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Reporting checklist for foundation and large language models in medical research (REFINE): an international consensus guideline

Mese, Ismail; Akinci D'Antonoli, Tugba; Bluethgen, Christian; Bressem, Keno; Cuocolo, Renato; Chaudhari, Akshay; Tejani, Ali S; Isaac, Amanda; Ponsiglione, Andrea; Meddeb, Aymen; Khosravi, Bardia; Le Guellec, Bastien; Kahn, Charles E; Suh, Chong Hyun; Pinto Dos Santos, Daniel; Koh, Dow-Mu; Tzanis, Eleftherios; Kotter, Elmar; Colak, Errol; Kitamura, Felipe; Busch, Felix; Nensa, Felix; Yang, Guang; Müller, Henning; Kather, Jakob Nikolas; Nawabi, Jawed; Kleesiek, Jens; Zhong, Jingyu; Santinha, João; Haubold, Johannes; de Almeida, José Guilherme; Lekadir, Karim; Marias, Kostas; Reiner, Lara Noelle; Maier-Hein, Lena; Moy, Linda; Adams, Lisa C; Martí-Bonmatí, Luis; Paschali, Magdalini; Moassefi, Mana; Dietzel, Matthias; Huisman, Merel; Ingrisch, Michael; Klontzas, Michail E; Papanikolaou, Nikolaos; Diaz, Oliver; Kuriki, Paulo; Seeböck, Philipp; Rouzrokh, Pouria; Strotzer, Quirin D; Park, Seong Ho; Faghani, Shahriar; Tayebi Arasteh, Soroosh; Kim, Su Hwan; Venugopal, Vasantha Kumar; Kim, Woojin; Kocak, Burak
PURPOSE/OBJECTIVE:To develop the REporting checklist for FoundatIon and large laNguagE models (REFINE), an international reporting guideline for transparent and reproducible reporting of foundation model (FM) and large language model (LLM) studies in medical research, including imaging artificial intelligence (AI) applications. METHODS:The protocol was prespecified and publicly archived. A modified Delphi process was conducted to establish reporting standards for unimodal and multimodal FM and LLM applications involving text, imaging, and structured data. The steering committee coordinated protocol development, expert recruitment, all Delphi rounds, and the harmonization phase. Decisions were made based on predefined consensus thresholds. In Rounds 1 and 2, structured ratings and free-text feedback informed iterative revisions. In the post-Delphi harmonization phase, terminology was standardized, and detailed reporting instructions were finalized. RESULTS:The REFINE development group comprised 57 contributors from 17 countries, and 54 panelists from 16 countries completed Rounds 1 and 2. The harmonization phase was completed by three expert panelists and the steering committee. The entire process produced a 44-item, six-section framework with standardized terminology and detailed reporting instructions, supported by an online platform for practical use (https://refinechecklist.github.io/refine/checklist.html). CONCLUSION/CONCLUSIONS:The REFINE provides a comprehensive, consensus-based reporting standard for medical FM and LLM research, including imaging AI studies. The online version facilitates practical implementation. CLINICAL SIGNIFICANCE/CONCLUSIONS:The REFINE enables transparent, comparable, and reproducible reporting of FM and LLM studies, supporting reliable evidence synthesis in medical and imaging-focused AI studies.
PMID: 41742713
ISSN: 1305-3612
CID: 6010272

A highly sensitive issue: helping sensitized patients requires greater regulatory flexibility [Editorial]

Knechtle, Stuart J; Vincenti, Flavio G; Montgomery, Robert A
PMID: 41724436
ISSN: 1600-6143
CID: 6009522

Musculoskeletal Infection Reporting and Data System (MSKI-RADS): reviewed and explained

