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
Treatment of low back pain with a mobile health app: a digital multidisciplinary pain treatment tool reveals significant pain reduction in a short-term follow-up
Date Submitted: Sep 25, 2017
Open Peer Review Period: Sep 25, 2017 - Oct 9, 2017
Background: Even though modern concepts of disease management of unspecific low back pain (LBP) postulate active participation of patients, this strategy is difficult to adapt unless multidisciplinary...
Background: Even though modern concepts of disease management of unspecific low back pain (LBP) postulate active participation of patients, this strategy is difficult to adapt unless multidisciplinary pain therapy is applied. Recently, mhealth solutions have proven to be effective aides to foster self-management of many diseases. Objective: Here we report on retrospective short-term results of a digital multidisciplinary pain app for the treatment of low back pain. Methods: Kaia is a mobile app that digitalizes multidisciplinary pain treatment and is in the market as a medical product class I. For the current study, we retrospectively analyzed the data of anonymized Kaia users. User data were evaluated for 12 weeks regarding duration of use and effect on in-app user reported pain levels (NRS) depending on whether LBP was classified as acute, subacute or chronic back pain according to current guidelines. Results: Overall, data of 180 users were available. Mean age of the users was 33.9 years (SD=10.9). Pain levels decreased from baseline (BL) NRS 4.8 to 3.75 for all users at the end of the observation period. Users who completed 4, 8 or 12 weeks respectively showed an even more pronounced decrease in pain level NRS (BL 4.9 ± 1.7 vs 3.6 ± 1,5 at 4 weeks; BL 4.7 ± 1.8 vs 3.2 at 8 weeks; BL 4.6 ± 2.2 vs 2.6 ± 2.0 at 12 weeks). In addition, subgroup analysis of acute, subacute or chronic classification revealed no significant main effect of group (p> .30) on the reduction of pain. Conclusions: The current retrospective analysis shows that in a pre-selected population of app users, an app digitalizing multidisciplinary rehabilitation for the self-management of LBP reduces pain levels significantly. This effect increases if users adhere to the program for longer periods. The results of this retrospective observation of user data are currently validated in a prospective RCT- trial to adjust for potential bias and also address other outcomes like mobility, functionality or psychometric measures.
Effects of Drug Interventions with Combined Oral Contraceptives on the hypothalamic–pituitary–gonadal axis in patients with polycystic ovary syndrome: Protocol for systematic review and meta-analysis
Date Submitted: Sep 22, 2017
Open Peer Review Period: Sep 23, 2017 - Oct 4, 2017
Background: Selection of combined oral contraceptives (COCs) with maximum antiandrogenic effects is one the most important issues in treatment of patients with polycystic ovary syndrome (PCOS). Object...
Background: Selection of combined oral contraceptives (COCs) with maximum antiandrogenic effects is one the most important issues in treatment of patients with polycystic ovary syndrome (PCOS). Objective: This systematic review and meta-analysis protocol aimed to compare the effects of COCs containing progestins with low androgenic and antiandrogenic activities on the hypothalamic–pituitary–gonadal (HPG) axis in patients with PCOS. Methods: We searched PubMed, Scopus, Google Scholar, ScienceDirect, and Web of Science databases (1980–2017) to identify randomized clinical trials (RCTs) or non-randomized studies (NRS) investigating the effect of COCs containing progestins with low androgenic and antiandrogenic activities including products containing desogestrel (DSG), cyproterone acetate (CA) and drospirenone (DRSP) on the HPG axis in patients with PCOS. In this meta-analysis, fixed and random effect models were used. Outcomes interested were follicle stimulating hormone (FSH), luteinizing hormone (LH), LH to FSH ratio, estradiol (E2), total testosterone (TT) and sex hormone-binding globulin (SHBG). Potential sources of heterogeneity were investigated using meta-regression and subgroup analyses. Subgroup analyses were performed based on used progestin compound and treatment duration. We assessed quality of included studies and their risk of bias using Cochrane guidelines. Publication bias were assessed using Egger’s test and Funnel plot. Results: COC use was significantly associated with a decrease in gonadotropin levels including FSH and LH. Use of products containing CA was associated with a decrease in FSH after 3 months (WMD= -0.48; 95% CI: -0.81, -0.15), 6 months (WMD = -2.33; 95% CI: -3.48, -1.18) and 12 months (WMD = -4.70; 95% CI: -4.98, -4.42) and LH levels after 3 months (WMD = -3.57; 95% CI: -5.14, -1.99), after 6 months (WMD = -5.68; 95% CI: -9.57, -1.80), and after 12 months (WMD = -11.60; 95% CI: -17.60, -5.60). COCs containing DRSP for 6 months decreased FSH (WMD = -0.93; 95% CI: -1.79, -0.08) and LH (WMD = -4.59; 95% CI: -7.53, -1.66). Data for products containing desogestrel were few, but this compound generally had no influence on gonadotropin levels similar to that observed with COCs containing CA and DRSP. Use of COCs was not associated with any significant change in LH to FSH ratio. COCs containing CA showed maximum effect on gonadotropin suppression. COCs containing CA significantly decreased E2 concentrations, whereas those containing DRSP exhibited no such effect. All COCs demonstrated improvement in androgenic profile and had the same effects on TT and SHBG concentrations. Progestin compound and treatment duration had no important effects on changing TT and SHBG levels. Conclusions: COCs containing progestins with low androgenic and antiandrogenic activities can suppress gonadotropins, leading to a decrease in androgenic profiles in women with PCOS. All studied COCs showed the same effects on androgenic profile, whereas products containing CA had maximum effects in suppressing gonadotropin and E2 levels.
