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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. 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. 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/

  4. 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.

  5. 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...

  6. 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.

  7. 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.

  8. 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.

  9. 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

  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. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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...

  16. 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

  17. 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/

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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

  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

    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.

  4. 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

  5. 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...

  6. 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

  7. 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.

  8. 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

  9. 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

  10. A comparison of direct and indirect laryngoscopes and the ILMA in novice users: a manikin study.

    LENUS (Irish Health Repository)

    Maharaj, C H

    2007-11-01

    Direct laryngoscopic tracheal intubation using the Macintosh laryngoscope is taught to many healthcare professionals as it is a potentially life-saving procedure. However, it is a difficult skill to acquire and maintain. Several alternative intubation devices exist that may provide a better view of the glottis and require less skill to use. We conducted a prospective, randomised trial of four different laryngoscopes and the ILMA in 30 medical students who had no prior airway management experience. The devices were tested in both normal and cervical immobilisation laryngoscopy scenarios. Following brief didactic instruction, each participant took turns performing laryngoscopy and intubation using each device under direct supervision. Each student was allowed up to three intubation attempts with each device, in each scenario. The Airtraq, McCoy, and the ILMA each demonstrated advantages over the Macintosh laryngoscope. In both the easy and difficult airway scenarios, the Airtraq, McCoy, and the ILMA reduced the number of intubation attempts, and reduced the number of optimisation manoeuvres required. The Airtraq and ILMA reduced the severity of dental trauma in both scenarios. The performance of the other devices studied was more variable. Overall, participants found that only the Airtraq was less difficult to use and they were more confident using it compared to the Macinosh laryngoscope.

  11. 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...

  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. A Multicentre Study of Thromboprophylaxis in Pregnancy

    LENUS (Irish Health Repository)

    Crowley, MP

    2017-05-01

    Venous thromboembolism (VTE) is a leading cause of maternal mortality. The risk increases with increasing maternal age, mode of delivery and medical co-morbidities. Thromboprophylaxis with low molecular weight heparin (LMWH) has been shown to be both safe and efficacious. The aim of this study was to prospectively investigate the incidence of maternal risk factors in pregnant women admitted to hospital, to calculate their VTE risk status and to investigate if they were receiving appropriate thromboprophylaxis. All patients admitted to the participating hospitals on the day of investigation were assessed for risk of VTE on the basis of hospital chart review. Five Hundred and forty women were recruited from 16 hospitals. Almost 32% (31.7%) were receiving thromboprophylaxis with LMWH. Just under 80% of patients were on the correct thromboprophylaxis strategy as defined by the RCOG guideline but 49% were under-dosed. The odds of receiving appropriate thromboprophylaxis were significantly increased if the woman was >35 years 0or with parity>3.

  14. 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

  15. 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.

  16. 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

  17. 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.

  18. 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)

  19. 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.

  20. 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.

  1. 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.

  2. 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...

  3. 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...

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Basic life support training into cardiac rehabilitation programs: A chance to give back. A community intervention controlled manikin study.

    Science.gov (United States)

    González-Salvado, Violeta; Abelairas-Gómez, Cristian; Peña-Gil, Carlos; Neiro-Rey, Carmen; Barcala-Furelos, Roberto; González-Juanatey, José Ramón; Rodríguez-Núñez, Antonio

    2018-03-12

    Early basic life support is crucial to enhance survival from out-of-hospital cardiac arrest but rates remain low, especially in households. High-risk groups' training has been advocated, but the optimal method is unclear. The CArdiac REhabilitation and BAsic life Support (CAREBAS) project aims to compare the effectiveness of two basic life support educational strategies implemented in a cardiac rehabilitation program. A community intervention study including consecutive patients enrolled on an exercise-based cardiac rehabilitation program after acute coronary syndrome or revascularization was conducted. A standard basic life support training (G-Stan) and a novel approach integrating cardiopulmonary resuscitation hands-on rolling refreshers (G-CPR) were randomly assigned to each group and compared. Basic life support performance was assessed by means of simulation at baseline, following brief instruction and after the 2-month program. 114 participants were included and 108 completed the final evaluation (G-Stan:58, G-CPR:50). Basic life support performance was equally poor at baseline and significantly improved following a brief instruction. A better skill retention was found after the 2-month program in G-CPR, significantly superior for safety and sending for an automated external defibrillator. Confidence and self-perceived preparation were also significantly greater in G-CPR after the program. Integrating cardiopulmonary resuscitation hands-on rolling refreshers in the training of an exercise-based cardiac rehabilitation program is feasible and improves patients' skill retention and confidence to perform a basic life support sequence, compared to conventional training. Exporting this formula to other programs may result in increased numbers of trained citizens, enhanced social awareness and bystander resuscitation. Copyright © 2018 Elsevier B.V. All rights reserved.

  11. 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...

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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...

  19. 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

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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...

  6. 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.

  7. 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...

  8. 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...

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

    NARCIS (Netherlands)

    Madsen, M.B.; Skrede, S.; Bruun, T.; Arnell, P.; Rosén, A.; Nekludov, M.; Karlsson, Y.; Bergey, F.; Saccenti, E.; Martins dos Santos, V.A.P.; Perner, A.; Norrby-Teglund, A.; Hyldegaard, O.

    2018-01-01

    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

  10. Multicentre study of Wilm's tumours treated by different therapeutic ...

    African Journals Online (AJOL)

    National Wilm's Tumour Study (NWTS) group and the. International ... improvement in the survival of children with cancer in ... at diagnosis, sex, incidence, presenting symptoms, pre- ... localized in the left kidney in 22 (55%) patients, the right.

  11. Prospective, Controlled, Multicentre Study of Loperimide in Pregnancy

    Directory of Open Access Journals (Sweden)

    A Einarson

    2000-01-01

    Full Text Available BACKGROUND: Loperamide is a synthetic piperidine derivative used for the treatment of both acute and chronic diarrhea. Little is known about its safety and risk in pregnancy. Human data are limited to one surveillance study of Michigan Medicaid patients, with 108 women exposed in the first trimester. In this study there were six major birth defects, three of which were cardiovascular anomalies.

  12. Diversity of Pneumocystis jirovecii Across Europe: A Multicentre Observational Study

    Directory of Open Access Journals (Sweden)

    Alexandre Alanio

    2017-08-01

    Our study showed the wide population diversity across Europe, with evidence of local clusters of patients harbouring a given genotype. These data suggest a specific association between genotype and underlying disease, with evidence of a different natural history of PCP in HIV patients and renal transplant recipients.

  13. 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.

  14. Peptic Ulcer Disease in Bangladesh: A Multi-centre Study.

    Science.gov (United States)

    Ghosh, C K; Khan, M R; Alam, F; Shil, B C; Kabir, M S; Mahmuduzzaman, M; Das, S C; Masud, H; Roy, P K

    2017-01-01

    The incidence of peptic ulcer has steadily declined through out the world. This decreasing trend is also noticeable in this subcontinent. The point prevalence of peptic ulcer (PUD) in Bangladesh was around 15% in eighties. The aim of this study was to see the present prevalence of peptic ulcer at endoscopy and to identify changing trends in the occurrence of peptic ulcer in Bangladesh. This retrospective analysis of the endoscopic records of multiple tertiary referral centres of Dhaka city were done from January 2012 to July 2013. A total of 5608 subjects were the study samples. We included those patients having peptic ulcer in the form of duodenal ulcer, benign gastric ulcer including pre-pyloric ulcer and gastric outlet obstruction due to peptic ulcer. Duodenal ulcer and benign gastric ulcer were found in 415(7.4%) and 184(3.28%) patients respectively and gastric outlet obstruction due to peptic ulcer was found in 23(0.40%) patients.

  15. Postoperative radiotherapy of uterine sarcoma: A multicentric retrospective study

    International Nuclear Information System (INIS)

    Champetier, C.; Cowen, D.; Hannoun-Levi, J.M.; Resbeut, M.; Azria, D.; Salem, N.; Tessier, E.; Ellis, S.

    2011-01-01

    Purpose. - Surgery is the treatment of choice for localized uterine sarcomas. We conducted a retrospective study to define prognostic factors. Patients and methods. - We studied 111 cases of patients treated by adjuvant radiotherapy for uterine sarcoma in seven French centers. The median decline was 31 months. We conducted a univariate analysis to identify factors correlated with local recurrence. The statistically significant factors were studied in multivariate analysis by Cox model. Results. - The median dose of external beam radiotherapy was 45 Gy. Forty-three percent of patients had vaginal vault brachytherapy and 21 % chemotherapy. Only 6.3 % of patients had complications of acute grade III and 8.1 % of long-term sequelae of radiotherapy. The survival rate at 5 years was 74.6 %. They noted 12.6 % of isolated locoregional recurrences, against 29.7 % for distant recurrences, 80 % were pulmonary. Factors correlated with the risk of locoregional relapse were menopausal status (P = 0.045) and surgical margins suspicious or not healthy (P = 0.0095). The chemotherapy did not improve overall survival or disease free survival but the numbers were low. Conclusion. - The postoperative radiotherapy provides good local control in this disease. Brachytherapy is sometimes done, but it does not improve local control. Chemotherapy is not a standard localized stage but the rate of metastatic recurrence calls for the development of strategies involving systemic treatment with radiotherapy. (authors)

  16. [Multicentre study of infection incidence in knee prosthesis].

    Science.gov (United States)

    Jaén, F; Sanz-Gallardo, M I; Arrazola, M P; García de Codes, A; de Juanes, A; Resines, C

    2012-01-01

    To determine the incidence of surgical site infection in knee prosthesis surgical procedure for a follow-up period of one year in twelve hospitals in Madrid region. A prospective study was carried out from January to December 2009 using a national surveillance system called Indicadores Clínicos de Mejora Continua de Calidad. Primary and revision knee joint replacements in patients operated on in the previous year were included. Criteria used to define surgical site infection and patient risk index categories were those established by the Centers for Disease Control and Prevention and National Nosocomial Infections Surveillance. The incidence rates were worked out crude and adjusted by hazard ratio. 2,088 knee prosthesis procedures were analyzed. The overall incidence of surgical site infection was 2.1%. Sixty-five percent of the infections were organ/space. Sixty percent of the infections were identified in the early postoperative period. Of all surgical site infections, 41.9% were microbiologically confirmed. Antibiotic prophylaxis was implemented correctly in 63.3% of the cases. The most important cause of inappropriate prophylaxis was an unsuitable duration in 85.7% of the cases. The presurgical preparation was carried out correctly in 50.3% of surgical operations. The incidence of knee arthroplasty infection was twice as high as in the National Healthcare Safety Network and similar to national rates. In this study, the incidence of infection was within the range of infection rates in other published European studies. Surveillance and control strategies of health care for associated infections allow us to assess trends and the impact of preventive measures. Copyright © 2011 SECOT. Published by Elsevier Espana. All rights reserved.

  17. Validation of protein carbonyl measurement: A multi-centre study

    Directory of Open Access Journals (Sweden)

    Edyta Augustyniak

    2015-04-01

    Full Text Available Protein carbonyls are widely analysed as a measure of protein oxidation. Several different methods exist for their determination. A previous study had described orders of magnitude variance that existed when protein carbonyls were analysed in a single laboratory by ELISA using different commercial kits. We have further explored the potential causes of variance in carbonyl analysis in a ring study. A soluble protein fraction was prepared from rat liver and exposed to 0, 5 and 15 min of UV irradiation. Lyophilised preparations were distributed to six different laboratories that routinely undertook protein carbonyl analysis across Europe. ELISA and Western blotting techniques detected an increase in protein carbonyl formation between 0 and 5 min of UV irradiation irrespective of method used. After irradiation for 15 min, less oxidation was detected by half of the laboratories than after 5 min irradiation. Three of the four ELISA carbonyl results fell within 95% confidence intervals. Likely errors in calculating absolute carbonyl values may be attributed to differences in standardisation. Out of up to 88 proteins identified as containing carbonyl groups after tryptic cleavage of irradiated and control liver proteins, only seven were common in all three liver preparations. Lysine and arginine residues modified by carbonyls are likely to be resistant to tryptic proteolysis. Use of a cocktail of proteases may increase the recovery of oxidised peptides. In conclusion, standardisation is critical for carbonyl analysis and heavily oxidised proteins may not be effectively analysed by any existing technique.

  18. Young ischemic stroke in Tunisia: a multicentric study.

    Science.gov (United States)

    Kefi, Asma; Larbi, Thara; Abdallah, Meya; Ouni, Amira El; Bougacha, Neil; Bouslama, Kamel; Hamzaoui, Saloua; M'rad, Skander

    2017-04-01

    There is wanting data regarding young ischemic stroke in developing countries, especially in Tunisia. The purpose of this study was to investigate risk factors and etiologies of young ischemic stroke in Tunisian and make a comparison with previous reports. A total of 102 young ischemic stroke patients (15-45 years old) were admitted, between January 1996 and August 2007, to 11 departments of internal medicine in different Tunisian hospitals. The risk factors for stroke were documented and assessed. Diagnosis workup consisted of anamnesis, complete physical examination and extensive laboratory, radiologic, immunologic, neurologic and cardiologic examination. Stroke etiologies were classified according the Trial of ORG 10172 in acute stroke treatment. There were 42 men (41.2%) and 60 women (58.89%) with a mean age at onset of 35.7 years. As regards stroke subtype, large-artery atherosclerosis was diagnosed in 6.9% of cases, cardioembolism in 11.8%, small-vessel occlusion in 8.8%, other determined etiology in 37.3% and undetermined etiology in 35.3%. Concerning the traditional risk factors, smoking (31.4%), hypertension and diabetes mellitus (12.7% for each one) and a family history of stroke (10.8%) were the most common. The mean follow-up period was 30.5 months. In our study, traditional risk factors were not-so-uncommon in young adults with ischemic stroke suggesting that prevention can go through controlling these factors. Stroke of other determined etiology was the most common among our patients, so that a broad and detailed diagnostic workup is crucial to puzzle out the etiology for more and better stroke prevention.

  19. The learning environment and medical student burnout: a multicentre study.

    Science.gov (United States)

    Dyrbye, Liselotte N; Thomas, Matthew R; Harper, William; Massie, F Stanford; Power, David V; Eacker, Anne; Szydlo, Daniel W; Novotny, Paul J; Sloan, Jeff A; Shanafelt, Tait D

    2009-03-01

    Little is known about specific personal and professional factors influencing student distress. The authors conducted a comprehensive assessment of how learning environment, clinical rotation factors, workload, demographics and personal life events relate to student burnout. All medical students (n = 3080) at five medical schools were surveyed in the spring of 2006 using a validated instrument to assess burnout. Students were also asked about the aforementioned factors. A total of 1701 medical students (response rate 55%) completed the survey. Learning climate factors were associated with student burnout on univariate analysis (odds ratio [OR] 1.36-2.07; all P burnout (ORs 1.69 and 1.48, respectively; both P student burnout. Students who experienced a positive personal life event had a lower frequency of burnout (OR 0.70; P burnout than students who did not experience a negative personal life event. On multivariate analysis personal characteristics, learning environment and personal life events were all independently related to student burnout. Although a complex array of personal and professional factors influence student well-being, student satisfaction with specific characteristics of the learning environment appears to be a critical factor. Studies determining how to create a learning environment that cultivates student well-being are needed.

  20. Breast sarcoma surgical management: a five-year multicentric study

    Directory of Open Access Journals (Sweden)

    Răzvan V. Scăunașu

    2016-11-01

    Full Text Available Background. Breast sarcomas are a heterogeneous group of breast neoplasms with a low incidence and a reserved prognosis. No treatment protocol has been yet established, a guideline similar to soft tissue sarcomas is used. Materials and Methods. Our study analyzed all the patients admitted with the diagnosis of malignant breast disease in two specialized centers on a five-year time frame. We compared long term results for the patients who underwent conservative treatment and mastectomy. Results. A total of 76 cases received surgical treatment with curative intent, 24 conservative procedures and 52 mastectomies. Incidence of local recurrence does not appear to be closely related to the type of surgical procedure. There were a number of five local recurrences for patients who received conservative treatment and 7 local recurrences where we used mastectomy. Kaplan-Meier analysis conducted shows no differences statistically significant (sig = 0.459 between the results of conservative treatment and mastectomy. Basically conservative surgery seems to get similar results, provided that R0 resection objective can be met. Conclusions. Treatment options are more limited for breast sarcomas than carcinomas, the role of surgery being more important to therapeutic success. The biological characteristic of the tumor including histological type and sub-type, play an important role in determining the results and the treatment should be tailored and adapted for each case.

  1. Benchmarking of surgical complications in gynaecological oncology: prospective multicentre study.

    Science.gov (United States)

    Burnell, M; Iyer, R; Gentry-Maharaj, A; Nordin, A; Liston, R; Manchanda, R; Das, N; Gornall, R; Beardmore-Gray, A; Hillaby, K; Leeson, S; Linder, A; Lopes, A; Meechan, D; Mould, T; Nevin, J; Olaitan, A; Rufford, B; Shanbhag, S; Thackeray, A; Wood, N; Reynolds, K; Ryan, A; Menon, U

    2016-12-01

    To explore the impact of risk-adjustment on surgical complication rates (CRs) for benchmarking gynaecological oncology centres. Prospective cohort study. Ten UK accredited gynaecological oncology centres. Women undergoing major surgery on a gynaecological oncology operating list. Patient co-morbidity, surgical procedures and intra-operative (IntraOp) complications were recorded contemporaneously by surgeons for 2948 major surgical procedures. Postoperative (PostOp) complications were collected from hospitals and patients. Risk-prediction models for IntraOp and PostOp complications were created using penalised (lasso) logistic regression using over 30 potential patient/surgical risk factors. Observed and risk-adjusted IntraOp and PostOp CRs for individual hospitals were calculated. Benchmarking using colour-coded funnel plots and observed-to-expected ratios was undertaken. Overall, IntraOp CR was 4.7% (95% CI 4.0-5.6) and PostOp CR was 25.7% (95% CI 23.7-28.2). The observed CRs for all hospitals were under the upper 95% control limit for both IntraOp and PostOp funnel plots. Risk-adjustment and use of observed-to-expected ratio resulted in one hospital moving to the >95-98% CI (red) band for IntraOp CRs. Use of only hospital-reported data for PostOp CRs would have resulted in one hospital being unfairly allocated to the red band. There was little concordance between IntraOp and PostOp CRs. The funnel plots and overall IntraOp (≈5%) and PostOp (≈26%) CRs could be used for benchmarking gynaecological oncology centres. Hospital benchmarking using risk-adjusted CRs allows fairer institutional comparison. IntraOp and PostOp CRs are best assessed separately. As hospital under-reporting is common for postoperative complications, use of patient-reported outcomes is important. Risk-adjusted benchmarking of surgical complications for ten UK gynaecological oncology centres allows fairer comparison. © 2016 Royal College of Obstetricians and Gynaecologists.

  2. Infectious sacroiliitis: a retrospective, multicentre study of 39 adults

    Directory of Open Access Journals (Sweden)

    Hermet Marion

    2012-11-01

    Full Text Available Abstract Background Non-brucellar and non-tuberculous infectious sacroiliitis (ISI is a rare disease, with misleading clinical signs that delay diagnosis. Most observations are based on isolated case reports or small case series. Our aim was to describe the clinical, bacteriological, and radiological characteristics of ISI, as well as the evolution of these arthritis cases under treatment. Methods This retrospective study included all ISI cases diagnosed between 1995 and 2011 in eight French rheumatology departments. ISI was diagnosed if sacroiliitis was confirmed bacteriologically or, in the absence of pathogenic agents, if clinical, biological, and radiological data was compatible with this diagnosis and evolution was favourable under antibiotic therapy. Results Overall, 39 cases of ISI were identified in adults, comprising 23 women and 16 men, with a mean age at diagnosis of 39.7 ± 18.1 years. The left sacroiliac joint (SI was affected in 59% of cases, with five cases occurring during the post-partum period. Lumbogluteal pain was the most common symptom (36/39. Manipulations of the SI joint were performed in seven patients and were always painful. Mean score for pain using the visual analogue score was 7.3/10 at admission, while 16 patients were febrile at diagnosis. No risk factor was found for 30.7% of patients. A diagnosis of ISI was only suspected in five cases at admission. The mean time to diagnosis was long, being 43.3 ± 69.1 days on average. Mean C-reactive protein was 149.7 ± 115.3 mg/l, and leukocytosis (leukocytes ≥ 10 G/l was uncommon (n = 15 (mean level of leukocytes 10.4 ± 3.5 G/l. Radiographs (n = 33 were abnormal in 20 cases, revealing lesions of SI, while an abdominopelvic computed tomography (CT scan (n = 27 was abnormal in 21 cases, suggesting arthritis of the SI joints in 13 cases (48.1% and a psoas abscess in eight. Bone scans (n = 14 showed hyperfixation of the SI in 13 cases

  3. 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

  4. 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...

  5. 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...

  6. 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.

  7. 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.

  8. 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...

  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. 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...

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. 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...

  16. 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.

  17. 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.

  18. 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

  19. 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

  20. 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.

  1. 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

  2. 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-...

  3. 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

  4. 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.

  5. 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.

  6. 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.)

  7. 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.

  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. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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...

  16. 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.

  17. 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

  18. 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

  19. Induction of a shorter compression phase is correlated with a deeper chest compression during metronome-guided cardiopulmonary resuscitation: a manikin study.

    Science.gov (United States)

    Chung, Tae Nyoung; Bae, Jinkun; Kim, Eui Chung; Cho, Yun Kyung; You, Je Sung; Choi, Sung Wook; Kim, Ok Jun

    2013-07-01

    Recent studies have shown that there may be an interaction between duty cycle and other factors related to the quality of chest compression. Duty cycle represents the fraction of compression phase. We aimed to investigate the effect of shorter compression phase on average chest compression depth during metronome-guided cardiopulmonary resuscitation. Senior medical students performed 12 sets of chest compressions following the guiding sounds, with three down-stroke patterns (normal, fast and very fast) and four rates (80, 100, 120 and 140 compressions/min) in random sequence. Repeated-measures analysis of variance was used to compare the average chest compression depth and duty cycle among the trials. The average chest compression depth increased and the duty cycle decreased in a linear fashion as the down-stroke pattern shifted from normal to very fast (pmetronome-guided cardiopulmonary resuscitation.

  20. 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

  1. Basic life support and automated external defibrillator skills among ambulance personnel: a manikin study performed in a rural low-volume ambulance setting

    Directory of Open Access Journals (Sweden)

    Nielsen Anne

    2012-05-01

    Full Text Available Abstract Background Ambulance personnel play an essential role in the ‘Chain of Survival’. The prognosis after out-of-hospital cardiac arrest was dismal on a rural Danish island and in this study we assessed the cardiopulmonary resuscitation performance of ambulance personnel on that island. Methods The Basic Life Support (BLS and Automated External Defibrillator (AED skills of the ambulance personnel were tested in a simulated cardiac arrest. Points were given according to a scoring sheet. One sample t test was used to analyze the deviation from optimal care according to the 2005 guidelines. After each assessment, individual feedback was given. Results On 3 consecutive days, we assessed the individual EMS teams responding to OHCA on the island. Overall, 70% of the maximal points were achieved. The hands-off ratio was 40%. Correct compression/ventilation ratio (30:2 was used by 80%. A mean compression depth of 40–50 mm was achieved by 55% and the mean compression depth was 42 mm (SD 7 mm. The mean compression rate was 123 per min (SD 15/min. The mean tidal volume was 746 ml (SD 221 ml. Only the mean tidal volume deviated significantly from the recommended (p = 0.01. During the rhythm analysis, 65% did not perform any visual or verbal safety check. Conclusion The EMS providers achieved 70% of the maximal points. Tidal volumes were larger than recommended when mask ventilation was applied. Chest compression depth was optimally performed by 55% of the staff. Defibrillation safety checks were not performed in 65% of EMS providers.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  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. 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.

  12. 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.

  13. 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.

  14. 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...

  15. 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.)

  16. 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

  17. 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

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: international multicentre prospective study.

