Molecular Tumor Boards (MTBs) generate highly technical recommendations. The language used in their protocols is rarely accessible to patients. Lay-language patient protocols could support patient-clinician communication, yet manual production is difficult to sustain in high-volume oncology settings. Large language models (LLMs) may offer scalable drafting assistance, yet clinical usability remains largely uninvestigated under real-world deployment constraints. Existing evaluations rely predominantly on synthetic data or closed-source models that are incompatible with strict data protection requirements. This study evaluated whether open-weight LLMs can provide clinically usable drafting support for German MTB patient protocols under real-world deployment constraints and developed a transferable evaluation framework for patient-facing text generation. Eight open-weight LLMs were evaluated under zero-shot (A1) and one-shot (A2) prompting with constrained decoding, which ensures section-schema compliance. Automatic evaluation used ROUGE-1 (Recall-Oriented Understudy for Gisting Evaluation), BERTScore-F1 (Bidirectional Encoder Representations From Transformers Score), Wiener Sachtextformel version 4, and DistilBERT (Distilled Version of Bidirectional Encoder Representations From Transformers)-based complexity using a corpus of 316 MTB protocols and 47 expert-written patient protocols. For expert evaluation, 7 medical oncologists evaluated 50 protocols from the best-performing model across 3 International Organization for Standardization 9241-11 usability dimensions using fine-grained error annotation, perceived postediting effort (PPEE), and net promoter score. Critical errors were defined as bearing the risk of patient harm. Llama-3.3-70B-Instruct achieved the strongest automatic performance. Across models, A2 significantly improved most automatic metrics compared to A1. However, expert usability evaluation of Llama-3.3-70B-Instruct showed the opposite picture: the proportion of protocols containing at least 1 critical error doubled under A2 (10/25, 40% vs 5/25, 20%) compared with A1, and the dominant error type shifted from language (40/108, 37%) errors to factual errors (69/145, 48%). Overall, 16% (230/1420) of the annotated paragraphs contained errors. Median PPEE was 2 (IQR 2.0-3.0; low), and median net promoter score was 7 (IQR 5.0-9.0). Detractors (46/100, 46%) outweighed promoters (29/100, 29%), which suggests hesitation toward routine adoption. These differences in expert evaluation between A2 and A1 were directionally consistent but did not reach individual statistical significance for the paired samples (n=25). Prompting strategies that improve automatic metrics can simultaneously increase the number of critical errors. Surface-level metric gains were, therefore, insufficient proxies for clinical safety. This was observed as a consistent directional pattern for a single model, but generalization to other models remains to be investigated. Nonetheless, the low paragraph-level error rate and favorable PPEE suggest that structured open-weight LLM generation may be a useful drafting support in a clinician-supervised setting. The proposed evaluation framework provides a text-quality-focused basis for future assessment of patient-facing LLM applications in real-world clinical settings.
Implementation science (IS) plays a critical role in translating research into real-world health outcomes. Few studies have evaluated models that provide technical assistance and other resources to build IS capacity. The Coordinating and Capacity-Building Hubs to Enhance the Science of HIV Implementation Research (CHESHIRE) network supports US-based HIV research awardees participating in the Ending the HIV Epidemic in the US (EHE) initiative. The objective of this study is to describe the evaluation protocol for CHESHIRE and assess the effect of the implementation of hub technical assistance activities on EHE-funded research team outcomes, including IS competencies, scientific collaboration, and research productivity. This protocol describes a mixed methods evaluation using qualitative interviews with EHE project leads (n=36); social network analysis of CHESHIRE-affiliated researchers and hub members (n=265); and secondary data analysis of National Institutes of Health (NIH) RePORTER, PubMed, and NIH Implementation Science Coordination Initiative EHE Project Final Progress Report Survey data (n=248). We will use descriptive analyses, network metrics, and thematic coding to describe outcomes following CHESHIRE implementation, including IS competencies, interinstitutional partnerships, and research productivity. CHESHIRE coordinating center and hub activities were funded through NIH Center for AIDS Research and AIDS Research Center supplements beginning in 2019, with hubs funded between 2019 and 2024. Available survey data include EHE projects that completed the EHE Project Final Progress Report Survey between August 2021 and February 2025. As of January 2026, we have completed enrollment, with 265 network members in the final recruiting list. Data abstraction and analysis of the evaluation components are ongoing. Publication of findings is anticipated for December 2026. Evaluation findings will be disseminated after completion of data analysis. The findings will provide insights on whether structured IS support through CHESHIRE increases researchers' IS competencies, interinstitutional partnerships, and research productivity. This evaluation will provide empirical evidence to guide the development and optimization of technical assistance hubs in public health research and inform their future evaluation of hub-based IS capacity-building models. Findings will inform strategies to optimize IS capacity building and accelerate the translation of evidence-based interventions into practice, especially in HIV prevention and treatment. DERR1-10.2196/91374.
