Background: This study explores the treatment of internal carotid artery stenosis in patients with a high risk for cardiovascular events. The use of regional anesthesia permits ongoing neurological monitoring and enhances patient safety during the procedure. However, the operation can be stressful and lengthy, highlighting the need for strategies to alleviate patient discomfort. This study evaluates audiovisual distractions such as video goggles to potentially improve patient experiences during carotid surgeries, a topic that has not yet been comprehensively researched. Objective: We aimed to (1) determine whether there is a benefit for patients regarding stress reduction when using video goggles during vascular surgery of the carotid artery and (2) determine whether any parameters can effectively measure such a potential benefit. Methods: This prospective, randomized study at the University Hospital Augsburg is evaluating the use of HappyMed video goggles by patients undergoing carotid endarterectomy under regional anesthesia. Participants are randomized into either the intervention group, which receives the video goggles, or the control group, which does not. The surgical and anesthetic procedures remain consistent across both groups. Patients are eligible if they meet the surgical criteria, are able to lie supine, and are cooperative. Patients are excluded if they are receiving corticosteroids, have dementia, or have a language barrier. The study uses questionnaires and vital/laboratory parameters, including cortisol levels and heart rate, to assess stress and anxiety. To monitor potential motion sickness, the occurrence of nausea or vomiting is documented. Both patients and surgical staff will evaluate the experience postoperatively to determine the goggles’ impact on patient experience and stress management during surgery. Results: The study has been approved by the local ethics committee and is registered at ClinicalTrials.gov. Patient inclusion started in September 2022 and should be completed within 3 to 4 years. This paper presents a study protocol that was finalized and approved by the local ethics committee in September 2022. At the time of this protocol’s final submission for publication, approximately 90% of the recruitment had been completed. Following completion of recruitment and data acquisition, the results are intended to be published within one year. Conclusions: This study aims to improve patient comfort and perioperative care during vascular surgery. Therefore, our study aims to investigate if the use of video goggles during surgery is feasible and if there are parameters that indicate a benefit for patients. This study is being conducted as a pilot trial to provide a foundation for future research aimed at improving patient comfort during carotid artery surgery under local anesthesia. Clinical Trial: ClinicalTrials.gov NCT06704230; https://clinicaltrials.gov/study/NCT06704230

Background: Sleep disturbance is one of the most common health concerns reported by individuals who have survived breast cancer (BC) and is associated with poor quality of life (QoL) and greater mortality after treatment. Cognitive behavioral therapy for insomnia (CBTi) has shown efficacy for improving sleep and QoL for this population. Considered the gold standard for insomnia treatment, CBTi can be delivered remotely, including via digital intervention. Despite the potential for wider dissemination of CBTi via digital means, these modalities have unique challenges, including technology barriers and poor adherence. We developed a conversational agent (CA) to deliver CBTi via a SMS text messaging intervention, supported by mobile-ready web content. Named “Cecebot,” this CA delivers sleep education, implements sleep compression, provides just-in-time interventions for sleep-disrupting behaviors, and includes enhanced support for physical activity (PA) beyond what is typically included in CBTi. This represents a novel modality for a CBTi and PA intervention among individuals who have survived BC. Objective: We aim to examine the safety and acceptability of the Cecebot intervention, developed by an academic partnership between Dr Reding’s research team and Moby Inc, for individuals who have survived BC and experience symptoms of insomnia, and to explore its efficacy. Methods: This trial will recruit 60 individuals who have survived BC and are experiencing moderate to severe sleep disturbance. Participants will be assigned to the Cecebot intervention or waitlist control group at a 1:1 ratio. The treatment group will receive the Cecebot intervention during weeks 1-6 of the study, while the waitlist control condition will receive the Cecebot intervention during weeks 6-12. The Cecebot intervention uses SMS text messaging technology paired with a Fitbit. Participants will be assessed at baseline, week 6, and week 12. Measurements will include feasibility and acceptability and will explore the effect of the Cecebot intervention. Feasibility will be assessed through recruitment, enrollment, and retention rates. Acceptability will be evaluated using a satisfaction survey and open-ended responses. Quantitative analysis, such as t test, Fisher exact tests, and generalized linear models, will be used to assess feasibility, baseline group differences, and the outcomes of the intervention. Results: Recruitment of participants began in Fall 2024. The completion of data collection is anticipated to be by Fall 2025. Conclusions: The study results will give insight into the potential for an SMS text messaging–based CA to improve sleep in individuals who have survived BC and experience sleep disturbances. Trial Registration: ClinicalTrials.gov NCT06392789; https://clinicaltrials.gov/study/NCT06392789

Background: Nursing in palliative medicine combines primary patient care with the special challenges of this medical field (eg, handling the processes of dying, grief, and death). These cause high stress levels and burden on the nursing staff, resulting in an early exit from working life because of physical or psychological disorders like burnout. Objective: DiPa (digitally identifying and minimizing stressors in palliative care) is a prospective study investigating the feasibility of measuring burden and its causes in palliative care using methods of subjective and objective stress detection. Based on these results, stress-reducing interventions are to be deduced and evaluated. In this paper, we present our study protocol. Methods: The nursing staff of an inpatient university palliative hospital ward gathered data over 6 weeks. Each was equipped with a smart wristband and a smartphone that continuously measure physiological and ambient parameters throughout their working day. These objective data were enriched by subjective measurements: a questionnaire at the beginning of the study that assessed multiple potential stressful situations and constellations in the private and working environment as well as ecological momentary assessments (EMAs) during the workday. The EMAs were prompted by scanning near-field communication (NFC) tags placed at different locations on the ward. The ongoing data analyses will be processed using computer algorithms partly programmed specifically for this study and partly drawn from existing libraries, such as toolboxes for neurophysiological signal processing for Python. Comparisons between subjective and objective measures and group comparisons between variables of interest will be made using inferential statistics, including regression analyses and analyses of variance. Data analysis using machine learning algorithms will be implemented once sufficient data are gathered. Results: The study was funded in October 2019. As of July 2025, 12 of 18 nurses in the palliative care unit consented to participate in our study. We expect to start detailed data analysis in in the third quarter of 2025 and to finish and publish our results in 2026. Conclusions: The DiPa study aims at testing the feasibility of measuring and merging subjective and objective stress parameters for palliative care nurses. Trial Registration: German Register for Clinical Studies DRKS00024425; https://drks.de/search/en/trial/DRKS00024425/details

Background: Kissing is a common social behavior that may influence physiological responses and impact oral health. Prior research has shown that affectionate behaviors like kissing can reduce stress and improve relationship satisfaction. However, the effects of kissing on salivary pH, particularly after consuming sugary or fermented beverages, have not been thoroughly investigated. Objective: This study aims to determine whether kissing accelerates salivary pH recovery following the consumption of sugary or fermented beverages. Methods: A randomized controlled trial will be conducted with 60 couples aged 18-30 years. Participants will be divided into 3 groups: a control group (no kissing), an experimental group where one partner consumes a beverage, and another experimental group where both partners consume a beverage. The study will measure salivary pH at baseline, after beverage consumption, and following a 40-second kiss or control period, with measurements taken every 5 minutes until the pH returns to neutral levels. The data will be analyzed using SPSS software (IBM Corporation). ANOVA will be used to compare salivary pH recovery between groups, and if assumptions of normality or sphericity are not met, alternative models such as generalized linear models or nonparametric tests will be considered. Results: The study is ongoing, with participant recruitment already initiated and preliminary data collection in progress. The study was funded by the Catholic University of Santiago de Guayaquil from June 2024 to June 2025. Ethics approval was obtained in June 2023. The results are expected to be published in the last quarter of 2025. Conclusions: This study will provide insights into the relationship between kissing, salivary pH, and oral health, potentially offering new strategies for the prevention of dental caries. The results may challenge existing assumptions about the role of kissing in oral health. Clinical Trial: ClinicalTrials.gov NCT06501729; https://clinicaltrials.gov/study/NCT06501729

Background: The US Veterans Affairs mental health residential rehabilitation treatment programs (MH RRTPs) provide residential care for veterans experiencing homelessness. However, those with co-occurring mental health and substance use disorders and criminal legal involvement require additional interventions to address risk factors for recidivism. Objective: We aimed to (1.1) evaluate whether the Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking Criminal Justice version (MISSION-CJ) intervention lowers criminal recidivism and improves health-related outcomes; (1.2) examine the mechanisms that impact outcomes; and (2) qualitatively assess the implementation of MISSION-CJ. Methods: Veterans participating in an MH RRTP (N=226) will be randomized to the enhanced usual care (EUC) or MISSION-CJ conditions in a hybrid type 1 randomized controlled trial to test the effectiveness and implementation of MISSION-CJ, a multicomponent intervention for co-occurring disorder. Both conditions will receive 6 months of services beginning within a week of MH RRTP enrollment (duration of stay: 3 months) and continue for 3 months after the MH RRTP in the community. The veterans in the EUC group (113/226, 50%) will receive a peer support curriculum and community outreach and linkage delivered by a peer support specialist. The veterans in the MISSION-CJ group (113/226, 50%) will receive team-based (case manager and peer support specialist) care, including treatment planning, case management using a critical time intervention model to promote referrals and linkages, enhanced dual recovery therapy sessions, and peer support sessions. Assessments, including questions regarding substance use and mental health history, criminal history and recidivism risk, housing, employment, medication adherence, mutual-help group attendance, antisocial attitudes, affiliations with peers, community involvement, and treatment services received, will be conducted at baseline and 6 months and 15 months after baseline. We will use generalized linear mixed effects regression models to evaluate MISSION-CJ based on outcomes (objective 1.1). We will conduct mediation analysis to examine mechanisms of action (objective 1.2). For the qualitative evaluation (objective 2), we will use thematic analysis to identify themes. Results: As of March 2025, 118 veterans (site 1: n=52, 44.1% and site 2: n=66, 55.9%) have been enrolled. Overall, 58 veterans (site 1: n=27, 47% and site 2: n=31, 53%) have been randomized to the MISSION-CJ group, and 60 veterans (site 1: n=25, 42% and site 2: n=35, 58%) have been randomized to the EUC group. Overall, 23 interviews for the qualitative evaluation have been completed with veterans. Veterans are continuing to receive treatment and completing follow-up assessments. The findings from this trial and qualitative evaluation will be available by 2026. The quantitative and qualitative components of this project are intended to work synergistically to reinforce knowledge of MISSION-CJ’s effectiveness, implementation, and scalability. Conclusions: If effective, the implementation of MISSION-CJ alongside the MH RRTPs may be advantageous to address risk factors related to recidivism. Trial Registration: ClinicalTrials.gov NCT04523337; https://clinicaltrials.gov/study/NCT04523337

Background: University students and staff members, especially those who frequently eat out and spend considerable time on campus, form a crucial demographic facing challenges related to high salt and sugar intake in out-of-home food. Recognizing the high prevalence of eating out among these populations, it is imperative to understand the salt and sugar consumption levels of campus communities. Objective: This protocol describes the rationale and design of a 3-part cross-sectional and longitudinal interventional study to reduce salt and sugar contents in canteen foods and intakes among students and staff at Sunway University and Sunway College in Malaysia. Methods: First, the knowledge, attitudes, and practices (KAPs) and perception, barriers, and enablers (PBEs) of salt and sugar intake and reduction were assessed among students and staff (part 1 of the study). Second, the KAPs and PBEs of salt, oil, and sugar reduction were assessed among canteen staff (part 2 of the study). Third, a longitudinal interventional study was conducted by implementing a campus-wide executive order to reduce salt and sugar in all foods sold on campus (part 3 of the study). The salt and sugar contents of selected foods were measured at baseline and at 3 months and 6 months postreduction. Participants who eat frequently on campus were selected as the intervention group, while those who do not comprised the control group. All participants had their urine electrolytes and body compositions measured and recorded 24-hour dietary intakes for 2 weekdays and 1 weekend at baseline, 3 months, and 6 months after salt and sugar reduction. Results: The study protocols were approved by the institutional review board of Sunway University (SUREC 2024/029 and SUREC 2024/040). Recruitment for the cross-sectional studies began in May 2024, while that for the longitudinal intervention study began in June 2024. The 6-month intervention began in September 2024 immediately after the official launch of the campus-wide executive order to reduce salt and sugar. We targeted recruitment of 1000, 50, and 300 participants for parts 1, 2, and 3, respectively. We anticipate reduced dietary salt and sugar intakes by 30% and 50%, respectively (World Health Organization targets), and beneficial health effects on the participants. Conclusions: The insights gained from this study will help to create a healthier food environment, benefitting individuals who regularly eat out, especially at the workplace. Trial Registration: ClinicalTrials.gov NCT06473038; https://clinicaltrials.gov/study/NCT06473038

Background: Pressure in combination with shear forces can deform soft tissues and lead to development of pressure ulcers. The prevalence rate of pressure ulcers in the United Kingdom remains unacceptably high and can occur across the human lifespan. The posterior heel represents a common anatomical site for pressure ulcers due to soft tissues lying adjacent to bony prominences and being exposed to pressure and shear during lying postures. Localized cooling and interface materials that reduce shear may offer potentially therapeutic benefits in the development of pressure ulcers. Yet the physiological mechanisms underpinning the potential benefits of localized cooling are not fully understood. Objective: This study protocol aims to investigate how localized cooling influences the skin’s microvascular, inflammatory, structural, and perceptual tolerance to repeated shear loading at the heel. Methods: The protocol will be tested on individuals of different age, sex, skin tone, and comorbidities, using a repeated measures design. Three cohorts will be recruited: (1) young and healthy (n=35), (2) older and healthy (n=35), and (3) with spinal cord injury (n=35). Participants will complete 3 testing sessions using a custom-built shearing rig with integrated thermal plate, during which the posterior aspect of the heel will be exposed to a standardized mechanical stimulus to elicit repeated pressure and shear loading. The experimental condition of each session will be determined by the temperature of the thermal plate, which will be set to either 36 °C (no cooling), 24 °C (mild cooling), or 16 °C (strong cooling). Continuous measurements will include kinetic coefficient of friction (CoF) and skin blood flow (via laser Doppler flowmetry; 40 Hz). Pro- and anti-inflammatory biomarkers in skin sebum (via Sebutape), structural skin properties (via optical coherence tomography), skin conductance (in microsiemens) and ratings of thermal sensation, comfort, and acceptance (via Likert scales) will also be assessed before and after the shear stress protocol. Results: Recruitment began in January 2024. As of February 2025, 43 participants had been enrolled in the study. Data collection and analysis are ongoing, and published findings are expected to be available in early 2026. Conclusions: This analysis will help identify mechanisms of skin damage following repeated shear stress at the heel, furthering our understanding of superficial pressure ulcers. It will also establish physiological and perceptual thresholds for the protective effects of cooling from shearing-induced damage at the heel.

