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:

  • Teaching Intuitive Eating and Acceptance and Commitment Therapy Skills Via a Web-Based Intervention: A Pilot Single-Arm Intervention Study


    Background: Middle-aged women are at risk of weight gain and associated comorbidities. Deliberate restriction of food intake (dieting) produces short-term weight loss but is largely unsuccessful for long-term weight management. Two promising approaches for the prevention of weight gain are intuitive eating (ie, eating in accordance with hunger and satiety signals) and the development of greater psychological flexibility (ie, the aim of acceptance and commitment therapy [ACT]). Objectives: This pilot study investigated the usage, acceptability, and feasibility of “Mind, Body, Food,” a Web-based weight gain prevention intervention prototype that teaches intuitive eating and psychological flexibility skills. Methods: Participants were 40 overweight women (mean age 44.8 [standard deviation, SD, 3.06] years, mean body mass index [BMI] 32.9 [SD 6.01] kg/m2, mean Intuitive Eating Scale [IES-1] total score 53.4 [SD 7.46], classified as below average) who were recruited from the general population in Dunedin, New Zealand. Module completion and study site metrics were assessed using Google Analytics. Use of an online self-monitoring tool was determined by entries saved to a secure online database. Intervention acceptability was assessed postintervention. BMI, intuitive eating, binge eating, psychological flexibility, and general mental and physical health were assessed pre- and postintervention and 3-months postintervention. Results: Of the 40 women enrolled in the study, 12 (30%) completed all 12 modules (median 7.5 [interquartile range, IQR, 2-12] modules) and 4 (10%) used the self-monitoring tool for all 14 weeks of the intervention period (median 3 [IQR 1-9] weeks). Among 26 women who completed postintervention assessments, most women rated “Mind, Body, Food” as useful (20/26, 77%), easy to use (17/25, 68%) and liked the intervention (22/25, 88%). From pre- to postintervention, there were statistically significant within-group increases in intuitive eating (IES-2 total score P<.001; all IES-2 subscale scores: P ≤.01), psychological flexibility (P=.01), and general mental health (P<.001) as well as significant decreases in binge eating (P=.01). At the 3-month follow-up, IES-2 improvements were maintained, and there were further improvements in binge eating (P<.001) and general mental health (P=.03), and a marginal yet nonsignificant tendency for further improvement in psychological flexibility (P=.06). There were no significant within-group changes in BMI from pre- to postintervention and postintervention to 3-month follow-up (P=.46 and P=.93, respectively). Conclusions: The “Mind, Body, Food” prototype Web-based intervention is appealing to middle-aged women and may be a useful tool to help women learn intuitive eating and ACT skills, reduce binge eating, and maintain weight over 3 months. Further work to improve the user experience and engagement is required before testing the online intervention in a randomized controlled trial.

  • Porto Novo Hospital-2009. Image created and copyright owned by author Vincent De Brouwere.

    Existing Models of Maternal Death Surveillance Systems: Protocol for a Scoping Review


    Background: Maternal mortality measurement remains a critical challenge, particularly in low and middle income countries (LMICs) where little or no data are available and maternal mortality and morbidity are often the highest in the world. Despite the progress made in data collection, underreporting and translating the results into action are two major challenges that maternal death surveillance systems (MDSSs) face in LMICs. Objective: This paper presents a protocol for a scoping review aimed at synthesizing the existing models of MDSSs and factors that influence their completeness and usefulness. Methods: The methodology for scoping reviews from the Joanna Briggs Institute was used as a guide for developing this protocol. A comprehensive literature search will be conducted across relevant electronic databases. We will include all articles that describe MDSSs or assess their completeness or usefulness. At least two reviewers will independently screen all articles, and discrepancies will be resolved through discussion. The same process will be used to extract data from studies fulfilling the eligibility criteria. Data analysis will involve quantitative and qualitative methods. Results: Currently, the abstracts screening is under way and the first results are expected to be publicly available by mid-2017. The synthesis of the reviewed materials will be presented in tabular form completed by a narrative description. The results will be classified in main conceptual categories that will be obtained during the results extraction. Conclusions: We anticipate that the results will provide a broad overview of MDSSs and describe factors related to their completeness and usefulness. The results will allow us to identify research gaps concerning the barriers and facilitating factors facing MDSSs. Results will be disseminated through publication in a peer-reviewed journal and conferences as well as domestic and international agencies in charge of implementing MDSS.

