International Registered Report Identifier Research Articles

Wearable Sensor and Mobile App–Based mHealth Approach for Investigating Substance Use and Related Factors in Daily Life: Protocol for an Ecological Momentary Assessment Study

Digital health technologies using mobile apps and wearable devices are a promising approach to the investigation of substance use in the real world and for the analysis of predictive factors or harms from substance use. Moreover, consecutive repeated data collection enables the development of predictive algorithms for substance use by machine learning methods. We developed a new self-monitoring mobile app to record daily substance use, triggers, and cravings. Additionally, a wearable activity tracker (Fitbit) was used to collect objective biological and behavioral data before, during, and after substance use. This study aims to describe a model using machine learning methods to determine substance use. This study is an ongoing observational study using a Fitbit and a self-monitoring app. Participants of this study were people with health risks due to alcohol or methamphetamine use. They were required to record their daily substance use and related factors on the self-monitoring app and to always wear a Fitbit for 8 weeks, which collected the following data: (1) heart rate per minute, (2) sleep duration per day, (3) sleep stages per day, (4) the number of steps per day, and (5) the amount of physical activity per day. Fitbit data will first be visualized for data analysis to confirm typical Fitbit data patterns for individual users. Next, machine learning and statistical analysis methods will be performed to create a detection model for substance use based on the combined Fitbit and self-monitoring data. The model will be tested based on 5-fold cross-validation, and further preprocessing and machine learning methods will be conducted based on the preliminary results. The usability and feasibility of this approach will also be evaluated. Enrollment for the trial began in September 2020, and the data collection finished in April 2021. In total, 13 people with methamphetamine use disorder and 36 with alcohol problems participated in this study. The severity of methamphetamine or alcohol use disorder assessed by the Drug Abuse Screening Test-10 or the Alcohol Use Disorders Identification Test-10 was moderate to severe. The anticipated results of this study include understanding the physiological and behavioral data before, during, and after alcohol or methamphetamine use and identifying individual patterns of behavior. Real-time data on daily life among people with substance use problems were collected in this study. This new approach to data collection might be helpful because of its high confidentiality and convenience. The findings of this study will provide data to support the development of interventions to reduce alcohol and methamphetamine use and associated negative consequences. DERR1-10.2196/44275.

Utilization of Research in Clinical Nursing and Midwifery Practice in Ghana: Protocol for a Mixed Methods Study.

The International Council of Nurses' 2021 code of ethics mandates nurses to provide evidence-informed care to patients. Globally, using research evidence has led to improvement in nursing and midwifery practice, according to the World Health Organization. A study in Ghana found that 25.3% (n=40) of nurses and midwives use research in clinical care. Research utilization (RU) increases therapeutic effectiveness, improves health outcomes, and enhances the personal and professional development of clinicians. However, it is uncertain the extent to which nurses and midwives are prepared, skilled, and supported to utilize research in clinical care in Ghana. This study aims to develop a conceptual framework that can facilitate RU among clinical nurses and midwives in Ghanaian health facilities. This will be a cross-sectional study with a concurrent mixed methods approach. It will be conducted in 6 hospitals and 4 nursing educational institutions in Kumasi, Ghana. The study has 4 objectives which will be executed in 3 phases. Phase 1 follows a quantitative approach to describe the knowledge, attitudes, and practices of clinical nurses and midwives on the use of research in their practice. Using a web-based survey, 400 nurses and midwives working in 6 health facilities will be recruited. Data analysis will be conducted using SPSS, with statistical significance set at .05. Qualitative methodology, using focus group discussions with clinical nurses and midwives, will be conducted to identify the factors influencing their RU. In phase 2, focus group discussions will be used to examine and describe how nurse educators in 4 nursing and midwifery educational institutions prepare nurses and midwives for RU during their education. Views of nurse managers on the RU in Ghanaian health care facilities will be explored in the second section of this phase through one-on-one interviews. Inductive thematic analysis will be used to analyze the qualitative data, and Lincoln and Guba's principles of trustworthiness will be applied. In phase 3, the stages of model development proposed by Chinn and Kramer; and Walker and Avant will be used to triangulate findings from all objectives and formulate a conceptual framework. Data collection started in December 2022. Publication of the results will begin in April 2023. RU in clinical practice has become an acceptable practice in nursing and midwifery. It is critical that nursing and midwifery professionals in sub-Saharan Africa shift their practice to embrace the global movement. This proposed conceptual framework will empower nurses and midwives to improve their practice of RU. DERR1-10.2196/45067.

Platform-Based Patient-Clinician Digital Health Interventions for Care Transitions: Protocol for a Scoping Review

With the increased adoption of technology, the use of digital health interventions in health care settings has increased. Patient-clinician digital health interventions have the potential to improve patient care, especially during important transitions between hospital and home. Digital health interventions can provide support to patients during these transitions, thereby leading to better patient outcomes. This scoping review aims to explore the available literature, specifically (1) to examine the impact of platform-based digital health interventions focused on care transitions on patient outcomes, and (2) to identify the barriers to and enablers for the uptake and implementation of these digital health interventions. This protocol was developed based on Arksey and O'Malley's, Levac and colleagues', and JBI scoping review methodologies, and it has been reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement for the Scoping Reviews) format. The search strategies were developed for 4 databases: MEDLINE, CINAHL, EMBASE, and the Cochrane Central Register of Controlled Trials by using key words such as "hospital to home transition" and "platform-based digital health." Studies involving patients 16 years or older that used a platform-based digital health intervention during their hospital to home transition will be included in this review. Two reviewers will independently screen articles for eligibility by using a 2-stage process (ie, title and abstract screening and full-text screening). We expect to refine the eligibility criteria during the title and abstract screening process as we anticipate retrieving a significant number of articles. In addition, we will also perform a targeted search of the grey literature, as well as data extraction. Data analysis will consist of a narrative and descriptive synthesis. The review is expected to identify research gaps that will inform the development of future patient-clinician digital health interventions. We have identified a total of 8333 articles. Screening began in September 2022, and data extraction is expected to commence in February 2023 and end by April 2023. Data analyses and final results will be submitted to a peer-reviewed journal in August 2023. We expect to find a wide variety of postcare interventions, some gaps in the quality of research evidence, as well as a lack of detailed information on digital health interventions. PRR1-10.2196/42056.

