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)
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Latest Submissions Open for Peer-Review:View All Open Peer Review Articles
Design and rationale of NATURE-AF: the NAtional TUnisian REgistry of Atrial Fibrillation
Date Submitted: Jul 21, 2017
Open Peer Review Period: Jul 24, 2017 - Aug 7, 2017
Background: Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change on the epidemiological pattern of heart disease have been seen in the last three decades, however,...
Background: Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change on the epidemiological pattern of heart disease have been seen in the last three decades, however, no prospective, multicenter, large trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of atrial fibrillation (AF) patients in Tunisia are limited. Objective: the aim of this study was to analyze, follow and evaluate patients with AF in a large multicenter nation-wide trial. Methods: Methods: One thousand eight hundred consecutive patients with AF in their electrocardiogram, reflecting all the population of all geographical regions of Tunisian will be included in the study, with the objective to describe the epidemiological pattern of AF. Patients will be ofﬁcially enrolled in the NATURE-AF only if an ECG diagnosis(12-lead ECG, 24 h Holter, or other electrocardiographic documentation)conﬁrming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrolment. The patients will be followed up for one year. Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular deathwill be recorded as the primary end-point and haemorrhagic accidents, measurement of INR and percent Time In Therapeutic INR Range(TTR) will be recorded as the secondary end-points. Results: Results: Will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse eventswill be determined. NATURE AF will be the first largest registry for North African AF patients. Conclusions: Conclusion: This study would add data and would provide a valuable opportunity for ‘real world’ clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. Clinical Trial: ClinicalTrials.gov Identifier: NCT03085576 (registered on March 2017).
Title: The Tapering Practices of Strongman Athletes; A Test-Retest Reliability Study
Date Submitted: Jul 21, 2017
Open Peer Review Period: Jul 21, 2017 - Aug 4, 2017
Background: Currently, little is known about the tapering practices of strongman athletes. We have developed an Internet comprehensive self-report questionnaire examining the training and tapering pra...
Background: Currently, little is known about the tapering practices of strongman athletes. We have developed an Internet comprehensive self-report questionnaire examining the training and tapering practices of strongman athletes. Objective: The objective of this study was to document the test-retest reliability of questions associated with the Internet comprehensive self-report questionnaire on the tapering practices of strongman athletes. The information will provide insight on the reliability and usefulness of the online questionnaire for use with strongman athletes. Methods: Invitations to complete an Internet questionnaire were sent via ‘Facebook Messenger’ to identified strongman athletes. The survey consisted of four main areas of inquiry including; demographics and background information, training practices, tapering and tapering practices. Of the 454 athletes that completed the survey over the eight-week period, 130 athletes responded on ‘Facebook Messenger’ indicating that they were going to do or had completed the survey. These participants were asked if they could fill the online questionnaire in a second time for a test-retest reliability analysis. Sixty-four athletes (age, 33.3 ±7.7 y; height, 178.2 ±11.0 cm; body mass, 103.7 ±24.8 kg) accepted this invitation and completed the survey for the second time after a minimum 7-day period from the date of their first completion. Agreement between athlete responses was measured using ICC’s and kappa statistics. 95% Confidence intervals were reported for all measures and significance was set at p < 0.05. Results: Test-retest reliability for demographic and training practices items were significant (p < 0.001) and showed excellent (ICC range = .84 to .98) and fair to almost perfect (kappa range = .37 to .85) agreement. Moderate to excellent agreement (ICC range = .56 to .84; p < 0.01) were observed for all tapering practices measures except for the number of days’ athletes started their usual taper before a strongman competition (ICC = .30). When the number of days were categorized with additional analysis, moderate reliability was observed (kappa=.43; p <0.001). Fair to substantial agreement was observed for the majority of tapering practices measures (kappa range = .38 to .73; p <0.001) except for how training frequency (kappa=.26) and the percentage and type of resistance training performed changed in the taper (kappa=.20). Good to excellent agreement (ICC = .62 to .93; p < 0.05) was observed for items relating to strongman events and traditional exercises performed during the taper. Only the time at which the Farmers walk was last performed before competition showed poor reliability (ICC = .27). Conclusions: We have developed a low cost, self-reported, online retrospective questionnaire, which provided stable and reliable answers for most of the demographic, training and tapering practice questions. The results of this study support the inferences drawn from the tapering practices of strongman athletes study.
Uterine artery embolization versus hysterectomy in the treatment of symptomatic adenomyosis: design of the randomized QUESTA trial.
Date Submitted: Jul 19, 2017
Open Peer Review Period: Jul 21, 2017 - Aug 4, 2017
Background: Adenomyosis is a benign uterine disease characterized by invasion of endometrium into the myometrium resulting in heavy menstrual bleeding and pain (dysmenorrhea). Hysterectomy is establi...