Physical trauma patients with symptoms of an acute and post-traumatic stress disorder: an observational prospective cohort study
Date Submitted: Sep 20, 2017
Open Peer Review Period: Sep 23, 2017 - Oct 7, 2017
Background: Injury, medical treatment and rehabilitation can have a major impact on patients’ wellbeing. About 25-33% of the patients experience an acute (ASD) or post-traumatic stress disorder (PTS...
Background: Injury, medical treatment and rehabilitation can have a major impact on patients’ wellbeing. About 25-33% of the patients experience an acute (ASD) or post-traumatic stress disorder (PTSD) after injury. ASD is a relatively new diagnosis. Therefore, knowledge about patients’ experiences, the course and who is at risk for developing ASD or PTSD is lacking. Objective: The aims of this multi-method study are to explore patients’ experiences with injury (care) using a focus group study. Then, in the observational study (possible) different courses of ASD, PTSD, and quality of life (QOL) will be examined. In addition, this study will examine if these courses could be characterized by socio-demographic, clinical, and psychological variables. Consequently, a risk profile will be developed to determine which patients are at risk for developing ASD and/or PTSD during 12 months after injury. Methods: Trauma patients treated in the shock room (2015) of the Elisabeth-TweeSteden Hospital will share their experiences with injury in the focus group study. Open, axial, and selective coding will be used to analyze the data. Concerning the observational study, patients treated in the shock room (during 2016 and 2017, Elisabeth-TweeSteden Hospital and Erasmus Medical Centre) will be asked to participate. The inclusion period is 12 months. Participants will complete the Impact of Event Scale-Revised, MINI-plus, the Hospital Anxiety and Depression Scale, and the World Health Organization Quality of Life-BREF after inclusion and at 3, 6, 9, and 12 months after injury. The NEO-Five Factor Inventory and the State-Trait Anxiety Inventory-Trait are completed after inclusion only. Repeated measures latent class analysis and linear mixed models repeated measures will be used to examine the research aims. Results: This project was funded in August 2015 by ZonMW. The results of the focus group study are expected in the first trimester of 2018. With regard to the observational study, recruitment is currently underway. Data collection will be completed in November 2018. Then, the first results will be expected in the first trimester of 2019. Conclusions: This is the first multi-method study in trauma patients that examines patients’ experiences (qualitative design) as well as psychological disorders (observational prospective). This study will contribute to the need for information on psychological consequences after injury. Moreover, it provides knowledge about which patients to include in future psychological intervention research. Finally, awareness in clinicians about the psychological consequences can be created, so they are able to act more effective to provide patient-oriented care. Clinical Trial: NTR6258
Protocol for a systematic review of substance use prevention programs for Indigenous adolescents in the United States of America, Canada, Australia and New Zealand
Date Submitted: Sep 20, 2017
Open Peer Review Period: Sep 21, 2017 - Oct 5, 2017
Indigenous adolescents are at higher risk of experiencing harms related to substance use, compared to their non-Indigenous counterparts as a consequence of earlier onset and higher rates of substance...
Indigenous adolescents are at higher risk of experiencing harms related to substance use, compared to their non-Indigenous counterparts as a consequence of earlier onset and higher rates of substance use. Early onset of substance use has been identified as a risk factor for future substance use problems and other health, social and family outcomes. Therefore, prevention of substance use among adolescents has been identified as a key area to improve Indigenous health. Evidence exists for the effectiveness of substance use prevention approaches for adolescents in mainstream populations and most recently, for the use of computer- and internet-delivered interventions to overcome barriers to implementation. However, there is currently no conclusive evidence about the effectiveness of these approaches for Indigenous adolescents. The purpose of this review is to synthesize the international evidence regarding the effectiveness of substance use prevention programs for Indigenous adolescents in the United States of America, Canada, Australia and New Zealand. Eight peer-reviewed databases will be searched, using search terms in line with the aims of this review and based on previous relevant reviews of substance use prevention. Studies will be included if they evaluate a substance use prevention program with Indigenous adolescents (aged 10 to 19) as the primary participant group and are published between 1 January 1990 and 31 August 2017. A narrative synthesis will be provided about the effectiveness of the programs, the type of program (whether cultural-based, adapted or unadapted), delivery of program (computer- and internet-delivered or traditional) and the setting in which the programs are delivered (community, school, family or a combination). The study will identify core elements of effective substance use prevention programs among Indigenous adolescents and appraise the methodological quality of the studies. This review will provide researchers, policy makers and program developers with evidence about the potential use of prevention approaches for Indigenous adolescents.
