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Sample records for health study protocol

  1. Health Auctions: a Valuation Experiment (HAVE) study protocol

    PubMed Central

    Kularatna, Sanjeewa; Petrie, Dennis; Scuffham, Paul A; Byrnes, Joshua

    2016-01-01

    Introduction Quality-adjusted life years are derived using health state utility weights which adjust for the relative value of living in each health state compared with living in perfect health. Various techniques are used to estimate health state utility weights including time-trade-off and standard gamble. These methods have exhibited limitations in terms of complexity, validity and reliability. A new composite approach using experimental auctions to value health states is introduced in this protocol. Methods and analysis A pilot study will test the feasibility and validity of using experimental auctions to value health states in monetary terms. A convenient sample (n=150) from a population of university staff and students will be invited to participate in 30 auction sets with a group of 5 people in each set. The 9 health states auctioned in each auction set will come from the commonly used EQ-5D-3L instrument. At most participants purchase 2 health states, and the participant who acquires the 2 ‘best’ health states on average will keep the amount of money they do not spend in acquiring those health states. The value (highest bid and average bid) of each of the 24 health states will be compared across auctions to test for reliability across auction groups and across auctioneers. A test retest will be conducted for 10% of the sample to assess reliability of responses for health states auctions. Feasibility of conducting experimental auctions to value health states will also be examined. The validity of estimated health states values will be compared with published utility estimates from other methods. This pilot study will explore the feasibility, reliability and validity in using experimental auction for valuing health states. Ethics and dissemination Ethical clearance was obtained from Griffith University ethics committee. The results will be disseminated in peer-reviewed journals and major international conferences. PMID:27056589

  2. Study Protocol for the Fukushima Health Management Survey

    PubMed Central

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

    2012-01-01

    Background 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. Methods 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. Conclusions 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

  3. Study protocol of the Center for Oral Health Research in Appalachia (COHRA) etiology study

    PubMed Central

    Polk, Deborah E; Weyant, Robert J; Crout, Richard J; McNeil, Daniel W; Tarter, Ralph E; Thomas, John G; Marazita, Mary L

    2008-01-01

    Background People in Appalachia experience some of the worst oral health in the United States. To develop effective intervention and prevention strategies in Appalachia, we must understand the complex relationships among the contributing factors and how they affect the etiology of oral diseases. To date, no such comprehensive analysis has been conducted. This report summarizes the characteristics of the sample and describes the protocol of a study determining contributions of individual, family, and community factors to oral diseases in Appalachian children and their relatives. Methods/Design Families participated in a comprehensive assessment protocol involving interviews, questionnaires, a clinical oral health assessment, a microbiological assessment, and collection of DNA. The design of the study is cross-sectional. Conclusion Due to its multilevel design and large, family-based sample, this study has the potential to greatly advance our understanding of factors that contribute to oral health in Appalachian children. PMID:18522740

  4. Effectiveness of the Health Complex Model in Iranian primary health care reform: the study protocol

    PubMed Central

    Tabrizi, Jafar Sadegh; Farahbakhsh, Mostafa; Sadeghi-Bazargani, Homayoun; Hassanzadeh, Roya; Zakeri, Akram; Abedi, Leili

    2016-01-01

    Background Iranian traditional primary health care (PHC) system, although proven to be successful in some areas in rural populations, suffers major pitfalls in providing PHC services in urban areas especially the slum urban areas. The new government of Iran announced a health reform movement including the health reform in PHC system of Iran. The Health Complex Model (HCM) was chosen as the preferred health reform model for this purpose. Methods This paper aims to report a detailed research protocol for the assessment of the effectiveness of the HCM in Iran. An adaptive controlled design is being used in this research. The study is planned to measure multiple endpoints at the baseline and 2 years after the intervention. The assessments will be done both in a population covered by the HCM, as intervention area, and in control populations covered by the traditional health care system as the control area. Discussion Assessing the effectiveness of the HCM, as the Iranian PHC reform initiative, could help health system policy makers for future decisions on its continuation or modification. PMID:27784996

  5. Iran's Multiple Indicator Demographic and Health Survey - 2010: Study Protocol

    PubMed Central

    Rashidian, Arash; Karimi-Shahanjarini, Akram; Khosravi, Ardeshir; Elahi, Elham; Beheshtian, Maryam; Shakibazadeh, Elham; Khabiri, Roghayeh; Arab, Mohammad; Zakeri, Mohammad-Reza

    2014-01-01

    Background: There is an international emphasis on providing timely and high quality data to monitor progress of countries toward Millennium Development Goals. Iran's Multiple Indicator Demographic and Health Survey (IrMIDHS) aimed to provide valid information on population and health outcomes to monitor progress in achieving national priorities and health programs and to assist policy makers to design effective strategies for improving health outcomes and equity in access to care. Methods: A cross-sectional multi-stage stratified cluster-random survey is conducted through face-to-face household interviews. The sampling frame is developed using Iran's 2006 population and housing census. Provincial samples ranging are from a minimum of 400 households per province to 6400 households in Tehran province. Cluster size is 10 households. The target sample includes 3096 clusters: 2187 clusters in urban and 909 clusters in rural areas. IrMIDHS instruments include three questionnaires: Household questionnaire, women aged 15-54 questionnaire, children under five questionnaire, supervision and quality assessment checklists and data collection sheets and standard weight and height measurement tools for under-five children. A cascading decentralized training method is used for training data collection and supervision teams. Quality assurance procedures are defined for the five steps of conducting the survey including: Sampling, training data collection and training teams, survey implementation, data entry and analysis. A multi-layer supervision and monitoring procedure is established. All the questionnaires are double entered. Conclusions: IrMIDHS will provide valuable data for policymakers in Iran. Designing and implementation of the study involve contributions from academics as well as program managers and policy makers. The collaborative nature of the study may facilitate better usage of its results. PMID:24932396

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

    PubMed Central

    2011-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

    2010-01-01

    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 analysis to appraise

  9. How does capacity building of health managers work? A realist evaluation study protocol

    PubMed Central

    Marchal, Bruno; Hoeree, Tom; Devadasan, Narayanan; Macq, Jean; Kegels, Guy; Criel, Bart

    2012-01-01

    Introduction There has been a lot of attention on the role of human resource management interventions to improve delivery of health services in low- and middle-income countries. However, studies on this subject are few due to limited research on implementation of programmes and methodological difficulties in conducting experimental studies on human resource interventions. The authors present the protocol of an evaluation of a district-level capacity-building intervention to identify the determinants of performance of health workers in managerial positions and to understand how changes (if any) are brought about. Methods and analysis The aim of this study is to understand how capacity building works. The authors will use realist evaluation to evaluate an intervention in Karnataka, India. The intervention is a capacity-building programme that seeks to improve management capacities of health managers at district and subdistrict levels through periodic classroom-based teaching and mentoring support at the workplace. The authors conducted interviews and reviewed literature on capacity building in health to draw out the programme theory of the intervention. Based on this, the authors formulated hypothetical pathways connecting the expected outcomes of the intervention (planning and supervision) to the inputs (contact classes and mentoring). The authors prepared a questionnaire to assess elements of the programme theory—organisational culture, self-efficacy and supervision. The authors shall conduct a survey among health managers as well as collect qualitative data through interviews with participants and non-participants selected purposively based on their planning and supervision performance. The authors will construct explanations in the form of context–mechanism–outcome configurations from the results. This will be iterative and the authors will use a realist evaluation framework to refine the explanatory theories that are based on the findings to explain and

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

    PubMed Central

    2010-01-01

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

  11. Oxfordshire Women and Their Children's Health (OxWATCH): protocol for a prospective cohort feasibility study

    PubMed Central

    Harrison, S; Petrovic, G; Chevassut, A; Brook, L; Higgins, N; Kenworthy, Y; Selwood, M; Snelgar, T; Arnold, L; Boardman, H; Heneghan, C; Leeson, P; Redman, C; Granne, I

    2015-01-01

    Introduction Some specific pregnancy disorders are known to be associated with increased incidence of long-term maternal ill health (eg, gestational diabetes with late onset type 2 diabetes; pre-eclampsia with arterial disease). To what degree these later health conditions are a consequence of the woman's constitution prior to pregnancy rather than pregnancy itself triggering changes in a woman's health is unknown. Additionally, there is little prospective evidence for the impact of pre-pregnancy risk factors on the outcome of pregnancy. To understand the importance of pre-pregnancy health requires the recruitment of women into a long-term cohort study before their first successful pregnancy. The aim of this feasibility study is to test recruitment procedures and acceptability of participation to inform the planning of a future large-scale cohort study. Methods The prospective cohort feasibility study will recruit nulliparous women aged 18–40 years. Women will be asked to complete a questionnaire to assess the acceptability of our recruitment and data collection procedures. Baseline biophysical, genetic, socioeconomic, behavioural and psychological assessments will be conducted and samples of blood, urine, saliva and DNA will be collected. Recruitment feasibility and retention rates will be assessed. Women who become pregnant will be recalled for pregnancy and postpregnancy assessments. Ethics and dissemination The study protocol was approved by South Central Portsmouth REC (Ref: 12/SC/0492). The findings from the study will be disseminated through peer reviewed journals, national and international conference presentations and public events. Trial registration number http://www.clinicaltrials.gov; NCT02419898. PMID:26553837

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

    PubMed Central

    2014-01-01

    Background 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. Methods/Design 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

  13. Cardiovascular Risk and Its Associated Factors in Health Care Workers in Colombia: A Study Protocol

    PubMed Central

    2015-01-01

    Background Cardiovascular diseases are the leading cause of mortality worldwide, for this reason, they are a public health problem. In Colombia, cardiovascular diseases are the main cause of mortality, having a death rate of 152 deaths per 100,000 population. There are 80% of these cardiovascular events that are considered avoidable. Objective The objective of the study is to determine the prevalence of the cardiovascular risk and its associated factors among the institution’s workers in order to design and implement interventions in the work environment which may achieve a decrease in such risk. Methods An analytical cross-sectional study was designed to determine the cardiovascular risk and its associated factors among workers of a high complexity health care institution. A self-applied survey will be conducted considering sociodemographic aspects, physical activity, diet, alcohol consumption, smoking, level of perceived stress, and personal and family history. In a second appointment, a physical examination will be made, as well as anthropometric measurements and blood pressure determination. Also, blood samples for evaluating total and high density lipoprotein cholesterol, triglycerides, and fasting blood sugar will be taken. A ten-year global risk for cardiovascular disease will be determined using the Framingham score. A descriptive analysis of the population’s characteristics and a stratified analysis by sex, age, and occupation will be made. Bivariate and multivariate analysis will be made using logistic regression models to evaluate the association between cardiovascular risk and the independent variables. The research protocol was approved by the Scientific and Technical Committee and the Ethics Committee on Research of the Fundación Cardiovascular de Colombia. Results The protocol has already received funding and the enrollment phase will begin in the coming months. Conclusions The results of this study will give the foundation for the design

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

    PubMed Central

    2011-01-01

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

  15. Study protocol: longitudinal study of the transition of young people with complex health needs from child to adult health services

    PubMed Central

    2013-01-01

    Background Young people with complex health needs have impairments that can limit their ability to carry out day-to-day activities. As well as coping with other developmental transitions, these young people must negotiate the transfer of their clinical care from child to adult services. The process of transition may not be smooth and both health and social outcomes may suffer. Increasingly, policy-makers have recognised the need to ensure a smoother transition between children’s and adult services, with processes that are holistic, individualised, and person-centred; however, there is little outcome data to support proposed models of care. This study aims to identify the features of transitional care that are potentially effective and efficient for young people with complex health needs making their transition. Methods/Design Longitudinal cohort study. 450 young people aged 14 years to 18 years 11 months (with autism spectrum disorder and an additional mental health problem, cerebral palsy or diabetes) will be followed through their transition from child to adult services and will contribute data at baseline, 12, 24 and 36 months. We will collect data on: health and wellbeing outcomes (participation, quality of life, satisfaction with services, generic health status (EQ-5D-Y) and condition specific measure of disease control or management); exposure to proposed beneficial features of services (such as having a key worker, appropriate involvement of parents); socio-economic characteristics of the sample; use of condition-related health and personal social services; preferences for the characteristics of transitional care. We will us regression techniques to explore how outcomes vary by exposure to service features and by characteristics of the young people. These data will populate a decision-analytic model comparing the costs and benefits of potential alternative ways of organising transition services. In order to better understand mechanisms and aid

  16. A Checklist for the Conduct, Reporting, and Appraisal of Microcosting Studies in Health Care: Protocol Development

    PubMed Central

    Reiff, Marian

    2016-01-01

    Background Microcosting is a cost estimation method that requires the collection of detailed data on resources utilized, and the unit costs of those resources in order to identify actual resource use and economic costs. Microcosting findings reflect the true costs to health care systems and to society, and are able to provide transparent and consistent estimates. Many economic evaluations in health and medicine use charges, prices, or payments as a proxy for cost. However, using charges, prices, or payments rather than the true costs of resources can result in inaccurate estimates. There is currently no existing checklist or guideline for the conduct, reporting, or appraisal of microcosting studies in health care interventions. Objective The aim of this study is to create a checklist and guideline for the conduct, reporting, and appraisal of microcosting studies in health care interventions. Methods Appropriate potential domains and items will be identified through (1) a systematic review of all published microcosting studies of health and medical interventions, strategies, and programs; (2) review of published checklists and guidelines for economic evaluations of health interventions, and selection of items relevant for microcosting studies; and (3) theoretical analysis of economic concepts relevant for microcosting. Item selection, formulation, and reduction will be conducted by the research team in order to develop an initial pool of items for evaluation by an expert panel comprising individuals with expertise in microcosting and economic evaluation of health interventions. A modified Delphi process will be conducted to achieve consensus on the checklist. A pilot test will be conducted on a selection of the articles selected for the previous systematic review of published microcosting studies. Results The project is currently in progress. Conclusions Standardization of the methods used to conduct, report or appraise microcosting studies will enhance the

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

    PubMed Central

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

    2013-01-01

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

  18. Factors influencing social and health outcomes after motor vehicle crash injury: an inception cohort study protocol

    PubMed Central

    2014-01-01

    Background There is growing evidence that health and social outcomes following motor vehicle crash injury are related to cognitive and emotional responses of the injured individual, as well as relationships between the injured individual and the compensation systems with which they interact. As most of this evidence comes from other states in Australia or overseas, investigation is therefore warranted to identify the key determinants of health and social outcomes following injury in the context of the New South Wales motor accident insurance scheme. Methods/Design In this inception cohort study, 2400 participants, aged 17 years or more, injured in a motor vehicle crash in New South Wales will be identified though hospital emergency departments, general and physiotherapy practitioners, police records and a government insurance regulator database. Participants will be initially contacted through mail. Baseline interviews will be conducted by telephone within 28 days of the injury and participants will be followed up with interviews at 6, 12 and 24 months post-injury. Health insurance and pharmaceutical prescription data will also be collected. Discussion The study results will report short and long term health and social outcomes in the study sample. Identification of factors associated with health and social outcomes following injury, including related compensation factors will provide evidence for improved service delivery, post-injury management, and inform policy development and reforms. Trial registration Australia New Zealand Clinical trial registry identification number - ACTRN12613000889752. Available at: ANZCTR Registered FISH Study. PMID:24564821

  19. Micro-costing studies in the health and medical literature: protocol for a systematic review

    PubMed Central

    2014-01-01

    Background Micro-costing is a cost estimation method that allows for precise assessment of the economic costs of health interventions. It has been demonstrated to be particularly useful for estimating the costs of new interventions, for interventions with large variability across providers, and for estimating the true costs to the health system and to society. However, existing guidelines for economic evaluations do not provide sufficient detail of the methods and techniques to use when conducting micro-costing analyses. Therefore, the purpose of this study is to review the current literature on micro-costing studies of health and medical interventions, strategies, and programs to assess the variation in micro-costing methodology and the quality of existing studies. This will inform current practice in conducting and reporting micro-costing studies and lead to greater standardization in methodology in the future. Methods/Design We will perform a systematic review of the current literature on micro-costing studies of health and medical interventions, strategies, and programs. Using rigorously designed search strategies, we will search Ovid MEDLINE, EconLit, BIOSIS Previews, Embase, Scopus, and the National Health Service Economic Evaluation Database (NHS EED) to identify relevant English-language articles. These searches will be supplemented by a review of the references of relevant articles identified. Two members of the review team will independently extract detailed information on the design and characteristics of each included article using a standardized data collection form. A third reviewer will be consulted to resolve discrepancies. We will use checklists that have been developed for critical appraisal of health economics studies to evaluate the quality and potential risk of bias of included studies. Discussion This systematic review will provide useful information to help standardize the methods and techniques for conducting and reporting micro

  20. The OPtimising HEalth LIterAcy (Ophelia) process: study protocol for using health literacy profiling and community engagement to create and implement health reform

    PubMed Central

    2014-01-01

    Background Health literacy is a multi-dimensional concept comprising a range of cognitive, affective, social, and personal skills and attributes. This paper describes the research and development protocol for a large communities-based collaborative project in Victoria, Australia that aims to identify and respond to health literacy issues for people with chronic conditions. The project, called Ophelia (OPtimising HEalth LIterAcy) Victoria, is a partnership between two universities, eight service organisations and the Victorian Government. Based on the identified issues, it will develop and pilot health literacy interventions across eight disparate health services to inform the creation of a health literacy response framework to improve health outcomes and reduce health inequalities. Methods/Design The protocol draws on many inputs including the experience of the partners in previous co-creation and roll-out of large-scale health-promotion initiatives. Three key conceptual models/discourses inform the protocol: intervention mapping; quality improvement collaboratives, and realist synthesis. The protocol is outcomes-oriented and focuses on two key questions: ‘What are the health literacy strengths and weaknesses of clients of participating sites?’, and ‘How do sites interpret and respond to these in order to achieve positive health and equity outcomes for their clients?’. The process has six steps in three main phases. The first phase is a needs assessment that uses the Health Literacy Questionnaire (HLQ), a multi-dimensional measure of health literacy, to identify common health literacy needs among clients. The second phase involves front-line staff and management within each service organisation in co-creating intervention plans to strategically respond to the identified local needs. The third phase will trial the interventions within each site to determine if the site can improve identified limitations to service access and/or health outcomes. Discussion

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

    PubMed Central

    2012-01-01

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

  2. Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility study

    PubMed Central

    Marcano-Belisario, José S; Gupta, Ajay K; O'Donoghue, John; Morrison, Cecily; Car, Josip

    2016-01-01

    Introduction Depression is one of the most common mental health disorders that may affect women during pregnancy. The prompt identification of this disorder, and the provision of treatment, may help to reduce the likelihood of post-partum depression, prevent severe forms of the disease, and reduce its intergenerational impact. Despite women's repeated encounters with health services throughout their antenatal care, depression often goes undiagnosed. This is one area where mobile health could prove useful. We will assess the feasibility of using tablets to incorporate depression screening into antenatal pathways. We will also assess if survey layout could affect the quality of the data collected through these devices. Methods and analysis We will test the feasibility of using iPad Airs for the administration of the Whooley questions and the Edinburgh Postnatal Depression Scale (EPDS) to pregnant women attending antenatal clinics in England. We will assess the impact of survey layout on the quality of the responses given to these screening scales using a parallel, randomised controlled study design. We will calculate the positive predictive value, the negative predictive value and the false omission rate of the Whooley questions in comparison with the EPDS. We will calculate differences in data equivalence, time needed to complete the surveys, break-off rates, data completeness and requests for help between the 2 experimental groups: using all questions in one screen and navigation by vertical scrolling, or a single question per screen and navigation by multiple pages. Ethics and dissemination This study has been approved by the National Research Ethics Service Committee South East Coast—Surrey. Our findings will be disseminated through academic peer-reviewed publications, conferences and discussion with peers. PMID:26801468

  3. The ASTUTE Health study protocol: Deliberative stakeholder engagements to inform implementation approaches to healthcare disinvestment

    PubMed Central

    2012-01-01

    Background 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. Methods/design 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. Discussion 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

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

    PubMed Central

    2012-01-01

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

  5. A National Surveillance Survey on Noncommunicable Disease Risk Factors: Suriname Health Study Protocol

    PubMed Central

    Smits, Christel CF; Jaddoe, Vincent WV; Hofman, Albert; Toelsie, Jerry R

    2015-01-01

    Background Noncommunicable diseases (NCDs) are the leading cause of death in low- and middle-income countries. Therefore, the surveillance of risk factors has become an issue of major importance for planning and implementation of preventive measures. Unfortunately, in these countries data on NCDs and their risk factors are limited. This also prevails in Suriname, a middle-income country of the Caribbean, with a multiethnic/multicultural population living in diverse residential areas. For these reasons, “The Suriname Health Study” was designed. Objective The main objective of this study is to estimate the prevalence of NCD risk factors, including metabolic syndrome, hypertension, and diabetes in Suriname. Differences between specific age groups, sexes, ethnic groups, and geographical areas will be emphasized. In addition, risk groups will be identified and targeted actions will be designed and evaluated. Methods In this study, several methodologies were combined. A stratified multistage cluster sample was used to select the participants of 6 ethnic groups (Hindustani, Creole, Javanese, Maroon, Chinese, Amerindians, and mixed) divided into 5 age groups (between 15 and 65 years) who live in urban/rural areas or the hinterland. A standardized World Health Organization STEPwise approach to surveillance questionnaire was adapted and used to obtain information about demographic characteristics, lifestyle, and risk factors. Physical examinations were performed to measure blood pressure, height, weight, and waist circumference. Biochemical analysis of collected blood samples evaluated the levels of glucose, high-density-lipoprotein cholesterol, total cholesterol, and triglycerides. Statistical analysis will be used to identify the burden of modifiable and unmodifiable risk factors in the aforementioned subgroups. Subsequently, tailor-made interventions will be prepared and their effects will be evaluated. Results The data as collected allow for national inference and

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

    PubMed Central

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

    2016-01-01

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

  7. South Yorkshire Cohort: a 'cohort trials facility' study of health and weight - Protocol for the recruitment phase

    PubMed Central

    2011-01-01

    Background Growing levels of both obesity and chronic disease in the general population pose a major public health problem. In the UK, an innovative 'health and weight' cohort trials facility, the 'South Yorkshire Cohort', is being built in order to provide robust evidence to inform policy, commissioning and clinical decisions in this field. This protocol reports the design of the facility and outlines the recruitment phase methods. Method/Design The South Yorkshire Cohort health and weight study uses the cohort multiple randomised controlled trial design. This design recruits a large observational cohort of patients with the condition(s) of interest which then provides a facility for multiple randomised controlled trials (with large representative samples of participants, long term outcomes as standard, increased comparability between each trial conducted within the cohort and increased efficiency particularly for trials of expensive interventions) as well as ongoing information as to the natural history of the condition and treatment as usual. This study aims to recruit 20,000 participants to the population based South Yorkshire Cohort health and weight research trials facility. Participants are recruited by invitation letters from their General Practitioners. Data is collected using postal and/or online patient self completed Health Questionnaires. NHS numbers will be used to facilitate record linkage and access to routine data. Participants are eligible if they are: aged 16 - 85 years, registered with one of 40 practices in South Yorkshire, provide consent for further contact from the researchers and to have their information used to look at the benefit of health treatments. The first wave of data is being collected during 2010/12 and further waves are planned at 2 - 5 year intervals for the planned 20 year duration of the facility. Discussion The South Yorkshire Cohort combines the strengths of the standard observational, longitudinal cohort study design with

  8. How to Find Lessons from the Public Health Literature: Example of a Scoping Study Protocol on the Neighborhood Environment

    PubMed Central

    Levasseur, Mélanie; Généreux, Mélissa; Desroches, Josiane; Carrier, Annie; Lacasse, Francis; Chabot, Éric; Abecia, Ana; Gosselin, Louise; Vanasse, Alain

    2016-01-01

    Background: As key determinants of many favorable health and quality of life outcomes, it is important to identify factors associated with mobility and social participation. Although several investigations have been carried out on mobility, social participation and neighborhood environment, there is no clear integration of these results. This paper presents a scoping study protocol that aims to provide a comprehensive understanding of how the physical and social neighborhood environment is associated with or influences mobility and social participation in older adults. Methods: The rigorous methodological framework for scoping studies is used to synthesize and disseminate current knowledge on the associations or influence of the neighborhood environment on mobility and social participation in aging. Nine databases from public health and other fields are searched with 51 predetermined keywords. Using content analysis, all data are exhaustively analyzed, organized, and synthesized independently by two research assistants. Discussion: A comprehensive synthesis of empirical studies provides decision-makers, clinicians and researchers with current knowledge and best practices regarding neighborhood environments with a view to enhancing mobility and social participation. Such a synthesis represents an original contribution and can ultimately support decisions and development of innovative interventions and clear guidelines for the creation of age-supportive environments. Improvements in public health and clinical interventions might be the new innovation needed to foster health and quality of life for aging population. Finally, the aspects of the associations or influence of the neighborhood environment on mobility and social participation not covered by previous research are identified. Conclusions: Among factors that impact mobility and social participation, the neighborhood environment is important since interventions targeting it may have a greater impact on an

  9. Nutrition, environment and cardiovascular health (NESCAV): protocol of an inter-regional cross-sectional study

    PubMed Central

    2010-01-01

    Background Despite the remarkable technological progress in health care and treatment, cardiovascular disease remains the leading cause of premature death, prolonged hospitalization and disability in most European countries. In the population of the Greater Region (Grand-Duchy of Luxembourg, Wallonia in Belgium, and Lorraine in France), the prevalence of cardiovascular risk factors and disease is among the highest in Europe, warranting the need for a better understanding of factors contributing to this pattern. In this context, the cross-border "Nutrition, Environment and Cardiovascular Health-NESCAV" project is initiated by an inter-regional multi-disciplinary consortium and supported by the INTERREG IV A program "Greater Region", 2007-2013, to fight synergically and harmoniously against this major public health problem. Methods/design The objectives of the three-year planned project are to assess, in a representative sample of 3000 randomly selected individuals living at the Greater Region, 1) the cardiovascular health and risk profile, 2) the association between the dietary habits and the cardiovascular risk, 3) the association of occupational and environmental pollution markers with the cardiovascular risk, 4) the knowledge, awareness and level of control of cardiovascular risk factors, 5) the potential gaps in the current primary prevention, and finally, to address evidence-based recommendations enabling the development of inter-regional guidance to help policy-makers and health care workers for the prevention of cardiovascular disease. Discussion The findings will provide tools that may enable the Greater Region's decision-makers and health professionals to implement targeted and cost-effective prevention strategies. PMID:21078172

  10. Improving health-related fitness in children: the fit-4-Fun randomized controlled trial study protocol

    PubMed Central

    2011-01-01

    Background Declining levels of physical fitness in children are linked to an increased risk of developing poor physical and mental health. Physical activity programs for children that involve regular high intensity physical activity, along with muscle and bone strengthening activities, have been identified by the World Health Organisation as a key strategy to reduce the escalating burden of ill health caused by non-communicable diseases. This paper reports the rationale and methods for a school-based intervention designed to improve physical fitness and physical activity levels of Grades 5 and 6 primary school children. Methods/Design Fit-4-Fun is an 8-week multi-component school-based health-related fitness education intervention and will be evaluated using a group randomized controlled trial. Primary schools from the Hunter Region in NSW, Australia, will be invited to participate in the program in 2011 with a target sample size of 128 primary schools children (age 10-13). The Fit-4-Fun program is theoretically grounded and will be implemented applying the Health Promoting Schools framework. Students will participate in weekly curriculum-based health and physical education lessons, daily break-time physical activities during recess and lunch, and will complete an 8-week (3 × per week) home activity program with their parents and/or family members. A battery of six health-related fitness assessments, four days of pedometery-assessed physical activity and a questionnaire, will be administered at baseline, immediate post-intervention (2-months) and at 6-months (from baseline) to determine intervention effects. Details of the methodological aspects of recruitment, inclusion criteria, randomization, intervention program, assessments, process evaluation and statistical analyses are described. Discussion The Fit-4-Fun program is an innovative school-based intervention targeting fitness improvements in primary school children. The program will involve a range of evidence

  11. Lumbar spinal fusion patients' demands to the primary health sector: evaluation of three rehabilitation protocols. A prospective randomized study.

    PubMed

    Soegaard, Rikke; Christensen, Finn B; Lauerberg, Ida; Lauersen, Ida; Bünger, Cody E

    2006-05-01

    Very few studies have investigated the effects or costs of rehabilitation regimens following lumbar spinal fusion. The effectiveness of in-hospital rehabilitation regimens has substantial impact on patients' demands in the primary health care sector. The aim of this study was to investigate patient-articulated demands to the primary health care sector following lumbar spinal fusion and three different in-hospital rehabilitation regimens in a prospective, randomized study with a 2-year follow-up. Ninety patients were randomized 3 months post lumbar spinal fusion to either a 'video' group (one-time oral instruction by a physiotherapist and patients were then issued a video for home exercise), or a 'café' group (video regimen with the addition of three café meetings with other fusion-operated patients) or a 'training' group (exercise therapy; physiotherapist-guided; two times a week for 8 weeks). Register data of service utilization in the primary health care sector were collected from the time of randomization through 24 months postsurgery. Costs of in-hospital protocols were estimated and the service utilization in the primary health care sector and its cost were analyzed. A significant difference (P=0.023) in number of contacts was found among groups at 2-year follow-up. Within the periods of 3-6 months and 7-12 months postoperatively, the experimental groups required less than half the amount of care within the primary health care sector as compared to the video group (P=0.001 and P=0.008). The incremental costs of the café regimen respectively, the training regimen were compensated by cost savings in the primary health care sector, at ratios of 4.70 (95% CI 4.64; 4.77) and 1.70 (95% CI 1.68; 1.72). This study concludes that a low-cost biopsychosocial rehabilitation regimen significantly reduces service utilization in the primary health care sector as compared to the usual regimen and a training exercise regimen. The results stress the importance of a cognitive

  12. Health and development of ART conceived young adults: a study protocol for the follow-up of a cohort

    PubMed Central

    2013-01-01

    Background Use of assisted reproductive technologies (ART) continues to increase, yet little is known of the longer term health of ART conceived offspring. There are some adverse birth outcomes associated with ART conception but the subsequent developmental trajectory is unclear. Undertaking research in this area is challenging due the sensitive nature of the topic and the time elapsed since birth of the ART conceived young adults. The aim of this report is to describe a research protocol, including design and ethical considerations, used to compare the physical and psychosocial health outcomes of ART conceived young adults aged 18-28 years, with their spontaneously conceived peers. Design This is a retrospective cohort study of mothers who conceived with ART in Victoria, Australia and gave birth to a singleton child between 1982 and 1992. A current address for each mother was located and a letter of invitation to participate in the study was sent by registered mail. Participation involved completing a telephone interview about her young adult offspring’s health and development from birth to the present. Mothers were also asked for consent for the researcher to contact their son/daughter to invite them to complete a structured telephone interview about their physical and psychosocial health. A comparison group of women living in Victoria, Australia, who had given birth to a spontaneously conceived singleton child between 1982 and 1992 was recruited from the general population using random digit dialling. Data were collected from them and their young adult offspring in the same way. Regression analyses were used to evaluate relationships between ART exposure and health status, including birth defects, chronic health conditions, hospital admissions, growth and sexual development. Psychosocial wellbeing, parental relationships and educational achievement were also assessed. Factors associated with the age of disclosure of ART conception were explored with the ART

  13. Birth cohort study on the effects of desert dust exposure on children's health: protocol of an adjunct study of the Japan Environment & Children’s Study

    PubMed Central

    Kanatani, Kumiko T; Adachi, Yuichi; Sugimoto, Nobuo; Noma, Hisashi; Onishi, Kazunari; Hamazaki, Kei; Takahashi, Yoshimitsu; Ito, Isao; Egawa, Miho; Sato, Keiko; Go, Tohshin; Kurozawa, Youichi; Inadera, Hidekuni; Konishi, Ikuo; Nakayama, Takeo

    2014-01-01

    Introduction Desert dust is estimated to constitute about 35% of aerosol in the troposphere. Desertification, climatic variability and global warming all can contribute to increased dust formation. This study aims to examine possible health effects of desert dust exposure on pregnant women and their children. The purpose of this report was to present the study protocol. Methods and analysis This 4-year birth cohort study began in 2011 as an adjunct study of the Japan Environment & Children’s Study (JECS) involving three regions: Kyoto, Toyama and Tottori. The JECS participants of the three regions above who also agreed to participate in this adjunct study were enrolled prior to delivery. Light Detecting and Ranging (LIDAR) with a polarisation analyser, which can distinguish mineral dust particles from other particles, is used for exposure measurements. Outcomes are allergic symptoms for mothers and development of asthma and other allergic or respiratory diseases for their children. Data are acquired in a timely manner by connecting local LIDAR equipment to an online questionnaire system. Participants answer the online questionnaire using mobile phones or personal computers. Ethics and dissemination The study protocol was approved by the ethics committees of Kyoto University, University of Toyama and Tottori University. All participants provided written informed consent. The results of this study will be published in peer-reviewed journals and disseminated to the scientific community and general public. Trial Registration number UMIN000010826. PMID:24958210

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

    PubMed Central

    2011-01-01

    Background The study aims to test the differential effects of a web-based text and a web-based video-driven computer-tailored approach for lower socio-economic status (LSES) and higher socio-economic status (HSES) smokers which incorporate multiple computer-tailored feedback moments. The two programs differ only in the mode of delivery (video- versus text-based messages). The paper aims to describe the development and design of the two computer-tailored programs. Methods/design Respondents who smoked at the time of the study inclusion, who were motivated to quit within the following six months and who were aged 18 or older were included in the program. The study is a randomized control trial with a 2 (video/text) * 2(LSES/HSES) design. Respondents were assigned either to one of the intervention groups (text versus video tailored feedback) or to the control group (non-tailored generic advice). In all three conditions participants were asked to fill in the baseline questionnaire based on the I-Change model. The questionnaire assessed socio-demographics, attitude towards smoking, knowledge, self-efficacy, social influence, depression, level of addiction, action planning, goal actions, intention to quit smoking, seven-day point prevalence and continued abstinence. Follow-up measurements were conducted at six and twelve months after baseline. Discussion The present paper describes the development of the two computer-tailored smoking cessation programs, their components and the design of the study. The study results reveal different working mechanisms of multiple tailored smoking cessation interventions and will help us to gain more insight into effective strategies to target different subgroups, especially smokers with a lower socio-economic status. Trial registration Dutch Trial Register NTR3102 PMID:22059446

  15. Testing Activity Monitors’ Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients

    PubMed Central

    Ottenbacher, Kenneth J; Fisher, Steve R; Jennings, Kristofer; Brown, Arleen F; Swartz, Maria C; Lyons, Elizabeth J

    2016-01-01

    Background Cardiovascular disease is the leading cause of mortality in the United States. Maintaining healthy levels of physical activity is critical to cardiovascular health, but many older adults are inactive. There is a growing body of evidence linking low motivation and inactivity. Standard behavioral counseling techniques used within the primary care setting strive to increase motivation, but often do not emphasize the key component of self-control. The addition of electronic activity monitors (EAMs) to counseling protocols may provide more effective behavior change and increase overall motivation for exercise through interactive self-monitoring, feedback, and social support from other users. Objective The objective of the study is to conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (n=40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Methods Throughout the intervention, we will test its feasibility and acceptability, the change in primary outcomes (cardiovascular risk and physical activity), and the change in secondary outcomes (adherence, weight and body composition, health status, motivation, physical function, psychological feelings, and self-regulation). Upon completion of the intervention, we will also conduct focus groups with the participants and with primary care stakeholders. Results The study started recruitment in October 2015 and is scheduled to be completed by October 2016. Conclusions This project will lay the groundwork and establish the infrastructure for intervention refinement and ultimately translation within the primary care setting in order to prevent cardiovascular disease on a population level. Trial Registration ClinicalTrails.gov NCT02554435; https://clinicaltrials.gov/ct2/show/NCT02554435 (Archived by WebCite at http://www.webcitation/6fUlW5tdT) PMID:27129602

  16. A study protocol for applying the co-creating knowledge translation framework to a population health study

    PubMed Central

    2013-01-01

    Background Population health research can generate significant outcomes for communities, while Knowledge Translation (KT) aims to expressly maximize the outcomes of knowledge producing activity. Yet the two approaches are seldom explicitly combined as part of the research process. A population health study in Port Lincoln, South Australia offered the opportunity to develop and apply the co-KT Framework to the entire research process. This is a new framework to facilitate knowledge formation collaboratively between researchers and communities throughout a research to intervention implementation process. Design This study employs a five step framework (the co-KT Framework) that is formulated from engaged scholarship and action research principles. By following the steps a knowledge base will be cumulatively co-created with the study population that is useful to the research aims. Step 1 is the initiating of contact between the researcher and the study contexts, and the framing of the research issue, achieved through a systematic data collection tool. Step 2 refines the research issue and the knowledge base by building into it context specific details and conducting knowledge exchange events. Step 3 involves interpreting and analysing the knowledge base, and integrating evidence to inform intervention development. In Step 4 the intervention will be piloted and evaluated. Step 5 is the completion of the research process where outcomes for improvement will be instituted as regular practice with the facilitation of the community. In summary, the model uses an iterative knowledge construction mechanism that is complemented by external evidence to design interventions to address health priorities within the community. Discussion This is a systematic approach that operationalises the translational cycle using a framework for KT practice. It begins with the local context as its foundation for knowledge creation and ends with the development of contextually applicable

  17. Study protocol: effects of the THAO-child health intervention program on the prevention of childhood obesity - The POIBC study

    PubMed Central

    2014-01-01

    Background The speeding increase and the high prevalence of childhood obesity is a serious problem for Public Health. Community Based Interventions has been developed to combat against the childhood obesity epidemic. However little is known on the efficacy of these programs. Therefore, there is an urgent need to determine the effect of community based intervention on changes in lifestyle and surrogate measures of adiposity. Methods/design Parallel intervention study including two thousand 2249 children aged 8 to 10 years ( 4th and 5th grade of elementary school) from 4 Spanish towns. The THAO-Child Health Program, a community based intervention, were implemented in 2 towns. Body weight, height, and waist circumferences were measured. Children recorded their dietary intake on a computer-based 24h recall. All children also completed validated computer based questionnaires to estimate physical activity, diet quality, eating behaviors, and quality of life and sleep. Additionally, parental diet quality and physical activity were assessed by validated questionnaires. Discussion This study will provide insight in the efficacy of the THAO-Child Health Program to promote a healthy lifestyle. Additionally it will evaluate if lifestyle changes are accompanied by favorable weight management. Trial registration Trial Registration Number ISRCTN68403446 PMID:25174356

  18. The German MultiCare-study: Patterns of multimorbidity in primary health care – protocol of a prospective cohort study

    PubMed Central

    2009-01-01

    Background Multimorbidity is a highly frequent condition in older people, but well designed longitudinal studies on the impact of multimorbidity on patients and the health care system have been remarkably scarce in numbers until today. Little is known about the long term impact of multimorbidity on the patients' life expectancy, functional status and quality of life as well as health care utilization over time. As a consequence, there is little help for GPs in adjusting care for these patients, even though studies suggest that adhering to present clinical practice guidelines in the care of patients with multimorbidity may have adverse effects. Methods/Design The study is designed as a multicentre prospective, observational cohort study of 3.050 patients aged 65 to 85 at baseline with at least three different diagnoses out of a list of 29 illnesses and syndromes. The patients will be recruited in approx. 120 to 150 GP surgeries in 8 study centres distributed across Germany. Information about the patients' morbidity will be collected mainly in GP interviews and from chart reviews. Functional status, resources/risk factors, health care utilization and additional morbidity data will be assessed in patient interviews, in which a multitude of well established standardized questionnaires and tests will be performed. Discussion The main aim of the cohort study is to monitor the course of the illness process and to analyse for which reasons medical conditions are stable, deteriorating or only temporarily present. First, clusters of combinations of diseases/disorders (multimorbidity patterns) with a comparable impact (e.g. on quality of life and/or functional status) will be identified. Then the development of these clusters over time will be analysed, especially with regard to prognostic variables and the somatic, psychological and social consequences as well as the utilization of health care resources. The results will allow the development of an instrument for prediction

  19. Study of Health and Activity in Preschool Environments (SHAPES): Study protocol for a randomized trial evaluating a multi-component physical activity intervention in preschool children

    PubMed Central

    2013-01-01

    Background Physical inactivity is a recognized public health concern. Inadequate proportions of children in the U.S, including those of preschool age, are meeting physical activity recommendations. In response to low numbers of preschool children attaining appropriate physical activity levels, combined with the large number of young children who attend preschool, researchers have identified the need to devise interventions to increase physical activity at preschools. However, few multi-component interventions to increase physical activity in preschool children exist. The aims of this study were to observe the effects of a multi-component intervention on physical activity, sedentary behavior, and physical activity energy expenditure in 3-5 year-old children; identify factors that associate with change in those variables; and evaluate the process of implementing the multi-component intervention. The purpose of this manuscript is to describe the study design and intervention protocol. Methods/design The overall design of the Study of Health and Activity in Preschool Environments (SHAPES) was a two-year randomized trial (nested cohort design), with two conditions, two measurement occasions, and preschool serving as the unit of analysis. Sixteen schools (eight intervention and eight control) were enrolled. The intervention protocol was based on the social ecological model and included four main components: (a) indoor physical activity (“move inside”), (b) recess (“move outside”), (c) daily lessons (“move to learn”), and (d) social environment. Components were implemented using teacher and administrator trainings and workshops, site support visits, newsletters, and self-monitoring methods. Outcomes included accelerometer assessment of physical activity, sedentary behavior, and physical activity energy expenditure; weight status; and demographic factors; family/home social and physical environment; and parental characteristics. An extensive process evaluation

  20. Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t’ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. Method/design This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health

  1. Development of a Health Empowerment Programme to improve the health of working poor families: protocol for a prospective cohort study in Hong Kong

    PubMed Central

    Fung, Colman Siu Cheung; Yu, Esther Yee Tak; Guo, Vivian Yawei; Kung, Kenny; Ho, Sin Yi; Lam, Lai Ying; Ip, Patrick; Fong, Daniel Yee Tak; Lam, David Chi Leung; Wong, William Chi Wai; Tsang, Sandra Kit Man; Tiwari, Agnes Fung Yee; Lam, Cindy Lo Kuen

    2016-01-01

    Introduction People from working poor families are at high risk of poor health partly due to limited healthcare access. Health empowerment, a process by which people can gain greater control over the decisions affecting their lives and health through education and motivation, can be an effective way to enhance health, health-related quality of life (HRQOL), health awareness and health-seeking behaviours of these people. A new cohort study will be launched to explore the potential for a Health Empowerment Programme to enable these families by enhancing their health status and modifying their attitudes towards health-related issues. If proven effective, similar empowerment programme models could be tested and further disseminated in collaborations with healthcare providers and policymakers. Method and analysis A prospective cohort study with 200 intervention families will be launched and followed up for 5 years. The following inclusion criteria will be used at the time of recruitment: (1) Having at least one working family member; (2) Having at least one child studying in grades 1–3; and (3) Having a monthly household income that is less than 75% of the median monthly household income of Hong Kong families. The Health Empowerment Programme that will be offered to intervention families will comprise four components: health assessment, health literacy, self-care enablement and health ambassador. Their health status, HRQOL, lifestyle and health service utilisation will be assessed and compared with 200 control families with matching characteristics but will not receive the health empowerment intervention. Ethics and dissemination This project was approved by the University of Hong Kong—the Hospital Authority Hong Kong West Cluster IRB, Reference number: UW 12-517. The study findings will be disseminated through a series of peer-reviewed publications and conference presentations, as well as a yearly report to the philanthropic funding body–Kerry Group Kuok

  2. Effectiveness of a multiple-strategy community intervention to reduce maternal and child health inequalities in Haryana, North India: a mixed-methods study protocol

    PubMed Central

    Gupta, Madhu; Angeli, Federica; van Schayck, Onno C. P.; Bosma, Hans

    2015-01-01

    Background A multiple-strategy community intervention, known as National Rural Health Mission (NRHM), launched in India to improve the availability of and access to better-quality healthcare, especially for rural, poor mothers and children. The final goal of the intervention is to reduce maternal and child health inequalities across geographical areas, socioeconomic status groups, and sex of the child. Extensive, in-depth research is necessary to assess the effectiveness of NRHM, on multiple outcome dimensions. This paper presents the design of a new study, able to overcome the shortcomings of previous research. Objective To propose a comprehensive, methodologically sound protocol to assess the extent of implementation and the effectiveness of NRHM measures to improve maternal and child health outcomes and reduce maternal and child health inequalities. Design A mixed-methods approach (quantitative and qualitative) is proposed for this study in Haryana, a state in North India. NRHM's health sector plans included health system strengthening, specific maternal and child healthcare strategies, and communitization. Mission documents and reports on progress, financial monitoring, and common and joint review will be reviewed in-depth to assess the extent of the implementation of plans. Data on maternal and child health indicators will be obtained from demographic health surveys held before, during, and after the implementation of the first phase of the NRHM (2005–2012) and compared over time. Differences in maternal and child health indicators will be used to measure maternal and child health inequalities; these will be compared pre- and post-NRHM. Focus group discussions (FGDs) with service providers and in-depth interviews with program managers, community representatives, and mothers will be conducted until data saturation is achieved, in two districts of Haryana. Using Nvivo software, an inductive qualitative content analysis will be performed to search for the

  3. Longitudinal measurement of cortisol in association with mental health and experience of domestic violence and abuse: study protocol

    PubMed Central

    2013-01-01

    Background Domestic violence and abuse is threatening behavior, violence/abuse used by one person to control the other within an intimate or family-type relationship. Women experience more severe physical and sexual domestic violence and abuse and more mental health consequences than men. The current study aims at exploring of the role of hypothalamic-pituitary-adrenocortical axis activity in abuse impact on women's mental health. Study objectives: 1) To evaluate diurnal cortisol slope, cortisol awakening response, and the mean cortisol concentration in women with a current or recent experience of abuse; 2) To estimate whether cortisol secretion is associated with type, severity, duration and cessation of abuse; 3) To investigate whether cortisol acts as mediator between abuse and mental health condition; 4) To examine whether there is any distinction in cortisol levels between those women exposed to both childhood abuse and domestic violence and abuse and those experienced only the latter. 4) To explore whether cortisol secretion differs between women living in refuge and those still living in the community. Methods/Design To meet study objectives 128 women will be recruited in a domestic violence agency and local communities. Baseline and 3-month follow-up measures will be taken over 6 months after recruitment. Each assessment will include: (1) standardized self-administered questionnaires to evaluate socio-demographics, experience of violence and abuse, mental and physical health; (2) weight and height measurement; (3) self-completion of wakening, post-wakening and evening saliva samples. Saliva will be analysed for cortisol and cortisone using Ultra performance liquid chromatography – tandem mass spectrometry. We will compare diurnal cortisol parameters between non-abused controls and abuse survivors with and without mental health conditions. First following descriptive statistics for all the cortisol and mental health outcomes, relationships between them

  4. Evaluating the accessibility and utility of HIV-related point-of-care diagnostics for maternal health in rural South Africa: a study protocol

    PubMed Central

    Mashamba-Thompson, T P; Drain, P K; Sartorius, B

    2016-01-01

    Introduction Poor healthcare access is a major barrier to receiving antenatal care and a cause of high maternal mortality in South Africa (SA). ‘Point-of-care’ (POC) diagnostics is a powerful emerging healthcare approach to improve healthcare access. This study focuses on evaluating the accessibility and utility of POC diagnostics for maternal health in rural SA primary healthcare (PHC) clinics in order to generate a model framework of implementation of POC diagnostics in rural South African clinics. Method and analyses We will use several research methods, including a systematic review, quasi-experiments, survey, key informant interviews and audits. We will conduct a systematic review and experimental study to determine the impact of POC diagnostics on maternal health. We will perform a cross-sectional case study of 100 randomly selected rural primary healthcare clinics in KwaZulu-Natal to measure the context and patterns of POC diagnostics access and usage by maternal health providers and patients. We will conduct interviews with relevant key stakeholders to determine the reasons for POC deficiencies regarding accessibility and utility of HIV-related POC diagnostics for maternal health. We will also conduct a vertical audit to investigate all the quality aspects of POC diagnostic services including diagnostic accuracy in a select number of clinics. On the basis of information gathered, we will propose a model framework for improved implementation of POC diagnostics in rural South African public healthcare clinics. Statistical (Stata-13) and thematic (NVIVO) data analysis will be used in this study. Ethics and dissemination The study protocol was approved by the Ethics Committee of the University of KwaZulu-Natal (BE 484/14) and the KwaZulu-Natal Department of Health based on the Helsinki Declaration (HRKM 40/15). Findings of this study will be disseminated electronically and in print. They will be presented to conferences related to HIV/AIDS, diagnostics

  5. Study Protocol on Ecological Momentary Assessment of Health-Related Quality of Life Using a Smartphone Application.

    PubMed

    Mareva, Silvana; Thomson, David; Marenco, Pietro; Estal Muñoz, Víctor; Ott, Caroline V; Schmidt, Barbara; Wingen, Tobias; Kassianos, Angelos P

    2016-01-01

    -time and retrospective measures in this study will provide important novel insight into the efficacy of mHealth applications for HRQoL assessment. If shown to be valid, reliable and feasible for the collection of HRQoL data, mHealth applications may have future potential for facilitating clinical assessment, patient-physician communication, and monitoring individual HRQoL over course of treatment.

  6. Study Protocol on Ecological Momentary Assessment of Health-Related Quality of Life Using a Smartphone Application.

    PubMed

    Mareva, Silvana; Thomson, David; Marenco, Pietro; Estal Muñoz, Víctor; Ott, Caroline V; Schmidt, Barbara; Wingen, Tobias; Kassianos, Angelos P

    2016-01-01

    -time and retrospective measures in this study will provide important novel insight into the efficacy of mHealth applications for HRQoL assessment. If shown to be valid, reliable and feasible for the collection of HRQoL data, mHealth applications may have future potential for facilitating clinical assessment, patient-physician communication, and monitoring individual HRQoL over course of treatment. PMID:27486425

  7. Study Protocol on Ecological Momentary Assessment of Health-Related Quality of Life Using a Smartphone Application

    PubMed Central

    Mareva, Silvana; Thomson, David; Marenco, Pietro; Estal Muñoz, Víctor; Ott, Caroline V.; Schmidt, Barbara; Wingen, Tobias; Kassianos, Angelos P.

    2016-01-01

    -time and retrospective measures in this study will provide important novel insight into the efficacy of mHealth applications for HRQoL assessment. If shown to be valid, reliable and feasible for the collection of HRQoL data, mHealth applications may have future potential for facilitating clinical assessment, patient-physician communication, and monitoring individual HRQoL over course of treatment. PMID:27486425

  8. Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Sepsis sequelae include critical illness polyneuropathy, myopathy, wasting, neurocognitive deficits, post-traumatic stress disorder, depression and chronic pain. Little is known howlong-term sequelae following hospital discharge are treated. The aim of our study is to determine the effect of a primary care-based, long-term program on health-related quality of life in sepsis survivors. Methods/Design In a two-armed randomized multicenter interventional study, patients after sepsis (n = 290) will be assessed at 6, 12 and 24 months. Patients are eligible if severe sepsis or septic shock (ICD-10), at least two criteria of systemic inflammatory response syndrome (SIRS), at least one organ dysfunction and sufficient cognitive capacity are present. The intervention comprises 1) discharge management, 2) training of general practitioners and patients in evidence-based care for sepsis sequelae and 3) telephone monitoring of patients. At six months, we expect an improved primary outcome (health-related quality of life/SF-36) and improved secondary outcomes such as costs, mortality, clinical-, psycho-social- and process-of-care measures in the intervention group compared to the control group. Discussion This study evaluates a primary care-based, long-term program for patients after severe sepsis. Study results may add evidence for improved sepsis care management. General practitioners may contribute efficiently to sepsis aftercare. Trial registration U1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011). PMID:25015838

  9. Study protocol for a controlled trial of Strengths Model Case Management in mental health services in Hong Kong

    PubMed Central

    Tsoi, Wing-See Emily; Tse, Samson; Fukui, Sadaaki; Jones, Steven

    2015-01-01

    Introduction Although strengths-based models are popular within recovery-oriented approaches, there is still a lack of conclusive research to guide how they should be implemented. A recent meta-analysis confirmed the lack of clarity in how this perspective is operationalised and that fidelity monitoring during the implementation process is lacking. Hence, there is a clear need to evaluate the feasibility of delivering and evaluating a clearly operationalised strengths-based intervention that incorporates fidelity checks to inform more definitive research. This protocol therefore describes a controlled trial of Strengths Model Case Management (SMCM), a complex intervention, for people with severe mental illnesses in Hong Kong. This trial follows the guidelines of the Medical Research Council as a phase 2 trial. Hence, it is a pilot study that tests the feasibility and effectiveness of the model. Methods and analysis This is a 9-month controlled trial that uses the Kansas Model. Participants and a matched control group are recruited on a voluntary basis, after screening for eligibility. Effectiveness of the SMCM will be measured through outcome measures taken at baseline, the mid-point and at the end of the trial. Outcomes for service users include personal recovery, hope, subjective well-being, psychiatric symptoms, perceived level of recovery features within the organisation, therapeutic alliance and achievement of recovery goals. Outcomes for care workers will include job burnout, organisational features of recovery and perceived supervisory support. With a 2×3 analysis of variance design and a moderate intervention effect (Cohen's d=0.50), a total of 86 participants will be needed for a statistical power of 0.80. Ethics and dissemination Ethical approval has been obtained from the Human Research Ethics Committee for Non-Clinical Faculties at The University of Hong Kong (HRECNCF: EA140913). Trial registration number Australian New Zealand Clinical Trial Registry

  10. Health-promoting behaviors and social support of women of reproductive age, and strategies for advancing their health: Protocol for a mixed methods study

    PubMed Central

    2011-01-01

    Background Determining the health-promoting behaviors of women during the important period of reproduction provides valuable information for designing appropriate intervention programs for advancing women's health. There is no study on the health-promoting behaviors of women of reproductive age in Iran. Thus, the aim of this study is to explore these health-promoting behaviors for the purpose of developing comprehensive and culturally sensitive health advancement strategies for Iranian women. Methods/Design This study has a sequential explanatory mixed methods design. The follow-up explanation model is used to elaborate the quantitative results by collecting qualitative data from participants who could best assist in elucidating the results. The study is conducted in two sequential phases. The first phase is a population-based cross-sectional survey in which 1350 Iranian women of reproductive age are selected by proportional random multistage cluster sampling of the 22 main municipal sectors of Tehran, Iran. Questionnaires are completed through a face-to-face interview. The second phase is a qualitative study in which participants are selected using purposive sampling in the form of extreme case sampling on the basis of health-promoting behavior scores. The qualitative phase is based on data collected from focus group discussions or individual in-depth interviews. A conventional qualitative content analysis approach is used, and the data are managed with a computer-assisted program. Women's health-promoting strategies are developed using the qualitative and quantitative results, a review of the related literature, and the nominal group technique among experts. Discussion The findings of this mixed methods sequential explanatory study, obtained using a culturally sensitive approach, provide insights into the health behavioral factors that need to be considered if preventive strategies and intervention programs are to be designed to promote women's health in the

  11. Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Long-term sick leave has considerably negative impact on the individual and society. Hence, the need to identify effective occupational rehabilitation programs is pressing. In Norway, group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years, but no rigorous evaluation has been performed. The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs, differing in length and content, with a comparative cognitive intervention. Secondarily the two inpatient programs will be compared with each other, and with a usual care reference group. Methods/design The study is designed as a randomized controlled trial with parallel groups. The Social Security Office performs monthly extractions of sick listed individuals aged 18–60 years, on sick leave 2–12 months, with sick leave status 50% - 100% due to musculoskeletal, mental or unspecific disorders. Sick-listed persons are randomized twice: 1) to receive one of two invitations to participate in the study or not receive an invitation, where the latter “untouched” control group will be monitored for future sick leave in the National Social Security Register, and 2) after inclusion, to a Long or Short inpatient multicomponent rehabilitation program (depending on which invitation was sent) or an outpatient cognitive behavioral therapy group comparative program. The Long program consists of 3 ½ weeks with full rehabilitation days. The Short program consists of 4 + 4 full days, separated by two weeks, in which a workplace visit will be performed if desirable. Three areas of rehabilitation are targeted: mental training, physical training and work-related problem solving. The primary outcome is number of sick leave days. Secondary outcomes include time until full sustainable return to work, health related quality of life, health related behavior, functional status, somatic and

  12. Understanding the impacts of care farms on health and well-being of disadvantaged populations: a protocol of the Evaluating Community Orders (ECO) pilot study

    PubMed Central

    Elsey, H; Bragg, R; Elings, M; Cade, J E; Brennan, C; Farragher, T; Tubeuf, S; Gold, R; Shickle, D; Wickramasekera, N; Richardson, Z; Murray, J

    2014-01-01

    Introduction Care farms, where all or part of the farm is used for therapeutic purposes, show much potential for improving the health and well-being of a range of disadvantaged groups. Studies to date have been qualitative or observational, with limited empirical evidence of the effectiveness of care farms in improving health and well-being. Understanding the underlying mechanisms that lead to improvements for different disadvantaged groups is a further gap in the evidence. Participants in this study are offenders serving community orders. Their low socioeconomic status and poor health outcomes relative to the general population exemplifies disadvantage. Methods and analysis This paper describes the protocol of a study to understand the impacts of care farms and to pilot the design and tools for a study to assess cost-effectiveness of care farms in improving the quality of life of offenders. As a pilot study, no power calculation has been conducted. However, 150 offenders serving community sentences on care farms and 150 on other probation locations (eg, litter picking, painting) will be recruited over a 1-year period. Changes in quality of life, measured by Clinical Outcome in Routine Evaluation–Outcome Measure, health and reconvictions of offenders at care farms compared to other probation locations will be analysed to inform the sample size calculation for the follow on study. The feasibility of recruitment, retention, collecting cost data and modelling cost-effectiveness will also be assessed. The study will use qualitative methods to explore the experiences of offenders attending care farms and perceptions of probation and care farm staff on the processes and impacts of the intervention. Ethics and dissemination Findings will be published and inform development of a natural experiment and will be disseminated to probation services, care farms and academics. University of Leeds Ethical Review Board approved: SoMREC/13/014. National Offender Management Service

  13. EuroQol Protocols for Time Trade-Off Valuation of Health Outcomes.

    PubMed

    Oppe, Mark; Rand-Hendriksen, Kim; Shah, Koonal; Ramos-Goñi, Juan M; Luo, Nan

    2016-10-01

    The time trade-off (TTO) valuation technique is widely used to determine utility values of health outcomes to inform quality-adjusted life-year (QALY) calculations for use in economic evaluation. Protocols for implementing TTO vary in aspects such as the trade-off framework, iteration procedure and its administration model and method, training of respondents and interviewers, and quality control of data collection. The most widely studied and utilized TTO valuation protocols are the Measurement and Valuation of Health (MVH) protocol, the Paris protocol and the EuroQol Valuation Technology (EQ-VT) protocol, all developed by members of the EuroQol Group. The MVH protocol and its successor, the Paris protocol, were developed for valuation of EQ-5D-3L health states. Both protocols were designed for a trained interviewer to elicit preferences from a respondent using the conventional TTO framework with a fixed time horizon of 10 years and an iteration procedure combining bisection and titration. Developed for valuation of EQ-5D-5L health states, the EQ-VT protocol adopted a composite TTO framework and made use of computer technology to facilitate data collection. Training and monitoring of interviewers and respondents is a pivotal component of the EQ-VT protocol. Research is underway aiming to further improve the EuroQol protocols, which form an important basis for the current practice of health technology assessment in many countries. PMID:27084198

  14. EuroQol Protocols for Time Trade-Off Valuation of Health Outcomes.

    PubMed

    Oppe, Mark; Rand-Hendriksen, Kim; Shah, Koonal; Ramos-Goñi, Juan M; Luo, Nan

    2016-10-01

    The time trade-off (TTO) valuation technique is widely used to determine utility values of health outcomes to inform quality-adjusted life-year (QALY) calculations for use in economic evaluation. Protocols for implementing TTO vary in aspects such as the trade-off framework, iteration procedure and its administration model and method, training of respondents and interviewers, and quality control of data collection. The most widely studied and utilized TTO valuation protocols are the Measurement and Valuation of Health (MVH) protocol, the Paris protocol and the EuroQol Valuation Technology (EQ-VT) protocol, all developed by members of the EuroQol Group. The MVH protocol and its successor, the Paris protocol, were developed for valuation of EQ-5D-3L health states. Both protocols were designed for a trained interviewer to elicit preferences from a respondent using the conventional TTO framework with a fixed time horizon of 10 years and an iteration procedure combining bisection and titration. Developed for valuation of EQ-5D-5L health states, the EQ-VT protocol adopted a composite TTO framework and made use of computer technology to facilitate data collection. Training and monitoring of interviewers and respondents is a pivotal component of the EQ-VT protocol. Research is underway aiming to further improve the EuroQol protocols, which form an important basis for the current practice of health technology assessment in many countries.

