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Sample records for evident study protocol

  1. 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

  2. Where Words Fail, Music Speaks: A Mixed Method Study of an Evidence-Based Music Protocol.

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    Daniels, Ruby A; Torres, David; Reeser, Cathy

    2016-01-01

    Despite numerous studies documenting the benefits of music, hospice social workers are often unfamiliar with evidence-based music practices that may improve end of life care. This mixed method study tested an intervention to teach hospice social workers and chaplains (N = 10) an evidence-based music protocol. Participants used the evidence-based practice (EBP) for 30 days, recording 226 journal entries that described observations of 84 patients and their families. There was a significant increase in EBP knowledge (35%). Prompting behavioral and emotional responses, music was described frequently as a catalyst that facilitated deeper dialogue between patients, families, social workers, and chaplains.

  3. Study protocol

    DEFF Research Database (Denmark)

    Smith, Benjamin E; Hendrick, Paul; Bateman, Marcus

    2017-01-01

    avoidance behaviours, catastrophising, self-efficacy, sport and leisure activity participation, and general quality of life. Follow-up will be 3 and 6 months. The analysis will focus on descriptive statistics and confidence intervals. The qualitative components will follow a thematic analysis approach....... DISCUSSION: This study will evaluate the feasibility of running a definitive large-scale trial on patients with patellofemoral pain, within the NHS in the UK. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from...... this study will inform the design of a multicentre trial. TRIAL REGISTRATION: ISRCTN35272486....

  4. Study protocol

    DEFF Research Database (Denmark)

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

    2013-01-01

    , 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......, and one year after the cessation of treatment. The study is powered to quantify the impact of the combined educational, physical, and social intervention programs. Discussion RESPECT is the first population-based study to examine the effect of early rehabilitation for children with cancer, and to use...

  5. Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol.

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    Chavane, Leonardo; Merialdi, Mario; Betrán, Ana Pilar; Requejo-Harris, Jennifer; Bergel, Eduardo; Aleman, Alicia; Colomar, Mercedes; Cafferata, Maria Luisa; Carbonell, Alicia; Crahay, Beatrice; Delvaux, Therese; Geelhoed, Diederike; Gülmezoglu, Metin; Malapende, Celsa Regina; Melo, Armando; Nguyen, My Huong; Osman, Nafissa Bique; Widmer, Mariana; Temmerman, Marleen; Althabe, Fernando

    2014-05-21

    Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher.WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country. This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in

  6. Verbal protocols as methodological resources: research evidence

    Directory of Open Access Journals (Sweden)

    Alessandra Baldo

    2012-01-01

    Full Text Available This article aims at reflecting on the use of verbal protocols as a methodological resource in qualitative research, more specifically on the aspect regarded as the main limitation of a study about lexical inferencing in L2 (BALDO; VELASQUES, 2010: its subjective trait. The article begins with a brief literature review on protocols, followed by a description of the study in which they were employed as methodological resources. Based on that, protocol subjectivity is illustrated through samples of unparalleled data classification, carried out independently by two researchers. In the final section, the path followed to minimize the problem is presented, intending to contribute to improve efficiency in the use of verbal protocols in future research.

  7. Protocols for pressure ulcer prevention: are they evidence-based?

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    Chaves, Lidice M; Grypdonck, Mieke H F; Defloor, Tom

    2010-03-01

    This study is a report of a study to determine the quality of protocols for pressure ulcer prevention in home care in the Netherlands. If pressure ulcer prevention protocols are evidence-based and practitioners use them correctly in practice, this will result a reduction in pressure ulcers. Very little is known about the evidence-based content and quality of the pressure ulcer prevention protocols. In 2008, current pressure ulcer prevention protocols from 24 home-care agencies in the Netherlands were evaluated. A checklist developed and validated by two pressure ulcer prevention experts was used to assess the quality of the protocols, and weighted and unweighted quality scores were computed and analysed using descriptive statistics. The 24 pressure ulcer prevention protocols had a mean weighted quality score of 63.38 points out of a maximum of 100 (sd 5). The importance of observing the skin at the pressure points at least once a day was emphasized in 75% of the protocols. Only 42% correctly warned against the use of materials that were 'less effective or that could potentially cause harm'. Pressure ulcer prevention commands a reasonable amount of attention in home care, but the incidence of pressure ulcers and lack of a consistent, standardized document for use in actual practice indicate a need for systematic implementation of national pressure ulcer prevention standards in the Netherlands to ensure adherence to the established protocols.

  8. Camino Verde (The Green Way: evidence-based community mobilisation for dengue control in Nicaragua and Mexico: feasibility study and study protocol for a randomised controlled trial

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    Neil Andersson

    2017-05-01

    Full Text Available Abstract Background Since the Aedes aegypti mosquitoes that transmit dengue virus can breed in clean water, WHO-endorsed vector control strategies place sachets of organophosphate pesticide, temephos (Abate, in household water storage containers. These and other pesticide-dependent approaches have failed to curb the spread of dengue and multiple dengue virus serotypes continue to spread throughout tropical and subtropical regions worldwide. A feasibility study in Managua, Nicaragua, generated instruments, intervention protocols, training schedules and impact assessment tools for a cluster randomised controlled trial of community-based approaches to vector control comprising an alternative strategy for dengue prevention and control in Nicaragua and Mexico. Methods/Design The Camino Verde (Green Way is a pragmatic parallel group trial of pesticide-free dengue vector control, adding effectiveness to the standard government dengue control. A random sample from the most recent census in three coastal regions of Guerrero state in Mexico will generate 90 study clusters and the equivalent sampling frame in Managua, Nicaragua will generate 60 clusters, making a total of 150 clusters each of 137–140 households. After a baseline study, computer-driven randomisation will allocate to intervention one half of the sites, stratified by country, evidence of recent dengue virus infection in children aged 3–9 years and, in Nicaragua, level of community organisation. Following a common evidence-based education protocol, each cluster will develop and implement its own collective interventions including house-to-house visits, school-based programmes and inter-community visits. After 18 months, a follow-up study will compare dengue history, serological evidence of recent dengue virus infection (via measurement of anti-dengue virus antibodies in saliva samples and entomological indices between intervention and control sites. Discussion Our hypothesis is that

  9. Camino Verde (The Green Way): evidence-based community mobilisation for dengue control in Nicaragua and Mexico: feasibility study and study protocol for a randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil; Arostegui, Jorge; Nava-Aguilera, Elizabeth; Harris, Eva; Ledogar, Robert J

    2017-05-30

    Since the Aedes aegypti mosquitoes that transmit dengue virus can breed in clean water, WHO-endorsed vector control strategies place sachets of organophosphate pesticide, temephos (Abate), in household water storage containers. These and other pesticide-dependent approaches have failed to curb the spread of dengue and multiple dengue virus serotypes continue to spread throughout tropical and subtropical regions worldwide. A feasibility study in Managua, Nicaragua, generated instruments, intervention protocols, training schedules and impact assessment tools for a cluster randomised controlled trial of community-based approaches to vector control comprising an alternative strategy for dengue prevention and control in Nicaragua and Mexico. The Camino Verde (Green Way) is a pragmatic parallel group trial of pesticide-free dengue vector control, adding effectiveness to the standard government dengue control. A random sample from the most recent census in three coastal regions of Guerrero state in Mexico will generate 90 study clusters and the equivalent sampling frame in Managua, Nicaragua will generate 60 clusters, making a total of 150 clusters each of 137-140 households. After a baseline study, computer-driven randomisation will allocate to intervention one half of the sites, stratified by country, evidence of recent dengue virus infection in children aged 3-9 years and, in Nicaragua, level of community organisation. Following a common evidence-based education protocol, each cluster will develop and implement its own collective interventions including house-to-house visits, school-based programmes and inter-community visits. After 18 months, a follow-up study will compare dengue history, serological evidence of recent dengue virus infection (via measurement of anti-dengue virus antibodies in saliva samples) and entomological indices between intervention and control sites. Our hypothesis is that informed community mobilisation adds effectiveness in controlling

  10. An evidence based blunt trauma protocol

    NARCIS (Netherlands)

    Vugt, R. van; Kool, D.R.; Lubeek, S.F.K.; Dekker, H.M.; Brink, M.; Deunk, J.; Edwards, M.J.R.

    2013-01-01

    OBJECTIVE: Currently CT is rapidly implemented in the evaluation of trauma patients. In anticipation of a large international multicentre trial, this study's aim was to evaluate the clinical feasibility of a new diagnostic protocol, used for the primary radiological evaluation in adult blunt

  11. Publication trends of study protocols in rehabilitation.

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    Jesus, Tiago S; Colquhoun, Heather L

    2017-09-04

    Growing evidence points for the need to publish study protocols in the health field. To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. Observational study using publication data and its indexation in PubMed. Not applicable. Not applicable. PubMed was searched with appropriate combinations of Medical Subject Headings up to December 2014. The effective presence of study protocols was manually screened. Regression models analyzed the yearly growth of publications. Two-sample Z-tests analyzed whether the proportion of Systematic Reviews (SRs) and Randomized Controlled Trials (RCTs) among study protocols differed from that of the same designs for the broader rehabilitation research. Up to December 2014, 746 publications of rehabilitation study protocols were identified, with an exponential growth since 2005 (r2=0.981; p<0.001). RCT protocols were the most common among rehabilitation study protocols (83%), while RCTs were significantly more prevalent among study protocols than among the broader rehabilitation research (83% vs. 35.8%; p<0.001). For SRs, the picture was reversed: significantly less common among study protocols (2.8% vs. 9.3%; p<0.001). Funding was more often reported by rehabilitation study protocols than the broader rehabilitation research (90% vs. 53.1%; p<0.001). Rehabilitation journals published a significantly lower share of rehabilitation study protocols than they did for the broader rehabilitation research (1.8% vs.16.7%; p<0.001). Identifying the reasons for these discrepancies and reverting unwarranted disparities (e.g. low rate of publication for rehabilitation SR protocols) are likely new avenues for rehabilitation research and its publication. SRs, particularly those aggregating RCT results, are considered the best standard of evidence to guide rehabilitation clinical practice; however, that standard can be improved

  12. Organizational supports used by private child and family serving agencies to facilitate evidence use: a mixed methods study protocol.

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    Chuang, Emmeline; Collins-Camargo, Crystal; McBeath, Bowen

    2017-04-08

    Challenges to evidence use are well documented. Less well understood are the formal supports-e.g., technical infrastructure, inter-organizational relationships-organizations may put in place to help overcome these challenges. This study will identify supports for evidence use currently used by private child and family serving agencies delivering publicly funded behavioral health and/or human services; examine contextual, organizational, and managerial factors associated with use of such supports; and determine how identified supports affect evidence use by staff at multiple levels of the organization. We will use a sequential explanatory mixed methods design, with study activities occurring in two sequential phases: In phase 1, quantitative survey data collected from managers of private child and family serving agencies in six states (CA, IN, KY, MO, PA, and WI) and analyzed using both regression and qualitative comparative analysis (QCA) will identify organizational supports currently being used to facilitate evidence use and examine the contextual, organizational, and managerial factors associated with the use of such supports. In phase 2, data from phase 1 will be used to select a purposive sample of 12 agencies for in-depth case studies. In those 12 agencies, semi-structured interviews with key informants and managers, focus groups with frontline staff, and document analysis will provide further insight into agencies' motivation for investing in organizational supports for evidence use and the facilitators and barriers encountered in doing so. Semi-structured interviews with managers and focus groups with frontline staff will also assess whether and how identified supports affect evidence use at different levels of the organization (senior executives, middle managers, frontline supervisors, and frontline staff). Within- and between-case analyses supplemented by QCA will identify combinations of factors associated with the highest and lowest levels of staff

  13. Perceptions, attitudes and knowledge of evidence-based medicine in primary care in Spain: a study protocol

    Directory of Open Access Journals (Sweden)

    Carrillo Ricard

    2009-05-01

    Full Text Available Abstract Background The philosophy of evidence-based medicine (EBM was introduced in the early 90s as a new approach to the practice of medicine, using the best available evidence to make decisions about health care. Despite ongoing controversy, EBM has developed enormously and physicians' attitude towards it is generally positive. Nevertheless, in Spain little is known about this topic. We will therefore undertake a study to explore perceptions, attitudes and knowledge about EBM among primary care physicians. Methods and design A mixed-method study combining qualitative and quantitative designs will target family practitioners in Spain with the objective of evaluating current attitudes and perceptions about evidence-based medicine. The project will consist of two phases: a first phase running focus groups to identify perceptions and attitudes of participants, and a second phase assessing their attitudes and knowledge about EBM by means of a survey. Both phases will explore these issues in three different subgroups: family practitioners, with or without previous formal education in EBM; members of working groups that formulate healthcare recommendations; and physicians in charge of training family practice residents. Additionally, we will undertake a systematic review to identify and synthesize the available evidence on this topic. Discussion The study will identify and gain insight into the perceived problems and barriers to the practice of evidence-based medicine among general practitioners in Spain. The project will also evaluate the main knowledge gaps and training needs, and explore how evidence-based medicine is being taught to family medicine residents, the medical practitioners of the future. Our results will aid researchers and health care planners in developing strategies to improve the practice of evidence-based medicine in our country.

  14. An audience research study to disseminate evidence about comprehensive state mental health parity legislation to US State policymakers: protocol.

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    Purtle, Jonathan; Lê-Scherban, Félice; Shattuck, Paul; Proctor, Enola K; Brownson, Ross C

    2017-06-26

    A large proportion of the US population has limited access to mental health treatments because insurance providers limit the utilization of mental health services in ways that are more restrictive than for physical health services. Comprehensive state mental health parity legislation (C-SMHPL) is an evidence-based policy intervention that enhances mental health insurance coverage and improves access to care. Implementation of C-SMHPL, however, is limited. State policymakers have the exclusive authority to implement C-SMHPL, but sparse guidance exists to inform the design of strategies to disseminate evidence about C-SMHPL, and more broadly, evidence-based treatments and mental illness, to this audience. The aims of this exploratory audience research study are to (1) characterize US State policymakers' knowledge and attitudes about C-SMHPL and identify individual- and state-level attributes associated with support for C-SMHPL; and (2) integrate quantitative and qualitative data to develop a conceptual framework to disseminate evidence about C-SMHPL, evidence-based treatments, and mental illness to US State policymakers. The study uses a multi-level (policymaker, state), mixed method (QUAN→qual) approach and is guided by Kingdon's Multiple Streams Framework, adapted to incorporate constructs from Aarons' Model of Evidence-Based Implementation in Public Sectors. A multi-modal survey (telephone, post-mail, e-mail) of 600 US State policymakers (500 legislative, 100 administrative) will be conducted and responses will be linked to state-level variables. The survey will span domains such as support for C-SMHPL, knowledge and attitudes about C-SMHPL and evidence-based treatments, mental illness stigma, and research dissemination preferences. State-level variables will measure factors associated with C-SMHPL implementation, such as economic climate and political environment. Multi-level regression will determine the relative strength of individual- and state

  15. Population-centered Risk- and Evidence-based Dental Interprofessional Care Team (PREDICT): study protocol for a randomized controlled trial.

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    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

    2015-06-20

    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. This is a parallel-group cluster randomized controlled trial. Fourteen rural Oregon counties with a publicly insured (Medicaid) population of 82,000 children (0 to 21 years old) and pregnant women served by a managed dental care organization are randomized into test and control counties. In the test intervention (PREDICT), allied dental personnel provide screening and preventive services in community settings and case managers serve as patient navigators to arrange referrals of children who need dentist services. The delivery system intervention is paired with a compensation system for high performance (pay-for-performance) with efficient performance monitoring. PREDICT focuses on the following: 1) identifying eligible children and gaining caregiver consent for services in community settings (for example, schools); 2) providing risk-based preventive and caries stabilization services efficiently at these settings; 3) providing curative care in dental clinics; and 4) incentivizing local delivery teams to meet performance benchmarks. In the control intervention, care is delivered in dental offices without performance incentives. The primary outcome is the prevalence of untreated dental caries. Other outcomes are related to process, structure and cost. Data are collected through patient and staff surveys, clinical examinations, and the review of health and administrative records. If effective, PREDICT is expected to substantially reduce disparities in dental care and oral health. PREDICT can be

  16. Better evidence for earlier assessment and surgical intervention for refractory epilepsy (The BEST study): a mixed methods study protocol.

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    Rapport, Frances; Shih, Patti; Mitchell, Rebecca; Nikpour, Armin; Bleasel, Andrew; Herkes, Geoffrey; Vagholkar, Sanjyot; Mumford, Virginia

    2017-08-21

    One-third of patients with refractory epilepsy may be candidates for resective surgery, which can lead to positive clinical outcomes if efficiently managed. In Australia, there is currently between a 6-month and 2-year delay for patients who are candidates for respective epilepsy surgery from the point of referral for surgical assessment to the eventual surgical intervention. This is a major challenge for implementation of effective treatment for individuals who could potentially benefit from surgery. This study examines implications of delays following the point of eligibility for surgery, in the assessment and treatment of patients, and the factors causing treatment delays. Mixed methods design: Observations of qualitative consultations, patient and healthcare professional interviews, and health-related quality of life assessments for a group of 10 patients and six healthcare professionals (group 1); quantitative retrospective medical records' reviews examining longitudinal outcomes for 50 patients assessed for, or undergoing, resective surgery between 2014 and 2016 (group 2); retrospective epidemiological study of all individuals hospitalised with a diagnosis of epilepsy in New South Wales (NSW) in the last 5 years (2012-2016; approximately 11 000 hospitalisations per year, total 55 000), examining health services' use and treatment for individuals with epilepsy, including refractory surgery outcomes (group 3). Ethical approval has been granted by the North Sydney Local Health District Human Research Ethics Committee (HREC/17/HAWKE/22) and the NSW Population & Health Services Research Ethics Committee (HREC/16/CIPHS/1). Results will be disseminated through publications, reports and conference presentations to patients and families, health professionals and researchers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. Implementation of evidence on the nurse-patient relationship in psychiatric wards through a mixed method design: study protocol.

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    Moreno-Poyato, Antonio R; Delgado-Hito, Pilar; Suárez-Pérez, Raquel; Leyva-Moral, Juan M; Aceña-Domínguez, Rosa; Carreras-Salvador, Regina; Roldán-Merino, Juan F; Lluch-Canut, Teresa; Montesó-Curto, Pilar

    2017-01-01

    Psychiatric nurses are aware of the importance of the therapeutic relationship in psychiatric units. Nevertheless, a review of the scientific evidence indicates that theoretical knowledge alone is insufficient to establish an adequate therapeutic alliance. Therefore, strategies are required to promote changes to enhance the establishment of the working relationship. The aims of the study are to generate changes in how nurses establish the therapeutic relationship in acute psychiatric units, based on participative action research and to evaluate the effectiveness of the implementation of evidence through this method. The study will use a mixed method design. Qualitative methodology, through participative action research, will be employed to implement scientific evidence on the therapeutic relationship. A quasi-experimental, one-group, pre-test/post-test design will also be used to quantitatively measure the effectiveness of the implementation of the evidence. Participants will consist of nurses and patients from two psychiatric units in Barcelona. Nurses will be selected by theoretical sampling, and patients assigned to each nurses will be selected by consecutive sampling. Qualitative data will be gathered through discussion groups and field diaries. Quantitative data will be collected through the Working Alliance Inventory and the Interpersonal Reactivity Index. Qualitative data will be analysed through the technique of content analysis and quantitative data through descriptive and inferential statistics. This study will help to understand the process of change in a nursing team working in an inpatient psychiatric ward and will allow nurses to generate knowledge, identify difficulties, and establish strategies to implement change, as well as to assess whether the quality of the care they provide shows a qualitative improvement.

  18. Exploring multi-level system factors facilitating educator training and implementation of evidence-based practices (EBP): a study protocol.

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    Stahmer, Aubyn C; Suhrheinrich, Jessica; Schetter, Patricia L; McGee Hassrick, Elizabeth

    2018-01-08

    This study examines how system-wide (i.e., region, district, and school) mechanisms such as leadership support, training requirements, structure, collaboration, and education affect the use of evidence-based practices (EBPs) in schools and how this affects the outcomes for students with autism spectrum disorder (ASD). Despite growing evidence for the positive effects of EBPs for ASD, these practices are not consistently or effectively used in schools. Although special education programs are mandated to use EBPs, there are very few evidence-based methods for selecting, implementing, and sustaining EBPs. Research focuses primarily on teacher training, without attention to contextual factors (e.g., implementation climate, attitudes toward EBPs, resource allocation, and social networks) that may impact outcomes. Using an implementation science framework, this project will prospectively examine relations between system-wide factors and teachers' use of EBPs and student education outcomes. Survey data will be collected from approximately 85 regional special education directors, 170 regional program specialists, 265 district special education directors, 265 behavior specialists, 925 school principals, 3538 special education teachers, and 2700 paraprofessionals. Administrative data for the students with ASD served by participating teachers will be examined. A total of 79 regional-, district-, and school-level personnel will also participate in social network interviews. Mixed methods, including surveys, administrative data, and observational checklists, will be used to gather in-depth information about system-wide malleable factors that relate to positive teacher implementation of EBPs and student outcomes. Multi-level modeling will be used to assess system-wide malleable factors related to EBP implementation which will be linked to the trainer, teacher, and student outcomes and examined based on moderators (e.g., district size, Special Education Local Plan Area structure

  19. Study protocol of psychometric properties of the Spanish translation of a competence test in evidence based practice: The Fresno test

    Directory of Open Access Journals (Sweden)

    Villafafila-Ferrero Rosa

    2009-02-01

    Full Text Available Abstract Background There are few high-quality instruments for evaluating the effectiveness of Evidence-Based Practice (EBP curricula with objective outcomes measures. The Fresno test is an instrument that evaluates most of EBP steps with a high reliability and validity in the English original version. The present study has the aims to translate the Fresno questionnaire into Spanish and its subsequent validation to ensure the equivalence of the Spanish version against the English original. Methods and design The questionnaire will be translated with the back translation technique and tested in Primary Care Teaching Units in Catalonia (PCTU. Participants will be: (a tutors of Family Medicine residents (expert group; (b Family Medicine residents in their second year of the Family Medicine training program (novice group, and (c Family Medicine physicians (intermediate group. The questionnaire will be administered before and after an educational intervention. The educational intervention will be an interactive four half-day sessions designed to develop the knowledge and skills required to EBP. Responsiveness statistics used in the analysis will be the effect size, the standardised response mean and Guyatt's method. For internal consistency reliability, two measures will be used: corrected item-total correlations and Cronbach's alpha. Inter-rater reliability will be tested using Kappa coefficient for qualitative items and intra-class correlation coefficient for quantitative items and the overall score. Construct validity, item difficulty, item discrimination and feasibility will be determined. Discussion The validation of the Fresno questionnaire into different languages will enable the expansion of the questionnaire, as well as allowing comparison between countries and the evaluation of different teaching models.

  20. Study protocol of psychometric properties of the Spanish translation of a competence test in evidence based practice: the Fresno test.

    Science.gov (United States)

    Argimon-Pallàs, Josep M; Flores-Mateo, Gemma; Jiménez-Villa, Josep; Pujol-Ribera, Enriqueta; Foz, Gonçal; Bundó-Vidiella, Magda; Juncosa, Sebastià; Fuentes-Bellido, Cruz M; Pérez-Rodríguez, Belén; Margalef-Pallarès, Francesc; Villafafila-Ferrero, Rosa; Forès-Garcia, Dolors; Roman-Martínez, Josep; Vilert-Garroga, Esther

    2009-02-24

    There are few high-quality instruments for evaluating the effectiveness of Evidence-Based Practice (EBP) curricula with objective outcomes measures. The Fresno test is an instrument that evaluates most of EBP steps with a high reliability and validity in the English original version. The present study has the aims to translate the Fresno questionnaire into Spanish and its subsequent validation to ensure the equivalence of the Spanish version against the English original. The questionnaire will be translated with the back translation technique and tested in Primary Care Teaching Units in Catalonia (PCTU). Participants will be: (a) tutors of Family Medicine residents (expert group); (b) Family Medicine residents in their second year of the Family Medicine training program (novice group), and (c) Family Medicine physicians (intermediate group). The questionnaire will be administered before and after an educational intervention. The educational intervention will be an interactive four half-day sessions designed to develop the knowledge and skills required to EBP. Responsiveness statistics used in the analysis will be the effect size, the standardised response mean and Guyatt's method. For internal consistency reliability, two measures will be used: corrected item-total correlations and Cronbach's alpha. Inter-rater reliability will be tested using Kappa coefficient for qualitative items and intra-class correlation coefficient for quantitative items and the overall score. Construct validity, item difficulty, item discrimination and feasibility will be determined. The validation of the Fresno questionnaire into different languages will enable the expansion of the questionnaire, as well as allowing comparison between countries and the evaluation of different teaching models.

  1. Review of Evidence for Adult Diabetic Ketoacidosis Management Protocols

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    Tara T. T. Tran

    2017-06-01

    Full Text Available BackgroundDiabetic ketoacidosis (DKA is an endocrine emergency with associated risk of morbidity and mortality. Despite this, DKA management lacks strong evidence due to the absence of large randomised controlled trials (RCTs.ObjectiveTo review existing studies investigating inpatient DKA management in adults, focusing on intravenous (IV fluids; insulin administration; potassium, bicarbonate, and phosphate replacement; and DKA management protocols and impact of DKA resolution rates on outcomes.MethodsOvid Medline searches were conducted with limits “all adult” and published between “1973 to current” applied. National consensus statements were also reviewed. Eligibility was determined by two reviewers’ assessment of title, abstract, and availability.ResultsA total of 85 eligible articles published between 1973 and 2016 were reviewed. The salient findings were (i Crystalloids are favoured over colloids though evidence is lacking. The preferred crystalloid and hydration rates remain contentious. (ii IV infusion of regular human insulin is preferred over the subcutaneous route or rapid acting insulin analogues. Administering an initial IV insulin bolus before low-dose insulin infusions obviates the need for supplemental insulin. Consensus-statements recommend fixed weight-based over “sliding scale” insulin infusions although evidence is weak. (iii Potassium replacement is imperative although no trials compare replacement rates. (iv Bicarbonate replacement offers no benefit in DKA with pH > 6.9. In severe metabolic acidosis with pH < 6.9, there is lack of both data and consensus regarding bicarbonate administration. (v There is no evidence that phosphate replacement offers outcome benefits. Guidelines consider replacement appropriate in patients with cardiac dysfunction, anaemia, respiratory depression, or phosphate levels <0.32 mmol/L. (vi Upon resolution of DKA, subcutaneous insulin is recommended with IV insulin infusions

  2. Diffusion of an evidence-based smoking cessation intervention through Facebook: a randomised controlled trial study protocol.

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    Cobb, Nathan K; Jacobs, Megan A; Saul, Jessie; Wileyto, E Paul; Graham, Amanda L

    2014-01-21

    Online social networks represent a potential mechanism for the dissemination of health interventions including smoking cessation; however, which elements of an intervention determine diffusion between participants is unclear. Diffusion is frequently measured using R, the reproductive rate, which is determined by the duration of use (t), the 'contagiousness' of an intervention (β) and a participant's total contacts (z). We have developed a Facebook 'app' that allows us to enable or disable various components designed to impact the duration of use (expanded content, proactive contact), contagiousness (active and passive sharing) and number of contacts (use by non-smoker supporters). We hypothesised that these elements would be synergistic in their impact on R, while including non-smokers would induce a 'carrier' state allowing the app to bridge clusters of smokers. This study is a fractional factorial, randomised control trial of the diffusion of a Facebook application for smoking cessation. Participants recruited through online advertising are randomised to 1 of 12 cells and serve as 'seed' users. All user interactions are tracked, including social interactions with friends. Individuals installing the application that can be traced back to a seed participant are deemed 'descendants' and form the outcome of interest. Analysis will be conducted using Poisson regression, with event count as the outcome and the number of seeds in the cell as the exposure. The results will be reported as a baseline R0 for the reference group, and incidence rate ratio for the remainder of predictors. This study uses an abbreviated consent process designed to minimise barriers to adoption and was deemed to be minimal risk by the Institutional Review Board (IRB). Results will be disseminated through traditional academic literature as well as social media. If feasible, anonymised data and underlying source code are intended to be made available under an open source license. NCT01746472.

  3. Diffusion of an evidence-based smoking cessation intervention through Facebook: a randomised controlled trial study protocol

    Science.gov (United States)

    Cobb, Nathan K; Jacobs, Megan A; Saul, Jessie; Wileyto, E Paul; Graham, Amanda L

    2014-01-01

    Introduction Online social networks represent a potential mechanism for the dissemination of health interventions including smoking cessation; however, which elements of an intervention determine diffusion between participants is unclear. Diffusion is frequently measured using R, the reproductive rate, which is determined by the duration of use (t), the ‘contagiousness’ of an intervention (β) and a participant's total contacts (z). We have developed a Facebook ‘app’ that allows us to enable or disable various components designed to impact the duration of use (expanded content, proactive contact), contagiousness (active and passive sharing) and number of contacts (use by non-smoker supporters). We hypothesised that these elements would be synergistic in their impact on R, while including non-smokers would induce a ‘carrier’ state allowing the app to bridge clusters of smokers. Methods and analysis This study is a fractional factorial, randomised control trial of the diffusion of a Facebook application for smoking cessation. Participants recruited through online advertising are randomised to 1 of 12 cells and serve as ‘seed’ users. All user interactions are tracked, including social interactions with friends. Individuals installing the application that can be traced back to a seed participant are deemed ‘descendants’ and form the outcome of interest. Analysis will be conducted using Poisson regression, with event count as the outcome and the number of seeds in the cell as the exposure. Results The results will be reported as a baseline R0 for the reference group, and incidence rate ratio for the remainder of predictors. Ethics and Dissemination This study uses an abbreviated consent process designed to minimise barriers to adoption and was deemed to be minimal risk by the Institutional Review Board (IRB). Results will be disseminated through traditional academic literature as well as social media. If feasible, anonymised data and underlying

  4. Preventive evidence into practice (PEP study: implementation of guidelines to prevent primary vascular disease in general practice protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Harris Mark F

    2013-01-01

    Full Text Available Abstract Background There are significant gaps in the implementation and uptake of evidence-based guideline recommendations for cardiovascular disease (CVD and diabetes in Australian general practice. This study protocol describes the methodology for a cluster randomised trial to evaluate the effectiveness of a model that aims to improve the implementation of these guidelines in Australian general practice developed by a collaboration between researchers, non-government organisations, and the profession. Methods We hypothesise that the intervention will alter the behaviour of clinicians and patients resulting in improvements of recording of lifestyle and physiological risk factors (by 20% and increased adherence to guideline recommendations for: the management of CVD and diabetes risk factors (by 20%; and lifestyle and physiological risk factors of patients at risk (by 5%. Thirty-two general practices will be randomised in a 1:1 allocation to receive either the intervention or continue with usual care, after stratification by state. The intervention will be delivered through: small group education; audit of patient records to determine preventive care; and practice facilitation visits adapted to the needs of the practices. Outcome data will be extracted from electronic medical records and patient questionnaires, and qualitative evaluation from provider and patient interviews. Discussion We plan to disseminate study findings widely and directly inform implementation strategies by governments, professional bodies, and non-government organisations including the partner organisations.

  5. A prospective multiple case study of the impact of emerging scientific evidence on established colorectal cancer screening programs: a study protocol.

    Science.gov (United States)

    Geddie, Hannah; Dobrow, Mark J; Hoch, Jeffrey S; Rabeneck, Linda

    2012-06-01

    Health-policy decision making is a complex and dynamic process, for which strong evidentiary support is required. This includes scientifically produced research, as well as information that relates to the context in which the decision takes place. Unlike scientific evidence, this "contextual evidence" is highly variable and often includes information that is not scientifically produced, drawn from sources such as political judgement, program management experience and knowledge, or public values. As the policy decision-making process is variable and difficult to evaluate, it is often unclear how this heterogeneous evidence is identified and incorporated into "evidence-based policy" decisions. Population-based colorectal cancer screening poses an ideal context in which to examine these issues. In Canada, colorectal cancer screening programs have been established in several provinces over the past five years, based on the fecal occult blood test (FOBT) or the fecal immunochemical test. However, as these programs develop, new scientific evidence for screening continues to emerge. Recently published randomized controlled trials suggest that the use of flexible sigmoidoscopy for population-based screening may pose a greater reduction in mortality than the FOBT. This raises the important question of how policy makers will address this evidence, given that screening programs are being established or are already in place. This study will examine these issues prospectively and will focus on how policy makers monitor emerging scientific evidence and how both scientific and contextual evidence are identified and applied for decisions about health system improvement. This study will employ a prospective multiple case study design, involving participants from Ontario, Alberta, Manitoba, Nova Scotia, and Quebec. In each province, data will be collected via document analysis and key informant interviews. Documents will include policy briefs, reports, meeting minutes, media

  6. The DOMUS study protocol

    DEFF Research Database (Denmark)

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

    2014-01-01

    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: Clinicaltrials......BACKGROUND: The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death. The Danish Palliative Care Trial (DOMUS) aims to investigate...... psychological intervention for patients and caregivers at home or b) standard care alone. Inclusion criteria are incurable cancer with no or limited antineoplastic treatment options. DISCUSSION: Programs that facilitate transition from hospital treatment to SPC at home for patients with incurable cancer can...

  7. Management of the infertile couple: an evidence-based protocol

    Directory of Open Access Journals (Sweden)

    Kamel Remah M

    2010-03-01

    Full Text Available Abstract Background Infertility is defined as inability of a couple to conceive naturally after one year of regular unprotected sexual intercourse. It remains a major clinical and social problem, affecting perhaps one couple in six. Evaluation usually starts after 12 months; however it may be indicated earlier. The most common causes of infertility are: male factor such as sperm abnormalities, female factor such as ovulation dysfunction and tubal pathology, combined male and female factors and unexplained infertility. Objectives The aim of this study is to provide the healthcare professionals an evidence-based management protocol for infertile couples away from medical information overload. Methods A comprehensive review where the literature was searched for "Management of infertility and/or infertile couples" at library website of University of Bristol (MetaLib by using a cross-search of different medical databases besides the relevant printed medical journals and periodicals. Guidelines and recommendations were retrieved from the best evidence reviews such as that from the American College of Obstetricians and Gynaecologists (ACOG, American Society for Reproductive Medicine (ASRM, Canadian Fertility and Andrology Society (CFAS, and Royal College of Obstetricians and Gynaecologists (RCOG. Results A simple guide for the clinicians to manage the infertile couples. Conclusions The study deploys a new strategy to translate the research findings and evidence-base recommendations into a simplified focused guide to be applied on routine daily practice. It is an approach to disseminate the recommended medical care for infertile couple to the practicing clinicians.

  8. Study protocol: Addressing evidence and context to facilitate transfer and uptake of consultation recording use in oncology: A knowledge translation implementation study

    Directory of Open Access Journals (Sweden)

    Ruether J Dean

    2011-03-01

    Full Text Available Abstract Background The time period from diagnosis to the end of treatment is challenging for newly diagnosed cancer patients. Patients have a substantial need for information, decision aids, and psychosocial support. Recordings of initial oncology consultations improve information recall, reduce anxiety, enhance patient satisfaction with communication, and increase patients' perceptions that the essential aspects of their disease and treatment have been addressed during the consultation. Despite the research evidence supporting the provision of consultation recordings, uptake of this intervention into oncology practice has been slow. The primary aim of this project is to conduct an implementation study to explicate the contextual factors, including use of evidence, that facilitate and impede the transfer and uptake of consultation-recording use in a sample of patients newly diagnosed with breast or prostate cancer. Methods Sixteen oncologists from cancer centres in three Canadian cities will participate in this three-phase study. The preimplementation phase will be used to identify and address those factors that are fundamental to facilitating the smooth adoption and delivery of the intervention during the implementation phase. During the implementation phase, breast and prostate cancer patients will receive a recording of their initial oncology consultation to take home. Patient interviews will be conducted in the days following the consultation to gather feedback on the benefits of the intervention. Patients will complete the Digital Recording Use Semi-Structured Interview (DRUSSI and be invited to participate in focus groups in which their experiences with the consultation recording will be explored. Oncologists will receive a summary letter detailing the benefits voiced by their patients. The postimplementation phase includes a conceptual framework development meeting and a seven-point dissemination strategy. Discussion Consultation

  9. An evidence-based gamified mHealth intervention for overweight young adults with maladaptive eating habits: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Podina, Ioana R; Fodor, Liviu A; Cosmoiu, Ana; Boian, Rareș

    2017-12-12

    Cognitive behavior therapy (CBT) is the first-line of treatment for overweight and obesity patients whose problems originate in maladaptive eating habits (e.g., emotional eating). However, in-person CBT is currently difficult to access by large segments of the population. The proposed SIGMA intervention (i.e., the Self-help, Integrated, and Gamified Mobile-phone Application) is a mHealth intervention based on CBT principles. It specifically targets overweight young adults with underlying maladaptive behaviors and cognitions regarding food. The SIGMA app was designed as a serious game and intended to work as a standalone app for weight maintenance or alongside a calorie-restrictive diet for weight loss. It uses a complex and novel scoring system that allows points earned within the game to be supplemented by points earned during outdoor activities with the help of an embedded pedometer. The efficacy of the SIGMA mHealth intervention will be investigated within a randomized, placebo-controlled trial. The intervention will be set to last 2 months with a 3-month follow-up. Selected participants will be young overweight adults with non-clinical maladaptive eating habits embodied by food cravings, binge eating, and emotional eating. The primary outcomes will be represented by changes in (1) self-reported maladaptive thoughts related to eating and body weight, (2) self-reported maladaptive eating behaviors in the range of urgent food cravings, emotional eating or binge eating, (3) as well as biased attentional processing of food items as indexed by reaction times. Secondary outcomes will be represented by changes in weight, Body Mass Index, general mood, and physical activity as indexed by the number of steps per day. Through an evidence-based cognitive behavioral approach and a user-friendly game interface, the SIGMA intervention offers a significant contribution to the development of a cost-effective and preventive self-help tool for young overweight adults with

  10. Making sense of evidence in management decisions: the role of research-based knowledge on innovation adoption and implementation in healthcare. study protocol.

    Science.gov (United States)

    Kyratsis, Yiannis; Ahmad, Raheelah; Holmes, Alison

    2012-03-21

    We know that patient care can be improved by implementing evidence-based innovations and applying research findings linked to good practice. Successfully implementing innovations in complex organisations, such as the UK's National Health Service (NHS), is often challenging as multiple contextual dynamics mediate the process. Research studies have explored the challenges of introducing innovations into healthcare settings and have contributed to a better understanding of why potentially useful innovations are not always implemented in practice, even if backed by strong evidence. Mediating factors include health policy and health system influences, organisational factors, and individual and professional attitudes, including decision makers' perceptions of innovation evidence. There has been limited research on how different forms of evidence are accessed and utilised by organisational decision makers during innovation adoption. We also know little about how diverse healthcare professionals (clinicians, administrators) make sense of evidence and how this collective sensemaking mediates the uptake of innovations. The study will involve nine comparative case study sites of acute care organisations grouped into three regional clusters across England. Each of the purposefully selected sites represents a variety of trust types and organisational contexts. We will use qualitative methods, in-depth interviews, observation of key meetings, and systematic analysis of relevant secondary data to understand the rationale and challenges involved in sourcing and utilising innovation evidence in the empirical setting of infection prevention and control. We will use theories of innovation adoption and sensemaking in organisations to interpret the data. The research will provide lessons for the uptake and continuous use of innovations in the English and international health systems. Unlike most innovation studies, which involve single-level analysis, our study will explore the

  11. Making sense of evidence in management decisions: the role of research-based knowledge on innovation adoption and implementation in healthcare. study protocol

    Directory of Open Access Journals (Sweden)

    Kyratsis Yiannis

    2012-03-01

    Full Text Available Abstract Background We know that patient care can be improved by implementing evidence-based innovations and applying research findings linked to good practice. Successfully implementing innovations in complex organisations, such as the UK's National Health Service (NHS, is often challenging as multiple contextual dynamics mediate the process. Research studies have explored the challenges of introducing innovations into healthcare settings and have contributed to a better understanding of why potentially useful innovations are not always implemented in practice, even if backed by strong evidence. Mediating factors include health policy and health system influences, organisational factors, and individual and professional attitudes, including decision makers' perceptions of innovation evidence. There has been limited research on how different forms of evidence are accessed and utilised by organisational decision makers during innovation adoption. We also know little about how diverse healthcare professionals (clinicians, administrators make sense of evidence and how this collective sensemaking mediates the uptake of innovations. Methods The study will involve nine comparative case study sites of acute care organisations grouped into three regional clusters across England. Each of the purposefully selected sites represents a variety of trust types and organisational contexts. We will use qualitative methods, in-depth interviews, observation of key meetings, and systematic analysis of relevant secondary data to understand the rationale and challenges involved in sourcing and utilising innovation evidence in the empirical setting of infection prevention and control. We will use theories of innovation adoption and sensemaking in organisations to interpret the data. The research will provide lessons for the uptake and continuous use of innovations in the English and international health systems. Discussion Unlike most innovation studies, which involve

  12. Health status of and health-care provision to asylum seekers in Germany: protocol for a systematic review and evidence mapping of empirical studies.

    Science.gov (United States)

    Schneider, Christine; Mohsenpour, Amir; Joos, Stefanie; Bozorgmehr, Kayvan

    2014-11-29

    There are more than 100,000 asylum seekers registered in Germany, who are granted limited access to health services. This study aims to provide a systematic overview of the empirical literature on the health status of and health-care provision to asylum seekers in Germany in order to consolidate knowledge, avoid scientific redundance, and identify research gaps. A systematic review and evidence mapping of empirical literature on the health status of and health-care provision to asylum seekers in Germany will be performed. We will apply a three-tiered search strategy: 1. search in databases (PubMed/MEDLINE, Web of Science, IBSS, Sociological Abstracts, Worldwide Political Science Abstracts, CINAHL, Sowiport, Social Sciences Citation Index, ASSIA, MedPilot, DNB), dissertation and theses databases, and the internet (Google); 2. screening references of included studies; 3. contacting authors and civil society organizations for grey literature. Included will be studies which report quantitative and/or qualitative data or review articles on asylum seekers in Germany, published in German or English language. Outcome measures will include physical, mental, or social well-being, and all aspects of health-care provision (access, availability, affordability, and quality). Search results will be screened for eligibility by screening titles, abstracts and full texts. Data extraction comprises information on study characteristics, research aims, and domains of health or health-care services analyzed. The quality of studies will be appraised and documented by appropriate assessment tools. A descriptive evidence map will be drawn by categorizing all included articles by research design and the health conditions and/or domains of health-care provision analyzed. The body of evidence will be evaluated, and a narrative evidence synthesis will be performed by means of a multi-level approach, whereby quantitative and qualitative evidence are analyzed as separate streams and the product

  13. Repeat prenatal corticosteroid prior to preterm birth: a systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: assessing the effects using the best level of evidence - study protocol

    Directory of Open Access Journals (Sweden)

    Crowther Caroline A

    2012-02-01

    Full Text Available Abstract Background The aim of this individual participant data (IPD meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol. Methods/Design The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant; severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4; chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia; use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support; and birth weight (Z-scores. For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean, cerebral palsy (abnormality of tone with motor dysfunction, blindness (for example, corrected visual acuity worse than 6/60 in the better eye or deafness (for example, hearing loss requiring amplification or worse. For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use

  14. Protocol for the Quick Clinical study: a randomised controlled trial to assess the impact of an online evidence retrieval system on decision-making in general practice

    Directory of Open Access Journals (Sweden)

    Kidd Michael R

    2006-08-01

    Full Text Available Abstract Background Online information retrieval systems have the potential to improve patient care but there are few comparative studies of the impact of online evidence on clinicians' decision-making behaviour in routine clinical work. Methods/design A randomized controlled parallel design is employed to assess the effectiveness of an online evidence retrieval system, Quick Clinical (QC in improving clinical decision-making processes in general practice. Eligible clinicians are randomised either to receive access or not to receive access to QC in their consulting rooms for 12 months. Participants complete pre- and post trial surveys. Two-hundred general practitioners are recruited. Participants must be registered to practice in Australia, have a computer with Internet access in their consulting room and use electronic prescribing. Clinicians planning to retire or move to another practice within 12 months or participating in any other clinical trial involving electronic extraction of prescriptions data are excluded from the study. The primary end-points for the study is clinician acceptance and use of QC and the resulting change in decision-making behaviour. The study will examine prescribing patterns related to frequently prescribed medications where there has been a recent significant shift in recommendations regarding their use based upon new evidence. Secondary outcome measures include self-reported changes in diagnosis, patient education, prescriptions written, investigations and referrals. Discussion A trial under experimental conditions is an effective way of examining the impact of using QC in routine general practice consultations.

  15. Managing symptoms during cancer treatments: evaluating the implementation of evidence-informed remote support protocols

    Directory of Open Access Journals (Sweden)

    Stacey Dawn

    2012-11-01

    Full Text Available Abstract Background Management of cancer treatment-related symptoms is an important safety issue given that symptoms can become life-threatening and often occur when patients are at home. With funding from the Canadian Partnership Against Cancer, a pan-Canadian steering committee was established with representation from eight provinces to develop symptom protocols using a rigorous methodology (CAN-IMPLEMENT©. Each protocol is based on a systematic review of the literature to identify relevant clinical practice guidelines. Protocols were validated by cancer nurses from across Canada. The aim of this study is to build an effective and sustainable approach for implementing evidence-informed protocols for nurses to use when providing remote symptom assessment, triage, and guidance in self-management for patients experiencing symptoms while undergoing cancer treatments. Methods A prospective mixed-methods study design will be used. Guided by the Knowledge to Action Framework, the study will involve (a establishing an advisory knowledge user team in each of three targeted settings; (b assessing factors influencing nurses’ use of protocols using interviews/focus groups and a standardized survey instrument; (c adapting protocols for local use, ensuring fidelity of the content; (d selecting intervention strategies to overcome known barriers and implementing the protocols; (e conducting think-aloud usability testing; (f evaluating protocol use and outcomes by conducting an audit of 100 randomly selected charts at each of the three settings; and (g assessing satisfaction with remote support using symptom protocols and change in nurses’ barriers to use using survey instruments. The primary outcome is sustained use of the protocols, defined as use in 75% of the calls. Descriptive analysis will be conducted for the barriers, use of protocols, and chart audit outcomes. Content analysis will be conducted on interviews/focus groups and usability testing

  16. Clinician-led improvement in cancer care (CLICC) - testing a multifaceted implementation strategy to increase evidence-based prostate cancer care: phased randomised controlled trial - study protocol

    Science.gov (United States)

    2014-01-01

    Background Clinical practice guidelines have been widely developed and disseminated with the aim of improving healthcare processes and patient outcomes but the uptake of evidence-based practice remains haphazard. There is a need to develop effective implementation methods to achieve large-scale adoption of proven innovations and recommended care. Clinical networks are increasingly being viewed as a vehicle through which evidence-based care can be embedded into healthcare systems using a collegial approach to agree on and implement a range of strategies within hospitals. In Australia, the provision of evidence-based care for men with prostate cancer has been identified as a high priority. Clinical audits have shown that fewer than 10% of patients in New South Wales (NSW) Australia at high risk of recurrence after radical prostatectomy receive guideline recommended radiation treatment following surgery. This trial will test a clinical network-based intervention to improve uptake of guideline recommended care for men with high-risk prostate cancer. Methods/Design In Phase I, a phased randomised cluster trial will test a multifaceted intervention that harnesses the NSW Agency for Clinical Innovation (ACI) Urology Clinical Network to increase evidence-based care for men with high-risk prostate cancer following surgery. The intervention will be introduced in nine NSW hospitals over 10 months using a stepped wedge design. Outcome data (referral to radiation oncology for discussion of adjuvant radiotherapy in line with guideline recommended care or referral to a clinical trial of adjuvant versus salvage radiotherapy) will be collected through review of patient medical records. In Phase II, mixed methods will be used to identify mechanisms of provider and organisational change. Clinicians’ knowledge and attitudes will be assessed through surveys. Process outcome measures will be assessed through document review. Semi-structured interviews will be conducted to elucidate

  17. Implementing an evidence-based computerized decision support system to improve patient care in a general hospital: the CODES study protocol for a randomized controlled trial.

    Science.gov (United States)

    Moja, Lorenzo; Polo Friz, Hernan; Capobussi, Matteo; Kwag, Koren; Banzi, Rita; Ruggiero, Francesca; González-Lorenzo, Marien; Liberati, Elisa Giulia; Mangia, Massimo; Nyberg, Peter; Kunnamo, Ilkka; Cimminiello, Claudio; Vighi, Giuseppe; Grimshaw, Jeremy; Bonovas, Stefanos

    2016-07-07

    Computerized decision support systems (CDSSs) are information technology-based software that provide health professionals with actionable, patient-specific recommendations or guidelines for disease diagnosis, treatment, and management at the point-of-care. These messages are intelligently filtered to enhance the health and clinical care of patients. CDSSs may be integrated with patient electronic health records (EHRs) and evidence-based knowledge. We designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, evidence-based reminders generated at the point-of-care by a multi-specialty decision support system on clinical practice and the quality of care. We will include all the patients admitted to the internal medicine department of one large general hospital. The primary outcome is the rate at which medical problems, which are detected by the decision support software and reported through the reminders, are resolved (i.e., resolution rates). Secondary outcomes are resolution rates for reminders specific to venous thromboembolism (VTE) prevention, in-hospital all causes and VTE-related mortality, and the length of hospital stay during the study period. The adoption of CDSSs is likely to increase across healthcare systems due to growing concerns about the quality of medical care and discrepancy between real and ideal practice, continuous demands for a meaningful use of health information technology, and the increasing use of and familiarity with advanced technology among new generations of physicians. The results of our study will contribute to the current understanding of the effectiveness of CDSSs in primary care and hospital settings, thereby informing future research and healthcare policy questions related to the feasibility and value of CDSS use in healthcare systems. This trial is seconded by a specialty trial randomizing patients in an oncology setting (ONCO-CODES). ClinicalTrials.gov, https://clinicaltrials.gov/ct2

  18. Implementing and up-scaling evidence-based eMental health in Europe: The study protocol for the MasterMind project

    NARCIS (Netherlands)

    Vis, P.D.C.; Kleiboer, A.M.; Prior, R.; Bønes, E.; Cavallo, M.; Clark, S.A.; Dozeman, E.; Ebert, D.D.; Etzelmueller, A.; Favaretto, G.; Zabala, A.F.; Kolstrup, N.; Mancin, S.; Mathiasen, K.; Myrbakk, V.N.; Mol, M.; Jimenez, J.P.; Power, K.; van Schaik, A.; Wright, C.; Zanaldo, E.; Pederson, C.D.; Smit, J.H.; Riper, H.

    2015-01-01

    Background: Depressive disorder is a major societal challenge. Despite the availability of clinically and cost-effective treatments including Internet interventions, the number of patients receiving treatment is limited. Evidence-based Internet interventions promise wide availability and high

  19. Evidence-based new service package vs. routine service package for smoking cessation to prevent high risk patients from cardiovascular diseases (CVD): study protocol for randomized controlled trial.

    Science.gov (United States)

    Aung, Myo Nyein; Yuasa, Motoyuki; Lorga, Thaworn; Moolphate, Saiyud; Fukuda, Hiroshi; Kitajima, Tsutomu; Yokokawa, Hirohide; Minematsu, Kazuo; Tanimura, Susumu; Hiratsuka, Yoshimune; Ono, Koichi; Naunboonruang, Prissana; Thinuan, Payom; Kawai, Sachio; Suya, Yaoyanee; Chumvicharana, Somboon; Marui, Eiji

    2013-12-05

    Smoking cessation is a high-priority intervention to prevent CVD events and deaths in developing countries. While several interventions to stop smoking have been proved successful, the question of how to increase their effectiveness and practicality in developing countries remains. In this study, a newly devised evidence-based smoking cessation service package will be compared with the existing service in a randomized controlled trial within the community setting of Thailand. This randomized control trial will recruit 440 current smokers at CVD risk because of being diabetic and/or hypertensive. Informed, consented participants will be randomly allocated into the new service-package arm and the routine service arm. The study will take place in the non-communicable disease clinics of the Maetha District Hospital, Lampang, northern Thailand. The new smoking-cessation service-package comprises (1) regular patient motivation and coaching from the same primary care nurse over a 3-month period; (2) monthly application of piCO + smokerlyzer to sustain motivation of smoker's quitting attempt and provide positive feedback over a 3-month period; (3) assistance by an assigned family member; (4) nicotine replacement chewing gum to relieve withdrawal symptoms. This new service will be compared with the traditional routine service comprising the 5A approach in a 1-year follow-up. Participants who consent to participate in the study but refuse to attempt quitting smoking will be allocated to the non-randomized arm, where they will be just followed up and monitored. Primary outcome of the study is smoking cessation rate at 1-year follow-up proven by breath analysis measuring carbomonoxide in parts per million in expired air. Secondary outcomes are smoking cessation rate at the 6-month follow-up, blood pressure and heart rate, CVD risk according to the Framingham general cardiovascular risk score, CVD events and deaths at the 12-month follow-up, and the cost-effectiveness of the

  20. Implementing and up-scaling evidence-based eMental health in Europe: The study protocol for the MasterMind project

    Directory of Open Access Journals (Sweden)

    Christiaan Vis

    2015-11-01

    Discussion: The use of Internet interventions in routine practice is limited. MasterMind attempts to bridge the gap between routine practice and effectiveness research by evaluating the implementation of evidence-based Internet interventions for depressive disorders in routine mental healthcare settings in Europe.

