JMIR Research Protocols

Background: Maternal mental health problems are common after prenatal diagnosis of congenital heart disease (CHD), with long-term implications for child and family wellbeing. HEARTPrep is a prenatal psychosocial intervention with three self-paced modules and corresponding telehealth sessions, delivered during pregnancy via mobile app to improve mental health and wellbeing for mothers expecting a baby with CHD. This proof-of-concept study evaluated the feasibility of HEARTPrep and examined maternal mental health and psychosocial functioning throughout participation. Methods: Participants were mothers receiving care for a fetal CHD diagnosis within one health system. Feasibility was assessed via rates of enrollment and completion. Mothers completed 4-item PROMIS questionnaires assessing anxiety, depression, and social isolation and reported self-efficacy and hope on a weekly basis throughout HEARTPrep. Results: Of 34 recruited mothers, 29 (85%) enrolled and two were subsequently not eligible (delivery prior to participation, change in fetal diagnosis), resulting in a final sample of 27 mothers. The majority (n = 22, 81%) completed all three telehealth sessions and Modules 1 (n = 22, 81%) and 2 (n = 19, 70%), with just over half (n = 14, 52%) completing Module 3 prior to delivery. Mean PROMIS depression T-scores decreased from 57.5 to 52.9, and 48% of mothers had a decrease in depression scores exceeding the meaningful change threshold (half standard deviation). The percentage of mothers reporting high self-efficacy increased from 19% to 48%. Conclusions: HEARTPrep is feasible and corresponds with reduced maternal depression and increased self-efficacy, supporting proof-of-concept. A randomized controlled trial is needed to determine whether HEARTPrep improves outcomes compared to a control group.

Background: Two-thirds of Dutch cardiovascular risk management (CVRM) for patients at risk of cardiovascular disease is delivered in primary care practices. While individual risk scores are increasingly used during consultation, a population-level structure for risk-based patient outreach is not currently available. We therefore developed the PROSPERA programme, a multilevel intervention comprising population-level risk stratification and individual-level support tools. Aim: To assess anticipated and experienced barriers and facilitators among healthcare professionals (HCPs) to inform implementation in primary care. Methods: We conducted four focus groups and six interviews with nine primary care HCPs to explore anticipated and experienced barriers and facilitators. Inductive codes were thematically analysed and assigned to corresponding domains of the Theoretical Domains Framework (TDF) and the related Capability, Opportunity, Motivation model of Behaviour. Results: Barriers and facilitators were identified in 11 TDF domains. Population-level barriers included altered professional roles and limitations in technological infrastructure. Individual-level barriers were limited skills in interpreting risk calculations and difficulty integrating tools into clinical routine. Facilitators were related to beliefs on the importance of providing proactive care (population level), the use of U-Prevent for risk communication (individual level) and positive patient responses to the Lifestylecheck questionnaire (individual level). Conclusion: Addressing barriers and facilitators identified at both the population and individual levels can support implementation of the PROSPERA programme. Opportunities exist in education and training of HCPs in risk communication, as well as support in restructuring the physical and digital environment.

Background: Medical and doctoral students in health sciences represent a strategic public health lever as future professionals who will have a lasting influence on healthcare practices and the overall quality of health systems. Impaired quality of life and mental health issues among these students, coupled with scarce prevention programmes, led us to develop PROMESS-Group, an innovative multimodal programme designed to promote healthier lifestyle habits among university students. Methods: We will conduct a 2-arm randomised, controlled, superiority monocentric trial to assess the effect of this programme on medical and doctoral students compared to a control group. The intervention will consist of six sessions covering stress, sleep and physical activity domains. Each session will include group and individual meetings led by trained peer experts, focusing on needs assessment, self-care education, and personalised goals setting. Students' quality of life, academic self-efficacy, and broader health outcomes will be assessed using validated questionnaires and objective tools at baseline, during, and post-intervention. Data will be analysed according to the intention-to-treat principle and presented in accordance with CONSORT guidelines. Ethical approval was obtained from the institutional review board (IRB2025021802). All procedures will be performed in adherence to the Helsinki Declaration. Discussion: This study will enable the generation of high-quality evidence to evaluate the programme's effects on students' quality of life and related psychosocial outcomes, and may inform evidence-based health promotion strategies in university settings. Trial registration: ClinicalTrials.gov: NCT07030751 (https://clinicaltrials.gov/study/NCT07030751?locStr=Lyon,%20France&country=FR&state=Auvergne-Rh%C3%B4ne-Alpes&city=Lyon&cond=promess%20group&rank=1), 06.12.2025 - retrospectively registered. This protocol study follows the SPIRIT guidelines (Appendix 1). Keywords: Doctoral student, health behaviour, medical student, quality of life, physical activity, sleep, stress

