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: 4.7)
- 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
ActiviTeen: A Protocol for Deployment of Consumer Wearable Devices in Schools
Date Submitted: May 3, 2016
Open Peer Review Period: May 4, 2016 - May 18, 2016
Background: Consumer wearables, such as Fitbit or Jawbone, are becoming increasing popular to track physical activity. With the increased adoption of activity trackers comes the increased generation...
Background: Consumer wearables, such as Fitbit or Jawbone, are becoming increasing popular to track physical activity. With the increased adoption of activity trackers comes the increased generation of valuable individual-based data. Generated data has the potential to provide detailed insights into the user’s behavior and lifestyle. Objective: The primary objective of the described study is to evaluate the feasibility of individual data collection from the selected consumer wearable device (the Fitbit Zip™). The rate of user attrition and barriers preventing the use of consumer wearable devices will also be evaluated as secondary objectives. Methods: The pilot study will occur in two stages and employ a longitudinal analysis with a convenience sample of 30 students attending Research Triangle High School. For the first stage, students will initially be asked to wear the Fitbit Zip™ over the course of four weeks. During which time, their activity data and step count will be collected. Students will also be asked to complete a self-administered survey at the beginning and conclusion of the first stage. The second stage will continue to collect student’s activity data and step count over an additional three month period. Results: We are anticipating results for this study by the end of 2016. Conclusions: This study will provide insight into the data collection procedures surrounding consumer wearable devices and could serve as the future foundation for other studies deploying consumer wearable devices in educational settings.
Impact on outcome of mandatory insulin therapy in critically ill patients: the PERMIT study (mandatory insulin therapy versus usual care insulin therapy in the intensive care unit): protocol for a randomised controlled trial
Date Submitted: Apr 28, 2016
Open Peer Review Period: Apr 29, 2016 - May 13, 2016
Background: Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advanta...
Background: Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advantage or reduces complication rates. Policies of “tight” glycaemic control was rapidly adopted by many general ICUs worldwide in the mid 00’s, even though the results of the study were not generalisable to mixed medical/surgical ICUs with different intravenous feeding policies. Objective: The primary objective of the study is to assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting. Methods: This protocol summarizes the rationale and design of a randomised, controlled single centre trial investigating the effect of mandatory insulin therapy versus usual care insulin therapy for those patients admitted for a stay of longer than 48 hours. In total, 109 critically ill adults predicted to stay in intensive care for longer than 48 hours were consented. The primary outcome is to determine the safety of mandatory insulin therapy in critically ill patients using the number of episodes of hypoglycaemia per unit length of stay in intensive care. Secondary outcomes include duration of mechanical ventilation, duration of ICU and hospital stay, hospital mortality, and measures or renal, hepatic and haematological dysfunction. The primary analysis will be intention to treat. Recruitment started in July 2005 and completed in April 2007. Results: This protocol for a randomised controlled trial investigating the effect of mandatory insulin therapy should provide an answer to a key question for the management of patients in the intensive care unit and ultimately improving outcome. Conclusions: This is a trial protocol document. Clinical Trial: ISRCTN005504641
Predictors of vascular cognitive impairment post stroke in a Middle Eastern (Bahrain) cohort: A case-control proposed comparison.
Date Submitted: Apr 25, 2016
Open Peer Review Period: Apr 28, 2016 - May 12, 2016
Background: Post stroke dementia and cognitive impairment are associated with poor long-term outcomes, including survival and disability after stroke. The contribution of genetic factors such as the p...
Background: Post stroke dementia and cognitive impairment are associated with poor long-term outcomes, including survival and disability after stroke. The contribution of genetic factors such as the presence of ApoE ɛ4 allele and its association with cognitive impairment post stroke remains inconclusive, particularly in Middle Eastern regions. Objective: The aim of this study is to examine correlates and potential predictors of cognitive impairment, including biomarkers, in stroke patients and compare these functions to healthy older adults in a Middle Eastern cohort. Methods: A prospective stroke sample of n=200 patients (case group) and n=100 healthy ageing individuals (control group) will be recruited from the largest medical complex in Bahrain. A neuropsychological battery of cognitive assessments (global, executive and metacognition) will be conducted on all participants. Participants will be categorized into four sub-groups (non-vascular cognitive impairment, vascular cognitive impairment with no dementia, vascular dementia and mixed dementia) using standardised cognitive assessment scores and the DSM-IV dementia criteria. Biomarkers will include ApoE genotype, sRAGE, NEP, BACE1, biochemistry and haematology measurements. Results: The primary study outcome is to determine early risk factors for cognitive impairment after stroke in a Bahraini cohort. The study has received full ethical approval from the Bahrain Ministry of Health and from the affiliated university. Conclusions: With increasing stroke incidence rates in the Middle East, this research study will provide useful biological and epidemiological data for future development and planning of health policies and guidelines for stroke care within the Gulf region. Clinical Trial: Not a clinical trial - a research study proposal
FacharztPlus*: Securing the continuity of medical com-petence in times of demographic change
Date Submitted: Apr 22, 2016
Open Peer Review Period: Apr 28, 2016 - May 12, 2016
Background: University hospitals make up the backbone of medical and economic services of hospitals in Germany: They qualify specialist physicians, ensure medical research and provide highly specializ...
