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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:

  • Source: Flickr; Copyright: Open Grid Scheduler / Grid Engine; URL: https://www.flickr.com/photos/opengridscheduler/44315865590; License: Public Domain (CC0).

    Efficacy of Functional Foods, Beverages, and Supplements Claiming to Alleviate Air Travel Symptoms: Protocol for a Systematic Review

    Abstract:

    Background: Airline passengers often experience symptoms when travelling on long and ultra-long flights. These range from minor discomforts such as gastrointestinal symptoms to more serious life-threatening clinical conditions such as deep vein thrombosis. The food and supplement industry have responded with a plethora of products that claim to prevent one or more of the physiological or psychological symptoms associated with air travel. Objective: The aim of this literature review is to evaluate the efficacy of functional foods, beverages, and supplements that claim to address the unwanted effects of air travel in healthy adult populations. Methods: This research is a two-stage process. The first step is a scoping review of the functional foods, beverages, and supplements making claims that they lessen or prevent the physical or psychological symptoms associated with commercial air travel. Databases (ie, Medline, Embase, PsycINFO, and Web of Science), gray literature (ie, the flight catering magazines PAX International, APEX, and Onboard Hospitality), and search engines (ie, Google and Bing) will be used to identify products and generate a database. The second stage is a systematic literature review of the evidence supporting any health claims made for such products. The search will be conducted in Medline, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Central Register of Controlled Trials. Additionally, gray literature that includes the reference list of studies included in the systematic literature review and scientific articles referenced by the products within our database will be hand searched. Randomized and nonrandomized controlled trials reporting on changes in flight-related physical or cognitive symptoms in healthy adults that were conducted in commercial flight or flight simulation settings will be included. Two authors will independently screen, extract data, and assess the strength of evidence and risk of bias of the studies. The strength of evidence will be judged using the Grading of Recommendations, Assessments, Developments, and Evaluations approach, and the risk of bias will be assessed using the appropriate Cochrane Collaboration tool (Risk of Bias for Randomized Control Trials II or Robins I for Nonrandomized Interventions). Results: The scoping review of available functional foods, beverages, and supplements was conducted from March 6, 2019, to August 31, 2019. The systematic literature review commenced on October 1, 2019. The review is expected to be completed in 2020. Conclusions: The review findings will help consumers and employees of commercial airlines make informed decisions on their use of functional foods and beverages for alleviating air travel–related symptoms.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/3/e16461/; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).

    Evaluating Mobile Apps and Biosensing Devices to Monitor Physical Activity and Respiratory Function in Smokers With and Without Respiratory Symptoms or...

    Abstract:

    Background: Chronic obstructive pulmonary disease (COPD) is a global public health problem, and continuous monitoring is essential for both its management as well as the management of other chronic diseases. Telemonitoring using mobile health (mHealth) devices has the potential to promote self-management, improve control, increase quality of life, and prevent hospital admissions. Objective: This study aims to demonstrate whether a large-scale study assessing the use of mHealth devices to improve the treatment, assessment, compliance, and outcomes of chronic diseases, particularly COPD and cardio-metabolic syndrome, is feasible. This will allow our team to select the appropriate design and characteristics for our large-scale study. Methods: A total of 3 cohorts, with 9 participants in each, will use mHealth devices for 90 days while undergoing the current standard of care. These groups are: 9 “non-COPD,” otherwise healthy, smokers; 9 “grey zone” smokers (forced expiratory volume in 1 second/ forced vital capacity ≥0.70 after bronchodilator treatment; COPD Assessment Test ≥10); and 9 smokers diagnosed with Stage 1-3 COPD. Rates of recruitment, retention, and adherence will be measured. Overall, two mHealth devices will be utilized in the study: the AnaMed Original Equipment Manufacturer device (measures distance, energy expenditure, heart rate, and heart rate variability) and the Air Next mobile spirometry device. The mHealth devices will be compared against industry standards. Additionally, a questionnaire will be administered to assess the participants’ perceptions of the mHealth technologies used. Results: The inclusion of participants started in June 2019. Study results will be published in peer-reviewed scientific journals. Conclusions: This study will demonstrate whether a large-scale study to assess the use of mHealth devices to improve the treatment, assessment, compliance, and outcomes of chronic diseases, particularly COPD and cardio-metabolic syndrome, is feasible. It will also allow the research team to select the appropriate design and characteristics for the large-scale study. Trial Registration: ClinicalTrials.gov NCT04081961; https://clinicaltrials.gov/ct2/show/NCT04081961

  • Source: Shutterstock; Copyright: sasirin pamai; URL: https://www.shutterstock.com/fr/image-photo/asian-senior-elderly-old-lady-woman-1092388982; License: Licensed by the authors.