  15. Rationale and study protocol for a multi-component Health Information Technology (HIT) screening tool for depression and post-traumatic stress disorder in the primary care setting.

    PubMed

    Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V; Sorkin, Dara H

    2016-09-01

    The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients' mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers' time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression and other mental health disorders in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients' primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder (PTSD) among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting. PMID:27394385

  16. Examining the ethical and social issues of health technology design through the public appraisal of prospective scenarios: a study protocol describing a multimedia-based deliberative method

    PubMed Central

    2014-01-01

    Background The design of health technologies relies on assumptions that affect how they will be implemented, such as intended use, complexity, impact on user autonomy, and appropriateness. Those who design and implement technologies make several ethical and social assumptions on behalf of users and society more broadly, but there are very few tools to examine prospectively whether such assumptions are warranted and how the public define and appraise the desirability of health innovations. This study protocol describes a three-year study that relies on a multimedia-based prospective method to support public deliberations that will enable a critical examination of the social and ethical issues of health technology design. Methods The first two steps of our mixed-method study were completed: relying on a literature review and the support of our multidisciplinary expert committee, we developed scenarios depicting social and technical changes that could unfold in three thematic areas within a 25-year timeframe; and for each thematic area, we created video clips to illustrate prospective technologies and short stories to describe their associated dilemmas. Using this multimedia material, we will: conduct four face-to-face deliberative workshops with members of the public (n = 40) who will later join additional participants (n = 25) through an asynchronous online forum; and analyze and integrate three data sources: observation, group deliberations, and a self-administered participant survey. Discussion This study protocol will be of interest to those who design and assess public involvement initiatives and to those who examine the implementation of health innovations. Our premise is that using user-friendly tools in a deliberative context that foster participants’ creativity and reflexivity in pondering potential technoscientific futures will enable our team to analyze a range of normative claims, including some that may prove problematic and others that may

  17. Health Systems Readiness to Manage the Hypertension Epidemic in Primary Health Care Facilities in the Western Cape, South Africa: A Study Protocol

    PubMed Central

    Yaya, Sanni; Labonté, Ronald

    2016-01-01

    Background Developing countries are undergoing a process of epidemiological transition from infectious to noncommunicable diseases, described by the United Nations Secretary General Ban Ki-Moon as ‘‘a public health emergency in slow motion.” One of the most prevalent in sub-Saharan Africa is hypertension, which is a complex chronic condition often referred to as a “silent killer” and key contributor to the development of cardiovascular and cerebrovascular diseases. Hypertensive patients in this setting are estimated to increase from 74.7 million in 2008 to 125.5 million in 2025, a 68% increase. However, there is an important gap between emerging high-level policies and recommendations, and the near-absence of practical guidance and experience delivering long-term medical care for noncommunicable diseases within resource-limited health systems. Objective To address this gap, our study will consist of field investigations to determine the minimum health systems requirements to ensure successful delivery of antihypertensive medications when scaling-up interventions to control the hypertension epidemic. Methods A cross-sectional analytic study will be conducted in the Western Cape using a mixed-method approach with two semistructured interview guides. The first will be for health professionals involved in the care of hypertensive patients within at least 6 community health centers (3 urban and 3 rural) to understand the challenges associated with their care. The second will be to map and assess the current supply chain management system of antihypertensive medications by interviewing key informants at different levels of the processes. Finally, modeling and simulation tools will be used to understand how to estimate minimum numbers of health workers required at each supply chain interval to ensure successful delivery of medications when scaling-up interventions. Results Funding for the study was secured through a Doctoral Research Award in October 2014 from

  18. Randomised controlled trial of an in-home monitoring intervention to improve health outcomes for type 2 diabetes: study protocol.

    PubMed

    Carlisle, Karen; Warren, Robin; Scuffham, Paul; Cheffins, Tracy

    2012-01-01

    Type 2 diabetes is a leading cause of death and morbidity and is a health priority in Australia. This randomised controlled trial will explore whether remote access to clinical care, supported by telehealth technologies over high speed broadband, leads to improved diabetes control in a way that benefits patients, carers and clinicians and improves the overall health system. People in the intervention arm of the trial will receive additional diabetes care from a care coordinator nurse via an in-home broadband communication device that can capture clinical measures, provide regular health assessments and videoconference with other health professionals when required. Patients in the control arm of the trial will receive usual care from their GP and participate in the clinical measurement and quality of life components of the evaluation. The trial evaluation will include biomedical, psychological, self-management and quality of life measures. Data on utilisation rates and satisfaction with the technology will be collected and cost -effectiveness analyses undertaken. The role of this technology in health care reform will be explored. PMID:23138078

  19. Body composition and bone health in long-term survivors of acute lymphoblastic leukaemia in childhood and adolescence: the protocol for a cross-sectional cohort study

    PubMed Central

    Barr, Ronald; Nayiager, Trishana; Gordon, Christopher; Marriott, Christopher; Athale, Uma

    2015-01-01

    Introduction Success in the treatment of young people with cancer, as measured conventionally by survival rates, is mitigated by late effects of therapy that impose a burden of morbidity and limit life expectancy. Among these adverse sequelae are altered body composition, especially obesity, and compromised bone health in the form of osteoporosis and increased fragility. These outcomes are potentially reversible and even preventable. This study will examine measures of body composition and bone health in long-term survivors of acute lymphoblastic leukaemia (ALL) in childhood and adolescence. These measures will be complemented by measures of physical activity and health-related quality of life (HRQL). Methods and analysis Survivors of ALL who are at least 10 years from diagnosis, following treatment on uniform protocols, will undergo measurements of body mass index; triceps skin fold thickness and mid-upper arm circumference; fat mass, lean body mass, skeletal muscle mass and bone mineral density by dual energy X-ray absorptiometry; trabecular and cortical bone indices and muscle density by peripheral quantitative CT; physical activity by the Habitual Activity Estimation Scale; and HRQL by Health Utilities Index instruments. Descriptive measures will be used for continuous variables and number (percent) for categorical variables. Associations between variables will be assessed using Fisher's exact t test and the χ2 test; correlations will be tested by the Pearson correlation coefficient. Ethics and dissemination The study is approved by the institutional research ethics board and is supported by a competitive funding award. Dissemination of the results will occur by presentations to scientific meetings and publications in peer-reviewed journals, and by posting summaries of the results on websites accessed by adolescent and young adult survivors of cancer. PMID:25603918

  20. Effectiveness and cost-effectiveness of the Salut Programme: a universal health promotion intervention for parents and children—protocol of a register-based retrospective observational study

    PubMed Central

    Feldman, Inna; Eurenius, Eva; Häggström, Jenny; Sampaio, Filipa; Lindkvist, Marie; Pulkki-Brännström, Anni-Maria; Ivarsson, Anneli

    2016-01-01

    Introduction There is inadequate evidence for the effectiveness and cost-effectiveness of health promotion interventions. The Salut Programme aims to reach all parents and children in the Västerbotten County of Sweden with a combination of health promotion interventions initiated during pregnancy and continued over the childhood period. This study protocol describes an effectiveness study and an economic evaluation study, where the ongoing Salut Programme is compared to care-as-usual over the periods of pregnancy, delivery and the child's first 2 years of life. Methods A register-based retrospective observational study design will be used with existing data sources with respect to exposures and outcomes. Outcomes of interest are clustered at 3 points: around the child's birth, 1 month after the child's birth and 2 years after the child's birth. We will simulate an experiment by retrospectively identifying and comparing children and their parents in the geographical areas where the Salut Programme was implemented since 2006 and onwards, and the areas where the Programme was not implemented before 2009. Outcomes will be analysed and compared for the premeasure period, and the postmeasure period for both groups. Our analysis combines difference-in-difference estimation with matching. A complementary analysis will be carried out on the longitudinal subsample of mothers who gave birth at least once during each of the time periods. The economic evaluation aims to capture the wider societal costs and benefits of the Salut Programme for the first 2 years of the children's lives. Incremental costs will be compared with incremental health gains and the results will be presented as a cost-consequence analysis. Ethics and dissemination The Regional Ethical Review Board in Umeå has given clearance for the Salut Programme research (2010-63-31M). No individual's identity will be revealed when presenting results. This study will provide information that can guide

  1. Using an eHealth Intervention to Stimulate Health Behavior for the Prevention of Cognitive Decline in Dutch Adults: A Study Protocol for the Brain Aging Monitor

    PubMed Central

    2015-01-01

    Background Internet-delivered intervention programs are an effective way of changing health behavior in an aging population. The same population has an increasing number of people with cognitive decline or cognitive impairments. Modifiable lifestyle risk factors such as physical activity, nutrition, smoking, alcohol consumption, sleep, and stress all influence the probability of developing neurodegenerative diseases such as Alzheimer’s disease. Objective This study aims to answer two questions: (1) Is the use of a self-motivated, complex eHealth intervention effective in changing multiple health behaviors related to cognitive aging in Dutch adults in the work force, especially those aged 40 and over? and (2) Does this health behavior change result in healthier cognitive aging patterns and contribute to preventing or delaying future onset of neurodegenerative syndromes? Methods The Brain Aging Monitor study uses a quasi-experimental 2-year pre-posttest design. The Brain Aging Monitor is an online, self-motivated lifestyle intervention program. Recruitment is done both in medium to large organizations and in the Dutch general population over the age of 40. The main outcome measure is the relationship between lifestyle change and cognitive aging. The program uses different strategies and modalities such as Web content, email, online newsletters, and online games to aid its users in behavior change. To build self-regulatory skills, the Brain Aging Monitor offers its users goal-setting activities, skill-building activities, and self-monitoring. Results Study results are expected to be published in early 2016. Conclusions This study will add to the body of evidence on the effectiveness of eHealth intervention programs with the combined use of state-of-the-art applied games and established behavior change techniques. This will lead to new insights on how to use behavior change techniques and theory in multidimensional lifestyle eHealth research, and how these techniques

  2. African Breast Cancer—Disparities in Outcomes (ABC-DO): protocol of a multicountry mobile health prospective study of breast cancer survival in sub-Saharan Africa

    PubMed Central

    McKenzie, Fiona; Zietsman, Annelle; Galukande, Moses; Anele, Angelica; Adisa, Charles; Cubasch, Herbert; Parham, Groesbeck; Anderson, Benjamin O; Abedi-Ardekani, Behnoush; Schuz, Joachim; dos Santos Silva, Isabel; McCormack, Valerie

    2016-01-01

    Introduction Sub-Saharan African (SSA) women with breast cancer (BC) have low survival rates from this potentially treatable disease. An understanding of context-specific societal, health-systems and woman-level barriers to BC early detection, diagnosis and treatment are needed. Methods The African Breast Cancer—Disparities in Outcomes (ABC-DO) is a prospective hospital-based study of overall survival, impact on quality of life (QOL) and delays along the journey to diagnosis and treatment of BC in SSA. ABC-DO is currently recruiting in Namibia, Nigeria, South Africa, Uganda and Zambia. Women aged 18 years or older who present at participating secondary and tertiary hospitals with a new clinical or histocytological diagnosis of primary BC are invited to participate. For consented women, tumour characteristics, specimen and treatment data are obtained. Over a 2-year enrolment period, we aim to recruit 2000 women who, in the first instance, will be followed for between 1 and 3 years. A face-to-face baseline interview obtains information on socioeconomic, cultural and demographic factors, QOL, health and BC attitudes/knowledge, and timing of all prediagnostic contacts with caregivers in orthodox health, traditional and spiritual systems. Responses are immediately captured on mobile devices that are fed into a tailored mobile health (mHealth) study management system. This system implements the study protocol, by prompting study researchers to phone women on her mobile phone every 3 months and, failing to reach her, prompts contact with her next-of-kin. At follow-up calls, women provide updated information on QOL, care received and disease impacts on family and working life; date of death is asked of her next-of-kin when relevant. Ethics and dissemination The study was approved by ethics committees of all involved institutions. All participants provide written informed consent. The findings from the study will be published in peer-reviewed scientific journals

  3. Using core sets of the international classification of functioning, disability and health (ICF) to measure disability in vestibular disorders: study protocol.

    PubMed

    Grill, Eva; Furman, Joseph M; Alghwiri, Alia A; Müller, Martin; Whitney, Susan L

    2013-01-01

    Symptom frequency and severity in vestibular disorders often do not correlate well with patients' restrictions of activities of daily living and limitations of participation. Due to the lack of appropriate patient reported outcome measures (PRO), the extent of limitations and restrictions is mostly unknown. The International Classification of Functioning, Disability and Health (ICF) is a conceptual framework and classification to evaluate all aspects of health and disability. An ICF-based measure, the Vestibular and Participation Measure (VAP), was recently proposed. Also, an ICF Core Set for vertigo, dizziness and balance disorders was developed to describe what aspects of functioning should be measured. This study protocol describes the development and cross-cultural validation of a new measure, the VAP-extended (VAP-e), based on VAP and ICF Core Set on three continents. To determine objectivity and cross-cultural validity of the VAP and to find potentially redundant items, Rasch models will be used. The VAP-e will be created by modifying or adding items from the Activities and Participation and Environmental Factors component of the ICF Core Set. Reliability, objectivity and responsiveness of the VAP-e will be tested.

  4. Supporting collaborative use of the diabetes population risk tool (DPoRT) in health-related practice: a multiple case study research protocol

    PubMed Central

    2014-01-01

    Background Health policy makers have stated that diabetes prevention is a priority; however, the type, intensity, and target of interventions or policy changes that will achieve the greatest impact remains uncertain. In response to this uncertainty, the Diabetes Population Risk Tool (DPoRT) was developed and validated to estimate future diabetes risk based on routinely collected population data. To facilitate use of DPoRT, we partnered with regional and provincial health-related decision makers in Ontario and Manitoba, Canada. Primary objectives include: i) evaluate the effectiveness of partnerships between the research team and DPoRT users; ii) explore strategies that facilitate uptake and overcome barriers to DPoRT use; and iii) implement and evaluate the knowledge translation approach. Methods This protocol reflects an integrated knowledge translation (IKT) approach and corresponds to the action phase of the Knowledge-to-Action (KtoA) framework. Our IKT approach includes: employing a knowledge brokering team to facilitate relationships with DPoRT users (objective 1); tailored training for DPoRT users; assessment of barriers and facilitators to DPoRT use; and customized dissemination strategies to present DPoRT outputs to decision maker audiences (objective 2). Finally, a utilization-focused evaluation will assess the effectiveness and impact of the proposed KtoA process for DPoRT application (objective 3). This research design utilizes a multiple case study approach. Units of analyses consist of two public health units, one provincial health organization, and one provincial knowledge dissemination team whereby we will connect with multiple regional health authorities. Evaluation will be based on analysis of both quantitative and qualitative data collected from passive (e.g., observer notes) and active (e.g., surveys and interviews) methods. Discussion DPoRT offers an innovative way to make routinely collected population health data practical and meaningful for

  5. Ecological assessment of the direct and indirect effects of routine rotavirus vaccination in Merseyside, UK using data from multiple health systems: a study protocol

    PubMed Central

    Hungerford, Daniel; Vivancos, Roberto; French, Neil; Iturriza-Gomara, Miren; Cunliffe, Nigel

    2014-01-01

    Introduction Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide. Currently 67 countries include rotavirus vaccine in childhood immunisation programmes, but uptake in Western Europe has been slow. In July 2013, rotavirus vaccine was introduced into the UK's routine childhood immunisation programme. Prior to vaccine introduction in the UK, rotavirus was estimated to result in 750 000 diarrhoea episodes and 80 000 general practice (GP) consultations each year, together with 45% and 20% of hospital admissions and emergency department attendances for acute gastroenteritis, in children under 5 years of age. This paper describes a protocol for an ecological study that will assess rotavirus vaccine impact in the UK, to inform rotavirus immunisation policy in the UK and in other Western European countries. Methods and analysis In Merseyside, UK, we will conduct an ecological study using a ‘before and after’ approach to examine changes in gastroenteritis and rotavirus incidence following the introduction of rotavirus vaccination. Data will be collected on mortality, hospital admissions, nosocomial infection, emergency department attendances, GP consultations and community health consultations to capture all healthcare providers in the region. We will assess both the direct and indirect effects of the vaccine on the study population. Comparisons of outcome indicator rates will be made in relation to vaccine uptake and socioeconomic status. Ethics and dissemination The study has been approved by NHS Research Ethics Committee, South Central-Berkshire REC Reference: 14/SC/1140. Study outputs will be disseminated through scientific conferences and peer-reviewed publications. The study will demonstrate the impact of rotavirus vaccination on the burden of disease from a complete health system perspective. It will identify key areas that require improved data collection tools to maximise the usefulness of this surveillance

  6. Partners for the optimal organisation of the healthcare continuum for high users of health and social services: protocol of a developmental evaluation case study design

    PubMed Central

    Hudon, Catherine; Chouinard, Maud-Christine; Couture, Martine; Brousselle, Astrid; Couture, Eva Marjorie; Dubois, Marie-France; Fortin, Martin; Freund, Tobias; Loignon, Christine; Mireault, Jean; Pluye, Pierre; Roberge, Pasquale; Rodriguez, Charo

    2014-01-01

    Introduction Case management allows us to respond to the complex needs of a vulnerable clientele through a structured approach that promotes enhanced interaction between partners. Syntheses on the subject converge towards a need for a better description of the relationships between programmes and their local context, as well as the characteristics of the clienteles and programmes that contribute to positive impacts. The purpose of this project is thus to describe and evaluate the case management programmes of four health and social services centres in the Saguenay-Lac- Saint-Jean region of Québec, Canada, in order to inform their improvement while creating knowledge on case management that can be useful in other contexts. Methods and analysis This research relies on a multiple embedded case study design based on a developmental evaluation approach. We will work with the case management programme for high users of hospital services of each centre. Three different units of analysis will be interwoven to obtain an in-depth understanding of each case, that is: (1) health and social services centre and local services network, (2) case management programme and (3) patients who are high users of services. Two strategies for programme evaluation (logic models and implementation analysis) will guide the mixed data collection based on qualitative and quantitative methods. This data collection will rely on: (1) individual interviews and focus groups; (2) participant observation; (3) document analysis; (4) clinical and administrative data and (5) questionnaires. Description and comparison of cases, and integration of qualitative and quantitative data will be used to guide the data analysis. Ethics and dissemination The study protocol was approved by the Ethics Research Boards of the four health and social services centres (HSSCs) involved. Findings will be disseminated by publications in peer-reviewed journals, conferences, and policy and practice partners in local and

  7. Estimated cost of a health visitor-led protocol for perinatal mental health.

    PubMed

    Oluboyede, Yemi; Lewis, Anne; Ilott, Irene; Lekka, Chrysanthi

    2010-06-01

    Anecdotally, protocols, care pathways and clinical guidelines are time consuming to develop and sustain, but there is little research about the actual costs of their development, use and audit.This is a notable gap considering the pervasiveness of such documents that are intended to reduce unacceptable variations in practice by standardising care processes. A case study research design was used to calculate the resource use costs of a protocol for perinatal mental health, part of the core programme for health visitors in a primary care trust in the west of England. The methods were in-depth interviews with the operational lead for the protocol (a health visitor) and documentary analysis. The total estimated cost of staff time over a five-year period (2004 to 2008) was Euro 73,598, comprising Euro 36,162 (49%) for development and Euro 37,436 (51%) for implementation. Although these are best estimates dependent upon retrospective data, they indicate the opportunity cost of staff time for a single protocol in one trust over five years. When new protocols, care pathways or clinical guidelines are proposed, the costs need to be considered and weighed against the benefits of engaging frontline staff in service improvements. PMID:20586374

  8. Using Tablet Computers to Increase Patient Engagement With Electronic Personal Health Records: Protocol For a Prospective, Randomized Interventional Study

    PubMed Central

    Magan Mendoza, Yimdriuska; Rosenthal, Jaime; Jacolbia, Ronald; Rajkomar, Alvin; Lee, Herman; Auerbach, Andrew

    2016-01-01

    Background Inadequate patient engagement in care is a major barrier to successful transitions from the inpatient setting and can lead to preventable adverse events after discharge, particularly for older adults. While older adults may be less familiar with mobile devices and applications, they may benefit from focused bedside training to engage them in using their Personal Health Record (PHR). Mobile technologies such as tablet computers can be used in the hospital to help bridge this gap in experience by teaching older, hospitalized patients to actively manage their medication list through their PHR during hospitalization and continue to use their PHR for other post-discharge tasks such as scheduling follow-up appointments, viewing test results, and communicating with providers. Bridging this gap is especially important for older, hospitalized adults as they are at higher risk than younger populations for low engagement in transitions of care and poor outcomes such as readmission. Greater understanding of the advantages and limitations of mobile devices for older adults may be important for improving transitions of care. Objective To better understand the effective use of mobile technologies to improve transitions in care for hospitalized, older adults and leverage these technologies to improve inpatient and postdischarge care for older adults. Methods We will compare an intervention group with tablet-based training to engage effectively with their PHR to a control group also receiving tablets and basic access to their PHR but no additional training on how to engage with their PHR. Results Patient enrollment is ongoing. Conclusions Through this grant, we will further develop our preliminary dataset and practical experience with these mobile technologies to catalyze patient engagement during hospitalization. ClinicalTrial ClinicalTrials.gov NCT02109601; https://clinicaltrials.gov/ct2/show/NCT02109601 (Archived by WebCite at http://www.webcitation.org/6jpXjkwM8

  9. Does Interpersonal Psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? Study protocol for a cluster randomised feasibility trial

    PubMed Central

    Bearsley-Smith, Cate; Browne, Mark Oakley; Sellick, Ken; Villanueva, Elmer V; Chesters, Janice; Francis, Karen; Reddy, Prasuna

    2007-01-01

    coefficient will be calculated and used to inform sample size calculations for subsequent large-scale trials. Qualitative data regarding process implementation will be collected quarterly from focus groups with participating clinicians over 18 months, plus phone interviews with participating adolescents and parent/guardians at 12 weeks and 24 weeks of treatment. The focus group qualitative data will be analysed using a Fourth Generation Evaluation methodology that includes a constant comparative cyclic analysis method. Discussion This study protocol will be informative for researchers and clinicians interested in considering, designing and/or conducting cluster randomised trials within community practice such as mental health services. Trial Registration Australian Clinical Trials Registry ACTRNO12607000324415 PMID:17915032

  10. Improving the quality of perinatal mental health: a health visitor-led protocol.

    PubMed

    Lewis, Anne; Ilot, Irene; Lekka, Chrysanthi; Oluboyede, Yemi

    2011-02-01

    The mental health of mothers is of significant concern to community practitioners. This paper reports on a case study exploring the success factors of a well established, health visitor-led protocol to identify and treat women with mild to moderate depression. Data were collected through interviews with a purposive sample of 12 community practitioners, a focus group of four health visitors and observation of a multidisciplinary steering group meeting. The protocol was described as an evidence-based tool and safety net that could be used flexibly to support clinical judgments and tailored to individual needs. Success factors included frontline clinician engagement and ownership, continuity of leadership to drive development and maintain momentum, comprehensive and on-going staff training, and strategic support for the protocol as a quality indicator at a time of organisational change. Quality and clinical leadership are continuing policy priorities. The protocol enabled frontline staff to lead a service innovation, providing a standardised multiprofessional approach to women's mental health needs through effective support, advice and treatment that can be measured and quality assured. PMID:21388041

  11. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background With increasing age neuromuscular deficits (e.g., sarcopenia) may result in impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk factors are age-related decreases in balance and strength / power performance as well as cognitive decline. Additional studies are needed to develop specifically tailored exercise programs for older adults that can easily be implemented into clinical practice. Thus, the objective of the present trial is to assess the effects of a fall prevention program that was developed by an interdisciplinary expert panel on measures of balance, strength / power, body composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older adults. Additionally, the time-related effects of detraining are tested. Methods/Design Healthy old people (n = 54) between the age of 65 to 80 years will participate in this trial. The testing protocol comprises tests for the assessment of static / dynamic steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e., perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test; countermovement jump). Further, body composition will be analysed using a bioelectrical impedance analysis system. In addition, questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk determinants (i.e., Fall Efficacy Scale – International) will be included in the study protocol. Participants will be randomized into two intervention groups or the control / waiting group. After baseline measures, participants in the intervention groups will conduct a 12-week balance and strength / power exercise intervention 3 times per week, with

  12. Prevalence, Motivations, and Social, Mental Health and Health Consequences of Cyberbullying Among School-Aged Children and Youth: Protocol of a Longitudinal and Multi-Perspective Mixed Method Study

    PubMed Central

    McInroy, Lauren B; Lacombe-Duncan, Ashley; Bhole, Payal; Van Wert, Melissa; Schwan, Kaitlin; Birze, Arija; Daciuk, Joanne; Beran, Tanya; Craig, Wendy; Pepler, Debra J; Wiener, Judith; Khoury-Kassabri, Mona; Johnston, David

    2016-01-01

    Background While the online environment may promote important developmental and social benefits, it also enables the serious and rapidly growing issue of cyberbullying. Cyberbullying constitutes an increasing public health problem – victimized children and youth experience a range of health and mental health concerns, including emotional and psychosomatic problems, maladaptive behaviors, and increased suicidality. Perpetrators demonstrate a lack of empathy, and may also struggle with health and mental health issues. Objective This paper describes the protocols applied in a longitudinal and multi-perspective mixed-methods study with five objectives: (1) to explore children/youth’s experiences, and children/youth’s, parents’, and teachers’ conceptions, definitions, and understanding of cyberbullying; (2) to explore how children/youth view the underlying motivations for cyberbullying; (3) to document the shifting prevalence rates of cyberbullying victimization, witnessing, and perpetration; (4) to identify risk and protective factors for cyberbullying involvement; and (5) to explore social, mental health, and health consequences of cyberbullying. Methods Quantitative survey data were collected over three years (2012-2014) from a stratified random baseline sample of fourth (n=160), seventh (n=243), and tenth (n=267) grade children/youth, their parents (n=246), and their teachers (n=103). Quantitative data were collected from students and teachers during in-person school visits, and from parents via mail-in surveys. Student, parent, and teacher surveys included questions regarding: student experiences with bullying/cyberbullying; student health, mental health, and social and behavioral issues; socio-demographics; and information and communication technology use. In-depth semi-structured qualitative interviews were conducted twice with a sub-sample of students (n=57), purposively selected based on socio-demographics and cyberbullying experience, twice with

  13. Oral health protocol for the dependent institutionalized elderly.

    PubMed

    Gil-Montoya, Jose Antonio; de Mello, Ana Lucia Ferreira; Cardenas, Ciro Barreto; Lopez, Inmaculada Guardia

    2006-01-01

    Establishing an oral hygiene protocol for the frail and functionally dependent elderly should be of special concern to health care providers. The previous assessment of a care center, including patients or residents and staff, allows an effective strategy to be designed. Oral health protocols are mainly based on the daily removal of bacterial plaque from teeth or prostheses (or both), cleaning of oral mucosa, and continual oral hydration. These practices are facilitated by the use of electric toothbrushes and products such as chlorhexidine, fluoride toothpastes, and rinses or gels for dry mouth. This type of protocol should include regular collaboration with dental professionals and provide a program of continuous training for nursing staff on oral health issues.

  14. Using patients’ experiences of adverse events to improve health service delivery and practice: protocol of a data linkage study of Australian adults age 45 and above

    PubMed Central

    Walton, Merrilyn; Smith-Merry, Jennifer; Harrison, Reema; Manias, Elizabeth; Iedema, Rick; Kelly, Patrick

    2014-01-01

    Introduction Evidence of patients’ experiences is fundamental to creating effective health policy and service responses, yet is missing from our knowledge of adverse events. This protocol describes explorative research redressing this significant deficit; investigating the experiences of a large cohort of recently hospitalised patients aged 45 years and above in hospitals in New South Wales (NSW), Australia. Methods and analysis The 45 and Up Study is a cohort of 265 000 adults aged 45 years and above in NSW. Patients who were hospitalised between 1 January and 30 June 2014 will be identified from this cohort using data linkage and a random sample of 20 000 invited to participate. A cross-sectional survey (including qualitative and quantitative components) will capture patients’ experiences in hospital and specifically of adverse events. Approximately 25% of respondents are likely to report experiencing an adverse event. Quantitative components will capture the nature and type of events as well as common features of patients’ experiences. Qualitative data provide contextual knowledge of their condition and care and the impact of the event on individuals. Respondents who do not report an adverse event will report their experience in hospital and be the control group. Statistical and thematic analysis will be used to present a patient perspective of their experiences in hospital; the characteristics of patients experiencing an adverse event; experiences of information sharing after an event (open disclosure) and the other avenues of redress pursued. Interviews with key policymakers and a document analysis will be used to create a map of the current practice. Ethics and dissemination Dissemination via a one-day workshop, peer-reviewed publications and conference presentations will enable effective clinical responses and service provision and policy responses to adverse events to be developed. PMID:25311039

  15. The iMpact on practice, oUtcomes and costs of New roles for health pROfeSsionals: a study protocol for MUNROS

    PubMed Central

    Bond, Christine; Bruhn, Hanne; de Bont, Antoinette; van Exel, Job; Busse, Reinhard; Sutton, Matthew; Elliott, Robert

    2016-01-01

    Introduction The size and composition of the European Union healthcare workforce are key drivers of expenditure and performance; it now includes new health professions and enhanced roles for established professions. This project will systematically analyse how this has contributed to health service redesign, integration and performance in 9 European countries (Scotland, England, Netherlands, Germany, Italy, Czech Republic, Poland, Norway, and Turkeyi). This paper describes the protocol for collection of survey data in 3 distinct care pathways, and sets it in the context of the wider programme. Methods Questionnaires will be distributed to healthcare professionals (n=14 580), managers (n=3564) and patients (n=19 440) in 3 care pathways (breast cancer; type 2 diabetes; and coronary heart disease) within 12 hospitals and associated primary care settings in each country. Questionnaire topics will include demography, the different professionals working on the care pathway, the tasks they do and the time taken, their decision-making abilities when considering skill mix, specialisation and integration of care. Patient satisfaction, healthcare utilisation and preferences will be explored. In later work, register data and data from patient records will be used to record clinical outcomes. Data will also be collected on workforce and procedure costs. Descriptive analysis will identify the different models of care and multivariate analysis will establish the most clinically and cost-effective models. Ethics and dissemination This protocol was approved by ethical committees in each country. Findings will be disseminated through national/international clinical, health services research and health workforce conferences, and publications in national/international peer-reviewed journals. PMID:27118286

  16. Cohort study on clustering of lifestyle risk factors and understanding its association with stress on health and wellbeing among school teachers in Malaysia (CLUSTer) – a study protocol

    PubMed Central

    2014-01-01

    Background The study on Clustering of Lifestyle risk factors and Understanding its association with Stress on health and wellbeing among school Teachers in Malaysia (CLUSTer) is a prospective cohort study which aims to extensively study teachers in Malaysia with respect to clustering of lifestyle risk factors and stress, and subsequently, to follow-up the population for important health outcomes. Method/design This study is being conducted in six states within Peninsular Malaysia. From each state, schools from each district are randomly selected and invited to participate in the study. Once the schools agree to participate, all teachers who fulfilled the inclusion criteria are invited to participate. Data collection includes a questionnaire survey and health assessment. Information collected in the questionnaire includes socio-demographic characteristics, participants’ medical history and family history of chronic diseases, teaching characteristics and burden, questions on smoking, alcohol consumption and physical activities (IPAQ); a food frequency questionnaire, the job content questionnaire (JCQ); depression, anxiety and stress scale (DASS21); health related quality of life (SF12-V2); Voice Handicap Index 10 on voice disorder, questions on chronic pain, sleep duration and obstetric history for female participants. Following blood drawn for predefined clinical tests, additional blood and urine specimens are collected and stored for future analysis. Active follow up of exposure and health outcomes will be carried out every two years via telephone or face to face contact. Data collection started in March 2013 and as of the end of March 2014 has been completed for four states: Kuala Lumpur, Selangor, Melaka and Penang. Approximately 6580 participants have been recruited. The first round of data collection and blood sampling is expected to be completed by the end of 2014 with an expected 10,000 participants recruited. Discussion Our study will provide a good basis

  17. Evaluating the impact of depression, anxiety & autonomic function on health related quality of life, vocational functioning and health care utilisation in acute coronary syndrome patients: the ADVENT study protocol

    PubMed Central

    2013-01-01

    Background Depression and anxiety are highly prevalent and co-morbid in acute coronary syndrome patients. Somatic and cognitive subtypes of depression and anxiety in acute coronary syndrome have been shown to be associated with mortality although their association with patient outcomes is unknown, as are the mechanisms that underpin these associations. We are conducting a prospective cohort study which aims to examine in acute coronary syndrome patients: (1) the role of somatic subtypes of depression and anxiety as predictors of health related quality of life outcomes; (2) how somatic subtypes of depression and anxiety relate to long term vocational functioning and healthcare utilisation; and (3) the role of the autonomic nervous system assessed by heart rate variability as a moderator of these associations. Methods Patients are being screened after index admission for acute coronary syndrome at a single, high volume centre, MonashHeart, Monash Health, Victoria, Australia. The inclusion criterion is all patients aged > 21 years old and fluent in English admitted to MonashHeart, Monash Health with a diagnosis of acute coronary syndrome. The primary outcome is mean health related quality of life (Short Form-36) Physical and Mental Health Summary scores at 12 and 24 months in subtypes with somatic symptoms of depression and anxiety. Depressive domains are assessed by the Beck Depression Inventory II and the Cardiac Depression Scale. Anxiety is measured using the Speilberger State-Trait Anxiety Inventory and the Crown Crisp Phobic Anxiety questionnaire. Secondary outcomes include clinical variables, healthcare service utilisation and vocational functioning. Discussion This manuscript presents the protocol for a prospective cohort study which will investigate the role of somatic subtypes of depression and anxiety as predictors of health related quality of life, long-term vocational functioning and health service use, and the role of the autonomic nervous system in

  18. A longitudinal study of the impact of chronic psychological stress on health-related quality of life and clinical biomarkers: protocol for the Australian Healthy Aging of Women Study

    PubMed Central

    2014-01-01

    Background Despite advancements in our understanding of the importance of stress reduction in achieving good health, we still only have limited insight into the impact of stress on cellular function. Recent studies have suggested that exposure to prolonged psychological stress may alter an individual’s physiological responses, and contribute to morbidity and mortality. This paper presents an overview of the study protocol we are using to examine the impact of life stressors on lifestyle factors, health-related quality of life and novel and established biomarkers of stress in midlife and older Australian women. The primary aim of this study is to explore the links between chronic psychological stress on both subjective and objective health markers in midlife and older Australian women. The study examines the extent to which exposure frightening, upsetting or stressful events such as natural disasters, illness or death of a relative, miscarriage and relationship conflict is correlated with a variety of objective and subjective health markers. Methods/Design This study is embedded within the longitudinal Healthy Aging of Women’s study which has collected data from midlife and older Australian women at 5 yearly intervals since 2001, and uses the Allostastic model of women’s health by Groër and colleagues in 2010. The current study expands the focus of the HOW study and will assess the impact of life stressors on quality of life and clinical biomarkers in midlife and older Australian women to explain the impact of chronic psychological stress in women. Discussion The proposed study hypothesizes that women are at increased risk of exposure to multiple or repeated stressors, some being unique to women, and the frequency and chronicity of stressors increases women’s risk of adverse health outcomes. This study aims to further our understanding of the relationships between stressful life experiences, perceived quality of life, stress biomarkers, chronic illness, and

  19. The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of dementia screening (CHOICE) study: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Dementia affects over 4 million people in the US and is frequently unrecognized and underdiagnosed in primary care. Routine dementia screening in primary care is not recommended by the US Preventive Services Task Force due to lack of empirical data on the benefits and harms of screening. This trial seeks to fill this gap and contribute information about the benefits, harms, and costs of routine screening for dementia in primary care. Methods/Design Single-blinded, parallel, randomized controlled clinical trial with 1:1 allocation. A total of 4,000 individuals aged ≥65 years without a diagnosis of dementia, cognitive impairment, or serious mental illness receiving care at primary care practices within two cities in Indiana. Subjects will be randomized to either i) screening for dementia using the Memory Impairment Screen Telephone version or ii) no screening for dementia. Subjects who screen positive for dementia will be referred to the local Aging Brain Care program that delivers an evidence-based collaborative care model for dementia and depression. Research assistants will administer the 15-item Health Utility Index, Patient Health Questionnaire, Generalized Anxiety Disorder Scale, and Medical Outcomes Study at baseline, 1, 6, and 12 months. Information about advanced care planning will be collected at baseline and 12 months. All enrollees’ medical records will be reviewed to collect data on health care utilization and costs. Discussion We have two primary hypotheses; first, in comparison to non-screened subjects, those who are screened and referred to a dementia collaborative care program will have a higher health-related quality of life as measured by the Health Utility Index at 12 months post-screening. Second, in comparison to non-screened subjects, those who are screened and referred to a dementia collaborative care program will not have higher depression or anxiety at one month post-screening as measured by the Patient Health

  20. Observational study on factors related to health-promoting community activity development in primary care (frAC Project): a study protocol

    PubMed Central

    Ripoll, Joana; Ruiz-Giménez, Juan Luís; Montaner Gomis, Isabel; Benedé Azagra, Carmen Belén; Elizalde Soto, Lázaro; Vidal, Mª Clara; Bauzà Amengual, M de Lluc; Planas Juan, Trinidad; Maria Pérez Mariano, Damiana; Llull Sarralde, Micaela; Bajo Viñas, Rosa; Jordan Martin, Matilde; Solano Villarubia, Carmen; Rodriguez Bajo, Maria; Cordoba Victoria, Manuela; Badia Capdevila, Marta; Serrano Ferrandez, Elena; Bosom Diumenjo, Maria; Zabaleta del Olmo, Nieves; Bolívar-Ribas, Bonaventura; Antoñanzas Lombarte, Angel; Bregel Cotaina, Samantha; Calvo Tocado, Ana; Olivan Blázquez, Barbara; Magallón Botaya, Rosa; Marín Palacios, Pilar; Echauri Ozcoidi, Margarita; Perez-Jarauta, Mª Jose; Ramos, Maria

    2012-01-01

    Introduction According to Spanish health regulations, primary care professionals have the responsibility to carry out health-promoting community activities (CAs). However, in practice, their implementation is not as widespread as it should be. The aims of this study were to identify factors within the team, the community and the professionals that influence the development of these activities and to describe the community interventions in progress. Methods and analysis This study is an observational analytical retrospective study. The information will be collected from five Spanish regions: Catalonia, Madrid, the Balearic Islands, Navarra and Aragón. The authors will contact primary care teams (PCTs) and identify the CAs from the previous year. The research team will conduct a peer review whether the inclusion criteria are met. In the health centres where CAs are implemented, the authors will select professionals carrying them out and randomly select an identical number of professionals not doing these activities. In the centres where no CA is implemented, three professionals will be randomly selected. The selected professionals will complete the questionnaires for individual-level variables. Information about the registered population and the PCTs will be collected through questionnaires and secondary sources. Outcomes Variables will be collected from the community, the PCTs, the individual professionals and CAs. Analysis A descriptive analysis of all the variables will be carried out, along with a bivariate and a logistic regression analysis, with CAs being the primary outcome. Ethics and dissemination This study has been approved by the Research Ethics Committee of the Jordi Gol y Gurina Foundation in Barcelona and area 11 in Madrid. The questionnaire distributed to the professionals will be anonymous. PMID:22586288

  1. A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes

    PubMed Central

    2010-01-01

    controlled trial. Discussion This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services. Clinical trial registration number Australian and New Zealand Clinical Trials Registry ACTRN12609000973213 PMID:21073703

  2. Protocol and baseline data from The Inala Chronic Disease Management Service evaluation study: a health services intervention study for diabetes care

    PubMed Central

    2010-01-01

    Background Type 2 Diabetes Mellitus is one of the most disabling chronic conditions worldwide, resulting in significant human, social and economic costs and placing huge demands on health care systems. The Inala Chronic Disease Management Service aims to improve the efficiency and effectiveness of care for patients with type 2 diabetes who have been referred by their general practitioner to a specialist diabetes outpatient clinic. Care is provided by a multidisciplinary, integrated team consisting of an endocrinologist, diabetes nurse educators, General Practitioner Clinical Fellows (general practitioners who have undertaken focussed post-graduate training in complex diabetes care), and allied health personnel (a dietitian, podiatrist and psychologist). Methods/Design Using a geographical control, this evaluation study tests the impact of this model of diabetes care provided by the service on patient outcomes compared to usual care provided at the specialist diabetes outpatient clinic. Data collection at baseline, 6 and 12-months will compare the primary outcome (glycaemic control) and secondary outcomes (serum lipid profile, blood pressure, physical activity, smoking status, quality of life, diabetes self-efficacy and cost-effectiveness). Discussion This model of diabetes care combines the patient focus and holistic care valued by the primary care sector with the specialised knowledge and skills of hospital diabetes care. Our study will provide empirical evidence about the clinical effectiveness of this model of care. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12608000010392. PMID:20492731

  3. Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    quality-adjusted life year gained. A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program. Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made. Discussion This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation. Trial registration Current Controlled Trials http://ISRCTN45032201 PMID:23514100

  4. STATISTICAL PRINCIPLES FOR PROSPECTIVE STUDY PROTOCOLS:

    PubMed Central

    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 are “statistically significant” or not. In the present paper we outline the considerations and suggestions on how to build a trial protocol, with an emphasis on having a rigorous protocol stage, always leading to a full article manuscript, independent of statistical findings. We conclude that authors, who find (rigorous) protocol writing too troublesome, will realize that they have already written the first half of the final paper if they follow these recommendations; authors simply need to change the protocols future tense into past tense. Thus, the aim of this clinical commentary is to describe and explain the statistical principles for trial protocols in terms of design, analysis, and reporting of findings. PMID:23091782

  5. Study to assess the effect of a structured communication approach on quality of life in secure mental health settings (Comquol): study protocol for a pilot cluster randomized trial

    PubMed Central

    2013-01-01

    Background Forensic mental health services have largely ignored examining patients’ views on the nature of the services offered to them. A structured communication approach (DIALOG) has been developed with the aim of placing the patient’s perspective on their care at the heart of the discussions between patients and clinicians. The effectiveness of the structured communication approach in community mental health services has been demonstrated, but no trial has taken place in a secure psychiatric setting. This pilot study is evaluating a 6-month intervention combining DIALOG with principles of solution-focused therapy on quality of life in medium-secure settings. Methods and design A cluster randomized controlled trial design is being employed to conduct a 36-month pilot study. Participants are recruited from six medium-secure inpatient services, with 48 patients in the intervention group and 48 in the control group. The intervention uses a structured communication approach. It comprises six meetings between patient and nurse held monthly over a 6-month period. During each meeting, patients rate their satisfaction with a range of life and treatment domains with responses displayed on a tablet. The rating is followed by a discussion of how to improve the current situation in those domains identified by the patient. Assessments take place prior to the intervention (baseline), at 6 months (postintervention) and at 12 months (follow-up). The primary outcome is the patient’s self-reported quality of life. Discussion This study aims to (1) establish the feasibility of the trial design as the basis for determining the viability of a large full-scale trial, (2) determine the variability of the outcomes of interest (quality of life, levels of satisfaction, disturbance, ward climate and engagement with services), (3) estimate the costs of the intervention and (4) refine the intervention following the outcome of the study based upon the experiences of the nurses and

  6. Exploring eHealth Ethics and Multi-Morbidity: Protocol for an Interview and Focus Group Study of Patient and Health Care Provider Views and Experiences of Using Digital Media for Health Purposes

    PubMed Central

    Adam, Paul; Li, Linda C; McDonald, Michael; Backman, Catherine L

    2013-01-01

    Background eHealth is a broad term referring to the application of information and communication technologies in the health sector, ranging from health records to medical consultations (telemedicine) and multiple forms of health education, support, and tools. By providing increased and anytime access to information, opportunities to exchange experiences with others, and self-management support, eHealth has been heralded as transformational. It has the potential to accelerate the shift from traditional "passive patient" to an informed, engaged, and empowered "patient as partner," equipped to take part in shared decision-making, and take personal responsibility for self-managing their illness. Objective The objective of our study is to examine how people with chronic illness use eHealth in their daily lives, how it affects patient-provider relationships, and the ethical and practical ramifications for patients, providers, and service delivery. Methods This two-phase qualitative study is ongoing. We will purposively sample 60-70 participants in British Columbia, Canada. To be eligible, patient participants have to have arthritis and at least one other chronic health condition; health care providers (HCPs) need a caseload of patients with multi-morbidity (>25%). To date we have recruited 36 participants (18 patients, 18 HCPs). The participants attended 7 focus groups (FGs), 4 with patients and 3 with rehabilitation professionals and physicians. We interviewed 4 HCPs who were unable to attend a FG. In phase 2, we will build on FG findings and conduct 20-24 interviews with equal numbers of patients and HCPs (rehabilitation professionals and physicians). As in the FGs conducted in phase I, the interviews will use a semistructured, but flexible, discussion guide. All discussions are being audiotaped and transcribed verbatim. Constant comparisons and a narrative approach guides the analyses. A relational ethics conceptual lens is being applied to the data to identify

  7. Barriers and facilitators to patient and public engagement and recruitment to digital health interventions: protocol of a systematic review of qualitative studies

    PubMed Central

    Hanlon, Peter; O'Donnell, Catherine A; Garcia, Sonia; Glanville, Julie; Mair, Frances S

    2016-01-01

    Introduction Patients and the public are beginning to use digital health tools to assist in managing chronic illness, support independent living and self-care, and remain connected to health and care providers. However, engaging with and enrolling in digital health interventions, such as telehealth systems, mobile health applications, patient portals and personal health records, in order to use them varies considerably. Many factors affect people's ability to engage with and sign up to digital health platforms. Objectives The primary aim is to identify the barriers and facilitators patients and the public experience to engagement and recruitment to digital health interventions. The secondary aim is to identify engagement and enrolment strategies, leading if possible to a taxonomy of such approaches, and a conceptual framework of digital health engagement and recruitment processes. Methods A systematic review of qualitative studies will be conducted by searching six databases: MEDLINE, CINAHL, PubMed, EMBASE, Scopus and the ACM Digital Library for papers published between 2000 and 2015. Titles and abstracts along with full-text papers will be screened by two independent reviewers against predetermined inclusion and exclusion criteria. A data extraction form will be used to provide details of the included studies. Quality assessment will be conducted using the Consolidated Criteria for Reporting Qualitative Research checklist. Any disagreements will be resolved through discussion with an independent third reviewer. Analysis will be guided by framework synthesis and informed by normalization process theory and burden of treatment theory, to aid conceptualisation of digital health engagement and recruitment processes. Discussion This systematic review of qualitative studies will explore factors affecting engagement and enrolment in digital health interventions. It will advance our understanding of readiness for digital health by examining the complex factors that

  8. Evaluating Computer-Tutors: A Protocol Study.

    ERIC Educational Resources Information Center

    Strickland, James

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

  9. Study protocol: the Whitehall II imaging sub-study

    PubMed Central

    2014-01-01

    Background The Whitehall II (WHII) study of British civil servants provides a unique source of longitudinal data to investigate key factors hypothesized to affect brain health and cognitive ageing. This paper introduces the multi-modal magnetic resonance imaging (MRI) protocol and cognitive assessment designed to investigate brain health in a random sample of 800 members of the WHII study. Methods/design A total of 6035 civil servants participated in the WHII Phase 11 clinical examination in 2012–2013. A random sample of these participants was included in a sub-study comprising an MRI brain scan, a detailed clinical and cognitive assessment, and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures. Data collection for this sub-study started in 2012 and will be completed by 2016. The participants, for whom social and health records have been collected since 1985, were between 60–85 years of age at the time the MRI study started. Here, we describe the pre-specified clinical and cognitive assessment protocols, the state-of-the-art MRI sequences and latest pipelines for analyses of this sub-study. Discussion The integration of cutting-edge MRI techniques, clinical and cognitive tests in combination with retrospective data on social, behavioural and biological variables during the preceding 25 years from a well-established longitudinal epidemiological study (WHII cohort) will provide a unique opportunity to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes. PMID:24885374

  10. Impact of an SMS advice programme on maternal and newborn health in rural China: study protocol for a quasi-randomised controlled trial

    PubMed Central

    Su, Yanfang; Yuan, Changzheng; Zhou, Zhongliang; Heitner, Jesse; Campbell, Benjamin

    2016-01-01

    Introduction Expectant mothers in low-income and middle-income countries often lack access to vital information about pregnancy, preparation for birth and best practices when caring for their newborn. Innovative solutions are needed to bridge this knowledge gap and dramatically improve maternal and neonatal health in these settings. This study aims to evaluate the impact of an innovative text messaging intervention on maternal and neonatal health outcomes. Methods and analysis This study offers expectant mothers in rural China a package of free short messages via cell phone regarding pregnancy and childbirth. These messages are tailored to each mother's gestational week. It is hypothesised that delivering these short advice messages to pregnant women can improve maternal and newborn health. The study uses factorial quasi-randomisation to compare psychological, behavioural and health outcomes between 4 groups: 2 groups receiving different sets of short message interventions (ie, good household prenatal practices and healthcare seeking), a group receiving both interventions and a control group. Treatment assignment occurs at the individual level. The primary outcome is newborn health, measured by appropriateness of weight for gestational age. Secondary outcomes include severe neonatal and maternal morbidity as well as psychological and behavioural measures. This study has enrolled pregnant women who attend county maternal and child health centres for their prenatal visits. Discussion This pilot is the first large-scale effort to build a comprehensive evidence base on the impact of prenatal text messages via cell phone on maternal and newborn health outcomes in China. The study has broad implications for public health policy in China and the implementation of mobile health interventions in low-resource settings around the world. Ethics This study was approved by the Ethics Committee of the School of Medicine at Xi'an Jiaotong University on 18 January 2013. Trial

  11. Impact assessment and cost-effectiveness of m-health application used by community health workers for maternal, newborn and child health care services in rural Uttar Pradesh, India: a study protocol

    PubMed Central

    Prinja, Shankar; Nimesh, Ruby; Gupta, Aditi; Bahuguna, Pankaj; Thakur, Jarnail Singh; Gupta, Madhu; Singh, Tarundeep

    2016-01-01

    Background An m-health application has been developed and implemented with community health workers to improve their counseling in a rural area of India. The ultimate aim was to generate demand and improve utilization of key maternal, neonatal, and child health services. The present study aims to assess the impact and cost-effectiveness of this project. Methods/design A pre–post quasi-experimental design with a control group will be used to undertake difference in differences analysis for assessing the impact of intervention. The Annual Health Survey (2011) will provide pre-intervention data, and a household survey will be carried out to provide post-intervention data. Two community development blocks where the intervention was introduced will be treated as intervention blocks while two controls blocks are selected after matching with intervention blocks on three indicators: average number of antenatal care checkups, percentage of women receiving three or more antenatal checkups, and percentage of institutional deliveries. Two categories of beneficiaries will be interviewed in both areas: women with a child between 29 days and 6 months and women with a child between 12 and 23 months. Propensity score matched samples from intervention and control areas in pre–post periods will be analyzed using the difference in differences method to estimate the impact of intervention in utilization of key services. Bottom-up costing methods will be used to assess the cost of implementing intervention. A decision model will estimate long-term effects of improved health services utilization on mortality, morbidity, and disability. Cost-effectiveness will be assessed in terms of incremental cost per disability-adjusted life year averted and cost per unit increase in composite service coverage in intervention versus control groups. Conclusions The study will generate significant evidence on impact of the m-health intervention for maternal, neonatal, and child services and on the

  12. A Study to Examine the Uses of Personal Strength in Relation to Mental Health Recovery in Adults with Serious Mental Illnesses: A Research Protocol

    PubMed Central

    Xie, Huiting; Yuan, Peng; Cui, Song Song; Yen, Melissa Sng Siok

    2015-01-01

    This study will explore the relationships among strengths self-efficacy, resourcefulness, stigma experience and mental health recovery in community-dwelling adults with serious mental illnesses. Mental health practices have focued on psychopathphysiology. Stigma heavily plagued clients with mental illnesses and is one of the greatest barriers to mental health recovery. Personal strengths like strengths self-efficacy, people’s confidence in using their personal strengths, and resourcefulness, the ability to carry out daily activities, have been linked to positive mental health. However, the linkage between strengths self-efficacy, resourcefulness and mental health recovery remains uncharted. A cross-sectional, descriptive, mixed methods study will be conducted. A funded study by the Sigma Theta Tau, Upsilon Eta Chapter, August 2013, involving a convenience sample of 100 participants is planned. Included are community dwelling adults between 21 to 65 years old having been diagnosed with serious mental illnesses. Clients with current co-occurring substance abuse will be excluded. Participants complete questionnaires and undergo an interview. Correlations among the study variables will be examined. Regression analysis will determine if recovery can be predicted by strengths self-efficacy, resourcefulness and stigma experience. Interview data will be transcribed and analyzed by thematic analysis. This study will look beyond clients’ disability to focus on their recovery and healing capacities such as strengths self-efficacy and resourcefulness. Findings will expand our knowledge about mental health recovery. Knowledge gained from this study may pave the way for future nursing strategies to aid recovery and inform the development of positive, strengths-based interventions. PMID:26973963

  13. Avian study protocols and wind energy development

    SciTech Connect

    Fisher, K.

    1995-12-01

    This paper identifies the need to develop and use standardized avian study protocols to determine avian impacts at new and existing wind energy facilities. This will allow data collected from various sites to be correlated for better understanding wind energy related avian impacts. Factors contributing to an increased interest in wind energy facilities by electric utilities include: (1) Increased demand for electricity;(2) increased constraints on traditional electrical generating facilities (i.e. hydroelectric and nuclear power plants);(3) improved wind turbine technology. During the 1980`s generous tax credits spawned the development of wind energy facilities, known as wind farms, in California. Commercial scale wind farm proposals are being actively considered in states across the country - Washington, Oregon, Wyoming, Wisconsin, Texas, and Vermont to name a few. From the wind farms in California the unexpected issue of avian impacts, especially to birds-of-prey, or raptor, surfaced and continues to plague the wind industry. However, most of the avian studies did not followed a standardized protocol or methodology and, therefore, data is unavailable to analyze and compare impacts at different sites or with differing technologies and configurations. Effective mitigation can not be designed and applied until these differences are understood. The Bonneville Power Administration is using comparable avian study protocols to collect data for two environmental impact statements being prepared for two separate wind farm proposals. Similar protocol will be required for any other avian impact analysis performed by the agency on proposed or existing wind farms. The knowledge gained from these studies should contribute to a better understanding of avian interactions with wind energy facilities and the identification of effective mitigation measures.

