Journal of Medical Internet Research

Background: Statins are key to preventing atherosclerotic cardiovascular disease and lowering low-density lipoprotein cholesterol and cardiovascular events. However, skepticism regarding their safety and value persists and is increasingly influenced by social media. TikTok has emerged as a major source of health information, but its content varies in quality and accuracy. This study evaluated the quality, attitudes, misinformation, and engagement of statin-related content on TikTok. Methods: Public TikTok videos were collected using predefined search terms and coded by creator type, thematic content, and overall attitude. Video quality was assessed using the DISCERN instrument, the Patient Education Materials Assessment Tool for Audiovisual Materials, and the Global Quality Score. False or misleading claims were independently reviewed by two cardiology fellows. Associations between engagement and quality were also examined. Results: Of 1,349 screened videos, 258 met inclusion criteria. Most were educational (91.0%), with non-physician healthcare providers (34.5%) as the largest creator group. Risks or negative effects were discussed more often than benefits (63.2% vs 42.2%), and 39.5% contained at least one false or misleading claim, most often from complementary and alternative medicine providers and wellness promoters. Quality differed by creator type across all instruments, with physician-created content scoring highest. Video popularity showed minimal association with informational quality. Conclusion: Statin-related TikTok content frequently emphasizes harms, often contains misinformation, and varies substantially in quality by creator type. Greater involvement of healthcare professionals on social media may help improve digital health literacy and counter misleading information about statin therapy.

Objectives: Older adults with comorbidities and polypharmacy have disproportionately high risk of hospitalization as well as readmission from adverse drug events (ADEs), of which 28%-71% are preventable (pADEs). This paper introduces an LLM application, CommunicADE, designed to support risk-mitigation of pADE-related readmission for the aforementioned population. We aim to evaluate CommunicADE's technical performance with OpenAI's HealthBench criteria: accuracy, completeness, communication quality, context awareness, and instruction following. Materials and Methods: Our technical validation study used an LLM (KimiK2.5) to simulate interviews between CommunicADE and nine high-fidelity synthetic patients hospitalized and at increased risk for pADE-related readmission (65+ years, comorbidities, 5+ medications). Some pADE risk mechanisms clues were visible to CommunicADE in patient H&Ps, but most mechanisms were solely discoverable in interviews. Two pharmacists evaluated CommunicADE's interview questions and EHR notes with HealthBench-informed variables. Analyzes used descriptive statistics. Results: For 35 mechanisms across 9 patients (avg=3.89 mechanisms/patient), CommunicADE's precision and recall were 0.92 and 0.63, respectively. Hallucinations were absent. Coherence and person-centeredness scored 4.28 and 4.44 on a 5-point scale (5=highest). On average, communication was at a 5th grade level and objective for 78% of patients. Most patient-reported quotes included in notes (92%) supported detected mechanisms. CommunicADE followed all instructions regarding interview length and patient approvals. Discussion: CommunicADE's strongest performance was in accuracy (precision, hallucinations), communication quality (coherence, readability), context awareness (person-centeredness). Completeness (recall) and instruction following (objectivity, pADE mechanism/quote alignment) show room for improvement. Conclusion: Findings suggest technical readiness for a feasibility pilot with real-world patients, and key areas for performance improvement.

Between 2024 and 2025, Colombia universalized the Electronic Health Invoice with embedded Individual Health Services Delivery Records (RIPS -- Registro Background Between 2024 and 2025, Colombia universalized the Electronic Health Invoice with embedded RIPS records (FEV-RIPS) as the standard for financial and clinical data exchange. ADRES -- the entity responsible for administering the resources of Colombia's General Social Security Health System -- faced the challenge of processing information from multiple heterogeneous sources generated by more than 55,000 healthcare providers. Health systems in high-income countries converge clinical-financial data in consolidated platforms; Colombia started from a fragmented architecture with incompatible historical sources, no cross-database standardization, and no centralized analytical infrastructure until 2023. Objective We describe the design, technical challenges of integrating heterogeneous data, and operational performance of the analytical infrastructure built by ADRES to centralize large-scale processing of Colombian health system information, and derive transferable lessons for health system resource administrators in Latin America facing equivalent digitalization mandates. Methods Technical-descriptive report based on operational metrics from the ADRES Azure/Databricks environment during January-November 2025. We report indicators of data volume, processing speed, computational capacity, concurrent use by functional group, and governance structure. The architecture integrates VPN connectivity with MinSalud, automated processing of multiple formats (XML, relational tables, flat files), and a medallion data lake (Bronze/Silver/Gold). Data quality challenges include structural inconsistencies across sources, coding incompatibilities (municipalities, dates, diagnoses), format heterogeneities in unstructured data, and absent technical documentation. Results The platform manages 21 catalogs, 1,183 tables, and over 110,645 million stored records, with cumulative production exceeding 1 trillion processed records. It executes queries on 100 billion records in ten seconds using clusters of up to 32 TB RAM and 4,096 vCPU. During September-October 2025, monthly query peaks reached 78,028 across eleven functional groups. Integration required Python/PySpark parsers for variable-depth XML, equivalence tables for incompatible municipality codes, cleaning routines for extreme dates used as nulls (1900-01-01, 9999-12-31), and transformation logic bridging classic RIPS and FEV-RIPS. The platform supported econometric analyses, judicial mandate responses, and public interactive dashboards. Conversational AI integration (Genie, Copilot) extends analytical access to users without SQL knowledge. Conclusions ADRES built in one year an analytical infrastructure that provides, to our knowledge, the first published documentation of the systemic technical challenges of integrating heterogeneous data sources in a middle-income social security health system. Centralizing health system information at national scale is technically feasible under public institutional constraints -- but requires solving cross-source standardization problems the implementation literature does not document with quantitative precision. The derived lessons are transferable to health system resource administrators in Latin America facing equivalent challenges.

