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 2015: 4.532)

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:

  • Proofmode integrates data from multiple sources into a single research platform. Image created and copyright owned by the Institute for Reproductive Health at Georgetown University. Permission granted to JMIR Research Protocols.

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


    Background: Some 222 million women worldwide have unmet needs for contraception; they want to avoid pregnancy, but are not using a contraceptive method, primarily because of concerns about side effects associated with most available methods. Expanding contraceptive options—particularly fertility awareness options that provide women with information about which days during their menstrual cycles they are likely to become pregnant if they have unprotected intercourse—has the potential to reduce unmet need. Making these methods available to women through their mobile phones can facilitate access. Indeed, many fertility awareness applications have been developed for smartphones, some of which are digital platforms for existing methods, requiring women to enter information about fertility signs such as basal body temperature and cervical secretions. Others are algorithms based on (unexplained) calculations of the fertile period of the menstrual cycle. Considering particularly this latter (largely untested) group, it is critical that these apps be subject to the same rigorous research as other contraceptive methods. Dynamic Optimal Timing, available via the Dot app as a free download for iPhone and Android devices, is one such method and the only one that has published the algorithm that forms its basis. It combines historical cycle data with a woman’s own personal cycle history, continuing to accrue this information over time to identify her fertile period. While Dot has a theoretical failure rate of only 3 in 100 for preventing pregnancy with perfect use, its effectiveness in typical use has yet to be determined. Objective: The study objective is to assess both perfect and typical use to determine the efficacy of the Dot app for pregnancy prevention. Methods: To determine actual use efficacy, the Institute for Reproductive Health is partnering with Cycle Technologies, which developed the Dot app, to conduct a prospective efficacy trial, following 1200 women over the course of 13 menstrual cycles to 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. Results: 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. Conclusions: 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. ClinicalTrial: NCT02833922; (Archived be WebCite at

  • Silver Iphone 6 Near Notebook and Click Pen. Image source: Author: Negative space. Copyright. CC0 License.

    Assessing the Quality, Feasibility, and Efficacy of Electronic Patient Platforms Designed to Support Adolescents and Young Adults With Cancer: A Systematic...


    Background: A range of innovative websites, mobile technologies, eHealth and mHealth platforms have emerged to support adolescents and young adults (AYAs) with cancer. Previous reviews have identified these various applications and solutions, but no review has summarized the quality, feasibility, and efficacy of existing patient platforms (inclusive of websites, mobile technologies, mHealth and eHealth platforms) developed specifically for young people with cancer. Objective: This paper describes the design of a protocol to conduct a review of published studies or reports which describe or report on an existing platform designed specifically for AYAs who have had a cancer diagnosis. Methods: A search string was developed using a variety of key words and Medical Subject Heading and applied to bibliographic databases. General data (sample characteristics, patient platform development, design and, if applicable, pilot testing outcomes) will be extracted from reports and studies. Drawing on a previously developed coding schematic, the identified patient platforms will be coded for mode of delivery into (1) automated functions, (2) communicative functions, and (3) use of supplementary modes. An adapted version of the Mobile App Rating Scale (MARS) will be used to assess the of quality of each identified patient platform. The methodological quality of included studies will be assessed using the Quality Assessment Criteria for Evaluating Primary Research Papers from a Variety of Fields (QualSyst). Both authors will independently screen eligible studies for final inclusion and will both be responsible for data extraction and appraisal. Data will be synthesized narratively to provide an overview of identified patient platforms. Results: The review began in October 2016 and is currently in progress. The review paper will be submitted for peer-review and publication in the summer of 2017. Conclusions: This review will be unique in its focus on assessing, where possible, the quality and efficacy of patient platforms for adolescents and young adults diagnosed with cancer. Results generated from this review will provide an invaluable insight into the utility of modern technology in supporting young people with cancer.

  • The Epital Care Model. Image sourced and copyright owned by authors.