Identification of Patients With Elevated Urine Albumin-to-Creatinine Ratio Levels in a Type 2 Diabetes Mellitus Cohort Based on Data Submitted by Patients via a Smartphone App (SMART-Finder): Protocol for an Observational Study.

Despite effective treatment options, chronic kidney disease (CKD) has become a major cause of mortality worldwide due to the ever-increasing number of patients with type 2 diabetes mellitus (T2DM). Guideline-compliant, at least, annual screening of patients with T2DM is crucial to prevent renal disease progression. However, data on the prevalence of CKD in patients with T2DM and on screening frequency are limited. SMART-Finder is the first study to exclusively use data provided directly by patients via an adherence app to collect information on the prevalence of CKD, risk factors, disease management, and quality of life of patients with T2DM in Germany. The primary objective of this study is to determine the proportion of patients with T2DM and an elevated urine albumin-to-creatinine ratio (UACR; albumin-to-creatinine ratio stage A2 and A3) at baseline and after 12 (±3) months. Secondary objectives include the proportion of patients who remain in or switch to another albumin-to-creatinine ratio classification category after 12 months, information on quality of life, disease awareness, and adherence rates, as well as the proportion of patients without any UACR-screening data. Recruitment occurs via push notification among MyTherapy app users with T2DM. This is a single-arm, retrospective/prospective, observational, digital, patient-centered cohort study, with recruitment and data documentation via a health app. Required routine laboratory data are provided by treating physicians to their patients for data entry. The study population includes adult patients with T2DM documenting their data in the MyTherapy app using their own smartphone or tablet. Study participants are provided with a specifically developed electronic case report form containing questions on demographic and general data, quality of life, disease awareness, and laboratory values including estimated glomerular filtration rate, UACR, hemoglobin 1Ac, and blood pressure. Apart from demographic and general data, all data are collected at baseline and 12 months after the last UACR assessment. An automatically generated push notification reminds participants of the second data entry. The extracted and pseudonymized data are analyzed descriptively. The enrollment period for this study started in February 2023 and shall end after 12 months or after the enrollment of 5000 patients. An interim analysis is planned 3 months after the inclusion of the first patient and the final analysis after 12 months of follow-up. Overall, the study will contribute to minimizing the existing data gap on the prevalence of CKD in patients with T2DM in Germany, provide important insights into the current disease management of patients with T2DM in everyday clinical practice in Germany, and support guideline-based care for the participating patients. PRR1-10.2196/44996.

Management of Pain and Cachexia in Pancreatic Cancer: Protocol for Two Systematic Reviews, Network Meta-Analysis, Surveys, and Focus Groups

Approximately 75% of people with pancreatic cancer experience pain, and >50% of them have cachexia (weakness and wasting of the body). However, there is considerable uncertainty regarding the management of these distressing symptoms. Our primary objectives are to compare the relative benefits and harms of different interventions for pain in people with unresectable pancreatic cancer and for prevention and treatment of cachexia due to pancreatic cancer, through systematic reviews and network meta-analysis. Our secondary objectives are to develop an evidence-based clinical care pathway to manage pain and prevent and treat cachexia in people with pancreatic cancer through surveys and focus groups involving patients, carers, and health care professionals. We will perform 2 systematic reviews of the literature related to pain and cachexia in people with pancreatic cancer using searches from Cochrane Library, MEDLINE, Embase, Science Citation Index, and trial registries. Two researchers will independently screen for eligibility and identify randomized controlled trials (no language or publication status restriction), comparing interventions for pain or cachexia based on full-texts for articles shortlisted during screening. We will assess risk of bias in the trials using the Cochrane risk of bias tool (version 2.0) and obtain data related to baseline prognostic characteristics, potential effect modifiers and outcome data related to overall survival, health-related quality of life, treatment-related complications, and resource utilisation. We aim to conduct network meta-analysis on outcomes with multiple treatment comparisons where possible, otherwise, meta-analysis with direct comparisons, or narrative synthesis. We will perform various subgroup and sensitivity analyses. Using information obtained from both systematic reviews, we will conduct 2 surveys: one directed to patients or carers to assess acceptability of interventions, and the other to health care professionals to assess feasibility of delivery in the National Health Service. Four mixed focus groups will be conducted to evaluate findings and foster consensus in the development of the care pathway. Funding was awarded from April 2022 (NIHR202727). Both systematic review protocols were prospectively registered on PROSPERO in May 2022. Formal searches began thereafter. Approval by the University College London Research Ethics Committee (23563/001) was received in December 2022. Data collection began in January 2023; data analysis will begin in May 2023 (completion expected by October 2023). This study will comprehensively encompass major interventions for management of pain in people with unresectable pancreatic cancer, and prevention and treatment of cachexia in people with pancreatic cancer. Key stakeholders will facilitate the development of an evidence-based care pathway, ensuring both acceptability and feasibility. The project ends in April 2024 and published results are expected within 12 months of completion. We aim to present the findings through patient group websites, conferences, and publications, irrespective of the findings, in a peer-reviewed journal. DERR1-10.2196/46335.