Sleep disorders represent a significant public health burden associated with cardiovascular and neurocognitive morbidities. While AI technologies offer potential for personalized sleep medicine, clinical integration remains limited. This translational disparity is often attributed to a lack of human-centered design, specifically insufficient stakeholder engagement in the development and implementation of these technologies. Current research frequently prioritizes algorithmic performance over usability and patient trust. This scoping review systematically maps the extent and nature of human-centered AI (HCAI) research within sleep medicine across different AI modalities, evaluating how diverse stakeholders are involved in the design, validation, and implementation of AI tools, including patients, clinicians, and technologists. Following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, we searched 8 databases (PubMed, Web of Science, Embase, Scopus, IEEE Xplore, ACM Digital Library, APA PsycINFO, and CINAHL) for literature published up to June 18, 2026. We identified primary research describing the design, development, or evaluation of AI technologies for sleep health with explicit human-centered components. Included studies (n=34) were categorized based on AI technology type and the method of stakeholder engagement. Data were extracted and synthesized using a thematic analysis approach. Based on the included studies, the analysis reveals an uneven distribution of research focus across technological domains as descriptive patterns rather than definitive trends. Research on generative AI (GenAI) is predominantly restricted to downstream expert auditing of output accuracy (comprising 7/11, 64% of GenAI studies), with a noticeable gap in upstream participatory design involving patients. Conversely, deep learning research primarily focuses on technical explainable AI methods to address algorithmic opacity for clinicians, yet lacks progression to real-world clinical implementation. Mobile health and wearable technologies (17/34, 50%) demonstrate the most balanced HCAI ecosystem, evidencing a complete translational cycle from upstream co-design to downstream clinical implementation. Furthermore, an emerging trend is observed where AI is evolving from an automated diagnostic tool into an interactive therapeutic agent, with recent studies indicating that lay users may perceive responses from large language models as more empathetic than those from physicians. Lacking formal quality appraisal, our findings reflect research activity patterns rather than confirmed clinical effectiveness. Nevertheless, this scoping review innovatively applies the HCAI framework to the sleep AI lifecycle. Unlike existing reviews prioritizing algorithmic performance metrics over usability, clinical workflow integration, and patient trust, this study systematically maps these essential sociotechnical factors. It contributes to the field by revealing distinct methodological disparities and the urgent need for upstream participatory design, particularly for GenAI. In the real world, establishing standardized protocols for human-AI interaction, ensuring algorithmic transparency, and addressing demographic biases are essential to foster the clinical trust required for effective AI adoption.
Alcohol use disorder (AUD) is a complex, chronic medical disease wherein patients have traditionally benefited from a multidisciplinary and comprehensive therapeutic approach, including a comprehensive treatment plan that addresses the psychological, behavioral, and social dimensions of the individual. Holistic health is a nontraditional system of wellness that focuses on well-being through body, mind, and spirit and aims to restore balance through combined physical, mental, and emotional care. This approach may incorporate nonpharmacological and alternative treatments alongside allopathic medicine. In recent years, there has been a growing interest in integrating holistic health strategies into addiction treatment. The primary objective of this scoping review is to identify and characterize holistic health interventions currently used in the management of people with AUD. A secondary objective is to collate the reported efficacy of these interventions. Additionally, this review will identify gaps in the literature and suggest areas for future research. This review will adhere to the Arksey and O'Malley methodological framework for scoping reviews. Published research and pilot clinical trials reporting on holistic health interventions in AUD will be included. Five databases will be searched: PubMed and MEDLINE, Embase, CINAHL, Web of Science, and Scopus. There will be no date restrictions, though only English-language articles will be included. To qualify, studies must include at least one holistic intervention (eg, meditation, homeopathy, and special diets). Excluded studies will include those that do not involve people with AUD and/or hazardous drinking or that only test pharmaceutical treatments without a holistic component. Two reviewers will independently screen and extract data with a third reviewer as a tiebreaker; discrepancies will be resolved through discussion. This scoping review began in Covidence in December 2024 and is currently funded by the National Institutes of Health Intramural Research Program. Data collection was completed in February 2026, and data analysis was completed in June 2026. Results are expected to be published in late 2026. This review will provide an overview of holistic approaches and interventions used in AUD treatment. It will highlight gaps in the literature and recommend directions for future research. Results will be submitted for publication in a peer-reviewed journal. No ethics approval is required because the review involves only publicly available literature.
African American and Black women are among the least physically active demographic groups in the United States and experience disproportionate burdens of chronic disease that may be reduced through regular physical activity (PA). Mixed methods research is increasingly used to examine the behavioral, social, and contextual factors that influence PA in this population. This study aims to identify, examine, and describe the mixed methods designs used in research on PA practices among African American and Black women in the United States; compare methodological approaches; identify gaps in the literature; and provide recommendations for future research. This scoping review will follow Joanna Briggs Institute methodology. A 3-step search strategy was developed and peer reviewed using the Peer Review of Electronic Search Strategies guideline. Seven databases will be searched: Academic Search Ultimate, Agricultural and Environmental Science Database, APA PsycINFO, CINAHL Ultimate, PubMed, SocINDEX, and SPORTDiscus. Eligible studies will be primary mixed methods investigations involving non-Hispanic African American or Black women aged ≥18 years residing in the United States. Studies must include both quantitative and qualitative components with evidence of integration. Records will be deduplicated and screened in Rayyan according to population, concept, and context eligibility criteria. Data will be summarized using descriptive statistics, tables, and an evidence map. The review will be limited to English-language studies published from February 1, 2011, through February 18, 2026. The protocol was registered with the Open Science Framework. The search strategy was piloted, refined, and finalized on February 18, 2026. Database searching has been completed, records have been imported and deduplicated, and screening is currently ongoing. Data extraction and synthesis have not yet commenced. Completion of study selection, data charting, and synthesis is anticipated by August 2026, with submission of the completed scoping review planned thereafter. This review will provide a methodological map of mixed methods studies examining PA among African American and Black women, including design types, integration strategies, timing, prioritization, use of joint displays, and reporting practices. Findings will inform future mixed methods research and support the development of more rigorous and transparent investigations in this field. Open Science Framework 10.17605/OSF.IO/NA9ME; https://osf.io/na9me/overview. PRR1-10.2196/93012.