    Science.gov (United States)

    Stanley, Adrian J; Laine, Loren; Dalton, Harry R; Ngu, Jing H; Schultz, Michael; Abazi, Roseta; Zakko, Liam; Thornton, Susan; Wilkinson, Kelly; Khor, Cristopher J L; Murray, Iain A; Laursen, Stig B

    2017-01-04

     To compare the predictive accuracy and clinical utility of five risk scoring systems in the assessment of patients with upper gastrointestinal bleeding.  International multicentre prospective study.  Six large hospitals in Europe, North America, Asia, and Oceania.  3012 consecutive patients presenting over 12 months with upper gastrointestinal bleeding.  Comparison of pre-endoscopy scores (admission Rockall, AIMS65, and Glasgow Blatchford) and post-endoscopy scores (full Rockall and PNED) for their ability to predict predefined clinical endpoints: a composite endpoint (transfusion, endoscopic treatment, interventional radiology, surgery, or 30 day mortality), endoscopic treatment, 30 day mortality, rebleeding, and length of hospital stay. Optimum score thresholds to identify low risk and high risk patients were determined.  The Glasgow Blatchford score was best (area under the receiver operating characteristic curve (AUROC) 0.86) at predicting intervention or death compared with the full Rockall score (0.70), PNED score (0.69), admission Rockall score (0.66, and AIMS65 score (0.68) (all P<0.001). A Glasgow Blatchford score of ≤1 was the optimum threshold to predict survival without intervention (sensitivity 98.6%, specificity 34.6%). The Glasgow Blatchford score was better at predicting endoscopic treatment (AUROC 0.75) than the AIMS65 (0.62) and admission Rockall scores (0.61) (both P<0.001). A Glasgow Blatchford score of ≥7 was the optimum threshold to predict endoscopic treatment (sensitivity 80%, specificity 57%). The PNED (AUROC 0.77) and AIMS65 scores (0.77) were best at predicting mortality, with both superior to admission Rockall score (0.72) and Glasgow Blatchford score (0.64; P<0.001). Score thresholds of ≥4 for PNED, ≥2 for AIMS65, ≥4 for admission Rockall, and ≥5 for full Rockall were optimal at predicting death, with sensitivities of 65.8-78.6% and specificities of 65.0-65.3%. No score was helpful at predicting rebleeding or length

  7. 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 ...

  8. 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...

  9. 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

  10. 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:

  11. 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/

  12. 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

  13. 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.

  14. 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

  15. 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.

  16. 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...

  17. 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

  18. 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...

  19. 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

  20. 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.

  1. 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

  2. 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....

  3. 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...

  4. 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

  5. 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.

  6. 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

  7. 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...

  8. 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.

  9. 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.

  10. 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

  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. 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.

  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. 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.

  16. 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

  17. 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.

  18. 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/

  19. 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...

  20. 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

  1. 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...

  2. 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)

  3. 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.

  4. 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...

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  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. 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. 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.

  17. 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.

  18. 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

  19. 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...

  20. 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...

  1. 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.

  2. 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.

  3. [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.

  4. 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/

  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 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. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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

  16. 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.

  17. 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

  18. 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...

  19. 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.

  20. 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

  1. [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.

  2. 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.

  3. 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.

  4. 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

  5. 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...

  6. 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...

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

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

    NARCIS (Netherlands)

    McAuliffe, C.; Corcoran, P.; Keeley, H.S.; Arensman, E.; Bille Brahe, U.; de Leio, D.; Fekete, S.; Hawton, K.; Hjelmeland, H.; Kelleher, M.; Kerkhof, A.J.F.M.; Lonnqvist, J.; Michel, K.; Salander Renberg, E.; Schmidtke, A.; van Heeringen, K.; Wasserman, D.

    2006-01-01

    Background. 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

  13. Quality of pain treatment after caesarean section : Results of a multicentre cohort study

    NARCIS (Netherlands)

    Marcus, H.; Gerbershagen, H. J.; Peelen, Linda M.; Aduckathil, S.; Kappen, T. H.; Kalkman, C. J.; Meissner, W.; Stamer, U. M.; Peelen, LM

    BackgroundA large cohort study recently reported high pain scores after caesarean section (CS). The aim of this study was to analyse how pain after CS interferes with patients' activities and to identify possible causes of insufficient pain treatment. MethodsWe analysed pain scores, pain-related

  14. A multicentre weight loss study using a low-calorie diet over 8 weeks

    DEFF Research Database (Denmark)

    Papadaki, Angeliki; Linardakis, Manolis; Plada, Maria

    2013-01-01

    The efficacy of low-calorie diets (LCDs) has not been investigated in large-scale studies or among people from different regions, who are perhaps unaccustomed to such methods of losing weight. The aim of the present study was to investigate changes in obesity measures among overweight/obese adults...

  15. 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

  16. 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.

  17. 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

  18. Computers and internet in dental education system of Kerala, South India: A multicentre study

    Directory of Open Access Journals (Sweden)

    Kanakath Harikumar

    2015-01-01

    Full Text Available Computers and internet have exerted a tremendous effect on dental education programs all over the world. A multicenter study was done to assess trends in computer and internet usage among the dental students and faculty members across the South Indian state, Kerala. A total of 347 subjects participated in the study. All participants were highly competent with the use of computers and internet. 72.3% of the study subjects preferred hard copy textbooks to PDF format books. 81.3% of the study subjects thought that internet was a useful adjunct to dental education. 73.8% of the study subjects opined that computers and internet could never be a replacement to conventional classroom teaching. Efforts should be made to provide greater infrastructure with regard to computers and internet such as Wi-Fi, free, unlimited internet access to all students and faculty members.

  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. Collecting core data in severely injured patients using a consensus trauma template: an international multicentre study

    DEFF Research Database (Denmark)

    Ringdal, Kjetil G; Lossius, Hans Morten; Jones, J Mary

    2011-01-01

    ABSTRACT: INTRODUCTION: No worldwide, standardised definitions exist for documenting, reporting, and comparing data from severely injured trauma patients. This study evaluated the feasibility of collecting the data variables of the international consensus-derived Utstein Trauma Template. METHODS:...

  1. Community and Healthcare Providers' Perspectives on Male Circumcision: A Multi-Centric Qualitative Study in India

    OpenAIRE

    Sahay, Seema; Nagarajan, Karikalan; Mehendale, Sanjay; Deb, Sibnath; Gupta, Abhilasha; Bharat, Shalini; Bhatt, Shripad; Kumar, Athokpam Bijesh; Kanthe, Vidisha; Sinha, Anju; Chandhiok, Nomita

    2014-01-01

    Background Although male circumcision (MC) is recommended as an HIV prevention option, the religious, cultural and biomedical dimensions of its feasibility, acceptability and practice in India have not been explored till date. This study explores beliefs, experiences and understanding of the community and healthcare providers (HCPs) about adult MC as an HIV prevention option in India. Methods This qualitative study covered 134 in-depth interviews from Belgaum, Kolkata, Meerut and Mumbai citie...

  2. Urea cycle disorders in Spain: an observational, cross-sectional and multicentric study of 104 cases

    OpenAIRE

    Martín-Hernández, Elena; Aldámiz-Echevarría, Luis; Castejón-Ponce, Esperanza; Pedrón-Giner, Consuelo; Couce, María Luz; Serrano-Nieto, Juliana; Pintos-Morell, Guillem; Bélanger-Quintana, Amaya; Martínez-Pardo, Mercedes; García-Silva, María Teresa; Quijada-Fraile, Pilar; Vitoria-Miñana, Isidro; Dalmau, Jaime; Lama-More, Rosa A; Bueno-Delgado, María Amor

    2014-01-01

    Background Advances in the diagnosis and treatment of urea cycle disorders (UCDs) have led to a higher survival rate. The purpose of this study is to describe the characteristics of patients with urea cycle disorders in Spain. Methods Observational, cross-sectional and multicenter study. Clinical, biochemical and genetic data were collected from patients with UCDs, treated in the metabolic diseases centers in Spain between February 2012 and February 2013, covering the entire Spanish populatio...

  3. Assessment of quality of life and functional outcome in patients sustaining moderate and major trauma: a multicentre, prospective cohort study.

    Science.gov (United States)

    Rainer, T H; Yeung, J H H; Cheung, S K C; Yuen, Y K Y; Poon, W S; Ho, H F; Kam, C W; Cattermole, G N; Chang, A; So, F L; Graham, C A

    2014-05-01

    Trauma care systems aim to reduce both death and disability, yet there is little data on post-trauma health status and functional outcome. To evaluate baseline, discharge, six month and 12 month post-trauma quality of life, functional outcome and predictors of quality of life in Hong Kong. Multicentre, prospective cohort study using data from the trauma registries of three regional trauma centres in Hong Kong. Trauma patients with an ISS≥9 and aged≥18 years were included. The main outcome measures were the physical component summary (PCS) score and mental component summary (MCS) scores of the Short-Form 36 (SF36) for health status, and the extended Glasgow Outcome Scale (GOSE) for functional outcome. Between 1 January 2010 and 31 September 2010, 400 patients (mean age 53.3 years; range 18-106; 69.5% male) were recruited to the study. There were no statistically significant differences in baseline characteristics between responders (N=177) and surviving non-responders (N=163). However, there were significant differences between these groups and the group of patients who died (N=60). Only 16/400 (4%) cases reported a GOSE≥7. 62/400 (15.5%) responders reached the HK population norm for PCS. 125/400 (31%) responders reached the HK population norm for MCS. If non-responders had similar outcomes to responders, then the percentages for GOSE≥7 would rise from 4% to 8%, for PCS from 15.5% to 30%, and for MCS from 31% to 60%. Univariate analysis showed that 12-month poor quality of life was significantly associated with age>65 years (OR 4.77), male gender (OR 0.44), pre-injury health problems (OR 2.30), admission to ICU (OR 2.15), ISS score 26-40 (OR 3.72), baseline PCS (OR 0.89), one-month PCS (OR 0.89), one-month MCS (OR 0.97), 6-month PCS (OR 0.76) and 6-month MCS (OR 0.97). For patients sustaining moderate or major trauma in Hong Kong at 12 months after injury<1 in 10 patients had an excellent recovery, ≤3 in 10 reached a physical health status score

  4. 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

  5. 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.

  6. Adherence to MRI protocol consensus guidelines in multiple sclerosis: an Australian multi-centre study

    International Nuclear Information System (INIS)

    Curley, Michael; Josey, Lawrence; Lucas, Robyn; Dear, Keith; Taylor, Bruce V.; Coulthard, Alan; Ausimmune Investigator Group

    2012-01-01

    Multiple sclerosis (MS) is a debilitating disease that causes significant morbidity within a young demographic. Diagnostic guidelines for MS have evolved, and imaging has played an increasingly important role in diagnosis over the last two decades. For imaging to contribute to diagnosis in a meaningful way, it must be reproducible. Consensus guidelines for MRI in MS exist to define correct sequence type and imaging technique, but it is not clear to what extent they are followed. This study reviewed MRI studies performed on Australian individuals presenting with a first clinical diagnosis of central nervous system demyelination (FCD) for adherence to published guidelines and discussed practical implementation of MS guidelines in light of recent updates. The Ausimmune study was a prospective case control study of Australian participants presenting with FCD from 2003 to 2006. Baseline cranial and spinal cord MRI studies of 226 case participants from four separate Australian regions were reviewed. MRI sequences were classified according to anatomical location, slice plane, tissue weighting and use of gadolinium-containing contrast media. Results were compared with the 2003 Consortium of Multiple Sclerosis Centres MRI protocol for the diagnosis of MS. The composition of core cranial MRI sequences performed varied across the 226 scans. Of the studies, 91% included sagittal fluid attenuated inversion recovery (FLAIR) sequences. Cranial axial T2-weighted, axial FLAIR and axial proton density-weighted sequences were performed in 88%, 60% and 16% (respectively) of scans. Only 25% of the studies included a T1-weighted contrast-enhanced sequence. Concordance with the guidelines in all sequences was very low (2). Only a small number of MRI investigations performed included all of the sequences stipulated by consensus guidelines. This is likely due to poor awareness in the imaging community of the guidelines and the rationale behind certain sequences. Radiologists with a sub

  7. Phenylketonuria patients' and their parents' acceptance of the disease: multi-centre study.

    Science.gov (United States)

    Witalis, Ewa; Mikoluc, Bożena; Motkowski, Radoslaw; Szyszko, Justyna; Chrobot, Agnieszka; Didycz, Bozena; Lange, Agata; Mozrzymas, Renata; Milanowski, Andrzej; Nowacka, Maria; Piotrowska-Depta, Mariola; Romanowska, Hanna; Starostecka, Ewa; Wierzba, Jolanta; Skorniewska, Magdalena; Wojcicka-Bartlomiejczyk, Barbara Iwona; Gizewska, Maria

    2016-11-01

    Phenylketonuria (PKU) still poses a therapeutic challenge for patients and medical professionals. The aim of the study was to assess both patients' and their parents' acceptance of the disease. The study included 218 PKU patients and 178 parents of PKU children who were enrolled in the study on the basis of questionnaire data. Regarding attitude towards the disease, our study demonstrated that 63 (28.9 %) PKU patients did not accept the disease. Patients who found accepting the disease difficult, more frequently perceived themselves as inferior/different in comparison with their peers. In total, 36 % of patients did not want their friends to be aware of their condition, while only 18 % of parents believed that their children's peers should not know about their disease. In total, 42 % of parents wanted to talk to other parents of PKU children and only 13 % to a doctor. Only 20 % of patients saw the need to discuss their condition with a doctor. In total, 8 % of children, regardless of age, and 14 % of parents preferred to talk to a psychologist. Our data demonstrated that disease acceptance played an essential role in patients' social integration. The study also indicated the need to overcome communication barriers between patients and their healthy peers and for patients to find the courage to be open about the disease. The importance of support groups for PKU families and the significance of strict cooperation between patients and their families with PKU treatment teams were also revealed.

  8. Low incidence but poor prognosis of complicated coeliac disease: a retrospective multicentre study.

    Science.gov (United States)

    Biagi, Federico; Gobbi, Paolo; Marchese, Alessandra; Borsotti, Edoardo; Zingone, Fabiana; Ciacci, Carolina; Volta, Umberto; Caio, Giacomo; Carroccio, Antonio; Ambrosiano, Giuseppe; Mansueto, Pasquale; Corazza, Gino R

    2014-03-01

    Coeliac disease is a chronic enteropathy characterized by an increased mortality caused by its complications, mainly refractory coeliac disease, small bowel carcinoma and abdominal lymphoma. Aim of the study was to study the epidemiology of complications in patients with coeliac disease. Retrospective multicenter case-control study based on collection of clinical and laboratory data. The incidence of complicated coeliac disease was studied among coeliac patients directly diagnosed in four Italian centres. Patients referred to these centres after a diagnosis of coeliac disease and/or complicated coeliac disease in other hospitals were therefore excluded. Between 1/1999 and 10/2011, 1840 adult coeliac patients were followed up for 7364.3 person-years. Fourteen developed complications. Since five patients died, at the end of the observation period (10/2011), the prevalence of complicated coeliac disease was 9/1835 (1/204, 0.49%, 95% CI 0.2-0.9%). The annual incidence of complicated coeliac disease in the study period was 14/7364 (0.2%, 95% CI 0.1-0.31%). Although complications tend to occur soon after the diagnosis of coeliac disease, Kaplan-Meier curve analysis showed that they can actually occur at any time after the diagnosis of coeliac disease. Complications of coeliac disease in our cohort were quite rare, though characterised by a very high mortality. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  9. Absence of low back pain to demarcate an episode: A prospective multicentre study in primary care

    DEFF Research Database (Denmark)

    Eklund, Erik A; Jensen, Irene; Lohela-Karlsson, Malin

    2016-01-01

    Background: It has been proposed that an episode of low back pain (LBP) be defined as: "a period of pain in the lower back lasting for more than 24 h preceded and followed by a period of at least 1 month without LBP". Previous studies have tested the definition in the general population and in se......Background: It has been proposed that an episode of low back pain (LBP) be defined as: "a period of pain in the lower back lasting for more than 24 h preceded and followed by a period of at least 1 month without LBP". Previous studies have tested the definition in the general population...

  10. WHO multicentre study for the development of growth standards from fetal life to childhood

    DEFF Research Database (Denmark)

    Merialdi, Mario; Widmer, Mariana; Gülmezoglu, Ahmet Metin

    2014-01-01

    backgrounds. The study will select pregnant women of high-middle socioeconomic status with no obvious environmental constraints on growth (adequate nutritional status, non-smoking), and normal pregnancy history with no complications likely to affect fetal growth. The study will be conducted in centres from...... ten developing and industrialized countries: Argentina, Brazil, Democratic Republic of Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand. At each centre, 140 pregnant women will be recruited between 8 + 0 and 12 + 6 weeks of gestation. Subsequently, visits for fetal biometry...

  11. Influence of female bodyweight on IVF outcome: a longitudinal multicentre cohort study of 487 infertile couples

    DEFF Research Database (Denmark)

    Pinborg, A; Gaarslev, C; Hougaard, C O

    2011-01-01

    This study investigated the impact of women's body mass index (BMI) on the outcome after consecutive IVF/intracytoplasmic sperm injection cycles in 487 patients initiating treatment with 5-year follow-up. The total number of cycles was 1417. In total 103 (21.1%) were overweight (BMI 25-29.9 kg...

  12. Hepatitis E virus infection and acute non-traumatic neurological injury: A prospective multicentre study

    NARCIS (Netherlands)

    Dalton, H.R.; Eijk, J.J.J. van; Cintas, P.; Madden, R.G.; Jones, C.; Webb, G.W.; Norton, B.; Pique, J.; Lutgens, S.; Devooght-Johnson, N.; Woolson, K.; Baker, J.; Saunders, M.; Househam, L.; Griffiths, J.; Abravanel, F.; Izopet, J.; Kamar, N.; Alfen, N. van; Engelen, B.G.M. van; Hunter, J.G.; Eijk, A.A. van der; Bendall, R.P.; McLean, B.N.; Jacobs, B.C.

    2017-01-01

    BACKGROUND & AIMS: Hepatitis E virus (HEV) has been associated with a number of neurological syndromes, but causality has not yet been established. The aim of this study was to explore the relationship between HEV and neurological illness by prospective HEV testing of patients presenting with acute

  13. Rehabilitation of traumatic brain injury in Italy: a multi-centred study.

    Science.gov (United States)

    Zampolini, M; Zaccaria, B; Tolli, V; Frustaci, A; Franceschini, M

    2012-01-01

    The aims of this study were to analyse TBI rehabilitation in Italy, identifying the main factors conditioning motor and functional recovery and destination upon discharge of traumatic severe acquired brain injury (sABI) patients who had undergone intensive rehabilitative treatment. An observational prospective study of 863 consecutive patients admitted to 52 Rehabilitation Centres from January 2001 to December 2003. The main cause of trauma was road accidents (79.8%), the mean length of stay was 87.31 ± 77.26 days and 40.4% access to rehabilitation facilities after a month. Pressure sore rates fell from 26.1% to 6.6% during the rehabilitation programme. After discharge 615 patients returned home, whilst 212 were admitted to other health facilities. This study highlights some major criticisms of rehabilitation of TBI. The delay of admission and evitable complications such as pressure sores are correlated to a worse outcome. While LOS causes a problem of cost-effectiveness, the rate of home discharge is prevalent and very high compared with other studies.

  14. National pholcodine consumption and prevalence of IgE-sensitization: a multicentre study

    DEFF Research Database (Denmark)

    Johansson, S G O; Florvaag, E; Oman, H

    2010-01-01

    The aim of this study was to test, on a multinational level, the pholcodine (PHO) hypothesis, i.e. that the consumption of PHO-containing cough mixtures could cause higher prevalence of IgE antibodies to PHO, morphine (MOR) and suxamethonium (SUX). As a consequence the risk of anaphylaxis to neur...

  15. How patients would like to improve medical consultations: insights from a multicentre European study.

    NARCIS (Netherlands)

    Mazzi, M.A.; Rimondini, M.; Boerma, W.G.W.; Zimmermann, C.; Bensing, J.M.

    2016-01-01

    Objective: In a previous qualitative study (GULiVer-I), a series of lay-people derived recommendations (‘tips’) was listed for doctor and patient on ‘How to make medical consultation more effective from the patient’s perspective’. This work (GULiVer-II) aims to find evidence whether these tips can

  16. How patients would like to improve medical consultations : Insights from a multicentre European study

    NARCIS (Netherlands)

    Mazzi, Maria Angela; Rimondini, Michela; Boerma, Wienke G W; Zimmermann, Christa; Bensing, Jozien M|info:eu-repo/dai/nl/068519397

    OBJECTIVE: In a previous qualitative study (GULiVer-I), a series of lay-people derived recommendations ('tips') was listed for doctor and patient on 'How to make medical consultation more effective from the patient's perspective'. This work (GULiVer-II) aims to find evidence whether these tips can

  17. EC multicentre study on small area variations in air quality and health (SAVIAH)

    Energy Technology Data Exchange (ETDEWEB)

    Lebret, E [National Inst. of Public Health and Environmental Protection (Netherlands); Elliott, P [London School of Hygiene and Tropical Medicine (United Kingdom); Briggs, D [Huddersfield Univ. (United Kingdom). Inst. of Environmental and Policy Analysis; Gorynski, P [National Inst. of Hygiene, Warsaw (Poland); Kriz, B [National Inst. of Public Health, Prague (Czech Republic)

    1996-12-31

    SAVIAH is an EC-funded methodological study coordinated by Dr. Paul Elliott at the LSHTM (London School of Hygiene and Tropical Medicine). The project aims to apply, test and evaluate new and emerging methodologies in the fields of epidemiology, geography, air pollution modelling and small area health statistics, and to bring the data together in a consistent geographic framework. The study was carried out in the U.K., The Netherlands, Poland and the Czech Republic, using the example of childhood wheeze and outdoor air pollution. Specific aims of the study were, in each centre, (1) to carry out a questionnaire survey among parents of guardians of around 4000 to 5000 children aged between 7 and 11, (2) to carry out a series of air pollution surveys for NO{sub 2} as a proxy for the complex of traffic-related pollutants, and SO{sub 2} (PL), using a dense network of passive samplers, (3) to build up a detailed Geographical Information System (GIS) for each of the study areas; (4) to construct an air pollution `map` based on the NO{sub 2} and SO{sub 2} measurements and a health `map` based on `map smoothing` techniques and (5) to explore methods to examine relationships between health, pollution, socio-economic and other data. (author)

  18. EC multicentre study on small area variations in air quality and health (SAVIAH)

    Energy Technology Data Exchange (ETDEWEB)

    Lebret, E. [National Inst. of Public Health and Environmental Protection (Netherlands); Elliott, P. [London School of Hygiene and Tropical Medicine (United Kingdom); Briggs, D. [Huddersfield Univ. (United Kingdom). Inst. of Environmental and Policy Analysis; Gorynski, P. [National Inst. of Hygiene, Warsaw (Poland); Kriz, B. [National Inst. of Public Health, Prague (Czech Republic)

    1995-12-31

    SAVIAH is an EC-funded methodological study coordinated by Dr. Paul Elliott at the LSHTM (London School of Hygiene and Tropical Medicine). The project aims to apply, test and evaluate new and emerging methodologies in the fields of epidemiology, geography, air pollution modelling and small area health statistics, and to bring the data together in a consistent geographic framework. The study was carried out in the U.K., The Netherlands, Poland and the Czech Republic, using the example of childhood wheeze and outdoor air pollution. Specific aims of the study were, in each centre, (1) to carry out a questionnaire survey among parents of guardians of around 4000 to 5000 children aged between 7 and 11, (2) to carry out a series of air pollution surveys for NO{sub 2} as a proxy for the complex of traffic-related pollutants, and SO{sub 2} (PL), using a dense network of passive samplers, (3) to build up a detailed Geographical Information System (GIS) for each of the study areas; (4) to construct an air pollution `map` based on the NO{sub 2} and SO{sub 2} measurements and a health `map` based on `map smoothing` techniques and (5) to explore methods to examine relationships between health, pollution, socio-economic and other data. (author)

  19. The incidence of venous thromboembolism in patients with overt hyperthyroidism A retrospective multicentre cohort study

    NARCIS (Netherlands)

    Kootte, Ruud S.; Stuijver, Danka J. F.; Dekkers, Olaf M.; van Zaane, Bregje; Fliers, Eric; Cannegieter, Suzanne C.; Gerdes, Victor E. A.

    2012-01-01

    Hyperthyroidism is associated with several changes in the haemostatic system resulting in a hypercoagulable state. It is uncertain at this stage whether this leads to an increased risk of venous thromboembolism (VIE). The aim of this retrospective cohort study was to determine the risk of VTE in all

  20. Effectiveness of family work interventions on schizophrenia: evidence from a multicentre study in Catalonia.

    Science.gov (United States)

    Tomás, Esther Pousa; Hurtado, Gemma; Noguer, Sílvia; Domènech, Cristina; García, Montse; López, Nuria; Negredo, Maríacruz; Penadés, Rafael; Reinares, María; Serrano, Dolors; Dolz, Montse; Gallo, Pedro

    2012-11-01

    Despite their proven efficacy, family work interventions on families of patients with schizophrenia are not being implemented in routine clinical practice in contexts where expressed emotion levels among caregivers are relatively high. This study aimed to explore the effectiveness of a family work intervention in a Mediterranean environment in Catalonia, Spain. Participants were 23 patients and 35 key relatives in five different clinical settings. The family intervention was provided by 10 trained health care professionals during a nine-month period. A six-month follow-up was also conducted. Statistically significant improvements were found in patients' clinical status, global functioning and social functioning levels, as well as in caregivers' burden of care. These results were maintained during follow-up. This is the first study to explore the effectiveness of family intervention in a high-expressed emotion context in Catalonia. The findings add weight to the growing literature supporting these interventions in different cultural settings.

