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Journal Description


JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed- and (new!) Scopus-indexed journal, publishing 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.

While the original focus was on eHealth studies, JMIR Res Protoc now publishes protocols and grant proposals in all areas of medicine, and their peer-review reports, if available (preliminary results from pilot studies, early results, and formative research should now be published in JMIR Formative Research).

While the original focus was on the design of medical and health-related research and technology innovations, JRP publishes research protocols, proposals, feasibility studies, methods and early results in all areas of medical and health research.

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 is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?

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 provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

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 proposals 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).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!


Recent Articles:

  • Brain-computer interface. Source: Flickr; Copyright: Ars Electronica; URL:; License: Licensed by JMIR.

    Evaluation of the Effectiveness of a Novel Brain-Computer Interface Neuromodulative Intervention to Relieve Neuropathic Pain Following Spinal Cord Injury:...


    Background: Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury. Spinal cord injury neuropathic pain often is poorly responsive to existing pharmacological and nonpharmacological treatments. A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback. However, further studies are needed to provide more definitive evidence regarding the effectiveness of this intervention. Objective: The primary objective of this study is to evaluate the effectiveness of a multiday course of a brain-computer interface neuromodulative intervention in a gaming environment to provide pain relief for individuals with neuropathic pain following spinal cord injury. Methods: We have developed a novel brain-computer interface-based neuromodulative intervention for spinal cord injury neuropathic pain. Our brain-computer interface neuromodulative treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) power. We will use a single-case experimental design with multiple baselines to examine the effectiveness of our self-developed brain-computer interface neuromodulative intervention for the treatment of spinal cord injury neuropathic pain. We will recruit 3 participants with spinal cord injury neuropathic pain. Each participant will be randomly allocated to a different baseline phase (ie, 7, 10, or 14 days), which will then be followed by 20 sessions of a 30-minute brain-computer interface neuromodulative intervention over a 4-week period. The visual analog scale assessing average pain intensity will serve as the primary outcome measure. We will also assess pain interference as a secondary outcome domain. Generalization measures will assess quality of life, sleep quality, and anxiety and depressive symptoms, as well as resting-state electroencephalography and thalamic γ-aminobutyric acid concentration. Results: This study was approved by the Human Research Committees of the University of New South Wales in July 2019 and the University of Technology Sydney in January 2020. We plan to begin the trial in October 2020 and expect to publish the results by the end of 2021. Conclusions: This clinical trial using single-case experimental design methodology has been designed to evaluate the effectiveness of a novel brain-computer interface neuromodulative treatment for people with neuropathic pain after spinal cord injury. Single-case experimental designs are considered a viable alternative approach to randomized clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000556943;

  • MiSELF-Logo. Source: Noun Project; Copyright: The Authors; URL:; License: Licensed by the authors.

    Psychological Treatment of Low Sexual Desire in Women: Protocol for a Randomized, Waitlist-Controlled Trial of Internet-Based Cognitive Behavioral and...


    Background: Psychological therapies are effective treatments for hypoactive sexual desire dysfunction (HSDD; formerly hypoactive sexual desire disorder), a common sexual dysfunction among women. Access to evidence-based treatments, however, remains difficult. Internet-based interventions are effective for a variety of psychological disorders and may be a promising means to close the treatment gap for HSDD. Objective: This article describes the treatment protocol and study design of a randomized controlled trial, aiming to study the efficacy of cognitive behavioral and mindfulness-based interventions delivered via the internet for women with HSDD to a waitlist control group. Outcomes are sexual desire (primary) and sexual distress (secondary). Additional variables (eg, depression, mindfulness, rumination) will be assessed as potential moderators or mediators of treatment success. Methods: A cognitive behavioral and a mindfulness-based self-help intervention for HSDD will be provided online. Overall, 266 women with HSDD will be recruited and assigned either to one of the intervention groups, or to a waitlist control group (2:2:1). Outcome data will be assessed at baseline, at 12 weeks, and at 6 and 12 months after randomization. Intention-to-treat and completer analyses will be conducted. Results: We expect improvements in sexual desire and sexuality-related distress in both intervention groups compared to the waitlist control. Recruitment has begun in January 2019 and is expected to be completed in August 2021. Results will be published in 2022. Conclusions: This study aims to contribute to the improvement and dissemination of psychological treatments for women with HSDD and to clarify whether cognitive behavioral and/or mindfulness-based treatments for HSDD are feasible and effective when delivered via the internet. Trial Registration: NCT03780751;

  • Source: Unsplash; Copyright: Burst; URL:; License: Licensed by the authors.

