JMIR Publications

JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results


Journal Description


JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

  • JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor: 4.7)
  • JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions
  • JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central
  • Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort 
  • JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal
  • JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols
  • JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced
  • JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods
  • Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine
  • Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)

Recent Articles:

  • BP Home. Image created by authors who own the copyright.

    Digital Interventions to Promote Self-Management in Adults With Hypertension: Protocol for Systematic Review and Meta-Analysis


    Background: Digital interventions, defined as any intervention accessed and taking input from patients in the form of a computer/Web-based program or mobile phoned-based app, can potentially help empower patients to self-manage long-term conditions such as hypertension. Importantly, digital interventions have the potential to provide patients with personalized information and support for active involvement in treatment as well as cost saving. Objective: The purpose of this systematic review is to synthesize the evidence for using digital interventions to support patient self-management of hypertension, and determine their impact on control and reduction of blood pressure, other clinical outcomes, quality of life, medication adherence, health service utilization, and economic benefits. Methods: A systematic search of bibliographic databases including Medline, Embase, CINAHL, and PsycINFO will be undertaken. Abstracts and citations will be independently screened by 2 researchers against predetermined inclusion criteria. Any disagreements will be resolved by discussion and further consideration of the inclusion criteria. Only randomized controlled trials which have been published in peer peer-reviewed journals with a diagnosis of hypertension will be considered. Inclusion criteria will be (1) adults (age ≥ 18 years) with hypertension (as defined by the primary authors); (2) an interactive digital intervention compared with usual care; and (3) outcomes of objectively measured change in blood pressure. Data extraction from identified articles will be undertaken by 2 independent reviewers using a uniform template. The main outcomes are systolic blood pressure (SBP) and diastolic blood pressure (DBP), and quality of life indicators. Secondary outcomes include cost- effectiveness, medication adherence, emotional well-being, and physical activity. Risk of bias of included studies will be assessed using the Cochrane tool. Results: Our research is currently ongoing. Data will be summarized narratively, and if possible, meta-analyses will be performed to assess the impact of the interventions on outcomes. Conclusions: By summarizing and synthesizing available data, this review will help inform policy on the use of digital interventions for self-management of hypertension and will clarify areas for further research. Trial Registration: Prospero 2014: CRD42014010268; ID=CRD42014010268 (Archived by WebCite at

  • Alcohol and cost (Image from:

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


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

  • This image is from the public domain

    Nutritional Risk in Major Abdominal Surgery: Protocol of a Prospective Observational Trial to Evaluate the Prognostic Value of Different Nutritional Scores...


    Background: The influence of patients’ preoperative nutritional status on their clinical outcome has already been proven. Therefore, patients with malnutrition are in need of additional therapeutic efforts. However, for pancreatic surgery, evidence suggesting the adequacy of existing nutritional assessment scores to estimate malnutrition associated with postoperative outcome is limited. Objective: The aim of the observational trial “Nutritional Risk in Major Abdominal Surgery (NURIMAS) Pancreas” is to prospectively assess and analyze different nutritional assessment scores for their prognostic value on postoperative complications in patients undergoing pancreatic surgery. Methods: All patients scheduled to receive elective pancreatic surgery at the University Hospital of Heidelberg will be screened for eligibility. Preoperatively, 12 nutritional assessment scores will be collected and patients will be assigned either at risk or not at risk for malnutrition. The postoperative course will be followed prospectively and complications according to the Clavien-Dindo classification will be recorded. The prognostic value for complications will be evaluated for every score in a univariable and multivariable analysis corrected for known risk factors in pancreatic surgery. Results: Final data analysis is expected to be available during Spring 2016. Conclusions: The NURIMAS Pancreas trial is a monocentric, prospective, observational trial aiming to find the most predictive clinical nutritional assessment score for postoperative complications. Using the results of this protocol as a knowledge base, it is possible to conduct nutritional risk-guided intervention trials to prevent postoperative complications in the pancreatic surgical population. Trial Registration: DRKS00006340; (Archived by WebCite at

  • e-Bug website homepage.

'e-Bug is licensed under a Creative Commons Attribution-Non-Commercial-Share Alike 2.0 UK: England & Wales License'.