  1. The use of antidepressants in patients with advanced cancer--results from an international multicentre study.

    Science.gov (United States)

    Janberidze, Elene; Hjermstad, Marianne Jensen; Brunelli, Cinzia; Loge, Jon Håvard; Lie, Hanne Cathrine; Kaasa, Stein; Knudsen, Anne Kari

    2014-10-01

    Depression is common in patients with advanced cancer; however, it is not often recognized and therefore not treated. The aims of this study were to examine the prevalence of the use of antidepressants (ADs) in an international cross-sectional study sample and to identify sociodemographic and medical variables associated with their use. The study was conducted in patients with advanced cancer from 17 centres across eight countries. Healthcare professionals registered patient and disease-related characteristics. A dichotomous score (no/yes) was used to assess the use of ADs other than as adjuvant for pain. Self-report questionnaires from patients were used for the assessment of functioning and symptom intensity. Of 1051 patient records with complete data on ADs, 1048 were included (M:540/F:508, mean age 62 years, standard deviation [SD] 12). The majority were inpatients, and 85% had metastatic disease. The prevalence of AD use was 14%. Multivariate logistic regression analyses showed that younger age (odds ratio [OR] 2.46; confidence interval [CI] 1.32-4.55), female gender (OR 1.59; CI 1.09-2.33), current medication for pain (OR 2.68; CI 1.65-4.33) and presence of three or more co-morbidities (OR 4.74; CI 2.27-9.91) were associated with AD use for reasons other than pain. Disease-related variables (diagnoses, stage, Karnofsky Performance Status and survival) were not associated with the use of ADs. Female gender, younger age, analgesic use and multiple co-morbidities were associated with the use of ADs. However, information is still limited on which variables guide physicians in prescribing AD medication. Further longitudinal studies including details on psychiatric and medication history are needed to improve the identification of patients in need of ADs. Copyright © 2014 John Wiley & Sons, Ltd.

  2. Community and Healthcare Providers' Perspectives on Male Circumcision: A Multi-Centric Qualitative Study in India

    Science.gov (United States)

    Sahay, Seema; Nagarajan, Karikalan; Mehendale, Sanjay; Deb, Sibnath; Gupta, Abhilasha; Bharat, Shalini; Bhatt, Shripad; Kumar, Athokpam Bijesh; Kanthe, Vidisha; Sinha, Anju; Chandhiok, Nomita

    2014-01-01

    Background Although male circumcision (MC) is recommended as an HIV prevention option, the religious, cultural and biomedical dimensions of its feasibility, acceptability and practice in India have not been explored till date. This study explores beliefs, experiences and understanding of the community and healthcare providers (HCPs) about adult MC as an HIV prevention option in India. Methods This qualitative study covered 134 in-depth interviews from Belgaum, Kolkata, Meerut and Mumbai cities of India. Of these, 62 respondents were the members of circumcising (CC)/non-circumcising communities (NCC); including medically and traditionally circumcised men, parents of circumcised children, spouses of circumcised men, and religious clerics. Additionally, 58 registered healthcare providers (RHCPs) such as general and pediatric surgeons, pediatricians, skin and venereal disease specialists, general practitioners, and operation theatre nurses were interviewed. Fourteen traditional circumcisers were also interviewed. The data were coded and analyzed in QSR NUD*IST ver. 6.0. The study has not explored the participants' views about neonatal versus adult circumcision. Results Members of CC/NCC, traditional circumcisers and RCHPs expressed sharp religious sensitivities around the issue of MC. Six themes emerged: Male circumcision as the religious rite; Multiple meanings of MC: MC for ‘religious identity/privilege/sacrifice’ or ‘hygiene’; MC inflicts pain and cost; Medical indications outweigh faith; Hesitation exists in accepting ‘foreign’ evidence supporting MC; and communication is the key for acceptance of MCs. Medical indications could make members of NCC accept MC following appropriate counseling. Majority of the RHCPs demanded local in-country evidence. Conclusion HCPs must educate high-risk groups regarding the preventive and therapeutic role of MC. Communities need to discuss and create new social norms about male circumcision for better societal acceptance

  3. Community and healthcare providers' perspectives on male circumcision: a multi-centric qualitative study in India.

    Directory of Open Access Journals (Sweden)

    Seema Sahay

    Full Text Available Although male circumcision (MC is recommended as an HIV prevention option, the religious, cultural and biomedical dimensions of its feasibility, acceptability and practice in India have not been explored till date. This study explores beliefs, experiences and understanding of the community and healthcare providers (HCPs about adult MC as an HIV prevention option in India.This qualitative study covered 134 in-depth interviews from Belgaum, Kolkata, Meerut and Mumbai cities of India. Of these, 62 respondents were the members of circumcising (CC/non-circumcising communities (NCC; including medically and traditionally circumcised men, parents of circumcised children, spouses of circumcised men, and religious clerics. Additionally, 58 registered healthcare providers (RHCPs such as general and pediatric surgeons, pediatricians, skin and venereal disease specialists, general practitioners, and operation theatre nurses were interviewed. Fourteen traditional circumcisers were also interviewed. The data were coded and analyzed in QSR NUD*IST ver. 6.0. The study has not explored the participants' views about neonatal versus adult circumcision.Members of CC/NCC, traditional circumcisers and RCHPs expressed sharp religious sensitivities around the issue of MC. Six themes emerged: Male circumcision as the religious rite; Multiple meanings of MC: MC for 'religious identity/privilege/sacrifice' or 'hygiene'; MC inflicts pain and cost; Medical indications outweigh faith; Hesitation exists in accepting 'foreign' evidence supporting MC; and communication is the key for acceptance of MCs. Medical indications could make members of NCC accept MC following appropriate counseling. Majority of the RHCPs demanded local in-country evidence.HCPs must educate high-risk groups regarding the preventive and therapeutic role of MC. Communities need to discuss and create new social norms about male circumcision for better societal acceptance especially among the NCC. Feasibility

  4. Autonomic symptoms in idiopathic REM behavior disorder: a multicentre case-control study.

    Science.gov (United States)

    Ferini-Strambi, Luigi; Oertel, Wolfgang; Dauvilliers, Yves; Postuma, Ronald B; Marelli, Sara; Iranzo, Alex; Arnulf, Isabelle; Högl, Birgit; Birgit, Högl; Manni, Raffaele; Miyamoto, Tomoyuki; Fantini, Maria-Livia; Puligheddu, Monica; Jennum, Poul; Sonka, Karel; Santamaria, Joan; Zucconi, Marco; Rancoita, Paola M V; Leu-Semenescu, Smeranda; Frauscher, Birgit; Terzaghi, Michele; Miyamoto, Masayuki; Unger, Marcus; Stiasny-Kolster, Karin; Desautels, Alex; Wolfson, Christina; Pelletier, Amélie; Montplaisir, Jacques

    2014-06-01

    Patients with idiopathic REM sleep behavior disorder (iRBD) are at very high risk of developing neurodegenerative synucleinopathies, which are disorders with prominent autonomic dysfunction. Several studies have documented autonomic dysfunction in iRBD, but large-scale assessment of autonomic symptoms has never been systematically performed. Patients with polysomnography-confirmed iRBD (318 cases) and controls (137 healthy volunteers and 181 sleep center controls with sleep diagnoses other than RBD) were recruited from 13 neurological centers in 10 countries from 2008 to 2011. A validated scale to study the disorders of the autonomic nervous system in Parkinson's disease (PD) patients, the SCOPA-AUT, was administered to all the patients and controls. The SCOPA-AUT consists of 25 items assessing the following domains: gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillomotor, and sexual dysfunction. Our results show that compared to control subjects with a similar overall age and sex distribution, patients with iRBD experience significantly more problems with gastrointestinal, urinary, and cardiovascular functioning. The most prominent differences in severity of autonomic symptoms between our iRBD patients and controls emerged in the gastrointestinal domain. Interestingly, it has been reported that an altered gastrointestinal motility can predate the motor phase of PD. The cardiovascular domain SCOPA-AUT score in our study in iRBD patients was intermediate with respect to the scores reported in PD patients by other authors. Our findings underline the importance of collecting data on autonomic symptoms in iRBD. These data may be used in prospective studies for evaluating the risk of developing neurodegenerative disorders.

  5. ABO and Rh (D group distribution and gene frequency; the first multicentric study in India

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    Amit Agrawal

    2014-01-01

    Full Text Available Background and Objectives: The study was undertaken with the objective to provide data on the ABO and Rh(D blood group distribution and gene frequency across India. Materials and Methods: A total of 10,000 healthy blood donors donating in blood banks situated in five different geographical regions of the country (North, South, East and Center were included in the study. ABO and Rh (D grouping was performed on all these samples. Data on the frequency of ABO and Rh(D blood groups was reported in simple numbers and percentages. Results: The study showed that O was the most common blood group (37.12% in the country closely followed by B at 32.26%, followed by A at 22.88% while AB was the least prevalent group at 7.74%. 94.61% of the donor population was Rh positive and the rest were Rh negative. Regional variations were observed in the distribution. Using the maximum likelihood method, the frequencies of the I A , I B and I O alleles were calculated and tested according to the Hardy Weinberg law of Equilibrium. The calculated gene frequencies are 0.1653 for I A (p, 0.2254 for I B (q and 0.6093 for I O (r. In Indian Population, O (r records the highest value followed by B (q and A (p; O > B > A. Conclusion: The study provides information about the relative distribution of various alleles in the Indian population both on a pan-India basis as well as region-wise. This vital information may be helpful in planning for future health challenges, particularly planning with regards to blood transfusion services.

  6. Multicentre study of treatment outcomes in Australian adolescents and young adults commencing dialysis.

    Science.gov (United States)

    Krischock, Leah; Kennedy, Sean E; Hayen, Andrew

    2017-12-01

    The aim of the study is to improve the understanding of outcomes and complications of dialysis in adolescents and young adults (AYA) to inform decisions about dialysis modality in this patient population. Registry data on Australian AYA aged 13 to 20 years who commenced dialysis between 1/1/2000 and 31/12/2013 were retrieved from the Australia and New Zealand Dialysis and Transplantation Registry and analyzed to determine associations between demographic characteristics, dialysis modality and outcomes. During the study period 300 AYA commenced dialysis at a median age of 17.2 years (IQR 15.6 to 18.6 years). Haemodialysis (HD) was the initial dialysis modality in 201 patients (67%). No significant differences between AYA receiving HD and peritoneal dialysis (PD) were noted in patient gender, age, race, primary renal disease, treating centre type, remoteness of residential area, lateness of referral or period of study. Mean haemoglobin levels were lower in the HD group (P = 0.005) and significantly fewer HD patients attended school full time compared to patients managed on PD (P = 0.002 first year; P = 0.05 second year). Dialysis modality choice does not appear to be influenced by patient characteristics nor dialysis outcomes. Future research is required to examine the reasons that HD is preferred over PD and to determine the optimal method of dialysis for this age group. © 2016 Asian Pacific Society of Nephrology.

  7. The diagnostic and therapeutic impact of MRI: an observational multi-centre study

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    Hollingworth, William; Todd, Christopher J.; Bell, Matthew I.; Arafat, Qais; Girling, Simon; Karia, Kanti R.; Dixon, Adrian K

    2000-11-01

    AIM: To provide information about the diagnostic and therapeutic impact of magnetic resonance imaging (MRI) and to compare the findings across diagnostic groups. MATERIALS AND METHODS: A prospective, observational study of 2017 consecutive referrals for MRI of the head, spine or knee at four imaging centres. Clinicians completed questionnaires before MRI stating initial diagnoses, diagnostic confidence and treatment plans. After imaging, a second questionnaire evaluated clinicians' revised diagnosis and treatment plans in the light of imaging findings. Patients were grouped into nine diagnostic categories for analysis. Comparison between pre- and post-imaging was used to assess the diagnostic and therapeutic impact of MRI. RESULTS: In seven of nine diagnostic groups MRI findings were associated with a diagnostic impact. Diagnoses were revised or discarded following normal MR findings and diagnostic confidence was increased by confirmative MR findings. There was no statistically significant diagnostic impact for suspected pituitary or cerebello-pontine angle lesions. In five of nine diagnostic groups (knee meniscus, knee ligament, multiple sclerosis, lumbar and cervical spine) MRI findings had a clear impact on treatment plans. CONCLUSION: This study demonstrates that in most diagnostic categories, MRI influences diagnosis and treatment. However, experimental studies are needed to prove that these diagnostic and therapeutic impacts lead to improved health. Hollingworth (2000)

  8. The diagnostic and therapeutic impact of MRI: an observational multi-centre study

    International Nuclear Information System (INIS)

    Hollingworth, William; Todd, Christopher J.; Bell, Matthew I.; Arafat, Qais; Girling, Simon; Karia, Kanti R.; Dixon, Adrian K.

    2000-01-01

    AIM: To provide information about the diagnostic and therapeutic impact of magnetic resonance imaging (MRI) and to compare the findings across diagnostic groups. MATERIALS AND METHODS: A prospective, observational study of 2017 consecutive referrals for MRI of the head, spine or knee at four imaging centres. Clinicians completed questionnaires before MRI stating initial diagnoses, diagnostic confidence and treatment plans. After imaging, a second questionnaire evaluated clinicians' revised diagnosis and treatment plans in the light of imaging findings. Patients were grouped into nine diagnostic categories for analysis. Comparison between pre- and post-imaging was used to assess the diagnostic and therapeutic impact of MRI. RESULTS: In seven of nine diagnostic groups MRI findings were associated with a diagnostic impact. Diagnoses were revised or discarded following normal MR findings and diagnostic confidence was increased by confirmative MR findings. There was no statistically significant diagnostic impact for suspected pituitary or cerebello-pontine angle lesions. In five of nine diagnostic groups (knee meniscus, knee ligament, multiple sclerosis, lumbar and cervical spine) MRI findings had a clear impact on treatment plans. CONCLUSION: This study demonstrates that in most diagnostic categories, MRI influences diagnosis and treatment. However, experimental studies are needed to prove that these diagnostic and therapeutic impacts lead to improved health. Hollingworth (2000)

  9. A multi-centre study of interactional style in nurse specialist- and physician-led Rheumatology clinics in the UK.

    Science.gov (United States)

    Vinall-Collier, Karen; Madill, Anna; Firth, Jill

    2016-07-01

    Nurse-led care is well established in Rheumatology in the UK and provides follow-up care to people with inflammatory arthritis including treatment, monitoring, patient education and psychosocial support. The aim of this study is to compare and contrast interactional style with patients in physician-led and nurse-led Rheumatology clinics. A multi-centre mixed methods approach was adopted. Nine UK Rheumatology out-patient clinics were observed and audio-recorded May 2009-April 2010. Eighteen practitioners agreed to participate in clinic audio-recordings, researcher observations, and note-taking. Of 9 nurse specialists, 8 were female and 5 of 9 physicians were female. Eight practitioners in each group took part in audio-recorded post-clinic interviews. All patients on the clinic list for those practitioners were invited to participate and 107 were consented and observed. In the nurse specialist cohort 46% were female; 71% had a diagnosis of Rheumatoid Arthritis (RA). The physician cohort comprised 31% female; 40% with RA and 16% unconfirmed diagnosis. Nineteen (18%) of the patients observed were approached for an audio-recorded telephone interview and 15 participated (4 male, 11 female). Forty-four nurse specialist and 63 physician consultations with patients were recorded. Roter's Interactional Analysis System (RIAS) was used to code this data. Thirty-one semi-structured interviews were conducted (16 practitioner, 15 patients) within 24h of observed consultations and were analyzed using thematic analysis. RIAS results illuminated differences between practitioners that can be classified as 'socio-emotional' versus 'task-focussed'. Specifically, nurse specialists and their patients engaged significantly more in the socio-emotional activity of 'building a relationship'. Across practitioners, the greatest proportion of 'patient initiations' were in 'giving medical information' and reflected what patients wanted the practitioner to know rather than giving insight into

  10. 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.

  11. Cerebrospinal fluid biomarker supported diagnosis of Creutzfeldt–Jakob disease and rapid dementias: a longitudinal multicentre study over 10 years

    Science.gov (United States)

    Sanchez-Juan, Pascual; Gawinecka, Joanna; Green, Alison; Ladogana, Anna; Pocchiari, Maurizio; Sanchez-Valle, Raquel; Mitrova, Eva; Sklaviadis, Theodor; Kulczycki, Jerzy; Slivarichova, Dana; Saiz, Albert; Calero, Miguel; Knight, Richard; Aguzzi, Adriano; Laplanche, Jean-Louis; Peoc’h, Katell; Schelzke, Gabi; Karch, Andre; van Duijn, Cornelia M.; Zerr, Inga

    2012-01-01

    To date, cerebrospinal fluid analysis, particularly protein 14-3-3 testing, presents an important approach in the identification of Creutzfeldt–Jakob disease cases. However, one special point of criticism of 14-3-3 testing is the specificity in the differential diagnosis of rapid dementia. The constant observation of increased cerebrospinal fluid referrals in the national surveillance centres over the last years raises the concern of declining specificity due to higher number of cerebrospinal fluid tests performed in various neurological conditions. Within the framework of a European Community supported longitudinal multicentre study (‘cerebrospinal fluid markers’) we analysed the spectrum of rapid progressive dementia diagnoses, their potential influence on 14-3-3 specificity as well as results of other dementia markers (tau, phosphorylated tau and amyloid-β1–42) and evaluated the specificity of 14-3-3 in Creutzfeldt–Jakob disease diagnosis for the years 1998–2008. A total of 29 022 cerebrospinal fluid samples were analysed for 14-3-3 protein and other cerebrospinal fluid dementia markers in patients with rapid dementia and suspected Creutzfeldt–Jakob disease in the participating centres. In 10 731 patients a definite diagnosis could be obtained. Protein 14-3-3 specificity was analysed for Creutzfeldt–Jakob disease with respect to increasing cerebrospinal fluid tests per year and spectrum of differential diagnosis. Ring trials were performed to ensure the comparability between centres during the reported time period. Protein 14-3-3 test specificity remained high and stable in the diagnosis of Creutzfeldt–Jakob disease during the observed time period across centres (total specificity 92%; when compared with patients with definite diagnoses only: specificity 90%). However, test specificity varied with respect to differential diagnosis. A high 14-3-3 specificity was obtained in differentiation to other neurodegenerative diseases (95–97%) and non

  12. Cerebrospinal fluid biomarker supported diagnosis of Creutzfeldt-Jakob disease and rapid dementias: a longitudinal multicentre study over 10 years.

    Science.gov (United States)

    Stoeck, Katharina; Sanchez-Juan, Pascual; Gawinecka, Joanna; Green, Alison; Ladogana, Anna; Pocchiari, Maurizio; Sanchez-Valle, Raquel; Mitrova, Eva; Sklaviadis, Theodor; Kulczycki, Jerzy; Slivarichova, Dana; Saiz, Albert; Calero, Miguel; Knight, Richard; Aguzzi, Adriano; Laplanche, Jean-Louis; Peoc'h, Katell; Schelzke, Gabi; Karch, Andre; van Duijn, Cornelia M; Zerr, Inga

    2012-10-01

    To date, cerebrospinal fluid analysis, particularly protein 14-3-3 testing, presents an important approach in the identification of Creutzfeldt-Jakob disease cases. However, one special point of criticism of 14-3-3 testing is the specificity in the differential diagnosis of rapid dementia. The constant observation of increased cerebrospinal fluid referrals in the national surveillance centres over the last years raises the concern of declining specificity due to higher number of cerebrospinal fluid tests performed in various neurological conditions. Within the framework of a European Community supported longitudinal multicentre study ('cerebrospinal fluid markers') we analysed the spectrum of rapid progressive dementia diagnoses, their potential influence on 14-3-3 specificity as well as results of other dementia markers (tau, phosphorylated tau and amyloid-β(1-42)) and evaluated the specificity of 14-3-3 in Creutzfeldt-Jakob disease diagnosis for the years 1998-2008. A total of 29 022 cerebrospinal fluid samples were analysed for 14-3-3 protein and other cerebrospinal fluid dementia markers in patients with rapid dementia and suspected Creutzfeldt-Jakob disease in the participating centres. In 10 731 patients a definite diagnosis could be obtained. Protein 14-3-3 specificity was analysed for Creutzfeldt-Jakob disease with respect to increasing cerebrospinal fluid tests per year and spectrum of differential diagnosis. Ring trials were performed to ensure the comparability between centres during the reported time period. Protein 14-3-3 test specificity remained high and stable in the diagnosis of Creutzfeldt-Jakob disease during the observed time period across centres (total specificity 92%; when compared with patients with definite diagnoses only: specificity 90%). However, test specificity varied with respect to differential diagnosis. A high 14-3-3 specificity was obtained in differentiation to other neurodegenerative diseases (95-97%) and non

  13. 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.

  14. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

    Directory of Open Access Journals (Sweden)

    Fayers Peter

    2010-09-01

    Full Text Available Abstract Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis. Aim 1 To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2 To determine patient health outcomes over time and principle cost drivers [Study Phase 2]. The study objectives are as follows. 1 To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1 in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2 To conduct patient focus group discussions at each of these (Phase 1 to determine care received. 3 To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2. 4 To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2. 5 To undertake document

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

    DEFF Research Database (Denmark)

    Kjaergaard, H.; Olsen, J.; Ottesen, Bent Smedegaard

    2008-01-01

    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......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......: The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix

  16. A multicentric observational study to evaluate the role of homoeopathic therapy in vitiligo

    Directory of Open Access Journals (Sweden)

    P S Chakraborty

    2015-01-01

    Results: The changes in the mean VSS at intervals of every 6 months was found to be statistically significant. Homoeopathic treatment was found to be useful in relieving vitiligo in varying degrees in 126 patients, out of which 4 (2.94% cases showed marked improvement, 15 (11.03% cases showed moderate improvement, 77 (56.62% cases showed mild improvement, and 30 patients although improved, fell in the category of not significant improvement group (below 25% improvement. Ten homoeopathic medicines were found useful in the study of which Sulphur (n = 27, Arsenicum album (n = 19, Phosphorus (n = 19, and Lycopodium clavatum (n = 10 were the most commonly indicated and useful medicines.

  17. Review of Van earthquakes form an orthopaedic perspective: a multicentre retrospective study.

    Science.gov (United States)

    Guner, Savas; Guner, Sukriye Ilkay; Isik, Yasemin; Gormeli, Gokay; Kalender, Ali Murat; Turktas, Ugur; Gokalp, Mehmet Ata; Gozen, Abdurrahim; Isik, Mustafa; Ozkan, Sezai; Turkozu, Tulin; Karadas, Sevdegul; Ceylan, Mehmet Fethi; Ediz, Levent; Bulut, Mehmet; Gunes, Yusuf; Gormeli, Ayse; Erturk, Cemil; Eseoglu, Metehan; Dursun, Recep

    2013-01-01

    This is a descriptive analysis, of victims of Turkey's October 23, 2011 and November 21, 2011 Van earthquakes. The goal of this study is investigated the injury profile of the both earthquakes in relation to musculoskeletal trauma. We retrospectively reviewed medical records of 3,965 patients admitted to in seven hospitals. A large share of these injuries were soft tissue injuries, followed by fractures, crush injuries, crush syndromes, nerve injuries, vascular injuries, compartment syndrome and joint dislocations. A total of 73 crush injuries were diagnosed and 31 of them were developed compartment syndrome. The patients with closed undisplaced fractures were treated with casting braces. For closed unstable fractures with good skin and soft-tissue conditions, open reduction and internal fixation was performed. All patients with open fracture had an external fixator applied after adequate debridement. Thirty one of 40 patients with compartment syndrome were treated by fasciotomy. For twelve of them, amputation was necessary. The most common procedure performed was debridement, followed by open reduction and internal fixation and closed reduction-casting, respectively. The results of this study may provide the basis for future development of strategy to optimise attempts at rescue and plan treatment of survivors with musculoskeletal injuries after earthquakes.

  18. [A multicentre comparative study of the ESPrit and the Nucleus 22].

    Science.gov (United States)

    Berger, K; Bagus, H; Michels, H; Roth, J; Voss, B; Klenzner, T

    2006-05-01

    Cochlear implant recipients often report additional difficulty in comprehension of speech in noisy conditions and of softly spoken speech. The aim of this clinical study was to evaluate and compare the performance advantages offered by the ear level ESPrit 3G for experienced Nucleus Mini 22 cochlear implantees. Twenty-eight German-speaking implanted subjects, who had had experience with either the Spectra 22 or the ESPrit 22 for at least 6 months, were evaluated with their current processor and the ESPrit 3G (on microphone, M, and whisper, W, settings) following a 4-week trial. Freiburger monosyllabic words (FMW) were used at soft and conversational levels in quiet conditions and Oldenburger sentences (OLSA) were used in noisy conditions to compare performance. Subjective impressions of sound quality and user aspects were evaluated and combined with data from 31 English-speaking subjects from a parallel study. In comparison to the previously worn processor, statistically significantly superior performance (pESPrit 3G was preferred by 86% of subjects (51/59). The ESPrit 3G for Nucleus 22 users has the potential to further improve speech understanding in quiet conditions at soft intensity levels and also in noisy conditions at conversational levels relative to the currently worn speech processor, the Spectra 22 or the ESPrit 22, for the majority of subjects. Subjectively, together with the improvement in sound quality, the majority of subjects also reported improved ease of use and wearer comfort.