  14. Implementing a knowledge application program for anxiety and depression in community-based primary mental health care: a multiple case study research protocol

    PubMed Central

    2013-01-01

    Background Anxiety and depressive disorders are increasingly recognized as a health care policy priority. Reducing the treatment gap for common mental disorders requires strengthening the quality of primary mental health care. We developed a knowledge application program designed to improve the organization and delivery of care for anxiety and depression in community-based primary mental health care teams in Quebec, Canada. The principal objectives of the study are: to implement and evaluate this evidence-based knowledge application program; to examine the contextual factors associated with the selection of local quality improvement strategies; to explore barriers and facilitators associated with the implementation of local quality improvement plans; and to study the implementation of local quality monitoring strategies. Methods The research design is a mixed-methods prospective multiple case study. The main analysis unit (cases) is composed of the six multidisciplinary community-based primary mental health care teams, and each of the cases has identified at least one primary care medical clinic interested in collaborating with the implementation project. The training modules of the program are based on the Chronic Care Model, and the implementation strategies were developed according to the Promoting Action on Research Implementation in Health Services conceptual framework. Discussion The implementation of an evidence-based knowledge application program for anxiety and depression in primary care aims to improve the organization and delivery of mental health services. The uptake of evidence to improve the quality of care for common mental disorders in primary care is a complex process that requires careful consideration of the context in which innovations are introduced. The project will provide a close examination of the interplay between evidence, context and facilitation, and contribute to the understanding of factors associated with the process of

  15. Assessing the Impact and Cost of Short-Term Health Workforce in Remote Indigenous Communities in Australia: A Mixed Methods Study Protocol

    PubMed Central

    Humphreys, John; Bourke, Lisa; Dunbar, Terry; Jones, Michael; Carey, Timothy A; Guthridge, Steven; Russell, Deborah; Lyle, David; Zhao, Yuejen; Murakami-Gold, Lorna

    2016-01-01

    Background Remote Australia is a complex environment characterized by workforce shortages, isolated practice, a large resident Indigenous population, high levels of health need, and limited access to services. In recent years, there has been an increasing trend of utilizing a short-term visiting (fly-in/fly-out) health workforce in many remote areas. However, there is a dearth of evidence relating to the impact of this transitory workforce on the existing resident workforce, consumer satisfaction, and the effectiveness of current services. Objective This study aims to provide rigorous empirical data by addressing the following objectives: (1) to identify the impact of short-term health staff on the workload, professional satisfaction, and retention of resident health teams in remote areas; (2) to identify the impact of short-term health staff on the quality, safety, and continuity of patient care; and (3) to identify the impact of short-term health staff on service cost and effectiveness. Methods Mixed methods will be used. Administrative data will be extracted that relates to all 54 remote clinics managed by the Northern Territory Department of Health, covering a population of 35,800. The study period will be 2010 to 2014. All 18 Aboriginal Community-Controlled Health Services in the Northern Territory will also be invited to participate. We will use these quantitative data to describe staffing stability and turnover in these communities, and then utilize multiple regression analyses to determine associations between the key independent variables of interest (resident staff turnover, stability or median survival, and socioeconomic status, community size, and per capita funding) and dependent variables related to patient care, service cost, quality, and effectiveness. The qualitative component of the study will involve in-depth interviews and focus groups with staff and patients, respectively, in six remote communities. Three communities will be high staff turnover

  16. Improving adolescent mental health and resilience through a resilience-based intervention in schools: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Research investigating the effectiveness of universal interventions to reduce the risk of mental health problems remains limited. Schools are a promising setting within which adolescents can receive interventions aimed at promoting their mental health. The aim of this study is to assess the effectiveness of a resilience-based prevention-focused intervention in reducing the risk of mental health problems among adolescents attending secondary school in socio-economically disadvantaged areas. Methods/design A cluster randomised control trial will be conducted, with schools as the unit of randomisation. Initially, 32 secondary schools will be randomly allocated to a control or intervention group (12 control and 20 intervention). An intervention focused on improving student internal and external resilience factors will be implemented in intervention schools. A survey of students in Grade 7 in both intervention and control schools will be conducted (baseline) and repeated three years later when the students are in Grade 10. The Strengths and Difficulties Questionnaire will be used to measure the risk of mental health problems. At follow-up, the risk of mental health problems will be compared between Grade 10 students in intervention and control schools to determine intervention effectiveness. Discussion The study presents an opportunity to determine the effectiveness of a comprehensive resilience-based intervention in reducing the risk of mental health problems in adolescents attending secondary schools. The outcomes of the trial are of importance to youth, schools, mental health clinicians and policymakers. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12611000606987, registered 14 June 2011. PMID:25037455

  17. Urban upgrading and its impact on health: a "quasi-experimental" mixed-methods study protocol for the BH-Viva Project.

    PubMed

    Friche, Amélia Augusta de Lima; Dias, Maria Angélica de Salles; Reis, Priscila Brandão Dos; Dias, Cláudia Silva; Caiaffa, Waleska Teixeira

    2015-11-01

    There is little scientific evidence that urban upgrading helps improve health or reduce inequities. This article presents the design for the BH-Viva Project, a "quasi-experimental", multiphase, mixed-methods study with quantitative and qualitative components, proposing an analytical model for monitoring the effects that interventions in the urban environment can have on residents' health in slums in Belo Horizonte, Minas Gerais State, Brazil. A preliminary analysis revealed intra-urban differences in age-specific mortality when comparing areas with and without interventions; the mortality rate from 2002 to 2012 was stable in the "formal city", increased in slums without interventions, and decreased in slums with interventions. BH-Viva represents an effort at advancing methodological issues, providing learning and theoretical backing for urban health research and research methods, allowing their application and extension to other urban contexts.

  18. Urban upgrading and its impact on health: a "quasi-experimental" mixed-methods study protocol for the BH-Viva Project.

    PubMed

    Friche, Amélia Augusta de Lima; Dias, Maria Angélica de Salles; Reis, Priscila Brandão Dos; Dias, Cláudia Silva; Caiaffa, Waleska Teixeira

    2015-11-01

    There is little scientific evidence that urban upgrading helps improve health or reduce inequities. This article presents the design for the BH-Viva Project, a "quasi-experimental", multiphase, mixed-methods study with quantitative and qualitative components, proposing an analytical model for monitoring the effects that interventions in the urban environment can have on residents' health in slums in Belo Horizonte, Minas Gerais State, Brazil. A preliminary analysis revealed intra-urban differences in age-specific mortality when comparing areas with and without interventions; the mortality rate from 2002 to 2012 was stable in the "formal city", increased in slums without interventions, and decreased in slums with interventions. BH-Viva represents an effort at advancing methodological issues, providing learning and theoretical backing for urban health research and research methods, allowing their application and extension to other urban contexts. PMID:26648363

  19. Linking e-health records, patient-reported symptoms and environmental exposure data to characterise and model COPD exacerbations: protocol for the COPE study

    PubMed Central

    Moore, Elizabeth; Chatzidiakou, Lia; Jones, Roderic L; Smeeth, Liam; Beevers, Sean; Kelly, Frank J; Barratt, Benjamin

    2016-01-01

    Introduction Relationships between exacerbations of chronic obstructive pulmonary disease (COPD) and environmental factors such as temperature, humidity and air pollution are not well characterised, due in part to oversimplification in the assignment of exposure estimates to individuals and populations. New developments in miniature environmental sensors mean that patients can now carry a personal air quality monitor for long periods of time as they go about their daily lives. This creates the potential for capturing a direct link between individual activities, environmental exposures and the health of patients with COPD. Direct associations then have the potential to be scaled up to population levels and tested using advanced human exposure models linked to electronic health records. Methods and analysis This study has 5 stages: (1) development and deployment of personal air monitors; (2) recruitment and monitoring of a cohort of 160 patients with COPD for up to 6 months with recruitment of participants through the Clinical Practice Research Datalink (CPRD); (3) statistical associations between personal exposure with COPD-related health outcomes; (4) validation of a time-activity exposure model and (5) development of a COPD prediction model for London. Ethics and dissemination The Research Ethics Committee for Camden and Islington has provided ethical approval for the conduct of the study. Approval has also been granted by National Health Service (NHS) Research and Development and the Independent Scientific Advisory Committee. The results of the study will be disseminated through appropriate conference presentations and peer-reviewed journals. PMID:27412104

  20. PRISMA-Children (C) and PRISMA-Protocol for Children (P-C) Extensions: a study protocol for the development of guidelines for the conduct and reporting of systematic reviews and meta-analyses of newborn and child health research

    PubMed Central

    Kapadia, Mufiza Z; Askie, Lisa; Hartling, Lisa; Contopoulos-Ioannidis, Despina; Bhutta, Zulfiqar A; Soll, Roger; Moher, David; Offringa, Martin

    2016-01-01

    Introduction Paediatric systematic reviews differ from adult systematic reviews in several key aspects such as considerations of child tailored interventions, justifiable comparators, valid outcomes and child sensitive search strategies. Available guidelines, including PRISMA-P (2015) and PRISMA (2009), do not cover all the complexities associated with reporting systematic reviews in the paediatric population. Using a collaborative, multidisciplinary structure, we aim to develop evidence-based and consensus-based PRISMA-P-C (Protocol for Children) and PRISMA-C (Children) Extensions to guide paediatric systematic review protocol and completed review reporting. Methods and analysis This project's methodology follows published recommendations for developing reporting guidelines and involves the following six phases; (1) establishment of a steering committee representing key stakeholder groups; (2) a scoping review to identify potential Extension items; (3) three types of consensus activities including meetings of the steering committee to achieve high-level decisions on the content and methodology of the Extensions, a survey of key stakeholders to generate a list of possible items to include in the Extensions and a formal consensus meeting to select the reporting items to add to, or modify for, the Extension; (4) the preliminary checklist items generated in phase III will be evaluated against the existing evidence and reporting practices in paediatric systematic reviews; (5) extension statements and explanation and elaboration documents will provide detailed advice for each item and examples of good reporting; (6) development and implementation of effective knowledge translation of the extension checklist, and an evaluation of the Extensions by key stakeholders. Ethics and Dissemination This protocol was considered a quality improvement project by the Hospital for Sick Children's Ethics Committee and did not require ethical review. The resultant checklists, jointly

  1. Decline in hospital mortality rate after the use of the World Health Organization protocol for management of severe malnutrition.

    PubMed

    Falbo, Ana Rodrigues; Alves, João Guilherme Bezerra; Batista Filho, Malaquias; de Fátima Costa Caminha, Maria; Cabral-Filho, José Eulálio

    2009-04-01

    We studied the implementation of the World Health Organization protocol for the treatment of malnourished children at the largest maternal and infant hospital in the northeast of Brazil. The implementation of the protocol resulted in a reduction in the mortality rate from 38.0% to 16.2%.

  2. Designing a theory- and evidence-based tailored eHealth rehabilitation aftercare program in Germany and the Netherlands: study protocol

    PubMed Central

    2013-01-01

    Background Cardiac rehabilitation programs aim to improve health status and to decrease the risk of further cardiac events. Persons undergoing rehabilitation often have difficulties transferring the learned health behaviors into their daily routine after returning home and maybe to work. This includes physical activity as well as fruit and vegetable consumption. Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption. The aim of this study is, to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation. Methods The study will have a randomized controlled design and will be conducted among German and Dutch people who participated in cardiac rehabilitation. The study will consist of one intervention group which will be compared to a waiting list control group. During the eight week duration of the intervention, participants will be invited to participate in the online after-care program once per week. The intervention encourages participants to define individual health behavior goals as well as action, and coping plans to reach these self-determined goals. The effectiveness of the program will be compared between the intervention condition and the control group in terms of behavior change, antecedents of behavior change (e.g., self-efficacy), ability to return to work and increased well-being. Further, subgroup-differences will be assessed including differences between the two countries, socioeconomic inequalities and across age groups. Discussion The present study will make a contribution to understanding how such an online-based tailored interventions enables study participants to adopt and maintain a healthy lifestyle. Implications can include how such an online program could enrich cardiac rehabilitation aftercare further. Trial registration NTR 3706, NCT01909349 PMID:24245493

  3. Methodological characteristics and treatment effect sizes in oral health randomised controlled trials: Is there a relationship? Protocol for a meta-epidemiological study

    PubMed Central

    Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

    2014-01-01

    Introduction It is fundamental that randomised controlled trials (RCTs) are properly conducted in order to reach well-supported conclusions. However, there is emerging evidence that RCTs are subject to biases which can overestimate or underestimate the true treatment effect, due to flaws in the study design characteristics of such trials. The extent to which this holds true in oral health RCTs, which have some unique design characteristics compared to RCTs in other health fields, is unclear. As such, we aim to examine the empirical evidence quantifying the extent of bias associated with methodological and non-methodological characteristics in oral health RCTs. Methods and analysis We plan to perform a meta-epidemiological study, where a sample size of 60 meta-analyses (MAs) including approximately 600 RCTs will be selected. The MAs will be randomly obtained from the Oral Health Database of Systematic Reviews using a random number table; and will be considered for inclusion if they include a minimum of five RCTs, and examine a therapeutic intervention related to one of the recognised dental specialties. RCTs identified in selected MAs will be subsequently included if their study design includes a comparison between an intervention group and a placebo group or another intervention group. Data will be extracted from selected trials included in MAs based on a number of methodological and non-methodological characteristics. Moreover, the risk of bias will be assessed using the Cochrane Risk of Bias tool. Effect size estimates and measures of variability for the main outcome will be extracted from each RCT included in selected MAs, and a two-level analysis will be conducted using a meta-meta-analytic approach with a random effects model to allow for intra-MA and inter-MA heterogeneity. Ethics and dissemination The intended audiences of the findings will include dental clinicians, oral health researchers, policymakers and graduate students. The aforementioned will be

  4. A health economic model for the development and evaluation of innovations in aged care: an application to consumer-directed care—study protocol

    PubMed Central

    Ratcliffe, Julie; Lancsar, Emily; Luszcz, Mary; Crotty, Maria; Gray, Len; Paterson, Jan; Cameron, Ian D

    2014-01-01

    Introduction Consumer-directed care is currently being embraced within Australia and internationally as a means of promoting autonomy and choice in the delivery of health and aged care services. Despite its wide proliferation little research has been conducted to date to assess the views and preferences of older people for consumer-directed care or to assess the costs and benefits of such an approach relative to existing models of service delivery. Methods and analysis A comprehensive health economic model will be developed and applied to the evolution, implementation and evaluation of consumer-directed care in an Australian community aged care setting. A mixed methods approach comprising qualitative interviews and a discrete choice experiment will determine the attitudes and preferences of older people and their informal carers for consumer-directed care. The results of the qualitative interviews and the discrete choice experiment will inform the introduction of a new consumer-directed care innovation in service delivery. The cost-effectiveness of consumer-directed care will be evaluated by comparing incremental changes in resource use, costs and health and quality of life outcomes relative to traditional services. The discrete choice experiment will be repeated at the end of the implementation period to determine the extent to which attitudes and preferences change as a consequence of experience of consumer-directed care. The proposed framework will have wide applicability in the future development and economic evaluation of new innovations across the health and aged care sectors. Ethics and dissemination The study is approved by Flinders University Social and Behavioural Research Ethics Committee (Project No. 6114/SBREC). Findings from the qualitative interviews, discrete choice experiments and the economic evaluation will be reported at a workshop of stakeholders to be held in 2015 and will be documented in reports and in peer reviewed journal articles. PMID

  5. Expectations, experiences and attitudes of patients and primary care health professionals regarding online psychotherapeutic interventions for depression: protocol for a qualitative study

    PubMed Central

    2013-01-01

    Background In the year 2020, depression will cause the second highest amount of disability worldwide. One quarter of the population will suffer from depression symptoms at some point in their lives. Mental health services in Western countries are overburdened. Therefore, cost-effective interventions that do not involve mental health services, such as online psychotherapy programs, have been proposed. These programs demonstrate satisfactory outcomes, but the completion rate for patients is low. Health professionals’ attitudes towards this type of psychotherapy are more negative than the attitudes of depressed patients themselves. The aim of this study is to describe the profile of depressed patients who would benefit most from online psychotherapy and to identify expectations, experiences, and attitudes about online psychotherapy among both patients and health professionals that can facilitate or hinder its effects. Methods A parallel qualitative design will be used in a randomised controlled trial on the efficiency of online psychotherapeutic treatment for depression. Through interviews and focus groups, the experiences of treated patients, their reasons for abandoning the program, the expectations of untreated patients, and the attitudes of health professionals will be examined. Questions will be asked about training in new technologies, opinions of online psychotherapy, adjustment to therapy within the daily routine, the virtual and anonymous relationship with the therapist, the process of online communication, information necessary to make progress in therapy, process of working with the program, motivations and attitudes about treatment, expected consequences, normalisation of this type of therapy in primary care, changes in the physician-patient relationship, and resources and risks. A thematic content analysis from the grounded theory for interviews and an analysis of the discursive positions of participants based on the sociological model for focus groups

  6. Rural Versus Urban Health Service Utilization and Outcomes for Renal Patients in New South Wales: Protocol for a Data Linkage Study

    PubMed Central

    Webster, Angela; Cass, Alan; Gallagher, Martin

    2015-01-01

    Background Kidney disease is a significant burden on health systems globally, with the rising prevalence of end stage kidney disease in Australia mirrored in many other countries. Approximately 25% of the Australian population lives in regional and rural areas and accessing complex tertiary services is challenging. Objective We aim to compare the burden and outcomes of chronic kidney disease and end stage kidney disease in rural and urban regions of New South Wales (Australia’s most populous state) using linked health data. Methods This is a retrospective cohort study and we have defined two cohorts: one with end stage kidney disease and one with chronic kidney disease. The end stage kidney disease cohort was defined using the Australia and New Zealand Dialysis and Transplant Registry, identifying all patients living in NSW receiving renal replacement therapy at any time between 01/07/2000 and 31/07/2010. The chronic kidney disease cohort used the NSW Admitted Patient Data Collection (APDC) to identify patients with a diagnostic code relating to chronic renal failure during any admission between 01/07/2000 and 31/07/2010. Both cohorts were linked to the NSW APDC, the Registry of Births, Deaths and Marriages, and the Central Cancer Registry allowing derivation of outcomes by categories of geographical remoteness. Results To date, we have identified 10,505 patients with 2,384,218 records in the end stage kidney disease cohort and 159,033 patients with 1,599,770 records in the chronic kidney disease cohort. Conclusions This study will define the geographical distribution of end stage and chronic kidney disease and compare the health service utilization between rural and urban renal populations. PMID:26082088

  7. Protocol for a mixed methods study investigating the impact of investment in housing, regeneration and neighbourhood renewal on the health and wellbeing of residents: the GoWell programme

    PubMed Central

    2010-01-01

    Background There is little robust evidence to test the policy assumption that housing-led area regeneration strategies will contribute to health improvement and reduce social inequalities in health. The GoWell Programme has been designed to measure effects on health and wellbeing of multi-faceted regeneration interventions on residents of disadvantaged neighbourhoods in the city of Glasgow, Scotland. Methods/Design This mixed methods study focused (initially) on 14 disadvantaged neighbourhoods experiencing regeneration. These were grouped by intervention into 5 categories for comparison. GoWell includes a pre-intervention householder survey (n = 6008) and three follow-up repeat-cross sectional surveys held at two or three year intervals (the main focus of this protocol) conducted alongside a nested longitudinal study of residents from 6 of those areas. Self-reported responses from face-to-face questionnaires are analysed along with various routinely produced ecological data and documentary sources to build a picture of the changes taking place, their cost and impacts on residents and communities. Qualitative methods include interviews and focus groups of residents, housing managers and other stakeholders exploring issues such as the neighbourhood context, potential pathways from regeneration to health, community engagement and empowerment. Discussion Urban regeneration programmes are 'natural experiments.' They are complex interventions that may impact upon social determinants of population health and wellbeing. Measuring the effects of such interventions is notoriously challenging. GoWell compares the health and wellbeing effects of different approaches to regeneration, generates theory on pathways from regeneration to health and explores the attitudes and responses of residents and other stakeholders to neighbourhood change. PMID:20459767

  8. Physical activity and the rejuvenation of Connswater (PARC study): protocol for a natural experiment investigating the impact of urban regeneration on public health

    PubMed Central

    2013-01-01

    potential, individually and interactively, to affect the behaviour of a diverse population. The development and implementation of our comprehensive evaluation framework reflects this complexity and illuminates an approach to the empirical, rigorous evaluation of urban regeneration. More specifically, this study will add to the much needed evidence-base about the impact of urban regeneration on public health as well as having important implications for the development of natural experiment methodology. PMID:24103381

  9. Effective components of feedback from Routine Outcome Monitoring (ROM) in youth mental health care: study protocol of a three-arm parallel-group randomized controlled trial

    PubMed Central

    2014-01-01

    Background Routine Outcome Monitoring refers to regular measurements of clients’ progress in clinical practice, aiming to evaluate and, if necessary, adapt treatment. Clients fill out questionnaires and clinicians receive feedback about the results. Studies concerning feedback in youth mental health care are rare. The effects of feedback, the importance of specific aspects of feedback, and the mechanisms underlying the effects of feedback are unknown. In the present study, several potentially effective components of feedback from Routine Outcome Monitoring in youth mental health care in the Netherlands are investigated. Methods/Design We will examine three different forms of feedback through a three-arm parallel-group randomized controlled trial. 432 children and adolescents (aged 4 to 17 years) and their parents, who have been referred to mental health care institution Pro Persona, will be randomly assigned to one of three feedback conditions (144 participants per condition). Randomization will be stratified by age of the child or adolescent and by department. All participants fill out questionnaires at the start of treatment, one and a half months after the start of treatment, every three months during treatment, and at the end of treatment. Participants in the second and third feedback conditions fill out an additional questionnaire. In condition 1, clinicians receive basic feedback regarding clients’ symptoms and quality of life. In condition 2, the feedback of condition 1 is extended with feedback regarding possible obstacles to a good outcome and with practical suggestions. In condition 3, the feedback of condition 2 is discussed with a colleague while following a standardized format for case consultation. The primary outcome measure is symptom severity and secondary outcome measures are quality of life, satisfaction with treatment, number of sessions, length of treatment, and rates of dropout. We will also examine the role of being not on track (not

  10. The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting

    PubMed Central

    Palmer, Victoria J; Chondros, Patty; Piper, Donella; Callander, Rosemary; Weavell, Wayne; Godbee, Kali; Potiriadis, Maria; Richard, Lauralie; Densely, Konstancja; Herrman, Helen; Furler, John; Pierce, David; Schuster, Tibor; Iedema, Rick; Gunn, Jane

    2015-01-01

    Introduction User engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement improve health outcomes? This article describes the CORE study protocol, a novel stepped wedge cluster randomised controlled trial (SWCRCT) to improve psychosocial recovery outcomes for people with severe mental illness. Methods An SWCRCT with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. The intervention, a modified version of Mental Health Experience Co-Design (MH ECO), will be delivered to 30 service users, 30 carers and 10 staff in each cluster. Outcome data will be collected at baseline (6 months) and at completion of each intervention wave. The primary outcome is improvement in recovery score using the 24-item Revised Recovery Assessment Scale for service users. Secondary outcomes are improvements to user and carer mental health and well-being using the shortened 8-item version of the WHOQOL Quality of Life scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale and recovery orientation of services using the 36-item Recovery Self Assessment Scale (provider version). Intervention and usual care periods will be compared using a linear mixed effects model for continuous outcomes and a generalised linear mixed effects model for binary outcomes. Participants will be analysed in the group that the cluster was assigned to at each time point. Ethics and dissemination The University of Melbourne, Human Research Ethics Committee (1340299.3) and the Federal and State Departments of Health Committees (Project 20/2014) granted ethics approval. Baseline data results will be reported in 2015 and outcomes data in 2017. Trial registration number Australian and New Zealand Clinical Trials Registry ACTRN

  11. Study on the conversion and test of protocols

    NASA Astrophysics Data System (ADS)

    Choi, Y.

    1984-06-01

    The conversion of protocols nonadapted to the open systems interconnection (OSI) architecture into compatibility with the OSI system and the test of the equipment for converting protocols are studied. Specification and validation of protocols are reviewed. The test of the X-21 procedure and the test of the signal management equipment, parts of the Telecom project, are analyzed. A specification method based on extended finite state machines is developed. A test system for protocol conversion equipment is described.

  12. Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Pressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment. Methods/design The main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student’s t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis. Discussion The

  13. Vascular Health Assessment of The Hypertensive Patients (VASOTENS) Registry: Study Protocol of an International, Web-Based Telemonitoring Registry for Ambulatory Blood Pressure and Arterial Stiffness

    PubMed Central

    Parati, Gianfranco; Avolio, Alberto; Rogoza, Anatoly N; Kotovskaya, Yulia V; Mulè, Giuseppe; Muiesan, Maria Lorenza; Orlova, Iana A; Grigoricheva, Elena A; Cardona Muñoz, Ernesto; Zelveian, Parounak H; Pereira, Telmo; Peixoto Maldonado, João Manuel

    2016-01-01

    Background Hypertension guidelines recommend ambulatory blood pressure (ABP), central aortic pressure (CAP), and pulse wave velocity (PWV) as parameters for estimating blood pressure (BP) control and vascular impairment. Recent advances in technology have enabled devices to combine non-invasive estimation of these parameters over the 24-hour ABP monitoring. However, currently there is limited evidence on the usefulness of such an approach for routine hypertension management. Objective We recently launched an investigator-initiated, international, multicenter, observational, prospective study, the Vascular health Assessment Of The Hypertensive patients (VASOTENS) Registry, aimed at (1) evaluating non-invasive 24-hour ABP and arterial stiffness estimates (through 24-hour pulse wave analysis, PWA) in hypertensive subjects undergoing ambulatory blood pressure monitoring (ABPM) for clinical reasons; (2) assessing the changes in estimates following treatment; (3) weighing the impact of 24-hour PWA on target organ damage and cardiovascular prognosis; (4) assessing the relationship between arterial stiffness, BP absolute mean level and variability, and prognosis; and (5) validating the use of a 24-hour PWA electronic health (e-health) solution for hypertension screening. Methods Approximately 2000 subjects, referred to 20 hypertension clinics for routine diagnostic evaluation and follow-up of hypertension of any severity or stage, will be recruited. Data collection will include ABPM, performed with a device allowing simultaneous non-invasive assessment of 24-hour CAP and arterial stiffness (BPLab), and clinical data (including cardiovascular outcomes). As recommended by current guidelines, each patient will be followed-up with visits occurring at regular intervals (ideally every 6 months, and not less than once a year depending on disease severity). A Web-based telemedicine platform (THOLOMEUS) will be used for data collection. The use of the telemedicine system will allow

  14. Impact of a Telenursing service on satisfaction and health outcomes of children with inflammatory rheumatic diseases and their families: a crossover randomized trial study protocol

    PubMed Central

    2014-01-01

    Background Pediatric rheumatic diseases have a significant impact on children’s quality of life and family functioning. Disease control and management of the symptoms are important to minimize disability and pain. Specialist clinical nurses play a key role in supporting medical teams, recognizing poor disease control and the need for treatment changes, providing a resource to patients on treatment options and access to additional support and advice, and identifying best practices to achieve optimal outcomes for patients and their families. This highlights the importance of investigating follow-up telenursing (TN) consultations with experienced, specialist clinical nurses in rheumatology to provide this support to children and their families. Methods/Design This randomized crossover, experimental longitudinal study will compare the effects of standard care against a novel telenursing consultation on children’s and family outcomes. It will examine children below 16 years old, recently diagnosed with inflammatory rheumatic diseases, who attend the pediatric rheumatology outpatient clinic of a tertiary referral hospital in western Switzerland, and one of their parents. The telenursing consultation, at least once a month, by a qualified, experienced, specialist nurse in pediatric rheumatology will consist of providing affective support, health information, and aid to decision-making. Cox’s Interaction Model of Client Health Behavior serves as the theoretical framework for this study. The primary outcome measure is satisfaction and this will be assessed using mixed methods (quantitative and qualitative data). Secondary outcome measures include disease activity, quality of life, adherence to treatment, use of the telenursing service, and cost. We plan to enroll 56 children. Discussion The telenursing consultation is designed to support parents and children/adolescents during the course of the disease with regular follow-up. This project is novel because it is based

  15. [The research protocol III. Study population].

    PubMed

    Arias-Gómez, Jesús; Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The study population is defined as a set of cases, determined, limited, and accessible, that will constitute the subjects for the selection of the sample, and must fulfill several characteristics and distinct criteria. The objectives of this manuscript are focused on specifying each one of the elements required to make the selection of the participants of a research project, during the elaboration of the protocol, including the concepts of study population, sample, selection criteria and sampling methods. After delineating the study population, the researcher must specify the criteria that each participant has to comply. The criteria that include the specific characteristics are denominated selection or eligibility criteria. These criteria are inclusion, exclusion and elimination, and will delineate the eligible population. The sampling methods are divided in two large groups: 1) probabilistic or random sampling and 2) non-probabilistic sampling. The difference lies in the employment of statistical methods to select the subjects. In every research, it is necessary to establish at the beginning the specific number of participants to be included to achieve the objectives of the study. This number is the sample size, and can be calculated or estimated with mathematical formulas and statistic software. PMID:27174763

  16. [The research protocol III. Study population].

    PubMed

    Arias-Gómez, Jesús; Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The study population is defined as a set of cases, determined, limited, and accessible, that will constitute the subjects for the selection of the sample, and must fulfill several characteristics and distinct criteria. The objectives of this manuscript are focused on specifying each one of the elements required to make the selection of the participants of a research project, during the elaboration of the protocol, including the concepts of study population, sample, selection criteria and sampling methods. After delineating the study population, the researcher must specify the criteria that each participant has to comply. The criteria that include the specific characteristics are denominated selection or eligibility criteria. These criteria are inclusion, exclusion and elimination, and will delineate the eligible population. The sampling methods are divided in two large groups: 1) probabilistic or random sampling and 2) non-probabilistic sampling. The difference lies in the employment of statistical methods to select the subjects. In every research, it is necessary to establish at the beginning the specific number of participants to be included to achieve the objectives of the study. This number is the sample size, and can be calculated or estimated with mathematical formulas and statistic software.

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

  19. Mindfulness-based cognitive therapy (MBCT) versus the health-enhancement program (HEP) for adults with treatment-resistant depression: a randomized control trial study protocol

    PubMed Central

    2014-01-01

    Background Major depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have “treatment-resistant depression” (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial. Methods/Design The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1–7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology

  20. Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Downing Jr, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

    2016-01-01

    Background Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. Objective To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Methods Sex Positive![+] is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Results Participant recruitment began in June 2015 and ended in December 2015. Conclusions This protocol

  1. From Postpartum Haemorrhage Guideline to Local Protocol: A Study of Protocol Quality.

    PubMed

    Woiski, Mallory D; van Vugt, Helena C; Dijkman, Anneke; Grol, Richard P; Marcus, Abraham; Middeldorp, Johanna M; Mol, Ben W; Mols, Femke; Oudijk, Martijn A; Porath, Martina; Scheepers, Hubertina J; Hermens, Rosella P

    2016-10-01

    Objective Postpartum hemorrhage (PPH) has a continuously rising incidence worldwide, suggesting suboptimal care. An important step in optimizing care is the translation of evidence-based guidelines into comprehensive hospital protocols. However, knowledge about the quality of these protocols is lacking. The objective of this study was to evaluate the quality of PPH-protocols on structure and content in the Netherlands. Methods We performed an observational multicenter study. Eighteen PPH-protocols from 3 University Hospitals (UH), 8 Teaching Hospitals (TH) and 7 Non-Teaching hospitals (NTH) throughout the Netherlands were acquired. The structure of the PPH-protocols was assessed using the Appraisal of Guidelines for Research and Evaluation (AGREE-II) Instrument. The content was appraised using previously developed quality indicators, based on international guidelines and Advance-Trauma-Life-Support (ATLS)-based course instructions. Results The quality of the protocols for postpartum hemorrhage for both structure and content varied widely between different hospitals, but all of them showed room for improvement. The protocols scored mainly below average on the different items of the AGREE-II instrument (8 of the 10 items scored <4 on a 1-7 scale). Regarding the content, adoption of guideline recommendations in protocols was 46 %. In addition, a timely indication of 'when to perform' a recommendation was lacking in three-fourths of the items. Conclusion This study shows that the quality of the PPH-protocols for both structure and content in the Netherlands is suboptimal. This makes adherence to the guideline and ATLS-based course instructions difficult. PMID:27395381

  2. Improving physical health and reducing substance use in psychosis – randomised control trial (IMPACT RCT): study protocol for a cluster randomised controlled trial

    PubMed Central

    2013-01-01

    Background Cardiovascular morbidity and mortality is increased in individuals with severe mental illnesses. We set out to establish a multicentre, two arm, parallel cluster randomized controlled trial (RCT) of a health promotion intervention (HPI), IMPACT Therapy. The patient-tailored IMPACT Therapy aims to target one or more health behaviours from a pre-defined list that includes cannabis use; alcohol use; other substance use; cigarette smoking; exercise; diet and diabetic control, prioritising those identified as problematic by the patient, taking a motivational interviewing and CBT approach. Methods Impact therapy will be delivered by care coordinators in the community to the treatment group and will be compared to treatment as usual (TAU). The main hypothesis is that the addition of IMPACT Therapy (HPI) to TAU will be more effective than TAU alone in improving patients’ quality of life as measured by the Short Form-36, including mental health and physical health subscales on completion of the intervention at 12 months post randomisation. A subsidiary hypothesis will be that addition of IMPACT Therapy (HPI) will be more cost-effective than TAU alone in improving health in people with SMI 12 months from baseline. The IMPACT therapy patient groups’ improvement in quality of life, as well as its cost effectiveness, is hypothesised to be maintained at 15 months. Outcomes will be analyzed on an intention-to-treat (ITT) basis. Discussion The results of the trial will provide information about the effectiveness of the IMPACT therapy programme in supporting community mental health teams to address physical comorbidity in severe mental illness. Trial registration ISRCTN58667926. PMID:24131496

  3. HEALTH-SCREENING PROTOCOLS FOR VINACEOUS AMAZONS (AMAZONA VINACEA) IN A REINTRODUCTION PROJECT.

    PubMed

    Saidenberg, André B S; Zuniga, Eveline; Melville, Priscilla A; Salaberry, Sandra; Benites, Nilson R

    2015-12-01

    Reintroduction is a growing field in the conservation of endangered species. The vinaceous Amazon parrot (Amazona vinacea) is extinct in several areas, and a project to release confiscated individuals to their former range is currently underway. The objective of this study was to evaluate and improve the selection and treatment of individual release candidates by detecting possible pathogen carriers using samples taken before and during release. As part of prerelease health protocols, samples were obtained from 29 parrots on three different occasions while in captivity and once after their release. Samples were screened for paramyxovirus type 1, avian influenza, poxvirus, coronavirus, psittacine herpesvirus 1, Chlamydia psittaci , enteropathogenic Escherichia coli (EPEC), Salmonella spp., and endoparasites. The majority of samples returned negative results, with the exception of two individuals that tested positive for C. psittaci in the first sampling and for Ascaridia spp. in the second pooled sampling. Treatments for C. psittaci and endoparasites were administered prior to release, and negative results were obtained in subsequent exams. The number of positive results for E. coli (non-EPEC) decreased during the rehabilitation period. Adequate quarantine procedures and health examinations greatly minimize disease risks. The protocols employed in this study resulted in acceptable health status in accordance with current environmental legislation in Brazil. Additionally, protocols allowed informed decisions to release candidates, minimized risks, and favored the selection of healthy individuals, thereby contributing to the recovery of this species. It is important to determine appropriate minimum health-screening protocols when advanced diagnostics may not be available or high costs make the tests prohibitive in countries where confiscations occur. We hypothesize that a minimum panel of tests of pooled samples can serve as an alternative approach that minimizes

  4. HEALTH-SCREENING PROTOCOLS FOR VINACEOUS AMAZONS (AMAZONA VINACEA) IN A REINTRODUCTION PROJECT.

    PubMed

    Saidenberg, André B S; Zuniga, Eveline; Melville, Priscilla A; Salaberry, Sandra; Benites, Nilson R

    2015-12-01

    Reintroduction is a growing field in the conservation of endangered species. The vinaceous Amazon parrot (Amazona vinacea) is extinct in several areas, and a project to release confiscated individuals to their former range is currently underway. The objective of this study was to evaluate and improve the selection and treatment of individual release candidates by detecting possible pathogen carriers using samples taken before and during release. As part of prerelease health protocols, samples were obtained from 29 parrots on three different occasions while in captivity and once after their release. Samples were screened for paramyxovirus type 1, avian influenza, poxvirus, coronavirus, psittacine herpesvirus 1, Chlamydia psittaci , enteropathogenic Escherichia coli (EPEC), Salmonella spp., and endoparasites. The majority of samples returned negative results, with the exception of two individuals that tested positive for C. psittaci in the first sampling and for Ascaridia spp. in the second pooled sampling. Treatments for C. psittaci and endoparasites were administered prior to release, and negative results were obtained in subsequent exams. The number of positive results for E. coli (non-EPEC) decreased during the rehabilitation period. Adequate quarantine procedures and health examinations greatly minimize disease risks. The protocols employed in this study resulted in acceptable health status in accordance with current environmental legislation in Brazil. Additionally, protocols allowed informed decisions to release candidates, minimized risks, and favored the selection of healthy individuals, thereby contributing to the recovery of this species. It is important to determine appropriate minimum health-screening protocols when advanced diagnostics may not be available or high costs make the tests prohibitive in countries where confiscations occur. We hypothesize that a minimum panel of tests of pooled samples can serve as an alternative approach that minimizes

  5. Large-scale investment in green space as an intervention for physical activity, mental and cardiometabolic health: study protocol for a quasi-experimental evaluation of a natural experiment

    PubMed Central

    Astell-Burt, Thomas; Feng, Xiaoqi; Kolt, Gregory S

    2016-01-01

    Introduction ‘Green spaces’ such as public parks are regarded as determinants of health, but evidence from tends to be based on cross-sectional designs. This protocol describes a study that will evaluate a large-scale investment in approximately 5280 hectares of green space stretching 27 km north to south in Western Sydney, Australia. Methods and analysis A Geographic Information System was used to identify 7272 participants in the 45 and Up Study baseline data (2006–2008) living within 5 km of the Western Sydney Parklands and some of the features that have been constructed since 2009, such as public access points, advertising billboards, walking and cycle tracks, BBQ stations, and children's playgrounds. These data were linked to information on a range of health and behavioural outcomes, with the second wave of data collection initiated by the Sax Institute in 2012 and expected to be completed by 2015. Multilevel models will be used to analyse potential change in physical activity, weight status, social contacts, mental and cardiometabolic health within a closed sample of residentially stable participants. Comparisons between persons with contrasting proximities to different areas of the Parklands will provide ‘treatment’ and ‘control’ groups within a ‘quasi-experimental’ study design. In line with expectations, baseline results prior to the enhancement of the Western Sydney Parklands indicated virtually no significant differences in the distribution of any of the outcomes with respect to proximity to green space preintervention. Ethics and dissemination Ethical approval was obtained for the 45 and Up Study from the University of New South Wales Human Research Ethics Committee. Ethics approval for this study was obtained from the University of Western Sydney Ethics Committee. Findings will be disseminated through partner organisations (the Western Sydney Parklands and the National Heart Foundation of Australia), as well as to policymakers in

  6. Health Worker Compliance with a ‘Test And Treat’ Malaria Case Management Protocol in Papua New Guinea

    PubMed Central

    Pulford, Justin; Smith, Iso; Mueller, Ivo; Siba, Peter M.; Hetzel, Manuel W.

    2016-01-01

    The Papua New Guinea (PNG) Department of Health introduced a ‘test and treat’ malaria case management protocol in 2011. This study assesses health worker compliance with the test and treat protocol on a wide range of measures, examines self-reported barriers to health worker compliance as well as health worker attitudes towards the test and treat protocol. Data were collected by cross-sectional survey conducted in randomly selected primary health care facilities in 2012 and repeated in 2014. The combined survey data included passive observation of current or recently febrile patients (N = 771) and interviewer administered questionnaires completed with health workers (N = 265). Across the two surveys, 77.6% of patients were tested for malaria infection by rapid diagnostic test (RDT) or microscopy, 65.6% of confirmed malaria cases were prescribed the correct antimalarials and 15.3% of febrile patients who tested negative for malaria infection were incorrectly prescribed an antimalarial. Overall compliance with a strictly defined test and treat protocol was 62.8%. A reluctance to test current/recently febrile patients for malaria infection by RDT or microscopy in the absence of acute malaria symptoms, reserving recommended antimalarials for confirmed malaria cases only and choosing to clinically diagnose a malaria infection, despite a negative RDT result were the most frequently reported barriers to protocol compliance. Attitudinal support for the test and treat protocol, as assessed by a nine-item measure, improved across time. In conclusion, health worker compliance with the full test and treat malaria protocol requires improvement in PNG and additional health worker support will likely be required to achieve this. The broader evidence base would suggest any such support should be delivered over a longer period of time, be multi-dimensional and multi-modal. PMID:27391594

  7. A lifestyle intervention supported by mobile health technologies to improve the cardiometabolic risk profile of individuals at risk for cardiovascular disease and type 2 diabetes: study rationale and protocol

    PubMed Central

    2013-01-01

    Background Metabolic syndrome is a cluster of cardiovascular risk factors that greatly increase the risk of developing cardiovascular disease and type 2 diabetes. Regular exercise improves the risk profile, but most people do not successfully change their exercise habits to beneficially reduce risk. Tailored exercise prescribed by a family physician has shown promise as a means to increase fitness and reduce cardiometabolic risk, but optimal implementation practices remain unknown. Mobile health technologies have proved to be a beneficial tool to achieve blood pressure and blood glucose control in patients with diabetes. These technologies may address the limited access to health interventions in rural and remote regions. However, the potential as a tool to support exercise-based prevention activities is not well understood. This study was undertaken to investigate the effects of a tailored exercise prescription alone or supported by mobile health technologies to improve metabolic syndrome and related cardiometabolic risk factors in rural community-dwelling adults at risk for cardiovascular disease and type 2 diabetes. Methods/Design Adults (n = 149) with at least two metabolic syndrome risk factors were recruited from rural communities and randomized to either: 1) an intervention group receiving an exercise prescription and devices for monitoring of risk factors with a smartphone data portal equipped with a mobile health application; or 2) an active control group receiving only an exercise prescription. All participants reported to the research centre at baseline, and at 12-, 24- and 52-week follow-up visits for measurement of anthropometrics and blood pressure and for a blood draw to test blood-borne markers of cardiometabolic health. Vascular and autonomic function were examined. Fitness was assessed and exercise prescribed according to the Step Test and Exercise Prescription protocol. Discussion This study tested the effects of a prescriptive exercise

  8. Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial

    PubMed Central

    Wozney, Lori; Bagnell, Alexa; Fitzpatrick, Eleanor; Curtis, Sarah; Jabbour, Mona; Johnson, David; Rosychuk, Rhonda J; Young, Michael; Ohinmaa, Arto; Joyce, Anthony; McGrath, Patrick

    2016-01-01

    Background There is a demand to make first-line treatments, including cognitive behavioural therapy (CBT) for adolescent anxiety disorders, more widely available. Internet-based CBT is proposed to circumvent access and availability barriers and reduce health care system costs. Recent reviews suggest more evidence is needed to establish the treatment effects of Internet-based CBT in children and adolescents and to determine related economic impacts. Objective This pilot trial aims to collect the necessary data to inform the planning of a full-scale RCT to test the effectiveness of the Internet-based CBT program Breathe (Being Real, Easing Anxiety: Tools Helping Electronically). Methods We are conducting a 27-month, 2-arm parallel-group, pilot randomized controlled trial (RCT). Outcomes will inform the planning of a full-scale RCT aimed to test the effectiveness of Internet-based CBT with a population of adolescents with moderate to mild anxiety problems. In the pilot RCT we will: (1) define a minimal clinically important difference (MCID) for the primary outcome measure (total anxiety score using the Multidimensional Anxiety Scale for Children); (2) determine a sample size for the full-scale RCT; (3) estimate recruitment and retention rates; (4) measure intervention acceptability to inform critical intervention changes; (5) determine the use of co-interventions; and (6) conduct a cost-consequence analysis to inform a cost-effectiveness analysis in the full-scale RCT. Adolescents aged 13-17 years seeking care for an anxiety complaint from a participating emergency department, mobile or school-based crisis team, or primary care clinic are being screened for interest and eligibility. Enrolled adolescents are being randomly allocated to either 8 weeks of Internet-based CBT with limited telephone and e-mail support, or a control group with access to a static webpage listing anxiety resources. Adolescents are randomly assigned using a computer generated allocation

  9. A Participatory Approach to Designing and Enhancing Integrated Health Information Technology Systems for Veterans: Protocol

    PubMed Central

    Nazi, Kim M; Chavez, Margeaux; Lind, Jason D; Antinori, Nicole; Gosline, Robert M; Martin, Tracey L

    2015-01-01

    Background The Department of Veterans Affairs (VA) has developed health information technologies (HIT) and resources to improve veteran access to health care programs and services, and to support a patient-centered approach to health care delivery. To improve VA HIT access and meaningful use by veterans, it is necessary to understand their preferences for interacting with various HIT resources to accomplish health management related tasks and to exchange information. Objective The objective of this paper was to describe a novel protocol for: (1) developing a HIT Digital Health Matrix Model; (2) conducting an Analytic Hierarchy Process called pairwise comparison to understand how and why veterans want to use electronic health resources to complete tasks related to health management; and (3) developing visual modeling simulations that depict veterans’ preferences for using VA HIT to manage their health conditions and exchange health information. Methods The study uses participatory research methods to understand how veterans prefer to use VA HIT to accomplish health management tasks within a given context, and how they would like to interact with HIT interfaces (eg, look, feel, and function) in the future. This study includes two rounds of veteran focus groups with self-administered surveys and visual modeling simulation techniques. This study will also convene an expert panel to assist in the development of a VA HIT Digital Health Matrix Model, so that both expert panel members and veteran participants can complete an Analytic Hierarchy Process, pairwise comparisons to evaluate and rank the applicability of electronic health resources for a series of health management tasks. Results This protocol describes the iterative, participatory, and patient-centered process for: (1) developing a VA HIT Digital Health Matrix Model that outlines current VA patient-facing platforms available to veterans, describing their features and relevant contexts for use; and (2

  10. Evaluation of an electronic health record-supported obesity management protocol implemented in a community health center: a cautionary note

    PubMed Central

    Sommers, Mary; Talen, Mary R; Thornton, Louise K; Spring, Bonnie

    2015-01-01

    Objective Primary care clinicians are well-positioned to intervene in the obesity epidemic. We studied whether implementation of an obesity intake protocol and electronic health record (EHR) form to guide behavior modification would facilitate identification and management of adult obesity in a Federally Qualified Health Center serving low-income, Hispanic patients. Materials and Methods In three studies, we examined clinician and patient outcomes before and after the addition of the weight management protocol and form. In the Clinician Study, 12 clinicians self-reported obesity management practices. In the Population Study, BMI and order data from 5000 patients and all 40 clinicians in the practice were extracted from the EHR preintervention and postintervention. In the Exposure Study, EHR-documented outcomes for a sub-sample of 46 patients actually exposed to the obesity management form were compared to matched controls. Results Clinicians reported that the intake protocol and form increased their performance of obesity-related assessments and their confidence in managing obesity. However, no improvement in obesity management practices or patient weight-loss was evident in EHR records for the overall clinic population. Further analysis revealed that only 55 patients were exposed to the form. Exposed patients were twice as likely to receive weight-loss counseling following the intervention, as compared to before, and more likely than matched controls. However, their obesity outcomes did not differ. Conclusion Results suggest that an obesity intake protocol and EHR-based weight management form may facilitate clinician weight-loss counseling among those exposed to the form. Significant implementation barriers can limit exposure, however, and need to be addressed. PMID:25665700

  11. Lean management in health care: definition, concepts, methodology and effects reported (systematic review protocol)

    PubMed Central

    2014-01-01

    Background Lean is a set of operating philosophies and methods that help create a maximum value for patients by reducing waste and waits. It emphasizes the consideration of the customer’s needs, employee involvement and continuous improvement. Research on the application and implementation of lean principles in health care has been limited. Methods This is a protocol for a systematic review, following the Cochrane Effective Practice and Organisation of Care (EPOC) methodology. The review aims to document, catalogue and synthesize the existing literature on the effects of lean implementation in health care settings especially the potential effects on professional practice and health care outcomes. We have developed a Medline keyword search strategy, and this focused strategy will be translated into other databases. All search strategies will be provided in the review. The method proposed by the Cochrane EPOC group regarding randomized study designs, non-randomised controlled trials controlled before and after studies and interrupted time series will be followed. In addition, we will also include cohort, case–control studies, and relevant non-comparative publications such as case reports. We will categorize and analyse the review findings according to the study design employed, the study quality (low- versus high-quality studies) and the reported types of implementation in the primary studies. We will present the results of studies in a tabular form. Discussion Overall, the systematic review aims to identify, assess and synthesize the evidence to underpin the implementation of lean activities in health care settings as defined in this protocol. As a result, the review will provide an evidence base for the effectiveness of lean and implementation methodologies reported in health care. Systematic review registration PROSPERO CRD42014008853 PMID:25238974

  12. Determining the impact of smoking point of sale legislation among youth (Display) study: a protocol for an evaluation of public health policy

    PubMed Central

    2014-01-01

    Background Tobacco advertising and product promotions have been largely banned in the UK but point of sale (POS) tobacco advertising is one of the few places where tobacco products may be legitimately advertised. POS displays have been shown to increase susceptibility to smoking, experimentation and initiation into smoking. These displays may also influence perceived prevalence of smoking and the perception that tobacco products are easily obtained and are a ‘normal’ product. A ban of POS tobacco advertising was introduced in Scotland in large tobacco retail outlets of over 280m2 internal sales floor areas (mainly supermarkets) in April 2013 and will be extended to include smaller tobacco retail outlets in April 2015. However, the impact of POS bans on smoking attitudes, behaviours and prevalence has yet to be determined. Methods/design This study has a multi-modal before and after design and uses mixed methods to collect data, at baseline and then with longitudinal follow-up for 4 years, in four purposively selected communities. For the purposes of the study, community is defined as the catchment areas of the secondary schools selected for study. There are four main components to the on-going study. In each of the four communities, at baseline and in follow-up years, there will be: mapping and spatial analyses of tobacco retail outlets; tobacco advertising and marketing audits of tobacco retail outlets most used by young people; cross-sectional school surveys of secondary school pupils; and focus group interviews with purposive samples of secondary school pupils. The tobacco audit is supplemented by interviews and observations conducted with a panel of tobacco retailers recruited from four matched communities. Discussion This study examines the impact of the implementation of both a partial and comprehensive ban on point of sale (POS) tobacco advertising on attitudes to smoking, brand awareness, perceived ease of access to tobacco products and youth smoking

  13. Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial

    PubMed Central

    Khan, Sameer; Rogers, Jason D; Otobo, Emamuzo; Patel, Nishant P; Ullman, Thomas; Colombel, Jean Fred; Moore, Shirley; Sands, Bruce E

    2015-01-01

    patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints. Conclusions HealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not. Trial Registration ClinicalTrials.gov NCT02322307; https://clinicaltrials.gov/ct2/show/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr). PMID:25693610

  14. Systematic review of the literature on the effectiveness of product reformulation measures to reduce the sugar content of food and drink on the population's sugar consumption and health: a study protocol

    PubMed Central

    Hashem, Kawther M; He, Feng J; MacGregor, Graham A

    2016-01-01

    Introduction Obesity, type 2 diabetes and dental caries are all major public health problems in the UK, with significant costs to the healthcare service. We aim to conduct a systematic review to summarise the evidence on the effectiveness of product reformulation measures to reduce the sugar content of food and drink on the population's sugar consumption and health. Methods and analysis Electronic database will be systematically searched using a combination of terms, tailored to optimise sensitivity, specificity, and the syntax and functionality of each database. The databases searched will include the Cochrane Library, EMBASE, MEDLINE (Ovid) and Scopus. The bibliographies of those papers that match inclusion criteria will be searched by hand to identify any further, relevant references, which will be subject to the same screening and selection process. The database search results will be supplemented by hand searches. In addition to the peer-reviewed literature, a number of grey literature searches will be undertaken using the broad search terms ‘sugar’ and ‘food’ or ‘drink’ and ‘reduction’, these searches will include key government and organisation websites as well as general searches in Google. The selection of the studies, data collection and quality appraisal will be performed independently by 2 reviewers. Data will be initially analysed through a narrative synthesis method. If a subset of data we analyse appears comparable, we will investigate the possibility of performing a meta-analysis. Ethics and dissemination Ethics approval will not be required as this is a protocol for a systematic review. The findings will be disseminated widely through conference presentations and published in a peer-reviewed journal. PROSPERO registration number CRD42016034022. PMID:27288379

  15. Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families?

    PubMed Central

    2014-01-01

    clinicians. Discussion This is the first study to compare the effectiveness of a PT program originally designed with and for parents from underserved racial and ethnic populations (CPP) against a well-established program considered to be the ‘the gold standard’ (PCIT) with a high-risk population of parents. Challenges related to conducting a randomized trial in a fee-for-service mental health clinic serving urban, low-income families are discussed. Trial registration NCT01517867 PMID:24581245

  16. Protocol: realist synthesis of the impact of unemployment insurance policies on poverty and health.

    PubMed

    Molnar, Agnes; O'Campo, Patricia; Ng, Edwin; Mitchell, Christiane; Muntaner, Carles; Renahy, Emilie; St John, Alexander; Shankardass, Ketan

    2015-02-01

    Unemployment insurance is an important social protection policy that buffers unemployed workers against poverty and poor health. Most unemployment insurance studies focus on whether increases in unemployment insurance generosity are predictive of poverty and health outcomes. Less work has used theory-driven approaches to understand and explain how and why unemployment insurance works, for whom, and under what circumstances. Given this, we present a realist synthesis protocol that seeks to unpack how contextual influences trigger relevant mechanisms to generate poverty and health outcomes. In this protocol, we conceptualize unemployment insurance as a key social protection policy; provide a supporting rationale on the need for a realist synthesis; and describe our process on identifying context-mechanism-outcome pattern configurations. Six methodological steps are described: initial theory development, search strategy; selection and appraisal of documents; data extraction; analysis and synthesis process; and presentation and dissemination of revised theory. Our forthcoming realist synthesis will be the first to build and test theory on the intended and unintended outcomes of unemployment insurance policies. Anticipated findings will allow policymakers to move beyond 'black box' approaches to consider 'mechanism-based' explanations that explicate the logic on how and why unemployment insurance matters. PMID:25265163

  17. Protocol: realist synthesis of the impact of unemployment insurance policies on poverty and health.

    PubMed

    Molnar, Agnes; O'Campo, Patricia; Ng, Edwin; Mitchell, Christiane; Muntaner, Carles; Renahy, Emilie; St John, Alexander; Shankardass, Ketan

    2015-02-01

    Unemployment insurance is an important social protection policy that buffers unemployed workers against poverty and poor health. Most unemployment insurance studies focus on whether increases in unemployment insurance generosity are predictive of poverty and health outcomes. Less work has used theory-driven approaches to understand and explain how and why unemployment insurance works, for whom, and under what circumstances. Given this, we present a realist synthesis protocol that seeks to unpack how contextual influences trigger relevant mechanisms to generate poverty and health outcomes. In this protocol, we conceptualize unemployment insurance as a key social protection policy; provide a supporting rationale on the need for a realist synthesis; and describe our process on identifying context-mechanism-outcome pattern configurations. Six methodological steps are described: initial theory development, search strategy; selection and appraisal of documents; data extraction; analysis and synthesis process; and presentation and dissemination of revised theory. Our forthcoming realist synthesis will be the first to build and test theory on the intended and unintended outcomes of unemployment insurance policies. Anticipated findings will allow policymakers to move beyond 'black box' approaches to consider 'mechanism-based' explanations that explicate the logic on how and why unemployment insurance matters.

  18. Canadian Study of Determinants of Endometabolic Health in ChIlDrEn (CanDECIDE study): a cohort study protocol examining the mechanisms of obesity in survivors of childhood brain tumours

    PubMed Central

    Samaan, M Constantine; Thabane, Lehana; Burrow, Sarah; Dillenburg, Rejane F; Scheinemann, Katrin

    2013-01-01

    Background Childhood obesity has reached epidemic proportions and is impacting children's health globally. In adults, obesity is associated with chronic low-grade inflammation that leads to insulin resistance, which is one of the important mechanisms through which dysregulation of metabolism occurs. There is limited information available about the contribution of inflammation to metabolic health in obese children, and how individual and lifestyle factors impact this risk. One of the paediatric groups at risk of higher rates of obesity includes the survivors of childhood brain tumours. The aim of this study was to evaluate the mechanisms that contribute to inflammation in obese survivors of childhood brain tumours. Methods and analysis This is a prospective cohort study. We will recruit lean and obese survivors of childhood brain tumours, and a control group composed of lean and obese children with no history of tumours. We will measure circulating and urinary cytokine levels and cytokine gene expression in monocytes. In addition, the methylation patterns of cytokine genes and that of toll-like receptor genes will be evaluated. These will be correlated with individual and lifestyle factors including age, sex, ethnicity, puberty, body mass index, fasting lipid levels, insulin sensitivity, diet, exercise, sleep, stress and built environment. The sample size calculation showed that we need 25 participants per arm Ethics and dissemination This study has received ethics approval from the institutional review board. Once completed, we will publish this work in peer-reviewed journals and share the findings in presentations and posters in meetings. Discussion This study will permit the interrogation of inflammation as a contributor to obesity and its complications in obese survivors of childhood brain tumours and compare them with lean survivors and lean and obese controls with no history of tumours, which may help identify therapeutic and preventative interventions to

  19. Intervention mapping: protocol for applying health psychology theory to prevention programmes.

    PubMed

    Kok, Gerjo; Schaalma, Herman; Ruiter, Robert A C; van Empelen, Pepijn; Brug, Johannes

    2004-01-01

    Evidence-based health promotion programmes are based on empirical data and theory. While a broad range of social and behavioural science theories are available, the actual application of these theories in programme design remains a real challenge for health promotion planners. Intervention Mapping describes a protocol for the development of theory- and evidence-based health promotion programmes. It provides guidelines and tools for the selection of theoretical foundations and underpinnings of health promotion programmes, for the application of theory, and for the translation of theory in actual programme materials and activities. This article presents the protocol and elaborates on the application of theory, using examples from successful intervention programmes.

