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JMIR Research Protocols
Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
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Journal Description
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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Latest Submissions Open for Peer-Review:
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Simultaneous Digital Tracking of Physical Activity, Heart Rate, and Iloprost Inhalation in Patients with Pulmonary Arterial Hypertension: Design of the Observational VENTASTEP Study
Date Submitted: Sep 10, 2018
Open Peer Review Period: Sep 15, 2018 - Sep 29, 2018
Background: Patients with pulmonary arterial hypertension (PAH) – a progressive, ultimately fatal disease – often experience dyspnea which can limit their ability to perform everyday activities. I...
Background: Patients with pulmonary arterial hypertension (PAH) – a progressive, ultimately fatal disease – often experience dyspnea which can limit their ability to perform everyday activities. Iloprost is an inhaled therapy for PAH that has shown efficacy as monotherapy and when added to other PAH pharmacotherapies. However, clinical trials in PAH have provided only limited data on parameters reflecting the impact of the disease on daily life. Digital monitoring of daily physical activity in PAH is therefore attracting growing interest. To fully understand a patient’s response to treatment, monitoring of treatment adherence is also required. The recently approved Breelib™ nebulizer for administration of iloprost saves inhalation data, thus allowing digital monitoring of adherence. Objective: We aim to perform parallel digital tracking of physical activity parameters, heart rate, and iloprost inhalation data in patients with PAH before and after starting treatment with inhaled iloprost, to investigate the association between changes in digital measures and traditional clinical measures. Methods: VENTASTEP is a digital, prospective, observational, multicenter, single-arm cohort study of adult patients with PAH in Germany starting treatment with inhaled iloprost via the Breelib™ nebulizer on top of existing PAH therapy. The study comprises a baseline period without iloprost treatment (usually ≤ 1 week depending on factors such as nebulizer availability) and an observation period with iloprost treatment (3 months ± 2 weeks). The Apple Watch 2 and iPhone 6S are used with a dedicated study app to measure a range of digital physical activity parameters and heart rate continuously during the baseline and observation periods; the watch is also used with a 6-minute walking distance (6MWD) app to measure digital 6MWD at baseline and the end-of-observation visit. Inhalation frequency, completeness, and duration are monitored digitally via the nebulizer and the BreeConnect™ app. Changes in traditional outcome measures (6MWD, Borg dyspnea scale, EuroQol 5-dimensions questionnaire, functional class, and brain natriuretic peptide [BNP]/N-terminal pro-BNP) between baseline and the end-of-observation visit will be compared with changes in digital daily physical activity parameters and digital 6MWD as the primary analysis. Secondary endpoints include activity status (active, inactive and watch not worn), inhalation behavior, association of physical activity level with time since last inhalation, Pittsburgh Sleep Quality Index, heart rate, association of heart rate with device-based outcomes, and adverse events. Results: The first participant was enrolled in February 2018 (estimated study completion: July 2019; planned sample size: 80 patients). Conclusions: The VENTASTEP study will provide a wealth of data to inform future research on the utility of digital parameters as outcome assessment tools for disease monitoring and guidance of treatment in PAH. The study will also provide insight into clinical outcomes, physical activity, and quality of life in patients starting inhaled iloprost on top of existing PAH therapy. Clinical Trial: ClinicalTrials.gov NCT03293407; https://clinicaltrials.gov/ct2/show/NCT03293407 (Archived by WebCite at http://www.webcitation.org/6ywPGcn4I)
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Obesity and type 2 diabetes - Raising the issue of weight management in primary care (Small Talk Big Difference): protocol for a randomised controlled trial
Date Submitted: Sep 10, 2018
Open Peer Review Period: Sep 15, 2018 - Sep 29, 2018
Background: Guidelines for the management of type 2 diabetes universally recommends that adults with type 2 diabetes and obesity should be offered individualised interventions to encourage weight loss...