  • Woman writing in a notebook. Image source:

    A Web-Based Psychosocial Intervention for Family Caregivers of Older People: Results from a Mixed-Methods Study in Three European Countries


    Background: Informal caregiving is the main source of care for older people in Europe. An enormous amount of responsibility and care activity is on the shoulders of family caregivers, who might experience problems in their psychological well-being and in reconciling caregiving and their personal sphere. In order to alleviate such burden, there is increasing interest and growing research in Europe on Web-based support addressing family caregivers and their needs. However, the level of development and penetration of innovative Web-based services for caregivers is still quite low and the access to traditional face-to-face services can be problematic for logistic, availability, and quality reasons. Objective: As part of the European project INNOVAGE, a pilot study was conducted for developing and testing a Web-based psychosocial intervention aimed at empowering family caregivers of older people in Italy, Sweden, and Germany. The program offered information resources and interactive services to enable both professional and peer support. Methods: A mixed-methods, sequential explanatory design was adopted. Caregivers’ psychological well-being, perceived negative and positive aspects of caregiving, and social support received were assessed before and after the 3-month intervention. Poststudy, a subsample of users participated in focus groups to assist in the interpretation of the quantitative results. Results: A total of 94 out of 118 family caregivers (79.7%) from the three countries used the Web platform at least once. The information resources were used to different extents in each country, with Italian users having the lowest median number of visits (5, interquartile range [IQR] 2-8), whereas German users had the highest number (17, IQR 7-66) (P<.001). The interactive services most frequently accessed (more than 12 times) in all countries were the social network (29/73, 40%) and private messages (27/73, 37%). The pretest-posttest analysis revealed some changes, particularly the slight worsening of perceived positive values of caregiving (Carers of Older People in Europe [COPE] positive value subscale: P=.02) and social support received (COPE quality-of-support subscale: P=.02; Multidimensional Scale of Perceived Social Support subscale: P=.04), in all cases with small effect size (r range -.15 to -.18). Focus groups were conducted with 20 family caregivers and the content analysis of discussions identified five main themes: online social support, role awareness, caregiving activities, psychological well-being, and technical concerns. The analysis suggested the intervention was useful and appropriate, also stimulating a better self-efficacy and reappraisal of the caregivers’ role. Conclusions: The intervention seemed to contribute to the improvement of family caregivers’ awareness, efficacy, and empowerment, which in turn may lead to a better self-recognition of their own needs and improved efforts for developing and accessing coping resources. A major implication of the study was the finalization and implementation of the InformCare Web platform in 27 European countries, now publicly accessible (

  • CFAR logo. Image created and copyright owned by authors.

    A Randomized Controlled Trial Protocol to Evaluate the Effectiveness of an Integrated Care Management Approach to Improve Adherence Among HIV-Infected...


    Background: Adherence to antiretroviral medications is a key determinant of clinical outcomes. Many adherence intervention trials investigated the effects of time-intensive or costly interventions that are not feasible in most clinical care settings. Objective: We set out to evaluate a collaborative care approach as a feasible intervention applicable to patients in clinical care including those with mental illness and/or substance use issues. Methods: We developed a randomized controlled trial (RCT) investigating an integrated, clinic-based care management approach to improve clinical outcomes that could be integrated into the clinical care setting. This is based on the routine integration and systematic follow-up of a clinical assessment of patient-reported outcomes targeting adherence, depression, and substance use, and adapts previously developed and tested care management approaches. The primary health coach or care management role is provided by clinic case managers allowing the intervention to be generalized to other human immunodeficiency virus (HIV) clinics that have case managers. We used a stepped-care approach to target interventions to those at greatest need who are most likely to benefit rather than to everyone to maintain feasibility in a busy clinical care setting. Results: The National Institutes of Health funded this study and had no role in study design, data collection, or decisions regarding whether or not to submit manuscripts for publication. This trial is currently underway, enrollment was completed in 2015, and follow-up time still accruing. First results are expected to be ready for publication in early 2017. Discussion: This paper describes the protocol for an ongoing clinical trial including the design and the rationale for key methodological decisions. There is a need to identify best practices for implementing evidence-based collaborative care models that are effective and feasible in clinical care. Adherence efficacy trials have not led to sufficient improvements, and there remains little guidance regarding how adherence interventions should be implemented into clinical care. By focusing on improving adherence within care settings using existing staff, routine assessment of key domains, such as depression, adherence, and substance use, and feasible interventions, we propose to evaluate this innovative way to improve clinical outcomes. Trial Registration: NCT01505660; (Archived by WebCite at http://www.webcitation/ 6ktOq6Xj7)

  • Doctor With Money-box. Image source: Author: George Hodan. License: Public Domain.

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


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

  • ENHANCE. Image sourced and copyright owned by authors.

    ENHANCE—(Electronic Hydroxyurea Adherence): A Protocol to Increase Hydroxyurea Adherence in Patients with Sickle Cell Disease


    Background: Hydroxyurea (HU) is the only disease-modifying medication for patients with sickle cell disease (SCD). HU can reduce SCD-related complications but only 35% to 50% of pediatric patients adhere to HU at the rates achieved in clinical trials and this limits its clinical effectiveness. Mobile Directly Observed Therapy (Mobile DOT) is a pilot-tested, electronic, multidimensional, HU adherence intervention that targets many components of the Health Behavior Model. Objective: The aim of this study is to evaluate the impact of Mobile DOT on HU adherence in children with SCD. The objective of our study is to inform the development of future adherence interventions and pediatric SCD protocols. Methods: This is a single-arm crossover study of pediatric patients with SCD. Participants self-record videos of their daily HU administrations and receive text message alerts to take HU, feedback on their HU adherence, and incentives when they achieve adherence goals during the 6-month Mobile DOT phase. Participants’ HU adherence during the Mobile DOT phase is compared with their baseline HU adherence (6 months prior to study entry) and to their HU adherence 6 months after completing the Mobile DOT phase. The primary outcome of this study is HU adherence measured by medication possession ratio. Results: The trial is ongoing. Preliminary review of participant satisfaction results suggest that most participants can complete Mobile DOT in less than 5 minutes per day and are satisfied with the intervention. Conclusions: If effective, the Mobile DOT strategy will increase HU adherence and this could improve patients’ clinical outcomes and reduce costs of care.

