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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: Image created by the Authors/PlaceIt; Copyright: The Authors/Placeit; URL: http://www.researchprotocols.org/2020/10/e23655/; License: Licensed by JMIR.

    A Mobile Health Intervention (LifeBuoy App) to Help Young People Manage Suicidal Thoughts: Protocol for a Mixed-Methods Randomized Controlled Trial

    Abstract:

    Background: Self-help smartphone apps offer a new opportunity to address youth suicide prevention by improving access to support and by providing potentially high fidelity and cost-effective treatment. However, there have been very few smartphone apps providing evidence-based support for suicide prevention in this population. To address this gap, we developed the LifeBuoy app, a self-help smartphone app informed by dialectical behavior therapy (DBT), to help young people manage suicidal thoughts in their daily life. Objective: This study describes the protocol for a randomized controlled trial to evaluate the efficacy of the LifeBuoy app for reducing suicidal thoughts and behaviors, depression, anxiety, and psychological distress, and improving general mental well-being in young adults aged 18 to 25 years. Methods: This is a randomized controlled trial recruiting 378 young adults aged between 18 and 25 years and comparing the LifeBuoy app with a matched attention control (a placebo app with the same display but no DBT components). The primary outcome is suicidal thoughts measured by the Suicidal Ideation Attributes Scale (SIDAS). The secondary outcomes are suicidal behavior, depression, anxiety, psychological distress, and general mental well-being. The changes in the levels of insomnia, rumination, suicide cognitions, distress tolerance, loneliness, and help seeking before and after using the app are evaluated in this study. The study also addresses risk factors and responses to the intervention. A series of items assessing COVID-19 experiences is included in the trial to capture the potential impact of the pandemic on this study. Assessments will occur on the following three occasions: baseline, postintervention, and follow-up at 3 months postintervention. A qualitative interview about user experience with the LifeBuoy app will take place within 4 weeks of the final assessment. Using linear mixed models, the primary analysis will compare the changes in suicidal thoughts in the intervention condition relative to the control condition. To minimize risks, participants will receive a call from the team clinical psychologist by clicking a help button in the app or responding to an automated email sent by the system when they are assessed with elevated suicide risks at the baseline, postintervention, and 3-month follow-up surveys. Results: The trial recruitment started in May 2020. Data collection is currently ongoing. Conclusions: This is the first trial examining the efficacy of a DBT-informed smartphone app delivered to community-living young adults reporting suicidal thoughts. This trial will extend knowledge about the efficacy and acceptability of app-based support for suicidal thoughts in young people. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001671156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378366.

  • Source: jcomp; Copyright: Freepik; URL: https://www.freepik.com/free-photo/sleeping-woman-her-legs_908453.htm#page=1&query=depression&position=4; License: Licensed by JMIR.

    Repetitive Transcranial Magnetic Stimulation With and Without Internet-Delivered Cognitive-Behavioral Therapy for the Treatment of Resistant Depression:...

    Abstract:

    Background: Major depression is a severe, disabling, and potentially lethal clinical disorder. Only about half of patients respond to an initial course of antidepressant pharmacotherapy. At least 15% of all patients with major depressive disorder (MDD) remain refractory to any treatment intervention. By the time that a patient has experienced 3 definitive treatment failures, the likelihood of achieving remission with the fourth treatment option offered is below 10%. Repetitive transcranial magnetic stimulation (rTMS) is considered a treatment option for patients with MDD who are refractory to antidepressant treatment. It is not currently known if the addition of internet-delivered cognitive-behavioral therapy (iCBT) enhances patients’ responses to rTMS treatments. Objective: This study will evaluate the initial comparative clinical effectiveness of rTMS with and without iCBT as an innovative patient-centered intervention for the treatment of participants diagnosed with treatment-resistant depression (TRD). Methods: This study is a prospective, two-arm randomized controlled trial. In total, 100 participants diagnosed with resistant depression at a psychiatric care clinic in Edmonton, Alberta, Canada, will be randomized to one of two conditions: (1) enrolment in rTMS sessions alone and (2) enrolment in the rTMS sessions plus iCBT. Participants in each group will complete evaluation measures (eg, recovery, general symptomatology, and functional outcomes) at baseline, 1 month, 3 months, and 6 months. The primary outcome measure will be the mean change to scores on the Hamilton Depression Rating Scale. Patient service utilization data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analyzed with descriptive statistics, repeated measures, and correlational analyses. Results: We expect the results of the study to be available in 24 months. We hypothesize that participants enrolled in the study who receive rTMS plus iCBT will achieve superior outcomes in comparison to participants who receive rTMS alone. Conclusions: The concomitant application of psychotherapy with rTMS has not been investigated previously. We hope that this project will provide us with a concrete base of data to evaluate the practical application and efficacy of using a novel combination of these two treatment modalities (rTMS plus iCBT). Trial Registration: ClinicalTrials.gov NCT0423965; https://clinicaltrials.gov/ct2/show/NCT04239651

  • Source: Adobe Stock; Copyright: Daniel Ernst; URL: https://stock.adobe.com/ca/search?load_type=search&native_visual_search=&similar_content_id=&is_recent_search=&search_type=usertyped&k=eye+doctor+black&asset_id=203297858; License: Licensed by JMIR.