    The Epital Care Model: A New Person-Centered Model of Technology-Enabled Integrated Care for People With Long Term Conditions


    Background: There is worldwide recognition that the future provision of health care requires a reorganization of provision of care, with increased empowerment and engagement of patients, along with skilled health professionals delivering services that are coordinated across sectors and organizations that provide health care. Technology may be a way to enable the creation of a coherent, cocreative, person-centered method to provide health care for individuals with one or more long-term conditions (LTCs). It remains to be determined how a new care model can be introduced that supports the intentions of the World Health Organization (WHO) to have integrated people-centered care. Objective: To design, pilot, and test feasibility of a model of health care for people with LTCs based on a cocreative, iterative, and stepwise process in a way that recognizes the need for person-centered care, and embraces the use of digital technology. Methods: The overall research method was inspired by action research and used an agile, iterative approach. In 2012, a living lab was established in a Danish municipality which allowed for the freedom of redesigning health care processes. As the first step, a wide group of stakeholders was gathered to create a layout for the reorganization of services and development of technology, based on established principles for innovative management of people with chronic conditions. The next three steps were (1) a proof of concept in 2012, (2) a pilot study, and (3) a feasibility study from 2013 to 2015, in which a total of 93 chronic obstructive pulmonary disease (COPD) patients were enrolled. Citizens were provided a tablet-based solution for remote follow-up and communication purposes, and access to a 24/7 response and coordination center that coordinated both virtual and face-to-face support for COPD management. In step five the initial model was extended with elements that support continuity of care. Beginning in the autumn of 2013, 1102 frail elderly individuals were included and offered two additional services: an outgoing acute medical team and a local subacute bed function. Results: Based on the findings from the iterative process, and evolving technology and workflow solutions, we propose a robust and feasible model that can provide a framework for developing solutions to support an active life with one or more LTCs. The resulting Epital Care Model (ECM) consists of six stages, and serves as a template for how a digitally-enhanced health service can be provided based on patients’ medical needs. The model is designed to be a proactive, preventive, and monitoring health care system that involves individuals in the management of their own health conditions. Conclusions: The ECM is in accordance with WHO’s framework for integrated people-centered health services, and may serve as a framework for the development of new technologies and provide a template for future reorganization.

  • KIU Bar. Image sourced and copyright owned by authors.

    Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized...


    Background: Human immunodeficiency virus (HIV) infections are increasing among young men who have sex with men (YMSM), yet few HIV prevention programs have studied this population. Keep It Up! (KIU!), an online HIV prevention program tailored to diverse YMSM, was developed to fill this gap. The KIU! 2.0 randomized controlled trial (RCT) was launched to establish intervention efficacy. Objective: The objective of the KIU! study is to advance scientific knowledge of technology-based behavioral HIV prevention, as well as improve public health by establishing the efficacy of an innovative electronic health (eHealth) prevention program for ethnically and racially diverse YMSM. The intervention is initiated upon receipt of a negative HIV test result, based on the theory that testing negative is a teachable moment for future prevention behaviors. Methods: This is a two-group, active-control RCT of the online KIU! intervention. The intervention condition includes modules that use videos, animation, games, and interactive exercises to address HIV knowledge, motivation for safer behaviors, self-efficacy, and behavioral skills. The control condition reflects HIV information that is readily available on many websites, with the aim to understand how the KIU! intervention improves upon information that is currently available online. Follow-up assessments are administered at 3, 6, and 12 months for each arm. Testing for urethral and rectal sexually transmitted infections (STIs) is completed at baseline and at 12-month follow-up for all participants, and at 3- and 6-month follow-ups for participants who test positive at baseline. The primary behavioral outcome is unprotected anal sex at all follow-up points, and the primary biomedical outcome is incident STIs at 12-month follow-up. Results: Consistent with study aims, the KIU! technology has been successfully integrated into a widely-used health technology platform. Baseline enrollment for the RCT was completed on December 30, 2015 (N=901), and assessment of intervention outcomes is ongoing at 3-, 6-, and 12-month time points. Upon collection of all data, and after the efficacy of the intervention has been evaluated, we will explore whether the KIU! intervention has differential efficacy across subgroups of YMSM based on ethnicity/race and relationship status. Conclusions: Our approach is innovative in linking an eHealth solution to HIV and STI home testing, as well as serving as a model for integrating scalable behavioral prevention into other biomedical prevention strategies. Trial Registration: NCT01836445; (Archived by WebCite at

  • Acupuncture. Image source: Author: ふぉぐ Copyright:Creative Commons Attribution-Share Alike 3.0 Unported.