Background Electronic health record documentation patterns may reflect workflow complexity, monitoring intensity, and operational strain in intensive care settings. However, documentation-derived features can be sensitive to local documentation culture, data capture systems, and outcome definitions. Retrospective validation across multiple datasets is therefore needed before these signals are used in workflow intelligence or clinical AI governance tools. Objective To evaluate whether documentation-density and documentation-timing features show reproducible retrospective signal for ICU workflow complexity and long-stay proxy outcomes across de-identified critical care datasets, while distinguishing workflow and long-stay associations from unsupported claims about mortality prediction, burden reduction, or deployment readiness. Methods We synthesized retrospective validation results from de-identified ICU and workflow datasets generated through a prespecified documentation-density validation program. Feature families included Documentation Burden Score style features, Shift-End Documentation Rate style features, documentation reliability style metadata, and all-documentation feature sets where available. Outcomes included long ICU length of stay proxies, mortality where available, and workflow proxy endpoints. Models compared baseline feature sets with enhanced models containing documentation-density or workflow features. Performance was summarized using area under the receiver operating characteristic curve, Brier score where reported, delta AUROC, bootstrap confidence intervals where reported, and label-shuffle controls where available. Results The strongest external long-stay proxy evidence came from the NWICU chartevents analysis, which included 28,612 ICU stays, 20,267 stays with chart events, and 9,619,759 chart events. For ICU length of stay greater than the median, baseline AUROC was 0.5252. Enhanced AUROC was 0.9512 for Documentation Burden Score features, 0.9214 for Shift-End Documentation Rate features, 0.8470 for documentation reliability style features, and 0.9517 for all documentation features. Corresponding label-shuffle enhanced AUROCs were near random, ranging from 0.4897 to 0.5064. For ICU length of stay greater than the 75th percentile, baseline AUROC was 0.5155. Enhanced AUROC was 0.9433 for Documentation Burden Score features, 0.9194 for Shift-End Documentation Rate features, 0.8118 for documentation reliability style features, and 0.9427 for all documentation features, with label-shuffle enhanced AUROCs from 0.4836 to 0.4999. Additional retrospective support was observed in eICU workflow analyses, HiRID first-24-hour documentation-density analyses, MIMIC-IV HF ICU internal analyses, MIMIC-IV-Note metadata extensions, and nursing-chart or lab density proxy analyses. However, cross-institution discrimination transfer was weak without recalibration, and several analyses remained proxy validations rather than final clinical validations. Conclusions Documentation-density and documentation-timing features show promising retrospective signal for ICU workflow complexity and long-stay proxy outcomes, especially in NWICU chartevents and selected internal dataset-specific analyses. These findings support further preregistered, prospective, silent-mode validation of documentation-derived workflow intelligence. They do not establish prospective clinical performance, mortality reduction, clinician burden reduction, autonomous deterioration prediction, or deployment readiness.

