Background: Digital interventions for mental health are pivotal for addressing barriers such as stigma, cost, and accessibility, particularly for underserved populations. While the effectiveness of digital interventions has been established, poor adherence and lack of engagement remain critical factors that undermine efficacy. Millions of individuals will never have access to a trained mental health care practitioner, underscoring the need for highly tailored and engaging self-guided resources. This study builds on a prior study that successfully leveraged behavioral economics (nudges and prompts) to enhance engagement. Expanding on that study, this research will focus on building a foundational dataset of behavioral phenotypes to support artificial intelligence (AI)–driven personalization in digital mental health. Objective: This 6-arm randomized controlled trial aims to analyze user engagement with randomized tips and to-do lists within a resiliency course tailored for Ukrainian refugees affected by the ongoing humanitarian crisis (Спільна Сила), using the EvolutionHealth.care (V-CC Systems Inc) platform. Insights will inform the development of an AI-based personalization system to optimize engagement and address behavioral health challenges. Secondary objectives include identifying demographic and behavioral predictors of engagement and creating a scalable, culturally sensitive intervention model. Methods: Participants will be recruited through digital outreach, enrolled anonymously, and randomized into 6 groups to compare combinations of tips, nudges, and to-do lists. Engagement metrics (eg, clicks, completion rates, and session duration) and demographic data (eg, age and gender) will be collected. Statistical analyses will include a comparison between arms and interaction testing to evaluate the effectiveness of each intervention component. Ethical safeguards include institutional review board approval, informed consent, and strict data privacy standards. Results: This protocol was designed in January 2025. α and β testing of the intervention are scheduled to begin in July 2025, with a soft launch anticipated in August 2025. The experiment will remain active until the sample size requirements are met. Live monitoring and periodic data quality checks will be conducted throughout the study duration. Conclusions: This trial represents a novel approach to behavioral health research by leveraging randomized experimentation to develop AI-ready behavioral datasets. By targeting an underserved and culturally sensitive population, it contributes critical insights toward scalable, personalized digital mental health interventions. Findings may help inform future digital health efforts that aim to improve engagement, accessibility, and long-term adherence. Trial Registration: Open Science Framework 34rmg; https://osf.io/34rmg

Background: The use of artificial intelligence (AI) technologies in radiography practice is increasing. As this advanced technology becomes more embedded in radiography systems and clinical practice, the role of radiographers will evolve. In the context of these anticipated changes, it may be reasonable to expect modifications to the competencies and educational requirements of current and future practitioners to ensure successful AI adoption. Objective: The aim of this scoping review is to explore and synthesize the literature on the adjustments needed in the radiography curriculum to prepare radiography students for the demands of AI-assisted health care environments. Methods: Using the Joanna Briggs Institute methodology, an initial search was run in Scopus to determine whether the search strategy that was developed with a library specialist would capture the relevant literature by screening the title and abstract of the first 50 articles. Additional search terms identified in the articles were added to the search strategy. Next, EBSCOhost, PubMed, and Web of Science databases were searched. In total, 2 reviewers will independently review the title, abstract, and full-text articles according to the predefined inclusion and exclusion criteria, with conflicts resolved by a third reviewer. Results: The search results will be reported using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist. The final scoping review will present the data analysis as findings in tabular form and through narrative descriptions. The final database searches were completed in October 2024 and yielded 2224 records. Title and abstract screening of 1930 articles is underway after removing 294 duplicates. The scoping review is expected to be finalized by the end of March 2025. Conclusions: A scoping review aims to systematically map the evidence on the adjustments needed in the radiography curriculum to prepare radiography students for the integration of AI technologies in the health care environment. It is relevant to map the evidence because increased integration of AI-based technologies in clinical practice has been noted and changes in practice must be underpinned by appropriate education and training. The findings in this study will provide a better understanding of how the radiography curriculum should adapt to meet the educational needs of current and future radiographers to ensure competent and safe practice in response to AI technologies. Trial Registration: Open Science Framework 3nx2a; https://osf.io/3nx2a

Background: Malignant neoplasms are among the most common causes of disease-related death in children. Long-term chemotherapy often requires a high degree of parental involvement. Family caregivers’ preparedness and capacity are critical in reducing the burden of care and improving quality of life. This study looks to examine the impact of a family-centered empowerment model (FCEM)–based intervention on the caregiving capacity and preparedness of family caregivers. Objective: This study aims to develop and evaluate an FCEM-based intervention to improve caregiving preparedness and capacity among family caregivers of children with malignant neoplasms. It also examines the potential effects of the intervention on self-efficacy and psychological outcomes, including depression, anxiety, and stress. Methods: This quasi-experimental study focuses on caregivers of children with malignant neoplasms attending our hospital for the first time, implementing a 4-phase FCEM-based intervention program evaluated through questionnaires administered 3 days after admission and 3 days before discharge. Differences in caregiving preparedness, caregiving capacity, self-efficacy, and depression, anxiety, and stress scores will be assessed using independent and paired t tests, Mann-Whitney tests, and paired rank-sum tests for both within-group and between-group comparisons preintervention and postintervention. Results: Recruitment will be conducted in 2 waves (control group: July to December 2025; intervention group: July to December 2026). It is expected that the intervention group will show significantly greater improvements in caregiving preparedness, caregiving capacity, and psychological well-being compared to the control group. Conclusions: The findings of this study are expected to provide evidence for the development of structured family empowerment in pediatric oncology. In the future, expanding to multiple centers and conducting targeted surveys among caregivers of children with different cancer types would help validate and promote the effectiveness of family empowerment interventions. Trial Registration: ClinicalTrials.gov NCT06810388; https://clinicaltrials.gov/study/NCT06810388

Background: Breast cancer is the second most common cancer in women worldwide. Treatments for this disease often result in side effects such as pain, fatigue, loss of muscle mass, and reduced quality of life. Physical exercise has been shown to effectively mitigate these side effects and improve the quality of life in patients with breast cancer. Objective: This randomized clinical trial aims to evaluate the efficacy of a 12-week supervised exercise program on pain, physical function, and quality of life in female patients with cancer. Methods: This randomized, double-blind clinical trial will recruit 325 participants, divided into an intervention group receiving the exercise program and a control group receiving standard care recommendations. Outcome measures, including pain (assessed via the Brief Pain Inventory), physical function (Disability of the Arm, Shoulder, and Hand Questionnaire), and quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 and European Organization for Research and Treatment of Cancer QLQ-BR23), will be evaluated at baseline, immediately post intervention, and 12 weeks post intervention. Statistical analysis will involve repeated measures of ANOVA and MANOVA to determine the significance of the intervention’s effects across time points. Results: Recruitment and data collection will commence in February of 2025, and data analysis is scheduled for completion at the end of 2025. No results are currently available Conclusions: Physical exercise is anticipated to play a significant role in alleviating pain, enhancing physical function, and improving the quality of life in female patients with cancer. This study will provide robust evidence to support the integration of supervised exercise into standard care protocols for this population. Trial Registration: ClinicalTrials.gov NCT06618690; https://clinicaltrials.gov/ct2/show/NCT06618690

Background: Integrating digital entrustable professional activities (EPAs) and simulations in medical education represents a substantial shift toward competency-based learning. This approach focuses on developing specific skills through manageable units and enhancing proficiency in high-stakes environments. The technology acceptance model provides a framework to evaluate the adoption of these educational technologies, emphasizing the roles of perceived usefulness and ease of use. Objective: This cohort study aims to investigate the acceptance of digital EPAs among medical students within simulated training environments. It seeks to understand how perceived usefulness and ease of use influence this acceptance, guided by the principles of the technology acceptance model. Methods: The cohort study will involve medical students in the clinical phase of their education at Ludwig Maximilians University Munich. The survey, distributed through the Module-6 distributor, will capture their perceptions of digital EPAs. The data will be analyzed using regression analysis. Results: Data collection is anticipated to be complete by April 2025, with analysis concluded by May 2025. The results will provide insights into students’ attitudes toward digital EPAs and their willingness to integrate these tools into their learning. Conclusions: This study will contribute to the understanding of digital EPAs’ role in medical education, potentially guiding future design and implementation of these tools. While highlighting the importance of perceived usefulness and ease of use, the study also acknowledges limitations in sample size and recruitment methodology, indicating the need for further research with more diverse and larger groups. This research is poised to shape future medical training programs, aligning with the evolving landscape of medical education.

Background: Human-centered design (HCD) methodologies such as design thinking (DT), user-centered design, cocreation, and participatory design (PD) have been adopted to facilitate user and stakeholder involvement in the development of eHealth applications. However, there is frequent confusion around these methodologies, leading to the fragmentation of the discourse and limited integration opportunities. The absence of an empirically grounded framework for HCD limits research and theoretical consensus, particularly in the highly regulated context of eHealth solution development. For this scoping review, the term HCD will be used as an umbrella term, under which the terms user-centered design, patient-centered design, cocreation, co-design, PD, and DT will be used in this protocol. Objective: In this paper, we describe a protocol for a scoping review that aims to explore and analyze the scope, definitions, key concepts, and motivations reported in peer-reviewed studies that have applied stakeholder engagement methods such as HCD, PD, or DT in developing eHealth applications. Methods: A team of 3 reviewers will conduct this scoping review to identify and synthesize key concepts at the intersection of HCD methodologies and their application to the development of eHealth applications. We will follow the Joanna Briggs Institute methodology for scoping reviews and the guidelines for conducting systematic mapping studies in software engineering. The reporting of the results will be guided by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) extension. This review will include only primary studies reporting on the experience, challenges, and applicability of HCD for the design and development of eHealth applications, identified through the PubMed, IEEE Xplore, Web of Science, Scopus, PsycINFO, CINAHL, and ACM Digital Library databases, and limited to articles from the past 10 years. Results: A preliminary search applying the search strategy resulted in 826 records. The search was initiated in March 2025. Title and abstract screening will conclude by mid-2025, followed by full-text screening, data extraction, and analysis in the second half of 2025. Results are expected to be submitted for publication in the first half of 2026. Conclusions: This protocol describes a systematic approach for conducting a scoping literature review, aimed at synthesizing definitions, concepts, and methodologies related to HCD in eHealth application development. This review aims to identify research gaps and trends to guide the future of mobile health innovation, with a focus on improving adoption and long-term sustainability, particularly from the perspective of technologies for vulnerable populations.

Background: Thoracic trauma accounts for 10% to 15% of trauma-related hospital admissions and contributes significantly to morbidity and mortality. Rib fractures, the most common thoracic injury, often result in pulmonary complications such as pneumonia and atelectasis due to impaired respiratory mechanics. Incentive spirometry (IS) is a widely used noninvasive technique aimed at improving pulmonary function after injury, yet patient compliance remains a challenge. Gamification of respiratory therapy has emerged as a promising approach to enhance engagement and adherence. Objective: This paper presents the protocol for a study to evaluate the feasibility and safety of using gamified IS through the OmniFlow Breathing Therapy BioFeedback System in trauma patients. While preliminary observations related to potential clinical efficacy (eg, respiratory function and adherence) are of interest, structured clinical or physiological end points are not included in this protocol for a pilot study and are planned for future trials. Methods: This protocol is for a single-center, prospective, observational phase 2 pilot study to be conducted at Wake Forest Baptist Medical Center. Adult patients (aged ≥18 years) admitted to the trauma intensive care unit with rib fractures and a Glasgow Coma Scale score of 15 are eligible for inclusion if their first intervention session can occur within 48 hours of admission. Patients requiring mechanical ventilation, those with baseline lung disease, and those with contraindications to IS are excluded. Enrolled patients participate in at least one gamified respiratory therapy session daily, lasting 15 to 20 minutes, with the possibility of additional sessions based on patient preference and tolerance. Primary end points include the feasibility of enrolling 20 patients and their participation in at least one session. Secondary end points evaluate patient adherence, number of completed sessions, and session interruptions due to predefined safety criteria (eg, pain score >8/10, oxygen desaturation <92%, new cardiac arrhythmia, or respiratory distress). If 5 consecutive patients fail to complete a session due to adverse events, the intervention is deemed unsafe. Results: The study was approved by the institutional review board of Atrium Health Wake Forest Baptist Medical Center and was registered at ClinicalTrials.gov. However, no participants were ever enrolled, as the OmniFlow partners did not supply the device for the study. Despite this, it remains a potentially beneficial tool, and future studies may confirm its benefits once the device becomes available. Conclusions: OmniFlow offers a promising, much-needed solution for promoting adherence to breathing exercises among patients with thoracic trauma. This study protocol is designed to evaluate its safety and feasibility in patients with thoracic trauma and rib fractures. Looking ahead, incorporating multiplayer games into the platform could further enhance its effectiveness, allowing patients to engage in group activities while working toward their individual therapeutic goals.