    Acupuncture for Children with Cerebral Palsy: A Systematic Review Protocol


    Background: Cerebral palsy (CP), a childhood disease of high morbidity and serious harmfulness, has no effective therapies to completely relieve the associated pain. Acupuncture has been used widely in China to alleviate several CP symptoms, such as pain and motion disorders, despite the deficiency of high-quality evidence related to this practice. Objective: The aim of this systematic review protocol is to assess the efficacy and safety of acupuncture for the treatment of children with CP. Methods: The following electronic databases will be searched: Cochrane Library, Web of Science, EBASE, Springer, World Health Organization International Clinical Trials Registry Platform, China National Knowledge Infrastructure, Wan-fang database, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, and other sources. All published randomized controlled trials from inception to December 2016 will be included. RevMan V.5.3 software will be implemented for the assessment of bias risk, data synthesis, subgroup analysis, and meta-analyses if inclusion conditions are met. Individuals recruited into the trials will include children with all types of CP, and these individuals will be involved as coresearchers to develop and evaluate the efficacy and safety of acupuncture for the treatment of children with CP. Due to language barriers, only English and Chinese articles will be retrieved. Results: The systematic review will synthesize the available knowledge surrounding acupuncture for children with CP. The findings will be synthesized to determine the efficacy and safety of acupuncture for children with CP. Conclusions: The review has not been completed. This protocol presents a proper method to implement the systematic review, and ensures transparency for the completed review. Findings from the systematic review will be disseminated in a peer-reviewed journal and results will be presented at relevant conferences. The data of individual patients will not be included, so ethical approval is not required. Trial Registration: PROSPERO registration number: CRD42016038275, (Archived by WebCite at http://www.webcitation/6nGxoJrqm

  • PsicAP. Image sourced and copyright owned by authors.

    Transdiagnostic Cognitive Behavioral Therapy Versus Treatment as Usual in Adult Patients With Emotional Disorders in the Primary Care Setting (PsicAP Study):...


    Background: Demand for primary care (PC) services in Spain exceeds available resources. Part of this strong demand is due to the high prevalence of emotional disorders (EDs)—anxiety, depression, and somatic symptom disorders—and related comorbidities such as pain or chronic illnesses. EDs are often under- or misdiagnosed by general practitioners (GPs) and, consequently, treatment is frequently inadequate. Objective: We aim to compare the short- and long-term effectiveness of group-delivered transdiagnostic cognitive behavioral therapy (TD-CBT) versus treatment as usual (TAU) in the treatment of EDs in the PC setting in Spain. We also aim to compare the effect of these treatments on disability, quality of life, cognitive-emotional factors, and treatment satisfaction. Methods: Here we present the study design of a two-arm, single-blind, randomized controlled trial (N=1126) to compare TAU to TD-CBT for EDs. TAU will consist primarily of pharmacological treatment and practical advice from the GP while TD-CBT will be administered in seven 90-minute group sessions held over a period ranging from 12 to 14 weeks. Psychological assessments are carried out at baseline (ie, pretreatment); posttreatment; and at 3-, 6-, and 12-month follow-up. The study is conducted in approximately 26 PC centers from the National Health System in Spain. Results: This study was initiated in December 2013 and will remain open to new participants until recruitment and follow-up has been completed. We expect all posttreatment evaluations to be completed by December 2017, and follow-up will end in December 2018. Conclusions: We expect the TD-CBT group to have better results compared to TAU on all posttreatment measures and that this improvement will be maintained during follow-up. This project could serve as a model for use in other areas or services of the National Health System in Spain and even in other countries. ClinicalTrial: International Standard Randomized Controlled Trial Number (ISRCTN): 58437086; (Archived by WebCite at

  • Deep Brain Stimulation. Image sourced and copyright owned by authors.