    Impact of a Web-Based Clinical Decision Support System to Assist Practitioners in Addressing Physical Activity and/or Healthy Eating for Smoking Cessation...


    Background: Modifiable risk factors such as tobacco use, physical inactivity, and poor diet account for a significant proportion of the preventable deaths in Canada. These factors are also known to cluster together, thereby compounding the risks of morbidity and mortality. Given this association, smoking cessation programs appear to be well-suited for integration of health promotion activities for other modifiable risk factors. The Smoking Treatment for Ontario Patients (STOP) program is a province-wide smoking cessation program that currently encourages practitioners to deliver Screening, Brief Intervention, and Referral to treatment for patients who are experiencing depressive symptoms or consume excessive amounts of alcohol via a web-enabled clinical decision support system. However, there is no available clinical decision support system for physical inactivity and poor diet, which are among the leading modifiable risk factors for chronic diseases. Objective: The aim of this study is to assess whether adding a computerized/web-enabled clinical decision support system for physical activity and diet to a smoking cessation program affects smoking cessation outcomes. Methods: This study is designed as a hybrid type 1 effectiveness/implementation randomized controlled trial to evaluate a web-enabled clinical decision support system for supporting practitioners in addressing patients’ physical activity and diet as part of smoking cessation treatment in a primary care setting. This design was chosen as it allows for simultaneous testing of the intervention, its delivery in target settings, and the potential for implementation in real-world situations. Intervention effectiveness will be measured using a two-arm randomized controlled trial. Health care practitioners will be unblinded to their patients’ treatment allocation; however, patients will be blinded to whether their practitioner receives the clinical decision support system for physical activity and/or fruit/vegetable consumption. The evaluation of implementation will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Results: Recruitment for the primary outcome of this study is ongoing and will be completed in November 2020. Results will be reported in March 2021. Conclusions: The findings of the study will provide much needed insight into whether adding a computerized/web-enabled clinical decision support system for physical activity and diet to a smoking cessation program affects smoking cessation outcome. Furthermore, the implementation evaluation would provide insight into the feasibility of online-based interventions for physical activity and diet in a smoking cessation program. Addressing these risk factors simultaneously could have significant positive effects on chronic disease and cancer prevention. Trial Registration: NCT04223336;

  • Source: Flickr; Copyright: NIAID; URL:; License: Licensed by JMIR.

    Country-Level Assessment of Missed Opportunities for Vaccination in South Africa: Protocol for Multilevel Analysis


    Background: Vaccination is one of the greatest public health interventions of all time. Vaccination coverage in South Africa has shown a steady improvement in reaching the national target. However, while there is progress nationally, there are districts within the country that are below the set target for vaccination coverage. One of the main drivers of suboptimal vaccination coverage is thought to be missed opportunities for vaccination. Objective: This study aims to understand the magnitude and determinants of missed opportunities for vaccination in South Africa. Methods: The 2016 South African Demographic and Health Survey will be used to conduct multilevel regression analyses to determine individual and contextual factors associated with missed opportunities for vaccination in South Africa. The perspectives of parents attending health care facilities in South Africa will be explored through exit interviews and focus group discussions. Similarly, perspectives of the health care providers will be sought to understand enablers and barriers to vaccination coverage at the facility level. Insights to such factors will aid in designing tailor-made interventions to improve vaccination coverage in South Africa. Results: Ethical review submission is planned for October 2020. Data collection is expected to be underway in January 2021. Conclusions: The extent of missed opportunities in South Africa coupled with the associated factors presents an opportunity for efforts to increase uptake in districts where vaccination coverage is below the national target. Population-level data such as those from the 2016 South African Demographic Health Survey will provide an idea of the magnitude of missed opportunities for vaccination in South Africa at the national and subnational levels. The findings of the study will inform national and subnational policy implementation on vaccinations and help to find context-specific interventions to improve vaccination coverage.

  • P4P Logo. Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    Pre-Exposure Prophylaxis Integration Into Family Planning Services at Title X Clinics in the Southeastern United States: Protocol for a Mixed Methods Hybrid...


