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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 2016: 5.175)

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:

  • St. Olav's University Hospital. Source: The Authors; Copyright: Halvor Langeland; URL:; License: Creative Commons Attribution (CC-BY).

    Transitions Between Circulatory States After Out-of-Hospital Cardiac Arrest: Protocol for an Observational, Prospective Cohort Study


    Background: The post cardiac arrest syndrome (PCAS) is responsible for the majority of in-hospital deaths following cardiac arrest (CA). The major elements of PCAS are anoxic brain injury and circulatory failure. Objective: This study aimed to investigate the clinical characteristics of circulatory failure and inflammatory responses after out-of-hospital cardiac arrest (OHCA) and to identify patterns of circulatory and inflammatory responses, which may predict circulatory deterioration in PCAS. Methods: This study is a single-center cohort study of 50 patients who receive intensive care after OHCA. The patients are followed for 5 days where detailed information from circulatory variables, including measurements by pulmonary artery catheters (PACs), is obtained in high resolution. Blood samples for inflammatory and endothelial biomarkers are taken at inclusion and thereafter daily. Every 10 min, the patients will be assessed and categorized in one of three circulatory categories. These categories are based on mean arterial pressure; heart rate; serum lactate concentrations; superior vena cava oxygen saturation; and need for fluid, vasoactive medications, and other interventions. We will analyze predictors of circulatory failure and their relation to inflammatory biomarkers. Results: Patient inclusion started in January 2016. Conclusions: This study will obtain advanced hemodynamic data with high resolution during the acute phase of PCAS and will analyze the details in circulatory state transitions related to circulatory failure. We aim to identify early predictors of circulatory deterioration and favorable outcome after CA. Trial Registration: NCT02648061; (Archived by WebCite at

  • Source: Pixabay; Copyright: oswaldoruiz; URL:; License: Public Domain (CC0).

    Comparing Short Dental Implants to Standard Dental Implants: Protocol for a Systematic Review


    Background: Short dental implants have been proposed as a simpler, cheaper, and faster alternative for the rehabilitation of atrophic edentulous areas to avoid the disadvantages of surgical techniques for increasing bone volume. Objective: This review will compare short implants (4 to 8 mm) to standard implants (larger than 8 mm) in edentulous jaws, evaluating on the basis of marginal bone loss (MBL), survival rate, complications, and prosthesis failure. Methods: We will electronically search for randomized controlled trials comparing short dental implants to standard dental implants in the following databases: PubMed, Web of Science, EMBASE, Scopus, the Cochrane Central Register of Controlled Trials, and with English language restrictions. We will manually search the reference lists of relevant reviews and the included articles in this review. The following journals will also be searched: European Journal of Oral Implantology, Clinical Oral Implants Research, and Clinical Implant Dentistry and Related Research. Two reviewers will independently perform the study selection, data extraction and quality assessment (using the Cochrane Collaboration tool) of included studies. All meta-analysis procedures including appropriate effect size combination, sub-group analysis, meta-regression, assessing publication or reporting bias will be performed using Stata (Statacorp, TEXAS) version 12.1. Results: Short implant effectiveness will be assessed using the mean difference of MBL in terms of weighted mean difference (WMD) and standardized mean difference (SMD) using Cohen’s method. The combined effect size measures in addition to the related 95% confidence intervals will be estimated by a fixed effect model. The heterogeneity of the related effect size will be assessed using a Q Cochrane test and I2 measure. The MBL will be presented by a standardized mean difference with a 95% confidence interval. The survival rate of implants, prostheses failures, and complications will be reported using a risk ratio at 95% confidence interval (P<.05). Conclusions: The present protocol illustrates an appropriate method to perform the systematic review and ensures transparency for the completed review. The results will be published in a peer-reviewed journal and social networks. In addition, an ethics approval is not considered necessary. Trial Registration: PROSPERO registration number: CRD42016048363; display_record.asp?ID=CRD42016048363 (Archived by WebCite at

  • Testing procedures during the sensory laboratory paradigm inside a dim-lit room. Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    The Role of Ethnicity and Environment in the Regulation of Response to Sensory Stimulus in Children: Protocol and Pilot Findings of a Neurophysiological Study