  1. Evidence: Study Guide. Revision

    National Research Council Canada - National Science Library

    1997-01-01

    ...) correct application of principles of military rules of evidence. This study guide is also intended to be a convenient reference for use by Navy and Marine Corps judge advocates and Coast Guard law...

  2. A cluster randomized trial to improve adherence to evidence-based guidelines on diabetes and reduce clinical inertia in primary care physicians in Belgium: study protocol [NTR 1369].

    NARCIS (Netherlands)

    Borgermans, L.D.A.; Goderis, G.; Broeke, C.V.; Mathieu, C.; Aertgeerts, B.; Verbeke, G.; Carbonez, A.; Ivanova, A.; Grol, R.P.T.M.; Heyrman, J.

    2008-01-01

    ABSTRACT: BACKGROUND: Most quality improvement programs in diabetes care incorporate aspects of clinician education, performance feedback, patient education, care management, and diabetes care teams to support primary care physicians. Few studies have applied all of these dimensions to address

  3. NEURAPRO-E study protocol

    DEFF Research Database (Denmark)

    Markulev, Connie; McGorry, Patrick D; Nelson, Barnaby

    2017-01-01

    polyunsaturated fatty acids (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) samples, mean that further study of such benign, potentially neuroprotective interventions is clinically and ethically required. Employing a multicentre approach, enabling a large sample size, this study......AIM: Recent research has indicated that preventative intervention is likely to benefit patients 'at-risk' for psychosis, both in terms of symptom reduction and delay or prevention of onset of threshold psychotic disorder. The strong preliminary results for the effectiveness of omega-3...... omega-3 PUFAs plus cognitive-behavioural case management (CBCM) will be less likely to transition to psychosis over a 6-month period compared to treatment with placebo plus CBCM. Secondary outcomes will examine symptomatic and functional changes, as well as examine if candidate risk factors predict...

  4. Physical exercise, fitness and dietary pattern and their relationship with circadian blood pressure pattern, augmentation index and endothelial dysfunction biological markers: EVIDENT study protocol

    Directory of Open Access Journals (Sweden)

    Nicolás Eguskiñe

    2010-05-01

    Full Text Available Abstract Background Healthy lifestyles may help to delay arterial aging. The purpose of this study is to analyze the relationship of physical activity and dietary pattern to the circadian pattern of blood pressure, central and peripheral blood pressure, pulse wave velocity, carotid intima-media thickness and biological markers of endothelial dysfunction in active and sedentary individuals without arteriosclerotic disease. Methods/Design Design: A cross-sectional multicenter study with six research groups. Subjects: From subjects of the PEPAF project cohort, in which 1,163 who were sedentary became active, 1,942 were sedentary and 2,346 were active. By stratified random sampling, 1,500 subjects will be included, 250 in each group. Primary measurements: We will evaluate height, weight, abdominal circumference, clinical and ambulatory blood pressure with the Radial Pulse Wave Acquisition Device (BPro, central blood pressure and augmentation index with Pulse Wave Application Software (A-Pulse and SphymgoCor System Px (Pulse Wave Analysis, pulse wave velocity (PWV with SphymgoCor System Px (Pulse Wave Velocity, nutritional pattern with a food intake frequency questionnaire, physical activity with the 7-day PAR questionnaire and accelerometer (Actigraph GT3X, physical fitness with the cycle ergometer (PWC-170, carotid intima-media thickness by ultrasound (Micromax, and endothelial dysfunction biological markers (endoglin and osteoprotegerin. Discussion Determining that sustained physical activity and the change from sedentary to active as well as a healthy diet improve circadian pattern, arterial elasticity and carotid intima-media thickness may help to propose lifestyle intervention programs. These interventions could improve the cardiovascular risk profile in some parameters not routinely assessed with traditional risk scales. From the results of this study, interventional approaches could be obtained to delay vascular aging that combine physical

  5. Using mobile health technology to improve behavioral skill implementation through homework in evidence-based parenting intervention for disruptive behavior disorders in youth: study protocol for intervention development and evaluation.

    Science.gov (United States)

    Chacko, Anil; Isham, Andrew; Cleek, Andrew F; McKay, Mary M

    2016-01-01

    Disruptive behavior disorders (DBDs) (oppositional defiant disorder (ODD) and conduct disorder (CD)) are prevalent, costly, and oftentimes chronic psychiatric disorders of childhood. Evidence-based interventions that focus on assisting parents to utilize effective skills to modify children's problematic behaviors are first-line interventions for the treatment of DBDs. Although efficacious, the effects of these interventions are often attenuated by poor implementation of the skills learned during treatment by parents, often referred to as between-session homework. The multiple family group (MFG) model is an evidence-based, skills-based intervention model for the treatment of DBDs in school-age youth residing in urban, socio-economically disadvantaged communities. While data suggest benefits of MFG on DBD behaviors, similar to other skill-based interventions, the effects of MFG are mitigated by the poor homework implementation, despite considerable efforts to support parents in homework implementation. This paper focuses on the study protocol for the development and preliminary evaluation of a theory-based, smartphone mobile health (mHealth) application (My MFG) to support homework implementation by parents participating in MFG. This paper describes a study design proposal that begins with a theoretical model, uses iterative design processes to develop My MFG to support homework implementation in MFG through a series of pilot studies, and a small-scale pilot randomised controlled trial to determine if the intervention can demonstrate change (preliminary efficacy) of My MFG in outpatient mental health settings in socioeconomically disadvantaged communities. This preliminary study aims to understand the implementation of mHealth methods to improve the effectiveness of evidence-based interventions in routine outpatient mental health care settings for youth with disruptive behavior and their families. Developing methods to augment the benefits of evidence

  6. Implementation of an Evidence-Based Protocol for Surgical Infection Prophylaxis

    National Research Council Canada - National Science Library

    Savino, John A; Smeland, Jane; Flink, Ellen L; Ruperto, Angelo; Hines, Amanda; Sullivan, Thomas; Galvin, Kerri; Risucci, Donald A

    2005-01-01

    An evidence-based surgical antimicrobial prophylaxis (AMP) protocol was implemented in multiple facilities to determine if compliance led to a decrease in New York State reportable surgical site infections (SSIs...

  7. Quality of life and myelomeningocele: an ethical and evidence-based analysis of the Groningen Protocol.

    Science.gov (United States)

    Barry, Sean

    2010-01-01

    In 2005, a group of pediatricians at the University Medical Center in Groningen, The Netherlands, published the Groningen Protocol (GP) for Euthanasia in Newborns. This protocol is a set of guidelines devised in 2001 to clarify and facilitate the assessment of clinically stable neonates deemed to be in unbearable suffering for whom the prognosis is felt to be hopeless. At the time of publication, the GP had been in use for 7 years, and 22 patients, all with diagnosed myelomeningocele (MMC), had met the selection criteria for euthanasia by lethal injection. MMC is the most common neurological congenital anomaly, affecting approximately 300,000 newborns yearly worldwide. Neurosurgeons have a unique perspective on this disease and therefore an important voice, given the significant role they have in caring for these patients at all stages of their lives. This paper reviews the principal ethical arguments presented to date in the literature regarding the GP. It also provides an evidence-based critique of the GP in light of quality-of-life studies addressing adults with MMC, and ascertains whether or not the GP meets the criteria for an evidence-based guideline. Copyright © 2011 S. Karger AG, Basel.

  8. Interprofessional primary care protocols: a strategy to promote an evidence-based approach to teamwork and the delivery of care.

    Science.gov (United States)

    Goldman, Joanne; Meuser, Jamie; Lawrie, Lynne; Rogers, Jess; Reeves, Scott

    2010-11-01

    Primary care reform involving interprofessional team-based care is a global phenomenon. In Ontario, Canada, 150 Family Health Teams (FHTs) have been approved in the past few years. The transition to a FHT is complex involving many changes and the processes for collaborative teamwork are not clearly delineated. To support the transition to team-based care in FHTs, a project was undertaken to develop and implement a series of interprofessional protocols in four clinical areas. These interprofessional protocols would contain relevant and evidence-based resources to support both a team and evidence-based approach to care. This paper reports on a qualitative study to examine the process of interprofessional protocol development and pilot implementation. Adopting an exploratory case study approach (Robson, 2002 ), 36 interviews were conducted with health professionals and community group members who participated in the creation and piloting of the protocols, and with project managers. In addition, observational and documentary data were gathered on the protocol development and implementation processes. The findings from the protocol development stage demonstrate the value of the focus on evidence and team, the process of assessing and targeting FHT needs, inter-organizational and interprofessional sharing, the importance of facilitation and support, and expectations for implementation. The findings from the pilot implementation stage report on the importance of champions and leaders, the implementation strategies used, FHT and organizational factors affecting implementation, and outcomes achieved. Findings are discussed in relation to the knowledge translation and interprofessional literature. Research is ongoing to examine the effectiveness of dissemination of the protocols to FHTs across the province of Ontario and its impact on health care outcomes.

  9. Individualized music for dementia: Evolution and application of evidence-based protocol.

    Science.gov (United States)

    Gerdner, Linda A

    2012-04-22

    The theory-based intervention of individualized music has been evaluated clinically and empirically leading to advancement and refinement of an evidence-based protocol, currently in its 5th edition. An expanded version of the protocol was written for professional health care providers with a consumer version tailored for family caregivers. The underlying mid-range theory is presented along with a seminal study that was followed by further research in the United States, Canada, Great Britain, France, Sweden, Norway, Japan and Taiwan. Key studies are summarized. Given its efficacy when implemented by research staff, studies have advanced to testing the intervention under real-life conditions when implemented and evaluated by trained nursing assistants in long-term care facilities and visiting family members. In addition, one study evaluated the implementation of music by family members in the home setting. Initial research focused on agitation as the dependent variable with subsequent research indicating a more holistic response such as positive affect, expressed satisfaction, and meaningful interaction with others. The article advances by describing on-line programs designed to train health care professionals in the assessment, implementation and evaluation of individualized music. In addition, Gerdner has written a story for a picture book intended for children and their families (in press). The story models principles of individualized music to elicit positive memories, reduce anxiety and agitation, and promote communication. The article concludes with implications for future research.

  10. 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 quantify relationships in data. Despite an increased focus on statistical content and complexity of biomedical research these topics remain difficult for most researchers. Statistical methods enable researchers to condense large spreadsheets with data into means, proportions, and difference between means...... the statistical principles for trial protocols in terms of design, analysis, and reporting of findings....

  11. Prayer Healing: A Case Study Research Protocol.

    Science.gov (United States)

    Kruijthoff, Dirk J; van der Kooi, Cornelis; Glas, Gerrit; Abma, Tineke A

    2017-01-01

    Context • Prayer healing is a common practice in many religious communities around the world. Even in the highly secularized Dutch society, cases of prayer healing are occasionally reported in the media, often generating public attention. There is an ongoing debate regarding whether such miraculous cures do actually occur and how to interpret them. Objective • The aim of the article was to present a research protocol for the investigation of reported cases of remarkable and/or unexplained healing after prayer. Design • The research team developed a method to perform a retrospective, case-based study of prayer healing. Reported prayer healings can be investigated systematically in accordance with a step-by-step methodology. The focus is on understanding the healing by studying it from multiple perspectives, using both medical judgment and patients' narratives collected by qualitative methods Setting • The study occurred at Vrije Universiteit (VU) and VU Medical Center (Amsterdam, Netherlands) as well as the general medical practice of the first author. Participants • Potential participants could be any individuals in the Netherlands or neighboring countries who claim to have been healed through prayer. The reports of healing came from multiple sources, including the research team's medical practices and their direct vicinities, newspaper articles, prayer healers, and medical colleagues. Outcome Measures • Medical data were obtained before and after prayer. Subsequently, a member of a research team and of a medical assessment committee made a standardized judgment that evaluated whether a cure was clinically remarkable or scientifically unexplained. The participants' experiences and insider perspectives were studied, using in-depth interviews in accordance with a qualitative research methodology, to gain insight into the perceptions and explanations of the cures that were offered by participants and by the members of the medical assessment committee. The

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

    International Nuclear Information System (INIS)

    Arshad, J.; Akram, Q.; Saleem, Y.

    2014-01-01

    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)

  13. 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.

  14. 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.

  15. The influence of referral protocols on the utilization of magnetic resonance imaging: evidence from Manitoba

    Energy Technology Data Exchange (ETDEWEB)

    Mustard, C.A.; McClarty, B.M.; MacEwan, D.W. [Manitoba Univ., Winnipeg, MB (Canada)

    1994-04-01

    The influence of referral protocols on the utilization of magnetic resonance imaging (MRI) services was studied. Three neuroradiologists and one radiologist reviewed the indications for MRI for 198 referrals to a facility in Winnipeg, selected at random from patients seen in 1991 for suspected disorders of the brain or the spine. Out-of-province referrals had not been subject to referral protocols, whereas those from within Manitoba had been subject to such protocols. At least three of the four radiologists agreed on whether an examination was appropriate in 88.4 % of the cases. Out-of-province referrals were significantly more likely to be considered inappropriate for MRI (24 %) than referrals from within Manitoba (10 %). It was estimated that the combined effect of instituting protocols and reviewing each referral before the examination could result in a 16 % to 31 % reduction in the demand for MRI services without compromising diagnostic information. 18 refs., 3 tabs.

  16. Group differences in physician responses to handheld presentation of clinical evidence: a verbal protocol analysis

    Directory of Open Access Journals (Sweden)

    Pavlovic Nada J

    2007-07-01

    Full Text Available Abstract Background To identify individual differences in physicians' needs for the presentation of evidence resources and preferences for mobile devices. Methods Within-groups analysis of responses to semi-structured interviews. Interviews consisted of using prototypes in response to task-based scenarios. The prototypes were implemented on two different form factors: a tablet style PC and a pocketPC. Participants were from three user groups: general internists, family physicians and medicine residents, and from two different settings: urban and semi-urban. Verbal protocol analysis, which consists of coding utterances, was conducted on the transcripts of the testing sessions. Statistical relationships were investigated between staff physicians' and residents' background variables, self-reported experiences with the interfaces, and verbal code frequencies. Results 47 physicians were recruited from general internal medicine, family practice clinics and a residency training program. The mean age of participants was 42.6 years. Physician specialty had a greater effect on device and information-presentation preferences than gender, age, setting or previous technical experience. Family physicians preferred the screen size of the tablet computer and were less concerned about its portability. Residents liked the screen size of the tablet, but preferred the portability of the pocketPC. Internists liked the portability of the pocketPC, but saw less advantage to the large screen of the tablet computer (F[2,44] = 4.94, p = .012. Conclusion Different types of physicians have different needs and preferences for evidence-based resources and handheld devices. This study shows how user testing can be incorporated into the process of design to inform group-based customization.

  17. Optimizing the high-resolution manometry (HRM) study protocol.

    Science.gov (United States)

    Patel, A; Ding, A; Mirza, F; Gyawali, C P

    2015-02-01

    Intolerance of the esophageal manometry catheter may prolong high-resolution manometry (HRM) studies and increase patient distress. We assessed the impact of obtaining the landmark phase at the end of the study when the patient has acclimatized to the HRM catheter. 366 patients (mean age 55.4 ± 0.8 years, 62.0% female) undergoing esophageal HRM over a 1-year period were studied. The standard protocol consisted of the landmark phase, 10 5 mL water swallows 20-30 s apart, and multiple rapid swallows where 4-6 2 mL swallows were administered in rapid succession. The modified protocol consisted of the landmark phase at the end of the study after test swallows. Study duration, technical characteristics, indications, and motor findings were compared between standard and modified protocols. Of the 366 patients, 89.6% underwent the standard protocol (study duration 12.9 ± 0.3 min). In 10.4% with poor catheter tolerance undergoing the modified protocol, study duration was significantly longer (15.6 ± 1.0 min, p = 0.004) despite similar duration of study maneuvers. Only elevated upper esophageal sphincter basal pressures at the beginning of the study segregated modified protocol patients. The 95th percentile time to landmark phase in the standard protocol patients was 6.1 min; as many as 31.4% of modified protocol patients could not obtain their first study maneuver within this period (p = 0.0003). Interpretation was not impacted by shifting the landmark phase to the end of the study. Modification of the HRM study protocol with the landmark phase obtained at the end of the study optimizes study duration without compromising quality. © 2014 John Wiley & Sons Ltd.

  18. Extraction protocols for orthodontic treatment: A retrospective study

    Directory of Open Access Journals (Sweden)

    Vaishnevi N Thirunavukkarasu

    2016-01-01

    Full Text Available 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.

  19. Study protocol for a systematic review of evidence for lifestyle interventions targeting smoking, sleep, alcohol/other drug use, physical activity, and healthy diet in people with bipolar disorder.

    Science.gov (United States)

    Kay-Lambkin, Frances J; Thornton, Louise; Lappin, Julia M; Hanstock, Tanya; Sylvia, Louisa; Jacka, Felice; Baker, Amanda L; Berk, Michal; Mitchell, Phillip B; Callister, Robin; Rogers, Naomi; Webster, Stephanie; Dennis, Simon; Oldmeadow, Christopher; MacKinnon, Andrew; Doran, Christopher; Turner, Alyna; Hunt, Sally

    2016-07-05

    People with bipolar disorder (BD) have a mortality gap of up to 20 years compared to the general population. Physical conditions, such as cardiovascular disease (CVD) and cancer, cause the majority of excess deaths in psychiatric populations and are the leading causes of mortality in people with BD. However, comparatively little attention has been paid to reducing the risk of physical conditions in psychiatric populations. Unhealthy lifestyle behaviors are among the potentially modifiable risk factors for a range of commonly comorbid chronic medical conditions, including CVD, diabetes, and obesity. This systematic review will identify and evaluate the available evidence for effective interventions to reduce risk and promote healthy lifestyle behaviors in BD. We will search MEDLINE, Embase, PsychINFO, Cochrane Database of Systematic Reviews, and CINAHL for published research studies (with at least an abstract published in English) that evaluate behavioral or psychosocial interventions to address the following lifestyle factors in people with BD: tobacco use, physical inactivity, unhealthy diet, overweight or obesity, sleep-wake disturbance, and alcohol/other drug use. Primary outcomes for the review will be changes in tobacco use, level of physical activity, diet quality, sleep quality, alcohol use, and illicit drug use. Data on each primary outcome will be synthesized across available studies in that lifestyle area (e.g., tobacco abstinence, cigarettes smoked per day), and panel of research and clinical experts in each of the target lifestyle behaviors and those experienced with clinical and research with individuals with BD will determine how best to represent data related to that primary outcome. Seven members of the systematic review team will extract data, synthesize the evidence, and rate it for quality. Evidence will be synthesized via a narrative description of the behavioral interventions and their effectiveness in improving the healthy lifestyle behaviors

  20. An evidence based protocol for peer review of radiographer musculoskeletal plain film reporting

    International Nuclear Information System (INIS)

    Stephenson, Paul; Hannah, April; Jones, Helen; Edwards, Rosemary; Harrington, Kate; Baker, Sally-Anne; Fitzgerald, Nicole; Belfield, Jane

    2012-01-01

    Aims: Medical image interpretation by non-medically trained staff continues to court controversy. This article aims to show that any potential risks associated with radiographer reporting can be monitored and mitigated if a robust peer review system is introduced. A search of the evidence base illustrates a paucity of guidance on how reporting radiographers should be audited or how a peer review process should be implemented. A practical framework for designing a reporting radiographer peer review process is provided. Methods: Following a literature review, key issues faced when designing a peer review protocol were identified. The following questions are answered: How frequent should peer review take place? How many reports should be reviewed? How are reports selected for review? Who should peer review the radiographer reports? How should radiographer's reporting performance be measured? What standard of reporting is acceptable? Results: Details are provided of the process that has been used for over three years at a busy inner-city teaching hospital for auditing musculoskeletal plain film radiographer reporting. The peer review method presented is not intended to produce robust statistical data; it is a practical method of locally assessing the reporting competency. As such, our protocol should be viewed as part of a larger programme for continuing professional development. Conclusion: It is hoped that this practical protocol will encourage radiology departments to engage in a programme of peer review for reporting radiographers.

  1. Quantitative methods for studying design protocols

    CERN Document Server

    Kan, Jeff WT

    2017-01-01

    This book is aimed at researchers and students who would like to engage in and deepen their understanding of design cognition research. The book presents new approaches for analyzing design thinking and proposes methods of measuring design processes. These methods seek to quantify design issues and design processes that are defined based on notions from the Function-Behavior-Structure (FBS) design ontology and from linkography. A linkograph is a network of linked design moves or segments. FBS ontology concepts have been used in both design theory and design thinking research and have yielded numerous results. Linkography is one of the most influential and elegant design cognition research methods. In this book Kan and Gero provide novel and state-of-the-art methods of analyzing design protocols that offer insights into design cognition by integrating segmentation with linkography by assigning FBS-based codes to design moves or segments and treating links as FBS transformation processes. They propose and test ...

  2. A Field-Based Testing Protocol for Assessing Gross Motor Skills in Preschool Children: The Children's Activity and Movement in Preschool Study Motor Skills Protocol

    Science.gov (United States)

    Williams, Harriet G.; Pfeiffer, Karin A.; Dowda, Marsha; Jeter, Chevy; Jones, Shaverra; Pate, Russell R.

    2009-01-01

    The purpose of this study was to develop a valid and reliable tool for use in assessing motor skills in preschool children in field-based settings. The development of the Children's Activity and Movement in Preschool Study Motor Skills Protocol included evidence of its reliability and validity for use in field-based environments as part of large…

  3. Factors that impact on the use of mechanical ventilation weaning protocols in critically ill adults and children: a qualitative evidence-synthesis.

    Science.gov (United States)

    Jordan, Joanne; Rose, Louise; Dainty, Katie N; Noyes, Jane; Blackwood, Bronagh

    2016-10-04

    Prolonged mechanical ventilation is associated with a longer intensive care unit (ICU) length of stay and higher mortality. Consequently, methods to improve ventilator weaning processes have been sought. Two recent Cochrane systematic reviews in ICU adult and paediatric populations concluded that protocols can be effective in reducing the duration of mechanical ventilation, but there was significant heterogeneity in study findings. Growing awareness of the benefits of understanding the contextual factors impacting on effectiveness has encouraged the integration of qualitative evidence syntheses with effectiveness reviews, which has delivered important insights into the reasons underpinning (differential) effectiveness of healthcare interventions. 1. To locate, appraise and synthesize qualitative evidence concerning the barriers and facilitators of the use of protocols for weaning critically-ill adults and children from mechanical ventilation;2. To integrate this synthesis with two Cochrane effectiveness reviews of protocolized weaning to help explain observed heterogeneity by identifying contextual factors that impact on the use of protocols for weaning critically-ill adults and children from mechanical ventilation;3. To use the integrated body of evidence to suggest the circumstances in which weaning protocols are most likely to be used. We used a range of search terms identified with the help of the SPICE (Setting, Perspective, Intervention, Comparison, Evaluation) mnemonic. Where available, we used appropriate methodological filters for specific databases. We searched the following databases: Ovid MEDLINE, Embase, OVID, PsycINFO, CINAHL Plus, EBSCOHost, Web of Science Core Collection, ASSIA, IBSS, Sociological Abstracts, ProQuest and LILACS on the 26th February 2015. In addition, we searched: the grey literature; the websites of professional associations for relevant publications; and the reference lists of all publications reviewed. We also contacted authors of

  4. The EADC-ADNI Harmonized Protocol for manual hippocampal segmentation on magnetic resonance: Evidence of validity

    Science.gov (United States)

    Frisoni, Giovanni B.; Jack, Clifford R.; Bocchetta, Martina; Bauer, Corinna; Frederiksen, Kristian S.; Liu, Yawu; Preboske, Gregory; Swihart, Tim; Blair, Melanie; Cavedo, Enrica; Grothe, Michel J.; Lanfredi, Mariangela; Martinez, Oliver; Nishikawa, Masami; Portegies, Marileen; Stoub, Travis; Ward, Chadwich; Apostolova, Liana G.; Ganzola, Rossana; Wolf, Dominik; Barkhof, Frederik; Bartzokis, George; DeCarli, Charles; Csernansky, John G.; deToledo-Morrell, Leyla; Geerlings, Mirjam I.; Kaye, Jeffrey; Killiany, Ronald J.; Lehéricy, Stephane; Matsuda, Hiroshi; O'Brien, John; Silbert, Lisa C.; Scheltens, Philip; Soininen, Hilkka; Teipel, Stefan; Waldemar, Gunhild; Fellgiebel, Andreas; Barnes, Josephine; Firbank, Michael; Gerritsen, Lotte; Henneman, Wouter; Malykhin, Nikolai; Pruessner, Jens C.; Wang, Lei; Watson, Craig; Wolf, Henrike; deLeon, Mony; Pantel, Johannes; Ferrari, Clarissa; Bosco, Paolo; Pasqualetti, Patrizio; Duchesne, Simon; Duvernoy, Henri; Boccardi, Marina

    2015-01-01

    Background An international Delphi panel has defined a harmonized protocol (HarP) for the manual segmentation of the hippocampus on MR. The aim of this study is to study the concurrent validity of the HarP toward local protocols, and its major sources of variance. Methods Fourteen tracers segmented 10 Alzheimer's Disease Neuroimaging Initiative (ADNI) cases scanned at 1.5 T and 3T following local protocols, qualified for segmentation based on the HarP through a standard web-platform and resegmented following the HarP. The five most accurate tracers followed the HarP to segment 15 ADNI cases acquired at three time points on both 1.5 T and 3T. Results The agreement among tracers was relatively low with the local protocols (absolute left/right ICC 0.44/0.43) and much higher with the HarP (absolute left/right ICC 0.88/0.89). On the larger set of 15 cases, the HarP agreement within (left/right ICC range: 0.94/0.95 to 0.99/0.99) and among tracers (left/right ICC range: 0.89/0.90) was very high. The volume variance due to different tracers was 0.9% of the total, comparing favorably to variance due to scanner manufacturer (1.2), atrophy rates (3.5), hemispheric asymmetry (3.7), field strength (4.4), and significantly smaller than the variance due to atrophy (33.5%, P < .001), and physiological variability (49.2%, P < .001). Conclusions The HarP has high measurement stability compared with local segmentation protocols, and good reproducibility within and among human tracers. Hippocampi segmented with the HarP can be used as a reference for the qualification of human tracers and automated segmentation algorithms. PMID:25267715

  5. Identification of a research protocol to study orthodontic tooth movement

    Directory of Open Access Journals (Sweden)

    Annalisa Dichicco

    2014-06-01

    Full Text Available Aim: The orthodontic movement is associated with a process of tissue remodeling together with the release of several chemical mediators in periodontal tissues. Each mediator is a potential marker of tooth movement and expresses biological processes as: tissue inflammation and bone remodeling. Different amounts of every mediator are present in several tissues and fluids of the oral cavity. Therefore, there are different methods that allow sampling with several degrees of invasiveness. Chemical mediators are also substances of different molecular nature, and multiple kind of analysis methods allow detection. The purpose of this study was to draft the best research protocol for an optimal study on orthodontic movement efficiency. Methods: An analysis of the international literature have been made, to identify the gold standard of each aspect of the protocol: type of mediator, source and method of sampling and analysis method. Results: From the analysis of the international literature was created an original research protocol for the study and the assessment of the orthodontic movement, by using the biomarkers of the tooth movement. Conclusions: The protocol created is based on the choice of the gold standard of every aspect already analyzed in the literature and in existing protocols for the monitoring of orthodontic tooth movement through the markers of tooth movement. Clinical trials re required for the evaluation and validation of the protocol created.

  6. Barriers and enablers in primary care clinicians' management of osteoarthritis: protocol for a systematic review and qualitative evidence synthesis.

    Science.gov (United States)

    Egerton, T; Diamond, L; Buchbinder, R; Bennell, K; Slade, S C

    2016-05-27

    Osteoarthritis is a highly prevalent and disabling condition. Primary care management of osteoarthritis is generally suboptimal despite evidence for several modestly effective interventions and the availability of high-quality clinical practice guidelines. This report describes a planned study to synthesise the views of primary care clinicians on the barriers and enablers to following recommended management of osteoarthritis, with the aim of providing new interpretations that may facilitate the uptake of recommended treatments, and in turn improve patient care. A systematic review and meta-synthesis of qualitative studies. 5 databases will be searched using key search terms for qualitative research, evidence-based practice, clinical practice guidelines, osteoarthritis, beliefs, perceptions, barriers, enablers and adherence. A priori inclusion/exclusion criteria include availability of data from primary care clinicians, reports on views regarding management of osteoarthritis, and studies using qualitative methods for both data collection and analysis. At least 2 independent reviewers will identify eligible reports, conduct a critical appraisal of study conduct, extract data and synthesise reported findings and interpretations. Synthesis will follow thematic analysis within a grounded theory framework of inductive coding and iterative theme identification. The reviewers plus co-authors will contribute to the meta-synthesis to find new themes and theories. The Confidence in the Evidence from Reviews of Qualitative research (CERQual) approach will be used to determine a confidence profile of each finding from the meta-synthesis. The protocol has been registered on PROSPERO and is reported using the Preferred Reporting Items for Systematic Review and Meta-Analyses Protocols (PRISMA-P) guidelines. Ethical approval is not required. The systematic review will be published in a peer-reviewed journal. The results will help to inform policy and practice and assist in the

  7. Addressing the evidence to practice gap for complex interventions in primary care: a systematic review of reviews protocol.

    Science.gov (United States)

    Lau, Rosa; Stevenson, Fiona; Ong, Bie Nio; Dziedzic, Krysia; Eldridge, Sandra; Everitt, Hazel; Kennedy, Anne; Kontopantelis, Evangelos; Little, Paul; Qureshi, Nadeem; Rogers, Anne; Treweek, Shaun; Peacock, Richard; Murray, Elizabeth

    2014-06-23

    Getting the results of research implemented into routine healthcare is often a challenge. The disconnect between the development and implementation of evidence into practice is called the 'second translational gap' and is particularly apparent in primary care. To address this gap, we plan to identify, summarise and synthesise currently available evidence by undertaking a systematic review of reviews to: (1) explore barriers and facilitators of implementation of research evidence or complex interventions, and (2) assess the effectiveness of strategies in facilitating implementation of complex interventions in primary care. This is a protocol for a systematic review of reviews. We will search MEDLINE, EMBASE, the Cochrane Library, CINAHL and PsycINFO up until December 2013. We will check reference lists of included studies for further studies. Two authors will independently screen the titles and abstracts identified from the search; any discrepancies will be resolved by discussion and consensus. Full-text papers will be obtained and relevant reviews will be selected against inclusion criteria. Eligible reviews have to be based on predominantly primary care in developed countries and examine either factors to implementation or, the effectiveness of strategies to optimise implementation. Data from eligible reviews will be extracted using standardised data abstraction forms. For barriers and facilitators, data will be synthesised using an interpretative meta-synthesis approach. For implementation strategies, findings will be summarised and described narratively and synthesised using a framework approach. All findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Ethical approval is not required. The review findings will inform the work of the design and implementation of future studies and will be of interest to a wide audience including health professionals, researchers, health service or

  8. Combustion Safety Simplified Test Protocol Field Study

    Energy Technology Data Exchange (ETDEWEB)

    Brand, L [Gas Technology Inst., Des Plaines, IL (United States); Cautley, D. [Gas Technology Inst., Des Plaines, IL (United States); Bohac, D. [Gas Technology Inst., Des Plaines, IL (United States); Francisco, P. [Gas Technology Inst., Des Plaines, IL (United States); Shen, L. [Gas Technology Inst., Des Plaines, IL (United States); Gloss, S. [Gas Technology Inst., Des Plaines, IL (United States)

    2015-11-05

    "9Combustions safety is an important step in the process of upgrading homes for energy efficiency. There are several approaches used by field practitioners, but researchers have indicated that the test procedures in use are complex to implement and provide too many false positives. Field failures often mean that the house is not upgraded until after remediation or not at all, if not include in the program. In this report the PARR and NorthernSTAR DOE Building America Teams provide a simplified test procedure that is easier to implement and should produce fewer false positives. A survey of state weatherization agencies on combustion safety issues, details of a field data collection instrumentation package, summary of data collected over seven months, data analysis and results are included. The project provides several key results. State weatherization agencies do not generally track combustion safety failures, the data from those that do suggest that there is little actual evidence that combustion safety failures due to spillage from non-dryer exhaust are common and that only a very small number of homes are subject to the failures. The project team collected field data on 11 houses in 2015. Of these homes, two houses that demonstrated prolonged and excessive spillage were also the only two with venting systems out of compliance with the National Fuel Gas Code. The remaining homes experienced spillage that only occasionally extended beyond the first minute of operation. Combustion zone depressurization, outdoor temperature, and operation of individual fans all provide statistically significant predictors of spillage.

  9. Study and development of a remote biometric authentication protocol

    OpenAIRE

    Bistarelli, Stefano; Claudio, Viti

    2003-01-01

    This paper reports the phases of study and implementation of a remote biometric authentication protocol developed during my internship at the I.i.t. of the C.n.r. in Pisa. Starting from the study of authentication history we had a look from the first system used since the 60ies to the latest technology; this helped us understand how we could realize a demonstration working protocol that could achieve a web remote authentication granting good reliability: to do this we choosed to modify the SS...

  10. Study protocol for the Cities Changing Diabetes programme

    DEFF Research Database (Denmark)

    Napier, A David; Nolan, John J; Bagger, Malene

    2017-01-01

    and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through...... the Cities Changing Diabetes (CCD) partnership programme. METHODS AND ANALYSIS: A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan...... Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. ETHICS AND DISSEMINATION: The protocol steers the collection of primary and secondary data across the study sites. Research ethics...

  11. Continuous sawmill studies: protocols, practices, and profits

    Science.gov (United States)

    Robert Mayer; Jan Wiedenbeck

    2005-01-01

    In today's global economy, the "opportunity cost" associated with suboptimal utilization of raw material and mill resources is significant. As a result, understanding the profit potential associated with different types of logs is critically important for sawmill survival. The conventional sawmill study typically has been conducted on a substantially...

  12. Do evidence summaries increase policy-makers' use of evidence from systematic reviews: A systematic review protocol.

    Science.gov (United States)

    Petkovic, Jennifer; Welch, Vivian; Tugwell, Peter

    2015-09-28

    Systematic reviews are important for decision-makers. They offer many potential benefits but are often written in technical language, are too long, and do not contain contextual details which makes them hard to use for decision-making. There are many organizations that develop and disseminate derivative products, such as evidence summaries, from systematic reviews for different populations or subsets of decision-makers. This systematic review will assess the effectiveness of systematic review summaries on increasing policymakers' use of systematic review evidence and to identify the components or features of these summaries that are most effective. We will include studies of policy-makers at all levels as well as health-system managers. We will include studies examining any type of "evidence summary," "policy brief," or other products derived from systematic reviews that present evidence in a summarized form. The primary outcomes are the following: (1) use of systematic review summaries decision-making (e.g., self-reported use of the evidence in policy-making, decision-making) and (2) policy-maker understanding, knowledge, and/or beliefs (e.g., changes in knowledge scores about the topic included in the summary). We will conduct a systematic review of randomized controlled trials (RCTs), non-randomized controlled trials (NRCTs), controlled before-after studies (CBA), and interrupted time series (ITS) studies. The results of this review will inform the development of future systematic review summaries to ensure that systematic review evidence is accessible to and used by policy-makers making health-related decisions.

  13. Study on Cloud Security Based on Trust Spanning Tree Protocol

    Science.gov (United States)

    Lai, Yingxu; Liu, Zenghui; Pan, Qiuyue; Liu, Jing

    2015-09-01

    Attacks executed on Spanning Tree Protocol (STP) expose the weakness of link layer protocols and put the higher layers in jeopardy. Although the problems have been studied for many years and various solutions have been proposed, many security issues remain. To enhance the security and credibility of layer-2 network, we propose a trust-based spanning tree protocol aiming at achieving a higher credibility of LAN switch with a simple and lightweight authentication mechanism. If correctly implemented in each trusted switch, the authentication of trust-based STP can guarantee the credibility of topology information that is announced to other switch in the LAN. To verify the enforcement of the trusted protocol, we present a new trust evaluation method of the STP using a specification-based state model. We implement a prototype of trust-based STP to investigate its practicality. Experiment shows that the trusted protocol can achieve security goals and effectively avoid STP attacks with a lower computation overhead and good convergence performance.

  14. Using mobile health technology to improve behavioral skill implementation through homework in evidence-based parenting intervention for disruptive behavior disorders in youth: study protocol for intervention development and evaluation

    OpenAIRE

    Chacko, Anil; Isham, Andrew; Cleek, Andrew F.; McKay, Mary M.

    2016-01-01

    Background Disruptive behavior disorders (DBDs) (oppositional defiant disorder (ODD) and conduct disorder (CD)) are prevalent, costly, and oftentimes chronic psychiatric disorders of childhood. Evidence-based interventions that focus on assisting parents to utilize effective skills to modify children?s problematic behaviors are first-line interventions for the treatment of DBDs. Although efficacious, the effects of these interventions are often attenuated by poor implementation of the skills ...

  15. 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 quantify relationships in data. Despite an increased focus on statistical content and complexity of biomedical research these topics remain difficult for most researchers. Statistical methods enable researchers to condense large spreadsheets with data into means, proportions, and difference between means......, risk differences, and other quantities that convey information. One of the goals in biomedical research is to develop parsimonious models - meaning as simple as possible. This approach is valid if the subsequent research report (the article) is written independent of whether the results...

  16. A parathyroid adenoma case study: Protocol review

    International Nuclear Information System (INIS)

    Sorensen, B.J.; Chu, J.M.G.

    1998-01-01

    Full text: Technetium-99m ( 99m Tc) Sestamibi as opposed to Thallous-201 Chloride and 99m Tc 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 99m Tc 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 99m Tc 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 99m Tc Sodium Pertechnetate and scanned with a pinhole collimator at a distance of 7 cm. When the 99m Tc Sestamibi and 99m Tc Sodium Pertechnetate scan were viewed together, it was clear that there was excess 99m Tc 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 99m Tc Sodium Pertechnetate scan and an ultrasound are now also routinely performed on patients presenting for 99m Tc Sestamibi parathyroid scans

  17. A parathyroid adenoma case study: Protocol review

    Energy Technology Data Exchange (ETDEWEB)

    Sorensen, B.J.; Chu, J.M.G. [Liverpool Hospital, NSW (Australia). Department of Nuclear Medicine and Clinical Ultrasound

    1998-06-01

    Full text: Technetium-99m ({sup 99m}Tc) Sestamibi as opposed to Thallous-201 Chloride and {sup 99m}Tc 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 {sup 99m}Tc 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 {sup 99m}Tc 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 {sup 99m}Tc Sodium Pertechnetate and scanned with a pinhole collimator at a distance of 7 cm. When the {sup 99m}Tc Sestamibi and {sup 99m}Tc Sodium Pertechnetate scan were viewed together, it was clear that there was excess {sup 99m}Tc 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 {sup 99m}Tc Sodium Pertechnetate scan and an ultrasound are now also routinely performed on patients presenting for {sup 99m}Tc Sestamibi parathyroid scans

  18. Epidemiological characterization of oral cancer. Study Protocol.

    Directory of Open Access Journals (Sweden)

    Alejandra Fernández

    2015-04-01

    Full Text Available Oral cancer is a disease of high impact globally. It ranks as the sixth more frequent one among all types of cancer. In spite of being a widely known pathology and easy access to the diagnosis, the lack of epidemiological data reported in the last 10 years in Chile called attention to. At the global level, the World Health Organization (WHO has developed a project called “GLOBOCAN” in order to collect epidemiological data of the global cancer, between its data, highlights the high incidence and high rate of mortality in the male sex, parameter that shows tendency to replicate in both America and Chile. In consequence to these data, a narrative review of the literature concerning the epidemiological profile of the different forms of oral cancer in the past 15 years was done. The diagnosis of oral cancer crosses transversely the Dental Science, forcing us to establish triads of work between oral and maxillofacial surgeons, pathologists and dentists of the various specialties, so as to allow a timely research, appropriate biopsies and histopathological studies finishes with the purpose of, on the one hand, obtain timely and accurate diagnostics, in addition, maintaining the epidemiological indicators.

  19. Dynamics behind the scale up of evidence-based obesity prevention: protocol for a multi-site case study of an electronic implementation monitoring system in health promotion practice.

    Science.gov (United States)

    Conte, Kathleen P; Groen, Sisse; Loblay, Victoria; Green, Amanda; Milat, Andrew; Persson, Lina; Innes-Hughes, Christine; Mitchell, Jo; Thackway, Sarah; Williams, Mandy; Hawe, Penelope

    2017-12-06

    The effectiveness of many interventions to promote health and prevent disease has been well established. The imperative has therefore shifted from amassing evidence about efficacy to scale-up to maximise population-level health gains. Electronic implementation monitoring, or 'e-monitoring', systems have been designed to assist and track the delivery of preventive policies and programs. However, there is little evidence on whether e-monitoring systems improve the dissemination, adoption, and ongoing delivery of evidence-based preventive programs. Also, given considerable difficulties with e-monitoring systems in the clinical sector, scholars have called for a more sophisticated re-examination of e-monitoring's role in enhancing implementation. In the state of New South Wales (NSW), Australia, the Population Health Information Management System (PHIMS) was created to support the dissemination of obesity prevention programs to 6000 childcare centres and elementary schools across all 15 local health districts. We have established a three-way university-policymaker-practice research partnership to investigate the impact of PHIMS on practice, how PHIMS is used, and how achievement of key performance indicators of program adoption may be associated with local contextual factors. Our methods encompass ethnographic observation, key informant interviews and participatory workshops for data interpretation at a state and local level. We use an on-line social network analysis of the collaborative relationships across local health district health promotion teams to explore the relationship between PHIMS use and the organisational structure of practice. Insights will be sensitised by institutional theory, practice theory and complex adaptive system thinking, among other theories which make sense of socio-technical action. Our working hypothesis is that the science of getting evidence-based programs into practice rests on an in-depth understanding of the role they play in the on

  20. Development of an Evidence-Informed Blog to Promote Healthy Eating Among Mothers: Use of the Intervention Mapping Protocol.

    Science.gov (United States)

    Dumas, Audrée-Anne; Lemieux, Simone; Lapointe, Annie; Provencher, Véronique; Robitaille, Julie; Desroches, Sophie

    2017-05-19

    Low adherence to dietary guidelines and a concurrent rise of obesity-related chronic diseases emphasize the need for effective interventions to promote healthy eating. There is growing recognition that behavior change interventions should draw on theories of behavior change. Online interventions grounded in theory lead to increased effectiveness for health behavior change; however, few theory-driven social media-based health promotion interventions have been described in the literature. The objective of this study was to describe the application of the Intervention Mapping (IM) protocol to develop an evidence-informed blog to promote healthy eating among French-Canadian mothers of preschool and school-aged children. The following six steps of the IM protocol were performed. In Step 1, a preliminary needs assessment included a literature search on theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults (ie, knowledge, beliefs about capabilities, beliefs about consequences, intention/goals) and a qualitative study including focus groups to identify female Internet users' perceptions of their use of healthy eating blogs. In Step 2, two behavioral outcomes were selected (ie, increase daily intakes of Vegetables and Fruits and Milk and Alternatives of mothers to reach Canadian dietary recommendations) and subsequently divided into six performance objectives inspired by national and international dietary recommendations such as planning for healthy meals. A matrix of change objectives was then created by crossing performance objectives with theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults. Step 3 consisted of selecting theory-based intervention methods (eg, modeling and goal setting) and translating them into practical applications for the context of a dietary intervention delivered through a blog. A 6-month intervention was developed in Step 4 in which we aimed to

  1. Analisis Data Digital Evidence pada Layanan Voice Over Internet Protocol (VoIP

    Directory of Open Access Journals (Sweden)

    Muhamad Arsad Adam

    2016-11-01

    Full Text Available Teknologi  VoIP  (Voice  Over  Internet  Protocol merupakan  teknologi  yang  mampu  melewatkan  panggilan  suara, video  dan  data  dalam  jaringan  IP.  Voice  over  Internet  Protocol (VoIP  dalam  teknologi  komunikasi  cukup  signifikan  sehingga tidak  terlepas  dari  kejahatan  cybercrime,  Teknologi  VoIP  dapat disalahgunakan  untuk  melakukan  tindakan  kejahatan  jarak  jauh sehingga  diperlukan  langkah-langkah  investigasi  jika  terjadi masalah.  Menemukan  artefact  pada  Infrastruktur  VoIP merupakan tantangan tersendiri. WireSharks salah satu tool yang digunakan  dalam  investigasi  ini.  Metode  yang  digunakan  adalah DFIF  yang  terdiri  tahapan  adalah  Collection,  Examination, Analysis, dan Report and Documentation. Investigasi pada layanan VoIP  dapat  berhasil  dilakukan  dengan  menemukan  data  digital evidence  di  layer  5.  Tujuan  Penelitian  ini  yaitu  Mengetahui Karakteristik Data Digital berupa suara pada layanan Voice Over IP  dan  Menganalisis  Data  Digital  berupa  suara  pada  layanan Voice Over IP. Hasil dari penelitian ini barang bukti digital yang berupa  percakapan  yang  dapat  dipertanggungjawabkan  dalam pengadilan..Kata kunci— Data, Evidence, Forensik,Network, VoIP

  2. An Evidence-Based Protocol for Antibiotic Use Prior to Cystoscopy Decreases Antibiotic Use without Impacting Post-Procedural Symptomatic Urinary Tract Infection Rates.

    Science.gov (United States)

    Gregg, Justin R; Bhalla, Rohan G; Cook, J Paul; Kang, Caroline; Dmochowski, Roger; Talbot, Thomas R; Barocas, Daniel A

    2018-04-01

    Symptomatic urinary tract infection is a complication of office based cystourethroscopy. Studies are mixed regarding the efficacy of antibiotic prophylaxis to prevent urinary tract infections. Our aim was to develop and evaluate an evidence-based protocol that reduces unnecessary antibiotic use while avoiding an increase in urinary tract infections. We created a clinic antibiogram based on all urology office visits performed during a 2-year period. Bacterial resistance rates, institutional risk related data and clinical guidelines were applied to create a protocol for antibiotic administration before cystourethroscopy. We then analyzed 1,245 consecutive patients without a renal transplant who underwent outpatient cystourethroscopy, including 610 after protocol initiation. Urinary tract infection rates and antibiotic use were analyzed for an association with the protocol change using the Fisher exact test. Cultures had an overall 20% rate of resistance to fluoroquinolones, representing 40% of the cultures that grew Escherichia coli. Before the protocol change 602 of 635 patients (94.8%) received a preprocedural antibiotic compared to 426 of 610 (69.9%) after protocol initiation (p urinary tract infection prior to the protocol change while 16 (2.6%) had a urinary tract infection after the change (p = 0.69). Regarding resistance, fluoroquinolone resistant organisms grew in the cultures of 12 of 19 patients (63.2%) with a urinary tract infection before the protocol change compared to 5 of 16 (31.3%) with a urinary tract infection after the change. Recent antibiotic administration, hospitalization and chronic catheterization were associated with urinary tract infection in the entire cohort (all p ≤0.01). A local antibiogram with infection related risk data effectively risk stratifies patients before cystourethroscopy, decreasing the use of antibiotics without increasing the rate of symptomatic urinary tract infection. Copyright © 2018 American Urological Association

  3. Economic evidence for the prevention and treatment of atopic eczema: a protocol for a systematic review.

    Science.gov (United States)

    Sach, Tracey Helen; McManus, Emma; Mcmonagle, Christopher; Levell, Nick

    2016-05-27

    Eczema, synonymous with atopic eczema or atopic dermatitis, is a chronic skin disease that has a similar impact on health-related quality of life as other chronic diseases. The proposed research aims to provide a comprehensive systematic assessment of the economic evidence base available to inform economic modelling and decision making on interventions to prevent and treat eczema at any stage of the life course. Whilst the Global Resource of Eczema Trials (GREAT) database collects together the effectiveness evidence for eczema, there is currently no such systematic resource on the economics of eczema. It is important to gain an overview of the current state of the art of economic methods in the field of eczema in order to strengthen the economic evidence base further. The proposed study is a systematic review of the economic evidence surrounding interventions for the prevention and treatment of eczema. Relevant search terms will be used to search MEDLINE, EMBASE, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, National Health Service (NHS) Economic Evaluation Database, Health Technology Assessment, Cumulative Index to Nursing and Allied Health Literature, EconLit, Scopus, Cost-Effectiveness Analysis Registry and Web of Science in order to identify relevant evidence. To be eligible for inclusion studies will be primary empirical studies evaluating the cost, utility or full economic evaluation of interventions for preventing or treating eczema. Two reviewers will independently assess studies for eligibility and perform data abstraction. Evidence tables will be produced presenting details of study characteristics, costing methods, outcome methods and quality assessment. The methodological quality of studies will be assessed using accepted checklists. The systematic review is being undertaken to identify the type of economic evidence available, summarise the results of the available

  4. Implementation of an evidence-based intervention to improve the wellbeing of people with dementia and their carers: study protocol for 'Care of People with dementia in their Environments (COPE)' in the Australian context.

    Science.gov (United States)

    Clemson, Lindy; Laver, Kate; Jeon, Yun-Hee; Comans, Tracy A; Scanlan, Justin; Rahja, Miia; Culph, Jennifer; Low, Lee-Fay; Day, Sally; Cations, Monica; Crotty, Maria; Kurrle, Susan; Piersol, Catherine; Gitlin, Laura N

    2018-05-09

    There are effective non-pharmacological treatment programs that reduce functional disability and changed behaviours in people with dementia. However, these programs (such as the Care of People with dementia in their Environments (COPE) program) are not widely available. The primary aim of this study is to determine the strategies and processes that enable the COPE program to be implemented into existing dementia care services in Australia. This study uses a mixed methods approach to test an implementation strategy. The COPE intervention (up to ten consultations with an occupational therapist and up to two consultations with a nurse) will be implemented using a number of strategies including planning (such as developing and building relationships with dementia care community service providers), educating (training nurses and occupational therapists in how to apply the intervention), restructuring (organisations establishing referral systems; therapist commitment to provide COPE to five clients following training) and quality management (coaching, support, reminders and fidelity checks). Qualitative and quantitative data will contribute to understanding how COPE is adopted and implemented. Feasibility, fidelity, acceptability, uptake and service delivery contexts will be explored and a cost/benefit evaluation conducted. Client outcomes of activity engagement and caregiver wellbeing will be assessed in a pragmatic pre-post evaluation. While interventions that promote independence and wellbeing are effective and highly valued by people with dementia and their carers, access to such programs is limited. Barriers to translation that have been previously identified are addressed in this study, including limited training opportunities and a lack of confidence in clinicians working with complex symptoms of dementia. A strength of the study is that it involves implementation within different types of existing services, such as government and private providers, so the study

  5. Studying protocol-based pain management in the emergency department

    Directory of Open Access Journals (Sweden)

    Akkamahadevi Patil

    2017-01-01

    Full Text Available Background: Majority of the patients presenting to emergency department (ED have pain. ED oligoanalgesia remains a challenge. Aims: This study aims to study the effect of implementing a protocol-based pain management in the ED on (1 time to analgesia and (2 adequacy of analgesia obtained. Settings and Design: Cross-sectional study in the ED. Methods: Patients aged 18–65 years of age with pain of numeric rating scale (NRS ≥4 were included. A series of 100 patients presenting before introduction of the protocol-based pain management were grouped “pre-protocol,” and managed as per existing practice. Following this, a protocol for management of all patients presenting to ED with pain was implemented. Another series of 100 were grouped as “post-protocol” and managed as per the new pain management protocol. The data of patients from both the groups were collected and analyzed. Statistical Analysis Used: Descriptive statistical tests such as percentage, mean and standard deviation and inferential statistical tests such as Pearson coefficient, Student's t-test were applied. Differences were interpreted as significant when P < 0.05. Results: Mean time to administer analgesic was significantly lesser in the postprotocol group (preprotocol 20.30 min vs. postprotocol 13.05 min; P < 0.001. There was significant difference in the pain relief achieved (change in NRS between the two groups, with greater pain relief achieved in the postprotocol group (preprotocol group 4.6800 vs. postprotocol group 5.3600; P < 0.001. Patients' rating of pain relief (assessed on E5 scale was significantly higher in the postprotocol group (preprotocol 3.91 vs. postprotocol 4.27; P = 0.001. Patients' satisfaction (North American Spine Society scale with the overall treatment was also compared and found to be significantly higher in postprotocol group (mean: preprotocol 1.59 vs. postprotocol 1.39; P = 0.008. Conclusion: Protocol-based pain management provided timely and

  6. MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

    Science.gov (United States)

    Benyamin, Ramsin M; Staats, Peter S

    2015-01-01

    efficacy outcome measures include the proportion of Zurich Claudication Questionnaire (ZCQ) and Numeric Pain Rating Scale (NPRS) responders from baseline to follow-up using validated MIC thresholds. Improvement in ZCQ domains of ≥ 0.5 is considered significant, and a Patient Satisfaction score of at least 2.5 represents a satisfied patient. A reduction of ≥ 2 points in NPRS is considered significant pain relief. The primary safety outcome measure is the incidence of device- and/or procedure-related adverse events. Descriptive summaries will be presented by randomized group for all outcome measures at baseline and follow-up time points. Inferential statistical analysis will be conducted to determine significant differences related to functional improvement, pain relief, and safety outcomes. Primary study results will be presented based on one-year follow-up data, with an interim analysis report when 6-month follow-up data become available. Patients are not blinded due to significant differences in treatment protocols between study groups. Also, since neither study arm is focused on treatment of radicular pain, there may be a higher non-responder rate for both groups versus standard of care due to study restrictions on adjunctive pain therapies. This prospective, multi-center, randomized controlled study will provide Level I evidence of the safety and effectiveness of mild versus ESIs in managing neurogenic claudication symptoms in LSS patients.