He, Angela; Duarte Silva, Flavio; Guirguis, Mina; Alaia, Erin F; Morrison, William B; Chhabra, Avneesh
A standardized guideline and scoring system are recommended for the imaging evaluation of musculoskeletal infections on MR imaging. The Musculoskeletal Infection Reporting and Data System (MSKI-RADS) is a recently developed and validated classification system using MR imaging that can be used to classify the severity and extent of musculoskeletal infections, improve radiology-pathology concordance, and outline the corresponding management recommendations. This review article explains MSKI-RADS and discusses the different elements of this system in detail with a review of pertinent literature so that the readers can apply it in their practices. The work outlines the technical considerations for optimal MR imaging for evaluating various musculoskeletal infectious lesions, details the severity scales with examples of various conditions that fall under each class, and outlines related patient management recommendations. The readers can learn about the MSKI-RADS classification system and apply the gained information from this article to improve MRI interpretations in their practice and increase the effectiveness of their multidisciplinary communications. This standardized system will also allow longitudinal data collection and tracking for future research purposes. CRITICAL RELEVANCE STATEMENT: MSKI-RADS is a recently developed and validated MRI-based guideline for musculoskeletal infections in extremities. A comprehensive understanding of these classifications can facilitate improved standardized diagnostic reporting of musculoskeletal infections on MRI and better patient outcomes. KEY POINTS: Current terminology for describing musculoskeletal infections on MRI is nonspecific, resulting in confusing diagnostic reports. A standardized guideline and scoring system are critical for improving diagnostic reporting of musculoskeletal infections on MRI. MSKI-RADS is a recently developed and validated MRI-based guideline that can be used to characterize musculoskeletal infections in extremities. MSKI-RADS is a meaningful tool that facilitates improvements in standardized reporting and treatment protocols, multidisciplinary communications, and longitudinal data collection.
PMCID:12932762
PMID: 41733733
ISSN: 1869-4101
CID: 6009842

Mapping Lung Stress to Visualize Spatial Heterogeneity and Occult VILI Risk in ARDS

Fox, Thomas H; Beitler, Jeremy R
PMID: 41738183
ISSN: 1535-4970
CID: 6010002

Systematic Review and Meta Analysis of Allergic Contact Dermatitis from 2-Octyl Cyanoacrylate Adhesives

Rouhani, Daniel S; Rosenbloom, Ashton; Zeng, Steven; Sun, Alexander; Seradj, Saba H; Moshrefi, Chloe; Khoo, Kimberly; Mofid, M Mark
BACKGROUND:2-octyl cyanoacrylate (2-OCA) topical skin adhesives are widely used for surgical wound closure but are increasingly associated with allergic contact dermatitis (ACD). We conducted a systematic review and meta-analysis to define the incidence, clinical features, and risk factors for 2-OCA-associated ACD. STUDY DESIGN/METHODS:A PRISMA systematic review of PubMed, Embase, and Web of Science (2008-2025) identified studies reporting cutaneous hypersensitivity to 2-OCA in human wound closure. Randomized, observational, and case-based reports were included. Risk of bias was assessed using ROBINS-I and RoB 2. Incidence from analytic cohorts was pooled using a random-effects model with prespecified subgroup analyses by surgical specialty. RESULTS:Seventy-four studies comprising 26,330 exposed patients were included; 20 analytic cohorts (25,442 patients) contributed to meta-analysis. The pooled ACD incidence was 4% (95% CI 3-5%) with substantial heterogeneity (I²=94.5%; prediction interval 0-12%). Incidence was 4% in orthopedic cohorts and 8% in plastic surgery cohorts, with lower rates in dermatology and obstetrics/gynecology (p=0.015 for subgroup differences). Re-exposure markedly increased risk, with reaction rates rising from 1-3% after initial exposure to >20% in staged or repeat procedures in several cohorts. Prior adhesive/contact allergy and cosmetic acrylate exposure were also strong risk factors. Diagnosis was primarily clinical, with selective patch testing. Management typically involved adhesive removal and topical corticosteroids; systemic therapy was reserved for severe cases. CONCLUSIONS:ACD to 2-OCA is a clinically meaningful and likely under-recognized complication of surgical wound closure. Re-exposure is strongly associated with increased postoperative reaction rates, supporting preoperative risk assessment and caution in repeat adhesive use.
PMID: 41784277
ISSN: 1879-1190
CID: 6008992

