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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 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. A trial of a job-specific workers' health surveillance program for construction workers: study protocol

    PubMed Central

    2011-01-01

    Background Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS) to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. Methods/Design The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS) group (n = 206) with that of a control (WHS) group (n = 206). The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. Discussion This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the preventive actions

  9. 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

  10. Japanese Study on Stratification, Health, Income, and Neighborhood: Study Protocol and Profiles of Participants

    PubMed Central

    Takada, Misato; Kondo, Naoki; Hashimoto, Hideki

    2014-01-01

    Background The Japanese Study on Stratification, Health, Income, and Neighborhood (J-SHINE) aims to clarify the complex associations between social factors and health from an interdisciplinary perspective and to provide a database for use in various health policy evaluations. Methods J-SHINE is an ongoing longitudinal panel study of households of adults aged 25–50 years. The wave 1 survey was carried out in 2010 among adults randomly selected from the resident registry of four urban and suburban municipalities in the greater Tokyo metropolitan area, Japan. In 2011, surveys for the participants’ spouse/partner and child were additionally conducted. The wave 2 survey was conducted in 2012 for the wave 1 participants and will be followed by the wave 2 survey for spouse/partner and child in 2013. Results Wave 1 sample sizes were 4357 for wave 1 participants (valid response rate: 31.3%; cooperation rate: 51.8%), 1873 for spouse/partner (response rate: 61.9%), and 1520 for child (response rate: 67.7%). Wave 2 captured 69.0% of wave 1 participants. Information gathered covered socio-demographics, household economy, self-reported health conditions and healthcare utilization, stress and psychological values, and developmental history. A subpopulation underwent physiological (n = 2468) and biomarker (n = 1205) measurements. Conclusions Longitudinal survey data, including repeated measures of social factors evaluated based on theories and techniques of various disciplines, like J-SHINE, should contribute toward opening a web of causality for society and health, which may have important policy implications for recent global health promotion strategies such as the World Health Organization’s Social Determinants of Health approach and the second round of Japan’s Healthy Japan 21. PMID:24814507

  11. Midlife women, bone health, vegetables, herbs and fruit study. The Scarborough Fair study protocol

    PubMed Central

    2013-01-01

    Background Bone loss is accelerated in middle aged women but increased fruit/vegetable intake positively affects bone health by provision of micronutrients essential for bone formation, buffer precursors which reduce acid load and phytochemicals affecting inflammation and oxidative stress. Animal studies demonstrated bone resorption inhibiting properties of specific vegetables, fruit and herbs a decade ago. Objective: To increase fruit/vegetable intake in post menopausal women to 9 servings/day using a food specific approach to significantly reduce dietary acid load and include specific vegetables, fruit and herbs with bone resorbing inhibiting properties to assess effect on bone turnover, metabolic and inflammatory markers. Methods/Design The Scarborough Fair Study is a randomised active comparator controlled multi centre trial. It aimed to increase fruit and vegetable intake in 100 post menopausal women from ≤ 5 servings/day to ≥ 9 servings/day for 3 months. The women in the dietary intervention were randomly assigned to one of the two arms of the study. Both groups consumed ≥ 9 servings/day of fruit/vegetables and selected herbs but the diet of each group emphasised different fruit/vegetables/herbs with one group (B) selecting from a range of vegetables, fruit and culinary herbs with bone resorbing inhibiting properties. 50 women formed a negative control group (Group C usual diet). Primary outcome variables were plasma bone markers assessed at baseline, 6 weeks and 12 weeks. Secondary outcome variables were plasma inflammation and metabolic markers and urinary electrolytes (calcium, magnesium, potassium and sodium) assessed at baseline and 12 weeks. Dietary intake and urine pH change also were outcome variables. The dietary change was calculated with 3 day diet diaries and a 24 hour recall. Intervention participants kept a twice weekly record of fruit, vegetable and herb intake and urine pH. Discussion This study will provide information on midlife women

  12. 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

  13. Home and health in people ageing with Parkinson’s disease: study protocol for a prospective longitudinal cohort survey study

    PubMed Central

    2013-01-01

    Background With an increased life expectancy for the general population as well as for those ageing with chronic diseases, there are major challenges to the affected individuals and their families, but also to health care and societal planning. Most important, an increasing proportion of older people remain living in their ordinary homes despite health decline and disability. However, little is known about the home and health situation of people ageing with Parkinson’s disease (PD), and older people are often excluded from PD-research. Methods/design The overall aim of the present project is to generate knowledge on home and health dynamics in people with PD, with an explicit attention to PD-specific symptomatology. We will concentrate on aspects of home and health captured by state-of-the-art methodology from gerontology as well as PD-research, health science and rehabilitation. This study protocol describes a longitudinal cohort survey study that includes a baseline data collection and a 3-year follow-up. Both data collection waves include self-administered questionnaires, structured interviews, clinical assessments and observations during home visits effectuated by research staff with project-specific training. In order to arrive at a follow-up sample of N=160, 250 participants identified by PD specialist nurses are being recruited from three hospitals in southern Sweden. With no lower or upper age limit, only those diagnosed with PD since at least one year were included. The exclusion criteria were: difficulties in understanding or speaking Swedish and/or cognitive difficulties/other reasons making the individual unable to give informed consent or to take part in the majority of the data collection. The data collection targets environmental factors such as assistive devices, social support, physical environmental barriers, accessibility problems and perceived aspects of home. A broad variety of instruments tap PD-specific problems (e.g. freezing of gait, fear

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

    PubMed Central

    2012-01-01

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

  15. Improving the Prevention of Cardiovascular Disease in Primary Health Care: The Model for Prevention Study Protocol

    PubMed Central

    Davey, Rachel C; Cochrane, Thomas; Williams, Lauren T; Clancy, Tanya

    2014-01-01

    Background Cardiovascular disease (CVD) is the leading cause of death globally, and accounted for nearly 31% of all deaths in Australia in 2011. The primary health care sector is at the frontline for addressing CVD, however, an evidence-to-practice gap exists in CVD risk assessment and management. General practice plays a key role in CVD risk assessment and management, but this sector cannot provide ongoing lifestyle change support in isolation. Community-based lifestyle modification services and programs provided outside the general practice setting have a key role in supporting and sustaining health behavior change. Fostering linkages between the health sector and community-based lifestyle services, and creating sustainable systems that support these sectors is important. Objective The objective of the study Model for Prevention (MoFoP) is to take a case study approach to examine a CVD risk reduction intervention in primary health care, with the aim of identifying the key elements required for an effective and sustainable approach to coordinate CVD risk reduction across the health and community sectors. These elements will be used to consider a new systems-based model for the prevention of CVD that informs future practice. Methods The MoFoP study will use a mixed methods approach, comprising two complementary research elements: (1) a case study, and (2) a pre/post quasi-experimental design. The case study will consider the organizations and systems involved in a CVD risk reduction intervention as a single case. The pre/post experimental design will be used for HeartLink, the intervention being tested, where a single cohort of patients between 45 and 74 years of age (or between 35 and 74 years of age if Aboriginal or Torres Strait Islander) considered to be at high risk for a CVD event will be recruited through general practice, provided with enhanced usual care and additional health behavior change support. A range of quantitative and qualitative data will be

  16. 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

  17. 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

  18. The childbearing health and related service needs of newcomers (CHARSNN) study protocol

    PubMed Central

    Gagnon, Anita J; Wahoush, Olive; Dougherty, Geoffrey; Saucier, Jean-François; Dennis, Cindy-Lee; Merry, Lisa; Stanger, Elizabeth; Stewart, Donna E

    2006-01-01

    Background Refugee and asylum-seeking women in Canada may have significant harmful childbearing health outcomes and unmet health and social care needs. The most vulnerable of these women are: those who have left their countries by force (e.g., war, rape or abuse histories), are separated from their families, have limited knowledge of the host country languages, and are visible minorities. Asylum-seekers face additional stresses related to their unknown future status and are marginalized with regards to access to provincial health care systems. The prevalence and severity of health issues in this population is not known nor is the extent of response from social service and health care systems (including variation in provincial service delivery). Understanding the magnitude of health and social concerns of newcomers requires data from a representative sample of childbearing refugee and asylum-seeking women resettling in Canada to permit comparisons to be made with non-refugee immigrant and Canadian-born women. Our research questions are: (1) Do refugee or asylum-seeking women and their infants, experience a greater number or a different distribution of harmful health events during pregnancy, at birth, and during the postpartum period than non-refugee immigrant or Canadian-born women? (2) Are the harmful health events experienced postpartum by asylum-seeking women and their infants, addressed less often (compared to refugees, non-refugee immigrants, and Canadian-born women) by the Canadian health care system as delivered in each of the three major receiving cities for newcomers? Methods/design This is a four-year multi-site prospective cohort study (pregnancy to 4 months postpartum). We will seek to recruit 2400 women [200 in each of 4 groups (refugees, asylum-seekers, non-refugee immigrants, and Canadian-born) from 1 of 12 postpartum hospital units across the 3 largest receiving cities for newcomers to Canada – Montreal, Toronto, and Vancouver]. Discussion

  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. [The INHES cohort study on the health status of nurses in Italy: research protocol].

    PubMed

    Calzoni, L; Filippone, A M; Mannocci, A; Germani, T; Menafra, R; Pulimeno, A; Cicolini, G; Manzoli, L; Boccia, A; La Torre, G

    2011-01-01

    Due to the intense emotional involvement and the often problematic working conditions characterizing their profession, Nurses appear to be especially susceptible to the negative effects of a complex set of stressors, with important repercussions to their health. Nevertheless, scientific literature assessing the health status of Nurses in Italy is still scarce. With INHES (Italian Nurses' HEalth Study), we propose to remedy this gap by implementing a cohort study which will start from the analysis of some local healthcare facilities and which may subsequently extend throughout the country. Study participants will be Nurses selected according to the following inclusion criteria: 1) age between 30 and 55 years; 2) having been employed in the current healthfacilityfor the last five years; 3) having performed care duties in wards or in day care services for the last five years. The objectives of this study, which will be carried out through the administration of a validated questionnaire, are the following: to measure the incidence and prevalence rates of a series of diseases in the nursing population, highlighting potential correlations with working activity, job-related stress or environmental and personal risk factors; to assess the quality of life and psychological health of the participants, evaluating the interference of psychophysical disorders with their work and social activities; to investigate the implementation of wellness promotion, prevention, case management and disability management policies by healthcare facilities. The evidence gathered will provide a valid scientific support for the development of more effective policies for protecting Nurses' health, with positive social and economic repercussions for the entire community. PMID:22403993

  2. Touch screen computer health assessment in Australian general practice patients: a cross-sectional study protocol

    PubMed Central

    Carey, Mariko Leanne; Sanson-Fisher, Robert William; Russell, Grant; Mazza, Danielle; Makeham, Meredith; Paul, Christine Louise; Inder, Kerry Jane; D'Este, Catherine

    2012-01-01

    Introduction Cardiovascular disease (CVD) and cancer are leading causes of death globally. Early detection of cancer and risk factors for CVD may improve health outcomes and reduce mortality. General practitioners (GPs) are accessed by the majority of the population and play a key role in the prevention and early detection of chronic disease risk factors. This cross-sectional study aims to assess the acceptability of an electronic method of data collection in general practice patients. The study will describe the proportion screened in line with guidelines for CVD risk factors and cancer as well as report the prevalence of depression, lifestyle risk factors, level of provision of preconception care, cervical cancer vaccination and bone density testing. Lastly, the study will assess the level of agreement between GPs and patients perception regarding presence of risk factors and screening. Methods and analysis The study has been designed to maximise recruitment of GPs by including practitioners in the research team, minimising participation burden on GPs and offering remuneration for participation. Patient recruitment will be carried out by a research assistant located in general practice waiting rooms. Participants will be asked regarding the acceptability of the touch screen computer and to report on a range of health risk and preventive behaviours using the touch screen computer. GPs will complete a one-page survey indicating their perception of the presence of risk behaviours in their patients. Descriptive statistics will be generated to describe the acceptability of the touch screen and prevalence of health risk behaviours. Cohen's κ will be used to assess agreement between GP and patient perception of presence of health risk behaviours. Ethics and dissemination This study has been approved by the human research committees in participating universities. Findings will be disseminated via peer-reviewed publications, conference presentations as well as practice

  3. Same-Day Counseling: Study Protocol for the Evaluation of a New Mental Health Service

    PubMed Central

    Ewen, Victoria; Bailey, Kathleen; Haggarty, John M; Dama, Sumeet; Mushquash, Christopher J

    2016-01-01

    Background Single-session counseling is being implemented across Canada to increase the accessibility and availability of mental health services. Despite increasing use, existing research on single-session counseling is sparse and has methodological limitations. In addition, some stakeholders are skeptical that this model of care can support meaningful change for clients. Objective The aim of this study is to evaluate a new single-session counseling program (called Same-Day Counseling) offered in an outpatient community mental health clinic in Northwestern Ontario, Canada. Methods Clients who attend Same-Day Counseling services will be given the opportunity to participate in the program evaluation. Those who consent will complete measures before their session, after their session, and at 1-month follow-up. Data will provide information on who accesses Same-Day Counseling (eg, typical presenting problems, symptom severity), client satisfaction with services, and whether clients benefit from the services (eg, improved functioning and reduced symptom severity). Results Data collection is underway with 80 participants having completed baseline measures and 55 participants having completed follow-up measures. Data collection is expected to conclude in December 2015. Conclusions This study is designed to contribute to the literature regarding the integration of single-session counseling into ongoing mental health services, with additional attention to methodological rigour. Our approach will help to address ongoing concerns regarding the implementation of single-session counseling, and inform health care providers and policy makers regarding the utility of this model for addressing the mental health care need of the community. PMID:26842891

  4. Putting health status guided COPD management to the test: protocol of the MARCH study

    PubMed Central

    2013-01-01

    Background Chronic Obstructive Pulmonary Disease (COPD) is a disease state characterized by airflow limitation that is not fully reversible and usually progressive. Current guidelines, among which the Dutch, have so far based their management strategy mainly on lung function impairment as measured by FEV1, while it is well known that FEV1 has a poor correlation with almost all features of COPD that matter to patients. Based on this discrepancy the GOLD 2011 update included symptoms and impact in their treatment algorithm proposal. Health status measures capture both symptoms and impact and could therefore be used as a standardized way to capture the information a doctor could otherwise only collect by careful history taking and recording. We hypothesize that a treatment algorithm that is based on a simple validated 10 item health status questionnaire, the Clinical COPD Questionnaire (CCQ), improves health status (as measured by SGRQ) and classical COPD outcomes like exacerbation frequency, patient satisfaction and health care utilization compared to usual care based on guidelines. Methods/Design This hypothesis will be tested in a randomized controlled trial (RCT) following 330 patients for two years. During this period general practitioners will receive treatment advices every four months that are based on the patient’s health status (in half of the patients, intervention group) or on lung function (the remaining half of the patients, usual care group). Discussion During the design process, the selection of outcomes and the development of the treatment algorithm were challenging. This is discussed in detail in the manuscript to facilitate researchers in designing future studies in this changing field of implementation research. Trial registration Netherlands Trial Register, NTR2643 PMID:23826685

  5. Policy to implementation: evidence-based practice in community mental healthstudy protocol

    PubMed Central

    2013-01-01

    Background Evidence-based treatments (EBTs) are not widely available in community mental health settings. In response to the call for implementation of evidence-based treatments in the United States, states and counties have mandated behavioral health reform through policies and other initiatives. Evaluations of the impact of these policies on implementation are rare. A systems transformation about to occur in Philadelphia, Pennsylvania, offers an important opportunity to prospectively study implementation in response to a policy mandate. Methods/design Using a prospective sequential mixed-methods design, with observations at multiple points in time, we will investigate the responses of staff from 30 community mental health clinics to a policy from the Department of Behavioral Health encouraging and incentivizing providers to implement evidence-based treatments to treat youth with mental health problems. Study participants will be 30 executive directors, 30 clinical directors, and 240 therapists. Data will be collected prior to the policy implementation, and then at two and four years following policy implementation. Quantitative data will include measures of intervention implementation and potential moderators of implementation (i.e., organizational- and leader-level variables) and will be collected from executive directors, clinical directors, and therapists. Measures include self-reported therapist fidelity to evidence-based treatment techniques as measured by the Therapist Procedures Checklist-Revised, organizational variables as measured by the Organizational Social Context Measurement System and the Implementation Climate Assessment, leader variables as measured by the Multifactor Leadership Questionnaire, attitudes towards EBTs as measured by the Evidence-Based Practice Attitude Scale, and knowledge of EBTs as measured by the Knowledge of Evidence- Based Services Questionnaire. Qualitative data will include semi-structured interviews with a subset of the

  6. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol

    PubMed Central

    2012-01-01

    Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year [1], coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious

  7. 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

  8. 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

  9. 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

  10. 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

  11. Processes and Outcomes of the Veterans Health Administration Safe Patient Handling Program: Study Protocol

    PubMed Central

    Toyinbo, Peter; Patel, Nitin; Powell-Cope, Gail; Hahm, Bridget; Elnitsky, Christine; Besterman-Dahan, Karen; Campbell, Robert; Sutton, Bryce

    2013-01-01

    Background Health care workers, such as nurses, nursing aides, orderlies, and attendants, who manually move patients, are consistently listed in the top professions for musculoskeletal injuries (MSIs) by the Bureau of Labor Statistics. These MSIs are typically caused by high-risk patient caregiving activities. In 2008, a safe patient handling (SPH) program was implemented in all 153 Veterans Administration Medical Centers (VAMCs) throughout the United States to reduce patient handling injuries. Objective The goal of the present study is to evaluate the effects associated with the national implementation of a comprehensive SPH program. The primary objectives of the research were to determine the effectiveness of the SPH program in improving direct care nursing outcomes and to provide a context for understanding variations in program results across sites over time. Secondary objectives of the present research were to evaluate the effectiveness of the program in reducing direct and indirect costs associated with patient handling, to explore the potential mediating and moderating mechanisms, and to identify unintended consequences of implementing the program. Methods This 3-year longitudinal study used mixed methods of data collection at 6- to 9-month intervals. The analyses will include data from surveys, administrative databases, individual and focus group interviews, and nonparticipant observations. For this study, a 3-tiered measurement plan was used. For Tier 1, the unit of analysis was the facility, the data source was the facility coordinator or administrative data, and all 153 VAMCs participated. For Tier 2, frontline caregivers and program peer leaders at 17 facilities each completed different surveys. For Tier 3, six facilities completed qualitative site visits, which included individual interviews, focus groups, and nonparticipant observations. Multiple regression models were proposed to test the effects of SPH components on nursing outcomes related to

  12. Making sense of health information technology implementation: A qualitative study protocol

    PubMed Central

    2010-01-01

    Background Implementing new practices, such as health information technology (HIT), is often difficult due to the disruption of the highly coordinated, interdependent processes (e.g., information exchange, communication, relationships) of providing care in hospitals. Thus, HIT implementation may occur slowly as staff members observe and make sense of unexpected disruptions in care. As a critical organizational function, sensemaking, defined as the social process of searching for answers and meaning which drive action, leads to unified understanding, learning, and effective problem solving -- strategies that studies have linked to successful change. Project teamwork is a change strategy increasingly used by hospitals that facilitates sensemaking by providing a formal mechanism for team members to share ideas, construct the meaning of events, and take next actions. Methods In this longitudinal case study, we aim to examine project teams' sensemaking and action as the team prepares to implement new information technology in a tiertiary care hospital. Based on management and healthcare literature on HIT implementation and project teamwork, we chose sensemaking as an alternative to traditional models for understanding organizational change and teamwork. Our methods choices are derived from this conceptual framework. Data on project team interactions will be prospectively collected through direct observation and organizational document review. Through qualitative methods, we will identify sensemaking patterns and explore variation in sensemaking across teams. Participant demographics will be used to explore variation in sensemaking patterns. Discussion Outcomes of this research will be new knowledge about sensemaking patterns of project teams, such as: the antecedents and consequences of the ongoing, evolutionary, social process of implementing HIT; the internal and external factors that influence the project team, including team composition, team member interaction, and

  13. A theory-based online health behavior intervention for new university students: study protocol

    PubMed Central

    2013-01-01

    Background Too few young people engage in behaviors that reduce the risk of morbidity and premature mortality, such as eating healthily, being physically active, drinking sensibly and not smoking. The present research developed an online intervention to target these health behaviors during the significant life transition from school to university when health beliefs and behaviors may be more open to change. This paper describes the intervention and the proposed approach to its evaluation. Methods/design Potential participants (all undergraduates about to enter the University of Sheffield) will be emailed an online questionnaire two weeks before starting university. On completion of the questionnaire, respondents will be randomly assigned to receive either an online health behavior intervention (U@Uni) or a control condition. The intervention employs three behavior change techniques (self-affirmation, theory-based messages, and implementation intentions) to target four heath behaviors (alcohol consumption, physical activity, fruit and vegetable intake, and smoking). Subsequently, all participants will be emailed follow-up questionnaires approximately one and six months after starting university. The questionnaires will assess the four targeted behaviors and associated cognitions (e.g., intentions, self-efficacy) as well as socio-demographic variables, health status, Body Mass Index (BMI), health service use and recreational drug use. A sub-sample of participants will provide a sample of hair to assess changes in biochemical markers of health behavior. A health economic evaluation of the cost effectiveness of the intervention will also be conducted. Discussion The findings will provide evidence on the effectiveness of online interventions as well as the potential for intervening during significant life transitions, such as the move from school to university. If successful, the intervention could be employed at other universities to promote healthy behaviors among new

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. Study protocol for the World Health Organization project to develop a Quality of Life assessment instrument (WHOQOL).