  20. A study of treadmill exercise protocols for Chinese males.

    PubMed

    Ho, B L

    1982-02-01

    Treadmill stress testing currently is used in screening for coronary artery disease. Maximal oxygen consumption is the best index of work capacity and maximal cardiovascular function. Clinically, there are many exercise protocols being utilized, including Bruce, Kattus, Balke, Naughton, and Chinese Air Force (CAF). The purpose of this study is to compare five of them and evaluate their reproducibility. Each of 24 volunteers performed one exercise test per week for 3 periods totalling 15 weeks. During each period, the five different protocols were performed in individually randomized order. Maximal and submaximal oxygen consumption and heart rate were determined. Statistical analysis revealed no difference in maximal oxygen consumption among the various protocols; however significant differences did exist in maximal treadmill time. Maximal exertional duration was not affected by the test periods. All of the five protocols were equally reproducible. The Chinese Air Force has adopted a treadmill protocol with a constant speed of 3.5 mph and a 5% increase in elevation every 3 min. The physiological parameters measured by this protocol include a maximal heart rate of 181 beats/min; maximal oxygen consumption of 48 ml/kg/min; and maximal exercise duration of 17 min. Bruce and Balke protocols were 13 and 24 min, respectively, in our study. The regression equation of oxygen consumption and duration was: Y (ml/kg/min) = 1.26X (min) + 26.3. The CAF protocol is a safe, reproducible, easily performed method with moderate exercise duration. We confirm its advantages and prefer to select this protocol to serve as a routine screening or clinical method for use in testing Chinese people.

  1. Ascension health's demonstration of full disclosure protocol for unexpected events during labor and delivery shows promise.

    PubMed

    Hendrich, Ann; McCoy, Christine Kocot; Gale, Jane; Sparkman, Lora; Santos, Palmira

    2014-01-01

    Communicating openly and honestly with patients and families about unexpected medical events-a policy known as full disclosure-improves outcomes for patients and providers. Although many certification and licensing organizations have declared full disclosure to be imperative, the adoption of and adherence to a full disclosure protocol is not common practice in most clinical settings. We conducted a case study of Ascension Health's implementation of a full disclosure protocol at five labor and delivery demonstration sites. Twenty-seven months after implementation, the rate of full disclosure had increased by 221 percent. Practitioners saw insurers' acceptance of the full disclosure protocol, consistent and ongoing leadership by local practitioners and hospitals, the establishment of a well-trained local investigation and disclosure team, and disclosure training for practitioners as key catalysts for change. Lessons learned from this multisite initiative can inform liability insurers and guide providers who are committed to ensuring that full disclosure becomes the only response to unexpected medical events.

  2. Experimental protocols and preparations to study respiratory long term facilitation

    PubMed Central

    Mateika, Jason H.; Sandhu, Kulraj S.

    2011-01-01

    Respiratory long-term facilitation is a form of neuronal plasticity that is induced following exposure to intermittent hypoxia. Long-term facilitation is characterized by a progressive increase in respiratory motor output during normoxic periods that separate hypoxic episodes and by a sustained elevation in respiratory activity for up to 90 min after exposure to intermittent hypoxia. This phenomenon is associated with increases in phrenic, hypoglossal or carotid sinus nerve inspiratory-modulated discharge. The examination of long-term facilitation has been steadily ongoing for approximately 3 decades. During this period of time a variety of animal models (e.g. cats, rats and humans), experimental preparations and intermittent hypoxia protocols have been used to study long-term facilitation. This review is designed to summarize the strengths and weaknesses of the models, preparations and protocols that have been used to study LTF over the past 30 years. The review is divided into two primary sections. Initially, the models and protocols used to study LTF in animals other than humans will be discussed, followed by a section specifically focused on human studies. Each section will begin with a discussion of various factors that must be considered when selecting an experimental preparation and intermittent hypoxia protocol to examine LTF. Model and protocol design recommendations will follow, with the goal of presenting a prevailing model and protocol that will ultimately ensure standardized comparisons across studies. PMID:21292044

  3. Integrated care for frail elderly compared to usual care: a study protocol of a quasi-experiment on the effects on the frail elderly, their caregivers, health professionals and health care costs

    PubMed Central

    2013-01-01

    Background Frail elderly persons living at home are at risk for mental, psychological, and physical deterioration. These problems often remain undetected. If care is given, it lacks the quality and continuity required for their multiple and changing problems. The aim of this project is to improve the quality and efficacy of care given to frail elderly living independently by implementing and evaluating a preventive integrated care model for the frail elderly. Methods/design The design is quasi-experimental. Effects will be measured by conducting a before and after study with control group. The experimental group will consist of 220 elderly of 8 GPs (General Practitioners) who will provide care according to the integrated model (The Walcheren Integrated Care Model). The control group will consist of 220 elderly of 6 GPs who will give care as usual. The study will include an evaluation of process and outcome measures for the frail elderly, their caregivers and health professionals as well as a cost-effectiveness analysis. A concurrent mixed methods design will be used. The study population will consist of elderly 75 years or older who live independently and score a 4 or higher on the Groningen Frailty Indicator, their caregivers and health professionals. Data will be collected prospectively at three points in time: T0, T1 (3 months after inclusion), and T2 (12 months after inclusion). Similarities between the two groups and changes over time will be assessed with t-tests and chi-square tests. For each measure regression analyses will be performed with the T2-score as the dependent variable and the T0-score, the research group and demographic variables as independent variables. Discussion A potential obstacle for this study will be the willingness of the elderly and their caregivers to participate. To increase willingness, the request to participate will be sent via the elders’ own GP. Interviewers will be from their local region and gifts will be given. A

  4. Electronically delivered, multicomponent intervention to reduce unnecessary antibiotic prescribing for respiratory infections in primary care: a cluster randomised trial using electronic health records—REDUCE Trial study original protocol

    PubMed Central

    Juszczyk, Dorota; Charlton, Judith; McDermott, Lisa; Soames, Jamie; Sultana, Kirin; Ashworth, Mark; Fox, Robin; Hay, Alastair D; Little, Paul; Moore, Michael V; Yardley, Lucy; Prevost, A Toby; Gulliford, Martin C

    2016-01-01

    Introduction Respiratory tract infections (RTIs) account for about 60% of antibiotics prescribed in primary care. This study aims to test the effectiveness, in a cluster randomised controlled trial, of electronically delivered, multicomponent interventions to reduce unnecessary antibiotic prescribing when patients consult for RTIs in primary care. The research will specifically evaluate the effectiveness of feeding back electronic health records (EHRs) data to general practices. Methods and analysis 2-arm cluster randomised trial using the EHRs of the Clinical Practice Research Datalink (CPRD). General practices in England, Scotland, Wales and Northern Ireland are being recruited and the general population of all ages represents the target population. Control trial arm practices will continue with usual care. Practices in the intervention arm will receive complex multicomponent interventions, delivered remotely to information systems, including (1) feedback of each practice's antibiotic prescribing through monthly antibiotic prescribing reports estimated from CPRD data; (2) delivery of educational and decision support tools; (3) a webinar to explain and promote effective usage of the intervention. The intervention will continue for 12 months. Outcomes will be evaluated from CPRD EHRs. The primary outcome will be the number of antibiotic prescriptions for RTIs per 1000 patient years. Secondary outcomes will be: the RTI consultation rate; the proportion of consultations for RTI with an antibiotic prescribed; subgroups of age; different categories of RTI and quartiles of intervention usage. There will be more than 80% power to detect an absolute reduction in antibiotic prescription for RTI of 12 per 1000 registered patient years. Total healthcare usage will be estimated from CPRD data and compared between trial arms. Ethics and dissemination Trial protocol was approved by the National Research Ethics Service Committee (14/LO/1730). The pragmatic design of the trial

  5. See Me Smoke-Free: Protocol for a Research Study to Develop and Test the Feasibility of an mHealth App for Women to Address Smoking, Diet, and Physical Activity

    PubMed Central

    Johnson, Thienne; Gordon, Judith S

    2016-01-01

    Background This paper presents the protocol for an ongoing research study to develop and test the feasibility of a multi-behavioral mHealth app. Approximately 27 million women smoke in the US, and more than 180,000 women die of illnesses linked to smoking annually. Women report greater difficulties quitting smoking. Concerns about weight gain, negative body image, and low self-efficacy may be key factors affecting smoking cessation among women. Recent studies suggest that a multi-behavioral approach, including diet and physical activity, may be more effective at helping women quit. Guided imagery has been successfully used to address body image concerns and self-efficacy in our 3 target behaviors—exercise, diet and smoking cessation. However, it has not been used simultaneously for smoking, diet, and exercise behavior in a single intervention. While imagery is an effective therapeutic tool for behavior change, the mode of delivery has generally been in person, which limits reach. mHealth apps delivered via smart phones offer a unique channel through which to distribute imagery-based interventions. Objective The objective of our study is to evaluate the feasibility of an mHealth app for women designed to simultaneously address smoking, diet, and physical activity behaviors. The objectives are supported by three specific aims: (1) develop guided imagery content, user interface, and resources to reduce weight concern, and increase body image and self-efficacy for behavior change among women smokers, (2) program a prototype of the app that contains all the necessary elements of text, graphics, multimedia and interactive features, and (3) evaluate the feasibility, acceptability, and preliminary efficacy of the app with women smokers. Methods We created the program content and designed the prototype application for use on the Android platform in collaboration with 9 participants in multiple focus groups and in-depth interviews. We programmed and tested the application

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

    PubMed Central

    Hysong, Sylvia J; Sawhney, Mona K; Wilson, Lindsey; Sittig, Dean F; Esquivel, Adol; Watford, Monica; Davis, Traber; Espadas, Donna; Singh, Hardeep

    2009-01-01

    Background Health information technology and electronic medical records (EMRs) are potentially powerful systems-based interventions to facilitate diagnosis and treatment because they ensure the delivery of key new findings and other health related information to the practitioner. However, effective communication involves more than just information transfer; despite a state of the art EMR system, communication breakdowns can still occur. [1-3] In this project, we will adapt a model developed by the Systems Engineering Initiative for Patient Safety (SEIPS) to understand and improve the relationship between work systems and processes of care involved with electronic communication in EMRs. We plan to study three communication activities in the Veterans Health Administration's (VA) EMR: electronic communication of abnormal imaging and laboratory test results via automated notifications (i.e., alerts); electronic referral requests; and provider-to-pharmacy communication via computerized provider order entry (CPOE). Aim Our specific aim is to propose a protocol to evaluate the systems and processes affecting outcomes of electronic communication in the computerized patient record system (related to diagnostic test results, electronic referral requests, and CPOE prescriptions) using a human factors engineering approach, and hence guide the development of interventions for work system redesign. Design This research will consist of multiple qualitative methods of task analysis to identify potential sources of error related to diagnostic test result alerts, electronic referral requests, and CPOE; this will be followed by a series of focus groups to identify barriers, facilitators, and suggestions for improving the electronic communication system. Transcripts from all task analyses and focus groups will be analyzed using methods adapted from grounded theory and content analysis. PMID:19781075

  7. Epidemiology, health systems and stakeholders in rheumatic heart disease in Africa: a systematic review protocol

    PubMed Central

    Moloi, Annesinah Hlengiwe; Watkins, David; Engel, Mark E; Mall, Sumaya; Zühlke, Liesl

    2016-01-01

    Introduction Rheumatic heart disease (RHD) is a chronic disease affecting the heart valves, secondary to group A streptococcal infection (GAS) and subsequent acute rheumatic fever (ARF). However, RHD cure and preventative measures are inextricably linked with socioeconomic development, as the disease mainly affects children and young adults living in poverty. In order to address RHD, public health officials and health policymakers require up-to-date knowledge on the epidemiology of GAS, ARF and RHD, as well as the existing enablers and gaps in delivery of evidence-based care for these conditions. We propose to conduct a systematic review to assess the literature comprehensively, synthesising all existing quantitative and qualitative data relating to RHD in Africa. Methods and analysis We plan to conduct a comprehensive literature search using a number of databases and reference lists of relevant articles published from January 1995 to December 2015. Two evaluators will independently review and extract data from each article. Additionally, we will assess overall study quality and risk of bias, using the Newcastle-Ottawa Scale and the Critical Appraisal Skills Programme criteria for quantitative and qualitative studies, respectively. We will meta-analyse estimates of prevalence, incidence, case fatality and mortality for each of the conditions separately for each country. Qualitative meta-analysis will be conducted for facilitators and barriers in RHD health access. Lastly, we will create a list of key stakeholders. This protocol is registered in the PROSPERO International Prospective Register of systematic reviews, registration number CRD42016032852. Ethics and dissemination The information provided by this review will inform and assist relevant stakeholders in identifying key areas of intervention, and designing and implementing evidence-based programmes and policies at the local and regional level. With slight modifications (ie, to the country terms in the search

  8. IMMUNE RESPONSE OF SEVERE MALNUTRITION CHILDREN TREATED ACCORDING TO THE PROTOCOL OF THE WORLD HEALTH ORGANIZATION.

    PubMed

    Peixoto Paes-Silva, Rebecca; Correia de Macedo, Érika Michelle; Oliveira Tomiya, Marília Tokiko; Machado Barbosa de Castro, Célia Maria

    2015-08-01

    The aim of the study was to compare the innate immune system of severely malnourished children admitted to the Instituto de Medicina Integral Professor Fernando Figueira and treated according to the protocol of the World Health Organization (WHO) at admission and discharge. An experimental study was conducted with 20 children under two years of age. Ten of them had severe malnutrition and ten were a control group. The malnourished group consisted of hospitalized infants and it was submitted to WHO's protocol. Children with HIV and re-admitted during the study period were excluded. A blood sample was taken at admission and at discharge. Later, an analysis of blood leukocytes, adherence index, phagocytic capacity, production of free radicals superoxide and nitric oxide was performed. Patients with severe malnutrition at hospital discharge showed improved phagocytic function, release of oxygen radicals and reduction of the number of lymphocytes when compared to the time of admission. When compared to the control group, patients at hospital discharge had lower lymphocyte values and lower production of free radicals. Thus, it can be concluded that the duration of hospitalization was insufficient to restore cell-mediated immunity and microbicide activity.

  9. Pain education in pre-registration professional health courses: a protocol for a scoping review

    PubMed Central

    Thompson, Kate; Milligan, James; Johnson, Mark I; Briggs, Michelle

    2016-01-01

    Introduction Pain is a global health concern causing significant health and social problems with evidence that patients experiencing pain are receiving inadequate care. The content of pain education in pre-registration professional health courses is thought to be lacking both in the UK and internationally which is unacceptable considering the prevalence of pain. Evaluating the effect of education is complex in that the outcome (improved healthcare) is some distance from the educational approach. Best evidence medical education has been proposed as a continuum between ‘opinion-based teaching’ and ‘evidence-based teaching’. Searching for evidence to inform best practice in health education is complex. A scoping review provides a practical and comprehensive strategy to locate and synthesise literature of varied methodology including reports from a variety of sources. The aim of this article is to describe a protocol for a scoping review that will locate, map and report research, guidelines and policies for pain education in pre-registration professional health courses. The extent, range and nature of reports will be examined, and where possible titles for potential systematic review will be identified. Methods and analysis Reports will be included for review that are directly relevant to the development of the pain curriculum in pre-registration professional health courses, eg nursing, medicine, physiotherapy. The search strategy will identify reports that include [pain] AND [pre-registration education or curriculum] AND [health professionals] in the title or abstract. Two authors will independently screen retrieved studies against eligibility criteria. A numerical analysis regarding the extent, nature and distribution of reports will be given along with a narrative synthesis to describe characteristics of relevant reports. Ethics and dissemination Formal ethical approval was not required to undertake this scoping review. Findings will be published in

  10. Standardisation of Study Protocols - Pros and Cons.

    PubMed

    D'Haens, Geert

    2016-09-01

    Designing clinical trials in inflammatory bowel diseases is challenging. Composite scores that have been used for drug approval until recently such as the Crohn's disease activity index (CDAI) and the Mayo score for ulcerative colitis have been criticized by regulatory bodies for its lack of validation, poor correlation with objective mucosal disease and absence of 'patient reported outcomes'.Most drug development programs use the 'classic 'separation' between an induction and a maintenance phase. Challenging issues are the 'ideal timing' of the primary endpoint for induction and maintenance studies, strategies to reduce placebo response rates and rules for corticosteroids withdrawal. Discussion about which patients to re-randomize after induction into the maintenance phase of the study is critical.Presently, new instruments for disease assessment in IBD are being developed and validated. Central (independent) review of endoscopic recordings at screening and at the end of the intervention will probably become standard. Finally, the most optimal trial design for every individual intervention is likely to depend on the mechanism of action of the medication under study. PMID:27604980

  11. Individual empowerment in overweight and obese patients: a study protocol

    PubMed Central

    Struzzo, Pierluigi; Fumato, Raffaella; Tillati, Silvia; Cacitti, Anita; Gangi, Fabrizio; Stefani, Alessia; Torcutti, Alessia; Crapesi, Lucia; Tubaro, Gianni; Balestrieri, Matteo

    2013-01-01

    Introduction Obesity is a growing health problem in Europe and it causes many diseases. Many weight-reducing methods are reported in medical literature, but none of them proved to be effective in maintaining the results achieved over time. Self-empowerment can be an important innovative method, but an effectiveness study is necessary. In order to standardise the procedures for a randomised controlled study, a pilot study will be run to observe, measure and evaluate the effects of a period of self-empowerment group treatment on overweight/obese patients. Methods and analysis Non-controlled, experimental, pilot study. A selected group of patients with body mass index >25, with no severe psychiatric disorders, with no aesthetic or therapeutic motivation will be included in the study. A set of quantitative and qualitative measures will be utilised to evaluate the effects of a self-empowerment course in a 12 month time. Group therapy and medical examinations will also complete this observational phase. At the end of this pilot study, a set of appropriate measures and procedures to determine the effectiveness of individual empowerment will be identified and agreed among the different professional figures. Results will be recorded and analysed to start a randomised controlled trial to evaluate the effectiveness of the proposed methodology. Ethics and dissemination This protocol was approved by the local Ethics Committee of Udine in March 2012. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and public events involving the local administrations of the towns where the trial participants are resident. Trial Registration http://www.clinicalstrials.gov identifier NCT01644708. PMID:23676799

  12. Health, economic, psychological and social impact of educating carers of patients with advanced pulmonary disease (protocol).

    PubMed

    Sladek, R M; Jones, T; Phillips, P A; Luszcz, M; Rowett, D; Eckermann, S; Woodman, R J; Frith, P

    2011-09-01

    People with advanced pulmonary disease (APD), such as those with chronic obstructive pulmonary disease, have markedly impaired quality of life. Home Oxygen Therapy (HOT) itself is burdensome, although it often improves survival duration and quality of life in these patients. The exact burdens on informal caregivers of these patients are unknown. The central purpose of the pragmatic randomized controlled study described in this protocol is to determine the effectiveness of improving the skills and knowledge of carers of patients with APD who use HOT. Specifically we aimed to estimate the incremental impact of this carer intervention above usual care on health, economic, psychological and social domains for patient and carer dyads relative to the level of current burden. Eligible patients and their carers were recruited through three major hospitals, and randomized to an intervention or control group. The carers in the intervention group received two home-delivered education sessions based on the principles of academic detailing. Participants are currently being followed over 12 months. The primary outcome will be the proportion of patients surviving without a chronic obstructive pulmonary disease-related readmission / residential (non respite) care over 12 months. Carer secondary outcomes include perceived caregiver burden, level of expected and received social support, perceived level of mastery, self esteem, health related quality of life and disability, and ability to conduct domestic chores and household maintenance, social activities and provide service to others, and fatigue. Secondary patient outcomes include health related quality of life and disability, and current respiratory health status.

  13. Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: Protocol for a Randomized Study Funded by the US Department of Veterans Affairs Health Services Research and Development Program

    PubMed Central

    Krein, Sarah L; Striplin, Dana; Marinec, Nicolle; Kerns, Robert D; Farris, Karen B; Singh, Satinder; An, Lawrence; Heapy, Alicia A

    2016-01-01

    pedometer-measured step counts, CBT skill practice, and physical functioning. Outcomes will be measured at 3 and 6 months post recruitment and will include pain-related interference, treatment satisfaction, and treatment dropout. Our primary hypothesis is that AI-CBT will result in pain-related functional outcomes that are at least as good as the standard approach, and that by scaling back the intensity of contact that is not associated with additional gains in pain control, the AI-CBT approach will be significantly less costly in terms of therapy time. Results The trial is currently in the start-up phase. Patient enrollment will begin in the fall of 2016 and results of the trial will be available in the winter of 2019. Conclusions This study will evaluate an intervention that increases patients’ access to effective CBT pain management services while allowing health systems to maximize program expansion given constrained resources. PMID:27056770

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

    NASA Astrophysics Data System (ADS)

    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.

  15. Mapping the progress and impacts of public health approaches to palliative care: a scoping review protocol

    PubMed Central

    Archibald, Daryll; Patterson, Rebecca; Haraldsdottir, Erna; Hazelwood, Mark; Fife, Shirley; Murray, Scott A

    2016-01-01

    Introduction Public health palliative care is a term that can be used to encompass a variety of approaches that involve working with communities to improve people's experience of death, dying and bereavement. Recently, public health palliative care approaches have gained recognition and momentum within UK health policy and palliative care services. There is general consensus that public health palliative care approaches can complement and go beyond the scope of formal service models of palliative care. However, there is no clarity about how these approaches can be undertaken in practice or how evidence can be gathered relating to their effectiveness. Here we outline a scoping review protocol that will systematically map and categorise the variety of activities and programmes that could be classified under the umbrella term ‘public health palliative care’ and highlight the impact of these activities where measured. Methods and analysis This review will be guided by Arksey and O'Malley's scoping review methodology and incorporate insights from more recent innovations in scoping review methodology. Sensitive searches of 9 electronic databases from 1999 to 2016 will be supplemented by grey literature searches. Eligible studies will be screened independently by two reviewers using a data charting tool developed for this scoping review. Ethics and dissemination This scoping review will undertake a secondary analysis of data already collected and does not require ethical approval. The results will facilitate better understanding of the practical application of public health approaches to palliative care, the impacts these activities can have and how to build the evidence base for this work in future. The results will be disseminated through traditional academic routes such as conferences and journals and also policy and third sector seminars. PMID:27417201

  16. Computer-Tutors and a Freshman Writer: A Protocol Study.

    ERIC Educational Resources Information Center

    Strickland, James

    Although there are many retrospective accounts from teachers and professional writers concerning the effect of computers on their writing, there are few real-time accounts of students struggling to simultaneously develop as writers and cope with computers. To fill this void in "testimonial data," a study examining talking-aloud protocols from a…

  17. What factors contribute to positive early childhood health and development in Australian Aboriginal children? Protocol for a population-based cohort study using linked administrative data (The Seeding Success Study)

    PubMed Central

    Falster, Kathleen; Jorm, Louisa; Eades, Sandra; Lynch, John; Banks, Emily; Brownell, Marni; Craven, Rhonda; Einarsdóttir, Kristjana; Randall, Deborah

    2015-01-01

    Introduction Australian Aboriginal children are more likely than non-Aboriginal children to have developmental vulnerability at school entry that tracks through to poorer literacy and numeracy outcomes and multiple social and health disadvantages in later life. Empirical evidence identifying the key drivers of positive early childhood development in Aboriginal children, and supportive features of local communities and early childhood service provision, are lacking. Methods and analysis The study population will be identified via linkage of Australian Early Development Census data to perinatal and birth registration data sets. It will include an almost complete population of children who started their first year of full-time school in New South Wales (NSW), Australia, in 2009 and 2012. Early childhood health and development trajectories for these children will be constructed via linkage to a range of administrative data sets relating to birth outcomes, congenital conditions, hospital admissions, emergency department presentations, receipt of ambulatory mental healthcare services, use of general practitioner services, contact with child protection and out-of-home care services, receipt of income assistance and fact of death. Using multilevel modelling techniques, we will quantify the contributions of individual-level and area-level factors to variation in early childhood development outcomes in Aboriginal and non-Aboriginal children. Additionally, we will evaluate the impact of two government programmes that aim to address early childhood disadvantage, the NSW Aboriginal Maternal and Infant Health Service and the Brighter Futures Program. These evaluations will use propensity score matching methods and multilevel modelling. Ethics and dissemination Ethical approval has been obtained for this study. Dissemination mechanisms include engagement of stakeholders (including representatives from Aboriginal community controlled organisations, policy agencies, service

  18. Feasibility of Automatic Extraction of Electronic Health Data to Evaluate a Status Epilepticus Clinical Protocol.

    PubMed

    Hafeez, Baria; Paolicchi, Juliann; Pon, Steven; Howell, Joy D; Grinspan, Zachary M

    2016-05-01

    Status epilepticus is a common neurologic emergency in children. Pediatric medical centers often develop protocols to standardize care. Widespread adoption of electronic health records by hospitals affords the opportunity for clinicians to rapidly, and electronically evaluate protocol adherence. We reviewed the clinical data of a small sample of 7 children with status epilepticus, in order to (1) qualitatively determine the feasibility of automated data extraction and (2) demonstrate a timeline-style visualization of each patient's first 24 hours of care. Qualitatively, our observations indicate that most clinical data are well labeled in structured fields within the electronic health record, though some important information, particularly electroencephalography (EEG) data, may require manual abstraction. We conclude that a visualization that clarifies a patient's clinical course can be automatically created using the patient's electronic clinical data, supplemented with some manually abstracted data. Future work could use this timeline to evaluate adherence to status epilepticus clinical protocols.

  19. Exploring why quality circles work in primary health care: a realist review protocol

    PubMed Central

    2013-01-01

    Background Quality circles (QCs) are commonly used in primary health care in Europe to consider and improve standard practice over time. They represent a complex social intervention that occurs within the fast-changing system of primary health care. Numerous controlled trials, reviews, and studies have shown small but unpredictable positive effect sizes on behavior change. Although QCs seem to be effective, stakeholders have difficulty understanding how the results are achieved and in generalizing the results with confidence. They also lack understanding of the active components of QCs which result in changes in the behavior of health care professionals. This protocol for a realist synthesis will examine how configurations of components and the contextual features of QCs influence their performance. Methods/Design Stakeholder interviews and a scoping search revealed the processes of QCs and helped to describe their core components and underlying theories. After clarifying their historical and geographical distribution, a purposive and systematic search was developed to identify relevant papers to answer the research questions, which are: understanding why, how, and when QCs work, over what time frame, and in what circumstances. After selecting and abstracting appropriate data, configurations of contexts and mechanisms which influence the outcome of QCs within each study will be identified. Studies will be grouped by similar propositional statements in order to identify patterns and validation from stakeholders sought. Finally, theories will be explored in order to explain these patterns and to help stakeholders maintain and improve QC performance. Discussion Analyzing context-mechanism-outcome (CMO) patterns will reveal how QCs work and how contextual factors interact to influence their outcome. The aim is to investigate unique configurations that enable them to improve the performance of health care professionals. Using a standardized reporting system, this

  20. Effects of Charitable Versus Monetary Incentives on the Acceptance of and Adherence to a Pedometer-Based Health Intervention: Study Protocol and Baseline Characteristics of a Cluster-Randomized Controlled Trial

    PubMed Central

    Kramer, Jan-Niklas; Kehr, Flavius; Wahle, Fabian; Elser, Niklas; Fleisch, Elgar

    2016-01-01

    Background Research has so far benefited from the use of pedometers in physical activity interventions. However, when public health institutions (eg, insurance companies) implement pedometer-based interventions in practice, people may refrain from participating due to privacy concerns. This might greatly limit the applicability of such interventions. Financial incentives have been successfully used to influence both health behavior and privacy concerns, and may thus have a beneficial effect on the acceptance of pedometer-based interventions. Objective This paper presents the design and baseline characteristics of a cluster-randomized controlled trial that seeks to examine the effect of financial incentives on the acceptance of and adherence to a pedometer-based physical activity intervention offered by a health insurance company. Methods More than 18,000 customers of a large Swiss health insurance company were allocated to a financial incentive, a charitable incentive, or a control group and invited to participate in a health prevention program. Participants used a pedometer to track their daily physical activity over the course of 6 months. A Web-based questionnaire was administered at the beginning and at the end of the intervention and additional data was provided by the insurance company. The primary outcome of the study will be the participation rate, secondary outcomes will be adherence to the prevention program, physical activity, and health status of the participants among others. Results Baseline characteristics indicate that residence of participants, baseline physical activity, and subjective health should be used as covariates in the statistical analysis of the secondary outcomes of the study. Conclusions This is the first study in western cultures testing the effectiveness of financial incentives with regard to a pedometer-based health intervention offered by a large health insurer to their customers. Given that the incentives prove to be effective

  1. The Effect of Health Information Technology on Health Care Provider Communication: A Mixed-Method Protocol

    PubMed Central

    Adler-Milstein, Julia; Harrod, Molly; Sales, Anne; Hofer, Timothy P; Saint, Sanjay; Krein, Sarah L

    2015-01-01

    Background Communication failures between physicians and nurses are one of the most common causes of adverse events for hospitalized patients, as well as a major root cause of all sentinel events. Communication technology (ie, the electronic medical record, computerized provider order entry, email, and pagers), which is a component of health information technology (HIT), may help reduce some communication failures but increase others because of an inadequate understanding of how communication technology is used. Increasing use of health information and communication technologies is likely to affect communication between nurses and physicians. Objective The purpose of this study is to describe, in detail, how health information and communication technologies facilitate or hinder communication between nurses and physicians with the ultimate goal of identifying how we can optimize the use of these technologies to support effective communication. Effective communication is the process of developing shared understanding between communicators by establishing, testing, and maintaining relationships. Our theoretical model, based in communication and sociology theories, describes how health information and communication technologies affect communication through communication practices (ie, use of rich media; the location and availability of computers) and work relationships (ie, hierarchies and team stability). Therefore we seek to (1) identify the range of health information and communication technologies used in a national sample of medical-surgical acute care units, (2) describe communication practices and work relationships that may be influenced by health information and communication technologies in these same settings, and (3) explore how differences in health information and communication technologies, communication practices, and work relationships between physicians and nurses influence communication. Methods This 4-year study uses a sequential mixed

  2. Using electronic wristbands and a triage protocol to protect mental health patients in the emergency department.

    PubMed

    Macy, Deborah; Johnston, Michelle

    2007-01-01

    In the emergency department of Mercy Hospital, concerns about possible elopement of mental health patients led to the use of the services of security officers, who were called for an average of 40 patient watches per week. Modified electronic wristbands, paired with a triage protocol, have significantly decreased the need for patient watches and decreased security costs.

  3. A protocol for the health and fitness assessment of NBA players.

    PubMed

    Scheller, A; Rask, B

    1993-04-01

    The assessment of the health and fitness of elite basketball players should be a multidisciplinary process. We have described an organized, efficient, and comprehensive protocol for preseason physical evaluations that could be used at the university as well as professional level.

  4. An institutional ethnography inquiry of health care work in special education: a research protocol

    PubMed Central

    Ng, Stella; Stooke, Rosamund; Regan, Sandra; Hibbert, Kathryn; Schryer, Catherine; Phelan, Shanon; Lingard, Lorelei

    2013-01-01

    Background Special education for children with chronic health conditions or disabilities requires the integration of health care work with education. This phenomenon occurs in an understudied and challenging context for integrated care despite policies and protocols that outline work processes in this context. We are interested in an approach to inquiry that will allow us to address gaps in current literature and practices in integrated care, and move towards informing policy. Study design and data collection methods Institutional ethnography is an approach to inquiry that maps the actualities of what individuals do at an everyday local level, while examining this work activity in relation to the sociopolitical context. It has been used to change policy and local practice by highlighting disjunctures between policy and actuality. We are adopting institutional ethnography and its three common methods of data collection: document collection, interviews, and observation/shadowing. Informants to this inquiry are chosen from school-based teams, family-centred units and constellations of clinical professionals. Methods of analysis We are following work processes, verbally and visually mapping what is done and by whom. It is important to note that work includes ‘unofficial’ work, including the work of families and others who may not be assigned an official work role in a policy or protocol. The mediating role of texts in work processes is also being mapped in order to link the local work to the high-level social coordinators. To begin, analysis focuses on local, or micro-level, work processes; next, analysis identifies and explains the macro-level coordination of the local work (i.e. social and political structures). Conclusion A primary outcome of this study will be the creation of verbal and visual maps that demonstrate the social organisation of work processes occurring in the health care-special education interface. These maps will make invisible work visible

  5. Health education interventions to raise awareness of rheumatic fever: a systematic review protocol

    PubMed Central

    2013-01-01

    Background There is a significant global health burden associated with acute rheumatic fever (ARF) and rheumatic heart disease (RHD), especially in developing countries. ARF and RHD most often strike children and young adults living in impoverished settings, where unhygienic conditions and lack of awareness and knowledge of streptococcal infection progression are common. Secondary prophylactic measures have been recommended in the past, but primary prevention measures have been gaining more attention from researchers frustrated by the perpetual prevalence of ARF and RHD in developing countries. Health education aims to empower people to take responsibility for their own well-being by gaining control over the underlying factors that influence health. We therefore conducted a review of the current best evidence for the use of health education interventions to increase awareness and knowledge of streptococcal pharyngitis and ARF. Methods and design This article describes the protocol for a systematic review of the effectiveness of health education interventions aimed at increasing awareness and knowledge of the symptoms, causes and consequences of streptococcal pharyngitis, rheumatic fever and/or rheumatic heart disease. Studies will be selected in which the effect of an intervention is compared with either a pre-intervention or a control, targeting all possible audience types. Primary and secondary outcomes of interest are pre-specified. Randomized controlled trials, quasi-randomized trials, controlled before–after studies and controlled clinical trials will be considered. We will search several bibliographic databases (for example, PubMed, EMBASE, World Health Organization Library databases, Google Scholar) and search sources for gray literature. We will meta-analyze included studies. We will conduct subgroup analyses according to intervention subtypes: printed versus audiovisual and mass media versus training workshops. Discussion This review will provide

  6. Adherence to oral anticoagulants in patients with atrial fibrillation—a population-based retrospective cohort study linking health information systems in the Valencia region, Spain: a study protocol

    PubMed Central

    Sanfélix-Gimeno, G; Rodríguez-Bernal, C L; Hurtado, I; Baixáuli-Pérez, C; Librero, J; Peiró, S

    2015-01-01

    Introduction Adherence to oral anticoagulation (OAC) treatment, vitamin K antagonists or new oral anticoagulants, is an essential element for effectiveness. Information on adherence to OAC in atrial fibrillation (AF) and the impact of adherence on clinical outcomes using real-world data barely exists. We aim to describe the patterns of adherence to OAC over time in patients with AF, estimate the associated factors and their impact on clinical events, and assess the same issues with conventional measures of primary and secondary adherence—proportion of days covered (PDC) and persistence—in routine clinical practice. Methods and analysis This is a population-based retrospective cohort study including all patients with AF treated with OAC from 2010 to date in Valencia, Spain; data will be obtained from diverse electronic records of the Valencia Health Agency. Primary outcome measure: adherence trajectories. Secondary outcomes: (1) primary non-adherence; (2) secondary adherence: (a) PDC, (b) persistence. Clinical outcomes: hospitalisation for haemorrhagic or thromboembolic events and death during follow-up. Analysis: (1) description of baseline characteristics, adherence patterns (trajectory models or latent class growth analysis models) and conventional adherence measures; (2) logistic or Cox multivariate regression models, to assess the associations between adherence measures and the covariates, and logistic multinomial regression models, to identify characteristics associated with each trajectory; (3) Cox proportional hazard models, to assess the relationship between adherence and clinical outcomes, with propensity score adjustment applied to further control for potential confounders; (4) to estimate the importance of different healthcare levels in the variations of adherence, logistic or Cox multilevel regression models. Ethics and dissemination This study has been approved by the corresponding Clinical Research Ethics Committee. We plan to disseminate the

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

    PubMed Central

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

    2016-01-01

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

  8. Cross-Sectional Study of 24-Hour Urinary Electrolyte Excretion and Associated Health Outcomes in a Convenience Sample of Australian Primary Schoolchildren: The Salt and Other Nutrients in Children (SONIC) Study Protocol

    PubMed Central

    Baxter, Janet R; Campbell, Karen J; Riddell, Lynn J; Rigo, Manuela; Liem, Djin Gie; Keast, Russell S; He, Feng J; Nowson, Caryl A

    2015-01-01

    Background Dietary sodium and potassium are involved in the pathogenesis of cardiovascular disease. Data exploring the cardiovascular outcomes associated with these electrolytes within Australian children is sparse. Furthermore, an objective measure of sodium and potassium intake within this group is lacking. Objective The primary aim of the Salt and Other Nutrient Intakes in Children (“SONIC”) study was to measure sodium and potassium intakes in a sample of primary schoolchildren located in Victoria, Australia, using 24-hour urine collections. Secondary aims were to identify the dietary sources of sodium and potassium, examine the association between these electrolytes and cardiovascular risk factors, and assess children’s taste preferences and saltiness perception of manufactured foods. Methods A cross-sectional study was conducted in a convenience sample of schoolchildren attending primary schools in Victoria, Australia. Participants completed one 24-hour urine collection, which was analyzed for sodium, potassium, and creatinine. Completeness of collections was assessed using collection time, total volume, and urinary creatinine. One 24-hour dietary recall was completed to assess dietary intake. Other data collected included blood pressure, body weight, height, waist and hip circumference. Children were also presented with high and low sodium variants of food products and asked to discriminate salt level and choose their preferred variant. Parents provided demographic information and information on use of discretionary salt. Descriptive statistics will be used to describe sodium and potassium intakes. Linear and logistic regression models with clustered robust standard errors will be used to assess the association between electrolyte intake and health outcomes (blood pressure and body mass index/BMI z-score and waist circumference) and to assess differences in taste preference and discrimination between high and low sodium foods, and correlations between

  9. Investigating the cost-effectiveness of health information technologies: a systematic review protocol

    PubMed Central

    Sheikh, Aziz; Nurmatov, Ulugbek B; Cresswell, Kathrin; Bates, David

    2013-01-01

    Introduction There is a need to develop new, more cost-effective models of healthcare and in this vein there is a considerable international interest in exploiting the potential offered by major developments in health information technologies (HITs). Very substantial investments are, as a result, now being made globally, but these still probably only represent a fraction of the investments needed if healthcare is to make the transition from the paper to the digital era. Investing greater resources is, however, inherently challenging and unpopular at a time of financial austerity and this is furthermore complicated by the thus far variable evidence of health benefits and demonstrable short-term to medium-term returns associated with investments in HITs. Objectives Building on our related systematic overviews investigating the impact of HITs, we now seek to estimate the cost-effectiveness of HITs and as a secondary aim to identify potentially transferable lessons in relation to how to realise returns on investments in these technologies. Methods We will conduct a systematic review to identify the empirical evidence base surrounding the return on investments from implementing HITs. Two reviewers will independently search major international databases for published, unpublished and on-going experimental and quasi-experimental studies of interest published during the period 1990–2013. These searches of bibliographic databases will be supplemented by contacting an international panel of experts. There will be no restriction on the language of publication of studies. Studies will be critically appraised using the Critical Appraisal Skills Programme (CASP) Economic Evaluations checklist. In view of the anticipated heterogeneity in intervention investigated, study design and health system contexts, we will undertake a descriptive, narrative and interpretative synthesis of data. Ethics and dissemination Ethical approval is not required. Results These will be presented in

  10. Analysis of energy efficient routing protocols for implementation of a ubiquitous health system

    NASA Astrophysics Data System (ADS)

    Kwon, Jongwon; Park, Yongman; Koo, Sangjun; Ayurzana, Odgeral; Kim, Hiesik

    2007-12-01

    The innovative Ubiquitous-Health was born through convergence of medical service, with development of up to date information technologies and ubiquitous IT. The U-Health can be applied to a variety of special situations for managing functions of each medical center efficiently. This paper focuses on estimation of various routing protocols for implementation of U-health monitoring system. In order to facilitate wireless communication over the network, a routing protocol on the network layer is used to establish precise and efficient route between sensor nodes so that information acquired from sensors may be delivered in a timely manner. A route establishment should be considered to minimize overhead, data loss and power consumption because wireless networks for U-health are organized by a large number of sensor nodes which are small in size and have limited processing power, memory and battery life. In this paper a overview of wireless sensor network technologies commonly known is described as well as evaluation of three multi hop routing protocols which are flooding, gossiping and modified low energy adaptive clustering hierarchy(LEACH) for use with these networks using TOSSIM simulator. As a result of evaluation the integrated wireless sensor board was developed in particular. The board is embedded device based on AVR128 porting TinyOS. Also it employs bio sensor measures blood pressure, pulse frequency and ZigBee module for wireless communication. This paper accelerates the digital convergence age through continual research and development of technologies related the U-Health.

  11. Social Media for e-Government in the Public Health Sector: Protocol for a Systematic Review

    PubMed Central

    Franco, Massimo; Tursunbayeva, Aizhan

    2016-01-01

    Background Public sector organizations worldwide are engaging with social media as part of a growing e-government agenda. These include government departments of health, public health agencies, and state-funded health care and research organizations. Although examples of social media in health have been described in the literature, little is known about their overall scope or how they are achieving the objectives of e-government. A systematic literature review is underway to capture and synthesize existing evidence on the adoption, use, and impacts of social media in the public health sector. A series of parallel scoping exercises has taken place to examine (1) relevant existing systematic reviews, to assess their focus, breadth, and fit with our review topic, (2) existing concepts related to e-government, public health, and the public health sector, to assess how semantic complexity might influence the review process, and (3) the results of pilot searches, to examine the fit of social media within the e-government and health literatures. The methods and observations of the scoping exercises are reported in this protocol, alongside the methods and interim results for the systematic review itself. Objective The systematic review has three main objectives: To capture the corpus of published studies on the uses of social media by public health organizations; to classify the objectives for which social media have been deployed in these contexts and the methods used; and to analyze and synthesize evidence of the uptake, use, and impacts of social media on various outcomes. Methods A set of scoping exercises were undertaken, to inform the search strategy and analytic framework. Searches have been carried out in MEDLINE, the Cochrane Library, Web of Science, and the Scopus international electronic databases, and appropriate gray literature sources. Articles published between January 1, 2004, and July 12, 2015, were included. There was no restriction by language. One

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

    PubMed

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

    2012-01-01

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

  13. The effectiveness of medical assistant health coaching for low-income patients with uncontrolled diabetes, hypertension, and hyperlipidemia: protocol for a randomized controlled trial and baseline characteristics of the study population

    PubMed Central

    2013-01-01

    Background Many patients with chronic disease do not reach goals for management of their conditions. Self-management support provided by medical assistant health coaches within the clinical setting may help to improve clinical outcomes, but most studies to date lack statistical power or methodological rigor. Barriers to large scale implementation of the medical assistant coach model include lack of clinician buy-in and the absence of a business model that will make medical assistant health coaching sustainable. This study will add to the evidence base by determining the effectiveness of health coaching by medical assistants on clinical outcomes and patient self-management, by assessing the impact of health coaching on the clinician experience, and by examining the costs and potential savings of health coaching. Methods/Design This randomized controlled trial will evaluate the effectiveness of clinic-based medical assistant health coaches to improve clinical outcomes and self-management skills among low-income patients with uncontrolled type 2 diabetes, hypertension, or hyperlipidemia. A total of 441 patients from two San Francisco primary care clinics have been enrolled and randomized to receive a health coach (n = 224) or usual care (n = 217). Patients participating in the health coaching group will receive coaching for 12 months from medical assistants trained as health coaches. The primary outcome is a change in hemoglobin A1c, systolic blood pressure, or LDL cholesterol among patients with uncontrolled diabetes, hypertension and hyperlipidemia, respectively. Self-management behaviors, perceptions of the health care team and clinician, BMI, and chronic disease self-efficacy will be measured at baseline and after 12 months. Clinician experience is being assessed through surveys and qualitative interviews. Cost and utilization data will be analyzed through cost-predictive models. Discussion Medical assistants are an untapped resource to provide self

  14. [Climatic change and public health: scenarios after the coming into force of the Kyoto Protocol].

    PubMed

    Ballester, Ferran; Díaz, Julio; Moreno, José Manuel

    2006-03-01

    According to the reports of the intergovernmental panel for climatic change (IPCC) human beings of the present and near future are going to experiment, in fact we are already experimenting, important changes in the world climate. Conscious of the magnitude of the problem, international organizations have taken a series of initiatives headed to stop the climatic change and to reduce its impact. This willingness has been shaped into the agreements established in the Kyoto protocol, where countries commit to reduce greenhouse-effect gas emissions. Kyoto protocol has come into force on February 16th 2005 with the support of 141 signing countries. Among the major worries are the effects which climatic change may have upon health, such as: 1) changes in the morbidity- mortality related to temperature; 2) Effects on health related with extreme meteorological events (tornados, storms, hurricanes and extreme raining); 3) Air pollution and increase of associated health effects; d) Diseases transmitted by food and water and 4) Infectious diseases transmitted by vectors and by rodents. Even if all the countries in the world committed to the Kyoto Protocol, some consequences of the climatic change will be inevitable; among them some will have a negative impact on health. It would be necessary to adapt a key response strategy to minimize the impacts of climatic change and to reduce, at minimum cost, its adverse effects on health. From the Public Health position, a relevant role can and must be played concerning the understanding of the risks for health of such climatic changes, the design of surveillance systems to evaluate possible impacts, and the establishment of systems to prevent or reduce damages as well as the identification and development of investigation needs. PMID:16539979

  15. [Climatic change and public health: scenarios after the coming into force of the Kyoto Protocol].

    PubMed

    Ballester, Ferran; Díaz, Julio; Moreno, José Manuel

    2006-03-01

    According to the reports of the intergovernmental panel for climatic change (IPCC) human beings of the present and near future are going to experiment, in fact we are already experimenting, important changes in the world climate. Conscious of the magnitude of the problem, international organizations have taken a series of initiatives headed to stop the climatic change and to reduce its impact. This willingness has been shaped into the agreements established in the Kyoto protocol, where countries commit to reduce greenhouse-effect gas emissions. Kyoto protocol has come into force on February 16th 2005 with the support of 141 signing countries. Among the major worries are the effects which climatic change may have upon health, such as: 1) changes in the morbidity- mortality related to temperature; 2) Effects on health related with extreme meteorological events (tornados, storms, hurricanes and extreme raining); 3) Air pollution and increase of associated health effects; d) Diseases transmitted by food and water and 4) Infectious diseases transmitted by vectors and by rodents. Even if all the countries in the world committed to the Kyoto Protocol, some consequences of the climatic change will be inevitable; among them some will have a negative impact on health. It would be necessary to adapt a key response strategy to minimize the impacts of climatic change and to reduce, at minimum cost, its adverse effects on health. From the Public Health position, a relevant role can and must be played concerning the understanding of the risks for health of such climatic changes, the design of surveillance systems to evaluate possible impacts, and the establishment of systems to prevent or reduce damages as well as the identification and development of investigation needs.

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

    PubMed

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

    2013-01-01

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

  17. [Protocol for complementary and alternative medicine within the Dutch mental health services].

    PubMed

    Hoenders, H J R; Appelo, M T; van den Brink, H; Hartogs, B M A; Berger, C J J

    2010-01-01

    Complementary and alternative medicine (CAM) is the subject of heated debate. There are many prejudices for and against CAM. At the centre for Integrative Psychiatry (CIP) of Lentis CAM is offered alongside conventional treatments, but under strict conditions. Because of the controversy surrounding CAM and the potential health risks involved, the CIP in Lentis has formulated a protocol for CAM which is presented in this article. PMID:20458681

  18. Health coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial

    PubMed Central

    Tiedemann, Anne; Rissel, Chris; Howard, Kirsten; Tong, Allison; Merom, Dafna; Smith, Stuart; Wickham, James; Bauman, Adrian; Lord, Stephen R; Vogler, Constance; Lindley, Richard I; Simpson, Judy M; Allman-Farinelli, Margaret; Sherrington, Catherine

    2016-01-01

    Introduction Prevention of falls and promotion of physical activity are essential for maximising well-being in older age. However, there is evidence that promoting physical activity among older people without providing fall prevention advice may increase fall rates. This trial aims to establish the impact of a physical activity and fall prevention programme compared with a healthy eating programme on physical activity and falls among people aged 60+ years. Methods and analysis This cluster randomised controlled trial will involve 60 groups of community-dwelling people aged 60+ years. Participating groups will be randomised to: (1) a physical activity and fall prevention intervention (30 groups), involving written information, fall risk assessment and prevention advice, a pedometer-based physical activity tracker and telephone-based health coaching; or (2) a healthy eating intervention (30 groups) involving written information and telephone-based dietary coaching. Primary outcomes will be objectively measured physical activity at 12 months post-randomisation and self-reported falls throughout the 12-month trial period. Secondary outcomes include: the proportion of fallers, the proportion of people meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and health and community service use. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will be preplanned, conducted while masked to group allocation, will take into account cluster randomisation, and will use an intention-to-treat approach. Ethics and

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

    NASA Astrophysics Data System (ADS)

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

    2016-07-01

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

  20. Development of a Multi-Agent m-Health Application Based on Various Protocols for Chronic Disease Self-Management.

    PubMed

    Park, Hyun Sang; Cho, Hune; Kim, Hwa Sun

    2016-01-01

    The purpose of this study was to develop and evaluate a mobile health application (Self-Management mobile Personal Health Record: "SmPHR") to ensure the interoperability of various personal health devices (PHDs) and electronic medical record systems (EMRs) for continuous self-management of chronic disease patients. The SmPHR was developed for Android 4.0.3, and implemented according to the optimized standard protocol for each interface of healthcare services adopted by the Continua Health Alliance (CHA). That is, the Personal Area Network (PAN) interface between the application and PHD implements ISO/IEEE 11073-20,601, 10,404, 10,407, 10,415, 10,417, and Bluetooth Health Device Profile (HDP), and EMRs with a wide area network (WAN) interface implement HL7 V2.6; the Health Record Network (HRN) interface implements Continuity of Care Document (CCD) and Continuity of Care Record (CCR). Also, for SmPHR, we evaluated the transmission error rate between the interface using four PHDs and personal health record systems (PHRs) from previous research, with 611 users and elderly people after receiving institutional review board (IRB) approval. In the evaluation, the PAN interface showed 15 (2.4 %) errors, and the WAN and HRN interface showed 13 (2.1 %) errors in a total of 611 transmission attempts. Also, we received opinions regarding SmPHR from 15 healthcare professionals who took part in the clinical trial. Thus, SmPHR can be provided as an interconnected PHR mobile health service to patients, allowing 'plug and play' of PHDs and EMRs through various standard protocols. PMID:26573657

  1. Development of a Multi-Agent m-Health Application Based on Various Protocols for Chronic Disease Self-Management.

    PubMed

    Park, Hyun Sang; Cho, Hune; Kim, Hwa Sun

    2016-01-01

    The purpose of this study was to develop and evaluate a mobile health application (Self-Management mobile Personal Health Record: "SmPHR") to ensure the interoperability of various personal health devices (PHDs) and electronic medical record systems (EMRs) for continuous self-management of chronic disease patients. The SmPHR was developed for Android 4.0.3, and implemented according to the optimized standard protocol for each interface of healthcare services adopted by the Continua Health Alliance (CHA). That is, the Personal Area Network (PAN) interface between the application and PHD implements ISO/IEEE 11073-20,601, 10,404, 10,407, 10,415, 10,417, and Bluetooth Health Device Profile (HDP), and EMRs with a wide area network (WAN) interface implement HL7 V2.6; the Health Record Network (HRN) interface implements Continuity of Care Document (CCD) and Continuity of Care Record (CCR). Also, for SmPHR, we evaluated the transmission error rate between the interface using four PHDs and personal health record systems (PHRs) from previous research, with 611 users and elderly people after receiving institutional review board (IRB) approval. In the evaluation, the PAN interface showed 15 (2.4 %) errors, and the WAN and HRN interface showed 13 (2.1 %) errors in a total of 611 transmission attempts. Also, we received opinions regarding SmPHR from 15 healthcare professionals who took part in the clinical trial. Thus, SmPHR can be provided as an interconnected PHR mobile health service to patients, allowing 'plug and play' of PHDs and EMRs through various standard protocols.

  2. The EARN-Health Trial: protocol for a randomised controlled trial to identify health effects of a financial savings programme among low-income US adults

    PubMed Central

    Basu, Sanjay; Hamad, Rita; White, Justin S; Modrek, Sepideh; Rehkopf, David H; Cullen, Mark R

    2015-01-01

    Introduction A theory within the social epidemiology field is that financial stress related to having inadequate financial savings may contribute to psychological stress, poor mental health and poor health-related behaviours among low-income US adults. Our objective is to test whether an intervention that encourages financial savings among low-income US adults improves health behaviours and mental health. Methods and analysis A parallel group two-arm controlled superiority trial will be performed in which 700 participants will be randomised to the intervention or a wait list. The intervention arm will be provided an online Individual Development Account (IDA) for 6 months, during which participants receive a $5 incentive (£3.2, €4.5) for every month they save $20 in their account (£12.8, €18), and an additional $5 if they save $20 for two consecutive months. Both groups will be provided links to standard online financial counselling materials. Online surveys in months 0 (prior to randomisation), 6 and 12 (6 months postintervention) will assess self-reported health behaviours and mental health among participants in both arms. The surveys items were tested previously in the US Centers for Disease Control and Prevention national health interviews and related health studies, including self-reported overall health, health-related quality of life, alcohol and tobacco use, depression symptoms, financial stress, optimism and locus of control, and spending and savings behaviours. Trial data will be analysed on an intent-to-treat basis. Ethics and dissemination This protocol was approved by the Institutional Review Board of Stanford University (Protocol ID: 30641). The findings of the trial will be disseminated through peer-reviewed publication. Trial registration number Identifier NCT02185612; Pre-results. PMID:26443663

  3. Preparedness for a major incident: creation of an epidemiology protocol for a health protection register in England.

    PubMed

    Close, R M; Maguire, H; Etherington, G; Brewin, C R; Fong, K; Saliba, V; Barker, R M; Leonardi, G S

    2014-11-01

    Large incidents and natural disasters are on the increase globally. They can have a major impact lasting many years or decades; and can affect large groups of people including those that are more susceptible to adverse consequences. Following a major incident, it may be considered necessary to establish a register of those people affected by the incident to provide appropriate advice on relevant immediate and longer-term public health interventions that may be required, provide reassurance to the public that their care is paramount, to reassure the worried well to avoid them inappropriately overwhelming local services, and to facilitate epidemiological investigations. Arrangements for the prompt follow-up of populations after large incidents or disasters have been agreed in England and a protocol for establishing a register of individuals potentially affected by a large incident has been developed. It is important for countries to have a protocol for implementing a health register if the circumstances require one to be in place, and are supported by Public Health Authorities. Health registers facilitate the initial descriptive epidemiology of exposure and provide the opportunity of carrying out long term analytical studies on the affected population. Such epidemiological studies provide a greater understanding of the impact that a large incident can have on health, which in turn helps in the planning of health care provision. Registers can also assist more directly in providing access to individuals in need of physical and mental health interventions. The challenge that still remains is to formally pilot the register in the field and refine it based on that experience.

