Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): summary of findings and assessment of existing guidelines.

BACKGROUND: The SAVVY project aims to improve the analyses of adverse events (AEs) in clinical trials through the use of survival techniques appropriately dealing with varying follow-up times and competing events (CEs). This paper summarizes key features and conclusions from the various SAVVY papers. METHODS: Summarizing several papers reporting theoretical investigations using simulations and an empirical study including randomized clinical trials from several sponsor organizations, biases from ignoring varying follow-up times or CEs are investigated. The bias of commonly used estimators of the absolute (incidence proportion and one minus Kaplan-Meier) and relative (risk and hazard ratio) AE risk is quantified. Furthermore, we provide a cursory assessment of how pertinent guidelines for the analysis of safety data deal with the features of varying follow-up time and CEs. RESULTS: SAVVY finds that for both, avoiding bias and categorization of evidence with respect to treatment effect on AE risk into categories, the choice of the estimator is key and more important than features of the underlying data such as percentage of censoring, CEs, amount of follow-up, or value of the gold-standard. CONCLUSIONS: The choice of the estimator of the cumulative AE probability and the definition of CEs are crucial. Whenever varying follow-up times and/or CEs are present in the assessment of AEs, SAVVY recommends using the Aalen-Johansen estimator (AJE) with an appropriate definition of CEs to quantify AE risk. There is an urgent need to improve pertinent clinical trial reporting guidelines for reporting AEs so that incidence proportions or one minus Kaplan-Meier estimators are finally replaced by the AJE with appropriate definition of CEs.

How does communication affect patient safety? Protocol for a systematic review and logic model.

INTRODUCTION: One in 10 patients are harmed in healthcare, more than three million deaths occur annually worldwide due to patient safety incidents, and the economic burden of patient safety incidents accounts for 15% of hospital expenditure. Poor communication between patients and practitioners is a significant contributor to patient safety incidents. This study aims to evaluate the extent to which patient safety is affected by communication and to provide a logic model that illustrates how communication impacts patient safety. METHODS AND ANALYSIS: We will conduct a systematic review of randomised and non-randomised studies, reported in any language, that quantify the effects of practitioner and patient communication on patient safety. We will search MEDLINE, CINAHL, APA PsychINfo, CENTRAL, Scopus and ProQuest theses and dissertations from 2013 to 7 February 2024. We will also hand-search references of included studies. Screening, data extraction and risk of bias assessment will be conducted by two independent reviewers. Risk of bias will be assessed using the Cochrane Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) for non-randomised studies, and the Cochrane Risk of Bias V.2 (RoB2) for randomised controlled trials. If appropriate, results will be pooled with summary estimates and 95% confidence intervals (CIs); otherwise, we will conduct a narrative synthesis. We will organise our findings by healthcare discipline, type of communication and type of patient safety incident. We will produce a logic model to illustrate how communication impacts patient safety. ETHICS AND DISSEMINATION: This systematic review does not require formal ethics approval. Findings will be disseminated through international conferences, news and peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42024507578.

Understanding patterns of fatigue in health and disease: protocol for an ecological momentary assessment study using digital technologies.

INTRODUCTION: Fatigue is prevalent across a wide range of medical conditions and can be debilitating and distressing. It is likely that fatigue is experienced differently according to the underlying aetiology, but this is poorly understood. Digital health technologies present a promising approach to give new insights into fatigue.The aim of this study is to use digital health technologies, real-time self-reports and qualitative interview data to investigate how fatigue is experienced over time in participants with myeloma, long COVID, heart failure and in controls without problematic fatigue. Objectives are to understand which sensed parameters add value to the characterisation of fatigue and to determine whether study processes are feasible, acceptable and scalable. METHODS AND ANALYSIS: An ecological momentary assessment study will be carried out over 2 or 4 weeks (participant defined). Individuals with fatigue relating to myeloma (n=10), heart failure (n=10), long COVID (n=10) and controls without problematic fatigue or a study condition (n=10) will be recruited. ECG patches will measure heart rate variability, respiratory rate, body temperature, activity and posture. A wearable bracelet accompanied by environment beacons will measure physical activity, sleep and room location within the home. Self-reports of mental and physical fatigue will be collected via smartphone app four times daily and on-demand. Validated fatigue and affect questionnaires will be completed at baseline and at 2 weeks. End-of-study interviews will investigate experiences of fatigue and study participation. A feedback session will be offered to participants to discuss their data.Data will be analysed using multilevel modelling and machine learning. Interviews and feedback sessions will be analysed using content or thematic analyses. ETHICS AND DISSEMINATION: This study was approved by the East of England-Cambridge East Research Ethics Committee (22/EE/0261). The results will be disseminated in peer-reviewed journals and at international conferences. TRIAL REGISTRATION NUMBER: NCT05622669.