Background: Sleep fragmentation and reduced sleep efficiency are markers of disrupted sleep architecture linked to cognitive and age-related decline. Current assessments rely on subjective reports prone to recall bias, limiting their effectiveness for longitudinal monitoring. Data-driven analysis of sleep using physiological signals such as EEG and EMG remains underutilised, particularly in mid-to-older adults. Objective: We present a deep learning pipeline for automated sleep staging and label-free abnormality scoring, with the primary objective of quantifying deviations in sleep architecture to capture progressive sleep disruption and longitudinal change. Methods: Temporal and attention-based models were benchmarked using datasets from the National Sleep Research Resource and PhysioBank. To improve class-specific performance, we introduce a stacking-based ensemble of sleep stage classifiers, each trained to specialise in a different stage. For longitudinal scoring, we develop a reconstruction loss-based abnormality metric using a temporal convolutional autoencoder trained on hypnograms generated by the sleep staging models. Results: Attention-based models, particularly AttnSleep, achieved the highest performance in both multimodal and single-channel settings (accuracy: 0.85 and 0.83; F1: 0.79 and 0.74, respectively). The encoder-decoder ensemble model improved overall classification accuracy by 3% compared to the best-performing biased base classifier, with a modest gain in N1-stage F1 score (0.444). The proposed abnormality score correlated with Pittsburgh Sleep Quality Index components and showed sensitivity to synthetic hypnogram degradation, highlighting its potential as a label-free indicator of sleep disruption. Conclusion: Automated classification and annotation-free scoring enable an end-to-end multimodal pipeline that supports scalable, objective sleep health monitoring, with relevance for future clinical deployment.

Objective: To evaluate whether a locally hosted open-weight large language model (LLM) can extract documented psychosocial factors from pediatric psychiatric intake notes and apply validated extraction to a large emergency psychiatry cohort. Materials and Methods: We identified emergency department presentations at Cincinnati Children's Hospital Medical Center from January 1, 2016, through December 31, 2024, among patients younger than 18 years with psychiatric billing diagnoses. Using full-text intake notes, gpt-oss:120b classified peer conflict, sleep disruption, and school-related academic, attendance, and disciplinary issues as detected, negated, or indeterminate. Four human raters independently reviewed 50 notes. We compared Fleiss' kappa among humans alone versus humans plus the LLM, assessed repeated-query stability across 50 independent calls per note, and applied the workflow to all eligible notes. Results: Among 37,315 eligible admissions, 22,284 had eligible intake notes; 22,270 produced parseable JSON. In detected-versus-not-detected coding, human-plus-LLM reliability did not differ significantly from human-only reliability across measures (human {kappa} 0.71-0.94; human-plus-LLM {kappa} 0.70-0.93). Stability was associated with human agreement: mean LLM-human agreement increased from 42.6% for classifications with less than 80% stability to 82.7% for classifications with 100% stability (Pearson r = 0.36). Full-cohort extraction showed frequent and overlapping documented factors: sleep disruption was most frequently detected (57.7%), followed by peer conflict (47.2%), academic issues (43.4%), disciplinary issues (43.3%), and attendance issues (16.9%). Discussion: Agreement varied by construct and was strongest when repeated model outputs were stable. Conclusion: Locally hosted open-weight LLMs can support scalable structured extraction of documented psychosocial factors from pediatric psychiatric intake notes after local validation.

Background: Digital decision-support tools such as triage systems and symptom checkers support millions of health-related decisions each year. Their quality and safety are commonly evaluated using textual patient cases, known as case vignettes. However, existing vignette sets written by medical experts cover only a limited spectrum of real-world patient presentations and lack population weights, which would allow extrapolating evaluation results to the underlying patient population. Objective: This study aims to develop a data-driven framework for automatically generating a human-manageable set of case vignettes from nationwide triage data that captures broad presentation diversity and links each vignette to a quantitative weight reflecting the number of underlying patient assessments. Methods: From 3.2 million triage assessments conducted over one year using structured triage software in the German medical on-call service (telephone triage and online self-triage) and at the joint contact points of the outpatient emergency care service and hospital emergency departments, we randomly sampled 50,000 cases. Triage questionnaires were converted into semantic embeddings using a German Sentence Transformer Model and grouped by agglomerative clustering. For clusters containing sufficient assessments, we generated one representative assessment using a two-phase simulated-annealing optimization. The optimization minimized the distance to the cluster centroid while maximizing the number of answered triage questions, aiming for high representativeness and information content. Each representative assessment was assigned the size of its source cluster as its sample-based weight. A similarity-based sensitivity analysis was performed to examine whether these weights were preserved in the full 1-year population. Finally, the question-answer pairs of the representative assessments were converted into structured textual case vignettes using controlled prompting of a large language model. Results: The cluster analysis yielded 514 included clusters covering 96.8% of the sampled 50,000 assessments. The generated representatives showed strong agreement with the majority treatment-urgency recommendation of their source cluster (Spearman's {rho}=0.78, p<0.001) and contained on average 4.3 more answered triage questions than the original assessments within their clusters. When weighted by cluster size, the representatives approximated the sample distributions of treatment urgency, demographics, and symptoms, although some systematic deviations remained, most notably an overrepresentation of female cases (+13.5%), patients aged 14-49 years (+8.0%), and the urgency category "As soon as possible" (+6.6%). Of 121 recorded symptoms, 101 (83.5%) were covered by the representatives; the rest each occurred in <0.5% of the sample. In a sensitivity analysis, cluster-based vignette weights were strongly correlated with similarity-based population weights (Spearman's {rho}=0.77, p<0.001), and 90.1% of assessments in the full 1-year population were matched to at least one vignette. Conclusions: We present a data-driven framework for deriving a manageable set of population-weighted case vignettes from nationwide triage data. The resulting vignettes captured broad presentation diversity, approximated key sample characteristics, and provided an explicit quantitative link to the number of underlying patient assessments. After medical expert review and refinement, the vignettes may support more population-aware evaluation and quality assurance of digital decision-support tools.

