JMIR Research Protocols
Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
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)
Oct 16, 2017
Oct 13, 2017
Oct 12, 2017
Oct 11, 2017
Oct 11, 2017
Oct 10, 2017
Oct 10, 2017
Oct 6, 2017
Oct 3, 2017
Oct 2, 2017
Sep 29, 2017
Sep 28, 2017
Citing this Article
Right click to copy or hit: ctrl+c (cmd+c on mac)
Latest Submissions Open for Peer-Review:View All Open Peer Review Articles
An integrated approach to fight parasitic worm infections and diarrhoea: a cluster randomised trial study protocol
Date Submitted: Oct 12, 2017
Open Peer Review Period: Oct 14, 2017 - Oct 28, 2017
Background: The global strategy to control helminthiases emphasises preventive chemotherapy. However, in the absence of access to clean water, improved sanitation and adequate hygiene, re-infection af...
Background: The global strategy to control helminthiases emphasises preventive chemotherapy. However, in the absence of access to clean water, improved sanitation and adequate hygiene, re-infection after treatment can occur rapidly. Hence, integrated approaches are necessary to sustain preventive chemotherapy and make progress towards interruption of helminthiases transmission. Objective: The aim of the current study is to assess and quantify the effect of an integrated control package that consists of preventive chemotherapy, community-led total sanitation (CLTS) and health education, on soil-transmitted helminthiasis, schistosomiasis, intestinal protozoa infection and diarrhoea in rural Côte d’Ivoire. Methods: In a first step, a community health education programme will be developed that includes an animated cartoon for hygiene and health targeting school-aged children, coupled with a community health education theatre for the entire community. In a second step, a cluster randomised trial will be implemented in 56 communities of south-central Côte d’Ivoire with four intervention arms: (i) preventive chemotherapy; (ii) preventive chemotherapy plus CLTS; (iii) preventive chemotherapy plus health education; and (iv) all three interventions combined. In a third step, a baseline parasitological, anthropometric and hygiene-related knowledge, attitudes, practices and beliefs (KAPB) survey will be conducted. These surveys will be repeated 18 and 39 months after the baseline cross-sectional survey to determine the effect of different interventions on helminth and intestinal protozoa infection, nutritional indicators and KAPB. Monitoring of diarrhoea will be done over a 24-month period at 2-week intervals, starting right after the baseline survey. Results: This study will allow determining the effect of an integrated, community-based approach on infection patterns of intestinal parasites and diarrhoeal incidence, anthropometric measures and hygiene-related KAPB. Conclusions: The acceptability of an integrated control package in the community will be evaluated, including strengths and limitations. Clinical Trial: ISRCTN53102033 (assigned: 26 March 2014).
Type 1 Doing Well: Randomized Pilot Study Protocol for a Strengths-Based Behavioral Intervention for Parents of Adolescents with Type 1 Diabetes Using an mHealth App
Date Submitted: Oct 13, 2017
Open Peer Review Period: Oct 14, 2017 - Oct 28, 2017
Background: Supportive parent involvement for adolescents’ type 1 diabetes self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative...
Background: Supportive parent involvement for adolescents’ type 1 diabetes self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. Objective: This protocol describes the development of a new, strengths-based behavioral intervention for parents of adolescents with type 1 diabetes delivered via mobile-friendly web app called Type 1 Doing Well. Methods: Ten adolescent-parent dyads and five diabetes care providers participated in a series of qualitative interviews to inform the design of the app. The 3-month pilot intervention will involve n=82 parents receiving daily prompts to use the app, in which they will mark the diabetes-related strength behaviors (i.e., positive attitudes or behaviors related to living with or managing type 1 diabetes) their teen engaged in that day. Parents will also receive training on how to observe diabetes strengths and how to offer teen-friendly praise via the app. Each week, the app will generate a summary of the teen’s most frequent strengths from the previous week based on parent reports, and parents will be encouraged to praise their teen either in person or from a library of reinforcing text messages. Results: The major outcomes of this pilot study will include intervention feasibility and satisfaction data. Clinical and behavioral outcomes will include glycemic control, regimen adherence, family relationships and conflict, diabetes burden, and health-related quality of life. Conclusions: This strengths-based, mHealth intervention aims to help parents increase their awareness of and efforts to support their adolescents’ engagement in positive diabetes-related behaviors. If efficacious, this intervention has the potential to reduce the risk of family conflict, enhance collaborative family teamwork, and ultimately improve diabetes outcomes. Clinical Trial: NCT02877680
Cultural and contextual adaptation of an eHealth intervention: Adaptation framework and protocol for Horyzons-Canada
Date Submitted: Oct 12, 2017
Open Peer Review Period: Oct 14, 2017 - Oct 28, 2017
Background: eHealth interventions have the potential to address challenges related to access, service engagement, and continuity of care in the delivery of mental health services. However, the initial...
