Background: The transition to parenthood requires adjustments to new norms and expectations. While there is significant focus on the parenting transition for birthing parents (persons with a uterus), nonbirthing parents (parents who do not give birth, including fathers, gender-diverse parents, adoptive parents, or nongestational coparents) are less supported. Preventive education via SMS text messaging can fill a health service gap and provide timely, standardized, evidence-based information. The Essential Coaching Postpartum program includes 6 weeks of evidence-based daily SMS text messages on topics such as infant care, normal development, parental mental health, and self-care, with streams designed for birthing parents (Essential Coaching for Every Mother) and nonbirthing parents (Essential Coaching for Every Partner).

Background: Black individuals are more likely to die from colorectal cancer (CRC) and experience more treatment-related side effects compared to White individuals. Physical activity (PA) has been associated with decreased side effects, improved CRC treatment completion rates and responses, and survival. However, Black survivors of CRC are 60% less likely to engage in PA than White survivors. The Physical Activity Centers Empowerment (PACE) study is testing an intervention specifically designed to increase PA among Black individuals diagnosed with CRC.

Background: Communication failures in inpatient maternity care are one of the leading causes of preventable maternal mortality. Most maternal mortality occurs during the postpartum period after hospital discharge. Nurses provide most direct inpatient maternity care and are responsible for postpartum discharge teaching, which is a critical moment for communicating about the care plan, concerns, warning signs, and follow-up plans to the patient, who will likely not be seen by a health care practitioner for 6 weeks, if at all. Objective: The purpose of this study is to develop a deeper understanding of communication practices between nurses and first-time mothers during postpartum discharge teaching, including what supports or hinders the transfer of critical information and recommendations for improvement from the nurses and patients themselves. A secondary objective is to assess the acceptability, feasibility, and appropriateness of video-reflexive ethnography (VRE) as an intervention to improve care quality and processes. Methods: We are using a health equity–informed mixed methods study design to develop a deeper understanding of communication practices between nurses and patients during postpartum discharge teaching for first-time mothers, including determinants for optimal communication and recommendations for improvement. Qualitative data will come from VRE, which will take place in 3 rounds: round 1 comprises video recording of actual postpartum discharge teaching, round 2 comprises independent review of the recording by both nurses and mothers, and round 3 comprises group reflexivity sessions with nurse participants. The planned analyses include a qualitative descriptive analysis of the video recordings and qualitative content analyses of the transcripts of the independent review and group reflexivity sessions. Quantitative data will come from a survey of nurse respondents regarding the feasibility, acceptability, and appropriateness of using VRE to reflect on and improve their practice. Survey results and reflections on VRE from round 3 will be integrated into a joint display. Results: This project was funded in 2023 and approved by the Institutional Review Board of the University of Pennsylvania on December 6, 2023. Data collection will take place from 2024 to 2025. Results are expected to be published in 2026. Conclusions: Our work aims to engage with nurses and first-time mothers to identify opportunities to improve postpartum discharge teaching and communication. Secondarily, we plan to find out whether study participants find VRE feasible, acceptable, and appropriate for improving the quality of care and health care communication.

Background: Cardiometabolic diseases, such as cardiovascular diseases (CVD) and diabetes mellitus (DM), represent a global health issue, causing significant premature mortality and disability. Blue-collar workers, who often face a higher exposure to risk factors (eg, smoking, poor diet, and lack of physical activity), are particularly vulnerable to these diseases. Workplace health promotion plays a crucial role in mitigating this risk, yet the scope and the characteristics of interventions targeting this specific workforce remain unclear. Objective: The objective of this scoping review will be to assess the extent and characteristics of workplace health promotion interventions aimed at preventing cardiometabolic diseases and their risk factors in blue-collar workers. Methods: The review will follow the JBI methodology for scoping reviews. A search of MEDLINE, Scopus, Embase, and the Cochrane Database as well as grey literature will be conducted. The search strategy is designed to capture relevant studies published since 2014 in English, Spanish, Italian, and Polish. Eligible study designs include experimental design (eg, randomized controlled trials), observational studies (eg, longitudinal studies), qualitative research, and mixed-method approaches as well as other formats present in grey literature (eg, reports). This review will include studies focusing on health promotion interventions involving adult blue-collar workers (aged ≥18 years) currently employed, with at least 60% of participants being blue-collar employees. The interventions of interest are workplace health promotion strategies targeting CVD, DM, or their risk factors, such as hypertension, obesity, and smoking. Each paper retrieved will be screened for inclusion by at least 2 reviewers. Disagreements between the reviewers will be resolved through discussion with the other reviewers. Studies focusing on noninterventional contexts, mental health, or ergonomic safety will be excluded. Data will be extracted and analyzed using qualitative and quantitative methods, with a focus on intervention types, participant characteristics, and outcomes. Results: The study began in March 2024 and the full scoping review report is expected to be ready in September 2025. Conclusions: The scoping review presented in this protocol can contribute to filling the knowledge gap by mapping the current state of workplace health promotion interventions aimed at preventing CVD and DM and modifying relevant risk factors in the blue-collar workers’ group.

Background: Aggression and violence are prevalent in forensic psychiatric inpatient care. These behaviours significantly impact treatment outcomes, work environments for staff, and strain relationships among patients and caregivers. Managing such behaviours poses a formidable challenge that necessitates innovative approaches and evidence-based interventions. The Therapeutic Meeting with Aggression (TERMA) intervention consists of an eight-session staff training program designed to equip staff with strategies to de-escalate patient aggression thus reducing violence and increase patients’ and staffs’ perceived safety. Objective: The aim of this project is to evaluate the violence prevention model TERMA regarding perceived safety by patients and staff and adverse events within forensic psychiatric inpatient care. Additionally, the project will investigate whether the organisational culture affect the implementation of the TERMA model. Methods: The project includes an observational study with a before and after design. Implementation of TERMA consists of an eight-seminar staff training program. Data sources include questionnaires, medical records, and registries. Quantitative data will be analysed with descriptive and comparative statistics. To analyse changes between the measurements, the plan is to use dependent sample t-tests or Wilcoxon-Signed Rank, depending on if data is normally distributed or not. The project will also include qualitative interview studies, which will be analysed using qualitative inductive content analysis. Results: Participant enrollment began in July 2023 and was concluded by the end of 2024. Data collection and analysis of quantitative data are expected to be completed by early 2026, after which the study findings will be submitted for publication in peer-reviewed scientific journals. Collection of qualitative data is scheduled for second half of 2025 and 2026. Conclusions: This study can add valuable knowledge about the effects of violence prevention model TERMA. Clinical Trial: Trial registration number: NCT05932108 International Registered Report Identifier (IRRID): DERR1-10.2196/74295