Background. Capillary refill time, an examiner-dependent bedside test of distal microvascular perfusion, has become a resuscitation target in septic shock,1,2,3,4 motivating a continuous surrogate computed from the photoplethysmogram (PPG, the optical waveform the pulse oximeter on every ICU patient already records).5,6,7,8 Objective. We attempted three PPG-derived candidate measures on the MIMIC-IV Waveform Database (MIMIC-IV-WDB v0.1.0) and asked, by inspecting randomly drawn examples, whether each captured its intended physiology before any downstream modeling. Methods. MIMIC-IV-WDB v0.1.09 was linked to MIMIC-IV.10 The signals were a cuff-anchored perfusion-index recovery (reactive hyperemia when the cuff shares an arm with the probe), a slow Mayer-wave-band power ratio of the perfusion index (sympathetic vasomotor tone), and a per-beat diastolic exponential decay time constant (a refill-like recovery time). For each signal we drew 10 random examples at a fixed seed and checked them against a checklist fixed in advance. Each was read by the author and, separately, by MedGemma 1.5, a multimodal medical language model run locally. A synthetic test with a known time constant checked the third signal. Results. The cuff-anchored signal showed the expected occlusion-reperfusion shape on 268 of 6,236 evaluable cuff cycles (4.30%) in 15 of 19 patients, consistent with opposite-limb placement of the probe and cuff. The slow-band ratio returned a stable cohort value, but a clear, stationary peak appeared in only4 of 10 random windows. The per-beat fit met its goodness-of-fit threshold in 10 of 10 beats, yet a cardiac-frequency heuristic flagged a possible fit on the heart-rate oscillation in 7 of 10, and in 5 of 17 patients the time constant lay where an exponential is indistinguishable from a straight line. A 0.5Hz high-pass pre-filter implanted its own approximately 318 ms time constant regardless of truth. The language model tracked the human on clear positives but reported the pattern present on every call it returned, never absent. Conclusions. Two of the three candidate signals did not reflect their intended physiology in most examples, and the third was constrained by sensor placement. Inspecting a few random raw inputs against a checklist written in advance is an inexpensive upstream check before downstream inference on PPG-derived microvascular signals.

End-of-rotation handoffs are critical for patient safety but add to documentation burden for hospitalists. Generative artificial intelligence (AI) may help automate handoff creation using electronic health record data, but its impact on quality and safety is unclear. Methods: We developed an AI handoff tool with a large language model using clinical notes as input and conducted a retrospective evaluation comparing AI-generated and clinician-authored handoffs. Handoffs were assessed across domains of quality and safety through a structured review. Results: Quality ratings were similar between AI and human handoffs (3.7 vs. 3.5, p=0.57). AI-generated handoffs were rated higher for organization (4.4 vs. 4.1, p=0.05) and completeness (4.1 vs. 3.6, p=0.01), but lower for conciseness (3.7 vs. 4.1, p=0.03) and accuracy (4.1 vs. 4.4, p=0.03). Error rates were comparable (0.3/handoff in both groups); however, AI-generated handoffs included inaccuracies (9% of AI errors) and hallucinations (1% of AI errors), while clinician-authored handoffs contained only omissions. Conclusion: Human and AI handoffs have differing error profiles and tradeoffs between completeness and conciseness. Prospective evaluation in clinical workflows is underway.

Medical discrimination may alter how patients relate to health information sources following adverse care encounters. We examined whether discrimination experience is associated with selective erosion of institutional health trust and with compensatory digital health engagement, using nationally representative data from the Health Information National Trends Survey (HINTS) 6 (2022; n=6,252) and HINTS 7 (2024; n=7,278). Survey-weighted modified Poisson regression estimated prevalence ratios (PRs) for binary high-trust outcomes, and survey-weighted ordinary least squares estimated coefficients for continuous outcomes; jackknife replicate weights (50 replicates) provided variance estimates. Discrimination was associated with substantially lower probability of high trust in the healthcare system (PR=0.39; 95% CI 0.30-0.52) and physicians (PR=0.85; 95% CI 0.77-0.94), with no significant association for trust in scientists, government, family, or religious organisations. The clinical-institutional pattern replicated in HINTS 6, which additionally showed reduced trust in scientists for race/ethnicity-based discrimination. Contrary to a disengagement hypothesis, discrimination-exposed adults showed higher probability of online health information seeking (PR=1.06), health app use (PR=1.11), and online provider messaging (PR=1.13); these associations persisted after adjustment for trust in physicians. Discrimination was independently associated with lower health self-efficacy (b=-0.271). Medical discrimination selectively erodes trust in clinical institutions while leaving broader epistemic trust largely intact. Despite this, discrimination-exposed patients engage more actively with digital health channels, consistent with compensatory reorientation toward non-clinical information sources. These findings describe engaged but institutionally alienated patients, with implications for restoring clinical trust and for equity-centred digital health design.

