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Sample records for afinos study protocol

  1. Physical activity as a preventive measure against overweight, obesity, infections, allergies and cardiovascular disease risk factors in adolescents: AFINOS Study protocol

    Directory of Open Access Journals (Sweden)

    Calle María E

    2009-12-01

    Full Text Available Abstract Background Prior studies addressing the impacts of regular physical activity or sedentary habits on the immune system have been conducted in adults and laboratory settings. Thus, it is practically unknown how a healthy active lifestyle could affect low-grade inflammation processes, infections or allergies in young persons. The AFINOS Study was designed to determine the relationship between the regular physical activity levels of adolescents and overweight, infection, and allergies along with the presence of metabolic and immunological biomarkers of a deteriorated health status. A further objective of the AFINOS Study is to assess the health status and lifestyle habits of an adolescent population in an effort to identify any protective factors that could be used as preventive measures, since many chronic diseases and their associated co-morbidities often persist from adolescence into adulthood. Methods/Design This study was conducted as three separate sub-studies in three different populations as follows: (a Study 1 was performed on a population sample of adolescents; (b Study 2 on the adolescents' parents; and (c Study 3 on a subset of the adolescents from Study 1. Study 1 assessed health and lifestyle indicators through a questionnaire administered to a representative sample of adolescents from the Madrid Region (n = 2400 aged 13 to 16 years. In Study 2, the parents of the teenagers participating in Study 1 were required to fill out a questionnaire. Finally in Study 3, body composition, physical activity, health-related physical fitness, and blood measurements were determined in a subset (n = 200 of the individuals included in Study 1. Discussion This paper describes the rationale, design, and methodologies used in the AFINOS Study. This multidisciplinary, multicenter study seeks to evaluate several aspects of existing relationships between routine physical activity/sedentary behaviour and several health status markers, specifically

  2. STRAIGHT-A STUDENTS DISLIKE PHYSICAL EDUCATION IN ADOLESCENCE: MYTH OR TRUTH? THE AVENA, AFINOS AND UP&DOWN STUDIES.

    Science.gov (United States)

    Cañadas, Laura; Esteban-Cornejo, Irene; Ortega, Francisco B; Gomez-Martinez, Sonia; Casajús, José Antonio; Cabero, María Jesús; Calle, Maria E; Marcos, Ascensión; Veiga, Oscar L; Martinez-Gomez, David

    2015-07-01

    Objetivo: conocer si a aquellos adolescentes que no les gusta la educación física obtienen mejores resultados en rendimiento académico y cognitivo que sus compañeros. Métodos: los participantes incluyen 4.226 adolescentes de los estudios AVENA, AFINOS y UP&DOWN. El gusto por la educación física se valoró con una escala Likert de 7 puntos. El rendimiento cognitivo se valoró en el estudio AVENA usando la versión española del SRA Test of Educational Ability. El rendimiento académico se valoró en los estudios AFINOS y UP&DOWN con las notas de Matemáticas, Lengua y la media de Lengua y Matemáticas. Resultados: en el estudio AVENA encontramos diferencias en la habilidad verbal entre las chicas a las que no les gustaba la educación física y sus compañeros (P = 0,033). En el estudio AFINOS los chicos a los que no les gustaba la educación física tenían mejores notas en Lengua que sus compañeros (P = 0,024). En el estudio UP&DOWN las chicas a las que no les gustaba la educación física obtuvieron mejores resultados en Lengua y en la media de Lengua y Matemáticas (P < 0,001).

  3. Patterns of sedentary behavior and compliance with public health recommendations in Spanish adolescents: the AFINOS study.

    OpenAIRE

    David Martínez Gómez; Veiga, Oscar L; Belén Zapatera; Verónica Cabanas-Sánchez; Sonia Gomez-Martinez; David Martinez-Hernández; Ascensión Marcos

    2012-01-01

    The aims of the present study were: (i) describe patterns of sedentary behavior in Spanish adolescents; and (ii) determine the proportion of adolescents that do not meet the public health recommendations for sedentary behavior. This study comprised 1,724 Spanish adolescents (882 girls), aged 13 to 16 years. Patterns of sedentary behavior (TV viewing, use of computer games, console games and surfing the Internet) were assessed using the HELENA sedentary behavior questionnaire. The total propor...

  4. Adherence to dietary recommendations among Spanish and immigrant adolescents living in Spain: the AFINOS study

    Directory of Open Access Journals (Sweden)

    Laura Esteban-Gonzalo

    2013-12-01

    Full Text Available Objectives: This study compares the adherence of immigrant and Spanish adolescents residing in the Madrid region (Spain to national dietary recommendations. The factors compared were the consumption of items from the eight basic food groups (vegetables, fruits, bread/cereals, meat, eggs, fish, legumes and milk/dairy products, including the excessive or deficient consumption of eggs, meat and fish. In addition, the evaluation of excessive sweet foods or soft drinks in the diet was also considered. Subsequently, the influence of length of residence on dietary habits was examined. Materials and methods: Self-reported data were collected in a cross-sectional survey conducted over the period November 2007 to February 2008. The study participants were a representative sample of adolescents aged 13 to 17 years (n = 2,081, 1,055 girls living in the Madrid region. Participants were recruited from secondary schools (grades 7th to 10th randomly selected according to the geographic distribution of adolescents in the region. Results: Immigrant adolescents showed a greater likelihood of not fulfilling recommendations for the consumption of meat, fish, eggs, legumes, bread/cereals, and milk/dairy products. Their diets were also more likely to lack sufficient fish and they also consumed more eggs and more sweet foods and soft drinks than their native counterparts. Spanish adolescents were more likely not to meet recommendations for the intake of vegetables. Length of residence weakly affected dietary habits, with both negative and positive effects observed. Conclusion: The likelihood of not fulfilling dietary recommendations was higher among the immigrant adolescents with the exception of the intake of fruits and vegetables.

  5. Length of residence and risk of eating disorders in immigrant adolescents living in Madrid: the AFINOS study

    Directory of Open Access Journals (Sweden)

    Laura Esteban-Gonzalo

    2014-05-01

    Full Text Available Objectives: This study was designed to compare the risk of having an eating disorder (ED among immigrant and native adolescents living in Madrid and to determine the possible influence of length of residence (LOR on the risk of the immigrants. Methods: A cross-sectional survey was conducted from november 2007 to february 2008 in a representative sample of adolescents aged 13 to 17 years (n = 2,077, 1,052 girls living in the Madrid region. Data were collected using the Spanish version of the SCOFF Eating Disorders Questionnaire. Further factors considered were country of birth, LOR and several biological, sociodemographic, lifestyle and health-related variables. Results: According to the three logistic regression models constructed, female immigrant adolescents on the whole showed a greater ED risk (OR = 1.95; 95%CI 1.292.95; p = 0.001 than native adolescents. Moreover, the likelihood of ED was higher among female immigrants living in Spain for <6 years than for Spanish native females (OR = 2.44; 95%CI 1.42-4.18; p = 0.001, while no significant differences were found when female natives were compared with female immigrants living in this country for ≥ 6 years. Similarly, no differences were observed in the ED risk recorded for male native and immigrant adolescents, both as a whole and by length of residence in Spain. Conclusions: The immigrant status and the length of Spanish residence are relevant factors in regard to the ED risk in adolescents living in Madrid.

  6. Patterns of sedentary behavior and compliance with public health recommendations in Spanish adolescents: the AFINOS study Patrones de sedentarismo y cumplimiento de las recomendaciones de salud pública en adolescentes españoles: estudio AFINOS

    Directory of Open Access Journals (Sweden)

    David Martínez Gómez

    2012-12-01

    Full Text Available The aims of the present study were: (i describe patterns of sedentary behavior in Spanish adolescents; and (ii determine the proportion of adolescents that do not meet the public health recommendations for sedentary behavior. This study comprised 1,724 Spanish adolescents (882 girls, aged 13 to 16 years. Patterns of sedentary behavior (TV viewing, use of computer games, console games and surfing the Internet were assessed using the HELENA sedentary behavior questionnaire. The total proportion of adolescents watching TV, using computer and console games, and surfing the internet for more than two hours daily was 24%, 9%, 7%, and 17%, respectively, on weekdays, and 50%, 22%, 16%, and 35%, respectively, on weekends. Over 63% of the adolescents from the study did not meet the recommendation for sedentary behavior (Los objetivos del estudio son: (i describir los patrones de comportamiento sedentario en adolescentes españoles y (ii establecer cuántos de ellos no cumplen las recomendaciones de salud pública sobre comportamiento sedentario. Participaron 1.724 adolescentes españoles (882 chicas entre 13 y 16 años. Los patrones de comportamiento sedentario (ver la televisión, juegos de ordenador, videojuegos y navegar en Internet fueron evaluados a través del cuestionario HELENA. La proporción total de adolescentes que ven la TV, usan juegos de ordenador o de consola y navegan en Internet durante > 2h los días de diario fue del 24%, 9%, 7% y 17%, respectivamente. Durante los fines de semana, la proporción fue del 50%, 22%, 16% y 35%. Más del 63% del total de la muestra no cumplen las recomendaciones de tiempo sedentario total < 2 horas durante los días de diario y el 87% no lo hace en días del fin de semana. Dado que las conductas sedentarias podrían ser relevantes en la salud de los adolescentes, las intervenciones de salud pública son necesarias en España.

  7. Study protocol

    DEFF Research Database (Denmark)

    Thorsteinsson, Troels; Helms, Anne Sofie; Adamsen, Lis;

    2013-01-01

    of first-line cancer therapy. Secondary endpoints are quality of life measured by validated questionnaires and interviews, and physical performance. RESPECT includes a multimodal intervention program, including ambassador-facilitated educational, physical, and social interventions. The educational......Background During cancer treatment children have reduced contact with their social network of friends, and have limited participation in education, sports, and leisure activities. During and following cancer treatment, children describe school related problems, reduced physical fitness......, and problems related to interaction with peers. Methods/design The RESPECT study is a nationwide population-based prospective, controlled, mixed-methods intervention study looking at children aged 6-18 years newly diagnosed with cancer in eastern Denmark (n = 120) and a matched control group in western Denmark...

  8. Study protocol

    DEFF Research Database (Denmark)

    Madsen, Helle Østergaard; Dam, Ole Henrik; Hageman, Ida

    2012-01-01

    yields a Global Seasonal Score and a prevalence of SAD. Outcomes from the two groups will be compared. Moreover, outcomes from subgroups of the visually impaired population will be compared. ETHICS AND DISSEMINATION: The study is approved by the Danish Data Protection Agency. Results will be published...... in persons with severe visual impairments or blindness and to compare the results to a control group without visual impairments. Moreover, the authors wish to investigate whether SAD is correlated to the degree of impairment or to the diagnosis. METHODS AND ANALYSIS: 2781 persons with visual impairments...

  9. The DOMUS study protocol

    DEFF Research Database (Denmark)

    Nordly, Mie; Benthien, Kirstine Skov; Von Der Maase, Hans;

    2014-01-01

    is a controlled randomized clinical trial with a balanced parallel-group randomization (1:1). The planned sample size is 340 in- and outpatients treated at the Department of Oncology at Copenhagen University Hospital. Patients are randomly assigned either to: a) standard care plus SPC enriched with a...... cancer can be a powerful tool to improve patients' quality of life and support family/caregivers during the disease trajectory. The present study offers a model for achieving optimal delivery of palliative care in the patient's preferred place of care and attempt to clarify challenges. TRIAL REGISTRATION...

  10. Universal protocol for alopecia areata clinical studies.

    Science.gov (United States)

    Mesinkovska, Natasha A; Bergfeld, Wilma F

    2013-12-01

    Within the area of alopecia areata research, there is an obvious need for well-designed clinical trials of therapeutic agents. The National Alopecia Areata Foundation (NAAF) has created an initiative for the development of a unified protocol with guidelines for clinical studies. The NAAF universal protocol represents a joint effort of clinicians and investigators with experience in treating alopecia areata. This protocol will serve as a tremendous resource to facilitate future clinical studies. PMID:24326554

  11. Security Protocol Design: A Case Study Using Key Distribution Protocols

    Directory of Open Access Journals (Sweden)

    Reiner Dojen

    2009-10-01

    Full Text Available Nowadays security protocols are a key component in providing security services for fixed and mobile networks. These services include data confidentiality, radio link encryption, message integrity, mobile subscriber authentication, electronic payment, certified e-mail, contract signing and nonrepudiation. This paper is concerned with design of effective security protocols. Security protocols are introduced and some common attacks against security protocols are discussed. The vulnerabilities that lead to theattacks are analyzed and guidelines for effective security protocol design are proposed. The presented guidelines are applied to the Andrew Secure RPC protocol and its adapted versions. It is demonstrated that compliance with the guidelines successfully avoidsfreshness and parallel session attacks.

  12. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research...... (rigorous) protocol writing too troublesome, will realize that they have already written the first half of the final paper if they follow these recommendations; authors simply need to change the protocols future tense into past tense. Thus, the aim of this clinical commentary is to describe and explain...

  13. Evaluating Computer-Tutors: A Protocol Study.

    Science.gov (United States)

    Strickland, James

    A protocol study investigated whether computer tutors (programs that interactively guide writers while they freewrite with a word processing program) promote or hinder a richer understanding of the composing process. The analysis focused on writers' attitudes toward computer tutors in the invention process. Data were collected by tape recording a…

  14. Self Fault-Tolerance of Protocols: A Case Study

    Institute of Scientific and Technical Information of China (English)

    2000-01-01

    The prerequisite for the existing protocols' correctness is that protocols can be normally operated under the normal conditions, rather than dealing with abnormal conditions.In other words, protocols with the fault-tolerance can not be provided when some fault occurs. This paper discusses the self fault-tolerance of protocols. It describes some concepts and methods for achieving self fault tolerance of protocols. Meanwhile, it provides a case study, investigates a typical protocol that does not satisfy the self fault-tolerance, and gives a new redesign version of this existing protocol using the proposed approach.

  15. A Study on Merits and Demerits of SAN Protocols

    OpenAIRE

    ASHUTOSH KUMAR SINGH

    2016-01-01

    This paper focuses on SAN protocols and their various topologies, protocol layers, addresses. This article gives the description of rules and regulation of SAN that work in networks of storage. This study paper deals with the study of SAN and DAS, how they work in the open industrial network. This paper surveys on protocols and their working in storage. DAS have SATA, SCSI and SAN have uses FC, FCOE protocols.

  16. [The research protocol IV: study variables].

    Science.gov (United States)

    Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The variables in a research study are all that is measured, the information collected, or the data that is collected in order to answer the research questions, which are specified in the objectives. Their selection is essential to the research protocol. This article aims to point out the elements to be considered in the section of the variables. To avoid ambiguity, it is necessary to select only those that will help achieve the study objectives. It should subsequently be defined how they will be measured to ensure that the findings can be replicated; it is therefore desirable to include conceptual and operational definitions. From the methodological point of view, the classification of variables helps us understand how the relationship between them is conceptualized. Depending on the study design, the independent, dependent, universal, and confounding variables should be noted. Another indispensable element for planning statistical analyses is the scale of variable measurement. Therefore, one must specify whether the variables correspond to one of the following four: qualitative nominal, qualitative ordinal, quantitative range, or quantitative ratio. Finally, we should detail the measurement units of each variable. PMID:27560918

  17. Mac protocols for wireless sensor network (wsn): a comparative study

    International Nuclear Information System (INIS)

    Data communication between nodes is carried out under Medium Access Control (MAC) protocol which is defined at data link layer. The MAC protocols are responsible to communicate and coordinate between nodes according to the defined standards in WSN (Wireless Sensor Networks). The design of a MAC protocol should also address the issues of energy efficiency and transmission efficiency. There are number of MAC protocols that exist in the literature proposed for WSN. In this paper, nine MAC protocols which includes S-MAC, T-MAC, Wise-MAC, Mu-MAC, Z-MAC, A-MAC, D-MAC, B-MAC and B-MAC+ for WSN have been explored, studied and analyzed. These nine protocols are classified in contention based and hybrid (combination of contention and schedule based) MAC protocols. The goal of this comparative study is to provide a basis for MAC protocols and to highlight different mechanisms used with respect to parameters for the evaluation of energy and transmission efficiency in WSN. This study also aims to give reader a better understanding of the concepts, processes and flow of information used in these MAC protocols for WSN. A comparison with respect to energy reservation scheme, idle listening avoidance, latency, fairness, data synchronization, and throughput maximization has been presented. It was analyzed that contention based MAC protocols are less energy efficient as compared to hybrid MAC protocols. From the analysis of contention based MAC protocols in term of energy consumption, it was being observed that protocols based on preamble sampling consume lesser energy than protocols based on static or dynamic sleep schedule. (author)

  18. Interactive verification of Markov chains: Two distributed protocol case studies

    Directory of Open Access Journals (Sweden)

    Johannes Hölzl

    2012-12-01

    Full Text Available Probabilistic model checkers like PRISM only check probabilistic systems of a fixed size. To guarantee the desired properties for an arbitrary size, mathematical analysis is necessary. We show for two case studies how this can be done in the interactive proof assistant Isabelle/HOL. The first case study is a detailed description of how we verified properties of the ZeroConf protocol, a decentral address allocation protocol. The second case study shows the more involved verification of anonymity properties of the Crowds protocol, an anonymizing protocol.

  19. Study Application of RADIUS Protocol on Ethernet

    Institute of Scientific and Technical Information of China (English)

    GUO Fang; YANG Huan-yu; LI Hong

    2004-01-01

    This paper presents how to apply the RADIUS (Remote Authentication Dial In User Service)protocol ,which is generally applied to dial-up network, to the authentication & charge of Broad Band accessing control system on Ethernet. It is provided that the Broad Band accessing control system included a self-designed communication protocol is used in communicating between an terminal user and Network Access Server .The interface module on the servers side and the Radius system is also given in this article.

  20. Studying Media Access andControl Protocols

    OpenAIRE

    Mohammed, Alalelddin Fuad Yousif

    2010-01-01

    This thesis project’s goal is to enable undergraduate students to gain insight into media access and control protocols based upon carrying out laboratory experiments. The educational goal is to de-mystifying radio and other link and physical layer communication technologies as the students can follow packets from the higher layers down through the physical layer and back up again. The thesis fills the gap between the existing documentation for the Universal Software Radio Peripheral (USRP) re...

  1. Adherence to dietary recommendations among Spanish and immigrant adolescents living in Spain; the AFINOS study.

    Science.gov (United States)

    Esteban-Gonzalo, Laura; Veiga, Oscar Luis; Gómez-Martínez, Sonia; Regidor, Enrique; Martínez, David; Marcos, Ascensión; Calle, María Elisa

    2013-11-01

    Objetivos: Este estudio compara la adherencia a las recomendaciones nutricionales de adolescentes inmigrantes y españoles residentes en la Comunidad de Madrid, España. Se comparó el consumo de ocho grupos principales de alimentos (verduras, frutas, pan/cereales, carne, huevos, pescado, legumbres, leche/derivados lácteos) incluyendo el consumo excesivo y deficiente de huevos, carne y pescado. También fue valorado el consumo excesivo de dulces y bebidas azucaradas. Posteriormente se analizó la influencia del tiempo de residencia en España sobre los mencionados hábitos de dieta. Material y método: Se llevó a cabo un estudio transversal en el que fueron recogidos datos auto-reportados durante el periodo comprendido entre Noviembre 2007 y Febrero 2008. Se obtuvo una muestra representativa de adolescentes con edades comprendidas entre 13 y 17 años (n=2081, 1055 mujeres) residentes en la Comunidad de Madrid. Los participantes pertenecían a centros de enseñanza secundaria seleccionados aleatoriamente según la distribución geográfica de los adolescentes en la región. Resultados: Los inmigrantes adolescentes presentaron una mayor probabilidad de no cumplir las recomendaciones nutricionales para el consume de carne, pescado, legumbres, pan/cereales y leche/derivados, de consumir una cantidad insuficiente de pescado y más dulces y bebidas azucaradas que sus compañeros españoles. Los adolescentes españoles mostraron una mayor probabilidad de no cumplir con la recomendación establecida para verduras. El tiempo de residencia afectó débilmente los hábitos de dieta, asociando aspectos tanto positivos como negativos. Conclusiones: La probabilidad de no cumplir las recomendaciones nutricionales fue mayor entre los adolescentes inmigrantes con excepción del consumo de frutas y verduras.

  2. Extraction protocols for orthodontic treatment: A retrospective study

    Science.gov (United States)

    Thirunavukkarasu, Vaishnevi N.; Ramachandra, Srinivas Sulugodu; Dicksit, Daniel D.; Gundavarapu, Kalyan C.

    2016-01-01

    Background and Objectives: Various extraction protocols have been followed for successful orthodontic treatment. The purpose of this study was to evaluate the extraction protocols in patients who had previously undergone orthodontic treatment and also who had reported for continuing orthodontic treatment from other clinics. Materials and Methods: One hundred thirty eight patients who registered for orthodontic treatment at the Faculty of Dentistry were divided into 10 extraction protocols based on the Orthodontic treatment protocol given by Janson et al. and were evaluated for statistical significance. Results: The descriptive statistics of the study revealed a total of 40 (29%) patients in protocol 1, 43 (31.2%) in protocol 2, 18 (13%) in protocol 3, 16 (11.6%) in protocol 5, and 12 (8.7%) in Type 3 category of protocol 9. The Type 3 category in protocol 9 was statistically significant compared to other studies. Midline shift and collapse of the arch form were noticed in these individuals. Conclusion: Extraction of permanent teeth such as canine and lateral incisors without rational reasons could have devastating consequences on the entire occlusion. The percentage of cases wherein extraction of permanent teeth in the crowded region was adopted as a treatment option instead of orthodontic treatment is still prevalent in dental practice. The shortage of orthodontists in Malaysia, the long waiting period, and lack of subjective need for orthodontic treatment at an earlier age group were the reasons for the patient's to choose extraction of the mal-aligned teeth such as the maxillary canine or maxillary lateral incisors. PMID:27041899

  3. SIMULATION STUDY AND IMPLEMENTATION ON ROUTING PROTOCOLS IN MANET

    Directory of Open Access Journals (Sweden)

    Anju Yadav

    2012-09-01

    Full Text Available Ad-hoc networks are characterized by a lack of infrastructure, and by a random and quickly changing network topology; thus the need for a robust dynamic routing protocol that can accommodate such an environment. Consequently, many routing algorithms have come in toexistence to satisfy the needs of communications in such networks. This article presents a simulation study and comparison the performance between two categories of routing protocols, table-driven (Proactive and on-demand (Reactive routing protocols, this two categories were illustrated by using two different examples ofrouting protocols, first example is DSDV (Destination Sequenced Distance-Vector from the Proactive family and the second example isAODV (Ad Hoc On-Demand Distance Vector and DSR (Dynamic Source Routing Protocol from the Reactive family. Both protocols weresimulated by using NS-2 (network simulator-2 package. Both routing protocols were compared in terms of average throughput (packets delivery ratio while varying data rate, TCP types ,maximumpackets in queue and number of packet drop while varying data rate by using the Trace file. For the same queue length DSDV performsbetter than AODV. AODV is preferred due to its more efficient use of bandwidth.

  4. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research to qu...

  5. A parathyroid adenoma case study: Protocol review

    International Nuclear Information System (INIS)

    Full text: Technetium-99m (99mTc) Sestamibi as opposed to Thallous-201 Chloride and 99mTc Sodium Pertechnetate subtraction, has become the radiopharmaceutical of choice for detection of parathyroid adenomas. A 17-year-old female patient presented to the department for a parathyroid 99mTc Sestamibi scan to evaluate possible parathyroid adenoma/s. She was initially admitted with increasing serum Calcium levels, polyuria, abdominal pain and general malaise. The patient was injected with 900MBq of 99mTc Sestamibi, and a pinhole dynamic at a distance of 10 cm from the neck was acquired followed by a 5-minute static image at 7 cm. Single Photon Emission Computed Tomography (SPECT) was then performed on a dual-head gamma camera followed by an anterior and posterior 10-minute static image. At 3 and 5 hours post injection the 10-minute static image was repeated. This study was reported as normal with uniform uptake and washout of the tracer over the 5-hour period. An ultrasound study was performed, and it showed a lesion believed to be a parathyroid adenoma measuring 2.2 x 0.8 x 0.4 cm in size in the right upper lobe of the thyroid. A subsequent thyroid scan was performed to confirm that it was non-functioning thyroid tissue. The patient was injected with 250MBq of 99mTc Sodium Pertechnetate and scanned with a pinhole collimator at a distance of 7 cm. When the 99mTc Sestamibi and 99mTc Sodium Pertechnetate scan were viewed together, it was clear that there was excess 99mTc Sestamibi distribution on the right upper lobe of the thyroid, which washed out over time. This corresponded to the ultrasound findings and was confirmed at surgery to be a parathyroid adenoma. A 99mTc Sodium Pertechnetate scan and an ultrasound are now also routinely performed on patients presenting for 99mTc Sestamibi parathyroid scans

  6. Studies on Algorithms for Self-Stabilizing Communication Protocols

    Institute of Scientific and Technical Information of China (English)

    LI Layuan; LI Chunlin

    1999-01-01

    In this paper the algorithms forself-stabilizing communication protocols are studied. First someconcepts and a formal method for describing the proposed algorithms aredescribed, then an improved algorithm for achieving global states ispresented. Thestudy shows that the improved algorithm can be applied to obtain the globalstates in the case of a loss of cooperation of the different processesin the protocol, which can be used as a recovery point that will be usedby the following recovery procedure. Thus, the improved algorithm can beused to self-stabilize a communication protocol. Meanwhile,a recovery algorithm for self-stabilizing communicationprotocols is presented. After a failure is detected, all processes caneventuallyknow the error. The recovery algorithm uses the contextual information exchanged during the progress of the protocol and recorded on the stablememory. The proof of correctness and analysis of complexity for these algorithms have been made. The availability and efficiency of the algorithms have been verified by illustrating the example protocols.Finally, some conclusions and remarks are given.

  7. A Quantitative Study and Comparison of Secure OLSR Routing Protocol

    Directory of Open Access Journals (Sweden)

    S.Tamilarasan

    2012-03-01

    Full Text Available This paper presents the comparison of thesecure OLSR (Optimized Link State RoutingProtocol in mobile ad-hoc network with otherapproach. We compare the security from thedifferent approach and their effect on the existingOLSR. The Main aim of this paper is to study thevarious securities and compare the different attacksin MANET. Different approaches uses differentcryptography security scheme and trying to providethe security to OLSR routing protocols. We alsoconcern the different possible attacks on the OLSRand check that which security scheme is better toprovide the security from the attacks.

  8. Boosting bioluminescence neuroimaging: an optimized protocol for brain studies.

    Science.gov (United States)

    Aswendt, Markus; Adamczak, Joanna; Couillard-Despres, Sebastien; Hoehn, Mathias

    2013-01-01

    Bioluminescence imaging is widely used for optical cell tracking approaches. However, reliable and quantitative bioluminescence of transplanted cells in the brain is highly challenging. In this study we established a new bioluminescence imaging protocol dedicated for neuroimaging, which increases sensitivity especially for noninvasive tracking of brain cell grafts. Different D-Luciferin concentrations (15, 150, 300 and 750 mg/kg), injection routes (i.v., i.p., s.c.), types of anesthesia (Isoflurane, Ketamine/Xylazine, Pentobarbital) and timing of injection were compared using DCX-Luc transgenic mice for brain specific bioluminescence. Luciferase kinetics was quantitatively evaluated for maximal photon emission, total photon emission and time-to-peak. Photon emission followed a D-Luciferin dose-dependent relation without saturation, but with delay in time-to-peak increasing for increasing concentrations. The comparison of intravenous, subcutaneous and intraperitoneal substrate injection reflects expected pharmacokinetics with fastest and highest photon emission for intravenous administration. Ketamine/Xylazine and Pentobarbital anesthesia showed no significant beneficial effect on maximal photon emission. However, a strong difference in outcome was observed by injecting the substrate pre Isoflurane anesthesia. This protocol optimization for brain specific bioluminescence imaging comprises injection of 300 mg/kg D-Luciferin pre Isoflurane anesthesia as an efficient and stable method with a signal gain of approx. 200% (compared to 150 mg/kg post Isoflurane). Gain in sensitivity by the novel imaging protocol was quantitatively assessed by signal-to-noise calculations of luciferase-expressing neural stem cells grafted into mouse brains (transplantation of 3,000-300,000 cells). The optimized imaging protocol lowered the detection limit from 6,000 to 3,000 cells by a gain in signal-to-noise ratio.

  9. A comparative study of protocols for secure quantum communication under noisy environment: single-qubit-based protocols versus entangled-state-based protocols

    Science.gov (United States)

    Sharma, Vishal; Thapliyal, Kishore; Pathak, Anirban; Banerjee, Subhashish

    2016-07-01

    The effect of noise on various protocols of secure quantum communication has been studied. Specifically, we have investigated the effect of amplitude damping, phase damping, squeezed generalized amplitude damping, Pauli type as well as various collective noise models on the protocols of quantum key distribution, quantum key agreement, quantum secure direct quantum communication and quantum dialogue. From each type of protocol of secure quantum communication, we have chosen two protocols for our comparative study: one based on single-qubit states and the other one on entangled states. The comparative study reported here has revealed that single-qubit-based schemes are generally found to perform better in the presence of amplitude damping, phase damping, squeezed generalized amplitude damping noises, while entanglement-based protocols turn out to be preferable in the presence of collective noises. It is also observed that the effect of noise depends upon the number of rounds of quantum communication involved in a scheme of quantum communication. Further, it is observed that squeezing, a completely quantum mechanical resource present in the squeezed generalized amplitude channel, can be used in a beneficial way as it may yield higher fidelity compared to the corresponding zero squeezing case.

  10. Comparison Study of Transmission Control Protocol and User Datagram Protocol Behavior over Multi-Protocol Label Switching Networks in Case of Failures

    Directory of Open Access Journals (Sweden)

    Taha A.A Radaei

    2009-01-01

    Full Text Available Problem statement: In only a few years, Multi-Protocol Label Switching (MPLS has evolved from an exotic technology to a mainstream tool used by service providers to create revenue-generating services. MPLS provides a high reliable Label Switched Path (LSP. MPLS failures may degrade the reliability of the MPLS networks. Approach: For that reason, many studies have been conducted to keep the high reliability and survivability of the MPLS networks. Unlike User Datagram Protocol (UDP, Transmission Control Protocol does not perform well in case of like-failure of MPLS networks because of its inability to distinguish packet loss due to link-failure. After the recovery time, TCP takes longer time than UDP to continue as it was before the failure. Results: In terms of packet loss, TCP performs better than UDP. However, the receiving rate of the TCP traffic is much worse than UDP traffic. A need for a mechanism to improve the behavior of TCP after a link failure is needed. This study focused on comparing the behavior of different types TCP as well as UDP traffic over MPLS networks in case of link, node or congestion failures. Conclusion: Although extensions of RSVP-TE protocol support fast recovery mechanism of MPLS networks, the behavior of TCP will be affected during recovery time much more than with UDP.

  11. Study and Improvement of WTLS Protocol in WAP

    Institute of Scientific and Technical Information of China (English)

    CHEN Kai; LIU Ying; XIAO Guozhen

    2001-01-01

    Wireless application protocol (WAP)is a set of protocol designed for mobile terminal toconnect to Internet and is likely to become world stan-dard. Wireless transport layer security (WTLS) incor-porates the security features in WAP. In this paper,the analysis of the performance of WTLS is made.Two improvement schemes on WTLS are given: oneis that the client stores the certificate of servers; theother is that a new WTLS protocol is proposed basedon the designed authentication scheme.

  12. A Comparative Study of Various Routing Protocols in VANET

    OpenAIRE

    Kumar, Rakesh; Dave, Mayank

    2011-01-01

    Vehicular Ad Hoc Networks (VANET) is a subclass of Mobile ad hoc networks which provides a distinguished approach for Intelligent Transport System (ITS). The survey of routing protocols in VANET is important and necessary for smart ITS. This paper discusses the advantages / disadvantages and the applications of various routing protocols for vehicular ad hoc networks. It explores the motivation behind the designed, and traces the evolution of these routing protocols. F inally the paper conclud...

  13. A Comparative Study of Various Routing Protocols in VANET

    OpenAIRE

    Rakesh Kumar; Mayank Dave

    2011-01-01

    Vehicular Ad Hoc Networks (VANET) is a subclass of Mobile ad hoc networks which provides a distinguished approach for Intelligent Transport System (ITS). The survey of routing protocols in VANET is important and necessary for smart ITS. This paper discusses the advantages / disadvantages and the applications of various routing protocols for vehicular ad hoc networks. It explores the motivation behind the designed, and traces the evolution of these routing protocols. Finally the paper conclude...

  14. A Comparative Study of Various Routing Protocols in VANET

    CERN Document Server

    Kumar, Rakesh

    2011-01-01

    Vehicular Ad Hoc Networks (VANET) is a subclass of Mobile ad hoc networks which provides a distinguished approach for Intelligent Transport System (ITS). The survey of routing protocols in VANET is important and necessary for smart ITS. This paper discusses the advantages / disadvantages and the applications of various routing protocols for vehicular ad hoc networks. It explores the motivation behind the designed, and traces the evolution of these routing protocols. F inally the paper concludes by a tabular comparison of the various routing protocols for VANET.

  15. Recommended Protocol for Round Robin Studies in Additive Manufacturing

    Science.gov (United States)

    Moylan, Shawn; Brown, Christopher U.; Slotwinski, John

    2016-01-01

    One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST’s experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed. PMID:27274602

  16. The bakery protocol : a comparitive case-study in formal verification

    NARCIS (Netherlands)

    Griffioen, W.O.D.; Korver, H.P.

    1995-01-01

    A Comparative Case-Study in Formal Verification Groote and the second author verified (a version of) the Bakery Protocol in $muCRL$. Their process-algebraic verification is rather complex compared to the protocol. Now the question is: How do other verification techniques perform on this protocol? In

  17. Mobile Ad Hoc Networks: A Comparative Study of QoS Routing Protocols

    CERN Document Server

    Gangwar, Sanjeev; Kumar, Krishan

    2012-01-01

    This Article presents a thorough overview of QoS routing metrics, resources and factors affecting performance of QoS routing protocols. The relative strength, weakness, and applicability of existing QoS routing protocols are also studied and compared. QoS routing protocols are classified according to the QoS metrics used type of QoS guarantee assured.

  18. Study protocol: The Intensive Care Outcome Network ('ICON' study

    Directory of Open Access Journals (Sweden)

    Barber Vicki S

    2008-06-01

    Full Text Available Abstract Background Extended follow-up of survivors of ICU treatment has shown many patients suffer long-term physical and psychological consequences that affect their health-related quality of life. The current lack of rigorous longitudinal studies means that the true prevalence of these physical and psychological problems remains undetermined. Methods/Design The ICON (Intensive Care Outcome Network study is a multi-centre, longitudinal study of survivors of critical illness. Patients will be recruited prior to hospital discharge from 20–30 ICUs in the UK and will be assessed at 3, 6, and 12 months following ICU discharge for health-related quality of life as measured by the Short Form-36 (SF-36 and the EuroQoL (EQ-5D; anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS; and post traumatic stress disorder (PTSD symptoms as measured by the PTSD Civilian Checklist (PCL-C. Postal questionnaires will be used. Discussion The ICON study will create a valuable UK database detailing the prevalence of physical and psychological morbidity experienced by patients as they recover from critical illness. Knowledge of the prevalence of physical and psychological morbidity in ICU survivors is important because research to generate models of causality, prognosis and treatment effects is dependent on accurate determination of prevalence. The results will also inform economic modelling of the long-term burden of critical illness. Trial Registration ISRCTN69112866

  19. RPL Routing Protocol a case study: Precision agriculture

    OpenAIRE

    Chen, Y.; Chanet, J.P.; K. M. Hou

    2012-01-01

    International audience The routing protocol for low power and lossy network (RPL) was designed in the ROLL working group at IETF since the year of 2008. Until the latest version of draft 19 released, this protocol algorithms and its four application scenario, such as home automation, industrial control, urban environment and building automation, have been nearly grounded. However, it is still very difficult to find effective approaches to simulate and evaluate RPL's behavior and other exte...

  20. STUDY OF VANET ROUTING PROTOCOLS FOR END TO END DELAY

    Directory of Open Access Journals (Sweden)

    Sunilkumar M. Bhagat

    2013-02-01

    Full Text Available Less than a century since the automobile was made affordable enough for the general public, hundreds of millions of vehicles now travel along highways and streets around the world. Innovations in safety, comfort, and convenience have made vast improvements in automobiles during that time, and now new technologies promise to change the face of vehicular travel once again. Vehicular ad hoc network (VANET is network which provides the communication between vehicle to vehicle for p r o v i d i n g i n f o r m a t i o n t o travelers with new features and applications that have never previously been possible. This paper focuses on vehicle to vehicle (V2V communications in VANET. Lot of research is going on for determining route between source and destination vehicles for routing the information with good packet delivery ratio. In this paper we provide a simulation and study of VANET Routing Protocols for end-to-end delay in V2V communication.

  1. A protocol for conducting rainfall simulation to study soil runoff.

    Science.gov (United States)

    Kibet, Leonard C; Saporito, Louis S; Allen, Arthur L; May, Eric B; Kleinman, Peter J A; Hashem, Fawzy M; Bryant, Ray B

    2014-04-03

    Rainfall is a driving force for the transport of environmental contaminants from agricultural soils to surficial water bodies via surface runoff. The objective of this study was to characterize the effects of antecedent soil moisture content on the fate and transport of surface applied commercial urea, a common form of nitrogen (N) fertilizer, following a rainfall event that occurs within 24 hr after fertilizer application. Although urea is assumed to be readily hydrolyzed to ammonium and therefore not often available for transport, recent studies suggest that urea can be transported from agricultural soils to coastal waters where it is implicated in harmful algal blooms. A rainfall simulator was used to apply a consistent rate of uniform rainfall across packed soil boxes that had been prewetted to different soil moisture contents. By controlling rainfall and soil physical characteristics, the effects of antecedent soil moisture on urea loss were isolated. Wetter soils exhibited shorter time from rainfall initiation to runoff initiation, greater total volume of runoff, higher urea concentrations in runoff, and greater mass loadings of urea in runoff. These results also demonstrate the importance of controlling for antecedent soil moisture content in studies designed to isolate other variables, such as soil physical or chemical characteristics, slope, soil cover, management, or rainfall characteristics. Because rainfall simulators are designed to deliver raindrops of similar size and velocity as natural rainfall, studies conducted under a standardized protocol can yield valuable data that, in turn, can be used to develop models for predicting the fate and transport of pollutants in runoff.

  2. Protocol: optimisation of a grafting protocol for oilseed rape (Brassica napus) for studying long-distance signalling

    OpenAIRE

    Ostendorp, Anna; Pahlow, Steffen; Deke, Jennifer; Thieß, Melanie; Kehr, Julia

    2016-01-01

    Background Grafting is a well-established technique for studying long-distance transport and signalling processes in higher plants. While oilseed rape has been the subject of comprehensive analyses of xylem and phloem sap to identify macromolecules potentially involved in long-distance information transfer, there is currently no standardised grafting method for this species published. Results We developed a straightforward collar-free grafting protocol for Brassica napus plants with high repr...

  3. Comparative Study on Various Authentication Protocols in Wireless Sensor Networks.

    Science.gov (United States)

    Rajeswari, S Raja; Seenivasagam, V

    2016-01-01

    Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated. PMID:26881272

  4. Protocol for fir tree sampling for provenance studies

    Science.gov (United States)

    Meisel, Thomas; Bandoniene, Donata; Zettl, Daniela

    2014-05-01

    Isotopic (stable and radiogenic) as well as trace element fingerprinting methods used for tracing the geographical origin, rely on databases, that need to contain data sets representative of the measurands of the individual samples for a specific geographic entity. Through this work, we want to assess different sampling strategies for obtaining representative sample of fir trees (Abies sp.). Motivation for this work is the protection of the local Austrian Christmas tree market from wrongly tagged trees of non-Austrian origin. In particular, we studied three typical Christmas trees the most common species sold as Christmas tree, namely Abies nordmanniana (Nordmann Fir), from the same locality in lower Austria. For the initial tests we applied the elemental fingerprinting method, to study the suitability of the different parts of the tree applying ICP-MS analysis after complete acid digestion in a high pressure asher system (HPA-S).Needle samples from each year of life of the tree and stem wood from three different heights were analyzed for their trace element content to prove the repeatability and to find the best sampling protocol. For the analysis of the needles, the natural wax coating had to be removed in order to get reproducible results. For the analysis of stem wood only the bark was removed. As expected the data of all three trees allowed the differentiation of the individual needle ages, but interestingly enough also between the three sampling heights of the needs. Both needles and wood proved to be suitable for successful fingerprinting, but importantly, provided that sample of the same type and ages are compared. The same samples for the three trees will also be used for isotopic analysis studies to better understand the influence of age and sampling height on the representativeness of fir tree samples. Based on elemental fingerprinting alone, a successful discrimination between local (Austrian) and foreign (Danish, Irish) Christmas trees was possible.

  5. Improving outpatient safety through effective electronic communication: a study protocol

    Directory of Open Access Journals (Sweden)

    Espadas Donna

    2009-09-01

    Full Text Available Abstract Background Health information technology and electronic medical records (EMRs are potentially powerful systems-based interventions to facilitate diagnosis and treatment because they ensure the delivery of key new findings and other health related information to the practitioner. However, effective communication involves more than just information transfer; despite a state of the art EMR system, communication breakdowns can still occur. 123 In this project, we will adapt a model developed by the Systems Engineering Initiative for Patient Safety (SEIPS to understand and improve the relationship between work systems and processes of care involved with electronic communication in EMRs. We plan to study three communication activities in the Veterans Health Administration's (VA EMR: electronic communication of abnormal imaging and laboratory test results via automated notifications (i.e., alerts; electronic referral requests; and provider-to-pharmacy communication via computerized provider order entry (CPOE. Aim Our specific aim is to propose a protocol to evaluate the systems and processes affecting outcomes of electronic communication in the computerized patient record system (related to diagnostic test results, electronic referral requests, and CPOE prescriptions using a human factors engineering approach, and hence guide the development of interventions for work system redesign. Design This research will consist of multiple qualitative methods of task analysis to identify potential sources of error related to diagnostic test result alerts, electronic referral requests, and CPOE; this will be followed by a series of focus groups to identify barriers, facilitators, and suggestions for improving the electronic communication system. Transcripts from all task analyses and focus groups will be analyzed using methods adapted from grounded theory and content analysis.

  6. Pilot study of a paediatric emergency department oral rehydration protocol

    OpenAIRE

    Boyd, R.; Busuttil, M; Stuart, P

    2005-01-01

    Objective: To ascertain if the use of a paediatric oral rehydration protocol in the emergency department changed rates of admission, total time spent in hospital, total time spent in the emergency department, or number of unscheduled returns to the emergency department.

  7. Protocol: using virus-induced gene silencing to study the arbuscular mycorrhizal symbiosis in Pisum sativum

    DEFF Research Database (Denmark)

    Grønlund, Mette; Olsen, Anne; Johansen, Elisabeth;

    2010-01-01

    , the available PEBV-VIGS protocols are inadequate for studying genes involved in the symbiosis with arbuscular mycorrhizal fungi (AMF). Here we describe a PEBV-VIGS protocol suitable for reverse genetics studies in pea of genes involved in the symbiosis with AMF and show its effectiveness in silencing genes...... involved in the early and late stages of AMF symbiosis....

  8. Hypertension Improvement Project (HIP: study protocol and implementation challenges

    Directory of Open Access Journals (Sweden)

    Pollak Kathryn I

    2009-02-01

    Full Text Available Abstract Background Hypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care. Methods and design This paper describes the protocol of a nested 2 × 2 randomized controlled trial to test the separate and combined effects on systolic blood pressure of a behavioral intervention for patients and a quality improvement-type intervention for physicians. Primary care practices were randomly assigned to the physician intervention or to the physician control condition. Physician randomization occurred at the clinic level. The physician intervention included training and performance monitoring. The training comprised 2 internet-based modules detailing both the JNC-7 hypertension guidelines and lifestyle modifications for hypertension. Performance data were collected for 18 months, and feedback was provided to physicians every 3 months. Patient participants in both intervention and control clinics were individually randomized to the patient intervention or to usual care. The patient intervention consisted of a 6-month behavioral intervention conducted by trained interventionists in 20 group sessions, followed by 12 monthly phone contacts by community health advisors. Follow-up measurements were performed at 6 and 18 months. The primary outcome was the mean change in systolic blood pressure at 6 months. Secondary outcomes were diastolic blood pressure and the proportion of patients with adequate blood pressure control at 6 and 18 months. Discussion Overall, 8 practices (4 per treatment group, 32 physicians (4 per practice; 16 per treatment group, and 574 patients (289 control and 285 intervention were enrolled. Baseline characteristics of patients and

  9. A Comparative Study of Key Management Protocols for WSN

    Directory of Open Access Journals (Sweden)

    Seema Verma

    2014-03-01

    Full Text Available Increased employment of WSN (Wireless Sensor Network in real life applications and their hostile and remote locations accelerate demand of security in WSN. Publicly accessible wireless communication channel also makes WSN vulnerable to numerous security attacks. Scarcity of resources acquaints new sort of challenges and difficulties during implementation of effective security mechanisms. In this paper, we evaluate and compare performance of three different security mechanisms (ECRKS, CKP and AP scheme. ECRKS (Energy-efficient, Connected, Resilient Key pre-distribution Scheme is based upon multi hop communication architecture specifically designed for homogeneous WSN. Clustering based protocols, AP (Asymmetric pre-distribution scheme and CKP (Clustering based Key management Protocol are proposed for heterogeneous WSN. All the above mentioned schemes are simulated in MATLAB to evaluate their effectiveness and suitability for WSN. Simulation result shows that CKP outperforms other two schemes in terms of transmission distance, memory burden, energy dissipation and resilience.

  10. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  11. Pilot studies for the North American Soil Geochemical Landscapes Project - Site selection, sampling protocols, analytical methods, and quality control protocols

    Science.gov (United States)

    Smith, D.B.; Woodruff, L.G.; O'Leary, R. M.; Cannon, W.F.; Garrett, R.G.; Kilburn, J.E.; Goldhaber, M.B.

    2009-01-01

    In 2004, the US Geological Survey (USGS) and the Geological Survey of Canada sampled and chemically analyzed soils along two transects across Canada and the USA in preparation for a planned soil geochemical survey of North America. This effort was a pilot study to test and refine sampling protocols, analytical methods, quality control protocols, and field logistics for the continental survey. A total of 220 sample sites were selected at approximately 40-km intervals along the two transects. The ideal sampling protocol at each site called for a sample from a depth of 0-5 cm and a composite of each of the O, A, and C horizons. The Quality control (QC) of the analyses was monitored at three levels: the laboratory performing the analysis, the USGS QC officer, and the principal investigator for the study. This level of review resulted in an average of one QC sample for every 20 field samples, which proved to be minimally adequate for such a large-scale survey. Additional QC samples should be added to monitor within-batch quality to the extent that no more than 10 samples are analyzed between a QC sample. Only Cr (77%), Y (82%), and Sb (80%) fell outside the acceptable limits of accuracy (% recovery between 85 and 115%) because of likely residence in mineral phases resistant to the acid digestion. A separate sample of 0-5-cm material was collected at each site for determination of organic compounds. A subset of 73 of these samples was analyzed for a suite of 19 organochlorine pesticides by gas chromatography. Only three of these samples had detectable pesticide concentrations. A separate sample of A-horizon soil was collected for microbial characterization by phospholipid fatty acid analysis (PLFA), soil enzyme assays, and determination of selected human and agricultural pathogens. Collection, preservation and analysis of samples for both organic compounds and microbial characterization add a great degree of complication to the sampling and preservation protocols and a

  12. Pilot studies for the North American Soil Geochemical Landscapes Project - Site selection, sampling protocols, analytical methods, and quality control protocols

    International Nuclear Information System (INIS)

    In 2004, the US Geological Survey (USGS) and the Geological Survey of Canada sampled and chemically analyzed soils along two transects across Canada and the USA in preparation for a planned soil geochemical survey of North America. This effort was a pilot study to test and refine sampling protocols, analytical methods, quality control protocols, and field logistics for the continental survey. A total of 220 sample sites were selected at approximately 40-km intervals along the two transects. The ideal sampling protocol at each site called for a sample from a depth of 0-5 cm and a composite of each of the O, A, and C horizons. The 3, HClO4, and HF. Separate methods were used for Hg, Se, total C, and carbonate-C on this same size fraction. Only Ag, In, and Te had a large percentage of concentrations below the detection limit. Quality control (QC) of the analyses was monitored at three levels: the laboratory performing the analysis, the USGS QC officer, and the principal investigator for the study. This level of review resulted in an average of one QC sample for every 20 field samples, which proved to be minimally adequate for such a large-scale survey. Additional QC samples should be added to monitor within-batch quality to the extent that no more than 10 samples are analyzed between a QC sample. Only Cr (77%), Y (82%), and Sb (80%) fell outside the acceptable limits of accuracy (% recovery between 85 and 115%) because of likely residence in mineral phases resistant to the acid digestion. A separate sample of 0-5-cm material was collected at each site for determination of organic compounds. A subset of 73 of these samples was analyzed for a suite of 19 organochlorine pesticides by gas chromatography. Only three of these samples had detectable pesticide concentrations. A separate sample of A-horizon soil was collected for microbial characterization by phospholipid fatty acid analysis (PLFA), soil enzyme assays, and determination of selected human and agricultural

  13. Implementing enhanced recovery after bariatric surgery protocol: a retrospective study.

    Science.gov (United States)

    Proczko, Monika; Kaska, Lukasz; Twardowski, Pawel; Stepaniak, Pieter

    2016-02-01

    While the demand for bariatric surgery is increasing, hospital capacity remains limited. The ERABS (Enhanced Recovery After Bariatric Surgery) protocol has been implemented in a number of bariatric centers. We retrospectively compared the operating room logistics and postoperative complications between pre-ERABS and ERABS periods in an academic hospital. The primary endpoint was the length of stay in hospital. The secondary endpoints were turnover times-the time required for preparing the operating room for the next case, induction time (from induction of anesthesia until a patient is ready for surgery), surgical time (duration of surgery), procedure time (duration of stay in the operating room), and the incidence of re-admissions, re-operations and complications during admission and within 30 days after surgery. Of a total of 374 patients, 228 and 146 received surgery following the pre-ERABS and ERABS protocols, respectively. The length of hospital stay was significantly shortened from 3.7 (95 % confidence interval [CI] 3.1-4.7) days to 2.1 (95 % CI 1.6-2.6) days (P surgery, respectively (P < 0.001 for both), by introducing the ERABS protocol. Induction times were reduced from 15.2 (95 % CI 14.3-16.1) min to 12.5 (95 % CI 11.7-13.3) min (P < 0.001).Turnover times were shortened significantly from 38 (95 % CI 44-32) min to 11 (95 % CI 8-14) min. The incidence of re-operations, re-admissions and complications did not change.

  14. Simulation study for Mobile Ad hoc Networks Using DMAC Protocol

    Directory of Open Access Journals (Sweden)

    Vikas Sejwar

    2012-01-01

    Full Text Available This paper addresses the issue of deafness problem in Mobile Ad Hoc Networks (MANETs using directional antennas. Directional antennas arebeneficial for wireless ad hoc networks consisting of a collection of wireless hosts. A suitable Medium Access Control (MAC protocol must be designed to best utilize directional antennas. Deafness is caused whentwo nodes are in ongoing transmission and a third node (Deaf Node wants to communicate with one of that node. But it get no response because transmission of two nodes are in process. Though directional antennas offer better spatial reuse, but this problem can have a serious impact on network performance. A New DMAC (Directional Medium Access Control protocol uses flags in DNAV (Directional Network Allocation Vector tables to maintain information regarding the transmissionbetween the nodes in the network and their neighbor’s location. Two performance matrices have been used to show the impact of New DMAC algorithm on Deafness problem using simulator. These are RTS Failure Ratio and RTS Retransmission due to timeout

  15. Performance and Comparison of Multi-Hop Ad-Hoc Routing Protocols - Quantitative Study

    Directory of Open Access Journals (Sweden)

    Tamilarasan S

    2012-11-01

    Full Text Available Wireless ad-hoc network is emerging network and form temporary networks. Due to its spontaneous nature the topology is frequently changes. Protocols selection and set up routing between any pair of nodes are the primary goal design for any wireless network. Several protocols are proposed in Mobile Ad-hoc Network (MANET and selected protocol must provide best capability of data delivery and data integrity. In this paper, we are study and analysis the performance and characteristic of Ad-hoc On-demand Distance Vector (AODV, Dynamic Source Routing (DSR, Optimized Link State Routing (OLSR and Destination Sequenced Distance Vector (DSDV protocols using NS2 simulator. We are comparing the above said protocols based on the delay, throughput, control overhead and packet delivery ratio.

  16. STUDY OF QoS ISSUES FOR ROUTING PROTOCOLS in IEEE 802.11s

    Directory of Open Access Journals (Sweden)

    Nikumani Choudhury

    2013-08-01

    Full Text Available This paper focuses on the two routing protocols proposed by IEEE 802.11s for Wireless Mesh Networks. Towards this goal, this paper contributes in several areas of Routing and Quality-of-Service provisioning in IEEE 802.11-based wireless mesh networks. It compares the variety of routing protocols that could be used for Wireless Mesh Networks and later we specially focus on the recommended routing protocols HWMP and RA-OLSR by IEEE 802.11. We simulated using ns3 simulator under various parameters and observed how the two protocols reacted with changes in these parameters. From these observations, wehave been able to study and compare few QoS of the routing protocols of Wireless Mesh Networks.

  17. Study protocol: Intensive care anxiety and emotional recovery (Icare) - A prospective study

    OpenAIRE

    Castillo, M.; Aitken, L. M.; Cooke, M. L.

    2013-01-01

    Background Survivors of intensive care units (ICUs) commonly present with symptoms of anxiety, depression and post-traumatic stress disorder (PTSD) during recovery. A number of factors have been identified as predictors of these adverse emotional outcomes, but the role of state anxiety during critical illness in the development of these emotional problems remains unknown. Purpose The Intensive Care Anxiety and Emotional Recovery (ICARe) study protocol proposes the development of a s...

  18. Bulk transfer protocols on satellite link - Study within the OSI reference model

    Science.gov (United States)

    Valet, I.

    Since satellite systems, such as TELECOM1 in France, are available for data transmission, new protocols need to be designed to fit the requirements of satellite communication systems and to offer specific facilities to the users. The main features of these new transmission protocols, as they have been specified by NADIR studies, are described. Next, the reasons for choosing to study these protocols within the OSI Reference Model are explained. A detailed study about introducing the protocol mechanisms described above in the OSI Reference model layers is then presented. Different approaches are presented, and the solutions studied are appraised in terms of efficiency, and of conformity to the OSI Reference Model. Finally, the experiments planned by NADIR are mentionned.

  19. Predicting implementation from organizational readiness for change: a study protocol

    Directory of Open Access Journals (Sweden)

    Kelly P Adam

    2011-07-01

    Full Text Available Abstract Background There is widespread interest in measuring organizational readiness to implement evidence-based practices in clinical care. However, there are a number of challenges to validating organizational measures, including inferential bias arising from the halo effect and method bias - two threats to validity that, while well-documented by organizational scholars, are often ignored in health services research. We describe a protocol to comprehensively assess the psychometric properties of a previously developed survey, the Organizational Readiness to Change Assessment. Objectives Our objective is to conduct a comprehensive assessment of the psychometric properties of the Organizational Readiness to Change Assessment incorporating methods specifically to address threats from halo effect and method bias. Methods and Design We will conduct three sets of analyses using longitudinal, secondary data from four partner projects, each testing interventions to improve the implementation of an evidence-based clinical practice. Partner projects field the Organizational Readiness to Change Assessment at baseline (n = 208 respondents; 53 facilities, and prospectively assesses the degree to which the evidence-based practice is implemented. We will conduct predictive and concurrent validities using hierarchical linear modeling and multivariate regression, respectively. For predictive validity, the outcome is the change from baseline to follow-up in the use of the evidence-based practice. We will use intra-class correlations derived from hierarchical linear models to assess inter-rater reliability. Two partner projects will also field measures of job satisfaction for convergent and discriminant validity analyses, and will field Organizational Readiness to Change Assessment measures at follow-up for concurrent validity (n = 158 respondents; 33 facilities. Convergent and discriminant validities will test associations between organizational readiness and

  20. Advantages of a Warfarin Protocol for Long-term Care Pharmacists: a Retrospective Cohort Study

    OpenAIRE

    Sargent, Randall; Brocklebank, Cynthia; Tam-Tham, Helen; Williamson, Tyler; Quail, Patrick; Turner, Diana; Drummond, Neil

    2016-01-01

    Background Warfarin is an anticoagulant prescribed to 12% of long-term care residents to reduce the risk of thrombo-embolism. This study used indicators to compare warfarin management by pharmacists to usual care. Methods This was a retrospective cohort study comparing a pharmacist-managed warfarin protocol with usual care of qualified warfarin recipients at long-term care facilities (two protocol, one control) in Calgary, Alberta. We compared the proportion of international normalized ratio ...

  1. Implementation of Mass Transfusion Protocol in the Outpatient Operating Room Setting: A Case Study.

    Science.gov (United States)

    Robins, Holly-May; Warner, Brenda

    2015-06-01

    The current definition of massive transfusion is replacement of 5 U of packed red blood cells in 3 hours because of uncontrolled hemorrhage or replacement of the entire blood volume within a 24-hour period. The prompt activation of a transfusion protocol can quickly restore hemodynamic stability. Effective teamwork and communication is critical for a favorable patient outcome. This case study demonstrates the effectiveness of using a massive transfusion protocol in an outpatient setting. PMID:26137761

  2. The Oxford Participation and Activities Questionnaire: study protocol

    Directory of Open Access Journals (Sweden)

    Morley D

    2013-12-01

    Full Text Available David Morley, Sarah Dummett, Laura Kelly, Jill Dawson, Ray Fitzpatrick, Crispin JenkinsonNuffield Department of Population Health, University of Oxford, Oxford, UKBackground: With an ageing population and increasing demands on health and social care services, there is growing importance attached to the management of long-term conditions, including maximizing the cost-effectiveness of treatments. In line with this, there is increasing emphasis on the need to keep people both active and participating in daily life. Consequently, it is essential that well developed and validated instruments that can meaningfully assess levels of participation and activity are widely available. Current measures, however, are largely focused on disability and rehabilitation, and there is no measure of activity or participation for generic use that fully meets the standards set by regulatory bodies such as the US Food and Drug Administration. Here we detail a protocol for the development and validation of a new patient-reported outcome measure (PROM for assessment of participation and activity in people experiencing a variety of health conditions, ie, the Oxford Participation and Activities Questionnaire (Ox-PAQ. The stages incorporated in its development are entirely in line with current regulations and represent best practice in the development of PROMs.Methods: Development of the Ox-PAQ is theoretically grounded in the World Health Organization International Classification of Functioning, Disability, and Health. The project incorporates a new strategy of engaging with stakeholders from the outset in an attempt to identify those characteristics of PROMs considered most important to a range of potential users. Items will be generated through interviews with patients from a range of conditions. Pretesting of the instrument will be via cognitive interviews and focus groups. A postal survey will be conducted, with data subject to factor and Rasch analysis in order to

  3. Simulation Based: Study and Analysis of Routing Protocol in Vehicular Ad-hoc Network Environment

    Directory of Open Access Journals (Sweden)

    Vaishali D. Khairnar

    2012-03-01

    Full Text Available A Vehicular Ad hoc Network (VANET consists of vehicles which communicate with each other and exchange data via wireless communication links available between the vehicles which are in communication ranges of vehicles to improve the road safety in city. The communication between vehicles is used to provide road safety, comfort and entertainment. The performance of communication depends on how better routing takes place in the network. Routing data between the source and destination vehicle depends on the routing protocols being used in vehicular ad-hoc network. In this simulation based study we investigated about different ad hoc routing protocols for vehicular ad-hoc network (VANET. The main goal of our study was to identify which ad hoc routing protocol has better performance in highly mobile environment of vehicular ad-hoc network. We have measured the performance of routing protocols using 802.11p in vehicular ad-hoc network in which we considered the scenario of city (i.e. Route between Nerul and Vashi where we have take 1200 different types of vehicles and checked their performance. Routing protocols are selected after the literature review. The selected protocols are then evaluated through simulation under 802.11p in terms of performance metrics (i.e PDR & E2E delay

  4. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. METHODS AND FINDINGS: We received...... the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on Pub...... group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers stated that "all adverse events were recorded." For one trial, we identified an additional 1...

  5. A Pilot Study on the effects of Music Therapy on Frontotemporal Dementia - developing a research protocol

    DEFF Research Database (Denmark)

    Ridder, Hanne Mette Ochsner; Wigram, Tony; Ottesen, Anne Marie

    2009-01-01

    of Life (ADRQL), the Cohen-Mansfield Agitation Inventory (CMAI), and the Neuro-Psychiatric Inventory (NPI), and related to case descriptions and video analyses. Results: Recommendations for a mixed method research protocol focused on measuring the effect of music therapy with persons with frontotemporal....... As an example of a non-pharmacologic treatment procedure music therapy was investigated. With the focus to develop a research protocol for a future larger population study a pilot study was carried out. In two case studies a combination of data collection methods were examined with the overall goal to document...

  6. Older Persons’ Transitions in Care (OPTIC: a study protocol

    Directory of Open Access Journals (Sweden)

    Cummings Greta G

    2012-12-01

    Full Text Available Abstract Background Changes in health status, triggered by events such as infections, falls, and geriatric syndromes, are common among nursing home (NH residents and necessitate transitions between NHs and Emergency Departments (EDs. During transitions, residents frequently experience care that is delayed, unnecessary, not evidence-based, potentially unsafe, and fragmented. Furthermore, a high proportion of residents and their family caregivers report substantial unmet needs during transitions. This study is part of a program of research whose overall aim is to improve quality of care for frail older adults who reside in NHs. The purpose of this study is to identify successful transitions from multiple perspectives and to identify organizational and individual factors related to transition success, in order to inform improvements in care for frail elderly NH residents during transitions to and from acute care. Specific objectives are to: 1. define successful and unsuccessful elements of transitions from multiple perspectives; 2. develop and test a practical tool to assess transition success; 3. assess transition processes in a discrete set of transfers in two study sites over a one year period; 4. assess the influence of organizational factors in key practice locations, e.g., NHs, emergency medical services (EMS, and EDs, on transition success; and 5. identify opportunities for evidence-informed management and quality improvement decisions related to the management of NH – ED transitions. Methods/Design This is a mixed-methods observational study incorporating an integrated knowledge translation (IKT approach. It uses data from multiple levels (facility, care unit, individual and sources (healthcare providers, residents, health records, and administrative databases. Discussion Key to study success is operationalizing the IKT approach by using a partnership model in which the OPTIC governance structure provides for team decision-makers and

  7. Sarcopenia and its determinants among Iranian elderly (SARIR: study protocol

    Directory of Open Access Journals (Sweden)

    Hashemi Rezvan

    2012-11-01

    Full Text Available Abstract Background The elderly populations increase in world because of improved health status in communities, so health and independency of seniors has become and will be one of the main priorities of public health systems. Ageing have been associated with changes in body composition, including loss of muscle mass, loss of bone mass and increase fat mass. Involuntary age related loss of muscle mass, sarcopenia,has been linked to functional impairment and physical disability. Several definitions for sarcopenia have been presented based on the method of measuring body composition, but an internationally accepted definition doesn’t presently exist yet. In 2010, the European working group on sarcopenia developed a new definition for sarcopenia according to measure muscle mass and muscle function. Several studies have been done about sarcopenia in world, but to our knowledge this study is the first in Iran which is one of the largest countries of the Middle East that faces a fast growing elderly population. The aim of this study is to evaluate sarcopenia and related risk factors in Iran according new definition of sarcopenia. Methods This study will be conducted in two phase among elderly men and women over 55 years in the 6th district of TehranThe first phase will be a population-based cross-sectional study to determine the frequency of sarcopenia in the study population, and to conduct case finding for the second phase. The second phase will be a case–control study to comparison the metabolic and inflammatory factors in sarcopenic and non sarcopenic groups. The association between sarcopenia and major dietary pattern will be evaluated using factor analysis. Conclusion This study is the first study that evaluates sarcopenia and its risk factor in Iranian elderlies. We discuss details of how we collect the data and appropriate instruments to measure muscle mass, muscle power and muscle strength, and suitable cut- off to define sarcopenia in

  8. Virtualization of network environment and study of dynamic routing protocols

    OpenAIRE

    Tremolosa Rovira, Jaume

    2014-01-01

    [ANGLÈS] The main purpose of this thesis has been to build a Virtual Network Laboratory Environment. This concept has been performed with a virtual environment generator called VNUML developed by “Universidad Politecnica de Madrid”. All the component of this labs like VNUML, Quagga and the tools to test it like Wireshark has been studied before. In fact, we've learnt how to install Ubuntu in an USB pen-drive and all the study environment has been developed using this USB. During the thesis, w...