    Background: The ability to regulate the response to sensory stimuli has been associated with successful behavioral patterns necessary for daily activities. However, it is not known whether a child’s ethnicity and environment can influence autonomic regulatory mechanisms. Objective: This study aims to explore the role of ethnicity and environment in the regulation of responses to sensory stimuli in children. Methods: In this study, we intend to recruit 128 children from different ethnic groups or environment contexts as follows: (1) 32 typically developing Chinese children living in Hong Kong; (2) 32 typically developing Filipino children living in Hong Kong; (3) 32 typically developing Filipino children who are living in urban areas; and (4) 32 typically developing Filipino children who are living in rural areas in Philippines. Autonomic activity (heart rate variability [HRV] and electrodermal activity [EDA]) will be measured and recorded using Polar H2 heart rate monitor and eSense GSR skin response sensor. Autonomic activity (HRV-low frequency, HRV-high frequency, and EDA) at different conditions between pairwise groupings will be tested using multivariate analysis of variance (MANOVA). All significant levels will be set at P ≤.05. Results: We present the research protocol of this study, as well as a short discussion of the preliminary findings from our pilot data, with consequent power and sample size analysis that informs the appropriate sample needed to test our hypothesis. Conclusions: This study will increase the understanding on the role of individual differences related to a child’s ethnicity and environment in the regulation of response to sensory stimuli. The findings of this research may further shed light on the evaluation and treatment planning for children across and within cultures.

  • Source: Netherlands Ski Federation; Copyright: Netherlands Ski Federation; URL:; License: Licensed by the authors.

    A Tailored Web-based Advice Tool for Skiers and Snowboarders: Protocol for a Randomized Controlled Trial


    Background: Being active in sports has many positive health effects. The direct effects of engaging in regular physical activity are particularly apparent in the prevention of several chronic diseases, including cardiovascular disease, diabetes, cancer, hypertension, obesity, depression, and osteoporosis. Besides the beneficial health effects of being active, sports participation is unfortunately also associated with a risk of injuries. In the case of many sports injuries (eg, winter sports) preventive measures are not compulsory, which means that a behavioral change in sports participants is necessary to increase the use of effective measures, and subsequently prevent or reduce injuries in sports. Objective: The evidence-based Wintersportklaar online intervention has been developed to stimulate injury preventive behavior among skiers and snowboarders. In this article, the design of the effectiveness study will be described. Methods: A randomized controlled trial with a follow-up period of four months during the winter sport season will be conducted. The participants consist of inexperienced skiers and snowboarders. At baseline, skiers and snowboarders in the intervention and control groups are asked to report the injury preventive measures they usually take during their preparation for their winter sport holiday. One and three months after baseline, skiers and snowboarders are asked to report retrospectively in detail what measures they took regarding injury prevention during their current winter sport preparation and winter sport holiday. Descriptive analyses (mean, standard deviation, frequency, range) are conducted for the different baseline variables in both study groups. To evaluate the success of the randomization, baseline values are analyzed for differences between the intervention and control groups (chi square, independent T tests and/or Mann-Whitney test). Chi square tests and/or logistic regression analyses are used to analyze behavioral change according to the intention to treat principle (as initially assigned). Results: The project was funded in 2016 and enrolment was completed in 2017. Data analysis is currently under way and the first results are expected to be submitted for publication in 2018. Conclusions: To combat the negative side effects of sports participation, the use of injury preventive measures is desirable. As the use of injury prevention is usually not compulsory in skiing and snowboarding, a behavioral change is necessary to increase the use of effective injury preventive measures in winter sports. Trial Registration: Dutch Trial Registry NTR6233; (Archived by WebCite at

  • Source:; Copyright: StockSnap; URL:; License: Public Domain (CC0).

    Effects of Psychiatric Comorbidity in Immune-Mediated Inflammatory Disease: Protocol for a Prospective Study