    PubMed

    1993-04-01

    The World Health Organization (WHO) has undertaken a project to develop an instrument (the WHOQOL) for measuring quality of life. Quality of life is defined as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by the person's physical health, psychological state, level of independence, social relationships, and their relationship to salient features of their environment. The instrument will be developed in the framework of a collaborative project involving numerous centres in different cultural settings. In addition, it will have proven psychometric properties of validity, responsiveness and reliability and will be sensitive to the cultural setting in which it is applied, whilst maintaining comparability of scores across different cultural settings. This paper outlines the characteristics of the planned instrument and the study protocol governing work on its development. To date steps 1 through 5 have been completed and work is progressing on step 6. It is anticipated that the instrument will be available for piloting in July 1993 and a final version available for use in June 1994. PMID:8518769

  20. 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

  1. Social networks of health care providers and patients in cardiovascular risk management: a study protocol

    PubMed Central

    2014-01-01

    Background In recent years, preventive and clinical interventions for cardiovascular risk management have been implemented widely in primary care in the Netherlands. Although this has enhanced quality and outcomes of cardiovascular risk management, further improvement remains possible. In the planned observational study, we aim to examine the role of social networks of healthcare providers and patients in quality and outcomes of cardiovascular risk management. Methods/Design In a longitudinal observational study, data on social networks of approximately 300 primary care providers from 30 general practices and 900 cardiovascular patients will be collected twice, with a six month interval, using a mix of measures. Social networks are documented with specifically designed questionnaires for patients, relatives, and healthcare professionals. For each included patient, we will extract from medical records to gather data on clinical processes and cardiovascular risk predictors. Data on self-management and psychosocial outcomes of patients will be collected using questionnaires for patients. The analysis focuses on identifying network characteristics, which are associated with (changes in) cardiovascular risk management or self-management. Discussion This research will provide insight into the role of social networks of patients and providers in cardiovascular risk management in primary practice. Trial registration Nederlands Trial Register NTR4069. PMID:24942555

  2. 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

  3. 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

  4. Evaluation of Vitamin D Standardization Program protocols for standardizing serum 25-hydroxyvitamin D data: a case study of the program's potential for national nutrition and health surveys12345

    PubMed Central

    Cashman, Kevin D; Kiely, Mairead; Kinsella, Michael; Durazo-Arvizu, Ramón A; Tian, Lu; Zhang, Yue; Lucey, Alice; Flynn, Albert; Gibney, Michael J; Vesper, Hubert W; Phinney, Karen W; Coates, Paul M; Picciano, Mary F; Sempos, Christopher T

    2013-01-01

    Background: The Vitamin D Standardization Program (VDSP) has developed protocols for standardizing procedures of 25-hydroxyvitamin D [25(OH)D] measurement in National Health/Nutrition Surveys to promote 25(OH)D measurements that are accurate and comparable over time, location, and laboratory procedure to improve public health practice. Objective: We applied VDSP protocols to existing ELISA-derived serum 25(OH)D data from the Irish National Adult Nutrition Survey (NANS) as a case-study survey and evaluated their effectiveness by comparison of the protocol-projected estimates with those from a reanalysis of survey serums by using liquid chromatography–tandem mass spectrometry (LC–tandem MS). Design: The VDSP reference system and protocols were applied to ELISA-based serum 25(OH)D data from the representative NANS sample (n = 1118). A reanalysis of 99 stored serums by using standardized LC–tandem MS and resulting regression equations yielded predicted standardized serum 25(OH)D values, which were then compared with LC–tandem MS reanalyzed values for all serums. Results: Year-round prevalence rates for serum 25(OH)D concentrations <30, <40, and <50 nmol/L were 6.5%, 21.9%, and 40.0%, respectively, via original ELISA measurements and 11.4%, 25.3%, and 43.7%, respectively, when VDSP protocols were applied. Differences in estimates at <30- and <40-nmol/L thresholds, but not at the <50-nmol/L threshold, were significant (P < 0.05). A reanalysis of all serums by using LC–tandem MS confirmed prevalence estimates as 11.2%, 27.2%, and 45.0%, respectively. Prevalences of serum 25(OH)D concentrations >125 nmol/L were 1.2%, 0.3%, and 0.6% by means of ELISA, VDSP protocols, and LC–tandem MS, respectively. Conclusion: VDSP protocols hold a major potential for national nutrition and health surveys in terms of the standardization of serum 25(OH)D data. PMID:23615829

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Monitoring air pollution effects on children for supporting public health policy: the protocol of the prospective cohort MAPEC study

    PubMed Central

    Feretti, D; Ceretti, E; De Donno, A; Moretti, M; Carducci, A; Bonetta, S; Marrese, M R; Bonetti, A; Covolo, L; Bagordo, F; Villarini, M; Verani, M; Schilirò, T; Limina, R M; Grassi, T; Monarca, S; Casini, B; Carraro, E; Zani, C; Mazzoleni, G; Levaggi, R; Gelatti, U

    2014-01-01

    Introduction Genotoxic biomarkers have been studied largely in adult population, but few studies so far have investigated them in children exposed to air pollution. Children are a high-risk group as regards the health effects of air pollution and some studies suggest that early exposure during childhood can play an important role in the development of chronic diseases in adulthood. The objective of the project is to evaluate the associations between the concentration of urban air pollutants and biomarkers of early biological effect in children, and to propose a model for estimating the global risk of early biological effects due to air pollutants and other factors in children. Methods and analysis Two biomarkers of early biological effects, DNA damage by the comet assay and the micronuclei (MN) test, will be investigated in oral mucosa cells of 6–8-year-old children. Concurrently, some toxic airborne pollutants (polycyclic aromatic hydrocarbon (PAH) and nitro-PAH) and in vitro air mutagenicity and toxicity in ultra-fine air particulates (PM0.5) will be evaluated. Furthermore, demographic and socioeconomic variables, other sources of exposures to air pollutants and lifestyle variables will be assessed by a structured questionnaire. The associations between sociodemographic, environmental and other exposure variables and biomarkers of early biological effect using univariate and multivariate models will be analysed. A tentative model for calculating the global absolute risk of having early biological effects caused by air pollution and other variables will be proposed. Ethics and dissemination The project has been approved by the Ethics Committees of the local Health Authorities. The results will be communicated to local Public Health Agencies, for supporting educational programmes and health policy strategies. LIFE+2012 Environment Policy and Governance. LIFE12 ENV/IT/000614. PMID:25227631

  11. Improving Well-being and Health for People with Dementia (WHELD): study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background People with dementia living in care homes often have complex mental health problems, disabilities and social needs. Providing more comprehensive training for staff working in care home environments is a high national priority. It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments. Well-being and Health for People with Dementia (WHELD) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention. This optimised intervention is based on a factorial study and qualitative evaluation, to combine: training on person-centred care, promoting person-centred activities and interactions, and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes. Design The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom. Discussion The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes. This study will be the largest and best powered randomised controlled trial (RCT) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide. Trial registration Current controlled trials ISRCTN62237498 Date registered: 5 September 2013 PMID:25016303

  12. 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

  13. 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

  14. 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

  15. A Community-based Oral Health Promotion Model for HIV Patients in Nairobi, East District in Kenya: a Study Protocol

    PubMed Central

    Koyio, Lucina N.; van der Sanden, Wil J.M.; van der Ven, Andre; Mulder, Jan; Creugers, Nico H.J.; Merkx, Matthias A.W.; Frencken, Jo E.

    2013-01-01

    General HIV-related orofacial lesions, most commonly oropharyngeal candidiasis, have a typical clinical appearance and can be recognised by members of the community. Although affected patients often experience pain leading to compromised eating and swallowing, barriers such as social stigma and lack of knowledge regarding available services may prevent them from seeking early care. Educating the community about these lesions through community health workers (CHWs) who are democratically elected community members may encourage individuals affected to seek early oral healthcare in the health facilities. A health facility (HF) is a health centre mainly run by clinical officers (CO), i.e. personnel with a 3-year medical training, and nurses. This study aims to evaluate the effect of a CHW training programme on: i) their knowledge and recognition of HIV-related oral-facial lesions at a community level; and ii) referral of affected patients from the community to the HFs. Design and Methods All 800 CHWs in 2 administrative divisions of Nairobi East District (test group n=400; control group n=400) will be selected. The test group will receive training. CHWs in both groups will be assessed at 4 time points: −3, 0, +3 and +6 months with reference to the training on: i) their knowledge of HIV-related orofacial lesions (using a written questionnaire); and ii) their performance in referring affected patients to the HFs (using clinical data). Expected Impact Early recognition of HIV-related orofacial lesions at a community level will prompt community members to seek early oral care, leading to early HIV testing and counselling regarding failure of antiretroviral therapy, while treatment outcomes are still favourable. PMID:25170476

  16. The effect of walking on falls in older people: the 'Easy Steps to Health' randomized controlled trial study protocol

    PubMed Central

    2011-01-01

    Background Falls in older people continue to be a major public health issue in industrialized countries. Extensive research into falls prevention has identified exercise as a proven fall prevention strategy. However, despite over a decade of promoting physical activity, hospitalisation rates due to falls injuries in older people are still increasing. This could be because efforts to increase physical activity amongst older people have been unsuccessful, or the physical activity that older people engage in is insufficient and/or inappropriate. The majority of older people choose walking as their predominant form of exercise. While walking has been shown to lower the risk of many chronic diseases its role in falls prevention remains unclear. This paper outlines the methodology of a study whose aims are to determine: if a home-based walking intervention will reduce the falls rate among healthy but inactive community-dwelling older adults (65 + years) compared to no intervention (usual activity) and; whether such an intervention can improve risk factors for falls, such as balance, strength and reaction time. Methods/Design This study uses a randomised controlled trial design. A total of 484 older people exercising less than 120 minutes per week will be recruited through the community and health care referrals throughout Sydney and neighboring regions. All participants are randomised into either the self-managed walking program group or the health-education waiting list group using a block randomization scheme. Outcome measures include prospective falls and falls injuries, quality of life, and physical activity levels. A subset of participants (n = 194) will also receive physical performance assessments comprising of tests of dynamic balance, strength, reaction time and lower limb functional status. Discussion Certain types of physical activity can reduce the risk of falls. As walking is already the most popular physical activity amongst older people, if walking is

  17. 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

  18. 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

  19. Geriatric study in Europe on health effects of air quality in nursing homes (GERIE study) profile: objectives, study protocol and descriptive data

    PubMed Central

    2013-01-01

    Background Indoor air pollution (IAP) constitutes a major global public health problem requiring increasing efforts in research and policymaking that may have special significance for elderly that are likely to spend most of their day indoors and appear to be particularly susceptible to adverse effects of chemical pollutants and bio-contaminants. Yet, evidence existing on the effects of IAP in elderly is scanty. The Geriatric study in Europe on health effects of air quality in nursing homes (GERIE) study aimed to assess health effects of major indoor air pollutants and thermal conditions in elderly (> 70 years) living stably in nursing homes (NH) across Europe. Respiratory effects were particularly considered as airways and lung constitute the first target of air pollutants. Objectives We describe here the rationale and the methods of the GERIE Study. Methods 8 nursing homes were randomly selected in 7 European countries. Twenty individuals were randomly selected in each nursing home. Major indoor and outdoor air chemical pollutants (PM10, PM2.5, PM0.1, formaldehyde, NO2; O3, VOC, CO2) and bio-contaminants (moulds, allergens) were assessed objectively with standardized procedures. Major health status indicators were assessed through a standardized questionnaire, non-invasive clinical tests and blood and urine biomarkers as well as saliva for ADN. Results The GERIE study has given the opportunity to publish two reviews on respiratory health effects of indoor and outdoor air pollution in elderly. In addition it has provided the inventory of air quality and thermal conditions in 50 nursing homes across Europe and data on respiratory health status in 600 elderly aged 82 years in mean. Major future results will include the relationships between NH environment and health in elderly. Conclusions The main long-term purpose of the GERIE study is to improve the health of elderly who permanently reside in nursing homes or of those who are exposed to indoor air pollution

  20. A study of MAC protocols for WBANs.

    PubMed

    Ullah, Sana; Shen, Bin; Islam, S M Riazul; Khan, Pervez; Saleem, Shahnaz; Kwak, Kyung Sup

    2010-01-01

    The seamless integration of low-power, miniaturised, invasive/non-invasive lightweight sensor nodes have contributed to the development of a proactive and unobtrusive Wireless Body Area Network (WBAN). A WBAN provides long-term health monitoring of a patient without any constraint on his/her normal dailylife activities. This monitoring requires the low-power operation of invasive/non-invasive sensor nodes. In other words, a power-efficient Medium Access Control (MAC) protocol is required to satisfy the stringent WBAN requirements, including low-power consumption. In this paper, we first outline the WBAN requirements that are important for the design of a low-power MAC protocol. Then we study low-power MAC protocols proposed/investigated for a WBAN with emphasis on their strengths and weaknesses. We also review different power-efficient mechanisms for a WBAN. In addition, useful suggestions are given to help the MAC designers to develop a low-power MAC protocol that will satisfy the stringent requirements. PMID:22315531

  1. 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

  2. A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France

    PubMed Central

    2012-01-01

    Background Several studies suggest that the number of risk factors rather than their nature is key to mental health disorders in childhood. Method and design The objective of this multicentre randomized controlled parallel trial (PROBE methodology) is to assess the impact in a multi-risk French urban sample of a home-visiting program targeting child mental health and its major determinants. This paper describes the protocol of this study. In the study, pregnant women were eligible if they were: living in the intervention area; able to speak French, less than 26 years old; having their first child; less than 27 weeks of amenorrhea; and if at least one of the following criteria were true: less than twelve years of education, intending to bring up their child without the presence of the child’s father, and 3) low income. Participants were randomized into either the intervention or the control group. All had access to usual care in mother-child centres and community mental health services free of charge in every neighbourhood. Psychologists conducted all home visits, which were planned on a weekly basis from the 7th month of pregnancy and progressively decreasing in frequency until the child’s second birthday. Principle outcome measures included child mental health at 24 months and two major mediating variables for infant mental health: postnatal maternal depression and the quality of the caring environment. A total of 440 families were recruited, of which a subsample of 120 families received specific attachment and caregiver behaviour assessment. Assessment was conducted by an independent assessment team during home visits and, for the attachment study, in a specifically created Attachment Assessment laboratory. Discussion The CAPEDP study is the first large-scale randomised, controlled infant mental health promotion programme to take place in France. A major specificity of the program was that all home visits were conducted by specifically trained

  3. Protocol for investigating genetic determinants of posttraumatic stress disorder in women from the Nurses' Health Study II

    PubMed Central

    Koenen, Karestan C; DeVivo, Immaculata; Rich-Edwards, Janet; Smoller, Jordan W; Wright, Rosalind J; Purcell, Shaun M

    2009-01-01

    Background One in nine American women will meet criteria for the diagnosis of posttraumatic stress disorder (PTSD) in their lifetime. Although twin studies suggest genetic influences account for substantial variance in PTSD risk, little progress has been made in identifying variants in specific genes that influence liability to this common, debilitating disorder. Methods and design We are using the unique resource of the Nurses Health Study II, a prospective epidemiologic cohort of 68,518 women, to conduct what promises to be the largest candidate gene association study of PTSD to date. The entire cohort will be screened for trauma exposure and PTSD; 3,000 women will be selected for PTSD diagnostic interviews based on the screening data. Our nested case-control study will genotype1000 women who developed PTSD following a history of trauma exposure; 1000 controls will be selected from women who experienced similar traumas but did not develop PTSD. The primary aim of this study is to detect genetic variants that predict the development of PTSD following trauma. We posit inherited vulnerability to PTSD is mediated by genetic variation in three specific neurobiological systems whose alterations are implicated in PTSD etiology: the hypothalamic-pituitary-adrenal axis, the locus coeruleus/noradrenergic system, and the limbic-frontal neuro-circuitry of fear. The secondary, exploratory aim of this study is to dissect genetic influences on PTSD in the broader genetic and environmental context for the candidate genes that show significant association with PTSD in detection analyses. This will involve: conducting conditional tests to identify the causal genetic variant among multiple correlated signals; testing whether the effect of PTSD genetic risk variants is moderated by age of first trauma, trauma type, and trauma severity; and exploring gene-gene interactions using a novel gene-based statistical approach. Discussion Identification of liability genes for PTSD would

  4. 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

  5. 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

  6. Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment. PMID:21988774

  7. A service-level action research intervention to improve identification and treatment of cannabis and related mental health issues in young Indigenous Australians: a study protocol

    PubMed Central

    Bohanna, India; Bird, Katrina; Copeland, Jan; Roberts, Nicholas; Clough, Alan

    2014-01-01

    Introduction Regular cannabis use is associated with negative mental health impacts including psychosis, depression and anxiety. Rates of cannabis use have increased in Aboriginal and Torres Strait Islander communities in northern Australia within the last two decades, presenting a significant increased risk to young people's mental health in these regions. Improved screening, early detection and treatment for cannabis-related mental health issues are urgently required. This paper describes a service-level action research intervention and evaluation protocol for use in the few services where it is possible to engage young Aboriginal and Torres Strait Islander Australians. Methods/Design The protocol is being developed in two services where youth mental health is core business: a primary healthcare centre and a youth service in the Cairns and hinterland region, far north Queensland. The protocol calls first for baseline data to be collected using staff and client surveys; network mapping; and analysis of screening, treatment and referral rates. The protocol's intervention phase is driven by service needs identified from baseline data. Intervention strategies focus on implementing/enhancing cannabis screening instruments and processes in line with current best practice; enhancing networks with external drug and mental health services; developing culturally acceptable training and resources; developing activities aiming to reduce cannabis use in young Aboriginal and Torres Strait Islander clients using the services. The protocol requires implementation of the multilevel intervention within each service for 1 year, with follow-up data then collected and compared to baseline. Process evaluation identifies the more effective intervention strategies and documents the challenges to be overcome for full implementation. Ethics and dissemination Ethics approval was provided by The James Cook University, Human Research Ethics Committee. Ethics Approval Number H5322. Peer

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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. PMID:24447970

  13. 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

  14. 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

  15. Effectiveness of an intervention in groups of family caregivers of dependent patients for their application in primary health centers. Study protocol

    PubMed Central

    2010-01-01

    Background Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of sanitary problems in adults with chronic diseases, they usually have a lack of experience in development of psychotherapeutic interventions. However, these interventions are the ones that achieve better results to reduce symptomatology and improve emotional state of caregivers. The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health and Quality of life of caregivers. This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres. Methods/Design This is multicentre clinical trials study, randomized in two parallel groups, carry out in two PHC, Study population: 150 caregivers will be included by consecutive sampling and they will be randomized the half to experimental group and the other half to control group. They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers. Measurements: Each caregiver will be evaluated on a personal interview. The caregivers' assessment protocol: 1) Assessment of different socio-demographic related to care, and caregiver's personal situation. 2)Care-dependent individuals will also be assessed by Barthel Index and Pfeiffer Questionnaire (SPMSQ). 3)Change in caregivers will be the principal measure: family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz & Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring. 4) Intervention implementation measures will also be assessed. Intervention: A psychotherapeutic intervention will be 8 sessions of 90 minutes in groups. This intervention has been initially developed for family caregivers of patients with dementia. Discussion

  16. 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

  17. Universal protocol for alopecia areata clinical studies.

    PubMed

    Mesinkovska, Natasha A; Bergfeld, Wilma F

    2013-12-01

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

  18. [Evaluation of eight Clinical Protocols and Therapeutic Guidelines under the Brazilian Ministry of Health using the AGREE II instrument: a pilot study].

    PubMed

    Ronsoni, Ricardo De March; Pereira, Claudia Cristina de Aguiar; Stein, Airton Tetelbom; Osanai, Mário Henrique; Machado, Carla Jorge

    2015-06-01

    The number of clinical guidelines is increasing worldwide, while there are concerns regarding their quality. In 2000, the Brazilian Ministry of Health began its process of creating clinical guidelines, called Clinical Protocols and Therapeutic Guidelines (PCDT). The goal of this study was to assess the quality of Brazilian guidelines approved since 2009 using the AGREE II instrument (Appraisal of Guidelines for Research and Evaluation). We identified 59 PCDT from 2009 to 2012, of which eight were randomly selected and evaluated by three independent evaluators. For the item "recommends the guidelines", two evaluators recommended the use of all eight, but with modifications, and one did not recommend any to the guidelines. Regarding the item "global quality of the guidelines" (varying from 1 to 7), the mean was 4.25 (SD = 0.46). The results showed the need for adjustments in the PCDT in relation to AGREE II domains. However, due to the instrument's limitations, further studies are needed, including the quality of evidence used in the PCDT. PMID:26200364

  19. Gestational Age Assessment in the Ghana Randomized Air Pollution and Health Study (GRAPHS): Ultrasound Capacity Building, Fetal Biometry Protocol Development, and Ongoing Quality Control

    PubMed Central

    Boamah, Ellen A; Asante, KP; Ae-Ngibise, KA; Kinney, Patrick L; Jack, Darby W; Manu, Grace; Azindow, Irene T; Owusu-Agyei, Seth

    2014-01-01

    Background Four million premature deaths occur yearly as a result of smoke from cooking fires. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is underway in the Kintampo North municipality and South district of rural Ghana to evaluate the impact of improved cook stoves introduced during pregnancy on birth weight and childhood pneumonia. These hypotheses are being tested in a cluster-randomized intervention trial among 1415 maternal-infant pairs within 35 communities assigned to a control arm (traditional cooking) or one of two intervention arms (cooking with an improved biomass stove; cooking with liquefied petroleum gas stoves). Objective The trial is designed to ensure delivery of the stove intervention prior to the period of maximal fetal growth. To answer questions about the impact of household air pollution on pregnancy outcome, accurate gestational age assessment is critical. This manuscript describes in detail the development of the gestational dating protocol, intensive ultrasound training involved, ultrasound capacity building, and ultrasound quality control program. Methods Ultrasound training occurred in several phases over the course of 2 years. Training included a basic obstetric ultrasound course offered to all midwives performing antenatal care at the two study hospitals, followed by a more intense period of hands-on training focused on fetal biometry for a select group of providers demonstrating aptitude in the basic course. A standard operating procedure was developed describing how to obtain all fetal biometric measurements. Consensus was obtained on how biometric images are used in the trial to establish gestational age and estimate the delivery date. An ongoing ultrasound quality control program including the use of an image scorecard was also designed. Results Publication of trial results is anticipated in late 2016. Conclusions Use of ultrasound should be strongly considered in field-based trials involving pregnant women to

  20. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Does a fall prevention educational programme improve knowledge and change exercise prescribing behaviour in health and exercise professionals? A study protocol for a randomised controlled trial

    PubMed Central

    Tiedemann, A; Sturnieks, D L; Hill, A-M; Lovitt, L; Clemson, L; Lord, S R; Harvey, L; Sherrington, C

    2014-01-01

    Introduction Falling in older age is a serious and costly problem. At least one in three older people fall annually. Although exercise is recognised as an effective fall prevention intervention, low numbers of older people engage in suitable programmes. Health and exercise professionals play a crucial role in addressing fall risk in older adults. This trial aims to evaluate the effect of participation in a fall prevention educational programme, compared with a wait-list control group, on health and exercise professionals’ knowledge about fall prevention and the effect on fall prevention exercise prescription behaviour and confidence to prescribe the exercises to older people. Methods and analysis A randomised controlled trial involving 220 consenting health and exercise professionals will be conducted. Participants will be individually randomised to an intervention group (n=110) to receive an educational workshop plus access to internet-based support resources, or a wait-list control group (n=110). The two primary outcomes, measured 3 months after randomisation, are: (1) knowledge about fall prevention and (2) self-perceived change in fall prevention exercise prescription behaviour. Secondary outcomes include: (1) participants’ confidence to prescribe fall prevention exercises; (2) the proportion of people aged 60+ years seen by trial participants in the past month who were prescribed fall prevention exercise; and (3) the proportion of fall prevention exercises prescribed by participants to older people in the past month that comply with evidence-based guidelines. Outcomes will be measured with a self-report questionnaire designed specifically for the trial. Ethics and dissemination The trial protocol was approved by the Human Research Ethics Committee, The University of Sydney, Australia. Trial results will be disseminated via peer reviewed journals, presentations at international conferences and participants’ newsletters. Trial registration number Trial