    Deep Brain Stimulation for Tremor Tractographic Versus Traditional (DISTINCT): Study Protocol of a Randomized Controlled Feasibility Trial


    Background: Essential tremor is a movement disorder that can result in profound disability affecting the quality of life. Medically refractory essential tremor can be successfully reduced by deep brain stimulation (DBS) traditionally targeting the thalamic ventral intermediate nucleus (Vim). Although this structure can be identified with magnetic resonance (MR) imaging nowadays, Vim-DBS electrodes are still implanted in the awake patient with intraoperative tremor testing to achieve satisfactory tremor control. This can be attributed to the fact that the more effective target of DBS seems to be the stimulation of fiber tracts rather than subcortical nuclei like the Vim. There is evidence that current coverage of the dentatorubrothalamic tract (DRT) results in good tremor control in Vim-DBS. Diffusion tensor MR imaging (DTI) tractography-assisted stereotactic surgery targeting the DRT would therefore not rely on multiple trajectories and intraoperative tremor testing in the awake patient, bearing the potential of more patient comfort and reduced operation-related risks. This is the first randomized controlled trial comparing DTI tractography-assisted stereotactic surgery targeting the DRT in general anesthesia with stereotactic surgery of thalamic/subthalamic region as conventionally used. Objective: This clinical pilot trial aims at demonstrating safety of DTI tractography-assisted stereotactic surgery in general anesthesia and proving its equality compared to conventional stereotactic surgery with intraoperative testing in the awake patient. Methods: The Deep Brain Stimulation for Tremor Tractographic Versus Traditional (DISTINCT) trial is a single-center investigator-initiated, randomized, controlled, observer-blinded trial. A total of 24 patients with medically refractory essential tremor will be randomized to either DTI tractography-assisted stereotactic surgery targeting the DRT in general anesthesia or stereotactic surgery of the thalamic/subthalamic region as conventionally used. The primary objective is to assess the tremor reduction, obtained by the Fahn-Tolosa-Marin Tremor Rating Scale in the 2 treatment groups. Secondary objectives include (among others) assessing the quality of life, optimal electrode contact positions, and safety of the intervention. The study protocol has been approved by the independent ethics committee of the University of Freiburg. Results: Recruitment to the DISTINCT trial opened in September 2015 and is expected to close in June 2017. At the time of manuscript submission the trial is open to recruitment. Conclusions: The DISTINCT trial is the first to compare DTI tractography-assisted stereotactic surgery with target point of the DRT in general anesthesia to stereotactic surgery of the thalamic/subthalamic region as conventionally used. It can serve as a cornerstone for the evolving technique of DTI tractography-assisted stereotactic surgery. ClinicalTrial: NCT02491554; (Archived by WebCite at German Clinical Trials Register DRKS00008913; (Archived by WebCite at

  • FacharztPlus. Image sourced and copyright owned by authors.

    Securing the Continuity of Medical Competence in Times of Demographic Change: A Proposal


    Background: University hospitals make up the backbone of medical and economic services of hospitals in Germany: they qualify specialist physicians, ensure medical research, and provide highly specialized maximum medical care, which other hospitals cannot undertake. In addition to this assignment, medical research and academic teaching must be managed despite a growing shortage of specialist physicians. By the year 2020, the need for the replacement of retired physicians and increased demand will total 30,000 positions. The situation will become more difficult because, on the whole, patients are becoming older and sicker and because specialist physicians are able to find more attractive working conditions in smaller hospitals, abroad, or outside of curative medicine. Objective: In order to retain sufficient qualified employees, major improvements in quality are required in terms of working and training conditions. For this purpose, a sustainable innovation process is necessary, which incorporates solutions from outside of the health care sector in order to be able to learn from experiences and mistakes from other industries. The FacharztPlus project aims to find suitable measures in order to retain specialist physicians for more years after the completion of 5 years of professional training. This should determine the suitability of additional qualifications alongside the professional career and an expertise-related work organization oriented to different stages of life. Methods: Structured interviews, surveys, and repertory grids are used as preparation for cross-industry expert panels to create future work scenarios for university hospitals. Industries involved are harbor logistics (container terminal), airports, and digitized industrial production (“industry 4.0”) because these industries are also facing a shortage of qualified staff and have to respond to rapidly changing demands. Based on the experts’ scenarios, consensus groups will be established in each university hospital trying to reach consensus about the implementation of relevant factors in order to improve employee retention. Results: We expect these consensus groups to develop and introduce measures for more structured training procedures, individual and team incentives, organizational guidelines for better recruiting and retention in hospitals, models of flexible and attractive working conditions including shift work and vacation planning, and use of new learning tools (eg, tablet PCs and mobile phones). Conclusions: All measures are implemented in the Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine at the University Hospital Muenster (UKM) with approximately 150 physicians and in the further 44 departments of the UKM and 22 teaching hospitals, which all together employ more than 5000 physicians. The measures will also be implemented at the university hospitals in Aachen, Rostock, and Greifswald. All decisions and measures will be discussed with representatives from hospital management and professional associations. Results will be presented at conferences and published in journals.