    Background: Immune-mediated inflammatory diseases (IMID), such as inflammatory bowel disease (IBD), multiple sclerosis (MS), and rheumatoid arthritis (RA), are highly prevalent in Canada and the United States and result in substantial personal and societal burden. The prevalence of psychiatric comorbidities, primarily depression and anxiety, in IMID exceeds those in the general population by two- to threefold, but remains underdiagnosed and undertreated. Furthermore, the effects of psychiatric comorbidity on IMID are not well understood. Objective: The objectives of this study were (1) to compare health-related quality of life and work ability in persons with IMID and psychiatric comorbidity with those of persons with IMID without psychiatric comorbidity and with those of persons with depression and anxiety disorders alone, and (2) to validate existing case identification tools for depression and anxiety in persons with IMID to facilitate improved identification of depression and anxiety by clinicians. To achieve these objectives, we designed a prospective 3-year longitudinal study. In this paper, we aim to describe the study rationale and design and the characteristics of study participants. Methods: Between November 2014 and July 2016, we recruited 982 individuals from multiple clinic and community sources; 18 were withdrawn due to protocol violations. Results: The final study sample included 247 participants with IBD, 255 with MS, 154 with RA, and 308 with depression or anxiety. The majority were white, with the proportion ranging from 85.4% (IBD [210/246]; MS [217/254]) to 74.5% (114/153, RA; P=.01). There was a female predominance in all groups, which was highest in the RA cohort (84.4%, 130/154) and least marked in the IBD cohort (62.7%, 155/247). Participants with depression or anxiety were more likely to be single (36.0%, 111/308) than participants in any other group (11.8% [30/255]-22.7% [56/247], P<.001). Conclusions: This paper presents the rationale for this study, describes study procedures, and characterizes the cohort enrolled. Ultimately, the aim is improved care for individuals affected by IMID.

  • MEMPHIS study logo. Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial


    Background: Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app. Objective: To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app. Methods: Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance. Results: Recruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26, 2017. Conclusions: This feasibility trial will inform the design of a large multicentered trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP. Trial Registration: NCT02721108; (Archived by WebCite at; BioMed Central: ISRCTN10925965; (Archived by WebCite at

  • Photo of mMom project poster. Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

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


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

  • Source: Flickr; Copyright: LawPrieR; URL:; License: Creative Commons Attribution (CC-BY).

    A Shared Decision-Making Tool to Prevent Substance Abuse: Protocol for a Randomized Controlled Trial


    Background: Substance use disorder (SUD) affects over 20 million adults and costs over $700 billion annually in the United States. It is one the greatest health care challenges we face. Objective: This research project seeks to enhance the standard practice of Screening, Brief Intervention, and Referral to Treatment (SBIRT) through a mobile solution easily incorporated into primary care that will promote shared decision making and increase referral and adherence to specialty care through continued follow-up care. Methods: This research will conduct an Office of Management and Budget (OMB)–approved randomized controlled trial (RCT) in primary care and SUD specialty service providers. The RCT will recruit a total of 500 SUD patients. Recruited patients will be randomized into control and intervention arms. Both arms will take initial baseline and exit (30 days) surveys to evaluate self-reported substance use and specialty service utilization. The control arm patients will receive usual care. The intervention group patients will receive technology-enhanced SBIRT and a mobile follow-up program to track goals and substance use at home. The RCT tracks participants for 30 days after the primary care encounter. We will collect feedback from the patients during the 30 days and count the number of patients who use specialty care services in specialty care programs for tobacco, alcohol, and drug abuse (both from self-reporting and from the service providers). Results: RCT and data collection are underway. We expect to report the data results in 2018. Conclusions: We expect that significantly more intervention group patients will receive specialty SUD care within 30 days following the SBIRT encounter at the primary care clinic compared to the control group. We also expect that the intervention group patients will report a greater reduction in substance use and a greater drop in Drug Abuse Screening Test and Addition Severity Index scores within 30 days.

  • Source: The Authors/ Smartmockups; Copyright: JMIR Publications; URL:; License: Creative Commons Attribution (CC-BY).

    Effectiveness of a Technology-Based Supportive Educational Parenting Program on Parental Outcomes in Singapore: Protocol for a Randomized Controlled Trial


    Background: Supportive educational programs during the perinatal period are scarce in Singapore. There is no continuity of care available in terms of support from community care nurses in Singapore. Parents are left on their own most of the time, which results in a stressful transition to parenthood. There is a need for easily accessible technology-based educational programs that can support parents during this crucial perinatal period. Objective: The aim of this study was to describe the study protocol of a randomized controlled trial on a technology-based supportive educational parenting program. Methods: A randomized controlled two-group pretest and repeated posttest experimental design will be used. The study will recruit 118 parents (59 couples) from the antenatal clinics of a tertiary public hospital in Singapore. Eligible parents will be randomly allocated to receive either the supportive educational parenting program or routine perinatal care from the hospital. Outcome measures include parenting self-efficacy, parental bonding, postnatal depression, social support, parenting satisfaction, and cost evaluation. Data will be collected at the antenatal period, immediate postnatal period, and at 1 month and 3 months post childbirth. Results: Recruitment of the study participants commenced in December 2016 and is still ongoing. Data collection is projected to finish within 12 months, by December 2017. Conclusions: This study will identify a potentially clinically useful, effective, and cost-effective supportive educational parenting program to improve parental self-efficacy and bonding in newborn care, which will then improve parents’ social support–seeking behaviors, emotional well-being, and satisfaction with parenting. It is hoped that better supported and satisfied parents will consider having more children, which may in turn influence Singapore’s ailing birth rate. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 48536064; (Archived by WebCite at