  9. Protocol for studying cough frequency in people with pulmonary tuberculosis

    Science.gov (United States)

    Bravard, Marjory A; Tracey, Brian H; López, José W; Comina, German; Zimic, Mirko; Coronel, Jorge; O'Neill Lee, Gwenyth; Caviedes, Luz; Luis Cabrera, Jose; Salas, Antonio; Ticona, Eduardo; Kirwan, Daniela E; Friedland, Jon S; Evans, Carlton A; Moore, David A; Gilman, Robert H

    2016-01-01

    Introduction Cough is a key symptom of tuberculosis (TB) as well as the main cause of transmission. However, a recent literature review found that cough frequency (number of coughs per hour) in patients with TB has only been studied once, in 1969. The main aim of this study is to describe cough frequency patterns before and after the start of TB treatment and to determine baseline factors that affect cough frequency in these patients. Secondarily, we will evaluate the correlation between cough frequency and TB microbiological resolution. Methods This study will select participants with culture confirmed TB from 2 tertiary hospitals in Lima, Peru. We estimated that a sample size of 107 patients was sufficient to detect clinically significant changes in cough frequency. Participants will initially be evaluated through questionnaires, radiology, microscopic observation drug susceptibility broth TB-culture, auramine smear microscopy and cough recordings. This cohort will be followed for the initial 60 days of anti-TB treatment, and throughout the study several microbiological samples as well as 24 h recordings will be collected. We will describe the variability of cough episodes and determine its association with baseline laboratory parameters of pulmonary TB. In addition, we will analyse the reduction of cough frequency in predicting TB cure, adjusted for potential confounders. Ethics and dissemination Ethical approval has been obtained from the ethics committees at each participating hospital in Lima, Peru, Asociación Benéfica PRISMA in Lima, Peru, the Universidad Peruana Cayetano Heredia in Lima, Peru and Johns Hopkins University in Baltimore, USA. We aim to publish and disseminate our findings in peer-reviewed journals. We also expect to create and maintain an online repository for TB cough sounds as well as the statistical analysis employed. PMID:27105713

  10. Protocols to study the physiology of oral biofilms.

    Science.gov (United States)

    Lemos, José A; Abranches, Jacqueline; Koo, Hyun; Marquis, Robert E; Burne, Robert A

    2010-01-01

    The oral cavity harbors several hundred different bacterial species that colonize both hard (teeth) and soft tissues, forming complex populations known as microbial biofilms. It is widely accepted that the phenotypic characteristics of bacteria grown in biofilms are substantially different from those grown in suspensions. Because biofilms are the natural habitat for the great majority of oral bacteria, including those contributing to oral diseases, a better understanding of the physiology of adherent populations is clearly needed to control oral microbes in health and disease. In this chapter, we use oral streptococci as examples for studying the physiology of oral biofilms.

  11. An Empirical Study on variants of TCP over AODV routing protocol in MANET

    CERN Document Server

    Morshed, Md Monzur; Islam, Md Rafiqul

    2011-01-01

    The cardinal concept of TCP development was to carry data within the network where network congestion plays a vital role to cause packet loss. On the other hand, there are several other reasons to lose packets in Mobile Ad Hoc Networks due to fading, interfaces, multi-path routing, malicious node, and black hole. Along with throughput, fairness of TCP protocols is important to establish a good communication. In this paper, an empirical study has been done by simulation and analysis of TCP variations under AODV routing protocol. In our simulation, we studied multiple variations of TCP, such as Reno, New-Reno, Vegas, and Tahoe. The simulation work has been done in NS2 environment. Based on the analysis simulation result of we carried out our observations with respect to the behavior of AODV routing protocol for different TCP packets under several QoS metrics such as drop, throughput, delay, and jitter.

  12. Study protocol for the Fukushima health management survey

    International Nuclear Information System (INIS)

    The accidents that occurred at the Fukushima Daiichi Nuclear Power Plant after the Great East Japan Earthquake on 11 March 2011 have resulted in long-term, ongoing anxiety among the residents of Fukushima, Japan. Soon after the disaster, Fukushima Prefecture launched the Fukushima Health Management Survey to investigate long-term low-dose radiation exposure caused by the accident. Fukushima Medical University took the lead in planning and implementing this survey. The primary purposes of this survey are to monitor the long-term health of residents, promote their future well-being, and confirm whether long-term low-dose radiation exposure has health effects. This report describes the rationale and implementation of the Fukushima Health Management Survey. This cohort study enrolled all people living in Fukushima Prefecture after the earthquake and comprises a basic survey and 4 detailed surveys. The basic survey is to estimate levels of external radiation exposure among all 2.05 million residents. It should be noted that internal radiation levels were estimated by Fukushima Prefecture using whole-body counters. The detailed surveys comprise a thyroid ultrasound examination for all Fukushima children aged 18 years or younger, a comprehensive health check for all residents from the evacuation zones, an assessment of mental health and lifestyles of all residents from the evacuation zones, and recording of all pregnancies and births among all women in the prefecture who were pregnant on 11 March. All data have been entered into a database and will be used to support the residents and analyze the health effects of radiation. The low response rate (<30%) to the basic survey complicates the estimation of health effects. There have been no cases of malignancy to date among 38 114 children who received thyroid ultrasound examinations. The importance of mental health care was revealed by the mental health and lifestyle survey and the pregnancy and birth survey. This long

  13. FIRE (facilitating implementation of research evidence: a study protocol

    Directory of Open Access Journals (Sweden)

    Seers Kate

    2012-03-01

    Full Text Available Abstract Background Research evidence underpins best practice, but is not always used in healthcare. The Promoting Action on Research Implementation in Health Services (PARIHS framework suggests that the nature of evidence, the context in which it is used, and whether those trying to use evidence are helped (or facilitated affect the use of evidence. Urinary incontinence has a major effect on quality of life of older people, has a high prevalence, and is a key priority within European health and social care policy. Improving continence care has the potential to improve the quality of life for older people and reduce the costs associated with providing incontinence aids. Objectives This study aims to advance understanding about the contribution facilitation can make to implementing research findings into practice via: extending current knowledge of facilitation as a process for translating research evidence into practice; evaluating the feasibility, effectiveness, and cost-effectiveness of two different models of facilitation in promoting the uptake of research evidence on continence management; assessing the impact of contextual factors on the processes and outcomes of implementation; and implementing a pro-active knowledge transfer and dissemination strategy to diffuse study findings to a wide policy and practice community. Setting and sample Four European countries, each with six long-term nursing care sites (total 24 sites for people aged 60 years and over with documented urinary incontinence Methods and design Pragmatic randomised controlled trial with three arms (standard dissemination and two different programmes of facilitation, with embedded process and economic evaluation. The primary outcome is compliance with the continence recommendations. Secondary outcomes include proportion of residents with incontinence, incidence of incontinence-related dermatitis, urinary tract infections, and quality of life. Outcomes are assessed at baseline

  14. The Bipolar Interactive Psychoeducation (BIPED study: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Jones Ian

    2009-08-01

    Full Text Available Abstract Background Bipolar disorders affect between 3–5% of the population and are associated with considerable lifelong impairment. Since much of the morbidity associated with bipolar disorder is caused by recurrent depressive symptoms, which are often only poorly responsive to antidepressants, there is a need to develop alternative, non-pharmacological interventions. Psychoeducational interventions have emerged as promising long-term therapeutic options for bipolar disorder. Methods/design The study is an exploratory, individually randomised controlled trial. The intervention known as 'Beating Bipolar' is a psychoeducational programme which is delivered via a novel web-based system. We will recruit 100 patients with a diagnosis of DSM-IV bipolar disorder (including type I and type II currently in clinical remission. The primary outcome is quality of life. This will be compared for those patients who have participated in the psychoeducational programme with those who received treatment as usual. Quality of life will be assessed immediately following the intervention as well as 10 months after randomisation. Secondary outcomes include current depressive and manic symptoms, number of episodes of depression and mania/hypomania experienced during the follow-up period, global functioning, functional impairment and insight. An assessment of costs and a process evaluation will also be conducted which will explore the feasibility and acceptability of the intervention as well as potential barriers to effectiveness. Discussion Bipolar disorder is common, under-recognised and often poorly managed. It is a chronic, life-long, relapsing condition which has an enormous impact on the individual and the economy. This trial will be the first to explore the effectiveness of a novel web-based psychoeducational intervention for patients with bipolar disorder which has potential to be easily rolled out to patients. Trial registration Current Controlled Trials

  15. Comparative study of preventive protocols in children at high cariogenic risk.

    Science.gov (United States)

    Martínez, María C; Tolcachir, Betina; Lescano de Ferrer, Alfonsina; Bojanich, María A; Barembaum, Silvina R; Calamari, Silvia E; Azcurra, Ana I

    2012-01-01

    The aim of this study was to compare the efficacy of two preventive protocols -fluoride gel (F) alone or combined with chlorhexidine varnishes (CHX) - on sialochemical, clinical and microbiological parameters in a group of children at high cariogenic risk Two therapeutic-preventive protocols were applied in 73 children at high cariogenic risk (average age 6.2 +/- 1.4 years old) and clinical parameters (simplified oral hygiene index: OHI-S; decayed, missing and filled teeth: dmf index; sugar intake and exposure to fluoride), as well as sialochemical parameters (salivary pH and flow, buffer capacity) and microbiological parameters (CFU/mg of dental biofilm of Streptococcus mutans group) were recorded and correlated before and after the protocols. Association was found between parameters that cause deficient control of dental biofilm: high values of OHIS index, CFU/mg dental biofilm, sugar intake and the d component of dmft index, and lower values of salivary flow rate and buffer capacity. After the protocols, a significant decrease was found in OHI-S and CFU/mg dental biofilm. No significant difference was found with children's gender and age. The association observed between OHI-S and cariogenic bacteria emphasizes the importance of prevention, especially regarding the oral health of the most vulnerable children. The early inclusion of F associated with CHX in the initial step of preventive and therapeutic protocols would provide benefits regarding oral microbe control while children acquire new habits of oral hygiene.

  16. Advantages of a Warfarin Protocol for Long-term Care Pharmacists: a Retrospective Cohort Study

    Science.gov (United States)

    Sargent, Randall; Brocklebank, Cynthia; Tam-Tham, Helen; Williamson, Tyler; Quail, Patrick; Turner, Diana; Drummond, Neil

    2016-01-01

    Background Warfarin is an anticoagulant prescribed to 12% of long-term care residents to reduce the risk of thrombo-embolism. This study used indicators to compare warfarin management by pharmacists to usual care. Methods This was a retrospective cohort study comparing a pharmacist-managed warfarin protocol with usual care of qualified warfarin recipients at long-term care facilities (two protocol, one control) in Calgary, Alberta. We compared the proportion of international normalized ratio (INR) tests in the range 2.0 to 3.0, time in range, number of tests, and frequency of bleeding at protocol and control sites. Our primary outcome, time in INR therapeutic range, is an indicator for assuring care quality. A cross-sectional survey at these sites compared health professionals’ perceptions of workload and effectiveness of warfarin management. Results Of the 197 residents’ charts reviewed in the study period, those on protocol had 45.0 INR tests while those on usual care had 52.7 tests (p = .034, 95% CI for the difference: 0.6 to 14.6 INR tests). No significant difference was found for time in therapeutic range, number of tests in range, or major bleeding events. Of 178 health professionals surveyed, those from protocol facilities were more satisfied with warfarin management (p = .013). Workload and safety were perceived similarly at all sites. Interpretation Our results suggest that a pharmacist-managed warfarin protocol is as effective as usual care and has advantages pertaining to work satisfaction, knowledge of drug interactions, consistent documentation, and fewer INR tests. Further research on teamwork and coagulation management in long-term care facilities is recommended. PMID:27403212

  17. STUDY & ANALYSIS OF SECURED E-COMMERCE TRANSACTIONS INFORMATION PROTOCOLS-PURCHASING ORDER

    Directory of Open Access Journals (Sweden)

    Deepu Soni

    2012-09-01

    Full Text Available Electronic Commerce is the very rapid growing field in today’s scenario. It is used for Purchasing Order i.e. for buying and selling electronic goods and all other type of things. And there is need for development of a number of e-commerce protocols, which ensure integrity, confidentiality, atomicity and fair exchange.The protocol uses a smart card for ensuring mutual authentication, dispute resolution and fair exchange and reduces reliance on a trusted third party. Also study and analysis of the security in e-transactions may avoid some of the frauds on internet transactionsfor purchasing and buying orders.

  18. Declarative Specification of Fault Tolerant Auction Protocols: The English Auction Case Study

    DEFF Research Database (Denmark)

    Dragoni, Nicola; Gaspari, Mauro

    2012-01-01

    and shared allowing agents to dynamically engage well‐known and trusted negotiation protocols. To cope with real‐world applications, these rules should also specify fault tolerant patterns of interaction, enabling negotiating agents to interact with each other tolerating failures, for instance terminating...... an auction process even if some bidding agents dynamically crash. In this paper, we propose an approach to specify fault tolerant auction protocols in open and dynamic environments by means of communication rules dealing with crash failures of agents. We illustrate these concepts considering a case study...

  19. STUDY ON NEIGHBORHOOD DISCOVERY PROTOCOL IN COMMUNICATION NETWORKSGRANULAR SLUDGE BY BATCH TESTS

    Institute of Scientific and Technical Information of China (English)

    时成阁; 胡家骏

    2001-01-01

    One algorithm and one method for PNNI(Private Network to Network Interface) routing were presented. The algorithm is OIL (Older Is Leader) algorithms for Peer Group selection, and the method is the DOO (Distributed object-oriented) method for HDOS (Hierarchy Distributed-Object System), PNNI systems and IP(Internet Protocol) networks. Based on the specifications from ATM forum, and the creative ideas from Distributed System realization, this paper studies and analyzes the private ATM network environment. The OIL algorithm and the DOO method are both for PNNI routing protocol. Through the PNNI simulation, the availability and robustness are proved for the above two improvements.

  20. Digital protocol for reference-based guided surgery and immediate loading: a prospective clinical study

    NARCIS (Netherlands)

    A. Tahmaseb; R. de Clerck; I. Aartman; D. Wismeijer

    2012-01-01

    PURPOSE: To evaluate the performance of a computer-aided three-dimensional planning protocol in combination with previously inserted reference mini-implants and CAD/CAM technology to restore completely edentulous patients. The study evaluated implant and superstructure survival in a prospective clin

  1. The Dutch 'Focus on Strength' intervention study protocol : programme design and production, implementation and evaluation plan

    NARCIS (Netherlands)

    Ten Hoor, G A; Kok, G; Rutten, G M; Ruiter, R A C; Kremers, S P J; Schols, A M J W; Plasqui, G

    2016-01-01

    BACKGROUND: Overweight youngsters are better in absolute strength exercises than their normal-weight counterparts; a physiological phenomenon with promising psychological impact. In this paper we describe the study protocol of the Dutch, school-based program 'Focus on Strength' that aims to improve

  2. COMPARATIVE STUDY ON ENERGY CONSUMPTION IN DYNAMIC WINDOW SECURED IMPLICIT GEOGRAPHIC FORWARDING ROUTING PROTOCOL

    Directory of Open Access Journals (Sweden)

    Abubakar Idris Umar

    2014-01-01

    Full Text Available An Ideal WSNs should operate with the least possible energy required in order to increase the lifetime of the sensor nodes and at the same time, ensure network connectivity. But the Inherent power limitation makes power-awareness a critical requirement for WSN, this calls for the need to manage energy in sensor nodes. Also In order to ensure successful transmission of data from sensor node source to destination, it becomes necessary to maintain network availability. The network must be resilient to individual node failure which can happen due to zero power posses by the node and due to security attacks posed on the node and the network. Dynamic Window Secured Implicit Geographic Forwarding (DWSIGF routing protocol has proven to be robust, efficient and resistant to some security attack which causes failure in network availability. However the extent to which energy is consumed in sensor nodes which deploys DWSIGF as its routing protocol has never been mentioned. In this research, we performed a comparative study on energy consumption in DWSIGF routing protocol. Using the first order radio model, we determined the energy consumed in a network. The protocol (DWSIGF is matched up against its counterpart SIGF as the traffic is increased. Observation shows that DWSIGF due to the variable timing assigned to the CTS collection window, CTS signal fails to reach destination as collection window time expires, thus the need for retransmission. This in turn consumes more energy than the counterpart SIGF which has a fixed CTS collection time. The simulation work was done using Matlab 7.0. Energy consumed in the random variant of both protocols (DWSIGF and SIGF was also observed to be higher than the priority variant of the protocols.

  3. A Pilot Study Involving the Effect of Two Different Complex Training Protocols on Lower Body Power

    OpenAIRE

    Smith Chad E.; Lyons Brian; Hannon James C.

    2014-01-01

    Purpose. Complex training (CT) involves the coupling of two exercises ostensibly to enhance the effect of the second exercise. Typically, the first exercise is a strength exercise and the second exercise is a power exercise involving similar muscles. In most cases, CT is designed to enhance power. The purpose of this study was twofold. First, this study was designed to determine if lower body power could be enhanced using complex training protocols. Second, this study investigated whether the...

  4. Efficacy of family mediation and the role of family violence: study protocol

    OpenAIRE

    Cleak, Helen; Schofield, Margot; Bickerdike, Andrew

    2014-01-01

    Background Family law reforms in Australia require separated parents in dispute to attempt mandatory family dispute resolution (FDR) in community-based family services before court attendance. However, there are concerns about such services when clients present with a history of high conflict and family violence. This study protocol describes a longitudinal study of couples presenting for family mediation services. The study aims to describe the profile of family mediation clients, including ...

  5. Bridging the gap between comprehensive extraction protocols in plant metabolomics studies and method validation.

    Science.gov (United States)

    Bijttebier, Sebastiaan; Van der Auwera, Anastasia; Foubert, Kenn; Voorspoels, Stefan; Pieters, Luc; Apers, Sandra

    2016-09-01

    It is vital to pay much attention to the design of extraction methods developed for plant metabolomics, as any non-extracted or converted metabolites will greatly affect the overall quality of the metabolomics study. Method validation is however often omitted in plant metabolome studies, as the well-established methodologies for classical targeted analyses such as recovery optimization cannot be strictly applied. The aim of the present study is to thoroughly evaluate state-of-the-art comprehensive extraction protocols for plant metabolomics with liquid chromatography-photodiode array-accurate mass mass spectrometry (LC-PDA-amMS) by bridging the gap with method validation. Validation of an extraction protocol in untargeted plant metabolomics should ideally be accomplished by validating the protocol for all possible outcomes, i.e. for all secondary metabolites potentially present in the plant. In an effort to approach this ideal validation scenario, two plant matrices were selected based on their wide versatility of phytochemicals: meadowsweet (Filipendula ulmaria) for its polyphenols content, and spicy paprika powder (from the genus Capsicum) for its apolar phytochemicals content (carotenoids, phytosterols, capsaicinoids). These matrices were extracted with comprehensive extraction protocols adapted from literature and analysed with a generic LC-PDA-amMS characterization platform that was previously validated for broad range phytochemical analysis. The performance of the comprehensive sample preparation protocols was assessed based on extraction efficiency, repeatability and intermediate precision and on ionization suppression/enhancement evaluation. The manuscript elaborates on the finding that none of the extraction methods allowed to exhaustively extract the metabolites. Furthermore, it is shown that depending on the extraction conditions enzymatic degradation mechanisms can occur. Investigation of the fractions obtained with the different extraction methods

  6. Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

    Science.gov (United States)

    Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T

    2016-01-01

    Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer

  7. Stream Control Transmission Protocol as a Transport for SIP: a case study

    Directory of Open Access Journals (Sweden)

    Giuseppe De Marco

    2004-06-01

    Full Text Available The dominant signalling protocol both in future wireless and wired networks will be the Session Initiation Protocol (SIP, as pointed out in the 3G IP-based mobile networks specifications, entailing a fully Internet integrated network. The use of SIP in the IP Multimedia Subsytem (IMS of Release 5 involves the development of servers capable to handle a large number of call requests. The signaling traffic associated to such requests could explode, if an intelligent congestion control were not introduced. Stream Control Transmission Protocol (SCTP was born to support transport of SS7 signaling messages. However, many of the SCTP features are also useful for transport of SIP messages, as: congestion control mechanism, good separation among independent messages, multihoming. Indeed, adoption of SCTP as transport of SIP signaling might prove useful in some situations where usual transport protocols, like TCP and UDP, suffer performance degradation. In this paper, we analyse the general framework wherein SIP operates and we discuss the benefits of using SCTP as a transport for SIP, toward fair sharing of network resources. This study is carried on in the context of the implementation of an high-performance SIP Proxy Server. We also present some preliminar results of an implementation of SIP over SCTP/UDP in a real LAN environment.

  8. Disinfection Contact Time study plan (100-N Area tracer protocol). Revision 1

    International Nuclear Information System (INIS)

    Bechtel Hanford, Inc. will prepare an Engineering Tracer Study Protocol for the determination of contact time for the disinfection process at Group A Non-transient Non-community water treatment plant for the 100-N Water Plant at the Hanford Site in Richland, Washington. Included in this report are the results of a study that determine the actual detention time within the plant clearwell, and thus the disinfection contact time at several clearwell effluent flow rates

  9. A prospective study of GnRH long agonist versus flexible GnRH antagonist protocol in PCOS: Indian experience

    Directory of Open Access Journals (Sweden)

    Harpreet Kaur

    2012-01-01

    Full Text Available Background: Polycystic ovarian syndrome is a common endocrine disorder of reproductive age women. Many controlled ovarian stimulation (COS strategies have been offered for the treatment of patients with PCOS undergoing in vitro fertilization, but the optimal protocol is still a controversy. There is no compelling evidence for the advantage of one stimulation protocol over the other. Materials and Methods: This is a single-center prospective controlled study comparing long agonist and antagonist protocol in PCOS women. Results: There was no significant difference in live birth rate and clinical pregnancy rate. Rate of ovarian hyperstimulation syndrome was significantly higher in the agonist group. Number of oocytes retrieved, number of follicles and peak estradiol levels were significantly more in the agonist group. Conclusion: The GnRH antagonist protocol is an equally effective but safer protocol in PCOS patients compared with the long agonist protocol.

  10. Proposed computerized protocol for epidemiological study of patients undergoing microsurgery of the larynx

    OpenAIRE

    Catani, Guilherme Simas do Amaral; Carvalho, Bettina; Ido Filho, Jorge Massaaki; Macedo Filho, Evaldo Dacheux de; Pinto, José Simão de Paula; Malafaia, Osvaldo; Stahlke Junior, Henrique Jorge, 1942-

    2012-01-01

    Summary Introduction: The merging of medicine with information technology facilitates the retrieval of stored data, aiding the conduct of research with greater scientific rigor. Studies in the field of otorhinolaryngology, specifically in the area of laryngology and voice, are of fundamental importance, since 70% of the economically active need their voice to work. Objective: To create a computerized protocol of the diseases of the larynx, apply and validate it, and use it to evaluate patient...

  11. Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial

    OpenAIRE

    Hayes Loran P; Tsao Jennie CI; Allen Laura B; Zeltzer Lonnie K

    2011-01-01

    Abstract Background This protocol is for a study of a new program to improve outcomes in children suffering from chronic pain disorders, such as fibromyalgia, recurrent headache, or recurrent abdominal pain. Although teaching active pain self-management skills through cognitive-behavioral therapy (CBT) or a complementary program such as hypnotherapy or yoga has been shown to improve pain and functioning, children with low expectations of skill-building programs may lack motivation to comply w...

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

    OpenAIRE

    Fayers Peter; Namisango Eve; Mwangi-Powell Faith; Powell Richard A; Downing Julia; Moreland Scott; McCrone Paul; Penfold Suzanne; Simms Victoria; Harding Richard; Curtis Siân; Higginson Irene J

    2010-01-01

    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 uti...

  13. A follow-up study of heroin addicts (VEdeTTE2: study design and protocol

    Directory of Open Access Journals (Sweden)

    Lampis Fabio

    2007-03-01

    Full Text Available Abstract Background In Italy, a large cohort study (VEdeTTE1 was conducted between 1998–2001 to evaluate the effectiveness of treatments in reducing mortality and increasing treatment retention among heroin addicts. The follow-up of this cohort (VEdeTTE2 was designed to evaluate the effectiveness of treatments on long-term outcomes, such as rehabilitation and social re-integration. The purpose of this paper is to describe the protocol of the VEdeTTE2 study, and to present the results of the pilot study carried out to assess the feasibility of the study and to improve study procedures. Methods The source population for the VEdeTTE2 study was the VEdeTTE1 cohort, from which a sample of 2,200 patients, traced two or more years after enrolment in the cohort, were asked to participate. An interview investigates drug use; overdose; family and social re-integration. Illegal activity are investigated separately in a questionnaire completed by the patient. Patients are also asked to provide a hair sample to test for heroin and cocaine use. Information on treatments and HIV, HBV and HCV morbidity are obtained from clinical records. A pilot phase was planned and carried out on 60 patients. Results The results of the pilot phase pointed out the validity of the procedures designed to limit attrition: the number of traced subjects was satisfactory (88%. Moreover, the pilot phase was very useful in identifying possible causes of delays and attrition, and flaws in the instruments. Improvements to the procedures and the instruments were subsequently implemented. Sensitivity of the biological test was quite good for heroin (78% but lower for cocaine (42.3%, highlighting the need to obtain a hair sample from all patients. Conclusion In drug addiction research, studies investigating health status and social re-integration of subjects at long-term follow-up are lacking. The VEdeTTE2 study aims to investigate these outcomes at long-term follow-up. Results of the

  14. Factors influencing ambulance nurses' adherence to a national protocol ambulance care: an implementation study in the Netherlands

    NARCIS (Netherlands)

    Ebben, R.H.; Vloet, L.C.M.; Grunsven, P.M. van; Breeman, W.; Goosselink, B.; Lichtveld, R.A.; Groot, J. de; Achterberg, T. van

    2015-01-01

    OBJECTIVES: Adherence to prehospital guidelines and protocols is suboptimal. Insight into influencing factors is necessary to improve adherence. The aim of this study was to identify factors that influence ambulance nurses' adherence to a National Protocol Ambulance Care (NPAC). METHODS: A questionn

  15. The longitudinal urban cohort ageing study (LUCAS: study protocol and participation in the first decade

    Directory of Open Access Journals (Sweden)

    Dapp Ulrike

    2012-07-01

    Full Text Available Abstract Background We present concept, study protocol and selected baseline data of the Longitudinal Urban Cohort Ageing Study (LUCAS in Germany. LUCAS is a long-running cohort study of community-dwelling seniors complemented by specific studies of geriatric patients or diseases. Aims were to (1 Describe individual ageing trajectories in a metropolitan setting, documenting changes in functional status, the onset of frailty, disability and need of care; (2 Find determinants of healthy ageing; (3 Assess long-term effects of specific health promotion interventions; (4 Produce results for health care planning for fit, pre-frail, frail and disabled elderly persons; (5 Set up a framework for embedded studies to investigate various hypotheses in specific subgroups of elderly. Methods/Design In 2000, twenty-one general practitioners (GPs were recruited in the Hamburg metropolitan area; they generated lists of all their patients 60 years and older. Persons not terminally ill, without daily need of assistance or professional care were eligible. Of these, n = 3,326 (48 % agreed to participate and completed a small (baseline and an extensive health questionnaire (wave 1. In 2007/2008, a re-recruitment took place including 2,012 participants: 743 men, 1,269 women (647 deaths, 197 losses, 470 declined further participation. In 2009/2010 n = 1,627 returned the questionnaire (90 deaths, 47 losses, 248 declined further participation resulting in a good participation rate over ten years with limited and quantified dropouts. Presently, follow-up data from 2007/2008 (wave 2 and 2009/2010 (wave 3 are available. Data wave 4 is due in 2011/2012, and the project will be continued until 2013. Information on survival and need of nursing care was collected continuously and cross-checked against official records. We used Fisher’s exact test and t-tests. The study served repeatedly to evaluate health promotion interventions and concepts. Discussion LUCAS

  16. On shaky ground - A study of security vulnerabilities in control protocols

    International Nuclear Information System (INIS)

    The recent introduction of information technologies such as Ethernet R into nuclear industry control devices has resulted in significantly less isolation from the outside world. This raises the question of whether these systems could be attacked by malware, network hackers or professional criminals to cause disruption to critical operations in a manner similar to the impacts now felt in the business world. To help answer this question, a study was undertaken to test a representative control protocol to determine if it had vulnerabilities that could be exploited. A framework was created in which a test could express a large number of test cases in very compact formal language. This in turn, allowed for the economical automation of both the generation of selectively malformed protocol traffic and the measurement of device under test's (DUT) behavior in response to this traffic. Approximately 5000 protocol conformance tests were run against two major brands of industrial controller. More than 60 categories of errors were discovered, the majority of which were in the form of incorrect error responses to malformed traffic. Several malformed packets however, caused the device to respond or communicate in inappropriate ways. These would be relatively simple for an attacker to inject into a system and could result in the plant operator losing complete view or control of the control device. Based on this relatively small set of devices, we believe that the nuclear industry urgently needs to adopt better security robustness testing of control devices as standard practice. (authors)

  17. Proposed computerized protocol for epidemiological study of patients undergoing microsurgery of the larynx

    Directory of Open Access Journals (Sweden)

    Catani, Guilherme Simas do Amaral

    2012-01-01

    Full Text Available Introduction: The merging of medicine with information technology facilitates the retrieval of stored data, aiding the conduct of research with greater scientific rigor. Studies in the field of otorhinolaryngology, specifically in the area of laryngology and voice, are of fundamental importance, since 70% of the economically active need their voice to work. Objective: To create a computerized protocol of the diseases of the larynx, apply and validate it, and use it to evaluate patients undergoing laryngoscopic microsurgery of the larynx. Method: We created a database of ENT diseases through a literature review of textbooks and scientific articles. Next, we computerized the data and incorporated it into the SINPE©, creating a master protocol (ENT diseases and a specific protocol (laryngeal diseases. Data were collected prospectively from patients undergoing laryngeal microsurgery in the ENT Hospital of Paraná. The collected data were analyzed with graphs through the SINPE© Analyzer module. Results: We evaluated 245 patients aged 9-79 years, and determined that 36.61% (93 patients underwent surgery for the presence of polyps on the vocal folds, 12.6% (32 underwent surgery for papillomatosis, and 11.83% (29 underwent surgery for intracordal cysts. Conclusions: The creation of an electronic database of clinical ENT diseases was feasible. We were also able to implement and validate the protocol. The database may be released to physicians involved in clinical data collection and retrieval of information to conduct scientific research in an organized manner. The most common laryngeal disorders identified were polyps, papilloma, and intracordal cysts.

  18. Efficiency of different protocols for enamel clean-up after bracket debonding: an in vitro study

    Science.gov (United States)

    Sigilião, Lara Carvalho Freitas; Marquezan, Mariana; Elias, Carlos Nelson; Ruellas, Antônio Carlos; Sant'Anna, Eduardo Franzotti

    2015-01-01

    Objective: This study aimed to assess the efficiency of six protocols for cleaning-up tooth enamel after bracket debonding. Methods: A total of 60 premolars were divided into six groups, according to the tools used for clean-up: 12-blade bur at low speed (G12L), 12-blade bur at high speed (G12H), 30-blade bur at low speed (G30L), DU10CO ORTHO polisher (GDU), Renew System (GR) and Diagloss polisher (GD). Mean roughness (Ra) and mean roughness depth (Rz) of enamel surface were analyzed with a profilometer. Paired t-test was used to assess Ra and Rz before and after enamel clean-up. ANOVA/Tukey tests were used for intergroup comparison. The duration of removal procedures was recorded. The association between time and variation in enamel roughness (∆Ra, ∆Rz) were evaluated by Pearson's correlation test. Enamel topography was assessed by scanning electron microscopy (SEM). Results: In Groups G12L and G12H, original enamel roughness did not change significantly. In Groups G30L, GDU, GR and GD, a smoother surface (p < 0.05) was found after clean-up. In Groups G30L and GD, the protocols used were more time-consuming than those used in the other groups. Negative and moderate correlation was observed between time and (∆Ra, ∆Rz); Ra and (∆Ra, ∆Rz); Rz (r = - 0.445, r = - 0.475, p < 0.01). Conclusion: All enamel clean-up protocols were efficient because they did not result in increased surface roughness. The longer the time spent performing the protocol, the lower the surface roughness. PMID:26560825

  19. Efficiency of different protocols for enamel clean-up after bracket debonding: an in vitro study

    Directory of Open Access Journals (Sweden)

    Lara Carvalho Freitas Sigilião

    2015-10-01

    Full Text Available Objective: This study aimed to assess the efficiency of six protocols for cleaning-up tooth enamel after bracket debonding.Methods:A total of 60 premolars were divided into six groups, according to the tools used for clean-up: 12-blade bur at low speed (G12L, 12-blade bur at high speed (G12H, 30-blade bur at low speed (G30L, DU10CO ORTHO polisher (GDU, Renew System (GR and Diagloss polisher (GD. Mean roughness (Ra and mean roughness depth (Rz of enamel surface were analyzed with a profilometer. Paired t-test was used to assess Ra and Rz before and after enamel clean-up. ANOVA/Tukey tests were used for intergroup comparison. The duration of removal procedures was recorded. The association between time and variation in enamel roughness (∆Ra, ∆Rz were evaluated by Pearson's correlation test. Enamel topography was assessed by scanning electron microscopy (SEM.Results:In Groups G12L and G12H, original enamel roughness did not change significantly. In Groups G30L, GDU, GR and GD, a smoother surface (p < 0.05 was found after clean-up. In Groups G30L and GD, the protocols used were more time-consuming than those used in the other groups. Negative and moderate correlation was observed between time and (∆Ra, ∆Rz; Ra and (∆Ra, ∆Rz; Rz (r = - 0.445, r = - 0.475, p < 0.01.Conclusion:All enamel clean-up protocols were efficient because they did not result in increased surface roughness. The longer the time spent performing the protocol, the lower the surface roughness.

  20. Why standard brain-computer interface (BCI) training protocols should be changed: an experimental study

    Science.gov (United States)

    Jeunet, Camille; Jahanpour, Emilie; Lotte, Fabien

    2016-06-01

    Objective. While promising, electroencephaloraphy based brain–computer interfaces (BCIs) are barely used due to their lack of reliability: 15% to 30% of users are unable to control a BCI. Standard training protocols may be partly responsible as they do not satisfy recommendations from psychology. Our main objective was to determine in practice to what extent standard training protocols impact users’ motor imagery based BCI (MI-BCI) control performance. Approach. We performed two experiments. The first consisted in evaluating the efficiency of a standard BCI training protocol for the acquisition of non-BCI related skills in a BCI-free context, which enabled us to rule out the possible impact of BCIs on the training outcome. Thus, participants (N = 54) were asked to perform simple motor tasks. The second experiment was aimed at measuring the correlations between motor tasks and MI-BCI performance. The ten best and ten worst performers of the first study were recruited for an MI-BCI experiment during which they had to learn to perform two MI tasks. We also assessed users’ spatial ability and pre-training μ rhythm amplitude, as both have been related to MI-BCI performance in the literature. Main results. Around 17% of the participants were unable to learn to perform the motor tasks, which is close to the BCI illiteracy rate. This suggests that standard training protocols are suboptimal for skill teaching. No correlation was found between motor tasks and MI-BCI performance. However, spatial ability played an important role in MI-BCI performance. In addition, once the spatial ability covariable had been controlled for, using an ANCOVA, it appeared that participants who faced difficulty during the first experiment improved during the second while the others did not. Significance. These studies suggest that (1) standard MI-BCI training protocols are suboptimal for skill teaching, (2) spatial ability is confirmed as impacting on MI-BCI performance, and (3) when faced

  1. Why standard brain-computer interface (BCI) training protocols should be changed: an experimental study

    Science.gov (United States)

    Jeunet, Camille; Jahanpour, Emilie; Lotte, Fabien

    2016-06-01

    Objective. While promising, electroencephaloraphy based brain-computer interfaces (BCIs) are barely used due to their lack of reliability: 15% to 30% of users are unable to control a BCI. Standard training protocols may be partly responsible as they do not satisfy recommendations from psychology. Our main objective was to determine in practice to what extent standard training protocols impact users’ motor imagery based BCI (MI-BCI) control performance. Approach. We performed two experiments. The first consisted in evaluating the efficiency of a standard BCI training protocol for the acquisition of non-BCI related skills in a BCI-free context, which enabled us to rule out the possible impact of BCIs on the training outcome. Thus, participants (N = 54) were asked to perform simple motor tasks. The second experiment was aimed at measuring the correlations between motor tasks and MI-BCI performance. The ten best and ten worst performers of the first study were recruited for an MI-BCI experiment during which they had to learn to perform two MI tasks. We also assessed users’ spatial ability and pre-training μ rhythm amplitude, as both have been related to MI-BCI performance in the literature. Main results. Around 17% of the participants were unable to learn to perform the motor tasks, which is close to the BCI illiteracy rate. This suggests that standard training protocols are suboptimal for skill teaching. No correlation was found between motor tasks and MI-BCI performance. However, spatial ability played an important role in MI-BCI performance. In addition, once the spatial ability covariable had been controlled for, using an ANCOVA, it appeared that participants who faced difficulty during the first experiment improved during the second while the others did not. Significance. These studies suggest that (1) standard MI-BCI training protocols are suboptimal for skill teaching, (2) spatial ability is confirmed as impacting on MI-BCI performance, and (3) when faced

  2. Predicción numérica del afino de los granos en la zona afectada por la temperatura (ZAC para aportes de multipasadas durante el proceso de soldeo SMAW en el acero al Cr-Mo-V

    Directory of Open Access Journals (Sweden)

    Mazur, Z.

    2002-02-01

    Full Text Available The methodology of prediction of the heat-affected zone (HAZ microstructure in a multiple-bead welds of the two layers of 1.25Cr-1Mo-0.25V steel using SMAW deposition process is presented. A computer program was developed to calculate extension zones of interest of two layer multipass weld-beads HAZ and predict a percentage of HAZ coarse grains refinement for determined welding parameters, preheating temperature and weldbead overlap. The computer model has been validated by experiment depositing a series of two-layer weld-beads getting reasonable concordance of model prediction and measured during experiment structural HAZ distribution. Keywords HAZ microstructure. Numerical simulation. Cr-Mo-V steel. Two-layer multipass weld-beads

    Se presenta una metodología de predicción de las dimensiones de la zonas que ocupan distintos tamaños de grano de la zona afectada por la temperatura (ZAC, en los aportes de multipasadas de dos capas, aplicada al acero de baja aleación 1,25Cr-1Mo-0,25V por el soldeo SMAW. Se desarrolló un programa por ordenador para calcular la extensión de las regiones de distintos tamaños de grano en la ZAC de multipasadas de dos capas y predecir el porcentaje de afino de los granos gruesos de la ZAC para determinados parámetros de soldeo, temperatura de precalentamiento y solapamiento de los cordones. Se llevó a cabo la validación del modelo realizando una comparación con los resultados experimentales aportando varios cordones de soldadura en dos capas, obteniendo una razonable concordancia entre la predicción del modelo y la distribución estructural de la ZAC medida durante el experimento. Palabras clave Microestructura de la ZAC. Simulación numérica. Aceros al Cr-Mo-V. Soldadura SMAW. Cordones múltiples de soldadura de dos capas.

  3. Enhancing research quality and reporting: why the Journal of Comorbidity is now publishing study protocols

    Directory of Open Access Journals (Sweden)

    Susan Smith

    2014-08-01

    Full Text Available The Journal of Comorbidity was launched in 2011 and has since become established as a high-quality journal that publishes open-access, peer-reviewed articles, with a focus on advancing the clinical management of patients with comorbidity/multimorbidity. To further enhance research quality and reporting of studies in this field, the journal is now offering authors the opportunity to publish a summary of their study protocols – a move designed to generate interest and raise awareness in ongoing clinical research and to enable researchers to detail their methodologies in order that replication by scientific peers is possible.

  4. Research on Protocol Migration

    Institute of Scientific and Technical Information of China (English)

    汪芸; 顾冠群; 等

    1996-01-01

    This paper elaborates the concept and model of protocol migration in network interconnection.Migration strategies and principles are discussed and several cases are studied in detail which show the basic procedure and techniques used in protocol migration.

  5. The Newcastle 85+ study: biological, clinical and psychosocial factors associated with healthy ageing: study protocol

    Directory of Open Access Journals (Sweden)

    Martin-Ruiz Carmen

    2007-06-01

    Full Text Available Abstract Background The UK, like other developed countries, is experiencing a marked change in the age structure of its population characterised by increasing life expectancy and continuing growth in the older fraction of the population. There is remarkably little up-to-date information about the health of the oldest old (over 85 years, demographically the fastest growing section of the population. There is a need, from both a policy and scientific perspective, to describe in detail the health status of this population and the factors that influence individual health trajectories. For a very large proportion of medical conditions, age is the single largest risk factor. Gaining new knowledge about why aged cells and tissues are more vulnerable to pathology is likely to catalyse radical new insights and opportunities to intervene. The aims of the Newcastle 85+ Study are to expose the spectrum of health within an inception cohort of 800 85 year-olds; to examine health trajectories and outcomes as the cohort ages and their associations with underlying biological, medical and social factors; and to advance understanding of the biological nature of ageing. Methods A cohort of 800 85 year olds from Newcastle and North Tyneside will be recruited at baseline and followed until the last participant has died. Eligible individuals will be all those who turn 85 during the year 2006 (i.e. born in 1921 and who are registered with a Newcastle or North Tyneside general practice. Participants will be visited in their current residence (own home or institution by a research nurse at baseline, 18 months and 36 months. The assessment protocol entails a detailed multi-dimensional health assessment together with review of general practice medical records. Participants will be flagged with the NHS Central Register to provide details of the date and cause of death. Discussion The Newcastle 85+ Study will address key questions about health and health-maintenance in the

  6. Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial

    OpenAIRE

    Tully, Phillip J; Turnbull, Deborah A; Horowitz, John D; Beltrame, John F.; Selkow, Terina; Baune, Bernhard T; Markwick, Elizabeth; Sauer-Zavala, Shannon; Baumeister, Harald; Cosh, Suzanne; Gary A Wittert

    2016-01-01

    Background Previous psychological and pharmacological interventions have primarily focused on depression disorders in populations with cardiovascular diseases (CVDs) and the efficacy of anxiety disorder interventions is only more recently being explored. Transdiagnostic interventions address common emotional processes and the full range of anxiety and depression disorders often observed in populations with CVDs. The aim of CHAMPS is to evaluate the feasibility of a unified protocol (UP) for t...

  7. The Bakery Protocol: A Comparative Case-Study in Formal Verification

    NARCIS (Netherlands)

    Griffioen, D.; Korver, H.

    2008-01-01

    Groote and the second author verified (a version of) the Bakery Protocol in μCRL. Their process-algebraic verification is rather complex compared to the protocol. Now the question is: How do other verification techniques perform on this protocol? In this paper we present a new correctness proof by u

  8. Comparison between stress myocardial perfusion SPECT recorded with cadmium-zinc-telluride and Anger cameras in various study protocols

    Energy Technology Data Exchange (ETDEWEB)

    Verger, Antoine; Karcher, Gilles [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); INSERM U947, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Djaballah, Wassila [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); INSERM U947, Nancy (France); Fourquet, Nicolas [Clinique Pasteur, Toulouse (France); Rouzet, Francois; Le Guludec, Dominique [AP-HP, Hopital Bichat, Department of Nuclear Medicine, Paris (France); INSERM U 773 Inserm and Denis Diderot University, Paris (France); Koehl, Gregoire; Roch, Veronique [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Imbert, Laetitia [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Centre Alexis Vautrin, Department of Radiotherapy, Vandoeuvre (France); Poussier, Sylvain [INSERM U947, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Fay, Renaud [INSERM, Centre d' Investigation Clinique CIC-P 9501, Nancy (France); Marie, Pierre-Yves [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); INSERM U961, Nancy (France); Hopital de Brabois, CHU-Nancy, Medecine Nucleaire, Vandoeuvre-les-Nancy (France)

    2013-03-15

    The results of stress myocardial perfusion SPECT could be enhanced by new cadmium-zinc-telluride (CZT) cameras, although differences compared to the results with conventional Anger cameras remain poorly known for most study protocols. This study was aimed at comparing the results of CZT and Anger SPECT according to various study protocols while taking into account the influence of obesity. The study population, which was from three different institutions equipped with identical CZT cameras, comprised 276 patients referred for study using protocols involving {sup 201}Tl (n = 120) or {sup 99m}Tc-sestamibi injected at low dose at stress ({sup 99m}Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ({sup 99m}Tc-High; rest/stress 1-day or 2-day protocol; n = 46). Each Anger SPECT scan was followed by a high-speed CZT SPECT scan (2 to 4 min). Agreement rates between CZT and Anger SPECT were good irrespective of the study protocol (for abnormal SPECT, {sup 201}Tl 92 %, {sup 99m}Tc-Low 86 %, {sup 99m}Tc-High 98 %), although quality scores were much higher for CZT SPECT with all study protocols. Overall correlations were high for the extent of myocardial infarction (r = 0.80) and a little lower for ischaemic areas (r = 0.72), the latter being larger on Anger SPECT (p < 0.001). This larger extent was mainly observed in 50 obese patients who were in the {sup 201}Tl or {sup 99m}Tc-Low group and in whom stress myocardial counts were particularly low with Anger SPECT (228 {+-} 101 kcounts) and dramatically enhanced with CZT SPECT (+279 {+-} 251 %). Concordance between the results of CZT and Anger SPECT is good regardless of study protocol and especially when excluding obese patients who have low-count Anger SPECT and for whom myocardial counts are dramatically enhanced on CZT SPECT. (orig.)

  9. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    Science.gov (United States)

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field. PMID:26248094

  10. Synchrotron radiation X-ray micro-fluorescence: Protocol to study mesenchymal stem cells.

    Science.gov (United States)

    Rezende, Karla Mayra; Bönecker, Marcelo; Perez, Carlos Alberto; Mantesso, Andrea

    2016-03-01

    The micro-X-ray fluorescence by synchrotron radiation (μ-XRF) is a method to determine the composition of tissues without destroying the samples. However, this technique has never been used for the analysis of mesenchymal stem cells (MSC). This study compared different protocols for fixing, storing, preserving, and establishing the correct numbers of dental derived MSC submitted to μ-XRF analysis. Stem cells were obtained from human dental tissue. After cell expansion, and MACS isolation, the samples were fixed and the following quantities of cells 1 × 10(4) to 1 × 10(7) were divided in two groups: G1: fixed in 4% paraformaldehyde diluted in phosphate-buffered saline solution, and G2: fixed in 4% paraformaldehyde diluted in MilliQ water. The G1 cells showed precipitation of chemical components from the solution resulting in the formation of salt crystals while G2 cells were clear and almost transparent in the sample holder. With regards to cells concentration, the best results occurred when four droplets of 1 × 10(7) cells were analyzed. This work shows that to identify and study the distribution of trace elements in MSC by μ-XRF, the best protocol is fixation in 4% paraformaldehyde diluted with MilliQ water at 4°C and a concentration of four incremental droplets of 1 × 10(7) cells. PMID:26749077

  11. Simulation Studies On An Energy Efficient Multipath Routing Protocol Using Directional Antennas For Manets

    Directory of Open Access Journals (Sweden)

    Sandhya Chilukuri

    2012-09-01

    Full Text Available The paper proposes the development of an energy efficient multipath routing protocol with directional antenna for MANET as an optimization task as well as a multidisciplinary entity. A comprehensive analysis to link all the multi-disciplinary viewpoints involved in the development of desired multipath routing protocol with requisite technical details is presented in this paper. A simple and elegant mathematical formulation for the analysis of relative improvement of the performance metrics of ad-hocnetworks with omnidirectional and directional antenna is presented. Through extensive numerical simulations, the multi-dimensional desirable performance attributes of wireless link such as improvedrange, improved RSS, reduced RF transmit power and consequent reduced consumption of battery power have been analyzed keeping the directional gain of the antenna as a variable parameter. Development or modification of a protocol with concurrent focus on multipath routing with optimization of the batteryenergy is a significant step to increase the life time of MANET without recharging. Selection of the energy efficient path amongst several alternative ones is of paramount significance in the evaluation of overall performance of MANET system. A formulation to compute the required Battery Energy taking into account the data pertaining to the power efficiency of the associated transceiver design as well as the specified link performance parameters is also discussed. Through a case study involving the specifications of a typical transceiver operating in the 2.4 GHz band, the desirable impact of higher gain of a directional antenna in the reduction of RF transmitter power is illustrated. The consequential reduced battery power consumption while still retaining the specified performance parameters of the adhoc network like range and Received Signal Strength (RSS is also demonstrated. This paper also addresses the importance of alignment of beam peaks of directional

  12. Protocol for studying extinction of conditioned fear in naturally cycling female rats.

    Science.gov (United States)

    Maeng, Lisa Y; Cover, Kara K; Landau, Aaron J; Milad, Mohammed R; Lebron-Milad, Kelimer

    2015-01-01

    Extinction of conditioned fear has been extensively studied in male rodents. Recently, there have been an increasing number of studies indicating that neural mechanisms for certain behavioral tasks and response behaviors are different in females and males. Using females in research studies can represent a challenge because of the variation of gonadal hormones during their estrous cycle. This protocol describes well-established procedures that are useful in investigating the role of estrogen in fear extinction memory consolidation in female rats. Phase of the estrous cycle and exogenous estrogen administration prior to extinction training can influence extinction recall 24 hr later. The vaginal swabbing technique for estrous phase identification described here aids the examination and manipulation of naturally cycling gonadal hormones. The use of this basic rodent model may further delineate the mechanisms by which estrogen can modulate fear extinction memory in females. PMID:25741747

  13. A PROSPECTIVE STUDY OF 97 CASES TO ARRIVE AT TREATMENT PROTOCOLS FOR FLOATING KNEE

    Directory of Open Access Journals (Sweden)

    Prasad

    2015-03-01

    Full Text Available BACKGROUND : Floating knee is an injury in which fractures are present both above and below isolating it. It’s a high velocity injury 1 f requently associated with multiple fractures and injuries to other organs . ² The management i.e. , timing of surgery , no of incisions and the type of implants is still a gray area as several protocols have been advocated. MATERIALS AND METHODS : This study comprises of 97 cases and was conducted in the two tertiary care hospitals of Hyderabad , during a period of 6 yrs i.e. , between 2007 - 2013. The average of the patients is 28.2 years and the Male to Female ratio is 6:1 , there were 68 open fractur es. Each case is individually assessed and managed. Different implants are used to fix these fractures depending upon the situation and fracture type. RESULTS : All the cases are evaluated after fracture union based on criteria Karlstrom and Olerud. Sixty f ive patients had union of femoral and tibial fractures with 90 degrees of knee flexion falling into the category of excellent and good results. Complications encountered were Infection , Knee - stiffness , nonunion , malunion , injury to nerves. CONCLUSIONS : The re is no fixed protocol in the number of incisions , choice of fixation device , and timing of surgery in the management of floating knee injuries. Each case should be dealt with basing on its merits. The management should be tailor - made for that particular case.

  14. A multi-parametric protocol to study exercise intolerance in McArdle's disease.

    Science.gov (United States)

    Ricci, Giulia; Bertolucci, Federica; Logerfo, Annalisa; Simoncini, Costanza; Papi, Riccardo; Franzoni, Ferdinando; Dell'Osso, Giacomo; Servadio, Adele; Masoni, Maria Chiara; Siciliano, Gabriele

    2015-12-01

    McArdle's disease is the most common metabolic myopathy of muscle carbohydrate metabolism, due to deficiency of myophosphorylase and alteration of glycogen breakdown in muscle. The clinical manifestations usually begin in young adulthood, with exercise intolerance, exercise-induced muscle cramps, pain and recurrent episodes of myoglobinuria. Many patients experience the second wind phenomenon, characterized by an improved tolerance for aerobic exercise approximately after eight minutes of motor activity, secondary to the increased availability of blood glucose and free fatty acids associated to an enhanced glucose uptake by muscle cells. In this study, we aimed to test a multi-parametric protocol in order to detect the impairment of muscular metabolism and motor performance in patients with McArdle's disease. We enrolled 5 patients and 5 age-matched healthy subjects, that were evaluated by: (01) monitoring of physical activity with an electronic armband; (02) testing of cardiopulmonary, metabolic and respiratory responses to exercise with a cardiopulmonary exercise test and analyzing muscle fatigue during exercise test by surface electromyography (04) evaluating blood lactate and oxidative stress biomarkers at rest and during exercise. The patients were tested at baseline and after three days of carbohydrate-rich diet integrated with tricarboxylic acid cycle intermediate and creatine. The multiparametric protocol proved to be useful to detect the oxidative capacity impairment and the second wind phenomenon of patients. We did not observe any significant differences of muscle metabolic response during the exercise test after three days of carbohydrate-rich diet. PMID:27199539

  15. 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

  16. Optimization of the scan protocols for CT-based material extraction in small animal PET/CT studies

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Ching-Ching [Department of Medical Imaging and Radiological Sciences, Tzu Chi College of Technology, 880, Sec 2, Chien-Kuo Rd., Hualien, Taiwan (China); Yu, Jhih-An [Department of Biomedical Imaging and Radiological Sciences, National Yang-Ming University, 155 Li-Nong St., Sec. 2, Taipei, Taiwan (China); Yang, Bang-Hung [Department of Biomedical Imaging and Radiological Sciences, National Yang-Ming University, 155 Li-Nong St., Sec. 2, Taipei, Taiwan (China); Department of Nuclear Medicine, Taipei Veterans General Hospital, Taipei, Taiwan (China); Wu, Tung-Hsin, E-mail: tung@ym.edu.tw [Department of Biomedical Imaging and Radiological Sciences, National Yang-Ming University, 155 Li-Nong St., Sec. 2, Taipei, Taiwan (China)

    2013-12-11

    We investigated the effects of scan protocols on CT-based material extraction to minimize radiation dose while maintaining sufficient image information in small animal studies. The phantom simulation experiments were performed with the high dose (HD), medium dose (MD) and low dose (LD) protocols at 50, 70 and 80 kV{sub p} with varying mA s. The reconstructed CT images were segmented based on Hounsfield unit (HU)-physical density (ρ) calibration curves and the dual-energy CT-based (DECT) method. Compared to the (HU;ρ) method performed on CT images acquired with the 80 kV{sub p} HD protocol, a 2-fold improvement in segmentation accuracy and a 7.5-fold reduction in radiation dose were observed when the DECT method was performed on CT images acquired with the 50/80 kV{sub p} LD protocol, showing the possibility to reduce radiation dose while achieving high segmentation accuracy.

  17. A Study on the Distributed Antenna Based Heterogeneous Cognitive Wireless Network Synchronous MAC Protocol

    Directory of Open Access Journals (Sweden)

    Lian-Fen Huang

    2015-01-01

    Full Text Available This paper introduces distributed antennas into a cognitive radio network and presents a heterogeneous network. The best contribution of this paper is that it designs a synchronous cognitive MAC protocol (DAHCWNS-MAC protocol: distributed antenna based heterogeneous cognitive wireless network synchronous MAC protocol. The novel protocol aims at combining the advantages of cognitive radio and distributed antennas to fully utilize the licensed spectrum, broaden the communication range, and improve throughput. This paper carries out the mathematical modeling and performance simulation to demonstrate its superiority in improving the network throughput at the cost of increasing antenna hardware costs.

  18. National validation study of a swab protocol for the recovery of Bacillus anthracis spores from surfaces.

    Science.gov (United States)

    Hodges, Lisa R; Rose, Laura J; O'Connell, Heather; Arduino, Matthew J

    2010-05-01

    Twelve Laboratory Response Network (LRN) affiliated laboratories participated in a validation study of a macrofoam swab protocol for the recovery, detection, and quantification of viable B. anthracis (BA) Sterne spores from steel surfaces. CDC personnel inoculated steel coupons (26cm(2)) with 1-4 log(10) BA spores and recovered them by sampling with pre-moistened macrofoam swabs. Phase 1 (P1) of the study evaluated swabs containing BA only, while dust and background organisms were added to swabs in Phase 2 (P2) to mimic environmental conditions. Laboratories processed swabs and enumerated spores by culturing eluted swab suspensions and counting colonies with morphology consistent with BA. Processed swabs were placed in enrichment broth, incubated 24h, and cultured by streaking for isolation. Real-time PCR was performed on selected colonies from P2 samples to confirm the identity of BA. Mean percent recovery (%R) of spores from the surface ranged from 15.8 to 31.0% (P1) and from 27.9 to 55.0% (P2). The highest mean percent recovery was 31.0% (sd 10.9%) for P1 (4 log(10) inoculum) and 55.0% (sd 27.6%) for P2 (1 log(10) inoculum). The overall %R was higher for P2 (44.6%) than P1 (24.1%), but the overall reproducibility (between-lab variability) was lower in P2 than in P1 (25.0 vs 16.5%CV, respectively). The overall precision (within-lab variability) was close to identical for P1 and P2 (44.0 and 44.1, respectively), but varied greatly between inoculum levels. The protocol demonstrated linearity in %R over the three inoculum levels and is able to detect between 26 and 5x10(6)spores/26cm(2). Sensitivity as determined by culture was >98.3% for both phases and all inocula, suggesting that the culture method maintains sensitivity in the presence of contaminants. The enrichment broth method alone was less sensitive for sampled swabs (66.4%) during P2, suggesting that the presence of background organisms inhibited growth or isolation of BA from the broth. The addition of

  19. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol

    Science.gov (United States)

    Furberg, Robert D; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-01-01

    Background Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Objective Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. Methods The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care–related infections were reviewed to develop the infection control protocol to support tablet maintenance. Results This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. Conclusions These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings. PMID:27350013

  20. Optimal protocol for teleconsultation with a cellular phone for dentoalveolar trauma: an in-vitro study

    International Nuclear Information System (INIS)

    Dental trauma is frequently unpredictable. The initial assessment and urgent treatment are essential for dentists to save the patient's teeth. Mobile-phone-assisted teleconsultation and telediagnosis for dental trauma could be an aid when a dentist is not available. In the present in-vitro study, we evaluated the success rate and time to transfer images under various conditions. We analyzed the image quality of cameras built into mobile phones based on their resolution, autofocus, white-balance, and anti-movement functions. The image quality of most built-in cameras was acceptable to perform the initial assessment, with the autofocus function being essential to obtain high-quality images. The transmission failure rate increased markedly when the image size exceeded 500 kB and the additional text messaging did not improve the success rate or the transmission time. Our optimal protocol could be useful for emergency programs running on the mobile phones.

  1. Optimal protocol for teleconsultation with a cellular phone for dentoalveolar trauma: an in-vitro study

    Energy Technology Data Exchange (ETDEWEB)

    Park, Won Se; Lee, Hae Na; Jeong, Jin Sun; Kwon, Jung Hoon; Lee, Grace H; Kim, Kee Dong [College of Dentistry, Yonsei University, Seoul (Korea, Republic of)

    2012-06-15

    Dental trauma is frequently unpredictable. The initial assessment and urgent treatment are essential for dentists to save the patient's teeth. Mobile-phone-assisted teleconsultation and telediagnosis for dental trauma could be an aid when a dentist is not available. In the present in-vitro study, we evaluated the success rate and time to transfer images under various conditions. We analyzed the image quality of cameras built into mobile phones based on their resolution, autofocus, white-balance, and anti-movement functions. The image quality of most built-in cameras was acceptable to perform the initial assessment, with the autofocus function being essential to obtain high-quality images. The transmission failure rate increased markedly when the image size exceeded 500 kB and the additional text messaging did not improve the success rate or the transmission time. Our optimal protocol could be useful for emergency programs running on the mobile phones.

  2. Burnout among chiropractic practitioners: real or imagined an exploratory study protocol.

    Science.gov (United States)

    Williams, Shawn; Innes, Stanley

    2012-01-01

    Burnout is a psychological syndrome of emotional exhaustion, depersonalization and reduced personal accomplishment that has been found to exist in a significant number of healthcare and helping professionals. It imposes a significant societal burden by shortened practitioner lifespan, decreased efficiency, negative health outcomes and poorer levels of patient care. Theoretical models suggest that it appears to be the result of a complex interaction between job resources and job demands. It may be reasonable to conclude that Chiropractic professionals experience similar vocational demands and thus experience significant levels of occupational stress and subsequent burnout. However the data on burnout within the chiropractic profession is limited. It is possible that this results in significant negative outcomes on chiropractors and their patients. Therefore, the objective of this paper is to demonstrate the need to explore burnout in chiropractic practice and offer a research protocol for a potential study. PMID:22369737

  3. Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Schayck Onno CP

    2009-12-01

    Full Text Available Abstract Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette, susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline. Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465

  4. A Bounded Retransmission Protocol for Large Data Packets: A Case Study in Computer Checked Algebraic Verification

    NARCIS (Netherlands)

    Groote, J.F.; Pol, J. van de

    2008-01-01

    This note describes a protocol for the transmission of data packets that are too large to be transferred in their entirety. Therefore, the protocol splits the data packets and broadcasts it in parts. It is assumed that in case of failure of transmission through data channels, only a limited number o

  5. An Empirical Study and some Improvements of the MiniMac Protocol for Secure Computation

    DEFF Research Database (Denmark)

    Damgård, Ivan Bjerre; Lauritsen, Rasmus; Toft, Tomas

    2014-01-01

    suggest a modification of MiniMac that achieves increased parallelism at no extra communication cost. This gives an asymptotic improvement of the original protocol as well as an 8-fold speed-up of our implementation. We compare the resulting protocol to TinyOT for the case of secure computation in parallel...

  6. Study of effective dose of various protocols in equipment cone beam CT

    Energy Technology Data Exchange (ETDEWEB)

    Soares, M. R.; Maia, A. F. [Universidade Federale de Sergipe, Departamento de Fisica, Cidade Universitaria Prof. Jose Aloisio de Campos, Marechal Rondon s/n, Jardim Rosa Elze, 49-100000 Sao Cristovao, Sergipe (Brazil); Batista, W. O. [Instituto Federal da Bahia, Rua Emidio dos Santos s/n, Barbalho, Salvador, 40301015 Bahia (Brazil); Caldas, L. V. E.; Lara, P. A., E-mail: mrs2206@gmail.com [Instituto de Pesquisas Energeticas e Nucleares / CNEN, Av. Lineu Prestes 2242, Cidade Universitaria, 05508-000 Sao Paulo (Brazil)

    2014-08-15

    Currently the cone beam computed tomography is widely used in various procedures of dental radiology. Although the doses values associated with the procedures of cone beam CT are low compared to typical values associated with dental radiology procedure in multi slices CT. However can be high compared to typical values of other techniques commonly used in dental radiology. The present scenario is a very wide range of designs of equipment and, consequently, lack of uniformity in all parameters associated with x-ray generation and geometry. In this context, this study aimed to evaluate and calculate the absorbed dose in organs and tissues relevant and estimate effective dose for different protocols with different geometries of exposure in five cone beam CT equipment. For this, a female Alderson anthropomorphic phantom, manufactured by Radiology Support Devices was used. The phantom was irradiated with 26 dosimeters LiF: Mg, Ti (TLD-100), inserted in organs and tissues along the layers forming the head and neck of the phantom. The equipment used, in this present assessment, was: i-CAT Classical, Kodak 9000 3D, Gendex GXCB 500, Sirona Orthophos X G 3D and Planmeca Pro Max 3D. The effective doses were be determined by the ICRP 103 weighting factors. The values were between 7.0 and 111.5 micro Sv, confirming the broad dose range expected due to the diversity of equipment and protocols used in each equipment. The values of effective dose per Fov size were: between 7 and 51.2 micro Sv for located Fov; between 17.6 and 52.0 micro Sv for medium Fov; and between 11.5 and 43.1 micro Sv to large Fov (maxillofacial). In obtaining the effective dose the measurements highlighted a relevance contribution of dose absorbed by the remaining organs (36%), Salivary glands (30%), thyroid (12%) and bone marrow (12%). (Author)

  7. Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol

    Directory of Open Access Journals (Sweden)

    van der Vlugt Maureen J

    2011-02-01

    Full Text Available Abstract Background Cerebral small vessel disease (SVD is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects with SVD become demented or get parkinsonism. This might be explained by the diversity of underlying pathology of both white matter lesions (WML and the normal appearing white matter (NAWM. Both cannot be properly appreciated with conventional MRI. Diffusion tensor imaging (DTI provides alternative information on microstructural white matter integrity. The association between SVD, its microstructural integrity, and incident dementia and parkinsonism has never been investigated. Methods/Design The RUN DMC study is a prospective cohort study on the risk factors and cognitive and motor consequences of brain changes among 503 non-demented elderly, aged between 50-85 years, with cerebral SVD. First follow up is being prepared for July 2011. Participants alive will be included and invited to the research centre to undergo a structured questionnaire on demographics and vascular risk factors, and a cognitive, and motor, assessment, followed by a MRI protocol including conventional MRI, DTI and resting state fMRI. Discussion The follow up of the RUN DMC study has the potential to further unravel the causes and possibly better predict the consequences of changes in white matter integrity in elderly with SVD by using relatively new imaging techniques. When proven, these changes might function as a surrogate endpoint for cognitive and motor function in future therapeutic trials. Our data could furthermore provide a better understanding of the pathophysiology of cognitive and motor disturbances in elderly with SVD. The execution and completion of the follow up of our study might ultimately unravel the role of SVD on the microstructural integrity of the white

  8. A Protocol for the Longitudinal Study of Psychological Resilience in the Australian Defence Force

    Directory of Open Access Journals (Sweden)

    Monique F. Crane

    2012-11-01

    Full Text Available In the last two decades there has been increasing attention directed at the analysis of psychological resilience. The number of modern-day veterans returning from Iraq and Afghanistan has sparked great interest in identifying mechanisms that can either erode or facilitate psychological resilience. In November 2009, the Australian Defence Force (ADF in collaboration with the Australian Centre for Post-traumatic Mental Health (ACPMH launched a longitudinal study of psychological resilience dubbed LASER (Longitudinal ADF Study Examining Resilience. The study is anticipated to inform psychological resilience training and mental health policy within the ADF. The purpose of the present paper is four-fold. First, this paper will outline the operational definition of psychological resilience used by the ADF. Second, we describe previous findings on psychological resilience while examining how these findings are limited by cross-sectional design. Third, this paper will review previous resilience methodology and discuss the merits of a longitudinal methodology. Fourth, this paper will describe the LASER study protocol, key challenges and implemented solutions.