    The Technical Feasibility of Integrating Primary Eye Care Into Primary Health Care Systems in Nigeria: Protocol for a Mixed Methods Cross-Sectional Study

    Abstract:

    Background: Approximately 90% of the 253 million blind or visually impaired people worldwide live in low- and middle-income countries. Lack of access to eye care is why most people remain or become blind. The World Health Organization Regional Office for Africa (WHO-AFRO) recently launched a primary eye care (PEC) package for sub-Saharan Africa—the WHO-AFRO PEC package—for integration into the health system at the primary health care (PHC) level. This has the potential to increase access to eye care, but feasibility studies are needed to determine the extent to which the health system has the capacity to deliver the package in PHC facilities. Objective: Our objective is to assess the technical feasibility of integrating the WHO-AFRO PEC package in PHC facilities in Nigeria. Methods: This study has several components, which include (1) a literature review of PEC in sub-Saharan Africa, (2) a Delphi exercise to reach consensus among experts regarding the technical complexity of the WHO-AFRO PEC package and the capacities needed to deliver it in PHC facilities, (3) development of PEC technical capacity assessment tools, and (4) data collection, including facility surveys and semistructured interviews with PHC staff and their supervisors and village health workers to determine the capacities available to deliver PEC in PHC facilities. Analysis will identify opportunities and the capacity gaps that need to be addressed to deliver PEC. Results: Consensus was reached among experts regarding the technical complexity of the WHO-AFRO PEC package and the capacities needed to deliver it as part of PHC. Quantitative tools (ie, structured questionnaires, in-depth interviews, and observation checklists) and topic guides based on agreed-upon technical capacities have been developed and relevant stakeholders have been identified. Surveys in 48 PHC facilities and interviews with health professionals and supervisors have been undertaken. Capacity gaps are being analyzed. Conclusions: This study will determine the capacity of PHC centers to deliver the WHO-AFRO PEC package as an integral part of the health system in Nigeria, with identification of capacity gaps. Although capacity assessments have to be context specific, the tools and findings will assist policy makers and health planners in Nigeria and similar settings, who are considering implementing the package, in making informed choices.

  • Source: Istock; Copyright: fizkes; URL: https://stock.adobe.com/ca/search?load_type=search&native_visual_search=&similar_content_id=&is_recent_search=&search_type=usertyped&k=Close+up+older+man+talking+with+doctor+by+video+call%2C+using+medical+apps+on+laptop&asset_id=332624365; License: Licensed by JMIR.

    Video Consultations for Older Adults With Multimorbidity During the COVID-19 Pandemic: Protocol for an Exploratory Qualitative Study

    Abstract:

    Background: Multimorbidity, the coexistence of multiple chronic conditions in an individual, is a growing public health challenge. Amidst the COVID-19 pandemic, physical distancing remains an indispensable measure to limit the spread of the virus. This pertains especially to those belonging to high-risk groups, namely older adults with multimorbidity. In-person visits are discouraged for this cohort; hence, there is a need for an alternative form of consultation such as video consultations to continue the provision of care. Objective: The potential of video consultations has been explored in several studies. However, the emergence of COVID-19 presents us with an unprecedented opportunity to explore the use of this technological innovation in a time when physical distancing is imperative. This study will evaluate the sustainability of video consultations on a micro-, meso-, and macro-level by assessing the views of patients, physicians, and organizational and national policymakers, respectively. Methods: The NASSS (nonadoption, abandonment, scale-up, spread, and sustainability) framework was designed as a guide for the development of health care technologies. In this study, the implementation of and experiences related to video consultations will be studied using the NASSS framework. Individual in-depth interviews or focus group discussions will be conducted with participants using the Zoom platform. Data will be analyzed by at least two investigators trained in qualitative methodology, organized thematically, and coded in two phases—an initial phase and a focused selective phase. All disagreements will be resolved by consulting the larger research team until consensus is reached. Results: This study was approved for funding from the Geriatric Education and Research Institute. Ethics approval was obtained from the National Healthcare Group Domain Specific Review Board (reference #2020/00760). Study recruitment commenced in July 2020. The results of the data analysis are expected to be available by the end of the year. Conclusions: This study aims to evaluate the adoption and sustainability of video consultations for older adults with multimorbidity during the pandemic as well as post COVID-19. The study will yield knowledge that will challenge the current paradigm on how care is being delivered for community-dwelling older adults with multimorbidity. Findings will be shared with administrators in the health care sector in order to enhance the safety and quality of these video consultations to improve patient care for this group of population.