Background: Black children and youth disproportionately experience systemic discrimination, racism, stereotypes, and academic streaming, which negatively affect their well-being. Although they often demonstrate high aspirations and resilience, dominant narratives remain deficit-based, emphasizing challenges over strengths. The limited research on resilience among Black children and youth in Canada restricts the development of informed policy and future scholarship. Objective: This scoping review aims to identify, describe, and synthesize existing evidence on the facilitators of and barriers to resilience among Black children and youth in Canada and the United States. Given the shared histories of anti-Black racism and similarly structured systems, such as education, health care, and child welfare, the scope of this study extends to the United States to offer relevant insights that can help inform policy, practice, and future research in both contexts. Methods: This review will be guided by a methodological framework for scoping reviews proposed by Arksey and O’Malley and advanced by Levac and colleagues. We searched 4 multidisciplinary electronic databases (CINAHL, Ovid MEDLINE, ERIC, and PsycINFO) for relevant reports. The Thesis and ProQuest Dissertations and Theses Global database will also be searched for unpublished student theses and dissertations. Two independent researchers will complete the screening process. Using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, the findings will be synthesized quantitatively and qualitatively through thematic analysis. Results: Data screening is ongoing and will be followed by data extraction, analysis, and the drafting of the final manuscript for peer-reviewed publication. Conclusions: This scoping review will generate critical insights into the multifaceted factors that support or hinder resilience among Black children and youth in Canada and the United States. By centering intersectionality and community-engaged approaches, the findings will inform equity-oriented policies, culturally responsive practices, and future research that amplifies the strengths of Black young people. Ultimately, this scoping review will contribute to disrupting systemic inequities and supporting the flourishing of Black children and youth across diverse contexts. Trial Registration:

Background: Childhood obesity frequently persists into adulthood and is associated with an increased risk and earlier onset of cardiovascular disease in later life. Behavioral change strategies have been proposed as the first-line weight management approach for children and adolescents with obesity. Nonpharmacological interventions, such as traditional Chinese medicine (TCM) auricular acupressure treatment and intermittent low-carbohydrate diet (ILCD), are increasingly being investigated in the young obese population. However, there is limited high-quality evidence about effectiveness and safety in weight control and reducing cardiometabolic risk in the pediatric population. Objective: This study aimed to compare the effect of cardiometabolic risk reduction between TCM auricular acupressure treatment (TAAT) and ILCD in children with overweight or obesity with gastric-heat and dampness-obstruction syndrome. Methods: This is a randomized controlled trial. Eligible participants are children with overweight or obesity and enrolled at the obesity clinic of the department of TCM at a tertiary children’s hospital. Eligible participants must meet the following criteria: (1) be aged between 6 and 18 years, (2) be overweight, and (3) have gastric-heat and dampness-obstruction syndrome. Recruited children will be randomized 3:1 to receive either TAAT or a self-administered ILCD for 1 month: 150 in the TAAT group and 50 in the ILCD group. The primary outcome is the change in body weight from the beginning of treatment to the end of 1 month. Secondary outcomes included body weight, waist circumference, waist-to-height ratio, BMI, blood pressure, body fat content, indexes of liver and renal function, indexes of glucose metabolism, gut microbiota, and TCM syndrome scores at the end of 1 month and 3 months, respectively. Primary statistical analyses were conducted using the intention-to-treat strategy. A generalized linear model was used to compare the difference in weight change between the groups, with the baseline body weight as the covariate, to obtain the estimate of the mean difference in body weight change and its 95% CI, using Gaussian for family function and identity for link function. Results: The study protocol was approved by the institutional ethical committee and registered on ClinicalTrials.gov on May 5, 2023, before recruitment. Recruitment began in June 2023 and is expected to be completed by December 2025. As of November 2024, we have enrolled 112 participants. Conclusions: This randomized controlled trial will provide evidence on the treatment effects and safety of TAAT versus ILCD among children with overweight or obesity with gastric-heat and dampness-obstruction syndrome, in reducing body weight and improving cardiometabolic risks. Exploratory aims include potential underlying mechanisms of the 2 kinds of interventions, based on biosamples. Trial Registration: ClinicalTrials.gov NCT05847478. https://clinicaltrials.gov/study/NCT05847478

Background: Colles fracture, a common wrist injury, often requires surgical intervention. After surgery, patients may experience persistent pain and reduced wrist function, potentially resulting in long-term disability. In clinical practice, traditional Chinese medicine practitioners frequently use Ru-Yi-Jin-Huang-Saan (RYJHS) to treat such patients in Taiwan. RYJHS is a traditional Chinese herbal formula with a history spanning centuries, primarily used topically for the treatment of bone fractures and the promotion of healing. However, there is currently a lack of substantial clinical evidence supporting its efficacy in the management of postsurgical Colles fractures. To the best of our knowledge, there are no studies evaluating the clinical effectiveness of RYJHS. Objective: This study aims to investigate the therapeutic potential of RYJHS in postsurgical Colles fracture cases. An additional objective is to provide an alternative treatment option for postoperative patients unable to take anti-inflammatory and pain relief medications. Methods: This is a protocol for a randomized, double-blind, placebo-controlled trial. A total of 100 postoperative patients with Colles fracture, aged 20-80 years, will be recruited for this study. They will be randomly assigned to either the experimental or control group in a 1:1 allocation ratio. Both groups will receive standard postoperative Colles fracture treatment. The primary outcome measure will assess wrist functional recovery using the Patient-Rated Wrist Evaluation score. Secondary outcomes will include C-reactive protein levels and ultrasound measurements of wrist swelling. All of these examinations will be assessed at baseline, 3 days after surgery, and 6 days after surgery. In addition, the Dyshidrotic Eczema Area and Severity Index will be used to monitor for adverse skin reactions. Results: This protocol was registered at ClinicalTrials.gov on December 6, 2022. It was performed in accordance with the approved guidelines and regulations of the participating institutions. Recruitment began in May 2023, with data collection expected to conclude in May 2025. Study completion is expected in December 2025. Conclusions: This is the first protocol discussing the assessment of the therapeutic efficacy and safety of topical traditional Chinese medicine in patients after fracture surgery. The protocol will establish an integrated care model combining both traditional Chinese medicine and Western medicine for postsurgical fracture cases. Trial Registration: ClinicalTrials.gov NCT05638360; https://clinicaltrials.gov/ct2/show/NCT05638360