  9. Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hayes Loran P

    2011-05-01

    Full Text Available Abstract Background This protocol is for a study of a new program to improve outcomes in children suffering from chronic pain disorders, such as fibromyalgia, recurrent headache, or recurrent abdominal pain. Although teaching active pain self-management skills through cognitive-behavioral therapy (CBT or a complementary program such as hypnotherapy or yoga has been shown to improve pain and functioning, children with low expectations of skill-building programs may lack motivation to comply with therapists' recommendations. This study will develop and test a new manualized peer-mentorship program which will provide modeling and reinforcement by peers to other adolescents with chronic pain (the mentored participants. The mentorship program will encourage mentored participants to engage in therapies that promote the learning of pain self-management skills and to support the mentored participants' practice of these skills. The study will examine the feasibility of this intervention for both mentors and mentored participants, and will assess the preliminary effectiveness of this program on mentored participants' pain and functional disability. Methods This protocol will recruit adolescents ages 12-17 with chronic pain and randomly assign them to either peer mentorship or a treatment-as-usual control group. Mentored participants will be matched with peer mentors of similar age (ages 14-18 who have actively participated in various treatment modalities through the UCLA Pediatric Pain Program and have learned to function successfully with a chronic pain disorder. The mentors will present information to mentored participants in a supervised and monitored telephone interaction for 2 months to encourage participation in skill-building programs. The control group will receive usual care but without the mentorship intervention. Mentored and control subjects' pain and functioning will be assessed at 2 months (end of intervention for mentored participants and

  10. The Impact of a Surgical Protocol for Enhanced Recovery on Living Donor Right Hepatectomy: A Single-Center Cohort Study.

    Science.gov (United States)

    Kim, Seong Hoon; Kim, Young Kyu; Lee, Seung Duk; Lee, Eung Chang; Park, Sang Jae

    2016-04-01

    The concept of surgery for enhanced recovery (SFER) program has never been an issue in the context of living donor right hepatectomy (LDRH), much less its effects. The purpose of this study was to evaluate outcomes after the establishment of an SFER protocol for LDRH in a single center.A single-center cohort study was performed in 500 consecutive living donors who underwent right hepatectomy from January 2005 to June 2014 by analyzing the outcomes before and after an established SFER protocol that evolved with continuous refinements in surgical technique and management over 300 LDRHs, being in place on September 2011. Donor characteristics, operative outcomes, and postoperative complications divided into 2 groups (group 1, stepwise adjustment; group 2, complete adherence to the protocol) were compared.Donor characteristics were comparable in the 2 groups. Overall complication rate was 10.0% with no mortality. In group 2, operative time, hospital stay, and overall complication rate decreased significantly, and the morbidity was 1% and confined in grade I complication without reoperation, perioperative blood transfusion, or readmission. All donors in this series recovered fully and returned to the previous functional lifestyle.An SFER protocol on LDRH can be established by the gradual implementation of various refinements of surgical technique, and the recent outcomes achieved after the establishment of an SFER protocol could provide a current guidance on LDRH toward the ultimate goal of zero morbidity. PMID:27057855

  11. Histomorphometric assessment of bone necrosis produced by two cryosurgery protocols using liquid nitrogen: an experimental study on rat femurs

    Directory of Open Access Journals (Sweden)

    Fábio Wildson Gurgel Costa

    2011-12-01

    Full Text Available OBJECTIVE: The aim of this study was to evaluate the effects of liquid nitrogen cryosurgery on the femoral diaphysis of rats. MATERIAL AND METHODS: The femoral diaphyses of 42 Wistar rats were exposed to three local and sequential applications of liquid nitrogen for 1 or 2 min, intercalated with periods of 5 min of passive thawing. The animals were sacrificed after 1, 2, 4 and 12 weeks and the specimens obtained were processed and analyzed histomorphometrically. RESULTS: The depth and extent of peak bone necrosis were 124.509 µm and 2087.094 µm for the 1-min protocol, respectively, and 436.424 µm and 12046.426 µm for the 2-min protocol. Peak necrosis was observed in the second experimental week with both cryotherapy protocols. CONCLUSIONS: The present results indicate that the 2-min protocol produced more marked bone necrosis than the 1-min protocol. Although our results cannot be entirely extrapolated to clinical practice, they contribute to the understanding of the behavior of bone tissue submitted to different cycles of liquid nitrogen freezing and may serve as a basis for new studies.

  12. Analysis of efficiency of the double- centrifugation protocol to prepare platelet rich plasma (PRP – an experimental study in rabbits

    Directory of Open Access Journals (Sweden)

    Michel Reis MESSORA

    2009-09-01

    Full Text Available Introduction and objective:The purpose of this study was to evaluatethe concentrations of platelets obtained from platelet rich plasma (PRP prepared according to the double-centrifugation protocol. Material and methods: Eight adult male rabbits (White New Zealand weighing 2.8 to 4 kg were used.After general anesthesia, 10 ml of blood were drawn from each animal via cardiac puncture. Each blood sample was centrifuged according to the protocol of Sonnleitner et al.(2000.The peripheral blood (total from each animal and the PRP samples platelets were counted manually. Data were submitted to statistical analysis.The normality of the data was confirmed and the Student’s t test was applied (p < 0.05.Results: PRP samples presented an average platele count significantly higher than that of peripheral blood.Conclusion Within the limits of this study, it was concluded that the double centrifugation protocol was adequate to prepare PRP .

  13. Cottonwood data collection protocol : Great Sand Dunes National Park : Elk/Bison grazing ecology study

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This protocol/SOP is from USGS to estimate percent consumption of cottonwood saplings, seedlings, and resprouts and recruitment rates of cottonwood subjected to...

  14. Protocol adaptations to conduct Systematic Literature Reviews in Software Engineering: a chronological study

    Directory of Open Access Journals (Sweden)

    Samuel Sepúlveda

    2015-12-01

    Full Text Available Systematic literature reviews (SLR have reached a considerable level of adoption in Software Engineering (SE, how-ever protocol adaptations for its implementation remain tangentially addressed. This work provides a chronological framework for the use and adaptation of the SLR protocol, including its current status. A systematic literature search was performed, reviewing a set of twelve articles being selected in accordance with the inclusion and exclusion criteria between 2004 and 2013, using digital data sources recognized by the SE community. A chronological framework is provided that includes the current state of the protocol adaptations to conduct SLR in SE. The results indicate areas where the quantity and quality of investigations needs to be increased and the identi- fication of the main proposals providing adaptations for the protocol conducting SLR in SE.

  15. The Study of MSADQ/CDMA Protocol in Voice/Data Integration Packet Networks

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    A new packet medium access protocol, namely, minislot signalingaccess based on distributed queues(MSADQ/CDMA), is proposed in voice and data intergration CDMA networks. The MSADQ protocol is based on distributed queues and collision resolution algorithm. Through proper management of the PN codes, the number of random competition collision reduces greatly, the multiple access interference (MAI) decreases. It has several special access signaling channels to carry the voice and data access request. Each slot is devided into several control minislots (CMSs), in which the Data Terminals (DT) or Voice Terminals (VT) transmit their request. According to the voice and data traffic character, the signaling access structure is proposed. The code assign rules and queue managing rules are also proposed to ensure the QoS requirement of each traffic. Comparisions with other three protocol are developed by simulation, which shows that MSADQ/CDMA protocol occupies less PN codes, but still has very good performance.

  16. Formal security analysis of registration protocols for interactive systems: a methodology and a case of study

    CERN Document Server

    Diaz, Jesus; Rodriguez, Francisco B

    2012-01-01

    In this work we present and formally analyze CHAT-SRP (CHAos based Tickets-Secure Registration Protocol), a protocol to provide interactive and collaborative platforms with a cryptographically robust solution to classical security issues. Namely, we focus on the secrecy and authenticity properties while keeping a high usability. Indeed, most interactive platforms currently base their security properties almost exclusively on the correct implementation and configuration of the systems. In this sense, users are forced to blindly trust the system administrators and developers. Moreover, as far as we know, there is a lack of formal methodologies for the verification of security properties for interactive applications. We propose here a methodology to fill this gap, i.e., to analyse both the security of the proposed protocol and the pertinence of the underlying premises. In this concern, we propose the definition and formal evaluation of a protocol for the distribution of digital identities. Once distributed, thes...

  17. Study of Flat - Reactive On-Demand Routing Protocol (DSR & AODV): A Review

    OpenAIRE

    Atul D.Atalkar; Prof. Prashant S.Wankhede

    2014-01-01

    Mobile Ad-Hoc Network is a collection of mobile node, which communicates with each other to share information among them. Each node acts as a router itself. They are freely to move and change their position within a network and arrange themselves share all resources with each other. But to share information a routing protocol is needed. Routing protocol plays an important role in network design and provides the simplicity, decision rights to network, which will increase the perfor...

  18. Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jimin Park

    2015-01-01

    Full Text Available Background. Atrial fibrillation (AF is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF. Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA and left atrial appendage (LAA changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs of Kyung Hee University Hospital (number 1335-04. This trial is registered with clinicaltrials.gov NCT02110537.

  19. Early signaling, referral, and treatment of adolescent chronic pain: a study protocol

    Directory of Open Access Journals (Sweden)

    Voerman Jessica S

    2012-06-01

    Full Text Available Abstract Background Chronic pain is prevalent among young people and negatively influences their quality of life. Furthermore, chronic pain in adolescence may persist into adulthood. Therefore, it is important early on to promote the self-management skills of adolescents with chronic pain by improving signaling, referral, and treatment of these youngsters. In this study protocol we describe the designs of two complementary studies: a signaling study and an intervention study. Methods and design The signaling study evaluates the Pain Barometer, a self-assessed signaling instrument for chronic pain in adolescents. To evaluate the feasibility of the Pain Barometer, the experiences of youth-health care nurses will be evaluated in semi-structured interviews. Also, we will explore the frequencies of referral per health-care provider. The intervention study evaluates Move It Now, a guided self-help intervention via the Internet for teenagers with chronic pain. This intervention uses cognitive behavioural techniques, including relaxation exercises and positive thinking. The objective of the intervention is to improve the ability of adolescents to cope with pain. The efficacy of Move It Now will be examined in a randomized controlled trial, in which 60 adolescents will be randomly assigned to an experimental condition or a waiting list control condition. Discussion If the Pain Barometer is proven to be feasible and Move It Now appears to be efficacious, a health care pathway can be created to provide the best tailored treatment promptly to adolescents with chronic pain. Move It Now can be easily implemented throughout the Netherlands, as the intervention is Internet based. Trial registration Dutch Trial Register NTR1926

  20. A study protocol to evaluate the relationship between outdoor air pollution and pregnancy outcomes

    Directory of Open Access Journals (Sweden)

    Selemane Ismael

    2010-10-01

    Full Text Available Abstract Background The present study protocol is designed to assess the relationship between outdoor air pollution and low birth weight and preterm births outcomes performing a semi-ecological analysis. Semi-ecological design studies are widely used to assess effects of air pollution in humans. In this type of analysis, health outcomes and covariates are measured in individuals and exposure assignments are usually based on air quality monitor stations. Therefore, estimating individual exposures are one of the major challenges when investigating these relationships with a semi-ecologic design. Methods/Design Semi-ecologic study consisting of a retrospective cohort study with ecologic assignment of exposure is applied. Health outcomes and covariates are collected at Primary Health Care Center. Data from pregnant registry, clinical record and specific questionnaire administered orally to the mothers of children born in period 2007-2010 in Portuguese Alentejo Litoral region, are collected by the research team. Outdoor air pollution data are collected with a lichen diversity biomonitoring program, and individual pregnancy exposures are assessed with spatial geostatistical simulation, which provides the basis for uncertainty analysis of individual exposures. Awareness of outdoor air pollution uncertainty will improve validity of individual exposures assignments for further statistical analysis with multivariate regression models. Discussion Exposure misclassification is an issue of concern in semi-ecological design. In this study, personal exposures are assigned to each pregnant using geocoded addresses data. A stochastic simulation method is applied to lichen diversity values index measured at biomonitoring survey locations, in order to assess spatial uncertainty of lichen diversity value index at each geocoded address. These methods assume a model for spatial autocorrelation of exposure and provide a distribution of exposures in each study location

  1. Wean Earlier and Automatically with New technology (the WEAN study: a protocol of a multicentre, pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lessard Martin R

    2009-09-01

    Full Text Available Abstract Background Weaning is the process during which mechanical ventilation is withdrawn and the work of breathing is transferred from the ventilator back to the patient. Prolonged weaning is associated with development of ventilator-related complications and longer stays in the Intensive Care Unit (ICU. Computerized or Automated Weaning is a novel weaning strategy that continuously measures and adapts ventilator support (by frequently measuring and averaging three breathing parameters and automatically conducts Spontaneous Breathing Trials to ascertain whether patients can resume autonomous breathing. Automated Weaning holds promise as a strategy to reduce the time spent on the ventilator, decrease ICU length of stay, and improve clinically important outcomes. Methods/Design A pilot weaning randomized controlled trial (RCT is underway in the ICUs of 8 Canadian hospitals. We will randomize 90 critically ill adults requiring invasive ventilation for at least 24 hours and identified at an early stage of the weaning process to either Automated Weaning (SmartCare™ or Protocolized Weaning. The results of a National Weaning Survey informed the design of the Protocolized Weaning arm. Both weaning protocols are operationalized in Pressure Support mode, include opportunities for Spontaneous Breathing Trials, and share a common sedation protocol, oxygen titration parameters, and extubation and reintubation criteria. The primary outcome of the WEAN study is to evaluate compliance with the proposed weaning and sedation protocols. A key secondary outcome of the pilot RCT is to evaluate clinician acceptance of the weaning and sedation protocols. Prior to initiating the WEAN Study, we conducted a run-in phase, involving two patients per centre (randomizing the first participant to either weaning strategy and assigning the second patient to the alternate strategy to ensure that participating centres could implement the weaning and sedation protocols and

  2. Acute symptoms related to air pollution in urban areas: a study protocol

    Directory of Open Access Journals (Sweden)

    Forouzanfar Mohammad

    2006-08-01

    Full Text Available Abstract Background The harmful effects of urban air pollution on general population in terms of annoying symptoms are not adequately evaluated. This is in contrast to the hospital admissions and short term mortality. The present study protocol is designed to assess the association between the level of exposure to certain ambient air pollutants and a wide range of relevant symptoms. Awareness of the impact of pollution on the population at large will make our estimates of the pertinent covert burden imposed on the society more accurate. Methods/design A cross sectional study with spatial analysis for the addresses of the participants was conducted. Data were collected via telephone interviews administered to a representative sample of civilians over age four in the city. Households were selected using random digit dialling procedures and randomization within each household was also performed to select the person to be interviewed. Levels of exposure are quantified by extrapolating the addresses of the study population over the air pollution matrix of the city at the time of the interview and also for different lag times. This information system uses the data from multiple air pollution monitoring stations in conjunction with meteorological data. General linear models are applied for statistical analysis. Discussion The important limitations of cross-sectional studies on acute effects of air pollution are personal confounders and measurement error for exposure. A wide range of confounders in this study are controlled for in the statistical analysis. Exposure error may be minimised by employing a validated geographical information system that provides accurate estimates and getting detailed information on locations of individual participants during the day. The widespread operation of open air conditioning systems in the target urban area which brings about excellent mixing of the outdoor and indoor air increases the validity of outdoor pollutants

  3. Effects of chronic inflammatory bowel diseases on left ventricular structure and function: a study protocol

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    Botti Fiorenzo

    2002-09-01

    Full Text Available Abstract Background Experimental evidences suggest an increased collagen deposition in inflammatory bowel diseases (IBD. In particular, large amounts of collagen type I, III and V have been described and correlated to the development of intestinal fibrotic lesions. No information has been available until now about the possible increased collagen deposition far from the main target organ. In the hypothesis that chronic inflammation and increased collagen metabolism are reflected also in the systemic circulation, we aimed this study to evaluate the effects on left ventricular wall structure by assessing splancnic and systemic collagen metabolism (procollagen III assay, deposition (ultrasonic tissue characterization, and cardiac function (echocardiography in patients with different long standing history of IBD, before and after surgery. Methods Thirty patients affected by active IBD, 15 with Crohn and 15 with Ulcerative Colitis, submitted to surgery will be enrolled in the study in a double blind fashion. They will be studied before the surgical operation and 6, 12 months after surgery. A control group of 15 healthy age and gender-matched subjects will also be studied. At each interval blood samples will be collected in order to assess the collagen metabolism; a transthoracic echocardiogram will be recorded for the subsequent determination of cardiac function and collagen deposition. Discussion From this study protocol we expect additional information about the association between IBD and cardiovascular disorders; in particular to address the question if chronic inflammation, through the altered collagen metabolism, could affect left ventricular structure and function in a manner directly related to the estimated duration of the disease.

  4. Acupuncture, Counseling, and Usual care for Depression (ACUDep: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MacPherson Hugh

    2012-11-01

    Full Text Available Abstract Background The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. Methods/Design Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. Participants: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II. Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. Interventions: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. Outcome: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. Analysis: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. Analysis of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will

  5. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

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    Ubbink Dirk T

    2011-10-01

    Full Text Available Abstract Background Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds. Methods A 14-center, six-armed randomized clinical trial is being carried out in the Netherlands. An a-priori power analysis and an anticipated dropout rate of 15% indicates that 50 patients per group are necessary, totaling 300 patients, to be able to detect a 25% quicker mean time to complete wound healing. Randomization has been computerized to ensure allocation concealment. Adult patients who need a split-skin grafting operation for any reason, leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings: hydrocolloid, alginate, film, hydrofiber, silicone dressing, or paraffin gauze. No combinations of products from other intervention groups in this trial are allowed. Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers. Primary outcomes are days to complete wound healing and pain (using a Visual Analogue Scale. Secondary outcomes are adverse effects, scarring, patient satisfaction, and costs. Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred. Results will be analyzed according to the intention to treat principle. The first patient was randomized October 1, 2009. Discussion This study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such

  6. Security Protocols in a Nutshell

    OpenAIRE

    Toorani, Mohsen

    2016-01-01

    Security protocols are building blocks in secure communications. They deploy some security mechanisms to provide certain security services. Security protocols are considered abstract when analyzed, but they can have extra vulnerabilities when implemented. This manuscript provides a holistic study on security protocols. It reviews foundations of security protocols, taxonomy of attacks on security protocols and their implementations, and different methods and models for security analysis of pro...

  7. Optimal Scanning Protocols for Dual-Energy CT Angiography in Peripheral Arterial Stents: An in Vitro Phantom Study

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    Abdulrahman Almutairi

    2015-05-01

    Full Text Available Objective: To identify the optimal dual-energy computed tomography (DECT scanning protocol for peripheral arterial stents while achieving a low radiation dose, while still maintaining diagnostic image quality, as determined by an in vitro phantom study. Methods: Dual-energy scans in monochromatic spectral imaging mode were performed on a peripheral arterial phantom with use of three gemstone spectral imaging (GSI protocols, three pitch values, and four kiloelectron volts (keV ranges. A total of 15 stents of different sizes, materials, and designs were deployed in the phantom. Image noise, the signal-to-noise ratio (SNR, different levels of adaptive statistical iterative reconstruction (ASIR, and the four levels of monochromatic energy for DECT imaging of peripheral arterial stents were measured and compared to determine the optimal protocols. Results: A total of 36 scans with 180 datasets were reconstructed from a combination of different protocols. There was a significant reduction of image noise with a higher SNR from monochromatic energy images between 65 and 70 keV in all investigated preset GSI protocols (p < 0.05. In addition, significant effects were found from the main effect analysis for these factors: GSI, pitch, and keV (p = 0.001. In contrast, there was significant interaction on the unstented area between GSI and ASIR (p = 0.015 and a very high significant difference between keV and ASIR (p < 0.001. A radiation dose reduction of 50% was achieved. Conclusions: The optimal scanning protocol and energy level in the phantom study were GSI-48, pitch value 0.984, and 65 keV, which resulted in lower image noise and a lower radiation dose, but with acceptable diagnostic images.

  8. Optimal Scanning Protocols for Dual-Energy CT Angiography in Peripheral Arterial Stents: An in Vitro Phantom Study

    Science.gov (United States)

    Almutairi, Abdulrahman; Sun, Zhonghua; Al Safran, Zakariya; Poovathumkadavi, Abduljaleel; Albader, Suha; Ifdailat, Husam

    2015-01-01

    Objective: To identify the optimal dual-energy computed tomography (DECT) scanning protocol for peripheral arterial stents while achieving a low radiation dose, while still maintaining diagnostic image quality, as determined by an in vitro phantom study. Methods: Dual-energy scans in monochromatic spectral imaging mode were performed on a peripheral arterial phantom with use of three gemstone spectral imaging (GSI) protocols, three pitch values, and four kiloelectron volts (keV) ranges. A total of 15 stents of different sizes, materials, and designs were deployed in the phantom. Image noise, the signal-to-noise ratio (SNR), different levels of adaptive statistical iterative reconstruction (ASIR), and the four levels of monochromatic energy for DECT imaging of peripheral arterial stents were measured and compared to determine the optimal protocols. Results: A total of 36 scans with 180 datasets were reconstructed from a combination of different protocols. There was a significant reduction of image noise with a higher SNR from monochromatic energy images between 65 and 70 keV in all investigated preset GSI protocols (p < 0.05). In addition, significant effects were found from the main effect analysis for these factors: GSI, pitch, and keV (p = 0.001). In contrast, there was significant interaction on the unstented area between GSI and ASIR (p = 0.015) and a very high significant difference between keV and ASIR (p < 0.001). A radiation dose reduction of 50% was achieved. Conclusions: The optimal scanning protocol and energy level in the phantom study were GSI-48, pitch value 0.984, and 65 keV, which resulted in lower image noise and a lower radiation dose, but with acceptable diagnostic images. PMID:26006234

  9. Desorption isotherms of cementitious materials: study of an accelerated protocol and estimation of RVE

    International Nuclear Information System (INIS)

    In the framework of French radioactive waste management and storage, the durability evaluation and prediction of concrete structures requires the knowledge of desorption isotherm of concrete. The aim of the present study is to develop an accelerated experimental method to obtain desorption isotherm of cementitious materials more quickly and to estimate the Representative Volume Element (RVE) size related to the desorption isotherm of concrete. In order to ensure that experimental results can be statistically considered representative, a great amount of sliced samples of cementitious materials with three different thicknesses (1 mm, 2 mm and 3 mm) have been de-saturated. The effect of slice thickness and the saturation condition on the mass variation kinetics and the desorption isotherms is analyzed. The influence of the aggregate distribution on the water content and the water saturation degree is also analyzed. A method based on statistical analysis of water content and water saturation degree is proposed to estimate the RVE for water desorption experiment of concrete. The evolution of shrinkage with relative humidity is also followed for each material during the water desorption experiment. A protocol of cycle of rapid desaturation-re-saturation is applied and shows the existence of hysteresis between desorption and adsorption. (author)

  10. A Pilot Study Involving the Effect of Two Different Complex Training Protocols on Lower Body Power

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    Smith Chad E.

    2014-09-01

    Full Text Available Purpose. Complex training (CT involves the coupling of two exercises ostensibly to enhance the effect of the second exercise. Typically, the first exercise is a strength exercise and the second exercise is a power exercise involving similar muscles. In most cases, CT is designed to enhance power. The purpose of this study was twofold. First, this study was designed to determine if lower body power could be enhanced using complex training protocols. Second, this study investigated whether the inclusion of a power exercise instead of a strength exercise as the first exercise in CT would produce differences in lower body power. Methods. Thirty-six recreationally-trained men and women aged 20 to 29 years attending a college physical education course were randomly assigned to one of three groups: squat and countermovement squat jumps (SSJ, kettlebell swings and countermovement squat jumps (KSJ, and a control (CON. Training involving CT lasted 6 weeks. All participants were pre- and posttested for vertical jump performance in order to assess lower body power. Results. Vertical jump scores improved for all groups (p < 0.01. The results also indicated that there were no statistically significant differences between group scores across time (p = 0.215. The statistical power for this analysis was low (0.312, most likely due to the small sample size. However, the results did reveal a trend suggesting that the training improvements were greater for both the SSJ and KSJ groups compared with the CON (by 171% and 107%, respectively although significance was not reached. Conclusions. Due to the observed trend, a replication of this study with a greater number of participants over a longer period of time is warranted.

  11. Impact of the implementation of electronic guidelines for cardiovascular prevention in primary care: study protocol

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    Eva Comin

    2013-03-01

    Full Text Available Background The electronic medical records software of the Catalan Institute of Health has recently incorporated an electronic version of clinical practice guidelines (e-CPGs. This study aims to assess the impact of the implementation of e-CPGs on the diagnosis, treatment, control and management of hypercholesterolaemia, diabetes mellitus type 2 and hypertension.Methods Eligible study participants are those aged 35–74 years assigned to family practitioners (FPs of the Catalan Institute of Health. Routinely collected data from electronic primary care registries covering 80% of the Catalan population will be analysed using two approaches: (1 a cross-sectional study to describe the characteristics of the sample before e-CPG implementation; (2 a controlled before-and-after study with 1-year follow-up to ascertain the effect of e-CPG implementation. Patients of FPs who regularly use the e-CPGs will constitute the intervention group; the control group will comprise patients assigned to FPs not regularly using the e-CPG. The outcomes are: (1 suspected and confirmed diagnoses, (2 control of clinical variables, (3 requests for tests and (4 proportions of patients with adequate drug prescriptions.Results This protocol should represent a reproducible process to assess the impact of the implementation of e-CPGs. We anticipate reporting results in late 2013.Conclusion This project will assess the effectiveness of e-CPGs to improve clinical decisions and healthcare procedures in the three disorders analysed. The results will shed light on the use of evidence-based medicine to improve clinical practice of FPs.

  12. Promoting fit bodies, healthy eating and physical activity among Indigenous Australian men: a study protocol

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    Ricciardelli Lina A

    2012-01-01

    Full Text Available Abstract Background Overall the physical health of Indigenous men is among the worst in Australia. Research has indicated that modifiable lifestyle factors, such as poor nutrition and physical inactivity, appear to contribute strongly to these poor health conditions. To effectively develop and implement strategies to improve the health of Australia's Indigenous peoples, a greater understanding is needed of how Indigenous men perceive health, and how they view and care for their bodies. Further, a more systematic understanding of how sociocultural factors affect their health attitudes and behaviours is needed. This article presents the study protocol of a community-based investigation into the factors surrounding the health and body image of Indigenous Australian men. Methods and design The study will be conducted in a collaborative manner with Indigenous Australian men using a participatory action research framework. Men will be recruited from three locations around Australia (metropolitan, regional, and rural and interviewed to understand their experiences and perspectives on a number of issues related to health and health behaviour. The information that is collected will be analysed using modified grounded theory and thematic analysis. The results will then be used to develop and implement community events in each location to provide feedback on the findings to the community, promote health enhancing strategies, and determine future action and collaboration. Discussion This study will explore both risk and protective factors that affect the health of Indigenous Australian men. This knowledge will be disseminated to the wider Indigenous community and can be used to inform future health promotion strategies. The expected outcome of this study is therefore an increased understanding of health and health change in Indigenous Australian men, the development of strategies that promote healthy eating and positive patterns of physical activity and, in

  13. Teacher's Perceptions of Sheltered Instruction Observation Protocol for Teaching Young English Language Learners: A Qualitative Case Study

    Science.gov (United States)

    Rodriguez Moux, Shirley

    2010-01-01

    This qualitative case study explored the use of sheltered instruction observation protocol (SIOP) instructional practices to promote the language development and learning of elementary English language learners (ELLs) in an immersion setting in 1st and 2nd grades. The SIOP model was developed for middle school ELLs, and there is scant information…

  14. Celeration of Executive Functioning while Solving the Tower of Hanoi: Two Single Case Studies Using Protocol Analysis

    NARCIS (Netherlands)

    Janssen, G.T.L.; Mey, H.R.A. de; Egger, J.I.M.; Witteman, C.L.M.

    2010-01-01

    The present study was designed to systematically explore individual learning abilities by an in depth analysis of the performances of two single participants on the five disk Tower of Hanoi. Verbal protocols were obtained to provide us with a detailed picture of strategy development and learning. Co

  15. Characterisation of exposure to non-ionising electromagnetic fields in the Spanish INMA birth cohort: Study protocol

    NARCIS (Netherlands)

    M. Gallastegi (Mara); M. Guxens (Mònica ); A. Jiménez-Zabala (Ana); I. Calvente (Irene); M. Fernández (Marta); L. Birks (Laura); B. Struchen (Benjamin); M. Vrijheid (Martine); M. Estarlich (Marisa); M.F. Fernandez (Mariana); M. Torrent (Maties); F. Ballester (Ferran); J.J. Aurrekoetxea (Juan José); J. Ibarluzea (Jesús); D. Guerra (David); J. González (Julián); M. Röösli (Martin); L. Santa-Marina (Loreto)

    2016-01-01

    textabstractBackground: Analysis of the association between exposure to electromagnetic fields of non-ionising radiation (EMF-NIR) and health in children and adolescents is hindered by the limited availability of data, mainly due to the difficulties on the exposure assessment. This study protocol de

  16. False-positive diatom test: a real challenge? A post-mortem study using standardized protocols.

    Science.gov (United States)

    Lunetta, Philippe; Miettinen, Arto; Spilling, Kristian; Sajantila, Antti

    2013-09-01

    The main criticism of the validity of the diatom test for the diagnosis of drowning is based on the potential ante- and post-mortem penetration of diatoms and the finding of diatoms in bodies of non-drowned human beings. However, qualitative and quantitative studies on diatoms in organs of the non-drowned have yielded both conflicting and contradictory results. In the present study, we have analysed under standardised methods the diatom content in several organs of 14 non-drowned human bodies. Overall, only 9 diatoms (6 entire, 3 fragmented) were disclosed in 6 of the 14 non-drowned bodies. Each of these 6 cadavers had only a single "positive" organ. Six diatoms were found in the bone marrow, 2 in the lung, and one in the pleural liquid. No diatoms were recovered from the brain, liver, kidney, or blood samples of any of these 14 bodies. Moreover, in five additional cadavers, whose lungs were injected, prior autopsy, with a 3.5L solution containing a bi-cellulate diatom culture (Thalassiosira baltica, Thalassiosira levanderi) via tracheostomy, a few diatoms appeared in the pleural cavity and in the blood from the left heart chamber, but none in any other internal organs investigated. The results of the presented study demonstrate that the issue of the false-positive diatom test should not be a logical impediment to the performance of the diatom method. However, strict and standardized protocols aimed at avoiding contamination during sample preparation must be used, appropriate separation values set and taxonomic analysis of all diatoms performed. PMID:23701706

  17. Comparative Study of AODV and DSR Routing Protocols for MANET: Performance Analysis

    Directory of Open Access Journals (Sweden)

    Nidhi Goyal

    2013-11-01

    Full Text Available An ad hoc network is an assortment of wireless mobile nodes dynamically forming a transitory network lacking the use of any presented network communications or centralized management. A number of routing protocols like Dynamic Source Routing (DSR, Ad Hoc on-Demand Distance Vector Routing (AODV and Temporally Ordered Routing Algorithm (TORA have been projected. In this work an attempt has been ended to evaluate the performance of two outstanding on demand reactive routing protocols for mobile ad hoc networks: DSR and AODV. Although DSR and AODV share comparable on-demand behavior, the differences in the protocol mechanics can lead to significant performance differentials. The performance differentials are analyzed using varying time, packet delivery ratio, throughput and end-to-end delay. These simulations are carried out using the ns-2 network simulator, which is used to run ad hoc simulations.

  18. Sydney epilepsy incidence study to measure illness consequences: the SESIMIC observational epilepsy study protocol

    Directory of Open Access Journals (Sweden)

    Jan Stephen

    2011-01-01

    Full Text Available Abstract Background Epilepsy affects an estimated 50 million people and accounts for approximately 1% of days lost to ill health globally, making it one of the most common, serious neurological disorders. While there are abundant global data on epilepsy incidence, prevalence and treatment, there is a paucity of Australian incidence data. There is also a general lack of information on the psychosocial impact and socioeconomic consequences of a new diagnosis of epilepsy on an individual, their family, household, and community which are often specific to the health and social system of each country. Methods/Design The Sydney Epilepsy Incidence Study to Measure Illness Consequences (SEISMIC is an Australian population-based epilepsy incidence and outcome study that will recruit every newly diagnosed case of epilepsy in the Sydney South West Area Health Service to an epilepsy register. Multiple and overlapping sources of notification will be used to identify all new cases of epilepsy over a 24 month period in the Eastern Zone of the Sydney South West Area Health Service (SSWAHS and follow up will occur over 12 months. SEISMIC will use the International League Against Epilepsy (ILAE definitions and classifications for epidemiologic studies of epilepsy. The study will examine outcomes including mood, quality of life, employment, education performance, driving status, marital and social problems, medication use, health care usage, costs and stigma. Discussion This study is designed to examine how clinical, psychological factors, socioeconomic circumstances, and healthcare delivery influence the experience of epilepsy for individuals and families allowing better targeting of specific services and informing policy makers and practitioners. In addition, the study will provide the basis for a longitudinal population-based cohort study and potentially inform qualitative sub-studies and randomised controlled trials of intervention strategies. The study has

  19. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    Directory of Open Access Journals (Sweden)

    Clancy Richard

    2011-07-01

    Full Text Available Abstract Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic. Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT; referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide, will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration

  20. Built Environment and Active Transport to School (BEATS) Study: protocol for a cross-sectional study

    OpenAIRE

    Mandic, Sandra; Williams, John; Moore, Antoni; Hopkins, Debbie; Flaherty, Charlotte; Wilson, Gordon; García Bengoechea, Enrique; Spence, John C.

    2016-01-01

    Introduction Active transport to school (ATS) is a convenient way to increase physical activity and undertake an environmentally sustainable travel practice. The Built Environment and Active Transport to School (BEATS) Study examines ATS in adolescents in Dunedin, New Zealand, using ecological models for active transport that account for individual, social, environmental and policy factors. The study objectives are to: (1) understand the reasons behind adolescents and their parents' choice of...

  1. Comparative Study of Hidden Node Problem and Solution Using Different Techniques and Protocols

    CERN Document Server

    Kapadia, Viral V; Jhaveri, Rutvij H

    2010-01-01

    Hidden nodes in a wireless network refer to nodes that are out of range of other nodes or a collection of nodes. We will discuss a few problems introduced by the RTS/CTS mechanism of collision avoidance and focus on the virtual jamming problem, which allows a malicious node to effectively jam a large fragment of a wireless network at minimum expense of power. We have also discussed WiCCP (Wireless Central Coordinated Protocol) which is a protocol booster that also provides good solution to hidden nodes.

  2. Affective factors and strategy use in a distance language context: a pilot study using think-aloud verbal protocols

    OpenAIRE

    Hurd, Stella

    2008-01-01

    This paper reports on a small-scale ethnographic pilot study using think-aloud verbal protocols (TAPs), which was carried out with novice distance learners of French. The study aimed to extend knowledge of the distance language learner experience through allowing learners to talk freely about the positive and negative emotions they were experiencing as they tackled two designated language tasks, and the strategies they used to manage these emotions. The study was prompted by the lack of resea...

  3. Prospective study of Outcomes in Sporadic versus Hereditary breast cancer (POSH: study protocol

    Directory of Open Access Journals (Sweden)

    Ennis Sarah

    2007-08-01

    Full Text Available Abstract Background Young women presenting with breast cancer are more likely to have a genetic predisposition to the disease than breast cancer patients in general. A genetic predisposition is known to increase the risk of new primary breast (and other cancers. It is unclear from the literature whether genetic status should be taken into consideration when planning adjuvant treatment in a young woman presenting with a first primary breast cancer. The primary aim of the POSH study is to establish whether genetic status influences the prognosis of primary breast cancer independently of known prognostic factors. Methods/design The study is a prospective cohort study recruiting 3,000 women aged 40 years or younger at breast cancer diagnosis; the recruiting period covers 1st June 2001 to 31st December 2007. Written informed consent is obtained at study entry. Family history and known epidemiological risk data are collected by questionnaire. Clinical information about diagnosis, treatment and clinical course is collected and blood is stored. Follow up data are collected annually after the first year. An additional recruitment category includes women aged 41 to 50 years who are found to be BRCA1 or BRCA2 gene carriers and were diagnosed with their first breast cancer during the study recruiting period. Discussion Power estimates were based on 10% of the cohort carrying a BRCA1 gene mutation. Preliminary BRCA1 and BRCA2 mutation analysis in a pilot set of study participants confirms we should have 97% power to detect a difference of 10% in event rates between gene carriers and sporadic young onset cases. Most of the recruited patients (>80% receive an anthracycline containing adjuvant chemotherapy regimen making planned analyses more straightforward.

  4. Prospective study of Outcomes in Sporadic versus Hereditary breast cancer (POSH): study protocol

    International Nuclear Information System (INIS)

    Young women presenting with breast cancer are more likely to have a genetic predisposition to the disease than breast cancer patients in general. A genetic predisposition is known to increase the risk of new primary breast (and other) cancers. It is unclear from the literature whether genetic status should be taken into consideration when planning adjuvant treatment in a young woman presenting with a first primary breast cancer. The primary aim of the POSH study is to establish whether genetic status influences the prognosis of primary breast cancer independently of known prognostic factors. The study is a prospective cohort study recruiting 3,000 women aged 40 years or younger at breast cancer diagnosis; the recruiting period covers 1st June 2001 to 31st December 2007. Written informed consent is obtained at study entry. Family history and known epidemiological risk data are collected by questionnaire. Clinical information about diagnosis, treatment and clinical course is collected and blood is stored. Follow up data are collected annually after the first year. An additional recruitment category includes women aged 41 to 50 years who are found to be BRCA1 or BRCA2 gene carriers and were diagnosed with their first breast cancer during the study recruiting period. Power estimates were based on 10% of the cohort carrying a BRCA1 gene mutation. Preliminary BRCA1 and BRCA2 mutation analysis in a pilot set of study participants confirms we should have 97% power to detect a difference of 10% in event rates between gene carriers and sporadic young onset cases. Most of the recruited patients (>80%) receive an anthracycline containing adjuvant chemotherapy regimen making planned analyses more straightforward

  5. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce F

    2011-10-01

    Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial

  6. Built Environment and Active Transport to School (BEATS) Study: protocol for a cross-sectional study

    Science.gov (United States)

    Mandic, Sandra; Williams, John; Moore, Antoni; Hopkins, Debbie; Flaherty, Charlotte; Wilson, Gordon; García Bengoechea, Enrique; Spence, John C

    2016-01-01

    Introduction Active transport to school (ATS) is a convenient way to increase physical activity and undertake an environmentally sustainable travel practice. The Built Environment and Active Transport to School (BEATS) Study examines ATS in adolescents in Dunedin, New Zealand, using ecological models for active transport that account for individual, social, environmental and policy factors. The study objectives are to: (1) understand the reasons behind adolescents and their parents' choice of transport mode to school; (2) examine the interaction between the transport choices, built environment, physical activity and weight status in adolescents; and (3) identify policies that promote or hinder ATS in adolescents. Methods and analysis The study will use a mixed-method approach incorporating both quantitative (surveys, anthropometry, accelerometers, Geographic Information System (GIS) analysis, mapping) and qualitative methods (focus groups, interviews) to gather data from students, parents, teachers and school principals. The core data will include accelerometer-measured physical activity, anthropometry, GIS measures of the built environment and the use of maps indicating route to school (students)/work (parents) and perceived safe/unsafe areas along the route. To provide comprehensive data for understanding how to change the infrastructure to support ATS, the study will also examine complementary variables such as individual, family and social factors, including student and parental perceptions of walking and cycling to school, parental perceptions of different modes of transport to school, perceptions of the neighbourhood environment, route to school (students)/work (parents), perceptions of driving, use of information communication technology, reasons for choosing a particular school and student and parental physical activity habits, screen time and weight status. The study has achieved a 100% school recruitment rate (12 secondary schools). Ethics and

  7. Transitions of Care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK Study: A study of protocols in Greater London

    Directory of Open Access Journals (Sweden)

    Ford Tamsin

    2008-06-01

    Full Text Available Abstract Background Although young people's transition from Child and Adolescent Mental Health Services (CAMHS to Adult Mental Health Services (AMHS in England is a significant health issue for service users, commissioners and providers, there is little evidence available to guide service development. The TRACK study aims to identify factors which facilitate or impede effective transition from CAHMS to AMHS. This paper presents findings from a survey of transition protocols in Greater London. Methods A questionnaire survey (Jan-April 2005 of Greater London CAMHS to identify transition protocols and collect data on team size, structure, transition protocols, population served and referral rates to AMHS. Identified transition protocols were subjected to content analysis. Results Forty two of the 65 teams contacted (65% responded to the survey. Teams varied in type (generic/targeted/in-patient, catchment area (locality-based, wider or national and transition boundaries with AMHS. Estimated annual average number of cases considered suitable for transfer to AMHS, per CAMHS team (mean 12.3, range 0–70, SD 14.5, n = 37 was greater than the annual average number of cases actually accepted by AMHS (mean 8.3, range 0–50, SD 9.5, n = 33. In April 2005, there were 13 active and 2 draft protocols in Greater London. Protocols were largely similar in stated aims and policies, but differed in key procedural details, such as joint working between CAHMS and AMHS and whether protocols were shared at Trust or locality level. While the centrality of service users' involvement in the transition process was identified, no protocol specified how users should be prepared for transition. A major omission from protocols was procedures to ensure continuity of care for patients not accepted by AMHS. Conclusion At least 13 transition protocols were in operation in Greater London in April 2005. Not all protocols meet all requirements set by government policy. Variation in

  8. Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments

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    Patrick DL

    2006-01-01

    Full Text Available Abstract Background Choosing an adequate measurement instrument depends on the proposed use of the instrument, the concept to be measured, the measurement properties (e.g. internal consistency, reproducibility, content and construct validity, responsiveness, and interpretability, the requirements, the burden for subjects, and costs of the available instruments. As far as measurement properties are concerned, there are no sufficiently specific standards for the evaluation of measurement properties of instruments to measure health status, and also no explicit criteria for what constitutes good measurement properties. In this paper we describe the protocol for the COSMIN study, the objective of which is to develop a checklist that contains COnsensus-based Standards for the selection of health Measurement INstruments, including explicit criteria for satisfying these standards. We will focus on evaluative health related patient-reported outcomes (HR-PROs, i.e. patient-reported health measurement instruments used in a longitudinal design as an outcome measure, excluding health care related PROs, such as satisfaction with care or adherence. The COSMIN standards will be made available in the form of an easily applicable checklist. Method An international Delphi study will be performed to reach consensus on which and how measurement properties should be assessed, and on criteria for good measurement properties. Two sources of input will be used for the Delphi study: (1 a systematic review of properties, standards and criteria of measurement properties found in systematic reviews of measurement instruments, and (2 an additional literature search of methodological articles presenting a comprehensive checklist of standards and criteria. The Delphi study will consist of four (written Delphi rounds, with approximately 30 expert panel members with different backgrounds in clinical medicine, biostatistics, psychology, and epidemiology. The final checklist will

  9. Train High Eat Low for Osteoarthritis study (THE LO study: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yareni Guerrero

    2015-10-01

    Discussion: THE LO study will provide the first direct comparison of the long-term benefits of gait retraining, progressive resistance training and a high-protein/low-glycaemic-index energy-restricted diet, separately and in combination, on joint load, radiographic progression, symptoms, and associated co-morbidities in overweight/obese adults with OA of the knee.

  10. The Healthy Primary School of the Future : study protocol of a quasi-experimental study

    NARCIS (Netherlands)

    Willeboordse, M; Jansen, M W; van den Heijkant, S N; Simons, A; Winkens, B; de Groot, R H M; Bartelink, N; Kremers, S P; van Assema, P; Savelberg, H H; de Neubourg, E; Borghans, L; Schils, T; Coppens, K M; Dietvorst, R; Ten Hoopen, R; Coomans, F; Klosse, S; Conjaerts, M H J; Oosterhoff, M; Joore, M A; Ferreira, I; Muris, P; Bosma, H; Toppenberg, H L; van Schayck, C P

    2016-01-01

    BACKGROUND: Unhealthy lifestyles in early childhood are a major global health challenge. These lifestyles often persist from generation to generation and contribute to a vicious cycle of health-related and social problems. This design article presents a study evaluating the effects of two novel heal

  11. Community paediatric respiratory infection surveillance study protocol: a feasibility, prospective inception cohort study

    Science.gov (United States)

    Anderson, Emma C; Ingle, Suzanne Marie; Muir, Peter; Beck, Charles; Finn, Adam; Leeming, John Peter; Cabral, Christie; Kesten, Joanna May; Hay, Alastair D

    2016-01-01

    Introduction Paediatric respiratory tract infections (RTIs) are common reasons for primary care consultations and antibiotic prescribing. Locally relevant syndromic and microbiological surveillance information has the potential to improve the care of children with RTIs by normalising illness (parents) and reducing uncertainty (clinicians). Currently, most RTI studies are conducted at the point of healthcare service consultation, leaving the community burden, microbiology, symptom duration and proportion consulting largely unknown. This study seeks to establish the feasibility of (mainly online) participant recruitment and retention, and the acceptability/comparability of parent versus nurse-collected microbiological sampling, to inform the design of a future surveillance intervention study. Evidence regarding consultation rates and symptom duration is also sought. Methods and analysis A community-based, feasibility prospective inception cohort study, recruiting children aged ≥3 months and rates. Feasibility will be assessed using recruitment and retention rates, data completeness; and acceptability by quantitative survey and qualitative interviews. Symptomatic parent and nurse swab pairs will be compared for microbe isolation. PMID:27580839

  12. Optimal scanning protocols of 64-slice CT angiography in coronary artery stents: An in vitro phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Almutairi, Abdulrahman Marzouq [Discipline of Medical Imaging, Department of Imaging and Applied Physics, Curtin University of Technology, Perth, Western Australia (Australia); Sun Zhonghua [Discipline of Medical Imaging, Department of Imaging and Applied Physics, Curtin University of Technology, Perth, Western Australia (Australia)], E-mail: z.sun@curtin.edu.au; Ng, Curtise [Discipline of Medical Imaging, Department of Imaging and Applied Physics, Curtin University of Technology, Perth, Western Australia (Australia); Al-Safran, Zakariya A.; Al-Mulla, Abeer A.; Al-Jamaan, Abdulaziz I. [Department of Medical Imaging, King Fahad Specialist Hospital, Dammam (Saudi Arabia)

    2010-04-15

    Purpose: The purpose of the study was to investigate the optimal scanning protocol of 64-slice CT angiography for assessment of coronary artery stents based on a phantom study. Materials and methods: Coronary stents with a diameter of 2.5 mm was implanted in thin plastic tubes with an inner diameter of 3.0 mm to simulate a coronary artery. The tubes were filled with iodinated contrast medium diluted to 178 HU, closed at both ends and positioned in a plastic container filled with vegetable oil (-70 to -100 HU). A series of scans were performed with a 64-slice CT scanner with the following protocols: section thickness: 0.67 mm, 1.0 mm, 1.5 mm, 2.0 mm, pitch value: 0.2, 0.3, 0.5 and reconstruction interval of 50% overlap of the section thickness. 2D axial and multiplanar reformatted images were generated to assess the visibility of stent lumen, while virtual intravascular endoscopy (VIE) was reconstructed to evaluate the artery wall and stent surface. Results: Our results showed that a scanning protocol of 1.0 mm slice thickness with a pitch of 0.3 produced acceptable images with best demonstration of the intrastent lumen and stent surface with minimal image noise or artifacts. In contrast, submillimeter scans with 0.67 mm resulted in moderate artifacts which affected visualization of the coronary lumen, in addition to the increased noise. When the section thickness increased to 1.5 mm and 2.0 mm, visualization of the artery wall and stent surface was compromised, although the intrastent lumen was still visible. Conclusion: Our in vitro study suggested that a scanning protocol of 1.0 mm section thickness with pitch of 0.3 is the optimal protocol for evaluation of coronary artery stents as it allows generation of acceptable images with better visualization of stent lumen, stent surface and coronary artery wall.

  13. Optimal scanning protocols of 64-slice CT angiography in coronary artery stents: An in vitro phantom study

    International Nuclear Information System (INIS)

    Purpose: The purpose of the study was to investigate the optimal scanning protocol of 64-slice CT angiography for assessment of coronary artery stents based on a phantom study. Materials and methods: Coronary stents with a diameter of 2.5 mm was implanted in thin plastic tubes with an inner diameter of 3.0 mm to simulate a coronary artery. The tubes were filled with iodinated contrast medium diluted to 178 HU, closed at both ends and positioned in a plastic container filled with vegetable oil (-70 to -100 HU). A series of scans were performed with a 64-slice CT scanner with the following protocols: section thickness: 0.67 mm, 1.0 mm, 1.5 mm, 2.0 mm, pitch value: 0.2, 0.3, 0.5 and reconstruction interval of 50% overlap of the section thickness. 2D axial and multiplanar reformatted images were generated to assess the visibility of stent lumen, while virtual intravascular endoscopy (VIE) was reconstructed to evaluate the artery wall and stent surface. Results: Our results showed that a scanning protocol of 1.0 mm slice thickness with a pitch of 0.3 produced acceptable images with best demonstration of the intrastent lumen and stent surface with minimal image noise or artifacts. In contrast, submillimeter scans with 0.67 mm resulted in moderate artifacts which affected visualization of the coronary lumen, in addition to the increased noise. When the section thickness increased to 1.5 mm and 2.0 mm, visualization of the artery wall and stent surface was compromised, although the intrastent lumen was still visible. Conclusion: Our in vitro study suggested that a scanning protocol of 1.0 mm section thickness with pitch of 0.3 is the optimal protocol for evaluation of coronary artery stents as it allows generation of acceptable images with better visualization of stent lumen, stent surface and coronary artery wall.

  14. Tailoring International Pressure Ulcer Prevention Guidelines for Nigeria: A Knowledge Translation Study Protocol

    Directory of Open Access Journals (Sweden)

    Rose Ekama Ilesanmi

    2015-07-01

    Full Text Available Background: The 2014 International Pressure Ulcer Prevention (PUP Clinical Practice Guidelines (CPG provides the most current evidence based strategies to prevent Pressure Ulcer (PU. The evidence upon which these guidelines have been developed has predominantly been generated from research conducted in developed countries. Some of these guidelines may not be feasible in developing countries due to structural and resource issues; therefore there is a need to adapt these guidelines to the context thus making it culturally acceptable. Aim: To present a protocol detailing the tailoring of international PUPCPG into a care bundle for the Nigerian context. Methods: Guided by the Knowledge to Action (KTA framework, a two phased study will be undertaken. In Phase 1, the Delphi technique with stakeholder leaders will be used to review the current PUPCPG, identifying core strategies that are feasible to be adopted in Nigeria. These core strategies will become components of a PUP care bundle. In Phase 2, key stakeholder interviews will be used to identify the barriers, facilitators and potential implementation strategies to promote uptake of the PUP care bundle. Results: A PUP care bundle, with three to eight components is expected to be developed from Phase 1. Implementation strategies to promote adoption of the PUP care bundle into clinical practice in selected Nigerian hospitals, is expected to result from Phase 2. Engagement of key stakeholders and consumers in the project should promote successful implementation and translate into better patient care. Conclusion: Using KTA, a knowledge translation framework, to guide the implementation of PUPCPG will enhance the likelihood of successful adoption in clinical practice. In implementing a PUP care bundle, developing countries face a number of challenges such as the feasibility of its components and the required resources.

  15. Age and gender leucocytes variances and references values generated using the standardized ONE-Study protocol.

    Science.gov (United States)

    Kverneland, Anders H; Streitz, Mathias; Geissler, Edward; Hutchinson, James; Vogt, Katrin; Boës, David; Niemann, Nadja; Pedersen, Anders Elm; Schlickeiser, Stephan; Sawitzki, Birgit

    2016-06-01

    Flow cytometry is now accepted as an ideal technology to reveal changes in immune cell composition and function. However, it is also an error-prone and variable technology, which makes it difficult to reproduce findings across laboratories. We have recently developed a strategy to standardize whole blood flow cytometry. The performance of our protocols was challenged here by profiling samples from healthy volunteers to reveal age- and gender-dependent differences and to establish a standardized reference cohort for use in clinical trials. Whole blood samples from two different cohorts were analyzed (first cohort: n = 52, second cohort: n = 46, both 20-84 years with equal gender distribution). The second cohort was run as a validation cohort by a different operator. The "ONE Study" panels were applied to analyze expression of >30 different surface markers to enumerate proportional and absolute numbers of >50 leucocyte subsets. Indeed, analysis of the first cohort revealed significant age-dependent changes in subsets e.g. increased activated and differentiated CD4(+) and CD8(+) T cell subsets, acquisition of a memory phenotype for Tregs as well as decreased MDC2 and Marginal Zone B cells. Males and females showed different dynamics in age-dependent T cell activation and differentiation, indicating faster immunosenescence in males. Importantly, although both cohorts consisted of a small sample size, our standardized approach enabled validation of age-dependent changes with the second cohort. Thus, we have proven the utility of our strategy and generated reproducible reference ranges accounting for age- and gender-dependent differences, which are crucial for a better patient monitoring and individualized therapy. © 2016 International Society for Advancement of Cytometry. PMID:27144459

  16. SALGOT - Stroke Arm Longitudinal study at the University of Gothenburg, prospective cohort study protocol

    Directory of Open Access Journals (Sweden)

    Lundgren-Nilsson Åsa

    2011-05-01

    Full Text Available Abstract Background Recovery patterns of upper extremity motor function have been described in several longitudinal studies, but most of these studies have had selected samples, short follow up times or insufficient outcomes on motor function. The general understanding is that improvements in upper extremity occur mainly during the first month after the stroke incident and little if any, significant recovery can be gained after 3-6 months. The purpose of this study is to describe the recovery of upper extremity function longitudinally in a non-selected sample initially admitted to a stroke unit with first ever stroke, living in Gothenburg urban area. Methods/Design A sample of 120 participants with a first-ever stroke and impaired upper extremity function will be consecutively included from an acute stroke unit and followed longitudinally for one year. Assessments are performed at eight occasions: at day 3 and 10, week 3, 4 and 6, month 3, 6 and 12 after onset of stroke. The primary clinical outcome measures are Action Research Arm Test and Fugl-Meyer Assessment for Upper Extremity. As additional measures, two new computer based objective methods with kinematic analysis of arm movements are used. The ABILHAND questionnaire of manual ability, Stroke Impact Scale, grip strength, spasticity, pain, passive range of motion and cognitive function will be assessed as well. At one year follow up, two patient reported outcomes, Impact on Participation and Autonomy and EuroQol Quality of Life Scale, will be added to cover the status of participation and aspects of health related quality of life. Discussion This study comprises a non-selected population with first ever stroke and impaired arm function. Measurements are performed both using traditional clinical assessments as well as computer based measurement systems providing objective kinematic data. The ICF classification of functioning, disability and health is used as framework for the selection of

  17. Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study

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    Peter Fairbairn

    2015-01-01

    Full Text Available Purpose. To present a novel protocol for alveolar bone regeneration in parallel to early implant placement. Methods. 497 patients in need of extraction and early implant placement with simultaneous bone augmentation were treated in a period of 10 years. In all patients the same specific method was followed and grafting was performed utilizing in situ hardening fully resorbable alloplastic grafting materials consisting of β-tricalcium phosphate and calcium sulfate. The protocol involved atraumatic extraction, implant placement after 4 weeks with simultaneous bone augmentation, and loading of the implant 12 weeks after placement and grafting. Follow-up periods ranged from 6 months to 10 years (mean of 4 years. Results. A total of 601 postextraction sites were rehabilitated in 497 patients utilizing the novel protocol. Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%. Conclusions. This standardized protocol allows successful long-term functional results regarding alveolar bone regeneration and implant rehabilitation. The concept of placing the implant 4 weeks after extraction, augmenting the bone around the implant utilizing fully resorbable, biomechanically stable, alloplastic materials, and loading the implant at 12 weeks seems to offer advantages when compared with traditional treatment modalities.

  18. Application of the Putting Women First protocol in a study on violence against immigrant women in Spain.

    Science.gov (United States)

    Torrubiano-Domínguez, Jordi; Vives-Cases, Carmen

    2013-01-01

    In this paper, we describe our experience of using the Putting Women First protocol in the design and implementation of a cross-sectional study on violence against women (VAW) among 1607 immigrant women from Morocco, Ecuador and Romania living in Spain in 2011. The Putting Women First protocol is an ethical guideline for VAW research, which includes recommendations to ensure the safety of the women involved in studies on this subject. The response rate in this study was 59.3%. The prevalence of VAW cases last year was 11.7%, of which 15.6% corresponded to Ecuadorian women, 10.9% to Moroccan women and 8.6% to Romanian women. We consider that the most important goal for future research is the use of VAW scales validated in different languages, which would help to overcome the language barriers encountered in this study.

  19. The study to understand mortality and morbidity in COPD (SUMMIT) study protocol

    DEFF Research Database (Denmark)

    Vestbo, Jørgen; Anderson, Julie; Brook, Robert D;

    2013-01-01

    medications on CVD in patients with both diseases.The "Study to Understand Mortality and MorbidITy in COPD" (SUMMIT) aims at determining the impact of Fluticasone Furoate/Vilanterol combination (FF/VI), and the individual components on the survival of patients with moderate COPD and either a history of CVD...... or at increased risk for CVD.SUMMIT is a multi-center, randomised, double-blind, parallel-group, placebo-controlled trial of 16,000 patients with moderate COPD randomly assigned to once daily treatment with FF/VI (100/25 ;mcg), Fluticasone Furoate (100 ;mcg), Vilanterol (25 ;mcg) or matched placebo; mortality...

  20. The Study of Environment on Aboriginal Resilience and Child Health (SEARCH: study protocol

    Directory of Open Access Journals (Sweden)

    2010-05-01

    Full Text Available Abstract Background Aboriginal Australians have a life expectancy more than ten years less than that of non-Aboriginal Australians, reflecting their disproportionate burden of both communicable and non-communicable disease throughout the lifespan. Little is known about the health and health trajectories of Aboriginal children and, although the majority of Aboriginal people live in urban areas, data are particularly sparse in relation to children living in urban areas. Methods/Design The Study of Environment on Aboriginal Resilience and Child Health (SEARCH is a cohort study of Aboriginal children aged 0-17 years, from urban and large regional centers in New South Wales, Australia. SEARCH focuses on Aboriginal community identified health priorities of: injury; otitis media; vaccine-preventable conditions; mental health problems; developmental delay; obesity; and risk factors for chronic disease. Parents/caregivers and their children are invited to participate in SEARCH at the time of presentation to one of the four participating Aboriginal Community Controlled Health Organisations at Mount Druitt, Campbelltown, Wagga Wagga and Newcastle. Questionnaire data are obtained from parents/caregivers and children, along with signed permission for follow-up through repeat data collection and data linkage. All children have their height, weight, waist circumference and blood pressure measured and complete audiometry, otoscopy/pneumatic otoscopy and tympanometry. Children aged 1-7 years have speech and language assessed and their parents/caregivers complete the Parental Evaluation of Developmental Status. The Study aims to recruit 1700 children by the end of 2010 and to secure resources for long term follow up. From November 2008 to March 2010, 1010 children had joined the study. From those 446 children with complete data entry, participating children ranged in age from 2 weeks to 17 years old, with 144 aged 0-3, 147 aged 4-7, 75 aged 8-10 and 79 aged 11

  1. Assessing function in patients undergoing joint replacement: a study protocol for a cohort study

    Directory of Open Access Journals (Sweden)

    Wylde Vikki

    2012-11-01

    Full Text Available Abstract Background Joint replacement is an effective intervention for people with advanced arthritis, although there is an important minority of patients who do not improve post-operatively. There is a need for robust evidence on outcomes after surgery, but there are a number of measures that assess function after joint replacement, many of which lack any clear theoretical basis. The World Health Organisation has introduced the International Classification of Functioning, Disability and Health (ICF, which divides function into three separate domains: Impairment, activity limitations and participation restrictions. The aim of this study is to compare the properties and responsiveness of a selection of commonly used outcome tools that assess function, examine how well they relate to the ICF concepts, and to explore the changes in the measures over time. Methods/design Two hundred and sixty three patients listed for lower limb joint replacement at an elective orthopaedic centre have been recruited into this study. Participants attend the hospital for a research appointment prior to surgery and then at 3-months and 1-year after surgery. At each assessment time, function is assessed using a range of measures. Self-report function is assessed using the WOMAC, Aberdeen Impairment, Activity Limitation and Participation Restriction Measure, SF-12 and Measure Yourself Medical Outcome Profile 2. Clinician-administered measures of function include the American Knee Society Score for knee patients and the Harris Hip Score for hip patients. Performance tests include the timed 20-metre walk, timed get up and go, sit-to-stand-to-sit, step tests and single stance balance test. During the performance tests, participants wear an inertial sensor and data from motion analysis are collected. Statistical analysis will include exploring the relationship between measures describing the same ICF concepts, assessing responsiveness, and studying changes in measures over

  2. Review of recent studies and issues regarding the P300-based complex trial protocol for detection of concealed information.

    Science.gov (United States)

    Rosenfeld, J Peter; Hu, Xiaoqing; Labkovsky, Elena; Meixner, John; Winograd, Michael R

    2013-11-01

    In this review, the evolution of new P300-based protocols for detection of concealed information is summarized. The P300-based complex trial protocol (CTP) is described as one such countermeasure (CM)-resistant protocol. Recent lapses in diagnostic accuracy (from 90% to 75%) with CTPs applied to mock crime protocols are summarized, as well as recent enhancements to the CTP which have restored accuracy. These enhancements include 1) use of performance feedback during testing, 2) use of other ERP components such as N200 in diagnosis, 3) use of auxiliary tests, including the autobiographical implicit association test, as leading to restored diagnostic accuracy, and 4) a study of the mechanisms underlying CMs. A novel, doubly efficient version of the CTP involving presentation of two probes in one trial is described as a new way to improve accuracy to levels above 90% in mock crime situations. Finally, a thorough analysis of the legal issues surrounding use of the CTP in U.S. is given. PMID:24012907

  3. Postoperative Delirium after elective and emergency surgery: analysis and checking of risk factors. A study protocol

    Directory of Open Access Journals (Sweden)

    Gagliardi Stefano

    2005-05-01

    Scale (GCS, Cognitive state (SPMSQ, Functional state (ADL and IADL, Psychological Distress (HADS, Cumulative Illness Rating Scale (CIRS, Hypotension (classified in: light; moderate and severe and duration, Blood loss (classified in: 2 lt, Blood transfusions ( 2 lt, Quantity of red cells and plasma transfusions, Visual VAS / SVS (timing: I-II-III post-operative day, Red cells and Plasma transfusions, Blood count evaluation and Saturation (O2%, Postoperative analgesia (Emilia-Romagna protocol, Presence of malignant tumoral disease, APACHE Score II. Moreover the presence of some relevant genetic polymorphisms will be studied in different genes such as IL-6, IL-10, TNF-alpha, and IL-1 cluster.

  4. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Graeme B

    2012-09-01

    delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability. Discussion The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention. Trial Registration Current Controlled Trials ISRCTN43218782

  5. Characterisation of exposure to non-ionising electromagnetic fields in the Spanish INMA birth cohort: study protocol

    OpenAIRE

    Gallastegi, Mara; Guxens, Mònica; Jiménez-Zabala, Ana; Calvente, Irene; Fernández, Marta; Birks, Laura; Struchen, Benjamin; Vrijheid, Martine; Estarlich, Marisa; Fernandez, Mariana; Torrent, Maties; Ballester, Ferran; Aurrekoetxea, Juan José; Ibarluzea, Jesús; Guerra, David

    2016-01-01

    textabstractBackground: Analysis of the association between exposure to electromagnetic fields of non-ionising radiation (EMF-NIR) and health in children and adolescents is hindered by the limited availability of data, mainly due to the difficulties on the exposure assessment. This study protocol describes the methodologies used for characterising exposure of children to EMF-NIR in the INMA (INfancia y Medio Ambiente- Environment and Childhood) Project, a prospective cohort study. Methods/Des...

  6. Nucleic Acid Research Group 2013–2014 Study: Evaluating Library Synthesis Protocols for Sub-Nanogram ChIPSeq samples

    OpenAIRE

    Carmical, J. Russ; Lytle, Christian H; Nadella, Vijayanand; Beckloff, Nicholas; Perera, Anoja; Tighe, Scott; Chittur, Sridar V.; Herbert, Zach; Auer, Herbert

    2014-01-01

    Chromatin immunoprecipitation followed by sequencing the precipitated DNA (ChIP-Seq) is the state-of-the-art method to study protein-DNA interactions. ChIP-Seq allows identification of binding sites of proteins across the entire genome in an unbiased manner. One of the major limitations of currently available ChIP-Seq protocols is the necessity to isolate sufficient amounts of immune precipitated DNA for subsequent sequencing. The NARG 2013/14 study evaluated library preparation alternatives ...