Background: Anxiety disorders are among the most common mental health disorders, affecting a significant portion of the population. However, conventional treatments, such as pharmacotherapy and psychotherapy, often have limited effectiveness and may lead to undesirable side effects. Consequently, there is a growing demand for new alternative treatments for anxiety disorders. Recent studies suggest that electroacupuncture may demonstrate therapeutic effects in managing anxiety by mediating nerve stimulation. Objective: This study is designed to assess the efficacy and safety of electroacupuncture in treating anxiety disorders through nerve stimulation. Specifically, it will involve stimulating the median nerve at the PC6 acupoint (Neiguan) and the vagus nerve at the TF4 acupoint (Shenmen of ear acupuncture). Methods: This study is a randomized, assessor-blind, three-arm, parallel-group clinical trial comprising the PC6 electroacupuncture group, TF4 electroacupuncture group, and a control group. Participants will include patients diagnosed with social anxiety disorder, panic disorder, agoraphobia, and generalized anxiety disorder. Eligible participants will be randomly assigned to one of the 3 groups, with each group containing 20 individuals. The electroacupuncture groups will receive treatments at the designated acupoints twice weekly for 8 weeks, totaling 16 sessions. The control group will receive usual care without any treatment interventions through the end of the study period. The primary outcome is the comparison of Hamilton Anxiety Rating Scale scores between the treatment groups and the control group. Secondary outcomes include scores on the Hamilton Anxiety Rating Scale, Beck Anxiety Inventory, Beck Depression Inventory-II, Patient Health Questionnaire-15, World Health Organization Quality of Life Assessment Instrument abbreviated version, Penn State Worry Questionnaire, Panic Disorder Severity Scale, and Leibowitz Social Anxiety Scale. Safety evaluation variables include the frequency of adverse events, vital signs, and suicide risk assessment. Exploratory variables include performance on the Emotional Reactivity Test, empathy quotient, and heart rate variability. Results: The first participant was enrolled on December 15, 2022. As of October 2024, a total of 60 participants have been fully registered, and the intervention is currently in progress. We expect the completion of this trial to occur within the year 2025. Conclusions: In this study, we will evaluate the safety and efficacy of electroacupuncture for anxiety disorders. By elucidating the therapeutic mechanisms of electroacupuncture through nerve stimulation, this study will provide clinical evidence to support the development of potential interventions for patients with anxiety disorders. Trial Registration: Clinical Research Information Service of the Republic of Korea KCT0008378; https://cris.nih.go.kr/cris/search/detailSearch.do/24503

Background: Older Chinese Americans are at high risk of dementia, yet they often do not access culturally relevant services/programs to reduce their risks due to issues such as language barriers and transportation. BrainHQ is a mobile-based, effective cognitive training program that can potentially address these barriers and delay cognitive decline in older Chinese Americans. Objective: We aim to evaluate the feasibility and acceptability of a mobile-based cognitive training intervention co-designed by older Chinese Americans and their adult children. Methods: We applied an experience-based co-design approach that leverages existing cognitive training features and older Chinese Americans’ prior knowledge, lived experiences, and social norms around dementia to co-develop a cognitive training intervention. We conducted an experience-based co-design workshop with Older Chinese Americans (n=10), and their adult children (n=4) to optimize the cultural and linguistic relevance of the cognitive training intervention. Participants used a journey map to brainstorm challenges they may experience when participating in the intervention. Then, the participants created prototypes of intervention components to address these challenges. Finally, we incorporated these prototypes into the co-designed intervention protocol. A total of 30 participants will be recruited into the intervention study and will be randomly assigned to the intervention or waitlist control group (2:1 ratio). The intervention group will complete the mobile-based cognitive training for between 10 and 15 minutes daily for 12 weeks. The primary outcomes are feasibility and acceptability. Global cognition, mental health, physical functioning, and quality of life will be assessed at baseline, 8, and 12 weeks. Results: This pilot trial received institutional review board approval (Pro00109934l) in November 2024. We enrolled the first participant in December 2024 and aim to complete enrollment by May 2025. We expect to complete all data collection by September 2025. We will analyze the data and report study findings by February 2026. Conclusions: This study leverages partnerships with academic, industry, and community stakeholders and provides the groundwork for a large-scale randomized controlled trial to test the efficacy of a mobile-based cognitive training intervention for older Chinese Americans. The co-design workshop served as a feasible, innovative approach to engage with the participants and improve the study design. These findings will enhance the culturally tailored delivery of cognitive training to older Chinese Americans and provide insights for broader implementation, improving their engagement in dementia research. Trial Registration: ClinicalTrials.gov NCT05355870; https://clinicaltrials.gov/study/NCT05355870

Background: Falls are a critical source of injury and hospitalization and leave many older adults unable to return home, especially in rural communities with limited access to health care and support services. Studying falls prevention among rural older adults is essential because they may face an increased risk of falls due to unique environmental factors, geography, and outdoor activities. Moreover, rural older adults may have limited awareness regarding fall-related risks and preventive activities. Objective: The objective of this scoping review is to explore the literature about falls prevention from the perspectives of older adults living within a rural context. This review protocol aims to identify the search parameters and methodology that will be used in the scoping review. Methods: This scoping review will be guided by Arksey and O’Malley’s 5-step methodological framework. We will search for relevant peer-reviewed English language literature from 5 databases: CINAHL, PubMed, Academic Search Complete, PsycINFO, and Scopus. The reference lists of relevant studies will be hand-searched to identify papers. Inclusion criteria (English language, peer-reviewed journal papers, original research, focusing on rural perspectives to support falls prevention, and published from January 2013 to December 31, 2023) will be used to determine the eligibility of the journal papers. The data from the included papers will be extracted using a standardized table and analyzed using thematic analysis. Results: This protocol was registered with the Open Science Framework on June 26, 2024. The scoping review’s data collection and analysis were conducted from September to December 2024. Results from the review will be distributed through publication in a peer-reviewed journal paper, conference presentation, webinar, and a rural community workshop. Conclusions: Understanding rural older adults’ perspectives of falls prevention is critical to supporting independence and healthy aging in rural communities. This review’s findings about falls prevention may have important implications for rural community leaders, policy makers, and health practitioners working to support falls prevention in rural communities.

Background: Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease that affects approximately 0.5% to 1% of the population in the United States and Northern Europe. Interstitial lung disease (ILD) is the most common and severe pulmonary manifestation of RA, collectively referred to as RA-associated ILD (RA-ILD). RA-ILD contributes significantly to morbidity and mortality and often presents with a variable clinical course. Although corticosteroids and disease-modifying antirheumatic drugs (DMARDs) remain the cornerstone of RA management, their role in RA-ILD is less clearly defined. In contrast, antifibrotic therapies such as pirfenidone and nintedanib, initially developed for idiopathic pulmonary fibrosis, are now being explored for their potential in treating fibrosing variants of RA-ILD. Despite increasing clinical use, no systematic review has comprehensively compared the safety and efficacy of antifibrotic versus anti-inflammatory therapies in chronic RA-ILD. Objective: This study aims to compare the impact of antifibrotic and anti-inflammatory therapies on lung function, radiologic progression, clinical outcomes, and safety in patients with chronic RA-ILD. Methods: This study will follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and is registered with PROSPERO (CRD42024583847). A comprehensive search of PubMed, Embase, and the Cochrane Library will be conducted for studies published between January 1991 and August 2024. Eligible studies will include adult patients (aged ≥18 years) with a diagnosis of RA and confirmed ILD based on radiological or histopathological findings who have been treated with either antifibrotic or anti-inflammatory therapies. The PECOS (Population, Exposure, Comparator, Outcome, Study Design) framework will be used to define inclusion criteria. The primary outcomes assessed in this review will include the following pulmonary function parameters: forced vital capacity, forced expiratory volume in 1 second, and diffusing capacity of the lungs for carbon monoxide. Anti-inflammatory therapies will be stratified into corticosteroids, conventional synthetic DMARDs, and biologic DMARDs to account for heterogeneity. The Cochrane Risk of Bias 2 (RoB 2) and Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) tools will be used for quality assessment, and GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology will be used to evaluate the certainty of evidence. Results: The literature search and screening commenced in August 2024, and data extraction is underway. The final results are expected by December 2025. Conclusions: This systematic review and meta-analysis will provide a comprehensive comparison of antifibrotic and anti-inflammatory therapies in the treatment of chronic RA-ILD. The findings will help inform clinical decision-making, support evidence-based treatment selection, and identify gaps in current research. By addressing both efficacy and safety, this review aims to guide future studies and improve patient outcomes for this complex and debilitating condition. Trial Registration: PROSPERO CRD42024583847; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024583847

Background: Speech and language biomarkers have the potential to provide regular, objective assessments of symptom severity in several neurological and mental health conditions, both in the clinic and remotely. However, speech and language characteristics within an individual are influenced by multiple variables that can make findings highly dependent on the chosen methodology and study cohort. These characteristics are often not reported adequately in studies investigating speech-based health assessment, which (1) hinders the progress of methodological speech research, (2) prevents replication, and (3) makes the definitive identification of robust biomarkers problematic. Objective: This study aims (1) to facilitate replicable speech research by presenting a transparent speech collection and feature extraction protocol and design checklist for other researchers to adapt and design for their own experiments and (2) to demonstrate in a pilot study the feasibility of implementing our example in-laboratory protocol that reduces multiple potential confounding factors in repeated recordings of healthy speech. Methods: We developed a collection and feature extraction protocol based on a thematic literature review to enable a controlled investigation of within-individual speech variability in healthy individuals. Our protocol comprises the elicitation of read speech, held vowels, and a picture description and extraction of 14 example features relevant to health. We collected speech using a freestanding condenser microphone, 3 smartphones, and a headset to enable a sensitivity analysis across different recording devices. Results: We collected healthy speech data from 28 individuals 3 times in 1 day (the “day” cohort), with the same schedule repeated 8 to 11 weeks later, and from 25 individuals on 3 days within 1 week at fixed times (the “week” cohort). Participant characteristics collected included sex, age, native language, and voice use habits. Before each recording, we collected information on recent voice use, food and drink intake, and emotional state. Recording times were also documented. Analysis relating to exploring within-individual variability within the day and week cohorts, as well as the device-type sensitivity analysis, is ongoing, with findings expected later in 2025. Conclusions: The wide variability in speech data collection, processing, analysis, and reporting in research on speech’s use in clinical trials and practice is the motivation for this paper and the development of the speech curation protocol design checklist. Increased, more consistent reporting and justification of study protocols is urgently required to facilitate speech research replication and translation into clinical practice.