Background: French Guiana, an overseas territory located in the Guiana Shield in South America, faces unique social and demographic challenges, particularly in relation to migration. Haitians represent 1 of the 3 largest foreign communities in the region and face specific barriers to health care access and prevention. They are also a population exposed to HIV infection. Objective: This Parcours d’Haïti study aims to update knowledge on the health of the Haitian population residing in French Guiana. From a quantitative standpoint, the primary objective of this study was to assess the frequency of sexual behaviors that expose Haitian individuals to HIV risk after arriving in French Guiana and explore the association of this risk with their living conditions. This study adopts a transdisciplinary approach to understand the broader determinants of health and the processes underlying HIV transmission. Methods: This mixed methods study involves a quantitative epidemiological and biographical analysis of Haitian individuals aged 18 to 60 years who have lived in French Guiana for more than 3 months. The biographical component uses a detailed grid that tracks key life events since birth. The qualitative component includes 3 substudies based on semistructured interviews and focus groups with Haitian people and health care professionals. These aim to deepen understanding of health care access, use of traditional and biomedical care, and mental health among Haitians. A phylogenetic component describes the distribution of clades of the Pol gene in the viruses of people living with HIV. The study materials were cocreated with local stakeholders. Recruitment of this partially hidden population used an innovative method involving all local actors and targeting key locations frequented by the Haitian community. Data collection and recruitment were carried out by Haitian Creole–speaking peer investigators (community health mediators). Results: Over 20 months between 2021 and 2023, the Parcours d’Haïti study was implemented in French Guiana. Anticipated results suggest that the main reasons for migration include insecurity and fleeing violence. Upon arrival, Haitian people likely experience significant economic hardship and social isolation. Mental health deterioration is expected, with high rates of posttraumatic stress disorder. People living with HIV are expected to face heightened vulnerability compared to HIV-negative individuals even though they already struggle with precarious living conditions. The qualitative findings regarding health care use indicate that Haitian people encounter numerous barriers to accessing health care, such as administrative complexity, language, and financial and mobility issues. The anthropological results are expected to emphasize the magical-religious origins of HIV and the use of plants and traditional medicine for its treatment. Phylogenetic results are anticipated to show a high prevalence of Caribbean B HIV subtypes. Conclusions: The Parcours d’Haïti study aims to provide valuable insights into the health determinants and HIV-related risks in the Haitian population in French Guiana. These findings should help refine health care policies and practices to better meet the specific needs of this population. Trial Registration: ClinicalTrials.gov NCT05174234; https://clinicaltrials.gov/study/NCT05174234

Background: Australian Aboriginal children experience dental decay at more than twice the rate of non-Aboriginal children. The Select Committee into the Provision of and Access to Dental Services in Australia noted that the rate of potentially preventable hospitalizations was the highest among children aged between 5 and 9 years and was higher among Indigenous Australians and those living in remote locations. The application of a silver fluoride (AgF) solution to decayed surfaces has been shown to be effective in stopping the decay process and reducing the occurrence of new decay but has been tested to a limited extent in the Australian context. Objective: This study aims to evaluate the feasibility of using the skills of an Aboriginal health practitioner to undertake the application of AgF to carious primary molars to arrest the caries progression and prevent the occurrence of new caries among young Aboriginal children in remote communities. Methods: This study is a cluster-randomized controlled trial with communities randomized and stratified based on caries level and water fluoridation status. The trial will recruit 640 children (aged between 6 months and 7 years) from 30 communities. Informed consent will be obtained. At baseline, each child in the intervention group will be examined by a calibrated examiner and subsequently by an oral health practitioner who will prescribe to an Aboriginal health practitioner the teeth to be treated with AgF. A formulation with 38% AgF will be applied for 1 minute (0.004 mL per tooth). The control group will be provided with standard minimally invasive care. Participants will be followed annually for 2 years to assess caries arrest and prevention by blinded calibrated examiners. Child oral health–related quality of life and dental anxiety will be elicited through validated questionnaires. Tests of proportions will be used to evaluate the proportion of lesions arrested and the proportion of surfaces at risk that decayed over the follow-up. Multiple logistic regression with appropriate control for clustering of teeth and communities will be used to evaluate caries arrest, controlling for potential confounding factors. Results: Community engagement has commenced, and data collection protocols have been prepared. Staff specific to the study (eg, Aboriginal health practitioners or workers) are in the process of recruitment. Participant recruitment will commence in March 2026 and conclude in December 2026. Study outcomes will be reported at 12- and 24-month follow-ups. Conclusions: This study will test the effectiveness and feasibility of a non-oral health professional applying AgF to achieve caries arrest and prevention and validate clinical findings against digital imagery acquired on site. This pragmatic study will inform the development of suitable and accessible models of care for dental service provision in rural and remote communities in Australia. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12624000457549p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=387518&isReview=true