  • Logo of the VIE program. Source: Cristelle Sinnett and Lokita Naki; Copyright: The Authors; License: Creative Commons Attribution (CC-BY).

    Research- and Practice-Based Nutrition Education and Cooking Workshops in Pediatric Oncology: Protocol for Implementation and Development of Curriculum


    Background: Progresses in childhood cancer treatment, diagnosis, and management have resulted in childhood cancer survival rates of over 80%. However, this therapeutic success comes with a heavy price: two-thirds of childhood cancer survivors will be affected by further complications, including cardiovascular and metabolic diseases. Adequate nutrition during cancer treatment is essential to ensure the child’s optimal development, improve tolerance to treatments, and can contribute to lower the risk of developing cardiometabolic diseases. Side effects of cancer treatments can negatively impact children’s nutritional intake and eating behaviors. Involving the families of childhood cancer patients in educational workshops could be a promising avenue to promote healthy eating during and after cancer treatment. Objective: The objectives of this study were to develop, validate, and implement a family-based nutrition education and cooking workshop curriculum in a pediatric oncology setting that addresses the nutritional issues encountered during treatments while promoting the adoption of healthy eating habits for the prevention of long-term cardiometabolic effects. Methods: The workshops were developed and validated following an 8-step iterative process, including a review of the literature and consultations with a steering committee. An evaluation tool was also developed. A nonrandomized study protocol was elaborated to implement the workshops and measure their impact. The themes of the 6 research- and practice-based lessons are as follows: meal fortification during cancer treatment, changes in taste during cancer therapy and their impact on children, adapting diet to eating-related side effects of treatments, nutritional support during cancer treatment, Mediterranean diet and health, and planning quick and economic meals. The validation process included consultations with the institution’s clinical nutrition professionals. Self-administered post questionnaires were developed according to the content of each workshop to measure short-term outcomes, namely, participants’ perception of knowledge acquisition, behavioral intention, and satisfaction. Medium-term outcomes that will be evaluated are participants’ anthropometric profile, quality of the diet, and circulating biomarkers of metabolic health. Results: The project was funded in 2016 and enrollment will be completed in 2021. Data analysis is currently under way and the first results are expected to be submitted for publication in 2019. Conclusions: This research- and practice-based nutrition education and cooking demonstration curriculum could be a valuable complement to a multidisciplinary lifestyle intervention for the prevention of long-term cardiometabolic complications in childhood cancer.

  • Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    Using Social Media for the Promotion of Education and Consultation in Adolescents Who Have Undergone Kidney Transplant: Protocol for a Randomized Control Trial


    Background: Falling ill represents a traumatic experience especially in adolescence, since in addition to the moments of ambiguity and contradictions that this period brings, there is coping with the disease. Renal transplantation provides a better quality of life but the dependence on dialysis is replaced by the greater responsibility of self-care. With advances in technology, contemporary communication methods are a strategic mechanism for the approximation of the adolescent and the multiprofessional team. In this perspective, our research may provide possible changes and propose alternatives, using social networks for the integration of the multiprofessional team, promoting education within a virtual environment for adolescents who have undergone kidney transplants. Objective: The goal of our research is to compare the knowledge, satisfaction, and self-esteem of adolescent renal transplant patients in 2 groups: patients undergoing conventional treatment versus patients undergoing conventional treatment plus the full-time use of social networks to aid in education and consultation. Methods: Nonblind randomized clinical trial with 128 adolescents (aged 13 to 21 years) divided in 2 groups: the first group will receive conventional care and the second group will be invited to participate in a secret group on the social network Facebook. This group will be used as a new education platform to involve young renal transplant patients to participate in the guidelines provided to them by the multiprofessional team. Results: An environment for learning and exchanging life experiences will be created by using a well-known technology among adolescents. As a low-cost intervention, it will allow a better interaction between the patient and the transplant team. It is expected that the adolescents will improve their knowledge about the disease also increasing their self-esteem and the treatment adhesion. Conclusions: Health professionals need to seek alternatives when educating patients, focusing on easily understandable ways for effective guidance. In the adolescent population, it is understood that the use of technology as support in education is a fundamental tool for this age group. The proposed project will directly benefit adolescent renal transplant patients as it uses language aimed directly at the target demographic. It attempts to overcome the traditional model by being more in contact with the current generation. This approach makes the content easier to assimilate and, consequently, increases understanding. Trial Registration: NCT03214965; (Archived by Webcite at