National Food, Nutrition and Physical Activity Survey of the Portuguese general population, 2015-2016: Design and methods
Date Submitted: Sep 18, 2017
Open Peer Review Period: Sep 20, 2017 - Oct 4, 2017
The National Food, Nutrition and Physical Activity Survey, 2015-2016 aimed to collect national and regional data on dietary habits and physical activity, and to evaluate their relation with health det...
The National Food, Nutrition and Physical Activity Survey, 2015-2016 aimed to collect national and regional data on dietary habits and physical activity, and to evaluate their relation with health determinants. Data were collected in a representative sample of the Portuguese general population (3 months to 84 years), by multistage sampling, and harmonized according to European guidelines/methodologies. An electronic platform was developed to manage the field work and to assist data collection by using Computer-assisted personal interviewing and includes the ‘eAT24’ module for dietary data collection by 24-hour recalls (two non-consecutive, 8-15 days apart) or food diaries in the case of children <10 years-old, synchronized with nutritional composition data and considering the FoodEx2 classification system; the ‘MOVE’ module for physical activity data (including the International Physical Activity Questionnaire, the Activity Choice Index, and 4-days physical activity diaries); and the ‘You’ module to collect sociodemographic and other health-related data. The results will assist policy planning and management of national health programs on the improvement of nutritional status and risk assessment related with food hazards, and the enhancement of physical activity. The infrastructures and data driven are a solid basis to the development of a future surveillance system reproducible over time.
Multicenter Study on the Burden of Illness of Oral Side Effects from Conditioning Therapy Before Stem Cell Transplantation “Ora-Stem Study”
Date Submitted: Sep 15, 2017
Open Peer Review Period: Sep 17, 2017 - Oct 1, 2017
Background: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of i...
Background: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of illness in the oral cavity from various cytotoxic therapies, it is difficult to produce evidence-based, preventive and management protocols. A prospective multicenter study is necessary to collect data on the burden of illness from various cytotoxic regimens. Objective: The objectives of this prospective international observational multicenter study in hematopoi-etic stem cell transplant (HSCT) patients are to establish the nature, incidence and temporal re-lationship of oral complications related to conditioning regimens (chemotherapy with or with-out total body irradiation-TBI), stem cell transplantation and the immunologic reactions (main-ly GVHD) that may follow, and to determine what subjective and objective oral complica-tions related to treatment can predict negative clinical and economic outcomes and reduced quality of life (QoL). Methods: Adult patients at six study sites receiving full intensity conditioning (FIC), reduced intensity conditioning (RIC) or non-myeloablative conditioning (NMA), followed by autologous or al-logeneic hematopoietic stem cell infusion, are included. A pre-treatment assessment includes medical conditions, planned chemo- and radiation therapy regimen, medications, allergies, so-cial history, patient report of oral problems, dental history, subjective oral complaints, objec-tive measures of oral conditions, current laboratory values, dental treatment recommended and untreated dental disease. Starting 1-3 days after hematopoietic stem cell infusion, a bedside assessment is completed 3 days/week until resolution of neutropenia. A patient questionnaire is also completed during hospitalization. Beyond this time, patients with continued oral mu-cositis or other oral problems are followed 1 day/week in an inpatient or outpatient setting. Additional visits for urgent care for acute oral problems after hospitalization are documented. Autologous transplant patients are being followed up at 100 days ±30 days and at 1 year ±30 days post-transplantation to identify any long-term side effects. Patients treated with alloge-neic transplantation are being followed at 100 days ±30 days, 6 months ±30 days, and 12 months ±30 days. The follow-up assessments include cancer response to therapy, current med-ical conditions, medications, subjective and objective oral findings, QoL measures and labora-tory values. Results: A total of 211 participants have been enrolled. We anticipate enrollment of 109 additional par-ticipants to obtain the sample size of 320. Conclusions: The results of the ongoing prospective study will provide a unique dataset to understand the impact of oral complications on patients undergoing HSCT and provide needed information with forming more evidence-based guidelines regarding the management of this patient co-hort.