    Influence of Cognitive Functioning on Powered Mobility Device Use: Protocol for a Systematic Review

    Abstract:

    Background: Power mobility devices (PMD) are critical to achieving independent mobility and social participation for many individuals who have trouble walking. Provision of PMDs is complex, with cognitive functioning expressed by clinicians as a major concern. Even if PMD use can be predicted by the level of cognitive functioning, outcome tools used to assess readiness do not consider how cognitive functioning may affect PMD use. Objective: The specific aims of this review are to identify existing assessments used to assess cognitive functioning and PMD use, classify cognitive functions that are identified within existing assessments related to PMD use, and explore the relationships between cognitive functioning (ie, executive functions and attention) and PMD use. Methods: A systematic review will be conducted using the electronic databases MEDLINE (Ovid), CINAHL, Embase, PsycINFO (Ovid), and Web of Science based on the concepts of PMD performance and capacity, and cognitive functioning. To be included, studies must have: a sample of PMD users (inclusive of age and diagnoses), an assessment of cognitive functioning, and an assessment of PMD capacity or performance. The International Classification of Functioning, Disability and Health will be used to classify cognitive functions. Study quality will be assessed using the Mixed Methods Appraisal Tool. Qualitative and quantitative studies will be analyzed in a complementary manner depending on their designs; a result-based convergent synthesis design will be applied. Results: This proposed systematic review protocol has been registered in PROSPERO (CRD42019118957). It was funded by the Quebec Rehabilitation Research Network and approved on February 2019. Conclusions: Results will inform the development of a PMD driving program that aims to enhance cognition. The results of this study will enhance understanding of the influence of cognitive functioning on PMD use and will support the clinical practice in choosing appropriate evaluative tools. Trial Registration: PROSPERO CRD42019118957; https://www.crd.york.ac.uk/PROSPERO/display_record.php? RecordID=118957

  • Young woman completing online task in a busy classroom. Source: Unsplash; Copyright: Fran Innocenti; URL: https://unsplash.com/photos/ij8xP91j8jM; License: Licensed by JMIR.

    Youth Experiences With Referrals to Mental Health Services in Canada: Protocol for a Web-Based Cross-Sectional Survey Study

    Abstract:

    Background: Youth mental health is an important public health concern affecting low-, middle-, and high-income countries, and many young people in need of mental health services do not receive the care they need when they need it. An early step in accessing mental health care is the referral process, yet most of the research done on pathways to care has focused on clinical populations (eg, first-episode psychosis) recruited from mental health care settings. There has been limited research attention on the experiences of referral to mental health services from the perspectives of youth recruited from the general population who may or may not have received the services they need. Objective: This study aims to investigate the experiences that youth between the ages of 17 and 30 years have with referrals to mental health services and to better understand their perspectives on the use of technology to facilitate referrals. Methods: This study will use a cross-sectional, Web-based survey design. A convenience sample of 400 participants from 3 Canadian provinces (Quebec, Ontario, and British Columbia), between the ages of 17 and 30 years, will be recruited via Facebook and will be invited to complete a Web-based survey anonymously. A questionnaire including a series of quantitative and qualitative questions will ask participants about their sociodemographic characteristics, past experiences with referral and access to mental health services, and opinions about using technology to facilitate the referral process. Results: Participant recruitment is planned to be initiated by early January 2020 and is estimated to be completed by May 2020. Data will be analyzed using descriptive statistics and logistic regression or chi-square tests for quantitative data, and descriptive content analysis will be used for the qualitative data. Conclusions: The results of this study can help inform the improvement of referral policies and procedures in youth mental health service delivery. A better understanding of young people’s perspectives on referral processes and their opinions on how these processes can be improved are essential to providing appropriate and timely access to mental health care.

  • Source: Pixabay; Copyright: Enhialus; URL: https://pixabay.com/photos/audit-data-analytics-computer-4171740/; License: Licensed by JMIR.

    Three Decades of Internet- and Computer-Based Interventions for the Treatment of Depression: Protocol for a Systematic Review and Meta-Analysis

    Abstract:

    Background: Depression is one of the leading causes of disability worldwide. Internet- and computer-based interventions (IBIs) have been shown to provide effective, scalable forms of treatment. More than 100 controlled trials and a growing number of meta-analyses published over the past 30 years have demonstrated the efficacy of IBIs in reducing symptoms in the short and long term. Despite the large body of research, no comprehensive review or meta-analysis has been conducted to date that evaluates how the effectiveness of IBIs has evolved over time. Objective: This systematic review and meta-analysis aims to evaluate whether there has been a change in the effectiveness of IBIs on the treatment of depression over the past 30 years and to identify potential variables moderating the effect size. Methods: A sensitive search strategy will be executed across the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and PsycINFO. Data extraction and evaluation will be conducted by two independent researchers. Risk of bias will be assessed. A multilevel meta-regression model will be used to analyze the data and estimate effect size. Results: The search was completed in mid-2019. We expect the results to be submitted for publication in early 2020. Conclusions: The year 2020 will mark 30 years since the first paper was published on the use of IBIs for the treatment of depression. Despite the large and rapidly growing body of research in the field, evaluations of effectiveness to date are missing the temporal dimension. This review will address that gap and provide valuable analysis of how the effectiveness of interventions has evolved over the past three decades; which participant-, intervention-, and study-related variables moderate changes in effectiveness; and where research in the field may benefit from increased focus. Trial Registration: PROSPERO CRD42019136554; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=136554