  • Source:, CC0 Public Domain.

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


    Background: Remote Australia is a complex environment characterized by workforce shortages, isolated practice, a large resident Indigenous population, high levels of health need, and limited access to services. In recent years, there has been an increasing trend of utilizing a short-term visiting (fly-in/fly-out) health workforce in many remote areas. However, there is a dearth of evidence relating to the impact of this transitory workforce on the existing resident workforce, consumer satisfaction, and the effectiveness of current services. Objective: This study aims to provide rigorous empirical data by addressing the following objectives: (1) to identify the impact of short-term health staff on the workload, professional satisfaction, and retention of resident health teams in remote areas; (2) to identify the impact of short-term health staff on the quality, safety, and continuity of patient care; and (3) to identify the impact of short-term health staff on service cost and effectiveness. Methods: Mixed methods will be used. Administrative data will be extracted that relates to all 54 remote clinics managed by the Northern Territory Department of Health, covering a population of 35,800. The study period will be 2010 to 2014. All 18 Aboriginal Community-Controlled Health Services in the Northern Territory will also be invited to participate. We will use these quantitative data to describe staffing stability and turnover in these communities, and then utilize multiple regression analyses to determine associations between the key independent variables of interest (resident staff turnover, stability or median survival, and socioeconomic status, community size, and per capita funding) and dependent variables related to patient care, service cost, quality, and effectiveness. The qualitative component of the study will involve in-depth interviews and focus groups with staff and patients, respectively, in six remote communities. Three communities will be high staff turnover communities and three characterized by low turnover. This will provide information on service quality, impact on resident and visiting staff, and patient satisfaction with the services. The research team will work with staff, patients, and a key stakeholder group of senior policymakers to develop workforce strategies to maintain or attain remote health workforce stability. Results: The study commenced in 2015. As of October 2016, fieldwork has been almost completed and quantitative analysis has commenced. Results are expected to be published in 2017. Conclusions: The study has commenced, but it is too early to provide results or conclusions.

  • Conference smartphone use. Image Source: Copyright: License: CC0 License.

    Evaluation of the Swedish Web-Version of Quality of Recovery (SwQoR): Secondary Step in the Development of a Mobile Phone App to Measure Postoperative Recovery


    Background: The majority of all surgeries are performed on an outpatient basis (day surgery). The Recovery Assessment by Phone Points (RAPP) app is an app for the Swedish Web-version of Quality of Recovery (SwQoR), developed to assess and follow-up on postoperative recovery after day surgery. Objectives: The objectives of this study are (1) to estimate the extent to which the paper and app versions of the SwQoR provide equivalent values; (2) to contribute evidence as to the feasibility and acceptability of a mobile phone Web-based app for measuring postoperative recovery after day surgery and enabling contact with a nurse; and (3) to contribute evidence as to the content validity of the SwQoR. Methods: Equivalence between the paper and app versions of the SwQoR was measured using a randomized crossover design, in which participants used both the paper and app version. Feasibility and acceptability was evaluated by a questionnaire containing 16 questions regarding the value of the app for follow-up care after day surgery. Content validity evaluation was based on responses by day surgery patients and the staff of the day surgery department. Results: A total of 69 participants completed the evaluation of equivalence between the paper and app versions of the SwQoR. The intraclass correlation coefficient (ICC) for the SwQoR was .89 (95% CI 0.83-0.93) and .13 to .90 for the items. Of the participants, 63 continued testing the app after discharge and completed the follow-up questionnaire. The median score was 69 (inter-quartile range, IQR 66-73), indicating a positive attitude toward using an app for follow-up after day surgery. A total of 18 patients and 12 staff members participated in the content validity evaluation. The item-level content validity index (I-CVI) for the staff group was in the 0.64 to 1.0 range, with a scale-level content validity index (S-CVI) of 0.88. For the patient group, I-CVI was in the range 0.30 to 0.92 and S-CVI was 0.67. The content validity evaluation of the SwQoR, together with three new items, led to a reduction from 34 to 24 items. Conclusions: Day surgery patients had positive attitudes toward using the app for follow-up after surgery, and stated a preference for using the app again if they were admitted for a future day surgery procedure. Equivalence between the app and paper version of the SwQoR was found, but at the item level, the ICC was less than .7 for 9 items. In the content validity evaluation of the SwQoR, staff found more items relevant than the patients, and no items found relevant by either staff or patients were excluded when revising the SwQoR.