Background: Gay and bisexual men who have sex with men (MSM) in the rural United States are less likely to test for HIV and sexually transmitted infections (STIs) and use pre-exposure prophylaxis (PrEP) compared to urban MSM. Given the challenges in building brick-and-mortar facilities serving the sexual health needs of MSM in rural communities, there is a need to evaluate digital engagement strategies. Combine is a smartphone app designed to provide HIV prevention information and resources to MSM that may be particularly well suited to support rural MSM. HealthMindr, an app from which Combine is adapted, has previously been shown to increase HIV testing and PrEP uptake among urban MSM. Because rural MSM face additional barriers to accessing HIV prevention services, a motivational interview (MI) focused on HIV prevention strategies might enhance the effectiveness of Combine to increase uptake of HIV testing, STI testing, and PrEP. Objective: This study aims to determine the effectiveness of the Combine app to increase HIV testing, STI testing, and PrEP initiation among rural cisgender MSM. We will also assess the effectiveness of 2 adjunctive interventions: the availability of free HIV and STI self-test kits and the offering of an MI. Methods: In this type 2 hybrid effectiveness-implementation randomized controlled trial, we will assess the effectiveness of Combine to increase HIV testing, STI testing, and PrEP initiation among rural MSM across the Southern United States. A total of 464 men will be recruited and randomized to 1 of the 4 arms. Participants in all 4 arms will have access to most app features (eg, health resources, quizzes, health care provider locators, and ordering free condoms and lubricants). Using a 2×2 factorial design, half (232/464, 50%) of the participants will be randomized to receive access to free at-home HIV and STI self-test kits and half (232/464, 50%) will be randomized to receive an MI. Participants will complete surveys every 6 months to allow for assessment of self-reported outcomes: app use, HIV testing, STI testing, and PrEP initiation over the 24-month follow-up period. Self-reported PrEP uptake will be verified by dried blood spot testing or uploading a photograph of a PrEP prescription. Results: Participant recruitment began in March 2024. As of July 2025, 395 participants have been enrolled and randomized. Recruitment is expected to be completed by December 2025. Conclusions: This trial will determine whether the Combine app increases HIV testing, STI testing, and PrEP uptake among rural MSM in the Southern United States. It will also provide critical information about the most effective strategies for implementing digital health interventions for rural MSM. Trial Registration: ClinicalTrials.gov NCT06205368; https://clinicaltrials.gov/study/NCT06205368

Background: Research indicates that many autistic adults are insufficiently active and overly sedentary. There is limited evidence on effective strategies to increase physical activity (PA) and reduce sedentary behavior (SB) in this population. Gamified mobile health (mHealth) interventions show promise for addressing these challenges by leveraging autistic individuals’ strengths in visuospatial learning and their affinity for digital gaming. Despite this potential, it remains unclear how well these interventions translate to real-world settings. This gap is compounded by the lack of community-based participatory approaches in the development of mHealth intervention for autistic adults. Objective: This study aims to (1) formulate gamification and behavior change strategies for the PuzzleWalk v2 app using a community-based participatory approach and (2) evaluate its feasibility and acceptability for increasing PA and reducing SB among autistic adults, including those with mild intellectual disability, in real-world settings. Methods: This study, consisting of 2 sequential phases, will be conducted entirely remotely: (1) online community-based design workshops to refine the PuzzleWalk gamified mHealth system with input from key autism stakeholders, including autistic adults and caregivers, and (2) an 8-week field deployment to assess real-world usability and engagement. In Phase I (completed), weekly workshops and usability testing focused on understanding autistic adults’ technology preferences, evaluating PuzzleWalk v1 and v2 prototypes, and incorporating stakeholder feedback into iterative app development (n=9). Phase II (in progress) will involve a single-arm clinical trial where approximately 70 participants will use the app alongside research-grade activity-tracking accelerometers to measure PA and SB. Outcome measures, including sedentary time, step counts, PA intensities, and app engagement (eg, time spent using the app), will be collected across 4 specific time points (ie, baseline and weeks 3, 5, and 8). Repeated measures ANCOVA will be performed to examine changes in participants’ objective levels of PA and sedentary time before, during, and after the intervention. Results: Phase I of the study, involving community-based participatory design workshops and usability testing, was completed in November 2024. Key autism stakeholders recognized the gamified PuzzleWalk app as a viable tool for enhancing motivation toward PA and SB changes among autistic adults. Data collection for Phase II, the field deployment, is currently underway and is expected to end in August 2025. As of July 2025, we had enrolled 69 participants in the study. The findings of these studies will be shared in a subsequent peer-reviewed publication. Conclusions: Results of the ongoing field deployment study (Phase II) will further clarify the app’s effectiveness and real-world applicability. Trial Registration: ClinicalTrials.gov NCT06566131; https://clinicaltrials.gov/study/NCT06566131

Background: Reducing blood pressure fluctuations during surgery is a key objective in improving patient outcomes. Although acupuncture has been suggested as a potential noninvasive intervention for blood pressure modulation, its effectiveness in reducing intraoperative fluctuations remains unclear. Objective: This study aims to investigate whether acupuncture can help stabilize blood pressure during surgery, particularly in women undergoing laparoscopic hysterectomy, a procedure known to cause marked hemodynamic changes during the early intraoperative phase. Methods: This is a prospective, single-center, randomized controlled clinical trial with a parallel-group design. Forty-eight adult patients scheduled to undergo a total laparoscopic hysterectomy are eligible for this study. Participants who provide consent will be randomly assigned in a 1:1 ratio to the acupuncture or placebo groups. They will be followed up for at least 14 days to assess the safety of the intervention, general anesthesia, and surgery. Researchers will compare the difference between the highest and lowest mean blood pressures from anesthesia induction to the postincision period as the primary endpoint. As secondary outcomes, systolic, diastolic, and mean blood pressures will be compared at each predetermined timepoint. The incidences of hypotension, hypertension, tachycardia, and bradycardia will be determined separately. The use of remifentanil at the early stage of surgery, rate of surgical discontinuation, and length of hospital stay will be assessed as surrogate indicators of stable general anesthesia and surgical procedures. For patient-reported outcomes, the Spielberger State-Trait Anxiety Inventory and EQ-5D-5L will be used to evaluate changes in anxiety and overall quality of life. This study may support the use of acupuncture as a complementary intervention to help maintain hemodynamic stability during laparoscopic hysterectomy. The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the Institutional Review Board of CHA Ilsan Medical Center (ICHA 2022-11-010; date of approval: January 03, 2023). Results: Recruitment began in October 2023 and is expected to continue until December 2025. The intervention and data collection procedures are proceeding without major difficulties, with a dropout rate of 11.4%. As of June 2025, a total of 35 participants have been successfully recruited and randomized. Final data analysis is scheduled for completion by March 2026, and the study results are expected to be published in December 2026. Conclusions: This trial will provide valuable evidence on the efficacy of acupuncture for stabilizing intraoperative blood pressure and supporting hemodynamic control during laparoscopic hysterectomy. Trial Registration: ClinicalTrials.gov NCT05720884; https://clinicaltrials.gov/study/NCT05720884

Background: Compassion fatigue and burnout among health care professionals are growing concerns, impacting the well-being of both providers and patients. Objective: This scoping review aims to map existing evidence on the levels of compassion satisfaction, burnout, and secondary traumatic stress among health care professionals while identifying factors influencing their professional quality of life. Methods: We will conduct a scoping review using established methods proposed by Arksey and O’Malley and Levac et al, also incorporating the recommendations of the Joanna Briggs Institute for scoping reviews and reporting guidelines. EMBASE, ERIC, PubMed, Science Direct, Scopus, and Web of Science will be searched from March 2019 to March 2024, with an update closer to the time of manuscript submission. Gray literature sources will also be searched. Publications that contain primary studies, systematic reviews, meta-analyses, and clinical guidelines addressing compassion fatigue and burnout prevention in health care professionals will be selected for inclusion. Extracted data items will include study characteristics, interventions for the prevention of compassion fatigue and burnout, measures of compassion satisfaction, burnout, and secondary traumatic stress, as well as the quality of reporting and methodology. Results: A narrative synthesis with summary tables will be used to describe our findings. The review is expected to be completed by December 2025, and the search strategy has been developed and pilot-tested. Conclusions: Our findings will help identify gaps in the literature with respect to compassion fatigue and burnout prevention strategies for health care professionals. This review will provide a comprehensive overview of current research, informing future interventions and policies aimed at improving health care professionals’ well-being and job satisfaction. Trial Registration: Open Science Framework r83cu; https://osf.io/r83cu

Background: There is growing concern about the mental health of students in higher education institutions (HEIs) across the United Kingdom. Increasingly diverse student populations, the legacy of the COVID-19 pandemic, and variations in policies and service provision across the 4 UK nations have highlighted the need for a comprehensive understanding of student mental health. Current literature remains fragmented, with limited synthesis comparing national contexts. This protocol outlines a scoping review to systematically map the evidence base, identify key research gaps, and inform future research priorities and interventions. Objective: The primary aim is to identify and map existing research on student mental health in UK HEIs. Specific objectives include exploring how student mental health is defined and measured, identifying risk factors, assessing support systems and interventions, and highlighting gaps in research across England, Scotland, Wales, and Northern Ireland. Methods: This scoping review will follow Joanna Briggs Institute methodology and be reported in line with PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Studies will be eligible for inclusion if they (1) were conducted in the United Kingdom; (2) involved students aged 16 years and older enrolled in HEIs; (3) addressed mental health–related outcomes, definitions, or interventions; and (4) were published in English from 2005 onwards. Excluded materials include gray literature not identified during database searching. A comprehensive 3-step search strategy will be used. Initially, APA PsycInfo and MEDLINE (Ovid) will be searched, followed by a broader search across Scopus, Web of Science (Core Collection), Child and Adolescent Development Studies, and the Cochrane Library. Reference lists of the included studies will be screened for additional sources. All citations will be managed using Covidence, and study selection will involve title/abstract screening and full-text review by independent reviewers. Data extraction will include information on study design, population characteristics, mental health outcomes, measures used, interventions, and key findings. Data will be presented in tabular and narrative forms and, where appropriate, descriptive content analysis will be used. Results: As of April 2025, preliminary searches and pilot screenings have been completed. The full database search and data charting phase will commence in June 2025. The final synthesis, analysis, and stakeholder consultation are scheduled between September and November 2025. The full review will be completed by December 2025, with dissemination activities planned through early 2026. Conclusions: This review will provide a comprehensive overview of student mental health research within UK HEIs. It will highlight the key national differences, emerging themes, and underresearched areas, supporting more targeted, evidence-informed policy and practice. Limitations include language and gray literature exclusions. Nonetheless, the findings are expected to make a timely and meaningful contribution to research and intervention strategies in UK higher education.

Background: Multiple sclerosis (MS) is a chronic, progressive, and neurodegenerative disease affecting more than 2.8 million people globally. Mobility impairments are among the most significant challenges faced by people with MS, leading to physical inactivity, deconditioning, and disability progression (for some, even irreversible disability). This negatively impacts mental health, social participation, and quality of life while placing a considerable economic burden on society. Exercise can improve mobility and mitigate disability progression, but facility-based options are often inaccessible, especially for those in remote areas. Telerehabilitation offers a promising alternative, but current systems are limited by complexity and hardware requirements. Objective: The PLATINUMS (Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis) project proposes an AI-driven telerehabilitation system to deliver accessible, cost-effective, and home-based exercise therapy for people with MS. Methods: The PLATINUMS project begins with working package (WP) 1, focusing on obtaining ethical approval and recruiting staff. Following this, WP2 involves a 4-week system feasibility and usability study (n=40) to assess and refine the digital platform. WP3 comprises a validity study (n=60) to evaluate remote mobility tests via the system, such as the Short Physical Performance Battery (SPPB), functional reach, and sit-to-stand tests, to ensure their reliability for use in WP4, the feasibility multicenter randomized controlled trial (RCT). The 10-week multicenter feasibility RCT will be conducted in MS centers across Denmark, Ireland, Israel, and Italy, with 96 participants varying in disability levels. The primary objective is to evaluate the efficacy of the AI-powered telerehabilitation system on mobility outcomes compared to usual care. Finally, WP5 will assess the cost-effectiveness of the telerehabilitation system by analyzing implementation costs, adherence, and use of health care. The PLATINUMS project aims to revolutionize exercise therapy for people with MS by demonstrating the feasibility, validity, and preliminary efficacy of the AI-driven telerehabilitation system. This approach addresses barriers such as accessibility, privacy, and standardization while promoting patient and therapist acceptance. Results: Funding for the PLATINUMS project was obtained in February 2024. WP2 data collection began in April 2025 across 4 European sites. WP3 is scheduled to launch in July 2025, with WP4 (the feasibility RCT) planned for January 2026. Initial WP2 results are expected by October 2025, with first publications anticipated in mid-2026. Conclusions: The PLATINUMS project is expected to generate critical insights into the feasibility, usability, and preliminary efficacy of an AI-based telerehabilitation system for people with MS. By leveraging widely available technology and real-time feedback, the system addresses key barriers to traditional rehabilitation. Findings from this protocol may inform future large-scale trials and support the broader implementation of digital health solutions in neurological rehabilitation. Trial Registration:

Background: The prevalence of type 2 diabetes mellitus (T2DM) is steadily increasing and has exceeded 20% in some rural Kentucky counties. In Kentucky, chronic diet-sensitive conditions and unhealthy behaviors are among the highest in the nation, with approximately 36.5% of adults with obesity and 13.3% diagnosed with T2DM, while only 15.3% meet physical activity recommendations, and 4.7% meet fruit and vegetable consumption recommendations. Family-based interventions can be used to promote health in rural communities that often comprise intergenerational households. Objective: The purpose of the study is to determine whether leveraging family units as sources of social support promotes nutritional and physical activity changes among those who are overweight or have obesity and are diagnosed with T2DM. Methods: This study consists of 3 phases (baseline, intervention, and postintervention). An overview of the study will be provided to interested participants, after which their consent will be sought. At baseline, demographic data, social support, physical activity, diabetes knowledge, diabetes self-management, dietary recall, obstructive sleep apnea, and sleep health, as well as social network data, will be collected using validated questionnaires. Anthropometric (weight, height, lean mass, and body fat) and T2DM-related (blood pressure, glycated hemoglobin A1c [HbA1c], total cholesterol, low-density lipoproteins, high-density lipoproteins, and triglycerides) clinical measures will also be obtained. During the intervention phase, participants will complete 6 months of medical nutrition therapy (MNT) alongside 1 member of their social network (eg, household member). In addition, participants will have the option to attend Dining with Diabetes program sessions that are offered at the county level through Cooperative Extension Service (Extension) agents. Follow-up data collection will include clinical measures, a dietary recall, and the assessment of participants’ stage of behavior change at 3, 6, 9, and 12 months postintervention. Results: This study was funded in November 2022 by the American Diabetes Association (ADA). Data collection started on September 1, 2023, and is projected to end in November 2025. We have enrolled a total of 48 participants in the study. Conclusions: T2DM is a growing problem, particularly among vulnerable populations in rural Kentucky. This study plans to leverage family units as sources of social support with MNT and nutrition education through the Dining with Diabetes program. If effective, this approach will inform future family-based interventions in rural communities. Trial Registration: ClinicalTrials.gov NCT06080425; https://clinicaltrials.gov/study/NCT06080425