  4. Understanding the motivation and performance of community health volunteers involved in the delivery of health programmes in Kampala, Uganda: a realist evaluation protocol

    PubMed Central

    Vareilles, Gaëlle; Pommier, Jeanine; Kane, Sumit; Pictet, Gabriel; Marchal, Bruno

    2015-01-01

    Introduction The recruitment of community health volunteers to support the delivery of health programmes is a well-established approach in many countries, particularly where health services are not readily available. However, studies on management of volunteers are scarce and current research on human resource management of volunteers faces methodological challenges. This paper presents the protocol of a realist evaluation that aims at identifying the factors influencing the performance of community health volunteers involved in the delivery of a Red Cross immunisation programme in Kampala (Uganda) with a specific focus on motivation. Methods and analysis The realist evaluation cycle structures the protocol. To develop the theoretical basis for the evaluation, the authors conducted interviews and reviewed the literature on community health volunteers’ performance, management and organisational behaviour. This led to the formulation of the initial programme theory, which links the intervention inputs (capacity-building strategies) to the expected outcomes (positive work behaviour) with mechanisms that point in the direction of drivers of motivation. The contextual elements include components such as organisational culture, resource availability, etc. A case study design will be adopted. We define a case as a Red Cross branch, run by a programme manager, and will select two cases at the district level in Kampala. Mixed methods will be used in data collection, including individual interviews of volunteers, participant observation and document review. The thematic analysis will be based on the initial programme theory and will seek for context-mechanism-outcome configurations. Findings from the two cases will be compared. Discussion We discuss the scope for applying realist evaluation and the methodological challenges we encountered in developing this protocol. Ethics and dissemination The study was approved by the Ethical Committee at Rennes University Hospital

  5. An improved pyrite pretreatment protocol for kinetic and isotopic studies

    NASA Astrophysics Data System (ADS)

    Mirzoyan, Natella; Kamyshny, Alexey; Halevy, Itay

    2014-05-01

    An improved pyrite pretreatment protocol for kinetic and isotopic studies Natella Mirzoyan1, Alexey Kamyshny Jr.2, Itay Halevy1 1Earth and Planetary Sciences, Weizmann Institute of Science, Rehovot 76100, Israel 2Geological and Environmental Sciences, Ben-Gurion University of the Negev, Beer Sheva 84105, Israel Pyrite is one of the most abundant and widespread of the sulfide minerals with a central role in biogeochemical cycles of iron and sulfur. Due to its diverse roles in the natural and anthropogenic sulfur cycle, pyrite has been extensively studied in various experimental investigations of the kinetics of its dissolution and oxidation, the isotopic fractionations associated with these reactions, and the microbiological processes involved. Pretreatment of pyrite for removal of oxidation impurities to prevent experimental artifacts and inaccuracies is often practiced. While numerous pyrite-cleaning methods have been used in experiments, a common pyrite pretreatment method, often used to investigate pyrite chemistry by the isotopic fractionations associated with it, includes several rinses by HCl, acetone and deionized water. Elemental sulfur (S0) is a common product of incomplete pyrite oxidation. Removal of S0 is desirable to avoid experimental biases associated with its participation in pyrite transformations, but is more complicated than the removal of sulfate. Although rinsing with an organic solvent is in part aimed at removing S0, to the best of our knowledge, the extraction efficiency of S0 in existing protocols has not been assessed. We have developed and tested a new protocol for elemental sulfur removal from the surface of pyrite by ultrasonication with warm acetone. Our data demonstrate the presence of large fractions of S0 on untreated pyrite particle surfaces, of which only approximately 60% was removed by the commonly used pretreatment method. The new protocol described here was found to be more efficient at S0 removal than the commonly used method

  6. A Self-Regulation eHealth Intervention to Increase Healthy Behavior Through General Practice: Protocol and Systematic Development

    PubMed Central

    De Bourdeaudhuij, Ilse; Verloigne, Maite; Oenema, Anke; Crombez, Geert

    2015-01-01

    Background Chronic diseases are the principal cause of morbidity and mortality worldwide. An increased consumption of vegetables and fruit reduces the risk of hypertension, coronary heart disease, stroke, and cancer. An increased fruit and vegetable (FV) intake may also prevent body weight gain, and therefore indirectly affect type 2 diabetes mellitus. Insufficient physical activity (PA) has been identified as the fourth leading risk factor for global mortality. Consequently, effective interventions that promote PA and FV intake in a large number of people are required. Objective To describe the systematic development of an eHealth intervention, MyPlan 1.0, for increasing FV intake and PA. Methods The intervention was developed following the six steps of the intervention mapping (IM) protocol. Decisions during steps were based upon available literature, focus group interviews, and pilot studies. Results Based on needs assessment (Step 1), it was decided to focus on fruit and vegetable intake and physical activity levels of adults. Based on self-regulation and the health action process approach model, motivational (eg, risk awareness) and volitional (eg, action planning) determinants were selected and crossed with performance objectives into a matrix with change objectives (Step 2). Behavioral change strategies (eg, goal setting, problem solving, and implementation intentions) were selected (Step 3). Tablet computers were chosen for delivery of the eHealth program in general practice (Step 4). To facilitate implementation of the intervention in general practice, GPs were involved in focus group interviews (Step 5). Finally, the planning of the evaluation of the intervention (Step 6) is briefly described. Conclusions Using the IM protocol ensures that a theory- and evidence-based intervention protocol is developed. If the intervention is found to be effective, a dynamic eHealth program for the promotion of healthy lifestyles could be available for use in general

  7. Neurofeedback for insomnia: a pilot study of Z-score SMR and individualized protocols.

    PubMed

    Hammer, Barbara U; Colbert, Agatha P; Brown, Kimberly A; Ilioi, Elena C

    2011-12-01

    Insomnia is an epidemic in the US. Neurofeedback (NFB) is a little used, psychophysiological treatment with demonstrated usefulness for treating insomnia. Our objective was to assess whether two distinct Z-Score NFB protocols, a modified sensorimotor (SMR) protocol and a sequential, quantitative EEG (sQEEG)-guided, individually designed (IND) protocol, would alleviate sleep and associated daytime dysfunctions of participants with insomnia. Both protocols used instantaneous Z scores to determine reward condition administered when awake. Twelve adults with insomnia, free of other mental and uncontrolled physical illnesses, were randomly assigned to the SMR or IND group. Eight completed this randomized, parallel group, single-blind study. Both groups received fifteen 20-min sessions of Z-Score NFB. Pre-post assessments included sQEEG, mental health, quality of life, and insomnia status. ANOVA yielded significant post-treatment improvement for the combined group on all primary insomnia scores: Insomnia Severity Index (ISI p<.005), Pittsburgh Sleep Quality Inventory (PSQI p<.0001), PSQI Sleep Efficiency (p<.007), and Quality of Life Inventory (p<.02). Binomial tests of baseline EEGs indicated a significant proportion of excessively high levels of Delta and Beta power (p<.001) which were lowered post-treatment (paired z-tests p<.001). Baseline EEGs showed excessive sleepiness and hyperarousal, which improved post-treatment. Both Z-Score NFB groups improved in sleep and daytime functioning. Post-treatment, all participants were normal sleepers. Because there were no significant differences in the findings between the two groups, our future large scale studies will utilize the less burdensome to administer Z-Score SMR protocol.

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

    PubMed Central

    2012-01-01

    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 shows that a cohort

  9. Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal activation, haemodynamics and health-related quality of life in patients with atrial Fibrillation (SMURF): a protocol for an observational study with a randomised interventional component

    PubMed Central

    Charitakis, Emmanouil; Walfridsson, Ulla; Nyström, Fredrik; Nylander, Eva; Strömberg, Anna; Alehagen, Urban; Walfridsson, Håkan

    2015-01-01

    Introduction Atrial fibrillation (AF) is the most common cardiac arrhythmia, with an estimated prevalence of 1.5–2%. It is an independent risk factor for ischaemic stroke and is estimated to cause about 20–25% of all stroke cases. AF has a great impact on health-related quality of life (HRQoL); however, one unresolved issue related to AF is the wide variation in its symptoms. Methods and analysis The symptom burden, metabolic profile, ultrasound findings, rhythm, neurohormonal activation, haemodynamics and HRQoL in patients with AF (Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal activation, haemodynamics and health-related quality of life in patients with atrial Fibrillation, SMURF) study is a prospective observational, cohort study, with a randomised interventional part. The aim of the study is to investigate, in patients with AF, the relationship between symptom burden and metabolic aspects, atrial function and different neurohormones, and the effect of radiofrequency ablation (RFA). The interventional part of the study will give an insight into the neurohormonal and intracardiac pressure changes directly after initiation of AF. Consecutive patients with symptomatic AF accepted for treatment with RFA for the first time at Linköping University Hospital are eligible for participation. The enrolment started in January 2012, and a total of 200 patients are to be included into the study, with 45 of them being enrolled into the interventional study with initiation of AF. The sample size of the interventional study is based on a small pilot study with 5 patients induced to AF while 2 served as controls. The results indicated that, in order to find a statistically significant difference, there was a need to include 28 patients; for safety reasons, 45 patients will be included. Ethics and dissemination The SMURF study is approved by the Regional Ethical Review Board at the Faculty of Health Sciences, Linköping, Sweden. The results will

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

    PubMed Central

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

    2016-01-01

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

  11. A school-based intervention incorporating smartphone technology to improve health-related fitness among adolescents: rationale and study protocol for the NEAT and ATLAS 2.0 cluster randomised controlled trial and dissemination study

    PubMed Central

    Lubans, David R; Smith, Jordan J; Peralta, Louisa R; Plotnikoff, Ronald C; Okely, Anthony D; Salmon, Jo; Eather, Narelle; Dewar, Deborah L; Kennedy, Sarah; Lonsdale, Chris; Hilland, Toni A; Estabrooks, Paul; Finn, Tara L; Pollock, Emma; Morgan, Philip J

    2016-01-01

    Introduction Physical inactivity has been described as a global pandemic. Interventions aimed at developing skills in lifelong physical activities may provide the foundation for an active lifestyle into adulthood. In general, school-based physical activity interventions targeting adolescents have produced modest results and few have been designed to be ‘scaled-up’ and disseminated. This study aims to: (1) assess the effectiveness of two physical activity promotion programmes (ie, NEAT and ATLAS) that have been modified for scalability; and (2) evaluate the dissemination of these programmes throughout government funded secondary schools. Methods and analysis The study will be conducted in two phases. In the first phase (cluster randomised controlled trial), 16 schools will be randomly allocated to the intervention or a usual care control condition. In the second phase, the Reach, Effectiveness, Adoption, Implementation and Maintenance (Re-AIM) framework will be used to guide the design and evaluation of programme dissemination throughout New South Wales (NSW), Australia. In both phases, teachers will be trained to deliver the NEAT and ATLAS programmes, which will include: (1) interactive student seminars; (2) structured physical activity programmes; (3) lunch-time fitness sessions; and (4) web-based smartphone apps. In the cluster RCT, study outcomes will be assessed at baseline, 6 months (primary end point) and 12-months. Muscular fitness will be the primary outcome and secondary outcomes will include: objectively measured body composition, cardiorespiratory fitness, flexibility, resistance training skill competency, physical activity, self-reported recreational screen-time, sleep, sugar-sweetened beverage and junk food snack consumption, self-esteem and well-being. Ethics and dissemination This study has received approval from the University of Newcastle (H-2014-0312) and the NSW Department of Education (SERAP: 2012121) human research ethics committees. This

  12. Yield and Efficiency of Mental Health Screening: A Comparison of Screening Protocols at Intake to Prison

    PubMed Central

    Potter, Beth K.; Wells, George A.; Colman, Ian

    2016-01-01

    Background The value of screening for mental illness has increasingly been questioned in low prevalence settings due to high false positive rates. However, since false positive rates are related to prevalence, screening may be more effective in higher prevalence settings, including correctional institutions. We compared the yield (i.e. newly detected cases) and efficiency (i.e. false positives) of five screening protocols to detect mental illness in prisons against the use of mental health history taking (the prior approach to detecting mental illness). Methods and Findings We estimated the accuracy of the six approaches to detect an Axis I disorder among a sample of 467 newly admitted male inmates (83.1% participation rate). Mental health history taking identified only 41.0% (95% CI 32.1, 50.6) of all inmates with mental illness. Screening protocols identified between 61.9 and 85.7% of all cases, but referred between 2 and 3 additional individuals who did not have a mental illness for every additional case detected compared to the mental health history taking approach. In low prevalence settings (i.e. 10% or less) the screening protocols would have had between 4.6 and 16.2 false positives per true positive. Conclusions While screening may not be practical in low prevalence settings, it may be beneficial in jails and prisons where the prevalence of mental illness is higher. Further consideration of the context in which screening is being implemented, and of the impacts of policies and clinical practices on the benefits and harms of screening is needed to determine the effectiveness of screening in these settings. PMID:27167222

  13. Recommended Protocol for Round Robin Studies in Additive Manufacturing

    PubMed Central

    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

  14. VehiHealth: An Emergency Routing Protocol for Vehicular Ad Hoc Network to Support Healthcare System.

    PubMed

    Bhoi, S K; Khilar, P M

    2016-03-01

    Survival of a patient depends on effective data communication in healthcare system. In this paper, an emergency routing protocol for Vehicular Ad hoc Network (VANET) is proposed to quickly forward the current patient status information from the ambulance to the hospital to provide pre-medical treatment. As the ambulance takes time to reach the hospital, ambulance doctor can provide sudden treatment to the patient in emergency by sending patient status information to the hospital through the vehicles using vehicular communication. Secondly, the experienced doctors respond to the information by quickly sending a treatment information to the ambulance. In this protocol, data is forwarded through that path which has less link breakage problem between the vehicles. This is done by calculating an intersection value I v a l u e for the neighboring intersections by using the current traffic information. Then the data is forwarded through that intersection which has minimum I v a l u e . Simulation results show VehiHealth performs better than P-GEDIR, GyTAR, A-STAR and GSR routing protocols in terms of average end-to-end delay, number of link breakage, path length, and average response time.

  15. An Integrated Web-Based Mental Health Intervention of Assessment-Referral-Care to Reduce Stress, Anxiety, and Depression in Hospitalized Pregnant Women With Medically High-Risk Pregnancies: A Feasibility Study Protocol of Hospital-Based Implementation

    PubMed Central

    Janes-Kelley, Selikke; Tyrrell, Janie; Clark, Lorna; Hamza, Deena; Holmes, Penny; Parkes, Cheryl; Moyo, Nomagugu; McDonald, Sheila; Austin, Marie-Paule

    2015-01-01

    Background At prevalence rates of up to 40%, rates of depression and anxiety among women with medically complex pregnancies are 3 times greater than those in community-based samples of pregnant women. However, mental health care is not a component of routine hospital-based antenatal care for medically high-risk pregnant women. Objective The purpose of this study is to evaluate the effectiveness and feasibility of the hospital-based implementation of a Web-based integrated mental health intervention comprising psychosocial assessment, referral, and cognitive behavioral therapy (CBT) for antenatal inpatients. Methods This study is a quasi-experimental design. Pregnant women are eligible to participate if they are (1) <37 weeks gestation, (2) admitted to the antenatal inpatient unit for >72 hours, (3) able to speak and read English or be willing to use a translation service to assist with completion of the questionnaires and intervention, (4) able to complete follow-up email questionnaires, (5) >16 years of age, and (6) not actively suicidal. Women admitted to the unit for induction (eg, <72-hour length of stay) are excluded. A minimum sample of 54 women will be recruited from the antenatal high-risk unit of a large, urban tertiary care hospital. All women will complete a Web-based psychosocial assessment and 6 Web-based CBT modules. Results of the psychosocial assessment will be used by a Web-based clinical decision support system to generate a clinical risk score and clinician prompts to provide recommendations for the best treatment and referral options. The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6-8 weeks postrecruitment. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence at 3

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

    PubMed Central

    2011-01-01

    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 different aspects of job

  17. Reducing patients’ suicide ideation through training mental health teams in the application of the Dutch multidisciplinary practice guideline on assessment and treatment of suicidal behavior: study protocol of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background To strengthen suicide prevention skills in mental health care in The Netherlands, multidisciplinary teams throughout the country are trained in the application of the new Dutch guideline on the assessment and treatment of suicidal behavior. Previous studies have shown beneficial effects of additional efforts for guideline implementation on professionals’ attitude, knowledge, and skills. However, the effects on patients are equally important, but are rarely measured. The main objective of this study is to examine whether patients of multidisciplinary teams who are trained in guideline application show greater recovery from suicide ideation than patients of untrained teams. Methods/Design This is a multicentre cluster randomized controlled trial (RCT), in which multidisciplinary teams from mental health care institutions are matched in pairs, and randomly allocated to either the experimental or control condition. In the experimental condition, next to the usual dissemination of the guideline (internet, newsletter, books, publications, and congresses), teams will be trained in the application of the guideline via a 1-day small interactive group training program supported by e-learning modules. In the control condition, no additional actions next to usual dissemination of the guideline will be undertaken. Assessments at patient level will start when the experimental teams are trained. Assessments will take place upon admission and after 3 months, or earlier if the patient is discharged. The primary outcome is suicide ideation. Secondary outcomes are non-fatal suicide attempts, level of treatment satisfaction, and societal costs. Both a cost-effectiveness and cost-utility analysis will be performed. The effects of the intervention will be examined in multilevel models. Discussion The strengths of this study are the size of the study, RCT design, training of complete multidisciplinary teams, and the willingness of both management and staff to participate

  18. Study protocol: cluster randomised controlled trial to assess the clinical and cost effectiveness of a staff training intervention in inpatient mental health rehabilitation units in increasing service users’ engagement in activities

    PubMed Central

    2013-01-01

    Background This study focuses on people with complex and severe mental health problems who require inpatient rehabilitation. The majority have a diagnosis of schizophrenia whose recovery has been delayed due to non-response to first-line treatments, cognitive impairment, negative symptoms and co-existing problems such as substance misuse. These problems contribute to major impairments in social and everyday functioning necessitating lengthy admissions and high support needs on discharge to the community. Engagement in structured activities reduces negative symptoms of psychosis and may lead to improvement in function, but no trials have been conducted to test the efficacy of interventions that aim to achieve this. Methods/design This study aims to investigate the clinical and cost-effectiveness of a staff training intervention to increase service users’ engagement in activities. This is a single-blind, two-arm cluster randomised controlled trial involving 40 inpatient mental health rehabilitation units across England. Units are randomised on an equal basis to receive either standard care or a “hands-on”, manualised staff training programme comprising three distinct phases (predisposing, enabling and reinforcing) delivered by a small team of psychiatrists, occupational therapists, service users and activity workers. The primary outcome is service user engagement in activities 12 months after randomisation, assessed using a standardised measure. Secondary outcomes include social functioning and costs and cost-effectiveness of care. Discussion The study will provide much needed evidence for a practical staff training intervention that has potential to improve service user functioning, reducing the need for hospital treatment and supporting successful community discharge. The trial is registered with Current Controlled Trials (Ref ISRCTN25898179). PMID:23981710

  19. Association between progression-free survival and health-related quality of life in oncology: a systematic review protocol

    PubMed Central

    Kovic, Bruno; Guyatt, Gordon; Brundage, Michael; Thabane, Lehana; Bhatnagar, Neera; Xie, Feng

    2016-01-01

    Introduction There is an increasing number of new oncology drugs being studied, approved and put into clinical practice based on improvement in progression-free survival, when no overall survival benefits exist. In oncology, the association between progression-free survival and health-related quality of life is currently unknown, despite its importance for patients with cancer, and the unverified assumption that longer progression-free survival indicates improved health-related quality of life. Thus far, only 1 study has investigated this association, providing insufficient evidence and inconclusive results. The objective of this study protocol is to provide increased transparency in supporting a systematic summary of the evidence bearing on this association in oncology. Methods and analysis Using the OVID platform in MEDLINE, Embase and Cochrane databases, we will conduct a systematic review of randomised controlled human trials addressing oncology issues published starting in 2000. A team of reviewers will, in pairs, independently screen and abstract data using standardised, pilot-tested forms. We will employ numerical integration to calculate mean incremental area under the curve between treatment groups in studies for health-related quality of life, along with total related error estimates, and a 95% CI around incremental area. To describe the progression-free survival to health-related quality of life association, we will construct a scatterplot for incremental health-related quality of life versus incremental progression-free survival. To estimate the association, we will use a weighted simple regression approach, comparing mean incremental health-related quality of life with either median incremental progression-free survival time or the progression-free survival HR, in the absence of overall survival benefit. Discussion Identifying direction and magnitude of association between progression-free survival and health-related quality of life is critically

  20. Infection Control Protocol for Student Clinical Experiences. A Protocol Document for Health Occupations Education Programs in Missouri.

    ERIC Educational Resources Information Center

    Missouri Univ., Columbia. Instructional Materials Lab.

    Developed especially for high school health occupations education programs in Missouri, this guide uses U.S. Occupational Safety and Health Administration (OSHA) rules as a base for guidelines for student participation in health care. The document informs administrators and teachers about special circumstances that must be considered in the…

  1. Racism as a determinant of health: a protocol for conducting a systematic review and meta-analysis

    PubMed Central

    2013-01-01

    Background Racism is increasingly recognized as a key determinant of health. A growing body of epidemiological evidence shows strong associations between self-reported racism and poor health outcomes across diverse minority groups in developed countries. While the relationship between racism and health has received increasing attention over the last two decades, a comprehensive meta-analysis focused on the health effects of racism has yet to be conducted. The aim of this review protocol is to provide a structure from which to conduct a systematic review and meta-analysis of studies that assess the relationship between racism and health. Methods This research will consist of a systematic review and meta-analysis. Studies will be considered for review if they are empirical studies reporting quantitative data on the association between racism and health for adults and/or children of all ages from any racial/ethnic/cultural groups. Outcome measures will include general health and well-being, physical health, mental health, healthcare use and health behaviors. Scientific databases (for example, Medline) will be searched using a comprehensive search strategy and reference lists will be manually searched for relevant studies. In addition, use of online search engines (for example, Google Scholar), key websites, and personal contact with experts will also be undertaken. Screening of search results and extraction of data from included studies will be independently conducted by at least two authors, including assessment of inter-rater reliability. Studies included in the review will be appraised for quality using tools tailored to each study design. Summary statistics of study characteristics and findings will be compiled and findings synthesized in a narrative summary as well as a meta-analysis. Discussion This review aims to examine associations between reported racism and health outcomes. This comprehensive and systematic review and meta-analysis of empirical research

  2. ‘HeART of Stroke (HoS)’, a community-based Arts for Health group intervention to support self-confidence and psychological well-being following a stroke: protocol for a randomised controlled feasibility study

    PubMed Central

    Ellis-Hill, Caroline; Gracey, Fergus; Thomas, Sarah; Lamont-Robinson, Catherine; Thomas, Peter W; Marques, Elsa M R; Grant, Mary; Nunn, Samantha; Cant, Robin P I; Galvin, Kathleen T; Reynolds, Frances; Jenkinson, Damian F

    2015-01-01

    Introduction Over 152 000 people in the UK have strokes annually and a third experience residual disability. Low mood also affects a third of stroke survivors; yet psychological support is poor. While Arts for Health interventions have been shown to improve well-being in people with mild-to-moderate depression post-stroke, their role in helping people regain sense of self, well-being and confidence has yet to be evaluated. The main aim of this study is to explore the feasibility of conducting a pragmatic multicentre randomised controlled trial to assess the effectiveness and cost-effectiveness of an Arts for Health group intervention (‘HeART of Stroke’ (HoS)) for stroke survivors. HoS is a 10-session artist-facilitated group intervention held in the community over 14 weeks. It offers a non-judgemental, supportive environment for people to explore sense of self, potentially enhancing well-being and confidence. Methods and analysis Sixty-four people, up to 2 years post-stroke, recruited via secondary care research staff or community stroke/rehabilitation teams in two UK centres will be randomised to either HoS plus usual care or usual care only. Self-reported outcomes, measured at baseline and approximately 5 months postrandomisation, will include stroke-related, well-being, mood, self-esteem, quality of life and process measures. Analyses will focus on estimating key feasibility parameters (eg, rates of recruitment, retention, intervention attendance). We will develop outcome and resource use data collection methods to inform an effectiveness and cost-effectiveness analysis in the future trial. Interviews, with a sample of participants, will explore the acceptability of the intervention and study processes, as well as experiences of the HoS group. Ethics and dissemination National Health Service (NHS), Research and Development and University ethical approvals have been obtained. Two peer-reviewed journal publications are planned plus one service user led

  3. Study & Analysis of various Protocols in popular Web Browsers

    NASA Astrophysics Data System (ADS)

    Mishra, Bharat; Baghel, Harish Singh; Patil, Manoj; Singh, Pramod

    2012-08-01

    The web browsers are the application software that are used to access information from the World Wide Web. With the increasing popularity of the web browsers, the modern web browsers are designed to contain more features as compared to the existing web browsers. For the transferring of information through these browsers, various protocols have been implemented on these modern web browsers to make these browsers more efficient. Different protocols used in different layers have different functions and by increasing the efficiency of these protocols we can make the working of browsers more efficient.

  4. Should I stay or should I go? Understanding families’ decisions regarding initiating, continuing, and terminating health services for managing pediatric obesity: the protocol for a multi-center, qualitative study

    PubMed Central

    2012-01-01

    , continuation, and termination of care. Demographic and anthropometric/clinical data will also be collected. Discussion A better understanding of family involvement in pediatric weight management care will help to improve existing health services in this area. Study data will be used in future research to develop a validated survey that clinicians working in pediatric obesity management can use to understand and enhance their own health services delivery. PMID:23276163

  5. Telemedicine for Gestational Diabetes Mellitus (TeleGDM): A Mixed-Method Study Protocol of Effects of a Web-Based GDM Support System on Health Service Utilization, Maternal and Fetal Outcomes, Costs, and User Experience

    PubMed Central

    Lim, Kwang; Blackberry, Irene; Gray, Kathleen; Furler, John

    2016-01-01

    Background Women with insulin-treated gestational diabetes mellitus (GDM) require close monitoring and support to manage their diabetes. Recent changes to the diagnostic criteria have implications for service provision stemming from increased prevalence, suggesting an increased burden on health services in the future. Telemedicine may augment usual care and mitigate service burdens without compromising clinical outcomes but evidence in GDM is limited. Objective The Telemedicine for Gestational Diabetes Mellitus (TeleGDM) trial aims to explore the use of telemedicine in supporting care and management of women with GDM treated with insulin. Methods The TeleGDM is a mixed-methods study comprising an exploratory randomized controlled trial (RCT) and a qualitative evaluation using semistructured interviews. It involves women with insulin-treated GDM who are up to 35 weeks gestation. Participating patients (n=100) are recruited face-to-face in outpatient GDM clinics at an outer metropolitan tertiary hospital with a culturally diverse catchment and a regional tertiary hospital. The second group of participants (n=8) comprises Credentialed Diabetes Educator Registered Nurses involved in routine care of the women with GDM at the participating clinics. The RCT involves use of a Web-based patient-controlled personal health record for GDM data sharing between patients and clinicians compared to usual care. Outcomes include service utilization, maternal and fetal outcomes (eg, glycemic control, 2nd and 3rd trimester fetal size, type of delivery, baby birth weight), diabetes self-efficacy, satisfaction, and costs. Semistructured interviews will be used to examine user experiences and acceptability of telemedicine. Results The trial recruitment is currently underway. Results are expected by the end of 2016 and will be reported in a follow-up paper. Conclusions Innovative use of technology in supporting usual care delivery in women with GDM may facilitate timely access to GDM

  6. Eating As Treatment (EAT) study protocol: a stepped-wedge, randomised controlled trial of a health behaviour change intervention provided by dietitians to improve nutrition in patients with head and neck cancer undergoing radiotherapy

    PubMed Central

    Britton, Ben; McCarter, Kristen; Baker, Amanda; Wolfenden, Luke; Wratten, Chris; Bauer, Judith; Beck, Alison; McElduff, Patrick; Halpin, Sean; Carter, Gregory

    2015-01-01

    Introduction Maintaining adequate nutrition for Head and Neck Cancer (HNC) patients is challenging due to both the malignancy and the rigours of radiation treatment. As yet, health behaviour interventions designed to maintain or improve nutrition in patients with HNC have not been evaluated. The proposed trial builds on promising pilot data, and evaluates the effectiveness of a dietitian-delivered health behaviour intervention to reduce malnutrition in patients with HNC undergoing radiotherapy: Eating As Treatment (EAT). Methods and analysis A stepped-wedge cluster randomised design will be used. All recruitment hospitals begin in the control condition providing treatment as usual. In a randomly generated order, oncology staff at each hospital will receive 2 days of training in EAT before switching to the intervention condition. Training will be supplemented by ongoing supervision, coaching and a 2-month booster training provided by the research team. EAT is based on established behaviour change counselling methods, including motivational interviewing, cognitive–behavioural therapy, and incorporates clinical practice change theory. It is designed to improve motivation to eat despite a range of barriers (pain, mucositis, nausea, reduced or no saliva, taste changes and appetite loss), and to provide patients with practical behaviour change strategies. EAT will be delivered by dietitians during their usual consultations. 400 patients with HNC (nasopharynx, hypopharynx, oropharynx, oral cavity or larynx), aged 18+, undergoing radiotherapy (>60 Gy) with curative intent, will be recruited from radiotherapy departments at 5 Australian sites. Assessments will be conducted at 4 time points (first and final week of radiotherapy, 4 and 12 weeks postradiotherapy). The primary outcome will be a nutritional status assessment. Ethics and dissemination Ethics approval from all relevant bodies has been granted. Study findings will be disseminated widely through peer

  7. A Cluster-Randomized Controlled Trial Evaluating the Effectiveness and Cost-Effectiveness of Tobacco Cessation on Prescription in Swedish Primary Health Care: A Protocol of the Motivation 2 Quit (M2Q) Study

    PubMed Central

    Lindgren, Peter; Sundberg, Carl Johan; Petzold, Max; Tomson, Tanja

    2016-01-01

    Background In Sweden, the prevalence of tobacco use is disproportionately high among socioeconomically disadvantaged groups. Previous research and clinical experience suggest that prescribed lifestyle interventions in the primary health care (PHC) setting such as Physical Activity on Prescription are effective in changing behavior. However, there is a lack of evidence for if and how such a prescription approach could be effectively transferred into the tobacco cessation context. Objective The aim of this trial is to evaluate the effectiveness and cost-effectiveness of Tobacco Cessation on Prescription (TCP) compared to current practice for tobacco cessation targeting socioeconomically disadvantaged groups in the PHC setting in Sweden. Methods The design is a pragmatic cluster-randomized controlled trial. The sample will consist of 928 daily tobacco users with Swedish social security numbers and permanent resident permits, recruited from 14-20 PHC centers located in socioeconomically disadvantaged areas in Stockholm County. The primary outcome will be measured in self-reported 7-day abstinence at 6 and 12 months after the intervention. The secondary outcomes will be measured in daily tobacco consumption, number of quit attempts, and health-related quality of life at 6 and 12 months after the intervention. Data will be collected through questionnaires and review of electronic medical records. Cost-effectiveness will be estimated through decision analytic modeling and measured by the incremental cost per quality-adjusted life year. Results In the first set of PHC centers participating in the study, eight centers have been included. Recruitment of individual study participants is currently ongoing. Inclusion of a second set of PHC centers is ongoing with expected study start in September 2016. Conclusions If TCP is found effective and cost-effective compared to standard treatment, the method could be implemented to facilitate tobacco cessation for socioeconomically

  8. Evaluating outpatient transition clinics: a mixed-methods study protocol

    PubMed Central

    Sattoe, Jane N T; Peeters, Mariëlle A C; Hilberink, Sander R; Ista, Erwin; van Staa, AnneLoes

    2016-01-01

    Introduction To support young people in their transition to adulthood and transfer to adult care, a number of interventions have been developed. One particularly important intervention is the transition clinic (TC), where paediatric and adult providers collaborate. TCs are often advocated as best practices in transition care for young people with chronic conditions, but little is known about TC models and effects. The proposed study aims to gain insight into the added value of a TC compared with usual care (without a TC). Methods and analysis We propose a mixed-methods study with a retrospective controlled design consisting of semistructured interviews among healthcare professionals, observations of consultations with young people, chart reviews of young people transferred 2–4 years prior to data collection and questionnaires among the young people included in the chart reviews. Qualitative data will be analysed through thematic analysis and results will provide insights into structures and daily routines of TCs, and experienced barriers and facilitators in transitional care. Quantitatively, within-group differences on clinical outcomes and healthcare use will be studied over the four measurement moments. Subsequently, comparisons will be made between intervention and control groups on all outcomes at all measurement moments. Primary outcomes are ‘no-show after transfer’ (process outcome) and ‘experiences and satisfaction with the transfer’ (patient-reported outcome). Secondary outcomes consider clinical outcomes, healthcare usage, self-management outcomes and perceived quality of care. Ethics The Medical Ethical Committee of the Erasmus Medical Centre approved the study protocol (MEC-2014-246). Dissemination Study results will be disseminated through peer-reviewed journals and conferences. The study started in September 2014 and will continue until December 2016. The same study design will be used in a national study in 20 diabetes settings (2016

  9. Study downplays health concerns

    SciTech Connect

    Stringer, J.

    1996-03-13

    A government-funded study has concluded that reformulated gasoline containing methyl tert-butyl ether (MTBE) does not increase short-term health risks when compared with gasoline that does not contain the additive. The study, performed by the Health Effects Institute (Cambridge, MA), compared data from dozens of animal, human, and epidemiological studies of health effects linked to oxygenates, including MTBE and ethanol, but did not find enough evidence to warrant an immediate reduction in oxygenate use. However, the study did recommend that additional research be conducted on possible health consequences associated with the gasoline additives, including neurotoxic effects, if oxygenates continue to be used long term. Oxygenates have been used in gasoline since 1992, when EPA mandated that several municipalities use MTBE or other oxygenates in reformulated gasoline to reduce carbon monoxide emissions and meet Clean Air Act requirements. Shortly after the program began, residents in areas where the oxygenates were used complained of nausea, headaches, and dizziness. The institute says the study--funded by EPA and the Centers for Disease Control--will be used for a broader review of gasoline oxygenates by the White House Office of Science and Technology Policy.

  10. Critical Illness Outcome Study: An Observational Study on Protocols and Mortality in Intensive Care Units

    PubMed Central

    Ali, Naeem A.; Gutteridge, David; Shahul, Sajid; Checkley, William; Sevransky, Jonathan; Martin, Greg S.

    2014-01-01

    Introduction Many individual Intensive Care Unit (ICU) characteristics have been associated with patient outcomes, including staffing, expertise, continuity and team structure. Separately, many aspects of clinical care in ICUs have been operationalized through the development of complex treatment protocols. The United State Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) was designed to determine whether the extent of protocol availability and use in ICUs is associated with hospital survival in a large cohort of United States ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS Steering Committee. Methods USCIITG-CIOS is a prospective, observational, ecological multi-centered “cohort” study of mixed ICUs in the U.S. The data collected include organizational information for the ICU (e.g., protocol availability and utilization, multi-disciplinary staffing assessment) and patient level information (e.g. demographics, acute and chronic medical conditions). The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high and low protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize regression modeling to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. There are presently 60 ICUs participating in USCIITG-CIOS to enroll approximately 6,000 study subjects. Conclusions USCIITG-CIOS is a large multicentric study examining the effect of ICU protocol use on patient outcomes. The primary results of this study will inform our understanding of the relationship between protocol availability, use, and patient outcomes in the ICU. Moreover

  11. How to design a (good) epidemiological observational study: epidemiological research protocol at a glance.

    PubMed

    Fronteira, Ines

    2013-01-01

    In this article, we propose a general structure for designing a research protocol of an observational epidemiological study. We start by highlighting the importance of the research protocol, namely in accounting for some bias and guaranteeing methodologic rigor and study reproductability. Next, we reflect on some of the essential elements of a research protocol no matter its objective. We further present some specific issues to be included according to the type of study: cross-sectional, case-control and cohort.

  12. Study protocol: differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes—individual patient data (IPD) meta-analysis and health economic evaluation

    PubMed Central

    2014-01-01

    Background Pregnant women who gain excess weight are at risk of complications during pregnancy and in the long term. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on clinical outcomes. The effect of interventions on varied groups of women based on body mass index, age, ethnicity, socioeconomic status, parity, and underlying medical conditions is not clear. Our individual patient data (IPD) meta-analysis of randomised trials will assess the differential effect of diet- and physical activity-based interventions on maternal weight gain and pregnancy outcomes in clinically relevant subgroups of women. Methods/design Randomised trials on diet and physical activity in pregnancy will be identified by searching the following databases: MEDLINE, EMBASE, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database. Primary researchers of the identified trials are invited to join the International Weight Management in Pregnancy Collaborative Network and share their individual patient data. We will reanalyse each study separately and confirm the findings with the original authors. Then, for each intervention type and outcome, we will perform as appropriate either a one-step or a two-step IPD meta-analysis to obtain summary estimates of effects and 95% confidence intervals, for all women combined and for each subgroup of interest. The primary outcomes are gestational weight gain and composite adverse maternal and fetal outcomes. The difference in effects between subgroups will be estimated and between-study heterogeneity suitably quantified and explored. The potential for publication bias and availability bias in the IPD obtained will be investigated. We will conduct a model-based economic evaluation to assess the cost effectiveness of the interventions to manage

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

    PubMed

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

    2014-01-01

    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. PMID:24748061

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

    PubMed

    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.

  15. Increasing User Involvement in Health Care and Health Research Simultaneously: A Proto-Protocol for "Person-as-Researcher" and Online Decision Support Tools

    PubMed Central

    Kaltoft, Mette Kjer; Nielsen, Jesper Bo; Salkeld, Glenn

    2014-01-01

    Background User involvement is appearing increasingly on policy agendas in many countries, with a variety of proposals for facilitating it. The belief is that it will produce better health for individuals and community, as well as demonstrate greater respect for the basic principles of autonomy and democracy. Objective Our Web-based project aims to increase involvement in health care and health research and is presented in the form of an umbrella protocol for a set of project-specific protocols. We conceptualize the person as a researcher engaged in a continual, living, informal “n-of-1”-type study of the effects of different actions and interventions on their health, including those implying contact with health care services. We see their research as primarily carried out in order to make better decisions for themselves, but they can offer to contribute the results to the wider population. We see the efforts of the "person-as-researcher" as contributing to the total amount of research undertaken in the community, with research not being confined to that undertaken by professional researchers and institutions. This view is fundamentally compatible with both the emancipatory and conventional approaches to increased user involvement, though somewhat more aligned with the former. Methods Our online decision support tools, delivered directly to the person in the community and openly accessible, are to be seen as research resources. They will take the form of interactive decision aids for a variety of specific health conditions, as well as a generic one that supports all health and health care decisions through its focus on key aspects of decision quality. We present a high-level protocol for the condition-specific studies that will implement our approach, organized within the Populations, Interventions, Comparators, Outcomes, Timings, and Settings (PICOTS) framework. Results Our underlying hypothesis concerns the person-as-researcher who is equipped with a

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

    PubMed Central

    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

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

    PubMed

    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

  18. Protocol for fir tree sampling for provenance studies

    NASA Astrophysics Data System (ADS)

    Meisel, Thomas; Bandoniene, Donata; Zettl, Daniela

    2014-05-01

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

  19. [Betadine in the care of friction blisters. Treatment protocol in primary health care].

    PubMed

    Gonzalez de la Guerra, José Manuel; González Campo, Myrian

    2013-06-01

    First prize in the VII edition of the award winning work Betadine for nursing 2012. The dermatitis caused by repeated friction or trauma to the skin are very common in the population, mainly in athletes. The action of shear forces on the skin makes intradermal blisters very painful; being foot the areas more prone to its occurrence and local infection, one of the most common complications during its evolution. The proposed treatment protocol, presents a new technique of cost-effective cure for these injuries from the nursing consultation in Primary Health Care. Currently, there are many techniques in the treatment of these skin changes, but none has established itself as the "gold standard" in its approach. This technique of treatment accelerates regeneration of the injured area, reduces pain, prevents infection and epithelialization time is estimated between four and five days.

  20. The heart healthy lenoir project-an intervention to reduce disparities in hypertension control: study protocol

    PubMed Central

    2013-01-01

    Background Racial disparities in blood pressure control are well established; however the impact of low health literacy (LHL) on blood pressure has garnered less attention. Office based interventions that are created with iterative patient, practice and community stakeholder input and are rolled out incrementally, may help address these disparities in hypertension control. This paper describes our study protocol. Methods/design Using a community based participatory research (CBPR) approach, we designed and implemented a cohort study that includes both a practice level and patient level intervention to enhance the care and support of patients with hypertension in primary care practices in a rural region of eastern North Carolina. The study is divided into a formative phase and an ongoing 2.5 year implementation phase. Our main care enhancement activities include the integration of a community health coach, using home blood pressure monitoring in clinical decision making, standardizing care delivery processes, and working to improve medication adherence. Main outcomes include overall blood pressure change, the differential change in blood pressure by race (African American vs. White) and health literacy level (low vs. higher health literacy). Discussion Using a community based participatory approach in primary care practice settings has helped to engage patients and practice staff and providers in the research effort and in making practice changes to support hypertension care. Practices have engaged at varying levels, but progress has been made in implementing and iteratively improving upon the interventions to date. Trial registration ClinicalTrials.gov NCT01425515. PMID:24156629

  1. [The research protocol II: study designs in clinical research].

    PubMed

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

    2016-01-01

    In clinical research that takes place in health-care areas, most of the studies are performed with human beings as research subjects. The main objectives of these studies are to know the characteristics of one or more groups, the behavior of human diseases, the etiology or causes of diseases, to identify the best diagnostic tools, or to establish the best treatment for a condition or disease in particular. Additionally, some studies are classified as basic bio-medical research; in these investigations, the subjects of study are laboratory animals, tissues, cells, or molecules. In general terms, the objectives of these studies are to understand the physiology, pathogenesis, or biological mechanisms that could explain functions or alterations in one or more systems or body organs. This article will only address clinical research designs.

  2. A Comparative experimental study of media access protocols for wireless radio networks

    SciTech Connect

    Barrett, C. L.; Drozda, M.; Marathe, M. V.

    2001-05-24

    We conduct a comparative experimental analysis of three well known media access protocols: 802.11, CSMA, and MACA for wireless radio networks. Both fixed and ad-hoc networks are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of experiments was to study how (i) the size of the network, (ii) number of open connections, (iii) the spatial location of individual connections, (iv) speed with which individual nodes move and (v) protocols higher up in the protocol stack (e,g. routing layer) affect the performance of the media access sublayer protocols. The performance of the protocols was measured w.r.t. three important parameters: (1) number of received packets, (2) average latency of each packet, and (3) throughput. The following general qualitative conclusions were obtained; some of the conclusions reinforce the earlier claims by other researchers. (1) Although 802.11 performs better than the other two protocols with respect to fairness of transmission, packets dropped, and latency, its performance is found to (i) show a lot of variance with changing input parameters and (ii) the overall performance still leaves a lot of room for improvement. (2) CSMA does not perform too well under the fairness criteria, however, was the best in terms of the latency criteria. (3) MACA also shows fairness problems and has poor performance at high packet injection rates. (4) Protocols in the higher level of the protocol stack affect the MAC layer performance. The main general implications of our work is two folds: (1) No single protocol dominated the other protocols across various measures of efficiency. This motivates the design of a new class of parameterized protocols that adapt to changes in the network connectivity and loads. We refer to these class of protocols as parameterized dynamically adaptive efficient protocols and as a first step suggest key design requirements for such a class of protocols. (2

  3. Internet Protocol Television for Personalized Home-Based Health Information: Design-Based Research on a Diabetes Education System

    PubMed Central

    Clarke, Ken; Kwong, Mabel; Alzougool, Basil; Hines, Carolyn; Tidhar, Gil; Frukhtman, Feodor

    2014-01-01

    Background The use of Internet protocol television (IPTV) as a channel for consumer health information is a relatively under-explored area of medical Internet research. IPTV may afford new opportunities for health care service providers to provide health information and for consumers, patients, and caretakers to access health information. The technologies of Web 2.0 add a new and even less explored dimension to IPTV’s potential. Objective Our research explored an application of Web 2.0 integrated with IPTV for personalized home-based health information in diabetes education, particularly for people with diabetes who are not strong computer and Internet users, and thus may miss out on Web-based resources. We wanted to establish whether this system could enable diabetes educators to deliver personalized health information directly to people with diabetes in their homes; and whether this system could encourage people with diabetes who make little use of Web-based health information to build their health literacy via the interface of a home television screen and remote control. Methods This project was undertaken as design-based research in two stages. Stage 1 comprised a feasibility study into the technical work required to integrate an existing Web 2.0 platform with an existing IPTV system, populated with content and implemented for user trials in a laboratory setting. Stage 2 comprised an evaluation of the system by consumers and providers of diabetes information. Results The project succeeded in developing a Web 2.0 IPTV system for people with diabetes and low literacies and their diabetes educators. The performance of the system in the laboratory setting gave them the confidence to engage seriously in thinking about the actual and potential features and benefits of a more widely-implemented system. In their feedback they pointed out a range of critical usability and usefulness issues related to Web 2.0 affordances and learning fundamentals. They also described

  4. A randomised controlled trial of a consumer-focused e-health strategy for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) study protocol

    PubMed Central

    Redfern, Julie; Usherwood, T; Harris, M F; Rodgers, A; Hayman, N; Panaretto, K; Chow, C; Lau, A Y S; Neubeck, L; Coorey, G; Hersch, F; Heeley, E; Patel, A; Jan, S; Zwar, N; Peiris, D

    2014-01-01

    Introduction Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk. In this project, we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice. Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Islander and non-indigenous adults, recruited through primary care, at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care. Methods and analysis Randomised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk. The trial will be augmented by formal economic and process evaluations to assess acceptability, equity and cost-effectiveness of the intervention. The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management. The programme is electronically integrated with the primary care provider's software and will include interactive smart phone and Internet platforms. The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline-recommended blood pressure (BP) and cholesterol targets. Secondary outcomes include change in mean BP and fasting cholesterol levels, proportion meeting BP and cholesterol targets separately, self-efficacy, health literacy, self-reported point prevalence abstinence in smoking, body mass index and waist circumference, self-reported physical activity and self-reported medication adherence. Ethics and dissemination Primary ethics approval was received from the

  5. Cohort vision study of Apache AH Mk1 pilots: protocol and methodology

    NASA Astrophysics Data System (ADS)

    Hiatt, Keith L.; Braithwaite, Malcolm G.; Crowley, John S.; Rash, Clarence E.; van de Pol, Corina; Ranchino, Daniel J.; Statz, William K.; Eke, Allison J.

    2002-08-01

    A collaborative occupational health study has been undertaken by Headquarters Director Army Aviation, Middle Wallop, UK, and the U.S. Army Aeromedical Research Laboratory, Fort Rucker, Alabama, to determine if the use of the monocular helmet-mounted display in the Apache AH Mk 1 attack helicopter has any long-term (10-year) effect on visual performance. This paper describes the protocol, methodology, development and initial execution phase of this study. The test methodology consists primarily of a battery of vision tests selected to capture changes in visual performance (with an emphasis on binocular visual functions) of Apache aviators over their flight career. It is anticipated that the number of Apache aviators will level out to approximately 70 by the end of the first three years of the study. Non-Apache aviators will serve as a control group.

  6. Protocols to study the physiology of oral biofilms.

    PubMed

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

    2010-01-01

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

  7. e-Health Interventions for Healthy Aging: A Systematic Review Protocol.

    PubMed

    Gagnon, Marie-Pierre; Beogo, Idrissa; Buyl, Ronald

    2016-01-01

    e-Health interventions could contribute to healthy aging (HA) but their effectiveness has not been synthesised. This study aims to systematically review the effectiveness of e-health interventions for supporting HA. We will perform standardized searches to identify experimental and quasi-experimental studies evaluating the effectiveness of e-health interventions for HA. Outcomes of interest are: wellbeing, quality of life, activities of daily living, leisure activities, knowledge, evaluation of care, social support, skill acquisition and healthy behaviours. We will also consider adverse effects such as social isolation, anxiety, and burden on informal caregivers. Two reviewers will independently assess studies for inclusion and extract data using a standardised tool. We will calculate effect sizes related to e-health interventions. If not possible, we will present the findings in a narrative form. This systematic review will provide unique knowledge on the effectiveness of e-health interventions for supporting HA. PMID:27332428

  8. e-Health Interventions for Healthy Aging: A Systematic Review Protocol.

    PubMed

    Gagnon, Marie-Pierre; Beogo, Idrissa; Buyl, Ronald

    2016-01-01

    e-Health interventions could contribute to healthy aging (HA) but their effectiveness has not been synthesised. This study aims to systematically review the effectiveness of e-health interventions for supporting HA. We will perform standardized searches to identify experimental and quasi-experimental studies evaluating the effectiveness of e-health interventions for HA. Outcomes of interest are: wellbeing, quality of life, activities of daily living, leisure activities, knowledge, evaluation of care, social support, skill acquisition and healthy behaviours. We will also consider adverse effects such as social isolation, anxiety, and burden on informal caregivers. Two reviewers will independently assess studies for inclusion and extract data using a standardised tool. We will calculate effect sizes related to e-health interventions. If not possible, we will present the findings in a narrative form. This systematic review will provide unique knowledge on the effectiveness of e-health interventions for supporting HA.

  9. How do primary health care teams learn to integrate intimate partner violence (IPV) management? A realist evaluation protocol

    PubMed Central

    2013-01-01

    Background Despite the existence of ample literature dealing, on the one hand, with the integration of innovations within health systems and team learning, and, on the other hand, with different aspects of the detection and management of intimate partner violence (IPV) within healthcare facilities, research that explores how health innovations that go beyond biomedical issues—such as IPV management—get integrated into health systems, and that focuses on healthcare teams’ learning processes is, to the best of our knowledge, very scarce if not absent. This realist evaluation protocol aims to ascertain: why, how, and under what circumstances primary healthcare teams engage (if at all) in a learning process to integrate IPV management in their practices; and why, how, and under what circumstances team learning processes lead to the development of organizational culture and values regarding IPV management, and the delivery of IPV management services. Methods This study will be conducted in Spain using a multiple-case study design. Data will be collected from selected cases (primary healthcare teams) through different methods: individual and group interviews, routinely collected statistical data, documentary review, and observation. Cases will be purposively selected in order to enable testing the initial middle-range theory (MRT). After in-depth exploration of a limited number of cases, additional cases will be chosen for their ability to contribute to refining the emerging MRT to explain how primary healthcare learn to integrate intimate partner violence management. Discussion Evaluations of health sector responses to IPV are scarce, and even fewer focus on why, how, and when the healthcare services integrate IPV management. There is a consensus that healthcare professionals and healthcare teams play a key role in this integration, and that training is important in order to realize changes. However, little is known about team learning of IPV management, both in

  10. A Systematic Review Protocol to Assess the Effects of Physical Activity on Health and Quality of Life Outcomes in Adolescent Cancer Survivors

    PubMed Central

    Wurz, Amanda

    2016-01-01

    Background The benefits of physical activity for child and adult cancer survivors have been summarized in previous systematic reviews. However, no review has summarized the evidence for adolescent cancer survivors. Objective This paper describes the design of a protocol to conduct a systematic review of published studies examining the effects of physical activity on health and quality of life outcomes for adolescent cancer survivors. Methods Several guidelines informed the development of this protocol. The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines provided the structure by which to conduct and report the protocol; though some adaptations were made with regards to search terms, data synthesis, and evaluating the risk of bias. The Cochrane Handbook for Systematic Reviews of Interventions was used to guide research question development, search term selection, and the data extraction form. The Consolidated Standards of Reporting Trials guidelines helped inform the data extraction form. Lastly, the Guidance on the Conduct of Narrative Synthesis in Systematic Reviews informed the data synthesis. Ten electronic databases were identified and a search strategy was developed using a combination of Medical Subject Headings terms and keywords that were developed by the authors and peer reviewed by a university librarian. Both authors independently screened eligible studies for final inclusion, and data were abstracted using a form developed by the research team. A decision was made to synthesize all data narratively. Results The review has now been completed, peer-reviewed, and accepted for publication in a forthcoming issue of JMIR Cancer. Conclusions As this will be the first systematic review on this topic, outlining the protocol ensures transparency for the completed review. Further, this protocol illustrates how elements from several guidelines were incorporated to answer the research question (ie, what is the effect of

  11. Change to costs and lengths of stay in the emergency department and the Brisbane protocol: an observational study

    PubMed Central

    Cheng, Qinglu; Greenslade, Jaimi H; Parsonage, William A; Barnett, Adrian G; Merollini, Katharina; Graves, Nicholas; Peacock, W Frank; Cullen, Louise

    2016-01-01

    Objective To compare health service cost and length of stay between a traditional and an accelerated diagnostic approach to assess acute coronary syndromes (ACS) among patients who presented to the emergency department (ED) of a large tertiary hospital in Australia. Design, setting and participants This historically controlled study analysed data collected from two independent patient cohorts presenting to the ED with potential ACS. The first cohort of 938 patients was recruited in 2008–2010, and these patients were assessed using the traditional diagnostic approach detailed in the national guideline. The second cohort of 921 patients was recruited in 2011–2013 and was assessed with the accelerated diagnostic approach named the Brisbane protocol. The Brisbane protocol applied early serial troponin testing for patients at 0 and 2 h after presentation to ED, in comparison with 0 and 6 h testing in traditional assessment process. The Brisbane protocol also defined a low-risk group of patients in whom no objective testing was performed. A decision tree model was used to compare the expected cost and length of stay in hospital between two approaches. Probabilistic sensitivity analysis was used to account for model uncertainty. Results Compared with the traditional diagnostic approach, the Brisbane protocol was associated with reduced expected cost of $1229 (95% CI −$1266 to $5122) and reduced expected length of stay of 26 h (95% CI −14 to 136 h). The Brisbane protocol allowed physicians to discharge a higher proportion of low-risk and intermediate-risk patients from ED within 4 h (72% vs 51%). Results from sensitivity analysis suggested the Brisbane protocol had a high chance of being cost-saving and time-saving. Conclusions This study provides some evidence of cost savings from a decision to adopt the Brisbane protocol. Benefits would arise for the hospital and for patients and their families. PMID:26916691

  12. Improving the performance of community health workers in humanitarian emergencies: a realist evaluation protocol for the PIECES programme

    PubMed Central

    Gilmore, Brynne; Adams, Ben Jack; Bartoloni, Alex; Alhaydar, Bana; McAuliffe, Eilish; Raven, Joanna; Taegtmeyer, Miriam; Vallières, Frédérique

    2016-01-01

    Introduction Understanding what enhances the motivation and performance of community health workers (CHWs) in humanitarian emergencies represents a key research gap within the field of human resources for health. This paper presents the research protocol for the Performance ImprovEment of CHWs in Emergency Settings (PIECES) research programme. Enhancing Learning and Research in Humanitarian Action (ELRHA) funded the development of this protocol as part of their Health in Humanitarian Crises (R2HC) call (No.19839). PIECES aims to understand what factors improve the performance of CHWs in level III humanitarian emergencies. Methods and analysis The suggested protocol uses a realist evaluation with multiple cases across the 3 country sites: Turkey, Iraq and Lebanon. Working with International Medical Corps (IMC), an initial programme theory was elicited through literature and document reviews, semistructured interviews and focus groups with IMC programme managers and CHWs. Based on this initial theory, this protocol proposes a combination of semistructured interviews, life histories and critical incident narratives, surveys and latent variable modelling of key constructs to explain how contextual factors work to trigger mechanisms for specific outcomes relating to IMC's 300+ CHWs' performance. Participants will also include programme staff, CHWs and programme beneficiaries. Realist approaches will be used to better understand ‘what works, for whom and under what conditions’ for improving CHW performance within humanitarian contexts. Ethics and dissemination Trinity College Dublin's Health Policy and Management/Centre for Global Health Research Ethics Committee gave ethical approval for the protocol development phase. For the full research project, additional ethical approval will be sought from: Université St. Joseph (Lebanon), the Ethics Committee of the Ministry of Health in Baghdad (Iraq) and the Middle East Technical University (Turkey). Dissemination

  13. Rationale, Timeline, Study Design, and Protocol Overview of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials

    PubMed Central

    Moler, Frank W.; Silverstein, Faye S.; Meert, Kathleen L.; Clark, Amy E.; Holubkov, Richard; Browning, Brittan; Slomine, Beth S.; Christensen, James R.; Dean, Michael

    2014-01-01

    Objective To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Design Multicenter randomized controlled trials. Setting Pediatric intensive care and cardiac ICUs in the United States and Canada. Patients Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Interventions Therapeutic hypothermia or therapeutic normothermia. Measurements and Main Results From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Conclusions Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials. PMID:23842585

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

    PubMed

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

    2016-02-01

    While the demand for bariatric surgery is increasing, hospital capacity remains limited. The ERABS (Enhanced Recovery After Bariatric Surgery) protocol has been implemented in a number of bariatric centers. We retrospectively compared the operating room logistics and postoperative complications between pre-ERABS and ERABS periods in an academic hospital. The primary endpoint was the length of stay in hospital. The secondary endpoints were turnover times-the time required for preparing the operating room for the next case, induction time (from induction of anesthesia until a patient is ready for surgery), surgical time (duration of surgery), procedure time (duration of stay in the operating room), and the incidence of re-admissions, re-operations and complications during admission and within 30 days after surgery. Of a total of 374 patients, 228 and 146 received surgery following the pre-ERABS and ERABS protocols, respectively. The length of hospital stay was significantly shortened from 3.7 (95 % confidence interval [CI] 3.1-4.7) days to 2.1 (95 % CI 1.6-2.6) days (P < 0.001). Procedure (surgical) times were shortened by 15 (7) min and 12 (5) min for gastric bypass and gastric sleeve surgery, respectively (P < 0.001 for both), by introducing the ERABS protocol. Induction times were reduced from 15.2 (95 % CI 14.3-16.1) min to 12.5 (95 % CI 11.7-13.3) min (P < 0.001).Turnover times were shortened significantly from 38 (95 % CI 44-32) min to 11 (95 % CI 8-14) min. The incidence of re-operations, re-admissions and complications did not change.

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

    PubMed Central

    Vigna-Taglianti, Federica D; Mathis, Federica; Diecidue, Roberto; Burroni, Paola; Iannaccone, Antonio; Lampis, Fabio; Zuccaro, Piergiorgio; Pacifici, Roberta; Versino, Elisabetta; Davoli, Marina; Faggiano, Fabrizio

    2007-01-01

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

  16. Engaging hospitalized patients in clinical care: Study protocol for a pragmatic randomized controlled trial

    PubMed Central

    Prey, Jennifer; Ryan, Beatriz; Alarcon, Irma; Qian, Min; Bakken, Suzanne; Feiner, Steven; Hripcsak, George; Polubriaginof, Fernanda; Restaino, Susan; Schnall, Rebecca; Strong, Philip; Vawdrey, David

    2016-01-01

    Background Patients who are better informed and more engaged in their health care have higher satisfaction with health care and better health outcomes. While patient engagement has been a focus in the outpatient setting, strategies to engage inpatients in their care have not been well studied. We are undertaking a study to assess how patients’ information needs during hospitalization can be addressed with health information technologies. To achieve this aim, we developed a personalized inpatient portal that allows patients to see who is on their care team, monitor their vital signs, review medications being administered, review current and historical lab and test results, confirm allergies, document pain scores and send questions and comments to inpatient care providers. The purpose of this paper is to describe the protocol for the study. Methods/design This pragmatic randomized controlled trial will enroll 426 inpatient cardiology patients at an urban academic medical center into one of three arms receiving: 1) usual care, 2) iPad with general internet access, or 3) iPad with access to the personalized inpatient portal. The primary outcome of this trial is patient engagement, which is measured through the Patient Activation Measure. To assess scalability and potential reach of the intervention, we are partnering with a West Coast community hospital to deploy the patient engagement technology in their environment with an additional 160 participants. Conclusion This study employs a pragmatic randomized control trial design to test whether a personalized inpatient portal will improve patient engagement. If the study is successful, continuing advances in mobile computing technology should make these types of interventions available in a variety of clinical care delivery settings. PMID:26795675

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

    PubMed Central

    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

  18. The effect of enhanced public–private partnerships on Maternal, Newborn and child Health Services and outcomes in Nairobi–Kenya: the PAMANECH quasi-experimental research protocol

    PubMed Central

    Bakibinga, Pauline; Ettarh, Remare; Ziraba, Abdhalah K; Kyobutungi, Catherine; Kamande, Eva; Ngomi, Nicholas; Osindo, Jane

    2014-01-01

    Introduction Rapid urbanisation in Kenya has resulted in growth of slums in urban centres, characterised by poverty, inadequate social services and poor health outcomes. The government's initiatives to improve access to quality healthcare for mothers and children are largely limited to public health facilities, which are few and/or inaccessible in underserved areas such as the slums. The ‘Partnership for Maternal, Newborn and Child Health’ (PAMANECH) project is being implemented in two Nairobi slums, Viwandani and Korogocho, to assess the impact of strengthening public–private partnerships for the delivery of healthcare on the health of mothers, newborns and young children in two informal settlements in Kenya. Methods and analysis This is a quasi-experimental study; our approach is to support private as well as public health providers and the community to enhance access to and demand for quality healthcare services. Key activities include: infrastructural upgrade of selected Private Not-For-Profit health facilities operating in the two slums, building capacity for healthcare providers as well as the Health Management Teams in Nairobi, facilitating provision of supportive supervision by the local health authorities and forming networks of Community Health Volunteers (CHVs) to create demand for health services. To assess the impact of the intervention, the study is utilising multiple data sources using a combination of qualitative and quantitative methods. A baseline survey was conducted in 2013 and an end-line survey will be conducted at least 1 year after full implementation of the intervention. Systematic monitoring and documentation of the intervention is on-going to strengthen the case for causal inference. Ethics and dissemination Ethical approval for the study was obtained from the Kenya Medical Research Institute. Key messages from the results will be packaged and widely disseminated through workshops, conference presentations, reports, factsheets and

  19. Perspectives of People Living with HIV on Access to Health Care: Protocol for a Scoping Review

    PubMed Central

    Maybank, Allison; Hurley, Oliver; Modir, Hilary; Farrell, Alison; Marshall, Zack; Kendall, Claire; Johnston, Sharon; Hogel, Matthew; Rourke, Sean B; Liddy, Clare

    2016-01-01

    Background Strategies to improve access to health care for people living with human immunodeficiency virus (PLHIV) have demonstrated limited success. Whereas previous approaches have been informed by the views of health providers and decision-makers, it is believed that incorporating patient perspectives into the design and evaluations of health care programs will lead to improved access to health care services. Objective We aim to map the literature on the perspectives of PLHIV concerning access to health care services, to identify gaps in evidence, and to produce an evidence-informed research action plan to guide the Living with HIV program of research. Methods This scoping review includes peer-reviewed and grey literature from 1946 to May 2014 using double data extraction. Variations of the search terms “HIV”, “patient satisfaction”, and “health services accessibility” are used to identify relevant literature. The search strategy is being developed in consultation with content experts, review methodologists, and a librarian, and validated using gold standard studies identified by those stakeholders. The inclusion criteria are (1) the study includes the perspectives of PLHIV, (2) study design includes qualitative, quantitative, or mixed methods, and (3) outcome measures are limited to patient satisfaction, their implied needs, beliefs, and desires in relation to access to health care. The papers are extracted by two independent reviewers, including quality assessment. Data is then collated, summarized, and thematically analyzed. Results A total of 12,857 references were retrieved, of which 326 documents were identified as eligible in pre-screening, and 64 articles met the inclusion criteria (56% qualitative studies, 38% quantitative studies and 6% mixed-method studies). Only four studies were conducted in Canada. Data synthesis is in progress and full results are expected in June, 2016. Conclusions This scoping review will record and characterize the

  20. Contributions to variability of clinical measures for use as indicators of udder health status in a clinical protocol.