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    Dementia and Traffic Accidents: A Danish Register-Based Cohort Study


    Background: As a consequence of a rapid growth of an ageing population, more people with dementia are expected on the roads. Little is known about whether these people are at increased risk of road traffic-related accidents. Objective: Our study aims to investigate the risk of road traffic-related accidents for people aged 65 years or older with a diagnosis of dementia in Denmark. Methods: We will conduct a nationwide population-based cohort study consisting of Danish people aged 65 or older living in Denmark as of January 1, 2008. The cohort is followed for 7 years (2008-2014). Individual’s personal data are available in Danish registers and can be linked using a unique personal identification number. A person is identified with dementia if the person meets at least one of the following criteria: (1) a diagnosis of the disease in the Danish National Patient Register or in the Danish Psychiatric Central Research Register, and/or (2) at least one dementia diagnosis-related drug prescription registration in the Danish National Prescription Registry. Police-, hospital-, and emergency room-reported road traffic-related accidents occurred within the study follow-up are defined as the study outcome. Cox proportional hazard regression models are used for the main analysis. Results: Our study protocol has 3 phases including data collection, data analysis, and reporting. The first phase of register-based data collection of 853,228 individual’s personal information was completed in August, 2016. The next phase is data analysis, which is expected to be finished before December 2016, and thereafter writing publications based on the findings. The study started in January 2016 and will end in December 2018. Discussion: This study covers the entire elderly population of Denmark, and thereby will avoid selection bias due to nonparticipation and loss to follow-up. Furthermore, this ensures that the study results are reliable and generalizable. However, underreporting of traffic-related accidents may occur, which will limit estimation of absolute risks.

  • Electronic blood sugar monitor. Copyright: Biswarup Ganguly. Image source: License: CC BY 3.0.

    Design and Usability Evaluation of Social Mobile Diabetes Management System in the Gulf Region


    Background: The prevalence of diabetes in the Gulf States is one of the highest globally. It is estimated that 20% of the population in the region has been diagnosed with diabetes and according to the International Diabetes Federation (IDF), five of the IDF’s “top 10” countries for diabetes prevalence in 2011 and projected for 2030 are in this region. In recent years, there have been an increasing number of clinical studies advocating the use of mobile phone technology for diabetes self-management with improved clinical outcomes. However, there are few studies to date addressing the application of mobile diabetes management in the Gulf region, particularly in the Kingdom of Saudi Arabia (KSA), where there is exponential increase in mobile phone usage and access to social networking. Objective: The objective of this paper is to present the design and development of a new mobile health system for social behavioral change and management tailored for Saudi patients with diabetes called Saudi Arabia Networking for Aiding Diabetes (SANAD). A usability study for the SANAD system is presented to validate the acceptability of using mobile technologies among patients with diabetes in the KSA and the Gulf region. Methods: The SANAD system was developed using mobile phone technology with diabetes management and social networking modules. For the usability study the Questionnaire for User Interaction Satisfaction was used to evaluate the usability aspect of the SANAD system. A total of 33 users with type 2 diabetes participated in the study. Results: The key modules of the SANAD system consist of (1) a mobile diabetes management module; (2) a social networking module; and (3) a cognitive behavioral therapy module for behavioral change issues. The preliminary results of the usability study indicated general acceptance of the patients in using the system with higher usability rating in patients with type 2 diabetes. Conclusions: We found that the acceptability of the system was high among Saudi patients with diabetes, and ongoing work in this research area is underway to conduct a clinical pilot study in the KSA for patients with type 2 diabetes. The wide deployment of such a system is timely and required in the Gulf region due to the wide use of mobile phones and social networking mediums.

  • World map. Image source: License: Creative Commons Attribution-Share Alike 3.0 Unported.

    Reliable Quantification of the Potential for Equations Based on Spot Urine Samples to Estimate Population Salt Intake: Protocol for a Systematic Review and...


    Background: Methods based on spot urine samples (a single sample at one time-point) have been identified as a possible alternative approach to 24-hour urine samples for determining mean population salt intake. Objective: The aim of this study is to identify a reliable method for estimating mean population salt intake from spot urine samples. This will be done by comparing the performance of existing equations against one other and against estimates derived from 24-hour urine samples. The effects of factors such as ethnicity, sex, age, body mass index, antihypertensive drug use, health status, and timing of spot urine collection will be explored. The capacity of spot urine samples to measure change in salt intake over time will also be determined. Finally, we aim to develop a novel equation (or equations) that performs better than existing equations to estimate mean population salt intake. Methods: A systematic review and meta-analysis of individual participant data will be conducted. A search has been conducted to identify human studies that report salt (or sodium) excretion based upon 24-hour urine samples and spot urine samples. There were no restrictions on language, study sample size, or characteristics of the study population. MEDLINE via OvidSP (1946-present), Premedline via OvidSP, EMBASE, Global Health via OvidSP (1910-present), and the Cochrane Library were searched, and two reviewers identified eligible studies. The authors of these studies will be invited to contribute data according to a standard format. Individual participant records will be compiled and a series of analyses will be completed to: (1) compare existing equations for estimating 24-hour salt intake from spot urine samples with 24-hour urine samples, and assess the degree of bias according to key demographic and clinical characteristics; (2) assess the reliability of using spot urine samples to measure population changes in salt intake overtime; and (3) develop a novel equation that performs better than existing equations to estimate mean population salt intake. Results: The search strategy identified 538 records; 100 records were obtained for review in full text and 73 have been confirmed as eligible. In addition, 68 abstracts were identified, some of which may contain data eligible for inclusion. Individual participant data will be requested from the authors of eligible studies. Conclusions: Many equations for estimating salt intake from spot urine samples have been developed and validated, although most have been studied in very specific settings. This meta-analysis of individual participant data will enable a much broader understanding of the capacity for spot urine samples to estimate population salt intake.