Background: Antimicrobial resistance (AMR) is recognized as a global concern, with particularly severe consequences in low- and middle-income countries. Although it may occur naturally, it is also an anthropogenic problem linked to the irrational use of antibiotics in humans and animal husbandry and the use of pesticides in plant agriculture. Generally, data on AMR and evidence of effective and feasible multifaceted interventions are limited in many African countries. Objective: This study aims at (1) assessing baseline data on AMR pathogens in Burkina Faso and Ghana; (2) understanding perceptions and quantifying use of antibiotics among health care workers, communities, and livestock farmers; and (3) defining and refining an AMR intervention using a design thinking approach. Methods: This multidisciplinary study will be conducted in two rural districts and will consist of two phases. First, baseline data will be collected on AMR pathogens along dominant food production chains. extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli and Klebsiella pneumoniae will be selected as indicator mechanisms for AMR because of their high occurrence among animals and humans. The perception and understanding of AMR and antibiotic use among different stakeholders and community members will be assessed using epidemiologic and socio-anthropological methods. Qualitative methods will include participant observations, in-depth and key informant interviews, and focus group discussions. The quantitative part will consist of the development of an inventory of circulating antibiotics and a household survey. Second, key informant and in-depth interviews will be conducted with One Health stakeholders in preparation for the intervention development. Subsequently, multidisciplinary “design teams” will develop ideas for an intervention on AMR using a design thinking approach. Results: Data collection started in April 2022. The analysis of microbiological, anthropological, and socio-epidemiological data is ongoing in both countries. The intervention development has been initiated in Ghana but has not started yet in Burkina Faso. All results are planned to be submitted to peer-reviewed journals by December 2025. First, manuscripts will be published for each discipline. Afterward, the results of the 3 disciplines will be combined in multidisciplinary papers, and a publication of the evaluation of the intervention will follow. Conclusions: Owing to the multifactorial nature of AMR, different perspectives need to be considered to develop a holistic context-based intervention that is tailored to local needs. This study stands out in its combination of different disciplinary and epistemological perspectives following the One Health paradigm and taking a design thinking approach to develop an intervention. Thereby, collaboration across disciplines and social levels and a participatory bottom-up approach will be promoted to achieve a common understanding of problems and needs and to develop an accepted and efficacious intervention. The national AMR networks and policymakers will be continuously involved in the project.

Background: Mobile health (mHealth) technology has the ability to integrate personalized health management into patients’ daily routines. In prior investigations of mHealth apps for asthma, patient satisfaction and acceptability have been high. However, rigorous randomized controlled trials (RCTs) examining their effectiveness are sparse; the majority of mHealth asthma apps lack personalization and real-time feedback and fail to include at-risk pediatric populations, and many previous studies are not randomized. Objective: This full-scale RCT will examine the effectiveness of the Pulmonary Education and Asthma Knowledge Mobile Asthma Action Plan (PEAKmAAP), an interactive mHealth asthma action plan (mAAP) smartphone app, among adolescents compared to enhanced usual care (eUC). The study has 3 aims: (1) examine the effectiveness of PEAKmAAP in reducing asthma morbidity, as measured by the Asthma Control Test (ACT) score, health care use, medication use, and lung function; (2) examine the effectiveness of PEAKmAAP in asthma self-efficacy and medication adherence; and (3) examine the impact of sharing PEAKmAAP-generated data with the primary care provider (PCP) for a subset of enrolled subjects. We hypothesize that the PEAKmAAP groups will experience reduced asthma morbidity compared to the eUC group. Furthermore, we hypothesize that PCP data sharing is expected to enhance PCP prescribing patterns and that more adolescents in the Pulmonary Education and Asthma Knowledge Mobile Asthma Action Plan with data sharing (PEAKmAAP-DS) group will have sustained controlled at follow-up visits compared to PEAKmAAP alone or eUC. Methods: Using a 3-arm RCT lasting 12 months, we will assess the effectiveness of PEAKmAAP in reducing morbidity among 432 adolescents (age 12-20 years). The study population includes adolescents with uncontrolled symptoms who receive primary care at the Arkansas Children’s Hospital (ACH) or asthma care at ACH specialty clinics. At baseline, participants are randomly assigned to 1 of 3 groups: (1) PEAKmAAP group, (2) PEAKmAAP-DS group, and (3) eUC group using a smartphone app with daily non–asthma-related notifications. Study procedures will include baseline, 3-month, and 12-month in-person visits and telephone visits at 6 and 9 months. In-person visits will measure the ACT score, lung function, and self-efficacy; telephone visits will measure the ACT score. Participants will complete monthly online surveys to assess health care use and medication use. Results: Recruitment and data collection began in March 2019, and data collection concluded in May 2024. Full data analysis began in December 2024. Conclusions: This RCT aims to examine the effectiveness of a mAAP with real-time feedback and PCP data sharing. The study addresses existing gaps in knowledge regarding implementation of a mAAP for high-risk adolescents and has the potential to serve as a model for other populations at high risk for asthma. Trial Registration: ClinicalTrials.gov NCT03842033; https://clinicaltrials.gov/study/NCT03842033

Background: Assisted vaginal birth is a lifesaving procedure where health workers use special devices to expedite birth vaginally when some complications emerge, such as due to prolonged labor. When the use of assisted vaginal birth is possible and appropriate, it provides benefits over cesarean section. These benefits include shorter recovery, reduced hospital stays, lower risks of complications, cost savings, and greater likelihood of vaginal birth in future pregnancies. Despite these benefits, the use of assisted vaginal births has declined in recent years. Challenges remain on how to implement assisted vaginal birth effectively, equitably, and at scale in different health systems. Formative research is useful to understand local health system preparedness, acceptability, feasibility, and resource availability for designing and implementing health interventions. Objective: We developed a generic formative research protocol that can be used to design and implement interventions to optimize use of assisted vaginal birth in any setting and context. Methods: This formative research protocol is to be conducted in the setting where interventions to optimize assisted vaginal birth will be implemented. The formative research has three components: (1) document review, (2) readiness assessment, and (3) primary qualitative research. Document review will examine existing policy and guidelines, while readiness assessment will assess the service delivery context. The 2 components aim to identify potential barriers and facilitators to use of assisted vaginal birth. Primary qualitative research will involve women, families, community members, health workers, facility administrators, and policy makers. Interview questions are structured around potential interventions to optimize use of assisted vaginal birth. This protocol includes all the essential study instruments. Results: This is a generic research protocol that can be used by any stakeholder aiming to optimize assisted vaginal birth in any setting. Serving as a preparatory guide, it provides a structured approach for planning and implementing evidence-based and context-specific strategies aligned with best practices in maternal health care. No data collection or analysis has been conducted to date. Conclusions: This generic protocol can serve as a guide in conducting formative research as intervention preparation to optimize use of assisted vaginal birth. The results can inform the design and implementation of appropriate interventions from the perspectives of important stakeholders. Therefore, we recommend that trialists, clinicians, researchers, administrators, and policy makers use this protocol before implementation to understand local context and incorporate perspectives of key stakeholders to promote equitable, high-quality, and women-centered care.

Background: Acute respiratory infections (ARIs) are frequent reasons for medical consultations in general practice and can lead to unnecessary recontacts. Introducing new point-of-care (POC) polymerase chain reaction (PCR) diagnostic equipment may offer an attractive and efficient way of providing a more precise and exact microbial diagnosis. Successful uptake of POC PCR equipment could potentially lead to a reduction in recontacts with benefits for both staff and patients. However, introducing new diagnostic technology is a complex intervention and several contextual factors may impact the implementation. Objective: This study aims to evaluate the effect of POC PCR test availability in general practice on the subsequent (1) number of recontacts to the general practitioner (GP) for patients with symptoms of ARIs (primary outcome) and (2) hospital admissions, deaths, antibiotic prescriptions, health-related quality of life, GP and patient satisfaction, costs, cost-effectiveness, and contextual facilitators and barriers conditioning the implementation process (secondary outcomes). Methods: This study is a cluster-randomized, crossover, nonblinded superiority trial with a 1:1 allocation ratio between usual care (control) and POC PCR test availability (intervention). Questionnaire data are collected at day 0, 7, 14, and 28 after the initial contact (health-related quality of life, absenteeism and presentism among patients, and patient satisfaction) and after finalization of the study period (GP satisfaction). Data on recontacts, hospital admissions, redeemed antibiotic prescriptions, costs, and deaths will be retrieved from the Danish national registries. The implementation process will be evaluated based on data from interviews with users of POC PCR tests (i.e., GPs, staff, and patients) and from observations in the clinics in line with Medical Research Council guidelines. Results: As per the randomized crossover design carried out during September 2023 to March 2024 investigating a sample of 100 GP clinics, we expect to obtain an in-depth and multifaceted understanding of the effects of the availability of the POC PCR test equipment in general practice. Conclusions: This study will provide valuable information about the diagnostic conditions and possibilities in general practice and provide insights into the organization of primary health care. Trial Registration: ClinicalTrials.gov NCT06120153; https://clinicaltrials.gov/study/NCT06120153

Background: Fermented foods vary significantly by food substrate and regional consumption patterns. Although they are consumed worldwide, their intake and potential health benefits remain understudied. Europe, in particular, lacks specific consumption recommendations for most fermented foods. Objective: This project, which is under the framework of the Promoting Innovation Of Fermented Foods (PIMENTO) Cooperation in Science and Technology (COST) Action (CA20128), aims to develop a validated tool to quantitatively estimate fermented food intake across 4 European regions. Methods: The Fermented Food Frequency Questionnaire (3FQ) was designed to quantify fermented food intake in terms of frequency and quantity. Fermented foods were categorized into broad groups (eg, dairy, plant-based, meat, beverages) based on product classifications, ensuring that the foods included were genuinely fermented through ingredient analysis according to the International Scientific Association for Probiotics and Prebiotics consensus for fermented foods as a guide. For each main fermented food group, subcategories were determined after detailed discussions by a scientific expert panel that provided country-specific examples. For example, for hard cheeses, Parmigiano was chosen in the Italian version, and Graviera in the Greek version. The questionnaire was developed in English (universal version) and then translated into multiple languages using the back-translation method. Each version was pilot-tested for clarity, and data for the prospective validation were gathered. This included two key steps: (1) assessing repeatability by having participants retake the questionnaire after 6 weeks and (2) confirming accuracy by comparing 3FQ results against 24-hour dietary recalls from a subsample of participants. Statistical analyses will be used to confirm agreement between the methods. Representative sample calculations were performed for 4 groups by biological sex and age group (between 18 and 49.9 years and 50+ years). To ensure representative sample obtainment, participants aged 18+ years were recruited via the internet using multiple strategies, including social media platforms in all countries, snowball sampling, and potential supplementation with panels provided by the survey platform. Prior to all responses, participants were asked to provide informed consent and agree to data collection under ethical guidelines using a General Data Protection Regulation–compliant platform. Results: A representative sample of 1536 participants per European region was targeted, ensuring diversity in age and sex, with the goal of achieving a 60% response rate. A multilingual questionnaire was developed and pilot-tested for clarity. The upcoming steps will include final validation for accuracy and repeatability using 24-hour dietary recalls and specific statistical techniques of analysis to ensure reliability. Conclusions: The validated web-based 3FQ aims to address the current gaps in fermented food intake to help improve future research in this important area.

Background: Approximately 69% of Americans with spinal cord injury (SCI) have neuropathic pain. Research suggests that impairments in mental body representations (MBRs; ie, representations of the body in the brain) likely contribute to neuropathic pain. Clinical trials in adults with SCI, focused on restoring MBR, led to improvements in sensation and movement as well as neuropathic pain relief. Scales measuring aspects of MBR exist, but none of them assess SCI-related MBR impairments. Objective: As our first aim, we will generate items for a new MBR scale for adults with SCI (the SCI-BodyMap). As our second aim, we will assess the interrater reliability, test-retest reliability, concurrent validity, face validity, and utility of the SCI-BodyMap. Methods: Our preliminary work will encompass initial item generation by SB, an Italian physical therapist (PT) specialized in cognitive multisensory rehabilitation, which is a therapeutic approach that focuses on restoring MBR in adults with neurological disorders and chronic pain. Further item refinements will be carried out by Italian PTs (n=7) and Brazilian PTs (n=3) specialized in cognitive multisensory rehabilitation. In aim 1, American PTs or occupational therapists (n=8) and adults with SCI (n=8) will provide feedback on the SCI-BodyMap. Next, American PTs or occupational therapists (n=3) will administer the SCI-BodyMap to adults with SCI (n=3) and provide more feedback during an in-person visit. In aim 2, four assessors will administer the SCI-BodyMap to adults with SCI (n=30) for interrater reliability. The self-report items will be administered at 2 separate time points to assess test-retest reliability. We will also administer the SCI-BodyMap to uninjured adults (n=30) to identify whether healthy adults score statistically different on the scale than adults with SCI. We will assess concurrent validity through correlations between the MBR scale, the Revised Body Awareness Rating Questionnaire, and the Multidimensional Assessment of Interoceptive Awareness-2. Results: As of August 2025, we have enrolled 8 PTs or occupational therapists and 8 adults with SCI for aim 1 as well as 29 adults with SCI and 13 uninjured adults for aim 2. Conclusions: A reliable and valid MBR scale is needed to identify MBR deficits and evaluate intervention effects on MBR outcomes in adults with SCI. Improving MBR can lead to safer, more efficient day-to-day activities (eg, transfers); promote functional independence and quality of life; reduce neuropathic pain and spasms; and improve sensorimotor function.

