Background: Health measurement guides policies and health care decisions are necessary to describe and attain the quintuple aim of improving patient experience, population health, care team well-being, health care costs, and equity. In the primary care setting, patient-reported outcome measurement allows outcome comparisons within and across settings and helps improve the clinical management of patients. However, these digital patient-reported outcome measures (PROMs) are still not adapted to the clinical context of primary health care, which is an indication of the complexity of integrating these tools in this context. We must then gather evidence of their impact on chronic disease management in primary health care and understand the characteristics of effective implementation. Objective: We will conduct a systematic review to identify and assess the impact of electronic PROMs (ePROMs) implementation in primary health care for chronic disease management. Our specific objectives are to (1) determine the impact of ePROMs in primary health care for chronic disease management and (2) compare and contrast characteristics of effective ePROMs’ implementation strategies. Methods: We will conduct a systematic review of the literature in accordance with the guidelines of the Cochrane Methods Group and in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for its reporting. A specific search strategy was developed for relevant databases to identify studies. Two reviewers will independently apply the inclusion criteria using full texts and will extract the data. We will use a 2-phase sequential mixed methods synthesis design by conducting a qualitative synthesis first, and use its results to perform a quantitative synthesis. Results: This study was initiated in June 2022 by assembling the research team and the knowledge transfer committee. The preliminary search strategy will be developed and completed in September 2022. The main search strategy, data collection, study selection, and application of inclusion criteria were completed between October and December 2022. Conclusions: Results from this review will help support implementation efforts to accelerate innovations and digital adoption for primary health care and will be relevant for improving clinical management of chronic diseases and health care services and policies. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022333513; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=333513

Background: Patients with colorectal cancer (CRC) receiving chemotherapy often experience psychoneurological symptoms (PNS; ie, fatigue, depression, anxiety, sleep disturbance, pain, and cognitive dysfunction) that negatively impact both patients’ and their caregivers’ health outcomes. Limited information is available on PNS management for CRC patient and caregiver dyads. Objective: The purposes of this study are to (1) develop a web-based dyadic intervention for patients with CRC receiving chemotherapy and their caregivers (CRCweb) and (2) evaluate the feasibility, acceptability, and preliminary effects of CRCweb among patient-caregiver dyads in a cancer clinic. Methods: A mixed methods approach will be used. Semistructured interviews among 8 dyads will be conducted to develop CRCweb. A single-group pre- and posttest clinical trial will be used to examine the feasibility, acceptability, and preliminary effects of the intervention (CRCweb) among 20 dyads. Study assessments will be conducted before (T1) and after intervention (T2). Content analysis will be performed for semistructured interviews. Descriptive statistics will be calculated separately for patients and caregivers, and pre-post paired t tests will be used to evaluate treatment effects. Results: This study was funded in November 2022. As of April 2023, we have obtained institutional review board approval and completed clinical trial registration and are currently recruiting patient-caregiver dyads in a cancer clinic. The study is expected to be completed in October 2024. Conclusions: Developing a web-based dyadic intervention holds great promise to reduce the PNS burden in patients with CRC receiving chemotherapy and their caregivers. The findings from this study will advance intervention development and implementation of symptom management and palliative care for patients with cancer and their caregivers. Trial Registration: ClinicalTrials.gov NCT05663203; https://clinicaltrials.gov/ct2/show/NCT05663203

Background: Telemonitoring of activities of daily living (ADLs) offers significant potential for gaining a deeper insight into the home care needs of older adults experiencing cognitive decline, particularly those living alone. In 2016, our team and a health care institution in Montreal, Quebec, Canada, sought to test this technology to enhance the support provided by home care clinical teams for older adults residing alone and facing cognitive deficits. The Support for Seniors’ Autonomy program (SAPA [Soutien à l’autonomie des personnes âgées]) project was initiated within this context, embracing an innovative research approach that combines action research and design science. Objective: This paper presents the research protocol for the SAPA project, with the aim of facilitating the replication of similar initiatives in the future. The primary objectives of the SAPA project were to (1) codevelop an ADL telemonitoring system aligned with the requirements of key stakeholders, (2) deploy the system in a real clinical environment to identify specific use cases, and (3) identify factors conducive to its sustained use in a real-world setting. Given the context of the SAPA project, the adoption of an action design research (ADR) approach was deemed crucial. ADR is a framework for crafting practical solutions to intricate problems encountered in a specific organizational context. Methods: This project consisted of 2 cycles of development (alpha and beta) that involved cyclical repetitions of stages 2 and 3 to develop a telemonitoring system for ADLs. Stakeholders, such as health care managers, clinicians, older adults, and their families, were included in each codevelopment cycle. Qualitative and quantitative data were collected throughout this project. Results: The first iterative cycle, the alpha cycle, took place from early 2016 to mid 2018. The first prototype of an ADL telemonitoring system was deployed in the homes of 4 individuals receiving home care services through a public health institution. The prototype was used to collect data about care recipients’ ADL routines. Clinicians used the data to support their home care intervention plan, and the results are presented here. The prototype was successfully deployed and perceived as useful, although obstacles were encountered. Similarly, a second codevelopment cycle (beta cycle) took place in 3 public health institutions from late 2018 to late 2022. The telemonitoring system was installed in 31 care recipients’ homes, and detailed results will be presented in future papers. Conclusions: To our knowledge, this is the first reported ADR project in ADL telemonitoring research that includes 2 iterative cycles of codevelopment and deployment embedded in the real-world clinical settings of a public health system. We discuss the artifacts, generalization of learning, and dissemination generated by this protocol in the hope of providing a concrete and replicable example of research partnerships in the field of digital health in cognitive aging.

Background: It is predicted that digital health technologies that incorporate artificial intelligence will transform health care delivery in the next decade. Little research has explored how emerging trends in artificial intelligence–driven digital health technologies may influence the relationship between nurses and patients. Objective: The purpose of this scoping review is to summarize the findings from 4 research questions regarding emerging trends in artificial intelligence–driven digital health technologies and their influence on nursing practice across the 5 domains outlined by the Canadian Nurses Association framework: administration, clinical care, education, policy, and research. Specifically, this scoping review will examine how emerging trends will transform the roles and functions of nurses over the next 10 years and beyond. Methods: Using an established scoping review methodology, MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Embase, PsycINFO, Cochrane Database of Systematic Reviews, Cochrane Central, Education Resources Information Centre, Scopus, Web of Science, and Proquest databases were searched. In addition to the electronic database searches, a targeted website search will be performed to access relevant grey literature. Abstracts and full-text studies will be independently screened by 2 reviewers using prespecified inclusion and exclusion criteria. Included literature will focus on nursing and digital health technologies that incorporate artificial intelligence. Data will be charted using a structured form and narratively summarized. Results: Electronic database searches have retrieved 10,318 results. The scoping review and subsequent briefing paper will be completed by the fall of 2020. Conclusions: A symposium will be held to share insights gained from this scoping review with key thought leaders and a cross section of stakeholders from administration, clinical care, education, policy, and research as well as patient advocates. The symposium will provide a forum to explore opportunities for action to advance the future of nursing in a technological world and, more specifically, nurses’ delivery of compassionate care in the age of artificial intelligence. Results from the symposium will be summarized in the form of a briefing paper and widely disseminated to relevant stakeholders.

Introduction Exercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults. Methods and analysis A two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website.

Background: Coronavirus disease (COVID-19) has spread globally with far-reaching, significant, and unprecedented impacts on health and everyday life. Threats to mental health, psychological safety, and well-being are now emerging, increasing the impact of this virus on world health. Providing support for these challenges is difficult because of the high number of people requiring support in the context of a need to maintain physical distancing. This protocol describes the use of SMS text messaging (Text4Hope) as a convenient, cost-effective, and accessible population-level mental health intervention. This program is evidence-based, with prior research supporting good outcomes and high user satisfaction. Objective: The project goal is to implement a program of daily supportive SMS text messaging (Text4Hope) to reduce distress related to the COVID-19 crisis, initially among Canadians. The prevalence of stress, anxiety, and depressive symptoms; the demographic correlates of the same; and the outcomes of the Text4Hope intervention in mitigating distress will be evaluated. Methods: Self-administered anonymous online questionnaires will be used to assess stress (Perceived Stress Scale), anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]), and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]). Data will be collected at baseline (onset of SMS text messaging), the program midpoint (6 weeks), and the program endpoint (12 weeks). Results: Data analysis will include parametric and nonparametric techniques, focusing on primary outcomes (ie, stress, anxiety, and depressive symptoms) and metrics of use, including the number of subscribers and user satisfaction. Given the large size of the data set, machine learning and data mining methods will also be used. Conclusions: This COVID-19 project will provide key information regarding prevalence rates of stress, anxiety, and depressive symptoms during the pandemic; demographic correlates of distress; and outcome data related to this scalable population-level intervention. Information from this study will be valuable for practitioners and useful for informing policy and decision making regarding psychological interventions during the pandemic.