  • Image from GCO promotional campaign. Source and copyright: the authors.

    Get Checked… Where? The Development of a Comprehensive, Integrated Internet-Based Testing Program for Sexually Transmitted and Blood-Borne Infections in...


    Background: Testing for sexually transmitted and blood-borne infections (STBBI) is an effective public health strategy that can promote personal control of one’s health and prevent the spread of these infections. Multiple barriers deter access to testing including fear of stigmatization, inaccurate health care provider perceptions of risk, and reduced availability of clinic services and infrastructure. Concurrent increases in sexually transmitted infection (STI) rates and demands on existing clinical services make this an even more pressing concern. Web-based testing offers several advantages that may alleviate existing clinical pressures and facilitate appropriate testing access. Objective: This paper describes the planning, development, and usability testing of a novel Web-based testing service, GetCheckedOnline (GCO), as a complementary testing option integrated within existing sexual health services within British Columbia (BC). Methods: From 2009 to 2014, we engaged a multidisciplinary team in the design and development of GCO. We conducted 3 initial research studies to ascertain the opinions of youth, men who have sex with men (MSM), and STI clinic clients regarding Web-based testing and elicited perspectives of sexual health care providers through focus groups. We developed an informed consent process, risk assessment questions, and test recommendations based on provincial and national guidelines and evaluated these through consultations with clinical and community stakeholders. We also conducted a preliminary health equity impact assessment whose findings also informed the GCO program mode. Finally, from April 2011 to December 2012 we gathered qualitative data from 25 participants on the functionality and usability of a GCO prototype and incorporated their recommendations into a final model. Results: GCO launched in the fall of 2014 across 6 pilot sites in Vancouver, BC. The service involves 3 main steps: (1) create an account, complete an assessment, and print a laboratory requisition, (2) provide blood and urine specimens at participating laboratory locations, and (3) receive test results on the Internet or by phone. During this pilot phase, we promoted GCO to existing STI clinic clients and MSM in the Greater Vancouver region. A rigorous mixed-method evaluation of GCO’s uptake, acceptability, and health system impacts is currently underway. Conclusions: GCO is the first comprehensive Web-based STBBI testing program in Canada that is integrated with existing sexual health services, with the potential to reduce pressures on existing clinical services and reach populations facing the greatest barriers to testing. Our experience highlights the facilitators and challenges of developing and implementing novel complex eHealth interventions within the health care system, and underscores the importance of considering broader implementation contexts.

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  • Dance for adults with fibromyalgia, what do we know about it? Protocol for a scoping review

    Date Submitted: Oct 23, 2016

    Open Peer Review Period: Oct 23, 2016 - Nov 6, 2016

    Background: Fibromyalgia is a chronic disorder characterized by widespread muscular tenderness, pain, fatigue and cognitive difficulties. Non-pharmacological treatment options, such as physical activi...

    Background: Fibromyalgia is a chronic disorder characterized by widespread muscular tenderness, pain, fatigue and cognitive difficulties. Non-pharmacological treatment options, such as physical activity, are important for people with fibromyalgia. There are strong recommendations to support engagement in physical activity for symptom management among adults with fibromyalgia. Dance is a mode of physical activity that may allow individuals with fibromyalgia to improve their physical function, health, and well-being. Dance has the potential to promote improved pain processing while simultaneously providing the health and social benefits of engaging in physical activity that contribute to symptom management. However, we are unaware of current evidence on dance as a non-pharmacological/physical activity intervention for adults with fibromyalgia. Objective: the aims of the study are to provide an overview of the extant evidence to understand how dance is used for individuals with fibromyalgia; to examine the extent, range and nature of research activity in the area; and to determine the value of undertaking a full systematic review. Methods: Scoping reviews are useful to comprehensively and systematically map the literature and identify key evidence, or research gaps. The search strategy will involve electronic databases including: Medline; EMBASE, CENTRAL, PsycInfo, CINAHL, LILACS, AMED, International Bibliography of Theatre and Dance, PEDro, Trip, Proquest Theses/Dissertations, Web of Science, WHO International Clinical Trials Registry Platform, and In designing the protocol, the study will be mapped in seven stages: 1) identifying the research questions, 2) identifying relevant studies, 3) study selection, 4) charting the data, 5) collating, summarising and reporting the results, 6) consultation, and 7) knowledge dissemination. Results: A large body of evidence from the past decades supports the use of exercise as one of the main non-pharmacological interventions for individuals with fibromyalgia. Conclusions: To our knowledge this will be the first attempt to systematically identify knowledge of dance as a potential intervention for adults with fibromyalgia. This scoping review offers a feasible means for describing the evidence specific to dance and fibromyalgia: results will provide unique insights concerning the breadth and depth of literature in the area. An analysis of this body of literature as a whole may reveal new research directions or unknown ways this intervention could strengthen current management approaches of the disease.

