed influenza (A/H1, A/H3 or B infection with high viral loads, ranging from 10(5-10(8 copies/mL (Hong Kong volunteers/assay and 10(4-10(7 copies/mL influenza viral RNA (Singapore volunteers/assay. These findings suggest that influenza RNA may not be readily transmitted from naturally-infected human source to susceptible recipients via these natural respiratory activities, within

  20. Seat headrest-incorporated personalized ventilation: Thermal comfort and inhaled air quality

    DEFF Research Database (Denmark)

    Melikov, Arsen Krikor; Ivanova, T.; Stefanova, G.

    2012-01-01

    inhaled by the manikin was measured and used to assess the clean air supply efficiency of the SHPV. The response of 35 subjects was collected to examine thermal comfort with the SHPV. The subjects participated in 3 experiments at personalized air temperature and room air temperature of 22/20 °C, 23/23 °C......The performance of personalized ventilation with seat headrest-mounted air supply terminal devices (ATD), named seat headrest personalized ventilation (SHPV), was studied. Physical measurements using a breathing thermal manikin were taken to identify its ability to provide clean air to inhalation...... depending on design, shape, size and positioning of the ATD, flow rate and temperature of personalized air, room temperature, clothing thermal insulation of the manikin, etc. Tracer gas was mixed with the room air. The air supplied by the SHPV was free of tracer gas. Tracer gas concentration in the air...

  1. Short-range airborne transmission of expiratory droplets between two people

    DEFF Research Database (Denmark)

    Liu, Li; Li, Yuguo; Nielsen, Peter Vilhelm

    2017-01-01

    , ventilation, and breathing mode. Under the specific set of conditions studied, we found a substantial increase in airborne exposure to droplet nuclei exhaled by the source manikin when a susceptible manikin is within about 1.5 m of the source manikin, referred to as the proximity effect. The threshold...... distance of about 1.5 m distinguishes the two basic transmission processes of droplets and droplet nuclei, that is, short-range modes and the long-range airborne route. The short-range modes include both the conventional large droplet route and the newly defined short-range airborne transmission. We thus...... reveal that transmission occurring in close proximity to the source patient includes both droplet-borne (large droplet) and short-range airborne routes, in addition to the direct deposition of large droplets on other body surfaces. The mechanisms of the droplet-borne and short-range airborne routes...

  2. The relationship between effectiveness and costs measured by a risk-adjusted case-mix system: multicentre study of Catalonian population data bases

    Directory of Open Access Journals (Sweden)

    Flor-Serra Ferran

    2009-06-01

    Full Text Available Abstract Background The main objective of this study is to measure the relationship between morbidity, direct health care costs and the degree of clinical effectiveness (resolution of health centres and health professionals by the retrospective application of Adjusted Clinical Groups in a Spanish population setting. The secondary objectives are to determine the factors determining inadequate correlations and the opinion of health professionals on these instruments. Methods/Design We will carry out a multi-centre, retrospective study using patient records from 15 primary health care centres and population data bases. The main measurements will be: general variables (age and sex, centre, service [family medicine, paediatrics], and medical unit, dependent variables (mean number of visits, episodes and direct costs, co-morbidity (Johns Hopkins University Adjusted Clinical Groups Case-Mix System and effectiveness. The totality of centres/patients will be considered as the standard for comparison. The efficiency index for visits, tests (laboratory, radiology, others, referrals, pharmaceutical prescriptions and total will be calculated as the ratio: observed variables/variables expected by indirect standardization. The model of cost/patient/year will differentiate fixed/semi-fixed (visits costs of the variables for each patient attended/year (N = 350,000 inhabitants. The mean relative weights of the cost of care will be obtained. The effectiveness will be measured using a set of 50 indicators of process, efficiency and/or health results, and an adjusted synthetic index will be constructed (method: percentile 50. The correlation between the efficiency (relative-weights and synthetic (by centre and physician indices will be established using the coefficient of determination. The opinion/degree of acceptance of physicians (N = 1,000 will be measured using a structured questionnaire including various dimensions. Statistical analysis: multiple regression

  3. Effects of surgery on ischaemic mitral regurgitation: a prospective multicentre registry (SIMRAM registry)

    DEFF Research Database (Denmark)

    Lancellotti, P.; Donal, E.; Cosyns, B.