    PubMed

    Fossing, C; Vaarst, M; Houe, H; Enevoldsen, C

    2006-08-22

    A cross-sectional observational study with repeated observations was conducted on 16 Danish dairy farms to quantify the influence of observer, parity, time (stage in lactation) and farm on variables routinely selected for inclusion in clinical protocols, thereby to enable a more valid comparison of udder health between different herds. During 12 months, participating herds were visited 5 times by project technicians, who examined 20 cows and scored the selected clinical variables. The estimates of effect on variables were derived from a random regression model procedure. Statistical analyses revealed that, although estimates for occurrence of several the variables, e.g. degree of oedema, varied significantly between observers, the effects on many of these estimates were similar in size. Almost all estimates for occurrences of variables were significantly affected either parity and lactation stage, or by both e.g. udder tissue consistency. Some variables, e.g. mange, had high estimates for the farm component, and others e.g. teat skin quality had a high individual component. Several of the variables, e.g. wounds on warts, had a high residual component indicating that a there still was a major part of the variation in data, which was unexplained. It was concluded that most of the variables were relevant for implementation in herd health management, but that adjustments need to be made to improve reliability.

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

    PubMed Central

    Bhattacharyya, Debnath; Kim, Tai-hoon; Pal, Subhajit

    2010-01-01

    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. PMID:22163483

  2. Shock in the first 24 h of intensive care unit stay: observational study of protocol-based fluid management.

    PubMed

    See, Kay Choong; Mukhopadhyay, Amartya; Lau, Samuel Chuan-Xian; Tan, Sandra Ming-Yien; Lim, Tow Keang; Phua, Jason

    2015-05-01

    Precision in fluid management for shock could lead to better clinical outcomes. We evaluated the association of protocol-based fluid management with intensive care unit (ICU) and hospital mortality. We performed an observational study of mechanically ventilated patients admitted directly from our emergency department to the ICU from August 2011 to December 2013, who had circulatory shock in the first 24 h of ICU stay (systolic blood pressure <90 mmHg at ICU admission or lactate >4 mmol/L). Patients with onset of shock beyond 24 h of ICU stay were excluded. Protocol-based fluid management required close physician-nurse cooperation and computerized documentation, checking for fluid response (≥10% arterial pulse pressure or stroke volume increase after two consecutive 250-mL crystalloid boluses), and fluid loading with repeated 500-mL boluses until fluid response became negative. Six hundred twelve mechanically ventilated patients with shock (mean [±SD] age, 63.0 years [16.5]; 252 or 41.2% females; mean Acute Physiology and Chronic Health Evaluation II score, 30.2 [8.8]) were studied. The fluid management protocol was used 455 times for 242 patients (39.5% of 612 patients) within the first 24 h of ICU stay, with 244 (53.6% of 455) positive responses. Adjusted for age, sex, Acute Physiology and Chronic Health Evaluation II score, comorbidity, and admission year, protocol use was associated with reduced ICU mortality (odds ratio, 0.60; 95% confidence interval, 0.39-0.94; P = 0.025) but not hospital mortality (odds ratio, 0.82; 95% confidence interval, 0.54-1.23; P = 0.369). Among mechanically ventilated patients with shock within the first 24 h of ICU stay, about half had positive fluid responses. Adherence to protocol-based fluid management was associated with improved ICU survival.

  3. Managerial leadership for research use in nursing and allied health care professions: a narrative synthesis protocol

    PubMed Central

    2014-01-01

    Background Nurses and allied health care professionals (physiotherapists, occupational therapists, speech and language pathologists, dietitians) form more than half of the clinical health care workforce and play a central role in health service delivery. There is a potential to improve the quality of health care if these professionals routinely use research evidence to guide their clinical practice. However, the use of research evidence remains unpredictable and inconsistent. Leadership is consistently described in implementation research as critical to enhancing research use by health care professionals. However, this important literature has not yet been synthesized and there is a lack of clarity on what constitutes effective leadership for research use, or what kinds of intervention effectively develop leadership for the purpose of enabling and enhancing research use in clinical practice. We propose to synthesize the evidence on leadership behaviours amongst front line and senior managers that are associated with research evidence by nurses and allied health care professionals, and then determine the effectiveness of interventions that promote these behaviours. Methods/Design Using an integrated knowledge translation approach that supports a partnership between researchers and knowledge users throughout the research process, we will follow principles of knowledge synthesis using a systematic method to synthesize different types of evidence involving: searching the literature, study selection, data extraction and quality assessment, and analysis. A narrative synthesis will be conducted to explore relationships within and across studies and meta-analysis will be performed if sufficient homogeneity exists across studies employing experimental randomized control trial designs. Discussion With the engagement of knowledge users in leadership and practice, we will synthesize the research from a broad range of disciplines to understand the key elements of leadership

  4. Understanding the performance and impact of public knowledge translation funding interventions: Protocol for an evaluation of Canadian Institutes of Health Research knowledge translation funding programs

    PubMed Central

    2012-01-01

    Background The Canadian Institutes of Health Research (CIHR) has defined knowledge translation (KT) as a dynamic and iterative process that includes the synthesis, dissemination, exchange, and ethically-sound application of knowledge to improve the health of Canadians, provide more effective health services and products, and strengthen the healthcare system. CIHR, the national health research funding agency in Canada, has undertaken to advance this concept through direct research funding opportunities in KT. Because CIHR is recognized within Canada and internationally for leading and funding the advancement of KT science and practice, it is essential and timely to evaluate this intervention, and specifically, these funding opportunities. Design The study will employ a novel method of participatory, utilization-focused evaluation inspired by the principles of integrated KT. It will use a mixed methods approach, drawing on both quantitative and qualitative data, and will elicit participation from CIHR funded researchers, knowledge users, KT experts, as well as other health research funding agencies. Lines of inquiry will include an international environmental scan, document/data reviews, in-depth interviews, targeted surveys, case studies, and an expert review panel. The study will investigate how efficiently and effectively the CIHR model of KT funding programs operates, what immediate outcomes these funding mechanisms have produced, and what impact these programs have had on the broader state of health research, health research uptake, and health improvement. Discussion The protocol and results of this evaluation will be of interest to those engaged in the theory, practice, and evaluation of KT. The dissemination of the study protocol and results to both practitioners and theorists will help to fill a gap in knowledge in three areas: the role of a public research funding agency in facilitating KT, the outcomes and impacts KT funding interventions, and how KT can

  5. The UK's Draft Guidance for Health in SEA in light of HIA community priorities and the UNECE SEA Protocol

    SciTech Connect

    Posas, Paula J.

    2011-04-15

    The Protocol on Strategic Environmental Assessment (SEA) to the United Nations Economic Commission for Europe (UNECE) Espoo Convention came into force on 11 July 2010. This Protocol, to which the European Union is party, gives a legal basis for enhanced attention to human health in the SEA process. In this context, the United Kingdom's (UK's) 2007 Draft Guidance on Health in Strategic Environmental Assessment represents an important early government-led effort to bring health issues and public health considerations more significantly into the SEA process. Since the UK is a worldwide leader in environmental and various other types of impact assessment, and since other countries may eventually consider its example in efforts to meet UNECE SEA Protocol requirements, scrutiny of its outputs is warranted. This paper thus examines the UK's Draft Guidance from both HIA academic and practitioner perspectives. First it assesses the extent to which the Draft Guidance reflects recent issues and lessons learned in the academic literature. In order to make the assessment, a meta-analysis of 70 HIA-related peer-reviewed articles was undertaken to extract authors' priority recommendations. These recommendations were subsequently compared with the contents of the Draft Guidance. Secondly, the Draft Guidance was assessed for its accordance with recommendations of the UNECE SEA Protocol background paper written by two HIA practitioners. Overall, the Draft Guidance's accordance with both sets of recommendations was found to be high, with only a few easily-remedied gaps. This evaluation suggests that the UK's Draft Guidance can be a useful starting point in the creation of future guidance on health in SEA in both the UK and other countries.

  6. Electronic nicotine delivery devices, and their impact on health and patterns of tobacco use: a systematic review protocol

    PubMed Central

    Glasser, Allison M; Cobb, Caroline O; Teplitskaya, Lyubov; Ganz, Ollie; Katz, Lauren; Rose, Shyanika W; Feirman, Shari; Villanti, Andrea C

    2015-01-01

    Introduction E-cigarettes or electronic nicotine delivery systems (ENDS) have recently attracted considerable attention. Among some individuals there is strong debate and a polarisation of views about the public health benefits versus harms of ENDS. With little regulation, the ENDS market is evolving, and new products are introduced and marketed constantly. Rapid developments in manufacturing, marketing and consumer domains related to ENDS will warrant frequent re-evaluation, based on the state of the evolving science. The purpose of this article is to describe a protocol for an ongoing comprehensive review of the published scientific literature on ENDS. Methods and analysis We will undertake a systematic review of published empirical research literature on ENDS using the National Library of Medicine's PubMed electronic database to search for relevant articles. Data from included studies will be extracted into a standardised form, tables with study details and key outcomes for each article will be created, and studies will be synthesised qualitatively. Ethics and dissemination This review synthesises published literature and presents no primary data. Therefore, no ethical approval is required for this study. Subsequent papers will provide greater detail on results, within select categories, that represent gaps in the literature base. PMID:25926149

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

    NASA Astrophysics Data System (ADS)

    Valet, I.

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

  8. A protocol for a systematic review of knowledge translation strategies in the allied health professions

    PubMed Central

    2011-01-01

    Background Knowledge translation (KT) aims to close the gap between knowledge and practice in order to realize the benefits of research through (a) improved health outcomes, (b) more effective health services and products, and (c) strengthened healthcare systems. While there is some understanding of strategies to put research findings into practice within nursing and medicine, we have limited knowledge of KT strategies in allied health professions. Given the interprofessional nature of healthcare, a lack of guidance for supporting KT strategies in the allied health professions is concerning. Our objective in this study is to systematically review published research on KT strategies in five allied health disciplines. Methods A medical research librarian will develop and implement search strategies designed to identify evidence that is relevant to each question of the review. Two reviewers will perform study selection and quality assessment using standard forms. For study selection, data will be extracted by two reviewers. For quality assessment, data will be extracted by one reviewer and verified by a second. Disagreements will be resolved through discussion or third party adjudication. Within each profession, data will be grouped and analyzed by research design and KT strategies using the Effective Practice and Organisation of Care Review Group classification scheme. An overall synthesis across professions will be conducted. Significance A uniprofessional approach to KT does not represent the interprofessional context it targets. Our findings will provide the first systematic overview of KT strategies used in allied health professionals' clinical practice, as well as a foundation to inform future KT interventions in allied healthcare settings. PMID:21635763

  9. Skylab oral health studies

    NASA Technical Reports Server (NTRS)

    Brown, L. R.; Frome, W. J.; Handler, S.; Wheatcroft, M. G.; Rider, L. J.

    1977-01-01

    Evaluation of Skylab crewmembers for mission related effects on oral health in relation to possible dental injuries provided the following distinctive changes: (1) increased counts of specific anaerobic and streptococcal components; (2) elevations in levels of secretory IgA concurrent with diminutions of salivary lysozyme; and (3) increases in dental calculus and gingival inflammations. The clinical changes are considered to be more influenced by the preexisting state of dental health than by any mission related effects.

  10. Supporting Policy In health with Research: an Intervention Trial (SPIRIT)—protocol for a stepped wedge trial

    PubMed Central

    2014-01-01

    Introduction Governments in different countries have committed to better use of evidence from research in policy. Although many programmes are directed at assisting agencies to better use research, there have been few tests of the effectiveness of such programmes. This paper describes the protocol for SPIRIT (Supporting Policy In health with Research: an Intervention Trial), a trial designed to test the effectiveness of a multifaceted programme to build organisational capacity for the use of research evidence in policy and programme development. The primary aim is to determine whether SPIRIT results in an increase in the extent to which research and research expertise is sought, appraised, generated and used in the development of specific policy products produced by health policy agencies. Methods and analysis A stepped wedge cluster randomised trial involving six health policy agencies located in Sydney, Australia. Policy agencies are the unit of randomisation and intervention. Agencies were randomly allocated to one of three start dates (steps) to receive the 1-year intervention programme, underpinned by an action framework. The SPIRIT intervention is tailored to suit the interests and needs of each agency and includes audit, feedback and goal setting; a leadership programme; staff training; the opportunity to test systems to assist in the use of research in policies; and exchange with researchers. Outcome measures will be collected at each agency every 6 months for 30 months (starting at the beginning of step 1). Ethics and dissemination Ethics approval was granted by the University of Western Sydney Human Research and Ethics Committee HREC Approval H8855. The findings of this study will be disseminated broadly through peer-reviewed publications and presentations at conferences and used to inform future strategies. PMID:24989620

  11. Hand, hip and knee osteoarthritis in a Norwegian population-based study - The MUST protocol

    PubMed Central

    2013-01-01

    Background Knowledge about the prevalence and consequences of osteoarthritis (OA) in the Norwegian population is limited. This study has been designed to gain a greater understanding of musculoskeletal pain in the general population with a focus on clinically and radiologically confirmed OA, as well as risk factors, consequences, and management of OA. Methods/Design The Musculoskeletal pain in Ullensaker STudy (MUST) has been designed as an observational study comprising a population-based postal survey and a comprehensive clinical examination of a sub-sample with self-reported OA (MUST OA cohort). All inhabitants in Ullensaker municipality, Norway, aged 40 to 79 years receive the initial population-based postal survey questionnaire with questions about life style, general health, musculoskeletal pain, self-reported OA, comorbidities, health care utilisation, medication use, and functional ability. Participants who self-report OA in their hip, knee and/or hand joints are asked to attend a comprehensive clinical examination at Diakonhjemmet Hospital, Oslo, including a comprehensive medical examination, performance-based functional tests, different imaging modalities, cardiovascular assessment, blood and urine samples, and a number of patient-reported questionnaires including five OA disease specific instruments. Data will be merged with six national data registries. A subsample of those who receive the questionnaire has previously participated in postal surveys conducted in 1990, 1994, and 2004 with data on musculoskeletal pain and functional ability in addition to demographic characteristics and a number of health related factors. This subsample constitutes a population based cohort with 20 years follow-up. Discussion This protocol describes the design of an observational population-based study that will involve the collection of data from a postal survey on musculoskeletal pain, and a comprehensive clinical examination on those with self-reported hand, hip and

  12. Validity of Short and Long Self-Administered Food Frequency Questionnaires in Ranking Dietary Intake in Middle-Aged and Elderly Japanese in the Japan Public Health Center-Based Prospective Study for the Next Generation (JPHC-NEXT) Protocol Area

    PubMed Central

    Yokoyama, Yuta; Takachi, Ribeka; Ishihara, Junko; Ishii, Yuri; Sasazuki, Shizuka; Sawada, Norie; Shinozawa, Yurie; Tanaka, Junta; Kato, Erika; Kitamura, Kaori; Nakamura, Kazutoshi; Tsugane, Shoichiro

    2016-01-01

    Background Longitudinal epidemiological studies require both the periodic update of intake information via repeated dietary survey and the minimization of subject burden in responding to questionnaires. We developed a 66-item Food Frequency Questionnaire (short-FFQ) for the Japan Public Health Center-based prospective Study for the Next Generation (JPHC-NEXT) follow-up survey using major foods from the FFQ developed for the original JPHC Study. For the JPHC-NEXT baseline survey, we used a larger 172-item FFQ (long-FFQ), which was also derived from the JPHC-FFQ. We compared the validity of ranking individuals by levels of dietary consumption by these FFQs among residents of selected JPHC-NEXT study areas. Methods From 2012 to 2013, 240 men and women aged 40–74 years from five areas in the JPHC-NEXT protocol were asked to respond to the long-FFQ and provide 12-day weighed food records (WFR) as reference; 228 also completed the short-FFQ. Spearman’s correlation coefficients (CCs) between estimates from the FFQs and WFR were calculated and corrected for intra-individual variation of the WFR. Results Median CC values for energy and 53 nutrients for the short-FFQ for men and women were 0.46 and 0.44, respectively. Respective values for the long-FFQ were 0.50 and 0.43. Compared with the long-FFQ, cross-classification into exact plus adjacent quintiles with the short-FFQ ranged from 68% to 91% in men and 58% to 85% in women. Conclusions Similar to the long-FFQ, the short-FFQ provided reasonably valid measures for ranking middle-aged and elderly Japanese for many nutrients and food groups. The short-FFQ can be used in follow-up surveys in prospective cohort studies aimed at updating diet rank information. PMID:27064130

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

    USGS Publications Warehouse

    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 <2-mm fraction of each sample was analyzed for Al, 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

  14. A novel Smart Routing Protocol for remote health monitoring in Medical Wireless Networks.

    PubMed

    Sundararajan, T V P; Sumithra, M G; Maheswar, R

    2014-01-01

    In a Medical Wireless Network (MWN), sensors constantly monitor patient's physiological condition and movement. Inter-MWN communications are set up between the Patient Server and one or more Centralized Coordinators. However, MWNs require protocols with little energy consumption and the self-organizing attribute perceived in ad-hoc networks. The proposed Smart Routing Protocol (SRP) selects only the nodes with a higher residual energy and lower traffic density for routing. This approach enhances cooperation among the nodes of a Mobile Ad Hoc Network. Consequently, SRP produces better results than the existing protocols, namely Conditional Min-Max Battery Cost Routing, Min-Max Battery Cost Routing and AdHoc On-demand Distance Vector in terms of network parameters. The performance of the erstwhile schemes for routing protocols is evaluated using the network simulator Qualnet v 4.5.

  15. Protocol design for large-scale cross-sectional studies of sexual abuse and associated factors in individual sports: feasibility study in Swedish athletics.

    PubMed

    Timpka, Toomas; Janson, Staffan; Jacobsson, Jenny; Ekberg, Joakim; Dahlström, Örjan; Kowalski, Jan; Bargoria, Victor; Mountjoy, Margo; Svedin, Carl G

    2015-03-01

    To ensure health and well-being for their athletes, sports organizations must offer preventive measures against sexual abuse. The aim of this study was to design and evaluate feasibility of a research protocol for cross-sectional epidemiological studies of sexual abuse in athletics. Examination of the requirements on the study of sexual abuse in athletics was followed by iterated drafting of protocol specifications and formative evaluations. The feasibility of the resulting protocol was evaluated in a national-level study among elite athletics athletes (n = 507) in Sweden. The definition of sexual abuse, the ethical soundness of the protocol, reference populations and study of co-morbidity, and the means for athlete-level data collection were identified as particularly complex issues in the requirements analyses. The web-based survey defined by the protocol facilitates anonymous athlete self-reporting of data on exposure to sexual abuse. 198 athletes (39%) fully completed the feasibility survey. 89% (n = 177) reported that they agreed with that the questions in the survey were important, and 95% (n = 189) reported that they answered truthfully to all questions. Similarly, 91% (n = 180) reported that they did not agree with that the questions were unpleasant for them. However, 16% (n = 32) reported that they did not find the survey to be of personal value, and 12% (n = 23) reported that the survey had caused them to think about issues that they did not want to think about. Responding that participation was not personally gratifying was associated with training more hours (p = 0.01). There is a scarcity of research on the prevention of sexual abuse in individual sports. The present protocol should be regarded as a means to overcome this shortcoming in athletics. When implementing the protocol, it is necessary to encourage athlete compliance and to adapt the web-based survey to the particular infrastructural conditions in the sports setting at hand. Key points

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

    PubMed Central

    2010-01-01

    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. PMID:20487532

  17. Protocol for an exploration of knowledge sharing for improved discharge from a mental health ward

    PubMed Central

    Rowley, Emma; Wright, Nicola; Waring, Justin; Gregoriou, Kyri; Chopra, Arun

    2014-01-01

    Introduction Strategies to reduce hospital admissions for mental health service users have received vast amounts of attention, yet the transfer of care from hospital to the community has been ignored. The discharge process is complex, messy, disjointed and inefficient, relying on cross-agency and organisational working. Focusing on one acute mental health admission ward, we will investigate whether the discharge process for people with severe mental health problems can be enhanced through the creation, implementation and utilisation of a knowledge sharing proforma that is used on their admission to the ward. Methods and analysis The project uses qualitative interviews to understand the complex processes associated with being admitted and discharged from inpatient mental health wards. Practitioners will be asked to identify and map the relevant stakeholders involved in admission and discharge, and discuss any problems with the process. The study team will work with clinicians to develop a knowledge collection proforma, which will be piloted for 2 months. Qualitative interviews will be carried out to collect reflections on the experiences of using the tool, with data used for further refinement of the intervention. Baseline and repeat quantitative measures will be taken to illustrate any changes to length of stay and readmission rates achieved as a result of the study. Ethics and dissemination A key issue is that participants are able to comment frankly on something that is a core part of their work, without fear or reprise. It is equally important that all participants are offered the opportunity to develop and coproduce the knowledge collection proforma, in order that the intervention produced is fit for purpose and usable in the real world, away from a research environment. The study has received ethical approval from Nottingham University Business School ethics committee, and has all appropriate National Health Service research governance clearances. PMID

  18. Multimorbidity in primary care in Portugal (MM-PT): a cross-sectional three-phase observational study protocol

    PubMed Central

    Prazeres, Filipe; Santiago, Luiz

    2014-01-01

    Introduction Multimorbidity is defined as the co-occurrence of more than one chronic disease in one person without assigning an index disease. This rapidly increasing phenomenon markedly influences patients’ overall health, has major implications for effective provision of healthcare services and has a significant economic toll on individuals and society. Since Portugal is a country with a growing ageing population, a better understanding of the role of multimorbidity should be assessed. The aim of this study is to further the knowledge of the epidemiological factors associated with multimorbidity in Portugal, chiefly its prevalence and the health and social implications. Methods and analysis This study protocol describes a primary care nationwide three-phase study. The first phase is drawn to access the prevalence and patterns of multimorbidity. In the second phase, individual parameters are assessed, such as patients’ health-related quality of life, perceived family support and unmet health needs of patients with multimorbidity. The third and last phase of this study aims to characterise general practitioners’ knowledge, awareness and practices related to multimorbidity management. Ethics and dissemination The study will be conducted in accordance with the principles expressed in the Declaration of Helsinki. It has full approval from the Ethics Committee of the Faculty of Health Sciences, University of Beira Interior, and the Ethics Committee of the Central Health Region of Portugal. Study results will be published in peer-reviewed journals and presented at national and international conferences. PMID:24531449

  19. Development of patient decision support tools for motor neuron disease using stakeholder consultation: a study protocol

    PubMed Central

    Hogden, Anne; Greenfield, David; Caga, Jashelle; Cai, Xiongcai

    2016-01-01

    Introduction Motor neuron disease (MND) is a terminal, progressive, multisystem disorder. Well-timed decisions are key to effective symptom management. To date, there are few published decision support tools, also known as decision aids, to guide patients in making ongoing choices for symptom management and quality of life. This protocol is to develop and validate decision support tools for patients and families to use in conjunction with health professionals in MND multidisciplinary care. The tools will inform patients and families of the benefits and risks of each option, as well as the consequences of accepting or declining treatment. Methods and analysis The study is being conducted from June 2015 to May 2016, using a modified Delphi process. A 2-stage, 7-step process will be used to develop the tools, based on existing literature and stakeholder feedback. The first stage will be to develop the decision support tools, while the second stage will be to validate both the tools and the process used to develop them. Participants will form expert panels, to provide feedback on which the development and validation of the tools will be based. Participants will be drawn from patients with MND, family carers and health professionals, support association workers, peak body representatives, and MND and patient decision-making researchers. Ethics and dissemination Ethical approval for the study has been granted by Macquarie University Human Research Ethics Committee (HREC), approval number 5201500658. Knowledge translation will be conducted via publications, seminar and conference presentations to patients and families, health professionals and researchers. PMID:27053272

  20. The Emergency Public Relations Protocol: How to Work Effectively on Controversial Projects in an Academic Health Setting.

    PubMed

    Rosser, B R Simon; Kilian, Gunna; West, William G

    2013-03-01

    Certain research topics - including studies of sexual behavior, substance use, and HIV risk -- are more likely to be scrutinized by the media and groups opposed to this area of research. When studying topics that others might deem controversial, it is critical that researchers anticipate potential negative media events prior to their occurrence. By developing an Emergency Public Relations Protocol at the genesis of a study, researchers can identify and plan for events that might result in higher scrutiny. For each identified risk, a good protocol details procedures to enact before, during and after a media event. This manuscript offers recommendations for developing a protocol based on both Situational Crisis Communication Theory and our experience as an HIV prevention research group who recently experienced such an event. The need to have procedures in place to monitor and address social media is highlighted.

  1. The Emergency Public Relations Protocol: How to Work Effectively on Controversial Projects in an Academic Health Setting

    PubMed Central

    Rosser, B. R. Simon; Kilian, Gunna; West, William G.

    2012-01-01

    Certain research topics - including studies of sexual behavior, substance use, and HIV risk -- are more likely to be scrutinized by the media and groups opposed to this area of research. When studying topics that others might deem controversial, it is critical that researchers anticipate potential negative media events prior to their occurrence. By developing an Emergency Public Relations Protocol at the genesis of a study, researchers can identify and plan for events that might result in higher scrutiny. For each identified risk, a good protocol details procedures to enact before, during and after a media event. This manuscript offers recommendations for developing a protocol based on both Situational Crisis Communication Theory and our experience as an HIV prevention research group who recently experienced such an event. The need to have procedures in place to monitor and address social media is highlighted. PMID:23565067

  2. The Emergency Public Relations Protocol: How to Work Effectively on Controversial Projects in an Academic Health Setting.

    PubMed

    Rosser, B R Simon; Kilian, Gunna; West, William G

    2013-03-01

    Certain research topics - including studies of sexual behavior, substance use, and HIV risk -- are more likely to be scrutinized by the media and groups opposed to this area of research. When studying topics that others might deem controversial, it is critical that researchers anticipate potential negative media events prior to their occurrence. By developing an Emergency Public Relations Protocol at the genesis of a study, researchers can identify and plan for events that might result in higher scrutiny. For each identified risk, a good protocol details procedures to enact before, during and after a media event. This manuscript offers recommendations for developing a protocol based on both Situational Crisis Communication Theory and our experience as an HIV prevention research group who recently experienced such an event. The need to have procedures in place to monitor and address social media is highlighted. PMID:23565067

  3. Wikis and collaborative writing applications in health care: a scoping review protocol.

    PubMed

    Archambault, Patrick Michel; van de Belt, Tom H; Grajales Iii, Francisco J; Eysenbach, Gunther; Aubin, Karine; Gold, Irving; Gagnon, Marie-Pierre; Kuziemsky, Craig E; Turgeon, Alexis F; Poitras, Julien; Faber, Marjan J; Kremer, Jan A M; Heldoorn, Marcel; Bilodeau, Andrea; Légaré, France

    2012-04-11

    The rapid rise in the use of collaborative writing applications (eg, wikis, Google Documents, and Google Knol) has created the need for a systematic synthesis of the evidence of their impact as knowledge translation (KT) tools in the health care sector and for an inventory of the factors that affect their use. While researchers have conducted systematic reviews on a range of software-based information and communication technologies as well as other social media (eg, virtual communities of practice, virtual peer-to-peer communities, and electronic support groups), none have reviewed collaborative writing applications in the medical sector. The overarching goal of this project is to explore the depth and breadth of evidence for the use of collaborative writing applications in health care. Thus, the purposes of this scoping review will be to (1) map the literature on collaborative writing applications; (2) compare the applications' features; (3) describe the evidence of each application's positive and negative effects as a KT intervention in health care; (4) inventory and describe the barriers and facilitators that affect the applications' use; and (5) produce an action plan and a research agenda. A six-stage framework for scoping reviews will be used: (1) identifying the research question; (2) identifying relevant studies within the selected databases (using the EPPI-Reviewer software to classify the studies); (3) selecting studies (an iterative process in which two reviewers search the literature, refine the search strategy, and review articles for inclusion); (4) charting the data (using EPPI-Reviewer's data-charting form); (5) collating, summarizing, and reporting the results (performing a descriptive, numerical, and interpretive synthesis); and (6) consulting knowledge users during three planned meetings. Since this scoping review concerns the use of collaborative writing applications as KT interventions in health care, we will use the Knowledge to Action (KTA

  4. Health effects of training laypeople to deliver emergency care in underserviced populations: a systematic review protocol

    PubMed Central

    Orkin, Aaron M; Curran, Jeffrey D; Fortune, Melanie K; McArthur, Allison; Mew, Emma J; Ritchie, Stephen D; Van de Velde, Stijn; VanderBurgh, David

    2016-01-01

    Introduction The Disease Control Priorities Project recommends emergency care training for laypersons in low-resource settings, but evidence for these interventions has not yet been systematically reviewed. This review will identify the individual and community health effects of educating laypeople to deliver prehospital emergency care interventions in low-resource settings. Methods and analysis This systematic review addresses the following question: in underserviced populations and low-resource settings (P), does first aid or emergency care training or education for laypeople (I) confer any individual or community health benefit for emergency health conditions (O), in comparison with no training or other forms of education (C)? We restrict this review to studies reporting quantitatively measurable outcomes, and search 12 electronic bibliographic databases and grey literature sources. A team of expert content and methodology reviewers will conduct title and abstract screening and full-text review, using a custom-built online platform. Two investigators will independently extract methodological variables and outcomes related to patient-level morbidity and mortality and community-level effects on resilience or emergency care capacity. Two investigators will independently assess external validity, selection bias, performance bias, measurement bias, attrition bias and confounding. We will summarise the findings using a narrative approach to highlight similarities and differences between the gathered studies. Ethics and dissemination Formal ethical approval is not required. Results The results will be disseminated through a peer-reviewed publication and knowledge translation strategy. Review registration number CRD42014009685. PMID:27194315

  5. Study Guide in Health Economics.

    ERIC Educational Resources Information Center

    Dawson, George; Jablon, Bert

    Prepared to assist students at Empire State College in developing learning contracts for the study of the economics of health care delivery, this study guide discusses various aspects of the topic, suggests student projects, and provides an extensive bibliography. First, introductory material discusses the relationship of economics to health care…

  6. Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed. Methods/Design This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect. Discussion This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been

  7. Ethics in public health research: a research protocol to evaluate the effectiveness of public-private partnerships as a means to improve health and welfare systems worldwide.

    PubMed

    Barr, Donald A

    2007-01-01

    Public-private partnerships have become a common approach to health care problems worldwide. Many public-private partnerships were created during the late 1990s, but most were focused on specific diseases such as HIV/AIDS, tuberculosis, and malaria. Recently there has been enthusiasm for using public-private partnerships to improve the delivery of health and welfare services for a wider range of health problems, especially in developing countries. The success of public-private partnerships in this context appears to be mixed, and few data are available to evaluate their effectiveness. This analysis provides an overview of the history of health-related public-private partnerships during the past 20 years and describes a research protocol commissioned by the World Health Organization to evaluate the effectiveness of public-private partnerships in a research context.

  8. Association between obesity and depression in patients with diabetes mellitus type 2; a study protocol

    PubMed Central

    De la Cruz-Cano, Eduardo; Tovilla-Zarate, Carlos Alfonso; Reyes-Ramos, Emilio; Gonzalez-Castro, Thelma Beatriz; Juarez-Castro, Isela; López-Narváez, Maria Lilia; Fresan, Ana

    2015-01-01

    Background: Diabetes mellitus and depression are highly prevalent conditions throughout the world and have significant impact on health outcomes. It has been estimated that diabetes mellitus type 2 affects about 246 million people in the world; nevertheless, incidence varies among countries. There is evidence that depression is associated with a poor metabolic control in patients with type 2 diabetes mellitus that present other health problems (such as hypertension and obesity). The aim of this study protocol is to determine if obesity increases the risk for depression in patient with diabetes type 2. Methods: The analysis will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).The studies suitable for inclusion will be assessed by the Newcastle-Ottawa Scale (NOS) to determine their methodological quality. To identify the studies of interest, we will search on PubMed and EBSCO databases. We will use the following keyword combinations: "Diabetes Mellitus type 2 AND obesity AND depression", "depression AND Diabetes Mellitus type 2", "Diabetes Mellitus type 2 AND body mass index cross sectional study", "depression AND obesity cross-sectional study". Causes for exclusion will be publications that studied patients diagnosed with diabetes mellitus type 1; articles that focused on the treatment and complications of diabetes mellitus type 2; publications that have studied other clinical or psychiatric conditions (for instance, seizure disorder or history of schizophrenia, bipolar disorder, psychotic symptoms or dementia). Conclusion: The results of this study will form the basis for a better understanding of the association between obesity and depression in patients with diabetes mellitus type 2, and will allow development of prediction tools and better interventions. It is evident that several modifiable and non-modifiable risk factors play an important role in the pathogenesis of diabetes among population. Currently

  9. Developing the protocol for the evaluation of the health foundation's 'engaging with quality initiative' – an emergent approach

    PubMed Central

    Soper, Bryony; Buxton, Martin; Hanney, Stephen; Oortwijn, Wija; Scoggins, Amanda; Steel, Nick; Ling, Tom

    2008-01-01

    In 2004 a UK charity, The Health Foundation, established the 'Engaging with Quality Initiative' to explore and evaluate the benefits of engaging clinicians in quality improvement in healthcare. Eight projects run by professional bodies or specialist societies were commissioned in various areas of acute care. A developmental approach to the initiative was adopted, accompanied by a two level evaluation: eight project self-evaluations and a related external evaluation. This paper describes how the protocol for the external evaluation was developed. The challenges faced included large variation between and within the projects (in approach, scope and context, and in understanding of quality improvement), the need to support the project teams in their self-evaluations while retaining a necessary objectivity, and the difficulty of evaluating the moving target created by the developmental approach adopted in the initiative. An initial period to develop the evaluation protocol proved invaluable in helping us to explore these issues. PMID:18973650

  10. Long Working Hours and Subsequent Use of Psychotropic Medicine: A Study Protocol

    PubMed Central

    Albertsen, Karen

    2014-01-01

    Background Mental ill health is the most frequent cause of long-term sickness absence and disability retirement in Denmark. Some instances of mental ill health might be due to long working hours. A recent large cross-sectional study of a general working population in Norway found that not only “very much overtime”, but also “moderate overtime” (41-48 work hours/week) was significantly associated with increased levels of both anxiety and depression. These findings have not been sufficiently confirmed in longitudinal studies. Objective The objective of the study is to give a detailed plan for a research project aimed at investigating the possibility of a prospective association between weekly working hours and use of psychotropic medicine in the general working population of Denmark. Methods People from the general working population of Denmark have been surveyed, at various occasions in the time period 1995-2010, and interviewed about their work environment. The present study will link interview data from these surveys to national registers covering all inhabitants of Denmark. The participants will be followed for the first occurrence of redeemed prescriptions for psychotropic medicine. Poisson regression will be used to analyze incidence rates as a function of weekly working hours (32-40; 41-48; > 48 hours/week). The analyses will be controlled for gender, age, sample, shift work, and socioeconomic status. According to our feasibility studies, the statistical power is sufficient and the exposure is stable enough to make the study worth the while. Results The publication of the present study protocol ends the design phase of the project. In the next phase, the questionnaire data will be forwarded to Statistics Denmark where they will be linked to data on deaths, migrations, socioeconomic status, and redeemed prescriptions for psychotropic medication. We expect the analysis to be completed by the end of 2014 and the results to be published mid 2015

  11. LATEX sensitization in elderly: allergological study and diagnostic protocol

    PubMed Central

    2014-01-01

    Background The prevalence of latex allergy varies according to the population studied from 3% to 64%. No data exist in the present literature about elderly people because they were not considered among populations at risk. We report a retrospective observational study of 88 elderly patients of our centre of Dermatology and Allergology at Policlinico Umberto I, University of Rome, Sapienza. Results First and second level diagnostic tests showed latex positivity in 11,4% of patients studied for latex allergy in the elderly population. Conclusions Our study demonstrates a prevalence of elderly-latex sensitization of 11,4%, showing that allergy to latex is a growing disease that can occur at any age. So, we propose these patients as an additional risk category for latex allergy. PMID:24822075

  12. Case-control study on analgesics and nephropathy (SAN): protocol

    PubMed Central

    Heinemann, Lothar AJ; Garbe, Edeltraut; Lewis, Michael; van der Woude, Fokko; Graf, Helmut

    2005-01-01

    Background The association between intake of non-phenacetin-containing analgesics and the occurrence of chronic renal failure is still controversially discussed. A new epidemiologic study was planned and conducted in Germany and Austria. Methods/design The objective of the international, multicenter case-control study was to evaluate the association between end-stage renal disease (ESRD) and use of non-phenacetin-containing analgesics with particular emphasis on combined formulations. A targeted sample of 1000 new (incident) dialysis patients, aged less than 50 years, was planned to recruit between January 1, 2001 and December 31, 2004. The age limit was chosen to avoid contamination of the study population with phenacetin-containing analgesics to the extent possible. Four control subjects per ESRD case, matched by age, sex, and region were selected from the population living in the region the case came from. Lifetime exposure to analgesics and potential renal risk factors were recorded in a single face-to-face interview. A set of aids was introduced to reinforce the memory of study participants. A standardized, pre-tested interview questionnaire (participants), a medical documentation sheet (physicians in dialysis centres), a logbook for all activities (dialysis centres) were used to collect the necessary data. Quality management consisted of the standardized procedures, (re-) training and supervision of interviewers, regular checks of all incoming data for completeness and plausibility. The study is scientifically independent and governed by a international Scientific Advisory Committee that bridged the gap between the sponsoring companies and the investigators. Also other advisory groups assisted the managing committee of the study. All relevant German and Austrian nephrological associations supported the study, and the study design was carefully reviewed and approved by the Kidney Foundation of Germany. Discussion The study is expected to answer the main

  13. Tobacco control policies and perinatal and child health: a systematic review and meta-analysis protocol

    PubMed Central

    Been, Jasper V; Mackenbach, Johan P; Millett, Christopher; Basu, Sanjay; Sheikh, Aziz

    2015-01-01

    Introduction Children experience considerable morbidity and mortality due to tobacco smoke exposure. Tobacco control policies may benefit child health by reducing this exposure. We aim to comprehensively assess the effects of the range of tobacco control policies advocated by the WHO on perinatal and child health. Methods and analysis We will systematically search 19 electronic literature databases (from inception) for published studies, and the WHO International Clinical Trials Registry Platform for unpublished studies. Additional work will be identified via handsearching references and citations, and through consulting an international panel of experts. No language restrictions will apply. Following Cochrane Effective Practice and Organisation of Care (EPOC) guidelines, randomised and clinical controlled trials, controlled before-and-after studies, and interrupted time series designs, are eligible. Studies of interest will assess the impact of any of the WHO-advocated tobacco control policies contained in the MPOWER acronym (except ‘Monitoring tobacco use’) on at least one outcome of interest among children aged 0–12 years. The primary outcomes are: perinatal mortality, preterm birth, asthma exacerbations requiring hospital attendance and respiratory infections requiring hospital attendance. Data will be extracted using customised forms and authors will be contacted to obtain missing information. Risk of bias will be assessed using EPOC criteria. Findings will be reported in narrative and tabular form. Between-study heterogeneity will be assessed clinically and statistically using I2. If appropriate and possible, random-effects meta-analysis will be conducted for each unique combination of intervention and outcome. Subgroup analyses will be performed to assess the influence of the comprehensiveness of each policy, and to explore the impact of each policy according to socioeconomic status. Ethics and dissemination No ethical assessment is necessary as we

  14. Thyroid and Pregnancy in Tehran, Iran: Objectives and Study Protocol

    PubMed Central

    Nazarpour, Sima; Ramezani Tehrani, Fahimeh; Simbar, Masoumeh; Tohidi, Maryam; Azizi, Fereidoun

    2016-01-01

    Background Thyroid dysfunction is the second most common endocrine disease in females of reproductive age. There are controversial data on the adverse effect of subclinical thyroid dysfunctions on adverse feto-maternal outcomes. Objectives The current study aimed to identify the prevalence of thyroid dysfunction during pregnancy and to assess the effectiveness of treatment with levothyroxine on pregnancy outcomes of females with thyroid autoimmunity with or without subclinical thyroid dysfunction in Tehran, Iran. Patients and Methods The study encompassed two phases: 1) a population based cross sectional study using a cluster sampling method that screened first trimester pregnant females for thyroid disorders, 2) a double-blind randomized clinical trial to determine the effectiveness of levothyroxine on adverse pregnancy outcomes in females with thyroid autoimmunity with or without subclinical thyroid dysfunction. Pregnant females were assessed at their first prenatal visit for serum TSH, T4, T-uptake, TPOAb and urinary iodine following which they were classified as: 1) normal, 2) subclinical TPOAb negative and 3) subclinical/euthyroid TPOAb positive. Females in groups two and three were randomly divided into two groups: group A was treated with levothyroxine (LT4), and group B did not receive any treatment. There was a follow-up program for participants and rates of adverse pregnancy outcomes in the treated and untreated groups were measured. Results Results of the study provided reliable information regarding the prevalence of thyroid dysfunction among females in Tehran using universal thyroid screening, along with identification of the iodine status of their community. The study aimed to determine whether LT4 treatment exerts beneficial effects in females without overt thyroid dysfunction. PMID:27279833

  15. Acupuncture for acute stroke: study protocol for a multicenter, randomized, controlled trial

    PubMed Central

    2014-01-01

    Background Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years. However, previous research has not yet shown that acupuncture is effective as a stroke treatment. We report a protocol for a multicenter, randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke. Methods/Design In a prospective trial involving three hospitals in the Zhejiang Province (China) 250 patients with a recent (less than 1 week previous) episode of ischemic stroke will be included. Patients will be randomized into two groups: an acupuncture group given scalp acupuncture and electroacupuncture, and a control group given no acupuncture. Eighteen treatment sessions will be performed over a three-week period. The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one, three, and four-week follow-up. Secondary outcome measures will be: 1) the Fugl-Meyer assessment scale for motor function; 2) the mini-mental state examination and Montreal cognitive assessment for cognitive function; 3) the video-fluoroscopic swallowing study for swallowing ability; and 4) the incidence of adverse events. Discussion This trial is expected to clarify whether or not acupuncture is effective for acute stroke. It will also show if acupuncture can improve motor, cognitive, or swallowing function. Trial registration Chinese Clinical Trial Registry ChiCTR-TRC-12001971. PMID:24908241

  16. Patient involvement in research priorities (PIRE): a study protocol

    PubMed Central

    Jarden, Mary

    2016-01-01

    Introduction Patient involvement in healthcare has expanded from the clinical practice setting to include collaboration during the research process. There has been a growing international interest in patient and public involvement in setting research priorities to reduce the risk of discrepancy between what patients with cancer and their relatives experience as important unanswered questions and those which are actually researched. This study aims to challenge the conventional research process by inviting patients with life-threatening cancer (primary malignant brain tumours or acute leukaemia), relatives and patient organisations to join forces with clinical specialists and researchers to identify, discuss and prioritise supportive care and rehabilitation issues in future research. Methods and analysis This is an exploratory qualitative study comprising two sets of three focus group interviews (FGIs): one set for primary malignant brain tumours and the other for acute leukaemia. Separate FGIs will be carried out with patients and relatives including representation from patient organisations and clinical specialists to identify important unanswered questions and research topics within each group. The FGIs will be video/audio recorded, transcribed and thematically analysed. This study will contribute to a patient-centred research agenda that captures issues that patients, their relatives, clinical specialists and researchers consider important. Ethics and dissemination The study is registered at the Danish Data Protection Agency (number: 2012-58-0004) and the Scientific Ethics Review Committee of the Capital Region of Denmark (number: H-15001485). Papers will be published describing the methods applied and the supportive care and rehabilitation issues that are identified as important for future research. Trial registration number ISRCTN57131943; Pre-results. PMID:27221126

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

    PubMed Central

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

    2016-01-01

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

  18. Indoor air quality investigation protocols

    SciTech Connect

    Greene, R.E.; Williams, P.L.

    1996-10-01

    Over the past 10 to 15 years, an increasing number of complaints about discomfort and health effects related to indoor air quality (IAQ) have been reported. The increase in complaints has been accompanied by an increase in requests for IAQ investigations. This study presents an overview of the many IAQ investigation protocols published since 1984. For analysis, the protocols are divided into four categories: solution-oriented, building diagnostics, industrial hygiene, and epidemiology. In general, the protocols begin with general observations, proceed to collect more specific data as indicated, and end with conclusions and recommendations. A generic IAQ protocol is presented that incorporates the common aspects of the various protocols. All of the current protocols place heavy emphasis on the ventilation system during the investigation. A major problem affecting all of the current protocols is the lack of generally accepted IAQ standards. IN addition, the use of questionnaires, occupant interviews, and personal diaries (as well as the point in the investigation at which they are administered) differs among the protocols. Medical evaluations and verification procedures also differ among the protocols.

  19. Radiation Doses of Various CT Protocols: a Multicenter Longitudinal Observation Study

    PubMed Central

    2016-01-01

    Emerging concerns regarding the hazard from medical radiation including CT examinations has been suggested. The purpose of this study was to observe the longitudinal changes of CT radiation doses of various CT protocols and to estimate the long-term efforts of supervising radiologists to reduce medical radiation. Radiation dose data from 11 representative CT protocols were collected from 12 hospitals. Attending radiologists had collected CT radiation dose data in two time points, 2007 and 2010. They collected the volume CT dose index (CTDIvol) of each phase, number of phases, dose length product (DLP) of each phase, and types of scanned CT machines. From the collected data, total DLP and effective dose (ED) were calculated. CTDIvol, total DLP, and ED of 2007 and 2010 were compared according to CT protocols, CT machine type, and hospital. During the three years, CTDIvol had significantly decreased, except for dynamic CT of the liver. Total DLP and ED were significantly decreased in all 11 protocols. The decrement was more evident in newer CT scanners. However, there was substantial variability of changes of ED during the three years according to hospitals. Although there was variability according to protocols, machines, and hospital, CT radiation doses were decreased during the 3 years. This study showed the effects of decreased CT radiation dose by efforts of radiologists and medical society. PMID:26908984

  20. The Japan Morning Surge-1 (JMS-1) study: protocol description.

    PubMed

    Ishikawa, Joji; Hoshide, Satoshi; Shibasaki, Seiichi; Matsui, Yoshio; Kabutoya, Tomoyuki; Eguchi, Kazuo; Ishikawa, Shizukiyo; Pickering, Thomas G; Shimada, Kazuyuki; Kario, Kazuomi

    2006-03-01

    Morning blood pressure is reported to be more closely related to hypertensive organ damages such as left ventricular mass index, microalbuminuria and silent cerebral infarcts, than blood pressure at other times of the day. Morning blood pressure may play an important role in the pathogenesis of hypertensive target organ damage. Increased sympathetic nerve activity is reported to be one of the mechanisms of morning hypertension; however, there are no available data that show whether strict home blood pressure control, especially in the morning period, can reduce target organ damage. The Japan Morning Surge-1 (JMS-1) study includes hypertensive outpatients with elevated morning systolic blood pressure (>or=135 mmHg) as assessed by self-measured blood pressure monitoring at home. All enrolled patients are under stable antihypertensive medication status. Exclusion criteria are arrhythmia, chronic inflammatory disease, and taking alpha-blockers or beta-blockers. The target number of patients to be enrolled in the JMS-1 study is 600, and the aim is to evaluate differences in the markers of hypertensive target organ damage, such as brain natriuretic peptide and the urinary albumin excretion/creatinine ratio. All of the patients are randomized to an experimental group or a control group, with randomization to be carried out by telephone interviews with the patients' physicians. In the experimental group, patients begin taking additional antihypertensive medication just before going to bed. This consists of doxazosin 1 mg/day, which then is increased to 2 mg/day and 4 mg/day, with a beta-blocker added after a 1-month interval until the morning systolic blood pressure is controlled to less than 135 mmHg. Patients in the control group continue the treatment they are receiving at the enrollment for 6 months. Blood pressure levels, adverse effects, and hypertensive target organ damage before and after the study are evaluated. In the JMS-1 study, we will evaluate whether strict

  1. Agricultural Health Study

    Cancer.gov

    A prospective cohort study of commercial pesticide applicators, farmers and farmers' spouses in Iowa and North Carolina conducted in collaboration between the NIH and the U.S. Evironmental Protection Agency

  2. The Engagement Interview Protocol (EIP): improving the acceptance of mental health treatment among Chinese immigrants

    PubMed Central

    Yeung, Albert; Trinh, Nhi-Ha T.; Chang, Trina E.; Fava, Maurizio

    2014-01-01

    Many depressed Chinese immigrants are unfamiliar with Western psychiatric terminology and have high levels of stigma toward psychiatric illnesses, making it difficult to engage them into psychiatric treatment. We have designed the Engagement Interview Protocol (EIP), a semi-standardized protocol that incorporates cultural components to a standard psychiatric evaluation. The EIP elicits patients’ narratives and uses anthropological questions to explore patients’ illness beliefs, which are integrated with patients’ information on medical and psychiatric history, psychosocial background and mental status examination so that treatment options can be negotiated in a culturally sensitive manner. In our field testing on depressed Chinese immigrants, the EIP model was found to be a practical tool that can be completed within the allotted one-hour time frame and was highly effective in facilitating the enrollment of patients in treatment for depression. The EIP is a concise, time-effective, user-friendly protocol that can be used both in research and real-world clinical settings with diverse patient populations. PMID:25076983

  3. Human Resource Information Systems in Health Care: Protocol for a Systematic Review

    PubMed Central

    Tursunbayeva, Aizhan; Bunduchi, Raluca; Franco, Massimo

    2015-01-01

    Background Compared with the eHealth literature as a whole, there has been relatively little published research on the use and impact of information and communication technologies (ICTs) designed to support business functions within health organizations. Human resource information systems (HRISs) have the potential to improve organizational efficiency and effectiveness by facilitating workforce planning, financial and operational administration, staff training, and management analytics. However, the evidence base regarding HRIS in health care is widely distributed across disciplinary boundaries and previous reviews have been somewhat limited in scope. This rigorous systematic review will identify, appraise, and synthesize existing international research on the implementation and impacts of HRIS in health organizations, to provide insights and recommendations that may guide future purchasers, commissioners, implementers, evaluators, and users of such systems. Objective The objectives of this review are threefold: (1) to determine the prevalence and scope of existing research and evaluation pertaining to HRIS in health organizations; (2) to analyze, classify, and synthesize existing evidence on the processes and impacts of HRIS development, implementation, and adoption; and (3) to generate recommendations for HRIS research, practice, and policy, with reference to the needs of different stakeholders and communities of practice. Methods A high-level scoping review was first undertaken to inform a draft search strategy, which was refined through several cycles of piloting and iteration to optimize its sensitivity and specificity. This was used by the first author, with the help of a medical librarian, to search international electronic databases indexing medical, business, ICT, and multi-disciplinary research. Sources of gray literature and reference lists of included studies were also searched. There were no restrictions on language or publication year. Two reviewers

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

    PubMed Central

    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

  5. Learning from positively deviant wards to improve patient safety: an observational study protocol

    PubMed Central

    Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Lawton, Rebecca

    2015-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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

  6. The effect of a low radiation CT protocol on accuracy of CT guided implant migration measurement: A cadaver study.

    PubMed

    Boettner, Friedrich; Sculco, Peter K; Lipman, Joseph; Saboeiro, Gregory; Renner, Lisa; Faschingbauer, Martin

    2016-04-01

    The current study compared the impact of low radiation CT protocols on the accuracy, repeatability, and inter- and intra-observer variability of implant migration studies in total hip arthroplasty. Two total hip replacements were performed in two human cadavers and six tantalum beads were inserted into the femur similar to radiostereometric analysis. Six different 28 mm heads (-3 mm, 0 mm, 2.5 mm, 5.0 mm, 7.5 mm, and 10 mm) were added to simulate five reproducible translations (maximum total point migration) of the center of the head. Three CT scans with varying levels of radiation were performed for each head position. The effective dose (mSv) was 3.8 mSv for Protocol A (standard protocol), 0.7 mSv for Protocol B and 1.6 mSv for Protocol C. Implant migration was measured in a 3-D analysis software (Geomagic Studio 7). The accuracy was 0.16 mm for CT Protocol A, 0.13 mm for Protocol B and 0.14 mm for Protocol C; The repeatability was 0.22 mm for CT Protocol A, 0.18 mm for Protocol B and 0.20 mm for Protocol C; ICC for inter observer reliability was 0.89, intra observer reliability was 0.95. The difference in accuracy between standard protocol A and the two low radiation protocols (B, C) was less than 0.05 mm. The accuracy, inter- and intra-observer reliability of all three CT protocols is comparable to radiostereometric analysis. Reducing the CT radiation exposure to numbers similar to an AP Pelvis radiograph (0.7 mSv protocol B) does not affect the accuracy of implant migration measurements. PMID:26425921

  7. The effect of a low radiation CT protocol on accuracy of CT guided implant migration measurement: A cadaver study.

    PubMed

    Boettner, Friedrich; Sculco, Peter K; Lipman, Joseph; Saboeiro, Gregory; Renner, Lisa; Faschingbauer, Martin

    2016-04-01

    The current study compared the impact of low radiation CT protocols on the accuracy, repeatability, and inter- and intra-observer variability of implant migration studies in total hip arthroplasty. Two total hip replacements were performed in two human cadavers and six tantalum beads were inserted into the femur similar to radiostereometric analysis. Six different 28 mm heads (-3 mm, 0 mm, 2.5 mm, 5.0 mm, 7.5 mm, and 10 mm) were added to simulate five reproducible translations (maximum total point migration) of the center of the head. Three CT scans with varying levels of radiation were performed for each head position. The effective dose (mSv) was 3.8 mSv for Protocol A (standard protocol), 0.7 mSv for Protocol B and 1.6 mSv for Protocol C. Implant migration was measured in a 3-D analysis software (Geomagic Studio 7). The accuracy was 0.16 mm for CT Protocol A, 0.13 mm for Protocol B and 0.14 mm for Protocol C; The repeatability was 0.22 mm for CT Protocol A, 0.18 mm for Protocol B and 0.20 mm for Protocol C; ICC for inter observer reliability was 0.89, intra observer reliability was 0.95. The difference in accuracy between standard protocol A and the two low radiation protocols (B, C) was less than 0.05 mm. The accuracy, inter- and intra-observer reliability of all three CT protocols is comparable to radiostereometric analysis. Reducing the CT radiation exposure to numbers similar to an AP Pelvis radiograph (0.7 mSv protocol B) does not affect the accuracy of implant migration measurements.