    Monitoring Web Site Usage of e-Bug: A Hygiene and Antibiotic Awareness Resource for Children


    Background: e-Bug is an educational resource which teaches children and young people about microbes, hygiene, infection, and prudent antibiotic use. The e-Bug resources are available in over 22 different languages and they are used widely across the globe. The resources can be accessed from the e-Bug website. Objective: The objective of this study was to analyze the usage of the e-Bug website in order to understand how users access the website, where and when they access the site, and to review variation in use across the different areas of the site. Methods: The usage statistics for the e-Bug website were monitored by Google Analytics between September 2010 and August 2013. Results: The statistics show the website had over 324,000 visits during the three years, from just under 250,000 visitors, with the number of visitors increasing year after year. Visitors accessed the website from 211 different countries, with more than 267,000 documents downloaded. The majority of visitors were from the United Kingdom and visited the English website, although countries such as France and Portugal were also frequent visitors. Conclusions: These website statistics confirm that e-Bug is frequently used across Europe and highlight that e-Bug use has expanded across the world. The findings from this report will be used to inform future modifications or updates to the materials, as well as the development of new educational resources.

  • Homepage of the Brain Aging Monitor.

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


    Background: Internet-delivered intervention programs are an effective way of changing health behavior in an aging population. The same population has an increasing number of people with cognitive decline or cognitive impairments. Modifiable lifestyle risk factors such as physical activity, nutrition, smoking, alcohol consumption, sleep, and stress all influence the probability of developing neurodegenerative diseases such as Alzheimer’s disease. Objective: This study aims to answer two questions: (1) Is the use of a self-motivated, complex eHealth intervention effective in changing multiple health behaviors related to cognitive aging in Dutch adults in the work force, especially those aged 40 and over? and (2) Does this health behavior change result in healthier cognitive aging patterns and contribute to preventing or delaying future onset of neurodegenerative syndromes? Methods: The Brain Aging Monitor study uses a quasi-experimental 2-year pre-posttest design. The Brain Aging Monitor is an online, self-motivated lifestyle intervention program. Recruitment is done both in medium to large organizations and in the Dutch general population over the age of 40. The main outcome measure is the relationship between lifestyle change and cognitive aging. The program uses different strategies and modalities such as Web content, email, online newsletters, and online games to aid its users in behavior change. To build self-regulatory skills, the Brain Aging Monitor offers its users goal-setting activities, skill-building activities, and self-monitoring. Results: Study results are expected to be published in early 2016. Conclusions: This study will add to the body of evidence on the effectiveness of eHealth intervention programs with the combined use of state-of-the-art applied games and established behavior change techniques. This will lead to new insights on how to use behavior change techniques and theory in multidimensional lifestyle eHealth research, and how these techniques and theories apply when they are used in a setting where no professional back-end is available. Trial Registration: Nederlands Trial Register: NTR4144; (Archived by WebCite at

  • Keyboard with stethoscope (
CC BY-SA 2.0.

    Changes in Physical Activity and Psychological Variables Following a Web-Based Motivational Interviewing Intervention: Pilot Study


    Background: Web-based interventions for enhancing physical activity participation are in demand for application in health care settings. Recent research suggests Web-based interventions that are based on motivational interviewing are effective to increase physical activity. It is unclear whether motivational interviewing can influence targeted psychological variables such as perceived readiness, willingness, and ability to participate in physical activity. Objective: The aims of this study were to determine whether there were changes in physical activity and psychological variables associated with readiness, willingness, and perceived ability to participate in physical activity following completion of a novel Web-based intervention. The goal of the motivational interviewing–based intervention was to increase physical activity. Methods: Twenty-three underactive or inactive urban dwelling adults were recruited at a medical office for participation in a 4-session Web-based intervention lasting approximately 15 minutes per week. Sessions were based on principles of motivational interviewing. Assessment of physical activity was conducted using pedometers immediately prior to intervention participation (pre) and immediately post intervention (post1). Self-report assessments of physical activity and psychological variables were conducted using online surveys at pre, post1, and again at one month following intervention participation (post2). Results: Comparisons of pre and post1 pedometer recordings revealed significant increases in steps per day (t22=2.09, P=.049). There were also significant changes in total physical activity energy expenditure per week (χ22=8.4, P=.02) and in moderate intensity physical activity energy expenditure per week (χ22=13.9, P<.001) over time following participation in the Web-based intervention. Significant changes in psychological variables following participation in the Web-based intervention included: (1) change in stage classification over time (χ22=21.5, P<.001), where the percentage of participants classified in the action or maintenance stages of change in physical activity increased over time (pre=25% [6/24], post1=71% [17/24], post2=68% [15/22]); (2) decreases in self-reported decisional balance cons (F2,42=12.76, P<.001); (3) increases in self-reported decisional balance pros (F2,42=16.19, P<.001); (4) increases in physical activity enjoyment (F2,20=3.85, P=.04); and (5) increases in self-efficacy (F2,42=3.30, P=.047). Conclusions: The Web-based intervention piloted in this study shows preliminary promise as a tool to promote physical activity in health care settings. Additional research is needed to test the effectiveness of motivational interviewing compared to a control condition and to refine content by considering mediation by psychological variables in a larger sample.

