Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation.

PubMed

Dewitt, James; Capistrant, Benjamin; Kohli, Nidhi; Rosser, B R Simon; Mitteldorf, Darryl; Merengwa, Enyinnaya; West, William

2018-04-24

While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. This paper reports the challenges of survey validation inherent in a small Web-based health survey research. The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed. ©James Dewitt, Benjamin Capistrant, Nidhi Kohli, B R Simon Rosser, Darryl Mitteldorf, Enyinnaya Merengwa, William West. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.04.2018.

Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation

PubMed Central

Dewitt, James; Capistrant, Benjamin; Kohli, Nidhi; Mitteldorf, Darryl; Merengwa, Enyinnaya; West, William

2018-01-01

Background While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. Objective This paper reports the challenges of survey validation inherent in a small Web-based health survey research. Methods The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Results Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Conclusions Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed. PMID:29691203

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

PubMed

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

2012-08-27

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

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

PubMed

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.

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

PubMed Central

2011-01-01

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

Built to last? The sustainability of health system improvements, interventions and change strategies: a study protocol for a systematic review

PubMed Central

Braithwaite, Jeffrey; Testa, Luke; Lamprell, Gina; Herkes, Jessica; Ludlow, Kristiana; McPherson, Elise; Campbell, Margie; Holt, Joanna

2017-01-01

Introduction The sustainability of healthcare interventions and change programmes is of increasing importance to researchers and healthcare stakeholders interested in creating sustainable health systems to cope with mounting stressors. The aim of this protocol is to extend earlier work and describe a systematic review to identify, synthesise and draw meaning from studies published within the last 5 years that measure the sustainability of interventions, improvement efforts and change strategies in the health system. Methods and analysis The protocol outlines a method by which to execute a rigorous systematic review. The design includes applying primary and secondary data collection techniques, consisting of a comprehensive database search complemented by contact with experts, and searching secondary databases and reference lists, using snowballing techniques. The review and analysis process will occur via an abstract review followed by a full-text screening process. The inclusion criteria include English-language, peer-reviewed, primary, empirical research articles published after 2011 in scholarly journals, for which the full text is available. No restrictions on location will be applied. The review that results from this protocol will synthesise and compare characteristics of the included studies. Ultimately, it is intended that this will help make it easier to identify and design sustainable interventions, improvement efforts and change strategies. Ethics and dissemination As no primary data were collected, ethical approval was not required. Results will be disseminated in conference presentations, peer-reviewed publications and among policymaker bodies interested in creating sustainable health systems. PMID:29133332

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

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

PubMed

Gamboa Delgado, Edna M; Rojas Sánchez, Lyda Z; Bermon Angarita, Anderson; Rangel Díaz, Yully Andrea; Jaraba Suárez, Silvia J; Serrano Díaz, Norma C; Vega Fernández, Evaristo

2015-07-30

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

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

[The intervention mapping protocol: A structured process to develop, implement and evaluate health promotion programs].

PubMed

Fassier, J-B; Lamort-Bouché, M; Sarnin, P; Durif-Bruckert, C; Péron, J; Letrilliart, L; Durand, M-J

2016-02-01

Health promotion programs are expected to improve population health and reduce social inequalities in health. However, their theoretical foundations are frequently ill-defined, and their implementation faces many obstacles. The aim of this article is to describe the intervention mapping protocol in health promotion programs planning, used recently in several countries. The challenges of planning health promotion programs are presented, and the six steps of the intervention mapping protocol are described with an example. Based on a literature review, the use of this protocol, its requirements and potential limitations are discussed. The intervention mapping protocol has four essential characteristics: an ecological perspective (person-environment), a participative approach, the use of theoretical models in human and social sciences and the use of scientific evidence. It comprises six steps: conduct a health needs assessment, define change objectives, select theory-based change techniques and practical applications, organize techniques and applications into an intervention program (logic model), plan for program adoption, implementation, and sustainability, and generate an evaluation plan. This protocol was used in different countries and domains such as obesity, tobacco, physical activity, cancer and occupational health. Although its utilization requires resources and a critical stance, this protocol was used to develop interventions which efficacy was demonstrated. The intervention mapping protocol is an integrated process that fits the scientific and practical challenges of health promotion. It could be tested in France as it was used in other countries, in particular to reduce social inequalities in health. Copyright © 2016. Published by Elsevier Masson SAS.

Can action research strengthen district health management and improve health workforce performance? A research protocol.

PubMed

Mshelia, C; Huss, R; Mirzoev, T; Elsey, H; Baine, S O; Aikins, M; Kamuzora, P; Bosch-Capblanch, X; Raven, J; Wyss, K; Green, A; Martineau, T

2013-08-30

The single biggest barrier for countries in sub-Saharan Africa (SSA) to scale up the necessary health services for addressing the three health-related Millennium Development Goals and achieving Universal Health Coverage is the lack of an adequate and well-performing health workforce. This deficit needs to be addressed both by training more new health personnel and by improving the performance of the existing and future health workforce. However, efforts have mostly been focused on training new staff and less on improving the performance of the existing health workforce. The purpose of this paper is to disseminate the protocol for the PERFORM project and reflect on the key challenges encountered during the development of this methodology and how they are being overcome. The overall aim of the PERFORM project is to identify ways of strengthening district management in order to address health workforce inadequacies by improving health workforce performance in SSA. The study will take place in three districts each in Ghana, Tanzania and Uganda using an action research approach. With the support of the country research teams, the district health management teams (DHMTs) will lead on planning, implementation, observation, reflection and redefinition of the activities in the study. Taking into account the national and local human resource (HR) and health systems (HS) policies and practices already in place, 'bundles' of HR/HS strategies that are feasible within the context and affordable within the districts' budget will be developed by the DHMTs to strengthen priority areas of health workforce performance. A comparative analysis of the findings from the three districts in each country will add new knowledge on the effects of these HR/HS bundles on DHMT management and workforce performance and the impact of an action research approach on improving the effectiveness of the DHMTs in implementing these interventions. Different challenges were faced during the development of

Merging video coaching and an anthropologic approach to understand health care provider behavior toward hand hygiene protocols.

PubMed

Boudjema, Sophia; Tarantini, Clément; Peretti-Watel, Patrick; Brouqui, Philippe

2017-05-01

We used videorecordings of routine care to analyze health care providers' deviance from protocols and organized follow-up interviews that were conducted by an anthropologist and a nurse. After consent, health care workers were recorded during routine care by an automatic video remote control. Each participant was invited to watch her or his recorded behaviors on 2 different videos showing routine practices and her or his deviance from protocols, and to comment on them. After this step an in-depth interview based on preestablished guidelines was organized and explanations regarding the observed deviance was discussed. This design was intended to reveal the HCWs' subjectivity; that is, how they perceive hand hygiene issues in their daily routine, what concrete difficulties they face, and how they try to resolve them. We selected 43 of 250 videorecordings created during the study, which allowed us to study 15 out of 20 health care professionals. Twenty out of 43 videos showed 1 or more breaches in the hand hygiene protocol. The breaches were frequently linked to glove abuse. Deviance from protocols was explained by the health care workers as the result of an adaptive behavior; that is, facing work constraints that were disconnected from infection control protocols. Professional practices and protocols should be revisited to create simple messages that are adapted to the mandatory needs in a real life clinic environment. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Bioindicators in the MIDUS National Study: Protocol, Measures, Sample, and Comparative Context

PubMed Central

Love, Gayle Dienberg; Seeman, Teresa E.; Weinstein, Maxine; Ryff, Carol D.

2010-01-01

Objectives MIDUS is a national study of health and aging among individuals aged 25 to 74 at baseline(1995/96). Longitudinal survey assessments (2004/05), were followed by biological assessments on a subsample aged 35–85. To facilitate public use, we describe the protocol, measures, and sample. Methods Respondents traveled to clinics for a two-day data collection protocol that included fasting blood specimens, 12-hour urine specimen, medical history, physical exam, bone densitometry, a laboratory challenge (heart rate variability, blood pressure, respiration, salivary cortisol). Results Response rates for the biological protocol (N = 1,255) were 39.3%, or 43.1% (adjusting for those who could not be located or contacted). Reasons for non-participation were travel, family obligations, and being too busy. Respondents were comparable to the recruitment pool on most demographic characteristics and health assessments. Discussion Strengths of the protocol vis-à-vis other similar studies include opportunities to link biological factors with diverse content from other MIDUS projects. PMID:20876364

The impact of cash transfers on social determinants of health and health inequalities in Sub-Saharan Africa: a systematic review protocol.

PubMed

Owusu-Addo, Ebenezer; Renzaho, Andre M N; Mahal, Ajay S; Smith, Ben J

2016-07-13

There is increasing pressure to address the social determinants of health (SDoH) and health inequities through the implementation of culturally acceptable interventions particularly in Sub-Saharan Africa (SSA) where health outcomes are generally poor. Available evaluation research on cash transfers (CTs) suggests that the programs may influence the wider determinants of health in SSA; yet, there has been no attempt to synthesize the evidence regarding their contribution to tackling the SDoH and health inequalities. To date, nearly all the reviews on CTs' impact on health have predominantly featured evidence from Latin America with limited transferability to the social, cultural, and political environments in SSA. Therefore, the aim of this study is to undertake a systematic review to assess the role of CTs in tackling the wider determinants of health and health inequalities in SSA. A systematic review of published and unpublished literature on CTs' impact on health and health determinants covering the period 2000-2016 will be undertaken. Studies will be considered for inclusion if they present quantitative or qualitative data, including all relevant study designs. The SDoH conceptual framework will be used to guide the data extraction process. EPPI Reviewer software will be used for data management and analysis. Studies included in the review will be analyzed by narrative synthesis and/or meta-analysis as appropriate for the nature of the data retrieved. This review will provide empirical evidence on the impact of CTs on SDoH to inform CT policy, implementation, and research in SSA. The protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). This protocol has been registered with the PROSPERO international prospective register of systematic reviews, reference CRD42015025015 .

[Professional divers: analysis of critical issues and proposal of a health protocol for work fitness].

PubMed

Pedata, Paola; Corvino, Anna Rita; Napolitano, Raffaele Carmine; Garzillo, Elpidio Maria; Furfaro, Ciro; Lamberti, Monica

2016-01-20

From many years now, thanks to the development of modern diving techniques, there has been a rapid spread of diving activities everywhere. In fact, divers are ever more numerous both among the Armed Forces and civilians who dive for work, like fishing, biological research and archeology. The aim of the study was to propose a health protocol for work fitness of professional divers keeping in mind the peculiar work activity, existing Italian legislation that is almost out of date and the technical and scientific evolution in this occupational field. We performed an analysis of the most frequently occurring diseases among professional divers and of the clinical investigation and imaging techniques used for work fitness assessment of professional divers. From analysis of the health protocol recommended by D.M. 13 January 1979 (Ministerial Decree), that is most used by occupational health physician, several critical issues emerged. Very often the clinical investigation and imaging techniques still used are almost obsolete, ignoring the execution of simple and inexpensive investigations that are more useful for work fitness assessment. Considering the out-dated legislation concerning diving disciplines, it is necessary to draw up a common health protocol that takes into account clinical and scientific knowledge and skills acquired in this area. This protocol's aim is to propose a useful tool for occupational health physicians who work in this sector.

Built to last? The sustainability of health system improvements, interventions and change strategies: a study protocol for a systematic review.

PubMed

Braithwaite, Jeffrey; Testa, Luke; Lamprell, Gina; Herkes, Jessica; Ludlow, Kristiana; McPherson, Elise; Campbell, Margie; Holt, Joanna

2017-11-12

The sustainability of healthcare interventions and change programmes is of increasing importance to researchers and healthcare stakeholders interested in creating sustainable health systems to cope with mounting stressors. The aim of this protocol is to extend earlier work and describe a systematic review to identify, synthesise and draw meaning from studies published within the last 5 years that measure the sustainability of interventions, improvement efforts and change strategies in the health system. The protocol outlines a method by which to execute a rigorous systematic review. The design includes applying primary and secondary data collection techniques, consisting of a comprehensive database search complemented by contact with experts, and searching secondary databases and reference lists, using snowballing techniques. The review and analysis process will occur via an abstract review followed by a full-text screening process. The inclusion criteria include English-language, peer-reviewed, primary, empirical research articles published after 2011 in scholarly journals, for which the full text is available. No restrictions on location will be applied. The review that results from this protocol will synthesise and compare characteristics of the included studies. Ultimately, it is intended that this will help make it easier to identify and design sustainable interventions, improvement efforts and change strategies. As no primary data were collected, ethical approval was not required. Results will be disseminated in conference presentations, peer-reviewed publications and among policymaker bodies interested in creating sustainable health systems. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Educational program for middle-level public health nurses to develop new health services regarding community health needs: protocol for a randomized controlled trial.

PubMed

Yoshioka-Maeda, Kyoko; Katayama, Takafumi; Shiomi, Misa; Hosoya, Noriko

2018-01-01

Developing health services is a key strategy for improving the community health provided by public health nurses. However, an effective educational program for improving their skills in planning such services has not been developed. To describe our program and its evaluation protocol for the education of middle-level public health nurses to improve their skills in developing new health services to fulfil community health needs in Japan. In this randomized control trial, eligible participants in Japan will be randomly allocated to an intervention group and a control wait-list group. We will provide 8 modules of web-based learning for public health nurses from July to October 2018. To ensure fairness of educational opportunity, the wait-list group will participate in the same program as the intervention group after collection of follow-up data of the intervention group. The primary outcomes will be evaluated using the scale of competency measurement of creativity for public health nurses at baseline, immediately after the intervention. Secondary outcomes will be knowledge and performance regarding program development of public health nurses. This study will enable the analysis of the effects of the educational program on public health nurses for improving their competency to develop new health services for fulfilling community health needs and enriching health care systems. We registered our study protocol to the University hospital Medical Information Network- Clinical Trials Registry approved by International Committee of Medical Journal Editors (No. UMIN000032176, April, 2018).

Impacts of Urban Agriculture on the Determinants of Health: Scoping Review Protocol.

PubMed

Audate, Pierre Paul; Fernandez, Melissa A; Cloutier, Geneviève; Lebel, Alexandre

2018-03-27

Since the 1990s, urban agriculture (UA) has contributed to improving food security in low- and middle- income countries. Now, it is implemented as a multifunctional intervention that can influence various determinants of health (eg, food security, social relationships). Studies of interest stem from several research disciplines, use a wide range of methods, and show results that are sometimes inconsistent. Current studies have not summarized the overall effects of UA on health and its determinants. The objective of this protocol is to develop a research strategy for a scoping review that characterizes studies of beneficial and adverse impacts of UA on health and its determinants in a wide range of disciplines. Initially, with the help of a library specialist, a list of publications will be obtained through a systematic search of seven electronic bibliographic databases: PubMed, Embase, MEDLINE (Embase), CINAHL Plus with full text, Academic Search Premier (EBSCO host), CAB Abstract (Ovid), and Web of Science. Secondly, a three-step screening by two independent reviewers will lead to a list of relevant publications that meet eligibility and inclusion criteria. Finally, data on the bibliography, type of participants, type of study, results of study, and countries will be extracted from included articles and analyzed to be presented in a peer-reviewed article. The findings are expected to identify research gaps that will inform needs for UA research in specific fields (eg, mental health), among certain population groups (eg, adults) or within different economic contexts (eg, low-, middle-, or high-income countries). Furthermore, the findings are expected to identify knowledge gaps and direct future research needs. This is an original study that seeks to integrate beneficial and adverse effects of UA on health at different level of influence (individuals, households, and community) in order to facilitate a better understanding of UA impacts. This protocol is a first of

Musculoskeletal health and work ability in physically demanding occupations: study protocol for a prospective field study on construction and health care workers.

PubMed

Lunde, Lars-Kristian; Koch, Markus; Knardahl, Stein; Wærsted, Morten; Mathiassen, Svend Erik; Forsman, Mikael; Holtermann, Andreas; Veiersted, Kaj Bo

2014-10-16

Musculoskeletal disorders have a profound impact on individual health, sickness absence and early retirement, particularly in physically demanding occupations. Demographics are changing in the developed countries, towards increasing proportions of senior workers. These senior workers may have particular difficulties coping with physically demanding occupations while maintaining good health. Previous studies investigating the relationship between physical work demands and musculoskeletal disorders are mainly based on self-reported exposures and lack a prospective design. The aim of this paper is to describe the background and methods and discuss challenges for a field study examining physical demands in construction and health care work and their prospective associations with musculoskeletal disorders, work ability and sickness absence. This protocol describes a prospective cohort study on 1200 construction and health care workers. Participants will answer a baseline questionnaire concerning musculoskeletal complaints, general health, psychosocial and organizational factors at work, work demands, work ability and physical activity during leisure. A shorter questionnaire will be answered every 6th months for a total of two years, together with continuous sickness absence monitoring during this period. Analysis will prospectively consider associations between self-reported physical demands and musculoskeletal disorders, work ability and sickness absence. To obtain objective data on physical exposures, technical measurements will be collected from two subgroups of N = 300 (Group A) and N = 160 (Group B) during work and leisure. Both group A and B will be given a physical health examination, be tested for physical capacity and physical activity will be measured for four days. Additionally, muscle activity, ground reaction force, body positions and physical activity will be examined during one workday for Group B. Analysis of associations between objectively measured

The role of academic health centres in building equitable health systems: a systematic review protocol

PubMed Central

Edelman, Alexandra; Taylor, Judy; Ovseiko, Pavel V; Topp, Stephanie M

2017-01-01

Introduction Academic health centres (AHCs) are complex organisations often defined by their ‘tripartite’ mission: to achieve high standards of clinical care, undertake clinical and laboratory research and educate health professionals. In the last decade, AHCs have moved away from what was a dominant focus on high impact (clinical) interventions for individuals, towards a more population-oriented paradigm requiring networked institutions and responsiveness to a range of issues including distribution of health outcomes and health determinants. Reflective of this paradigm shift is a growing interest in the role of AHCs in addressing health disparities and improving health system equity. This protocol outlines a systematic review that seeks to synthesise and critically appraise the current state of evidence on the role of AHCs in contributing to equitable health systems locally and globally. Methods and analysis Electronic searches will be conducted on a pilot list of bibliographic databases, including Google Scholar, Scopus, MEDLINE, PsycInfo, CINAHL, ERIC, ProQuest Dissertations & Theses, Cochrane Library, Evidence Based Medicine Reviews, Campbell Library and A+ Education, from 1 January 2000 to 31 December 2016. Apart from studies reporting clinical interventions or trials, all types of published peer-reviewed and grey literature will be included in the review. The single screening method will be employed in selecting studies, with two additional reviewers consulted where allocation is unclear. Quality and relevance appraisal utilising Joanna Briggs Institute critical appraisal tools will follow data extraction to a preprepared template. Thematic synthesis will be undertaken to develop descriptive themes and inform analysis. Ethics and dissemination As the review is focused on the analysis of secondary data, it does not require ethics approval. The results of the study will be disseminated through articles in peer-reviewed journals and trade publications as

A Peer-Led Electronic Mental Health Recovery App in an Adult Mental Health Service: Study Protocol for a Pilot Trial.

PubMed

Gulliver, Amelia; Banfield, Michelle; Reynolds, Julia; Miller, Sarah; Galati, Connie; Morse, Alyssa R

2017-12-07

There is growing demand for peer workers (people who use their own lived experience to support others in their recovery) to work alongside consumers to improve outcomes and recovery. Augmenting the workforce with peer workers has strong capacity to enhance mental health and recovery outcomes and make a positive contribution to the workforce within mental health systems and to the peer workers themselves. Technology-based applications are highly engaging and desirable methods of service delivery. This project is an exploratory proof-of-concept study, which aims to determine if a peer worker-led electronic mental (e-mental) health recovery program is a feasible, acceptable, and effective adjunct to usual treatment for people with moderate to severe mental illness. The study design comprises a recovery app intervention delivered by a peer worker to individual consumers at an adult mental health service. Evaluation measures will be conducted at post-intervention. To further inform the acceptability and feasibility of the model, consumers will be invited to participate in a focus group to discuss the program. The peer worker, peer supervisor, and key staff at the mental health service will also be individually interviewed to further evaluate the feasibility of the program within the health service and further inform its future development. The program will be delivered over a period of approximately 4 months, commencing June 2017. If the peer worker-led recovery app is found to be feasible, acceptable, and effective, it could be used to improve recovery in mental health service consumers. ©Amelia Gulliver, Michelle Banfield, Julia Reynolds, Sarah Miller, Connie Galati, Alyssa R Morse. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.12.2017.

A protocol for identifying suitable biomarkers to assess fish health: A systematic review

PubMed Central

2017-01-01

Background Biomarkers have been used extensively to provide the connection between external levels of contaminant exposure, internal levels of tissue contamination, and early adverse effects in organisms. Objectives To present a three-step protocol for identifying suitable biomarkers to assess fish health in coastal and marine ecosystems, using Gladstone Harbour (Australia) as a case study. Methods Prior to applying our protocol, clear working definitions for biomarkers were developed to ensure consistency with the global literature on fish health assessment. First, contaminants of concern were identified based on the presence of point and diffuse sources of pollution and available monitoring data for the ecosystem of interest. Second, suitable fish species were identified using fisheries dependent and independent data, and prioritised based on potential pathways of exposure to the contaminants of concern. Finally, a systematic and critical literature review was conducted on the use of biomarkers to assess the health of fish exposed to the contaminants of concern. Results/Discussion We present clear working definitions for bioaccumulation markers, biomarkers of exposure, biomarkers of effect and biomarkers of susceptibility. Based on emission and concentration information, seven metals were identified as contaminants of concern for Gladstone Harbour. Twenty out of 232 fish species were abundant enough to be potentially suitable for biomarker studies; five of these were prioritised based on potential pathways of exposure and susceptibility to metals. The literature search on biomarkers yielded 5,035 articles, of which 151met the inclusion criteria. Based on our review, the most suitable biomarkers include bioaccumulation markers, biomarkers of exposure (CYP1A, EROD, SOD, LPOX, HSP, MT, DNA strand breaks, micronuclei, apoptosis), and biomarkers of effect (histopathology, TAG:ST). Conclusion Our protocol outlines a clear pathway to identify suitable biomarkers to

[The factors that influence the use of clinical protocols according to the opinion of health center coordinators. The Research Group on the Evaluation and Improvement of Clinical Protocols].

PubMed

Saura-Llamas, J; Saturno Hernández, P J; Gaona Ramón, J M; Romero Román, J R; González Barberá, M

1999-11-15

To find the factors that affect the use of clinical protocols in primary care, in the view of primary care team coordinators, and the reasons why they are little followed, and to bring together suggestions for improvement. An opinion study, through a telephone survey. Primary health care. The health centres in Murcia with protocolized activity: 31 at the start of the project. The coordinators and those in charge of nursing, 62 people in all. After a pilot study, a structured telephone survey was carried out, administered by a trained interviewer who posed two open questions: why do you think that the professionals at your centre do not use the existing protocols more often? and: what suggestions would you make to improve the protocols and have them used more? A specialist company did the field-work in June and July 1996. There was a 98% reply rate. To the first question, coordinators thought that low use could be explained by excess demand and lack of time for consultations (33% of all replies), although they also cited other organisational problems in the centre, defects in protocols and lack of training. Those in charge of nursing gave very similar replies, with excess demand (39%) predominating. To the second question, on increasing the use of protocols, coordinators suggested that the protocols needed to be improved (44.8% of replies), and also cited the need for improvements in organisation and on-going training. Very similar answers came from the nursing side, where 43.5% highlighted the need to improve the protocol documents. The coordinators assumed that the clinical protocols were used little and could be improved. In their view the basic reason for their low use is excessive pressure from the patient-load. The key to using them more is improvement in the protocol documents.

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

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

PubMed

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

2014-05-29

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

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

PubMed Central

2013-01-01

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

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

PubMed

Yan, Hu; Su, Youxin; Chen, Lidian; Zheng, Guohua; Lin, Xueyi; Chen, Baojun; Zhou, Bihong; Zhang, Qing

2013-11-04

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

CT and MR Protocol Standardization Across a Large Health System: Providing a Consistent Radiologist, Patient, and Referring Provider Experience.

PubMed

Sachs, Peter B; Hunt, Kelly; Mansoubi, Fabien; Borgstede, James

2017-02-01

Building and maintaining a comprehensive yet simple set of standardized protocols for a cross-sectional image can be a daunting task. A single department may have difficulty preventing "protocol creep," which almost inevitably occurs when an organized "playbook" of protocols does not exist and individual radiologists and technologists alter protocols at will and on a case-by-case basis. When multiple departments or groups function in a large health system, the lack of uniformity of protocols can increase exponentially. In 2012, the University of Colorado Hospital formed a large health system (UCHealth) and became a 5-hospital provider network. CT and MR imaging studies are conducted at multiple locations by different radiology groups. To facilitate consistency in ordering, acquisition, and appearance of a given study, regardless of location, we minimized the number of protocols across all scanners and sites of practice with a clinical indication-driven protocol selection and standardization process. Here we review the steps utilized to perform this process improvement task and insure its stability over time. Actions included creation of a standardized protocol template, which allowed for changes in electronic storage and management of protocols, designing a change request form, and formation of a governance structure. We utilized rapid improvement events (1 day for CT, 2 days for MR) and reduced 248 CT protocols into 97 standardized protocols and 168 MR protocols to 66. Additional steps are underway to further standardize output and reporting of imaging interpretation. This will result in an improved, consistent radiologist, patient, and provider experience across the system.

Protocol: a 'One health' two year follow-up, mixed methods study on antibiotic resistance, focusing children under 5 and their environment in rural India.

PubMed

Stålsby Lundborg, Cecilia; Diwan, Vishal; Pathak, Ashish; Purohit, Manju R; Shah, Harshada; Sharma, Megha; Mahadik, Vijay K; Tamhankar, Ashok J

2015-12-30

Antibiotic resistance has been referred to as 'the greatest malice of the 21st century' and a global action plan was adopted by the World Health Assembly in 2015. There is a wealth of independent studies regarding antibiotics and resistant bacteria in humans, animals and their environment, however, integrated studies are lacking, particularly ones that simultaneously also take into consideration the health related behaviour of participants and healthcare providers. Such, 'One health' studies are difficult to implement, because of the complex teamwork that they entail. This paper describes the protocol of a study that investigates 'One health' issues regarding antibiotic use and antibiotic resistance in children and their environment in Indian villages. Both quantitative and qualitative studies are planned for a cohort of children, from 6 villages, and their surrounding environment. Repeated or continues data collection is planned over 2 years for quantitative studies. Qualitative studies will be conducted once. Studies include parents' health seeking behavior for their children (1-3 years of age at the onset), prescribing pattern of formal and informal healthcare providers, analysis of phenotypic antibiotic resistance of Escherichia coli from samples of stool from children and village animals, household drinking water, village source water and waste water, and investigation on molecular mechanisms governing resistance. Analysis of interrelationship of these with each other will also be done as basis for future interventions. Ethics approval has been obtained from the Institutional Ethics Committee R.D. Gardi Medical College, Ujjain, India (No: 2013/07/17-311). The findings of the study presented in this protocol will add to our knowledge about the multi-factorial nature of causes governing antibiotic use and antibiotic resistance from a 'One health' perspective. Our study will be the first of its kind addressing antibiotic use and resistance issues related to

Improving maternity care using a personal health record: study protocol for a stepped-wedge, randomised, controlled trial.

PubMed

Groenen, Carola J M; Faber, Marjan J; Kremer, Jan A M; Vandenbussche, Frank P H A; van Duijnhoven, Noortje T L

2016-04-16

A personal health record (PHR) is an online application through which individuals can access, manage, and share their health information in a private, secure, and confidential environment. Personal health records empower patients, facilitate collaboration among healthcare professionals, and improve health outcomes. Given these anticipated positive effects, we want to implement a PHR, named MyPregn@ncy, in a Dutch maternity care setting and to evaluate its effects in routine care. This paper presents the study protocol. The effects of implementing a PHR in maternity care on patients and professionals will be identified in a stepped-wedge, cluster-randomised, controlled trial. The study will be performed in the region of Nijmegen, a Dutch area with an average of 4,500 births a year and more than 230 healthcare professionals involved in maternity care. Data analyses will describe the effects of MyPregn@ncy on health outcomes in maternity care, quality of care from the patients' perspectives, and collaboration among healthcare professionals. Additionally, a process evaluation of the implementation of MyPregn@ncy will be performed. Data will be collected using data from the Dutch perinatal registry, questionnaires, interviews, and log data. The study is expected to yield new information about the effects, strengths, possibilities, and challenges to the implementation and usage of a PHR in routine maternal care settings. Results may lead to new insights and improvements in the quality of maternal and perinatal care. Netherlands Trial Register: NTR4063.

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

PubMed

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

2015-07-01

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. 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. 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. 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. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Study protocol for the Fukushima Health Management Survey.

PubMed

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

2012-01-01

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

Study Protocol for the Fukushima Health Management Survey

PubMed Central

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

2012-01-01

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

Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial.

PubMed

Salvo, Vera; Kristeller, Jean; Marin, Jesus Montero; Sanudo, Adriana; Lourenço, Bárbara Hatzlhoffer; Schveitzer, Mariana Cabral; D'Almeida, Vania; Morillo, Héctor; Gimeno, Suely Godoy Agostinho; Garcia-Campayo, Javier; Demarzo, Marcelo

2018-05-11

Mindfulness has been applied in the United States and Europe to improve physical and psychological health; however, little is known about its feasibility and efficacy in a Brazilian population. Mindfulness may also be relevant in tackling obesity and eating disorders by decreasing binge eating episodes-partly responsible for weight regain for a large number of people-and increasing awareness of emotional and other triggers for overeating. The aim of the present study protocol is to evaluate and compare the feasibility and efficacy of two mindfulness-based interventions (MBIs) addressing overweight and obesity in primary care patients: a general programme called Mindfulness-Based Health Promotion and a targeted mindful eating protocol called Mindfulness-Based Eating Awareness Training. A randomised controlled trial will be conducted to compare treatment as usual separately in primary care with both programmes (health promotion and mindful eating) added to treatment as usual. Two hundred forty adult women with overweight and obesity will be enrolled. The primary outcome will be an assessment of improvement in eating behaviour. Secondary outcomes will be (1) biochemical control; (2) anthropometric parameters, body composition, dietary intake and basal metabolism; and (3) levels of mindfulness, stress, depression, self-compassion and anxiety. At the end of each intervention, a focus group will be held to assess the programme's impact on the participants' lives, diet and health. A feasibility study on access to benefits from and importance of MBIs at primary care facilities will be conducted among primary care health care professionals and participants. Monthly maintenance sessions lasting at least 1 hour will be offered, according to each protocol, during the 3-month follow-up periods. This clinical trial will result in more effective mindfulness-based interventions as a complementary treatment in primary care for people with overweight and obesity. If the findings of

Policies and protocols for preventing transmission of HIV infection in oral health care in South Africa.

PubMed

Ogunbodede, E O; Rudolph, M J

2002-12-01

Human immunodeficiency virus (HIV) infection constitutes an unparalleled public health challenge. The unique nature of most oral health procedures, instrumentation and patient-care settings requires specific strategies and protocols aimed at preventing the transmission of HIV/AIDS between oral health care providers and patients, as well as between patients themselves. The present study investigated the level of information and training about protocols and policies for preventing the transmission of HIV/AIDS in oral health care settings in South Africa. The data collection techniques utilised available information, in-depth interviews and an open-ended questionnaire. The respondents were 20 purposively selected key informants who were senior officers for HIV/AIDS programmes and/or oral health organisations. Sixteen (80%) of the respondents reported that there were no existing oral health policies on HIV/AIDS in their health care institutions or organisations. None of the interviewees knew of any specific protocols on HIV/AIDS in the oral health care setting that emanated from South Africa. In addition, none of the dental professional associations had established an infection control committee or a support system for members who might become infected with HIV and develop AIDS. Territorial boundaries existed between sectors within the medical disciplines, as well as between the medical and oral health disciplines. Numerous general impediments were identified, such as prejudice, denial and fear, inadequate training and/or information about the infection, lack of representation and resources for policy planning, a lack of interest from the business sector, and approaching HIV/AIDS in the workplace as a 'one-time issue' Other obstacles identified included unemployment, poverty, illiteracy, disempowerment of women and inadequate communication of policies to service providers. Additional issues raised included the migrant labour systeM, complexities of language and culture

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

PubMed

Lawal, Adegboyega K; Rotter, Thomas; Kinsman, Leigh; Sari, Nazmi; Harrison, Liz; Jeffery, Cathy; Kutz, Mareike; Khan, Mohammad F; Flynn, Rachel

2014-09-19

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. 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. 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. PROSPERO CRD42014008853.

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

Evaluation of the relationship between compliance with the follow-up and treatment protocol and health literacy in bladder tumor patients.

PubMed

Turkoglu, Ali Riza; Demirci, Hakan; Coban, Soner; Guzelsoy, Muhammet; Toprak, Erdem; Aydos, Mustafa Murat; Ture, Deniz Azkan; Ustundag, Yasemin

2018-03-07

To investigate the relationship between the compliance of bladder cancer patients with cystoscopic follow-up and the treatment protocol, and their health literacy. Patients who underwent transurethral resection surgery for bladder tumor were found to have non-muscular invasive bladder carcinoma on pathology examination and then underwent cystoscopic follow-up for 1 year or more were included in the study. Cystoscopic follow-up was recommended to the low- and high-risk groups in terms of progression and recurrence. The patients were evaluated with the Health Literacy Survey-European Union scale. The mean age of the patients was 67.13 ± 10.77 years. The treatment continuity rate was 80.50% (n = 33) in the adequate health literacy group (n = 41) and significantly higher than the 56.50% (n = 48) rate in the inadequate health literacy group (n = 85) (p = .008). The health literacy results revealed that the health promotion and general index score was higher in the group of patients under the age of 65. Adequate health literacy in bladder cancer patients is associated with better compliance with the treatment protocol. Young patients show better compliance with the follow-up protocol recommended by the physician. Increasing the follow-up protocol compliance of elderly patients with inadequate health literacy is necessary.

An integrated community health worker intervention in rural Nepal: a type 2 hybrid effectiveness-implementation study protocol.

PubMed

Maru, Sheela; Nirola, Isha; Thapa, Aradhana; Thapa, Poshan; Kunwar, Lal; Wu, Wan-Ju; Halliday, Scott; Citrin, David; Schwarz, Ryan; Basnett, Indira; Kc, Naresh; Karki, Khem; Chaudhari, Pushpa; Maru, Duncan

2018-03-29

Evidence-based medicines, technologies, and protocols exist to prevent many of the annual 300,000 maternal, 2.7 million neonatal, and 9 million child deaths, but they are not being effectively implemented and utilized in rural areas. Nepal, one of South Asia's poorest countries with over 80% of its population living in rural areas, exemplifies this challenge. Community health workers are an important cadre in low-income countries where human resources for health and health care infrastructure are limited. As local women, they are uniquely positioned to understand and successfully navigate barriers to health care access. Recent case studies of large community health worker programs have highlighted the importance of training, both initial and ongoing, and accountability through structured management, salaries, and ongoing monitoring and evaluation. A gap in the evidence regarding whether such community health worker systems can change health outcomes, as well as be sustainably adopted at scale, remains. In this study, we plan to evaluate a community health worker system delivering an evidence-based integrated reproductive, maternal, newborn, and child health intervention as it is scaled up in rural Nepal. We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of an integrated reproductive, maternal, newborn, and child health intervention and the implementation process via a professional community health worker system. The intervention integrates five evidence-based approaches: (1) home-based antenatal care and post-natal care counseling and care coordination; (2) continuous surveillance of all reproductive age women, pregnancies, and children under age 2 years via a mobile application; (3) Community-Based Integrated Management of Newborn and Childhood Illness; (4) group antenatal and postnatal care; and 5) the Balanced Counseling Strategy to post-partum contraception. We will evaluate effectiveness using a pre-post quasi

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

Examining the Impact of Trauma-Informed Cognitive Behavioral Therapy on Perinatal Mental Health Outcomes Among Survivors of Intimate Partner Violence (The PATH Study): Protocol for a Feasibility Study.