A Rapid Review of Qualitative Studies on the Latino Dementia Caregiving Experience

Estrada, Leah V; Rivera, Diego; McNulty, Carla M; Squeri, Barbara; Reckrey, Jennifer M
The Latino population is at an increased risk of developing dementia. Nurses have been identified as a main source of dementia care support for dementia caregivers. Latino dementia caregivers may have unique challenges due to factors including language barriers and cultural values and expectations. A rapid review was conducted to synthesize the qualitative literature on the experiences of Latino family caregivers of persons living with dementia to support nursing integration of palliative care for Latino family caregivers of persons living with dementia. Fifteen articles were included in this rapid review. Five emergent themes were identified from the included articles: (1) Culture and Caregiving Values; (2) Caregiving Challenges; (3) Health Care System Navigation; (4) Managing Dementia Care Without Formal Supports; and (5) Understanding of Dementia. Latino family caregivers often cited cultural values (eg, familismo) as central to their caregiving identities and balanced their own life and that of their loved one with limited support. This rapid review provides implications for practice, policy, and research that can better support the palliative care needs of Latino family caregivers of persons living with dementia and their caregivers.
PMID: 41778904
ISSN: 1539-0705
CID: 6008832

Scaling Impact With Healthcare Artificial Intelligence-Career Pivots, an AJR Podcast Series (Episode 8)

Dogra, Siddhant; MacLean, Ainsley
PMID: 41738732
ISSN: 1546-3141
CID: 6010052

Variation in the quality of opioid use disorder treatment in the Medicaid population in 2019

Andrews, Ryan M; Mhasawade, Vishwali; Maity, Selena; Hung, Anton; Liu, Richard; Ross, Rachael K; Samples, Hillary; Rudolph, Kara E
BACKGROUND:This study aimed to describe state- and urbanicity-stratified differences in three opioid use disorder (OUD) treatment metrics among Medicaid beneficiaries in 25 states that implemented Medicaid expansion under the Affordable Care Act by the end of 2014. METHODS:Using data from 2019, we identified Medicaid beneficiaries with OUD based on ICD-10 diagnosis codes. We then calculated the percentage of beneficiaries who met criteria for three metrics measuring OUD treatment quality, both overall and stratified by state and urbanicity type. The OUD treatment quality metrics considered were: (1) initiation of medication for opioid use disorder (MOUD) treatment, (2) engagement with OUD services, and (3) retention on MOUD treatment. RESULTS:Across states, we found that a median of 26.2% of beneficiaries initiated MOUD within 14 days of their OUD diagnosis date in the claims data. A median of 15.8% of beneficiaries engaged with OUD treatment services by initiating MOUD treatment within 14 days of their OUD diagnosis and receiving at least 2 distinct OUD-related services within 30 days of their MOUD initiation date. Among initiators, a median of 30.8% were retained on MOUD treatment for a minimum of 180 days. However, there was considerable heterogeneity in these three metrics across states; New Hampshire and West Virginia were found to have the highest overall performance out of the states considered. With respect to urbanicity, we found that rural and suburban areas had higher percentages of beneficiaries who met our three treatment quality metrics compared to urban areas. CONCLUSIONS:We found notable geographic differences in opioid use disorder treatment quality in the U.S. Medicaid population.
PMCID:12959680
PMID: 41779690
ISSN: 1932-6203
CID: 6008862

Efficacy and safety of relacorilant for the treatment of patients with Cushing's syndrome (GRACE): a multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study