    Background: Adolescent and young adult women (AYAW), particularly racial and ethnic minorities, in the Southern United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to family planning (FP) services that AYAW already trust, access routinely, and deem useful for their sexual health may offer an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. However, PrEP has not been widely integrated into FP services, including Title X–funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies. Objective: The objective of this study is two-fold: to evaluate multilevel factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics and to evaluate PrEP uptake, persistence, and adherence among female patients in these clinics over a 6-month follow-up period. Methods: Phase 2 of Planning4PrEP (Adolescent Medicine Trials Network for HIV/AIDS Interventions 155) is a mixed methods hybrid type 1 effectiveness implementation study to be conducted in three clinics in Metro Atlanta, Georgia, United States. Guided by the Exploration, Preparation, Implementation, and Sustainment framework, this study will prepare clinics for PrEP integration via clinic-wide trainings and technical assistance and will develop clinic-specific PrEP implementation plans. We will monitor and evaluate PrEP implementation as well as female patient PrEP uptake, persistence, and adherence over a 6-month follow-up period. Results: Phase 2 of Planning4PrEP research activities began in February 2018 and are ongoing. Qualitative data analysis is scheduled to begin in Fall 2020. Conclusions: This study seeks to evaluate factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics following training and implementation planning and to evaluate PrEP uptake, persistence, and adherence among female patients over a 6-month follow-up period. This will guide future strategies to support PrEP integration in Title X–funded clinics across the Southern United States. Trial Registration: NCT04097834;

  • Source: freepik; Copyright: pressfoto; URL:; License: Licensed by JMIR.

    Mobile Fitness and Weight Management Apps: Protocol for a Quality Evaluation


    Background: Obesity is a contributing factor for many noncommunicable diseases and a growing problem worldwide. Many mobile apps have been developed to help users improve their fitness and weight management behaviors. However, the speed at which apps are created and updated means that it is important to periodically assess their quality. Objective: The purpose of this study is to evaluate the quality of fitness and weight management mobile health apps using the Mobile Application Rating Scale (MARS). It will also describe the features of the included apps and compare the results to a previous evaluation conducted in 2015. Methods: Searches for “fitness,” “weight,” “exercise,” “physical activity,” “diet,” “eat*,” and “food” will be conducted in the Apple App Store and Google Play. Apps that have been updated over the past 5 years will be included. Two reviewers will rate the apps’ quality using the MARS objective and subjective quality subscales. Interrater reliability will also be assessed. Features included in high-quality apps will be assessed, and changes in quality, features, and behavior change techniques made during the past 5 years will be described. Results: The results will be included in the evaluation paper, which we aim to publish in 2020. Conclusions: This evaluation will assess the quality of currently available fitness and weight management apps.

  • Life STORRIED LOGO TOC. Source: Image created by the authors; Copyright: Camille Lin and Isabella Cuan; URL:; License: Creative Commons Attribution (CC-BY).

    Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized...


    Background: Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative–enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. Objective: Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. Methods: This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative–enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. Results: A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. Conclusions: This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. Trial Registration: NCT03134092;

  • Source: Image created by the authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    Effects of an Overground Walking Program With a Robotic Exoskeleton on Long-Term Manual Wheelchair Users With a Chronic Spinal Cord Injury: Protocol for a...


    Background: In wheelchair users with a chronic spinal cord injury (WUSCI), prolonged nonactive sitting time and reduced physical activity—typically linked to this mode of mobility—contribute to the development or exacerbation of cardiorespiratory, musculoskeletal, and endocrine-metabolic health complications that are often linked to increased risks of chronic pain or psychological morbidity. Limited evidence suggests that engaging in a walking program with a wearable robotic exoskeleton may be a promising physical activity intervention to counter these detrimental health effects. Objective: This study’s overall goals are as follows: (1) to determine the effects of a 16-week wearable robotic exoskeleton–assisted walking program on organic systems, functional capacities, and multifaceted psychosocial factors and (2) to determine self-reported satisfaction and perspectives with regard to the intervention and the device. Methods: A total of 20 WUSCI, who have had their injuries for more than 18 months, will complete an overground wearable robotic exoskeleton–assisted walking program (34 sessions; 60 min/session) supervised by a physiotherapist over a 16-week period (one to three sessions/week). Data will be collected 1 month prior to the program, at the beginning, and at the end as well as 2 months after completing the program. Assessments will characterize sociodemographic characteristics; anthropometric parameters; sensorimotor impairments; pain; lower extremity range of motion and spasticity; wheelchair abilities; cardiorespiratory fitness; upper extremity strength; bone architecture and mineral density at the femur, tibia, and radius; total and regional body composition; health-related quality of life; and psychological health. Interviews and an online questionnaire will be conducted to measure users’ satisfaction levels and perspectives at the end of the program. Differences across measurement times will be verified using appropriate parametric or nonparametric analyses of variance for repeated measures. Results: This study is currently underway with active recruitment in Montréal, Québec, Canada. Results are expected in the spring of 2021. Conclusions: The results from this study will be essential to guide the development, implementation, and evaluation of future evidence-based wearable robotic exoskeleton–assisted walking programs offered in the community, and to initiate a reflection regarding the use of wearable robotic exoskeletons during initial rehabilitation following a spinal cord injury. Trial Registration: NCT03989752;