  • Surgical back-table step. Source: Matteo Ravaioli; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/3/e13922/; License: Creative Commons Attribution (CC-BY).

    Hypothermic Oxygenated Perfusion Versus Static Cold Storage for Expanded Criteria Donors in Liver and Kidney Transplantation: Protocol for a Single-Center...

    Abstract:

    Background: Extended criteria donors (ECD) are widely utilized due to organ shortage, but they may increase the risk of graft dysfunction and poorer outcomes. Hypothermic oxygenated perfusion (HOPE) is a recent organ preservation strategy for marginal kidney and liver grafts, allowing a redirect from anaerobic metabolism to aerobic metabolism under hypothermic conditions and protecting grafts from oxidative species–related damage. These mechanisms may improve graft function and survival. Objective: With this study, we will evaluate the benefit of end-ischemic HOPE on ECD grafts for livers and kidneys as compared to static cold storage (SCS). The aim of the study is to demonstrate the ability of HOPE to improve graft function and postoperative outcomes of ECD kidney and liver recipients. Methods: This is an open-label, single-center randomized clinical trial with the aim of comparing HOPE with SCS in ECD kidney and liver transplantation. In the study protocol, which has been approved by the ethics committee, 220 patients (110 liver recipients and 110 kidney recipients) will be enrolled. Livers and kidneys assigned to the HOPE group undergo machine perfusion with cold Belzer solution (4-10°C) and continuous oxygenation (partial pressure of oxygen of 500-600 mm Hg). In the control group, livers and kidneys undergoing SCS are steeped in Celsior solution and stored on ice. Using the same perfusion machine for both liver and kidney grafts, organs are perfused from the start of the back-table procedure until implantation, without increasing the cold ischemia time. For each group, we will evaluate clinical outcomes, graft function tests, histologic findings, perfusate, and the number of allocated organs. Publication of the results is expected to begin in 2021. Results: Dynamic preservation methods for organs from high-risk donors should improve graft dysfunction after transplantation. To date, we have recruited 108 participants. The study is ongoing, and recruitment of participants will continue until January 2020. Conclusions: The proposed preservation method should improve ECD graft function and consequently the postoperative patient outcomes. Trial Registration: ClinicalTrials.gov NCT03837197; https://clinicaltrials.gov/ct2/show/NCT03837197 ; Archived by WebCite® at http://www.webcitation.org/76fSutT3R

  • Two mentees. Source: Catalysts; Copyright: Catalysts; License: Licensed by the authors.

    Digitally Enhanced Mentoring for Immigrant Youth Social Capital: Protocol for a Mixed Methods Pilot Study and a Randomized Controlled Trial

    Abstract:

    Background: There are large disparities between immigrants and native Norwegians in domains such as health, education, and employment. Reducing such disparities is essential for individual and societal well-being. Social capital is associated with positive effects on these domains, and mentoring programs have the potential to boost social capital. However, few studies have assessed mentoring as a social capital intervention among youth or the potential barriers and facilitators of implementing digitally augmented mentoring. Objective: The goal of this paper is to describe a protocol for assessing the implementation and effectiveness of a digitally augmented mentoring program for immigrant youth as a health intervention to promote social capital. The two-stage analytical framework for a pilot study followed by a randomized controlled trial (RCT) is presented. The pilot aims to assess program fidelity and make necessary intervention adjustments before the RCT. The RCT aims to assess the effects of the implemented intervention program on social capital and the relationship between program fidelity and effects. Methods: Both the pilot and RCT will use mixed methods with a process evaluation approach used to structure the intervention and a pre-post test survey component to measure social capital and fidelity of program implementation. Interviews will also be used to enrich the quantitative data from the survey. Results: The pilot study is scheduled to begin in fall 2019. Based on data analyses in spring 2020, potential adjustments will be made to the intervention, with findings used in preparation for the full-scale RCT study. Conclusions: Digitally enhanced mentoring programs may be a helpful intervention for providing immigrant youth with tools for increasing their social capital and indirectly improving health outcomes. This protocol provides new knowledge about the implementation and evaluation of such programs.