Supporting youth and their caregivers during the transition from pediatric to adult health care is a priority across Canada. Many transition in care (TiC) innovations exist, yet these innovations often fail to be effectively implemented and/or sustained. Knowledge translation (KT) interventions, such as developing educational materials and identifying champions, are used to promote the uptake of innovations into clinical practice. However, there is limited information on what, when, and how these KT interventions are used to implement and sustain TiC innovations. This paper presents the protocol for a realist review aiming to understand what KT interventions work, how they work, for whom, and under what circumstances to support the implementation and sustainability of TiC innovations for youth moving from pediatric to adult health care. The objectives are to (1) identify and map KT interventions and (2) develop initial program theories. We will follow Pawson's 5 iterative steps for realist reviews, integrating aspects of rapid realist review methodology. We will adhere to the RAMESES (Realist and Meta-narrative Evidence Syntheses-Evolving Standards) quality standards for realist synthesis. Using an integrated KT approach, we will leverage the lived and professional expertise of a team of knowledge users and researchers. This project has received funding from Canadian Institutes of Health Research, starting in January 2026. A research partner team of 24 people with lived and professional expertise in transition has been assembled, as well as a team of 18 scientific members. Step 1 of the review is underway. The review is anticipated to be completed within 12 months. Using a theory-driven approach, this realist review will result in initial program theories about the underlying mechanisms, contextual factors, and processes within KT interventions that influence implementation and sustainability outcomes of TiC innovations for youth and their caregivers. A subsequent explanatory mixed methods realist evaluation with a multiple comparative case study design will test and refine initial theories. This research will be important to inform future TiC innovations for diverse health contexts across Canada and beyond.
Therapist-guided internet-delivered cognitive behavioral therapy (guided iCBT) is increasingly implemented in routine mental health care to expand access to evidence-based treatments. Although the clinical effectiveness and patient acceptability of guided iCBT for common mental health disorders are well established, less is known about how introducing such digitally mediated interventions reshapes therapists' everyday work practices and professional roles. Existing research has primarily focused on treatment outcomes, service uptake, and organizational implementation challenges, leaving therapists' lived professional experiences and role enactment in routine practice underexplored. This study aimed to explore how the introduction of guided iCBT in routine clinical practice influences mental health care professionals' perceptions and enactment of their professional roles, and to examine how these roles are shaped by interactions between technology and health care professionals. We conducted an exploratory qualitative study using semistructured interviews and observations with 31 health care professionals who delivered guided iCBT in specialized mental health care settings between January and December 2022. Participants were recruited through purposive and snowball sampling, and data were analyzed using reflexive thematic analysis. The study was theoretically informed by actor-network theory and sociological perspectives on professional roles, enabling a sociotechnical interpretation of how professional work is shaped through interactions between human and nonhuman actors. Two overarching themes described how guided iCBT reconfigures therapeutic work. First, participants reported increased professional agency through enhanced flexibility and autonomy, including greater control over work schedules and opportunities to tailor standardized treatment elements to individual patients. Second, the therapist's role expanded beyond traditional clinical tasks, encompassing increased administrative responsibilities ("the administrative therapist") and expectations to actively promote and legitimize guided iCBT to patients ("the professional salesperson"). While guided iCBT enabled more flexible and individualized care, it also introduced new constraints through standardized protocols, digital platforms, and organizational expectations, resulting in professional discretion and authority being actively negotiated rather than simply reduced or maintained. This study offers a practice-oriented, sociotechnical account of how guided iCBT is implemented in routine care. The findings show how therapists' roles are shaped by everyday clinical workflows, in which responsibility, decision-making, and clinical judgment are distributed among therapists, patients, digital platforms, treatment protocols, and organizational arrangements. The concept of distributed therapeutic authority offers a useful lens for understanding how therapeutic work is reorganized in digitally mediated care without implying a loss of professional expertise. Professional judgment remains central but is exercised in interaction with digital tools and standardized treatment structures. These findings underscore the importance of aligning digital systems, clinical routines, and professional roles when implementing guided iCBT to support both access to care and the quality of therapeutic practice.
TikTok is one of the fastest-growing social media platforms in the world. It has become an important space for sharing information on a wide range of topics, including medical conditions such as atopic dermatitis (AD). Advice on skin conditions has become popular on TikTok, and most previous research in this area focuses on the credibility of the information being shared. However, little research has focused specifically on physician-created videos and their audience engagement and interaction. Our study aimed to (1) characterize the audience's online response to board-certified physicians' TikTok content related to AD according to established protocols and (2) better understand the interactions that happen among members of the audience in the comment section of this content. In December 2023, searches were conducted for the terms "atopic dermatitis" and "eczema" on 3 unique TikTok accounts to identify videos created about AD by board-certified dermatologists. A total of 28 final videos were analyzed and classified into the following categories: (1) explanation of disease, (2) recommendation, (3) debunking misinformation, and (4) informal or anecdotal. The top 50 original comments on each of the 28 videos were collected and classified into one of the following categories: (1) "positive personal experience," (2) "negative personal experience," (3) "neutral personal experience," (4) "requesting advice," (5) "learning," (6) "appreciative reaction," (7) "critical reaction," (8) "giving advice," (9) "humor," (10) "tagging another user," and (11) "off-topic." Replies to comments were also analyzed and grouped into similar categories. Video category did not have a significant impact on engagement rate (P>.99). Across all video categories, comments that involved personal experiences or sharing information made up a larger percentage than those that were critical or off-topic (P<.001). Of the comments related to personal experience, the percentage of negative personal experience comments was significantly higher than that of positive personal experience comments (P=.001). Among replies to comments, "recommendation" and "emotional support" replies were significantly more common than other types of replies (P<.001). Our study suggests that videos created by dermatologists on TikTok are generally well received regardless of video style or category. The comment sections appear to provide transient supportive environments where users connect over shared challenges and exchange personal experiences and recommendations. There is a gap in dermatologist-produced TikTok content involving darker skin tones.