Background: University hospitals make up the backbone of medical and economic services of hospitals in Germany: They qualify specialist physicians, ensure medical research and provide highly specialized maximum medical care, which other hospitals can-not undertake (e.g. in transplantation, neurology and cardiology). This three-fold assignment must be managed despite a growing shortage of specialist physicians: Today, there are approximately 7,000 open positions for physicians; by the year 2020, the replacement for retired physicians and increased demand will total 30,000 positions. The job of a specialist physician in a university hospital demands a high workload, which makes it difficult to combine both family and career with personal flexibility. The situation will become more difficult because on the whole patients are becoming older and sicker and because specialist physicians are able to find more attractive working conditions in smaller hospitals, abroad or outside of curative medicine. Objective: A change of university hospitals towards retaining medical specialists with long-term career and work perspectives has begun, but is neither fast, nor sustainable enough to cope with the increasing challenges: Over 70% of the medical students are women, and according to forecasts, over 10,000 new part time positions need to be created for specialist physicians by 2019. In order to retain sufficient qualified employees, major improvements in quality are required in terms of working and training conditions. For this purpose, a sustainable innovation process is necessary which incorporates solutions from outside of the health care sector in order to be able to learn from experiences and mistakes from other industries. Methods: The project FacharztPlus aims to find suitable measures in order to retain specialist physicians for some more years after completion of five years of professional training. This should determine the suitability of additional qualifications alongside the professional career and an expertise-related work organization oriented to dif-ferent stages of life. A long-term perspective after professional training is not just attractive for retaining, but also for recruiting specialists. To achieve this, compari-sons with other industries are being made and effective, practical solution concepts will be developed. The measures, methods and instruments included in the solutions are assessed according to their transferability, then, after detailed imple-mentation planning, are developed into especially promising measures. These measures are implemented in the Department of Anesthesiology, Intensive Care and Pain Medicine at the University Hospital Muenster (Germany), University of Muenster (UKM) with approximately 150 physicians, of which 60 possess specialist physician qualifications as well as the University Hospitals in Aachen, Rostock, and Greifswald and in the further 44 departments of the UKM with the associated 9,000 employees and presented to the 22 teaching hospitals. Finally, the measures are then also utilized in professional associations, chambers and at congresses. Results: work in progress Conclusions: work in progress Clinical Trial: n/a
Advancing Interprofessional Primary Health Care Services in Rural Settings for People with Chronic Low Back Disorders: Protocol of a Community-Based Randomized Controlled Trial
Date Submitted: Apr 27, 2016
Open Peer Review Period: Apr 28, 2016 - May 12, 2016
Background: Chronic low back disorders (CLBD) are a substantial burden on individuals and societies impacting up to 20% of Canadians. Rural and remote residents are approximately 30% more likely to ha...
Background: Chronic low back disorders (CLBD) are a substantial burden on individuals and societies impacting up to 20% of Canadians. Rural and remote residents are approximately 30% more likely to have CLBD. Reduced access to appropriate team-based health services, including physical therapy, is a key factor that may magnify the impact of CLBD on pain, physical function, overall quality of life, and health-related system and individual costs. Objective: The purpose of this project is to evaluate the validity, comparative effectiveness, and costs of an interprofessional management approach for people with CLBD delivered through telehealth. Methods: Three different health care delivery options in a rural Saskatchewan community with limited physical therapy services will be compared through a community-based randomized controlled trial: 1) usual care delivered by a local rural nurse practitioner (NP); 2) a new videoconferencing/ telehealth option connecting an urban-based physical therapist (PT) with a local NP; and 3) face-to-face services by a PT traveling to the community. Patient reported outcomes of pain, physical function, quality of life, satisfaction, and CLBD-care related costs will be evaluated up to 6 months after the intervention. Patient and provider experiences with the team telehealth approach will be explored through qualitative interviews. Validity of the new team care model will be explored through comparing the concordance of diagnosis and management recommendations arising from of a separate group of participants with CLBD. Results: The study was funded in July 2013 and ethics was approved in November 2013. Participant recruitment began in September 2014 and data collection was complete in December 2015. Results are anticipated in September 2016. Conclusions: CLBD is a widespread public health problem, more so in rural and remote areas, which require new innovative approaches to appropriate health care delivery. This study will provide evidence and guidance of interventions that have the potential to improve efficiency, coordination, and continuity to ensure that health needs are met in the right place, at the right time, by the appropriate care provider(s). Clinical Trial: ClinicalTrials.gov Identifier: NCT02225535; url: https://clinicaltrials.gov/ct2/show/NCT02225535