Background: Adenomyosis is a benign uterine disease characterized by invasion of endometrium into the myometrium resulting in heavy menstrual bleeding and pain (dysmenorrhea). Hysterectomy is established as the final treatment option when conservative treatment fails. Uterine artery embolization (UAE) in patients with symptomatic adenomyosis has demonstrated to reduce symptoms and improve quality of life, however randomized controlled trials are lacking. Objective: With this study we aim to evaluate the impact of UAE on Health Related Quality of life (HRQOL) in a randomized comparison to hysterectomy in patients with symptomatic adenomyosis. Methods: This is a multicenter non-blinded randomized controlled trial comparing UAE and hysterectomy. Eligible patients are symptomatic premenopausal women without the desire to conceive and who have symptomatic MRI confirmed pure adenomyosis or dominant adenomyosis accompanied by fibroids. After obtaining informed consent, patients will be randomly allocated to treatment in a 2:1 UAE versus hysterectomy ratio. The primary objective is HRQOL at 6 months following the assigned intervention. Secondary outcomes are technical results, pain management, clinical outcomes, HRQOL, and cost effectiveness during 2 years of follow-up. In addition, transvaginal ultrasound (TVUS) and MRI will be performed at regular intervals after UAE. Results: Patient enrollment started November 2015. The follow-up period will be completed two years after inclusion of the last patient. At time of submission of this article data cleaning and analyses have not yet started. Conclusions: This trial will provide insight for care takers and future patients about the effect of UAE compared to the gold standard hysterectomy in the treatment of symptomatic adenomyosis and is therefore expected to improve patients’ wellbeing and quality of life. Clinical Trial: NetherlandsTrial Register NTR5615. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5615
Design and methods of Get Social: A non-inferiority trial comparing clinic- versus online social network-delivered lifestyle interventions
Date Submitted: Jul 20, 2017
Open Peer Review Period: Jul 21, 2017 - Aug 4, 2017
Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Though online social networks have been integrated as one component of multi-modality...
Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Though online social networks have been integrated as one component of multi-modality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network to a traditional clinic-delivered intervention. This paper describes the design and methods of a non-inferiority randomized controlled trial testing whether a lifestyle intervention delivered entirely through an online social network will produce weight loss that is not appreciably worse than a traditional clinic-based lifestyle intervention among overweight and obese adults, but at lower cost. Adults with BMI between 27-45 kg/m2 (N=328) will be recruited from the communities in central Massachusetts. Measures will be obtained at baseline, 6-, and 12-months after randomization. The primary non-inferiority outcome is percent weight loss at 12 months. Secondary non-inferiority outcomes include dietary intake, and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition. Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an efficacious alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models.
MyVoice National Text Message Survey of Youth 14-24yo: Study Protocol
Date Submitted: Jul 18, 2017
Open Peer Review Period: Jul 19, 2017 - Aug 2, 2017
Background: Adolescent health in the US has not improved in decades. Researchers and youth-serving organizations struggle to accurately elicit youth voice and translate youth perspectives into health...
Background: Adolescent health in the US has not improved in decades. Researchers and youth-serving organizations struggle to accurately elicit youth voice and translate youth perspectives into health care policy. Objective: Our aim is to describe the protocol of the MyVoice Project, a longitudinal mixed methods study designed to engage youth, particularly those not typically included in research. Text messaging surveys are collected, analyzed, and disseminated in real-time to leverage youth perspectives to impact policy. Methods: Youth age 14-24 are recruited to receive weekly text message surveys on a variety of policy and health topics. The research team, including academic researchers, methodologists, and youth, develop questions through an iterative writing and piloting process. Question topics are elicited from community organizations, researchers and policy makers to inform salient policies. A youth centered interactive platform has been developed that automatically sends confidential weekly surveys and incentives to participants. Parental consent is not required as the survey is of minimal risk to participants. Recruitment occurs online (e.g., Facebook, Instagram, UMHealthResearch.org), in person at community events, and through snowball sampling. Weekly surveys collect both quantitative and qualitative data. Quantitative data are analyzed using descriptive statistics. Qualitative data are quickly analyzed using natural language processing and traditional qualitative methods. Mixed methods integration and analysis supports a more in-depth understanding of the research questions. Results: We are currently recruiting and enrolling participants through in-person and online strategies. Question development, weekly data collection, data analysis, and dissemination are in progress. Conclusions: MyVoice quickly ascertains the thoughts and opinions of youth in real-time using a widespread, readily available technology– text messaging. Results are disseminated to policy makers and youth-serving organizations through a variety of methods. Policy makers and organizations then share their priority areas with the research team to develop additional question sets to inform important policy decisions. Youth-serving organizations can use results to make decisions to promote youth well being.
Psychosocial distress of patients with psoriasis: Assessment of care needs and development of a supportive intervention: a study protocol
Date Submitted: Jul 17, 2017
Open Peer Review Period: Jul 18, 2017 - Aug 1, 2017
Background: Psoriasis is a chronic inflammatory disease that is often associated with a number of somatic and mental comorbidity. Patients with psoriasis show an increased risk of depression and (soci...
Background: Psoriasis is a chronic inflammatory disease that is often associated with a number of somatic and mental comorbidity. Patients with psoriasis show an increased risk of depression and (social) anxiety. Objective: The aims of this study are 1) to explore the psychosocial distress of patients with psoriasis and to assess their care needs; 2) to develop a supportive intervention based on the prior results. Methods: A multi-stage design with four phases combining quantitative and qualitative methodology will be used and conducted in two centers. 1) A scoping review and focus groups will be used to design a questionnaire to assess the psychosocial distress and care needs of the patients. 2) The questionnaire developed in phase 1 will be used in a cross-sectional survey to assess the extent of psychosocial distress and supportive care needs in patients with psoriasis. 3) A systematic review and meta-analysis will be conducted to identify psychosocial and psychoeducational interventions for patients with psoriasis and to describe their effectiveness. 4) Based on the results of the phases 2 and 3 a manualized supportive intervention will be developed and the feasibility and acceptance of the intervention will be assessed. Conclusions: The expected results of this study will show the extent of psychosocial distress of patients with psoriasis in Germany and supplement previous research with findings about the supportive care needs of this patient group. Moreover the developed intervention will help to address the psychosocial support needs of patients with psoriasis. Research shows that psychosocial support is strongly needed.