Background: Guidelines for the management of type 2 diabetes universally recommends that adults with type 2 diabetes and obesity should be offered individualised interventions to encourage weight loss. Yet despite the existing recommendations, provision of weight management services is currently patchy around the UK and where services are available, high attrition rates are often reported. In addition, individuals often fail to take-up services, that is, after discussion with a GP or practice nurse, individuals are referred to the service but do not attend for an appointment. Qualitative research has identified that the initial discussion raising the issue of weight, motivating the patient and referring to services is crucial to a successful outcome from weight management. Objective: To evaluate the effectiveness of an online training programme and practice implementation toolkit +/- face-to-face training for primary care staff. The primary outcome is the change in referral rate of patients with type 2 diabetes to NHS adult weight management programmes, 3 months prior to and post the intervention. Methods: We have used the Behaviour Change Wheel to develop an intervention for staff in primary care consisting of a 1-hour online eLearning package covering the links between obesity, T2DM and the benefits of weight loss, the treatment of diabetes in patients with obesity, specific training in raising the issue of weight, local services and referral pathways, overview of weight management components/ evidence base, and the role of the referrer; a patient leaflet; a discussion tool; a practice implementation checklist; and an optional 2.5-hour face-to-face training session. A total of 100 practices have been randomly assigned in a 1:1 ratio to either have immediate access to all the resources, or have access delayed for 4 months. An intention to treat statistical analysis will be performed. Results: Having fully recruited, this study will finalise follow-up in 2018 and publish in early 2019. Conclusions: This protocol describes the development, and randomised evaluation of the effectiveness, of an intervention to improve referral and uptake rates of weight management programmes for adults with type 2 diabetes. At a time when many new dietary and pharmacological weight loss interventions are showing large clinical benefits for people with type 2 diabetes, it is vital that primary care practitioners are willing, skilled and able to discuss weight and make appropriate referrals to services. Clinical Trial: ClinicalTrials.gov NCT03360058, https://clinicaltrials.gov/ct2/show/NCT03360058
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SOVA: a social media website to support treatment uptake for adolescents with depression and/or anxiety and their parents: Protocol for a Pilot Randomized Controlled Trial
Date Submitted: Sep 7, 2018
Open Peer Review Period: Sep 12, 2018 - Sep 26, 2018
Background: Few adolescents who experience depression or anxiety connect to mental health treatment. SOVA (Supporting Our Valued Adolescents) is a stakeholder-informed technology intervention which co...
Background: Few adolescents who experience depression or anxiety connect to mental health treatment. SOVA (Supporting Our Valued Adolescents) is a stakeholder-informed technology intervention which consists of two interactive websites, one for adolescents and one for parents. SOVA is designed to intervene on targets which may increase mental health treatment uptake when adolescents with depression or anxiety are identified in primary care settings. Objective: To describe the protocol for a pilot randomized controlled trial designed to refine recruitment and retention strategies, document intervention fidelity and implementation outcomes, and assess changes in health beliefs and knowledge, emotional/informational support, and parent-adolescent communication quality in adolescents and their parents. Methods: Adolescents identified with symptoms of depression or anxiety for which a healthcare provider recommends treatment and their parents will be recruited from an adolescent and young adult medicine clinic which provides primary and consultative care. Adolescent-parent dyads will be randomized 1:1 to both receive the SOVA websites and enhanced usual care or to enhanced usual care alone. Baseline measures and 6-week and 3-month outcomes will be collected by online self-report surveys and electronic health record review. The main outcome is 6-week study retention rate. Analyses will also assess changes in health beliefs and knowledge, emotional support, and parent-adolescent communication in both adolescents and their parents. Results: Recruitment commenced in April 2018. Conclusions: The findings of this research will inform design of a multi-site hybrid effectiveness-implementation RCT examining the effectiveness and optimal implementation strategies for use of SOVA in community primary care settings. Clinical Trial: ClinicalTrials.gov NCT03318666 ; https://clinicaltrials.gov/ct2/show/NCT03318666
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Design and rationale of a prospective, observational, multicenter cohort study on biological and functional changes in adult healthy smokers who are continuously abstinent from smoking for one year
Date Submitted: Sep 7, 2018
Open Peer Review Period: Sep 12, 2018 - Sep 26, 2018
Background: The harm of cigarette smoking results mainly from long-term exposure to harmful and potentially harmful constituents (HPHC) generated by the combustion of tobacco. Smoking cessation (SC) e...