  • Older active couple  representing healthy aging phenotype. Source: iStock.com; Copyright: yacobchuck; URL: https://www.istockphoto.com/photo/joyful-woman-feeling-happiness-while-cycling-gm828372446-134803005?clarity=false; License: Licensed by the authors.

    A Biological Age Model Designed for Health Promotion Interventions: Protocol for an Interdisciplinary Study for Model Development

    Abstract:

    Background: Actions to improve healthy aging and delay morbidity are crucial, given the global aging population. We believe that biological age estimation can help promote the health of the general population. Biological age reflects the heterogeneity in functional status and vulnerability to disease that chronological age cannot. Thus, biological age assessment is a tool that provides an intuitively meaningful outcome for the general population, and as such, facilitates our understanding of the extent to which lifestyle can increase health span. Objective: This interdisciplinary study intends to develop a biological age model and explore its usefulness. Methods: The model development comprised three consecutive phases: (1) conducting a cross-sectional study to gather candidate biomarkers from 100 individuals representing normal healthy aging people (the derivation cohort); (2) estimating the biological age using principal component analysis; and (3) testing the clinical use of the model in a validation cohort of overweight adults attending a lifestyle intervention course. Results: We completed the data collection and analysis of the cross-sectional study, and the initial results of the principal component analysis are ready. Interpretation and refinement of the model is ongoing. Recruitment to the validation cohort is forthcoming. We expect the results to be published by December 2021. Conclusions: We expect the biological age model to be a useful indicator of disease risk and metabolic risk, and further research should focus on validating the model on a larger scale. Trial Registration: ClinicalTrials.gov NCT03680768, https://clinicaltrials.gov/ct2/show/NCT03680768 (Phase 1 study); NCT04279366 https://clinicaltrials.gov/ct2/show/NCT04279366 (Phase 3 study).

  • LiverMultiScan image analysis. Source: Image created by the Authors; Copyright: The Authors (Perspectum Ltd); URL: http://www.researchprotocols.org/2020/10/e19189/; License: Creative Commons Attribution (CC-BY).

    The Effect of Multi-Parametric Magnetic Resonance Imaging in Standard of Care for Nonalcoholic Fatty Liver Disease: Protocol for a Randomized Control Trial

    Abstract:

    Background: The rising prevalence of nonalcoholic fatty liver disease (NAFLD) and the more aggressive subtype, nonalcoholic steatohepatitis (NASH), is a global public health concern. Left untreated, NAFLD/NASH can lead to cirrhosis, liver failure, and death. The current standard for diagnosing and staging liver disease is a liver biopsy, which is costly, invasive, and carries risk for the patient. Therefore, there is a growing need for a reliable, feasible, and cost-effective, noninvasive diagnostic tool for these conditions. LiverMultiScan is one such promising tool that uses multi-parametric magnetic resonance imaging (mpMRI) to characterize liver tissue and to aid in the diagnosis and monitoring of liver diseases of various etiologies. Objective: The primary objective of this trial (RADIcAL1) is to evaluate the cost-effectiveness of the introduction of LiverMultiScan as a standardized diagnostic test for liver disease in comparison to standard care for NAFLD, in different EU territories. Methods: RADIcAL1 is a multi-center randomized control trial with 2 arms conducted in 4 European territories (13 sites, from across Germany, Netherlands, Portugal, and the United Kingdom). In total, 1072 adult patients with suspected fatty liver disease will be randomized to be treated according to the result of the mpMRI in the intervention arm, so that further diagnostic evaluation is recommended only when values for metrics of liver fat or fibro-inflammation are elevated. Patients in the control arm will be treated as per center guidelines for standard of care. The primary outcome for this trial is to compare the difference in the proportion of patients with suspected NAFLD incurring liver-related hospital consultations or liver biopsies between the study arms, from the date of randomization to the end of the study follow-up. Secondary outcomes include patient feedback from a patient satisfaction questionnaire, at baseline and all follow-up visits to the end of the study, and time, from randomization to diagnosis by the physician, as recorded at the final follow-up visit. Results: This trial is currently open for recruitment. The anticipated completion date for the study is December 2020. Conclusions: This randomized controlled trial will provide the evidence to accelerate decision making regarding the inclusion of mpMRI-based tools in existing NAFLD/NASH clinical care. RADIcAL1 is among the first and largest European health economic studies of imaging technologies for fatty liver disease. Strengths of the trial include a high-quality research design and an in-depth assessment of the implementation of the cost-effectiveness of the mpMRI diagnostic. If effective, the trial may highlight the health economic burden on tertiary-referral hepatology clinics imposed by unnecessary consultations and invasive diagnostic investigations, and demonstrate that including LiverMultiScan as a NAFLD diagnostic test may be cost-effective compared to liver-related hospital consultations or liver biopsies. Trial Registration: ClinicalTrials.gov NCT03289897 https://clinicaltrials.gov/ct2/show/NCT03289897

  • Source: Unsplash; Copyright: National Cancer Institute; URL: https://unsplash.com/photos/odggKTyA5o0; License: Licensed by JMIR.