  • Source: Pixabay; Copyright: Stocksnap; URL: https://pixabay.com/photos/pills-medicine-medication-medical-2607338/; License: Licensed by JMIR.

    Impact of Removing Nonprescription Codeine in Australia: Protocol for a Prospective Cohort Study

    Abstract:

    Background: On February 1, 2018, Australia rescheduled codeine to a prescription-only medication. Many concerns were associated with this change, including increased financial costs, reduced service accessibility, the potential for poorer pain management, and a decline in physical and mental health if codeine could not be accessed. In the research literature, there is limited knowledge about the long-term consequences of rescheduling pharmaceutical opioids and, as Australia has followed many countries in implementing a restriction on codeine, further study of these consequences is critical. Objective: The goal of this study was to examine the impact of rescheduling codeine from an over-the-counter (OTC) product to a prescription-only medicine on the primary measures of codeine use and dependence in a prospective cohort of people who are frequent consumers of OTC codeine. Secondary measures included pain and self-efficacy, health service use, and mental health. Methods: The Codeine Cohort study aimed to recruit 300 participants in Australia who regularly (at least a few times per week for the past 6 months) used OTC codeine. Using an online survey, participants were followed up at three time points (February 2018, June 2018, and February 2019) after codeine was rescheduled. Results: All four waves of data collection are complete, with the final round of data collection finalized in August 2019. Data analyses are yet to be completed. Information on demographics, codeine use and dependence, physical and mental health, medication use, and health service use will be analyzed using mixed models. Conclusions: Results of this study will provide insight into the effectiveness of regulatory restriction in curtailing nonmedical use of and harms associated with codeine. Additionally, results will explore positive and negative outcomes of codeine rescheduling for individual patients, which informs health professionals who support patients who use codeine and further community education.

  • Source: The Authors/ Placeit; Copyright: JMIR Publications; URL: https://www.researchprotocols.org/2020/3/e13409; License: Creative Commons Attribution (CC-BY).

    A Mobile App for Thyroid Cancer Patients Aiming to Enhance Their Quality of Life: Protocol for a Quasiexperimental Interventional Pilot Study

    Abstract:

    Background: Thyroid cancer (TC) is one of the fastest growing cancers all over the world. Differentiated thyroid cancer (DTC) is the most frequent subtype of TC. When appropriate treatment is given, the prognosis for the patient is generally excellent. Despite the generally good prognosis of thyroid carcinomas, the symptoms may range from emotional to physical discomfort, depending on the thyroid hormone status, which can severely affect the patient. Moreover, the diagnostic and therapeutic procedures that DTC patients have to undergo, such as thyroidectomy and radioiodine therapy, significantly affect their mental and physical well-being. Often, the physician only addresses the favorable prognosis of DTC compared with other cancer types and neglects to assess issues related to the quality of life (QoL) of the patient; this was the reason we decided to design a mobile app for DTC patients and their caregivers. Objective: The aim of this study is to research the feasibility and applicability of an mHealth app tailored to DTC patients, as reflected in their QoL. The main features of the developed app offer access to useful information about thyroid cancer, diagnostic tests, and the appropriate therapy administered to DTC patients. Methods: Based on the existing literature, we created an up-to-date information platform regarding TC and especially DTC. In order to develop an effective app that can be implemented in current health care, we designed a section where the patient and physician can keep a medical record in an effort to enable access to such information at any time. Finally, we designed a user-friendly notification program, including pill prescription, follow-up tests, and doctor visit reminders in order to equally facilitate the lives of the patient and physician. Results: Having developed this mobile app, we aim to conduct a pilot quasiexperimental interventional trial. Our intention is to enroll at least 30 TC patients and assign them to intervention or control groups. Both groups will receive standard care for treating and monitoring TC, and the intervention group will also receive and use the DTC app. TC patients’ QoL will be assessed for both control and intervention groups in order to examine the effectiveness of the DTC app. QoL will be assessed through the QoL core questionnaire European Organisation for Research and Treatment of Cancer (EORTC) QLQ-THY34 in combination with the EORTC QLQ-C30 questionnaire through quantitative statistical analysis. Conclusions: The use of mHealth apps can play a significant role in patient education, disease self-management, remote monitoring of patients, and QoL improvement. However, the main limitation of the majority of existing studies has been the lack of assessing their usefulness as well as the absence of specific instruments to carry out this assessment. In light of those considerations, we developed a mobile app tailored to the needs of DTC patients. Furthermore, we evaluated its contribution to the QoL of the patients by using the EORTC QLQ-THY34 questionnaire, an accurate and safe instrument for the evaluation of the QoL in TC patients, while supporting future planned endeavors in the field.

  • Source: Freepik; Copyright: javi_indy; URL: https://www.freepik.com/free-photo/female-doctor-explaining-diagnosis-her-young-woman-patient_1319037.htm#page=1&query=doctor%20patient&position=46; License: Licensed by JMIR.