  • (cc) Soong et al, CC-BY-SA 2.0, please cite as

    A “Community Fit” Community-Based Participatory Research Program for Family Health, Happiness, and Harmony: Design and Implementation


    Background: A principal factor in maintaining positive family functioning and well-being, family communication time is decreasing in modern societies such as Hong Kong, where long working hours and indulgent use of information technology are typical. Objective: The objective of this paper is to describe an innovative study protocol, “Happy Family Kitchen,” under the project, “FAMILY: A Jockey Club Initiative for a Harmonious Society,” aimed at improving family health, happiness, and harmony (3Hs) through enhancement of family communication. Methods: This study employed the community-based participatory research (CBPR) approach, and adopted 5 principles of positive psychology and the traditional Chinese concepts of cooking and dining, as a means to connect family members to promote family health, happiness, and harmony (3Hs). Results: In-depth collaboration took place between an academic institution and a large nongovernmental community organization association (NGO association) with 400 social service agency members. Both groups were deeply involved in the project design, implementation, and evaluation of 23 community-based interventions. From 612 families with 1419 individuals’ findings, significant increases in mean communication time per week (from 153.44 to 170.31 minutes, P=.002) at 6 weeks after the intervention and mean communication scores (from 67.18 to 69.56 out of 100, P<.001) at 12 weeks after the intervention were shown. Significant enhancements were also found for mean happiness scores 12 weeks after the intervention (from 7.80 to 7.82 out of 10, P<.001), and mean health scores (from 7.70 to 7.73 out of 10, P<.001) and mean harmony scores (from 7.70 to 8.07 out of 10, P<.001) 6 weeks after the intervention. Conclusions: This was the first CBPR study in a Hong Kong Chinese community. The results should be useful in informing collaborative intervention programs and engaging public health researchers and community social service providers, major stakeholders, and community participants in the promotion of family well-being. Furthermore, this study has generated an effective practice model for the improvement of family communication and well-being. Challenges in maintaining research rigor during data collection and program implementation were observed, and should be considered during future program planning.

  • BMT Roadmap.

    A Novel Health Information Technology Communication System to Increase Caregiver Activation in the Context of Hospital-Based Pediatric Hematopoietic Cell...


    Background: Pediatric hematopoietic cell transplantation (HCT), commonly referred to as blood and marrow transplantation (BMT), is an intense treatment modality that requires the involvement of engaged caregivers during the patient’s (child’s) prolonged hospitalization. The ubiquity of electronic health records (EHRs) and a trend toward patient-centered care could allow a novel health information technology (IT) system to increase parental engagement. The paucity of research on acute care, hospital-based (inpatient) health IT applications for patients or caregivers provides an opportunity for testing the feasibility of such applications. The pediatric BMT population represents an ideal patient group to conduct an evaluation due to the lengthy inpatient stays and a heightened need for patient activation. Objective: The primary objective of this study is to assess the feasibility of implementing the BMT Roadmap in caregivers as an intervention during their child’s inpatient hospitalization. The BMT Roadmap is an inpatient portal prototype optimized for tablet with a user-centered design. It integrates patient-specific laboratory and medication data from the EHR in real-time and provides support in terms of discharge goals, home care education, and other components. Feasibility will be proven if (1) the BMT Roadmap functions and can be managed by the study team without unexpected effort, (2) the system is accessed by users at a defined minimum threshold, and (3) the qualitative and quantitative research conducted provides quality data that address the perceived usefulness of the BMT Roadmap and could inform a study in a larger sample size. Methods: This will be a single-arm, nonrandomized feasibility study. We aim to enroll 10 adult caregivers (age ≥ 18 years) of pediatric patients (aged 0-25 years) undergoing autologous (self-donor) or allogeneic (alternative donor) BMT. Assenting minors (aged 10-18) will also be invited to participate. Recruitment of study participants will take place in the outpatient pediatric BMT clinic. After signing an informed consent, the research study team will provide participants with the BMT Roadmap, available on an Apple iPad, which will used throughout the inpatient hospitalization. To measure the study outcomes, approximately 6-8 semistructured qualitative interviews will be conducted periodically from pre-BMT to 100 days post-BMT and an additional 15-20 semistructured interviews will be conducted among BMT health care providers to assess perceived usefulness and usability of the system, as well as any associated workflow impacts. Quantitative survey instruments will only be administered to adult participants (age ≥ 18 years). Results: Recruitment will begin in September 2015, and preliminary findings are expected in 2016. Conclusions: This protocol offers a framework for the design and analysis of a personalized health IT system that has the potential to increase patient and caregiver engagement in acute care, hospital-based contexts.

