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Accelerating responsibly: From novelty to necessity in visual assistive technology [Editorial]

Kempapidis, Theofilos; Manduchi, Roberto; Rizzo, John-Ross
PMID: 42334271
ISSN: 1949-3614
CID: 6055542

Surgical Outcomes from Nationwide Implementation of the International Best-Practice for Locally Advanced Pancreatic Cancer (PREOPANC-4) study

Stoop, Thomas F; Seelen, Leonard W F; van 't Land, Freek R; Scheepens, Jacobien C M; Ali, Mahsoem; van der Hout, Anna C; van der Kolk, B Marion; Bonsing, Bert A; Lips, Daan J; Manusama, Eric R; Willemsen, François E J A; Daams, Freek; Kazemier, Geert; Patijn, Gijs A; de Hingh, Ignace H; Wijsman, Jan H; Schreinemakers, Jennifer; Erdmann, Joris I; Mieog, J Sven D; Klaase, Joost M; Rietjens, Judith A C; Bosscha, Koop; Beuk, Lysanne P M; Nijkamp, Maarten W; den Dulk, Marcel; Kop, Marnix P M; Liem, Mike S L; Luyer, Misha; Stommel, Martijn W J; Busch, Olivier R; Festen, Sebastiaan; Bouwense, Stefan; Karsten, Tom M; van Ravens, Tom W; Neumann, Ulff P; de Meijer, Vincent E; Nieuwenhuijs, Vincent B; Draaisma, Werner A; Derksen, Wouter; Bollen, Thomas L; Groot Koerkamp, Bas; van Eijck, Casper H J; Quintus Molenaar, I; Wolfgang, Christopher L; Del Chiaro, Marco; Katz, Matthew H G; Hackert, Thilo; Wilmink, Johanna W; van Santvoort, Hjalmar C; de Wilde, Roeland F; Besselink, Marc G; ,
BACKGROUND:In expert centers, surgical resection rates of locally advanced pancreatic cancer (LAPC) following induction chemotherapy have increased beyond 20% with subsequent 25% five-year overall survival (OS). In the Netherlands, however, the historical low 8% LAPC resection rate compared with 23% in international expert centers reflects relative reluctance. Thereby, opportunities to achieve long-term survival in appropriately selected patients may be missed. This study evaluated whether nationwide implementation of international multidisciplinary best-practice for LAPC management is feasible while maintaining surgical safety benchmarks (in-hospital/30-day major morbidity <50% and mortality ≤5%). METHODS:A multidisciplinary protocol was designed in collaboration with four international experts and prospectively implemented nationwide within the Dutch Pancreatic Cancer Group (DPCG) (2022-2024). This observational cohort included consecutive patients diagnosed with LAPC, defined by DPCG criteria. Eligible patients had radiologically non-progressive disease after at least four months of multi-agent chemotherapy. All patients who underwent resection were included in this safety analysis. A predefined sub-group analysis included patients with National Comprehensive Cancer Network (NCCN) LAPC. Primary outcomes included in-hospital/30-day major morbidity (i.e., Clavien-Dindo grade ≥IIIa) and mortality. The expected number of resections was 53. RESULTS:Overall, 180 patients with LAPC underwent surgical exploration, of whom 155 (86%) underwent resection in 11 centers. Most (74%) resections were performed in the three LAPC surgical centers. Extended resections were performed in 77% of patients, including portomesenteric venous (60%), multivisceral (23%), and arterial (21%) resections. In-hospital/30-day major morbidity rate was 44% and mortality rate was 0.6%, both within pre-established safety benchmarks. Benchmarks were also reached for patients with NCCN LAPC (49% major morbidity, 2% mortality). CONCLUSION/CONCLUSIONS:Nationwide implementation of the international best-practice for LAPC was feasible with nearly three times more resections performed than expected, while morbidity and mortality remained well within predefined safety benchmarks.
PMID: 42329186
ISSN: 1365-2168
CID: 6055262

Alignment of Policy, Practice, and Patient Safety for Trustworthy AI in Radiology