Background: eHealth interventions have the potential to address challenges related to access, service engagement, and continuity of care in the delivery of mental health services. However, the initial development and evaluation of such interventions can require substantive amounts of financial and human resource investments to bring them to scale. Therefore, it may be warranted to increase policy, services, and research attention on eHealth platforms that have the potential to be adapted for use across settings. Yet, limited attention has been placed on the methods and processes for adapting eHealth interventions to improve their applicability across cultural, geographical, and contextual boundaries. Objective: In this paper, we describe an adaptation framework and protocol to adapt an eHealth intervention designed to promote recovery and prevent relapses in youth receiving specialized services for first-episode psychosis. The online platform, called Horyzons, was originally developed and tested in Australia and is being prepared for a wider evaluation in Canada. Methods: Service users and service providers from two specialized early intervention programs for first-episode psychosis located in different provinces will explore a beta-version of the eHealth intervention through focus group discussions and extended personal explorations to identify the need for, and content of contextual and cultural adaptations. An iterative consultation process will then take place with service providers and users to develop and assess platform adaptations in preparation for a pilot study with a live version of the platform. Results: Data collection has been completed August 2017 and analysis is in process. Conclusions: This protocol contributes to an important gap in the literature pertaining to the specific principles, methods and steps involved in conducting a systematic reflection and change process in scaling up the evaluation of eHealth interventions across a diverse range of healthcare settings. Clinical Trial: N/A
DIABEO-telemedicine versus usual follow-up in the treatment of diabetic patients poorly controlled with a basal-bolus insulin regimen: the TELESAGE randomized, open label trial
Date Submitted: Oct 10, 2017
Open Peer Review Period: Oct 13, 2017 - Oct 27, 2017
Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal....
Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a software application uploaded onto smartphones (with an Internet connection) for calculation of bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO is associated with a significant improvement of glycemic control in poorly controlled diabetes type 1 (DT1) patients, particularly when combined with physicians’ teleconsultations. Here, we present the protocol of a new study (TELESAGE) conducted in a larger population of poorly controlled diabetic patients. Methods: TELESAGE is a multicentre, double-randomized, open-label, three parallel-arms study, conducted in approximately 100 centers in France. The study compares a control group (arm 1: usual follow-up) versus two DIABEO-telemedicine systems: one with physician-telemedicine (arm 2) and the other with nursing tele-monitoring and teleconsultations by diabetologist’s task delegation (arm 3). A first randomization step will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE is to demonstrate the superiority of a 12-month follow-up by the DIABEO-telemedicine system versus usual follow-up, with respect to improvement of HbA1c levels in approximately 696 DT1 or DT2 patients poorly controlled by a basal-bolus insulin regimen. Here, we present the baseline the protocol of the TELESAGE study. Discussion: The TELESAGE study is expected to confirm the previous results of TELEDIAB 1 study in a larger sample of diabetic patients. It is also expected to evaluate a nurse tele-monitoring system. If this is the case, the DIABEO-telemedicine service will clearly demonstrate its utility to become an integral part of the ambulatory care of an intensive insulin regimen treated patient. The study was registered by the French ANSM (Agence Nationale de Sécurité du Médicament; National Agency for Drug Safety) under Trial ID number: 2012-A00072-41.
Evaluating the CARE4Carer blended care intervention for partners of patients with acquired brain injury: protocol for a randomized controlled trial
Date Submitted: Oct 8, 2017
Open Peer Review Period: Oct 9, 2017 - Oct 23, 2017
Background: Support programs for partners of patients with acquired brain injury are necessary, since these partners experience several unfavorable consequences of caregiving, such as a high burden, e...