  19. Stigma experienced by patients with severe mental disorders: A nationwide multicentric study from India.

    Science.gov (United States)

    Grover, Sandeep; Avasthi, Ajit; Singh, Aakanksha; Dan, Amitava; Neogi, Rajarshi; Kaur, Darpan; Lakdawala, Bhavesh; Rozatkar, Abhijit R; Nebhinani, Naresh; Patra, Suravi; Sivashankar, Priya; Subramanyam, Alka A; Tripathi, Adarsh; Gania, Ab Majid; Singh, Gurvinder Pal; Behere, Prakash

    2017-11-01

    This study aimed to evaluate the stigma and its correlates among patients with severe mental disorders. Patients with diagnosis of schizophrenia (N = 707), bipolar disorder (N = 344) and recurrent depressive disorder (N = 352) currently in clinical remission from 14 participating centres were assessed on Internalized Stigma of Mental Illness Scale (ISMIS). Patients with diagnosis of schizophrenia experienced higher level of alienation, sterotype endorsement, discrimination experience and total stigma when compared to patients with bipolar disorder and recurrent depressive disorder. Patients with bipolar disorder experienced higher stigma than those with recurrent depressive disorder in the domain of stigma resistance only. Overall compared to affective disorder groups, higher proportion of patients with schizophrenia reported stigma in all the domains of ISMIS. In general in all the 3 diagnostic groups' stigma was associated with shorter duration of illness, shorter duration of treatment and younger age of onset. To conclude, this study suggests that compared to affective disorder, patients with schizophrenia experience higher self stigma. Higher level of stigma is experienced during the early phase of illness. Stigma intervention programs must focus on patients during the initial phase of illness in order to reduce the negative consequences of stigma. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Coerced hospital admission and symptom change--a prospective observational multi-centre study.

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    Thomas W Kallert

    Full Text Available INTRODUCTION: Coerced admission to psychiatric hospitals, defined by legal status or patient's subjective experience, is common. Evidence on clinical outcomes however is limited. This study aimed to assess symptom change over a three month period following coerced admission and identify patient characteristics associated with outcomes. METHOD: At study sites in 11 European countries consecutive legally involuntary patients and patients with a legally voluntary admission who however felt coerced, were recruited and assessed by independent researchers within the first week after admission. Symptoms were assessed on the Brief Psychiatric Rating Scale. Patients were re-assessed after one and three months. RESULTS: The total sample consisted of 2326 legally coerced patients and 764 patients with a legally voluntary admission who felt coerced. Symptom levels significantly improved over time. In a multivariable analysis, higher baseline symptoms, being unemployed, living alone, repeated hospitalisation, being legally a voluntary patient but feeling coerced, and being initially less satisfied with treatment were all associated with less symptom improvement after one month and, other than initial treatment satisfaction, also after three months. The diagnostic group was not linked with outcomes. DISCUSSION: On average patients show significant but limited symptom improvements after coerced hospital admission, possibly reflecting the severity of the underlying illnesses. Social factors, but not the psychiatric diagnosis, appear important predictors of outcomes. Legally voluntary patients who feel coerced may have a poorer prognosis than legally involuntary patients and deserve attention in research and clinical practice.

  1. Prevalence of maternal anaemia and its predictors: a multi-centre study.

    Science.gov (United States)

    Barroso, Filipa; Allard, Shubha; Kahan, Brennan C; Connolly, Catriona; Smethurst, Heather; Choo, Louise; Khan, Khalid; Stanworth, Simon

    2011-11-01

    To investigate the prevalence, predictors, and management of anaemia in pregnancy. A multi centre study across 11 maternity units in the UK. Data were collected over a two week study period in 2008 on maternal history, haemoglobin (Hb) and ferritin concentrations, iron therapy during pregnancy and in the postpartum period. Logistic regression models were used to explore factors associated with anaemia during pregnancy. Main outcomes included anaemia, defined as Hbanaemia by 32 weeks gestation included young maternal age (odds ratio 1.96, 95% CI 1.38-2.79), non-white ethnic origin (odds ratios varied 1.37-2.89 depending on ethnic origin) and increasing parity (odds ratio 1.24, 95% CI 1.08-1.41). Of women who had postnatal Hb levels checked, 30% (309/1031) were anaemic and, depending on centre, 16% to 86% of these received iron therapy. Anaemia was reported in nearly one in four women in the antenatal period, and nearly one in three of the women who had a postpartum Hb checked. Despite national guidelines, there was considerable variation in administration of iron including low utilisation of parenteral iron therapy. Future research needs to focus on the consequences of iron deficiency anaemia for maternal and infant health outcomes and effectiveness of implementation strategies to reduce anaemia. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  2. The Usher lifestyle survey: maintaining independence: a multi-centre study.

    Science.gov (United States)

    Damen, Godelieve W J A; Krabbe, Paul F M; Kilsby, M; Mylanus, Emmanuel A M

    2005-12-01

    Patients with Usher syndrome face a special set of challenges in order to maintain their independence when their sight and hearing worsen. Three different types of Usher (I, II and III) are distinguished by differences in onset, progression and severity of hearing loss, and by the presence or absence of balance problems. In this study 93 Usher patients from seven European countries filled out a questionnaire on maintaining independence (60 patients type I, 25 patients type II, four patients type III and four patients type unknown). Results of Usher type I and II patients are presented. Following the Nordic definition of maintaining independence in deaf-blindness, three domains are investigated: access to information, communication and mobility. Research variables in this study are: age and type of Usher, considered hearing loss- and the number of retinitis pigmentosa-related sight problems. Usher type I patients tend to need more help than Usher type II patients and the amount of help that they need grows when patients get older or when considered hearing loss worsens. No patterns in results were seen for the number of retinitis pigmentosa related sight problems.

  3. Urea cycle disorders in Spain: an observational, cross-sectional and multicentric study of 104 cases.

    Science.gov (United States)

    Martín-Hernández, Elena; Aldámiz-Echevarría, Luis; Castejón-Ponce, Esperanza; Pedrón-Giner, Consuelo; Couce, María Luz; Serrano-Nieto, Juliana; Pintos-Morell, Guillem; Bélanger-Quintana, Amaya; Martínez-Pardo, Mercedes; García-Silva, María Teresa; Quijada-Fraile, Pilar; Vitoria-Miñana, Isidro; Dalmau, Jaime; Lama-More, Rosa A; Bueno-Delgado, María Amor; Del Toro-Riera, Mirella; García-Jiménez, Inmaculada; Sierra-Córcoles, Concepción; Ruiz-Pons, Mónica; Peña-Quintana, Luis J; Vives-Piñera, Inmaculada; Moráis, Ana; Balmaseda-Serrano, Elena; Meavilla, Silvia; Sanjurjo-Crespo, Pablo; Pérez-Cerdá, Celia

    2014-11-30

    Advances in the diagnosis and treatment of urea cycle disorders (UCDs) have led to a higher survival rate. The purpose of this study is to describe the characteristics of patients with urea cycle disorders in Spain. Observational, cross-sectional and multicenter study. Clinical, biochemical and genetic data were collected from patients with UCDs, treated in the metabolic diseases centers in Spain between February 2012 and February 2013, covering the entire Spanish population. Heterozygous mothers of patients with OTC deficiency were only included if they were on treatment due to being symptomatic or having biochemistry abnormalities. 104 patients from 98 families were included. Ornithine transcarbamylase deficiency was the most frequent condition (64.4%) (61.2% female) followed by type 1 citrullinemia (21.1%) and argininosuccinic aciduria (9.6%). Only 13 patients (12.5%) were diagnosed in a pre-symptomatic state. 63% of the cases presented with type intoxication encephalopathy. The median ammonia level at onset was 298 μmol/L (169-615). The genotype of 75 patients is known, with 18 new mutations having been described. During the data collection period four patients died, three of them in the early days of life. The median current age is 9.96 years (5.29-18), with 25 patients over 18 years of age. Anthropometric data, expressed as median and z-score for the Spanish population is shown. 52.5% of the cases present neurological sequelae, which have been linked to the type of disease, neonatal onset, hepatic failure at diagnosis and ammonia values at diagnosis. 93 patients are following a protein restrictive diet, 0.84 g/kg/day (0.67-1.10), 50 are receiving essential amino acid supplements, 0.25 g/kg/day (0.20-0.45), 58 arginine, 156 mg/kg/day (109-305) and 45 citrulline, 150 mg/kg/day (105-199). 65 patients are being treated with drugs: 4 with sodium benzoate, 50 with sodium phenylbutyrate, 10 with both drugs and 1 with carglumic acid. Studies like this make it

  4. Social disadvantages associated with myasthenia gravis and its treatment: a multicentre cross-sectional study.

    Science.gov (United States)

    Nagane, Yuriko; Murai, Hiroyuki; Imai, Tomihiro; Yamamoto, Daisuke; Tsuda, Emiko; Minami, Naoya; Suzuki, Yasushi; Kanai, Tetsuya; Uzawa, Akiyuki; Kawaguchi, Naoki; Masuda, Masayuki; Konno, Shingo; Suzuki, Hidekazu; Aoki, Masashi; Utsugisawa, Kimiaki

    2017-02-23

    To clarify the social disadvantages associated with myasthenia gravis (MG) and examine associations with its disease and treatment. Cross-sectional study. We evaluated 917 consecutive cases of established MG seen at 13 neurological centres in Japan over a short duration. All patients completed a questionnaire on social disadvantages resulting from MG and its treatment and a 15-item MG-specific quality of life scale at study entry. Clinical severity at the worst condition was graded according to the MG Foundation of America classification, and that at the current condition was determined according to the quantitative MG score and MG composite. Maximum dose and duration of dose ≥20 mg/day of oral prednisolone during the disease course were obtained from the patients' medical records. Achievement of the treatment target (minimal manifestation status with prednisolone at ≤5 mg/day) was determined at 1, 2 and 4 years after starting treatment and at study entry. We found that 27.2% of the patients had experienced unemployment, 4.1% had been unwillingly transferred and 35.9% had experienced a decrease in income, 47.1% of whom reported that the decrease was ≥50% of their previous total income. In addition, 49.0% of the patients reported feeling reduced social positivity. Factors promoting social disadvantages were severity of illness, dose and duration of prednisolone, long-term treatment, and a depressive state and change in appearance after treatment with oral steroids. Early achievement of the treatment target was a major inhibiting factor. Patients with MG often experience unemployment, unwilling job transfers and a decrease in income. In addition, many patients report feeling reduced social positivity. To inhibit the social disadvantages associated with MG and its treatment, greater focus needs to be placed on helping patients with MG resume a normal lifestyle as soon as possible by achieving the treatment target. Published by the BMJ Publishing Group

  5. High-risk papillomavirus infection among women living with human Immunodeficiency virus: Brazilian multicentric study.

    Science.gov (United States)

    Miranda, Angelica E; Silveira, Mariangela F; Travassos, Ana G; Tenório, Teresinha; Val, Isabel C C; Lannoy, Leonor; Mattos Junior, Hortensio S; Carvalho, Newton S

    2017-12-01

    Cervical cancer is an important health issue in Latin America. Although HPV infections can have spontaneous clearance, persistence of high-risk (HR) HPV is a risk factor for cervical cancer among women and it is even higher in HIV-infected women. To determine the prevalence of HR-HPV and risk factors among HIV-infected women attending reference services for HIV/AIDS in different regions of Brazil. Cross-sectional study conducted among HIV-infected women attended at referral care centers for HIV/AIDS in nine states of Brazil. Women from 18 to 49 years that accept to participate and were not pregnant at the time of the approach were recruited for the study. The HPV screening was realized using qPCR in closed system, in vitro Diagnostic, COBAS ® -HPV Roche. The cytology results were available by the Bethesda System. A total of 802(89.1%) from the selected women agreed to participate in the study. Median age was 39(Inter quartile range [IQR34-46]) years and median education was 9(IQR6-11) years. General prevalence of HR-HPV was 28.4%(228/802). HPV-16 prevalence rate was 8.1%(65/802), HPV-18 was 3.7%(30/802) and other types of HR-HPV were 23.6% (189/802). Risk factors for HR-HPV infection in the multivariate logistic regression analysis were: age ranging from 18 to 34 years (OR = 1.43[95%CI:1.18-1.75]), illicit drugs use (OR = 1.61[95%CI:1.10-2.42]) and abnormal cervical cytology (OR = 1.56[95%CI:1.34-1.81]). Results showed a prevalence rate of 28.4% of HR-HPV infection in women living with HIV in Brazil. These infections were significantly associated with having less than 35 years old, illicit drug use and abnormal cervical cytology. © 2017 Wiley Periodicals, Inc.

  6. The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol].

    Science.gov (United States)

    Leach, Matthew J; Segal, Leonie; Esterman, Adrian; Armour, Caroline; McDermott, Robyn; Fountaine, Tim

    2013-12-20

    Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of two different, evidence-based models of care (compared to usual care) on clinical quality, patient and provider experience, and cost. The DCP uses a pragmatic, cluster randomised controlled trial design. Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate. Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months: (a) control group (usual care); (b) Intervention 1 (which tests improvements that could be made within the current funding model, facilitated through the use of an online chronic disease management network); or (c) Intervention 2 (which includes the same components as Intervention 1, as well as altered funding to support voluntary patient registration with their practice, incentive payments and a care facilitator). Adult patients who attend the enrolled practices and have established (≥12 month's duration) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate. Multiple outcomes will be studied, including changes in glycosylated haemoglobin (primary outcome), changes in other biochemical and clinical metrics, incidence of diabetes-related complications, quality of life, clinical depression, success of tailored care, patient and practitioner satisfaction, and budget sustainability. This project responds to a need for robust

  7. Modelling attending physician productivity in the emergency department: a multicentre study.

    Science.gov (United States)

    Joseph, Joshua W; Davis, Samuel; Wilker, Elissa H; Wong, Matthew L; Litvak, Ori; Traub, Stephen J; Nathanson, Larry A; Sanchez, Leon D

    2018-05-01

    Emergency physician productivity, often defined as new patients evaluated per hour, is essential to planning clinical operations. Prior research in this area considered this a static quantity; however, our group's study of resident physicians demonstrated significant decreases in hourly productivity throughout shifts. We now examine attending physicians' productivity to determine if it is also dynamic. This is a retrospective cohort study, conducted from 2014 to 2016 across three community hospitals in the north-eastern USA, with different schedules and coverage. Timestamps of all patient encounters were automatically logged by the sites' electronic health record. Generalised estimating equations were constructed to predict productivity in terms of new patients per shift hour. 207 169 patients were seen by 64 physicians over 2 years, comprising 9822 physician shifts. Physicians saw an average of 15.0 (SD 4.7), 20.9 (SD 6.4) and 13.2 (SD 3.8) patients per shift at the three sites, with 2.97 (SD 0.22), 2.95 (SD 0.24) and 2.17 (SD 0.09) in the first hour. Across all sites, physicians saw significantly fewer new patients after the first hour, with more gradual decreases subsequently. Additional patient arrivals were associated with greater productivity; however, this attenuates substantially late in the shift. The presence of other physicians was also associated with slightly decreased productivity. Physician productivity over a single shift follows a predictable pattern that decreases significantly on an hourly basis, even if there are new patients to be seen. Estimating productivity as a simple average substantially underestimates physicians' capacity early in a shift and overestimates it later. This pattern of productivity should be factored into hospitals' staffing plans, with shifts aligned to start with the greatest volumes of patient arrivals. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved

  8. DNA fingerprinting and antimicrobial susceptibility pattern of clinical and environmental Acinetobacter baumannii isolates: a multicentre study.

    Science.gov (United States)

    Salimizand, Himen; Menbari, Shaho; Ramazanzadeh, Rashid; Khonsha, Masomeh; Saleh Vahedi, Mohammad

    2016-08-01

    The aims of this study were to establish antibiotic profile and the molecular epidemiology of Acinetobacter baumannii isolates, with considering the effectiveness of control infection measures across three hospitals in the Kurdistan, west part of Iran. Fifty-four A. baumannii isolates were collected from patients and environmental specimens. Antibiotic susceptibility patterns (Antibio-type) were evaluated for 17 different antibiotics and MIC for imipenem was done. Isolates were assessed for the presence of metallo-beta-lactamases (MBLs), class 1 and 2 integrons, and integrated gene cassettes and blaOXA-likefamilies genes. Repetitive-sequence-based PCR (REP-PCR) was done for analysing clonality and relativeness of isolates (REP-type). Antibiotic susceptibility patterns distinguished 11 distinct Antibio-types and REP-PCR showed three clusters with 20 subclusters, mostly belonged to two clonal subgroups, A1 and B1. blaOXA-51 and blaOXA-23 were detected in 100% (54/54) and 52% (28/54), respectively, while blaOXA-24-like and blaOXA-58 were not present in isolates. MBLs were not detected, but, however, high rate of imipenem resistance was observed (52%). MIC90 of imipenem was 16 mg/ml. Class 1 integrons were detected in 11% (6/54) of isolates followed by 24% (13/54) of class 2. Both classes of integron genes were detected in 15% (8/54) of isolates. Integrated gene cassettes were in low level (11% of class 1 harboring isolates). Two arrays of gene cassettes were revealed, dfrA5-like and dfrA17-aadA5. Infection control surveillance should be considered as a serious manner, even the superficial eradication of hospital acquired pathogens. MBL genes were not induced carbapenem resistance in studied hospital settings, but blaOXA-51 & 23 contributed in imipenem resistant. Integrons had a little share in resistance of A. baumannii isolates.

  9. Nurses' knowledge and attitudes regarding major immobility complications among bedridden patients: A prospective multicentre study.

    Science.gov (United States)

    Li, Zhen; Zhou, Xinmei; Cao, Jing; Li, Zheng; Wan, Xia; Li, Jiaqian; Jiao, Jing; Liu, Ge; Liu, Ying; Li, Fangfang; Song, Baoyun; Jin, Jingfen; Liu, Yilan; Wen, Xianxiu; Cheng, Shouzhen; Wu, Xinjuan

    2018-05-01

    To gain insight into nurses' knowledge and attitudes regarding major immobility complications (pressure ulcers, pneumonia, deep vein thrombosis and urinary tract infections) and explore the correlation of nurses' knowledge and attitudes with the incidence of these complications. Immobility complications have adverse consequences, and effective management requires appropriate knowledge, attitudes and skills. Evidence about nurses' knowledge and attitudes regarding immobility complications is lacking. Cross-sectional study. A total of 3,903 nurses and 21,333 bedridden patients from 25 hospitals in China were surveyed. Nurses' knowledge and attitudes regarding major immobility complications were assessed using researcher-developed questionnaires. The content validity, reliability and internal consistency of the questionnaires were validated through expert review and a pilot study. The incidence of major immobility complications among bedridden patients from selected wards was surveyed by trained investigators. Correlations between knowledge, attitudes and the incidence of major immobility complications were evaluated with multilevel regression models. Mean knowledge scores were 64.07% for pressure ulcers, 72.92% for deep vein thrombosis, 76.54% for pneumonia and 83.30% for urinary tract infections. Mean attitude scores for these complications were 86.25%, 84.31%, 85.00% and 84.53%, respectively. Knowledge and attitude scores were significantly higher among nurses with older age, longer employment duration, higher education level, previous training experience and those working in tertiary hospitals or critical care units. Nurses' knowledge about pressure ulcers was negatively related to the incidence of pressure ulcers, and attitude towards pneumonia was negatively correlated with the incidence of pneumonia. Clinical nurses have relatively positive attitudes but inadequate knowledge regarding major immobility complications. Improved knowledge and attitudes regarding

  10. A multicentre matched case control study of risk factors for Preeclampsia in healthy women in Pakistan

    Directory of Open Access Journals (Sweden)

    Qadri Zeeshan

    2010-04-01

    Full Text Available Abstract Background Preeclampsia is one of the leading causes of maternal and perinatal morbidity and mortality world-wide. The risk for developing preeclampsia varies depending on the underlying mechanism. Because the disorder is heterogeneous, the pathogenesis can differ in women with various risk factors. Understanding these mechanisms of disease responsible for preeclampsia as well as risk assessment is still a major challenge. The aim of this study was to determine the risk factors associated with preeclampsia, in healthy women in maternity hospitals of Karachi and Rawalpindi. Methods We conducted a hospital based matched case-control study to assess the factors associated with preeclampsia in Karachi and Rawalpindi, from January 2006 to December 2007. 131 hospital-reported cases of PE and 262 controls without history of preeclampsia were enrolled within 3 days of delivery. Cases and controls were matched on the hospital, day of delivery and parity. Potential risk factors for preeclampsia were ascertained during in-person postpartum interviews using a structured questionnaire and by medical record abstraction. Conditional logistic regression was used to estimate matched odds ratios (ORs and 95% confidence intervals (95% CIs. Results In multivariate analysis, women having a family history of hypertension (adjusted OR 2.06, 95% CI; 1.27-3.35, gestational diabetes (adjusted OR 6.57, 95% CI; 1.94 -22.25, pre-gestational diabetes (adjusted OR 7.36, 95% CI; 1.37-33.66 and mental stress during pregnancy (adjusted OR 1.32; 95% CI; 1.19-1.46, for each 5 unit increase in Perceived stress scale score were at increased risk of preeclampsia. However, high body mass index, maternal age, urinary tract infection, use of condoms prior to index pregnancy and sociodemographic factors were not associated with higher risk of having preeclampsia. Conclusions Development of preeclampsia was associated with gestational diabetes, pregestational diabetes, family

  11. Age in antiretroviral therapy programmes in South Africa: a multi-centre observational cohort study

    Science.gov (United States)

    Cornell, Morna; Johnson, Leigh F; Schomaker, Michael; Tanser, Frank; Maskew, Mhairi; Wood, Robin; Prozesky, Hans; Giddy, Janet; Stinson, Kathryn; Egger, Matthias; Boulle, Andrew; Myer, Landon

    2015-01-01

    Background As access to antiretroviral therapy (ART) expands, increasing numbers of older patients will start treatment and require specialised long-term care. However the impact of age in ART programs in resource-constrained settings is poorly understood. South Africa has the second largest population of older (≥50 years) people in sub-Saharan Africa. The HIV epidemic is also ageing rapidly and the country has one of the highest HIV population prevalences worldwide. This study explored the effect of age on mortality on ART in South Africa and whether this effect was mediated by baseline immunologic status. Methods IeDEA-SA is a regional collaboration which combines routine observational data from large ART programmes across Southern Africa. This study was a retrospective cohort analysis of adults starting ART from 2004-2013 in six large South African cohorts: two primary care clinics, three hospitals and a large rural cohort. The primary outcome was mortality; secondary outcomes were loss to follow-up (LTF), immunologic and virologic responses. Patients' vital status was ascertained through linkage to the National Population Register. Inverse probability weighting was used to correct mortality for LTF. Mortality was estimated using Cox's proportional hazards and competing risks regression. The interaction between baseline CD4+ cell count and age was tested. Immunologic responses were graphed by age and duration on ART. Findings 83 566 patients were followed for 174 640 patient-years. Patients were predominantly female, especially in the younger age groups: 81% (18 819/23 258) of patients 16-29 years and 66% (12 812/19 372) of those aged 30-34. Mortality increased with age in a dose response, mediated by baseline immunologic status. Patients with CD4 counts <50 cells/μL were a particularly high risk group, comprising 14% of all older patients starting ART. The percentage of older patients enrolling increased with successive calendar years from 6% (290/4 999) in

  12. Prevalence, predictors and outcome of hypofibrinogenaemia in trauma: a multicentre observational study.

    Science.gov (United States)

    Hagemo, Jostein S; Stanworth, Simon; Juffermans, Nicole P; Brohi, Karim; Cohen, Mitchell; Johansson, Pär I; Røislien, Jo; Eken, Torsten; Næss, Paal A; Gaarder, Christine