Best Practices and Recommendations for Research Using Virtual Real-Time Data Collection: Protocol for Virtual Data Collection Studies.

BACKGROUND: The COVID-19 pandemic and the subsequent need for social distancing required the immediate pivoting of research modalities. Research that had previously been conducted in person had to pivot to remote data collection. Researchers had to develop data collection protocols that could be conducted remotely with limited or no evidence to guide the process. Therefore, the use of web-based platforms to conduct real-time research visits surged despite the lack of evidence backing these novel approaches. OBJECTIVE: This paper aims to review the remote or virtual research protocols that have been used in the past 10 years, gather existing best practices, and propose recommendations for continuing to use virtual real-time methods when appropriate. METHODS: Articles (n=22) published from 2013 to June 2023 were reviewed and analyzed to understand how researchers conducted virtual research that implemented real-time protocols. "Real-time" was defined as data collection with a participant through a live medium where a participant and research staff could talk to each other back and forth in the moment. We excluded studies for the following reasons: (1) studies that collected participant or patient measures for the sole purpose of engaging in a clinical encounter; (2) studies that solely conducted qualitative interview data collection; (3) studies that conducted virtual data collection such as surveys or self-report measures that had no interaction with research staff; (4) studies that described research interventions but did not involve the collection of data through a web-based platform; (5) studies that were reviews or not original research; (6) studies that described research protocols and did not include actual data collection; and (7) studies that did not collect data in real time, focused on telehealth or telemedicine, and were exclusively intended for medical and not research purposes. RESULTS: Findings from studies conducted both before and during the COVID-19 pandemic suggest that many types of data can be collected virtually in real time. Results and best practice recommendations from the current protocol review will be used in the design and implementation of a substudy to provide more evidence for virtual real-time data collection over the next year. CONCLUSIONS: Our findings suggest that virtual real-time visits are doable across a range of participant populations and can answer a range of research questions. Recommended best practices for virtual real-time data collection include (1) providing adequate equipment for real-time data collection, (2) creating protocols and materials for research staff to facilitate or guide participants through data collection, (3) piloting data collection, (4) iteratively accepting feedback, and (5) providing instructions in multiple forms. The implementation of these best practices and recommendations for future research are further discussed in the paper. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53790.

Effectiveness of web-based intervention on reducing symptom burden, improving self-management capabilities and self-efficacy among prostate cancer survivors: a systematic review and meta-analysis protocol.

INTRODUCTION: Prostate cancer is the most common malignant disease within the male genitourinary system. Advances in cancer screening and treatment have significantly ameliorated the survival rates of patients with prostate cancer. Nonetheless, prostate cancer survivors report various degrees of cancer-related symptoms. These symptoms cause physiological and psychological suffering, leading to a deterioration of quality of life. Web-based interventions may facilitate the management of symptoms due to their flexibility, accessibility and convenience. However, the efficacy of web-based interventions in reducing symptom burden remains to be confirmed. Consequently, this systematic review and meta-analysis aims to comprehensively synthesise existing evidence, evaluate the effectiveness of web-based interventions in reducing symptom burden among patients and furnish a reference for clinical practice. METHODS AND ANALYSIS: This protocol strictly adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol guidelines. We will comprehensively search six databases (PubMed, Web of Science, Cochrane, Embase, CINAHL and PsycINFO) from their inception to March 2024 in order to identify clinical trials on the efficacy of web-based interventions for prostate cancer survivors. Two reviewers will independently conduct study selection, data extraction and quality assessment. The risk bias of included studies will be assessed using the Cochrane Risk of Bias Tool for randomised trials 2.0, and the strength of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) guideline. Meta-analysis will be performed using STATA V.16.0, and the effect size will be calculated using the standardised mean difference and its 95% CI. Heterogeneity will be assessed using Cochran's Q statics and inconsistency will be measured using the I2 statistics. Potential sources of bias will be evaluated. ETHICS AND DISSEMINATION: Ethics approval is not required for this review as no human participants will be involved. The results will be disseminated via a peer-reviewed journal or an academic conference. PROSPERO REGISTRATION NUMBER: CRD42023457718.