    Safety and Biovigilance in Organ Donation (SAFEBOD): Protocol for a Population-Based Cohort Study

    Abstract:

    Background: Tension lies between the need to increase access to organ transplantation and the equally urgent need to prevent inadvertent transmission of infectious diseases or cancer from organ donors. Biovigilance, or the evaluation of potential donors, is often time-pressured and may be based on incomplete information. Objective: The Safety and Biovigilance in Organ Donation (SAFEBOD) study aims to improve estimates of infection and cancer transmission risk and explore how real-time data access could support decision-making. Methods: We will link existing donor referral, actual donor, recipient, and health-outcome data sets from 2000-2015 in New South Wales. Organ donor data sets will include the Organ Donor Characterizing Risk-Profile of Donors Study, the National Organ Matching System, the Australian and New Zealand Organ Donor Register, and the Australian and New Zealand Living Donor Kidney Register. Recipient data sets will include the Australian and New Zealand Dialysis and Transplant Register, the Australian and New Zealand Cardiothoracic Register, the Australian and New Zealand Islet and Pancreas Register, and the Australian and New Zealand Liver Transplant Register. New South Wales health outcome data sets will include HIV and AIDS Notifications and Surveillance Data, the Notifiable Conditions Information Management System, Admitted Patient Data Collection, Emergency Department Data Collection, the Central Cancer Registry, and the Cause of Death Data Collection. We will link organ donors to transplant recipients and health outcomes data sets using probabilistic data-matching based on personal identifiers. Transmission and nontransmission events will be determined by comparing previous cases in donors and posttransplant cases in recipients. We will compare the perceived-risk at referral with the verified risk from linked health outcome data sets and the odds of cancer or contracting an infectious disease in organ recipients from donors based on their transmission-risk profile and estimate recipient survival by donor transmission risk group. Results: Data were requested from each of the listed registries in September 2018, and data collection is ongoing. Linked data from all listed data sets are expected to be complete in September 2020. Conclusions: The SAFEBOD study will overcome current limitations in organ donation by accessing comprehensive information on referred organ donors and recipients in existing data sets. The study will provide robust estimates of disease transmission and nontransmission events based on recent data. It will also describe the agreement between perceived risk estimated at the time of referral and verified risk when all health outcome data are accessible. The improved understanding of transmission and nontransmission events will inform clinical decisions and highlight where current policies can be revised to broaden the acceptance of deceased donors. Trial Registration:

  • Source: Image created by the authors; Copyright: Victor Dourado; URL: https://www.youtube.com/watch?v=VLU2BXGYyoM; License: Creative Commons Attribution (CC-BY).

    Use of a Smartphone App to Increase Physical Activity Levels in Insufficiently Active Adults: Feasibility Sequential Multiple Assignment Randomized Trial...

    Abstract:

    Background: The sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity. Objective: We aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants’ perception regarding the protocol and the use of the app for physical activity qualitatively. Methods: We conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention. Results: Twelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median −198 steps/day [IQR −279 to −103] to 20 steps/day [IQR −204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants’ reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals. Conclusions: The SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones. Trial Registration: Brazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/group-beautiful-women-posing-together_6651928.htm#page=1&query=women%20group&position=27; License: Licensed by JMIR.

    Qualitative Evidence Synthesis on Self-Collection for Human Papillomavirus–Based Cervical Screening: Protocol for Systematic Review

    Abstract:

    Background: Cervical cancer is the fourth most common cancer affecting women worldwide. In the 1980s, it was found that the sexually transmitted disease human papillomavirus causes over 90% of all cervical cancer cases. Since that discovery, diagnostic technologies have been developed for the detection of human papillomavirus DNA in cervical samples. However, significant sociocultural and structural barriers remain. Considerable strides have taken place in recent years to address these barriers, such as the self-collection for human papillomavirus–based cervical screening method. Objective: The purpose of this review is to synthesize qualitative evidence around the self-collection method and identify strategies to increase acceptability and feasibility in different settings. This qualitative synthesis will be used to better understand how to conceptualize and implement more effective, accessible, and socially and culturally acceptable cervical screening programs and policies globally. Methods: A systematic search will be conducted in Global Health, Cochrane, CINAHL (Cumulative Index to Nursing and Allied Health Literature), ProQuest, ScienceDirect, EMBASE, EMCARE, Medline (OVID), Scopus, and Web of Science. Published and peer-reviewed articles will be included. Two reviewers will independently screen and assess the studies. The data will be coded and analyzed using a thematic synthesis process. The socioecological model will be used to organize emergent themes at the micro and macro levels. The results will be presented in narrative and tabular form. Results: The article search and data extraction were completed in May 2020. The data were analyzed in June 2020. The review will be submitted for publication in Fall 2020. Conclusions: This review will present the global evidence of the perspectives and experiences of various key stakeholders and how these perspectives and experiences impact their decision-making process to perform or accept self-collection for human papillomavirus–based cervical screening. The review will provide guidance to implementation researchers as well as implications for future research. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019109073; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=109073

  • CAir Desk with sensors. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/10/e20412/; License: Creative Commons Attribution (CC-BY).