Background Depression and anxiety are prevalent among cardiovascular disease (CVD) patients and significantly worsen clinical outcomes, increasing complications, recurrent events, and healthcare costs. Evidence shows that psychological stress, depression, and anxiety elevate CVD risk, while post-discharge nurse-led telephone follow-up has demonstrated benefits in patient support and symptom management. Little is known about its impact on mental health. Objective The aim of this study was to evaluate the effects of implementing the "nurse telephone follow-up" project on depression, anxiety and stress levels among cardiovascular patients. Methods An experimental study was conducted with 60 randomly selected patients from the Coronary Care Unit (CCU) department of a hospital in Iran, who were divided into two groups: an intervention group and a control group. The educational intervention was administered within two weeks after discharge. Data were collected via the Depression Anxiety Stress Scale (DASS-21). Descriptive analysis, Mann?Whitney and Wilcoxon tests, Generalized Estimating Equations (GEE) regression, and Spearmans correlation were used for data analysis. Results The mean age of the patients was 57.43 {+/-} 15.33 years. While no significant difference was found between the intervention and control groups in terms of depression, anxiety, or stress (p>0.05), the depression score decreased by 1.53 points, and the anxiety score decreased by 1.18 points after the intervention. Furthermore, an increase in patients ejection fraction (EF) score was associated with a 0.1 decrease in both depression and anxiety levels. No significant relationship was found between stress and any variables. Conclusions The results of this study suggest that psychological and therapeutic interventions may help reduce depression and anxiety in patients with cardiovascular diseases. However, this requires further detailed evaluation and additional studies. The potential link between improved cardiac function and reduced psychological symptoms could be effective in designing more comprehensive treatments for these patients.

Introduction: Menstrual cycle phase has been proposed as a source of intra-individual variability in resting energy expenditure and the thermic effect of food in premenopausal females, yet studies examining the thermic effect of food across menstrual cycle phases report conflicting findings. Methods: This protocol describes a secondary analysis of prespecified outcomes from a non-randomized, two-period crossover trial primarily designed to assess postprandial plasma triglyceride concentrations across menstrual cycle phases (ClinicalTrials.gov: NCT07459465) in 12 premenopausal females aged 18-30 years, free of chronic disease and hormonal contraceptive use, recruited in Ottawa, Canada. Participants complete two experimental sessions: one in the early follicular phase and one in the mid-luteal phase, each involving consumption of a high-fat meal. Eleven secondary outcomes will be reported: fasting resting energy expenditure, thermic effect of food, respiratory exchange ratio, carbohydrate oxidation rate, lipid oxidation rate, desire to eat, hunger, fullness, prospective food consumption, serum beta-estradiol, and serum progesterone. Masked outcome analyses are performed using linear mixed-effects models. Results: Recruitment began on 26 March 2026; results will be reported in the Stage 2 manuscript. Discussion: Findings from this trial may help clarify whether menstrual cycle phase constitutes a meaningful source of intra-individual variability in energy metabolism, with implications for the design of metabolic research in premenopausal females.