  7. Individual and occupational risk factors for knee osteoarthritis – Study protocol of a case control study

    Directory of Open Access Journals (Sweden)

    Bouillon Bertil

    2008-02-01

    Full Text Available Abstract Background Knee osteoarthritis (OA is one of the frequent and functionally impairing disorders of the musculoskeletal system. In the literature, a number of occupational risk factors are discussed as being related to the development and progress of knee joint diseases, e.g. working in kneeling or squatting posture, lifting and carrying of heavy weights. The importance of the single risk factors and the possibility of prevention are currently under discussion. Besides the occupational factors, a number of individual risk factors are important, too. The distinction between work-related factors and individual factors is crucial in assessing the risk and in deriving preventive measures in occupational health. In existing studies, the occupational stress is determined mainly by surveys in employees and/or by making assumptions about individual occupations. Direct evaluation of occupational exposure has been performed only exceptionally. The aim of the research project ArGon is the assessment of different occupational factors in relation to individual factors (e.g. constitutional factors, leisure time activities, sports, which might influence the development and/or progression of knee (OA. The project is designed as a case control study. Methods/Design To raise valid data about the physical stress associated with occupational and leisure time activities, patients with and without knee OA are questioned by means of a standardised questionnaire and an interview. The required sample size was estimated to 800 cases and an equal number of controls. The degree and localisation of the knee cartilage or joint damages in the cases are documented on the basis of radiological, arthroscopic and/or operative findings in a patient record. Furthermore, occupational exposure is analysed at selected workplaces. To evaluate the answers provided in the questionnaire, work analysis is performed. Discussion In this research project, specific information on the

  8. Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Wang Kangjun

    2011-06-01

    Full Text Available Abstract Background There are a variety of treatment options for Bell's palsy. Evidence from randomized controlled trials indicates corticosteroids can be used as a proven therapy for Bell's palsy. Acupuncture is one of the most commonly used methods to treat Bell's palsy in China. Recent studies suggest that staging treatment is more suitable for Bell's palsy, according to different path-stages of this disease. The aim of this study is to compare the effects of prednisolone and staging acupuncture in the recovery of the affected facial nerve, and to verify whether prednisolone in combination with staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large number of patients. Methods/Design In this article, we report the design and protocol of a large sample multi-center randomized controlled trial to treat Bell's palsy with prednisolone and/or acupuncture. In total, 1200 patients aged 18 to 75 years within 72 h of onset of acute, unilateral, peripheral facial palsy will be assessed. There are six treatment groups, with four treated according to different path-stages and two not. These patients are randomly assigned to be in one of the following six treatment groups, i.e. 1 placebo prednisolone group, 2 prednisolone group, 3 placebo prednisolone plus acute stage acupuncture group, 4 prednisolone plus acute stage acupuncture group, 5 placebo prednisolone plus resting stage acupuncture group, 6 prednisolone plus resting stage acupuncture group. The primary outcome is the time to complete recovery of facial function, assessed by Sunnybrook system and House-Brackmann scale. The secondary outcomes include the incidence of ipsilateral pain in the early stage of palsy (and the duration of this pain, the proportion of patients with severe pain, the occurrence of synkinesis, facial spasm or contracture, and the severity of residual facial symptoms during the study period. Discussion The result of this trial will assess the

  9. Development of a Protocol for Studying Premature Onset of Fear as a Feature of Pathological Fear: The Effects of Conditional Stimulus Duration and Counting Behavior

    NARCIS (Netherlands)

    Y. Boddez; K. Takano; J. Gijbels; F. Baeyens; T. Beckers

    2015-01-01

    We propose that the premature onset of fear responding is a potentially important feature of pathological fear. A behavioral protocol to study the temporal regulation of fear in humans is, however, lacking. The present study aims at developing such a protocol for healthy individuals. To this end, we

  10. The randomized shortened dental arch study (RaSDA: design and protocol

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    Kern Matthias

    2010-02-01

    Full Text Available Abstract Background Various treatment options for the prosthetic treatment of jaws where all molars are lost are under discussion. Besides the placement of implants, two main treatment types can be distinguished: replacement of the missing molars with removable dental prostheses and non-replacement of the molars, i.e. preservation of the shortened dental arch. Evidence is lacking regarding the long-term outcome and the clinical performance of these approaches. High treatment costs and the long time required for the treatment impede respective clinical trials. Methods/design This 14-center randomized controlled investigator-initiated trial is ongoing. Last patient out will be in 2010. Patients over 35 years of age with all molars missing in one jaw and with at least both canines and one premolar left on each side were eligible. One group received a treatment with removable dental prostheses for molar replacement (treatment A. The other group received a treatment limited to the replacement of all missing anterior and premolar teeth using fixed bridges (treatment B. A pilot trial with 32 patients was carried out. Two hundred and fifteen patients were enrolled in the main trial where 109 patients were randomized for treatment A and 106 for treatment B. The primary outcome measure is further tooth loss during the 5-year follow-up. The secondary outcome measures encompassed clinical, technical and subjective variables. The study is funded by the Deutsche Forschungsgemeinschaft (German Research Foundation, DFG WA 831/2-1, 2-2, 2-3, 2-4, 2-5. Discussion The particular value of this trial is the adaptation of common design components to the very specific features of complex dental prosthetic treatments. The pilot trial proved to be indispensable because it led to a number of adjustments in the study protocol that considerably improved the practicability. The expected results are of high clinical relevance and will show the efficacy of two common

  11. Computational Protocol for Modeling Thermochromic Molecular Crystals: Salicylidene Aniline As a Case Study.

    Science.gov (United States)

    Presti, Davide; Labat, Fréderic; Pedone, Alfonso; Frisch, Michael J; Hratchian, Hrant P; Ciofini, Ilaria; Menziani, Maria Cristina; Adamo, Carlo

    2014-12-01

    A computational protocol that combines periodic and QM/QM' calculations has been applied to investigate the structural (geometrical and electronic) and photophysical absorption properties of the salicylidene aniline (SA) thermochromic molecular crystal. The protocol consists of three different steps, namely (i) the description of the molecular crystal using a periodic approach taking into account dispersion interactions, (ii) the identification of reliable finite models (clusters), and (iii) the calculation of vertical transition energies including environmental effects through the use of an electronic embedding model (QM/QM' ONIOM approach). The encouraging results obtained in this work for the β polymorph of SA, both in terms of accuracy and computational cost, open the way to the simulation and the prediction of the photophysical behavior of other molecular crystals, especially those much less well characterized experimentally. PMID:26583240

  12. A Tribolium castaneum whole-embryo culture protocol for studying the molecular mechanisms and morphogenetic movements involved in insect development.

    Science.gov (United States)

    Macaya, Constanza C; Saavedra, Patricio E; Cepeda, Rodrigo E; Nuñez, Viviana A; Sarrazin, Andres F

    2016-01-01

    The development of the red flour beetle Tribolium castaneum is more representative of arthropods than the evolutionarily derived fly, Drosophila melanogaster. Thus, Tribolium is becoming an emerging organism model for studying the evolution of the mechanisms that control embryonic development in arthropods. In this regard, diverse genetic and molecular tools are currently available for Tribolium, as well as imaging and embryonic techniques. Recently, we developed a method for culturing embryos in order to study specific stages during Tribolium development. In this report, we present a detailed and "easy-to-follow" protocol for embryo handling and dissection, extending the use of whole-embryo culture to functional analysis by performing in vivo pharmacological manipulations. This experimental accessibility allowed us to study the relevance of microtubules in axis elongation, using nocodazole and taxol drugs to interfere with microtubule networks, followed by length measurement analysis. Additionally, we demonstrated that embryo handling had no effect on the development of Tribolium embryos, and we checked viability after dissection and bisection and during incubation using propidium iodide. The embryo culture protocol we describe here can be applied to study diverse developmental processes in Tribolium. We expect that this protocol can be adapted and applied to other arthropods.

  13. Assessing change in patient-reported quality of life after elective surgery: protocol for an observational comparison study

    Science.gov (United States)

    Kronzer, Vanessa L.; Jerry, Michelle R.; Avidan, Michael S.

    2016-01-01

    Despite their widespread use, the two main methods of assessing quality of life after surgery have never been directly compared. To support patient decision-making and study design, we aim to compare these two methods. The first of these methods is to assess quality of life before surgery and again after surgery using the same validated scale. The second is simply to ask patients whether or not they think their post-operative quality of life is better, worse, or the same. Our primary objective is to assess agreement between the two measures. Secondary objectives are to calculate the minimum clinically important difference (MCID) and to describe the variation across surgical specialties. To accomplish these aims, we will administer surveys to patients undergoing elective surgery, both before surgery and again 30 days after surgery. This protocol follows detailed guidelines for observational study protocols.

  14. Weight-loss intervention using implementation intentions and mental imagery: a randomised control trial study protocol

    OpenAIRE

    Hattar, Anne; Hagger, Martin S.; Pal, Sebely

    2015-01-01

    Background Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of go...

  15. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

    OpenAIRE

    Ubbink Dirk T; Gerbens Louise AA; Brölmann Fleur E; Eskes Anne M; Vermeulen Hester

    2011-01-01

    Abstract Background Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds. Methods A 14-center, six-armed randomi...

  16. Comparative Study of MAC Layer Protocols in Wireless Sensor Networks: A Survey

    OpenAIRE

    Lanjewar, Rahul R; D.S.Adane

    2014-01-01

    Wireless Sensor Networks (WSN) is the collection of many small size low cost, battery operated sensor nodes distributed over the targeted region to collect the information of interest. We can say these networks can be a fruitful solution for many applications such as target tracking, intrusion detection etc. Whenever we are talking about MAC layer protocols we need to give stress on energy efficiency factor.

  17. A Comparative Study On The Action Potential Simulation (APS Therapy And The Routine Physiotherapy Protocol In Knee Osteoarthritisin Elderly People

    Directory of Open Access Journals (Sweden)

    Abbas Rahimi

    2012-04-01

    Full Text Available Background and Aim: Knee osteoarthritis is the most common cause for which the elderly people refere to physiotherapy outpatient clinics. This study aimed to investigate the effects of the Action Potential Stimulation (APS Therapy and the routine physiotherapy (PT protocol on relieving pain and swelling as well as the duration of the relief period in patients with knee osteoarthritis. Materials and Methods: 69 patients (62 females & 7 males with knee osteoarthritis were recruited in this study. The subjects were divided into two groups including APS Therapy (n=37, mean age: 55±13 years old and the routine PT protocol (n=32, mean age: 61±14 years old groups. A 10-session treatment period was carried out for each group; and their pain and swelling were measured at the first, fifth and tenth sessions and also one-month after the last session (follow up. The swelling was measured using measuring the circumference of the knee on the patella, 5 Cm above and 5 Cm below the patella. The routine PT protocol consisted of hot pack, ultrasound, TENS and exercise; and the APS therapy protocol included hot pack, APS Therapy and the same exercise. During the follow up, 50 out of 61 subjects were called on the phone and any pain changes were recorded.Results: In terms of swelling, the results showed significant reduction just on the patella only in the APS Therapy group (P<0.05. Visual Analogue Pain Scale (VAPS indicated a significant pain reduction in both groups. However, the APS Therapy group showed significantly pain reduction at the end of sessions five, ten and the follow up session (P<0.05. It was also revealed that while routine PT subjects showed no significant pain changes between the tenth and the follow up session, a gradual pain reduction was seen in the APS therapy group during this period (P<0.05. A gradual dosage reduction was recorded only in the APS therapy group, indicating a slight correlation with pain reduction (r=0.4.Conclusion: The

  18. Gender-specific influence of health behaviors on academic performance in Spanish adolescents: the AFINOS study Rol del género en la influencia de las conductas saludables sobre el rendimiento académico en adolescentes españoles: el estudio AFINOS

    Directory of Open Access Journals (Sweden)

    D. Martínez-Gómez

    2012-06-01

    Full Text Available Introduction: New paradigms based on the multifactorial etiology of chronic diseases and behavioral outcomes suggest that a combination of health behaviors may have more impact on the outcome of interest than any single factor. Objective: To examine the independent and combined influence of four health behaviors on school performance in Spanish adolescents. Methods: A total of 1825 Spanish adolescents reported their grades in Language and Literature (LL and Math. Body mass index, family structure and school-related factors (attitude to school, need to repeat > 1-yr and absenteeism were self-reported. Adolescents were dichotomized as healthy or unhealthy based on meeting or not meeting lifestyle recommendations on physical activity, TV viewing, sleep and fruit intake. Each adolescent was also scored according to the number of healthy recommendations fulfilled. Results: In boys, there were no associations between health behaviors and academic performance. Good academic performance in girls was associated with physical activity (P Introducción: Los nuevos paradigmas basados en la etiología multifactorial de las enfermedades crónicas y los resultados en el comportamiento sugieren que la combinación de comportamientos saludables puede tener un impacto más positivo en algún resultado de interés que cualquier otro factor aislado. Objetivo: explorar la influencia independiente y combinada de cuatro comportamientos saludables sobre el rendimiento escolar de adolescentes españoles. Métodos: Un total de 1.825 adolescentes españoles proporcionaron sus notas en lengua y literatura (LL y matemáticas. El índice de masa corporal, la estructura de la familia y factores relacionados con la escuela (actitud hacia el colegio, necesidad de repetir más de un año y absentismo fueron autoinformados. Se dividió a los adolescentes en saludables y no saludables en función de si cumplían o no unas recomendaciones de estilo de vida relativas a la práctica de actividad física, tiempo viendo la TV, sueño e ingesta de fruta. También se valoró a cada adolescente en función de número de recomendaciones saludables que cumplían. Resultados: En los chicos, no hubo asociaciones entre los comportamientos saludables y el rendimiento académico. El buen rendimiento académico de las chicas se asoció con la actividad física (P < 0,05 y el consumo de fruta (P < 0,05. Además, las chicas que cumplían 3-4 recomendaciones de comportamientos saludables tuvieron una mayor probabilidad de aprobar LL (OR = 3,18, P < 0,001, matemáticas (OR = 1,75, P = 0,028 o LL+Mate-máticas (OR = 2,32, P = 0,001 en comparación con aquellas con puntuaciones de 0-1. Se ajustaron todos los análisis por peso, contexto familiar y diferentes factores relacionados con la escuela. Conclusiones: una combinación de comportamientos saludables podría tener una influencia positiva en el rendimiento académico en las chicas adolescentes.

  19. Study protocol: Evaluating the impact of a rural Australian primary health care service on rural health

    Directory of Open Access Journals (Sweden)

    Buykx Penny

    2011-03-01

    Full Text Available Abstract Background Rural communities throughout Australia are experiencing demographic ageing, increasing burden of chronic diseases, and de-population. Many are struggling to maintain viable health care services due to lack of infrastructure and workforce shortages. Hence, they face significant health disadvantages compared with urban regions. Primary health care yields the best health outcomes in situations characterised by limited resources. However, few rigorous longitudinal evaluations have been conducted to systematise them; assess their transferability; or assess sustainability amidst dynamic health policy environments. This paper describes the study protocol of a comprehensive longitudinal evaluation of a successful primary health care service in a small rural Australian community to assess its performance, sustainability, and responsiveness to changing community needs and health system requirements. Methods/Design The evaluation framework aims to examine the health service over a six-year period in terms of: (a Structural domains (health service performance; sustainability; and quality of care; (b Process domains (health service utilisation and satisfaction; and (c Outcome domains (health behaviours, health outcomes and community viability. Significant international research guided the development of unambiguous reliable indicators for each domain that can be routinely and unobtrusively collected. Data are to be collected and analysed for trends from a range of sources: audits, community surveys, interviews and focus group discussions. Discussion This iterative evaluation framework and methodology aims to ensure the ongoing monitoring of service activity and health outcomes that allows researchers, providers and administrators to assess the extent to which health service objectives are met; the factors that helped or hindered achievements; what worked or did not work well and why; what aspects of the service could be improved and how

  20. Enhancing the early home learning environment through a brief group parenting intervention: study protocol for a cluster randomised controlled trial

    OpenAIRE

    Nicholson, Jan M.; Cann, Warren; Matthews, Jan; Berthelsen, Donna; Obioha C Ukoumunne; Trajanovska, Misel; Bennetts, Shannon K.; Hillgrove, Tessa; Hamilton, Victoria; Westrupp, Elizabeth; Hackworth, Naomi J

    2016-01-01

    Background The quality of the home learning environment has a significant influence on children’s language and communication skills during the early years with children from disadvantaged families disproportionately affected. This paper describes the protocol and participant baseline characteristics of a community-based effectiveness study. It evaluates the effects of ‘smalltalk’, a brief group parenting intervention (with or without home coaching) on the quality of the early childhood home l...

  1. The Dutch ‘Focus on Strength’ intervention study protocol: programme design and production, implementation and evaluation plan

    OpenAIRE

    Ten Hoor, G. A.; Kok, G.; Rutten, G.M.; Ruiter, R. A. C.; Kremers, S. P. J.; Schols, A. M. J. W.; Plasqui, G.

    2016-01-01

    Background Overweight youngsters are better in absolute strength exercises than their normal-weight counterparts; a physiological phenomenon with promising psychological impact. In this paper we describe the study protocol of the Dutch, school-based program ‘Focus on Strength’ that aims to improve body composition of 11–13 year old students, and with that to ultimately improve their quality of life. Methods The development of this intervention is based on the Intervention Mapping (IM) protoco...

  2. Using the intervention mapping protocol to reduce European preschoolers' sedentary behavior, an application to the ToyBox-Study

    OpenAIRE

    De Decker, Ellen; De Craemer, Marieke; De Bourdeaudhuij, Ilse; Verbestel, Vera; Duvinage, Kristin; Iotova, Violeta; Grammatikaki, Evangelia; Wildgruber, Andreas; Mouratidou, Theodora; Manios, Yannis; Cardon, Greet

    2014-01-01

    Background: High levels of sedentary behavior are often measured in preschoolers, but only a few interventions have been developed to counteract this. Furthermore, detailed descriptions of interventions in preschoolers targeting different forms of sedentary behavior could not be located in the literature. The aim of the present paper was to describe the different steps of the Intervention Mapping Protocol used towards the development of an intervention component of the ToyBox-study focusing o...

  3. Clean Development Mechanism” projects in the developing countries within the Kyoto protocol: problem analysis of a case study in Morocco

    OpenAIRE

    Gaglioppa P

    2009-01-01

    An internship period spent in the north of Morocco kingdom (Tetouan) gave a contribute to the organization activity in promoting sustainable development in the rural areas under the Kyoto Protocol. The multitasking project will increase biodiversity planting trees for wood, forage and fruits productions. The paper show a first step study to evaluate the possibility to reach an agreement with the propriety and the manager of these areas in a multifunctional reforestation project. The eligible ...

  4. Efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of depression: study protocol for a randomized controlled trial

    OpenAIRE

    Wang, Huaning; Xue, Yunyun; Chen, Yunchun; Zhang, Ruiguo; Wang, Huaihai; Zhang, Yahong; Gan, Jingli; Zhang, Liyi; Tan, Qingrong

    2013-01-01

    Background Depression is a chronic illness that generally requires lifelong therapy. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique with few side effects that has been reported to be useful in the treatment of depression. However, no studies to date have evaluated in a randomized controlled trial (RCT) the efficacy of rTMS for maintenance treatment of depression. Methods/design In this article, we report the design and protocol of a randomized, single-blind, pl...

  5. SCISSOR—Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol

    Science.gov (United States)

    Kopp, Marcel A; Liebscher, Thomas; Watzlawick, Ralf; Martus, Peter; Laufer, Stefan; Blex, Christian; Schindler, Ralf; Jungehulsing, Gerhard J; Knüppel, Sven; Kreutzträger, Martin; Ekkernkamp, Axel; Dirnagl, Ulrich; Strittmatter, Stephen M; Niedeggen, Andreas; Schwab, Jan M

    2016-01-01

    Introduction The approved analgesic and anti-inflammatory drugs ibuprofen and indometacin block the small GTPase RhoA, a key enzyme that impedes axonal sprouting after axonal damage. Inhibition of the Rho pathway in a central nervous system-effective manner requires higher dosages compared with orthodox cyclooxygenase-blocking effects. Preclinical studies on spinal cord injury (SCI) imply improved motor recovery after ibuprofen/indometacin-mediated Rho inhibition. This has been reassessed by a meta-analysis of the underlying experimental evidence, which indicates an overall effect size of 20.2% regarding motor outcome achieved after ibuprofen/indometacin treatment compared with vehicle controls. In addition, ibuprofen/indometacin may also limit sickness behaviour, non-neurogenic systemic inflammatory response syndrome (SIRS), neuropathic pain and heterotopic ossifications after SCI. Consequently, ‘small molecule’-mediated Rho inhibition after acute SCI warrants clinical investigation. Methods and analysis Protocol of an investigator-initiated clinical open-label pilot trial on high-dose ibuprofen treatment after acute traumatic, motor-complete SCI. A sample of n=12 patients will be enrolled in two cohorts treated with 2400 mg/day ibuprofen for 4 or 12 weeks, respectively. The primary safety end point is an occurrence of serious adverse events, primarily gastroduodenal bleedings. Secondary end points are pharmacokinetics, feasibility and preliminary effects on neurological recovery, neuropathic pain and heterotopic ossifications. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. Additional analyses will be mainly descriptive and casuistic. Ethics and dissemination The clinical trial protocol was approved by the responsible German state Ethics Board, and the Federal Institute for Drugs and Medical Devices. The study complies with the Declaration of Helsinki, the principles of Good Clinical Practice and all further

  6. A simple protocol for the extraction and sequence analysis of DNA from study skin of museum collections

    Directory of Open Access Journals (Sweden)

    Nadia de Moraes-Barros

    2007-01-01

    Full Text Available Museum collections have been widely used as sources of biological samples for molecular biology studies and there are several methodologies and techniques to obtain and analyze DNA from tissues archived in museums, but most of these protocols have been developed for a specific tissue or are commercial kits. We present a simple protocol for extracting and amplifying DNA segments from sloth museum specimens. With this simple protocol we analyzed DNA fragments from 64% of 64 skin samples from three-toed sloths (Bradypus variegatus and Bradypus tridactylus archived in three different museums: 43 samples from the University of São Paulo Museum of Zoology (Museu de Zoologia da Universidade de São Paulo, MUZUSP São Paulo, São Paulo, Brazil; 18 samples from the Emílio Goeldi Museum (Museu Paraense Emílio Goeldi, MPEG, Belém, Pará, Brazil; and 3 samples from the Museum of Vertebrate Zoology (MVZ University of California, Berkeley, USA. The specimens sampled ranged in age from 18 to 108 years old. Our methodology allowed the recovery of up to 700 bp of mitochondrial DNA and 400 bp of nuclear genes. Thereafter, it is useful for genetic diversity studies of three-toed sloths and could be applied to other animals.

  7. Better movers and thinkers (BMT: A quasi-experimental study into the impact of physical education on children's cognition—A study protocol

    Directory of Open Access Journals (Sweden)

    Andrew Dalziell

    2015-01-01

    This protocol provides the details of the rationale and design of the study and details of the intervention, outcome measures, and the recruitment process. The study will address gaps within current research by evaluating if a change of approach in the delivery of PE within schools has an effect on children's cognition, PA habits, and GMC within a Scottish setting.

  8. Developing experimental protocols for chronic irradiation studies: the application of a good practice guide framework

    International Nuclear Information System (INIS)

    The EC-funded FASSET (Framework for Assessment of Environmental Impact) project collated information on the transfer, dosimetry, and effects of ionising radiation on wildlife. A major output from the project is the FASSET Radiation Effects Database (FRED). A review of the information contained within FRED highlighted that information on the effects of low-dose, chronic exposure was, at best, fragmentary. However, these data are required to define the dose effect relationships needed to underpin the assessment tools that are being developed. To address this requirement, a series of four Good Practice Guides (GPGs) has been produced as part of a protocol development framework. This framework aims to harmonise experimental approaches, with a view to ensuring that all necessary data on appropriate endpoints are collected, so that dose effect relationships can be determined. The GPGs cover test species selection, endpoint selection, radiation exposure and experimental design considerations. A key is used to guide researchers through the GPGs and the decisions made are recorded on an output pro-forma. The completed pro-forma forms the basis of the experimental protocol. The pro-forma also indicates the information that should be included when presenting the results of the experiment. Standardising approaches ensures that results are comparable between experiments and that they are suitable for determining dose effect relationships. This protocol development framework has been adopted by the UK Environment Agency as a document upon which future Agency-funded experimental work on the effects of chronic, low-level exposure to ionising radiation will be based. It is hoped that the framework will gain acceptance in the wider scientific community and facilitate addressing the knowledge gaps that have been identified in order that successful protection of non-human biota can be demonstrated. (author)

  9. The market for tradable GHG permits under the Kyoto Protocol: a survey of model studies

    International Nuclear Information System (INIS)

    This paper gathers results from 25 models of the market for tradable greenhouse gas (GHG) emission permits under the Kyoto Protocol. Due to diverging projections of emissions growth and different modeling approaches, the model results differ substantially. The average market volume is approximately 17 and 33 billion USD under global trading and Annex B trading, respectively. Including non-carbon GHG lowers compliance costs and permit prices. In the absence of the US, permit demand roughly equals 'hot air' from the former Soviet Union. These countries can increase their revenues from selling permits by restricting supply, which raises the permit price. (author)

  10. The market for tradable GHG permits under the Kyoto Protocol. A survey of model studies

    International Nuclear Information System (INIS)

    This paper gathers results from 25 models of the market for tradable greenhouse gas (GHG) emission permits under the Kyoto Protocol. Due to diverging projections of emissions growth and different modeling approaches, the model results differ substantially. The average market volume is approximately 17 and 33 billion USD under global trading and Annex B trading, respectively. Including non-carbon GHG lowers compliance costs and permit prices. In the absence of the US, permit demand roughly equals 'hot air' from the former Soviet Union. These countries can increase their revenues from selling permits by restricting supply, which raises the permit price

  11. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    Science.gov (United States)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. Methods and Findings We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were “bothersome,” a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc

  12. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    Science.gov (United States)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. Methods and Findings We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were “bothersome,” a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc

  13. Clean Development Mechanism” projects in the developing countries within the Kyoto protocol: problem analysis of a case study in Morocco

    Directory of Open Access Journals (Sweden)

    Gaglioppa P

    2009-11-01

    Full Text Available An internship period spent in the north of Morocco kingdom (Tetouan gave a contribute to the organization activity in promoting sustainable development in the rural areas under the Kyoto Protocol. The multitasking project will increase biodiversity planting trees for wood, forage and fruits productions. The paper show a first step study to evaluate the possibility to reach an agreement with the propriety and the manager of these areas in a multifunctional reforestation project. The eligible site suitable for reforestation in accordance with the CDM international scheme is a large plateau (more than 5000 hectares 600 meters high on the sea level far from the Cannabis crops area. The evaluation of the project costs and of the social benefits for the population consider (using different species the indigenous communities necessity. The evaluation of carbon sequestration show the small scale of the reforestation project on behalf of the Kyoto Protocol, but give also an idea about the people rights and necessities. The normal afforestation and reforestation projects, under the Kyoto Protocol, try to maximize the CO2 sequestration in a short time, than business laws usually require. A small scale project could be self-managing, less expensive (international certification costs and more interesting for local communities.

  14. Developing a comprehensive presurgical functional MRI protocol for patients with intractable temporal lobe epilepsy: a pilot study

    International Nuclear Information System (INIS)

    Our aim was to put together and test a comprehensive functional MRI (fMRI) protocol which could compete with the intracarotid amytal (IAT) or Wada test for the localisation of language and memory function in patients with intractable temporal lobe epilepsy. The protocol was designed to be performed in under 1 h on a standard 1.5 tesla imager. We used five paradigms to test nine healthy right-handed subjects: complex scene-encoding, picture-naming, reading, word-generation and semantic-decision tasks. The combination of these tasks generated two activation maps related to memory in the mesial temporal lobes, and three language-related maps of activation in a major part of the known language network. The functional maps from the encoding and naming tasks showed typical and symmetrical posterior mesial temporal lobe activation related to memory in all subjects. Only four of nine subjects also showed symmetrical anterior hippocampal activation. Language lateralisation was best with the word generation and reading paradigms and proved possible in all subjects. The reading paradigm enables localisation of language function in the left anterior temporal pole and middle temporal gyrus, areas typically resected during epilepsy surgery. The combined results of this comprehensive f MRI protocol are adequate for a comparative study with the IAT in patients with epilepsy being assessed for surgery. (orig.)

  15. INTERNATIONAL POLICY LAW STUDIES OF KYOTO PROTOCOL 1997 ABOUT GLOBAL WARMING

    Directory of Open Access Journals (Sweden)

    Noer Indriati

    2016-03-01

    Full Text Available Global warming or Global Warming that occurs is not currently an issue which can be resolved quickly. Need awareness together to solve this problem, because the impact is felt all over the world. Developed countries must be responsible in emission reduction as a form of spirit of shared responsibility and vary, although developing countries will also do the same. This research used the juridical normative approach, with secondary data composed of materials of primary legal materials either law, secondary law materials and materials law tertier as a source of law. Legal political activity is to specify an option regarding objectives and how to be used to achieve the objectives of the law in the community. With regard to the Kyoto Protocol of 1997, the ways of achievement of that goal was left to each country, so that it can be set up in accordance with the conditions of the country concerned. The States parties have not yet fully accept the Kyoto Protocol of 1997 so that the target of emission decline/QELROs listed in article 3 has not been fully achieved.

  16. The water maze paradigm in experimental studies of chronic cognitive disorders: Theory, protocols, analysis, and inference.

    Science.gov (United States)

    Kapadia, Minesh; Xu, Josie; Sakic, Boris

    2016-09-01

    An instrumental step in assessing the validity of animal models of chronic cognitive disorders is to document disease-related deficits in learning/memory capacity. The water maze (WM) is a popular paradigm because of its low cost, relatively simple protocol and short procedure time. Despite being broadly accepted as a spatial learning task, inference of generalized, bona fide "cognitive" dysfunction can be challenging because task accomplishment is also reliant on non-cognitive processes. We review theoretical background, testing procedures, confounding factors, as well as approaches to data analysis and interpretation. We also describe an extended protocol that has proven useful in detecting early performance deficits in murine models of neuropsychiatric lupus and Alzheimer's disease. Lastly, we highlight the need for standardization of inferential criteria on "cognitive" dysfunction in experimental rodents and exclusion of preparations of a limited scientific merit. A deeper appreciation for the multifactorial nature of performance in WM may also help to reveal other deficits that herald the onset of neurodegenerative brain disorders. PMID:27229758

  17. Pemanfaatan Jaringan Komputer Untuk Aplikasi IPTV (Internet Protocol Television Studi Kasus Akatel Sandhy Putra Purwokerto

    Directory of Open Access Journals (Sweden)

    Galih Sasmi Ramdhani

    2010-11-01

    Full Text Available Internet Protocol Television (IPTV adalah suatu pengembangan baru dalam software komunikasi client-server yang mem-broadcast video yang berkualitas tinggi melalui jaringan internet protocol. IPTV melayani baik siaran langsung (live maupun program atau video yang tersimpan di server. Streaming adalah sebuah teknologi untuk memainkan file video atau audio secara langsung ataupun dengan prerecorded dari sebuah mesin server. File video atau audio  yang terletak pada server dapat secara langsung dijalankan pada komputer client sesaat setelah ada permintaan dari users sehingga proses download yang menghabiskan waktu cukup lama dapat dihindari. Digital Video Broadcasting (DVB adalah salah satu sistem yang digunakan untuk mentransmisikan siaran TV / Video digital hingga sampai ke pengguna akhir (end-user. Proses Transmisi siaran TV umumnya masih menggunakan metode analog, maka dengan adanya streaming TV channel berbasis DVB merupakan suatu perkembangan distribusi siaran televisi yang tadinya secara analog menjadi digital. Oleh karena itu pada penelitian ini akan dibahas mengenai aplikasi IPTV yang berbasis DVB dengan metode streaming pada Ubuntu 9.04 yang merupakan distro Linux dengan media transmisi Wireless LAN Akatel Sandhy Putra Purwokerto. Metode streaming yang digunakan adalah broadcast yaitu pengiriman data, dimana data dikirimkan ke banyak titik sekaligus, tanpa melakukan pengecekan apakah titik tersebut siap atau tidak, atau tanpa memperhatikan apakah data itu sampai atau tidak. Contoh penggunaan sistem ini adalah siaran televisi dan radio.

  18. Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial

    OpenAIRE

    Lee, Seunghoon; Kim, Joo-Hee; Shin, Kyung-Min; Kim, Jung-Eun; Kim, Tae-Hun; Kang, Kyung-Won; Lee, Minhee; Jung, So-Young; Shin, Mi-Suk; Kim, Ae-Ran; Park, Hyo-Ju; Hong, Kwon-Eui; Choi, Sun-Mi

    2013-01-01

    Background The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. Methods/design This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean ...

  19. A case study of machinery maintenance protocols and procedures within the UK utilities sector.

    Science.gov (United States)

    Edwards, David J; Love, Peter E D

    2016-08-01

    Failure to conduct periodic fixed-time-to (or scheduled) maintenance on off-highway plant and equipment represents a significant health and safety hazard and major litigation risk for utility contractors completing service excavation and reinstatement works on public highways. Mini-excavators are a ubiquitous mobile plant item used for such tasks and have recently been responsible for several major injuries and fatalities involving workers and members of the public in the United Kingdom (UK). The research utilises the method of triangulation to examine the maintenance practices of utility contractors in the UK. Findings from the research reveal that a combination of prevailing market forces and internal 'company' pressures have inadvertently removed knowledgeable and trained operators, site foremen and managerial supervisors from hands-on maintenance inspections. Rather, 'virtual' maintenance protocols and procedures are adopted by head office but rarely fully implemented on-site. The research concludes with pragmatic recommendations and direction for future research. PMID:26545910

  20. A longitudinal, multi-level comparative study of quality and safety in European hospitals: the QUASER study protocol

    Directory of Open Access Journals (Sweden)

    Weggelaar Anne-Marie

    2011-10-01

    Full Text Available Abstract Background although there is a wealth of information available about quality improvement tools and techniques in healthcare there is little understanding about overcoming the challenges of day-to-day implementation in complex organisations like hospitals. The 'Quality and Safety in Europe by Research' (QUASER study will investigate how hospitals implement, spread and sustain quality improvement, including the difficulties they face and how they overcome them. The overall aim of the study is to explore relationships between the organisational and cultural characteristics of hospitals and how these impact on the quality of health care; the findings will be designed to help policy makers, payers and hospital managers understand the factors and processes that enable hospitals in Europe to achieve-and sustain-high quality services for their patients. Methods/design in-depth multi-level (macro, meso and micro-system analysis of healthcare quality policies and practices in 5 European countries, including longitudinal case studies in a purposive sample of 10 hospitals. The project design has three major features: • a working definition of quality comprising three components: clinical effectiveness, patient safety and patient experience • a conceptualisation of quality as a human, social, technical and organisational accomplishment • an emphasis on translational research that is evidence-based and seeks to provide strategic and practical guidance for hospital practitioners and health care policy makers in the European Union. Throughout the study we will adopt a mixed methods approach, including qualitative (in-depth, narrative-based, ethnographic case studies using interviews, and direct non-participant observation of organisational processes and quantitative research (secondary analysis of safety and quality data, for example: adverse incident reporting; patient complaints and claims. Discussion the protocol is based on the premise that

  1. Boron neutron capture therapy applied to advanced breast cancers: Engineering simulation and feasibility study of the radiation treatment protocol

    Science.gov (United States)

    Sztejnberg Goncalves-Carralves, Manuel Leonardo

    This dissertation describes a novel Boron Neutron Capture Therapy (BNCT) application for the treatment of human epidermal growth factor receptor type 2 positive (HER2+) breast cancers. The original contribution of the dissertation is the development of the engineering simulation and the feasibility study of the radiation treatment protocol for this novel combination of BNCT and HER2+ breast cancer treatment. This new concept of BNCT, representing a radiation binary targeted treatment, consists of the combination of two approaches never used in a synergism before. This combination may offer realistic hope for relapsed and/or metastasized breast cancers. This treatment assumes that the boronated anti-HER2 monoclonal antibodies (MABs) are administrated to the patient and accumulate preferentially in the tumor. Then the tumor is destroyed when is exposed to neutron irradiation. Since the use of anti-HER2 MABs yields good and promising results, the proposed concept is expected to amplify the known effect and be considered as a possible additional treatment approach to the most severe breast cancers for patients with metastasized cancer for which the current protocol is not successful and for patients refusing to have the standard treatment protocol. This dissertation makes an original contribution with an integral numerical approach and proves feasible the combination of the aforementioned therapy and disease. With these goals, the dissertation describes the theoretical analysis of the proposed concept providing an integral engineering simulation study of the treatment protocol. An extensive analysis of the potential limitations, capabilities and optimization factors are well studied using simplified models, models based on real CT patients' images, cellular models, and Monte Carlo (MCNP5/X) transport codes. One of the outcomes of the integral dosimetry assessment originally developed for the proposed treatment of advanced breast cancers is the implementation of BNCT

  2. Cryptographic Protocols:

    DEFF Research Database (Denmark)

    Geisler, Martin Joakim Bittel

    cryptography was thus concerned with message confidentiality and integrity. Modern cryptography cover a much wider range of subjects including the area of secure multiparty computation, which will be the main topic of this dissertation. Our first contribution is a new protocol for secure comparison, presented...... framework. We call this framework VIFF, short for Virtual Ideal Functionality Framework. VIFF implements a UC functionality for general multiparty computation on asynchronous networks. We give a formal definition of the functionality in Chapter 3. There we also describe how we implemented the functionality...... no information is released. The communication complexity of this protocol is the same as that of a passively secure solution up to a constant factor. It is secure against an adaptive and active adversary corrupting less than n=3 players. Following the presentation of VIFF, we turn to a more theoretical subject...

  3. Rational Protocols

    Science.gov (United States)

    Cachin, Christian

    Security research continues to provide a plethora of new protocols and mechanisms; these solutions patch either existing vulnerabilities found in practical systems or solve hypothetical security problems in the sense that the problem is often conceived at the same time when the first solution is proposed. Yet only a very small fraction of this research is relevant to ordinary users in the sense that they are willing to actually deploy the technology.

  4. Development of a Protocol for Epidemiologal Studies of Whole-Body Vibration and Musculoskeletal Disorders of the Lower Back

    Science.gov (United States)

    Magnusson, M. L.; Pope, M. H.; Hulshof, C. T. J.; Bovenzi, M.

    1998-08-01

    It seems evident from a large number of studies that there is a positive relationship between exposure to whole body vibration (WBV) and the occurrence of low back pain. There are existing standards for evaluating the human exposure to WBV, which are based on other factors than the effect of musculoskeletal disorders. Several national and international standards also exist for evaluating human exposure to WBV. The exposure limit values or health guidance caution zones included in some of these standards are not or only to a limited extent based on systematic epidemiological investigations. It has not yet been possible to establish a clear exposure-response relationship. There are many confounding or contributing factors which influence the hazards to workers caused by exposure to WBV. Reliable methods for the detection and prevention of injury due to vibration exposure at work, alone or in combination with other risk factors, need to be implemented. The aim of this paper was to design a protocol and a questionnaire for conducting collaborative studies of WBV and musculoskeletal back disorders. The protocol will be tested in a pilot study before it will be used in multi-center studies.

  5. Improving care for victims: a study protocol of the evaluation of a centre for sexual and family violence

    Science.gov (United States)

    Zijlstra, E; LoFoWong, S; Hutschemaekers, G; Lagro-Janssen, A

    2016-01-01

    Introduction Worldwide, sexual and family violence are highly prevalent problems. Victims of sexual and family violence often do not seek formal help in the acute phase. When they do seek help, they encounter a system of scattered care. For this reason, a centre for sexual and family violence was launched in Nijmegen, the Netherlands. The centre provides multidisciplinary care for victims of acute sexual and/or family violence. With the study described in this study protocol, we want to evaluate the implementation process and the reach of the Center for Sexual and Family Violence Nijmegen (CSFVN). Methods and analysis We will conduct a mixed-methods study including quantitative and qualitative methods of data collection and analysis. Data about the implementation process will be obtained via semistructured interviews and focus group discussions. Content analysis will be done in software program Atlas.ti. Analysis of file data will be undertaken to assess the reach of the CSFVN (patient characteristics and characteristics of the care they received). The data will be analysed in SPSS. Ethics and dissemination The Medical Ethics Committee of the Radboud University Nijmegen Medical Center approved the study protocol under file number 2012–1218. Dissemination will be done by submitting scientific articles to academic peer-reviewed journals. We will present the results at relevant international, national and local conferences and meetings. We will send press releases to relevant media. We will share the results with the network of assault centres in the Netherlands. PMID:27619828

  6. The “Healthy Habits, Healthy Girls” randomized controlled trial for girls: study design, protocol, and baseline results

    Directory of Open Access Journals (Sweden)

    Ana Carolina Barco Leme

    2015-07-01

    Full Text Available The purpose of this article is to describe the study design, protocol, and baseline results of the “Healthy Habits, Healthy Girls” program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices. There were no significant differences between the groups for most of the variables, except age (p = 0.000 and waist circumference (p = 0.014. The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  7. A protocol for the development of Mediterranean climate services based on the experiences of the CLIM-RUN case studies

    Science.gov (United States)

    Goodess, Clare; Ruti, Paolo; Rousset, Nathalie

    2014-05-01

    During the closing stages of the CLIM-RUN EU FP7 project on Climate Local Information in the Mediterranean region Responding to User Needs, the real-world experiences encountered by the case-study teams are being assessed and synthesised to identify examples of good practice and, in particular, to produce the CLIM-RUN protocol for the development of Mediterranean climate services. The specific case studies have focused on renewable energy (Morocco, Spain, Croatia, Cyprus), tourism (Savoie, Tunisia, Croatia, Cyprus) and wild fires (Greece) as well as one cross-cutting case study (Veneto region). They have been implemented following a common programme of local workshops, questionnaires and interviews, with Climate Expert Team and Stakeholder Expert Team members collaborating to identify and translate user needs and subsequently develop climate products and information. Feedback from stakeholders has been essential in assessing and refining these products. The protocol covers the following issues: the overall process and methodological key stages; identification and selection of stakeholders; communication with stakeholders; identification of user needs; translation of needs; producing products; assessing and refining products; methodologies for evaluating the economic value of climate services; and beyond CLIM-RUN - the lessons learnt. Particular emphasis is given to stakeholder analysis in the context of the participatory, bottom-up approach promoted by CLIM-RUN and to the iterative approach taken in the development of climate products. Recommendations are also made for an envisioned three-tier business model for the development of climate services involving climate, intermediary and stakeholder tiers.

  8. Building America Case Study: Philadelphia Housing Authority Energy-Efficiency Turnover Protocols, Philadelphia, Pennsylvania

    Energy Technology Data Exchange (ETDEWEB)

    2016-02-01

    Over one million HUD-supported public housing units provide rental housing for eligible low-income families across the country. A survey of over 100 public housing authorities (PHAs) across the country indicated that there is a high level of interest in developing low-cost solutions that improve energy efficiency and can be seamlessly included in the refurbishment process. Further, PHAs, have incentives (both internal and external) to reduce utility bills. ARIES worked with four PHAs to develop packages of energy efficiency retrofit measures the PHAs can cost-effectively implement with their own staffs in the normal course of housing operations at the time when units are refurbished between occupancies. The energy efficiency turnover protocols emphasized air infiltration reduction, duct sealing, and measures that improve equipment efficiency. ARIES documented implementation in 18 housing units. Reductions in average air leakage were 16 percent and duct leakage reductions averaged 23 percent. Total source energy consumption savings due to implemented measures was estimated at 3-10 percent based on BEopt modeling with a simple payback of 1.6 to 2.5 years. Implementation challenges were encountered mainly related to required operational changes and budgetary constraints. Nevertheless, simple measures can feasibly be accomplished by PHA staff at low or no cost. At typical housing unit turnover rates, these measures could impact hundreds of thousands of units per year nationally.

  9. Using Think-Aloud Protocols to Uncover Misconceptions and Improve Developmental Math Instruction: An Exploratory Study

    Directory of Open Access Journals (Sweden)

    Charles Secolsky

    2016-01-01

    Full Text Available Deficiencies in education continue to escalate around the world. The focus on outcomes assessment has narrowed instructional research and curriculum evaluation to standardized testing in certain subject areas. A prototype for a quantitative literacy assessment instrument was developed with the goal of diagnosing student misconceptions of basic mathematics content and changing instructional practices to undo the misconceptions by applying cognitive psychological theory. Two hundred thirty-eight basic math high school students and 209 remedial community college students in New Jersey and New York were administered the instrument, which had been based on coded data from think-aloud protocols. The instrument asked students to answer 20 basic mathematics items and, in addition, to evaluate four possible solution strategies. For each item, frequencies of selected solution strategies and the association between strategy selection and performance on the 20-question math test are presented as a means for improving instruction. Follow-up research is proposed for determining whether undoing the student misconceptions first before teaching material on a new unit of instruction may yield more positive student outcomes.

  10. Evaluating the impact of environmental interventions across 2 countries: the International Bikeshare Impacts on Cycling and Collisions Study (IBICCS) Study protocol

    OpenAIRE

    Fuller, Daniel; Gauvin, Lise; Dube, Anne-Sophie; Winters, Meghan; Teschke, Kay; Russo, Elizabeth; Camden, Andi; Mee, Carol; Friedman, Steven

    2014-01-01

    Background Few international studies examine public bicycle share programs (PBSP) health impacts. We describe the protocol for the International Bikeshare Impacts on Cycling and Collisions Study (IBICCS). Methods A quasi-experimental non-equivalent groups design was used. Intervention cities (Montreal, Toronto, Boston, New York and Vancouver) were matched to control cities (Chicago, Detroit, and Philadelphia) on total population, population density, cycling rates, and average yearly temperatu...

  11. Histology protocols

    Directory of Open Access Journals (Sweden)

    CarloAlberto Redi

    2010-06-01

    Full Text Available Tim D. Hewitson & Ian A. Darby (Eds Humana press, Totowa, New Jersey (USA Series: Springer Protocols Methods in Molecular Biology, Volume 611, 2010 Pages: 230; € 83.15 ISBN: 978-1-60327-344-2 Impressive as it can sounds in the era that Biology see a clear dominance of reductionism with the idea that complexity can be disentagled more and more thanks to the use of molecular tools, the reader will remain fascinated by this slim and agile volume devoted to bring together what apparently are two separeted words: molecular biology and histology. Simply remembering to the youngest scientists.....

  12. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  13. Comparative Evaluation of Stroke Triage Algorithms for Emergency Medical Dispatchers (MeDS: Prospective Cohort Study Protocol

    Directory of Open Access Journals (Sweden)

    Bloom Evan

    2011-01-01

    Full Text Available Abstract Background Stroke is a major cause of death and leading cause of disability in the United States. To maximize a stroke patient's chances of receiving thrombolytic treatment for acute ischemic stroke, it is important to improve prehospital recognition of stroke. However, it is known from published reports that emergency medical dispatchers (EMDs using Card 28 of the Medical Priority Dispatch System protocols recognize stroke poorly. Therefore, to improve EMD's recognition of stroke, the National Association of Emergency Medical Dispatchers recently designed a new diagnostic stroke tool (Cincinnati Stroke Scale -CSS to be used with Card 28. The objective of this study is to determine whether the addition of CSS improves diagnostic accuracy of stroke triage. Methods/Design This prospective experimental study will be conducted during a one-year period in the 911 call center of Santa Clara County, CA. We will include callers aged ≥ 18 years with a chief complaint suggestive of stroke and second party callers (by-stander or family who are in close proximity to the patient and can administer the tool ≥ 18 years of age. Life threatening calls will be excluded from the study. Card 28 questions will be administered to subjects who meet study criteria. After completion of Card 28, CSS tool will be administered to all calls. EMDs will record their initial assessment of a cerebro-vascular accident (stroke after completion of Card 28 and their final assessment after completion of CSS. These assessments will be compared with the hospital discharge diagnosis (ICD-9 codes recorded in the Office of Statewide Health Planning and Development (OSHPD database after linking the EMD database and OSHPD database using probabilistic linkage. The primary analysis will compare the sensitivity of the two stroke protocols using logistic regression and generalizing estimating equations to account for clustering by EMDs. To detect a 15% difference in sensitivity

  14. Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: A national multicentre study

    DEFF Research Database (Denmark)

    Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole;

    2012-01-01

    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....

  15. Study, design and realization of a fault-tolerant and predictable synchronous communication protocol on off-the-shelf components

    International Nuclear Information System (INIS)

    This PhD thesis contributes to the design and realization of safety-critical real-time systems on multiprocessor architectures with distributed memory. They are essential to compute systems that have to ensure complex and critical functions. This PhD thesis deals with communication media management. The communication management conditions strongly the capability of the system to fulfill the timeliness property and the dependability requirements. Our contribution includes: - The design of predictable and fault-tolerant synchronous communication protocol; - The study and the definition of the execution model to have a efficient and safe communications management; - The proposal of a method to generate automatically the communications scheduling. Our approach is based on a communication model that allows the analysis of the feasibility, before execution, of a distributed safe-critical real-time system with timeliness and safety requirements. This leads to the definition of an execution model based on a time-triggered and parallel communication management. A set of linear constraints system is generated automatically to compute the network scheduling and the network load with timeliness fulfillment. Then, the proposed communication interface is based on an advanced version of TDMA protocol which allows to use proprietary components (TTP, FlexRay) as well as standard components (Ethernet). The concepts presented in this thesis lead to the realisation and evaluation of a prototype within the framework of the OASIS project done at the CEA/List. (author)

  16. A protocol for classifying normal- and flat-arched foot posture for research studies using clinical and radiographic measurements

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2009-07-01

    Full Text Available Abstract Background There are several clinical and radiological methods available to classify foot posture in research, however there is no clear strategy for selecting the most appropriate measurements. Therefore, the aim of this study was to develop a foot screening protocol to distinguish between participants with normal- and flat-arched feet who would then subsequently be recruited into a series of laboratory-based gait studies. Methods The foot posture of ninety-one asymptomatic young adults was assessed using two clinical measurements (normalised navicular height and arch index and four radiological measurements taken from antero-posterior and lateral x-rays (talus-second metatarsal angle, talo-navicular coverage angle, calcaneal inclination angle and calcaneal-first metatarsal angle. Normative foot posture values were taken from the literature and used to recruit participants with normal-arched feet. Data from these participants were subsequently used to define the boundary between normal- and flat-arched feet. This information was then used to recruit participants with flat-arched feet. The relationship between the clinical and radiographic measures of foot posture was also explored. Results Thirty-two participants were recruited to the normal-arched study, 31 qualified for the flat-arched study and 28 participants were classified as having neither normal- or flat-arched feet and were not suitable for either study. The values obtained from the two clinical and four radiological measurements established two clearly defined foot posture groups. Correlations among clinical and radiological measures were significant (p r = 0.24 to 0.70. Interestingly, the clinical measures were more strongly associated with the radiographic angles obtained from the lateral view. Conclusion This foot screening protocol provides a coherent strategy for researchers planning to recruit participants with normal- and flat-arched feet. However, further research is

  17. Evaluation of methodological protocols using point counts and mist nets: a case study in southeastern Brazil

    Directory of Open Access Journals (Sweden)

    Vagner Cavarzere

    2013-01-01

    Full Text Available Despite their wide use in ornithological surveys, point counts and mist nets follow protocols developed in temperate regions, with little attention to possible modifications for tropical systems. Using these methods on a 3-month basis from December 2009-January 2011 in two forest fragments in southeastern Brazil, we wished to evaluate how long these locations needed to be surveyed with point counts for a relatively complete avifaunal inventory (at least 90% of all species and contacts, and if mist net hourly captures can equally detect numbers of species and individuals. Daily counting with four 20-min points during five consecutive days in a rain forest (MC detected 90% of the estimated species richness after 20 h (60 20-min point counts, while 17 h (51 20-min point counts did not detect 90% of the estimated species richness in a semideciduous forest (IT. The first 5 min of point counting in MC (63% of all species and in IT (65% detected significantly more species than the remaining minutes, but it took 15 min to accumulate 86% of all contacts in both forests. Consecutive 5-day mist netting (~ 9 h/day resulted in 70.5 net-h/m² (MC and 74.8 net-h/m² (IT of sample effort, but 80-85% of the estimated number of species was obtained. Although accumulation curves showed no tendency towards stabilization of the number of observed species, the estimated number of species began to stabilize after the first 20 h in both forests. There was no significant difference in capture rates for both species richness and abundance among hourly net checks, but a trend in which these parameters were highest between the second and fourth checks of the day was observed. A 3-day (43.8 and 63.3 net-h/m² mist netting section was enough to record 90% of the species captured during five days in MC and IT, respectively, while precise enough not to jeopardize species richness estimation. The number of individuals, however, decreased order 34% in MC and 38% in IT under the

  18. The Agricultural Model Intercomparison and Improvement Project (AgMIP): Protocols and Pilot Studies

    Science.gov (United States)

    Rosenzweig, C.; Jones, J. W.; Hatfield, J. L.; Ruane, A. C.; Boote, K. J.; Thorburn, P.; Antle, J. M.; Nelson, G. C.; Porter, C.; Janssen, S.; Asseng, S.; Basso, B.; Ewert, F.; Wallach, D.; Baigorria, G.; Winter, J. M.

    2012-01-01

    The Agricultural Model Intercomparison and Improvement Project (AgMIP) is a major international effort linking the climate, crop, and economic modeling communities with cutting-edge information technology to produce improved crop and economic models and the next generation of climate impact projections for the agricultural sector. The goals of AgMIP are to improve substantially the characterization of world food security due to climate change and to enhance adaptation capacity in both developing and developed countries. Analyses of the agricultural impacts of climate variability and change require a transdisciplinary effort to consistently link state-of-the-art climate scenarios to crop and economic models. Crop model outputs are aggregated as inputs to regional and global economic models to determine regional vulnerabilities, changes in comparative advantage, price effects, and potential adaptation strategies in the agricultural sector. Climate, Crop Modeling, Economics, and Information Technology Team Protocols are presented to guide coordinated climate, crop modeling, economics, and information technology research activities around the world, along with AgMIP Cross-Cutting Themes that address uncertainty, aggregation and scaling, and the development of Representative Agricultural Pathways (RAPs) to enable testing of climate change adaptations in the context of other regional and global trends. The organization of research activities by geographic region and specific crops is described, along with project milestones. Pilot results demonstrate AgMIP's role in assessing climate impacts with explicit representation of uncertainties in climate scenarios and simulations using crop and economic models. An intercomparison of wheat model simulations near Obregón, Mexico reveals inter-model differences in yield sensitivity to [CO2] with model uncertainty holding approximately steady as concentrations rise, while uncertainty related to choice of crop model increases with

  19. Study to the effectiveness of the UNECE Persistent Organic Pollutants (POP). Protocol and cost of additional measures. Phase II: Estimated emission reduction and cost of options for a possible revision of the POP Protocol

    NARCIS (Netherlands)

    Denier van der Gon, H.A.C.; Visschedijk, A.J.H.; Bolscher, M. van het

    2006-01-01

    The rationale is that during the review of the POP Protocol there will be a need for an assessment of the potential for further emission reduction and costs of a possible revision of the Protocol. The sources of POPs listed in the Protocol that are to be addressed revision of the POP Protocol have b

  20. A new perspective on adolescent athletes’ transition into upper secondary school: A longitudinal mixed methods study protocol

    Directory of Open Access Journals (Sweden)

    Tatiana V. Ryba

    2016-12-01

    Full Text Available The challenge of combining elite sport and education into a dual career pathway remains to be a source of concern for many high-performance athletes. Previous research findings suggest that committed participation in both domains is highly demanding and success in one pursuit often comes at the expense of the other. There are emergent studies, however, that argue for the beneficial and complementary nature of dual career pathways. Consequently, we emphasize the importance of understanding the processes underlying differences in the development of athletes’ life trajectories. This article presents a study protocol to explore new methodological and analytical approaches that may extend current understandings of the ways psychological and sociocultural processes are interconnected in the construction of adolescent athletes’ identities, motivation, well-being, and career aspirations in the transitory social world.

  1. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

    Science.gov (United States)

    Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

    2016-01-01

    Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on

  2. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Benjamin Kasenda

    2016-06-01

    Full Text Available Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i the existence and types of publication agreements in trial protocols, (ii the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii the frequency of co-authorship by industry employees.We used a retrospective cohort of randomized clinical trials (RCTs based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5% mentioned an agreement regarding publication of results. Of these 456, 393 (86.2% documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6% agreements were without constraints of publication. The remaining 24 (5.3% protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0% trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]. Of 71 agreements reported in publications, 52 (73.2% were concordant with those documented in the protocol. In 14 of 37 (37.8% publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements.Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do

  3. Ultrafast Cone-Beam Computed Tomography: A Comparative Study of Imaging Protocols during Image-Guided Therapy Procedure

    Directory of Open Access Journals (Sweden)

    Jijo Paul

    2015-01-01

    Full Text Available Objective. To evaluate two ultrafast cone-beam CT (UF-CBCT imaging protocols with different acquisition and injection parameters regarding image quality and required contrast media during image-guided hepatic transarterial chemoembolization (TACE. Methods. In 80 patients (male: 46, female: 34; mean age: 56.8 years; range: 33–83 UF-CBCT was performed during TACE for intraprocedural guidance. Imaging was performed using two ultrafast CBCT acquisition protocols with different acquisition and injection parameters (imaging protocol 1: acquisition time 2.54 s, and contrast 6 mL with 3 s delay; imaging protocol 2: acquisition time 2.72 s, and contrast 7 mL with 6 s delay. Image evaluation was performed with both qualitative and quantitative methods. Contrast injection volume and dose parameters were compared using values from the literature. Results. Imaging protocol 2 provided significantly better (P<0.05 image quality than protocol 1 at the cost of slightly higher contrast load and patient dose. Imaging protocol 1 provided good contrast perfusion but it mostly failed to delineate the tumors (P<0.05. On the contrary, imaging protocol 2 showed excellent enhancement of hepatic parenchyma, tumor, and feeding vessels. Conclusion. Tumor delineation, visualization of hepatic parenchyma, and feeding vessels are clearly possible using imaging protocol 2 with ultrafast CBCT imaging. A reduction of required contrast volume and patient dose were achieved due to the ultrafast CBCT imaging.

  4. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK

    Directory of Open Access Journals (Sweden)

    Wedderkopp Niels

    2012-08-01

    Full Text Available Abstract Background An increasingly passive life-style in the Western World has led to a rise in life-style related disorders. This is a major concern for all segments of society. The county council of the municipality of Svendborg in Denmark, created six Sport Schools with increased levels of suitable physical activities, which made it possible to study the health outcomes in these children whilst comparing them to children who attended the ‘normal’ schools of the region using the design of a “natural experiment”. Methods Children from the age of 6 till the age of 10, who accepted to be included in the monitoring process, were surveyed at baseline with questionnaires, physical examinations and physical and biological testing, including DXA scans. The physical examination and testing was repeated during the early stage of the study. Every week over the whole study period, the children will be followed with an automated mobile phone text message (SMS-Track asking questions on their leisure time sports activities and the presence of any musculoskeletal problems. Children who report any such problems are monitored individually by health care personnel. Data are collected on demography, health habits and attitudes, physical characteristics, physical activity using accelerometers, motor performance, fitness, bone health, life-style disorders, injuries and musculoskeletal problems. Data collection will continue at least once a year until the children reach grade 9. Discussion This project is embedded in a local community, which set up the intervention (The Sport Schools and thereafter invited researchers to provide documentation and evaluation. Sport schools are well matched with the ‘normal’ schools, making comparisons between these suitable. However, subgroups that would be specifically targeted in lifestyle intervention studies (such as the definitely obese could be relatively small. Therefore, results specific to minority groups may be

  5. Predictive Factors for Anastomotic Leakage After Colorectal Surgery: Study Protocol for a Prospective Observational Study (REVEAL Study)

    Science.gov (United States)

    Bosmans, Joanna WAM; Kartal, Serdar; Lubbers, Tim; Sosef, Meindert; Slooter, Gerrit D; Stoot, Jan H; van Schooten, Frederik-Jan; Bouvy, Nicole D; Derikx, Joep PM

    2016-01-01

    Background Anastomotic leakage (AL) remains the most important complication following colorectal surgery, and is associated with high morbidity and mortality rates. Previous research has focused on identifying risk factors and potential biomarkers for AL, but the sensitivity of these tests remains poor. Objective This prospective multicenter observational study aims at combining multiple parameters to establish a diagnostic algorithm for colorectal AL. Methods This study aims to include 588 patients undergoing surgery for colorectal carcinoma. Patients will be eligible for inclusion when surgery includes the construction of a colorectal anastomosis. Patient characteristics will be collected upon consented inclusion, and buccal swabs, breath, stool, and blood samples will be obtained prior to surgery. These samples will allow for the collection of information regarding patients’ inflammatory status, genetic predisposition, and intestinal microbiota. Additionally, breath and blood samples will be taken postoperatively and patients will be strictly observed during their in-hospital stay, and the period shortly thereafter. Results This study has been open for inclusion since August 2015. Conclusions An estimated 8-10% of patients will develop AL following surgery, and they will be compared to non-leakage patients. The objectives of this study are twofold. The primary aim is to establish and validate a diagnostic algorithm for the pre-operative prediction of the risk of AL development using a combination of inflammatory, immune-related, and genetic parameters. Previously established risk factors and novel parameters will be incorporated into this algorithm, which will aid in the recognition of patients who are at risk for AL. Based on these results, recommendations can be made regarding the construction of an anastomosis or deviating stoma, and possible preventive strategies. Furthermore, we aim to develop a new algorithm for the post-operative diagnosis of AL at an

  6. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK)

    DEFF Research Database (Denmark)

    Wedderkopp, Niels; Jespersen, Eva; Franz, Claudia;

    2012-01-01

    An increasingly passive life-style in the Western World has led to a rise in life-style related disorders. This is a major concern for all segments of society. The county council of the municipality of Svendborg in Denmark, created six Sport Schools with increased levels of suitable physical...... activities, which made it possible to study the health outcomes in these children whilst comparing them to children who attended the 'normal' schools of the region using the design of a "natural experiment"....

  7. Social facilitation maintenance treatment for adults with obesity: study protocol for a randomised-controlled feasibility study (SFM study)

    Science.gov (United States)

    Hilbert, Anja

    2016-01-01

    Introduction The long-term success of non-surgical weight loss treatment in adults with obesity is limited by substantial relapse, and only a few evidence-based weight loss maintenance treatments exist. This clinical trial investigates the feasibility and efficacy of a social facilitation maintenance programme for weight loss maintenance, tailored to meet the needs of obese adults who have undergone a lifestyle weight loss intervention. Methods and analysis In a single-centre, open feasibility trial, 72 adults currently or previously obese or overweight who have undergone a lifestyle weight loss intervention are centrally randomised to 4 months of social facilitation maintenance treatment or treatment as a usual control condition. In 16 outpatient group sessions, the social facilitation maintenance treatment, based on a socioecological model and on evidence supporting social facilitation as a key process in maintaining weight loss, focuses on promoting interpersonal relationships to build up a healthy lifestyle for long-term weight loss maintenance. Primary outcome is the amount of weight regain at 6-month follow-up, compared with pre-treatment weight, derived from measured body weight. Secondary outcomes address feasibility, including recruitment, attrition, assessment non-completion, compliance and patients' programme evaluation; and in comparison with pre-weight loss maintenance, social and interpersonal functioning, eating behaviour and physical activity, psychological and physical symptoms, body composition and risk of comorbidity, and quality of life at post-treatment and follow-up assessments. Ethics and dissemination The study was approved by the Ethical Committee at the University of Leipzig (165-13-15072013). The study results will be disseminated through peer-reviewed publications. Trial registration number DRKS00005182. PMID:27580827

  8. Validation of the automatic image analyser to assess retinal vessel calibre (ALTAIR): a prospective study protocol

    OpenAIRE

    Garcia-Ortiz, Luis; Gómez-Marcos, Manuel A.; Recio-Rodríguez, Jose I; Maderuelo-Fernández, Jose A; Chamoso-Santos, Pablo; Rodríguez-González, Sara; de Paz-Santana, Juan F; Merchan-Cifuentes, Miguel A; Corchado-Rodríguez, Juan M

    2014-01-01

    Introduction The fundus examination is a non-invasive evaluation of the microcirculation of the retina. The aim of the present study is to develop and validate (reliability and validity) the ALTAIR software platform (Automatic image analyser to assess retinal vessel calibre) in order to analyse its utility in different clinical environments. Methods and analysis A cross-sectional study in the first phase and a prospective observational study in the second with 4 years of follow-up. The study ...

  9. Prospective research on musculoskeletal disorders in office workers (PROMO) : Study protocol

    NARCIS (Netherlands)

    IJmker, S.; Blatter, B.M.; Beek, A.J. van der; Mechelen, W. van; Bongers, P.M.

    2006-01-01

    Background: This article describes the background and study design of the PROMO study (Prospective Research on Musculoskeletal disorders in Office workers). Few longitudinal studies have been performed to investigate the risk factors responsible for the incidence of hand, arm, shoulder and neck symp

  10. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hart Michael B

    2010-10-01

    Full Text Available Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools in Perth, Australia were recruited to the clustered (by school randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide

  11. Comparison of Standard 1.5 T vs. 3 T Optimized Protocols in Patients Treated with Glatiramer Acetate. A Serial MRI Pilot Study

    Directory of Open Access Journals (Sweden)

    Bianca Weinstock-Guttman

    2012-05-01

    Full Text Available This study explored the effect of glatiramer acetate (GA, 20 mg on lesion activity using the 1.5 T standard MRI protocol (single dose gadolinium [Gd] and 5-min delay or optimized 3 T protocol (triple dose of Gd, 20-min delay and application of an off-resonance saturated magnetization transfer pulse. A 15-month, phase IV, open-label, single-blinded, prospective, observational study included 12 patients with relapsing-remitting multiple sclerosis who underwent serial MRI scans (Days −45, −20, 0; the minus ign indicates the number of days before GA treatment; and on Days 30, 60, 90, 120, 150, 180, 270 and 360 during GA treatment on 1.5 T and 3 T protocols. Cumulative number and volume of Gd enhancing (Gd-E and T2 lesions were calculated. At Days −45 and 0, there were higher number (p < 0.01 and volume (p < 0.05 of Gd-E lesions on 3 T optimized compared to 1.5 T standard protocol. However, at 180 and 360 days of the study, no significant differences in total and cumulative number of new Gd-E and T 2 lesions were found between the two protocols. Compared to pre-treatment period, at Days 180 and 360 a significantly greater decrease in the cumulative number of Gd-E lesions (p = 0.03 and 0.021, respectively was found using the 3 T vs. the 1.5 T protocol (p = NS for both time points. This MRI mechanistic study suggests that GA may exert a greater effect on decreasing lesion activity as measured on 3 T optimized compared to 1.5 T standard protocol.

