International Registered Report Identifier Research Articles

Personalized AI-Driven Real-Time Models to Predict Stress-Induced Blood Pressure Spikes Using Wearable Devices: Proposal for a Prospective Cohort Study

Background Referred to as the “silent killer,” elevated blood pressure (BP) often goes unnoticed due to the absence of apparent symptoms, resulting in cumulative harm over time. Chronic stress has been consistently linked to increased BP. Prior studies have found that elevated BP often arises due to a stressful lifestyle, although the effect of exact stressors varies drastically between individuals. The heterogeneous nature of both the stress and BP response to a multitude of lifestyle decisions can make it difficult if not impossible to pinpoint the most deleterious behaviors using the traditional mechanism of clinical interviews. Objective The aim of this study is to leverage machine learning (ML) algorithms for real-time predictions of stress-induced BP spikes using consumer wearable devices such as Fitbit, providing actionable insights to both patients and clinicians to improve diagnostics and enable proactive health monitoring. This study also seeks to address the significant challenges in identifying specific deleterious behaviors associated with stress-induced hypertension through the development of personalized artificial intelligence models for individual patients, departing from the conventional approach of using generalized models. Methods The study proposes the development of ML algorithms to analyze biosignals obtained from these wearable devices, aiming to make real-time predictions about BP spikes. Given the longitudinal nature of the data set comprising time-series data from wearables (eg, Fitbit) and corresponding time-stamped labels representing stress levels from Ecological Momentary Assessment reports, the adoption of self-supervised learning for pretraining the network and using transformer models for fine-tuning the model on a personalized prediction task is proposed. Transformer models, with their self-attention mechanisms, dynamically weigh the importance of different time steps, enabling the model to focus on relevant temporal features and dependencies, facilitating accurate prediction. Results Supported as a pilot project from the Robert C Perry Fund of the Hawaii Community Foundation, the study team has developed the core study app, CardioMate. CardioMate not only reminds participants to initiate BP readings using an Omron HeartGuide wearable monitor but also prompts them multiple times a day to report stress levels. Additionally, it collects other useful information including medications, environmental conditions, and daily interactions. Through the app’s messaging system, efficient contact and interaction between users and study admins ensure smooth progress. Conclusions Personalized ML when applied to biosignals offers the potential for real-time digital health interventions for chronic stress and its symptoms. The project’s clinical use for Hawaiians with stress-induced high BP combined with its methodological innovation of personalized artificial intelligence models highlights its significance in advancing health care interventions. Through iterative refinement and optimization, the aim is to develop a personalized deep-learning framework capable of accurately predicting stress-induced BP spikes, thereby promoting individual well-being and health outcomes. International Registered Report Identifier (IRRID) DERR1-10.2196/55615

Implementation Documentation and Process Assessment of the PharmNet Intervention: Observational Report.

The number of overdose deaths in the United States involving opioids continues to exceed 100,000 per year. This has precipitated ongoing declarations of a public health emergency. Harm reduction approaches, such as promoting awareness of, ensuring access to, and fostering willingness to use naloxone to reverse opioid overdose, are a key component of a larger national strategy to address the crisis. In addition, overdose reversal with naloxone directly and immediately saves lives. Because of pharmacies' ubiquity and pharmacists' extensive clinical training, community pharmacies are well-positioned, in principle, to facilitate naloxone access and education. In 2022, a single-site pilot study of PharmNet, a community pharmacy intervention incorporating naloxone distribution, awareness building, and referral, showed promising outcomes for both naloxone and resource distribution in the community. As a next step, this study was intended to be a pilot randomized controlled trial of PharmNet in 7 pharmacies. However, due to circumstances outside of the study team's control, data collection was unable to be fully completed as planned. In keeping with open research standards, we transparently report all available data from the study and discuss trial barriers and processes. We do so both to provide insights that may inform similar studies and to avoid the "file-drawer" (publication bias) problem, which can skew the aggregated scholarly literature through nonpublication of registered trial results or selective publication of findings affirming authors' hypotheses. This paper reports an in-depth implementation study assessment, provides the available observational data, and discusses implementation considerations for similar studies in independent (eg, nonchain) community pharmacies. Retrospective assessment of study outcomes and fidelity data provided for robust discussion around how resource differences in independent community pharmacies (vs well-resourced chain pharmacies), as well as high demands on staff, can affect intervention implementation, even when leadership is highly supportive. Community pharmacies, particularly independent community pharmacies, may require more support than anticipated to be successful when implementing a new intervention into practice, even if it might affect estimates of real-world effectiveness. Further implementation science research is needed specific to independent community pharmacies. All study elements are outlined in the International Registered Report Identifier (IRRID) PRR1-10.2196/42373. Although this paper reports results associated with that registration, results and conclusions should not be given the weight assigned to findings from a preregistered study. RR2-10.2196/42373.

Interactive Narrative-Based Digital Health Interventions for Vaccine Communication: Protocol for a Scoping Review.