  • Source: Plate et al.; Copyright: Plate et al.; URL:; License: Licensed by the authors.

    Reward Responsiveness, Optimism, and Social and Mental Functioning in Children Aged 6-7: Protocol of a Cross-Sectional Pilot Study


    Background: There is evidence that reward responsiveness and optimism are associated with mental and social functioning in adolescence and adulthood, but it is unknown if this is also the case for young children. Part of the reason for this gap in the literature is that the instruments that are used to assess reward responsiveness and optimism in adolescents and adults are usually not suitable for young children. Objective: Two behavioral tasks to assess reward learning, a questionnaire on reward responsiveness, and a questionnaire on optimism/pessimism will be tested on their feasibility and reliability in children aged 6-7. Depending on their feasibility and reliability, these instruments will also be used to investigate if reward responsiveness and optimism are associated with mental and social functioning in young children. Methods: For this cross-sectional pilot study, we adapted a number of tasks and questionnaires to the needs of 6-7-year-old children, by simplification of items, oral rather than written assessment, and reducing the number of conditions and items. We will approach teachers and, with their help, aim to include 70 children aged 6-7 to assess the feasibility and reliability of the tasks and questionnaires. Feasibility measures that will be reported are the proportion of children completing the task/questionnaire, the proportion of children that were able to explain the instructions in their own words to the researcher, and the proportion of children that correctly answered the control questions. The reliability of the scales will be assessed by computing Cronbach α and item-total score correlations and the reliability of the tasks by correlations between different consecutive blocks of trials. Ethics approval was obtained from the Ethics Committee of the Department of Pedagogy and Educational Sciences. Results: Data collection was originally planned in March and April 2020, but has been postponed due to Corona virus regulations. We expect to collect the data in the first half of 2021. The findings will be disseminated in preprints and peer-reviewed publications. Conclusions: The development of feasible and reliable instruments for assessing reward responsiveness and optimism in young children is expected to benefit future research on underlying mechanisms of mental and social functioning in young children. If the instruments assessed in this study are usable with young children, it would be particularly interesting to include them in cohort studies because this would enable investigating not only concurrent associations, but also prospective associations between reward responsiveness and optimism early in life and mental and social functioning later in life. If, as we hypothesize, reward responsiveness and optimism are not only associated with (prospective) mental and social functioning in adults and adolescents but also in young children, this could provide a way of identifying vulnerable children already at an early stage.

  • Source: Pexels; Copyright: Gerd; URL:; License: Licensed by JMIR.

    Guided Self-Help Behavioral Activation Intervention for Geriatric Depression: Protocol for Pilot Randomized Controlled Trial


    Background: Aging is a social concern. The increased incidence of depression in older populations in China poses a challenge to the health care system. Older adults who are depressed often suffer from a lack of motivation. Behavioral activation treatment, an evidence-based guided self-help treatment, is effective in reducing anhedonia and amotivation in depression; however, the efficacy of guided self-help behavioral activation in older adults with depression is not yet known. Objective: The aim of this study is to pilot a self-help guided intervention for the treatment of depression in older adults. Methods: This study has been designed as a pilot randomized controlled trial with inpatients (n=60; to be randomly allocated 1:1) between the ages of 60 and 70 and who have major depressive disorder. Patients attending clinical psychological clinics at the Mental Health Center of Chongqing will be randomized to either receive guided self-help behavioral activation (intervention) or to be on a 6-week waiting list (control). Participants in the treatment group will receive 6 sessions of guided self-help behavioral activation delivered over the telephone. The waiting list control group will receive the intervention after a period of 6 weeks. Exclusion criteria will be individuals who are at significant risk of harming themselves or others, who have a primary mental health disorder other than depression, or who have an intellectual disability that would hamper their ability to participate in the intervention. Effects of the treatment will be observed using outcomes in 3 domains: (1) clinical outcomes (symptom severity, recovery rate), (2) process variables (patient satisfaction, attendance, dropout), and (3) economic outcomes (cost and resource use). We will also examine mediators of outcomes in terms of patient variables (behavioral activation or inhibition motivation). We hypothesize that guided self-help behavioral activation will have a beneficial effect. Results: The study was approved by the research ethics committee of the Mental Health Center of Chongqing in November 2019. As of July 2020, recruitment had not yet begun. Data collection is expected to be completed by December 2020. Data analysis is expected to be completed by June 2021. Results will then be disseminated to patients, to the public, to clinicians, and to researchers through publications in journals and presentations at conferences. Conclusions: This will be the first study in China to investigate guided self-help interventions for patients who are older adults and who are depressed, a group which is currently underrepresented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression. The generalizability and broad inclusion criteria are strengths. Clinical Trial: Chinese Clinical Trial Register ChiCTR1900026066;

