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 2015: 4.532)
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
Does a novel wearable device improve health related quality of life of patients with an ostomy? A prospective, observational, crossover study protocol.
Date Submitted: Feb 12, 2017
Open Peer Review Period: Feb 20, 2017 - Mar 6, 2017
Background: Ostomy surgeries involving the placement of an ostomy bag (colostomy, ileostomy, urostomy, etc.) have been shown to have a negative impact on health-related quality of life. To date, no s...
Background: Ostomy surgeries involving the placement of an ostomy bag (colostomy, ileostomy, urostomy, etc.) have been shown to have a negative impact on health-related quality of life. To date, no studies have been conducted examining what impact, if any, wearable biosensors have on health-related quality of life of ostomy patients. Objective: In the present study, we plan to assess quality of life of ostomy patients using the Ostom-i alert sensor, a portable, wearable, Bluetooth linked biosensor that facilitates easier ostomy bag output measurements. We hypothesize that using the Ostom-i alert sensor will result in an improved, ostomy specific health related quality of life as compared to baseline measurement before the use of the sensor. Methods: A total of 20 ostomy patients will be screened and recruited to participate in this prospective, observational, crossover trial using Ostom-i alert sensor for one month. The primary outcome of this study will compare ostomy specific health related quality of life at baseline (prior to Ostom-i alert sensor use) to ostomy specific health-related quality of life after 2 and 4 weeks of Ostom-i use by utilizing the City of Hope Quality of Life Questionnaire for patients with an Ostomy (CoH-QOL-Ostomy). Secondary outcomes of general health related quality of life and adjustment to ostomy will be evaluated using the Medical Outcomes Study 36-item short form health survey (SF-36) and the Olbrisch Ostomy Adjustment Scale Short Form 2 (OAS-SF2). Results: Proposed benefits of mobile, internet linked personal health monitors such as the Ostom-i include a reduction in the cost of care by reducing resource utilization and infection rates, improving patient-provider communication, reducing time spent as an in-patient as well as improved quality of life. Prior studies have demonstrated decreased health related quality of life in patients with an ostomy bag. We aim to examine the extent to which the Ostom-i™ alert sensor affects health related quality of life of its users. Conclusions: The Ostom-i alert sensor has the potential to improve quality of life of users by giving them freedom and confidence to partake in daily activities with the knowledge that they can check how full their ostomy bag is in a private, discrete manner. Clinical Trial: clinicalTrials.gov: NCT02319434, first registered 15 December 2014.
Impact of a pharmaceutical intervention to improve adherence of inhaled medication in asthma and COPD patients
Date Submitted: Feb 17, 2017
Open Peer Review Period: Feb 20, 2017 - Mar 6, 2017
Background: Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitali...
Background: Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance. Objective: The primary objective of this study is to measure medication adherence in patients with chronic obstructive lung diseases such as asthma and COPD, and to investigate the impact of a reminder on disease outcomes and quality of life. Methods: In this ongoing prospective single-blind randomized controlled study, the adherence to inhaled medication is analyzed over a six-months period in at least 154 in- and outpatients with asthma or COPD, who have experienced at least one exacerbation during the last year. Adherence is measured using electronic data capture devices which save date and time of each inhalative device actuation and transfer these data daily via wireless-connection to a web-based database. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months. Results: Recruitment started in January 2014 and to date, a total of 169 patients have been recruited. Follow-up assessments are still ongoing. The study will be concluded in the first quarter of 2017. Data analysis will take place during 2017. Conclusions: To date, only few studies have investigated medication adherence in patients with chronic obstructive lung diseases. With the prospective study design and the use of state-of-the-art devices for measuring adherence, we expect scientifically relevant and clinically meaningful results that will have a substantial and positive impact on the provision of health care in chronically ill patients with asthma or COPD. Clinical Trial: ClinicalTrials.gov: NCT02386722; https://clinicaltrials.gov/ct2/show/NCT02386722 (archives by WebCite at http://www.webcitation.org/6oJq1fel0)
Testing the effectiveness of a primary care intervention to improve uptake of colorectal cancer screening: A randomised controlled trial protocol.
Date Submitted: Feb 6, 2017
Open Peer Review Period: Feb 19, 2017 - Mar 5, 2017
Background: Screening for colorectal cancer (CRC) significantly reduces mortality associated with this disease. In Australia, the National Bowel Cancer Screening Program provides regular faecal occult...