Interactive narrative-based digital health interventions hold promise for effectively addressing the complex determinants of vaccine hesitancy and promoting effective communication across a wide range of settings and vaccine types. Synthesizing evidence related to the implementation and evaluation of these interventions could offer valuable perspectives for shaping future strategies in vaccine communication. Prior systematic and scoping reviews have examined narrative-based vaccine communication interventions but not the inclusion of interactivity in such interventions. The overall objective of the scoping review is to summarize the evidence on the use of interactive narrative-based digital health interventions for vaccine communication. Specific research questions focus on describing the use of interactive narrative-based digital health interventions (RQ1), describing evaluations of the impact of interactive narrative-based digital health interventions on promoting vaccine uptake (RQ2), and factors associated with their implementation (RQ3). A detailed search string will be used to search the following databases for records that are relevant to the review questions: PubMed, Embase, Scopus, Web of Science, CINAHL, and PsycINFO. Two reviewers will independently screen the titles and abstracts of identified records against the predefined eligibility criteria. Subsequently, eligible records will undergo comprehensive full-text screening by 2 independent reviewers to assess their relevance to review questions. A data charting tool will be developed and used to extract relevant information from the included articles. The extracted information will be analyzed following the review questions and presented as a narrative summary. Tabular or graphical representations will be used to display review findings, as relevant. Public health informationists were consulted to develop the detailed search strategy. The final search string comprised terms related to narrative communication, digital health, and vaccines. The search string was customized to each proposed publication database and implemented on April 18, 2023. A total of 4474 unique records were identified using the search strategy and imported into the Covidence (Veritas Health Innovation Ltd) review management software for title and abstract screening. Title and abstract screening of identified records are ongoing as of December 29, 2023. To our knowledge, this will be the first scoping review to investigate the features of interactive narrative-based digital health interventions and their role in vaccine communication. The goal of this study is to provide a comprehensive overview of the current research landscape and identify prevailing gaps in knowledge. The findings will provide insights for future research and development of novel applications of interactive narrative-based digital health vaccine communication interventions. DERR1-10.2196/51137.

Drug Repurposing for Cancers With Limited Survival: Protocol for a Retrospective Cohort Study.

Only 5% of the molecules tested in oncology phase 1 trials reach the market after an average of 7.5 years of waiting and at a cost of tens of millions of dollars. To reduce the cost and shorten the time of discovery of new treatments, "drug repurposing" (research with molecules already approved for another indication) and the use of secondary data (not collected for the purpose of research) have been proposed. Due to advances in informatics in clinical care, secondary data can, in some cases, be of equal quality to primary data generated through prospective studies. The objective of this study is to identify drugs currently marketed for other indications that may have an effect on the prognosis of patients with cancer. We plan to monitor a cohort of patients with high-lethality cancers treated in the public health system of Catalonia between 2006 and 2012, retrospectively, for survival for 5 years after diagnosis or until death. A control cohort, comprising people without cancer, will also be retrospectively monitored for 5 years. The following study variables will be extracted from different population databases: type of cancer (patients with cancer cohort), date and cause of death, pharmacological treatment, sex, age, and place of residence. During the first stage of statistical analysis of the patients with cancer cohort, the drugs consumed by the long-term survivors (alive at 5 years) will be compared with those consumed by nonsurvivors. In the second stage, the survival associated with the consumption of each relevant drug will be analyzed. For the analyses, groups will be matched for potentially confounding variables, and multivariate analyses will be performed to adjust for residual confounding variables if necessary. The control cohort will be used to verify whether the associations found are exclusive to patients with cancer or whether they also occur in patients without cancer. We anticipate discovering multiple significant associations between commonly used drugs and the survival outcomes of patients with cancer. We expect to publish the initial results in the first half of 2024. This retrospective study may identify several commonly used drugs as candidates for repurposing in the treatment of various cancers. All analyses are considered exploratory; therefore, the results will have to be confirmed in subsequent clinical trials. However, the results of this study may accelerate drug discovery in oncology. DERR1-10.2196/48925.

Robotics in Nursing: Protocol for a Scoping Review.

Globally, health care systems are challenged with the shortage of health care professionals, particularly nurses. The decline in the nursing workforce is primarily attributed to an aging population, increased demand for health care services, and a shortage of qualified nurses. Stressful working conditions have also increased the physical and emotional demands and perceptions of burnout, leading to attrition among nurses. Robotics has the potential to alleviate some of the workforce challenges by augmenting and supporting nurses in their roles; however, the impact of robotics on nurses is an understudied topic, and limited literature exists. We aim to understand the extent and type of evidence in relation to robotics integration in nursing practice. The Joanna Briggs Institute methodology and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist will guide the scoping review. The MEDLINE (Ovid), Embase (Ovid), CINAHL Plus with Full Text (EBSCOhost), Scopus, Cochrane Library, and IEEE Xplore electronic bibliographic databases will be searched to retrieve papers. In addition, gray literature sources, including Google Scholar, dissertations, theses, registries, blogs, and relevant organizational websites will be searched. Furthermore, the reference lists of included studies retrieved from the databases and the gray literature will be hand-searched to ensure relevant papers are not missed. In total, 2 reviewers will independently screen retrieve papers at each stage of the screening process and independently extract data from the included studies. A third reviewer will be consulted to help decision-making if conflicts arise. Data analysis will be completed using both descriptive statistics and content analysis. The results will be presented using tabular and narrative formats. The review is expected to describe the current evidence on the integration and impact of robots and robotics into nursing clinical practice, provide insights into the current state and knowledge gaps, identify a direction for future research, and inform policy and practice. The authors expect to begin the data searches in late January 2024. The robotics industry is evolving rapidly, providing different solutions that promise to revamp health care delivery with possible improvements to nursing practice. This review protocol outlines the steps proposed to systematically investigate this topic and provides an opportunity for more insights from scholars and researchers working in the field. PRR1-10.2196/50626.