  7. 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

  8. The Uganda Newborn Study (UNEST): an effectiveness study on improving newborn health and survival in rural Uganda through a community-based intervention linked to health facilities - study protocol for a cluster randomized controlled trial

    PubMed Central

    2012-01-01

    Background Reducing neonatal-related deaths is one of the major bottlenecks to achieving Millennium Development Goal 4. Studies in Asia and South America have shown that neonatal mortality can be reduced through community-based interventions, but these have not been adapted to scalable intervention packages for sub-Saharan Africa where the culture, health system and policy environment is different. In Uganda, health outcomes are poor for both mothers and newborn babies. Policy opportunities for neonatal health include the new national Health Sector Strategic Plan, which now prioritizes newborn health including use of a community model through Village Health Teams (VHT). The aim of the present study is to adapt, develop and cost an integrated maternal-newborn care package that links community and facility care, and to evaluate its effect on maternal and neonatal practices in order to inform policy and scale-up in Uganda. Methods/Design Through formative research around evidence-based practices, and dialogue with policy and technical advisers, we constructed a home-based neonatal care package implemented by the responsible VHT member, effectively a Community Health Worker (CHW). This CHW was trained to identify pregnant women and make five home visits - two before and three just after birth - so that linkages will be made to facility care and targeted messages for home-care and care-seeking delivered. The project is improving care in health units to provide standardized care for the mother and the newborn in both intervention and comparison areas. The study is taking place in a new Demographic Surveillance Site in two rural districts, Iganga and Mayuge, in Uganda. It is a two-arm cluster randomized controlled design with 31 intervention and 32 control areas (villages). The comparison parishes receive the standard care already being provided by the district, but to the intervention villages are added a system for CHWs to visit the mother five times in her home during

  9. A multi-site single-blind clinical study to compare the effects of STAIR Narrative Therapy to treatment as usual among women with PTSD in public sector mental health settings: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background This article provides a description of the rationale, design, and methods of a multisite clinical trial which evaluates the potential benefits of an evidence-based psychosocial treatment, STAIR Narrative Therapy, among women with posttraumatic stress disorder (PTSD) related to interpersonal violence who are seeking services in public sector community mental health clinics. This is the first large multisite trial of an evidence-based treatment for PTSD provided in the context of community settings that are dedicated to the treatment of poverty-level patient populations. Methods The study is enrolling 352 participants in a minimum of 4 community clinics. Participants are randomized into either STAIR Narrative Therapy or Treatment As Usual (TAU). Primary outcomes are PTSD, emotion management and interpersonal problems. The study will allow a flexible application of the protocol determined by patient need and preferences. Secondary analyses will assess the relationship of outcomes to different patterns of treatment implementation for different levels of baseline symptom severity. Discussion The article discusses the rationale and study issues related to the use of a flexible delivery of a protocol treatment and of the selection of treatment as it is actually practiced in the community as the comparator. Trial registration Clinicaltrials.gov identifier: NCT01488539. PMID:24886235

  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. The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions. Methods/design This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting. A small-scale randomized controlled trial (RCT) will investigate the implementation of a goal-setting intervention aimed at promoting behavior change in the domains of physical and cognitive activity in the context of a community resource center for over-50s. Healthy older participants attending the center (n = 75) will be randomized to one of three conditions: control (an interview involving a general discussion about the center); goal-setting (an interview involving identification of up to five personal goals in the domains of physical activity, cognitive activity, diet and health, and social engagement); or goal-setting with mentoring (the goal-setting interview followed by bi-monthly telephone mentoring). All participants will be reassessed after 12 months. Primary outcomes are levels of physical and cognitive activity. Secondary outcomes address psychosocial (self-efficacy, mood, quality of life), cognitive (memory and executive function), and physical fitness (functional and metabolic) domains. Cost-effectiveness will also be examined. Discussion This study will provide information about the feasibility of a community-based lifestyle intervention model for over-50s and of the implementation of a goal-setting intervention for behavior change, together with initial evidence about the short-term effects of goal-setting on behavior. Trial Registration Current Controlled Trials ISRCTN30080637 (http://www.controlled-trials.com) PMID:22827885

  12. 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

  13. 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

  14. [Prenatal care protocol: actions and the easy and difficult aspects dealt by Family Health Strategy nurses].

    PubMed

    Rodrigues, Edilene Matos; do Nascimento, Rafaella Gontijo; Araújo, Alisson

    2011-10-01

    The objective of this study was to learn the perception that nurses have about the protocol of their attributions in prenatal care, identifying the health actions they develop, as well as the easy and difficult aspects in using the referred protocol. This qualitative study was developed with Family Health Strategy nurses in Divinópolis, Minas Gerais. The data survey was performed through interviews with five nurses. The data was submitted to thematic content analysis. Results showed the need for investments in professional qualification for women's health care in the pregnancy-postpartum cycle, as well as to create and implement protocols that promote a better interaction between the medical and nursing work. PMID:22031361

  15. 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

  16. The effectiveness of an abuse assessment protocol in public health prenatal clinics.

    PubMed Central

    Wiist, W H; McFarlane, J

    1999-01-01

    OBJECTIVES: This study evaluated whether incorporation of an abuse assessment protocol into the routine procedures of the prenatal clinics of a large urban public health department led to increased referral for and assessment, identification, and documentation of abuse. METHODS: Evaluation was conducted at 3 matched prenatal clinics serving a total of 12,000 maternity patients per year. Two clinics used the abuse protocol and 1 did not. An audit was performed at the clinics on a randomly selected sample of 540 maternity patient charts for the 15 months before the protocol was initiated and of 540 records for the 15 months after the protocol was introduced. Ninety-six percent of the patients represented in the sample were Latina. RESULTS: At the clinics using the protocol, abuse assessment increased from 0 to 88%. Detection of abuse increased from 0.8% to 7%. There were no changes at the comparison clinic. CONCLUSIONS: Incorporation of an abuse assessment protocol into the routine procedures of public health department prenatal clinics increases the assessment, identification, and documentation of and referral for abuse among pregnant women. An abuse protocol should be a routine part of maternity care. PMID:10432909

  17. 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…

  18. A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare'): Study protocol

    PubMed Central

    2011-01-01

    outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government. Discussion This manuscript presents the protocol for a randomised, multi-centre trial to evaluate the feasibility of a tele-based depression management and CHD secondary prevention program for ACS patients. The results of this trial will provide valuable new information about potential psychological and wellbeing benefits, cost-effectiveness and acceptability of an innovative tele-based depression management and secondary prevention program for CHD patients experiencing depression. Trial Registration Number Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000386235 PMID:21349204

  19. 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

  20. 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

  1. Positive health effects of the natural outdoor environment in typical populations in different regions in Europe (PHENOTYPE): a study programme protocol

    PubMed Central

    Nieuwenhuijsen, Mark J; Kruize, Hanneke; Gidlow, Christopher; Andrusaityte, Sandra; Antó, Josep Maria; Basagaña, Xavier; Cirach, Marta; Dadvand, Payam; Danileviciute, Asta; Donaire-Gonzalez, David; Garcia, Judith; Jerrett, Michael; Jones, Marc; Julvez, Jordi; van Kempen, Elise; van Kamp, Irene; Maas, Jolanda; Seto, Edmund; Smith, Graham; Triguero, Margarita; Wendel-Vos, Wanda; Wright, John; Zufferey, Joris; van den Hazel, Peter Jan; Lawrence, Roderick; Grazuleviciene, Regina

    2014-01-01

    Introduction Growing evidence suggests that close contact with nature brings benefits to human health and well-being, but the proposed mechanisms are still not well understood and the associations with health remain uncertain. The Positive Health Effects of the Natural Outdoor environment in Typical Populations in different regions in Europe (PHENOTYPE) project investigates the interconnections between natural outdoor environments and better human health and well-being. Aims and methods The PHENOTYPE project explores the proposed underlying mechanisms at work (stress reduction/restorative function, physical activity, social interaction, exposure to environmental hazards) and examines the associations with health outcomes for different population groups. It implements conventional and new innovative high-tech methods to characterise the natural environment in terms of quality and quantity. Preventive as well as therapeutic effects of contact with the natural environment are being covered. PHENOTYPE further addresses implications for land-use planning and green space management. The main innovative part of the study is the evaluation of possible short-term and long-term associations of green space and health and the possible underlying mechanisms in four different countries (each with quite a different type of green space and a different use), using the same methodology, in one research programme. This type of holistic approach has not been undertaken before. Furthermore there are technological innovations such as the use of remote sensing and smartphones in the assessment of green space. Conclusions The project will produce a more robust evidence base on links between exposure to natural outdoor environment and human health and well-being, in addition to a better integration of human health needs into land-use planning and green space management in rural as well as urban areas. PMID:24740979

  2. Expanded Quality Management Using Information Power (EQUIP): protocol for a quasi-experimental study to improve maternal and newborn health in Tanzania and Uganda

    PubMed Central

    2014-01-01

    receive quality management and continuous surveys, and comparison districts-only continuous surveys. Discussion EQUIP is a district-scale, proof-of-concept study that evaluates a quality management approach for maternal and newborn health including communities, health facilities, and district health managers, supported by high-quality data from independent continuous household and health facility surveys. The study will generate robust evidence about the effectiveness of quality management and will inform future nationwide implementation approaches for health system strengthening in low-resource settings. Trial registration PACTR201311000681314 PMID:24690284

  3. 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

  4. 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

  5. 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

  6. 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.

  7. Optimising reproductive and child health outcomes by building evidence-based research and practice in South East Asia (SEA-ORCHID): study protocol

    PubMed Central

    Henderson-Smart, David J; Lumbiganon, Pisake; Festin, Mario R; Ho, Jacqueline J; Mohammad, Hakimi; McDonald, Steve J; Green, Sally; Crowther, Caroline A

    2007-01-01

    Background Disorders related to pregnancy and childbirth are a major health issue in South East Asia. They represent one of the biggest health risk differentials between the developed and developing world. Our broad research question is: Can the health of mothers and babies in Thailand, Indonesia, the Philippines and Malaysia be improved by increasing the local capacity for the synthesis of research, implementation of effective interventions, and identification of gaps in knowledge needing further research? Methods/Design The project is a before-after study which planned to benefit from and extend existing regional and international networks. Over five years the project was designed to comprise five phases; pre-study, pre-intervention, intervention, outcome assessment and reporting/dissemination. The study was proposed to be conducted across seven project nodes: four in South East Asia and three in Australia. Each South East Asian study node was planned to be established within an existing department of obstetrics and gynaecology or neonatology and was intended to form the project coordinating centre and focus for evidence-based practice activities within that region. Nine hospitals in South East Asia planned to participate, representing a range of clinical settings. The three project nodes in Australia were intended to provide project support. The intervention was planned to consist of capacity-strengthening activities targeted at three groups: generators of evidence, users of evidence and teachers of evidence. The primary outcome was established as changes in adherence to recommended clinical practices from baseline to completion of the project and impact on health outcomes. Discussion The SEA-ORCHID project was intended to improve care during pregnancy and the perinatal period of mothers and their babies in South East Asia. The possible benefits extend beyond this however, as at the end of this project there is hoped to be an existing network of South East Asian

  8. Innovative interventions to promote positive dental health behaviors and prevent dental caries in preschool children: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dental caries (tooth decay) is highly prevalent and is largely attributable to unhealthy self-care behaviors (diet and oral hygiene). The conventional (health) education (CE), focusing on disseminating information and giving normative advice, often fails to achieve sustained behavioral changes. This study incorporates two innovative elements into CE: (i) motivational interviewing (MI), a client-centered counseling for changing behaviors, and (ii) an interactive caries risk assessment (RA) tool, which is devised to facilitate dental counseling and may enhance MI in several ways. Through a randomized, controlled, evaluator-blinded trial, three intervention schemes (CE, CE + MI, and CE + MI + RA) will be compared for their effectiveness in eliciting dentally healthy behaviors and preventing caries in preschool children. Methods/Design This study targets 3-year-old children who are at a critical stage for embedding health habits. Children with unfavorable dental behaviors (insufficient toothbrushing and/or frequent snacking) and their parents will be recruited from 12 participating kindergartens. Parent-child dyads (n = 690) will be randomly assigned into three groups. In the first group (CE), oral health information and advice will be delivered to parents through pamphlets. In the second group (CE + MI), in addition to the pamphlets, individual MI counseling with each parent will be performed by one of two trained dental hygienists. In the third group (CE + MI + RA), besides pamphlets and MI, interactive RA will be integrated into MI to motivate parents and facilitate their informed decision making and goal planning. At baseline and after 12 and 24 months, parents will complete a questionnaire and children will undergo a dental examination. The effectiveness of the intervention schemes will be compared over 12 and 24 months. The primary outcome will be caries increment in children and proportion of caries-free children. Secondary outcomes will be changes in

  9. 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

  10. 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

  11. Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. Methods The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010. Discussion Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care

  12. 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

  13. Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Extended smoking cessation follow-up after hospital discharge significantly increases abstinence. Hospital smoke-free policies create a period of ‘forced abstinence’ for smokers, thus providing an opportunity to integrate tobacco dependence treatment, and to support post-discharge maintenance of hospital-acquired abstinence. This study is funded by the National Heart, Lung, and Blood Institute (1U01HL1053231). Methods/Design The Inpatient Technology-Supported Assisted Referral study is a multi-center, randomized clinical effectiveness trial being conducted at Kaiser Permanente Northwest (KPNW) and at Oregon Health & Science University (OHSU) hospitals in Portland, Oregon. The study assesses the effectiveness and cost-effectiveness of linking a practical inpatient assisted referral to outpatient cessation services plus interactive voice recognition (AR + IVR) follow-up calls, compared to usual care inpatient counseling (UC). In November 2011, we began recruiting 900 hospital patients age ≥18 years who smoked ≥1 cigarettes in the past 30 days, willing to remain abstinent postdischarge, have a working phone, live within 50 miles of the hospital, speak English, and have no health-related barriers to participation. Each site will randomize 450 patients to AR + IVR or UC using a 2:1 assignment strategy. Participants in the AR + IVR arm will receive a brief inpatient cessation consult plus a referral to available outpatient cessation programs and medications, and four IVR follow-up calls over seven weeks postdischarge. Participants do not have to accept the referral. At KPNW, UC participants will receive brief inpatient counseling and encouragement to self-enroll in available outpatient services. The primary outcome is self-reported thirty-day smoking abstinence at six months postrandomization for AR + IVR participants compared to usual care. Additional outcomes include self-reported and biochemically confirmed seven-day abstinence at

  14. 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

  15. e-SCP-ECG+ Protocol: An Expansion on SCP-ECG Protocol for Health Telemonitoring—Pilot Implementation

    PubMed Central

    Mandellos, George J.; Koukias, Michael N.; Styliadis, Ioannis St.; Lymberopoulos, Dimitrios K.

    2010-01-01

    Standard Communication Protocol for Computer-assisted Electrocardiography (SCP-ECG) provides standardized communication among different ECG devices and medical information systems. This paper extends the use of this protocol in order to be included in health monitoring systems. It introduces new sections into SCP-ECG structure for transferring data for positioning, allergies, and five additional biosignals: noninvasive blood pressure (NiBP), body temperature (Temp), Carbon dioxide (CO2), blood oxygen saturation (SPO2), and pulse rate. It also introduces new tags in existing sections for transferring comprehensive demographic data. The proposed enhanced version is referred to as e-SCP-ECG+ protocol. This paper also considers the pilot implementation of the new protocol as a software component in a Health Telemonitoring System. PMID:20628537

  16. 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

  17. 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

  18. 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

  19. Improving the management of behaviour that challenges associated with dementia in care homes: protocol for pharmacy–health psychology intervention feasibility study

    PubMed Central

    Shaw, Rachel L; Killick, Kirsty; Damery, Sarah; Hilton, Andrea; Wilcock, Jane; Barnes, Nigel; Brown, Graeme; Gillespie, Sarah; Fox, Chris; Barton, Garry; Iliffe, Steve; Seare, Nichola

    2016-01-01

    Introduction The inappropriate use of antipsychotics in people with dementia for behaviour that challenges is associated with an estimated 1800 deaths annually. However, solely focusing on antipsychotics may transfer prescribing to other equally dangerous psychotropics. Little is known about the role of pharmacists in the management of psychotropics used to treat behaviours that challenge. This research aims to determine whether it is feasible to implement and measure the effectiveness of a combined pharmacy–health psychology intervention incorporating a medication review and staff training package to limit the prescription of psychotropics to manage behaviour that challenges in care home residents with dementia. Methods/analysis 6 care homes within the West Midlands will be recruited. People with dementia receiving medication for behaviour that challenges, or their personal consultee, will be approached regarding participation. Medication used to treat behaviour that challenges will be reviewed by the pharmacist, in collaboration with the general practitioner (GP), person with dementia and carer. The behavioural intervention consists of a training package for care home staff and GPs promoting person-centred care and treating behaviours that challenge as an expression of unmet need. The primary outcome measure is the Neuropsychiatric Inventory-Nursing Home version (NPI-NH). Other outcomes include quality of life (EQ-5D and DEMQoL), cognition (sMMSE), health economic (CSRI) and prescribed medication including whether recommendations were implemented. Outcome data will be collected at 6 weeks, and 3 and 6 months. Pretraining and post-training interviews will explore stakeholders’ expectations and experiences of the intervention. Data will be used to estimate the sample size for a definitive study. Ethics/dissemination The project has received a favourable opinion from the East Midlands REC (15/EM/3014). If potential participants lack capacity, a personal

  20. 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

  1. 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.

  2. 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

  3. 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

  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. [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

  6. 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

  7. Inpatient management protocols to reduce health care costs.

    PubMed

    Wachtel, T; Moulton, A W; Pezzullo, J; Hamolsky, M

    1986-01-01

    A group of 12 internists, members of a university-affiliated hospital, designed and implemented protocols for the general inpatient management of four medical problems (chest pain, stroke, pneumonia, and upper gastrointestinal hemorrhage). Hospital charges for the 63 cases were compared with charges generated by 64 controls who had been patients admitted to the same physicians with the same diagnoses during the same period of the preceding year, before the project was begun. A group of nonparticipating internists was similarly evaluated during the two time periods to control for changes in practice patterns extraneous to the intervention. Adjustment was made for inflation (6%) and differences in case mix. The program resulted in a 15% reduction in total average charge generated by the cases. Sizeable reductions were achieved in utilization of EKGs (34.8%), x-rays (15.4%), laboratory testing (20.4%), and drugs (11.4%). Given the prevailing attitude that health care costs are too high and that many services are unnecessary, the benefit of altering physician behavior by using standards established by them for themselves could be substantial, especially with the threat of more restrictive and less sympathetic modes of controlling costs. PMID:3084902

  8. 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

  9. [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

  10. 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

  11. 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

  12. Bath Breakfast Project (BBP) - Examining the role of extended daily fasting in human energy balance and associated health outcomes: Study protocol for a randomised controlled trial [ISRCTN31521726

    PubMed Central

    2011-01-01

    Background Current guidance regarding the role of daily breakfast in human health is largely grounded in cross-sectional observations. However, the causal nature of these relationships has not been fully explored and what limited information is emerging from controlled laboratory-based experiments appears inconsistent with much existing data. Further progress in our understanding therefore requires a direct examination of how daily breakfast impacts human health under free-living conditions. Methods/Design The Bath Breakfast Project (BBP) is a randomised controlled trial comparing the effects of daily breakfast consumption relative to extended fasting on energy balance and human health. Approximately 70 men and women will undergo extensive laboratory-based assessments of their acute metabolic responses under fasted and post-prandial conditions, to include: resting metabolic rate, substrate oxidation, dietary-induced thermogenesis and systemic concentrations of key metabolites/hormones. Physiological and psychological indices of appetite will also be monitored both over the first few hours of the day (i.e. whether fed or fasted) and also following a standardised test lunch used to assess voluntary energy intake under controlled conditions. Baseline measurements of participants' anthropometric characteristics (e.g. DEXA) will be recorded prior to intervention, along with an oral glucose tolerance test and acquisition of adipose tissue samples to determine expression of key genes and estimates of tissue-specific insulin action. Participants will then be randomly assigned either to a group prescribed an energy intake of ≥3000 kJ before 1100 each day or a group to extend their overnight fast by abstaining from ingestion of energy-providing nutrients until 1200 each day, with all laboratory-based measurements followed-up 6 weeks later. Free-living assessments of energy intake (via direct weighed food diaries) and energy expenditure (via combined heart

  13. 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

  14. Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs) to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial

    PubMed Central

    2011-01-01

    Background Around a quarter of the world's neonatal and maternal deaths occur in India. Morbidity and mortality are highest in rural areas and among the poorest wealth quintiles. Few interventions to improve maternal and newborn health outcomes with government-mandated community health workers have been rigorously evaluated at scale in this setting. The study aims to assess the impact of a community mobilisation intervention with women's groups facilitated by ASHAs to improve maternal and newborn health outcomes among rural tribal communities of Jharkhand and Orissa. Methods/design The study is a cluster-randomised controlled trial and will be implemented in five districts, three in Jharkhand and two in Orissa. The unit of randomisation is a rural cluster of approximately 5000 population. We identified villages within rural, tribal areas of five districts, approached them for participation in the study and enrolled them into 30 clusters, with approximately 10 ASHAs per cluster. Within each district, 6 clusters were randomly allocated to receive the community intervention or to the control group, resulting in 15 intervention and 15 control clusters. Randomisation was carried out in the presence of local stakeholders who selected the cluster numbers and allocated them to intervention or control using a pre-generated random number sequence. The intervention is a participatory learning and action cycle where ASHAs support community women's groups through a four-phase process in which they identify and prioritise local maternal and newborn health problems, implement strategies to address these and evaluate the result. The cycle is designed to fit with the ASHAs' mandate to mobilise communities for health and to complement their other tasks, including increasing institutional delivery rates and providing home visits to mothers and newborns. The trial's primary endpoint is neonatal mortality during 24 months of intervention. Additional endpoints include home care