Background: Misuse of prescription opioids remains a public health problem. Appropriate short-term use of these medications in opioid-naive patients is indicated in selected settings but can result in unintended prolonged opioid use (UPOU), defined as the continuation of opioid therapy beyond the period by which acute pain would have been expected to resolve. Clinical strategies aimed at preventing UPOU are lacking due to the absence of information about how this poorly understood clinical phenomenon actually develops. Objective: In this research project, 3 Clinical and Translational Science Awards (CTSA) programs (Mayo Clinic, University of Michigan, and Yale University) leveraged the conceptual framework for UPOU to investigate how patient characteristics, practice environment characteristics, and opioid prescriber characteristics facilitate or impede UPOU. All data management and analyses were conducted at a fourth CTSA program (University of Minnesota). This work was accomplished by pursuing 3 specific aims. Methods: In aim 1, opioid-naive adults receiving an initial opioid prescription were recruited for study participation. Opioid prescriptions were identified longitudinally, and patterns of use were categorized as short-term, episodic, or long-term use using established criteria. Using a prospective case-control design, patients progressing to UPOU were matched 1:1 with patients who did not develop UPOU, and differences in patient characteristics were assessed. In aim 2, clinicians who prescribed opioids to patients in aim 1 were identified and recruited for prospective assessments. Institutional and individual practice environments were assessed using a validated self-report survey. In aim 3, structural equation modeling was used to evaluate data collected in aims 1 and 2, and identified interactions were further evaluated in a large national administrative claims database. Results: Patient recruitment began on August 1, 2019. However, due to the COVID-19 pandemic, patient recruitment was slowed and intermittently interrupted over the ensuing 3-year period. As a result of regional variations in the impact of the COVID-19 pandemic on research activities, the majority of patient and clinician recruitment occurred at the Mayo Clinic site. Conclusions: Following complete data analyses, it is anticipated that electronic health record systems will be leveraged to help clinicians identify at risk patients and to develop direct-to-patient educational materials to raise awareness of the risk factors for developing UPOU. Trial Registration: ClinicalTrials.gov NCT04024397; https://clinicaltrials.gov/study/NCT04024397

Background: Comprehensive and formalized digital health care ecosystems in health sciences tertiary education in South Africa do not currently exist, but they have the potential to influence teaching and learning, research, and community engagement. Objective: A total of 3 key objectives underpin the study, that is, determining the health care curriculum needs and required content for the development of a formalized digital health ecosystem, determining the level of readiness of staff and students to participate in a digital health care ecosystem, and determining whether community engagement and strategic partnerships can contribute to the sustainability of a digital health care ecosystem. Methods: A multipronged approach will be used to address the objectives, with a mixed methods design being undertaken. The qualitative phases will be phenomenological in nature, and triangulation of information along with thematic analysis will be conducted on the collected data. Quantitative data will be collected prospectively and cross-sectionally and analyzed using descriptive analysis. Sampling will include subject experts for the Delphi technique, staff and students at the University, clinical training and education partners, and community leaders. This study has received ethical approval from the Sefako Makgatho Health Sciences University Research and Ethics Committee (SMUREC/H/260/2023:PG). Results: Data collection for the first phase will begin in January 2024 and conclude in December 2024. Phase 2 and 3 of the study will be conducted concurrently, with data collection starting in January 2025 and concluding in December 2026. Conclusions: The establishment of a digital health care ecosystem has the potential to benefit staff, students, and communities through stakeholder collaboration, educational opportunities, research projects, and improved service delivery.

Background: Regulating gestational weight gain (GWG) in pregnant women with overweight or obesity is difficult, particularly because of the narrow range of recommended GWG for optimal health outcomes. Given that many pregnant women show excessive GWG and considering the lack of a “gold standard” intervention to manage GWG, there is a timely need for effective and efficient approaches to regulate GWG. We have enhanced the Healthy Mom Zone (HMZ) 2.0 intervention with a novel digital platform, automated dosage changes, and personalized strategies to regulate GWG, and our pilot study demonstrated successful recruitment, compliance, and utility of our new control system and digital platform. Objective: The goal of this paper is to describe the study protocol for a randomized controlled optimization trial to examine the efficacy of the enhanced HMZ 2.0 intervention with the new automated control system and digital platform to regulate GWG and influence secondary maternal and infant outcomes while collecting implementation data to inform future scalability. Methods: This is an efficacy study using a randomized controlled trial design. HMZ 2.0 is a multidosage, theoretically based, and individually tailored adaptive intervention that is delivered through a novel digital platform with an automated link of participant data to a new model-based predictive control algorithm to predict GWG. Our new control system computes individual dosage changes and produces personalized physical activity (PA) and energy intake (EI) strategies to deliver just-in-time dosage change recommendations to regulate GWG. Participants are 144 pregnant women with overweight or obesity randomized to an intervention (n=72) or attention control (n=72) group, stratified by prepregnancy BMI (<29.9 vs ≥30 kg/m2), and they will participate from approximately 8 to 36 weeks of gestation. The sample size is based on GWG (primary outcome) and informed by our feasibility trial showing a 21% reduction in GWG in the intervention group compared to the control group, with 3% dropout. Secondary outcomes include PA, EI, sedentary and sleep behaviors, social cognitive determinants, adverse pregnancy and delivery outcomes, infant birth weight, and implementation outcomes. Analyses will include descriptive statistics, time series and fixed effects meta-analytic approaches, and mixed effects models. Results: Recruitment started in April 2024, and enrollment will continue through May 2027. The primary (GWG) and secondary (eg, maternal and infant health) outcome results will be analyzed, posted on ClinicalTrials.gov, and published after January 2028. Conclusions: Examining the efficacy of the novel HMZ 2.0 intervention in terms of GWG and secondary outcomes expands the boundaries of current GWG interventions and has high clinical and public health impact. There is excellent potential to further refine HMZ 2.0 to scale-up use of the novel digital platform by clinicians as an adjunct treatment in prenatal care to regulate GWG in all pregnant women.

Background: Individuals with non-Western backgrounds consistently exhibit a higher risk of type 2 diabetes (T2D) than ethnic Danes. Factors such as health behaviors, limited health care access, and social determinants of health often contribute to this disparity. Culturally sensitive interventions are crucial; however, effective interventions for managing T2D in non-Western populations remain limited. Objective: This study aims to examine the effect of a 1-year person-centered and culturally sensitive intervention on improving glycemic control (hemoglobin A1c [HbA1c]) in Arabic-, Turkish-, or Urdu-speaking individuals with T2D. The secondary objectives are to improve diabetes management and overall well-being. Methods: This study is designed as a 2-arm randomized controlled trial. A total of 96 women and men with T2D (HbA1c≥53 mmol/mol) speaking either Arabic, Turkish, or Urdu as their native language will be randomized for 1 year to a health care professional–assisted intervention group (person-centered and culturally sensitive course of treatment) or a control group (usual care) in a 1:1 ratio in Denmark. Assessments are scheduled at baseline and 1 year. The primary outcome is HbA1c, while lipids, blood pressure, and patient-reported outcomes, including well-being, diabetes management, health literacy, and use of and adherence to diabetes medication, are secondary outcomes. Feasibility and satisfaction are evaluated through interviews. The study is approved by the Ethics Committee of the Capital Region of Denmark (H-23042245). Results: A 5.0-mmol/mol change in HbA1c is the minimally important difference, requiring 88 participants. To allow for uncertainties and dropouts, the total was increased to 96. As of January 2025, a total of 88 participants have been recruited. Recruitment was completed in March 2025. Data collection will continue until December 2025, with the first results expected by March 2026. Conclusions: This study will contribute to the limited knowledge regarding the effects of person-centered and culturally sensitive treatment approaches for T2D in Arabic-, Turkish-, or Urdu-speaking individuals. The study uses a robust methodological design and will present an alternative avenue for managing T2D and improving overall well-being. The study offers valuable insights into the experiences of participants and health care professionals, including potential obstacles and strategies for implementation in outpatient clinics. Trial Registration: ClinicalTrials.gov NCT06147245; https://clinicaltrials.gov/study/NCT06147245

Background: Mobile health (mHealth) interventions that leverage social support (SS) can improve partner involvement and pregnancy experiences and promote antenatal care (ANC) attendance and skilled births. In our previous studies, we used behavioral frameworks to develop a user-centered mHealth-based, audio SMS text messaging app to support pregnant individuals to use maternity care services in rural Uganda (Support-Moms app). In our pilot study, we observed high intervention uptake, acceptability, and feasibility, as well as increased ANC attendance and skilled births. Objective: With the promising pilot data, we propose a type 1 hybrid implementation-effectiveness trial to test if this novel patient-centered automated and customized mHealth-based SS intervention is effective and cost-effective enough to warrant future large-scale implementation into Uganda’s routine maternity care. Methods: We will physically recruit 824 pregnant women at <20 weeks of gestation living in Mbarara and Mitooma districts, southwestern Uganda, and randomize them (1:1) to receive standard of care or the Support-Moms app, with at least 2 of their identified social supporters. Our primary outcome will be the proportion of skilled births. Secondary outcomes will include number of ANC visits<strong>,</strong> institution-based delivery, mode of infant delivery, preterm birth, birth weight, SS, obstetric complications, and deaths (maternal, fetal, and newborn). We will assess other implementation, service, and client outcomes through study records, the mHealth platform, and questionnaires with all women in the intervention, their social supporters, health care providers (HCPs), and managers from participating facilities. We will conduct face-to-face in-depth exit interviews with 30 purposively selected intervention participants and 15 facility HCPs and managers to explore implementation strategies for scale-up. Annual maternity resource allocations, costs, number of ANC visits, and deliveries will be assessed from facility records up to 36 months after implementation. We will estimate incremental cost-effectiveness ratios concerning cost per additional HCP-led delivery, per death averted, and per quality-adjusted life year gained as cost-effectiveness measures. Results: This study was funded in September 2023. Ethics approval was obtained in February 2024, and actual data collection started in March 2024. As of January 2025, 75% (618/824) of all projected study participants provided consent and were recruited into the study. Participants are expected to be followed up until delivery, and 15% (124/824) have so far exited. Data analysis for the trial is expected to start as soon as the last participant exits from the study. The qualitative interviews will start in April 2025, and data will be analyzed and published as soon as data collection is done, which is expected in March 2027. Conclusions: We are testing the feasibility, acceptability, and cost-effectiveness of implementing Support-Moms into routine maternity care from individual and facility perspectives. We hypothesize that Support-Moms will be an effective and cost-effective strategy to improve maternity service use for women in rural Uganda and similar settings. Trial Registration: ClinicalTrials.gov NCT05940831; https://clinicaltrials.gov/study/NCT05940831

Background: Type 1 diabetes (T1D) is a growing global health concern, with a notable rise in incidence in Saudi Arabia. Despite the potential benefits of early detection through screening programs, such initiatives are currently lacking in Saudi Arabia and other Arab countries. Objective: This study aims to evaluate the feasibility, acceptability, and cost-effectiveness of a T1D-screening program targeting high-risk individuals, specifically children with a first-degree relative diagnosed with T1D. Methods: The VISION-T1D program is a prospective cohort study focused on the early detection of presymptomatic T1D by screening children aged 2-18 years. The primary screening method involves testing for islet autoantibodies, including insulin autoantibodies, glutamic acid decarboxylase autoantibodies, insulinoma associated-2 autoantibodies, and zinc transporter-8 autoantibodies. Optional genetic testing, including human leukocyte antigen phenotyping and the genetic risk score, is offered. Outcomes include the feasibility of the screening process, prevalence of early-stage T1D, psychological impacts, educational intervention effectiveness, progression rates to stage-3 T1D, and economic viability. Results: The VISION-T1D program began in May 2024. As of December 2024, a total of 176 families have been enrolled. Data collection will continue until April 2025, with final data analysis projected for mid-2025. Conclusions: The VISION-T1D study provides a practical approach to T1D screening tailored to the health care landscape of Saudi Arabia. The insights gained from this pilot program will inform the development of a national, population-based screening initiative designed to reduce diabetic ketoacidosis at diagnosis, improve long-term outcomes, and alleviate the economic burden of T1D. The VISION-T1D initiative could also serve as a scalable and sustainable model that can be adopted internationally, contributing to global efforts to manage and prevent T1D. Trial Registration: ClinicalTrials.gov NCT06513247; https://clinicaltrials.gov/study/NCT06513247

Background: Transgender women face significant health inequities. Facial feminization surgery is an intervention that aligns craniofacial structures with female anatomical norms and gender identity. Although international studies suggest that facial feminization surgery improves psychosocial outcomes, most studies have focused on aesthetic results or relied on generic quality-of-life instruments that have not been validated for this population. In Chile, no study has evaluated the multidimensional impact of facial feminization surgery using patient-centered measures combined with objective cephalometric and photometric analyses. Moreover, no validated Spanish-language quality-of-life instrument exists for transgender women undergoing this surgery.