Background: Screening for colorectal cancer (CRC) significantly reduces mortality associated with this disease. In Australia, the National Bowel Cancer Screening Program provides regular faecal occult blood tests (FOBT) for those aged 50-74, however, participation rates in the program have plateaued at 36%. Considering low uptake in the National Bowel Cancer Screening Program it is necessary to explore alternate methods to increase CRC screening rates. Primary care is a promising adjunct setting to test methods to increase CRC screening participation. Primary care guidelines support the recommendation and provision of CRC screening in primary care patients. Those in the National Bowel Cancer Screening Program target age range frequently present to their primary care provider. Objective: This study tests the effect that printed advice on screening, provision of a free point-of-care FOBT and face-to-face primary care provider endorsement of screening delivered in an Australian primary care has on CRC screening uptake. Methods: Primary care patients presenting for an appointment with their primary care provider complete a touchscreen survey to determine eligibility for the trial. Those aged 50-74, at average risk of CRC, who have not have had a FOBT in the past two years or a colonoscopy in the past five years are eligible to participate in the trial. Trial participants are randomised to the intervention or usual care group by day of attendance at the practice. The intervention consists of provision of a FOBT, a printed information sheet and primary care provider endorsement to complete the FOBT. The usual care group receives no additional care. Results: The primary outcome is completion of CRC screening six weeks after recruitment. The proportion of patients completing CRC screening will be compared between trial groups using a logistic regression model. Conclusions: Protocol paper only Clinical Trial: This study was registered with the Australian New Zealand Clinical Trials Registry on 15th September 2016 (ACTRN12616001299493). The Universal Trial Number (UTN) for this trial is U1111-1185-6120.
Foot Reflexology Therapy for Non-Specific Low Back Pain Condition: A Protocol for A Randomized Controlled Trial
Date Submitted: Feb 7, 2017
Open Peer Review Period: Feb 19, 2017 - Mar 5, 2017
Background: Non-specific low back pain (NSLBP) is one of the most common physical ailments affecting millions of people worldwide. This condition constitutes a significant public health problem and wa...
Background: Non-specific low back pain (NSLBP) is one of the most common physical ailments affecting millions of people worldwide. This condition constitutes a significant public health problem and was listed as a prevalent health complaint in most societies. Even though there are many anecdotal claims for reflexology in the treatment of various conditions such as a migraine, arthritis and multiple sclerosis, but very little clinical evidence exist for reflexology on the management of low back pain per se. Objective: This study aim to evaluate the effects of foot reflexology therapy as an adjunctive treatment to the Malaysian low back pain standard care in relieving pain and promoting health related quality of life in people (HRQoL) with NSLBP. Methods: This is parallel randomized controlled trial in the reflexology therapy clinic, Kuala Terengganu, Malaysia; 100 people with non-specific low back pain will be allocated into one of two groups, using web-based application based on block randomisation. Outcome assessor and subjects will be blinded for group allocation. The control group will receive standard care, while the intervention group will receive standard care plus eight sessions, twice a week of foot reflexology therapy. The primary and secondary outcome variables are pain intensity and HRQoL respectively. Results: Outcome measures will be undertaken at pre-intervention (week 0), interim (week 1, week 2, week 3, week 4), post-intervention (week 6) and follow-up (week 10). Conclusions: This will be the first trail to compare the foot reflexology therapy with control group among people who medically diagnosed with NSPLB in Malaysia. The result of this study will contribute to better management of this population. Clinical Trial: This trail is registered in ClinicalTrials.gov, with the ID number of NCT02887430
Biometrics & Policing: A protocol for multichannel sensor data collection and exploratory analysis of contextualized psychophysiological response during law enforcement operations
Date Submitted: Feb 13, 2017
Open Peer Review Period: Feb 13, 2017 - Feb 22, 2017
Background: Stress experienced by law enforcement officers is often extreme and is in many ways unique from other professions. Although past research on officer stress is informative, it is limited, a...