  15. 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

  16. The effects of a regional telepathology project: a study protocol

    PubMed Central

    2012-01-01

    Background Telepathology, which is an emerging form of telemedicine in Canada, is defined as the electronic transmission of pathological images, usually derived from microscopes, from one location to another. There are various applications of telepathology, including case referral for an expert opinion, provision of an emergency service in the absence of a resident pathologist, and education. Until now, there has been relatively little use of telepathology for core diagnostic services in the absence of a local pathologist, but this practice is likely to increase in the future. The Laval University Integrated Health Network is in the process of deploying a telepathology system, primarily to provide an intraoperative frozen section service to small hospitals in sparsely populated areas which are experiencing a severe shortage of on-site pathologists. The telepathology project involves 17 hospitals located in five regions of eastern Quebec, Canada. This paper describes the study protocol that will be used to evaluate the benefits associated with the project. Methods/Design A panel of experts was first assembled by Canada Health Infoway to agree on a set of benefits indicators that could be applied to all telepathology projects across Canada. Using the set of indicators as an input, we have developed a three-step study protocol. First, a survey questionnaire will be distributed to appraise the way pathologists, pathology technologists and surgeons perceive the telepathology system and its impacts. Second, a series of semi-structured interviews will be conducted with project leaders and telepathology users at sites that are representative of all the hospitals in the Laval University Integrated Health Network. The overall aim is to better understand the expected and unexpected effects of telepathology on health care professionals and patients as well as on the regional organization and delivery of care services. Finally, a pre-post design using secondary data is proposed

  17. 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

  18. School-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile (YPSA): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Depression is common and can have devastating effects on the life of adolescents. Psychological interventions are the first-line for treating or preventing depression among adolescents. This proposal aims to evaluate a school-based, universal psychological intervention to reduce depressive symptoms among student's aged 13-14 attending municipal state secondary schools in Santiago, Chile. Study design This is a cluster randomised controlled trial with schools as the main clusters. We compared this intervention with a control group in a study involving 22 schools, 66 classes and approximately 2,600 students. Students in the active schools attended 11 weekly and 3 booster sessions of an intervention based on cognitive-behavioural models. The control schools received their usual but enhanced counselling sessions currently included in their curriculum. Mean depression scores and indicators of levels of functioning were assessed at 3 and 12 months after the completion of the intervention in order to assess the effectiveness of the intervention. Direct and indirect costs were measured in both groups to assess the cost-effectiveness of this intervention. Discussion As far as we are aware this is the first cluster randomised controlled trial of a school intervention for depression among adolescents outside the Western world. Trial Registration ISRCTN19466209 PMID:21333015

  19. 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

  20. 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

  1. The Communities First (ComFi) study: protocol for a prospective controlled quasi-experimental study to evaluate the impact of area-wide regeneration on mental health and social cohesion in deprived communities

    PubMed Central

    White, James; Greene, Giles; Dunstan, Frank; Rodgers, Sarah; Lyons, Ronan A; Humphreys, Ioan; John, Ann; Webster, Chris; Palmer, Stephen; Elliott, Eva; Phillips, Ceri J; Fone, David

    2014-01-01

    Introduction Recent systematic reviews have highlighted the dearth of evidence on the effectiveness of regeneration on health and health inequalities. ‘Communities First’ is an area-wide regeneration scheme to improve the lives of people living in the most deprived areas in Wales (UK). This study will evaluate the impact of Communities First on residents’ mental health and social cohesion. Methods and analysis A prospective controlled quasi-experimental study of the association between residence in Communities First regeneration areas in Caerphilly county borough and change in mental health and social cohesion. The study population is the 4226 residents aged 18–74 years who responded to the Caerphilly Health and Social Needs Study in 2001 (before delivery) and 2008 (after delivery of Communities First). Data on the location, type and cost of Communities First interventions will be extracted from records collected by Caerphilly county borough council. The primary outcome is the change in mental health between 2001 and 2008. Secondary outcomes are changes: in common mental disorder case status (using survey and general practice data), social cohesion and mental health inequalities. Multilevel models will examine change in mental health and social cohesion between Communities First and control areas, adjusting for individual and household level confounding factors. Further models will examine the effects of (1) different types of intervention, (2) contamination across areas, (3) length of residence in a Communities First area, and (4) population migration. We will carry out a cost-consequences analysis to summarise the outcomes generated for participants, as well as service utilisation and utility gains. Ethics and dissemination This study has had approval from the Information Governance Review Panel at Swansea University (Ref: 0266 CF). Findings will be disseminated through peer-review publications, international conferences, policy and practice partners in

  2. 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

  3. Extraction protocols for orthodontic treatment: A retrospective study

    PubMed Central

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

    2016-01-01

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

  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. Patient Engagement and Coaching for Health: The PEACH study – a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol

    PubMed Central

    Young, Doris; Furler, John; Vale, Margarite; Walker, Christine; Segal, Leonie; Dunning, Patricia; Best, James; Blackberry, Irene; Audehm, Ralph; Sulaiman, Nabil; Dunbar, James; Chondros, Patty

    2007-01-01

    Background The PEACH study is based on an innovative 'telephone coaching' program that has been used effectively in a post cardiac event trial. This intervention will be tested in a General Practice setting in a pragmatic trial using existing Practice Nurses (PN) as coaches for people with type 2 diabetes (T2D). Actual clinical care often fails to achieve standards, that are based on evidence that self-management interventions (educational and psychological) and intensive pharmacotherapy improve diabetes control. Telephone coaching in our study focuses on both. This paper describes our study protocol, which aims to test whether goal focused telephone coaching in T2D can improve diabetes control and reduce the treatment gap between guideline based standards and actual clinical practice. Methods/design In a cluster randomised controlled trial, general practices employing Practice Nurses (PNs) are randomly allocated to an intervention or control group. We aim to recruit 546 patients with poorly controlled T2D (HbA1c >7.5%) from 42 General Practices that employ PNs in Melbourne, Australia. PNs from General Practices allocated to the intervention group will be trained in diabetes telephone coaching focusing on biochemical targets addressing both patient self-management and engaging patients to work with their General Practitioners (GPs) to intensify pharmacological treatment according to the study clinical protocol. Patients of intervention group practices will receive 8 telephone coaching sessions and one face-to-face coaching session from existing PNs over 18 months plus usual care and outcomes will be compared to the control group, who will only receive only usual care from their GPs. The primary outcome is HbA1c levels and secondary outcomes include cardiovascular disease risk factors, behavioral risk factors and process of care measures. Discussion Understanding how to achieve comprehensive treatment of T2D in a General Practice setting is the focus of the PEACH

  7. 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

  8. Discrepancies in Outcome Reporting Exist Between Protocols and Published Oral Health Cochrane Systematic Reviews

    PubMed Central

    Pandis, Nikolaos; Fleming, Padhraig S.; Worthington, Helen; Dwan, Kerry; Salanti, Georgia

    2015-01-01

    Objectives To assess discrepancies in the analyzed outcomes between protocols and published reviews within Cochrane oral health systematic reviews (COHG) on the Cochrane Database of Systematic Reviews (CDSR). Study Design and Setting All COHG systematic reviews on the CDSR and the corresponding protocols were retrieved in November 2014 and information on the reported outcomes was recorded. Data was collected at the systematic review level by two reviewers independently. Results One hundred and fifty two reviews were included. In relation to primary outcomes, 11.2% were downgraded to secondary outcomes, 9.9% were omitted altogether in the final publication and new primary outcomes were identified in 18.4% of publications. For secondary outcomes, 2% were upgraded to primary, 12.5% were omitted and 30.9% were newly introduced in the publication. Overall, 45.4% of reviews had at least one discrepancy when compared to the protocol; these were reported in 14.5% reviews. The number of review updates appears to be associated with discrepancies between final review and protocol (OR: 3.18, 95% CI: 1.77, 5.74, p<0.001). The risk of reporting significant results was lower for both downgraded outcomes [RR: 0.52, 95% CI: 0.17, 1.58, p = 0.24] and upgraded or newly introduced outcomes [RR: 0.77, 95% CI: 0.36, 1.64, p = 0.50] compared to outcomes with no discrepancies. The risk of reporting significant results was higher for upgraded or newly introduced outcomes compared to downgraded outcomes (RR = 1.19, 95% CI: 0.65, 2.16, p = 0.57). None of the comparisons reached statistical significance. Conclusion While no evidence of selective outcome reporting was found in this study, based on the present analysis of SRs published within COHG systematic reviews, discrepancies between outcomes in pre-published protocols and final reviews continue to be common. Solutions such as the use of standardized outcomes to reduce the prevalence of this issue may need to be explored. PMID:26368938

  9. 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

  10. 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

  11. 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

  12. Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial

    PubMed Central

    2012-01-01

    Background Decreasing salt consumption can prevent cardiovascular diseases (CVD). Practically, it is difficult to promote people’s awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health. Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular diseases. Methods/Design This is a cluster randomized trial. A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District, Chiang Rai province, Thailand, will be studied with informed consent. A health center recruiting 100 participants is a cluster, the unit of randomization. Eight clusters will be randomized into intervention and control arms and followed up for 1 year. Within the intervention clusters the following will be undertaken: (1) salt content in the daily diet will be measured and shown to study participants; (2) 24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants; (3) a dietician will assist small group health education classes in cooking meals with less salt. The primary outcome is blood pressure change at the 1-year follow-up. Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake, incidence of CVD events and CVD death. The intention-to-treat analysis will be followed. Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up. Clinical CVD events and deaths will be analyzed by time-event analysis. Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally. Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model (SEM). Multilevel regression analyses will be applied. Finally, the cost effectiveness of the intervention

  13. Determinants of leptospirosis in Sri Lanka: Study Protocol

    PubMed Central

    2010-01-01

    Background Leptospirosis is becoming a major public health threat in Sri Lanka as well as in other countries. We designed a case control study to determine the factors associated with local transmission of leptospirosis in Sri Lanka, in order to identify major modifiable determinants of leptospirosis. The purpose of this paper is to describe the study protocol in detail prior to the publishing of the study results, so that the readership will be able to understand and interpret the study results effectively. Methods A hospital based partially matched case control design is proposed. The study will be conducted in three selected leptospirosis endemic districts in central Sri Lanka. Case selection will include screening all acute fever patients admitted to selected wards to select probable cases of leptospirosis and case confirmation using an array of standard laboratory criteria. Age and sex matched group of acute fever patients with other confirmed diagnosis will be used as controls. Case to control ratio will be 1:2. A minimum sample of 144 cases is required to detect 20% exposure with 95% two sided confidence level and 80% power. A pre tested interviewer administered structured questionnaire will be used to collect data from participants. Variables included in the proposed study will be evaluated using conceptual hierarch of variables in three levels; Exposure variables as proximal; reservoir and environmental variables as intermediate; socio-demographic variables as distal. This conceptual hierarch hypothesised that the distal and intermediate variables are mediated through the proximal variables but not directly. A logistic regression model will be used to analyse the probable determinants of leptospirosis. This model will evaluate the effect of same level and upper level variables on the outcome leptospirosis, using three blocks. Discussion The present national control programme of leptospirosis is hampered by lack of baseline data on leptospirosis disease

  14. 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

  15. The Ischemic Stroke Genetics Study (ISGS) Protocol

    PubMed Central

    Meschia, James F; Brott, Thomas G; Brown, Robert D; Crook, Richard JP; Frankel, Michael; Hardy, John; Merino, José G; Rich, Stephen S; Silliman, Scott; Worrall, Bradford Burke

    2003-01-01

    Background The molecular basis for the genetic risk of ischemic stroke is likely to be multigenic and influenced by environmental factors. Several small case-control studies have suggested associations between ischemic stroke and polymorphisms of genes that code for coagulation cascade proteins and platelet receptors. Our aim is to investigate potential associations between hemostatic gene polymorphisms and ischemic stroke, with particular emphasis on detailed characterization of the phenotype. Methods/Design The Ischemic Stroke Genetic Study is a prospective, multicenter genetic association study in adults with recent first-ever ischemic stroke confirmed with computed tomography or magnetic resonance imaging. Patients are evaluated at academic medical centers in the United States and compared with sex- and age-matched controls. Stroke subtypes are determined by central blinded adjudication using standardized, validated mechanistic and syndromic classification systems. The panel of genes to be tested for polymorphisms includes β-fibrinogen and platelet glycoprotein Ia, Iba, and IIb/IIIa. Immortalized cell lines are created to allow for time- and cost-efficient testing of additional candidate genes in the future. Discussion The study is designed to minimize survival bias and to allow for exploring associations between specific polymorphisms and individual subtypes of ischemic stroke. The data set will also permit the study of genetic determinants of stroke outcome. Having cell lines will permit testing of future candidate risk factor genes. PMID:12848902

  16. 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

  17. [Recommendation for studies of optimizing therapy protocols].

    PubMed

    Creutzig, U; Winkler, K

    1994-01-01

    Guidelines to establish the principles for the standard of Good Clinical Practice (GCP) for trials on medicinal products in human beings were coming into operation in the European Community in 1991. These recommendations are more extensive than those of the German drug regulatory act (AMG). Included are outlines for the protection of the patient, the responsibilities of the investigator, for biometrics and the quality assurance. Although most of the studies in pediatric oncology optimizing treatment schedules do not belong to the studies as defined by the AMG, certain rules and regulations are strictly adhered to, e.g. the Declaration of Helsinki for the protection of human rights, medical justification of involved risks, adequate and freely obtained informed consent of the patient and the parents. Furthermore, the approval of Ethics Committees must be requested. PMID:7967415

  18. 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

  19. 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

  20. 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. PMID:26518205

  1. 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

  2. Feasibility study of an optimised person-centred intervention to improve mental health and reduce antipsychotics amongst people with dementia in care homes: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background People living in care homes often have complex mental and physical health problems, disabilities and social needs which are compounded by the use of psychiatric and other drugs. In the UK dementia care is a national priority with a vast impact on services. WHELD combines the most effective elements of existing approaches to develop a comprehensive but practical intervention. This will be achieved by training care staff to provide care that is focused on an understanding of the individual and their needs; and by using additional components such as exercise, activities and social interaction to improve mental health and quality of life (QoL) and reduce the use of sedative drugs. Design Work Package 3 (WP3) is the pilot randomised trial and qualitative evaluation to help develop a future definitive randomised controlled clinical trial. The study design is a cluster randomised 2x2x2 factorial design with two replications in 16 care homes. Each care home is randomized to receive one of the eight possible permutations of the four key interventions, with each possible combination delivered in two of the 16 homes. Each cluster includes a minimum of 12 participants (depending upon size of the care home, the number of people with dementia and the number consenting). Discussion The overarching goal of the programme is to provide an effective, simple and practical intervention which improves the mental health of, and reduces sedative drug use in, people with dementia in care homes and which can be implemented nationally in all UK care homes as an NHS intervention. Trial Registration Current controlled trials ISRCTN40313497 PMID:23305152

  3. 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.

  4. 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. PMID:17353756

  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. 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

  7. Translating Culture--A Think-Aloud Protocol Study.

    ERIC Educational Resources Information Center

    Olk, Harald Martin

    2002-01-01

    Describes a think-aloud protocol study exploring translation processes of degree-level language students when dealing with culture-specific lexis. Found that one of the students' main problems was a fixation on questionable word-level parameters at the expense of text-level processes. (Author/VWL)

  8. 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

  9. 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

  10. Study protocol: the Childhood to Adolescence Transition Study (CATS)

    PubMed Central

    2013-01-01

    Background Puberty is a multifaceted developmental process that begins in late-childhood with a cascade of endocrine changes that ultimately lead to sexual maturation and reproductive capability. The transition through puberty is marked by an increased risk for the onset of a range of health problems, particularly those related to the control of behaviour and emotion. Early onset puberty is associated with a greater risk of cancers of the reproductive tract and cardiovascular disease. Previous studies have had methodological limitations and have tended to view puberty as a unitary process, with little distinction between adrenarche, gonadarche and linear growth. The Childhood to Adolescence Transition Study (CATS) aims to prospectively examine associations between the timing and stage of the different hormonally-mediated changes, as well as the onset and course of common health and behavioural problems that emerge in the transition from childhood to adolescence. The initial focus of CATS is on adrenarche, the first hormonal process in the pubertal cascade, which begins for most children at around 8 years of age. Methods/Design CATS is a longitudinal population-based cohort study. All Grade 3 students (8–9 years of age) from a stratified cluster sample of schools in Melbourne, Australia were invited to take part. In total, 1239 students and a parent/guardian were recruited to participate in the study. Measures are repeated annually and comprise student, parent and teacher questionnaires, and student anthropometric measurements. A saliva sample was collected from students at baseline and will be repeated at later waves, with the primary purpose of measuring hormonal indices of adrenarche and gonadarche. Discussion CATS is uniquely placed to capture biological and phenotypic indices of the pubertal process from its earliest manifestations, together with anthropometric measures and assessment of child health and development. The cohort will provide rich detail of

  11. The effectiveness of M-health technologies for improving health and health services: a systematic review protocol

    PubMed Central

    2010-01-01

    Background The application of mobile computing and communication technology is rapidly expanding in the fields of health care and public health. This systematic review will summarise the evidence for the effectiveness of mobile technology interventions for improving health and health service outcomes (M-health) around the world. Findings To be included in the review interventions must aim to improve or promote health or health service use and quality, employing any mobile computing and communication technology. This includes: (1) interventions designed to improve diagnosis, investigation, treatment, monitoring and management of disease; (2) interventions to deliver treatment or disease management programmes to patients, health promotion interventions, and interventions designed to improve treatment compliance; and (3) interventions to improve health care processes e.g. appointment attendance, result notification, vaccination reminders. A comprehensive, electronic search strategy will be used to identify controlled studies, published since 1990, and indexed in MEDLINE, EMBASE, PsycINFO, Global Health, Web of Science, the Cochrane Library, or the UK NHS Health Technology Assessment database. The search strategy will include terms (and synonyms) for the following mobile electronic devices (MEDs) and a range of compatible media: mobile phone; personal digital assistant (PDA); handheld computer (e.g. tablet PC); PDA phone (e.g. BlackBerry, Palm Pilot); Smartphone; enterprise digital assistant; portable media player (i.e. MP3 or MP4 player); handheld video game console. No terms for health or health service outcomes will be included, to ensure that all applications of mobile technology in public health and health services are identified. Bibliographies of primary studies and review articles meeting the inclusion criteria will be searched manually to identify further eligible studies. Data on objective and self-reported outcomes and study quality will be independently

  12. 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.

  13. Home Diuretic Protocol for Heart Failure: Partnering with Home Health to Improve Outcomes and Reduce Readmissions

    PubMed Central

    Veilleux, Richard P; Wight, Joseph N; Cannon, Ann; Whalen, Moira; Bachman, David

    2014-01-01

    Context: The management of heart failure (HF) is challenging, with high rates of readmission and no single solution. MaineHealth, a health care system serving southern Maine, has shown initial success with home health nurses partnering with physicians in the management of complex patients with HF using the MaineHealth Home Diuretic Protocol (HDP). Objective: To demonstrate that augmented diuretic therapy, both oral and intravenous, an evidence-based treatment for care of patients with HF experiencing fluid retention, can be delivered safely in the home setting using the HDP and can improve outcomes for recently hospitalized patients with HF. Design: In late 2011, the MaineHealth HDP was implemented in two hospitals and in the home health agency serving those hospitals. The patient population included recently hospitalized patients with a diagnosis of advanced HF, eligible for home health services and telemonitoring. Main Outcome Measures: Home health nurses reported data on the patients managed using the protocol, including interventions made, physical findings, lab values, and patient disposition after each episode of care. Questionnaires were used to determine patient and clinician satisfaction. Results: Sixty patients meeting the criteria above were enrolled between November 2011 and January 2014. The protocol was initiated 84 times for 30 of these patients. Sixteen patients had multiple activations. The readmission rate was 10% and no adverse outcomes were observed. Clinician and patient satisfaction was 97% or greater. Conclusion: The MaineHealth HDP can be delivered effectively and safely to improve outcomes, reducing readmissions and allowing patients to remain at home. PMID:25102518

  14. 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

  15. 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

  16. An improved protocol to study the plant cell wall proteome

    PubMed Central

    Printz, Bruno; Dos Santos Morais, Raphaël; Wienkoop, Stefanie; Sergeant, Kjell; Lutts, Stanley; Hausman, Jean-Francois; Renaut, Jenny

    2015-01-01

    Cell wall proteins were extracted from alfalfa stems according to a three-steps extraction procedure using sequentially CaCl2, EGTA, and LiCl-complemented buffers. The efficiency of this protocol for extracting cell wall proteins was compared with the two previously published methods optimized for alfalfa stem cell wall protein analysis. Following LC-MS/MS analysis the three-steps extraction procedure resulted in the identification of the highest number of cell wall proteins (242 NCBInr identifiers) and gave the lowest percentage of non-cell wall proteins (about 30%). However, the three protocols are rather complementary than substitutive since 43% of the identified proteins were specific to one protocol. This three-step protocol was therefore selected for a more detailed proteomic characterization using 2D-gel electrophoresis. With this technique, 75% of the identified proteins were shown to be fraction-specific and 72.7% were predicted as belonging to the cell wall compartment. Although, being less sensitive than LC-MS/MS approaches in detecting and identifying low-abundant proteins, gel-based approaches are valuable tools for the differentiation and relative quantification of protein isoforms and/or modified proteins. In particular isoforms, having variations in their amino-acid sequence and/or carrying different N-linked glycan chains were detected and characterized. This study highlights how the extracting protocols as well as the analytical techniques devoted to the study of the plant cell wall proteome are complementary and how they may be combined to elucidate the dynamism of the plant cell wall proteome in biological studies. Data are available via ProteomeXchange with identifier PXD001927. PMID:25914713

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

    PubMed Central

    Dolor, Rowena J; Yancy, William S; Owen, William F; Matchar, David B; Samsa, Gregory P; Pollak, Kathryn I; Lin, Pao-Hwa; Ard, Jamy D; Prempeh, Maxwell; McGuire, Heather L; Batch, Bryan C; Fan, William; Svetkey, Laura P

    2009-01-01

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

  18. A protocol for bladder cancer screening and medical surveillance among high-risk groups: The Drake Health Registry experience

    SciTech Connect

    Marsh, G.M.; Callahan, C.; Pavlock, D.; Leviton, L.C.; Talbott, E.O.; Hemstreet, G. )

    1990-09-01

    In 1986, the Drake Health Registry Study initiated bladder cancer screening for 366 persons at high risk because of occupational exposure to beta-naphthylamine. The Drake Health Registry Study screening protocol consists of urinalysis, Papanicolaou cytology, and quantitative fluorescence image analysis. A positive screening test qualifies participants for a full diagnostic evaluation. The screening protocol has been modified during the first 3 years of the program's existence to address unexpected patterns of test results and to incorporate advances in screening technology. The current protocol, which has a two-tiered screening schedule, has been utilized successfully for 15 months. Of the 26 positive results to date most have been based on abnormal Papanicolaou cytology and/or quantitative fluorescence image analysis. Bladder abnormalities were cited among most of the 18 study members who underwent diagnostic evaluation, including chronic cystitis, inflammation, hyperplasia, and dysplasia. We conclude that the screening program is detecting very early changes in a relatively young cohort and that these persons must be monitored over a number of years to ensure adequate medical surveillance.

  19. A protocol for bladder cancer screening and medical surveillance among high-risk groups: the Drake Health Registry experience.