Background Emergency department (ED) triage is a high-stakes clinical decision process that determines patient prioritization and resource allocation under time pressure. Large language models (LLMs) have recently been proposed as decision-support tools for triage, yet most evaluations rely on simulated scenarios or curated datasets. Evidence from real-world clinical environments remains limited. The objective of this project was to systematically evaluate the performance, calibration, and reproducibility of multiple contemporary large language models for Emergency Severity Index (ESI) classification and sectoral allocation (ED vs. urgent care practice, UCP) using a comprehensive real-world triage dataset. Material and Methods Retrospective cross-sectional benchmarking study conducted at a tertiary academic emergency ED in Germany with an integrated central point of assessment (CPA). The study included all consecutive adult walk-in encounters (>18 years) presenting between October 2023 and February 2024 (N = 16,107). Data were collected from a structured clinical decision support system capturing presenting complaints, vital signs, and triage decisions recorded by specialized nursing staff. Structured clinical variables routinely collected at triage, including presenting complaint categories (CEDIS-PCL), vital signs according to the ABCDE framework, and additional structured or free-text clinical information. Results The primary outcome was the agreement between LLM-predicted and nurse-assigned ESI levels measured using quadratic-weighted Cohen's k. Secondary outcomes included sectoral assignment agreement, misclassification patterns (over- and under-triage), calibration metrics, and output reproducibility. Quadratic-weighted k values ranged from 0.18 to 0.75 across models. Only a structured stepwise prompting strategy achieved substantial agreement (k_qw = 0.747), approaching reported human inter-rater reliability. Most models demonstrated moderate or lower agreement and systematic overconfidence, with expected calibration errors (ECE) based on verbalized confidence ranging from 0.099 to 0.355. Sectoral assignment agreement (i.e. ED vs. urgent care practice, UCP) was uniformly low (k < 0.30). Reproducibility testing revealed substantial variability in 23% of cases, indicating non-deterministic output behavior for clinically relevant decisions. Conclusions Current large language models demonstrate heterogeneous and generally limited performance in real-world emergency triage tasks. Structured algorithm-guided prompting appears more influential than model architecture or size. Before clinical implementation, improvements in calibration, reliability, and workflow integration are required, alongside regulatory-compliant validation in prospective clinical settings.

Machine learning (ML) has emerged as a transformative technology across biomedical and life science sectors, with applications spanning drug discovery, medical imaging, genomics, and clinical decision support (Goecks et al., 2020; Patel et al., 2020). Despite exponential growth in ML-related publications, from fewer than 100 articles in 2003 to nearly 25,000 by 2021 (NCBI, 2022), adoption among industry professionals remains uneven and sector-dependent. Understanding what drives or inhibits this adoption is critical for organisations seeking to leverage ML capabilities in research and clinical practice. Technology adoption in organisational contexts has been extensively studied through the Technology Acceptance Model (TAM), originally proposed by Davis (1989) and subsequently extended to incorporate external variables influencing perceived usefulness (PU) and perceived ease of use (PEU) (Venkatesh & Davis, 1996). While TAM has been applied across multiple industries, its application within biomedical and life science contexts remains limited, and the industry-specific factors that shape ML acceptance in this sector have not been systematically examined. Two external variables are particularly relevant to life science professionals. First, the bibliometric journal impact factor (JIF) functions as a cognitive signal of scientific credibility, a sector where evidence-based decision-making is culturally embedded, and publication quality serves as a proxy for technological legitimacy (Garfield, 1996). Second, technology hype, operationalised through the Gartner Hype Cycle framework, represents a social influence variable that shapes organisational expectations and investment decisions around emerging technologies (Gartner Inc., 2018). Whether these variables influence ML acceptance among life science professionals, alongside individual knowledge and experience, has not been empirically tested. This study addresses that gap by investigating ML technology acceptance among 213 biomedical and life science professionals across EMEA, LATAM, and North America, using a cross-sectional quantitative survey and PLS-SEM analysis. The TAM model is extended with three external variables, JIF, technology hype, and prior knowledge and experience, to test their influence on PU and PEU in this specific professional context. Additionally, the study examines demographic and regional differences in ML acceptance, with particular attention to variation between academic researchers and healthcare professionals. The findings contribute a validated, sector-specific extension of TAM for life sciences, provide actionable insights for organisations seeking to accelerate ML implementation, and establish a framework for future subsector-specific research.