Background: Pre-exposure prophylaxis (PrEP) has demonstrated a significant reduction in HIV infections among men who have sex with men (MSM), however, low medication adherence hinders its preventative effectiveness. Traditional approaches, such as health education and face-to-face inquiry (HEF), have demonstrated certain efficacy in improving PrEP adherence. However, these methods are resource-intensive and often plagued by delays, rendering timely and precise interventions challenging. This randomized controlled trial aims to assess the effectiveness of an intervention comprising AI-chatbot for PrEP (PrEP-bot) and Smart pillbox (SPB) (PrEP-bot-SPB) strategy to improve PrEP adherence among MSM compared to HEF.Methods and analysis: A three-arm, multicenter, open-lable RCT will be conducted with Chinese MSM [≥]18 years. A total of 300 participants will be recruited through three sources, including hospitals, community-based organizations (CBOs) and peer referral in five cities: Shenzhen, Beijing, Qingdao, Hangzhou and Zhengzhou. After completing baseline survey, participants will be randomized evenly into interventions or control groups: the PrEP-bot group, the PrEP-bot-SPB group, and the HEF control group. Participants in the PrEP-bot group will be granted access to an AI-chatbot agent through WeChat. This agent will: 1) generate personalized PrEP medication plans; 2) provide medication reminders and PrEP-related health check-ups notifications; 3) inquire about missed doses to deliver tailored interventions; 4) answer participant questions about PrEP using guideline-based knowledge. Participants in the PrEP-bot-SPB group will receive both the SPB and the PrEP-bot interventions. SPB could delivers medication reminders. Participants in HEF group will receive a health education pamphlet introducing PrEP and knowledge related to PrEP medication adherence at baseline and face-to-face inquiry every three months. Outcomes will be assessed for both short-term and medium-to-long-term effects. The primary objective is the effectiveness in improving PrEP adherence measured by self-report, Eight-Item Morisky medication adherence scale (MMAS-8) and concentration of Tenofovir in dried blood spots (DBS) (PrEP adherence [≥]90%) at 3 months follow-up. Secondary outcomes include: 1) effectiveness in preventing HIV infection measured by HIV-self test (HIVST); 2) effectiveness of PrEP-related health check-ups; 3) the effectiveness, feasibility, acceptability, and user satisfaction with the PrEP-bot; 4) effectiveness in improving PrEP adherence at 6-month, 9-month and 12-month follow-up periods. All participants will receive quarterly follow-up visits during the 12-month study period. Intention-to-treat analysis and per protocol set (PPS) analysis will be used.Results: Recruitment and enrollment of participants began in January 2026 and is currently ongoing.Discussion: This study is expected to establish a novel AI-based intervention model for PrEP, providing innovative strategies for HIV control among MSM populations. If the PrEP-bot is proven non-inferior to HEF, it could offer users real-time, precise, and personalized interventions while simultaneously addressing PrEP-related inquiries and health check-ups reminders. Importantly, this approach would achieve significant reductions in resource requirements for implementation and maintenance and be more cost-effective. With the ongoing advancement of AI technologies, PrEP-bot holds substantial promise for widespread implementation in PrEP adherence, potentially revolutionizing HIV prevention for MSM in China through this innovative intervention modality.Trial registration: ChiCTR2500111280 (Chinese Clinical Trial Registry). Date of registration: 29 October 2025.

Background: Obesity is globally recognized as a complex, multifactorial chronic disease, with biological, psychological, environmental and behavioural factors involved in both disease pathogenesis and maintenance. Although previous group-based studies demonstrated involvement of each of these factors, there is large inter-individual variability in the factors contributing to disease development as well as intervention outcomes, causing limited translatability to the individual level. This heterogeneity in treatment effectiveness might be due to differential causal and maintenance factors of obesity. To enable the transition from a one-size-fits-all approach to a more personalized approach for individuals with overweight or obesity, this study aims to investigate if and how the degree of weight loss and changes in daily life behaviour after a combined lifestyle intervention depend on individual baseline profiles comprising of person characteristics, biological, psychological, environmental and behavioural factors. Methods: This study will include 600 individuals varying in BMI, 200 participants with a healthy BMI (18.5-24.9kg/m2), 200 with overweight (BMI 25.0-29.9kg/m2), and 200 with obesity (BMI [≥]30.0kg/m2). For all participants, a comprehensive individual baseline profile is created, including person characteristics, biological, psychological, environmental and behavioural factors. A clustering method is applied to identify clusters of participants with similar characteristics. Next, we examine if and how these clusters are linked to bodyweight indicators measured at baseline, and how they relate to daily lifestyle behaviour, as measured by ecological momentary assessment (EMA) using a smartphone app and sensor technology (3-week measurements). Individuals with overweight or obesity will be randomized to the intensive lifestyle intervention or a lifestyle information condition, to determine if treatment response can be predicted based on cluster characteristics, how daily lifestyle behaviour changes after an intervention, and how changes in daily lifestyle behaviour relate to treatment response. Discussion: The End of Average study aims to characterize a large set of individuals varying in body weight to predict intervention effectiveness measured as changes in body weight indicators and in daily lifestyle behaviours. If reliable predictors of treatment success can be identified, these can be applied in personalized lifestyle interventions to improve lifestyle behaviour, body weight management and overall health.