PubMed

Jackson, Kimberley T; Parkinson, Sarah; Jackson, Brianna; Mantler, Tara

2018-05-25

Intimate partner violence (IPV) is a pervasive public health problem, impacting the health and quality of life of survivors worldwide. The trauma of IPV is associated with a high incidence of mental illness, namely depressive and anxiety disorders, and posttraumatic stress disorder (PTSD). Moreover, literature endorses cognitive behavioral therapy (CBT) interventions as a gold standard for those with symptomatology consistent with anxiety disorders, mood disorders, and PTSD. However, efficacy has not been evaluated among a population of pregnant survivors of IPV. We present the protocol that will be used to explore the efficacy of trauma-informed cognitive behavioral therapy on maternal and child health outcomes for pregnant women with PTSD, depression, or anxiety symptomatology resulting from IPV. A secondary aim will be to test the validity and feasibility of study methodology to support the successful implementation of a full-scale randomized controlled trial. The Promoting Attachment Through Healing (PATH) study will use a mixed-methods approach grounded in an intersectional feminist framework to explore the effectiveness of trauma-informed CBT for pregnant survivors of IPV. Study participants will be recruited through the hospital-based Perinatal Mental Health Clinic (London, Ontario, Canada). A feasibility sample of 20 pregnant women (cohort 1) will be selected to engage in an eight-session antenatal CBT intervention facilitated by the program's perinatal clinical nurse specialist, with evaluation at baseline, at two months postpartum (intervention and online questionnaire), and at six and twelve months postpartum (online questionnaire only). Concurrently, we will conduct a retrospective audit of 100 medical charts (cohort 2; 50 charts of perinatal women who received CBT and 50 charts of women who did not receive perinatal CBT) from the past five years. The efficacy of the intervention will be based on a reduction of mental illness symptomatology, improved

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

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

2014-06-23

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. 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. 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. UMIN000010826. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

Efficacy of the unified protocol for the treatment of emotional disorders in the Spanish public mental health system using a group format: study protocol for a multicenter, randomized, non-inferiority controlled trial.

PubMed

Osma, Jorge; Suso-Ribera, Carlos; García-Palacios, Azucena; Crespo-Delgado, Elena; Robert-Flor, Cristina; Sánchez-Guerrero, Ana; Ferreres-Galan, Vanesa; Pérez-Ayerra, Luisa; Malea-Fernández, Amparo; Torres-Alfosea, Mª Ángeles

2018-03-12

Emotional disorders, which include both anxiety and depressive disorders, are the most prevalent psychological disorders according to recent epidemiological studies. Consequently, public costs associated with their treatment have become a matter of concern for public health systems, which face long waiting lists. Because of their high prevalence in the population, finding an effective treatment for emotional disorders has become a key goal of today's clinical psychology. The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders might serve the aforementioned purpose, as it can be applied to a variety of disorders simultaneously and it can be easily performed in a group format. The study is a multicenter, randomized, non-inferiority controlled clinical trial. Participants will be 220 individuals with emotional disorders, who are randomized to either a treatment as usual (individual cognitive behavioral therapy) or to a Unified Protocol condition in group format. Depression, anxiety, and diagnostic criteria are the primary outcome measures. Secondary measures include the assessment of positive and negative affect, anxiety control, personality traits, overall adjustment, and quality of life. An analysis of treatment satisfaction is also conducted. Assessment points include baseline, post-treatment, and three follow-ups at 3, 6, and 12 months. To control for missing data and possible biases, intention-to-treat and per-protocol analyses will be performed. This is the first randomized, controlled clinical trial to test the effectiveness of a transdiagnostic intervention in a group format for the treatment of emotional disorders in public settings in Spain. Results obtained from this study may have important clinical, social, and economic implications for public mental health settings in Spain. Retrospectively registered at https://clinicaltrials.gov/ . Trial NCT03064477 (March 10, 2017). The trial is active and recruitment is ongoing. Recruitment

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

Protocol for the Women And Their Children’s Health (WATCH) Study: A Cohort of Pregnancy and Beyond

PubMed Central

Hure, Alexis J; Collins, Clare E; Giles, Warwick B; Wright, Ian MR; Smith, Roger

2012-01-01

Background The developmental origins of health and disease is a conceptual framework that helps explain the links between our early life exposures and later health outcomes, and is a burgeoning field of research. In this report, we describe the study protocol used in a prospective cohort of women recruited during pregnancy, with postnatal follow-up of the mothers and offspring. Methods The Women And Their Children’s Health (WATCH) cohort (n = 180 women) is being conducted at the John Hunter Hospital, Australia (from June 2006). Women attended study visits during pregnancy at 19, 24, 30, and 36 weeks’ gestation. Postnatal follow-up of the women and their offspring occurred at 3-month intervals during the first year after birth and annually thereafter, until age 4 years. Fetal ultrasound scans were performed at each pregnancy visit. Pregnancy and birth data were obtained from hospital records. Data collection has included maternal and child anthropometric, biochemical, dietary, physical activity, socioeconomic, medical, and other variables. Conclusions The 2 most novel components of our prospective cohort study are (1) the regular and systematic tracking of fetal and child growth and body composition, starting in the second trimester of pregnancy and continuing to age 4 years, and (2) the detailed maternal and child dietary data collection, including biochemical parameters. Detailed cohorts that collect data on the early nutritional, physiological, and social determinants of health are valuable. Despite its relatively small sample size, many hypotheses on developmental origins can be tested or piloted using data collected from the WATCH cohort. PMID:22374367

World Health Organization "School Mental Health Manual"-based training for school teachers in Urban Lahore, Pakistan: study protocol for a randomized controlled trial.

PubMed

Imran, Nazish; Rahman, Atif; Chaudhry, Nakhshab; Asif, Aftab

2018-05-24

The teacher's role in school mental health initiatives cannot be overemphasized. Despite global evidence of educational interventions in improving teachers' knowledge and attitudes regarding mental health, this area remains under researched in Pakistan. This paper presents a study protocol of a pilot randomized controlled trial to examine the effectiveness of a teacher training intervention for improving mental health literacy and self-efficacy among school teachers in urban Lahore, Pakistan. The randomized controlled trial will follow the CONSORT guidelines. Participants will be allocated to the Intervention group (receiving the World Health Organization, Eastern Mediterranean Region (WHO-EMRO) School Mental Health Manual-based intervention in three 6-h, face-to-face sessions) or a waitlist control group (not receiving training during the study period). Participants will be teachers of private schools with similar broad demographic characteristics in an inner city area of Lahore. The primary outcome measures for the trial is teachers' mental health literacy. It will be assessed by using the previously applied (during WHO training of Master Trainers) self-administered questionnaire in both groups pre and post training and at 3 months' follow-up. Secondary outcomes include: for teachers: Teachers' self-efficacy (assessed by the Teachers' Sense of Self Efficacy Scale (TSES) short form.); for students (11-16 years): socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire (assessed at baseline and 3 months post intervention); for schools: the WHO School Psychosocial Profile Questionnaire (baseline and 3 months post intervention). Given the high prevalence of child mental health problems, stigma and lack of services, it is important to consider alternate avenues for promoting positive mental health among youth. This pilot study should establish the effectiveness of the WHO-EMRO School Mental Health Manual

Comprehensive overview of computer-based health information tailoring: a scoping review protocol.

PubMed

Ghalibaf, Azadeh Kamel; Nazari, Elham; Gholian-Aval, Mahdi; Tabesh, Hamed; Tara, Mahmood

2017-12-27

Tailoring health information to the needs of individuals has become an important part of modern health communications. Tailoring has been addressed by researchers from different disciplines leading to the emergence of a wide range of approaches, making the newcomers confused. In order to address this, a comprehensive overview of the field with the indications of research gaps, tendencies and trends will be helpful. As a result, a systematic protocol was outlined to conduct a scoping review within the field of computer-based health information tailoring. This protocol is based on the York's five-stage framework outlined by Arksey and O'Malley. A field-specific structure was defined as a basis for undertaking each stage. The structure comprised three main aspects: system design , information communication and evaluation . Five leading databases were searched: PubMed, Scopus, Science Direct, EBSCO and IEEE and a broad search strategy was used with less strict inclusion criteria to cover the breadth of evidence. Theoretical frameworks were used to develop the data extraction form and a rigorous approach was introduced to identify the categories from data. Several explanatory-descriptive methods were considered to analyse the data, from which some were proposed to be employed for the first time in scoping studies. This study investigates the breadth and depth of existing literature on computer-tailoring and as a secondary analysis, does not require ethics approval. We anticipate that the results will identify research gaps and novel ideas for future studies and provide direction to combine methods from different disciplines. The research findings will be submitted for publication to relevant peer-reviewed journals and conferences targeting health promotion and patient education. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

BRain health and healthy AgeINg in retired rugby union players, the BRAIN Study: study protocol for an observational study in the UK.

PubMed

Gallo, Valentina; McElvenny, Damien; Hobbs, Catherine; Davoren, Donna; Morris, Huw; Crutch, Sebastian; Zetterberg, Henrik; Fox, Nick C; Kemp, Simon; Cross, Matthew; Arden, Nigel K; Davies, Madeleine A M; Malaspina, Andrea; Pearce, Neil

2017-12-26

Relatively little is known about the long-term health of former elite rugby players, or former sportspeople more generally. As well as the potential benefits of being former elite sportspersons, there may be potential health risks from exposures occurring during an individual's playing career, as well as following retirement. Each contact sport has vastly different playing dynamics, therefore exposing its players to different types of potential traumas. Current evidence suggests that these are not necessarily comparable in terms of pathophysiology, and their potential long-term adverse effects might also differ. There is currently limited but increasing evidence that poorer age-related and neurological health exists among former professional sportsmen exposed to repetitive concussions; however the evidence is limited on rugby union players, specifically. We present the protocol for a cross-sectional study to assess the association between self-reported history of concussion during a playing career, and subsequent measures of healthy ageing and neurological and cognitive impairment. We are recruiting a sample of approximately 200 retired rugby players (former Oxford and Cambridge University rugby players and members of the England Rugby International Club) aged 50 years or more, and collecting a number of general and neurological health-related outcome measures though validated assessments. Biomarkers of neurodegeneration (neurofilaments and tau) will be also be measured. Although the study is focusing on rugby union players specifically, the general study design and the methods for assessing neurological health are likely to be relevant to other studies of former elite sportspersons. The study has been approved by the Ethical Committee of London School of Hygiene and Tropical Medicine (reference: 11634-2). It is intended that results of this study will be published in peer-reviewed medical journals, communicated to participants, the general public and all relevant

Perceived effects of the economic recession on population mental health, well-being and provision of care by primary care users and professionals: a qualitative study protocol in Portugal

PubMed Central

Frasquilho, Diana; Cardoso, Graça; Pereira, Nádia; Silva, Manuela; Caldas-de-Almeida, José Miguel; Ferrão, João

2017-01-01

Introduction Economic recession periods can pose accentuated risks to population’s mental health and well-being as well as additional threats to health systems. Users and health professionals are key stakeholders in care delivery; however, little attention has been given to their experiences of the crisis. This paper presents a qualitative study protocol to assess users’ and health professionals’ perceptions about the effects of the post-2008 economic recession on mental health and care delivery in the Lisbon Metropolitan Area, Portugal. Methods and analysis The methodology to assess perceived effects of the economic recession by primary care users and professionals on population mental health, well-being and provision of care is presented. Focus groups with users and semistructured interviews with health professionals will be carried out in three primary healthcare units in Lisbon areas especially affected by the crisis. Thematic analysis of full-transcribed interviews will be conducted using an iterative and reflexive approach. Ethics and dissemination The study protocol was approved by the Ethics Committee of NOVA Medical School, NOVA University of Lisbon. The findings will be useful for other researchers and policy-makers to develop and implement the assessment of prevailing experiences of users and health professionals on the effects of the economic recession on mental health and quality of care in primary health context, promoting their involvement and contribution to services responsiveness. PMID:28871022

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-01-01

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

Impacts of Urban Agriculture on the Determinants of Health: Scoping Review Protocol

PubMed Central

Fernandez, Melissa A; Cloutier, Geneviève; Lebel, Alexandre

2018-01-01

Background Since the 1990s, urban agriculture (UA) has contributed to improving food security in low- and middle- income countries. Now, it is implemented as a multifunctional intervention that can influence various determinants of health (eg, food security, social relationships). Studies of interest stem from several research disciplines, use a wide range of methods, and show results that are sometimes inconsistent. Current studies have not summarized the overall effects of UA on health and its determinants. Objective The objective of this protocol is to develop a research strategy for a scoping review that characterizes studies of beneficial and adverse impacts of UA on health and its determinants in a wide range of disciplines. Methods Initially, with the help of a library specialist, a list of publications will be obtained through a systematic search of seven electronic bibliographic databases: PubMed, Embase, MEDLINE (Embase), CINAHL Plus with full text, Academic Search Premier (EBSCO host), CAB Abstract (Ovid), and Web of Science. Secondly, a three-step screening by two independent reviewers will lead to a list of relevant publications that meet eligibility and inclusion criteria. Finally, data on the bibliography, type of participants, type of study, results of study, and countries will be extracted from included articles and analyzed to be presented in a peer-reviewed article. Results The findings are expected to identify research gaps that will inform needs for UA research in specific fields (eg, mental health), among certain population groups (eg, adults) or within different economic contexts (eg, low-, middle-, or high-income countries). Furthermore, the findings are expected to identify knowledge gaps and direct future research needs. Conclusions This is an original study that seeks to integrate beneficial and adverse effects of UA on health at different level of influence (individuals, households, and community) in order to facilitate a better

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

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Marsh, G.M.; Callahan, C.; Pavlock, D.

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 positivemore » 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.« less

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

PubMed

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

2015-02-01

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

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

PubMed

Scheller, A; Rask, B

1993-04-01

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

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.

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

PubMed

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

2017-05-26

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

NADA Protocol for Behavioral Health. Putting Tools in the Hands of Behavioral Health Providers: The Case for Auricular Detoxification Specialists.

PubMed

Stuyt, Elizabeth B; Voyles, Claudia A; Bursac, Sara

2018-02-07

Background: The National Acupuncture Detoxification Association (NADA) protocol, a simple standardized auricular treatment has the potential to provide vast public health relief on issues currently challenging our world. This includes but is not limited to addiction, such as the opioid epidemic, but also encompasses mental health, trauma, PTSD, chronic stress, and the symptoms associated with these conditions. Simple accessible tools that improve outcomes can make profound differences. We assert that the NADA protocol can have greatest impact when broadly applied by behavioral health professionals, Auricular Detoxification Specialists (ADSes). Methods: The concept of ADS is described and how current laws vary from state to state. Using available national data, a survey of practitioners in three selected states with vastly different laws regarding ADSes, and interviews of publicly funded programs which are successfully incorporating the NADA protocol, we consider possible effects of ADS-friendly conditions. Results: Data presented supports the idea that conditions conducive to ADS practice lead to greater implementation. Program interviews reflect settings in which adding ADSes can in turn lead to improved outcomes. Discussion: The primary purpose of non-acupuncturist ADSes is to expand the access of this simple but effective treatment to all who are suffering from addictions, stress, or trauma and to allow programs to incorporate acupuncture in the form of the NADA protocol at minimal cost, when and where it is needed. States that have changed laws to allow ADS practice for this standardized ear acupuncture protocol have seen increased access to this treatment, benefiting both patients and the programs.

What are the physical and psychological health effects of suicide bereavement on family members? Protocol for an observational and interview mixed-methods study in Ireland

PubMed Central

Larkin, Celine; Corcoran, Paul; Matvienko-Sikar, Karen; Arensman, Ella

2017-01-01

Introduction Research indicates that experiencing the suicide of a relative can have a significant impact on family members' emotional health. However, research incorporating the impact of suicide bereavement on family members' physical health is sparse. This paper details the protocol for a mixed-methods study of suicide-bereaved family members. The study will primarily examine the physical and mental health needs of those bereaved by suicide. A secondary objective of the study is to describe the support service needs of family members bereaved by suicide. Methods and analysis A mixed-methods approach, using semistructured interviews and self-report questionnaires, will be used. Interviews will be conducted with a group of 15–20 relatives who experienced suicide bereavement. This protocol will follow the COREQ checklist criteria for the reporting of qualitative research interviews. Thematic analysis will be used to examine experiences and impact of bereavement on psychological and physical health. Self-report quantitative data on well-being will be analysed using descriptive statistics. Ethics and dissemination Ethical approval to conduct this study has been granted from the Clinical Research Ethics Committee of the Cork Teaching Hospitals. Pseudonyms will be given to participants to protect anonymity. It will be explained to participants that participation in the study is voluntary and they have to right to withdraw at any time. The findings of this research will be disseminated to regional, national and international audiences through publication in peer-reviewed international journals and presentations at scientific conferences. This research also forms part of a PhD thesis. PMID:28363930

Comparing the World Health Organization-versus China-recommended protocol for first-trimester medical abortion: a retrospective analysis

PubMed Central

Ngo, Thoai D; Park, Min Hae; Xiao, Yuanhong

2012-01-01

Objective To compare the effectiveness, in terms of complete abortion, of the World Health Organization (WHO)- and the China-recommended protocol for first-trimester medical abortion. Methods A retrospective analysis of clinical data from women presenting for first trimester medical abortion between January 2009 and August 2010 at reproductive health clinics in Qingdao, Xi’an, Nanjing, Nanning, and Zhengzhou was conducted. One clinic in Qingdao administered the WHO-recommended protocol (200 mg mifepristone orally followed by 0.8 mg misoprostol buccally 36–48 hours later). Four clinics in the other locations provided the China-recommended procedure (Day 1: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 2: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 3: 0.6 mg oral misoprostol). Data on reproductive and demographic characteristics were extracted from clinic records, and complete termination was determined on day 14 (post-mifepristone administration). Results A total of 337 women underwent early medical abortion (167 WHO- and 170 China-recommended procedures). Complete abortion was significantly higher among women who had the WHO protocol than those who received the China protocol (91.0% vs 77.7%, respectively; P < 0.001). Women using the China-recommended protocol were three times more likely to require an additional dose of misoprostol than women using the WHO protocol (21.8% vs 7.8%, respectively; P < 0.001), and had significantly more bleeding on the day of misoprostol administration (12.5 mL vs 18.5 mL; P < 0.001). Conclusion This clinical audit provides preliminary evidence suggesting the WHO-recommended protocol may be more effective than the China-recommended protocol for early medical abortion. A larger scale study is necessary to compare the methods’ effectiveness and acceptability. PMID:22505831

Comparing the World Health Organization-versus China-recommended protocol for first-trimester medical abortion: a retrospective analysis.

PubMed

Ngo, Thoai D; Park, Min Hae; Xiao, Yuanhong

2012-01-01

To compare the effectiveness, in terms of complete abortion, of the World Health Organization (WHO)- and the China-recommended protocol for first-trimester medical abortion. A retrospective analysis of clinical data from women presenting for first trimester medical abortion between January 2009 and August 2010 at reproductive health clinics in Qingdao, Xi'an, Nanjing, Nanning, and Zhengzhou was conducted. One clinic in Qingdao administered the WHO-recommended protocol (200 mg mifepristone orally followed by 0.8 mg misoprostol buccally 36-48 hours later). Four clinics in the other locations provided the China-recommended procedure (Day 1: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 2: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 3: 0.6 mg oral misoprostol). Data on reproductive and demographic characteristics were extracted from clinic records, and complete termination was determined on day 14 (post-mifepristone administration). A total of 337 women underwent early medical abortion (167 WHO- and 170 China-recommended procedures). Complete abortion was significantly higher among women who had the WHO protocol than those who received the China protocol (91.0% vs 77.7%, respectively; P < 0.001). Women using the China-recommended protocol were three times more likely to require an additional dose of misoprostol than women using the WHO protocol (21.8% vs 7.8%, respectively; P < 0.001), and had significantly more bleeding on the day of misoprostol administration (12.5 mL vs 18.5 mL; P < 0.001). This clinical audit provides preliminary evidence suggesting the WHO-recommended protocol may be more effective than the China-recommended protocol for early medical abortion. A larger scale study is necessary to compare the methods' effectiveness and acceptability.

A Machine-to-Machine protocol benchmark for eHealth applications - Use case: Respiratory rehabilitation.

PubMed

Talaminos-Barroso, Alejandro; Estudillo-Valderrama, Miguel A; Roa, Laura M; Reina-Tosina, Javier; Ortega-Ruiz, Francisco

2016-06-01

M2M (Machine-to-Machine) communications represent one of the main pillars of the new paradigm of the Internet of Things (IoT), and is making possible new opportunities for the eHealth business. Nevertheless, the large number of M2M protocols currently available hinders the election of a suitable solution that satisfies the requirements that can demand eHealth applications. In the first place, to develop a tool that provides a benchmarking analysis in order to objectively select among the most relevant M2M protocols for eHealth solutions. In the second place, to validate the tool with a particular use case: the respiratory rehabilitation. A software tool, called Distributed Computing Framework (DFC), has been designed and developed to execute the benchmarking tests and facilitate the deployment in environments with a large number of machines, with independence of the protocol and performance metrics selected. DDS, MQTT, CoAP, JMS, AMQP and XMPP protocols were evaluated considering different specific performance metrics, including CPU usage, memory usage, bandwidth consumption, latency and jitter. The results obtained allowed to validate a case of use: respiratory rehabilitation of chronic obstructive pulmonary disease (COPD) patients in two scenarios with different types of requirement: Home-Based and Ambulatory. The results of the benchmark comparison can guide eHealth developers in the choice of M2M technologies. In this regard, the framework presented is a simple and powerful tool for the deployment of benchmark tests under specific environments and conditions. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of an Internet-based learning program on venous leg ulcer nursing care in home health care--study protocol.

PubMed

Ylönen, Minna; Viljamaa, Jaakko; Isoaho, Hannu; Junttila, Kristiina; Leino-Kilpi, Helena; Suhonen, Riitta

2015-10-01

To describe the study protocol for a study of the effectiveness of an internet-based learning program on venous leg ulcer nursing care (eVLU) in home health care. The prevalence of venous leg ulcers is increasing as population age. The majority of these patients are treated in a municipal home healthcare setting. However, studies show nurses' lack of knowledge of ulcer nursing care. Quasi-experimental study with pre- and postmeasurements and non-equivalent intervention and comparison groups. During the study, nurses taking care of patients with a chronic leg ulcer in home health care in one Finnish municipality will use the eVLU. Nurses working in home health care in another Finnish municipality will not use it providing standard care. Nurses will complete three questionnaires during the study and they will also be observed three times at patients' homes. Nurses' perceived and theoretical knowledge is the primary outcome of the study. Funding for this study was received from the Finnish Foundation for Nursing Education in 2014. Data from this study will provide information about the effectiveness of an internet-based educational program. After completing the program nurses will be accustomed to using internet-based resources that can aid them in the nursing care of patients with a VLU. Nurses will also have better knowledge of VLU nursing care. This study is registered with the International Clinical Trials Registry, identifier NCT02224300. © 2015 John Wiley & Sons Ltd.

Perceived effects of the economic recession on population mental health, well-being and provision of care by primary care users and professionals: a qualitative study protocol in Portugal.

PubMed

Antunes, Ana; Frasquilho, Diana; Cardoso, Graça; Pereira, Nádia; Silva, Manuela; Caldas-de-Almeida, José Miguel; Ferrão, João

2017-09-03

Economic recession periods can pose accentuated risks to population's mental health and well-being as well as additional threats to health systems. Users and health professionals are key stakeholders in care delivery; however, little attention has been given to their experiences of the crisis. This paper presents a qualitative study protocol to assess users' and health professionals' perceptions about the effects of the post-2008 economic recession on mental health and care delivery in the Lisbon Metropolitan Area, Portugal. The methodology to assess perceived effects of the economic recession by primary care users and professionals on population mental health, well-being and provision of care is presented. Focus groups with users and semistructured interviews with health professionals will be carried out in three primary healthcare units in Lisbon areas especially affected by the crisis. Thematic analysis of full-transcribed interviews will be conducted using an iterative and reflexive approach. The study protocol was approved by the Ethics Committee of NOVA Medical School, NOVA University of Lisbon. The findings will be useful for other researchers and policy-makers to develop and implement the assessment of prevailing experiences of users and health professionals on the effects of the economic recession on mental health and quality of care in primary health context, promoting their involvement and contribution to services responsiveness. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

PubMed

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

2017-11-08

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

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

PubMed

Relton, Clare; Bissell, Paul; Smith, Christine; Blackburn, Joanna; Cooper, Cindy L; Nicholl, Jon; Tod, Angela; Copeland, Rob; Loban, Amanda; Chater, Tim; Thomas, Kate; Young, Tracy; Weir, Carol; Harrison, Gill; Millbourn, Alison; Manners, Rachel

2011-08-11

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

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

PubMed Central

2011-01-01

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

What are the physical and psychological health effects of suicide bereavement on family members? Protocol for an observational and interview mixed-methods study in Ireland.

PubMed

Spillane, Ailbhe; Larkin, Celine; Corcoran, Paul; Matvienko-Sikar, Karen; Arensman, Ella

2017-03-30

Research indicates that experiencing the suicide of a relative can have a significant impact on family members' emotional health. However, research incorporating the impact of suicide bereavement on family members' physical health is sparse. This paper details the protocol for a mixed-methods study of suicide-bereaved family members. The study will primarily examine the physical and mental health needs of those bereaved by suicide. A secondary objective of the study is to describe the support service needs of family members bereaved by suicide. A mixed-methods approach, using semistructured interviews and self-report questionnaires, will be used. Interviews will be conducted with a group of 15-20 relatives who experienced suicide bereavement. This protocol will follow the COREQ checklist criteria for the reporting of qualitative research interviews. Thematic analysis will be used to examine experiences and impact of bereavement on psychological and physical health. Self-report quantitative data on well-being will be analysed using descriptive statistics. Ethical approval to conduct this study has been granted from the Clinical Research Ethics Committee of the Cork Teaching Hospitals. Pseudonyms will be given to participants to protect anonymity. It will be explained to participants that participation in the study is voluntary and they have to right to withdraw at any time. The findings of this research will be disseminated to regional, national and international audiences through publication in peer-reviewed international journals and presentations at scientific conferences. This research also forms part of a PhD thesis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial.

PubMed

Miyamoto, Sheridan; Dharmar, Madan; Fazio, Sarina; Tang-Feldman, Yajarayma; Young, Heather M

2018-02-15

Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A 1c (HbA 1c ), and quality of life measures. Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback

Examining the Impact of Trauma-Informed Cognitive Behavioral Therapy on Perinatal Mental Health Outcomes Among Survivors of Intimate Partner Violence (The PATH Study): Protocol for a Feasibility Study

PubMed Central

Parkinson, Sarah; Jackson, Brianna

2018-01-01

Background Intimate partner violence (IPV) is a pervasive public health problem, impacting the health and quality of life of survivors worldwide. The trauma of IPV is associated with a high incidence of mental illness, namely depressive and anxiety disorders, and posttraumatic stress disorder (PTSD). Moreover, literature endorses cognitive behavioral therapy (CBT) interventions as a gold standard for those with symptomatology consistent with anxiety disorders, mood disorders, and PTSD. However, efficacy has not been evaluated among a population of pregnant survivors of IPV. Objective We present the protocol that will be used to explore the efficacy of trauma-informed cognitive behavioral therapy on maternal and child health outcomes for pregnant women with PTSD, depression, or anxiety symptomatology resulting from IPV. A secondary aim will be to test the validity and feasibility of study methodology to support the successful implementation of a full-scale randomized controlled trial. Methods The Promoting Attachment Through Healing (PATH) study will use a mixed-methods approach grounded in an intersectional feminist framework to explore the effectiveness of trauma-informed CBT for pregnant survivors of IPV. Study participants will be recruited through the hospital-based Perinatal Mental Health Clinic (London, Ontario, Canada). A feasibility sample of 20 pregnant women (cohort 1) will be selected to engage in an eight-session antenatal CBT intervention facilitated by the program’s perinatal clinical nurse specialist, with evaluation at baseline, at two months postpartum (intervention and online questionnaire), and at six and twelve months postpartum (online questionnaire only). Concurrently, we will conduct a retrospective audit of 100 medical charts (cohort 2; 50 charts of perinatal women who received CBT and 50 charts of women who did not receive perinatal CBT) from the past five years. The efficacy of the intervention will be based on a reduction of mental

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

PubMed

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

2015-01-28

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. 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. We discuss the scope for applying realist evaluation and the methodological challenges we encountered in developing this protocol. The study was approved by the Ethical Committee at Rennes University Hospital, France. Results will be published in scientific journals, and communicated

The GREENH-City interventional research protocol on health in all policies.

PubMed

Porcherie, Marion; Vaillant, Zoé; Faure, Emmanuelle; Rican, Stéphane; Simos, Jean; Cantoreggi, Nicola Luca; Heritage, Zoé; Le Gall, Anne Roue; Cambon, Linda; Diallo, Thierno Amadou; Vidales, Eva; Pommier, Jeanine

2017-10-18

This paper presents the research protocol of the GoveRnance for Equity, EnviroNment and Health in the City (GREENH-City) project funded by the National Institute for Cancer (Subvention N°2017-003-INCA). In France, health inequities have tended to increase since the late 1980s. Numerous studies show the influence of social, economic, geographic and political determinants on health inequities across the life course. Exposure to environmental factors is uneven across the population and may impact on health and health inequities. In cities, green spaces contribute to creating healthy settings which may help tackle health inequities. Health in All Policies (HiAP) represents one of the key strategies for addressing social and environmental determinants of health inequities. The objective of this research is to identify the most promising interventions to operationalize the HiAP approaches at the city level to tackle health inequities through urban green spaces. It is a participatory interventional research to analyze public policy in real life setting (WHO Healthy Cities). It is a mixed method systemic study with a quantitative approach for the 80 cities and a comparative qualitative multiple case-studies of 6 cities. The research combines 3 different lens: 1/a political analysis of how municipalities apply HiAP to reduce social inequities of health through green space policies and interventions 2/a geographical and topological characterization of green spaces and 3/ on-site observations of the use of green spaces by the inhabitants. City profiles will be identified regarding their HiAP approaches and the extent to which these cities address social inequities in health as part of their green space policy action. The analysis of the transferability of the results will inform policy recommendations in the rest of the Health City Network and widely for the French municipalities. The study will help identify factors enabling the implementation of the HiAP approach at a

Is health coaching effective in changing the health status and behaviour of prisoners?-a systematic review protocol.

PubMed

Almondes, Nadja; Downie, Denise; Cinar, Ayse B; Richards, Derek; Freeman, Ruth

2017-07-03

This is a protocol for a systematic review of the impact of health coaching on changing the health behaviour of offenders. Prisoners are more likely to suffer from health-related issues when compared to the general population. Health coaching has been shown to influence health outcomes of patients with chronic conditions. This review, therefore, aims to assess the effectiveness of health coaching interventions on the health of adolescent and adult offenders in custodial institutions. We plan to conduct a systematic review of the current literature on health coaching interventions delivered in the prison setting. We will include randomised controlled trials and observational studies that compare health coaching to the usual care or other alternative interventions. The ideal interventions will be delivered either by health professionals or peer coaches, and the outcomes extracted in the data collection will be disease-specific, clients' life and self-management skills, behavioural and psychosocial outcomes. If appropriate, a meta-analysis of the data collected will be carried out on the last stage of the review. This systematic review will identify and gather evidence on the impact of health coaching interventions delivered in the prison setting and can function as a supporting material for health professionals, prison staff, the healthcare system, and public health departments when considering delivering health coaching. PROSPERO CRD42016053237 .

Evaluating community health centers’ adoption of a new global capitation payment (eCHANGE) study protocol

PubMed Central

Angier, H; O’Malley, JP; Marino, M; McConnell, KJ; Cottrell, E; Jacob, RL; Likumahuwa-Ackman, S; Heintzman, J; Huguet, N; Bailey, SR; DeVoe, JE

2017-01-01

Primary care patient-centered medical homes (PCMHs) are an effective healthcare delivery model. Evidence regarding the most effective payment models for increased coordination efforts is sparse. This protocol paper describes the evaluation of an Alternative Payment Methodology (APM) implemented in a subset of Oregon community health centers (CHCs), using a prospective matched observational design. The APM is a primary care payment reform intervention that changed Oregon’s Medicaid payment for several CHCs from fee-for-service reimbursement to a per-member-per-month capitated payment. We will implement a difference-in-difference analytic approach to evaluate pre-post APM changes between intervention and control groups, including: 1) clinic-level outcomes, 2) patient-level clinical outcomes, and 3) patient-level econometric outcomes. Findings from the project will be of national significance, as there is a need for evidence regarding how novel payment methods might enhance PCMH capabilities and support their capacity to produce better quality and outcomes. If this capitated payment method is proven effective, study findings will inform dissemination of similar APMs nationwide. PMID:27836506

Evaluating community health centers' adoption of a new global capitation payment (eCHANGE) study protocol.

PubMed

Angier, H; O'Malley, J P; Marino, M; McConnell, K J; Cottrell, E; Jacob, R L; Likumahuwa-Ackman, S; Heintzman, J; Huguet, N; Bailey, S R; DeVoe, J E

2017-01-01

Primary care patient-centered medical homes (PCMHs) are an effective healthcare delivery model. Evidence regarding the most effective payment models for increased coordination efforts is sparse. This protocol paper describes the evaluation of an Alternative Payment Methodology (APM) implemented in a subset of Oregon community health centers (CHCs), using a prospective matched observational design. The APM is a primary care payment reform intervention that changed Oregon's Medicaid payment for several CHCs from fee-for-service reimbursement to a per-member-per-month capitated payment. We will implement a difference-in-difference analytic approach to evaluate pre-post APM changes between intervention and control groups, including: 1) clinic-level outcomes, 2) patient-level clinical outcomes, and 3) patient-level econometric outcomes. Findings from the project will be of national significance, as there is a need for evidence regarding how novel payment methods might enhance PCMH capabilities and support their capacity to produce better quality and outcomes. If this capitated payment method is proven effective, study findings will inform dissemination of similar APMs nationwide. Copyright © 2016 Elsevier Inc. All rights reserved.

Development of a Behavior Change Intervention to Improve Sexual Health Service Use Among University Undergraduate Students: Mixed Methods Study Protocol.

PubMed

Cassidy, Christine; Steenbeek, Audrey; Langille, Donald; Martin-Misener, Ruth; Curran, Janet

2017-11-02

University students are at risk for acquiring sexually transmitted infections and suffering other negative health outcomes. Sexual health services offer preventive and treatment interventions that aim to reduce these infections and associated health consequences. However, university students often delay or avoid seeking sexual health services. An in-depth understanding of the factors that influence student use of sexual health services is needed to underpin effective sexual health interventions. In this study, we aim to design a behavior change intervention to address university undergraduate students' use of sexual health services at two universities in Nova Scotia, Canada. This mixed methods study consists of three phases that follow a systematic approach to intervention design outlined in the Behaviour Change Wheel. In Phase 1, we examine patterns of sexual health service use among university students in Nova Scotia, Canada, using an existing dataset. In Phase 2, we identify the perceived barriers and enablers to students' use of sexual health services. This will include focus groups with university undergraduate students, health care providers, and university administrators using a semistructured guide, informed by the Capability, Opportunity, Motivation-Behaviour Model and Theoretical Domains Framework. In Phase 3, we identify behavior change techniques and intervention components to develop a theory-based intervention to improve students' use of sexual health services. This study will be completed in March 2018. Results from each phase and the finalized intervention design will be reported in 2018. Previous intervention research to improve university students' use of sexual health services lacks a theoretical assessment of barriers. This study will employ a mixed methods research design to examine university students' use of sexual health service and apply behavior change theory to design a theory- and evidence-based sexual health service intervention. Our

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

PubMed

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

2015-02-01

Unemployment insurance is an important social protection policy that buffers unemployed workers against poverty and poor health. Most unemployment insurance studies focus on whether increases in unemployment insurance generosity are predictive of poverty and health outcomes. Less work has used theory-driven approaches to understand and explain how and why unemployment insurance works, for whom, and under what circumstances. Given this, we present a realist synthesis protocol that seeks to unpack how contextual influences trigger relevant mechanisms to generate poverty and health outcomes. In this protocol, we conceptualize unemployment insurance as a key social protection policy; provide a supporting rationale on the need for a realist synthesis; and describe our process on identifying context-mechanism-outcome pattern configurations. Six methodological steps are described: initial theory development, search strategy; selection and appraisal of documents; data extraction; analysis and synthesis process; and presentation and dissemination of revised theory. Our forthcoming realist synthesis will be the first to build and test theory on the intended and unintended outcomes of unemployment insurance policies. Anticipated findings will allow policymakers to move beyond 'black box' approaches to consider 'mechanism-based' explanations that explicate the logic on how and why unemployment insurance matters. Copyright © 2014 Elsevier Ltd. All rights reserved.

Caries risk assessment tool and prevention protocol for public health nurses in mother and child health centers, Israel.