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 [&ge;]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 [&ge;]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: Unstructured data represent about 80% of total electronic health records (EHR) data. Structuring this free text is essential for advancing clinical research, including cohort selection for trials, retrospective studies, and the development of disease registries. While manual chart review (MCR) remains the gold standard for extracting this clinical data, the process is inherently slow, resource-intensive, and susceptible to errors from human fatigue. We evaluated the extraction accuracy, safety, and efficiency of the HeLIX (Hepatology Logic-Integrated Extraction) framework, a Large Language Model (LLM) protocol using Google Gemini 3 Pro, compared to a gold-standard Manual Chart Review (MCR). Methods: A prospective validation study was conducted using 50 high-complexity, simulated hepatology discharge summaries designed to replicate the real-world heterogeneity of EHRs. The HeLIX framework employed a Zero-Shot, Structured Chain-of-Thought (CoT) prompting strategy enforced by a three-layer architecture: Clinical Reasoning Trace, Schema Enforcement, and Evidence Verification. The model extracted 45 distinct clinical variables. Performance was benchmarked against a consensus MCR. Results: Across 2,250 evaluated data points, the model achieved an overall Extraction Accuracy of 99.24% (95% CI: 98.8%-99.5%), with perfect concordance in 35/45 (77.8%) variables. For binary diagnostic variables, the model demonstrated an overall F1-score of 0.98, Recall of 0.99 and substantial inter-rater reliability (Cohens {kappa} = 0.97). Hallucinations were exceptionally rare (2/2250; 0.08%). Critical errors affecting clinical management occurred in only 2 instances (<0.1% of total data), both involving etiological misattribution in complex multifactorial diagnoses. The AI workflow was 13.4-fold faster and 95.1% more cost-effective than manual extraction. Conclusion: The HeLIX framework demonstrates physician-level accuracy and reliability in extracting complex hepatology data. It offers a scalable, efficient, and economical alternative to manual chart review. Such frameworks could accelerate clinical research, enabling healthcare systems globally to build comprehensive patient registries for a fraction of the traditional cost.

Objective: Clinical phenotyping methods that rely on clinical and informatics expertise can be time-intensive and costly. We tested both manual and highly automated approaches using electronic health record (EHR) data to identify an FDA Sentinel Initiative health outcome of interest, acute pancreatitis. Materials and Methods: We trained and evaluated machine learning algorithms using EHR data with two approaches: a custom approach that included manually curated features and trained on outcomes data validated with medical record review, and a highly automated approach that greatly simplifies and automates feature engineering and relies on low-cost silver-standard outcomes for model training. Results: Custom algorithms using manually curated structured claims data discriminated cases from non-cases with a high degree of accuracy (cv-AUC 0.89 [95%CI 0.84-0.94]); the inclusion of natural language processing (NLP)-derived covariates from clinical notes increased performance slightly (cv-AUC 0.91[95%CI 0.86-0.97]). The automated algorithm trained on the outcome count of diagnosis codes performed less well (AUC 0.80 [95% CI 0.75-0.85]) but improved using maximum lipase value as an outcome (AUC 0.88 [95% CI 0.84-0.92]). At a positive predictive value of 90%, the custom algorithm had a sensitivity of 92%, the automated algorithm trained on diagnosis code count had a sensitivity of 45%, and the automated algorithm trained on maximum lipase value had a sensitivity of 84%. However, a prediction rule derived by clinicians during chart review was nearly as accurate (maximum lipase value [&ge;] 3 times upper limit of normal; AUC 0.86, PPV 85%, sensitivity 92%). Discussion: Machine learning algorithms with manually curated structured data and NLP features trained on validated outcomes data successfully identified validated events. Use of an outcome in the automated model based on specific phenotype knowledge (maximum lipase value) allowed for performance similar to the custom model and with considerably less resources.