Accuracy of digital measurement for quantitative and qualitative indicators of wound healing and repair: a systematic review protocol.

INTRODUCTION: Chronic wound care remains a critical public health challenge in terms of prevalence, quality of life and healthcare costs on a global scale. Currently used methods to assess the size and content of wounds include direct contact techniques based on double-layer film, ruler measurements, digital photography and visual examination. Nowadays, despite these evaluations, close monitoring and tracking of these chronic wounds remain a great challenge. The use of telemonitoring through digital measurement tools may offer a potential means of improving healing management processes. Many studies have evaluated the size and content of the wound through digital devices such as mobile phones and computers. However, the clinical accuracy of these tools remains to be clarified. The objective of this systematic review is to assess and consolidate the current state-of-the-art digital devices for both quantitative (length, width, surface area, perimeter, volume and depth) and qualitative (granulation, fibrin, necrosis and slough) indicators of wound care. METHODS AND ANALYSIS: We will include studies using digital measurement methods from databases such as EBSCO, Cochrane Library, MEDLINE, Web of Science and EMBASE, limited to French and English publications until November 15, 2023. Following the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines, selection involves two independent reviewers conducting title and abstract screenings, study selections, data extractions and risk-of-bias assessments using QUADAS-2. Discrepancies will be resolved through discussion or a third reviewer. ETHICS AND DISSEMINATION: Primary data will not be collected in this study; thus, ethical approval will not be required. The study's findings will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42023396642.

Investigating the use of actor-network theory in healthcare: a protocol for a systematic review.

Healthcare systems are confronted with constant challenges and new crisis waves necessitating a transformation of current approaches to healthcare delivery. Transformation calls for integration, partnerships, interprofessional teamwork and collaboration between all healthcare stakeholders to create improved access and more personalised healthcare outcomes for patients. However, healthcare organisations are complex systems, comprising multiple stakeholders, and the existence of professional silos and functions which have varying degrees of interaction hampering the delivery of effective integrated healthcare. Research investigating the underpinning operations of how the various healthcare stakeholders integrate is lacking. To address this gap, the use of actor-network theory (ANT) can provide insight into underlying dynamics, interactions, interdependencies, governance processes and power dynamics of stakeholders in healthcare. ANT represents a suitable theoretical lens as it helps to appreciate the dynamics and underpinning behaviours of complex organisations and explains how networks are developed and how actors join networks and form associations. Our systematic review will identify and evaluate available evidence to understand the interplay between stakeholders and all associated entities that impact collaboration and integration in healthcare delivery. METHODS AND ANALYSIS: Using the Population-Intervention-Comparison-Outcome framework, the databases MEDLINE, CINAHL Complete, SCOPUS, PubMed, APA PsycINFO, Business Source Complete and Academic Search Complete will be searched using Boolean terms to identify peer-reviewed literature concerning ANT in healthcare. All relevant articles published between January 2013 and September 2023 will be eligible for inclusion. A thematic approach will be employed to appraise and analyse the extracted data to assess the various definitions of ANT and the use of ANT in healthcare settings, interactions and collaboration. ETHICS AND DISSEMINATION: Given that no primary data will be captured, ethical approval will not be required for this study. Findings will be shared and ultimately published through open access peer-reviewed journals and reports. PROSPERO REGISTRATION NUMBER: 455283.

Perioperative Management in Patients with Atrial Fibrillation Treated with Non-Vitamin K Antagonist Oral Anticoagulants Undergoing Minor Bleeding Risk Procedure: Rationale and Protocol for the PERIXa Study.