Designing Implementation Strategies for a Digital Suicide Safety Planning Intervention in a Psychiatric Emergency Department: Protocol for a Multimethod Research Project.

Suicide prevention is currently a national health priority in Canada. Emergency departments (EDs) are critical settings for suicide prevention, and in our local psychiatric ED at the Centre for Addiction and Mental Health, we plan to embed an app-based tool called the Hope app to support suicide safety planning intervention. The app is free and available on app stores, and usability tests have been completed. As a next step to embed this new tool into the routine clinical workflow, research is needed to assess determinants of and design strategies for implementation with the end goal of routinization. The purpose of this 2-phased research is to implement the app in the routine clinical workflow in our local psychiatric ED. The specific objectives are as follows: (1) understanding ED clinicians' perceptions and experience of implementing the app in routine practice and identifying barriers to and facilitators of implementation (phase 1) and (2) using findings and outputs from phase 1 and collaborating with service users, families, and ED clinicians to co-design implementation strategies for the app (phase 2). We will use an integrated knowledge translation approach throughout this project. In phase 1, we will conduct interviews with ED clinicians to identify implementation determinants using a behavior change framework. In phase 2, a co-design team comprising clinicians, ED service users, and families will design implementation strategies that align with the determinants identified in phase 1. This protocol presents detailed information about the entire structure of the 2-phased research project. Ethics approval for conducting the qualitative descriptive study (phase 1) has been obtained, and the recruitment and data collection processes will be completed no later than December 2023. Ethics approval for phase 2 is underway. Involving multiple knowledge user groups early in the research and decision-making process is crucial for successful implementation. Although co-designing is commonly practiced during innovation development, there is often a misconception that the responsibility for implementing what has been designed falls on others. This research aims to fill this methodological gap in the health informatics literature. By the end of this project, we will have developed theory-informed implementation strategies to support Centre for Addiction and Mental Health ED clinicians in adopting the Hope app to complete safety planning intervention. These strategies, guided by a behavior change framework, will target clinicians' behavior change and seamlessly integrate the app into the routine clinical workflow. In addition, this research project will provide recommendations on how to involve multiple knowledge user groups and offer insights into how the methodology used can be adapted to other areas within the health informatics literature. PRR1-10.2196/50643.

Built Environments to Support Rehabilitation for People With Stroke From the Hospital to the Home (B-Sure): Protocol for a Mixed Method Participatory Co-Design Study.

A global trend is to move rehabilitation closer to people's neighborhoods and homes. Still, little attention has been given to how the built environment outside the hospital setting might impact rehabilitation and recovery for stroke survivors. The overarching objective of this project is to develop conceptual models of built environments that support stroke rehabilitation and recovery outside the hospital setting. Specifically, the project will explore factors and characteristics of the built environment that support people with stroke and their families and identify innovative built environments that can be designed for local health care. The project will examine facilitators and obstacles for implementing built environmental solutions and evaluate the potential benefits, feasibility, and acceptability. The project uses a mixed methods design approach with 3 phases. In phase 1, factors and characteristics of the built environment for rehabilitation will be identified. Based on the results from phase 1, phase 2 will involve co-designing prototypes of environments to support the rehabilitation process for people with stroke. Finally, the prototypes will be evaluated in phase 3. Qualitative and quantitative methods will include a literature review, a concept mapping (CM) study, stakeholder interviews, prototype development, and testing. The project will use multidimensional scaling, hierarchical cluster analysis, descriptive statistics for quantitative data, and content analysis for qualitative data. Location analysis will rely on the location-allocation model for network problems, and the rule-based analysis will be based on geographic information systems data. As of the submission of this protocol, ethical approval for the CM study and the interview study has been obtained. Data collection is planned to start in September 2023 and the workshops later in the same year. The scoping review is ongoing from January 2023. The CM study is ongoing and will be finalized in the spring of 2024. We expect to finish the data analysis in the second half of 2024. The project is a 3-year project and will continue until December 2025. We aim to determine how new environments could better support a person's control over their day, environment, goals, and ultimately control over their recovery and rehabilitation activities. This "taking charge" approach would have the greatest chance of transferring the care closer to the patient's home. By co-designing with multiple stakeholders, we aim to create solutions with the potential for rapid implementation. The project's outcomes may target other people with frail health after a hospital stay or older persons in Sweden and anywhere else. The impact and social benefits include collaboration between important stakeholders to explore how new environments can support the transition to local health care, co-design, and test of new conceptual models of environments that can promote health and well-being for people post stroke. DERR1-10.2196/52489.

Clinical Prediction Models for Hospital-Induced Delirium Using Structured and Unstructured Electronic Health Record Data: Protocol for a Development and Validation Study.