Introduction An online interactive repository of available medication adherence technologies may facilitate their selection and adoption by different stakeholders. Developing a repository is among the main objectives of the European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE) COST Action (CA19132). However, meeting the needs of diverse stakeholders requires careful consideration of the repository structure. Methods and analysis A real-time online Delphi study by stakeholders from 39 countries with research, practice, policy, patient representation and technology development backgrounds will be conducted. Eleven ENABLE members from 9 European countries formed an interdisciplinary steering committee to develop the repository structure, prepare study protocol and perform it. Definitions of medication adherence technologies and their attributes were developed iteratively through literature review, discussions within the steering committee and ENABLE Action members, following ontology development recommendations. Three domains ( product and provider information (D1), medication adherence descriptors (D2) and evaluation and implementation (D3 )) branching in 13 attribute groups are proposed: product and provider information, target use scenarios, target health conditions, medication regimen, medication adherence management components, monitoring/measurement methods and targets, intervention modes of delivery, target behaviour determinants, behaviour change techniques, intervention providers, intervention settings, quality indicators and implementation indicators . Stakeholders will evaluate the proposed definition and attributes’ relevance, clarity and completeness and have multiple opportunities to reconsider their evaluations based on aggregated feedback in real-time. Data collection will stop when the predetermined response rate will be achieved. We will quantify agreement and perform analyses of process indicators on the whole sample and per stakeholder group. Ethics and dissemination Ethical approval for the COST ENABLE activities was granted by the Malaga Regional Research Ethics Committee. The Delphi protocol was considered compliant regarding data protection and security by the Data Protection Officer from University of Basel. Findings from the Delphi study will form the basis for the ENABLE repository structure and related activities.

Background: Symptom checker apps (SCAs) are accessible tools that provide early symptom assessment for users. The ethical, legal, and social implications of SCAs and their impact on the patient-physician relationship, the health care providers, and the health care system have sparsely been examined. This study protocol describes an approach to investigate the possible impacts and implications of SCAs on different levels of health care provision. It considers the perspectives of the users, nonusers, general practitioners (GPs), and health care experts. Objective: We aim to assess a comprehensive overview of the use of SCAs and address problematic issues, if any. The primary outcomes of this study are empirically informed multi-perspective recommendations for different stakeholders on the ethical, legal, and social implications of SCAs. Methods: Quantitative and qualitative methods will be used in several overlapping and interconnected study phases. In study phase 1, a comprehensive literature review will be conducted to assess the ethical, legal, social, and systemic impacts of SCAs. Study phase 2 comprises a survey that will be analyzed with a logistic regression. It aims to assess the user degree of SCAs in Germany as well as the predictors for SCA usage. Study phase 3 will investigate self-observational diaries and user interviews, which will be analyzed as integrated cases to assess user perspectives, usage pattern, and arising problems. Study phase 4 will comprise GP interviews to assess their experiences, perspectives, self-image, and concepts and will be analyzed with the basic procedure by Kruse. Moreover, interviews with health care experts will be conducted in study phase 3 and will be analyzed by using the reflexive thematical analysis approach of Braun and Clark. Results: Study phase 1 will be completed in November 2021. We expect the results of study phase 2 in December 2021 and February 2022. In study phase 3, interviews are currently being conducted. The final study endpoint will be in February 2023. Conclusions: The possible ethical, legal, social, and systemic impacts of a widespread use of SCAs that affect stakeholders and stakeholder groups on different levels of health care will be identified. The proposed methodological approach provides a multifaceted and diverse empirical basis for a broad discussion on these implications. Trial Registration: German Clinical Trials Register (DRKS) DRKS00022465; https://tinyurl.com/yx53er67

Background: Chronic pain is a highly prevalent condition that requires multidisciplinary treatment. However, in the United Kingdom, access to specialist pain clinics where patients can receive medical multidisciplinary treatment is limited, and provision varies between health boards. As such, self-management of chronic pain using digital tools has been gaining traction recently, but evidence of its effectiveness from clinical-based trials focuses mainly on quantitative outcomes. Objective: This systematic review aims to identify, appraise, and synthesize qualitative evidence on patients’ experiences with digital health interventions (DHIs) for the management of chronic pain. Methods: This systematic review will consider qualitative and mixed methods studies that explore the experience of patients (aged 18 years and older) with chronic pain engaging in DHIs to manage their pain. MEDLINE Ovid, PubMed, Embase, CINAHL, PsycINFO, and Scopus databases will be searched for published studies. The systematic review will be conducted in accordance with the ENTREQ (Enhancing Transparency in Reporting the Synthesis of Qualitative Research) guidelines. Following the 3-step thematic synthesis methodology of Thomas and Harden, titles and abstracts will be screened by 2 independent reviewers (AM and HM), and a third reviewer (MI or FM) will resolve any conflict that arises before the full-text screening. The Critical Appraisal Skills Programme checklist tool will be used to critically appraise the included studies. The extracted data will be imported to NVivo (QSR International), where thematic synthesis will be used to derive analytical themes from the included studies. Results: Themes that encapsulate the patient experience will be identified from qualitative evidence, and these themes will shed light on the perceived benefits and disadvantages, usability, acceptability, and the overall impact digital tools can have on the lives of those with chronic pain. Conclusions: This systematic review will identify, appraise, and synthesize the overall experience of patients engaging in DHI to manage a diverse range of chronic pain conditions. By elaborating the patient experience through qualitative analysis, the findings from this review will enhance our current understanding of the experiences of patients with chronic pain using digital tools for the self-management of their pain and highlight what person-centered elements are essential for future DHI development. Trial Registration: PROSPERO CRD42023445100; http://tinyurl.com/4z77khfs International Registered Report Identifier (IRRID): DERR1-10.2196/52469

Background: The process of designing a digital health intervention (DHI)—also referred to as mobile health or eHealth—spans needs assessments, technical functionality and feasibility, user satisfaction, effectiveness, impact, and value. These interventions are causing a rapid evolution in the landscape of health care. Multiple studies have shown their propensity to extend both the quality and reach of interventions. However, failure to improve DHI design is linked to failed uptake and health outcomes. This dilemma is further conflicted by the colliding backdrops of the digital and health industries, both of which approach, understand, and involve end users differently in the framing of a DHI. Objective: The objective of this systematic review is to assess the challenges to incorporating end users in the design stage of digital health interventions, to identify key pain points, and to identify limitations and gaps for areas of future investigation. Methods: The PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols) checklist will be used to structure this protocol. A systematic search of the PsycINFO, PubMed (MEDLINE), Web of Science, CINAHL, Scopus, and IEEE Xplore databases will be conducted. Additionally, the PerSPEcTiF guidelines for complex interventions will be consulted. Two reviewers 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 February 2021, we have completed a preliminary literature search examining challenges to the incorporation of end users in the design stage of DHIs. Systematic searches, data extraction and analysis, and writing of the systematic review are expected to be completed by December 2021. Conclusions: This systematic review aims to provide an effective summary of key pain points toward incorporating end users in DHIs. Results from this review will provide an evidence base for a better approach to end user involvement in the interest of improving efficacy and uptake of DHIs.

Background Cardiac rehabilitation programs aim to avoid further progression and relapse of cardiovascular diseases (CVDs). Patients with CVDs undergoing rehabilitation often experience difficulties in integrating and transferring the learned health behaviors into their daily life after returning home. This includes regular physical activity (PA) and sufficient fruit and vegetable consumption (FVC). eHealth individualized interventions have shown to be effective in increasing PA and FVC in home settings. As WeChat is the most popular social media site in China, this should be used for the intervention. The aim of this study is to develop and examine a WeChat mini program-based intervention on PA and FVC promotion among Chinese cardiovascular patients in home-based rehabilitation. Methods The study will adopt a randomized controlled trial (RCT), comprising a WeChat mini program-based intervention group and a waiting-list control group. The intervention content will be designed based on the Health Action Process Approach (HAPA). One hundred fifty-eight outpatients will be recruited from the cardiac rehabilitation center of a hospital in southern China and randomly assigned to one of the two groups. During the 10-week duration of the intervention, participants will be invited to access a WeChat mini program comprising two Modules. Module 1 provides weekly learning sessions addressing PA and FVC simultaneously for 10 weeks. Module 2 provides a platform, where participants can review their progress with Module 1 at any time and attend incentive activities aiming at promoting engagement and retention. The outcome variables include PA (mins/week), FVC (portion/day), healthy lifestyle (the synthesis of PA and FVC), social-cognitive predictors of behavior change (risk perception, outcome expectancies, self-efficacy, intention, planning, social support, and action control) as well as health outcomes (Body mass index, depression, and quality of life). Data collection will be implemented at pre-test, post-test and a post-test after 3-month respectively. Discussion The current study will be significant to understand how such a cost-effective social media mini program-based intervention enables participants to adopt and maintain a healthy lifestyle. If it is effective, it will enrich home-based cardiac rehabilitation approaches which can in turn save the lives of patients as well as much monetary, time and other investments. Trial Registration The study was registered at ClinicalTrials.gov (Identifier: NCT03636724; Last update posted: July 28, 2020).

Introduction Increasing demand for healthcare services worldwide has led to unprecedented challenges in managing patient flow and delivering timely care in emergency care settings. Overcrowding, prolonged waiting times, reduced patient satisfaction and increased mortality are some of the consequences of this increased demand.