    2008-01-01

    at rest. Exercise echocardiography may help identify a subset of patients at higher risk of cardiovascular events by revealing the dynamic component of IMR. METHODS: A large prospective, multicentre, non-randomized registry is designed to evaluate the effects of surgery on IMR at rest and on its dynamic......AIMS: Functional ischaemic mitral regurgitation (IMR) is common in patients with ischaemic left ventricular dysfunction undergoing coronary artery bypass surgery. Although the presence of IMR negatively affects prognosis, the additional benefit of valve repair is debated, particularly with mild IMR...... component at exercise (z). SIMRAM will enrol approximately 550 patients with IMR in up to 17 centres with clinical and exercise follow-up for 1 year. Three sets of outcomes will be prospectively assessed and several hypotheses will be tested including determinants of adverse outcome and progressive left...

  4. Thermal environment in simulated offices with convective and radiant cooling systems under cooling (summer) mode of operation

    DEFF Research Database (Denmark)

    Mustakallio, Panu; Bolashikov, Zhecho Dimitrov; Kostov, Kalin

    2016-01-01

    The thermal environment in a double office room and in a six-person meeting room obtained with chilled beam (CB), chilled beam with radiant panel (CBR), chilled ceiling with ceiling installed mixing ventilation (CCMV) and four desk partition-mounted local radiant cooling panels with mixing...... calculated. Manikin-based equivalent temperature (MBET) was determined by using two thermal manikins to identify the impact of the local thermal conditions generated by the studied systems on occupants' thermal perception. The results revealed that the differences in the thermal conditions achieved...

  5. Prevalence of adherence to treatment in homebound elderly people in primary health care: a descriptive, cross-sectional, multicentre study.

    Science.gov (United States)

    Cárdenas-Valladolid, Juan; Martín-Madrazo, Carmen; Salinero-Fort, Miguel A; Carrillo de-Santa Pau, Enrique; Abánades-Herranz, Juan C; de Burgos-Lunar, Carmen

    2010-08-01

    Adherence to the therapeutic plan is one of the most important health issues in terms of treatment efficacy, healthcare costs and patient safety. Unfortunately, homebound elderly patients are especially vulnerable to nonadherence because they have higher morbidity rates combined with cognitive and social problems that hinder their correct use of drugs. The level of therapeutic adherence in homebound elderly people has not been adequately studied. To estimate the prevalence of therapeutic adherence, using the Morisky-Green test, in homebound elderly patients taking polypharmacy (defined as use of four or more drugs), and to study the factors associated with adherence. This was a descriptive, cross-sectional, multicentre study. A total of 327 patients were selected by random start systematic sampling from the total number of homebound patients taking four or more drugs in Healthcare Area 4 of the Madrid Autonomous Region, Spain. Through an in-home survey of patients and their caregivers, information was gathered on sociodemographic data, co-morbidities, number of hospital admissions, responsibility for purchasing and preparation of the medication, level of cognitive impairment (Pfeiffer questionnaire), functional dependence in activities of daily living (Katz Index), knowledge of the disease (Batalla test), adherence to treatment (Morisky-Green test), visual and auditory perception, and caregiver burden (Zarit interview). Of the homebound patients, 65.7% (95% CI 60.6, 70.9) had good adherence to treatment. The variables most negatively associated with therapeutic adherence, after adjustment for age, sex, number of drugs, knowledge of the disease, and cognitive function, were a large caregiver burden (odds ratio [OR] 3.09; 95% CI 1.75, 5.48) and impaired hearing (OR 2.00; 95% CI 1.17, 3.40). There was also a trend toward a positive association between nonadherence and patients aged <85 years (OR 1.57; 95% CI 0.93, 2.65) and patients who had nine or more drug

  6. PIMS (Positioning In Macular hole Surgery) trial - a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Pasu, Saruban; Bunce, Catey; Hooper, Richard; Thomson, Ann; Bainbridge, James

    2015-11-17

    Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 μm) macular holes, and thereby reduces the need for further surgery. This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 μm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 μm) full-thickness macular holes following surgery. This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. UK CRN: 17966 (date of registration 26 November 2014).