Background: The harm of cigarette smoking results mainly from long-term exposure to harmful and potentially harmful constituents (HPHC) generated by the combustion of tobacco. Smoking cessation (SC) engenders favorable changes of clinical signs, pathomechanisms, and metabolic processes that together could reduce the harm and risk of smoking-related diseases to a relative risk level approximating that of never-smokers over time. In most SC studies, the main focus is on the successful quitting rate of the SC program being tested. As limited information on short- to multiple long-term functional/biological changes following SC is available in the literature, more data on short to mid-term favorable impacts of SC are needed. Objective: The overall study aim was to assess the reversibility of the harm related to smoking over one year of continuous smoking abstinence (SA). This has been verified by assessing a set of biomarkers of exposure (BoExp) to HPHCs and a set of clinical risk endpoints (CRE) indicative of multiple pathophysiological pathways underlying the development of smoking-related diseases. Methods: This multiregional (United States, Japan, Europe), multicenter (42 sites) cohort study consisting of a one-year SA period in an ambulatory setting and a 28-day safety follow-up period was conducted from May 2015 to May 2017. A total of 1,184 male and female adult healthy smokers, willing to quit smoking, were enrolled in the study. Nicotine replacement therapy (NRT) was provided for up to three months upon subject’s request, and SC counseling and behavioral support were continuously provided. BoExp to HPHCs and CREs were assessed in urine and blood at baseline, Month 3, Month 6, and Month 12. Cardiovascular CREs included parameters reflecting inflammation (white blood cell), lipid metabolism (high-density lipoprotein cholesterol), endothelial function (soluble intercellular adhesion molecule-1), platelet function (11-dehydrothromboxane B2), oxidative stress (8-epi-prostaglandin F2 alpha) and carbon monoxide exposure (carboxyhemoglobin). Respiratory CREs included lung function parameters and cough symptoms. The CREs to evaluate genotoxicity (total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and xenobiotic metabolism (cytochrome P450 2A6 activity) were also assessed. Continuous SA was verified at each visit following the actual quit date using cigarette self-reporting and chemical verification. Safety assessments included adverse events/serious adverse events, body weight, vital signs, spirometry, electrocardiogram, clinical chemistry, hematology and urine analysis safety panel, physical examination, and concomitant medications. Results: In total, 1,184 subjects (50.1% male) were enrolled; 30% of them quit smoking successfully for one year. Data analyses of the study results (including safety data) are ongoing and will be published after study completion. Conclusions: The current study provides insights into biological and functional changes, and health effects, after continuous SA over one year. Study results will be instrumental in assessing novel alternative products to cigarettes considered for tobacco harm reduction strategies. Clinical Trial: ClinicalTrials.gov identifier: NCT02432729
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Transforming mental health delivery through behavioral economics and implementation science: A project protocol
Date Submitted: Sep 5, 2018
Open Peer Review Period: Sep 10, 2018 - Sep 24, 2018
Background: Efficacious psychiatric treatments are not consistently deployed in community practice and clinical outcomes are attenuated compared with those achieved in clinical trials. A major focus f...
