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 2016: 5.175)
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
Protocol for a systematic review of substance use prevention programs for Indigenous adolescents in the United States of America, Canada, Australia and New Zealand
Date Submitted: Sep 20, 2017
Open Peer Review Period: Sep 21, 2017 - Oct 5, 2017
Indigenous adolescents are at higher risk of experiencing harms related to substance use, compared to their non-Indigenous counterparts as a consequence of earlier onset and higher rates of substance...
Indigenous adolescents are at higher risk of experiencing harms related to substance use, compared to their non-Indigenous counterparts as a consequence of earlier onset and higher rates of substance use. Early onset of substance use has been identified as a risk factor for future substance use problems and other health, social and family outcomes. Therefore, prevention of substance use among adolescents has been identified as a key area to improve Indigenous health. Evidence exists for the effectiveness of substance use prevention approaches for adolescents in mainstream populations and most recently, for the use of computer- and internet-delivered interventions to overcome barriers to implementation. However, there is currently no conclusive evidence about the effectiveness of these approaches for Indigenous adolescents. The purpose of this review is to synthesize the international evidence regarding the effectiveness of substance use prevention programs for Indigenous adolescents in the United States of America, Canada, Australia and New Zealand. Eight peer-reviewed databases will be searched, using search terms in line with the aims of this review and based on previous relevant reviews of substance use prevention. Studies will be included if they evaluate a substance use prevention program with Indigenous adolescents (aged 10 to 19) as the primary participant group and are published between 1 January 1990 and 31 August 2017. A narrative synthesis will be provided about the effectiveness of the programs, the type of program (whether cultural-based, adapted or unadapted), delivery of program (computer- and internet-delivered or traditional) and the setting in which the programs are delivered (community, school, family or a combination). The study will identify core elements of effective substance use prevention programs among Indigenous adolescents and appraise the methodological quality of the studies. This review will provide researchers, policy makers and program developers with evidence about the potential use of prevention approaches for Indigenous adolescents.
National Food, Nutrition and Physical Activity Survey of the Portuguese general population, 2015-2016: Design and methods
Date Submitted: Sep 18, 2017
Open Peer Review Period: Sep 20, 2017 - Oct 4, 2017
The National Food, Nutrition and Physical Activity Survey, 2015-2016 aimed to collect national and regional data on dietary habits and physical activity, and to evaluate their relation with health det...
The National Food, Nutrition and Physical Activity Survey, 2015-2016 aimed to collect national and regional data on dietary habits and physical activity, and to evaluate their relation with health determinants. Data were collected in a representative sample of the Portuguese general population (3 months to 84 years), by multistage sampling, and harmonized according to European guidelines/methodologies. An electronic platform was developed to manage the field work and to assist data collection by using Computer-assisted personal interviewing and includes the ‘eAT24’ module for dietary data collection by 24-hour recalls (two non-consecutive, 8-15 days apart) or food diaries in the case of children <10 years-old, synchronized with nutritional composition data and considering the FoodEx2 classification system; the ‘MOVE’ module for physical activity data (including the International Physical Activity Questionnaire, the Activity Choice Index, and 4-days physical activity diaries); and the ‘You’ module to collect sociodemographic and other health-related data. The results will assist policy planning and management of national health programs on the improvement of nutritional status and risk assessment related with food hazards, and the enhancement of physical activity. The infrastructures and data driven are a solid basis to the development of a future surveillance system reproducible over time.
Multicenter Study on the Burden of Illness of Oral Side Effects from Conditioning Therapy Before Stem Cell Transplantation “Ora-Stem Study”
Date Submitted: Sep 15, 2017
Open Peer Review Period: Sep 17, 2017 - Oct 1, 2017
Background: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of i...
Background: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of illness in the oral cavity from various cytotoxic therapies, it is difficult to produce evidence-based, preventive and management protocols. A prospective multicenter study is necessary to collect data on the burden of illness from various cytotoxic regimens. Objective: The objectives of this prospective international observational multicenter study in hematopoi-etic stem cell transplant (HSCT) patients are to establish the nature, incidence and temporal re-lationship of oral complications related to conditioning regimens (chemotherapy with or with-out total body irradiation-TBI), stem cell transplantation and the immunologic reactions (main-ly GVHD) that may follow, and to determine what subjective and objective oral complica-tions related to treatment can predict negative clinical and economic outcomes and reduced quality of life (QoL). Methods: Adult patients at six study sites receiving full intensity conditioning (FIC), reduced intensity conditioning (RIC) or non-myeloablative conditioning (NMA), followed by autologous or al-logeneic hematopoietic stem cell infusion, are included. A pre-treatment assessment includes medical conditions, planned chemo- and radiation therapy regimen, medications, allergies, so-cial history, patient report of oral problems, dental history, subjective oral complaints, objec-tive measures of oral conditions, current laboratory values, dental treatment recommended and untreated dental disease. Starting 1-3 days after hematopoietic stem cell infusion, a bedside assessment is completed 3 days/week until resolution of neutropenia. A patient questionnaire is also completed during hospitalization. Beyond this time, patients with continued oral mu-cositis or other oral problems are followed 1 day/week in an inpatient or outpatient setting. Additional visits for urgent care for acute oral problems after hospitalization are documented. Autologous transplant patients are being followed up at 100 days ±30 days and at 1 year ±30 days post-transplantation to identify any long-term side effects. Patients treated with alloge-neic transplantation are being followed at 100 days ±30 days, 6 months ±30 days, and 12 months ±30 days. The follow-up assessments include cancer response to therapy, current med-ical conditions, medications, subjective and objective oral findings, QoL measures and labora-tory values. Results: A total of 211 participants have been enrolled. We anticipate enrollment of 109 additional par-ticipants to obtain the sample size of 320. Conclusions: The results of the ongoing prospective study will provide a unique dataset to understand the impact of oral complications on patients undergoing HSCT and provide needed information with forming more evidence-based guidelines regarding the management of this patient co-hort.
