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
Internet-delivered dialectical behavioral therapy skills training for suicidal and heavy episodic drinkers: Protocol for a randomized controlled trial
Date Submitted: Mar 27, 2017
Open Peer Review Period: Mar 30, 2017 - Apr 13, 2017
Background: The need to develop effective and accessible interventions for suicidal individuals engaging in heavy episodic drinking (HED) cannot be understated. While the link between alcohol use and...
Background: The need to develop effective and accessible interventions for suicidal individuals engaging in heavy episodic drinking (HED) cannot be understated. While the link between alcohol use and suicidality is a complex one that remains to be elucidated, emotion dysregulation may play a key role in alcohol-related suicide risk in these individuals. . Objective: In the current study, an 8-week Internet-delivered Dialectical Behavior Therapy (DBT) skills training intervention was developed and preliminarily evaluated for suicidal individuals who engage in HED to regulate emotions. The aim of the study is to evaluate the feasibility and effectiveness of the intervention, and to inform the design of a subsequent full-scale study Methods: The study is a pilot randomized control trial comparing participants receiving immediate treatment (n=30) to waitlist controls (n=29) over a period of 16 weeks. Intervention effects will be assessed longitudinally using generalized estimating equations, along with analyses of effect sizes and clinically significant change. The primary outcomes are suicidal ideation, alcohol problems, and emotion dysregulation. Secondary outcomes include alcohol-related consequences, reasons for living, skills use, and depression. Results: The trial is ongoing. A total of 60 individuals returned their informed consent and were randomized, of which 59 individuals were intended to treat. A total of 50 participants in the study were retained through the 16-week enrollment. Conclusions: There is a dearth of evidence-based treatment for those presenting with high risk and complex behaviors. Furthermore, computerized interventions may provide a beneficial alternative to traditional therapy. The particular clinical features and treatment needs of suicidal individuals who also engage in HED constitute key domains for further investigation needed to consolidate the design of appropriate interventions for this high-risk population. Clinical Trial: Clinical.gov identifier: NCT02932241; Date of registration: 10-Oct-2016
Study protocol for a randomised waiting list control trial, with embedded process evaluation, to investigate the impact of health promotion information on the wellbeing of people living with and beyond cancer.
Date Submitted: Mar 25, 2017
Open Peer Review Period: Mar 29, 2017 - Apr 12, 2017
Background: Evidence suggests physical activity can improve many of the common side-effects of cancer treatments, such as cancer related fatigue, psychological distress, and body composition, as well...
Background: Evidence suggests physical activity can improve many of the common side-effects of cancer treatments, such as cancer related fatigue, psychological distress, and body composition, as well as improving physical function and quality of life. Increased levels of physical activity have been shown to have a positive relationship with improved survival from cancer, and reduced recurrence of cancer. Despite the benefits, only 23% of UK cancer patients are active to recommended levels. Cancer patients are interested in lifestyle behaviour change, and home-based interventions offer a promising means for changing physical activity behaviours. Objective: This study protocol outlines the aims, methodology, study design, timelines for completion, and a brief discussion, of a waiting list randomised control trial into the impact of printed health promotion information, supported by online tools, on the physical activity behaviour, quality of life and self-efficacy of cancer patients. Method: This is a two arm, waiting list control study, with embedded process evaluation to understand the mechanisms for any change reported. The primary aim of this study is to test the effectiveness of a specifically designed printed health promotion resource, supported with access to online experts, e-newsletters, digital apps, online case studies, an online exercise to music video, and an online forum, in increasing physical activity in cancer patients. Baseline measures include physical activity, including pre-diagnosis levels of physical activity, self-efficacy, and quality of life. A sample of 82 participants per arm will be recruited through the channels of Macmillan Cancer Support. Participants will be randomised to receive very brief physical activity information, and the UK guidelines for physical activity, or very brief physical activity information, and the printed health promotion resource, supported by the online tools. The intervention and control groups will be followed up at 12 weeks to identify any changes in physical activity, self-efficacy, and quality of life. Sub group analysis will be carried out on the pre-diagnosis levels of physical activity and baseline self-efficacy, as possible predictors of successful behaviour change. The control group will receive the health promotion resources and online tools at 12 weeks, and followed up again at 24 weeks to monitor any change. The intervention group will be followed up at 24 weeks to see if changes are maintained. Results: Recruitment to this trail starts in March 2017 for one month. The planned completion of this 24 week study is October 2017. Conclusion: This study will investigate the effectiveness of an evidenced based printed health promotion resource, supported by online tools, in bringing about a change in the physical activity behaviour of cancer patients. It will identify the mechanisms for change, and in whom this intervention is most effective, in the context of self-efficacy and pre-diagnosis levels of physical activity.