PubMed

Natapov, Lena; Dekel-Markovich, Dan; Granit-Palmon, Hadas; Aflalo, Efrat; Zusman, Shlomo Paul

2018-01-01

Dental caries is the most prevalent chronic disease in children. Caries risk assessment tools enable the dentists, physicians, and nondental health care providers to assess the individual's risk. Intervention by nurses in primary care settings can contribute to the establishment of oral health habits and prevention of dental disease. In Israel, Mother and Child Health Centers provide free preventive services for pregnant women and children by public health nurses. A caries prevention program in health centers started in 2015. Nurses underwent special training regarding caries prevention. A customized Caries Risk Assessment tool and Prevention Protocol for nurses, based on the AAPD tool, was introduced. A two-step evaluation was conducted which included a questionnaire and in-depth phone interviews. Twenty-eight (out of 46) health centers returned a completed questionnaire. Most nurses believed that oral health preventive services should be incorporated into their daily work. In the in-depth phone interviews, nurses stated that the integration of the program into their busy daily schedule was realistic and appropriate. The lack of specific dental module for computer program was mentioned as an implementation difficulty. The wide use of our tool by nurses supports its simplicity and feasibility which enables quick calculation and informed decision making. The nurses readily embraced the tool and it became an integral part of their toolkit. We provide public health nurses with a caries risk assessment tool and prevention protocol thus integrating oral health into general health of infants and toddlers. © 2017 Wiley Periodicals, Inc.

Application of an Original Wildfire Smoke Health Cost Benefits Transfer Protocol to the Western US, 2005-2015

NASA Astrophysics Data System (ADS)

Jones, Benjamin A.; Berrens, Robert P.

2017-11-01

Recent growth in the frequency and severity of US wildfires has led to more wildfire smoke and increased public exposure to harmful air pollutants. Populations exposed to wildfire smoke experience a variety of negative health impacts, imposing economic costs on society. However, few estimates of smoke health costs exist and none for the entire Western US, in particular, which experiences some of the largest and most intense wildfires in the US. The lack of cost estimates is troublesome because smoke health impacts are an important consideration of the overall costs of wildfire. To address this gap, this study provides the first time series estimates of PM2.5 smoke costs across mortality and several morbidity measures for the Western US over 2005-2015. This time period includes smoke from several megafires and includes years of record-breaking acres burned. Smoke costs are estimated using a benefits transfer protocol developed for contexts when original health data are not available. The novelty of our protocol is that it synthesizes the literature on choices faced by researchers when conducting a smoke cost benefit transfer. On average, wildfire smoke in the Western US creates 165 million in annual morbidity and mortality health costs.

Application of an Original Wildfire Smoke Health Cost Benefits Transfer Protocol to the Western US, 2005-2015.

PubMed

Jones, Benjamin A; Berrens, Robert P

2017-11-01

Recent growth in the frequency and severity of US wildfires has led to more wildfire smoke and increased public exposure to harmful air pollutants. Populations exposed to wildfire smoke experience a variety of negative health impacts, imposing economic costs on society. However, few estimates of smoke health costs exist and none for the entire Western US, in particular, which experiences some of the largest and most intense wildfires in the US. The lack of cost estimates is troublesome because smoke health impacts are an important consideration of the overall costs of wildfire. To address this gap, this study provides the first time series estimates of PM2.5 smoke costs across mortality and several morbidity measures for the Western US over 2005-2015. This time period includes smoke from several megafires and includes years of record-breaking acres burned. Smoke costs are estimated using a benefits transfer protocol developed for contexts when original health data are not available. The novelty of our protocol is that it synthesizes the literature on choices faced by researchers when conducting a smoke cost benefit transfer. On average, wildfire smoke in the Western US creates $165 million in annual morbidity and mortality health costs.

Regional South Australia Health (RESONATE) survey: study protocol

PubMed Central

Jones, Martin; Gillam, Marianne; May, Esther

2018-01-01

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

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

PubMed

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

2017-05-25

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

Effectiveness of the 'Home-but not Alone' mobile health application educational programme on parental outcomes: a randomized controlled trial, study protocol.

PubMed

Shorey, Shefaly; Ng, Yvonne Peng Mei; Danbjørg, Dorthe Boe; Dennis, Cindy-Lee; Morelius, Evalotte

2017-01-01

The aim of this study was to describe a study protocol that evaluates the effectiveness of the 'Home-but not Alone' educational programme delivered via a mobile health application in improving parenting outcomes. The development in mobile-based technology gives us the opportunity to develop an accessible educational programme that can be potentially beneficial to new parents. However, there is a scarcity of theory-based educational programmes that have incorporated technology such as a mobile health application in the early postpartum period. A randomized controlled trial with a two-group pre-test and post-test design. The data will be collected from 118 couples. Eligible parents will be randomly allocated to either a control group (receiving routine care) or an intervention group (routine care plus access to the 'Home-but not Alone' mobile health application. Outcome measures comprise of parenting self-efficacy, social support, parenting satisfaction and postnatal depression. Data will be collected at the baseline (on the day of discharge) and at four weeks postpartum. This will be an empirical study that evaluates a theory-based educational programme delivered via an innovative mobile health application on parental outcomes. Results from this study will enhance parenting self-efficacy, social support and parenting satisfaction, which may then reduce parental risks of postnatal depression. © 2016 John Wiley & Sons Ltd.

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

PubMed

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

2017-04-13

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

Impacts on health outcomes and on resource utilisation of home-based parenteral chemotherapy administration: a systematic review protocol.

PubMed

Mittaine-Marzac, Benedicte; De Stampa, Matthieu; Bagaragaza, Emmanuel; Ankri, Joël; Aegerter, Philippe

2018-05-09

Despite the demonstrated feasibility and policies to enable more to receive chemotherapy at home, in a few countries, parenteral chemotherapy administration at home remains currently marginal. Of note, findings of different studies on health outcomes and resources utilisation vary, leading to conflicting results. This protocol outlines a systematic review that seeks to synthesise and critically appraise the current state of evidence on the comparison between home setting and hospital setting for parenteral chemotherapy administration within the same high standards of clinical care. This protocol has been prepared following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols approach. Electronic searches will be conducted on bibliographic databases selected from the earliest available data through 15 November 2017 published in French and English languages. Additional potential papers in the selected studies and grey literature will be also included in the review. The review will include all types of studies exploring patients receiving anticancer drugs for injection at home compared with patients receiving the drugs in a hospital setting, and will assess at least one of the following criteria: patients' health outcomes, patients' or caregivers' satisfaction, resource utilisation with cost savings, and incentives and/or barriers of each admission setting according to patients' and relatives' points of view. Two reviewers will independently screen studies and extract relevant data from the included studies. Methodological quality of studies will be assessed using the 'Quality Assessment Tool for Quantitative Studies' developed by the Effective Public Health Practice Project tool, in addition to the Consolidated Health Economic Evaluation Reporting Standards statement for economic studies. As the review is focused on the analysis of secondary data, it does not require ethics approval. The results of the study will be disseminated through

Knowledge transfer and exchange frameworks in health and their applicability to palliative care: scoping review protocol.

PubMed

Prihodova, Lucia; Guerin, Suzanne; Kernohan, W George

2015-07-01

To review knowledge transfer and exchange frameworks used in health, to analyse the core concepts of these frameworks and appraise their potential applicability to palliative care. Although there are over 60 different models of knowledge transfer and exchange designed for various areas of the fields of health care, many remain largely unrefined and untested. There is a lack of studies that create guidelines for scaling-up successful implementation of research findings and of proven models ensuring that patients have access to optimal health care, guided by current research. The protocol for this scoping review was devised according to the guidelines proposed by Arksey and O'Malley (2005) and Levac et al. (2010). The protocol includes decisions about the review objectives, inclusion criteria, search strategy, study selection, data extraction, quality assessment, data synthesis and plans for dissemination. The review will allow us to identify the currently used models of knowledge transfer and exchange in healthcare setting and analyse their applicability to the complex demands of palliative care. Results from this review will identify effective way of translating different types of knowledge to different PC providers and could be used in hospital, community and home based PC and future research. © 2015 John Wiley & Sons Ltd.

Measurement of health system performance at district level: A study protocol

PubMed Central

Sharma, Atul; Prinja, Shankar; Aggarwal, Arun Kumar

2018-01-01

Background Limited efforts have been observed in low and middle income countries to undertake health system performance assessment at district level. Absence of a comprehensive data collection tool and lack of a standardised single summary measure defining overall performance are some of the main problems. Present study has been undertaken to develop a summary composite health system performance index at district level. Methods A broad range of indicators covering all six domains as per building block framework were finalized by an expert panel. The domains were classified into twenty sub-domains, with 70 input and process indicators to measure performance. Seven sub-domains for assessing health system outputs and outcomes were identified, with a total of 28 indicators. Districts in Haryana state from north India were selected for the study. Primary and secondary data will be collected from 378 health facilities, district and state health directorate headquarters. Indicators will be normalized, aggregated to generate composite performance index at district level. Domain specific scores will present the quality of individual building block domains in the public health system. Robustness of the results will be checked using sensitivity analysis. Expected impact for public health: The study presents a methodology for comprehensive assessment of all health system domains on basis of input, process, output and outcome indicators which has never been reported from India. Generation of this index will help identify policy and implementation areas of concern and point towards potential solutions. Results may also help understand relationships between individual building blocks and their sub-components. Significance for public health Measuring performance of health system is important to understand progress and challenges, and create systems that are efficient, equitable and patient-focused. However, very few assessments of such nature have been observed in low and middle

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

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. © The Author(s) 2015.

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

PubMed Central

2012-01-01

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

How do nurses, midwives and health visitors contribute to protocol-based care? A synthesis of the UK literature.

PubMed

Ilott, Irene; Booth, Andrew; Rick, Jo; Patterson, Malcolm

2010-06-01

To explore how nurses, midwives and health visitors contribute to the development, implementation and audit of protocol-based care. Protocol-based care refers to the use of documents that set standards for clinical care processes with the intent of reducing unacceptable variations in practice. Documents such as protocols, clinical guidelines and care pathways underpin evidence-based practice throughout the world. An interpretative review using the five-stage systematic literature review process. The data sources were the British Nursing Index, CINAHL, EMBASE, MEDLINE and Web of Science from onset to 2005. The Journal of Integrated Care Pathways was hand searched (1997-June 2006). Thirty three studies about protocol-based care in the United Kingdom were appraised using the Qualitative Assessment and Review Instrument (QARI version 2). The literature was synthesized inductively and deductively, using an official 12-step guide for development as a framework for the deductive synthesis. Most papers were descriptive, offering practitioner knowledge and positive findings about a locally developed and owned protocol-based care. The majority were instigated in response to clinical need or service re-design. Development of protocol-based care was a non-linear, idiosyncratic process, with steps omitted, repeated or completed in a different order. The context and the multiple purposes of protocol-based care influenced the development process. Implementation and sustainability were rarely mentioned, or theorised as a change. The roles and activities of nurses were so understated as to be almost invisible. There were notable gaps in the literature about the resource use costs, the engagement of patients in the decision-making process, leadership and the impact of formalisation and new roles on inter-professional relations. Documents that standardise clinical care are part of the history of nursing as well as contemporary evidence-based care and expanded roles. Considering the

Health-social partnership intervention programme for community-dwelling older adults: a research protocol for a randomized controlled trial.

PubMed

Wong, Kwan Ching; Wong, Frances Kam Yuet; Chang, Katherine Ka Pik

2015-11-01

This paper aims to describe the research protocol that will be used to determine the effectiveness of a health-social partnership intervention programme among community-dwelling older adults. Ageing in place is a preferred option for overcoming challenges of the increasing prevalence of chronic diseases and the risk for hospitalization associated with the ageing population. Nevertheless, our knowledge of how to implement this concept is limited. The integrated efforts of health and social services may help to enable older adults to live with a sense of control over their daily life and to be independent to the fullest extent possible in the community. This is a randomized, controlled trial. Participants are community-dwelling older adults referred from a community centre. Sample size calculation was based on power analysis. The intervention group will receive the programme with the standard protocols guided by a comprehensive assessment-intervention-evaluation framework. Home visits and telephones follow-up will be employed as means of conducting the interventions and monitoring their progress. The customary care group will receive placebo social calls. The duration of the interventions will be 3 months. The study was funded by the School of Nursing in Hong Kong. Research Ethics Committee approval was obtained in September 2014. The results of this research are expected to enable older adults to stay in the community with optimal health and well-being. Health and social sciences are integrated into the practice in this research protocol. The scarce literature on this topic means that this study can also provide an opportunity to bridge the caring gap among older adults. © 2015 John Wiley & Sons Ltd.

Cognitive behaviour therapy for older adults experiencing insomnia and depression in a community mental health setting: Study protocol for a randomised controlled trial.

PubMed

Sadler, Paul; McLaren, Suzanne; Klein, Britt; Jenkins, Megan; Harvey, Jack

2015-11-27

Cognitive behaviour therapy for insomnia (CBT-I) is a well-established treatment; however, the evidence is largely limited to homogenous samples. Although emerging research has indicated that CBT-I is also effective for comorbid insomnia, CBT-I has not been tested among a complex sample of older adults with comorbid insomnia and depression. Furthermore, no study has explored whether modifying CBT-I to target associated depressive symptoms could potentially enhance sleep and mood outcomes. Therefore, this study aims to report a protocol designed to test whether an advanced form of CBT for insomnia and depression (CBT-I-D) is more effective at reducing insomnia and depressive symptoms compared to a standard CBT-I and psychoeducation control group (PCG) for older adults in a community mental health setting. We aim to recruit 150 older adults with comorbid insomnia who have presented to community mental health services for depression. Eligible participants will be randomly allocated via block/cluster randomisation to one of three group therapy conditions: CBT-I, CBT-I-D, or PCG. Participants who receive CBT-I will only practice strategies designed to improve their sleep, whereas participants who receive CBT-I-D will practice additional strategies designed to also improve their mood. This trial will implement a mixed-methods design involving quantitative outcome measures and qualitative focus groups. The primary outcome measures are insomnia and depression severity, and secondary outcomes are anxiety, hopelessness, beliefs about sleep, comorbid sleep conditions, and health. Outcomes will be assessed at pre-intervention (week 0), post-intervention (week 8), and 3-month follow-up (week 20). This CBT study protocol has been designed to address comorbid insomnia and depression for older adults receiving community mental health services. The proposed trial will determine whether CBT-I is more effective for older adults with comorbid insomnia and depression compared to a PCG

The role of academic health centres in building equitable health systems: a systematic review protocol.

PubMed

Edelman, Alexandra; Taylor, Judy; Ovseiko, Pavel V; Topp, Stephanie M

2017-05-29

Academic health centres (AHCs) are complex organisations often defined by their 'tripartite' mission: to achieve high standards of clinical care, undertake clinical and laboratory research and educate health professionals. In the last decade, AHCs have moved away from what was a dominant focus on high impact (clinical) interventions for individuals, towards a more population-oriented paradigm requiring networked institutions and responsiveness to a range of issues including distribution of health outcomes and health determinants. Reflective of this paradigm shift is a growing interest in the role of AHCs in addressing health disparities and improving health system equity. This protocol outlines a systematic review that seeks to synthesise and critically appraise the current state of evidence on the role of AHCs in contributing to equitable health systems locally and globally. Electronic searches will be conducted on a pilot list of bibliographic databases, including Google Scholar, Scopus, MEDLINE, PsycInfo, CINAHL, ERIC, ProQuest Dissertations & Theses, Cochrane Library, Evidence Based Medicine Reviews, Campbell Library and A+ Education, from 1 January 2000 to 31 December 2016. Apart from studies reporting clinical interventions or trials, all types of published peer-reviewed and grey literature will be included in the review. The single screening method will be employed in selecting studies, with two additional reviewers consulted where allocation is unclear. Quality and relevance appraisal utilising Joanna Briggs Institute critical appraisal tools will follow data extraction to a preprepared template. Thematic synthesis will be undertaken to develop descriptive themes and inform analysis. As the review is focused on the analysis of secondary data, it does not require ethics approval. The results of the study will be disseminated through articles in peer-reviewed journals and trade publications as well as presentations at relevant national and international

The Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy Pilot Study protocol: a feasibility step-wedge cluster randomised trial to improve health providers' management of smoking during pregnancy

PubMed Central

Bonevski, Billie; Bovill, Michelle; Gruppetta, Maree; Oldmeadow, Chris; Palazzi, Kerrin; Atkins, Lou; Reath, Jennifer

2017-01-01

Introduction Indigenous women have the highest smoking prevalence during pregnancy (47%) in Australia. Health professionals report lack of knowledge, skills and confidence to effectively manage smoking among pregnant women in general. We developed a behaviour change intervention aimed to improve health professionals’ management of smoking in Indigenous pregnant women—the Indigenous Counselling And Nicotine (ICAN) QUIT in Pregnancy. This intervention includes webinar training for health professionals, an educational resources package for health professionals and pregnant women, free oral nicotine replacement therapy (NRT) for pregnant women, and audit and feedback on health professionals' performance. The aim of this study is to test the feasibility and acceptability of the ICAN QUIT in Pregnancy intervention to improve health professionals' provision of evidence-based culturally responsive smoking cessation care to Australian Indigenous pregnant smokers. Methods and analysis This protocol describes the design of a step-wedge cluster randomised pilot study. Six Aboriginal Medical Services (AMSs) are randomised into three clusters. Clusters receive the intervention staggered by 1 month. Health professionals report on their knowledge and skills pretraining and post-training and at the end of the study. Pregnant women are recruited and followed up for 3 months. The primary outcome is the recruitment rate of pregnant women. Secondary outcomes include feasibility of recruitment and follow-up of participating women, and webinar training of health professionals, measured using a designated log; and measures of effectiveness outcomes, including quit rates and NRT prescription rates. Ethics and dissemination In accordance with the Aboriginal Health and Medical Research Council guidelines, this study has been developed in collaboration with a Stakeholder and Consumer Aboriginal Advisory Panel (SCAAP). The SCAAP provides cultural consultation, advice and direction to

Measurement of health system performance at district level: A study protocol.

PubMed

Sharma, Atul; Prinja, Shankar; Aggarwal, Arun Kumar

2017-12-13

Limited efforts have been observed in low and middle income countries to undertake health system performance assessment at district level. Absence of a comprehensive data collection tool and lack of a standardised single summary measure defining overall performance are some of the main problems. Present study has been undertaken to develop a summary composite health system performance index at district level. A broad range of indicators covering all six domains as per building block framework were finalized by an expert panel. The domains were classified into twenty sub-domains, with 70 input and process indicators to measure performance. Seven sub-domains for assessing health system outputs and outcomes were identified, with a total of 28 indicators. Districts in Haryana state from north India were selected for the study. Primary and secondary data will be collected from 378 health facilities, district and state health directorate headquarters. Indicators will be normalized, aggregated to generate composite performance index at district level. Domain specific scores will present the quality of individual building block domains in the public health system. Robustness of the results will be checked using sensitivity analysis. The study presents a methodology for comprehensive assessment of all health system domains on basis of input, process, output and outcome indicators which has never been reported from India. Generation of this index will help identify policy and implementation areas of concern and point towards potential solutions. Results may also help understand relationships between individual building blocks and their sub-components.

Indicators and measurement tools for health system integration: a knowledge synthesis protocol.

PubMed

Oelke, Nelly D; Suter, Esther; da Silva Lima, Maria Alice Dias; Van Vliet-Brown, Cheryl

2015-07-29

Health system integration is a key component of health system reform with the goal of improving outcomes for patients, providers, and the health system. Although health systems continue to strive for better integration, current delivery of health services continues to be fragmented. A key gap in the literature is the lack of information on what successful integration looks like and how to measure achievement towards an integrated system. This multi-site study protocol builds on a prior knowledge synthesis completed by two of the primary investigators which identified 10 key principles that collectively support health system integration. The aim is to answer two research questions: What are appropriate indicators for each of the 10 key integration principles developed in our previous knowledge synthesis and what measurement tools are used to measure these indicators? To enhance generalizability of the findings, a partnership between Canada and Brazil was created as health system integration is a priority in both countries and they share similar contexts. This knowledge synthesis will follow an iterative scoping review process with emerging information from knowledge-user engagement leading to the refinement of research questions and study selection. This paper describes the methods for each phase of the study. Research questions were developed with stakeholder input. Indicator identification and prioritization will utilize a modified Delphi method and patient/user focus groups. Based on priority indicators, a search of the literature will be completed and studies screened for inclusion. Quality appraisal of relevant studies will be completed prior to data extraction. Results will be used to develop recommendations and key messages to be presented through integrated and end-of-grant knowledge translation strategies with researchers and knowledge-users from the three jurisdictions. This project will directly benefit policy and decision-makers by providing an easy

Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: study protocol for a randomized controlled trial.

PubMed

Bailey, Jeanette; Lelijveld, Natasha; Marron, Bethany; Onyoo, Pamela; Ho, Lara S; Manary, Mark; Briend, André; Opondo, Charles; Kerac, Marko

2018-04-24

Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The Combined Protocol for Acute Malnutrition Study (ComPAS) aims to simplify and unify the treatment of uncomplicated severe and moderate acute malnutrition (SAM and MAM) for children 6-59 months into one protocol in order to improve the global coverage, quality, continuity of care and cost-effectiveness of acute malnutrition treatment in resource-constrained settings. This study is a multi-site, cluster randomized non-inferiority trial with 12 clusters in Kenya and 12 clusters in South Sudan. Participants are 3600 children aged 6-59 months with uncomplicated acute malnutrition. This study will evaluate the impact of a simplified and combined protocol for the treatment of SAM and MAM compared to the standard protocol, which is the national treatment protocol in each country. We will assess recovery rate as a primary outcome and coverage, defaulting, death, length of stay, average weekly weight gain and average weekly mid-upper arm circumference (MUAC) gain as secondary outcomes. Recovery rate is defined across both treatment arms as MUAC ≥125 mm and no oedema for two consecutive visits. Per-protocol and intention-to-treat analyses will be conducted. If the combined protocol is shown to be non-inferior to the standard protocol, updating guidelines to use the combined protocol would eliminate the need for separate products, resources and procedures for MAM treatment. This would likely be more cost-effective, increase availability of services, enable earlier case finding and treatment before deterioration of MAM into SAM, promote better continuity of care and improve community perceptions of the programme. ISRCTN, ISRCTN30393230 . Registered on 16 March 2017.

[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.

Are child-centric aspects in newborn and child health systematic review and meta-analysis protocols and reports adequately reported?-two systematic reviews.

PubMed

Farid-Kapadia, Mufiza; Joachim, Kariym C; Balasingham, Chrinna; Clyburne-Sherin, April; Offringa, Martin

2017-03-06

Evidence suggests that newborn and child health systematic reviews and meta-analyses exhibit poor quality in reporting. The "Preferred Reporting Items in Systematic Review and Meta-Analysis" (PRISMA) and PRISMA-Protocols (PRISMA-P) checklists have been developed to improve the reporting of systematic review results and protocols, respectively. We aimed to evaluate the clarity and transparency in reporting of child-centric items in child health systematic reviews (SRs) and SR protocols and to identify areas where reporting could be strengthened. Two preliminary lists of potential child-centric reporting items were used to examine current reporting. The Cochrane, DARE, MEDLINE, and EMBASE libraries were searched from 2010 to 2014 for systematic reviews that included children. Each report and protocol that met the inclusion criteria had their quality of reporting assessed by their reporting of child-centric items. Quality of reporting was assessed per whether one third, one to two thirds, or more than two thirds of papers complied with potential child-centric potential modifications/extensions to PRISMA and were analyzed by the following: (i) paper type (i.e., report vs. protocol), (ii) publication type (i.e., Cochrane vs. non-Cochrane), and (iii) population type (i.e., child-only vs. mixed populations vs. family/maternal). Of the 414 eligible articles, 248 reports and 76 protocols were included. In 21 of 24 potential SR reporting items and 13 of 14 potential SR protocol reporting items, less than two thirds of papers met the child-centric reporting item requirements. Mixed population studies displayed significantly poorer reporting in comparison to child-only and family/maternal intervention studies for 11 potential SR reporting items (p < 0.05) and five potential SR protocol items (p < 0.05). When comparing non-Cochrane to Cochrane reports and protocols, five items in both lists were found to perform significantly poorer in non-Cochrane reports (p < 0

An oral health education video game for high caries risk children: study protocol for a randomized controlled trial.

PubMed

Aljafari, Ahmad; Rice, Colm; Gallagher, Jennifer Elizabeth; Hosey, Marie Therese

2015-05-28

Tooth decay is the most common chronic disease of childhood in the world. Many children develop caries early in their lives, and go on to develop further caries and sepsis as they grow up, indicating failure in prevention. As a result, many end up requiring general anaesthesia to undergo treatment for a disease that is completely preventable. Previous studies have suggested that the families of these children need better oral health education as well as better support in implementing healthy practices at home, as they feel impeded by broader life challenges. Parents of these children have suggested utilizing modern technologies, such as the internet, DVDs and video games as methods of delivery of education that might fit in with their busy lifestyles. The aim of this investigation is to assess the acceptability and efficiency of an oral health education video game directed at these children and their families. A two-armed phase-II randomized controlled trial will assess a children's oral health education video game in comparison with verbal oral health education in terms of: family satisfaction, effect on oral health knowledge, and effect on dietary and oral hygiene habits. Up to 110 four- to ten-year-old children, referred for tooth extraction under general anaesthesia due to caries, will be recruited. A sample of 45 participants in each group will be needed to provide 80% statistical power. The primary outcome measures for this study are: (1) parent and child satisfaction with the intervention, as indicated using a visual analogue scale; (2) improvement in the child's dietary knowledge measured by a pictorial dietary quiz; and (3) changes in the child's diet and oral hygiene habits, measured using a children's dietary questionnaire completed by the parent, and snacking and toothbrushing diaries completed by the child. Measures will be taken at baseline, directly after the intervention, and three months later. This study is a phase-II randomized controlled trial

Promoting Self-Regulation in Health Among Vulnerable Brazilian Children: Protocol Study

PubMed Central

Mattos, Luciana B.; Mattos, Marina B.; Barbosa, Ana P. O.; Bauer, Mariana da Silva; Strack, Maina H.; Rosário, Pedro; Reppold, Caroline T.; Magalhães, Cleidilene R.

2018-01-01

The Health and Education Ministries of Brazil launched the Health in School Program (Programa Saúde na Escola - PSE) in 2007. The purpose of the PSE is two-fold: articulate the actions of the education and health systems to identify risk factors and prevent them; and promote health education in the public elementary school system. In the health field, the self-regulation (SR) construct can contribute to the understanding of life habits which can affect the improvement of individuals' health. This research aims to present a program that promotes SR in health (SRH). This program (PSRH) includes topics on healthy eating and oral health from the PSE; it is grounded on the social cognitive framework and uses story tools to train 5th grade Brazilian students in SRH. The study consists of two phases. In Phase 1, teachers and health professionals participated in a training program on SRH, and in Phase 2, they will be expected to conduct an intervention in class to promote SRH. The participants were randomly assigned into three groups: the Condition I group followed the PSE program, the Condition II group followed the PSRH (i.e., PSE plus the SRH program), and the control group (CG) did not enroll in either of the health promotion programs. For the baseline of the study, the following measures and instruments were applied: Body Mass Index (BMI), Simplified Oral Hygiene Index (OHI-S), Previous Day Food Questionnaire (PFDQ), and Declarative Knowledge for Health Instrument. Data indicated that the majority are eutrophic children, but preliminary outcomes showed high percentages of children that are overweight, obese and severely obese. Moreover, participants in all groups reported high consumption of ultraprocessed foods (e.g., soft drinks, artificial juices, and candies). Oral health data from the CI and CII groups showed a prevalence of regular oral hygiene, while the CG presented good oral hygiene. The implementation of both PSE and PSRH are expected to help reduce health

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

Seib, Charrlotte; Whiteside, Eliza; Humphreys, Janice; Lee, Kathryn; Thomas, Patrick; Chopin, Lisa; Crisp, Gabrielle; O'Keeffe, Angela; Kimlin, Michael; Stacey, Andrew; Anderson, Debra

2014-01-08

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. 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. 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 health status in women.

Promoting physical activity and health literacy: study protocol for a longitudinal, mixed methods evaluation of a cross-provider workplace-related intervention in Germany (The AtRisk study).

PubMed

Schaller, Andrea; Dejonghe, Lea; Alayli-Goebbels, Adrienne; Biallas, Bianca; Froboese, Ingo

2016-07-22

Physical activity and health literacy are topics of utmost importance in the prevention of chronic diseases. The present article describes the study protocol for evaluating a cross-provider workplace-related intervention promoting physical activity and health literacy. The RE-AIM Framework will be the conceptual framework of the AtRisk study. A controlled natural experiment and a qualitative study will be conducted. The cross-provider intervention is based on the cooperation of the German Pension Fund Rhineland and cooperating German Statutory Health Insurances. It combines two components: a behavior-oriented lifestyle intervention and the assignment of a health coach. The single-provider intervention only includes the behavior-oriented lifestyle intervention. The quantitative study (natural experiment) encompasses three measuring points (T0 = start of the behavior-oriented lifestyle intervention (baseline); T1 = end of the behavior-oriented lifestyle intervention (16 weeks); T2 = 6 month follow-up) and will compare the effectiveness of the cross-provider workplace-related intervention compared with the single provider intervention. Participants are employees with health related risk factors. ANCOVA will be used to evaluate the effect of the intervention on the outcome variables leisure time physical (primary outcome) activity and health literacy (secondary outcome). The qualitative study comprises semi-structured interviews, systematic field notes of stakeholder meetings and document analyses. The AtRisk study will contribute towards the claim for cross-provider interventions and workplace-related approaches described in the new Preventive Health Care Act. The results of this study will inform providers, payers and policy makers about the effectiveness of a cross-provider workplace-related lifestyle intervention compared to a single-provider intervention. Beyond, the study will identify challenges for implementing cross-provider preventive

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

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

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

PubMed

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

2016-08-16

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. 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. 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 activities will involve a mixture of research feedback, policy briefs

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.

A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol

PubMed Central

Kangovi, Shreya; Mitra, Nandita; Turr, Lindsey; Huo, Hairong; Grande, David; Long, Judith A.

2017-01-01

Upstream interventions – e.g. housing programs and community health worker interventions-address socioeconomic and behavioral factors that influence health outcomes across diseases. Studying these types of interventions in clinical trials raises a methodological challenge: how should researchers measure the effect of an upstream intervention in a sample of patients with different diseases? This paper addresses this question using an illustrative protocol of a randomized controlled trial of collaborative-goal setting versus goal-setting plus community health worker support among patients multiple chronic diseases: diabetes, obesity, hypertension and tobacco dependence. At study enrollment, patients met with their primary care providers to select one of their chronic diseases to focus on during the study, and to collaboratively set a goal for that disease. Patients randomly assigned to a community health worker also received six months of support to address socioeconomic and behavioral barriers to chronic disease control. The primary hypothesis was that there would be differences in patients’ selected chronic disease control as measured by HbA1c, body mass index, systolic blood pressure and cigarettes per day, between the goal-setting alone and community health worker support arms. To test this hypothesis, we will conduct a stratum specific multivariate analysis of variance which allows all patients (regardless of their selected chronic disease) to be included in a single model for the primary outcome. Population health researchers can use this approach to measure clinical outcomes across diseases. PMID:27965180

Effective health care for older people resident in care homes: the optimal study protocol for realist review

PubMed Central

2014-01-01

Background Care homes in the UK rely on general practice for access to specialist medical and nursing care as well as referral to therapists and secondary care. Service delivery to care homes is highly variable in both quantity and quality. This variability is also evident in the commissioning and organisation of care home-specific services that range from the payment of incentives to general practitioners (GPs) to visit care homes, to the creation of care home specialist teams and outreach services run by geriatricians. No primary studies or systematic reviews have robustly evaluated the impact of these different approaches on organisation and resident-level outcomes. Our aim is to identify factors which may explain the perceived or demonstrated effectiveness of programmes to improve health-related outcomes in older people living in care homes. Methods/Design A realist review approach will be used to develop a theoretical understanding of what works when, why and in what circumstances. Elements of service models of interest include those that focus on assessment and management of residents’ health, those that use strategies to encourage closer working between visiting health care providers and care home staff, and those that address system-wide issues about access to assessment and treatment. These will include studies on continence, dignity, and speech and language assessment as well as interventions to promote person centred dementia care, improve strength and mobility, and nutrition. The impact of these interventions and their different mechanisms will be considered in relation to five key outcomes: residents’ medication use, use of out of hours’ services, hospital admissions (including use of Accident and Emergency) and length of hospital stay, costs and user satisfaction. An iterative three-stage approach will be undertaken that is stakeholder-driven and optimises the knowledge and networks of the research team. Discussion This realist review will

Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values.

PubMed

Ozarda, Yesim; Ichihara, Kiyoshi; Barth, Julian H; Klee, George

2013-05-01

The reference intervals (RIs) given in laboratory reports have an important role in aiding clinicians in interpreting test results in reference to values of healthy populations. In this report, we present a proposed protocol and standard operating procedures (SOPs) for common use in conducting multicenter RI studies on a national or international scale. The protocols and consensus on their contents were refined through discussions in recent C-RIDL meetings. The protocol describes in detail (1) the scheme and organization of the study, (2) the target population, inclusion/exclusion criteria, ethnicity, and sample size, (3) health status questionnaire, (4) target analytes, (5) blood collection, (6) sample processing and storage, (7) assays, (8) cross-check testing, (9) ethics, (10) data analyses, and (11) reporting of results. In addition, the protocol proposes the common measurement of a panel of sera when no standard materials exist for harmonization of test results. It also describes the requirements of the central laboratory, including the method of cross-check testing between the central laboratory of each country and local laboratories. This protocol and the SOPs remain largely exploratory and may require a reevaluation from the practical point of view after their implementation in the ongoing worldwide study. The paper is mainly intended to be a basis for discussion in the scientific community.

Health information technology adoption: Understanding research protocols and outcome measurements for IT interventions in health care.

PubMed

Colicchio, Tiago K; Facelli, Julio C; Del Fiol, Guilherme; Scammon, Debra L; Bowes, Watson A; Narus, Scott P

2016-10-01

To classify and characterize the variables commonly used to measure the impact of Information Technology (IT) adoption in health care, as well as settings and IT interventions tested, and to guide future research. We conducted a descriptive study screening a sample of 236 studies from a previous systematic review to identify outcome measures used and the availability of data to calculate these measures. We also developed a taxonomy of commonly used measures and explored setting characteristics and IT interventions. Clinical decision support is the most common intervention tested, primarily in non-hospital-based clinics and large academic hospitals. We identified 15 taxa representing the 79 most commonly used measures. Quality of care was the most common category of these measurements with 62 instances, followed by productivity (11 instances) and patient safety (6 instances). Measures used varied according to type of setting, IT intervention and targeted population. This study provides an inventory and a taxonomy of commonly used measures that will help researchers select measures in future studies as well as identify gaps in their measurement approaches. The classification of the other protocol components such as settings and interventions will also help researchers identify underexplored areas of research on the impact of IT interventions in health care. A more robust and standardized measurement system and more detailed descriptions of interventions and settings are necessary to enable comparison between studies and a better understanding of the impact of IT adoption in health care settings. Copyright © 2016 Elsevier Inc. All rights reserved.

A feasibility study comparing UK older adult mental health inpatient wards which use protected engagement time with other wards which do not: study protocol.

PubMed

Nolan, Fiona M; Fox, Chris; Cheston, Richard; Turner, David; Clark, Allan; Dodd, Emily; Khoo, Mary-Ellen; Gray, Richard

2016-01-01

Protected engagement time (PET) is a concept of managing staff time on mental health inpatient wards with the aim of increasing staff and patient interaction. Despite apparent widespread use of PET, there remains a dearth of evidence as to how it is implemented and whether it carries benefits for staff or patients. This protocol describes a study which is being carried out on mental health wards caring for older adults (aged over 65) in England. The study shares a large proportion of the procedures, measures and study team membership of a recently completed investigation of the impact of PET in adult acute mental health wards. The study aims to identify prevalence and components of PET to construct a model for the intervention, in addition to testing the feasibility of the measures and procedures in preparation for a randomised trial. The study comprises four modules and uses a mixed methods approach. Module 1 involves mapping all inpatient wards in England which provide care for older adults, including those with dementia, ascertaining how many of these provide PET and in what way. Module 2 uses a prospective cohort method to compare five older adult mental health wards that use PET with five that do not across three National Health Service (NHS) Foundation Trust sites. The comparison comprises questionnaires, observation tools and routinely collected clinical service data and combines validated measures with questions developed specifically for the study. Module 3 entails an in-depth case study evaluation of three of the participating PET wards (one from each NHS Trust site) using semi-structured interviews with patients, carers and staff. Module 4 describes the development of a model and fidelity scale for PET using the information derived from the other modules with a working group of patients, carers and staff. This is a feasibility study to test the application of the measures and methods in inpatient wards for older adults and develop a draft model for the

A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

PubMed Central

Fitzpatrick, Bridie; Watson, Nicholas; Cotmore, Richard; Wilson, Philip; Donaldson, Julia; Boyd, Kathleen; Zeanah, Charles; Norrie, John; Messow, Martina; Turner, Fiona; Irving, Susan

2013-01-01

Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home) is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child's neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510). PMID:24023537

A participatory approach to designing and enhancing integrated health information technology systems for veterans: protocol.