  • The servi-Share protocol: co-creating and evaluating a web-application mapping real-world healthcare services for students

    Date Submitted: Oct 19, 2016

    Open Peer Review Period: Oct 19, 2016 - Nov 2, 2016

    Background: University students aged 18-30 years are a population group reporting low access to healthcare services with high rates of avoidance and delay of medical care. However they are at risk for...

    Background: University students aged 18-30 years are a population group reporting low access to healthcare services with high rates of avoidance and delay of medical care. However they are at risk for several health problems, and regular medical consultations are recommended in this period of life. University students report not having appropriate information on recommended medical care and services. New digital devices are popular among the young and web-applications can be used to facilitate easy access to this type of information. A few eHealth tools have been developed with the purpose of showing real-world healthcare services and little is known on how such eHealth tools can improve access to care. Objective: This paper describes the processes of co-creating and evaluating the beta version of a web-application aimed at mapping and describing free or low-cost real-world healthcare services available in the Bordeaux area (France) and specifically addressed to university students. Methods: The co-creating process involve: (a) exploring the need of students to know and access real-world healthcare services; (b) identifying the real-world healthcare services of interest for students; and (c) deciding on user interface, and developing the beta version of the web-application. Finally, the evaluating process involve: (a) testing the beta version of the web-application with target audience (university students aged 18-30 years); (b) collecting their feedback through a satisfaction survey; and (c) planning a long-term evaluation. Results: The co-creation process of the beta version of the web-application was completed in August 2016 and is described in this manuscript. The evaluation process was started on September 7, 2016. We anticipate completing the project by December 2016. Conclusions: Web-applications are an innovative way to increase the health literacy of the young in terms of delivery of and access to care. The creation of web-applications must involve stakeholders, i.e. students and healthcare providers, for correctly identifying the real-world healthcare services to be displayed. Clinical Trial: Not applicable

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    Date Submitted: Oct 17, 2016

    Open Peer Review Period: Oct 17, 2016 - Oct 31, 2016

    Background: Migration has an impact on the epidemiology of viral Hepatitis (HEP) and HIV in Germany, and migrants from sub-Saharan Africa (MisSA) in Germany are disproportionally affected by HIV. In t...

    Background: Migration has an impact on the epidemiology of viral Hepatitis (HEP) and HIV in Germany, and migrants from sub-Saharan Africa (MisSA) in Germany are disproportionally affected by HIV. In the last 10 years a total of 10-15% of all newly diagnosed HIV-cases are MisSA, and 20-30% of them acquired HIV in Germany. Prevalence of HEP among MisSA in Germany is unknown, but Western Africa, where most MisSA in Germany originate from, reports the highest prevalence of hepatitis B worldwide. There is limited information on knowledge, attitudes, behaviors and practices (KABP) regarding HIV, HEP and sexually transmitted infections (STI), as MisSA are not reached with surveys targeting the general population. Objective: We initiated a multi-center KABP to determine HIV, HEP and STI-information and -prevention needs of MisSA in Germany. Methods: This is a multicenter cross-sectional KABP-survey regarding HIV, HEP and STI among MisSA living in Germany using convenience sampling. The study design was developed as a community-based participatory health research (CBPHR) project: HIV/STI-prevention specialists, key-persons from MisSA-communities and HIV/STI-researchers are involved in all steps of the research process. Trained peer researchers recruit participants in six study cities. Potential modes of survey administration are interview or self-completion, and questionnaire is available in English, French and German. Questions on knowledge about HIV, HEP and STI are presented as true statements; participants are asked if they had known information before. Focus groups with MisSA are conducted to interpret results. Data collection is taking place from October 2014 to November 2016. Results: Data collection is ongoing. Recruitment by peer researchers is concluded and we reached 3,040 eligible participants. We are currently analyzing the quantitative data and collecting qualitative data in focus groups and working group meetings to discuss the results in the respective study cities and to evaluate the application of participatory health research in epidemiological studies. We expect to present results by the beginning of 2017. Conclusions: We chose working with peer researchers for data collection to get access to a diverse sample of MisSA and reach particularly vulnerable sub-groups, such as MisSA without legal status. Being able to access hard-to-be-reached is one of the big advantages of CBPHR. The active inclusion of the persons under study results in higher acceptance of the research project in the target community and ultimately leads to better quality of collected data. Furthermore, the participation of MisSA in the development of study design and data collection assures a better understanding of the interests, needs and living conditions of this group.