Value of Including the Children’s Experience for Improving Their Rights During Hospitalization: Protocol for the VoiCEs Project

Users' feedback is a key asset for organizations that want to improve their services. Studying how organizations are enabling their users to participate in evaluation activities is particularly important, especially when there are vulnerable or disadvantaged people, and the services to be evaluated can be life-changing. This is the case in the coassessment by pediatric patients experiencing hospital stay. The international literature reports a few attempts and several challenges in systematically collecting and using the pediatric patient experience with respect to hospitalization, to undertake quality improvement actions. This paper describes the research protocol of a European project intended to develop and implement a systematic pediatric patient-reported experience measures (PREMs) observatory that will be shared by 4 European children's hospitals in Finland, Italy, Latvia, and the Netherlands. The VoiCEs (Value of including the Children's Experience for improving their rightS during hospitalization) project uses a participatory action research approach, based on a mixture of qualitative and quantitative methods. It consists of 6 different phases, including a literature review, an analysis of the previous experiences of pediatric PREMs reported by project partners, a Delphi process, a cycle of focus groups or in-depth interviews with children and their caregivers, a series of workshops with interactive working groups, and a cross-sectional observational survey. The project guarantees the direct participation of children and adolescents in the development and implementation phases of the project. The expected results are (1) a deeper knowledge of published methodologies and tools on collecting and reporting pediatric patients' voice; (2) lessons learnt from the analysis of previous experiences of pediatric PREMs; a consensus reached through a participatory process (3) among experts, (4) pediatric patients and caregivers about a standard set of measures for the evaluation of hospitalization by patients; (5) the implementation of a European observatory on pediatric PREMs; and (6) the collection and comparative reporting of the pediatric patients' voice. In addition, the project is aimed at studying and proposing innovative methodologies and tools for capturing the pediatric patients' feedback directly, avoiding the intermediation of parents/guardians. Over the last decade, the collection and use of PREMs have gained importance as a research field. Children and adolescents' perspectives have also been increasingly taken into consideration. However, to date, there are limited experiences regarding the continuous and systematic collection and use of pediatric PREMs data for implementing timely improvement actions. In this perspective, the VoiCEs project provides room for innovation, by contributing to the creation of an international, continuous, and systematic pediatric PREMs observatory that can be joined by other children's hospitals or hospitals with pediatric patients, and foresees the return of usable and actionable data in benchmarking. DERR1-10.2196/42804.

Management of Hypertension Using a Plant-Based Diet Among Farmers: Protocol for a Mixed Methods Study

Farmers in Indonesia have a high risk for hypertension owing to their lifestyle and working environment. Diet management is a solution to reduce hypertension, and Indonesia has natural resources in the agricultural sector that could help manage hypertension. Optimizing vegetable and fruit intake in a plant-based diet (PBD) could help maintain blood pressure among farmers in Indonesia. This study aims to explore the health problem of hypertension and the characteristics of local food sources to formulate a PBD menu for treating hypertension, as well as assess the prevalence of hypertension, level of acceptability of a PBD, and associated sociodemographic factors. Further, we want to examine the effectiveness of a community-based nursing program for managing hypertension using a PBD. We will use the exploratory sequential mixed methods approach. There will be a qualitative study (phase I) in 2022 and a quantitative study (phase II) in 2023. We will analyze data using a thematic framework in phase I. In phase II, the study will involve (1) questionnaire development and validation; (2) examination of the prevalence of hypertension, the level of acceptability of a PBD, and the associated factors; and (3) a randomized controlled trial. We will recruit farmers with hypertension who meet the study criteria. Moreover, in phase II, we will invite expert nurses and nutritionists to assess the face and content validity of the questionnaire. We will use multiple logistic regression models to estimate the associated sociodemographic factors and the level of acceptability of a PBD. Furthermore, a linear generalized estimating equation will be used to estimate the parameters of a generalized linear model with a possible unmeasured correlation between observations from different time points for systolic and diastolic blood pressure. A model PBD for hypertension management is expected to be developed. In 2022, we will collect information on hypertension and the characteristics of local food sources for managing hypertension, and will formulate a PBD menu to treat hypertension among farmers. In 2023, we will develop a questionnaire to assess the acceptability of a PBD to manage hypertension among farmers, the prevalence of hypertension, and the sociodemographic factors associated with hypertension among farmers. We will implement a community-based nursing program for managing hypertension using a PBD among farmers. The PBD model will not be readily available for other agricultural areas since validation of local food variation is required to design the menu. We expect contributions from the local government to implement the intervention as one of the policies in the management of hypertension for farmers in the agricultural plantation areas of Jember. This program may also be implemented in other agricultural countries with similar problems, so that hypertension can be optimally treated among farmers. PRR1-10.2196/41146.

Development of a Conversational Agent for Individuals Ambivalent About Quitting Smoking: Protocol for a Proof-of-Concept Study