  • Patient and nurse interaction. (Modified from; Permission details, Reuse Restrictions None - This image is in the public domain and can be freely reused).

    Using Computational Approaches to Improve Risk-Stratified Patient Management: Rationale and Methods


    Background: Chronic diseases affect 52% of Americans and consume 86% of health care costs. A small portion of patients consume most health care resources and costs. More intensive patient management strategies, such as case management, are usually more effective at improving health outcomes, but are also more expensive. To use limited resources efficiently, risk stratification is commonly used in managing patients with chronic diseases, such as asthma, chronic obstructive pulmonary disease, diabetes, and heart disease. Patients are stratified based on predicted risk with patients at higher risk given more intensive care. The current risk-stratified patient management approach has 3 limitations resulting in many patients not receiving the most appropriate care, unnecessarily increased costs, and suboptimal health outcomes. First, using predictive models for health outcomes and costs is currently the best method for forecasting individual patient’s risk. Yet, accuracy of predictive models remains poor causing many patients to be misstratified. If an existing model were used to identify candidate patients for case management, enrollment would miss more than half of those who would benefit most, but include others unlikely to benefit, wasting limited resources. Existing models have been developed under the assumption that patient characteristics primarily influence outcomes and costs, leaving physician characteristics out of the models. In reality, both characteristics have an impact. Second, existing models usually give neither an explanation why a particular patient is predicted to be at high risk nor suggestions on interventions tailored to the patient’s specific case. As a result, many high-risk patients miss some suitable interventions. Third, thresholds for risk strata are suboptimal and determined heuristically with no quality guarantee. Objective: The purpose of this study is to improve risk-stratified patient management so that more patients will receive the most appropriate care. Methods: This study will (1) combine patient, physician profile, and environmental variable features to improve prediction accuracy of individual patient health outcomes and costs; (2) develop the first algorithm to explain prediction results and suggest tailored interventions; (3) develop the first algorithm to compute optimal thresholds for risk strata; and (4) conduct simulations to estimate outcomes of risk-stratified patient management for various configurations. The proposed techniques will be demonstrated on a test case of asthma patients. Results: We are currently in the process of extracting clinical and administrative data from an integrated health care system’s enterprise data warehouse. We plan to complete this study in approximately 5 years. Conclusions: Methods developed in this study will help transform risk-stratified patient management for better clinical outcomes, higher patient satisfaction and quality of life, reduced health care use, and lower costs.

  • Word Cloud. Sherry Pagoto created the image using, and holds the copyright.