    2014-03-26

    Exsanguination due to trauma-induced coagulopathy is a continuing challenge in emergency trauma care. Fibrinogen is a crucial factor for haemostatic competence, and may be the factor that reaches critically low levels first. Early fibrinogen substitution is advocated by a number of authors. Little evidence exists regarding the indications for fibrinogen supplementation in the acute phase. This study aims to estimate the prevalence of hypofibrinogenaemia in a multi-center trauma population, and to explore how initial fibrinogen concentration relates to outcome. Also, factors contributing to low fibrinogen levels are identified. Patients arriving in hospital less than 180 minutes post-injury requiring full trauma team activation in four different centers were included in the study. Time from injury, patient demographics, injury severity scores (ISS) and 28 days outcome status were recorded. Initial blood samples for coagulation and blood gas were analyzed. Generalized additive regression, piecewise linear regression, and multiple linear regression models were used for data analyses. Out of 1,133 patients we identified a fibrinogen concentration ≤1.5g/L in 8.2%, and <2 g/L in 19.2%. A non-linear relationship between fibrinogen concentration and mortality was detected in the generalized additive and piecewise linear regression models. In the piecewise linear regression model we identified a breakpoint for optimal fibrinogen concentration at 2.29 g/L (95% confidence interval (CI): 1.93 to 2.64). Below this value the odds of death by 28 days was reduced by a factor of 0.08 (95% CI: 0.03 to 0.20) for every unit increase in fibrinogen concentration. Low age, male gender, lengthened time from injury, low base excess and high ISS were unique contributors to low fibrinogen concentrations on arrival. Hypofibrinogenaemia is common in trauma and strongly associated with poor outcome. Below an estimated critical fibrinogen concentration value of 2.29 g/L a dramatic increase in

  13. Physical Activity through Sustainable Transport Approaches (PASTA): a study protocol for a multicentre project.

    Science.gov (United States)

    Gerike, Regine; de Nazelle, Audrey; Nieuwenhuijsen, Mark; Panis, Luc Int; Anaya, Esther; Avila-Palencia, Ione; Boschetti, Florinda; Brand, Christian; Cole-Hunter, Tom; Dons, Evi; Eriksson, Ulf; Gaupp-Berghausen, Mailin; Kahlmeier, Sonja; Laeremans, Michelle; Mueller, Natalie; Orjuela, Juan Pablo; Racioppi, Francesca; Raser, Elisabeth; Rojas-Rueda, David; Schweizer, Christian; Standaert, Arnout; Uhlmann, Tina; Wegener, Sandra; Götschi, Thomas

    2016-01-07

    Only one-third of the European population meets the minimum recommended levels of physical activity (PA). Physical inactivity is a major risk factor for non-communicable diseases. Walking and cycling for transport (active mobility, AM) are well suited to provide regular PA. The European research project Physical Activity through Sustainable Transport Approaches (PASTA) pursues the following aims: (1) to investigate correlates and interrelations of AM, PA, air pollution and crash risk; (2) to evaluate the effectiveness of selected interventions to promote AM; (3) to improve health impact assessment (HIA) of AM; (4) to foster the exchange between the disciplines of public health and transport planning, and between research and practice. PASTA pursues a mixed-method and multilevel approach that is consistently applied in seven case study cities. Determinants of AM and the evaluation of measures to increase AM are investigated through a large scale longitudinal survey, with overall 14,000 respondents participating in Antwerp, Barcelona, London, Örebro, Rome, Vienna and Zurich. Contextual factors are systematically gathered in each city. PASTA generates empirical findings to improve HIA for AM, for example, with estimates of crash risks, factors on AM-PA substitution and carbon emissions savings from mode shifts. Findings from PASTA will inform WHO's online Health Economic Assessment Tool on the health benefits from cycling and/or walking. The study's wide scope, the combination of qualitative and quantitative methods and health and transport methods, the innovative survey design, the general and city-specific analyses, and the transdisciplinary composition of the consortium and the wider network of partners promise highly relevant insights for research and practice. Ethics approval has been obtained by the local ethics committees in the countries where the work is being conducted, and sent to the European Commission before the start of the survey. The PASTA website

  14. Single-course specific immunotherapy with mixed pollen allergoids: results of a multi-centre study.

    Science.gov (United States)

    Drachenberg, K J; Pröll, S; Urban, E; Woroniecki, S R

    2003-01-01

    A short-term immunotherapy vaccine for the treatment of pollen allergy has been developed utilising L-tyrosine adsorbed allergoids. The reduced number of injections could provide advantages over long-term therapy schedules. This would improve compliance and support application of specific immunotherapy (SIT) to a greater extent. We report a multicenter study to evaluate the efficacy and safety of this treatment in a clinical practice setting. Patients (n = 1808) with a diagnosis of sensitivities to various pollens and symptoms of allergic asthma and/or allergic rhinitis and/or allergic conjunctivitis were selected. The vaccine formulation was made up according to individual sensitivities and contained L-tyrosine adsorbed allergoids. The patients were treated with a 3-injection initial course followed by a 3-injection maintenance course. Efficacy was measured by consumption of symptomatic anti-allergic medication compared with that in the previous season and by physician assessment using a 5-point scale. All adverse events were recorded. Efficacy was demonstrated by a considerable decrease in regular and frequent use of medication compared with that in the previous season (p allergoid/L-tyrosine vaccine in a clinical practice setting provided a high level of efficacy with a low incidence of mainly mild adverse events.

  15. Radiation exposure of medical staff from interventional x-ray procedures: a multicentre study

    International Nuclear Information System (INIS)

    Haeusler, Uwe; Brix, Gunnar; Czarwinski, Renate

    2009-01-01

    The purpose of this study was to analyse the radiation exposure of medical staff from interventional x-ray procedures. Partial-body dose measurements were performed with thermoluminescent dosimeters (TLD) in 39 physicians and nine assistants conducting 73 interventional procedures of nine different types in 14 hospitals in Germany. Fluoroscopy time and the dose-area product (DAP) were recorded too. The median (maximum) equivalent body dose per procedure was 16 (2,500) μSv for an unshielded person; the partial-body dose per procedure was 2.8 (240) μSv to the eye lens, 4.1 (730) μSv to the thyroid, 44 (1,800) μSv to one of the feet and 75 (13,000) μSv to one of the hands. A weak correlation between fluoroscopy time or DAP and the mean TLD dose was observed. Generally, the doses were within an acceptable range from a radiation hygiene point of view. However, relatively high exposures were measured to the hand in some cases and could cause a partial-body dose above the annual dose limit of 500 mSv. Thus, the use of finger dosimeters is strongly recommended. (orig.)

  16. Strategic verbal rehearsal in adolescents with mild intellectual disabilities: A multi-centre European study.

    Science.gov (United States)

    Poloczek, Sebastian; Henry, Lucy A; Danielson, Henrik; Büttner, Gerhard; Mähler, Claudia; Messer, David J; Schuchardt, Kirsten; Molen, Mariët J van der

    2016-11-01

    There is a long-held view that verbal short-term memory problems of individuals with intellectual disabilities (ID) might be due to a deficit in verbal rehearsal. However, the evidence is inconclusive and word length effects as indicator of rehearsal have been criticised. The aim of this multi-site European study was to investigate verbal rehearsal in adolescents with mild ID (n=90) and a comparison group of typically developing children matched individually for mental age (MA, n=90). The investigation involved: (1) a word length experiment with non-verbal recall using pointing and (2) 'self-paced' inspection times to infer whether verbal strategies were utilised when memorising a set of pictorial items. The word length effect on recall did not interact with group, suggesting that adolescents with ID and MA comparisons used similar verbal strategies, possibly phonological recoding of picture names. The inspection time data suggested that high span individuals in both groups used verbal labelling or single item rehearsal on more demanding lists, as long named items had longer inspection times. The findings suggest that verbal strategy use is not specifically impaired in adolescents with mild ID and is mental age appropriate, supporting a developmental perspective. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Patient dose in interventional radiology: a multicentre study of the most frequent procedures in France

    International Nuclear Information System (INIS)

    Etard, Cecile; Bigand, Emeline; Salvat, Cecile; Vidal, Vincent; Beregi, Jean Paul; Hornbeck, Amaury; Greffier, Joel

    2017-01-01

    A national retrospective survey on patient doses was performed by the French Society of Medical physicists to assess reference levels (RLs) in interventional radiology as required by the European Directive 2013/59/Euratom. Fifteen interventional procedures in neuroradiology, vascular radiology and osteoarticular procedures were analysed. Kerma area product (KAP), fluoroscopy time (FT), reference air kerma and number of images were recorded for 10 to 30 patients per procedure. RLs were calculated as the 3rd quartiles of the distributions. Results on 4600 procedures from 36 departments confirmed the large variability in patient dose for the same procedure. RLs were proposed for the four dosimetric estimators and the 15 procedures. RLs in terms of KAP and FT were 90 Gm.cm 2 and 11 mins for cerebral angiography, 35 Gy.cm 2 and 16 mins for biliary drainage, 75 Gy.cm 2 and 6 mins for lower limbs arteriography and 70 Gy.cm 2 and 11 mins for vertebroplasty. For these four procedures, RLs were defined according to the complexity of the procedure. For all the procedures, the results were lower than most of those already published. This study reports RLs in interventional radiology based on a national survey. Continual evolution of practices and technologies requires regular updates of RLs. (orig.)

  18. Patient dose in interventional radiology: a multicentre study of the most frequent procedures in France

    Energy Technology Data Exchange (ETDEWEB)

    Etard, Cecile [Institut de Radioprotection et de Surete Nucleaire, Fontenay-aux-Roses (France); French Society of Medical Physicists (SFPM), Paris (France); Bigand, Emeline [French Society of Medical Physicists (SFPM), Paris (France); La Timone University Hospital, Department of Radiology, Marseille Cedex (France); Salvat, Cecile [French Society of Medical Physicists (SFPM), Paris (France); Lariboisiere Hospital, Department of Medical Physics and Radiation Protection, Paris (France); Vidal, Vincent [La Timone University Hospital, Department of Radiology, Marseille Cedex (France); French Society of Radiology (SFR) - Interventional Radiology Federation (FRI), Paris (France); Beregi, Jean Paul [French Society of Radiology (SFR) - Interventional Radiology Federation (FRI), Paris (France); Nimes University Hospital, Medical Imaging Group Nimes, Department of Radiology, Nimes (France); Hornbeck, Amaury [French Society of Medical Physicists (SFPM), Paris (France); Trousseau University Hospital, Department of Pediatric Radiology, Paris (France); Greffier, Joel [French Society of Medical Physicists (SFPM), Paris (France); Nimes University Hospital, Medical Imaging Group Nimes, Department of Radiology, Nimes (France)

    2017-10-15

    A national retrospective survey on patient doses was performed by the French Society of Medical physicists to assess reference levels (RLs) in interventional radiology as required by the European Directive 2013/59/Euratom. Fifteen interventional procedures in neuroradiology, vascular radiology and osteoarticular procedures were analysed. Kerma area product (KAP), fluoroscopy time (FT), reference air kerma and number of images were recorded for 10 to 30 patients per procedure. RLs were calculated as the 3rd quartiles of the distributions. Results on 4600 procedures from 36 departments confirmed the large variability in patient dose for the same procedure. RLs were proposed for the four dosimetric estimators and the 15 procedures. RLs in terms of KAP and FT were 90 Gm.cm{sup 2} and 11 mins for cerebral angiography, 35 Gy.cm{sup 2} and 16 mins for biliary drainage, 75 Gy.cm{sup 2} and 6 mins for lower limbs arteriography and 70 Gy.cm{sup 2} and 11 mins for vertebroplasty. For these four procedures, RLs were defined according to the complexity of the procedure. For all the procedures, the results were lower than most of those already published. This study reports RLs in interventional radiology based on a national survey. Continual evolution of practices and technologies requires regular updates of RLs. (orig.)

  19. [Quality assessment for preanalytical phase in clinical laboratory: a multicentric study].

    Science.gov (United States)

    Salinas, M; López-Garrigós, M; Yago, M; Ortuño, M; Carratala, A; Aguado, C; Díaz, J; Rodriguez-Borja, E; Chinchilla, V; Esteban, A; Laíz, B; Lorente, M Á; Uris, J

    2011-01-01

    To show the number of preanalytical sample errors in seven laboratories attending seven health departments of Valencian Community (Spain). Cross-sectional study of the number of preanlytical errors in samples obtained in primary care centers. An error is defined as a rejected specimen: any blood or urine sample, which cannot be successfully tested as it does not meet the acceptability criteria of the laboratory or if the sample is not received. We collected preanalytical errors from the tests requested for hematology, coagulation, chemistry, and urine samples. Registers were collected and indicators calculated automatically through a data warehouse and OLAP cubes software. Large differences in the results of preanalytical errors were observed between health departments. The highest percentage of errors occurred in coagulation samples, followed by urine, hematology and biochemistry. With regard to the type of error, the largest proportion of errors was due to failures of process. The high incidence of preanalytical errors and variability between health departments suggests that there is a need to standardize the drawing practice. Copyright © 2010 SECA. Published by Elsevier Espana. All rights reserved.

  20. The proximity between hallucination and delusion dimensions: An observational, analytic, cross-sectional, multicentre study

    Directory of Open Access Journals (Sweden)

    Diogo Telles-correia

    2016-11-01

    Full Text Available 5.In the current psychiatric classifications, hallucinations (mainly auditory hallucinations are one of the fundamental criteria for establishing a schizophrenia diagnosis or any of the related psychotic disorder’s diagnoses.6.Throughout the history of Psychiatry the conceptual proximity between delusions and hallucinations in the psychiatric patient was maintained until the end of the XIX century,with several supporters during the XX century. Their frontier was not yet definitely defined in terms of Descriptive Psychopathology, and much less so in terms of biochemical and anatomical models.7.In this article we aimed to analyse the dimensions of both hallucinations and delusions in a sample of patients with schizophrenia and schizoaffective disorder. We also intend to find the determinants of the main dimensions of hallucinations.8.One hundred patients with schizophrenia or schizoaffective disorder from both the outpatient and inpatient units of the Psychiatry Department of Hospital of Santa Maria and the Centro Hospitalar Psiquiátrico de Lisboa were assessed by means of the Psychotic Symptom Rating Scales (PSYRATS. 9.In this study we found an empirical based model, where the main dimensions of hallucinations are determined by the central dimensions of delusions. 10.Keywords: Psyrats, Hallucinations, Psychopathology, Psychosis, delusions

  1. Qualitative and quantitative revaluation of specific learning disabilities: a multicentric study.

    Science.gov (United States)

    Operto, Francesca F; Mazza, Roberta; Buttiglione, Maura; Craig, Francesco; Frolli, Alessandro; Pisano, Simone; Margari, Lucia; Coppola, Giangennaro

    2018-04-12

    Specific learning disabilities are disorders that affect the instrumental skills of academic learning, leaving intact the general intellectual functioning. It is possible to distinguish: dyslexia, dysorthography, dysgraphia, and dyscalculia. The diagnosis is made according to DSMV. The aim of this study is to evaluate the implementation of Law N° 170 following a diagnosis of specific learning disabilities in children and their evolution over time. The sample under examination consists of 75 children, 56 males and 18 females aged 7,8 to 16 years, with a diagnosis of specific learning disabilities; a revaluation was carried outthrough the use of standardized instruments according to age and school attended. A twopart questionnaire was proposed: the first part turned to the parents/carers of the child and the second part turned to the boy himself. The improvement parameter has been linked, through a statistical analysis of univarianza with intelligence quotient, age, application of the law 10 October 2010 n 170, rehabilitative paths and attending afterschool program. Most of the guys are followed at school by the application of the law 170 and, outside school, by attending speech and neuropsychological therapy and after school. Going to investigate the actual use of the measures put in place by the school, it is evident a partial and incomplete application of Law 170. The most suitable measures for these children are pedagogical measures in order to make them integrate with the group class and strengthen their capacities through specific measures provided by a specific legislative decree.

  2. Treatment of imported malaria in adults: a multicentre study in France.

    Science.gov (United States)

    Ranque, S; Marchou, B; Malvy, D; Adehossi, E; Laganier, R; Tissot-Dupont, H; Lotte, A; Dydymsky, S; Durant, J; Stahl, J-P; Bosseray, A; Gaillat, J; Sotto, A; Cazorla, C; Ragneau, J-M; Brouqui, P; Delmont, J

    2005-10-01

    Data about anti-malarial drugs prescription practices in Europe and the safety of imported malaria treatments are scanty. In 1999, a French consensus development conference published guidelines for the prevention and treatment of imported P. falciparum malaria. The impact of these guidelines has not been evaluated. To investigate the impact of these guidelines on the prescription of anti-malarials, and to evaluate the incidence of acute drug events (ADEs) leading to discontinuation of treatment. Cross-sectional survey. Members of the medical staff in 14 French infectious and tropical disease wards completed a standardized form for each patient treated for imported malaria in 2001. A propensity score matching technique was used to estimate the risk of ADEs leading to discontinuation of the regimen. In the 474 patients studied, quinine was the first-line anti-malarial most often prescribed. Only 3% of patients received halofantrine. Mefloquine was associated with a RR of 4.9 (95%CI 3.2-7.4, p guidelines have been taken into account. Mefloquine was associated with a substantial risk of discontinuing the treatment because of ADEs. This is a serious limitation for the use of mefloquine in the treatment of out-patients with imported malaria.

  3. 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.

  4. Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial.

    Science.gov (United States)

    Norman, Jane Elizabeth; Marlow, Neil; Messow, Claudia-Martina; Shennan, Andrew; Bennett, Phillip R; Thornton, Steven; Robson, Stephen C; McConnachie, Alex; Petrou, Stavros; Sebire, Neil J; Lavender, Tina; Whyte, Sonia; Norrie, John

    2016-05-21

    Progesterone administration has been shown to reduce the risk of preterm birth and neonatal morbidity in women at high risk, but there is uncertainty about longer term effects on the child. We did a double-blind, randomised, placebo-controlled trial of vaginal progesterone, 200 mg daily taken from 22-24 to 34 weeks of gestation, on pregnancy and infant outcomes in women at risk of preterm birth (because of previous spontaneous birth at ≤34 weeks and 0 days of gestation, or a cervical length ≤25 mm, or because of a positive fetal fibronectin test combined with other clinical risk factors for preterm birth [any one of a history in a previous pregnancy of preterm birth, second trimester loss, preterm premature fetal membrane rupture, or a history of a cervical procedure to treat abnormal smears]). The objective of the study was to determine whether vaginal progesterone prophylaxis given to reduce the risk of preterm birth affects neonatal and childhood outcomes. We defined three primary outcomes: fetal death or birth before 34 weeks and 0 days gestation (obstetric), a composite of death, brain injury, or bronchopulmonary dysplasia (neonatal), and a standardised cognitive score at 2 years of age (childhood), imputing values for deaths. Randomisation was done through a web portal, with participants, investigators, and others involved in giving the intervention, assessing outcomes, or analysing data masked to treatment allocation until the end of the study. Analysis was by intention to treat. This trial is registered at ISRCTN.com, number ISRCTN14568373. Between Feb 2, 2009, and April 12, 2013, we randomly assigned 1228 women to the placebo group (n=610) and the progesterone group (n=618). In the placebo group, data from 597, 587, and 439 women or babies were available for analysis of obstetric, neonatal, and childhood outcomes, respectively; in the progesterone group the corresponding numbers were 600, 589, and 430. After correction for multiple outcomes

  5. Age in antiretroviral therapy programmes in South Africa: a retrospective, multicentre, observational cohort study.

    Science.gov (United States)

    Cornell, Morna; Johnson, Leigh F; Schomaker, Michael; Tanser, Frank; Maskew, Mhairi; Wood, Robin; Prozesky, Hans; Giddy, Janet; Stinson, Kathryn; Egger, Matthias; Boulle, Andrew; Myer, Landon

    2015-09-01

    As access to antiretroviral therapy (ART) expands, increasing numbers of older patients will start treatment and need specialised long-term care. However, the effect of age in ART programmes in resource-constrained settings is poorly understood. The HIV epidemic is ageing rapidly and South Africa has one of the highest HIV population prevalences worldwide. We explored the effect of age on mortality of patients on ART in South Africa and whether this effect is mediated by baseline immunological status. In this retrospective cohort analysis, we studied HIV-positive patients aged 16-80 years who started ART for the first time in six large South African cohorts of the International Epidemiologic Databases to Evaluate AIDS-Southern Africa collaboration, in KwaZulu-Natal, Gauteng, and Western Cape (two primary care clinics, three hospitals, and a large rural cohort). The primary outcome was mortality. We ascertained patients' vital status through linkage to the National Population Register. We used inverse probability weighting to correct mortality for loss to follow-up. We estimated mortality using Cox's proportional hazards and competing risks regression. We tested the interaction between baseline CD4 cell count and age. Between Jan 1, 2004, and Dec 31, 2013, 84,078 eligible adults started ART. Of these, we followed up 83,566 patients for 174,640 patient-years. 8% (1817 of 23,258) of patients aged 16-29 years died compared with 19% (93 of 492) of patients aged 65 years or older. The age adjusted mortality hazard ratio was 2·52 (95% CI 2·01-3·17) for people aged 65 years or older compared with those 16-29 years of age. In patients starting ART with a CD4 count of less than 50 cells per μL, the adjusted mortality hazard ratio was 2·52 (2·04-3·11) for people aged 50 years or older compared with those 16-39 years old. Mortality was highest in patients with CD4 counts of less than 50 cells per μL, and 15% (1103 of 7295) of all patients aged 50 years or older

  6. Reference values of urinary trans,trans-muconic acid: Italian Multicentric Study.

    Science.gov (United States)

    Aprea, C; Sciarra, G; Bozzi, N; Pagliantini, M; Perico, A; Bavazzano, P; Leandri, A; Carrieri, M; Scapellato, M L; Bettinelli, M; Bartolucci, G B

    2008-08-01

    This article reports the results of a study, conducted in the framework of the scientific activities of the Italian Society for Reference Values, aimed at defining reference values of urinary trans,trans-muconic acid (t,t-MA) in the general population not occupationally exposed to benzene. t,t-MA concentrations detected in 376 subjects of the resident population in three areas of Italy, two in central (Florence and southern Tuscany) and one in northern Italy (Padua), by three laboratories, compared by repeated interlaboratory controls, showed an interval of 14.4-225.0 microg/L (5th-95th percentile) and a geometric mean of 52.5 microg/L. The concentrations measured were influenced by tobacco smoking in a statistically significant way: Geometric mean concentrations were 44.8 microg/L and 76.1 microg/Ll in nonsmokers (264 subjects) and smokers (112 subjects), respectively. In the nonsmoking population, a significant influence of gender was found when concentrations were corrected for urinary creatinine, geometric mean concentrations being 36.7 microg/g creatinine in males (128 subjects) and 44.7 microg/g creatinine in females (136 subjects). The place of residence of subjects did not seem to influence urinary excretion of the metabolite, although personal inhalation exposure to benzene over a 24-h period showed slightly higher concentrations in Padua and Florence (geometric means of 6.5 microg/m(3) and 6.6 microg/m(3), respectively) than in southern Tuscany (geometric mean of 3.9 microg/m(3)). Concentration of t,t-MA in urine samples collected at the end of personal air sampling showed little relationship to personal inhalation exposure to benzene, confirming the importance of other factors in determining excretion of t,t-MA when concentrations in personal air samples are very low.

  7. Bullying and Victimization in Overweight and Obese Outpatient Children and Adolescents: An Italian Multicentric Study.

    Directory of Open Access Journals (Sweden)

    Dario Bacchini

    Full Text Available Being overweight or obese is one of the most common reasons that children and adolescents are teased at school. We carried out a study in order to investigate: i the relation between weight status and school bullying and ii the relation between weight status categories and types of victimization and bullying in an outpatient sample of Italian children and adolescents with different degrees of overweight from minimal overweight up to severe obesity.Nine-hundred-forty-seven outpatient children and adolescents (age range 6.0-14.0 years were recruited in 14 hospitals distributed over the country of Italy. The participants were classified as normal-weight (N = 129, overweight (N = 126, moderately obese (N = 568, and severely obese (N = 124. The nature and extent of verbal, physical and relational bullying and victimization were assessed with an adapted version of the revised Olweus bully-victim questionnaire. Each participant was coded as bully, victim, bully-victim, or not involved.Normal-weight and overweight participants were less involved in bullying than obese participants; severely obese males were more involved in the double role of bully and victim. Severely obese children and adolescents suffered not only from verbal victimization but also from physical victimization and exclusion from group activities. Weight status categories were not directly related to bullying behaviour; however severely obese males perpetrated more bullying behaviour compared to severely obese females.Obesity and bullying among children and adolescents are of ongoing concern worldwide and may be closely related. Common strategies of intervention are needed to cope with these two social health challenges.