Background: Lifestyle is a key determinant of physical and mental health. Reducing unhealthy behaviors, such as inadequate sleep, physical inactivity, and poor diet among children and adolescents may prevent serious long-term consequences on physical and mental health. However, empirical evidence on the temporal dynamic interrelationships of multiple behavioral health domains is scarce. Here, we describe the protocol of the mSanté pilot study, which examines the temporal relationships between sleep, physical activity, diet, and emotional states in school-aged youth using ambulatory assessments. Objective: The objective of the pilot study is to assess the feasibility of prolonged ambulatory assessment within school and clinical samples, and to lay the methodological groundwork for introducing developmental/idiographic models of health behaviors that inform about individual trajectories of risk and resilience. Methods: We aim to collect data from preadolescent and adolescent youth aged 9-17 years in diverse school and clinical settings. Beyond baseline information on demographic characteristics, health behaviors, social functioning, medical and psychological health, participants will engage in multiple waves of intensive longitudinal assessments on multiple timescales. These will include continuous actigraphy and Ecological Momentary Assessment (EMA) accompanied by repeated trait-level self-reports. Subsequent analyses will consist of: (1) fragmentation analysis to quantify subject-specific stability; (2) functional principal component analysis using the actigraphy dataset; (3) multilevel regression models to assess specific within-person processes; (4) generalized estimating equations and network modeling to explore the temporal dynamic associations of health behaviors with emotional states. Results: As of December 2024, we enrolled 13 preadolescent patients from an outpatient unit where recruitment and data collection are still ongoing, as well as 27 preadolescents, and 113 adolescents recruited from schools. Conclusions: This study delves into the developmental dynamics of mental and physical health in emerging adolescence through detailed, longitudinal momentary assessments, providing valuable insights into the interplay between health behaviors during late childhood and adolescence. Despite challenges such as sample bias, the research sets a significant foundation for future large-scale studies aimed at dissecting the complex developmental trajectories of risk and resilience. Clinical Trial: OSF Registries osf.io/s2jm6; https://osf.io/s2jm6

Background: Hypertension affects 31% of the global adult population. Artificial intelligence–based chatbots may support self-management of hypertension and other chronic disorders. Chronic Disease Management Program (CHAMP) is a digital health intervention designed to support chronic disease self-management, comprising a patient-facing chatbot and an artificial intelligence–augmented clinical decision support system linked to electronic medical records. Objective: This project aims to optimize the deployment of CHAMP across primary care centers by developing implementation strategies and pilot-testing their appropriateness and effectiveness. Methods: We report 3 interlinked studies. Study 1 is a rapid evidence review to evaluate the factors influencing the implementation of mobile health and chatbot interventions in health care settings and the strategies and processes involved. We will follow the Cochrane Rapid Reviews Methods Group methodology and use the Consolidated Framework for Implementation Research and the unified theory of acceptance and use of technology frameworks to analyze the data. Study 2 is a formative, mixed methods study to inform the state of CHAMP deployment to date, the organizational structure of primary care centers, and the barriers and facilitators influencing the implementation and scale-up of CHAMP in primary care centers. We will interview members of the CHAMP development and initial implementation team, health care providers (HCPs), primary care centers’ leadership, and patient users and nonusers of CHAMP; conduct 1-day on-site visits to primary care centers; and assess the readiness to change among HCPs using validated questionnaires. Study 3 involves the development of implementation strategies for the implementation of CHAMP in primary care centers. We will develop a process map informed by the findings of studies 1 and 2 to outline the patient journey; map the barriers and facilitators influencing the implementation of CHAMP; and develop a set of implementation strategies to effectively implement CHAMP using the Expert Recommendations for Implementing Change taxonomy to define the implementation strategies and the action, actor, context, target, and time framework to define the strategy implementation processes. In parallel, we will use evidence-based behavioral science to test variations of the chatbot’s messages to increase patient engagement. Results: To date, the evidence review protocol (study 1) has been registered on PROSPERO. We have completed title and abstract screening and are in the full-text screening phase. For study 2, we obtained ethics approval and conducted the semistructured interviews with HCPs, primary care centers’ leadership, and members of the CHAMP development and initial implementation team. We are awaiting institutional review board approval to start the interviews with patients. Conclusions: The study results will inform the further implementation and scale-up of CHAMP across primary care centers in Singapore. Successful implementation of digital health interventions to support self-management of chronic disorders may improve health care delivery without further straining health care systems.

Background: Male adolescents have significant sexual and reproductive health (SRH) needs and, despite the existence of national guidelines, their SRH care receipt remains poor. Technology-based interventions have been shown to successfully support adolescents’ SRH; however, they have primarily focused on female individuals. To date, no such solutions support comprehensive SRH care delivery for male adolescents in primary care settings. Health-E You/Salud iTu (Health-E You) is a mobile web app that was originally designed for female youth and has proven to be effective in improving contraceptive care delivery and use. Adolescents access the app ahead of a clinic appointment, which contains initial screening questions, interactive knowledge items, and contraception decision support with tailored recommendations based on the users’ input. The app then provides clinicians with a summary of patients’ recommended SRH care.

Background: Body image distress (BID) is a significant psychological issue for patients with head and neck cancer (HNC) and arises from the visible disfigurements and functional impairments often associated with the disease and its treatment. Understanding the factors contributing to BID in this population is crucial for developing effective interventions and support mechanisms. Objective: This systematic review outlines methods for identifying, evaluating, and synthesizing the available evidence on factors associated with BID among patients with HNC. This review intends to explore both clinical and psychosocial variables that may influence body image perceptions and the resulting psychological impact. Methods: This review will follow the Joanna Briggs Institute (JBI) Reviewer’s Manual for Systematic Reviews Concerning Etiology and Risk Factors. PsycINFO, MEDLINE, EBSCOhost CINAHL, Web of Science, Cochrane Library, and Embase were searched for relevant studies from inception to December 2024. All in-depth quantitative analyses, descriptive observational studies, experimental studies, and quasi-experiments published in English or Chinese were analyzed and described. Studies examining factors associated with BID in patients with HNC were included. The population, exposure, comparison, and outcome (PECO) format was used to develop the search strategy. For different databases, search terms will be combined using Boolean operators. The JBI Risk of Bias Tool was used to evaluate bias risk in the included studies. The extracted data will include basic study information, research design, sample characteristics, BID measurement tools, primary outcomes, statistical analysis methods, and quality assessment results. Subgroup and meta-regression analyses will be performed on different therapies, treatment stages, genders, ages, cultural backgrounds, etc. I2 statistics will be used to evaluate heterogeneity, and funnel plots will address publication bias. If we detect significant heterogeneity, the findings will be reported as a systematic review without a meta-analysis. Results: The database search will be conducted in October 2025. It is anticipated that the study findings will be submitted for publication in a peer-reviewed journal by the end of March 2026. Conclusions: This study will summarize the factors that can help identify and evaluate the factors associated with BID in patients with HNC, providing up-to-date evidence to inform the management of body image in this patient population. JMIR RESEARCH PROTOCOLS Xu et al

Background: Intravenous ketorolac is a potent nonopioid analgesic commonly used to treat vigorous pain in children and adults. Despite its widespread use in pediatric emergency settings, ketorolac dosing in children remains “off-label,” with limited high-quality evidence to guide practice. Pharmacokinetic differences between children and adults suggest that lower ceiling doses adopted from adult practice may lead to suboptimal analgesia in pediatric populations. Inconsistent ketorolac dosing practices across centers reflect substantial clinical uncertainty. Amid efforts to reduce opioid use and provide effective nonopioid alternatives, rigorous pediatric trials evaluating ketorolac dosing are urgently needed. Objective: The primary objective is to determine whether 2 lower-dose intravenous ketorolac strategies (0.25 mg/kg-30 mg or 0.5 mg/kg-10 mg) are noninferior to the standard dosing regimen (0.5 mg/kg-30 mg) in reducing mean pain scores at 60 minutes postadministration in children aged 6-17 years presenting with vigorous pain. The secondary hypothesis is that ketorolac 0.5 mg/kg up to 10 mg will be superior to 0.25 mg/kg up to 30 mg by at least the minimally important difference of 2.0 points on the verbal Numerical Rating Scale (vNRS). Methods: The KETODOSE trial is a single-center, randomized, double-blind, double-dummy, noninferiority trial conducted at McMaster Children’s Hospital. Eligible participants aged 6 to <18 years with vigorous pain (vNRS >4) are randomized in a 1:1:1 ratio to standard dosing or one of 2 low-dose ketorolac regimens. Study drugs are administered via intravenous push over 5 minutes. Pain scores are assessed at baseline, 30, 60, 90, and 120 minutes. The primary endpoint is the mean change in vNRS score at 60 minutes. Secondary outcomes include pain scores at other time points, time to effective analgesia, rescue analgesia requirements, opioid consumption, and adverse events. Caregiver perceptions regarding analgesic use are evaluated using a mixed-methods semistructured survey. A sample size of 180 participants (60 per group) provides 80% power to detect noninferiority within a margin of 1.0 on the vNRS, assuming an SD of 1.5. Intention-to-treat and per-protocol analyses will be performed. Results: Recruitment is ongoing. Final analyses will be performed once follow-up is completed for all participants. Results will be disseminated through peer-reviewed publications, conference presentations, caregiver- and clinician-facing educational tools, and national knowledge mobilization networks. Conclusions: The KETODOSE trial will provide urgently needed evidence to guide ketorolac dosing for acute pain in children. If lower-dose regimens are shown to be noninferior to standard dosing, this may promote safer prescribing practices, reduce adverse events, and support efforts to minimize pediatric opioid use, thereby improving acute pain management in pediatric emergency care. Trial Registration: ClinicalTrials.gov NCT05641363; https://clinicaltrials.gov/study/NCT05641363

Background: Drug-drug interactions (DDIs) are a major concern, especially for older adults taking multiple medications. Although Health Canada and the US Food and Drug Administration (FDA) use population-based studies to identify adverse drug events, detecting harmful DDIs is challenging due to the millions of potential drug combinations. Traditional pharmacoepidemiologic studies are slow and inefficient, often missing important harmful DDIs. Objective: This protocol outlines a novel approach to efficiently identify harmful DDIs using administrative health care data. Methods: Using high-throughput computing, we will conduct multiple population-based, new-user cohort studies using Ontario’s linked administrative health care data. The cohorts will be selected from the population of Ontario residents aged 66 years and older who filled at least one oral outpatient drug prescription from 2002 to 2023. In each cohort, the exposed group will comprise individuals who are regular users of one drug (drug A) who start a new prescription for a second drug (drug B); the referent group will comprise regular users of drug A not taking drug B. We will evaluate 74 acute outcomes within 30 days of cohort entry, including hospitalizations, emergency department visits, and mortality. Propensity score methods will balance exposed and referent groups on more than 400 baseline health characteristics. Modified Poisson and binomial regression models will estimate risk ratios (RRs) and risk differences (RDs). To ensure findings are both statistically and clinically meaningful, we will apply prespecified thresholds for effect sizes (eg, lower bounds of 95% CIs≥1.33 for RRs and ≥0.1% for RDs) and control the false discovery rate at 5% using the Benjamini-Hochberg procedure to address multiplicity. Subgroup and sensitivity analyses, including negative control outcomes and E-values, will assess robustness. Results: In a preliminary analysis, we identified approximately 3.8 million older adults who filled prescriptions for over 500 unique medications during the study period (2002-2023), and therefore, approximately 200,000 potential drug combinations will be available for study. The initial drug pair cohorts had a median of 583 new users per cohort (IQR 237-2130); the median overlap in drug pair prescriptions was 57 days (IQR 30-90). The protocol was finalized on August 30, 2025, and outlines the analysis of data from 2002 to 2023. The analysis is scheduled to be completed by fall 2026, with results interpreted in 2027. The final manuscript submission is planned for December 2028. Conclusions: This study aims to identify credible signals of harmful DDIs in older adults in routine care. This study will use an innovative approach that leverages data from provincial administrative health care databases and integrates high-throughput computing and rigorous pharmacoepidemiologic methods to generate robust real-world evidence that can inform safer prescribing practices and regulatory decision-making.