INTRODUCTION In the multiple-risk approach of cardiovascular disease management, communication of cardiovascular disease risk and its prevention play a significant role. in Sri Lanka, this function is conducted via Healthy Lifestyle Centres. METHODOLOGY A clinical audit was conducted to describe communication quality in 79 healthy lifestyle centers. A checklist developed based on Patient-Centered Communication Tools with the support of an expert panel. Two trained observers independently conducted the observations while the healthcare provider at the Healthy Lifestyle Centre revealed details of cardiovascular disease risk communication and health education sessions. RESULTS: The majority of Healthy Lifestyle Centers involved patients in decision-making (n = 228, 92.0%), explained patient choices (n = 230, 92.8%) and responded to patients' interest in decision-making (n =2 35, 99.2%). Most patients received a summary (n =159,67.1%), a follow-up plan (n =212,89.5%) and were communicated in a jargon-free language (n =127,53.6%). The majority of sessions demonstrated satisfactory use of examples (95.7%, n = 22), and responsiveness to questions (73.9%, n =17). However, most sessions were unsatisfactory regarding provision of a follow-up plan (95.7%, n = 22), encouragement of questions (95.7%, n = 22), allowing clients to talk (87.0%, n = 20), and active listening (69.6%, n = 16). CONCLUSIONS: Strengthening healthcare worker training in patient-centred communication especially shared decision-making, active listening, and encouraging patient questions are essential to improve cardiovascular disease risk communication and patient adherence to preventive guidelines at Healthy Lifestyle Centres. Key words Communication, Cardiovascular disease risk, health communication, effective communication, paternalistic healthcare

Background: Black and Latino adults in the United States experience a disproportionate burden of cardiometabolic conditions due to interacting behavioral, social, and structural drivers of health. Less is known about the impact of integrating digital health tools into CHW-led interventions to improve cardiometabolic health. This trial evaluates a multilevel community-digital health promotion model delivered by CHWs to improve service utilization, health behaviors and cardiometabolic health among Black and Latino adults. Methods: This community-partnered trial uses a randomized delayed-control group with a phased recruitment design. Four cohorts (N = 664) are enrolled through three community-based organizations (CBOs). Eligible participants are 18 years who self-identify as Black or Latino, and have prediabetes/diabetes, hypertension, or overweight/obesity. Participants are allocated to either (1) a multilevel intervention consisting of CBO and CHW capacity building combined with individualized CHW-led lifestyle coaching and group activities supported by digital tools, or (2) a delayed control group receiving SMS-only cardiometabolic health education. Data collected at baseline, 6, 9, and 18 months include surveys and health metrics. Qualitative data are collected from participants and community partners to assess intervention acceptability, implementation facilitators and barriers, and sustainability. Results: The primary outcome is health service utilization at 6 and 9 months. Secondary outcomes include health behaviors, health metrics, and social determinants of health. Sustainability of health behaviors and health metrics is assessed at 18 months. Conclusions: Findings will provide evidence to inform scalable, sustainable community-digital health models for CHW-supported cardiometabolic health interventions in underserved communities.