Objectives To explore caregiver and clinicians perspectives on implementing mental health conversations and supports for caregivers of children with chronic conditions in paediatric outpatient clinics. Specifically, views were sought on (a) screening approaches and measures (phase 1) and (b) how feedback and support could be provided to caregivers experiencing mental health difficulties (phase 2). Methods Caregivers and clinicians from two outpatient clinics (neuromuscular and diabetes) at a tertiary paediatric hospital in Melbourne, Australia participated in online focus groups in July and August 2024. Caregivers were recruited from outpatient clinics and clinicians were recruited via email. Both groups were combined for phase 1 before separating into breakout rooms for phase 2. Two authors conducted reflexive thematic analysis of transcripts using NVivo. Results Sixteen participants (caregivers n = 8; and clinicians n = 8) took part in in two semi-structured focus groups. Analysis generated two overarching domains, each comprising multiple themes. Domain 1, Addressing caregiver mental health, captured themes of overwhelm and invisibility, diverse caregiving roles, and the need for time and resources to support wellbeing conversations. Domain 2, Housing the mental health conversation, encompassed themes of screening preferences, caregiver agency in confidentiality, delivery of feedback, and access to tailored supports. Conclusions Caregivers and clinicians support routine caregiver mental health discussions in paediatric outpatient settings. Caregivers favour screening at diagnosis and key transitions, with clear, and actionable feedback delivered away from the child. Questions about record-keeping warrant further exploration, as do the perspectives of fathers.

Introduction Dysmenorrhoea is highly prevalent globally and interferes with engagement in education, work, social participation, and quality of life. Although evidence suggests that sociocultural beliefs influence how menstrual pain is understood and managed, relatively little research has explored dysmenorrhoea-related knowledge and beliefs within South Africa. This study aimed to (1) determine the frequency of dysmenorrhoea, (2) assess dysmenorrhoea-related knowledge and compare knowledge between menstruating and non-menstruating individuals, and (3) explore commonly held generational, cultural, and religious beliefs related to dysmenorrhoea in a South African university cohort. Methods We analysed data collected as part of a cross-sectional survey conducted among staff and students at a South African university. Participants completed demographic questions, items assessing dysmenorrhoea-related knowledge, and an adapted Working Ability, Location, Intensity, Days of Pain, Dysmenorrhoea (WaLIDD) questionnaire. Participants were also invited to provide free-text responses describing generational, cultural, and religious beliefs about dysmenorrhoea. Quantitative data were analysed descriptively and compared between menstruating and non-menstruating participants. Free-text responses were analysed using reflexive thematic analysis. Results A total of 863 participants completed the survey, including 578 current or past menstruators. The frequency (95%CI) of dysmenorrhoea was 75.4% (71.7-78.9). Most participants were classified as having moderate (53%) or severe (31%) dysmenorrhoea on the WaLIDD scale. Awareness of dysmenorrhoea was higher among participants who had menstruated than among those who had never menstruated (80.4% vs 55.3%, p<0.001). Most participants (85.1%) reported wanting more education about dysmenorrhoea and its impact. Reflexive thematic analysis of 246 free-text responses identified five themes: (1) menstrual pain is normalised, dismissed, and expected to endure, (2) reproductive meanings attached to menstrual pain, (3) moral, spiritual, and cultural interpretations of menstrual pain, (4) negotiating competing explanations for menstrual pain, and (5) managing and controlling menstrual pain symptoms. Across themes, dysmenorrhoea was interpreted through social, cultural, reproductive, spiritual, and biomedical frameworks that shaped how pain was understood, communicated, and managed. Conclusion Dysmenorrhoea is common in this South African university cohort, and is rarely understood as a purely biological symptom. Instead, menstrual pain is understood and managed through broader social, cultural, reproductive, moral, and biomedical narratives, which shape how pain is recognised, disclosed, legitimised, and treated. These findings highlight the importance of considering sociocultural beliefs alongside clinical factors when developing menstrual health education, support strategies, and healthcare services.

Background. Fairness-aware machine learning increasingly targets demographic performance disparities in clinical prediction, yet whether standard bias mitigation strategies genuinely improve equity in physiological signal analysis remains unclear. Age-based disparities in photoplethysmography (PPG)-based heart rate prediction present a particular challenge, as age-related performance differences may reflect context-dependent physiological structure rather than correctable artifacts. Methods. We evaluated three fairness interventions, inverse-frequency weighting (IF), Group Distributionally Robust Optimization (GroupDRO), and adversarial debiasing (ADV), applied via fine-tuning of a PPG foundation model across three clinical datasets spanning intensive care unit, laboratory, and consumer wearable contexts. Outcomes were assessed using a 2x2 framework classifying each intervention-dataset combination by the joint direction of change in mean absolute error (MAE) and fairness gap (FG) across age groups, yielding four outcome types: genuine improvement (G), leveling down (L), selective benefit (S), and both worse (W). Results. Across nine intra-domain conditions, no intervention simultaneously improved both MAE and FG (0/9 genuine improvement). The dominant pattern was leveling down (5/9): FG decreased but was accompanied by MAE degradation, indicating that apparent fairness gains were achieved at the cost of overall predictive performance. Age-group difficulty ordering varied across clinical contexts at baseline and was not preserved under intervention. In 18 cross-domain transfer conditions, genuine improvement was rare (4/18) and observed exclusively in non-MIMIC source configurations; models fine-tuned on MIMIC-sourced data yielded no genuine improvements (0/6). Embedding-level representation changes following fine-tuning did not reliably predict fairness outcomes. Conclusions. Age-based fairness interventions in PPG heart rate prediction indicate a leveling-down pattern rather than genuine equity improvement, suggesting that age-related performance gaps reflect context-dependent physiological structure not fully addressable through standard bias mitigation. Cross-domain transfer further amplifies this instability. These findings suggest that fairness evaluation frameworks for age-stratified physiological prediction should account for context-dependent performance structure rather than treating observed gaps as correctable bias.