    Twitter-Delivered Behavioral Weight-Loss Interventions: A Pilot Series


    Background: Lifestyle interventions are efficacious at reducing risk for diabetes and cardiovascular disease but have not had a significant public health impact given high cost and patient and provider burden. Objective: Online social networks may reduce the burden of lifestyle interventions to the extent that they displace in-person visits and may enhance opportunities for social support for weight loss. Methods: We conducted an iterative series of pilot studies to evaluate the feasibility and acceptability of using online social networks to deliver a lifestyle intervention. Results: In Study 1 (n=10), obese participants with depression received lifestyle counseling via 12 weekly group visits and a private group formed using the online social network, Twitter. Mean weight loss was 2.3 pounds (SD 7.7; range -19.2 to 8.2) or 1.2% (SD 3.6) of baseline weight. A total of 67% (6/9) of participants completing exit interviews found the support of the Twitter group at least somewhat useful. In Study 2 (n=11), participants were not depressed and were required to be regular users of social media. Participants lost, on average, 5.6 pounds (SD 6.3; range -15 to 0) or 3.0% (SD 3.4) of baseline weight, and 100% (9/9) completing exit interviews found the support of the Twitter group at least somewhat useful. To explore the feasibility of eliminating in-person visits, in Study 3 (n=12), we delivered a 12-week lifestyle intervention almost entirely via Twitter by limiting the number of group visits to one, while using the same inclusion criteria as that used in Study 2. Participants lost, on average, 5.4 pounds (SD 6.4; range -14.2 to 3.9) or 3.0% (SD 3.1) of baseline weight, and 90% (9/10) completing exit interviews found the support of the Twitter group at least somewhat useful. Findings revealed that a private Twitter weight-loss group was both feasible and acceptable for many patients, particularly among regular users of social media. Conclusions: Future research should evaluate the efficacy and cost-effectiveness of online social network-delivered lifestyle interventions relative to traditional modalities.

  • Application in use (Image taken by the authors who hold the copyright).

    Effectiveness of a Mobile Phone App for Adults That Uses Physical Activity as a Tool to Manage Cigarette Craving After Smoking Cessation: A Study Protocol...


    Background: Results from studies on the effects of exercise on smoking-related variables have provided strong evidence that physical activity acutely reduces cigarette cravings. Mobile technology may provide some valuable tools to move from explanatory randomized controlled trials to pragmatic randomized controlled trials by testing the acute effectiveness of exercise on quitters under real-life conditions. An mHealth app was developed to be used as a support tool for quitters to manage their cigarette cravings. Objective: The primary aim of this paper is to present the protocol of a study examining the effectiveness of the Physical over smoking app (Ph.o.S) by comparing the point prevalence abstinence rate of a group of users to a comparator group during a 6-month follow-up period. Methods: After initial Web-based screening, eligible participants are recruited to attend a smoking cessation program for 3 weeks to set a quit smoking date. Fifty participants who succeed in quitting will be randomly allocated to the comparator and experimental groups. Both groups will separately have 1 more counseling session on how to manage cravings. In this fourth session, the only difference in treatment between the groups is that the experimental group will have an extra 10-15 minutes of guidance on how to use the fully automated Ph.o.S app to manage cravings during the follow-up period. Data will be collected at baseline, as well as before and after the quit day, and follow-up Web-based measures will be collected for a period of 6 months. The primary efficacy outcome is the 7-day point prevalence abstinence rate, and secondary efficacy outcomes are number of relapses and cravings, self-efficacy of being aware of craving experience, self-efficacy in managing cravings, and power of control in managing cravings. Results: Recruitment for this project commenced in December 2014, and proceeded until May 2015. Follow-up data collection has commenced and will be completed by the end of December 2015. Conclusions: If the Ph.o.S app is shown to be effective, the study will provide evidence for the use of the app as a support tool for people who are trying to manage cravings during smoking cessation programs. It is anticipated that the results of the study will provide knowledge of how physical activity affects cigarette craving in real-life situations and inform the development and delivery of relapse prevention in smoking cessation treatment. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN55259451; (Archived by WebCite at

  • Image of the experimental set up taken by Dr.Szturm and can be reprinted with permission by Dr.Szturm.

    Games and Telerehabilitation for Balance Impairments and Gaze Dysfunction: Protocol of a Randomized Controlled Trial


    Background: Digital media and gaming have received considerable interest from researchers and clinicians as a model for learning a broad range of complex tasks and facilitating the transfer of skills to daily life. These emerging rehabilitation technologies have the potential to improve clinical outcomes and patient participation because they are engaging, motivating, and accessible. Our research goal is to develop preventative and therapeutic point-of-care eHealth applications that will lead to equivalent or better long-term health outcomes and health care costs than existing programs. We have produced a novel computer-aided tele-rehabilitation platform that combines computer game-based exercises with tele-monitoring. Objective: Compare the therapeutic effectiveness of an in-home, game-based rehabilitation program (GRP) to standard care delivered in an outpatient physical therapy clinic on measures of balance, gaze control, dizziness, and health-related quality of life. Methods: A randomized, controlled, single-blind pilot trial will be conducted. Fifty-six participants with a diagnosis of peripheral vestibular disorder will be randomly assigned to either usual physical therapy (comparator group) or to a game-based intervention (experimental group). Measures to be assessed will include gaze control, dynamic balance, and self-reported measures of dizziness. Results: The project was funded and enrollment was started in August 2014. To date, 36 participants have been enrolled. There have been 6 drop-outs. It is expected that the study will be completed January 2016 and the first results are expected to be submitted for publication in Spring of 2016. Conclusions: A successful application of this rehabilitation program would help streamline rehabilitation services, leverage therapist time spent with clients, and permit regular practice times at the client’s convenience. Trial Registration: NCT02134444; (Archived by WebCite at

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  • Health Systems Readiness to Manage the Hypertension Epidemic in the Primary Health Care Facilities in the Western Cape, South Africa.