Background: While treatment interruption of non-vitamin K antagonist oral anticoagulants (NOACs) for elective surgery or procedures among patients with atrial fibrillation (AF) is becoming more prevalent, there remains insufficient evidence regarding the optimal perioperative management of NOACs, particularly procedures with minor bleeding risks. Objective: This study aims to evaluate the safety and effectiveness of a simplified, standardized protocol for perioperative management of direct factor Xa inhibitors in patients, with AF undergoing procedures associated with minor bleeding risk. Methods: This multicenter, prospective single-arm registry study plans to enroll patients undergoing procedures with minor bleeding risk who were prescribed direct factor Xa inhibitors for AF. The procedures with minor bleeding risk will include gastrointestinal endoscopy for diagnostic purposes, selected dental procedures, and ocular surgery for cataracts or glaucoma. For apixaban, patients will withhold the last evening dose and resume either from the evening dose of the procedure day or the following morning, depending on the bleeding risk of the patient. For edoxaban or rivaroxaban, patients will withhold only a single dose on the procedure day. The primary outcome is the occurrence of major bleeding events within 30 days. Secondary outcomes include systemic thromboembolism, all-cause mortality, and a composite of major and clinically relevant non-major bleeding events. Conclusion: This study has the potential to generate evidence regarding the safety of perioperative management for patients, with AF undergoing procedures associated with minor bleeding risk. Trial Registration: Clinicaltrials.gov: NCT05801068.

Identifying meta-research with researchers as study subjects: Protocol for a scoping review.

BACKGROUND: Meta-research in which researchers are the study subjects can illuminate how to better support researchers and enhance the development of research capacity. Comprehensively compiling the literature in this area can help define best practices for research capacity development and reveal gaps in the literature. However, there are challenges to assessing and synthesizing the breadth of the meta-research literature produced. METHODS: In this article, we discuss the current barriers to conducting literature reviews on meta-research and strategies to address these barriers. We then outline proposed methods for conducting a scoping review on meta-research with researchers as study subjects. DISCUSSION: Due to its interdisciplinary nature, broad scope, and difficult to pinpoint terminology, little is known about the state of meta-research with researchers as the study subjects. For this reason, there is a need for a scoping review that will identify research performed in which researchers were the study subjects.

Evaluation of different landing pages on behavioural engagement with the CARA dashboard: A user research protocol.

BACKGROUND: CARA set out to develop a data-visualisation platform to facilitate general practitioners to develop a deeper understanding of their patient population, disease management and prescribing through dashboards. To support the continued use and sustainability of the CARA dashboards, dashboard performance and user engagement have to be optimised. User research places people at the centre of the design process and aims to evaluate the needs, behaviours and attitudes of users to inform the design, development and impact of a product. OBJECTIVE: To explore how different initial key messages impact the level of behavioural engagement with a CARA dashboard. METHODS: Participating general practices can upload their practice data for analysis and visualisation in CARA dashboards. Practices will be randomised to one of three different initial landing pages: the full dashboard or one of two key messages: a between comparison (their practice prescribing with the average of all other practices) or within comparison (with practice data of the same month the previous year) with subsequent continuation to the full dashboard. Analysis will determine which of the three landing pages encourages user interaction, as measured by the number of 'clicks', 'viewings' and 'sessions'. Dashboard usage data will be collected through Google analytics. DISCUSSION: This study will provide evidence of behavioural engagement and its metrics during the implementation of the CARA dashboards to optimise and sustain interaction. TRIAL REGISTRATION: ISRCTN32783644 (Registration date: 02/01/2024).

Identifying Existing Guidelines, Frameworks, Checklists, and Recommendations for Implementing Patient-Reported Outcome Measures: Protocol for a Scoping Review.