Background: Platinum salts are widely used for the treatment of cancers, including head and neck cancers. Despite their efficacy, platinum salts can induce neurosensory disorders such as ototoxicity, tinnitus, and decreased hearing acuity. Those side effects can have a major impact on the quality of life of patients and are not often considered after treatment. Objective: The study aims to compare the quality of life of patients with hearing aids in the case of ototoxicity due to platinum salt-based chemotherapy, according to two treatments: standard management without equipment versus standard management with equipment. Methods: PROTOTOX is an open pilot prospective monocentric and randomized study executed through collaboration of the Institut de Cancérologie de Lorraine (non-profit comprehensive cancer institute). 52 patients with head and neck cancer undergoing platinum-based chemotherapy and presenting with hypoacusis will be included and followed by an ear, nose and throat specialist. Audiometric testing will be performed, and eligible participants who consent will be randomized to either receive or not receive hearing aids (group 1 and 2). The primary endpoint of this study is to compare the quality of life of the patients undergoing platinum-based chemotherapy presenting with hypoacusis according to two ways of care: standard care without hearing aid versus standard care with hearing aid. Secondary outcomes are the evaluation of the hearing and the tinnitus, the evaluation of the patients’ satisfaction at the end of the study, and the evaluation of the patients’ adherence to hearing aid in case of ototoxicity due to platinum-based chemotherapy. Results: The study protocol has been opened and is actively recruiting participants. Conclusions: PROTOTOX study aims at demonstrating that the huge impact of platinum-based chemotherapy on hearing abilities must be managed to maintain the patients’ quality of life. Hearing aid is the solution experimented here. Clinical Trial: ClinicalTrials.gov NCT05936034; https://clinicaltrials.gov/study/NCT05936034.

Background: The term periodontium encompasses the supporting structures around a tooth, including gingival tissue, alveolar bone, cementum, and periodontal ligament. Periodontal disorders are highly prevalent, affecting approximately 95% of the Indian population. Restoring the missing attachment apparatus is the main goal of regenerative therapy in cases of periodontal disease. The reproduction or rebuilding of damaged or lost periodontal tissue to restore the structure and functionality of the periodontium is known as regeneration. This study investigates the effectiveness of autologous sticky bone (ASB), autologous platelet-rich fibrin (PRF), and octacalcium phosphate–coated deproteinized bovine bone material (OCP-DBBM). These materials are being evaluated for their potential to enhance bone regeneration in infrabony defects, which are a significant concern in periodontal therapy. Effective bone regeneration is critical for the successful treatment of periodontal defects, as it can lead to improved clinical outcomes, including better attachment levels and reduced probing depths. This study aims to provide insights into the most effective methods for achieving these goals. Objective: We aim to assess the efficacy of ASB and autologous PRF in conjunction with OCP-DBBM in infrabony defects at 6 months after surgery with regard to radiographic bone fill, reduction in probing pocket depth, and increase in clinical attachment level. Methods: This randomized controlled clinical trial will be performed on 20 defects in patients diagnosed with stage 2 and 3 grade B periodontitis. It will be a parallel-designed study where group 1 (n=10) will be treated with ASB and group 2 (n=10) will be treated with autologous PRF and OCP-DBBM. One sitting will be required to perform the treatment, and a follow-up checkup will be done at 6 months. Results: Recruitment procedures started in June 2025. All data are anticipated to be collected by February 2026. Full trial results are anticipated to be analyzed and submitted for publication by March 2026. The study’s anticipated end date is March 2026. Conclusions: Both treatment approaches are expected to lead to notable gains in periodontal health and bone regeneration. The primary outcome, radiographic bone fill, and the secondary outcomes, clinical attachment level gain and probing pocket depth reduction, are critical indicators of treatment success. Clinical Trial: Clinical Trials Registry-India CTRI/2024/06/069603; https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTAzODk0&Enc=&userName=

Background: US children’s diets are high in calories and are of poor nutritional quality, and a likely contributing factor is the consumption of food from restaurants. While children readily accept the sweet and salty foods that characterize restaurant children’s menus, research shows that their taste preferences are malleable, and regular exposure to healthier foods can promote their acceptance. Objective: We describe a cluster-randomized controlled trial testing the effects of behavioral intervention strategies (choice architecture and repeated exposure) on ordering and dietary intake among children in restaurants and present baseline demographic data for the study cohort. Methods: Six locations of a regional quick-service restaurant chain were randomized to the intervention or control group in pairs based on income in surrounding census tracts. Families with children aged 4 to 8 years were recruited and asked to complete 8 visits to the study restaurant, including a baseline assessment completed at the time of enrollment, followed by 6 visits during a designated 2-month exposure period and a final posttest assessment. Intervention content provided to intervention group families after baseline assessments includes placemats promoting 2 healthier kids’ meals and the opportunity to redeem their kids’ meal “cone token” for a toy instead of a dessert (choice architecture strategies). In addition, participating families receive frequent diner cards, which can be used to earn a free kids’ meal after purchasing a promoted kids’ meal 6 times (repeated exposure strategy). Families in control restaurants receive generic versions of these materials (eg, frequent diner cards that can be redeemed for a free kids’ meal after purchasing any 6 kids’ meals). The primary outcome is the meal ordered for the child at a posttest restaurant visit following the exposure period (ie, whether or not a promoted meal was ordered). Additional order data will include calories, saturated fat, sodium, and sugar content of children’s orders at posttest. Other outcomes include children’s in-restaurant and daily consumption of calories, saturated fat, sodium, and sugar. Results: This study was funded in 2019, with preregistration completed in 2020, data collection occurring from June 2021 to November 2024, and data processing, analysis, and primary outcome manuscript preparation in 2025-2026. A total of 236 families provided baseline data on children’s orders and comprise the study cohort; 234 of these families provided demographic data (n=184, 78.3% female parents; n=133, 56.8% female children; child mean age 6.5, SD 1.3 years). Conclusions: Given that restaurants are normative eating contexts for many children, this intervention has the potential to impact children’s dietary intake and health. If found to be successful, future directions could include scaling the current intervention approach and conducting further effectiveness, implementation, and dissemination research to understand its applicability and impact across different types of restaurants and sociodemographic contexts. Trial Registration: ClinicalTrials.gov NCT04334525; https://clinicaltrials.gov/study/NCT04334525

Background: Mobile health (mHealth) technology is widely used in health care systems globally to improve patients’ quality of life and reduce the burden on caregivers. Mobile apps allow users to manage different health-related situations from their homes, such as self-monitoring their symptoms, keeping track of progress, and maintaining a profile for a particular condition. However, the benefits of mHealth apps are compromised due to a lack of sustainability evaluation. Currently, there is a lack of all-inclusive research that presents sustainability evaluation from economic, social, and environmental perspectives of mHealth and wearables. Thus, it is important to evaluate the sustainability of newly proposed or already in-use mHealth solutions. Objective: The objective of this systematic literature review is to deeply understand and analyze different dimensions of sustainability in the health care domain and identify existing evaluation criteria and frameworks for mHealth solutions. Methods: This protocol was developed following the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) guidelines. A planned and systematic approach will be used to identify, evaluate, and synthesize relevant studies reported in English. We have conducted a systematic search focusing on search terms related to sustainable health care, mHealth solutions, and evaluation or assessment criteria in digital databases of Scopus, Web of Science, ACM, PubMed, PubMed Central, and CINAHL. Results: As of September 19, 2024, preliminary searches have been conducted, identifying 1368 relevant papers that meet the inclusion and exclusion criteria and are eligible for further screening. Conclusions: This protocol will guide the review of existing literature on essential aspects of the sustainability of mHealth solutions and evaluation frameworks. To the best of our knowledge, the proposed systematic review will be the first review to extensively study essential concepts related to defining sustainable mHealth solutions, identifying key dimensions founding the basis for evaluation frameworks, and discussing the existing sustainability evaluation frameworks for mHealth solutions. Trial Registration: PROSPERO CRD42024599333; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024599333

Background: A large number of socio-demographic, economic, environmental, and psychosocial changes have contributed to the epidemiological transition of African countries and fundamentally shifted the primary drivers of health. Cohort studies are essential for understanding and improving population health, but remain scarce in sub-Saharan Africa. Objective: The main objective of the Taabo multi-generational cohort project (Taabo MGC) is to establish a large, regionally representative multi-generational cohort. The cohort will be established within the Taabo Health and Demographic Surveillance Site (HDSS) and used for studying the life-course and intergenerational dynamics of disease in south-central Côte d’Ivoire. Methods: The Taabo MGC focuses on children born between January 1, 2024, and December 31, 2025 in the Taabo HDSS, as well as their parents, grandparents and great-grandparents. Eligible women and their children are enrolled during pregnancy and those not reported during pregnancy are enrolled after the birth. After enrollment of pregnant women biological ancestors of the index child who are still alive and living in the study area are recruited into the cohort. The cohort is expected to enroll at least 3’000 pregnant women and their children, as well as the infants’ fathers, grandparents, and great-grandparents with an expected sample size of approximately 15’000 individuals. To ensure the entire local population is covered in this study, we will also include 100 adults without children in the study. The baseline assessments covers data on demographics, household wealth, tobacco and alcohol consumption, diet, physical activity, health history, quality of life, environmental exposures, depression, anxiety, stress, resilience, obstetric history, birth outcomes, cognitive function and physical performance for elders. We also collect anthropometric measurements, blood pressure, hemoglobin levels and conduct a malaria infection test with all participants. Results: We expect this to become one of the largest current cohort studies in Sub-Saharan Africa. Through the HDSS, we will be able to follow all cohort members over time to verify and monitor survival and general health status. Conclusions: The Taabo MGC is designed to become one of the largest cohort studies in the region. We hope to use this study as a platform for future observational and interventional studies at the local level and contribute to the much-needed evidence base on lifetime disease risk in south-central Côte d'Ivoire and sub-Saharan Africa.