    PubMed

    Marsh, G M; Callahan, C; Pavlock, D; Leviton, L C; Talbott, E O; Hemstreet, G

    1990-09-01

    In 1986, the Drake Health Registry Study initiated bladder cancer screening for 366 persons at high risk because of occupational exposure to beta-naphthylamine. The Drake Health Registry Study screening protocol consists of urinalysis, Papanicolaou cytology, and quantitative fluorescence image analysis. A positive screening test qualifies participants for a full diagnostic evaluation. The screening protocol has been modified during the first 3 years of the program's existence to address unexpected patterns of test results and to incorporate advances in screening technology. The current protocol, which has a two-tiered screening schedule, has been utilized successfully for 15 months. Of the 26 positive results to date most have been based on abnormal Papanicolaou cytology and/or quantitative fluorescence image analysis. Bladder abnormalities were cited among most of the 18 study members who underwent diagnostic evaluation, including chronic cystitis, inflammation, hyperplasia, and dysplasia. We conclude that the screening program is detecting very early changes in a relatively young cohort and that these persons must be monitored over a number of years to ensure adequate medical surveillance. PMID:2074513

  20. [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

  1. 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. PMID:23230645

  2. DETROIT CHILDREN'S HEALTH STUDY

    EPA Science Inventory

    The Detroit Children's Health Study will consist of health questionnaires for 15,000 children enrolled in the fourth- and fifth-grades of selected elementary schools, and measurements of lung function and exhaled breath in a subset of 3,500 of these children. Participation in bo...

  3. Comparison of Two Waist Circumference Measurement Protocols: The SEARCH for Diabetes in Youth Study

    PubMed Central

    Pettitt, David J.; Talton, Jennifer W.; Liese, Angela D.; Liu, Lenna L.; Crimmins, Nancy; West, Nancy A.; D’Agostino, Ralph B.; Kahn, Henry S.

    2012-01-01

    We compared two protocols for measuring waist circumference (WC) in a sample of youth with diabetes. Participants were enrolled in the SEARCH for Diabetes in Youth Study (SEARCH). WC was measured at least twice by the National Health and Nutrition Examination Survey (NHANES) protocol and twice by the World Health Organization (WHO) protocol. Method-specific averages were used in these analyses. Among 6248 participants, the mean NHANES WC (76.3 cm) was greater than the mean WHO WC (71.9 cm). Discrepancies between protocols were greater for females than males, among older participants, and in those with higher body mass index (BMI). In both sexes and four age strata, the WCs using either method were highly correlated with BMI z-score. The within-method differences between the first and second measurements were similar for the two methods. These analyses do not provide evidence that one of these two methods is more reproducible or is a better indicator of obesity as defined by BMI z-scores. PMID:22991230

  4. [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

  5. 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

  6. The Do-Well study: protocol for a randomised controlled trial, economic and qualitative process evaluations of domiciliary welfare rights advice for socio-economically disadvantaged older people recruited via primary health care

    PubMed Central

    2012-01-01

    Background Older people in poor health are more likely to need extra money, aids and adaptations to allow them to remain independent and cope with ill health, yet in the UK many do not claim the welfare benefits to which they are entitled. Welfare rights advice interventions lead to greater welfare income, but have not been rigorously evaluated for health benefits. This study will evaluate the effects on health and well-being of a domiciliary welfare rights advice service provided by local government or voluntary organisations in North East England for independent living, socio-economically disadvantaged older people (aged ≥60 yrs), recruited from general (primary care) practices. Methods/Design The study is a pragmatic, individually randomised, single blinded, wait-list controlled trial of welfare rights advice versus usual care, with embedded economic and qualitative process evaluations. The qualitative study will examine whether the intervention is delivered as intended; explore responses to the intervention and examine reasons for the trial findings; and explore the potential for translation of the intervention into routine policy and practice. The primary outcome is the effect on health-related quality of life, measured using the CASP 19 questionnaire. Volunteer men and women aged ≥60 years (1/household) will be identified from general practice patient registers. Patients in nursing homes or hospitals at the time of recruitment will be excluded. General practice populations will be recruited from disadvantaged areas of North East England, including urban, rural and semi-rural areas, with no previous access to targeted welfare rights advice services delivered to primary care patients. A minimum of 750 participants will be randomised to intervention and control arms in a 1:1 ratio. Discussion Achieving a trial design that is both ethical and acceptable to potential participants, required methodological compromises. The choice of follow-up length required

  7. 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

  8. 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

  9. 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

  10. A prospective study of a protocol that reduces readmission after liver transplantation.

    PubMed

    Russo, Mark W; Levi, David M; Pierce, Ruth; Casingal, Vincent; Eskind, Lon; deLemos, Andrew; Schmeltzer, Paul A; Zamor, Philippe J

    2016-06-01

    Health care has shifted to placing priority on quality and value instead of volume. Liver transplantation uses substantial resources and is associated with high readmission rates. Our goal was to determine if a protocol designed to reduce readmission after liver transplant was effective. We conducted a prospective study of a protocol designed to reduce readmission rates after liver transplantation by expanding outpatient services and alternatives to readmission. The 30-day readmission rate 1 year after implementing the protocol was compared to the 30-day rate for 2 years prior to implementation. Multivariate analysis was used to control for potential confounding factors. Over the study period, 167 adult primary liver transplants were performed with a mean biological Model for End-Stage Liver Disease score of 21 ± 8. Fifty-seven (34%) patients were readmitted. The most common reason for readmission was biliary complications (n = 13). The 30-day readmission rate decreased from 40% before implementing the protocol to 20% after implementation (P = 0.02). In multivariate analysis, the protocol remained associated with readmission (odds ratio, 0.39; 95% confidence interval, 0.16-0.92; P = 0.03). The mean length of stay after transplant was 13 ± 12 days preprotocol and 9 ± 5 days postprotocol (P = 0.09). Alternatives to readmission, including hospital lodging and observation status, were main factors in reducing readmission rates. If the most recent definitions of inpatient admission and observation status were applied over the entire study period, then the readmission rates preprotocol and postprotocol were 31% and 20% indicating that the revised definition of observation status accounted for 45% of the reduction in the readmission rate. Readmission after liver transplantation can be reduced without increasing length of stay by implementing a specifically designed protocol that expands outpatient services and alternatives to inpatient

  11. 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

  12. 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.

  13. An information manager for the Assessment Protocol for Excellence in Public Health.

    PubMed

    Vaughn, E H; Richards, T B; Christenson, G M; Taylor, M S; Eyster, J

    1994-12-01

    The Assessment Protocol for Excellence in Public Health (APEXPH) is a method for comprehensive public health planning that can be implemented by state and local health departments. Many local health departments have limited resources for the data analysis and synthesis needed for APEXPH. To facilitate the implementation of APEXPH in Michigan, we used the Centers for Disease Control and Prevention (CDC) Epi Info software package to develop an APEXPH information manager (CDC-AIM) for use by the 50 local health departments in that state. This report describes our methods for formatting, compressing, and presenting data. Examples of tables are provided for demographics by age and sex, numbers of deaths, years of potential life lost, crude mortality rates, and perinatal indicators such as low birthweight. Areas where additional work is needed to further improve CDC-AIM are discussed. Our experience in Michigan suggests that CDC-AIM potentially is an extremely helpful tool to assist state and local health departments in working with their communities to establish public health program plans based on mortality, morbidity, and risk-factor data. PMID:7870657

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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.

  19. 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. PMID:26696419

  20. AGRICULTURAL HEALTH STUDY

    EPA Science Inventory

    The Agricultural Health Study is a large cohort of 90,000 licensed pesticide applicators, plus 30,000 spouses and 20,000 children who are exposed either directly or indirectly. Exposure to pesticides is widespread and is important beyond the agricultural community. Other exposure...

  1. 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

  2. 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

  3. Protocol for a qualitative study exploring the roles of 'Diffusion Fellows' in bridging the research to practice gap in the Nottinghamshire, Derbyshire and Lincolnshire Collaboration for Leadership in Applied Health Research and Care (CLAHRC-NDL).

    PubMed

    Rowley, Emma

    2012-01-01

    Introduction Evidence produced by researchers is not comprehensibly used in practice. National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care for Nottinghamshire, Derbyshire and Lincolnshire's strategy for closing the research to practice gap relies on the use of 'Diffusion Fellows' (DFs). DFs are seconded from the local healthcare economy to act as champions for change, translating and disseminating knowledge from practice into the research studies and vice versa, taking the knowledge developed by academics back into their own practice environments. This paper outlines the rationale and design of a qualitative evaluation study of the DF role. Methods and analysis The evaluation responds to the research question: what are the barriers and facilitators to DFs acting as knowledge brokers and boundary spanners? Interviews will be carried out annually with DFs, the research team they work with and their line managers in the employing organisations. Interviews with DFs will be supplemented with a creative mapping component, offering them the opportunity to construct a 3D model to creatively illustrate some of the barriers precluding them from successfully carrying out their role. This method is popular for problem solving and is valuable for both introducing an issue that might be difficult to initially verbalise and to reflect upon experiences. Ethics and dissemination DFs have an important role within the CLAHRC and are central to our implementation and knowledge mobilisation strategies. It is important to understand as much about their activities as possible in order for the CLAHRC to support the DFs in the most appropriate way. Dissemination will occur through presentations and publications in order that learning from the use of DFs can be shared as widely as possible. The study has received ethical approval from Nottingham 2 Research Ethics Committee and has all appropriate NHS governance clearances. PMID:22267711

  4. ‘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

  5. 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

  6. 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…

  7. 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

  8. 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

  9. The efficacy of a health-related quality-of-life intervention during 48 weeks of biologic treatment of patients with moderate to severe psoriasis: study protocol for a multicenter randomized controlled trial

    PubMed Central

    2012-01-01

    Background Interest in health-related quality of life (HRQoL) outcome research in dermatology is increasing, especially in the systemic treatment of psoriasis with biologic agents. In other specialties, such as oncology, the application of a HRQoL intervention is considered to be an aid for monitoring disease and treatment over time, for the communication with the patient, and for improving treatment outcome. However, in dermatology practice, the application of this intervention is relatively new. Moreover, evidence on the effectiveness of a HRQoL intervention in dermatology is missing. It is hypothesized that the application of a HRQoL intervention in dermatology practice will have a positive impact on patients’ HRQoL as well as on doctor-patient communication. Methods/design In a prospective multicenter cluster randomized controlled trial, patients diagnosed with moderate to severe psoriasis who receive biologic treatment, will be followed for 48 weeks. The study sites, and not the patients, will be randomly allocated via a computer-based randomization system to either the intervention (treatment with etanercept and standardized HRQoL assessment and communication) or the control group (treatment with etanercept alone). The HRQoL intervention will include 1) the electronic assessment of the Skindex-29, a well-studied dermatology-specific HRQoL questionnaire, and 2) the communication of the resulting Skindex-29 data with the patient. Prior to study start, dermatologists in the intervention group will be educated and trained in standardized HRQoL assessment and communication using the Skindex-29. At six consecutive visits, patients at study sites in the intervention group will be asked to complete the Skindex-29 on a desk-top pc at the clinic, just before their consultation with the dermatologist. A print-out of the completed questionnaire will be made and, guided by this print-out, feedback on the HRQoL scores will be given during the consultation. Primary

  10. 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

  11. 3-D streaming supplying partner protocols for mobile collaborative exergaming for health.

    PubMed

    Maamar, Haifa Raja; Boukerche, Azzedine; Petriu, Emil M

    2012-11-01

    Childhood obesity is nowadays considered as one of the major health problems that many societies suffer from. The obesity epidemic leads to several life threatening conditions such as diabetes, heart disease, high blood pressure, and mental health problems like depression, anxiety and loneliness just to mention a few. Several approaches, including physical exercises, strict dietary, and exergames among others, have been adopted to address the obesity epidemic. Exergames are considered the innovative approach for fighting several health problem such as the obesity, where a combination of exercise and 3D gaming are proposed to incite kids to exercise as a team. Collaborative exergaming became even more popular given that it addresses the social side of the obesity epidemic, and it motivates kids to socialize with other kids. Traditional exergames are based on the client server approach where the server is responsible for streaming the 3D environment. However, this can lead to latency and server bottleneck if many clients participate in the exergame, which leads to the kids stopping exercising. Having an exergame application that does not suffer from networking problem such as delay, is very important given that it increases the exercise hours. In this work, we propose a new trend of mobile collaborative exergming applications that is based on the peer-to-peer (P2P) architecture, as well as two supplying partner selection protocols that aim at selecting the suitable source responsible for streaming the relevant 3D data. Our system, that we refer to as MOSAIC, is intended for mobile collaborative exergames that incite kids to move inside a large area, using thin mobile devices such as head mounted devices (HMD), have physical exercises, and collaborate with other kids which in consequence address several health problems such as the obesity epidemic on the physical and social plans. Our proposed mobile collaborative exergame aims at inciting the kids to exercise as a

  12. 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

  13. 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

  14. 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.

  15. The Agricultural Health Study.

    PubMed Central

    Alavanja, M C; Sandler, D P; McMaster, S B; Zahm, S H; McDonnell, C J; Lynch, C F; Pennybacker, M; Rothman, N; Dosemeci, M; Bond, A E; Blair, A

    1996-01-01

    The Agricultural Health Study, a large prospective cohort study has been initiated in North Carolina and Iowa. The objectives of this study are to: 1) identify and quantify cancer risks among men, women, whites, and minorities associated with direct exposure to pesticides and other agricultural agents; 2) evaluate noncancer health risks including neurotoxicity reproductive effects, immunologic effects, nonmalignant respiratory disease, kidney disease, and growth and development among children; 3) evaluate disease risks among spouses and children of farmers that may arise from direct contact with pesticides and agricultural chemicals used in the home lawns and gardens, and from indirect contact, such as spray drift, laundering work clothes, or contaminated food or water; 4) assess current and past occupational and nonoccupational agricultural exposures using periodic interviews and environmental and biologic monitoring; 5) study the relationship between agricultural exposures, biomarkers of exposure, biologic effect, and genetic susceptibility factors relevant to carcinogenesis; and 6) identify and quantify cancer and other disease risks associated with lifestyle factors such as diet, cooking practices, physical activity, smoking and alcohol consumption, and hair dye use. In the first year of a 3-year enrollment period, 26,235 people have been enrolled in the study, including 19,776 registered pesticide applicators and 6,459 spouses of registered farmer applicators. It is estimated that when the total cohort is assembled in 1997 it will include approximately 75,000 adult study subjects. Farmers, the largest group of registered pesticide applicators comprise 77% of the target population enrolled in the study. This experience compares favorably with enrollment rates of previous prospective studies. Images Figure 1. Figure 2. Figure 3. Figure 4. PMID:8732939

  16. Does a Water Protocol Improve the Hydration and Health Status of Individuals with Thin Liquid Aspiration Following Stroke? A Randomized Controlled Trial.

    PubMed

    Murray, Jo; Doeltgen, Sebastian; Miller, Michelle; Scholten, Ingrid

    2016-06-01

    The benefit of water protocols for individuals with thin liquid aspiration remains controversial, with mixed findings from a small number of randomized controlled trials (RCTs). This study aimed to contribute to the evidence of the effectiveness of water protocols with a particular emphasis on health outcomes, especially hydration. An RCT was conducted with patients with known thin liquid aspiration post stroke randomized to receiving thickened liquids only or a water protocol. For the 14 participants in rehabilitation facilities whose data proceeded to analysis, there was no difference in the total amount of beverages consumed between the water protocol group (mean = 1103 ml per day, SD = 215 ml) and the thickened liquids only group (mean = 1103 ml, SD = 247 ml). Participants in the water protocol group drank on average 299 ml (SD 274) of water but offset this by drinking less of the thickened liquids. Their hydration improved over time compared with participants in the thickened liquids only group, but differences between groups were not significant. Twenty-one percent of the total sample was diagnosed with dehydration, and no participants in either group were diagnosed with pneumonia. There were significantly more diagnoses of urinary tract infection in the thickened liquids only group compared to the water protocol group (χ (2) = 5.091, p = 0.024), but no differences between groups with regard to diagnoses of dehydration (χ (2) = 0.884, p = 0.347) or constipation (χ (2) = 0.117, p = 0.733). The findings reinforce evidence about the relative safety of water protocols for patients in rehabilitation post stroke and provide impetus for future research into the potential benefits for hydration status and minimizing adverse health outcomes. PMID:26886370

  17. 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

  18. 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

  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. PMID:23909219

  20. Telephone care coordination for smokers in VA mental health clinics: protocol for a hybrid type-2 effectiveness-implementation trial

    PubMed Central

    2013-01-01

    Background This paper describes an innovative protocol for a type-II hybrid effectiveness-implementation trial that is evaluating a smoking cessation telephone care coordination program for Veterans Health Administration (VA) mental-health clinic patients. As a hybrid trial, the protocol combines implementation science and clinical trial methods and outcomes that can inform future cessation studies and the implementation of tobacco cessation programs into routine care. The primary objectives of the trial are (1) to evaluate the process of adapting, implementing, and sustaining a smoking cessation telephone care coordination program in VA mental health clinics, (2) to determine the effectiveness of the program in promoting long-term abstinence from smoking among mental health patients, and (3) to compare the effectiveness of telephone counseling delivered by VA staff with that delivered by state quitlines. Methods/design The care coordination program is being implemented at six VA facilities. VA mental health providers refer patients to the program via an electronic medical record consult. Program staff call referred patients to offer enrollment. All patients who enroll receive a self-help booklet, mailed smoking cessation medications, and proactive multi-call telephone counseling. Participants are randomized to receive this counseling from VA staff or their state’s quitline. Four primary implementation strategies are being used to optimize program implementation and sustainability: blended facilitation, provider training, informatics support, and provider feedback. A three-phase formative evaluation is being conducted to identify barriers to, and facilitators for, program implementation and sustainability. A mixed-methods approach is being used to collect quantitative clinical effectiveness data (e.g., self-reported abstinence at six months) and both quantitative and qualitative implementation data (e.g., provider referral rates, coded interviews with providers

  1. Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial

    PubMed Central

    2013-01-01

    Background Stroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified ‘constraint-induced movement therapy (CIMT) at home’) with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. ‘CIMT at home’ will be compared with conventional physical and occupational therapy (‘therapy as usual’). Methods/design The study is a parallel cluster randomized controlled trial with therapy practices as clusters (n = 48). After written consent from the patients (n = 144), the therapists will be randomly assigned to treat either the intervention or the control group. Blinded external assessors will evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are the motor activity log (quality of arm and hand use) and the Wolf motor function test (arm and hand function). These assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes will be analyzed with mixed models, which consider the hierarchical structure of the data and will be adjusted to the baseline measurements and sex. The primary analysis will be the comparison of the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints will be tested at the

  2. 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

  3. A Protocol for Conducting Rainfall Simulation to Study Soil Runoff

    PubMed Central

    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

  4. 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

  5. Weight Status Measures Collected in the Healthy Communities Study: Protocols and Analyses.

    PubMed

    Sroka, Christopher J; McIver, Kerry L; Sagatov, Robyn D F; Arteaga, S Sonia; Frongillo, Edward A

    2015-10-01

    The Healthy Communities Study is one of the largest studies to assess the relationship between characteristics of community programs and policies to prevent childhood obesity and obesity-related outcomes. The purpose of this paper is to describe the protocol that was developed for collecting the anthropometric data for the study and the procedures for analyzing the data. Data were collected from 2013 to 2015 and analyses will be completed by mid-2016. During in-home visits, Healthy Communities Study staff collected height, weight, and waist circumference measurements from child participants and height and weight measurements from adult participants. The protocol for obtaining these measurements was adapted from the protocol used by the National Health and Nutrition Examination Survey, with modifications to accommodate assessments conducted in homes rather than in a Mobile Examination Center. In addition to anthropometric data from in-home visits, the Healthy Communities Study collected retrospective height and weight measurements from the medical records of child participants. These data were used to calculate trajectories of BMI and BMI z-scores. The study implemented procedures for ensuring the accuracy of the in-home measurements and abstracted medical data. These procedures included automatically checking the ranges on entered data, reviewing data for end-digit patterns, and abstracting selected medical records using two independent abstractors to assess agreement. The collection of longitudinal height and weight measures will allow researchers to address several pressing questions related to how characteristics of community programs and policies are associated with obesity-related outcomes among children. PMID:26384935

  6. 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

  7. 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

  8. Strategies to assess the validity of recommendations: a study protocol

    PubMed Central

    2013-01-01

    Background Clinical practice guidelines (CPGs) become quickly outdated and require a periodic reassessment of evidence research to maintain their validity. However, there is little research about this topic. Our project will provide evidence for some of the most pressing questions in this field: 1) what is the average time for recommendations to become out of date?; 2) what is the comparative performance of two restricted search strategies to evaluate the need to update recommendations?; and 3) what is the feasibility of a more regular monitoring and updating strategy compared to usual practice?. In this protocol we will focus on questions one and two. Methods The CPG Development Programme of the Spanish Ministry of Health developed 14 CPGs between 2008 and 2009. We will stratify guidelines by topic and by publication year, and include one CPG by strata. We will develop a strategy to assess the validity of CPG recommendations, which includes a baseline survey of clinical experts, an update of the original exhaustive literature searches, the identification of key references (reference that trigger a potential recommendation update), and the assessment of the potential changes in each recommendation. We will run two alternative search strategies to efficiently identify important new evidence: 1) PLUS search based in McMaster Premium LiteratUre Service (PLUS) database; and 2) a Restrictive Search (ReSe) based on the least number of MeSH terms and free text words needed to locate all the references of each original recommendation. We will perform a survival analysis of recommendations using the Kaplan-Meier method and we will use the log-rank test to analyse differences between survival curves according to the topic, the purpose, the strength of recommendations and the turnover. We will retrieve key references from the exhaustive search and evaluate their presence in the PLUS and ReSe search results. Discussion Our project, using a highly structured and transparent

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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

  16. 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

  17. Protocols to Study the Physiology of Oral Biofilms

    PubMed Central

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

    2011-01-01

    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. PMID:20717780

  18. 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

  19. NHEXAS PHASE I MARYLAND STUDY--LIST OF AVAILABLE DOCUMENTS: PROTOCOLS AND SOPS

    EPA Science Inventory

    This document lists available protocols and SOPs for the NHEXAS Phase I Maryland study. It identifies protocols and SOPs for the following study components: (1) Sample collection and field operations, (2) Sample analysis and general laboratory procedures, (3) Data Analysis Proced...

  20. 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.