Background: An estimated 40% of people living with HIV smoke cigarettes. Although smoking rates in the United States have been declining in recent years, people living with HIV continue to smoke cigarettes at twice the rate of the general population. Mobile health (mHealth) technology is an effective tool for people living with a chronic illness, such as HIV, as currently 84% of households in the United States report that they have a smartphone. Although many studies have used mHealth interventions for smoking cessation, few studies have recruited people living with HIV who smoke. Objective: The objective of the pilot randomized controlled trial (RCT) is to examine the feasibility, acceptability, and preliminary efficacy of the Sense2Quit App as a tool for people living with HIV who are motivated to quit smoking. Methods: The Sense2Quit study is a 2-arm RCT for people living with HIV who smoke cigarettes (n=60). Participants are randomized to either the active intervention condition, which consists of an 8-week supply of nicotine replacement therapy, standard smoking cessation counseling, and access to the Sense2Quit mobile app and smartwatch, or the control condition, which consists of standard smoking cessation counseling and a referral to the New York State Smokers’ Quitline. The Sense2Quit app is a mobile app connected through Bluetooth to a smartwatch that tracks smoking gestures and distinguishes them from other everyday hand movements. In the Sense2Quit app, participants can view their smoking trends, which are recorded through their use of the smartwatch, including how often or how much they smoke and the amount of money that they are spending on cigarettes, watch videos with quitting tips, information, and distractions, play games, set reminders, and communicate with a study team member. Results: Enrollment of study participants began in March 2023 and is expected to end in October 2023. All data collection is expected to be completed by the end of January 2024. This RCT will test the difference in outcomes between the control and intervention arms. The primary outcome will be the percentage of participants with biochemically verified 7-day point prevalence smoking or tobacco abstinence at their 12-week follow-up. Results from this pilot study will be disseminated to the research community following the completion of all data collection. Conclusions: The Sense2Quit study leverages mHealth so that it can help smokers improve their efforts at smoking cessation. Our research has the potential to not only increase quitting rates among people living with HIV who may need a prolonged, tailored intervention but also inform further development of mHealth for people living with HIV. This mHealth study will contribute significant findings to the greater mHealth research community, providing evidence as to how mHealth should be developed and tested among the target population.

Background: Black cisgender gay, bisexual, and other sexual minority men (SMM) and transgender women (TW) continue to be heavily affected by HIV. Further research is needed to better understand HIV prevention and care outcomes in this population. In particular, there is a need for research examining the impact of substance use and sleep health on HIV prevention and treatment outcomes among Black SMM and TW. Objective: This paper outlines the study methods being used in the recently launched follow-up study to the Neighborhoods and Networks (N2) study, which we refer to as N2 Part 2 (N2P2). N2P2 aims to address this gap in the literature, build off the findings of the original N2 study, and identify socioenvironmental determinants of health, including whether neighborhood and network factors mediate and moderate these relationships. Methods: Building on the N2 cohort study in Chicago from 2018 to 2022, N2P2 used a prospective longitudinal cohort design and an observational-implementation hybrid approach. With sustained high levels of community engagement, we aim to recruit a new sample of 600 Black SMM and TW participants residing in the Chicago metropolitan statistical area. Participants are asked to participate in 3 study visits across an 18-month study period (1 visit every 9 months). Four different forms of data are collected per wave: (1) an in-person survey, (2) biological specimen collection, (3) a daily remote ecological momentary assessment for 14 days after each study visit, and (4) data from electronic health records. These forms of data collection continue to assess neighborhood and network factors and specifically explore substance use, sleep, immune function, obesity, and the implementation of potential interventions that address relevant constructs (eg, alcohol use and pre-exposure prophylaxis adherence). Results: The N2P2 study was funded in August 2021 by the National Institute of Drug Abuse (R01DA054553 and R21DA053156) and National Heart, Lung, and Blood Institute (R01HL160325). This study was launched in November 2022. Recruitment and enrollment for the first wave of data collection are currently ongoing. Conclusions: The N2P2 study is applying innovative methods to comprehensively explore the impacts of substance use and sleep health on HIV-related outcomes among an HIV status–neutral cohort of Black SMM and TW in Chicago. This study is applying an observational-implementation hybrid design to help us achieve findings that support rapid translation, a critical priority among populations such as Black SMM and TW that experience long-standing inequities with regard to HIV and other health-related outcomes. N2P2 will directly build off the findings that have resulted from the original N2 study among Black SMM and TW in Chicago. These findings provide a better understanding of multilevel (eg, individual, network, and neighborhood) factors that contribute to HIV-related outcomes and viral suppression among Black SMM and TW.

Background: The synthesis of evidence in health care is essential for informed decision-making and policy development. This study aims to validate The Umbrella Collaboration (TU), an innovative, semiautomatic tertiary evidence synthesis methodology, by comparing it with Traditional Umbrella Reviews (TUR), which are currently the gold standard. Objective: This study aimed to evaluate whether TU, an artificial intelligence—assisted, software-driven system for tertiary evidence synthesis, can achieve comparable effectiveness to TURs, while offering a more timely, efficient, and comprehensive approach. In addition, as a secondary objective, the study aims to assess the accessibility and comprehensibility of TU’s outputs to ensure its usability and practical applicability for health care professionals. Methods: This protocol outlines a comparative study divided into 2 main parts. The first part involves a quantitative comparison of results obtained using TU and TURs in geriatrics. We will evaluate the identification, size effect, direction, statistical significance, and certainty of outcomes, as well as the time and resources required for each methodology. Data for TURs will be sourced from Medline (via PubMed), while TU will use artificial intelligence—assisted informatics to replicate the research questions of the selected TURs. The second part of the study assesses the ease of use and comprehension of TU through an online survey directed at health professionals, using interactive features and detailed data access. Results: Expected results include the assessment of concordance in identifying outcomes, the size effect, direction and significance of these outcomes, and the certainty of evidence. In addition, we will measure the operational efficiency of each methodology by evaluating the time taken to complete projects. User perceptions of the ease of use and comprehension of TU will be gathered through detailed surveys. The implementation of new methodologies in evidence synthesis requires validation. This study will determine whether TU can match the accuracy and comprehensiveness of TURs while offering benefits in terms of efficiency and user accessibility. The comparative study is designed to address the inherent challenges in validating a new methodology against established standards. Conclusions: If TU proves as effective as TURs but more time-efficient, accessible, and easily updatable, it could significantly enhance the process of evidence synthesis, facilitating informed decision-making and improving health care. This study represents a step toward integrating innovative technologies into routine evidence synthesis practice, potentially transforming health research.

Background: When introducing artificial intelligence (AI) into clinical care, one of the main objectives is to improve workflow efficiency because AI-based solutions are expected to take over or support routine tasks. Objective: This study sought to synthesize the current knowledge base on how the use of AI technologies for medical imaging affects efficiency and what facilitators or barriers moderating the impact of AI implementation have been reported. Methods: In this systematic literature review, comprehensive literature searches will be performed in relevant electronic databases, including PubMed/MEDLINE, Embase, PsycINFO, Web of Science, IEEE Xplore, and CENTRAL. Studies in English and German published from 2000 onwards will be included. The following inclusion criteria will be applied: empirical studies targeting the workflow integration or adoption of AI-based software in medical imaging used for diagnostic purposes in a health care setting. The efficiency outcomes of interest include workflow adaptation, time to complete tasks, and workload. Two reviewers will independently screen all retrieved records, full-text articles, and extract data. The study’s methodological quality will be appraised using suitable tools. The findings will be described qualitatively, and a meta-analysis will be performed, if possible. Furthermore, a narrative synthesis approach that focuses on work system factors affecting the integration of AI technologies reported in eligible studies will be adopted. Results: This review is anticipated to begin in September 2022 and will be completed in April 2023. Conclusions: This systematic review and synthesis aims to summarize the existing knowledge on efficiency improvements in medical imaging through the integration of AI into clinical workflows. Moreover, it will extract the facilitators and barriers of the AI implementation process in clinical care settings. Therefore, our findings have implications for future clinical implementation processes of AI-based solutions, with a particular focus on diagnostic procedures. This review is additionally expected to identify research gaps regarding the focus on seamless workflow integration of novel technologies in clinical settings. Trial Registration: PROSPERO CRD42022303439; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=303439

Background: The French organized population-based cervical cancer screening (CCS) program transitioned from a cytology-based to a human papillomavirus (HPV)–based screening strategy in August 2020. HPV testing is offered every 5 years, starting at the age of 30 years. In the new program, women are invited to undergo an HPV test at a gynecologist’s, primary care physician’s, or midwife’s office, a private clinic or health center, family planning center, or hospital. HPV self-sampling (HPVss) was also made available as an additional approach. However, French studies reported that less than 20% of noncompliant women performed vaginal self-sampling when a kit was sent to their home. Women with lower income and educational levels participate less in CCS. Lack of information about the disease and the benefits of CCS were reported as one of the major barriers among noncompliant women. This barrier could be addressed by overcoming disparities in HPV- and cervical cancer–related knowledge and perceptions about CCS. Objective: This study aimed to assess the effectiveness of a chatbot-based decision aid to improve women’s participation in the HPVss detection-based CCS care pathway. Methods: AppDate-You is a 2-arm cluster randomized controlled trial (cRCT) nested within the French organized CCS program. Eligible women are those aged 30-65 years who have not been screened for CC for more than 4 years and live in the disadvantaged clusters in the Occitanie Region, France. In total, 32 clusters will be allocated to the intervention and control arms, 16 in each arm (approximately 4000 women). Eligible women living in randomly selected disadvantaged clusters will be identified using the Regional Cancer Screening Coordinating Centre of Occitanie (CRCDC-OC) database. Women in the experimental group will receive screening reminder letters and HPVss kits, combined with access to a chatbot-based decision aid tailored to women with lower education attainment. Women in the control group will receive the reminder letters and HPVss kits (standard of care). The CRCDC-OC database will be used to check trial progress and assess the intervention’s impact. The trial has 2 primary outcomes: (1) the proportion of screening participation within 12 months among women recalled for CCS and (2) the proportion of HPVss-positive women who are “well-managed” as stipulated in the French guidelines. Results: To date, the AppDate-You study group is preparing and developing the chatbot-based decision aid (intervention). The cRCT will be conducted once the decision aid has been completed and validated. Recruitment of women is expected to begin in January 2023. Conclusions: This study is the first to evaluate the impact of a chatbot-based decision aid to promote the CCS program and increase its performance. The study results will inform policy makers and health professionals as well as the research community. Trial Registration: ClinicalTrials.gov NCT05286034; https://clinicaltrials.gov/ct2/show/NCT05286034