    A Telemonitoring and Hybrid Virtual Coaching Solution “CAir” for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized...

    Abstract:

    Background: Chronic obstructive pulmonary disease (COPD) is one of the most common disorders in the world. COPD is characterized by airflow obstruction, which is not fully reversible. Patients usually experience breathing-related symptoms with periods of acute worsening and a substantial decrease in the health-related quality-of-life. Active and comprehensive disease management can slow down the progressive course of the disease and improve patients’ disabilities. Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention. Objective: This study aims to develop a comprehensive telemonitoring and hybrid virtual coaching solution and to investigate its effects on the health-related quality of life of patients with COPD. Methods: A monocentric, assessor-blind, two-arm (intervention/control) randomized controlled trial will be performed. Participants randomized to the control group will receive usual care and a CAir Desk (custom-built home disease-monitoring device to telemonitor disease-relevant parameters) for 12 weeks, without feedback or scores of the telemonitoring efforts and virtual coaching. Participants randomized to the intervention group will receive a CAir Desk and a hybrid digital coaching intervention for 12 weeks. As a primary outcome, we will measure the delta in the health-related quality of life, which we will assess with the St. George Respiratory Questionnaire, from baseline to week 12 (the end of the intervention). Results: The development of the CAir Desk and virtual coach has been completed. Recruitment to the trial started in September 2020. We expect to start data collection by December 2020 and expect it to last for approximately 18 months, as we follow a multiwave approach. We expect to complete data collection by mid-2022 and plan the dissemination of the results subsequently. Conclusions: To our knowledge, this is the first study investigating a combination of telemonitoring and hybrid virtual coaching in patients with COPD. We will investigate the effectiveness, efficacy, and usability of the proposed intervention and provide evidence to further develop app-based and chatbot-based disease monitoring and interventions in COPD. Trial Registration: ClinicalTrials.gov identifier: NCT04373070; https://clinicaltrials.gov/ct2/show/NCT04373070

  • Source: freepik; Copyright: wavebreakmedia_micro; URL: https://www.freepik.com/free-photo/male-surgeon-using-digital-tablet-operation-room_8402174.htm#page=1&query=doctor%20using%20computer&position=3; License: Licensed by JMIR.

    Understanding the Uptake of Big Data in Health Care: Protocol for a Multinational Mixed-Methods Study

    Abstract:

    Background: Despite the high potential of big data, their applications in health care face many organizational, social, financial, and regulatory challenges. The societal dimensions of big data are underrepresented in much medical research. Little is known about integrating big data applications in the corporate routines of hospitals and other care providers. Equally little is understood about embedding big data applications in daily work practices and how they lead to actual improvements for health care actors, such as patients, care professionals, care providers, information technology companies, payers, and the society. Objective: This planned study aims to provide an integrated analysis of big data applications, focusing on the interrelations among concrete big data experiments, organizational routines, and relevant systemic and societal dimensions. To understand the similarities and differences between interactions in various contexts, the study covers 12 big data pilot projects in eight European countries, each with its own health care system. Workshops will be held with stakeholders to discuss the findings, our recommendations, and the implementation. Dissemination is supported by visual representations developed to share the knowledge gained. Methods: This study will utilize a mixed-methods approach that combines performance measurements, interviews, document analysis, and cocreation workshops. Analysis will be structured around the following four key dimensions: performance, embedding, legitimation, and value creation. Data and their interrelations across the dimensions will be synthesized per application and per country. Results: The study was funded in August 2017. Data collection started in April 2018 and will continue until September 2021. The multidisciplinary focus of this study enables us to combine insights from several social sciences (health policy analysis, business administration, innovation studies, organization studies, ethics, and health services research) to advance a holistic understanding of big data value realization. The multinational character enables comparative analysis across the following eight European countries: Austria, France, Germany, Ireland, the Netherlands, Spain, Sweden, and the United Kingdom. Given that national and organizational contexts change over time, it will not be possible to isolate the factors and actors that explain the implementation of big data applications. The visual representations developed for dissemination purposes will help to reduce complexity and clarify the relations between the various dimensions. Conclusions: This study will develop an integrated approach to big data applications that considers the interrelations among concrete big data experiments, organizational routines, and relevant systemic and societal dimensions.

  • Source: Pexels; Copyright: Anna Shvets; URL: https://www.pexels.com/photo/person-holding-white-printer-paper-4226124/; License: Licensed by JMIR.