    Brief Intervention to Prevent Sexually Transmitted Infections and Unintended Pregnancies: Protocol of a Mixed Methods Feasibility Study

    Abstract:

    Background: Sexual well-being is fundamental to physical and emotional health, and the ability to achieve it depends on access to comprehensive sexuality information and high-quality sexual health care from evidence-informed, nonjudgmental providers. Adequate and timely delivery of these components to individuals who are at high risk for sexually transmitted infections (STIs), including HIV, and unintended pregnancies promotes sexual health and mitigates consequences arising from risky sexual behavior. Brief interventions that allow health care providers to improve the information available to clients and motivate and help them to develop risk-reduction skills are seen as efficient ways to improve knowledge, change client behavior, and reduce provider stigma regarding sexual health. Objective: The aim of the study is to evaluate five aspects of feasibility (acceptability, willingness, safety, satisfaction, and process) of a brief sexuality-related communication (BSC) intervention based on motivational interviewing and behavior change techniques in primary health care settings in low- and middle-income countries (LMICs). Methods: This protocol outlines a multisite, multiphase study of feasibility of a BSC intervention in primary health care settings in LMICs that will be examined across four phases of the study. Phases I through III involve the collection of formative, qualitative data to examine provider and client perceptions of the feasibility of the intervention, adaptation of the intervention guide, and training providers on how to implement the final version of the BSC intervention. During phase IV, the feasibility of the intervention will be tested in a nonrandomized pre-post test trial where providers and clients will be followed for 6 months and participate in multiphase data collection. Results: Phase I is currently underway in Moldova, and phases I and II were completed in Peru in late 2019. Results are expected for the feasibility study in 2021. Conclusions: This feasibility study will determine whether the implementation of brief intervention programs aimed at improving sexual health outcomes is possible in the constraints of LMIC health systems and will add to our understanding of factors shaping clinical practice among primary care providers.

  • Untitled. Source: freepik; Copyright: Rawpixel; URL: https://www.freepik.com/free-photo/man-working-his-laptop_3679544.htm#page=3&query=man+using+laptop&position=1; License: Licensed by JMIR.

    Effectiveness of Conversational Agents (Virtual Assistants) in Health Care: Protocol for a Systematic Review

    Abstract:

    Background: Conversational agents (also known as chatbots) have evolved in recent decades to become multimodal, multifunctional platforms with potential to automate a diverse range of health-related activities supporting the general public, patients, and physicians. Multiple studies have reported the development of these agents, and recent systematic reviews have described the scope of use of conversational agents in health care. However, there is scarce research on the effectiveness of these systems; thus, their viability and applicability are unclear. Objective: The objective of this systematic review is to assess the effectiveness of conversational agents in health care and to identify limitations, adverse events, and areas for future investigation of these agents. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols will be used to structure this protocol. The focus of the systematic review is guided by a population, intervention, comparator, and outcome framework. A systematic search of the PubMed (Medline), EMBASE, CINAHL, and Web of Science databases will be conducted. Two authors will independently screen the titles and abstracts of the identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. Two reviewers will independently extract and validate data from the included studies into a standardized form and conduct quality appraisal. Results: As of January 2020, we have begun a preliminary literature search and piloting of the study selection process. Conclusions: This systematic review aims to clarify the effectiveness, limitations, and future applications of conversational agents in health care. Our findings may be useful to inform the future development of conversational agents and promote the personalization of patient care.

  • Source: Pixabay; Copyright: Starllyte; URL: https://pixabay.com/photos/operation-open-heart-surgery-1915653/; License: Creative Commons Attribution (CC-BY).

    Thanatogenomic Investigation of the Hydroxymethylome and Mitochondrial Genome of Cadaveric Cardiomyocytes: Proposal for a Proof-of-Concept Study

    Abstract:

    Background: Cardiovascular disease (CVD) remains the leading cause of death in the United Arab Emirates (UAE). One of the common CVDs is hypertrophic cardiomyopathy (HCM). Recent studies conducted in heart cells of mice have shown that this condition involves a chemical modification called hydroxymethylation of the DNA of heart cells. Objective: Objectives of the proposed research are to profile the distribution of 5-hydroxymethylation in the cardiomyocyte (CMC) genome of cadaveric cardiac tissue and cardiac biopsy specimens; to compare the hydroxymethylome of cadaveric CMCs with that of cardiac biopsy specimens from HCM patients and/or cardiac transplant patients (control) undergoing cardiac catheterization; to histologically appraise sarcomere distribution and mitochondrial morphology of CMCs in the presence of HCM; to correlate the mitochondrial genome with the HCM phenotype; and to integrate anatomy with biochemistry and genetics into the instructional design of HCM in the core medical curriculum at Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU). Methods: Normal and hypertrophic heart specimens will be obtained from 8 whole-body cadavers (2/8, 25% control and 6/8, 75% HCM). Myocardial biopsy specimens will be obtained from cardiothoracic and transplant units at the Cleveland Clinic in Abu Dhabi, UAE. As this is a proof-of-concept study, we plan to recruit 5 patients with HCM, where HCM has been diagnosed according to the guidelines of the 2014 European Society of Cardiology Guidelines. Patients with valvular heart disease, history of myocarditis, regular alcohol consumption, or cardiotoxic chemotherapy will be excluded. The control biopsy specimens will be obtained from patients who had received heart transplants. Three investigational approaches will then be employed: (1) gross anatomical evaluation, (2) histological analysis, and (3) profiling and analysis of the hydroxymethylome. These investigations will be pursued with minor modifications, if required, to the standard protocols and in accordance with institutional policy. The objective associated with the education of health professionals will be addressed through a strategy based on Graham’s knowledge translation model. Results: This study is at the protocol-development stage. The validated questionnaires have been identified in relation to the objectives. The MBRU and the Cleveland Clinic Abu Dhabi Institutional Review Board (IRB) are reviewing this study. Further clarification and information can be obtained from the MBRU IRB. There is funding in place for this study (MBRU-CM-RG2019-08). Currently, we are in the process of standardizing the protocols with respect to the various molecular techniques to be employed during the course of the study. The total duration of the proposed research is 24 months, with a provision for 6 months of a no-cost extension. Conclusions: The spectrum of CVDs has recently received significant focus from the public health sector in the UAE. HCM is a common familial heart disease, contributing to the sudden increase in the mortality rate of young Emiratis in the UAE. Incorporating artificial intelligence into the identification of epigenetic risk factors associated with HCM will promote accurate diagnosis and lead to the development of improved management plans, hence, positive patient outcomes. Furthermore, integration of these findings into the instructional design of undergraduate, postgraduate, and continuous professional development medical curricula will further contribute to the body of knowledge regarding HCM.

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    Date Submitted: Mar 26, 2020

    Open Peer Review Period: Mar 26, 2020 - May 21, 2020

    Background: Brief counseling can motivate patients to initiate health behavior change. However, increasing the provision of brief counseling by acute care nurses is difficult due to contextual and pra...

    Background: Brief counseling can motivate patients to initiate health behavior change. However, increasing the provision of brief counseling by acute care nurses is difficult due to contextual and practitioner-level factors impeding nurses’ motivation and intentions to provide brief counseling (e.g., unfavorable attitude toward brief counseling, lack of perceived control linked to barriers). Moreover, most brief counseling training programs lack accessibility and personalization. Theory-based, adaptive e-learning programs could provide accessible and personalized brief counseling training. Objective: This paper presents a study protocol for evaluating the effectiveness of a theory-based, adaptive e-learning program on acute care nurses’ intentions to provide brief counseling for smoking, an unbalanced diet and medication nonadherence. Methods: A two-group, multicenter RCT will be conducted with acute care nurses (N=186). Nurses will be randomized to a theory-based, adaptive e-learning program (E_MOTIVA; experimental group) or knowledge-based, standardized e-learning program (E_MOTIVB; active control group). The E_MOTIVA program was designed to influence the constructs of the Theory of Planned Behavior (e.g., attitude, subjective norm and perceived behavioral control) in relation to brief counseling. The Cognitive Load Index and User Engagement Scale will be used to assess nurses’ cognitive load and engagement related to e-learning. Nurses will complete the Brief Counseling Nursing Practices Questionnaire at baseline and between 41- and 50-day post-randomization. Results: The study is ongoing (ISRCTN32603572). Conclusions: This study will be amongst the first in evaluating a theory-based, adaptive e-learning program in nurses. These programs have the potential to support evidence-based practice through accessible, personalized training in wide-ranging domains in nursing. Clinical Trial: ISRCTN Registry; ISRCTN32603572; https://www.isrctn.com/ISRCTN32603572

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    Date Submitted: Mar 22, 2020

    Open Peer Review Period: Mar 22, 2020 - May 17, 2020

    Background: The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Use of diagnostic endoscopic retrograde cholangiopancrea...