Background: Drug efflux mediated by transporter proteins is one of the major mechanisms conferring multidrug resistance (MDR) to antimicrobial agents in bacteria and to chemotherapeutics in cancer cells. Therefore, the development or identification of efflux modulators represents a promising strategy to overcome the resistant phenotype. Various chemical compounds have been tested in experimental studies as reversal agents either in combination with antimicrobial or anticancer drugs and have shown sensitizing activity in resistant bacteria or cancer cell lines. Owing to the common resistance mechanisms exhibited by bacteria and cancer cells, the identification of chemical agents with dual reversal activity offers a strategy to simultaneously combat antibacterial and cancer multidrug resistance. Objective: This study aims to conduct a systematic review to identify compounds that have shown activity in reversing antibacterial as well as cancer MDR mediated by drug efflux pumps and to summarize their structural and biological parameters responsible for the interactions with drug efflux pumps. Methods: The protocol has been developed in accordance with PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols) guidelines. We searched PubMed and Scopus databases for abstracts of full-text peer-reviewed journal papers in English language published between January 2012 and September 2024. Only studies from in vitro experiments were considered if they used methods to detect changes in antibiotic sensitivity of resistant bacteria and chemosensitivity of resistant cancer cells upon treatment with efflux pump inhibitors. A total of 763 unique records were identified. Of them, 246 were selected for full-text review based on the eligibility criteria. Abstract screening was performed by 2 independent reviewers. As of March 1, 2025, the systematic review is at the stage of completed abstract screening. The next steps of the full-text review, study selection, data extraction, and risk of bias assessment will be performed by 2 independent reviewers as well. Main data elements will include a structural identifier of the tested inhibitor, bacterial strain, cancer cell line, methods proving reversal activity, half maximal inhibitory concentration, and other relevant quantitative estimates of reversal activity. Data synthesis will be performed as a narrative summary and the content will be curated in tabular and graphical form. Results: We anticipate that results from this study will outline the potential of various compounds to act as dual chemosensitizers and reverse both antimicrobial and cancer MDR. Conclusions: Our review will highlight the overlap between efflux pumps’ inhibition as a strategy to combat MDR in both bacterial and cancer cells and it will provide structured data for rational drug design of dual efflux pump inhibitors. Trial Registration: PROSPERO CRD42024548350; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024548350

Background: Pudilan Xiaoyan oral liquid (PDL) is a proprietary Chinese medicine preparation widely used for upper respiratory tract infection, known for its significant therapeutic effects. However, the safety profiles reported in several observational studies vary, and these studies primarily focus on efficacy rather than specifically addressing safety concerns, thus representing inadequate safety monitoring. Objective: This study aimed to investigate the incidence of adverse drug reactions (ADRs) associated with PDL and explore the factors contributing to these reactions. Methods: The study is a prospective, observational, multicenter, hospital-based surveillance study. A total of 17 hospitals from China are involved. The study is expected to enroll a large sample of 10,000 patients aged between 18 and 80 years with upper respiratory tract infection who were prescribed PDL. The patients’ data, including demographics, medical history, diagnostic information, medication details, adverse events, and laboratory test results, will be monitored. The occurrence of ADRs will be recorded. The primary outcome is the incidence of ADR. Secondary outcomes are the ratio of patients whose body temperature return to the normal range (cases of body temperature normalization and the duration for achieving normal body temperature within a 3-day period will be documented) and changes in liver and kidney function (occurrence of drug-induced liver injury and acute kidney injury). Descriptive analyses will be performed for the primary and secondary outcomes. A cohort, nested, case-control study design will be used. If one patient has an ADR, then 4 patients without ADRs will be matched as the control group according to gender, age within 5 years, drug batch, and other factors, at a ratio of 1∶4 to compare the symptoms related to ADRs. The differences of ADR incidence among the possible influencing factors will be compared separately to find the factors with large differences. Then, synthetic minority oversampling technique and group least absolute shrinkage and selection operator methods will be used to identify factors influencing the occurrence of ADRs. Finally, propensity scoring methods will be used to control for confounding variables. The progress of each subcenter will be closely monitored, and the incidence of ADR will be systematically calculated. Furthermore, the characteristics and influencing factors of ADR will be analyzed, along with an investigation into its geographical distribution. Results: The study began on July 17, 2019. Due to the limited number of eligible patients, missed follow-ups, and the huge clinical burden caused by public health events in 2019, the final case will be enrolled on August 30, 2025. Conclusions: This study will obtain safety results of PDL in the real world and provide guidance on the clinical safety of traditional Chinese medicine formulations. Trial Registration: ClinicalTrials.gov NCT04031651; https://clinicaltrials.gov/study/NCT04031651

[Context] An evidence briefing is a concise and objective transfer medium that can present the main findings of a study to software engineers in the industry. Although practitioners and researchers have deemed Evidence Briefings useful, their production requires manual labor, which may be a significant challenge to their broad adoption. [Goal] The goal of this registered report is to describe an experimental protocol for evaluating LLM-generated evidence briefings for secondary studies in terms of content fidelity, ease of understanding, and usefulness, as perceived by researchers and practitioners, compared to human-made briefings. [Method] We developed an RAG-based LLM tool to generate evidence briefings. We used the tool to automatically generate two evidence briefings that had been manually generated in previous research efforts. We designed a controlled experiment to evaluate how the LLM-generated briefings compare to the human-made ones regarding perceived content fidelity, ease of understanding, and usefulness. [Results] To be reported after the experimental trials. [Conclusion] Depending on the experiment results.

Background: Global concern for the mental well-being of university students is on the rise. Recent studies estimate that around 30% of students experience mental health disorders, and nearly 80% of these individuals do not receive adequate treatment. Brazil, home to around eight million university students, lacks sufficient research addressing their mental health. To address this gap, we aim to conduct a longitudinal mental health survey at 2 Brazilian universities. Objective: This paper outlines the research protocol for a web-based mental health survey designed to assess the well-being of Brazilian university students. Methods: The survey targets undergraduate students (N=8028) from 2 institutions: UniFAJ (Centro Universitário de Jaguariúna) and UniMAX (Centro Universitário Max Planck). Students will be invited to respond to self-reported questionnaires, including theSMILE-U (lifestyle and quality of life), the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition]) self-rated level 1 cross-cutting symptom measure, and a brief version of the Adult Self-Report Scale for attention-deficit/hyperactivity disorder. Students who exceed thresholds for conditions such as depression, anxiety, and attention-deficit/hyperactivity disorder will receive additional diagnostic instruments. The survey will be conducted annually, tracking individual and group trajectories and enrolling new cohorts each year. Data will be analyzed using cross-sectional and longitudinal methods, focusing on descriptive, associative, and trajectory analyses. Results: The first wave of data collection began in February 2024 and is expected to conclude in December 2024. As of October 2024, a total of 2034 of 7455 (27.2 in 100) eligible students had completed the questionnaire. Cross-sectional statistical analysis is planned to commence immediately after data collection and is expected to be completed by June 2025. Conclusions: This survey uses a scalable, cost-effective design to evaluate mental health conditions among Brazilian university students. The longitudinal framework facilitates the monitoring of mental health trends, supports the development of targeted interventions, and informs policy initiatives in higher education. Trial Registration: OSF Registries OSF.IO/AM5WS; https://doi.org/10.17605/OSF.IO/AM5WS