  7. Rococo study: a real-world evaluation of an over-the-counter medicine in acute cough (a multicentre, randomised, controlled study).

    Science.gov (United States)

    Birring, S S; Brew, J; Kilbourn, A; Edwards, V; Wilson, R; Morice, A H

    2017-01-16

    To investigate the efficacy and safety of CS1002, an over-the-counter cough treatment containing diphenhydramine, ammonium chloride and levomenthol in a cocoa-based demulcent. A multicentre, randomised, parallel group, controlled, single-blinded study in participants with acute upper respiratory tract infection-associated cough. 4 general practitioner (GP) surgeries and 14 pharmacies in the UK. Participants aged ≥18 years who self-referred to a GP or pharmacist with acute cough of <7 days' duration. Participant inclusion criterion was cough severity ≥60 mm on a 0-100 mm visual analogue scale (VAS). Exclusion criteria included current smokers or history of smoking within the past 12 months (including e-cigarettes). 163 participants were randomised to the study (mean participant age 38 years, 57% females). Participants were randomised to CS1002 (Unicough) or simple linctus (SL), a widely used cough treatment, and treatment duration was 7 days or until resolution of cough. The primary analysis was intention-to-treat (157 participants) and comprised cough severity assessed using a VAS after 3 days' treatment (prespecified primary end point at day 4). Cough frequency, sleep disruption, health status (Leicester Cough Questionnaire (LCQ-acute)) and cough resolution were also assessed. At day 4 (primary end point), the adjusted mean difference (95% CI) in cough severity VAS between CS1002 and SL was -5.9 mm (-14.4 to 2.7), p=0.18. At the end of the study (day 7) the mean difference in cough severity VAS was -4.2 mm (-12.2 to 3.9), p=0.31. CS1002 was associated with a greater reduction in cough sleep disruption (mean difference -11.6 mm (-20.6 to 2.7), p=0.01) and cough frequency (mean difference -8.1 mm (-16.2 to 0.1), p=0.05) compared with SL. There was greater improvement in LCQ-acute quality of life scores with CS1002 compared with SL: mean difference (95% CI) 1.2 (0.05 to 2.36), p=0.04 after 5 days' treatment. More participants prematurely

  8. Outcome of adults with Eisenmenger syndrome treated with drugs specific to pulmonary arterial hypertension: A French multicentre study.

    Science.gov (United States)

    Hascoet, Sebastien; Fournier, Emmanuelle; Jaïs, Xavier; Le Gloan, Lauriane; Dauphin, Claire; Houeijeh, Ali; Godart, Francois; Iriart, Xavier; Richard, Adelaïde; Radojevic, Jelena; Amedro, Pascal; Bosser, Gilles; Souletie, Nathalie; Bernard, Yvette; Moceri, Pamela; Bouvaist, Hélène; Mauran, Pierre; Barre, Elise; Basquin, Adeline; Karsenty, Clement; Bonnet, Damien; Iserin, Laurence; Sitbon, Olivier; Petit, Jérôme; Fadel, Elie; Humbert, Marc; Ladouceur, Magalie