    Respiratory Health of Pacific Youth: An Observational Study of Associated Risk and Protective Factors Throughout Childhood

    Abstract:

    Background: Respiratory disease is the third most common cause of death in New Zealand, with Pacific people living in New Zealand bearing the greatest burden of this type of disease. Although some epidemiological outcomes are known, we lack the specifics required to formulate targeted and effective public health interventions. The Pacific Islands Families (PIF) birth cohort study is a study that provides a unique source of data to assess lung function and current respiratory health among participants entering early adulthood and to examine associations with early life events during critical periods of growth. Objective: This paper aims to provide an overview of the design, methods, and scope of the Respiratory Health of Pacific Youth Study, which uses the overall PIF study cohort aged 18-19 years. Methods: From 2000-2019, the PIF study has followed, from birth, the growth, and the development of 1398 Pacific children born in Auckland, New Zealand. Participants were nested within the overall PIF study (at ages 18-19 years) from June 2018, and assessments were undertaken until mid-November 2019. The assessments included respiratory and general medical histories, a general physical examination, assessment of lung function (forced expiratory volume and forced vital capacity), self-completed questionnaires (St George’s Respiratory Questionnaire, European Quality of Life 5 Dimensions-3 Level, Epworth Sleepiness Scale for Children and Adolescents, and Leicester Cough Questionnaire), blood tests (eosinophils, Immunoglobulin E, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and C-reactive protein), and chest x-rays. Noninferential analyses will be carried out on dimensionally reduced risk and protective factors and confounders. Results: Data collection began in June 2018 and ended in November 2019, with a total of 466 participants recruited for submission of the paper. Collection and collation of chest x-ray data is still underway, and data analysis and expected results will be published by November 2020. Conclusions: This is the first longitudinal observational study to address the burden of respiratory disease among Pacific youth by determining factors in early life that impose long-term detriments in lung function and are associated with the presence of respiratory illness. Identifying risk factors and the magnitude of their effects will help in adopting preventative measures, establishing whether any avoidable risks can be modified by later resilient behaviors, and provide baseline measurements for the development of respiratory disease in later adult life. The study results can be translated into practice guidelines and inform health strategies with immediate national and international impact.

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    Date Submitted: Oct 22, 2020

    Open Peer Review Period: Oct 22, 2020 - Dec 17, 2020

    Background: The impact of the COVID-19 pandemic has gone far beyond the direct overload of the hospital care system, with physical distancing, financial uncertainty, and the stress of well-being havin...

    Background: The impact of the COVID-19 pandemic has gone far beyond the direct overload of the hospital care system, with physical distancing, financial uncertainty, and the stress of well-being having largely negative consequences on individuals’ mental health. Adding to these stressors is the personal and public trauma of lost lives, with an increasing fear of an unprecedented mental health epidemic with crushing effects on the public health sector and economy. To meet this overwhelming and growing demand for mental health care on an already strained health care system, we must have innovative approaches to significantly expand the capacity of care delivery. While it is not feasible in the short term to increase the number of mental health care providers or the number of hours they work, improving their time efficiency may be a viable solution. Virtual care and online delivery of psychotherapy, shown to be clinically effective, efficient, and cost-effective, presents itself as a promising means to address the ever-growing demand for mental health care. To our knowledge, we have established the first academic online psychotherapy clinic that aims to manage mental health problems secondary to the COVID-19 pandemic. Objective: The goal of this research protocol is to evaluate the feasibility and efficacy of treating mental health issues aggravated by the stressors associated with the COVID-19 pandemic through an online platform. Methods: This non-randomized control trial intervention will be delivered through the Online Psychotherapy Tool (OPTT), a secure, cloud-based, digital mental health platform. Participants will be offered a 9-week, diagnosis-specific, online cognitive behavioural therapy (e-CBT) program tailored to address mental health problems in the context of the COVID-19 pandemic. Participants (n = 80) will receive personalized feedback and interaction with a therapist throughout the program. Results: The study received ethics approval in June 2020, and the recruitment of participants began in June 2020. Participant recruitment is being conducted via social media, web-based communities, and physician referrals. Data collection is expected to conclude by November 2020, and analyses are expected to be completed by December 2020 with linear regression analysis (for continuous outcomes) and binomial regression analysis (for categorical outcomes) being conducted. Conclusions: If proven feasible, this method of care delivery could increase care capacity by four-folds. The findings from this project have the potential to influence clinical practice and policy and increase accessibility to care during the COVID-19 pandemic, without sacrificing the quality of care. Clinical Trial: ClinicalTrials.Gov Protocol Registration and Results System (NCT0446667); https://clinicaltrials.gov/ct2/show/NCT04476667.

  • Chest CT and rapid antigen testing for reducing the risk of COVID-19 infection among HCWs involved in emergency trauma surgery during the pandemic: a systematic review protocol

    Date Submitted: Oct 24, 2020

    Open Peer Review Period: Oct 22, 2020 - Dec 17, 2020

    Background: Many healthcare facilities in low-and middle-income countries are inadequately resourced and may lack optimal organization and governance, especially concerning surgical health systems. CO...