  8. Do sugar-sweetened beverages cause adverse health outcomes in adults? A systematic review protocol

    PubMed Central

    2014-01-01

    Background Chronic diseases, such as cardiovascular disease and type 2 diabetes, impose significant burden to public health. Most chronic diseases are associated with underlying preventable risk factors, such as elevated blood pressure, blood glucose, and lipids, physical inactivity, excessive sedentary behaviours, overweight and obesity, and tobacco usage. Sugar-sweetened beverages are known to be significant sources of additional caloric intake, and given recent attention to their contribution in the development of chronic diseases, a systematic review is warranted. We will assess whether the consumption of sugar-sweetened beverages in adults is associated with adverse health outcomes and what the potential moderating factors are. Methods/Design Of interest are studies addressing sugar-sweetened beverage consumption, taking a broad perspective. Both direct consumption studies as well as those evaluating interventions that influence consumption (e.g. school policy, educational) will be relevant. Non-specific or multi-faceted behavioural, educational, or policy interventions may also be included subject to the level of evidence that exists for the other interventions/exposures. Comparisons of interest and endpoints of interest are pre-specified. We will include randomized controlled trials, controlled clinical trials, interrupted time series studies, controlled before-after studies, prospective and retrospective comparative cohort studies, case-control studies, and nested case-control designs. The MEDLINE®, Embase, The Cochrane Library, CINAHL, ERIC, and PsycINFO® databases and grey literature sources will be searched. The processes for selecting studies, abstracting data, and resolving conflicts are described. We will assess risk of bias using design-specific tools. To determine sets of confounding variables that should be adjusted for, we have developed causal directed acyclic graphs and will use those to inform our risk of bias assessments. Meta-analysis will

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

    PubMed Central

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

    2014-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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

  10. Improving adherence to web-based cessation programs: a randomized controlled trial study protocol

    PubMed Central

    2013-01-01

    Background Reducing smoking prevalence is a public health priority that can save more lives and money than almost any other known preventive intervention. Internet interventions have the potential for enormous public health impact given their broad reach and effectiveness. However, most users engage only minimally with even the best designed websites, diminishing their impact due to an insufficient ‘dose’. Two approaches to improve adherence to Internet cessation programs are integrating smokers into an online social network and providing free nicotine replacement therapy (NRT). Active participation in online communities is associated with higher rates of cessation. Integrating smokers into an online social network can increase support and may also increase utilization of cessation tools and NRT. Removing barriers to NRT may increase uptake and adherence, and may also increase use of online cessation tools as smokers look for information and support while quitting. The combination of both strategies may exert the most powerful effects on adherence compared to either strategy alone. Methods/Design This study compares the efficacy of a smoking cessation website (WEB) alone and in conjunction with free NRT and a social network (SN) protocol designed to integrate participants into the online community. Using a 2 (SN, no SN) x 2 (NRT, no NRT) randomized, controlled factorial design with repeated measures at baseline, 3 months, and 9 months, this study will recruit N = 4,000 new members of an internet cessation program and randomize them to: 1) WEB, 2) WEB + SN, 3) WEB + NRT, or 4) WEB + SN + NRT. Hypotheses are that all interventions will outperform WEB and that WEB + SN + NRT will outperform WEB + NRT and WEB + SN on 30-day point prevalence abstinence at 9 months. Exploratory analyses will examine theory-driven hypotheses about the mediators and moderators of outcome. Discussion Addressing adherence in internet cessation programs is critical and timely to leverage

  11. Factors affecting adoption, implementation fidelity, and sustainability of the Redesigned Community Health Fund in Tanzania: a mixed methods protocol for process evaluation in the Dodoma region

    PubMed Central

    Kalolo, Albino; Radermacher, Ralf; Stoermer, Manfred; Meshack, Menoris; De Allegri, Manuela

    2015-01-01

    Background Despite the implementation of various initiatives to address low enrollment in voluntary micro health insurance (MHI) schemes in sub-Saharan Africa, the problem of low enrollment remains unresolved. The lack of process evaluations of such interventions makes it difficult to ascertain whether their poor results are because of design failures or implementation weaknesses. Objective In this paper, we describe a process evaluation protocol aimed at opening the ‘black box’ to evaluate the implementation processes of the Redesigned Community Health Fund (CHF) program in the Dodoma region of Tanzania. Design The study employs a cross-sectional mixed methods design and is being carried out 3 years after the launch of the Redesigned CHF program. The study is grounded in a conceptual framework which rests on the Diffusion of Innovation Theory and the Implementation Fidelity Framework. The study utilizes a mixture of quantitative and qualitative data collection tools (questionnaires, focus group discussions, in-depth interviews, and document review), and aligns the evaluation to the Theory of Intervention developed by our team. Quantitative data will be used to measure program adoption, implementation fidelity, and their moderating factors. Qualitative data will be used to explore the responses of stakeholders to the intervention, contextual factors, and moderators of adoption, implementation fidelity, and sustainability. Discussion This protocol describes a systematic process evaluation in relation to the implementation of a reformed MHI. We trust that the theoretical approaches and methodologies described in our protocol may be useful to inform the design of future process evaluations focused on the assessment of complex interventions, such as MHI schemes. PMID:26679408

  12. Health inequity in access to bariatric surgery: a protocol for a systematic review

    PubMed Central

    2014-01-01

    Background Bariatric surgery is the only weight-loss treatment available that results in both sustained weight loss and improvements of obesity-related comorbidities. Individuals who meet the eligibility criteria for bariatric surgery are generally older, come from racial or ethnic minorities, are economically disadvantaged, and have low levels of education. However, the population who actually receives bariatric surgery does not reflect the individuals who need it the most. The objective is to conduct a systematic review of the literature exploring the inequities to the access of bariatric surgery. Methods/Design EMBASE and Medline databases will be searched for observational studies that compared at least one of the PROGRESS-PLUS sociodemographic characteristics of patients eligible for bariatric surgery to those who actually received the procedure. Articles published in the year 1980 to present with no language restrictions will be included. For inclusion, studies must only include adults (≥18 years old) who meet National Institutes of Health (NIH) eligibility criteria for bariatric surgery defined as having either (1) a body mass index (BMI) of 40 kg/m2 or greater; or (2) BMI of 35 kg/m2 or greater with significant weight-related comorbidities. Eligible interventions will include malabsorptive, restrictive, and mixed bariatric procedures. Discussion There appears to be inequities in access to bariatric surgery. In order to resolve the health inequity in the treatment of obesity, a synthesis of the literature is needed to explore and identify barriers to accessing bariatric surgery. It is anticipated that the results from this systematic review will have important implications for advancing solutions to minimize inequities in the utilization of bariatric surgery. http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004920. PMID:24559394

  13. 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

    ERIC Educational Resources Information Center

    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…

  14. From public health to international law: possible protocols for inclusion in the Framework Convention on Tobacco Control.

    PubMed Central

    Joossens, L.

    2000-01-01

    Faced with a difficult business environment in the United States and the falling demand for cigarettes in industrialized countries, multinational tobacco companies have been competing fiercely to expand their sales in developing countries. Because of the worldwide threat posed by smoking to health and the emphasis being placed by international tobacco companies on marketing in developing countries, an international regulatory strategy, such as the WHO proposed Framework Convention on Tobacco Control, is needed. This review describes from a public health perspective the possible scope and key considerations of protocols that should be included in the convention. The key international areas that should be considered in tobacco control are: prices, smuggling; tax-free tobacco products; advertising and sponsorship; the Internet; testing methods; package design and labelling; agriculture; and information sharing. PMID:10994267

  15. From public health to international law: possible protocols for inclusion in the Framework Convention on Tobacco Control.

    PubMed

    Joossens, L

    2000-01-01

    Faced with a difficult business environment in the United States and the falling demand for cigarettes in industrialized countries, multinational tobacco companies have been competing fiercely to expand their sales in developing countries. Because of the worldwide threat posed by smoking to health and the emphasis being placed by international tobacco companies on marketing in developing countries, an international regulatory strategy, such as the WHO proposed Framework Convention on Tobacco Control, is needed. This review describes from a public health perspective the possible scope and key considerations of protocols that should be included in the convention. The key international areas that should be considered in tobacco control are: prices, smuggling; tax-free tobacco products; advertising and sponsorship; the Internet; testing methods; package design and labelling; agriculture; and information sharing.

  16. Evaluation of Heparin Anticoagulation Protocols in Post–Renal Transplant Recipients (EHAP-PoRT Study)

    PubMed Central

    Ng, Joan Chung Yan; Leung, Marianna; Landsberg, David

    2016-01-01

    Background: Disturbances in hemostasis are common among renal transplant recipients. Because of the risk of thromboembolism and graft loss after transplant, a prophylactic heparin protocol was implemented at St Paul’s Hospital in Vancouver, British Columbia, in 2011. Therapeutic heparin is sometimes prescribed perioperatively for patients with preexisting prothrombotic conditions. There is currently limited literature on the safety and efficacy of heparin use in the early postoperative period. Objectives: The primary objectives were to document, for patients who underwent renal transplant, the incidence of major bleeding and of thrombosis in those receiving therapeutic heparin, prophylactic heparin, and no heparin anticoagulation in the early postoperative period and to compare these rates for the latter 2 groups. The secondary objectives included a comparison of the risk factors associated with major bleeding and thrombosis. Methods: Adult patients who received a renal transplant at St Paul’s Hospital between January 2008 and July 2013 were included in this retrospective cohort study. Electronic health records and databases were used to divide patients into the 3 heparin-use cohorts, to identify cases of major bleeding and thrombosis, and to characterize patients and events. The Fisher exact test was used for the primary outcome analysis, and descriptive statistics were used for all other outcomes. Results: A total of 547 patients were included in the analysis. Major bleeding was observed in 6 (46%) of the 13 patients who received therapeutic heparin; no cases of thrombosis occurred in these patients. Major bleeding occurred in 8 (3.0%) of the 266 patients who received prophylactic heparin and 9 (3.4%) of the 268 who received no heparin (p > 0.99). Thrombosis occurred in 1 (0.4%) and 3 (1.1%) of these patients, respectively (p = 0.62). Major bleeding occurred more frequently among patients with a low-target heparin protocol, but 61% of values for partial

  17. Western Australian Public Opinions of a Minimum Pricing Policy for Alcohol: Study Protocol

    PubMed Central

    Keatley, David A; Daube, Mike; Hardcastle, Sarah J

    2015-01-01

    Background Excessive alcohol consumption has significant adverse economic, social, and health outcomes. Recent estimates suggest that the annual economic costs of alcohol in Australia are up to AUD $36 billion. Policies influencing price have been demonstrated to be very effective in reducing alcohol consumption and alcohol-related harms. Interest in minimum pricing has gained traction in recent years. However, there has been little research investigating the level of support for the public interest case of minimum pricing in Australia. Objective This article describes protocol for a study exploring Western Australian (WA) public knowledge, understanding, and reaction to a proposed minimum price policy per standard drink. Methods The study will employ a qualitative methodological design. Participants will be recruited from a wide variety of backgrounds, including ethnic minorities, blue and white collar workers, unemployed, students, and elderly/retired populations to participate in focus groups. Focus group participants will be asked about their knowledge of, and initial reactions to, the proposed policy and encouraged to discuss how such a proposal may affect their own alcohol use and alcohol consumption at the population level. Participants will also be asked to discuss potential avenues for increasing acceptability of the policy. The focus groups will adopt a semi-structured, open-ended approach guided by a question schedule. The schedule will be based on feedback from pilot samples, previous research, and a steering group comprising experts in alcohol policy and pricing. Results The study is expected to take approximately 14 months to complete. Conclusions The findings will be of considerable interest and relevance to government officials, policy makers, researchers, advocacy groups, alcohol retail and licensed establishments and organizations, city and town planners, police, and other stakeholder organizations. PMID:26582408

  18. Proposition for a protocol for anatomical studies on collection specimens by magnetic resonance imaging.

    PubMed

    Chanet, Bruno; Guintard, Claude

    2012-01-01

    Magnetic resonance imaging (MRI) examinations for anatomical studies on collection specimens are becoming more and more frequent. As the presence of metallic objects within the specimens can disturb the acquisition of images and damage both specimens and materials, a simple protocol using radiographs is here proposed to detect these objects in collection specimens before conducting an MRI examination.

  19. Delivery of rural and remote health care via a broadband Internet Protocol network - views of potential users.

    PubMed

    Jennett, P; Yeo, M; Scott, R; Hebert, M; Teo, W

    2005-01-01

    We asked the views of potential users of a proposed Canadian broadband Internet Protocol (IP) network for health, the Alberta SuperNet. The three user groups were drawn from the public, provider and private sectors. In all, 35 health-sector participants were selected (17 government, nine health-care organizations, five providers/practitioners and four private sector). The questionnaire was Web-based, semistructured and self-administered. It consisted of four major areas: value, readiness, effect on usual care and limitations. A total of 28 (80%) individuals responded to the questionnaire: 21 (81%) were from the public sector (three provincial, nine regional and nine organizational), three (60%) were from the provider sector and four (100%) were from the private sector. Overall, the items related to health services and health human resources were considered to be the most valuable to rural communities. Respondents identified the expansion of telehealth services as the most important, except those from the private sector, who ranked this a close second. The health system's move to the use of electronic health records was ranked second in importance by all respondents. The private-sector respondents viewed all user groups to be generally less ready (mean score 2.5 on a seven-point scale from 1 = not ready to 7 = ready), while the public-sector respondents were the most optimistic (mean score 4.0). Specific socioeconomic impact data were limited. The top-ranked disadvantage of the 10 suggested was that 'Changes in health-service delivery practices and/or processes will be required'. PMID:16356317

  20. Population health needs beyond ratifying the Kyoto Protocol: a look at occupational deprivation.

    PubMed

    Pereira, R B

    2008-01-01

    The dramatic impact of climate change is physically and economically affecting the world, a consequence of neglecting scientific information known since the 1960s and 1970s. International discussion has focused on the needs of the physical environment and general health concerns (such addressing greenhouse gas production and population health issues); however, little acknowledgement has yet been made of local human issues, such as the effect of climate change on the mental health of those in rural communities. This commentary takes an occupational science perspective to describe new ways of classifying potential mental health problems associated with climate change and its impact on the rural environment. It challenges policy makers to take a proactive approach to addressing the current impacts of climate change on the future mental health of individuals in rural communities.

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

    PubMed

    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.

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

    PubMed Central

    2011-01-01

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

  3. Do sugar-sweetened beverages cause adverse health outcomes in children? A systematic review protocol

    PubMed Central

    2014-01-01

    Background Cardiovascular disease and type 2 diabetes are examples of chronic diseases that impose significant morbidity and mortality in the general population worldwide. Most chronic diseases are associated with underlying preventable risk factors, such as elevated blood pressure, high blood glucose or glucose intolerance, high lipid levels, physical inactivity, excessive sedentary behaviours, and overweight/obesity. The occurrence of intermediate outcomes during childhood increases the risk of disease in adulthood. Sugar-sweetened beverages are known to be significant sources of additional caloric intake, and given recent attention to their contribution in the development of chronic diseases, a systematic review is warranted. We will assess whether the consumption of sugar-sweetened beverages in children is associated with adverse health outcomes and what the potential moderating factors are. Methods/Design Of interest are studies addressing sugar-sweetened beverage consumption, taking a broad perspective. Both direct consumption studies as well as those evaluating interventions that influence consumption (e.g. school policy, educational) will be relevant. Non-specific or multi-faceted behavioural, educational, or policy interventions may also be included subject to the level of evidence that exists for the other interventions/exposures. Comparisons of interest and endpoints of interest are pre-specified. We will include randomized controlled trials, controlled clinical trials, interrupted time series studies, controlled before-after studies, prospective and retrospective comparative cohort studies, case–control studies, and nested case–control designs. The MEDLINE®, Embase, The Cochrane Library, CINAHL, ERIC, and PsycINFO® databases and grey literature sources will be searched. The processes for selecting studies, abstracting data, and resolving conflicts are described. We will assess risk of bias using design-specific tools. To determine sets of

  4. The Tobacco Pack Surveillance System: A Protocol for Assessing Health Warning Compliance, Design Features, and Appeals of Tobacco Packs Sold in Low- and Middle-Income Countries

    PubMed Central

    Washington, Carmen; Brown, Jennifer; Vadnais, Alison; Kroart, Laura; Ferguson, Jacqueline; Cohen, Joanna

    2015-01-01

    Background Tobacco remains the world’s leading preventable cause of death, with the majority of tobacco-caused deaths occurring in low- and middle-income countries. The first global health treaty, the Framework Convention on Tobacco Control (FCTC), outlines a set of policy initiatives that have been demonstrated as effective in reducing tobacco use. Article 11 of the FCTC focuses on using the tobacco package to communicate tobacco-caused harms; it also seeks to restrict the delivery of misleading information about the product on the pack. Objective The objective of this study was to establish a surveillance system for tobacco packs in the 14 low- and middle-income countries with the greatest number of smokers. The Tobacco Pack Surveillance System (TPackSS) monitors whether required health warnings on tobacco packages are being implemented as intended, and identifies pack designs and appeals that might violate or detract from the communication of harm-related information and undermine the impact of a country’s tobacco packaging laws. The protocol outlined is intended to be applicable or adaptable for surveillance efforts in other countries. Methods Tobacco packs were collected in 14 countries during 2013. The intention was, to the extent possible, to construct a census of “unique” pack presentations available for purchase in each country. The TPackSS team partnered with in-country field staff to implement a standardized protocol for acquiring packs from 36 diverse neighborhoods across three cities in each country. At the time of purchase, data on price and place of acquisition of each pack was recorded. The field staff, according to a standardized protocol, then photographed packs before they were shipped to the United States for coding and archiving. Results Each pack was coded for compliance with the country-specific health warning label laws, as well as for key design features of the pack and appeals of the branding elements. The coding protocols were

  5. Effectiveness of enteral feeding protocol on clinical outcomes in critically ill patients: a study protocol for before-and-after design

    PubMed Central

    Zhang, Zhongheng; Li, Qian; Jiang, Lingzhi; Xie, Bo; Ji, Xiaowei; Lu, Jiahong; Jiang, Ronglin; Lei, Shu; Mao, Shihao; Ying, Lijun; Lu, Di; Si, Xiaoshui; He, Jianxin; Ji, Mingxia; Zhu, Jianhua; Chen, Guodong; Shao, Yadi; Xu, Yinghe; Lin, Ronghai; Zhang, Chao; Zhang, Weiwen; Luo, Jian; Lou, Tianzheng; He, Xuwei; Chen, Kun

    2016-01-01

    Introduction Enteral feed is an important component of nutritional therapy in critically ill patients and underfeeding has been associated with adverse outcomes. The article developed an enteral feeding protocol and planed a before-and-after comparative trial to explore whether implementation of enteral feeding protocol was able to improve clinical outcomes. Methods and analysis The study will be conducted in intensive care units (ICUs) of ten tertiary care academic centers. Critically ill patients expected to stay in ICU for over 3 days and require enteral nutrition (EN) were potentially eligible. This is a before-and-after study comprising three phases: The first phase is the period without enteral feeding protocol; the second phase involves four-week training program, and the last phase is to perform the protocol in participating centers. We plan to enroll a total of 350 patients to provide an 80% power and 0.05 error rate to detect a 15% reduction of mortality. The primary outcome is 28-day mortality. Ethics and dissemination Ethical approval to conduct the research has been obtained from all participating centers. Additionally, the results will be published in peer-reviewed journal. Trial registration The study was registered at International Standard Registered Clinical/soCial sTudy Number (ISRCTN) registry (ISRCTN10583582). PMID:27668228

  6. Nigerian Population Research on Environment, Gene and Health (NIPREGH) – objectives and protocol

    PubMed Central

    Odili, Augustine N.; Ogedengbe, John O.; Nwegbu, Maxwell; Anumah, Felicia O.; Asala, Samuel; Staessen, Jan A

    2014-01-01

    Abstract Sub-Saharan Africa is currently undergoing an epidemiological transition from a disease burden largely attributable to communicable diseases to that resulting from a combination of both communicable and chronic non-communicable diseases. Data on chronic disease incidence, lifestyle, environmental and genetic risk factors are sparse in this region. This report aimed at providing relevant information in respect to risk factors that increase blood pressure and lead to development of intermediate cardiovascular phenotypes. We presented the rationale, objectives and key methodological features of the Nigerian Population Research on Environment, Gene and Health (NIPREGH) study. The challenges encountered in carrying out population study in this part of the world and the approaches at surmounting them were also presented. The preliminary data as at 20 November 2013 showed that out of the 205 individuals invited starting from early April 2013, 160 (72 women) consented and were enrolled; giving a response rate of 78%. Participants' age ranged from 18 to 80 years, with a mean (SD) of 39.8 (12.4) years and they were of 34 different ethnic groups spread over 24 states out of the 36 states that constitute Nigeria. The mean (SD) of office and home blood pressures were 113.0 (15.2) mm Hg systolic, 73.5 (12.5) mm Hg diastolic and 117.3 (15.0) mm Hg systolic, and 76.0 (9.6) mm Hg diastolic, respectively. Forty-three (26.8%) participants were hypertensive and 8 (5.0%) were diabetic. In addition to having the unique potential of recruiting a cohort that is a true representative of the entire Nigerian population, NIPREGH is feasible and the objectives realisable. PMID:25332707

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

    PubMed

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

    2016-09-01

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

  8. Protocol for study of financial incentives for smoking cessation in pregnancy (FISCP): randomised, multicentre study

    PubMed Central

    Berlin, Noémi; Goldzahl, Léontine; Jusot, Florence; Berlin, Ivan

    2016-01-01

    Introduction Maternal smoking during pregnancy is associated with adverse perinatal and postnatal health outcomes. The efficacy of nicotine replacement therapies in helping pregnant smokers to quit is not clearly demonstrated; therefore new interventions should be proposed and assessed. Financial incentives rewarding abstinence from tobacco smoking is one of the promising options. Objective To assess the efficacy of financial incentives on smoking abstinence among French pregnant smokers. Methods and analysis Participants: pregnant smokers aged ≥18 years, smoking at least five manufactured or three roll-your-own cigarettes per day, and pregnant for <18 weeks of amenorrhoea (WA). Setting: participants will be recruited, included and followed-up at monthly face-to-face visits in 16 maternity wards in France. Interventions: participants will be randomised to a control or an intervention group. After a predefined quit date, participants in the control group will receive €20 vouchers at the completion of each visit but no financial incentive for smoking abstinence. Participants in the intervention group will be rewarded for their abstinence by vouchers on top of the €20 show-up fee. The amount of reward for abstinence will increase as a function of duration of abstinence to stimulate longer periods of abstinence. Main outcome measure: complete abstinence from quit date to the last predelivery visit. Secondary outcome measures: point prevalence abstinence, time to relapse to smoking, birth weight, fetal growth restriction, preterm birth. Main data analysis: outcomes will be analysed on an intention-to-treat (ITT) basis. The ITT population is defined as all randomised smoking pregnant women. Ethics and dissemination The research protocol was approved by the ethics committee (Comité de Protection des Personnes, CPP) of the Pitié-Salpêtrière Hospital on 15 May 2015, and Amendment No 1 was approved on 13 July 2015. Results will be presented at scientific

  9. Monitoring activities of teenagers to comprehend their habits: study protocol for a mixed-methods cohort study

    PubMed Central

    2013-01-01

    Background Efforts to increase physical activity in youth need to consider which activities are most likely to be sustained over time in order to promote lifelong participation in physical activity. The Monitoring Activities of Teenagers to Comprehend their Habits (MATCH) study is a prospective cohort study that uses quantitative and qualitative methods to develop new knowledge on the sustainability of specific physical activities. Methods/design Eight hundred and forty-three grade 5 and 6 students recruited from 17 elementary schools in New Brunswick, Canada, are followed-up three times per year. At each survey cycle, participants complete self-report questionnaires in their classroom under the supervision of trained data collectors. A sub-sample of 24 physically active students is interviewed annually using a semi-structured interview protocol. Parents (or guardians) complete telephone administered questionnaires every two years, and a health and wellness school audit is completed for each school. Discussion MATCH will provide a description of the patterns of participation in specific physical activities in youth, and enable identification of the determinants of maintenance, decline, and uptake of participation in each activity. These data will inform the development of interventions that take into account which activities are the most likely to be maintained and why activities are maintained or dropped. PMID:23849265

  10. Study protocol: first nationwide comparative audit of acute lower gastrointestinal bleeding in the UK

    PubMed Central

    Oakland, Kathryn; Guy, Richard; Uberoi, Raman; Seeney, Frances; Collins, Gary; Grant-Casey, John; Mortensen, Neil; Murphy, Mike; Jairath, Vipul

    2016-01-01

    Introduction Acute lower gastrointestinal bleeding (LGIB) is a common indication for emergency hospitalisation worldwide. In contrast to upper GIB, patient characteristics, modes of investigation, transfusion, treatment and outcomes are poorly described. There are minimal clinical guidelines to inform care pathways and the use of endoscopy, including (diagnostic and therapeutic yields), interventional radiology and surgery are poorly defined. As a result, there is potential for wide variation in practice and clinical outcomes. Methods and analysis The UK Lower Gastrointestinal Bleeding Audit is a large nationwide audit of adult patients acutely admitted with LGIB or those who develop LGIB while hospitalised for another reason. Consecutive, unselected presentations with LGIB will be enrolled prospectively over a 2-month period at the end of 2015 and detailed data will be collected on patient characteristics, comorbidities, use of anticoagulants, transfusion, timing and modalities of diagnostic and therapeutic procedures, clinical outcome, length of stay and mortality. These will be audited against predefined minimum standards of care for LGIB. It is anticipated that over 80% of all acute hospitals in England and some hospitals in Scotland, Wales and Northern Ireland will participate. Data will be collected on the availability and organisation of care, provision of diagnostic and therapeutic GI endoscopy, interventional radiology, surgery and transfusion protocols. Ethics and dissemination This audit will be conducted as part of the national comparative audit programme of blood transfusion through collaboration with specialists in gastroenterology, surgery and interventional radiology. Individual reports will be provided to each participant site as well as an overall report and disseminated through specialist societies. Results will also be published in peer-reviewed journals. The study has been funded by National Health Services (NHS) Blood and Transplant and the

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

    NASA Astrophysics Data System (ADS)

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

    1998-08-01

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

  12. The Integrated Taxonomy of Health Care: Classifying Both Complementary and Biomedical Practices Using a Uniform Classification Protocol

    PubMed Central

    Porcino, Antony; MacDougall, Colleen

    2009-01-01

    Background: Since the late 1980s, several taxonomies have been developed to help map and describe the interrelationships of complementary and alternative medicine (CAM) modalities. In these taxonomies, several issues are often incompletely addressed: A simple categorization process that clearly isolates a modality to a single conceptual categoryClear delineation of verticality—that is, a differentiation of scale being observed from individually applied techniques, through modalities (therapies), to whole medical systemsRecognition of CAM as part of the general field of health care Methods: Development of the Integrated Taxonomy of Health Care (ITHC) involved three stages: Development of a precise, uniform health glossaryAnalysis of the extant taxonomiesUse of an iterative process of classifying modalities and medical systems into categories until a failure to singularly classify a modality occurred, requiring a return to the glossary and adjustment of the classifying protocol Results: A full vertical taxonomy was developed that includes and clearly differentiates between techniques, modalities, domains (clusters of similar modalities), systems of health care (coordinated care system involving multiple modalities), and integrative health care. Domains are the classical primary focus of taxonomies. The ITHC has eleven domains: chemical/substance-based work, device-based work, soft tissue–focused manipulation, skeletal manipulation, fitness/movement instruction, mind–body integration/classical somatics work, mental/emotional–based work, bio-energy work based on physical manipulation, bio-energy modulation, spiritual-based work, unique assessments. Modalities are assigned to the domains based on the primary mode of interaction with the client, according the literature of the practitioners. Conclusions: The ITHC has several strengths: little interpretation is used while successfully assigning modalities to single domains; the issue of taxonomic verticality is

  13. Detection of Outliers Due to Participants’ Non-Adherence to Protocol in a Longitudinal Study of Cognitive Decline

    PubMed Central

    Shipley, Martin J.; Welch, Catherine; Kivimaki, Mika; Singh-Manoux, Archana

    2015-01-01

    Background Participants’ non adherence to protocol affects data quality. In longitudinal studies, this leads to outliers that can be present at the level of the population or the individual. The purpose of the present study is to elaborate a method for detection of outliers in a study of cognitive ageing. Methods In the Whitehall II study, data on a cognitive test battery have been collected in 1997-99, 2002-04, 2007-09 and 2012-13. Outliers at the 2012-13 wave were identified using a 4-step procedure: (1) identify cognitive tests with potential non-adherence to protocol, (2) choose a prediction model between a simple model with socio-demographic covariates and one that also includes health behaviours and health measures, (3) define an outlier using a studentized residual, and (4) study the impact of exclusion of outliers by estimating the effect of age and diabetes on cognitive decline. Results 5516 participants provided cognitive data in 2012-13. Comparisons of rates of annual decline over the first three and all four waves of data suggested outliers in three of the 5 tests. Mean residuals for the 2012-13 wave were larger for the basic compared to the more complex prediction model (all p<0.001), leading us to use the latter for the identification of outliers. Residuals greater than two standard deviation of residuals identified approximately 7% of observations as being outliers. Removal of these observations from the analyses showed that both age and diabetes had associations with cognitive decline similar to that observed with the first three waves of data; these associations were weaker or absent in non-cleaned data. Conclusions Identification of outliers is important as they obscure the effects of known risk factor and introduce bias in the estimates of cognitive decline. We showed that an informed approach, using the range of data collected in a longitudinal study, may be able to identify outliers. PMID:26161552

  14. The Air Force health study: an epidemiologic retrospective.

    PubMed

    Buffler, Patricia A; Ginevan, Michael E; Mandel, Jack S; Watkins, Deborah K

    2011-09-01

    In 1979, the U.S. Air Force announced that an epidemiologic study would be undertaken to determine whether the Air Force personnel involved in Operation Ranch Hand-the program responsible for herbicide spraying in Vietnam-had experienced adverse health effects as a result of that service. In January 1982 the Air Force Health Study (AFHS) protocol was approved and the 20 year matched cohort study consisting of independent mortality, morbidity and reproductive health components was initiated. This controversial study has been criticized regarding the study's potential scientific limitations as well as some of the administrative aspects of its conduct. Now, almost 30 years since the implementation of the AFHS and nearly a decade since the final follow up examinations, an appraisal of the study indicates that the results of the AFHS do not provide evidence of disease in the Ranch Hand veterans caused by their elevated levels of exposure to Agent Orange. PMID:21441038

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

    PubMed Central

    2010-01-01

    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 Infant Simulator based programs

  16. Protocol: a realist review of user fee exemption policies for health services in Africa

    PubMed Central

    Ridde, Valéry; Marchal, Bruno; Fournier, Pierre

    2012-01-01

    ethics committee of the CHUM Research Centre (CR-CHUM). It received funding from the Canadian Institutes of Health Research. The funders will not have any role in study design; collection, management, analysis, and interpretation of data; writing of the report and the decision to submit the report for publication, including who will have ultimate authority over each of these activities. PMID:22275427

  17. eHealth Use Among First-Generation Immigrants From Pakistan in the Oslo Area, Norway, With Focus on Diabetes: Survey Protocol

    PubMed Central

    Kjøllesdal, Marte Karoline Råberg; Mirkovic, Jelena; Andreassen, Hege Kristin

    2016-01-01

    Background A variety of eHealth services are available and commonly used by the general public. eHealth has the potential to engage and empower people with managing their health. The prerequisite is, however, that eHealth services are adapted to the sociocultural heterogeneity of the user base and are available in a language and with contents that fit the users’ preference, skills, and abilities. Pakistani immigrants in the Oslo area, Norway, have a much higher risk of Type-2 diabetes (T2D) than their Norwegian counterparts do. In spite of having access to information and communication technology (ICT) and the Internet, ICT skills in this population are reported to be relatively low. Further, there is insufficient information about their use of and attitudes toward eHealth services, necessitating investigation of this group in particular. Objective This study targets first-generation immigrants from Pakistan living in the Oslo area and examines their use of and attitudes toward eHealth services, specifically: information searches, communication using ICT, and use of ICT for self-management or decision making, all concerning T2D. Methods Due to a high prevalence of low literacy among the target population, we employed questionnaire-based individual interviews. The questionnaire was developed by implementing potentially relevant theoretical constructs (technology acceptance model (TAM) and health belief model (HBM)) as measures. To explore issues around language, culture, and general ICT skills, we also implemented questions that we assume were particularly relevant in the context studied but do not appear in any theoretical frameworks. The questionnaire was revised to reflect results of a pilot study involving 10 participants. We employed culturally sensitive sampling methods to reach informants who could otherwise fail to be included in the survey. Results This paper presents a survey protocol. The data collection is ongoing. The aim is to collect 200 responses

  18. A Beginning Communication Intervention Protocol: In-Service Training of Health Workers

    ERIC Educational Resources Information Center

    Bornman, Juan; Alant, Erna; Lloyd, Lyle L.

    2007-01-01

    Primary health care nurses are frequently overlooked when delivering services to children with developmental disabilities, despite the fact that they are often the first contact many primary caregivers have with rehabilitation professionals and usually remain the bridge between caregivers and professionals. A time series one group design with…

  19. A "Triple Threat" to Research Protocols and Logistics: Adolescents, Sexual Health, and Poverty.

    PubMed

    Morrison-Beedy, Dianne; Passmore, Denise; Baker, Elizabeth

    2016-01-01

    The purpose of this article is to discuss lessons learned from conducting research with urban communities. A brief overview of the Health Improvement Project for Teens (HIPTeens) will be provided. It will be followed by several suggestions concerning recruitment and retention of participants, challenges related to working in impoverished environments, hiring and training of research teams, interacting with administration and community, and strategies for doing research in diverse settings.

  20. Driving Position Field Study, Differences with the Whiplash Protocol and Biomechanics Experimental Responses

    PubMed Central

    Arregui-Dalmases, Carlos; Pozo, Eduardo Del; Lessley, David; Barrios, Jose Manuel; Nombela, Mario; Cisneros, Oscar; de Miguel, Juan Luis; Seguí-Gómez, María

    2011-01-01

    Rear-impact collisions at low speed are a leading cause of economic costs among motor vehicle accidents. Recently, EuroNCAP has incorporated in its protocol the whiplash test, to reproduce a low-speed rear impact. This paper presents a field driving study to assess the potential differences between the EuroNCAP dummy tests and actual drivers in the field, focusing on occupant position and biomechanics experimental results. A total of 182 drivers were randomly selected in two geographical areas in Spain. The driving position of each driver was recorded with a focus on the most relevant measurements for rear impact. Statistical analysis was performed to obtain means, standard deviations and density functions to compare observational seating position with that of the EuroNCAP testing protocol. The observational data showed a similar seatback angle to that used in the EuroNCAP protocol (24° in front of 25° for the protocol), a greater distance between the head vertex and the top of the head restraint (53mm compared to 39.5mm), and less distance between the occipital bone of the head and the headrest (67.9 compared to 89.3mm). Based on these data, 4 dummy tests were conducted using the dummy BioRID IIg. The baseline test was designed to reproduce the dummy position according to EuroNCAP 3.0 whiplash protocol. Three different additional tests were defined to reproduce the actual observed driving position as well as to assess a “worst case” scenario in terms of reduced seatback angle. These variations in initial driver position, comparing the EuroNCAP protocol to the observational study results, were not observed to cause significant differences in the biomechanical values measured in the BioRID IIg, The T1 acceleration was reduced less than 8%, the NIC was increased about 8%, and the NKm presented a reduction of 20%. Reducing the seat angle was observed to be more harmful in terms of NIC. PMID:22105385

  1. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial

    PubMed Central

    2014-01-01

    analyzed. Discussion Our study results will contribute to feasibility evaluation and to relevant RCT protocol development for a full-scale RCT on combined treatment of BVA and NSAIDs for CNP patients. Trial registration This study is registered with the United States (US) National Institutes of Health Clinical Trials Registry: NCT01922466. PMID:24746224

  2. Characterizing Diversity of Lactobacilli Associated with Severe Early Childhood Caries: A Study Protocol

    PubMed Central

    Argimón, Silvia; Schön, Catherine N.; Saraithong, Prakaimuk; Caufield, Page W.

    2015-01-01

    Lactobacilli have been consistently associated with dental caries for decades; however, knowledge of this group of bacteria in the etiology of the disease is limited to quantitative elucidation. Nowadays, explicit identification of oral Lactobacillus species is possible, despite their taxonomic complexity. Here we describe a combined approach involving both cultivation and genetic methods to ascertain and characterize the diversity and abundance of the Lactobacillus population in the oral cavities of children with severe early childhood caries (S-ECC). Eighty 3- to 6-year-old children (40 S-ECC and 40 caries free) who were seeking dental care at the Pediatric Dental Clinic of Bellevue Hospital in New York City were invited to participate in this study. Clinical data on socio-demographic information and oral health behavior were obtained from the primary caregiver. The data included a detailed dental examination, children’s medical history, and a questionnaire survey. Combined non-stimulated saliva and supra-gingival plaque samples were collected from each child and cultivated on selective media for quantitative measures of lactobacilli levels. The procedure for Lactobacillus species screening will include the random selection of 50 colonies per plate, extraction of DNA from each colony, and genotyping by arbitrarily primed polymerase chain reaction (AP-PCR). Each unique Lactobacillus AP-PCR genotype will be selected for taxonomic assessment by 16S rRNA gene sequencing analysis. Lactobacillus species will be identified by comparing the 16S rRNA sequences with the Ribosomal Database and the Human Oral Microbiome Database. Meanwhile, the same set of clinical samples will be independently subjected to genomic DNA isolation, 16S rRNA amplification with Lactobacillus genus-specific primers, sequencing, and taxonomic identification, both at genus and species levels with a customized pipeline. The distribution and phylogenetic differences of these Lactobacillus species

  3. The Effect of Absenteeism and Clinic Protocol on Health Outcomes: The Case of Mother-to-Child Transmission of HIV in Kenya

    PubMed Central

    Goldstein, Markus; Zivin, Joshua Graff; Habyarimana, James; Pop-Eleches, Cristian; Thirumurthy, Harsha

    2012-01-01

    Absenteeism of health workers in developing countries is widespread with some estimates indicating rates of provider absence of nearly 40% (Chaudhury et. al. 2006). This is the first paper to present evidence of the impact of health provider absence combined with limitations in health clinic protocol on health outcomes. Using longitudinal data from nearly 600 ante-natal care seekers at a rural ante-natal clinic in Western Kenya, we find that nurse absence on a patient’s first visit significantly reduces the probability that a woman tests for HIV over her entire pregnancy. Since the benefits of PMTCT services depend on HIV status, we proxy HIV status with self-reported pre-test expectations of being HIV-positive and estimate the heterogeneous impact of absence based on these self-reported expectations. We find that women with a high pre-test expectation of testing HIV-positive and whose first ANC visit coincides with nurse attendance are 25 percentage points more likely to deliver in a hospital or health center, 7.4 percentage points more likely to receive PMTCT medication, 9 percentage points less likely to breastfeed and 10 percentage points more likely to enroll in the free AIDS treatment program at the clinic than similar women whose first visit coincides with nurse absence. The procedural shortcomings in our study setting, shortcomings that do not enable pregnant women to test on a subsequent clinic visit, appear common in other countries in sub-Saharan Africa. They suggest that nurse absence in the context of this medical system translates into sizable reductions in child and maternal health. PMID:24163722

  4. Development of the Draft Clinical Guideline on How to Resuscitate Dying Patients in the Iranian Context: A Study Protocol

    PubMed Central

    Cheraghi, Mohammad Ali; Bahramnezhad, Fatemeh; Mehrdad, Neda; Zendehdel, Kazem

    2016-01-01

    Introduction: The guidelines can be used as a model to guide the implementation of the best options and a suitable framework for clinical decisions. Even a guideline can largely help in challenging problems such as not to resuscitate with high cultural and value load. The guidelines try to improve the health care quality through reducing the treatment costs and variety of care measures. This study aimed to prepare a draft of clinical guidelines with the main aim of designing and drafting the clinical guideline on resuscitation in dying patients. Methodology: After selecting the subject of this guideline, in the first meeting of the team members of drafting the guideline, the guideline scope was determined. Then, the literature review done without time limitation, through searching electronic bibliographic information and internet databases and sites such as Medline, EMBASE, Springer, Blackwell Synergy, Elsevier, Scopus, Cochran Library and also databases including SID, Iran Medex, and Magiran. The experts will be the interviewed, and the interviews are directed content analysis. Conclusion: Finally, recommendations will be formed by nominal group technique. This study protocol includes informative information for designing and conducting of health professionals intending to create a direct on qualitative, theoretical, philosophical, spiritual, and moral health aspects. PMID:27559265

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

    PubMed Central

    2010-01-01

    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 treatment approaches in terms of

  6. Requirements and Design of the PROSPER Protocol for Implementation of Information Infrastructures Supporting Pandemic Response: A Nominal Group Study

    PubMed Central

    Timpka, Toomas; Eriksson, Henrik; Gursky, Elin A.; Strömgren, Magnus; Holm, Einar; Ekberg, Joakim; Eriksson, Olle; Grimvall, Anders; Valter, Lars; Nyce, James M.

    2011-01-01

    Background Advanced technical systems and analytic methods promise to provide policy makers with information to help them recognize the consequences of alternative courses of action during pandemics. Evaluations still show that response programs are insufficiently supported by information systems. This paper sets out to derive a protocol for implementation of integrated information infrastructures supporting regional and local pandemic response programs at the stage(s) when the outbreak no longer can be contained at its source. Methods Nominal group methods for reaching consensus on complex problems were used to transform requirements data obtained from international experts into an implementation protocol. The analysis was performed in a cyclical process in which the experts first individually provided input to working documents and then discussed them in conferences calls. Argument-based representation in design patterns was used to define the protocol at technical, system, and pandemic evidence levels. Results The Protocol for a Standardized information infrastructure for Pandemic and Emerging infectious disease Response (PROSPER) outlines the implementation of information infrastructure aligned with pandemic response programs. The protocol covers analyses of the community at risk, the response processes, and response impacts. For each of these, the protocol outlines the implementation of a supporting information infrastructure in hierarchical patterns ranging from technical components and system functions to pandemic evidence production. Conclusions The PROSPER protocol provides guidelines for implementation of an information infrastructure for pandemic response programs both in settings where sophisticated health information systems already are used and in developing communities where there is limited access to financial and technical resources. The protocol is based on a generic health service model and its functions are adjusted for community-level analyses

  7. A SERLINE-based union list of serials for basic health sciences libraries: a detailed protocol.

    PubMed Central

    Bell, C L

    1982-01-01

    In March 1981 the Consortium for Information Resources (CIR) was chosen by the Massachusetts Health Sciences Library Network to develop and automate a statewide biomedical union list of serials. Employing a commercial processor, ANSI standard Z39.42-1980, and SERLINE, CIR consolidated the journal holdings of six Massachusetts health-related library consortia. SERLINE, with its unique identifier as the single control element, governed the form of entry and bibliographic data for each journal. Additionally, SERLINE enhanced the union list by providing "see references" and general notations to map users to main titles or special information. An original feature of this union list is the "rolled" holdings and location statements intended to encourage even distribution of interlibrary loan transactions. The resulting union list of serials includes the holdings of 116 Massachusetts libraries, 94 of which are hospital libraries. The list includes nearly 3,000 unique titles and 15,000 holdings statements; production costs averaged $1.35 per unique title and 27 per holdings statement. PMID:6758891

  8. Evaluating the transport, health and economic impacts of new urban cycling infrastructure in Sydney, Australia – protocol paper

    PubMed Central

    2013-01-01

    Background There are repeated calls to build better cycling paths in Australian cities if the proportion of people cycling is to increase. Yet the full range of transport, health, environmental and economic impacts of new cycling infrastructure and the extent to which observed changes are sustained is not well understood. The City of Sydney is currently building a new bicycle network, which includes a new bicycle path separated from road traffic in the south Sydney area. This protocol paper describes a comprehensive method to evaluate this new cycling infrastructure. Method A cohort of residents within two kilometres of the new bicycle path will be surveyed at baseline before a new section of bicycle path is built, and again 12 and 24 months later to assess changes in travel behaviour, sense of community, quality of life and health behaviours. Residents in a comparable area of Sydney that will not get a new separated bike path will act as a comparison group. At baseline a sub-set of residents who volunteer will also take a small GPS device with them for one week to assess travel behaviour. Discussion This research should contribute to the advancement in evaluation and appraisal methods for cycling projects. PMID:24131667

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

    SciTech Connect

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

    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)

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

    PubMed Central

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

    2012-01-01

    Summary Introduction: The merging of medicine with information technology facilitates the retrieval of stored data, aiding the conduct of research with greater scientific rigor. Studies in the field of otorhinolaryngology, specifically in the area of laryngology and voice, are of fundamental importance, since 70% of the economically active need their voice to work. Objective: To create a computerized protocol of the diseases of the larynx, apply and validate it, and use it to evaluate patients undergoing laryngoscopic microsurgery of the larynx. Method: We created a database of ENT diseases through a literature review of textbooks and scientific articles. Next, we computerized the data and incorporated it into the SINPE©, creating a master protocol (ENT diseases) and a specific protocol (laryngeal diseases). Data were collected prospectively from patients undergoing laryngeal microsurgery in the ENT Hospital of Paraná. The collected data were analyzed with graphs through the SINPE© Analyzer module. Results: We evaluated 245 patients aged 9–79 years, and determined that 36.61% (93 patients) underwent surgery for the presence of polyps on the vocal folds, 12.6% (32) underwent surgery for papillomatosis, and 11.83% (29) underwent surgery for intracordal cysts. Conclusions: The creation of an electronic database of clinical ENT diseases was feasible. We were also able to implement and validate the protocol. The database may be released to physicians involved in clinical data collection and retrieval of information to conduct scientific research in an organized manner. The most common laryngeal disorders identified were polyps, papilloma, and intracordal cysts. PMID:25991956

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

    PubMed Central

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

    2015-01-01

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

  12. Use of clomiphene-based stimulation protocol in oocyte donors: A comparative study

    PubMed Central

    Singh, Aparna; Bhandari, Shilpa; Agrawal, Pallavi; Gupta, Nitika; Munaganuru, Niharika

    2016-01-01

    INTRODUCTION: This study was undertaken to compare between clomiphene citrate (CC) and gonadotropin-releasing hormone antagonist-based protocols in donor-recipient cycles in terms of parameters of ovarian stimulation and obstetric outcome. MATERIALS AND METHODS: Two hundred and three fertile oocyte donors were stimulated using two different protocols: Clomiphene based (n = 103) and antagonist based (n = 100). Donors in the one group were stimulated from day 1 or 2 of spontaneous or withdrawal bleeds with CC (50 mg/day) and recombinant follicle-stimulating hormone (FSH) till the day of trigger while donors in the other group were stimulated using recombinant FSH from day 1 or 2, and the antagonist was added as per flexible antagonist protocol. When >3 follicles were >17 mm in diameter, trigger was given with 2 mg leuprolide intramuscular. Transvaginal oocyte retrieval was done after 34 h of trigger. RESULTS: There was no significant difference in between the two groups in terms of age, antral follicle count, starting dose of gonadotropins, total dose required, duration of stimulation, number of follicles retrieved, mature follicles, and fertilization rate. The serum estradiol levels were significantly raised in the clomiphene group (P < 0.001). Pregnancy rate was similar in both the groups. The clinical pregnancy rate was 65.94% in the clomiphene group and 57.46% in the antagonist group. The live birth rate per cycle started was 47.8% in the clomiphene group and 39.55% in the antagonist group. There was one case of ectopic pregnancy in the antagonist group. CONCLUSION: Controlled ovarian stimulation using clomiphene and gonadotropin is a viable option for donor oocyte cycles. The cost and number of injections used per cycle can be reduced by using the clomiphene-based protocols. PMID:27803583

  13. Examining the social determinants of children's developmental health: protocol for building a pan-Canadian population-based monitoring system for early childhood development

    PubMed Central

    Guhn, Martin; Janus, Magdalena; Enns, Jennifer; Brownell, Marni; Forer, Barry; Duku, Eric; Muhajarine, Nazeem; Raos, Rob

    2016-01-01

    Introduction Early childhood is a key period to establish policies and practices that optimise children's health and development, but Canada lacks nationally representative data on social indicators of children's well-being. To address this gap, the Early Development Instrument (EDI), a teacher-administered questionnaire completed for kindergarten-age children, has been implemented across most Canadian provinces over the past 10 years. The purpose of this protocol is to describe the Canadian Neighbourhoods and Early Child Development (CanNECD) Study, the aims of which are to create a pan-Canadian EDI database to monitor trends over time in children's developmental health and to advance research examining the social determinants of health. Methods and analysis Canada-wide EDI records from 2004 to 2014 (representing over 700 000 children) will be linked to Canada Census and Income Taxfiler data. Variables of socioeconomic status derived from these databases will be used to predict neighbourhood-level EDI vulnerability rates by conducting a series of regression analyses and latent variable models at provincial/territorial and national levels. Where data are available, we will measure the neighbourhood-level change in developmental vulnerability rates over time and model the socioeconomic factors associated with those trends. Ethics and dissemination Ethics approval for this study was granted by the Behavioural Research Ethics Board at the University of British Columbia. Study findings will be disseminated to key partners, including provincial and federal ministries, schools and school districts, collaborative community groups and the early childhood development research community. The database created as part of this longitudinal population-level monitoring system will allow researchers to associate practices, programmes and policies at school and community levels with trends in developmental health outcomes. The CanNECD Study will guide future early childhood

  14. The association between proximity to animal-feeding operations and community health: a protocol for updating a systematic review

    PubMed Central

    2014-01-01

    Background Livestock and poultry operations that feed large numbers of animals are common. Facility capacity varies, but it is not uncommon for facilities to house 1,000 swine with multiple barns at a single site, feedlots to house 50,000 cattle, and poultry houses to house 250,000 hens. There is primary research that suggests livestock facilities that confine animals indoors for feeding can represent a health hazard for surrounding communities. In this protocol, we describe a review about the association between proximity to animal-feeding operations (AFOs) and the health of individuals in nearby communities. A systematic review of the topic was published by some members of our group in 2010. The purpose of this review is to update that review. Methods/Design The populations of interest are people living in communities near livestock production facilities. Outcomes of interest are any health outcome measured in humans such as respiratory disease, gastrointestinal disease, and mental health. Measures of antibiotic resistance in people from the communities compared to measures of resistance found in animals and the environment on animal-feeding operations will also be summarized. The exposure of interest will be exposure to livestock production using a variety of metrics such as distance from facilities, endotoxin levels, and measures of odor. Electronic searches will be conducted using MEDLINE and MEDLINE In-Process (via OvidSP), CAB Abstracts (via Web of Knowledge), and Science Citation Index (via Web of Knowledge). No language or date restriction will be applied. We will access the risk of bias using a pilot version of a tool developed by the Methods Groups of the Cochrane Collaboration for non-randomized interventions. We propose to conduct a meta-analysis for each health metric (e.g., combining all respiratory disease outcomes, combining all gastrointestinal outcomes). A planned subgroup analysis will be based on the domains of the risk of bias. Discussion This

  15. The stages of implementation completion for evidence-based practice: protocol for a mixed methods study

    PubMed Central

    2014-01-01

    Background This protocol describes the ‘development of outcome measures and suitable methodologies for dissemination and implementation approaches,’ a priority for implementation research. Although many evidence-based practices (EBPs) have been developed, large knowledge gaps remain regarding how to routinely move EBPs into usual care. The lack of understanding of ‘what it takes’ to install EBPs has costly public health consequences, including a lack of availability of the most beneficial services, wasted efforts and resources on failed implementation attempts, and the potential for engendering reluctance to try implementing new EBPs after failed attempts. The Stages of Implementation Completion (SIC) is an eight-stage tool of implementation process and milestones, with stages spanning three implementation phases (pre-implementation, implementation, sustainability). Items delineate the date that a site completes implementation activities, yielding an assessment of duration (time to complete a stage), proportion (of stage activities completed), and a general measure of how far a site moved in the implementation process. Methods/Design We propose to extend the SIC to EBPs operating in child service sectors (juvenile justice, schools, substance use, child welfare). Both successful and failed implementation attempts will be scrutinized using a mixed methods design. Stage costs will be measured and examined. Both retrospective data (from previous site implementation efforts) and prospective data (from newly adopting sites) will be analyzed. The influence of pre-implementation on implementation and sustainability outcomes will be examined (Aim 1). Mixed methods procedures will focus on increasing understanding of the process of implementation failure in an effort to determine if the SIC can provide early detection of sites that are unlikely to succeed (Aim 2). Study activities will include cost mapping of SIC stages and an examination of the relationship between

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

    NASA Astrophysics Data System (ADS)

    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

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

    NASA Astrophysics Data System (ADS)

    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

  18. Pilot Testing a Cognitive-Behavioral Protocol on Psychosocial Predictors of Exercise, Nutrition, Weight, and Body Satisfaction Changes in a College-Level Health-Related Fitness Course

    ERIC Educational Resources Information Center

    Annesi, James J.; Howton, Amy; Johnson, Ping H.; Porter, Kandice J.

    2015-01-01

    Objective: Small-scale pilot testing of supplementing a required college health-related fitness course with a cognitive-behavioral exercise-support protocol (The Coach Approach). Participants: Three classes were randomly assigned to Usual processes (n = 32), Coach Approach-supplemented: Mid-size Groups (n = 32), and Coach Approach-supplemented:…

  19. Development of structural MR brain imaging protocols to study genetics and maturation

    PubMed Central

    Kochunov, Peter; Davis, M. Duff

    2009-01-01

    Structural imaging research offers excellent translational benefits when non-human primate (NHP) models are employed. In this paper, we will discuss the development of anatomical MR imaging protocols for two important applications of structural imaging in NHP: studies of genetic variability in brain morphology and longitudinal imaging of fetal brain maturation trends. In contrast with imaging studies of adult humans, structural imaging in the NHP is challenging due to a comparatively small brain size (2-200 fold smaller volume, depending on the species). This difference in size is further accentuated in NHP studies of brain development, in which fetal brain volumes are 10-50% of their adult size. The sizes of cortical gyri and sulci scale allometrically with brain size. Thus, achieving spatial sampling that is comparable to that of high-quality human studies (∼1.0 mm3) requires a brain-size-adjusted reduction in the sampling volumes of from 500-to-150 microns3. Imaging at this spatial resolution while maintaining sufficient contrast and signal to noise ratio necessitates the development of specialized MRI protocols. Here we discuss our strategy to optimize the protocol parameters for two commonly available structural imaging sequences: MPRAGE and TrueFisp. In addition, computational tools developed for the analysis of human structural images were applied to the NHP studies. These included removal of non-brain tissues, correction for RF inhomogeneity, spatial normalization, building of optimized target brain and analysis of cerebral gyrification and individual cortical variability. Finally, recent findings in the genetics of cerebral gyrification and tracking of maturation trends in the fetal, newborn and adult brain are described PMID:19665566

  20. Study protocol: Imaging brain development in the Childhood to Adolescence Transition Study (iCATS)

    PubMed Central

    2014-01-01

    Background 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). Methods/Design 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. Discussion 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. PMID:24779869

  1. Protocol for a systematic review of telephone delivered psychosocial interventions on relapse prevention, adherence to psychiatric medication and health risk behaviours in adults with a psychotic disorder

    PubMed Central

    Beck, Alison K; Baker, Amanda; Turner, Alyna; Haddock, Gillian; Kelly, Peter J; Berry, Katherine; Bucci, Sandra

    2015-01-01

    Introduction The mental and physical health of individuals with a psychotic illness are typically poor. When adhered to, medication can reduce relapse. However, despite adherence, relapse remains common and functional outcomes often remain compromised. Compliance is also typically low. Cardiovascular-related morbidity and mortality is also elevated, along with several important modifiable health risk behaviours. Access to psychosocial interventions is therefore important, but currently limited. Telephone delivered interventions represent a promising solution, although further clarity is needed. Accordingly, we aim to provide an overview and critical analysis of the current state of evidence for telephone delivered psychosocial interventions targeting key health priorities in adults with a psychotic disorder, including (1) relapse, (2) adherence to psychiatric medication and/or (3) modifiable cardiovascular health risk behaviours. Methods and analysis Our methods are informed by published guidelines. The review is registered and any protocol amendments will be tracked. Ten electronic peer-reviewed and four grey literature databases have been identified. Preliminary searches have been conducted for literature on psychosocial telephone interventions targeting relapse, medication adherence and/or health risk behaviours in adults with a psychotic disorder. Articles classified as ‘evaluation’ will be assessed against standardised criteria and checked by an independent assessor. The searches will be re-run just before final analyses and further studies retrieved for inclusion. A narrative synthesis will be reported, structured around intervention type and content, population characteristics and outcomes. Where possible, ‘summary of findings’ tables will be generated for each comparison. For the primary outcome of each trial, when data are available, we will calculate a risk ratio and its 95% CI (dichotomous outcomes) and/or effect size according to Cohen's formula

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

    PubMed Central

    2011-01-01

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

  3. A comparative study of routing protocols of heterogeneous wireless sensor networks.

    PubMed

    Han, Guangjie; Jiang, Xu; Qian, Aihua; Rodrigues, Joel J P C; Cheng, Long

    2014-01-01

    Recently, heterogeneous wireless sensor network (HWSN) routing protocols have drawn more and more attention. Various HWSN routing protocols have been proposed to improve the performance of HWSNs. Among these protocols, hierarchical HWSN routing protocols can improve the performance of the network significantly. In this paper, we will evaluate three hierarchical HWSN protocols proposed recently--EDFCM, MCR, and EEPCA--together with two previous classical routing protocols--LEACH and SEP. We mainly focus on the round of the first node dies (also called the stable period) and the number of packets sent to sink, which is an important aspect to evaluate the monitoring ability of a protocol. We conduct a lot of experiments and simulations on Matlab to analyze the performance of the five routing protocols. PMID:25050393

  4. Yoga for Health Care in Korea: A Protocol for Systematic Review of Clinical Trials.

    PubMed

    Choi, Jiae; Jun, Ji Hee; Lee, Ju Ah; Lee, Myeong Soo

    2016-08-01

    This systematic review aims to evaluate the therapeutic effects of yoga therapy using an evidence-based approach and investigates the relationship between yoga and the meridian energies based on all available clinical studies in Korea. Sixteen electronic databases will be searched from the inception of the study until January 2016. All clinical evidences that evaluate any type of yoga and any type of control in individuals with any type of condition will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool for randomized clinical trials and the Newcastle-Ottawa scale for nonrandomized studies. Two authors will independently assess each study for eligibility and the risk of bias, and then they will extract the data. With its extensive, unbiased search of the Korean literature from various databases without any language restrictions, this systematic review will be useful for both practitioners in the field of yoga research as well as for patients. PMID:27555227

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

    PubMed Central

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

    2016-01-01

    Introduction Paediatric respiratory tract infections (RTIs) are common reasons for primary care consultations and antibiotic prescribing. Locally relevant syndromic and microbiological surveillance information has the potential to improve the care of children with RTIs by normalising illness (parents) and reducing uncertainty (clinicians). Currently, most RTI studies are conducted at the point of healthcare service consultation, leaving the community burden, microbiology, symptom duration and proportion consulting largely unknown. This study seeks to establish the feasibility of (mainly online) participant recruitment and retention, and the acceptability/comparability of parent versus nurse-collected microbiological sampling, to inform the design of a future surveillance intervention study. Evidence regarding consultation rates and symptom duration is also sought. Methods and analysis A community-based, feasibility prospective inception cohort study, recruiting children aged ≥3 months and <16 years and their parents via general practitioner surgery invitation letter, aiming to collect data on 300 incident RTIs by July 2016. Following informed consent, parents provide baseline (demographic) data online, and respond to weekly emails to confirm the absence/presence of new RTI symptoms. Once symptomatic, parents provide daily data online (RTI symptoms, school/day-care attendance, time off work, health service use, medication), and a research nurse visits to collect clinical examination data and microbiological (nasal and saliva) swabs. Parents are invited to provide symptomatic (at nurse visit, but without nurse assistance) and asymptomatic (alone) swabs on recovery. A review of primary care medical notes will gather medical history, health service utilisation, referral and antibiotic prescribing rates. Feasibility will be assessed using recruitment and retention rates, data completeness; and acceptability by quantitative survey and qualitative interviews

  6. An e-Health Decision Support System for Improving Compliance of Health Workers to the Maternity Care Protocols in South Africa

    PubMed Central

    Horner, V.; Rautenbach, P.; Mbananga, N.; Mashamba, T.; Kwinda, H.