Background: Preschoolers’ lifestyles have become physically inactive and sedentary, their eating habits have become unhealthy, and their sleep routines have become increasingly disturbed. Parent-based interventions have shown promise to improve physical activity (PA), improve dietary behavior (DB), and reduce sleep problems among preschoolers. However, because of the recognized obstacles of face-to-face approaches (eg, travel costs and time commitment), easy access and lower costs make eHealth interventions appealing. Previous studies that examined the effectiveness of parent-based eHealth for preschoolers’ PA, DB, and sleep have either emphasized 1 variable or failed to balance PA, DB, and sleep modules and consider the intervention sequence during the intervention period. There is an acknowledged gap in parent-based eHealth interventions that target preschoolers raised in Chinese cultural contexts. Objective: This study aims to investigate the effectiveness of a parent-based eHealth intervention for PA, DB, and sleep problems among Chinese preschoolers. Methods: This 2-arm, parallel, randomized controlled trial comprises a 12-week intervention with a 12-week follow-up. A total of 206 parent-child dyads will be randomized to either an eHealth intervention group or a control group. Participants allocated to the eHealth intervention group will receive 12 interactive modules on PA, DB, and sleep, with each module delivered on a weekly basis to reduce the sequence effect on variable outcomes. The intervention is grounded in social cognitive theory. It will be delivered through social media, where parents can obtain valid and updated educational information, have a social rapport, and interact with other group members and facilitators. Participants in the control group will receive weekly brochures on PA, DB, and sleep recommendations from kindergarten teachers, but they will not receive any interactive components. Data will be collected at baseline, 3 months, and 6 months. The primary outcome will be preschoolers’ PA. The secondary outcomes will be preschoolers’ DB, preschoolers’ sleep duration, preschoolers’ sleep problems, parents’ PA, parenting style, and parental feeding style. Results: Parent-child dyads were recruited in September 2023. Baseline and posttest data collection occurred from October 2023 to March 2024. The follow-up data will be obtained in June 2024. The results of the study are expected to be published in 2025. Conclusions: The parent-based eHealth intervention has the potential to overcome the barriers of face-to-face interventions and will offer a novel approach for promoting a healthy lifestyle among preschoolers. If this intervention is found to be efficacious,

Introduction Peer online mental health forums are commonly used and offer accessible support. Positive and negative impacts have been reported by forum members and moderators, but it is unclear why these impacts occur, for whom and in which forums. This multiple method realist study explores underlying mechanisms to understand how forums work for different people. The findings will inform codesign of best practice guidance and policy tools to enhance the uptake and effectiveness of peer online mental health forums. Methods and analysis In workstream 1, we will conduct a realist synthesis, based on existing literature and interviews with approximately 20 stakeholders, to generate initial programme theories about the impacts of forums on members and moderators and mechanisms driving these. Initial theories that are relevant for forum design and implementation will be prioritised for testing in workstream 2. Workstream 2 is a multiple case study design with mixed methods with several online mental health forums differing in contextual features. Quantitative surveys of forum members, qualitative interviews and Corpus-based Discourse Analysis and Natural Language Processing of forum posts will be used to test and refine programme theories. Final programme theories will be developed through novel triangulation of the data. Workstream 3 will run alongside workstreams 1 and 2. Key stakeholders from participating forums, including members and moderators, will be recruited to a Codesign group. They will inform the study design and materials, refine and prioritise theories, and codesign best policy and practice guidance. Ethics and dissemination Ethical approval was granted by Solihull Research Ethics Committee (IRAS 314029). Findings will be reported in accordance with RAMESES (Realist And MEta-narrative Evidence Syntheses: Evolving Standards) guidelines, published as open access and shared widely, along with codesigned tools. Trial registration number ISRCTN 62469166; the protocol for the realist synthesis in workstream one is prospectively registered at PROSPERO CRD42022352528.

Objective: This study describes a research protocol for a behavioral marker-based predictive model that examines the functional status of older adults with subjective cognitive decline and mild cognitive impairment. Methods: A total of 130 older adults aged ≥65 years with subjective cognitive decline or mild cognitive impairment will be recruited from the Dementia Relief Centers or the Community Service Centers. Data on behavioral and psychosocial markers (e.g. physical activity, mobility, sleep/wake patterns, social interaction, and mild behavioral impairment) will be collected using passive wearable actigraphy, in-person questionnaires, and smartphone-based ecological momentary assessments. Two follow-up assessments will be performed at 12 and 24 months after baseline. Mixed-effect machine learning models: MErf, MEgbm, MEmod, and MEctree, and standard machine learning models without random effects [random forest, gradient boosting machine] will be employed in our analyses to predict functional status over time. Results: The results of this study will be fundamental for developing tailored digital interventions that apply deep learning techniques to behavioral data to predict, identify, and aid in the management of functional decline in older adults with subjective cognitive decline and mild cognitive impairment. These older adults are considered the optimal target population for preventive interventions and will benefit from such tailored strategies. Conclusions: Our study will contribute to the development of self-care interventions that utilize behavioral data and machine learning techniques to provide automated analyses of the functional decline of older adults who are at risk for dementia.

Introduction Living in an area with no or deficient structures for trans health care is disadvantageous for trans people. By providing an internet-based health care programme, i²TransHealth aims at reducing structural disadvantages for trans people living in areas lacking specialised care. The e-health intervention consists of video consultations and a 1:1 chat with a study therapist. Additionally, the i²TransHealth network cooperates with physicians, who especially offer crisis intervention close to the participants’ place of residence. The aim of this study is to evaluate the (cost-)effectiveness of the internet-based health care programme for trans people compared with a control (waiting) group. The following research questions will be examined with a sample of 163 trans people: Does a 4-month treatment with the i²TransHealth internet-based health care programme improve patient-reported health-outcomes? Is i²TransHealth cost-effective compared with standard care from a societal or health care payers’ perspective? Does the participation in and support by i²TransHealth lead to an increase of trans-related expertise in the physician network? Methods and analysis In a randomised controlled trial, the outcomes of an internet-based health care programme for trans people will be investigated. In the intervention group, participants are invited to use i²TransHealth for 4 months. Participants allocated to the control group will be able to start with their transition-related care after 4 months of study participation. The primary outcome measure is defined as the reduction of psychosomatic symptoms, as assessed by the Brief Symptom Inventory-18, 4 months after using the i²TransHealth programme. Participants in both groups will undergo an assessment at baseline and 4 months after using i²TransHealth. Ethics and dissemination Positive ethical approval was obtained from the Hamburg Medical Association (PV7131). The results will be disseminated to service users and their families via media, to health care professionals via professional training and meetings and to researchers via conferences and publications. Trial registration number NCT04290286 . Protocol version 22 December 2021 (V.1.0)

Background Chronic obstructive pulmonary disease (COPD) is a highly prevalent respiratory disease associated with significant health decline and economic burdens. Pulmonary rehabilitation is an effective intervention, but securing adherence to exercise is difficult, particularly for frail and disabled patients, challenged by leaving their home. Home-based exercise is an emerging alternative for persons with COPD, but long-term adherence is unclear. This study aims to investigate the effects, experiences and acceptability of long-term home-based cycling for patients with COPD post exacerbation.

Background: Mood and anxiety disorders are prevalent mental health diagnoses. Numerous studies have shown that measurement-based care, which is used to monitor patient symptoms, functioning, and treatment progress and help guide clinical decisions and collaboration on treatment goals, can improve outcomes in patients with these disorders. Including digital information regarding patients’ electronic communications and social media activity is an innovative approach to augmenting measurement-based care. Recent data indicate interest and willingness from both mental health clinicians and patients to share this type of digital information in treatment sessions. However, the clinical benefit of systematically doing this has been minimally evaluated. Objective: This study aims to develop an electronic dashboard for tracking patients’ digital social activity and a protocol for a pragmatic randomized trial to test the feasibility and efficacy of using the dashboard in real-world clinical care of patients with depression or anxiety disorders. Methods: We developed a personalized electronic dashboard that tracks patients’ electronic communications and social media activity, visualizes data on these interactions through key graphics and figures, and provides a tool that can be readily integrated into routine clinical care for use by clinicians and patients during treatment sessions. We then designed a randomized trial to evaluate the feasibility and effectiveness of using the electronic dashboard in real-world care compared to treatment as usual. The trial included patients aged ≥12 years with a mood or anxiety disorder who were receiving treatment in outpatient psychiatry clinics in the Johns Hopkins Health System and the Kennedy Krieger Institute. The primary outcome includes changes in patient-rated depression symptoms. Secondary outcomes include changes in patient-rated anxiety symptoms and overall functioning. Exploratory analyses examine the impact of the intervention on measures of therapeutic alliance and the detection of clinically actionable targets. Results: We successfully developed an electronic dashboard for tracking patients’ electronic communications and social media activity, and we implemented a protocol for evaluating the feasibility and efficacy of using the dashboard in routine care for mood or anxiety disorders. The protocol was approved by the Johns Hopkins University School of Medicine Institutional Review Board. In this study, we report the technological, ethical, and pragmatic considerations in developing the dashboard and testing it in a real-world setting. Conclusions: The integration of an electronic dashboard to monitor digital social activity in mental health care treatment is novel. This study examines the feasibility and effectiveness of the dashboard and the challenges in implementing this protocol. The lessons learned from developing and implementing the study will inform ongoing discussions about the value of gathering collateral information on patients’ digital social activity and how to do so in a way that is acceptable and clinically effective. Clinical Trial: ClinicalTrials.gov NCT03925038; https://clinicaltrials.gov/study/NCT03925038

Background: There is great potential for delivering cost-effective, quality health care for patients with chronic conditions through digital interventions. Managing chronic conditions often includes a substantial workload required for adhering to the treatment regimen and negative consequences on the patient’s function and well-being. This treatment burden affects adherence to treatment and disease outcomes. Digital interventions can potentially exacerbate the burden but also alleviate it. Objective: The objective of this review is to identify, summarize, and synthesize the evidence of how digital interventions impact the treatment burden of people with chronic conditions. Methods: The search, selection, and data synthesis processes were designed according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015. A systematic search was conducted on October 16, 2023, from databases PubMed, Scopus, Web of Science, ACM, PubMed Central, and CINAHL. Results: Preliminary searches have been conducted, and screening has been started. The review is expected to be completed in October 2024. Conclusions: As the number of patients with chronic conditions is increasing, it is essential to design new digital interventions for managing chronic conditions in a way that supports patients with their treatment burden. To the best of our knowledge, the proposed systematic review will be the first review that investigates the impact of digital interventions on the treatment burden of patients. The results of this review will contribute to the field of health informatics regarding knowledge of the treatment burden associated with digital interventions and practical implications for developing better digital health care for patients with chronic conditions.