Background: Metastasis is the primary cause of poor prognosis and high mortality in lung cancer. Surgery with postoperative adjuvant chemotherapy is the standard treatment for patients with stage IIA-IIIA lung cancer with negative driver genes. However, recurrence rates remain significant. In China, traditional Chinese medicine shows potential as an adjuvant therapy to reduce treatment toxicity and improve clinical efficacy. Objective: This study aimed to evaluate its efficacy and safety in preventing postoperative metastasis in driver gene-negative stage IIA-IIIA lung cancer, based on the promising preclinical results of Fuzheng Quxie Formula against lung cancer metastasis. In this trial, we hypothesize that the treatment group will have better efficacy and safety than the control group. Methods: A multicenter, double-blind, randomized, placebo-controlled parallel group trial will be conducted. Eligible patients will be randomized into a treatment group (daily Fuzheng Quxie Formula granules+regular chemotherapy) and a control group (daily Chinese medicine placebo granules+regular chemotherapy) in a ratio of 1:1. Fuzheng Quxie Formula will be administered orally, twice a day, in the morning and evening, for 6 months. Patients will be followed up after the end of treatment for 18 months. After the end of the program, follow-up will be continued for 5 years or until the patient dies (or progressed). The primary efficacy endpoint is disease-free survival, and the secondary efficacy endpoints are overall survival, minimal residual disease, circulating tumor cells, Chinese medicine symptom score, quality-of-life assessment, immune indicators, tumor markers, peripheral blood systemic immune-inflammation index, and prognostic nutritional index. We will conduct per-protocol analyses on these outcomes. In addition, we will also evaluate the safety of the Fuzheng Quxie Formula. Results: This study began screening and recruitment in March 2023. Recruitment is ongoing; by the end of 2024, a total of 180 eligible participants will be enrolled. Recruitment will continue until the end of June 2025 or until the target sample is reached. We estimate that the results will be published by March 2026. Conclusions: This study is a high-quality, large-scale, multicenter, double-blind, randomized controlled trial. This will be the first trial to evaluate the efficacy and safety of Fuzheng Quxie Formula in inhibiting metastasis after surgery in stage IIA-IIIA lung cancer with negative driver genes. Provide a basis for the clinical application of Fuzheng Quxie Formula. Trial Registration: ClinicalTrials.gov NCT06381960; https://clinicaltrials.gov/study/NCT06381960

Background: Combating the rise of drug-resistant organisms and minimizing side effects requires a shift in how we approach the duration of antibiotic therapy. A promising strategy involves tailoring the length of antibiotic therapy to patients’ needs, allowing discontinuation once patients feel better. Objective: This study aims to assess whether shortening antibiotic therapy based on patients’ recovery time is as effective as completing the full course in treating acute respiratory tract infections (RTIs). Methods: We plan to enroll a minimum of 474 outpatients ranging from 18 to 75 years of age with clinical features of acute RTIs across Spanish health centers. Patients diagnosed with acute lower RTIs or acute rhinosinusitis, deemed by clinicians to require a β-lactam course, will be randomized to either usual care, involving a full-course antibiotic therapy based on current guidelines, or a tailored approach. In the intervention group, patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment and C-reactive protein rapid testing. Treatment will be discontinued if these clinical results are normal. The primary outcome will be assessment of clinical resolution at day 14, while secondary outcomes include antibiotics given and duration; adherence to the prescribed antibiotic; other therapies given; early clinical assessment at day 7; days of severe, moderate, and any symptom, complications and reattendance within the first month; drug-related adverse events; absenteeism; and health-related quality of life. All participants will be given a symptom diary, recording their symptoms each evening. Additionally, a cost-effectiveness study and qualitative studies involving clinicians and patients aimed at exploring the strategy’s pros, cons, uptake, and satisfaction levels will be carried out. Results: The final results will be published by the end of 2027. Conclusions: We will examine whether adults who present with symptoms of RTI who are treated with antibiotic courses until they feel better are as effective as longer standard courses. It is highly important that a possible reduction in the antibiotic course as soon as the patient feels better does not compromise patients’ recovery. This comprehensive approach aims to shed light on the practicality and impact of tailoring antibiotic duration in RTIs. Trial Registration: ClinicalTrials.gov NCT06581367; https://clinicaltrials.gov/study/NCT06581367

Background: While access to pre-exposure prophylaxis (PrEP) is an important tool for reducing HIV incidence in the United States, disparities in uptake by race, sex, socioeconomic status, and geography persist. In 2018, the US South accounted for more than half of all new HIV diagnoses but only one-third of PrEP users. PrEP use in North Carolina (NC) similarly lags, with uptake being the lowest among young, sexual and gender minority populations, who account for nearly two-thirds of the state’s incident infections. The PrEP-to-need ratio, a metric of PrEP equity that measures PrEP uptake relative to new HIV diagnoses, highlights disparities in PrEP uptake among specific demographic groups such as women and Black, Hispanic, and Southern people, indicating that these groups are underserved relative to their epidemic need. Despite behavioral risk overlap of incident sexually transmitted infections (STIs) and HIV, in NC, PrEP is only offered at a few primarily urban health department–affiliated STI clinics. The lack of robust health care infrastructure in these areas presents challenges for HIV prevention services. Objective: This protocol describes a randomized controlled trial of a multilevel PrEP intervention recruiting from rural and periurban STI clinics. Methods: This trial aims to enroll up to 336 participants and randomly assign them 1:1 to either the intervention or control group. The intervention consists of access to a digital health app, linkage to a remote PrEP navigator, and the option of referral to telehealth-based PrEP services. Persons randomly assigned to the control condition will receive an enhanced standard of care, including access to a limited version of the digital health app. All participants will be followed up on quarterly for at least 3 months. The primary outcome is the initiation of PrEP within 3 months of an index STI clinic visit; secondary outcomes evaluate PrEP care engagement and adherence, incident HIV and bacterial STI infections, PrEP stigma, and cost-effectiveness. Binary outcome analyses will estimate the proportion of participants achieving an event (eg, PrEP uptake) in each arm and a probability difference and the corresponding 95% CI to compare the intervention versus control arm at each time point. Continuous end points will use nonparametric Wilcoxon rank sum tests comparing the intervention and control groups. Results: Enrollment opened on August 31, 2023, at 15 health departments in NC and subsequently expanded to 21 facilities in 20 counties by July 2024. Completion of the enrollment and data collection phases is expected by May 2025. Results will be published thereafter. Conclusions: This study directly addresses multiple barriers to PrEP use in rural and periurban areas of the Southeastern United States and can inform policy and programming that seek to expand PrEP access and promote use in underserved communities. Trial Registration: ClinicalTrials.gov NCT05984030; https://clinicaltrials.gov/study/NCT05984030