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    The Impact of Previsit Contextual Data Collection on Patient-Provider Communication and Patient Activation: Study Protocol for a Randomized Controlled Trial


    Background: Patient-centered care is respectful of and responsive to individual patient preferences, needs, and values. To provide patient-centered care, clinicians need to know and incorporate patients’ context into their communication and care with patients. Patient contextual data (PCD) encompass social determinants of health and patients’ needs, values, goals, and preferences relevant to their care. PCD can be challenging to collect as a routine component of the time-limited primary care visit. Objective: This study aims to determine if patient-provider communication and patient activation are different for patient users and patient nonusers of an electronic health record (EHR)–integrated PCD tool and assess if the impact of using PCD on patient-provider communication and patient activation differs for Black and White patients. Methods: We describe a randomized controlled trial of a prospective cohort of non-Hispanic White and Black patients who receive primary care services at a midwestern academic health care system in the United States. We will evaluate whether providing PCD through a consumer informatics tool enhances patient-provider communication, as measured by the Communication Assessment Tool, and we will evaluate patient activation, as measured by the Patient Activation Measure for PCD tool users and nonusers. Furthermore, owing to racial disparities in care and communication, we seek to determine if the adoption and use of the tool might narrow the differences between patient groups. Results: The trial was funded in November 2017 and received local ethics review approval in February 2019. The study began recruitment in April 2019 and enrollment concluded in October 2019 with 301 participants. The analysis was completed in May 2020, and trial results are expected to be published in winter 2020. Conclusions: Recently, there has been increased attention to the role of health information technology tools to enable patients to collaborate with providers through the sharing of PCD. The adoption of such tools may overcome the barriers of current EHRs by directly engaging patients to submit their contextual data. Effectively, these tools would support the EHR in providing a more holistic understanding of the patient. Research further supports that individuals who have robust digital engagement using consumer informatics tools have higher participation in treatment follow-up and self-care across populations. Therefore, it is critical to investigate interventions that elicit and share patients’ social risks and care preferences with the health care team as a mechanism to improve individualized care and reduce the gap in health outcomes. Clinical Trial: NCT03766841;

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    Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized...


    Background: Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents’ intrinsic motivation. The neurofeedback element reinforces relaxation abilities. Objective: This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. Methods: This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. Results: The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. Conclusions: Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. Trial Registration: Netherlands Trial Register NL6689 (NTR6859);

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  • iMedA: improving medication adherence through adaptive digital interventions in patients with hypertension: Protocol for an Interrupted time-series study

    Date Submitted: Sep 25, 2020

    Open Peer Review Period: Sep 22, 2020 - Nov 17, 2020

    Background: There is a strong need to improve medication adherence (MA) for hypertensive patients in order to reduce long-term hospitalization costs. We believe this can be achieved through an AI agen...