    2017-05-01

    The relationship between pulmonary arterial hypertension-specific drug therapy (PAH-SDT) and mortality in Eisenmenger syndrome (ES) is controversial. To investigate outcomes in patients with ES, and their relationship with PAH-SDT. Retrospective, observational, nationwide, multicentre cohort study. We included 340 patients with ES: genetic syndrome (n=119; 35.3%); pretricuspid defect (n=75; 22.1%). Overall, 276 (81.2%) patients received PAH-SDT: monotherapy (endothelin receptor antagonist [ERA] or phosphodiesterase 5 inhibitor [PDE5I]) 46.7%; dual therapy (ERA+PDE5I) 40.9%; triple therapy (ERA+PDE5I+prostanoid) 9.1%. Median PAH-SDT duration was 5.5 years [3.0-9.1 years]. Events (death, lung or heart-lung transplantation) occurred in 95 (27.9%) patients at a median age of 40.5 years [29.4-47.6]. The cumulative occurrence of events was 16.7% [95% confidence interval 12.8-21.6%] and 46.4% [95% confidence interval 38.2-55.4%] at age 40 and 60 years, respectively. With age at evaluation or time since PAH diagnosis as time scales, cumulative occurrence of events was lower in patients taking one or two PAH-SDTs (P=0.0001 and P=0.004, respectively), with the largest differences in the post-tricuspid defect subgroup (P<0.001 and P<0.02, respectively) versus patients without PAH-SDT. By multivariable Cox analysis, with time since PAH diagnosis as time scale, New York Heart Association/World Health Organization functional class III/IV, lower peripheral arterial oxygen saturation and pretricuspid defect were associated with a higher risk of events (P=0.002, P=0.01 and P=0.04, respectively), and one or two PAH-SDTs with a lower risk of events (P=0.009). Outcomes are poor in ES, but seem better with PAH-SDT. ES with pretricuspid defects has worse outcomes despite the delayed disease onset. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  9. L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN - a randomized multicentre trial

    Directory of Open Access Journals (Sweden)

    Kraft Matthias

    2012-07-01

    Full Text Available Abstract Background Cachexia, a >10% loss of body-weight, is one factor determining the poor prognosis of pancreatic cancer. Deficiency of L-Carnitine has been proposed to cause cancer cachexia. Findings We screened 152 and enrolled 72 patients suffering from advanced pancreatic cancer in a prospective, multi-centre, placebo-controlled, randomized and double-blinded trial to receive oral L-Carnitine (4 g or placebo for 12 weeks. At entry patients reported a mean weight loss of 12 ± 2,5 (SEM kg. During treatment body-mass-index increased by 3,4 ± 1,4% under L-Carnitine and decreased (−1,5 ± 1,4% in controls (p  Conclusion While these data are preliminary and need confirmation they indicate that patients with pancreatic cancer may have a clinically relevant benefit from the inexpensive and well tolerated oral supplementation of L-Carnitine.

  10. Inherited multicentric osteolysis: case report of three siblings treated with bisphosphonate

    Directory of Open Access Journals (Sweden)

    Whitewood Colin

    2010-04-01

    Full Text Available Abstract Inherited Multicentric Osteolysis (IMO is an uncommon familial condition of idiopathic pathophysiology causing bone osteolysis and dysplasia. These patients present with common rheumatologic complaints of pain, dysfunction and disability, and are often initially misdiagnosed as a chronic rheumatic disease of childhood such as juvenile idiopathic arthritis. We report a case of three siblings diagnosed with IMO. Diagnosis was made during childhood, with each sibling having different manifestations and course of disease. One had a previous history of bilateral hip dysplasia. Two had osteolysis of the foot, distal tibia and femur (lower limb bones, whilst one had osteolysis of the rib and unusual clavicular fractures. Unusually, all siblings appear to experience decreased pain sensation compared to norms. All siblings were treated with bisphosphonates and experienced a rapid improvement in pain symptoms, decreased analgesic requirements. Two had bone mineral density testing performed and both had increases post-bisphosphonate. In all three, there was subjective evidence of stabilisation of bone disease. Testing for matrix metalloproteinase-2 (MMP2 gene was negative.

  11. Emergency IVF for embryo freezing to preserve female fertility: a French multicentre cohort study.

    Science.gov (United States)

    Courbiere, B; Decanter, C; Bringer-Deutsch, S; Rives, N; Mirallié, S; Pech, J C; De Ziegler, D; Carré-Pigeon, F; May-Panloup, P; Sifer, C; Amice, V; Schweitzer, T; Porcu-Buisson, G; Poirot, C