  • Activity tracker. Image sourced and copyright owned by authors.

    Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures:...


    Background: Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. Objective: With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. Methods: This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle. Results: The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted. Conclusions: We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower. ClinicalTrial: Netherlands Trial Registry NTC4699; (Archived by WebCite at

  • Using patient flow information to determine risk of hospital presentation. Image sourced and copyright owned by authors.

    Using Patient Flow Information to Determine Risk of Hospital Presentation: Protocol for a Proof-of-Concept Study


    Background: Every day, patients are admitted to the hospital with conditions that could have been effectively managed in the primary care sector. These admissions are expensive and in many cases are possible to avoid if early intervention occurs. General practitioners are in the best position to identify those at risk of imminent hospital presentation and admission; however, it is not always possible for all the factors to be considered. A lack of shared information contributes significantly to the challenge of understanding a patient’s full medical history. Some health care systems around the world use algorithms to analyze patient data in order to predict events such as emergency presentation; however, those responsible for the design and use of such systems readily admit that the algorithms can only be used to assess the populations used to design the algorithm in the first place. The United Kingdom health care system has contributed data toward algorithm development, which is possible through the unified health care system in place there. The lack of unified patient records in Australia has made building an algorithm for local use a significant challenge. Objective: Our objective is to use linked patient records to track patient flow through primary and secondary health care in order to develop a tool that can be applied in real time at the general practice level. This algorithm will allow the generation of reports for general practitioners that indicate the relative risk of patients presenting to an emergency department. Methods: A previously designed tool was used to deidentify the general practice and hospital records of approximately 100,000 patients. Records were pooled for patients who had attended emergency departments within the Eastern Health Network of hospitals and general practices within the Eastern Health Network catchment. The next phase will involve development of a model using a predictive analytic machine learning algorithm. The model will be developed iteratively, testing the combination of variables that will provide the best predictive model. Results: Records of approximately 97,000 patients who have attended both a general practice and an emergency department have been identified within the database. These records are currently being used to develop the predictive model. Conclusions: Records from general practice and emergency department visits have been identified and pooled for development of the algorithm. The next phase in the project will see validation and live testing of the algorithm in a practice setting. The algorithm will underpin a clinical decision support tool for general practitioners which will be tested for face validity in this initial study into its efficacy.

  • Alcohol. Image Source: Author: Tookapic. Copyright: CC0 License.

    Investigation of the Association Between Alcohol Outlet Density and Alcohol-Related Hospital Admission Rates in England: Study Protocol


