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Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed-indexed journal, publishing 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 journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (JMIR Impact Factor 2017: 4.671).
While the original focus was on eHealth studies, JMIR Res Protoc now 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.
JRP is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?.
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 provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.
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).
JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).
Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!
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Background: Current evidence shows that bariatric surgery and especially Roux-en-Y Gastric Bypass (RYGB) is the best treatment for obesity and its complications including type 2 diabetes (T2DM). Under...
Background: Current evidence shows that bariatric surgery and especially Roux-en-Y Gastric Bypass (RYGB) is the best treatment for obesity and its complications including type 2 diabetes (T2DM). Understanding the specific mechanisms responsible for the beneficial metabolic effects will help to engineer ways to improve the procedure or produce these effects without surgery. Objective: The focus of this report is a translational study, designed to test a hypothesis for the mechanisms underlying the improvement in T2DM following gastric bypass that involves specific changes in the post-surgical, short- and long-term metabolism and morphology of the jejunum (Roux limb). Specifically to test whether the intestine enhances its metabolism and activity after gastric bypass and increases its fuel utilization, we designed a prospective, longitudinal study, which involved the recruitment of bariatric bypass surgery candidates with and without T2DM. We describe the tissue bank that we have generated and we discuss in detail our experience, hoping to further facilitate the performance of longitudinal mechanistic studies in human patients undergoing bariatric surgery and especially those involving methods examining the post-bypass intestinal biology. Methods: We designed and conducted a clinical trial (clinicaltrials.gov ID NCT02710370) aiming to characterize the effects of RYGB on intestinal metabolism. Intestinal tissue samples were collected from the jejunum at surgery, 1, 6, and 12 months post operatively for analysis of intestinal gene expression, metabolomic and morphologic changes. The target number of patients with completed at least the 6-month follow up was 26 and we included a 20% attrition rate increasing the total number to 32. Results: To enroll 26 patients, we had to approach 79 potential participants. 37 agreed to participate and started the study. 33 active participants completed their 1 month, 30 their 6 month and 26 their 12 month studies. Three participants withdrew and 30 participants are still active. Altruism and interest in research were the most common reasons for participation. Important factors for feasibility and successful retention included: 1) large volume case flow, 2) inclusion and exclusion criteria broad enough to capture a large segment of the patient population, but narrow enough to ensure completing study aims and protecting safety concerns, 3) accurate assessment of willingness and motivation to participate in a study, 4) seamless integration of the recruitment process into normal clinical flow, 5) financial reimbursement and non-financial rewards and gestures of appreciation and 6) non-burdensome follow-up visits and measures and reasonable time allotted. Conclusions: Human translational studies of the intestinal mechanisms of metabolic and weight change after bariatric surgery are both important and feasible. A tissue bank with unique samples has been established that could be used by investigators in many research fields further enabling mechanistic studies on the effects of bariatric surgery. Clinical Trial: Clinicaltrials.gov ID NCT02710370
BACKGROUND: Sleep disruptions are common during pregnancy, and associated with increased risk for adverse maternal outcomes such as pre-eclampsia, gestational diabetes, prolonged labor, and cesarean b...
BACKGROUND: Sleep disruptions are common during pregnancy, and associated with increased risk for adverse maternal outcomes such as pre-eclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitoring (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown. OBJECTIVE: To describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability and preliminary efficacy of using a PHM device (Misfit Shine 2) to promote sleep during pregnancy. METHODS: The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at 1:1 ratio into a 12-week sleep education plus PHM device or sleep education alone comparison group. The primary outcomes will be measures of feasibility (i.e., recruitment, enrollment, adherence) and acceptability (i.e., participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, depressive symptoms, and birth outcomes (e.g., delivery methods). DISCUSSION: This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions as they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women.
Background: There is a growing understanding that wellbeing and mental illness are two separate dimensions of mental health. Positive mental health is associated with decreased risk of disease and men...
Background: There is a growing understanding that wellbeing and mental illness are two separate dimensions of mental health. Positive mental health is associated with decreased risk of disease and mental illness and increased longevity. Objective: This randomized controlled trial aims to test the efficacy of a mobile phone based intervention on positive mental health. Methods: Two-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (e.g. university websites). Participants will be randomly allocated to either an intervention (fully automated mobile-phone based mental health intervention) or control group (treatment as usual). The Primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form, MHC-SF). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale), emotional well-being, psychological functioning and social well-being (MHC-SF). Outcomes will be investigated at baseline, at 3- 6- and 12 months follow-up. Mediators (positive emotions and cognitions) will be investigated at baseline, mid-intervention and at 3 months follow-up using two single face-valid items. Results: Recruitment of participants will begin in mid-October 2018. Discussion: This study will add knowledge to the efficacy of a fully automated positive psychology intervention. Strengths and limitations of the study are discussed.
Background Adopting an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes render mixed resu...