Hospital-induced delirium is one of the most common and costly iatrogenic conditions, and its incidence is predicted to increase as the population of the United States ages. An academic and clinical interdisciplinary systems approach is needed to reduce the frequency and impact of hospital-induced delirium. The long-term goal of our research is to enhance the safety of hospitalized older adults by reducing iatrogenic conditions through an effective learning health system. In this study, we will develop models for predicting hospital-induced delirium. In order to accomplish this objective, we will create a computable phenotype for our outcome (hospital-induced delirium), design an expert-based traditional logistic regression model, leverage machine learning techniques to generate a model using structured data, and use machine learning and natural language processing to produce an integrated model with components from both structured data and text data. This study will explore text-based data, such as nursing notes, to improve the predictive capability of prognostic models for hospital-induced delirium. By using supervised and unsupervised text mining in addition to structured data, we will examine multiple types of information in electronic health record data to predict medical-surgical patient risk of developing delirium. Development and validation will be compliant to the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement. Work on this project will take place through March 2024. For this study, we will use data from approximately 332,230 encounters that occurred between January 2012 to May 2021. Findings from this project will be disseminated at scientific conferences and in peer-reviewed journals. Success in this study will yield a durable, high-performing research-data infrastructure that will process, extract, and analyze clinical text data in near real time. This model has the potential to be integrated into the electronic health record and provide point-of-care decision support to prevent harm and improve quality of care. DERR1-10.2196/48521.

A Framework to Guide Implementation of AI in Health Care: Protocol for a Cocreation Research Project.

Artificial intelligence (AI) has the potential in health care to transform patient care and administrative processes, yet health care has been slow to adopt AI due to many types of barriers. Implementation science has shown the importance of structured implementation processes to overcome implementation barriers. However, there is a lack of knowledge and tools to guide such processes when implementing AI-based applications in health care. The aim of this protocol is to describe the development, testing, and evaluation of a framework, "Artificial Intelligence-Quality Implementation Framework" (AI-QIF), intended to guide decisions and activities related to the implementation of various AI-based applications in health care. The paper outlines the development of an AI implementation framework for broad use in health care based on the Quality Implementation Framework (QIF). QIF is a process model developed in implementation science. The model guides the user to consider implementation-related issues in a step-by-step design and plan and perform activities that support implementation. This framework was chosen for its adaptability, usability, broad scope, and detailed guidance concerning important activities and considerations for successful implementation. The development will proceed in 5 phases with primarily qualitative methods being used. The process starts with phase I, in which an AI-adapted version of QIF is created (AI-QIF). Phase II will produce a digital mockup of the AI-QIF. Phase III will involve the development of a prototype of the AI-QIF with an intuitive user interface. Phase IV is dedicated to usability testing of the prototype in health care environments. Phase V will focus on evaluating the usability and effectiveness of the AI-QIF. Cocreation is a guiding principle for the project and is an important aspect in 4 of the 5 development phases. The cocreation process will enable the use of both on research-based and practice-based knowledge. The project is being conducted within the frame of a larger research program, with the overall objective of developing theoretically and empirically informed frameworks to support AI implementation in routine health care. The program was launched in 2021 and has carried out numerous research activities. The development of AI-QIF as a tool to guide the implementation of AI-based applications in health care will draw on knowledge and experience acquired from these activities. The framework is being developed over 2 years, from January 2023 to December 2024. It is under continuous development and refinement. The development of the AI implementation framework, AI-QIF, described in this study protocol aims to facilitate the implementation of AI-based applications in health care based on the premise that implementation processes benefit from being well-prepared and structured. The framework will be coproduced to enhance its relevance, validity, usefulness, and potential value for application in practice. DERR1-10.2196/50216.

Participant Engagement and Adherence to Providing Smartwatch and Patient-Reported Outcome Data: Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Real-World Study.

Digital health studies using electronic patient-reported outcomes (ePROs) and wearables bring new challenges, including the need for participants to consistently provide trial data. This study aims to characterize the engagement, protocol adherence, and data completeness among participants with rheumatoid arthritis enrolled in the Digital Tracking of Arthritis Longitudinally (DIGITAL) study. Participants were invited to participate in this app-based study, which included a 14-day run-in and an 84-day main study. In the run-in period, data were collected via the ArthritisPower mobile app to increase app familiarity and identify the individuals who were motivated to participate. Successful completers of the run-in period were mailed a wearable smartwatch, and automated and manual prompts were sent to participants, reminding them to complete app input or regularly wear and synchronize devices, respectively, during the main study. Study coordinators monitored participant data and contacted participants via email, SMS text messaging, and phone to resolve adherence issues per a priori rules, in which consecutive spans of missing data triggered participant contact. Adherence to data collection during the main study period was defined as providing requested data for >70% of 84 days (daily ePRO, ≥80% daily smartwatch data) or at least 9 of 12 weeks (weekly ePRO). Of the 470 participants expressing initial interest, 278 (59.1%) completed the run-in period and qualified for the main study. Over the 12-week main study period, 87.4% (243/278) of participants met the definition of adherence to protocol-specified data collection for weekly ePRO, and 57.2% (159/278) did so for daily ePRO. For smartwatch data, 81.7% (227/278) of the participants adhered to the protocol-specified data collection. In total, 52.9% (147/278) of the participants met composite adherence. Compared with other digital health rheumatoid arthritis studies, a short run-in period appears useful for identifying participants likely to engage in a study that collects data via a mobile app and wearables and gives participants time to acclimate to study requirements. Automated or manual prompts (ie, "It's time to sync your smartwatch") may be necessary to optimize adherence. Adherence varies by data collection type (eg, ePRO vs smartwatch data). RR2-10.2196/14665.