  8. Occupational and environmental risk factors for chronic rhinosinusitis in China: a multicentre cross-sectional study.

    Science.gov (United States)

    Gao, Wen-Xiang; Ou, Chun-Quan; Fang, Shu-Bin; Sun, Yue-Qi; Zhang, Hua; Cheng, Lei; Wang, Yan-Jun; Zhu, Dong-Dong; Lv, Wei; Liu, Shi-Xi; Li, P Z; Xu, Geng; Shi, Jianbo; Fu, Qing-Ling

    2016-05-17

    Chronic rhinosinusitis (CRS) is defined as a condition of inflammation in the paranasal sinus mucosa persisting for more than 12 weeks. We previously reported that the prevalence of CRS was about 8 % in China. Here, we aim to investigate the occupational and environmental risk factors associated with CRS. Data were collected from seven Chinese cities: Urumqi, Changchun, Beijing, Wuhan, Chengdu, Huaian and Guangzhou. CRS was diagnosed according to the European Position Paper on Rhinosinusitis and Nasal Polyps (EP(3)OS) document. Participants were asked to complete a standardized questionnaire, which was developed by the Global Allergy and Asthma European Network (GA(2)LEN) project and covered sociodemographic characteristics, CRS-related symptoms and occupational and environmental exposures. We evaluated the association between CRS and various occupational and environmental factors using odds ratios (ORs) and 95 % confidence intervals (95 % CIs). The total study population consisted of 10,633 subjects, 850 (7.99 %) of whom were defined as having CRS according to the EP(3)OS criteria. We found that there were significant associations between occupational and environmental factors and CRS. Specifically, having a clearance-related job, occupational exposure to dust, occupational exposure to poisonous gas, a pet at home or carpet at home or at the workplace were risk factors for CRS. Additionally, the method used to keep warm in winter, the duration of time spent using air conditioning in summer and the frequency of exposure to mouldy or damp environments were significantly different in subjects with and without CRS. Our data showed that some occupational and environmental exposures are strongly associated with CRS, which aids in understanding the epidemiology of CRS.

  9. Suboptimal management of central nervous system infections in children: a multi-centre retrospective study

    Directory of Open Access Journals (Sweden)

    Kelly Christine

    2012-09-01

    Full Text Available Abstract Objective We aimed to audit the regional management of central nervous system (CNS infection in children. Methods The study was undertaken in five district general hospitals and one tertiary paediatric hospital in the Mersey region of the UK. Children admitted to hospital with a suspected CNS infection over a three month period were identified. Children were aged between 4 weeks and 16 years old. Details were recorded from the case notes and electronic records. We measured the appropriateness of management pathways as outlined by national and local guidelines. Results Sixty-five children were identified with a median age of 6 months (range 1 month to 15 years. Ten had a CNS infection: 4 aseptic meningitis, 3 purulent meningitis, 3 encephalitis [2 with herpes simplex virus (HSV type 1]. A lumbar puncture (LP was attempted in 50 (77% cases but only 43 had cerebrospinal fluid (CSF available for analysis. Of these 24 (57% had a complete standard set of tests performed. Fifty eight (89% received a third generation cephalosporin. Seventeen (26% also received aciclovir with no obvious indication in 9 (53%. Only 11 (65% of those receiving aciclovir had CSF herpes virus PCR. Seventeen had cranial imaging and it was the first management step in 14. Treatment lengths of both antibiotics and aciclovir were highly variable: one child with HSV encephalitis was only treated with aciclovir for 7 days. Conclusions The clinical management of children with suspected CNS infections across the Mersey region is heterogeneous and often sub-optimal, particularly for the investigation and treatment of viral encephalitis. National guidelines for the management of viral encephalitis are needed.

  10. Phenotype and natural history of elderly onset inflammatory bowel disease: a multicentre, case-control study.

    Science.gov (United States)

    Mañosa, M; Calafat, M; de Francisco, R; García, C; Casanova, M J; Huelín, P; Calvo, M; Tosca, J; Fernández-Salazar, L; Arajol, C; Zabana, Y; Bastida, G; Hinojosa, J; Márquez, L; Barreiro-de-Acosta, M; Calvet, X; Monfort, D; Gómez-Garcia, M R; Rodríguez, E; Huguet, J M; Rojas-Feria, M; Hervias, D; Atienza, R; Busquets, D; Zapata, E; Dueñas, C; Charro, M; Martínez-Cerezo, F J; Plaza, R; Vázquez, J M; Gisbert, J P; Cañete, F; Cabré, E; Domènech, E

    2018-03-01

    Onset during old age has been reported in upto 10% of total cases of inflammatory bowel disease (IBD). To evaluate phenotypic characteristics and the use of therapeutic resources in patients with elderly onset IBD. Case-control study including all those patients diagnosed with IBD over the age of 60 years since 2000 who were followed-up for >12 months, identified from the IBD databases. Elderly onset cases were compared with IBD patients aged 18 to 40 years at diagnosis, matched by year of diagnosis, gender and type of IBD (adult-onset). One thousand three hundred and seventy-four elderly onset and 1374 adult-onset cases were included (62% ulcerative colitis (UC), 38% Crohn's disease (CD)). Among UC patients, elderly onset cases had a lower proportion of extensive disease (33% vs 39%; P < 0.0001). In CD, elderly onset cases showed an increased rate of stenosing pattern (24% vs 13%; P < 0.0001) and exclusive colonic location (28% vs 16%; P < 0.0001), whereas penetrating pattern (12% vs 19%; P < 0.0001) was significantly less frequent. Regarding the use of therapeutic resources, there was a significantly lower use of corticosteroids (P < 0.0001), immunosuppressants (P < 0.0001) and anti-TNFs agents (P < 0.0001) in elderly onset cases. Regarding surgery, we found a significantly higher surgery rate among elderly onset UC cases (8.3% vs 5.1%; P < 0.009). Finally, elderly onset cases were characterised by a higher rate of hospitalisations (66% vs 49%; P < 0.0001) and neoplasms (14% vs 0.5%; P < 0.0001). Elderly onset IBD shows specific characteristics and they are managed differently, with a lower use of immunosuppressants and a higher rate of surgery in UC. © 2018 John Wiley & Sons Ltd.

  11. Malnutrition in Hospitalised Older Adults: A Multicentre Observational Study of Prevalence, Associations and Outcomes.

    Science.gov (United States)

    O'Shea, E; Trawley, S; Manning, E; Barrett, A; Browne, V; Timmons, S

    2017-01-01

    Malnutrition is common in older adults and is associated with high costs and adverse outcomes. The prevalence, predictors and outcomes of malnutrition on admission to hospital are not clear for this population. Prospective Cohort Study. Six hospital sites (five public, one private). In total, 606 older adults aged 70+ were included. All elective and acute admissions to any speciality were eligible. Day-case admissions and those moribund on admission were excluded. Socio-demographic and clinical data, including nutritional status (Mini-Nutritional Assessment - short form), was collected within 36 hours of admission. Outcome data was collected prospectively on length of stay, in-hospital mortality and new institutionalisation. The mean age was 79.7; 51% were female; 29% were elective admissions; 67% were admitted to a medical specialty. Nutrition scores were available for 602/606; 37% had a 'normal' status, 45% were 'at-risk', and 18% were 'malnourished'. Malnutrition was more common in females, acute admissions, older patients and those who were widowed/ separated. Dementia, functional dependency, comorbidity and frailty independently predicted a) malnutrition and b) being at-risk of malnutrition, compared to normal status (p Malnutrition was associated with outcomes including an increased length of stay (p < .001), new institutionalisation (p =<0.001) and in-hospital mortality (p < .001). These findings support the prioritisation of nutritional screening in clinical practice and public health policy, for all patients ≥70 on admission to hospital, and in particular for people with dementia, increased functional dependency and/or multi-morbidity, and those who are frail.

  12. Clinical and microbiological characteristics of peri-implantitis cases: a retrospective multicentre study.

    Science.gov (United States)

    Charalampakis, G; Leonhardt, Å; Rabe, P; Dahlén, G

    2012-09-01

    The aim of this study was to follow patient cases retrospectively in a longitudinal manner from the time of implant placement to the time they were diagnosed with peri-implant disease, and to identify associated clinical and microbiological features of peri-implant disease. A total of 281 patient cases were chosen from the archives of the Oral Microbiological Diagnostic Laboratory, Gothenburg, Sweden, based on bacterial samples taken from diseased implants. A form was designed and filled in separately for each case including data on patient, implant and disease profile. Most cases were severe peri-implantitis cases (91.4%). In 41.3% of the patients, peri-implantitis was developed early, already after having implants in function less than 4 years. The type of implant surface was significantly associated with the time in years implants were in function, before disease was developed (P < 0.05). The microbiological results by both culture and checkerboard analysis, although failed to fully correspond to the severity of the disease in terms of magnitude, proved to show that peri-implantitis is a polymicrobial anaerobic infection with increased number of AGNB (aerobic Gram-negative bacilli) in 18.6% of the patients. Peri-implantitis is a biological complication of implants in function that poses a threat to their long-term survival. It may develop earlier around implants with rough surfaces and it may represent a true infection. Microbiological sampling methods should be improved and uniformed so as to fully unveil the microbiological profile of the disease. © 2011 John Wiley & Sons A/S.

  13. MIRU-VNTR Genotyping of Mycobacterium tuberculosis Strains Using QIAxcel Technology: A Multicentre Evaluation Study.

    Science.gov (United States)

    Nikolayevskyy, Vladyslav; Trovato, Alberto; Broda, Agnieszka; Borroni, Emanuele; Cirillo, Daniela; Drobniewski, Francis

    2016-01-01

    Molecular genotyping of M.tuberculosis is an important laboratory tool in the context of emerging drug resistant TB. The standard 24-loci MIRU-VNTR typing includes PCR amplification followed by the detection and sizing of PCR fragments using capillary electrophoresis on automated sequencers or using agarose gels. The QIAxcel Advanced system might offer a cost-effective medium-throughput alternative. Performance characteristics of the QIAxcel Advanced platform for the standard 24 VNTR loci panel was evaluated at two centres on a total of 140 DNA specimens using automated capillary electrophoresis as a reference method. Additionally 4 hypervariable MIRU-VNTR loci were evaluated on 53 crude DNA extracts. The sizing accuracy, interlaboratory reproducibility and overall instrument's performance were assessed during the study. An overall concordance with the reference method was high reaching 98.5% and 97.6% for diluted genomic and crude DNA extracts respectively. 91.4% of all discrepancies were observed in fragments longer than 700bp. The concordance for hypervariable loci was lower except for locus 4120 (96.2%). The interlaboratory reproducibility agreement rates were 98.9% and 91.3% for standard and hypervariable loci, respectively. Overall performance of the QIAxcel platform for M.tuberculosis genotyping using a panel of standard loci is comparable to that of established methods for PCR fragments up to 700bp. Inaccuracies in sizing of longer fragments could be resolved through using in-house size markers or introduction of offset values. To conclude, the QiaXcel system could be considered an effective alternative to existing methods in smaller reference and regional laboratories offering good performance and shorter turnaround times.

  14. MIRU-VNTR Genotyping of Mycobacterium tuberculosis Strains Using QIAxcel Technology: A Multicentre Evaluation Study.

    Directory of Open Access Journals (Sweden)

    Vladyslav Nikolayevskyy

    Full Text Available Molecular genotyping of M.tuberculosis is an important laboratory tool in the context of emerging drug resistant TB. The standard 24-loci MIRU-VNTR typing includes PCR amplification followed by the detection and sizing of PCR fragments using capillary electrophoresis on automated sequencers or using agarose gels. The QIAxcel Advanced system might offer a cost-effective medium-throughput alternative.Performance characteristics of the QIAxcel Advanced platform for the standard 24 VNTR loci panel was evaluated at two centres on a total of 140 DNA specimens using automated capillary electrophoresis as a reference method. Additionally 4 hypervariable MIRU-VNTR loci were evaluated on 53 crude DNA extracts. The sizing accuracy, interlaboratory reproducibility and overall instrument's performance were assessed during the study.An overall concordance with the reference method was high reaching 98.5% and 97.6% for diluted genomic and crude DNA extracts respectively. 91.4% of all discrepancies were observed in fragments longer than 700bp. The concordance for hypervariable loci was lower except for locus 4120 (96.2%. The interlaboratory reproducibility agreement rates were 98.9% and 91.3% for standard and hypervariable loci, respectively. Overall performance of the QIAxcel platform for M.tuberculosis genotyping using a panel of standard loci is comparable to that of established methods for PCR fragments up to 700bp. Inaccuracies in sizing of longer fragments could be resolved through using in-house size markers or introduction of offset values. To conclude, the QiaXcel system could be considered an effective alternative to existing methods in smaller reference and regional laboratories offering good performance and shorter turnaround times.

  15. Cause-specific colostomy rates after radiotherapy for anal cancer: a Danish multicentre cohort study.

    Science.gov (United States)

    Sunesen, Kåre G; Nørgaard, Mette; Lundby, Lilli; Havsteen, Hanne; Buntzen, Steen; Thorlacius-Ussing, Ole; Laurberg, Søren

    2011-09-10

    In anal cancer, colostomy-free survival is a measure of anal sphincter preservation after treatment with radiotherapy or chemoradiotherapy. Failure to control anal cancer and complications of treatment are alternative indications for colostomy. However, no data exist on cause-specific colostomy rates. We examined this in a cohort study. Through national registries and review of medical records, we identified patients with anal cancer diagnosed from 1995 to 2003 who had curative-intent radiotherapy or chemoradiotherapy in four Danish centers. We computed cumulative incidence of tumor-related colostomy and therapy-related colostomy, treating colostomy and death as competing events. Follow-up started at completion of radiotherapy and continued throughout 2008. We used competing risk regression to compute hazard ratios (HRs) to compare the cumulative incidence of cause-specific colostomies between age, sex, tumor size, chemotherapy, and local excision before radiotherapy. We included 235 patients with anal cancer. The 5-year cumulative incidences of tumor-related and therapy-related colostomy were 26% (95% CI, 21% to 32%) and 8% (95% CI, 5% to 12%), respectively. Tumor size greater than 6 cm versus less than 4 cm was a risk factor for tumor-related colostomy (adjusted HR, 3.8; 95% CI, 1.7 to 8.1), and local excision before radiotherapy was a risk factor for therapy-related colostomy (adjusted HR, 4.5; 95% CI, 1.5 to 13.5). After curative-intent radiotherapy or chemoradiotherapy, one third of patients had a colostomy, of which one third were related to therapy. Large tumor size was associated with a higher risk of tumor-related colostomy, whereas history of prior excision was associated with an increased incidence of therapy-related colostomy.

  16. Effect of healthy and unhealthy habits on obesity: a multicentric study.

    Science.gov (United States)

    Crovetto, Mirta; Valladares, Macarena; Espinoza, Valentina; Mena, Francisco; Oñate, Gloria; Fernandez, Macarena; Durán-Agüero, Samuel

    2018-02-19

    Our aim was to characterize and compare eating patterns of university students in Chile, by sex and body weight, body mass index, and nutritional status. This was a cross-sectional study. University students (n = 1454) of Chile were evaluated. A self-assessment survey was used to evaluate healthy eating habits using a questionnaire with values between 1 (do not consume) and 5 (consume) for a total of 9 to 45 points (higher values represent better eating habits). Unhealthy habits were assessed with six questions, including consumption of sugary soft drinks, alcohol, fried foods, fast food, and snacks and adding salt to foods without tasting first. Obese students had a lower consumption of healthy foods (P <0.05) compared with normal weight participants. Underweight male participants had higher unhealthy food consumption (P <0.05) and obese women had the lowest score (P <0.05). Protective factors for being overweight/obese were included (odds ratio [OR]  = 0.5; 95% confidence interval [CI] 0.3-0.8), consumption of ≥2 servings of vegetables (OR = 0.5; 95% CI 0.4-0.7). Risk factors included consumption (more than 1 cup a day) of sugary soft drinks (OR = 1.5; 95% CI 1.0-2.1) and male sex (OR = 1.8; 95% CI 1.3-2.4). The consumption of vegetables and belonging to an undergraduate program in health sciences at a university contributed to protection against for obesity. On the other hand, male sex and consumption of sugary drinks were found to be risk factors for obesity. Copyright © 2018 Elsevier Inc. All rights reserved.

  17. RECIST response and variation of circulating tumour cells in phase 1 trials: A prospective multicentric study.

    Science.gov (United States)

    Massard, Christophe; Borget, Isabelle; Farace, Françoise; Aspeslagh, Sandrine; Le Deley, Marie-Cécile; Le Tourneau, Christophe; Bidard, François-Clement; Pierga, Jean-Yves; Dieras, Veronique; Hofman, Paul; Spano, Jean-Philippe; Ferte, Charles; Lacroix, Ludovic; Soria, Jean-Charles

    2017-09-01

    Circulating tumour cell (CTC) counting could be a new biomarker for better evaluation of tumour response to molecules tested in phase I trials. Consenting patients with advanced metastatic cancer referred to various phase I units were enrolled prospectively in this study. CTCs from 7.5 ml of whole blood drawn at baseline and after starting experimental therapy were counted using the CellSearch system, and tumour response was assessed using RECIST 1.1 criteria at baseline and 2 months after treatment initiation. Between March 2010 and May 2013, a total of 326 patients were enrolled, among whom 214 were evaluable (49% male, median age = 56; main cancer types: lung [28], colon [53], ovarian [18], breast [28]). At baseline, we detected ≥1 CTC/7.5 ml in 113/214 patients (53%), and at day 30, we observed ≥1 CTC/7.5 ml in 103/214 patients (48%). Two months after treatment initiation, 11 (5%) of the 214 patients were classified as having a partial response, with no CTCs in 9 of them or a decrease in the CTC count after therapy. In contrast, among the 104 patients (49%) classified as having progressive disease, 38 patients had a higher CTC count. The remaining 99 patients (49%), 33 of whom (33%) had a lower CTC count, were classified as having stable disease. The sensitivity and specificity of CTC variation for predicting progressive disease were 41% (32-51%) and 80% (73-88%) respectively. An early CTC change following therapy does not correlate with RECIST response in patients with advanced cancer enrolled in phase I trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. Multi-Centre Study on Cardiovascular Risk Management on Patients Undergoing AAA Surveillance.

    Science.gov (United States)

    Saratzis, A; Dattani, N; Brown, A; Shalhoub, J; Bosanquet, D; Sidloff, D; Stather, P

    2017-07-01

    The risk of cardiovascular events and death in patients with abdominal aortic aneurysms (AAA) is high. Screening has been introduced to reduce AAA related mortality; however, after AAA diagnosis, cardiovascular modification may be as important to patient outcomes as surveillance. The aim of this study was to assess cardiovascular risk reduction in patients with small AAA. Institutional approval was granted for The Vascular and Endovascular Research Network (VERN) to retrospectively collect data pertaining to cardiovascular risk reduction from four tertiary vascular units in England. Patients with small AAA (January 2013-December 2015) were included. Demographic details, postcode, current medications, and smoking status were recorded using a bespoke electronic database and analysed. In a secondary analysis VERN contacted all AAA screening units in England and Wales to assess their current protocols relating to CV protection. In total, 1053 patients were included (mean age 74 ± 9 years, all men). Of these, 745 patients (70.8%) had been prescribed an antiplatelet agent and 787 (74.7%) a statin. Overall, only 666 patients (63.2%) were prescribed both a statin and antiplatelet. Two hundred and sixty eight patients (32.1%) were current smokers and the proportion of patients who continued to smoke decreased with age. Overall, only 401 patients (48.1%) were prescribed a statin, antiplatelet, and had stopped smoking. In the secondary analysis 38 AAA screening units (84% national coverage) replied. Thirty-one units (82%) suggest changes to the patient's prescription; however, none monitor compliance with these recommendations or assess whether the general practitioner has been made aware of the AAA diagnosis or prescription advice. Many patients with small AAA are not prescribed an antiplatelet/statin, and still smoke cigarettes, and therefore remain at high risk of cardiovascular morbidity and mortality. National guidance to ensure this high risk group of patients is

  19. Treatment, outcome and quality of life after Fournier's gangrene: a multicentre study.

    Science.gov (United States)

    Czymek, R; Kujath, P; Bruch, H-P; Pfeiffer, D; Nebrig, M; Seehofer, D; Guckelberger, O

    2013-12-01

    The object of this study was to describe the course of Fournier's gangrene and assess quality of life in a group of affected patients. We evaluated patients who received inpatient treatment for Fournier's gangrene at five hospitals in northern Germany from 1995 to 2010. Surviving patients were asked to take part in a clinical follow-up and complete the Short-Form 36 (SF-36) quality-of-life questionnaire and a disease-specific questionnaire including a physical examination. Of the 86 patients, 72 (83.7%) were men. The mean age of the patients was 57.9 ± 13.9 (25-89) years. The mean length of hospital stay was 52.0 ± 54.0 (1-329) days. Fourteen (16.3%) patients (eight men) died primarily from Fournier's gangrene. The most common aetiological event was anogenital abscess formation (n = 24; 27.9%). Seventy-one (82.5%) patients had a mixed polymicrobial infection. SF-36 physical role functioning (P = 0.010), physical functioning (P = 0.008), general health (P = 0.010) and physical health summary (P = 0.006) scores were significantly lower than those of the normal population. Deterioration in sexual function was reported by 65% of the patients. Patients with Fournier's gangrene experience persistent physical and mental health problems for a long period of time following their primary hospital stay and must receive long-term care from a variety of specialists, otherwise the disease leads to an increase in the duration of morbidity and a decrease in quality of life. Colorectal Disease © 2013 The Association of Coloproctology of Great Britain and Ireland.

  20. Prolonged suppressive antibiotic therapy for prosthetic joint infection in the elderly: a national multicentre cohort study.

    Science.gov (United States)

    Prendki, V; Ferry, T; Sergent, P; Oziol, E; Forestier, E; Fraisse, T; Tounes, S; Ansart, S; Gaillat, J; Bayle, S; Ruyer, O; Borlot, F; Le Falher, G; Simorre, B; Dauchy, F-A; Greffe, S; Bauer, T; Bell, E N; Martha, B; Martinot, M; Froidure, M; Buisson, M; Waldner, A; Lemaire, X; Bosseray, A; Maillet, M; Charvet, V; Barrelet, A; Wyplosz, B; Noaillon, M; Denes, E; Beretti, E; Berlioz-Thibal, M; Meyssonnier, V; Fourniols, E; Tliba, L; Eden, A; Jean, M; Arvieux, C; Guignery-Kadri, K; Ronde-Oustau, C; Hansmann, Y; Belkacem, A; Bouchand, F; Gavazzi, G; Herrmann, F; Stirnemann, J; Dinh, A

    2017-09-01

    During prosthetic joint infection (PJI), optimal surgical management with exchange of the device is sometimes impossible, especially in the elderly population. Thus, prolonged suppressive antibiotic therapy (PSAT) is the only option to prevent acute sepsis, but little is known about this strategy. We aimed to describe the characteristics, outcome and tolerance of PSAT in elderly patients with PJI. We performed a national cross-sectional cohort study of patients >75 years old and treated with PSAT for PJI. We evaluated the occurrence of events, which were defined as: (i) local or systemic progression of the infection (failure), (ii) death and (iii) discontinuation or switch of PSAT. A total of 136 patients were included, with a median age of 83 years [interquartile range (IQR) 81-88]. The predominant pathogen involved was Staphylococcus (62.1%) (Staphylococcus aureus in 41.7%). A single antimicrobial drug was prescribed in 96 cases (70.6%). There were 46 (33.8%) patients with an event: 25 (18%) with an adverse drug reaction leading to definitive discontinuation or switch of PSAT, 8 (5.9%) with progression of sepsis and 13 died (9.6%). Among patients under follow-up, the survival rate without an event at 2 years was 61% [95% confidence interval (CI): 51;74]. In the multivariate Cox analysis, patients with higher World Health Organization (WHO) score had an increased risk of an event [hazard ratio (HR) = 1.5, p = 0.014], whereas patients treated with beta-lactams are associated with less risk of events occurring (HR = 0.5, p = 0.048). In our cohort, PSAT could be an effective and safe option for PJI in the elderly.