Introduction: Physical activity during pregnancy can be tracked directly by accelerometer measurements and indirectly by validated questionnaires. Considering the advancement of the Internet of Things (IOT), managing and/or monitoring physical activities can be better explored to analyze individuals, as well as indirectly compare the intensity and domains of physical activities carried out by pregnant women. The project, called 'EVA'(Expert Virtual Assistant), suggests combining several fields of knowledge to obtain better information about physical activity during pregnancy, surpassing the claim made in previous research that studying and measuring the duration of daily physical activities in pregnant women is a challenge. Objective: In the present study, we present the results of the first stage of the EVA project, which aims to develop a Virtual Assistant (VA) in Portuguese, providing examples of health management features for monitoring Physical Activity measurements for pregnant women assisted in the Unified Health System (SUS) and the adaptation of the Pregnancy Physical Activity Questionnaire (PPAQ). Methods and Analysis: The methods used were developed in two stages: adapting the physical activity questionnaire and building the Virtual Assistent to monitor physical activities. Thirty pregnant women who used the Unified Health System (SUS) in the city of Ribeir&atildeo Preto, Brazil participated in the study. The pregnant women wore sensor wristbands (accelerometers) and answered the sociodemographic, lifestyle and physical activity questionnaires via an application developed for this study. Results: The questionnaire used was the PPAQ adapted for Brazilian pregnant women. The most important changes were in the occupational domain for the house cleaning and in sedentary behavior activities. In the pilot study, it was observed that pregnant women spend more energy at home and in light and moderate intensity activities. textbfConclusion:This study made important contributions to evaluating PA in pregnant women. The proposal and studies for the construction of the AV-EVA, the inclusion of a specific occupational domain for pregnant women with domestic occupations and the new cutoff points for PA intensity measurements obtained via accelerometers.

Introduction: Hypertension is the world's leading cause of death, and depression its leading cause of disability. Control rates for these noncommunicable diseases (NCDs) are low in low and middle-income countries (LMICs). Many LMICs have programs to screen and treat underserved communities for infectious diseases, but evidence to adapt them to treat NCDs is limited. We developed and tested a non-communicable disease program through Ghana's Community-Based Health Planning and Services (CHPS) primary care initiative. Methods: We trained 8 CHPS nurses to diagnose and treat hypertension and depression through door-to-door screening and pharmacotherapy. Physician assistants provided telehealth supervision. We combined this treatment with volunteer counseling to boost medication adherence, improve mood, and change health behaviors. We called the 90-day intervention the CHPS Opportunity for Mentally and Behaviorally Integrated NCD Engagement (COMBINE). Results: We recruited 60 adults from 580 screened: 37 with hypertension (mean blood pressure (BP) of 149/91 mm Hg) and 23 with depression (mean physician health questionnaire (PHQ-9) score of 13.3). After 90 days, 57/60 (95%) completed the intervention: 32/37 (86%) achieved blood pressure control (mean BP 122/75 mm Hg), and 19 of 20 (95%) achieved depression control (mean PHQ-9 score 2.0). After 12 months, 51/60 were retained: 33/37 with hypertension (89%) and 18/23 with depression (78%), with a mean BP of 121/75 and PHQ-9 score of 1.4 respectively. All 51 (100%) achieved disease control at 12 months. 5 persons left by migration and 4 by escalation to higher-level care. Conclusions: The COMBINE model achieved high levels of diagnosis, care retention, and disease control, with minimal adverse events, in a remote setting with limited usual NCD care. This model suggests a novel means to improve the care cascade for these and other noncommunicable diseases through existing non-physician care models in LMICs, warranting further controlled testing at scale.

Objective: Hispanic/Latinx populations in the U.S. experience higher rates of chronic disease linked to physical inactivity, yet digital health interventions remain largely inaccessible to more than 16 million Hispanic/Latinx adults with limited English proficiency. While large language models (LLMs) offer scalable personalization, their use in non-English behavioral coaching is unexplored. This study introduces MHC-Coach-ES, a Spanish-language LLM fine-tuned on the Transtheoretical Model (TTM) of behavior change. Materials and Methods: We fine-tuned Llama 3-70B-Instruct using a two-stage pipeline. First, the model was adapted to Spanish health and motivational language using a 2.21-million-token corpus. Second, it was instruction-tuned on 3,268 translated human written messages to align the model with the Transtheoretical Model (TTM) of Behavioral Change. We compared MHC-Coach-ES with Llama 3-70B-Instruct and translated human-expert messages using a forced-choice preference survey (N = 77) and blinded expert review (N = 2). Results: Spanish-speaking participants significantly preferred MHC-Coach-ES messages over translated human-expert messages (81% preference, P<0.001). Linguistic analysis showed that MHC-Coach-ES produced more temporally anchored messages than the base model (65% vs. 20%), while maintaining readability. In blinded evaluation, clinical experts rated MHC-Coach-ES higher for alignment with Transtheoretical Model stages than human-expert messages (4.83 vs. 4.38 out of 5). The base model also outperformed translated expert messages across preference and expert ratings. Conclusions: Generative AI can operationalize behavioral science frameworks in Spanish, offering a scalable approach to reducing health disparities. The strong performance of both MHC-Coach-ES and the base model highlights the promise of generative and personalized approaches over translation-based localization for theory-driven behavioral interventions.