Doo, Florence X; Davis, Melissa A; Poff, Jason; Lui, Yvonne W; Haines, Kevin; Towbin, Alexander J
Artificial intelligence (AI) has progressed from technical research to routine clinical use, reaching an inflection point where technological capabilities may exceed current regulatory and oversight frameworks. These systems are becoming more complex, progressing from narrow, task-specific algorithms to foundation models and early agentic prototypes. This progression has redistributed risk, responsibility, and clinical judgment, requiring radiologists and health care leaders to understand how policy choices affect patient safety and clinical innovation advancement. This special report provides a roadmap for aligning policy with clinical practice through a practical, lifecycle-based framework centered on patient safety. Translational bialignment is a concept that pairs regulatory science requirements (what AI systems should deliver to clinicians and patients) with implementation science capabilities (what institutions should provide for safe deployment of AI). This framework addresses the full AI lifecycle, from data stewardship and model development to validation, deployment, and monitoring, and articulates shared responsibilities for vendors, institutions, and clinicians grounded in trustworthy AI principles. The analysis focuses on U.S. regulatory frameworks, particularly Food and Drug Administration policies governing medical AI, with relevant highlights from international approaches. Concrete opportunities for radiologists to engage in policy formation, participate in oversight, and collaborate with industry and policymakers are provided to help shape a trustworthy and sustainable AI ecosystem. The alignment of policy, practice, and patient safety will enable medical AI to have a lasting impact on clinical care and public trust. The analysis and recommendations provided represent the authors' perspectives and do not necessarily reflect the official positions of the Radiological Society of North America. Keywords: Artificial Intelligence, Food and Drug Administration, Health Policy, Implementation Science, Large Language Models, Machine Learning, Patient Safety, Regulatory Science, Translational Bialignment © RSNA, 2026.
PMID: 42200797
ISSN: 2638-6100
CID: 6055052

Comparison of survival outcomes for people with HR+/HER2- metastatic breast cancer who received palbociclib, ribociclib, or abemaciclib with an aromatase inhibitor: a plain language summary

Rugo, Hope S; Layman, Rachel M; Lynce, Filipa; Liu, Xianchen; Li, Benjamin; McRoy, Lynn; Cohen, Aaron B; Estevez, Melissa; Curigliano, Giuseppe; Brufsky, Adam
PMID: 42324670
ISSN: 1744-8301
CID: 6055142

AI-assisted thematic synthesis of existing neurological core outcome sets: A descriptive reference framework (COS-Neuro)

Tiong, Shyun Ping; Yang, Xiaoyu; Touzet, Alvaro Yanez; Millward, Christopher Paul; Zipser, Carl M; Tetreault, Lindsay; Gharooni, Ali; Davies, Benjamin M
BACKGROUND:Neurological disorders affect approximately 3 billion people globally, yet clinical trial success is often hindered by poorly selected outcome measures, impacting trial design, compliance, and interpretation. Over the past 25 years, Core Outcome Sets (COS) have emerged as standardized tools to enhance outcome selection, ensuring comparability across studies and reflecting the priorities of both researchers and patients. Despite the success of COS initiatives in other fields, their development in neurology remains limited, leaving many trialists without disease-specific guidance. OBJECTIVES/OBJECTIVE:This study aimed to conduct an AI-assisted thematic synthesis of outcome domains from existing COS, with the goal of identifying structural patterns common to these sets and generating descriptive reference framework to inform future COS development. METHODS:COS-Neuro was developed using AI-assisted thematic framework analysis, complemented by expert review. A modified five-step thematic analysis was conducted without pre-determined codes: 1. Dataset Gathering - Data was collected from the COMET database, and COS domains for neurological disorders were coded. 2. Prompt Design & Testing - Large language models (LLMs), including ChatGPT 3.5, Google Gemini 1.5 Flash and Meta Llama-2-70b, were trialled, and prompts refined based on their outputs. 3. Thematic Analysis - LLMs categorised domains into core areas. 4. Human Refinement - Experts reviewed LLM-generated core areas and selected those most appropriate for further interpretation. 5. Clinical Validation - Experts validated the domains, core areas, and concepts. This approach integrated AI with expert oversight to develop an AI-descriptive thematic map of existing neurological COS. RESULTS:Utilising LLMs, particularly ChatGPT, an AI-assisted conceptual framework synthesising existing neurological COS was developed based on the analysis of 112 published COS. Through adaptation of the OMERACT model, the final framework comprised four overarching concepts, 13 core areas, and 75 domains identified through expert consensus. CONCLUSION/CONCLUSIONS:COS-Neuro provides a preliminary AI-assisted descriptive synthesis of existing neurological COS, organised using the OMERACT Filter 2.1 as a structural reference. This hypothesis-generating framework may serve as a foundational resource for future COS research and trial design, particularly in areas where no disease-specific COS exists. However, it requires prospective validation through disease-specific, multi-stakeholder consensus processes before clinical application. COS-Neuro also demonstrates the feasibility of AI-assisted thematic synthesis in this context and warrants evaluation in other specialties.
PMCID:13286209
PMID: 42329895
ISSN: 1932-6203
CID: 6055302

ADHD medication discontinuation and non-adherence: a Norwegian population-based register study