  1. Concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: Treatment outcomes of a prospective, multicentric clinical study

    International Nuclear Information System (INIS)

    Wu, Fang; Wang, Rensheng; Lu, Heming; Wei, Bo; Feng, Guosheng; Li, Guisheng; Liu, Meilian; Yan, Haolin; Zhu, Jinxian; Zhang, Yong; Hu, Kai

    2014-01-01

    Background and purpose: To evaluate long-term outcome in locoregionally advanced nasopharyngeal carcinoma (NPC) treated with intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. Material and methods: Between January 2006 and August 2008, 249 patients with stage III–IVb NPC were treated by IMRT plus concurrent chemotherapy in this multicenter prospective study. Results: With a mean follow-up of 54.1 months, the 5-year actuarial rates of overall survival (OS), local recurrence-free survival (LRFS), regional recurrence-free survival (RRFS), and distant metastasis-free survival (DMFS) were 78.4%, 86.8%, 88.4%, 78.0%, respectively. There were 29 local recurrences, 25 regional recurrences and 52 distant metastases, respectively. Distant metastasis is the main cause of treatment failure. N-stage was an independent prognostic factor for LRFS, RRFS, DMFS and OS. Acute toxicity ⩾grade III mainly consisted of mucositis (34.9%), neutropenia (11.2%), xerostomia (5.6%), and dermatitis (5.2%). The main documented late toxicity was xerostomia, and the severity of xerostomia decreased over time. At 24 months after treatment, 13.2% of patients had grade 2 xerostomia, and none had grade 3 or 4 xerostomia. Conclusions: IMRT with concurrent cisplatin chemotherapy resulted in encouraging rates of local and distant control and overall survival with acceptable rates of acute and limited rates of late toxicity in patients with locoregionally advanced NPC. Distant metastasis remained the main cause of failure. More effective systemic therapy should be explored for patients with advanced N-stage

  2. Actual performance of mechanical ventilators in ICU: a multicentric quality control study.

    Science.gov (United States)

    Govoni, Leonardo; Dellaca', Raffaele L; Peñuelas, Oscar; Bellani, Giacomo; Artigas, Antonio; Ferrer, Miquel; Navajas, Daniel; Pedotti, Antonio; Farré, Ramon

    2012-01-01

    Even if the performance of a given ventilator has been evaluated in the laboratory under very well controlled conditions, inappropriate maintenance and lack of long-term stability and accuracy of the ventilator sensors may lead to ventilation errors in actual clinical practice. The aim of this study was to evaluate the actual performances of ventilators during clinical routines. A resistance (7.69 cmH(2)O/L/s) - elastance (100 mL/cmH(2)O) test lung equipped with pressure, flow, and oxygen concentration sensors was connected to the Y-piece of all the mechanical ventilators available for patients in four intensive care units (ICUs; n = 66). Ventilators were set to volume-controlled ventilation with tidal volume = 600 mL, respiratory rate = 20 breaths/minute, positive end-expiratory pressure (PEEP) = 8 cmH(2)O, and oxygen fraction = 0.5. The signals from the sensors were recorded to compute the ventilation parameters. The average ± standard deviation and range (min-max) of the ventilatory parameters were the following: inspired tidal volume = 607 ± 36 (530-723) mL, expired tidal volume = 608 ± 36 (530-728) mL, peak pressure = 20.8 ± 2.3 (17.2-25.9) cmH(2)O, respiratory rate = 20.09 ± 0.35 (19.5-21.6) breaths/minute, PEEP = 8.43 ± 0.57 (7.26-10.8) cmH(2)O, oxygen fraction = 0.49 ± 0.014 (0.41-0.53). The more error-prone parameters were the ones related to the measure of flow. In several cases, the actual delivered mechanical ventilation was considerably different from the set one, suggesting the need for improving quality control procedures for these machines.

  3. 'You're judged all the time!' Students' views on professionalism: a multicentre study.

    Science.gov (United States)

    Finn, Gabrielle; Garner, Jayne; Sawdon, Marina

    2010-08-01

    This study describes how medical students perceive professionalism and the context in which it is relevant to them. An understanding of how Phase 1 students perceive professionalism will help us to teach this subject more effectively. Phase 1 medical students are those in the first 2 years of a 5-year medical degree. Seventy-two undergraduate students from two UK medical schools participated in 13 semi-structured focus groups. Focus groups, carried out until thematic saturation occurred, were recorded and transcribed verbatim. Data were analysed and coded using NVivo 8, using a grounded theory approach with constant comparison. From the analysis, seven themes regarding professionalism emerged: the context of professionalism; role-modelling; scrutiny of behaviour; professional identity; 'switching on' professionalism; leniency (for students with regard to professional standards), and sacrifice (of freedom as an individual). Students regarded professionalism as being relevant in three contexts: the clinical, the university and the virtual. Students called for leniency during their undergraduate course, opposing the guidance from Good Medical Practice. Unique findings were the impact of clothing and the online social networking site Facebook on professional behaviour and identity. Changing clothing was described as a mechanism by which students 'switch on' their professional identity. Students perceived society to be struggling with the distinction between doctors as individuals and professionals. This extended to the students' online identities on Facebook. Institutions' expectations of high standards of professionalism were associated with a feeling of sacrifice by students caused by the perception of constantly 'being watched'; this perception was coupled with resentment of this intrusion. Students described the significant impact that role-modelling had on their professional attitudes. This research offers valuable insight into how Phase 1 medical students

  4. Quality of life among healthcare workers: a multicentre cross-sectional study in Italy.

    Science.gov (United States)

    Kheiraoui, F; Gualano, M R; Mannocci, A; Boccia, A; La Torre, G

    2012-07-01

    To evaluate the quality of life among doctors, nurses, and occupational safety and health technologists (OSHT). Cross-sectional study was undertaken in a population of healthcare workers in 10 Italian regions. The Italian version of short form-36 (SF-36) was anonymously and voluntarily self-administered by participants to assess the perceived health-related quality of life (HRQOL). The HRQOL scores for the sample and the Italian population were compared. A multiple linear regression was performed to assess the influence of age, gender, role, socializing time, working time, years spent in healthcare and years spent in the specific department on the SF-36 score. The sample included 324 healthcare workers [57.1% women, mean age 39.0 (standard deviation 10.2) years]: 52.6% were medical doctors, 36.8% were nurses and 10.5% were OSHTs. Workers with a career of >15 years achieved a general health score lower than that of workers with a shorter career, while those who spent more time in socializing activities achieved a higher mental health score. The multivariate analysis showed that increasing age is positively related to role emotional levels (β = 0.243; P = 0.002), while it appears to be inversely related to general health (β = -0.218; P = 0.007) and physical function (β = -0.246; P = 0.001). Nurses had lower scores for bodily pain (β = -0.214; P social function (β = -0.242; P = 0.001) and role emotional (β = -0.211; P = 0.006) compared with doctors. Compared with the general Italian population, healthcare workers had higher scores for general health, physical function, role physical, bodily pain and mental health, and lower scores for vitality, social function and role emotional. Healthcare workers have different levels of HRQOL related to their professional role. In particular, nurses have lower quality of life. These results may help to identify the main roles and attitudes that could cause frustration, dissatisfaction and emotional stress in healthcare

  5. Erythropoietin in amyotrophic lateral sclerosis: a multicentre, randomised, double blind, placebo controlled, phase III study.

    Science.gov (United States)

    Lauria, Giuseppe; Dalla Bella, Eleonora; Antonini, Giovanni; Borghero, Giuseppe; Capasso, Margherita; Caponnetto, Claudia; Chiò, Adriano; Corbo, Massimo; Eleopra, Roberto; Fazio, Raffaella; Filosto, Massimiliano; Giannini, Fabio; Granieri, Enrico; La Bella, Vincenzo; Logroscino, Giancarlo; Mandrioli, Jessica; Mazzini, Letizia; Monsurrò, Maria Rosaria; Mora, Gabriele; Pietrini, Vladimiro; Quatrale, Rocco; Rizzi, Romana; Salvi, Fabrizio; Siciliano, Gabriele; Sorarù, Gianni; Volanti, Paolo; Tramacere, Irene; Filippini, Graziella

    2015-08-01

    To assess the efficacy of recombinant human erythropoietin (rhEPO) in amyotrophic lateral sclerosis (ALS). Patients with probable laboratory-supported, probable or definite ALS were enrolled by 25 Italian centres and randomly assigned (1:1) to receive intravenous rhEPO 40,000 IU or placebo fortnightly as add-on treatment to riluzole 100 mg daily for 12 months. The primary composite outcome was survival, tracheotomy or >23 h non-invasive ventilation (NIV). Secondary outcomes were ALSFRS-R, slow vital capacity (sVC) and quality of life (ALSAQ-40) decline. Tolerability was evaluated analysing adverse events (AEs) causing withdrawal. The randomisation sequence was computer-generated by blocks, stratified by centre, disease severity (ALSFRS-R cut-off score of 33) and onset (spinal or bulbar). The main outcome analysis was performed in all randomised patients and by intention-to-treat for the entire population and patients stratified by severity and onset. The study is registered, EudraCT 2009-016066-91. We randomly assigned 208 patients, of whom 5 (1 rhEPO and 4 placebo) withdrew consent and 3 (placebo) became ineligible (retinal thrombosis, respiratory insufficiency, SOD1 mutation) before receiving treatment; 103 receiving rhEPO and 97 placebo were eligible for analysis. At 12 months, the annualised rate of death (rhEPO 0.11, 95% CI 0.06 to 0.20; placebo: 0.08, CI 0.04 to 0.17), tracheotomy or >23 h NIV (rhEPO 0.16, CI 0.10 to 0.27; placebo 0.18, CI 0.11 to 0.30) did not differ between groups, also after stratification by onset and ALSFRS-R at baseline. Withdrawal due to AE was 16.5% in rhEPO and 8.3% in placebo. No differences were found for secondary outcomes. RhEPO 40,000 IU fortnightly did not change the course of ALS. 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. Cost of elective percutaneous coronary intervention in Malaysia: a multicentre cross-sectional costing study.

    Science.gov (United States)

    Lee, Kun Yun; Ong, Tiong Kiam; Low, Ee Vien; Liow, Siow Yen; Anchah, Lawrence; Hamzah, Syuhada; Liew, Houng Bang; Ali, Rosli Mohd; Ismail, Omar; Ahmad, Wan Azman Wan; Said, Mas Ayu; Dahlui, Maznah

    2017-05-28

    Limitations in the quality and access of cost data from low-income and middle-income countries constrain the implementation of economic evaluations. With the increasing prevalence of coronary artery disease in Malaysia, cost information is vital for cardiac service expansion. We aim to calculate the hospitalisation cost of percutaneous coronary intervention (PCI), using a data collection method customised to local setting of limited data availability. This is a cross-sectional costing study from the perspective of healthcare providers, using top-down approach, from January to June 2014. Cost items under each unit of analysis involved in the provision of PCI service were identified, valuated and calculated to produce unit cost estimates. Five public cardiac centres participated. All the centres provide full-fledged cardiology services. They are also the tertiary referral centres of their respective regions. The cost was calculated for elective PCI procedure in each centre. PCI conducted for urgent/emergent indication or for patients with shock and haemodynamic instability were excluded. The outcome measures of interest were the unit costs at the two units of analysis, namely cardiac ward admission and cardiac catheterisation utilisation, which made up the total hospitalisation cost. The average hospitalisation cost ranged between RM11 471 (US$3186) and RM14 465 (US$4018). PCI consumables were the dominant cost item at all centres. The centre with daycare establishment recorded the lowest admission cost and total hospitalisation cost. Comprehensive results from all centres enable comparison at the levels of cost items, unit of analysis and total costs. This generates important information on cost variations between centres, thus providing valuable guidance for service planning. Alternative procurement practices for PCI consumables may deliver cost reduction. For countries with limited data availability, costing method tailored based on country setting can be used for

  7. Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study.

    Science.gov (United States)

    Jun, Min; Lix, Lisa M; Durand, Madeleine; Dahl, Matt; Paterson, J Michael; Dormuth, Colin R; Ernst, Pierre; Yao, Shenzhen; Renoux, Christel; Tamim, Hala; Wu, Cynthia; Mahmud, Salaheddin M; Hemmelgarn, Brenda R

    2017-10-17

    Objective  To determine the safety of direct oral anticoagulant (DOAC) use compared with warfarin use for the treatment of venous thromboembolism. Design  Retrospective matched cohort study conducted between 1 January 2009 and 31 March 2016. Setting  Community based, using healthcare data from six jurisdictions in Canada and the United States. Participants  59 525 adults (12 489 DOAC users; 47 036 warfarin users) with a new diagnosis of venous thromboembolism and a prescription for a DOAC or warfarin within 30 days of diagnosis. Main outcome measures  Outcomes included hospital admission or emergency department visit for major bleeding and all cause mortality within 90 days after starting treatment. Propensity score matching and shared frailty models were used to estimate adjusted hazard ratios of the outcomes comparing DOACs with warfarin. Analyses were conducted independently at each site, with meta-analytical methods used to estimate pooled hazard ratios across sites. Results  Of the 59 525 participants, 1967 (3.3%) had a major bleed and 1029 (1.7%) died over a mean follow-up of 85.2 days. The risk of major bleeding was similar for DOAC compared with warfarin use (pooled hazard ratio 0.92, 95% confidence interval 0.82 to 1.03), with the overall direction of the association favouring DOAC use. No difference was found in the risk of death (pooled hazard ratio 0.99, 0.84 to 1.16) for DOACs compared with warfarin use. There was no evidence of heterogeneity across centres, between patients with and without chronic kidney disease, across age groups, or between male and female patients. Conclusions  In this analysis of adults with incident venous thromboembolism, treatment with DOACs, compared with warfarin, was not associated with an increased risk of major bleeding or all cause mortality in the first 90 days of treatment. Trial registration  Clinical trials NCT02833987. Published by the BMJ Publishing Group Limited. For permission to use (where not

  8. Actual performance of mechanical ventilators in ICU: a multicentric quality control study

    Directory of Open Access Journals (Sweden)

    Govoni L

    2012-12-01

    Full Text Available Leonardo Govoni,1 Raffaele L Dellaca,1 Oscar Peñuelas,2,3 Giacomo Bellani,4,5 Antonio Artigas,3,6 Miquel Ferrer,3,7 Daniel Navajas,3,8,9 Antonio Pedotti,1 Ramon Farré3,81TBM-Lab, Dipartimento di Bioingegneria, Politecnico di Milano University, Milano, Italy; 2Hospital Universitario de Getafe – CIBERES, Madrid, Spain; 3CIBER de Enfermedades Respiratorias, Bunyola, Spain; 4Department of Experimental Medicine, University of Milan, Bicocca, Italy; 5Department of Perioperative Medicine and Intensive Care, San Gerardo Hospital, Monza (MI, Italy; 6Critical Care Center, Sabadell Hospital, Corporació Sanitaria Universitaria Parc Tauli, Universitat Autonoma de Barcelona, CIBERES, Spain; 7Department of Pneumology, Hospital Clinic, IDIBAPS, Barcelona, Spain; 8Unitat de Biofísica i Bioenginyeria, Facultat de Medicina, Universidad de Barcelona-IDIBAPS, Barcelona, Spain; 9Institut de Bioenginyeria de Catalunya, Barcelona, SpainAbstract: Even if the performance of a given ventilator has been evaluated in the laboratory under very well controlled conditions, inappropriate maintenance and lack of long-term stability and accuracy of the ventilator sensors may lead to ventilation errors in actual clinical practice. The aim of this study was to evaluate the actual performances of ventilators during clinical routines. A resistance (7.69 cmH2O/L/s – elastance (100 mL/cmH2O test lung equipped with pressure, flow, and oxygen concentration sensors was connected to the Y-piece of all the mechanical ventilators available for patients in four intensive care units (ICUs; n = 66. Ventilators were set to volume-controlled ventilation with tidal volume = 600 mL, respiratory rate = 20 breaths/minute, positive end-expiratory pressure (PEEP = 8 cmH2O, and oxygen fraction = 0.5. The signals from the sensors were recorded to compute the ventilation parameters. The average ± standard deviation and range (min–max of the ventilatory parameters were the following: inspired

  9. 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).

  10. Detection of residual disease after neoadjuvant chemoradiotherapy for oesophageal cancer (preSANO): a prospective multicentre, diagnostic cohort study.

    Science.gov (United States)

    Noordman, Bo Jan; Spaander, Manon C W; Valkema, Roelf; Wijnhoven, Bas P L; van Berge Henegouwen, Mark I; Shapiro, Joël; Biermann, Katharina; van der Gaast, Ate; van Hillegersberg, Richard; Hulshof, Maarten C C M; Krishnadath, Kausilia K; Lagarde, Sjoerd M; Nieuwenhuijzen, Grard A P; Oostenbrug, Liekele E; Siersema, Peter D; Schoon, Erik J; Sosef, Meindert N; Steyerberg, Ewout W; van Lanschot, J Jan B

    2018-05-31

    After neoadjuvant chemoradiotherapy for oesophageal cancer, roughly half of the patients with squamous cell carcinoma and a quarter of those with adenocarcinoma have a pathological complete response of the primary tumour before surgery. Thus, the necessity of standard oesophagectomy after neoadjuvant chemoradiotherapy should be reconsidered for patients who respond sufficiently to neoadjuvant treatment. In this study, we aimed to establish the accuracy of detection of residual disease after neoadjuvant chemoradiotherapy with different diagnostic approaches, and the optimal combination of diagnostic techniques for clinical response evaluations. The preSANO trial was a prospective, multicentre, diagnostic cohort study at six centres in the Netherlands. Eligible patients were aged 18 years or older, had histologically proven, resectable, squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophagogastric junction, and were eligible for potential curative therapy with neoadjuvant chemoradiotherapy (five weekly cycles of carboplatin [area under the curve 2 mg/mL per min] plus paclitaxel [50 mg/m 2 of body-surface area] combined with 41·4 Gy radiotherapy in 23 fractions) followed by oesophagectomy. 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients had oesophagogastroduodenoscopy with biopsies and endoscopic ultrasonography with measurement of maximum tumour thickness. Patients with histologically proven locoregional residual disease or no-pass during endoscopy and without distant metastases underwent immediate surgical resection. In the remaining patients a second clinical response evaluation was done (PET-CT, oesophagogastroduodenoscopy with biopsies, endoscopic ultrasonography with measurement of maximum tumour thickness, and fine-needle aspiration of suspicious lymph nodes), followed by surgery 12-14 weeks after completion of neoadjuvant chemoradiotherapy. The primary endpoint was the correlation between clinical response during

  11. International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study.

    Science.gov (United States)

    Crawford, Mike J; Gold, Christian; Odell-Miller, Helen; Thana, Lavanya; Faber, Sarah; Assmus, Jörg; Bieleninik, Łucja; Geretsegger, Monika; Grant, Claire; Maratos, Anna; Sandford, Stephan; Claringbold, Amy; McConachie, Helen; Maskey, Morag; Mössler, Karin Antonia; Ramchandani, Paul; Hassiotis, Angela

    2017-10-01

    Preliminary studies have indicated that music therapy may benefit children with autism spectrum disorders (ASD). To examine the effects of improvisational music therapy (IMT) on social affect and responsiveness of children with ASD. International, multicentre, three-arm, single-masked randomised controlled trial, including a National Institute for Health Research (NIHR)-funded centre that recruited in London and the east of England. Randomisation was via a remote service using permuted blocks, stratified by study site. Schools and private, voluntary and state-funded health-care services. Children aged between 4 and 7 years with a confirmed diagnosis of ASD and a parent or guardian who provided written informed consent. We excluded children with serious sensory disorder and those who had received music therapy within the past 12 months. All parents and children received enhanced standard care (ESC), which involved three 60-minute sessions of advice and support in addition to treatment as usual. In addition, they were randomised to either one (low-frequency) or three (high-frequency) sessions of IMT per week, or to ESC alone, over 5 months in a ratio of 1 : 1 : 2. The primary outcome was measured using the social affect score derived from the Autism Diagnostic Observation Schedule (ADOS) at 5 months: higher scores indicated greater impairment. Secondary outcomes included social affect at 12 months and parent-rated social responsiveness at 5 and 12 months (higher scores indicated greater impairment). A total of 364 participants were randomised between 2011 and 2015. A total of 182 children were allocated to IMT (90 to high-frequency sessions and 92 to low-frequency sessions), and 182 were allocated to ESC alone. A total of 314 (86.3%) of the total sample were followed up at 5 months [165 (90.7%) in the intervention group and 149 (81.9%) in the control group]. Among those randomised to IMT, 171 (94.0%) received it. From baseline to 5 months, mean scores of ADOS

  12. 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

  13. 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

  14. 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

  15. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study.

    Science.gov (United States)

    Dorman, Susan E; Schumacher, Samuel G; Alland, David; Nabeta, Pamela; Armstrong, Derek T; King, Bonnie; Hall, Sandra L; Chakravorty, Soumitesh; Cirillo, Daniela M; Tukvadze, Nestani; Bablishvili, Nino; Stevens, Wendy; Scott, Lesley; Rodrigues, Camilla; Kazi, Mubin I; Joloba, Moses; Nakiyingi, Lydia; Nicol, Mark P; Ghebrekristos, Yonas; Anyango, Irene; Murithi, Wilfred; Dietze, Reynaldo; Lyrio Peres, Renata; Skrahina, Alena; Auchynka, Vera; Chopra, Kamal Kishore; Hanif, Mahmud; Liu, Xin; Yuan, Xing; Boehme, Catharina C; Ellner, Jerrold J; Denkinger, Claudia M

    2018-01-01

    The Xpert MTB/RIF assay is an automated molecular test that has improved the detection of tuberculosis and rifampicin resistance, but its sensitivity is inadequate in patients with paucibacillary disease or HIV. Xpert MTB/RIF Ultra (Xpert Ultra) was developed to overcome this limitation. We compared the diagnostic performance of Xpert Ultra with that of Xpert for detection of tuberculosis and rifampicin resistance. In this prospective, multicentre, diagnostic accuracy study, we recruited adults with pulmonary tuberculosis symptoms presenting at primary health-care centres and hospitals in eight countries (South Africa, Uganda, Kenya, India, China, Georgia, Belarus, and Brazil). Participants were allocated to the case detection group if no drugs had been taken for tuberculosis in the past 6 months or to the multidrug-resistance risk group if drugs for tuberculosis had been taken in the past 6 months, but drug resistance was suspected. Demographic information, medical history, chest imaging results, and HIV test results were recorded at enrolment, and each participant gave at least three sputum specimen on 2 separate days. Xpert and Xpert Ultra diagnostic performance in the same sputum specimen was compared with culture tests and drug susceptibility testing as reference standards. The primary objectives were to estimate and compare the sensitivity of Xpert Ultra test with that of Xpert for detection of smear-negative tuberculosis and rifampicin resistance and to estimate and compare Xpert Ultra and Xpert specificities for detection of rifampicin resistance. Study participants in the case detection group were included in all analyses, whereas participants in the multidrug-resistance risk group were only included in analyses of rifampicin-resistance detection. Between Feb 18, and Dec 24, 2016, we enrolled 2368 participants for sputum sampling. 248 participants were excluded from the analysis, and 1753 participants were distributed to the case detection group (n=1439

  16. 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.

  17. 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.

  18. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study.

    Science.gov (United States)

    Beigel, John H; Tebas, Pablo; Elie-Turenne, Marie-Carmelle; Bajwa, Ednan; Bell, Todd E; Cairns, Charles B; Shoham, Shmuel; Deville, Jaime G; Feucht, Eric; Feinberg, Judith; Luke, Thomas; Raviprakash, Kanakatte; Danko, Janine; O'Neil, Dorothy; Metcalf, Julia A; King, Karen; Burgess, Timothy H; Aga, Evgenia; Lane, H Clifford; Hughes, Michael D; Davey, Richard T

    2017-06-01

    Influenza causes substantial morbidity and mortality despite available treatments. Anecdotal reports suggest that plasma with high antibody titres to influenza might be of benefit in the treatment of severe influenza. In this randomised, open-label, multicentre, phase 2 trial, 29 academic medical centres in the USA assessed the safety and efficacy of anti-influenza plasma with haemagglutination inhibition antibody titres of 1:80 or more to the infecting strain. Hospitalised children and adults (including pregnant women) with severe influenza A or B (defined as the presence of hypoxia or tachypnoea) were randomly assigned to receive either two units (or paediatric equivalent) of anti-influenza plasma plus standard care, versus standard care alone, and were followed up for 28 days. The primary endpoint was time to normalisation of patients' respiratory status (respiratory rate of ≤20 breaths per min for adults or age-defined thresholds of 20-38 breaths per min for children) and a room air oxygen saturation of 93% or more. This study is registered with ClinicalTrials.gov, number NCT01052480. Between Jan 13, 2011, and March 2, 2015, 113 participants were screened for eligibility and 98 were randomly assigned from 20 out of 29 participating sites. Of the participants with confirmed influenza (by PCR), 28 (67%) of 42 in the plasma plus standard care group normalised their respiratory status by day 28 compared with 24 (53%) of 45 participants on standard care alone (p=0·069). The hazard ratio (HR) comparing plasma plus standard care with standard care alone was 1·71 (95% CI 0·96-3·06). Six participants died, one (2%) from the plasma plus standard care group and five (10%) from the standard care group (HR 0·19 [95% CI 0·02-1·65], p=0·093). Participants in the plasma plus standard care group had non-significant reductions in days in hospital (median 6 days [IQR 4-16] vs 11 days [5-25], p=0·13) and days on mechanical ventilation (median 0 days [IQR 0-6] vs 3 days

  19. Los implantes MG-OSSEOUS: Estudio multicéntrico retrospectivo MG-OSSEOUS implants: A multicentric retrospective study

    Directory of Open Access Journals (Sweden)

    E. Serrano Caturla

    2006-12-01

    commercial implants. Material and methodology. This is a retrospective multicentric study coordinated by a company called Scientific Management in O&SS (Barcelona, Spain. 1001 dental implants were placed in 247 patients and 328 prostheses were designed between 2004 and 2005, with a follow-up of two years. All implants were loaded with prostheses. We detail and analyze each implant, according to the diameter, length, position, surgical timing, loadings, design and types of prostheses and complementary surgical procedures, either synchronic or metachronic. Results. After the statistical method was homogenized, we were able to report an overall implant survival rate of 97.8% with monitoring of two years. The failures depending on the peculiarities of each clinical case are provided. No prosthetic failures are reported. Discussion. The criteria and indications applied by the professionals to the MG-OSSEOUS implants are standardized depending on the clinical case. Our results are compared with the international scientific literature, past and present, with these procedures totally agreeing with those found in the history of implantology. Finally, our survey is compared with those published by the Branemark team. Conclusion. The mixture between the quality of the MGOSSEOUS implants and the scientifically supported criteria regarding the implants, reveals an implant failure of 2.2% over two years, with a survival of 100% of both the replaced implants and the loaded prostheses.