Cigarette smoking is the leading preventable cause of disease and death in the United States. Despite the availability of a plethora of evidence-based smoking cessation resources, less than one-third of individuals who smoke seek cessation services, and individuals using these services are often those who are actively contemplating quitting smoking. There is a distinct dearth of low-cost, scalable interventions to support smokers not ready to quit (ambivalent smokers). Such interventions can assist in gradually promoting smoking behavior changes in this target population until motivation to quit arises, at which time they can be navigated to existing evidence-based smoking cessation interventions. Conversational agents or chatbots could provide cessation education and support to ambivalent smokers to build motivation and navigate them to evidence-based resources when ready to quit. The goal of our study is to test the proof-of-concept of the development and preliminary feasibility and acceptability of a smoking cessation support chatbot. We will accomplish our study aims in 2 phases. In phase 1, we will survey 300 ambivalent smokers to determine their preferences and priorities for a smoking cessation support chatbot. A "forced-choice experiment" will be administered to understand participants' preferred characteristics (attributes) of the proposed chatbot prototype. The data gathered will be used to program the prototype. In phase 2, we will invite 25 individuals who smoke to use the developed prototype. For this phase, participants will receive an overview of the chatbot and be encouraged to use the chatbot and engage and interact with the programmed attributes and components for a 2-week period. At the end of phase 1, we anticipate identifying key attributes that ambivalent smokers prefer in a smoking cessation support chatbot. At the end of phase 2, chatbot acceptability and feasibility will be assessed. The study was funded in June 2022, and data collection for both phases of the study is currently ongoing. We expect study results to be published by December 2023. Study results will yield a smoking behavior change chatbot prototype developed for ambivalent smokers that will be ready for efficacy testing in a larger study. DERR1-10.2196/44041.

Digital Outcome Measurement to Improve Care for Patients With Immune-Mediated Inflammatory Diseases: Protocol for the IMID Registry

Despite enormous clinical improvements, due to better management strategies and the availability of biologicals, immune-mediated inflammatory diseases (IMIDs) still have a significant impact on patients' lives. To further reduce disease burden, provider- as well as patient-reported outcomes (PROs) should be taken into account during treatment and follow-up. Web-based collection of these outcomes generates valuable repeated measurements, which could be used (1) in daily clinical practice for patient-centered care, including shared decision-making; (2) for research purposes; and (3) as an essential step toward the implementation of value-based health care (VBHC). Our ultimate goal is that our health care delivery system is completely aligned with the principles of VBHC. For aforementioned reasons, we implemented the IMID registry. The IMID registry is a digital system for routine outcome measurement that mainly includes PROs to improve care for patients with IMIDs. The IMID registry is a longitudinal observational prospective cohort study within the departments of rheumatology, gastroenterology, dermatology, immunology, clinical pharmacy, and outpatient pharmacy of the Erasmus MC, the Netherlands. Patients with the following diseases are eligible for inclusion: inflammatory arthritis, inflammatory bowel disease, atopic dermatitis, psoriasis, uveitis, Behçet disease, sarcoidosis, and systemic vasculitis. Generic and disease-specific (patient-reported) outcomes, including adherence to medication, side effects, quality of life, work productivity, disease damage, and activity, are collected from patients and providers at fixed intervals before and during outpatient clinic visits. Data are collected and visualized through a data capture system, which is linked directly to the patients' electronic health record, which not only facilitates a more holistic care approach, but also helps with shared decision-making. The IMID registry is an ongoing cohort with no end date. Inclusion started in April 2018. From start until September 2022, a total of 1417 patients have been included from the participating departments. The mean age at inclusion was 46 (SD 16) years, and 56% of the patient population is female. The average percentage of filled out questionnaires at baseline is 84%, which drops to 72% after 1 year of follow-up. This decline may be due to the fact that the outcomes are not always discussed during the outpatient clinic visit or because the questionnaires were sometimes forgotten to set out. The registry is also used for research purposes and 92% of the patients with IMIDs gave informed consent to use their data for that. The IMID registry is a web-based digital system that collects provider- and PROs. The collected outcomes are used to improve care for the individual patient with an IMID and facilitate shared decision-making, and they are also used for research purposes. The measurement of these outcomes is an essential step toward the implementation of VBHC. DERR1-10.2196/43230.

Web-Based Patient Recommender Systems for Preventive Care: Protocol for Empirical Research Propositions

Preventive care helps patients identify and address medical issues early when they are easy to treat. The internet offers vast information about preventive measures, but the sheer volume of data can be overwhelming for individuals to process. To help individuals navigate this information, recommender systems filter and recommend relevant information to specific users. Despite their popularity in other fields, such as e-commerce, recommender systems have yet to be extensively studied as tools to support the implementation of prevention strategies in health care. This underexplored area presents an opportunity for recommender systems to serve as a complementary tool for medical professionals to enhance patient-centered decision-making and for patients to access health information. Thus, these systems can potentially improve the delivery of preventive care. This study proposes practical, evidence-based propositions. It aims to identify the key factors influencing patients' use of recommender systems and outlines a study design, methods for creating a survey, and techniques for conducting an analysis. This study proposes a 6-stage approach to examine user perceptions of the factors that may influence the use of recommender systems for preventive care. First, we formulate 6 research propositions that can be developed later into hypotheses for empirical testing. Second, we will create a survey instrument by collecting items from extant literature and then verify their relevance using expert analysis. This stage will continue with content and face validity testing to ensure the robustness of the selected items. Using Qualtrics (Qualtrics), the survey can be customized and prepared for deployment on Amazon Mechanical Turk. Third, we will obtain institutional review board approval because this is a human subject study. In the fourth stage, we propose using the survey to collect data from approximately 600 participants on Amazon Mechanical Turk and then using R to analyze the research model. This platform will serve as a recruitment tool and the method of obtaining informed consent. In our fifth stage, we will perform principal component analysis, Harman Single Factor test, exploratory factor analysis, and correlational analysis; examine the reliability and convergent validity of individual items; test if multicollinearity exists; and complete a confirmatory factor analysis. Data collection and analysis will begin after institutional review board approval is obtained. In pursuit of better health outcomes, low costs, and improved patient and provider experiences, the integration of recommender systems with health care services can extend the reach and scale of preventive care. Examining recommender systems for preventive care can be vital in achieving the quadruple aims by advancing the steps toward precision medicine and applying best practices. PRR1-10.2196/43316.