Background: Support programs for partners of patients with acquired brain injury are necessary, since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psycho-education, skill building, problem solving and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. Objective: This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. Methods: A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. Results: The effect of the intervention on the primary and secondary outcome measures will be determined. Additional economic and process evaluations will be conducted. Conclusions: The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. Clinical Trial: Dutch Trial Register NTR6197, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197
Influence of radiofrequency electromagnetic waves on fertility system: A protocol of systematic review and meta-analyses
Date Submitted: Oct 3, 2017
Open Peer Review Period: Oct 9, 2017 - Oct 23, 2017
Background: Concerns about the potential impact of mobile health are growing, which has increased the user of the mobile phone, tablet, etc. over the past few years. Cell phones, wireless telephones,...
Background: Concerns about the potential impact of mobile health are growing, which has increased the user of the mobile phone, tablet, etc. over the past few years. Cell phones, wireless telephones, mobile base stations and power lines are one of the main sources of our daily exposure to radiofrequency electromagnetic radiation (RF-EMR). There are more than 2 billion mobile phones in use worldwide (1-3). Exposure to RF energy depends on the frequency of the mobile phone used. The most common frequency of used phones is 1900-900 MHz in the United States, while in many parts of the world these phones work at frequencies from 1800 to 850 MHz. The higher frequency has the higher energy. Radial energy is absorbed by the three main mechanisms in the human body: (i) aueral effect: The body receives and absorbs the RF signal depending on the size of the body part and the signal wavelength; (ii) RF signal binding with tissue; and (iii) absorption intensification (4,5). The effects of electromagnetic radiation can be divided into two main categories - thermal properties and non-thermal properties. The thermal properties caused by the increase in temperature due to the energy absorption of oscillating electric fields. This can lead to heat in the exposed parts of the body. Thermal effects are calculated in terms of SAR (specific absorption rate) calculation. This SAR depends largely on the antenna, location, and frequency settings (6). Some studies showed that human exposure to radiofrequency waves can cause cognitive, behavioral impairments and decreased learning and memory. Also, induce significant thermal effects may be associated with adverse health effects such as sleep problems, impairment of the nervous system, health problems, and increased cancer risk, hearing and reproductive (7,8). Infertility is an inability to get pregnant after one year of intercourse without the use of contraceptive methods and affecting 15% of couples. 30-50% of the infertility causes related to male infertility, as well as 40 to 30% of the male infertility causes referred to sperm disorders (9). The influence of mobile exposure on man fertility have been studied in recent years.  In normal physiological conditions, spermatogenesis is a balanced process of maturation, cell division, and storage, which is particularly susceptible to environmental stimuli and chemical. However, its mechanism is unclear but they guess that particularly sensitive could be Cytoskeleton, consist of charged proteins: middle actions, and microtubules. The cytoskeleton is structural and functional part of the cell that plays a main role in motility of the sperm and is actively participates the morphological alterations that happen during mammalian sperm genesis (10-11). A study of EMFs effects on female rats using a transmission electron microscopy (TEM), representing an increase existence of numerous drops of lipid in patches and luteal cells also increase in the number of autophilia vaccines and macrophages in some granulosic cells (12). Other researchers showed that EMFs increase macrophages in the range of lutea corpora and growing follicles. They believe that EMFs increase apoptosis in mice ovaries. In addition, most researchers believe that EMF damage stromal cells in the uterine and uterine tubes through apoptosis to the glandular epithelium, ovarian cortex, luminal epithelium (13, 14). Now it is necessary to explore the safety criteria for these radiations in the direction toward future research. The physical phenomena of electronic devices that exposed RF are very close to the body. Therefore, it could be used RF shielding in electronic devices that can block RF-EMF waves, various time scales for a fixed minute with intermittent and increasing distance from them. Systematic review papers are a type of review that analyzes the findings of other studies and provide the best evidence for decision about health approach (15). yildirim et al(2015) in assessing the potential harmful effects of RF on sperm parameters, we found that there is no significant difference between sperm counts and sperm morphology excluding sperm motility, due to mobile phone usage period(16). Due to conflicting results and since no systematic review performed the effects of RF-EMF exposed from other electronic devices on fertility system in recent year, the evidence base study is necessary. Objective: The main objectives of this study are to clarify the best evidence associated with the influence of radiofrequency electromagnetic field on the male and female reproductive system and considered any common observations that could provide insights on a potential mechanism. The other objective of this study is determining the effect of a radiofrequency electromagnetic