Background: Various media are used to enhance public understanding about diseases. While mobile health apps are widely used, there is little proof for using such apps to raise awareness of skin diseases. Objective: We intend to develop an app, called DEDIKASI-app, to raise awareness of skin diseases, including leprosy. The study will explore baseline awareness, assess the app’s acceptance by community members and health care workers, and evaluate its effectiveness in enhancing awareness about skin diseases. Methods: The study will be conducted in four phases: (1) development of DEDIKASI-app, (2) questionnaire development for an awareness study, (3) acceptability testing, and (4) effect measurement of DEDIKASI-app. We will adopt design thinking methodology to develop the app, involving systematic reviews, expert consultations, focus group discussions, and validation of the questionnaire on skin disease awareness. We will recruit 50 members of the community for the awareness and acceptability study and 1 health care worker per community health center to assess their perception of the app. A pilot study will assess the acceptability of DEDIKASI-app among community members and health care workers based on various constructs, with responses categorized as positive, negative, or undecided. The validity and reliability of a newly developed questionnaire on skin disease awareness will be tested, with validity results analyzed qualitatively and reliability measured using Cronbach α. The effectiveness of DEDIKASI-app in improving community awareness will be evaluated through a randomized controlled trial, using total scores, means, and SDs for control and intervention groups. Statistical significance of awareness level changes will be determined by delta change (P value), with P<.01 considered significant. Results: This study received ethical approval from the Ethics Review Board of the Faculty of Public Health, Universitas Airlangga (160/EA/KEPK/2023) and was registered in the Indonesia Clinical Research Registry (INA-O8EX278). Funding for the field research was secured in the period of May 2022-December 2024 from NLR Indonesia and Erasmus University Medical Center. As of manuscript submission, phase 1 (app development) and phase 2 (questionnaire development) have been completed. Data collection for the randomized controlled trial has just finished and data analysis is ongoing, with publication of the study results expected in late 2025. Conclusions: Innovative approaches are required to enhance awareness in the community. This study will introduce new tools and insights to address the limited knowledge about detecting skin problems. Trial Registration: INA-CRR Indonesia Clinical Research Registry INA-O8EX278; https://tinyurl.com/ms3k5yvn

Background: With the availability of more advanced and effective treatments, life expectancy has improved among patients with metastatic breast cancer (MBC), but this makes communication with their medical oncologist more complex. Some patients struggle to learn about their therapeutic options and to understand and articulate their preferences. Mobile health (mHealth) apps can enhance patient-provider communication, playing a crucial role in the diagnosis, treatment, quality of life, and outcomes for patients living with MBC. Our team developed an app called My MBC Journey to focus on the collection of important information for patients with MBC between clinical encounters. Objective: This study will evaluate the usability and satisfaction of My MBC Journey, a mobile app designed for MBC, to inform future modifications. Methods: This mixed methods study will assess patient use and satisfaction with the My MBC Journey app to inform future app modifications and identify the barriers and facilitators to the app’s use for enhancing patient-provider communication. We will recruit a prospective, cross-sectional convenience sample of 25 patients with MBC and a sample of 15 members of the care team (ie, caregivers, nurse navigators, and medical oncologists). Applying iterative, convergent mixed methods, we will conduct qualitative, semistructured interviews with the patients and care team members. We also will collect quantitative data on usability through app analytics and standardized questionnaires (ie, the Mobile Application Rating Scale, the Mobile Application Rating Scale user version, and the System Usability Scale). Qualitative interviews will be audio recorded and analyzed using NVivo software to identify mHealth implementation themes. Results: The study’s results will inform future app design modifications and gauge preliminary effect size in support of future evaluations of the app’s efficacy in improving patient-provider communication. Conclusions: Our long-term goal is to improve patient-provider communication by developing mHealth apps that empower patients to collect and share clinically relevant, patient-reported information in a timely manner.

Background: Youth who are experiencing homelessness face a higher risk of HIV infection compared to their housed peers, and suicide and overdose remain the leading causes of death among homeless youth. Just-in-Time Adaptive Interventions (JITAIs) are gaining momentum for HIV prevention and substance use research. Yet, most interventions for homeless youth have not addressed modifiable real-time factors. Objective: This paper describes the development and implementation of a randomized attention-controlled trial to assess the efficacy of motivating youth to reduce infections, disconnections, and emotional dysregulation (MY-RIDE), a JITAI to improve HIV prevention and substance use in homeless youth. Methods: This study will enroll 320 homeless youth aged 18-25 years. The intervention was co-designed with homeless youth using the Information-Motivation-Behavioral Skills Model and consists of an individual nurse-led session about HIV prevention and 3 months of a JITAI with personalized messaging delivered by phone in real time in response to one’s current level of risk. Participants also had access to an on-demand nurse helpline through the app. Results: Institutional review board approval was obtained in the summer of 2024. Recruitment began in the fall of 2024 at shelters, drop-in centers, and other organizations that serve homeless youth. Participants complete a baseline survey and HIV/sexually transmitted infection (STI) testing and are provided with a smartphone with the intervention app. Follow-up surveys and HIV/STI testing are conducted at immediate, 3-, 6-, and 12-month time points post intervention to assess uptake of HIV prevention strategies and substance use reduction. A total of 192 are enrolled to date. Conclusions: The results of this study will determine whether MY-RIDE increases HIV prevention strategies and decreases substance use when compared to homeless youth in the attention control group. We will also evaluate if MY-RIDE impacts protective factors such as willingness to take pre-exposure prophylaxis medication and use of mental health and substance use services, and antecedents of risk such as stress, substance use urge, and substance use. Trial Registration: Clinicaltrials.gov NCT06074354; https://clinicaltrials.gov/study/NCT06074354

Background: In-hospital cardiac arrest (IHCA) remains a public health conundrum with high morbidity and mortality rates. While early identification of high-risk patients could enable preventive interventions and improve survival, evidence on the effectiveness of current prediction methods remains inconclusive. Limited research exists on patients’ prearrest pathophysiological status and predictive and prognostic factors of IHCA, highlighting the need for a comprehensive synthesis of predictive methodologies. Objective: This scoping review aims to synthesize and critically evaluate the quality and quantity of clinical features and machine learning (ML) models for predicting IHCA. The review will evaluate temporal characteristics, predictive and prognostic values of prearrest clinical features, and model performance metrics. Methods: This scoping review follows the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines and aims to synthesize studies that used ML algorithms to predict IHCA published between April 2009 and April 2024. We will conduct a comprehensive search using 4 major databases: PubMed, Web of Science, IEEE Xplore, and Embase. The inclusion criteria are peer-reviewed, English-language studies that explore ML applications for predicting IHCA in adult patients (aged ≥18 years). Exclusion criteria include review articles, preprints, non–English-language studies, and studies without specific ML metrics for IHCA prediction. Two independent reviewers will conduct the screening and data extraction using Rayyan for deduplication and ensuring study eligibility. Descriptive statistics will be used to summarize the data, and a narrative synthesis will provide insights into the clinical features used in the models, the performance metrics, and any gaps in the literature. Results: A total of 2479 records were identified between April 2009-April 2024. After removing duplicates and conducting screening, 16 studies have been included in the review. Data extraction and synthesis are ongoing and are expected to be completed by June 2025. The anticipated results from this review will provide a comprehensive overview of the clinical predictors of IHCA used in ML models, including commonly reported clinical features such as vital signs, biomarkers, and comorbidities. We expect to highlight variations in data quality and quantity across studies, which may influence model performance. Conclusions: This study will contribute to advancing ML applications for IHCA prediction by addressing data challenges and promoting standardization to improve the clinical decision-making process. The results of this review are expected to inform future studies; promote consistency in the reporting of clinical features; and, ultimately, enhance the decision-making process in clinical settings, potentially leading to better outcomes for patients experiencing IHCA.

Background: In Canada, the Indigenous population is the youngest and fastest growing, yet ongoing health disparities for Indigenous peoples are widely recognized. There is a concerning lack of research on childhood disabilities and health conditions in Indigenous populations in Canada. For children with disabilities and chronic health conditions, ongoing access to rehabilitation services, such as occupational therapy, physical therapy, speech-language pathology, and audiology, is critical in promoting positive health and developmental outcomes. Elders and the Peter Ballantyne Cree Nation health services board have guided a critical priority for addressing access challenges to pediatric rehabilitation in 3 specific northern Indigenous communities. Objective: The purpose of this manuscript is to outline the protocol for a community-directed needs assessment and subsequent development of a multidisciplinary pediatric rehabilitation service in 3 specific northern Indigenous communities. Methods: The study involves 3 phases. In phase 1, the needs assessment process was led by 2 physiotherapy clinician researchers and 2 graduate students working with health care professionals in pediatric speech-language pathology, audiology, physiotherapy, and occupational therapy with experience in both private and public health entities. The process consisted of multiple parts, which included a community-led request, a preliminary literature review, survey development, interview guide development, communication and feedback with health care professionals, a test phase with pediatric family members, and finalization of the survey and interview guides for deployment. In phase 2, the findings from phase 1 will inform the codevelopment of a pilot hybrid-care, interprofessional pediatric rehabilitation clinic for each of the communities. In phase 3, a stakeholder meeting will take place to facilitate knowledge sharing and open discussion regarding the implementation of phase 2 as well as considerations for the sustainability of this model of care. Results: The final survey was multidisciplinary, with 6 content areas covered in 15 items. Guides for 1-on-1 interviews and sharing circles included 10 questions for community members and 12 questions for health care providers. Participant recruitment began in April 2024. Final results are anticipated in early 2026. Conclusions: This manuscript details the process of a community-directed needs assessment, which will inform the development and implementation of a model of care for pediatric rehabilitation services. Our process was driven by a request from the community for a needs assessment and emphasized the involvement of key stakeholders early and often during assessment development. A clear purpose of the project was identified with community direction. We used multidisciplinary inputs from both public and private sectors and maintained clear goals during our survey question design process. This study aims to inform the codevelopment and implementation of an interdisciplinary, hybrid model of pediatric rehabilitation care for remote First Nation communities, ultimately leading to improved access to patient- and family-centered care for pediatric rehabilitation.

Background: Electronic health records (EHRs) have been linked to information overload, which can lead to cognitive fatigue, a precursor to burnout. This can cause health care providers to miss critical information and make clinical errors, leading to delays in care delivery. This challenge is particularly pronounced in medical intensive care units (ICUs), where patients are critically ill and their EHRs contain extensive and complex data. Objective: We propose to study the effect of an information visualization dashboard on ICU providers’ cognitive fatigue in 4 major US medical centers. In this randomized controlled trial, we will compare 2 leading EHRs with a visualization dashboard–based EHR called AWARE. Methods: This crossover randomized trial will collect physiological and objective data using a screen-mounted eye-tracking device to assess cognitive fatigue among ICU providers. The study will involve 120 ICU providers from 4 US medical centers, with each site using its institutional EHR as the control and the AWARE EHR as the intervention. Participants will be randomly assigned to use either their institutional EHR or the AWARE EHR first, followed by the other EHR, with the order of EHR use and patient case order randomized by the study team. The AWARE tool is designed to integrate within an existing EHR system and provides clinical support tools, such as the ability to trend data points from body systems at a glance. Data analysis will include eye-tracking metrics, performance measures, and validated surveys to evaluate EHR usability and its impact on clinical decision-making. Primary outcomes include the number of cognitive fatigue instances per patient case, time to complete each case, overall usability of the session, number of mouse clicks per case, provider performance scores from questions asked during each patient case, and perceived usability of each EHR. Secondary outcomes include the number of eye fixations per patient case and perceived workload of each EHR. Results: This EHR usability study was funded in 2021 and initiated in 2022, with a completion date of 2025. Data collection began in August 2023. As of now, 3 of the 4 study sites have completed data collection, with a total of 113 completed sessions thus far. Data collection is ongoing at the fourth site. Preliminary analysis is ongoing, and we expect to begin publishing results in late 2025. Conclusions: Findings from this research may inform improvements in EHR interface design and usability, which may enhance provider performance, streamline care delivery, and improve patient safety outcomes. Clinical Trial: ClinicalTrials.gov NCT05937646; https://clinicaltrials.gov/study/NCT05937646