    2013-09-01

    What are the outcomes of French emergency IVF procedures involving embryo freezing for fertility preservation before gonadotoxic treatment? Pregnancy rates after emergency IVF, cryopreservation of embryos, storage, thawing and embryo transfer (embryo transfer), in the specific context of the preservation of female fertility, seem to be similar to those reported for infertile couples undergoing ART. A French retrospective multicentre cohort study initiated by the GRECOT network-the French Study Group for Ovarian and Testicular Cryopreservation. We sent an e-mail survey to the 97 French centres performing the assisted reproduction technique in 2011, asking whether the centre performed emergency IVF and requesting information about the patients' characteristics, indications, IVF cycles and laboratory and follow-up data. The response rate was 53.6% (52/97). Fourteen French centres reported that they performed emergency IVF (56 cycles in total) before gonadotoxic treatment, between 1999 and July 2011, in 52 patients. The patients had a mean age of 28.9 ± 4.3 years, and a median length of relationship of 3 years (1 month-15 years). Emergency IVF was indicated for haematological cancer (42%), brain tumour (23%), sarcoma (3.8%), mesothelioma (n = 1) and bowel cancer (n = 1). Gynaecological problems accounted for 17% of indications. In 7.7% of cases, emergency IVF was performed for autoimmune diseases. Among the 52 patients concerned, 28% (n = 14) had undergone previous courses of chemotherapy before beginning controlled ovarian stimulation (COS). The initiation of gonadotoxic treatment had to be delayed in 34% of the patients (n = 19). In total, 56 cycles were initiated. The mean duration of stimulation was 11.2 ± 2.5 days, with a mean peak estradiol concentration on the day on which ovulation was triggered of 1640 ± 1028 pg/ml. Three cycles were cancelled due to ovarian hyperstimulation syndrome (n = 1), poor response (n = 1) and treatment error (n = 1). A mean of 8

  12. Clinical and diagnosis characteristics of breast cancers in women with a history of radiotherapy in the first 30years of life: A French multicentre cohort study.

    Science.gov (United States)

    Demoor-Goldschmidt, C; Supiot, S; Oberlin, O; Helfre, S; Vigneron, C; Brillaud-Meflah, V; Bernier, V; Laprie, A; Ducassou, A; Claude, L; Mahé, M A; de Vathaire, F

    2017-08-01

    Irradiation (>3Gy) to the breast or axillae before 30years of age increases the risk of secondary breast cancer (SBC). The purpose of this article is to describe the clinical characteristics of SBC and the way of diagnosis in young women (before the age of national screening) in France who had received previous radiotherapy for a childhood or a young adulthood cancer. This retrospective, multicentre study reviewed the medical records of women with SBC before the age of the national screening who had received irradiation (≥3Gy) on part or all of the breast before 30years of age, for any type of tumour except BC. A total of 121 SBC were detected in 104 women with previous radiotherapy. Twenty percent of SBC were detected during regular breast screening and 16% of the women had a regular radiological follow-up. Our results points out that the main proportion of childhood cancer survivors did not benefit from the recommended breast cancer screening. This result is comparable to other previously published studies in other countries. A national screening programme is necessary and should take into account the patient's age, family history, personal medical history and previous radiotherapy to reduce the number of SBC diagnosed at an advanced stage. Copyright © 2017. Published by Elsevier B.V.

  13. Effects of unstratified and centre-stratified randomization in multi-centre clinical trials.

    Science.gov (United States)

    Anisimov, Vladimir V

    2011-01-01

    This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed. Copyright © 2010 John Wiley & Sons, Ltd.

  14. Dasatinib first-line: Multicentric Italian experience outside clinical trials.

    Science.gov (United States)

    Breccia, Massimo; Stagno, Fabio; Luciano, Luigiana; Abruzzese, Elisabetta; Annunziata, Mario; D'Adda, Mariella; Maggi, Alessandro; Sgherza, Nicola; Russo-Rossi, Antonella; Pregno, Patrizia; Castagnetti, Fausto; Iurlo, Alessandra; Latagliata, Roberto; Cedrone, Michele; Di Renzo, Nicola; Sorà, Federica; Rege-Cambrin, Giovanna; La Nasa, Giorgio; Scortechini, Anna Rita; Greco, Giovanna; Franceschini, Luca; Sica, Simona; Bocchia, Monica; Crugnola, Monica; Orlandi, Esther; Guarini, Attilio; Specchia, Giorgina; Rosti, Gianantonio; Saglio, Giuseppe; Alimena, Giuliana