  1. Assessing health systems for type 1 diabetes in sub-Saharan Africa: developing a 'Rapid Assessment Protocol for Insulin Access'

    PubMed Central

    Beran, David; Yudkin, John S; de Courten, Maximilian

    2006-01-01

    Background In order to improve the health of people with Type 1 diabetes in developing countries, a clear analysis of the constraints to insulin access and diabetes care is needed. We developed a Rapid Assessment Protocol for Insulin Access, comprising a series of questionnaires as well as a protocol for the gathering of other data through site visits, discussions, and document reviews. Methods The Rapid Assessment Protocol for Insulin Access draws on the principles of Rapid Assessment Protocols which have been developed and implemented in several different areas. This protocol was adapted through a thorough literature review on diabetes, chronic condition management and medicine supply in developing countries. A visit to three countries in sub-Saharan Africa and meetings with different experts in the field of diabetes helped refine the questionnaires. Following the development of the questionnaires these were tested with various people familiar with diabetes and/or healthcare in developing countries. The Protocol was piloted in Mozambique then refined and had two further iterations in Zambia and Mali. Translations of questionnaires were made into local languages when necessary, with back translation to ensure precision. Results In each country the protocol was implemented in 3 areas – the capital city, a large urban centre and a predominantly rural area and their respective surroundings. Interviews were carried out by local teams trained on how to use the tool. Data was then collected and entered into a database for analysis. Conclusion The Rapid Assessment Protocol for Insulin Access was developed to provide a situational analysis of Type 1 diabetes, in order to make recommendations to the national Ministries of Health and Diabetes Associations. It provided valuable information on patients' access to insulin, syringes, monitoring and care. It was thus able to sketch a picture of the health care system with regards to its ability to care for people with diabetes

  2. 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

  3. Plain packaging of cigarettes and smoking behavior: study protocol for a randomized controlled study

    PubMed Central

    2014-01-01

    Background Previous research on the effects of plain packaging has largely relied on self-report measures. Here we describe the protocol of a randomized controlled trial investigating the effect of the plain packaging of cigarettes on smoking behavior in a real-world setting. Methods/Design In a parallel group randomization design, 128 daily cigarette smokers (50% male, 50% female) will attend an initial screening session and be assigned plain or branded packs of cigarettes to smoke for a full day. Plain packs will be those currently used in Australia where plain packaging has been introduced, while branded packs will be those currently used in the United Kingdom. Our primary study outcomes will be smoking behavior (self-reported number of cigarettes smoked and volume of smoke inhaled per cigarette as measured using a smoking topography device). Secondary outcomes measured pre- and post-intervention will be smoking urges, motivation to quit smoking, and perceived taste of the cigarettes. Secondary outcomes measured post-intervention only will be experience of smoking from the cigarette pack, overall experience of smoking, attributes of the cigarette pack, perceptions of the on-packet health warnings, behavior changes, views on plain packaging, and the rewarding value of smoking. Sex differences will be explored for all analyses. Discussion This study is novel in its approach to assessing the impact of plain packaging on actual smoking behavior. This research will help inform policymakers about the effectiveness of plain packaging as a tobacco control measure. Trial registration Current Controlled Trials ISRCTN52982308 (registered 27 June 2013). PMID:24965551

  4. Exposing the impact of Citizens Advice Bureau services on health: a realist evaluation protocol

    PubMed Central

    Forster, N; Dalkin, S M; Lhussier, M; Hodgson, P; Carr, S M

    2016-01-01

    Introduction Welfare advice services can be used to address health inequalities, for example, through Citizens Advice Bureau (CAB). Recent reviews highlight evidence for the impact of advice services in improving people's financial position and improving mental health and well-being, daily living and social relationships. There is also some evidence for the impact of advice services in increasing accessibility of health services, and reducing general practitioner appointments and prescriptions. However, direct evidence for the impact of advice services on lifestyle behaviour and physical health is currently much less well established. There is a need for greater empirical testing of theories around the specific mechanisms through which advice services and associated financial or non-financial benefits may generate health improvements. Methods and analysis A realist evaluation will be conducted, operationalised in 5 phases: building the explanatory framework; refining the explanatory framework; testing the explanatory framework through empirical data (mixed methods); development of a bespoke data recording template to capture longer term impact; and verification of findings with a range of CAB services. This research will therefore aim to build, refine and test an explanatory framework about how CAB services can be optimally implemented to achieve health improvement. Ethics and dissemination The study was approved by the ethics committee at Northumbria University, UK. Project-related ethical issues are described and quality control aspects of the study are considered. A stakeholder mapping exercise will inform the dissemination of results in order to ensure all relevant institutions and organisations are targeted. PMID:26792219

  5. 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

  6. Centrifugation protocol for the NASA Artificial Gravity-Bed Rest Pilot Study.

    PubMed

    Arya, Maneesh; Paloski, William H; Young, Laurence R

    2007-07-01

    We have implemented a 41-day ground-based study to investigate the effects of daily artificial gravity loading on bed rest deconditioned human subjects. Each subject underwent 21 days of 6 degree head-down bed rest. Treatment subjects received 60 min daily doses of inertial mechanical loading (2.5 G at the feet decreasing to 1 G at the heart) produced by a short radius centrifuge. During rotation, the subject's cardiovascular responses were monitored via ECG, blood pressure and pulse oximetry, and subjective assessment of motion sickness and overall health were periodically requested. The subject's weight distribution at the feet was measured using a force plate, and lower leg muscle activity was monitored via surface electromyography. Control subjects were instrumented but did not receive any centrifugation. This paper provides details on the centrifuge protocol development and efficacy. PMID:18372684

  7. 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

  8. 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

  9. 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

  10. 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. PMID:26499320

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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…

  16. EL PASO CHILDREN'S HEALTH STUDY

    EPA Science Inventory

    The El Paso Childrens Health Study consisted of two waves of exposure monitoring, respiratory health questionnaires, and lung function examinations. The exposure assessment began with a pilot study using passive samplers for nitrogen dioxide in February, 1999 and was followed b...

  17. 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

  18. Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT)

    PubMed Central

    2014-01-01

    Background Stress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being. Methods/Design The purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment, referral, and cognitive behavior therapy (CBT) for pregnant women compared to usual prenatal care (no formal screening or specialized care). The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks postrandomization. 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; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. Pregnant women are eligible if they: 1) are <28 weeks gestation; 2) speak/read English; 3) are willing to complete email questionnaires; 4) have no, low, or moderate psychosocial risk on screening at recruitment; and 5) are eligible for CBT. A sample of 816 women will be recruited from large, urban primary care clinics and allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment, and those with mild or moderate depression, anxiety, or stress symptoms then complete six interactive cognitive behavior therapy modules. All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3, 6, and 12 months postpartum

  19. HEALTH AND RETIREMENT STUDY (HRS)

    EPA Science Inventory

    HRS is a national panel study based on biennial interviews. The study provides a portrait of an aging America's physical and mental health, insurance coverage, financial status, family support systems, labor market status, and retirement planning.

  20. 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. PMID:24691389

  1. 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

  2. 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.

  3. 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

  4. Protocol Design for Large-Scale Cross-Sectional Studies of Sexual Abuse and Associated Factors in Individual Sports: Feasibility Study in Swedish Athletics

    PubMed Central

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

    2015-01-01

    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 A

  5. 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

  6. Effects on instruments of the World Health Organization--recommended protocols for decontamination after possible exposure to transmissible spongiform encephalopathy-contaminated tissue.

    PubMed

    Brown, Stanley A; Merritt, Katharine; Woods, Terry O; Busick, Deanna N

    2005-01-15

    It has been recommended by the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) that rigorous decontamination protocols be used on surgical instruments that have been exposed to tissue possibly contaminated with Creutzfeldt-Jakob disease (CJD). This study was designed to examine the effects of these protocols on various types of surgical instruments. The most important conclusions are: (1) autoclaving in 1N NaOH will cause darkening of some instruments; (2) soaking in 1N NaOH at room temperature damages carbon steel but not stainless steel or titanium; (3) soaking in chlorine bleach will badly corrode gold-plated instruments and will damage some, but not all, stainless-steel instruments, especially welded and soldered joints. Damage became apparent after the first exposure and therefore long tests are not necessary to establish which instruments will be damaged. PMID:15449256

  7. Cell phone-supported cognitive behavioural therapy for anxiety disorders: a protocol for effectiveness studies in frontline settings

    PubMed Central

    2011-01-01

    Background Reviews of randomized controlled trials (RCTs) of cognitive behavioural therapy (CBT) for anxiety disorders have reported large pre- to post-treatment within-group effect sizes on measures of anxiety when supplied in therapist consultations and in technology-supported settings. However, the stringent experimental control of RCTs results in a lack of external validity, which limits the generalizability of findings to real-world frontline clinical practice. We set out to examine the specification of a protocol for study of the effectiveness of cell phone-supported CBT for in situ management of anxiety disorders. Methods and design Nominal group methods were used for requirements analysis and protocol design. Making a distinction between different forms of technology-supported therapy, examination of therapists' role, and implementing trials in existing organizational and community contexts were found to be the central requirements in the protocol. Discussion The resulting protocol (NCT01205191 at clinicaltrials.gov) for use in frontline clinical practice in which effectiveness, adherence, and the role of the therapists are analyzed, provides evidence for what are truly valuable cell phone-supported CBT treatments and guidance for the broader introduction of CBT in health services. PMID:21219593

  8. Recommended protocols based on a survey of current practice in genotoxicity testing laboratories: study evaluation.

    PubMed

    Brillinger, R L; Nestmann, E R; Sigal, E A; Swierenga, S H

    1991-02-01

    The approach used in the survey of current methodologies used in mammalian cell genotoxicity testing (unscheduled DNA synthesis, mutation, cell transformation and cytogenetics testing) is discussed. The recommended protocols, described in the preceding papers, were developed using responses to detailed questionnaires. This summary outlines general observations related to the survey methodology and to the protocols themselves. Also discussed are the qualities of an effective survey; the evolution of a survey and of a protocol; and the contributions and limitations of this study. PMID:1996127

  9. Wraparound care for youth injured by violence: study protocol for a pilot randomised control trial

    PubMed Central

    Snider, Carolyn; Jiang, Depeng; Logsetty, Sarvesh; Strome, Trevor; Klassen, Terry

    2015-01-01

    Introduction Injury by violence is the fourth cause of death and the leading reason for a youth to visit an emergency department (ED) in Canada. In Winnipeg, 20% of youth who visit an ED with an injury due to violence have a second visit for a subsequent violent injury within 1 year. Youth injured by violence are in a reflective and receptive state of mind, rendering the ED setting appropriate for intervention. Methods and analysis This protocol describes a wraparound care model delivered by a support worker with lived experience with violence, supported by social workers and links to multiple community partners. Support workers will be on call 24 h a day, 7 days a week in order to start the intervention in the ED and take advantage of the ‘teachable moment’. The protocol is of a pilot randomised control trial to assess the feasibility of a randomised control trial designed to assess efficacy. For the pilot trial, we will assess recruitment, treatment fidelity, participant adherence and safety. The intervention arm will receive wraparound care initiated at the time of their visit for injury due to violence. The control arm will receive standard care. We will use an adapted preconsent randomisation methodology. This intervention has been developed using an integrated knowledge translation approach. Discussion Interventions delivered in the ED for youth injured by violence require an approach that is appropriate for the unique situation the youth are in. Ethics The University of Manitoba Health Research Ethics Board (HS 16445 (Cohort study) and HS 16444 (WrapAround Care study) granted ethical approval. Trial registration number NCT01895738. PMID:25991461

  10. 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

  11. 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

  12. Wikis and Collaborative Writing Applications in Health Care: A Scoping Review Protocol

    PubMed Central

    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

    2012-01-01

    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

  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. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. TABADO: "Evaluation of a smoking cessation program among Adolescents in Vocational Training Centers": Study protocol

    PubMed Central

    2009-01-01

    Background Most of the efforts to reduce teenagers' tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program (TABADO study), associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees), was developed. This study aims to evaluate the efficacy of the program which was offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC). This paper presents the TABADO study protocol. Methods The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC in Lorraine, France, during the 2008-2009 period. The intervention group (1000 trainees) benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees) other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months. Discussion If the program proves effective, it will be a new tool in the action against smoking in populations that have been seldom targeted until now. In addition, the approach could be expanded to other young subjects from socially disadvantaged backgrounds in the context of a public health policy against smoking among adolescents. Trial registration Clinical trial identification number is NTC00973570. PMID:19912627

  20. Panax ginseng therapy for chronic obstructive pulmonary disease: a clinical trial protocol and pilot study

    PubMed Central

    2014-01-01

    Background Panax ginseng (Ren shen) has been used to treat chronic obstructive pulmonary disease (COPD). This article aims to present a study protocol and pilot trial comparing P. ginseng with placebo for treating moderate to very severe COPD. Methods COPD was diagnosed spirometrically, with participants having a forced expiratory volume in one second (FEV1) of between 20% and 79% and FEV1 to forced vital capacity (FVC) ratio of less than 70%. Outcome measures included exacerbation rate, St. Georges Respiratory Questionnaire, COPD Assessment Test and Short-form Health Survey (SF-36). Other outcome measures included the six-minute walk test, FEV1, FVC, relief medication use, use of COPD-specific medical resources, and adverse events. The study is a randomized, double-blind, placebo controlled clinical trial. The method of this pilot trial was based on a planned full-scale trial except that participants were enrolled for ten weeks compared to 52 weeks. In the pilot trial, 14 participants (57–73 years old) with moderate to very severe COPD were recruited from a community health program at a public Chinese medicine hospital in Guangdong Province, China. After a 2-week run-in period, 10 participants were eligible for the study and were randomly assigned to either P. ginseng group (n = 5) (200 mg twice daily for four weeks) or placebo group (n = 5), and then followed-up for an additional 4 weeks for a total of 10 weeks. Results Nine participants completed the trial and one dropped out. The exacerbation rate could not be evaluated because there were no exacerbations. One participant in P. ginseng group reported events of sore throat, cough and fever. Trial investigators did not consider these events as COPD exacerbations or adverse events. Conclusions Participant recruitment, study design, data collection and outcome measurement have been tested in a pilot trial. A full-scale trial is warranted. PMID:25161696

  1. Multimorbidity in primary care: protocol of a national cross-sectional study in Switzerland

    PubMed Central

    Déruaz-Luyet, Anouk; N'Goran, A Alexandra; Tandjung, Ryan; Frey, Peter; Zeller, Andreas; Haller, Dagmar M; Rosemann, Thomas; Burnand, Bernard; Bodenmann, Patrick; Senn, Nicolas; Widmer, Daniel; Herzig, Lilli

    2015-01-01

    Introduction With the ageing of the population and the general improvement of care, an increasing number of people are living with multiple chronic health conditions or ‘multimorbidity’. Multimorbidity often implies multiple medical treatments. As a consequence, the risk of adverse events and the time spent by patients for their treatments increase exponentially. In many cases, treatment guidelines traditionally defined for single conditions are not easily applicable. Primary care for individuals with multimorbidity requires complex patient-centred care and good communication between the patient and the general practitioner (GP). This often includes prioritising among the different chronic conditions. Methods and analysis The main objectives of this study are to describe the burden related to multimorbidity (disease-related burden and burden of treatment) in primary care and to identify the factors influencing it. Other objectives include evaluating patients’ perception of treatment burden and quality of life, assessing factors influencing that perception, and investigating prioritisation in the management of multimorbidity from the perspectives of GPs and patients. For this cross-sectional study, patient enrolment will take place in GP's private practices across Switzerland. A convenient sample of 100 GPs will participate; overall, 1000 patients with at least three chronic health conditions will be enrolled. Data will be collected as paper-based questionnaires for GPs and delayed telephone interview questionnaires for patients. GPs will provide demographic and practice-related data. In addition, each GP will complete a paper-based questionnaire for each patient that they enrol. Each patient will complete a telephone interview questionnaire. Ethics and dissemination This study has been approved by the research ethics committee of Canton Vaud, Switzerland (Protocol 315/14). The results of the study will be reported in international peer-reviewed journals. PMID

  2. Factors that affect the uptake of community-based health insurance in low-income and middle-income countries: a systematic protocol

    PubMed Central

    Adebayo, Esther F; Ataguba, John E; Uthman, Olalekan A; Okwundu, Charles I; Lamont, Kim T; Wiysonge, Charles S

    2014-01-01

    Introduction Many people residing in low-income and middle-income countries (LMICs) are regularly exposed to catastrophic healthcare expenditure. It is therefore pertinent that LMICs should finance their health systems in ways that ensure that their citizens can use needed healthcare services and are protected from potential impoverishment arising from having to pay for services. Ways of financing health systems include government funding, health insurance schemes and out-of-pocket payment. A health insurance scheme refers to pooling of prepaid funds in a way that allows for risks to be shared. The health insurance scheme particularly suitable for the rural poor and the informal sector in LMICs is community-based health insurance (CBHI), that is, insurance schemes operated by organisations other than governments or private for-profit companies. We plan to search for and summarise currently available evidence on factors associated with the uptake of CBHI, as we are not aware of previous systematic reviews that have looked at this important topic. Methods This is a protocol for a systematic review of the literature. We will include both quantitative and qualitative studies in this review. Eligible quantitative studies include intervention and observational studies. Qualitative studies to be included are focus group discussions, direct observations, interviews, case studies and ethnography. We will search EMBASE, PubMed, Scopus, ERIC, PsycInfo, Africa-Wide Information, Academic Search Premier, Business Source Premier, WHOLIS, CINAHL and the Cochrane Library for eligible studies available by 31 October 2013, regardless of publication status or language of publication. We will also check reference lists of included studies and proceedings of relevant conferences and contact researchers for eligible studies. Two authors will independently screen the search output, select studies and extract data, resolving discrepancies by consensus and discussion. Qualitative data will

  3. 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

  4. AGRICULTURAL HEALTH STUDY/PESTICIDE EXPOSURE STUDY

    EPA Science Inventory

    The Agricultural Health Study (AHS) is a prospective epidemiologic study of a large cohort of pesticide applicators and their spouses in Iowa and North Carolina. The Pesticide Exposure Study is a sub-study to evaluate exposure factors and to provide data to assess exposure cla...

  5. A randomised controlled trial of a tele-based lifestyle intervention for colorectal cancer survivors ('CanChange'): study protocol

    PubMed Central

    2009-01-01

    Background Colorectal cancer survivors may suffer from a range of ongoing psychosocial and physical problems that negatively impact on quality of life. This paper presents the study protocol for a novel telephone-delivered intervention to improve lifestyle factors and health outcomes for colorectal cancer survivors. Methods/Design Approximately 350 recently diagnosed colorectal cancer survivors will be recruited through the Queensland Cancer Registry and randomised to the intervention or control condition. The intervention focuses on symptom management, lifestyle and psychosocial support to assist participants to make improvements in lifestyle factors (physical activity, healthy diet, weight management, and smoking cessation) and health outcomes. Participants will receive up to 11 telephone-delivered sessions over a 6 month period from a qualified health professional or 'health coach'. Data collection will occur at baseline (Time 1), post-intervention or six months follow-up (Time 2), and at 12 months follow-up for longer term effects (Time 3). Primary outcome measures will include physical activity, cancer-related fatigue and quality of life. A cost-effective analysis of the costs and outcomes for survivors in the intervention and control conditions will be conducted from the perspective of health care costs to the government. Discussion The study will provide valuable information about an innovative intervention to improve lifestyle factors and health outcomes for colorectal cancer survivors. Trial Registration ACTRN12608000399392 PMID:19689801

  6. 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

  7. INTERLABORATORY STUDY OF AN EPA (ENVIRONMENTAL PROTECTION AGENCY)/AMES/SALMONELLA TEST PROTOCOL

    EPA Science Inventory

    Seven laboratories participated in a collaborative study to evaluate a proposed EPA standard protocol for the Ames test. The study utilized Salmonella typhimurium strains TA98 and TA100 with three metabolic activation levels (0, 2, and coded unknowns. The three primary study goal...

  8. Effectiveness of cognitive behavioural therapy augmentation in major depression treatment (ECAM study): study protocol for a randomised clinical trial

    PubMed Central

    Nakagawa, Atsuo; Sado, Mitsuhiro; Mitsuda, Dai; Fujisawa, Daisuke; Kikuchi, Toshiaki; Abe, Takayuki; Sato, Yuji; Iwashita, Satoru; Mimura, Masaru; Ono, Yutaka

    2014-01-01

    Introduction Major depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society. Although antidepressant treatment is the most common therapy provided in routine practice, there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants. The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy (CBT) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care. Methods and analysis The current study is a 16-week assessor-blinded randomised, parallel-groups superiority trial with 12-month follow-up at an outpatient clinic as part of usual depression care. Patients aged 20–65 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Major Depressive Disorder who have experienced at least one failed trial of antidepressants as part of usual depression care, will be randomly assigned to receive CBT plus treatment as usual, or treatment as usual alone. The primary outcome is the change in clinician-rated 17-item GRID-Hamilton Depression Rating Scale (GRID-HAMD) score at 16 weeks, and secondary outcomes include severity and change in scores of subjective depression symptoms, proportion of responders and remitters, safety and quality of life. The primary population will be the intention-to-treat patients. Ethics and dissemination All protocols and the informed consent form comply with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol. The results of the study will be disseminated at several research conferences and as published articles in peer

  9. 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

  10. Situated Protocols: Studying a College Student's Writing in Classroom Contexts.

    ERIC Educational Resources Information Center

    McCarthy, Lucille

    A study examined the writing experiences of three college students during their freshman and sophomore years to determine how students in a classroom setting determine the writing requirements of that discipline and for that teacher, and how they go about producing their writing assignments. The study used ethnographic observation and interviews,…

  11. 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

  12. 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.

  13. 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

  14. 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

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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 ur...