  • Source: Pixabay; Copyright: Astryd_MAD; URL:; License: Public Domain (CC0).

    Feasibility and Preliminary Effectiveness of the Homework Intervention Strategy (eHIS) Program to Enhance Male Condom Use: Research Protocol


    Background: Although condoms are effective in reducing the risk of sexually transmitted infections (STIs) and unintended pregnancy, they are still often not used consistently and correctly. Negative impact on sensation and pleasure, ruining the mood, causing problems with maintaining erection, and condom slippage or breakage are some of the reasons given by men explaining why they do not want to use condoms. Although many interventions promoting condom use exist, some of them delivered online are complex and time- and resource-intensive. The Homework Intervention Strategy (eHIS) program, adapted from the existing face-to-face Kinsey Institute Homework Intervention Strategy (KIHIS) program, aims to address these issues by encouraging men to focus on sensation and pleasure when trying different types of condoms and lubricants in a low-pressure situation (on their own, without a partner present). Objective: The objectives of this study are to assess the feasibility, acceptability, and users’ engagement with the eHIS program, its preliminary effectiveness in increasing condom use frequency and consistency, as well as the feasibility of the program's evaluation approach, including choice of measures and participant recruitment and retaining strategies (primary outcomes). Secondary outcomes include condom use experience, condom use attitudes, condom use self-efficacy, condom use errors and problems, and condom fit-and-feel. All of these will be analyzed in the context of participants’ demographics, sexual history, and previous condom use. Methods: The study has a pre-post-test, within-subjects design. Men aged 18 to 69 and living in the United Kingdom are recruited through posters, leaflets, social media, and emails. Study participants are asked to complete T1 (baseline) measures before entering the eHIS website. After completing the T1 measures, they can order a free condoms and lubricants kit and have access to the eHIS website for 4 weeks. During that time they are asked to practice using different types of condoms and lubricants on their own in a no-pressure situation. Following T1, participants are asked to complete the T2 and T3 measures at 4 and 10 weeks, respectively. Results: Data collection for the study is completed. Data analysis is in progress and is expected to be completed by February 2018. Conclusions: This brief, home-based, self-guided program may lead to increased consistent and correct condom use. Online delivery can make the program an easily accessible and low-cost health promotion intervention, which has the potential to reach a wide and diverse audience. If results of the current study show the program’s feasibility and preliminary effectiveness in changing condom use related outcomes, a larger scale randomized controlled trial (RCT) will be conducted. Trial Registration: Research Registry: researchregistry2325; home/registrationdetails/58da6cad1d7ab0314337d076/ (Archived by WebCite at

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  • Towards increasing engagement in substance use data collection: Development of the SARA app and protocol for a micro-randomized trial with adolescents and emerging adults

    Date Submitted: Jan 23, 2018

    Open Peer Review Period: Jan 23, 2018 - Feb 6, 2018

    Background: Substance use is an alarming public health issue, associated with significant morbidity and mortality. Adolescents and emerging adults are at particularly high risk because substance use t...