  7. 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

  8. Characterization of a new protocol for mortar dating: 13C and 14C evidences

    International Nuclear Information System (INIS)

    Marzaioli, F.

    2011-01-01

    This paper reviews the present knowledge about the analysis of mortars in the framework of artworks absolute chronology determination with the aim to formulate a new methodology capable of systematically and accurately estimating the age of these constructive and/or art materials. The core of the proposed methodology is represented by a physical procedure (ultrasonication) selecting only carbonaceous materials represented by carbonates formed after the absorption of atmospheric Co2 (carbonatation) by mortars (binder) during their setting. With the aim to evaluate the procedure efficiency in the isolation of binder signal from the most important source of carbonates, the proposed procedure was tested on a series of laboratory mortars produced, in a simplified version, in the laboratory environment. Mortar production was characterized by means of a series of measurements allowing to draw important indications about the applied procedure. The radiocarbon value of isolated binder carbonates was compared with the Co2 signal sampled form laboratory air during mortar setting. The observed results confirmed preliminarily the good protocol accuracy for radiocarbon dating suggesting its capability for the application to real study cases.

  9. Protocols to Study Growth and Metabolism in Drosophila.

    Science.gov (United States)

    Strassburger, Katrin; Teleman, Aurelio A

    2016-01-01

    Signaling pathways such as the insulin/insulin-like growth factor pathway concurrently regulate organismal growth and metabolism. Drosophila has become a popular model system for studying both organismal growth and metabolic regulation. Care must be taken, however, when assessing such phenotypes because they are quantitative in nature, and influenced by environment. This chapter first describes how to control animal age and nutrient availability, since growth and metabolism are sensitive to these parameters. It then provides protocols for measuring tissue growth, cell size, and metabolic parameters such as stored lipids and glycogen, and circulating sugars.

  10. Biomass to energy : GHG reduction quantification protocols and case study

    International Nuclear Information System (INIS)

    Reusing, G.; Taylor, C.; Nolan, W.; Kerr, G.

    2009-01-01

    With the growing concerns over greenhouses gases and their contribution to climate change, it is necessary to find ways of reducing environmental impacts by diversifying energy sources to include non-fossil fuel energy sources. Among the fastest growing green energy sources is energy from waste facilities that use biomass that would otherwise be landfilled or stockpiled. The quantification of greenhouse gas reductions through the use of biomass to energy systems can be calculated using various protocols and methodologies. This paper described each of these methodologies and presented a case study comparing some of these quantification methodologies. A summary and comparison of biomass to energy greenhouse gas reduction protocols in use or under development by the United Nations, the European Union, the Province of Alberta and Environment Canada was presented. It was concluded that regulatory, environmental pressures, and public policy will continue to impact the practices associated with biomass processing or landfill operations, such as composting, or in the case of landfills, gas collection systems, thus reducing the amount of potential credit available for biomass to energy facility offset projects. 10 refs., 2 tabs., 6 figs

  11. Biomass to energy : GHG reduction quantification protocols and case study

    Energy Technology Data Exchange (ETDEWEB)

    Reusing, G.; Taylor, C. [Conestoga - Rovers and Associates, Waterloo, ON (Canada); Nolan, W. [Liberty Energy, Hamilton, ON (Canada); Kerr, G. [Index Energy, Ajax, ON (Canada)

    2009-07-01

    With the growing concerns over greenhouses gases and their contribution to climate change, it is necessary to find ways of reducing environmental impacts by diversifying energy sources to include non-fossil fuel energy sources. Among the fastest growing green energy sources is energy from waste facilities that use biomass that would otherwise be landfilled or stockpiled. The quantification of greenhouse gas reductions through the use of biomass to energy systems can be calculated using various protocols and methodologies. This paper described each of these methodologies and presented a case study comparing some of these quantification methodologies. A summary and comparison of biomass to energy greenhouse gas reduction protocols in use or under development by the United Nations, the European Union, the Province of Alberta and Environment Canada was presented. It was concluded that regulatory, environmental pressures, and public policy will continue to impact the practices associated with biomass processing or landfill operations, such as composting, or in the case of landfills, gas collection systems, thus reducing the amount of potential credit available for biomass to energy facility offset projects. 10 refs., 2 tabs., 6 figs.

  12. [Colombia 2015 National Mental Health Survey. Study Protocol].

    Science.gov (United States)

    Gómez-Restrepo, Carlos; de Santacruz, Cecilia; Rodriguez, María Nelcy; Rodriguez, Viviana; Tamayo Martínez, Nathalie; Matallana, Diana; Gonzalez, Lina M

    2016-12-01

    The 2015 National Mental Health Survey (NMHS) is the fourth mental survey conducted in Colombia, and is part of the National System of Surveys and Population Studies for health. A narrative description is used to explain the background, references, the preparation, and characteristics of the 2015 NMHS. The 2015 NMHS and its protocol emerge from the requirements that support the national and international policies related to mental health. Together with the Ministry of Health and Social Protection, the objectives, the collection tools, the sample, and the operational plan are defined. The main objective was to obtain updated information about the mental health, mental problems and disorders, accessibility to health services, and an evaluation of health conditions. Participants were inhabitants from both urban and rural areas, over 7 years old, and in whom the comprehension of social determinants and equity were privileged. An observational cross-sectional design with national, regional and age group representativity, was used. The age groups selected were 7-11, 12-17, and over 18 years old. The regions considered were Central, Orient, Atlantic, Pacific, and Bogota. The calculated sample had a minimum of 12,080 and a maximum of 14,496 participants. A brief summary of the protocol of the 2015 NMHS is presented. The full document with all the collection tools can be consulted on the Health Ministry webpage. Copyright © 2016. Publicado por Elsevier España.

  13. Prenatal diagnosis and prevention of toxoplasmosis in pregnant women in Northern Vietnam: study protocol.

    Science.gov (United States)

    Smit, G Suzanne A; Vu, Thi Lam Binh; Do, Trung Dung; Speybroeck, Niko; Devleesschauwer, Brecht; Padalko, Elizaveta; Roets, Ellen; Dorny, Pierre

    2017-05-25

    In Vietnam, no systematic prenatal toxoplasmosis screening is in place, and only few studies have assessed the prevalence and importance of this zoonotic parasite infection. In addition, no studies have been conducted to assess the risk factors associated with toxoplasmosis. This study protocol was developed to determine the seroprevalence of toxoplasmosis in pregnant women in Hanoi and Thai Binh, Northern Vietnam, and to evaluate the association with risk factors and congenital toxoplasmosis. The protocol was developed in a way that it could potentially evolve into a countrywide prenatal diagnosis and prevention program, with the main focus on primary prevention. The collaborating gynaecologists will invite eligible pregnant women attending antenatal care for the first time to participate in the study. At first consult, information about toxoplasmosis and its prevention will be provided. All participants will be asked to fill in a questionnaire, which is designed to analyse socio-demographic and biologically plausible risk factors associated with toxoplasmosis, and blood samples will be collected to determine the seroprevalence of toxoplasmosis in pregnant women. In case there is suspicion of a primary infection during pregnancy, the concerned women will be followed-up by the gynaecologists according to a predefined protocol. Every participant will be informed on her serological status, risk factors and prevention measures and is offered appropriate medical information and medical follow-up if required. The hypothesis is that congenital toxoplasmosis is an important but currently under-diagnosed public health problem in Vietnam. This study can strengthen sustainable control of toxoplasmosis in Vietnam, provide a protocol for prenatal diagnosis, boost overall awareness, improve the knowledge about toxoplasmosis prevention and can be essential for evidence-based health policy.

  14. Protocol of study and pursuit of the radioinduced burns

    International Nuclear Information System (INIS)

    Portas, Mercedes; Glustein, Daniel; Pomerane, Armando; Peragallo, Mabel; Guzman, Alejandra; Ciordia, Irma; Genovese, Jorge; Cymberknoh, Manuel; Dubner, Diana; Michelin, Severino; Perez, Maria del Rosario; Trano, Jose Luis Di; Gisone, Pablo

    2001-01-01

    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)

  15. Soil examination for a forensic trace evidence laboratory-Part 3: A proposed protocol for the effective triage and management of soil examinations.

    Science.gov (United States)

    Woods, Brenda; Lennard, Chris; Kirkbride, K Paul; Robertson, James

    2016-05-01

    In the past, forensic soil examination was a routine aspect of forensic trace evidence examinations. The apparent need for soil examinations then went through a period of decline and with it the capability of many forensic laboratories to carry out soil examinations. In more recent years, interest in soil examinations has been renewed due-at least in part-to soil examinations contributing to some high profile investigations. However, much of this renewed interest has been in organisations with a primary interest in soil and geology rather than forensic science. We argue the need to reinstate soil examinations as a trace evidence sub-discipline within forensic science laboratories and present a pathway to support this aim. An examination procedure is proposed that includes: (i) appropriate sample collection and storage by qualified crime scene examiners; (ii) exclusionary soil examinations by trace evidence scientists within a forensic science laboratory; (iii) inclusionary soil examinations by trace evidence scientists within a forensic science laboratory; and (iv) higher-level examination of soils by specialist soil scientists and palynologists. Soil examinations conducted by trace evidence scientists will be facilitated if the examinations are conducted using the instrumentation routinely used by these examiners. Hence, the proposed examination protocol incorporates instrumentation in routine use in a forensic trace evidence laboratory. Finally, we report on an Australian soil scene variability study and a blind trial that demonstrate the utility of the proposed protocol for the effective triage and management of soil samples by forensic laboratories. Crown Copyright © 2016. Published by Elsevier Ireland Ltd. All rights reserved.

  16. 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

  17. Constant round group key agreement protocols: A comparative study

    NARCIS (Netherlands)

    Makri, E.; Konstantinou, Elisavet

    2011-01-01

    The scope of this paper is to review and evaluate all constant round Group Key Agreement (GKA) protocols proposed so far in the literature. We have gathered all GKA protocols that require 1,2,3,4 and 5 rounds and examined their efficiency. In particular, we calculated each protocol’s computation and

  18. Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.

    Science.gov (United States)

    González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Riera, Antonio; Llorca, Ginés; Traver, Francisco; Haro, Gonzalo; Palop, Vicente; Lera, Guillem; Romeu, José Enrique; Botella, Cristina

    2015-10-31

    Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied. The study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed. Although the effectiveness of face-to-face transdiagnostic protocols has been

  19. Protocol - realist and meta-narrative evidence synthesis: Evolving Standards (RAMESES

    Directory of Open Access Journals (Sweden)

    Westhorp Gill

    2011-08-01

    Full Text Available Abstract Background There is growing interest in theory-driven, qualitative and mixed-method approaches to systematic review as an alternative to (or to extend and supplement conventional Cochrane-style reviews. These approaches offer the potential to expand the knowledge base in policy-relevant areas - for example by explaining the success, failure or mixed fortunes of complex interventions. However, the quality of such reviews can be difficult to assess. This study aims to produce methodological guidance, publication standards and training resources for those seeking to use the realist and/or meta-narrative approach to systematic review. Methods/design We will: [a] collate and summarise existing literature on the principles of good practice in realist and meta-narrative systematic review; [b] consider the extent to which these principles have been followed by published and in-progress reviews, thereby identifying how rigour may be lost and how existing methods could be improved; [c] using an online Delphi method with an interdisciplinary panel of experts from academia and policy, produce a draft set of methodological steps and publication standards; [d] produce training materials with learning outcomes linked to these steps; [e] pilot these standards and training materials prospectively on real reviews-in-progress, capturing methodological and other challenges as they arise; [f] synthesise expert input, evidence review and real-time problem analysis into more definitive guidance and standards; [g] disseminate outputs to audiences in academia and policy. The outputs of the study will be threefold: 1. Quality standards and methodological guidance for realist and meta-narrative reviews for use by researchers, research sponsors, students and supervisors 2. A 'RAMESES' (Realist and Meta-review Evidence Synthesis: Evolving Standards statement (comparable to CONSORT or PRISMA of publication standards for such reviews, published in an open

  20. Conservative Treatment Protocol for Keratocystic Odontogenic Tumour: a Follow-up Study of 3 Cases

    Directory of Open Access Journals (Sweden)

    Gülsün Yildirim

    2010-07-01

    Full Text Available Background: The keratocystic odontogenic tumour is classified as a developmental cyst derived from the enamel organ or from the dental lamina. The treatment of keratocystic odontogenic tumour of the jaw remains controversial. The aim of this study was to report the outcome of our conservative treatment protocol for keratocystic odontogenic tumour.Methods: Three patients with different complaints referred to Oral and Maxillofacial Surgery Clinic, Faculty of Dentistry, Selçuk University. Initial biopsy was carried out in all patients and keratocystic odontogenic tumours was diagnosed subsequent to histopathological examination. The patients with keratocystic odontogenic tumours were treated by enucleation followed by open packing. This conservative treatment protocol was selected because of existing young aged patients. The average follow-up duration of the cases was 2 years.Results: Out of 3 cases, 2 lesions were present in mandible and 1 lesion in maxilla. There was no evidence of recurrence during follow-up. All the cases were monitored continuously with panoramic radiographs, computed tomography and clinical evaluations.Conclusions: This conservative treatment protocol for keratocystic odontogenic tumours, based on enucleation followed by open packing would be a possible choice with a view of offering low recurrence rate and low morbidity rate particularly in young patients.

  1. Evaluation of forensic DNA mixture evidence: protocol for evaluation, interpretation, and statistical calculations using the combined probability of inclusion.

    Science.gov (United States)

    Bieber, Frederick R; Buckleton, John S; Budowle, Bruce; Butler, John M; Coble, Michael D

    2016-08-31

    The evaluation and interpretation of forensic DNA mixture evidence faces greater interpretational challenges due to increasingly complex mixture evidence. Such challenges include: casework involving low quantity or degraded evidence leading to allele and locus dropout; allele sharing of contributors leading to allele stacking; and differentiation of PCR stutter artifacts from true alleles. There is variation in statistical approaches used to evaluate the strength of the evidence when inclusion of a specific known individual(s) is determined, and the approaches used must be supportable. There are concerns that methods utilized for interpretation of complex forensic DNA mixtures may not be implemented properly in some casework. Similar questions are being raised in a number of U.S. jurisdictions, leading to some confusion about mixture interpretation for current and previous casework. Key elements necessary for the interpretation and statistical evaluation of forensic DNA mixtures are described. Given the most common method for statistical evaluation of DNA mixtures in many parts of the world, including the USA, is the Combined Probability of Inclusion/Exclusion (CPI/CPE). Exposition and elucidation of this method and a protocol for use is the focus of this article. Formulae and other supporting materials are provided. Guidance and details of a DNA mixture interpretation protocol is provided for application of the CPI/CPE method in the analysis of more complex forensic DNA mixtures. This description, in turn, should help reduce the variability of interpretation with application of this methodology and thereby improve the quality of DNA mixture interpretation throughout the forensic community.

  2. Quality of Mobile Phone and Tablet Mobile Apps for Speech Sound Disorders: Protocol for an Evidence-Based Appraisal.

    Science.gov (United States)

    Furlong, Lisa M; Morris, Meg E; Erickson, Shane; Serry, Tanya A

    2016-11-29

    Although mobile apps are readily available for speech sound disorders (SSD), their validity has not been systematically evaluated. This evidence-based appraisal will critically review and synthesize current evidence on available therapy apps for use by children with SSD. The main aims are to (1) identify the types of apps currently available for Android and iOS mobile phones and tablets, and (2) to critique their design features and content using a structured quality appraisal tool. This protocol paper presents and justifies the methods used for a systematic review of mobile apps that provide intervention for use by children with SSD. The primary outcomes of interest are (1) engagement, (2) functionality, (3) aesthetics, (4) information quality, (5) subjective quality, and (6) perceived impact. Quality will be assessed by 2 certified practicing speech-language pathologists using a structured quality appraisal tool. Two app stores will be searched from the 2 largest operating platforms, Android and iOS. Systematic methods of knowledge synthesis shall include searching the app stores using a defined procedure, data extraction, and quality analysis. This search strategy shall enable us to determine how many SSD apps are available for Android and for iOS compatible mobile phones and tablets. It shall also identify the regions of the world responsible for the apps' development, the content and the quality of offerings. Recommendations will be made for speech-language pathologists seeking to use mobile apps in their clinical practice. This protocol provides a structured process for locating apps and appraising the quality, as the basis for evaluating their use in speech pathology for children in English-speaking nations. ©Lisa M Furlong, Meg E Morris, Shane Erickson, Tanya A Serry. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.11.2016.

  3. Study protocol: Mother and Infant Nutritional Assessment (MINA) cohort study in Qatar and Lebanon.

    Science.gov (United States)

    Naja, Farah; Nasreddine, Lara; Al Thani, Al Anoud; Yunis, Khaled; Clinton, Michael; Nassar, Anwar; Farhat Jarrar, Sara; Moghames, Patricia; Ghazeeri, Ghina; Rahman, Sajjad; Al-Chetachi, Walaa; Sadoun, Eman; Lubbad, Nibal; Bashwar, Zelaikha; Bawadi, Hiba; Hwalla, Nahla

    2016-05-04

    The Middle East and North Africa region harbors significant proportions of stunting and wasting coupled with surging rates of non-communicable diseases (NCDs). Recent evidence identified nutrition during the first 1000 days of life as a common denominator not only for optimal growth but also for curbing the risk of NCDs later in life. The main objective of this manuscript is to describe the protocol of the first cohort in the region to investigate the association of nutrition imbalances early in life with birth outcomes, growth patterns, as well as early determinants of non-communicable diseases. More specifically the cohort aims to 1) examine the effects of maternal and early child nutrition and lifestyle characteristics on birth outcomes and growth patterns and 2) develop evidence-based nutrition and lifestyle guidelines for pregnant women and young children. A multidisciplinary team of researchers was established from governmental and private academic and health sectors in Lebanon and Qatar to launch the Mother and Infant Nutritional Assessment 3-year cohort study. Pregnant women (n = 250 from Beirut, n = 250 from Doha) in their first trimester are recruited from healthcare centers in Beirut, Lebanon and Doha, Qatar. Participants are interviewed three times during pregnancy (once every trimester) and seven times at and after delivery (when the child is 4, 6, 9, 12, 18, and 24 months old). Delivery and birth data is obtained from hospital records. Data collection includes maternal socio-demographic and lifestyle characteristics, dietary intake, anthropometric measurements, and household food security data. For biochemical assessment of various indicators of nutritional status, a blood sample is obtained from women during their first trimester. Breastfeeding and complementary feeding practices, dietary intake, as well as anthropometric measurements of children are also examined. The Delphi technique will be used for the development of the nutrition and lifestyle

  4. Safe refeeding management of anorexia nervosa inpatients: an evidence-based protocol.

    Science.gov (United States)

    Hofer, Michael; Pozzi, Antonio; Joray, Maya; Ott, Rebecca; Hähni, Florence; Leuenberger, Michéle; von Känel, Roland; Stanga, Zeno

    2014-05-01

    Anorexia nervosa is associated with several serious medical complications related to malnutrition, severe weight loss, and low levels of micronutrients. The refeeding phase of these high-risk patients bears a further threat to health and potentially fatal complications. The objective of this study was to examine complications due to refeeding of patients with anorexia nervosa, as well as their mortality rate after the implementation of guidelines from the European Society of Clinical Nutrition and Metabolism. We analyzed retrospective, observational data of a consecutive, unselected anorexia nervosa cohort during a 5-y period. The sample consisted of 65 inpatients, 14 were admitted more than once within the study period, resulting in 86 analyzed cases. Minor complications associated with refeeding during the first 10 d (replenishing phase) were recorded in nine cases (10.5%), four with transient pretibial edemas and three with organ dysfunction. In two cases, a severe hypokalemia occurred. During the observational phase of 30 d, 16 minor complications occurred in 14 cases (16.3%). Six infectious and 10 non-infectious complications occurred. None of the patients with anorexia nervosa died within a follow-up period of 3 mo. Our data demonstrate that the seriousness and rate of complications during the replenishment phase in this high-risk population can be kept to a minimum. The findings indicate that evidence-based refeeding regimens, such as our guidelines are able to reduce complications and prevent mortality. Despite anorexia nervosa, our sample were affected by serious comorbidities, no case met the full diagnostic criteria for refeeding syndrome. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. 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

  6. A Study of Shared-Memory Mutual Exclusion Protocols Using CADP

    Science.gov (United States)

    Mateescu, Radu; Serwe, Wendelin

    Mutual exclusion protocols are an essential building block of concurrent systems: indeed, such a protocol is required whenever a shared resource has to be protected against concurrent non-atomic accesses. Hence, many variants of mutual exclusion protocols exist in the shared-memory setting, such as Peterson's or Dekker's well-known protocols. Although the functional correctness of these protocols has been studied extensively, relatively little attention has been paid to their non-functional aspects, such as their performance in the long run. In this paper, we report on experiments with the performance evaluation of mutual exclusion protocols using Interactive Markov Chains. Steady-state analysis provides an additional criterion for comparing protocols, which complements the verification of their functional properties. We also carefully re-examined the functional properties, whose accurate formulation as temporal logic formulas in the action-based setting turns out to be quite involved.

  7. 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.

  8. 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.

  9. 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

  10. Group schema therapy for eating disorders: study protocol.

    Science.gov (United States)

    Calvert, Fiona; Smith, Evelyn; Brockman, Rob; Simpson, Susan

    2018-01-01

    The treatment of eating disorders is a difficult endeavor, with only a relatively small proportion of clients responding to and completing standard cognitive behavioural therapy (CBT). Given the prevalence of co-morbidity and complex personality traits in this population, Schema Therapy has been identified as a potentially viable treatment option. A case series of Group Schema Therapy for Eating Disorders (ST-E-g) yielded positive findings and the study protocol outlined in this article aims to extend upon these preliminary findings to evaluate group Schema Therapy for eating disorders in a larger sample ( n  = 40). Participants undergo a two-hour assessment where they complete a number of standard questionnaires and their diagnostic status is ascertained using the Eating Disorder Examination. Participants then commence treatment, which consists of 25 weekly group sessions lasting for 1.5 h and four individual sessions. Each group consists of five to eight participants and is facilitated by two therapists, at least one of who is a registered psychologist trained on schema therapy. The primary outcome in this study is eating disorder symptom severity. Secondary outcomes include: cognitive schemas, self-objectification, general quality of life, self-compassion, schema mode presentations, and Personality Disorder features. Participants complete psychological measures and questionnaires at pre, post, six-month and 1-year follow-up. This study will expand upon preliminary research into the efficacy of group Schema Therapy for individuals with eating disorders. If group Schema Therapy is shown to reduce eating disorder symptoms, it will hold considerable promise as an intervention option for a group of disorders that is typically difficult to treat. ACTRN12615001323516. Registered: 2/12/2015 (retrospectively registered, still recruiting).

  11. A Study on IP Network Recovery through Routing Protocols

    Directory of Open Access Journals (Sweden)

    K. Karthik

    2016-09-01

    Full Text Available Internet has taken major role in our communication infrastructure. Such that requirement of internet availability and reliability has increasing accordingly. The major network failure reasons are failure of node and failure of link among the nodes. This can reduce the performance of major applications in an IP networks. The network recovery should be fast enough so that service interruption of link or node failure. The new path taken by the diverted traffic can be computed either at the time of failures or before failures. These mechanisms are known as Reactive and Proactive protocols respectively. In this paper, we surveyed reactive and proactive protocols mechanisms for IP network recovery.

  12. Protocols for Migration and Invasion Studies in Prostate Cancer.

    Science.gov (United States)

    van de Merbel, Arjanneke F; van der Horst, Geertje; Buijs, Jeroen T; van der Pluijm, Gabri

    2018-01-01

    Prostate cancer is the most common malignancy diagnosed in men in the western world. The development of distant metastases and therapy resistance are major clinical problems in the management of prostate cancer patients. In order for prostate cancer to metastasize to distant sites in the human body, prostate cancer cells have to migrate and invade neighboring tissue. Cancer cells can acquire a migratory and invasive phenotype in several ways, including single cell and collective migration. As a requisite for migration, epithelial prostate cancer cells often need to acquire a motile, mesenchymal-like phenotype. This way prostate cancer cells often lose polarity and epithelial characteristics (e.g., expression of E-cadherin homotypic adhesion receptor), and acquire mesenchymal phenotype (for example, cytoskeletal rearrangements, enhanced expression of proteolytic enzymes and other repertory of integrins). This process is referred to as epithelial-to-mesenchymal transition (EMT). Cellular invasion, one of the hallmarks of cancer, is characterized by the movement of cells through a three-dimensional matrix, resulting in remodeling of the cellular environment. Cellular invasion requires adhesion, proteolysis of the extracellular matrix, and migration of cells. Studying the migratory and invasive ability of cells in vitro represents a useful tool to assess the aggressiveness of solid cancers, including those of the prostate.This chapter provides a comprehensive description of the Transwell migration assay, a commonly used technique to investigate the migratory behavior of prostate cancer cells in vitro. Furthermore, we will provide an overview of the adaptations to the Transwell migration protocol to study the invasive capacity of prostate cancer cells, i.e., the Transwell invasion assay. Finally, we will present a detailed description of the procedures required to stain the Transwell filter inserts and quantify the migration and/or invasion.

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

    OpenAIRE

    Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith AY; Silburn, Sven

    2010-01-01

    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-c...

  14. The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS): a study protocol for a prospective longitudinal study.

    Science.gov (United States)

    Fagher, Kristina; Jacobsson, Jenny; Timpka, Toomas; Dahlström, Örjan; Lexell, Jan

    2016-01-01

    Paralympic sport provides sporting opportunities for athletes with a disability, with the Paralympic Games as the main event. Participation in sport is, however, associated with a significant risk for sustaining injuries and illnesses. Our knowledge of sports-related injuries and illnesses in Paralympic sport is very limited and there are no large-scale epidemiological cohort studies. The purpose here is to present a protocol for a prospective longitudinal study: The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS). An argument-based method for investigation of design problems was used to structure the study protocol. The primary requirement of the protocol is to allow prospective studies over time and include exposure to both training and competition. To reflect the complexity of Paralympic sport with athletes' pre-existing impairments, use of assistive equipment, pain and other and medical issues, it is required that the data collection system is specifically adapted to Paralympic sport. To allow the collection of data, at the same time as there is limited access to coaches and medical personnel, it is advantageous that data can be collected online directly from the athletes. Based on this a self-report athlete monitoring system will be developed, where the athletes can enter data weekly via their mobile phones or lap-tops. Data will be collected from around 100 Swedish Paralympic athletes for approximately 1 year, which will allow us to i) prospectively estimate the annual incidence of sports-related injuries and illnesses and ii) explore risk factors and mechanisms for sustaining sports-related injuries and illnesses based on athlete exposure and training loads. For effective implementation of injury and illness prevention measures, comprehensive epidemiological knowledge is required. This study will be the first prospective longitudinal self-report study of sports-related injuries and illnesses in Paralympic sport over a longer period

  15. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

    2015-01-01

    Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

  16. Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71% were completed according to protocol, 128 (16% discontinued and 42 (5% are still ongoing; for 61 (8% there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55. Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48% protocols and in 205 (49% of the publications. In most published studies (339; 81% this information corresponded between protocol and publication. Most studies were published in English (367; 88%; some in German (25; 6% or both languages (27; 6%. The local investigators were listed as (co-authors in the publications corresponding to 259 (62% studies.Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care

  17. 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....

  18. 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

  19. Development of a systematic observation protocol of physical exposure of the back: a preliminary study.

    Science.gov (United States)

    Tousignant, M; Tougas, G; Rossignol, M; Goulet, L

    2002-04-01

    At present there is no systematic observation protocol for the assessment of the multi-factorial aspects of physical exposure related to the back used within the constraints of occupational epidemiological research. In this context, a new preliminary systematic observation protocol is proposed to assess exposure to physical loading of the back using nine categories of physical risk factors: the SOPE back protocol. The objective of this study was to investigate whether the new protocol can correctly identify the level of exposure related to measured physical loading of the back. The subjects of this closed cohort study were 451 manual workers at a natural gas distribution company. The assessment of exposure was made with the protocol using groups with different job titles. The workers were followed for a 2 yr period to establish the risk of a new occurrence of complete disability related to the back (NOCD back injury) in each job grouping. Based on the median of the total scores derived from the protocol, two levels of exposure were identified (high and low). Taking into account the limitations of this study, the protocol in development may be a good tool to establish two levels of exposure to physical loading of the back in large epidemiological studies of occupational low back pain. Further research is needed to replicate these results with larger samples and to test the reliability and predictive validity of the protocol.

  20. 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

  1. 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

  2. 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

  3. Evidence used in model-based economic evaluations for evaluating pharmacogenetic and pharmacogenomic tests: a systematic review protocol.

    Science.gov (United States)

    Peters, Jaime L; Cooper, Chris; Buchanan, James

    2015-11-11

    Decision models can be used to conduct economic evaluations of new pharmacogenetic and pharmacogenomic tests to ensure they offer value for money to healthcare systems. These models require a great deal of evidence, yet research suggests the evidence used is diverse and of uncertain quality. By conducting a systematic review, we aim to investigate the test-related evidence used to inform decision models developed for the economic evaluation of genetic tests. We will search electronic databases including MEDLINE, EMBASE and NHS EEDs to identify model-based economic evaluations of pharmacogenetic and pharmacogenomic tests. The search will not be limited by language or date. Title and abstract screening will be conducted independently by 2 reviewers, with screening of full texts and data extraction conducted by 1 reviewer, and checked by another. Characteristics of the decision problem, the decision model and the test evidence used to inform the model will be extracted. Specifically, we will identify the reported evidence sources for the test-related evidence used, describe the study design and how the evidence was identified. A checklist developed specifically for decision analytic models will be used to critically appraise the models described in these studies. Variations in the test evidence used in the decision models will be explored across the included studies, and we will identify gaps in the evidence in terms of both quantity and quality. The findings of this work will be disseminated via a peer-reviewed journal publication and at national and international conferences. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. A Performance Study of LEACH and Direct Diffusion Routing Protocols in Wireless Sensor Network

    International Nuclear Information System (INIS)

    Fakher, S.; Sharshar, K.; Moawad, M.I.; Shokair, M.

    2016-01-01

    The Wireless Sensor Network (WSN) is composed of a large number of sensor nodes with limited computation communication, and battery facilities. One of the common applications of this network is environment monitoring through sensing motion, measuring temperature, humidity and radiation. One of the basic activities in WSN is data gathering which represents a great challenge. Many routing protocols are proposed for that network to collect and aggregate the data. The most popular ones are hierarchy and data centric routing protocols. The main goal of this study is to identify the most preferable routing protocol, to be used in each mobility model. This paper studies the performance of LEACH (Low Energy Adaptive Clustering Hierarchy) from hierarchy routing protocol and direct diffusion from data centric routing protocol which is not clarified until now. Moreover, a comparison between LEACH and direct diffusion protocol using NS2 simulator will be made, and an analysis of these protocols will be conducted. The comparison includes packet delivery ratio, throughput, average energy ratio, average delay, network lifetime, and routing overhead. The performance is evaluated by varying the number of sensor nodes under three mobility models Reference Point Group Mobility Model (RPGM), Manhattan and random waypoint mobility model. Simulation results show that LEACH routing protocol has a good performance in RPGM and Manhattan than random waypoint mobility model. Direct diffusion has a good performance in random waypoint mobility model than in RPGM and Manhattan mobility model

  5. Understanding context in knowledge translation: a concept analysis study protocol.

    Science.gov (United States)

    Squires, Janet E; Graham, Ian D; Hutchinson, Alison M; Linklater, Stefanie; Brehaut, Jamie C; Curran, Janet; Ivers, Noah; Lavis, John N; Michie, Susan; Sales, Anne E; Fiander, Michelle; Fenton, Shannon; Noseworthy, Thomas; Vine, Jocelyn; Grimshaw, Jeremy M

    2015-05-01

    To conduct a concept analysis of clinical practice contexts (work environments) that facilitate or militate against the uptake of research evidence by healthcare professionals in clinical practice. This will involve developing a clear definition of context by describing its features, domains and defining characteristics. The context where clinical care is delivered influences that care. While research shows that context is important to knowledge translation (implementation), we lack conceptual clarity on what is context, which contextual factors probably modify the effect of knowledge translation interventions (and hence should be considered when designing interventions) and which contextual factors themselves could be targeted as part of a knowledge translation intervention (context modification). Concept analysis. The Walker and Avant concept analysis method, comprised of eight systematic steps, will be used: (1) concept selection; (2) determination of aims; (3) identification of uses of context; (4) determination of defining attributes of context; (5) identification/construction of a model case of context; (6) identification/construction of additional cases of context; (7) identification/construction of antecedents and consequences of context; and (8) definition of empirical referents of context. This study is funded by the Canadian Institutes of Health Research (January 2014). This study will result in a much needed framework of context for knowledge translation, which identifies specific elements that, if assessed and used to tailor knowledge translation activities, will result in increased research use by nurses and other healthcare professionals in clinical practice, ultimately leading to better patient care. © 2014 John Wiley & Sons Ltd.

  6. The Living Donor Lost Wages Trial: Study Rationale and Protocol.

    Science.gov (United States)

    Rodrigue, James R; Fleishman, Aaron; Carroll, Michaela; Evenson, Amy R; Pavlakis, Martha; Mandelbrot, Didier A; Baliga, Prabhakar; Howard, David H; Schold, Jesse D

    2018-03-01

    This paper describes the background, rationale, and design of an NIH-funded, single-center study to test the impact of offering reimbursement for donor lost wages incurred during the post-nephrectomy recovery period on the live donor kidney transplant (LDKT) rate in newly evaluated kidney transplant candidates, to examine whether offering reimbursement for donor lost wages reduces racial disparity in LDKT rates, and to determine whether higher reimbursement amounts lead to higher LDKT rates. LDKT is the optimal treatment for renal failure. However, living kidney donation has declined in the past decade, particularly among men, younger adults, blacks, and low-income adults. There is evidence that donation-related costs may deter both transplant candidates and potential donors from considering LDKT. Lost wages is a major source of financial loss for some living donors and, unlike travel and lodging expenses, is not reimbursed by financial assistance programs. The study addresses the transplant community's call to reduce the financial burden of living donation and examine its impact on LDKT rates. Findings have the potential to influence policy, clinical practice, LDKT access, and income-related and racial disparities in LDKT and living donation.

  7. Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol.

    Science.gov (United States)

    Simmons, Rebecca G; Shattuck, Dominick C; Jennings, Victoria H

    2017-01-18

    assess pregnancy status over time. This paper outlines the protocol for this efficacy trial, following the Standard Protocol Items: Recommendations for Intervention Trials checklist, to provide an overview of the rationale, methodology, and analysis plan. Participants will be asked to provide daily sexual history data and periodically answer surveys administered through a call center or directly on their phone. Funding for the study was provided in 2013 under the United States Agency for International Development Fertility Awareness for Community Transformation project. Recruitment for the study will begin in January of 2017. The study is expected to last approximately 18 months, depending on recruitment. Findings on the study's primary outcomes are expected to be finalized by September 2018. Reproducibility and transparency, important aspects of all research, are particularly critical in developing new approaches to research design. This protocol outlines the first study to prospectively test both the efficacy (correct use) and effectiveness (actual use) of a pregnancy prevention app. This protocol and the processes it describes reflect the dynamic integration of mobile technologies, a call center, and Health Insurance Portability and Accountability Act-compliant study procedures. Future fertility app studies can build on our approaches to develop methodologies that can contribute to the evidence base around app-based methods of contraception. ClinicalTrials.gov NCT02833922; https://clinicaltrials.gov/ct2/show/NCT02833922 (Archived be WebCite at http://www.webcitation.org/6nDkr0e76). ©Rebecca G Simmons, Dominick C Shattuck, Victoria H Jennings. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.01.2017.

  8. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

  9. Cocoa Polyphenols: Evidence from Epidemiological Studies.

    Science.gov (United States)

    Matsumoto, Chisa

    2018-01-01

    Accumulating evidence suggests potential preventive effects of chocolate/cocoa on the risk of cardio vascular disease (CVD). However, cocoa products also contain high levels of sugar and fat, which increase CVD risk factors. Even, the identity of the substance in chocolate/cocoa that has a favorable effect on CVD and CVD risk factors remains unclear, growing evidence from experimental studies suggests that cocoa polyphenols might be a major contributor to cardiovascular-protective effects. However, epidemiological studies, which are necessary to evaluate an association between the risk of CVD and cocoa polyphenol, remain sparse. We will discuss recent evidence regarding the association between cocoa polyphenol consumption and the risks of CVD and its risk factors by reviewing recent epidemiological studies. We shall also provide some guidance for patient counseling and will discuss the public health implications for recommending cocoa polyphenol consumption to prevent CVD. Epidemiological studies evaluating the association between cocoa polyphenol itself and the risk of CVD are sparse. However, evidence from limited epidemiological studies suggests that cocoa polyphenol consumption may lower the risk of CVD. Given the potential adverse effects of the consumption of cocoa products with high fat and sugar and the fact that the most appropriate dose of cocoa polyphenol for cardio-protective effects has not yet been established, health care providers should remain cautious about recommending cocoa/cocoa polyphenol consumption to their patients to reduce the risk of CVD, taking the characteristics of individual patients into careful consideration. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  10. A Comparative Study of Wireless Sensor Networks and Their Routing Protocols

    Directory of Open Access Journals (Sweden)

    Subhajit Pal

    2010-11-01

    Full Text Available Recent developments in the area of micro-sensor devices have accelerated advances in the sensor networks field leading to many new protocols specifically designed for wireless sensor networks (WSNs. Wireless sensor networks with hundreds to thousands of sensor nodes can gather information from an unattended location and transmit the gathered data to a particular user, depending on the application. These sensor nodes have some constraints due to their limited energy, storage capacity and computing power. Data are routed from one node to other using different routing protocols. There are a number of routing protocols for wireless sensor networks. In this review article, we discuss the architecture of wireless sensor networks. Further, we categorize the routing protocols according to some key factors and summarize their mode of operation. Finally, we provide a comparative study on these various protocols.

  11. Mecasin treatment in patients with amyotrophic lateral sclerosis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kim, Sungha; Kim, Jae Kyoun; Son, Mi Ju; Kim, Dongwoung; Song, Bongkeun; Son, Ilhong; Kang, Hyung Won; Lee, Jongdeok; Kim, Sungchul

    2018-04-13

    Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that causes paralysis of limb, swallowing, and breathing muscles. Riluzole, the Food and Drug Administration-approved drug for ALS, provides minimal benefit, prolonging patient life by only 2-3 months. Previous studies have found a neuro-protective and anti-neuroinflammatory effect of Mecasin, with retrospective studies providing suggestive evidence for a beneficial effect of Mecasin. The aim of this study was to develop a protocol to determine the proper dosage of Mecasin. This is a phase II-A, multi-center, randomized study with three arms. Thirty-six patients with ALS will be randomly assigned to one of three groups, each receiving the standard treatment with 100 mg of riluzole in addition to one of 1.6 g of Mecasin, 2.4 g of Mecasin, or a placebo. The Primary outcome is the Korean version of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised result after 12 weeks of treatment. Secondary outcomes include results of the Short Form Health Survey-8, Medical Research Council Scale, Visual Analogue Scale for Pain, Hamilton Rating Scale for Depression, Fatigue Severity Scale, Patient Global Impression of Change, pulmonary function test, forced expiratory volume in 1 s and its ratio to forced vital capacity, creatine kinase, and body weight. The frequencies of total adverse events and serious adverse events will be described and documented. The trial protocol has been approved by the Institutional Review Board of the Wonkwang University Gwangju and Sanbon Hospital (2016-5-4 and 2016-34-01, respectively). An Investigational New Drug status (30731) was granted by the Korea Food and Drug Administration. This trial will aim to identify the optimal dosage of Mecasin. Additionally, it will test the efficacy and safety of Mecasin in conjunction with standard treatment, riluzole, for alleviating the functional decline in patients with ALS. Korean National Clinical Trial Registry CRIS; KCT

  12. 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

  13. A Guide to Writing a Qualitative Systematic Review Protocol to Enhance Evidence-Based Practice in Nursing and Health Care.

    Science.gov (United States)

    Butler, Ashleigh; Hall, Helen; Copnell, Beverley

    2016-06-01

    The qualitative systematic review is a rapidly developing area of nursing research. In order to present trustworthy, high-quality recommendations, such reviews should be based on a review protocol to minimize bias and enhance transparency and reproducibility. Although there are a number of resources available to guide researchers in developing a quantitative review protocol, very few resources exist for qualitative reviews. To guide researchers through the process of developing a qualitative systematic review protocol, using an example review question. The key elements required in a systematic review protocol are discussed, with a focus on application to qualitative reviews: Development of a research question; formulation of key search terms and strategies; designing a multistage review process; critical appraisal of qualitative literature; development of data extraction techniques; and data synthesis. The paper highlights important considerations during the protocol development process, and uses a previously developed review question as a working example. This paper will assist novice researchers in developing a qualitative systematic review protocol. By providing a worked example of a protocol, the paper encourages the development of review protocols, enhancing the trustworthiness and value of the completed qualitative systematic review findings. Qualitative systematic reviews should be based on well planned, peer reviewed protocols to enhance the trustworthiness of results and thus their usefulness in clinical practice. Protocols should outline, in detail, the processes which will be used to undertake the review, including key search terms, inclusion and exclusion criteria, and the methods used for critical appraisal, data extraction and data analysis to facilitate transparency of the review process. Additionally, journals should encourage and support the publication of review protocols, and should require reference to a protocol prior to publication of the

  14. A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial.

    Science.gov (United States)

    Swindle, Taren; Johnson, Susan L; Whiteside-Mansell, Leanne; Curran, Geoffrey M

    2017-07-18

    Despite the potential to reach at-risk children in childcare, there is a significant gap between current practices and evidence-based obesity prevention in this setting. There are few investigations of the impact of implementation strategies on the uptake of evidence-based practices (EBPs) for obesity prevention and nutrition promotion. This study protocol describes a three-phase approach to developing and testing implementation strategies to support uptake of EBPs for obesity prevention practices in childcare (i.e., key components of the WISE intervention). Informed by the i-PARIHS framework, we will use a stakeholder-driven evidence-based quality improvement (EBQI) process to apply information gathered in qualitative interviews on barriers and facilitators to practice to inform the design of implementation strategies. Then, a Hybrid Type III cluster randomized trial will compare a basic implementation strategy (i.e., intervention as usual) with an enhanced implementation strategy informed by stakeholders. All Head Start centers (N = 12) within one agency in an urban area in a southern state in the USA will be randomized to receive the basic or enhanced implementation with approximately 20 classrooms per group (40 educators, 400 children per group). The educators involved in the study, the data collectors, and the biostastician will be blinded to the study condition. The basic and enhanced implementation strategies will be compared on outcomes specified by the RE-AIM model (e.g., Reach to families, Effectiveness of impact on child diet and health indicators, Adoption commitment of agency, Implementation fidelity and acceptability, and Maintenance after 6 months). Principles of formative evaluation will be used throughout the hybrid trial. This study will test a stakeholder-driven approach to improve implementation, fidelity, and maintenance of EBPs for obesity prevention in childcare. Further, this study provides an example of a systematic process to develop

  15. Switching From Age-Based Stimulus Dosing to Dose Titration Protocols in Electroconvulsive Therapy: Empirical Evidence for Better Patient Outcomes With Lower Peak and Cumulative Energy Doses.

    Science.gov (United States)

    O'Neill-Kerr, Alex; Yassin, Anhar; Rogers, Stephen; Cornish, Janie

    2017-09-01

    The aim of this study was to test the proposition that adoption of a dose titration protocol may be associated with better patient outcomes, at lower treatment dose, and with comparable cumulative dose to that in patients treated using an age-based stimulus dosing protocol. This was an analysis of data assembled from archived records and based on cohorts of patients treated respectively on an age-based stimulus dosing protocol and on a dose titration protocol in the National Health Service in England. We demonstrated a significantly better response in the patient cohort treated with dose titration than with age-based stimulus dosing. Peak doses were less and the total cumulative dose was less in the dose titration group than in the age-based stimulus dosing group. Our findings are consistent with superior outcomes in patients treated using a dose titration protocol when compared with age-based stimulus dosing in a similar cohort of patients.

  16. Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence.

    Science.gov (United States)

    Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

    2017-08-18

    Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in 'patient safety' and 'economic analyses' has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer

  17. Exploring facilitating factors and barriers to the nationwide dissemination of a Dutch school-based obesity prevention program "DOiT": a study protocol

    NARCIS (Netherlands)

    van Nassau, F.; Singh, A.S.; van Mechelen, W.; Paulussen, T.G.; Brug, J.; Chinapaw, M.J.

    2013-01-01

    Background: The evidence-based Dutch Obesity Intervention in Teenagers (DOiT) program is a school-based obesity prevention program for 12 to 14-year olds attending the first two years of prevocational education. This paper describes the study protocol applied to evaluate (a) the nationwide

  18. Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya

    DEFF Research Database (Denmark)

    Bailey, Jeanette; Lelijveld, Natasha; Marron, Bethany

    2018-01-01

    Background: Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The Combined Protocol for Acute Malnutrition Study (ComPAS) aims to simplify and unify...... the treatment of uncomplicated severe and moderate acute malnutrition (SAM and MAM) for children 6-59 months into one protocol in order to improve the global coverage, quality, continuity of care and cost-effectiveness of acute malnutrition treatment in resource-constrained settings.  Methods/design: This study...... is a multi-site, cluster randomized non-inferiority trial with 12 clusters in Kenya and 12 clusters in South Sudan. Participants are 3600 children aged 6-59 months with uncomplicated acute malnutrition. This study will evaluate the impact of a simplified and combined protocol for the treatment of SAM and MAM...

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

    Science.gov (United States)

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

    2018-04-19

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

  20. Cryotherapy for acute ankle sprains: a randomised controlled study of two different icing protocols.

    Science.gov (United States)

    Bleakley, C M; McDonough, S M; MacAuley, D C; Bjordal, J

    2006-08-01

    The use of cryotherapy in the management of acute soft tissue injury is largely based on anecdotal evidence. Preliminary evidence suggests that intermittent cryotherapy applications are most effective at reducing tissue temperature to optimal therapeutic levels. However, its efficacy in treating injured human subjects is not yet known. To compare the efficacy of an intermittent cryotherapy treatment protocol with a standard cryotherapy treatment protocol in the management of acute ankle sprains. Sportsmen (n = 44) and members of the general public (n = 45) with mild/moderate acute ankle sprains. Subjects were randomly allocated, under strictly controlled double blind conditions, to one of two treatment groups: standard ice application (n = 46) or intermittent ice application (n = 43). The mode of cryotherapy was standardised across groups and consisted of melting iced water (0 degrees C) in a standardised pack. Function, pain, and swelling were recorded at baseline and one, two, three, four, and six weeks after injury. Subjects treated with the intermittent protocol had significantly (p<0.05) less ankle pain on activity than those using a standard 20 minute protocol; however, one week after ankle injury, there were no significant differences between groups in terms of function, swelling, or pain at rest. Intermittent applications may enhance the therapeutic effect of ice in pain relief after acute soft tissue injury.

  1. Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol.

    Science.gov (United States)

    Röösli, Martin; Frei, Patrizia; Bolte, John; Neubauer, Georg; Cardis, Elisabeth; Feychting, Maria; Gajsek, Peter; Heinrich, Sabine; Joseph, Wout; Mann, Simon; Martens, Luc; Mohler, Evelyn; Parslow, Roger C; Poulsen, Aslak Harbo; Radon, Katja; Schüz, Joachim; Thuroczy, György; Viel, Jean-François; Vrijheid, Martine

    2010-05-20

    The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF) is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas.

  2. Design, rationale and feasibility of a multidimensional experimental protocol to study early life stress

    Directory of Open Access Journals (Sweden)

    M. Dillwyn Bartholomeusz

    2017-09-01

    Full Text Available There is a rapidly accumulating body of evidence regarding the influential role of early life stress (ELS upon medical and psychiatric conditions. While self-report instruments, with their intrinsic limitations of recall, remain the primary means of detecting ELS in humans, biological measures are generally limited to a single biological system. This paper describes the design, rationale and feasibility of a study to simultaneously measure neuroendocrine, immune and autonomic nervous system (ANS responses to psychological and physiological stressors in relation to ELS. Five healthy university students were recruited by advertisement. Exclusion criteria included chronic medical conditions, psychotic disorders, needle phobia, inability to tolerate pain, and those using anti-inflammatory medications. They were clinically interviewed and physiological recordings made over a two-hour period pre, during and post two acute stressors: the cold pressor test and recalling a distressing memory. The Childhood Trauma Questionnaire and the Parental Bonding Index were utilised to measure ELS. Other psychological measures of mood and personality were also administered. Measurements of heart rate, blood pressure, respiratory rate, skin conductance, skin blood flow and temporal plasma samples were successfully obtained before, during and after acute stress. Participants reported the extensive psychological and multisystem physiological data collection and stress provocations were tolerable. Most (4/5 participants indicated a willingness to return to repeat the protocol, indicating acceptability. Our protocol is viable and safe in young physically healthy adults and allows us to assess simultaneously neuroendocrine, immune and autonomic nervous system responses to stressors in persons assessed for ELS. Keywords: Childhood-stress, Adverse-childhood-events, Childhood-trauma questionnaire, Parental-bonding-instrument, Type D scale (DS14

  3. Wayfinding in ageing and Alzheimer's disease within a virtual senior residence: study protocol.

    Science.gov (United States)

    Davis, Rebecca; Ohman, Jennifer

    2016-07-01

    To report a study protocol that examines the impact of adding salient cues in a virtual reality simulation of a senior residential building on wayfinding for older adults with and without Alzheimer's disease. An early symptom of Alzheimer's disease is the inability to find one's way (wayfinding). Senior residential environments are especially difficult for wayfinding. Salient cues may be able to help persons with Alzheimer's disease find their way more effectively so they can maintain independence. A repeated measures, within and between subjects design. This study was funded by the National Institutes of Health (August 2012). Older adults (N = 40) with normal cognition and older adults with early stage Alzheimer's disease/mild cognitive impairment (N = 40) will try to find their way to a location repeatedly in a virtual reality simulation of senior residence. There are two environments: standard (no cues) and salient (multiple cues). Outcome measures include how often and how quickly participants find the target location in each cue condition. The results of this study have the potential to provide evidence for ways to make the environment more supportive for wayfinding for older adults with Alzheimer's disease. This study is registered at Trialmatch.alz.org (Identifier 260425-5). © 2016 John Wiley & Sons Ltd.

  4. Preclinical experimental stress studies: protocols, assessment and comparison.

    Science.gov (United States)

    Bali, Anjana; Jaggi, Amteshwar Singh

    2015-01-05

    Stress is a state of threatened homeostasis during which a variety of adaptive processes are activated to produce physiological and behavioral changes. Preclinical models are pivotal for understanding these physiological or pathophysiological changes in the body in response to stress. Furthermore, these models are also important for the development of novel pharmacological agents for stress management. The well described preclinical stress models include immobilization, restraint, electric foot shock and social isolation stress. Stress assessment in animals is done at the behavioral level using open field, social interaction, hole board test; at the biochemical level by measuring plasma corticosterone and ACTH; at the physiological level by measuring food intake, body weight, adrenal gland weight and gastric ulceration. Furthermore the comparison between different stressors including electric foot shock, immobilization and cold stressor is described in terms of intensity, hormonal release, protein changes in brain, adaptation and sleep pattern. This present review describes these preclinical stress protocols, and stress assessment at different levels. Copyright © 2014 Elsevier B.V. All rights reserved.