Background Adopting an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes render mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population’s specific needs. The online intervention ‘MyPlan 2.0’ targets physical activity and sedentary behaviour in adults with type 2 diabetes. ‘MyPlan 2.0’ is grounded in self-regulation theory and, by incorporating the feedback of users with type 2 diabetes, iteratively adapted to its target population. Objective The goal of this paper is to thoroughly describe ‘MyPlan 2.0’ and the study protocol that will be used to test the effectiveness of this intervention to alter patients’ levels of physical activity and sedentary behaviour. Methods A superiority two-arm randomized controlled trial will be performed. Physical activity and sedentary behaviour will be measured via accelerometers and questionnaires. Furthermore, via questionnaires and diaries patients’ stressors and personal determinants for change will be explored in-depth. To evaluate the primary outcomes of the intervention multilevel analyses will be conducted. Conclusions This study will increase our understanding about whether and how a theory-based online intervention can help adults with type 2 diabetes to increase their level of physical activity and decrease their sedentary time.
Background: Depression is an often under-diagnosed and therefore untreated comorbidity for low-income, racially or ethnically diverse patients with a chronic illness such as diabetes. Recent update of...
Background: Depression is an often under-diagnosed and therefore untreated comorbidity for low-income, racially or ethnically diverse patients with a chronic illness such as diabetes. Recent update of the U.S. Preventive Services Task Force guideline in 2016 recommends assessing depression for every adult. Short Message Service (SMS) is an inexpensive, private, and scalable approach to provide depression screening and monitoring, and it can alleviate many barriers such as transportation, childcare, and clinical visit time faced by low-income population to receive depression diagnosis. Current evidence is inconsistent in comparing technology-mediated assessment vs. interviewer (INTW) assessment in collecting sensitive health information, as some studies suggest technology encourages self-disclosure while the other studies show the opposite effect. Objective: The proposed study will test using SMS to assess depression and its related conditions, including functional disability, pain, and anxiety, in low-income, culturally diverse safety-net primary care populations with diabetes. The study will examine the concordance between SMS and INTW assessments and evaluate test-retest reliability. Methods: The proposed study is a randomized trial with 200 patients with four study groups: SMS/INTW, INTW/SMS, SMS/SMS, INTW/INTW. The first two groups will be used to examine the concordance between SMS and INTW assessments. The third and fourth groups will be used to evaluate test-retest reliability. Participants of the study will be recruited from the participants of the prior Diabetes-depression Care-management Trial, a large comparative effectiveness research in collaboration with the Los Angeles County Department of Health Services (LAC-DHS). Concordance between SMS and INTW assessments will be evaluated by interclass correlation coefficient and Kappa statistic. Test-retest reliability will be measured by Cronbach’s alpha. Missing data patterns will be explored to understand whether participants are willing to self-disclose such information in SMS assessment. Results: Recruitment of participants was conducted from June, 2017 to November, 2017. A total of 206 participants were enrolled: 52 in SMS/INTW, 53 in SMS/SMS, 49 in INTW/SMS, 52 in INTW/INTW. Average age of the participants was 57.1. 57.8% (119/206) were female. 93.2% (192/206) were Latinos. And, 77.7% (160/206) chose Spanish as their preferred language. Test of the SMS assessment shows the cost of distributing the 16 questions is about $0.50 per person per time. Full results of the study will be reported elsewhere. Conclusions: The study is anticipated to establish feasibility of using SMS to assess depression and its related conditions in low-income, culturally diverse safety-net primary care populations with diabetes. We also expect to generate knowledge about whether patients in the targeted population are willing to reply and self-disclose the sensitive information about depression and its related conditions through SMS assessments.
Background: The United States (US) Centers for Disease Control and Prevention (CDC) estimates that approximately 60,000 US youth are living with Human Immunodeficiency Virus (HIV). US youth living wit...
Background: The United States (US) Centers for Disease Control and Prevention (CDC) estimates that approximately 60,000 US youth are living with Human Immunodeficiency Virus (HIV). US youth living with HIV (YLWH) have poorer outcomes compared to adults . With Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) support, new trials of youth-centered interventions to improve retention in care and medication adherence among YLWH are underway. Objective: Our objective is to use a computer simulation model, the Cost-effectiveness of Preventing AIDS Complications (CEPAC) - Adolescent Model, to evaluate selected ongoing and forthcoming ATN interventions to improve viral load suppression among YLWH and to define the benchmarks for uptake, effectiveness, durability of effect, and cost that will make these interventions clinically beneficial and cost-effective. Methods: This protocol, ATN 161, establishes the ATN Modeling Core. The Modeling Core leverages extensive data - already collected by successfully completed National Institute of Health (NIH)-supported studies - to develop novel approaches for modeling critical components of HIV disease and care in YLWH. As new data emerge from ATN trials during the award period about the effectiveness of these interventions, the CEPAC-Adolescent simulation model will serve as a flexible tool to project their long-term clinical impact and cost-effectiveness. The Modeling Core will derive model data input parameters and create model structure to reflect key aspects of HIV acquisition, progression, and treatment in YLWH. The ATN Modeling Core Steering Committee, with guidance from ATN leadership and scientific experts, will select model-based analyses to prioritize, as well as provide feedback on derivation of model input parameters and model assumptions. Project-specific teams will help frame research questions for model-based analyses, as well as provide feedback regarding project specific inputs, results, sensitivity analyses and policy conclusions. Results: N/A Conclusions: The ATN Modeling Core will provide critical information to guide the scale-up of ATN interventions and the translation of ATN data into policy recommendations for YLWH in the United States.