PubMed

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

2015-02-27

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. 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. 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. 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) developing visual model simulations based on

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

The characteristics of national health initiatives promoting earlier cancer diagnosis among adult populations: a systematic review protocol

PubMed Central

Calanzani, Natalia; Weller, David; Campbell, Christine

2017-01-01

Introduction The increasing burden of cancer morbidity and mortality has led to the development of national health initiatives to promote earlier cancer diagnosis and improve cancer survival. This protocol describes a systematic review aiming to identify the evidence about such initiatives among the adult population. We will describe their components, stakeholders and target populations, and summarise their outcomes. Methods and analysis We will search databases and websites for peer-reviewed publications and grey literature on national health initiatives in high-income countries as defined by the World Bank. Quantitative, qualitative and mixed-methods studies will be included and assessed for their methodological quality. Study selection, quality assessment and data extraction will be carried out independently by two reviewers. Narrative synthesis will be used to analyse the findings. Ethics and dissemination This systematic review analyses secondary data and ethical approval is not required. Review findings will be helpful to researchers, policy makers, governments and other key stakeholders developing similar initiatives and assessing cancer outcomes. The results will be submitted to a peer-reviewed journal in order to reach a diverse group of healthcare professionals, researchers and policy makers. This systematic review protocol is registered at PROSPERO (CRD42016047233). PMID:28698336

Benefit transfer protocol for long-term health risk valuation: A case of surface water contamination

NASA Astrophysics Data System (ADS)

Kask, Susan B.; Shogren, Jason F.

1994-10-01

In response to scarce financial resources, economists have promoted the concept of benefit transfer as a cost-effective alternative to new nonmarket valuation studies. Recent discussion on benefit transfer for improved water quality has focused on recreational benefits. While useful, the discussion must now be expanded to include another key benefit from improved water quality: the reduction in risk to public health. This paper develops a protocol for benefit transfer of long-term health risk reduction and presents a case study for surface water contamination. Challenges such as the multiple sources of risk, the mortality and morbidity effects indicated by a variety of symptoms, the long latency period between cause and effect, and an individual's ability to privately or collectively reduce the probability or severity of the risk are discussed.

The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation.

PubMed

Lelijveld, Natasha; Bailey, Jeanette; Mayberry, Amy; Trenouth, Lani; N'Diaye, Dieynaba S; Haghparast-Bidgoli, Hassan; Puett, Chloe

2018-04-24

Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child's weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM. This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant. We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies. ISRCTN 30393230 , date: 16/03/2017.

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

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

Japanese study on stratification, health, income, and neighborhood: study protocol and profiles of participants.

PubMed

Takada, Misato; Kondo, Naoki; Hashimoto, Hideki

2014-01-01

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. 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. 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. 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.

"Together at school"--a school-based intervention program to promote socio-emotional skills and mental health in children: study protocol for a cluster randomized controlled trial.

PubMed

Björklund, Katja; Liski, Antti; Samposalo, Hanna; Lindblom, Jallu; Hella, Juho; Huhtinen, Heini; Ojala, Tiina; Alasuvanto, Paula; Koskinen, Hanna-Leena; Kiviruusu, Olli; Hemminki, Elina; Punamäki, Raija-Leena; Sund, Reijo; Solantaus, Tytti; Santalahti, Päivi

2014-10-07

Schools provide a natural context to promote children's mental health. However, there is a need for more evidence-based, high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods. The aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the "Together at School" intervention program. The intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum, work environment of school staff, and parent-teacher collaboration methods. The evaluation study examines the effects of the intervention on children's socio-emotional skills and mental health in a cluster randomized controlled trial design with 1) an intervention group and 2) an active control group. Altogether 79 primary school participated at baseline. A multi-informant setting involves the children themselves, their parents, and teachers. The primary outcomes are measured using parent and teacher ratings of children's socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire and the Multisource Assessment of Social Competence Scale. Secondary outcomes for the children include emotional understanding, altruistic behavior, and executive functions (e.g. working memory, planning, and inhibition). Secondary outcomes for the teachers include ratings of e.g. school environment, teaching style and well-being. Secondary outcomes for both teachers and parents include e.g. emotional self-efficacy, child rearing practices, and teacher-parent collaboration. The data was collected at baseline (autumn 2013), 6 months after baseline, and will be collected also 18 months after baseline from the same participants. This study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a

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

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

Lehoux, Pascale; Gauthier, Philippe; Williams-Jones, Bryn; Miller, Fiona A; Fishman, Jennifer R; Hivon, Myriam; Vachon, Patrick

2014-06-21

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. 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. 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 shed light over potentially more valuable

Sleep, biological stress, and health among toddlers living in socioeconomically disadvantaged homes: A research protocol.

PubMed

Ordway, Monica R; Sadler, Lois S; Canapari, Craig A; Jeon, Sangchoon; Redeker, Nancy S

2017-12-01

Healthy sleep is important to behavioral, neurobiological, and physiologic health. In older children and adults, stress biomarkers, such as cortisol and C-reactive protein, increase when they do not practice healthy sleep habits. However, little is known about the relationships among sleep health, stress, and health outcomes among very young children living with socioeconomic adversity, a group that is particularly at risk for poor future health. The NIH-funded study described in this protocol addresses this scientific gap to improve understanding of these relationships during a critical developmental period in children's lives-toddlerhood. We will use a longitudinal design with repeated measures to prospectively examine the relationships among sleep health, stress, and toddlers' health from age 12 to 24 months, to address the following aims: i) examine changes in subjective and objective sleep health measures; ii) examine changes in stress biomarkers; iii) examine the cross-sectional and longitudinal relationships between sleep health measures and stress response; and iv) examine the cross-sectional and longitudinal relationships between sleep health measures, stress biomarkers, and toddlers' behavioral health. The sample will include 113 toddlers and their caregivers. We are collecting subjective and objective data on sleep health, multi-systemic biomarkers of stress, and toddlers' behavioral health. Generalized linear models will be used in the data analyses. Results from this study will be used to support development and testing of interventions, such as those that may improve sleep, among young children at risk for toxic stress. © 2017 Wiley Periodicals, Inc.

Planning oral health and clinical discharge in primary care: the comprehensive dental care protocol outcome.

PubMed

Cavalcanti, Yuri Wanderley; Dantas de Almeida, Leopoldina de Fátima; Barbosa, Ailma de Souza; Nascimento Padilha, Wilton Wilney

2015-03-01

The dental care must be driven by preventive and curative measures that can contribute to the population's oral health promotion. To evaluate the impact of the actions proposed by a comprehensive dental care protocol (CDCP) on the oral health condition of primary care users. The sample consisted of 32 volunteers, assisted throughout the six phases proposed by the CDCP: diagnosis of dental needs; resolution of urgencies; restorative interventions; application of promotional measures; evaluation of the achieved health level; and periodic controls. Data were collected through clinical exams, which measured the simplified oral hygiene index (OHI-S), gingival bleeding index (GBI) and the decayed, missing and filled teeth (DMFT) Index, before and after the CDCP was implemented. Statistical analysis consisted of the Wilcoxon test, at 5% significance level (α = 0.05). The OHI-S and GBI indices showed a significant reduction (p < 0.05) from the initial (1.4 ± 0.6 and 46.3 ± 19.9) to final condition (0.9 ± 0.3 and 21.5 ± 7.5). The decayed, missing and filled teeth and the missing teeth component were not significantly altered (p > 0.05), showing final values equal to 12.7 ± 9.6 and 5.6 ± 7.8, respectively. Decayed elements were fully converted into filled elements, and the final values of the decayed and filled elements were, respectively, 0.0 ± 0.0 and 7.3 ± 5.7 (p < 0.05). The enactment of the CDCP had a beneficial effect on the oral health of the population assisted by the dental services offered in primary care and this protocol seems to ft the public dental service demands. The CDCP can be useful to public dental service planning since it showed an efficient clinical outcome to the patients. We consider that this protocol should be employed in primary care oral health services in order to achieve overall upgrade, access enlargement and public oral health promotion.

Evaluating a health care provider delivered intervention to reduce intimate partner violence and mitigate associated health risks: study protocol for a randomized controlled trial in Mexico City.

PubMed

Falb, Kathryn L; Diaz-Olavarrieta, Claudia; Campos, Paola A; Valades, Jimena; Cardenas, Roosebelinda; Carino, Giselle; Gupta, Jhumka

2014-07-30

Intimate partner violence (IPV) victimization is a prevalent issue among women residing in Mexico City. Comprehensive and integrated health care provider (HCP) delivered programs in clinic-settings are needed, yet few have been evaluated in Latin America, including Mexico. In addition, there has been minimal attention to interventions among lower income women presenting at settings outside of antenatal care clinics. The current randomized controlled trial seeks to increase midlevel HCPs' capacity, specifically nurses, who are often the first point of contact in this setting, to identify women presenting at health clinics with experiences of IPV and to assist these women with health risk mitigation. Specific outcomes include changes in past-year IPV (physical and/or sexual), reproductive coercion, safety planning, use of community resources, and quality of life. Forty-two public health clinics in Mexico City were randomized to treatment or control clinics. Nurses meeting eligibility criteria in treatment groups received an intensive training on screening for IPV, providing supportive referrals, and assessing for health and safety risks. Nurses meeting eligibility criteria at control clinics received the standard of care which included a one-day training focused on sensitizing staff to IPV as a health issue and referral cards to give to women. Women were screened for eligibility (currently experiencing abuse in a heterosexual relationship, 18-44 years of age, non-pregnant or in first trimester) by research assistants in private areas of waiting rooms in health clinics. Consenting women completed a baseline survey and received the study protocol for that clinic. In treatment clinics, women received the nurse delivered session at baseline and received a follow-up counseling session after three months. Surveys are conducted at baseline, three months, and fifteen months from baseline. This study will provide important insight into whether a nurse-delivered program can

Bushehr Elderly Health (BEH) programme: study protocol and design of musculoskeletal system and cognitive function (stage II).

PubMed

Shafiee, Gita; Ostovar, Afshin; Heshmat, Ramin; Darabi, Hossein; Sharifi, Farshad; Raeisi, Alireza; Mehrdad, Neda; Shadman, Zhaleh; Razi, Faride; Amini, Mohammad Reza; Arzaghi, Seyed Masoud; Meybodi, Hamidreza Aghaei; Soltani, Akbar; Nabipour, Iraj; Larijani, Bagher

2017-08-04

Musculoskeletal disorders and cognitive diseases are prevalent, and they are significant determinants of morbidity and mortality in older adults. The aim of this study is to investigate the prevalence of musculoskeletal and cognitive diseases and their risk factors and also to assess their associations during future follow-ups. Bushehr Elderly Health (BEH) programme is a population-based prospective cohort study being conducted in Bushehr, a southern province of Iran. A total of 3000 older people aged ≥60 years participated in the first stage from which 2772 were eligible to participate in the second stage, which started after 2.5 years. Data including demographic status, lifestyle factors, general healthandmedical history, and mentalandfunctional health are collected through a questionnaire. Anthropometric measures, performance testsandmuscle strength, blood pressure and and body composition measurements are done. A total 25 cc venous blood is taken, and sera are stored at -80°C for possible future analyses. The study protocol was approved by the ethics committee of Endocrinology and Metabolism Research Institute, affiliated to Tehran University of Medical Science as well as the Research Ethics Committee of Bushehr University of Medical Sciences. A written informed consent was signed by all the participants. The study findings will show the prevalence of musculoskeletal disease, cognitive impairment and their risk factors in an elderly population. The participants will be followed during the study to measure the occurrence outcomes.This study will also have the potential to inform the development of beneficial interventions to improve the management of musculoskeletal and cognitive impairment in Iran and other countries in the Middle East.Our findings will be disseminated via scientific publication as well as presentation to stakeholders, including the patients, clinicians, the public and policymakers, via appropriate avenues. © Article author(s) (or their

Identifying and prioritising systematic review topics with public health stakeholders: A protocol for a modified Delphi study in Switzerland to inform future research agendas

PubMed Central

Mütsch, Margot; Kien, Christina; Gerhardus, Ansgar; Lhachimi, Stefan K

2017-01-01

Introduction The Cochrane Collaboration aims to produce relevant and top priority evidence that responds to existing evidence gaps. Hence, research priority setting (RPS) is important to identify which potential research gaps are deemed most important. Moreover, RPS supports future health research to conform both health and health evidence needs. However, studies that are prioritising systematic review topics in public health are surprisingly rare. Therefore, to inform the research agenda of Cochrane Public Health Europe (CPHE), we introduce the protocol of a priority setting study on systematic review topics in several European countries, which is conceptualised as pilot. Methods and analysis We will conduct a two-round modified Delphi study in Switzerland, incorporating an anonymous web-based questionnaire, to assess which topics should be prioritised for systematic reviews in public health. In the first Delphi round public health stakeholders will suggest relevant assessment criteria and potential priority topics. In the second Delphi round the participants indicate their (dis)agreement to the aggregated results of the first round and rate the potential review topics with the predetermined criteria on a four-point Likert scale. As we invite a wide variety of stakeholders we will compare the results between the different stakeholder groups. Ethics and dissemination We have received ethical approval from the ethical board of the University of Bremen, Germany (principal investigation is conducted at the University of Bremen) and a certificate of non-objection from the Canton of Zurich, Switzerland (fieldwork will be conducted in Switzerland). The results of this study will be further disseminated through peer reviewed publication and will support systematic review author groups (i.a. CPHE) to improve the relevance of the groups´ future review work. Finally, the proposed priority setting study can be used as a framework by other systematic review groups when

Maternal antecedents of adiposity and studying the transgenerational role of hyperglycemia and insulin (MAASTHI): a prospective cohort study : Protocol of birth cohort at Bangalore, India.

PubMed

Babu, Giridhara R; Murthy, Gvs; Deepa, R; Yamuna; Prafulla; Kumar, H Kiran; Karthik, Maithili; Deshpande, Keerti; Benjamin Neelon, Sara E; Prabhakaran, D; Kurpad, Anura; Kinra, Sanjay

2016-10-14

India is experiencing an epidemic of obesity-hyperglycaemia, which coincides with child bearing age for women. The epidemic can be sustained and augmented through transgenerational transmission of adiposity and glucose intolerance in women. This presents an opportunity for exploring a clear strategy for the control of this epidemic in India. We conducted a study between November 2013 and May 2015 to inform the design of a large pregnancy cohort study. Based on the findings of this pilot, we developed the protocol for the proposed birth cohort of 5000 women, the recruitment for which will start in April 2016. The protocol of the study documents the processes which aim at advancing the available knowledge, linking several steps in the evolution of obesity led hyperglycemia. Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin (MAASTHI) is a cohort study in the public health facilities in Bangalore, India. The objective of MAASTHI is to prospectively assess the effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in predicting the possible risk markers of later chronic diseases. The primary objective of the proposed study is to investigate the effect of glucose levels in pregnancy on skinfold thickness (adiposity) in infancy as a marker of future obesity and diabetes in offspring. The secondary objective is to assess the association between psychosocial environment of mothers and adverse neonatal outcomes including adiposity. The study aims to recruit 5000 pregnant women and follow them and their offspring for a period of 4 years. The institutional review board at The Indian Institute of Public Health (IIPH)-H, Bangalore, Public Health Foundation of India has approved the protocol. All participants are required to provide written informed consent. The findings from this study may help to address important questions on screening and management of high blood sugar in pregnancy. It

An efficacious oral health care protocol for immunocompromised patients.

PubMed

Solomon, C S; Shaikh, A B; Arendorf, T M

1995-01-01

A twice-weekly oral and perioral examination was provided to 120 patients receiving antineoplastic therapy. Sixty patients were monitored while following the traditional hospital oral care protocol (chlorhexidine, hydrogen peroxide, sodium bicarbonate, thymol glycol, benzocaine mouthrinse, and nystatin). The mouth care protocol was then changed (experimental protocol = chlorhexidine, benzocaine lozenges, amphotericin B lozenges), and patients were monitored until the sample size matched that of the hospital mouth care regime. There was a statistically significant reduction in oral complications upon introduction and maintenance of the experimental protocol.

Early economic evaluation of emerging health technologies: protocol of a systematic review

PubMed Central

2014-01-01

Background The concept of early health technology assessment, discussed well over a decade, has now been collaboratively implemented by industry, government, and academia to select and expedite the development of emerging technologies that may address the needs of patients and health systems. Early economic evaluation is essential to assess the value of emerging technologies, but empirical data to inform the current practice of early evaluation is limited. We propose a systematic review of early economic evaluation studies in order to better understand the current practice. Methods/design This protocol describes a systematic review of economic evaluation studies of regulated health technologies in which the evaluation is conducted prior to regulatory approval and when the technology effectiveness is not well established. Included studies must report an economic evaluation, defined as the comparative analysis of alternatives with respect to their associated costs and health consequences, and must evaluate some regulated health technology such as pharmaceuticals, biologics, high-risk medical devices, or biomarkers. We will conduct the literature search on multiple databases, including MEDLINE, EMBASE, the Centre for Reviews and Dissemination Databases, and EconLit. Additional citations will be identified via scanning reference lists and author searching. We suspect that many early economic evaluation studies are unpublished, especially those conducted for internal use only. Additionally, we use a chain-referral sampling approach to identify authors of unpublished studies who work in technology discovery and development, starting out with our contact lists and authors who published relevant studies. Citation screening and full-text review will be conducted by pairs of reviewers. Abstracted data will include those related to the decision context and decision problem of the early evaluation, evaluation methods (e.g., data sources, methods, and assumptions used to

Early economic evaluation of emerging health technologies: protocol of a systematic review.

PubMed

Pham, Ba'; Tu, Hong Anh Thi; Han, Dolly; Pechlivanoglou, Petros; Miller, Fiona; Rac, Valeria; Chin, Warren; Tricco, Andrea C; Paulden, Mike; Bielecki, Joanna; Krahn, Murray

2014-07-23

The concept of early health technology assessment, discussed well over a decade, has now been collaboratively implemented by industry, government, and academia to select and expedite the development of emerging technologies that may address the needs of patients and health systems. Early economic evaluation is essential to assess the value of emerging technologies, but empirical data to inform the current practice of early evaluation is limited. We propose a systematic review of early economic evaluation studies in order to better understand the current practice. This protocol describes a systematic review of economic evaluation studies of regulated health technologies in which the evaluation is conducted prior to regulatory approval and when the technology effectiveness is not well established. Included studies must report an economic evaluation, defined as the comparative analysis of alternatives with respect to their associated costs and health consequences, and must evaluate some regulated health technology such as pharmaceuticals, biologics, high-risk medical devices, or biomarkers. We will conduct the literature search on multiple databases, including MEDLINE, EMBASE, the Centre for Reviews and Dissemination Databases, and EconLit. Additional citations will be identified via scanning reference lists and author searching. We suspect that many early economic evaluation studies are unpublished, especially those conducted for internal use only. Additionally, we use a chain-referral sampling approach to identify authors of unpublished studies who work in technology discovery and development, starting out with our contact lists and authors who published relevant studies. Citation screening and full-text review will be conducted by pairs of reviewers. Abstracted data will include those related to the decision context and decision problem of the early evaluation, evaluation methods (e.g., data sources, methods, and assumptions used to identify, measure, and value the

Dietary phytochemical intake from foods and health outcomes: a systematic review protocol and preliminary scoping

PubMed Central

Guan, Vivienne X; Kent, Katherine

2017-01-01

Introduction Dietary phytochemicals are found in plant-based foods such as fruits, vegetables and grains and may be categorised in a nested hierarchical manner with many hundred individual phytochemicals identified to date. To associate phytochemical intakes with positive health outcomes, a fundamental step is to accurately estimate the dietary phytochemical intake from foods reported. The purpose of this systematic review protocol is to describe the process to be undertaken to summarise the evidence for food-based dietary phytochemical intakes and health outcomes for adults. Methods and analysis The review will be undertaken following the PRISMA guidelines and the Cochrane Handbook for Systematic Reviews of Interventions using the Review Manager software. Phytochemical subclasses (phenolic acids, flavanols, etc) will be used to search for relevant studies using the Web of Science and Scopus scientific databases. The retrieved studies will be screened based on inclusion of natural whole food items and health outcomes. Phytochemical studies related to cardiovascular disease, cancer, overweight, glucose tolerance, digestive, reproductive, macular and bone health and mental disorders, fatigue and immunity will be examined based on prior scoping. The evidence will be aggregated by the food types and health outcomes. Comparison of differences in the outcomes for randomised controlled trials and observational studies will be undertaken. The strength of the review lies in its focus on whole food items and health conditions rather than one type of phytochemical related to one single health condition. Subgroup and sensitivity analyses will be conducted where an adequate number of publications are found per phytochemical subclass. Dissemination By comparing the outcomes from experimental and observational studies, the review will determine whether the overall conclusions related to the phytochemical subclasses are the same between study types for the identified health

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

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

Implementation of Symptom Protocols for Nurses Providing Telephone‐Based Cancer Symptom Management: A Comparative Case Study

PubMed Central

Green, Esther; Ballantyne, Barbara; Tarasuk, Joy; Skrutkowski, Myriam; Carley, Meg; Chapman, Kim; Kuziemsky, Craig; Kolari, Erin; Sabo, Brenda; Saucier, Andréanne; Shaw, Tara; Tardif, Lucie; Truant, Tracy; Cummings, Greta G.; Howell, Doris

2016-01-01

ABSTRACT Background The pan‐Canadian Oncology Symptom Triage and Remote Support (COSTaRS) team developed 13 evidence‐informed protocols for symptom management. Aim To build an effective and sustainable approach for implementing the COSTaRS protocols for nurses providing telephone‐based symptom support to cancer patients. Methods A comparative case study was guided by the Knowledge to Action Framework. Three cases were created for three Canadian oncology programs that have nurses providing telephone support. Teams of researchers and knowledge users: (a) assessed barriers and facilitators influencing protocol use, (b) adapted protocols for local use, (c) intervened to address barriers, (d) monitored use, and (e) assessed barriers and facilitators influencing sustained use. Analysis was within and across cases. Results At baseline, >85% nurses rated protocols positively but barriers were identified (64‐80% needed training). Patients and families identified similar barriers and thought protocols would enhance consistency among nurses teaching self‐management. Twenty‐two COSTaRS workshops reached 85% to 97% of targeted nurses (N = 119). Nurses felt more confident with symptom management and using the COSTaRS protocols (p < .01). Protocol adaptations addressed barriers (e.g., health records approval, creating pocket versions, distributing with telephone messages). Chart audits revealed that protocols used were documented for 11% to 47% of patient calls. Sustained use requires organizational alignment and ongoing leadership support. Linking Evidence to Action Protocol uptake was similar to trials that have evaluated tailored interventions to improve professional practice by overcoming identified barriers. Collaborating with knowledge users facilitated interpretation of findings, aided protocol adaptation, and supported implementation. Protocol implementation in nursing requires a tailored approach. A multifaceted intervention approach increased nurses’ use

Protocol and Demonstrations of Probabilistic Reliability Assessment for Structural Health Monitoring Systems (Preprint)

DTIC Science & Technology

2011-11-01

assessment to quality of localization/characterization estimates. This protocol includes four critical components: (1) a procedure to identify the...critical factors impacting SHM system performance; (2) a multistage or hierarchical approach to SHM system validation; (3) a model -assisted evaluation...Lindgren, E. A ., Buynak, C. F., Steffes, G., Derriso, M., “ Model -assisted Probabilistic Reliability Assessment for Structural Health Monitoring

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Posas, Paula J., E-mail: pjposas@gmail.co

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,more » 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.« less

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

PubMed

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

2015-10-31

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

Development of a Maternal, Newborn and Child mHealth Intervention in Thai Nguyen Province, Vietnam: Protocol for the mMom Project

PubMed Central

McBride, Bronwyn; Nguyen, Liem Thanh; Wiljer, David; Vu, Nguyen C; Nguyen, Cuong K

2018-01-01

Background Ethnic minority women (EMW) living in mountainous areas of northern Vietnam have disproportionately high infant and maternal mortality rates as a result of low maternal health knowledge, poverty, and remoteness from low-capacity health centers. Objective The objective of this study was to describe the protocol for the development and evaluation of the mMom intervention, which is an integrated mobile health (mHealth) system designed to improve maternal and infant health knowledge, and behavior among women in remote areas of Thai Nguyen, Vietnam. Methods This project featured the following four phases: (1) development of an mHealth platform integrated into the existing health management information system in partnership with the provincial health department; (2) ethnographic fieldwork and intervention content development; (3) intervention piloting and implementation; and (4) evaluation of the intervention’s impact on participants’ maternal health knowledge, behavior, and interactions with the health system. Results The mMom project development process resulted in the following: (1) the successful development of the mMom system, including the mHealth platform hardware and integration, the intervention plan and content, and the monitoring and evaluation framework; (2) the piloting and implementation of the intervention as planned; and (3) the implementation of the monitoring and evaluation framework components. Conclusions This protocol outlines the development of the mMom intervention and describes critical next steps in understanding the impact of the intervention on participants and the wider health system in Thai Nguyen province, Vietnam. PMID:29326095

A two-state comparative implementation of peer-support intervention to link veterans to health-related services after incarceration: a study protocol.

PubMed

Simmons, Molly M; Fincke, Benjamin G; Drainoni, Mari-Lynn; Kim, Bo; Byrne, Tom; Smelson, David; Casey, Kevin; Ellison, Marsha L; Visher, Christy; Blue-Howells, Jessica; McInnes, D Keith

2017-09-12

Approximately 600,000 persons are released from prison annually in the United States. Relatively few receive sufficient re-entry services and are at risk for unemployment, homelessness, poverty, substance abuse relapse and recidivism. Persons leaving prison who have a mental illness and/or a substance use disorder are particularly challenged. This project aims to create a peer mentor program to extend the reach and effectiveness of reentry services provided by the Department of Veterans' Affairs (VA). We will implement a peer support for reentry veterans sequentially in two states. Our outcome measures are 1) fidelity of the intervention, 2) linkage to VA health care and, 3) continued engagement in health care. The aims for this project are as follows: (1) Conduct contextual analysis to identify VA and community reentry resources, and describe how reentry veterans use them. (2) Implement peer-support, in one state, to link reentry veterans to Veterans' Health Administration (VHA) primary care, mental health, and SUD services. (3) Port the peer-support intervention to another, geographically, and contextually different state. This intervention involves a 2-state sequential implementation study (Massachusetts, followed by Pennsylvania) using a Facilitation Implementation strategy. We will conduct formative and summative analyses, including assessment of fidelity, and a matched comparison group to evaluate the intervention's outcomes of veteran linkage and engagement in VHA health care (using health care utilization measures). The study proceeds in 3 phases. We anticipate that a peer support program will be effective at improving the reentry process for veterans, particularly in linking them to health, mental health, and SUD services and helping them to stay engaged in those services. It will fill a gap by providing veterans with access to a trusted individual, who understands their experience as a veteran and who has experienced justice involvement. The outputs from

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

PubMed Central

2012-01-01

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

Penicillin allergy: optimizing diagnostic protocols, public health implications, and future research needs.

PubMed

Macy, Eric

2015-08-01

Unverified penicillin allergy is being increasingly recognized as a public health concern. The ideal protocol for verifying true clinically significant IgE-mediated penicillin allergy needs to use only commercially available materials, be well tolerated and easy to perform in both the inpatient and outpatient settings, and minimize false-positive determinations. This review concentrates on articles published in 2013 and 2014 that present new data relating to the diagnosis and management of penicillin allergy. Penicillin allergy can be safely evaluated at this time, in patients with an appropriate clinical history of penicillin allergy, using only penicilloyl-poly-lysine and native penicillin G as skin test reagents, if an oral challenge with amoxicillin 250 mg, followed by 1 h of observation, is given to all skin test negative individuals. Millions of individuals falsely labeled with penicillin allergy need to be evaluated to safely allow them to use penicillin-class antibiotics and avoid morbidity associated with penicillin avoidance. Further research is needed to determine optimal protocol(s). There will still be a 1-2% rate of adverse reactions reported with all future therapeutic penicillin-class antibiotic use, even with optimal methods used to determine acute penicillin tolerance. Only a small minority of these new reactions will be IgE-mediated.

Health literacy, health empowerment and health information search in the field of MMR vaccination: a cross-sectional study protocol

PubMed Central

Diviani, Nicola; Camerini, Anne-Linda; Reinholz, Danuta; Galfetti, Alessandra; Schulz, Peter J

2012-01-01

Objectives Although public health offices have a detailed record of the vaccination coverage among adolescents in Switzerland, little is known about the factors that determine the decisions of parents to get their children vaccinated. Based on Schulz & Nakamoto's Extended Health Empowerment Model, the present study aims at surveying parents of adolescents in Ticino (Switzerland) to get insights into the role of health literacy, health empowerment, information search behaviour and potential confounding variables that influence whether adolescents are not at all vaccinated, undervaccinated or fully covered against measles, mumps and rubella (MMR). Methods and analysis A survey including concepts of the Extended Health Empowerment Model will be administered to all families with adolescents attending the third year of middle school in Ticino. Subsequently, survey responses will be matched with actual data on MMR vaccination coverage of adolescents collected from the Cantonal Office of Public Health in Ticino. Discussion The results of this study will allow one to draw more comprehensive conclusions about the factors that play a role in parents’ decisions regarding the vaccination of their children. At the same time, the study will provide useful insights on which are the main issues to be considered when addressing parents (on an interpersonal as well as a mass communication level) regarding the vaccination of their children. PMID:23166139

Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board.

PubMed

Zia, Mohammad I; Heslegrave, Ronald; Newton, Gary E

2011-12-01

The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.

Standards for Environmental Measurement Using GIS: Toward a Protocol for Protocols.

PubMed

Forsyth, Ann; Schmitz, Kathryn H; Oakes, Michael; Zimmerman, Jason; Koepp, Joel

2006-02-01

Interdisciplinary research regarding how the built environment influences physical activity has recently increased. Many research projects conducted jointly by public health and environmental design professionals are using geographic information systems (GIS) to objectively measure the built environment. Numerous methodological issues remain, however, and environmental measurements have not been well documented with accepted, common definitions of valid, reliable variables. This paper proposes how to create and document standardized definitions for measures of environmental variables using GIS with the ultimate goal of developing reliable, valid measures. Inherent problems with software and data that hamper environmental measurement can be offset by protocols combining clear conceptual bases with detailed measurement instructions. Examples demonstrate how protocols can more clearly translate concepts into specific measurement. This paper provides a model for developing protocols to allow high quality comparative research on relationships between the environment and physical activity and other outcomes of public health interest.

A Study of Shared-Memory Mutual Exclusion Protocols Using CADP

NASA Astrophysics Data System (ADS)

Mateescu, Radu; Serwe, Wendelin

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

Development of an HIV Postexposure Prophylaxis (PEP) Protocol for Trainees Engaging in Academic Global Health Experiences.

PubMed

Arora, Gitanjli; Hoffman, Risa M

2017-11-01

Global health (GH) education programs have become increasingly common in U.S. medical schools and graduate medical education programs, with growing numbers of medical students, residents, and fellows participating in clinical experiences in settings with high HIV prevalence and limited resources. However, there are no guidelines for provision of HIV postexposure prophylaxis (PEP) to trainees engaging in these academic GH experiences. Faculty of the Global Health Education Programs (GHEP) at the David Geffen School of Medicine at UCLA and GH partner institutions recognized the need for PEP access for trainees engaged in GH experiences. In 2013-2014, key UCLA faculty collaborated in the development of the UCLA GHEP PEP Protocol, which includes provision of PEP medications to trainees prior to departure, an on-call infectious disease/HIV specialist to advise trainees who have exposures, and a system for following up with exposed trainees while on the GH rotation and after their return. Between February 2014 and September 2016, 112 medical students and 110 residents received education on the PEP protocol during their predeparture orientation. The protocol was used for 28 exposures (27 occupational, 1 nonoccupational), with PEP recommended in 3 occupational cases (all needlesticks) and the single nonoccupational case. There were no reported HIV seroconversions. The authors plan to formally evaluate the PEP protocol, conduct a qualitative assessment with trainees and both UCLA and GH partner faculty, and discuss best practices with institutions across the United States and with GH partners.

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

Comparison of Nutrigenomics Technology Interface Tools for Consumers and Health Professionals: Protocol for a Mixed-Methods Study.

PubMed

Littlejohn, Paula; Cop, Irene; Brown, Erin; Afroze, Rimi; Davison, Karen M

2018-06-11

because they did not complete all required data collection forms or were later found to be ineligible. The final sample (n=55) was mostly female (75%), married (85%), and those who had completed postsecondary education (62%). This study will leverage quantitative and qualitative findings, which will guide the development of nutrigenomics-based products in electronic formats that are user-friendly for consumers and health professionals. Although the quantitative data have not been analyzed yet, the overwhelming interest in the study and the extremely high retention rate show that there is a great degree of interest in this field. Given this interest and the fact that nutrigenomics is an evolving science, a need for continued research exists to further the understanding of the role of genetic variation and its role and applications in nutrition practice. Clinicaltrials.gov NCT03310814; http://clinicaltrials.gov/ct2/show/NCT03310814 (Archived by WebCite at http://www.webcitation.org/6yGnU5deB). RR1-10.2196/9846. ©Paula Littlejohn, Irene Cop, Erin Brown, Rimi Afroze, Karen M Davison. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.06.2018.

The Association of Health Literacy and Electronic Health Literacy With Self-Efficacy, Coping, and Caregiving Perceptions Among Carers of People With Dementia: Research Protocol for a Descriptive Correlational Study.

PubMed

Efthymiou, Areti; Middleton, Nicos; Charalambous, Andreas; Papastavrou, Evridiki

2017-11-13

consistency of the scale as estimated using Cronbach alpha coefficient was .77, somewhat lower than other validation studies. Recruitment of pilot study participants started in May 2017. Carers' eHealth literacy is a new field. Whereas previous studies have focused on the role and impact of low eHealth literacy and health literacy among older adults, the eHealth literacy of carers, and in fact carers of people with dementia, has not been explored. We hypothesize an association between eHealth literacy and health literacy level with carers' perceptions about caregiving role, self-efficacy, and coping strategies. A possible moderator in these associations is the secondary carers' eHealth and health literacy level, which will also be explored. By confirming the above hypotheses, tailored eHealth literacy interventions for carers of people with dementia and their families will be developed as a direct outcome of this research. ©Areti Efthymiou, Nicos Middleton, Andreas Charalambous, Evridiki Papastavrou. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.11.2017.

Protocol for digital intervention for effective health promotion of small children-A cluster randomized trial.

PubMed

Pakarinen, Anni; Flemmich, Magda; Parisod, Heidi; Selänne, Laura; Hamari, Lotta; Aromaa, Minna; Leppänen, Ville; Löyttyniemi, Eliisa; Smed, Jouni; Salanterä, Sanna

2018-03-08

This article introduces the protocol of a study aiming to evaluate the effectiveness of digital WellWe intervention in supporting the participation of families with small children in the promotion of their health. Early childhood is a meaningful period for building a strong base for good health. Parents play a key role in affecting the health behaviour and psychosocial development of their children. A family-centred approach makes it possible to support families' individual health literacy needs and empower them to take actions towards promoting healthier behaviour. However, there are a lack of family-centred digital health interventions intended for parents and their small children. The study is designed as a two-arm cluster, randomized, controlled trial with a 4-month follow-up. The data are being collected from 200 families with a 4-year-old child. Cluster randomization is being performed at the municipality level. Municipalities (N = 4) located in Southwest Finland, comprising child health clinics (N = 15) with their family clients, were randomly allocated to either an intervention (WellWe intervention) or a control group (usual care). The outcome measures include parental self-efficacy for healthy behaviours, mindfulness in parenting and the family-centred approach of the extensive health examination. Data collection is being performed at baseline, after the intervention and at a 4-month follow-up. The results from this study will make it possible to determine whether this new method can be recommended for implementation in child health clinic settings to support the participation of families with small children in promoting their health. © 2018 John Wiley & Sons Ltd.

Understanding breast health awareness in an Arabic culture: qualitative study protocol.