Health Care Professionals’ Experiences and Perspectives on Using Telehealth for Home-based Palliative Care: Scoping Review

Telehealth seems feasible for use in home-based palliative care (HBPC). It may improve access to health care professionals (HCPs) at patients' homes, reduce hospital admissions, enhance patients' feelings of security and safety, and increase the time spent at home for patients in HBPC. HBPC requires the involvement of various HCPs such as nurses, physicians, allied health professionals, dietitians, psychologists, religious counselors, and social workers. Acceptance of the use of technology among HCPs is essential for the successful delivery of telehealth in practice. No scoping review has mapped the experiences and perspectives of HCPs regarding the use of telehealth in HBPC. The aim of this review was to systematically map published studies on HCPs' experiences and perspectives on the use of telehealth in HBPC. A scoping review was conducted using the methodology of Arksey and O'Malley. The review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews. A systematic search was performed in AMED, CINAHL, Embase, MEDLINE, PsycINFO, and Web of Science for studies published in peer-reviewed journals between January 1, 2000, and August 23, 2022. The reference lists of the included papers were hand searched to identify additional studies. The inclusion criteria were (1) studies using qualitative, quantitative, or mixed methods; (2) studies including HCPs using telehealth with patients in HBPC; (3) studies on HCPs' experiences and perspectives on the use of telehealth in HBPC; (4) studies published between January 1, 2000, and August 23, 2022; and (5) studies published in English, Portuguese, Norwegian, Danish, Swedish, or Spanish. Pairs of authors independently included studies and extracted data. The first 2 stages of thematic synthesis were used to thematically organize the data. This scoping review included 29 papers from 28 studies. Four descriptive themes were identified: (1) easy to use but technological issues undermine confidence, (2) adds value but personal and organizational barriers challenge adoption, (3) potential to provide useful and meaningful patient-reported data, and (4) mutual trust as a prerequisite for interpersonal relationships. Telehealth in HBPC seems to be easy to use and may improve the coordination of care, time efficiency, clinical assessments, and help build and enhance personal and professional relationships. However, the introduction of technology in HBPC is complex, as it may not align well with the overall aim of palliative care from HCPs' point of view. Further, changes in practice and requirements for HCPs may reduce motivation for the use of telehealth in HBPC. HCPs consider themselves to have central roles in implementing telehealth, and a lack of acceptance and motivation is a key barrier to telehealth adoption. Policy makers and telehealth developers should be aware of this potential barrier when developing or implementing new technology for use in HBPC. RR2-10.2196/33305.

Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies.

Journal articles describing randomized controlled trials (RCTs) and systematic reviews with meta-analysis of RCTs are not optimally reported and often miss crucial details. This poor reporting makes assessing these studies' risk of bias or reproducing their results difficult. However, the reporting quality of diet- and nutrition-related RCTs and meta-analyses has not been explored. We aimed to assess the reporting completeness and identify the main reporting limitations of diet- and nutrition-related RCTs and meta-analyses of RCTs, estimate the frequency of reproducible research practices among these RCTs, and estimate the frequency of distorted presentation or spin among these meta-analyses. Two independent meta-research studies will be conducted using articles published in PubMed-indexed journals. The first will include a sample of diet- and nutrition-related RCTs; the second will include a sample of systematic reviews with meta-analysis of diet- and nutrition-related RCTs. A validated search strategy will be used to identify RCTs of nutritional interventions and an adapted strategy to identify meta-analyses in PubMed. We will search for RCTs and meta-analyses indexed in 1 calendar year and randomly select 100 RCTs (June 2021 to June 2022) and 100 meta-analyses (July 2021 to July 2022). Two reviewers will independently screen the titles and abstracts of records yielded by the searches, then read the full texts to confirm their eligibility. The general features of these published RCTs and meta-analyses will be extracted into a research electronic data capture database (REDCap; Vanderbilt University). The completeness of reporting of each RCT will be assessed using the items in the CONSORT (Consolidated Standards of Reporting Trials), its extensions, and the TIDieR (Template for Intervention Description and Replication) statements. Information about practices that promote research transparency and reproducibility, such as the publication of protocols and statistical analysis plans will be collected. There will be an assessment of the completeness of reporting of each meta-analysis using the items in the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement and collection of information about spin in the abstracts and full-texts. The results will be presented as descriptive statistics in diagrams or tables. These 2 meta-research studies are registered in the Open Science Framework. The literature search for the first meta-research retrieved 20,030 records and 2182 were potentially eligible. The literature search for the second meta-research retrieved 10,918 records and 850 were potentially eligible. Among them, random samples of 100 RCTs and 100 meta-analyses were selected for data extraction. Data extraction is currently in progress, and completion is expected by the beginning of 2023. Our meta-research studies will summarize the main limitation on reporting completeness of nutrition- or diet-related RCTs and meta-analyses and provide comprehensive information regarding the particularities in the reporting of intervention studies in the nutrition field. DERR1-10.2196/43537.

Digital Technologies for Health Promotion and Disease Prevention in Older People: Scoping Review.

