JMIR Research Protocols

Ongoing trials, grant proposals, and methods

Editor-in-Chief:

Gunther Eysenbach, MD, MPH, FACMI


 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed- and (new!) Scopus-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.

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 (preliminary results from pilot studies, early results, and formative research should now be published in JMIR Formative Research).

While the original focus was on the design of medical and health-related research and technology innovations, JRP publishes research protocols, proposals, feasibility studies, methods and early results in all areas of medical and health research.

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 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 proposals 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"!

 

Recent Articles

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RCTs - Protocols/Proposals (non-eHealth)

Augmented mindfulness-based cognitive therapy (MBCT) with treatment as usual (mainly pharmacotherapy) is reported to be effective after treatment for anxiety disorders. However, whether its effectiveness persists in the long term is unclear.

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Systematic Review Protocols

Obesity is a complex health condition with multiple associated comorbidities and increased economic costs. People from low socioeconomic status (SES) backgrounds are more likely to be overweight and obese and are less successful in traditional weight management programs. It is possible that eHealth interventions may be more successful in reaching people from low SES groups than traditional face-to-face models, by overcoming certain barriers associated with traditional interventions. It is not yet known, however, if eHealth weight management interventions are effective in people living with overweight and obesity from a low SES background.

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RCTs - Protocols/Proposals (funded, already peer-reviewed, non-eHealth)

Depression is a substantial health and economic burden. In approximately one-third of patients, depression is resistant to first-line treatment; therefore, it is essential to find alternative treatments. Transcranial magnetic stimulation (TMS) is a neuromodulatory treatment involving the application of magnetic pulses to the brain that is approved in the United Kingdom and the United States in treatment-resistant depression. This trial aims to compare the clinical effectiveness, cost-effectiveness, and mechanism of action of standard treatment repetitive TMS (rTMS) targeted at the F3 electroencephalogram site with a newer treatment—a type of TMS called theta burst stimulation (TBS) targeted based on measures of functional brain connectivity. This protocol outlines brain imaging acquisition and analysis for the Brain Imaging Guided Transcranial Magnetic Stimulation in Depression (BRIGhTMIND) study trial that is used to create personalized TMS targets and answer the proposed mechanistic hypotheses.

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Non-Randomized Study Protocols and Methods (Non-eHealth)

Infectious intestinal disease (IID) is common, and children are more likely than adults both to have IID and to transmit infection onto others. Before the introduction of the vaccine, rotavirus was the leading cause of severe childhood diarrhea, with norovirus and Campylobacter predominate pathogens. Public health surveillance of IID is primarily based on health care data, and as such, illness that is managed within the community will often go undetected. School attendance registers offer a novel data set that has the potential to identify community cases and outbreaks of IID that would otherwise be missed by current health surveillance systems. Although studies have explored the role of school attendance registers in the monitoring of influenza among children, no studies have been identified that consider this approach in the surveillance of IID.

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Grant Proposals (eHealth, funded)

Virtual Health and Wellbeing Living Lab Infrastructure is a Horizon 2020 project that aims to harmonize Living Lab procedures and facilitate access to European health and well-being research infrastructures. In this context, this study presents a joint research activity that will be conducted within Virtual Health and Wellbeing Living Lab Infrastructure in the transitional care domain to test and validate the harmonized Living Lab procedures and infrastructures. The collection of data from various sources (information and communications technology and clinical and patient-reported outcome measures) demonstrated the capacity to assess risk and support decisions during care transitions, but there is no harmonized way of combining this information.

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Non-randomized Protocols and Methods (ehealth)

As SARS-CoV-2, the virus that causes COVID-19, spread rapidly across the United States in the spring of 2020, institutions of higher education faced numerous challenges associated with minimizing risk of exposure to COVID-19 among their students, faculty, staff, and surrounding communities. This paper describes the protocol, South Carolina (SC) Safer Together, developed by Clemson University (Clemson) to design, deploy, and evaluate multi-level communication and dissemination and implementation (D&I) strategies in line with recommendations from governmental and educational agencies to mitigate the risk of exposure to COVID-19. Safer Together was enhanced by the addition of the Google/Apple Exposure Notification app, an alternative strategy to support a recommendation of COVID-19 testing outcomes: contact tracing, isolation, and quarantine.

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Scoping Review Protocols

Many health conditions can be prevented, managed, or improved through behavioral interventions. As a component of health behavior change interventions, biological feedback is of particular interest given recent advances in wearable biosensing technology, digital health apps, and personalized health and wellness. Nevertheless, there is a paucity of literature to guide the design and implementation of interventions that incorporate biological feedback to motivate health behavior change.

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RCTs - Protocols/Proposals (funded, already peer-reviewed, non-eHealth)

The increasing rate of mental health issues among adolescents has recently been a considerable concern in Hong Kong. In particular, adolescents with low socioeconomic status (SES) are likely to experience poor mental health, including low self-esteem and high levels of anxiety, anger, and depression. Previous research has found that physical activities have a positive impact on improving mental health outcomes among adolescents. However, approximately 96% of adolescents in Hong Kong do not engage in regular exercise, which potentially increases the risk of poor mental health.

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RCTs - Protocols/Proposals (non-eHealth)

Although it is widely acknowledged that food intake can worsen symptoms in patients with irritable bowel syndrome (IBS), there is a lack of efficient treatments that can apply to all patients and subtypes of IBS. As IBS can manifest in different ways, it is likely that the most successful treatment option will differ among patients; therefore, this large, randomized controlled trial comparing 3 different treatment options for patients with IBS is highly warranted.

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RCTs - Protocols/Proposals (non-eHealth)

Major depressive disorder is among the most disabling illnesses worldwide, with a lifetime prevalence of 16.2%. Research suggests that 20% to 40% of patients with depression do not respond to pharmacotherapy, developing treatment-resistant depression. Electroconvulsive therapy is the gold standard for treating individuals with treatment-resistant depression, with remission rates of approximately 75% to 90%. However, 10% to 25% of patients do not respond to electroconvulsive therapy, and many are unable to tolerate it due to the side effects. Both groups are considered to be patients who do not respond to electroconvulsive therapy, because both groups continue to exhibit symptoms of severe depression, have a limited number of treatment options available, and are in need of rapid treatment. Ketamine, an N-methyl-D-aspartate receptor antagonist, has been shown to exert rapid antidepressant effects in patients with treatment-resistant depression when administered in subanesthetic doses through 40-minute intravenous infusions. Recently, a ketamine compound, esketamine (Spravato), that is administered through the intranasal route received regulatory approval by the US Food and Drug Administration and Health Canada to treat depression. However, esketamine is challenging to access due to high costs and limited availability. Racemic ketamine (rketamine) is cheap and easy to access; however, the effects in patients who have not responded to electroconvulsive therapy have yet to be understood or tested. This study will use transcranial magnetic stimulation to study mechanisms of human brain cortical physiology at the systemic level to identify neurobiomarkers of response.

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Preprints Open for Peer-Review

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