Background: Cancer screening nonadherence persists among adults who are deaf, deafblind, and hard of hearing (DDBHH). These barriers span individual, clinician, and health care system levels, contributing to difficulties understanding cancer information, accessing screening services, and following treatment directives. Critical communication barriers include ineffective patient-physician communication, limited access to American Sign Language (ASL) cancer information, misconceptions about medical procedures, insurance navigation difficulties, and intersectional barriers for multiply marginalized individuals. Objective: This randomized controlled trial addresses these barriers by implementing the first videoconference-based study of ASL-fluent community health navigators (ASL-CHNs) to improve cancer screening adherence among adults who are DDBHH. The study tests whether ASL-CHN intervention results in greater adherence to cancer screening guidelines, improved patient-physician communication ratings, and increased cancer knowledge compared to standard care. Methods: The study uses a videoconference-delivered, block-randomized design stratifying 200 participants who are DDBHH by age and sex, with 100 participants assigned to the ASL-CHN intervention and 100 to standard care. All participants are confirmed as nonadherent to at least 1 of 5 age-appropriate cancer screening guidelines recommended by the United States Preventive Services Task Force for breast, cervical, colorectal, lung, and prostate cancers. Recruitment occurred nationwide through multiple strategies including prior study participants, community partners, and major community events. The intervention arm receives support from specially trained ASL-CHNs over several months, accommodating lengthy scheduling processes for cancer screenings. Primary outcomes measure completion of age- and risk-appropriate cancer screening, with prostate cancer focusing on shared decision-making participation. Secondary outcomes assess patient-physician communication using the validated National Cancer Institute’s Health Information National Trends Survey (NCI-HINTS) Patient Centered Communication questionnaire in ASL. Tertiary outcomes examine cancer knowledge through validated measures. The analysis uses intent-to-treat methodology using multivariable logistic regression, accounting for potential clustering effects and anticipated 25% attrition. Results: As of August 2025, more than 75% of the target enrollment has been achieved. Preliminary data indicate that the intervention group is consistently outperforming the standard care group in cancer screening adherence, supporting the study hypothesis that ASL-CHNs are effective in promoting cancer screening adherence among previously nonadherent participants who are DDBHH. Conclusions: The ASL-CHN intervention represents an accessible, scalable solution for reducing cancer screening disparities. By combining personalized navigation with ASL-fluent community health support through videoconferencing, this intervention addresses limitations of previous screening programs that lacked accessible support. If successful, the ASL-CHN model could provide health care providers with a practical, recommendable option for patients who are DDBHH requiring navigator support that can be done remotely through videoconferencing, potentially improving early detection rates and reducing cancer mortality in this underserved population while advancing accessible care delivery. Trial Registration: ClinicalTrials.gov NCT06492993; https://clinicaltrials.gov/study/NCT06492993

Background: In the United States, cancer is more prevalent in racial and ethnic minority groups and in rural-dwelling and low-income people. Compared with White people of non-Hispanic descent, Black and African American people have higher cancer mortality and Hispanic people are more likely to be diagnosed with infection-related cancers. In addition, people who live in persistent poverty areas are more vulnerable to cancer mortality. Tailoring health information technologies (HITs) can help bridge health inequities by providing these populations with relevant health information and cancer care. Cultural tailoring in health care involves adapting interventions to reflect a population’s values, history, and attitudes that influence behavior. Objective: The goals of the current study are as follows: 1) to understand what elements of tailoring HITs are most effective among different underserved populations, 2) to identify ways of incorporating these elements to improve the acceptability and effectiveness of technology-based interventions, and 3) to develop a framework to tailor HITs to underserved populations and improve engagement and acceptability. Methods: A scoping review will explore how HITs have been culturally tailored to underserved populations using PubMed, Scopus, and Web of Science database searches. Our search strategy will include terms and medical subject headings associated with the categories of cancer, HITs, tailoring, and underserved populations. We will also perform a snowball search of the references of included studies. We will include quantitative and qualitative peer-reviewed, English-language studies from the United States that examine efforts to tailor HIT interventions to improve their acceptance, use, and usability among underserved populations. Predefined inclusion and exclusion criteria will be applied for study selection. For each included study, we will extract the following data: study design, cancer type, underserved population of interest, details of the technology used, study methods, sample size, study outcomes, user acceptability, and tailoring and targeting strategies. The data will be summarized descriptively and analyzed thematically. Results: Preliminary searches following this strategy yielded a total of 784 citations (after removing duplicates) that will each be reviewed by at least 2 reviewers for inclusion. This protocol was submitted before data collection. The search strategy, citation screening, and data extraction will commence in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines and the published protocol. Findings will be expected by the spring of 2026. Conclusions: There is a need to develop more accessible HITs for underserved populations. This scoping review will inform researchers, providers, and developers working on cancer-specific HITs for underserved populations, such as racial and ethnic minority groups, rural-dwelling residents, and low-income populations. By summarizing evidence on tailoring strategies by population and delivery mode, the review aims to support the development of more effective and acceptable technologies.

Background: Sarcomas are rare cancer with a heterogeneous group of tumors. They affect both genders across all age groups and present significant heterogeneity, with more than 70 histological subtypes. Despite tailored treatments, the high metastatic potential of sarcomas remains a major factor in poor patient survival, as metastasis is often the leading cause of death. Currently, metastatic risk assessment relies mainly on histological grading; yet, this method has limitations due to the disease’s heterogeneity. Advances in genomic and transcriptomic research have identified potential molecular signatures, but these approaches lack reproducibility and prognostic reliability. Therefore, new biomarkers are essential for improving risk prediction and therapy adaptation. Recent studies highlight that sarcoma cells secrete extracellular vesicles, particularly small extracellular vesicles (sEVs). These nanovesicles, abundant in bodily fluids such as blood, urine, and saliva, play a crucial role in tumor development, growth, and metastasis. sEVs contain proteins and nucleic acids that mirror tumor characteristics. Given their presence in blood, sEVs offer a promising avenue for noninvasive molecular cancer analysis via liquid biopsy. Preliminary studies in Ewing sarcoma have shown substantial alterations in sEV-derived transcripts, underscoring their potential in tracking disease progression and treatment efficacy. Objective: This study aims to investigate whether sEVs can serve as reliable biomarkers for monitoring sarcoma progression and predicting recurrence risk. Methods: This prospective, multicentric pilot study will enroll adult patients diagnosed with localized or metastatic liposarcomas, leiomyosarcomas, or undifferentiated pleomorphic sarcomas at 3 French cancer centers. The study’s primary goal is to quantify sEVs and analyze their protein and RNA content in the blood of patients with localized or metastatic sarcomas before and after the treatment. sEVs will be isolated from plasma samples, and protein and microRNA concentration will be determined. Research will last, on average, 6 months for patients with localized sarcoma and 4 months for patients with metastatic sarcoma. Results: We expect to identify differences in exosome levels based on disease stage and observe correlations between exosome dynamics and treatment response. If confirmed, these findings could establish sEVs as noninvasive biomarkers for monitoring therapy effectiveness and disease progression in patients with sarcoma. Conclusions: This study could establish a novel, noninvasive biomarker for sarcoma prognosis and treatment monitoring. If successful, a nationwide study will be launched to confirm findings in a larger patient cohort, potentially revolutionizing sarcoma management and improving patient outcomes. Clinical Trial: ClinicalTrials.gov NCT03800121; https://clinicaltrials.gov/ct2/show/study/NCT03800121

Background: Youth in the United States are experiencing rising rates of anxiety, depression, and other mental health challenges, yet many remain underserved due to systemic barriers such as poverty, limited access to care, and shortages in the mental health workforce. Schools and primary care clinics are trusted, community-based settings that offer strategic opportunities for early identification, prevention, and intervention. As part of a public health approach, integrating digital mental health tools into these settings can support broad access, enhance mental health literacy, and promote help-seeking behaviors among all students. When co-designed with youth and embedded within existing care systems, these tools offer a scalable, proactive solution to support well-being across diverse school-aged populations. Objective: This protocol describes the design and implementation of a stepped-wedge clinical trial to evaluate the Connected for Wellness mobile app, a youth- and caregiver-facing digital mental health intervention. Developed using participatory informatics and human-centered design principles, the app provides culturally relevant content in English and Spanish. Features include self-guided wellness activities, well-being screeners, psychoeducational videos, and localized service directories. Machine learning algorithms personalize content recommendations based on user inputs and behavioral patterns. Methods: This trial uses a stepped-wedge cluster randomized design across 20 community-based sites (10 high schools and 10 primary care clinics) in 2 counties in California. These counties were selected for their high proportions of underserved youth populations. All youth aged 13 to 22 years and their caregivers will be invited to access the app. Sites are randomized into 2 implementation waves. The app is introduced site-wide as a universal public health intervention supported by on-site navigators and peer ambassadors. The primary outcomes are derived from a cascade-of-care framework, including identification of mental health need, referral to services, initiation of services, and engagement (defined as ≥3 treatment visits). Data will be collected via anonymous in-app analytics, monthly World Health Organization–Five Well-Being Index assessments, and deidentified electronic health and administrative records. Generalized linear mixed models will be used to evaluate differences in cascade outcomes between pre- and postimplementation phases while accounting for clustering and site-level variability. Results: As of May 2025, the mobile app has been finalized, institutional review board approvals have been secured, and all study sites have been recruited. Participant recruitment is projected to begin in August 2025. Data collection and initial analyses will begin in early 2026, with preliminary findings expected by October 2026. Conclusions: This study tests a novel digital health intervention integrated into trusted care systems. If effective, the Connected for Wellness mobile app may serve as a scalable strategy to reduce disparities in mental health care access and engagement for youth across the United States. Trial Registration: ClinicalTrials.gov NCT06122688; https://clinicaltrials.gov/study/NCT06122688

Background: Needs assessments in patients with juvenile idiopathic arthritis (JIA) have revealed a need for disease information, self-management skills, and peer support. We previously developed and tested the acceptability of an in-person and videoconference-based self-management program (SMP) to address these needs. Objective: The aim of this pilot randomized controlled trial (RCT; the VISTA-JIA trial) is to evaluate the feasibility and preliminary effectiveness of a virtual group-based SMP for adolescents with JIA in comparison to a waitlist control group. Methods: A total of 100 participants with confirmed JIA (aged 12-17 years) will be recruited from 5 Canadian pediatric rheumatology centers and randomized 1:1 to the intervention or waitlist control groups. Adolescents in the intervention group will receive the virtual SMP. Those randomized to the control group will receive standard of care alone and will later be eligible for the SMP. The SMP includes JIA disease education, self-management strategies, and peer support. Four 60- to 90-minute sessions will be conducted over 8 weeks with a group size of 4-6 participants. The primary feasibility outcome will be adherence to the SMP (defined as completion of all 4 sessions by at least 80% of participants). Other secondary feasibility outcomes will include recruitment and withdrawal rates, the proportion of completed questionnaires, engagement and satisfaction with the SMP measured through a semistructured virtual interview, and intervention fidelity (consistent content and technology delivery). Secondary preliminary effectiveness outcomes will be assessed by completing 5 validated questionnaires at pre- and postprogram time points: (1) the Medical Issues, Exercise, Pain, and Social Support Questionnaire to assess perceived ability to manage JIA (self-management); (2) the Children’s Arthritis Self-Efficacy Scale to assess self-efficacy; (3) the Pediatric Quality of Life Inventory 3.0 Rheumatology–Teen Module to assess health-related quality of life; (4) the PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference Scale to assess pain interference; and (5) Readiness for Adult Care in Rheumatology to assess transition readiness. Descriptive statistics and nonparametric tests will be used to analyze the data. Results: The study setup is complete at all centers, including training of the facilitators, revising and finalizing education sessions, participant’s handout guide, and fidelity checklist. Recruitment began in January 2024 and is expected to conclude by December 2025. Feasibility outcomes, including adherence and engagement, as well as preliminary effectiveness, will be analyzed post intervention. Conclusions: This is the first evidence-based, virtual, interactive, group-structured JIA SMP in Canada. This SMP will address needs for disease information, self-management skills, and peer support in adolescents with JIA. The results of this pilot study will inform a full-scale RCT focused on the efficacy and cost-effectiveness of the program with the goal of integration in routine clinical practice across Canada. Trial Registration: ClinicalTrials.gov NCT06184100; https://clinicaltrials.gov/study/NCT06184100

Background: Substance use rates among sexual minorities are disproportionately greater than that of their heterosexual counterparts. Minority stress theory posits that one explanation for disproportionate substance use in sexual minority populations is a result of increased social stress associated with holding a minoritized identity. This minority stress has been linked to a myriad of negative mental health outcomes, including alcohol and drug use. In addition, emerging research has begun to demonstrate links between minority stress and stress physiology dysregulation. While animal and human models have demonstrated links between stress physiology dysregulation and substance use outcomes, to date, no studies have examined the role that stress physiology plays within a minority stress framework in predicting substance use among sexual minorities. The Queer Health Study was designed to explore the longitudinal links among minority stress, stress physiology (specifically, allostatic load, the cumulative “wear and tear” on the body and brain as a result of chronic stress), and substance use. Objective: This study aims to assess the feasibility of collecting longitudinal data to explore the temporal links between minority stress processes, allostatic load, and drug and alcohol use, as well as to obtain estimates of effect size to determine the appropriate sample size necessary to conduct a fully powered longitudinal study. Methods: This feasibility study is a 3-wave longitudinal design consisting of a self-report survey, researcher-assisted Timeline Followback to assess for drug and alcohol use, and blood and anthropometric data collection to measure allostatic load at each of the time points. A total of 40 ethnically and racially diverse sexual minority adult participants (aged 18-60 years) will be enrolled. Results: The study received University of Houston institutional review board approval on July 31, 2023 (STUDY00004277). Recruitment began in June 2024. As of February 2025, the initial sample of 46 participants completed the time 1 visit, and time 2 visits are ongoing. We estimate that all study activities will be completed by July 2025. Conclusions: Results can inform the development of targeted prevention and treatment interventions. In addition, this research will provide an innovative framework for exploring diverse risk and resilience factors impacting addiction in this at-risk population. Ultimately, results have important implications for public health and have the potential to reduce the many dire economic and health consequences of drug use and addiction.