Background: The incidence of many common chronic childhood conditions has increased globally in the past few decades, which has been suggested to be potentially attributed to antibiotic overuse leading to dysbiosis in the gut microbiome. Objective: This linkage study will assess the role of antibiotic use in utero and in early life in the development of type 1 diabetes (T1D), attention-deficit/hyperactive disorder (ADHD), and inflammatory bowel disease. Methods: The study design involves several retrospective cohort studies using linked administrative health and social data from Statistics New Zealand’s Integrated Data Infrastructure. It uses data from all children who were born in New Zealand between October 2005 and December 2010 (N=334,204) and their mothers. Children’s antibiotic use is identified for 4 time periods (at pregnancy, at ≤1 year, at ≤2 years, and at ≤5 years), and the development of T1D, ADHD, and inflammatory bowel disease is measured from the end of the antibiotic use periods until death, emigration, or the end of the follow-up period (2021), whichever came first. Children who emigrated or died before the end of the antibiotic use period are excluded. Cox proportional hazards regression models are used while adjusting for a range of potential confounders. Results: As of September 2024, data linkage has been completed, involving the integration of antibiotic exposure and outcome variables for 315,789 children. Preliminary analyses show that both prenatal and early life antibiotic consumption is associated with T1D. Full analyses for all 3 outcomes will be completed by the end of 2025. Conclusions: This series of linked cohort studies using detailed, complete, and systematically collected antibiotic prescription data will provide critical new knowledge regarding the role of antibiotics in the development of common chronic childhood conditions. Thus, this study has the potential to contribute to the development of primary prevention strategies through, for example, targeted changes in antibiotic use.

Background: Despite the availability of highly effective HIV pre-exposure prophylaxis (PrEP), uptake and adherence to PrEP among young men who have sex with men (YMSM) remains low, limiting its impact on the prevention of HIV infection. Strategies that incorporate an array of prevention options and provide YMSM and their providers with tailored education and support tools, including tools to support shared decision-making, are needed. Objective: The goals of the Centers for Disease Control and Prevention (CDC)–funded PrEP Choice study include the development and deployment of CDC guideline–consistent PrEP provider training and the implementation of evidence-based provider- and client-facing PrEP education and support tools. Under this initiative, the CDC funded 2 research projects, Florida State University (the Expanding PrEP in Communities of Color [EPICC] project), and Columbia University (the mChoice project). Methods: Providers from both projects will complete the PrEP Choice online training, which was developed to educate providers on PrEP options and how to engage clients in open discussions around sexual health and PrEP options. EPICC project providers will also attend online tailored motivational interviewing (TMI) training sessions, and mChoice project providers will view a training video on cultural competency and humility in PrEP care. Following training, each project will enroll a cohort of 400 participants receiving care from study providers and follow them for 12-18 months. Participants will complete online surveys every 3 months and provide biomarkers to assess PrEP adherence. Electronic health record (EHR) data will be collected every 6 months to provide additional information on clinic attendance, PrEP prescriptions, and HIV/sexually transmitted infection (STI) testing. Each project will provide cohort participants with a unique digital health tool to support the PrEP choice and ongoing adherence. The study will assess the effectiveness of training and educational and support tools in practice and the critical factors associated with the successful uptake of and adherence to PrEP by participants. The study will also monitor patterns of PrEP use among YMSM, including types of PrEP and switching between types. Results: Formative work to develop and prepare the tools for implementation was completed in 2023. The EPICC project began provider training in early 2024, and the mChoice project began in spring 2024. Cohort enrollment for both projects began after provider training began. Conclusions: Given the changing PrEP landscape, implementation of provider education and tools to maximize uptake and adherence is needed. By delivering culturally competent and interactive provider training on PrEP options, the study will help providers counsel and guide participants on the effective and safe use of PrEP. The digital health tools created will support participant adherence to help them optimize PrEP benefits. Through the cohort design, the PrEP Choice study will provide real-world data about PrEP use that will be critical for informing future guidelines and tools.

Background: Measuring vital signs (VS) is important in potentially unwell children, as a change in VS may indicate a more serious infection than is clinically apparent or herald clinical deterioration. However, currently available methods are not suitable for regular measurement of VS in the home or community setting, and adherence can be poor. The COVID-19 pandemic highlighted a need for the contactless measurement of VS by nonclinical personnel, reinforced by the growing use of telemedicine. The Lifelight app is being developed as a medical device for the contactless measurement of VS using remote photoplethysmography via the camera on smart devices. The VISION-D (Measurement of Vital Signs by Lifelight Software in Comparison to the Standard of Care—Development) and -V (Validation) studies demonstrated the accuracy of the app compared with standard of care (SOC) measurement of blood pressure, pulse rate (PR), and respiratory rate (RR) in adults, supporting certification of Lifelight as a class I Conformité Européenne medical device. Objective: To support the development of the Lifelight app for pediatric patients, the VISION-Junior study is collecting high-quality data that will be used to develop algorithms for the measurement of VS (PR, RR, and oxygen saturation) in pediatric patients. The accuracy of the app will be assessed against SOC measurements made simultaneously with app measurements. Methods: The study is recruiting pediatric patients (younger than 18 years of age) attending the Sunderland Royal Hospital pediatric emergency department of the South Tyneside and Sunderland National Health Service Foundation Trust. High-resolution videos of the face (and torso in children younger than 5 years of age) and audio recordings (to explore the value of crying, wheezing, coughing, and other sounds in predicting illness) are made using the Lifelight Data Collect app. VS are measured simultaneously using SOC methods (finger clip sensor for PR and oxygen saturation; manual counting of RR). Feedback from patients, parents, carers, and nurses who use Lifelight is collected via questionnaires. Anticipated recruitment is 500 participants, with subtargets for age, sex, and skin tone distribution (Fitzpatrick 6-point scale). Early data will be used to refine the algorithms. A separate dataset will be retained to test the performance of the app against predefined targets. Results: The study started on June 12, 2023, and reached its recruitment target (n=532) in April 2024 after extending the deadline. Algorithm refinement is in progress, after which the performance of Lifelight will be compared with the SOC measurement of VS. The analyses are expected to be completed by mid-August 2024. Conclusions: Data collected in this study will be used to develop and assess the accuracy of the app for the measurement of VS in pediatric patients of all ages. Trial Registration: ClinicalTrials.gov NCT05850013; https://clinicaltrials.gov/study/NCT05850013