Introduction Breast cancer is the most prevalent cancer among women. The treatment is extensive; in addition to surgery, various combinations of radiation therapy, chemotherapy and antibody and endocrine treatment can be applied. Cancer-related fatigue (CRF) is high in patients with breast cancer, peaking during chemotherapy, but may persist for several years. Physical activity has proven to be effective in reducing CRF in breast cancer rehabilitation, but many patients tend to be less active after the diagnosis. Yoga has a previously demonstrated effect on energy levels and digitally distributed yoga intervention can potentially increase accessibility in pandemic times and facilitate participation for patients susceptible to infection and those living far from organised rehabilitation opportunities. The purpose of this study, Digital Yoga Intervention in Cancer Rehabilitation (DigiYoga CaRe) is to investigate whether a 12-week digitally distributed yoga intervention can reduce CRF and stress, improve health-related quality of life (HRQL) and affect pro-inflammatory and metabolic markers in patients with breast cancer. Methods and analysis This multicentre study will adopt a randomised controlled design including 240 persons after their breast cancer surgery. They will be randomised to a 12-week digitally distributed yoga intervention or to a control group. The intervention group practice yoga two times a week, one yoga class live-streamed to the patient’s computer or mobile device and one prerecorded video class for self-training. The controls receive standardised care, gift cards for flowers and access to yoga video links after the data collection has ended. The primary analysis will be performed following the principle of intention to treat. Data will be collected by questionnaires, blood samples, accelerometers and interviews. Ethics and dissemination The DigiYoga CaRe study was approved by the Regional Ethical Review Board in Lund. The final results of this study will be disseminated to conference, patient and public involvements and peerreviewed publications. Trial registration number NCT04812652.

Mobile monitoring of outpatients during cancer therapy becomes possible through technological advancements. This study leveraged a new remote patient monitoring app for in-between systemic therapy sessions. Patients' evaluation showed that the handling is feasible. Clinical implementation must consider an adaptive development cycle for reliable operations.

Background: There is sound evidence associating high salt intake and a greater risk of cardiovascular and noncardiovascular diseases. High salt intake has been observed in several populations worldwide. Therefore, promoting healthier salt consumption has been encouraged as a low-cost strategy to reduce this risk factor. However, these strategies need to be sound, built on theoretical and methodological bases, and consider the target population’s context. Objective: This protocol aims to describe a mobile phone app intervention to promote healthy salt intake among adults. Methods: This is an experimental and longitudinal study protocol conducted in three modules. Module 1 refers to the planning of the intervention based on the Behaviour Change Wheel framework. Module 2 is the development of the mobile phone app intervention based on the date of module 1. In module 3, the intervention will be evaluated using a randomized controlled study, with three steps of data collection in a 2-month follow-up in a sample of 86 adults (43 participants for each group: the control group and intervention group) recruited from the primary health care centers of a Brazilian town. The discretionary salt intake questionnaire will assess salt consumption, the app usability will be assessed using the System Usability Scale, and psychosocial variables (habit, intention, and self-efficacy) will also be measured. Results: Recruitment began in October 2021, and the follow-up will end in August 2022. The results of this study are expected to be published in 2023. Conclusions: Results from this study will help people to control salt intake when cooking at home, will stimulate self-care, will work as an alternative or supportive method in the relationship between health care professionals and patients, and will contribute to implementing the app intervention to promote healthy salt intake on a large scale. Trial Registration: The Brazilian Clinical Trials Registry RBR-4s8qyyq; https://ensaiosclinicos.gov.br/rg/RBR-4s8qyyq

Background: Physical activity is a critical component of both well-being and preventative health, reducing the risk of both chronic mental and physical conditions and early death. Yet, there are numerous groups in society who are not able to undertake as much physical activity as they would like to. This includes informal (unpaid) carers, with the United Kingdom national survey data suggesting that 81% would like to do more physical activity on a regular basis. There is a clear need to develop innovations, including digital interventions that hold implementation potential to support regular physical activity in groups such as carers. Objective: This study aims to expand and personalize a cross-platform digital health app designed to support regular physical activity in carers of people with dementia for a period of 8 weeks and evaluate the potential for implementation. Methods: The CareFit for dementia carers study was a mixed methods co-design, development, and evaluation of a novel motivational smartphone app to support home-based regular physical activity for unpaid dementia carers. The study was planned to take place across 16 months in total (September 1, 2022, to December 31, 2023). The first phase included iterative design sprints to redesign an initial prototype for widespread use, supported through a bespoke content management system. The second phase included the release of the “CareFit” app across Scotland through invitations on the Apple and Google stores where we aimed to recruit 50 carers and up to 20 professionals to support the delivery in total. Partnerships for the work included a range of stakeholders across charities, health and social care partnerships, physical activity groups, and carers’ organizations. We explored the implementation of CareFit, guided by both Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and the Complex Intervention Frameworks. Results: Project processes and outcomes were evaluated using mixed methods. The barriers and enablers for professional staff to signpost and use CareFit with clients were assessed through interviews or focus groups and round stakeholder meetings. The usability of CareFit was explored through qualitative interviews with carers and a system usability scale. We examined how CareFit could add value to carers by examining “in-app” data, pre-post questionnaire responses, and qualitative work, including interviews and focus groups. We also explored how CareFit could add value to the landscape of other online resources for dementia carers. Conclusions: Results from this study will contribute new knowledge including identifying (1) suitable pathways to identify and support carers through digital innovations; (2) future design of definitive studies in carer populations; and (3) an improved understanding of the Reach, Effectiveness, Adoption, Implementation, and Maintenance across a range of key stakeholders.

Background: The number of elective outpatient surgeries in Canada has increased markedly in the last 10 years. However, unanticipated cancellations on the day of surgery and adverse postoperative events are frequent. Modern technologies have been shown to be of great help in the medical field in improving patient care. Thus, it is likely that dedicated technologies could also significantly improve surgical outpatients’ pathways. Therefore, the department of anesthesiology at the University of Montreal Medical Center, in collaboration with LeoMed, a telemedicine platform, has developed a telehealth solution to offer more efficient perioperative support and follow-up for patients undergoing ambulatory surgery. Objective: The objective is to evaluate the medicoeconomic benefit of a dedicated perioperative telehealth platform for patients undergoing day surgery. Our hypothesis is that this dedicated telecare solution will allow more efficient patient care, which will reduce all types of medical costs related to day surgery pathways. Methods: This study is a single-center, single-blinded, 2-group randomized controlled trial. One thousand patients aged over 18 years with internet access who are scheduled to undergo ambulatory surgery will be enrolled and randomized either to follow a perioperative path that includes a patient-tailored perioperative digital app via the LeoMed telecare platform for 1 month or to follow the standard of care, which does not offer personalized digital support. The primary outcome will be to evaluate the cost-effectiveness of the telecare platform, assessing direct costs from factors such as unanticipated cancellations on the day of surgery due to preoperative instructions not being followed, calls to the local health information line, calls to the provincial health information line, emergency department consultations, unplanned readmissions, or medical visits for problems related to the surgical procedure within the first 30 days after the intervention. The secondary outcome will be to evaluate cost utility using a questionnaire assessing quality-adjusted life years. A blinded independent research team will analyze outcomes. All data will be analyzed according to the intention-to-treat principle. A sample size of 500 subjects in each group was calculated to detect a 21% reduction in postoperative complications with a power of 90%. This study has been approved by the ethics board of Centre hospitalier de l’Université de Montréal (University of Montreal Health Centre). No employee of LeoMed was involved in the study conception, and none will be involved in either data collection or analysis. Results: Results of this trial will be useful to determine the economic benefit of a telecare platform specifically developed for surgical outpatient pathways. Conclusions: We believe that the deployment of a dedicated perioperative telehealth app will lead to better patient care and fewer postoperative complications, which will lower all types of costs related to surgical outpatient care. Trial Registration: ClinicalTrials.gov NCT04948632; https://ClinicalTrials.gov/ct2/show/NCT04948632

This pre-registered report aims to reveal whether board gender diversity enhance bank performance in a bank-based (financial) system. Using publicly listed banks in the period (2010 2021), we plan to measure bank performance and adopt a difference in difference method for the analysis. We focus on whether Japan’s Corporate Governance (CG) code strengthens the advisory or monitoring roles of women on board (WOB) in the banking industry. We shed light on the effectiveness of Japan’s CG code, which aims to increase the number of female directors. Furthermore, we contribute to the discussion of “Who monitors the monitors?” in a bank-based system.