Experiences and Priorities in Youth and Family Mental Health: Protocol for an Arts-Based Priority-Setting Focus Group Study.

During the COVID-19 pandemic, eHealth services enabled providers to reach families despite widespread social distancing restrictions. However, their rapid adoption often occurred without community partners' involvement and without an understanding of how they prioritize aspects of their mental health and associated service provision, both of which promote family and community-centered health care delivery. Establishing priorities in health care is essential for developing meaningful and reliable health services. As such, there is an urgent need to understand how eHealth service users, especially families who may have historically faced oppression and systemic barriers to service access, can best benefit from them. Arts-based approaches can elicit an understanding of priorities by providing an engaging and expressive means of moving beyond readily expressible discursive language and stimulating meaningful dialogue reflective of participants' lived experiences. The purpose of this research is to determine the priorities and preferences of youth; parents or caregivers; newcomers and immigrants; and Indigenous community members regarding the use of eHealth in supporting their mental health using an innovative arts-based priority-setting method. This study uses a mixed-methods approach combining qualitative, quantitative, and arts-based research. It follows a survey used to identify key knowledge partners who are interested in improving eHealth services for mental health support in Manitoba, Canada. Knowledge partners interested in group-based priority setting will be contacted to participate. We will facilitate approximately two focus groups across each subgroup of youth, parents or caregivers, newcomers or immigrants, and Indigenous community members using an integrative, quantitatively anchored arts-based method termed the "Circle of Importance" to understand participants' mental health priorities and how eHealth or technology may support their mental well-being. The Circle of Importance involves placing small objects, whose meaning is determined by participants, on a visual board with concentric circles that correspond to a 5-point Likert scale of importance. Following each focus group, we will evaluate participants' and focus group facilitators' experiences of the Circle of Importance using a survey and follow-up structured in-person interviews to garner how we can improve the arts-based approach used in the focus groups. The PRIME (Partnering for Research Innovation in Mental Health through eHealth Excellence) theme received institutional ethics approval on August 23, 2023. Data collection is projected for August 2023, with follow-up focus groups occurring in early 2024 as required. Data analysis will occur immediately following data collection. Findings will directly inform a multiyear applied research agenda for PRIME aimed at improving mental health services through engaging key knowledge partners. The results may inform how arts-based methods in a priority setting can reflect aspects of experience beyond the capacities of qualitative or quantitative methods alone, and whether this approach aligns well with a positive experience of research participation. PRR1-10.2196/50208.

Supporting Clinical Competencies in Men's Mental Health Using the Men in Mind Practitioner Training Program: User Experience Study.

Engaging men in psychotherapy is essential in male suicide prevention efforts, yet to date, efforts to upskill mental health practitioners in delivering gender-sensitized therapy for men have been lacking. To address this, we developed Men in Mind, an e-learning training program designed to upskill mental health practitioners in engaging men in therapy. This study involves an in-depth analysis of the user experience of the Men in Mind intervention, assessed as part of a randomized controlled trial of the efficacy of the intervention. Following completion of the intervention, participants provided qualitative (n=392) and quantitative (n=395) user experience feedback, focused on successes and suggested improvements to the intervention and improvements to their confidence in delivering therapy with specific subpopulations of male clients. We also assessed practitioner learning goals (n=242) and explored the extent to which participants had achieved these goals at follow-up. Participants valued the inclusion of video demonstrations of skills in action alongside the range of evidence-based content dedicated to improving their insight into the engagement of men in therapy. Suggested improvements most commonly reflected the desire for more or more diverse content, alongside the necessary adaptations to improve the learning and user experience. Participants also commonly reported improved confidence in assisting men with difficulty articulating their emotions in therapy and suicidal men. The evidence obtained from this study aids in plans to scale Men in Mind and informs the future development of practitioner training interventions in men's mental health. RR2-10.1186/s40359-022-00875-9.

Development of an Information Guideline for Kidney Transplant Recipients in a Clinical Trial: Protocol for a Modified Delphi Method.

Renal transplantation is the treatment of choice for most cases of end-stage renal disease. Recipients need to lead a healthy lifestyle to minimize the potential side effects of immunosuppressive drugs and improve transplant outcomes. There is not much evidence about the best way to increase adherence to healthy lifestyles in kidney transplant recipients, so one of the objectives set by the nursing team is to train people to acquire the necessary skills and tools to be able to take care of themselves. In this sense, the consensual development of appropriate materials may be useful and of interest. The aim of this study was to develop an information guide for adults with kidney transplants to be assessed in a subsequent clinical trial as an intervention to increase adherence to healthy habits. We used a 3-step, methodological, sequential approach: (1) training from a group of experts and item consensus; (2) review of the medical literature available; and (3) use of the Delphi technique with on-site meetings. A total of 5 nurses from the Community of Madrid Kidney Transplantation Unit in Spain were asked to participate. The patients' lifestyle factors that, according to the medical literature available and experts' opinions, have the greatest impact on the survival of the transplanted organ and the recipients themselves were all described. After using the modified Delphi method to reach a consensus on the items to be included and the information needed in each, an information guide for adult kidney transplant patients was developed. This guide facilitates the structuring of health care, information, and recommendations necessary for effective self-care for each person. The result is considered to be an easy-to-understand tool, useful for transplant doctors and nurses, in simple language, with information based on the latest scientific-medical evidence published to date, aspects of which will be evaluated in a clinical trial designed for this purpose. Currently, this guide is the main intervention variable of a clinical trial (registered on ClinicalTrials.gov; NCT05715580) aimed at improving compliance with healthy habits in kidney transplant recipients in the Community of Madrid, Spain. The method used in its development has been useful and agile, and the result is a guide that can be easily updated periodically following the same procedure. DERR1-10.2196/46961.