    Background: Many healthcare facilities in low-and middle-income countries are inadequately resourced and may lack optimal organization and governance, especially concerning surgical health systems. COVID-19 has the potential to decimate these already strained surgical healthcare services unless health systems take stringent measures to protect healthcare workers (HCWs) from viral exposure and ensure the continuity of specialized care for the patients. Objective: This systematic review aims to identify and summarize the available literature regarding the efficacy of chest CT and rapid testing for emergency trauma surgery patients to reduce the risk of COVID-19 infection in trauma surgery staff in low-resource environments (LREs). Methods: We will conduct several searches in the L·OVE (Living OVerview of Evidence) platform for COVID-19, a system that performs automated regular searches in PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and over thirty other sources. The search results will be presented according to the PRISMA flow diagram. This review will preferentially consider systematic reviews of experimental and quasi-experimental studies, as well as individual studies of such designs, evaluating the effect of chest CT and rapid testing for emergency trauma surgery patients in preventing COVID-19 infection in emergency trauma surgery staff. Critical appraisal of the eligible studies for methodological quality will be conducted. Data will be extracted using the standardized data extraction tool in Covidence. Studies will, when possible, be pooled in a statistical meta-analysis using JBI SUMARI. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for grading the certainty of evidence will be followed, and a Summary of Findings (SoF) will be created. Results: Ethics approval is not required for this systematic review, as there will be no patient involvement. The search for this systematic review commenced in October 2020, and we expect to publish the findings in early 2021. The plan for dissemination is to publish review findings in a peer-reviewed journal and present findings at high-level conferences that engage the most pertinent stakeholders. Conclusions: In the era of the COVID-19, where protecting HCWs from infection is essential, up-to-date information on diagnostic capabilities and efficacy for COVID-19 infection is essential. This review will serve an important role as a repository of available evidence for the purpose of setting effective policy and clinical guideline recommendations. Clinical Trial: International Prospective Register of Systematic Reviews (PROSPERO) CRD42020198267; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=198267

  • Technology—supported guidance models stimulating the development of critical thinking in clinical practice: A mixed methods systematic review protocol

    Date Submitted: Oct 19, 2020

    Open Peer Review Period: Oct 19, 2020 - Dec 14, 2020

    Background: Critical thinking is an essential skill that nursing students need to develop. Critical thinking is developed through guidance in clinical practice. Technological tools have opened new ave...

    Background: Critical thinking is an essential skill that nursing students need to develop. Critical thinking is developed through guidance in clinical practice. Technological tools have opened new avenues for technology–supported guidance that stimulates the development of nursing students` critical thinking, but it is unclear which technology–supported guidance models are being used to stimulate the development of critical thinking and what are the challenges and facilitators of such guidance models. Objective: The aim of this study is synthesize the available knowledge on the use of technology–supported guidance models in nursing clinical practice that stimulates the development of critical thinking. Methods: Mixed methods systematic review by using a convergent integrated design following the Joanna Briggs Institute Manual for Evidence Synthesis. Articles will be selected by screening the titles and abstracts by a pair of authors. The methodological quality of articles will be assessed by a pair of authors, according to checklists for specific study designs. Data then will be extracted through a standardised Joanna Briggs Institute Mixed Methods Data Extraction Form Following a Convergent Integrated Approach. The thematic synthesis for data transformation and synthesis will be used. Results: Results of this review are expected in January 2021. Conclusions: By combining evidence from studies with varied methodological approaches, it is expected that there will be a broader insight into the use of technology–supported guidance models in clinical practice, in nursing education, with focus on the development of nursing students` critical thinking. Clinical Trial: This protocol is not a protocol of clinical trial.

  • The Association between a Low Carbohydrate Diet, Quality of Life and Glycemic Control in Australian Adults living with Type 1 Diabetes: A Pilot Study Protocol

    Date Submitted: Oct 16, 2020

    Open Peer Review Period: Oct 16, 2020 - Dec 11, 2020

    Background: Globally, the prevalence of type 1 diabetes (T1DM) is rising. In 2020, 124,652 Australians had T1DM. Maintaining optimal glycemic control [HbA1c ≤7.0% (≤53 mmol/mol)] on a standard car...