field on primary or secondary infertility. Methods: Inclusion criteria Types of participants -Couples who were infertile (inability to get pregnant after one year of intercourse without the use of contraceptive methods) -Infertile male and women 18–65-year-old who used the radio-frequency electromagnetic device for various exposure times -infertile couples did not have any underlying disease - Hormonal assessment, diagnostic imaging techniques, biopsy, spermatograms were used to assess the reproductive system. - No limitation in frequency and duration use of device Type of intervention This systematic review will include only human studies that participants used any device that exposed radiofrequency electromagnetic waves for any frequency and duration. No restriction has in exposure condition, type of signal device, distance and exposure time. Comparator All studies with or without the control group will be included in this study. Outcomes This current systematic review will consider papers that include change rate in reproductive system parameters after the use of radio-frequency electromagnetic devices (Sperm and endocrine parameter, testis, and ovary function) as primary outcomes. The secondary outcomes will be primary or secondary infertility. The outcomes measurement will be assessed by hormonal assessment, diagnostic imaging techniques, biopsy, and spermatograms. Types of studies Any observational study designs will be included. Case reports and case series, review, and letter to the editor article will not be included. Articles with incomplete data were excluded from the study. We will try to contact the authors by email whose studies related but not accessible. Search strategy In this systematic review, the databases and gray literatures will be searched with no language and date limitation. The following databases were " Cochrane Library (Wiley), MEDLINE (Ovid), Pub Med, EMBASE, CINAHL (EBSCO), ProQuest, Scopus, Science Direct, Google Scholar "and Persian databases. Also, the reference lists of articles and reports will be checked. The gray literatures will be included the International Clinical Trials Registry Platform, Dissertations, Thesis Global, and Thesis. The combination of the mesh terms "radiofrequency electromagnetic", and "male reproductive system" or "female reproductive system" will be used for searching. To ensure the inclusion of all the related articles, search will be sensitive. The title and abstract of the articles would be evaluated ; any disagreement will be resolved through the discussion between authors. The full-text of articles will be assessed to the objectives of this systematic review. Quality assessment Papers selected for retrieval will be evaluated by two independent referees for methodological validation before entering the review using the standard evaluation tool "OTTAWA" for cohort studies and non-randomized controlled trials. (17). Any differences which rises between reviewers, will be resolved through conversation or with a third reviewer. Data extraction The data from the articles extracted in this study using the standard data extraction tool that is accessible in JBI-SUMARI by two independent reviewers. The data extracted will comprise specific details about the populations, interventions, study methods and results are important to the question of review and particular goals. Any differences that arise will be resolved through discussion or with a third reviewer. Authors of papers will be contacted to request missing or additional data where required. We will try to contact the corresponding authors of studies by email if it is necessary to obtain data missing from published articles. Data synthesis By using STATA V.12 software, analyses will be conducted. Heterogeneity will be evaluated by the I2 statistic, and χ2 test (recommended by the Cochrane Handbook for Systematic Reviews of Interventions). We will explain the I2 statistic using the guide. When substantial heterogeneity (I2>50%) is evident among the articles, the results of this study will be presented in the text qualitatively. The author's decision to use the random-effects model will be based on understanding of whether not all included trials share a common effect size, They are not only on results of tests but also on statistical heterogeneity. All results of this paper will be given to two inputs. For classified data the effect sizes are calculated as OR and for continuous data the weighted average difference and their 95% CI for analysis. By using the standard x2 Non-correlation will be evaluated. If statistical data of studies do not collect, the results of this article will be presented in the appropriate tables and figures. By using a funnel plot, Begg's, and Egger's tests publication bias will be explored. If it is possible, this systematic review will be performed subgroup meta-analysis based on the type of device and exposure time disagreement. Results: This is a protocol for a systematic review, and the result is not presented. The results of this study will be submitted to a peer-reviewed journal for publication and also presented at PROSPERO (International prospective register of systematic reviews), which the number of PROSPERO is CRD42017072462. Conclusions: The purpose of systematic review is to present the comprehensive summary of related article to a study question and it can be the best answer to the controversy between studies (18). This systematic review will provide the evidence base data about the effect of radiofrequency electromagnetic waves on fertility system changes. This article will also classify the harmful effect of RF waves on primary and secondary infertility. Due to the growth of infertility rate among people, negative outcomes of this problem for couple, and heath care system, the results of this study can be useful for decrease the infertility rate (19).