Digital technologies have the potential to contribute to health promotion and disease prevention in the aging world. This study aims to identify digital technologies for health promotion and disease prevention that could be used independently by older people in nonclinical settings using a scoping review. Through database (MEDLINE, PsycINFO, CINAHL, and SCOPUS; to March 3, 2022) and manual searches (to June 14, 2022), 90 primary studies and 8 systematic reviews were included in this scoping review. The eligibility was based on the PCC (Population, Concept, and Context) criteria: (1) people aged 50 years or older (population), (2) any digital (health) technology (eg, smartphone apps, websites, virtual reality; concept), and (3) health promotion and disease prevention in daily life in nonclinical and noninstitutional settings (context). Data items included study characteristics, PCC criteria, opportunities versus challenges, and evidence gaps. Data were synthesized using descriptive statistics or narratively described by identifying common themes. The studies were published in 2005-2022 and originated predominantly from North America and Europe. Most primary studies were nonrandomized, reported quantitative data, and investigated effectiveness or feasibility (eg, acceptance or usability) of digital technologies in older people. The participants were aged 50 years to 99 years, predominantly female, affluent (ie, with high income, education, and digital competence), and intended to use or used digital technologies for a median of 3 months independently at home or in community settings. The digital technologies included mobile or nonmobile technologies or virtual reality. The studies used "modern devices" (eg, smartphones, wearables, or gaming consoles) or modern and "older devices" (eg, computers or mobile phones). The users interacted with digital technologies via websites, emails, text messages, apps, or virtual reality. Health targets of digital technologies were mobility, mental health, nutrition, or cognition. The opportunities versus challenges of digital technologies were (1) potential health benefits versus unclear or no benefits for some outcomes, (2) monitoring of health versus ethical issues with data collection and management, (3) implications for functioning in daily life (ie, potential to prolong independent living) versus unclear application for clinical management or care, (4) tailoring of technical properties and content toward older users versus general use, (5) importance of human support for feasibility versus other factors required to improve feasibility, (6) reduction of social isolation versus access to digital technologies, and (7) improvement in digital competence versus digital divide. Various digital technologies were independently used by people aged 50 years or older for health promotion and disease prevention. Future studies should focus on (1) more diverse populations of older people, (2) new digital technologies, (3) other (clinical and care) settings, and (4) outcome evaluation to identify factors that could enhance any health benefits of digital technologies. RR2-10.2196/37729.

Sexual Health Outcomes of Adolescent and Young Adult Colorectal Cancer Survivors and Their Partners: Protocol of a Dyadic Mixed Methods Study

Sexual dysfunction represents a critical aspect of quality of life for adolescent and young adult cancer survivors. Studies have consistently documented that adolescents and young adults report greater psychological and physical morbidity than older survivors and healthy peers, including elevated rates of sexual dysfunction, often accompanied by lower satisfaction with sex life and delays in meeting sexual milestones. Moreover, sexual dysfunction, body image concerns, and fertility status affect their confidence in being both physically and emotionally intimate. Despite this evidence, limited research has investigated the influence of psychosocial and interpersonal factors on sexual health outcomes reported by this group. This constitutes a significant gap in the provision of comprehensive sexual health care for adolescent- and young adult-onset cancer survivors, especially since greater emphasis has been recently placed on the biopsychosocial model of sexuality and dyadic approaches to intervention and treatment. In comparison to other cancer types, the incidence of colorectal cancer (CRC) has been increasing at an alarming rate for the adolescent and young adult group. Patients with early-onset CRC experience elevated rates of sexual dysfunction, psychological distress, and social and physical burden, often resulting from issues with bowel control, incontinence, and body image. This study uses an explanatory sequential mixed methods approach to (1) characterize sexual function, sexual distress, dyadic coping, infertility-related distress, relationship and mental health outcomes of adolescent and young adult CRC survivors within the first 5 years post diagnosis and their partners; (2) examine the reciprocal influence of sexual function and dyadic coping behaviors on sexual distress; and (3) identify interpersonal or couple characteristics associated with coping with sexual dysfunction and its associated distress. Participating couples (n=60) will complete a quantitative web-based survey investigating sexual function, sexual distress, dyadic coping, infertility-related distress, emotional functioning, relationship satisfaction, and body image (cancer survivors only). A subset of 20 couples will participate in an in-depth dyadic interview with 2 members of the research team to further explore couple-based strategies implemented to cope with cancer-related sexual dysfunction and distress. The study received institutional review board approval. Recruitment and enrollment of couples began in July 2022. Results will provide a deeper understanding of the challenges couples experience as they navigate sexual intimacy after CRC treatment by highlighting the role of interpersonal processes. These findings will inform a dyadic intervention for young couples at risk of greater sexual distress in the aftermath of CRC. DERR1-10.2196/41831.

Parents' and Health Care Professionals' Perspectives on Prevention and Prediction of Food Allergies in Children: Protocol for a Qualitative Study.

Food allergy in children is increasing in prevalence in the western world and appears to become an important health problem. Parents of children at risk of food allergy live with the fear of allergic reaction, especially when the children are very young. The paradigm shift in allergy prevention in the last decade-away from allergen avoidance toward a tolerance induction approach-challenges both parents and health care professionals, as they have to deal with changing information and new evidence that often contradicts previous assumptions. Yet, research on health information-seeking behavior and needs of parents on primary prevention of food allergy in children as well as on prediction and prevention strategies of German health care professionals is lacking. The aim of the study is to explore and understand parents' and health care professionals' perspectives on the prediction and prevention of food allergies. We are particularly interested in information needs, information seeking, and health care usage and place a special focus on families' experiences when their child is at risk or diagnosed with food allergies. Furthermore, food allergy prediction and prevention strategies of health care professionals will be explored. This study is part of the NAMIBIO (food allergy biomarker) app consortium, which aims to identify early predictors for the development of food allergy in children and develop apps to guide health care professionals and parents of children with a high risk of food allergy toward prevention and timely tolerance induction. The study uses a qualitative approach with topic-guided interviews and focus groups with parents of children (0-3 years) and health care professionals. Data collection will continue until theoretical saturation is reached. The qualitative content analysis will be used according to Kuckartz to identify overarching themes toward information needs and seeking behavior as well as usage of health care and health care professionals' predictive and preventive strategies. In addition, a constructivist grounded theory approach will be used to explore and understand parents' experiences, interactions, and social processes in families in daily life. Recruitment and data collection started in February 2022 and is still ongoing. The qualitative study will provide insight into parents' information-seeking behavior and needs regarding the prevention of food allergy in children, parents' use of pediatric primary care, and health care professionals strategies for the prediction and prevention of food allergies in children. We assume that our results will highlight the challenges associated with the paradigm shift in allergy prevention for both parents and health care professionals. The results will be used to make practical recommendations from the user's perspective and inform the development of the NAMIBIO apps. DERR1-10.2196/41436.