Developing Health Management Competency for Digital Health Transformation: Protocol for a Qualitative Study

Background Globally, the health care system is experiencing a period of rapid and radical change. In response, innovative service models have been adopted for the delivery of high-quality care that require a health workforce with skills to support transformation and new ways of working. Objective The aim of this research protocol is to describe research that will contribute to developing the capability of health service managers in the digital health era and enabling digital transformation within the Australian health care environment. It also explains the process of preparing and finalizing the research design and methodologies by seeking answers to the following three research questions: (1) To what extent can the existing health service management and digital health competency frameworks guide the development of competence for health service managers in understanding and managing in the digital health space? (2) What are the competencies that are necessary for health service managers to acquire in order to effectively work with and manage in the digital health context? (3) What are the key factors that enable and inhibit health service managers to develop and demonstrate digital health competence in the workplace? Methods The study has adopted a qualitative approach, guided by the empirically validated management competency identification process, using four steps: (1) health management and digital health competency mapping, (2) scoping review of literature and policy analysis, (3) focus group discussions with health service managers, and (4) semistructured interviews with digital health leaders. The first 2 steps were to confirm the need for updating the current health service management curriculum to address changing competency requirements of health service managers in the digital health context. Results Two initial steps have been completed confirming the significance of the study and study design. Step 1, competency mapping, found that nearly half of the digital competencies were only partially or not addressed at all by the health management competency framework. The scoping review articulated the competencies health service managers need to effectively demonstrate digital health competence in the workplace. The findings effectively support the importance of the current research and also the appropriateness of the proposed steps 3 and 4 in answering the research questions and achieving the research aim. Conclusions This study will provide insights into the health service management workforce performance and development needs for digital health and inform credentialing and professional development requirements. This will guide health service managers in leading and managing the adoption and implementation of digital health as a contemporary tool for health care delivery. The study will develop an in-depth understanding of Australian health service managers’ experiences and views. This research process could be applied in other contexts, noting that the results need contextualization to individual country jurisdictions and environments. International Registered Report Identifier (IRRID) DERR1-10.2196/51884

Cultural Adaptation of the Actionable Health App Evaluation in Japan: Protocol for a Web-Based Modified Delphi Expert Consensus Study

Background With an increase in both the number of mental health disorders people are experiencing and the difficulty in accessing mental health care, the demand for accessible mental health care services has increased. The use of mobile devices has allowed people to receive care in their daily lives without restrictions on time or location. However, the majority of publicly available mobile health apps are not evidence-based, and the top-rated apps are not always safe or user-friendly and may not offer clinically beneficial results. Objective This study aims to create a cultural adaptation of the American Psychiatric Association’s comprehensive app evaluation framework in Japan using a web-based modified Delphi expert consensus. Methods A web-based modified Delphi study includes developing the Japanese version of the comprehensive app evaluation framework and 3 Delphi rounds. In the first round, our working group sends a questionnaire to the panelists, who then complete it. In the second and third rounds, the working group sends a questionnaire and a summary of the panelists’ answers based on each of the previous rounds. The panelists answer the questionnaires based on this summary. The summarization procedure is automated to help reduce the biases that can be generated when panelists’ answers are summarized and when the panelists receive them. The working group sends only the result of the summarization with the next round’s questionnaire. All interactions between the working group and the panelists will be conducted on Qualtrics (Qualtrics Japan LLC), a questionnaire platform. To culturally validate the comprehensive mental health app evaluation framework, participants from the following three categories will be recruited in Japan: (1) researchers, (2) practitioners, and (3) app developers. Results This study received funding from a crowdfunding campaign in Japan (April 2023). The Delphi study began in January 2023 and will be completed in December 2023. We had already completed the translation of the 105 original app evaluation item questions by December 2022. Conclusions While the need for treatment using mental health apps is increasing, no framework that can be used to develop a centralized database for health apps is available or accessible, and no consensus has been reached among stakeholders in Japan about an appropriate framework. The results of the web-based modified Delphi method presented in this paper may provide direction for the development and use of mental health apps in the future among the relevant stakeholders. Furthermore, this study will enhance recognition of the framework among researchers, clinicians, mental health app developers, and users, in addition to devising new instruments to help users or practitioners efficiently choose the right app for their situations. International Registered Report Identifier (IRRID) PRR1-10.2196/44469

Comparing Oral Versus Intravenous Antibiotics Administration for Cellulitis Infection: Protocol for a Systematic Review and Meta-Analysis