Garcia-Argibay, Miguel; Hofstad, Tore; Bjelland, Ingvar; Cortese, Samuele; Mykletun, Arnstein
BACKGROUND:Poor persistence and adherence to attention-deficit/hyperactivity disorder (ADHD) medication is a significant barrier to effective long-term care, particularly during adolescence, yet age-specific and sex-specific trajectories remain poorly characterised. OBJECTIVE:To characterise medication initiation, discontinuation and long-term adherence patterns for children and adolescents diagnosed with ADHD in a real-world setting. METHODS:A nationwide retrospective cohort study, including 8961 children and adolescents (aged <18 years) with a new ADHD diagnosis in child and adolescent mental health services between 1 January 2010 and 31 December 2012, with follow-up until 31 December 2021. Main outcomes were medication initiation rates; time to first medication discontinuation, analysed using Kaplan-Meier estimates and restricted mean survival time at 1 year and longitudinal adherence, measured by the proportion of days covered over 9 years. FINDINGS/RESULTS:Of the 8961 individuals in the cohort (mean age at diagnosis, 12 years; 69% male), 6661 (74.3%) initiated medication, with a median time from diagnosis to initiation of 106 days (IQR 17-231); 55% initiated within 90 days. Discontinuation increased significantly with age; adolescents aged 15-17 years remained on treatment for 31.9 fewer days (95% CI -40.8 to -23.1; p<0.001) in the first year compared with children aged 5-11 years. Females also discontinued significantly earlier than males (difference -13.2 days; 95% CI -19.8 to -6.5; p<0.001). Longitudinal analysis confirmed that older age at initiation and female sex were associated with a significantly steeper decline in medication coverage over time. CONCLUSIONS:Discontinuation and low adherence to ADHD medication were common and increased substantially through adolescence, with females at higher risk of early cessation. CLINICAL IMPLICATIONS/CONCLUSIONS:Late adolescence warrants closer clinical monitoring and shared decision-making to support appropriate treatment continuation or well-informed discontinuation, particularly for older adolescents and females. Integrating structured transition planning and attention to sex-specific barriers may help reduce avoidable non-adherence during this high-risk period.
PMCID:13289004
PMID: 42331561
ISSN: 2755-9734
CID: 6055402

Palliative Care Coaching for Family Caregivers of Patients With Advanced Cancer: A Randomized Clinical Trial

Odom, J Nicholas; Azuero, Andres; Taylor, Richard A; Young Pierce, Jennifer; McGowen, Chelsea L; Pisu, Maria; Rocque, Gabrielle; Reed, Rhiannon D; Wells, Rachel; Gazaway, Shena; Mollman, Sarah; Williams, Grant R; Huang, Chao-Hui Sylvia; Engler, Sally; Bakitas, Marie A
IMPORTANCE/UNASSIGNED:African American and rural-dwelling family caregivers of persons with newly diagnosed advanced cancer perform critical, time-intensive tasks and historically have had limited resources to support their role. OBJECTIVE/UNASSIGNED:To determine the effect of a lay coach-led, early palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends [ENABLE] Cornerstone) for African American and rural-dwelling family caregivers of patients with advanced cancer on caregiver and patient outcomes at 24 weeks. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This single-blind randomized clinical trial was conducted from January 2020 to May 2025 at outpatient oncology clinics at 2 large cancer centers in the Southeastern US. Participants were African American and rural-dwelling family caregivers aged 21 years or older self-identifying as an unpaid close friend or family member who is involved with the day-to-day medical care of a patient with advanced cancer. INTERVENTION/UNASSIGNED:The intervention included 6 weekly, 20- to 60-minute psychosocial telephonic sessions facilitated by a trained lay coach plus monthly follow-up. Usual care consisted of mailed pamphlets outlining resources for families at each of the cancer centers. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was caregiver distress (anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale [HADS]) at 24 weeks. Secondary outcomes were caregiver and patient quality of life (QOL; measured with the Patient-Reported Outcomes Measurement Information System Global Health Short Form), caregiver burden (Montgomery-Borgatta Caregiver Burden Scale), and patient distress (HADS). Outcomes were assessed using baseline-constrained linear mixed-effects models. RESULTS/UNASSIGNED:A total of 222 family caregivers (mean [SD] age, 55.5 [14.7] years; 169 [76.1%] female; 114 [51.4%] African American; 101 White [45.5%]; 7 other race [3.2%]) and 165 patients (mean [SD] age, 60.7 [12.2] years; 98 [59.4%] female; 79 African American [47.9%]; 84 White [50.9%]; 2 other race [1.2%]) were randomized. At week 24, no relevant between-group differences were observed in caregiver HADS anxiety (mean [SE] baseline-adjusted difference, 0.23 [0.44]; Cohen d = 0.05; 95% CI, -0.14 to 0.24; P = .60) or HADS depressive symptom scores (mean [SE] baseline-adjusted difference, 0.04 [0.41]; Cohen d = 0.01; 95% CI, -0.19 to 0.21; P = .91). For all other outcomes, 24-week differences were of small magnitude and not statistically significant. Exploratory sensitivity analyses of caregivers distressed at baseline indicated improvements in caregiver anxiety (mean [SE] baseline-adjusted difference, -1.21 [0.53]; Cohen d = -0.38; 95% CI, -0.70 to -0.05) and patient mental health QOL (mean [SE] baseline-adjusted difference, 3.00 [1.37]; Cohen d = 0.45; 95% CI, 0.04 to 0.86), but no statistically significant differences in caregiver burden (mean [SE] baseline-adjusted difference, -1.15 [0.69]; Cohen d = -0.32; 95% CI, -0.71 to 0.06) and patient depression (mean [SE] baseline-adjusted difference, -1.30 [0.71]; Cohen d = -0.37; 95% CI, -0.77 to 0.03). CONCLUSIONS/UNASSIGNED:This randomized clinical trial of a telehealth intervention for African American and rural-dwelling caregivers of patients with advanced cancer found no differences in caregiver and patient outcomes at 24 weeks. However, an exploratory sensitivity analysis indicated potential improvements in caregiver anxiety and patient mental health QOL. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04318886.
PMCID:13291851
PMID: 42334850
ISSN: 2574-3805
CID: 6055562