Background: Efficacious psychiatric treatments are not consistently deployed in community practice and clinical outcomes are attenuated compared with those achieved in clinical trials. A major focus for mental health services research is to develop effective and cost-effective strategies that increase the use of evidence-based assessment, prevention, and treatment approaches in community settings Objective: The goal of this program of research is to apply insights from behavioral economics and participatory design to advance the science and practice of implementing evidence-based practice for individuals with psychiatric disorders across the lifespan. Methods: Project 1 (Assisting Depressed Adults in Primary care Treatment; ADAPT) is patient-focused and leverages decision-making heuristics to compare ways to incentivize adherence to anti-depressant medications in the first six weeks of treatment among adults newly diagnosed with depression. Project 2 (App for Strengthening Services In Specialized Therapeutic Support; ASSISTS) is provider-focused and utilizes normative pressure and social status to increase data collection among community mental health workers treating children with autism. Project 3 (Motivating Outpatient Therapists to Implement: Valuing a Team Effort; MOTIVATE) explores how participatory design can be used to design organizational-level implementation strategies to increase clinician use of evidence-base practices. The projects are supported by a Methods Core that provides expertise in implementation science, behavioral economics, participatory design, measurement, and associated statistical approaches. Discussion: This research will advance the science of implementation through efforts to improve implementation strategy design, measurement, and statistical methods. First, we will test and refine approaches to collaboratively designing implementation strategies with stakeholders (e.g., discrete choice experiments; innovation tournaments). Second, we will refine measurement of mechanisms related to heuristics used in decision-making. Third, we will develop new ways to test mechanisms in multilevel implementation trials. This trifecta, coupled with findings from our three exploratory projects, will lead to improvements in our knowledge of what causes successful implementation, what variables moderate and mediate the effects of those causal factors, and how best to leverage this knowledge to increase the quality of care for people with psychiatric disorders. Trial registration: Clinicaltrials.gov NCT03441399. Registered 15 February 2018. https://www.clinicaltrials.gov/ct2/show/NCT03441399?term=marcus%2C+steven&rank=2.
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Safety of Intranasal Ketamine for Reducing Uncontrolled Cancer Related Pain
Date Submitted: Sep 5, 2018
Open Peer Review Period: Sep 10, 2018 - Sep 24, 2018
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Background: There are about 11.9 million Americans affected with cancer; of these, 53% of patients with cancer experience pain at all stages of cancer. Patients with cancer pain often require high dos...
Background: There are about 11.9 million Americans affected with cancer; of these, 53% of patients with cancer experience pain at all stages of cancer. Patients with cancer pain often require high dosages of opioids that can cause significant sedation. Occasionally, even after high dose opioid therapy, their pain remains uncontrolled in the setting of opioid tolerance or opioid unresponsive pain. Ketamine is an FDA approved anesthetic with amnesic, analgesic, dissociative, and sedative properties. Subanesthestic doses of ketamine have minimal adverse impact upon cardiovascular or respiratory function, but produce analgesia and modulate central sensitization, hyperalgesia, and opioid tolerance. Ketamine is typically administered intravenously (IV), but the IV route is not convenient for use in an ambulatory setting. Ketamine oral bioavailability is low due to hepatic first pass effect, limiting the application of this route for chronic use. The intranasal (NAS) route has several advantages, such as avoidance of first-pass hepatic metabolism, no need for venous access, ability to repeat doses quickly, and rapid absorption. There are limited data regarding the use of ketamine as an adjuvant to opioids for the management of cancer pain. Objective: We seek to obtain preliminary data on safety, feasibility, and utility of this novel technique for the treatment of uncontrolled cancer pain. Methods: A total of 10 adults with uncontrolled cancer related pain from the supportive oncology clinic, oncology clinics, the pain clinic, and the acute pain service at Emory University Hospital in Atlanta, GA will be enrolled in the study. All patients will be assigned to the same and only investigational treatment arm. Escalating doses of NAS ketamine will be given over 4 study visits (10mg, 30mg, 50mg). Patients will receive 10mg IV ketamine on visit 2 to serve as a control. They will be monitored for 240min after treatment. Pain, side effects, and related symptoms will be assessed using standardized assessment scales throughout each visit. Pharmacokinetics will be determined by drawing serial blood samples at each visit. Results: This trial has been funded by the Emory University Department of Anesthesiology, and is supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number ULTR002378 and KL2TR002381. IND receipt obtained 12/21/16 (IND133570). Approval by the Emory University institutional review board obtained 4/2/2017 (IRB 00086610). The study start date is 7/25/17 and estimated completion date is 7/1/19. Recruitment started in July 2017. Conclusions: This is a Phase I/II clinical trial meant to obtain preliminary data on the safety, feasibility, and utility of intranasal ketamine for the treatment of uncontrolled cancer related pain. Clinical Trial: ClinicalTrials.gov ID: NCT03146806
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