  5. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; 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; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  6. 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 Ca, Fe, K, Mg, Na, S, Ti, Ag, As, Ba, Be, Bi, Cd, Ce, Co, Cr, Cs, Cu, Ga, In, La, Li, Mn, Mo, Nb, Ni, P, Pb, Rb, Sb, Sc, Sn, Sr, Te, Th, Tl, U, V, W, Y, and Zn by inductively coupled plasma-mass spectrometry and inductively coupled plasma-atomic emission spectrometry following a near-total digestion in a mixture of HCl, HNO3, 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

  7. Comparing a Mobile Decision Support System Versus the Use of Printed Materials for the Implementation of an Evidence-Based Recommendation: Protocol for a Qualitative Evaluation.

    Science.gov (United States)

    Camacho, Jhon; Medina Ch, Ana María; Landis-Lewis, Zach; Douglas, Gerald; Boyce, Richard

    2018-04-13

    The distribution of printed materials is the most frequently used strategy to disseminate and implement clinical practice guidelines, although several studies have shown that the effectiveness of this approach is modest at best. Nevertheless, there is insufficient evidence to support the use of other strategies. Recent research has shown that the use of computerized decision support presents a promising approach to address some aspects of this problem. The aim of this study is to provide qualitative evidence on the potential effect of mobile decision support systems to facilitate the implementation of evidence-based recommendations included in clinical practice guidelines. We will conduct a qualitative study with two arms to compare the experience of primary care physicians while they try to implement an evidence-based recommendation in their clinical practice. In the first arm, we will provide participants with a printout of the guideline article containing the recommendation, while in the second arm, we will provide participants with a mobile app developed after formalizing the recommendation text into a clinical algorithm. Data will be collected using semistructured and open interviews to explore aspects of behavioral change and technology acceptance involved in the implementation process. The analysis will be comprised of two phases. During the first phase, we will conduct a template analysis to identify barriers and facilitators in each scenario. Then, during the second phase, we will contrast the findings from each arm to propose hypotheses about the potential impact of the system. We have formalized the narrative in the recommendation into a clinical algorithm and have developed a mobile app. Data collection is expected to occur during 2018, with the first phase of analysis running in parallel. The second phase is scheduled to conclude in July 2019. Our study will further the understanding of the role of mobile decision support systems in the implementation

  8. Student and educator experiences of maternal-child simulation-based learning: a systematic review of qualitative evidence protocol.

    Science.gov (United States)

    MacKinnon, Karen; Marcellus, Lenora; Rivers, Julie; Gordon, Carol; Ryan, Maureen; Butcher, Diane

    2015-01-01

    , enhancing nurses' abilities to build upon previous knowledge and past experiences, and manage new or unfamiliar situations.Simulation has previously been integrated into nursing curricula in a "piecemeal" fashion that lacks an integrative pedagogy or theoretical approach. More recently a number of theoretical and pedagogical frameworks and best practice standards have been published. In April 2014 a preliminary search of literature (in CINAHL, Medline, Academic Search Complete and Web of Science) was conducted with guidance from our library specialist to test the search strategy and ensure that there would be enough qualitative findings to include in the systematic review. A preliminary scan of the abstracts from these searches demonstrated that many experiential case reports with qualitative findings were missed with the use of research limiters (including our search strategy specifically constructed to retrieve qualitative research) so the decision was made to err on the side of caution by searching more broadly and review a larger number of abstracts for inclusion in the study. However, a number of reports with qualitative findings were identified. For example, from a review of the abstracts from a CINAHL search dated April 17, qualitative research papers (including two dissertations), 12 evaluation study reports, six mixed methods studies and nine case reports with qualitative findings were identified. It is timely then to review qualitative studies to better understand the meaningfulness and appropriateness of integrating maternal-child simulation-based learning activities in undergraduate nursing education programs.A search of both the Cochrane Library of Systematic Reviews and the Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports has been conducted. No systematic reviews of qualitative studies of maternal-child simulation-based learning for undergraduate or pre-registration nursing students in educational settings are evident in the

  9. Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Narita, Zui; Yokoi, Yuma

    2017-06-19

    Patients with Alzheimer's disease frequently elicit neuropsychiatric symptoms as well as cognitive deficits. Above all, depression is one of the most common neuropsychiatric symptoms in Alzheimer's disease but antidepressant drugs have not shown significant beneficial effects on it. Moreover, electroconvulsive therapy has not ensured its safety for potential severe adverse events although it does show beneficial clinical effect. Transcranial direct current stimulation can be the safe alternative of neuromodulation, which applies weak direct electrical current to the brain. Although transcranial direct current stimulation has plausible evidence for its effect on depression in young adult patients, no study has explored it in older subjects with depression in Alzheimer's disease. Therefore, we present a study protocol designed to evaluate the safety and clinical effect of transcranial direct current stimulation on depression in Alzheimer's disease in subjects aged over 65 years. This is a two-arm, parallel-design, randomized controlled trial, in which patients and assessors will be blinded. Subjects will be randomized to either an active or a sham transcranial direct current stimulation group. Participants in both groups will be evaluated at baseline, immediately, and 2 weeks after the intervention. This study investigates the safety and effect of transcranial direct current stimulation that may bring a significant impact on both depression and cognition in patients with Alzheimer's disease, and may be useful to enhance their quality of life. ClinicalTrials.gov, NCT02351388 . Registered on 27 January 2015. Last updated on 30 May 2016.

  10. Towards a standardised approach for evaluating guidelines and guidance documents on palliative sedation: study protocol.

    Science.gov (United States)

    Abarshi, Ebun; Rietjens, Judith; Caraceni, Augusto; Payne, Sheila; Deliens, Luc; Van Den Block, Lieve

    2014-01-01

    Sedation in palliative care has received growing attention in recent years; and so have guidelines, position statements, and related literature that provide recommendations for its practice. Yet little is known collectively about the content, scope and methodological quality of these materials. According to research, there are large variations in palliative sedation practice, depending on the definition and methodology used. However, a standardised approach to comparing and contrasting related documents, across countries, associations and governmental bodies is lacking. This paper reports on a protocol designed to enable thorough and systematic comparison of guidelines and guidance documents on palliative sedation. A multidisciplinary and international group of palliative care researchers, identified themes and clinical issues on palliative sedation based on expert consultations and evidence drawn from the EAPC (European Association of Palliative Care) framework for palliative sedation and AGREE II (Appraisal Guideline Research and Evaluation) instrument for guideline assessment. The most relevant themes were selected and built into a comprehensive checklist. This was tested on people working closely with practitioners and patients, for user-friendliness and comprehensibility, and modified where necessary. Next, a systematic search was conducted for guidelines in English, Dutch, Flemish, or Italian. The search was performed in multiple databases (PubMed, CancerLit, CNAHL, Cochrane Library, NHS Evidence and Google Scholar), and via other Internet resources. Hereafter, the final version of the checklist will be used to extract data from selected literature, and the same will be compiled, entered into SPSS, cleaned and analysed systematically for publication. We have together developed a comprehensive checklist in a scientifically rigorous manner to allow standardised and systematic comparison. The protocol is applicable to all guidelines on palliative sedation, and

  11. Danish method study on cervical screening in women offered HPV vaccination as girls (Trial23): a study protocol.

    Science.gov (United States)

    Thamsborg, Lise Holst; Andersen, Berit; Larsen, Lise Grupe; Christensen, Jette; Johansen, Tonje; Hariri, Jalil; Christiansen, Sanne; Rygaard, Carsten; Lynge, Elsebeth

    2018-05-26

    The first birth cohorts of women offered human papillomavirus (HPV) vaccination as girls are now entering cervical screening. However, there is no international consensus on how to screen HPV vaccinated women. These women are better protected against cervical cancer and could therefore be offered less intensive screening. Primary HPV testing is more sensitive than cytology, allowing for a longer screening interval. The aim of Trial23 is to investigate if primary HPV testing with cytology triage of HPV positive samples is a reasonable screening scheme for women offered HPV vaccination as girls. Trial23 is a method study embedded in the existing cervical screening programme in four out of five Danish regions. Without affecting the screening programme, women born in 1994 are randomised to present screening with liquid-based cytology every third year (present programme arm) or present screening plus an HPV test (HPV arm). The study started 1 February 2017 and will run over three screening rounds corresponding to 7-8 years. The primary endpoint is cervical intraepithelial neoplasia grade 3 or above. The trial is undertaken as a non-inferiority study including intention-to-treat and per-protocol analyses. The potential effect of primary HPV screening with a 6-year interval will be calculated from the observed data. The study protocol has been submitted to the ethical committee and deemed a method study. All women are screened according to routine guidelines. The study will contribute new evidence on the future screening of HPV vaccinated birth cohorts of women. All results will be published in open-access journal. NCT03049553; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial.

    Science.gov (United States)

    Shin, Seungwon; Lee, Jiwon; Yoo, Junghee; Lim, Sung Min; Lee, Euiju

    2016-04-12

    This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control. A multicenter, blinded, randomized controlled trial will be conducted in three hospitals in the Republic of Korea. We are recruiting 54 stroke survivors (aged >19 years), who were diagnosed with urinary retention based on the results of two consecutive post-void residual (PVR) tests, and dividing them randomly into two arms: the EA and Park-sham control groups. They will receive ten sessions of EA or sham treatment for 2 weeks. The participants will be blinded with non-penetrating needles and fake sounds of EA stimulators. The daily PVR ratio will be primarily measured at baseline and at the end of the study to statistically test the effectiveness of EA for poststroke urinary retention. Then, the Korean version of the Qualiveen Questionnaire, the Korean version of the International Prostate Symptom Score, and the blinding index will be assessed. After each EA session or sham EA, adverse events will be reported to evaluate the safety of EA. Results will be analyzed by using the independent t-test or Mann-Whitney U test, based on both intention-to-treat and per-protocol principles. The findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors. This study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.

  13. Documenting research with transgender and gender diverse people: protocol for an evidence map and thematic analysis

    Directory of Open Access Journals (Sweden)

    Zack Marshall

    2017-02-01

    Full Text Available Abstract Background There is limited information about how transgender, gender diverse, and Two-Spirit (trans people have been represented and studied by researchers. The objectives of this study are to (1 map and describe trans research in the social sciences, sciences, humanities, health, education, and business, (2 identify evidence gaps and opportunities for more responsible research with trans people, (3 assess the use of text mining for study identification, and (4 increase access to trans research for key stakeholders through the creation of a web-based evidence map. Methods Study design was informed by community consultations and pilot searches. Eligibility criteria were established to include all original research of any design, including trans people or their health information, and published in English in peer-reviewed journals. A complex electronic search strategy based on relevant concepts in 15 databases was developed to obtain a broad range of results linked to transgender, gender diverse, and Two-Spirit individuals and communities. Searches conducted in early 2015 resulted in 25,242 references after removal of duplicates. Based on the number of references, resources, and an objective to capture upwards of 90% of the existing literature, this study is a good candidate for text mining using Latent Dirichlet Allocation to improve efficiency of the screening process. The following information will be collected for evidence mapping: study topic, study design, methods and data sources, recruitment strategies, sample size, sample demographics, researcher name and affiliation, country where research was conducted, funding source, and year of publication. Discussion The proposed research incorporates an extensive search strategy, text mining, and evidence map; it therefore has the potential to build on knowledge in several fields. Review results will increase awareness of existing trans research, identify evidence gaps, and inform

  14. 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

  15. The Oxford Participation and Activities Questionnaire: study protocol.

    Science.gov (United States)

    Morley, David; Dummett, Sarah; Kelly, Laura; Dawson, Jill; Fitzpatrick, Ray; Jenkinson, Crispin

    2013-01-01

    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. 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 identify appropriate dimensions and redundant items. Reliability will be assessed by Cronbach's alpha and item-total correlations. A second, large-scale postal survey will follow, with the Ox-PAQ being

  16. Comparing ultraviolet light A photo(chemo)therapy with Methotrexate protocol in childhood localized scleroderma: Evidence from systematic review and meta-analysis approach.

    Science.gov (United States)

    Marrani, Edoardo; Foeldvari, Ivan; Lopez, Jordi Anton; Cimaz, Rolando; Simonini, Gabriele

    2018-03-14

    Localized scleroderma is a skin fibrosing disorder that, if untreated, may result in severe disability. The purpose of this systematic review is to compare the present evidence concerning the effectiveness of Methotrexate versus phototherapy, alone or associated with Psoralen, in childhood localized scleroderma. A systematic search between January 1996 and May 2017 was performed to identify studies investigating the efficacy of Methotrexate (MTX) or phototherapy (UVA) for treating localized scleroderma with onset ≤18 years. Due to a lack of validated clinical criteria, four clinical response criteria were used to assess the treatment efficacy as primary outcome. We determined a combined estimate of the proportion of children responding to MTX and UVA. A total of 19 studies was included (8 MTX; 11 UVA). In the methotrexate group, 193 children were included in the analysis; in the phototherapy group, a total of 48 treated children. For both groups age, disease subtype, glucocorticoids (GCs) use, and side effects of treatment were also analyzed. The meta-analysis suggested that UVA and MTX protocols have both a favorable effect in active lesions of childhood localized scleroderma. However, MTX resulted significantly superior to UVA, with or without Psoralen. Our study supports the combination of MTX and GCs in patients with a high risk of complication. Phototherapy with UVA1 could represent a therapeutic option in patients with limited scleroderma, where lesions do not cross joints and they do not lead to potential cosmetic changes. Copyright © 2018 Elsevier Inc. All rights reserved.

  17. Cochrane Qualitative and Implementation Methods Group guidance series-paper 2: methods for question formulation, searching, and protocol development for qualitative evidence synthesis.

    Science.gov (United States)

    Harris, Janet L; Booth, Andrew; Cargo, Margaret; Hannes, Karin; Harden, Angela; Flemming, Kate; Garside, Ruth; Pantoja, Tomas; Thomas, James; Noyes, Jane

    2018-05-01

    This paper updates previous Cochrane guidance on question formulation, searching, and protocol development, reflecting recent developments in methods for conducting qualitative evidence syntheses to inform Cochrane intervention reviews. Examples are used to illustrate how decisions about boundaries for a review are formed via an iterative process of constructing lines of inquiry and mapping the available information to ascertain whether evidence exists to answer questions related to effectiveness, implementation, feasibility, appropriateness, economic evidence, and equity. The process of question formulation allows reviewers to situate the topic in relation to how it informs and explains effectiveness, using the criterion of meaningfulness, appropriateness, feasibility, and implementation. Questions related to complex questions and interventions can be structured by drawing on an increasingly wide range of question frameworks. Logic models and theoretical frameworks are useful tools for conceptually mapping the literature to illustrate the complexity of the phenomenon of interest. Furthermore, protocol development may require iterative question formulation and searching. Consequently, the final protocol may function as a guide rather than a prescriptive route map, particularly in qualitative reviews that ask more exploratory and open-ended questions. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Short and long-term effectiveness of couple counselling: a study protocol

    Directory of Open Access Journals (Sweden)

    Schofield Margot J

    2012-09-01

    Full Text Available Abstract Background Healthy couple relationships are fundamental to a healthy society, whereas relationship breakdown and discord are linked to a wide range of negative health and wellbeing outcomes. Two types of relationship services (couple counselling and relationship education have demonstrated efficacy in many controlled studies but evidence of the effectiveness of community-based relationship services has lagged behind. This study protocol describes an effectiveness evaluation of the two types of community-based relationship services. The aims of the Evaluation of Couple Counselling study are to: map the profiles of clients seeking agency-based couple counselling and relationship enhancement programs in terms of socio-demographic, relationship, health, and health service use indicators; to determine 3 and 12-month outcomes for relationship satisfaction, commitment, and depression; and determine relative contributions of client and therapy factors to outcomes. Methods/Design A quasi-experimental pre-post-post evaluation design is used to assess outcomes for couples presenting for the two types of community-based relationship services. The longitudinal design involves a pre-treatment survey and two follow-up surveys at 3- and 12-months post-intervention. The study is set in eight Relationships Australia Victoria centres, across metropolitan, outer suburbs, and regional/rural sites. Relationships Australia, a non-government organisation, is the largest provider of couple counselling and relationship services in Australia. The key outcomes are couple satisfaction, relationship commitment, and depression measured by the CESD-10. Multi-level modelling will be used to account for the dyadic nature of couple data. Discussion The study protocol describes the first large scale investigation of the effectiveness of two types of relationship services to be conducted in Australia. Its significance lies in providing more detailed profiles of couples who

  19. Study protocol: mobile improvement of self-management ability through rural technology (mI SMART).

    Science.gov (United States)

    Mallow, Jennifer A; Theeke, Laurie A; Long, Dustin M; Whetsel, Tara; Theeke, Elliott; Mallow, Brian K

    2015-01-01

    There are 62 million Americans currently residing in rural areas who are more likely to have multiple chronic conditions and be economically disadvantaged, and in poor health, receive less recommended preventive services and attend fewer visits to health care providers. Recent advances in mobile healthcare (mHealth) offer a promising new approach to solving health disparities and improving chronic illness care. It is now possible and affordable to transmit health information, including values from glucometers, automated blood pressure monitors, and scales, through Bluetooth-enabled devices. Additionally, audio and video communications technologies can allow healthcare providers to conduct many parts of a physical exam remotely from varied settings. These technologies could remove geographical distance as a barrier to care and diminish the access to care issues faced by patients who live rurally. However, currently there is lack of studies that provide evidence of feasibility, acceptability, and effectiveness of mHealth initiatives on improved outcomes of care, a needed step to make the translation to implementation studies in healthcare systems. The purpose of this paper is to present the protocol for the first study of mI SMART (mobile Improvement of Self-Management Ability through Rural Technology), a new integrated mHealth intervention. Our objective is to provide evidence of feasibility and acceptability for the use of mI SMART in an underserved population and establish evidence for the refinement of mI SMART. The proposed study will take place at Milan Puskar Health Right, a free primary care clinic in the state of West Virginia. The clinic provides health care at no cost to uninsured, low income; adults aged 18-64 living in West Virginia. We will enroll 30 participants into this feasibility study with plans of implementing a longitudinal randomized, comparative effectiveness design in the future. Data collection will include tracking of barriers and

  20. Consumer preferences for sustainable aquaculture products: Evidence from in-depth interviews, think aloud protocols and choice experiments.

    Science.gov (United States)

    Risius, Antje; Janssen, Meike; Hamm, Ulrich

    2017-06-01

    Fish from aquaculture is becoming more important for human consumption. Sustainable aquaculture procedures were developed as an alternative to overcome the negative environmental impacts of conventional aquaculture procedures and wild fisheries. The objective of this contribution is to determine what consumers expect from sustainable aquaculture and whether they prefer sustainable aquaculture products. A combination of qualitative research methods, with think aloud protocols and in-depth interviews, as well as quantitative methods, using choice experiments and face-to-face interviews, was applied. Data was collected in three different cities of Germany. Results revealed that sustainable aquaculture was associated with natural, traditional, local, and small scale production systems with high animal welfare standards. Overall, participants paid a lot of attention to the declaration of origin; in particular fish products from Germany and Denmark were preferred along with local products. Frequently used sustainability claims for aquaculture products were mostly criticized as being imprecise by the participants of the qualitative study; even though two claims tested in the choice experiments had a significant positive impact on the choice of purchase. Similarly, existing aquaculture-specific labels for certified sustainable aquaculture had an impact on the buying decision, but were not well recognized and even less trusted. Overall, consumers had a positive attitude towards sustainable aquaculture. However, communication measures and labelling schemes should be improved to increase consumer acceptance and make a decisive impact on consumers' buying behavior. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Effective protein extraction protocol for proteomics studies of Jerusalem artichoke leaves.

    Science.gov (United States)

    Zhang, Meide; Shen, Shihua

    2013-07-01

    Protein extraction is a crucial step for proteomics studies. To establish an effective protein extraction protocol suitable for two-dimensional electrophoresis (2DE) analysis in Jerusalem artichoke (Helianthus tuberosus L.), three different protein extraction methods-trichloroacetic acid/acetone, Mg/NP-40, and phenol/ammonium acetate-were evaluated using Jerusalem artichoke leaves as source materials. Of the three methods, trichloroacetic acid/acetone yielded the best protein separation pattern and highest number of protein spots in 2DE analysis. Proteins highly abundant in leaves, such as Rubisco, are typically problematic during leaf 2DE analysis, however, and this disadvantage was evident using trichloroacetic acid/acetone. To reduce the influence of abundant proteins on the detection of low-abundance proteins, we optimized the trichloroacetic acid/acetone method by incorporating a PEG fractionation approach. After optimization, 363 additional (36.2%) protein spots were detected on the 2DE gel. Our results suggest that trichloroacetic acid/acetone method is a better protein extraction technique than Mg/NP-40 and phenol/ammonium acetate in Jerusalem artichoke leaf 2DE analysis, and that trichloroacetic acid/acetone method combined with PEG fractionation procedure is the most effective approach for leaf 2DE analysis of Jerusalem artichoke. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  2. Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol

    Directory of Open Access Journals (Sweden)

    Radon Katja

    2010-05-01

    Full Text Available Abstract Background The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. Methods The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. Results We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Conclusion Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas.

  3. The implementation and evaluation of an evidence-based statewide prehospital pain management protocol developed using the national prehospital evidence-based guideline model process for emergency medical services.

    Science.gov (United States)

    Brown, Kathleen M; Hirshon, Jon Mark; Alcorta, Richard; Weik, Tasmeen S; Lawner, Ben; Ho, Shiu; Wright, Joseph L

    2014-01-01

    In 2008, the National Highway Traffic Safety Administration funded the development of a model process for the development and implementation of evidence-based guidelines (EBGs) for emergency medical services (EMS). We report on the implementation and evaluation of an evidence-based prehospital pain management protocol developed using this model process. An evidence-based protocol for prehospital management of pain resulting from injuries and burns was reviewed by the Protocol Review Committee (PRC) of the Maryland Institute for Emergency Medical Services Systems (MIEMSS). The PRC recommended revisions to the Maryland protocol that reflected recommendations in the EBG: weight-based dosing and repeat dosing of morphine. A training curriculum was developed and implemented using Maryland's online Learning Management System and successfully accessed by 3,941 paramedics and 15,969 BLS providers. Field providers submitted electronic patient care reports to the MIEMSS statewide prehospital database. Inclusion criteria were injured or burned patients transported by Maryland ambulances to Maryland hospitals whose electronic patient care records included data for level of EMS provider training during a 12-month preimplementation period and a 12-month postimplementation period from September 2010 through March 2012. We compared the percentage of patients receiving pain scale assessments and morphine, as well as the dose of morphine administered and the use of naloxone as a rescue medication for opiate use, before and after the protocol change. No differences were seen in the percentage of patients who had a pain score documented or the percent of patients receiving morphine before and after the protocol change, but there was a significant increase in the total dose and dose in mg/kg administered per patient. During the postintervention phase, patients received an 18% higher total morphine dose and a 14.9% greater mg/kg dose. We demonstrated that the implementation of a revised

  4. Everything should be as simple as possible, but no simpler: towards a protocol for accumulating evidence regarding the active content of health behaviour change interventions.

    Science.gov (United States)

    Peters, Gjalt-Jorn Ygram; de Bruin, Marijn; Crutzen, Rik

    2015-01-01

    There is a need to consolidate the evidence base underlying our toolbox of methods of behaviour change. Recent efforts to this effect have conducted meta-regressions on evaluations of behaviour change interventions, deriving each method's effectiveness from its association to intervention effect size. However, there are a range of issues that raise concern about whether this approach is actually furthering or instead obstructing the advancement of health psychology theories and the quality of health behaviour change interventions. Using examples from theory, the literature and data from previous meta-analyses, these concerns and their implications are explained and illustrated. An iterative protocol for evidence base accumulation is proposed that integrates evidence derived from both experimental and applied behaviour change research, and combines theory development in experimental settings with theory testing in applied real-life settings. As evidence gathered in this manner accumulates, a cumulative science of behaviour change can develop.

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

    Science.gov (United States)

    Ilesanmi, Rose Ekama; Gillespie, Brigid M; Adejumo, Prisca Olabisi; Chaboyer, Wendy

    2015-07-28

    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. To present a protocol detailing the tailoring of international PUPCPG into a care bundle for the Nigerian context. 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. 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. 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.

  6. 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.

  7. An evaluation of two large scale demand side financing programs for maternal health in India: the MATIND study protocol

    Directory of Open Access Journals (Sweden)

    Sidney Kristi

    2012-08-01

    Full Text Available Abstract Background High maternal mortality in India is a serious public health challenge. Demand side financing interventions have emerged as a strategy to promote access to emergency obstetric care. Two such state run programs, Janani Suraksha Yojana (JSYand Chiranjeevi Yojana (CY, were designed and implemented to reduce financial access barriers that preclude women from obtaining emergency obstetric care. JSY, a conditional cash transfer, awards money directly to a woman who delivers in a public health facility. This will be studied in Madhya Pradesh province. CY, a voucher based program, empanels private obstetricians in Gujarat province, who are reimbursed by the government to perform deliveries of socioeconomically disadvantaged women. The programs have been in operation for the last seven years. Methods/designs The study outlined in this protocol will assess and compare the influence of the two programs on various aspects of maternal health care including trends in program uptake, institutional delivery rates, maternal and neonatal outcomes, quality of care, experiences of service providers and users, and cost effectiveness. The study will collect primary data using a combination of qualitative and quantitative methods, including facility level questionnaires, observations, a population based survey, in-depth interviews, and focus group discussions. Primary data will be collected in three districts of each province. The research will take place at three levels: the state health departments, obstetric facilities in the districts and among recently delivered mothers in the community. Discussion The protocol is a comprehensive assessment of the performance and impact of the programs and an economic analysis. It will fill existing evidence gaps in the scientific literature including access and quality to services, utilization, coverage and impact. The implementation of the protocol will also generate evidence to facilitate decision making

  8. An evaluation of two large scale demand side financing programs for maternal health in India: the MATIND study protocol.

    Science.gov (United States)

    Sidney, Kristi; de Costa, Ayesha; Diwan, Vishal; Mavalankar, Dileep V; Smith, Helen

    2012-08-27

    High maternal mortality in India is a serious public health challenge. Demand side financing interventions have emerged as a strategy to promote access to emergency obstetric care. Two such state run programs, Janani Suraksha Yojana (JSY)and Chiranjeevi Yojana (CY), were designed and implemented to reduce financial access barriers that preclude women from obtaining emergency obstetric care. JSY, a conditional cash transfer, awards money directly to a woman who delivers in a public health facility. This will be studied in Madhya Pradesh province. CY, a voucher based program, empanels private obstetricians in Gujarat province, who are reimbursed by the government to perform deliveries of socioeconomically disadvantaged women. The programs have been in operation for the last seven years. The study outlined in this protocol will assess and compare the influence of the two programs on various aspects of maternal health care including trends in program uptake, institutional delivery rates, maternal and neonatal outcomes, quality of care, experiences of service providers and users, and cost effectiveness. The study will collect primary data using a combination of qualitative and quantitative methods, including facility level questionnaires, observations, a population based survey, in-depth interviews, and focus group discussions. Primary data will be collected in three districts of each province. The research will take place at three levels: the state health departments, obstetric facilities in the districts and among recently delivered mothers in the community. The protocol is a comprehensive assessment of the performance and impact of the programs and an economic analysis. It will fill existing evidence gaps in the scientific literature including access and quality to services, utilization, coverage and impact. The implementation of the protocol will also generate evidence to facilitate decision making among policy makers and program managers who currently work with or

  9. Inadequacies in the civil nuclear liability regime evident after the Chernobyl accident: the response in the joint protocol of 1988

    International Nuclear Information System (INIS)

    Pelzer, N.

    1993-01-01

    The Joint Protocol of 21 September 1988 Relating to the Application of the Vienna Convention and the Paris Convention, by bridging both Conventions and by broadening thus the area where internationally harmonized nuclear liability law is applicable to nuclear incidents, contributes to doing away with inadequacies in the system of compensation for nuclear damage. On the other hand the Protocol has negative repercussions on the existing liability Conventions. Due to the enlargement of the territorial scope of application the compensation amounts available will be exhausted earlier. In order to avoid an aggravation of the legal position of the victims in the territories of the original Contracting Parties to the Vienna and the Paris Conventions the joint Protocol has to be responded to by a considerable increase of the compensation amounts

  10. Cancer incidence in kidney transplant recipients: a study protocol

    OpenAIRE

    Pita-Fernandez, Salvador; Valdes-Ca?edo, Francisco; Pertega-Diaz, Sonia; Seoane-Pillado, Maria Teresa; Seijo-Bestilleiro, Rocio

    2009-01-01

    Abstract Background Different publications show an increased incidence of neoplasms in renal transplant patients. The objective of this study is to determine the incidence of cancer in the recipients of renal transplants performed in the A Coruña Hospital (Spain) during the period 1981–2007. Methods/Design During the study period 1967 kidney transplants were performed, corresponding to 1710 patients. Patients with neoplasms prior to the transplant will be excluded (n = 38). A follow-up study ...

  11. Pregnancy outcome of “delayed start” GnRH antagonist protocol versus GnRH antagonist protocol in poor responders: A clinical trial study

    Directory of Open Access Journals (Sweden)

    Abbas Aflatoonian

    2017-08-01

    Full Text Available Background: Management of poor-responding patients is still major challenge in assisted reproductive techniques (ART. Delayed-start GnRH antagonist protocol is recommended to these patients, but little is known in this regards. Objective: The goal of this study was assessment of delayed-start GnRH antagonist protocol in poor responders, and in vitro fertilization (IVF outcomes. Materials and Methods: This randomized clinical trial included sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF. In case group (n=30, delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin. Control group (n=30 treated with estrogen priming antagonist protocol. Finally, endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy were compared between two groups. Results: Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles were higher although was not statistically significant. Endometrial thickness was significantly higher in case group. There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups. Conclusion: There is no significant difference between delayed-start GnRH antagonist protocol versus GnRH antagonist protocol.

  12. Health effects of smoke from planned burns: a study protocol

    Directory of Open Access Journals (Sweden)

    David O’Keeffe

    2016-02-01

    Full Text Available Abstract Background Large populations are exposed to smoke from bushfires and planned burns. Studies investigating the association between bushfire smoke and health have typically used hospital or ambulance data and been done retrospectively on large populations. The present study is designed to prospectively assess the association between individual level health outcomes and exposure to smoke from planned burns. Methods/design A prospective cohort study will be conducted during a planned burn season in three locations in Victoria (Australia involving 50 adult participants who undergo three rounds of cardiorespiratory medical tests, including measurements for lung inflammation, endothelial function, heart rate variability and markers of inflammation. In addition daily symptoms and twice daily lung function are recorded. Outdoor particulate air pollution is continuously measured during the study period in these locations. The data will be analysed using mixed effect models adjusting for confounders. Discussion Planned burns depend on weather conditions and dryness of ‘fuels’ (i.e. forest. It is potentially possible that no favourable conditions occur during the study period. To reduce the risk of this occurring, three separate locations have been identified as having a high likelihood of planned burn smoke exposure during the study period, with the full study being rolled out in two of these three locations. A limitation of this study is exposure misclassification as outdoor measurements will be conducted as a measure for personal exposures. However this misclassification will be reduced as participants are only eligible if they live in close proximity to the monitors.

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

    Directory of Open Access Journals (Sweden)

    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.

  14. Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

    Science.gov (United States)

    Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Zhang-Jin; Chan, Wai-Chi; Zhang, Shi-Ping; Ng, Roger Man-Kin; Chan, Connie Lai-Wah; Ho, Lai-Ming; Yu, Yee-Man; Lao, Li-Xing

    2017-03-31

    Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. ClinicalTrials.gov NCT02475538 .

  15. Parameters for determining inoculated pack/challenge study protocols.

    Science.gov (United States)

    2010-01-01

    The National Advisory Committee on Microbiological Criteria for Foods developed guidelines for conducting challenge studies on pathogen inhibition and inactivation studies in a variety of foods. The document is intended for use by the food industry, including food processors, food service operators, and food retailers; federal, state, and local food safety regulators; public health officials; food testing laboratories; and process authorities. The document is focused on and limited to bacterial inactivation and growth inhibition and does not make specific recommendations with respect to public health. The Committee concluded that challenge studies should be designed considering the most current advances in methodologies, current thinking on pathogens of concern, and an understanding of the product preparation, variability, and storage conditions. Studies should be completed and evaluated under the guidance of an expert microbiologist in a qualified laboratory and should include appropriate statistical design and data analyses. This document provides guidelines for choice of microorganisms for studies, inoculum preparation, inoculum level, methods of inoculation, incubation temperatures and times, sampling considerations, and interpreting test results. Examples of appropriately designed growth inhibition and inactivation studies are provided.

  16. 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

  17. EVA Human Health and Performance Benchmarking Study Overview and Development of a Microgravity Protocol

    Science.gov (United States)

    Norcross, Jason; Jarvis, Sarah; Bekdash, Omar; Cupples, Scott; Abercromby, Andrew

    2017-01-01

    The primary objective of this study is to develop a protocol to reliably characterize human health and performance metrics for individuals working inside various EVA suits under realistic spaceflight conditions. Expected results and methodologies developed during this study will provide the baseline benchmarking data and protocols with which future EVA suits and suit configurations (e.g., varied pressure, mass, center of gravity [CG]) and different test subject populations (e.g., deconditioned crewmembers) may be reliably assessed and compared. Results may also be used, in conjunction with subsequent testing, to inform fitness-for-duty standards, as well as design requirements and operations concepts for future EVA suits and other exploration systems.

  18. Impact of age on the selection of nuclear cardiology stress protocols: The INCAPS (IAEA nuclear cardiology protocols) study.

    Science.gov (United States)

    Al-Mallah, Mouaz H; Pascual, Thomas N B; Mercuri, Mathew; Vitola, João V; Karthikeyan, Ganesan; Better, Nathan; Dondi, Maurizio; Paez, Diana; Einstein, Andrew J

    2018-05-15

    There is growing concern about radiation exposure from nuclear myocardial perfusion imaging (MPI), particularly among younger patients who are more prone to develop untoward effects of ionizing radiation, and hence US and European professional society guidelines recommend age as a consideration in weighing radiation risk from MPI. We aimed to determine how patient radiation doses from MPI vary across age groups in a large contemporary international cohort. Data were collected as part of a global cross-sectional study of centers performing MPI coordinated by the International Atomic Energy Agency (IAEA). Sites provided information on each MPI study completed during a single week in March-April 2013. We compared across age groups laboratory adherence to pre-specified radiation-related best practices, radiation effective dose (ED; a whole-body measure reflecting the amount of radiation to each organ and its relative sensitivity to radiation's deleterious effects), and the proportion of patients with ED ≤ 9 mSv, a target level specified in guidelines. Among 7911 patients undergoing MPI in 308 laboratories in 65 countries, mean ED was 10.0 ± 4.5 mSv with slightly higher exposure among younger age groups (trend p value < 0.001). There was no difference in the proportion of patients with ED ≤ 9 mSv across age groups, or in adherence to best practices based on the median age of patients in a laboratory. In contemporary nuclear cardiology practice, the age of the patient appears not to impact protocol selection and radiation dose, contrary to professional society guidelines. Copyright © 2018. Published by Elsevier B.V.

  19. The Siblings With Ischemic Stroke Study (SWISS Protocol

    Directory of Open Access Journals (Sweden)

    Hardy John

    2002-02-01

    Full Text Available Abstract Background Family history and twins studies suggest an inherited component to ischemic stroke risk. Candidate gene association studies have been performed but have limited capacity to identify novel risk factor genes. The Siblings With Ischemic Stroke Study (SWISS aims to conduct a genome-wide scan in sibling pairs concordant or discordant for ischemic stroke to identify novel genetic risk factors through linkage analysis. Methods Screening at multiple clinical centers identifies patients (probands with radiographically confirmed ischemic stroke and a family history of at least 1 living full sibling with stroke. After giving informed consent, without violating privacy among other family members, the proband invites siblings concordant and discordant for stroke to participate. Siblings then contact the study coordinating center. The diagnosis of ischemic stroke in potentially concordant siblings is confirmed by systematic centralized review of medical records. The stroke-free status of potentially discordant siblings is confirmed by validated structured telephone interview. Blood samples for DNA analysis are taken from concordant sibling pairs and, if applicable, from 1 discordant sibling. Epstein-Barr virus-transformed lymphoblastoid cell lines are created, and a scan of the human genome is planned. Discussion Conducting adequately powered genomics studies of stroke in humans is challenging because of the heterogeneity of the stroke phenotype and the difficulty of obtaining DNA samples from clinically well-characterized members of a cohort of stroke pedigrees. The multicentered design of this study is intended to efficiently assemble a cohort of ischemic stroke pedigrees without invoking community consent or using cold-calling of pedigree members.

  20. Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cabassa, Leopoldo J; Stefancic, Ana; O'Hara, Kathleen; El-Bassel, Nabila; Lewis-Fernández, Roberto; Luchsinger, José A; Gates, Lauren; Younge, Richard; Wall, Melanie; Weinstein, Lara; Palinkas, Lawrence A

    2015-09-02

    The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese. The Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial. This paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI. www

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

    Directory of Open Access Journals (Sweden)

    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.

  2. The Spectrum of Histopathological Changes in the Renal Allograft - a 12 Months Protocol Biopsy Study

    Directory of Open Access Journals (Sweden)

    Galina Severova-Andreevska

    2018-03-01

    CONCLUSION: Our 12-month protocol biopsy study revealed the presence of different forms of mixed subclinical rejection. Use of recent BANFF classification and scoring system enables more precise diagnosis and subsequently different approach to the further treatment of the KTR. More correlative long-term studies including Anti HLA antibodies and Endothelial Cell Activation- Associated Transcripts (ENDAT are needed.

  3. Michigan dioxin exposure study: planning phase and protocol development

    Energy Technology Data Exchange (ETDEWEB)

    Adriaens, P. [Univ. of Michigan, Coll. of Engineering, Ann Arbor (United States); Garabrant, D.; Franzblau, A. [Univ. of Michigan, School for Public Health, Ann Arbor (United States); Gillespie, B. [Univ. of Michigan, Center for Statistics, Ann Arbor (United States); Lepowski, J. [Univ. of Michigan, Inst. for Social Research, Ann Arbor (United States)

    2004-09-15

    The University of Michigan has been commissioned to conduct one of the largest environmental epidemiology studies (700 residents) of dioxin exposure among the population of Michigan to describe the pattern of serum dioxin levels among adults and to understand the factors that explain variation in serum dioxin levels. The study is being undertaken (2004-2006) in response to concerns among the population of Midland and Saginaw Counties that dioxins from the Dow Chemical Company facilities in Midland have resulted in contamination of areas of the City of Midland and have contaminated the sediments in the Tittabawassee River flood plain. There is concern that body burdens of dioxins are elevated because of environmental contamination. The appropriate way to respond to these concerns is to measure the serum dioxin levels in a probability sample of the population in the region and to estimate each individual's past exposure to various factors that are believed to contribute to the body burden of dioxins. By measuring factors that reflect potential exposure to dioxins through air, water, soil, food intake, occupations, and various recreational activities, we can identify the factors that correlate with (and explain variation in) serum dioxin levels. The central goal of the study is to determine which factors explain variation in serum dioxin levels, and to quantify how much variation each factor explains. This paper provides information on the planning phase, study scope and objectives.

  4. Cognitive and Neurophysiological Recovery Following Electroconvulsive Therapy: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Ben J. A. Palanca

    2018-05-01

    Full Text Available Electroconvulsive therapy (ECT employs the elective induction of generalizes seizures as a potent treatment for severe psychiatric illness. As such, ECT provides an opportunity to rigorously study the recovery of consciousness, reconstitution of cognition, and electroencephalographic (EEG activity following seizures. Fifteen patients with major depressive disorder refractory to pharmacologic therapy will be enrolled (Clinicaltrials.gov, NCT02761330. Adequate seizure duration will be confirmed following right unilateral ECT under etomidate anesthesia. Patients will then undergo randomization for the order in which they will receive three sequential treatments: etomidate + ECT, ketamine + ECT, and ketamine + sham ECT. Sessions will be repeated in the same sequence for a total of six treatments. Before each session, sensorimotor speed, working memory, and executive function will be assessed through a standardized cognitive test battery. After each treatment, the return of purposeful responsiveness to verbal command will be determined. At this point, serial cognitive assessments will begin using the same standardized test battery. The presence of delirium and changes in depression severity will also be ascertained. Sixty-four channel EEG will be acquired throughout baseline, ictal, and postictal epochs. Mixed-effects models will correlate the trajectories of cognitive recovery, clinical outcomes, and EEG metrics over time. This innovative research design will answer whether: (1 time to return of responsiveness will be prolonged with ketamine + ECT compared with ketamine + sham ECT; (2 time of restoration to baseline function in each cognitive domain will take longer after ketamine + ECT than after ketamine + sham ECT; (3 postictal delirium is associated with delayed restoration of baseline function in all cognitive domains; and (4 the sequence of reconstitution of cognitive domains following the three treatments in this study is similar to that

  5. The Comparative Study Some of Reactive and Proactive Routing Protocols in The Wireless Sensor Network

    Directory of Open Access Journals (Sweden)

    Anas Ali Hussien

    2018-02-01

    Full Text Available The wireless sensor network (WSN consists mostly of a large number of nodes in a large area where not all nodes are directly connected. The applications of comprise a wide variety of scenarios.The mobile nodes are free to move because this network has selfــstructured topology. Routing protocols are responsible for detecting and maintaining paths in the network, and it classified into reactive (OnـــDemand, proactive (Table driven, and hybrid. In this paper represents a performance study of some WSN routing protocols: the Dynamic Source Routing (DSR, Ad hoc On-Demand Distance Vector (AODV, and Destination-Sequenced Distance-Vector (DSDV. The comparison made according to important metrics like packet delivery ratio (PDR, total packets dropped, Average end-to-end delay (Avg EED, and normalized routing load under the Transmission Control Protocol (TCP and User Datagram Protocol (UDP traffic connection and with varying number of nodes, pause time; and  varying speed. In this work used (NSــ2.35 that installed on (Ubuntu 14.04 operating system to implementing the scenario. Conclude that the DSR has better performance in TCP connection; while the DSDV has better performance in UDP protocol.

  6. Shortened protocol in practical [11C]SA4503-PET studies for sigma1 receptor quantification

    International Nuclear Information System (INIS)

    Sakata, Muneyuki; Kimura, Yuichi; Ishikawa, Masatomo; Oda, Keiichi; Ishii, Kenji; Ishiwata, Kiichi; Naganawa, Mika; Hashimoto, Kenji; Chihara, Kunihiro

    2008-01-01

    In practical positron emission tomography (PET) diagnosis, a shortened protocol is preferred for patients with brain disorders. In this study, the applicability of a shortened protocol as an alternative to the 90-min PET scan with [ 11 C]SA4503 for quantitative sigma 1 receptor measurement was investigated. Tissue time-activity curves of 288 regions of interest in the brain from 32 [ 11 C]SA4503-PET scans of 16 healthy subjects prior to and following administration of a selective serotonin reuptake inhibitor (fluvoxamine or paroxetine) were applied to two algorithms of quantitative analysis; binding potential (BP) was derived from compartmental analysis based on nonlinear estimation, and total distribution volume (tDV) was derived from Logan plot analysis. As a result, although both BP and tDV tended to be underestimated by the shortened method, the estimates from the shortened protocol had good linear relationships with those of the full-length protocol. In conclusion, if approximately 10% differences in the estimated results are acceptable for a specific purpose, then a 60-min measurement protocol is capable of providing reliable results. (author)

  7. 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

  8. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study.

    Science.gov (United States)

    Quanbeck, Andrew R; Gustafson, David H; Marsch, Lisa A; McTavish, Fiona; Brown, Randall T; Mares, Marie-Louise; Johnson, Roberta; Glass, Joseph E; Atwood, Amy K; McDowell, Helene

    2014-05-29

    Healthcare reform in the United States is encouraging Federally Qualified Health Centers and other primary-care practices to integrate treatment for addiction and other behavioral health conditions into their practices. The potential of mobile health technologies to manage addiction and comorbidities such as HIV in these settings is substantial but largely untested. This paper describes a protocol to evaluate the implementation of an E-Health integrated communication technology delivered via mobile phones, called Seva, into primary-care settings. Seva is an evidence-based system of addiction treatment and recovery support for patients and real-time caseload monitoring for clinicians. Our implementation strategy uses three models of organizational change: the Program Planning Model to promote acceptance and sustainability, the NIATx quality improvement model to create a welcoming environment for change, and Rogers's diffusion of innovations research, which facilitates adaptations of innovations to maximize their adoption potential. We will implement Seva and conduct an intensive, mixed-methods assessment at three diverse Federally Qualified Healthcare Centers in the United States. Our non-concurrent multiple-baseline design includes three periods - pretest (ending in four months of implementation preparation), active Seva implementation, and maintenance - with implementation staggered at six-month intervals across sites. The first site will serve as a pilot clinic. We will track the timing of intervention elements and assess study outcomes within each dimension of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, including effects on clinicians, patients, and practices. Our mixed-methods approach will include quantitative (e.g., interrupted time-series analysis of treatment attendance, with clinics as the unit of analysis) and qualitative (e.g., staff interviews regarding adaptations to implementation protocol) methods, and assessment of

  9. Protocol Development and Preliminary Toxicity Study of CBRN Nanomaterials

    Science.gov (United States)

    2013-12-05

    FBS) were purchased from ATCC and used for growing cells. 5.2.3 Positive Control The positive control, sodium lauryl sulfate (SLS), (Cat. # 71736 for 10...Inc.; New Castle, DE). Toxicology Study No. 87-XE-0EJ5-11 (FY12 Continuation) 5 5.1.2 Positive Control Zinc sulfate is recommended as a standard or...Inc.(Austin, TX). • Nano Sodium Bicarbonate is a component in the formulation being investigated as a replacement fire extinguishing agent for the Halon

  10. Standardization of a Videofluoroscopic Swallow Study Protocol to Investigate Dysphagia in Dogs.

    Science.gov (United States)

    Harris, R A; Grobman, M E; Allen, M J; Schachtel, J; Rawson, N E; Bennett, B; Ledyayev, J; Hopewell, B; Coates, J R; Reinero, C R; Lever, T E

    2017-03-01

    Videofluoroscopic swallow study (VFSS) is the gold standard for diagnosis of dysphagia in veterinary medicine but lacks standardized protocols that emulate physiologic feeding practices. Age impacts swallow function in humans but has not been evaluated by VFSS in dogs. To develop a protocol with custom kennels designed to allow free-feeding of 3 optimized formulations of contrast media and diets that address limitations of current VFSS protocols. We hypothesized that dogs evaluated by a free-feeding VFSS protocol would show differences in objective swallow metrics based on age. Healthy juvenile, adult, and geriatric dogs (n = 24). Prospective, experimental study. Custom kennels were developed to maintain natural feeding behaviors during VFSS. Three food consistencies (thin liquid, pureed food, and dry kibble) were formulated with either iohexol or barium to maximize palatability and voluntary prehension. Dogs were evaluated by 16 swallow metrics and compared across age groups. Development of a standardized VFSS protocol resulted in successful collection of swallow data in healthy dogs. No significant differences in swallow metrics were observed among age groups. Substantial variability was observed in healthy dogs when evaluated under these physiologic conditions. Features typically attributed to pathologic states, such as gastric reflux, were seen in healthy dogs. Development of a VFSS protocol that reflects natural feeding practices may allow emulation of physiology resulting in clinical signs of dysphagia. Age did not result in significant changes in swallow metrics, but additional studies are needed, particularly in light of substantial normal variation. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  11. Regional South Australia Health (RESONATE) survey: study protocol

    Science.gov (United States)

    Jones, Martin; Gillam, Marianne; May, Esther

    2018-01-01

    Introduction Access to quality healthcare services is considered a moral right. However, for people living in regional locations, timely access to the services that they need may not always be possible because of structural and attitudinal barriers. This suggests that people living in regional areas may have unmet healthcare needs. The aim of this research will be to examine the healthcare needs, expectations and experiences of regional South Australians. Methods and analysis The Regional South Australia Health (RESONATE) survey is a cross-sectional study of adult health consumers living in any private or non-private dwelling, in any regional, rural, remote or very remote area of South Australia and with an understanding of written English. Data will be collected using a 45-item, multidimensional, self-administered instrument, designed to measure healthcare need, barriers to healthcare access and health service utilisation, attitudes, experiences and satisfaction. The instrument has demonstrated acceptable psychometric properties, including good content validity and internal reliability, good test–retest reliability and a high level of acceptability. The survey will be administered online and in hard-copy, with at least 1832 survey participants to be recruited over a 12-month period, using a comprehensive, multimodal recruitment campaign. Ethics and dissemination The study has been reviewed and approved by the Human Research Ethics Committee of the University of South Australia. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media, the internet and various community/stakeholder engagement activities. PMID:29654014

  12. Cancer incidence in kidney transplant recipients: a study protocol

    International Nuclear Information System (INIS)

    Pita-Fernandez, Salvador; Valdes-Cañedo, Francisco; Pertega-Diaz, Sonia; Seoane-Pillado, Maria Teresa; Seijo-Bestilleiro, Rocio

    2009-01-01

    Different publications show an increased incidence of neoplasms in renal transplant patients. The objective of this study is to determine the incidence of cancer in the recipients of renal transplants performed in the A Coruña Hospital (Spain) during the period 1981–2007. During the study period 1967 kidney transplants were performed, corresponding to 1710 patients. Patients with neoplasms prior to the transplant will be excluded (n = 38). A follow-up study was carried out in order to estimate cancer incidence after transplantation. For each patient, information included donor and recipient characteristics, patients and graft survival and cancer incidence after transplantation. Incident cancer is considered as new cases of cancer after the transplant with anatomopathological confirmation. Their location will be classified according to the ICD-9. The analysis will be calculated using the indirect standardisation method. Age-adjusted cancer incidence rates in the Spanish general population will be obtained from the Carlos III Health Institute, the National Epidemiology Centre of the Ministry of Science and Technology. Crude first, second and third-year post-transplantation cancer incidence rates will be calculated for male and female recipients. The number of cases of cancer at each site will be calculated from data in the clinical records. The expected number of cancers will be calculated from data supplied by the Carlos III Health Institute. For each tumour location we will estimate the standardized incidence ratios (SIRs), using sex-specific cancer incidence rates, by dividing the incidence rate for the transplant patients by the rate of the general population. The 95% confidence intervals of the SIRs and their associated p-values will be calculated by assuming that the observed cancers follow a Poisson distribution. Stratified analysis will be performed to examine the variation in the SIRs with sex and length of follow-up. Competing risk survival analysis

  13. Replication protocol analysis: a method for the study of real-world design thinking

    DEFF Research Database (Denmark)

    Galle, Per; Kovacs, L. B.

    1996-01-01

    Given the brief of an architectural competition on site planning, and the design awarded the first prize, the first author (trained as an architect but not a participant in the competition) produced a line of reasoning that might have led from brief to design. In the paper, such ‘design replication......’ is refined into a method called ‘replication protocol analysis’ (RPA), and discussed from a methodological perspective of design research. It is argued that for the study of real-world design thinking this method offers distinct advantages over traditional ‘design protocol analysis’, which seeks to capture...

  14. Study protocol for the Fukushima health management survey

    International Nuclear Information System (INIS)

    Yasumura, Seiji; Hosoya, Mitsuaki; Yamashita, Shunichi; Kamiya, Kenji; Abe, Masafumi; Akashi, Makoto; Kodama, Kazunori; Ozasa, Kotaro

    2012-01-01

    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

  15. Study protocol for a multicenter investigation of reablement in Norway.

    Science.gov (United States)

    Langeland, Eva; Langland, Eva; Tuntland, Hanne; Førland, Oddvar; Aas, Eline; Folkestad, Bjarte; Jacobsen, Frode F; Kjeken, Ingvild

    2015-09-15

    Reablement is a promising new rehabilitation model, which is being implemented in some Western countries to meet current and future needs for home-based services. There is a need for further investigation of the effects of reablement among community-dwelling adults in terms of clinical and economic outcomes. This study will investigate the effectiveness of reablement in home-dwelling adults compared with standard treatment in terms of daily activities, physical functioning, health-related quality of life, coping, mental health, use of health care services, and costs. The study is a multicenter controlled trial. In total, 44 Norwegian municipalities will participate, including eight municipalities as a control group. For three municipalities with two zones, one will be assigned to the control group and the other to the intervention group. The experimental group will be offered reablement and the control group standard treatment. The sample will comprise approximately 750 participants. People will be eligible if they are home-dwelling adults, understand Norwegian, and have functional decline. Participants will be assessed at baseline, and after 10 weeks, 6 months, and 12 months. The primary outcome will be activity and participation measured by the Canadian Occupational Performance Measure. Physical functioning will be measured by the Short Physical Performance Battery and health-related quality of life by the European Quality of Life Scale. Coping will be measured by the Sense of Coherence questionnaire and mental health by the Mental Health Continuum Short Form. Costs will be generated based on registered working hours in different professions. Data analyses will be performed according to intention to treat. Univariate analysis of covariance will be used to investigate differences between the groups at baseline and the end of intervention. The data will be organized into two levels using a multilevel structure, i.e., individuals and municipalities, which will be

  16. Clinician, patient and general public beliefs about diagnostic imaging for low back pain: protocol for a qualitative evidence synthesis.