BACKGROUND: Implementing patient-reported outcome measures (PROMs) to measure and evaluate health outcomes is increasing worldwide. Along with this emerging trend, it is important to identify which guidelines, frameworks, checklists, and recommendations exist, and if and how they have been used in implementing PROMs, especially in clinical quality registries (CQRs). OBJECTIVE: This review aims to identify existing publications, as well as publications that discuss the application of actual guidelines, frameworks, checklists, and recommendations on PROMs' implementation for various purposes such as clinical trials, clinical practice, and CQRs. In addition, the identified publications will be used to guide the development of a new guideline for PROMs' implementation in CQRs, which is the aim of the broader project. METHODS: A literature search of the databases MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials will be conducted since the inception of the databases, in addition to using Google Scholar and gray literature to identify literature for the scoping review. Predefined inclusion and exclusion criteria will be used for all phases of screening. Existing publications of guidelines, frameworks, checklists, recommendations, and publications discussing the application of those methodologies for implementing PROMs in clinical trials, clinical practice, and CQRs will be included in the final review. Data relating to bibliographic information, aim, the purpose of PROMs use (clinical trial, practice, or registries), name of guideline, framework, checklist and recommendations, the rationale for development, and their purpose and implications will be extracted. Additionally, for publications of actual methodologies, aspects or domains of PROMs' implementation will be extracted. A narrative synthesis of included publications will be conducted. RESULTS: The electronic database searches were completed in March 2024. Title and abstract screening, full-text screening, and data extraction will be completed in May 2024. The review is expected to be completed by the end of August 2024. CONCLUSIONS: The findings of this scoping review will provide evidence on any existing methodologies and tools for PROMs' implementation in clinical trials, clinical practice, and CQRs. It is anticipated that the publications will help us guide the development of a new guideline for PROMs' implementation in CQRs. TRIAL REGISTRATION: PROSPERO CRD42022366085; https://tinyurl.com/bdesk98x. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52572.

Pragmaticism in Cancer Clinical Trials.

Clinical trials are essential for advancing oncology treatment strategies and have contributed significantly to the decline in cancer mortality rates over the past decades. Traditional explanatory trials, focused on establishing intervention efficacy in ideal settings, often lack generalizability and may not reflect real-world patient care scenarios. Furthermore, increasing complexity in cancer clinical trial design has led to challenges such as protocol deviations, slow enrollment leading to lengthened durations of trial, and escalating costs. By contrast, pragmatic trials aim to assess intervention effectiveness in more representative patient populations under routine clinical conditions. Here, we review the principles, methodologies, challenges, and advantages of incorporating pragmatic features (PFs) into cancer clinical trials. We illustrate the application of pragmatic trial designs in oncology and discuss the QUASAR collaborative, TAPUR study, and the ongoing PRAGMATICA-LUNG trial. Although not all oncology trials may be amenable to adopting fully pragmatic designs, integration of PFs when feasible will enhance trial generalizability and real-world applicability. Project Pragmatica and similar initiatives advocate for the integration of real-world practice with clinical trials, fostering a nuanced approach to oncology research that balances efficacy and effectiveness assessments, ultimately with a goal of improving patient outcomes.

Human-Centered Design and Benefit Realization Management in Digital Health Care Solution Development: Protocol for a Systematic Review.

BACKGROUND: Earlier research shows that a significant number of resources are wasted on software projects delivering less than the planned benefits. It has, however, been evidenced that adopting a human-centered design approach when designing health devices can be beneficial. This understanding from earlier research has raised our interest in investigating how human-centered design might contribute to realizing the potential benefits of health care software projects. To our current knowledge, this intersection of human-centered design and benefit realization management has not yet comprehensively and consistently been researched within the context of digital health care solutions. Therefore, there is a need for evidence synthesis using systematic reviews to address this potential research gap. OBJECTIVE: The objective of this study is to examine if human-centered design helps benefit realization management processes in the development of digital health care solutions and thereby enables better benefit realization. We explore the evidence of assumed or confirmed benefits of using human-centered design in the health care domain and whether better results have been reported when the benefit realization management process is followed. METHODS: This protocol was developed following the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) guidelines. The proposed review would use a planned and systematic approach to identify, evaluate, and synthesize relevant and recent studies (reported in English) to see if there is evidence that using human-centered design and benefit realization management has a positive effect on realizing set benefits in those projects. We will commence a systematic literature search using human-centered design, benefit realization management, and health care-related search terms within 5 repositories (ACM Digital Library, PubMed Central, Scopus, PubMed, and Web of Science). After removing duplicate results, a preliminary scan for titles and abstracts will be done by at least 2 reviewers. Any incongruities regarding whether to include articles for full-text review will be resolved by a third reviewer based on the predefined criteria. RESULTS: Initial queries of 2086 records have been executed and papers are being prescreened for inclusion. The search was initiated in December 2023 and the results are expected in 2024. We anticipate finding evidence of the use of human-centered design in the development of digital health care solutions. However, we expect evidence of benefitting from both human-centered design and benefit realization management in this context to be scarce. CONCLUSIONS: This protocol will guide the review of existing literature on the use of human-centered design and benefit realization management when developing digital health care solutions. The review will specifically focus on finding evidence of confirmed benefits derived from the use of human-centered design and benefit realization management. There may be an opportunity to gain a broader understanding of the tools or approaches that provide evidence of increased benefit realization within the health care domain. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56125.