    2016-01-01

    Dasatinib was approved for the treatment of chronic phase (CP) chronic myeloid leukemia (CML) patients in first line therapy based on the demonstration of efficacy and safety reported in patients enrolled in clinical trials. We describe a multicentric Italian "real-life" experience of dasatinib used as frontline treatment outside clinical trials. One hundred and nine patients (median age 54 years) were treated from January 2012 to December 2013. Increased incidence of high risk patients were detected according to stratification (26% according to Sokal score, 19% according to Euro score and 16% according to EUTOS) when compared to company sponsored studies. Median time from diagnosis to start of dasatinib was 18 days. Ten patients received unscheduled starting dose (6 patients 50mg and 4 patients 80 mg QD), whereas 99 patients started with 100mg QD. At 3 months, 92% of patients achieved a BCR-ABL ratio less than 10%. At 6 months, the rate of CCyR was 91% and the rate of MR3 was 40%, with 8% of the patients reaching MR4.5. Ninety-three patients were evaluable at 12 months: the rate of MR3 was 62%, with MR4.5 being achieved by 19% of the patients. At a median follow-up of 12 months, 27 patients (24.7%) were receiving the drug at reduced dose. Two patients (1.8%) experienced a lymphoid blast crisis and the overall incidence of resistance was 8%. As regards safety, the major side effects recorded were thrombocytopenia, neutropenia and pleural effusions, which occurred in 22%, 10% and 8% of patients, respectively. Present results, achieved in a large cohort of patients treated outside clinical trials, further confirm the efficacy and safety of dasatinib as firstline treatment in CML. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. Prospective, Multicentre, Nationwide Clinical Data from 600 Cases of Acute Pancreatitis.

    Directory of Open Access Journals (Sweden)

    Andrea Párniczky

    Full Text Available The aim of this study was to analyse the clinical characteristics of acute pancreatitis (AP in a prospectively collected, large, multicentre cohort and to validate the major recommendations in the IAP/APA evidence-based guidelines for the management of AP.Eighty-six different clinical parameters were collected using an electronic clinical research form designed by the Hungarian Pancreatic Study Group.600 adult patients diagnosed with AP were prospectively enrolled from 17 Hungarian centres over a two-year period from 1 January 2013.With respect to aetiology, biliary and alcoholic pancreatitis represented the two most common forms of AP. The prevalence of biliary AP was higher in women, whereas alcoholic AP was more common in men. Hyperlipidaemia was a risk factor for severity, lack of serum enzyme elevation posed a risk for severe AP, and lack of abdominal pain at admission demonstrated a risk for mortality. Abdominal tenderness developed in all the patients with severe AP, while lack of abdominal tenderness was a favourable sign for mortality. Importantly, lung injury at admission was associated with mortality. With regard to laboratory parameters, white blood cell count and CRP were the two most sensitive indicators for severe AP. The most common local complication was peripancreatic fluid, whereas the most common distant organ failure in severe AP was lung injury. Deviation from the recommendations in the IAP/APA evidence-based guidelines on fluid replacement, enteral nutrition and timing of interventions increased severity and mortality.Analysis of a large, nationwide, prospective cohort of AP cases allowed for the identification of important determinants of severity and mortality. Evidence-based guidelines should be observed rigorously to improve outcomes in AP.

  16. Thermal Conditions in a Simulated Office Environment with Convective and Radiant Cooling Systems

    DEFF Research Database (Denmark)

    Mustakallio, Panu; Bolashikov, Zhecho Dimitrov; Kostov, Kalin

    2013-01-01

    velocity and turbulent intensity were measured and draft rate levels calculated in the room. Manikin-based equivalent temperature (MBET) was determined by two thermal manikins to identify the impact of the local thermal conditions generated by the studied systems on occupants’ thermal comfort. The results......The thermal conditions in a two person office room were measured with four air conditioning systems: chilled beam (CB), chilled beam with radiant panel (CBR), chilled ceiling with ceiling installed mixing ventilation (CCMV) and four desk partition mounted local radiant cooling panels with mixing...