    Date Submitted: Nov 25, 2015

    Open Peer Review Period: Nov 25, 2015 - Dec 9, 2015

    Background. Developing countries are undergoing a process of epidemiological transition from infectious to non-communicable diseases, described by the United Nations Secretary General Ban Ki-Moon as...

    Background. Developing countries are undergoing a process of epidemiological transition from infectious to non-communicable diseases, described by the United Nations Secretary General Ban Ki-Moon as ''a public health emergency in slow motion". One of the most prevalent in sub-Saharan Africa is hypertension, which is a complex chronic condition often referred to as the "silent killer" and a key contributor to the development of cardiovascular and cerebrovascular diseases. Hypertensive patients in this setting are estimated to increase from 74.7 million in 2008 to 125.5 million in 2025, a 68% increase. However, there is an important gap between emerging high-level policies and recommendations, and the near-absence of practical guidance and experience delivering long-term medical care for non-communicable diseases within resources-limited health systems. To address this gap, our study will consist of field investigations to determine the minimum health systems requirements to ensure successful delivery of antihypertensive medications when scaling-up interventions to control the hypertension epidemic. Methods/Design. A cross-sectional analytic study will be conducted in the Western Cape using a mix method approach with two semi-structured interview guides. One for health professionals involved in the care of hypertensive patients within at least six community health centers (three urban and three rural) to understand the challenges associated with their care. The other will be to map and assess the current supply chain management system of antihypertensive medications by interviewing key informants at different levels of the processes. Finally modeling and simulation tools will be used to estimate minimum numbers of health workers required at each supply chain interval to ensure successful delivery of medications when scaling up interventions. Discussion. This investigation will highlight the detailed processes in place for the care of hypertensive patients in primary health care facilities thus identifying the challenges. It will also describe the drug supply chain management systems in place and identify its strengths and weaknesses. The findings along with the estimates form the modeling and simulation will inform the health system minimum requirement to scale up interventions to manage and control the hypertension epidemic in the Western Cape province of South Africa.

  • Using technology to help low-income and Latino smokers quit

    Date Submitted: Nov 21, 2015

    Open Peer Review Period: Nov 21, 2015 - Dec 5, 2015

    Background: The Institute for International Internet Interventions for Health at Palo Alto University proposes to develop digital tools specifically designed to help low income English-speaking and Sp...

    Background: The Institute for International Internet Interventions for Health at Palo Alto University proposes to develop digital tools specifically designed to help low income English-speaking and Spanish-speaking smokers to quit. Individuals from lower-income countries and those with lower social status quit at lower rates than those from high-income countries and those with higher social status. Objective: We plan to launch a project designed to test whether a mobile-based digital intervention designed with systematic input from low-income English- and Spanish-speaking smokers from a public sector health care system can significantly improve its acceptability, utilization, and effectiveness. Methods: Using human-centered development methods, we will involve low-income patients in the design of a web app/text messaging tool. We will also use their input to improve our recruitment and dissemination strategies. We will iteratively develop successive versions of the digital interventions informed by our human-centered approach. The project involves three specific aims: 1) Human-centered development of an English/Spanish smoking cessation web app. We will develop iterative versions of a digital smoking cessation tool (a web app with text messaging components) that is highly responsive to the needs and preferences of low-income English- and Spanish-speaking smokers. 2) Improvement of dissemination strategies. Input from participants will identify effective ways of reaching and encouraging low-income English- and Spanish-speaking smokers to use the digital smoking cessation interventions to be developed.This information will support ongoing dissemination and implementation efforts beyond the grant period. 3) Evaluation of resulting smoking cessation web app. We will evaluate the effectiveness of the successive versions of the resulting stop smoking web app by an online randomized controlled trial. Increased effectiveness will be defined as 1) increased utilization of the web app and 2) higher abstinence rates than those obtained by a baseline “usual care” web app. Results: By obtaining systematic input from smokers from this disproportionately impacted population, we hope to develop a digital tool that will be more likely to be used by low-income smokers, including Latino smokers, and that will have a greater likelihood of obtaining quit rates that are comparable to those reported for other smoking cessation methods. Conclusions: We plan to develop and test an English/Spanish smoking cessation web app for low income population. Using human-centered development methods, we will improve the design of a web app/text messaging tool, and our recruitment and dissemination strategies. We will then test the effectiveness of the resulting stop smoking web app by an online randomized controlled trial. By obtaining systematic input from smokers from this disproportionately impacted population, we hope to develop a digital tool that will be more likely to be used by low-income smokers, including Latino smokers, and that will have a greater likelihood of obtaining quit rates that are comparable to those reported for other smoking cessation methods.