Background: Dementia is a global health priority with significant challenges due to its complex nature and increasing prevalence. Health systems worldwide struggle to address chronic conditions like dementia, often providing fragmented care. However, information about how health systems respond to the needs of people with dementia and their carers, and the quality of care provided, is scarce in low- and middle-income countries. Objective: This study aims to assess the quality of the health system to provide diagnosis and care for people with dementia and their carers in Peru. In order to do this, the study will explore the response of the Peruvian health system to people with dementia and their carers, and explore the experiences of people with dementia of receiving their diagnosis, management, and quality of care for this condition. Methods: This study is part of a research program called “IMPACT Salud: Innovations using Mhealth for people with dementia and Co-morbidities,” aimed at strengthening health systems to provide care for people with dementia and their carers. The study has a descriptive, cross-sectional design that uses a qualitative methodology, including stakeholder interviews and documentation review, and consists of 2 substudies, a health system assessment (HSA) and an exploration of the patient journey. The first substudy uses an HSA methodology suitable for low- and middle-income countries, conducting 160 structured interviews with 12 different stakeholder types across 3 levels of the health system (micro, meso, and macro) in 4 Peruvian regions, each with distinct geographical and urbanization profiles. The second substudy uses a patient journey methodology, which involves conducting 40 in-depth interviews with people with dementia, carers, and health care workers from the same 4 regions. The insights into the people with dementia patient and caregiver experience within the health system from the interviews will be used to produce a patient journey map. The analysis will be guided by the high-quality health system framework, and the findings from the HSA and patient journey will be structured using the domains included in the framework through the lens of quality of services. Results: Data collection began in March 2024. As of the end of September 2024, a total of 156 interviews from the HSA and 38 interviews from the patient journey study have been conducted across 4 regions. Conclusions: This study will provide a national, multilevel insight into the current operation of the Peruvian health system, including an analysis of the quality of services provided with regard to dementia diagnosis, management, and care from the perspectives of stakeholders, patients, and their carers.

Background: This study describes the protocol for a realist process evaluation of IMPART (Improving Palliative Care in Residential Aged Care Using Telehealth), to be trialed through a pragmatic stepped-wedge cluster randomized controlled trial in Australia. IMPART consists of 2 key intervention activities: specialist palliative support provided through telehealth and tailored staff education. Objective: The aims of the realist process evaluation are to (1) identify and explore the contexts and mechanisms that enable or hinder the implementation of the IMPART intervention, and (2) develop and refine a program theory to determine whether and how successful implementation of IMPART can be facilitated. Methods: We will conduct this process evaluation in 3 phases, guided by a realist framework. First, to hypothesize an initial program theory, we will review trial documentation and literature to determine how IMPART is expected to work and identify the barriers and facilitators likely to influence implementation. To test this theory in the second phase, a case study methodology will draw on multiple data sources (qualitative and quantitative) from 10 participating residential aged care facilities. These include interviews with staff involved in implementation, data on staff engagement with training, program documentation, activity logs, action plans, and facility information. In the final phase, program theories developed from the case studies will be refined through consultation with the IMPART research team. This will inform the development of a refined program theory that provides key information about what works, for whom, how, and in what circumstances in the implementation of interventions aiming to improve palliative care in residential aged care. Results: This study was reviewed and approved by the Royal Melbourne Hospital Human Research Ethics Committee. The randomized controlled trial commenced in May 2023, with completion anticipated in November 2025. Funding began in January 2022. Data for the realist process evaluation will be collected between May 2023 and February 2026. As of October 2025, a total of 61 interviews have been completed. Data analysis is ongoing, and a publication describing the results will be prepared in 2026. Conclusions: Applying a realist framework to explore process outcomes allows for an in-depth inquiry into what works, for whom, how, and in what circumstances in the implementation of complex interventions aiming to improve palliative care in residential aged care. This realist process evaluation has the potential to provide transferable, context-specific findings that can support the development of meaningful policy and accelerate practice change. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622000760774; https://tinyurl.com/2uv34unr

Background: Generative artificial intelligence (GenAI) leverages large language models (LLMs) that are transforming health care. Specialized ambient GenAI tools, like Nuance Dax, Speke, and Tandem Health, “listen” to consultations and generate clinical notes. Medical-focused models, like Med-PaLM, provide tailored health care insights. GenAI’s capability to summarize complex data and generate responses in various conversational styles or literacy levels makes it particularly valuable since it has the potential to alleviate the burden of clinical documentation on health care professionals (HCPs). While GenAI may prove to be helpful, offering novel benefits, it comes with its own set of challenges. The quality of the source data can introduce biases, leading to skewed recommendations or outright false information (so-called hallucinations). In addition, due to the conversational nature of chatbot responses, users may be susceptible to misinformation, posing risks to both safety and privacy. Therefore, careful implementation and rigorous oversight are essential to ensure accuracy, ethical integrity, and alignment with clinical standards. Despite these advances, currently, no review has investigated HCPs’ experiences and opinions about GenAI in clinical documentation. Yet, such a perspective is crucial to better understand how these technologies can be safely and ethically adopted and implemented in clinical practice. Objective: We aim to present the protocol for a scoping review exploring HCPs’ experiences and opinions about GenAI and ambient scribes in clinical documentation. Methods: This scoping review will be carried out following the methodological framework of Arksey and O’Malley and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews) checklist. Relevant papers will be searched for in PubMed, IEEE Xplore, APA PsycInfo, CINAHL, and Web of Science. The review will include studies published between January 2023 and September 2025. Studies will be included that represent original peer-reviewed work that explores HCPs’ experiences and opinions about the use of GenAI or ambient scribes for clinical documentation. Data extraction will include publication type, country, sample characteristics, clinical setting, study aim, study design, research question, and key findings. Study quality will be assessed using the Mixed Methods Appraisal Tool. Results: The results will be presented as a narrative synthesis structured along the key themes of the evidence mapped. Data will be collated and presented in charts and tabular format. Findings will be reported in a peer-reviewed scoping review. Conclusions: This will be the first scoping review that considers HCPs’ experiences and opinions about GenAI and ambient scribes in clinical documentation. The results will clarify how HCPs use—or avoid using—GenAI in daily health care work. This insight will help address perceived benefits, risks, expectations, and uncertainties. It may also reveal key research gaps in the field.