  20. 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'

  1. 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.)

  2. 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.)

  3. 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

  4. 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

  5. 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....

  6. 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...

  7. 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...

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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.

  16. 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....

  17. 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.

  18. 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.

  19. The prevalence of lymphogranuloma venereum infection in men who have sex with men: results of a multicentre case finding study

    Science.gov (United States)

    Ward, H; Alexander, S; Carder, C; Dean, G; French, P; Ivens, D; Ling, C; Paul, J; Tong, W; White, J; Ison, C A

    2009-01-01

    Objective: To determine the prevalence of lymphogranuloma venereum (LGV) and non-LGV associated serovars of urethral and rectal Chlamydia trachomatis (CT) infection in men who have sex with men (MSM). Design: Multicentre cross-sectional survey. Setting: Four genitourinary medicine clinics in the United Kingdom from 2006–7. Subjects: 4825 urethral and 6778 rectal samples from consecutive MSM attending for sexual health screening. Methods: Urethral swabs or urine and rectal swabs were tested for CT using standard nucleic acid amplification tests. Chlamydia-positive specimens were sent to the reference laboratory for serovar determination. Main outcome: Positivity for both LGV and non-LGV associated CT serovars; proportion of cases that were symptomatic. Results: The positivity (with 95% confidence intervals) in rectal samples was 6.06% (5.51% to 6.66%) for non-LGV CT and 0.90% (0.69% to 1.16%) for LGV; for urethral samples 3.21% (2.74% to 3.76%) for non-LGV CT and 0.04% (0.01% to 0.16%) for LGV. The majority of LGV was symptomatic (95% of rectal, one of two urethral cases); non-LGV chlamydia was mostly symptomatic in the urethra (68%) but not in the rectum (16%). Conclusions: Chlamydial infections are common in MSM attending for sexual health screening, and the majority are non-LGV associated serovars. We did not identify a large reservoir of asymptomatic LGV in the rectum or urethra. Testing for chlamydia from the rectum and urethra should be included for MSM requesting a sexual health screen, but serovar-typing is not indicated in the absence of symptoms. We have yet to identify the source of most cases of LGV in the UK. PMID:19221105

  20. 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.

  1. Patient-controlled hospital admission for patients with severe mental disorders: study protocol for a nationwide prospective multicentre study.

    Science.gov (United States)

    Thomsen, Christoffer Torgaard; Benros, Michael Eriksen; Hastrup, Lene Halling; Andersen, Per Kragh; Giacco, Domenico; Nordentoft, Merete

    2016-09-28

    Patient-controlled hospital admission for individuals with severe mental disorders is a novel approach in mental healthcare. Patients can admit themselves to a hospital unit for a short stay without being assessed by a psychiatrist or contacting the emergency department. Previous studies assessing the outcomes of patient-controlled hospital admission found trends towards reduction in the use of coercive measures and length of hospital stay; however, these studies have methodological shortcomings and small sample sizes. Larger studies are needed to estimate the effect of patient-controlled hospital admission on the use of coercion and of healthcare services. We aim to recruit at least 315 patients who are offered a contract for patient-controlled hospital admissions in eight different hospitals in Denmark. Patients will be followed-up for at least 1 year to compare the use of coercive measures and of healthcare services, the use of medications and suicidal behaviour. Descriptive statistics will be used to investigate hospitalisations, global assessment of functioning (GAF) and patient satisfaction with treatment. To minimise selection bias, we will match individuals using patient-controlled hospital admission and controls with a 1:5 ratio via a propensity score based on the following factors: sex, age group, primary diagnosis, substance abuse as secondary diagnosis, coercion, number of psychiatric bed days, psychiatric history, urbanity and suicidal behaviour. Additionally, a historical control study will be undertaken in which patients serve as their own control group prior to index date. The study has been approved by The Danish Health and Medicines Authority (j.nr.: 3-3013-934/1/) and by The Danish Data Protection Agency (j.nr.: 2012-58-0004). The study was categorised as a register study by The Danish Health Research Ethics Committee and therefore no further approval was needed (j.nr.: H-2-2014-FSP70). Findings will be disseminated through scientific

  2. Multicentric randomised study of Helicobacter pylori eradication and pepsinogen testing for prevention of gastric cancer mortality: the GISTAR study.

    Science.gov (United States)

    Leja, Marcis; Park, Jin Young; Murillo, Raul; Liepniece-Karele, Inta; Isajevs, Sergejs; Kikuste, Ilze; Rudzite, Dace; Krike, Petra; Parshutin, Sergei; Polaka, Inese; Kirsners, Arnis; Santare, Daiga; Folkmanis, Valdis; Daugule, Ilva; Plummer, Martyn; Herrero, Rolando

    2017-08-11

    Population-based eradication of Helicobacter pylori has been suggested to be cost-effective and is recommended by international guidelines. However, the potential adverse effects of widespread antibiotic use that this would entail have not been sufficiently studied. An alternative way to decrease gastric cancer mortality is by non-invasive search for precancerous lesions, in particular gastric atrophy; pepsinogen tests are the best currently available alternative. The primary objective of GISTAR is to determine whether H pylori eradication combined with pepsinogen testing reduces mortality from gastric cancer among 40-64-year-old individuals. The secondary objectives include evaluation of H pylori eradication effectiveness in gastric cancer prevention in patients with precancerous lesions and evaluation of the potential adverse events, including effects on microbiome. Individuals are recruited from general population (50% men) in areas with high gastric cancer risk in Europe and undergo detailed lifestyle and medical history questionnaire before being randomly allocated to intervention or control groups. The intervention group undergoes H pylori testing and is offered eradication therapy if positive; in addition, pepsinogen levels are detected in plasma and those with decreased levels are referred for upper endoscopy. All participants are offered faecal occult blood testing as an incentive for study participation. Effectiveness of eradication and the spectrum of adverse events are evaluated in study subpopulations. A 35% difference in gastric cancer mortality between the groups is expected to be detectable at 90% power after 15 years if 30 000 individuals are recruited. Biological materials are biobanked for the main and ancillary studies. The study procedure and assumptions will be tested during the pilot phase. The study was approved by the respective ethics committees. An independent Data Safety and Monitoring Board has been established. The findings will be

  3. Surgical outcome in patients taking concomitant or recent intake of oral isotretinoin: A multicentric Study-ISO-AIMS study

    Directory of Open Access Journals (Sweden)

    Omprakash Heggadahalli Mahadevappa

    2016-01-01

    Full Text Available Background: The current standard recommendation is to avoid surgical interventions in patients taking oral isotretinoin. However, this recommendation has been questioned in several recent publications. Aim: To document the safety of cosmetic and surgical interventions, among patients receiving or recently received oral isotretinoin. Materials and Methods: Association of Cutaneous Surgeons, India, in May 2012, initiated this study, at 11 centers in different parts of India. The data of 183 cases were collected monthly, from June 2012 to May 2013. Of these 61 patients had stopped oral isotretinoin before surgery and 122 were concomitantly taking oral isotretinoin during the study period. In these 183 patients, a total of 504 interventions were performed. These included[1] 246 sessions of chemical peels such as glycolic acid, salicylic acid, trichloroacetic acid, and combination peels;[2] 158 sessions of lasers such as ablative fractional laser resurfacing with erbium-doped yttrium aluminum garnet and CO2, conventional full face CO2laser resurfacing, laser-assisted hair reduction with long-pulsed neodymium-doped yttrium aluminum garnet, diode laser, and LASIK surgery;[3] 27 sessions of cold steel surgeries such as microneedling, skin biopsy, subcision, punch elevation of scars, excision of skin lesion, and wisdom tooth extraction;[4] 1 session of electrosurgery. Results: No significant side effects were noted in most patients. 2 cases of keloid were documented which amounted to 0.4% of side effects in 504 interventions, with a significant P value of 0.000. Reversible transient side effects were erythema in 10 interventions and hyperpigmentation in 15. Conclusion: The study showed that performing dermatosurgical and laser procedures in patients receiving or recently received isotretinoin is safe, and the current guidelines of avoiding dermatosurgical and laser interventions in such patients taking isotretinoin need to be revised.

  4. Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

    Energy Technology Data Exchange (ETDEWEB)

    Prince, Martin R. [Weill Cornell Medical College, Department of Radiology, New York, NY (United States); Columbia College of Physicians and Surgeons, Department of Radiology, New York, NY (United States); Lee, Hae Giu [Seoul St. Mary' s Hospital, The Catholic University of Korea, College of Medicine, Department of Radiology, Seoul (Korea, Republic of); Lee, Chang-Hee [Korea University Guro Hospital, Department of Radiology, Seoul (Korea, Republic of); Youn, Sung Won [Catholic University of Daegu Medical Center, Department of Radiology, Daegu (Korea, Republic of); Lee, In Ho [Chungnam National University Hospital, Chungnam National University School of Medicine, Department of Radiology, Daejeon (Korea, Republic of); Yoon, Woong [Chonnam National University Hospital, Department of Radiology, Gwangju (Korea, Republic of); Yang, Benqiang [General Hospital of Shenyang Military Region, Department of Radiology, Shenyang (China); Wang, Haiping [Tangshan Worker' s Hospital, Department of Radiology, Tangshan (China); Wang, Jin [Third Affiliated Hospital of Sun Yat-Sen University, Department of Radiology, Guangzhou (China); Shih, Tiffany Ting-fang [National Taiwan University, Medical College and Hospital, Department of Radiology and Medical Imaging, Taipei (China); Huang, Guo-Shu [National Defense Medical Center, Department of Radiology, Tri-Service General Hospital, Taipei (China); Lirng, Jiing-Feng [Taipei Veterans General Hospital, Department of Radiology, Taipei (China); Palkowitsch, Petra [Medical and Clinical Affairs Radiology, Bayer Pharmaceutical Division, Berlin (Germany); Collaboration: on behalf of the GARDIAN study group

    2017-01-15

    To investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting. GARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events. Median gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications. The GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population. (orig.)

  5. Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

    International Nuclear Information System (INIS)

    Prince, Martin R.; Lee, Hae Giu; Lee, Chang-Hee; Youn, Sung Won; Lee, In Ho; Yoon, Woong; Yang, Benqiang; Wang, Haiping; Wang, Jin; Shih, Tiffany Ting-fang; Huang, Guo-Shu; Lirng, Jiing-Feng; Palkowitsch, Petra

    2017-01-01

    To investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting. GARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events. Median gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications. The GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population. (orig.)

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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

  11. Cohort profile of BIOMArCS: the BIOMarker study to identify the Acute risk of a Coronary Syndrome-a prospective multicentre biomarker study conducted in the Netherlands.

    Science.gov (United States)

    Oemrawsingh, Rohit M; Akkerhuis, K Martijn; Umans, Victor A; Kietselaer, Bas; Schotborgh, Carl; Ronner, Eelko; Lenderink, Timo; Liem, Anho; Haitsma, David; van der Harst, Pim; Asselbergs, Folkert W; Maas, Arthur; Oude Ophuis, Anton J; Ilmer, Ben; Dijkgraaf, Rene; de Winter, Robbert-Jan; The, S Hong Kie; Wardeh, Alexander J; Hermans, Walter; Cramer, Etienne; van Schaik, Ron H; Hoefer, Imo E; Doevendans, Pieter A; Simoons, Maarten L; Boersma, Eric

    2016-12-23

    Progression of stable coronary artery disease (CAD) towards acute coronary syndrome (ACS) is a dynamic and heterogeneous process with many intertwined constituents, in which a plaque destabilising sequence could lead to ACS within short time frames. Current CAD risk assessment models, however, are not designed to identify increased vulnerability for the occurrence of coronary events within a precise, short time frame at the individual patient level. The BIOMarker study to identify the Acute risk of a Coronary Syndrome (BIOMArCS) was designed to evaluate whether repeated measurements of multiple biomarkers can predict such 'vulnerable periods'. BIOMArCS is a multicentre, prospective, observational study of 844 patients presenting with ACS, either with or without ST-elevation and at least one additional cardiovascular risk factor. We hypothesised that patterns of circulating biomarkers that reflect the various pathophysiological components of CAD, such as distorted lipid metabolism, vascular inflammation, endothelial dysfunction, increased thrombogenicity and ischaemia, diverge in the days to weeks before a coronary event. Divergent biomarker patterns, identified by serial biomarker measurements during 1-year follow-up might then indicate 'vulnerable periods' during which patients with CAD are at high short-term risk of developing an ACS. Venepuncture was performed every fortnight during the first half-year and monthly thereafter. As prespecified, patient enrolment was terminated after the primary end point of cardiovascular death or hospital admission for non-fatal ACS had occurred in 50 patients. A case-cohort design will explore differences in temporal patterns of circulating biomarkers prior to the repeat ACS. Follow-up and event adjudication have been completed. Prespecified biomarker analyses are currently being performed and dissemination through peer-reviewed publications and conference presentations is expected from the third quarter of 2016. Should

  12. 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.

  13. 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.

  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. 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

  17. 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.

  18. 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.

  19. 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.)

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. [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.

  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

    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.)

  7. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study

    International Nuclear Information System (INIS)

    Martín-Richard, Marta; Sala, Maria Angeles; Pericay, Carlos; Rivera, Fernando; Sastre, Javier; Segura, Ángel; Quindós, Maria; Maisonobe, Pascal; Massutí, Bartomeu; Pineda, Eva; Alonso, Vicente; Marmol, Maribel; Castellano, Daniel; Fonseca, Emilio; Galán, Antonio; Llanos, Marta

    2013-01-01

    Somatostatin analogues (SSAs) are indicated to relieve carcinoid syndrome but seem to have antiproliferative effects on neuroendocrine tumours (NETs). This is the first prospective study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progressive NETs. This was a multicentre, open-label, phase II trial conducted in 17 Spanish specialist centres. Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, tumour biomarkers, symptom control, quality of life (QoL), and safety. Radiographic imaging was assessed by a blinded central radiologist. Of 30 patients included in the efficacy and safety analyses, 40% had midgut tumours and 27% pancreatic tumours; 63% of tumours were functioning. Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%). No deterioration in QoL was observed. Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe. Lanreotide Autogel provided effective tumour stabilisation and PFS >12 months in patients with progressive NETs ineligible for surgery or chemotherapy, with a safety profile consistent with the pharmacology of the class. ClinicalTrials.gov Identifier http://clinicaltrials.gov/show/NCT00326469; EU Clinical Trial Register EudraCT no 2004-002871-18

  8. 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...

  9. 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.)

  10. 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.

  11. Impact of the recent recession on self-harm: Longitudinal ecological and patient-level investigation from the Multicentre Study of Self-harm in England.

    Science.gov (United States)

    Hawton, Keith; Bergen, Helen; Geulayov, Galit; Waters, Keith; Ness, Jennifer; Cooper, Jayne; Kapur, Navneet

    2016-02-01

    Economic recessions are associated with increases in suicide rates but there is little information for non-fatal self-harm. To investigate the impact of the recent recession on rates of self-harm in England and problems faced by patients who self-harm. Analysis of data from the Multicentre Study of Self-harm in England for 2001-2010 and local employment statistics for Oxford, Manchester and Derby, including interrupted time series analyses to estimate the effect of the recession on rates of self-harm. Rates of self-harm increased in both genders in Derby and in males in Manchester in 2008-2010, but not in either gender in Oxford, results which largely followed changes in general population unemployment. More patients who self-harm were unemployed in 2008-10 compared to before the recession. The proportion in receipt of sickness or disability allowances decreased. More patients of both genders had employment and financial problems in 2008-2010 and more females also had housing problems, changes which were also largely found in employed patients. We have assumed that the recession began in 2008 and information on problems was only available for patients having a psychosocial assessment. Increased rates of self-harm were found in areas where there were greater rises in rates of unemployment. Work, financial and housing problems increased in people who self-harmed. Changes in welfare benefits may have contributed. None. Copyright © 2015 Elsevier B.V. All rights reserved.

  12. 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.)

  13. 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.

  14. 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.

  15. 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.

  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. '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.

  18. 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

  19. 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

  20. 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.

  1. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study.

    Science.gov (United States)

    Timmermann, Lars; Jain, Roshini; Chen, Lilly; Maarouf, Mohamed; Barbe, Michael T; Allert, Niels; Brücke, Thomas; Kaiser, Iris; Beirer, Sebastian; Sejio, Fernando; Suarez, Esther; Lozano, Beatriz; Haegelen, Claire; Vérin, Marc; Porta, Mauro; Servello, Domenico; Gill, Steven; Whone, Alan; Van Dyck, Nic; Alesch, Francois

    2015-07-01

    High-frequency deep brain stimulation (DBS) with a single electrical source is effective for motor symptom relief in patients with Parkinson's disease. We postulated that a multiple-source, constant-current device that permits well defined distribution of current would lead to motor improvement in patients with Parkinson's disease. We did a prospective, multicentre, non-randomised, open-label intervention study of an implantable DBS device (the VANTAGE study) at six specialist DBS centres at universities in six European countries. Patients were judged eligible if they were aged 21-75 years, had been diagnosed with bilateral idiopathic Parkinson's disease with motor symptoms for more than 5 years, had a Hoehn and Yahr score of 2 or greater, and had a Unified Parkinson's disease rating scale part III (UPDRS III) score in the medication-off state of more than 30, which improved by 33% or more after a levodopa challenge. Participants underwent bilateral implantation in the subthalamic nucleus of a multiple-source, constant-current, eight-contact, rechargeable DBS system, and were assessed 12, 26, and 52 weeks after implantation. The primary endpoint was the mean change in UPDRS III scores (assessed by site investigators who were aware of the treatment assignment) from baseline (medication-off state) to 26 weeks after first lead implantation (stimulation-on, medication-off state). This study is registered with ClinicalTrials.gov, number NCT01221948. Of 53 patients enrolled in the study, 40 received a bilateral implant in the subthalamic nucleus and their data contributed to the primary endpoint analysis. Improvement was noted in the UPDRS III motor score 6 months after first lead implantation (mean 13·5 [SD 6·8], 95% CI 11·3-15·7) compared with baseline (37·4 [8·9], 34·5-40·2), with a mean difference of 23·8 (SD 10·6; 95% CI 20·3-27·3; p<0·0001). One patient died of pneumonia 24 weeks after implantation, which was judged to be unrelated to the procedure

  2. 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

  3. 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

  4. [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.

  5. 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),

  6. Validation of sentinel lymph node biopsy in breast cancer women N1-N2 with complete axillary response after neoadjuvant chemotherapy. Multicentre study in Tarragona.

    Science.gov (United States)

    Carrera, D; de la Flor, M; Galera, J; Amillano, K; Gomez, M; Izquierdo, V; Aguilar, E; López, S; Martínez, M; Martínez, S; Serra, J M; Pérez, M; Martin, L

    2016-01-01

    The aim of our study was to evaluate sentinel lymph node biopsy as a diagnostic test for assessing the presence of residual metastatic axillary lymph nodes after neoadjuvant chemotherapy, replacing the need for a lymphadenectomy in negative selective lymph node biopsy patients. A multicentre, diagnostic validation study was conducted in the province of Tarragona, on women with T1-T3, N1-N2 breast cancer, who presented with a complete axillary response after neoadjuvant chemotherapy. Study procedures consisted of performing an selective lymph node biopsy followed by lymphadenectomy. A total of 53 women were included in the study. Surgical detection rate was 90.5% (no sentinel node found in 5 patients). Histopathological analysis of the lymphadenectomy showed complete disease regression of axillary nodes in 35.4% (17/48) of the patients, and residual axillary node involvement in 64.6% (31/48) of them. In lymphadenectomy positive patients, 28 had a positive selective lymph node biopsy (true positive), while 3 had a negative selective lymph node biopsy (false negative). Of the 28 true selective lymph node biopsy positives, the sentinel node was the only positive node in 10 cases. All lymphadenectomy negative cases were selective lymph node biopsy negative. These data yield a sensitivity of 93.5%, a false negative rate of 9.7%, and a global test efficiency of 93.7%. Selective lymph node biopsy after chemotherapy in patients with a complete axillary response provides valid and reliable information regarding axillary status after neoadjuvant treatment, and might prevent lymphadenectomy in cases with negative selective lymph node biopsy. Copyright © 2016 Elsevier España, S.L.U. and SEMNIM. All rights reserved.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study.

    Science.gov (United States)

    Passardi, Alessandro; Rizzo, Mimma; Maines, Francesca; Tondini, Carlo; Zambelli, Alberto; Vespignani, Roberto; Andreis, Daniele; Massa, Ilaria; Dianti, Marco; Forti, Stefano; Piras, Enrico Maria; Eccher, Claudio

    2017-05-29

    Despite the growing number of oral agents available for cancer treatment, their efficacy may be reduced due to the lack of adherence, inappropriate adverse event self-management and arbitrary dose adjustment. The management of anticancer therapies could exponentially benefit from the introduction of mobile health technologies in a highly integrated electronic oncology system. We plan to customise and fine-tune an existing monitoring TreC platform used in different chronic diseases in the oncology setting. This project follows a multistep approach with two major purposes: 1. participatory design techniques driven by Health Literacy and Patient Reported Outcomes principles in order to adapt the system to the oncology setting involving patients and healthcare providers; 2. a prospective training-validation, interventional, non-pharmacological, multicentre study on a series of consecutive patients with cancer (20 and 60 patients in the training and validation steps, respectively) in order to assess system capability, usability and acceptability. The novel Onco-TreC 2.0 is expected to contribute to improving the adherence and safety of cancer care, promoting patient empowerment and patient-doctor communication. Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol Number 2549/2015; reference Number 1315-PU). Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. ClinicalTrials.gov (NCT02921724); (Pre-results). Other study ID Number: IRST100.18. © 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.

  13. 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.

  14. Differential Item Functioning in the SF-36 Physical Functioning and Mental Health Sub-Scales: A Population-Based Investigation in the Canadian Multicentre Osteoporosis Study.

    Science.gov (United States)

    Lix, Lisa M; Wu, Xiuyun; Hopman, Wilma; Mayo, Nancy; Sajobi, Tolulope T; Liu, Juxin; Prior, Jerilynn C; Papaioannou, Alexandra; Josse, Robert G; Towheed, Tanveer E; Davison, K Shawn; Sawatzky, Richard

    2016-01-01

    Self-reported health status measures, like the Short Form 36-item Health Survey (SF-36), can provide rich information about the overall health of a population and its components, such as physical, mental, and social health. However, differential item functioning (DIF), which arises when population sub-groups with the same underlying (i.e., latent) level of health have different measured item response probabilities, may compromise the comparability of these measures. The purpose of this study was to test for DIF on the SF-36 physical functioning (PF) and mental health (MH) sub-scale items in a Canadian population-based sample. Study data were from the prospective Canadian Multicentre Osteoporosis Study (CaMos), which collected baseline data in 1996-1997. DIF was tested using a multiple indicators multiple causes (MIMIC) method. Confirmatory factor analysis defined the latent variable measurement model for the item responses and latent variable regression with demographic and health status covariates (i.e., sex, age group, body weight, self-perceived general health) produced estimates of the magnitude of DIF effects. The CaMos cohort consisted of 9423 respondents; 69.4% were female and 51.7% were less than 65 years. Eight of 10 items on the PF sub-scale and four of five items on the MH sub-scale exhibited DIF. Large DIF effects were observed on PF sub-scale items about vigorous and moderate activities, lifting and carrying groceries, walking one block, and bathing or dressing. On the MH sub-scale items, all DIF effects were small or moderate in size. SF-36 PF and MH sub-scale scores were not comparable across population sub-groups defined by demographic and health status variables due to the effects of DIF, although the magnitude of this bias was not large for most items. We recommend testing and adjusting for DIF to ensure comparability of the SF-36 in population-based investigations.

  15. 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.

  16. 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.

  17. Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

    Science.gov (United States)

    Liu, Zongjun; Shen, Li; Huang, Weijian; Zhao, Xianxian; Fang, Weiyi; Wang, Changqian; Yin, Zhaofang; Wang, Jianan; Fu, Guosheng; Liu, Xuebo; Jiang, Jianjun; Zhang, Zhihui; Li, Jingbo; Lu, Yingmin; Ge, Junbo

    2017-09-01

    Available data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy. This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population. All participants will provide informed consent; the study protoc