    Background: There is a strong need to improve medication adherence (MA) for hypertensive patients in order to reduce long-term hospitalization costs. We believe this can be achieved through an AI agent that helps the patient in understanding key individual adherence risk factors and designing an appropriate intervention plan. The incidence of hypertension in Sweden is estimated at approximately 27%. Among American adults diagnosed with hypertension only 54% had their condition under control; another 32% had prehypertension-level blood pressure. The direct and indirect healthcare costs due to uncontrolled hypertension in the US alone are estimated at 49 billion dollars each year. It is a major risk factor for coronary heart disease and stroke as well as heart failure. MA is a key factor for good clinical outcomes in hypertensive patients. Objective: The overall aim of this study is to design, develop, test, and evaluate an adaptive digital intervention called iMedA, delivered via a mobile app to improve MA and self-care management, and in longer-term blood pressure control, for persons with hypertension. Methods: The study design is considered to be an interrupted time series (ITS). We will collect data on a daily basis, 14 days before, during 6 months of delivering digital interventions through the mobile app, and after that. The effect will be analyzed using segmented regression analysis. The participants will be recruited in Region Halland, Sweden. The design of the digital interventions follows the Just-In-Time Adaptive Intervention (JITAI) framework. The primary (distal) outcome is MA, and the secondary outcome is blood pressure. The design of the digital intervention is developed based on a need assessment process including a systematic review, focus group interviews, and a pilot study, before going for the longitudinal ITS study. Results: The focus groups of persons with hypertension have been conducted to perform the need assessment. The design and development of digital interventions is under progress and is planned to be ready in September 2020. Then the 2-week pilot study for usability evaluation will get started, and then the ITS study will follow it, which we plan to start in October 2020. Conclusions: We hypothesize that iMedA will improve medication adherence and self-care management. This study could illustrate how self-care management tools can be an additional (digital) treatment support to a clinical one without increasing burden on healthcare staff. Clinical Trial: NCT04413500; adherence; hypertension; digital intervention; mHealth; Artificial Intelligence

  • Characterization of e-psychonauts and the new substances they consume: Protocol for a new Internet-based, Longitudinal Observational Methodology

    Date Submitted: Sep 25, 2020

    Open Peer Review Period: Sep 19, 2020 - Nov 14, 2020

    Background: During the last few years, the continuous emergence of new psychoactive substances (NPS) has become an important public health challenge. Not only has its use been rising both directly and...

    Background: During the last few years, the continuous emergence of new psychoactive substances (NPS) has become an important public health challenge. Not only has its use been rising both directly and as adulterants of traditional drugs, but also the number of new substances has been rising at a speed way beyond current scientific methodologies capacities. This has caused a remarkable absence of necessary information about newer drug effects on people who use drugs, mental Health professionals and policy makers. Current scientific methodologies have failed to provide enough data in the timeframe when critical decisions must be made, being not only too slow, but also too square. Last, but not least, they dramatically lack high resolution of phenomenological details Objective: To characterize a population of e-psychonauts and the subjective effects of the NPS they used during the study duration using a new, internet-based, fast and inexpensive methodology. This would allow bridging an evidence gap between online surveys, which do not provide substance confirmation, and clinical trials, which are too slow and expensive to keep up with the new substances appearing every week. Methods: To cover this purpose we designed a highly personalized, observational longitudinal study methodology. Participants will be recruited from online communities of people who use NPS and they will be followed online by means of a continuous objective and qualitative evaluation lasting for at least a year. Also, participants will send samples of the substances they intend to use during that period so they can be analyzed and matched with the effects they report on the questionnaires. Results: The research protocol was approved by the Hospital del Mar Research Institute (IMIM) IRB on the 11th of December of 2018. Data collection started in August 2019 and is still ongoing. ON September 26, 2020, 182 candidates have been screened and 60 participants accepted. From those, 16 have fully complied with the study requirements. Data analysis is expected to begin in November 2020 and the results are expected to be submitted for publication during 2021. Conclusions: Not available when the protocol is submitted Clinical Trial: Study approved by Hospital del Mar Research Institute IRB (IMIM-CEIC): 2018/8283/I

  • Feasibility, Usability, and Perceived Usefulness of the AFib 2getherTM Mobile App: Protocol Design Paper

    Date Submitted: Sep 17, 2020

    Open Peer Review Period: Sep 17, 2020 - Nov 12, 2020

    Background: The Center for Disease Control and Prevention has estimated that atrial fibrillation (AF) affects between 2.7-6.1 million people in the United States. Furthermore, those who have AF tend t...