  16. 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

  17. 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

  18. Patient safety in Dutch primary care: a study protocol

    PubMed Central

    2010-01-01

    Background Insight into the frequency and seriousness of potentially unsafe situations may be the first step towards improving patient safety. Most patient safety attention has been paid to patient safety in hospitals. However, in many countries, patients receive most of their healthcare in primary care settings. There is little concrete information about patient safety in primary care in the Netherlands. The overall aim of this study was to provide insight into the current patient safety issues in Dutch general practices, out-of-hours primary care centres, general dental practices, midwifery practices, and allied healthcare practices. The objectives of this study are: to determine the frequency, type, impact, and causes of incidents found in the records of primary care patients; to determine the type, impact, and causes of incidents reported by Dutch healthcare professionals; and to provide insight into patient safety management in primary care practices. Design and methods The study consists of three parts: a retrospective patient record study of 1,000 records per practice type was conducted to determine the frequency, type, impact, and causes of incidents found in the records of primary care patients (objective one); a prospective component concerns an incident-reporting study in each of the participating practices, during two successive weeks, to determine the type, impact, and causes of incidents reported by Dutch healthcare professionals (objective two); to provide insight into patient safety management in Dutch primary care practices (objective three), we surveyed organizational and cultural items relating to patient safety. We analysed the incidents found in the retrospective patient record study and the prospective incident-reporting study by type of incident, causes (Eindhoven Classification Model), actual harm (severity-of-outcome domain of the International Taxonomy of Medical Errors in Primary Care), and probability of severe harm or death. Discussion

  19. The Deckled Incision: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Lord, Sarah J; Ngo, Quan

    2016-01-01

    Background Scar visibility is multifactorial and skin closure technique is thought to play an important role. It is an established principle in plastic surgery that Z plasties generally reduce scar contracture by breaking up the lines of tension in a wound. As an extension of this principle, it is postulated that irregular “deckled” skin incisions made during tumor excision would produce aesthetically superior scars. Objective The primary objective of this study is to assess both the clinician and patient opinion of scar quality using the Patient and Observer Scar Assessment Scale (POSAS). Secondary objectives include the proportion of scars judged as good by the both the patient and clinician (less than or equal to 5 on the overall PSOAS scale), the number of adverse events, and the proportion of the scar visible at 1 meter. Methods The deckling study will be a patient-blinded, simple randomized controlled trial (RCT) at a single center institution. The two groups will be equally allocated on a 1:1 ratio into the control and treatment arms. All patients greater than 18 years of age undergoing a plastic surgery procedure involving excision of skin lesions will be enrolled. Any patients requiring re-excision through the wound or undergoing injectable corticosteroid therapy will be excluded. A total of 500 patients will be enrolled. The patients will be followed-up at 1 week, 3 months, and 6 months post-operatively. Results The study is expected to begin enrolment in August 2016. We anticipate that the deckling study group will have superior scar outcomes when compared to the straight line incision. From clinical experience this is especially true for lesions involving the face and in those areas of the skin that have undergone radiation therapy. The study will be funded by the Plastics and Reconstructive Surgery Department at St Vincent’s Hospital, Sydney, Australia. Ethics approval has been obtained for the study. Conclusion: We believe this will be an

  20. 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

  1. Study Protocol: Asymptomatic Intracranial Atherosclerotic Disease in Pakistanis

    PubMed Central

    Kamal, Ayeesha Kamran; Majeed, Farzin; Pasha, Omrana; Islam, Muhammad; Azam, Iqbal; Ilyas, Muhammad Saleem; Hussain, Munawar; Masood, Kamran; Ahmed, Bilal; Nazir, Sumaira; Sajjad, Zafar; Kasner, Scott E.

    2015-01-01

    Background Intracranial atherosclerotic disease (ICAD) is the most frequent subtype of ischemic stroke globally. It is important to describe the determinants of early ICAD as a strategy to prevent strokes from clinically evident and progressive ICAD. Our objective is to report the determinants of asymptomatic ICAD by linking the presence or absence of ICAD on magnetic resonance angiogram (MRA) with detailed risk assessment in asymptomatic adults. Methods This is an observational cross-sectional analytical study. We plan to recruit 200 adult participants from the radiology departments of two tertiary care centers of Karachi, Pakistan. The participants will first be screened for the absence of stroke symptoms via the Questionnaire for Verifying Stroke Free Status (QVSFS). QVSFS negative will be participants will be eligible. After written informed consent, participants will undergo detailed medical, sociodemographic, lifestyle, and anthropometric evaluation by a detailed interview. They will, in addition, undergo MRA to study the presence, degree, and distribution of asymptomatic ICAD. All MRA scans will be reviewed centrally by vascular neurologists blinded to clinical information. These images would be reviewed on DICOM Viewer 3.0 used for calculating the degree of stenosis using Warfarin–Aspirin Symptomatic Intracranial Disease (WASID) study defined criteria employing electronic calipers. A sample size of 200 will achieve 80% power for detecting a minimum difference of 20% in the prevalence of exposure factors (medical and lifestyle) between asymptomatic ICAD positive and ICAD negative persons. This study will generate regional data on risks for ICAD development and prevention in a high-risk susceptible population. Study ID: NCT02072876 PMID:25825629

  2. Calibration and data collection protocols for reliable lattice parameter values in electron pair distribution function studies

    SciTech Connect

    Abeykoon, A. M. Milinda; Hu, Hefei; Wu, Lijun; Zhu, Yimei; Billinge, Simon J. L.

    2015-01-30

    Different protocols for calibrating electron pair distribution function (ePDF) measurements are explored and described for quantitative studies on nanomaterials. It is found that the most accurate approach to determine the camera length is to use a standard calibration sample of Au nanoparticles from the 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.

  3. Pedestrian Road-Crossing Behaviours: A Protocol for an Explanatory Mixed Methods Study

    PubMed Central

    Hashemiparast, Mina; Montazeri, Ali; Nedjat, Saharnaz; Negarandeh, Reza; Sadeghi, Roya; Hosseini, Masoumeh; Garmaroudi, Gholamreza

    2016-01-01

    Background: Pedestrian crossing is an important traffic safety concern. The aim of this paper is to report the protocol for a sequential explanatory mixed methods study that set out to determine the pedestrians’ traffic behaviors, the associated factors and exploring the perception of young people about the traffic risky behaviors in crossing the road. The ultimate purpose of the study is to design a preventive and cultural based strategy to promote young people’s health. Methods: This is a sequential explanatory mixed methods design. The study has two sequential phases. During the first phase, a population-based cross-sectional survey of a sample of young people will be conducted using the proportional random multistage cluster sampling method, in Tehran, Iran. Data will be collected by a questionnaire including items on socio-demographic information, items on measuring social conformity tendency, and questions on subjective norms, attitudes, and perceived behavioral control based on the Theory of Planned behavior. In the second phase, a qualitative study will be conducted. A purposeful sampling strategy will be used and participants who can help to explain the quantitative findings will be selected. Data collection in qualitative phase will be predominately by individual in-depth interviews. A qualitative content analysis approach will be undertaken to develop a detailed understanding of the traffic risky behaviors among young pedestrians. Conclusion: The findings of this explanatory mixed methods study will provide information on traffic risky behaviors in young pedestrians. The findings will be implemented to design a cultural based strategy and intervention programs. PMID:26652086

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Collaborative Behavioral Teratology Study: protocol design and testing procedures.

    PubMed

    Adams, J; Buelke-Sam, J; Kimmel, C A; Nelson, C J; Reiter, L W; Sobotka, T J; Tilson, H A; Nelson, B K

    1985-01-01

    This paper presents background information on the methods used in the Collaborative Behavioral Teratology Study (CBTS), the rationale behind the experimental design, and the design and specific procedures used in the CBTS. Each of the following methods is discussed: negative geotaxis, olfactory discrimination, auditory startle habituation, one-hour activity in the figure-8 maze, visual discrimination learning, 23-hour activity in the figure-8 maze, and amphetamine-stimulated activity. The CBTS was designed to determine the intra- and interlaboratory reliability of these test methods and the detection sensitivity of each method, as well as to determine the importance of several major variables (early test experience, gender, litter). The important design features which permitted these evaluations are discussed. Each laboratory conducted two independent experiments: one using d-amphetamine sulfate as the test agent and one using methylmercuric chloride. Other than the use of different agents and dosing regimens in the two studies, all other characteristics of experimental design were identical. Each study was conducted in four replicates with 4 litters/each of 4 treatment groups/replicate. The replicate design was an important feature which permitted reliability of the tests to be addressed under conditions in which several other sources of variation in responding could be identified and accounted for in the model. Other methods by which optimal testing conditions were implemented in the participating laboratories included the "blind" testing of all subjects in specific orders which were counterbalanced for treatment group, time of day, and the apparatus in which the animals were placed.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:3835452

  11. 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

  12. Auricular point acupressure for chronic pain: a feasibility study of a 4-week treatment protocol.

    PubMed

    Yeh, Chao Hsing; Chien, Lung-Chang; Huang, Li Chun; Suen, Lorna Kwai-Ping

    2014-01-01

    This 1-group, 4-week observational study aimed to (1) assess the feasibility of recruiting, retention, and completion of a 4-week auricular point acupressure (APA) treatment protocol for chronic pain in adult patients and (2) assess the effects of APA in pain reduction (pain severity and pain interference) among these patients. The participants received a 4-week APA treatment protocol in weekly cycles. Each weekly cycle included 5 days with APA seeds taped onto the ear and 2 days without. Each participant was called every day to monitor adherence to the treatment protocol (the actual times the participant pressed the seeds each day and the duration of applied pressure), to answer analgesic use, and to answer the pain intensity questionnaire. Thirty participants were initially enrolled in this study, but 5 did not continue. The retention rate was 83% (n = 25). Approximately 60% of the participants (n = 15) adhered to the 4-week APA and completed all data assessments. At baseline assessment, only 40% of all participants (n = 12 of 30) were confident that APA would reduce and eliminate pain; nonetheless, all participants reported fewer episodes of pain occurrences and pain intensity with the APA treatment. For the participants who completed the 4-week APA protocol (n = 15), 96% (n = 14) decreased analgesic medication intake and 88% (n = 13) felt "much better" after the APA treatment. Participants reported an average reduction of 63% in the worst pain intensity at day 7. By the end of the 4-week APA protocol, an even greater reduction in pain intensity was reported (66%, n = 10, at day 28). The participants who did not complete the treatment protocol reported an average pain reduction of 29%, which fluctuated to 22% before they dropped out. Auricular point acupressure is feasible for patients with chronic pain. The preliminary findings of this feasibility study show a reduction in pain intensity and improvement in physical function, which demonstrate the potential for

  13. Recovery of hand function through mental practice: A study protocol

    PubMed Central

    Ietswaart, Magdalena; Johnston, Marie; Dijkerman, H Chris; Scott, Clare L; Joice, Sara A; Hamilton, Steven; MacWalter, Ronald S

    2006-01-01

    Background The study aims to assess the therapeutic benefits of motor imagery training in stroke patients with persistent motor weakness. There is evidence to suggest that mental rehearsal of movement can produce effects normally attributed to practising the actual movements. Imagining hand movements could stimulate the redistribution of brain activity, which accompanies recovery of hand function, thus resulting in a reduced motor deficit. Methods/Design A multi-centre randomised controlled trial recruiting individuals between one and six months post-stroke (n = 135). Patients are assessed before and after a four-week evaluation period. In this trial, 45 patients daily mentally rehearse movements with their affected arm under close supervision. Their recovery is compared to 45 patients who perform closely supervised non-motor mental rehearsal, and 45 patients who are not engaged in a training program. Motor imagery training effectiveness is evaluated using outcome measures of motor function, psychological processes, and level of disability. Discussion The idea of enhancing motor recovery through the use of motor imagery rehabilitation techniques is important with potential implications for clinical practice. The techniques evaluated as part of this randomised controlled trial are informed by the current understanding in cognitive neuroscience and the trial is both of scientific and applied interest. PMID:17067370

  14. Protocol for evaluation of the cost-effectiveness of ePrescribing systems and candidate prototype for other related health information technologies

    PubMed Central

    2014-01-01

    Background This protocol concerns the assessment of cost-effectiveness of hospital health information technology (HIT) in four hospitals. Two of these hospitals are acquiring ePrescribing systems incorporating extensive decision support, while the other two will implement systems incorporating more basic clinical algorithms. Implementation of an ePrescribing system will have diffuse effects over myriad clinical processes, so the protocol has to deal with a large amount of information collected at various ‘levels’ across the system. Methods/Design The method we propose is use of Bayesian ideas as a philosophical guide. Assessment of cost-effectiveness requires a number of parameters in order to measure incremental cost utility or benefit – the effectiveness of the intervention in reducing frequency of preventable adverse events; utilities for these adverse events; costs of HIT systems; and cost consequences of adverse events averted. There is no single end-point that adequately and unproblematically captures the effectiveness of the intervention; we therefore plan to observe changes in error rates and adverse events in four error categories (death, permanent disability, moderate disability, minimal effect). For each category we will elicit and pool subjective probability densities from experts for reductions in adverse events, resulting from deployment of the intervention in a hospital with extensive decision support. The experts will have been briefed with quantitative and qualitative data from the study and external data sources prior to elicitation. Following this, there will be a process of deliberative dialogues so that experts can “re-calibrate” their subjective probability estimates. The consolidated densities assembled from the repeat elicitation exercise will then be used to populate a health economic model, along with salient utilities. The credible limits from these densities can define thresholds for sensitivity analyses. Discussion The

  15. 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

  16. 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

  17. Depression screening and mental health outcomes in children and adolescents: a systematic review protocol

    PubMed Central

    2012-01-01

    Background Depression is an important cause of disability among children and adolescents. Depression screening is one possible method for managing depression, and screening programs have been initiated in some school and medical settings. However, in 2005, the Canadian Task Force on Preventive Health Care and the United Kingdom National Institute of Clinical Excellence did not recommend depression screening among children and adolescents. By contrast, in 2009, the United States Preventive Services Task Force recommended that all adolescents, but not younger children, be screened for depression in medical settings with integrated depression management services, although no trials of screening were identified. The objectives of this systematic review are to evaluate in children and adolescents the accuracy of depression screening tools; depression treatment efficacy; whether depression screening improves depression outcomes; and potential harms related to depression interventions and screening. Methods/design Data sources will include the bibliographic databases MEDLINE, Cochrane CENTRAL, PsycINFO, EMBASE, LILACS and Web of Science, supplemented by reference harvesting of eligible articles, relevant systematic reviews, relevant guidelines and recommendations, and selected journals, and by searches for unpublished studies. Eligible studies will report data for children and adolescents aged 6 to 18 years. Eligible diagnostic accuracy studies must compare a depression screening tool to a validated diagnostic interview for major depressive disorder and report diagnostic accuracy data. Eligible treatment studies must be randomized controlled trials of pharmacological, psychotherapeutic, or other depression treatments commonly available for children and adolescents in pediatric, primary-care, and family medicine settings. Eligible screening studies must be randomized controlled trials that compare depression outcomes between children or adolescents who underwent depression

  18. 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

  19. 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…

  20. 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

  1. Burden of Obstructive Lung Disease Study in Tehran: Research Design and Lung Spirometry Protocol

    PubMed Central

    Sharifi, Hooman; Masjedi, Mohammad Reza; Emami, Habib; Ghanei, Mostafa; Buist, Sonia

    2014-01-01

    Background: Chronic obstructive pulmonary diseases (COPD) are planned to rank fifth in burden of disease and third with respect to mortality by 2020. Carrying out research regarding different aspects of COPD is mentioned as important health priorities by academic institutions and governments. The burden of lung disease (BOLD) Initiative was designed a decade ago to develop robust models that can be used to estimate the prevalence and current and future economic burden of COPD. The goal of the present project is to describe the prevalence and determining the causes and risk factors of COPD in the population of Tehran city. Methods: This cross-sectional study follows a stratified cluster sampling strategy with proportional allocation within strata. The target population is all noninstitutionalized inhabitants, aged 18-40 in one group and over 40 in another, who inhabit in Tehran city. The stratification of the sample according to the 22 municipal districts of Tehran is incorporated in the sampling process. Proportional to the number of households in the 22 districts, the appropriate number of clusters is weighted according to each district. For each cluster, a team of three members approaches the index household, which is specified through the aforementioned random selection of clusters, and continues the enumeration in 10 neighbor households in a systematic manner. Results: As a study protocol, there are no specific results to present; our purpose is to share our design with the scientific body. Conclusions: We expect that findings from the BOLD study in Tehran will show the status of COPD and its causes in the community. PMID:25538840

  2. 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

  3. 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

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

    PubMed Central

    2014-01-01

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

  5. 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

  6. Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Osteoarthritis (OA) is a common health issue worldwide in the aging population who are also commonly deficient in vitamin D. Our previous study suggested that higher serum 25-(OH)D levels were associated with reduced knee cartilage loss, implying that vitamin D supplementation may prevent the progression of knee OA. The aim of the VItamin D Effects on OA (VIDEO) study is to compare, over a 2- year period, the effects of vitamin D supplementation versus placebo on knee structural changes, knee pain, and lower limb muscle strength in patients with symptomatic knee OA. Methods/design Randomised, placebo-controlled, and double-blind clinical trial aiming to recruit 400 subjects (200 from Tasmania and 200 from Victoria) with both symptomatic knee OA and vitamin D deficiency (serum [25-(OH)D] level of >12.5 nmol/liter and <60 nmol/liter). Participants will be randomly allocated to vitamin D supplementation (50,000 IU compounded vitamin D3 capsule monthly) or identical inert placebo group for 2 years. The primary endpoint is loss of knee cartilage volume measured by magnetic resonance imaging (MRI) and Western Ontario and McMaster Universities Index of OA (WOMAC) knee pain score. The secondary endpoints will be other knee structural changes, and lower limb muscle strength. Several other outcome measures including core muscle images and central blood pressure will be recorded. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modeling analyses. Both intention to treat and per protocol analyses will be utilized. Discussion The trial is designed to test if vitamin D supplementation will reduce loss of knee cartilage volume, prevent the progression of other knee structural abnormalities, reduce knee pain and strengthen lower limb muscle strength, thus modify disease progression in knee OA. Trial registration ClinicalTrials.gov identifier: NCT01176344; Australian New Zealand Clinical Trials

  7. 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

  8. Harmonizing human health studies in the Great Lakes.

    PubMed

    Hicks, H E; Spengler, R F

    1996-01-01

    Epidemiological studies of exposed human populations can provide valuable evidence of human health effects. Information has been sparse on human health effects associated with consumption of contaminated Great Lakes fish. As part of its Great Lakes Human Health Effects Research Program, the Agency for Toxic Substances and Disease Registry (ATSDR) has funded ten projects. Of these studies, eight are epidemiologic investigations of human exposure and potential health effects from consumption of contaminated fish. To strengthen and to enhance the findings and comparability across the health studies, ATSDR has initiated several activities. These activities include harmonizing questionnaires, analytical protocols, human health end points, and contaminants tested. Also included is the establishment of a quality assurance and quality control (QA/QC) program and tissue bank. These activities will allow ATSDR to enhance exposure assessment in the Great Lakes basin. In addition, these research activities allow ATSDR to evaluate and to interpret data across all the projects, including a basin-wide health risk analysis on exposure, levels of contaminants or body burden, and the potential for human health effects from exposure to Great Lakes contaminants. PMID:8843563

  9. 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.

  10. 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

  11. 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

  12. 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

  13. [DHS: The Dortmund health study].

    PubMed

    Berger, K

    2012-06-01

    The aim of the population-based Dortmund health study (DHS) is the assessment of the prevalence and incidence of different headache types as well as other chronic conditions and to analyse their consequences on daily activities of those affected. From 2003 to 2004 overall 2,291 participants were recruited into the study, 1,312 attended the study centre and the others participated by answering a mailed questionnaire. In 2006 a follow-up by mailed questionnaire was performed for 77.8% of the survivors. The influence of social factors was specifically considered in the analysis and interpretation of disease consequences. The following manuscript describes the study design, method of participant recruitment, data assessment and examinations performed in the study and reports the results of the association between neighbourhood unemployment and the prevalence of cardiac risk factors as well as the prevalence of several chronic diseases. PMID:22736161

  14. Evaluating newly acquired authority of nurse practitioners and physician assistants for reserved medical procedures in the Netherlands: a study protocol

    PubMed Central

    De Bruijn-Geraets, Daisy P; Van Eijk-Hustings, Yvonne JL; Vrijhoef, Hubertus JM

    2014-01-01

    Aim The study protocol is designed to evaluate the effects of granting independent authorization for medical procedures to nurse practitioners and physician assistants on processes and outcomes of health care. Background Recent (temporarily) enacted legislation in Dutch health care authorizes nurse practitioners and physician assistants to indicate and perform specified medical procedures, i.e. catheterization, cardioversion, defibrillation, endoscopy, injection, puncture, prescribing and simple surgical procedures, independently. Formerly, these procedures were exclusively reserved to physicians, dentists and midwives. Design A triangulation mixed method design is used to collect quantitative (surveys) and qualitative (interviews) data. Methods Outcomes are selected from evidence-based frameworks and models for assessing the impact of advanced nursing on quality of health care. Data are collected in various manners. Surveys are structured around the domains: (i) quality of care; (ii) costs; (iii) healthcare resource use; and (iv) patient centredness. Focus group and expert interviews aim to ascertain facilitators and barriers to the implementation process. Data are collected before the amendment of the law, 1 and 2·5 years thereafter. Groups of patients, nurse practitioners, physician assistants, supervising physicians and policy makers all participate in this national study. The study is supported by a grant from the Dutch Ministry of Health, Welfare and Sport in March 2011. Research Ethics Committee approval was obtained in July 2011. Conclusion This study will provide information about the effects of granting independent authorization for medical procedures to nurse practitioners and physician assistants on processes and outcomes of health care. Study findings aim to support policy makers and other stakeholders in making related decisions. The study design enables a cross-national comparative analysis. PMID:24684631

  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. An observational, longitudinal study on the home environment of people with chronic obstructive pulmonary disease: the research protocol of the Home Sweet Home study

    PubMed Central

    Nakken, Nienke; Janssen, Daisy J A; van den Bogaart, Esther H A; Vercoulen, Jan H; Wouters, Emiel F M; Spruit, Martijn A

    2014-01-01

    Introduction Chronic obstructive pulmonary disease (COPD) represents an important public health challenge. Patients are confronted with limitations during activities of daily living (ADLs). Resident loved ones of patients with COPD may be uniquely positioned to witness these limitations. COPD may have an impact on not only the patients’ life, but also on the lives of the resident loved ones. Furthermore, COPD exacerbation-related hospital admissions often occur in patients with COPD. However, whether and to what extent these admissions influence resident loved ones’ burden and health status remains currently unknown. Therefore, the primary objectives of this study are to investigate the differences between patients with COPD and resident loved ones’ perceptions of patients’ health status and problematic ADLs and to study prospectively the effects of a COPD exacerbation on resident loved ones’ perceptions of patients’ health status and problematic ADLs. Methods and analysis An observational, longitudinal study will be performed in 192 patients with COPD and their 192 resident loved ones. Primary outcomes are daily functioning, ADL, disease-specific health status, generic health status and dyspnoea. These will be assessed during home visits at baseline and after 12 months. Additional home visits will be performed when a COPD exacerbation-related hospital admission occurs during the 12-month follow-up period. Ethics and dissemination This protocol was approved by the Medical Ethics Committee of the Catharina Hospital Eindhoven, the Netherlands (NL42721.060.12/M12-1280) and is registered in the Dutch Trial Register (NTR3941). PMID:25384686

  17. Procedures for the ethical review of public health surveillance protocols. Commentary.

    PubMed

    Petrini, Carlo

    2014-01-01

    The present commentary is based on the following considerations: 1) for the purposes of authorisation, a distinction is drawn between "research" and "intervention". The procedures for authorising the former are more complex, the relevant controls are stricter and approval has to be granted by a Research Ethics Committee (REC); 2) although the debate is still open, it is barely credible to claim that public health surveillance is not a form of research. It should, therefore, be subject to rigorous ethical assessment; 3) when addressing specifically the issue of surveillance, it would be appropriate to shift the focus of attention from the type of procedure (research/intervention) to the risk implied in that procedure; 4) much emphasis has hitherto been placed on the risks that public health surveillance may imply for the protection of personal data; 5) the emphasis on the protection of personal data is frequently excessive and the risks should be examined in a broader context. PMID:24695246