  12. Reducing radiation dose in 64-row spiral CT coronary angiography: study based on individualized scan dosage protocol

    International Nuclear Information System (INIS)

    Objective: To investigate the methods of reducing radiation dose in CT coronary angiography through optimizing individualized scan dosage protocol. Methods: Two hundred patients (group A) underwent coronary CTA examination which was performed with fixed 120 kV and variable mA according to their BMI. The mA was set as 150-300 mA (BMI < 18.5 kg/m2), 300-500 mA (18.5 kg/m2 ≤ BMI < 25.0 kg/m2), and 500-800 mA (BMI ≥ 25.0 kg/m2). When all examinations were finished, a linear regression was employed to analyze the correlation between mA and BMI, body surface (Suf), image noise (SD) respectively. The results of the analysis were used to formulate a regression equation, which was further used to establish a table list for quick search on how much mA that individualized coronary CTA scan would need. Another 200 patients (group B) enrolled for the individualized scan were scanned under new protocol that previous study established. The tube voltage was 100 and 120 kV. The tube current was variable according to the data in the table list. One-way ANOVA and Kruskal-wallis H test were used for statistics. Results: Regression equation between mA and BMI, Suf, SD was: mA =17.984 × BMI + 169.149 × Suf-2.282 × SD-361.039. The SD (group A: 32.08 ± 5.80, group B: 28.60±4.47), dose index volume (CTDIvol) [group A: (41.97 ± 11.37) mGy, group B: (33.18±10.07) mGy], effective dose(ED) [group A: (10.91 ±3.07) mSy, group B: (8.83 ±2.72)mSv] had significant differences between the two groups (F=43.45, 63.71, 49.07 respectively, P<0.01 for all). The SD and ED results obtained in group B were better than those in group A. Conclusion: Better performances were obtained when BMI combined Suf was used as a new individualized protocol than when BMI was used only, which means good image quality and lower radiation dosage in coronary CTA examination. (authors)

  13. Evaluation of the implementation of an 'oral hygiene protocol' in nursing homes: a 5-year longitudinal study

    NARCIS (Netherlands)

    Visschere, L. de; Baat, C. de; Schols, J.M.; Deschepper, E.; Vanobbergen, J.

    2011-01-01

    OBJECTIVES: To explore the long-term effects of the implementation of an oral hygiene protocol in nursing homes. METHODS: Out of 14 nursing homes (Flanders) seven nursing homes were randomly allocated to the intervention group and confirmed to implement an 'oral hygiene protocol'. The remaining nurs

  14. An Examination of the Design, Development, and Implementation of an Internet Protocol Version 6 Network: The ADTRAN Inc. Case Study

    Science.gov (United States)

    Perigo, Levi

    2013-01-01

    In this dissertation, the author examined the capabilities of Internet Protocol version 6 (IPv6) in regard to replacing Internet Protocol version 4 (IPv4) as the internetworking technology for Medium-sized Businesses (MBs) in the Information Systems (IS) field. Transition to IPv6 is inevitable, and, thus, organizations are adopting this protocol…

  15. Neuropsychiatric symptoms in patients with dementia in primary care: a study protocol

    NARCIS (Netherlands)

    Borsje, P.; Wetzels, R.B.; Lucassen, P.L.B.J.; Pot, A.M.; Koopmans, R.T.C.M.

    2014-01-01

    BACKGROUND: Neuropsychiatric symptoms (NPS) frequently occur in patients with dementia. To date, prospective studies on the course of NPS have been conducted in patients with dementia in clinical centers or psychiatric services. The primary goal of this study is to investigate the course of NPS in p

  16. Indoor air pollution on nurseries and primary schools: impact on childhood asthma – study protocol

    Directory of Open Access Journals (Sweden)

    Sousa Sofia I V

    2012-06-01

    Full Text Available Abstract Background Several studies have demonstrated an association between the exposure to indoor air pollution (IAP and childhood asthma. Evidence is suggesting that several air pollutants may contribute to both exacerbation and development of asthma, but some uncertainty remains concerning the specific causative role of IAP. This paper reports an epidemiologic study aiming to reduce the existing lacks on the association between long-term exposure to pollution mixtures and the development and exacerbation of childhood asthma. Methods/design Based on the implementation of the study in 8 nurseries and 8 primary schools, from which, 2 nurseries and 2 primary schools in sites influenced by traffic and other 2 nurseries and 2 primary schools in background sites at urban and rural areas, the study will analyse the exposure to both urban and rural pollution as well as to traffic emissions (some homes of the children will be included in the study. Furthermore, based on the answers to validated questionnaires (as those used in the International Study of Asthma and Allergies in Childhood - ISAAC filled in by the parents and on medical exams, the study will assess the prevalence, incidence and exacerbation of asthma, thus considering both short and long-term effects. The approximate number of children in the study will never be less than 600, guaranteeing 80% of study power (significant at a 5% level. Discussion This study intends to contribute for the understanding of the role of environmental factors, namely indoor air pollution, on asthma considering a risk group of different ages, and for the development of preventive measures, which are considered priority issues by the European Commission, according to the European Environmental Agency and the World Health Organization.

  17. Advancing Migrant Access to Health Services in Europe (AMASE): Protocol for a Cross-sectional Study

    OpenAIRE

    Fakoya, I; Álvarez-Del Arco, D.; Monge, S; Copas, A J; Gennotte, A. F.; Volny-Anne, A.; Göpel, S.; Touloumi, G.; Prins, M; Barros, H; Staehelin, C.; del Amo, J.; Burns, F. M.

    2016-01-01

    BACKGROUND: Migrants form a substantial proportion of the population affected by the human immunodeficiency virus (HIV) epidemic in Europe, yet HIV prevention for this population is hindered by poor understanding of access to care and of postmigration transmission dynamics. OBJECTIVE: We present the design and methods of the advancing Migrant Access to health Services in Europe (aMASE) study, the first European cross-cultural study focused on multiple migrant populations. It aims to identify ...

  18. Acupressure for agitation in nursing home residents with dementia: study protocol for a randomized controlled trial

    OpenAIRE

    Kwan, Rick Yiu Cho; Leung, Mason Chin Pang; Lai, Claudia Kam Yuk

    2014-01-01

    Background Agitation is prevalent among people with dementia (PWD) in nursing homes. It frustrates both the PWD and their caregivers. Acupressure is a non-pharmacological intervention whose effectiveness is supported by preliminary studies. However, there is still a dearth of evidence to explain its effect for clinical use and further research. The present study is being conducted primarily to investigate the effects of acupressure as compared with sham-acupressure and usual care. Methods/des...

  19. Study protocol: EXERcise and Cognition In Sedentary adults with Early-ONset dementia (EXERCISE-ON

    Directory of Open Access Journals (Sweden)

    Hooghiemstra Astrid M

    2012-08-01

    Full Text Available Abstract Background Although the development of early-onset dementia is a radical and invalidating experience for both patient and family there are hardly any non-pharmacological studies that focus on this group of patients. One type of a non-pharmacological intervention that appears to have a beneficial effect on cognition in older persons without dementia and older persons at risk for dementia is exercise. In view of their younger age early-onset dementia patients may be well able to participate in an exercise program. The main aim of the EXERCISE-ON study is to assess whether exercise slows down the progressive course of the symptoms of dementia. Methods/Design One hundred and fifty patients with early-onset dementia are recruited. After completion of the baseline measurements, participants living within a 50 kilometre radius to one of the rehabilitation centres are randomly assigned to either an aerobic exercise program in a rehabilitation centre or a flexibility and relaxation program in a rehabilitation centre. Both programs are applied three times a week during 3 months. Participants living outside the 50 kilometre radius are included in a feasibility study where participants join in a daily physical activity program set at home making use of pedometers. Measurements take place at baseline (entry of the study, after three months (end of the exercise program and after six months (follow-up. Primary outcomes are cognitive functioning; psychomotor speed and executive functioning; (instrumental activities of daily living, and quality of life. Secondary outcomes include physical, neuropsychological, and rest-activity rhythm measures. Discussion The EXERCISE-ON study is the first study to offer exercise programs to patients with early-onset dementia. We expect this study to supply evidence regarding the effects of exercise on the symptoms of early-onset dementia, influencing quality of life. Trial registration The present study is registered

  20. Genetic test feedback with weight control advice: study protocol for a randomized controlled trial

    OpenAIRE

    Meisel Susanne F; Beeken Rebecca J; van Jaarsveld Cornelia HM; Wardle Jane

    2012-01-01

    Abstract Background Genetic testing for risk of weight gain is already available over the internet despite uncertain benefits and concerns about adverse emotional or behavioral effects. Few studies have assessed the effect of adding genetic test feedback to weight control advice, even though one of the proposed applications of genetic testing is to stimulate preventive action. This study will investigate the motivational effect of adding genetic test feedback to simple weight control advice i...

  1. A conceptual framework for interprofessional shared decision making in home care: Protocol for a feasibility study

    OpenAIRE

    Murray Mary-Anne; Fraser Kimberley; Dumont Serge; Desroches Sophie; Brière Nathalie; Stacey Dawn; Légaré France; Sales Anne; Aubé Denise

    2011-01-01

    Abstract Background Shared decision making (SDM) is fundamental to informed consent and client-centered care. So far, SDM frameworks have been limited to the client-physician dyad, even though care is increasingly delivered by interprofessional (IP) teams. IP collaboration is especially essential in home care, one of health care's most rapidly growing areas. This study will assess whether it is possible to practice SDM in IP home care. Methods/Design We will use a qualitative case study and a...

  2. Measuring the relationship between interruptions, multitasking and prescribing errors in an emergency department: a study protocol

    OpenAIRE

    Raban, Magdalena Z; Scott R Walter; Douglas, Heather E.; Strumpman, Dana; Mackenzie, John; Westbrook, Johanna I

    2015-01-01

    Introduction Interruptions and multitasking are frequent in clinical settings, and have been shown in the cognitive psychology literature to affect performance, increasing the risk of error. However, comparatively less is known about their impact on errors in clinical work. This study will assess the relationship between prescribing errors, interruptions and multitasking in an emergency department (ED) using direct observations and chart review. Methods and analysis The study will be conducte...

  3. Family-Centered Care in Juvenile Justice Institutions: A Mixed Methods Study Protocol

    Science.gov (United States)

    Mulder, Eva; Rigter, Henk; Breuk, René; van der Vaart, Wander; Vermeiren, Robert

    2016-01-01

    Background Treatment and rehabilitation interventions in juvenile justice institutions aim to prevent criminal reoffending by adolescents and to enhance their prospects of successful social reintegration. There is evidence that these goals are best achieved when the institution adopts a family-centered approach, involving the parents of the adolescents. The Academic Workplace Forensic Care for Youth has developed two programs for family-centered care for youth detained in groups for short-term and long-term stay, respectively. Objective The overall aim of our study is to evaluate the family-centered care program in the first two years after the first steps of its implementation in short-term stay groups of two juvenile justice institutions in the Netherlands. The current paper discusses our study design. Methods Based on a quantitative pilot study, we opted for a study with an explanatory sequential mixed methods design. This pilot is considered the first stage of our study. The second stage of our study includes concurrent quantitative and qualitative approaches. The quantitative part of our study is a pre-post quasi-experimental comparison of family-centered care with usual care in short-term stay groups. The qualitative part of our study involves in-depth interviews with adolescents, parents, and group workers to elaborate on the preceding quantitative pilot study and to help interpret the outcomes of the quasi-experimental quantitative part of the study. Results We believe that our study will result in the following findings. In the quantitative comparison of usual care with family-centered care, we assume that in the latter group, parents will be more involved with their child and with the institution, and that parents and adolescents will be more motivated to take part in therapy. In addition, we expect family-centered care to improve family interactions, to decrease parenting stress, and to reduce problem behavior among the adolescents. Finally, we assume

  4. Reduction and technical simplification of testing protocol for walking based on repeatability analyses: An Interreg IVa pilot study

    Directory of Open Access Journals (Sweden)

    Nejc Sarabon

    2010-12-01

    Full Text Available The aim of this study was to define the most appropriate gait measurement protocols to be used in our future studies in the Mobility in Ageing project. A group of young healthy volunteers took part in the study. Each subject carried out a 10-metre walking test at five different speeds (preferred, very slow, very fast, slow, and fast. Each walking speed was repeated three times, making a total of 15 trials which were carried out in a random order. Each trial was simultaneously analysed by three observers using three different technical approaches: a stop watch, photo cells and electronic kinematic dress. In analysing the repeatability of the trials, the results showed that of the five self-selected walking speeds, three of them (preferred, very fast, and very slow had a significantly higher repeatability of the average walking velocity, step length and cadence than the other two speeds. Additionally, the data showed that one of the three technical methods for gait assessment has better metric characteristics than the other two. In conclusion, based on repeatability, technical and organizational simplification, this study helped us to successfully define a simple and reliable walking test to be used in the main study of the project.

  5. Large-Scale Wearable Sensor Deployment in Parkinson’s Patients: The Parkinson@Home Study Protocol

    Science.gov (United States)

    Hahn, Tim; de Vries, Nienke M; Cohen, Eli; Bataille, Lauren; Little, Max A; Baldus, Heribert; Bloem, Bastiaan R; Faber, Marjan J

    2016-01-01

    Background Long-term management of Parkinson’s disease does not reach its full potential because we lack knowledge about individual variations in clinical presentation and disease progression. Continuous and longitudinal assessments in real-life (ie, within the patients’ own home environment) might fill this knowledge gap. Objective The primary aim of the Parkinson@Home study is to evaluate the feasibility and compliance of using multiple wearable sensors to collect clinically relevant data. Our second aim is to address the usability of these data for answering clinical research questions. Finally, we aim to build a database for future validation of novel algorithms applied to sensor-derived data from Parkinson’s patients during daily functioning. Methods The Parkinson@Home study is a two-phase observational study involving 1000 Parkinson’s patients and 250 physiotherapists. Disease status is assessed using a short version of the Parkinson's Progression Markers Initiative protocol, performed by certified physiotherapists. Additionally, participants will wear a set of sensors (smartwatch, smartphone, and fall detector), and use these together with a customized smartphone app (Fox Insight), 24/7 for 3 months. The sensors embedded within the smartwatch and fall detector may be used to estimate physical activity, tremor, sleep quality, and falls. Medication intake and fall incidents will be measured via patients’ self-reports in the smartphone app. Phase one will address the feasibility of the study protocol. In phase two, mathematicians will distill relevant summary statistics from the raw sensor signals, which will be compared against the clinical outcomes. Results Recruitment of 300 participants for phase one was concluded in March, 2016, and the follow-up period will end in June, 2016. Phase two will include the remaining participants, and will commence in September, 2016. Conclusions The Parkinson@Home study is expected to generate new insights into the

  6. Elder mistreatment in a community dwelling population: the Malaysian Elder Mistreatment Project (MAESTRO) cohort study protocol

    Science.gov (United States)

    Choo, Wan Yuen; Hairi, Noran Naqiah; Sooryanarayana, Rajini; Yunus, Raudah Mohd; Hairi, Farizah Mohd; Ismail, Norliana; Kandiben, Shathanapriya; Mohd Ali, Zainudin; Ahmad, Sharifah Nor; Abdul Razak, Inayah; Othman, Sajaratulnisah; Tan, Maw Pin; Mydin, Fadzilah Hanum Mohd; Peramalah, Devi; Brownell, Patricia; Bulgiba, Awang

    2016-01-01

    Introduction Despite being now recognised as a global health concern, there is still an inadequate amount of research into elder mistreatment, especially in low and middle-income regions. The purpose of this paper is to report on the design and methodology of a population-based cohort study on elder mistreatment among the older Malaysian population. The study aims at gathering data and evidence to estimate the prevalence and incidence of elder mistreatment, identify its individual, familial and social determinants, and quantify its health consequences. Methods and analysis This is a community-based prospective cohort study using randomly selected households from the national census. A multistage sampling method was employed to obtain a total of 2496 older adults living in the rural Kuala Pilah district. The study is divided into two phases: cross-sectional study (baseline), and a longitudinal follow-up study at the third and fifth years. Elder mistreatment was measured using instrument derived from the previous literature and modified Conflict Tactic Scales. Outcomes of elder mistreatment include mortality, physical function, mental health, quality of life and health utilisation. Logistic regression models are used to examine the relationship between risk factors and abuse estimates. Cox proportional hazard regression will be used to estimate risk of mortality associated with abuse. Associated annual rate of hospitalisation and health visit frequency, and reporting of abuse, will be estimated using Poisson regression. Ethics and dissemination The study has been approved by the Medical Ethics Committee of the University of Malaya Medical Center (MEC Ref 902.2) and the Malaysian National Medical Research Register (NMRR-12-1444-11726). Written consent was obtained from all respondents prior to baseline assessment and subsequent follow-up. Findings will be disseminated to local stakeholders via forums with community leaders, and health and social welfare departments

  7. Study Protocol - an exploratory trial on health promoting schools at Dutch secondary schools

    Directory of Open Access Journals (Sweden)

    Vincent Busch

    2012-07-01

    Full Text Available Background: Recent studies show adolescent health-related behaviours to co-occur synergistically. This paper describes the study design for an exploratory trial on the effects of a comprehensive, whole-school health promoting school intervention. This intervention tackles seven different behavioural domains simultaneously via a combination of education, creating a healthy environment and introducing healthy behavioural policies. Additionally, extensive partnerships are formed between schools, parents, neighbourhoods and youth health authorities to coordinate health promotion efforts.Study design and data collection methods: The intervention will be implemented at two secondary schools. Results will be compared with two control schools (n≈1500. The intervention's effectiveness in changing student behaviours as well as physical and psychosocial health status along with qualitative lessons learned on the integration of youth health care services and school health education practices are the main aimed outcomes of this study. Data are collected via a mixed methods design combining an annual youth health (behaviour monitor with a qualitative process evaluation via interviews with key stakeholders.Data analysis: A multilevel analysis is performed combined with a systematic analysis of qualitative interview data.Conclusions: This study will produce an evaluation of a comprehensive health promoting school intervention that combines an integrated approach of schools, neighbourhoods, families and youth health services to improve adolescent health.

  8. ïSCOPE: Safer care for older persons (in residential environments: A study protocol

    Directory of Open Access Journals (Sweden)

    Barnard Debbie

    2011-07-01

    Full Text Available Abstract Background The current profile of residents living in Canadian nursing homes includes elder persons with complex physical and social needs. High resident acuity can result in increased staff workload and decreased quality of work life. Aims Safer Care for Older Persons [in residential] Environments is a two year (2010 to 2012 proof-of-principle pilot study conducted in seven nursing homes in western Canada. The purpose of the study is to evaluate the feasibility of engaging front line staff to use quality improvement methods to integrate best practices into resident care. The goals of the study are to improve the quality of work life for staff, in particular healthcare aides, and to improve residents' quality of life. Methods/design The study has parallel research and quality improvement intervention arms. It includes an education and support intervention for direct caregivers to improve the safety and quality of their care delivery. We hypothesize that this intervention will improve not only the care provided to residents but also the quality of work life for healthcare aides. The study employs tools adapted from the Institute for Healthcare Improvement's Breakthrough Series: Collaborative Model and Canada's Safer Healthcare Now! improvement campaign. Local improvement teams in each nursing home (1 to 2 per facility are led by healthcare aides (non-regulated caregivers and focus on the management of specific areas of resident care. Critical elements of the program include local measurement, virtual and face-to-face learning sessions involving change management, quality improvement methods and clinical expertise, ongoing virtual and in person support, and networking. Discussion There are two sustainability challenges in this study: ongoing staff and leadership engagement, and organizational infrastructure. Addressing these challenges will require strategic planning with input from key stakeholders for sustaining quality improvement

  9. Study protocol: follow-up home visits with nutrition: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Beck Anne Marie

    2011-12-01

    Full Text Available Abstract Background Geriatric patients are at high risk of re-admission after discharge. Pre-existing nutritional risk amongst these patients is of primary concern, with former nutritional intervention studies being largely ineffective. None of these studies has included individual dietary counselling by a registered dietician or has considered competing medical conditions in the participants. A former randomised study has shown that comprehensive discharge follow-up in geriatric patients homes by general practitioners and district nurses was effective in reducing the re-admission risk in the intervention group compared to the control group. That study did not include a nutritional intervention. The purpose of this study is to assess the combined benefits of an intervention consisting of discharge follow-up in geriatric patients' home by a general practitioner and a registered dietician. Methods/design This single-blind randomised controlled study, will recruit 160 hospitalised geriatric medical patients (65+ y at nutritional risk. Participants will be randomly allocated to receive in their homes, either 12 weeks individualised nutritional counselling by a registered dietician complemented with follow-up by general practitioners or a 12 weeks follow-up by general practitioners alone. Discussion This trial is the first of its kind to provide individual nutritional intervention combined with follow-up by general practitioner as an intervention to reduce risk of re-admission after discharge among geriatric medical patients. The results will hopefully help to guide the development of more effective rehabilitation programs following hospital admissions, which may ultimately lead to reduced health care costs, and improvement in mobility, independence and quality of life for geriatric patients at nutritional risk. Trial Registration ClinicalTrials.gov 2010 NCT01249716

  10. DEGREE OF BURNOUT AMONG EMERGENCY HEALTHCARE WORKERS AND FACTORS INFLUENCING LEVEL OF BURNOUT: A STUDY PROTOCOL

    Directory of Open Access Journals (Sweden)

    Shyamanta

    2015-11-01

    Full Text Available BACKGROUND Burnout is a feeling of failure and exhaustion. It is felt both at the physical and emotional level. Depletion of the person’s resources is a consequence and also has an impact on the organisation. Nature of the work itself makes emergency healthcare workers vulnerable to burnout. METHOD This study is designed to measure the degree of burnout among emergency healthcare workers in a hospital and to identify the factors that influence burnout. The study has been approved by the institutional ethical committee. After obtaining informed consent, doctors, nurses and other healthcare workers who are working in the Emergency Department of the Gauhati Medical College Hospital, Guwahati, will form the study population. RESULT Sixty two healthcare workers will constitute the sample for the present study. The Assamese translation of the Maslach Burnout Inventory (MBI is the chosen tool to assess burnout. The data on demography, factors influencing the level of burnout, and the degree of burnout will be collected through structured questionnaires. The analysis is planned by both descriptive (such as mean, standard deviation, and frequency distribution as well as inferential (non-parametric test such as Chi-square statistics. CONCLUSION Knowledge about the degree of burnout among the emergency healthcare workers and the factors influencing burnout in hospital can help in devising methods to recharge the resources and motivation of the workforce and thus the organisation and thereby improve the overall performance of the healthcare system and patient outcomes.

  11. Study protocol : EXERcise and Cognition In Sedentary adults with Early-ONset dementia (EXERCISE-ON)

    NARCIS (Netherlands)

    Hooghiemstra, Astrid M.; Eggermont, Laura H. P.; Scheltens, Philip; van der Flier, Wiesje M.; Bakker, Jet; de Greef, Mathieu H. G.; Koppe, Peter A.; Scherder, Erik J. A.

    2012-01-01

    Background: Although the development of early-onset dementia is a radical and invalidating experience for both patient and family there are hardly any non-pharmacological studies that focus on this group of patients. One type of a non-pharmacological intervention that appears to have a beneficial ef

  12. Effectiveness of occupational therapy in Parkinson's disease: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Sturkenboom, I.H.W.M.; Graff, M.J.L.; Borm, G.F.; Adang, E.M.M.; Nijhuis-Van der Sanden, M.W.G.; Bloem, B.R.; Munneke, M.

    2013-01-01

    BACKGROUND: Occupational therapists may have an added value in the care of patients with Parkinson's disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to

  13. Extended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol

    NARCIS (Netherlands)

    A.T. Cohen; T.E. Spiro; H.R. Büller; L. Haskell; D. Hu; R. Hull; A. Mebazaa; G. Merli; S. Schellong; A. Spyropoulos; V. Tapson

    2011-01-01

    Patients with acute medical illnesses are at increased risk of venous thromboembolism (VTE), a significant cause of morbidity and mortality. Thromboprophylaxis is recommended in these patients but questions remain regarding the optimal duration of therapy. The aim of this study is to determine wheth

  14. Optimizing Inter-Professional Communications in Surgery: Protocol for a Mixed-Methods Exploratory Study

    OpenAIRE

    Hallet, Julie; Wallace, David; El-Sedfy, Abraham; Hall, Trevor NT; Ahmed, Najma; Bridge, Jennifer; Taggar, Ru; Smith, Andy J.; Nathens, Avery B.; Coburn, Natalie G; Gotlib-Conn, Lesley

    2015-01-01

    Background Effective nurse-physician communication is critical to delivering high quality patient care. Interprofessional communication between surgical nurses and surgeons, often through the use of pagers, is currently characterized by information gaps and interprofessional tensions, both sources of workflow interruption, potential medical error, impaired educational experience, and job satisfaction. Objective This study aims to define current patterns of, and understand enablers and barrier...

  15. Triggers for an episode of sudden onset low back pain: Study protocol

    NARCIS (Netherlands)

    M. Steffens (Michael); M.L. Ferreira (Manuela L.); C. Maher (Chris); J. Latimer (Jane); B.W. Koes (Bart); F. Blyth (Fiona); P.H. Ferreira (P.)

    2012-01-01

    textabstractBackground: Most research on risk factors for low back pain has focused on long term exposures rather than factors immediately preceding the onset of low back pain. The aim of this study is to quantify the transient increase in risk of a sudden episode of low back pain associated with ac

  16. WIC Infant and Toddler Feeding Practices Study: protocol design and implementation.

    Science.gov (United States)

    Harrison, Gail G; Hirschman, Jay D; Owens, Tameka A; McNutt, Suzanne W; Sallack, Linnea E

    2014-03-01

    The federal Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), which began in the 1970s, has undergone revisions in the past several years, including revision to contents of the supplemental food "packages" in 2009 based on recommendations provided by an Institute of Medicine (IOM) committee of The National Academies. In 2010, the IOM held a workshop to examine and recommend research priorities for the program. The overall purpose of the current (ie, second) WIC Infant and Toddler Feeding Practices Study (ITFPS-2) is to conduct a nationally representative, longitudinal study of contemporary WIC infant and toddler feeding practices. This study will update earlier studies and collect information on variations in WIC program components. The study will also assess ways in which WIC may address obesity in early childhood and examine changes in feeding practices that may stem from the 2009 food package revisions. The sample is drawn from the universe of WIC sites nationally, excluding only those with an insufficient volume of eligible participants. Eligibility for the study includes the ability to be interviewed in English or Spanish. Approximately 8000 women and infants are being sampled, and ∼ 4000 are expected to participate. Eligible women are invited to participate during their WIC enrollment visit, and informed consent is sought. The design includes a core sample to be followed until the infant reaches age 2 y and a supplemental sample to be used in some cross-sectional analyses to ensure adequate representation of groups that might be underrepresented in the core sample. Participants will complete up to 11 interviews (core sample) or 4 interviews (supplemental sample) each except for the prenatal interview, which includes a quantitative 24-h recall of food intake for the infant. Eighty sites have been sampled across 26 states and 1 territory. Instruments have been developed and pretested in both English and Spanish, and interviewers

  17. Study protocol of a Dutch smoking cessation e-health program

    Directory of Open Access Journals (Sweden)

    Bolman Catherine

    2011-11-01

    Full Text Available Abstract Background The study aims to test the differential effects of a web-based text and a web-based video-driven computer-tailored approach for lower socio-economic status (LSES and higher socio-economic status (HSES smokers which incorporate multiple computer-tailored feedback moments. The two programs differ only in the mode of delivery (video- versus text-based messages. The paper aims to describe the development and design of the two computer-tailored programs. Methods/design Respondents who smoked at the time of the study inclusion, who were motivated to quit within the following six months and who were aged 18 or older were included in the program. The study is a randomized control trial with a 2 (video/text * 2(LSES/HSES design. Respondents were assigned either to one of the intervention groups (text versus video tailored feedback or to the control group (non-tailored generic advice. In all three conditions participants were asked to fill in the baseline questionnaire based on the I-Change model. The questionnaire assessed socio-demographics, attitude towards smoking, knowledge, self-efficacy, social influence, depression, level of addiction, action planning, goal actions, intention to quit smoking, seven-day point prevalence and continued abstinence. Follow-up measurements were conducted at six and twelve months after baseline. Discussion The present paper describes the development of the two computer-tailored smoking cessation programs, their components and the design of the study. The study results reveal different working mechanisms of multiple tailored smoking cessation interventions and will help us to gain more insight into effective strategies to target different subgroups, especially smokers with a lower socio-economic status. Trial registration Dutch Trial Register NTR3102

  18. Influence of societal and practice contexts on health professionals’ clinical reasoning: a scoping study protocol

    Science.gov (United States)

    Carrier, Annie; Levasseur, Mélanie; Freeman, Andrew; Mullins, Gary; Quénec'hdu, Suzanne; Lalonde, Louise; Gagnon, Michaël; Lacasse, Francis

    2013-01-01

    Introduction In a context of constrained resources, the efficacy of interventions is a pivotal aim of healthcare systems worldwide. Efficacy of healthcare interventions is highly compromised if clinical reasoning (CR), the process that practitioners use to plan, direct, perform and reflect on client care, is not optimal. The CR process of health professionals is influenced by the institutional dimension (ie, legal, regulatory, administrative and organisational aspects) of their societal and practice contexts. Although several studies have been conducted with respect to the institutional dimension influencing health professionals’ CR, no clear integration of their results is yet available. The aim of this study is to synthesise and disseminate current knowledge on the influence of the institutional dimension of contexts on health professionals’ CR. Methods and analysis A scoping study of the scientific literature from January 1980 to March 2013 will be undertaken to summarise and disseminate research findings about the influence of the institutional dimension on CR. Numerous databases (n=18) from three relevant fields (healthcare, health law and politics and management) will be searched. Extended search strategies will include the manual search of bibliographies, health-related websites, public registries and journals of interest. Data will be collected and analysed using a thematic chart and content analysis. A systematic multidisciplinary team approach will allow optimal identification of relevant studies, as well as effective and valid content analysis and dissemination of the results. Discussion This scoping study will provide a rigorous, accurate and up-to-date synthesis of existing knowledge regarding: (1) those aspects of the institutional dimension of health professionals’ societal and practice contexts that impact their CR and (2) how these aspects influence health professionals’ CR. Through the synergy of a multidisciplinary research team from a

  19. The world health organization multicountry survey on maternal and newborn health: study protocol

    Directory of Open Access Journals (Sweden)

    Souza João

    2011-10-01

    Full Text Available Abstract Background Effective interventions to reduce mortality and morbidity in maternal and newborn health already exist. Information about quality and performance of care and the use of critical interventions are useful for shaping improvements in health care and strengthening the contribution of health systems towards the Millennium Development Goals 4 and 5. The near-miss concept and the criterion-based clinical audit are proposed as useful approaches for obtaining such information in maternal and newborn health care. This paper presents the methods of the World Health Organization Multicountry Study in Maternal and Newborn Health. The main objectives of this study are to determine the prevalence of maternal near-miss cases in a worldwide network of health facilities, evaluate the quality of care using the maternal near-miss concept and the criterion-based clinical audit, and develop the near-miss concept in neonatal health. Methods/Design This is a large cross-sectional study being implemented in a worldwide network of health facilities. A total of 370 health facilities from 29 countries will take part in this study and produce nearly 275,000 observations. All women giving birth, all maternal near-miss cases regardless of the gestational age and delivery status and all maternal deaths during the study period comprise the study population. In each health facility, medical records of all eligible women will be reviewed during a data collection period that ranges from two to three months according to the annual number of deliveries. Discussion Implementing the systematic identification of near-miss cases, mapping the use of critical evidence-based interventions and analysing the corresponding indicators are just the initial steps for using the maternal near-miss concept as a tool to improve maternal and newborn health. The findings of projects using approaches similar to those described in this manuscript will be a good starter for a more

  20. Study Protocol: Screening and Treatment of Alcohol-Related Trauma (START) – a randomised controlled trial

    OpenAIRE

    Jayaraj Rama; Thomas Mahiban; Kavanagh David; d’Abbs Peter; Mayo Luke; Thomson Valerie; Griffin Carolyn; Nagel Tricia

    2012-01-01

    Abstract Background The incidence of mandibular fractures in the Northern Territory of Australia is very high, especially among Indigenous people. Alcohol intoxication is implicated in the majority of facial injuries, and substance use is therefore an important target for secondary prevention. The current study tests the efficacy of a brief therapy, Motivational Care Planning, in improving wellbeing and substance misuse in youth and adults hospitalised with alcohol-related facial trauma. Meth...

  1. Optimizing diffusion of an online computer tailored lifestyle program: a study protocol

    Directory of Open Access Journals (Sweden)

    Schulz Daniela N

    2011-06-01

    Full Text Available Abstract Background Although the Internet is a promising medium to offer lifestyle interventions to large amounts of people at relatively low costs and effort, actual exposure rates of these interventions fail to meet the high expectations. Since public health impact of interventions is determined by intervention efficacy and level of exposure to the intervention, it is imperative to put effort in optimal dissemination. The present project attempts to optimize the dissemination process of a new online computer tailored generic lifestyle program by carefully studying the adoption process and developing a strategy to achieve sustained use of the program. Methods/Design A prospective study will be conducted to yield relevant information concerning the adoption process by studying the level of adoption of the program, determinants involved in adoption and characteristics of adopters and non-adopters as well as satisfied and unsatisfied users. Furthermore, a randomized control trial will be conducted to the test the effectiveness of a proactive strategy using periodic e-mail prompts in optimizing sustained use of the new program. Discussion Closely mapping the adoption process will gain insight in characteristics of adopters and non-adopters and satisfied and unsatisfied users. This insight can be used to further optimize the program by making it more suitable for a wider range of users, or to develop adjusted interventions to attract subgroups of users that are not reached or satisfied with the initial intervention. Furthermore, by studying the effect of a proactive strategy using period prompts compared to a reactive strategy to stimulate sustained use of the intervention and, possibly, behaviour change, specific recommendations on the use and the application of prompts in online lifestyle interventions can be developed. Trial registration Dutch Trial Register NTR1786 and Medical Ethics Committee of Maastricht University and the University Hospital

  2. Study protocol: Home-based physical rehabilitation for survivors of a critical illness [ACTRN12605000166673

    OpenAIRE

    Elliott, Doug; McKinley, Sharon; Alison, Jennifer A.; Aitken, Leanne M; King, Madeleine T

    2006-01-01

    Introduction Numerous primary studies and several review papers have highlighted delayed physical and psychological recovery for survivors of critical illness, often beyond 6 months after discharge. This randomized controlled trial with blinded assessment aims to test the effects of an 8-week, home-based, individually tailored physical rehabilitation programme on physical and psychological recovery for survivors of a critical illness after discharge from hospital. Method Participants are surv...

  3. General Practitioner Antimicrobial Stewardship Programme Study (GAPS): protocol for a cluster randomised controlled trial

    OpenAIRE

    Avent, Minyon L.; Hansen, Malene Plejdrup; Gilks, Charles; Del Mar, Chris; Halton, Kate; Sidjabat, Hanna; Hall, Lisa; Dobson, Annette; Paterson, David L.; van Driel, Mieke L.

    2016-01-01

    Background There is a strong link between antibiotic consumption and the rate of antibiotic resistance. In Australia, the vast majority of antibiotics are prescribed by general practitioners, and the most common indication is for acute respiratory infections. The aim of this study is to assess if implementing a package of integrated, multifaceted interventions reduces antibiotic prescribing for acute respiratory infections in general practice. Methods/design This is a cluster randomised trial...

  4. Default options in advance directives: study protocol for a randomised clinical trial

    OpenAIRE

    Gabler, Nicole B.; Cooney, Elizabeth; Small, Dylan S.; Troxel, Andrea B.; Arnold, Robert M.; White, Douglas B.; Angus, Derek C.; Loewenstein, George; Volpp, Kevin G; Bryce, Cindy L.; Halpern, Scott D.

    2016-01-01

    Introduction Although most seriously ill Americans wish to avoid burdensome and aggressive care at the end of life, such care is often provided unless patients or family members specifically request otherwise. Advance directives (ADs) were created to provide opportunities to set limits on aggressive care near life's end. This study tests the hypothesis that redesigning ADs such that comfort-oriented care is provided as the default, rather than requiring patients to actively choose it, will pr...

  5. Impact of treatment of ADHD on intimate partner violence (ITAP), a study protocol

    OpenAIRE

    Buitelaar, Nannet JL; Posthumus, Jocelyne A.; Scholing, Agnes; Buitelaar, Jan K

    2014-01-01

    Background Attention-Deficit/Hyperactivity Disorder (ADHD) in adults is one of the predictive and treatable risk factors for delinquency, including intimate partner violence (IPV). Effective treatment of IPV needs to address personal dynamic risk factors, offender typology, and dynamics of the domestic violence. It is unknown whether treatment of ADHD symptoms contributes to a decrease in IPV. The ITAP study aims to investigate the relationship between treatment of ADHD symptoms and IPV in pa...

  6. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    Nichol, Alistair

    2015-02-08

    Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.

  7. A Protocol for the Longitudinal Study of Psychological Resilience in the Australian Defence Force

    OpenAIRE

    Monique F. Crane; Virginia Lewis; Andrew Cohn; Hodson, Stephanie E.; Ruth Parslow; Bryant, Richard A; Cate Chesney; David Forbes

    2012-01-01

    In the last two decades there has been increasing attention directed at the analysis of psychological resilience. The number of modern-day veterans returning from Iraq and Afghanistan has sparked great interest in identifying mechanisms that can either erode or facilitate psychological resilience. In November 2009, the Australian Defence Force (ADF) in collaboration with the Australian Centre for Post-traumatic Mental Health (ACPMH) launched a longitudinal study of psychological resilience du...

  8. Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial

    OpenAIRE

    Sturkenboom, I.H.W.M.; Graff, M.J.L.; Borm, G.F.; Adang, E.M.M.; Nijhuis-Van der Sanden, M.W.G.; Bloem, B R.; Munneke, M.

    2013-01-01

    BACKGROUND: Occupational therapists may have an added value in the care of patients with Parkinson's disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson's disease. METHODS/DESIGN: A multicenter, assessor-blinded, two-armed randomized...

  9. Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol

    OpenAIRE

    Magaji Bello; Moy Foong; Roslani April; Sagap Ismail; Zakaria Jasiah; Blazeby Jane M; Law Chee

    2012-01-01

    Abstract Background Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for R...

  10. Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol

    Directory of Open Access Journals (Sweden)

    Magaji Bello

    2012-09-01

    Full Text Available Abstract Background Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. Methods/design This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil, then administered, scored and analyzed following the developers’ guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. Conclusion The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments

  11. Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial

    OpenAIRE

    Achey, Meredith A; Beck, Christopher A.; Beran, Denise B.; Boyd, Cynthia M.; Schmidt, Peter N; Allison W Willis; Riggare, Sara S.; Simone, Richard B.; Biglan, Kevin M.; Dorsey, E. Ray

    2014-01-01

    Background Interest in improving care for the growing number of individuals with chronic conditions is rising. However, access to care is limited by distance, disability, and distribution of doctors. Small-scale studies in Parkinson disease, a prototypical chronic condition, have suggested that delivering care using video house calls is feasible, offers similar clinical outcomes to in-person care, and reduces travel burden. Methods/Design We are conducting a randomized comparative effectivene...

  12. Effectiveness of a medication-adherence tool: study protocol for a randomized controlled trial

    OpenAIRE

    Hilbink, Mirrian; Lacroix, Joyca; Bremer - van der Heiden, Linda; Van Halteren, Aart; Teichert, Martina; van Lieshout, Jan

    2016-01-01

    Background Research shows that more than half of the people taking medication for a chronic condition are non-adherent. Nonadherence hinders disease control with a burden on patient quality of life and healthcare systems. We developed a tool that provides insight into nonadherence risks and barriers for medication-adherence including an intervention strategy to overcome those barriers. This study aims to assess the effectiveness of using this adherence tool in starters with cardiovascular or ...

  13. The ANIBES Study on Energy Balance in Spain: Design, Protocol and Methodology

    OpenAIRE

    Emma Ruiz; José Manuel Ávila; Adrián Castillo; Teresa Valero; Susana del Pozo; Paula Rodriguez; Javier Aranceta Bartrina; Ángel Gil; Marcela González-Gross; Ortega, Rosa M.; Lluis Serra-Majem; Gregorio Varela-Moreiras

    2015-01-01

    Energy Balance (EB) is an important topic to understand how an imbalance in its main determinants (energy intake and consumption) may lead to inappropriate weight gain, considered to be “dynamic” and not “static”. There are no studies to evaluate EB in Spain, and new technologies reveal themselves as key tools to solve common problems to precisely quantify energy consumption and expenditure at population level. The overall purpose of the ANIBES (“Anthropometry, Intake and Energy Balance”) Stu...

  14. Educating for health service reform: clinical learning, governance and capability – a case study protocol

    OpenAIRE

    Gardner, Anne; Gardner, Glenn; Coyer, Fiona; Gosby, Helen

    2016-01-01

    Background The nurse practitioner is a growing clinical role in Australia and internationally, with an expanded scope of practice including prescribing, referring and diagnosing. However, key gaps exist in nurse practitioner education regarding governance of specialty clinical learning and teaching. Specifically, there is no internationally accepted framework against which to measure the quality of clinical learning and teaching for advanced specialty practice. Methods A case study design wil...

  15. The ANIBES Study on Energy Balance in Spain: Design, Protocol and Methodology

    Directory of Open Access Journals (Sweden)

    Emma Ruiz

    2015-02-01

    Full Text Available Energy Balance (EB is an important topic to understand how an imbalance in its main determinants (energy intake and consumption may lead to inappropriate weight gain, considered to be “dynamic” and not “static”. There are no studies to evaluate EB in Spain, and new technologies reveal themselves as key tools to solve common problems to precisely quantify energy consumption and expenditure at population level. The overall purpose of the ANIBES (“Anthropometry, Intake and Energy Balance” Study was to carry out an accurate updating of food and beverage intake, dietary habits/behaviour and anthropometric data of the Spanish population (9–75 years, n = 2009, as well as the energy expenditure and physical activity patterns. Anthropometry measurements (weight, height, body mass index, waist circumference, % body fat, % body water were obtained; diet was evaluated throughout a three-day dietary record (tablet device accompanied by a 24 h-dietary recall; physical activity was quantified by questionnaire and accelerometers were also employed. Finally, information about perception and understanding of several issues related to EB was also obtained. The ANIBES study will contribute to provide valuable useful data to inform food policy planning, food based dietary guidelines development and other health oriented actions in Spain.

  16. Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol

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    Hagen Sander M

    2011-12-01

    Full Text Available Abstract Background Peritoneal dialysis (PD is an effective treatment for end-stage renal disease. It allows patients more freedom to perform daily activities compared to haemodialysis. Key to successful PD is the presence of a well-functioning dialysis catheter. Several complications, such as in- and outflow obstruction, peritonitis, exit-site infections, leakage and migration, can lead to catheter removal and loss of peritoneal access. Currently, different surgical techniques are in practice for PD-catheter placement. The type of insertion technique used may greatly influence the occurrence of complications. In the literature, up to 35% catheter failure has been described when using the open technique and only 13% for the laparoscopic technique. However, a well-designed randomized controlled trial is lacking. Methods/Design The LOCI-trial is a multi-center randomized controlled, single-blind trial (pilot. The study compares the laparoscopic with the open technique for PD catheter insertion. The primary objective is to determine the optimum placement technique in order to minimize the incidence of catheter malfunction at 6 weeks postoperatively. Secondary objectives are to determine the best approach to optimize catheter function and to study the quality of life at 6 months postoperatively comparing the two operative techniques. Discussion This study will generate evidence on any benefits of laparoscopic versus open PD catheter insertion. Trial registration Dutch Trial Register NTR2878

  17. The effect of a cadence retraining protocol on running biomechanics and efficiency: a pilot study.

    Science.gov (United States)

    Hafer, Jocelyn F; Brown, Allison M; deMille, Polly; Hillstrom, Howard J; Garber, Carol Ewing

    2015-01-01

    Many studies have documented the association between mechanical deviations from normal and the presence or risk of injury. Some runners attempt to change mechanics by increasing running cadence. Previous work documented that increasing running cadence reduces deviations in mechanics tied to injury. The long-term effect of a cadence retraining intervention on running mechanics and energy expenditure is unknown. This study aimed to determine if increasing running cadence by 10% decreases running efficiency and changes kinematics and kinetics to make them less similar to those associated with injury. Additionally, this study aimed to determine if, after 6 weeks of cadence retraining, there would be carryover in kinematic and kinetic changes from an increased cadence state to a runner's preferred running cadence without decreased running efficiency. We measured oxygen uptake, kinematic and kinetic data on six uninjured participants before and after a 6-week intervention. Increasing cadence did not result in decreased running efficiency but did result in decreases in stride length, hip adduction angle and hip abductor moment. Carryover was observed in runners' post-intervention preferred running form as decreased hip adduction angle and vertical loading rate. PMID:25369525

  18. A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: Study protocol (NCT00362193

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    Davis Dianne

    2006-10-01

    Full Text Available Abstract Background Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. Objective This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. Methods The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive, routine care with phone contact every three months (moderate intensity or routine care with phone contact every month (most intensive. Conclusion The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.

  19. A protocol and pilot study for managing fibromyalgia with yoga and meditation.

    Science.gov (United States)

    Hennard, Janet

    2011-01-01

    Fibromyalgia is a chronic syndrome characterized by widespread pain, sleep disturbance, stiffness, fatigue, headache, and mood disorders. Recent research has resulted in an improved understanding of fibromyalgia and its possible causes. This article highlights some of the current research, discusses a strategy for using yoga and meditation as a therapy for fibromyalgia sufferers, and presents the results of a preliminary 8-week study using yoga and meditation to help manage fibromyalgia symptoms. The study of 11 participants found significant improvement in the overall health status of the participants and in symptoms of stiffness, anxiety, and depression. Significant improvements were also seen in the reported number of days "felt good" and number of days "missed work" because of fibromyalgia. Nonsignificant improvements were seen in measures of pain, fatigue, and how one felt in the morning. Effect sizes were medium to large for most tested areas. This study supports the benefits of yoga and meditation for individuals with fibromyalgia and encourages further research to explore their use as standard therapies for fibromyalgia.

  20. The EMBARC European Bronchiectasis Registry: protocol for an international observational study

    Science.gov (United States)

    Aliberti, Stefano; Polverino, Eva; Vendrell, Montserrat; Crichton, Megan; Loebinger, Michael; Dimakou, Katerina; Clifton, Ian; van der Eerden, Menno; Rohde, Gernot; Murris-Espin, Marlene; Masefield, Sarah; Gerada, Eleanor; Shteinberg, Michal; Ringshausen, Felix; Haworth, Charles; Boersma, Wim; Rademacher, Jessica; Hill, Adam T.; Aksamit, Timothy; O'Donnell, Anne; Morgan, Lucy; Milenkovic, Branislava; Tramma, Leandro; Neves, Joao; Menendez, Rosario; Paggiaro, Perluigi; Botnaru, Victor; Skrgat, Sabina; Wilson, Robert; Goeminne, Pieter; De Soyza, Anthony; Welte, Tobias; Torres, Antoni; Elborn, J. Stuart; Blasi, Francesco

    2016-01-01

    Bronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies. The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration) registry is a prospective, pan-European observational study of patients with bronchiectasis. The inclusion criterion is a primary clinical diagnosis of bronchiectasis consisting of: 1) a clinical history consistent with bronchiectasis; and 2) computed tomography demonstrating bronchiectasis. Core exclusion criteria are: 1) bronchiectasis due to known cystic fibrosis; 2) age <18 years; and 3) patients who are unable or unwilling to provide informed consent. The study aims to enrol 1000 patients by April 2016 across at least 20 European countries, and 10 000 patients by March 2020. Patients will undergo a comprehensive baseline assessment and will be followed up annually for up to 5 years with the goal of providing high-quality longitudinal data on outcomes, treatment patterns and quality of life. Data from the registry will be available in the form of annual reports. and will be disseminated in conference presentations and peer-reviewed publications. The European Bronchiectasis Registry aims to make a major contribution to understanding the natural history of the disease, as well as guiding evidence-based decision making and facilitating large randomised controlled trials. PMID:27730179

  1. Triggers for an episode of sudden onset low back pain: study protocol

    Directory of Open Access Journals (Sweden)

    Steffens Daniel

    2012-01-01

    Full Text Available Abstract Background Most research on risk factors for low back pain has focused on long term exposures rather than factors immediately preceding the onset of low back pain. The aim of this study is to quantify the transient increase in risk of a sudden episode of low back pain associated with acute exposure to a range of common physical and psychological factors. Methods/design This study uses a case-crossover design. One thousand adults with a sudden onset of low back pain presenting to primary care clinicians will be recruited. Basic demographic and clinical information including exposure to putative triggers will be collected using a questionnaire. These triggers include exposure to hazardous manual tasks, physical activity, a slip/trip or fall, consumption of alcohol, sexual activity, being distracted, and being fatigued or tired. Exposures in the case window (0-2 hours from the time when participants first notice their back pain will be compared to exposures in two control time-windows (one 24-26 hours and another 48-50 hours before the case window. Discussion The completion of this study will provide the first-research based estimates of the increase in risk of a sudden episode of acute low back pain associated with transient exposure to a range of common factors thought to trigger low back pain.

  2. Interprofessional collaborative practice within cancer teams: Translating evidence into action. A mixed methods study protocol

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    Roberge Danièle

    2010-07-01

    Full Text Available Abstract Background A regional integrated cancer network has implemented a program (educational workshops, reflective and mentoring activities designed to support the uptake of evidence-informed interprofessional collaborative practices (referred to in this text as EIPCP within cancer teams. This research project, which relates to the Registered Nurses' Association of Ontario (RNAO Best Practice Guidelines and other sources of research evidence, represents a unique opportunity to learn more about the factors and processes involved in the translation of evidence-based recommendations into professional practices. The planned study seeks to address context-specific challenges and the concerns of nurses and other stakeholders regarding the uptake of evidence-based recommendations to effectively promote and support interprofessional collaborative practices. Aim This study aims to examine the uptake of evidence-based recommendations from best practice guidelines intended to enhance interprofessional collaborative practices within cancer teams. Design The planned study constitutes a practical trial, defined as a trial designed to provide comprehensive information that is grounded in real-world healthcare dynamics. An exploratory mixed methods study design will be used. It will involve collecting quantitative data to assess professionals' knowledge and attitudes, as well as practice environment factors associated with effective uptake of evidence-based recommendations. Semi-structured interviews will be conducted concurrently with care providers to gather qualitative data for describing the processes involved in the translation of evidence into action from both the users' (n = 12 and providers' (n = 24 perspectives. The Graham et al. Ottawa Model of Research Use will serve to construct operational definitions of concepts, and to establish the initial coding labels to be used in the thematic analysis of the qualitative data. Quantitative and qualitative

  3. A conceptual framework for interprofessional shared decision making in home care: Protocol for a feasibility study

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    Murray Mary-Anne

    2011-01-01

    Full Text Available Abstract Background Shared decision making (SDM is fundamental to informed consent and client-centered care. So far, SDM frameworks have been limited to the client-physician dyad, even though care is increasingly delivered by interprofessional (IP teams. IP collaboration is especially essential in home care, one of health care's most rapidly growing areas. This study will assess whether it is possible to practice SDM in IP home care. Methods/Design We will use a qualitative case study and a quantitative survey to capture the macro, meso and micro levels of stakeholders in home care. The case study will follow the knowledge-to-action process framework to evaluate the work of an IP home care team at a Quebec City health center. Sources of data will include one-on-one interviews with patients, family caregivers or surrogates and significant others, and administrators; a focus group of home care health professionals; organizational documents; and government policies and standards. The interview guide for the interviews and the focus group will explore current practices and clinical problems addressed in home care; factors that could influence the implementation of the proposed IP approach to SDM; the face and content validity of the approach; and interventions to facilitate the implementation and evaluation of the approach. The survey will ask 300 health professionals working in home care at the health center to complete a questionnaire based on the Theory of Planned Behaviour that measures their intentions to engage in an IP approach to SDM. We will use our analysis of the individual interviews, the focus group and the survey to elaborate a toolkit for implementing an IP approach to SDM in home care. Finally, we will conduct a pilot study in Alberta to assess the transferability of our findings. Discussion We believe that developing tools to implement IP SDM in home care is essential to strengthening Canada's healthcare system and furthering

  4. Disseminating quality improvement: study protocol for a large cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    French Michael T

    2011-04-01

    Full Text Available Abstract Background Dissemination is a critical facet of implementing quality improvement in organizations. As a field, addiction treatment has produced effective interventions but disseminated them slowly and reached only a fraction of people needing treatment. This study investigates four methods of disseminating quality improvement (QI to addiction treatment programs in the U.S. It is, to our knowledge, the largest study of organizational change ever conducted in healthcare. The trial seeks to determine the most cost-effective method of disseminating quality improvement in addiction treatment. Methods The study is evaluating the costs and effectiveness of different QI approaches by randomizing 201 addiction-treatment programs to four interventions. Each intervention used a web-based learning kit plus monthly phone calls, coaching, face-to-face meetings, or the combination of all three. Effectiveness is defined as reducing waiting time (days between first contact and treatment, increasing program admissions, and increasing continuation in treatment. Opportunity costs will be estimated for the resources associated with providing the services. Outcomes The study has three primary outcomes: waiting time, annual program admissions, and continuation in treatment. Secondary outcomes include: voluntary employee turnover, treatment completion, and operating margin. We are also seeking to understand the role of mediators, moderators, and other factors related to an organization's success in making changes. Analysis We are fitting a mixed-effect regression model to each program's average monthly waiting time and continuation rates (based on aggregated client records, including terms to isolate state and intervention effects. Admissions to treatment are aggregated to a yearly level to compensate for seasonality. We will order the interventions by cost to compare them pair-wise to the lowest cost intervention (monthly phone calls. All randomized sites

  5. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

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    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

  6. Low-dose human chorionic gonadotropin adjunct to an antagonist protocol in assisted reproductive technology: a randomized trial study.

    Directory of Open Access Journals (Sweden)

    Marzieh Aghahosseini

    2014-06-01

    Full Text Available The aim of this study was to evaluate the outcomes of adding low-dose hCG (human chorionic gonadotropin, as an LH active supplement, to a GnRH antagonist protocol in patients undergoing assisted reproduction techniques. In this parallel-group randomized clinical trial, 137 infertile female outpatients aged 20 - 39 years were randomized into two groups: hCG group and non-hCG group. All patients received r-FSH (150-300 IU and then a GnRH-antagonist, Cetrorelix (0.25 mg/day. Concomitantly with Cetrorelix, patients in the hCG group received low-dose hCG (200 IU daily, but the patients in the non-hCG group did not. 10,000 IU Urinary hCG (10,000 IU was injected to all patients, and ICSI was performed after oocyte retrieval. The primary outcome of this study was comparing the pregnancy rates between two study groups. Other differences between two groups such as serum estradiol concentration, fertilization rate, etc. were considered as secondary outcomes. A total of 130 patients completed this trial. No significant difference was detected between pregnancy rates of the two groups (P=0.52 as well as the fertilization, implantation and ongoing pregnancy rates (P=0.11, P=0.75 and P=0.06 respectively. The only significant difference between two groups was a higher concentration of estradiol in the hCG-treated patients (P<0.05. HCG-treated patients experienced a shorter treatment duration and a lower r-FSH required dose than the non-hCG group, but none of these differences were statistically significant (P=0.19 and P=0.10, respectively. The findings of the current study did not support advantages of adding low-dose hCG to GnRH antagonist plus r-FSH protocol in an unselected population of patients. Well-designed trials with a larger sample size for specific patients' subgroups are warranted.

  7. Intravenous immunoglobulin in the treatment of primary trigeminal neuralgia refractory to carbamazepine: a study protocol[ISRCTN33042138

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    Roewer Norbert

    2003-01-01

    Full Text Available Abstract Background We have recently reported successful treatment of patients with chronic pain syndromes using human pooled intravenous immunoglobulin (IVIG in a prospective, open-label cohort study. A randomised, placebo controlled, double blinded study is needed to confirm these results. We chose to study patients with carbamazepine resistant primary Trigeminal Neuralgia (rpTN, as these had responded particularly well to IVIG. A protocol involving the use of IVIG in rpTN is complex for three reasons: 1. The effect of IVIG does not follow simple dose-response rules; 2. The response pattern of patients to IVIG was variable and ranged between no effect at all and pain free remission between two weeks and >1 year; 3. TN is characterized by extremely severe pain, for which operative intervention is (if temporarily helpful in most patients. Design A placebo controlled, parallel, add-on model was developed and the primary outcome variable defined as the length of time during which patients remain in the study. Study groups are compared using Kaplan-Maier survival analysis. Patients record their response to treatment ("severe, moderate, slight, no pain". The study coordinator monitors pain diaries. Severe or moderate pain of three days duration will result in termination of the study for that patient. Conclusions This study design utilizes a method of survival analysis and is novel in chronic pain research. It allows for both early departure from the study and voluntary crossover upon non-response. It may be applicable to the analysis of IVIG efficacy in other chronic pain syndromes.

  8. Safety in home care: A research protocol for studying medication management

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    Easty Anthony

    2010-06-01

    Full Text Available Abstract Background Patient safety is an ongoing global priority, with medication safety considered a prevalent, high-risk area of concern. Yet, we have little understanding of the supports and barriers to safe medication management in the Canadian home care environment. There is a clear need to engage the providers and recipients of care in studying and improving medication safety with collaborative approaches to exploring the nature and safety of medication management in home care. Methods A socio-ecological perspective on health and health systems drives our iterative qualitative study on medication safety with elderly home care clients, family members and other informal caregivers, and home care providers. As we purposively sample across four Canadian provinces: Alberta (AB, Ontario (ON, Quebec (QC and Nova Scotia (NS, we will collect textual and visual data through home-based interviews, participant-led photo walkabouts of the home, and photo elicitation sessions at clients' kitchen tables. Using successive rounds of interpretive description and human factors engineering analyses, we will generate robust descriptions of managing medication at home within each provincial sample and across the four-province group. We will validate our initial interpretations through photo elicitation focus groups with home care providers in each province to develop a refined description of the phenomenon that can inform future decision-making, quality improvement efforts, and research. Discussion The application of interpretive and human factors lenses to the visual and textual data is expected to yield findings that advance our understanding of the issues, challenges, and risk-mitigating strategies related to medication safety in home care. The images are powerful knowledge translation tools for sharing what we learn with participants, decision makers, other healthcare audiences, and the public. In addition, participants engage in knowledge exchange

  9. Multi-level analysis of electronic health record adoption by health care professionals: A study protocol

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    Labrecque Michel

    2010-04-01

    Full Text Available Abstract Background The electronic health record (EHR is an important application of information and communication technologies to the healthcare sector. EHR implementation is expected to produce benefits for patients, professionals, organisations, and the population as a whole. These benefits cannot be achieved without the adoption of EHR by healthcare professionals. Nevertheless, the influence of individual and organisational factors in determining EHR adoption is still unclear. This study aims to assess the unique contribution of individual and organisational factors on EHR adoption in healthcare settings, as well as possible interrelations between these factors. Methods A prospective study will be conducted. A stratified random sampling method will be used to select 50 healthcare organisations in the Quebec City Health Region (Canada. At the individual level, a sample of 15 to 30 health professionals will be chosen within each organisation depending on its size. A semi-structured questionnaire will be administered to two key informants in each organisation to collect organisational data. A composite adoption score of EHR adoption will be developed based on a Delphi process and will be used as the outcome variable. Twelve to eighteen months after the first contact, depending on the pace of EHR implementation, key informants and clinicians will be contacted once again to monitor the evolution of EHR adoption. A multilevel regression model will be applied to identify the organisational and individual determinants of EHR adoption in clinical settings. Alternative analytical models would be applied if necessary. Results The study will assess the contribution of organisational and individual factors, as well as their interactions, to the implementation of EHR in clinical settings. Conclusions These results will be very relevant for decision makers and managers who are facing the challenge of implementing EHR in the healthcare system. In addition

  10. Study protocol: optimization of complex palliative care at home via telemedicine. A cluster randomized controlled trial

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    Hasselaar Jeroen

    2011-08-01

    Full Text Available Abstract Background Due to the growing number of elderly with advanced chronic conditions, healthcare services will come under increasing pressure. Teleconsultation is an innovative approach to deliver quality of care for palliative patients at home. Quantitative studies assessing the effect of teleconsultation on clinical outcomes are scarce. The aim of this present study is to investigate the effectiveness of teleconsultation in complex palliative homecare. Methods/Design During a 2-year recruitment period, GPs are invited to participate in this cluster randomized controlled trial. When a GP refers an eligible patient for the study, the GP is randomized to the intervention group or the control group. Patients in the intervention group have a weekly teleconsultation with a nurse practitioner and/or a physician of the palliative consultation team. The nurse practitioner, in cooperation with the palliative care specialist of the palliative consultation team, advises the GP on treatment policy of the patient. The primary outcome of patient symptom burden is assessed at baseline and weekly using the Edmonton Symptom Assessment Scale (ESAS and at baseline and every four weeks using the Hospital Anxiety and Depression Scale (HADS. Secondary outcomes are self-perceived burden from informal care (EDIZ, patient experienced continuity of medical care (NCQ, patient and caregiver satisfaction with the teleconsultation (PSQ, the experienced problems and needs in palliative care (PNPC-sv and the number of hospital admissions. Discussion This is one of the first randomized controlled trials in palliative telecare. Our data will verify whether telemedicine positively affects palliative homecare. Trial registration The Netherlands National Trial Register NTR2817

  11. Improving physician hand hygiene compliance using behavioural theories: a study protocol

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    Squires Janet E

    2013-02-01

    Full Text Available Abstract Background Healthcare-associated infections affect 10% of patients in Canadian acute-care hospitals and are significant and preventable causes of morbidity and mortality among hospitalized patients. Hand hygiene is among the simplest and most effective preventive measures to reduce these infections. However, compliance with hand hygiene among healthcare workers, specifically among physicians, is consistently suboptimal. We aim to first identify the barriers and enablers to physician hand hygiene compliance, and then to develop and pilot a theory-based knowledge translation intervention to increase physicians’ compliance with best hand hygiene practice. Design The study consists of three phases. In Phase 1, we will identify barriers and enablers to hand hygiene compliance by physicians. This will include: key informant interviews with physicians and residents using a structured interview guide, informed by the Theoretical Domains Framework; nonparticipant observation of physician/resident hand hygiene audit sessions; and focus groups with hand hygiene experts. In Phase 2, we will conduct intervention mapping to develop a theory-based knowledge translation intervention to improve physician hand hygiene compliance. Finally, in Phase 3, we will pilot the knowledge translation intervention in four patient care units. Discussion In this study, we will use a behavioural theory approach to obtain a better understanding of the barriers and enablers to physician hand hygiene compliance. This will provide a comprehensive framework on which to develop knowledge translation interventions that may be more successful in improving hand hygiene practice. Upon completion of this study, we will refine the piloted knowledge translation intervention so it can be tested in a multi-site cluster randomized controlled trial.

  12. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

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    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  13. Implementing mentor mothers in family practice to support abused mothers: Study protocol

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    Laurant Miranda GH

    2011-10-01

    Full Text Available Abstract Background Intimate partner violence is highly prevalent and mostly affects women with negative consequences for their physical and mental health. Children often witness the violence which has negative consequences for their well-being too. Care offered by family physicians is often rejected because abused women experience a too high threshold. Mentor mother support, a low threshold intervention for abused mothers in family practice, proved to be feasible and effective in Rotterdam, the Netherlands. The primary aim of this study is to investigate which factors facilitate or hinder the implementation of mentor mother support in family practice. Besides we evaluate the effect of mentor mother support in a different region. Methods/Design An observational study with pre- and posttests will be performed. Mothers with home living children or pregnant women who are victims of intimate partner violence will be offered mentor mother support by the participating family physicians. The implementation process evaluation consists of focus groups, interviews and questionnaires. In the effect evaluation intimate partner violence, the general health of the abused mother, the mother-child relationship, social support, and acceptance of professional help will be measured twice (t = 0 and t = 6 months by questionnaires, reporting forms, medical records and interviews with the abused mothers. Qualitative coding will be used to analyze the data from the reporting forms, medical records, focus groups, interviews, and questionnaires. Quantitative data will be analyzed with descriptive statistics, chi square test and t-test matched pairs. Discussion While other intervention studies only evaluate the feasibility and effectiveness of the intervention, our primary aim is to evaluate the implementation process and thereby investigate which factors facilitate or hinder implementation of mentor mother support in family practice.