Cardiovascular disease (CVD) is a leading cause of morbidity and mortality in the Middle East and Africa (MEA), with a rising incidence particularly among women. Regional factors such as limited health care access, cultural barriers, and sex-specific risk factors exacerbate this burden. Despite this, women remain significantly underrepresented in cardiovascular research, and no large-scale, multicenter prospective trials have been conducted to provide national data. To address this gap, we established the Middle East African Registry Women Cardiovascular Disease (MEA-WCVD) to create a comprehensive database on the epidemiological profile and management of heart failure (HF), atrial fibrillation (AF), ischemic heart disease (IHD), and valvular heart disease (VHD) in women. The primary aim of this study is to compare the management of CVDs in women and men across MEA countries in accordance with current clinical practice guidelines. The study also seeks to identify gender-based disparities in health care insurance, income, and access to cardiovascular services. The MEA-WCVD is a prospective, multicenter, observational study enrolling consecutive patients aged ≥18 years with diagnosed HF, AF, IHD, or VHD across 25 tertiary care centers. Participants provide informed consent during a single visit, and trained investigators collect sociodemographic, clinical, and treatment data via electronic case report forms. The electronic case report form captures general characteristics (age, gender, and comorbidities) and diagnosis-specific details (imaging, guideline-based therapies, and complications). Data are stored in a centralized, contract research organization-managed database (Eshmoun-Clinical Research, Tunisia). An initial 75-day enrollment phase (May 2023-July 2023) is followed by a planned 1-year follow-up for outcome analysis. Data will be analyzed using SPSS (version 25) to compare gender disparities in management and outcomes using multivariable regression and survival analyses. The MEA-WCVD study was funded in April 2023, and data collection began in May 2023. As of July 2023, a total of 15,366 participants have been enrolled across 25 centers. A 1-year follow-up is expected to be completed by July 2024. Data analysis is planned to commence in July 2024, with primary results anticipated for publication in March 2025. The study aims to establish the largest registry in the MEA region for HF, AF, IHD, and VHD, providing valuable insights into demographic trends, clinical management, and adherence to current guidelines. The MEA-WCVD registry will provide essential real-world data on the management and outcomes of the most prevalent CVDs (HF, AF, IHD, and VHD) in the MEA region. By directly comparing standard care management between men and women, this study will highlight gender disparities and inform future strategies for equitable cardiovascular care. The registry is expected to contribute to the largest contemporary cohort of patients with CVD in the region, advancing knowledge in cardiovascular epidemiology and clinical practice.
With shorter window periods than serologic point-of-care (POC) tests and faster turnaround than laboratory-based nucleic acid tests (NAT), POC NATs could improve early detection of HIV. Furthermore, semiquantitative POC NAT may provide real-time monitoring for persons with HIV. There have been limited evaluations of POC NAT implementation in the United States. This paper describes the protocols and procedures used to evaluate the acceptability and feasibility of POC NAT implementation and test performance in clinical and community settings in Seattle, Washington. The Greater Access and Impact through POC NAT (GAIN) study was a Centers for Disease Control and Prevention-funded study that enrolled participants at a Ryan White-funded, hospital-based clinic (Madison Clinic) and a community site (Seattle's LGBTQ+ Center [the Center]). Persons seeking HIV testing, nonoccupational postexposure prophylaxis, or pre-exposure prophylaxis (PrEP) enrolled at either site received the standard of care plus the SAMBA II HIV-1 Qualitative Whole Blood Test (SAMBA Qual) and pooled laboratory HIV NAT, and persons with HIV enrolled at the Center received standard-of-care sexually transmitted infection testing plus the SAMBA II HIV-1 Semiquantitative Whole Blood Test (SAMBA Semi-Q) and laboratory viral load testing. Persons with HIV from Madison Clinic were recruited into a randomized clinical trial (RCT) to compare the clinical standard of care with the addition of the SAMBA Semi-Q (backed up by Food and Drug Administration-approved laboratory NAT). All participants completed a demographic survey during their study visit and contributed prospective data via electronic medical records. Subsets of participants from each group were invited to complete a postvisit acceptability survey and participate in an individual interview. Patient flow was observed at Madison Clinic to assess the impact of POC testing on clinic visit timing. From January 2022 to December 2024, 733 participants completed 753 GAIN research visits. Of those, 491 visits were completed by 489 participants seeking HIV testing and/or PrEP at the Center, and 61 visits were completed by 43 participants seeking HIV testing, nonoccupational postexposure prophylaxis, and/or PrEP at Madison Clinic. Test result data will assess test performance, with analyses anticipated in 2027. Seven people with HIV were enrolled at the Center, and 194 people with HIV were enrolled in the Madison Clinic RCT. Data from patients with HIV at Madison Clinic will be used to conduct a survival analysis evaluating the impact of POC NAT on time to viral suppression and to assess test performance, with analyses anticipated in 2026. In-depth acceptability surveys were completed by 193 participants, and 41 interviews were conducted. These data will contribute to qualitative and mixed methods analyses, which are anticipated in 2026. Time-and-motion observations conducted in 2021 and 2023 included 47 patients; results are anticipated in 2026. The GAIN study is an important evaluation of POC NAT implementation in the United States in community and clinical care settings for HIV diagnosis and viral load monitoring. Results will be reported in future publications.