Background: Childhood obesity is a lifestyle-oriented disorder, which may lead to many comorbidities such as hypertension, coronary diseases, increased incidence of diabetes, and metabolic syndromes. Lack of diet control and increased screen time specifically after the COVID-19 pandemic among children and adolescents are the major reasons for this rising global concern. Despite various campaigns being carried out to lessen the rising rates of childhood obesity, the objectives have not yet been achieved. Ayurveda offers a multidimensional modality in managing children with overweight. The purpose of this study is to evaluate the combined efficacy of Ayurvedic medicine administration, diet restriction, and Sun Salutation. Navak Guggulu is a herbo-mineral compound already proven for its antiobesity action. Vachaharidradi Gana mentioned in Ayurvedic classics is a group of herbs, which are Kaphamedohara and Karshana. Ayurveda also emphasizes the importance of diet and physical activities for the treatment of obesity. The interventions together may help in promoting a healthy weight, improving metabolism, and reducing fat accumulation. So, in this study, the efficacy of Vachaharidradi Gana Vati will be compared with Navak Guggulu to treat children with overweight in addition to diet restrictions and Sun Salutation. Objective: The aim of the study is to evaluate the efficacy of Navak Guggulu versus Vachaharidradi Gana Vati along with diet restriction and Sun Salutation in overweight (Sthaulya) children. Methods: A double-blind randomized interventional study will be conducted on selected children with overweight in the age group of 10 to 16 years. They will be equally distributed into 2 groups. The control group will be given Navak Guggulu, and the trial group will be given Vachaharidradi Gana Vati for 90 days. Both groups will be advised of diet restrictions and the daily performance of the Sun Salutation. The study duration is 180 days, with assessment at baseline, followed by every 15 days up to 90 days, and at the end point, that is, after 180 days. Appropriate statistical techniques, such as analysis of covariance paired 2-tailed t test, Wilcoxon signed rank test, Mann-Whitney U test, and multivariate regression analysis, will be used to evaluate the efficacy of the interventions. Results: The study got underway in April 2024. Since participants may begin at any time, our goal is for everyone to be finished by May 2025. Conclusions: This research will be useful to provide new insight into the effectiveness of the Ayurveda pharmacological approach in treating obesity in children. The results will guide evidence-based multimodality in treatments aimed at changing lifestyle behaviors in children with obesity, thus reducing social stigmatization in them. Trial Registration: Clinical Trial Registry of India CTRI/2023/03/051135; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzgzNzE=&Enc=&userName=

Background: A majority of nursing home residents do not fulfill physical activity guidelines. Many existing interventions to promote physical activity and prevent falls in nursing home residents have low adherence rates, lack theoretical foundation, or require a large amount of time from staff for preparation and/ or delivery. Objective: To describe the rationale, development steps, and implementation approach of the BeStAge app through a cluster randomized controlled trial (cRCT), as well as to provide baseline characteristics of the study sample and discuss possible implications for further app developments. Methods: We iteratively developed a novel, tablet-based mobile application named BeSt Age app that enables nursing home staff to deliver individualized physical exercise training to residents with or without motor or/ and cognitive impairments. The app was designed and developed based on an intervention-mapping approach. A needs assessment was performed, followed by defining objectives, theory-based methods, program development, implementation, and evaluation. We took several steps to ensure that the app was based on a sound theoretical background, as well as results derived from and limitations identified in prior empirical research. For implementation and evaluation purposes, we conducted a cRCT, and results from the cRCT will be used to examine the effectiveness of the app with regard to different outcomes of interest. Primary outcomes among participating nursing home residents are quality of life, fall risk evaluated through two performance-oriented balance tests, and fall incidence. Secondary outcomes include motor performance, cognition, activities of daily living, life space/ physical activity behavior, and fall efficacy, amongst others. Results: 229 older adults from 19 different nursing homes (171 females, 58 males; mean age 85 years) participated in the cRCT. The intervention group (IG; N = 137 from 11 nursing homes) received a 12-week intervention with the BeSt Age app in small, homogenous groups of 5-7 nursing home residents, with two exercise sessions per week, each lasting 25-30 minutes. The control group (CG; N = 92 from 8 nursing homes) received usual care. At baseline, the IG had a statistically significantly larger number of females, participants had a higher body mass index, and more participants rated attending physical activity programs as important; there were no further statistically significant differences between IG and CG. Results with regard to the effectiveness of the BeSt Age app are expected to be published in summer/ fall of 2025. Conclusions: If proven effective, the BeSt Age app may be a viable solution for physical activity promotion and fall prevention among older adults residing in nursing homes, thereby ultimately contributing to maintaining quality of life and overall well-being in this vulnerable population. The app can support nursing home staff in delivering exercise training to residents with minimal additional workload and without requiring specific resources. Clinical Trial: German National Register of Clinical Trials (DRKS00032349)

Background: Families play a pivotal role in shaping children’s emotional development through emotion socialization. However, most research has focused on individual or dyadic relationships, such as those between parents and children, overlooking the more complex dynamics that emerge when multiple family members interact simultaneously. This limited perspective fails to capture the full scope of the interconnected emotional processes within family units. A contributing factor to this gap is the limited availability of models suited for capturing and analyzing complex, family-level data. Objective: The Family and Child Emotion Study aims to address this gap by examining family-wide emotion dynamics across all family members—including parents and children—as they naturally unfold in daily life. Methods: This protocol uses a pre-post design and a 7-day ecological momentary assessment period combined with ambulatory monitoring of heart rate and electrodermal activity within whole family units to examine interactions among mothers, fathers, and siblings, providing a comprehensive understanding of family-wide emotion processes. Data will be analyzed using a network analytical approach, specifically multilevel vector autoregressive modeling, to investigate dynamic emotional processes within and between family members. Results: Funding was received in April 2020. Data collection began in September 2022 and will continue until March 2026. As of May 2025, the Family and Child Emotion Study has collected data from 48 eligible families. Data analyses will begin after March 2026, with results expected to be published in Fall 2027. Conclusions: This study introduces an innovative approach for examining emotion dynamics within whole-family systems in naturalistic settings, offering practical guidance for collecting and analyzing complex, multilevel, and nested data. The primary aim is to investigate how family emotion networks contribute to children’s emotional functioning and development. A secondary aim is to explore key factors, such as parental psychological functioning and child emotion regulation abilities, that may shape these networks. This protocol serves as a valuable framework for future researchers exploring family-wide emotion dynamics.

Background: Hemolytic transfusion reactions are a major complication in patients with β-thalassemia major receiving regular transfusions. These reactions can be influenced by blood group incompatibilities, particularly in settings with limited genotyping practices. In Indonesia, the role of blood group genotyping in predicting hemolysis has not been thoroughly studied. Objective: This study aims to analyze the association between blood group genotyping and the incidence of hemolysis in people with thalassemia undergoing repeated transfusions. Methods: This is a cross-sectional study involving people with β-thalassemia major younger than 18 years old who received regular transfusion with intervals of 2-4 weeks and have received more than 20 units of transfusion. Participants with leukemia, lymphoproliferative diseases, diabetes, solid tumors, and immunosuppression disorders were excluded from the study. Genotyping examination was conducted using Allele-Specific polymerase chain reaction (PCR ASP) while phenotyping was examined using immunoserology. Follow-up gene sequencing was conducted to observe the blood group variants. Hemolysis was assessed using several markers such as haptoglobin, free hemoglobin, lactate dehydrogenase, bilirubin, and hemoglobinuria, measured by Cobas C113, the enzyme-linked immunosorbent assay, and urinalysis. Results: Clinical and laboratory data collection is completed. A total of 90 samples were collected, data analyses were undertaken, and the initial results were reported in September 2024. Conclusions: The results of this study will provide information on the blood groups’ systems that can predict hemolysis occurrence in patients with β-thalassemia undergoing repeated transfusion. These data will contribute to the best possible patient care management and blood transfusion therapy, thereby reducing the risk of hemolysis and improving the quality of life for patients with thalassemia in Indonesia.

Background: The health and economic burdens of Alzheimer’s disease and related dementias (ADRD) are exacerbated for people living in rural social contexts who experience geographic barriers to care. There are currently few resources specifically designed to support socio-culturally diverse rural ADRD care dyads, including early detection of potential precursors to ADRD such as Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD). Objective: The primary objective of the Northern Arizona Memory Study (NAZMS) is to develop culturally-informed and scalable resources to identify and support rural families at risk for ADRD. The purpose of this study is to introduce the NAZMS protocol and discuss its role in addressing dementia risk and promoting cognitive health in rural communities. Methods: This dyadic study uses a mixed-methods, digital health approach. A sample of rural care dyads with MCI or SCD is screened and recruited through partnerships with community centers across Northern Arizona. Consenting dyads complete semi-structured interviews where they answer questions about technology preferences for monitoring symptoms and engaging in remotely-delivered interventions. Next, care dyads complete separate baseline questionnaires assessing dyadic (e.g., experiences with caregiving/care-receiving) and health factors. Participants with cognitive impairment then complete a 14-day mobile protocol of brief end-of-day surveys and cognitive assessments delivered via study-provided smartphones. Results: Data from the qualitative interviews provide dyad preferences for intervention development. Data from the quantitative protocol specify for whom (i.e., between-person) and on which days (i.e., within-person) modifiable factors are related to better cognitive health in everyday life. Conclusions: This study takes a mixed-methods, digital health approach to supporting rural families at risk for ADRD by understanding intervention preferences and identifying the modifiable protective and risk factors that influence cognitive health in everyday life. The findings will directly support rural Arizonans and respond to national priorities in ADRD research for the development of community-based disease education programs and use of digital assessments of cognitive health and well-being. Clinical Trial: Not Applicable.

Background: Sexual assault (SA) is a serious problem at universities. It is estimated that 1 in 5 women students will experience SA before they graduate. Objective: The primary aim of this randomized controlled trial is to test whether a synchronous web-based facilitated adaptation of an efficacious intervention (the Enhanced Assess, Acknowledge, Act [EAAA] program) can reduce the 1-year incidence of rape among first- and second-year undergraduate women. Secondary aims will assess the impact of the Internet-Delivered EAAA (IDEA3) on other forms of SA (attempted rape, attempted and completed coercion, and nonconsensual sexual contact). Tertiary aims will evaluate effects of the program on (1) survivor self-blame in the event of an assault, (2) 6 known mediators of the intervention effect to guide revision of IDEA3 if necessary, and (3) 2 exploratory outcomes measuring acceptance of sexualized aggression and sexual empowerment. Methods: In this multisite open-label randomized controlled trial, 1920 diverse women students at 2 Canadian and 4 US universities will be randomly assigned to receive either the 12-hour IDEA3 (intervention arm) or standard of care (control arm: 60-minute, web-based, live-facilitated consent workshop). Outcomes are measured at baseline, 1 week, 6 months, and 12 months post intervention. SA will be assessed using the Sexual Experiences Survey-Short Form Version. Survivor self-blame and outcomes known to be mediators of EAAA’s reductions in SA will also be measured. Results: Funding was received in October 2022. Recruitment began on October 2, 2023, and the first participant was randomized on October 23, 2023. As of August 2025, a total of 683 participants have been enrolled and randomized. Data collection will end in May 2027. Conclusions: If efficacious, IDEA3 will be made available to universities in Canada and the United States. To date, 6 provinces in Canada and the Campus SaVE Act in the United States require institutions to provide SA prevention programming. An evidence-based, cost-effective option that can be delivered remotely via the internet has the potential to become the gold standard. The research, therefore, has the potential to impact women’s health and safety internationally. Trial Registration: ClinicalTrials.gov NCT06058455, https://clinicaltrials.gov/study/NCT06058455

Background: Preeclampsia is 1 of the 3 leading causes of maternal mortality worldwide. Unfortunately, its exact pathogenesis is still unclear. Published metabolomic and gene expression analyses point to coenzyme A (CoA) restriction in the placenta as a factor underpinning the observed complications of preeclampsia, but this hypothesis has never been tested. Objective: This pilot study aims to discover evidence supporting the CoA-restriction hypothesis through 2 avenues. The first of these involves developing a procedure for the quantitative determination of metabolites to discover if harmful metabolites are elevated in patients with preeclampsia, while the second seeks to emulate the onset of CoA restriction in cultured cells. Methods: This manuscript provides a rationale and a protocol for a clinical study and laboratory experiments to test the hypothesis. The methods have 3 key aspects. Phase 1 comprises optimization of assays of 5 key metabolites arising from CoA restriction, namely L-leucine, ketoisovalerate, ketodeoxycholate, oleic acid, and sphingosine-1-phosphate. Phase 2 comprises recruitment of patients to obtain serum samples to measure the metabolites, and phase 3 comprises culturing and treating trophoblast cells to induce CoA restriction and test the effects of the metabolites on the cells. Patients with preeclampsia and healthy controls will be recruited based on World Health Organization criteria for preeclampsia. Exclusion criteria include multiple pregnancies, premature rupture of membranes, and various medical complications. Blood samples will be collected and analyzed using high-performance liquid chromatography/mass spectrometry (HPLC/MS) to quantify key metabolites associated with CoA restriction. For trophoblast cell studies, BeWo cells will be cultured under conditions likely to induce CoA restriction, including hypoxia and human chorionic gonadotropin supplementation, and will also be treated with the key metabolites to determine what effect they might have. Cell viability, apoptosis, energy metabolism, and gene expression (focusing on genes involved in CoA synthesis and metabolism) will be assessed. Statistical analysis will involve 2-tailed t tests or Mann-Whitney U tests to compare metabolite concentrations between patients with preeclampsia and controls. A correlation matrix will be used to explore associations between metabolite levels and patient characteristics. Results: Institutional review board ethics approval has been obtained for this study. Patient recruitment started April 1, 2025. The 5 metabolites have been purchased in synthetic form and used to optimize the HPLC/MS assays in preparation for receiving blood samples. The trophoblast cell-line culture is being optimized. Conclusions: The findings of this study will demonstrate that key metabolite concentrations can be quantified using HPLC/MS and indicate if CoA restriction is associated with preeclampsia. If so, this provides a significant, novel avenue for research into the treatment and prevention of the disease.