Background Continuous health monitoring enables early detection of diseases and improves therapeutic outcomes. Non-intrusive biosignal sensors, such as capacitive ECG (cECG), offer a practical solution for daily monitoring in private environments, such as smart homes and vehicles. However, artifacts reduce signal quality and compromise reliability. Methods Following a registered report protocol (Warnecke JM et al. Plos One. 2021; 16(7):e0254780), we record data of 44 subjects and develop an artifact index for cECG. We use three signal quality indices (SQIs): the correlation of QRS complexes (corSQI), the R-peak detection consistency (bSQI) and the absolute amplitude ratio (aSQI). Our index classifies overlapping 10s segments with a step-width of 2s into clean or artifact segments. We label a 2s interval as artifacts if all five overlapping segments indicate artifacts. We record cECGs using an armchair with integrated electrodes in a single-arm study involving 44 subjects performing two activities -- reading and watching television (TV); for 11 minutes each. We record a time-synchronized reference ECG with skin electrodes on the chest. To evaluate the artifact index, we compare it with manually generated ground truth. Moreover, we evaluate the clothing materials cotton, linen, jeans, and polyester in 5 subjects. Results Watching TV results in longer, continuously clean signal durations than reading. On average, 88.3% of the signal has a minimum continuous clean duration of 10s, versus 79.8% during reading. All clothing configurations achieve a clean signal duration exceeding 10s. Among the SQI metrics, bSQI performs best, achieving an accuracy of 90.7% and an F1 score of 79.9%. Combining the three SQI metrics in a voting approach improves accuracy to 92.0% and F1 score to 82.1%. Discussion Our artifact index automatically distinguishes clean from artifact cECG segments, promoting health monitoring in unsupervised real-world settings, earlier disease detection, and preventive health management. A limitation is the investigation of only two scenarios (reading and watching TV).

Background: Machine learning models for stroke mortality prediction typically treat each time horizon independently and use flat tabular features that ignore the relational structure of electronic health records (EHRs). In this pilot study, we leveraged graph-based machine learning models to predict post stroke all-cause-mortality across three different time horizons. Methods: We developed Stroke Temporal Heterogeneous Graph (StrokeTHG), a heterogeneous graph neural network model for simultaneous multi-horizon stroke mortality prediction (30-day, 90-day, 1-year) using EHR data from Penn State Health System. The model encodes various relations among EHR entities (e.g., patient, diagnosis, comorbidity) and temporal encoding of admission time to better predict stroke mortality. We compared our proposed approach against various baseline methods, including Logistic Regression, Random Forest, and XGBoost. We also performed ablation and subgroup analyses, evaluated the quality of learned graph embeddings, and assessed the importance of different edge types in the graph. Results: We included 4,144 stroke patients (mean age 69.2 years; 54.3% men), of whom 3,332 (80.4%) survived their stroke after one year. 30-day, 90-day, and 1-year mortality rates were 9.7%, 13.7%, and 19.6%, respectively. Our proposed approach, StrokeTHG, achieved AUROC of 0.872, 0.878, and 0.837 across horizons, outperforming all tabular baselines. At [&ge;] , 75% specificity, the model identified 5-10 percentage points more mortality cases than the best baseline at each horizon. Subgroup analysis demonstrated consistent performance across sex subgroups and the largest discriminative gains in the Age 65-80 stratum. Edge-type ablation identified phenotype-patient and admission-patient edges in the constructed EHR graph as the most influential relational edges for mortality prediction. StrokeTHG embeddings outperformed all graph and matrix factorization baselines under an identical downstream classifier, confirming that performance gains stem from representation quality rather than classifier capacity. Conclusions: StrokeTHG demonstrates that heterogeneous graph representations of EHR data provide a consistent improvement over flat tabular models for multi-horizon stroke mortality prediction, with particular advantage at clinically actionable sensitivity thresholds and novel multi-horizon monotonic prediction capability. This methodological framework may be adaptable to other EHR-based clinical research studies seeking to leverage heterogeneous relational structures for predictive modeling.