  14. The effectiveness of Nurse Practitioners working at a GP cooperative: a study protocol

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    Wijers Nancy

    2012-08-01

    Full Text Available Abstract Background In many countries out-of-hours care faces serious challenges, including shortage of general practitioners, a high workload, reduced motivation to work out of hours, and increased demand for out-of-hours care. One response to these challenges is the introduction of nurse practitioner as doctor substitutes, in order to maintain the (high accessibility and safety of out of hours care. Although nurse practitioners have proven to provide equally safe and efficient care during daytime primary care, it is unclear whether substitution is effective and efficient in the more complex out of hours primary care. This study aims to assess the effects of substitution of care from general practitioners to nurse practitioners in an out of hours primary care setting. Design A quasi experimental study is undertaken at one “general practitioner cooperative” to offer out-of-hours care for 304.000 people in the South East of the Netherlands. In the experimental condition patient care is provided by a team of one nurse practitioner and four general practitioners; where the nurse practitioner replaces one general practitioner during one day of the weekend from 10 am to 5 pm. In the control condition patient care is provided by a team of five general practitioners during the other day of the weekend, also from 10 am to 5 pm. The study period last 15 months, from April 2011 till July 2012. Methods Data will be collected on number of different outcomes using a range of methods. Our primary outcome is substitution of care. This is calculated using the number and characteristics of patients that have a consultation at the GP cooperative. We compare the number of patients seen by both professionals, type of complaints, resource utilization (e.g. prescription, tests, investigations, referrals and waiting times in the experimental condition and control condition. This data is derived from patient electronic medical records. Secondary outcomes

  15. Study and Design an Anycast Routing Protocol for Wireless Sensor Networks

    OpenAIRE

    Demin Gao; Huanyan Qian; Zheng Wang; Jiguang Chen

    2011-01-01

    In wireless sensor networks, there is usually a sink which gathers data from the battery-powered sensor nodes. As sensor nodes around the sink consume their energy faster than the other nodes, several sinks have to be deployed to increase the network lifetime. Anycast is a mechanism that the source node sends the data to the nearest sink node. The paper study and design an anycast service for deploying several sinks in wireless sensor network. A novel anycast tree-based is proposed approach t...

  16. [Comparative study of two protocols of antibiotic prophylaxis in endoscopic urologic surgery].

    Science.gov (United States)

    Lepage, J Y; Malinowsky, J M; Cozian, A; Viers, M F; Rolland, M T; Péron, M; Souron, R; Baron, D

    1990-06-01

    We report an open, prospective, randomized and double-blind study which compared two groups of patients without preoperative bacteriuria, undergoing transurethral urologic surgery. A first group received cefazoline 3 g perioperatively and a second group a single preoperative dose of cefotiam 1 g. A hundred patients were included in each group which were well matched on all essential characteristics, risk factors, surgery, anesthesia and postoperative temperature. The incidence of postoperative infection (bacteriemia and bacteriuria) was the same in both groups (16%). It is concluded that in transurethral urologic surgery performed in patients without preoperative bacteriuria, 1 preoperative dose cefotiam is as efficacious as 3 perioperative doses cefazoline.

  17. Study protocol: EXERcise and Cognition In Sedentary adults with Early-ONset dementia (EXERCISE-ON)

    OpenAIRE

    Hooghiemstra Astrid M; Eggermont Laura HP; Scheltens Philip; van der Flier Wiesje M; Bakker Jet; de Greef Mathieu HG; Koppe Peter A; Scherder Erik JA

    2012-01-01

    Abstract Background Although the development of early-onset dementia is a radical and invalidating experience for both patient and family there are hardly any non-pharmacological studies that focus on this group of patients. One type of a non-pharmacological intervention that appears to have a beneficial effect on cognition in older persons without dementia and older persons at risk for dementia is exercise. In view of their younger age early-onset dementia patients may be well able to partic...

  18. Stimulant Reduction Intervention using Dosed Exercise (STRIDE - CTN 0037: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Morris David W

    2011-09-01

    Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions

  19. Incidence of cardiovascular events after kidney transplantation and cardiovascular risk scores: study protocol

    Directory of Open Access Journals (Sweden)

    Lorenzo-Aguiar Dolores

    2011-01-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the major cause of death after renal transplantation. Not only conventional CVD risk factors, but also transplant-specific risk factors can influence the development of CVD in kidney transplant recipients. The main objective of this study will be to determine the incidence of post-transplant CVD after renal transplantation and related factors. A secondary objective will be to examine the ability of standard cardiovascular risk scores (Framingham, Regicor, SCORE, and DORICA to predict post-transplantation cardiovascular events in renal transplant recipients, and to develop a new score for predicting the risk of CVD after kidney transplantation. Methods/Design Observational prospective cohort study of all kidney transplant recipients in the A Coruña Hospital (Spain in the period 1981-2008 (2059 transplants corresponding to 1794 patients. The variables included will be: donor and recipient characteristics, chronic kidney disease-related risk factors, pre-transplant and post-transplant cardiovascular risk factors, routine biochemistry, and immunosuppressive, antihypertensive and lipid-lowering treatment. The events studied in the follow-up will be: patient and graft survival, acute rejection episodes and cardiovascular events (myocardial infarction, invasive coronary artery therapy, cerebral vascular events, new-onset angina, congestive heart failure, rhythm disturbances and peripheral vascular disease. Four cardiovascular risk scores were calculated at the time of transplantation: the Framingham score, the European Systematic Coronary Risk Evaluation (SCORE equation, and the REGICOR (Registre Gironí del COR (Gerona Heart Registry, and DORICA (Dyslipidemia, Obesity, and Cardiovascular Risk functions. The cumulative incidence of cardiovascular events will be analyzed by competing risk survival methods. The clinical relevance of different variables will be calculated using the ARR (Absolute Risk

  20. Co-Designing Mobile Apps to Assist in Clinical Nursing Education: A Study Protocol.

    Science.gov (United States)

    O'Connor, Siobhan; Andrews, Tom

    2016-01-01

    Mobile applications (apps) to train health professionals is gaining momentum as the benefits of mobile learning (mLearning) are becoming apparent in complex clinical environments. However, most educational apps are generic, off-the-shelf pieces of software that do not take into consideration the unique needs of nursing students. The proposed study will apply a user-centred design process to create a tailored mobile app for nursing students to learn and apply clinical skills in practice. The app will be piloted and evaluated to understand how nursing students use mobile technology in clinical settings to support their learning and educational needs. PMID:27332433

  1. A thorough protocol to study and develop constructive systems of façades

    OpenAIRE

    Vidaurre-Arbizu, M. (Marina); Ramos-Ruiz, G. (Germán); Torres-Ramo, J. (Joaquín); Esteban-Valencia, I. (Iñaki); Gutiérrez-Fernández, M.Á. (Miguel Ángel)

    2010-01-01

    In the Department of Construction Science, we have developed and documented a specific model of systematized process in order to carry out activities of R&D&I oriented to a detailed design of constructive systems of innovative façades. This specific model will be used as a guide for the study, analysis, design and evaluation of the proposed solutions for façades. This model of systematized process of research provides a general idea of the set of stages and activities in the processes of ...

  2. Factors influencing delay in the diagnosis of colorectal cancer: a study protocol

    International Nuclear Information System (INIS)

    Colorectal cancer (CRC) is the second most frequent tumor in developed countries. Since survival from CRC depends mostly on disease stage at the time of diagnosis, individuals with symptoms or signs suspicious of CRC should be examined without delay. Many factors, however, intervene between symptom onset and diagnosis. This study was designed to: 1) Describe the diagnostic process of CRC from the onset of first symptoms to diagnosis and treatment. 2) Establish the time interval from initial symptoms to diagnosis and treatment, globally and considering patient's and doctors' delay, with the latter due to family physician and/or hospital services. 3) Identify the factors related to defined types of delay. 4) Assess the concordance between information included in primary health care and hospital clinical records regarding onset of first symptoms. Descriptive study, coordinated, with 5 participant groups of 5 different Spanish regions (Balearic Islands, Galicia, Catalunya, Aragón and Valencia Health Districts), with a total of 8 acute public hospitals and 140 primary care centers. Incident cases of CRC during the study period, as identified from pathology services at the involved hospitals. A sample size of 896 subjects has been estimated, 150 subjects for each participant group. Information will be collected through patient interviews and primary health care and hospital clinical records. Patient variables will include sociodemographic variables, family history of cancer, symptom perception, and confidence in the family physician; tumor variables will include tumor site, histological type, grade and stage; symptom variables will include date of onset, type and number of symptoms; health system variables will include number of patient contacts with family physician, type and content of the referral, hospital services attending the patient, diagnostic modalities and results; and delay intervals, including global delays and delays attributed to the patient

  3. Advancing Migrant Access to Health Services in Europe (AMASE): Protocol for a Cross-sectional Study

    Science.gov (United States)

    Álvarez-del Arco, Débora; Monge, Susana; Copas, Andrew J; Gennotte, Anne-Francoise; Volny-Anne, Alain; Göpel, Siri; Touloumi, Giota; Prins, Maria; Barros, Henrique; Staehelin, Cornelia; del Amo, Julia; Burns, Fiona M

    2016-01-01

    Background Migrants form a substantial proportion of the population affected by the human immunodeficiency virus (HIV) epidemic in Europe, yet HIV prevention for this population is hindered by poor understanding of access to care and of postmigration transmission dynamics. Objective We present the design and methods of the advancing Migrant Access to health Services in Europe (aMASE) study, the first European cross-cultural study focused on multiple migrant populations. It aims to identify the structural, cultural, and financial barriers to HIV prevention, diagnosis, and treatment and to determine the likely country of HIV acquisition in HIV-positive migrant populations. Methods We delivered 2 cross-sectional electronic surveys across 10 countries (Belgium, France, Germany, Greece, Italy, the Netherlands, Portugal, Spain, Switzerland, and United Kingdom). A clinic survey aimed to recruit up to 2000 HIV-positive patients from 57 HIV clinics in 9 countries. A unique study number linked anonymized questionnaire data to clinical records data (viral loads, CD4 cell counts, viral clades, etc). This questionnaire was developed by expert panel consensus and cognitively tested, and a pilot study was carried out in 2 countries. A Web-based community survey (n=1000) reached those living with HIV but not currently accessing HIV clinics, as well as HIV-negative migrants. It was developed in close collaboration with a community advisory group (CAG) made up of representatives from community organizations in 9 of the participating countries. The CAG played a key role in data collection by promoting the survey to higher-risk migrant groups (sub-Saharan Africans, Latin Americans, men who have sex with men, and people who inject drugs). The questionnaires have considerable content overlap, allowing for comparison. Questions cover ethnicity, migration, immigration status, HIV testing and treatment, health-seeking behavior, sexual risk, and drug use. The electronic questionnaires

  4. Testing a Dutch web-based tailored lifestyle programme among adults: a study protocol

    Directory of Open Access Journals (Sweden)

    van Osch Liesbeth ADM

    2011-02-01

    Full Text Available Abstract Background Smoking, high alcohol consumption, unhealthy eating habits and physical inactivity often lead to (chronic diseases, such as cardiovascular diseases and cancer. Tailored online interventions have been proven to be effective in changing health behaviours. The aim of this study is to test and compare the effectiveness of two different tailoring strategies for changing lifestyle compared to a control group using a multiple health behaviour web-based approach. Methods In our Internet-based tailored programme, the five lifestyle behaviours of smoking, alcohol intake, fruit consumption, vegetable consumption, and physical activity are addressed. This randomized controlled trial, conducted among Dutch adults, includes two experimental groups (i.e., a sequential behaviour tailoring condition and a simultaneous behaviour tailoring condition and a control group. People in the sequential behaviour tailoring condition obtain feedback on whether their lifestyle behaviours meet the Dutch recommendations. Using a step-by-step approach, they are stimulated to continue with a computer tailored module to change only one unhealthy behaviour first. In the course of the study, they can proceed to change a second behaviour. People in the simultaneous behaviour tailoring condition receive computer tailored feedback about all their unhealthy behaviours during their first visit as a stimulation to change all unhealthy behaviours. The experimental groups can re-visit the website and can then receive ipsative feedback (i.e., current scores are compared to previous scores in order to give feedback about potential changes. The (difference in effectiveness of the different versions of the programme will be tested and compared to a control group, in which respondents only receive a short health risk appraisal. Programme evaluations will assess satisfaction with and appreciation and personal relevance of the intervention among the respondents. Finally

  5. How do surgeons decide to refer patients for adjuvant cancer treatment? Protocol for a qualitative study

    Directory of Open Access Journals (Sweden)

    Urquhart Robin

    2012-10-01

    Full Text Available Abstract Background Non-small cell lung cancer, breast cancer, and colorectal cancer are commonly diagnosed cancers in Canada. Patients diagnosed with early-stage non-small cell lung, breast, or colorectal cancer represent potentially curable populations. For these patients, surgery is the primary mode of treatment, with (neoadjuvant therapies (e.g., chemotherapy, radiotherapy recommended according to disease stage. Data from our research in Nova Scotia, as well as others’, demonstrate that a substantial proportion of non-small cell lung cancer and colorectal cancer patients, for whom practice guidelines recommend (neoadjuvant therapy, are not referred for an oncologist consultation. Conversely, surveillance data and clinical experience suggest that breast cancer patients have much higher referral rates. Since surgery is the primary treatment, the surgeon plays a major role in referring patients to oncologists. Thus, an improved understanding of how surgeons make decisions related to oncology services is important to developing strategies to optimize referral rates. Few studies have examined decision making for (neoadjuvant therapy from the perspective of the cancer surgeon. This study will use qualitative methods to examine decision-making processes related to referral to oncology services for individuals diagnosed with potentially curable non-small cell lung, breast, or colorectal cancer. Methods A qualitative study will be conducted, guided by the principles of grounded theory. The study design is informed by our ongoing research, as well as a model of access to health services. The method of data collection will be in-depth, semi structured interviews. We will attempt to recruit all lung, breast, and/or colorectal cancer surgeons in Nova Scotia (n ≈ 42, with the aim of interviewing a minimum of 34 surgeons. Interviews will be audiotaped and transcribed verbatim. Data will be collected and analyzed concurrently, with two investigators

  6. The effectiveness of a health promotion with group intervention by clinical trial. Study protocol

    Directory of Open Access Journals (Sweden)

    Campo Osaba Maria-Antonia

    2012-03-01

    Full Text Available Abstract Background The promotion of health and the interventions in community health continue to be one of the pending subjects of our health system. The most prevalent health problems (cardiovascular diseases, cancer, diabetes... are for the most part related to life habits. We propose a holistic and integral approach as the best option for tackling behavior and its determinants. The research team has elaborated the necessary educational material to realize group teaching, which we call "Health Workshops". The goal of the present study is to evaluate the effectiveness of these Health Workshops in the following terms: Health Related Quality of Life (HRQOL, incorporate and maintain a balanced diet, do physical activity regularly, maintain risk factors such as tension, weight, cholesterol within normal limits and diminish cardiovascular risk. Methods/Design Controlled and random clinical testing, comparing a group of persons who have participated in the Health Workshops with a control group of similar characteristics who have not participated in the Health Workshops. Field of study: the research is being done in Health Centers of the city of Barcelona, Spain. Population studied: The group is composed of 108 persons that are actually doing the Health Workshops, and 108 that are not and form the control group. They are assigned at random to one group or the other. Data Analysis: With Student's t-distribution test to compare the differences between numerical variables or their non parametric equivalent if the variable does not comply with the criteria of normality. (Kolmogorov-Smirnof test. Chi-square test to compare the differences between categorical variables and the Logistic Regression Model to analyze different meaningful variables by dichotomous analysis related to the intervention. Discussion The Health Workshop proposed in the present study constitutes an innovative approach in health promotion, placing the emphasis on the person's self

  7. Study Protocol: Screening and Treatment of Alcohol-Related Trauma (START – a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Jayaraj Rama

    2012-10-01

    Full Text Available Abstract Background The incidence of mandibular fractures in the Northern Territory of Australia is very high, especially among Indigenous people. Alcohol intoxication is implicated in the majority of facial injuries, and substance use is therefore an important target for secondary prevention. The current study tests the efficacy of a brief therapy, Motivational Care Planning, in improving wellbeing and substance misuse in youth and adults hospitalised with alcohol-related facial trauma. Methods and design The study is a randomised controlled trial with 6 months of follow-up, to examine the effectiveness of a brief and culturally adapted intervention in improving outcomes for trauma patients with at-risk drinking admitted to the Royal Darwin Hospital maxillofacial surgery unit. Potential participants are identified using AUDIT-C questionnaire. Eligible participants are randomised to either Motivational Care Planning (MCP or Treatment as Usual (TAU. The outcome measures will include quantity and frequency of alcohol and other substance use by Timeline Followback. The recruitment target is 154 participants, which with 20% dropout, is hoped to provide 124 people receiving treatment and follow-up. Discussion This project introduces screening and brief interventions for high-risk drinkers admitted to the hospital with facial trauma. It introduces a practical approach to integrating brief interventions in the hospital setting, and has potential to demonstrate significant benefits for at-risk drinkers with facial trauma. Trial Registration The trial has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR and Trial Registration: ACTRN12611000135910.

  8. Genetic test feedback with weight control advice: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Meisel Susanne F

    2012-12-01

    Full Text Available Abstract Background Genetic testing for risk of weight gain is already available over the internet despite uncertain benefits and concerns about adverse emotional or behavioral effects. Few studies have assessed the effect of adding genetic test feedback to weight control advice, even though one of the proposed applications of genetic testing is to stimulate preventive action. This study will investigate the motivational effect of adding genetic test feedback to simple weight control advice in a situation where weight gain is relatively common. Methods/design First-year university students (n = 800 will be randomized to receive either 1 their personal genetic test result for a gene (FTO related to weight gain susceptibility in addition to a leaflet with simple weight control advice (‘Feedback + Advice’ group, FA, or 2 only the leaflet containing simple weight control advice (‘Advice Only’ group, AO. Motivation to avoid weight gain and active use of weight control strategies will be assessed one month after receipt of the leaflet with or without genetic test feedback. Weight and body fat will be measured at baseline and eight months follow-up. We will also assess short-term psychological reactions to the genetic test result. In addition, we will explore interactions between feedback condition and gene test status. Discussion We hope to provide a first indication of the clinical utility of weight-related genetic test feedback in the prevention context. Trial registration Current controlled trials ISRCTN91178663

  9. 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

  10. Efficacy and safety of a TIA/stroke electronic support tool (FASTEST trial: Study protocol

    Directory of Open Access Journals (Sweden)

    Ranta Annemarei

    2012-10-01

    Full Text Available Abstract Background Strokes are a common cause of adult disability and mortality worldwide. Transient ischaemic attacks (TIA are associated with a high risk of subsequent stroke, and rapid intervention has the potential to reduce stroke burden. This study will assess a novel electronic decision support (EDS tool to allow general practitioners (GPs to implement evidence-based care rapidly without full reliance on specialists. Methods/design This is a cluster randomized controlled trial comparing TIA/stroke management of GPs with access to the EDS tool versus usual care. The intervention period is 12 months with a 3-month follow-up period for individual patients. Primary outcomes consist of stroke within 90 days of presenting event and adherence to the New Zealand national TIA guideline. Discussion A positive study will provide strong evidence for widespread implementation of this tool in practice and has the potential to improve key outcomes for patients and reduce the burden of stroke. Trial registration Australia New Zealand Clinical Trials Registry ACTRN12611000792921

  11. A comparative study of Sterofundin and Ringer lactate based infusion protocol in scoliosis correction surgery

    Science.gov (United States)

    Sharma, Ashima; Yadav, Monu; Kumar, B. Rajesh; Lakshman, P. Sai; Iyenger, Raju; Ramchandran, Gopinath

    2016-01-01

    Background: A major change in anesthesia practice as regards to intraoperative infusion therapy is the present requirement. Switching over to balanced fluids can substantially decrease the incidence of lactic acidosis and hyperchloremic acidosis. The deleterious effects of unbalanced fluids are more recognizable during major surgeries. We prospectively studied the influence of Sterofundin (SF) and Ringer lactate (RL) on acid–base changes, hemodynamics, and readiness for extubation during scoliosis surgery. Subjects and Methods: Thirty consecutive children posted for scoliosis surgery were randomized to receive either RL (n = 15) or SF (n = 15) as intraoperative fluid at 10 mg/kg/h. Fluid boluses were added according to the study fluid algorithm. Arterial blood was sampled and analyzed at hourly intervals during surgery. Red blood cell transfusion was guided by hematocrit below 27. Patients were followed for 24 h postoperatively in the Intensive Care Unit. Results: There was no statistically significant difference in the volume of infused fluid (2400 ± 512 ml in Group RL and 2200 ± 640 ml in Group SF. There were no significant changes in pH of patients infused with SF. Statistically, significant higher lactate levels were seen in RL-infused group. The strong ion difference was decreased in both groups, but it normalized earlier with SF. Conclusions: SF-infused patients had nonremarkable changes in acid–base physiology in scoliosis surgery. PMID:27746547

  12. Culturally-Tailored Smoking Cessation for American Indians: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Shireman Theresa I

    2011-05-01

    Full Text Available Abstract Background Cigarette smoking is the number one cause of preventable death among American Indian and Alaska Natives, AI/ANs. Two out of every five AI/AN will die from tobacco-related diseases if the current smoking rates of AI/ANs (40.8% persist. Currently, there is no proven, effective culturally-tailored smoking cessation program designed specifically for a heterogeneous population of AI. The primary aim of this group randomized clinical trial is to test the efficacy of "All Nations Breath of Life" (ANBL program compared to a non-tailored "Current Best Practices" smoking cessation program among AI smokers. Methods We will randomize 56 groups (8 smokers per group to the tailored program or non-tailored program for a total sample size of 448 American Indian smokers. All participants in the proposed study will be offered pharmacotherapy, regardless of group assignment. This study is the first controlled trial to examine the efficacy of a culturally-tailored smoking cessation program for American Indians. If the intervention is successful, the potential health impact is significant because the prevalence of smoking is the highest in this population. Trial Registration ClinicalTrials.gov: NCT01106456

  13. Study Protocol on Intentional Distortion in Personality Assessment: Relationship with Test Format, Culture, and Cognitive Ability.

    Science.gov (United States)

    Van Geert, Eline; Orhon, Altan; Cioca, Iulia A; Mamede, Rui; Golušin, Slobodan; Hubená, Barbora; Morillo, Daniel

    2016-01-01

    Self-report personality questionnaires, traditionally offered in a graded-scale format, are widely used in high-stakes contexts such as job selection. However, job applicants may intentionally distort their answers when filling in these questionnaires, undermining the validity of the test results. Forced-choice questionnaires are allegedly more resistant to intentional distortion compared to graded-scale questionnaires, but they generate ipsative data. Ipsativity violates the assumptions of classical test theory, distorting the reliability and construct validity of the scales, and producing interdependencies among the scores. This limitation is overcome in the current study by using the recently developed Thurstonian item response theory model. As online testing in job selection contexts is increasing, the focus will be on the impact of intentional distortion on personality questionnaire data collected online. The present study intends to examine the effect of three different variables on intentional distortion: (a) test format (graded-scale versus forced-choice); (b) culture, as data will be collected in three countries differing in their attitudes toward intentional distortion (the United Kingdom, Serbia, and Turkey); and (c) cognitive ability, as a possible predictor of the ability to choose the more desirable responses. Furthermore, we aim to integrate the findings using a comprehensive model of intentional distortion. In the Anticipated Results section, three main aspects are considered: (a) the limitations of the manipulation, theoretical approach, and analyses employed; (b) practical implications for job selection and for personality assessment in a broader sense; and PMID:27445902

  14. Study Protocol on Intentional Distortion in Personality Assessment: Relationship with Test Format, Culture, and Cognitive Ability

    Science.gov (United States)

    Van Geert, Eline; Orhon, Altan; Cioca, Iulia A.; Mamede, Rui; Golušin, Slobodan; Hubená, Barbora; Morillo, Daniel

    2016-01-01

    Self-report personality questionnaires, traditionally offered in a graded-scale format, are widely used in high-stakes contexts such as job selection. However, job applicants may intentionally distort their answers when filling in these questionnaires, undermining the validity of the test results. Forced-choice questionnaires are allegedly more resistant to intentional distortion compared to graded-scale questionnaires, but they generate ipsative data. Ipsativity violates the assumptions of classical test theory, distorting the reliability and construct validity of the scales, and producing interdependencies among the scores. This limitation is overcome in the current study by using the recently developed Thurstonian item response theory model. As online testing in job selection contexts is increasing, the focus will be on the impact of intentional distortion on personality questionnaire data collected online. The present study intends to examine the effect of three different variables on intentional distortion: (a) test format (graded-scale versus forced-choice); (b) culture, as data will be collected in three countries differing in their attitudes toward intentional distortion (the United Kingdom, Serbia, and Turkey); and (c) cognitive ability, as a possible predictor of the ability to choose the more desirable responses. Furthermore, we aim to integrate the findings using a comprehensive model of intentional distortion. In the Anticipated Results section, three main aspects are considered: (a) the limitations of the manipulation, theoretical approach, and analyses employed; (b) practical implications for job selection and for personality assessment in a broader sense; and (c) suggestions for further research. PMID:27445902

  15. Randomized controlled trial of postoperative exercise rehabilitation program after lumbar spine fusion: study protocol

    Directory of Open Access Journals (Sweden)

    Tarnanen Sami

    2012-07-01

    Full Text Available Abstract Background Lumbar spine fusion (LSF effectively decreases pain and disability in specific spinal disorders; however, the disability rate following surgery remains high. This, combined with the fact that in Western countries the number of LSF surgeries is increasing rapidly it is important to develop rehabilitation interventions that improve outcomes. Methods/design In the present RCT-study we aim to assess the effectiveness of a combined back-specific and aerobic exercise intervention for patients after LSF surgery. One hundred patients will be randomly allocated to a 12-month exercise intervention arm or a usual care arm. The exercise intervention will start three months after surgery and consist of six individual guidance sessions with a physiotherapist and a home-based exercise program. The primary outcome measures are low back pain, lower extremity pain, disability and quality of life. Secondary outcomes are back function and kinesiophobia. Exercise adherence will also be evaluated. The outcome measurements will be assessed at baseline (3 months postoperatively, at the end of the exercise intervention period (15 months postoperatively, and after a 1-year follow-up. Discussion The present RCT will evaluate the effectiveness of a long-term rehabilitation program after LSF. To our knowledge this will be the first study to evaluate a combination of strength training, control of the neutral lumbar spine position and aerobic training principles in rehabilitation after LSF. Trial registration ClinicalTrials.gov Identifier NCT00834015

  16. Advancing theories, models and measurement for an interprofessional approach to shared decision making in primary care: a study protocol

    Directory of Open Access Journals (Sweden)

    Frosch Dominick

    2008-01-01

    Full Text Available Abstract Background Shared decision-making (SDM is defined as a process by which a healthcare choice is made by practitioners together with the patient. Although many diagnostic and therapeutic processes in primary care integrate more than one type of health professional, most SDM conceptual models and theories appear to be limited to the patient-physician dyad. The objectives of this study are to develop a conceptual model and propose a set of measurement tools for enhancing an interprofessional approach to SDM in primary healthcare. Methods/Design An inventory of SDM conceptual models, theories and measurement tools will be created. Models will be critically assessed and compared according to their strengths, limitations, acknowledgement of interprofessional roles in the process of SDM and relevance to primary care. Based on the theory analysis, a conceptual model and a set of measurements tools that could be used to enhance an interprofessional approach to SDM in primary healthcare will be proposed and pilot-tested with key stakeholders and primary healthcare teams. Discussion This study protocol is informative for researchers and clinicians interested in designing and/or conducting future studies and educating health professionals to improve how primary healthcare teams foster active participation of patients in making health decisions using a more coordinated approach.

  17. A knowledge synthesis of patient and public involvement in clinical practice guidelines: study protocol

    Directory of Open Access Journals (Sweden)

    Tapp Sylvie

    2009-06-01

    Full Text Available Abstract Background Failure to reconcile patient preferences and values as well as social norms with clinical practice guidelines (CPGs recommendations may hamper their implementation in clinical practice. However, little is known about patients and public involvement programs (PPIP in CPGs development and implementation. This study aims at identifying what it is about PPIP that works, in which contexts are PPIP most likely to be effective, and how are PPIP assumed to lead to better CPGs development and implementation. Methods and design A knowledge synthesis will be conducted in four phases. In phase one, literature on PPIP in CPGs development will be searched through bibliographic databases. A call for bibliographic references and unpublished reports will also be sent via the mailing lists of relevant organizations. Eligible publications will include original qualitative, quantitative, or mixed methods study designs reporting on a PPIP pertaining to CPGs development or implementation. They will also include documents produced by CPGs organizations to describe their PPIP. In phase two, grounded in the program's logic model, two independent reviewers will extract data to collect information on the principal components and activities of PPIP, the resources needed, the contexts in which PPIP were developed and tested, and the assumptions underlying PPIP. Quality assessment will be made for all retained publications. Our literature search will be complemented with interviews of key informants drawn from of a purposive sample of CPGs developers and patient/public representatives. In phase three, we will synthesize evidence from both the publications and interviews data using template content analysis to organize the identified components in a meaningful framework of PPIP theories. During a face-to-face workshop, findings will be validated with different stakeholder and a final toolkit for CPGs developers will be refined. Discussion The proposed

  18. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an

  19. The impact of a bariatric rehabilitation service on weight loss and psychological adjustment - study protocol

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    Hollywood Amelia

    2012-04-01

    Full Text Available Abstract Background Bariatric surgery is currently the most effective form of obesity management for those whose BMI is greater than 40 (or 35 with co morbidities. A minority of patients, however, either do not show the desired loss of excess weight or show weight regain by follow up. Research highlights some of the reasons for this variability, most of which centres on the absence of any psychological support with patients describing how although surgery fixes their body, psychological issues relating to dietary control, self esteem, coping and emotional eating remain neglected. The present study aims to evaluate the impact of a health psychology led bariatric rehabilitation service (BRS on patient health outcomes. The bariatric rehabilitation service will provide information, support and mentoring pre and post surgery and will address psychological issues such as dietary control, self esteem, coping and emotional eating. The package reflects the rehabilitation services now common place for patients post heart attack and stroke which have been shown to improve patient health outcomes. Methods/Design The study is a randomised control trial and patients will be allocated to receive either usual care or the bariatric rehabilitation service pre and post bariatric surgery. Follow up measures of weight loss and psychological issues will be taken at baseline (2 weeks preoperatively, 3, 6 and 12 months postoperatively. The contents of the bariatric service and the follow up measures are based on previous pilot work and have been developed further by the research team working closely with two patient support groups (BOSPA & WLSinfo. This study will take place in St Richard's Hospital in Chichester in the UK. Discussion It is predicted that a bariatric rehabilitation service will improve weight loss following surgery and will also facilitate changes in other psychological variables such as quality of life, dietary control, self esteem, coping and

  20. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

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    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  1. Subgroups of musculoskeletal pain patients and their psychobiological patterns – The LOGIN study protocol

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    Gerhardt Andreas

    2012-08-01

    Full Text Available Abstract Background Pain conditions of the musculoskeletal system are very common and have tremendous socioeconomic impact. Despite its high prevalence, musculoskeletal pain remains poorly understood and predominantly non-specifically and insufficiently treated. The group of chronic musculoskeletal pain patients is supposed to be heterogeneous, due to a multitude of mechanisms involved in chronic pain. Psychological variables, psychophysiological processes, and neuroendocrine alterations are expected to be involved. Thus far, studies on musculoskeletal pain have predominantly focused on the general aspects of pain processing, thus neglecting the heterogeneity of patients with musculoskeletal pain. Consequently, there is a need for studies that comprise a multitude of mechanisms that are potentially involved in the chronicity and spread of pain. This need might foster research and facilitate a better pathophysiological understanding of the condition, thereby promoting the development of specific mechanism-based treatments for chronic pain. Therefore, the objectives of this study are as follows: 1 identify and describe subgroups of patients with musculoskeletal pain with regard to clinical manifestations (including mental co-morbidity and 2 investigate whether distinct sensory profiles or 3 distinct plasma levels of pain-related parameters due to different underlying mechanisms can be distinguished in various subgroups of pain patients. Methods/Design We will examine a population-based chronic pain sample (n = 100, a clinical tertiary care sample (n = 100 and pain-free patients with depression or post-traumatic stress disorder and pain-free healthy controls (each n = 30, respectively. The samples will be pain localisation matched by sex and age to the population-based sample. Patients will undergo physical examination and thorough assessments of mental co-morbidity (including psychological trauma, perceptual and central sensitisation

  2. Food choices and practices during pregnancy of immigrant and Aboriginal women in Canada: a study protocol

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    Higginbottom Gina MA

    2011-12-01

    Full Text Available Abstract Background Facilitating the provision of appropriate health care for immigrant and Aboriginal populations in Canada is critical for maximizing health potential and well-being. Numerous reports describe heightened risks of poor maternal and birth outcomes for immigrant and Aboriginal women. Many of these outcomes may relate to food consumption/practices and thus may be obviated through provision of resources which suit the women's ethnocultural preferences. This project aims to understand ethnocultural food and health practices of Aboriginal and immigrant women, and how these intersect with respect to the legacy of Aboriginal colonialism and to the social contexts of cultural adaptation and adjustment of immigrants. The findings will inform the development of visual tools for health promotion by practitioners. Methods/Design This four-phase study employs a case study design allowing for multiple means of data collection and different units of analysis. Phase 1 consists of a scoping review of the literature. Phases 2 and 3 incorporate pictorial representations of food choices (photovoice in Phase 2 with semi-structured photo-elicited interviews (in Phase 3. The findings from Phases 1-3 and consultations with key stakeholders will generate key understandings for Phase 4, the production of culturally appropriate visual tools. For the scoping review, an emerging methodological framework will be utilized in addition to systematic review guidelines. A research librarian will assist with the search strategy and retrieval of literature. For Phases 2 and 3, recruitment of 20-24 women will be facilitated by team member affiliations at perinatal clinics in one of the city's most diverse neighbourhoods. The interviews will reveal culturally normative practices surrounding maternal food choices and consumption, including how women negotiate these practices within their own worldview and experiences. A structured and comprehensive integrated knowledge

  3. Evaluating patient values and preferences for thromboprophylaxis decision making during pregnancy: a study protocol

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    Alonso-Coello Pablo

    2012-05-01

    Full Text Available Abstract Background Pregnant women with prior venous thromboembolism (VTE are at risk of recurrence. Low molecular weight heparin (LWMH reduces the risk of pregnancy-related VTE. LMWH prophylaxis is, however, inconvenient, uncomfortable, costly, medicalizes pregnancy, and may be associated with increased risks of obstetrical bleeding. Further, there is uncertainty in the estimates of both the baseline risk of pregnancy-related recurrent VTE and the effects of antepartum LMWH prophylaxis. The values and treatment preferences of pregnant women, crucial when making recommendations for prophylaxis, are currently unknown. The objective of this study is to address this gap in knowledge. Methods We will perform a multi-center cross-sectional interview study in Canada, USA, Norway and Finland. The study population will consist of 100 women with a history of lower extremity deep vein thrombosis (DVT or pulmonary embolism (PE, and who are either pregnant, planning pregnancy, or may in the future consider pregnancy (women between 18 and 45 years. We will exclude individuals who are on full dose anticoagulation or thromboprophylaxis, who have undergone surgical sterilization, or whose partners have undergone vasectomy. We will determine each participant's willingness to receive LMWH prophylaxis during pregnancy through direct choice exercises based on real life and hypothetical scenarios, preference-elicitation using a visual analog scale (“feeling thermometer”, and a probability trade-off exercise. The primary outcome will be the minimum reduction (threshold in VTE risk at which women change from declining to accepting LMWH prophylaxis. We will explore possible determinants of this choice, including educational attainment, the characteristics of the women’s prior VTE, and prior experience with LMWH. We will determine the utilities that women place on the burden of LMWH prophylaxis, pregnancy-related DVT, pregnancy-related PE and pregnancy

  4. Developing a decision aid to guide public sector health policy decisions: A study protocol

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    Brouwers Melissa

    2011-05-01

    Full Text Available Abstract Background Decision aids have been developed in a number of health disciplines to support evidence-informed decision making, including patient decision aids and clinical practice guidelines. However, policy contexts differ from clinical contexts in terms of complexity and uncertainty, requiring different approaches for identifying, interpreting, and applying many different types of evidence to support decisions. With few studies in the literature offering decision guidance specifically to health policymakers, the present study aims to facilitate the structured and systematic incorporation of research evidence and, where there is currently very little guidance, values and other non-research-based evidence, into the policy making process. The resulting decision aid is intended to help public sector health policy decision makers who are tasked with making evidence-informed decisions on behalf of populations. The intent is not to develop a decision aid that will yield uniform recommendations across jurisdictions, but rather to facilitate more transparent policy decisions that reflect a balanced consideration of all relevant factors. Methods/design The study comprises three phases: a modified meta-narrative review, the use of focus groups, and the application of a Delphi method. The modified meta-narrative review will inform the initial development of the decision aid by identifying as many policy decision factors as possible and other features of methodological guidance deemed to be desirable in the literatures of all relevant disciplines. The first of two focus groups will then seek to marry these findings with focus group members' own experience and expertise in public sector population-based health policy making and screening decisions. The second focus group will examine issues surrounding the application of the decision aid and act as a sounding board for initial feedback and refinement of the draft decision aid. Finally, the Delphi

  5. Study protocol: Audit and Best Practice for Chronic Disease Extension (ABCDE Project

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    Thompson Sandra

    2008-09-01

    Full Text Available Abstract Background A growing body of international literature points to the importance of a system approach to improve the quality of care in primary health care settings. Continuous Quality Improvement (CQI concepts and techniques provide a theoretically coherent and practical way for primary care organisations to identify, address, and overcome the barriers to improvements. The Audit and Best Practice for Chronic Disease (ABCD study, a CQI-based quality improvement project conducted in Australia's Northern Territory, has demonstrated significant improvements in primary care service systems, in the quality of clinical service delivery and in patient outcomes related to chronic illness care. The aims of the extension phase of this study are to examine factors that influence uptake and sustainability of this type of CQI activity in a variety of Indigenous primary health care organisations in Australia, and to assess the impact of collaborative CQI approaches on prevention and management of chronic illness and health outcomes in Indigenous communities. Methods/design The study will be conducted in 40–50 Indigenous community health centres from 4 States/Territories (Northern Territory, Western Australia, New South Wales and Queensland over a five year period. The project will adopt a participatory, quality improvement approach that features annual cycles of: 1 organisational system assessment and audits of clinical records; 2 feedback to and interpretation of results with participating health centre staff; 3 action planning and goal setting by health centre staff to achieve system changes; and 4 implementation of strategies for change. System assessment will be carried out using a System Assessment Tool and in-depth interviews of key informants. Clinical audit tools include two essential tools that focus on diabetes care audit and preventive service audit, and several optional tools focusing on audits of hypertension, heart disease, renal

  6. Effects of telemedicine in the treatment of patients with type 2 diabetes – a study protocol

    DEFF Research Database (Denmark)

    Hansen, Caroline Raun; Perrild, Hans; Koefoed, Birgitte Gade;

    2013-01-01

    is to examine whether telemedicine conferences with a nurse can contribute to achieving good diabetes control among patients with poorly regulated type 2 diabetes. MATERIAL AND METHODS: A total of 165 patients with type 2 diabetes who have formerly undergone a rehabilitation programme are randomized to either......: The study will examine whether telemedicine technology can contribute to achieving good diabetes regulation. FUNDING: The City of Copenhagen and the Prevention Fund of the Capital Region of Denmark funded the project. Also "Smedemester Niels Hansen og Hustru Johanne F. Frederiksens Legat" has supported...... telemedicine intervention or usual care. The intervention lasts for 32 weeks and consists of monthly videoconferences with a nurse from a health-care centre as an add-on to usual care. Blood sugar, blood pressure and weight are regularly self-monitored and measurements are automatically transferred...

  7. Development of quality indicators for monitoring outcomes of frail elderly hospitalised in acute care health settings: Study Protocol

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    Travers Catherine M

    2011-10-01

    Full Text Available Abstract Background Frail older people admitted to acute care hospitals are at risk of a range of adverse outcomes, including geriatric syndromes, although targeted care strategies can improve health outcomes for these patients. It is therefore important to assess inter-hospital variation in performance in order to plan and resource improvement programs. Clinical quality outcome indicators provide a mechanism for identifying variation in performance over time and between hospitals, however to date there has been no routine use of such indicators in acute care settings. A barrier to using quality indicators is lack of access to routinely collected clinical data. The interRAI Acute Care (AC assessment system supports comprehensive geriatric assessment of older people within routine daily practice in hospital and includes process and outcome data pertaining to geriatric syndromes. This paper reports the study protocol for the development of aged care quality indicators for acute care hospitals. Methods/Design The study will be conducted in three phases: 1. Development of a preliminary inclusive set of quality indicators set based on a literature review and expert panel consultation, 2. A prospective field study including recruitment of 480 patients aged 70 years or older across 9 Australian hospitals. Each patient will be assessed on admission and discharge using the interRAI AC, and will undergo daily monitoring to observe outcomes. Medical records will be independently audited, and 3. Analysis and compilation of a definitive quality indicator set, including two anonymous voting rounds for quality indicator inclusion by the expert panel. Discussion The approach to quality indicators proposed in this protocol has four distinct advantages over previous efforts: the quality indicators focus on outcomes; they can be collected as part of a routinely applied clinical information and decision support system; the clinical data will be robust and will

  8. Effectiveness of the universal prevention program 'Healthy School and Drugs': Study protocol of a randomized clustered trial

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    Malmberg Monique

    2010-09-01

    Full Text Available Abstract Background Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a quasi-experimental design before, many program changes were made afterwards. The present study, therefore, aims to test the effects of this widely used, renewed universal prevention program. Methods/Design A randomized clustered trial will be conducted among 3,784 adolescents of 23 secondary schools in The Netherlands. The trial has three conditions; two intervention conditions (i.e., e-learning and integral and a control condition. The e-learning condition consists of three digital learning modules (i.e., about alcohol, tobacco, and marijuana that are sequentially offered over the course of three school years (i.e., grade 1, grade 2, and grade 3. The integral condition consists of parental participation in a parental meeting on substance use, regulation of substance use, and monitoring and counseling of students' substance use at school, over and above the three digital modules. The control condition is characterized as business as usual. Participating schools were randomly assigned to either an intervention or control condition. Participants filled out a digital questionnaire at baseline and will fill out the same questionnaire three more times at follow-up measurements (8, 20, and 32 months after baseline. Outcome variables included in the questionnaire are the percentage of binge drinking (more than five drinks per occasion, the average weekly number of drinks, and the percentage of adolescents who ever drunk a glass of alcohol and the percentage of adolescents who ever smoked a cigarette or a joint respectively for tobacco and marijuana. Discussion This study protocol describes the design of a randomized clustered trial that evaluates the

  9. Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial

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    Holz Jonathan D

    2011-08-01

    Full Text Available Abstract Background Osteoporosis is a growing worldwide problem, with the greatest burden resulting from fractures. Nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (BMD only moderately lower than young normal individuals. Since long-term drug therapy is an expensive option with uncertain consequences and side effects, natural herbal therapy offers an attractive alternative. The purpose of this study is to evaluate the effect on BMD and safety of the Classic Yin and Yang Tonic Formula for treatment of osteopenia and to investigate the mechanism by which this efficacy is achieved. Methods/design We propose a multicenter double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of the Classic Yin and Yang Tonic Formula for the treatment of osteopenia. Participants aged 55 to 75 with low bone mineral density (T-score between -1 and -2.5 and kidney deficiency in TCM will be included and randomly allocated into two groups: treatment group and control group. Participants in the treatment group will be treated with Classic Yin and Yang Tonic Granule, while the controlled group will receive placebo. Primary outcome measure will be BMD of the lumbar spine and proximal femur using dual-energy X-ray absorptiometry. Secondary outcomes will include pain intensity measured with visual analogue scales, quality of life, serum markers of bone metabolism, indices of Neuro-endocrino-immune network and safety. Discussion If the Classic Yin and Yang Tonic Formula can increase bone mass without adverse effects, it may be a novel strategy for the treatment of osteoporosis. Furthermore, the mechanism of the Chinese medical formula for osteoporosis will be partially elucidated. Trial registration This study is registered at ClinicalTrials.gov, NCT01271647.

  10. A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

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    Sternlieb Beth

    2011-01-01

    Full Text Available Abstract Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823

  11. An exploration of how guideline developer capacity and guideline implementability influence implementation and adoption: study protocol

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    Lemieux-Charles Louise

    2009-07-01

    Full Text Available Abstract Background Practice guidelines can improve health care delivery and outcomes but several issues challenge guideline adoption, including their intrinsic attributes, and whether and how they are implemented. It appears that guideline format may influence accessibility and ease of use, which may overcome attitudinal barriers of guideline adoption, and appear to be important to all stakeholders. Guideline content may facilitate various forms of decision making about guideline adoption relevant to different stakeholders. Knowledge and attitudes about, and incentives and capacity for implementation on the part of guideline sponsors may influence whether and how they develop guidelines containing these features, and undertake implementation. Examination of these issues may yield opportunities to improve guideline adoption. Methods The attributes hypothesized to facilitate adoption will be expanded by thematic analysis, and quantitative and qualitative summary of the content of international guidelines for two primary care (diabetes, hypertension and institutional care (chronic ulcer, chronic heart failure topics. Factors that influence whether and how guidelines are implemented will be explored by qualitative analysis of interviews with individuals affiliated with guideline sponsoring agencies. Discussion Previous research examined guideline implementation by measuring rates of compliance with recommendations or associated outcomes, but this produced little insight on how the products themselves, or their implementation, could be improved. This research will establish a theoretical basis upon which to conduct experimental studies to compare the cost-effectiveness of interventions that enhance guideline development and implementation capacity. Such studies could first examine short-term outcomes predictive of guideline utilization, such as recall, attitude toward, confidence in, and adoption intention. If successful, then long-term objective

  12. Study protocol: national research partnership to improve primary health care performance and outcomes for Indigenous peoples

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    McDermott Robyn

    2010-05-01

    Full Text Available Abstract Background Strengthening primary health care is critical to reducing health inequity between Indigenous and non-Indigenous Australians. The Audit and Best practice for Chronic Disease Extension (ABCDE project has facilitated the implementation of modern Continuous Quality Improvement (CQI approaches in Indigenous community health care centres across Australia. The project demonstrated improvements in health centre systems, delivery of primary care services and in patient intermediate outcomes. It has also highlighted substantial variation in quality of care. Through a partnership between academic researchers, service providers and policy makers, we are now implementing a study which aims to 1 explore the factors associated with variation in clinical performance; 2 examine specific strategies that have been effective in improving primary care clinical performance; and 3 work with health service staff, management and policy makers to enhance the effective implementation of successful strategies. Methods/Design The study will be conducted in Indigenous community health centres from at least six States/Territories (Northern Territory, Western Australia, New South Wales, South Australia, Queensland and Victoria over a five year period. A research hub will be established in each region to support collection and reporting of quantitative and qualitative clinical and health centre system performance data, to investigate factors affecting variation in quality of care and to facilitate effective translation of research evidence into policy and practice. The project is supported by a web-based information system, providing automated analysis and reporting of clinical care performance to health centre staff and management. Discussion By linking researchers directly to users of research (service providers, managers and policy makers, the partnership is well placed to generate new knowledge on effective strategies for improving the quality of primary

  13. Development and Field-Testing of a Study Protocol, including a Web-Based Occupant Survey Tool, for Use in Intervention Studies of Indoor Environmental Quality

    Energy Technology Data Exchange (ETDEWEB)

    Mendell, Mark; Eliseeva, Ekaterina; Spears, Michael; Fisk, William J.

    2009-06-01

    We developed and pilot-tested an overall protocol for intervention studies to evaluate the effects of indoor environmental changes in office buildings on the health symptoms and comfort of occupants. The protocol includes a web-based survey to assess the occupant's responses, as well as specific features of study design and analysis. The pilot study, carried out on two similar floors in a single building, compared two types of ventilation system filter media. With support from the building's Facilities staff, the implementation of the filter change intervention went well. While the web-based survey tool worked well also, low overall response rates (21-34percent among the three work groups included) limited our ability to evaluate the filter intervention., The total number of questionnaires returned was low even though we extended the study from eight to ten weeks. Because another simultaneous study we conducted elsewhere using the same survey had a high response rate (>70percent), we conclude that the low response here resulted from issues specific to this pilot, including unexpected restrictions by some employing agencies on communication with occupants.

  14. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol

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    Chisholm Katharine

    2012-03-01

    Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors

  15. Visually Impaired OLder people's Exercise programme for falls prevenTion (VIOLET): a feasibility study protocol

    Science.gov (United States)

    Skelton, Dawn A; Bailey, Cathy; Howel, Denise; Cattan, Mima; Deary, Vincent; Coe, Dot; de Jong, Lex D; Gawler, Sheena; Gray, Joanne; Lampitt, Rosy; Wilkinson, Jennifer; Adams, Nicola

    2016-01-01

    Introduction In the UK, 1 in 5 people aged 75 and over live with sight loss. Visually impaired older people (VIOP) have an above average incidence of falls and 1.3–1.9 times more likely to experience hip fractures, than the general population. Older people with eye diseases are ∼3 times more likely than those with good vision, to limit activities due to fear of falling. This feasibility study aims to adapt the group-based Falls Management Exercise (FaME) programme to the needs of VIOP and carry out an external pilot trial to inform the design of a future definitive randomised controlled trial. Methods and design A UK based 2-centre mixed methods, randomised, feasibility study will be conducted over 28 months. Stakeholder panels, including VIOP, will make recommendations for adaptations to an existing exercise programme (FaME), to meet the needs of VIOP, promoting uptake and adherence, while retaining required effective components of the exercise programme. 80 VIOP aged 60 and over, living at home, ambulant with or without a walking aid, will be recruited in Newcastle (n=40) and Glasgow (n=40) through National Health Service (NHS) Trusts and third sector partners. Participants randomised into the intervention arm will receive the adapted FaME programme. Participants randomised into the control arm will continue with usual activity. Outcomes are, recruitment rate, adherence and validated measures including fear of falling and quality of life. Postintervention in-depth qualitative interviews will be conducted with a purposive sample of VIOP (N=10). Postural stability instructors will be interviewed, before trial-specific training and following the intervention. Ethics and dissemination Ethics approval was secured through the National Research Ethics Service (NRES) Committee North East, Newcastle and North Tyneside 2. Glasgow Caledonian University was approved as a non-NHS site with local ethics approval. Findings will be disseminated through peer

  16. Lifestyle modification and metformin as long-term treatment options for obese adolescents: study protocol

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    Watson Margaret

    2009-11-01

    Full Text Available Abstract Background Childhood obesity is a serious health concern affecting over 155 million children in developed countries worldwide. Childhood obesity is associated with significantly increased risk for development of type 2 diabetes, cardiovascular disease and psychosocial functioning problems (i.e., depression and decreased quality of life. The two major strategies for management of obesity and associated metabolic abnormalities are lifestyle modification and pharmacologic therapy. This paper will provide the background rationale and methods of the REACH childhood obesity treatment program. Methods/design The REACH study is a 2-year multidisciplinary, family-based, childhood obesity treatment program. Seventy-two obese adolescents (aged 10-16 years and their parents are being recruited to participate in this randomized placebo controlled trial. Participants are randomized to receive either metformin or placebo, and are then randomized to a moderate or a vigorous intensity supervised exercise program for the first 12-weeks. After the 12-week exercise program, participants engage in weekly exercise sessions with an exercise facilitator at a local community center. Participants engage in treatment sessions with a dietitian and social worker monthly for the first year, and then every three months for the second year. The primary outcome measure is change in body mass index and the secondary outcome measures are changes in body composition, risk factors for type 2 diabetes and cardiovascular disease, changes in diet, physical activity, and psychosocial well-being (e.g., quality of life. It is hypothesized that participants who take metformin and engage in vigorous intensity exercise will show the greatest improvements in body mass index. In addition, it is hypothesized that participants who adhere to the REACH program will show improvements in body composition, physical activity, diet, psychosocial functioning and risk factor profiles for type 2

  17. Knowledge-to-action processes in SHRTN collaborative communities of practice: A study protocol

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    Chambers Larry

    2011-02-01

    Full Text Available Abstract Background The Seniors Health Research Transfer Network (SHRTN Collaborative is a network of networks that work together to improve the health and health care of Ontario seniors. The collaborative facilitates knowledge exchange through a library service, knowledge brokers (KBs, local implementation teams, collaborative technology, and, most importantly, Communities of Practice (CoPs whose members work together to identify innovations, translate evidence, and help implement changes. This project aims to increase our understanding of knowledge-to-action (KTA processes mobilized through SHRTN CoPs that are working to improve the health of Ontario seniors. For this research, KTA refers to the movement of research and experience-based knowledge between social contexts, and the use of that knowledge to improve practice. We will examine the KTA processes themselves, as well as the role of human agents within those processes. The conceptual framework we have adopted to inform our research is the Promoting Action on Research Implementation in Health Services (PARIHS framework. Methods/design This study will use a multiple case study design (minimum of nine cases over three years to investigate how SHRTN CoPs work and pursue knowledge exchange in different situations. Each case will yield a unique narrative, framed around the three PARIHS dimensions: evidence, context, and facilitation. Together, the cases will shed light on how SHRTN CoPs approach their knowledge exchange initiatives, and how they respond to challenges and achieve their objectives. Data will be collected using interviews, document analysis, and ethnographic observation. Discussion This research will generate new knowledge about the defining characteristics of CoPs operating in the health system, on leadership roles in CoPs, and on the nature of interaction processes, relationships, and knowledge exchange mechanisms. Our work will yield a better understanding of the factors that

  18. Protocol for a randomized controlled study of Iyengar yoga for youth with irritable bowel syndrome

    Directory of Open Access Journals (Sweden)

    Sternlieb Beth

    2011-01-01

    Full Text Available Abstract Introduction Irritable bowel syndrome affects as many as 14% of high school-aged students. Symptoms include discomfort in the abdomen, along with diarrhea and/or constipation and other gastroenterological symptoms that can significantly impact quality of life and daily functioning. Emotional stress appears to exacerbate irritable bowel syndrome symptoms suggesting that mind-body interventions reducing arousal may prove beneficial. For many sufferers, symptoms can be traced to childhood and adolescence, making the early manifestation of irritable bowel syndrome important to understand. The current study will focus on young people aged 14-26 years with irritable bowel syndrome. The study will test the potential benefits of Iyengar yoga on clinical symptoms, psychospiritual functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and spiritual benefits to practitioners and has been associated with reduced stress and pain. Through its focus on restoration and use of props, Iyengar yoga is especially designed to decrease arousal and promote psychospiritual resources in physically compromised individuals. An extensive and standardized teacher-training program support Iyengar yoga's reliability and safety. It is hypothesized that yoga will be feasible with less than 20% attrition; and the yoga group will demonstrate significantly improved outcomes compared to controls, with physiological and psychospiritual mechanisms contributing to improvements. Methods/Design Sixty irritable bowel syndrome patients aged 14-26 will be randomly assigned to a standardized 6-week twice weekly Iyengar yoga group-based program or a wait-list usual care control group. The groups will be compared on the primary clinical outcomes of irritable bowel syndrome symptoms, quality of life and global improvement at post-treatment and 2-month follow-up. Secondary outcomes will include visceral pain sensitivity assessed with a standardized

  19. EXACKTE2: Exploiting the clinical consultation as a knowledge transfer and exchange environment: a study protocol

    Directory of Open Access Journals (Sweden)

    Ouimet Mathieu

    2009-03-01

    Full Text Available Abstract Background While the evidence suggests that the way physicians provide information to patients is crucial in helping patients decide upon a course of action, the field of knowledge translation and exchange (KTE is silent about how the physician and the patient influence each other during clinical interactions and decision-making. Consequently, based on a novel relationship-centered model, EXACKTE2 (EXploiting the clinicAl Consultation as a Knowledge Transfer and Exchange Environment, this study proposes to assess how patients and physicians influence each other in consultations. Methods We will employ a cross-sectional study design involving 300 pairs of patients and family physicians from two primary care practice-based research networks. The consultation between patient and physician will be audio-taped and transcribed. Following the consultation, patients and physicians will complete a set of questionnaires based on the EXACKTE2 model. All questionnaires will be similar for patients and physicians. These questionnaires will assess the key concepts of our proposed model based on the essential elements of shared decision-making (SDM: definition and explanation of problem; presentation of options; discussion of pros and cons; clarification of patient values and preferences; discussion of patient ability and self-efficacy; presentation of doctor knowledge and recommendation; and checking and clarifying understanding. Patients will be contacted by phone two weeks later and asked to complete questionnaires on decisional regret and quality of life. The analysis will be conducted to compare the key concepts in the EXACKTE2 model between patients and physicians. It will also allow the assessment of how patients and physicians influence each other in consultations. Discussion Our proposed model, EXACKTE2, is aimed at advancing the science of KTE based on a relationship process when decision-making has to take place. It fosters a new KTE

  20. Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol

    Directory of Open Access Journals (Sweden)

    Leatherdale Scott T

    2011-09-01

    Full Text Available Abstract Background Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered - do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required. Methods/Design A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months. Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000. Eligible subjects interested in free NRT will be determined at baseline (N = 1,000 and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco at 6-month follow-up as compared to subjects who do not

  1. Study protocol subacromial impingement syndrome: the identification of pathophysiologic mechanisms (SISTIM

    Directory of Open Access Journals (Sweden)

    de Witte Pieter

    2011-12-01

    Full Text Available Abstract Background The Subacromial Impingement Syndrome (SIS is the most common diagnosed disorder of the shoulder in primary health care, but its aetiology is unclear. Conservative treatment regimes focus at reduction of subacromial inflammatory reactions or pathologic scapulohumeral motion patterns (intrinsic aetiology. Long-lasting symptoms are often treated with surgery, which is focused at enlarging the subacromial space by resection of the anterior part of the acromion (based on extrinsic aetiology. Despite that acromionplasty is in the top-10 of orthopaedic surgical procedures, there is no consensus on its indications and reported results are variable (successful in 48-90%. We hypothesize that the aetiology of SIS, i.e. an increase in subacromial pressure or decrease of subacromial space, is multi-factorial. SIS can be the consequence of pathologic scapulohumeral motion patterns leading to humerus cranialisation, anatomical variations of the scapula and the humerus (e.g. hooked acromion, a subacromial inflammatory reaction (e.g. due to overuse or micro-trauma, or adjoining pathology (e.g. osteoarthritis in the acromion-clavicular-joint with subacromial osteophytes. We believe patients should be treated according to their predominant etiological mechanism(s. Therefore, the objective of our study is to identify and discriminate etiological mechanisms occurring in SIS patients, in order to develop tailored diagnostic and therapeutic strategies. Methods In this cross-sectional descriptive study, applied clinical and experimental methods to identify intrinsic and extrinsic etiologic mechanisms comprise: MRI-arthrography (eligibility criteria, cuff status, 3D-segmented bony contours; 3D-motion tracking (scapulohumeral rhythm, arm range of motion, dynamic subacromial volume assessment by combining the 3D bony contours and 3D-kinematics; EMG (adductor co-activation and dynamometry instrumented shoulder radiographs during arm tasks (force and

  2. Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bernal Daniel DL

    2012-04-01

    Full Text Available Abstract Background Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. Methods/Design We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. Discussion As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible

  3. Oxygen persufflation as adjunct in liver preservation (OPAL: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Scherag Andre

    2011-10-01

    Full Text Available Abstract Background Early graft dysfunction due to preservation/reperfusion injury represents a dramatic event after liver transplantation. Enhancement of donor organ criteria, in order to cope with the ever increasing donor shortage, further increases graft susceptibility to ischemic alterations. Major parts of post-preservation injury, however, occur at the time of warm reperfusion but not during ischemic storage; successful reperfusion of ischemic tissue in turn depends on an adequate redox and intracellular signal homeostasis. The latter has been shown experimentally to be favorably influenced by oxygen persufflation within short time spans. Thus viability of marginally preserved liver grafts could still be augmented by transient hypothermic reconditioning even after normal procurement and static cold storage. The present study is aimed to confirm the conceptual expectations, that hypothermic reconditioning by gaseous oxygen persufflation is a useful method to suppress injurious cellular activation cascades and to improve post-ischemic recovery of marginally preserved liver grafts. Methods/Design OPAL is a prospective single center randomized proof of concept study, including two parallel groups in a total of 116 liver transplant patients. The effect of an in hospital treatment of the isolated liver graft by 2 hours of oxygen persufflation immediately prior to transplantation will be assesses as compared to standard procedure (cold storage without further intervention. The primary endpoint is the peak transaminase serum level (AST during the first three days after transplantation as a surrogate readout for parenchymal liver injury. Other outcomes comprise patient and graft survival, time of intensive care requirement, hepatic tissue perfusion 1h after revascularisation, early onset of graft dysfunction based on coagulation parameters, as well as the use of a refined scoring-system for initial graft function based on a multi-parameter (AST

  4. Study and Design an Anycast Routing Protocol for Wireless Sensor Networks

    Directory of Open Access Journals (Sweden)

    Demin Gao

    2011-12-01

    Full Text Available In wireless sensor networks, there is usually a sink which gathers data from the battery-powered sensor nodes. As sensor nodes around the sink consume their energy faster than the other nodes, several sinks have to be deployed to increase the network lifetime. Anycast is a mechanism that the source node sends the data to the nearest sink node. The paper study and design an anycast service for deploying several sinks in wireless sensor network. A novel anycast tree-based is proposed approach to minimize the path cost. Here the nodes form a tree with a sink node as the root, while the height of the tree integrates multiple metrics to calculate path cost based on diverse selection criteria. This paper discusses and analyzes the model deeply. The experimental data proves its validity and efficiency. Computer simulation shows that the proposed scheme reduces and balances the energy consumption among the nodes effectively, so it significantly extends the network lifetime compared to the existing schemes.

  5. The Reinforcing Therapist Performance (RTP experiment: Study protocol for a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Godley Mark D

    2010-01-01

    Full Text Available Abstract Background Rewarding provider performance has been recommended by the Institute of Medicine as an approach to improve the quality of treatment, yet little empirical research currently exists that has examined the effectiveness and cost-effectiveness of such approaches. The aim of this study is to test the effectiveness and cost-effectiveness of providing monetary incentives directly to therapists as a method to improve substance abuse treatment service delivery and subsequent client treatment outcomes. Design Using a cluster randomized design, substance abuse treatment therapists from across 29 sites were assigned by site to either an implementation as usual (IAU or pay-for-performance (P4P condition. Participants Substance abuse treatment therapists participating in a large dissemination and implementation initiative funded by the Center for Substance Abuse Treatment. Intervention Therapists in both conditions received comprehensive training and ongoing monitoring, coaching, and feedback. However, those in the P4P condition also were given the opportunity to earn monetary incentives for achieving two sets of measurable behaviors related to quality implementation of the treatment. Outcomes Effectiveness outcomes will focus on the impact of the monetary incentives to increase the proportion of adolescents who receive a targeted threshold level of treatment, months that therapists demonstrate monthly competency, and adolescents who are in recovery following treatment. Similarly, cost-effectiveness outcomes will focus on cost per adolescent receiving targeted threshold level of treatment, cost per month of demonstrated competence, and cost per adolescent in recovery. Trial Registration Trial Registration Number: NCT01016704

  6. Study protocol: can a school gardening intervention improve children’s diets?

    Directory of Open Access Journals (Sweden)

    Christian Meaghan S

    2012-04-01

    Full Text Available Abstract Background The current academic literature suggests there is a potential for using gardening as a tool to improve children’s fruit and vegetable intake. This study is two parallel randomised controlled trials (RCT devised to evaluate the school gardening programme of the Royal Horticultural Society (RHS Campaign for School Gardening, to determine if it has an effect on children’s fruit and vegetable intake. Method/Design Trial One will consist of 26 schools; these schools will be randomised into two groups, one to receive the intensive intervention as “Partner Schools” and the other to receive the less intensive intervention as “Associate Schools”. Trial Two will consist of 32 schools; these schools will be randomised into either the less intensive intervention “Associate Schools” or a comparison group with delayed intervention. Baseline data collection will be collected using a 24-hour food diary (CADET to collect data on dietary intake and a questionnaire exploring children’s knowledge and attitudes towards fruit and vegetables. A process measures questionnaire will be used to assess each school’s gardening activities. Discussion The results from these trials will provide information on the impact of the RHS Campaign for School Gardening on children’s fruit and vegetable intake. The evaluation will provide valuable information for designing future research in primary school children’s diets and school based interventions. Trial registration ISRCTN11396528

  7. Improving adherence to medication in stroke survivors (IAMSS: a randomised controlled trial: study protocol

    Directory of Open Access Journals (Sweden)

    Johnston Marie

    2010-02-01

    Full Text Available Abstract Background Adherence to therapies is a primary determinant of treatment success, yet the World Health Organisation estimate that only 50% of patients who suffer from chronic diseases adhere to treatment recommendations. In a previous project, we found that 30% of stroke patients reported sub-optimal medication adherence, and this was associated with younger age, greater cognitive impairment, lower perceptions of medication benefits and higher specific concerns about medication. We now wish to pilot a brief intervention aimed at (a helping patients establish a better medication-taking routine, and (b eliciting and modifying any erroneous beliefs regarding their medication and their stroke. Methods/Design Thirty patients will be allocated to a brief intervention (2 sessions and 30 to treatment as usual. The primary outcome will be adherence measured over 3 months using Medication Event Monitoring System (MEMS pill containers which electronically record openings. Secondary outcomes will include self reported adherence and blood pressure. Discussion This study shall also assess uptake/attrition, feasibility, ease of understanding and acceptability of this complex intervention. Trial Registration Current Controlled Trials ISRCTN38274953

  8. Requirements and design of the PROSPER protocol for implementation of information infrastructures supporting pandemic response: a Nominal Group study.