Background: Stress experienced by law enforcement officers is often extreme and is in many ways unique from other professions. Although past research on officer stress is informative, it is limited, and most studies measure stress using self-report questionnaires or observational studies that suffer from limited generalizability. We know of no research studies that have attempted to track direct physiological stress responses in high fidelity, especially within an operational police setting. The outcome of this project will have an impact upon both practitioners and policing researchers. In doing so, we will establish a capacity to obtain complex, multi-sensor data; process complex datasets; and establish the methods needed to conduct idiopathic clinical trials on behavioral interventions in the similar contexts. Objective: The objective for this study is to demonstrate the practicality and utility of biometric sensor-based research in a law enforcement agency. Methods: This pilot study is intended to explore the feasibility of using wrist-worn biometric sensors in law enforcement. Non-probability convenience-based sampling will be used to recruit 2-3 participants from the Durham (NC) Police Department. Results: Data collection will be initiated in 2016. Data analysis will take place in early 2017 with results disseminated via peer-reviewed publications in late 2017. Conclusions: The Biometrics & Policing Demonstration project was developed to provide a proof of concept on collecting biometric data in a law enforcement setting. This effort will enable the authors to (1) address the regulatory approvals needed to collect data including human subject considerations; (2) demonstrate the ability to use biometric tracking technology in a policing setting; (3) link biometric data to law enforcement data; and (4) explore project results for law enforcement policy and training.
A systematic review on the effectiveness of school-based sex education program for youth in Asia
Date Submitted: Feb 11, 2017
Open Peer Review Period: Feb 11, 2017 - Feb 25, 2017
Background: This is a systematic review to assess the effectiveness of school-based sex education program among youngsters aged 12 or more who are going to school.All school going students with a prog...
Background: This is a systematic review to assess the effectiveness of school-based sex education program among youngsters aged 12 or more who are going to school.All school going students with a program of sex education as a part of their school are eligible.This review presents the finding from controlled school-based sex education intervention in promoting change in behavior toward sex, risk factors, self-hygiene.All the articles of Randomized control trial, cluster randomized trial, non-randomized trial and quasi-experiment done in any country of Asia are eligible for the study. All the article will be screened as per the inclusion and exclusion criteria and take care of duplicate article by Rev man software. This will be done anonymously by two researchers.After the screening and solving the conflict if any arise will be solved by discussing with the primary author.All the article will be screened by consort guideline and will be provided narrative analysis. Objective: The objective of the review is to find whether the school based- sex education program are effective in changing the behavior of young in controlling HIV, and STI. Methods: We will search the following electronic bibliographic database: MEDLINE, Embase, PUBMED, OVID, and the Cochrane Central Register of Controlled Trials (CENTRAL) for published peer-reviewed journal articles; and ClinicalTrials.gov and the World Health Organization's (WHO) International Clinical Trials Registry Platform for prospective trials; AIDS Education and Global Information System (AEGIS) and the Centers for Disease Control and Prevention (CDC), UNAIDS, the WHO and the National Health Service (NHS). Studies published between January 2000 and the date the search are run will be sought.The searches will be run just before the final analyses and further studies retrieved for inclusion. We will hand searched the reference lists of all relevant papers from manipal university.The search strategy will include only terms relating to or describing the intervention. The terms will be Combined with the Cochrane MEDLINE filter for controlled trials of interventions.The search terms will be adapted for use with other bibliographic databases in combination with database-specific filters for controlled trials, where these are available. Pubmed search strategy:- 1 sexual health education OR sex education OR Adolescent sex education OR reproductive health education 2 High school OR middle school OR secondary school 3 1 AND 2 4 race OR ethnicity OR black OR african american OR asian OR causation 5 3 AND (sexual orientation OR sexual behaviour) The search will be restricted to: Studies published in english at the time of search Studies conducted in asia Studies conducted in school setting Search string is as follow- effect[All Fields] AND ("schools"[MeSH Terms] OR "schools"[All Fields] OR "school"[All Fields]) AND based[All Fields] AND ("sex education"[MeSH Terms] OR ("sex"[All Fields] AND "education"[All Fields]) OR "sex education"[All Fields]) AND ("Intervention (Amstelveen)"[Journal] OR "intervention"[All Fields] OR "Interv Sch Clin"[Journal] OR "intervention"[All Fields]) AND ("behaviour"[All Fields] OR"behavior"[MeSH Terms] OR "behavior"[All Fields]) AND ("adolescent"[MeSH Terms] OR "adolescent"[All Fields]) Results: The result will be analysis on outcome variables that measure the effectiveness of school-based sex education program.information processing skills (reproductive health, boys, and girls), HIV, STI, students perceptions, risk behavior. change in the percentage of HIV, STI from baseline to last available article.All the article will be given importance on the intervention like the change of behavior.At last, the result will be shared with all the national health authority, WHO, UNICEF. Conclusions: The conclusion will be provided after the analysis of the systematic review. Clinical Trial: Method and content were approved by the Cochrane systematic review and published the protocol in their database.