    Background: The Center for Disease Control and Prevention has estimated that atrial fibrillation (AF) affects between 2.7-6.1 million people in the United States. Furthermore, those who have AF tend to have a much higher stroke risk than others. Although many individuals could largely benefit from an anticoagulant (AC), a significant majority are hesitant to start AC therapy. To further this issue, some providers tend to find themselves struggling to determine the risks and benefits of prescribing their patients AC. To assist in the communication between patient and provider preferences and knowledge regarding AC, different strategies are being used to try and solve this gap. In this research study, we have both patients and providers utilize the AFib 2getherTM app with hopes that it will create a platform for shared decision-making regarding management and treatment of AF with AC. Objective: The aims of our study are to measure usability, perceived usefulness to patients and providers, and feasibility of conducting shared decision visits using the mobile app, AFib 2getherTM. To measure provider knowledge of and confidence in utilizing a modern AF management approach and its association with the usability and feasibility. Methods: Eligible patients and providers will evaluate the AFib 2getherTM mobile app for usability and helpfulness in facilitating shared decision making on understanding the patient’s risk of stroke and whether or not to start AC. Both patients and providers will review the app and complete multiple questionnaires about the usability & feasibility of the mobile app in a clinical setting. Results: Enrollment in the AFib 2getherTM shared decision-making study is still ongoing for both patients and providers. Conclusions: The AFib 2getherTM app emerged from the desire to increase patient and provider ability for shared decision-making around understanding risk of stroke and about AC. We hope the AFib 2getherTM mobile app will facilitate patient discussion with their cardiology and other providers. Additionally, we hope the study will help us identify a focus point in barriers that providers face when placing patients on AC. We aim to demonstrate the usability and feasibility of the app with a future goal of testing the value of our approach in a larger sample of patients and providers at multiple medical centers across the country. Clinical Trial: NCT04118270

  • A protocol for an integrated mixed-method approach to determining how to mitigate antimicrobial resistance across the One Health spectrum

    Date Submitted: Sep 16, 2020

    Open Peer Review Period: Sep 16, 2020 - Nov 11, 2020

    Background: Antimicrobial resistance (AMR) is an existing and looming global challenge with serious health, social and economic consequences. Building social and ecological resilience to reduce AMR an...

    Background: Antimicrobial resistance (AMR) is an existing and looming global challenge with serious health, social and economic consequences. Building social and ecological resilience to reduce AMR and mitigate its impact is critical. Objective: The objective is to describe the protocol for a study designed to compare and assess interventions that address AMR in humans, animals and/or the environment and engage diverse perspectives to determine what actions will help to build social and ecological capacity and readiness to tackle AMR now and in the future. Methods: We identify interventions that address AMR and its key pressure antimicrobial use in the scientific literature and through an online survey. Intervention impacts and the factors that challenge or contribute to the success of interventions will be determined, triangulated against expert opinion in participatory workshops, and complemented using quantitative time-series analyses. We will then identify indicators, using regression modelling, which can predict national AMU or AMR dynamics across animal and human health. Together, these analyses will help to quantify causal loop diagrams of AMR in the Europe and Southeast Asian food system context that are developed by diverse stakeholders in participatory workshops. Then, using these CLDs, the long-term impacts of selected interventions on AMR will be explored under alternate future scenarios via simulation modelling and participatory workshops. A publicly available and evolving learning platform housing information about interventions on AMR from a One Health perspective in a fully accessible online database will be developed, to help decision-makers to identify and adapt promising interventions for application in their jurisdictions. Results: This study is currently underway but not complete. Interventions from the case review and online survey have been identified, the expert-feedback and model-building workshops have been conducted, and collected data are currently being analysed. Time series analysis, regression modelling of national and regional indicators of AMR dynamics, and scenario modelling activities are anticipated to be completed by Spring 2021. Ethics approval has been obtained from the University of Waterloo’s Office of Research Ethics (ethics number: 40519 and 41781). Conclusions: This protocol provides an example of how to study complex problems like AMR, which require the integration of knowledge across sectors and disciplines, to develop and implement sustainable solutions. We anticipate our study will contribute to understanding about what actions to take and in what contexts to ensure long-term success in mitigating AMR and its impact, and provide useful tools (e.g., causal loop diagrams, simulation models, public database of compiled interventions) to guide management and policy decisions. Clinical Trial: N/A

  • De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Trial rationale, protocol, and progress to date

    Date Submitted: Sep 16, 2020

    Open Peer Review Period: Sep 15, 2020 - Nov 10, 2020

    Background: Overdose deaths from prescription opioid analgesics are a continuing crisis in the United States. Opioid analgesics are among the most frequently prescribed drugs by dentists. An estimated...