Background: Numerous smartphone apps are targeting physical activity and healthy eating, but empirical evidence on their effectiveness for initialization and maintenance of behavior change, especially in children and adolescents, is still limited. Objective: The aim of this study was to conceptualize a theory-based and evidence-based mHealth intervention called SMARTFAMILY (SF) that targets physical activity and healthy eating in a collective family-based setting. Subsequently, the app will be refined and re-evaluated to analyze additional effects of just-in-time adaptive interventions (JITAIs) and gamification features. Methods: A smartphone app based on behavior change theories and behavior change techniques was developed and implemented and will be evaluated with family members individually and cooperatively (SF trial). Existing evidence and gained results were used to refine and will be used to re-evaluate the app (SF2.0 trial). Both trials are cluster randomized controlled trials with 3 measurement occasions. The intervention group uses the app for 3 consecutive weeks, whereas the control group receives no treatment. Baseline measurements (T0) and postintervention measurements (T1) include physical activity (ie, self-reported and accelerometry) and healthy eating measurements (ie, self-reported fruit and vegetable intake) as the primary outcomes. The secondary outcomes (ie, self-reported) are intrinsic motivation, behavior-specific self-efficacy, and the family health climate, complemented by an intentional measure in SF2.0. Four weeks following T1, a follow-up assessment (T2) is completed by the participants, consisting of all questionnaire items to assess the stability of the intervention effects. Mixed-method analysis of covariance will be used to calculate the primary intervention effects (ie, physical activity, fruit and vegetable intake) while controlling for covariates, including family health climate, behavior-specific self-efficacy, and intrinsic motivation. Results: This study is funded by the German Federal Ministry of Education and Research and ethically approved by the Karlsruhe Institute of Technology. For both trials, it is hypothesized that the apps will positively influence physical activity and healthy eating in the whole family. Furthermore, SF2.0 is expected to produce stronger effects (ie, higher effect sizes) compared to SF. SF app development and piloting are completed. Data acquisition for the SF trial is terminated and discontinued due to the COVID-19 pandemic. SF2.0 app development and piloting are completed, while data acquisition is ongoing. Participant recruitment for the SF 2.0 trial started in February 2020. The results for SF are expected to be published in mid-2021, and the results of SF2.0 are expected to be published in mid-2022. Conclusions: In this study, it is hypothesized that targeting the whole family will facilitate behavior change at the individual level and the family level, as the implemented strategies address changes in daily family life. Furthermore, subsequent app development (SF2.0) with supplementary addition of motivation-enhancing features and a JITAI approach is expected to enhance positive intervention effects. Trial Registration: German Clinical Trials Register DRKS00010415; https://tinyurl.com/yyo87yyu

This pre-registered study aims to explore the interaction between internal board structure arrangements and external stakeholder reactions. Specifically, we focus on how customers and suppliers respond to board ownership representativeness, which measures the alignment of interests between the board and the shareholders. We investigate the following questions in this study: (1) Does board ownership representativeness impact corporate trade credit? (2) If so, what is the mechanism underlying this effect? (3) What impact does the legal environment and information asymmetry have on this relationship? (4) How does board ownership representativeness interact with the role of independent directors? (5) How does the change in trade credit driven by board ownership representativeness ultimately influence a firm's performance? This study expands the research on the economic consequences of board structure from the perspective of board ownership representativeness and provides a new lens for enhancing firms' access to trade credit.

Background: Complex and expanding data sets in clinical oncology applications require flexible and interactive visualization of patient data to provide the maximum amount of information to physicians and other medical practitioners. Interdisciplinary tumor conferences in particular profit from customized tools to integrate, link, and visualize relevant data from all professions involved. Objective: The scoping review proposed in this protocol aims to identify and present currently available data visualization tools for tumor boards and related areas. The objective of the review will be to provide not only an overview of digital tools currently used in tumor board settings, but also the data included, the respective visualization solutions, and their integration into hospital processes. Methods: The planned scoping review process is based on the Arksey and O’Malley scoping study framework. The following electronic databases will be searched for articles published in English: PubMed, Web of Knowledge, and SCOPUS. Eligible articles will first undergo a deduplication step, followed by the screening of titles and abstracts. Second, a full-text screening will be used to reach the final decision about article selection. At least 2 reviewers will independently screen titles, abstracts, and full-text reports. Conflicting inclusion decisions will be resolved by a third reviewer. The remaining literature will be analyzed using a data extraction template proposed in this protocol. The template includes a variety of meta information as well as specific questions aiming to answer the research question: “What are the key features of data visualization solutions used in molecular and organ tumor boards, and how are these elements integrated and used within the clinical setting?” The findings will be compiled, charted, and presented as specified in the scoping study framework. Data for included tools may be supplemented with additional manual literature searches. The entire review process will be documented in alignment with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) flowchart. Results: The results of this scoping review will be reported per the expanded PRISMA-ScR guidelines. A preliminary search using PubMed, Web of Knowledge, and Scopus resulted in 1320 articles after deduplication that will be included in the further review process. We expect the results to be published during the second quarter of 2024. Conclusions: Visualization is a key process in leveraging a data set’s potentially available information and enabling its use in an interdisciplinary setting. The scoping review described in this protocol aims to present the status quo of visualization solutions for tumor board and clinical oncology applications and their integration into hospital processes. Trial Registration:

Background: Cardiometabolic diseases (CMDs) are a group of interrelated conditions, including heart failure and diabetes, that increase the risk of cardiovascular and metabolic complications. The rising number of Australians with CMDs has necessitated new strategies for those managing these conditions, such as digital health interventions. The effectiveness of digital health interventions in supporting people with CMDs is dependent on the extent to which users engage with the tools. Augmenting digital health interventions with conversational agents, technologies that interact with people using natural language, may enhance engagement because of their human-like attributes. To date, no systematic review has compiled evidence on how design features influence the engagement of conversational agent–enabled interventions supporting people with CMDs. This review seeks to address this gap, thereby guiding developers in creating more engaging and effective tools for CMD management. Objective: The aim of this systematic review is to synthesize evidence pertaining to conversational agent–enabled intervention design features and their impacts on the engagement of people managing CMD. Methods: The review is conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Searches will be conducted in the Ovid (Medline), Web of Science, and Scopus databases, which will be run again prior to manuscript submission. Inclusion criteria will consist of primary research studies reporting on conversational agent–enabled interventions, including measures of engagement, in adults with CMD. Data extraction will seek to capture the perspectives of people with CMD on the use of conversational agent–enabled interventions. Joanna Briggs Institute critical appraisal tools will be used to evaluate the overall quality of evidence collected. Results: This review was initiated in May 2023 and was registered with the International Prospective Register of Systematic Reviews (PROSPERO) in June 2023, prior to title and abstract screening. Full-text screening of articles was completed in July 2023 and data extraction began August 2023. Final searches were conducted in April 2024 prior to finalizing the review and the manuscript was submitted for peer review in July 2024. Conclusions: This review will synthesize diverse observations pertaining to conversational agent–enabled intervention design features and their impacts on engagement among people with CMDs. These observations can be used to guide the development of more engaging conversational agent–enabled interventions, thereby increasing the likelihood of regular intervention use and improved CMD health outcomes. Additionally, this review will identify gaps in the literature in terms of how engagement is reported, thereby highlighting areas for future exploration and supporting researchers in advancing the understanding of conversational agent–enabled interventions. Trial Registration: PROSPERO CRD42023431579; https://tinyurl.com/55cxkm26

Background: There has been a surge in mental health apps over the past few years. While these have great potential to address the unmet mental health needs of the population, the recent proliferation of mental health apps in the commercial marketplace has raised several concerns, such as privacy, evidence-based, and quality. Although there is mounting research on the effectiveness of mental health apps, the majority of these are not accessible to the public and most of those available have not been researched. Despite the rapid growth of the digital health market in India, there are no comprehensive reviews of publicly available mental health apps for Indian users. Hence it becomes important to review mental health apps freely available to potential end users in terms of their scope, functions, and quality. Objective: This study aims to systematically evaluate mental health apps available to Indian users in app stores. Methods: This systematic review of mental health apps will be performed following the Target user, Evaluation focus, Connectedness and Health domain approach and the PASSR (Protocol for App Store Systematic Reviews) checklist. Fifteen key search terms covering various mental health conditions and therapies will be used on the Android and iOS stores. The identified apps will be further screened and reviewed based on the inclusion and exclusion criteria. The pool of eligible apps will be downloaded for detailed review. The following steps will be adopted to streamline the review process and interrater consistency. Six apps will be randomly selected from the downloaded apps, for joint discussion and review by a team of 4 primary reviewers and 2 mentors. Following this, a new set of 6 randomly selected apps will be rated independently by the primary reviewers and the differences in ratings will be jointly discussed for generating consensus. Subsequently, the primary reviewers will individually review the remaining apps in the list. Data will be extracted based on predecided parameters such as privacy policy, basic purpose, type of developer, nature of intervention strategies, and guided versus unguided nature. Additionally, the apps will be reviewed for quality using the Mobile Application Rating Scale. The data analysis and synthesis strategy will incorporate descriptive statistics based on quality evaluation using the Mobile Application Rating Scale and examining the content of the apps for generating descriptive information. Results: The initial screening of mental health apps available for Indian users on the Google Play Store and Apple App Store was initiated in October 2024. We expect to complete the detailed systematic review by April 2025. Conclusions: This study will offer a comprehensive review of mental health apps available in digital marketplaces for Indian users and has implications for end users, policy makers, developers, and mental health professionals. Trial Registration: International Platform of Registered Systematic Review and Meta-analysis Protocols INPLASY2024100035; https://inplasy.com/inplasy-2024-10-0035/