    Background: The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Use of diagnostic endoscopic retrograde cholangiopancreatography should be minimized as it carries considerable risk of post-procedural complications. Objective: This study compares two different management strategies: intraoperative cholangiography and endoscopic ultrasound before laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis and intermediate risk for choledocholithiasis. Methods: It is a diagnostic randomized active-controlled single-center clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy due to symptomatic gallbladder stones with intermediate risk for choledocholithiasis. The risk for choledocholithiasis is calculated using an original prognostic score – Vilnius University Hospital Index. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm (“Endoscopy first”). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be administered in another arm (“Cholecystectomy first”). Postoperative follow-up is 6 months. Results: The primary endpoint is the length of hospital stay. Secondary endpoints will include accuracy of the different management strategies, adverse events of interventions, duct clearance and technical success of interventions (intraoperative cholangiography, endoscopic ultrasound, endoscopic retrograde cholangiography), costs of treatment. Conclusions: This trial is planned determine which strategy is better approach for a patient with intermediate common bile duct stones risk and to define a simple to calculate and safe algorithm on managing choledocholithiasis. Clinical Trial: The trial is registered at ClinicalTrials.gov, identification number NCT03658863.

  • Closing the Gap Between Mammalian and Invertebrate Peripheral Nerve Injury: A Novel Nerve Repair Protocol

    Date Submitted: Mar 13, 2020

    Open Peer Review Period: Mar 12, 2020 - May 7, 2020

    Background: Outcomes after peripheral nerve injuries are poor despite current nerve repair techniques. Currently, there is no conclusive evidence that mammalian axons are capable of spontaneous fusion...

    Background: Outcomes after peripheral nerve injuries are poor despite current nerve repair techniques. Currently, there is no conclusive evidence that mammalian axons are capable of spontaneous fusion after transection. Notably, certain invertebrate species have the ability to auto-fuse after transection. Although mammalian axonal auto-fusion has not been observed experimentally, no mammalian study to date has demonstrated regenerating axolemmal membranes contacting intact distal segment axolemmal membranes to determine whether mammalian peripheral nerve axons have the intrinsic mechanisms necessary to auto-fuse after transection. Objective: This study aims to assess fusion competence between regenerating axons and intact distal segment axons by enhancing axon regeneration, delaying Wallerian Degeneration, limiting the immune response, and preventing myelin obstruction. Methods: This study will use a rat sciatic nerve model to evaluate the effects of a novel peripheral nerve repair protocol on behavioral, electrophysiologic, and morphologic parameters. This protocol consists of a variety of pre-, intra-, and post- operative interventions. Fusion will be assessed with electrophysiological conduction of action potentials across the repaired transection site. Axon-axon contact will be assessed with transmission electron microscopy. Behavioral recovery will be analyzed with the sciatic functional index. A total of 36 rats will be used for this study. The experimental group will use 24 rats and the negative control group will use 12 rats. For both the experimental and negative control groups, there will be a behavior group and another group that will undergo electrophysiological and morphological analysis. The primary endpoint will be the presence or absence of action potentials across the lesion site. Secondary endpoints will include behavioral recovery with the sciatic functional index and morphological analysis of axon-axon contact between regenerating axons and intact distal segment axons. Results: We are in the process of grant funding and IRB approval as of March 2020. The final follow-up will be completed by December 2021. Conclusions: In this study, the efficacy of the proposed novel peripheral nerve repair protocol will be evaluated using behavioral and electrophysiologic parameters. The author believes this study will provide information regarding whether spontaneous axon fusion is possible in mammals under the proper conditions. This information could potentially be translated to clinical trials if successful in an effort to improve outcomes after peripheral nerve injury.

  • NOtifications To improve Engagement (NOTE) with an alcohol reduction app: protocol for a micro-randomised trial

    Date Submitted: Mar 12, 2020

    Open Peer Review Period: Mar 12, 2020 - May 7, 2020

    Background: Drink Less is a behaviour change app which aims to help users in the general adult population reduce hazardous and harmful alcohol consumption. The app includes a daily push notification,...

    Background: Drink Less is a behaviour change app which aims to help users in the general adult population reduce hazardous and harmful alcohol consumption. The app includes a daily push notification, delivered at 11am, asking users to “Please complete your mood and drinking diaries”. Previous analysis with Drink Less engagement data suggests the current notification strongly influences how users engage with the app in the subsequent hour of delivery, and patterns of engagement fluctuate over the course of the day, with an increase in frequency and duration of use observed between 8pm to 10pm. We aim to improve engagement by exploring the content and sequence of notifications delivered at 8pm, where we will test a bank of 30 new evidence-informed notifications which intend to increase the user’s perceived usefulness of the app. Objective: The primary objective is to assess if sending a notification at 8pm increases behavioural engagement in the subsequent hour. Secondary objectives include comparing the effect of the new bank of messages with the standard message and effect moderation over time. We also aim to more generally understand the role notifications have on the overall duration, depth and frequency of engagement with Drink Less over 30 days since download. Methods: This is a protocol for a micro-randomised trial with two parallel arms. The parallel arms include receiving no notifications (Secondary Arm A), and users receiving the standard notification “Please complete your mood and drinking diaries”, delivered daily at 11am (Secondary Arm B) over 30 days. Inclusion criteria include: users who i) consent to participate in the trial; ii) self-report a baseline Alcohol Use Disorders Identification Test (AUDIT) score of 8 or above; iii) reside in the UK; iv) are aged 18+ years and; v) report being interested in drinking less alcohol. The primary outcome is the time-varying, binary outcome of “Did the user login in to the app in the hour from 8pm to 9pm?”. The primary analysis will measure the marginal effect of the notifications, quantified as a relative risk with a 95% confidence interval, using an estimator developed for micro-randomised trials with binary outcomes. The parallel arms will allow us to compare the effect of different notification delivery strategies on overall engagement. Results: Ethical approval was granted by UCL’s Departmental Research Ethics Committee (CEHP/2016/556) on 11th October 2019 and LSHTM’s Interventions Research Ethics Committee (17929) on 27th November 2019. Recruitment began on the 2nd January 2020 and is currently ongoing. Conclusions: Understanding how push notifications may impact engagement with a behaviour change app can lead to further improvements in engagement, and ultimately help users reduce their alcohol consumption. This understanding may also be generalisable to other apps that target a variety of behaviour changes.