    Background: Availability of alcohol is a major policy issue for governments, and one of the availability factors is the density of alcohol outlets within geographic areas. Objective: The aim of this study is to investigate the association between alcohol outlet density and hospital admissions for alcohol-related conditions in a national (English) small area level ecological study. Methods: This project will employ ecological correlation and cross-sectional time series study designs to examine spatial and temporal relationships between alcohol outlet density and hospital admissions. Census units to be used in the analysis will include all Lower and Middle Super-Output Areas (LSOAs and MSOAs) in England (53 million total population; 32,482 LSOAs and 6781 MSOAs). LSOAs (approximately 1500 people per LSOA) will support investigation at a fine spatial resolution. Spatio-temporal associations will be investigated using MSOAs (approximately 7500 people per MSOA). The project will use comprehensive coverage data on alcohol outlets in England (from 2003, 2007, 2010, and 2013) from a commercial source, which has estimated that the database includes 98% of all alcohol outlets in England. Alcohol outlets may be classified into two broad groups: on-trade outlets, comprising outlets from which alcohol can be purchased and consumed on the premises (eg, pubs); and off-trade outlets, in which alcohol can be purchased but not consumed on the premises (eg, off-licenses). In the 2010 dataset, there are 132,989 on-trade and 51,975 off-trade outlets. The longitudinal data series will allow us to examine associations between changes in outlet density and changes in hospital admission rates. The project will use anonymized data on alcohol-related hospital admissions in England from 2003 to 2013 and investigate associations with acute (eg, admissions for injuries) and chronic (eg, admissions for alcoholic liver disease) harms. The investigation will include the examination of conditions that are wholly and partially attributable to alcohol, using internationally standardized alcohol-attributable fractions. Results: The project is currently in progress. Results are expected in 2017. Conclusions: The results of this study will provide a national evidence base to inform policy decisions regarding the licensing of alcohol sales outlets.

  • Stigma study logo. Image sourced and copyright owned by authors.

    Stigma and Its Impact on Glucose Control Among Youth With Diabetes: Protocol for a Canada-Wide Study


    Background: Stigma in chronic disease involves unwarranted rejection, judgement, or exclusion by others based on the chronic disease itself. Objective: We aim to determine the prevalence of stigma among youth and young adults with type 1 diabetes in Canada, to assess associations between stigma and glycemic control, and to explore ways to address stigma related to type 1 diabetes. Methods: The study includes 3 distinct phases: (1) refinement of survey questions, (2) assessment of test-retest reliability, and (3) a data collection and analysis phase (online survey and mailed-in capillary blood sample to assess hemoglobin A1c). A total of 380 youth and young adults (14 to 24 years old) with type 1 diabetes are being recruited through social media and clinic posters. Results: Phases 1 and 2 are complete, and phase 3 is in progress. Thirty participants completed phase 2. The survey includes the Barriers to Diabetes Adherence in adolescent scale (intraclass correlation [ICC]=0.967, 95% CI 0.931-0.984), the Self-Efficacy for Diabetes Self-Management measure (ICC=0.952, 95% CI 0.899-0.977), the World Health Organization-5 Well-Being Index (ICC=0.860, 95% CI 0.705-0.933), 12 closed-ended questions, and an additional 5 open-ended questions to explore challenges and solutions developed by the team of experts, including a patient representative. Conclusions: This will be the first large-scale survey to estimate the prevalence of stigma in young people with type 1 diabetes. The results of this study will allow for an appreciation of the magnitude of the problem and the need for developing and implementing solutions. This work is intended to provide an initial understanding of youth perspectives on the challenges of living with type 1 diabetes and will serve as a foundation for future research and action to help youth improve their experience of living with diabetes. Trial Registration: NCT02796248, (Archived at

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  • Usability Testing and Validation of ISO DIS 19223 for Lung Ventilators

    Date Submitted: Jan 10, 2017

    Open Peer Review Period: Jan 18, 2017 - Feb 1, 2017

    Background: Clinicians, such as respiratory therapists and physicians, are often required to set up medical equipment which use inconsistent terminology. Current lung ventilator terminology used by di...

    Background: Clinicians, such as respiratory therapists and physicians, are often required to set up medical equipment which use inconsistent terminology. Current lung ventilator terminology used by different manufacturers contributes to the risk of use error and in turn the risk of ventilator associated lung injury and other conditions. Issues in human factors and communication are often associated with ventilator-related sentinel events. Inconsistent ventilator terminology compounds these issues. This paper describes a proposed protocol which would be implemented at the University of Waterloo when externally funded. Objective: We propose to determine whether a standardized vocabulary improves the ease of use, safety and utility as it relates to the usability of medical devices as compared to legacy medical devices from multiple manufacturers that use different terms. Methods: We hypothesize that use errors by clinicians will be lower when standardization is consistently applied by all manufacturers. The proposed study will experimentally examine the impact of standardized nomenclature on performance declines in the use of an unfamiliar ventilator product in clinically relevant scenarios. Participants will be respiratory therapy practitioners and trainees. Results: The protocol will be implemented in the near future. We propose studying approximately 60 participants. Conclusions: The proposed study will help better understand the effect of standardization on medical device usability. The study will also help identify any terms in the ISO Draft International Standard (DIS) 19223 that may be associated with recurrent errors, which would necessitate an amendment to the standard. This report makes two contributions; it proposes a protocol that can be used to assess the effect of standardization in any given domain involving equipment, multiple manufacturers, and inconsistent vocabulary, symbology, audio tones or patterns in interface navigation. Secondly, the protocol can be used to experimentally evaluate the ISO DIS 19223 for its effectiveness as researchers around the world may wish to conduct such tests and compare results.