PubMed

Madkhali, Norah Abdullah; Santin, Olinda; Noble, Helen; Reid, Joanne

2016-09-01

To explore breast health awareness and the early diagnosis and detection methods of breast cancer from the perspective of women and primary healthcare providers in the Jizan region of the Kingdom of Saudi Arabia. Although there is a high incidence of advanced breast cancer in young women in the Kingdom of Saudi Arabia, there is no standardized information about breast self-examination, or is there a national screening programme involving clinical breast examination and mammography available. Qualitative exploratory study. Data collection will consist of 36 face-to-face semi-structured interviews: 12 with general practitioners; 12 with nurses at primary healthcare centres and with 12 women who attend the health centres. This study will be carried out in eight states across the Jizan region (four rural and four urban) to reflect the cultural diversity of Jizan. The data will be analysed using thematic content analysis. Research Ethics Committee approval was obtained in June 2015. While we understand the enablers and barriers to breast health awareness outside of Saudi culture, in the Kingdom of Saudi Arabia, particularly in rural populations such as Jizan, there is a lack of research. This study will add positively to the international knowledge base of this topic. The findings will give evidence and inform policy about women and healthcare providers' experiences in Jizan, in a society where such topics are taboo. © 2016 John Wiley & Sons Ltd.

‘Re-engage’ pilot study protocol: a nurse-led eHealth intervention to re-engage, educate and empower childhood cancer survivors

PubMed Central

Wakefield, Claire E; Johnston, Karen A; Fardell, Joanna E; Brierley, Mary-Ellen E; Thornton-Benko, Elysia; Foreman, Tali; Webber, Kate; Wallace, W Hamish; Cohn, Richard J

2018-01-01

Introduction Many childhood cancer survivors are disengaged from cancer-related follow-up care despite being at high risk of treatment-related late effects. Innovative models of long-term follow-up (LTFU) care to manage ongoing treatment-related complications are needed. ‘Re-engage’ is a nurse-led eHealth intervention designed to improve survivors’ health-related self-efficacy, targeted at survivors disengaged from follow-up. Re-engage aims to overcome survivor- and parent-reported barriers to care and ensure survivors receive the care most appropriate to their risk level. Methods and analysis This study will recruit 30 Australian childhood cancer survivors who are not receiving any cancer-related care. Participation involves two online/telephone consultations with a survivorship nurse for medical assessment, a case review, risk stratification and creation of a care plan by a multidisciplinary team of specialists. We will assess the feasibility of implementing ‘Re-engage’ and its acceptability to participants and health professionals involved. The primary outcome will be survivors’ health-related self-efficacy, measured at baseline and 1 and 6 months postintervention. Secondary outcomes will include the effect of ‘Re-engage’ on survivors’ health behaviours and beliefs, engagement in healthcare, information needs and emotional well-being. We will also document the cost per patient to deliver ‘Re-engage’. If Re-engage is acceptable, feasible and demonstrates early efficacy, it may have the potential to empower survivors in coordinating their complex care, improving survivors’ long-term engagement and satisfaction with care. Ideally, it will be implemented into clinical practice to recall survivors lost to follow-up and reduce the ongoing burden of treatment for childhood cancer. Ethics and dissemination The study protocol has been approved by the South Eastern Sydney Local Health District Human Research Ethics Committee (reference number: 16

An oral health intervention for people with serious mental illness (Three Shires Early Intervention Dental Trial): study protocol for a randomised controlled trial.

PubMed

Jones, Hannah F; Adams, Clive E; Clifton, Andrew; Simpson, Jayne; Tosh, Graeme; Liddle, Peter F; Callaghan, Patrick; Yang, Min; Guo, Boliang; Furtado, Vivek

2013-05-29

Oral health is an important part of general physical health and is essential for self-esteem, self-confidence and overall quality of life. There is a well-established link between mental illness and poor oral health. Oral health problems are not generally well recognized by mental health professionals and many patients experience barriers to treatment. This is the protocol for a pragmatic cluster randomised trial that has been designed to fit within standard care. Dental awareness training for care co-ordinators plus a dental checklist for service users in addition to standard care will be compared with standard care alone for people with mental illness. The checklist consists of questions about service users' current oral health routine and condition. Ten Early Intervention in Psychosis (EIP) teams in Nottinghamshire, Derbyshire and Lincolnshire will be cluster randomised (five to intervention and five to standard care) in blocks accounting for location and size of caseload. The oral health of the service users will be monitored for one year after randomisation. Current Controlled Trials ISRCTN63382258.

Identifying and prioritising systematic review topics with public health stakeholders: A protocol for a modified Delphi study in Switzerland to inform future research agendas.

PubMed

Hoekstra, Dyon; Mütsch, Margot; Kien, Christina; Gerhardus, Ansgar; Lhachimi, Stefan K

2017-08-04

The Cochrane Collaboration aims to produce relevant and top priority evidence that responds to existing evidence gaps. Hence, research priority setting (RPS) is important to identify which potential research gaps are deemed most important. Moreover, RPS supports future health research to conform both health and health evidence needs. However, studies that are prioritising systematic review topics in public health are surprisingly rare. Therefore, to inform the research agenda of Cochrane Public Health Europe (CPHE), we introduce the protocol of a priority setting study on systematic review topics in several European countries, which is conceptualised as pilot. We will conduct a two-round modified Delphi study in Switzerland, incorporating an anonymous web-based questionnaire, to assess which topics should be prioritised for systematic reviews in public health. In the first Delphi round public health stakeholders will suggest relevant assessment criteria and potential priority topics. In the second Delphi round the participants indicate their (dis)agreement to the aggregated results of the first round and rate the potential review topics with the predetermined criteria on a four-point Likert scale. As we invite a wide variety of stakeholders we will compare the results between the different stakeholder groups. We have received ethical approval from the ethical board of the University of Bremen, Germany (principal investigation is conducted at the University of Bremen) and a certificate of non-objection from the Canton of Zurich, Switzerland (fieldwork will be conducted in Switzerland). The results of this study will be further disseminated through peer reviewed publication and will support systematic review author groups (i.a. CPHE) to improve the relevance of the groups´ future review work. Finally, the proposed priority setting study can be used as a framework by other systematic review groups when conducting a priority setting study in a different context. �

Dietary phytochemical intake from foods and health outcomes: a systematic review protocol and preliminary scoping.

PubMed

Probst, Yasmine C; Guan, Vivienne X; Kent, Katherine

2017-02-15

Dietary phytochemicals are found in plant-based foods such as fruits, vegetables and grains and may be categorised in a nested hierarchical manner with many hundred individual phytochemicals identified to date. To associate phytochemical intakes with positive health outcomes, a fundamental step is to accurately estimate the dietary phytochemical intake from foods reported. The purpose of this systematic review protocol is to describe the process to be undertaken to summarise the evidence for food-based dietary phytochemical intakes and health outcomes for adults. The review will be undertaken following the PRISMA guidelines and the Cochrane Handbook for Systematic Reviews of Interventions using the Review Manager software. Phytochemical subclasses (phenolic acids, flavanols, etc) will be used to search for relevant studies using the Web of Science and Scopus scientific databases. The retrieved studies will be screened based on inclusion of natural whole food items and health outcomes. Phytochemical studies related to cardiovascular disease, cancer, overweight, glucose tolerance, digestive, reproductive, macular and bone health and mental disorders, fatigue and immunity will be examined based on prior scoping. The evidence will be aggregated by the food types and health outcomes. Comparison of differences in the outcomes for randomised controlled trials and observational studies will be undertaken. The strength of the review lies in its focus on whole food items and health conditions rather than one type of phytochemical related to one single health condition. Subgroup and sensitivity analyses will be conducted where an adequate number of publications are found per phytochemical subclass. By comparing the outcomes from experimental and observational studies, the review will determine whether the overall conclusions related to the phytochemical subclasses are the same between study types for the identified health conditions. This is useful to public health

Protocol for project IMPACT (improving millions hearts for provider and community transformation): a quasi-experimental evaluation of an integrated electronic health record and community health worker intervention study to improve hypertension management among South Asian patients.

PubMed

Lopez, Priscilla M; Zanowiak, Jennifer; Goldfeld, Keith; Wyka, Katarzyna; Masoud, Ahmad; Beane, Susan; Kumar, Rashi; Laughlin, Phoebe; Trinh-Shevrin, Chau; Thorpe, Lorna; Islam, Nadia

2017-12-06

The Million Hearts® initiative aims to prevent heart disease and stroke in the United States by mobilizing public and private sectors around a core set of objectives, with particular attention on improving blood pressure control. South Asians in particular have disproportionately high rates of hypertension and face numerous cultural, linguistic, and social barriers to accessing healthcare. Interventions utilizing Health information technology (HIT) and community health worker (CHW)-led patient coaching have each been demonstrated to be effective at advancing Million Hearts® goals, yet few studies have investigated the potential impact of integrating these strategies into a clinical-community linkage initiative. Building upon this initiative, we present the protocol and preliminary results of a research study, Project IMPACT, designed to fill this gap in knowledge. Project IMPACT is a stepped wedge quasi-experimental study designed to test the feasibility, adoption, and impact of integrating CHW-led health coaching with electronic health record (EHR)-based interventions to improve hypertension control among South Asian patients in New York City primary care practices. EHR intervention components include the training and implementation of hypertension-specific registry reports, alerts, and order sets. Fidelity to the EHR intervention is assessed by collecting the type, frequency, and utilization of intervention components for each practice. CHW intervention components consist of health coaching sessions on hypertension and related risk factors for uncontrolled hypertensive patients. The outcome, hypertension control (<140 mmHg systolic blood pressure (BP) and <90 mmHg diastolic BP), is collected at the aggregate- and individual-level for all 16 clinical practices enrolled. Project IMPACT builds upon the evidence base of the effectiveness of CHW and Million Hearts® initiatives and proposes a unique integration of provider-based EHR and community-based CHW

'Re-engage' pilot study protocol: a nurse-led eHealth intervention to re-engage, educate and empower childhood cancer survivors.

PubMed

Signorelli, Christina; Wakefield, Claire E; Johnston, Karen A; Fardell, Joanna E; Brierley, Mary-Ellen E; Thornton-Benko, Elysia; Foreman, Tali; Webber, Kate; Wallace, W Hamish; Cohn, Richard J

2018-04-12

Many childhood cancer survivors are disengaged from cancer-related follow-up care despite being at high risk of treatment-related late effects. Innovative models of long-term follow-up (LTFU) care to manage ongoing treatment-related complications are needed. 'Re-engage' is a nurse-led eHealth intervention designed to improve survivors' health-related self-efficacy, targeted at survivors disengaged from follow-up. Re-engage aims to overcome survivor- and parent-reported barriers to care and ensure survivors receive the care most appropriate to their risk level. This study will recruit 30 Australian childhood cancer survivors who are not receiving any cancer-related care. Participation involves two online/telephone consultations with a survivorship nurse for medical assessment, a case review, risk stratification and creation of a care plan by a multidisciplinary team of specialists. We will assess the feasibility of implementing 'Re-engage' and its acceptability to participants and health professionals involved. The primary outcome will be survivors' health-related self-efficacy, measured at baseline and 1 and 6 months postintervention. Secondary outcomes will include the effect of 'Re-engage' on survivors' health behaviours and beliefs, engagement in healthcare, information needs and emotional well-being. We will also document the cost per patient to deliver 'Re-engage'. If Re-engage is acceptable, feasible and demonstrates early efficacy, it may have the potential to empower survivors in coordinating their complex care, improving survivors' long-term engagement and satisfaction with care. Ideally, it will be implemented into clinical practice to recall survivors lost to follow-up and reduce the ongoing burden of treatment for childhood cancer. The study protocol has been approved by the South Eastern Sydney Local Health District Human Research Ethics Committee (reference number: 16/366). The results will be disseminated in peer-reviewed journals and at scientific

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

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

PubMed

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

2015-01-01

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. 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. 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 broader themes across the

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

PubMed

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

2017-03-01

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

Environment and Health in Children Day Care Centres (ENVIRH) - Study rationale and protocol.

PubMed

Araújo-Martins, J; Carreiro Martins, P; Viegas, J; Aelenei, D; Cano, M M; Teixeira, J P; Paixão, P; Papoila, A L; Leiria-Pinto, P; Pedro, C; Rosado-Pinto, J; Annesi-Maesano, I; Neuparth, N

2014-01-01

Indoor air quality (IAQ) is considered an important determinant of human health. The association between exposure to volatile organic compounds, particulate matter, house dust mite, molds and bacteria in day care centers (DCC) is not completely clear. The aim of this project was to study these effects. This study comprised two phases. Phase I included an evaluation of 45 DCCs (25 from Lisbon and 20 from Oporto, targeting 5161 children). In this phase, building characteristics, indoor CO2 and air temperature/relative humidity, were assessed. A children's respiratory health questionnaire derived from the ISAAC (International Study on Asthma and Allergies in Children) was also distributed. Phase II encompassed two evaluations and included 20 DCCs selected from phase I after a cluster analysis (11 from Lisbon and 9 from Oporto, targeting 2287 children). In this phase, data on ventilation, IAQ, thermal comfort parameters, respiratory and allergic health, airway inflammation biomarkers, respiratory virus infection patterns and parental and child stress were collected. In Phase I, building characteristics, occupant behavior and ventilation surrogates were collected from all DCCs. The response rate of the questionnaire was 61.7% (3186 children). Phase II included 1221 children. Association results between DCC characteristics, IAQ and health outcomes will be provided in order to support recommendations on IAQ and children's health. A building ventilation model will also be developed. This paper outlines methods that might be implemented by other investigators conducting studies on the association between respiratory health and indoor air quality at DCC. Copyright © 2013 Sociedade Portuguesa de Pneumologia. Published by Elsevier España. All rights reserved.

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

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

PubMed

Paradies, Yin; Priest, Naomi; Ben, Jehonathan; Truong, Mandy; Gupta, Arpana; Pieterse, Alex; Kelaher, Margaret; Gee, Gilbert

2013-09-23

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. 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. This review aims to examine associations between reported racism and health outcomes. This comprehensive and systematic review and meta-analysis of empirical research will provide a rigorous and

Protocol Coordinator | Center for Cancer Research

Cancer.gov

diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator II: Provides comprehensive clinical and administrative support to the Brain Tumor Trial Collaborative, Neuro-Oncology Branch, NCI, National Institutes of Health Serves as a liaison with Principal Investigators (PIs), the associated study teams and a variety of offices associated with protocol development and approvals Orchestrates meetings with investigators and other key medical staff to identify required support Coordinates the writing and regulatory review processes that occur in tandem, facilitates the bi-directional dialogue and feedback between various teams, and assists investigators and medical writers on the production/revision of clinical research protocols Assists research staff in coordinating/navigating requirements for special circumstances and facilitates access to necessary services Facilitates initiation of intramural research by providing assistance in obtaining required approvals Coordinates with investigators and medical writers to ensure Institutional Review Board (IRB) and Food and Drug Administration (FDA) stipulations are appropriately addressed in a timely manner Provides consultation and assistance for all aspects of the protocol lifecycle including initial Investigational New Drug (IND) submission, IRB submission, continuing review applications, protocol amendments, annual reports, and protocol inactivation with IRB and FDA Tracks a portfolio of protocols through each lifecycle step; processes and tracks appropriate approvals (e.g., IRB, Data and Safety Monitoring Board, Radiation Safety, Office of Protocol Services, etc.) Provides

Application of a motivation-behavioral skills protocol in gingival lichen planus: a short-term study.

PubMed

López-Jornet, Pia; Camacho-Alonso, Fabio

2010-10-01

The main objective of the present study was to assess the efficacy of a motivation–behavioral skills protocol for plaque control in patients with gingival lichen planus. A pre- and post-test descriptive clinical study was made of 40 consecutive white patients with gingival lichen planus: five males (12.5%) and 35 females (87.5%); mean age: 57 years. A motivation–behavioral skills protocol for oral hygiene was applied, with the determination of gingival scores (gingival index, plaque extension, and Community Periodontal Index of Treatment Needs [CPITN]) and patient evaluation after 4 and 8 weeks. The clinical parameters in relation to the different forms of gingival lichen planus showed statistically significant improvements for gingival index, plaque extension, and CPITN (P <0.001) as determined 4 and 8 weeks after starting the program. The application of an active prevention program in patients with gingival lichen planus is important because it offers benefits for periodontal health. However, more long-term studies are needed to confirm the results obtained.

Developing a framework for community-based sexual health interventions for youth in the rural setting: protocol for a participatory action research study

PubMed Central

Heslop, Carl William; Burns, Sharyn; Lobo, Roanna; McConigley, Ruth

2017-01-01

Introduction There is limited research examining community-based or multilevel interventions that address the sexual health of young people in the rural Australian context. This paper describes the Participatory Action Research (PAR) project that will develop and validate a framework that is effective for planning, implementing and evaluating multilevel community-based sexual health interventions for young people aged 16–24 years in the Australian rural setting. Methods and analysis To develop a framework for sexual health interventions with stakeholders, PAR will be used. Three PAR cycles will be conducted, using semistructured one-on-one interviews, focus groups, community mapping and photovoice to inform the development of a draft framework. Cycle 2 and Cycle 3 will use targeted Delphi studies to gather evaluation and feedback on the developed draft framework. All data collected will be reviewed and analysed in detail and coded as concepts become apparent at each stage of the process. Ethics and dissemination This protocol describes a supervised doctoral research project. This project seeks to contribute to the literature regarding PAR in the rural setting and the use of the Delphi technique within PAR projects. The developed framework as a result of the project will provide a foundation for further research testing the application of the framework in other settings and health areas. This research has received ethics approval from the Curtin University Human Research and Ethics Committee (HR96/2015). PMID:28559453

An in silico method to identify computer-based protocols worthy of clinical study: An insulin infusion protocol use case

PubMed Central

Wong, Anthony F; Pielmeier, Ulrike; Haug, Peter J; Andreassen, Steen

2016-01-01

Objective Develop an efficient non-clinical method for identifying promising computer-based protocols for clinical study. An in silico comparison can provide information that informs the decision to proceed to a clinical trial. The authors compared two existing computer-based insulin infusion protocols: eProtocol-insulin from Utah, USA, and Glucosafe from Denmark. Materials and Methods The authors used eProtocol-insulin to manage intensive care unit (ICU) hyperglycemia with intravenous (IV) insulin from 2004 to 2010. Recommendations accepted by the bedside clinicians directly link the subsequent blood glucose values to eProtocol-insulin recommendations and provide a unique clinical database. The authors retrospectively compared in silico 18 984 eProtocol-insulin continuous IV insulin infusion rate recommendations from 408 ICU patients with those of Glucosafe, the candidate computer-based protocol. The subsequent blood glucose measurement value (low, on target, high) was used to identify if the insulin recommendation was too high, on target, or too low. Results Glucosafe consistently provided more favorable continuous IV insulin infusion rate recommendations than eProtocol-insulin for on target (64% of comparisons), low (80% of comparisons), or high (70% of comparisons) blood glucose. Aggregated eProtocol-insulin and Glucosafe continuous IV insulin infusion rates were clinically similar though statistically significantly different (Wilcoxon signed rank test P = .01). In contrast, when stratified by low, on target, or high subsequent blood glucose measurement, insulin infusion rates from eProtocol-insulin and Glucosafe were statistically significantly different (Wilcoxon signed rank test, P < .001), and clinically different. Discussion This in silico comparison appears to be an efficient nonclinical method for identifying promising computer-based protocols. Conclusion Preclinical in silico comparison analytical framework allows rapid and inexpensive

System-wide analysis of health financing equity in Cambodia: a study protocol

PubMed Central

Wiseman, Virginia; Asante, Augustine; Ir, Por; Limwattananon, Supon; Jacobs, Bart; Liverani, Marco; Hayen, Andrew; Jan, Stephen

2017-01-01

Background To assess progress towards universal health coverage, countries like Cambodia require evidence on equity in the financing and distribution of healthcare benefits. This evidence must be based on a system-wide perspective that recognises the complex roles played by the public and private sectors in many contemporary healthcare systems. Objective To undertake a system-wide assessment of who pays and who benefits from healthcare in Cambodia and to understand the factors influencing this. Methods Financing and benefit incidence analysis will be used to calculate the financing burden and distribution of healthcare benefits across socioeconomic groups. Data on healthcare usage, living standards and self-assessed health status will be derived from a cross-sectional household survey designed for this study involving a random sample of 5000 households. This will be supplemented by secondary data from the Cambodian National Health Accounts 2014 and the Cambodian Socioeconomic Survey (CSES) 2014. We will also collect qualitative data through focus group discussions and in-depth interviews to inform the interpretation of the quantitative analyses. Potential impact This study will produce previously unavailable information on who pays for, and who benefits from, health services across the entire health system of Cambodia. This evidence comes at a critical juncture in healthcare reform in South-East Asia with so many countries seeking guidance on the equity impact of their current financing arrangements that include a complex mix of public and private providers. PMID:28589000

Protocol: A grounded theory of 'recovery'-perspectives of adolescent users of mental health services.

PubMed

Palmquist, Lucianne; Patterson, Sue; O'Donovan, Analise; Bradley, Graham

2017-07-20

Policies internationally endorse the recovery paradigm as the appropriate foundation for youth mental health services. However, given that this paradigm is grounded in the views of adults with severe mental illness, applicability to youth services and relevance to young people is uncertain, particularly as little is known about young people's views. A comprehensive understanding of the experiences and expectations of young people is critical to developing youth mental health services that are acceptable, accessible, effective and relevant. To inform development of policy and youth services, the study described in this protocol aims to develop a comprehensive account of the experiences and expectations of 12-17 year olds as they encounter mental disorders and transition through specialist mental health services. Data will be analysed to model recovery from the adolescents' perspective. This grounded theory study will use quantitative and qualitative data collected in interviews with 12-17 year olds engaged with specialist Child/Youth Mental Health Service in Queensland, Australia. Interviews will explore adolescents' expectations and experiences of mental disorder, and of services, as they transition through specialist mental health services, including the meaning of their experiences and ideas of 'recovery' and how their experiences and expectations are shaped. Data collection and analysis will use grounded theory methods. Adolescents' experiences will be presented as a mid-range theory. The research will provide tangible recommendations for youth-focused mental health policy and practice. Findings will be disseminated within academic literature and beyond to participants, health professionals, mental health advocacy groups and policy and decision makers via publications, research summaries, conferences and workshops targeting different audiences. Ethical and research governance approvals have been obtained from relevant Human Research Ethics committees and all

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

Development of an HPV Educational Protocol for Adolescents

PubMed Central

Wetzel, Caitlin; Tissot, Abbigail; Kollar, Linda M.; Hillard, Paula A.; Stone, Rachel; Kahn, Jessica A.

2007-01-01

Study Objectives To develop an educational protocol about HPV and Pap tests for adolescents, to evaluate the protocol for understandability and clarity, and to evaluate the protocol for its effectiveness in increasing knowledge about HPV. Design In phase 1, investigators and adolescents developed the protocol. In phase 2, adolescents evaluated the protocol qualitatively, investigators evaluated its effectiveness in increasing HPV knowledge in a sample of adolescents, and the protocol was revised. In phase 3, investigators evaluated the effectiveness of the revised protocol in an additional adolescent sample. Setting Urban, hospital-based teen health center. Participants A total of 252 adolescent girls and boys in the three study phases. Main Outcome Measures Pre- and post-protocol knowledge about HPV, measured using a 10- or 11-item scale. Results Scores on the HPV knowledge scale increased significantly (p<.0001) among adolescents who participated in phases 2 and 3 after they received the protocol. Initial differences in scores based on race, insurance type and condom use were not noted post-protocol. Conclusion The protocol significantly increased knowledge scores about HPV in this population, regardless of sociodemographic characteristics and risk behaviors. Effective, developmentally appropriate educational protocols about HPV and Pap tests are particularly important in clinical settings as cervical cancer screening guidelines evolve, HPV DNA testing is integrated into screening protocols, and HPV vaccines become available. In-depth, one-on-one education about HPV may also prevent adverse psychosocial responses and promote healthy sexual and Pap screening behaviors in adolescents with abnormal HPV or Pap test results. Synopsis The investigators developed an educational protocol about HPV and Pap tests and evaluated its effectiveness in increasing knowledge about HPV among adolescents. PMID:17868894

Study protocol for One Health data collections, analyses and intervention of the Sino-Swedish integrated multisectoral partnership for antibiotic resistance containment (IMPACT)

PubMed Central

Sun, Qiang; Wang, Yang; Hulth, Anette; Xiao, Yonghong; Nilsson, Lennart E; Li, Xuewen; Bi, Zhenwang; Liu, Yuqing; Yin, Hong; Luo, Yanbo; Nilsson, Maud; Sun, Chengtao; Zhu, Yiqing; Zheng, Beiwen; Chen, Baoli; Sun, Pan; Ding, Lilu; Xia, Xi; Ottoson, Jakob; Löfmark, Sonja; Dyar, Oliver James; Börjesson, Stefan; Lundborg, Cecilia Stalsby

2018-01-01

Introduction To effectively minimise the emergence and dissemination of antibiotic resistant bacteria, a holistic One Health approach is called for. The Sino-Swedish Integrated Multisectoral Partnership for Antibiotic Resistance Containment is a cross-sectoral and integrated project on antibiotic resistance, conducted in Shandong Province in China. This paper outlines the overall study protocol for the project. To our knowledge, this is the first research programme aiming to take a true holistic approach across multiple sectors simultaneously in China, and the first to incorporate both antibiotic use and infection prevention and control in addition to antibiotic resistance patterns. The project aims to address gaps in current knowledge and seeks to improve the situation through a system-wide intervention. By using a One Health approach we can address important research questions that individual discipline investigations are unable to. The results obtained should thus more closely reflect the world in which human health, animal health and the environment are inextricably and intimately interlinked. Methods and analysis Both quantitative and qualitative studies are included for households from 12 villages, their surrounding environment and a tertiary care hospital in a nearby town. The studies include analyses of antibiotic consumption for humans and pigs; qualitative and quantitative data on perceptions, knowledge and attitudes; faecal carriage of extended spectrum β-lactamase and carbapenemase-producing Enterobacteriaceae from pigs and humans, and occurrence in household drinking water, surface water, waste water and clinical bacterial isolates from the hospital. Carriage of methicillin-resistant Staphylococcus aureus in humans, household pigs and clinical bacterial isolates is also investigated. Furthermore, potential inter-relationships between these sources are analysed. A multifaceted One Health intervention is designed and implemented in 6 of the 12 villages

Improving Health-Related Quality of Life of Patients With an Ostomy Using a Novel Digital Wearable Device: Protocol for a Pilot Study.

PubMed

Rouholiman, Dara; Gamble, Jamison G; Dobrota, Sylvie D; Encisco, Ellen M; Shah, Ashish G; Grajales Iii, Francisco J; Chu, Larry F

2018-03-26

studies have demonstrated decreased health-related quality of life in patients with an ostomy bag. We aim to examine the extent to which the Ostom-i alert sensor affects the health-related quality of life of its users. The Ostom-i alert sensor has the potential to improve quality of life of users by giving them the freedom and confidence to partake in daily activities with the knowledge that they can check how full their ostomy bag is in a private, discrete manner. ClinicalTrials.gov NCT02319434; https://clinicaltrials.gov/ct2/show/NCT02319434 (Archived at WebCite at http://www.webcitation.org/6xhFDThmq). ©Dara Rouholiman, Jamison G Gamble, Sylvie D Dobrota, Ellen M Encisco, Ashish G Shah, Francisco J Grajales III, Larry F Chu. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.03.2018.

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

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

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

PubMed

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

2014-02-14

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. 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 be extracted using

Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study.

PubMed

Park, Linda G; Collins, Eileen G; Shim, Janet K; Whooley, Mary A

2017-07-18

Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT). We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports. Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence. ClinicalTrials.gov NCT03022669. ©Linda G Park, Eileen G Collins, Janet K

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

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

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

PubMed

Campo Osaba, Maria-Antonia; Del Val, José-Luis; Lapena, Carolina; Laguna, Vicencia; García, Araceli; Lozano, Olga; Martín, Ziortza; Rodriguez, Rómulo; Borrás, Enriqueta; Orfila, Francesc; Tierno, María Teresa

2012-03-19

The promotion of health and the interventions in community health continue to be one of the pending subjects of our health system. The most prevalent health problems (cardiovascular diseases, cancer, diabetes...) are for the most part related to life habits. We propose a holistic and integral approach as the best option for tackling behavior and its determinants. The research team has elaborated the necessary educational material to realize group teaching, which we call "Health Workshops". The goal of the present study is to evaluate the effectiveness of these Health Workshops in the following terms: Health Related Quality of Life (HRQOL), incorporate and maintain a balanced diet, do physical activity regularly, maintain risk factors such as tension, weight, cholesterol within normal limits and diminish cardiovascular risk. Controlled and random clinical testing, comparing a group of persons who have participated in the Health Workshops with a control group of similar characteristics who have not participated in the Health Workshops.Field of study: the research is being done in Health Centers of the city of Barcelona, Spain. The group is composed of 108 persons that are actually doing the Health Workshops, and 108 that are not and form the control group. They are assigned at random to one group or the other. With Student's t-distribution test to compare the differences between numerical variables or their non parametric equivalent if the variable does not comply with the criteria of normality. (Kolmogorov-Smirnof test). Chi-square test to compare the differences between categorical variables and the Logistic Regression Model to analyze different meaningful variables by dichotomous analysis related to the intervention. The Health Workshop proposed in the present study constitutes an innovative approach in health promotion, placing the emphasis on the person's self responsibility for his/her own health.The rhythm of a weekly session during 8 weeks with recommended

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.

Study protocol for a longitudinal study evaluating the impact of rape on women's health and their use of health services in South Africa.

PubMed

Abrahams, Naeemah; Seedat, Soraya; Lombard, Carl; Kengne, Andre P; Myers, Bronwyn; Sewnath, Alesha; Mhlongo, Shibe; Ramjee, Gita; Peer, Nasheeta; Garcia-Moreno, Claudia; Jewkes, Rachel

2017-09-29

South Africa is a country known for its high levels of HIV infection and sexual violence. Although the interface between gender-based violence, HIV and mental health has been described, there are substantial gaps in knowledge of the medium-term and long-term health impact. The 2010 Global Burden of Disease study excluded many health outcomes associated with rape and other forms of gender-based violence because systematic reviews revealed huge gaps in data and poor evidence of health effects. This study aims to describe the incidence and attributable burden of physical and mental health problems (including HIV acquisition) in adult women over a 2-year postrape period, through comparison with a cohort of women who have not been raped. The study will substantially advance our understanding of the impact of rape and will generate robust data to assist in the development of postrape health services and the delivery of evidence-based care. This longitudinal study seeks to recruit 1008 rape-exposed and 1008 rape non-exposed women. Women were recruited from health services, and assessments were carried out at baseline, 3, 6, 9, 12, 18 and 24 months. Outcome measures include exposure to risk factors; mental health status; cardio-metabolic risks; and biomarkers for HIV, sexually transmitted infections, pregnancy and stress. The primary analysis will be to compare HIV incidence in the two groups using log-rank tests. Appropriate models to predict health outcomes over time will also be applied. The South African Medical Research Council's Ethics Committee approved the study. As rape is a key element of the study, the safety and protection of participants guides the research process. We will adopt a research uptake strategy to ensure dissemination to policy makers, service providers and advocacy groups. Peer-reviewed journal articles will be published. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No

Study protocol for the recruitment of female sex workers and their non-commercial partners into couple-based HIV research.

PubMed

Syvertsen, Jennifer L; Robertson, Angela M; Abramovitz, Daniela; Rangel, M Gudelia; Martinez, Gustavo; Patterson, Thomas L; Ulibarri, Monica D; Vera, Alicia; El-Bassel, Nabila; Strathdee, Steffanie A

2012-02-20

Researchers are increasingly recognizing the importance of addressing sexual and drug-related HIV risk within the context of intimate relationships rather than solely focusing on individual behaviors. Practical and effective methods are needed to recruit, screen, and enroll the high risk and hard-to-reach couples who would most benefit from HIV interventions, such as drug-using female sex workers (FSWs) and their intimate, non-commercial partners. This paper outlines a bi-national, multidisciplinary effort to develop and implement a study protocol for research on the social context and epidemiology of HIV, sexually transmitted infections (STI), and high risk behaviors among FSWs and their non-commercial male partners in Tijuana and Ciudad Juarez, Mexico. We provide an overview of our study and specifically focus on the sampling, recruitment, screening, and successful enrollment of high risk couples into a public health study in this context. We used targeted and snowball sampling to recruit couples through the female partner first and administered a primary screener to check her initial eligibility. Willing and eligible females then invited their primary male partners for couple-based screening using a couple verification screening (CVS) instrument adapted from previous studies. The CVS rechecked eligibility and separately asked each partner the same questions about their relationship to "test" if the couple was legitimate. We adapted the original protocol to consider issues of gender and power within the local cultural and socioeconomic context and expanded the question pool to create multiple versions of the CVS that were randomly administered to potential couples to determine eligibility and facilitate study enrollment. The protocol successfully enrolled 214 high risk couples into a multi-site public health study. This work suggests the importance of collaborating to construct a study protocol, understanding the local population and context, and drawing on

Analysis of Security Protocols for Mobile Healthcare.

PubMed

Wazid, Mohammad; Zeadally, Sherali; Das, Ashok Kumar; Odelu, Vanga

2016-11-01

Mobile Healthcare (mHealth) continues to improve because of significant improvements and the decreasing costs of Information Communication Technologies (ICTs). mHealth is a medical and public health practice, which is supported by mobile devices (for example, smartphones) and, patient monitoring devices (for example, various types of wearable sensors, etc.). An mHealth system enables healthcare experts and professionals to have ubiquitous access to a patient's health data along with providing any ongoing medical treatment at any time, any place, and from any device. It also helps the patient requiring continuous medical monitoring to stay in touch with the appropriate medical staff and healthcare experts remotely. Thus, mHealth has become a major driving force in improving the health of citizens today. First, we discuss the security requirements, issues and threats to the mHealth system. We then present a taxonomy of recently proposed security protocols for mHealth system based on features supported and possible attacks, computation cost and communication cost. Our detailed taxonomy demonstrates the strength and weaknesses of recently proposed security protocols for the mHealth system. Finally, we identify some of the challenges in the area of security protocols for mHealth systems that still need to be addressed in the future to enable cost-effective, secure and robust mHealth systems.

Investigating the nature of interprofessional collaboration in primary care across the Western Health Region of Brasília, Brazil: A study protocol.

PubMed

Pinho, Diana; Parreira, Clelia; Queiroz, Elizabeth; Abbad, Gardênia; Reeves, Scott

2018-03-01

Primary care can provide a supportive context for the development of interprofessional collaborative practice owing to its nature and dynamics. In Brazil, a number of practice changes have already occurred to primary care, notably the implementation of the Family Health Strategy which promoted interprofessional collaboration (IPC). In Brasilia, a new arrangement was implemented in 2016 that focused on an expansion of primary healthcare. However, it is not clear how these reforms will affect the nature of IPC or the delivery of patient care. The article presents a study protocol which describes a study that aims to explore the nature of IPC in the context of primary care in the Western Health Region of Brasilia. A sequential mixed methods design will be used to gather both quantitative and qualitative data. Initially, we will translate, cross-culturally adapt, and validate an IPC scale for a survey of primary care teams. We will then undertake a series of focus groups with a purposeful sample of team members to explore the results from the survey. Quantitative data will be analysed with descriptive and multivariate statistics. A content analysis will be undertaken with the focus group data. We expect that the results will illuminate a range of elements linked to IPC in primary care as well as identify areas for improving IPC skills, patient safety, quality of care, and healthcare outcomes in this clinical context.

Effective knowledge translation approaches and practices in Indigenous health research: a systematic review protocol.

PubMed

Morton Ninomiya, Melody E; Atkinson, Donna; Brascoupé, Simon; Firestone, Michelle; Robinson, Nicole; Reading, Jeff; Ziegler, Carolyn P; Maddox, Raglan; Smylie, Janet K

2017-02-20

Effective knowledge translation (KT) is critical to implementing program and policy changes that require shared understandings of knowledge systems, assumptions, and practices. Within mainstream research institutions and funding agencies, systemic and insidious inequities, privileges, and power relationships inhibit Indigenous peoples' control, input, and benefits over research. This systematic review will examine literature on KT initiatives in Indigenous health research to help identify wise and promising Indigenous KT practices and language in Canada and abroad. Indexed databases including Aboriginal Health Abstract Database, Bibliography of Native North Americans, CINAHL, Circumpolar Health Bibliographic Database, Dissertation Abstracts, First Nations Periodical Index, Medline, National Indigenous Studies Portal, ProQuest Conference Papers Index, PsycInfo, Social Services Abstracts, Social Work Abstracts, and Web of Science will be searched. A comprehensive list of non-indexed and grey literature sources will also be searched. For inclusion, documents must be published in English; linked to Indigenous health and wellbeing; focused on Indigenous people; document KT goals, activities, and rationale; and include an evaluation of their KT strategy. Identified quantitative, qualitative, and mixed methods' studies that meet the inclusion criteria will then be appraised using a quality appraisal tool for research with Indigenous people. Studies that score 6 or higher on the quality appraisal tool will be included for analysis. This unique systematic review involves robust Indigenous community engagement strategies throughout the life of the project, starting with the development of the review protocol. The review is being guided by senior Indigenous researchers who will purposefully include literature sources characterized by Indigenous authorship, community engagement, and representation; screen and appraise sources that meet Indigenous health research principles

Parental intimate partner homicide and its consequences for children: protocol for a population-based study.

