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Artificial intelligence (AI) has the potential to transform health care; however, successful integration of AI into health care requires overcoming obstacles, such as biases in data and AI models, and addressing challenges in generating sufficient clinical evidence for deployment. In this Viewpoint, we present a community-based, actionable framework for responsible and ethical development, deployment, and integration of AI-based solutions in health care, emphasising bias mitigation and clinical evidence generation. Our framework is intended for all members of the health-care team who interact with AI-based solutions, including software developers, data scientists, researchers, clinicians, hospital administrators, and institutional ethics and regulatory teams. We critically discuss the challenges associated with the use of such AI frameworks in health care. The framework, informed by multidisciplinary expertise, consists of four stages: (1) problem identification and study design, (2) model training and development, (3) silent deployment and clinical evaluation, and (4) operational deployment and lifecycle monitoring. This framework aligns with reporting standards such as SPIRIT-AI, CONSORT-AI, and TRIPOD+AI, offering practical steps for addressing biases, ensuring fairness, and validating clinical effectiveness. The framework provides action-oriented guidelines that can be used by institutions to support the ethical and efficient integration of AI into health care and equitable patient outcomes, either directly or by tailoring the guidelines with institution-specific resources.
TPS5129 Background: Management of patients (pts) with mCSPC remains a challenge due to its incurable nature and heterogeneous response to androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI). Recent analyses of phase III ADT + ARPI trials show that mCSPC with suboptimal PSA response (≥0.2ng/ml at 6-12 months) have poor prognosis, short time to castration-resistance (CRPC) and 30-36 month median overall survival (OS). While docetaxel could also be utilized in mCSPC, there is equipoise about its use in ARPI-treated pts because of 1) an absence of randomized data for docetaxel in this setting, 2) toxicity of docetaxel with impact on quality of life for pts, and 3) selection of docetaxel treatment by disease volume rather than disease biology. CCTG-PR26 (TRIPLE-SWITCH) is a joint CCTG-SWOG trial run through the NCI National Clinical Trials Network. This study investigates whether adding docetaxel prior to development of CRPC, regardless of disease volume, will improve OS in ARPI-treated mCSPC pts that show evidence of suboptimal response. Methods: This international, open-label, randomized phase III trial compares standard ADT + ARPI against the addition of docetaxel to ADT + ARPI in mCSPC pts with suboptimal PSA response, defined as PSA ≥0.2 ng/mL after 6-12 months of ADT and ≥4 months of ARPI. Stratification will be based on PSA levels, ARPI type, presence of liver metastasis, disease recurrence status, and time since ADT initiation. Arm 1 will continue standard ADT + ARPI (abiraterone acetate with prednisone, apalutamide, enzalutamide or darolutamide). Arm 2 will receive docetaxel 75mg/m 2 IV every 3 weeks for up to 6 cycles in addition to continuing standard ADT + ARPI. Sample size is 830 pts in order to detect a targeted 33% improvement in overall survival (hazard ratio 0.75) using a 1-sided 0.025 level test with 85% power. Key eligibility criteria are: ≥18 years, histologically confirmed prostate adenocarcinoma, metastatic disease present and confirmed by conventional imaging (CT and/or bone scan), PSA ≥5.0 ng/mL prior to ADT, receipt of ADT for 6-12 months and ARPI for ≥4 months, PSA ≥0.2 ng/mL within 14 days of enrolment, adequate organ and marrow function, ECOG performance status 0-2, eligible for docetaxel chemotherapy, no evidence of disease progression or biochemical progression on ADT prior to enrolment. Primary endpoint is overall survival. Secondary endpoints include PSA response, PSA kinetics, and clinical progression free-survival. Correlative studies will explore the prognostic and predictive value of circulating tumor DNA (ctDNA) and the association between molecular signatures in primary prostate cancer tissue and clinical outcomes. Enrolment has been initiated in January 2025 and is ongoing. Clinical trial information: NCT06592924 .