    Science.gov (United States)

    Traeger, Adrian C; Reed, Benjamin J; O'Connor, Denise A; Hoffmann, Tammy C; Machado, Gustavo C; Bonner, Carissa; Maher, Chris G; Buchbinder, Rachelle

    2018-02-10

    Little is known about how to reduce unnecessary imaging for low back pain. Understanding clinician, patient and general public beliefs about imaging is critical to developing strategies to reduce overuse. To synthesise qualitative research that has explored clinician, patient or general public beliefs about diagnostic imaging for low back pain. We will perform a qualitative evidence synthesis of relevant qualitative research exploring clinician, patient and general public beliefs about diagnostic imaging for low back pain. Exclusions will be studies not using qualitative methods and studies not published in English. Studies will be identified using sensitive search strategies in MEDLINE, EMBASE, CINAHL, AMED and PsycINFO. Two reviewers will independently apply inclusion and exclusion criteria, extract data, and use the Critical Appraisal Skills Programme quality assessment tool to assess the quality of included studies. To synthesise the data we will use a narrative synthesis approach that involves developing a theoretical model, conducting a preliminary synthesis, exploring relations in the data, and providing a structured summary. We will code the data using NVivo. At least two reviewers will independently apply the thematic framework to extracted data. Confidence in synthesis findings will be evaluated using the GRADE Confidence in the Evidence from Reviews of Qualitative Research tool. Ethical approval is not required to conduct this review. We will publish the results in a peer-reviewed journal. CRD42017076047. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. Study protocol: can a school gardening intervention improve children's diets?

    Science.gov (United States)

    Christian, Meaghan S; El Evans, Charlotte; Conner, Mark; Ransley, Joan K; Cade, Janet E

    2012-04-26

    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. 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. 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. ISRCTN11396528.

  18. 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

  19. 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

  20. Journey to vaccination: a protocol for a multinational qualitative study.

    Science.gov (United States)

    Wheelock, Ana; Miraldo, Marisa; Parand, Anam; Vincent, Charles; Sevdalis, Nick

    2014-01-31

    In the past two decades, childhood vaccination coverage has increased dramatically, averting an estimated 2-3 million deaths per year. Adult vaccination coverage, however, remains inconsistently recorded and substandard. Although structural barriers are known to limit coverage, social and psychological factors can also affect vaccine uptake. Previous qualitative studies have explored beliefs, attitudes and preferences associated with seasonal influenza (flu) vaccination uptake, yet little research has investigated how participants' context and experiences influence their vaccination decision-making process over time. This paper aims to provide a detailed account of a mixed methods approach designed to understand the wider constellation of social and psychological factors likely to influence adult vaccination decisions, as well as the context in which these decisions take place, in the USA, the UK, France, India, China and Brazil. We employ a combination of qualitative interviewing approaches to reach a comprehensive understanding of the factors influencing vaccination decisions, specifically seasonal flu and tetanus. To elicit these factors, we developed the journey to vaccination, a new qualitative approach anchored on the heuristics and biases tradition and the customer journey mapping approach. A purposive sampling strategy is used to select participants who represent a range of key sociodemographic characteristics. Thematic analysis will be used to analyse the data. Typical journeys to vaccination will be proposed. Vaccination uptake is significantly influenced by social and psychological factors, some of which are under-reported and poorly understood. This research will provide a deeper understanding of the barriers and drivers to adult vaccination. Our findings will be published in relevant peer-reviewed journals and presented at academic conferences. They will also be presented as practical recommendations at policy and industry meetings and healthcare

  1. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  2. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

    Science.gov (United States)

    Lauzier, F; Adhikari, N K; Seely, A; Koo, K K Y; Belley-Côté, E P; Burns, K E A; Cook, D J; D'Aragon, F; Rochwerg, B; Kho, M E; Oczkowksi, S J W; Duan, E H; Meade, M O; Day, A G; Lamontagne, F

    2017-07-17

    The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

  3. Evidence Study Guide. Revision (Naval Justice School)

    Science.gov (United States)

    1992-07-01

    404(b). See United States v. Thomas, 11 M.J. 388 (C.M.A. 1981) and United States v. Dawkins 2 M.J. 898 (A.C.M.R. 1976) (pre-Mil.R.Evid. cases applying...criminal activity). 1313 BODY INTRUSiONS (Key N-;i-,crs 1049 et seq) A. Genes - 1. Mil.R.Evid. 312. Certain searches, such as searches of body cavities...inflammatory. For example, the trial counsel may not assert that the members are " selfish , self-centered and are not fulfilling [their] responsibility to

  4. Economic evaluation of manual therapy for musculoskeletal diseases: a protocol for a systematic review and narrative synthesis of evidence.

    Science.gov (United States)

    Kim, Chang-Gon; Mun, Su-Jeong; Kim, Ka-Na; Shin, Byung-Cheul; Kim, Nam-Kwen; Lee, Dong-Hyo; Lee, Jung-Han

    2016-05-13

    Manual therapy is the non-surgical conservative management of musculoskeletal disorders using the practitioner's hands on the patient's body for diagnosing and treating disease. The aim of this study is to systematically review trial-based economic evaluations of manual therapy relative to other interventions used for the management of musculoskeletal diseases. Randomised clinical trials (RCTs) on the economic evaluation of manual therapy for musculoskeletal diseases will be included in the review. The following databases will be searched from their inception: Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Econlit, Mantis, Index to Chiropractic Literature, Science Citation Index, Social Science Citation Index, Allied and Complementary Medicine Database (AMED), Cochrane Database of Systematic Reviews (CDSR), National Health Service Database of Abstracts of Reviews of Effects (NHS DARE), National Health Service Health Technology Assessment Database (NHS HTA), National Health Service Economic Evaluation Database (NHS EED), CENTRAL, five Korean medical databases (Oriental Medicine Advanced Searching Integrated System (OASIS), Research Information Service System (RISS), DBPIA, Korean Traditional Knowledge Portal (KTKP) and KoreaMed) and three Chinese databases (China National Knowledge Infrastructure (CNKI), VIP and Wanfang). The evidence for the cost-effectiveness, cost-utility and cost-benefit of manual therapy for musculoskeletal diseases will be assessed as the primary outcome. Health-related quality of life and adverse effects will be assessed as secondary outcomes. We will critically appraise the included studies using the Cochrane risk of bias tool and the Drummond checklist. Results will be summarised using Slavin's qualitative best-evidence synthesis approach. The results of the study will be disseminated via a peer-reviewed journal and/or conference presentations

  5. Metacognitive Protocols: A Qualitative Study of Perceptions of "Smartness" of Adults and Children.

    Science.gov (United States)

    Morse, Linda W.; Smith-Mallette, Geraldine; Talento-Miller, Eileen

    Metacognition is a theoretical construct used to describe individuals' perceptions of their thinking processes and their own control over their thinking processes. This study examined the protocols of 78 undergraduates who responded to 3 questions from the Swanson Metacognitive Questionnaire: (1) What makes someone really smart? (2) How do…

  6. Study protocol: A Montessori approach to dementia-related, non-residential respite services in Australia.

    Science.gov (United States)

    Hanna, Andrew; Donnelly, James; Aggar, Christina

    2018-03-27

    Given the social burden and significant cost of dementia care in Australia, finding evidence-based approaches that improve outcomes, maintain independence, and reduce the impact on patients and families is essential. Finding effective ways to train and assist the healthcare staff who support these individuals is also critical, as they are considered to be at risk of workplace stress, burnout, and other psychological disturbances which negatively affects standards of care. The current paper describes a protocol for evaluating the effects of a Montessori-based approach to dementia care, in non-residential respite centres. An 18 month prospective observational, cohort controlled design is suggested that will compare participants from a community respite service that has undergone a Montessori-based workplace culture change and those from a service that provides a person-centred 'care as usual' approach. To achieve this, the protocol includes the assessment of participants across multiple variables on a monthly basis including the cognitive, behavioural, and emotional functioning of clients with dementia, levels of caregiver burden experienced by informal carers, and burnout, compassion satisfaction and workplace engagement among respite staff. The protocol also employs a qualitative evaluation of program fidelity. This approach will provide further insight into the potential benefits of early intervention with Montessori approaches for persons living with dementia in the community, their caregivers, and the staff and volunteers who assist them. Copyright © 2018 Elsevier B.V. All rights reserved.

  7. Study protocol

    DEFF Research Database (Denmark)

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

    2012-01-01

    ranging from total blindness to Snellen visual acuity 6/60 receive information letter and questionnaire by post. Completed questionnaires can be returned by post, email or telephone. For each respondent, all eye-related diagnoses will be obtained from national registries. Normally sighted...... and demographically matched control respondents will be contacted in a similar manner the subsequent winter season. The Seasonal Pattern Assessment Questionnaire rates seasonal variation within the six items: sleep, appetite, social activity, mood, energy and body weight. The Seasonal Pattern Assessment Questionnaire...

  8. Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

    Science.gov (United States)

    Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

    2014-12-01

    Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

  9. Mapping evidence on the distribution of human papillomavirus-related cancers in sub-Saharan Africa: scoping review protocol.

    Science.gov (United States)

    Lekoane, Bridget K M; Mashamba-Thompson, Tivani P; Ginindza, Themba G

    2017-11-17

    Despite the introduction of HPV vaccines, the incidence of HPV-related cancers (cervical, penile, anal, vulvar, vagina, head, and neck) in sub-Saharan Africa has been rising. The increasing incidence of these HPV-related cancers has been attributed to changes in lifestyle-related risk factors, most notably sexual behavior. The main objective of this study is to map evidence on the distribution of HIV-related cancers in sub-Saharan Africa (SSA). We will conduct a scoping review to explore, describe, and map literature on the distribution of HPV-related cancers in sub-Saharan Africa. The primary search will include peer-reviewed and review articles. The list of references from included studies will also be searched. The search will be performed using EBSCOhost platform by searching the following databases within the platform: Academic search complete, health source: nursing/academic edition, CINAHL with full text, PubMed, Science Direct, Google scholar and World Health Organization (WHO) library databases, and gray literature. The researcher will search the articles using keywords, from the included studies; abstract and full articles will be screened by two independent reviewers. The screening will be guided by the inclusion and exclusion criteria. A thematic content analysis will be used to present the narrative account of the reviews, using NVivo version 10. We anticipate finding relevant literature on the distribution of HPV-related cancers in sub-Saharan Africa. The study findings will help reveal research gaps to guide future research. PROSPERO CRD42017062403.

  10. Dosimetry study on the conventional and three dimensional conformal radiation treatment planning protocols for rectal cancer

    International Nuclear Information System (INIS)

    Cai Yong; He Yuxiang; Han Shukui; Wu Hao; Gong Jian; Xu Bo

    2007-01-01

    Objective: To compare the dose distribution of clinical target volume (CTV), in normal tissues and organs for patients with rectal cancer on the conventional radiotherapy (2D) and three dimension- al conformal radiation treatment (3DCRT). Methods: The CT image data of 36 rectal cancer patients treated with 3DCRT were studied. The CTV, small bowel, colon, bladder, pelvic bone marrow, and femoral head and neck were contoured on consecutive axial slices of CT images. Two 3DCRT and three conventional treatment planning protocols were simulated using three dimensional treatment planning system (CMS Focus 2.31), were defined as 3D-3, 3D-4, 2D-2, 2D-3, 2D-4. The difference of five treatment planning protocols on the CTV and normal structure by analysis of dose-volume histograms (DVHs) were compared. Results: The D 95 and V 95 of these five protocols all exceeded 97%. The conformity index(CI) of 3D was obviously larger than that of 2D protocol. The dose inhomogeneity(DI) in 4 DCRT was less than that of 3 DCRT. The 3D as compared with the 2D, significantly reduced the mean dose of 45 Gy to the small bowel and colon. The 3D-3 as compared with the 2D-3, the 3D-4 as compared with the 2D-4, the mean dose of small bowel and colon was reduced by 28.5% and 25.7%, respectively. The 3D-3 as compared with the 2D-2, the 3D-3 as compared with the 2D-3 and the 3D4 as compared with the 2D-4, the percentage volume of small bowel and colon which received 45 Gy was reduced by 80.8% , 51.1% and 54.7% , respectively. Either the mean dose, or the percentage volume receiving 35 Gy and 45 Gy to the pelvic bone and bladder, the 3D planning protocols had advanage over the 2D planning protocols. The V 45 of bladder in 2D-2 planning proto- col was the highest in all planning protocols, exceeding 98%, but the highest V 45 of bladder was only 50% in the other planning protocols. Conclusions: Even though the difference in pelvic CTV of rectal cancer patients between the conventional radiotherapy and 3

  11. Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. Methods/design This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). Discussion This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. Trial registration The trial

  12. Use of an evidence-based protocol to screen for sleep-disordered breathing in a heart failure disease management clinic.

    Science.gov (United States)

    Garner, Shelby L; Traverse, Ramona D

    2014-01-01

    Undiagnosed and untreated sleep-disordered breathing can lead to negative health outcomes and increased utilization of health resources among patients with heart failure. The purpose of this evidence-based practice project was to implement and evaluate a new multifaceted sleep-disordered breathing screening protocol in a heart failure disease management clinic. The combined use of a symptoms questionnaire, the Epworth sleepiness scale, and overnight pulse oximetry was significantly more effective in identifying patients with a positive diagnosis of sleep-disordered breathing than using the Epworth sleepiness scale alone (P < .05).

  13. 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...

  14. A systematic review of protocol studies on conceptual design cognition: design as search and exploration

    OpenAIRE

    Hay, Laura; Duffy, Alex H.B.; McTeague, Chris; Pidgeon, Laura M.; Vuletic, Tijana; Grealy, Madeleine

    2017-01-01

    This paper reports findings from the first systematic review of protocol studies focusing specifically on conceptual design cognition, aiming to answer the following research question: What is our current understanding of the cognitive processes involved in conceptual design tasks carried out by individual designers? We reviewed 47 studies on architectural design, engineering design and product design engineering. This paper reports 24 cognitive processes investigated in a subset of 33 studie...

  15. A novel protocol for dispatcher assisted CPR improves CPR quality and motivation among rescuers-A randomized controlled simulation study.

    Science.gov (United States)

    Rasmussen, Stinne Eika; Nebsbjerg, Mette Amalie; Krogh, Lise Qvirin; Bjørnshave, Katrine; Krogh, Kristian; Povlsen, Jonas Agerlund; Riddervold, Ingunn Skogstad; Grøfte, Thorbjørn; Kirkegaard, Hans; Løfgren, Bo

    2017-01-01

    Emergency dispatchers use protocols to instruct bystanders in cardiopulmonary resuscitation (CPR). Studies changing one element in the dispatcher's protocol report improved CPR quality. Whether several changes interact is unknown and the effect of combining multiple changes previously reported to improve CPR quality into one protocol remains to be investigated. We hypothesize that a novel dispatch protocol, combining multiple beneficial elements improves CPR quality compared with a standard protocol. A novel dispatch protocol was designed including wording on chest compressions, using a metronome, regular encouragements and a 10-s rest each minute. In a simulated cardiac arrest scenario, laypersons were randomized to perform single-rescuer CPR guided with the novel or the standard protocol. a composite endpoint of time to first compression, hand position, compression depth and rate and hands-off time (maximum score: 22 points). Afterwards participants answered a questionnaire evaluating the dispatcher assistance. The novel protocol (n=61) improved CPR quality score compared with the standard protocol (n=64) (mean (SD): 18.6 (1.4)) points vs. 17.5 (1.7) points, pCPR. A novel bundle of care protocol improved CPR quality score and motivation among rescuers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence (DECIDE): protocol and preliminary results

    NARCIS (Netherlands)

    Treweek, Shaun; Oxman, Andrew D.; Alderson, Philip; Bossuyt, Patrick M.; Brandt, Linn; Brożek, Jan; Davoli, Marina; Flottorp, Signe; Harbour, Robin; Hill, Suzanne; Liberati, Alessandro; Liira, Helena; Schünemann, Holger J.; Rosenbaum, Sarah; Thornton, Judith; Vandvik, Per Olav; Alonso-Coello, Pablo; Hartley, Claire; Loudon, Kirsty; Slater, William; Stewart, Neil; Glenton, Claire; Kristiansen, Annette; Lewin, Simon; Moberg, Jenny; Morelli, Angela; Oxman, Andy; Ødgaard-Jensen, Jan; Martinez-García, Laura; Rigau, David; Solà, Ivan; Sanabria, Andrea Juliana; Amato, Laura; Brunetti, Massimo; Magrini, Nicola; Parmelli, Elena; Nonino, Francesco; de Palma, Rossana; Papini, Donato; Pregno, Silvia; Saitto, Carlo; Gopalakrishna, Gowri; Langendam, Miranda; Leeflang, Mariska; Scholten, Rob; Gülmezoglu, Metin; Permanand, Govin; Weerasuriyak, Krisantha; Antes, Gerd; Meerpohl, Jörg

    2013-01-01

    Healthcare decision makers face challenges when using guidelines, including understanding the quality of the evidence or the values and preferences upon which recommendations are made, which are often not clear. GRADE is a systematic approach towards assessing the quality of evidence and the

  17. A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

    Science.gov (United States)

    Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

    2018-05-15

    To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

  18. Efficacy of Evidence Based Care on Care Quality of Mother and Infant in 3 Teaching Hospitals: A Protocol

    Directory of Open Access Journals (Sweden)

    Davoodi R

    2014-04-01

    Full Text Available Introduction: Reducing infant mortality rate during delivery is a priority in the world. Even with the existing activities that take place in hospitals, due to a lack of simple and effective methods, this mortality reduction trend is slow. The objects of this study were to apply and investigate the effects of WHO evidence-based guidelines for safe delivery on the quality of maternal and neonatal support. Materials and Methods: This is a semi-experimental study with external control. After forward and backward translation of WHO safe childbirth checklist, in an expert meeting irrelevant/infeasible items in the checklist were omitted or modified. Personnel performance on checklist items was evaluated by researchers who were present in the whole period of mother and neonate hospitalization in two phases. Intervention was done in two hospitals and one hospital was considered as control. At first, the instructions were provided for all the collaborating personnel in forms of pamphlets, posters and booklets and after two weeks second phase began by arranging an educational session for personnel. The data of these two phases is being compared. Discussion: If our prior assumption be proved, we anticipate improvements in some items of checklist .Some of these items are skin contact, breast feeding rate in first hour postpartum, hand hygiene, and mother's knowledge regarding the parturition during the time in which they are hospitalized together with a decrease in episiotomy infection/dehiscence prevalence. These changes can be regarded as an overall promotion in maternal/neonatal support.

  19. 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.

  20. Naval Justice School Evidence Study Guide. Revision

    Science.gov (United States)

    1989-01-01

    it may even be necessary for the military judge to breach a privilege in order to see if that privilege exists. See, eq., Lutwak v. United States, 344...other. Mil.R.Evid. 504(c)(2)(B). See also Lutwak v. United States, 344 U.S. 604 (1953) (describes factual situation which depicts a marital sham). 6...only against the actor or declarant. See, eg., Lutwak v. United States, 344 U.S. 604 (1953); United States v. Beverly, 14 C.M.A. 468, 34 C.M.R. 248

  1. Input of Psychosocial Information During Multidisciplinary Team Meetings at Medical Oncology Departments: Protocol for an Observational Study.

    Science.gov (United States)

    Horlait, Melissa; Van Belle, Simon; Leys, Mark

    2018-02-26

    Multidisciplinary team meetings (MDTMs) have become standard practice in oncology and gained the status of the key decision-making forum for cancer patient management. The current literature provides evidence that MDTMs are achieving their intended objectives but there are also indications to question the positive impact of MDTMs in oncology settings. For cancer management to be patient-centered, it is crucial that medical information as well as psychosocial aspects-such as the patients' living situation, possible family problems, patients' mental state, and patients' perceptions and values or preferences towards treatment or care-are considered and discussed during MDTMs. Previous studies demonstrate that failure to account for patients' psychosocial information has a negative impact on the implementation of the treatment recommendations formulated during MDTMs. Few empirical studies have demonstrated the predominant role of physicians during MDTMs, leading to the phenomenon that medical information is shared almost exclusively at the expense of psychosocial information. However, more in-depth insight on the underlying reasons why MDTMs fail to take into account psychosocial information of cancer patients is needed. This paper presents a research protocol for a cross-sectional observational study that will focus on exploring the barriers to considering psychosocial information during MDTMs at medical oncology departments. This protocol encompasses a cross-sectional comparative case study of MDTMs at medical oncology departments in Flanders, Belgium. MDTMs from various oncology subspecialties at inpatient medical oncology departments in multiple hospitals (academic as well as general hospitals) are compared. The observations focus on the "multidisciplinary oncology consultation" (MOC), a formally regulated and financed type of MDTM in Belgian oncology since 2003. Data are collected through nonparticipant observations of MOC-meetings. Observational data are

  2. Improving implementation of evidence-based practice in mental health service delivery: protocol for a cluster randomised quasi-experimental investigation of staff-focused values interventions.

    Science.gov (United States)

    Williams, Virginia; Oades, Lindsay G; Deane, Frank P; Crowe, Trevor P; Ciarrochi, Joseph; Andresen, Retta

    2013-07-02

    There is growing acceptance that optimal service provision for individuals with severe and recurrent mental illness requires a complementary focus on medical recovery (i.e., symptom management and general functioning) and personal recovery (i.e., having a 'life worth living'). Despite significant research attention and policy-level support, the translation of this vision of healthcare into changed workplace practice continues to elude. Over the past decade, evidence-based training interventions that seek to enhance the knowledge, attitudes, and skills of staff working in the mental health field have been implemented as a primary redress strategy. However, a large body of multi-disciplinary research indicates disappointing rates of training transfer. There is an absence of empirical research that investigates the importance of worker-motivation in the uptake of desired workplace change initiatives. 'Autonomy' is acknowledged as important to human effectiveness and as a correlate of workplace variables like productivity, and wellbeing. To our knowledge, there have been no studies that investigate purposeful and structured use of values-based interventions to facilitate increased autonomy as a means of promoting enhanced implementation of workplace change. This study involves 200 mental health workers across 22 worksites within five community-managed organisations in three Australian states. It involves cluster-randomisation of participants within organisation, by work site, to the experimental (values) condition, or the control (implementation). Both conditions receive two days of training focusing on an evidence-based framework of mental health service delivery. The experimental group receives a third day of values-focused intervention and 12 months of values-focused coaching. Well-validated self-report measures are used to explore variables related to values concordance, autonomy, and self-reported implementation success. Audits of work files and staff work samples

  3. Mapping evidence on the distribution of human papillomavirus-related cancers in sub-Saharan Africa: scoping review protocol

    Directory of Open Access Journals (Sweden)

    Bridget K. M. Lekoane

    2017-11-01

    Full Text Available Abstract Background Despite the introduction of HPV vaccines, the incidence of HPV-related cancers (cervical, penile, anal, vulvar, vagina, head, and neck in sub-Saharan Africa has been rising. The increasing incidence of these HPV-related cancers has been attributed to changes in lifestyle-related risk factors, most notably sexual behavior. The main objective of this study is to map evidence on the distribution of HIV-related cancers in sub-Saharan Africa (SSA. Methods and analysis We will conduct a scoping review to explore, describe, and map literature on the distribution of HPV-related cancers in sub-Saharan Africa. The primary search will include peer-reviewed and review articles. The list of references from included studies will also be searched. The search will be performed using EBSCOhost platform by searching the following databases within the platform: Academic search complete, health source: nursing/academic edition, CINAHL with full text, PubMed, Science Direct, Google scholar and World Health Organization (WHO library databases, and gray literature. The researcher will search the articles using keywords, from the included studies; abstract and full articles will be screened by two independent reviewers. The screening will be guided by the inclusion and exclusion criteria. A thematic content analysis will be used to present the narrative account of the reviews, using NVivo version 10. Discussion We anticipate finding relevant literature on the distribution of HPV-related cancers in sub-Saharan Africa. The study findings will help reveal research gaps to guide future research. Systematic review registration PROSPERO CRD42017062403.

  4. 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

    , and pharmacological treatment of the psychiatric symptoms is difficult, requiring specialist proficiency in the field. Pilot study: As there is not yet sufficient research that examines the effects of non-pharmacologic treatment with this group there is a need to develop valid and reliable research protocols....... 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...... changes in intersubjectivity. In this pilot testing there was a specific interest in selecting a relevant and manageable dementia specific instrument for measuring quality of life and relating it with other instruments. Following three instruments were tested: the Altzheimers Disease-Related Quality...

  5. Evident?

    DEFF Research Database (Denmark)

    Plant, Peter

    2012-01-01

    Quality assurance and evidence in career guidance in Europe are often seen as self-evident approaches, but particular interests lie behind......Quality assurance and evidence in career guidance in Europe are often seen as self-evident approaches, but particular interests lie behind...

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

    International Nuclear Information System (INIS)

    Kretzschmar, S.P.; Bedi, G.S.; Martinez, P.; Ervin, K.

    1996-07-01

    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

  7. Thromboelastometry versus standard coagulation tests versus restrictive protocol to guide blood transfusion prior to central venous catheterization in cirrhosis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rocha, Leonardo Lima; Pessoa, Camila Menezes Souza; Neto, Ary Serpa; do Prado, Rogerio Ruscitto; Silva, Eliezer; de Almeida, Marcio Dias; Correa, Thiago Domingos

    2017-02-27

    Liver failure patients have traditionally been empirically transfused prior to invasive procedures. Blood transfusion is associated with immunologic and nonimmunologic reactions, increased risk of adverse outcomes and high costs. Scientific evidence supporting empirical transfusion is lacking, and the best approach for blood transfusion prior to invasive procedures in cirrhotic patients has not been established so far. The aim of this study is to compare three transfusion strategies (routine coagulation test-guided - ordinary or restrictive, or thromboelastometry-guided) prior to central venous catheterization in critically ill patients with cirrhosis. Design and setting: a double-blinded, parallel-group, single-center, randomized controlled clinical trial in a tertiary private hospital in São Paulo, Brazil. adults (aged 18 years or older) admitted to the intensive care unit with cirrhosis and an indication for central venous line insertion. Patients will be randomly assigned to three groups for blood transfusion strategy prior to central venous catheterization: standard coagulation tests-based, thromboelastometry-based, or restrictive. The primary efficacy endpoint will be the proportion of patients transfused with any blood product prior to central venous catheterization. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of transfusion of fresh frozen plasma, platelets and cryoprecipitate; infused volume of blood products; hemoglobin and hematocrit before and after the procedure; intensive care unit and hospital length of stay; 28-day and hospital mortality; incidence of minor bleeding; transfusion-related adverse reactions; and cost analysis. This study will evaluate three strategies to guide blood transfusion prior to central venous line placement in severely ill patients with cirrhosis. We hypothesized that thromboelastometry-based and/or restrictive protocols are safe and would significantly

  8. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial.

    Science.gov (United States)

    Middleton, Sandy; McElduff, Patrick; Ward, Jeanette; Grimshaw, Jeremy M; Dale, Simeon; D'Este, Catherine; Drury, Peta; Griffiths, Rhonda; Cheung, N Wah; Quinn, Clare; Evans, Malcolm; Cadilhac, Dominique; Levi, Christopher

    2011-11-12

    We assessed patient outcomes 90 days after hospital admission for stroke following a multidisciplinary intervention targeting evidence-based management of fever, hyperglycaemia, and swallowing dysfunction in acute stroke units (ASUs). In the Quality in Acute Stroke Care (QASC) study, a single-blind cluster randomised controlled trial, we randomised ASUs (clusters) in New South Wales, Australia, with immediate access to CT and on-site high dependency units, to intervention or control group. Patients were eligible if they spoke English, were aged 18 years or older, had had an ischaemic stroke or intracerebral haemorrhage, and presented within 48 h of onset of symptoms. Intervention ASUs received treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction with multidisciplinary team building workshops to address implementation barriers. Control ASUs received only an abridged version of existing guidelines. We recruited pre-intervention and post-intervention patient cohorts to compare 90-day death or dependency (modified Rankin scale [mRS] ≥2), functional dependency (Barthel index), and SF-36 physical and mental component summary scores. Research assistants, the statistician, and patients were masked to trial groups. All analyses were done by intention to treat. This trial is registered at the Australia New Zealand Clinical Trial Registry (ANZCTR), number ACTRN12608000563369. 19 ASUs were randomly assigned to intervention (n=10) or control (n=9). Of 6564 assessed for eligibility, 1696 patients' data were obtained (687 pre-intervention; 1009 post-intervention). Results showed that, irrespective of stroke severity, intervention ASU patients were significantly less likely to be dead or dependent (mRS ≥2) at 90 days than control ASU patients (236 [42%] of 558 patients in the intervention group vs 259 [58%] of 449 in the control group, p=0·002; number needed to treat 6·4; adjusted absolute difference 15·7% [95% CI 5·8-25·4]). They also had a

  9. Presenting evidence-based health information for people with multiple sclerosis: the IN-DEEP project protocol.

    Science.gov (United States)

    Hill, Sophie; Filippini, Graziella; Synnot, Anneliese; Summers, Michael; Beecher, Deirdre; Colombo, Cinzia; Mosconi, Paola; Battaglia, Mario A; Shapland, Sue; Osborne, Richard H; Hawkins, Melanie

    2012-03-16

    Increasingly, evidence-based health information, in particular evidence from systematic reviews, is being made available to lay audiences, in addition to health professionals. Research efforts have focused on different formats for the lay presentation of health information. However, there is a paucity of data on how patients integrate evidence-based health information with other factors such as their preferences for information and experiences with information-seeking. The aim of this project is to explore how people with multiple sclerosis (MS) integrate health information with their needs, experiences, preferences and values and how these factors can be incorporated into an online resource of evidence-based health information provision for people with MS and their families. This project is an Australian-Italian collaboration between researchers, MS societies and people with MS. Using a four-stage mixed methods design, a model will be developed for presenting evidence-based health information on the Internet for people with MS and their families. This evidence-based health information will draw upon systematic reviews of MS interventions from The Cochrane Library. Each stage of the project will build on the last. After conducting focus groups with people with MS and their family members (Stage 1), we will develop a model for summarising and presenting Cochrane MS reviews that is integrated with supporting information to aid understanding and decision making. This will be reviewed and finalised with people with MS, family members, health professionals and MS Society staff (Stage 2), before being uploaded to the Internet and evaluated (Stages 3 and 4). This project aims to produce accessible and meaningful evidence-based health information about MS for use in the varied decision making and management situations people encounter in everyday life. It is expected that the findings will be relevant to broader efforts to provide evidence-based health information for

  10. Systems consultation: protocol for a novel implementation strategy designed to promote evidence-based practice in primary care

    OpenAIRE

    Quanbeck, Andrew; Brown, Randall T; E Zgierska, Aleksandra; A Johnson, Roberta; Robinson, James M; Jacobson, Nora

    2016-01-01

    Background Adoption of evidence-based practices takes place at a glacial place in healthcare. This research will pilot test an innovative implementation strategy ? systems consultation ?intended to speed the adoption of evidence-based practice in primary care. The strategy is based on tenets of systems engineering and has been extensively tested in addiction treatment. Three innovations have been included in the strategy ? translation of a clinical practice guideline into a checklist-based im...

  11. The FLASSH study: protocol for a randomised controlled trial evaluating falls prevention after stroke and two sub-studies

    Directory of Open Access Journals (Sweden)

    Mackintosh Shylie F

    2009-03-01

    Full Text Available Abstract Background Falls are common in stroke survivors returning home after rehabilitation, however there is currently a lack of evidence about preventing falls in this population. This paper describes the study protocol for the FLASSH (FaLls prevention After Stroke Survivors return Home project. Methods and design This randomised controlled trial aims to evaluate the effectiveness of a multi-factorial falls prevention program for stroke survivors who are at high risk of falling when they return home after rehabilitation. Intervention will consist of a home exercise program as well as individualised falls prevention and injury minimisation strategies based on identified risk factors for falls. Additionally, two sub-studies will be implemented in order to explore other key areas related to falls in this population. The first of these is a longitudinal study evaluating the relationship between fear of falling, falls and function over twelve months, and the second evaluates residual impairment in gait stability and obstacle crossing twelve months after discharge from rehabilitation. Discussion The results of the FLASSH project will inform falls prevention practice for stroke survivors. If the falls prevention program is shown to be effective, low cost strategies to prevent falls can be implemented for those at risk around the time of discharge from rehabilitation, thus improving safety and quality of life for stroke survivors. The two sub-studies will contribute to the overall understanding and management of falls risk in stroke survivors. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN012607000398404.

  12. The precautionary principle as a provisional instrument in environmental policy: The Montreal Protocol case study

    International Nuclear Information System (INIS)

    Jacobs, J. Roger

    2014-01-01

    Highlights: • I examine whether a policy invoked under the Precautionary Principle can move beyond provisional status. • I review the certainty of conclusions based upon the Global Ozone Research and Monitoring Project. • There is high certainty that anthropogenic ozone depletion has health consequences in polar regions. • Current research focuses on long term projections of risk that perpetuates high uncertainty. • Establishment of a community to generate Assessments acts to perpetuate the period of uncertainty. - Abstract: Environmental studies identify possible threats to the health of the public or the environment when the scientific certainty of risk is low, but the potential cost is high. Governments may respond by invoking the Precautionary Principle, holding that scientific certainty is not required to take actions that reduce possible risk. EU guidelines suggest that precautionary measures remain provisional until sufficient scientific certainty is generated. Here I study the Scientific Assessments produced for the Montreal Protocol, and the scientific community that generates them, and ask whether a long-standing program of scientific investigation and monitoring can generate sufficient scientific certainty to move beyond dependence on the Precautionary Principle. When the Montreal Protocol was ratified, many scientists strongly suspected that anthropogenic substances like chlorofluorocarbons were depleting stratospheric ozone. Although the risk was uncertain, the perceived cost to public health of ozone depletion was high. A quarter century after formulating the Montreal Protocol, science can define the conditions for ozone depletion with great certainty, but uncertainty remains in determining the scale and distribution of the attributable increase in damaging ultra-violet (UV) radiation. Organisations, such as NASA, and scientists that contribute to the Scientific Assessments comprise the community in which the scientific consensus of risk is

  13. Systematic Review Protocol to Assess the Effectiveness of Usability Questionnaires in mHealth App Studies.

    Science.gov (United States)

    Zhou, Leming; Bao, Jie; Parmanto, Bambang

    2017-08-01

    Usability questionnaires have a wide use in mobile health (mHealth) app usability studies. However, no systematic review has been conducted for assessing the effectiveness of these questionnaires. This paper describes a protocol for conducting a systematic review of published questionnaire-based mHealth app usability studies. In this systematic review, we will select recently published (2008-2017) articles from peer-reviewed journals and conferences that describe mHealth app usability studies and implement at least one usability questionnaire. The search strategy will include terms such as "mobile app" and "usability." Multiple databases such as PubMed, CINAHL, IEEE Xplore, ACM Digital Library, and INSPEC will be searched. There will be 2 independent reviewers in charge of screening titles and abstracts as well as determining those articles that should be included for a full-text review. The third reviewer will act as a mediator between the other 2 reviewers. Moreover, a data extraction form will be created and used during the full article data analysis. Notably, the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines will be followed in reporting this protocol. A preliminary search produced 1271 articles, 40 of which are duplicate records. The inclusion-exclusion criteria are being strictly followed in performing the ongoing study selection. Usability questionnaires are an important tool in mHealth app usability studies. This review will summarize the usability questionnaires used in published research articles while assessing the efficacy of these questionnaires in determining the usability of mHealth apps. ©Leming Zhou, Jie Bao, Bambang Parmanto. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.08.2017.

  14. Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.

    Science.gov (United States)

    Napier, A David; Nolan, John J; Bagger, Malene; Hesseldal, Louise; Volkmann, Anna-Maria

    2017-11-08

    Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through the Cities Changing Diabetes (CCD) partnership programme. A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. The protocol steers the collection of primary and secondary data across the study sites. Research ethics board approval has been sought and obtained in each site. Findings from each of the local studies as well as the result from combined multisite (global) analyses will be reported in a series of core scientific journal papers. © Article author

  15. Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence (DECIDE): protocol and preliminary results.

    Science.gov (United States)

    Treweek, Shaun; Oxman, Andrew D; Alderson, Philip; Bossuyt, Patrick M; Brandt, Linn; Brożek, Jan; Davoli, Marina; Flottorp, Signe; Harbour, Robin; Hill, Suzanne; Liberati, Alessandro; Liira, Helena; Schünemann, Holger J; Rosenbaum, Sarah; Thornton, Judith; Vandvik, Per Olav; Alonso-Coello, Pablo

    2013-01-09

    Healthcare decision makers face challenges when using guidelines, including understanding the quality of the evidence or the values and preferences upon which recommendations are made, which are often not clear. GRADE is a systematic approach towards assessing the quality of evidence and the strength of recommendations in healthcare. GRADE also gives advice on how to go from evidence to decisions. It has been developed to address the weaknesses of other grading systems and is now widely used internationally. The Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence (DECIDE) consortium (http://www.decide-collaboration.eu/), which includes members of the GRADE Working Group and other partners, will explore methods to ensure effective communication of evidence-based recommendations targeted at key stakeholders: healthcare professionals, policymakers, and managers, as well as patients and the general public. Surveys and interviews with guideline producers and other stakeholders will explore how presentation of the evidence could be improved to better meet their information needs. We will collect further stakeholder input from advisory groups, via consultations and user testing; this will be done across a wide range of healthcare systems in Europe, North America, and other countries. Targeted communication strategies will be developed, evaluated in randomized trials, refined, and assessed during the development of real guidelines. Results of the DECIDE project will improve the communication of evidence-based healthcare recommendations. Building on the work of the GRADE Working Group, DECIDE will develop and evaluate methods that address communication needs of guideline users. The project will produce strategies for communicating recommendations that have been rigorously evaluated in diverse settings, and it will support the transfer of research into practice in healthcare systems globally.

  16. 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

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

    Science.gov (United States)

    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 on decreasing preschoolers’ sedentary behavior. The ToyBox-study focuses on the prevention of overweight in 4- to 6-year-old children by implementing a multi-component kindergarten-based intervention with family involvement in six different European countries. Methods Applying the Intervention Mapping Protocol, six different steps were systematically completed for the structured planning and development of the intervention. A literature search and results from focus groups with parents/caregivers and kindergarten teachers were used as a guide during the development of the intervention and the intervention materials. Results The application of the different steps in the Intervention Mapping Protocol resulted in the creation of matrices of change objectives, followed by the selection of practical applications for five different intervention tools that could be used at the individual level of the preschool child, at the interpersonal level (i.e., parents/caregivers) and at the organizational level (i.e., kindergarten teachers). No cultural differences regarding preschoolers’ sedentary behavior were identified between the participating countries during the focus groups, so cultural and local adaptations of the intervention materials were not necessary to improve the adoption and implementation of the intervention. Conclusions A systematic and evidence-based approach was used for the development of this kindergarten-based family-involved intervention targeting preschoolers, with

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

    Science.gov (United States)

    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

    2014-02-19

    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 on decreasing preschoolers' sedentary behavior. The ToyBox-study focuses on the prevention of overweight in 4- to 6-year-old children by implementing a multi-component kindergarten-based intervention with family involvement in six different European countries. Applying the Intervention Mapping Protocol, six different steps were systematically completed for the structured planning and development of the intervention. A literature search and results from focus groups with parents/caregivers and kindergarten teachers were used as a guide during the development of the intervention and the intervention materials. The application of the different steps in the Intervention Mapping Protocol resulted in the creation of matrices of change objectives, followed by the selection of practical applications for five different intervention tools that could be used at the individual level of the preschool child, at the interpersonal level (i.e., parents/caregivers) and at the organizational level (i.e., kindergarten teachers). No cultural differences regarding preschoolers' sedentary behavior were identified between the participating countries during the focus groups, so cultural and local adaptations of the intervention materials were not necessary to improve the adoption and implementation of the intervention. A systematic and evidence-based approach was used for the development of this kindergarten-based family-involved intervention targeting preschoolers, with the inclusion of parental involvement. The

  19. Secondary school physics teachers' conceptions of scientific evidence: A collective case study

    Science.gov (United States)

    Taylor, Joseph A.

    Engaging secondary school students in inquiry-oriented tasks that more closely simulate the scholarly activities of scientists has been recommended as a way to improve scientific literacy. Two tasks that are frequently recommended include students' design of original experiments, and students' evaluation of scientific evidence and conclusions. Yet, little is known about teachers' conceptions of experimentation. The principal aim of this study, therefore, was to describe the nature of prospective and practicing physics teachers' conceptions of scientific evidence. More specifically, the following research questions guided this study: (1) What types of issues related to the measurement reliability and experimental validity of scientific evidence do practicing and prospective physics teachers think about when designing experiments? (2) When presented with hypothetical scenarios that describe unsound experimental procedures or poorly supported conclusions (or both), what concerns will prospective and practicing physics teachers raise? And (3) When the participants' responses to parallel research prompts are compared across protocols, what similarities and differences exist? The nature of the teacher-participants' conceptions was described from an analysis of data collected from research prompts such as interviews and hand written artifacts. In these research prompts, the teachers "thought aloud" while designing experiments and critically evaluated student-collected evidence presented in hypothetical classroom scenarios. The data from this study suggested that the three teachers, while contemplating the reliability and validity of scientific evidence, frequently used their conceptions of evidence in conjunction with specific subject matter conceptions. The data also indicated that the relationship between subject matter knowledge and conceptions of evidence was more pronounced for some conceptions of evidence than for others. Suggestions for future research included

  20. 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

  1. Patient profiling for success after weight loss surgery (GO Bypass study: An interdisciplinary study protocol

    Directory of Open Access Journals (Sweden)

    Bodil Just Christensen

    2018-06-01

    Full Text Available Despite substantial research efforts, the mechanisms proposed to explain weight loss after gastric bypass (RYGB and sleeve gastrectomy (SL do not explain the large individual variation seen after these treatments. A complex set of factors are involved in the onset and development of obesity and these may also be relevant for the understanding of why success with treatments vary considerably between individuals. This calls for explanatory models that take into account not only biological determinants but also behavioral, affective and contextual factors. In this prospective study, we recruited 47 women and 8 men, aged 25–56 years old, with a BMI of 45.8 ± 7.1 kg/m2 from the waiting list for RYGB and SL at Køge hospital, Denmark. Pre-surgery and 1.5, 6 and 18 months after surgery we assessed various endpoints spanning multiple domains. Endpoints were selected on basis of previous studies and include: physiological measures: anthropometrics, vital signs, biochemical measures and appetite hormones, genetics, gut microbiota, appetite sensation, food and taste preferences, neural sensitivity, sensory perception and movement behaviors; psychological measures: general psychiatric symptom-load, depression, eating disorders, ADHD, personality disorder, impulsivity, emotion regulation, attachment pattern, general self-efficacy, alexithymia, internalization of weight bias, addiction, quality of life and trauma; and sociological and anthropological measures: sociodemographic measures, eating behavior, weight control practices and psycho-social factors.Joining these many endpoints and methodologies from different scientific disciplines and creating a multi-dimensional predictive model has not previously been attempted. Data on the primary endpoint are expected to be published in 2018. Trial registration: Clinicaltrials. gov ID NCT02070081. Keywords: Gastric bypass (RYGB, Sleeve gastrectomy, Weight loss, Interdisciplinary, Study protocol

  2. Presenting evidence-based health information for people with multiple sclerosis: the IN-DEEP project protocol

    Directory of Open Access Journals (Sweden)

    Hill Sophie

    2012-03-01

    Full Text Available Abstract Background Increasingly, evidence-based health information, in particular evidence from systematic reviews, is being made available to lay audiences, in addition to health professionals. Research efforts have focused on different formats for the lay presentation of health information. However, there is a paucity of data on how patients integrate evidence-based health information with other factors such as their preferences for information and experiences with information-seeking. The aim of this project is to explore how people with multiple sclerosis (MS integrate health information with their needs, experiences, preferences and values and how these factors can be incorporated into an online resource of evidence-based health information provision for people with MS and their families. Methods This project is an Australian-Italian collaboration between researchers, MS societies and people with MS. Using a four-stage mixed methods design, a model will be developed for presenting evidence-based health information on the Internet for people with MS and their families. This evidence-based health information will draw upon systematic reviews of MS interventions from The Cochrane Library. Each stage of the project will build on the last. After conducting focus groups with people with MS and their family members (Stage 1, we will develop a model for summarising and presenting Cochrane MS reviews that is integrated with supporting information to aid understanding and decision making. This will be reviewed and finalised with people with MS, family members, health professionals and MS Society staff (Stage 2, before being uploaded to the Internet and evaluated (Stages 3 and 4. Discussion This project aims to produce accessible and meaningful evidence-based health information about MS for use in the varied decision making and management situations people encounter in everyday life. It is expected that the findings will be relevant to broader

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

    Directory of Open Access Journals (Sweden)

    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

  4. Person-centered care planning and service engagement: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Stanhope, Victoria; Tondora, Janis; Davidson, Larry; Choy-Brown, Mimi; Marcus, Steven C

    2015-04-22

    interpretation of outcomes. The aim of this study is to generate valuable guidance for state systems engaged in scale-up and transformation efforts. Targeted staff selection for training to support sustainability will serve to provide further insight into important intervention implementation strategies. Person-centered care planning has the potential to enhance the impact of all evidence-based and recovery-oriented practices and bring practice into line with the emerging national guidelines in health care reform. This trial was registered with ClinicalTrials.gov (Identifier: NCT02299492) on 21 November 2014 as New York University Protocol Record PCCP-13-9762, Person-Centered Care Planning and Service Engagement.

  5. Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST)

    NARCIS (Netherlands)

    Stott, D.J.; Gussekloo, J.; Kearney, P.M.; Rodondi, N.; Westendorp, R.G.; Mooijaart, S.; Kean, S.; Quinn, T.J.; Sattar, N.; Hendry, K.; Puy, R. Du; Elzen, W.P. den; Poortvliet, R.K.; Smit, J.W.A.; Jukema, J.W.; Dekkers, O.M.; Blum, M.; Collet, T.H.; McCarthy, V.; Hurley, C.; Byrne, S.; Browne, J.; Watt, T.; Bauer, D.; Ford, I.

    2017-01-01

    BACKGROUND: Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large

  6. Replication protocol analysis: a method for the study of real-world design thinking

    DEFF Research Database (Denmark)

    Galle, Per; Kovacs, L. B.

    1996-01-01

    ’ is refined into a method called ‘replication protocol analysis’ (RPA), and discussed from a methodological perspective of design research. It is argued that for the study of real-world design thinking this method offers distinct advantages over traditional ‘design protocol analysis’, which seeks to capture......Given the brief of an architectural competition on site planning, and the design awarded the first prize, the first author (trained as an architect but not a participant in the competition) produced a line of reasoning that might have led from brief to design. In the paper, such ‘design replication...... the designer’s authentic line of reasoning. To illustrate how RPA can be used, the site planning case is briefly presented, and part of the replicated line of reasoning analysed. One result of the analysis is a glimpse of a ‘logic of design’; another is an insight which sheds new light on Darke’s classical...

  7. The Work-It Study for people with arthritis: Study protocol and baseline sample characteristics.

    Science.gov (United States)

    Keysor, Julie J; AlHeresh, Rawan; Vaughan, Molly; LaValley, Michael P; Allaire, Saralynn

    2016-06-14

    People with arthritis are at risk of work disability. Job accommodation and educational programs delivered before imminent work loss can minimize work disability, yet are not currently being widely implemented. The Work-It Study is a randomized controlled trial testing the efficacy of a problem solving program delivered by physical and occupational therapy practitioners to prevent work loss over a two-year period among people with arthritis and rheumatological conditions. The purpose of this paper is to describe the protocol of the randomized controlled trial, and describe the baseline characteristics of the subjects and their work outcomes. 287 participants were recruited from the Boston area in Massachusetts, USA. Eligible participants were aged between 21-65, self-reported a physicians' diagnosis of arthritis, rheumatic condition, or chronic back pain, reported a concern about working now or in the near future due to your health, worked at least 15 hours a week, had plans to continue working, and worked or lived in Massachusetts. Subjects were recruited through community sources and rheumatology offices. Participants in the experimental group received a structured interview and an education and resource packet, while participants in the control received the resource packet only. The baseline characteristics and work related outcomes of the participants were analyzed. To our knowledge, the Work-It Study is the largest and most diverse randomized controlled trial to date aiming to identify and problem solve work-related barriers, promote advocacy, and foster work disability knowledge among people with chronic disabling musculoskeletal conditions. Despite advances in medical management of arthritis and other rheumatological and musculoskeletal conditions, many people still have concerns about their ability to remain employed and are seeking strategies to help them sustain employment.

  8. Reproductive studies with the anti-inflammatory agent, piroxicam: modification of classical protocols.

    Science.gov (United States)

    Perraud, J; Stadler, J; Kessedjian, M J; Monro, A M

    1984-02-14

    Reproductive toxicology studies were conducted in rabbits and rats given piroxicam, a non-steroidal anti-inflammatory agent (NSAI), orally at 2, 5 and 10 mg/kg/day. In teratology studies there was neither drug-related embryotoxicity nor teratogenicity. As piroxicam, like other NSAI, affects parturition in rats and leads to a progressive toxicity in lactating females, standard protocols were modified: dams of the female fertility study were treated from 2 weeks prior to mating until day 6 of gestation and females of the post-natal toxicity study were treated from parturition until day 12 of lactation. No other adverse effects on reproduction, fertility and postnatal development were observed.

  9. Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol.

    Science.gov (United States)

    Buttolph, Jasmine; Inwani, Irene; Agot, Kawango; Cleland, Charles M; Cherutich, Peter; Kiarie, James N; Osoti, Alfred; Celum, Connie L; Baeten, Jared M; Nduati, Ruth; Kinuthia, John; Hallett, Timothy B; Alsallaq, Ramzi; Kurth, Ann E

    2017-03-08

    Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (Pr

  10. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention

    Directory of Open Access Journals (Sweden)

    Michele R. Sgambato

    2016-08-01

    Full Text Available Abstract Background The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. Methods The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. Discussion This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. Trial registration ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.

  11. Formative research to develop theory-based messages for a Western Australian child drowning prevention television campaign: study protocol.