Introduction Creativity is important in surgery for problem-solving in the operating room and the development of surgical innovations that improve patient outcomes. However, our limited understanding of what the characteristics and competencies of the highly creative surgeon are has inhibited our ability to develop the tools, programs and interventions necessary for cultivating the creativity of surgeons. We present the protocol for the INSPIRE Study, which aims to identify the factors associated with high creative achievement in surgeons. Methods and Analysis We have designed a sequential mixed-method study, including a cohort study accompanied by qualitative semi-structured interviews. The primary objective of this study will be to identify factors associated with high creative achievement in surgeons, to be assessed through direct involvement in innovation or invention, or a top score (10 out of 10) on any domain in the Inventory of Creative Activities and Achievements questionnaire. We plan to measure 39 different personal, domain-specific, domain-general, and environmental/motivational variables, chosen based on previous literature and on exploratory grounds, to be assessed as possible factors of creative potential. Multivariable logistic regression is planned, with high creative achievement as the dependent variable and all 39 potential factors of creative potential as independent variables. Ethics and Dissemination Ethics approval from the Hamilton Integrated Research Ethics Board has been obtained and no harm is expected due to participation in this study. To facilitate knowledge translation, we plan to publish the feasibility data and results in peer-reviewed journals, and present at international surgical and creativity conferences.

Background: Individuals with mild cognitive impairment (MCI) experience cognitive and functional declines that can negatively impact mood and reduce feelings of self-efficacy. These changes can also lead to elevated distress in care partners (CPs). Therefore, interventions that address quality of life and psychosocial factors in people with MCI and their CPs are needed. Objective: The present study evaluated the impact of a multidomain lifestyle program, the Cognitive Empowerment Program (CEP), on changes in psychosocial functioning, particularly empowerment, in people with MCI and their CPs. Methods: Participants were 94 people with MCI (Mean= 75.1 years old, 45.7% female, 81.9% white) and their CPs (Mean= 69.1 years old, 71.3% female, 87.3% white) that completed the 12-month CEP program comprised of physical, cognitive, and psychosocial interventions. Questionnaires were administered pre- and post-program to assess empowerment, self-efficacy, meaning and purpose, depression, and stress in participants with MCI alongside empowerment, depression, stress, and caregiving burden in CPs. Results: After completing the CEP program, participants with MCI endorsed higher empowerment and self-efficacy as well as fewer symptoms of depression and perceived stress. CPs endorsed feeling more empowered despite elevated caregiver burden. Conclusions: These results suggest multidomain lifestyle programs can positively impact wellbeing in MCI. Future research should focus on refining delivery models, exploring integration with pharmacological treatments, prioritizing inclusion of diverse populations, and measuring long-term outcomes to strengthen the reach and impact of programs like CEP.

Introduction: Youth mental health presentations are largely heterogenous, making it difficult to match individuals to the most appropriate interventions. Personalised, measurement-based care has the potential to improve clinical decision-making and support shared decision-making, but remains challenging to implement in routine practice. Advances in digital monitoring and causal modelling offer new opportunities to identify individual-level processes driving mental health difficulties and to generate personalised decision-support. This pilot study aims to evaluate the feasibility and acceptability of the Minding Your Mind computational decision-support approach, a newly developed approach integrating routine outcome monitoring, individual-level causal modelling, and personalised feedback to support shared decision-making between young people and their clinicians. Methods and analysis: The study involves two phases. Phase 1 will recruit young people aged 15-25 years and mental health clinicians to participate in workshops to co-design the decision-support approach and its implementation into routine practice. Phase 2 is a prospective, single-arm feasibility study involving young people receiving mental health care and their treating clinicians. Primary outcomes include feasibility, acceptability, appropriateness, and usability of the decision-support approach, assessed via self-report and objective process indicators. Secondary outcomes include changes in use and experiences with shared decision-making, and clinical and functional outcomes. Quantitative analyses will be primarily descriptive, with exploratory pre-post comparisons and sensitivity analyses. Qualitative interviews will explore user experiences and implementation barriers and facilitators. Ethics and dissemination: This study has been approved by the Sydney Local Health District (RPAH Zone) Human Research Ethics Committee (X25-0341). All participants will provide informed consent prior to participation. Findings will be disseminated through peer-reviewed publications, conference presentations, and accessible summaries co-developed with young people with lived experience.

