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
Nutrition UP 65 - Nutritional strategies facing an older demography: study methods
Date Submitted: May 27, 2016
Open Peer Review Period: May 27, 2016 - Jun 10, 2016
Background: Portuguese population is ageing. The lack of data on older adults’ nutritional status as well as the lack of nutrition knowledge of health professionals, caregivers, and older adults the...
Background: Portuguese population is ageing. The lack of data on older adults’ nutritional status as well as the lack of nutrition knowledge of health professionals, caregivers, and older adults themselves, remains a challenge. Objective: To reduce nutritional inequalities in the Portuguese older population and to improve the knowledge on Portuguese older adults’ nutritional status, specifically on undernutrition, obesity, sarcopenia, frailty, hydration, sodium and vitamin D status. Methods: A representative sample of Portuguese older adults was selected. Socio-demographic, lifestyles, anthropometric, functional and clinical data were collected. Sodium excretion, hydration and vitamin D status were assessed. Results: Data collection (n = 1,500) took place between December 2015 and May 2016. Results will be disseminated in national and international scientific journals as well in the Portuguese media. Conclusions: Nutrition UP 65 results will provide evidence for the design and implementation of effective preventive public health strategies regarding elderly. This will represent unequivocal health gains and costs savings.
Conventional cognitive behaviour therapy facilitated by an internet-based support system: a feasibility study at a psychiatric outpatient clinic
Date Submitted: May 27, 2016
Open Peer Review Period: May 27, 2016 - Jun 10, 2016
Background: Cognitive behaviour therapies (CBT) have been shown to be effective for a variety of psychiatric and somatic disorders, but some obstacles can be noted in regular psychiatric care, e.g. lo...
Background: Cognitive behaviour therapies (CBT) have been shown to be effective for a variety of psychiatric and somatic disorders, but some obstacles can be noted in regular psychiatric care, e.g. low adherence to treatment protocols may undermine effects. Treatments delivered via the internet have shown promising results, and it is an open question if the blend of internet-delivered and conventional face-to-face CBT may help to overcome some of the barriers of evidence-based treatments in psychiatric care. Objective: In the present study we evaluated the feasibility of an internet-based support system at an outpatient psychiatric clinic in Sweden. For instance, the support system made it possible to send messages, and share information between the therapist and the patient before and after therapy sessions at the clinic. Methods: Nine clinical psychologists participated and 33 patients were enrolled in the current study. We evaluated the usability and technology acceptance after 12 weeks of access. Moreover, clinical data on common psychiatric symptoms was assessed before and after the presentation of the support system. Results: In line with our previous study in a university setting, the internet-based support system appears to be feasible also when delivered in a regular psychiatric setting. Notably, some components in the system were less frequently used. We also found that the patients improved on common outcome measures for depressive and anxious symptoms (effect sizes, as determined by Cohen´s d, ranged from 0.29 to 0.66). Conclusions: This study adds to the literature showing that modern information technology can be aligned with conventional face-to-face services.
Designing an Adverse Drug Event Reporting System to Prevent Unintentional Re-exposures to Harmful Drugs: Study Protocol for a Multiple Methods Design
Date Submitted: May 26, 2016
Open Peer Review Period: May 27, 2016 - Jun 10, 2016
Background: Adverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within only six months because culprit drugs are unintentionally re-...
Background: Adverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within only six months because culprit drugs are unintentionally re-prescribed and re-dispensed. Improving the electronic communication of adverse drug event information between care providers and across care settings has the potential to reduce recurrent ADEs. Objective: To describe the methods used to design a novel electronic ADE reporting system that can be leveraged to prevent unintentional re-exposures to harmful drugs. Methods: To develop the new system, we will use action research, an approach that employs social scientific research methods and practitioner participation to generate insight into work settings and resolve problems, and participatory design. We will develop a systematic search strategy to review existing ADE reporting systems identified in academic and grey literature, and analyze the content of these systems to identify ‘core’ data fields used to communicate ADE information. We will observe care providers in the emergency departments and on the wards of two urban tertiary and one urban community hospital, in a rural ambulatory care centre, and in three community pharmacies in British Columbia, Canada. We will also conduct participatory workshops with providers to understand their needs and priorities related to communicating ADEs and preventing erroneous re-prescribing or re-dispensing of culprit medications. These methods will inform the iterative development of a preliminary paper-based reporting form which we will then pilot test with providers in a real-world setting. Results: This is an ongoing project with results being published as analysis is completed. The systematic review has been completed; field observations, focus groups, and pilot testing of a preliminary paper-based design is ongoing. Results will inform the development of software that will enable clinically useful user-friendly documentation and communication ADEs. Conclusions: We take this approach with the recognition that information technology-based solutions in health care often fall short of expectations as a result of designers’ failure to account for organizational and work practice considerations and the needs of end-users. We describe how integrating qualitative methods into an iterative participatory design process, planned in partnership with end-users, will allow us to address specific clinical needs, conceptualize linkages between systems, integrate the reporting system into clinicians’ workflow, and design the system to optimize its uptake into practice.