Research priorities for advancing mental health in elite sport: a companion to the IOC consensus statement on mental health in elite athletes

Kroshus-Havril, Emily; Reardon, Claudia L; Gouttebarge, Vincent; Aron, Cindy Miller; Bahr, Roald; Blauwet, Cheri; Castaldelli-Maia, João Mauricio; Cheng, Camille; Currie, Alan; Derevensky, Jeffrey Lee; Edwards, Carla; Fussek, Sarah; Gorczynski, Paul; Grandner, Michael A; Han, Doug Hyun; Hitchcock, Mary E; Lu, Frank; Massey, Andrew; McDuff, David; Mountjoy, Margo; Purcell, Rosemary; Putukian, Margot; Rice, Simon M; Sloan, Scott; Soligard, Torbjørn; Sundgot-Borgen, Jorunn Kaiander; Swartz, Leslie; Thornton, Jane S; Tshube, Tshepang; Hainline, Brian
PMID: 42331600
ISSN: 1473-0480
CID: 6055412

Orthoplastic Surgery: A Practical Approach to Limb Salvage

Barrera, Janos; Levine, Jamie; Levin, L Scott; Hacquebord, Jacques
Complex extremity wounds, if not addressed properly, are a leading cause of major limb amputation. Chronic wounds in salvaged extremities contribute to long-term morbidity in the extremity. Orthoplastic surgery treats limb-threatening conditions through the combined application of orthopaedic and plastic surgical principles, applied to clinical problems simultaneously. Key components include early stakeholder evaluation of the limb and patient and open collaborative communication between orthopaedic and plastic surgeons. Meticulous débridement at the time of presentation and careful selection of fixation informed by the overall reconstructive plan should be executed when the patient presents to the emergency department. Implementation of Orthoplastic protocols results in quicker time to skeletal stabilization and soft tissue coverage, reduced risk of infection, improved functional outcomes, and less cost for care. This review presents a protocol-driven guide for establishing an Orthoplastic program and optimizing limb salvage outcomes across diverse practice settings.
PMID: 42335408
ISSN: 1940-5480
CID: 6055602

Comfort, benefit, and distress: An exploratory study of research experiences of bereaved parents in the neonatal intensive care unit

Lin, Matthew; Williams, David N; Vitcov, Giselle; Sayeed, Sadath; DeCourcey, Danielle D; Wolfe, Joanne; Cummings, Christy L
BACKGROUND:Understanding the research experiences of bereaved parents is necessary to advance palliative care. OBJECTIVE:To evaluate levels of and factors associated with bereaved parent comfort, benefit, and distress from research participation and to qualitatively explore research experiences. STUDY DESIGN/METHODS:Exploratory analysis of survey data from parents of infants who died in a level IV NICU (2010-2020). Fisher's exact and Chi-square tests were used to identify factors associated with parental comfort, distress, and benefit. Qualitative analyzed was performed using the constant comparative method. RESULTS:40/146 parents (27%) responded. 83% reported being "very comfortable" or "comfortable", 83% reported "some" to "a lot" of benefit, 26% reported "a great deal" to "a lot" of distress from participation. Goal-discordant care was significantly associated with distress. Research participation themes included "helping others", "processing experiences" and "re-living negative experiences". CONCLUSION/CONCLUSIONS:Bereaved NICU parents simultaneously experience distress, comfort, and benefit from research participation.
PMID: 42332048
ISSN: 1476-5543
CID: 6055452