Background: This study examined the association between caregiving demands and depression symptoms among caregivers of individuals with Down syndrome during the COVID-19 pandemic. Method: We conducted an online survey of 200 caregivers of children and adults with Down syndrome, including demographic data, the Patient Health Questionnaire-8 (PHQ-8), and questions about lack of childcare and taking over instruction during the pandemic. A multiple linear regression analysis identified predictors of caregiver depression symptoms. Results: Household income (B = -3.45, p < .001) and having to take over instruction (B = 2.24, p < .001) were significant predictors of PHQ-8 scores. Child age, caregiver gender, difficulty paying for health insurance, and lack of childcare were not significant predictors. Conclusions: Lower income and instructional caregiving demands were associated with higher depression symptoms among caregivers of individuals with Down syndrome, suggesting potential targets for policy and intervention during future public health emergencies.

Background: Head and neck cancer (HNC) patients experience clinically significant anxiety and depression in 65-85% of cases during active treatment. Current supportive care lacks personalized, real-time non-pharmacological interventions. Skitii is a novel HRV-adaptive music therapy system that uses continuous RMSSD (root mean square of successive differences) monitoring via a Polar H10 chest sensor to select music in real-time, targeting parasympathetic recovery (RMSSD >=30ms). Methods: This is a prospective, open-label, randomized controlled trial (1:1 allocation) at Yenepoya Medical College Hospital, Mangalore, India. Adults aged 18-75 years with confirmed head and neck cancer (any subsite, Stage I-IV) undergoing radiotherapy and/or chemotherapy with baseline distress (HADS >=8 or NCCN Distress Thermometer >=4) will be enrolled. Participants are randomized to Skitii adaptive music therapy (20-minute sessions, 3 times daily, 3 weeks) or static music therapy control. Skitii uses a two-phase algorithm: Phase 1 (0-2.5 minutes) uses heart rate as a stress proxy for immediate music selection; Phase 2 (2.5-20 minutes) uses RMSSD to adapt music every 2.5 minutes when physiological state changes by >=20%. Primary endpoints are HADS-Anxiety score and resting RMSSD at Week 3. Sample size is 70 (35 per arm), powered at 80% to detect a 2.5-point HADS difference (SD=3.8, alpha=0.05, 15% dropout). Analysis is ANCOVA, intent-to-treat. Discussion: This is the first randomized controlled trial evaluating RMSSD-based adaptive music therapy in cancer patients. The active control design isolates the effect of the adaptive algorithm from music exposure alone. If positive, results will support a scalable, cost-effective supportive care intervention with objective physiological monitoring, and provide the clinical evidence base for CDSCO Class B medical device approval for Skitii in India, with future CE Mark and FDA applications planned. Trial Registration: Clinical Trials Registry - India CTRI CTRI/2025/11/116732