Real-World Treatment Sequences and Outcomes among Patients with NSCLC the US: The RESOUNDS Study Protocol
Background: Survival outcomes are related to treatment choices in a line of therapy and treatment sequences across all lines of therapy. Objective: This study is designed to evaluate treatment sequenc...
Background: Survival outcomes are related to treatment choices in a line of therapy and treatment sequences across all lines of therapy. Objective: This study is designed to evaluate treatment sequences used for patients who receive at least two lines of therapy for non-small cell lung cancer (NSCLC) in the US, and to evaluate patient outcomes in terms of progression-free and overall survival related to treatment sequencing. Additional objectives include the evaluation of symptoms, comorbidities, health care resource utilization and costs. Methods: Eligible patients are those diagnosed with NSCLC who initiate second line therapy between November 2015 and December 2017, insured by Anthem, Inc. and are captured in the HealthCore database. All data are de-identified and then retrospectively reviewed in a longitudinal manner from the enrollment date until death, disenrollment from their health plan, or end of the study period. Data collected from each patient include cost and resource utilization from administrative claims, clinical data collected through a Clinical Cancer Quality Program, death dates from national mortality databases, supplemented with detailed clinical reports from patient medical records. Descriptive analyses will be reported; survival times will be estimated using Kaplan-Meier methods. Patients will be censored at loss to follow-up due to leaving the health plan or reaching the end of the study period. Results: - Conclusions: The RESOUNDS cohort study is a novel approach to build a comprehensive dataset that mimics a prospective observational study using linked patient-level data from four real-world data sources. This study will provide timely information as to the sequencing of treatments for patients with NSCLC.
The development of the ORALS (Open Recording Automated Logging System). Sharing annotated audio recordings of clinic visits with patients: A Study Protocol
Background: Providing patients with recordings of their clinic visits enhances patient and family engagement, yet few organizations routinely offer recordings. Challenges exist for organizations and p...
Background: Providing patients with recordings of their clinic visits enhances patient and family engagement, yet few organizations routinely offer recordings. Challenges exist for organizations and patients, including data safety and navigating lengthy recordings. A secure system that allows patients to easily navigate recordings may be a solution. Objective: The aim of the current project is to develop and test an interoperable system to facilitate routine recording - the Open Recording Automated Logging System (ORALS) - with the aim of increasing patient and family engagement. ORALS will consist of 1) technically proficient software using automated machine learning technology to enable accurate and automatic tagging of in-clinic audio recordings. Tagging involves identifying elements of the clinic visit most important to patients (e.g. treatment plan) on the recording; and 2) a secure, easy to use web interface, enabling the upload and accurate linkage of recordings to patients, which can be accessed at home. Methods: We will use a mixed methods approach to develop and formatively test ORALS in four iterative stages: a case study of pioneer clinics where recordings are currently offered to patients; ORALS design and user experience testing; ORALS software and user interface development; and rapid cycle testing of ORALS in a primary care clinic, assessing impact on patient and family engagement. The Dartmouth’s Informatics Collaboratory for design, development and dissemination (ic3d) team, patients, patient partners, caregivers and clinicians will assist in developing ORALS. Conclusions: Upon the completion of this project we will have developed a novel recording system (ORALS) that will be ready for large scale testing. Our long term goal is for ORALS to seamlessly fit into a clinic’s and patient’s daily routine, increasing levels of patient engagement and transparency of care.
Study protocol for a randomized control trial of an in-person vs eHealth mindfulness-based intervention for adolescents with chronic illness
Background: Eight-week mindfulness meditation programs have been shown to have a positive impact on mental health and well-being in adolescents with chronic health conditions. Usually delivered in per...