Real-time Assessment of the Bidirectional Relationship Between Affective States and Glucose: Protocol for a 14-Day Observational Study

Glucose variability increases cardiometabolic disease risk. While many factors can influence glucose levels, postprandial glucose response is the primary driver of glucose variability. Furthermore, affect may directly and indirectly impact glucose variability through its effect on eating behavior. Continuous glucose monitors (CGMs) facilitate the real-time evaluation of blood glucose, and ecological momentary assessment (EMA) can be used to assess affect in real time. Together, data collected from these sources provide the opportunity to further understand the role of affect in glucose levels. This paper presents the protocol for a study that aims to (1) evaluate the feasibility and acceptability of using CGMs along with EMA in nondiabetic populations and (2) examine the bidirectional relationship between affect and glucose in nondiabetic adults with overweight or obesity using a CGM and EMA. Eligibility criteria for the study include participants (1) aged 18 to 65 years old, (2) with a BMI of ≥25 kg/m2, (3) who are able to read and write in English, and (4) who own a smartphone. Individuals will be excluded if they (1) have type 1 or 2 diabetes or have any other condition that requires glucose monitoring, (2) are pregnant, (3) use any medications that have the potential to alter blood glucose levels or interfere with the glucose sensing process, or (4) have a diagnosed gastrointestinal condition or eating disorder. In a 14-day observational study, participants will wear a FreeStyle Libre Pro CGM sensor (Abbott) and will receive mobile phone-based EMA prompts 6 times per day (randomly within six 2-hour windows between 8 AM and 8 PM) to assess positive and negative affect. Participants will also wear a Fitbit Inspire 2 (Fitbit) to continuously monitor physical activity and sleep, which will be included as covariates in the analysis. Multilevel linear regression models will be used to evaluate the acute relationship between glucose level and affect. Recruitment started in October 2022 and is expected to be completed in March 2023. We will aim to recruit 100 participants. As of December 12, 2022, a total of 39 participants have been enrolled. The results of this study will further elucidate the role of affect in glucose variability. By identifying affective states that may lead to glucose excursions, our findings could inform just-in-time behavioral interventions by indicating opportunities for intervention delivery. DERR1-10.2196/45104.

Parent Experiences of Child Loss and End-of-Life Care in a Pediatric Intensive Care Unit: Protocol for a Qualitative Study.

Death of a child in the pediatric intensive care unit is a rare event that can occur after failed cardiopulmonary resuscitation efforts, after a brain death diagnosis, or after a decision to limit therapeutic efforts. Nevertheless, even in the case of children with terminal and progressive illnesses, death is a crisis that comes as a surprise to parents and is perceived as unexpected. In the final stage of a child's life, health care staff play a key role in sharing feelings and experiences with the family and in supporting them throughout the process in order to facilitate the grieving process. The aim of this study is to explore the experiences of parents whose children have died in a pediatric intensive care unit. To address the study aims, a qualitative phenomenological study based on the van Manen proposal will be carried out. The study will be conducted in the pediatric intensive care unit of a tertiary care hospital. The study population will be parents or guardians (older than 18 years) of children who have died in the unit at least 6 months prior to potential participation in the study. Purposive sampling will be used to ensure sample diversity in relation to experiential variables. Families will be initially contacted by letter sent alongside the standard letter of condolences from the hospital, and then recruited in a subsequent telephone call. The sample size will be determined by data saturation. In-depth interviews will be conducted individually or in pairs. Parents will decide when, how, and where to conduct the interviews, which will be transcribed verbatim and examined using thematic discourse analysis. This study was awarded a grant in December 2020 and was approved by the Medical and Health Research Ethics Committee on December 21, 2020. Data collection started in April 2021, and the results are expected to be published in 2023. This project is intended to maintain, strengthen, and build on a particular line of research on end-of-life care with a focus on effective coping, spiritual well-being, and the adaptive grieving process. The results will contribute to establishing action guidelines that are both based on the discourses of parents who have experienced the death of a child and geared toward high-quality end-of-life care through dignified death and adaptive grief management. DERR1-10.2196/43756.

Factors Influencing the Clinical Adoption of Quantitative Gait Analysis Technologies for Adult Patient Populations With a Focus on Clinical Efficacy and Clinician Perspectives: Protocol for a Scoping Review.