A Cross-Sectional Comparison of Drugable Mutations in Primary Tumors, Metastatic Tissue, Circulating Tumor Cells and Cell-Free Circulating DNA in Patients with Metastatic Breast Cancer: The MIRROR Study Protocol
Date Submitted: May 24, 2016
Open Peer Review Period: May 24, 2016 - Jun 1, 2016
Background: Characterization of the driver mutations in an individual metastatic breast cancer (MBC) patient is critical to selecting effective targeted therapies. Currently, it is believed that the l...
Background: Characterization of the driver mutations in an individual metastatic breast cancer (MBC) patient is critical to selecting effective targeted therapies. Currently, it is believed that the limited efficacy of many targeted drugs may be due to the expansion of drug resistant clones with different genotypes that were already present in the primary tumor. Identifying the genomic alterations of these clones and introducing combined or sequential targeted regimens could lead to a significant increase in the efficacy of currently available targeted therapies. Objective: The primary objective of this study is to assess the concordance/discordance of mutations between the primary tumor and metastatic tissue in these patients. Secondary objectives include comparing the genomic profiles of circulating tumor cells (CTCs) and circulating free DNA (cfDNA) from peripheral blood with those of the primary tumor and metastatic tissue for each patient, evaluating these mutations in the signaling pathways that are relevant to the disease, and testing the feasibility of introducing liquid biopsy as a translational laboratory tool in clinical practice. Methods: The multicenter, transversal, observational MIRROR study is currently ongoing in 3 participating hospitals. All consecutive patients with MBC confirmed by radiologic findings, either at first relapse or with tumor regrowth while on treatment for metastatic disease, will be screened for eligibility. Results: Patient’s recruitment is currently ongoing. To date, 41 patients have a complete set of tissue samples available (plasma, CTCs, and formalin-fixed, paraffin-embedded primary tumor and metastatic tumor). However, none of these samples have undergone nucleic acids extraction and targeted deep sequencing yet. Conclusions: The results of this study might have a significant influence on the practical management of patients with MBC, as they may provide clues to clinicians towards a better stratification of patients so that they receive more selective and less toxic treatments. Additionally, if genomic mutations found in metastatic tissues are similar to those detected in CTCs and/or cfDNA, then liquid biopsy could be a more convenient, non-invasive and easily accessible source of genomic material for the analysis of mutations and other genomic aberrations in MBC. Clinical Trial: ClinicalTrials.gov: NCT02626039
Study Protocol of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: An Observational Registry
Date Submitted: May 20, 2016
Open Peer Review Period: May 20, 2016 - Jun 3, 2016
Introdution: Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered t...
Introdution: Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered the first-line treatment for carotid stenosis worldwide, and the safety and efficacy of CAS compared with CEA remain in question. The purpose of this study is to compare the practice and outcomes of CAS and CEA in a real-world setting within public university hospitals in Brazil. Methods and Analysis: This will be a prospective 5-year analysis of treatment for atherosclerotic carotid stenosis with CEA and CAS performed at 5 centres affiliated with the Vascular Study Group at public university hospitals in Brazil. The indications for the procedure will be determined by each surgeon’s individual discretion, in accordance with preoperative risk evaluation. The primary outcome measures are (1) any in-hospital stroke or death and (2) any per-procedural stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS. All tests of significance will be performed at the 0.05 level. Ethics and Dissemination: This study was approved by Committee of Ethics in Research of University Hospital of Ribeirao Preto Medical School and in all other participating institutions linked to National Research System and National Board of Health in BRAZIL (Process 15695/2011) and the recruitment is currently on-going, the last patient is expected to be included by the end of 2018. The analysis of the primary end point and all others variables of the study are expected to be published in 2019 in a peer reviewed journal and results will also be presented at scientific meetings and summary results published online. .