PubMed

Alisic, Eva; Groot, Arend; Snetselaar, Hanneke; Stroeken, Tielke; van de Putte, Elise

2015-07-29

The loss of a parent due to intimate partner homicide has a major impact on children. Professionals involved have to make far-reaching decisions regarding placement, guardianship, mental health care and contact with the perpetrating parent, without an evidence base to guide these decisions. We introduce a study protocol to a) systematically describe the demographics, circumstances, mental health and wellbeing of children bereaved by intimate partner homicide and b) build a predictive model of factors associated with children's mental health and wellbeing after intimate partner homicide. This study focuses on children bereaved by parental intimate partner homicide in the Netherlands over a period of 20 years (1993 - 2012). It involves an incidence study to identify all Dutch intimate partner homicide cases between 1993 and 2012 by which children have been bereaved; systematic case reviews to describe the demographics, circumstances and care trajectories of these children; and a mixed-methods study to assess mental health, wellbeing, and experiences regarding decisions made and care provided. Clinical experience and initial research suggest that the children involved often need long-term intensive mental health and case management. The costs of these services are extensive and the stakes are high. This study lays the foundation for an international dataset and evidence-informed decision making.

Realist Evaluation of the Use of Patient Experience Data to Improve the Quality of Inpatient Mental Health Care (EURIPIDES) in England: study protocol.

PubMed

Weich, Scott; Fenton, Sarah-Jane Hannah; Bhui, Kamaldeep; Staniszewska, Sophie; Madan, Jason; Larkin, Michael; Newton, Elizabeth; Crepaz-Keay, David; Canaway, Alastair; Croft, Charlotte; Griffiths, Frances

2018-06-14

Inpatient mental healthcare continues to be an area of high risk and where patients report negative experiences. To ensure the patient voice is heard, National Health Service (NHS) Trusts are required to collect feedback from patients routinely. We do not know what kinds of feedback are most important or what management processes are needed to translate this into effective action plans. Further, we do not know if this makes any difference to the patients themselves. This study seeks to explore which of the many different approaches to collecting and using patient experience data are the most useful for supporting improvements in inpatient mental healthcare. The overarching aim of the study is to arrive at recommendations for best practice in the collection and use of patient experience data in NHS England adult inpatient mental health settings. We present the protocol for Realist Evaluation of the Use of Patient Experience Data to Improve the Quality of Inpatient Mental Health Care study (EURIPIDES). The study is composed of five work packages (WPs), including a systematic review of patient experiences (WP1); a telephone survey to assist the selection of case sites (WP2); six indepth case studies involving interviews with service users, carers and staff to enable a realist evaluation of the use of patient experience to improve quality in adult inpatient mental health services (WP3); an economic evaluation of patient experience feedback activity (WP5); and a consensus conference (WP4). We discuss the methodological rationale for the five WPs. This study has received approval from West Midlands/South Birmingham NHS Research Ethics Committee. The outcome of the consensus conference meeting (WP4) will form the basis of the outputs to be disseminated to NHS providers. Dissemination will also take place through publications and presentations at relevant conferences. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All

The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial.

PubMed

Rombeek, Meghan; De Jesus, Stefanie; Altamirano-Diaz, Luis; Welisch, Eva; Prapavessis, Harry; Seabrook, Jamie A; Norozi, Kambiz

2017-01-01

Both obesity and congenital heart disease (CHD) are risk factors for the long-term cardiovascular health of children and adolescents. The addition of smart mobile technology to conventional lifestyle counseling for weight management offers great potential to appeal to technologically literate youth and can address a large geographical area with minimal burden to participants. This pilot study seeks to examine the influence of a 1-year lifestyle intervention on nutrition and physical activity-related health outcomes in overweight or obese children and adolescents with CHD. This is a pilot and feasibility study which utilizes a single-arm, prospective design with a goal to recruit 40 overweight and obese patients. The feasibility metrics will evaluate the integrity of the study protocol, data collection and questionnaires, recruitment and consent, and acceptability of the intervention protocol and primary outcome measures. The primary clinical outcome metrics are anthropometry, body composition, and cardiorespiratory exercise capacity. The secondary clinical metrics include quality of life, nutrition and physical activity behavior, lung and muscle function, and cardio-metabolic risk factors. Outcomes are assessed at baseline, 6 months, and 1 year. To date, a total of 36 children and youth (11 girls), aged 7-17 years (mean = 14.4 years), have commenced the intervention. Recruitment for the study was initiated in June 2012 and is currently ongoing. The information provided in this paper is intended to help researchers and health professionals with the development and evaluation of similar lifestyle intervention programs. Since the application of smartphones to pediatric cardiac health and obesity management is a novel approach, and continued research in this area is warranted, this paper may serve as a foundation for further exploration of this health frontier and inform the development of a broader strategy for obesity management in pediatric cardiology. This

Effects and meanings of a person-centred and health-promoting intervention in home care services - a study protocol of a non-randomised controlled trial.

PubMed

Bölenius, Karin; Lämås, Kristina; Sandman, Per-Olof; Edvardsson, David

2017-02-16

The literature indicates that current home care service are largely task oriented with limited focus on the involvement of the older people themselves, and studies show that lack of involvement might reduce older people's quality of life. Person-centred care has been shown to improve the satisfaction with care and quality of life in older people cared for in hospitals and nursing homes, with limited published evidence about the effects and meanings of person-centred interventions in home care services for older people. This study protocol outlines a study aiming to evaluate such effects and meanings of a person-centred and health-promoting intervention in home aged care services. The study will take the form of a non-randomised controlled trial with a before/after approach. It will include 270 older people >65 years receiving home care services, 270 relatives and 65 staff, as well as a matched control group of equal size. All participants will be recruited from a municipality in northern Sweden. The intervention is based on the theoretical concepts of person-centredness and health-promotion, and builds on the four pedagogical phases of: theory apprehension, experimental learning, operationalization, and clinical supervision. Outcome assessments will focus on: a) health and quality of life (primary outcomes), thriving and satisfaction with care for older people; b) caregiver strain, informal caregiving engagement and relatives' satisfaction with care: c) job satisfaction and stress of conscience among care staff (secondary outcomes). Evaluation will be conducted by means of self-reported questionnaires and qualitative research interviews. Person-centred home care services have the potential to improve the recurrently reported sub-standard experiences of home care services, and the results can point the way to establishing a more person-centred and health-promoting model for home care services for older people. NCT02846246 .

Policy to implementation: evidence-based practice in community mental health--study protocol.

PubMed

Beidas, Rinad S; Aarons, Gregory; Barg, Frances; Evans, Arthur; Hadley, Trevor; Hoagwood, Kimberly; Marcus, Steven; Schoenwald, Sonja; Walsh, Lucia; Mandell, David S

2013-03-24

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. 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 sample to assess the

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

PubMed Central

Agot, Kawango

2017-01-01

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

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...

Accelerated Storage Stability and Corrosion Characteristics Study Protocol

EPA Pesticide Factsheets

EPA has determined that studies using this protocol will, in certain circumstances, provide the Agency with all the information it needs to make a determination on the storage stability of pesticides.

Study protocol for a longitudinal study evaluating the impact of rape on women’s health and their use of health services in South Africa

PubMed Central

Seedat, Soraya; Lombard, Carl; Kengne, Andre P; Myers, Bronwyn; Sewnath, Alesha; Mhlongo, Shibe; Ramjee, Gita; Peer, Nasheeta; Garcia-Moreno, Claudia; Jewkes, Rachel

2017-01-01

Introduction South Africa is a country known for its high levels of HIV infection and sexual violence. Although the interface between gender-based violence, HIV and mental health has been described, there are substantial gaps in knowledge of the medium-term and long-term health impact. The 2010 Global Burden of Disease study excluded many health outcomes associated with rape and other forms of gender-based violence because systematic reviews revealed huge gaps in data and poor evidence of health effects. This study aims to describe the incidence and attributable burden of physical and mental health problems (including HIV acquisition) in adult women over a 2-year postrape period, through comparison with a cohort of women who have not been raped. The study will substantially advance our understanding of the impact of rape and will generate robust data to assist in the development of postrape health services and the delivery of evidence-based care. Methods and analysis This longitudinal study seeks to recruit 1008 rape-exposed and 1008 rape non-exposed women. Women were recruited from health services, and assessments were carried out at baseline, 3, 6, 9, 12, 18 and 24 months. Outcome measures include exposure to risk factors; mental health status; cardio-metabolic risks; and biomarkers for HIV, sexually transmitted infections, pregnancy and stress. The primary analysis will be to compare HIV incidence in the two groups using log-rank tests. Appropriate models to predict health outcomes over time will also be applied. Ethics and dissemination The South African Medical Research Council’s Ethics Committee approved the study. As rape is a key element of the study, the safety and protection of participants guides the research process. We will adopt a research uptake strategy to ensure dissemination to policy makers, service providers and advocacy groups. Peer-reviewed journal articles will be published. PMID:28965098

42 CFR 438.352 - External quality review protocols.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false External quality review protocols. 438.352 Section... SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS MANAGED CARE External Quality Review § 438.352 External quality review protocols. Each protocol must specify— (a) The data to be gathered; (b) The sources of the...

Household preferences for reducing greenhouse gas emissions in four European high-income countries: Does health information matter? A mixed-methods study protocol.

PubMed

Herrmann, Alina; Fischer, Helen; Amelung, Dorothee; Litvine, Dorian; Aall, Carlo; Andersson, Camilla; Baltruszewicz, Marta; Barbier, Carine; Bruyère, Sébastien; Bénévise, Françoise; Dubois, Ghislain; Louis, Valérie R; Nilsson, Maria; Richardsen Moberg, Karen; Sköld, Bore; Sauerborn, Rainer

2017-08-01

It is now universally acknowledged that climate change constitutes a major threat to human health. At the same time, some of the measures to reduce greenhouse gas emissions, so-called climate change mitigation measures, have significant health co-benefits (e.g., walking or cycling more; eating less meat). The goal of limiting global warming to 1,5° Celsius set by the Conference of the Parties to the United Nations Framework Convention on Climate Change in Paris in 2015 can only be reached if all stakeholders, including households, take actions to mitigate climate change. Results on whether framing mitigation measures in terms of their health co-benefits increases the likelihood of their implementation are inconsistent. The present study protocol describes the transdisciplinary project HOPE (HOuseholds' Preferences for reducing greenhouse gas emissions in four European high-income countries) that investigates the role of health co-benefits in households' decision making on climate change mitigation measures in urban households in France, Germany, Norway and Sweden. HOPE employs a mixed-methods approach combining status-quo carbon footprint assessments, simulations of the reduction of households' carbon footprints, and qualitative in-depth interviews with a subgroup of households. Furthermore, a policy analysis of current household oriented climate policies is conducted. In the simulation of the reduction of households' carbon footprints, half of the households are provided with information on health co-benefits of climate change mitigation measures, the other half is not. Households' willingness to implement the measures is assessed and compared in between-group analyses of variance. This is one of the first comprehensive mixed-methods approaches to investigate which mitigation measures households are most willing to implement in order to reach the 1,5° target set by the Paris Agreement, and whether health co-benefits can serve as a motivator for households to

Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

PubMed

Cerritelli, Francesco; Cicchitti, Luca; Martelli, Marta; Barlafante, Gina; Renzetti, Cinzia; Pizzolorusso, Gianfranco; Lupacchini, Mariacristina; D'Orazio, Marianna; Marinelli, Benedetta; Cozzolino, Vincenzo; Fusilli, Paola; D'Incecco, Carmine

2015-03-08

Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy

A comparative study of wireless sensor networks and their routing protocols.

PubMed

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.

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.

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol.

PubMed

Hensel, Kendi L; Carnes, Michael S; Stoll, Scott T

2016-11-01

The structural and physiologic changes in a woman's body during pregnancy can predispose pregnant women to low back pain and its associated disability, as well as to complications of pregnancy, labor, and delivery. Anecdotal and empirical evidence has indicated that osteopathic manipulative treatment (OMT) may be efficacious in improving pain and functionality in women who are pregnant. Based on that premise, the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was designed as a prospective, randomized, placebo-controlled, and blinded clinical trial to evaluate the efficacy of an OMT protocol for pain during third-trimester pregnancy. The OMT protocol developed for the PROMOTE study was based on physiologic theory and the concept of the interrelationship of structure and function. The 12 well-defined, standardized OMT techniques used in the protocol are commonly taught at osteopathic medical schools in the United States. These techniques can be easily replicated as a 20-minute protocol applied in conjunction with usual prenatal care, thus making it feasible to implement into clinical practice. This article presents an overview of the study design and treatment protocols used in the PROMOTE study.

21 CFR 312.83 - Treatment protocols.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Treatment protocols. 312.83 Section 312.83 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR...-debilitating Illnesses § 312.83 Treatment protocols. If the preliminary analysis of phase 2 test results...

21 CFR 312.83 - Treatment protocols.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Treatment protocols. 312.83 Section 312.83 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR...-debilitating Illnesses § 312.83 Treatment protocols. If the preliminary analysis of phase 2 test results...

21 CFR 312.83 - Treatment protocols.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Treatment protocols. 312.83 Section 312.83 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR...-debilitating Illnesses § 312.83 Treatment protocols. If the preliminary analysis of phase 2 test results...

[Proposal of an Italian national protocol of health surveillance for former asbestos workers: an ongoing project].

PubMed

Marchiori, Luciano; Marangi, Gianluca; Ballarin, Nicoletta; Valentini, Flavio; D'Anna, Mauro; Barbina, Paolo; Franchi, Alberto; Mastrangelo, Giuseppe

2016-01-01

to define an Italian national protocol of post-occupational health surveillance for asbestos workers according to effectiveness, appropriateness, saving, and social utility. data for 1,071 former asbestos workers from several Italian Regions were collected and analysed. For these workers, a retrospective estimate of asbestos exposure was carried out. A cohort study of 1,588 asbestos workers recruited from 2000 onward during statutory health examinations in Veneto and followed-up for lung cancer mortality until December 2010 was executed. A literature search on methods of follow-up of asbestos workers (imaging, spirometry, and questionnaires) and diagnosis of non-malignant (asbestosis and pleural plaques) and malignant (lung cancer) asbestos disease was done. A consensus, i.e., a process of agreeing on one result among the participants, was made. 19 Italian Regions (North: Veneto, Emilia-Romagna, Lombardia, Piemonte, Valle d'Aosta, Autonomous Province of Trento, Autonomous Province of Bolzano, Friuli Venezia Giulia, Liguria; Centre:Toscana, Umbria; South and Islands: Calabria, Abruzzo, Puglia, Campania, Basilicata,Marche, Sicilia, Sardegna), Department of Occupational Medicine at Italian National Institute for Compensation ofWork-Related Diseases and Accidents (INAIL), and Department of Cardiac, Thoracic, and Vascular Sciences at University of Padova. analysis of current regional experiences on health surveillance; retrospective estimate of asbestos exposure; data collection and analysis of a cohort of asbestos workers; search of the relevant literature; final report with the consensus document. the results obtained in each of the above areas of research, along with the relevant findings of the literature, were presented and discussed among the participants. The several phases of expression and evaluation of the participants' opinions were conducted according to an iterative method of investigation (Delphi method), which allows a progressive converging of different

Health surveillance under adverse ergonomics conditions--validity of a screening method adapted for the occupational health service.

PubMed

Jonker, Dirk; Gustafsson, Ewa; Rolander, Bo; Arvidsson, Inger; Nordander, Catarina

2015-01-01

A new health surveillance protocol for work-related upper-extremity musculoskeletal disorders has been validated by comparing the results with a reference protocol. The studied protocol, Health Surveillance in Adverse Ergonomics Conditions (HECO), is a new version of the reference protocol modified for application in the Occupational Health Service (OHS). The HECO protocol contains both a screening part and a diagnosing part. Sixty-three employees were examined. The screening in HECO did not miss any diagnosis found when using the reference protocol, but in comparison to the reference protocol considerable time savings could be achieved. Fair to good agreement between the protocols was obtained for one or more diagnoses in neck/shoulders (86%, k = 0.62) and elbow/hands (84%, k = 0.49). Therefore, the results obtained using the HECO protocol can be compared with a reference material collected with the reference protocol, and thus provide information of the magnitude of disorders in an examined work group. Practitioner Summary: The HECO protocol is a relatively simple physical examination protocol for identification of musculoskeletal disorders in the neck and upper extremities. The protocol is a reliable and cost-effective tool for the OHS to use for occupational health surveillance in order to detect workplaces at high risk for developing musculoskeletal disorders.

Study protocol for One Health data collections, analyses and intervention of the Sino-Swedish integrated multisectoral partnership for antibiotic resistance containment (IMPACT).

PubMed

Sun, Qiang; Wang, Yang; Hulth, Anette; Xiao, Yonghong; Nilsson, Lennart E; Li, Xuewen; Bi, Zhenwang; Liu, Yuqing; Yin, Hong; Luo, Yanbo; Nilsson, Maud; Sun, Chengtao; Zhu, Yiqing; Zheng, Beiwen; Chen, Baoli; Sun, Pan; Ding, Lilu; Xia, Xi; Ottoson, Jakob; Löfmark, Sonja; Dyar, Oliver James; Börjesson, Stefan; Lundborg, Cecilia Stalsby

2018-01-21

To effectively minimise the emergence and dissemination of antibiotic resistant bacteria, a holistic One Health approach is called for. The Sino-Swedish Integrated Multisectoral Partnership for Antibiotic Resistance Containment is a cross-sectoral and integrated project on antibiotic resistance, conducted in Shandong Province in China. This paper outlines the overall study protocol for the project. To our knowledge, this is the first research programme aiming to take a true holistic approach across multiple sectors simultaneously in China, and the first to incorporate both antibiotic use and infection prevention and control in addition to antibiotic resistance patterns. The project aims to address gaps in current knowledge and seeks to improve the situation through a system-wide intervention. By using a One Health approach we can address important research questions that individual discipline investigations are unable to. The results obtained should thus more closely reflect the world in which human health, animal health and the environment are inextricably and intimately interlinked. Both quantitative and qualitative studies are included for households from 12 villages, their surrounding environment and a tertiary care hospital in a nearby town. The studies include analyses of antibiotic consumption for humans and pigs; qualitative and quantitative data on perceptions, knowledge and attitudes; faecal carriage of extended spectrum β-lactamase and carbapenemase-producing Enterobacteriaceae from pigs and humans, and occurrence in household drinking water, surface water, waste water and clinical bacterial isolates from the hospital. Carriage of methicillin-resistant Staphylococcus aureus in humans, household pigs and clinical bacterial isolates is also investigated. Furthermore, potential inter-relationships between these sources are analysed. A multifaceted One Health intervention is designed and implemented in 6 of the 12 villages. Repeated and continuous data

SABE Colombia: Survey on Health, Well-Being, and Aging in Colombia—Study Design and Protocol

PubMed Central

Corchuelo, Jairo; Curcio, Carmen-Lucia; Calzada, Maria-Teresa; Mendez, Fabian

2016-01-01

Objective. To describe the design of the SABE Colombia study. The major health study of the old people in Latin America and the Caribbean (LAC) is the Survey on Health, Well-Being, and Aging in LAC, SABE (from initials in Spanish: SAlud, Bienestar & Envejecimiento). Methods. The SABE Colombia is a population-based cross-sectional study on health, aging, and well-being of elderly individuals aged at least 60 years focusing attention on social determinants of health inequities. Methods and design were similar to original LAC SABE. The total sample size of the study at the urban and rural research sites (244 municipalities) was 23.694 elderly Colombians representative of the total population. The study had three components: (1) a questionnaire covering active aging determinants including anthropometry, blood pressure measurement, physical function, and biochemical and hematological measures; (2) a subsample survey among family caregivers; (3) a qualitative study with gender and cultural perspectives of quality of life to understand different dimensions of people meanings. Conclusions. The SABE Colombia is a comprehensive, multidisciplinary study of the elderly with respect to active aging determinants. The results of this study are intended to inform public policies aimed at tackling health inequalities for the aging society in Colombia. PMID:27956896

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

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

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

2014-10-30

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. 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. 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 (NOMS) approved: 2013-257. Published by the BMJ Publishing

The Dutch complementary and alternative medicine (CAM) protocol: to ensure the safe and effective use of complementary and alternative medicine within Dutch mental health care.

PubMed

Hoenders, H J Rogier; Appelo, Martin T; van den Brink, Erik H; Hartogs, Bregje M A; de Jong, Joop T V M

2011-12-01

Complementary and alternative medicine (CAM) is subject to heated debates and prejudices. Studies show that CAM is widely used by psychiatric patients, usually without the guidance of a therapist and without the use of a solid working method, leading to potential health risks. The purpose of this study is to facilitate the judicious use of CAM alongside conventional psychiatry in an outpatient psychiatric clinic. A search was made through scientific and legal articles and discussion in focus groups. In the Centre for Integrative Psychiatry (CIP) of Lentis in The Netherlands, some carefully selected CAM are offered under strict conditions, alongside conventional treatments. Because of the controversy and the potential health risks, Lentis designed a protocol that is presented. The CIP hopes, by using this protocol, to better serve and respect the individual needs and preferences of the diversity of psychiatric patients in our Dutch multicultural society, and better protect them from harm.

Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial.

PubMed

Templeman, Iain; Thompson, Dylan; Gonzalez, Javier; Walhin, Jean-Philippe; Reeves, Sue; Rogers, Peter J; Brunstrom, Jeffrey M; Karagounis, Leonidas G; Tsintzas, Kostas; Betts, James A

2018-02-02

Prior studies have shown that intermittent fasting is capable of producing improvements in body weight and fasted health markers. However, the extent to which intermittent fasting incurs compensatory changes in the components of energy balance and its impact on postprandial metabolism are yet to be ascertained. A total of 30-36 lean participants and 30-36 overweight/obese participants will be recruited to provide two separate study groups who will undergo the same protocol. Following an initial assessment of basic anthropometry and key health markers, measurements of habitual energy intake (weighed food and fluid intake) and physical activity energy expenditure (combined heart rate and accelerometry) will be obtained over 4 weeks under conditions of energy balance. Participants will then be randomly allocated to one of three experimental conditions for 20 days, namely (1) daily calorie restriction (reduce habitual daily energy intake by 25%), (2) intermittent fasting with calorie restriction (alternate between 24-hour periods of fasting and feeding to 150% of habitual daily energy intake), (3) intermittent fasting without calorie restriction (alternate between 24-hour periods of fasting and feeding to 200% of habitual daily energy intake). In addition to continued monitoring of energy intake and physical activity during the intervention, participants will report for laboratory-based assessments of various metabolic parameters both before and after the intervention. Specifically, fasting and postprandial measurements of resting metabolic rate, substrate oxidation, appetite, food preference, and plasma concentrations of key metabolites and hormones will be made, in addition to subcutaneous abdominal adipose tissue biopsies in the fasted state and an assessment of body composition via dual-energy x-ray absorptiometry. Comparing observed changes in these measures across the three intervention arms in each group will establish the impact of intermittent fasting on

Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols

PubMed Central

Kyte, Derek; Duffy, Helen; Fletcher, Benjamin; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; King, Madeleine; Draper, Heather; Ives, Jonathan; Brundage, Michael; Blazeby, Jane; Calvert, Melanie

2014-01-01

Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully

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

McLean, Robert K D; Graham, Ian D; Bosompra, Kwadwo; Choudhry, Yumna; Coen, Stephanie E; Macleod, Martha; Manuel, Christopher; McCarthy, Ryan; Mota, Adrian; Peckham, David; Tetroe, Jacqueline M; Tucker, Joanne

2012-06-22

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. 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. 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 best be evaluated.

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

Developing protocols for obstetric emergencies.

PubMed

Roth, Cheryl K; Parfitt, Sheryl E; Hering, Sandra L; Dent, Sarah A

2014-01-01

There is potential for important steps to be missed in emergency situations, even in the presence of many health care team members. Developing a clear plan of response for common emergencies can ensure that no tasks are redundant or omitted, and can create a more controlled environment that promotes positive health outcomes. A multidisciplinary team was assembled in a large community hospital to create protocols that would help ensure optimum care and continuity of practice in cases of postpartum hemorrhage, shoulder dystocia, emergency cesarean surgical birth, eclamptic seizure and maternal code. Assignment of team roles and responsibilities led to the evolution of standardized protocols for each emergency situation. © 2014 AWHONN.

Study protocol and overview of the literature on long-term health and quality of life outcomes in patients treated in adolescence for scoliosis with therapeutic exercises.

PubMed

Plaszewski, Maciej; Kotwicki, Tomasz; Chwala, Wieslaw; Terech, Jacek; Cieśliński, Igor

2015-01-01

Scoliosis, the most prevalent orthopaedic condition affecting children and adolescents, may have lasting physical, psychological and social consequences. With limited evidence-base, scoliosis-specific exercise therapies are an option. An overview of the subject and description of a long-term follow-up study including adults who in adolescence were treated with a scoliosis-specific exercise programme investigating the association of the exercise regime with present physical activity, physical functioning and subjective wellbeing. To the authors' best knowledge, this is the first long-term outcome study on scoliosis-specific exercises, in opposition to a number of studies in adults who were braced or treated surgically in adolescence. Observational, registry-based case-control study. Adult subjects who in adolescence were treated with an exercise programme or were under observation are invited. Spine and trunk deformity, respiratory function, physical capacity and trunk muscles' function are measured. Health-related quality of life with generic and condition-specific instruments, general mental health, depression and anxiety symptoms, disability due to low back problems and physical activity are assessed. The report is believed to provide the readers with an overview of this controversial aspect of rehabilitation, and that the proposed protocol will assist researchers designing their studies.

Toward a bioethical framework for antibiotic use, antimicrobial resistance and for empirically designing ethically robust strategies to protect human health: a research protocol

PubMed Central

Martins Pereira, Sandra; de Sá Brandão, Patrícia Joana; Araújo, Joana; Carvalho, Ana Sofia

2017-01-01

Introduction Antimicrobial resistance (AMR) is a challenging global and public health issue, raising bioethical challenges, considerations and strategies. Objectives This research protocol presents a conceptual model leading to formulating an empirically based bioethics framework for antibiotic use, AMR and designing ethically robust strategies to protect human health. Methods Mixed methods research will be used and operationalized into five substudies. The bioethical framework will encompass and integrate two theoretical models: global bioethics and ethical decision-making. Results Being a study protocol, this article reports on planned and ongoing research. Conclusions Based on data collection, future findings and using a comprehensive, integrative, evidence-based approach, a step-by-step bioethical framework will be developed for (i) responsible use of antibiotics in healthcare and (ii) design of strategies to decrease AMR. This will entail the analysis and interpretation of approaches from several bioethical theories, including deontological and consequentialist approaches, and the implications of uncertainty to these approaches. PMID:28459355

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

PubMed

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

2018-01-01

The Singapore General Hospital Burns Protocol was implemented in May 2014 to standardize treatment for all burns patients, incorporate new techniques and materials, and streamline the processes and workflow of burns management. This study aims to analyze the effects of the Burns Protocol 2 years after its implementation. Using a REDCap electronic database, all burns patients admitted from May 2013 to April 2016 were included in the study. The historical preimplementation control group composed of patients admitted from May 2013 to April 2014 (n = 96). The postimplementation prospective study cohort consisted of patients admitted from May 2014 to April 2016 (n = 243). Details of the patients collected included age, sex, comorbidities, total body surface area (TBSA) burns, time until surgery, number of surgeries, number of positive tissue and blood cultures, and length of hospital stay. There was no statistically significant difference in the demographics of both groups. The study group had a statistically significant shorter time to surgery compared with the control group (20.8 vs 38.1, P < 0.0001). The study group also averaged fewer surgeries performed (1.96 vs 2.29, P = 0.285), which, after accounting for the extent of burns, was statistically significant (number of surgeries/TBSA, 0.324 vs 0.506; P = 0.0499). The study group also had significantly shorter length of stay (12.5 vs 16.8, P = 0.0273), a shorter length of stay/TBSA burns (0.874 vs 1.342, P = 0.0101), and fewer positive tissue cultures (0.6 vs 1.3, P = 0.0003). The study group also trended toward fewer positive blood culture results (0.09 vs 0.35, P = 0.0593), although the difference was just shy of statistical significance. The new Singapore General Hospital Burns Protocol had revolutionized Singapore burns care by introducing a streamlined, multidisciplinary burns management, resulting in improved patient outcomes, lowered health care costs, and improved system resource use.

Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial.

PubMed

Jack, Darby W; Asante, Kwaku Poku; Wylie, Blair J; Chillrud, Steve N; Whyatt, Robin M; Ae-Ngibise, Kenneth A; Quinn, Ashlinn K; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

2015-09-22

Household air pollution exposure is a major health risk, but validated interventions remain elusive. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .

A literature review: polypharmacy protocol for primary care.

PubMed

Skinner, Mary

2015-01-01

The purpose of this literature review is to critically evaluate published protocols on polypharmacy in adults ages 65 and older that are currently used in primary care settings that may potentially lead to fewer adverse drug events. A review of OVID, CINAHL, EBSCO, Cochrane Library, Medline, and PubMed databases was completed using the following key words: protocol, guideline, geriatrics, elderly, older adult, polypharmacy, and primary care. Inclusion criteria were: articles in medical, nursing, and pharmacology journals with an intervention, protocol, or guideline addressing polypharmacy that lead to fewer adverse drug events. Qualitative and quantitative studies were included. Exclusion criteria were: publications prior to the year 1992. A gap exists in the literature. No standardized protocol for addressing polypharmacy in the primary care setting was found. Mnemonics, algorithms, clinical practice guidelines, and clinical strategies for addressing polypharmacy in a variety of health care settings were found throughout the literature. Several screening instruments for use in primary care to assess potentially inappropriate prescription of medications in the elderly, such as the Beers Criteria and the STOPP screening tool, were identified. However, these screening instruments were not included in a standardized protocol to manage polypharmacy in primary care. Polypharmacy in the elderly is a critical problem that may result in adverse drug events such as falls, hospitalizations, and increased expenditures for both the patient and the health care system. No standardized protocols to address polypharmacy specific to the primary care setting were identified in this review of the literature. Given the growing population of elderly in this country and the high number of medications they consume, it is critical to focus on the utilization of a standardized protocol to address the potential harm of polypharmacy in the primary care setting and evaluate its effects on

A pilot study of health and wellness coaching for fibromyalgia.

PubMed

Hackshaw, Kevin V; Plans-Pujolras, Marcal; Rodriguez-Saona, Luis E; Moore, Margaret A; Jackson, Erika K; Sforzo, Gary A; Buffington, C A Tony

2016-11-08

The purpose of this study was to test the hypothesis that a health and wellness coaching (HWC)-based intervention for fibromyalgia (FM) would result in sustained improvements in health and quality of life, and reductions in health care utilization. Nine female subjects meeting American College of Rheumatology criteria for a diagnosis of primary FM were studied. The HWC protocol had two components, which were delivered telephonically over a twelve-month period. First, each patient met individually with a coach during the 12 month study at the patient's preference of schedule and frequency (Range:22-32 × 45-min sessions). Coaches were health professionals trained in health and wellness coaching tasks, knowledge, and skills. Second, each patient participated in bimonthly (first six months) and monthly (second six months) group classes on self-coaching strategies during the 12 month study. Prior to the intervention, and after 6 months and 12 months of coaching, the Revised Fibromyalgia Impact Questionnaire (FIQR) was used to measure health and quality of life, and the Brief Pain Inventory-Short Form (BPI) was used to measure pain intensity and interference with function. Total and rheumatology-related health encounters were documented using electronic medical records. Data were analyzed using repeated measures ANOVA. All nine patients finished the HWC protocol. FIQR scores improved by 35 % (P = 0.001). BPI scores decreased by 32 % overall (P = 0.006), 31 % for severity (P = 0.02), and 44 % for interference (P = 0.006). Health care utilization declined by 86 % (P = 0.006) for total and 78 % (P < 0.0001) for rheumatology-related encounters. The HWC program added to standard FM therapy produced clinically significant improvements in quality of life measures (FIQR), pain (BPI), and marked reductions in health care utilization. Such improvements do not typically occur spontaneously in FM patients, suggesting that HWC deserves further

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

PubMed

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

2017-03-08

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

Implementation of a protocol proposed by the Brazilian National Health Surveillance Agency for antibiotic use in very low birth weight infants.