Background: Pregnancy is a complex period involving significant physical, mental, and social changes in a woman’s life, affecting her psychological well-being. According to the literature, anxiety, stress, and depression are common symptoms among pregnant women. Promoting a healthy lifestyle with a focus on mental health is essential. In this context, digital solutions such as coaches on smartphones are emerging as valuable tools to support the psychological well-being of pregnant women without existing disorders. Objective: This study aims to present the research protocol of a pilot study designed as a proof-of-concept investigation. The study evaluates the feasibility, acceptability, and utility of an acceptance and commitment therapy–based stress management mobile app. The primary objective is to explore the feasibility of using a coach, ALBA (A Well-Being Assistant), developed within the TreC Ricerca app, to promote women’s psychological well-being during pregnancy through 5 sessions based on acceptance and commitment therapy. The pre- and postintervention effects on psychological well-being will also be explored as a secondary objective, serving as a proxy for the potential impact of the intervention. Methods: The study serves as a proof-of-concept investigation, where a small sample size (N=50) is deemed adequate to fulfill the study’s objectives. Participant recruitment will be conducted among pregnant women affiliated with the pregnancy care services of the Azienda Provinciale per i Servizi Sanitari di Trento, using a convenience sampling approach. ALBA will interact with the participating women for 6 weeks, between the 14th and 26th weeks of gestation. Specifically, there will be 1 session per week, which the woman can choose, to allow more flexibility regarding her needs, supplemented by ALBA-supported exercises to be performed between sessions. This study adopts a mixed methods approach, combining quantitative and qualitative data collection and analysis. Usability and engagement are assessed using the System Usability Scale, Chatbot Usability Questionnaire, User Engagement Scale-Short Form, and the User Mobile Rating Scale. Moreover, other quantitative outcome measures include levels of stress, anxiety, depression, emotional regulation, psychological flexibility, coping strategies, self-efficacy, and overall well-being, along with qualitative data from semistructured interviews. Finally, the analysis of the data gathered in this study will primarily adopt descriptive statistics and a text mining approach, focused on evaluating the attainment of the study objectives and changes over experimental time. Results: The psychoeducational approach aims to yield notable outcomes regarding the usability and engagement of women with ALBA. Furthermore, an anticipated enhancement in psychological well-being and quality of life is expected. Conclusions: Existing literature indicates a preference among women in the perinatal period for online support, highlighting the potential of digital interventions to address barriers related to social stigma and seeking assistance. In this context, ALBA emerges as a valuable resource, providing consistent psychoeducational support for women throughout pregnancy.

Background: Mobility impairment and participation restrictions are commonly experienced by individuals with autosomal recessive spastic ataxia of Charlevoix-Saguenay (ARSACS) and myotonic dystrophy type 1 (MD1), 2 disorders that are highly prevalent in the province of Quebec, Canada. People with ARSACS and MD1 experience a progressive decline in mobility, which commonly results in the provision of manual or power wheelchairs. While wheelchairs can facilitate mobility and social participation, their provision alone does not guarantee safe and effective use. Wheelchair skills training has been shown to be effective for improving manual skills and confidence among adult users with various diagnoses, which may enhance self-directed mobility and participation and reduce the risk of chronic and acute injuries. However, manual wheelchair skills training for people with ARSACS and MD1 remains understudied. Objective: The primary aim of this study is to evaluate the efficacy of manual wheelchair skills training for safely improving wheelchair performance in people with ARSACS and MD1. The secondary outcomes include exploring the influence of manual wheelchair skills training on skill capacity, use self-efficacy, mobility, and the retention of outcomes 3 months later. We will also qualitatively explore the manual wheelchair training experiences of people with ARSACS and MD1. Methods: This study will use a sequential multimethods design, combining a waitlist randomized controlled trial and qualitative interviews. The participants will include adults who have a diagnosis of ARSACS or MD1 who use a manual wheelchair for mobility. Participants will be randomly assigned to the intervention or control group using a 1:1 allocation ratio. The intervention group will receive 5 manual wheelchair skills training sessions (1-2 sessions/week), while the control group will receive no training. Data will be collected at baseline (T1), after the 4-week intervention (or waiting period for the control group; T2), and 3 months after T2 to assess retention (T3). The primary outcome will be manual wheelchair skills performance. Secondary outcomes will include manual wheelchair skills capacity, self-efficacy, and mobility. Semistructured individual interviews will be conducted to explore participants’ expectations regarding manual wheelchair use, past manual wheelchair experiences, and perceptions of manual wheelchair skills training. Quantitative data will be analyzed using analysis of covariance (ANCOVA), controlling for baseline scores, and qualitative data will be analyzed using reflexive thematic analysis. Results: This study received ethical approval (2025-3100) in July 2024. Recruitment started in January 2025. A graduate student, a research assistant, and a research coordinator have been recruited and trained. Conclusions: The results of this randomized waitlist-controlled trial will confirm whether manual wheelchair skills training can improve self-directed mobility and related outcomes for people with ARSACS and MD1. The findings may help guide clinical practice toward manual wheelchair skills training for understanding potential influences on manual wheelchair mobility in people living with neuromuscular disorders. Trial Registration: ClinicalTrials.gov NCT06596850; https://clinicaltrials.gov/study/NCT06596850

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.