    Background: Substance use is an alarming public health issue, associated with significant morbidity and mortality. Adolescents and emerging adults are at particularly high risk because substance use typically initiates and peaks during this developmental period. Mobile health apps are a promising data collection and intervention delivery tool for substance-using youth, as most teens and young adults own a smartphone. However, engagement with data collection for most mobile health applications is low and often large fraction of users stop providing data after a week of use. Objective: Substance Abuse Research Assistant (SARA) is a mobile application to increase and/or sustain engagement of substance data collection overtime. SARA provides a variety of engagement strategies to incentivize data collection: a virtual aquarium in the app grows with fish and aquatic resources; occasionally funny or inspirational contents (e.g., memes or text messages) are provided to generate positive emotions. We plan is to assess the efficacy of SARA’s engagement strategies over time by conducting a micro-randomized trial, where the engagement strategies will be sequentially manipulated. Methods: We aim to recruit participants (ages 14-24, who report any binge-drinking or marijuana use in the past month. Participants are instructed to use SARA for one month. During this month, participants are asked to complete one survey and two active tasks every day between 6PM and midnight. The survey assesses participants’ daily mood, stress level loneliness, and hopefulness, while the active tasks measure reaction time and spatial memory. To incentivize and support the data collection, a variety of engagement strategies are used. First, pre-data collect strategies include: (i) At 4PM, a push notification may be issued with an inspirational message from a contemporary celebrity; or, (ii) At 6PM, a push notification may be issued reminding about data collection and incentives. Second, post-data collection strategies include various rewards such as points which can be used to grow a virtual aquarium with fishes and other treasures and modest monetary rewards (up to $13; $1 for each 3-day streak); also, participants may receive funny/inspirational content as memes/gifs, or visualizations of prior data. During the study, participants will be randomized every day to receive different engagement strategies. Results: The micro-randomized trial started on August 21, 2017 and is currently recruiting. The trial will end on February 28, 2018. Conclusions: To the best of our knowledge, SARA is the first mobile phone app that systematically manipulates engagement strategies in order to identify the best sequence of strategies that keep participants engaged in data collection. Once the optimal strategies to collect data are identified, future versions of SARA will use this data to provide just-in-time adaptive interventions (JITAIs) to reduce substance use among youth. Clinical Trial:

  • Effect of peripheral defocus on axial eye growth and modulation of refractive error in hyperopes

    Date Submitted: Jan 21, 2018

    Open Peer Review Period: Jan 23, 2018 - Feb 6, 2018

    Hyperopia is a known risk factor for the development of strabismus and amblyopia. In addition to visual consequences there is a growing body of evidence that uncorrected hyperopia may have a negative...

    Hyperopia is a known risk factor for the development of strabismus and amblyopia. In addition to visual consequences there is a growing body of evidence that uncorrected hyperopia may have a negative impact on educational attainment and visuocognitive and visuomotor skills. Currently, hyperopia receives much less attention from research than myopia even though the impact of moderate to high levels of hyperopia especially in one eye (anisohyperopia) can lead to amblyopia if not corrected fully at a young age. Hyperopia occurs as a consequence of insufficient ocular growth and a failure to emmetropise in childhood with the majority of hyperopic refractive errors resulting from an eye that is too short for its refractive power. In anisohyperopia it is unclear why one eye may remain hyperopic while the fellow eye grows towards an emmetropic state. Studies on animals have suggested that manipulating peripheral defocus through an optical means while simultaneously providing correct axial focus can either discourage or encourage axial eye growth to effectively treat myopia or hyperopia, respectively. Recent research has established that progression of myopia and axial eye growth can be significantly reduced in children and adolescents through the use of bifocal or multifocal contact lenses. These contact lenses while correcting the distance central myopia impose simultaneous myopic defocus. In recent years there has been a great deal of interest in delaying progression of myopia (short-sightedness) by slowing eye growth using a particular type of contact lens termed a centre-distance multifocal design. There have been encouraging results in this area to date. The proposed study here would explore the use of centre-near multifocal design contact lenses to encourage eye growth, thereby reducing hyperopia. There are three elements to the programme of research: 1. The natural progression of axial eye growth and refractive error will be measured in spectacle wearing hyperopic and anisohyperopic subjects aged between 5 and <19 years. In other words, the natural growth of the eye will be followed without intervention 2. As a paired eye control study anisohyperopes aged between 8 and <16 years will be fitted with a centre-near multifocal design contact lens in their more hyperopic eye and a single vision contact lens in the fellow eye if required. The progression of axial eye growth and refractive error will be measured and compared 3. Subjects aged between 8 and <16 years with similar levels of hyperopia in each eye will be fitted with centre-near multifocal design contact lenses in each eye. The progression of axial eye growth and refractive error will be measured and compared to subjects in the natural progression study. The objectives of the study are to: • Understand the natural progression of axial eye growth and refractive error in hyperopes and anisohyperopes • Establish if axial eye growth and refractive error can be modified using centre-near multifocal design contact lenses in hyperopes and anisohyperopes to improve visual outcome.