Background: Eight-week mindfulness meditation programs have been shown to have a positive impact on mental health and well-being in adolescents with chronic health conditions. Usually delivered in person in a group setting, these programs are difficult to access for teens with disabilities or who live in remote areas. Objective: To compare the impact of an adapted mindfulness-based intervention (MBI) delivered either in person or via eHealth on mindfulness skills acquisition in adolescents with a chronic health conditions. This study will also gather quantitative data on the effects of the MBI related to mood, anxiety, self-esteem, illness perception and stress (via salivary cortisol) as well as qualitative data on individual practice, participant appreciation and adaptation of the MBI for eHealth. Methods: This is a longitudinal, randomized non-inferiority study comparing two arms: in-person and eHealth. Participants are eligible to participate if they are 13-18 years old, have a diagnosis of chronic medical condition, live close enough to the recruitment hospital to participate in the in-person arm of the study and are currently followed by a healthcare provider. Each participant will receive an adapted eight-week MBI delivered either in person at a tertiary pediatric hospital or via a secure eHealth audio-visual platform allowing group interactions in real time. Groups will be facilitated by two experienced mindfulness providers. Quantitative and qualitative data will be collected through standardized research questionnaires administered via a secure, youth-friendly online platform, through semi-structured interviews, participant log books, facilitator log books and salivary cortisol analysis. Qualitative data will be analyzed using a grounded theory model. Results: Study recruitment is currently underway. The intervention and data collection will take place during the winter and spring of 2017. Conclusions: Based on previous results from in-person trials conducted in adolescents and eHealth trials conducted in adults, we anticipate that both modes of delivery will significantly improve mindfulness skills acquisition, mood, anxiety, self-esteem, illness perception and stress and that the magnitude of the effects will be correlated to the level of home practice. We predict that participants in both arms will show similar levels of home practice and that both modes of delivery will have high levels of feasibility and acceptability. If successful, this study could provide evidence for the use of eHealth in the delivery of eight-week MBIs in clinical adolescent populations, potentially increasing availability to MBIs for a large group of youth with mobility issues or living away from large urban centers. Clinical Trial: Trial registry: Clinicaltrials.org Trial number: NCT03067207 URL: https://clinicaltrials.gov/ct2/show/NCT03067207
Feasibility, Acceptability and Usability of an mHealth Framework to Improve Birth Outcomes: Study Protocol
Date Submitted: Mar 22, 2017
Open Peer Review Period: Mar 24, 2017 - Apr 7, 2017
Background: The unprecedented coverage of mobile technology across the globe have led to an increase in the use of mobile health applications and related strategies to make health information availabl...
Background: The unprecedented coverage of mobile technology across the globe have led to an increase in the use of mobile health applications and related strategies to make health information available at the point-of-care. These strategies have the potential to improve birth outcomes but are limited by the availability of internet services especially in resource-limited settings. Objective: Our primary objective is to determine the feasibility of developing an integrated mobile health platform that is able to collect data from community-based programs, embed collected data into a smart card and read the smart card using a cell phone based application without the need for internet access. Our secondary objective is to determine (i) the acceptability of the smart card among pregnant women and (ii) usability of the smart cards by pregnant women and health facilities. Methods: We will leverage existing technology to develop a platform that integrates a database, smart card technology, and a cell phone-based application to read the smart cards. We will recruit 300 pregnant women with one of the three conditions (HIV, hepatitis B virus infection and sickle cell trait or disease) and four health facilities in their community. We will use the Glasgow’s RE-AIM framework as a guide to assess the implementation, acceptability, and usability of the mHealth platform. Results: We have recruited four health facilities and 300 pregnant women with at least one of the eligible conditions. Over the course of 3 months, we will complete the development of the mobile health platform and each participant will be offered a smart card and staff in each health facility will receive training on the use of the mobile health platform. Conclusions: Findings from this study could offer a new approach to making health data from pregnant women available at point of delivery without the need for an internet connection. This would allow clinicians to implement evidence-based interventions in real time to improve health outcomes. Clinical Trial: ClinicalTrials.gov NCT03027258; https://clinicaltrials.gov/ct2/show/NCT03027258 (Archived by WebCite at http://www.webcitation.org/6owR2D0kE)