Investigating the Impact of Hearing Aid Use and Auditory Training on Cognition, Mood and Social Interaction in Older Adults with Hearing Loss: the Study Protocol of a Crossover Trial
Date Submitted: Sep 11, 2017
Open Peer Review Period: Sep 15, 2017 - Sep 29, 2017
Background: Sensorineural type of hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech...
Background: Sensorineural type of hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. There is no clinically proven method to predict the onset of this condition, as its occurrence is slow and progressive, affecting both ears equally. Although hearing aid use and auditory training have been proven as successful interventions to alleviate sensorineural hearing loss, no research has been designed to look at the effect of simultaneous hearing aid use and auditory training on cognitive performance in older adults. Objective: The objective of this research study is to investigate in a randomized crossover trial, the impact of hearing aid use coupled with auditory training on cognition, mood, and social interaction, for older adults with sensorineural hearing loss. The rationale for this study is based on the hypothesis that, in older adults with sensorineural hearing loss, hearing aids in combination with auditory training will be more effective for improving cognition, mood, and social interaction, than auditory training on its own. Methods: This is a crossover trial targeting elderly men and women between 50 and 90 years with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will undergo a six month intensive auditory training program (active control), as a rigorous means of examining the impact of hearing aid use on cognition, mood and social interaction. Participants will be assigned in random order to receive hearing aid (intervention) for either the first three or last three months of the six month auditory training program. Each participant will be tested at baseline, three and six months on a battery of computer based cognitive assessments, together with mood, and social engagement measures. The primary outcome, cognitive performance, will be determined by a neuropsychological test battery. Secondary outcomes include mood and social interaction. The effectiveness of hearing aids and auditory training will be evaluated using an online speech perception test and the Abbreviated Profile of Hearing Aid Benefit (APHAB) Inventory. Results: This investigation is funded by the Australian Research Council and Blamey and Saunders Hearing Pty Ltd under the Industry Transformation Training Centre Scheme (ARC Project No. IC140100023) and it attained ethics approval on July 22, 2016 (Swinburne University Human Research Ethics Committee protocol number SHR Project 2016/159). Conclusions: This study will investigate whether using a hearing aid coupled with auditory training can improve a person’s cognition and learning abilities, relationships with family and friends, and quality of life. Results from the study will inform strategies for aural rehabilitation, hearing aid delivery and future hearing loss intervention trials. Clinical Trial: This trial is retrospectively registered at ClinicalTrials.gov, on April 13, 2017, identifier: NCT03112850.
Gut Hormone and Anti-Inflammatory Pathways Underlying Probiotic-effects on Glycaemic Control, Gut Microbiota and Quality of Life among Type 2 Diabetes Mellitus Patients: A Study Protocol
Date Submitted: Sep 7, 2017
Open Peer Review Period: Sep 9, 2017 - Sep 23, 2017
This manuscript needs more reviewersPeer-Review Me
Type 2 diabetes mellitus (T2DM) is a hyperglycaemic condition characterised with systemic inflammation and high oxidation level. Recently, imbalanced gut microbiota has been identified as one of the c...
Type 2 diabetes mellitus (T2DM) is a hyperglycaemic condition characterised with systemic inflammation and high oxidation level. Recently, imbalanced gut microbiota has been identified as one of the contributing factors in the development of T2DM. Modulation of gut microbiota in favour of good bacteria is essential for the management of T2DM. Probiotics are being increasingly recognised for their ability in modulating microbiota shift. This beneficial effect could potentially increase secretion of gut hormones, reduce systemic inflammation and oxidative stress among T2DM patients. The present clinical trial aims to determine the effects of probiotics on glycaemic control in T2DM patients. This trial will also elucidate the role of probiotics on anti-inflammatory markers, anti-oxidants, gut hormone regulation as well as alteration of intestinal microbiota composition in T2DM patients. Furthermore, this study evaluates changes in quality of life of the T2DM patients upon probiotics intake. A double-centre, double-blinded, placebo-controlled, randomised trial will be conducted at the Primary Care Medicine (PCM) clinics of the Clinical Training Centre (CTC) Sungai Buloh and the CTC Selayang, Universiti Teknologi MARA (UiTM), Selangor Darul Ehsan, Malaysia. One hundred T2DM adult patients will be recruited and will be randomly assigned into two groups, receiving either one capsule of probiotics (Chr Hansen, Denmark) or one capsule of placebo twice daily for 24 weeks. Changes in glycaemic parameters [i.e. glycosylated haemoglobin (HbA1c) as the primary outcome], levels of anti-inflammatory markers, anti-oxidants, gut hormone, anthropometric parameters, gut microbiota composition and quality of life will be determined. Both blood (all patients) and stool (20 patients only) samples will be collected during baseline assessment (prior to commencement of the clinical trial), week 12 and week 24 follow-up. Assessment of compliance and adverse events will be conducted throughout the study. It is anticipated that probiotics may induce beneficial changes in the gut microbiota, reduce systemic inflammatory state and oxidative stress as well as increase secretion of gut hormone, all of which may lead to improved glycaemic control and quality of life in T2DM patients. 100 subjects were estimated to be enrolled for this study. This study was initiated in December 2015. Currently, it is now at the stage of data collection and expected to complete by May 2018. Australian New Zealand Clinical Trial Registry (ANZCTR) Identifier: (ACTRN12615001135505)