  • Early detection of cardiovascular changes after radiotherapy for breast cancer: Protocol for a European multicenter prospective cohort (MEDIRAD EARLY HEART Study)

    Date Submitted: Jan 22, 2018

    Open Peer Review Period: Jan 23, 2018 - Feb 6, 2018

    Background: Breast cancer (BC) is the most common cancer among women and radiotherapy (RT) plays a major role in its treatment. However, BC RT can lead to incidental irradiation of the heart, resultin...

    Background: Breast cancer (BC) is the most common cancer among women and radiotherapy (RT) plays a major role in its treatment. However, BC RT can lead to incidental irradiation of the heart, resulting in an increased risk of a variety of heart diseases arising many years after radiotherapy. Therefore, identifying BC patients with the highest-risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy ageing. There is still a need of precise knowledge on the relationship between radiation dose to specific cardiac structures and early subclinical cardiac changes and their occurrence in time that could finally lead to cardiac complications. Objective: The MEDIRAD EARLY HEART study aims to identify and validate new cardiac imaging and circulating biomarkers of radiation-induced cardiovascular changes arising in the first 2 years after BC RT and to develop risk models integrating these biomarkers combined with precise dose metrics of cardiac structures based on 3D-dosimetry. Methods: EARLY HEART study is a multicenter prospective cohort study that will include 250 women treated for breast cancer and followed for 2 years after RT. Women treated with RT without chemotherapy, for a unilateral breast cancer and aged 40 to 75 years meet the inclusion criteria. Baseline and follow-up data include cardiac measurements based on 2D-speckle-tracking-echocardiography, on coronary computed tomography angiography, on cardiac magnetic resonance imaging and a wide panel of circulating biomarkers of cardiac injury. The absorbed dose is evaluated globally for the heart and different substructures. Dose-response relationship will allow modeling radiation-induced occurrence and evolution of subclinical cardiac lesions and biomarkers in order to develop prediction models. Results: The article details the protocol of the MEDIRAD EARLY HEART study, and presents main limits and advantages of this international project. Inclusion of patients began in August 2017. Preliminary results are expected to be published in 2019, and complete analysis should be published in 2021. Conclusions: The MEDIRAD EARLY HEART study will allow identifying the main cardiac imaging and blood-based determinants of radiation-induced cardiac injuries to better propose primary and secondary preventive measures in order to contribute to enhanced patients’ care and quality of life. Clinical Trial: NCT03297346 -

  • Implementation and Evaluation of a Smartphone-based Telemonitoring Program for Patients with Heart Failure: A Mixed Methods Study Protocol

    Date Submitted: Jan 22, 2018

    Open Peer Review Period: Jan 22, 2018 - Feb 5, 2018

    Background: Meta analyses of telemonitoring for patients with heart failure conclude that it can lower the utilization of health services and improve health outcomes compared to the standard of care....

    Background: Meta analyses of telemonitoring for patients with heart failure conclude that it can lower the utilization of health services and improve health outcomes compared to the standard of care. A smartphone-based telemonitoring program is being implemented as part of the standard of care at a specialty care clinic for patients with heart failure in Toronto, Canada. Objective: The objectives of this study are to : 1) evaluate the impact of the telemonitoring program on health service utilization, patient health outcomes and their ability to self-care; 2) identify the contextual barriers and facilitators of implementation at the physician and clinic/institution level; 3) describe patient usage patterns to determine adherence and other behaviours in the Medly Program; and 4) evaluate the costs associated with implementation of the telemonitoring program from the perspective of the healthcare system(i.e., public payer), hospital, and patient. Methods: The evaluation will use a mixed method approach. The quantitative component will include a pragmatic pre-test-post-test study design for the impact and cost analyses which will make use of clinical data and questionnaires administered to at least 108 patients at baseline and 6 months. Outcome data will also be collected at 1 month, 12 months, and 24 months to explore the longitudinal impact of the program. In addition, quantitative data related to implementation outcomes and patient usage patterns of the telemonitoring system will be reported. The qualitative component involves an embedded single case study design to identify the contextual factors that influenced the implementation. The implementation evaluation will be completed using semi-structured interviews with clinicians, and other program staff at baseline, 4 months and 12 months after the program start date. Interviews with patients conducted with patients will be triangulated with usage data to explain usage patterns and adherence to the system. Results: The telemonitoring program was launched in August 2016 and patient enrollment is ongoing. Conclusions: The methods described provide an example for conducting comprehensive evaluations of telemonitoring programs. The combination of impact, implementation, and cost evaluations will inform quality improvement of the existing program and will yield insights into the sustainability of smartphone-based telemonitoring programs for heart failure patients within a specialty care settings.