Using Qualitative Questionnaires in Medical Education Research.

Most students in Health Profession Education courses are new to the world of qualitative research. Faced with the challenge of designing a research project, they are often drawn towards using the questionnaire as a data collection method, commonly assuming that utilising open-ended questions alone constitutes qualitative research design. Designing questionnaires that meet the standards of rigour is challenging, and this common assumption reflects inexperience with and misunderstandings of qualitative ontology, as well as the lack of methodological literature on designing and developing qualitative questionnaires. This paper is written with research supervisors as well as students in mind, as it is aimed to help elucidate the decision-making process and the justification for using a qualitative questionnaire. Drawing upon examples of research conducted by our students, and the wider literature, we demonstrate how qualitative questionnaires can produce rich and meaningful findings when they (1) prioritise qualitative research values, and (2) follow a rigorous design process when the questionnaire is developed. We conclude by offering a simple framework for developing rigorous qualitative questionnaires to those who may consider using this approach.

Application of Machine Learning in Multimorbidity Research: Protocol for a Scoping Review.

BACKGROUND: Multimorbidity, defined as the coexistence of multiple chronic conditions, poses significant challenges to health care systems on a global scale. It is associated with increased mortality, reduced quality of life, and increased health care costs. The burden of multimorbidity is expected to worsen if no effective intervention is taken. Machine learning has the potential to assist in addressing these challenges since it offers advanced analysis and decision-making capabilities, such as disease prediction, treatment development, and clinical strategies. OBJECTIVE: This paper represents the protocol of a scoping review that aims to identify and explore the current literature concerning the use of machine learning for patients with multimorbidity. More precisely, the objective is to recognize various machine learning models, the patient groups involved, features considered, types of input data, the maturity of the machine learning algorithms, and the outcomes from these machine learning models. METHODS: The scoping review will be based on the guidelines of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews). Five databases (PubMed, Embase, IEEE, Web of Science, and Scopus) are chosen to conduct a literature search. Two reviewers will independently screen the titles, abstracts, and full texts of identified studies based on predefined eligibility criteria. Covidence (Veritas Health Innovation Ltd) will be used as a tool for managing and screening papers. Only studies that examine more than 1 chronic disease or individuals with a single chronic condition at risk of developing another will be included in the scoping review. Data from the included studies will be collected using Microsoft Excel (Microsoft Corp). The focus of the data extraction will be on bibliographical information, objectives, study populations, types of input data, types of algorithm, performance, maturity of the algorithms, and outcome. RESULTS: The screening process will be presented in a PRISMA-ScR flow diagram. The findings of the scoping review will be conveyed through a narrative synthesis. Additionally, data extracted from the studies will be presented in more comprehensive formats, such as charts or tables. The results will be presented in a forthcoming scoping review, which will be published in a peer-reviewed journal. CONCLUSIONS: To our knowledge, this may be the first scoping review to investigate the use of machine learning in multimorbidity research. The goal of the scoping review is to summarize the field of literature on machine learning in patients with multiple chronic conditions, highlight different approaches, and potentially discover research gaps. The results will offer insights for future research within this field, contributing to developments that can enhance patient outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53761.