Background: Digital microscopy combined with artificial intelligence (AI) is increasingly being implemented in health care, predominantly in advanced laboratory settings. However, AI-supported digital microscopy could be especially advantageous in primary health care settings, since such methods could improve access to diagnostics via automation and lead to a decreased need for experts on site. To our knowledge, no scoping or systematic review had been published on the use of AI-supported digital microscopy within primary health care laboratories when this scoping review was initiated. A scoping review can guide future research by providing insights to help navigate the challenges of implementing these novel methods in primary health care laboratories. Objective: The objective of this scoping review is to map peer-reviewed studies on AI-supported digital microscopy in primary health care laboratories to generate an overview of the subject. Methods: A systematic search of the databases PubMed, Web of Science, Embase, and IEEE will be conducted. Only peer-reviewed articles in English will be considered, and no limit on publication year will be applied. The concept inclusion criteria in the scoping review include studies that have applied AI-supported digital microscopy with the aim of achieving a diagnosis on the subject level. In addition, the studies must have been performed in the context of primary health care laboratories, as defined by the criteria of not having a pathologist on site and using simple sample preparations. The study selection and data extraction will be performed by 2 independent researchers, and in the case of disagreements, a third researcher will be involved. The results will be presented in a table developed by the researchers, including information on investigated diseases, sample collection, preparation and digitization, AI model used, and results. Furthermore, the results will be described narratively to provide an overview of the studies included. The proposed methodology is in accordance with the JBI methodology for scoping reviews. Results: The scoping review was initiated in January 2023, and a protocol was published in the Open Science Framework in January 2024. The protocol was completed in March 2024, and the systematic search will be performed after the protocol has been peer reviewed. The scoping review is expected to be finalized by the end of 2024. Conclusions: A systematic review of studies on AI-supported digital microscopy in primary health care laboratories is anticipated to identify the diseases where these novel methods could be advantageous, along with the shared challenges encountered and approaches taken to address them.

Background: The Extension for Community Health Outcomes (ECHO) Autism Program trains clinicians to screen, diagnose, and care for children with autism spectrum disorder (ASD) in primary care settings. This study will assess the feasibility and impact of integrating an artificial intelligence (AI)–based ASD diagnosis aid (the device) into the existing ECHO Autism Screening Tool for Autism in Toddlers and Young Children (STAT) diagnosis model. The prescription-only Software as a Medical Device, designed for use in children aged 18 to 72 months at risk for developmental delay, produces ASD diagnostic recommendations after analyzing behavioral features from 3 distinct inputs: a caregiver questionnaire, 2 short home videos analyzed by trained video analysts, and a health care provider questionnaire. The device is not a stand-alone diagnostic and should be used in conjunction with clinical judgment. Objective: This study aims to assess the feasibility and impact of integrating an AI-based ASD diagnosis aid into the ECHO Autism STAT diagnosis model. The time from initial ECHO Autism clinician concern to ASD diagnosis is the primary end point. Secondary end points include the time from initial caregiver concern to ASD diagnosis, time from diagnosis to treatment initiation, and clinician and caregiver experience of device use as part of the ASD diagnostic journey. Methods: Research participants for this prospective observational study will be patients suspected of having ASD (aged 18-72 months) and their caregivers and up to 15 trained ECHO Autism clinicians recruited by the ECHO Autism Communities research team from across rural and suburban areas of the United States. Clinicians will provide routine clinical care and conduct best practice ECHO Autism diagnostic evaluations in addition to prescribing the device. Outcome data will be collected via a combination of electronic questionnaires, reviews of standard clinical care records, and analysis of device outputs. The expected study duration is no more than 12 months. The study was approved by the institutional review board of the University of Missouri-Columbia (institutional review board–assigned project number 2075722). Results: Participant recruitment began in April 2022. As of June 2022, a total of 41 participants have been enrolled. Conclusions: This prospective observational study will be the first to evaluate the use of a novel AI-based ASD diagnosis aid as part of a real-world primary care diagnostic pathway. If device integration into primary care proves feasible and efficacious, prolonged delays between the first ASD concern and eventual diagnosis may be reduced. Streamlining primary care ASD diagnosis could potentially reduce the strain on specialty services and allow a greater proportion of children to commence early intervention during a critical neurodevelopmental window. Trial Registration: ClinicalTrials.gov NCT05223374; https://clinicaltrials.gov/ct2/show/NCT05223374

A fundamental principle of responsible scientific research is replication. Replication provides independent verification of previously reported findings and improves our understanding of observed phenomena by removing researcher bias, strengthening existing evidence and questioning past conclusions. Replication is an essential component of the self-correcting nature of science but, for too long the scientific community has overlooked the benefits of replication due to its perceived lack of novelty. However, a shift in attitudes has been making its way through various scientific disciplines, with finance now having its turn. In this study we survey the authors of Pacific-Basin Finance Journal replication studies to explore their motivations, experiences and seek their feedback on the specific process utilized by the journal to undertake the important task of facilitating the publication of replications.

Background: Sexual minority women are more likely to drink alcohol, engage in heavy drinking, and experience alcohol-related problems than heterosexual women. However, culturally tailored interventions for this population have been slow to emerge. Objective: This type 1 effectiveness-implementation trial examines the feasibility and efficacy of a gamified, culturally tailored, personalized normative feedback (PNF) alcohol intervention for sexual minority women who psychologically identify as lesbian, bisexual, or queer (LBQ). Methods: The core components of a PNF intervention were delivered within LezParlay, a fun, social media–inspired, digital competition designed to challenge negative stereotypes about LBQ women and increase visibility. The competition was advertised on the web through social media platforms and collaboration with LBQ community organizations. After 2 rounds of play by a large cohort of LBQ women, a subsample of 500 drinkers already taking part in the competition were invited to participate in the evaluation study. Study participants were randomized to receive 1 of 3 unique sequences of PNF (ie, alcohol and stigma coping, alcohol and control, or control topics only) over 2 intervention rounds. Randomization was fully automated by the web app, and both researchers and participants were blinded. Results: Analyses will evaluate whether PNF on alcohol use reduces participants’ drinking and negative consequences at 2 and 4 months postintervention; examine whether providing PNF on stigma-coping behaviors, in addition to alcohol use, further reduces alcohol use and consequences beyond PNF on alcohol alone; identify mediators and moderators of intervention efficacy; and examine broader LezParlay app engagement, acceptability, and perceived benefits. Conclusions: This incognito intervention approach is uniquely oriented toward engaging and preventing alcohol-related risks among community populations of LBQ women who may view their heavy drinking as normative and not in need of change because of the visibility of alcohol use in sexual minority community spaces. Thus, this intervention strategy diverges from, and is intended to complement, more intensive programs being developed to meet the needs of LBQ women already motivated to reduce their consumption. Trial Registration: ClinicalTrials.gov NCT03884478; https://clinicaltrials.gov/ct2/show/NCT03884478

Background: Many emerging adults (EAs) are prone to making unhealthy choices, which increase their risk of premature cancer morbidity and mortality. In the era of social media, rigorous research on interventions to promote health behaviors for cancer risk reduction among EAs delivered over social media is limited. Cancer prevention information and recommendations may reach EAs more effectively over social media than in settings such as health care, schools, and workplaces, particularly for EAs residing in rural areas. Objective: This pragmatic randomized trial aims to evaluate a multirisk factor intervention using a social media campaign designed with community advisers aimed at decreasing cancer risk factors among EAs. The trial will target EAs from diverse backgrounds living in rural counties in the Four Corners states of Arizona, Colorado, New Mexico, and Utah. Methods: We will recruit a sample of EAs (n=1000) aged 18 to 26 years residing in rural counties (Rural-Urban Continuum Codes 4 to 9) in the Four Corners states from the Qualtrics’ research panel and enroll them in a randomized stepped-wedge, quasi-experimental design. The inclusion criteria include English proficiency and regular social media engagement. A social media intervention will promote guideline-related goals for increased physical activity, healthy eating, and human papillomavirus vaccination and reduced nicotine product use, alcohol intake, and solar UV radiation exposure. Campaign posts will cover digital and media literacy skills, responses to misinformation, communication with family and friends, and referral to community resources. The intervention will be delivered over 12 months in Facebook private groups and will be guided by advisory groups of community stakeholders and EAs and focus groups with EAs. The EAs will complete assessments at baseline and at 12, 26, 39, 52, and 104 weeks after randomization. Assessments will measure 6 cancer risk behaviors, theoretical mediators, and participants’ engagement with the social media campaign. Results: The trial is in its start-up phase. It is being led by a steering committee. Team members are working in 3 subcommittees to optimize community engagement, the social media intervention, and the measures to be used. The Stakeholder Organization Advisory Board and Emerging Adult Advisory Board were formed and provided initial input on the priority of cancer risk factors to target, social media use by EAs, and community resources available. A framework for the social media campaign with topics, format, and theoretical mediators has been created, along with protocols for campaign management. Conclusions: Social media can be used as a platform to counter misinformation and improve reliable health information to promote health behaviors that reduce cancer risks among EAs. Because of the popularity of web-based information sources among EAs, an innovative, multirisk factor intervention using a social media campaign has the potential to reduce their cancer risk behaviors. Trial Registration: ClinicalTrials.gov NCT05618158; https://classic.clinicaltrials.gov/ct2/show/NCT05618158

Exercise and mindfulness-based interventions have growing evidence for managing fatigue and comorbid symptoms; however, packaging them in a cohesive digital way for patients undergoing cancer treatment has not been evaluated. We conducted a randomized controlled trial to assess the impact of a 12 week digital integrative medicine program, Integrative Medicine at Home (IM@Home), versus enhanced usual care on fatigue severity (primary outcome), comorbid symptoms and acute healthcare utilization (secondary outcomes), in 200 patients with solid tumors experiencing fatigue during treatment. Fatigue severity decreased more in IM@Home than in the control (1.99 vs. 1.51 points; p = 0.04). IM@Home participants also had reduced symptom distress (p = 0.003), anxiety (p = 0.03), and depression (p = 0.02). Acute healthcare utilization was lower with IM@Home, with fewer emergency department visits (rate ratio 0.49; p = 0.04), hospitalizations (4% vs. 12.9%; p = 0.03), and shorter hospital stays (4.25 vs. 10 days; p < 0.001). These promising findings should be confirmed in phase III clinical trials. “Study registered at clinicaltrials.gov (NCT05053230) on 09-20-2021”.