    2013-01-01

    Background There are problems of quality in maternity services at primary health care level in South Africa. Many of these problems can be traced to non-adherence to the maternity care guidelines and lack of tools to support clinic staff and managers in their roles. Objective: The aim of this research was to investigate the utility of e-health (computerized) decision support systems at addressing the problem of compliance of health workers to the maternity care guidelines at primary health care in South Africa. At present there are no documented studies on e-health clinical decision support systems for primary health care in South Africa, though clinical decision support systems for primary health care are listed as part of the e-health strategy of the National Department of Health. Methods: An e-health decision support system named the Bacis (Basic Antenatal Care Information System) Program was developed, then implemented and evaluated at a primary health care clinic. The duration of the study was two years: this includes development, implementation and evaluation. Results and Conclusion There was an overall improvement in compliance from 85.1 % to 89.3%. This result was not statistically significant. However when results were stratified into specific categories, the Bacis Program showed statistically significant improvement in compliance over the checklist system in three out of nine important categories. These are compliance at booking, patients younger than 18 years and patients booking after week 20. Further, insights and experience were also gained on development and implementation of clinical information systems at resource strained environments such as primary health care in South Africa. These results, insights and experience are invaluable for the implementation of the proposed e-health strategy in South Africa. PMID:23650485

  7. Access to Transplantation and Transplant Outcome Measures (ATTOM): study protocol of a UK wide, in-depth, prospective cohort analysis

    PubMed Central

    Oniscu, Gabriel C; Ravanan, Rommel; Wu, Diana; Gibbons, Andrea; Li, Bernadette; Tomson, Charles; Forsythe, John L; Bradley, Clare; Cairns, John; Dudley, Christopher; Watson, Christopher J E; Bolton, Eleanor M; Draper, Heather; Robb, Matthew; Bradbury, Lisa; Pruthi, Rishi; Metcalfe, Wendy; Fogarty, Damian; Roderick, Paul; Bradley, J Andrew

    2016-01-01

    Introduction There is significant intercentre variability in access to renal transplantation in the UK due to poorly understood factors. The overarching aims of this study are to improve equity of access to kidney and kidney–pancreas transplantation across the UK and to optimise organ allocation to maximise the benefit and cost-effectiveness of transplantation. Methods and analysis 6844 patients aged 18–75 years starting dialysis and/or receiving a transplant together with matched patients active on the transplant list from all 72 UK renal units were recruited between November 2011 and March 2013 and will be followed for at least 3 years. The outcomes of interest include patient survival, access to the transplant list, receipt of a transplant, patient-reported outcome measures (PROMs) including quality of life, treatment satisfaction, well-being and health status on different forms of renal replacement therapy. Sociodemographic and clinical data were prospectively collected from case notes and from interviews with patients and local clinical teams. Qualitative process exploration with clinical staff will help identify unit-specific factors that influence access to renal transplantation. A health economic analysis will explore costs and outcomes associated with alternative approaches to organ allocation. The study will deliver: (1) an understanding of patient and unit-specific factors influencing access to renal transplantation in the UK, informing potential changes to practices and policies to optimise outcomes and reduce intercentre variability; (2) a patient-survival probability model to standardise access to the renal transplant list and (3) an understanding of PROMs and health economic impact of kidney and kidney–pancreas transplantation to inform the development of a more sophisticated and fairer organ allocation algorithm. Ethics and dissemination The protocol has been independently peer reviewed by National Institute for Health Research (NIHR) and

  8. Iatrogenic newborn weight loss: knowledge translation using a study protocol for your maternity setting

    PubMed Central

    2011-01-01

    Background In our original study of newborn weight loss, we determined there were positive correlations among newborn weight loss, neonatal output, and the IV fluids mothers received before their babies' birth. Basically, an increase in maternal IV fluids is correlated to an increase in neonatal output and newborn weight loss. When assessing newborn weight change, our recommendation is to change baseline from birth weight to a weight measured at 24 hours. The purpose of this paper is to provide a protocol for clinicians to collect and analyze data from their own maternity site to determine if the newborns experience such an iatrogenic weight loss and to make decisions about how to assess newborn weight changes. Methods We recommend a prospective observational study with data collected about maternal fluids, neonatal output, and newborn weight measurements. The methods we suggest include specifics about recruitment, data collection, and data analysis. Discussion Quality assurance and research ethics considerations are described. We also share practical information that we learned from our original study. Ultimately, to encourage knowledge translation and research uptake, we provide a protocol and sound advice to do a research study in your maternity setting. PMID:21843331

  9. Assessment of equity in healthcare financing in Fiji and Timor-Leste: a study protocol

    PubMed Central

    Asante, Augustine D; Price, Jennifer; Hayen, Andrew; Irava, Wayne; Martins, Joao; Guinness, Lorna; Ataguba, John E; Limwattananon, Supon; Mills, Anne; Jan, Stephen; Wiseman, Virginia

    2014-01-01

    Introduction Equitable health financing remains a key health policy objective worldwide. In low and middle-income countries (LMICs), there is evidence that many people are unable to access the health services they need due to financial and other barriers. There are growing calls for fairer health financing systems that will protect people from catastrophic and impoverishing health payments in times of illness. This study aims to assess equity in healthcare financing in Fiji and Timor-Leste in order to support government efforts to improve access to healthcare and move towards universal health coverage in the two countries. Methods and analysis The study employs two standard measures of equity in health financing increasingly being applied in LMICs—benefit incidence analysis (BIA) and financing incidence analysis (FIA). In Fiji, we will use a combination of secondary and primary data including a Household Income and Expenditure Survey, National Health Accounts, and data from a cross-sectional household survey on healthcare utilisation. In Timor-Leste, the World Bank recently completed a health equity and financial protection analysis that incorporates BIA and FIA, and found that the distribution of benefits from healthcare financing is pro-rich. Building on this work, we will explore the factors that influence the pro-rich distribution. Ethics and dissemination The study is approved by the Human Research Ethics Committee of University of New South Wales, Australia (Approval number: HC13269); the Fiji National Health Research Committee (Approval # 201371); and the Timor-Leste Ministry of Health (Ref MS/UNSW/VI/218). Results Study outcomes will be disseminated through stakeholder meetings, targeted multidisciplinary seminars, peer-reviewed journal publications, policy briefs and the use of other web-based technologies including social media. A user-friendly toolkit on how to analyse healthcare financing equity will be developed for use by policymakers and

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

    SciTech Connect

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

    2009-06-01

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

  11. Nutritional route in oesophageal resection trial II (NUTRIENT II): study protocol for a multicentre open-label randomised controlled trial

    PubMed Central

    Berkelmans, Gijs H K; Wilts, Bas J W; Kouwenhoven, Ewout A; Kumagai, Koshi; Nilsson, Magnus; Weijs, Teus J; Nieuwenhuijzen, Grard A P; van Det, Marc J; Luyer, Misha D P

    2016-01-01

    Introduction Early start of an oral diet is safe and beneficial in most types of gastrointestinal surgery and is a crucial part of fast track or enhanced recovery protocols. However, the feasibility and safety of oral intake directly following oesophagectomy remain unclear. The aim of this study is to investigate the effects of early versus delayed start of oral intake on postoperative recovery following oesophagectomy. Methods and analysis This is an open-label multicentre randomised controlled trial. Patients undergoing elective minimally invasive or hybrid oesophagectomy for cancer are eligible. Further inclusion criteria are intrathoracic anastomosis, written informed consent and age 18 years or older. Inability for oral intake, inability to place a feeding jejunostomy, inability to provide written consent, swallowing disorder, achalasia, Karnofsky Performance Status <80 and malnutrition are exclusion criteria. Patients will be randomised using online randomisation software. The intervention group (direct oral feeding) will receive a liquid oral diet for 2 weeks with gradually expanding daily maximums. The control group (delayed oral feeding) will receive enteral feeding via a jejunostomy during 5 days and then start the same liquid oral diet. The primary outcome measure is functional recovery. Secondary outcome measures are 30-day surgical complications; nutritional status; need for artificial nutrition; need for additional interventions; health-related quality of life. We aim to recruit 148 patients. Statistical analysis will be performed according to an intention to treat principle. Results are presented as risk ratios with corresponding 95% CIs. A two-tailed p<0.05 is considered statistically significant. Ethics and dissemination Our study protocol has received ethical approval from the Medical research Ethics Committees United (MEC-U). This study is conducted according to the principles of Good Clinical Practice. Verbal and written informed consent is

  12. [Economic evaluation studies in health].

    PubMed

    Rovira-Forns, Joan; Antoñanzas-Villar, Fernando

    2005-12-01

    Clinical journals often publish economic evaluation studies of health technologies and programs. To improve the peer review process and, hence, the quality and validity of published studies, the British Medical Journal (BMJ) established publication guidelines for the publication of economic evaluations aimed at authors, reviewers and editors. The present article analyzes the opportunity of adopting the BMJ's or similar guidelines by Medicina Clínica and the probable effectiveness of this measure. The article concludes that although this initiative would probably improve the review process and the quality of the papers published, it might be worthwhile to review, up-date and adapt the BMJ guidelines to the Spanish context by means of a consensus-forming process. Finally, this article discusses the limitations of the peer review process in improving the quality and validity of economic evaluations and suggests some complementary measures, drawing on lessons and experiences from the field of clinical research.

  13. Calibration and data collection protocols for reliable lattice parameter values in electron pair distribution function (ePDF) studies

    DOE PAGESBeta

    Abeykoon, A. M. Milinda; Hu, Hefei; Wu, Lijun; Zhu, Yimei; Billinge, Simon J. L.

    2015-02-01

    We explore and describe different protocols for calibrating electron pair distribution function (ePDF) measurements for quantitative studies on nano-materials. We find the most accurate approach to determine the camera-length is to use a standard calibration sample of Au nanoparticles from National Institute of Standards and Technology. Different protocols for data collection are also explored, as are possible operational errors, to find the best approaches for accurate data collection for quantitative ePDF studies.

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

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

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

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

    PubMed

    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.

  16. A study of admissions and inpatients over the Christmas period using the appropriateness evaluation protocol (AEP).

    PubMed

    Henshaw; Pollock; Rai; Gluck

    2000-08-01

    The aim of the study was to examine appropriateness of admissions and inpatients over Christmas especially in the elderly. The study was a prospective audit of admissions and inpatients to the Whittington Hospital. The main outcome measures were appropriateness of admission or day of hospital residence using the Appropriateness Evaluation Protocol. The protocol was applied to admissions and inpatients over Christmas and control periods. The results showed that there was a significant difference in the number of elderly admissions between the control period and Christmas period, 94 (34%) vs. 104 (43%) (P=0.02). However there was no corresponding change in appropriateness of elderly admissions, ten (10.6%) vs. six (5.8%), (P=0.2). The inappropriateness of day of hospital residence increased from 10% on the control day to 20% on the study day (P=0.02). In conclusion elderly patients are not admitted more inappropriately over Christmas but their discharge at this time appears to be delayed resulting in inappropriate bed use.

  17. A future without health? Health dimension in global scenario studies.

    PubMed Central

    Martens, Pim; Huynen, Maud

    2003-01-01

    This paper reviews the health dimension and sociocultural, economic, and ecological determinants of health in existing global scenario studies. Not even half of the 31 scenarios reviewed gave a good description of future health developments and the different scenario studies did not handle health in a consistent way. Most of the global driving forces of health are addressed adequately in the selected scenarios, however, and it therefore would have been possible to describe the future developments in health as an outcome of these multiple driving forces. To provide examples on how future health can be incorporated in existing scenarios, we linked the sociocultural, economic, and environmental developments described in three sets of scenarios (special report on emission scenarios (SRES), global environmental outlook-3 (GEO3), and world water scenarios (WWS)) to three potential, but imaginary, health futures ("age of emerging infectious diseases", "age of medical technology", and "age of sustained health"). This paper provides useful insights into how to deal with future health in scenarios and shows that a comprehensive picture of future health evolves when all important driving forces and pressures are taken into account. PMID:14997242

  18. A web-based computer-tailored smoking prevention programme for primary school children: intervention design and study protocol

    PubMed Central

    2012-01-01

    Background Although the number of smokers has declined in the last decade, smoking is still a major health problem among youngsters and adolescents. For this reason, there is a need for effective smoking prevention programmes targeting primary school children. A web-based computer-tailored feedback programme may be an effective intervention to stimulate youngsters not to start smoking, and increase their knowledge about the adverse effects of smoking and their attitudes and self-efficacy regarding non-smoking. Methods & design This paper describes the development and evaluation protocol of a web-based out-of-school smoking prevention programme for primary school children (age 10-13 years) entitled ‘Fun without Smokes’. It is a transformation of a postal mailed intervention to a web-based intervention. Besides this transformation the effects of prompts will be examined. This web-based intervention will be evaluated in a 2-year cluster randomised controlled trial (c-RCT) with three study arms. An intervention and intervention + prompt condition will be evaluated for effects on smoking behaviour, compared with a no information control condition. Information about pupils’ smoking status and other factors related to smoking will be obtained using a web-based questionnaire. After completing the questionnaire pupils in both intervention conditions will receive three computer-tailored feedback letters in their personal e-mail box. Attitudes, social influences and self-efficacy expectations will be the content of these personalised feedback letters. Pupils in the intervention + prompt condition will - in addition to the personalised feedback letters - receive e-mail and SMS messages prompting them to revisit the ‘Fun without Smokes’ website. The main outcome measures will be ever smoking and the utilisation of the ‘Fun without Smokes’ website. Measurements will be carried out at baseline, 12 months and 24 months of follow-up. Discussion The present study

  19. Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE)

    PubMed Central

    2011-01-01

    Background Maternal smoking is the most significant cause of preventable complications during pregnancy, with smoking cessation during pregnancy shown to increase birth weight and reduce preterm birth among pregnant women who quit smoking. Taking into account the fact that the number of women who smoke in Greece has increased steadily throughout the previous decade and that the prevalence of smoking among Greek females is one of the highest in the world, smoking cessation should be a top priority among Greek health care professionals. Methods/Design The Maternal Smoking Cessation during Pregnancy Study (M-SCOPE), is a Randomized Control Trial (RCT) that aims to test whether offering Greek pregnant smokers a high intensity intervention increases smoking cessation during the third trimester of pregnancy, when compared to a low intensity intervention. Prospective participants will be pregnant smokers of more than 5 cigarettes per week, recruited up to the second trimester of pregnancy. Urine samples for biomarker analysis of cotinine will be collected at three time points: at baseline, at around the 32nd week of gestation and at six months post partum. The control group/low intensity intervention will include: brief advice for 5 minutes and a short leaflet, while the experimental group/intensive intervention will include: 30 minutes of individualized cognitive-behavioural intervention provided by a trained health professional and a self-help manual especially tailored for smoking cessation during pregnancy, while counselling will be based on the ''5 As.'' After childbirth, the infants' birth weight, gestational age and any other health related complications during pregnancy will be recorded. A six months post-partum a follow up will be performed in order to re-assess the quitters smoking status. Discussion If offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation in comparison to a usual care low intensity

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

    PubMed Central

    2012-01-01

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

  1. Testing a Theory-Based Mobility Monitoring Protocol Using In-Home Sensors: A Feasibility Study

    PubMed Central

    Reeder, Blaine; Chung, Jane; Lazar, Amanda; Joe, Jonathan; Demiris, George; Thompson, Hilaire J.

    2014-01-01

    Mobility is a key factor in the performance of many everyday tasks required for independent living as a person grows older. The purpose of this mixed methods study was to test a theory-based mobility monitoring protocol by comparing sensor-based measures to self-report measures of mobility and assessing the acceptability of in-home sensors with older adults. Standardized instruments to measure physical, psychosocial and cognitive parameters were administered to 8 community-dwelling older adults at baseline, 3 month and 6 month visits (examples: FES, GDS-SF, Mini-cog). Semi-structured interviews to characterize acceptability of the technology were conducted at 3 month and 6 month visits. Technical issues prevented comparison of sensor-based measures with self-report measures. In-home sensor technology for monitoring mobility is acceptable to older adults. Implementing our theory-based mobility monitoring protocol in a field study in the homes of older adults is a feasible undertaking but requires more robust technology for sensor-based measure validation. PMID:23938159

  2. Analysis of Requirements for the Medication Profile to Be Used in Clinical Research: Protocol Feasibility Studies and Patient Recruitment

    PubMed Central

    James, Julie M.; Kalra, Dipak; Portlock, Jane

    2015-01-01

    A “Medication Profile,” the information about the medicines a person is using and has used, is a core part of many electronic health record systems and summaries. However, there is little objective research into the data elements that the profile should contain to support the uses it must serve. With the increasing emphasis on secondary uses of electronic health information, as well as supporting the requirements to support direct to patient care, the Medication Profile should also support the requirements from clinical research. However, there is little, if any, description of these available. This paper describes an analysis of a set of study eligibility criteria that was undertaken to investigate which medication-related data elements would be required to support two clinical research use cases: the parameters to query a patient's Medication Profile to assess their suitability for entry into a trial (patient recruitment) and the parameters to query a set of Medication Profiles in a data warehouse to assess whether the eligibility criteria as described would yield a reasonable cohort of patients as potential subjects (protocol feasibility). These medication-related data elements then become information requirements that a Medication Profile should ideally meet, in order to be able to support these two uses in the clinical research domain. PMID:26539541

  3. Analysis of Requirements for the Medication Profile to Be Used in Clinical Research: Protocol Feasibility Studies and Patient Recruitment.

    PubMed

    James, Julie M; Kalra, Dipak; Portlock, Jane

    2015-01-01

    A "Medication Profile," the information about the medicines a person is using and has used, is a core part of many electronic health record systems and summaries. However, there is little objective research into the data elements that the profile should contain to support the uses it must serve. With the increasing emphasis on secondary uses of electronic health information, as well as supporting the requirements to support direct to patient care, the Medication Profile should also support the requirements from clinical research. However, there is little, if any, description of these available. This paper describes an analysis of a set of study eligibility criteria that was undertaken to investigate which medication-related data elements would be required to support two clinical research use cases: the parameters to query a patient's Medication Profile to assess their suitability for entry into a trial (patient recruitment) and the parameters to query a set of Medication Profiles in a data warehouse to assess whether the eligibility criteria as described would yield a reasonable cohort of patients as potential subjects (protocol feasibility). These medication-related data elements then become information requirements that a Medication Profile should ideally meet, in order to be able to support these two uses in the clinical research domain. PMID:26539541

  4. Data Resource Profile: The World Health Organization Study on global AGEing and adult health (SAGE)

    PubMed Central

    Kowal, Paul; Chatterji, Somnath; Naidoo, Nirmala; Biritwum, Richard; Fan, Wu; Lopez Ridaura, Ruy; Maximova, Tamara; Arokiasamy, Perianayagam; Phaswana-Mafuya, Nancy; Williams, Sharon; Snodgrass, J Josh; Minicuci, Nadia; D'Este, Catherine; Peltzer, Karl; Boerma, J Ties; Yawson, A.; Mensah, G.; Yong, J.; Guo, Y.; Zheng, Y.; Parasuraman, P.; Lhungdim, H.; Sekher, TV.; Rosa, R.; Belov, VB.; Lushkina, NP; Peltzer, K.; Makiwane, M.; Zuma, K.; Ramlagan, S.; Davids, A.; Mbelle, N.; Matseke, G.; Schneider, M.; Tabane, C.; Tollman, S.; Kahn, K.; Ng, N.; Juvekar, S.; Sankoh, O.; Debpuur, CY.; Nguyen, TK Chuc; Gomez-Olive, FX.; Hakimi, M.; Hirve, S.; Abdullah, S.; Hodgson, A.; Kyobutungi, C.; Egondi, T.; Mayombana, C.; Minh, HV.; Mwanyangala, MA.; Razzaque, A.; Wilopo, S.; Streatfield, PK.; Byass, P.; Wall, S.; Scholten, F.; Mugisha, J.; Seeley, J.; Kinyanda, E.; Nyirenda, M.; Mutevedzi, P.; Newell, M-L.

    2012-01-01

    Population ageing is rapidly becoming a global issue and will have a major impact on health policies and programmes. The World Health Organization’s Study on global AGEing and adult health (SAGE) aims to address the gap in reliable data and scientific knowledge on ageing and health in low- and middle-income countries. SAGE is a longitudinal study with nationally representative samples of persons aged 50+ years in China, Ghana, India, Mexico, Russia and South Africa, with a smaller sample of adults aged 18–49 years in each country for comparisons. Instruments are compatible with other large high-income country longitudinal ageing studies. Wave 1 was conducted during 2007–2010 and included a total of 34 124 respondents aged 50+ and 8340 aged 18–49. In four countries, a subsample consisting of 8160 respondents participated in Wave 1 and the 2002/04 World Health Survey (referred to as SAGE Wave 0). Wave 2 data collection will start in 2012/13, following up all Wave 1 respondents. Wave 3 is planned for 2014/15. SAGE is committed to the public release of study instruments, protocols and meta- and micro-data: access is provided upon completion of a Users Agreement available through WHO’s SAGE website (www.who.int/healthinfo/systems/sage) and WHO’s archive using the National Data Archive application (http://apps.who.int/healthinfo/systems/surveydata). PMID:23283715

  5. Data resource profile: the World Health Organization Study on global AGEing and adult health (SAGE).

    PubMed

    Kowal, Paul; Chatterji, Somnath; Naidoo, Nirmala; Biritwum, Richard; Fan, Wu; Lopez Ridaura, Ruy; Maximova, Tamara; Arokiasamy, Perianayagam; Phaswana-Mafuya, Nancy; Williams, Sharon; Snodgrass, J Josh; Minicuci, Nadia; D'Este, Catherine; Peltzer, Karl; Boerma, J Ties

    2012-12-01

    Population ageing is rapidly becoming a global issue and will have a major impact on health policies and programmes. The World Health Organization's Study on global AGEing and adult health (SAGE) aims to address the gap in reliable data and scientific knowledge on ageing and health in low- and middle-income countries. SAGE is a longitudinal study with nationally representative samples of persons aged 50+ years in China, Ghana, India, Mexico, Russia and South Africa, with a smaller sample of adults aged 18-49 years in each country for comparisons. Instruments are compatible with other large high-income country longitudinal ageing studies. Wave 1 was conducted during 2007-2010 and included a total of 34 124 respondents aged 50+ and 8340 aged 18-49. In four countries, a subsample consisting of 8160 respondents participated in Wave 1 and the 2002/04 World Health Survey (referred to as SAGE Wave 0). Wave 2 data collection will start in 2012/13, following up all Wave 1 respondents. Wave 3 is planned for 2014/15. SAGE is committed to the public release of study instruments, protocols and meta- and micro-data: access is provided upon completion of a Users Agreement available through WHO's SAGE website (www.who.int/healthinfo/systems/sage) and WHO's archive using the National Data Archive application (http://apps.who.int/healthinfo/systems/surveydata).

  6. Rigorous anaesthesia management protocol for patients with intracranial arterial stenosis: a prospective controlled-cohort study

    PubMed Central

    Laiwalla, Azim N; Ooi, Yinn Cher; Van De Wiele, Barbara; Ziv, Keren; Brown, Adam; Liou, Raymond; Saver, Jeffrey L; Gonzalez, Nestor R

    2016-01-01

    Objectives Reducing variability is integral in quality management. As part of the ongoing Encephaloduroarteriosynangiosis Revascularisation for Symptomatic Intracranial Arterial Stenosis (ERSIAS) trial, we developed a strict anaesthesia protocol to minimise fluctuations in patient parameters affecting cerebral perfusion. We hypothesise that this protocol reduces the intraoperative variability of targeted monitored parameters compared to standard management. Design Prospective cohort study of patients undergoing encephaloduroarteriosynangiosis surgery versus standard neurovascular interventions. Patients with ERSIAS had strict perioperative management that included normocapnia and intentional hypertension. Control patients received regular anaesthetic standard of care. Minute-by-minute intraoperative vitals were electronically collected. Heterogeneity of variance tests were used to compare variance across groups. Mixed-model regression analysis was performed to establish the effects of treatment group on the monitored parameters. Setting Tertiary care centre. Participants 24 participants: 12 cases (53.8 years±16.7 years; 10 females) and 12 controls (51.3 years±15.2 years; 10 females). Adults aged 30–80 years, with transient ischaemic attack or non-disabling stroke (modified Rankin Scale <3) attributed to 70–99% intracranial stenosis of the carotid or middle cerebral artery, were considered for enrolment. Controls were matched according to age, gender and history of neurovascular intervention. Main outcome measures Variability of heart rate, mean arterial blood pressure (MAP), systolic blood pressure and end tidal CO2 (ETCO2) throughout surgical duration. Results There were significant reductions in the intraoperative MAP SD (4.26 vs 10.23 mm Hg; p=0.007) and ETCO2 SD (0.94 vs 1.26 mm Hg; p=0.05) between the ERSIAS and control groups. Median MAP and ETCO2 in the ERSIAS group were higher (98 mm Hg, IQR 23 vs 75 mm Hg, IQR 15; p<0

  7. Protocol for Studying Extinction of Conditioned Fear in Naturally Cycling Female Rats

    PubMed Central

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

    2015-01-01

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

  8. Study of streptomycin-induced ototoxicity: protocol for a longitudinal study.

    PubMed

    Adeyemo, Adebolajo A; Oluwatosin, Odunayo; Omotade, Olayemi O

    2016-01-01

    Hearing impairment is due to various causes including ototoxicity from aminoglycosides. The susceptibility to aminoglycosides increases in the presence of certain mitochondria gene mutations. There is unrestrained use of aminoglycosides in many developing nations which may worsen the burden of hearing impairment in these countries but there is lack of data to drive required policy changes. Streptomycin (an aminoglycoside) is part of the drug regimen in re-treatment of tuberculosis. Exploring the impact of streptomycin ototoxicity in tuberculosis patients provides a unique opportunity to study aminoglycoside ototoxicity within the population thus providing data that can inform policy. Also, since streptomycin ototoxicity could adversely affect treatment adherence in tuberculosis patients this study could enable better pre-treatment counseling with subsequent better treatment adherence. Patients on tuberculosis re-treatment will be recruited longitudinally from Direct Observation Therapy-Short course centers. A baseline full audiologic assessment will be done before commencement of treatment and after completion of treatment. Early detection of ototoxicity will be determined using the American Speech and Hearing Association criteria and genetic analysis to determine relevant mitochondria gene mutations will be done. The incidence of ototoxicity in the cohort will be analyzed. Both Kaplan-Meier survival curve and Cox proportional hazards tests will be utilized to determine factors associated with development of ototoxicity and to examine association between genotype status and ototoxicity. This study will provide data on the burden and associated predictors of developing aminoglycoside induced ototoxicity. This will inform public health strategies to regulate aminoglycoside usage and optimization of treatment adherence and the management of drug-induced ototoxicity among TB patients. Furthermore the study will describe mitochondrial gene mutations associated with

  9. Tackling inequalities in obesity: a protocol for a systematic review of the effectiveness of public health interventions at reducing socioeconomic inequalities in obesity amongst children

    PubMed Central

    2012-01-01

    Background There is growing evidence of the impact of overweight and obesity on short- and long-term functioning, health and well-being. Internationally, childhood obesity rates continue to rise in some countries (for example, Mexico, India, China and Canada), although there is emerging evidence of a slowing of this increase or a plateauing in some age groups. In most European countries, the United States and Australia, however, socioeconomic inequalities in relation to obesity and risk factors for obesity are widening. Addressing inequalities in obesity, therefore, has a very high profile on the public health and health services agendas. However, there is a lack of accessible policy-ready evidence on what works in terms of interventions to reduce inequalities in obesity. Methods and design This article describes the protocol for a National Health Service Trust (NHS) National Institute for Health Research-funded systematic review of public health interventions at the individual, community and societal levels which might reduce socioeconomic inequalities in relation to obesity amongst children ages 0 to 18 years. The studies will be selected only if (1) they included a primary outcome that is a proxy for body fatness and (2) examined differential effects with regard to socioeconomic status (education, income, occupation, social class, deprivation and poverty) or the intervention was targeted specifically at disadvantaged groups (for example, children of the unemployed, lone parents, low income and so on) or at people who live in deprived areas. A rigorous and inclusive international literature search will be conducted for randomised and nonrandomised controlled trials, prospective and retrospective cohort studies (with and/or without control groups) and prospective repeat cross-sectional studies (with and/or without control groups). The following electronic databases will be searched: MEDLINE, Embase, CINAHL, PsycINFO, Social Science Citation Index, ASSIA, IBSS

  10. Effect of an analgo-sedation protocol for neurointensive patients: a two-phase interventional non-randomized pilot study

    PubMed Central

    2010-01-01

    Introduction Sedation protocols are needed for neurointensive patients. The aim of this pilot study was to describe sedation practice at a neurointensive care unit and to assess the feasibility and efficacy of a new sedation protocol. The primary outcomes were a shift from sedation-based to analgesia-based sedation and improved pain management. The secondary outcomes were a reduction in unplanned extubations and duration of sedation. Methods This was a two-phase (before-after), prospective controlled study at a university-affiliated, 14-bed neurointensive care unit in Denmark. The sample included patients requiring mechanical ventilation for at least 48 hours treated with continuous sedative and analgesic infusions or both. During the observation phase the participants (n = 106) were sedated as usual (non-protocolized), and during the intervention phase the participants (n = 109) were managed according to a new sedation protocol. Results Our study showed a shift toward analgo-sedation, suggesting feasibility of the protocol. We found a significant reduction in the use of propofol (P < .001) and midazolam (P = .001) and an increase in fentanyl (P < .001) and remifentanil (P = .003). Patients selected for daily sedation interruption woke up faster, and estimates of pain free patients increased from 56.8% to 82.7% (P < .001), suggesting efficacy of the protocol. The duration of sedation and unplanned extubations were unchanged. Conclusions Our pilot study showed feasibility and partial efficacy of our protocol. Some neurointensive patients might not benefit from protocolized practice. We recommend an interdisciplinary effort to target patients requiring less sedation, as issues of oversedation and inadequate pain management still need more attention. Trial registration ISRCTN80999859. PMID:20403186

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

    PubMed

    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.

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

    PubMed Central

    Alanazi, Adwan; Elleithy, Khaled

    2015-01-01

    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. PMID:26364639

  13. The effectiveness of mHealth interventions for maternal, newborn and child health in low– and middle–income countries: Protocol for a systematic review and meta–analysis

    PubMed Central

    Nurmatov, Ulugbek B.; Lee, Siew H.; Nwaru, Bright I.; Mukherjee, Mome; Grant, Liz; Pagliari, Claudia

    2014-01-01

    Introduction Rates of maternal, newborn and child (MNCH) mortality and morbidity are vastly greater in low– than in high–income countries and represent a major source of global health inequity. A host of systemic, economic, geopolitical and sociocultural factors have been implicated. Mobile information and communication technologies hold potential to ameliorate several of these challenges by supporting coordinated and evidence–based care, facilitating community based health services and enabling citizens to access health information and support. mHealth has attracted considerable attention as a means of supporting maternal, newborn and child health in developing countries and research to assess the impacts of mHealth interventions is increasing. While a number of expert reviews have attempted to summarise this literature, there remains a need for a fully systematic review employing gold standard methods of evidence capture, critical appraisal and meta–analysis, in order to comprehensively map, quality assess and synthesise this body of knowledge. Objectives To undertake a systematic review and meta–analysis of studies evaluating the impacts of mobile technology–enabled interventions designed to support maternal, newborn and child health in low– and middle–income countries. Methods 16 online international electronic databases of published scientific abstracts and citations will be interrogated for the period 1990 to 2014 (no language restrictions) in order to identify relevant studies. Ongoing/unpublished studies will be identified through searching international trial repositories and consulting experts in the field. Study quality will be assessed using appropriate critical appraisal tools; including the Cochrane Handbook’s 7 evaluation domains for randomised and clinical trials, the Cochrane Effective Practice and Organisation of Care (EPOC) guidelines for other comparative study types, and the Effective Public Health Practice Project (EPHPP

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

    PubMed

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

    2015-12-01

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

  15. The HALO submaximal treadmill protocol to measure cardiorespiratory fitness in obese children and youth: a proof of principle study.

    PubMed

    Breithaupt, Peter; Adamo, Kristi B; Colley, Rachel C

    2012-04-01

    Many limitations exist with completing cardiorespiratory fitness testing in obese children. The aim of this study was to determine if the new Healthy Active Living and Obesity Research Group's (HALO's) submaximal cardiorespiratory fitness testing protocol for obese children and youth provides a comparable estimate of peak oxygen uptake to that measured using validated maximal and submaximal, equation-based protocols in the obese pediatric population. A group of obese children (n = 21; all ≥95th body mass index percentile; aged 10-17 years) completed 3 exercise testing protocols. Testing was completed as part of an ongoing cohort study and 2 submaximal cardiorespiratory fitness tests were completed, in randomized order, during a second visit. Significant correlations were found between observed peak oxygen uptake (mL·min(-1)) and predicted peak oxygen uptake for both the HALO (r = 0.75, p = 0.001) and Nemeth (r = 0.66, p = 0.001) submaximal protocols. A similar correlation was found, after accounting for body mass, between measured and predicted HALO peak oxygen uptake (mL·kg(-1)·min(-1)) values (r = 0.54, p = 0.01). HALO predicted peak oxygen uptake values showed a significant correlation when plotted against the measured values (r = 0.99). A Bland-Altman analysis found agreement between the maximal and HALO submaximal protocols (mean bias = -201.75 mL·min(-1)). The significant relationships found between estimates of peak oxygen uptake from the HALO submaximal protocol and measures of peak oxygen uptake during maximal cardiorespiratory testing support the use of the HALO submaximal protocol as a valid measure to estimate maximal cardiorespiratory fitness within the obese pediatric population. Given the proof of principle goal of this study, future research in the obese, pediatric population is encouraged to confirm the generalizability of the protocol.

  16. Description and factors of variation of the overall health score in French dairy cattle herds using the Welfare Quality(®) assessment protocol.

    PubMed

    Coignard, M; Guatteo, R; Veissier, I; de Boyer des Roches, A; Mounier, L; Lehébel, A; Bareille, N

    2013-11-01

    Extensive information is available in the literature on the specific risk factors of the main health disorders afflicting dairy cattle herds. However, it remains difficult to manage a herd's overall health because measures to control one risk factor can exacerbate the risk of another disease. To achieve and maintain good overall herd health, livestock systems and management practices need to simultaneously take into account all of the main health disorders. We aimed to identify the characteristics of systems and practices conducive to good herd health using the Welfare Quality(®) assessment protocol for cattle. This protocol allows an assessment of the level of health and welfare at the herd level according to the opinion of a selected group of 13 experts from animal sciences. Our objectives were to (i) describe the distribution of dairy herds' health scores in a representative sample of French dairy cattle herds, and (ii) to investigate systems (housing system, milking system, herd size, breed, farm location) and management practices associated with variations of the overall health score of dairy herds. This protocol was carried out on 130 farms between December 2010 and March 2011. A multivariable analysis of variance (ANOVA) was performed to investigate the factors of variation of the overall health score at the herd level. The overall health scores of the farms in the sample were classified as moderate for the vast majority of farms (95.4%) (mainly due to subclinical mastitis, dystocia and pain induced by disbudding/dehorning) and varied little between farms. Some livestock systems were associated with a higher overall health score: straw yards and milking parlors (P<0.0001), highland vs. lowland locations (P=0.013), Montbeliarde rather than Holstein breeds (P=0.006). Some management practices also were associated with a higher level of health: medium herd average parity (P=0.03), low proportion of dirty cows (P=0.002) and low proportion of cows with abnormal

  17. Alabama Allied Health Needs Assessment Study.

    ERIC Educational Resources Information Center

    Morris, Libby V.

    This study assessed the supply of and demand for allied health professionals in Alabama, focusing on the relationship between supply and demand in various workplace settings in the context of Alabama's demographics, current educational programs, and projected changes in health care. The health care professions included in the study were all fields…

  18. A Pilot Study for Applying an Extravehicular Activity Exercise Prebreathe Protocol to the International Space Station

    NASA Technical Reports Server (NTRS)

    Woodruff, Kristin K.; Johnson, Anyika N.; Lee, Stuart M. C.; Gernhardt, Michael; Schneider, Suzanne M.; Foster, Philip P.

    2000-01-01

    Decompression sickness (DCS) is a serious risk to astronauts performing extravehicular activity (EVA). To reduce this risk, the addition of ten minutes of moderate exercise (75% VO2pk) during prebreathe has been shown to decrease the total prebreathe time from 4 to 2 hours and to decrease the incidence of DCS. The overall purpose of this pilot study was to develop an exercise protocol using flight hardware and an in-flight physical fitness cycle test to perform prebreathe exercise before an EVA. Eleven subjects volunteered to participate in this study. The first objective of this study was to compare the steady-state heart rate (HR) and oxygen consumption (VO2) from a submaximal arm and leg exercise (ALE) session with those predicted from a maximal ALE test. The second objective was to compare the steady-state HR and V02 from a submaximal elastic tube and leg exercise (TLE) session with those predicted from the maximal ALE test. The third objective involved a comparison of the maximal ALE test with a maximal leg-only (LE) test to conform to the in- flight fitness assessment test. The 75% VO2pk target HR from the LE test was significantly less than the target HR from the ALE test. Prescribing exercise using data from the maximal ALE test resulted in the measured submaximal values being higher than predicted VO2 and HR. The results of this pilot study suggest that elastic tubing is valid during EVA prebreathe as a method of arm exercise with the flight leg ergometer and it is recommended that prebreathe countermeasure exercise protocol incorporate this method.

  19. Prospective randomized study of D-Trp6-LHRH versus buserelin in long desensitization protocols for medically assisted conception cycles.

    PubMed

    Gianaroli, L; Ferraretti, A P; Feliciani, E; Tabanelli, C; Magli, C; Fortini, D

    1994-02-01

    In a prospective, controlled, randomized study where two different agonists were used, we compared three different long desensitization protocols for induction of multiple follicular growth in medically assisted conception cycles. In protocol A, 30 patients were injected with buserelin twice a day for 15 days prior to ovarian stimulation until human chorionic gonadotrophin (HCG) administration. In protocol B, 30 patients were injected with a single dose of long acting Triptorelin (3.75 mg) 15 days before the ovarian stimulation onset. In protocol C, 30 patients were injected with the long acting Triptorelin 4 weeks before ovarian stimulation followed by daily administration of 0.1 mg of the same agonist until HCG injection. There was no difference in the ovarian response to exogenous gonadotrophin stimulation, except for the presence of premature luteinization in two patients in group B. A significantly higher number of mature oocytes was collected from patients with protocol A; however, the fertilization and cleavage rate demonstrated no significant difference among the three groups of patients. The ongoing pregnancy rate and the implantation rate per treatment cycle were very similar in the three study groups. When the convenience, cost and side-effects for the patient are being considered, protocol B should be selected as the first choice when the agonist is utilized for the purpose of inducing pituitary desensitization before and during ovarian stimulation.

  20. Accuracy of NHANES periodontal examination protocols.

    PubMed

    Eke, P I; Thornton-Evans, G O; Wei, L; Borgnakke, W S; Dye, B A

    2010-11-01

    This study evaluates the accuracy of periodontitis prevalence determined by the National Health and Nutrition Examination Survey (NHANES) partial-mouth periodontal examination protocols. True periodontitis prevalence was determined in a new convenience sample of 454 adults ≥ 35 years old, by a full-mouth "gold standard" periodontal examination. This actual prevalence was compared with prevalence resulting from analysis of the data according to the protocols of NHANES III and NHANES 2001-2004, respectively. Both NHANES protocols substantially underestimated the prevalence of periodontitis by 50% or more, depending on the periodontitis case definition used, and thus performed below threshold levels for moderate-to-high levels of validity for surveillance. Adding measurements from lingual or interproximal sites to the NHANES 2001-2004 protocol did not improve the accuracy sufficiently to reach acceptable sensitivity thresholds. These findings suggest that NHANES protocols produce high levels of misclassification of periodontitis cases and thus have low validity for surveillance and research.

  1. PELICAN: A quality of life instrument for childhood asthma: Study Protocol of two Randomized Controlled Trials in Primary and Specialized Care in the Netherlands

    PubMed Central

    2012-01-01

    Background Asthma is one of the major chronic health problems in children in the Netherlands. The Pelican is a paediatric asthma-related quality of life instrument for children with asthma from 6–11 years old, which is suitable for clinical practice in primary and specialized care. Based on this instrument, we developed a self-management treatment to improve asthma-related quality of life. The Pelican intervention will be investigated in different health care settings. Results of intervention studies are often extrapolated to other health care settings than originally investigated. Because of differences in organization, disease severity, patient characteristics and care provision between health care settings, extrapolating research results could lead to unnecessary health costs without the desired health care achievements. Therefore, interventions have to be investigated in different health care settings when possible. This study is an example of an intervention study in different health care settings. In this article, we will present the study protocol of the Pelican study in primary and specialized care. Method/design This study consists of two randomized controlled trials to assess the effectiveness of the Pelican intervention in primary and specialized care. The trial in primary care is a multilevel design with 170 children with asthma in 16 general practices. All children in one general practices are allocated to the same treatment group. The trial in specialized care is a multicentre trial with 100 children with asthma. Children in one outpatient clinic are randomly allocated to the intervention or usual care group. In both trials, children will visit the care provider four times during a follow-up of nine months. This study is registered and ethically approved. Discussion This article describes the study protocol of the Pelican study in different health care settings. If the Pelican intervention proves to be effective and efficient, implementation in

  2. Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial

    PubMed Central

    Wright, Barry; Tindall, Lucy; Littlewood, Elizabeth; Adamson, Joy; Allgar, Victoria; Bennett, Sophie; Gilbody, Simon; Verduyn, Chrissie; Alderson-Day, Ben; Dyson, Lisa; Trépel, Dominic; Ali, Shehzad

    2014-01-01

    Introduction The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT). Methods and analysis Adolescents aged 12–18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate ‘numbers needed’ to plan a fully powered RCT of clinical and cost-effectiveness. Ethics and

  3. Reference gene selection and RNA preservation protocol in the cat flea, Ctenocephalides felis, for gene expression studies.

    PubMed

    McIntosh, Catriona H; Baird, John; Zinser, Erich; Woods, Debra J; Campbell, Ewan M; Bowman, Alan S

    2016-10-01

    The cat flea, Ctenocephalides felis, is a major pest species on companion animals thus of significant importance to the animal health industry. The aim of this study was to develop sampling and storage protocols and identify stable reference genes for gene expression studies to fully utilize the growing body of molecular knowledge of C. felis. RNA integrity was assessed in adult and larvae samples, which were either pierced or not pierced and stored in RNAlater at ambient temperature. RNA quality was maintained best in pierced samples, with negligible degradation evident after 10 days. RNA quality from non-pierced samples was poor within 3 days. Ten candidate reference genes were evaluated for their stability across four group comparisons (developmental stages, genders, feeding statuses and insecticide-treatment statuses). Glyceraldehyde 3 phosphate dehydrogenase (GAPDH), 60S ribosomal protein L19 (RPL19) and elongation factor-1α (Ef) were ranked highly in all stability comparisons, thus are recommended as reference genes under similar conditions. Employing just two of these three stable reference genes was sufficient for accurate normalization. Our results make a significant contribution to the future of gene expression studies in C. felis, describing validated sample preparation procedures and reference genes for use in this common pest.

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

    PubMed Central

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

    2016-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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. PMID:27207621

  5. “Vitamin D supplementation and bone health in adults with diabetic nephropathy: the protocol for a randomized controlled trial”

    PubMed Central

    2014-01-01

    Background Suboptimal vitamin D status is highly prevalent in Northern communities, particularly in those patients with chronic diseases such as diabetes and chronic renal disease. Emerging literature suggests that adherence to daily vitamin D supplementation may be an important factor influencing vitamin D status and overall bone health, but compliance with therapies for bone health is a major challenge. It is unknown what level of vitamin D supplementation will ameliorate or improve suboptimal vitamin D status in patients with diabetic nephropathy or contribute to improved bone health, particularly for those living in northern climates. Methods/Design The study purpose was to examine two different strategies of vitamin D3 supplementation; daily dosing of 2000 IU per day verses monthly dosing of 40,000 IU per month on markers of vitamin D status, bone health and to examine whether adherence, quality of life and patient satisfaction with the supplementation strategy differs between the two vitamin D strategies in adults diagnosed with diabetic nephropathy. Discussion The need for RCTs assessing higher doses of vitamin D3 supplementation at varying frequencies of administration and its impact on bone health in adults with diabetes and chronic kidney disease are needed. Trial registration ClinicalTrials.gov NCT01476501. PMID:25115438

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

    PubMed

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

    2010-05-01

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

  7. A Randomized Controlled Study to Compare Conventional and Evidence Based Treatment Protocols in Fresh Compound Fractures

    PubMed Central

    Mahajan, Kanika; Singh, Girish Kumar; Kumar, Santosh; Avasthi, Sachin

    2016-01-01

    Introduction A recent concept review in Journal of Bone and Joint Surgery (JBJS) outlines evidence to control peri-operative infections in compound fractures. However, evidence for impact of adopting a protocol combining measures that have some evidence is lacking in literature. The present method of treatment at King George’s Medical University (KGMU) is representative of the conventional practice of managing compound fractures in India and is an appropriate control for trial against the Experimental Evidence Based Protocol (EBP). Aim To study the additional impact of adopting Evidence Based Protocol on parameters defining infection rate and bone union. Materials and Methods This randomized controlled study was conducted at the orthopaedics department of KGMU. Two hundred and twenty six patients of compound fractures of both bone leg, age > 12y were randomized to two groups. One group received standard treatment and the experimental group received treatment as per JBJS review. Statistical Analysis Random allocation was tested by comparing baseline characteristics of the two groups. The two groups were compared for all the outcome variables in terms of time to a negative wound culture, time to wound healing, time to union at fracture site and time to achieve complete range of motion at knee joint. Results Random allocation was successful. EBP group reported significantly lesser time to a negative culture report from wound (mean in conventional=4.619, experimental=1.9146, p=0.0006), lesser time to bony union (mean in conventional=23.8427 weeks, experimental=22.8125 weeks, p=0.0027), lesser time to wound healing (mean in conventional=14.4425 weeks experimental=10.4513 weeks, p=0.0032), and a lesser duration of hospital stay (mean in conventional=6.5982 days, experimental=4.5000 days, p=0.0343). Conclusion EBP based on the guidelines suggested by Fletcher et al., significantly shorten the time taken for achieving a negative culture and hasten wound and fracture

  8. The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial

    PubMed Central

    White, David; Waugh, Norman; Elliott, Jackie; Lawton, Julia; Barnard, Katharine; Campbell, Michael J; Dixon, Simon; Heller, Simon

    2014-01-01

    Introduction People with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education. Methods and analysis A multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2 years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24 months in those participants whose baseline HbA1c is at or above 7.5% (58 mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58 mmol/mol) or less at 24 months. Ethics and dissemination The protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R

  9. Study protocol: a multi-professional team intervention of physical activity referrals in primary care patients with cardiovascular risk factors—the Dalby lifestyle intervention cohort (DALICO) study

    PubMed Central

    2012-01-01

    Background The present study protocol describes the trial design of a primary care intervention cohort study, which examines whether an extended, multi-professional physical activity referral (PAR) intervention is more effective in enhancing and maintaining self-reported physical activity than physical activity prescription in usual care. The study targets patients with newly diagnosed hypertension and/or type 2 diabetes. Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose; physical fitness and anthropometric variables; mental health; health related quality of life; and cost-effectiveness. Methods/Design The study is designed as a long-term intervention. Three primary care centres are involved in the study, each constituting one of three treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR, 2) Control group A (CA): physical activity prescription in usual care and 3) Control group B: treatment as usual (retrospective data collection). The intervention is based on self-determination theory and follows the principles of motivational interviewing. The primary outcome, physical activity, is measured with the International Physical Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as health behaviours; health-related quality of life; motivation to change; mental health; demographics and socioeconomic characteristics are assessed with an electronic study questionnaire that submits all data to a patient database, which automatically provides feed-back to the health-care providers on the patients’ health status. Cost-effectiveness of the intervention is evaluated continuously and the intermediate outcomes of the intervention are extrapolated by economic modelling. Discussions By helping patients to overcome practical, social and cultural obstacles and increase

  10. Considerations in establishing a post-mortem brain and tissue bank for the study of myalgic encephalomyelitis/chronic fatigue syndrome: a proposed protocol

    PubMed Central

    2014-01-01

    Background Our aim, having previously investigated through a qualitative study involving extensive discussions with experts and patients the issues involved in establishing and maintaining a disease specific brain and tissue bank for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), was to develop a protocol for a UK ME/CFS repository of high quality human tissue from well characterised subjects with ME/CFS and controls suitable for a broad range of research applications. This would involve a specific donor program coupled with rapid tissue collection and processing, supplemented by comprehensive prospectively collected clinical, laboratory and self-assessment data from cases and controls. Findings We reviewed the operations of existing tissue banks from published literature and from their internal protocols and standard operating procedures (SOPs). On this basis, we developed the protocol presented here, which was designed to meet high technical and ethical standards and legal requirements and was based on recommendations of the MRC UK Brain Banks Network. The facility would be most efficient and cost-effective if incorporated into an existing tissue bank. Tissue collection would be rapid and follow robust protocols to ensure preservation sufficient for a wide range of research uses. A central tissue bank would have resources both for wide-scale donor recruitment and rapid response to donor death for prompt harvesting and processing of tissue. Conclusion An ME/CFS brain and tissue bank could be established using this protocol. Success would depend on careful consideration of logistic, technical, legal and ethical issues, continuous consultation with patients and the donor population, and a sustainable model of funding ideally involving research councils, health services, and patient charities. This initiative could revolutionise the understanding of this still poorly-understood disease and enhance development of diagnostic biomarkers and treatments

  11. Prediction of (19)F NMR Chemical Shifts in Labeled Proteins: Computational Protocol and Case Study.

    PubMed

    Isley, William C; Urick, Andrew K; Pomerantz, William C K; Cramer, Christopher J

    2016-07-01

    The structural analysis of ligand complexation in biomolecular systems is important in the design of new medicinal therapeutic agents; however, monitoring subtle structural changes in a protein's microenvironment is a challenging and complex problem. In this regard, the use of protein-based (19)F NMR for screening low-molecular-weight molecules (i.e., fragments) can be an especially powerful tool to aid in drug design. Resonance assignment of the protein's (19)F NMR spectrum is necessary for structural analysis. Here, a quantum chemical method has been developed as an initial approach to facilitate the assignment of a fluorinated protein's (19)F NMR spectrum. The epigenetic "reader" domain of protein Brd4 was taken as a case study to assess the strengths and limitations of the method. The overall modeling protocol predicts chemical shifts for residues in rigid proteins with good accuracy; proper accounting for explicit solvation of fluorinated residues by water is critical. PMID:27218275

  12. Characterization of the Context of Drug Concepts in Research Protocols: An Empiric Study to Guide Ontology Development

    PubMed Central

    Cimino, James J.; Huser, Vojtech

    2015-01-01

    We examined a large body of research study documents (protocols) to identify mentions of drug concepts and established base concepts and roles needed to characterize the semantics of these instances. We found these concepts in three general situations: background knowledge about the drug, study procedures involving the drug, and other roles of the drug in the study. We identified 18 more specific contexts (e.g., adverse event information, administration and dosing of the drug, and interactions between the study drug and other drugs). The ontology was validated against a test set of protocol documents from NIH and ClinicalTrial.gov. The goal is to support the automated extraction of drug information from protocol documents to support functions such as study retrieval, determination of subject eligibility, generation of order sets, and creation of logic for decision support alerts and reminders. Further work is needed to formally extend existing ontologies of clinical research. PMID:26958176

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

    PubMed Central

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

    2016-01-01

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

  14. MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Ravn, Henrik; Batista, Celso Soares Pereira; Rodrigues, Amabelia

    2016-01-01

    Background Recent studies have revealed a low measles vaccination (MV) rate in the Republic of Guinea-Bissau (West Africa) that has not increased in accordance with the increasing coverage of other vaccinations. Measles is the deadliest of all childhood rash/fever illnesses and spreads easily, implying that if the vaccination coverage is declining there is a significant risk of new measles outbreaks [27]. Meanwhile, mobile health (mHealth; the use of mobile phones for health interventions) has generated much enthusiasm, and shown potential in improving health service delivery in other contexts. Objective The aim of this study is to evaluate the efficiency of mHealth as a tool for improving MV coverage while contributing to the mHealth evidence base. Methods This study will take place at three health centers in different regions of Guinea-Bissau. Participants, defined as mothers of the children receiving the MV, will be enrolled when they arrive with their children at the health center to receive the Bacillus Calmette-Guérin vaccination, usually within one month of the child’s birth. Enrolment will continue until a study population of 990 children has been reached. The participants will be randomly assigned to a control arm or one of two intervention arms. Each of the three groups will have 330 participants, distributed equally between health centers. Participants in the first intervention arm will receive a scheduled short message service (SMS) text message reminding them of the MV. Participants in the second intervention arm will receive a voice call in addition to the SMS message, while the control arm will receive no interventions. The MV is scheduled to be administered at 9 months of age. Although the vaccine would still be effective after 12 months, local policy in Guinea-Bissau prevents children aged >12 months from receiving the vaccination, and thus the study will follow-up with participants after the children reach 12 months of age. Children who have

  15. Work Smarter, Not Harder: Structured Reflection Protocol. Listening to Student Voices Self-Study Toolkit. [Videotape].

    ERIC Educational Resources Information Center

    Appalachia Educational Lab., Charleston, WV.

    This 19-minute VHS videotape introduces the structured reflection protocol, a tool designed to help teachers learn by working together and by using student work as a beginning point for their learning together. The videotape shows scenes of the structured reflection protocol being used in diverse school settings (elementary, secondary, rural,…

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

    PubMed Central

    Klußmann, André; Gebhardt, Hansjuergen; Liebers, Falk; von Engelhardt, Lars Victor; Dávid, Andreas; Bouillon, Bertil; Rieger, Monika A

    2008-01-01

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

  17. A multicenter study on the appropriateness of hospitalization in obstetric wards: application of Obstetric Appropriateness Evaluation Protocol (Obstetric AEP).

    PubMed

    Mannocci, Alice; Specchia, Maria Lucia; Poppa, Giuseppina; Boccia, Giovanni; Cavallo, Pierpaolo; De Caro, Francesco; Vetrano, Giuseppe; Aleandri, Vincenzo; Capunzo, Mario; Ricciardi, Walter; Boccia, Antonio; Firenze, Alberto; Malvasi, Antonio; La Torre, Giuseppe

    2015-09-01

    The cross-sectional study has been based on the implementation of the Obstetric Appropriateness Evaluation Protocol (OAEP) in seven hospitals to determine inappropriate hospital admissions and days of stay. The outcomes were: inappropriateness of admission and "percentage of inappropriateness" for one hospitalization. A total number of 2196 clinical records were reviewed. The mean percentage of inappropriateness for hospitalization was 22%. The percentage of inappropriateness for the first 10 d of hospitalization peaked in correspondence of the fourth (42%). The logistic regression model on inappropriated admission reported that emergency admission was a protective factor (OR = 0.4) and to be hospitalized in wards with ≥30 beds risk factor (OR = 5.12). The second linear model on "percentage of inappropriateness" showed that inappropriated admission and wards with ≥30 beds increased the percentage (p < 0.001); whereas the admission in Teaching Hospitals was inversely associated (p < 0.001). The present study suggests that the percentage of inappropriate admission depends especially on the inappropriate admission and the large number of beds in obstetric wards. This probably indicates that management of big hospitals, which is very complex, needs improving the processes of support and coordination of health professionals. The OAEP tool seems to be an useful instrument for the decision-makers to monitor and manage the obstetric wards.

  18. How to design in situ studies: an evaluation of experimental protocols

    PubMed Central

    Sung, Young-Hye; Kim, Hae-Young; Son, Ho-Hyun

    2014-01-01

    Objectives Designing in situ models for caries research is a demanding procedure, as both clinical and laboratory parameters need to be incorporated in a single study. This study aimed to construct an informative guideline for planning in situ models relevant to preexisting caries studies. Materials and Methods An electronic literature search of the PubMed database was performed. A total 191 of full articles written in English were included and data were extracted from materials and methods. Multiple variables were analyzed in relation to the publication types, participant characteristics, specimen and appliance factors, and other conditions. Frequencies and percentages were displayed to summarize the data and the Pearson's chi-square test was used to assess a statistical significance (p < 0.05). Results There were many parameters commonly included in the majority of in situ models such as inclusion criteria, sample sizes, sample allocation methods, tooth types, intraoral appliance types, sterilization methods, study periods, outcome measures, experimental interventions, etc. Interrelationships existed between the main research topics and some parameters (outcome measures and sample allocation methods) among the evaluated articles. Conclusions It will be possible to establish standardized in situ protocols according to the research topics. Furthermore, data collaboration from comparable studies would be enhanced by homogeneous study designs. PMID:25110639

  19. Challenges of health measurement in studies of health disparities.

    PubMed

    Burgard, Sarah A; Chen, Patricia V

    2014-04-01

    Health disparities are increasingly studied in and across a growing array of societies. While novel contexts and comparisons are a promising development, this commentary highlights four challenges to finding appropriate and adequate health measures when making comparisons across groups within a society or across distinctive societies. These challenges affect the accurac