PubMed

Pinto, Maria Cristina F Guedes; Bueno, Arnaldo C; Vieira, Alan A

2013-01-01

To analyze the implementation of a protocol proposed by the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA) to improve sepsis diagnosis in very low birth weight newborns. This was a prospective study that evaluated the implementation of a protocol involving clinical and laboratory criteria (hematologic scoring system of Rodwell and C-reactive protein serial measurements), recommended by ANVISA, to improve the diagnosis of neonatal sepsis in very low birth weight newborns. The study included all patients who were born and remained in the neonatal intensive care unit until discharge or death, and excluded those with congenital diseases. The main outcomes measured in newborns before (2006-2007) and after implementation of the protocol (2008) were the rates of early and late-onset sepsis, use of antibiotics, and mortality. Means were compared by Student's t-test and categorical variables were compared by the chi-squared test; the significance level for all tests was set at 95%. The study included 136 newborns with very low birth weight. There was no difference between groups regarding general clinical characteristics in the studied periods. There was, however, a decrease in the number of diagnoses of probable early-onset sepsis (p<0.001), use of antimicrobial regimens (p<0.001), and overall mortality and infection-related mortality (p=0.009 and p=0.049, respectively). The implementation of the protocol allowed improvement of sepsis diagnosis by reducing the diagnosis of probable early-onset sepsis, thus promoting efficient antimicrobial use in this population. Copyright © 2013 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

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

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

2016-08-23

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. 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. 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, presented to funders and relevant local

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

PubMed

Ricciardelli, Lina A; Mellor, David; McCabe, Marita P; Mussap, Alexander J; Hallford, David J; Tyler, Matthew

2012-01-11

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

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

PubMed Central

2012-01-01

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

Study protocol for the recruitment of female sex workers and their non-commercial partners into couple-based HIV research

PubMed Central

2012-01-01

Background Researchers are increasingly recognizing the importance of addressing sexual and drug-related HIV risk within the context of intimate relationships rather than solely focusing on individual behaviors. Practical and effective methods are needed to recruit, screen, and enroll the high risk and hard-to-reach couples who would most benefit from HIV interventions, such as drug-using female sex workers (FSWs) and their intimate, non-commercial partners. This paper outlines a bi-national, multidisciplinary effort to develop and implement a study protocol for research on the social context and epidemiology of HIV, sexually transmitted infections (STI), and high risk behaviors among FSWs and their non-commercial male partners in Tijuana and Ciudad Juarez, Mexico. We provide an overview of our study and specifically focus on the sampling, recruitment, screening, and successful enrollment of high risk couples into a public health study in this context. Methods/Design We used targeted and snowball sampling to recruit couples through the female partner first and administered a primary screener to check her initial eligibility. Willing and eligible females then invited their primary male partners for couple-based screening using a couple verification screening (CVS) instrument adapted from previous studies. The CVS rechecked eligibility and separately asked each partner the same questions about their relationship to "test" if the couple was legitimate. We adapted the original protocol to consider issues of gender and power within the local cultural and socioeconomic context and expanded the question pool to create multiple versions of the CVS that were randomly administered to potential couples to determine eligibility and facilitate study enrollment. Discussion The protocol successfully enrolled 214 high risk couples into a multi-site public health study. This work suggests the importance of collaborating to construct a study protocol, understanding the local

eLearning for health system leadership and management capacity building: a protocol for a systematic review

PubMed Central

Tudor Car, Lorainne; Atun, Rifat

2017-01-01

Introduction Health leadership and management capacity are essential for health system strengthening and for attaining universal health coverage by optimising the existing human, technological and financial resources. However, in health systems, health leadership and management training is not widely available. The use of information technology for education (ie, eLearning) could help address this training gap by enabling flexible, efficient and scalable health leadership and management training. We present a protocol for a systematic review on the effectiveness of eLearning for health leadership and management capacity building in improving health system outcomes. Methodology and analysis We will follow the Cochrane Collaboration methodology. We will search for experimental studies focused on the use of any type of eLearning modality for health management and leadership capacity building in all types of health workforce cadres. The primary outcomes of interest will be health outcomes, financial risk protection and user satisfaction. In addition, secondary outcomes of interest include the attainment of health system objectives of improved equity, efficiency, effectiveness and responsiveness. We will search relevant databases of published and grey literature as well as clinical trials registries from 1990 onwards without language restrictions. Two review authors will screen references, extract data and perform risk of bias assessment independently. Contingent on the heterogeneity of the collated literature, we will perform either a meta-analysis or a narrative synthesis of the collated data. Ethics and dissemination The systematic review will aim to inform policy makers, investors, health professionals, technologists and educators about the existing evidence, potential gaps in literature and the impact of eLearning for health leadership and management capacity building on health system outcomes. We will disseminate the review findings by publishing it as a peer

Managing the transition (ManTra): a resource for persons with secondary progressive multiple sclerosis and their health professionals: protocol for a mixed-methods study in Italy

PubMed Central

Giordano, Andrea; Pietrolongo, Erika; Confalonieri, Paolo; De Luca, Giovanna; Tortorella, Carla; Trojano, Maria; Messmer Uccelli, Michele; Torri Clerici, Valentina; Gitto, Lara; Köpke, Sascha; Borreani, Claudia; Heesen, Christoph; Solari, Alessandra

2017-01-01

Introduction 15 years after clinical onset, about 50% of patients with relapsing-remitting multiple sclerosis convert to secondary progressive multiple sclerosis (SPMS). Notwithstanding the importance of this transition, knowledge of the experiences and needs of patients and carers is fragmentary, and targeted interventions are not available. Managing the Transition to SPMS (ManTra) is a mixed methodology project to develop and test a user-led resource for newly diagnosed patients with SPMS. Here, we describe the developmental phase, consisting of a literature review and a new research study involving key stakeholders, in which we construct the resource. Methods and analysis Round 1: The literature review and study will be conducted in parallel. The latter will identify patient needs using a qualitative approach consisting of: personal semistructured interviews with >15 recently diagnosed patients with SPMS; three focus group meetings (one with significant others of patients, one with neurologists and one with other health professionals caring for patients with SPMS). An online survey (>200 recently diagnosed Italian patients with SPMS) will follow to verify needs in a larger independent sample. An expert panel will outline a set of candidate resources/interventions that aim to satisfy the needs thus identified. Round 2: Consensus on the final resource will be obtained in a 1-day meeting of recently diagnosed patients with SPMS, significant others, health professionals and other stakeholders, using the nominal group technique. The expert panel will refine the resource, identify the outcome measures to assess its efficacy and ascertain the most suitable comparator (ManTra Phase 2, not part of this protocol). Ethics and dissemination The study protocol was approved by the ethics committees of each of the involved centres: Foundation IRCCS Neurological Institute C Besta, Milan; G D’Annunzio University of Chieti-Pescara and the Aldo Moro University of Bari. The

The implementation of a new Malaria Treatment Protocol in Timor-Leste: challenges and constraints

PubMed Central

Martins, João Soares; Zwi, Anthony B; Hobday, Karen; Bonaparte, Fernando; Kelly, Paul M

2012-01-01

Background Timor-Leste changed its malaria treatment protocol in 2007, replacing the first-line for falciparum malaria from sulphadoxine-pyrimethamine to artemether-lumefantrine. This study explored the factors affecting the implementation of the revised treatment protocol, with an emphasis on identifying key constraints. Methods A mixed method approach drew on both qualitative and quantitative data. The study included data from District Health Services in seven districts, community health centres in 14 sub-districts, four hospitals, five private clinics, one private pharmacy and the country's autonomous medical store. In-depth interviews with 36 key informants, five group interviews and 15 focus group discussions were conducted. A survey was also undertaken at community health centres and hospitals to assess the availability of a physical copy of the Malaria Treatment Protocol, as well as the availability and utilization of artemether-lumefantrine and sulphadoxine-pyrimethamine. Results Many factors impeded the implementation of the new malaria protocol. These included: inadequate introduction and training around the revised treatment protocol; unclear phasing out of sulphadoxine-pyrimethamine and phasing in of the revised treatment, artemether-lumefantrine, and the rapid diagnostic test (RDT); lack of supervision; lack of adherence to the revised guidelines by foreign health workers; lack of access to the new drug by the private sector; obstacles in the procurement process; and the use of trade names rather than generic drug description. Insufficient understanding of the rapid diagnostic test and the untimely supply of drugs further hampered implementation. Conclusion To effectively implement a revised malaria treatment protocol, barriers should be identified during the policy formulation process and those emerging during implementation should be recognized promptly and addressed. PMID:22460007

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

PubMed Central

2010-01-01

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

Protocol: A grounded theory of ‘recovery’—perspectives of adolescent users of mental health services

PubMed Central

Palmquist, Lucianne; Patterson, Sue; O'Donovan, Analise; Bradley, Graham

2017-01-01

Introduction Policies internationally endorse the recovery paradigm as the appropriate foundation for youth mental health services. However, given that this paradigm is grounded in the views of adults with severe mental illness, applicability to youth services and relevance to young people is uncertain, particularly as little is known about young people’s views. A comprehensive understanding of the experiences and expectations of young people is critical to developing youth mental health services that are acceptable, accessible, effective and relevant. Aim To inform development of policy and youth services, the study described in this protocol aims to develop a comprehensive account of the experiences and expectations of 12–17 year olds as they encounter mental disorders and transition through specialist mental health services. Data will be analysed to model recovery from the adolescents’ perspective. Method and analysis This grounded theory study will use quantitative and qualitative data collected in interviews with 12–17 year olds engaged with specialist Child/Youth Mental Health Service in Queensland, Australia. Interviews will explore adolescents’ expectations and experiences of mental disorder, and of services, as they transition through specialist mental health services, including the meaning of their experiences and ideas of ‘recovery’ and how their experiences and expectations are shaped. Data collection and analysis will use grounded theory methods. Ethics and dissemination Adolescents’ experiences will be presented as a mid-range theory. The research will provide tangible recommendations for youth-focused mental health policy and practice. Findings will be disseminated within academic literature and beyond to participants, health professionals, mental health advocacy groups and policy and decision makers via publications, research summaries, conferences and workshops targeting different audiences. Ethical and research governance approvals

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

PubMed

Goicolea, Isabel; Vives-Cases, Carmen; San Sebastian, Miguel; Marchal, Bruno; Kegels, Guy; Hurtig, Anna-Karin

2013-03-23

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. 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. 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 terms of how to trigger such learning

Strategies for research engagement of clinicians in allied health (STRETCH): a mixed methods research protocol.

PubMed

Mickan, Sharon; Wenke, Rachel; Weir, Kelly; Bialocerkowski, Andrea; Noble, Christy

2017-09-11

Allied health professionals (AHPs) report positive attitudes to using research evidence in clinical practice, yet often lack time, confidence and skills to use, participate in and conduct research. A range of multifaceted strategies including education, mentoring and guidance have been implemented to increase AHPs' use of and participation in research. Emerging evidence suggests that knowledge brokering activities have the potential to support research engagement, but it is not clear which knowledge brokering strategies are most effective and in what contexts they work best to support and maintain clinicians' research engagement. This protocol describes an exploratory concurrent mixed methods study that is designed to understand how allied health research fellows use knowledge brokering strategies within tailored evidence-based interventions, to facilitate research engagement by allied health clinicians. Simultaneously, a realist approach will guide a systematic process evaluation of the research fellows' pattern of use of knowledge brokering strategies within each case study to build a programme theory explaining which knowledge brokering strategies work best, in what contexts and why. Learning and behavioural theories will inform this critical explanation. An explanation of how locally tailored evidence-based interventions improve AHPs use of, participation in and leadership of research projects will be summarised and shared with all participating clinicians and within each case study. It is expected that local recommendations will be developed and shared with medical and nursing professionals in and beyond the health service, to facilitate building research capacity in a systematic and effective way. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Mobile Health Technology Interventions for Suicide Prevention: Protocol for a Systematic Review and Meta-Analysis.

PubMed

Melia, Ruth; Francis, Kady; Duggan, Jim; Bogue, John; O'Sullivan, Mary; Chambers, Derek; Young, Karen

2018-01-26

Previous research has reported that two of the major barriers to help-seeking for individuals at risk of suicide are stigma and geographical isolation. Mobile technology offers a potential means of delivering evidence-based interventions with greater specificity to the individual, and at the time that it is needed. Despite documented motivation by at-risk individuals to use mobile technology to track mental health and to support psychological interventions, there is a shortfall of outcomes data on the efficacy of mobile health (mHealth) technology on suicide-specific outcomes. The objective of this study is to develop a protocol for a systematic review and meta-analysis that aims to evaluate the effectiveness of mobile technology-based interventions for suicide prevention. The search includes the Cochrane Central Register of Controlled Trials (CENTRAL: The Cochrane Library), MEDLINE, Embase, PsycINFO, CRESP and relevant sources of gray literature. Studies that have evaluated psychological or nonpsychological interventions delivered via mobile computing and communication technology, and have suicidality as an outcome measure will be included. Two authors will independently extract data and assess the study suitability in accordance with the Cochrane Collaboration Risk of Bias Tool. Studies will be included if they measure at least one suicide outcome variable (ie, suicidal ideation, suicidal intent, nonsuicidal self-injurious behavior, suicidal behavior). Secondary outcomes will be measures of symptoms of depression. Where studies are sufficiently homogenous and reported outcomes are amenable for pooled synthesis, meta-analysis will be performed. A narrative synthesis will be conducted if the data is unsuitable for a meta-analysis. The review is in progress, with findings expected by summer 2018. To date, evaluations of mobile technology-based interventions in suicide prevention have focused on evaluating content as opposed to efficacy. Indeed, previous research has

An integrated strategy of knowledge application for optimal e-health implementation: A multi-method study protocol

PubMed Central

Gagnon, Marie-Pierre; Légaré, France; Fortin, Jean-Paul; Lamothe, Lise; Labrecque, Michel; Duplantie, Julie

2008-01-01

Background E-health is increasingly valued for supporting: 1) access to quality health care services for all citizens; 2) information flow and exchange; 3) integrated health care services and 4) interprofessional collaboration. Nevertheless, several questions remain on the factors allowing an optimal integration of e-health in health care policies, organisations and practices. An evidence-based integrated strategy would maximise the efficacy and efficiency of e-health implementation. However, decisions regarding e-health applications are usually not evidence-based, which can lead to a sub-optimal use of these technologies. This study aims at understanding factors influencing the application of scientific knowledge for an optimal implementation of e-health in the health care system. Methods A three-year multi-method study is being conducted in the Province of Quebec (Canada). Decision-making at each decisional level (political, organisational and clinical) are analysed based on specific approaches. At the political level, critical incidents analysis is being used. This method will identify how decisions regarding the implementation of e-health could be influenced or not by scientific knowledge. Then, interviews with key-decision-makers will look at how knowledge was actually used to support their decisions, and what factors influenced its use. At the organisational level, e-health projects are being analysed as case studies in order to explore the use of scientific knowledge to support decision-making during the implementation of the technology. Interviews with promoters, managers and clinicians will be carried out in order to identify factors influencing the production and application of scientific knowledge. At the clinical level, questionnaires are being distributed to clinicians involved in e-health projects in order to analyse factors influencing knowledge application in their decision-making. Finally, a triangulation of the results will be done using mixed

The design of maternal centered life-style modification program for weight gain management during pregnancy - a study protocol.

PubMed

Farajzadegan, Ziba; Pozveh, Zahra Amini

2013-08-01

Abnormal weight gain during pregnancy increases the adverse health outcomes during the pregnancy, delivery, and the postpartum period. Most of the pregnant women develop weight gain more than the recommended limits; therefore, interventions to manage such disproportionate weight gain are needed. In this paper, the design of the maternal centered life-style intervention study is described, which focuses on controlling weight gaining during pregnancy for all body mass index (BMI) groups. In our randomized field trial, 160 pregnant women with 6-10 weeks of gestational age who visit one of the participating Isfahan four urban public-health centers and 4 private obstetric offices are included. The maternal centered life-style intervention carried out by trained midwives is standardized in a protocol. All the participants are visited at 6-10, 11-15, 16-20, 21-25, 26-30, 31-34, 35-37, 38, 39, and 40 weeks of pregnancy. The women who are randomized in the intervention group receive maternal centered educational package of prenatal care for the pregnant woman and a log book in the first visit. Counselors accompany the pregnant women to maintain or develop a healthy life-style. Data collection will perform monthly measuring body weight, BMI. Because, we don't have structured protocol for weight management during pregnancy especially, in private sectors if the maternal centered life-style intervention proves to be effective, it will be suggested to merge this package to routine care. Therewith by empowering women to manage their weight the public-health burden can be reduced. Beside that private obstetricians also have structured protocol for their client management.

A Standard Mutual Authentication Protocol for Cloud Computing Based Health Care System.

PubMed

Mohit, Prerna; Amin, Ruhul; Karati, Arijit; Biswas, G P; Khan, Muhammad Khurram

2017-04-01

Telecare Medical Information System (TMIS) supports a standard platform to the patient for getting necessary medical treatment from the doctor(s) via Internet communication. Security protection is important for medical records (data) of the patients because of very sensitive information. Besides, patient anonymity is another most important property, which must be protected. Most recently, Chiou et al. suggested an authentication protocol for TMIS by utilizing the concept of cloud environment. They claimed that their protocol is patient anonymous and well security protected. We reviewed their protocol and found that it is completely insecure against patient anonymity. Further, the same protocol is not protected against mobile device stolen attack. In order to improve security level and complexity, we design a light weight authentication protocol for the same environment. Our security analysis ensures resilience of all possible security attacks. The performance of our protocol is relatively standard in comparison with the related previous research.

Health surveillance under adverse ergonomics conditions – validity of a screening method adapted for the occupational health service

PubMed Central

Jonker, Dirk; Gustafsson, Ewa; Rolander, Bo; Arvidsson, Inger; Nordander, Catarina

2015-01-01

A new health surveillance protocol for work-related upper-extremity musculoskeletal disorders has been validated by comparing the results with a reference protocol. The studied protocol, Health Surveillance in Adverse Ergonomics Conditions (HECO), is a new version of the reference protocol modified for application in the Occupational Health Service (OHS). The HECO protocol contains both a screening part and a diagnosing part. Sixty-three employees were examined. The screening in HECO did not miss any diagnosis found when using the reference protocol, but in comparison to the reference protocol considerable time savings could be achieved. Fair to good agreement between the protocols was obtained for one or more diagnoses in neck/shoulders (86%, k = 0.62) and elbow/hands (84%, k = 0.49). Therefore, the results obtained using the HECO protocol can be compared with a reference material collected with the reference protocol, and thus provide information of the magnitude of disorders in an examined work group. Practitioner Summary: The HECO protocol is a relatively simple physical examination protocol for identification of musculoskeletal disorders in the neck and upper extremities. The protocol is a reliable and cost-effective tool for the OHS to use for occupational health surveillance in order to detect workplaces at high risk for developing musculoskeletal disorders. PMID:25761380

Study protocol for two randomized controlled trials examining the effectiveness and safety of current weekend allied health services and a new stakeholder-driven model for acute medical/surgical patients versus no weekend allied health services.

PubMed

Haines, Terry P; O'Brien, Lisa; Mitchell, Deb; Bowles, Kelly-Ann; Haas, Romi; Markham, Donna; Plumb, Samantha; Chiu, Timothy; May, Kerry; Philip, Kathleen; Lescai, David; McDermott, Fiona; Sarkies, Mitchell; Ghaly, Marcelle; Shaw, Leonie; Juj, Genevieve; Skinner, Elizabeth H

2015-04-02

, and patient discharge destination, satisfaction, and functional independence at discharge. This is the world's first application of the recently described non-inferiority (roll-in) stepped wedge trial design, and the largest investigation of the effectiveness of weekend allied health services on acute medical surgical wards to date. Australian New Zealand Clinical Trials Registry. ACTRN12613001231730 (first study) and ACTRN12613001361796 (second study). Was this trial prospectively registered?: Yes. Date registered: 8 November 2013 (first study), 12 December 2013 (second study). Anticipated completion: June 2015. Protocol version: 1. Role of trial sponsor: KP and DL are directly employed by one of the trial sponsors, their roles were: KP assisted with overall development of research design and assisted with overall project management; DL contributed to project management, administration and communications strategy.

Study protocol: cross-national comparative case study of recovery-focused mental health care planning and coordination (COCAPP).

PubMed

Simpson, Alan; Hannigan, Ben; Coffey, Michael; Jones, Aled; Barlow, Sally; Cohen, Rachel; Všetečková, Jitka; Faulkner, Alison; Haddad, Mark

2015-07-03

The collaborative care planning study (COCAPP) is a cross-national comparative study of care planning and coordination in community mental healthcare settings. The context and delivery of mental health care is diverging between the countries of England and Wales whilst retaining points of common interest, hence providing a rich geographical comparison for research. Across England the key vehicle for the provision of recovery-focused, personalised, collaborative mental health care is the care programme approach (CPA). The CPA is a form of case management introduced in England in 1991, then revised in 2008. In Wales the CPA was introduced in 2003 but has now been superseded by The Mental Health (Care Co-ordination and Care and Treatment Planning) (CTP) Regulations (Mental Health Measure), a new statutory framework. In both countries, the CPA/CTP requires providers to: comprehensively assess health/social care needs and risks; develop a written care plan (which may incorporate risk assessments, crisis and contingency plans, advanced directives, relapse prevention plans, etc.) in collaboration with the service user and carer(s); allocate a care coordinator; and regularly review care. The overarching aim of this study is to identify and describe the factors that ensure CPA/CTP care planning and coordination is personalised, recovery-focused and conducted collaboratively. COCAPP will employ a concurrent transformative mixed methods approach with embedded case studies. Phase 1 (Macro-level) will consider the national context through a meta-narrative mapping (MNM) review of national policies and the relevant research literature. Phase 2 (Meso-level and Micro-level) will include in-depth micro-level case studies of everyday 'frontline' practice and experience with detailed qualitative data from interviews and reviews of individual care plans. This will be nested within larger meso-level survey datasets, senior-level interviews and policy reviews in order to provide

Maternal morbidity measurement tool pilot: study protocol.

PubMed

Say, Lale; Barreix, Maria; Chou, Doris; Tunçalp, Özge; Cottler, Sara; McCaw-Binns, Affette; Gichuhi, Gathari Ndirangu; Taulo, Frank; Hindin, Michelle

2016-06-09

While it is estimated that for every maternal death, 20-30 women suffer morbidity, these estimates are not based on standardized methods and measures. Lack of an agreed-upon definition, identification criteria, standardized assessment tools, and indicators has limited valid, routine, and comparable measurements of maternal morbidity. The World Health Organization (WHO) convened the Maternal Morbidity Working Group (MMWG) to develop standardized methods to improve estimates of maternal morbidity. To date, the MMWG has developed a definition and provided input into the development of a set of measurement tools. This protocol outlines the pilot test for measuring maternal morbidity in antenatal and postnatal clinical populations using these new tools. In each setting, the tools will be piloted on approximately 250 women receiving antenatal care (ANC) (at least 28 weeks pregnant) and 250 women receiving postpartum care (PPC) (at least 6 weeks postpartum). The tools will be administered by trained health care workers. Each tool has three modules as follows: 1. personal history - socio-economic information, and risk-factors (such as violence and substance abuse) 2. patient symptoms - WHO Disability Assessment Schedule (WHODAS) 12-item, and mental health questionnaires, General Anxiety Disorder, 7-item (GAD-7) and Personal Health Questionnaire, 9-item (PHQ-9) 3. physical examination - signs, laboratory tests and results. This pilot (planned for Jamaica, Kenya and Malawi) will allow for comparing the types of morbidities women experience between and across settings, and determine the feasibility, acceptability and utility of using a modified, streamlined tool for routine measurement and summary estimates of morbidity to inform resource allocation and service provision. As part of the post-2015 Sustainable Development Goals (SDGs) estimating and measuring maternal morbidity will be essential to ensure appropriate resources are allocated to address its impact and improve

How to write a surgical clinical research protocol: literature review and practical guide.

PubMed

Rosenthal, Rachel; Schäfer, Juliane; Briel, Matthias; Bucher, Heiner C; Oertli, Daniel; Dell-Kuster, Salome

2014-02-01

The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues. On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery. This practical guide outlines key methodologic issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for health care decision making in surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

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

The Korea Nurses' Health Study: A Prospective Cohort Study.

PubMed

Kim, Oksoo; Ahn, Younjhin; Lee, Hea-Young; Jang, Hee Jung; Kim, Sue; Lee, Jung Eun; Jung, Heeja; Cho, Eunyoung; Lim, Joong-Yeon; Kim, Min-Ju; Willett, Walter C; Chavarro, Jorge E; Park, Hyun-Young

2017-08-01

The Korea Nurses' Health Study (KNHS) is a prospective cohort study of female nurses, focusing on the effects of occupational, environmental, and lifestyle risk factors on the health of Korean women. Female registered nurses aged 20-45 years and living in the Republic of Korea were invited to join the study, which began in July 2013. They were asked to complete a web-based baseline survey. The study protocols and questionnaires related to the KNHS are based on the Nurses' Health Study 3 (NHS3) in the United States, although they were modified to reflect the Korean lifestyle. Participants were asked about demographic, lifestyle factors, disease history, occupational exposure, reproductive factors, and dietary habits during their adolescence: Follow-up questionnaires were/will be completed at 6-8 month intervals after the baseline survey. If a participant became pregnant, she answered additional questionnaires containing pregnancy-related information. Among 157,569 eligible female nurses, 20,613 (13.1%) completed the web-based baseline questionnaire. The mean age of the participants was 29.4 ± 5.9 years, and more than half of them were in their 20s. Eighty-eight percent of the participants had worked night shifts as a nurse (mean, 5.3 ± 4.3 nights per month). Approximately 80% of the participants had a body mass index below 23 kg/m 2 . Gastrointestinal diseases were the most prevalent health issues (25.9%). The findings from this prospective cohort study will help to identify the effects of lifestyle-related and occupational factors on reproductive health and development of chronic diseases in Korean women.

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

Taylor, Nicholas F; Brusco, Natasha K; Watts, Jennifer J; Shields, Nora; Peiris, Casey; Sullivan, Natalie; Kennedy, Genevieve; Teo, Cheng Kwong; Farley, Allison; Lockwood, Kylee; Radia-George, Camilla

2010-11-12

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. Australian and New Zealand Clinical Trials Registry ACTRN12609000973213.

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

Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory.

PubMed

Hróbjartsson, Asbjørn; Pildal, Julie; Chan, An-Wen; Haahr, Mette T; Altman, Douglas G; Gøtzsche, Peter C

2009-09-01

To compare the reporting on blinding in protocols and articles describing randomized controlled trials. We studied 73 protocols of trials approved by the scientific/ethical committees for Copenhagen and Frederiksberg, 1994 and 1995, and their corresponding publications. Three out of 73 trials (4%) reported blinding in the protocol that contradicted that in the publication (e.g., "open" vs. "double blind"). The proportion of "double-blind" trials with a clear description of the blinding of participants increased from 11 out of 58 (19%) when based on publications alone to 39 (67%) when adding the information in the protocol. The similar proportions for the blinding of health care providers were 2 (3%) and 22 (38%); and for the blinding of data collectors, they were 8 (14%) and 14 (24%). In 52 of 58 publications (90%), it was unclear whether all patients, health care providers, and data collectors had been blinded. In 4 of the 52 trials (7%), the protocols clarified that all three key trial persons had been blinded. The reporting on blinding in both trial protocols and publications is often inadequate. We suggest developing international guidelines for the reporting of trial protocols and public access to protocols.

Pretravel Health Advice Among Australians Returning From Bali, Indonesia: A Randomized Controlled Trial Protocol.

PubMed

Thomson, Chloe A; Gibbs, Robyn A; Heyworth, Jane S; Giele, Carolien; Firth, Martin J; Effler, Paul V

2016-12-07

The effect of pretravel health advice (PTHA) on travel-related illness rates is poorly understood, and to date there are no published randomized controlled trials evaluating the impact of PTHA outcomes. This study aims to determine the effect of an online PTHA intervention on travel-related illness rates in Western Australians visiting Bali, Indonesia. Western Australian travelers to Bali will be recruited online before departure and will be randomly allocated to an intervention or control group by computer algorithm. The intervention in this study is a short animated video, with accompanying text, containing PTHA relevant to Bali. An online posttravel survey will be administered to all participants within two weeks of their return from Bali. The primary outcome is the difference in self-reported travel-related illness rates between control and intervention groups. Secondary outcomes include the difference in risk prevention behaviors and health risk knowledge between the control and intervention groups. Further secondary outcomes include whether individuals in the control group who sought external PTHA differ from those who did not with respect to risk prevention behaviors, health risk knowledge, and health risk perception, as well as the rate of self-reported travel-related illness. The study began recruitment in September 2016 and will conclude in September 2017. Data analysis will take place in late 2017, with results disseminated via peer-reviewed journals in early 2018. This will be the first randomized controlled trial to examine the effect of a novel PTHA intervention upon travel-related illness. In addition, this study builds upon the limited existing data on the effectiveness of PTHA on travel-related illness. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12615001230549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369567 (Archived by WebCite at http://www.webcitation.org/6m0G7xJg1). ©Chloe Thomson, Robyn A Gibbs

[Protocol of the animal assisted activity program at a university hospital].

PubMed

Silveira, Isa Rodrigues; Santos, Nanci Cristiano; Linhares, Daniela Ribeiro

2011-03-01

Animal-Assisted Activity (AAA) consists in visitation and recreation through contact with animals, aiming at entertainment and improving the interpersonal relationship between patients and staff. Permission for the animals to visit an Institution requires a protocol with rules and safety routines to avoid accidents and zoonoses. The objective of this study is to describe the important points of the protocol to implement the AAA program. The protocol includes: introduction, objectives, inclusion and exclusion criteria for animals, drivers and patients; recommendations to the handlers and the health team, responsibilities of the Nosocomial Infection Control Committee, zoonoses posters, vaccination schedule for dogs and cats, free-informed consent to take part in the program and records with behavioral analysis of the animals. We believe that disclosing the protocol, based on scientific studies, favors the implementation of new programs in institutions considering the lack of national publications.

21 CFR 58.120 - Protocol.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR NONCLINICAL LABORATORY STUDIES Protocol for and Conduct of a Nonclinical Laboratory Study § 58.120 Protocol. (a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following...

Analyzing the effect of routing protocols on media access control protocols in radio networks

DOE Office of Scientific and Technical Information (OSTI.GOV)

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

2002-01-01

We study the effect of routing protocols on the performance of media access control (MAC) protocols in wireless radio networks. Three well known MAC protocols: 802.11, CSMA, and MACA are considered. Similarly three recently proposed routing protocols: AODV, DSR and LAR scheme 1 are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of our experiments was to study how the routing protocols affect the performance of the MAC protocols when the underlying network and traffic parameters are varied. The performance of the protocols was measured w.r.t. five important parameters: (i)more » number of received packets, (ii) average latency of each packet, (iii) throughput (iv) long term fairness and (v) number of control packets at the MAC layer level. Our results show that combinations of routing and MAC protocols yield varying performance under varying network topology and traffic situations. The result has an important implication; no combination of routing protocol and MAC protocol is the best over all situations. Also, the performance analysis of protocols at a given level in the protocol stack needs to be studied not locally in isolation but as a part of the complete protocol stack. A novel aspect of our work is the use of statistical technique, ANOVA (Analysis of Variance) to characterize the effect of routing protocols on MAC protocols. This technique is of independent interest and can be utilized in several other simulation and empirical studies.« less

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

Hirshfield, Sabina; Downing, 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

2016-06-17

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. 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. 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). Participant recruitment began in June 2015 and ended in December 2015. This protocol describes the underlying theoretical framework and

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

Is Home-Based, High-Intensity Interval Training Cycling Feasible and Safe for Patients With Knee Osteoarthritis?: Study Protocol for a Randomized Pilot Study.

PubMed

Keogh, Justin W L; Grigg, Josephine; Vertullo, Christopher J

2017-03-01

Osteoarthritis (OA) is a degenerative joint disease affecting the knee joint of many middle-aged and older adults. As OA symptoms typically involve knee pain and stiffness, individuals with knee OA are often insufficiently physically active, have low levels of physical function, and are at increased risk of other comorbidities and reduced quality of life. While moderate-intensity continuous training (MICT) cycling is often recommended, little is known about the feasibility, safety, and benefits of high-intensity interval training (HIIT) cycling for this population, even though the feasibility, safety, and benefits of HIIT have been demonstrated in other chronic disease groups. The primary objective of this pilot study was to examine the feasibility and safety of home-based HIIT and MICT cycling in middle-aged and older adults with knee OA. A secondary objective was to gain some insight into the relative efficacy of HIIT and MICT for improving health status (pain, stiffness, and disability), muscle function, and body composition in this population. This study protocol is being published separately to allow a detailed description of the research methods, explain the rationale for choosing the methodological details, and to stimulate consideration of the best means to simulate a research protocol that is relevant to a real-life treatment environment. Randomized pilot study protocol. This trial sought to recruit 40 middle-aged and older adults with knee OA. Participants were randomly allocated to either continuous (MICT) or HIIT home-based cycle training programs, with both programs requiring the performance of 4 cycling sessions (approximately 25 minutes per session) each week. Participants were measured at baseline and postintervention (8 weeks). Feasibility and safety were assessed by adherence rate, dropout rate, and number of adverse events. The relative efficacy of the cycling programs was investigated by 2 knee OA health status questionnaires (Western Ontario

Policy to implementation: evidence-based practice in community mental health – study 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

Systematic review of the health and social determinants and outcomes of home cooking: protocol.

PubMed

Mills, Susanna; White, Martin; Robalino, Shannon; Wrieden, Wendy; Brown, Heather; Adams, Jean

2015-03-28

The United Kingdom (UK) and wider world are experiencing an obesity epidemic, with lower socio-economic groups disproportionately affected. Dietary quality is also socio-economically patterned, with an estimated quarter of observed inequalities in UK mortality due to inequalities in diet. Food preparation and eating patterns clearly have an impact on dietary intake and hence health. A growing body of evidence indicates that out of home food consumption and eating ready meals may be associated with negative outcomes. However, to date no systematic reviews have assessed the health and social determinants and outcomes of home cooking. Here, home cooking refers to the combination of actions required for preparing hot or cold foods at home, including combining, mixing and often heating ingredients. A systematic review of peer-reviewed literature on home cooking will be undertaken. Studies will be considered for inclusion if they present qualitative or quantitative data on participants from high/very high human development index countries, including all relevant study designs. No language or date of publication restrictions will be applied. Determinants will be considered as factors that influence behaviour and outcomes as potential advantages and disadvantages of engaging in home cooking. Electronic databases of peer-reviewed journal articles covering health, psychology, social sciences and consumer practices will be searched. Published postgraduate theses will also be considered for inclusion. Additional strategies to identify relevant studies will be used, such as citation searches of included articles, evaluation of references from relevant reviews and included articles and the 'related/similar to' function found in certain databases. Two independent researchers will be involved in literature screening (10% at first screen and 100% at second screen), data extraction and quality appraisal. Studies included in the review will be analysed by thematic synthesis and

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

PubMed

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

2017-01-18

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

The protocol of a population-based prospective cohort study in southwest of Iran to analyze common non-communicable diseases: Shahrekord cohort study.

PubMed

Khaledifar, Arsalan; Hashemzadeh, Morteza; Solati, Kamal; Poustchi, Hosseion; Bollati, Valentina; Ahmadi, Ali; Kheiri, Soleiman; Samani, Keihan Ghatreh; Banitalebi, Mehdi; Sedehi, Morteza; Malekzadeh, Reza

2018-05-25

Prospective cohort studies are considered ideal choices to study multiple outcomes and risk factors for Non-communicable diseases (NCDs). Our aim is to set-up the protocol and analyze risk factors, incidence rates, prevalence, trends, and the models of environmental and genetic determinants of NCDs and their outcomes as well as interaction among such determinants. Shahrekord cohort study (SCS) that is a population-based prospective, study on a cohort consisting of people aged 35-70 years started in November 2015 in Iran. The sample size of the original cohort is at least 10,000 people. Annual follow-ups (200,000 person-year) of the cohort were designed to be conducted up to 2036. Exposures (a detailed demographic, socioeconomic, general health, quality of life, physical activity, anthropometric indexes, stress, health literacy, social capital, nutrition and eating habits, lifestyle, occupational history, living place, blindness, deafness, electrocardiography, lung capacities, blood pressure, sleep, smoking and alcohol, contact to animals, physical examinations and medical history, dental health, used drugs and supplements, glucose and lipid profiles) were measured by relevant standard methods and questionnaires. Incidence of common NCDs (cardiovascular diseases, cancer, gastrointestinal, respiratory, renal, hepatic, accidents, injury and neurological diseases), trend of risk factors, hospitalization, disability, and death were considered the outcomes of the cohort. The definition of disease was determined based on the International Classification of Diseases 10th version (ICD-10). Routine hematologic and biochemical tests were conducted and an all-inclusive biobank (blood, hair, nail, and urine specimens) of the cohort was stored for future studies. All steps of data collection and examinations are directly monitored by the quality control team. The SCS is a unique study conducted in southwest of Iran that is a notable work given the climate conditions and

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

PubMed

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

2016-09-02

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

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

PubMed Central

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

2016-01-01

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

Lung donor treatment protocol in brain dead-donors: A multicenter study.

PubMed

Miñambres, Eduardo; Pérez-Villares, Jose Miguel; Chico-Fernández, Mario; Zabalegui, Arturo; Dueñas-Jurado, Jose María; Misis, Maite; Mosteiro, Fernando; Rodriguez-Caravaca, Gil; Coll, Elisabeth

2015-06-01

The shortage of lung donors for transplantation is the main limitation among patients awaiting this type of surgery. We previously demonstrated that an intensive lung donor-treatment protocol succeeded in increasing the lung procurement rate. We aimed to validate our protocol for centers with or without lung transplant programs. A quasi-experimental study was performed to compare lung donor rate before (historical group, 2010 to 2012) and after (prospective group, 2013) the application of a lung management protocol for donors after brain death (DBDs) in six Spanish hospitals. Lung donor selection criteria remained unchanged in both periods. Outcome measures for lung recipients were early survival and primary graft dysfunction (PGD) rates. A total of 618 DBDs were included: 453 in the control period and 165 in the protocol period. Donor baseline characteristics were similar in both periods. Lung donation rate in the prospective group was 27.3%, more than twice that of the historical group (13%; p < 0.001). The number of lungs retrieved, grafts transplanted, and transplants performed more than doubled over the study period. No differences in early recipients' survival between groups were observed (87.6% vs. 84.5%; p = 0.733) nor in the rate of PGD. Implementing our intensive lung donor-treatment protocol increases lung procurement rates. This allows more lung transplants to be performed without detriment to either early survival or PGD rate. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

A multi-center prospective cohort study to evaluate the effect of differential pricing and health systems strengthening on access to medicines and management of hypertension and diabetes in Ghana: A study protocol.

PubMed

Mobula, Linda Meta; Sarfo, Stephen; Arthur, Lynda; Burnham, Gilbert; Plange-Rhule, Jacob; Ansong, Daniel; Gavor, Edith; Ofori-Adjei, David

2018-02-07

Background: There is evidence to suggest that the prevalence of non-communicable diseases (NCDs), in particular cardiovascular diseases and diabetes, are being recognized as forming a substantial proportion of the burden of disease among populations in Low- and Middle-Income Countries (LMICs).  Access to treatment is likely a key barrier to the control and prevention of NCD outcomes.  Differential pricing, an approach used to price drugs based on the purchasing power of patients in different socioeconomic segments, has been shown to be beneficial and leads to improved access and affordability. Methods: This is a quasi-experimental study, with a pragmatic trial design, to be conducted over the course of three years. A mixed methods design will be used to evaluate the effects of health systems strengthening and differential pricing on the management of diabetes, hypertension and selected cancers in Ghana. A public private partnership was established between all sites that will receive multi-level interventions, including health systems strengthening  and access to medicines interventions. Study populations and sites: Study participants will include individuals with new or recently diagnosed hypertension and diabetes (n=3,300), who present to two major referral hospitals, Komfo Anokye Teaching Hospital and Tamale Teaching Hospital, as well as three district hospitals, namely Kings Medical Centre, Agogo Presbyterian District Hospital, and Atua Government Hospital. Discussion: The objective of this study aims to test approaches intended to improve access to drugs for the treatment of hypertension and diabetes, and improve disease control. Patients with these conditions will benefit from health systems strengthening interventions (education, counseling, improved management of disease), and increased access to innovative medicines via differential pricing. Pilot programs also will facilitate health system strengthening at the participating institutions, which includes

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

PubMed

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

2017-03-01

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

The Impact of mHealth Interventions on Breast Cancer Awareness and Screening: Systematic Review Protocol.