Background Cellulitis is defined as an infection of the skin that is usually characterized by localized but poorly demarcated areas of erythema, swelling, and pain. Erysipelas is a subtype of cellulitis that is characterized by a more superficial infection, often involving the face. Because gram-positive bacteria are the most common infective agent, beta-lactam antibiotics such as cephalosporins are commonly used. However, guidelines and physician preference vary widely as different antibiotic options and routes of administration exist, in addition to the fact that most cases are treated empirically without microbiological lab guidance. This lack of standardization in evidence, guidelines, and physician practice prompted this systematic review and meta-analysis of both randomized trial data and cohort studies to aggregate the currently available evidence for the optimal routes of antibiotic administration in cellulitis treatment. Objective The primary objective of our review is to compare the efficacy of oral versus intravenous antibiotic administration for cellulitis infections, thereby providing clinicians with evidence-based guidelines for treatment. Methods We will search MEDLINE, Embase, and CENTRAL through Ovid as well as Web of Science and CINAHL for all available literature comparing different routes of antibiotic administration in the treatment of cellulitis and erysipelas. We will perform title and abstract as well as full-text screening in duplicate according to the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analyses) guidelines and then extract the relevant data using a prepiloted data sheet. The primary outcome for our review is the duration of infection resolution, and secondary outcomes such as incidence of sepsis, mortality, hospital admission, and Clostridium difficile infection. We will assess the risk of bias in our included studies using the RoB 2.0 (revised tool for Risk of Bias in randomized trials) and ROBINS-I (Risk of bias in non-randomized studies for interventions) tools, with a final quality assessment using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) framework and a sensitivity analysis to examine heterogeneity. Results We will publish the final results of our systematic review in a peer-reviewed academic journal. This project received no funding or financial assistance. Data analysis is currently underway, and the results are expected to be submitted for publication in late November 2023. Conclusions To our knowledge, this will be the most up-to-date review of the best available evidence comparing different routes of antibiotic administration for cellulitis. Because of the vast selection of antibiotic options available and the empirical nature of the treatment, we anticipate heterogeneity within our data but nonetheless hope to provide aggregated evidence on the efficacy of intravenous versus oral administration of antibiotics in cellulitis treatment. We hope the results from this study will better inform physician practices in the future for cellulitis infections. International Registered Report Identifier (IRRID) PRR1-10.2196/48342

A Silver Fluoride Intervention to Improve Oral Health Trajectories of Young Indigenous Australians: Protocol for a Cluster Randomized Controlled Trial

Background Indigenous Australian children and adolescents experience profound levels of preventable dental disease. The application of silver fluoride (AgF) to active dental caries is a noninvasive alternative to traditional dental treatment approaches. There is particular utility among Indigenous children and young people with dental fear, who may not have access to timely or culturally safe dental service provisions. Objective The aims of this study are to: (1) assess levels of active dental caries among Indigenous children and young people in 6 Australian states and territories; (2) determine if an AgF intervention reduces levels of active disease over 12-24 months; (3) measure the impact of improved oral health on social and emotional well-being (SEWB) and oral health-related quality of life; and (4) calculate the cost-effectiveness of implementing such an initiative. Methods The study will use a 2-arm, parallel cluster randomized controlled trial design. Approximately 1140 Indigenous children and youth aged between 2 and 18 years will be recruited. Each state or territory will have 2 clusters. The intervention group will receive the AgF intervention at the start of the study, with the delayed intervention group receiving the AgF intervention 12 months after study commencement. The primary outcome will be the arrest of active carious lesions, with arrested caries defined as nonpenetration by a dental probe. Secondary outcomes will include SEWB, oral health-related quality of life, and dental anxiety, with covariates including dental behaviors (brushing and dental visits). Effectiveness measures for the economic evaluation will include the number of children and young people managed in primary oral health care without the need for specialist referral, changes in SEWB, the numbers and types of treatments provided, and caries increments. Results Participant recruitment will commence in May 2023. The first results are expected to be submitted for publication 1 year after a 24-month follow-up. Conclusions Our findings have the potential to change the way in which active dental disease among Indigenous children and young people can be managed through the inclusion of specifically tailored AgF applications to improve dental health and SEWB delivered by Indigenous health care workers. Desired impacts include cost savings on expensive dental treatments; improved SEWB, nutrition, social, and learning outcomes; and improved quality of life for both children and young people and their caregivers and the broader Indigenous community. The AgF application could be easily implemented into the training program of Indigenous health workers and yield critical information in the management armamentarium of health and well-being recommendations for Australia’s First Peoples. International Registered Report Identifier (IRRID) PRR1-10.2196/48558

Effectiveness of Interventions to Improve Digital Health Literacy in Forced Migrant Populations: Protocol for a Mixed Methods Systematic Review