    Science.gov (United States)

    Denehy, Mel; Crawford, Gemma; Leavy, Justine; Nimmo, Lauren; Jancey, Jonine

    2016-05-20

    Worldwide, children under the age of 5 years are at particular risk of drowning. Responding to this need requires the development of evidence-informed drowning prevention strategies. Historically, drowning prevention strategies have included denying access, learning survival skills and providing supervision, as well as education and information which includes the use of mass media. Interventions underpinned by behavioural theory and formative evaluation tend to be more effective, yet few practical examples exist in the drowning and/or injury prevention literature. The Health Belief Model and Social Cognitive Theory will be used to explore participants' perspectives regarding proposed mass media messaging. This paper describes a qualitative protocol to undertake formative research to develop theory-based messages for a child drowning prevention campaign. The primary data source will be focus group interviews with parents and caregivers of children under 5 years of age in metropolitan and regional Western Australia. Qualitative content analysis will be used to analyse the data. This study will contribute to the drowning prevention literature to inform the development of future child drowning prevention mass media campaigns. Findings from the study will be disseminated to practitioners, policymakers and researchers via international conferences, peer and non-peer-reviewed journals and evidence summaries. The study was submitted and approved by the Curtin University Human Research Ethics Committee. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  12. Electroacupuncture to treat gastroesophageal reflux disease: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Han, Gajin; Leem, Jungtae; Lee, Hojung; Lee, Junhee

    2016-05-17

    Gastroesophageal reflux disease lowers the quality of life and increases medical costs. Electroacupuncture has been used to ease symptoms and improve gastrointestinal motility in patients with gastroesophageal reflux disease. The main purposes of this study are to evaluate the efficacy and safety of this procedure. This is a protocol for a randomized, patient-blinded, assessor-blinded, sham-controlled trial. Sixty participants with symptoms of gastroesophageal reflux disease, who have previously undergone standard treatment, will be recruited from August 2015 at Kyung Hee University Korean Medicine Hospital. The participants will be allocated to either the electroacupuncture (n = 30) or the sham electroacupuncture group (n = 30); the allocation will be concealed from both the participants and the assessors. The EA group will undergo penetrating acupuncture at 18 fixed points and two optional points chosen using the pattern identification for gastroesophageal reflux disease. Electrical stimulation will be applied at some of the acupoints. The sham electroacupuncture group will undergo nonpenetrating acupuncture without electrical stimulation at 18 nonspecific points, each of which will be only 2 cm away from the true acupoints used in the electroacupuncture group. In both groups, the procedure will be performed using the Park device. The treatment will last for 6 weeks (with two sessions each week), and the outcome will be evaluated at baseline, 3 weeks, and 6 weeks. The primary outcome will be the proportion of responders with adequate symptom relief, whereas the secondary outcomes will comprise the results of the Nepean dyspepsia index; the Korean gastrointestinal symptom rating scale; the EQ-5D™; levels of gastrin, motilin, and inflammatory cytokines; the perceived stress scale; the qi-stagnation questionnaire; the patient global impression of change; and the spleen qi deficiency questionnaire. The results of this trial will provide information

  13. An mHealth Framework to Improve Birth Outcomes in Benue State, Nigeria: A Study Protocol.

    Science.gov (United States)

    Ezeanolue, Echezona Edozie; Gbadamosi, Semiu Olatunde; Olawepo, John Olajide; Iwelunmor, Juliet; Sarpong, Daniel; Eze, Chuka; Ogidi, Amaka; Patel, Dina; Onoka, Chima

    2017-05-26

    The unprecedented coverage of mobile technology across the globe has led to an increase in the use of mobile health apps and related strategies to make health information available at the point of care. These strategies have the potential to improve birth outcomes, but are limited by the availability of Internet services, especially in resource-limited settings such as Nigeria. Our primary objective is to determine the feasibility of developing an integrated mobile health platform that is able to collect data from community-based programs, embed collected data into a smart card, and read the smart card using a mobile phone-based app without the need for Internet access. Our secondary objectives are to determine (1) the acceptability of the smart card among pregnant women and (2) the usability of the smart card by pregnant women and health facilities in rural Nigeria. We will leverage existing technology to develop a platform that integrates a database, smart card technology, and a mobile phone-based app to read the smart cards. We will recruit 300 pregnant women with one of the three conditions-HIV, hepatitis B virus infection, and sickle cell trait or disease-and four health facilities in their community. We will use Glasgow's Reach, Effectiveness, Adoption, Implementation, and Maintenance framework as a guide to assess the implementation, acceptability, and usability of the mHealth platform. We have recruited four health facilities and 300 pregnant women with at least one of the eligible conditions. Over the course of 3 months, we will complete the development of the mobile health platform and each participant will be offered a smart card; staff in each health facility will receive training on the use of the mobile health platform. Findings from this study could offer a new approach to making health data from pregnant women available at the point of delivery without the need for an Internet connection. This would allow clinicians to implement evidence

  14. 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

  15. Responding to excessive alcohol consumption in third-level (REACT): a study protocol.

    Science.gov (United States)

    Davoren, Martin P; Calnan, Susan; Mulcahy, Judith; Lynch, Emily; Perry, Ivan J; Byrne, Michael

    2018-05-11

    Problem alcohol use is an ongoing, worldwide phenomenon of considerable concern. Throughout the past 20 years, national policies have noted the importance of students when tackling alcohol consumption. Considering alcohol is a multifaceted issue, a multi-component response is required to combat its excessive use. This protocol sets out the approach used for developing, implementing and evaluating the REACT (Responding to Excessive Alcohol Consumption in Third-level) Programme. This evaluation will provide the evidence base for programme development, implementation and improvement. Stage one involved defining the multi-component intervention. This was developed following a systematic review of existing literature and a Delphi-consensus workshop involving university students, staff and relevant stakeholders. Following this, the programme is being implemented across the Higher Education sector in Ireland. A number of Higher Education Institutes have declined the invitation to participate in the programme. These institutions will act as control sites. Each intervention site will have a steering committee whose membership will include a mix of students and academic and student service staff. This steering committee will report to the REACT research team on the implementation of mandatory and optional action points at local sites. An online cross-sectional study at baseline and two-years post intervention will be utilised to determine the impact of the REACT programme. The impact assessment will focus on (1) whether the intervention has reduced alcohol consumption among third-level students (2); whether the programme altered students attitudes toward alcohol and (3) whether the programme has decreased the second-hand effects associated with excessive consumption. Finally, qualitative research will focus on factors influencing the take-up and implementation of this programme as well as students' views on the initiative. Alcohol consumption has remained on the policy

  16. Optimising conservative management of chronic low back pain: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Simson, Katherine J; Miller, Clint T; Ford, Jon; Hahne, Andrew; Main, Luana; Rantalainen, Timo; Teo, Wei-Peng; Teychenne, Megan; Connell, David; Trudel, Guy; Zheng, Guoyan; Thickbroom, Gary; Belavy, Daniel L

    2017-04-20

    Lower back pain is a global health issue affecting approximately 80% of people at some stage in their life. The current literature suggests that any exercise is beneficial for reducing back pain. However, as pain is a subjective evaluation and physical deficits are evident in low back pain, using it as the sole outcome measure to evaluate superiority of an exercise protocol for low back pain treatment is insufficient. The overarching goal of the current clinical trial is to implement two common, conservative intervention approaches and examine their impact on deficits in chronic low back pain. Forty participants, 25-45 years old with chronic (>3 months), non-specific low back pain will be recruited. Participants will be randomised to receive either motor control and manual therapy (n = 20) or general strength and conditioning (n = 20) exercise treatments for 6 months. The motor control/manual therapy group will receive twelve 30-min sessions, ten in the first 3 months (one or two per week) and two in the last 3 months. The general exercise group will attend two 1-hour sessions weekly for 3 months, and one or two a week for the following 3 months. Primary outcome measures are average lumbar spine intervertebral disc T2 relaxation time and changes in thickness of the transversus abdominis muscle on a leg lift using magnetic resonance imaging (MRI). Secondary outcomes include muscle size and fat content, vertebral body fat content, intervertebral disc morphology and water diffusion measured by MRI, body composition using dual energy X-ray absorptiometry, physical function through functional tests, changes in corticospinal excitability and cortical motor representation of the spinal muscles using transcranial magnetic stimulation and self-reported measure of pain symptoms, health and disability. Outcome measures will be conducted at baseline, at the 3-month follow-up and at 6 months at the end of intervention. Pain, depressive symptomology and emotions will be

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

    Energy Technology Data Exchange (ETDEWEB)

    Byres, E. J. [Wurldtech Research Inc., 7178 Lancrest Tr., Lantzville, BC V0R 2H0 (Canada); Huffman, D. [Wurldtech Analytics Inc., 208-1040 Hamilton St., Vancouver, BC V6B 2R9 (Canada); Kube, N. [Univ. of Victoria, Dept. of Computer Science, PO Box 3055 STN CSC, Victoria BC V8W 3P6 (Canada)

    2006-07-01

    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)

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

    International Nuclear Information System (INIS)

    Byres, E. J.; Huffman, D.; Kube, N.

    2006-01-01

    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)

  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. Automated extraction protocol for quantification of SARS-Coronavirus RNA in serum: an evaluation study

    Directory of Open Access Journals (Sweden)

    Lui Wing-bong

    2006-02-01

    Full Text Available Abstract Background We have previously developed a test for the diagnosis and prognostic assessment of the severe acute respiratory syndrome (SARS based on the detection of the SARS-coronavirus RNA in serum by real-time quantitative reverse transcriptase polymerase chain reaction (RT-PCR. In this study, we evaluated the feasibility of automating the serum RNA extraction procedure in order to increase the throughput of the assay. Methods An automated nucleic acid extraction platform using the MagNA Pure LC instrument (Roche Diagnostics was evaluated. We developed a modified protocol in compliance with the recommended biosafety guidelines from the World Health Organization based on the use of the MagNA Pure total nucleic acid large volume isolation kit for the extraction of SARS-coronavirus RNA. The modified protocol was compared with a column-based extraction kit (QIAamp viral RNA mini kit, Qiagen for quantitative performance, analytical sensitivity and precision. Results The newly developed automated protocol was shown to be free from carry-over contamination and have comparable performance with other standard protocols and kits designed for the MagNA Pure LC instrument. However, the automated method was found to be less sensitive, less precise and led to consistently lower serum SARS-coronavirus concentrations when compared with the column-based extraction method. Conclusion As the diagnostic efficiency and prognostic value of the serum SARS-CoV RNA RT-PCR test is critically associated with the analytical sensitivity and quantitative performance contributed both by the RNA extraction and RT-PCR components of the test, we recommend the use of the column-based manual RNA extraction method.

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

    Science.gov (United States)

    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

    2016-07-26

    have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society. The study protocol was registered in the database ClinicalTrials.gov on 14-06-2016 with the reference number NCT02800616 .

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

    Directory of Open Access Journals (Sweden)

    M. Willeboordse

    2016-07-01

    nature and sound scientific foundation, these integrated programmes have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society. Trial registration The study protocol was registered in the database ClinicalTrials.gov on 14-06-2016 with the reference number NCT02800616 .

  3. 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.

  4. Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED): protocol for a mixed methods feasibility study to assess the clinical utility of lower dose thyroxine in elderly hypothyroid patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wilkes, Scott; Pearce, Simon; Ryan, Vicky; Rapley, Tim; Ingoe, Lorna; Razvi, Salman

    2013-03-22

    The population of the UK is ageing. There is compelling evidence that thyroid stimulating hormone distribution levels increase with age. Currently, in UK clinical practice elderly hypothyroid patients are treated with levothyroxine to lower their thyroid stimulating hormone levels to a standard non-age-related range. Evidence suggests that mortality is negatively associated with thyroid stimulating hormone levels. We report the protocol of a feasibility study working towards a full-scale randomized controlled trial to test whether lower dose levothyroxine has beneficial cardiovascular outcomes in the oldest old. SORTED is a mixed methods study with three components: SORTED A: A feasibility study of a dual-center single-blinded randomized controlled trial of elderly hypothyroid patients currently treated with levothyroxine. Patients will be recruited from 20 general practices and two hospital trust endocrine units in Northumberland, Tyne and Wear. Target recruitment of 50 elderly hypothyroid patients currently treated with levothyroxine, identified in both primary and secondary care settings. Reduced dose of levothyroxine to achieve an elevated serum thyroid stimulating hormone (target range 4.1 to 8.0 mU/L) versus standard levothyroxine replacement (target range 0.4 to 4.0 mU/L). Using random permuted blocks, in a ratio of 1:1, randomization will be carried out by Newcastle Clinical Trials Unit. Study feasibility (recruitment and retention rates and medication compliance), acceptability of the trial design, assessment of mobility and falls risk, and change in cardiovascular risk factors. Qualitative study using in-depth interviews to understand patients' willingness to take part in a randomized controlled trial and participants' experience of the intervention. Retrospective cohort study of 400 treated hypothyroid patients aged 80 years or over registered in 2008 in primary care practices, studying their 4-year cardiovascular outcomes to inform the power of SORTED

  5. Continuous sweep versus discrete step protocols for studying effects of wearable robot assistance magnitude.

    Science.gov (United States)

    Malcolm, Philippe; Rossi, Denise Martineli; Siviy, Christopher; Lee, Sangjun; Quinlivan, Brendan Thomas; Grimmer, Martin; Walsh, Conor J

    2017-07-12

    Different groups developed wearable robots for walking assistance, but there is still a need for methods to quickly tune actuation parameters for each robot and population or sometimes even for individual users. Protocols where parameters are held constant for multiple minutes have traditionally been used for evaluating responses to parameter changes such as metabolic rate or walking symmetry. However, these discrete protocols are time-consuming. Recently, protocols have been proposed where a parameter is changed in a continuous way. The aim of the present study was to compare effects of continuously varying assistance magnitude with a soft exosuit against discrete step conditions. Seven participants walked on a treadmill wearing a soft exosuit that assists plantarflexion and hip flexion. In Continuous-up, peak exosuit ankle moment linearly increased from approximately 0 to 38% of biological moment over 10 min. Continuous-down was the opposite. In Discrete, participants underwent five periods of 5 min with steady peak moment levels distributed over the same range as Continuous-up and Continuous-down. We calculated metabolic rate for the entire Continuous-up and Continuous-down conditions and the last 2 min of each Discrete force level. We compared kinematics, kinetics and metabolic rate between conditions by curve fitting versus peak moment. Reduction in metabolic rate compared to Powered-off was smaller in Continuous-up than in Continuous-down at most peak moment levels, due to physiological dynamics causing metabolic measurements in Continuous-up and Continuous-down to lag behind the values expected during steady-state testing. When evaluating the average slope of metabolic reduction over the entire peak moment range there was no significant difference between Continuous-down and Discrete. Attempting to correct the lag in metabolics by taking the average of Continuous-up and Continuous-down removed all significant differences versus Discrete. For kinematic and

  6. 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

  7. An Outcomes Study on the Effects of the Singapore General Hospital Burns Protocol.

    Science.gov (United States)

    Liang, Weihao; Kok, Yee Onn; Tan, Bien Keem; Chong, Si Jack

    2018-01-01

    The Singapore General Hospital Burns Protocol was implemented in May 2014 to standardize treatment for all burns patients, incorporate new techniques and materials, and streamline the processes and workflow of burns management. This study aims to analyze the effects of the Burns Protocol 2 years after its implementation. Using a REDCap electronic database, all burns patients admitted from May 2013 to April 2016 were included in the study. The historical preimplementation control group composed of patients admitted from May 2013 to April 2014 (n = 96). The postimplementation prospective study cohort consisted of patients admitted from May 2014 to April 2016 (n = 243). Details of the patients collected included age, sex, comorbidities, total body surface area (TBSA) burns, time until surgery, number of surgeries, number of positive tissue and blood cultures, and length of hospital stay. There was no statistically significant difference in the demographics of both groups. The study group had a statistically significant shorter time to surgery compared with the control group (20.8 vs 38.1, P burns, was statistically significant (number of surgeries/TBSA, 0.324 vs 0.506; P = 0.0499). The study group also had significantly shorter length of stay (12.5 vs 16.8, P = 0.0273), a shorter length of stay/TBSA burns (0.874 vs 1.342, P = 0.0101), and fewer positive tissue cultures (0.6 vs 1.3, P = 0.0003). The study group also trended toward fewer positive blood culture results (0.09 vs 0.35, P = 0.0593), although the difference was just shy of statistical significance. The new Singapore General Hospital Burns Protocol had revolutionized Singapore burns care by introducing a streamlined, multidisciplinary burns management, resulting in improved patient outcomes, lowered health care costs, and improved system resource use.

  8. Grenada School Nutrition Study: Evidence to Inform Policy

    International Development Research Centre (IDRC) Digital Library (Canada)

    Grenada School Nutrition Study: Evidence to Inform ... research focusing on the main risk factors for NCDs: tobacco use, unhealthy diet, alcohol misuse, and physical inactivity. ... study predicts that non-communicable diseases associated.

  9. 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.

  10. Protocol for the evaluation and validation of Qi Blood Yin Yang deficiency pattern questionnaire: prospective observational study.

    Science.gov (United States)

    Kim, Jihye; Kim, Keun Ho

    2015-12-01

    The aim of this study is to validate the pattern identification standard of qi, blood, yin, and yang deficiency patterns diagnosis. The current study will investigate the usefulness of the Qi Blood Yin Yang deficiency pattern questionnaire as a diagnostic tool for qi, blood, yin, and yang deficiencies by assessing the agreement between the scores and a gold standard established by assessors. This protocol is for a single center, prospective, observational study. A total of 248 eligible patients with unexplained chronic fatigue will be assigned to four groups in a 1:1:1:1 ratio as the qi deficiency group, blood deficiency group, yin deficiency group, and yang deficiency group. The primary outcome will be measured using the score of the Qi Blood Yin Yang deficiency pattern questionnaire and the secondary outcomes will be measured using the fatigue severity scale, Korean-translated chalder fatigue scale, computerized tongue image analysis system, and three types of pattern identification questionnaires (cold-heat, food accumulation, and seven emotions patterns). The safety of the clinical study will be assessed after measurements at every visit. All statistical analysis will be performed using the R Statistics program. Statistics experts will analyze the relationship between clinical data using the Pearson's Chi-squared test and independent t -test. This study will provide reference data and good evidence that are applicable to future studies. Furthermore, the results of the present study are useful to improve the care of patients with unexplained chronic fatigue and unexplained chronic fatigue-related disorders.

  11. THE NEED TO STUDY PROTOCOL IN HIGHER EDUCATION STUDIES OF SOCIAL CHARACTER

    Directory of Open Access Journals (Sweden)

    Ana Belén Fernández Souto

    2013-04-01

    Full Text Available It seems clear that globalization today reaches all areas of society, business and, of course, science and knowledge. The University cannot escape this reality and should strive more than ever, to train professionals to meet the daily challenges of a weak economy and total global markets. Is in this framework in which we intend to justify the need for senior school and college students to learn and acquire training related to international protocol, so they become competent in international negotiating, to know potential communication noises that may arise interacting with different cultures and to take advantage of resources and synergies for the success of the relationship, whether or not commercial. Thus, we propose a theoretical and practical justification of why senior school students related to social area must possess protocol knowledge to leave for the labor market better prepared and to get a higher real return from its formative stage.

  12. Systems consultation: protocol for a novel implementation strategy designed to promote evidence-based practice in primary care.

    Science.gov (United States)

    Quanbeck, Andrew; Brown, Randall T; E Zgierska, Aleksandra; A Johnson, Roberta; Robinson, James M; Jacobson, Nora

    2016-01-27

    Adoption of evidence-based practices takes place at a glacial place in healthcare. This research will pilot test an innovative implementation strategy - systems consultation -intended to speed the adoption of evidence-based practice in primary care. The strategy is based on tenets of systems engineering and has been extensively tested in addiction treatment. Three innovations have been included in the strategy - translation of a clinical practice guideline into a checklist-based implementation guide, the use of physician peer coaches ('systems consultants') to help clinics implement the guide, and a focus on reducing variation in practices across prescribers and clinics. The implementation strategy will be applied to improving opioid prescribing practices in primary care, which may help ultimately mitigate the increasing prevalence of opioid abuse and addiction. The pilot test will compare four intervention clinics to four control clinics in a matched-pairs design. A leading clinical guideline for opioid prescribing has been translated into a checklist-based implementation guide in a systematic process that involved experts who wrote the guideline in consultation with implementation experts and primary care physicians. Two physicians with expertise in family and addiction medicine are serving as the systems consultants. Each systems consultant will guide two intervention clinics, using two site visits and follow-up communication by phone and email, to implement the translated guideline. Mixed methods will be used to test the feasibility, acceptability, and preliminary effectiveness of the implementation strategy in an evaluation that meets standards for 'fully developed use' of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The clinic will be the primary unit of analysis. The systems consultation implementation strategy is intended to generalize to the adoption of other clinical guidelines. This pilot test is intended to prepare

  13. 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

  14. Vertical Protocol Composition

    DEFF Research Database (Denmark)

    Groß, Thomas; Mödersheim, Sebastian Alexander

    2011-01-01

    The security of key exchange and secure channel protocols, such as TLS, has been studied intensively. However, only few works have considered what happens when the established keys are actually used—to run some protocol securely over the established “channel”. We call this a vertical protocol.......e., that the combination cannot introduce attacks that the individual protocols in isolation do not have. In this work, we prove a composability result in the symbolic model that allows for arbitrary vertical composition (including self-composition). It holds for protocols from any suite of channel and application...

  15. Optional Protocol on the Sale of Children, Child Prostitution and Child Pornography: A Study on Iran's Accession to the Protocol

    Directory of Open Access Journals (Sweden)

    Seyyed Masoud Noori

    2007-03-01

    Full Text Available Reviewing this Protocol and comparing it with Iranian law, this article seeks to respond to the question of the possible consequences of Iran's accession to the Protocol. Examining the content of the Protocol shows that Iran's accession not only is not in contrary to moral principles, the statutes and the practical procedures of Iranian Government; but it will rather promote Iranian position in the international sphere. بسیاری از پیمان‌نامه‌های مهم بین‏المللی دارای اسناد ضمیمه‌ای به نام پروتکل هستند که موضوعات سند اصلی را تشریح می‌کنند. برای کنوانسیون حقوق کودک نیز که بیش از هر سند بین‌المللی به امضای کشورها رسیده، دو پروتکل الحاقی تدوین شده است: یکی دربارة بکارگیری کودکان در مناقشات مسلّحانه و دیگری دربارة خرید و فروش، خود فروشی و هرزه‌نگاری کودکان. مجلس شورای اسلامی الحاق جمهوری اسلامی ایران به پیمان‌نامة حقوق کودک را تصویب کرده است. یکی از توصیه‌های کمیتة حقوق کودک هنگام بررسی دومین گزارش ادواری ایران این بود که ایران پروتکل‌های مذکور را تصویب کند. مجلس شورای اسلامی در جلسه 9/5/1386 الحاق دولت ایران به پروتکل مربوط به فروش، فحشاء و هرزه‌نگاری کودکان را تصویب کرده است. مقاله حاضر با مروری بر این پروتکل و مطالعة تطبیقی آن با قوانین موضوعة ایران، در صدد است این پرسش را پاسخ گوید که اجابت درخواست کمیتة حقوق کودک و امضای آن پروتکل توسط دولت ایران، چه نتایجی در

  16. Effects of a peer support programme for youth social services employees experiencing potentially traumatic events: a protocol for a prospective cohort study.

    Science.gov (United States)

    Guay, Stephane; Tremblay, Nicole; Goncalves, Jane; Bilodeau, Henriette; Geoffrion, Steve

    2017-06-24

    The use of peer support programmes to help workers experiencing potentially traumatic events (PTE) has increased in high-risk organisations in the last decades. However, the scientific evidence of its effectiveness is still very limited. This paper aims to describe the protocol of a prospective cohort study that assesses the efficacy of a peer support programme among youth social services employees exposed to a PTE at work on psychological well-being, work functioning and needs of support. This is a mixed-methods prospective study that will examine workers' evolution four times over a 12-month period in Canada. This study involves: (1) quantitative data obtained through self-administrated questionnaires among 222 workers, and (2) qualitative in-depth interviews with a subsample of 45 workers. This study will compare findings from a cohort who received the support of a peer following a PTE (peer support-experimental protocol) as part of the experimental protocol of the Montreal Youth Social Services-University Institute (MYSS-UI), the second group of workers did not ask for the peer support (no peer support-experimental protocol) but was part of MYSS-UI, and the third group received standard organisational support from the Monteregie Youth Social Services (MYSS) (standard organisational protocol). The protocol and informed consent form complied with the ethics guidelines of the MYSS-UI. The Research Ethics Board of MYSS-UI and MYSS reviewed and accepted the protocol as required. The results of the study will be published in peer-reviewed journals, presented at research and general public conferences, disseminated via a public report for the institute that funded the project and for all workers. Results of this study will influence decision making regarding intervention policies following PTE and peer support interventions may be expanded throughout the youth social services in Canada and worldwide. © Article author(s) (or their employer(s) unless otherwise stated

  17. Anorexia nervosa and cancer: a protocol for a systematic review and meta-analysis of observational studies.

    Science.gov (United States)

    Catalá-López, Ferrán; Hutton, Brian; Driver, Jane A; Ridao, Manuel; Valderas, José M; Gènova-Maleras, Ricard; Forés-Martos, Jaume; Alonso-Arroyo, Adolfo; Saint-Gerons, Diego Macías; Vieta, Eduard; Valencia, Alfonso; Tabarés-Seisdedos, Rafael

    2017-07-11

    Anorexia nervosa is characterized by a severe restriction of caloric intake, low body weight, fear of gaining weight or of becoming fat, and disturbance of body image. Pathogenesis of the disorder may include genetic predisposition, hormonal changes and a combination of environmental, psychosocial, and cultural factors. Cancer is the second leading cause of death worldwide. At present, no systematic reviews and meta-analyses have evaluated the risk of cancer in people with anorexia nervosa. The objective of this study will be to evaluate the association between anorexia nervosa and the risk of developing or dying from cancer. This study protocol is part of a systematic collection and assessment of multiple systematic reviews and meta-analyses (umbrella review) evaluating the association of cancer and multiple central nervous system disorders. We designed a specific protocol for a new systematic review and meta-analysis of observational studies of anorexia nervosa with risk of developing or dying from any cancer. Data sources will be PubMed, Embase, Scopus, Web of Science, and manual screening of references. Observational studies (case-control and cohort) in humans that examined the association between anorexia nervosa and risk of developing or dying from cancer will be sought. The primary outcomes will be cancer incidence and cancer mortality in association with anorexia nervosa. Secondary outcomes will be site-specific cancer incidence and mortality, respectively. Screening of abstracts and full texts, and data abstraction will be performed by two team members independently. Conflicts at all levels of screening and abstraction will be resolved through discussion. The quality of studies will be assessed by using the Ottawa-Newcastle scale by two team members independently. Random effects models will be conducted where appropriate. Subgroup and additional analyses will be conducted to explore the potential sources of heterogeneity. The World Cancer Research Fund

  18. Split bolus technique in polytrauma: a prospective study on scan protocols for trauma analysis

    NARCIS (Netherlands)

    Beenen, Ludo F. M.; Sierink, Joanne C.; Kolkman, Saskia; Nio, C. Yung; Saltzherr, Teun Peter; Dijkgraaf, Marcel G. W.; Goslings, J. Carel

    2015-01-01

    For the evaluation of severely injured trauma patients a variety of total body computed tomography (CT) scanning protocols exist. Frequently multiple pass protocols are used. A split bolus contrast protocol can reduce the number of passes through the body, and thereby radiation exposure, in this

  19. Translational study of obesity management using the Diabetes Prevention Program "Group Lifestyle Balance" in primary care clinics and public hospitals from Mexico: study protocol

    Directory of Open Access Journals (Sweden)

    Rolando Giovanni Díaz-Zavala

    2017-12-01

    Full Text Available Introduction: Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico. Several randomized controlled trials have shown that intensive lifestyle programs are efficacious for the management of obesity. These programs include frequent sessions (14 or more contacts in the first 6 months focused on diet and physical activity and use a behavior change protocol. However, most Mexican primary care clinics and public hospitals apply traditional treatments for obesity management with limited results on weight loss. The purpose of the study is to evaluate the effectiveness of the Diabetes Prevention Program (DPP “Group Lifestyle Balance” for weight loss among adults with overweight and obesity from baseline to 6 months and from baseline to 12 months in primary care clinics and public hospitals from Sonora, Mexico. Material and Methods: This is a translational, multi-center, non-controlled, 6 and 12-month follow-up clinical study with a pre-test and post-test design. Healthcare providers from two primary care clinics, two hospitals and one university clinic will be trained with the DPP protocol to implement on their patients with overweight and obesity. Body weight, body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life and stress scales will be measured in participants receiving the program at baseline, 6 and 12 months. Biochemical parameters will be measured at baseline and 12 months. The primary outcome is the change in body weight at 6 and 12 months. Discussion: This study will provide scientific evidence of the effectiveness of the DPP protocol as a model for obesity management in real world clinical practice among the adult Mexican population.

  20. 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

    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......Med 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...

  1. The safety of a novel early mobilization protocol conducted by ICU physicians: a prospective observational study

    Directory of Open Access Journals (Sweden)

    Keibun Liu

    2018-02-01

    Full Text Available Abstract Background There are numerous barriers to early mobilization (EM in a resource-limited intensive care unit (ICU without a specialized team or an EM culture, regarding patient stability while critically ill or in the presence of medical devices. We hypothesized that ICU physicians can overcome these barriers. The aim of this study was to investigate the safety of EM according to the Maebashi EM protocol conducted by ICU physicians. Methods This was a single-center prospective observational study. All consecutive patients with an unplanned emergency admission were included in this study, according to the exclusion criteria. The observation period was from June 2015 to June 2016. Data regarding adverse events, medical devices in place during rehabilitation, protocol adherence, and rehabilitation outcomes were collected. The primary outcome was safety. Results A total of 232 consecutively enrolled patients underwent 587 rehabilitation sessions. Thirteen adverse events occurred (2.2%; 95% confidence interval, 1.2–3.8% and no specific treatment was needed. There were no instances of dislodgement or obstruction of medical devices, tubes, or lines. The incidence of adverse events associated with mechanical ventilation or extracorporeal membrane oxygenation (ECMO was 2.4 and 3.6%, respectively. Of 587 sessions, 387 (66% sessions were performed at the active rehabilitation level, including sitting out of the bed, active transfer to a chair, standing, marching, and ambulating. ICU physicians attended over 95% of these active rehabilitation sessions. Of all patients, 143 (62% got out of bed within 2 days (median 1.2 days; interquartile range 0.1–2.0. Conclusions EM according to the Maebashi EM protocol conducted by ICU physicians, without a specialized team or EM culture, was performed at a level of safety similar to previous studies performed by specialized teams, even with medical devices in place, including mechanical ventilation or ECMO

  2. Pilot study: Assessing the effect of continual position monitoring technology on compliance with patient turning protocols

    OpenAIRE

    Schutt, Suann Cirigliano; Tarver, Christine; Pezzani, Michelle

    2017-01-01

    Abstract Aim The study aim was to evaluate if continual patient position monitoring, taking into account self‐turns and clinician‐assisted turns, would increase the percentage of time a patient's position changed at least every 2 hr. Background While patient turning has clinical benefits, current models to help staff remember to turn patients, such as “turn clocks” and timers, have not resulted in high compliance with turning protocols. In addition, reminders are based on arbitrary 2‐hr windo...

  3. Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Harvey, Allison G; Dong, Lu; Lee, Jason Y; Gumport, Nicole B; Hollon, Steven D; Rabe-Hesketh, Sophia; Hein, Kerrie; Haman, Kirsten; McNamara, Mary E; Weaver, Claire; Martinez, Armando; Notsu, Haruka; Zieve, Garret; Armstrong, Courtney C

    2017-11-14

    The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT). Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings. ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.

  4. 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

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

    Science.gov (United States)

    Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith A Y; Silburn, Sven

    2010-10-21

    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. 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. 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 Infant Simulator based programs in school settings. ISRCTN24952438.

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

    International Nuclear Information System (INIS)

    Verger, Antoine; Karcher, Gilles; Djaballah, Wassila; Fourquet, Nicolas; Rouzet, Francois; Le Guludec, Dominique; Koehl, Gregoire; Roch, Veronique; Imbert, Laetitia; Poussier, Sylvain; Fay, Renaud; Marie, Pierre-Yves

    2013-01-01

    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 201 Tl (n = 120) or 99m Tc-sestamibi injected at low dose at stress ( 99m Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ( 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, 201 Tl 92 %, 99m Tc-Low 86 %, 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 201 Tl or 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.)

  7. 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.)

  8. Grenada School Nutrition Study: Evidence to Inform Policy | CRDI ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Grenada School Nutrition Study: Evidence to Inform Policy ... LMICs can direct their efforts to changing the environments and habits that promote ... Report Card that will be suited for advocacy work, and could be used to influence policy.

  9. How safe are regional techniques? Evidence from large studies with ...

    African Journals Online (AJOL)

    meta-analysis are inappropriate for a proper assessment of rare events, such as neurological injury.2 Most of the references to adverse effects, particularly those associated with peripheral ... Evidence from large studies with big data.

  10. 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.

  11. Postpartum physiology, psychology and paediatric follow up study (P4 Study) - Study protocol.

    Science.gov (United States)

    Davis, Gregory K; Roberts, Lynne; Mangos, George; Henry, Amanda; Pettit, Franziska; O'Sullivan, Anthony; Homer, Caroline S E; Craig, Maria; Harvey, Samuel B; Brown, Mark A

    2016-10-01

    Women who have had hypertension in pregnancy are at greater risk of long term cardiovascular disease (CVD). Little is known about their cardiovascular risk postpartum or the effects on the woman's mental health and the outcomes of their infants. In this project we will study the physiological and psychological health of women and the physical health and development of their infants six months, two years and five years after birth. We will establish normal blood pressure (BP) and metabolic function for women who were normotensive in pregnancy and use these to assess women who had gestational hypertension (GH) or preeclampsia (PE). Women will be asked to participate if they have given birth in the preceding six months. They will be excluded if they had diabetes, hypertension, renal or other serious maternal disease prior to pregnancy or congenital anomaly in the pregnancy. We will recruit 292 women who were normotensive and their babies, 100 who had GH and 100 who had PE and their babies. They will be assessed at six months, two and five years after birth. At each assessment mothers will have their blood pressure (BP) assessed peripherally with a liquid crystal sphygmomanometer and 24h ambulatory blood pressure monitoring (ABPM), and centrally with non-invasive applanation tonometry. Additional physiological testing will include: body composition; energy balance; vascular compliance; cardiac function; liver and renal function, lipids and biochemistry; glucose and insulin; and urinalysis. Psychological status will be assessed with validated self-report questionnaires for depression, anxiety, post-traumatic stress disorder (PTSD) and mother-infant bonding. The babies will have a medical examination by a paediatrician at each assessment. Their behavioural development will be assessed with an Ages and Stages Questionnaire completed by their mother at each assessment and a developmental assessment by a child psychologist at two and five years. This study will re

  12. "Not just another Wii training": a graded Wii protocol to increase physical fitness in adolescent girls with probable developmental coordination disorder-a pilot study.

    Science.gov (United States)

    Bonney, Emmanuel; Rameckers, Eugene; Ferguson, Gillian; Smits-Engelsman, Bouwien

    2018-02-22

    Adolescents with low motor competence participate less in physical activity and tend to exhibit decreased physical fitness compared to their peers with high motor competence. It is therefore essential to identify new methods of enhancing physical fitness in this population. Active video games (AVG) have been shown to improve motor performance, yet investigations of its impact on physical fitness are limited. The objective of this study was to examine the impact of the graded Wii protocol in adolescent girls with probable Developmental Coordination Disorder (p-DCD). A single-group pre-post design was conducted to assess the impact of a newly developed Wii protocol in adolescent girls attending school in a low income community of Cape Town, South Africa. Sixteen participants (aged 13-16 years) with p-DCD (≤16th percentile on the MABC-2 test) were recruited. Participants received 45 min Wii training for 14 weeks. Outcome measures included the six-minute walk distance and repeated sprint ability. Information on heart rate, enjoyment and perceived exertion ratings were also collected. Significant improvements in aerobic and anaerobic fitness were observed. The participants reported high enjoyment scores and low perceived exertion ratings. The graded Wii protocol was easily adaptable and required little resources (space, equipment and expertise) to administer. The findings provide preliminary evidence to support the use of the graded Wii protocol for promoting physical fitness in adolescent girls with p-DCD. Further studies are needed to confirm these results and to validate the clinical efficacy of the protocol in a larger sample with a more robust design.

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

    Science.gov (United States)

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

    2016-06-27

    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. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. 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. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. 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.

  14. Dosimetry study comparing NCS report-2 versus IAEA TRS-398 protocol for high energy photon beams

    International Nuclear Information System (INIS)

    Attalaa, E.M.; Khaled, N.E.; Abou Elenein, H.S.; Elsayed, A.A.

    2005-01-01

    In this work a dosimetry study is presented in which the results of absorbed dose determined at reference condition according to the IAEA TRS-398 protocol and the NCS report-2 are compared. The IAEA TRS-398 protocol for absorbed dose calibration is based on ionization chamber having absorbed dose to water calibration factor N d w, while the NCS-2 dosimetry report for absorbed dose calibration is based on an ionization chamber having air- kerma calibration factor N k . This study shows that the absorbed dose which is calculated with The IAEA TRS-398 formalisms is higher than that calculated with NCS report-2 formalisms within range from 0.4 to 0.9% in cobalt-60 beam as sensed by different ionization chambers, and from 0.2 to 1.1% for different higher energy photon beams of 6, 8 and 18 MV. The chambers used are PTW 30001, 30004, and NE-2571; which have calibration factors N k and N d w traceable to the BIPM (Bureau International des Poids et Mesures)

  15. Pilot study: Assessing the effect of continual position monitoring technology on compliance with patient turning protocols.

    Science.gov (United States)

    Schutt, Suann Cirigliano; Tarver, Christine; Pezzani, Michelle

    2018-01-01

    The study aim was to evaluate if continual patient position monitoring, taking into account self-turns and clinician-assisted turns, would increase the percentage of time a patient's position changed at least every 2 hr. While patient turning has clinical benefits, current models to help staff remember to turn patients, such as "turn clocks" and timers, have not resulted in high compliance with turning protocols. In addition, reminders are based on arbitrary 2-hr windows (such as turning on "even" hours) rather than on individual patient activity, including self-turns. This is a first inpatient, non-randomized, pre-/postintervention study. Data collection occurred from May 2013-February 2014 on a 39-bed medical unit in a community hospital. Baseline patient turning data were recorded by a sensor; however, the patient data were not displayed at the nurses' station to establish compliance with the hospital's turning protocol. Postintervention, patient position information was wirelessly displayed on nurses' station computer monitors in real time. A Student t test was used to compare baseline to postintervention "mean time in compliance." Data from 138 patients ( N  =   7,854 hr of monitoring) were collected. The baseline phase yielded 4,322 hr of position monitoring data and the postintervention phase yielded 3,532 hr of data. Statistically significant improvement was demonstrated in the percentage of time a patient's position changed at least every 2 hr from baseline to postintervention.

  16. Rush allergen specific immunotherapy protocol in feline atopic dermatitis: a pilot study of four cats.

    Science.gov (United States)

    Trimmer, Ann M; Griffin, Craig E; Boord, Mona J; Rosenkrantz, Wayne S

    2005-10-01

    Rush immunotherapy has been shown to be as safe as conventional immunotherapy in canine atopic patients. Rush immunotherapy has not been reported in the feline atopic patient. The purpose of this pilot study was to determine a safe protocol for rush immunotherapy in feline atopic patients. Four atopic cats diagnosed by history, physical examination and exclusion of appropriate differential diagnoses were included in the study. Allergens were identified via liquid phase immunoenzymatic testing (VARL: Veterinary Allergy Reference Labs, Pasadena, CA). Cats were premedicated with 1.5 mg triamcinolone orally 24 and 2 h prior to first injection and 10 mg hydroxyzine PO 24, 12 and 2 h prior to first injection. An intravenous catheter was placed prior to first injection. Allergen extracts (Greer Laboratories, Lenoir, North Carolina) were all administered subcutaneously at increasing protein nitrogen units (pnu) every 30 minutes for 5 h to maintenance dose of 15,000 pnus ml-1. Vital signs were assessed every 15 minutes. Two cats developed mild pruritus and the subsequent injection was delayed 30 minutes. No changes in either cat's vital signs were noted, nor was there any further pruritus. All four cats successfully completed rush immunotherapy. Two cats developed a dermal swelling on the dorsal neck one week later. In these four cats, this protocol appeared to be a safe regimen to reach maintenance therapy. A larger sample of feline patients is needed to determine the incidence of adverse reactions and to follow the success of ASIT based upon this method of induction.

  17. Effects of a dynamic balance training protocol on podalic support in older women. Pilot Study.

    Science.gov (United States)

    Battaglia, Giuseppe; Bellafiore, Marianna; Bianco, Antonino; Paoli, Antonio; Palma, Antonio

    2010-01-01

    The foot provides the only direct contact with supporting surfaces and therefore plays an important role in all postural tasks. Changes in the musculoskeletal and neurological characteristics of the foot with advancing age can alter plantar loading patterns and postural balance. Several studies have reported that exercise training improves postural performance in elderly individuals. The aim of our study was to investigate the effectiveness of a dynamic balance training protocol performed for 5 weeks on the support surface, percentage distribution of load in both feet, and body balance performance in healthy elderly women. Ten subjects (68.67±5.50 yrs old; 28.17±3.35 BMI) were evaluated with a monopodalic performance test and baropodometric analyses before and after the training period. We found a significant improvement in balance unipedal performance times on left and right foot by 20.18% and 26.23% respectively (p0.05). The increased support surface and equal redistribution of body weight on both feet obtained in response to our training protocol may be postural adaptations sufficient to improve static balance in elderly women.

  18. Electroacupuncture for postoperative pain and gastrointestinal motility after laparoscopic appendectomy (AcuLap): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kim, Gangmi

    2015-10-14

    Acupuncture is a widely serviced complementary medicine. Although acupuncture is suggested for managing postoperative ileus and pain, supporting evidence is weak. The AcuLap trial is designed to provide high-level evidence regarding whether or not electroacupuncture is effective in promoting gastrointestinal motility and controlling pain after laparoscopic surgery. This study is a prospective randomized controlled trial with a three-arm, parallel-group structure evaluating the efficacy of electroacupuncture for gastrointestinal motility and postoperative pain after laparoscopic appendectomy. Patients with appendicitis undergoing laparoscopic surgery are included and randomized into three groups: 1) electroacupuncture group, 2) sham acupuncture group, and 3) control group. Patients receive 1) acupuncture with electrostimulation or 2) fake electroacupuncture with sham device twice a day or 3) no acupuncture after laparoscopic appendectomy. The primary outcome is time to first passing flatus after operation. Secondary outcomes include postoperative pain, analgesics, nausea/vomiting, bowel motility, time to tolerable diet, complications, hospital stay, readmission rates, time to recovery, quality of life, medical costs, and protocol failure rate. Patients and hospital staff (physicians and nurses) are blinded to which group the patient is assigned, electroacupuncture or sham acupuncture. Data analysis personnel are blinded to group assignment among all three groups. Estimated sample size to detect a minimum difference of time to first flatus with 80 % power, 5 % significance, and 10 % drop rate is 29 × 3 groups = 87 patients. Analysis will be performed according to the intention-to-treat principle. The AcuLap trial will provide evidence on the merits and/or demerits of electroacupuncture for bowel motility recovery and pain relief after laparoscopic appendectomy. The trial was registered in Clinical Research Information Service (CRiS), Republic of Korea ( KCT0001486

  19. The Physiological Bases of Hidden Noise-Induced Hearing Loss: Protocol for a Functional Neuroimaging Study.

    Science.gov (United States)

    Dewey, Rebecca Susan; Hall, Deborah A; Guest, Hannah; Prendergast, Garreth; Plack, Christopher J; Francis, Susan T

    2018-03-09

    Rodent studies indicate that noise exposure can cause permanent damage to synapses between inner hair cells and high-threshold auditory nerve fibers, without permanently altering threshold sensitivity. These demonstrations of what is commonly known as hidden hearing loss have been confirmed in several rodent species, but the implications for human hearing are unclear. Our Medical Research Council-funded program aims to address this unanswered question, by investigating functional consequences of the damage to the human peripheral and central auditory nervous system that results from cumulative lifetime noise exposure. Behavioral and neuroimaging techniques are being used in a series of parallel studies aimed at detecting hidden hearing loss in humans. The planned neuroimaging study aims to (1) identify central auditory biomarkers associated with hidden hearing loss; (2) investigate whether there are any additive contributions from tinnitus or diminished sound tolerance, which are often comorbid with hearing problems; and (3) explore the relation between subcortical functional magnetic resonance imaging (fMRI) measures and the auditory brainstem response (ABR). Individuals aged 25 to 40 years with pure tone hearing thresholds ≤20 dB hearing level over the range 500 Hz to 8 kHz and no contraindications for MRI or signs of ear disease will be recruited into the study. Lifetime noise exposure will be estimated using an in-depth structured interview. Auditory responses throughout the central auditory system will be recorded using ABR and fMRI. Analyses will focus predominantly on correlations between lifetime noise exposure and auditory response characteristics. This paper reports the study protocol. The funding was awarded in July 2013. Enrollment for the study described in this protocol commenced in February 2017 and was completed in December 2017. Results are expected in 2018. This challenging and comprehensive study will have the potential to impact diagnostic

  20. WittyFit-Live Your Work Differently: Study Protocol for a Workplace-Delivered Health Promotion.

    Science.gov (United States)

    Dutheil, Frédéric; Duclos, Martine; Naughton, Geraldine; Dewavrin, Samuel; Cornet, Thomas; Huguet, Pascal; Chatard, Jean-Claude; Pereira, Bruno

    2017-04-13

    Morbidity before retirement has a huge cost, burdening both public health and workplace finances. Multiple factors increase morbidity such as stress at work, sedentary behavior or low physical activity, and poor nutrition practices. Nowadays, the digital world offers infinite opportunities to interact with workers. The WittyFit software was designed to understand holistic issues of workers by promoting individualized behavior changes at the workplace. The shorter term feasibility objective is to demonstrate that effective use of WittyFit will increase well-being and improve health-related behaviors. The mid-term objective is to demonstrate that WittyFit improves economic data of the companies such as productivity and benefits. The ultimate objective is to increase life expectancy of workers. This is an exploratory interventional cohort study in an ecological situation. Three groups of participants will be purposefully sampled: employees, middle managers, and executive managers. Four levels of engagement are planned for employees: commencing with baseline health profiling from validated questionnaires; individualized feedback based on evidence-based medicine; support for behavioral change; and formal evaluation of changes in knowledge, practices, and health outcomes over time. Middle managers will also receive anonymous feedback on problems encountered by employees, and executive top managers will have indicators by division, location, department, age, seniority, gender and occupational position. Managers will be able to introduce specific initiatives in the workplace. WittyFit is based on two databases: behavioral data (WittyFit) and medical data (WittyFit Research). Statistical analyses will incorporate morbidity and well-being data. When a worker leaves a workplace, the company documents one of three major explanations: retirement, relocation to another company, or premature death. Therefore, WittyFit will have the ability to include mortality as an outcome

  1. Real-Time QoS Routing Protocols in Wireless Multimedia Sensor Networks: Study and Analysis.

    Science.gov (United States)

    Alanazi, Adwan; Elleithy, Khaled

    2015-09-02

    Many routing protocols have been proposed for wireless sensor networks. These routing protocols are almost always based on energy efficiency. However, recent advances in complementary metal-oxide semiconductor (CMOS) cameras and small microphones have led to the development of Wireless Multimedia Sensor Networks (WMSN) as a class of wireless sensor networks which pose additional challenges. The transmission of imaging and video data needs routing protocols with both energy efficiency and Quality of Service (QoS) characteristics in order to guarantee the efficient use of the sensor nodes and effective access to the collected data. Also, with integration of real time applications in Wireless Senor Networks (WSNs), the use of QoS routing protocols is not only becoming a significant topic, but is also gaining the attention of researchers. In designing an efficient QoS routing protocol, the reliability and guarantee of end-to-end delay are critical events while conserving energy. Thus, considerable research has been focused on designing energy efficient and robust QoS routing protocols. In this paper, we present a state of the art research work based on real-time QoS routing protocols for WMSNs that have already been proposed. This paper categorizes the real-time QoS routing protocols into probabilistic and deterministic protocols. In addition, both categories are classified into soft and hard real time protocols by highlighting the QoS issues including the limitations and features of each protocol. Furthermore, we have compared the performance of mobility-aware query based real-time QoS routing protocols from each category using Network Simulator-2 (NS2). This paper also focuses on the design challenges and future research directions as well as highlights the characteristics of each QoS routing protocol.

  2. Implementing exercise in cancer care: study protocol to evaluate a community-based exercise program for people with cancer

    OpenAIRE

    Cormie, Prue; Lamb, Stephanie; Newton, Robert U.; Valentine, Lani; McKiernan, Sandy; Spry, Nigel; Joseph, David; Taaffe, Dennis R.; Doran, Christopher M.; Galv?o, Daniel A.

    2017-01-01

    Background Clinical research has established the efficacy of exercise in reducing treatment-related side-effects and increasing wellbeing in people with cancer. Major oncology organisations have identified the importance of incorporating exercise in comprehensive cancer care but information regarding effective approaches to translating evidence into practice is lacking. This paper describes the implementation of a community-based exercise program for people with cancer and the protocol for pr...

  3. Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study.

    Science.gov (United States)

    Brehmer, Jess L; Husband, Jeffrey B

    2014-10-01

    There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation (ORIF). The purpose of this study was to compare the early postoperative outcomes (at zero to twelve weeks postoperatively) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture. We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol. From November 2007 to November 2010, eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture. Both groups began with gentle active range of motion at three to five days postoperatively. At two weeks, the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises, whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively. Patients were assessed at three to five days, two weeks, three weeks, four weeks, six weeks, eight weeks, twelve weeks, and six months postoperatively. Outcomes included Disabilities of the Arm, Shoulder and Hand (DASH) scores (primary outcome) and measurements of wrist flexion/extension, supination, pronation, grip strength, and palmar pinch. The patients in the accelerated group had better mobility, strength, and DASH scores at the early postoperative time points (zero to eight weeks postoperatively) compared with the patients in the standard rehabilitation group. The difference between the groups was both clinically relevant and statistically significant. Patients who follow an accelerated rehabilitation

  4. Abdominal stab wound protocol: prospective study documents applicability for widespread use.

    Science.gov (United States)

    Rosemurgy, A S; Albrink, M H; Olson, S M; Sherman, H; Albertini, J; Kramer, R; Camps, M; Reiss, A

    1995-02-01

    Traditionally, stab wounds violating the abdominal wall fascia led to exploratory celiotomy that was often nontherapeutic. In an attempt to limit the number of nontherapeutic celiotomies (NTC), we devised a protocol to prospectively study stab wounds violating the anterior abdominal wall fascia. Through protocol, abdominal stab wounds were explored in stable adults. If the anterior fascia was violated, paracentesis and, if necessary, peritoneal lavage was undertaken in the absence of previous abdominal surgery. If evisceration was noted, it was reduced and the patient lavaged. Fascial penetration was noted in 72 patients. 46 patients underwent celiotomy: because of shock/peritonitis in 8 (2 NTC), fascial penetration with a history of previous celiotomy in 7 (5 NTC), positive paracentesis in 20 (5 NTC), or positive lavage in 10 (4 NTC). One patient underwent late celiotomy without ill-effect after a negative lavage because she subsequently developed fever and localized peritonitis (ice pick injury to cecum). Eleven patients had evisceration; nine underwent celiotomy. Patients with abdominal stab wounds can be selectively managed safely. More than one-third with fascial penetration, some with evisceration, avoided exploration. Only one patient underwent delayed celiotomy and did so without detriment. Nontherapeutic celiotomy rates were highest in patients with previous abdominal surgery who, thereby, could not undergo paracentesis/lavage; excluding these patients, the nontherapeutic celiotomy rate was 17% (11/65) for those with fascial penetration.

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

    Science.gov (United States)

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

    2016-06-10

    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. The development of this intervention is based on the Intervention Mapping (IM) protocol, which starts from a needs assessment, uses theory and empirical research to develop a detailed intervention plan, and anticipates program implementation and evaluation. This novel intervention targets first year students in preparatory secondary vocational education (11-13 years of age). Teachers are the program implementers. One part of the intervention involves a 30 % increase of strength exercises in the physical education lessons. The other part is based on Motivational Interviewing, promoting autonomous motivation of students to become more physically active outside school. Performance and change objectives are described for both teachers and students. The effectiveness of the intervention will be tested in a Randomized Controlled Trial in 9 Dutch high schools. Intervention Mapping is a useful framework for program planning a school-based program to improve body composition and motivation to exercise in 11-13 year old adolescents by a "Focus on Strength". NTR5676 , registered 8 February 2016 (retrospectively registered).

  6. Toward a New Process-Based Indicator for Measuring Writing Fluency: Evidence from L2 Writers' Think-Aloud Protocols

    Science.gov (United States)

    Abdel Latif, Muhammad M.

    2009-01-01

    This article reports on a study aimed at testing the hypothesis that, because of strategic and temporal variables, composing rate and text quantity may not be valid measures of writing fluency. A second objective was to validate the mean length of writers' translating episodes as a process-based indicator that mirrors their fluent written…

  7. Study protocol: imaging brain development in the Childhood to Adolescence Transition Study (iCATS).

    Science.gov (United States)

    Simmons, Julian G; Whittle, Sarah L; Patton, George C; Dudgeon, Paul; Olsson, Craig; Byrne, Michelle L; Mundy, Lisa K; Seal, Marc L; Allen, Nicholas B

    2014-04-30

    Puberty is a critical developmental phase in physical, reproductive and socio-emotional maturation that is associated with the period of peak onset for psychopathology. Puberty also drives significant changes in brain development and function. Research to date has focused on gonadarche, driven by the hypothalamic-pituitary-gonadal axis, and yet increasing evidence suggests that the earlier pubertal stage of adrenarche, driven by the hypothalamic-pituitary-adrenal axis, may play a critical role in both brain development and increased risk for disorder. We have established a unique cohort of children who differ in their exposure to adrenarcheal hormones. This presents a unique opportunity to examine the influence of adrenarcheal timing on brain structural and functional development, and subsequent health outcomes. The primary objective of the study is to explore the hypothesis that patterns of structural and functional brain development will mediate the relationship between adrenarcheal timing and indices of affect, self-regulation, and mental health symptoms collected across time (and therefore years of development). Children were recruited based upon earlier or later timing of adrenarche, from a larger cohort, with 128 children (68 female; M age 9.51 years) and one of their parents taking part. Children completed brain MRI structural and functional sequences, provided saliva samples for adrenarcheal hormones and immune biomarkers, hair for long-term cortisol levels, and completed questionnaires, anthropometric measures and an IQ test. Parents completed questionnaires reporting on child behaviour, development, health, traumatic events, and parental report of family environment and parenting style. This study, by examining the neurobiological and behavioural consequences of relatively early and late exposure to adrenarche, has the potential to significantly impact our understanding of pubertal risk processes.