    Background: Overdose deaths from prescription opioid analgesics are a continuing crisis in the United States. Opioid analgesics are among the most frequently prescribed drugs by dentists. An estimated 5 million people undergo third-molar extractions in the United States each year, resulting in postoperative pain. Studies show that in most cases the combination of ibuprofen and acetaminophen is an effective alternative to commonly-prescribed opioid analgesics for the management of post-extraction pain. Nevertheless, many dentists routinely prescribe opioids after dental extractions. Objective: We describe the rationale, design, and methods for a randomized trial of interventions designed to de-implement opioid prescribing by dentists while implementing effective non-opioid analgesics following dental extractions. Methods: Using a prospective, 3-arm cluster randomized trial design with dentists as the unit randomized and patient-level prescribing data as the primary outcome, we will compare different strategies to reduce the reliance on opioids and increase the use of alternative pain management approaches utilizing information support tools aimed at both providers and their patients. The study will test the efficacy of two interventions to decrease opioid prescribing following dental extractions: Clinical Decision Support (CDS), and CDS with Patient Education (CDS-E). Providers will be randomized to CDS, CDS-E, or standard practice. Patient-level outcomes will be determined via review of comprehensive electronic health records. We will compare study arms on differential change in prescribing patterns from pre- to post-implementation of the intervention. The primary outcome of interest is a binary indicator of whether or not the patient received an opioid prescription on the day of the extraction encounter. We will also examine recommendations or prescriptions for non-opioid analgesics, patients’ perception of shared decision making, and patients’ pain experiences following the extraction. Results: The HealthPartners Institutional Review Board has approved the study. All study materials including the CDS and patient education materials have been developed and pilot tested and the protocol has been approved by National Institute of Dental and Craniofacial Research (NIDCR). The intervention was implemented in February 2020 and data collection has begun. Conclusions: If the intervention strategies are shown to be effective, they could be implemented more broadly in dental settings with high levels of opioid prescribing. Clinical Trial: Identifier: NCT03584789

  • Evaluation of nutritional status, food intake and food waste costs in ‎hospitalized patients, considering relevant causes and finding possible ‎solutions: Protocol of a mixed-method study

    Date Submitted: Sep 5, 2020

    Open Peer Review Period: Sep 5, 2020 - Oct 31, 2020

    Background: Hospitalization may seriously affect patients’ nutritional status and may ‎occasionally be accompanied by malnutrition development or aggravation. Food intake is ‎often altered durin...

    Background: Hospitalization may seriously affect patients’ nutritional status and may ‎occasionally be accompanied by malnutrition development or aggravation. Food intake is ‎often altered during hospitalization, which is tightly connected to malnutrition. On the other ‎hand, a huge amount of plate food wasted by patients, in addition to its health consequences, ‎has enormous economic and environmental expenses for governments and societies. Objective: This ‎investigation aims firstly to assess the nutritional status of the patients hospitalized in general ‎wards and secondly to evaluate the quantity and financial burden of patients’ food waste ‎along with its possible nutritional outcomes.‎ Methods: A mixed-method study is performed in three general hospitals in Tehran. Adult ‎inpatients with eligibility criteria are recruited to the study from medical and surgical ‎wards. Anthropometric and demographic data are collected and energy and protein intakes ‎are extracted from a 24-hour food recall. Plate food wastes of eligible patients are weighed ‎in breakfast, lunch, and snacks during one day. Then, the economic cost of food waste is ‎calculated for each meal, patient, and ward. Nutritional status is determined through the ‎following methods: 1. Subjective criteria (Mini Nutritional Assessment and Subjective ‎Global Assessment tools) for malnutrition; 2. Measuring serum albumin, pre-albumin and ‎total protein for protein status; 3. Measuring serum retinol and 25-hydroxycalciferol assay ‎to assess certain micronutrient status (vitamins A and D); and 4. Examination of serum β-‎carotene, total antioxidant capacity, malondialdehyde, and highly sensitive C-reactive ‎protein to determine oxidative stress and inflammatory status. Also, a qualitative study is ‎conducted to evaluate the possible reasons for wasting food in these hospitals.‎ Results: The project is approved and funded in January 2020 by the Research Committee of ‎National Nutrition and Food Technology Research Institute (NNFTRI) at Shahid Beheshti ‎University of Medical Sciences. Due to the Corona pandemic, we could just recruit 34 ‎participants as of the submission of the manuscript, no data analysis has been performed and ‎the authors expect to publish the results in winter 2021.‎ Conclusions: This study will provide appropriate data regarding the health and economic burden ‎of food waste in studied hospitals. These data are especially useful to healthcare authorities ‎and policymakers for planning efficient solutions to decrease food waste and to improve ‎patients' nutritional status. ‎