Background: Abdominal pain is a common reason for children to attend the Emergency Department (ED) with acute appendicitis being the most common surgical cause. Various clinical prediction scores (CPSs) have been developed to assist in determining the risk of appendicitis; however, CPSs have been inadequately validated in children and haphazardly adopted in Australia and New Zealand (ANZ) EDs. Objective: This study aims to compare and validate various CPSs for diagnosing pediatric appendicitis in children presenting to ANZ EDs. Methods: This prospective multicenter observational study across 10 ANZ EDs is recruiting children 5-17 years presenting to participating EDs with acute right-sided or generalized abdominal pain lasting ≤7 days and clinician suspicion of appendicitis. CPSs will be calculated by the study team from clinician-recorded data and clinician gestalt recorded on a visual analog scale. Accuracy of CPSs will be assessed by the area under the receiver operating characteristic curve and proportions correctly identified as either low-risk or high-risk based on the CPSs published cutoffs. The final diagnosis of appendicitis will be confirmed on histopathology, and the absence of appendicitis confirmed by telephone, email, or a combination of both to follow up for those discharged directly from ED. Results: This study received funding in July 2023 and started enrolment in August 2023. As of October 2024, we have enrolled and completed follow-up on 1227 participants with an expected end date in mid-2025. Conclusions: This study aims to determine the best-performing CPS for diagnosing pediatric appendicitis in ANZ EDs. Implementation of this CPS in ANZ EDs has the potential to reduce health care costs, rationalize the use of health care resources, and improve the management and outcomes of childhood appendicitis. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622001293752; https://tinyurl.com/242wwenx

Background: Miscommunication in health care is a major source of poor health outcomes, complaints about health care professionals, and poor patient satisfaction. Recordings from real-life consultations provide valuable data for communication research and education. Additionally, recordings from simulation-based education of health care students can provide valuable data for health care education research. Objective: The Digital Library is a data repository supporting high-quality health care communication research. This is the single-source citation for all projects that use the Digital Library in Australia. Methods: This protocol outlines the logistics and consent process for recording and safely storing the recordings of health care consultations and simulation-based education. The processes are outlined for primary health care settings and health care educational settings as well as for health care narratives from consumers. The repository will be used to answer research questions about health care communication and provide a valuable resource for health care education. Results: Data collection for the Digital Library commenced in 2023 and is ongoing at the time of submission of this protocol. The Digital Library has been approved by Monash University’s Human Research Ethics Committee. Conclusions: The Digital Library will provide a national resource for the study of health care communication in community settings, general practice, and other environments. The health care narratives may be a valuable resource for sharing the patient perspective when living with different conditions. The research that uses this repository will be shared through regular academic channels as well as the community-based dissemination strategies of the National Centre for Healthy Ageing.

Background: The effects of climate change on mental health are becoming widely recognized. Mental health can be impacted through direct and indirect exposure to natural hazards, as well as through the overarching awareness of climate change and the resultant environmental decline—the latter is termed eco-anxiety. Exposure to natural hazards also increases eco-anxiety, further compounding mental health impacts. Young people are especially vulnerable to the mental health impacts of climate change and have higher rates of eco-anxiety than other age groups. Those in rural areas are also more likely to be impacted by natural hazards, further underscoring the need to support this population. To date, there remains scant evidence regarding how to support young people with eco-anxiety, and few interventions, especially for children, have been evaluated. There is a need for further research to inform treatment for young people for climate change–related distress. Objective: This study pilots a novel group-based mental health and resilience intervention in relation to eco-anxiety. Specifically, this project aims to explore the acceptability, feasibility, and clinical utility of a group-based eco-anxiety intervention. Methods: The project is an exploratory pilot assessing the acceptability, feasibility, and clinical utility of a group-based intervention using a pre-post design with a single group. A minimum sample of 12 children aged 10-14 years located in a rural area and with exposure to at least one natural hazard will be enrolled in this study. In order to assess clinical utility, changes from preintervention to postintervention in distress, resilience, and climate emotions will be assessed. To do so, children will complete measures of psychological distress (subjective units of distress, Depression Anxiety Stress Scale-21–youth version), climate emotions, and resilience (Resilience Scale for Children-10) before and after the intervention. Acceptability will be assessed post intervention through a series of Likert scale and open-ended questions. Feasibility will be assessed through enrollment and the proportion of participants completing the full intervention. Eligible children will take part in a novel 5-module group-based intervention designed to build resilience, promote nature connectedness, build social support, and foster meaning-focused coping. Results: This study has received ethics board approval by the University of New England’s Human Research Ethics Committee (HE23-080). This study will be conducted from late 2024 to 2025. As of March 2025, 28 children have been enrolled in the study. Conclusions: Rural children and young people are an especially vulnerable population for the mental health impacts of climate change. To date, the evidence base for interventions for treating eco-anxiety remains sparse, especially for young people and children who typically have higher rates of eco-anxiety than older age groups. This study will provide preliminary evidence of a group-based treatment for children and adolescents experiencing eco-anxiety that can inform practitioners. Trial Registration: Australia and New Zealand Clinical Trials Registry ACTRN12624001287527; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=388545

Background: Kidney replacement therapy (KRT) is needed by patients with kidney failure to eliminate metabolic waste. When kidney transplantation is not feasible, hemodialysis (HD) is performed. Hemodiafiltration (HDF) provides a better solute clearance than conventional HD due to its higher convective dose. The clearance performances of HDF also depend on the type of dialysis membrane used. Polysulfone (PS) membranes have been used since 1965 due to their excellent resistance and biocompatibility. However, the newer generation of polymethylmethacrylate (PMMA) membranes offers comparable convective capacity with reduced albumin loss. Objective: The forthcoming study aims to compare the solute clearance of postdilution HDF using PMMA versus PS dialyzer membranes in patients with kidney failure requiring long-term HD. Methods: The literature search will use databases including PubMed, Scopus, Web of Science, Embase, and Cochrane. Two independent reviewers will select studies and assess their quality. Pooled estimates of relevant factors will be computed via a random-effects model using Stata/BE 18 (StataCorp) software. The reporting of findings will adhere to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Results: The search and screening for the systematic literature review are expected to be completed in May 2026. Data extraction, quality appraisal, and subsequent data synthesis will begin in June 2026. The review should be completed by October 2026, and the study results will be published in 2027. Conclusions: Dialyzer membrane clearance determines HD quality. Nevertheless, many middle uremic molecules are poorly cleared with conventional HD. Consequently, HDF was invented to improve their clearance. Among the most widely used dialyzer membranes, PS and PMMA are used in the newer generation of HDF. Nevertheless, no available systematic reviews have compared the efficacy of the 2 dialyzer membrane materials. Although no ideal dialyzer can efficiently remove all types of uremic toxins while retaining essential elements, improving solute clearance should benefit patients. This information could help clinicians determine which membrane to use in HDF. Trial Registration: PROSPERO CRD42024603277; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024603277

Background: Black and Latino men are at increased risk for poor diabetes health outcomes but are underrepresented in lifestyle interventions for weight loss and diabetes prevention. Although relatively few men participate in the National Diabetes Prevention Program (NDPP), it remains the most widely available evidence-based approach to type 2 diabetes prevention in the United States. Thus, an NDPP tailored to Black and Latino men has the potential to address prior limitations of NDPP implementation and reduce gender, racial, and ethnic diabetes disparities. It also provides an opportunity to define a population for targeted outreach and evaluate the reach of our recruitment methods and interventions. Objective: We tailored the US Centers for Disease Control and Prevention Prevent T2 curriculum for the NDPP for Black and Latino men, called Power-Up, and will evaluate its effects in comparison to standard mixed-gender NDPP groups via virtual delivery. The primary aim of the project is to assess the effect of Power-Up versus NDPP on weight loss among men with prediabetes. The secondary aim is to compare the engagement and retention of men with prediabetes in Power-Up versus NDPP. We will also examine the reach of our recruitment methods and engagement in our screening, consenting, and assessment procedures prior to the point of randomization. We hypothesized that men randomized to Power-Up would achieve greater percent weight loss from baseline at 16 weeks (end of Core sessions) and 1 year (end of Maintenance sessions) than men randomized to standard, mixed-gender NDPP. Power-Up is also expected to have better engagement and retention. Methods: Using the electronic health record (EHR) systems of a large academic medical center and a network of small to medium independent primary care practices throughout New York City, we identified Black and Latino men who met eligibility criteria for NDPP and enrolled them in a randomized controlled trial in which they were assigned 1:1 to receive Power-Up or the standard, mixed-gender NDPP over 1 year via online videoconferencing. Coaches delivering these interventions were trained according to the standards for the NDPP. Power-Up will be delivered by men coaches. Weight will be collected with home-based electronic scales for primary outcome analyses. Engagement will be assessed by session attendance logs. Results: We identified 11,052 men for outreach based on EHR data, successfully screened 26% of them, consented and enrolled 22% of these, and randomly assigned 48% of consented participants. Primary and secondary outcome analyses will be assessed among randomized men. Conclusions: This study highlights the effort required to reach and engage Black and Latino men for virtually delivered diabetes prevention programs. Forthcoming trial results for weight loss and engagement will further inform efforts to address disparities in diabetes prevention through tailored programming for Black and Latino men. Trial Registration: ClinicalTrials.gov NCT04104243; https://clinicaltrials.gov/study/NCT04104243

Background: Suicide in local jails occurs at a higher rate than in the general population, requiring improvements to risk screening methods. Current suicide risk screening practices in jails are insufficient: They are commonly not conducted using validated screening instruments, not collected by clinically trained professionals, and unlikely to capture honest responses due to the chaotic nature of booking areas. Therefore, new technologies could improve such practices. Several studies have indicated that machine learning (ML) models considerably improve accuracy and have positive predictive value in detecting suicide risk compared with practice as usual (PAU). This study will use administrative data and ML modeling to improve suicide risk detection at jail booking. Objective: This study is primarily focused on gathering preliminary information about the feasibility and practicality of using administrative data and ML modeling for suicide risk detection but also incorporates elements of hypothesis testing pertaining to clinical outcomes. Methods: The study uniquely contributes to our understanding of suicide risk by further validating an existing ML model developed and previously validated by the Mental Health Research Network using Medicaid outpatient health care claims data. This validation uses complete claims data on a sample of approximately 6000 individuals booked into 2 diverse jails in a midwestern state. This model validation uses 313 unique demographic and clinical characteristics from 5 years of historical health care data. It detects suicide risk in jails and postrelease by using merged jail, Medicaid, and vital records data. The study will use jail administrative data for September 1, 2021, through February 28, 2022; Medicaid records data for September 1, 2016, through March 31, 2023; and vital records data for March 1, 2022, through March 31, 2023. Results: First, the algorithm will be validated on the data gathered for the jail sample using the C-statistic and area under the receiver operating characteristic curve. Second, the resulting model will be compared with the jails’ suicide identification PAU to assess risk and detection of identified suicide attempts and deaths from intake through 120 days and 13 months after jail release. The funding timeline for this project is August 1, 2022, through July 31, 2025. The algorithm’s predictions and actual event incidence will be linked and validated in the spring of 2025, with results ready for publication in the fall of 2025. Conclusions: The study will also investigate implementation factors, such as feasibility, acceptability, and appropriateness, to optimize jail uptake. Interview data on the implementation factors will be gathered in the summer of 2025, with expected dissemination in 2026. We hypothesize that a combination of intake screening PAU and the ML model will be the optimal approach, in that the combination will be more accurate and can have practical application in this context.