Background Digital health literacy is considered a health determinant that can influence improved health and well-being, health equity, and the reduction of social health inequalities. Therefore, it serves as an asset for individuals to promote their health. However, low digital health literacy is a major problem among forced migrant populations. They do not always have the capacity and skills to access digital health resources and use them appropriately. To our knowledge, no studies are currently available to examine effective interventions for improving digital health literacy among forced migrant populations. Objective This paper presents the protocol for a systematic review that aims to assess the effectiveness of digital health literacy interventions among forced migrant populations. With this review, our objectives are as follows: (1) identify interventions designed to improve digital health literacy among forced migrant populations, including interventions aimed at creating enabling conditions or environments that cater to the needs and expectations of forced migrants limited by low levels of digital health literacy, with the goal of facilitating their access to and use of eHealth resources; (2) define the categories and describe the characteristics of these interventions, which are designed to enhance the abilities of forced migrants or adapt digital health services to meet the needs and expectations of forced migrant populations. Methods A mixed methods systematic review will be conducted according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) checklist. The research will be conducted in an iterative process among the different authors. With the help of a medical information specialist, a specific search strategy will be formulated for the 6 most relevant databases (ie, MEDLINE, Embase, CINAHL, Web of Science, Academic Search Premier, PsycINFO, and the Google Scholar search engine). A literature search covering studies published between 2000 and 2022 has already been conducted. Two reviewers then proceeded, individually and independently, to conduct a double selection of titles, abstracts, and then full texts. Data extraction will be conducted by a reviewer and validated by a senior researcher. We will use the narrative synthesis method (ie, structured narrative summaries of key themes) to present a comprehensive picture of effective digital health literacy interventions among forced migrant populations and the success factors of these interventions. Results The search strategy and literature search were completed in December 2022. A total of 1232 articles were identified. The first selection was completed in July 2023. The second selection is still in progress. The publication of the systematic review is scheduled for December 2023. Conclusions This mixed methods systematic review will provide comprehensive knowledge on effective interventions for digital literacy among forced migrant populations. The evidence generated will further inform stakeholders and aid decision makers in promoting equitable access to and use of digital health resources for forced migrant populations and the general population in host countries. International Registered Report Identifier (IRRID) DERR1-10.2196/50798

Role of Individual Clinician Authority in the Implementation of Informatics Tools for Population-Based Medication Management: Qualitative Semistructured Interview Study.

Direct oral anticoagulant (DOAC) medications are frequently associated with inappropriate prescribing and adverse events. To improve the safe use of DOACs, health systems are implementing population health tools within their electronic health record (EHR). While EHR informatics tools can help increase awareness of inappropriate prescribing of medications, a lack of empowerment (or insufficient empowerment) of nonphysicians to implement change is a key barrier. This study examined how the individual authority of clinical pharmacists and anticoagulation nurses is impacted by and changes the implementation success of an EHR DOAC Dashboard for safe DOAC medication prescribing. We conducted semistructured interviews with pharmacists and nurses following the implementation of the EHR DOAC Dashboard at 3 clinical sites. Interview transcripts were coded according to the key determinants of implementation success. The intersections between individual clinician authority and other determinants were examined to identify themes. A high level of individual clinician authority was associated with high levels of key facilitators for effective use of the DOAC Dashboard (communication, staffing and work schedule, job satisfaction, and EHR integration). Conversely, a lack of individual authority was often associated with key barriers to effective DOAC Dashboard use. Positive individual authority was sometimes present with a negative example of another determinant, but no evidence was found of individual authority co-occurring with a positive instance of another determinant. Increased individual clinician authority is a necessary antecedent to the effective implementation of an EHR DOAC Population Management Dashboard and positively affects other aspects of implementation. RR2-10.1186/s13012-020-01044-5.

Respiratory health effects of e-cigarette substitution for tobacco cigarettes: a systematic review

BackgroundE-cigarettes (electronic nicotine delivery system, ENDS) have been presented as a harm reduction strategy for people who smoke tobacco cigarettes but who cannot achieve abstinence, or for those who wish to continue to enjoy nicotine and the habit of smoking. What are the health effects of the substitution of ENDS for tobacco cigarettes? This systematic review evaluates the evidence of human clinical tests on the respiratory effects of ENDS use in participants who smoke tobacco cigarettes.MethodsA registered and published protocol was developed conforming to PRISMA 2020 and AMSTAR2 standards. The literature search was conducted in PubMed, Scopus, and the CENTRAL Cochrane Library and updated to May 2022. Three supplementary searches and a grey literature search were performed. Studies were evaluated with the JBI quality tools and the Oxford Catalogue of Bias. Due to the heterogeneity (diversity) of the studies, a narrative data synthesis was performed on the test findings plus three sub-group analyses.ResultsThe review consists of sixteen studies and twenty publications. Spirometry tests comprised the majority of the data. In total, 66 respiratory test measurements were reported, out of which 43 (65%) were not significant. Statistically significant findings were mixed, with 9 tests showing improvements and 14 measuring declines, none of which was clinically relevant. Ten studies were rated at a high risk of bias, and six had some concerns primarily due to inadequate research designs and the conduct of the studies. Reporting bias was documented in thirteen studies.ConclusionsMost of the studies showed no difference in respiratory parameters. This indicates that ENDS substitution for smoking likely does not result in additional harm to respiratory health. Due to the low quality of the studies, confidence in the conclusions is rated as low. Robust studies with a longer duration and sufficient power are required to validate any potential benefits or possible harms of ENDS substitution.Registration PROSPERO #CRD42021239094, International Registered Report Identifier (IRRID): DERR1-10.2196/29084.