  • Effectiveness of a 16-weeks multimodal exercise program in individuals with dementia: a multi-centre, group randomized controlled trial (Study Protocol)

    Date Submitted: Oct 13, 2016

    Open Peer Review Period: Oct 13, 2016 - Oct 27, 2016

    Background: The increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affect...

    Background: The increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affects motor and cognitive skills in individuals with dementia (IWD). However, there is insufficient evidence probably related to several methodological limitations. Moreover, to date adequate physical activity interventions specifically developed for IWD are lacking. Objective: This study aims to investigate the effectiveness of a multimodal exercise program (MEP) on motor and cognitive skills in IWD in a high quality multi-centre trial. Methods: A multi-centre group randomized controlled trial with baseline and post assessments will be performed. It is planned to enrol 405 participants with dementia of mild to moderate stage, aged 65 years and older. The intervention group will participate in a 16-weeks ritualized MEP especially developed for IWD. The effectiveness of the MEP on primary outcomes balance, mobility, and gait will be examined using a comprehensive test battery. Secondary outcomes are strength and function of lower limb, activities of daily living, and cognition (overall cognition, language, processing speed, learning and memory, visual spatial cognition). Results: Enrolment for the study started in May 2015. It is planned to complete post assessments by the beginning of 2017. Results are expected to be available in the first half of 2017. Conclusions: This study will contribute in enhancing evidence for the effects of physical activity on motor and cognitive skills in IWD. Compared to previous studies, this study is characterised by a dementia specific intervention based on scientific knowledge, a combination of motor and cognitive tasks in the intervention, and high standards regarding methodology. Findings are highly relevant for IWD suffering from multiple motor and cognitive impairments and often participating in limited physical activity. Clinical Trial: DRKS00010538 (German Clinical Trial Register, date of registration: 01 June 2016, retrospectively registered).

  • Negotiation of sexual consent among unmarried adolescents and young adults: A systematic scoping review protocol

    Date Submitted: Oct 11, 2016

    Open Peer Review Period: Oct 11, 2016 - Oct 25, 2016

    Background: Introduction: Sexual assault/violence is a global public health problem. In recent years most preventive educational programs targeting the youth are focusing more on promoting understandi...

    Background: Introduction: Sexual assault/violence is a global public health problem. In recent years most preventive educational programs targeting the youth are focusing more on promoting understanding and communication of sexual consent so as to reduce incidence of sexual assaults. Explicit understanding of communication and interpretation of sexual consent among unmarried adolescents and young adults is needed to strengthen such programs. The aim of this study is to map evidence on communication of sexual consent among unmarried adolescents and young adults in order to explore how they negotiate sexual consent in non-coercive situations. Methods and Analysis: The literature search will be performed using the following databases: CINAHL, PubMed, Google Scholar, and EBSCOhost (Medline, PsycINFO, PsycArticles, Health Source: Nursing/Academic Edition, Health Source – Complete, Academic Search Complete). Grey literature will be searched using relevant websites such as Google search and World Health Organization ( based on inclusion criteria. Study titles, abstracts and full articles of each study will be screened for eligibility. Eligible studies will undergo data extraction. The Mixed Methods Appraisal Tool (MMAT) – Version 2011 will be used for quality appraisal of included studies. A thematic analysis will be carried out collectively by the research team to extract outcomes of interest. Discussion: It is anticipated that this review will shed light on how adolescents and young adults communicate and their interpretation of consent to sex. The findings of this study may guide future research and inform sexual assault prevention programs and policies. Dissemination: The study will be disseminated through publication and conferences presentation. PROSPERO registration number: CRD4201604843 Objective: The research team propose a scoping review of evidence from literature to understand how adolescents and young adults understand, communicate and interpret sexual consent as well as non-consent. The study questions are as follows: • How do unmarried adolescents and young adults understand sexual consent in relationships? • What verbal and non-verbal ways do they use to communicate sexual consent or non-consent to sexual activity in non-coercive situations? • How do young people interpret sexual consent or non-consent in non-coercive situations? Methods: Database: The search will be conducted using the CINAHL, PubMed, Google Scholar, and EBSCOhost (Medline, PsycINFO, PsycArticles, Health Source: Nursing/Academic Edition, Health Source – Complete, Academic Search Complete) literature databases. The researchers will search the listed literature database from January 1996 to October 2016. Search terms will include: ‘sexual consent’, ‘conceptualization of sexual consent’ ‘sexual consent behaviours’ ‘non-consent behaviours’ ‘sexual consent/non-consent and college’ ‘perception of sexual consent/non-consent’ ‘consent to sexual activity’ ‘sexual consent/non-consent and homosexual relationship’ ‘sexual consent/non-consent in heterosexual relationship’. Within each search string possible relevant searches will be combined using ‘OR’ (‘sexual consent or non-consent’). Separate search strings will be combined using AND (i.e ‘sexual consent/non-consent’ and ‘adolescents’ etc.). We will search the grey literature using the relevant websites such as Google search and World Health Organization ( Using citation indexing in Web of Knowledge and citations facility in MEDLINE, we will embark on thorough reference-checking of relevant papers looking articles that cite our target papers. Electronic search will be recorded independently under the following heading: Date; keyword searched; database used and number of articles retrieved. Study inclusion and exclusion criteria Articles will be selected based on the inclusion and exclusion criteria as follow: Inclusion criteria: • Papers published since January 1996 to September 2016. • Evidences published in English languages. • Studies reporting on how a homosexual or/and bisexual or/and heterosexual adolescent and young adults communicate and interpret consent or non-consent/refusal. • Papers reporting on how adolescents and young adults interpret their partners’ sexual consent and/or non-consent. • Review articles will include: peer-reviewed journal articles, systematic reviews, scoping reviews and rapid reviews. • Grey literature will include: government and non-governmental organization reports and academic dissertations. • Full reports of studies to be considered include: mixed methods, quantitative and qualitative studies. • All Study designs such qualitative, quantitative, mixed methods studies etc. will be considered. Exclusion criteria: • Evidence published before the year 1996. • Evidence not published in English language. • No full journal article available. • Studies carried out how married people consent or non-consent to sexual activity. • Studies analyzing sexual consent as defined by government policies. • Studies and papers reporting on communication of sexual consent or refusal in coercive situations. Study Selection A two-step process will be used for study screening. Titles and abstracts (when available) will be screened independently by two reviewers against the inclusion criteria, if necessary a third reviewer will be consulted to resolve any discrepancy. Reasons for excluded studies will be stated.[18] Then the eligible articles/papers will undergo a full text screening for data extraction (see figure 1). Results: Collating, Summarizing and reporting results Details regarding publication information [paper title, main author, journal and publication year; study design and setting (if relevant); target population and sampling (if relevant) and main findings] along with any additional informational pertinent to the overall scoping question will be recorded independently by each reviewer for all of the sources. The recorded information will be discussed and agreed on, so as to gain an overall perspective on the themes emerging from the literature addressing the scoping questions. The results of the study on behaviors and words that indicating sexual consent or refusal as well as behaviors and words interpreted as sexual consent or refusal will be coded independently by all each researcher. Afterward, the research team will meet to cross-examine the relationship between the emerging themes and the research questions. Finally, the study findings will then be discussed in relation to gaps in knowledge for future research, practice and policy. Conclusions: Conclusions This review will highlight how adolescents and young adults understand, communicate and interpret sexual consent as well as non-consent. It will serve as a basis for further research on this area. Clinical Trial: Not Applicable