Background: Diabetes prevention programs focus on people with prediabetes because they have a greater risk of developing type 2 diabetes mellitus than people with normal blood glucose levels. Weight management can reduce this risk. However, in our largely sedentary society, there is less enthusiasm for regular exercise. Whole-body electromyostimulation (WB-EMS) is a training technology that provides exercise-like effects by inducing muscle contractions using electrical currents. There is evidence that local EMS can improve glucose metabolism. Several studies investigated the effect of WB-EMS on cardiometabolic risk factors including blood glucose control in a population of individuals with metabolic syndrome. However, to the best of our knowledge, there is no randomized controlled trial examining the preliminary efficacy of WB-EMS on hemoglobin A1c (HbA1c) levels in individuals with prediabetes. Objective: The objective of this randomized controlled trial is to pilot procedures for a randomized controlled trial testing WB-EMS training on glycemic changes in sedentary adults with prediabetes. Methods: A total of 60 community-dwelling sedentary adults aged 40-65 years with prediabetes will be randomized to one of 3 arms: WB-EMS + an activity tracker and a lifestyle education program (LEP) focusing on diabetes prevention, an activity tracker and LEP, or LEP only, with 20 individuals in each arm. The WB-EMS training will consist of 1.5×20 minutes per week. The intervention will last 16 weeks. As a pilot study, our main outcomes concern the number of participants who will be recruited, and comply with intervention and follow-up. The primary efficacy outcome of interest includes hemoglobin A1c. The intention-to-treat analysis will be conducted with the objective of providing CI estimation of treatment effects. Results: The recruitment of study participants started in February 2024. At the time of submission of this protocol for publication, the recruitment was still ongoing. As of October 2024, a total of 42 participants were allocated to the study groups. The anticipated date of recruitment completion is July 2025. Conclusions: The results of this trial will provide valuable evidence for future investigations comparing the efficacy of the WB-EMS intervention with traditional exercise training to improve glycemic control in this population. Trial Registration: ClinicalTrials.gov NCT06188481; https://clinicaltrials.gov/study/NCT06188481

Background: Even before the COVID-19 pandemic, caregivers of children with rare neurogenetic conditions (NGCs) experienced physical and mental health challenges. These challenges escalated during the COVID-19 pandemic due to crisis-level breakdowns in support services. Tele–mental health and parenting support services expanded rapidly in response to the COVID-19 pandemic and may be well suited to facilitate necessary support interventions for NGC caregivers. However, it remains unclear how to match these evidence-based interventions to individual NGC caregivers’ needs. Objective: Project WellCAST (Supporting Well-Being of Caregivers via Telehealth) is an early-phase clinical trial designed to prospectively test which evidence-based telehealth interventions best meet the needs of NGC caregivers. Methods: Interested and eligible NGC caregivers are enrolled in a 24-week program with 5 phases, including baseline (2 weeks), support program (12 weeks), and follow-up (2 weeks) periods; a 4-week gap separates the phases. Caregivers participate in 2 randomizations, namely support program assignment via a precision health algorithm versus quasi-random assignment and motivational coaching by another NGC caregiver and project staff member (“peer coaching”) versus standard check-ins by a staff member who is not an NGC caregiver (“staff coaching”). Virtual support programs include acceptance and commitment therapy, dialectical and behavioral therapy, culturally informed cognitive behavioral therapy, research units in behavioral intervention, naturalistic communication intervention, Durand sleep intervention, and self-guided resources. A subset of caregivers will participate as waitlist controls before engaging in support programs. We developed and optimized a personalized health decision tree algorithm that matches caregivers to telehealth support programs. We then proceeded to test the feasibility and efficacy of algorithm-assigned support programs across 4 waves of data collection, relative to quasi-random assignment and waitlist controls. During each wave, the personalized health algorithm relies on 2 weeks of baseline data collection using clinical tools and innovative smartphone-based ecological momentary assessments. Across waves, we also test the efficacy of a motivational peer-to-peer coaching protocol, deployed by trained NGC caregiver staff, in enhancing support program uptake and clinical outcomes. Results: Four waves of data collection are scheduled for August 2023 to September 2025. Preregistered analyses will contrast feasibility, efficacy, and acceptability across algorithms and coaching assignments. Multiple waves of data collection will allow us to continually optimize the algorithm and test incremental improvements across project phases. Secondary analyses will probe the feasibility and efficacy of individual evidence-based support programs and peer coaching. Conclusions: Project WellCAST will test whether a digital personalized health decision tree algorithm and peer coaching protocol can prospectively enhance telehealth support program outcomes among NGC caregivers. This project is relevant to the specific population of NGC caregivers and may also inform how brief digital assessments, precision health tools, and community-academic partnerships can enhance the public health response to mental health crises across other high-need populations. Trial Registration: ClinicalTrials.gov NCT05999448; https://clinicaltrials.gov/study/NCT05999448 and OSF Registries 10.17605/OSF.IO/8WNDP; https://osf.io/8wndp

Background: Cancer during pregnancy is a rare and significant life-changing event affecting approximately 1 in 1000-2000 pregnancies. With increasing maternal age and broader application of prenatal screening programs such as the Dutch Non-Invasive Prenatal Testing, incidental detection of maternal cancer is becoming more frequent. Advancements in safe treatment options during pregnancy, supported by the International Network on Cancer Infertility and Pregnancy (INCIP), have led to fewer pregnancy terminations. Consequently, more children are exposed to chemotherapy and other cancer treatments in utero. While short-term safety has been demonstrated for many oncological agents, long-term side effects including physical, neuromotor, neurocognitive, and psychosocial impacts on offspring and their families after delivery are still being assessed. Standard settings for surveillance and care of offspring and their families have, however, never been described. Objective: Given the importance of expertise in assessing the long-term outcomes of children, the Netherlands established the national centralized Cancer in Pregnancy (CIP) offspring outpatient clinic in 2018, which functions as a standard-of-care surveillance clinic and contributes data to the INCIP registry. Here we provide a demographic overview of referred families and to share (logistic) experiences with the national, centralized, multidisciplinary, and standardized long-term surveillance program for all Dutch children with in utero exposure to maternal cancer and its treatment. Methods: The CIP offspring outpatient clinic is located at the Princess Máxima Center for Pediatric Oncology and provides surveillance from infancy until 18 years of age. The, relatively small dedicated team, comprising pediatric oncologists, physiotherapists, and a psychological expert, offers a 1-day, multidisciplinary assessment, including physical examinations, neuromotor tests, cardiac monitoring (for anthracycline exposure), renal and auditory screening (for platinum agents), neurocognitive testing, and psychosocial evaluation. Surveillance is aligned with international INCIP guidelines. Results: From May 2018 to 2024, a total of 226 children (from 221 mothers) have been referred to the CIP offspring outpatient clinic, with 465 follow-up visits completed. The most common maternal cancer types were breast, gynecological, and hematological malignancies. Most women (58%) received chemotherapy during pregnancy; 11% of them had surgery only, 3% underwent radiotherapy, 3% underwent immunotherapy, 16% received a combination of treatment modalities, and 8% did not undergo treatment during pregnancy. Anthracyclines were the most commonly used agents. Median gestational age at delivery was 37.3 weeks. Fourteen percent of the mothers died shortly after delivery, underscoring the emotional and logistical challenges for families. Conclusions: The CIP offspring outpatient clinic provides a unique, structured approach to long-term surveillance for in utero–exposed children, which enables early detection of potential late effects and provides comprehensive family support. By sharing knowledge and experiences from the unique setting of this national centralized CIP offspring outpatient clinic, this initiative may inspire other countries in developing similar translational facilities to support affected families and improve care worldwide.

Background: Assessing the competencies of health profession educators presents significant challenges, leading to the suggestion of implementing Entrustable Professional Activities (EPAs) as a potential solution. EPAs refer to the authority granted to individuals to perform tasks with a specified level of trust and competence. The concept of EPAs emerged from the complexities of competency-based medical education. This scoping review highlights the emerging yet underdeveloped field of EPAs for dental educators. Despite their established utility in medical education, the concept remains relatively novel for dental educators, with limited literature and inconsistent application across studies. Objective: This paper presents a scoping review protocol aimed at systematically elucidating the extent, range, and nature of the literature on EPAs for dental educators, as evaluated in the included resources. This review seeks to answer the following research question: what are the key functional elements of EPAs for dental educators as described in the existing literature? Methods: This scoping review will be conducted in accordance with the framework outlined by Arksey and O’Malley, enhanced by the Joanna Briggs Institute (JBI) guidelines. The literature search will use a 3-step strategy across 5 electronic databases (PubMed, Google Scholar, Scopus, Cochrane Library, and ProQuest), along with additional screening of gray literature. Primary data from relevant studies published from the introduction of EPAs in 2005 through 2024 will be analyzed. This review will include peer-reviewed literature focused on EPAs, specifically those involving dental educators in undergraduate, postgraduate, or continuing education contexts. Studies of any design (qualitative, quantitative, or mixed methods), as well as conceptual papers and reviews, will be considered. Only English-language studies will be included. The literature search process will involve a librarian, while study selection and evidence charting will be conducted by 4 independent reviewers. These reviewers will independently screen titles, abstracts, and full texts against the inclusion criteria. Data will be charted using a standardized extraction form and analyzed thematically. Results: Findings will be presented in both tabular and narrative formats, highlighting the range, characteristics, and key components of EPAs relevant to dental educators. In addition, these findings will be mapped to the competencies of dental educators. This review is estimated to be completed within 6 months and aims to identify gaps for future research, ultimately supporting the advancement of competency-based dental education. The results of this review will serve as a foundation for a larger study focused on developing a framework of EPAs specifically tailored for dental educators. Conclusions: The identification of EPAs and their themes provides an initial framework that can guide the development of more structured, competency-based academic roles for dental educators. A tailored EPA framework holds promise not only for clarifying faculty expectations and enhancing performance assessment but also for supporting faculty development. Trial Registration:

Background: The acute effect of hemodialysis (HD) on left ventricular mechanics has been evaluated in several studies; however, their results are not consistent. Eventually, the heart and the arterial system behave as an interconnected system and not as isolated structures; thus, the evaluation of the interaction of cardiac contractility with the arterial system would provide a more comprehensive understanding of cardiovascular function and cardiac energetics. However, there have not been any studies demonstrating changes in terms of volumes, contractility, intraventricular pressure gradient distribution, and vascular properties in response to changes in loading conditions and their impact on the outcome in patients undergoing HD. Recently, a noninvasive method for assessing left ventricular pressure-volume loop and ventriculo-arterial coupling (VAC) from feature-tracking cardiac magnetic resonance or echocardiography has been proposed. We believe that this method allows a comprehensive evaluation of the hemodynamic status of the patients undergoing HD, including the relationships between cardiac function and arterial elastance, and might provide prognostic information. Objective: The primary objective of this study is to evaluate changes in VAC before and after a HD session. The secondary objective is to assess the prognostic value of VAC parameters in predicting adverse outcomes. Methods: A 2D transthoracic echocardiogram will be performed before and after a HD session in patients with end-stage renal disease. We target to enroll 323 patients. Images will be analyzed with advanced software based on speckle-tracking, able to reconstruct the pressure-volume loop. From the pressure-volume loop, arterial (Ea) and ventricular (Ees) elastance will be derived. VAC will be calculated as the Ea/Ees ratio. Patients will be followed up for 18 months. Primary endpoints will be a composite of all causes of death, nonfatal myocardial infarction, and hospitalization due to worsening heart failure. Results: The study received funding in August 2024, with patients’ enrollment scheduled to take place from January 1 to June 30, 2025. Data analysis will start in April 2025 and is expected to continue until June 2026. The findings of the study are tentatively planned for publication in the winter of 2027. Conclusions: This study will provide data on the changes in VAC induced by HD and their potential prognostic value. This assessment could be useful for tailoring volume depletion during HD and to improve patients’ outcomes. Trial Registration: ClinicalTrials.gov NCT06622928; https://clinicaltrials.gov/study/NCT06622928

Background: Valganciclovir (VGCV) is the first-line drug for preemptive therapy of cytomegalovirus (CMV) infections. However, even when administered at the dose specified in the package insert, there is significant interindividual variability in the plasma concentrations of ganciclovir (GCV). In addition, correlations have been reported between the area under the concentration–time curve and therapeutic efficacy or adverse events. Therefore, therapeutic drug monitoring (TDM) can be used to improve the efficacy and safety of preemptive VGCV therapy. Objective: This study aims to evaluate whether the dosage adjustment of VGCV based on TDM in patients undergoing preemptive therapy for CMV infections is associated with the successful completion rate of treatment without severe hematological adverse effects. Methods: This phase II, single-center, single-arm trial aims to enroll 40 patients admitted at the Department of Rheumatology and Clinical Immunology, Kobe University Hospital, who will receive oral VGCV as preemptive therapy for CMV infections. Participants will begin treatment with VGCV at the dose recommended in the package insert, with subsequent dose adjustments based on weekly TDM results. The primary end point will be the proportion of patients who achieve CMV antigenemia negativity within 3 weeks without severe hematological adverse events. The secondary end points will include weekly changes in CMV antigen levels, total VGCV dose, and duration of preemptive therapy. For safety evaluation, the occurrence, type, and severity of VGCV-related adverse events will be analyzed. Additionally, this study will explore the correlations between the efficacy and safety of preemptive therapy and the pharmacokinetic parameters of GCV, CMV-polymerase chain reaction values, and nudix hydrolase 15 (NUDT15) genetic polymorphisms. The correlation between GCV plasma concentrations obtained from regular venous blood and blood concentrations will be examined using dried blood spots. Results: This study began with patient recruitment in September 2024, with 5 participants enrolled as of June 16, 2025. The target enrollment is 40 participants, and the anticipated study completion is set for July 2027. Conclusions: This is the first study to investigate the impact of TDM intervention in patients receiving VGCV as preemptive therapy. The findings are postulated to provide valuable evidence regarding the utility of TDM in patients receiving VGCV as preemptive therapy. Trial Registration: Japan Registry of Clinical Trials jRCTs051240080; https://jrct.mhlw.go.jp/latest-detail/jRCTs051240080

Background: Metabolic syndrome (MetS) is a growing concern among adult populations in India, particularly among those living in urban, low-income settings. This group is challenged by a combination of risk factors, including an urbanized lifestyle, poor access to health care, and financial limitations, leading to high levels of obesity, diabetes, and hypertension. Objective: This study aims to address this challenge by designing, developing, and piloting a tailored, mobile-enabled, interactive, digital health intervention to enhance self-management of MetS among individuals living in urban, low-income settings in New Delhi, India. Methods: The study uses mixed methods, including both quantitative and qualitative data collection, to design and evaluate the effectiveness of the intervention built on a multifactorial model in improving the self-management of MetS. Data will be collected at baseline and 12 months from adults living in urban, low-income settings in New Delhi. The results will contribute to our understanding of the interplay of risk factors in MetS and the impact of tailored digital health interventions in addressing this challenge. The findings will be disseminated to both national and international audiences through peer-reviewed publications. Results: This study was funded in March 2022 for 3 years. The project started in April 2022. Data collection began in June 2022. The results are expected to be published in 2025. Conclusions: The study is expected to provide valuable insights into the role of digital health interventions in enhancing the self-management of MetS among urban, low-income populations.