  • A mobile health app (AGRIPPA) to prevent relapse after successful interdisciplinary treatment for patients with chronic pain: protocol for a randomized controlled trial

    Date Submitted: Mar 9, 2020

    Open Peer Review Period: Mar 9, 2020 - May 4, 2020

    Background: To facilitate adherence to adaptive pain management behaviours after interdisciplinary multimodal pain treatment, we developed an mHealth application (i.e. AGRIPPA app) that contains two b...

    Background: To facilitate adherence to adaptive pain management behaviours after interdisciplinary multimodal pain treatment, we developed an mHealth application (i.e. AGRIPPA app) that contains two behaviour regulation strategies. Objective: This study has three main objectives: (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app-users. Methods: We will perform a multicentre randomised controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the six participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months post-treatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and healthcare expenses. Results: The study was approved by the local Medical Research Ethics Committee in October 2019. As of 20 March 2020, we have recruited 88 patients. Conclusions: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After three years of development and feasibility testing, this formal evaluation will help determine to what extent the application will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.

  • Assessing a WeChat-based integrative family intervention (WIFI) for schizophrenia: protocol for a stepped-wedge cluster randomized trial

    Date Submitted: Mar 3, 2020

    Open Peer Review Period: Mar 3, 2020 - Apr 28, 2020

    Background: Schizophrenia is a persistent and debilitating mental illness, whose prognosis depends largely on supportive care and systematic treatment. In developing countries like China, family const...

    Background: Schizophrenia is a persistent and debilitating mental illness, whose prognosis depends largely on supportive care and systematic treatment. In developing countries like China, family constitute the major caregiving force for schizophrenia and are faced with many challenges, such as lack of knowledge, skills and resources. How to support family caregiving in an accessible, affordable, feasible and cost-effective way remains unresolved. The widely spread use of WeChat provides a promising and cost-effective medium for support. Objective: The current study aims to assess a WeChat WeChat-based integrative family intervention (WIFI) to support family caregiving of schizophrenia. Methods: A WIFI program will be developed that include three core components: 1) psycho-education through WeChat Official Account (WOA), 2) peer support through WeChat chat group, and 3) professional support through WeChat video chat. A rigorous stepped wedge cluster randomized trial will be used to evaluate the implementation, effectiveness, and cost of the WIFI program. The WIFI program will be implemented in 12 communities affiliated with the Changsha psychiatric hospital through the free medicine delivery process in the 686 Program. The 12 communities will be randomized to one of four fixed sequences every two months during an 8-month intervention period in four clusters of 3 communities each. Outcomes will be assessed for both family caregivers and the family member with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support and coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. Schizophrenia individuals will be assessed for their symptoms and functioning, quality of life, recovery and rehospitalization. Cost data such as costs of the intervention, health care utilization, and costs associated with lost productivity will also be collected. In addition, we will collect process data including fidelity and quality of program implementation as well as users’ attitudes will also be collected. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling (GLMM) with clusters as a random effect and time as a fixed effect. Cost-effectiveness analysis will be performed from the societal perspective using incremental cost effectiveness ratios (ICERs). Qualitative analysis will use the grounded theory approach and immersion-crystallization process. Results: The study was funded in August 2018, approved by IRB on Jan 15th 2019. Preliminary baseline data collection was conducted in May 2019 and completed in Sep 2019. The WIFI intervention is expected to start in May 2020. Conclusions: This is the first study to test a WeChat-based mHealth intervention to support family caregiving of schizophrenia in China. The innovative study will contribute to the development of a more cost-effective and evidence-based family management model in the community for schizophrenia individuals, and potentially be integrated into national policy and adapted for use with other populations. Clinical Trial: ClinicalTrials.gov registration number to be released soon. Registered on 30 January 2020

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