    Directory of Open Access Journals (Sweden)

    Toomas Timpka

    Full Text Available BACKGROUND: Advanced technical systems and analytic methods promise to provide policy makers with information to help them recognize the consequences of alternative courses of action during pandemics. Evaluations still show that response programs are insufficiently supported by information systems. This paper sets out to derive a protocol for implementation of integrated information infrastructures supporting regional and local pandemic response programs at the stage(s when the outbreak no longer can be contained at its source. METHODS: Nominal group methods for reaching consensus on complex problems were used to transform requirements data obtained from international experts into an implementation protocol. The analysis was performed in a cyclical process in which the experts first individually provided input to working documents and then discussed them in conferences calls. Argument-based representation in design patterns was used to define the protocol at technical, system, and pandemic evidence levels. RESULTS: The Protocol for a Standardized information infrastructure for Pandemic and Emerging infectious disease Response (PROSPER outlines the implementation of information infrastructure aligned with pandemic response programs. The protocol covers analyses of the community at risk, the response processes, and response impacts. For each of these, the protocol outlines the implementation of a supporting information infrastructure in hierarchical patterns ranging from technical components and system functions to pandemic evidence production. CONCLUSIONS: The PROSPER protocol provides guidelines for implementation of an information infrastructure for pandemic response programs both in settings where sophisticated health information systems already are used and in developing communities where there is limited access to financial and technical resources. The protocol is based on a generic health service model and its functions are adjusted for

  9. Ultrafast cone-beam computed tomography : a comparative study of imaging protocols during image-guided therapy procedure

    OpenAIRE

    Jijo Paul; Annamma Chacko; Mohammad Farhang; Shahram Kamali; Mohsen Tavanania; Thomas Vogl; Bita Panahi

    2015-01-01

    Objective. To evaluate two ultrafast cone-beam CT (UF-CBCT) imaging protocols with different acquisition and injection parameters regarding image quality and required contrast media during image-guided hepatic transarterial chemoembolization (TACE). Methods. In 80 patients (male: 46, female: 34; mean age: 56.8 years; range: 33–83) UF-CBCT was performed during TACE for intraprocedural guidance. Imaging was performed using two ultrafast CBCT acquisition protocols with different acquisition and ...

  10. Heart and Stroke Foundation of Ontario (HSFO high blood pressure strategy's hypertension management initiative study protocol

    Directory of Open Access Journals (Sweden)

    Von Sychowski Shirley

    2008-12-01

    Full Text Available Abstract Background Achieving control of hypertension prevents target organ damage at both the micro and macrovascular level and is a highly cost effective means of lowering the risk for heart attack and stroke particularly in people with diabetes. Clinical trials demonstrate that blood pressure control can be achieved in a large proportion of people. Translating this knowledge into widespread practice is the focus of the Hypertension Management Initiative, which began in 2004 with the goal of improving the management of this chronic health condition by primary care providers and patients in the community. Methods This study will test the effect of a systems change on the management of high blood pressure in real world practice in primary care in Ontario, Canada. The systems change intervention involves an interprofessional educational program bringing together physicians, nurses and pharmacists with tools for both providers and patients to facilitate blood pressure management. Each of two waves of subjects were enrolled over a 6 month period with the initial enrollment between waves separated by 9 months. Blood pressure will be measured with the BpTru ® automated blood pressure device. To determine the effectiveness of the intervention, a before and after analysis within all subjects will compare blood pressure at baseline to annual measurements for the three year study. To assess whether the intervention has an impact on blood pressure control independent of community trends, a betwen group comparison of baseline blood pressures in the delayed wave will be made with the immediate wave during the same time period, so that the immediate wave has experienced the intervention for at least 9 months. The total enrollment goal is 5,000 subjects. The practice locations include 10 Family Health Teams (FHTs and 1 Community Health Centre (CHC and approximately 49 primary care physicians, 15 nurse practitioners, 37 registered nurses and over 150

  11. The Protocol for the Early vs. Late Infantile Strabismus Surgery Study.

    Science.gov (United States)

    Simonsz, H

    1993-01-01

    The Early vs. Late Infantile Strabismus Surgery Study Group is a group of strabismologists and orthoptists who investigate whether early or late surgery is preferable in infantile strabismus, in a non-randomized, prospective, multi-centre trial. Infants between 6 and 18 months of age will receive a standardized entry examination and then be operated either before their second anniversary in clinics A, or between their 32nd and 60th month of age in clinics B. The children will be evaluated at age six. After completion of the study, the two groups can then be compared regarding degree of binocular vision, angle of strabismus and visual acuity of the worse eye relative to the better. Zentrum zur methodischen Betreuung von Therapiestudien, Mrs H. Dinkel, Universität Heidelberg, Im Neuenheimer Feld 305, W-69120 Heidelberg. 49.6221.565500. fax: 564195 Germany PD Dr. H.J. Simonsz, Orthoptics & Neuroophthalmology, Afdeling Oogheelkunde, University Hospital Dijkzigt, Dr. Molewaterplein 40, NL 3015 GD Rotterdam. 3 i. 10.4639222, ask for beeper 3394 fax: 4635105 The Netherlands PD Dr. med. G.H. Rolling, Schule für Orthoptik, Universitäts-Augenklinik, Im Neuenheimer Feld 400, W-69047 Heidelberg. 49.6221.566627/34/39 fax: 565422 Germany Dipl.-Inform. Med. U. Haag, Universität Heidelberg, Zentrum zur methodischen Betreuung von Therapiestudien, Im Neuenheimer Feld 305, W-69120 Heidelberg. 49.6221.564192 fax: 564195 Germany Dr. A. Deák, Augenklinik, Korányi Fasor, U-6720 Szeged. 36.62.12321/10822 fax: 22826 Hungary Mr P. Fells, F.R.C.S., F.C. Ophth., Lower Corridor Suite, Moorfields Eye Hospital, City Road, ECIV 2PD London. 44.71.2533411 fax: 2534696 (lower corridor suite) England Prof. R. Frosini, Istituto di Clinica Oculista dell' Universita di Firenze, Insegnamento di Ottica Fisiopatologica, Viale Morgagni 85,1-50134 Florence. Dr. R. Gomez de Liaño, Nuñez de Balboa 81, E-28006 Madrid. 34.1.5763229/72318 Spain Dr. O. Haugen, Orthoptic Department, Department of

  12. Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rosenberg Jacob

    2011-08-01

    Full Text Available Abstract Background Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results. Methods DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL to the traditional Hartmann's Procedure (HP. Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL, re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40. Discussion HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life. Trial registration British registry (ISRCTN for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287

  13. The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Swift Louise

    2011-07-01

    Full Text Available Abstract Background The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. Methods/Design A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts. Subjects: Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs. Primary objective: To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS 36 Item Short Form Health Survey version 2 [SF-36v2]. Secondary objectives: To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT basis. Discussion The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is

  14. Exercise rehabilitation on home-dwelling patients with Alzheimer's disease - a randomized, controlled trial. Study protocol

    Directory of Open Access Journals (Sweden)

    Tilvis Reijo S

    2010-10-01

    Full Text Available Abstract Background Besides cognitive decline, Alzheimer's disease (AD leads to physical disability, need for help and permanent institutional care. The trials investigating effects of exercise rehabilitation on physical functioning of home-dwelling older dementia patients are still scarce. The aim of this study is to investigate the effectiveness of intensive exercise rehabilitation lasting for one year on mobility and physical functioning of home-dwelling patients with AD. Methods During years 2008-2010, patients with AD (n = 210 living with their spousal caregiver in community are recruited using central AD registers in Finland, and they are offered exercise rehabilitation lasting for one year. The patients are randomized into three arms: 1 tailored home-based exercise twice weekly 2 group-based exercise twice weekly in rehabilitation center 3 control group with usual care and information of exercise and nutrition. Main outcome measures will be Guralnik's mobility and balance tests and FIM-test to assess physical functioning. Secondary measures will be cognition, neuropsychiatric symptoms according to the Neuropsychiatric Inventory, caregivers' burden, depression and health-related quality of life (RAND-36. Data concerning admissions to institutional care and the use and costs of health and social services will be collected during a two year follow-up. Discussion To our knowledge this is the first large scale trial exploring whether home-dwelling patients with AD will benefit from intense and long-lasting exercise rehabilitation in respect to their mobility and physical functioning. It will also provide data on cost-effectiveness of the intervention. Trial registration ACTRN12608000037303

  15. Pilot study of the IAEA protocol for clinical commissioning of treatment planning systems

    International Nuclear Information System (INIS)

    Clinical test cases to facilitate the commissioning process of radiotherapy treatment planning system (TPS) were developed by participants of the IAEA coordinated research project (CRP) on 'Development of procedures for quality assurance for dosimetry calculation in radiotherapy'. The tests cover basic treatment techniques in typical radiotherapy installations and are based on the use of CIRS torso phantom. The practicability of the commissioning tests is assured through their trial use in the clinical facilities of different sizes. All hospitals used the same type of phantom which was scanned twice with computer tomography (CT). At the first scan different inserts were introduced into the phantom to derive the CT number to relative electron density conversion curve. At the second scan the phantom CT slices were acquired for planning of different clinical test cases on TPS. The dose was measured with ionization chamber placed inside the phantom. In this work we present the results from eleven hospitals which are using fifteen different TPSs. Altogether there are 37 different combinations of algorithms and beam qualities. The use of the phantom and the tests proposed in the CRP enabled the evaluation of accuracy and limitations of different algorithms as well as inconsistencies in the loaded data. The differences between TPS dose calculations and measurements for different photon beam algorithms and inhomogeneity correction methods which exceed 3% tolerance limit are shown. More results for different clinical test cases as well as test descriptions will be presented at the conference. Results of the pilot study have shown that proposed test cases can not only serve to ensure the safe use of the TPS in a specific clinic, but may also help the user to appreciate the possibilities of their system and understand its limitations. The set of tests for clinical commissioning can be performed in reasonable time in the majority of hospitals, particularly in those with

  16. Extended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol.

    Science.gov (United States)

    Cohen, Alexander Thomas; Spiro, Theodore Erich; Büller, Harry Roger; Haskell, Lloyd; Hu, Dayi; Hull, Russell; Mebazaa, Alexandre; Merli, Geno; Schellong, Sebastian; Spyropoulos, Alex; Tapson, Victor

    2011-05-01

    Patients with acute medical illnesses are at increased risk of venous thromboembolism (VTE), a significant cause of morbidity and mortality. Thromboprophylaxis is recommended in these patients but questions remain regarding the optimal duration of therapy. The aim of this study is to determine whether oral rivaroxaban is non-inferior to standard-duration (approximately 10 days) subcutaneous (s.c.) enoxaparin for the prevention of VTE in acutely ill medical patients, and whether extended-duration (approximately 5 weeks) rivaroxaban is superior to standard-duration enoxaparin. Patients aged 40 years or older and hospitalized for various acute medical illnesses with risk factors for VTE randomly receive either s.c. enoxaparin 40 mg once daily (od) for 10 ± 4 days or oral rivaroxaban 10 mg od for 35 ± 4 days. The primary efficacy outcomes are the composite of asymptomatic proximal deep vein thrombosis (DVT), symptomatic DVT, symptomatic non-fatal pulmonary embolism (PE), and VTE-related death up to day 10 + 4 and up to day 35 + 4. The primary safety outcome is the composite of treatment-emergent major bleeding and clinically relevant non-major bleeding. As of July 2010, 8,101 patients from 52 countries have been randomized. These patients have a broad range of medical conditions: approximately one-third were diagnosed with acute heart failure, just under one-third were diagnosed with acute infectious disease, and just under one-quarter were diagnosed with acute respiratory insufficiency. MAGELLAN will determine the efficacy, safety, and pharmacological profile of oral rivaroxaban for the prevention of VTE in a diverse population of medically ill patients and the potential of extended-duration therapy to reduce incidence of VTE.

  17. Weight Care Project: Health professionals' attitudes and ability to assess body weight status - Study protocol

    LENUS (Irish Health Repository)

    Moorhead, Anne

    2011-03-31

    Abstract Background Health professionals working in primary care and public health have opportunities to address body weight status issues with their patients through face-to-face contact. The objectives of this all-Ireland project are: 1. to assess the attitudes, current practices\\/behaviours and knowledge of key health professional groups on body weight status; 2. to assess the health professional groups\\' ability to identify body weight status in both adults and children. The health professional groups are: (a) community related public health nurses; (b) school public health nurses; (c) GPs and practice nurses (primary care); and (d) occupational health nurses (workplace) from both Northern Ireland and the Republic of Ireland. Methods\\/Design This all-Ireland multi-disciplinary project follows a mixed methods approach using both quantitative and qualitative methodologies, and consists of four components: 1. Literature review - to explore the role of health professionals in managing obesity through spontaneous intervention in a variety of health promotion settings. 2. Telephone interviews and focus groups - to gain an in-depth insight into the views of health professionals in assessing body weight status. 3. Survey (primarily online but also paper-based) - to determine the attitudes, current practices\\/behaviours and knowledge of health professionals in assessing body weight status. 4. Online evaluation study - an online interactive programme will be developed to assess health professionals\\' ability to identify the body weight status of adults and children. Discussion This project will assess and report the attitudes, current practices\\/behaviours and knowledge of key health professional groups within Northern Ireland and the Republic of Ireland on body weight status, and their ability to identify body weight status in both adults and children. The results of this project will generate recommendations for clinical practice in managing obesity, which may

  18. Individual Cognitive Stimulation Therapy for dementia (iCST: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Orrell Martin

    2012-09-01

    Full Text Available Abstract Background Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST programme for people with dementia which can be delivered by their family carer. Methods This multi-centre, pragmatic randomised controlled trial (RCT will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks. For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective. Discussion The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT.

  19. Clinical Study of Endostar Combined with DP Protocol in Treatment of Advanced Esophageal Cancer

    Directory of Open Access Journals (Sweden)

    Wen-ying DENG

    2015-09-01

    Full Text Available Objective: To observe the clinical outcomes of Endostar combined with DP regimen for treating advanced esophageal cancer.Methods: A total of 62 patients with advanced esophageal cancer admitted from May, 2011 to May, 2013 were enrolled for a prospective, randomized controlled trial and 2 cases were excluded from the study because of Ⅳ degree of digestive tract reaction and myelosuppression. Therefore, 60 cases could be evaluated, and then divided into combined group (given Endostar+DP plan and single chemotherapy group, 30 cases in each group. The level of VEGF, tumor size and CT perfusion (CTP parameters, including blood flow (BF, blood volume (BV, mean transit time (MTT, and permeability surface (PS before and after treatment were determined for comparison. Kaplan-Merier method was used to analyze the overall survival (OS of 2 groups.Results: The efficacy of combined group was superior to single chemotherapy group. The level of vascular endothelial growth factor (VEGF in combined group was obviously lower than that in single chemotherapy group after treatment (P<0.01. Compared with treatment before in combined group, BF, BV and PS decreased while MTT increased after treatment (P<0.05. However, there were no significant differences in single chemotherapygroup before and after treatment (P>0.05. The median OS was 30 months (95%CI: 20.935-39.065 for combined group and 21 months (95%CI: 15.109-26.591 for single chemotherapy group, respectively (P=0.048. The 1-, 2- and 3-year survival rates were 86.2%, 59.3% and 36.6% in combined group, and 70.8%, 32.1% and 17.8% in single chemotherapy group, respectively.Conclusion: Endostar can down-regulate the expression of VEGF, improve the state of hypertransfusion and high permeability of tumor vessels, has better curative effect without slighter adverse reactions, and prolong the survival time of patients with advanced esophageal cancer when combined with chemotherapy.

  20. Clinical Study of Endostar Combined with DP Protocol in Treatment of Advanced Esophageal Cancer

    Institute of Scientific and Technical Information of China (English)

    DENG Wen-ying; LI Ning; LUO Su-xia

    2015-01-01

    Objective: To observe the clinical outcomes of Endostar combined with DP regimen for treating advanced esophageal cancer. Methods: A total of 62 patients with advanced esophageal cancer admitted from May, 2011 to May, 2013 were enrolled for a prospective, randomized controlled trial and 2 cases were excluded from the study because ofⅣ degree of digestive tract reaction and myelosuppression. Therefore, 60 cases could be evaluated, and then divided into combined group (given Endostar+DP plan) and single chemotherapy group, 30 cases in each group. The level of VEGF, tumor size and CT perfusion (CTP) parameters, including blood flow (BF), blood volume (BV), mean transit time (MTT), and permeability surface (PS) before and after treatment were determined for comparison. Kaplan-Merier method was used to analyze the overall survival (OS) of 2 groups. Results:The efifcacy of combined group was superior to single chemotherapy group. The level of vascular endothelial growth factor (VEGF) in combined group was obviously lower than that in single chemotherapy group after treatment (P0.05). The median OS was 30 months (95%CI: 20.935-39.065) for combined group and 21 months (95%CI: 15.109-26.591) for single chemotherapy group, respectively (P=0.048). The 1-, 2- and 3-year survival rates were 86.2%, 59.3% and 36.6% in combined group, and 70.8%, 32.1% and 17.8% in single chemotherapy group, respectively. Conclusion: Endostar can down-regulate the expression of VEGF, improve the state of hypertransfusion and high permeability of tumor vessels, has better curative effect without slighter adverse reactions, and prolong the survival time of patients with advanced esophageal cancer when combined with chemotherapy.

  1. Study Protocol: A randomized controlled trial of patient navigation-activation to reduce cancer health disparities

    Directory of Open Access Journals (Sweden)

    Rousseau Sally

    2010-10-01

    Full Text Available Abstract Background Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment. Methods/Design The Rochester Patient Navigation Research Program (PNRP is a National Cancer Institute-sponsored, patient-level randomized trial (RCT of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge. Discussion This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs. Trials Registration clinicaltrials.gov identifier NCT

  2. Turning evidence into recommendations: Protocol of a study guideline development groups

    Directory of Open Access Journals (Sweden)

    Alderson Phil

    2007-09-01

    Full Text Available Abstract Background Health care practice based on research evidence requires that evidence is synthesised, and that recommendations based on this evidence are implemented. It also requires an intermediate step: translating synthesised evidence into practice recommendations. There is considerable literature on evidence synthesis and implementation, but little on how guideline development groups (GDGs produce recommendations. This is a complex process, with many influences on communication and decision-making, e.g., the quality of evidence, methods of presentation, practical/resource constraints, individual values, professional and scientific interests, social and psychological processes. To make this process more transparent and potentially effective, we need to understand these influences. Psychological theories of decision-making and social influence provide a framework for this understanding. Objectives This study aims to investigate the processes by which GDGs formulate recommendations, drawing on psychological theories of decision-making and social influence. The findings will potentially inform the further evolution of GDG methods, such as choice of members and procedures for presenting evidence, conducting discussion and formulating recommendations. Methods Longitudinal observation of the meetings of three National Institute of Health and Clinical Excellence (NICE GDGs, one from each of acute, mental health and public health, will be tape recorded and transcribed. Interviews with a sample of GDG members at the beginning, middle, and end of the GDG's work will be recorded and transcribed. Site documents including relevant e-mail interchanges, GDG meeting minutes, and stakeholders' responses to the drafts of the recommendations will be collected. Data will be selected for analysis if they refer to either evidence or recommendations; the focus is on "hot spots", e.g., dilemmas, conflicts, and uncertainty. Data will be analysed thematically

  3. Weight Care Project: Health professionals' attitudes and ability to assess body weight status - Study protocol

    Directory of Open Access Journals (Sweden)

    Murphy Kathy

    2011-03-01

    Full Text Available Abstract Background Health professionals working in primary care and public health have opportunities to address body weight status issues with their patients through face-to-face contact. The objectives of this all-Ireland project are: 1. to assess the attitudes, current practices/behaviours and knowledge of key health professional groups on body weight status; 2. to assess the health professional groups' ability to identify body weight status in both adults and children. The health professional groups are: (a community related public health nurses; (b school public health nurses; (c GPs and practice nurses (primary care; and (d occupational health nurses (workplace from both Northern Ireland and the Republic of Ireland. Methods/Design This all-Ireland multi-disciplinary project follows a mixed methods approach using both quantitative and qualitative methodologies, and consists of four components: 1. Literature review - to explore the role of health professionals in managing obesity through spontaneous intervention in a variety of health promotion settings. 2. Telephone interviews and focus groups - to gain an in-depth insight into the views of health professionals in assessing body weight status. 3. Survey (primarily online but also paper-based - to determine the attitudes, current practices/behaviours and knowledge of health professionals in assessing body weight status. 4. Online evaluation study - an online interactive programme will be developed to assess health professionals' ability to identify the body weight status of adults and children. Discussion This project will assess and report the attitudes, current practices/behaviours and knowledge of key health professional groups within Northern Ireland and the Republic of Ireland on body weight status, and their ability to identify body weight status in both adults and children. The results of this project will generate recommendations for clinical practice in managing obesity, which may

  4. Study protocol: home-based telehealth stroke care: a randomized trial for veterans

    Directory of Open Access Journals (Sweden)

    McGee-Hernandez Nancy

    2010-06-01

    Full Text Available Abstract Background Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This trial examines a multifaceted telerehabilitation (TR intervention that uses telehealth technology to simultaneously evaluate the home environment, assess the patient's mobility skills, initiate rehabilitative treatment, prescribe exercises tailored for stroke patients and provide periodic goal oriented reassessment, feedback and encouragement. Methods We describe an ongoing Phase II, 2-arm, 3-site randomized controlled trial (RCT that determines primarily the effect of TR on physical function and secondarily the effect on disability, falls-related self-efficacy, and patient satisfaction. Fifty participants with a diagnosis of ischemic or hemorrhagic stroke will be randomly assigned to one of two groups: (a TR; or (b Usual Care. The TR intervention uses a combination of three videotaped visits and five telephone calls, an in-home messaging device, and additional telephonic contact as needed over a 3-month study period, to provide a progressive rehabilitative intervention with a treatment goal of safe functional mobility of the individual within an accessible home environment. Dependent variables will be measured at baseline, 3-, and 6-months and analyzed with a linear mixed-effects model across all time points. Discussion For patients recovering from stroke, the use of TR to provide home assessments and follow-up training in prescribed equipment has the potential to effectively supplement existing home health services, assist transition to home and

  5. Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project

    Directory of Open Access Journals (Sweden)

    Oberklaid Frank

    2010-12-01

    Full Text Available Abstract Background Up to 70% of children with Attention-Deficit/Hyperactivity Disorder (ADHD experience sleep problems including difficulties initiating and maintaining sleep. Sleep problems in children with ADHD can result in poorer child functioning, impacting on school attendance, daily functioning and behaviour, as well as parental mental health and work attendance. The Sleeping Sound with ADHD trial aims to investigate the efficacy of a behavioural sleep program in treating sleep problems experienced by children with ADHD. We have demonstrated the feasibility and the acceptability of this treatment program in a pilot study. Methods/Design This randomised controlled trial (RCT is being conducted with 198 children (aged between 5 to 12 years with ADHD and moderate to severe sleep problems. Children are recruited from public and private paediatric practices across the state of Victoria, Australia. Upon receiving informed written consent, families are randomised to receive either the behavioural sleep intervention or usual care. The intervention consists of two individual, face-to-face consultations and a follow-up phone call with a trained clinician (trainee consultant paediatrician or psychologist, focusing on the assessment and management of child sleep problems. The primary outcome is parent- and teacher-reported ADHD symptoms (ADHD Rating Scale IV. Secondary outcomes are child sleep (actigraphy and parent report, behaviour, daily functioning, school attendance and working memory, as well as parent mental health and work attendance. We are also assessing the impact of children's psychiatric comorbidity (measured using a structured diagnostic interview on treatment outcome. Discussion To our knowledge, this is the first RCT of a behavioural intervention aiming to treat sleep problems in children with ADHD. If effective, this program will provide a feasible non-pharmacological and acceptable intervention improving child sleep and ADHD

  6. Effectiveness of proactive telephone counselling for smoking cessation in parents: Study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bricker Jonathan B

    2011-09-01

    Full Text Available Abstract Background Smoking is the world's fourth most common risk factor for disease, the leading preventable cause of death, and it is associated with tremendous social costs. In the Netherlands, the smoking prevalence rate is high. A total of 27.7% of the population over age 15 years smokes. In addition to the direct advantages of smoking cessation for the smoker, parents who quit smoking may also decrease their children's risk of smoking initiation. Methods/Design A randomized controlled trial will be conducted to evaluate the effectiveness of proactive telephone counselling to increase smoking cessation rates among smoking parents. A total of 512 smoking parents will be proactively recruited through their children's primary schools and randomly assigned to either proactive telephone counselling or a control condition. Proactive telephone counselling will consist of up to seven counsellor-initiated telephone calls (based on cognitive-behavioural skill building and Motivational Interviewing, distributed over a period of three months. Three supplementary brochures will also be provided. In the control condition, parents will receive a standard brochure to aid smoking cessation. Assessments will take place at baseline, three months after start of the intervention (post-measurement, and twelve months after start of the intervention (follow-up measurement. Primary outcome measures will include sustained abstinence between post-measurement and follow-up measurement and 7-day point prevalence abstinence and 24-hours point prevalence abstinence at both post- and follow-up measurement. Several secondary outcome measures will also be included (e.g., smoking intensity, smoking policies at home. In addition, we will evaluate smoking-related cognitions (e.g., attitudes towards smoking, social norms, self-efficacy, intention to smoke in 9-12 year old children of smoking parents. Discussion This study protocol describes the design of a randomized

  7. FUNGAL CORNEAL ULCERS: A PROSPECTIVE STUDY ON THE CAUSATIVE FUNGUS AND THE RESPONSE TO THE PRESENT TREATMENT PROTOCOL

    Directory of Open Access Journals (Sweden)

    Jisha

    2016-04-01

    Full Text Available BACKGROUND Fungal keratitis is a significant cause of ocular morbidity and unilateral blindness worldwide. The incidence varies with various geographical location and is more common in tropical countries. They are the predominant type of infective corneal ulcers in South India. Identifying the fungal spectrum in each geographical location may help to choose the initial treatment. Aim of the study was to identify spectrum of fungi, to assess the response to the standard treatment given and to find out the sensitivity and specificity of KOH preparation in clinically diagnosed fungal corneal ulcers in patients attending a tertiary care centre in Kerala. METHODS All patients who are clinically diagnosed to have fungal corneal ulcer, based on history and slit lamp findings over a period of 2 years were included in the study. All patients were subjected to corneal scraping and the material is examined by KOH mounting and specific culture techniques as per standard microbiological techniques. The ulcer is treated as per the standard treatment protocol followed in the institution and the response to treatment was analysed. Out of the total 81 patients, Males predominated (n=57. KOH positivity was seen in 27 cases. The fungus culture was positive in 33 cases (41%. The sensitivity of KOH was 45.45% and specificity of 75%. The most common fungus isolated was Fusarium (72.72% followed by Aspergillus (27.27%. The response to the treatment was good for cases in which Fusarium (75% and Penicillium (100% were isolated. The response to the treatment was poor in cases in which the culture report was negative; 56.25% cases developed complications. CONCLUSIONS Among the clinically diagnosed fungal corneal ulcer cases, 40% was found to be culture positive. The KOH preparation has a sensitivity of 45.45% in detecting fungus in mycotic corneal ulcers, whereas the specificity is 75%. Fusarium was the predominant fungus isolated. The response to the standard treatment

  8. Protocol of the baseline assessment for the Environments for Healthy Living (EHL Wales cohort study

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    Dunstan Frank

    2010-03-01

    Full Text Available Abstract Background Health is a result of influences operating at multiple levels. For example, inadequate housing, poor educational attainment, and reduced access to health care are clustered together, and are all associated with reduced health. Policies which try to change individual people's behaviour have limited effect when people have little control over their environment. However, structural environmental change and an understanding of the way that influences interact with each other, has the potential to facilitate healthy choices irrespective of personal resources. The aim of Environments for Healthy Living (EHL is to investigate the impact of gestational and postnatal environments on health, and to examine where structural change can be brought about to optimise health outcomes. The baseline assessment will focus on birth outcomes and maternal and infant health. Methods/Design EHL is a longitudinal birth cohort study. We aim to recruit 1000 pregnant women in the period April 2010 to March 2013. We will examine the impact of the gestational environment (maternal health and the postnatal environment (housing and neighbourhood conditions on subsequent health outcomes for the infants born to these women. Data collection will commence during the participants' pregnancy, from approximately 20 weeks gestation. Participants will complete a questionnaire, undergo anthropometric measurements, wear an accelerometer, compile a food diary, and have environmental measures taken within their home. They will also be asked to consent to having a sample of umbilical cord blood taken following delivery of their baby. These data will be complemented by routinely collected electronic data such as health records from GP surgeries, hospital admissions, and child health and development records. Thereafter, participants will be visited annually for follow-up of subsequent exposures and child health outcomes. Discussion The baseline assessment of EHL will

  9. The childbearing health and related service needs of newcomers (CHARSNN study protocol

    Directory of Open Access Journals (Sweden)

    Saucier Jean-François

    2006-12-01

    Full Text Available Abstract Background Refugee and asylum-seeking women in Canada may have significant harmful childbearing health outcomes and unmet health and social care needs. The most vulnerable of these women are: those who have left their countries by force (e.g., war, rape or abuse histories, are separated from their families, have limited knowledge of the host country languages, and are visible minorities. Asylum-seekers face additional stresses related to their unknown future status and are marginalized with regards to access to provincial health care systems. The prevalence and severity of health issues in this population is not known nor is the extent of response from social service and health care systems (including variation in provincial service delivery. Understanding the magnitude of health and social concerns of newcomers requires data from a representative sample of childbearing refugee and asylum-seeking women resettling in Canada to permit comparisons to be made with non-refugee immigrant and Canadian-born women. Our research questions are: (1 Do refugee or asylum-seeking women and their infants, experience a greater number or a different distribution of harmful health events during pregnancy, at birth, and during the postpartum period than non-refugee immigrant or Canadian-born women? (2 Are the harmful health events experienced postpartum by asylum-seeking women and their infants, addressed less often (compared to refugees, non-refugee immigrants, and Canadian-born women by the Canadian health care system as delivered in each of the three major receiving cities for newcomers? Methods/design This is a four-year multi-site prospective cohort study (pregnancy to 4 months postpartum. We will seek to recruit 2400 women [200 in each of 4 groups (refugees, asylum-seekers, non-refugee immigrants, and Canadian-born from 1 of 12 postpartum hospital units across the 3 largest receiving cities for newcomers to Canada – Montreal, Toronto, and Vancouver

  10. A comparative study on the energy policies in Japan and Malaysia in fulfilling their nations' obligations towards the Kyoto Protocol

    International Nuclear Information System (INIS)

    Global warming and the associated changes in the world climate pattern have been accepted world wide as the gravest threat to humanity in the 20th century. To mitigate the impacts of global warming, the Kyoto Protocol was established in 1997 with the objective of reducing global greenhouse gases (GHGs) emission, in particular carbon dioxide (CO2), by 5.2% below 1990 levels. Developed nations that ratified the Protocol are committed to GHG reduction targets while developing nations are encouraged to reduce GHG emissions on a voluntary basis. Since most of the GHGs emissions come from the energy sector, energy policy plays an important role in fulfilling the Kyoto Protocol obligations. This year marks the beginning of the commitment period for the 2012 Kyoto Protocol. In this case, it would be worthwhile to compare the energy policies in Malaysia and Japan as these nations move towards fulfilling their obligations towards the Kyoto Protocol; bearing in mind that both countries ratified the Protocol, but that Japan commits a reduction target of 6% while Malaysia bears no obligation. Based on the comparison, recommendations were made on how a developing nation like Malaysia could adopt the policies implemented in Japan to suit local conditions and contribute significantly to GHG reduction.

  11. Protocol of study and pursuit of the radioinduced burns; Protocolo de estudio y seguimiento de las quemaduras radioinducidas

    Energy Technology Data Exchange (ETDEWEB)

    Portas, Mercedes; Glustein, Daniel; Pomerane, Armando; Peragallo, Mabel; Guzman, Alejandra; Ciordia, Irma [Hospital de Quemados de Buenos Aires (Argentina). Comite de Radiopatologia; Genovese, Jorge [Laboratorio Craveri, Buenos Aires (Argentina). Dept. de Ingenieria de Tejidos; Cymberknoh, Manuel [Centro de Investigaciones Mamarias, Buenos Aires (Argentina). Dept. de Teletermografia; Dubner, Diana; Michelin, Severino; Perez, Maria del Rosario; Trano, Jose Luis Di; Gisone, Pablo [Autoridad Regulatoria Nuclear, Buenos Aires (Argentina). Lab. de Radiopatologia

    2001-07-01

    A study of localized overexposures based on local experience and international criteria is being carried out within the framework of a cooperation agreement between the Buenos Aires Burned Hospital and the Nuclear Regulatory Authority. This protocol was designed considering separately acute and chronic reactions, including the following aspects: patient reception: clinical findings, laboratory tests, photographic recording, and multidisciplinary evaluation; dose reconstruction: evaluation of the dose distribution by biophysical and biological procedures; extension and depth estimation: telethermography, computed tomography, magnetic resonance, radioisotopic procedures, capillaroscopy and percutaneous oxymetry; therapeutic strategies: pain treatment, prevention of infections, systemic administration of pentoxiphyllin and alpha-tocopherol, local application of trolamine and antioxidants, prevention and treatment of radioinduced fibrosis. When it is indicated, surgical treatment includes partial or total excision followed by covering by graft or flap. The application of tissue-engineering techniques will be considered. Study of individual radiosensitivity: evaluation of apoptosis in peripheral lymphocytes and clonogenic assays in dermal fibroblasts 'in vitro' irradiated. (author)

  12. Protocol of Taste and See: A Feasibility Study of a Church-Based, Healthy, Intuitive Eating Programme

    Directory of Open Access Journals (Sweden)

    Deborah Lycett

    2016-04-01

    Full Text Available Obesity treatment remains a high global priority. Evidence suggests holistic approaches, which include a religious element, are promising. Most research is from the USA, but recent evidence suggests a need within the UK population. The aim of this study is to explore the feasibility of running and evaluating a Christian-based, healthy, intuitive-eating programme, in a UK church. This is the protocol of a mixed-methods single-group feasibility study of a ten-week programme. The programme focuses on breaking the “diet and weight regain” cycle using principles from intuitive eating uniquely combined with biblical principles of love, freedom, responsibility, forgiveness, and spiritual need. We will recruit at least ten adult participants who are obese, overweight, or of a healthy weight with problematic eating behaviours. Participants can be from any faith or none. Robust measures of physical, psychological and spiritual outcomes will be used. Results are not yet available. Findings will be used to design a cluster-randomised controlled trial to test efficacy through many churches. If weight reduces by a small amount, there will be substantial benefits to public health. With a strong association between obesity and mental-ill health, a holistic intervention is particularly important. Using churches addresses religious and spiritual health, and uses existing social structures and a voluntary workforce that are sustainable and cost-effective.

  13. Do physician outcome judgments and judgment biases contribute to inappropriate use of treatments? Study protocol

    Directory of Open Access Journals (Sweden)

    Lott Alison

    2007-06-01

    Full Text Available Abstract Background There are many examples of physicians using treatments inappropriately, despite clear evidence about the circumstances under which the benefits of such treatments outweigh their harms. When such over- or under- use of treatments occurs for common diseases, the burden to the healthcare system and risks to patients can be substantial. We propose that a major contributor to inappropriate treatment may be how clinicians judge the likelihood of important treatment outcomes, and how these judgments influence their treatment decisions. The current study will examine the role of judged outcome probabilities and other cognitive factors in the context of two clinical treatment decisions: 1 prescription of antibiotics for sore throat, where we hypothesize overestimation of benefit and underestimation of harm leads to over-prescription of antibiotics; and 2 initiation of anticoagulation for patients with atrial fibrillation (AF, where we hypothesize that underestimation of benefit and overestimation of harm leads to under-prescription of warfarin. Methods For each of the two conditions, we will administer surveys of two types (Type 1 and Type 2 to different samples of Canadian physicians. The primary goal of the Type 1 survey is to assess physicians' perceived outcome probabilities (both good and bad outcomes for the target treatment. Type 1 surveys will assess judged outcome probabilities in the context of a representative patient, and include questions about how physicians currently treat such cases, the recollection of rare or vivid outcomes, as well as practice and demographic details. The primary goal of the Type 2 surveys is to measure the specific factors that drive individual clinical judgments and treatment decisions, using a 'clinical judgment analysis' or 'lens modeling' approach. This survey will manipulate eight clinical variables across a series of sixteen realistic case vignettes. Based on the survey responses, we will be

  14. Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol.

    Science.gov (United States)

    Moller, David R; Koth, Laura L; Maier, Lisa A; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K; Collman, Ronald G; Hamzeh, Nabeel; Sweiss, Nadera J; Zhang, Yingze; O'Neal, Scott; Senior, Robert M; Becich, Michael; Hochheiser, Harry S; Kaminski, Naftali; Wisniewski, Stephen R; Gibson, Kevin F

    2015-10-01

    Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant's clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis.

  15. Function, Adjustment, Quality of Life and Symptoms (FAQS in Allogeneic Hematopoietic Stem Cell Transplantation (HSCT Survivors: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Krumlauf Michael

    2011-04-01

    Full Text Available Abstract Background The population of survivors following allogeneic HSCT continues to increase, and yet their experiences of recovery and long-term survivorship have not been fully characterized. This paper presents a study protocol examining over time the functional status, psychosocial adjustment, health-related quality of life, and symptom experience of survivors who have undergone allogeneic transplantation. The aims of the study are to: 1 explore the patterns of change in these health outcomes during the survivorship phase; 2 characterize subgroups of survivors experiencing adverse outcomes; and 3 examine relationships among outcomes and demographic and clinical factors (such as age, graft-versus-host disease (GVHD, and disease relapse. Methods In this longitudinal observational study, adults who survive a minimum of 3 years from date of allogeneic transplantation complete a series of questionnaires annually. Demographic and clinical data are collected along with a series of patient-reported outcome measures, specifically: 1 Medical Outcomes Study SF- 36; 2 Functional Assessment of Chronic Illness Therapy (FACIT - General, 3 FACIT-Fatigue; 4 FACIT- Spiritual; 5 Psychosocial Adjustment to Illness Scale; 6 Rotterdam Symptom Checklist-Revised; and 7 Pittsburgh Sleep Quality Index. Conclusions This study will provide multidimensional patient-reported outcomes data to expand the understanding of the survivorship experience across the trajectory of allogeneic transplantation recovery. There are a number of inherent challenges in recruiting and retaining a diverse and representative sample of long-term transplant survivors. Study results will contribute to an understanding of outcomes experienced by transplant survivors, including those with chronic GVHD, malignant disease relapse, and other late effects following allogeneic transplantation. Trial Registration ClinicalTrials.gov: NCT00128960

  16. 电子商务安全协议分析%Research on the Situation of E - Commerce and Study on Security Protocol

    Institute of Scientific and Technical Information of China (English)

    沈二波

    2012-01-01

    This paper analyzes the course of Electronic Commerce, studies the present situation of security of E commerce and argues that tile network payment security is the main bottleneck during the development of E commerce. As the key factors affecting the secu rity of network payment is Network Protocol, this paper analyzes and compares the security of two protocols, then verifies that using SSL is more secure than using http.%对两种常见网络协议的结构进行了分析与比较,通过实际网络环境操作,验证了SSL协议的安全性.

  17. A collaborative study on a Nordic standard protocol for detection and enumeration of thermotolerant Campylobacter in food (NMKL 119, 3. Ed., 2007)

    DEFF Research Database (Denmark)

    Rosenquist, Hanne; Bengtsson, Anja; Hansen, Tina Beck

    2007-01-01

    A Nordic standard protocol for detection and enumeration of thermotolerant Campylobacter in food has been elaborated (NMKL 119, 3. Ed., 2007). Performance and precision characteristics of this protocol were evaluated in a collaborative study with participation of 14 laboratories from seven European.......4-86.6%), respectively. The sensitivity was not influenced by food matrix (P=0.359), but was significantly lower for C. coli compared to C. jejuni (P= 0.007) and for concentrations below 1.4 cfu g(-1) (P

  18. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU

    Science.gov (United States)

    Bonini, Sara; Maffia, Sara; Molatore, Katia; Sebastianelli, Luca; Zarucchi, Alessio; Matteri, Diana; Ercoli, Giuseppe; Maestri, Roberto

    2016-01-01

    Background and Objective Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. We evaluated the effectiveness of a very early stepping verticalization protocol on their functional and neurological outcome. Methods Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to our Neurorehabilitation unit for an individualized treatment. Outcome measures (Glasgow Coma Scale, Coma Recovery Scale revised -CRSr-, Disability Rating Scale–DRS- and Levels of Cognitive Functioning) were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2). Between- and within-group comparisons were performed by the Mann-Whitney U test and Wilcoxon signed-rank test, respectively. Results Of the 40 patients enrolled, 31 completed the study without adverse events (15 in the verticalization group and 16 in the conventional physiotherapy). Early verticalization started 12.4±7.3 (mean±SD) days after ABI. The length of stay in ICU was longer for the verticalization group (38.8 ± 15.7 vs 25.1 ± 11.2 days, p = 0.01), while the total length of stay (ICU+Neurorehabilitation) was not significantly different (153.2 ± 59.6 vs 134.0 ± 61.0 days, p = 0.41). All outcome measures significantly improved in both groups after the overall period (T2 vs T0, p<0.001 all), as well as after ICU stay (T1 vs T0, p<0.004 all) and after Neurorehabilitation (T2 vs T1, p<0.004 all). The improvement was significantly better in the experimental group for CRSr (T2-T0 p = 0.033, T1-T0 p = 0.006) and (borderline) for DRS (T2-T0 p = 0.040, T1-T0 p = 0.058). Conclusions A stepping verticalization

  19. Novel analysis and improvement of Yahalom protocol

    Institute of Scientific and Technical Information of China (English)

    CHEN Chun-ling; YU Han; L(U) Heng-shan; WANG Ru-chuan

    2009-01-01

    The modified version of Yahalom protocol improved by Burrows, Abradi, and Needham (BAN) still has security drawbacks. This study analyzed such flaws in a detailed way from the point of strand spaces, which is a novel method of analyzing protocol's security. First, a mathematical model of BAN-Yahalom protocol is constructed. Second, penetrators' abilities are restricted with a rigorous and formalized definition. Moreover, to increase the security of this protocol against potential attackers in practice, a further improvement is made to the protocol. Future application of this re-improved protocol is also discussed.

  20. Analysis of Requirements for the Medication Profile to Be Used in Clinical Research: Protocol Feasibility Studies and Patient Recruitment

    Directory of Open Access Journals (Sweden)

    Julie M. James

    2015-01-01

    Full Text Available A “Medication Profile,” the information about the medicines a person is using and has used, is a core part of many electronic health record systems and summaries. However, there is little objective research into the data elements that the profile should contain to support the uses it must serve. With the increasing emphasis on secondary uses of electronic health information, as well as supporting the requirements to support direct to patient care, the Medication Profile should also support the requirements from clinical research. However, there is little, if any, description of these available. This paper describes an analysis of a set of study eligibility criteria that was undertaken to investigate which medication-related data elements would be required to support two clinical research use cases: the parameters to query a patient’s Medication Profile to assess their suitability for entry into a trial (patient recruitment and the parameters to query a set of Medication Profiles in a data warehouse to assess whether the eligibility criteria as described would yield a reasonable cohort of patients as potential subjects (protocol feasibility. These medication-related data elements then become information requirements that a Medication Profile should ideally meet, in order to be able to support these two uses in the clinical research domain.

  1. Preliminary pilot fMRI study of neuropostural optimization with a noninvasive asymmetric radioelectric brain stimulation protocol in functional dysmetria

    Directory of Open Access Journals (Sweden)

    Mura M

    2012-04-01

    Full Text Available Marco Mura1, Alessandro Castagna2, Vania Fontani2, Salvatore Rinaldi21Institute of Radiology, University of Cagliari, 2Rinaldi Fontani Institute – Department of Neuro Psycho Physical Optimization, Florence, ItalyPurpose: This study assessed changes in functional dysmetria (FD and in brain activation observable by functional magnetic resonance imaging (fMRI during a leg flexion-extension motor task following brain stimulation with a single radioelectric asymmetric conveyer (REAC pulse, according to the precisely defined neuropostural optimization (NPO protocol.Population and methods: Ten healthy volunteers were assessed using fMRI conducted during a simple motor task before and immediately after delivery of a single REAC-NPO pulse. The motor task consisted of a flexion-extension movement of the legs with the knees bent. FD signs and brain activation patterns were compared before and after REAC-NPO.Results: A single 250-millisecond REAC-NPO treatment alleviated FD, as evidenced by patellar asymmetry during a sit-up motion, and modulated activity patterns in the brain, particularly in the cerebellum, during the performance of the motor task.Conclusion: Activity in brain areas involved in motor control and coordination, including the cerebellum, is altered by administration of a REAC-NPO treatment and this effect is accompanied by an alleviation of FD.Keywords: motor behavior, motor control, cerebellum, dysmetria, functional dysmetria, fluctuating asymmetry

  2. Study protocol for the World Health Organization project to develop a Quality of Life assessment instrument (WHOQOL).

    Science.gov (United States)

    1993-04-01

    The World Health Organization (WHO) has undertaken a project to develop an instrument (the WHOQOL) for measuring quality of life. Quality of life is defined as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by the person's physical health, psychological state, level of independence, social relationships, and their relationship to salient features of their environment. The instrument will be developed in the framework of a collaborative project involving numerous centres in different cultural settings. In addition, it will have proven psychometric properties of validity, responsiveness and reliability and will be sensitive to the cultural setting in which it is applied, whilst maintaining comparability of scores across different cultural settings. This paper outlines the characteristics of the planned instrument and the study protocol governing work on its development. To date steps 1 through 5 have been completed and work is progressing on step 6. It is anticipated that the instrument will be available for piloting in July 1993 and a final version available for use in June 1994. PMID:8518769

  3. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McColl Elaine

    2011-06-01

    Full Text Available Abstract Background High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective. The earliest that acute stroke treatments could be initiated is during contact with the emergency medical services (paramedics. However, experience of pre-hospital clinical trials is limited and logistical challenges are likely to be greater than for trials performed in other settings. We report the protocol for a pilot randomised controlled trial of paramedic initiated blood pressure lowering treatment for hypertension in acute stroke. Methods Trial Design: Double blind parallel group external pilot randomised controlled trial. Setting: Participant recruitment and initial treatment by North East Ambulance Service research trained paramedics responding to the emergency call. Continued treatment in three study hospitals. Participants: Target is recruitment of 60 adults with acute arm weakness due to suspected stroke (within 3 hours of symptom onset and hypertension (systolic BP>160 mmHg. Intervention: Lisinopril 5-10 mg (intervention group, matched placebo (control group, daily for 7 days. Randomisation: Study medication contained within identical pre-randomised "trial packs" carried by research trained paramedics. Outcomes: Study feasibility (recruitment rate, compliance with data collection and clinical data to inform the design of a definitive randomised controlled trial (blood pressure monitoring, National Institute of Health Stroke Scale, Barthel ADL Index, Modified Rankin Scale, renal function. Discussion This pilot study is assessing the feasibility of a randomised controlled trial of paramedic initiated lisinopril for hypertension early after the onset of acute stroke. The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke

  4. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial

    NARCIS (Netherlands)

    Groot, J.J.A.M. de; Maessen, J.M.; Slangen, B.F.; Winkens, B.; Dirksen, C.D.; Weijden, T.T. van der

    2015-01-01

    BACKGROUND: Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological

  5. Development of new method and protocol for cryopreservation related to embryo and oocytes freezing in terms of fertilization rate: A comparative study including review of literature

    Directory of Open Access Journals (Sweden)

    Mayadhar Barik

    2016-01-01

    Conclusions: We ensure that cryopreservation technology provided useful cell survivability, tissue and organ preservation in a proper way. Although it varies according to different laboratory conditions, it is certainly beneficial for patient′s treatment and research. Further studies are needed for standardization and development of new protocol.

  6. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    NARCIS (Netherlands)

    M. Pradhan; S.A. Brinkman; A. Beatty; A. Maika; E. Satriawan; J. de Ree; A. Hasan

    2013-01-01

    Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program w

  7. Analyzing the effect of routing protocols on media access control protocols in radio networks

    Energy Technology Data Exchange (ETDEWEB)

    Barrett, C. L. (Christopher L.); Drozda, M. (Martin); Marathe, A. (Achla); Marathe, M. V. (Madhav V.)

    2002-01-01

    We study the effect of routing protocols on the performance of media access control (MAC) protocols in wireless radio networks. Three well known MAC protocols: 802.11, CSMA, and MACA are considered. Similarly three recently proposed routing protocols: AODV, DSR and LAR scheme 1 are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of our experiments was to study how the routing protocols affect the performance of the MAC protocols when the underlying network and traffic parameters are varied. The performance of the protocols was measured w.r.t. five important parameters: (i) number of received packets, (ii) average latency of each packet, (iii) throughput (iv) long term fairness and (v) number of control packets at the MAC layer level. Our results show that combinations of routing and MAC protocols yield varying performance under varying network topology and traffic situations. The result has an important implication; no combination of routing protocol and MAC protocol is the best over all situations. Also, the performance analysis of protocols at a given level in the protocol stack needs to be studied not locally in isolation but as a part of the complete protocol stack. A novel aspect of our work is the use of statistical technique, ANOVA (Analysis of Variance) to characterize the effect of routing protocols on MAC protocols. This technique is of independent interest and can be utilized in several other simulation and empirical studies.

  8. EFFICIENCY AND EFFECTIVENESS ANALYSIS OVER ECC-BASED DIRECT AND INDIRECT AUTHENTICATION PROTOCOLS: AN EXTENSIVE COMPARATIVE STUDY

    Directory of Open Access Journals (Sweden)

    K. Thilagavathi

    2012-03-01

    Full Text Available Elliptic curve cryptography finds enormous applications because of its security offering using the remarkable property of elliptic curve. The Elliptic curve cryptography finds enormous applications in almost all the emerging areas. However in mobile networks, the usage of elliptic curve cryptography is limited. Moreover, the operation of mobile networks in an un-trusted environment increases the significance of the usage of security protocols. To provide a secure environment, an improved authentication protocols are required as the menacing effects increasing. Hence, in the previous works, we have proposed two authentication protocols. One of the protocols performs direct authentication and the other one performs indirect authentication. However, the performance of both of them has to be analyzed. Hence in this paper, a comparative analysis is made between the two authentication protocols. The analysis is done empirically as well experimentally. For performance analysis, the efficiency measures such as computational overhead, communication overhead, storage overhead and total computational complexity and the effectiveness measures such as replay attack, guessing attack and Stolen-Verifier attack are considered.

  9. Sources of Variation in a Two-Step Monitoring Protocol for Species Clustered in Conspicuous Points: Dolichotis patagonum as a Case Study.

    Science.gov (United States)

    Alonso Roldán, Virginia; Bossio, Luisina; Galván, David E

    2015-01-01

    In species showing distributions attached to particular features of the landscape or conspicuous signs, counts are commonly made by making focal observations where animals concentrate. However, to obtain density estimates for a given area, independent searching for signs and occupancy rates of suitable sites is needed. In both cases, it is important to estimate detection probability and other possible sources of variation to avoid confounding effects on measurements of abundance variation. Our objective was to assess possible bias and sources of variation in a two-step protocol in which random designs were applied to search for signs while continuously recording video cameras were used to perform abundance counts where animals are concentrated, using mara (Dolichotis patagonum) as a case study. The protocol was successfully applied to maras within the Península Valdés protected area, given that the protocol was logistically suitable, allowed warrens to be found, the associated adults to be counted, and the detection probability to be estimated. Variability was documented in both components of the two-step protocol. These sources of variation should be taken into account when applying this protocol. Warren detectability was approximately 80% with little variation. Factors related to false positive detection were more important than imperfect detection. The detectability for individuals was approximately 90% using the entire day of observations. The shortest sampling period with a similar detection capacity than a day was approximately 10 hours, and during this period, the visiting dynamic did not show trends. For individual mara, the detection capacity of the camera was not significantly different from the observer during fieldwork. The presence of the camera did not affect the visiting behavior of adults to the warren. Application of this protocol will allow monitoring of the near-threatened mara providing a minimum local population size and a baseline for

  10. Sources of Variation in a Two-Step Monitoring Protocol for Species Clustered in Conspicuous Points: Dolichotis patagonum as a Case Study.

    Directory of Open Access Journals (Sweden)

    Virginia Alonso Roldán

    Full Text Available In species showing distributions attached to particular features of the landscape or conspicuous signs, counts are commonly made by making focal observations where animals concentrate. However, to obtain density estimates for a given area, independent searching for signs and occupancy rates of suitable sites is needed. In both cases, it is important to estimate detection probability and other possible sources of variation to avoid confounding effects on measurements of abundance variation. Our objective was to assess possible bias and sources of variation in a two-step protocol in which random designs were applied to search for signs while continuously recording video cameras were used to perform abundance counts where animals are concentrated, using mara (Dolichotis patagonum as a case study. The protocol was successfully applied to maras within the Península Valdés protected area, given that the protocol was logistically suitable, allowed warrens to be found, the associated adults to be counted, and the detection probability to be estimated. Variability was documented in both components of the two-step protocol. These sources of variation should be taken into account when applying this protocol. Warren detectability was approximately 80% with little variation. Factors related to false positive detection were more important than imperfect detection. The detectability for individuals was approximately 90% using the entire day of observations. The shortest sampling period with a similar detection capacity than a day was approximately 10 hours, and during this period, the visiting dynamic did not show trends. For individual mara, the detection capacity of the camera was not significantly different from the observer during fieldwork. The presence of the camera did not affect the visiting behavior of adults to the warren. Application of this protocol will allow monitoring of the near-threatened mara providing a minimum local population size and a

  11. How to Find Lessons from the Public Health Literature: Example of a Scoping Study Protocol on the Neighborhood Environment

    Science.gov (United States)

    Levasseur, Mélanie; Généreux, Mélissa; Desroches, Josiane; Carrier, Annie; Lacasse, Francis; Chabot, Éric; Abecia, Ana; Gosselin, Louise; Vanasse, Alain

    2016-01-01

    Background: As key determinants of many favorable health and quality of life outcomes, it is important to identify factors associated with mobility and social participation. Although several investigations have been carried out on mobility, social participation and neighborhood environment, there is no clear integration of these results. This paper presents a scoping study protocol that aims to provide a comprehensive understanding of how the physical and social neighborhood environment is associated with or influences mobility and social participation in older adults. Methods: The rigorous methodological framework for scoping studies is used to synthesize and disseminate current knowledge on the associations or influence of the neighborhood environment on mobility and social participation in aging. Nine databases from public health and other fields are searched with 51 predetermined keywords. Using content analysis, all data are exhaustively analyzed, organized, and synthesized independently by two research assistants. Discussion: A comprehensive synthesis of empirical studies provides decision-makers, clinicians and researchers with current knowledge and best practices regarding neighborhood environments with a view to enhancing mobility and social participation. Such a synthesis represents an original contribution and can ultimately support decisions and development of innovative interventions and clear guidelines for the creation of age-supportive environments. Improvements in public health and clinical interventions might be the new innovation needed to foster health and quality of life for aging population. Finally, the aspects of the associations or influence of the neighborhood environment on mobility and social participation not covered by previous research are identified. Conclusions: Among factors that impact mobility and social participation, the neighborhood environment is important since interventions targeting it may have a greater impact on an

  12. A comparison of pregnancy outcomes in Ghanaian women with varying dietary diversity: a prospective cohort study protocol

    Science.gov (United States)

    Saaka, Mahama; Siassi, Fereydoun; Qorbani, Mostafa; Yavari, Parvaneh; Danquah, Ina; Sotoudeh, Gity

    2016-01-01

    Introduction Poor dietary intake during pregnancy can have negative repercussions on the mother and fetus. This study therefore aims to explore the dietary diversity (DD) of pregnant women and its associations with pregnancy outcomes among women in Northern Ghana. The main outcome variables to be measured are gestational weight gain and birth weight. Methods and analysis A prospective cohort study design will be used and 600 pregnant women in their first trimester will be systematically recruited at health facilities and followed until delivery. In three follow-up visits after recruitment, information on sociodemographic and general characteristics, physical activity (International Physical Activity Questionnaire (IPAQ) short form, dietary intake (24-hour food recall), anthropometry and pregnancy outcomes will be collected. DD will be measured three times using the minimum DD-women (MDD-W) indicator and the mean of the three values overall will be used to determine low (<5 food groups) and high (≥5 food groups) DD. Data will be analysed using SPSS. Comparisons between groups (categorical data) will be made using the χ2 test for proportions, and t-tests and ANOVA will be performed on continuous variables. Regression analysis will be used to identify independent outcome predictors while controlling for possible confounding factors. The results may help to identify differences in DD between healthy and unhealthy pregnancy outcomes. Ethics and dissemination The study protocol has been approved by the ethics committee of Tehran University of Medical Sciences and the ethical review committee of the Tamale Teaching Hospital. Written informed consent will be obtained from all subjects. The results will be published in due course. PMID:27655259

  13. Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2007-12-01

    Full Text Available Abstract Background Paratonia, a form of hypertonia, is associated with loss of mobility and with the development of contractures especially in the late stages of the dementia. Passive movement therapy (PMT currently is the main physiotherapeutic intervention. General doubt about the beneficial effects of this widely used therapy necessitates a randomised clinical trial (RCT to study the efficacy of PMT on the severity of paratonia and on the improvement of daily care. Methods/Design A RCT with a 4-week follow-up period. Patients with dementia (according to the DSM-IV-TR Criteria and moderate to severe paratonia are included in the study after proxy consent. By means of computerised and concealed block randomisation (block-size of 4 patients are included in one of two groups. The first group receives PMT, the second group receives usual care without PMT. PMT is given according to a protocol by physical therapist three times a week for four weeks in a row. The severity of paratonia (Modified Ashworth scale, the severity of the dementia (Global Deterioration Scale, the clinical improvement (Clinical Global Impressions, the difficulty in daily care (Patient Specific Complaints and the experienced pain in daily care of the participant (PACSLAC-D is assessed by assessors blind to treatment allocation at baseline, after 6 and 12 treatments. Success of the intervention is defined as a significant increase of decline on the modified Ashworth scale. The 'proportion of change' in two and four weeks time on this scale will be analysed. Also a multiple logistic regression analysis using declined/not declined criteria as dependent variable with correction for relevant confounders (e.g. stage of dementia, medication, co-morbidity will be used. Discussion This study is the first RCT of this size to gain further insight on the effect of passive movement therapy on the severity of paratonia. Trial registration Current Controlled Trials ISRCTN43069940

  14. Study protocol: a randomised controlled trial of a theory-based online intervention to improve sun safety among Australian adults

    International Nuclear Information System (INIS)

    The effects of exposure to ultraviolet radiation are a significant concern in Australia which has one of the highest incidences of skin cancer in the world. Despite most skin cancers being preventable by encouraging consistent adoption of sun-protective behaviours, incidence rates are not decreasing. There is a dearth of research examining the factors involved in engaging in sun-protective behaviours. Further, online multi-behavioural theory-based interventions have yet to be explored fully as a medium for improving sun-protective behaviour in adults. This paper presents the study protocol of a randomised controlled trial of an online intervention based on the Theory of Planned Behaviour (TPB) that aims to improve sun safety among Australian adults. Approximately 420 adults aged 18 and over and predominantly from Queensland, Australia, will be recruited and randomised to the intervention (n = 200), information only (n = 200) or the control group (n = 20). The intervention focuses on encouraging supportive attitudes and beliefs toward sun-protective behaviour, fostering perceptions of normative support for sun protection, and increasing perceptions of control/self-efficacy over sun protection. The intervention will be delivered online over a single session. Data will be collected immediately prior to the intervention (Time 1), immediately following the intervention (Time 1b), and one week (Time 2) and one month (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun-protective behaviour. Secondary outcomes are the participants’ attitudes toward sun protection, perceptions of normative support for sun protection (i.e. subjective norms, group norms, personal norms and image norms) and perceptions of control/self-efficacy toward sun protection. The study will contribute to an understanding of the effectiveness of a TPB-based online intervention to improve Australian adults’ sun-protective behaviour. Australian and New Zealand Trials

  15. Evaluating a selective prevention programme for binge drinking among young adolescents: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wiers Reinout

    2011-02-01

    Full Text Available Abstract Background In comparison to other Europe countries, Dutch adolescents are at the top in drinking frequency and binge drinking. A total of 75% of the Dutch 12 to 16 year olds who drink alcohol also engage in binge drinking. A prevention programme called Preventure was developed in Canada to prevent adolescents from binge drinking. This article describes a study that aims to assess the effects of this selective school-based prevention programme in the Netherlands. Methods A randomized controlled trial is being conducted among 13 to 15-year-old adolescents in secondary schools. Schools were randomly assigned to the intervention and control conditions. The intervention condition consisted of two 90 minute group sessions, carried out at the participants' schools and provided by a qualified counsellor and a co-facilitator. The intervention targeted young adolescents who demonstrated personality risk for alcohol abuse. The group sessions were adapted to four personality profiles. The control condition received no further intervention above the standard substance use education sessions provided in the Dutch national curriculum. The primary outcomes will be the percentage reduction in binge drinking, weekly drinking and drinking-related problems after three specified time periods. A screening survey collected data by means of an Internet questionnaire. Students have completed, or will complete, a post-treatment survey after 2, 6, and 12 months, also by means of an online questionnaire. Discussion This study protocol presents the design and current implementation of a randomized controlled trial to evaluate the effectiveness of a selective alcohol prevention programme. We expect that a significantly lower number of adolescents will binge drink, drink weekly, and have drinking-related problems in the intervention condition compared to the control condition, as a result of this intervention. Trial registration This trial is registered in the Dutch

  16. Study protocol: a randomised controlled trial investigating the effect of a healthy lifestyle intervention for people with severe mental disorders

    Directory of Open Access Journals (Sweden)

    Castle David

    2011-01-01

    Full Text Available Abstract Background The largest single cause of death among people with severe mental disorders is cardiovascular disease (CVD. The majority of people with schizophrenia and bipolar disorder smoke and many are also overweight, considerably increasing their risk of CVD. Treatment for smoking and other health risk behaviours is often not prioritized among people with severe mental disorders. This protocol describes a study in which we will assess the effectiveness of a healthy lifestyle intervention on smoking and CVD risk and associated health behaviours among people with severe mental disorders. Methods/Design 250 smokers with a severe mental disorder will be recruited. After completion of a baseline assessment and an initial face-to-face intervention session, participants will be randomly assigned to either a multi-component intervention for smoking cessation and CVD risk reduction or a telephone-based minimal intervention focusing on smoking cessation. Randomisation will be stratified by site (Newcastle, Sydney, Melbourne, Australia, Body Mass Index (BMI category (normal, overweight, obese and type of antipsychotic medication (typical, atypical. Participants will receive 8 weekly, 3 fortnightly and 6 monthly sessions delivered face to face (typically 1 hour or by telephone (typically 10 minutes. Assessments will be conducted by research staff blind to treatment allocation at baseline, 15 weeks, and 12-, 18-, 24-, 30- and 36-months. Discussion This study will provide comprehensive data on the effect of a healthy lifestyle intervention on smoking and CVD risk among people with severe mental disorders. If shown to be effective, this intervention can be disseminated to treating clinicians using the treatment manuals. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR identifier: ACTRN12609001039279

  17. 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

    ; as secondary variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS, nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat. Discussion The discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis.

  18. A study protocol for the evaluation of occupational mutagenic/carcinogenic risks in subjects exposed to antineoplastic drugs: a multicentric project

    OpenAIRE

    Gelatti Umberto; Sabatini Laura; Dominici Luca; Appolloni Massimo; Buschini Annamaria; Carrieri Mariella; Ceretti Elisabetta; Barbieri Anna; Villarini Milena; Grollino Maria G; Mussi Francesca; Pavanello Sofia; Feretti Donatella; Bonfiglioli Roberta; Moretti Massimo

    2011-01-01

    Abstract Background Some industrial hygiene studies have assessed occupational exposure to antineoplastic drugs; other epidemiological investigations have detected various toxicological effects in exposure groups labeled with the job title. In no research has the same population been studied both environmentally and epidemiologically. The protocol of the epidemiological study presented here uses an integrated environmental and biological monitoring approach. The aim is to assess in hospital n...

  19. Effects of Study Design and Allocation on participant behaviour - ESDA: study protocol for a randomized controlled trial

    OpenAIRE

    Sheeran Paschal; Attia John; Wilson Amanda; McCambridge Jim; Kypri Kypros; Bowe Steve; Vater Tina

    2011-01-01

    Abstract Background What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. Methods/Design A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participan...

  20. LOng-term follow-up after liVE kidney donation (LOVE) study: A longitudinal comparison study protocol

    OpenAIRE

    Janki, Shiromani; Klop, Karel; Kimenai, F.F.P.; Wetering, Jacqueline; Weimar, Willem; Massey, Emma; Dehghan, Abbas; Rizopoulos, Dimitris; Völzke, Henry; Hofman, Albert; IJzermans, Jan

    2016-01-01

    textabstractBackground: The benefits of live donor kidney transplantation must be balanced against the potential harm to the donor. Well-designed prospective studies are needed to study the long-term consequences of kidney donation. Methods: The "LOng-term follow-up after liVE kidney donation" (LOVE) study is a single center longitudinal cohort study on long-term consequences after living kidney donation. We will study individuals who have donated a kidney from 1981 through 2010 in the Erasmu...

  1. LOng-term follow-up after liVE kidney donation (LOVE) study: a longitudinal comparison study protocol

    OpenAIRE

    Janki, Shiromani; Klop, Karel W. J.; Kimenai, Hendrikus J. A. N.; Wetering, Jacqueline; Weimar, Willem; Massey, Emma K.; Dehghan, Abbas; Rizopoulos, Dimitris; Völzke, Henry; Hofman, Albert; IJzermans, Jan N. M.

    2016-01-01

    Background The benefits of live donor kidney transplantation must be balanced against the potential harm to the donor. Well-designed prospective studies are needed to study the long-term consequences of kidney donation. Methods The “LOng-term follow-up after liVE kidney donation” (LOVE) study is a single center longitudinal cohort study on long-term consequences after living kidney donation. We will study individuals who have donated a kidney from 1981 through 2010 in the Erasmus University M...