  • January 14, 2016 Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans with Coronary Heart Disease (Mobile4Meds): Study Protocol of a Mixed-Methods Study

    Date Submitted: Jan 14, 2017

    Open Peer Review Period: Jan 18, 2017 - Feb 1, 2017

    Background: Adherence to antiplatelet medications is critical to prevent life threatening complications (i.e., stent thrombosis); yet rates of non-adherence range from 21-57% by 12 months. Mobile tech...

    Background: Adherence to antiplatelet medications is critical to prevent life threatening complications (i.e., stent thrombosis); yet rates of non-adherence range from 21-57% by 12 months. Mobile technology through text messaging (TM) or mobile applications (apps) is a practical and inexpensive strategy to promote behavior change and enhance medication adherence. Objective: The Mobile4Meds study seeks to determine whether TM 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 or percutaneous coronary intervention (ACS/PCI). The three aims are to: 1) determine preferences for content and frequency of TM to promote medication adherence through focus groups; 2) determine the most patient-centered app to promote 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 Veterans post ACS/PCI through a randomized clinical trial (RCT). Methods: We will use a mixed methods design that uses focus groups to achieve the first and second aims (N=32). Patients, who are randomly assigned to one of three arms: 1) customized TM, 2) mobile app, 3) website-control groups (N=225), will be followed for 12 months. Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-report. Results: Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. Conclusions: Determining the efficacy of mobile technology through 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. Clinical Trial: Identifier: NCT03022669

  • Ivermectin treatment in patients with onchocerciasis-associated epilepsy: a randomized clinical trial

    Date Submitted: Dec 19, 2016

    Open Peer Review Period: Dec 19, 2016 - Feb 13, 2017

    Background: Many studies have reported an association between epilepsy, including Nodding Syndrome (NS), and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted particularly...

    Background: Many studies have reported an association between epilepsy, including Nodding Syndrome (NS), and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or insufficiently controlled with mass Ivermectin distribution. There is evidence that increasing the coverage of Ivermectin reduces the incidence of epilepsy and anecdotal evidence suggests a reduction in seizure frequency in onchocerciasis associated epilepsy (OAE) patients who receive Ivermectin. Finding an alternative treatment for epilepsy in these patients will have major consequences. Objective: To assess whether Ivermectin treatment leads to seizure freedom in OAE patients, including patients with NS. Methods: We will conduct a randomized clinical trial in the Democratic Republic of Congo (DRC) to compare seizure freedom in onchocerciasis infested epilepsy patients who receive immediate Ivermectin treatment with delayed (after four months) Ivermectin treatment. All participants will simultaneously receive anti-epileptic drugs (AEDs) according to local guidelines for epilepsy treatment. The primary endpoint is seizure freedom defined as no seizures during the fourth month of follow-up. Secondary endpoint is significant (>50%) seizure reduction compared to baseline seizure frequency. Results: Start of enrolment is planned from March 2017 and we expect to have enrolled all 110 participants by August 2017. Results are expected by the end of 2017. Conclusions: If Ivermectin treatment, in addition to AEDs, is able to lead to seizure freedom or significantly reduces seizure frequency in OAE patients this will have major consequences for epilepsy treatment in Onchocerciasis endemic regions. Ivermectin is donated for free, and in non Loa-Loa endemic regions has negligible side effects. Reducing the burden of epilepsy will have a major impact on quality of life and socio-economic status of families with affected members in Africa. Clinical Trial: WHO International Registry Network