  8. 'Communicate to vaccinate' (COMMVAC. building evidence for improving communication about childhood vaccinations in low- and middle-income countries: protocol for a programme of research

    Directory of Open Access Journals (Sweden)

    Lewin Simon

    2011-12-01

    Full Text Available Abstract Background Effective provider-parent communication can improve childhood vaccination uptake and strengthen immunisation services in low- and middle-income countries (LMICs. Building capacity to improve communication strategies has been neglected. Rigorous research exists but is not readily found or applicable to LMICs, making it difficult for policy makers to use it to inform vaccination policies and practice. The aim of this project is to build research knowledge and capacity to use evidence-based strategies for improving communication about childhood vaccinations with parents and communities in LMICs. Methods and design This project is a mixed methods study with six sub-studies. In sub-study one, we will develop a systematic map of provider-parent communication interventions for childhood vaccinations by screening and extracting data from relevant literature. This map will inform sub-study two, in which we will develop a taxonomy of interventions to improve provider-parent communication around childhood vaccination. In sub-study three, the taxonomy will be populated with trial citations to create an evidence map, which will also identify how evidence is linked to communication barriers regarding vaccination. In the project's fourth sub-study, we will present the interventions map, taxonomy, and evidence map to international stakeholders to identify high-priority topics for systematic reviews of interventions to improve parent-provider communication for childhood vaccination. We will produce systematic reviews of the effects of high-priority interventions in the fifth sub-study. In the sixth and final sub-study of the project, evidence from the systematic reviews will be translated into accessible formats and messages for dissemination to LMICs. Discussion This project combines evidence mapping, conceptual and taxonomy development, priority setting, systematic reviews, and knowledge transfer. It will build and share concepts, terms

  9. Beyond protocols

    DEFF Research Database (Denmark)

    Vanderhoeven, Sonia; Branquart, Etienne; Casaer, Jim

    2017-01-01

    Risk assessment tools for listing invasive alien species need to incorporate all available evidence and expertise. Beyond the wealth of protocols developed to date, we argue that the current way of performing risk analysis has several shortcomings. In particular, lack of data on ecological impact...... information on risk and the exploration of improved methods for decision making on biodiversity management. This is crucial for efficient conservation resource allocation and uptake by stakeholders and the public......., transparency and repeatability of assessments as well as the incorporation of uncertainty should all be explicitly considered. We recommend improved quality control of risk assessments through formalized peer review with clear feedback between assessors and reviewers. Alternatively, a consensus building...

  10. When general practitioners meet new evidence: an exploratory ethnographic study.

    Science.gov (United States)

    Olsen, Ole

    2017-12-01

    To explore how general practitioners (GPs) think and act when presented with new evidence in relation to planned home birth and a proposal to change information practices. Exploratory ethnographic study of GPs. The GPs were encountered one or more times during a two-year period, 2011-2013, while the author tried to set up formal focus group interviews. Dialogues about the evidence, personal experiences, values and other issues unavoidably occurred. Field notes were written concomitantly. Danish GPs, primarily in Copenhagen. Fifty Danish GPs. The GPs reacted very differently, both spontaneously and later. Spontaneous reactions were often emotional involving private and professional experiences whereas later reactions were more influenced by rational deliberations. Approximately half the GPs (n = 18) who were asked whether they would personally hand out the local information leaflet about home birth were prepared to do so. The time lag between presentation of the evidence and the GPs' decision to hand out the leaflets was up to one and a half year. A significant number of GPs were prepared to change their information practices. However, for many GPs, the new evidence challenged previous perceptions, and ample time and resources for dialogue, deliberations and adaptation to local circumstances were required to accommodate change. Changing information practices on a larger scale will require a systematic approach involving key stakeholders. Key Points Current awareness•Patients and pregnant women should receive evidence-based information about possible choices of care - also in relation to place of birth. Most important results•Doctors often find the new evidence supporting planned home birth counterintuitive and spontaneously react emotionally rather than rationally to the evidence.•The new evidence challenging previous views elicits fast, emotional reactions, later deliberate reflections, perhaps cognitive dissonance and, finally, for some, change in

  11. A randomized controlled trial of culturally adapted motivational interviewing for Hispanic heavy drinkers: Theory of Adaptation and Study Protocol

    Science.gov (United States)

    Lee, Christina S.; Colby, Suzanne M.; Magill, Molly; Almeida, Joanna; Tavares, Tonya; Rohsenow, Damaris J.

    2016-01-01

    Background The NIH Strategic Plan prioritizes health disparities research for socially disadvantaged Hispanics, to reduce the disproportionate burden of alcohol-related negative consequences compared to other racial/ethnic groups. Cultural adaptation of evidence-based treatments, such as motivational interviewing (MI), can improve access and response to alcohol treatment. However, the lack of rigorous clinical trials designed to test the efficacy and theoretical underpinnings of cultural adaptation has made proof of concept difficult. Objective The CAMI2 (Culturally Adapted Motivational Interviewing) study design and its theoretical model, is described to illustrate how MI adapted to social and cultural factors (CAMI) can be discriminated against non-adapted MI. Methods and Design CAMI2, a large, 12 month randomized prospective trial, examines the efficacy of CAMI and MI among heavy drinking Hispanics recruited from the community (n=257). Outcomes are reductions in heavy drinking days (Time Line Follow-Back) and negative consequences of drinking among Hispanics (Drinkers Inventory of Consequences). A second aim examines perceived acculturation stress as a moderator of treatment outcomes in the CAMI condition. Summary The CAMI2 study design protocol is presented and the theory of adaptation is presented. Findings from the trial described may yield important recommendations on the science of cultural adaptation and improve MI dissemination to Hispanics with alcohol risk. PMID:27565832

  12. The effects of reminiscence therapy on depressive symptoms of Chinese elderly: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Ting-ji

    2012-11-01

    Full Text Available Abstract Background Depression is one of the most common mental disorders with a high prevalence among the older adults. In recent years, after realizing some side effects of the antidepressants, non-pharmacological psychological treatments begin to attract accruing attention. Reminiscence therapy is one of the psychological treatments that specially designed for the elderly to improve their mental health status by recalling and assessing their existing memory. Though some studies indicate reminiscence therapy can be effective and beneficial for the mental health of elderly, the conclusions are not consistent yet. The aim of this research is to assess the effectiveness of reminiscence therapy for Chinese elderly. Methods Sixty older adults (≥60 years of age with mild to moderate depression will be randomly assigned to an experimental or a control condition. The participants in the experiment group will receive the reminiscence therapy under the Watt’s protocol with adaptation to Chinese Culture which consists of six weekly sessions of 90 minutes each. The control group will be treated as before. An assessor who is blind to intervention will conduct the measures before treatment, after treatment immediately, and three months after treatment. Discussion This study will provide the evidence whether the reminiscence therapy is effective to treat depressive symptoms of Chinese elderly. This research has been registered in the clinicaltrials.gov (NCT01553669.

  13. Mortality in Transition: Study Protocol of the PrivMort Project, a multilevel convenience cohort study

    Directory of Open Access Journals (Sweden)

    Darja Irdam

    2016-07-01

    Full Text Available Abstract Background Previous research using routine data identified rapid mass privatisation as an important driver of mortality crisis following the collapse of Communism in Central and Eastern Europe. However, existing studies on the mortality crisis relying on individual level or routine data cannot assess both distal (societal and proximal (individual causes of mortality simultaneously. The aim of the PrivMort Project is to overcome these limitations and to investigate the role of societal factors (particularly rapid mass privatisation and individual-level factors (e.g. alcohol consumption in the mortality changes in post-communist countries. Methods The PrivMort conducts large-sample surveys in Russia, Belarus and Hungary. The approach is unique in comparing towns that have undergone rapid privatisation of their key industrial enterprises with those that experienced more gradual forms of privatisation, employing a multi-level retrospective cohort design that combines data on the industrial characteristics of the towns, socio-economic descriptions of the communities, settlement-level data, individual socio-economic characteristics, and individuals’ health behaviour. It then incorporates data on mortality of different types of relatives of survey respondents, employing a retrospective demographic approach, which enables linkage of historical patterns of mortality to exposures, based on experiences of family members. By May 2016, 63,073 respondents provided information on themselves and 205,607 relatives, of whom 102,971 had died. The settlement-level dataset contains information on 539 settlements and 12,082 enterprises in these settlements in Russia, 96 settlements and 271 enterprises in Belarus, and 52 settlement and 148 enterprises in Hungary. Discussion In addition to reinforcing existing evidence linking smoking, hazardous drinking and unemployment to mortality, the PrivMort dataset will investigate the variation in transition

  14. Mortality in Transition: Study Protocol of the PrivMort Project, a multilevel convenience cohort study.

    Science.gov (United States)

    Irdam, Darja; King, Lawrence; Gugushvili, Alexi; Azarova, Aytalina; Fazekas, Mihaly; Scheiring, Gabor; Stefler, Denes; Doniec, Katarzyna; Horvat, Pia; Kolesnikova, Irina; Popov, Vladimir; Szelenyi, Ivan; Marmot, Michael; Murphy, Michael; McKee, Martin; Bobak, Martin

    2016-07-30

    Previous research using routine data identified rapid mass privatisation as an important driver of mortality crisis following the collapse of Communism in Central and Eastern Europe. However, existing studies on the mortality crisis relying on individual level or routine data cannot assess both distal (societal) and proximal (individual) causes of mortality simultaneously. The aim of the PrivMort Project is to overcome these limitations and to investigate the role of societal factors (particularly rapid mass privatisation) and individual-level factors (e.g. alcohol consumption) in the mortality changes in post-communist countries. The PrivMort conducts large-sample surveys in Russia, Belarus and Hungary. The approach is unique in comparing towns that have undergone rapid privatisation of their key industrial enterprises with those that experienced more gradual forms of privatisation, employing a multi-level retrospective cohort design that combines data on the industrial characteristics of the towns, socio-economic descriptions of the communities, settlement-level data, individual socio-economic characteristics, and individuals' health behaviour. It then incorporates data on mortality of different types of relatives of survey respondents, employing a retrospective demographic approach, which enables linkage of historical patterns of mortality to exposures, based on experiences of family members. By May 2016, 63,073 respondents provided information on themselves and 205,607 relatives, of whom 102,971 had died. The settlement-level dataset contains information on 539 settlements and 12,082 enterprises in these settlements in Russia, 96 settlements and 271 enterprises in Belarus, and 52 settlement and 148 enterprises in Hungary. In addition to reinforcing existing evidence linking smoking, hazardous drinking and unemployment to mortality, the PrivMort dataset will investigate the variation in transition experiences for individual respondents and their families across

  15. Alcohol prevention at sporting events: study protocol for a quasi-experimental control group study

    Directory of Open Access Journals (Sweden)

    Natalie Durbeej

    2016-06-01

    Full Text Available Abstract Background Alcohol intoxication and overserving of alcohol at sporting events are of great concern, given the relationships between alcohol consumption, public disturbances, and violence. During recent years this matter has been on the agenda for Swedish policymakers, authorities and key stakeholders, with demands that actions be taken. There is promising potential for utilizing an environmental approach to alcohol prevention as a strategy to reduce the level of alcohol intoxication among spectators at sporting events. Examples of prevention strategies may be community mobilization, Responsible Beverage Service training, policy work, and improved controls and sanctions. This paper describes the design of a quasi-experimental control group study to examine the effects of a multi-component community-based alcohol intervention at matches in the Swedish Premier Football League. Methods A baseline assessment was conducted during 2015 and at least two follow-up assessments will be conducted in 2016 and 2017. The two largest cities in Sweden are included in the study, with Stockholm as the intervention area and Gothenburg as the control area. The setting is Licensed Premises (LP inside and outside Swedish football arenas, in addition to arena entrances. Spectators are randomly selected and invited to participate in the study by providing a breath alcohol sample as a proxy for Blood Alcohol Concentration (BAC. Actors are hired and trained by an expert panel to act out a standardized scene of severe pseudo-intoxication. Four types of cross-sectional data are generated: (i BAC levels among ≥ 4 200 spectators, frequency of alcohol service to pseudo-intoxicated patrons attempting to purchase alcohol at LP (ii outside the arenas (≥200 attempts and (iii inside the arenas (≥ 200 attempts, and (iv frequency of security staff interventions towards pseudo-intoxicated patrons attempting to enter the arenas (≥ 200 attempts. Discussion There

  16. Effects of herbal medicine for dysmenorrhea treatment on accompanied acne vulgaris: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kim, Kwan-Il; Nam, Hae Jeong; Kim, Mia; Lee, Junhee; Kim, Kyuseok

    2017-06-17

    The incidence of preadolescent acne among women is increasing. Acne deteriorates the quality of life; conventional treatment options are limited and have not been effective against acne, particularly acne associated with menstruation. Despite evidence that acne associated with menstruation abnormalities naturally improves when menstruation recovers to normal, there have only been few studies on the effects of dysmenorrhea treatment on acne. Therefore- we designed this study to assess the effects of gyejibokryung-hwan (GBH) and dangguijagyag-san (DJS), which are widely used in dysmenorrhea treatment, on acne associated with menstruation cycle. This is a protocol for a randomized, double-blind, parallel-group, placebo-controlled and multicenter trial. One hundred and sixteen participants with dysmenorrhea accompanied by acne vulgaris will be recruited at three centers and randomized into two groups, the herbal treatment group and placebo group. The participants will receive GBH or DJS based on pattern identification or placebo granules thrice daily for 8 weeks, with an 8-week follow up. The primary outcome will be the mean percentage change in the count of inflammatory acne lesions. The secondary outcomes would be based on dysmenorrhea numeric rating scale, verbal multidimensional scoring system for dysmenorrhea, acne numeric rating scale, investigator's static global assessment scale of facial acne vulgaris, and safety testing. Adverse events will also be reported. The effects of GBH or DJS used in dysmenorrhea treatment on acne associated with the menstrual cycle will be evaluated. The findings of this trial will provide evidence regarding the effect of herbal medicine in improving acne vulgaris associated with menstruation in women. Korean Clinical Trial Registry ( http://cris.nih.go.kr ; registration number: KCT0002259). Date of registration: March 10, 2017.

  17. Music in mind, a randomized controlled trial of music therapy for young people with behavioural and emotional problems: study protocol.

    Science.gov (United States)

    Porter, Sam; Holmes, Valerie; McLaughlin, Katrina; Lynn, Fiona; Cardwell, Chris; Braiden, Hannah-Jane; Doran, Jackie; Rogan, Sheelagh

    2012-10-01

    This article is a report of a trial protocol to determine if improvizational music therapy leads to clinically significant improvement in communication and interaction skills for young people experiencing social, emotional or behavioural problems. Music therapy is often considered an effective intervention for young people experiencing social, emotional or behavioural difficulties. However, this assumption lacks empirical evidence. Music in mind is a multi-centred single-blind randomized controlled trial involving 200 young people (aged 8-16 years) and their parents. Eligible participants will have a working diagnosis within the ambit of international classification of disease 10 mental and behavioural disorders and will be recruited over 15 months from six centres within the Child and Adolescent Mental Health Services of a large health and social care trust in Northern Ireland. Participants will be randomly allocated in a 1:1 ratio to receive standard care alone or standard care plus 12 weekly music therapy sessions delivered by the Northern Ireland Music Therapy Trust. Baseline data will be collected from young people and their parents using standardized outcome measures for communicative and interaction skills (primary endpoint), self-esteem, social functioning, depression and family functioning. Follow-up data will be collected 1 and 13 weeks after the final music therapy session. A cost-effectiveness analysis will also be carried out. This study will be the largest trial to date examining the effect of music therapy on young people experiencing social, emotional or behavioural difficulties and will provide empirical evidence for the use of music therapy among this population. Trial registration. This study is registered in the ISRCTN Register, ISRCTN96352204. Ethical approval was gained in October 2010. © 2012 Blackwell Publishing Ltd.

  18. Balancing nurses' workload in hospital wards: study protocol of developing a method to manage workload.

    Science.gov (United States)

    van den Oetelaar, W F J M; van Stel, H F; van Rhenen, W; Stellato, R K; Grolman, W

    2016-11-10

    Hospitals pursue different goals at the same time: excellent service to their patients, good quality care, operational excellence, retaining employees. This requires a good balance between patient needs and nursing staff. One way to ensure a proper fit between patient needs and nursing staff is to work with a workload management method. In our view, a nursing workload management method needs to have the following characteristics: easy to interpret; limited additional registration; applicable to different types of hospital wards; supported by nurses; covers all activities of nurses and suitable for prospective planning of nursing staff. At present, no such method is available. The research follows several steps to come to a workload management method for staff nurses. First, a list of patient characteristics relevant to care time will be composed by performing a Delphi study among staff nurses. Next, a time study of nurses' activities will be carried out. The 2 can be combined to estimate care time per patient group and estimate the time nurses spend on non-patient-related activities. These 2 estimates can be combined and compared with available nursing resources: this gives an estimate of nurses' workload. The research will take place in an academic hospital in the Netherlands. 6 surgical wards will be included, capacity 15-30 beds. The study protocol was submitted to the Medical Ethical Review Board of the University Medical Center (UMC) Utrecht and received a positive advice, protocol number 14-165/C. This method will be developed in close cooperation with staff nurses and ward management. The strong involvement of the end users will contribute to a broader support of the results. The method we will develop may also be useful for planning purposes; this is a strong advantage compared with existing methods, which tend to focus on retrospective analysis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence

  19. Developing protocols for geochemical baseline studies: An example from the Coles Hill uranium deposit, Virginia, USA

    International Nuclear Information System (INIS)

    Levitan, Denise M.; Schreiber, Madeline E.; Seal, Robert R.; Bodnar, Robert J.; Aylor, Joseph G.

    2014-01-01

    Highlights: • We outline protocols for baseline geochemical surveys of stream sediments and water. • Regression on order statistics was used to handle non-detect data. • U concentrations in stream water near this unmined ore were below regulatory standards. • Concentrations of major and trace elements were correlated with stream discharge. • Methods can be applied to other extraction activities, including hydraulic fracturing. - Abstract: In this study, we determined baseline geochemical conditions in stream sediments and surface waters surrounding an undeveloped uranium deposit. Emphasis was placed on study design, including site selection to encompass geological variability and temporal sampling to encompass hydrological and climatic variability, in addition to statistical methods for baseline data analysis. The concentrations of most elements in stream sediments were above analytical detection limits, making them amenable to standard statistical analysis. In contrast, some trace elements in surface water had concentrations that were below the respective detection limits, making statistical analysis more challenging. We describe and compare statistical methods appropriate for concentrations that are below detection limits (non-detect data) and conclude that regression on order statistics provided the most rigorous analysis of our results, particularly for trace elements. Elevated concentrations of U and deposit-associated elements (e.g. Ba, Pb, and V) were observed in stream sediments and surface waters downstream of the deposit, but concentrations were below regulatory guidelines for the protection of aquatic ecosystems and for drinking water. Analysis of temporal trends indicated that concentrations of major and trace elements were most strongly related to stream discharge. These findings highlight the need for sampling protocols that will identify and evaluate the temporal and spatial variations in a thorough baseline study

  20. Effect of single family rooms for preterm infants on neurodevelopment: study protocol for a systematic review.

    Science.gov (United States)

    van Veenendaal, Nicole R; van der Schoor, Sophie R D; Limpens, Jacqueline; van Kempen, Anne A M W; van Goudoever, Johannes B

    2017-08-04

    Preterm infants are at an increased risk for neurodevelopmental delay. They have to endure many stressors in early life, including parent-infant separation, noise and painful procedures during hospitalisation in the highly technological environment of the modern neonatal ward. Currently, a shift is being noticed in the architectural design of neonatal wards towards single family rooms instead of the common open bay units. The influence of the hospital environment on health and specifically neurodevelopment in this vulnerable patient population remains under discussion. To assess the effect of single family rooms during hospitalisation primarily on neurodevelopment in preterm infants. Secondary outcome measures will be neonatal (ie, breastfeeding rates, sepsis, growth during hospital stay, length of hospital stay) and parental (ie, parental stress, satisfaction, participation, presence and self-efficacy). The PRISMA-P 2015 (Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015) 17 items checklist was used for the generation of the protocol for this review. The following PICO was formulated: Population: preterm infants with need of hospitalisation in the neonatal ward; Intervention: single family rooms; Comparison: standard neonatal care in open bay units; Outcome: neurodevelopmental outcome of infants from 9 months onwards. If at least two studies, with low or moderate risk of bias, suitable for inclusion are found a meta-analysis will be performed. If quantitative synthesis is not appropriate the data will be presented descriptively. This will be the first review, systematically assessing the effect of single family rooms on neurodevelopmental outcome in preterm infants. Clinical practice could possibly be optimised to ameliorate neurodevelopment in this vulnerable patient population based on these insights. This systematic review will be published in an international peer-reviewed journal. We registered this systematic review

  1. Nationwide cross-sectional survey of schistosomiasis and soil-transmitted helminthiasis in Sudan: study protocol.

    Science.gov (United States)

    Cha, Seungman; Hong, Sung-Tae; Lee, Young-Ha; Lee, Keon Hoon; Cho, Dae Seong; Lee, Jinmoo; Chai, Jong-Yil; Elhag, Mousab Siddig; Khaled, Soheir Gabralla Ahmad; Elnimeiri, Mustafa Khidir Mustafa; Siddig, Nahid Abdelgadeir Ali; Abdelrazig, Hana; Awadelkareem, Sarah; Elshafie, Azza Tag Eldin; Ismail, Hassan Ahmed Hassan Ahmed; Amin, Mutamad

    2017-09-12

    Schistosomiasis and soil-transmitted helminthiasis (STHs) are target neglected tropical diseases (NTDs) of preventive chemotherapy, but the control and elimination of these diseases have been impeded due to resource constraints. Few reports have described study protocol to draw on when conducting a nationwide survey. We present a detailed methodological description of the integrated mapping of schistosomiasis and STHs on the basis of our experiences, hoping that this protocol can be applied to future surveys in similar settings. In addition to determining the ecological zones requiring mass drug administration interventions, we aim to provide precise estimates of the prevalence of these diseases. A school-based cross-sectional design will be applied for the nationwide survey across Sudan. The survey is designed to cover all districts in every state. We have divided each district into 3 different ecological zones depending on proximity to bodies of water. We will employ a probability-proportional-to-size sampling method for schools and systematic sampling for student selection to provide adequate data regarding the prevalence for schistosomiasis and STHs in Sudan at the state level. A total of 108,660 students will be selected from 1811 schools across Sudan. After the survey is completed, 391 ecological zones will be mapped out. To carry out the survey, 655 staff members were recruited. The feces and urine samples are microscopically examined by the Kato-Katz method and the sediment smears for helminth eggs respectively. For quality control, a minimum of 10% of the slides will be rechecked by the federal supervisors in each state and also 5% of the smears are validated again within one day by independent supervisors. This nationwide mapping is expected to generate important epidemiological information and indicators about schistosomiasis and STHs that will be useful for monitoring and evaluating the control program. The mapping data will also be used for overviewing

  2. A comparative study of biological and metabolic biomarkers between healthy individuals and patients with acne vulgaris: A cross-sectional study protocol.

    Science.gov (United States)

    Kim, Kyuseok; Ha, Injin; Kim, Eunok; Kim, Kyunglee

    2017-11-01

    Acne is a multifactorial dermatosis, which is influenced not only by hormones but also by the biochemical relationship between them and the pilosebaceous unit. Inflammatory cytokines, chemokines, active oxygen, and zinc are known to be associated with the development of acne. Further, steroid metabolism is known as one of the important factors related to sebum secretion and comedone formation in acne. However, there is a lack of studies comparing these human biomarkers between healthy individuals and patients with acne. In particular, no study has investigated the relationship between human biomarkers and patterns of acne yet.The purpose of this study is to investigate diagnostic human biomarkers in acne by comparing the biological and metabolic biomarkers between healthy individuals and patients with acne and identify the relationship between human biomarkers and patterns of acne.This study is a protocol for a cross-sectional study. Forty healthy participants and 60 patients with acne will be recruited at 1 center. We will collect their blood samples and analyze the molecular biological and metabolic biomarkers (cytokines, chemokines, reactive oxygen species, corticotropin-releasing hormone, zinc, amino acid, 1-carbon metabolite, lipid metabolite, etc.). Further, we will administer questionnaires regarding their diet, sleep, stress, and other factors relating to acne and measure their skin elasticity.The study protocol was approved by the Institutional Review Board of Oriental Medical Hospital at Kyung Hee Medical Center (KOMCIRB-161118-HR-062). Written informed consent will be obtained from all the participants. The trial was registered in the Clinical Research Information Service, Republic of Korea: KCT0002212.This trial will provide evidence regarding diagnostic human biomarkers in acne and the relationship between the human biomarkers and patterns of acne.

  3. Recall of intensive care unit stay in patients managed with a sedation protocol or a sedation protocol with daily sedative interruption: a pilot study.

    Science.gov (United States)

    Ethier, Cheryl; Burry, Lisa; Martinez-Motta, Carlos; Tirgari, Sam; Jiang, Depeng; McDonald, Ellen; Granton, John; Cook, Deborah; Mehta, Sangeeta

    2011-04-01

    Analgesics and sedatives are integral for the relief of pain and anxiety in critically ill patients. However, these agents may contribute to amnesia for intensive care unit (ICU) events; which has been associated with development of posttraumatic stress disorder. Drug administration strategies that minimize sedative use have been associated with less amnesia. The objective of this pilot study was to evaluate recall of ICU stay in patients managed with 2 sedation strategies: a sedation protocol or a combination of sedation protocol and daily sedative/analgesic interruption. A questionnaire was administered on day 3 following ICU discharge to evaluate patients' recollections of pain, anxiety, fear, and sleep, as well as memories for specific ICU procedures. Participants were ICU survivors who had been enrolled in SLEAP - a randomized pilot trial comparing two sedation strategies, at 3 university-affiliated medical/surgical ICUs. Twenty-one patients who regained orientation within 72 hours of ICU discharge completed the questionnaire. More than 50% of patients recalled experiencing pain, anxiety, and fear to a moderate or extreme extent; and 57% reported inadequate sleep while in the ICU. Of the 21 patients, 48%, 33%, and 29% had no memories of endotracheal tube suctioning, being on a "breathing machine," and being bathed, respectively. A notable percentage of patients discharged from the ICU report moderate to extreme pain, anxiety, and fear, and inability to sleep during their ICU stay; and 29% to 48% have no recall of specific ICU events. Copyright © 2011 Elsevier Inc. All rights reserved.

  4. The Fangshan/Family-based Ischemic Stroke Study In China (FISSIC protocol

    Directory of Open Access Journals (Sweden)

    Chen Dafang

    2007-09-01

    Full Text Available Abstract Background The exact etiology of ischemic stroke remains unclear, because multiple genetic predispositions and environmental risk factors may be involved, and their interactions dictate the complexity. Family-based studies provide unique features in design, while they are currently underrepresented for studies of ischemic stroke in developing countries. The Fangshan/Family-based Ischemic Stroke Study In China (FISSIC program aims to conduct a genetic pedigree study of ischemic stroke in rural communities of China. Methods/Design The pedigrees of ischemic stroke with clear documentation are recruited by using the proband-initiated contact method, based on the stroke registry in hospital and communities. Blood samples and detailed information of pedigrees are collected through the health care network in the rural area, and prospective follow-up of the pedigrees cohort is scheduled. Complementary strategies of both family-based design and matched case-spousal control design are used, and comprehensive statistical methods will be implemented to ascertain potential complex genetic and environmental factors and their interactions as well. Discussion This study is complementary to other genetic pedigree studies of ischemic stroke, such as the Siblings With Ischemic Stroke Study (SWISS, which are established in developed countries. We describe the protocol of this family-based genetic epidemiological study that may be used as a new practical guideline and research paradigm in developing countries and facilitate initiatives of stroke study for international collaborations.

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

    International Nuclear Information System (INIS)

    Park, Won Se; Lee, Hae Na; Jeong, Jin Sun; Kwon, Jung Hoon; Lee, Grace H; Kim, Kee Dong

    2012-01-01

    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.

  6. 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.

  7. Simulation modelling as a tool for knowledge mobilisation in health policy settings: a case study protocol.

    Science.gov (United States)

    Freebairn, L; Atkinson, J; Kelly, P; McDonnell, G; Rychetnik, L

    2016-09-21

    Evidence-informed decision-making is essential to ensure that health programs and services are effective and offer value for money; however, barriers to the use of evidence persist. Emerging systems science approaches and advances in technology are providing new methods and tools to facilitate evidence-based decision-making. Simulation modelling offers a unique tool for synthesising and leveraging existing evidence, data and expert local knowledge to examine, in a robust, low risk and low cost way, the likely impact of alternative policy and service provision scenarios. This case study will evaluate participatory simulation modelling to inform the prevention and management of gestational diabetes mellitus (GDM). The risks associated with GDM are well recognised; however, debate remains regarding diagnostic thresholds and whether screening and treatment to reduce maternal glucose levels reduce the associated risks. A diagnosis of GDM may provide a leverage point for multidisciplinary lifestyle modification interventions. This research will apply and evaluate a simulation modelling approach to understand the complex interrelation of factors that drive GDM rates, test options for screening and interventions, and optimise the use of evidence to inform policy and program decision-making. The study design will use mixed methods to achieve the objectives. Policy, clinical practice and research experts will work collaboratively to develop, test and validate a simulation model of GDM in the Australian Capital Territory (ACT). The model will be applied to support evidence-informed policy dialogues with diverse stakeholders for the management of GDM in the ACT. Qualitative methods will be used to evaluate simulation modelling as an evidence synthesis tool to support evidence-based decision-making. Interviews and analysis of workshop recordings will focus on the participants' engagement in the modelling process; perceived value of the participatory process, perceived

  8. Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

    Science.gov (United States)

    Reveiz, Ludovic; Haby, Michelle M; Martínez-Vega, Ruth; Pinzón-Flores, Carlos E; Elias, Vanessa; Smith, Emma; Pinart, Mariona; Broutet, Nathalie; Becerra-Posada, Francisco; Aldighieri, Sylvain; Van Kerkhove, Maria D

    2017-01-01

    Given the severity and impact of the current Zika virus (ZIKV) outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV. We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols. Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome). Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design. Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to minimize bias at

  9. Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

    Directory of Open Access Journals (Sweden)

    Ludovic Reveiz

    Full Text Available Given the severity and impact of the current Zika virus (ZIKV outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV.We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols.Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome. Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design.Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to

  10. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  11. Comparative study of 2 oral care protocols in intensive care units.

    Science.gov (United States)

    Ory, Jérôme; Raybaud, Evelyne; Chabanne, Russell; Cosserant, Bernard; Faure, Jean Sébastien; Guérin, Renaud; Calvet, Laure; Pereira, Bruno; Mourgues, Charline; Guelon, Dominique; Traore, Ousmane

    2017-03-01

    The quality of oral care is important in limiting the emergence of ventilator-associated pneumonia (VAP) in intubated patients. Our main objective was to measure the quality improvement in oral care following the implementation of a new oral care protocol. We also monitored VAP rates. This was a cohort study of patients in 5 adult ICUs covering different specialties. During period 1, caregivers used a foam stick for oral care and during period 2 a stick and tooth brushing with aspiration. Oral chlorhexidine was used during both periods. The caregivers rated improvement in oral health on the basis of 4 criteria (tongue, mucous membranes, gingivae, and teeth). Caregiver satisfaction was also assessed. The incidence of VAP was monitored. A total of 2,030 intubated patients admitted to intensive care units benefited from oral care. The patient populations during the 2 periods were similar with regard to demographic data and VAP potential risk factors. Oral health was significantly better from the third day of oral care in period 2 onward (period 1, 6.4 ± 2.1; period 2, 5.6 ± 1.8; P = .043). Caregivers found the period 2 protocol easier to implement and more effective. VAP rates decreased significantly between the 2 periods (period 1, 12.8%; period 2, 8.5%; P = .002). Our study showed that the implementation of a simple strategy improved the quality of oral care of patients in intensive care units, and decreased VAP rates. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  12. Concrete release protocol case studies for decommissioning work at the Idaho National Engineering and Environmental Laboratory

    International Nuclear Information System (INIS)

    Kamboj, S.; Arnish, J.; Chen, S-Y; Parker, F. L.; Phillips, A. M.; Tripp, J. L.; Meservey, R. H.

    2000-01-01

    The US Department of Energy (DOE) Order 5400.5, ''Radiation Protection of the Public and Environment'' contains provisions pertinent to releasing potentially radioactive materials from DOE facilities for reuse or recycle. A process of authorized release for materials recovered from radiation areas is permitted under Order 5400.5 and the proposed rule in Title 10, Part 834, of the Code of Federal Regulations (10 CFR Part 834). A generic disposition protocol to facilitate release of concrete under these provisions has been developed. This report analyzes the application of that generic protocol to site-specific cases at the Idaho National Engineering and Environmental Laboratory (INEEL). The potential radiological doses and costs for several concrete disposition alternatives for the sewage treatment plant (STP) at the Central Facilities Area (CFA) of INEEL were evaluated in this analysis. Five disposition alternatives were analyzed for the concrete: (A) decontaminate, crush, and reuse; (B) crush and reuse without decontamination; (C) decontaminate, demolish, and dispose of at a nonradiological landfill; (D) demolish and dispose of at a nonradiological landfill without decontamination; and (E) demolish and dispose of at a low-level radioactive waste (LLW) facility. The analysis was performed for disposition of concrete from four INEEL structures: (1) trickle filter, (2) primary clarifier, (3) secondary clarifier, and (4) CFA-691 pumphouse for a generic case (based on default parameters from the disposition protocol) and an INEEL-specific case (based on INEEL-specific parameters). The results of the analysis indicated that Alternatives B and D would incur the lowest cost and result in a dose less than 1 mrem/yr (except for the trickle filter, the dose for which was estimated at 1.9 mrem/yr) for nonradiological workers. The analysis indicated that the main contributor to the radiological dose would be cobalt-60 contamination in the concrete. A characterization conducted

  13. Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Hunger, Christina; Hilzinger, Rebecca; Koch, Theresa; Mander, Johannes; Sander, Anja; Bents, Hinrich; Schweitzer, Jochen

    2016-03-31

    Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT. This article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes. The study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of

  14. Mapping research activity on mental health disorders in Europe: study protocol for the Mapping_NCD project.

    Science.gov (United States)

    Berg Brigham, Karen; Darlington, Meryl; Wright, John S F; Lewison, Grant; Kanavos, Panos; Durand-Zaleski, Isabelle

    2016-05-26

    Mental health disorders (MHDs) constitute a large and growing disease burden in Europe, although they typically receive less attention and research funding than other non-communicable diseases (NCDs). This study protocol describes a methodology for the mapping of MHD research in Europe as part of Mapping_NCD, a 2-year project funded by the European Commission which seeks to map European research funding and impact for five NCDs in order to identify potential gaps, overlaps, synergies and opportunities, and to develop evidence-based policies for future research. The project aims to develop a multi-focal view of the MHD research landscape across the 28 European Union Member States, plus Iceland, Norway and Switzerland, through a survey of European funding entities, analysis of research initiatives undertaken in the public, voluntary/not-for-profit and commercial sectors, and expert interviews to contextualize the gathered data. The impact of MHD research will be explored using bibliometric analyses of scientific publications, clinical guidelines and newspaper stories reporting on research initiatives. Finally, these research inputs and outputs will be considered in light of various metrics that have been proposed to inform priorities for the allocation of research funds, including burden of disease, treatment gaps and cost of illness. Given the growing burden of MHDs, a clear and broad view of the current state of MHD research is needed to ensure that limited resources are directed to evidence-based priority areas. MHDs pose a particular challenge in mapping the research landscape due to their complex nature, high co-morbidity and varying diagnostic criteria. Undertaking such an effort across 31 countries is further challenged by differences in data collection, healthcare systems, reimbursement rates and clinical practices, as well as cultural and socioeconomic diversity. Using multiple methods to explore the spectrum of MHD research funding activity across Europe

  15. A Prospective Pilot Study to Validate the Management Protocol for Patients Presenting with Acute Urinary Retention: A Community-Based, Nonhospitalised Protocol

    Directory of Open Access Journals (Sweden)

    Shyamala S. Gopi

    2006-01-01

    Full Text Available Acute urinary retention (AUR in males is managed conventionally by hospital admission, alpha-adrenergic therapy, and trial without catheter. To reduce inpatient bed pressures, we set up a protocol to manage such patients in the community. We review our results in this paper. We performed a prospective study of male patients presenting to our acute admissions ward and Accident and Emergency department over 6 months. Patients with chronic urinary retention, macroscopic haematuria, sepsis, urinary tract infection, and/or serum creatinine >130 mmol/l were excluded from the study. Those enrolled were catheterised, commenced on alfuzosin (10 mg nocte, and discharged to the community. A trial without catheter (TWOC was performed 5—7 days later. QoL/IPSS, peak flow rate, and residual volume assessment were performed following successful TWOC 3 months later.Thirty-one male patients with a median age of 69 years were studied and the median residual volume following catheterisation was 900 ml. The aetiology of AUR was benign prostatic hyperplasia (BPH in 29 patients and constipation in the remaining 2 patients. TWOC was successful in 19 patients (61.3% following first TWOC, 26 (83.9% following second trial of voiding. The mean peak flow rate was 6.5 ml/sec and postvoid scan 165 ml, following an immediate TWOC. At 3 months follow-up, mean peak flow rate was 13.2 ml/sec, postvoid scan 26.5 ml, IPSS 4.5, and QoL score was 2. This study has shown that AUR can be managed safely and effectively in the community. Effective communication with the nurse urology specialist, general practitioner, and emergency department are crucial for the successful implementation of the protocol.

  16. 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

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

    Science.gov (United States)

    van Norden, Anouk Gw; de Laat, Karlijn F; Gons, Rob Ar; van Uden, Inge Wm; van Dijk, Ewoud J; van Oudheusden, Lucas Jb; Esselink, Rianne Aj; Bloem, Bastiaan R; van Engelen, Baziel Gm; Zwarts, Machiel J; Tendolkar, Indira; Olde-Rikkert, Marcel G; van der Vlugt, Maureen J; Zwiers, Marcel P; Norris, David G; de Leeuw, Frank-Erik

    2011-02-28

    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. 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. 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 matter in the transition from "normal" aging to cognitive and

  18. A multi-institutional study of the perceived barriers and facilitators to implementing evidence-based practice.

    Science.gov (United States)

    Duncombe, Daphne C

    2018-03-01

    To examine perceived barriers and facilitators to implementing evidence-based practice among nurses working in psychiatric, geriatric, hospital and community settings in The Bahamas. It is evident from previous studies that a number of factors exist which either obstruct or promote the utilisation of research evidence in nursing practice. Identifying these factors is vital to the successful uptake of evidence-based practice in nursing. Descriptive, comparative study. Data were collected using self-administered questionnaires. A stratified random sample (n = 100) of registered nurses participated; 5-point Likert-like scales were used to examine nurses' perceptions of barriers and facilitators of evidence-based practice. Descriptive statistics were used to describe demographic characteristics and to compare responses of nurses. Participants were predominantly female (98.4%), in the 25 to implement evidence-based practice previously. The greatest barriers identified were as follows: "Inadequate resources for implementing research findings" (85.2%; n = 52) and "Inadequate training in research methods" (83.6%; n = 51). The top facilitators identified were as follows: "Training in research methods" (88.5%; n = 54) and "Organisational policies and protocols that are evidence-based" (86.9%; n = 53). Nurses generally expressed that they required additional training in research and evidence-based practice concepts. Although some nurses had a desire to implement evidence-based practice to provide quality care and improve patient outcomes, many expressed that they lacked the required resources. The study draws attention to the need for prioritisation of evidence-based practice both at institutional and governmental levels. Successful adoption of evidence-based practice implies combined efforts of nurses, healthcare providers and policymakers. Further research is needed to determine the best method for successfully incorporating evidence-based practice into nursing

  19. Prevalence of obesity in attention-deficit/hyperactivity disorder: study protocol for a systematic review and meta-analysis.

    Science.gov (United States)

    Cortese, Samuele; Moreira Maia, Carlos Renato; Rohde, Luis Augusto; Morcillo-Peñalver, Carmen; Faraone, Stephen V

    2014-03-18

    An increasing number of clinical and epidemiological studies suggest a possible association between attention-deficit/hyperactivity disorder (ADHD) and obesity/overweight. However, overall evidence is mixed. Given the public health relevance of ADHD and obesity/overweight, understanding whether and to what extent they are associated is paramount to plan intervention and prevention strategies. We describe the protocol of a systematic review and meta-analysis aimed at assessing the prevalence of obesity/overweight in individuals with ADHD versus those without ADHD. We will include studies of any design (except case reports or case series) comparing the prevalence of obesity and/or overweight in children or adults with and without ADHD (or hyperkinetic disorder). We will search an extensive number of databases including PubMed, Ovid databases, Web of Knowledge and Thomson-Reuters databases, ERIC and CINAHL. No restrictions of language will be applied. We will also contact experts in the field for possible unpublished or in press data. Primary and additional outcomes will be the prevalence of obesity and overweight, respectively. We will combine ORs using random-effects models in STATA V.12.0. The quality of the study will be assessed primarily using the Newcastle-Ottawa Scale. Subgroup meta-analyses will be conducted according to participants' age (children vs adults) and study setting (clinical vs general population). We will explore the feasibility of conducting meta-regression analyses to assess the moderating effect of age, gender, socioeconomic status, study setting, geographic location of the study (low-income, middle-income countries vs high-income countries), definition of obesity, method to assess ADHD, psychiatric comorbidities and medication status. No ethical issues are foreseen. The results will be published in a peer-reviewed journal and presented at national and international conferences of psychiatry, psychology, obesity and paediatrics. PROSPERO

  20. An analysis of moderate sedation protocols used in dental specialty programs: a retrospective observational study.

    Science.gov (United States)

    Setty, Madhavi; Montagnese, Thomas A; Baur, Dale; Aminoshariae, Anita; Mickel, Andre

    2014-09-01

    Pain and anxiety control is critical in dental practice. Moderate sedation is a useful adjunct in managing a variety of conditions that make it difficult or impossible for some people to undergo certain dental procedures. The purpose of this study was to analyze the sedation protocols used in 3 dental specialty programs at the Case Western Reserve University School of Dental Medicine, Cleveland, OH. A retrospective analysis was performed using dental school records of patients receiving moderate sedation in the graduate endodontic, periodontic, and oral surgery programs from January 1, 2010, to December 31, 2012. Information was gathered and the data compiled regarding the reasons for sedation, age, sex, pertinent medical conditions, American Society of Anesthesiologists physical status classifications, routes of administration, drugs, dosages, failures, complications, and other information that was recorded. The reasons for the use of moderate sedation were anxiety (54%), local anesthesia failures (15%), fear of needles (15%), severe gag reflex (8%), and claustrophobia with the rubber dam (8%). The most common medical conditions were hypertension (17%), asthma (15%), and bipolar disorder (8%). Most patients were classified as American Society of Anesthesiologists class II. More women (63.1%) were treated than men (36.9%). The mean age was 45 years. Monitoring and drugs varied among the programs. The most common tooth treated in the endodontic program was the mandibular molar. There are differences in the moderate sedation protocols used in the endodontic, periodontic, and oral surgery programs regarding monitoring, drugs used, and record keeping. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

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

    International Nuclear Information System (INIS)

    Soares, M. R.; Maia, A. F.; Batista, W. O.; Caldas, L. V. E.; Lara, P. A.

    2014-08-01

    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)

  2. 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)

  3. Using salivary cortisol to measure the effects of a Wilbarger protocol-based procedure on sympathetic arousal: a pilot study.

    Science.gov (United States)

    Kimball, Judith G; Lynch, Keara M; Stewart, Kelli C; Williams, Nicole E; Thomas, Meghan A; Atwood, Kam D

    2007-01-01

    This study investigated changes in salivary cortisol, the stress hormone, after administration of a procedure based on the Wilbarger protocol to children diagnosed with sensory defensiveness (SD), a type of sensory modulation dysfunction. Using a single-subject design across participants, we studied 4 boys with SD ages 3 to 5 years. Each participant completed four sessions consisting of the collection of a saliva sample, administration of a procedure based on the Wilbarger protocol, 15 min of quiet neutral activities to allow time for any changes in cortisol level to manifest in the saliva, and the second collection of saliva. Saliva samples were analyzed using enzyme-linked immunosorbent assay (ELISA). Salivary cortisol levels in all participants changed after each of four applications of a procedure based on the Wilbarger protocol. The cortisol levels of 2 children whose levels were relatively higher on pretest decreased at each posttest. The levels of 1 child whose cortisol was higher on pretest three times decreased those three times and increased the one time the pretest cortisol was lower. The levels of 1 child who had the lowest cortisol levels of any of the children increased each time. Therefore, in all participants, cortisol moved in the direction of modulation. In these 4 boys, a procedure based on the Wilbarger protocol modulated cortisol levels toward a middle range. This pilot study indicates that there is an association between sympathetic nervous system response and the Wilbarger protocol-based procedure, as indicated by salivary cortisol levels.

  4. Improving the care of people with traumatic brain injury through the Neurotrauma Evidence Translation (NET program: protocol for a program of research

    Directory of Open Access Journals (Sweden)

    Green Sally E

    2012-08-01

    Full Text Available Abstract The Neurotrauma Evidence Translation (NET program was funded in 2009 to increase the uptake of research evidence in the clinical care of patients who have sustained traumatic brain injury. This paper reports the rationale and plan for this five-year knowledge translation research program. The overarching aims of the program are threefold: to improve outcomes for people with traumatic brain injury; to create a network of neurotrauma clinicians and researchers with expertise in knowledge translation and evidence-based practice; and to contribute knowledge to the field of knowledge translation research. The program comprises a series of interlinked projects spanning varying clinical environments and disciplines relevant to neurotrauma, anchored within four themes representing core knowledge translation activities: reviewing research evidence; understanding practice; developing and testing interventions for practice change; and building capacity for knowledge translation in neurotrauma. The program uses a range of different methods and study designs, including: an evidence fellowship program; conduct of and training in systematic reviews; mixed method study designs to describe and understand factors that influence current practices (e.g., semi-structured interviews and surveys; theory-based methods to develop targeted interventions aiming to change practice; a cluster randomised trial to test the effectiveness of a targeted theory-informed intervention; stakeholder involvement activities; and knowledge translation events such as consensus conferences.

  5. Bioremediation protocols

    National Research Council Canada - National Science Library

    Sheehan, David

    1997-01-01

    ..., .. . . . . .. ,. . . .. . . . . . . . .. . . . . .. . . .. . .. 3 2 Granular Nina Sludge Christiansen, Consortia lndra for Bioremediation, M. Mathrani, and Birgitte K. Ahring . 23 PART II PROTOCOLS...

  6. The effectiveness of Korean medicine treatment in male patients with infertility: a study protocol for a prospective observational pilot study.

    Science.gov (United States)

    Kim, Kwan-Ii; Jo, Junyoung

    2018-01-01

    Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality.This will be a single-center, prospective, case-only observational pilot study. About 20 male patients with infertility who visit Conmaul Hospital of Korean Medicine will be recruited. We will follow the standard treatment protocol, which has shown good results in the treatment of male infertility. The protocol is composed mainly of a 10-week herbal decoction treatment; acupuncture and/or pharmacopuncture are added when needed. Semen samples, quality of life, and the scrotal temperatures of infertile men will be observed before and after the 10-week treatment with KM.The study has received ethical approval from the Public Institutional Review Board (approval number: P01-201708-21-008). The findings will be disseminated to appropriate audiences via peer-reviewed publication and conference presentations. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002611.

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

    Science.gov (United States)

    Costa, Fábio Wildson Gurgel; Brito, Gerly Anne de Castro; Pessoa, Rosana Maria Andrade; Studart-Soares, Eduardo Costa

    2011-01-01

    The aim of this study was to evaluate the effects of liquid nitrogen cryosurgery on the femoral diaphysis of rats. 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. 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. 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.

  8. Mobile Phone Cognitive Bias Modification Research Platform for Substance Use Disorders: Protocol for a Feasibility Study.

    Science.gov (United States)

    Zhang, Melvyn; Ying, JiangBo; Song, Guo; Fung, Daniel Ss; Smith, Helen

    2018-06-12

    Cognitive biases refer to automatic attentional and interpretational tendencies, which could be retained by cognitive bias modification interventions. Cristea et al and Jones et al have published reviews (in 2016 and 2017 respectively) on the effectiveness of such interventions. The advancement of technologies such as electronic health (eHealth) and mobile health (mHealth) has led to them being harnessed for the delivery of cognitive bias modification. To date, at least eight studies have demonstrated the feasibility of mobile technologies for the delivery of cognitive bias modification. Most of the studies are limited to a description of the conventional cognitive bias modification methodology that has been adopted. None of the studies shared the developmental process for the methodology involved, such that future studies could adopt it in the cost-effective replication of such interventions. It is important to have a common platform that could facilitate the design and customization of cognitive bias modification interventions for a variety of psychiatric and addictive disorders. It is the aim of the current research protocol to describe the design of a research platform that allows for customization of cognitive bias modification interventions for addictive disorders. A multidisciplinary team of 2 addiction psychiatrists, a psychologist with expertise in cognitive bias modification, and a computer engineer, were involved in the development of the intervention. The proposed platform would comprise of a mobile phone version of the cognitive bias task which is controlled by a server that could customize the algorithm for the tasks and collate the reaction-time data in realtime. The server would also allow the researcher to program the specific set of images that will be present in the task. The mobile phone app would synchronize with the backend server in real-time. An open-sourced cross-platform gaming software from React Native was used in the current development

  9. Establishment and optimization of NMR-based cell metabonomics study protocols for neonatal Sprague-Dawley rat cardiomyocytes.

    Science.gov (United States)

    Zhang, Ming; Sun, Bo; Zhang, Qi; Gao, Rong; Liu, Qiao; Dong, Fangting; Fang, Haiqin; Peng, Shuangqing; Li, Famei; Yan, Xianzhong

    2017-01-15

    A quenching, harvesting, and extraction protocol was optimized for cardiomyocytes NMR metabonomics analysis in this study. Trypsin treatment and direct scraping cells in acetonitrile were compared for sample harvesting. The results showed trypsin treatment cause normalized concentration increasing of phosphocholine and metabolites leakage, since the trypsin-induced membrane broken and long term harvesting procedures. Then the intracellular metabolite extraction efficiency of methanol and acetonitrile were compared. As a result, washing twice with phosphate buffer, direct scraping cells and extracting with acetonitrile were chosen to prepare cardiomyocytes extracts samples for metabonomics studies. This optimized protocol is rapid, effective, and exhibits greater metabolite retention. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Ramadan fasting: Evidence or expert opinion? Results of preliminary studies

    Directory of Open Access Journals (Sweden)

    1Maryam Kazemi

    2013-11-01

    Full Text Available Each year, over a billion Muslims fast worldwide during the month of Ramadan. Through this religious practice, not only will one have spiritual growth, but can improve his/her diet, which is of pivotal importance in this month. Conversely, the available evidence regarding the health benefits of Ramadan fasting is scarce and highly contentious. Although Islam exempts patients from fasting, many of them fast conceivably and their clinical condition is prone to deteriorate. This is due to the persistent gap between current expert knowledge and conclusive, strong evidence regarding the pathophysiologic and metabolic alterations by fasting, and the consensus that healthcare professionals should reach, in order to manage various patient groups during this month. In this review, we summarize the results of our initial studies regarding the effects of Ramadan fasting on some clinical conditions including alterations of body composition. We also go through the important clinical results of patients who have had previous history of cardiovascular disease, type 2 diabetes, asthma and renal colic. Our studies have presented some evidence in favor of Ramadan fasting and encourage those with mentioned diseases to consult their physicians and follow medical and scientific recommendations. We attempt to present some relevant evidence clarify future scopes in this area of study, and provide suggestions for future investigations.

  11. Ramadan fasting: Evidence or expert opinion? Results of preliminary studies

    Directory of Open Access Journals (Sweden)

    Maryam Kazemi

    2013-12-01

    Full Text Available Each year, over a billion Muslims fast worldwide during the month of Ramadan.  Through this religious practice, not only will one have spiritual growth, but can improve his/her diet, which is of pivotal importance in this month. Conversely, the available evidence regarding the health benefits of Ramadan fasting is scarce and highly contentious. Although Islam exempts patients from fasting, many of them fast conceivably and their clinical condition is prone to deteriorate. This is due to the persistent gap between current expert knowledge and conclusive, strong evidence regarding the pathophysiologic and metabolic alterations by fasting, and the consensus that healthcare professionals should reach, in order to manage various patient groups during this month. In this review, we summarize the results of our initial studies regarding the effects of Ramadan fasting on some clinical conditions including alterations of body composition. We also go through the important clinical results of patients who have had previous history of cardiovascular disease, type 2 diabetes, asthma and renal colic. Our studies have presented some evidence in favor of Ramadan fasting and encourage those with mentioned diseases to consult their physicians and follow medical and scientific recommendations. We attempt to present some relevant evidence clarify future scopes in this area of study, and provide suggestions for future investigations.