  • Use of Subperiosteal Drain versus Subdural Drain in Chronic Subdural Hematomas treated with Burr-Hole Trepanation: study protocol for a randomized controlled trial

    Date Submitted: Nov 12, 2015

    Open Peer Review Period: Nov 13, 2015 - Nov 27, 2015

    Background: Chronic subdural hematoma (cSDH) is one of the most frequent neurosurgical entities, affecting elderly people and associated with substantial morbidity and mortality. The use of a subdural...

    Background: Chronic subdural hematoma (cSDH) is one of the most frequent neurosurgical entities, affecting elderly people and associated with substantial morbidity and mortality. The use of a subdural drain after burr-hole trepanation for cSDH was proven to reduce recurrence and mortality at 6 months. To date in neurosurgery practice evidence based guidelines on what kind of drain should be used, namely a subdural or subperiosteal drain, do not exist. Currently both methods are being practiced depending on the institute and/or the practicing neurosurgeon. Objective: The aim of this study is to compare the reoperation rates after burr-hole trepanation and insertion of a subperiosteal or subdural drain in patients with cSDH. Methods: This is a prospective, non-inferiority, multi-center, RCT designed to include 220 patients above the age of 18 years, presenting with a symptomatic cSDH verified on cranial CT or MRI, who are to undergo surgical evacuation with burr-hole trepanation. After obtaining informed consent patients are randomly allocated to a subperiosteal drain (SPD) group or a subdural drain (SDD) group. The primary endpoint is recurrence indicating a reoperation within 12 months. Results: This research is investigator initiated and received ethics approval. Patient recruitment started in April 2013, and we expect all study-related activities to be completed by the end of 2016/beginning of 2017. Results: The study is a currently on-going study in two Neurosurgical centers: Kantonsspital Aarau (KSA) and University Hospital of Basel (USB). Enrollment began it the end of March 2013. Conclusions: To date evidence based recommendations concerning the operative treatment of cSDH are sparse. Results of this research are expected to have applications in evidence-based practice for the increasing number of patients suffering from cSDH and possibly lead to more efficient treatment of this disease with less postoperative complications. Clinical Trial: NCT01869855.

  • Design and Development of a Clinical Risk Management Tool Using Radio Frequency Identification RFID

    Date Submitted: Oct 30, 2015

    Open Peer Review Period: Nov 3, 2015 - Dec 30, 2015

    Background: Patient safety is one of the most important elements of quality of healthcare. It means preventing any harm to the patients during medical care process Objective: This paper introduces a c...

    Background: Patient safety is one of the most important elements of quality of healthcare. It means preventing any harm to the patients during medical care process Objective: This paper introduces a cost-effective tool in which the Radio Frequency Identification (RFID) technology is used to identify medical errors in hospital. Methods: The proposed clinical error management system (CEMS) is consisted of a reader device, a transfer/receiver device, a database and managing software. The reader device works using radio waves and is wireless. The reader sends and receives data to/from the database via the transfer/receiver device which is connected to the computer via USB port. The database contains data about patients’ medication orders. Results: The CEMS has the ability to identify the clinical errors before they occur and then warns the care-giver with voice and visual messages to prevent the error. This device reduces the errors and thus improves the patient safety. Conclusions: new tool including software and hardware was developed in this study. Application of this tool in clinical settings can help the nurses prevent medical errors. It can also be a useful tool for clinical risk management. Using this device can improve the patient safety to a considerable extent and thus improve the quality of healthcare.