  17. Does accelerometer feedback on high-quality chest compression improve survival rate? An in-hospital cardiac arrest simulation.

    Science.gov (United States)

    Jung, Min Hee; Oh, Je Hyeok; Kim, Chan Woong; Kim, Sung Eun; Lee, Dong Hoon; Chang, Wen Joen

    2015-08-01

    We investigated whether visual feedback from an accelerometer device facilitated high-quality chest compressions during an in-hospital cardiac arrest simulation using a manikin. Thirty health care providers participated in an in-hospital cardiac arrest simulation with 1 minute of continuous chest compressions. Chest compressions were performed on a manikin lying on a bed according to visual feedback from an accelerometer feedback device. The manikin and accelerometer recorded chest compression data simultaneously. The simulated patient was deemed to have survived when the chest compression data satisfied all of the preset high-quality chest compression criteria (depth ≥51 mm, rate >100 per minute, and ≥95% full recoil). Survival rates were calculated from the feedback device and manikin data. The survival rate according to the feedback device data was 80%; however, the manikin data indicated a significantly lower survival rate (46.7%; P = .015). The difference between the accelerometer and manikin survival rates was not significant for participants with a body mass index greater than or equal to 20 kg/m(2) (93.3 vs 73.3%, respectively; P = .330); however, the difference in survival rate was significant in participants with body mass index less than 20 kg/m(2) (66.7 vs 20.0%, respectively; P = .025). The use of accelerometer feedback devices to facilitate high-quality chest compression may not be appropriate for lightweight rescuers because of the potential for compression depth overestimation. Clinical Research Information Service (KCT0001449). Copyright © 2015 Elsevier Inc. All rights reserved.

  18. [Introduction of capillary glycosylated haemoglobin determination in a Primary Care Health Area: Multicentre study of the evolution of patients with type 2 diabetes mellitus].

    Science.gov (United States)

    Núñez-Sánchez, M Á; Cervantes-Cuesta, M Á; Brocal-Ibañez, P; Salmeron-Arjona, E; León-Martínez, L P; Cerezo-Sanmartin, M

    The aim of this study was to evaluate the efficiency of a joint intervention that included educational components, self-assessment, and information to optimise diabetes control through the introduction of instant capillary glycosylated haemoglobin (HbA1c) determination in Primary Care. A multicentre prospective descriptive study was carried out over 3years in 10Primary Care Centres of the Area VII Murcia East. At the end of the study there were 804 patients with type 2 diabetes (DM2). Patients were divided into 4 groups based on initial values of HbA1c, and if changes in their treatment were needed. HbA1c, body mass index, and blood pressure were monitored. A financial assessment was also performed on the impact of the implementation of a protocol to measure instant capillary RESULTS: A significant reduction was observed in HbA1c values. The initial HbA1c mean value was 7.4±1.4%, which decreased to a final value of 6.9±1.0% (P<.001). At the end of the study, 71.4% of patients included reached diabetic control objectives. In addition, the financial assessment demonstrated that the implementation of this diabetes control system led to a decrease of the 24.7% in spending on glucose strips after the first year of study in Area VII Murcia Health Service. The introduction of capillary HbA1c determination in Primary Care has demonstrated to improve diabetes control and the efficiency of the health personnel. Furthermore, a reduction in the health costs of patients with DM2 was also shown. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  19. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Directory of Open Access Journals (Sweden)

    Jimenez Carmen

    2005-10-01

    Full Text Available Abstract Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. The patients will be randomised into two groups: 1 experimental (acupuncture + physiotherapy; 2 control (TENS-placebo + physiotherapy; the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA Scale

  20. Thermal environment in a simulated double office room with convective and radiant cooling systems

    DEFF Research Database (Denmark)

    Mustakallio, Panu; Bolashikov, Zhecho Dimitrov; Rezgals, Lauris

    2017-01-01

    anddraught rate was calculated. Manikin-based equivalent temperature (MBET) was determined by using two thermal manikins. CCMV provided slightly more uniform thermal environment and the least sensitive to different workstation layouts than the other systems. CB provided a bit higher draught rate levels than...