Nurse-initiated management of antiretroviral therapy (NIMART) has expanded access to life-saving antiretroviral therapy and enhanced the decentralization of HIV care. The psychobiological and psychosocial responses of nurses implementing this strategy have been largely underexplored. This scoping review aims to systematically map the extent, nature, and characteristics of the existing literature on the psychobiological and psychosocial responses of NIMART-trained nurses providing care to people living with HIV. The review will be conducted in accordance with the Joanna Briggs Institute methodology and the population, concept, and context (PCC) framework, which will guide the development of the review question and define the eligibility criteria. A comprehensive search strategy will be used to identify empirical studies published between 2010 and 2026 across electronic databases (PubMed, SABINET, PsycInfo, CINAHL, Scopus, and Google Scholar). Two independent reviewers will screen the titles and abstracts to determine which studies are eligible. If there is any disagreement, a third reviewer will resolve it. Data will be analyzed using narrative synthesis and thematic mapping to identify patterns, knowledge gaps, and implications for future research, practice, and policy. The review is expected to identify the scope, trends, and gaps in the literature on psychobiological and psychosocial responses among NIMART-trained nurses. The estimated outcomes will include a synthesis of existing evidence. The scoping review was initiated in July 2025, and is expected to be completed by the end of July 2026. This scoping review will provide an evidence-based understanding of the psychobiological and psychosocial responses of NIMART-trained nurses, highlighting implications for policy, practice, workforce support, and future research.
Older adult care systems face severe workforce shortages, rising demands, and high levels of stress and burnout, undermining the quality of care and organizational resilience. Support4Resilience (S4R, 2024-2028) aims to improve working conditions and mental well-being by equipping leaders with an evidence-based, organizational-level intervention. The project develops and evaluates a digital S4R Toolbox consisting of 3 tools: (1) mapping and identification (MAP); (2) reflection and education (IMPROVE); and (3) reorganization (REMOVE). The project aims to strengthen resilience and mental well-being among health care workers and informal caregivers in older adult care across Europe and Australia through the development and implementation of the digital S4R Toolbox. Secondary objectives are identifying determinants of resilience and mental well-being across diverse contexts; exploring needs and perspectives that inform successful adaptation to changing working conditions and ethical challenges; designing the S4R Toolbox; evaluating its relevance, effectiveness, and cost-effectiveness across health care systems; advancing theory on the relationship among individual resilience, organizational resilience, and leadership; and producing research-based recommendations and interventions through the open-access S4R Resource Bank. S4R applies an exploratory, longitudinal, mixed-methods co-design approach across 4 phases. The input phase gathers evidence through literature reviews, context mapping, and qualitative and quantitative data collection in 7 countries. The co-design and prototype testing phase involves developing the S4R Toolbox and conducting pilot testing. The implementation, evaluation, and finalization phase includes a 1-year implementation period, followed by process, effectiveness, and cost-effectiveness evaluations and final refinement of the Toolbox. The output phase disseminates the results through the open-access S4R Resource Bank. The project has achieved substantial early progress, including 5 literature reviews, completed and published context mapping, and comprehensive data collection involving health care workers, leaders, and informal caregivers in 7 countries. Toolbox development is well advanced, and pilot testing has been completed. S4R will deliver a research-based digital Toolbox that supports leaders in strengthening the resilience and mental well-being of health care workers and informal caregivers in older adult care. By integrating the perspectives and experiences of leaders, health care workers, and informal caregivers, identifying resilience factors, and developing theory-informed, cost-effective interventions, S4R will provide actionable resources through an open-access platform, contributing to more resilient older adult care systems. ClinicalTrials.gov NCT07504042; https://clinicaltrials.gov/ct2/show/NCT07504042. DERR1-10.2196/73701.
From July 2024, Australian pharmacists are remunerated through federal funding to practice on-site within aged care homes. This Aged Care On-site Pharmacist (ACOP) program is novel in both Australian and international practice, aiming to improve the quality use of medicines for vulnerable older persons through medicines governance, person-centered medication reviews, and more. In this program, pharmacists are embedded in facilities and health care teams, varying from historical Australian models where they are visiting health care professionals. Distinct from pharmacist practice in hospital and community pharmacy, the role is professionally isolated from other pharmacists, limiting opportunities for peer collaboration and practice-specific professional development. Peer learning, mentorship, and workplace-based learning opportunities are considered integral for health professional development. This project aims to co-design a training program that provides a pathway to professional development for ACOPs aligned with the diverse interests of stakeholders, including health care professionals, residents, and informal caregivers. Focus group-style co-design workshops and stakeholder consultations will be used in this project. The "Double Diamond" framework will be used to structure the process, using 4 stages of alternating convergent and divergent exploration of stakeholder perspectives. A consumer advisory group has been engaged, consisting of persons with lived experience of aged care settings, for consistent observation and overarching guidance of the project. Exploratory workshops with pharmacists, allied health and medical professionals, residents, and families of residents will be conducted. Workshops will be audio- and video-recorded, transcribed verbatim, and analyzed using thematic analysis. Insights obtained from overarching themes as well as individual perspectives will be used to design a pilot program, which will be presented and discussed for feedback during follow-up focus groups. A pilot phase will then be undertaken with ACOPs, who will be further involved in feedback and workshop-style focus groups to collaboratively refine the program. Funding for this project was granted through the Medicines Research Future Fund on March 27, 2023. Recruitment for preliminary phases began in January 2025, and data collection began in March 2025. Data collection is expected to end in October 2026. Ethics approval for this study was granted on December 19, 2024, by the University of South Australia Human Research Ethics Committee. Recruitment has exceeded the initial estimates of minimum participant involvement. Output data are expected to be available in early 2027. This will be the first co-designed workplace-based training program available for pharmacists undertaking the novel and complex role of ACOPs. It is expected to benefit the development of clinical and nonclinical skills, facilitate integration into existing teams, and offer a pathway to professional recognition.