  2. LOng-term follow-up after liVE kidney donation (LOVE) study: a longitudinal comparison study protocol

    OpenAIRE

    Janki, Shiromani; Klop, Karel W. J.; Kimenai, Hendrikus J. A. N.; Wetering, Jacqueline; Weimar, Willem; Massey, Emma K.; Dehghan, Abbas; Rizopoulos, Dimitris; Völzke, Henry; Hofman, Albert; IJzermans, Jan N. M.

    2016-01-01

    Background: The benefits of live donor kidney transplantation must be balanced against the potential harm to the donor. Well-designed prospective studies are needed to study the long-term consequences of kidney donation. Methods: The “LOng-term follow-up after liVE kidney donation” (LOVE) study is a single center longitudinal cohort study on long-term consequences after living kidney donation. We will study individuals who have donated a kidney from 1981 through 2010 in the Erasmus University...

  3. Self-Healing Protocol Implementations

    OpenAIRE

    Tschudin, Christian; Yamamoto, Lidia

    2005-01-01

    Current studies on self-configuring and adaptive networks aim at developing specific and fixed protocols which are able to optimize their configuration in a variable network environment. In this talk we study the problem where the protocols need to cope with a defective execution, including the lossy execution or the injection of foreign code. One guiding question will be the creation of robust execution circuits which can distribute over a network and which continue their service despite par...

  4. Mobile internet protocol analysis

    OpenAIRE

    Brachfeld, Lawrence J.

    1999-01-01

    Mobile Internet Protocol (IP) is a proposed standard that builds on the current Internet Protocol by making the fact that a user is mobile transparent to applications and higher level protocols such as Transmission Control Protocol (TCP) and User Datagram Protocol (UDP). Mobile IP allows mobile computers to send and receive packets addressed with their home network IP address, regardless of the IP address of their current point of attachment on the Internet while maintaining any current conne...

  5. Coded Splitting Tree Protocols

    DEFF Research Database (Denmark)

    Sørensen, Jesper Hemming; Stefanovic, Cedomir; Popovski, Petar

    2013-01-01

    This paper presents a novel approach to multiple access control called coded splitting tree protocol. The approach builds on the known tree splitting protocols, code structure and successive interference cancellation (SIC). Several instances of the tree splitting protocol are initiated, each...... as possible. Evaluations show that the proposed protocol provides considerable gains over the standard tree splitting protocol applying SIC. The improvement comes at the expense of an increased feedback and receiver complexity....

  6. Impact of alprazolam in allostatic load and neurocognition of patients with anxiety disorders and chronic stress (GEMA): observational study protocol

    Science.gov (United States)

    Soria, Carlos A; Remedi, Carolina; Núñez, Daniel A; D'Alessio, Luciana; Roldán, Emilio J A

    2015-01-01

    Introduction The allostatic load model explains the additive effects of multiple biological processes that accelerate pathophysiology related to stress, particularly in the central nervous system. Stress-related mental conditions such as anxiety disorders and neuroticism (a well-known stress vulnerability factor), have been linked to disturbances of hypothalamo–pituitary–adrenal with cognitive implications. Nevertheless, there are controversial results in the literature and there is a need to determine the impact of the psychopharmacological treatment on allostatic load parameters and in cognitive functions. Gador study of Estres Modulation by Alprazolam, aims to determine the impact of medication on neurobiochemical variables related to chronic stress, metabolic syndrome, neurocognition and quality of life in patients with anxiety, allostatic load and neuroticism. Methods/analysis In this observational prospective phase IV study, highly sympthomatic patients with anxiety disorders (six or more points in the Hamilton-A scale), neuroticism (more than 18 points in the Neo five personality factor inventory (NEO-FFI) scale), an allostatic load (three positive clinical or biochemical items at Crimmins and Seeman criteria) will be included. Clinical variables of anxiety, neuroticism, allostatic load, neurobiochemical studies, neurocognition and quality of life will be determined prior and periodically (1, 2, 4, 8, and 12 weeks) after treatment (on demand of alprazolam from 0.75 mg/day to 3.0 mg/day). A sample of n=55/182 patients will be considered enough to detect variables higher than 25% (pretreatment vs post-treatment or significant correlations) with a 1-ß power of 0–80. t Test and/or non-parametric test, and Pearson's test for correlation analysis will be determined. Ethics and dissemination This study protocol was approved by an Independent Ethics Committee of FEFyM (Foundation for Pharmacological Studies and Drugs, Buenos Aires) and by regulatory

  7. Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Huppelschoten Aleida G

    2012-09-01

    Full Text Available Abstract Background Beside traditional outcomes of safety and (cost-effectiveness, the Institute of Medicine states patient-centeredness as an independent outcome indicator to evaluate the quality of healthcare. Providing patient-centered care is important because patients want to be heard for their ideas and concerns. Healthcare areas associated with high emotions and intensive treatment periods could especially benefit from patient-centered care. How care can become optimally improved in patient-centeredness is unknown. Therefore, we will conduct a study in the context of Dutch fertility care to determine the effects of a multifaceted approach on patient-centeredness, patients’ quality of life (QoL and levels of distress. Our aims are to investigate the effectiveness of a multifaceted approach and to identify determinants of a change in the level of patient-centeredness, patients’ QoL and distress levels. This paper presents the study protocol. Methods/Design In a cluster-randomized trial in 32 Dutch fertility clinics the effects of a multifaceted approach will be determined on the level of patient-centeredness (Patient-centredness Questionnaire – Infertility, patients’ QoL (FertiQoL and levels of distress (SCREENIVF. The multifaceted approach includes audit and feedback, educational outreach visits and patient-mediated interventions. Potential determinants of a change in patient-centeredness, patients’ QoL and levels of distress will be collected by an addendum to the patients’ questionnaire and a professionals’ questionnaire. The latter includes the Organizational Culture Assessment Instrument about the clinic’s culture as a possible determinant of an increase in patient-centered care. Discussion The study is expected to yield important new evidence about the effects of a multifaceted approach on levels of patient-centeredness, patients’ QoL and distress in fertility care. Furthermore, determinants associated with a change

  8. Behavioral counseling to prevent childhood obesity – study protocol of a pragmatic trial in maternity and child health care

    Directory of Open Access Journals (Sweden)

    Mustila Taina

    2012-07-01

    Full Text Available Abstract Background Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. Methods/Design A non-randomized controlled pragmatic trial in maternity and child health care clinics. The control group was recruited among families who visited the same clinics one year earlier. Eligibility criteria was mother at risk for gestational diabetes: body mass index ≥ 25 kg/m2, macrosomic newborn in any previous pregnancy, immediate family history of diabetes and/or age ≥ 40 years. All maternity clinics in town involved in recruitment. The gestational intervention consisted of individual counseling on diet and physical activity by a public health nurse, and of two group counseling sessions. Intervention continues until offspring’s age of five years. An option to participate a group counseling at child’s age 1 to 2 years was offered. The intervention includes advice on healthy diet, physical activity, sedentary behavior and sleeping pattern. The main outcome measure is offspring BMI z-score and its changes by the age of six years. Discussion Early childhood is a critical time period for prevention of obesity. Pragmatic trials targeting this period are necessary in order to find effective obesity prevention programs feasible in normal health care practice. Trial registration Clinical Trials gov NCT00970710

  9. Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Baumbach Sebastian Felix

    2013-01-01

    Full Text Available Abstract Background Ankle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains. Methods/Design 60 patients, aged 18–40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Samples will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-dependent weight bearing, limited functional immobilization by orthosis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, for 30 minutes for a period of 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform exercises similar to those of the control group, on a side-alternating sinusoidal vibration platform. Two time-dependent primary outcome parameters will be assessed: short-term outcome after six weeks will be postural control quantified by the sway index; mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include: return to pre-injury level of activities, residual pain, recurrence, objective instability, energy/coordination, Foot and Ankle Disability Index and EQ 5D. Discussion This is the first trial investigating the effects of WBV in patients with acute soft tissue injury. Inversion ankle sprains often result in ankle instability, which is most likely due to damage of neurological structures. Due to its unique, frequency dependent, influence on various

  10. The precision and robustness of published protocols for disc diffusion assays of antimicrobial agent susceptibility: an inter-laboratory study

    DEFF Research Database (Denmark)

    Gabhainn, S.N.; Bergh, Ø.; Dixon, B.;

    2004-01-01

    each agent being 11.1%. Significant influences on zone size were detected for all three parameters of the protocol. Media source effects were particularly notable with respect to oxytetracycline and oxolinic acid discs, disc source effects with respect to ampicillin and sulphamethoxazole...

  11. Interviews for the assessment of long-term incapacity for work : A study on adherence to protocols and principles

    NARCIS (Netherlands)

    Boer, W.E. de; Wind, H.; Dijk, F.J. van; Willems, H.H.

    2009-01-01

    Background. Assessments for long-term incapacity for work are performed by Social Insurance Physicians (SIPs) who rely on interviews with claimants as an important part of the process. These interviews are susceptible to bias. In the Netherlands three protocols have been developed to conduct these i

  12. Study protocol for examining job strain as a risk factor for severe unipolar depression in an individual participant meta-analysis of 14 European cohorts

    DEFF Research Database (Denmark)

    Madsen, Ida E H; Hannerz, Harald; Nyberg, Solja T;

    2013-01-01

    scales that do not necessarily correspond to clinically diagnosed depression. In addition, a meta-analysis from 2008 indicated publication bias in the field. METHODS: This study protocol describes the planned design and analyses of an individual participant data meta-analysis, to examine whether job......-reported working conditions data will be merged with national registers on psychiatric hospital treatment, primarily hospital admissions. Study-specific risk estimates for the association between job strain and depression will be calculated using Cox regressions. The study-specific risk estimates will be pooled...... using random effects meta-analysis. DISCUSSION: The planned analyses will help clarify whether job strain is associated with an increased risk of clinically diagnosed unipolar depression. As the analysis is based on pre-planned study protocols and an individual participant data meta-analysis, the pooled...

  13. Development of standardized bioassay protocols for the toxicity assessment of waste, manufactured products, and effluents in Latin America: Venezuela, a Case Study

    International Nuclear Information System (INIS)

    The present status of the toxicity assessment of industrial products in Latin America is well below North America/EC standards. As an example, most of Latin America regulatory laws regarding effluent discharge are still based upon concentration limits of certain major pollutants, and BOD/COD measurements; no reference is made to the necessity of aquatic bioassay toxicity data. Aware of this imperative need, the Venezuelan Petroleum Industry (PDVSA), through its R ampersand D Corporative branch (INTEVEP) gave priority to the development of standardized acute/sublethal toxicity test protocols as sound means of evaluating their products and wastes. Throughout this presentation, the Venezuelan case will be studied, showing strategies undertaken to accelerate protocol development. Results will show the assessment of 14 different protocols encompassing a variety of species of aquatic/terrestrial organisms, and a series of toxicity test endpoints including mortality, reproductive, biological and immunological measurements, most of which are currently in use or being developed. These protocols have already yielded useful results in numerous cases where toxicity assessment was required, including evaluations of effluent, oil dispersants, drilling fluids, toxic wastes, fossil fuels and newly developed products. The Venezuelan case demonstrates that the integration of Industry, Academia and Government, which is an essential part of SETAC's philosophy, is absolutely necessary for the successful advancement of environmental scientific/regulatory issues

  14. A cross-sectional study on person-centred communication in the care of older people: the COMHOME study protocol

    NARCIS (Netherlands)

    Hafskjold, L.; Sundler, A.J.; Holmstrom, I.K.; Sundling, V.; Dulmen, S. van; Eide, H.

    2015-01-01

    INTRODUCTION: This paper presents an international cross-sectional study on person-centred communication with older people receiving healthcare (COMHOME). Person-centred care relies on effective communication, but few studies have explored this with a specific focus on older people. The main aim of

  15. A cross-sectional study on person-centred communication in the care of older people: the COMHOME study protocol.

    NARCIS (Netherlands)

    Hafskjold, L.; Sundler, A.J.; Holmström, I.K.; Sundling, V.; Dulmen, S. van; Eide, H.

    2015-01-01

    Introduction: This paper presents an international cross-sectional study on person-centred communication with older people receiving healthcare (COMHOME). Person-centred care relies on effective communication, but few studies have explored this with a specific focus on older people. The main aim of

  16. Effects of Study Design and Allocation on participant behaviour - ESDA: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sheeran Paschal

    2011-02-01

    Full Text Available Abstract Background What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. Methods/Design A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participants who indicate a hazardous level of alcohol consumption will be randomly assigned to one of three groups. Group A will be informed their drinking will be assessed at baseline and again in one month (as in a cohort study design. Group B will be told the study is an intervention trial and they are in the control group. Group C will be told the study is an intervention trial and they are in the intervention group. All will receive exactly the same brief educational material to read. After one month, alcohol intake for the past 4 weeks will be assessed. Discussion The experimental manipulations address subtle and previously unexplored ways in which participant behaviour may be unwittingly influenced by standard practice in trials. Given the necessity of relying on self-reported outcome, it will not be possible to distinguish true behaviour change from reporting artefact. This does not matter in the present study, as any effects of awareness of study design or allocation involve bias that is not well understood. There has been little research on awareness effects, and our outcomes will provide an indication of the possible value of further studies of this type and inform hypothesis generation. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000846022

  17. Epigenetics protocols

    Directory of Open Access Journals (Sweden)

    Manuela Monti

    2012-06-01

    Full Text Available Thanks to the creative effort of Prof. Trygve O. Tollefsbol (Dept. of Biology, University of Alabama at Birmingham, USA we can handle the second edition in just seven years of this must needed volume devoted to the study of the epigenome. In the very same window-time the field of epigenetics is dramatically changed as for the technical tools employed by the pupils of this pervasive discipline: actually there is no one hot topics in biology (e.g., development, differentiation, genomic toxicity and medicine .....

  18. Monitoring activities of teenagers to comprehend their habits: study protocol for a mixed-methods cohort study

    OpenAIRE

    Bélanger, Mathieu; Caissie, Isabelle; Beauchamp, Jacinthe; O’Loughlin, Jennifer; Sabiston, Catherine; Mancuso, Michelina

    2013-01-01

    Background Efforts to increase physical activity in youth need to consider which activities are most likely to be sustained over time in order to promote lifelong participation in physical activity. The Monitoring Activities of Teenagers to Comprehend their Habits (MATCH) study is a prospective cohort study that uses quantitative and qualitative methods to develop new knowledge on the sustainability of specific physical activities. Methods/design Eight hundred and forty-three grade 5 and 6 st...

  19. The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial

    OpenAIRE

    Jimenez, Daniel E.; Reynolds, Charles F.; Alegría, Margarita; Harvey, Philip; Bartels, Stephen J.

    2015-01-01

    Background Results of previous studies attest to the greater illness burden of common mental disorders (anxiety and depression) in older Latinos and the need for developing preventive interventions that are effective, acceptable, and scalable. Happy Older Latinos are Active (HOLA) is a newly developed intervention that uses a community health worker (CHW) to lead a health promotion program in order to prevent common mental disorders among at-risk older Latinos. This pilot study tests the feas...

  20. The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial

    OpenAIRE

    Jimenez, Daniel E.; Reynolds, Charles F.; Alegría, Margarita; Harvey, Philip; Bartels, Stephen J.

    2015-01-01

    Background: Results of previous studies attest to the greater illness burden of common mental disorders (anxiety and depression) in older Latinos and the need for developing preventive interventions that are effective, acceptable, and scalable. Happy Older Latinos are Active (HOLA) is a newly developed intervention that uses a community health worker (CHW) to lead a health promotion program in order to prevent common mental disorders among at-risk older Latinos. This pilot study tests the fea...

  1. Evaluation of a large scale implementation of disease management programmes in various Dutch regions: a study protocol

    Directory of Open Access Journals (Sweden)

    Bal Roland A

    2011-01-01

    Full Text Available Abstract Background Disease management programmes (DMPs have been developed to improve effectiveness and economic efficiency within chronic care delivery by combining patient-related, professional-directed, and organisational interventions. The benefits of DMPs within different settings, patient groups, and versions remain unclear. In this article we propose a protocol to evaluate a range of current DMPs by capturing them in a single conceptual framework, employing comparable structure, process, and outcome measures, and combining qualitative and quantitative research methods. Methods To assess DMP effectiveness a practical clinical trial will be conducted. Twenty-two disease management experiments will be studied in various Dutch regions consisting of a variety of collaborations between organisations and/or professionals. Patient cohorts include those with cardiovascular diseases, chronic obstructive pulmonary disease, diabetes, stroke, depression, psychotic diseases, and eating disorders. Our methodological approach combines qualitative and quantitative research methods to enable a comprehensive evaluation of complex programmes. Process indicators will be collected from health care providers' data registries and measured via physician and staff questionnaires. Patient questionnaires include health care experiences, health care utilisation, and quality of life. Qualitative data will be gathered by means of interviews and document analysis for an in depth description of project interventions and the contexts in which DMPs are embedded, and an ethnographic process evaluation in five DMPs. Such a design will provide insight into ongoing DMPs and demonstrate which elements of the intervention are potentially (cost-effective for which patient populations. It will also enable sound comparison of the results of the different programmes. Discussion The study will lead to a better understanding of (1 the mechanisms of disease management, (2 the

  2. South Yorkshire Cohort: a 'cohort trials facility' study of health and weight - Protocol for the recruitment phase

    Directory of Open Access Journals (Sweden)

    Copeland Rob

    2011-08-01

    Full Text Available Abstract Background Growing levels of both obesity and chronic disease in the general population pose a major public health problem. In the UK, an innovative 'health and weight' cohort trials facility, the 'South Yorkshire Cohort', is being built in order to provide robust evidence to inform policy, commissioning and clinical decisions in this field. This protocol reports the design of the facility and outlines the recruitment phase methods. Method/Design The South Yorkshire Cohort health and weight study uses the cohort multiple randomised controlled trial design. This design recruits a large observational cohort of patients with the condition(s of interest which then provides a facility for multiple randomised controlled trials (with large representative samples of participants, long term outcomes as standard, increased comparability between each trial conducted within the cohort and increased efficiency particularly for trials of expensive interventions as well as ongoing information as to the natural history of the condition and treatment as usual. This study aims to recruit 20,000 participants to the population based South Yorkshire Cohort health and weight research trials facility. Participants are recruited by invitation letters from their General Practitioners. Data is collected using postal and/or online patient self completed Health Questionnaires. NHS numbers will be used to facilitate record linkage and access to routine data. Participants are eligible if they are: aged 16 - 85 years, registered with one of 40 practices in South Yorkshire, provide consent for further contact from the researchers and to have their information used to look at the benefit of health treatments. The first wave of data is being collected during 2010/12 and further waves are planned at 2 - 5 year intervals for the planned 20 year duration of the facility. Discussion The South Yorkshire Cohort combines the strengths of the standard observational

  3. Validating prediction scales of type 2 diabetes mellitus in Spain: the SPREDIA-2 population-based prospective cohort study protocol

    Science.gov (United States)

    Salinero-Fort, Miguel Ángel; de Burgos-Lunar, Carmen; Mostaza Prieto, José; Lahoz Rallo, Carlos; Abánades-Herranz, Juan Carlos; Gómez-Campelo, Paloma; Laguna Cuesta, Fernando; Estirado De Cabo, Eva; García Iglesias, Francisca; González Alegre, Teresa; Fernández Puntero, Belén; Montesano Sánchez, Luis; Vicent López, David; Cornejo Del Río, Víctor; Fernández García, Pedro J; Sabín Rodríguez, Concesa; López López, Silvia; Patrón Barandío, Pedro

    2015-01-01

    Introduction The incidence of type 2 diabetes mellitus (T2DM) is increasing worldwide. When diagnosed, many patients already have organ damage or advance subclinical atherosclerosis. An early diagnosis could allow the implementation of lifestyle changes and treatment options aimed at delaying the progression of the disease and to avoid cardiovascular complications. Different scores for identifying undiagnosed diabetes have been reported, however, their performance in populations of southern Europe has not been sufficiently evaluated. The main objectives of our study are: to evaluate the screening performance and cut-off points of the main scores that identify the risk of undiagnosed T2DM and prediabetes in a Spanish population, and to develop and validate our own predictive models of undiagnosed T2DM (screening model), and future T2DM (prediction risk model) after 5-year follow-up. As a secondary objective, we will evaluate the atherosclerotic burden of the population with undiagnosed T2DM. Methods and analysis Population-based prospective cohort study with baseline screening, to evaluate the performance of the FINDRISC, DANISH, DESIR, ARIC and QDScore, against the gold standard tests: Fasting plasma glucose, oral glucose tolerance and/or HbA1c. The sample size will include 1352 participants between the ages of 45 and 74 years. Analysis: sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio positive, likelihood ratio negative and receiver operating characteristic curves and area under curve. Binary logistic regression for the first 700 individuals (derivation) and last 652 (validation) will be performed. All analyses will be calculated with their 95% CI; statistical significance will be p<0.05. Ethics and dissemination The study protocol has been approved by the Research Ethics Committee of the Carlos III Hospital (Madrid). The score performance and predictive model will be presented in medical conferences, workshops

  4. Born in Bradford, a cohort study of babies born in Bradford, and their parents: Protocol for the recruitment phase

    Directory of Open Access Journals (Sweden)

    Raynor Pauline

    2008-09-01

    Full Text Available Abstract Background Bradford, one of the most deprived cities in the United Kingdom, has a wide range of public health problems associated with socioeconomic deprivation, including an infant mortality rate almost double that for England and Wales. Infant mortality is highest for babies of Pakistani origin, who comprise almost half the babies born in Bradford. The Born in Bradford cohort study aims to examine environmental, psychological and genetic factors that impact on health and development perinatally, during childhood and subsequent adult life, and those that influence their parents' health and wellbeing. This protocol outlines methods for the recruitment phase of the study. Methods Most Bradford women attend for antenatal care and give birth at the Bradford Royal Infirmary, which has approximately 5,800 births per year. Women are eligible for recruitment if they plan to give birth here. Babies born from March 2007 are eligible to participate, recruitment is planned to continue until 2010. Fathers of babies recruited are invited to participate. Women are usually recruited when they attend for a routine oral glucose tolerance test at 26–28 weeks gestation. Recruitment of babies is at birth. Fathers are recruited whenever possible during the antenatal period, or soon after the birth. The aim is to recruit 10,000 women, their babies, and the babies' fathers. At recruitment women have blood samples taken, are interviewed to complete a semi-structured questionnaire, weighed, and have height, arm circumference and triceps skinfold measured. Umbilical cord blood is collected at birth. Within two weeks of birth babies have their head, arm and abdominal circumference measured, along with subscapular and triceps skinfold thickness. Fathers self-complete a questionnaire at recruitment, have height and weight measured, and provide a saliva sample. Participants are allocated a unique study number. NHS numbers will be used to facilitate record linkage

  5. Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS Trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dörr Jan

    2012-02-01

    Full Text Available Abstract Background Multiple sclerosis is the most common chronic inflammatory disease of the central nervous system in young adults. Despite the fact that numerous lines of evidence link both the risk of disease development and the disease course to the serum level of 25-hydroxyvitamin D it still remains elusive whether multiple sclerosis patients benefit from boosting the serum level of 25-hydroxyvitamin D, mainly because interventional clinical trials that directly address the therapeutic effects of vitamin D in multiple sclerosis are sparse. We here present the protocol of an interventional clinical phase II study to test the hypothesis, that high-dose vitamin D supplementation of multiple sclerosis patients is safe and superior to low-dose supplementation with respect to beneficial therapeutic effects. Methods/Design The EVIDIMS trial is a German multi-center, stratified, randomized, controlled and double-blind clinical phase II pilot study. Eighty patients with the diagnosis of definite multiple sclerosis or clinically isolated syndrome who are on a stable immunomodulatory treatment with interferon-β1b will be randomized to additionally receive either high-dose (average daily dose 10.200 IU or low-dose (average daily dose 200 IU cholecalciferol for a total period of 18 months. The primary outcome measure is the number of new lesions detected on T2-weighted cranial MRI at 3 tesla. Secondary endpoints include additional magnetic resonance imaging and optical coherence tomography parameters for neuroinflammation and -degeneration, clinical parameters for disease activity, as well as cognition, fatigue, depression, and quality of life. Safety and tolerability of high-dose vitamin D supplementation are further outcome parameters. Discussion In light of the discrepancy between existing epidemiological and preclinical data on the one hand and available clinical data on the other the EVIDIMS trial will substantially contribute to the evaluation

  6. Dysphonia risk screening protocol

    Directory of Open Access Journals (Sweden)

    Katia Nemr

    2016-03-01

    Full Text Available OBJECTIVE: To propose and test the applicability of a dysphonia risk screening protocol with score calculation in individuals with and without dysphonia. METHOD: This descriptive cross-sectional study included 365 individuals (41 children, 142 adult women, 91 adult men and 91 seniors divided into a dysphonic group and a non-dysphonic group. The protocol consisted of 18 questions and a score was calculated using a 10-cm visual analog scale. The measured value on the visual analog scale was added to the overall score, along with other partial scores. Speech samples allowed for analysis/assessment of the overall degree of vocal deviation and initial definition of the respective groups and after six months, the separation of the groups was confirmed using an acoustic analysis. RESULTS: The mean total scores were different between the groups in all samples. Values ranged between 37.0 and 57.85 in the dysphonic group and between 12.95 and 19.28 in the non-dysphonic group, with overall means of 46.09 and 15.55, respectively. High sensitivity and specificity were demonstrated when discriminating between the groups with the following cut-off points: 22.50 (children, 29.25 (adult women, 22.75 (adult men, and 27.10 (seniors. CONCLUSION: The protocol demonstrated high sensitivity and specificity in differentiating groups of individuals with and without dysphonia in different sample groups and is thus an effective instrument for use in voice clinics.

  7. Protocol for a systematic review on the extent of non-publication of research studies and associated study characteristics

    Directory of Open Access Journals (Sweden)

    Portalupi Susan

    2013-01-01

    Full Text Available Abstract Background Methodological research has found that non-published studies often have different results than those that are published, a phenomenon known as publication bias. When results are not published, or are published selectively based on the direction or the strength of the findings, healthcare professionals and consumers of healthcare cannot base their decision-making on the full body of current evidence. Methods As part of the OPEN project (http://www.open-project.eu we will conduct a systematic review with the following objectives: 1. To determine the proportion and/or rate of non-publication of studies by systematically reviewing methodological research projects that followed up a cohort of studies that a. received research ethics committee (REC approval, b. were registered in trial registries, or c. were presented as abstracts at conferences. 2. To assess the association of study characteristics (for example, direction and/or strength of findings with likelihood of full publication. To identify reports of relevant methodological research projects we will conduct electronic database searches, check reference lists, and contact experts. Published and unpublished projects will be included. The inclusion criteria are as follows: a. RECs: methodological research projects that examined the subsequent proportion and/or rate of publication of studies that received approval from RECs; b. Trial registries: methodological research projects that examine the subsequent proportion and/or rate of publication of studies registered in trial registries; c. Conference abstracts: methodological research projects that examine the subsequent proportion and/or rate of full publication of studies which were initially presented at conferences as abstracts. Primary outcomes: Proportion/rate of published studies; time to full publication (mean/median; cumulative publication rate by time. Secondary outcomes: Association of study characteristics with full

  8. 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

    2016-01-01

    Introduction 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. Design and methods 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. Ethics and dissemination 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

  9. The German MultiCare-study: Patterns of multimorbidity in primary health care – protocol of a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Schäfer Ingmar

    2009-08-01

    Full Text Available Abstract Background Multimorbidity is a highly frequent condition in older people, but well designed longitudinal studies on the impact of multimorbidity on patients and the health care system have been remarkably scarce in numbers until today. Little is known about the long term impact of multimorbidity on the patients' life expectancy, functional status and quality of life as well as health care utilization over time. As a consequence, there is little help for GPs in adjusting care for these patients, even though studies suggest that adhering to present clinical practice guidelines in the care of patients with multimorbidity may have adverse effects. Methods/Design The study is designed as a multicentre prospective, observational cohort study of 3.050 patients aged 65 to 85 at baseline with at least three different diagnoses out of a list of 29 illnesses and syndromes. The patients will be recruited in approx. 120 to 150 GP surgeries in 8 study centres distributed across Germany. Information about the patients' morbidity will be collected mainly in GP interviews and from chart reviews. Functional status, resources/risk factors, health care utilization and additional morbidity data will be assessed in patient interviews, in which a multitude of well established standardized questionnaires and tests will be performed. Discussion The main aim of the cohort study is to monitor the course of the illness process and to analyse for which reasons medical conditions are stable, deteriorating or only temporarily present. First, clusters of combinations of diseases/disorders (multimorbidity patterns with a comparable impact (e.g. on quality of life and/or functional status will be identified. Then the development of these clusters over time will be analysed, especially with regard to prognostic variables and the somatic, psychological and social consequences as well as the utilization of health care resources. The results will allow the development of an

  10. Comparative study between uses of GnRH- agonist versus hCG as an ovulation trigger in patients with polycystic ovary syndrome in antagonist protocol

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    Poornima Nadkarni

    2015-08-01

    Full Text Available Background: Polycystic ovary syndrome is one of the major causes of infertility. Almost 75% of ovulatory women have PCOS. Ovarian hyperstimulation syndrome and multiple pregnancies are known complications of PCOS in ART. Many studies are available now, to reduce the incidence and severity of OHSS in these patients, at the same time achieving acceptable pregnancy rate .In our study, we used Antagonist protocol in PCOS patients and compared the results using GnRH-Agonist versus hCG as ovulation trigger. Methods: This is double blinded comparative study between uses of GnRH- Agonist versus hCG as an ovulation trigger in 100 patients with polycystic ovary syndrome in antagonist protocol, done in private ART setting. In the study, 100 patients randomly allotted in two groups (A and B, each 50 patients, given ovulation trigger (When leading three follicles were >18 mm as group A-GnRH-Agonist (Inj. Triptoreline 0.1 mg, 12 hours apart two doses subcutaneously and group B hCG as (Inj. Recombinant hCG, 250 mcg single dose subcutaneously. Results: In our study, In 50 patients of group A, total 31 patients were pregnant. In group B of 50 cases, 29 patients were pregnant. There was no significant difference between two groups (P>0.05. Incidence of ovarian hyperstimulation syndrome is significantly less in PCOS patients, when GnRH agonist is used as ovulation trigger in Antagonist protocol, as compared to hCG (P 0.05. None patient of two groups developed severe OHSS. Conclusions: Incidence of the ovarian hyperstimulation syndrome is significantly less in patients with Polycystic Ovarian Syndrome when GnRH agonist is used as an ovulation trigger, as compared to hCG, in Antagonist protocol. In our study, there was no significant difference in pregnancy rates between two groups. [Int J Reprod Contracept Obstet Gynecol 2015; 4(4.000: 1161-1164

  11. Innovative approach for increasing physical activity among breast cancer survivors: protocol for Project MOVE, a quasi-experimental study

    Science.gov (United States)

    Caperchione, Cristina M; Sabiston, Catherine M; Clark, Marianne I; Bottorff, Joan L; Toxopeus, Renee; Campbell, Kristin L; Eves, Neil D; Ellard, Susan L; Gotay, Carolyn

    2016-01-01

    Introduction Physical activity is a cost-effective and non-pharmaceutical strategy that can help mitigate the physical and psychological health challenges associated with breast cancer survivorship. However, up to 70% of women breast cancer survivors are not meeting minimum recommended physical activity guidelines. Project MOVE is an innovative approach to increase physical activity among breast cancer survivors through the use of Action Grants, a combination of microgrants (small amounts of money awarded to groups of individuals to support a physical activity initiative) and financial incentives. The purpose of this paper is to describe the rationale and protocol of Project MOVE. Method and analysis A quasi-experimental pre–post design will be used. Twelve groups of 8–12 adult women who are breast cancer survivors (N=132) were recruited for the study via face-to-face meetings with breast cancer-related stakeholders, local print and radio media, social media, and pamphlets and posters at community organisations and medical clinics. Each group submitted a microgrant application outlining their proposed physical activity initiative. Successful applicants were determined by a grant review panel and informed of a financial incentive on meeting their physical activity goals. An evaluation of feasibility will be guided by the reach, effectiveness, adoption, implementation, maintenance (RE-AIM) framework and assessed through focus groups, interviews and project-related reports. Physical activity will be assessed through accelerometry and by self-report. Quality of life, motivation to exercise and social connection will also be assessed through self-report. Assessments will occur at baseline, 6 months and 1 year. Ethics and dissemination Ethical approval was obtained from the University of British Columbia's Behavioural Research Ethics Board (#H14-02502) and has been funded by the Canadian Cancer Society Research Institute (project number #702913). Study findings

  12. Monitoring the impact of the DRG payment system on nursing service context factors in Swiss acute care hospitals: Study protocol

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    Spirig, Rebecca

    2014-03-01

    Full Text Available [english] Aims: With this study protocol, a research program is introduced. Its overall aim is to prepare the instruments and to conduct the first monitoring of nursing service context factors at three university and two cantonal hospitals in Switzerland prior to the introduction of the reimbursement system based on Diagnosis Related Groups (DRG and to further develop a theoretical model as well as a methodology for future monitoring following the introduction of DRGs.Background: DRG was introduced to all acute care hospitals in Switzerland in 2012. In other countries, DRG introduction led to rationing and subsequently to a reduction in nursing care. As result, nursing-sensitive patient outcomes were seriously jeopardised. Switzerland has the opportunity to learn from the consequences experienced by other countries when they introduced DRGs. Their experiences highlight that DRGs influence nursing service context factors such as complexity of nursing care or leadership, which in turn influence nursing-sensitive patient outcomes. For this reason, the monitoring of nursing service context factors needs to be an integral part of the introduction of DRGs. However, most acute care hospitals in Switzerland do not monitor nursing service context data. Nursing managers and hospital executive boards will be in need of this data in the future, in order to distribute resources effectively. Methods/Design: A mixed methods design in the form of a sequential explanatory strategy was chosen. During the preparation phase, starting in spring 2011, instruments were selected and prepared, and the access to patient and nursing data in the hospitals was organized. Following this, online collection of quantitative data was conducted in fall 2011. In summer 2012, qualitative data was gathered using focus group interviews, which helped to describe the processes in more detail. During 2013 and 2014, an integration process is being conducted involving complementing

  13. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial

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    Peters Amy L

    2007-05-01

    Full Text Available Abstract Background Previous research investigating exercise as a means of falls prevention in older adults has shown mixed results. Lack of specificity of the intervention may be an important factor contributing to negative results. Change-in-support (CIS balance reactions, which involve very rapid stepping or grasping movements of the limbs, play a critical role in preventing falls; hence, a training program that improves ability to execute effective CIS reactions could potentially have a profound effect in reducing risk of falling. This paper describes: 1 the development of a perturbation-based balance training program that targets specific previously-reported age-related impairments in CIS reactions, and 2 a study protocol to evaluate the efficacy of this new training program. Methods/Design The training program involves use of unpredictable, multi-directional moving-platform perturbations to evoke stepping and grasping reactions. Perturbation magnitude is gradually increased over the course of the 6-week program, and concurrent cognitive and movement tasks are included during later sessions. The program was developed in accordance with well-established principles of motor learning, such as individualisation, specificity, overload, adaptation-progression and variability. Specific goals are to reduce the frequency of multiple-step responses, reduce the frequency of collisions between the stepping foot and stance leg, and increase the speed of grasping reactions. A randomised control trial will be performed to evaluate the efficacy of the training program. A total of 30 community-dwelling older adults (age 64–80 with a recent history of instability or falling will be assigned to either the perturbation-based training or a control group (flexibility/relaxation training, using a stratified randomisation that controls for gender, age and baseline stepping/grasping performance. CIS reactions will be tested immediately before and after the six

  14. Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1: study protocol for a randomized controlled trial

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    McCambridge Jim

    2012-07-01

    Full Text Available Abstract Background Alcohol causes huge problems for population health and for society, which require interventions with individuals as well as populations to prevent and reduce harms. Brief interventions can be effective and increasingly take advantage of the internet to reach high-risk groups such as students. The research literature on the effectiveness of online interventions is developing rapidly and is confronted by methodological challenges common to other areas of e-health including attrition and assessment reactivity and in the design of control conditions. Methods/design The study aim is to evaluate the effectiveness of a brief online intervention, employing a randomized controlled trial (RCT design that takes account of baseline assessment reactivity, and other possible effects of the research process. Outcomes will be evaluated after 3 months both among student populations as a whole including for a randomized no contact control group and among those who are risky drinkers randomized to brief assessment and feedback (routine practice or to brief assessment only. A three-arm parallel groups trial will also allow exploration of the magnitude of the feedback and assessment component effects. The trial will be undertaken simultaneously in 2 universities randomizing approximately 15,300 students who will all be blinded to trial participation. All participants will be offered routine practice intervention at the end of the study. Discussion This trial informs the development of routine service delivery in Swedish universities and more broadly contributes a new approach to the study of the effectiveness of online interventions in student populations, with relevance to behaviors other than alcohol consumption. The use of blinding and deception in this study raise ethical issues that warrant further attention. Trial registration ISRCTN28328154

  15. Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial

    OpenAIRE

    Sofi, Francesco; Dinu, Monica; Pagliai, Giuditta; Cesari, Francesca; Marcucci, Rossella; Casini, Alessandro

    2016-01-01

    Background Nutrition is able to alter the cardiovascular health of the general population. However, the optimal dietary strategy for cardiovascular disease prevention is still far from being defined. Mediterranean and vegetarian diets are those reporting the greatest grade of evidence in the literature, but no experimental studies comparing these two dietary patterns are available. Methods/design This is an open randomized crossover clinical trial including healthy subjects with a low-to-medi...

  16. Efficacy of vision restoration therapy after optic neuritis (VISION study: study protocol for a randomized controlled trial

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    Schinzel Johann

    2012-06-01

    Full Text Available Abstract Background Optic neuritis is a frequent manifestation of multiple sclerosis. Visual deficits range from a minor impairment of visual functions through to complete loss of vision. Although many patients recover almost completely, roughly 35% of patients remain visually impaired for years, and therapeutic options for those patients hardly exist. Vision restoration therapy is a software-based visual training program that has been shown to improve visual deficits after pre- and postchiasmatic injury. The aim of this pilot study is to evaluate whether residual visual deficits after past or recent optic neuritis can be reduced by means of vision restoration therapy. Methods/design A randomized, controlled, patient- and observer-blinded clinical pilot study (VISION study was designed to evaluate the efficacy of vision restoration therapy in optic neuritis patients. Eighty patients with a residual visual deficit after optic neuritis (visual acuity ≤0.7 and/or scotoma will be stratified according to the time of optic neuritis onset (manifestation more than 12 months ago (40 patients, fixed deficit versus manifestation 2 to 6 months ago (40 patients, recent optic neuritis, and randomized into vision restoration therapy arm or saccadic training arm (control intervention. Patients will be instructed to complete a computer-based visual training for approximately 30 minutes each day for a period of 6 months. Patients and evaluators remain blinded to the treatment allocation throughout the study. All endpoints will be analyzed and P-values  Discussion If vision restoration therapy is shown to improve visual function after optic neuritis, this method might be a first therapeutic option for patients with incomplete recovery from optic neuritis. Trial registration NCT01274702

  17. Hypnosis for hot flashes among postmenopausal women study: A study protocol of an ongoing randomized clinical trial

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    Johnson Aimee K

    2011-10-01

    Full Text Available Abstract Background Hot flashes are a highly prevalent problem associated with menopause and breast cancer treatments. The recent findings from the Women's Health Initiative have important implications for the significance of a non-hormonal, mind-body intervention for hot flashes in breast cancer survivors. Women who take hormone therapy long-term may have a 1.2 to 2.0 fold increased risk of developing breast cancer. In addition, it is now known that hormone therapy with estrogen and progestin is associated with increased risk of cardiovascular disease and stroke. Currently there are limited options to hormone replacement therapy as non-hormonal pharmacological agents are associated with only modest activity and many adverse side effects. Because of this there is a need for more alternative, non-hormonal therapies. Hypnosis is a mind-body intervention that has been shown to reduce self-reported hot flashes by up to 68% among breast cancer survivors, however, the use of hypnosis for hot flashes among post-menopausal women has not been adequately explored and the efficacy of hypnosis in reducing physiologically measured hot flashes has not yet been determined. Methods/design A sample of 180 post-menopausal women will be randomly assigned to either a 5-session Hypnosis Intervention or 5-session structured-attention control with 12 week follow-up. The present study will compare hypnosis to a structured-attention control in reducing hot flashes (perceived and physiologically monitored in post-menopausal women in a randomized clinical trial. Outcomes will be hot flashes (self-report daily diaries; physiological monitoring; Hot Flash Related Daily Interference Scale, anxiety (State-Trait Anxiety Inventory; Hospital Anxiety and Depression Scale (HADS; anxiety visual analog scale (VAS rating; depression (Center for Epidemiologic Studies Depression Scale, sexual functioning (Sexual Activity Questionnaire, sleep quality (Pittsburgh Sleep Quality Index and

  18. Psychological, social and biological determinants of ill health (pSoBid: Study Protocol of a population-based study

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    McGinty Agnes

    2008-04-01

    Full Text Available Abstract Background Disadvantaged communities suffer higher levels of physical and mental ill health than more advantaged communities. The purpose of the present study was to examine the psychosocial, behavioural and biological determinants of ill health within population groups in Glasgow that differed in socioeconomic status and in their propensity to develop chronic disease especially coronary heart disease and Type 2 diabetes mellitus. Methods Participants were selected at random from areas known to be at the extremes of the socioeconomic continuum in Glasgow. Within the categories of least deprived and most deprived, recruitment was stratified by sex and age to achieve an overall sample containing approximately equal numbers of males and females and an even distribution across the age categories 35–44, 45–54 and 55–64 years. Individuals were invited by letter to attend for assessment of their medical history, risk factor status, cognitive function and psychological profile, morbidity, and carotid intima-media thickness and plaque count as indices of atherosclerosis. Anonymised data on study subjects were collected from the General Practice Administration System for Scotland to analyse characteristics of participants and non-participants. Results 700 subjects were recruited. The response (active participants per 100 invitation letters in the least deprived group was 35.1% and in the most deprived group was 20.3%. Lowest response was seen in young males (least deprived 22.4% and most deprived 14.1%. Conclusion This cross-sectional study recruited the planned sample of subjects from least deprived and most deprived areas within Glasgow. As evident in other studies response differed between the most and least deprived areas. This study brought together researchers/academics from diverse disciplines to build a more sophisticated understanding of the determinants of health inequalities than can be achieved through unidisciplinary approaches

  19. Follow-up study of the regional quota system of Japanese medical schools and prefecture scholarship programmes: a study protocol

    Science.gov (United States)

    Matsumoto, Masatoshi; Takeuchi, Keisuke; Tanaka, Junko; Tazuma, Susumu; Inoue, Kazuo; Owaki, Tetsuhiro; Iguchi, Seitaro; Maeda, Takahiro

    2016-01-01

    Introduction Given the shortage of physicians, particularly in rural areas, the Japanese government has rapidly expanded the number of medical school students by adding chiikiwaku (regional quotas) since 2008. Quota entrants now account for 17% of all medical school entrants. Quota entrants are usually local high school graduates who receive a scholarship from the prefecture government. In exchange, they temporarily practise in that prefecture, including its rural areas, after graduation. Many prefectures also have scholarship programmes for non-quota students in exchange for postgraduate in-prefecture practice. The objective of this cohort study, conducted by the Japanese Council for Community-based Medical Education, is to evaluate the outcomes of the quota admission system and prefecture scholarship programmes nationwide. Methods and analysis There are 3 groups of study participants: quota without scholarship, quota with scholarship and non-quota with scholarship. Under the support of government ministries and the Association of Japan Medical Colleges, and participation of all prefectures and medical schools, passing rate of the National Physician License Examination, scholarship buy-out rate, geographic distribution and specialties distribution of each group are analysed. Participants who voluntarily participated are followed by linking their baseline information to data in the government's biennial Physician Census. Results to date have shown that, despite medical schools' concerns about academic quality, the passing rate of the National Physician License Examination in each group was higher than that of all medical school graduates. Ethics and dissemination The Ethics Committee for Epidemiological Research of Hiroshima University and the Research Ethics Committee of Nagasaki University Graduate School of Biomedical Sciences permitted this study. No individually identifiable results will be presented in conferences or published in journals. The aggregated

  20. Autonomy among physically frail older people in nursing home settings: a study protocol for an intervention study

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    Andresen Mette

    2008-12-01

    Full Text Available Abstract Background Experiencing autonomy is recognised to promote health and well-being for all age groups. Perceived lack of control has been found to be detrimental to physical and mental health. There is a lack of evidence-based knowledge elucidating how frail older people in nursing home settings themselves perceive autonomy in daily life. Further, there are no studies on the extent to which this perception can be influenced positively by participating in an individually tailored programme based on residents' own wishes for daily activities. Methods and design A total of 9 nursing homes and 55 participants aged 65 years or older were included in the study. All the participants were restricted in performing at least one P-ADL activity unassisted and had a Mini Mental State Examination-score above 16. Perceived autonomy was measured at baseline, after 12 weeks and after 24 weeks by The Autonomy Sub-dimension in the Measure of Actualisation of Potential test. Programmes were based on participants' individual assessment of their most important daily activities. Staff at all nursing homes who usually organize physical training, social or creative activities carried out individually tailored programmes using their usual methods and equipment. Participants in each nursing home were divided by lot into either a control group or an intervention group. The control groups received their usual care and treatment. Discussion This study is designed to assess the status of perceived autonomy at baseline and to provide information about the effectiveness of individually tailored programmes according to perceptions of autonomy registered in institutionalised physically frail older people. This will add knowledge to assist response to present and future challenges in relation to health promotion initiatives for this group. Trial registration number NCT00783055

  1. Strengthening organizational performance through accreditation research-a framework for twelve interrelated studies: the ACCREDIT project study protocol

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    Pope Catherine

    2011-10-01

    Full Text Available Abstract Background Service accreditation is a structured process of recognising and promoting performance and adherence to standards. Typically, accreditation agencies either receive standards from an authorized body or develop new and upgrade existing standards through research and expert views. They then apply standards, criteria and performance indicators, testing their effects, and monitoring compliance with them. The accreditation process has been widely adopted. The international investments in accreditation are considerable. However, reliable evidence of its efficiency or effectiveness in achieving organizational improvements is sparse and the value of accreditation in cost-benefit terms has yet to be demonstrated. Although some evidence suggests that accreditation promotes the improvement and standardization of care, there have been calls to strengthen its research base. In response, the ACCREDIT (Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork project has been established to evaluate the effectiveness of Australian accreditation in achieving its goals. ACCREDIT is a partnership of key researchers, policymakers and agencies. Findings We present the framework for our studies in accreditation. Four specific aims of the ACCREDIT project, which will direct our findings, are to: (i evaluate current accreditation processes; (ii analyse the costs and benefits of accreditation; (iii improve future accreditation via evidence; and (iv develop and apply new standards of consumer involvement in accreditation. These will be addressed through 12 interrelated studies designed to examine specific issues identified as a high priority. Novel techniques, a mix of qualitative and quantitative methods, and randomized designs relevant for health-care research have been developed. These methods allow us to circumvent the fragmented and incommensurate findings that can be generated in small

  2. Study protocol for a randomized controlled trial: tongue strengthening exercises in head and neck cancer patients, does exercise load matter?

    OpenAIRE

    Van Nuffelen, Gwen; Van den Steen, Leen; Vanderveken, Olivier; Specenier, Pol; Van Laer, Carl; Van Rompaey, Diane; Guns, Cindy; Mariën, Steven; Peeters, Marc; van de Heyning, Paul; Vanderwegen, Jan; De Bodt, Marc

    2015-01-01

    Background Reduced tongue strength is an important factor contributing to early and late dysphagia in head and neck cancer patients previously treated with chemoradiotherapy. The evidence is growing that tongue strengthening exercises can improve tongue strength and swallowing function in both healthy and dysphagic subjects. However, little is known about the impact of specific features of an exercise protocol for tongue strength on the actual outcome (strength or swallowing function). Previo...

  3. Population-centered Risk- and Evidence-based Dental Interprofessional Care Team (PREDICT): study protocol for a randomized controlled trial

    OpenAIRE

    Cunha-Cruz, Joana; Milgrom, Peter; Shirtcliff, R. Michael; Bailit, Howard L.; Huebner, Colleen E; Conrad, Douglas; Ludwig, Sharity; Mitchell, Melissa; Dysert, Jeanne; Allen, Gary; Scott, JoAnna; Mancl, Lloyd

    2015-01-01

    Background To improve the oral health of low-income children, innovations in dental delivery systems are needed, including community-based care, the use of expanded duty auxiliary dental personnel, capitation payments, and global budgets. This paper describes the protocol for PREDICT (Population-centered Risk- and Evidence-based Dental Interprofessional Care Team), an evaluation project to test the effectiveness of new delivery and payment systems for improving dental care and oral health. Me...

  4. Self-Help And Recovery guide for Eating Disorders (SHARED): study protocol for a randomized controlled trial

    OpenAIRE

    Cardi, Valentina; Ambwani, Suman; Crosby, Ross; Macdonald, Pamela; Todd, Gill; Park, Jinhong; Moss, Sara; Schmidt, Ulrike; Treasure, Janet

    2015-01-01

    Background: We describe the theoretical rationale and protocol for Self-Help And Recovery guide for Eating Disorders (SHARED), a trial investigating whether a guided self-care intervention (Recovery MANTRA) is a useful addition to treatment as usual for individuals with anorexia nervosa. Recovery MANTRA, a 6-week self-care intervention supplemented by peer mentorship, is a module extension of the Maudsley Model of Treatment for Adults with Anorexia Nervosa and targets the maintenance factors ...

  5. Better movers and thinkers (BMT): A quasi-experimental study into the impact of physical education on children's cognition-A study protocol.

    Science.gov (United States)

    Dalziell, Andrew; Boyle, James; Mutrie, Nanette

    2015-01-01

    This study will extend on a pilot study and will evaluate the impact of a novel approach to PE, Better Movers and Thinkers (BMT), on students' cognition, physical activity habits, and gross motor coordination (GMC). The study will involve six mainstream state schools with students aged 9-11 years. Three schools will be allocated as the intervention condition and three as the control condition. The design of the study is a 16-week intervention with pre-, post- and 6 month follow-up measurements taken using the 'Cognitive Assessment System (CAS)' GMC tests, and the 'Physical Activity Habits Questionnaire for Children (PAQ-C).' Qualitative data will be gathered using student focus groups and class teacher interviews in each of the six schools. ANCOVA will be used to evaluate any effect of intervention comparing pre-test scores with post-test scores and then pre-test scores with 6 month follow-up scores. Qualitative data will be analysed through an iterative process using grounded theory. This protocol provides the details of the rationale and design of the study and details of the intervention, outcome measures, and the recruitment process. The study will address gaps within current research by evaluating if a change of approach in the delivery of PE within schools has an effect on children's cognition, PA habits, and GMC within a Scottish setting. PMID:26844172

  6. Better movers and thinkers (BMT): A quasi-experimental study into the impact of physical education on children's cognition—A study protocol

    Science.gov (United States)

    Dalziell, Andrew; Boyle, James; Mutrie, Nanette

    2015-01-01

    This study will extend on a pilot study and will evaluate the impact of a novel approach to PE, Better Movers and Thinkers (BMT), on students' cognition, physical activity habits, and gross motor coordination (GMC). The study will involve six mainstream state schools with students aged 9–11 years. Three schools will be allocated as the intervention condition and three as the control condition. The design of the study is a 16-week intervention with pre-, post- and 6 month follow-up measurements taken using the ‘Cognitive Assessment System (CAS)’ GMC tests, and the ‘Physical Activity Habits Questionnaire for Children (PAQ-C).’ Qualitative data will be gathered using student focus groups and class teacher interviews in each of the six schools. ANCOVA will be used to evaluate any effect of intervention comparing pre-test scores with post-test scores and then pre-test scores with 6 month follow-up scores. Qualitative data will be analysed through an iterative process using grounded theory. This protocol provides the details of the rationale and design of the study and details of the intervention, outcome measures, and the recruitment process. The study will address gaps within current research by evaluating if a change of approach in the delivery of PE within schools has an effect on children's cognition, PA habits, and GMC within a Scottish setting. PMID:26844172

  7. Transarterial RAdioembolization versus ChemoEmbolization for the treatment of hepatocellular carcinoma (TRACE: study protocol for a randomized controlled trial

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    Seinstra Beatrijs A

    2012-08-01

    Full Text Available Abstract Background Hepatocellular carcinoma is a primary malignant tumor of the liver that accounts for an important health problem worldwide. Only 10 to 15% of hepatocellular carcinoma patients are suitable candidates for treatment with curative intent, such as hepatic resection and liver transplantation. A majority of patients have locally advanced, liver restricted disease (Barcelona Clinic Liver Cancer (BCLC staging system intermediate stage. Transarterial loco regional treatment modalities offer palliative treatment options for these patients; transarterial chemoembolization (TACE is the current standard treatment. During TACE, a catheter is advanced into the branches of the hepatic artery supplying the tumor, and a combination of embolic material and chemotherapeutics is delivered through the catheter directly into the tumor. Yttrium-90 radioembolization (90Y-RE involves the transarterial administration of minimally embolic microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor. 90Y-RE is increasingly used in clinical practice for treatment of intermediate stage hepatocellular carcinoma, but its efficacy has never been prospectively compared to that of the standard treatment (TACE. In this study, we describe the protocol of a multicenter randomized controlled trial aimed at comparing the effectiveness of TACE and 90Y-RE for treatment of patients with unresectable (BCLC intermediate stage hepatocellular carcinoma. Methods/design In this pragmatic randomized controlled trial, 140 patients with unresectable (BCLC intermediate stage hepatocellular carcinoma, with Eastern Cooperative Oncology Group performance status 0 to 1 and Child-Pugh A to B will be randomly assigned to either 90Y-RE or TACE with drug eluting beads. Patients assigned to 90Y-RE will first receive a diagnostic angiography, followed by the actual transarterial treatment, which can be divided into two sessions in case

  8. Potential Heating Effect in the Gravid Uterus by Using 3-T MR Imaging Protocols: Experimental Study in Miniature Pigs.

    Science.gov (United States)

    Cannie, Mieke M; De Keyzer, Frederik; Van Laere, Sigrid; Leus, Astrid; de Mey, Johan; Fourneau, Catherine; De Ridder, Filip; Van Cauteren, Toon; Willekens, Inneke; Jani, Jacques C

    2016-06-01

    Purpose To determine the changes in temperature within the gravid miniature pig uterus during magnetic resonance (MR) imaging at 3 T. Materials and Methods The study received ethics committee approval for animal experimentation. Fiber-optic temperature sensors were inserted into the fetal brain, abdomen, bladder, and amniotic fluid of miniature pigs (second trimester, n = 2; third trimester, n = 2). In the first trimester (n = 2), the sensors were inserted only into the amniotic fluid (three sacs per miniature pig, for a total of six sacs). Imaging was performed with a 3-T MR imager by using different imaging protocols in a random order for animal, each lasting approximately 15 minutes. The first regimen consisted of common sequences used for human fetal MR examination, including normal specific absorption rate (SAR). The second regimen consisted of five low-SAR sequences, for which three gradient-echo sequences were interspersed with two diffusion-weighted imaging series. Finally, a high-SAR regimen maximized the radiofrequency energy deposition (constrained by the 2-W per kilogram of body weight SAR limitations) by using five single-shot turbo spin-echo sequences. Differences in temperature increases between the three regimens and between the three trimesters were evaluated by using one-way analysis of variance. The maximum cumulative temperature increase over 1 hour was also evaluated. Results Low-SAR regimens resulted in the lowest temperature increase (mean ± standard deviation, -0.03°C ± 0.20), normal regimens resulted in an intermediate increase (0.31°C ± 0.21), and high-SAR regimens resulted in the highest increase (0.56°C ± 0.20) (P pregnant miniature pigs, the use of 3-T magnets for diagnostic MR imaging with normal SAR regimens does not lead to temperature increases above 1°C if imaging time is kept below 30 minutes. Longer imaging time, especially with high-SAR regimens, can lead to an increase of 2.5°C. (©) RSNA, 2015 Online supplemental

  9. Effectiveness of trigger point dry needling for plantar heel pain: study protocol for a randomised controlled trial

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    Landorf Karl B

    2011-01-01

    Full Text Available Abstract Background Plantar heel pain (plantar fasciitis is a common and disabling condition, which has a detrimental impact on health-related quality of life. Despite the high prevalence of plantar heel pain, the optimal treatment for this disorder remains unclear. Consequently, an alternative therapy such as dry needling is increasingly being used as an adjunctive treatment by health practitioners. Only two trials have investigated the effectiveness of dry needling for plantar heel pain, however both trials were of a low methodological quality. This manuscript describes the design of a randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. Methods Eighty community-dwelling men and woman aged over 18 years with plantar heel pain (who satisfy the inclusion and exclusion criteria will be recruited. Eligible participants with plantar heel pain will be randomised to receive either one of two interventions, (i real dry needling or (ii sham dry needling. The protocol (including needling details and treatment regimen was formulated by general consensus (using the Delphi research method using 30 experts worldwide that commonly use dry needling for plantar heel pain. Primary outcome measures will be the pain subscale of the Foot Health Status Questionnaire and "first step" pain as measured on a visual analogue scale. The secondary outcome measures will be health related quality of life (assessed using the Short Form-36 questionnaire - Version Two and depression, anxiety and stress (assessed using the Depression, Anxiety and Stress Scale - short version. Primary outcome measures will be performed at baseline, 2, 4, 6 and 12 weeks and secondary outcome measures will be performed at baseline, 6 and 12 weeks. Data will be analysed using the intention to treat principle. Conclusion This study is the first randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. The trial will

  10. Designing an implementation strategy to improve interprofessional shared decision making in sciatica: study protocol of the DISC study

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    Hofstede Stefanie N

    2012-06-01

    Full Text Available Abstract Background Sciatica is a common condition worldwide that is characterized by radiating leg pain and regularly caused by a herniated disc with nerve root compression. Sciatica patients with persisting leg pain after six to eight weeks were found to have similar clinical outcomes and associated costs after prolonged conservative treatment or surgery at one year follow-up. Guidelines recommend that the team of professionals involved in sciatica care and patients jointly decide about treatment options, so-called interprofessional shared decision making (SDM. However, there are strong indications that SDM for sciatica patients is not integrated in daily practice. We designed a study aiming to explore the barriers and facilitators associated with the everyday embedding of SDM for sciatica patients. All related relevant professionals and patients are involved to develop a tailored strategy to implement SDM for sciatica patients. Methods The study consists of two phases: identification of barriers and facilitators and development of an implementation strategy. First, barriers and facilitators are explored using semi-structured interviews among eight professionals of each (paramedical discipline involved in sciatica care (general practitioners, physical therapists, neurologists, neurosurgeons, and orthopedic surgeons. In addition, three focus groups will be conducted among patients. Second, the identified barriers and facilitators will be ranked using a questionnaire among a representative Dutch sample of 200 GPs, 200 physical therapists, 200 neurologists, all 124 neurosurgeons, 200 orthopedic surgeons, and 100 patients. A tailored team-based implementation strategy will be developed based on the results of the first phase using the principles of intervention mapping and an expert panel. Discussion Little is known about effective strategies to increase the uptake of SDM. Most implementation strategies only target a single discipline, whereas

  11. Significant Improvements in Cognitive Performance Post-Transcranial, Red/Near-Infrared Light-Emitting Diode Treatments in Chronic, Mild Traumatic Brain Injury: Open-Protocol Study

    OpenAIRE

    Naeser, Margaret A.; Zafonte, Ross; Krengel, Maxine H.; MARTIN, PAULA I; Frazier, Judith; Michael R Hamblin; Knight, Jeffrey A.; Meehan, William P.; BAKER, ERROL H.

    2014-01-01

    This pilot, open-protocol study examined whether scalp application of red and near-infrared (NIR) light-emitting diodes (LED) could improve cognition in patients with chronic, mild traumatic brain injury (mTBI). Application of red/NIR light improves mitochondrial function (especially in hypoxic/compromised cells) promoting increased adenosine triphosphate (ATP) important for cellular metabolism. Nitric oxide is released locally, increasing regional cerebral blood flow. LED therapy is noninvas...

  12. A cautionary note on the impact of protocol changes for Genome-Wide Association SNP x SNP Interaction studies: an example on ankylosing spondylitis

    OpenAIRE

    Bessonov, Kyrylo; Gusareva, Elena; Van Steen, Kristel

    2015-01-01

    Genome-wide association interaction (GWAI) studies have increased in popularity. Yet to date, no standard protocol exists. In practice, any GWAI workflow involves making choices about quality control strategy, SNP filtering, linkage disequilibrium (LD) pruning, analytic tool to model or to test for genetic interactions. Each of these can have an impact on the final epistasis findings and may affect their reproducibility in follow-up analyses. Choosing an analytic tool is not st...

  13. A participatory physical and psychosocial intervention for balancing the demands and resources among industrial workers (PIPPI): study protocol of a cluster-randomized controlled trial

    OpenAIRE

    Gupta, Nidhi; Dyrlund Wåhlin-Jacobsen, Christian; Nøhr Henriksen, Louise; Abildgaard, Johan Simonsen; NIELSEN, Karina; Holtermann, Andreas

    2015-01-01

    Background: Need for recovery and work ability are strongly associated with high employee turnover, well-being and sickness absence. However, scientific knowledge on effective interventions to improve work ability and decrease need for recovery is scarce. Thus, the present study aims to describe the background, design and protocol of a cluster randomized controlled trial evaluating the effectiveness of an intervention to reduce need for recovery and improve work ability among industrial worke...

  14. Narrative exposure therapy for immigrant children traumatized by war: study protocol for a randomized controlled trial of effectiveness and mechanisms of change

    OpenAIRE

    Kangaslampi, Samuli; Garoff, Ferdinand; Peltonen, Kirsi

    2015-01-01

    Background Millions of children worldwide suffer from posttraumatic stress disorder (PTSD) symptoms and other mental health problems due to repeated exposure to war or organized violence. Forms of cognitive-behavioral therapy (CBT) are the most commonly used treatment for PTSD and appear to be effective for children as well, but little is known about the mechanisms of change through which they achieve their effectiveness. Here we present the study protocol of a randomized controlled trial (RC...

  15. Development of new method and protocol for cryopreservation related to embryo and oocytes freezing in terms of fertilization rate: A comparative study including review of literature

    Science.gov (United States)

    Barik, Mayadhar; Bajpai, Minu; Patnaik, Santosh; Mishra, Pravash; Behera, Priyamadhaba; Dwivedi, Sada Nanda

    2016-01-01

    Background: Cryopreservation is basically related to meritorious thin samples or small clumps of cells that are cooled quickly without loss. Our main objective is to establish and formulate an innovative method and protocol development for cryopreservation as a gold standard for clinical uses in laboratory practice and treatment. The knowledge regarding usefulness of cryopreservation in clinical practice is essential to carry forward the clinical practice and research. Materials and Methods: We are trying to compare different methods of cryopreservation (in two dozen of cells) at the same time we compare the embryo and oocyte freezing interms of fertilization rate according to the International standard protocol. Results: The combination of cryoprotectants and regimes of rapid cooling and rinsing during warming often allows successful cryopreservation of biological materials, particularly cell suspensions or thin tissue samples. Examples include semen, blood, tissue samples like tumors, histological cross-sections, human eggs and human embryos. Although presently many studies have reported that the children born from frozen embryos or “frosties,” show consistently positive results with no increase in birth defects or development abnormalities is quite good enough and similar to our study (50–85%). Conclusions: We ensure that cryopreservation technology provided useful cell survivability, tissue and organ preservation in a proper way. Although it varies according to different laboratory conditions, it is certainly beneficial for patient's treatment and research. Further studies are needed for standardization and development of new protocol. PMID:27512686

  16. Development of new method and protocol for cryopreservation related to embryo and oocytes freezing in terms of fertilization rate: A comparative study including review of literature

    Science.gov (United States)

    Barik, Mayadhar; Bajpai, Minu; Patnaik, Santosh; Mishra, Pravash; Behera, Priyamadhaba; Dwivedi, Sada Nanda

    2016-01-01

    Background: Cryopreservation is basically related to meritorious thin samples or small clumps of cells that are cooled quickly without loss. Our main objective is to establish and formulate an innovative method and protocol development for cryopreservation as a gold standard for clinical uses in laboratory practice and treatment. The knowledge regarding usefulness of cryopreservation in clinical practice is essential to carry forward the clinical practice and research. Materials and Methods: We are trying to compare different methods of cryopreservation (in two dozen of cells) at the same time we compare the embryo and oocyte freezing interms of fertilization rate according to the International standard protocol. Results: The combination of cryoprotectants and regimes of rapid cooling and rinsing during warming often allows successful cryopreservation of biological materials, particularly cell suspensions or thin tissue samples. Examples include semen, blood, tissue samples like tumors, histological cross-sections, human eggs and human embryos. Although presently many studies have reported that the children born from frozen embryos or “frosties,” show consistently positive results with no increase in birth defects or development abnormalities is quite good enough and similar to our study (50–85%). Conclusions: We ensure that cryopreservation technology provided useful cell survivability, tissue and organ preservation in a proper way. Although it varies according to different laboratory conditions, it is certainly beneficial for patient's treatment and research. Further studies are needed for standardization and development of new protocol.

  17. Implementation and scientific evaluation of rehabilitative sports groups for prostate cancer patients: study protocol of the ProRehab Study

    Directory of Open Access Journals (Sweden)

    Zopf Eva M

    2012-07-01

    Full Text Available Abstract Background Although treatment regimen have improved in the last few years, prostate cancer patients following a radical prostatectomy still experience severe disease- and treatment-related side effects, including urinary incontinence, erectile dysfunction and psychological issues. Despite high incidence rates and the common adverse effects there is a lack of supportive measures for male patients and specific physical exercise recommendations for prostate cancer patients during rehabilitation or in the aftercare a