  12. 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

  13. A radiographic comparative study of two series of skeletally mature clubfeet treated by two different protocols

    Energy Technology Data Exchange (ETDEWEB)

    Ippolito, E.; Caterini, R.; Farsetti, P. [Department of Orthopaedic Surgery, University of Rome ' ' Tor Vergata' ' , Via della Ricerca Scientifica 135, 00173, Rome (Italy); Fraracci, L.; Di Mario, M. [Department of Radiology, IRCCS Santa Lucia Institute, Via Ardeatina 306, 00179, Rome (Italy)

    2003-08-01

    To compare the radiographic features of two series of congenital clubfeet to determine whether a different treatment protocol may influence the radiographic results at the end of skeletal growth. Two series of patients with congenital clubfeet, treated by two different manipulative techniques and by two different complementary soft tissue release operations, were radiographically studied at skeletal maturity. Twenty-one normal feet of the unilateral cases in both series served as controls. Anteroposterior and lateral radiographs of the feet were taken with the patient standing, and several radiographic parameters were studied. The size of the talus and calcaneus and the height of the talar trochlea were smaller than normal in all cases of clubfeet, were similar in both series and were not influenced by treatment, whereas all the other radiographic parameters studied were more or less different between the two series and seemed to be influenced by treatment. In no treated clubfoot of either series was a normal radiographic foot anatomy restored, not even in those feet that had an excellent clinical result. (orig.)

  14. A radiographic comparative study of two series of skeletally mature clubfeet treated by two different protocols

    International Nuclear Information System (INIS)

    Ippolito, E.; Caterini, R.; Farsetti, P.; Fraracci, L.; Di Mario, M.

    2003-01-01

    To compare the radiographic features of two series of congenital clubfeet to determine whether a different treatment protocol may influence the radiographic results at the end of skeletal growth. Two series of patients with congenital clubfeet, treated by two different manipulative techniques and by two different complementary soft tissue release operations, were radiographically studied at skeletal maturity. Twenty-one normal feet of the unilateral cases in both series served as controls. Anteroposterior and lateral radiographs of the feet were taken with the patient standing, and several radiographic parameters were studied. The size of the talus and calcaneus and the height of the talar trochlea were smaller than normal in all cases of clubfeet, were similar in both series and were not influenced by treatment, whereas all the other radiographic parameters studied were more or less different between the two series and seemed to be influenced by treatment. In no treated clubfoot of either series was a normal radiographic foot anatomy restored, not even in those feet that had an excellent clinical result. (orig.)

  15. Health risk behaviours amongst school adolescents: protocol for a mixed methods study

    Directory of Open Access Journals (Sweden)

    Youness El Achhab

    2016-11-01

    Full Text Available Abstract Background Determining risky behaviours of adolescents provides valuable information for designing appropriate intervention programmes for advancing adolescent’s health. However, these behaviours are not fully addressed by researchers in a comprehensive approach. We report the protocol of a mixed methods study designed to investigate the health risk behaviours of Moroccan adolescents with the goal of identifying suitable strategies to address their health concerns. Methods We used a sequential two-phase explanatory mixed method study design. The approach begins with the collection of quantitative data, followed by the collection of qualitative data to explain and enrich the quantitative findings. In the first phase, the global school-based student health survey (GSHS was administered to 800 students who were between 14 and 19 years of age. The second phase engaged adolescents, parents and teachers in focus groups and assessed education documents to explore the level of coverage of health education in the programme learnt in the middle school. To obtain opinions about strategies to reduce Moroccan adolescents’ health risk behaviours, a nominal group technique will be used. Discussion The findings of this mixed methods sequential explanatory study provide insights into the risk behaviours that need to be considered if intervention programmes and preventive strategies are to be designed to promote adolescent’s health in the Moroccan school.

  16. Design, Implementation, and Study Protocol of a Kindergarten-Based Health Promotion Intervention

    Directory of Open Access Journals (Sweden)

    Susanne Kobel

    2017-01-01

    Full Text Available Inactivity and an unhealthy diet amongst others have led to an increased prevalence of overweight and obesity even in young children. Since most health behaviours develop during childhood health promotion has to start early. The setting kindergarten has been shown as ideal for such interventions. “Join the Healthy Boat” is a kindergarten-based health promotion programme with a cluster-randomised study focussing on increased physical activity, reduced screen media use, and sugar-sweetened beverages, as well as a higher fruit and vegetable intake. Intervention and materials were developed using Bartholomew’s Intervention Mapping approach considering Bandura’s social-cognitive theory and Bronfenbrenner’s ecological framework for human development. The programme is distributed using a train-the-trainer approach and currently implemented in 618 kindergartens. The effectiveness of this one-year intervention with an intervention and a control group will be examined in 62 kindergartens using standardised protocols, materials, and tools for outcome and process evaluation. A sample of 1021 children and their parents provided consent and participated in the intervention. Results of this study are awaited to give a better understanding of health behaviours in early childhood and to identify strategies for effective health promotion. The current paper describes development and design of the intervention and its implementation and planned evaluation. Trial Registration. The study is registered at the German Clinical Trials Register (DRKS, Freiburg University, Germany, ID: DRKS00010089.

  17. Study of accent-based music speech protocol development for improving voice problems in stroke patients with mixed dysarthria.

    Science.gov (United States)

    Kim, Soo Ji; Jo, Uiri

    2013-01-01

    Based on the anatomical and functional commonality between singing and speech, various types of musical elements have been employed in music therapy research for speech rehabilitation. This study was to develop an accent-based music speech protocol to address voice problems of stroke patients with mixed dysarthria. Subjects were 6 stroke patients with mixed dysarthria and they received individual music therapy sessions. Each session was conducted for 30 minutes and 12 sessions including pre- and post-test were administered for each patient. For examining the protocol efficacy, the measures of maximum phonation time (MPT), fundamental frequency (F0), average intensity (dB), jitter, shimmer, noise to harmonics ratio (NHR), and diadochokinesis (DDK) were compared between pre and post-test and analyzed with a paired sample t-test. The results showed that the measures of MPT, F0, dB, and sequential motion rates (SMR) were significantly increased after administering the protocol. Also, there were statistically significant differences in the measures of shimmer, and alternating motion rates (AMR) of the syllable /K$\\inve$/ between pre- and post-test. The results indicated that the accent-based music speech protocol may improve speech motor coordination including respiration, phonation, articulation, resonance, and prosody of patients with dysarthria. This suggests the possibility of utilizing the music speech protocol to maximize immediate treatment effects in the course of a long-term treatment for patients with dysarthria.

  18. The ASTUTE Health study protocol: deliberative stakeholder engagements to inform implementation approaches to healthcare disinvestment.

    Science.gov (United States)

    Watt, Amber M; Hiller, Janet E; Braunack-Mayer, Annette J; Moss, John R; Buchan, Heather; Wale, Janet; Riitano, Dagmara E; Hodgetts, Katherine; Street, Jackie M; Elshaug, Adam G

    2012-10-22

    Governments and other payers are yet to determine optimal processes by which to review the safety, effectiveness, and cost-effectiveness of technologies and procedures that are in active use within health systems, and rescind funding (partially or fully) from those that display poor profiles against these parameters. To further progress a disinvestment agenda, a model is required to support payers in implementing disinvestment in a transparent manner that may withstand challenge from vested interests and concerned citizens. Combining approaches from health technology assessment and deliberative democratic theory, this project seeks to determine if and how wide stakeholder engagement can contribute to improved decision-making processes, wherein the views of both vested and non-vested stakeholders are seen to contribute to informing policy implementation within a disinvestment context. Systematic reviews pertaining to illustrative case studies were developed and formed the evidence base for discussion. Review findings were presented at a series of deliberative, evidence-informed stakeholder engagements, including partisan (clinicians and consumers) and non-partisan (representative community members) stakeholders. Participants were actively facilitated towards identifying shared and dissenting perspectives regarding public funding policy for each of the case studies and developing their own funding models in response to the evidence presented. Policy advisors will subsequently be invited to evaluate disinvestment options based on the scientific and colloquial evidence presented to them, and to explore the value of this information to their decision-making processes with reference to disinvestment. Analysis of the varied outputs of the deliberative engagements will contribute to the methodological development around how to best integrate scientific and colloquial evidence for consideration by policy advisors. It may contribute to the legitimization of broad and

  19. [An integrative and transdiagnostic relaxation protocol for anxious patients. Results of a pilot study].

    Science.gov (United States)

    Servant, D; Germe, A; Autuori, M; De Almeida, F; Hay, M; Douilliez, C; Vaiva, G

    2014-12-01

    The literature data show that relaxation practice is effective in reducing anxiety symptoms. Different techniques such as progressive muscular relaxation, autogenic training, applied relaxation and meditation have been evaluated independently for anxiety disorders. The question is to know whether the combination of various techniques may be of interest in the transdiagnostic treatment of anxiety disorders. The present study assessed the short-term efficacy of a 10-week integrative and transdiagnostic relaxation program for anxiety disorders in outpatients of an anxiety disorders unit. The diagnoses were made according to the Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) and completed with an assessment of anxiety and depressive symptoms using: the State Trait Anxiety Inventory (STAI-Y, -S and -T), the Penn State Worry Questionnaire (PSWQ) and the Beck Depression Inventory (BDI-II). Four techniques were integrated into the structured 10-week protocol: breathing control, muscular relaxation, meditation and mental visualization. Twenty-eight patients (12 men and 16 women), mean age (S.D.)=38.82 years (11.57), were included in the study. All the included patients fulfilled the DSM-IV criteria for a current diagnosis of Generalized Anxiety Disorder (n=13) or Panic Disorder (n=15) with or without agoraphobia. At the end of the 10 sessions, we found a significant reduction in mean scores (S.D.) on the STAI-T from 53.179 (6.037) to 49.821 (8.028) (P<0.02), the BDI-II 20.964 (13.167) to 15.429 (11.341) (d=0.6543) and the QIPS 55.071 (10.677) to 49.679 (11.7) (d=0.5938). The observed reduction in the STAI-S (d=0.2776) was not significant. The results of this open study showed that this program significantly decreases the level of trait anxiety, depression and worry. The integrative and transdiagnostic relaxation program could represent an accessible and effective treatment to reduce anxious and depressive symptoms in various anxiety disorders

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

    Directory of Open Access Journals (Sweden)

    Samuel Sepúlveda

    2015-09-01

    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.

  1. 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.

  2. 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

    Recent developments in Multi-party Computation (MPC) has resulted in very efficient protocols for dishonest majority in the preprocessing model. In particular, two very promising protocols for Boolean circuits have been proposed by Nielsen et al. (nicknamed TinyOT) and by Damg˚ard and Zakarias...... 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...... of a large number of AES encryptions and find that it performs better than results reported so far on TinyOT, on the same hardware.p...

  3. Evidence-based care of older people with suspected cognitive impairment in general practice: protocol for the IRIS cluster randomised trial.

    Science.gov (United States)

    McKenzie, Joanne E; French, Simon D; O'Connor, Denise A; Mortimer, Duncan S; Browning, Colette J; Russell, Grant M; Grimshaw, Jeremy M; Eccles, Martin P; Francis, Jill J; Michie, Susan; Murphy, Kerry; Kossenas, Fiona; Green, Sally E

    2013-08-19

    Dementia is a common and complex condition. Evidence-based guidelines for the management of people with dementia in general practice exist; however, detection, diagnosis and disclosure of dementia have been identified as potential evidence-practice gaps. Interventions to implement guidelines into practice have had varying success. The use of theory in designing implementation interventions has been limited, but is advocated because of its potential to yield more effective interventions and aid understanding of factors modifying the magnitude of intervention effects across trials. This protocol describes methods of a randomised trial that tests a theory-informed implementation intervention that, if effective, may provide benefits for patients with dementia and their carers. This trial aims to estimate the effectiveness of a theory-informed intervention to increase GPs' (in Victoria, Australia) adherence to a clinical guideline for the detection, diagnosis, and management of dementia in general practice, compared with providing GPs with a printed copy of the guideline. Primary objectives include testing if the intervention is effective in increasing the percentage of patients with suspected cognitive impairment who receive care consistent with two key guideline recommendations: receipt of a i) formal cognitive assessment, and ii) depression assessment using a validated scale (primary outcomes for the trial). The design is a parallel cluster randomised trial, with clusters being general practices. We aim to recruit 60 practices per group. Practices will be randomised to the intervention and control groups using restricted randomisation. Patients meeting the inclusion criteria, and GPs' detection and diagnosis behaviours directed toward these patients, will be identified and measured via an electronic search of the medical records nine months after the start of the intervention. Practitioners in the control group will receive a printed copy of the guideline. In

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

    DEFF Research Database (Denmark)

    Dragoni, Nicola; Gaspari, Mauro

    2012-01-01

    Auction mechanisms are nowadays widely used in electronic commerce Web sites for buying and selling items among different users. The increasing importance of auction protocols in the negotiation phase is not limited to online marketplaces. In fact, the wide applicability of auctions as resource‐a...... about the specification of an English Auction protocol which tolerate crashes of bidding agents and we discuss its properties....

  5. Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Asher, Laura; De Silva, Mary; Hanlon, Charlotte; Weiss, Helen A; Birhane, Rahel; Ejigu, Dawit A; Medhin, Girmay; Patel, Vikram; Fekadu, Abebaw

    2016-06-24

    Care for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper describes the protocol of a study that aims to evaluate the effectiveness of community-based rehabilitation as an adjunct to health facility-based care in rural Ethiopia. This is a cluster randomised trial set in a rural district in Ethiopia, with sub-district as the unit of randomisation. Participants will be recruited from an existing cohort of people with schizophrenia receiving treatment in primary care. Fifty-four sub-districts will be randomly allocated in a 1:1 ratio to facility-based care plus community-based rehabilitation (intervention arm) or facility-based care alone (control arm). Facility-based care consists of treatment by a nurse or health officer in primary care (antipsychotic medication, basic psychoeducation and follow-up) with referral to a psychiatric nurse-led outpatient clinic or psychiatric hospital when required. Trained community-based rehabilitation workers will deliver a manualised community-based rehabilitation intervention, with regular individual and group supervision. We aim to recruit 182 people with schizophrenia and their caregivers. Potential participants will be screened for eligibility, including enduring or disabling illness. Participants will be recruited after providing informed consent or, for participants without decision-making capacity, after the primary caregiver gives permission on behalf of the participant. The primary outcome is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS) version 2.0 at 12 months. The sample

  6. Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

    Science.gov (United States)

    Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

    2018-01-01

    The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and

  7. Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Van Dorn, Richard A; Desmarais, Sarah L; Rade, Candalyn B; Burris, Elizabeth N; Cuddeback, Gary S; Johnson, Kiersten L; Tueller, Stephen J; Comfort, Megan L; Mueser, Kim T

    2017-08-04

    Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population. This paper describes a study that will develop research and communication protocols and adapt two evidence-based treatments, dual-diagnosis motivational interviewing (DDMI) and integrated group therapy (IGT), for delivery to adults with CODs across a jail-to-community treatment continuum. Adaptations to DDMI and IGT were guided by the Risk-Need-Responsivity model and the National Institute of Corrections' implementation competencies; the development of the implementation framework and communication protocols were guided by the Evidence-Based Interagency Implementation Model for community corrections and the Inter-organizational Relationship model, respectively. Implementation and evaluation of the protocols and adapted interventions will occur via an open trial and a pilot randomized trial. The clinical intervention consists of two in-jail DDMI sessions and 12 in-community IGT sessions. Twelve adults with CODs and four clinicians will participate in the open trial to evaluate the acceptability and feasibility of, and fidelity to, the interventions and research and communication protocols. The pilot controlled trial will be conducted with 60 inmates who will be randomized to either DDMI-IGT or treatment as usual. A baseline assessment will be conducted in jail, and four community-based assessments will be conducted during a 6-month follow-up period. Implementation, clinical, public health, and treatment preference outcomes will be evaluated

  8. A protocol for isolating insect mitochondrial genomes: a case study of NUMT in Melipona flavolineata (Hymenoptera: Apidae).

    Science.gov (United States)

    Françoso, Elaine; Gomes, Fernando; Arias, Maria Cristina

    2016-07-01

    Nuclear mitochondrial DNA insertions (NUMTs) are mitochondrial DNA sequences that have been transferred into the nucleus and are recognized by the presence of indels and stop codons. Although NUMTs have been identified in a diverse range of species, their discovery was frequently accidental. Here, our initial goal was to develop and standardize a simple method for isolating NUMTs from the nuclear genome of a single bee. Subsequently, we tested our new protocol by determining whether the indels and stop codons of the cytochrome c oxidase subunit I (COI) sequence of Melipona flavolineata are of nuclear origin. The new protocol successfully demonstrated the presence of a COI NUMT. In addition to NUMT investigations, the protocol described here will also be very useful for studying mitochondrial mutations related to diseases and for sequencing complete mitochondrial genomes with high read coverage by Next-Generation technology.

  9. Multisite Semiautomated Clinical Data Repository for Duplication 15q Syndrome: Study Protocol and Early Uses.

    Science.gov (United States)

    Ajayi, Oluwaseun Jessica; Smith, Ebony Jeannae; Viangteeravat, Teeradache; Huang, Eunice Y; Nagisetty, Naga Satya V Rao; Urraca, Nora; Lusk, Laina; Finucane, Brenda; Arkilo, Dimitrios; Young, Jennifer; Jeste, Shafali; Thibert, Ronald; Reiter, Lawrence T

    2017-10-18

    Chromosome 15q11.2-q13.1 duplication syndrome (Dup15q syndrome) is a rare disorder caused by duplications of chromosome 15q11.2-q13.1, resulting in a wide range of developmental disabilities in affected individuals. The Dup15q Alliance is an organization that provides family support and promotes research to improve the quality of life of patients living with Dup15q syndrome. Because of the low prevalence of this condition, the establishment of a single research repository would have been difficult and more time consuming without collaboration across multiple institutions. The goal of this project is to establish a national deidentified database with clinical and survey information on individuals diagnosed with Dup15q syndrome. The development of a multiclinic site repository for clinical and survey data on individuals with Dup15q syndrome was initiated and supported by the Dup15q Alliance. Using collaborative workflows, communication protocols, and stakeholder engagement tools, a comprehensive database of patient-centered information was built. We successfully established a self-report populating, centralized repository for Dup15q syndrome research. This repository also resulted in the development of standardized instruments that can be used for other studies relating to developmental disorders. By standardizing the data collection instruments, it allows us integrate our data with other national databases, such as the National Database for Autism Research. A substantial portion of the data collected from the questionnaires was facilitated through direct engagement of participants and their families. This allowed for a more complete set of information to be collected with a minimal turnaround time. We developed a repository that can efficiently be mined for shared clinical phenotypes observed at multiple clinic sites and used as a springboard for future clinical and basic research studies. ©Oluwaseun Jessica Ajayi, Ebony Jeannae Smith, Teeradache Viangteeravat

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

    International Nuclear Information System (INIS)

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

    2012-01-01

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

  11. Study protocol for an approach based on diagnosis and therapy of cutaneous radiation induced lesions

    International Nuclear Information System (INIS)

    Di Giorgio, Marina; Vallerga, Maria B.; Radl, Analia; Portas, Mercedes

    2008-01-01

    Full text: In the frame of an agreement between the 'Hospital de Quemados del Gobierno de la Ciudad de Buenos Aires'-Burn Center- (a reference hospital of the Medical Radiological Emergency Response Network of Argentina) and the Nuclear Regulatory Authority, a research project for diagnostic and therapeutic approach of cutaneous radiation syndrome (CRS) is in progress. Sixty seven persons, which developed acute and/or late CRS, were included in this protocol from 1997 to 2007, treated with an equivalent therapeutic scheme and evaluated through clinical follow-up, serial photographic record and complementary tests (tele-thermography and high frequency ultrasonography). There exist individual variations that could condition the response to ionizing radiation (IR) in not only accidental but also planned exposures (such as radiotherapy and interventional radiology). Deficiencies in DNA repair mechanisms would be involved on hypersensitivity to deterministic effects of IR. Consequently, the characterization of DNA repair capacity in lymphocytes through cytokinesis blocked micronucleus (MN) and alkaline single-cell microgel electrophoresis (comet) assays could be suitable approaches to evaluate in vitro individual radiosensitivity. Under this context, individual radiosensitivity assessment was conducted in patients included in this research protocol that showed acute and/or late cutaneous reactions with grades 3 and 4 of the Toxicity Criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer. DNA repair capacity was evaluated through MN and comet assay for initial damage and after specific times of repair (0-120 minutes). DNA damage and repair capacity were quantified by the Olive tail moment. Previous own studies have identified three subpopulations, characterized by the mean values of their repair mean half-time: healthy controls (2.6 ± 0.3 minutes), average-reactor cancer patients (4.7 ± 2.9 minutes) and over

  12. Study Protocol for an Approach Based on Diagnosis and Therapy of Cutaneous Radiation Induced Lesions

    International Nuclear Information System (INIS)

    Di Giorgio, M.; Vallerga, M.B.; Radl, A.; Portas, M.

    2011-01-01

    In the frame of an agreement between the 'Hospital de Quemados del Gobierno de la Ciudad de Buenos Aires' - Burn Center - (a reference hospital of the Medical Radiological Emergency Response Network of Argentina) and the Nuclear Regulatory Authority, a research project for diagnostic and therapeutic approach of cutaneous radiation syndrome (CRS) is in progress. Sixty seven persons, which developed acute and/or late CRS, were included in this protocol from 1997 to 2007, treated with an equivalent therapeutic scheme and evaluated through clinical follow-up, serial photographic record and complementary tests (telethermography and high frequency ultrasonography). There exist individual variations that could condition the response to ionizing radiation (IR) in not only accidental but also planned exposures (such as radiotherapy and interventional radiology). Deficiencies in DNA repair mechanisms would be involved on hypersensitivity to deterministic effects of IR. Consequently, the characterization of DNA repair capacity in lymphocytes through cytokinesis blocked micronucleus (MN) and alkaline single-cell microgel electrophoresis (comet) assays could be suitable approaches to evaluate in vitro individual radiosensitivity. Under this context, individual radiosensitivity assessment was conducted in patients included in this research protocol that showed acute and/or late cutaneous reactions with grades 3 and 4 of the Toxicity Criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer. DNA repair capacity was evaluated through MN and comet assay for initial damage and after specific times of repair (0-120 minutes). DNA damage and repair capacity were quantified by the Olive tail moment. Previous own studies have identified three subpopulations, characterized by the mean values of their repair mean half-time: healthy controls (2.6 ± 0.3 minutes), average-reactor cancer patients (4.7 ± 2.9 minutes) and over

  13. Methodological Study to Develop Standard Operational Protocol on Oral Drug Administration for Children.

    Science.gov (United States)

    Bijarania, Sunil Kumar; Saini, Sushma Kumari; Verma, Sanjay; Kaur, Sukhwinder

    2017-05-01

    To develop standard operational protocol (SOP) on oral drug administration and checklist to assess the implementation of the developed SOP. In this prospective methodological study, SOPs were developed in five phases. In the first phase, the preliminary draft of SOPs and checklists were prepared based on literature review, assessment of current practices and focus group discussion (FGD) with bedside working nurses. In the second phase, content validity was checked with the help of Delphi technique (12 experts). Total four drafts were prepared in stages and necessary modifications were made as per suggestions after each Delphi round. Fourth Delphi round was performed after conducting a pilot study. In the fourth phase, all bedside nurses were trained as per SOPs and asked to practice accordingly and observation of thirty oral drug administrations in children was done to check reliability of checklists for implementation of SOPs. In Phase-V, 7 FGDs were conducted with bedside nurses to assess the effectiveness of SOPs. The Content Validity Index (CVI) of SOP and checklists was 99.77%. Overall standardized Cronbach's alpha was calculated as 0.94. All the nurses felt that the SOP is useful. Valid and feasible SOP for drug administration to children through oral route along with valid and reliable checklist were developed. It is recommended to use this document for drug administration to children.

  14. 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.

  15. Comparison of the ultrashort gonadotropin-releasing hormone agonist-antagonist protocol with microdose flare -up protocol in poor responders: a preliminary study.

    Science.gov (United States)

    Berker, Bülent; Duvan, Candan İltemir; Kaya, Cemil; Aytaç, Ruşen; Satıroğlu, Hakan

    2010-01-01

    To determine the potential effect of the ultrashort gonadotropin-releasing hormone (GnRH) agonist/GnRH antagonist protocol versus the microdose GnRH agonist protocol in poor responders undergoing intracytoplasmic sperm injection (ICSI). The patients in the Agonist-Antagonist Group (n=41) were administered the ultrashort GnRH-agonist/ antagonist protocol, while the patients in the Microdose Group (n=41) were stimulated according to the microdose flare-up protocol. The mean number of mature oocytes retrieved was the primary outcome measure. Fertilization rate, implantation rate per embryo and clinical pregnancy rates were secondary outcome measures. There was no differenc between the mean number of mature oocytes retrieved in the two groups. There were also no statistical differences between the two groups in terms of peak serum E2 level, canceled cycles, endometrial thickness on hCG day, number of 2 pronucleus and number of embryos transferred. However, the total gonadotropin consumption and duration of stimulation were significantly higher with the Agonist-Antagonist Group compared with the Microdose Group. The implantation and clinical pregnancy rates were similar between the two groups. Despite the high dose of gonadotropin consumption and longer duration of stimulation with the ultrashort GnRH agonist/ antagonist protocol, it seems that the Agonist-Antagonist Protocol is not inferior to the microdose protocol in poor responders undergoing ICSI.

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

    Directory of Open Access Journals (Sweden)

    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.

  17. 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

  18. 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

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

    Science.gov (United States)

    Ribeiro, Manuel C; Pereira, Maria J; Soares, Amílcar; Branquinho, Cristina; Augusto, Sofia; Llop, Esteve; Fonseca, Susana; Nave, Joaquim G; Tavares, António B; Dias, Carlos M; Silva, Ana; Selemane, Ismael; de Toro, Joaquin; Santos, Mário J; Santos, Fernanda

    2010-10-15

    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. 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. 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. We believe that variability of simulated exposure values at

  20. The NEIL Memory Research Unit: psychosocial, biological, physiological and lifestyle factors associated with healthy ageing: study protocol.

    Science.gov (United States)

    Hannigan, Caoimhe; Coen, Robert F; Lawlor, Brian A; Robertson, Ian H; Brennan, Sabina

    2015-01-01

    Population ageing is a global phenomenon that has characterised demographic trends during the 20th and 21st century. The rapid growth in the proportion of older adults in the population, and resultant increase in the incidence of age-related cognitive decline, dementia and Alzheimer's disease, brings significant social, economic and healthcare challenges. Decline in cognitive abilities represents the most profound threat to active and healthy ageing. Current evidence suggests that a significant proportion of cases of age-related cognitive decline and dementia may be preventable through the modification of risk factors including education, depressive symptomology, physical activity, social engagement and participation in cognitively stimulating activities. The NEIL Memory Research Unit cohort study was established to investigate factors related to brain health and the maintenance of cognitive function. A cohort of 1000 normally ageing adults aged 50 years and over are being recruited to participate in comprehensive assessments at baseline, and at follow-up once every 2 years. The assessment protocol comprises a comprehensive neuropsychological battery, some basic physical measures, psychosocial scales, questionnaire measures related to a range of health, lifestyle and behavioural factors, and a measure of resting state activity using electroencephalography (EEG). The NEIL Memory Research Unit cohort study will address key questions about brain health and cognitive ageing in the population aged 50+, with a particular emphasis on the influence of potentially modifiable factors on cognitive outcomes. Analyses will be conducted with a focus on factors involved in the maintenance of cognitive function among older adults, and therefore will have the potential to contribute significant knowledge related to key questions within the field of cognitive ageing, and to inform the development of public health interventions aimed at preventing cognitive decline and promoting

  1. Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST).

    Science.gov (United States)

    Stott, David J; Gussekloo, Jacobijn; Kearney, Patricia M; Rodondi, Nicolas; Westendorp, Rudi G J; Mooijaart, Simon; Kean, Sharon; Quinn, Terence J; Sattar, Naveed; Hendry, Kirsty; Du Puy, Robert; Den Elzen, Wendy P J; Poortvliet, Rosalinde K E; Smit, Jan W A; Jukema, J Wouter; Dekkers, Olaf M; Blum, Manuel; Collet, Tinh-Hai; McCarthy, Vera; Hurley, Caroline; Byrne, Stephen; Browne, John; Watt, Torquil; Bauer, Douglas; Ford, Ian

    2017-02-03

    Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH. Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture. This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition. Clinicaltrials.gov NCT01660126 ; registered 8th June 2012.

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

    Directory of Open Access Journals (Sweden)

    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

  3. MyVoice National Text Message Survey of Youth Aged 14 to 24 Years: Study Protocol.

    Science.gov (United States)

    DeJonckheere, Melissa; Nichols, Lauren P; Moniz, Michelle H; Sonneville, Kendrin R; Vydiswaran, V G Vinod; Zhao, Xinyan; Guetterman, Timothy C; Chang, Tammy

    2017-12-11

    There has been little progress in adolescent health outcomes in recent decades. Researchers and youth-serving organizations struggle to accurately elicit youth voice and translate youth perspectives into health care policy. Our aim is to describe the protocol of the MyVoice Project, a longitudinal mixed methods study designed to engage youth, particularly those not typically included in research. Text messaging surveys are collected, analyzed, and disseminated in real time to leverage youth perspectives to impact policy. Youth aged 14 to 24 years are recruited to receive weekly text message surveys on a variety of policy and health topics. The research team, including academic researchers, methodologists, and youth, develop questions through an iterative writing and piloting process. Question topics are elicited from community organizations, researchers, and policy makers to inform salient policies. A youth-centered interactive platform has been developed that automatically sends confidential weekly surveys and incentives to participants. Parental consent is not required because the survey is of minimal risk to participants. Recruitment occurs online (eg, Facebook, Instagram, university health research website) and in person at community events. Weekly surveys collect both quantitative and qualitative data. Quantitative data are analyzed using descriptive statistics. Qualitative data are quickly analyzed using natural language processing and traditional qualitative methods. Mixed methods integration and analysis supports a more in-depth understanding of the research questions. We are currently recruiting and enrolling participants through in-person and online strategies. Question development, weekly data collection, data analysis, and dissemination are in progress. MyVoice quickly ascertains the thoughts and opinions of youth in real time using a widespread, readily available technology-text messaging. Results are disseminated to researchers, policy makers, and

  4. Regional gastrointestinal transit and pH studied in 215 healthy volunteers using the wireless motility capsule: influence of age, gender, study country and testing protocol.

    Science.gov (United States)

    Wang, Y T; Mohammed, S D; Farmer, A D; Wang, D; Zarate, N; Hobson, A R; Hellström, P M; Semler, J R; Kuo, B; Rao, S S; Hasler, W L; Camilleri, M; Scott, S M

    2015-09-01

    The wireless motility capsule (WMC) offers the ability to investigate luminal gastrointestinal (GI) physiology in a minimally invasive manner. To investigate the effect of testing protocol, gender, age and study country on regional GI transit times and associated pH values using the WMC. Regional GI transit times and pH values were determined in 215 healthy volunteers from USA and Sweden studied using the WMC over a 6.5-year period. The effects of test protocol, gender, age and study country were examined. For GI transit times, testing protocol was associated with differences in gastric emptying time (GET; shorter with protocol 2 (motility capsule ingested immediately after meal) vs. protocol 1 (motility capsule immediately before): median difference: 52 min, P = 0.0063) and colonic transit time (CTT; longer with protocol 2: median 140 min, P = 0.0189), but had no overall effect on whole gut transit time. Females had longer GET (by median 17 min, P = 0.0307), and also longer CTT by (104 min, P = 0.0285) and whole gut transit time by (263 min, P = 0.0077). Increasing age was associated with shorter small bowel transit time (P = 0.002), and study country also influenced small bowel and CTTs. Whole gut and CTTs showed clustering of data at values separated by 24 h, suggesting that describing these measures as continuous variables is invalid. Testing protocol, gender and study country also significantly influenced pH values. Regional GI transit times and pH values, delineated using the wireless motility capsule (WMC), vary based on testing protocol, gender, age and country. Standardisation of testing is crucial for cross-referencing in clinical practice and future research. © 2015 John Wiley & Sons Ltd.

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

    NARCIS (Netherlands)

    M. Gallastegi (Mara); M. Guxens Junyent (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

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

    Science.gov (United States)

    Cleak, Helen; Schofield, Margot; Bickerdike, Andrew

    2014-01-21

    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 type of family violence, and determine the impact of violence profiles on FDR processes and outcomes, such as the type and durability of shared parenting arrangements and clients' satisfaction with mediated agreements. A mixed method, naturalistic longitudinal design is used. The sampling frame is clients presenting at nine family mediation centres across metropolitan, outer suburban, and regional/rural sites in Victoria, Australia. Data are collected at pre-test, completion of mediation, and six months later. Self-administered surveys are administered at the three time points, and a telephone interview at the final post-test. The key study variable is family violence. Key outcome measures are changes in the type and level of acrimony and violent behaviours, the relationship between violence and mediated agreements, the durability of agreements over six months, and client satisfaction with mediation. Family violence is a major risk to the physical and mental health of women and children. This study will inform debates about the role of family violence and how to manage it in the family mediation context. It will also inform decision-making about mediation practices by better understanding how mediation impacts on parenting agreements, and the implications for children, especially in the context of family violence.

  7. A trial of a job-specific workers' health surveillance program for construction workers: study protocol.

    Science.gov (United States)

    Boschman, Julitta S; van der Molen, Henk F; van Duivenbooden, Cor; Sluiter, Judith K; Frings-Dresen, Monique H W

    2011-09-29

    Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS) to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS) group (n = 206) with that of a control (WHS) group (n = 206). The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the preventive actions undertaken by them within the scope of a job

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

    Science.gov (United States)

    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 type of family violence, and determine the impact of violence profiles on FDR processes and outcomes, such as the type and durability of shared parenting arrangements and clients’ satisfaction with mediated agreements. Methods A mixed method, naturalistic longitudinal design is used. The sampling frame is clients presenting at nine family mediation centres across metropolitan, outer suburban, and regional/rural sites in Victoria, Australia. Data are collected at pre-test, completion of mediation, and six months later. Self-administered surveys are administered at the three time points, and a telephone interview at the final post-test. The key study variable is family violence. Key outcome measures are changes in the type and level of acrimony and violent behaviours, the relationship between violence and mediated agreements, the durability of agreements over six months, and client satisfaction with mediation. Discussion Family violence is a major risk to the physical and mental health of women and children. This study will inform debates about the role of family violence and how to manage it in the family mediation context. It will also inform decision-making about mediation practices by better understanding how mediation impacts on parenting agreements, and the implications for children, especially in the context of family violence. PMID:24443936

  9. Learning from positively deviant wards to improve patient safety: an observational study protocol.

    Science.gov (United States)

    Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Lawton, Rebecca

    2015-12-11

    Positive deviance is an asset-based approach to improvement which has recently been adopted to improve quality and safety within healthcare. The approach assumes that solutions to problems already exist within communities. Certain groups or individuals identify these solutions and succeed despite having the same resources as others. Within healthcare, positive deviance has previously been applied at individual or organisational levels to improve specific clinical outcomes or processes of care. This study explores whether the positive deviance approach can be applied to multidisciplinary ward teams to address the broad issue of patient safety among elderly patients. Preliminary work analysed National Health Service (NHS) Safety Thermometer data from 34 elderly medical wards to identify 5 'positively deviant' and 5 matched 'comparison' wards. Researchers are blinded to ward status. This protocol describes a multimethod, observational study which will (1) assess the concurrent validity of identifying positively deviant elderly medical wards using NHS Safety Thermometer data and (2) generate hypotheses about how positively deviant wards succeed. Patient and staff perceptions of safety will be assessed on each ward using validated surveys. Correlation and ranking analyses will explore whether this survey data aligns with the routinely collected NHS Safety Thermometer data. Staff focus groups and researcher fieldwork diaries will be completed and qualitative thematic content analysis will be used to generate hypotheses about the strategies, behaviours, team cultures and dynamics that facilitate the delivery of safe patient care. The acceptability and sustainability of strategies identified will also be explored. The South East Scotland Research Ethics Committee 01 approved this study (reference: 14/SS/1085) and NHS Permissions were granted from all trusts. Findings will be published in peer-reviewed, scientific journals, and presented at academic conferences. This study

  10. A trial of a job-specific workers' health surveillance program for construction workers: study protocol

    Directory of Open Access Journals (Sweden)

    Sluiter Judith K

    2011-09-01

    Full Text Available Abstract Background Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. Methods/Design The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS group (n = 206 with that of a control (WHS group (n = 206. The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. Discussion This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the

  11. Using environmental engineering to increase hand hygiene compliance: a cross-over study protocol.

    Science.gov (United States)

    Schmidtke, Kelly Ann; Aujla, Navneet; Marshall, Tom; Hussain, Abid; Hodgkinson, Gerard P; Arheart, Kristopher; Marti, Joachim; Birnbach, David J; Vlaev, Ivo

    2017-09-11

    Compliance with hand hygiene recommendations in hospital is typically less than 50%. Such low compliance inevitably contributes to hospital-acquired infections that negatively affect patients' well-being and hospitals' finances. The design of the present study is predicated on the assumption that most people who fail to clean their hands are not doing so intentionally, they just forget. The present study will test whether psychological priming can be used to increase the number of people who clean their hands on entering a ward. Here, we present the protocol for this study. The study will use a randomised cross-over design. During the study, each of four wards will be observed during four conditions: olfactory prime, visual prime, both primes and neither prime. Each condition will be experienced for 42 days followed by a 7-day washout period (total duration of trial=189 days). We will record the number of people who enter each ward and whether they clean their hands during observation sessions, the amount of cleaning material used from the dispensers each week and the number of hospital-acquired infections that occur in each period. The outcomes will be compared using a regression analysis. Following the initial trail, the most effective priming condition will be rolled out for 3 months in all the wards. Research ethics approval was obtained from the South Central-Oxford C Research Ethics Committee (16/SC/0554), the Health Regulatory Authority and the sponsor. ISRCTN (15397624); Edge ID 86357. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. 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

  13. 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...

  14. PARENTS 2 study protocol: pilot of Parents' Active Role and ENgagement in the review of Their Stillbirth/perinatal death.

    Science.gov (United States)

    Bakhbakhi, Danya; Siassakos, Dimitrios; Storey, Claire; Heazell, Alexander; Lynch, Mary; Timlin, Laura; Burden, Christy

    2018-01-10

    The perinatal mortality review meeting that takes place within the hospital following a stillbirth or neonatal death enables clinicians to learn vital lessons to improve care for women and their families for the future. Recent evidence suggests that parents are unaware that a formal review following the death of their baby takes place. Many would welcome the opportunity to feedback into the meeting itself. Parental involvement in the perinatal mortality review meeting has the potential to improve patient satisfaction, drive improvements in patient safety and promote an open culture within healthcare. Yet evidence on the feasibility of involving bereaved parents in the review process is lacking. This paper describes the protocol for the Parents' Active Role and Engangement iN the review of their Stillbirth/perinatal death study (PARENTS 2) , whereby healthcare professionals' and stakeholders' perceptions of parental involvement will be investigated, and parental involvement in the perinatal mortality review will be piloted and evaluated at two hospitals. We will investigate perceptions of parental involvement in the perinatal mortality review process by conducting four focus groups. A three-round modified Delphi technique will be employed to gain a consensus on principles of parental involvement in the perinatal mortality review process. We will use three sequential rounds, including a national consensus meeting workshop with experts in stillbirth, neonatal death and bereavement care, and a two-stage anonymous online questionnaire. We will pilot a new perinatal mortality review process with parental involvement over a 6-month study period. The impact of the new process will be evaluated by assessing parents' experiences of their care and parents' and staff perceptions of their involvement in the process by conducting further focus groups and using a Parent Generated Index questionnaire. This study has ethical approval from the UK Health Research Authority. We will

  15. A study on postsplenectomy changes of serum tuftsin level using a radioimmunoassay protocol

    International Nuclear Information System (INIS)

    Gao Ping; Li Zhen Jia; Chu Hai-Bo; Huang Fen-Rei

    1996-01-01

    In this article, postplenectomy changes of serum tufstin level were studied on both human subjects and rabbits by using a self-established radioimmunoassay protocol. Anituftsin antibodies were raised in rabbits and roosters. 125 I-tufstin was prepared through an Iodogen method. The characterristics of the RIA were satisfactory with a detecting range of 0.5-100 ug/ml and the lowest detection limit of 400ng/ml. Serum tufstin levels of splenectomized subjects were measured and compared with control groups. The serum tufstin level from 30 postsplenectomy human beings was 406 ± 179 ng/ml (x ± s) while that from a control group of 40 healtly blood donors was 557 ± 256 ng/ml; the serum tufstin level of 10 postsplenectomy rabbits was found to be 206 ± 75 ng/ml while that of a control group of 10 normal rabbits was 318 ± 96 ng/ml. The results showed that serum tufstin level decreased markedly after splenectomy. (author). 5 refs., 1 fig., 2 tabs

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

    International Nuclear Information System (INIS)

    Wu, Qier

    2014-01-01

    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)

  17. Study of a scanning HIFU therapy protocol, Part II: Experiment and results

    Science.gov (United States)

    Andrew, Marilee A.; Kaczkowski, Peter; Cunitz, Bryan W.; Brayman, Andrew A.; Kargl, Steven G.

    2003-04-01

    Instrumentation and protocols for creating scanned HIFU lesions in freshly excised bovine liver were developed in order to study the in vitro HIFU dose response and validate models. Computer-control of the HIFU transducer and 3-axis positioning system provided precise spatial placement of the thermal lesions. Scan speeds were selected in the range of 1 to 8 mm/s, and the applied electrical power was varied from 20 to 60 W. These parameters were chosen to hold the thermal dose constant. A total of six valid scans of 15 mm length were created in each sample; a 3.5 MHz single-element, spherically focused transducer was used. Treated samples were frozen, then sliced in 1.27 mm increments. Digital photographs of slices were downloaded to computer for image processing and analysis. Lesion characteristics, including the depth within the tissue, axial length, and radial width, were computed. Results were compared with those generated from modified KZK and BHTE models, and include a comparison of the statistical variation in the across-scan lesion radial width. [Work supported by USAMRMC.

  18. Defining antimicrobial stewardship competencies for undergraduate health professional education in the United Kingdom: A study protocol.

    Science.gov (United States)

    Courtenay, Molly; Castro-Sánchez, Enrique; Deslandes, Rhian; Hodson, Karen; Lim, Rosemary; Morris, Gary; Reeves, Scott; Weiss, Marjorie

    2018-04-16

    Multi-drug resistant infections have been identified as one of the greatest threats to human health. Healthcare professionals are involved in an array of patient care activities for which an understanding of antimicrobial stewardship is important. Although antimicrobial prescribing and stewardship competencies have been developed for healthcare professionals who adopt the role of a prescriber, competencies do not exist for other medicine-related stewardship activities. Undergraduate education provides an ideal opportunity to prepare healthcare professionals for these roles and activities. This report presents a protocol for a study designed to provide national consensus on antimicrobial stewardship competencies appropriate for undergraduate healthcare professional education. A modified Delphi process will be used in which a panel of Experts, comprising members from across the United Kingdom, with expertise in prescribing and medicines management with regard to the education and practice of healthcare professionals, and antimicrobial prescribing and stewardship, will be invited to take part in two survey rounds. The competencies developed will be applicable to all undergraduate healthcare professional education programmes. They will help to standardise curricula content and enhance the impact of antimicrobial stewardship education.

  19. Qualitative approach to patient-reported outcomes in oncology: protocol of a French study.

    Science.gov (United States)

    Orri, Massimiliano; Sibeoni, Jordan; Labey, Mathilde; Bousquet, Guilhem; Verneuil, Laurence; Revah-Levy, Anne

    2015-07-10

    The past decade has been characterised by movement from a doctor-centred to a patient-centred approach to treatment outcomes, in which doctors try to see the illness through their patients' eyes. Patients, family members and doctors are the three participants in cancer care, but their perspectives about what have been helpful during cancer treatment have never simultaneously and explicitly compared in the same qualitative study. The aim of this study project is to explore patients' perspectives about the care they receive, as well as families' and doctors' perspectives about what have been helpful for the patient. These three points of view will be compared and contrasted in order to analyse the convergences and divergences in these perspectives. This is a national multicentre qualitative study. Participants will be constituted by three different subsamples: (1) patients with cancer (skin, breast, urological and lung cancers), (2) their relatives, and (3) their referring physicians. Recruitment will follow the purposive sample technique, and the final sample size will be determined by data saturation. Data will be collected through open-ended semistructured interviews and independently analysed with NVivo V.10 software by three researchers according to the principles of Interpretative Phenomenological Analysis. The research protocol received approval from the University Paris Descartes review board (IRB number: 20140600001072), and participants will provide written consent. To the best of our knowledge, this is the first study to focus on the simultaneous exploration of the separate points of view of patients, families and doctors about the care received during the cancer care journey. We expect that our findings will help to improve communication and relationships between doctors, patients and families. Comparison of these three points of view will provide information about the convergences and divergences of these perspectives and how to address the needs of all

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

    Directory of Open Access Journals (Sweden)

    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.

  1. Factors predisposing nursing home resident to inappropriate transfer to emergency department. The FINE study protocol

    Directory of Open Access Journals (Sweden)

    Amélie Perrin

    2017-09-01

    Full Text Available Background: Each year, around one out of two nursing home (NH residents are hospitalized in France, and about half to the emergency department (ED. These transfers are frequently inappropriate. This paper describes the protocol of the FINE study. The first aim of this study is to identify the factors associated with inappropriate transfers to ED. Methods/design: FINE is a case-control observational study. Sixteen hospitals participate. Inclusion period lasts 7 days per season in each center for a total period of inclusion of one year. All the NH residents admitted in ED during these periods are included. Data are collected in 4 times: before transfer in the NH, at the ED, in hospital wards in case of patient's hospitalization and at the patient's return to NH. The appropriateness of ED transfers (i.e. case versus control NH residents is determined by a multidisciplinary team of experts. Results: Our primary objective is to determine the factors predisposing NH residents to inappropriate transfer to ED. Our secondary objectives are to assess the cost of the transfers to ED; study the evolution of NH residents' functional status and the psychotropic and inappropriate drugs prescription between before and after the transfer; calculate the prevalence of potentially avoidable transfers to ED; and identify the factors predisposing NH residents to potentially avoidable transfer to ED. Discussion: A better understanding of the determinant factors of inappropriate transfers to ED of NH residents may lead to proposals of recommendations of better practice in NH and would allow implementing quality improvement programs in the health organization. Keywords: Inappropriate transfer, Nursing home resident, Emergency department transfer, Potentially avoidable transfer, Appropriateness of transfer, Inappropriate hospitalization

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

    Directory of Open Access Journals (Sweden)

    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

  3. DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol.

    Science.gov (United States)

    Tobe, Sheldon W; Wentworth, Joan; Ironstand, Laurie; Hartman, Susan; Hoppe, Jackie; Whiting, Judi; Kennedy, Janice; McAllister, Colin; Kiss, Alex; Perkins, Nancy; Vincent, Lloyd; Pylypchuk, George; Lewanczuk, Richard Z

    2009-05-09

    The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management. The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed. The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel) study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management. Protocol NCT00325624.

  4. Describing the first 2000 registrations to the Research Registry®: A study protocol

    Directory of Open Access Journals (Sweden)

    Alexander J. Fowler

    Full Text Available Background: In 2013, the Declaration of Helsinki was updated and required the registration of all research studies involving human participants. Prior registries focussed on the registration of clinical trials and systematic reviews, and we estimate that only 10% of observational research is registered in a publically accessible registry. The Research Registry® was established to provide a venue of registration for any study, prospectively or retrospectively, involving human participants. This protocol describes the analysis for the first 2000 registrations received to the Research Registry®. Methods and analysis: Data for each registration to the Research Registry® (www.researchregistry.com, adapted from the World Health Organisation minimum data set, has been collected since the launch of the registry in 2015. A weekly curation process ensures that inappropriate registrations, such as duplicate studies or those not involving human participants, are removed from the registry. We will present the characteristics of the first 2000 registrations and how they have changed overtime. A quality score will be calculated for each registration by two independent teams, and inter-rater reliability will be calculated. Funding sources of work registered will also be presented. This process will also be performed for the systematic review portion of the registry (‘The Review Registry’, which will be considered separately. Ethics and dissemination: Ethical approval is not required for this study as it involves no human participants. The findings will be presented at international conferences and published in a peer reviewed journal.

  5. Study of groundwater collection protocols on the IPEN/CNEN-SP campus

    International Nuclear Information System (INIS)

    Marques, Joyce R.; Villa, Sabrina M.; Monteiro, Lucilena R.; Cotrim, Marycel E.B.; Pires, Maria Aparecida F.

    2013-01-01

    As per Brazilian Health Ministry's evaluation, industry is the second activity that most contaminates the soil in Sao Paulo Metropolitan region. In order to assess this scenario and keep a continuous logging of IPEN's installations effect over chemical compounds levels, and to improve the installation radioactive logging, in the region under its campus influence, since 2006, IPEN performs the groundwater monitoring, in the region where it is located. Collections are performed bimonthly in seven monitoring wells, evaluating 17 parameters. These values are compared to the ones established by CONAMA 396/08 Resolution, which provides the groundwater classification and environmental guidelines to chemically stable compounds. So far IPEN keeps the wells in good conditions and performs sampling methods studies to adequate it to current legal standards. The groundwater collection method and the wells characterization, concerning the anionic species content (F - , Cl - , Br - , NO 2 - , NO 3 - , PO 4 -3 e SO 4 -2 ), are evaluated in the present study. The purge procedure requirement was also evaluated. The well purging is the procedure for withdrawing water from inside the well, so the collection is performed only after the water level restoration, thereby ensuring that the water collected represents the aquifer. The use of 'bailer', which requires purging, and a called 'low flow pump', which requires no purging for sample collection, was also evaluated. These methods were selected in this study because they are recommended by CETESB 6410/88, the local standard to groundwater sample collection. Thus some anions concentrations in groundwater sampled with different purging procedures and collection were compared. The concentration change in each well performed with the same collection procedure was compared with the other collection methods variation in order to evaluate if these are equivalents. From the results obtained in this comparative study was possible to optimize the

  6. DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol

    Directory of Open Access Journals (Sweden)

    Kiss Alex

    2009-05-01

    Full Text Available Abstract Background The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management. Methods and design The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed. Discussion The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management. Trial Registration Protocol NCT00325624

  7. Barriers and facilitators to physical activity in people with hip or knee osteoarthritis: protocol for a systematic review of qualitative evidence.

    Science.gov (United States)

    Kanavaki, Archontissa M; Rushton, Alison; Klocke, Rainer; Abhishek, Abhishek; Duda, Joan L

    2016-11-03

    This protocol aims to describe the objective and methods to be followed in a systematic review of qualitative studies on barriers and facilitators to physical activity (PA) in people with hip or knee osteoarthritis (OA). MEDLINE, EMBASE, PhychINFO, Web of Science, CINAHL, SPORTDiscus, Scopus and grey literature sources will be electronically searched. Hand search of qualitative research-centred journals, reference screening of relevant reviews and inquiries to researchers active in the field will complement the search. Studies will be selected if they apply qualitative or mixed-methods designs to directly explore factors that correspond to engagement in PA/exercise or, the perceptions regarding PA/exercise in people with hip or knee OA. The Critical Appraisal Skills Programme Qualitative Checklist and the evaluative criteria of credibility, transferability, dependability and confirmability will be applied for the study appraisal. 2 independent reviewers will perform the search, study selection and study appraisal. Thematic synthesis will be used for synthesising the findings of the primary studies and the process and product of the synthesis will be checked by a second researcher. ConQual approach will be used for assessing the confidence in the qualitative findings. This systematic review will inform our understanding of the PA determinants and how to optimise behaviour change in people living with hip or knee OA. The review findings will be reported in a peer-reviewed journal and presented at national or international conferences. The study raises no ethical issues. CRD42016030024. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. Benchmarking pediatric cranial CT protocols using a dose tracking software system: a multicenter study

    Energy Technology Data Exchange (ETDEWEB)

    Bondt, Timo de; Parizel, Paul M. [Antwerp University Hospital and University of Antwerp, Department of Radiology, Antwerp (Belgium); Mulkens, Tom [H. Hart Hospital, Department of Radiology, Lier (Belgium); Zanca, Federica [GE Healthcare, DoseWatch, Buc (France); KU Leuven, Imaging and Pathology Department, Leuven (Belgium); Pyfferoen, Lotte; Casselman, Jan W. [AZ St. Jan Brugge-Oostende AV Hospital, Department of Radiology, Brugge (Belgium)

    2017-02-15

    To benchmark regional standard practice for paediatric cranial CT-procedures in terms of radiation dose and acquisition parameters. Paediatric cranial CT-data were retrospectively collected during a 1-year period, in 3 different hospitals of the same country. A dose tracking system was used to automatically gather information. Dose (CTDI and DLP), scan length, amount of retakes and demographic data were stratified by age and clinical indication; appropriate use of child-specific protocols was assessed. In total, 296 paediatric cranial CT-procedures were collected. Although the median dose of each hospital was below national and international diagnostic reference level (DRL) for all age categories, statistically significant (p-value < 0.001) dose differences among hospitals were observed. The hospital with lowest dose levels showed smallest dose