Hypermetabolism is a well-recognized component of the detrimental systemic response following severe burn injury. Despite extensive clinical observations and research output, the underlying mechanisms that drive this persistent metabolic dysregulation remain poorly understood. One emerging area of interest is the role of extracellular vesicles (EVs), small membrane-bound particles released by cells that are increasingly recognized as important mediators of intercellular communication and contributors to various pathological conditions. Recent studies have highlighted their significant involvement in metabolic regulation, acting as carriers of bioactive molecules that influence metabolic pathways in recipient cells. EVs contribute to the modulation of glucose and lipid metabolism, insulin sensitivity, mitochondrial function, and inflammation, thereby influencing systemic metabolic homeostasis. In this context, EVs have been proposed as potential mediators in the metabolic problems that follow severe burn injuries. Burn-induced hypermetabolism, marked by insulin resistance, muscle wasting, and systemic inflammation, is affected by exosome-driven signaling between damaged tissues and metabolic organs. Exosomes released after a burn carry inflammatory cytokines, stress-response proteins, and metabolic regulators that change cellular functions in distant organs such as the liver, skeletal muscle, and adipose tissue. Understanding how exosomal communication contributes to post-burn metabolic issues could lead to new diagnostic and treatment options for improving recovery and metabolic health in burn patients. This review aims to clarify the role of EVs in burn-induced metabolic problems, emphasizing their potential as new mediators in the complex systemic response, which may provide new insights into the underlying mechanisms and help identify novel therapeutic targets.
BACKGROUND:Clinical trial participants have a right to know the results of the trials in which they participate. Trial results are often not shared directly with participants and concerns with privacy and resource constraints may prevent researchers from contacting participants after trial completion. QUESTIONS/PURPOSES:The objectives of this cross-sectional study were to explore the feasibility of contacting orthopaedic fracture trial participants after trial completion and to determine the preferences and priorities of the participants who wished to know the results. PATIENTS/METHODS:Following the publication of the primary manuscript, we attempted to contact participants from the completed PREPARE trial at Hamilton Health Sciences to determine if they would like to know the trial results. We asked participants about their preferences for receiving trial results, their experiences upon learning them, and if they wished to learn which treatment they received. RESULTS:Twenty-eight percent (181/641) of PREPARE trial participants contacted agreed to participate in this study. We found that 95.5% (95% CI 91.0%-97.9%) of respondents wished to know the trial results and the preferred method was through viewing summary posters via an online link (78.2%; 95% CI 71.1%-84.0%). Most felt satisfied after learning the trial results (67.8%; 95% CI 59.5%- 75.2%) and 82.2% (95% CI 75.2%-87.5%) wanted to know which treatment they received. Fifty-one percent (95% CI 42.7%-58.7%) reported that learning the results increased their likelihood of participating in a future trial. CONCLUSIONS:Although it was challenging to both contact and re-engage participants after completing an orthopaedic trial that involved minimal participant burden, our study findings suggest that learning the trial results may have a positive impact on individual participants and the research community. Given the limited understanding of results among our respondents, researchers should have processes in place to engage participants meaningfully throughout the trial and proactively discuss with them how the results will be shared once the trial is complete. LEVEL OF EVIDENCE:IV.
Compassion is a key characteristic of quality healthcare, widely studied in in-person settings among diverse populations. However, how compassion in virtual care is conceptualized and experienced by migrants and refugees, as well as by the healthcare providers delivering care to these populations, remains unclear. This scoping review aimed to (1) synthesize peer-reviewed literature examining how compassionate virtual care is conceptualized and experienced by migrants and refugees, as well as by healthcare providers delivering virtual care to these populations, and (2) identify the facilitators and barriers influencing access to, uptake of, and the delivery of compassionate virtual care. A systematic search of MEDLINE, PsycINFO, and Scopus from 2010 to 2024 identified studies focused on migrant and refugee populations or their healthcare providers, digital health modalities, and compassionate care or related traits. Following title and abstract screening, two reviewers conducted full-text review and extracted data, which were synthesized using a narrative and thematic approach. Of 2,630 records, 38 studies met inclusion criteria. Compassionate virtual care was described through traits such as trust, comfort, safety, and emotional support. It was conceptualized as both an outcome of addressing equity-related barriers in healthcare and a process of receiving quality care. Migrants and refugees perceived virtual care as compassionate when providers accommodated their individualized needs, offered culturally safe practices, and created linguistically accessible environments. Structural and sociotechnical barriers, such as limited technology access and digital literacy, prohibited compassionate care. This review underscores the need for culturally sensitive and linguistically accessible virtual care models that are responsive to the intersecting identities of end users and highlights the need for research into structural and institutional factors that can support compassionate care in digitally enabled health systems. These findings can inform equitable and inclusive healthcare delivery for migrants and refugees.