  • Engagement Strategies for Self-Monitoring Symptoms of Bipolar Disorder with Mobile and Wearable Technology: Protocol Paper for a Randomized Control Trial

    Date Submitted: Jan 21, 2018

    Open Peer Review Period: Jan 22, 2018 - Feb 5, 2018

    Background: Monitoring of signs and symptoms in bipolar disorder is typically based on regular assessments from patient-clinician interactions. Mobile and wearable technology promises to make monitori...

    Background: Monitoring of signs and symptoms in bipolar disorder is typically based on regular assessments from patient-clinician interactions. Mobile and wearable technology promises to make monitoring symptoms in bipolar disorder easier, but little is known about how best to engage individuals with bipolar disorder in monitoring symptoms. Objective: To provide the rationale and protocol for a randomized control trial that investigates engagement strategies for monitoring symptoms of bipolar disorder, including using activity trackers compared to self-reports and reviewing recorded symptoms weekly with an interviewer. Methods: Fifty individuals with bipolar disorder will be recruited from the Prechter Longitudinal Study of Bipolar Disorder at the University of Michigan to participate in a six-week study. Participants will monitor their symptoms through an activity tracker (Fitbit Alta HR) and a smart-phone app designed for this study. In addition to monitoring symptoms, participants have a 50-50 chance of being assigned to an arm that reviews self-reports and activity information weekly. Statistical tests will be performed to test hypotheses that participants adhere to activity tracking significantly more than self-reporting; prefer activity tracking significantly more than self-reporting; and better adhere to both activity tracking and self-reporting when reviewing collected information weekly. Results: Recruitment began in November 2017. The first group of participants began the study in January 2018. Conclusions: The described study aims to establish strategies to engage bipolar individuals in monitoring their symptoms with mobile and wearable technology. Better engagement strategies are expected to aid current efforts in bipolar research and clinical care, from the development of new smart-phone apps to providing the right intervention to the right individual at the right moment. Clinical Trial: NCT03358238

  • Characteristics of cognitive behavioural therapy for older adults living in residential care: Protocol for a systematic review

    Date Submitted: Jan 21, 2018

    Open Peer Review Period: Jan 22, 2018 - Feb 5, 2018

    Background: The prevalence rates of depressive and anxiety disorders are high in residential aged care settings. Older adults in such settings may be prone to these disorders, because of losses associ...

    Background: The prevalence rates of depressive and anxiety disorders are high in residential aged care settings. Older adults in such settings may be prone to these disorders, because of losses associated with transitioning to residential care, uncertainty about the future, as well as a decline in personal autonomy, health, and cognition. Cognitive behavioural therapy (CBT) is efficacious in treating late-life depression and anxiety. However, there remains a dearth of studies examining CBT in residential settings, compared to community settings. Older adults living in residential settings typically have higher care needs than those living in the community. There are no systematic reviews on the content and the delivery characteristics of CBT for older adults living in residential aged care settings. Objective: The aim of this study was to describe the protocol for a systematic review on the characteristics of CBT for depression and/or anxiety for older adults living in residential aged care settings. Methods: The aim of the systematic review was to describe these characteristics of CBT for depression and/or anxiety for older adults living in residential care. This protocol was developed in compliance with the recommendations of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Studies that meet the inclusion criteria will be identified by systematically searching relevant electronic databases, reference lists, and citation indexes. The PRISMA flow chart will be used to record the process of selection. A pilot-tested data collection form will be used to extract and record data from the included studies. Two reviewers will be involved in screening the titles and abstracts of retrieved records, in screening the full-text of potentially relevant reports, and in extracting data. The delivery and the content characteristics of different CBT programs of the included studies, where available, will be summarised in a table. The Downs and Black checklist will be used to assess the methodological quality of the included studies. Results: Systematic searches will commence in April 2018, and data extraction is expected to commence in July 2018. Analyses and writing will take place in October 2018. Conclusions: Limitations of the systematic review will be outlined. Clinical implications for treating late-life depression and/or anxiety, and implications for residential care facilities will be discussed. Clinical Trial: Systematic review registration: PROSPERO CRD 42017080113