This study aims to test the interplay between task and information conflicts in the Stroop task. Specifically, we will measure task conflict (RTneutral words − RTneutral shapes) while controlling for frequency and contingency learning effects. By doing so, the current study will resolve inconsistencies and potential confounds that existed in previous studies. We will recruit 500 participants who will perform the color-word Stroop task and will be randomized to one of four different groups: mostly words with congruent trials, mostly symbols with congruent trials, mostly words with incongruent trials, and mostly symbols with incongruent trials and task conflict will be measured in each group. We predict a strong task conflict in the mostly symbols with congruent condition, indicating that task conflict can manifest independently of information conflict. Additionally, we expect an increased task conflict marker in the presence of incongruent trials, indicating that information conflict enhances task control activation.

ABSTRACT Outgroup bias is well-documented and pernicious, manifesting in negative attitudes and behavior towards outgroups. Addressing it is a first-order priority for Diversity, Equity and Inclusion programs, as well as society more generally. Empathy---taking the perspective and understanding the experiences of others---holds promise for attenuating outgroup bias, but existing methods are expensive. Through seven pilots, we develop a low-cost, easily scalable ``peer praise” intervention that encourages empathy. In this report, we test whether our intervention promotes empathy and inclusive behavior/attitudes among white U.S. respondents towards Black and Latino/a Americans, a context where outgroup bias is particularly durable. We measure costly choices to engage in empathy, test whether peer praise promotes political and attitudinal inclusion, and if praise specifically from co-partisans can also promote inclusion. Finally, we test if these effects endure over time, vary by partisanship and function through potential mechanisms such as happiness and norms. ITEMS Stage 1 Registered Report Protocol Stage 1 Registered Report Supplementary Information Stage 1 Registered Report Reporting Summary

Background: Less than one-third of women gain an appropriate amount of weight during pregnancy, which can influence the long-term health of both the mother and the child. Economically disadvantaged women are the most vulnerable to maternal obesity, excessive weight gain during pregnancy, and poor birth outcomes. Effective and scalable health care strategies to promote healthy weight gain during pregnancy specifically tailored for these women are lacking. Objective: This paper presents the design and protocol of a biphasic, community-based eHealth trial, SmartMoms in WIC, to increase the adherence to healthy gestational weight gain (GWG) recommendations in low-income mothers receiving women, infant, and children (WIC) benefits. Methods: Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits. The health curriculum, the format of delivery, and incentive strategies were adapted to be culturally relevant and at an appropriate level of health literacy. Phase 2 included a pragmatic randomized controlled trial across the 9 health care regions in Louisiana with the goal of enrolling 432 women. The SmartMoms in WIC intervention is an intensive 24-week behavioral intervention, which includes nutrition education and exercise strategies, and provides the technology to assist with weight management, delivered through a professionally produced website application. Results: Phase 1 of this trial was completed in July 2019, and recruitment for phase 2 began immediately thereafter. All data are anticipated to be collected by Spring 2023. Conclusions: The SmartMoms in WIC curriculum was methodically developed using feedback from community-based peer advisory groups to create a culturally relevant, mobile behavioral intervention for mothers receiving WIC benefits. The randomized clinical trial is underway to test the effectiveness of a sustainable eHealth program on the incidence rates of appropriate GWG. SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC. Trial Registration: ClinicalTrials.gov NCT04028843; https://clinicaltrials.gov/ct2/show/NCT04028843

Despite the increasing use of pharmacological and bariatric surgery to treat obesity, weight-loss lifestyle intervention remains the first-line treatment. Digital health is coming to meet individual needs and makes obesity treatment more accessible, so this work aims to evaluate the safety and performance of a Digital Therapy for Obesity App (DTxO) in improving weight loss and weight-loss maintenance in obese patients exposed to an experimental nonpharmacological treatment program. Here we present the study protocol of a prospective, multicenter, pragmatic, randomized, double-arm, placebo-controlled, parallel, single-blind study on obese patients who will be treated with a new digital therapy to obtain an improvement in their disease condition through the application of different simultaneous strategies (a dietary plan and customized advice program, a customized physical exercise program plan, a cognitive–behavioural assessment and program, alerts and reminders, dedicated section on prescribed drugs intake, and chat and online visits with clinical professionals). We believe that DTxO will offer a promising intervention channel and self-regulation tool holding the potential to reduce treatment burden and reach more people by replacing some in-person contact with phone or digital communication, improving self-engagement and reducing the high demands the “obesity pandemic” for both patients and national health services in terms of time, cost, and effort.

Background: Digital health twins (DHTs) have been evolving with their diverse applications in medicine, specifically in older care settings, with the increasing demands of older adults. DHTs have already contributed to improving the quality of dementia and trauma care, cardiac treatment, and health care services for older individuals. Despite its many benefits, the optimum implementation of DHTs has faced several challenges associated with ethical issues, quality of care, management and leadership, and design considerations in older care settings. Since the need for such care is continuously rising and there is evident potential for DHTs to meet those needs, this review aims to map key concepts to address the gaps in the research knowledge to improve DHT implementation. Objective: The review aims to compile and synthesize the best available evidence regarding the problems encountered by older adults and care providers associated with the application of DHTs. The synthesis will collate the evidence of the issues associated with quality of care, the ethical implications of DHTs, and the strategies undertaken to overcome those challenges in older care settings. Methods: The review will follow the Joanna Briggs Institute (JBI) methodology. The published studies will be searched through CINAHL, MEDLINE, JBI, and Web of Science, and the unpublished studies through Mednar, Trove, OCLC WorldCat, and Dissertations and Theses. Studies published in English from 2002 will be considered. This review will include studies of older individuals (aged 65 years or older) undergoing care delivery associated with DHTs and their respective care providers. The concept will include the application of the technology, and the context will involve studies based on the older care setting. A broad scope of evidence, including quantitative, qualitative, text and opinion studies, will be considered. A total of 2 independent reviewers will screen the titles and abstracts and then review the full text. Data will be extracted from the included studies using a data extraction tool developed for this study. Results: The results will be presented in a PRISMA-ScR (Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews) flow diagram. A draft charting table will be developed as a data extraction tool. The results will be presented as a “map” of the data in a logical, diagrammatic, or tabular form in a descriptive format. Conclusions: The evidence synthesis is expected to uncover the shreds of evidence required to address the ethical and care quality-related challenges associated with applying DHTs. A synthesis of various strategies used to overcome identified challenges will provide more prospects for adopting them elsewhere and create a resource allocation model for older individuals.

Background: Young racial and ethnic minority men who have sex with men (MSM) and trans women are disproportionately affected by HIV and AIDS in the United States. Unrecognized infection, due to a low uptake of HIV testing, and poor linkage to care are driving forces of ongoing HIV transmission among young racial and ethnic minority MSM and trans women. Internet and mobile technologies, in combination with social network-based approaches, offer great potential to overcome and address barriers to care and effectively disseminate interventions. Objective: We describe Health eNavigation (Health eNav), a digital HIV care navigation intervention that extends supportive care structures beyond clinic walls to serve youth and young adults living with HIV who are newly diagnosed, not linked to care, out of care, and not virally suppressed, at times when they need support the most. Methods: This study leverages ecological momentary assessments for a period of 90 days and uses person-delivered short message service text messages to provide participants with digital HIV care navigation over a 6-month period. We aim to improve engagement, linkage, and retention in HIV care and improve viral suppression. Digital HIV care navigation includes the following components: (1) HIV care navigation, (2) health promotion, (3) motivational interviewing, and (4) digital social support. Results: Recruitment began on November 18, 2016; enrollment closed on May 31, 2018. Intervention delivery ended on November 30, 2018, and follow-up evaluations concluded on October 31, 2019. In this paper, we present baseline sample characteristics. Conclusions: We discuss real-world strategies and challenges in delivering the digital HIV care navigation intervention in a city-level, public health setting.

Background: Excessive gestational weight gain is common and associated with adverse outcomes both in the short and long term. Although traditional lifestyle-based interventions have shown to mitigate excess gestational weight gain, little is known about whether mobile Health (mHealth) apps can promote healthy weight gain, diet, and physical activity during pregnancy. Objective: The primary aim of the HealthyMoms trial is to determine the effectiveness of a smartphone app (HealthyMoms) for mitigating excess gestational weight gain during pregnancy. Secondary aims are to determine the effectiveness of the app on dietary habits, physical activity, body fatness, and glycemia during pregnancy. Methods: HealthyMoms is a two-arm randomized controlled trial. Women are being recruited at routine visits at the maternity clinics in Linköping, Norrköping and Motala, Sweden. Women are randomized to the control or intervention group (n=150 per group). All women will receive standard care, and women in the intervention group will also receive the HealthyMoms smartphone app. Results: Recruitment of participants to the trial was initiated in October 2017, and 190 women have so far completed the baseline measurement. The baseline measures are estimated to be finalized in December 2019, and the follow-up measures are estimated to be completed in June 2020. Conclusions: This project will evaluate a novel smartphone app intervention integrated with existing maternity health care. If successful, it has great potential to be implemented nationally in order to promote healthy weight gain and health behaviors during pregnancy. International Registered Report Identifier (IRRID): DERR1-10.2196/13011