    Background: Globally, the prevalence of type 1 diabetes (T1DM) is rising. In 2020, 124,652 Australians had T1DM. Maintaining optimal glycemic control [HbA1c ≤7.0% (≤53 mmol/mol)] on a standard carbohydrate diet can be a challenge for people living with T1DM. The Diabetes Complications and Control Trial established that macrovascular and microvascular complications could be reduced by improving glycemic control. Recent studies have found that a very low or low carbohydrate diet can improve glycemic control. However, the overall evidence relating to an association between a very low or low carbohydrate diet and glycemic control in people living with T1DM is both limited and mixed. In addition, research has suggested that poor quality of life (QoL) due to anxiety and depression adversely influences glycemic control. Despite a potential link between a very low or low carbohydrate diet and good glycemic control, no research to our knowledge has examined an association between a very low or low carbohydrate diet, QoL and glycemic control, making this study unique in its approach. Objective: The study aims to: 1) develop a validated diabetes specific quality of life questionnaire for use in Australian adults with T1DM and 2) determine if an association exists between a low carbohydrate diet, quality of life and glycemic control in Australian adults living with T1DM. Methods: This cross-sectional study will be conducted in a tertiary hospital outpatient setting and will consist of three phases. Phase 1, online Australian diabetes specific quality of life questionnaire development and piloting (n=25-30 T1DM adults); Phase 2, questionnaire validation (n=364 T1DM adults) and Phase 3, a 12-week dietary intervention to determine if an association exists between a low carbohydrate diet, QoL and glycemic control in adults with T1DM (n=16-23 T1DM adults). The validation of the study developed Australian diabetes specific quality of life questionnaire and change in HbA1c and QoL in adults with T1DM while undertaking a low carbohydrate diet over 12 weeks will be the primary outcomes of this study. Results: Results: Study phase 1 is currently open for recruitment. It is anticipated the first results will be submitted for publication in November 2021. Presently, no results are available. Conclusions: This study is the first of its kind and will firstly generate a new validated instrument, which could be used in evidence-based practice and research to understand T1DM adults QoL. Secondly, the low carbohydrate dietary intervention outcomes could be used to inform clinicians about an alternative approach to assist T1DM Australian adults to improve their QoL and glycemic control. Finally, this study could warrant the development of an evidence based low carbohydrate dietary guideline for adults living with T1DM with the potential to have a profound impact on this population. Clinical Trial: ClinicalTrials.gov NCT04213300; https://www.clinicaltrials.gov/ct2/show/NCT04213300

  • XatJove Anoia, as a tool to bring health services closer to teenagers: A quasi-experimental study

    Date Submitted: Oct 16, 2020

    Open Peer Review Period: Oct 16, 2020 - Dec 11, 2020

    Background: The Catalan Health and School program aims to improve the health of adolescents through health promotion measures, risk prevention and early care for problems related to mental health, emo...

    Background: The Catalan Health and School program aims to improve the health of adolescents through health promotion measures, risk prevention and early care for problems related to mental health, emotional and sexual health and the consumption of drugs, alcohol and tobacco. Adolescents are often reluctant to seek counseling and/or health treatment for “embarrassing” or stigmatized conditions. As an anonymous digital health intervention, XatJove has the potential to address this problem. In the current climate of a health crisis caused by the COVID-19 pandemic and in an attempt to reduce the risk of infection, it makes more sense than ever to try to avoid face-to-face consultations with nursing staff in schools and also visits by young people to Primary Care Centres using digital health interventions. Objective: The objective of this study is to demonstrate that the use of mobile phones and messaging apps increases the number of health consultations as part of the Health and School program in the Anoia region in Catalonia. Methods: A quasi-experimental study of adolescents aged between 12 and 16 from secondary schools, comparing the total number of consultations (face-to-face and via XatJove) as part of the Health and School program in the Anoia region during the 2020-2021 academic year with the number of face-to-face consultations as part of the same program in the Osona region. Students will be asked to participate in a follow up study involving a focus group to learn more about the usefulness of XatJove. Results: The study is projected to start at the beginning of November 2020 and its will finish in June 2021 when data analysis is expected to start. Conclusions: The results could be of help in the evaluation, development and planning of school health programs. Clinical Trial: NCT04562350 (Registration data September 24, 2020)

  • Physical activity, nutritional habits and sleeping behavior in health professions students and employees of a Swiss University of Applied Sciences during the COVID-19 period: A protocol for a questionnaire survey study

    Date Submitted: Oct 20, 2020

    Open Peer Review Period: Oct 15, 2020 - Dec 10, 2020

    Background: A new coronavirus SARS-CoV-2 led to the COVID-19 pandemic since January 2020. To block the transmission of the virus, the Swiss Federal Council decided for a lockdown of the non-essential...

    Background: A new coronavirus SARS-CoV-2 led to the COVID-19 pandemic since January 2020. To block the transmission of the virus, the Swiss Federal Council decided for a lockdown of the non-essential businesses. Students and employees of institutions for higher education were informed to install home-office and online lectures. Objective: The aim of this longitudinal survey will be to evaluate lifestyle habits such as physical activity, nutritional habits and sleeping behavior 1) during a two months period of confinement and social distancing and 2) one year after the COVID-19 pandemic time period in students and employees of a Swiss University of Applied Sciences. Methods: This manuscript describes a protocol for a retrospective and prospective observational cohort study. Students and employees from the Bern University of Applied Sciences – Department of Health Professions (BFH-DHP) will be invited to complete an anonymous online survey during the COVID-19 confinement period, followed by a second survey scheduled one year after the lockdown. Information on the lifestyle dimensions physical activity, nutrition and sleep will be gathered using adaptations of validated questionnaires. Results: - Conclusions: This survey will give information about the impact of confinement during the COVID-19 crisis on physical activity, nutrition and sleep behavior in students and employees of BFH-DHP. Clinical Trial: ClinicalTrials.gov: NCT04502108

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