  18. 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

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

    PubMed

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

    2013-01-01

    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

  20. Health communication in primary health care -A case study of ICT development for health promotion

    PubMed Central

    2013-01-01

    Background Developing Information and Communication Technology (ICT) supported health communication in PHC could contribute to increased health literacy and empowerment, which are foundations for enabling people to increase control over their health, as a way to reduce increasing lifestyle related ill health. However, to increase the likelihood of success of implementing ICT supported health communication, it is essential to conduct a detailed analysis of the setting and context prior to the intervention. The aim of this study was to gain a better understanding of health communication for health promotion in PHC with emphasis on the implications for a planned ICT supported interactive health channel. Methods A qualitative case study, with a multi-methods approach was applied. Field notes, document study and focus groups were used for data collection. Data was then analyzed using qualitative content analysis. Results Health communication is an integral part of health promotion practice in PHC in this case study. However, there was a lack of consensus among health professionals on what a health promotion approach was, causing discrepancy in approaches and practices of health communication. Two themes emerged from the data analysis: Communicating health and environment for health communication. The themes represented individual and organizational factors that affected health communication practice in PHC and thus need to be taken into consideration in the development of the planned health channel. Conclusions Health communication practiced in PHC is individual based, preventive and reactive in nature, as opposed to population based, promotive and proactive in line with a health promotion approach. The most significant challenge in developing an ICT supported health communication channel for health promotion identified in this study, is profiling a health promotion approach in PHC. Addressing health promotion values and principles in the design of ICT supported health

  1. Cameras for Public Health Surveillance: A Methods Protocol for Crowdsourced Annotation of Point-of-Sale Photographs

    PubMed Central

    Tacelosky, Michael; Ivey, Keith C; Pearson, Jennifer L; Cantrell, Jennifer; Vallone, Donna M; Abrams, David B; Kirchner, Thomas R

    2014-01-01

    Background Photographs are an effective way to collect detailed and objective information about the environment, particularly for public health surveillance. However, accurately and reliably annotating (ie, extracting information from) photographs remains difficult, a critical bottleneck inhibiting the use of photographs for systematic surveillance. The advent of distributed human computation (ie, crowdsourcing) platforms represents a veritable breakthrough, making it possible for the first time to accurately, quickly, and repeatedly annotate photos at relatively low cost. Objective This paper describes a methods protocol, using photographs from point-of-sale surveillance studies in the field of tobacco control to demonstrate the development and testing of custom-built tools that can greatly enhance the quality of crowdsourced annotation. Methods Enhancing the quality of crowdsourced photo annotation requires a number of approaches and tools. The crowdsourced photo annotation process is greatly simplified by decomposing the overall process into smaller tasks, which improves accuracy and speed and enables adaptive processing, in which irrelevant data is filtered out and more difficult targets receive increased scrutiny. Additionally, zoom tools enable users to see details within photographs and crop tools highlight where within an image a specific object of interest is found, generating a set of photographs that answer specific questions. Beyond such tools, optimizing the number of raters (ie, crowd size) for accuracy and reliability is an important facet of crowdsourced photo annotation. This can be determined in a systematic manner based on the difficulty of the task and the desired level of accuracy, using receiver operating characteristic (ROC) analyses. Usability tests of the zoom and crop tool suggest that these tools significantly improve annotation accuracy. The tests asked raters to extract data from photographs, not for the purposes of assessing the

  2. Instruments to measure patient experience of health care quality in hospitals: a systematic review protocol

    PubMed Central

    2014-01-01

    Background Improving and sustaining the quality of care in hospitals is an intractable and persistent challenge. The patients’ experience of the quality of hospital care can provide insightful feedback to enable clinical teams to direct quality improvement efforts in areas where they are most needed. Yet, patient experience is often marginalised in favour of aspects of care that are easier to quantify (for example, waiting time). Attempts to measure patient experience have been hindered by a proliferation of instruments using various outcome measures with varying degrees of psychometric development and testing. Methods/Design We will conduct a systematic review and utility critique of instruments used to measure patient experience of health care quality in hospitals. The databases Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Psychological Information (Psych Info) and Web of Knowledge will be searched from inception until end November 2013. Search strategies will include the key words; patient, adult, hospital, secondary care, questionnaires, instruments, health care surveys, experience, satisfaction and patient opinion in various combinations. We will contact experts in the field of measuring patient experience and scrutinise all secondary references. A reviewer will apply an inclusion criteria scale to all titles and abstracts. A second reviewer will apply the inclusion criteria scale to a random 10% selection. Two reviewers will independently evaluate the methodological rigour of the testing of the instruments using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist. Disagreements will be resolved through consensus. Instruments will be critiqued and grouped using van der Vleuten’s utility index. We will present a narrative synthesis on the utility of all instruments and make recommendations for instrument selection in

  3. A protocol design for studying alterations of pharmacokinetic parameters due to pregnancy.

    PubMed

    Philipson, A

    1980-01-01

    A study protocol is described by means of which useful and pertinent information on possible alterations of pharmacokinetic parameters due to pregnancy can be investigated. Whenever any drug is prescribed to a pregnant woman for medical reasons, pharmacokinetic data for that drug can be obtained by determination of drug levels in urine, plasma or serum, or other possible tissues. The same data should later be obtained for an identical dose of the same drug given to the same woman after pregnancy. By comparing pharmacokinetic parameters in the same woman during pregnancy and after--when she serves as her own nonpregnant control--clinically and statistically significant differences may be discovered with a comparatively small patient material. As in each case the drug that is studied is prescribed for medical reasons, this protocol involves no undue risks for the pregnant woman or the fetus. PMID:7445992

  4. 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

  5. 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

  6. Hodgkin's lymphoma in adolescents treated with adult protocols: a report from the German Hodgkin study group.

    PubMed

    Eichenauer, Dennis A; Bredenfeld, Henning; Haverkamp, Heinz; Müller, Horst; Franklin, Jeremy; Fuchs, Michael; Borchmann, Peter; Müller-Hermelink, Hans-Konrad; Eich, Hans T; Müller, Rolf-Peter; Diehl, Volker; Engert, Andreas

    2009-12-20

    PURPOSE The standard of care for adolescent patients with Hodgkin's lymphoma (HL) is undefined, particularly the choice between pediatric and adult protocols. Thus, we compared risk factors and outcome of adolescents and young adults treated within study protocols of the German Hodgkin Study Group (GHSG). PATIENTS AND METHODS Three thousand seven hundred eighty-five patients treated within the GHSG studies HD4 to HD9 were analyzed; 557 patients were adolescents age 15 to 20 years, and 3,228 patients were young adults age 21 to 45 years. Results Large mediastinal mass and involvement of three or more lymph node areas were more frequent in adolescents (P < .001). The incidence of other risk factors did not differ significantly between age groups. With a median observation time of 81 months for freedom from treatment failure (FFTF) and 85 months for overall survival (OS), log-rank test showed no significant differences between age groups regarding FFTF (P = .305) and a superior OS (P = .008) for adolescents. Six-year estimates for FFTF and OS were 80% and 94%, respectively, for adolescents and 80% and 91%, respectively, for young adults. After adjustment for other predictive factors, Cox regression analysis revealed age as a significant predictor for OS (P = .004), with a higher mortality risk for young adults. Secondary malignancies were more common in young adults (P = .037). CONCLUSION Outcome of adolescent and young adult patients treated within GHSG study protocols is comparable. These data suggest that adult treatment protocols exhibit a safe and effective treatment option for adolescent patients with HL. However, longer follow-up, including assessment of late toxicity, is necessary for final conclusions. PMID:19901121

  7. 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

  8. Creating a Community of Inquiry in Online Environments: An Exploratory Study on the Effect of a Protocol on Interactions within Asynchronous Discussions

    ERIC Educational Resources Information Center

    Zydney, Janet Mannheimer; deNoyelles, Aimee; Seo, Kay Kyeong-Ju

    2012-01-01

    The purpose of our research was to examine the influence of an online protocol on asynchronous discussions. A mixed-methods study compared two online graduate classes: one that used a protocol and one that did not use a protocol for the same discussion about a complex reading. Analysis of the data revealed that the online protocol more evenly…

  9. 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

  10. 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

  11. 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

  12. 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

  13. Development of implant loading device for animal study about various loading protocol: a pilot study

    PubMed Central

    Yoon, Joon-Ho; Park, Young-Bum; Cho, Yuna; Kim, Chang-Sung; Choi, Seong-Ho; Moon, Hong-Seok; Lee, Keun-Woo

    2012-01-01

    PURPOSE The aims of this pilot study were to introduce implant loading devices designed for animal study and to evaluate the validity of the load transmission ability of the loading devices. MATERIALS AND METHODS Implant loading devices were specially designed and fabricated with two implant abutments and cast metal bars, and orthodontic expansion screw. In six Beagles, all premolars were extracted and two implants were placed in each side of the mandibles. The loading device was inserted two weeks after the implant placement. According to the loading protocol, the load was applied to the implants with different time and method,simulating early, progressive, and delayed loading. The implants were clinically evaluated and the loading devices were removed and replaced to the master cast, followed by stress-strain analysis. Descriptive statistics of remained strain (µε) was evaluated after repeating three cycles of the loading device activation. Statistic analysis was performed using nonparametric, independent t-test with 5% significance level and Friedman's test was also used for verification. RESULTS The loading devices were in good action. However, four implants in three Beagles showed loss of osseointegration. In stress-strain analysis, loading devices showed similar amount of increase in the remained strain after applying 1-unit load for three times. CONCLUSION Specialized design of the implant loading device was introduced. The loading device applied similar amount of loads near the implant after each 1-unit loading. However, the direction of the loads was not parallel to the long axis of the implants as predicted before the study. PMID:23236575

  14. ADDHEALTH - NATIONAL LONGITUDINAL STUDY OF ADOLESCENT HEALTH

    EPA Science Inventory

    This study provides a comprehensive view of the health and health behaviors of adolescents and the antecedents - personal, interpersonal, familial, and environmental of these outcomes. The study features a longitudinal, multi-level design with independent measurement at the indiv...

  15. Tailoring Protocols to Successfully Recruit and Retain Elders in a Longitudinal Study of Sleep and Cognition

    PubMed Central

    Carlson, John R.; Neelon, Virginia J.; Hartman, Marilyn

    2012-01-01

    Many studies attest to the challenges of recruiting and retaining older adults in longitudinal studies. This article presents the methods used by the Physiological Research to Improve Sleep and Memory Project to recruit and retain 115 adults (70+ years) in a 2-year study that involved yearly administrations of two neurocognitive test batteries and two nights of polysomnography. The paper describes strategies which are built on knowledge obtained from participant informants and the use of tailored, individualize protocols. Together, these strategies enabled participants to become vested in the research process and to fully participate in all aspects of the study. PMID:20077997

  16. 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:…

  17. A Protocol to Collect Specific Mouse Skeletal Muscles for Metabolomics Studies.

    PubMed

    Gan, Zhuohui; Fu, Zhenxing; Stowe, Jennifer C; Powell, Frank L; McCulloch, Andrew D

    2016-01-01

    Due to the highly sensitive nature of metabolic states, the quality of metabolomics data depends on the suitability of the experimental procedure. Metabolism could be affected by factors such as the method of euthanasia of the animals and the sample collection procedures. The effects of these factors on metabolites are tissue-specific. Thus, it is important to select proper methods to sacrifice the animal and appropriate procedures for collecting samples specific to the tissue of interest. Here, we present our protocol to collect specific mouse skeletal muscles with different fiber types for metabolomics studies. We also provide a protocol to measure lactate levels in tissue samples as a way to estimate the metabolic state in collected samples. PMID:26003134

  18. 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

  19. 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

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

    PubMed Central

    2011-01-01

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

  1. 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

  2. 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)

  3. A study into salivary-based measurement of human stress subjected to Ellestad stress test protocol.

    PubMed

    Lee, Y K; Za'aba, A; Madzhi, N K; Ahmad, A

    2009-01-01

    Previous works on the effects of salivary alpha amylase in respond to various stressors report encouraging findings on it being a good indicator of stress. Ellestad protocol is a clinical procedure to screen for coronary artery disease by introducing exercise induced physical stress. If a salivary based biomarker profile in accordance to a stress test protocol could be established, the critical stress state which disable rational decision making could be ascertained in a standardized procedure. This technique would serve to aid human resource management in times of critical events such as rescue, firefighting or even military, that would potentially prevent unnecessary sacrifice of human lives. In this pilot study with five healthy volunteers performing the Ellestad protocol treadmill, a measurement profile with physiologic and salivary based biomarker is obtained. It is found that the alpha amylase levels or the changes in it as workload changes from resting-walking-running at ease-exhaustive running, is relatively more significant in reflecting the stress state than heart rate and blood pressure. Moreover, it is strongly associated with mood state with correlation coefficient of 0.8 and significance of 0.01. PMID:19964239

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

    PubMed Central

    Yildirim, Gülsün; Ataoglu, Hanife; Kalayci, Abdullah; Kucuk, Korhan; Esen, Alparslan

    2010-01-01

    ABSTRACT Background The keratocystic odontogenic tumour is classified as a developmental cyst derived from the enamel organ or from the dental lamina. The treatment of keratocystic odontogenic tumour of the jaw remains controversial. The aim of this study was to report the outcome of our conservative treatment protocol for keratocystic odontogenic tumour. Methods Three patients with different complaints referred to Oral and Maxillofacial Surgery Clinic, Faculty of Dentistry, Selçuk University. Initial biopsy was carried out in all patients and keratocystic odontogenic tumours was diagnosed subsequent to histopathological examination. The patients with keratocystic odontogenic tumours were treated by enucleation followed by open packing. This conservative treatment protocol was selected because of existing young aged patients. The average follow-up duration of the cases was 2 years. Results Out of 3 cases, 2 lesions were present in mandible and 1 lesion in maxilla. There was no evidence of recurrence during follow-up. All the cases were monitored continuously with panoramic radiographs, computed tomography and clinical evaluations. Conclusions This conservative treatment protocol for keratocystic odontogenic tumours, based on enucleation followed by open packing would be a possible choice with a view of offering low recurrence rate and low morbidity rate particularly in young patients. PMID:24421977

  5. 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

  6. 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

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

    PubMed

    Edwards, David J; Love, Peter E D

    2016-08-01

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

  8. 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

  9. 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

  10. 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

  11. Transmission electron microscopy sample preparation protocols for the ultrastructural study of cysts of free-living protozoa.

    PubMed

    Lambrecht, Ellen; Baré, Julie; Claeys, Myriam; Chavatte, Natascha; Bert, Wim; Sabbe, Koen; Houf, Kurt

    2015-04-01

    Cysts of free-living protozoa have an impact on the ecology and epidemiology of bacteria because they may act as a transmission vector or shelter the bacteria against hash environmental conditions. Detection and localization of intracystic bacteria and examination of the en- and excystment dynamics is a major challenge because no detailed protocols for ultrastructural analysis of cysts are currently available. Transmission electron microscopy (TEM) is ideally suited for those analyses; however, conventional TEM protocols are not satisfactory for cysts of free-living protozoa. Here we report on the design and testing of four protocols for TEM sample preparation of cysts. Two protocols, one based on chemical fixation in coated well plates and one on high-pressure freezing, were selected as the most effective for TEM-based ultrastructural studies of cysts. Our protocols will enable improved analysis of cyst structure and a better understanding of bacterial survival mechanisms in cysts. PMID:25861930

  12. 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…

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

  18. Optimizing the swallow protocol of clinical high resolution esophageal manometry studies

    PubMed Central

    Xiao, Yinglian; Nicodème, Frédéric; Kahrilas, Peter J.; Roman, Sabine; Lin, Zhiyue; Pandolfino, John E.

    2013-01-01

    Background The Chicago Classification of Esophageal Motility Disorders (CC) is based on 10 water swallows performed in the supine position. The aim of the study was to assess whether upright and provocative swallows provided important information beyond that obtained from the standard supine manometric protocol. Methods Two independent investigators reviewed high resolution manometry (HRM) studies of 148 patients with both supine and upright liquid swallows and additional studies from patients with provocative swallows (increased volume, viscosity, and a marshmallow) for a resultant change in CC diagnoses. Significant diagnostic changes were defined as a change from normal or borderline motor function to abnormal motor function, EGJ outflow obstruction or achalasia. Discordant diagnoses were reviewed and the Kappa test was used to evaluate the agreement between diagnoses in the different protocols. Key Results The overall agreement in diagnosis between the 5 supine swallows and the 5 upright swallows was good (k=0.583). Changing to the upright position elicited a significant diagnostic change in 10.1% (15/148) of cases. The provocative swallows suggested an alternative diagnosis from the supine position in 14 of 75 studies (18.7%); 11 of these changed to EGJ obstruction during viscous or solid bolus challenges. Conclusion Changing position in HRM elicited a significant change in diagnosis in about 10% of studies while provocative bolus challenges with viscous liquid and marshmallows increased the detection of EGJ outflow obstruction. Performing manometric evaluations in both positions with provocative swallows may increase the yield of standard HRM technique. PMID:22863083

  19. 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

  20. Visual acuity testability of children in Bama and Banki towns of Borno State, Nigeria: The need to adopt HOTV protocol in school health programmes

    PubMed Central

    Delia, Tumba; Adamu, Adiel A.; Ngilari, Usiju M.

    2012-01-01

    Despite the importance of visual acuity testing in children, no standard testing protocol was found for primary school pupils. Visual acuity screening was conducted on 400 primary school pupils in Nigeria using the HOTV protocol, nearly all the pupils 390/400 (97.5 %) had good binocular vision, only 10/400 (2.5 %) had poor vision which were monocular. Of those with poor monocular vision, 6/10 (60 %) involved the right eye while 4/10 (40 %) the left eye; these pupils were referred to the ophthalmologist for further evaluation. Because of its easy usage, the HOTV protocol can be adopted by school health programmes especially for the primary school pupils.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

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

    PubMed Central

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

    2015-01-01

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

  7. 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

  8. 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

  9. 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

  10. The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol.

    PubMed

    Vestbo, Jørgen; Anderson, Julie; Brook, Robert D; Calverley, Peter M A; Celli, Bartolome R; Crim, Courtney; Haumann, Brett; Martinez, Fernando J; Yates, Julie; Newby, David E

    2013-05-01

    Chronic obstructive pulmonary disease (COPD) often coexists with other chronic diseases and comorbidities that can markedly influence patients' health status and prognosis. This is particularly true for cardiovascular disease (CVD). However, there have been no trials assessing the effect of COPD medications on CVD in patients with both diseases. The "Study to Understand Mortality and Morbidity in COPD" (SUMMIT) aims at determining the impact of fluticasone furoate/vilanterol combination and the individual components on the survival of patients with moderate COPD and either a history of CVD or at increased risk for CVD. SUMMIT is a multicentre, randomised, double-blind, parallel-group, placebo-controlled trial of 16 000 patients with moderate COPD randomly assigned to once daily treatment with fluticasone furoate/vilanterol (100/25 μg), fluticasone furoate (100 μg), vilanterol (25 μg) or matched placebo; mortality is the primary end-point. The study is an event-driven trial powered by the comparison of furoate/vilanterol versus placebo. Secondary end-points are decline in forced expiratory volume in 1 s and effect on a composite cardiovascular end-point. This article describes the design of the SUMMIT study. PMID:23018908

  11. 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

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

    PubMed

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

    2016-03-01

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

  13. 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

  14. Study Protocol: The Behaviour and Pain in Dementia Study (BePAID)

    PubMed Central

    2011-01-01

    Background People with dementia admitted to the acute hospital often receive poor quality care particularly with regards to management of behavioural and psychiatric symptoms of dementia (BPSD) and of pain. There have been no UK studies on the prevalence and type of pain or BPSD in people with dementia in this setting, or on how these may impact on patients, carers, staff and costs of care. Methods/Design We shall recruit older people with dementia who have unplanned acute medical admissions and measure the prevalence of BPSD using the Behave-AD (Behaviour in Alzheimer's Disease) and the CMAI (Cohen Mansfield Agitation Inventory). Pain prevalence and severity will be assessed by the PAINAD (Pain Assessment in Advanced Dementia) and the FACES pain scale. We will then analyse how these impact on a variety of outcomes and test the hypothesis that poor management of pain is associated with worsening of BPSD. Discussion By demonstrating the costs of BPSD to individuals with dementia and the health service this study will provide important evidence to drive improvements in care. We can then develop effective training for acute hospital staff and alternative treatment strategies for BPSD in this setting. PMID:22004045

  15. HEART: heart exercise and remote technologies: A randomized controlled trial study protocol

    PubMed Central

    2011-01-01

    Background Cardiovascular disease (CVD) is the leading cause of death worldwide. Cardiac rehabilitation (CR) is aimed at improving health behaviors to slow or reverse the progression of CVD disease. Exercise is a central element of CR. Technologies such as mobile phones and the Internet (mHealth) offer potential to overcome many of the psychological, physical, and geographical barriers that have been associated with lack of participation in exercise-based CR. We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD. This paper outlines the rationale and methods of the trial. Methods A single-blinded parallel two-arm randomized controlled trial is being conducted. A total of 170 people will be randomized at 1:1 ratio either to receive a mHealth CR program or usual care. Participants are identified by CR nurses from two metropolitan hospitals in Auckland, New Zealand through outpatient clinics and existing databases. Consenting participants are contacted to attend a baseline assessment. The intervention consists of a theory-based, personalized, automated package of text and video message components via participants' mobile phones and the Internet to increase exercise behavior, delivered over six months. The control group will continue with usual CR. Data collection occurs at baseline and 24 weeks (post-intervention). The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks. Secondary outcomes include post-intervention measures on self-reported physical activity (IPAQ), cardiovascular risk factors (systolic blood pressure, weight, and waist to hip ratio), health related quality of life (SF-36), and cost-effectiveness. Discussion This manuscript presents the protocol for a randomized controlled trial of a mHealth exercise-based CR program. Results of this trial will provide much needed information about physical and

  16. The Learning About My Pain study protocol: Reducing disparities with literacy-adapted psychosocial treatments for chronic pain, a comparative behavioral trial.

    PubMed

    Eyer, Joshua C; Thorn, Beverly E

    2016-09-01

    Chronic pain is a critical public health problem that affects over 100 million Americans. Medical pain treatments carry undesirable side effects, whereas low-risk psychosocial treatments offer notable benefits, in combination or in isolation. This report presents the protocol for the Learning About My Pain study, one of the first comparative-effectiveness trials funded by the Patient-Centered Outcomes Research Institute. Adhering to published standards for clinical trials (e.g. Standard Protocol Items: Recommendations for Intervention Trials), it provides an overview of the trial (n = 294), comparing cognitive-behavioral and education pain interventions to usual care, and a detailed description of how its methodology reduces the risks from bias. PMID:25712491

  17. 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

  18. 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

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

    PubMed

    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

  20. 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