Quantitative gait analysis can support clinical decision-making. These analyses can be performed using wearable sensors, nonwearable sensors, or a combination of both. However, to date, they have not been widely adopted in clinical practice. Technology adoption literature has highlighted the clinical efficacy of technology and the users' perspective on the technology (eg, ease of use and usefulness) as some factors that influence their widespread adoption. To assist with the clinical adoption of quantitative gait technologies, this scoping review will synthesize the literature on their clinical efficacy and clinician perspectives on their use in the clinical care of adult patient populations. This scoping review protocol follows the Joanna Briggs Institute methodology for scoping reviews. The review will include both peer-reviewed and gray literature (ie, conference abstracts) regarding the clinical efficacy of quantitative gait technologies and clinician perspectives on their use in the clinical care of adult patient populations. A comprehensive search strategy was created in MEDLINE (Ovid), which was then translated to 4 other databases: CENTRAL (Ovid), Embase (Ovid), CINAHL (EBSCO), and SPORTDiscus (EBSCO). The title and abstract screening, full-text review, and data extraction of relevant articles will be performed independently by 2 reviewers, with a third reviewer involved to support the resolution of conflicts. Data will be analyzed using content analysis and summarized in tabular and diagram formats. A search of relevant articles will be conducted in all 5 databases, and through hand-searching in Google Scholar and PEDro, including articles published up until December 2022. The research team plans to submit the final scoping review for publication in a peer-reviewed journal in 2023. The findings of this review will be presented at clinical science conferences and published in a peer-reviewed journal. This review will inform future studies designed to develop, evaluate, or implement quantitative gait analysis technologies in clinical practice. DERR1-10.2196/39767.

Co-designing a Sexual Health App With Immigrant Adolescents: Protocol for a Qualitative Community-Based Participatory Action Research Study

Canada is one of the world's most ethnically diverse countries, with over 7 million individuals out of a population of 38 million being born in a foreign country. Immigrant adolescents (aged 10 to 19 years) make up a substantial proportion of newcomers to Canada. Religious and cultural practices can influence adolescents' sexual attitudes and behaviors, as well as the uptake of sexual and reproductive health (SRH) services among this population. Adolescence is a time to establish lifelong healthy behaviors. Research indicates an alarming gap in adolescents' SRH knowledge, yet there is limited research on the SRH needs of immigrant adolescents in Canada. The purpose of this study is to actively engage with immigrant adolescents to develop, implement, and evaluate a mobile health (mHealth) intervention (ie, mobile app). The interactive mobile app will aim to deliver accurate and evidence-based SRH information to adolescents. We will use community-based participatory action research to guide our study. This research project will be conducted in 4 stages based on user-centered co-design principles. In Stage 1 (Empathize), we will recruit and convene 3 adolescent advisory groups in Edmonton, Toronto, and Vancouver. Members will be engaged as coresearchers and receive training in qualitative and quantitative methodologies, sexual health, and the social determinants of health. In Stage 2 (Define and Ideate), we will explore SRH information and service needs through focus group discussions with immigrant adolescents. In Stage 3 (Prototype), we will collaborate with mobile developers to build and iteratively design the app with support from the adolescent advisory groups. Finally, in Stage 4 (Test), we will return to focus group settings to share the app prototype, gather feedback on usability, and refine and release the app. Recruitment and data collection will be completed by February 2023, and mobile app development will begin in March 2023. The mHealth app will be our core output and is expected to be released in the spring of 2024. Our study will advance the limited knowledge base on SRH and the information needs of immigrant adolescents in Canada as well as the science underpinning participatory action research methods with immigrant adolescents. This study will address gaps by exploring SRH priorities, health information needs, and innovative strategies to improve the SRH of immigrant adolescents. Engaging adolescents throughout the study will increase their involvement in SRH care decision-making, expand efficiencies in SRH care utilization, and ultimately improve adolescents' SRH outcomes. The app we develop will be transferable to all adolescent groups, is scalable in international contexts, and simultaneously leverages significant economies of scale. PRR1-10.2196/45389.

An Electronically Delivered Person-Centered Narrative Intervention for Persons Receiving Palliative Care: Protocol for a Mixed Methods Study

In the health care setting, electronic health records (EHRs) are one of the primary modes of communication about patients, but most of this information is clinician centered. There is a need to consider the patient as a person and integrate their perspectives into their health record. Incorporating a patient's narrative into the EHR provides an opportunity to communicate patients' cultural values and beliefs to the health care team and has the potential to improve patient-clinician communication. This paper describes the protocol to evaluate the integration of an adapted person-centered narrative intervention (PCNI). This adaptation builds on our previous research centered on the implementation of PCNIs. The adaptation for this study includes an all-electronic delivery of a PCNI in an outpatient clinical setting. This research protocol aims to evaluate the feasibility, usability, and effects of the all-electronic delivery of a PCNI in an outpatient setting on patient-reported outcomes. The first objective of this study is to identify the barriers and facilitators of an internet-based-delivered PCNI from the perspectives of persons living with serious illness and their clinicians. The second objective is to conduct acceptability, usability, and intervention fidelity testing to determine the essential requirements for the EHR integration of an internet-based-delivered PCNI. The third objective is to test the feasibility of the PCNI in an outpatient clinic setting. Using a mixed method design, this single-arm intervention feasibility study was delivered over approximately 3 to 4 weeks. Patient participant recruitment was conducted via screening outpatient palliative care clinic schedules weekly for upcoming new palliative care patient visits and then emailing potential patient participants to notify them about the study. The PCNI was delivered via email and Zoom app. Patient-reported outcome measures were completed by patient participants at baseline, 24 to 48 hours after PCNI, and after the initial palliative care clinic visit, approximately 1 month after baseline. Inclusion criteria included having the capacity to give consent and having an upcoming initial outpatient palliative care clinic visit. The recruitment of participants began in April 2021. A total of 189 potential patient participants were approached via email, and 20 patient participants were enrolled, with data having been collected from May 2021 to September 2022. A total of 7 clinician participants were enrolled, with a total of 3 clinician exit interviews and 1 focus group (n=5), which was conducted in October 2022. Data analysis is expected to be completed by the end of June 2023. The findings from this study, combined with those from other PCNI studies conducted in acute care settings, have the potential to influence clinical practices and policies and provide innovative avenues to integrate more person-centered care delivery. DERR1-10.2196/41787.