Pharmacotherapy for common mental disorders is frequently limited by adverse events and suboptimal adherence. While music therapy offers a promising nonpharmacological alternative, its clinical utility is currently constrained by limited accessibility, inconsistent efficacy, and a lack of mechanistic clarity. This study aims to describe the development of individualized (receptive) music therapy (IMT), an artificial intelligence (AI)-enabled, neuroscience-guided intervention, and to evaluate its efficacy, safety, and underlying neurobiological mechanisms in adults with major depressive disorder, generalized anxiety disorder, and primary insomnia. This multistage research program is being conducted at Peking Union Medical College Hospital and comprises four sequential studies: (1) a cross-sectional pilot study (n=20) to benchmark clinical and electroencephalography features, (2) a prospective cohort study (n=80) evaluating the efficacy and safety of nonindividualized receptive music therapy, (3) a pilot randomized clinical trial (n=300) comparing nonindividualized therapy with IMT over 8 weeks, and (4) a prospective validation study (n=60) of a treatment-response prediction model. Participants include adults aged 18 to 60 years with mild-to-moderate major depressive disorder, generalized anxiety disorder, or primary insomnia, along with healthy controls. In the nonindividualized arm, participants engage in daily 30-minute listening sessions using therapist-curated instrumental tracks designed to regulate mood. In the IMT arm, an AI generation pipeline creates bespoke instrumental tracks based on weekly participant preferences regarding tempo, instrumentation, and emotional valence. To equalize participant-researcher contact across arms and reduce attention and expectation bias, participants in the nonindividualized arm complete a weekly music-experience questionnaire matched in length and timing to the IMT arm's weekly preference assessment, and treatment credibility and outcome expectancy are measured at baseline in both arms. The primary outcomes are the response rate at 8 weeks (defined as ≥50% reduction in Montgomery-Åsberg Depression Rating Scale [MADRS], Hamilton Anxiety Rating Scale [HAMA], or Pittsburgh Sleep Quality Index [PSQI] scores) and changes in quantitative electroencephalography characteristics. Secondary outcomes include changes in MADRS, HAMA, and PSQI scores from baseline to 8 weeks. Ethical approval was obtained from the Ethics Review Committee of Peking Union Medical College Hospital (I-24PJ0689). Written informed consent will be obtained from all participants. The recruitment started on May 24, 2024, and the study is expected to be completed by December 2027. Results will be disseminated via peer-reviewed publications, conference presentations, and stakeholder communications. Authorship will follow the International Committee of Medical Journal Editors (ICMJE) criteria. The participant-level dataset will be available upon reasonable request. This protocol outlines a translational framework designed to address the "therapeutic ceiling" of traditional music therapy. By integrating generative AI with neurophysiological monitoring, this program aims to develop a scalable, precision-medicine approach to mental health care that is both clinically effective and biologically grounded.
Despite clinical advances, breast cancer screening adherence remains stagnant in Japan (<50%) compared with the United States (>70%). Understanding distinct cross-cultural barriers is essential; however, traditional methodologies often fail to capture visceral, real-world individual experiences and hidden deterrents to screening. This study aims to characterize and compare cross-cultural informatics profiles of barriers to breast cancer screening across Japanese-language and English-language social media discourse. We developed an automated natural language processing pipeline on a cloud-based informatics platform to analyze 46,823 screening-related posts (30,027 in Japanese and 16,796 in English) from X (formerly Twitter) collected in 2025, derived from an initial 76,955 posts after noise exclusion. The methodology integrated large language model-assisted sentiment polarity scoring with strict negation-handling, co-occurrence network topology analysis, and advanced distributional visualizations, including raincloud and ridgeline plots. Subgroup comparisons (prescreening vs postscreening and ultrasound with vs without mammography) were evaluated. Among the 46,823 screening-related posts, overall sentiment distributions showed no practically meaningful cross-cultural divergence (Cohen d=0.049); however, domain-specific analyses revealed sharp disparities in barrier prevalence. Within the English-language cohort containing 16,796 posts, discourse exhibited a concentrated, moderate negative sentiment regarding systemic barriers, featuring "Cost" as the primary barrier (n=1239, 7.4%), while "Pain" ranked considerably lower (n=842, 5.0%). In contrast, the Japanese-language cohort containing 30,027 posts was heavily bottlenecked by psychosomatic barriers, governed by a tightly interconnected network of "Pain," "Fear," and "Appointment." "Pain" emerged as the overwhelmingly dominant barrier (n=5788, 19.3%). In the English-language cohort, "Dense" breasts emerged as a prominent clinical topic due to elevated public awareness, distinct from the financial narrative. The Japanese subgroup analyses identified a temporal transition from anticipatory psychological anxiety ("Fear," 739/3805, 19.4%) and logistical concerns ("Appointment," 1556/3805, 40.9%) before screening to a strong persistence of the discomfort memory of "Pain" (1160/7419, 15.6%). Furthermore, sentiment scores for mammography were significantly more negative than those for ultrasound alone (P<.001, Cohen d=0.264), and pain-related descriptors for ultrasound spiked from 5.0% (106/2110, ultrasound alone) to 18.2% (733/4017) when performed concurrently with mammography. Despite comparable overall emotional equilibrium, a fundamental dichotomy emerged. The English-language discourse predominantly reflects US-specific systemic financial burdens, whereas the Japanese experience is characterized by emotional volatility transitioning from anticipatory anxiety to a tightly interconnected "Pain-Fear-Appointment" network. Physical discomfort of mammography dominates the screening narrative, overshadowing concurrent painless modalities like ultrasound. Improving adherence in Japan requires individualized pain-mitigating compression protocols and optimized clinical workflows to decouple mammographic discomfort from supplemental screening, thereby preventing pain-associated defensive avoidance and reducing logistical hurdles to improve equitable access.