Background: Older adults with complex care needs and polypharmacy are at risk of experiencing medication-related problems such as administration errors and adverse drug events. These problems lead to increased utilisation of emergency care and hospital admissions. Technology-based interventions have been introduced to address some of these problems. This review aims to establish key concepts and address the gaps in the evidence base to improve the use of technology-based interventions and reduce medication management-associated problems in home care settings. Objective: This scoping review aims to understand the extent and type of evidence regarding the management of medications for older people in home care settings using technology-based interventions. Methods: The review will follow the Joanna Briggs Institute (JBI) methodology. The published studies will be searched through MEDLINE, CINAHL, Scopus, Web of Science, Embase, IEEE Xplore and ACM digital library and the unpublished studies through the EBSCO Open Dissertations database. Studies published in all languages will be considered. A broad scope of evidence, including quantitative, qualitative, text and opinion studies, will be considered. This review will include studies of older adults (aged 60 years or older) living in home care settings and receiving formal or informal social care support for medication management. Studies that focus on the application of the technology for medication management will be included. The titles and abstracts will be reviewed initially for relevance, and then the full text will be reviewed for in-depth analysis. The results of the search and inclusion process will be presented in a Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR)) flow diagram. Data will be extracted from the included studies using a data extraction tool developed for this study. Results: A draft charting table will be developed as a data extraction tool. Results will be presented in a graph, diagram, or table, accompanied by a narrative summary. Conclusions: This review will identify and synthesise evidence associated with applying technology-based medication management interventions to older people in home care settings and the strategies to overcome those identified challenges. This review will identify knowledge gaps, clarify concepts, and make recommendations for future research on technology-based medication management interventions.

Background: Childhood obesity is a serious global health concern that affects around 20% of children worldwide. Digital health behaviour change interventions have the potential to improve behaviours that can contribute to childhood obesity, such as diet and physical activity, but often lack sufficient user engagement to achieve significant impact. Objective: The aim of this project is to develop evidence to better understand how users engage with digital interventions and how Behaviour Change Techniques can be leveraged to support engagement. Specifically, the study will examine the impact of a family-focused app for childhood obesity prevention on health behaviours, health outcomes, and communication between families and healthcare professionals. Methods: A pre-post, mixed-methods evaluation will examine the impact of the NoObesity app on families’ physical activity and dietary behaviours and on healthcare professionals’ self-efficacy at communicating with families about childhood obesity. Secondary outcomes will include well-being, usability, and users’ engagement with and perceptions of the intervention. An initial sample of 1000 families (children and young people of any age and weight and their parents) and 180 healthcare professionals will be recruited to participate in the study, a subset of whom will be invited to qualitative semi-structured interviews. The study implementation and follow-up period will last for 6 months, with the outcomes measured at baseline and 3- and 6-months post-baseline. Quantitative outcomes will be compared over time using repeated-measures ANOVA and qualitative data will be analysed thematically and triangulated with app use data. Results: Ethical approval was received from Newcastle University Faculty of Medical Science Ethics Committee (2688/41816) on 22 March 2024. Recruitment has not yet begun. Conclusions: The project’s key contributions will be to generate evidence of potential for a family-based digital intervention to support families’ health behaviour change and healthcare professionals’ confidence in their ability to support them and to improve our understanding of how particular Behaviour Change Techniques can be used to support engagement with the intervention and its target behaviours. Findings will be disseminated via peer-reviewed journal and to the general public with support from patient and public involvement representatives.

Background: Alcohol consumption remains a major societal problem, contributing to myriad health conditions. Australian midlife women (aged 45-64 years) consume more alcohol than previous generations of midlife women and more than younger women now. Alcohol poses health risks that are unique to midlife women, including increased risk of breast cancer; 10% of breast cancers result from alcohol consumption and there is no “safe” limit. There is a global gap in knowledge about socially and culturally appropriate interventions for reducing alcohol consumption in these heavy-drinking groups of midlife women.

Background: The growing population of cancer survivors faces persistent physical and emotional challenges that significantly impact health-related quality of life (HRQL). To address these multifaceted needs, robust and culturally adapted patient-reported outcome measures, such as the Measure Yourself Concerns and Wellbeing (MYCaW®) questionnaire, are essential for understanding and improving survivors’ subjective experiences. Objective: This protocol outlines the systematic translation and cultural adaptation of the MYCaW® questionnaire into German. The MYCaW® questionnaire, a patient-reported outcome measure, is designed to capture individualized concerns and assess overall well-being, particularly in cancer care settings. By adhering to common guidelines, this research will provide a tool for assessing individualized concerns and patient needs among German-speaking cancer patients. Methods: Following International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines, this study will employ a structured methodology involving forward and backward translation, expert review, patient review process, and preliminary validation to ensure linguistic and cultural equivalence. The present study is approved by the ethics committee of the Medical Association Berlin with the reference number Eth-27/10. Construct validity will be assessed through comparison with the EORTC QLQ-C30 and the MIDOS questionnaire, to evaluate both quality of life and symptom burden. Results: Funding of the study was obatained in January 2023. Patient recruitment started in Q1 2023, and the cognitive debriefing phase is ongoing. Validation with the larger patient sample (n=120) is scheduled to conclude in Q4 2025, with publication of the study results anticipated in Q1 2026. The adaptation process will include translation, expert review, and cognitive debriefing with patients and healthcare professionals to ensure linguistic clarity and cultural relevance. Conclusions: The translation and adaptation of MYCaW® into German will contribute to expanding the availability of validated patient-reported outcome measures for German-speaking populations. By following rigorous international guidelines, this study aims to produce a reliable, culturally appropriate, and linguistically adapted German version of the MYCaW® questionnaire for assessing patient concerns and well-being in oncology and supportive care settings. Future validation studies will be necessary to assess the psychometric properties of the adapted questionnaire and its applicability in clinical and research contexts. Potential challenges, such as maintaining conceptual equivalence in translation and ensuring broad representativeness in the validation process, will be addressed through iterative refinement. Once validated, the German MYCaW® will provide a valuable resource for patient-centered research and care, helping to capture individualized concerns that might be overlooked by standardized instruments. Clinical Trial: German Clinical Trials Register; DRKS00013335; https://drks.de/search/de/trial/DRKS00013335.

Background: Children with acute lymphoblastic leukemia (ALL) undergoing chemotherapy have limited access to rehabilitation support. While rehabilitation on the basis of physiotherapy has been found to enhance psychosocial well-being and motor performance, a viable substitute for this can be aquatherapy. However, no trials have currently evaluated the effectiveness of aquatherapy in this population. Objective: We aim to evaluate the comparative efficacy of aquatherapy versus conventional physiotherapy on the motor function and psychosocial well-being of children with ALL. Methods: We will conduct a parallel, single-blinded (participant-blinded), randomized controlled trial with embedded quantitative analysis. In total, 54 survivors of ALL undergoing chemotherapy will be recruited from the Acharya Vinoba Bhave Rural Hospital in Sawangi (Meghe), Wardha, Maharashtra, India. The experimental group will attend a 4-week, thrice-weekly, 45-minute aquatherapy session focusing on exercise-based rehabilitation. The comparison group will receive conventional physiotherapy including standardized exercises. Assessments will be completed at weeks 0 (baseline), 4 (postintervention), and 12 (follow-up). The primary outcome related to motor function will be measured using the timed up and go test and the Pediatric Balance Scale at week 4. Secondary outcomes will include psychosocial well-being measured with the Hospital Anxiety and Depression Scale and functional abilities measured with the Functional Independence Measure for Children (WeeFIM). Health service data, including length of stay in the hospital, hospital readmissions, and emergency department presentations, will be recorded. Semistructured interviews will be completed within an interpretive description framework to explore participant descriptions. The primary outcome will be analyzed using linear mixed effects models. Results: The trial is scheduled to commence in October 2025. Conclusions: The trial will inform future implementation of rehabilitation for children with ALL by providing important data regarding the efficacy of aquatherapy compared with conventional physiotherapy as well as patient experience. Trial Registration: Clinical Trials Registry - India CTRI/2025/03/083036; https://tinyurl.com/v446cd6z

Background: Integrative nursing (IN) involves the application of external naturopathic nursing interventions, such as compresses, embrocations, and therapeutic baths and washes. As part of a university hospital project, patients receiving oncology care in participating wards receive IN interventions as supportive care during their hospital stay as part of a consultation service. Objective: This study aims to investigate the acceptance, feasibility, and contextual conditions of implementing IN in inpatient care and to evaluate perceptions, experiences, and perceived impact of IN interventions from multiple stakeholder perspectives. Methods: We used a convergent parallel mixed methods approach guided by the Consolidated Framework for Implementation Research. The evaluation consists of 5 substudies reflecting multiple perspectives on the project. Patients, relatives, and hospital staff will participate. Substudies include a single-arm pre-post questionnaire (substudy 1) and semistructured interviews (substudy 2) with patients, a cross-sectional survey of relatives (substudy 3), semistructured interviews with health care professionals (substudy 4), and analysis of project-related documentation (substudy 5). Qualitative data will be analyzed using qualitative content analysis, and quantitative data will be analyzed using descriptive and inferential statistical methods. Results: Following separate analyses of each substudy, the findings will be integrated and triangulated to generate overarching meta-inferences. The recruitment phase lasted from October 2023 to January 2025. Data collection was completed in March 2025. As of October 2025, after data verification and plausibility checks, data analysis is ongoing. The first results are expected to be published in 2026. Conclusions: This study presents a mixed methods research protocol aimed at exploring the implementation of IN within a university hospital setting. It is expected to provide a theory-based contribution to IN implementation in inpatient care while also offering insights into its potential effects at the patient level. The study is anticipated to advance understanding of how IN can be sustainably embedded in hospital practice and to provide actionable insights for improving patient-centered supportive care. Trial Registration: German Clinical Trials Register DRKS00032318; https://drks.de/search/de/trial/DRKS00032318