  • Bioengineered disc implants in temporomandibular joint (TMJ): study protocol for a two phase exploratory randomized preclinical pilot trial in 18 Black Merino Sheep (TEMPOJIMS)

    Date Submitted: Oct 10, 2016

    Open Peer Review Period: Oct 10, 2016 - Oct 24, 2016

    Background: Preclinical trials are essential to test efficacious options to substitute the temporomandibular joint (TMJ) disc. The contemporary absence of ideal treatment for patients can be related w...

    Background: Preclinical trials are essential to test efficacious options to substitute the temporomandibular joint (TMJ) disc. The contemporary absence of ideal treatment for patients can be related with difficulties concerning the appropriate study design to conduct preclinical trials in TMJ field. These difficulties can be related to the use of heterogeneous animal models, the use of contralateral TMJ as control, the absence of randomized controlled pre clinical trials with blinding outcomes assessors and difficulties to involve multidisciplinary teams. Objective: This study aims to provide rigorous data by addressing the following objectives: (1) to identify the impact of bilateral discectomy in Black Merino Sheep (BMS); (2) to identify the impact of bilateral discopexy in BMS; (3) to identify the impact of 3 different bioengineering TMJ discs in BMS. Methods: A two phases exploratory randomized preclinical trial with blinded outcomes is proposed. In the first phase, 9 sheep are randomized in 3 different surgical bilateral procedures: discectomy, discopexy and sham surgery. In the second phase, 9 sheep are randomized to test 3 different TMJ discs implants. The primary outcome is the histological gradation of TMJ. Secondary outcomes are: radiological changes, absolute masticatory time, rate masticatory time/masticatory cycle, masticatory kinetics, masticatory area and sheep weight. Results: Previous preclinical studies in this field have used the contralateral unoperated side as a control, different animal models ranging from mice to canine model with non randomized and non blinded designs. The main goal of this exploratory preclinical protocol is to set a new standard for future preclinical trials in oromaxilofacial surgery, more particularly in TMJ field proposing a rigorous design in Black Merino Sheep. The authors also intend to test the feasibility of pilot outcomes. The authors expect to increase the quality of further studies in this field and to help in future treatment of patients undergoing surgery for TMJ disc replacement. Conclusions: The study has commenced, but it is too early to provide results or conclusions. Clinical Trial: The present study is approved by the Portuguese National Authority for Animal Health.