AI is rapidly transforming health systems, expanding from diagnostic imaging and predictive analytics to large language model-enabled clinical decision support. However, significant governance challenges persist, including algorithmic bias, privacy risks, limited transparency, and inequities in access. Despite the proliferation of national AI strategies, global governance remains fragmented, and systematic evidence on how national policies address ethical, regulatory, and implementation requirements is limited. No comprehensive synthesis currently maps national governance approaches against established frameworks or documents or accounts for implementation realities across diverse contexts. This scoping review aims to (1) characterize national approaches to AI governance in health, (2) assess alignment with established governance frameworks, and (3) identify implementation challenges and enabling factors. Following the Arksey and O'Malley framework and PRISMA-ScR (Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews) guidelines, we searched 6 databases and key gray literature repositories for sources published between January 2015 and April 2025. Eligible documents include national-level policies, empirical analyses, and official reports on AI governance in health. Data extraction is guided by a framework integrating World Health Organization AI ethics and governance guidance and the strategic priorities of the Global Initiative on AI for Health across 4 dimensions-ethics, regulation, implementation, and operations. Descriptive mapping, governance principle coding, thematic synthesis, and subgroup analyses will be conducted. Our systematic search across 6 electronic databases identified 21,278 records: 3409 (16.0%) from PubMed, 5691 (26.7%) from Embase, 3661 (17.2%) from Web of Science, 334 (1.6%) from Latin American and Caribbean Health Sciences Literature, 568 (2.7%) from the China National Knowledge Infrastructure, and 7615 (35.8%) from the WanFang Database. After removing 968 (4.6%) duplicates in EndNote (version V.21; Clarivate), 2 researchers independently screened 20,310 (95.5%) titles and abstracts. From 21,278 database records and 972 gray literature items, 149 (0.7%) sources met the inclusion criteria. Quality assessment and full data extraction will be finalized by June 2026. This review protocol addresses a critical evidence gap by providing a comprehensive mapping of national AI governance policies in health against an established governance framework. The planned review will inform evidence-based, equitable, and context-specific governance frameworks essential for safe and trustworthy AI integration in health systems.
Cardiovascular disease remains the leading global cause of mortality, driven by interrelated behavioral, biological, and psychosocial risk factors, despite the availability of effective prevention and treatment strategies. Persistent policy inertia, systemic fragmentation, and adverse social and commercial determinants have limited national responses. Addressing these gaps necessitates place-based, systems-oriented approaches that mobilize local assets, engage multisector stakeholders, and incorporate adaptive evaluation. The Springfield Healthy Hearts initiative exemplifies such an approach by positioning Greater Springfield as a "living laboratory" for coordinated cardiovascular health action through a comprehensive data framework, providing a replicable model for other communities. This protocol outlines the Springfield Healthy Hearts Data Framework, a multicomponent system for dynamically guiding, implementing, and evaluating coordinated action for heart health. The data framework was developed through a structured co-design process involving community members, expert researchers, health professionals, and representatives from local implementation partners. The framework comprises four integrated components: (1) Project evaluation, applying pragmatic frameworks to assess coordinated action projects; (2) Community evaluation, a repeated cross-sectional evaluation of Springfield residents, workers, and regular visitors to capture individual-level behavioral, biological, and psychosocial cardiovascular disease risk factors, as well as engagement with coordinated action projects; (3) City evaluation, ongoing monitoring of suburb- and city-level indicators across 4 domains (sociodemographic characteristics, built environment, food and commercial environment, and health services); and (4) Data synthesis, to utilize data across all levels to inform a continuous learning system. Project evaluations will use both quantitative and qualitative methods, including realist evaluation where appropriate. Community evaluation will be analyzed using descriptive statistics, mixed effects models, and subgroup analyses, with missing data addressed via multiple imputation. City-level data will be analyzed descriptively and dynamically to detect temporal trends and contextual changes. Initial funding for the Springfield Healthy Hearts Data Framework was secured in June 2025. Co-design workshops were conducted between November 2025 and February 2026 (n=15 participants), informing the design and prioritization of framework components. Community evaluation data collection is scheduled to commence in September 2026 and conclude in August 2027. Data cleaning and preliminary analyses are anticipated in late 2027, with first results expected to be disseminated in early 2028. The Springfield Healthy Hearts Data Framework is a replicable model for other communities aiming to implement city-wide, coordinated approaches to heart health action. Findings will be disseminated through peer-reviewed publications, community reports, interactive dashboards, and policy briefs.