Background: Hypertension is a significant risk factor for cardiovascular diseases and is associated with an increased risk of mild cognitive impairment (MCI). The lack of effective treatment for these conditions underscores the urgent need for novel therapeutic approaches. Previous studies have indicated that microcirculation serves as the pathological basis for the comorbidity of hypertension and cognitive dysfunction. Our initial clinical studies have indicated that acupuncture could be a safe and effective treatment for managing hypertension and MCI. Whether acupuncture can enhance hypertension and cognitive impairment by modulating microcirculation, and the precise mechanisms involved, warrants further exploration. Objective: The objective of the trial is to evaluate the clinical efficacy of electroacupuncture on MCI of patients with hypertension and to explore whether it can improve hypertension and cognitive impairment by regulating microcirculation. Methods: In this multicenter, large-scale, single-blind, randomized controlled trial, we will recruit 252 patients with hypertension and cognitive impairment from 3 hospitals and randomly assign them to 3 groups in a 1:1:1 ratio: the electroacupuncture group, the sham electroacupuncture (SEA) group, and the waiting list group. The electroacupuncture group and SEA group will receive either electroacupuncture or SEA for 12 weeks, while the waiting list group will not receive acupuncture treatment for the first 12 weeks. The primary outcome will be the changes in overall cognitive function, as measured by the Montreal Cognitive Assessment. The secondary outcomes include blood pressure status, subdomain cognitive function, mental status, sleep quality, hemodynamics, and microcirculation indicators. Results: The study protocol has been approved by the institutional review board of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine. This study was registered on April 26, 2024, with the Chinese Clinical Trial Registry. Data collection began in May 2024 and ended in April 2025. Currently, data from this trial are in the collection phase, and no data analysis has been performed. As of January 1, 2025, we have collected data from 65 patients. The results of this trial are expected to be submitted for publication in July 2026. Conclusions: This clinical trial aims to compare the efficacy of electroacupuncture versus SEA or waiting list control in the treatment of hypertension with cognitive impairment and to explore its impact on microcirculation through hemodynamic and microcirculatory indices. The results of this trial will contribute to clarifying the microcirculatory mechanisms of electroacupuncture in the treatment of hypertension with cognitive impairment, providing a solid foundation for further research on electroacupuncture therapy. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2400083501; https://www.chictr.org.cn/showproj.html?proj=220722

Background: Women and girls around the world face significant barriers in participating in health care decisions, particularly in low- and middle-income countries. Despite growing interest in shared decision-making (SDM), little is known about its implementation in these countries, and no rigorous assessment of the decision-making needs of women and girls in these contexts has been conducted. There is little SDM training and there are few decision-support tools (DSTs) specifically designed for health care decision-making by women and girls in these countries. DSTs (paper or digital) present options and probabilities and help users articulate their values and preferences. Objective: We aim to codevelop an SDM resource platform, including locally relevant DSTs and instructional materials, to support SDM with women and girls in Brazil, Cameroon, and Senegal. Methods: We will conduct a 4-phase participatory research project. We will use the Gender-Based Analysis Plus tool to support inclusive participatory research throughout the study. First, we will follow the Integrated Knowledge Translation framework to form a local steering committee in each country, including patients and community representatives, health and social service professionals, and decision-makers. Second, we will follow the Ottawa Decision Support Framework to conduct individual interviews and focus groups to identify the decision-making needs of women and girls. We will include 20 women and girls, along with their family members, 15 health and social service professionals, and 15 representatives of community-based organizations in each country (n=150). The Double Diamond human-centered design framework will be used to codevelop a digital SDM resource platform where DSTs and instructional materials for SDM training can be made accessible. Finally, we will assess the scalability of the platform by using the Innovation Scalability Self-Administered Questionnaire. We will report our study by using the Standards for Reporting Qualitative Research guideline and the Guidance for Reporting Involvement of Patients and the Public. Results: Financial support for this project was received on February 1, 2023. This protocol was submitted during data collection but before analysis. Data collection began in January 2025. By July 2025, 92 of the 150 participants had been recruited. We expect to publish our results in December 2026. Conclusions: Ultimately, more women and girls from low- and middle-income countries will be involved in health care decisions, and more clinical teams will be able to integrate SDM into their care practices. The local steering committees will ensure equitable partnerships and the SDM resource platform will promote more inclusive approaches to SDM worldwide. The scalability assessment will help us plan to expand the impact of the platform to other regions. Trial Registration:

The present study replicated and extended prior research by comparing the effects of reviewing notes in groups vs. reviewing notes individually on individual final test performance. We also examined the potential interaction between reviewing delay and reviewing methods. Finally, students completed a questionnaire, the results of which reveal how students perceive the effectiveness of group vs. individual reviewing methods. In this experiment, students watched and took notes on two lectures. Following a short or long delay, students reviewed their notes either individually or in a group and were allowed to update their notes during these sessions. After the reviewing phase, students completed a final test for each lecture. We found that individuals added more idea units to their notes after reviewing notes in a group, and this beneficial effect was greater after a longer delay compared to a shorter delay. However, more new idea units did not translate into better cued recall performance. Our findings suggest that reviewing notes in a group helps individuals add more overlooked idea units in their notes, but more factors should be considered when studying the relationship between reviewing notes in a group and final test performance.

Background: Over 30% of people in the United Kingdom are living with a long-term physical health condition. Early preventative peer support interventions could improve the lives and psychosocial well-being of people with long-term physical health conditions and reduce progression of any symptoms of low mood to more significant depression. In partnership with people with long-term conditions and industry stakeholders, we have co-designed an online peer support platform, CommonGround, to help people with long-term health conditions connect, support others, share experiences, and receive evidence-based information and advice on self-management. Objective: This feasibility randomized controlled trial will investigate whether the CommonGround platform is usable and acceptable for people with long-term physical health conditions experiencing mild depressive symptoms and whether conducting a future, larger confirmatory randomized controlled trial is feasible. Methods: A mixed methods, 2-arm, parallel-group, unblinded randomized controlled feasibility trial will be conducted nationally across the United Kingdom. Participants will include 150 adults (aged ≥18 years) who have access to the internet and are living with at least one long-term physical health condition and subthreshold depression (scoring 5-9 on the Patient Health Questionnaire–8). Following baseline assessments, eligible participants will be randomized to a coproduced online peer support and psychoeducation platform or a control condition where participants will receive fortnightly emails containing links to the National Health Service mental health web pages. Assessment measures will be collected at baseline and the midintervention (6 weeks) and postintervention (12 weeks) time points. A purposive sample of approximately 40 participants will be interviewed after the intervention to evaluate participant experiences and views on acceptability. The primary feasibility outcome is the number of participants recruited to the trial per week and in total via each recruitment route (as self-reported by participants). Results: Recruitment for the feasibility trial began on February 12, 2024. Quantitative data collection was completed by October 23, 2024, and qualitative data collection was completed by December 3, 2024. Conclusions: This trial will explore the acceptability and feasibility of our coproduced online peer support platform with embedded psychoeducational resources targeted for people living with long-term physical health conditions and subthreshold depression who are at risk of developing major depressive disorder. The findings will inform the future design of a larger randomized controlled trial exploring the platform’s clinical efficacy and cost-effectiveness.

Background: Continuous monitoring of patients’ vital signs is critical for early detection of postoperative complications. Traditional manual monitoring by nursing staff is time-consuming and provides only intermittent data. Wearable devices offer continuous monitoring capabilities, potentially enhancing early warning systems, reducing nurse workload, and facilitating earlier patient discharge. However, research on their implementation and effectiveness in clinical settings remains limited. Objective: This study aims to evaluate the implementation and feasibility of continuous monitoring using photoplethysmography sensor technology (a viQtor device) in a surgical ward. We will also assess the impact on nursing workload and the usability of this workflow. Methods: The REQUEST (Remote Monitoring by viQtor Upon Implementation on a Surgical Department) study is a prospective observational implementation study conducted over 8 months in a surgical ward. The vital signs of 500 postoperative patients will be continuously monitored using the viQtor device, which measures heart rate, respiratory rate, and oxygen saturation. The study consists of 2 phases: an initial period with manual spot checks, followed by a phase using the wearable device as the primary monitoring tool. Outcomes include the Integrated Workload Scale for nursing workload and a framework evaluating acceptability, feasibility, adoption, and sustainability. Data collection involves device performance metrics, questionnaires (the Evidence-Based Practice Attitude Scale and the System Usability Scale), and thematic analysis of focus groups. Results: Staff training was completed in October 2024, and full implementation is ongoing. Preliminary findings, including data on usability and workload, are expected by July 2025. Conclusions: This study will provide insight into the practical implementation of continuous vital sign monitoring in surgical care. The findings may support future adoption of wearable technology in clinical workflows. Trial Registration: ClinicalTrials.gov NCT06574867; https://clinicaltrials.gov/study/NCT06574867

Background: In the United States, transgender men and transmasculine people who have sex with men (TMSM) face an increased risk of HIV and encounter unique barriers to HIV prevention services, including preexposure prophylaxis (PrEP). Peer-based, digitally delivered support interventions that address these barriers in 1-on-1 or small-group settings may be effective in increasing PrEP engagement. Objective: This study aims to compare the efficacy of digitally delivered individual and small-group peer-based strategies for improving PrEP uptake and adherence among at-risk adult TMSM without HIV. Methods: The Transmasculine One-on-One and Group Empowerment for Targeted HIV Reduction (TOGETHR) study was a digital, open-label, randomized 2×2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies designed to increase PrEP engagement in 300 PrEP-indicated TMSM without HIV. Participants were randomized to 1 of 4 conditions: (A) standard of care (SOC) package (information and PrEP locator tools), (B) SOC + PrEP for TMSM (PrEP4T; individual peer-based HIV prevention intervention), (C) SOC + LifeSkills for TMSM (LS4TM; group peer-based HIV prevention intervention), or (D) SOC + PrEP4T and LS4TM (both individual and group interventions). Interventions were delivered over a 6-week period. The study enrolled adults 18 years or older who were “transgender men or transmasculine,” sexually active with 1 or more partners who had a penis and were assigned male sex at birth, living without HIV, behaviorally at risk for HIV acquisition, and residing in geographic hot spots identified in the US Ending the HIV Epidemic initiative. Results: Study protocols and procedures were codeveloped with our community advisory board, including eligibility criteria, operationalization of geographic stratification, study branding, and detailed recruitment plans. Recruitment and enrollment began on April 1, 2024, and as of March 20, 2025, 103 TMSM had been enrolled. The median age was 26 (IQR 24-31) years. Among the 103 participants, 39 (37.9%) identified as Black, Indigenous, and People of Color, and 18 (17.5%) as Latine; 36 (35.0%) identified as “transgender man or trans man”; 31 (30.1%) as transmasculine; and 15 (14.6%) as nonbinary, genderqueer, or gender nonconforming. Additionally, 69 (67.0%) had at least a four-year college degree, and only 7 (6.8%) had no health insurance. Granger causality tests indicated that recruitment activities via social media (P=.006) and transgender-inclusive dating platforms (P=.02) were most effective and predicted higher baseline enrollment survey completion 2 weeks later. On March 21, 2025, the National Institutes of Health terminated the grant award, citing gender ideology and stating, “it is the policy of NIH not to prioritize such research programs.” Conclusions: This study was part of a critical research pathway to identify effective strategies for preventing HIV acquisition in TMSM, a group traditionally underserved in HIV prevention, and to inform prevention packages that incorporate peer-delivered interventions. Strong engagement with the TMSM community was central to the study’s success and provided valuable insights for future HIV prevention research and practice. Trial Registration: ClinicalTrials.gov NCT06182280; https://clinicaltrials.gov/ct2/show/NCT06182280

Background: Atopic dermatitis (AD) is a recurrent, inflammatory, and chronic skin disease that influences over 200 million individuals around the world and is viewed as an important health problem due to its elevated prevalence, long course of disease, and heavy disease burden. WuSheZhiYang (WSZY) pills are composed of 11 Chinese herbs and have the effects of nourishing the blood, drying dampness, and relieving itching. In clinical practice, WSZY pills are recommended for itching skin diseases, but high-quality clinical trial evidence is still limited. Objective: In this study, we will implement a double-blind, randomized, placebo-controlled trial to evaluate the efficacy of WSZY pills for mild-to-moderate AD. We hypothesized that WSZY pills can effectively alleviate the disease condition of patients with mild-to-moderate AD. Methods: In this study, we will recruit 60 patients with mild-to-moderate in Shanghai Skin Diseases Hospital from December 2024 through December 2025. In this study, 60 male and female patients with AD aged 18 years to 65 years will be randomly assigned (2:1) to the treatment group (urea ointment and WSZY pills; n=40) or control group (urea ointment and placebo WSZY pills; n=20), and both groups will receive 4 weeks of treatment and 4 weeks of follow-up. The treatment group will receive 3 sessions of urea ointment and 7.5 g of WSZY pills each day for 4 weeks, and the control group will also receive 3 sessions of urea ointment and 7.5 g of placebo WSZY pills each day for 4 weeks. The primary indicator is the change in the objective Scoring Atopic Dermatitis (SCORAD) score between baseline and week 4. The secondary indicators include SCORAD at week 2 and week 8; Peak Pruritus Numerical Rating Scale (PP-NRS), Investigator's Global Assessment (IGA), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI) at week 2, week 4, and week 8; and the proportion of participants receiving remedial treatment, amount of levocetirizine tablets used, and recurrence rate at week 8. In this study, we will analyze the full analysis set and per-protocol set using SAS software version 9.4, and a 2-tailed alpha level of .05 will be viewed as statistically significant. Results: The study received ethics permission in September 2024, and trial registration was completed in October 2024. Recruitment started in December 2024 and is expected to be completed by December 2025. As of June 2025, 30 participants with mild-to-moderate AD were enrolled. Data analysis will begin in January 2026. The main results of the trial are expected to be submitted for publication in peer-reviewed scientific journals in the summer of 2026. Conclusions: This study will evaluate the efficacy of WSZY pills for AD and provide additional evidence, suggest new therapeutic options for patients, and reduce their disease burden. Clinical Trial: International Traditional Medicine Clinical Trial Registry ITMCTR2024000724; http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=bda070f8-a733-4f52-87b0-39e4be57ac00