Background: High blood pressure (BP) is an often treatable cause of cardiovascular disease. We developed an intervention, featuring a cardiovascular expert team and a toolbox, to support healthcare professionals (HCPs) in hypertension management and enhance patient self-management. Aim: This study evaluates the adoption and feasibility of this intervention. Design and Setting: A mixed-methods study in general practices in the Netherlands. Methods: HCPs could consult a cardiovascular expert team and use a self-management toolbox for their patients as preferred. We interviewed HCPs guided by the Consolidated Framework of Implementation Research (CFIR), and HCPs completed the Determinants of Implementation Behaviour Questionnaire (DIBQ). Using CFIR-ERIC matching tool, we matched implementation strategies to identified barriers. Adults with elevated BP, who were prescribed at least two blood pressure lowering medications were eligible to participate. Patient and disease characteristics were extracted from the electronical medical record. Results: Of 591 eligible patients at thirteen general practices, 176 participated. The cardiovascular expert team was well-received, with 33 unique consultations, although nurse practitioners (NPs) might need the expertise of the expert team more frequently than general practitioners (GP) (adoption). The toolbox was perceived as challenging to use (feasibility). We subsequently identified three key strategies to improve implementation. Mean systolic and diastolic BP were 158/87 mmHg at baseline and 148/85 mmHg after 12 months, although this change cannot be conclusively linked to the intervention. Conclusions: Structured implementation strategies may be helpful in hypertension management. The cardiovascular expert team was considered valuable, but might be better targeted to NPs rather than GPs.

Background Endoscopic pituitary surgery involves navigating high-stakes anatomy where complications, such as carotid artery injury, cause devastating morbidity. While computer vision AI offers potential for real-time anatomical recognition to mitigate these risks, successful translation requires rigorous human-factors and performance evaluation. We present the iterative development and preclinical evaluation of a surgeon-controlled, real-time AI-assisted navigation system. Methods Guided by IDEAL Stage 0 and DECIDE-AI frameworks, the study was conducted in two phases. Phase 1 was an exploratory study where surgeons used the system during high-fidelity simulated surgery and provided feedback via "Think Aloud" protocols and surveys. Following prototype iteration, a Phase 2 randomized crossover comparative trial was conducted with 19 neurosurgeons (15 trainees, 4 experts) performing high-fidelity simulated tumour resections with and without AI assistance, separated by a minimum 2-week washout. The primary outcome was surgical technical performance (OSATS). Workload, educational value, usability, trust, and implementation outcomes were also assessed. Results Phase 1 informed hardware, model, and interface refinements, including optimized pedal-controlled overlays and prediction confidence metrics. In the comparative trial, AI assistance significantly improved overall technical performance (OSATS 19.79+/-4.06 vs. 17.32+/-4.11; p=0.027). This gain was experience-dependent; AI significantly augmented trainee performance (19.20+/-3.76 vs. 16.60+/-3.78), narrowing the proficiency gap, while expert performance remained high and stable. 100% of participants identified the system as a useful training tool. However, subjective workload was significantly higher in the AI arm (SURG-TLX 26.42+/-9.56 vs. 22.26+/-7.81; p=0.014). Despite this, usability (SUS 75.13+/-14.31) and implementation feasibility, acceptability, and appropriateness scores were consistently high (means >4.4/5). Conclusions This study provides a stepwise process for real-time AI development using pituitary surgery as a high-stakes exemplar. The refined surgeon-centric AI system improves training and technical performance, particularly for trainees. Next steps involve first-in-human studies and further exploration of longer-term human factors such as over-reliance, cognitive overload mitigation and trust calibration.

Background: Medical registries have gained importance in the evaluation of healthcare quality outcomes. In the absence of high-quality evidence, such as randomized controlled trials, studies based on registry data are essential for informing clinical guidelines. Methods for assessing data quality are rarely described in detail. To ensure the credibility of registry-based studies, registries must use all available technical and operational means to guarantee high data quality. Method: Eurocrine(R) is a pan-European endocrine surgical database and quality registry initially funded by the EU healthcare programme, which started in 2015 and now includes more than 200,000 interventions as of April 2025. To ensure high data quality, interactive and standardized reports are created via Microsoft Power BI, which are created both centrally and locally. In addition, comprehensive data quality analyses were performed via the R-based package dataquieR. Results: Although a multitude of technical measures (for example, input screen design and real-time plausibility checks during data entry) are in place, they are not sufficient to prevent human errors at data entry. Errors identified in the reports were corrected, and preventive measures were implemented. Overall, the data quality was assessed as very good in terms of completeness, accuracy, and consistency. Conclusion: It is very important to provide registry users with an efficient and smart tool to identify data issues, as they have the clinical information to correct them. Data quality reports generated with dataquieR represent an effective tool for registry administrators. Predesigned Microsoft Power BI reports enable participating Eurocrine(R) clinics to self-audit their data.