High-risk subsolid pulmonary nodules, especially mixed ground-glass nodules, can represent precancerous or early-stage lung adenocarcinoma spectrum lesions. Standard management relies mainly on risk stratification, repeated thin-slice computed tomography, and invasive diagnosis or surgery when progression suggests malignancy. Safe adjunctive pharmacologic options to reduce nodule progression remain limited. Yifei Sanjie Pill (YFSJ) is an 8-herb traditional Chinese medicine formula that has been previously studied as an adjunctive treatment for non-small cell lung cancer. However, its effect on high-risk pulmonary nodules-a distinct clinical condition-has not yet been investigated. This protocol describes a multicenter randomized trial evaluating the efficacy, safety, and exploratory mechanisms of YFSJ for preventing high-risk pulmonary nodule progression. Adults aged 18 to 80 years with single or multiple mixed ground-glass nodules measuring ≤8 mm will be randomized in a 1:1 ratio to receive YFSJ optimized formula granules or matched placebo granules, 2 packets twice daily for 6 months. Both groups will receive guideline-based computed tomography surveillance and any clinically indicated standard diagnostic or therapeutic care. The primary outcome is the 2-year pulmonary nodule progression rate, defined as an increase in the lesion's longest diameter of ≥2 mm, an increase in the solid component of ≥1 mm, or the appearance of a new solid component. Secondary outcomes include lung cancer detection rate, surgery rate, 6-month nodule size and volume change, artificial intelligence-based malignancy risk index, traditional Chinese medicine symptom score, Hospital Anxiety and Depression Scale (HADS) score, Pittsburgh Sleep Quality Index (PSQI) score, safety indicators, and exploratory plasma biomarkers. The primary analysis will use the full analysis set, Kaplan-Meier estimates, log-rank testing, and Cox regression adjusted for center and key covariates; repeated outcomes will be analyzed using mixed-effects models. The study was funded in 2022 and approved by the Research Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine (K-2022-131-XZ-01). Recruitment started in June 2023 and was scheduled for completion in December 2025. As of April 2026, a total of 589 participants have completed randomization. The final 2-year follow-up is scheduled for December 2027. Database lock and primary analysis are planned for early 2028, and submission of the first results is expected in spring or summer 2028. This trial will determine whether adding YFSJ to guideline-based surveillance can reduce high-risk pulmonary nodule progression and provide mechanistic evidence for integrative early lung cancer prevention.
An ecological momentary assessment (EMA) is a methodological framework designed to capture real-time data in a participant's natural environment, yet its feasibility in older adults, particularly in a large, multisite study, remains underexplored. This study aims to assess the feasibility of implementing automated daily phone surveys in a large, geographically diverse cohort of older adults. A total of 1283 participants from the Multi-Ethnic Study of Atherosclerosis (MESA) were enrolled across 6 US field sites. Participants were scheduled to receive 1 automated phone survey per day for 7 consecutive days following a clinic visit. Feasibility was assessed through a dual lens of participant engagement (survey adherence, phone survey duration, and cancellations) and administrative implementation (scheduling errors). Of the 1272 participants who received at least 1 of the 7 phone surveys, high adherence was observed, with 81.84% (1041/1272) completing 5 to 7 surveys. Age was the only demographic characteristic significantly associated with completion (P=.002), as younger participants demonstrated higher adherence. While the median survey duration was 3 (IQR 2-4) minutes, 26.84% (2371/8835) of surveys lasted 5 minutes or longer. However, adherence remained remarkably robust even among participants experiencing these extended durations. Participant-initiated cancellations during the 7-day monitoring period were rare, occurring among 21 of 1272 (1.65%) participants who began monitoring. Administrative scheduling errors were also uncommon, accounting for 37 of the 8835 (0.42%) total scheduled surveys not being delivered. Findings support the feasibility of automated daily phone surveys for collecting repeated real-world data in large, multisite studies of older adults. Future studies should incorporate standardized participant feedback to identify barriers to engagement and support more inclusive, participant-centered adaptations of automated phone-based EMA protocols.
Community and youth violence are pervasive and have devastating health, economic, and social consequences. Violence too often impacts people of color and the life trajectories of youth in the United States, especially among people living in urban settings. In response, this study aims to evaluate the effectiveness of a novel Community Resiliency Collective Efficacy Intervention (CRCEI), which seeks to increase individual and neighborhood levels of collective efficacy, and reduce youth and community violence. The CRCEI has three phases: (1) community organizing and mobilization (engaging and working with diverse community members and collaborators to build capacity, plan, and recruit); (2) collective efficacy training (learning, discussing, and practicing relationship building, and facilitating thriving, resiliency, and strategies for organizing and intervening); and (3) community-based prevention projects (based on what participants learn in the training). The study was set in 8 urban, high-violence, racially segregated, and economically disadvantaged neighborhoods in Pittsburgh, Pennsylvania. Community partners and researchers selected 4 intervention sites based on perceived need and appropriateness. We then used participatory propensity score matching to select 4 comparison sites, which receive health education sessions in lieu of the CRCEI. The study assesses the impact of the CRCEI on participant-level collective efficacy and exposure to community violence (aim 1), community-level collective efficacy, and incidence of community violence (aim 2) via several data sources, including pre- and postsurveys with participants and community members, quantitative and qualitative data from observations and interviews, and secondary neighborhood-level data (eg, violence incidents and poverty rate). Data for aim 1 were collected from February 2023 to January 2025, and data for aim 2 were collected from September 2022 to May 2025. We complemented this impact analysis with an ethnographic process evaluation, which tracks fidelity and costs, describes implementation, and identifies facilitators and barriers across the intervention sites (aim 3). We hypothesize that the CRCEI will provide a concrete, action-focused strategy to increase resiliency and reduce community and youth violence, with impact demonstrated by increased reports of collective efficacy and decreased exposure to violence at the individual (aim 1) and community levels (aim 2). Innovations of this project include testing a community-oriented and collective efficacy-oriented violence reduction intervention (vs criminal-legal and punishment-oriented strategies), implementation in participatorily identified and asset-mapped local settings (eg, neighborhoods for inclusion and community partners to host the intervention identified by community members as trustworthy), a capacity-building approach (eg, training facilitators from focal neighborhoods), and community member integration into collaborative team science. In this manuscript, we outline the rationale and design for the evaluation of this collective efficacy intervention.