Background: Children and youth with medical complexities have chronic conditions, functional limitations, and extensive care needs requiring significant family involvement and frequent health service use. Pediatric medicine has improved their life expectancy, shifting care from acute to home settings. In Ontario, home care is publicly funded and includes nursing, therapy, personal support, and allied health services. However, families continue providing the bulk of care, often at great personal costs. As care complexity increases, so does the reliance on home care providers. Yet, many providers report feeling unprepared due to insufficient pediatric training, lack of supervision, and system-level gaps. Here we applied Weiner’s theory of organizational readiness for change, framing readiness as a shared psychological state involving commitment to and confidence in delivering change, thus helping conceptualize provider readiness as encompassing individual competence, contextual supports, and motivational factors. Despite its importance, provider readiness in pediatric home care remains poorly understood. Objective: We examine how home care providers perceive their readiness to care for children and youth with medical complexities, factors influencing readiness, and strategies proposed to enhance their capacity to deliver safe, coordinated, developmentally appropriate home care. Methods: This scoping review follows the updated Joanna Briggs Institute scoping review methodology and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Articles focusing on (1) children and youth with medical complexities aged 0-18 years receiving home care and (2) with at least one chronic medical condition, and (3) paid home care providers will be searched on MEDLINE, CINAHL, Scopus, ProQuest Nursing & Allied Health, PsycINFO, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. Gray literature will be searched on Google Scholar and ProQuest (Dissertations & Theses). A 2-stage screening process will be conducted in Covidence, involving title and abstract screening and full-text review by 2 independent reviewers. Data will be extracted using predefined charting categories and analyzed using both qualitative and quantitative approaches. Results: As of May 2025, screening is underway. The review will map key themes across provider types, care settings, and training contexts and identify factors influencing provider readiness including access to training, system navigation supports, and workplace role clarity and chart recommendations or strategies to enhance readiness. Gaps in pediatric-specific competencies and workforce preparation may also emerge. Conclusions: This review will synthesize current evidence on provider readiness in pediatric home care, identifying strengths, challenges, and development areas. Findings will inform provider training, workforce development, and policy strategies to ensure children and youth with medical complexities receive safe, coordinated, effective home care. A deeper understanding of provider readiness will support more sustainable home care systems and improve outcomes for children and youth with medical complexities and their families. Clinical Trial: OSF Registries 10.17605/OSF.IO/N4FAJ; https://osf.io/n4faj

Background: African American men are at a higher risk for serious health conditions such as cardiovascular disease, diabetes, and stroke compared to non-Hispanic White men. Physical activity (PA) is a modifiable health behavior that has been shown to decrease chronic disease risk; yet, PA engagement is alarmingly low in African American men. Interventions to improve PA engagement are effective in a number of populations; however, very few have been tailored to the unique needs of African American men. Even fewer have leveraged mobile health apps, despite African American men’s interest in and willingness to use such technologies for health improvement. Objective: This comparative effectiveness trial aims to evaluate MobileMen, a PA promotion app tailored to the needs and preferences of African American men. This trial will compare the MobileMen app to a commercially available PA promotion app with similar features but lacks culturally tailored components. Methods: We will recruit a sample of “low active” (accumulating <7500 steps per day) African American men (n=100) aged >30 years from Baton Rouge, Louisiana, and the surrounding communities. All participants are given a Fitbit Charge 6 wearable activity tracker to assess daily PA and steps and are randomized to either the MobileMen intervention app or the comparator app, which is a commercially available PA tracking app called Stridekick. The Stridekick app has features similar to those in the MobileMen app but was not intentionally designed for African American men. The intervention period is 6 months during which participants will interact with their assigned mobile app. MobileMen includes features such as digital badges earned for PA; tangible prizes like exercise equipment; challenges among participants; goal setting; nutrition; PA; and behavior change educational information in text, audio, and video formats. Participants will complete assessments at baseline and at 6 months post randomization. Assessments include objective measurements of daily steps and minutes of moderate to vigorous PA, quality of life, dietary measures, self-efficacy for fruit and vegetable consumption and PA, and autonomous motivation for PA. Results: This trial is in the start-up phase. The MobileMen app development and usability testing was completed in August 2024. Participant recruitment efforts began in October 2024. The trial and associated data analyses and interpretation are planned to be completed by fall 2025. Conclusions: Mobile apps are a widely accessible means to disseminate culturally tailored PA promotion interventions to various populations, including African American men. MobileMen has the potential to impact PA engagement in African American men, which would dramatically improve the overall health and chronic disease risk in this underrepresented group. Trial Registration: ClinicalTrials.gov NCT05621044; https://clinicaltrials.gov/study/NCT05621044

Background: Emotional resilience is a dynamic process by which individuals may prevent, overcome, and thrive following challenging events. Emotional resilience can be defined as absence of negative outcomes (ie, symptoms of psychopathology) and/or the presence of adaptive outcomes (ie, well-being). Despite the wealth of research tracking the nature of and contributions to emotional resilience in adolescence and adulthood, there is a dearth of evidence on the nature of resilience and its development during preadolescent childhood despite this being an important preventative period for later mental health difficulties and a period when emotional experiences change. Objective: Our primary study objectives are 3-fold: to explore how preadolescent children growing up in deprived areas of London may operationalize resilience, evaluate whether there are differences in the development or trajectories of resilience among our target population, and understand what contributes to resilience pathways over time. Additionally, our research aims to better understand the psychometric properties of resilience measures used in a preadolescent sample and assess the feasibility of developing a longitudinal cohort study of preadolescent children in East London. Methods: We will conduct an accelerated longitudinal cohort study in primary schools across the broad geographical area of East London. The multimethod approach will span across 3 data collection arms: (1) child cognitive tasks and psychometric questionnaires in classroom settings, (2) teacher ratings, including teacher assessments of school mental health provisions, and (3) parent questionnaires. We aim to recruit approximately 1200 children aged 7-11 years at baseline across UK school years 3, 4, and 5. Our measures will span themes of resilience and mental health, as well as personal, social, and community resources available to the children. We will collect quantitative data via questionnaires from children, their parents, and school staff. We will collect qualitative data from the children through paper-based tasks. Results: Study recruitment commenced in October 2022 and continued till December 2023. Baseline testing commenced in October 2022 and continued till December 2023; 873 students were enrolled at baseline. Follow-up is anticipated to continue at least annually until June 2027. Conclusions: This study will assess the feasibility of conducting a longitudinal cohort study on preadolescent children in East London. Alongside evaluating the psychometric properties of resilience measures used in this age group, this study will explore how resilience develops in children across time and relate this to other outcome measures. By identifying how personal, social, and community resources may affect resilience in preadolescent children, we will enhance the understanding of how emotional resilience develops in preadolescent children, and future studies will be able to develop interventions to boost resilience by targeting young and diverse populations. Trial Registration: ISRCTN ISRCTN12430839; https://www.isrctn.com/ISRCTN12430839

Background: Nasopharyngeal carcinoma (NPC) is the fourth-most-prevalent cancer in both Indonesia and Asia. Globally, an estimated 133,354 cases and 80,008 deaths were attributed to NPC in 2020. Early diagnosis plays a key role in managing NPC. Molecules found in bodily fluids, such as saliva, contain compounds (including microRNAs [miRNAs]) that can aid in detecting diseases like NPC. More studies on the expression, role, use, and accuracy of salivary miRNAs as potential diagnostic biomarkers of NPC are needed. Objective: This protocol provides a framework for conducting a scoping review aimed at mapping the expression, role, use, and diagnostic accuracy of specific salivary miRNAs as potential diagnostic biomarkers of NPC. Methods: The guidelines established by the JBI will be followed, which include defining the research questions, identifying relevant studies, and selecting studies based on titles and abstracts. The process will involve charting the data; collating, summarizing, and reporting the findings; and consultation. The synthesis will specifically examine the expression, role, use and accuracy of salivary miRNAs as potential diagnostic biomarkers of NPC. Both quantitative and qualitative analyses will be performed. Results: The selection of studies based on keywords was completed in August 2024, and the study screening and review processes were finished by November 2024. The drafting of the scoping review manuscript is currently underway. The development of this scoping review protocol was supported by funding from the Centre for Higher Education Funding and the Indonesia Endowment Fund for Education. Conclusions: The findings of this study will offer a comprehensive overview of the expression, role, use, and diagnostic accuracy of salivary miRNAs as potential diagnostic biomarkers of NPC. The findings of this review are expected to serve as a basis for further research. Clinical Trial: Open Science Framework k3prh_v1; https://osf.io/preprints/osf/k3prh_v1

Background: Depression and generalized anxiety disorder (GAD) are widespread mental health diseases with significant individual and societal consequences. Psychotherapy, particularly cognitive behavioral therapy (CBT), is a common treatment approach, but its application is limited due to costs and staff shortages. Germany has been the first country to integrate and reimburse digital health applications (DiGAs) as an easily accessible treatment option since 2020. Despite regulatory processes, skepticism among physicians regarding clinical relevance and evidence persists. Objective: This protocol aims to describe the methodology of the planned systematic review. Using expert ratings, the app review will assess the guideline conformity, functions, and usability of German DiGAs for depression and GAD listed at the Federal Institute for Drugs and Medical Devices (BfArM). The additional systematic review will synthesize the effectiveness and quality of these DiGAs based on randomized controlled trials. Methods: The study protocol follows the 2015 PRISMA (Preferred Reporting Items for Systematic Reviews) guideline and was registered in the international Prospective Register of Systematic Reviews (PROSPERO). The review consists of 2 parts: (1) a systematic health app review of DiGAs addressing depression or GAD and (2) a systematic review of published evidence on these DiGAs. The systematic health app review comprises a summary of the DiGA features including the Institute for Healthcare Informatics (IMS) App Functionality Scoring System, a guideline conformity check, and the Mobile Application Rating Scale (MARS) assessment. The systematic review of published evidence is based on a systematic literature search in electronic databases (MEDLINE via PubMed, Cochrane Central Register of Controlled Trials [CENTRAL], Web of Science), as well as relevant websites. The approach includes an effectiveness evaluation, a risk of bias assessment using the Cochrane tool, Risk of Bias 2 (RoB2), and an overall quality evaluation using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method. Results: The systematic literature search was conducted in July 2024 and August 2024, and an updated search is planned for November 2025. Data extraction, narrative synthesis, and evaluation of DiGA and corresponding studies are expected to be completed in spring 2026. The results will be presented using a PRISMA flow diagram and tables to display general information, risk of bias, and overall quality. Conclusions: The review will influence both the actual use and future developments of DiGAs. Good quality characteristics will enhance transparency and trust among physicians, while quality deficits provide options for improvement by manufacturers and governing institutions. Consequently, patients’ care with DiGAs may improve. Trial Registration: PROSPERO CRD42024557629; crd.york.ac.uk/PROSPERO/display_record.php?RecordID=557629