PubMed

Tokosi, Temitope O; Fortuin, Jill; Douglas, Tania S

2017-12-21

include keywords such as "mHealth," "breast cancer," "awareness," and "screening," among other medical subject heading terms. Articles published from January 1, 1964 to December 31, 2016 will be eligible for inclusion. Two authors will independently screen and select studies, extract data, and assess the risk of bias, with discrepancies resolved by dialogue involving a third author. We will assess statistical heterogeneity by examining the types of participants, interventions, study designs, and outcomes in each study, and pool studies judged to be statistically homogeneous. In the assessment of heterogeneity, a sensitivity analysis will be considered to explore statistical heterogeneity. Statistical heterogeneity will be investigated using the Chi-square test of homogeneity on Cochrane's Q statistic and quantified using the I-squared statistic. The search strategy will be refined with the assistance of an information specialist from November 1, 2017 to January 31, 2018. Literature searches will take place from February 2018 to April 2018. Data extraction and capturing in Review Manager (RevMan, Version 5.3) will take place from May 1, 2018 to July 31, 2018. The final stages will include analyses and writing, which is anticipated occur between August 2018 and October 2018. The knowledge derived from this study will inform health care stakeholders, including researchers, policy makers, investors, health professionals, technologists, and engineers, on the impact of mHealth interventions on breast cancer screening and awareness. Prospero registration number CRD42016050202. ©Temitope O Tokosi, Jill Fortuin, Tania S Douglas. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.12.2017.

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

PubMed

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

2017-12-12

maladaptive eating habits. ISRCTN, ID: 70907354 . Registered on 6 February 2017. The ISRCTN registration is in line with the World Health Organization Trial Registration Data Set. The present paper represents the original version of the protocol. Any changes to the protocol will be communicated to ISRCTN.

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and

Clinical Simulation: A Protocol for Evaluation of Mobile Technology.

PubMed

Mather, Carey; Jensen, Sanne; Cummings, Elizabeth

2017-01-01

For mobile technology to be accepted at point of care in healthcare environments there is a need to demonstrate benefits whilst ameliorating the risks and challenges. To provide a standardised approach to evaluation of mobile technology a simulation protocol was developed to provide guidance for its use in healthcare environments. Simulated conditions provide the opportunity to assess intended and unintended consequences and identify potential workarounds when using technology. The protocol can also be used to demonstrate the importance of the development of digital professionalism by end-users prior to students entering the clinical practice setting. The mobile technology protocol was adapted from a health information systems protocol developed and used at the ITX Lab, Denmark for use in other simulation laboratories. Use case scenarios were developed to enable evaluation of mobile technology for mobile learning of nurses, nurse supervisors, students and patients. The scenarios can be used in a range of simulated environments including hospital bedside, outpatient clinic or community settings. A case study exemplar of a nurse and patient is included to demonstrate how the mobile technology protocol can be applied.

Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial

PubMed Central

Beiwinkel, Till; Hey, Stefan; Bock, Olaf; Rössler, Wulf

2017-01-01

Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N = 186 smartphone users will be recruited, with an over-sampling of persons with moderate to high distress. Over a 4-week period, the intervention will be compared to a self-monitoring without intervention group and a passive control group. Telephone interviews will be conducted at baseline, post-intervention (4 weeks), and 12-week follow-up to assess study outcomes. The primary outcome will be improvement of mental health. Secondary outcomes will include well-being, intentions toward help-seeking and help-seeking behavior, user activation, attitudes toward mental-health services, perceived stigmatization, smartphone app quality, user satisfaction, engagement, and adherence with the intervention. Additionally, data from the user’s daily life as collected during self-monitoring will be used to investigate risk and protective factors of mental health in real-world settings. Therefore, this study will allow us to demonstrate the effectiveness of a smartphone application as a widely accessible and low-cost intervention to improve mental health on a population level. It also allows to identify new assessment approaches in the field of psychiatric epidemiology. PMID:28983477

Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial.

PubMed

Beiwinkel, Till; Hey, Stefan; Bock, Olaf; Rössler, Wulf

2017-01-01

Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N  = 186 smartphone users will be recruited, with an over-sampling of persons with moderate to high distress. Over a 4-week period, the intervention will be compared to a self-monitoring without intervention group and a passive control group. Telephone interviews will be conducted at baseline, post-intervention (4 weeks), and 12-week follow-up to assess study outcomes. The primary outcome will be improvement of mental health. Secondary outcomes will include well-being, intentions toward help-seeking and help-seeking behavior, user activation, attitudes toward mental-health services, perceived stigmatization, smartphone app quality, user satisfaction, engagement, and adherence with the intervention. Additionally, data from the user's daily life as collected during self-monitoring will be used to investigate risk and protective factors of mental health in real-world settings. Therefore, this study will allow us to demonstrate the effectiveness of a smartphone application as a widely accessible and low-cost intervention to improve mental health on a population level. It also allows to identify new assessment approaches in the field of psychiatric epidemiology.

eLearning for health system leadership and management capacity building: a protocol for a systematic review.

PubMed

Tudor Car, Lorainne; Atun, Rifat

2017-08-21

Health leadership and management capacity are essential for health system strengthening and for attaining universal health coverage by optimising the existing human, technological and financial resources. However, in health systems, health leadership and management training is not widely available. The use of information technology for education (ie, eLearning) could help address this training gap by enabling flexible, efficient and scalable health leadership and management training. We present a protocol for a systematic review on the effectiveness of eLearning for health leadership and management capacity building in improving health system outcomes. We will follow the Cochrane Collaboration methodology. We will search for experimental studies focused on the use of any type of eLearning modality for health management and leadership capacity building in all types of health workforce cadres. The primary outcomes of interest will be health outcomes, financial risk protection and user satisfaction. In addition, secondary outcomes of interest include the attainment of health system objectives of improved equity, efficiency, effectiveness and responsiveness. We will search relevant databases of published and grey literature as well as clinical trials registries from 1990 onwards without language restrictions. Two review authors will screen references, extract data and perform risk of bias assessment independently. Contingent on the heterogeneity of the collated literature, we will perform either a meta-analysis or a narrative synthesis of the collated data. The systematic review will aim to inform policy makers, investors, health professionals, technologists and educators about the existing evidence, potential gaps in literature and the impact of eLearning for health leadership and management capacity building on health system outcomes. We will disseminate the review findings by publishing it as a peer-reviewed journal manuscript and conference abstracts. PROSPERO CRD

Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

PubMed

García-Gutierrez, Susana; Orive, Miren; Sarasqueta, Cristina; Legarreta, Maria Jose; Gonzalez, Nerea; Redondo, Maximino; Rivero, Amado; Serrano-Aguilar, Pedro; Castells, Xavier; Quintana, Jose Maria; Sala, Maria

2018-01-08

Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for

Occupational radiation exposure and its health effects on interventional medical workers: study protocol for a prospective cohort study

PubMed Central

Ko, Seulki; Chung, Hwan Hoon; Cho, Sung Bum; Jin, Young Woo; Kim, Kwang Pyo; Ha, Mina; Bang, Ye Jin; Ha, Yae Won; Lee, Won Jin

2017-01-01

Introduction Although fluoroscopically guided procedures involve a considerably high dose of radiation, few studies have investigated the effects of radiation on medical workers involved in interventional fluoroscopy procedures. Previous research remains in the early stages and has not reached a level comparable with other occupational studies thus far. Furthermore, the study of radiation workers provides an opportunity to estimate health risks at low doses and dose rates of ionising radiation. Therefore, the objectives of this study are (1) to initiate a prospective cohort study by conducting a baseline survey among medical radiation workers who involve interventional fluoroscopy procedures and (2) to assess the effect of occupational radiation exposure and on the overall health status through an in-depth cross-sectional study. Methods and analysis Intervention medical workers in Korea will be enrolled by using a self-administered questionnaire survey, and the survey data will be linked with radiation dosimetry data, National Health Insurance claims data, cancer registry and mortality data. After merging these data, the radiation organ dose, lifetime attributable risk due to cancer and the risk per unit dose will be estimated. For the cross-sectional study, approximately 100 intervention radiology department workers will be investigated for blood tests, clinical examinations such as ultrasonography (thyroid and carotid artery scan) and lens opacity, the validation of badge dose and biodosimetry. Ethics and dissemination This study was reviewed and approved by the institutional review board of Korea University (KU-IRB-12-12-A-1). All participants will provide written informed consent prior to enrolment. The findings of the study will be disseminated through peer-reviewed scientific journals, conference presentations, and a report will be submitted to the relevant public health authorities in the Korea Centers for Disease Control and Prevention to help with the

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

PubMed

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

2016-07-18

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. 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. Formal ethical approval was not required to undertake this scoping review. Findings will be published in scientific peer-reviewed journals and via conference presentations

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. Copyright 2004 Wiley Periodicals, Inc.

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

PubMed

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

2002-04-01

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

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

PubMed

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

2014-10-25

Few international studies examine public bicycle share programs (PBSP) health impacts. We describe the protocol for the International Bikeshare Impacts on Cycling and Collisions Study (IBICCS). A quasi-experimental non-equivalent groups design was used. Intervention cities (Montreal, Toronto, Boston, New York and Vancouver) were matched to control cities (Chicago, Detroit, and Philadelphia) on total population, population density, cycling rates, and average yearly temperature. The study used three repeated, cross-sectional surveys in intervention and control cities in Fall 2012 (baseline), 2013 (year 1), and 2014 (year 2). A non-probabilistic online panel survey with a sampling frame of individuals residing in and around areas where PBSP are/would be implemented was used. A total of 12,000 respondents will be sampled. In each of the 8 cities 1000 respondents will be sampled with an additional 4000 respondents sampled based on the total population of the city. Survey questions include measures of self-rated health, and self-reported height and weight, knowledge and experience using PBSP, physical activity, bicycle helmet use and history of collisions and injuries while cycling, socio-demographic questions, and home/workplace locations. Respondents could complete questionnaires in English, French, and Spanish. Two weights will be applied to the data: inverse probability of selection and post-stratification on age and sex.A triple difference analysis will be used. This approach includes in the models, time, exposure, and treatment group, and interaction terms between these variables to estimate changes across time, between exposure groups and between cities. There are scientific and practical challenges in evaluating PBSP. Methodological challenges included: appropriate sample recruitment, exchangeability of treatment and control groups, controlling unmeasured confounding, and specifying exposure. Practical challenges arise in the evaluation of environmental

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and

Rationale and Study Protocol for a Multi-component Health Information Technology (HIT) Screening Tool for Depression and Post-traumatic Stress Disorder in the Primary Care Setting

PubMed Central

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

2016-01-01

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

The macular degeneration and aging study: Design and research protocol of a randomized trial for a psychosocial intervention with macular degeneration patients.

PubMed

Sörensen, Silvia; White, Katherine; Mak, Wingyun; Zanibbi, Katherine; Tang, Wan; O'Hearn, Amanda; Hegel, Mark T

2015-05-01

Age-related Macular Degeneration (AMD) is the leading cause of irreversible and predictable blindness among older adults with serious physical and mental health consequences. Visual impairment is associated with negative future outlook and depression and has serious consequences for older adults' quality of life and, by way of depression, on long-term survival. Psychosocial interventions have the potential to alleviate and prevent depression symptoms among older AMD patients. We describe the protocol of the Macular Degeneration and Aging Study, a randomized clinical trial of a psychosocial Preventive Problem-Solving Intervention. The intervention is aimed at enhancing well-being and future planning among older adults with macular degeneration by increasing preparation for future care. Adequate randomization and therapeutic fidelity were achieved. Current retention rates were acceptable, given the vulnerability of the population. Acceptability (adherence and satisfaction) was high. Given the high public health significance and impact on quality of life among older adults with vision loss, this protocol contributes a valid test of a promising intervention for maintaining mental and physical health in this population. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

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

2016-09-01

The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients' mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers' time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression and other mental health disorders in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients' primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder (PTSD) among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

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

PubMed

Barr, Donald A

2007-01-01

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

Protocol for the prospective validation study: 'Screening programme for pre-eclampsia' (SPREE).

PubMed

Tan, M Y; Koutoulas, L; Wright, D; Nicolaides, K H; Poon, L C Y

2017-08-01

Pre-eclampsia (PE), which affects about 2% of pregnancies, is a major cause of maternal and perinatal morbidity and mortality. Early detection of PE can improve pregnancy outcome by providing timely intervention and closer monitoring. The current guideline from the UK National Institute for Health and Care Excellence (NICE) recommends that, at the booking visit, women identified with one major risk factor or more than one moderate risk factor for PE should be advised to take low-dose aspirin daily from 12 weeks until delivery. However, performance of the current method of screening is poor and identifies only about 35% of PE. Extensive studies in the last decade have established that the best performance for early prediction of PE can be achieved by using a novel Bayes' theorem-based method that combines maternal characteristics and medical history together with measurements of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI), serum placental growth factor (PlGF) and pregnancy-associated plasma protein-A (PAPP-A) at 11-13 weeks' gestation. This forms the 'combined test', which could be simplified to the 'mini combined test' when only maternal factors, MAP and PAPP-A are taken into consideration. We present the protocol (version 3.1, 14 November 2016) for the 'Screening programme for pre-eclampsia' (SPREE) study, a prospective multicenter cohort study that will be carried out in seven National Health Service maternity hospitals in England. Eligible pregnant women attending their routine scan at 11-13 weeks' gestation will be invited to participate in this study. Maternal characteristics and history and measurements of MAP, UtA-PI, serum PAPP-A and PlGF will be recorded according to standardized protocols. The patient-specific risk for PE will be calculated and data on pregnancy outcomes collected. We hypothesize that the first-trimester mini combined test and combined test for PE screening, using the Bayes' theorem-based method, are likely to

Peer Review and Publication of Research Protocols and Proposals: A Role for Open Access Journals

PubMed Central

2004-01-01

Peer-review and publication of research protocols offer several advantages to all parties involved. Among these are the following opportunities for authors: external expert opinion on the methods, demonstration to funding agencies of prior expert review of the protocol, proof of priority of ideas and methods, and solicitation of potential collaborators. We think that review and publication of protocols is an important role for Open Access journals. Because of their electronic form, openness for readers, and author-pays business model, they are better suited than traditional journals to ensure the sustainability and quality of protocol reviews and publications. In this editorial, we describe the workflow for investigators in eHealth research, from protocol submission to a funding agency, to protocol review and (optionally) publication at JMIR, to registration of trials at the International eHealth Study Registry (IESR), and to publication of the report. One innovation at JMIR is that protocol peer reviewers will be paid a honorarium, which will be drawn partly from a new submission fee for protocol reviews. Separating the article processing fee into a submission and a publishing fee will allow authors to opt for “peer-review only” (without subsequent publication) at reduced costs, if they wish to await a funding decision or for other reasons decide not to make the protocol public. PMID:15471763

Peer-review and publication of research protocols and proposals: a role for open access journals.

PubMed

Eysenbach, Gunther

2004-09-30

Peer-review and publication of research protocols offer several advantages to all parties involved. Among these are the following opportunities for authors: external expert opinion on the methods, demonstration to funding agencies of prior expert review of the protocol, proof of priority of ideas and methods, and solicitation of potential collaborators. We think that review and publication of protocols is an important role for Open Access journals. Because of their electronic form, openness for readers, and author-pays business model, they are better suited than traditional journals to ensure the sustainability and quality of protocol reviews and publications. In this editorial, we describe the workflow for investigators in eHealth research, from protocol submission to a funding agency, to protocol review and (optionally) publication at JMIR, to registration of trials at the International eHealth Study Registry (IESR), and to publication of the report. One innovation at JMIR is that protocol peer reviewers will be paid a honorarium, which will be drawn partly from a new submission fee for protocol reviews. Separating the article processing fee into a submission and a publishing fee will allow authors to opt for "peer-review only" (without subsequent publication) at reduced costs, if they wish to await a funding decision or for other reasons decide not to make the protocol public.

High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): study protocol for a randomised controlled trial.

PubMed

Ramírez-Vélez, Robinson; Hernandez, Alejandra; Castro, Karem; Tordecilla-Sanders, Alejandra; González-Ruíz, Katherine; Correa-Bautista, Jorge Enrique; Izquierdo, Mikel; García-Hermoso, Antonio

2016-06-24

Although evidence shows the positive health effects of physical activity, most of the adult population in Colombia are sedentary. It is, therefore, important to implement strategies that generate changes in lifestyle behaviours. This protocol describes a study in which we will compare the effects of 12 weeks of high-intensity interval training (HIIT), resistance training (RT) or combined training (HIIT + RT) on the improvement of body composition, endothelial function, blood pressure, blood lipids, and cardiorespiratory fitness in a cohort of sedentary, overweight adults (aged 30-50 years). Sixty sedentary, overweight adults attending primary care in Bogotá, Colombia will be included in a factorial randomised controlled trial. Participants will be randomly assigned to the following intervention groups: (1) non-exercise group: usual care with dietary support, (2) HIIT group: 4 × 4-min intervals at 85-95 % maximum heart rate (HRmax) (with the target zone maintained for at least 2 minutes), interspersed with a 4-min recovery period, at 65 % HRmax, (3) RT group: completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject's weight until an expenditure of 500 kcal at 40-80 % of one-rep max (1RM) has been achieved, and (4) combined group: HIIT + RT. The primary end point for effectiveness is vascular function as measured by flow-mediated vasodilatation 1 week after the end of exercise training. The results of this study will provide new information about the possible effect of the programme in improving the cardiometabolic health of overweight adults, making a more efficient use of an adult's resources over time. ClinicalTrials.gov ID: NCT02715063 . Registered on 8 March 2016.

The relationship and effects of golf on physical and mental health: a scoping review protocol.

PubMed

Murray, A; Daines, L; Archibald, D; Hawkes, R; Grant, L; Mutrie, N

2016-06-01

Golf is a sport played in 206 countries worldwide by over 50 million people. It is possible that participation in golf, which is a form of physical activity, may be associated with effects on longevity, the cardiovascular, metabolic and musculoskeletal systems, as well as on mental health and well-being. We outline our scoping review protocol to examine the relationships and effects of golf on physical and mental health. Best practice methodological frameworks suggested by Arksey and O'Malley, Levac et al and the Joanna Briggs Institute will serve as our guide, providing clarity and rigour. A scoping review provides a framework to (1) map the key concepts and evidence, (2) summarise and disseminate existing research findings to practitioners and policymakers and (3) identify gaps in the existing research. A three-step search strategy will identify reviews as well as original research, published and grey literature. An initial search will identify suitable search terms, followed by a search using keyword and index terms. Two reviewers will independently screen identified studies for final inclusion. We will map key concepts and evidence, and disseminate existing research findings to practitioners and policymakers through peer-reviewed and non-peer reviewed publications, conferences and in-person communications. We will identify priorities for further study. This method may prove useful to examine the relationships and effects of other sports on health. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol.

PubMed

Gimbel, Ronald; Shi, Lu; Williams, Joel E; Dye, Cheryl J; Chen, Liwei; Crawford, Paul; Shry, Eric A; Griffin, Sarah F; Jones, Karyn O; Sherrill, Windsor W; Truong, Khoa; Little, Jeanette R; Edwards, Karen W; Hing, Marie; Moss, Jennie B

2017-03-06

Diabetes Self-care Activities Measure scores, clinical measures, comorbid conditions, health services resource consumption, and technology system usage statistics. We have completed phase 1 data collection. Formal analysis of phase 1 data has not been completed. We have obtained institutional review board approval and began phase 1 research in late fall 2016. The study hypotheses suggest that patients can, and will, improve their activation in chronic care management. Improved activation should translate into improved diabetes self-care. Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting. ClinicalTrials.gov NCT02949037. https://clinicaltrials.gov/ct2/show/NCT02949037. (Archived by WebCite at http://www.webcitation.org/6oRyDzqei). ©Ronald Gimbel, Lu Shi, Joel E Williams, Cheryl J Dye, Liwei Chen, Paul Crawford, Eric A Shry, Sarah F Griffin, Karyn O Jones, Windsor W Sherrill, Khoa Truong, Jeanette R Little, Karen W Edwards, Marie Hing, Jennie B Moss. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 06.03.2017.

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

PubMed

Gunn, Caroline A; Weber, Janet L; Kruger, Marlena C

2013-01-10

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. 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. 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. This study will provide information on midlife women's bone health and how a dietary intervention

Performing piety in sexual health research: gender, health and evangelical Christianities in a Mexican human papillomavirus (HPV) study.

PubMed

Wentzell, Emily

2017-12-01

Recent research suggests that health surveillance experiences like clinical trial participation might have unanticipated social consequences. I investigate how evangelical Christians participating in longitudinal, observational sexual health research incorporate that long-term medical surveillance into their religious practice. This exploratory research focuses on Mexican Cristianos' participation in the Cuernavaca arm of the multinational 'Human Papillomavirus in Men' ('HIM') study, which tested men for the common and usually asymptomatic sexually transmitted infection human papillomavirus (HPV) over time. I draw on interviews with heterosexual male research participants and their female partners throughout their medical research involvement, and data from church-based participant observation, to understand how couples framed the HIM study as an arena for performing piety. I argue that evangelical understandings of piety as moral practice encouraged participants to view long-term sexual health surveillance as assistance for living out the health, gender, and marital behaviors promoted by their congregations. This finding suggests that health research designers and ethics committees should consider the health and social outcomes of research participants' agentive incorporation of religious observance into study protocols.

Healthcare professionals' behavior, skills, knowledge and attitudes on evidence-based health practice: a protocol of cross-sectional study.

PubMed

Mariano, Arielly Souza; Souza, Nathan Mendes; Cavaco, Afonso; Lopes, Luciane Cruz

2018-06-04

In Brazil, as in most countries nowadays, there is a pursuit for healthcare quality improvement and sustainability in public and private systems. Healthcare professionals' perceptions, knowledge and attitudes determine evidence-based practice (EBP), which remain uncertain among Brazilian practitioners. A standardised national instrument whose wide use will identify gaps and flaws in establishing an EBP could contribute to an effective resources allocation from health professionals willing to use an EBP. To present a study protocol on the development and validation of an instrument to measure Brazilian healthcare professionals' behaviour, skills, self-efficacy, knowledge and attitudes towards EBP. This is a validation study with Brazilian healthcare professionals to develop a valid and reliable questionnaire, including selection of domains and formulation of questions. Construct and content validity will be assess by a panel of experts, with data collection and analysis following a Delphi-like methodology. Further, a pilot survey will be accomplished with a representative sample of different healthcare professionals from all main Brazilian regions. An exploratory factor analysis and a confirmatory factor analysis will be conducted afterwards. The ratio of χ 2 and df (χ 2 /df), comparative fit index, goodness of fit index and root mean square error of approximation will be used for assessing the model fit. In addition, the reliability of the instrument will be estimated by test-retest reproducibility and Cronbach's alpha coefficient (α). This study has received ethical approval from the Pharmaceutical Sciences Faculty of the São Paulo State University (1.425.808). The use among a wide national sample is expected to promote an extensive view of evidence-based decision-making, identifying the knowledge gaps in this area. Study findings will be circulated to healthcare professionals and scientists in the field through the publication in peer-reviewed journals and

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

PubMed

Annesi-Maesano, Isabella; Norback, Dan; Zielinski, Jan; Bernard, Alfred; Gratziou, Cristina; Sigsgaard, Torben; Sestini, Piersante; Viegi, Giovanni

2013-11-21

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. We describe here the rationale and the methods of the GERIE Study. 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. 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. 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 because of reduced mobility.

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

Occupational radiation exposure and its health effects on interventional medical workers: study protocol for a prospective cohort study.

PubMed

Ko, Seulki; Chung, Hwan Hoon; Cho, Sung Bum; Jin, Young Woo; Kim, Kwang Pyo; Ha, Mina; Bang, Ye Jin; Ha, Yae Won; Lee, Won Jin

2017-12-15

Although fluoroscopically guided procedures involve a considerably high dose of radiation, few studies have investigated the effects of radiation on medical workers involved in interventional fluoroscopy procedures. Previous research remains in the early stages and has not reached a level comparable with other occupational studies thus far. Furthermore, the study of radiation workers provides an opportunity to estimate health risks at low doses and dose rates of ionising radiation. Therefore, the objectives of this study are (1) to initiate a prospective cohort study by conducting a baseline survey among medical radiation workers who involve interventional fluoroscopy procedures and (2) to assess the effect of occupational radiation exposure and on the overall health status through an in-depth cross-sectional study. Intervention medical workers in Korea will be enrolled by using a self-administered questionnaire survey, and the survey data will be linked with radiation dosimetry data, National Health Insurance claims data, cancer registry and mortality data. After merging these data, the radiation organ dose, lifetime attributable risk due to cancer and the risk per unit dose will be estimated. For the cross-sectional study, approximately 100 intervention radiology department workers will be investigated for blood tests, clinical examinations such as ultrasonography (thyroid and carotid artery scan) and lens opacity, the validation of badge dose and biodosimetry. This study was reviewed and approved by the institutional review board of Korea University (KU-IRB-12-12-A-1). All participants will provide written informed consent prior to enrolment. The findings of the study will be disseminated through peer-reviewed scientific journals, conference presentations, and a report will be submitted to the relevant public health authorities in the Korea Centers for Disease Control and Prevention to help with the development of appropriate research and management policies. �

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

Patient-Centred Innovations for Persons with Multimorbidity: funded evaluation protocol.

PubMed

Stewart, Moira; Fortin, Martin

2017-05-09

The high prevalence of multimorbidity necessitates rethinking of the health care system. The overarching goal of the Patient-Centred Innovations for Persons with Multimorbidity program is to build on existing structures and find and evaluate patient-centred innovations relevant to multimorbidity. We describe the protocol for a proposed multijurisdictional (Quebec and Ontario) concurrent triangulation mixed-methods study. In both provinces, a qualitative descriptive study will be used to explore innovations in patient-centred multimorbidity care. Two randomized controlled trials, 1 in either province, will evaluate the innovations in a wait-list-controlled design using patient-reported outcomes. An additional control group, matched on age, sex, enrolment/index date (± 3 mo) and propensity score, will be created with the use of health administrative data. Patients will be 18-80 years of age and will have 3 or more chronic conditions. The innovations will have elements of relevance to multimorbidity care, patient-centred partnerships and integration of care. The primary outcome measures will be 2 patient-reported outcomes: patient education and self-efficacy. Secondary outcomes will include patient-reported health status, quality of life, psychological distress and health behaviours, and costs of care. This protocol describes a mixed-method study in 2 jurisdictions. The studies will answer the questions of what innovations work and how they work for patients, health care professionals and policy-makers. Trial registration: ClinicalTrials.gov, no NCT02789800 (Quebec Trial), NCT02742597 (Ontario Trial). Copyright 2017, Joule Inc. or its licensors.

Flight related tuberculosis contact investigations in the United States: comparative risk and economic analysis of alternate protocols.

PubMed

Marienau, Karen J; Cramer, Elaine H; Coleman, Margaret S; Marano, Nina; Cetron, Martin S

2014-01-01

In-flight transmission risk of Mycobacterium tuberculosis is not well defined, although studies suggest it is low. The impact of flight-related tuberculosis (TB) contact investigations (TBCIs) on TB prevention and control is not well established, and they compete for resources with activities with established benefits. We sought to determine the risks and cost-benefits of using more restrictive criteria in comparison to the Centers for Disease Control and Prevention (CDC) 2008 protocol for TBCIs. The risk-benefits of a modified CDC protocol were analyzed in comparison to the 2008 CDC protocol using data from flight-related TBCIs conducted in the United States from 2007 through 2009. We predicted the numbers and characteristics of case-travelers that would be identified using each protocol's criteria, and results of the associated passenger-contacts' TB screening tests. The economic analysis compared the costs of TBCIs to avoided costs of TB treatment and mortality using a Return on Investment model. The estimated in-flight transmission risk using a modified CDC protocol was 1.4%-19% versus 1.1%-24% for the 2008 protocol. Numbers of TBCIs and immediate costs to health departments were reduced by half. Long-term cost-benefits were comparable. CDC's modified protocol appears to be a feasible alternative that will conserve public health resources without jeopardizing the public's health. Published by Elsevier Ltd.

[Study protocol of a prevention of recurrent suicidal behaviour program based on case management (PSyMAC)].

PubMed

Sáiz, Pilar A; Rodríguez-Revuelta, Julia; González-Blanco, Leticia; Burón, Patricia; Al-Halabí, Susana; Garrido, Marlen; García-Alvarez, Leticia; García-Portilla, Paz; Bobes, Julio

2014-01-01

Prevention of suicidal behaviour is a public health priority in the European Union. A previous suicide attempt is the best risk predictor for future attempts, as well as completed suicides. The primary aim of this article is to describe a controlled study protocol designed for prevention of recurrent suicidal behaviour that proposes case management, and includes a psychoeducation program, as compared with the standard intervention (PSyMAC). Patients admitted from January 2011 to June 2013 to the emergency room of the Hospital Universitario Central de Asturias were evaluated using a protocol including sociodemographic, psychiatric, and psychosocial assessment. Patients were randomly assigned to either a group receiving continuous case management including participation in a psychoeducation program (experimental group), or a control group receiving standard care. The primary objective is to examine whether or not the period of time until recurrent suicidal behaviour in the experimental group is significantly different from that of the control group. PSyMAC proposes low cost and easily adaptable interventions to the usual clinical setting that can help to compensate the shortcoming of specific action protocols and suicidal behaviour prevention programs in our country. The evaluation of PSyMAC results will determine their real effectivity as a case-magament program to reduce suicidal risk. Copyright © 2013 SEP y SEPB. Published by Elsevier España. All rights reserved.

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mendell, Mark; Eliseeva, Ekaterina; Spears, Michael

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 (21-34percentmore » 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.« less

Protocol-based care: the standardisation of decision-making?

PubMed

Rycroft-Malone, Jo; Fontenla, Marina; Seers, Kate; Bick, Debra

2009-05-01

To explore how protocol-based care affects clinical decision-making. In the context of evidence-based practice, protocol-based care is a mechanism for facilitating the standardisation of care and streamlining decision-making through rationalising the information with which to make judgements and ultimately decisions. However, whether protocol-based care does, in the reality of practice, standardise decision-making is unknown. This paper reports on a study that explored the impact of protocol-based care on nurses' decision-making. Theoretically informed by realistic evaluation and the promoting action on research implementation in health services framework, a case study design using ethnographic methods was used. Two sites were purposively sampled; a diabetic and endocrine unit and a cardiac medical unit. Within each site, data collection included observation, postobservation semi-structured interviews with staff and patients, field notes, feedback sessions and document review. Data were inductively and thematically analysed. Decisions made by nurses in both sites were varied according to many different and interacting factors. While several standardised care approaches were available for use, in reality, a variety of information sources informed decision-making. The primary approach to knowledge exchange and acquisition was person-to-person; decision-making was a social activity. Rarely were standardised care approaches obviously referred to; nurses described following a mental flowchart, not necessarily linked to a particular guideline or protocol. When standardised care approaches were used, it was reported that they were used flexibly and particularised. While the logic of protocol-based care is algorithmic, in the reality of clinical practice, other sources of information supported nurses' decision-making process. This has significant implications for the political goal of standardisation. The successful implementation and judicious use of tools such as

Protocol to monitor trade agreement food-related aspects: the Fiji case study.

PubMed

Ravuvu, Amerita; Friel, Sharon; Thow, Anne Marie; Snowdon, Wendy; Wate, Jillian

2017-04-26

Despite the growing rates of obesity and diet-related non-communicable diseases, globally, public health attention has only relatively recently turned to the links between trade agreements and the nutritional risks associated with it. Specific trade agreements appear to have played an influential role in the volume and types of foods entering different countries, yet there is currently no systematic and objective monitoring of trade agreements for their impacts on food environments. Recently, INFORMAS was set up to monitor and benchmark food environments, government policies and private sector actions within countries and globally. One of its projects/modules focuses on trade policy and in particular the food-related aspects of trade agreements. This paper describes the INFORMAS trade protocol, an approach to collecting food-related information about four domains of trade: trade in goods; trade in services and foreign direct investment; domestic supports, and policy space. Specifically, the protocol is tested in Fiji. The development and testing of this protocol in Fiji represents the first effort to set out a framework and process for objectively monitoring trade agreements and their impacts on national food supply and the wider food environment. It has shown that entry into WTO trade agreements contributed to the nutrition transition in Fiji through the increased availability of imported foods with varying nutritional quality. We observed an increase in imports of both healthy and less healthy foods. The application of the monitoring protocol also highlights challenges for data collection associated with each trade domain that should be considered for future data collection and analysis in other low and middle income countries. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Measuring the impact of a health information exchange intervention on provider-based notifiable disease reporting using mixed methods: a study protocol.

PubMed

Dixon, Brian E; Grannis, Shaun J; Revere, Debra

2013-10-30

Health information exchange (HIE) is the electronic sharing of data and information between clinical care and public health entities. Previous research has shown that using HIE to electronically report laboratory results to public health can improve surveillance practice, yet there has been little utilization of HIE for improving provider-based disease reporting. This article describes a study protocol that uses mixed methods to evaluate an intervention to electronically pre-populate provider-based notifiable disease case reporting forms with clinical, laboratory and patient data available through an operational HIE. The evaluation seeks to: (1) identify barriers and facilitators to implementation, adoption and utilization of the intervention; (2) measure impacts on workflow, provider awareness, and end-user satisfaction; and (3) describe the contextual factors that impact the effectiveness of the intervention within heterogeneous clinical settings and the HIE. The intervention will be implemented over a staggered schedule in one of the largest and oldest HIE infrastructures in the U.S., the Indiana Network for Patient Care. Evaluation will be conducted utilizing a concurrent design mixed methods framework in which qualitative methods are embedded within the quantitative methods. Quantitative data will include reporting rates, timeliness and burden and report completeness and accuracy, analyzed using interrupted time-series and other pre-post comparisons. Qualitative data regarding pre-post provider perceptions of report completeness, accuracy, and timeliness, reporting burden, data quality, benefits, utility, adoption, utilization and impact on reporting workflow will be collected using semi-structured interviews and open-ended survey items. Data will be triangulated to find convergence or agreement by cross-validating results to produce a contextualized portrayal of the facilitators and barriers to implementation and use of the intervention. By applying mixed

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

PubMed

Fung, Colman Siu Cheung; Yu, Esther Yee Tak; Guo, Vivian Yawei; Wong, Carlos King Ho; 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

2016-02-03

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. 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. 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 Foundation (Hong Kong) Limited. Published by the BMJ Publishing Group

The impact of mHealth interventions on health systems: a systematic review protocol.

PubMed

Fortuin, Jill; Salie, Faatiema; Abdullahi, Leila H; Douglas, Tania S

2016-11-25

Mobile health (mHealth) has been described as a health enabling tool that impacts positively on the health system in terms of improved access, quality and cost of health care. The proposed systematic review will examine the impact of mHealth on health systems by assessing access, quality and cost of health care as indicators. The systematic review will include literature from various sources including published and unpublished/grey literature. The databases to be searched include: PubMed, Cochrane Library, Google Scholar, NHS Health Technology Assessment Database and Web of Science. The reference lists of studies will be screened and conference proceedings searched for additional eligible reports. Literature to be included will have mHealth as the primary intervention. Two authors will independently screen the search output, select studies and extract data; discrepancies will be resolved by consensus and discussion with the assistance of the third author. The systematic review will inform policy makers, investors, health professionals, technologists and engineers about the impact of mHealth in strengthening the health system. In particular, it will focus on three metrics to determine whether mHealth strengthens the health system, namely quality of, access to and cost of health care services. Systematic review registration: PROSPERO CRD42015026070.

Advanced dementia pain management protocols.

PubMed

Montoro-Lorite, Mercedes; Canalias-Reverter, Montserrat

Pain management in advanced dementia is complex because of neurological deficits present in these patients, and nurses are directly responsible for providing interventions for the evaluation, management and relief of pain for people suffering from this health problem. In order to facilitate and help decision-makers, pain experts recommend the use of standardized protocols to guide pain management, but in Spain, comprehensive pain management protocols have not yet been developed for advanced dementia. This article reflects the need for an integrated management of pain in advanced dementia. From the review and analysis of the most current and relevant studies in the literature, we performed an approximation of the scales for the determination of pain in these patients, with the observational scale PAINAD being the most recommended for the hospital setting. In addition, we provide an overview for comprehensive management of pain in advanced dementia through the conceptual framework «a hierarchy of pain assessment techniques by McCaffery and Pasero» for the development and implementation of standardized protocols, including a four-phase cyclical process (evaluation, planning/performance, revaluation and recording), which can facilitate the correct management of pain in these patients. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Comparison of registered and published intervention fidelity assessment in cluster randomised trials of public health interventions in low- and middle-income countries: systematic review protocol.

PubMed

Pérez, Myriam Cielo; Minoyan, Nanor; Ridde, Valéry; Sylvestre, Marie-Pierre; Johri, Mira

2016-10-19