Pivonello, Rosario; Arnaldi, Giorgio; Auchus, Richard J; Badiu, Corin; Busch, Robert S; Cannavò, Salvatore; Dischinger, Ulrich; Dobri, Georgiana A; Donegan, Diane M; Elenkova, Atanaska; Fazeli, Pouneh K; Feelders, Richard A; Garcia-Centeno, Rogelio; Gilis-Januszewska, Aleksandra; Hamidi, Oksana; Hannoush, Zeina C; Kargi, Atil Y; Miller, Harold J; Ranetti, Aurelian-Emil; Recasens, Monica; Reincke, Martin; Rovner, Sergio; Salvatori, Roberto; Silverstein, Julie; Stigliano, Antonio; Terzolo, Massimo; Wang, Christina; Yuen, Kevin C J; Kesner-Hays, Amanda; Hand, Austin L; Tudor, Iulia Cristina; Araque, Katherine A; Moraitis, Andreas G; ,
BACKGROUND:Relacorilant is a selective glucocorticoid receptor modulator designed to reduce excess cortisol activity by competing with cortisol for glucocorticoid receptor binding, mitigating the clinical manifestations of endogenous hypercortisolism (Cushing's syndrome). The aim of this study was to assess the efficacy and safety of relacorilant in adults with endogenous hypercortisolism. METHODS:This multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study enrolled adults with endogenous hypercortisolism and hypertension, hyperglycaemia, or both and was conducted at 77 study centres across 11 countries. Key inclusion criteria included being aged 18-80 years with at least two clinical signs or symptoms of hypercortisolism. In the open-label phase, patients received oral, once-daily relacorilant (escalation from 100 mg up to 400 mg) for 22 weeks. Patients who met response criteria were randomly assigned (1:1) by the interactive web response system to continue relacorilant 400 mg (or highest tolerated dose) or placebo for 12 weeks in the randomised-withdrawal phase. Participants and investigators were masked to treatment assignment. The primary outcome was the proportion of patients who lost hypertension response during the randomised-withdrawal phase compared between relacorilant and placebo at week 12. As per protocol, this outcome was assessed in all participants who received at least one dose of study drug in the study period (intention-to-treat population). Missing randomised-withdrawal week 12 values were considered a loss of response. Safety was assessed in all enrolled patients who received at least one dose of study drug in that period. This study is registered with ClinicalTrials.gov, NCT03697109. FINDINGS/RESULTS:Between Oct 16, 2018, and April 15, 2024, 404 patients were screened, 152 were enrolled, and 95 completed the open-label relacorilant phase. 62 patients met response criteria and were randomly assigned to relacorilant (30 total participants [21 met hypertension response criteria]) or placebo (32 total participants [22 met hypertension response criteria]). In the 30 participants in the relacorilant group, the mean age was 46·6 years (SD 11·0), 22 (73%) were female, and eight (27%) were male. In the 32 participants in the placebo group, the mean age was 48·8 years (SD 14·4), 26 (81%) were female, and six (19%) were male. During the randomised-withdrawal phase, significantly more patients with baseline hypertension who were randomly assigned to placebo lost hypertension control compared with those who continued relacorilant (proportion difference 34%; odds ratio 0·17 [95% CI 0·04-0·77]; p=0·022). In the randomised-withdrawal phase safety population, the most common adverse events in the 30 participants given relacorilant and the 32 participants given placebo were back pain (5 [17%] vs 6 [19%]), acne (3 [10%] vs 0), arthralgia (3 [10%] vs 3 [9%]), bursitis (3 [10%] vs 0), headache (3 [10%] vs 4 [13%]), and insomnia (0 vs 4 [13%]). There were no cases of excessive glucocorticoid receptor antagonism, adrenal insufficiency, vaginal bleeding associated with endometrial hypertrophy, drug-induced hypokalaemia, or drug-induced QT interval prolongation. INTERPRETATION/CONCLUSIONS:Patients treated with relacorilant were more likely to maintain hypertension control compared with patients treated with placebo. The findings support consideration of relacorilant as a therapeutic option to reduce the harmful and debilitating effects of endogenous hypercortisolism. FUNDING/BACKGROUND:Corcept Therapeutics.
PMID: 41730814
ISSN: 2213-8595
CID: 6009752

Plasma p-tau217 and cognitive impairment: Evaluating biomarker equity across racial/ethnic groups in HABS-HD

Hayes, Cellas A; Najmi, Zara; Contreras, Joey Annette; Dharmapuri, Anhiti; Winston, Charisse N; ,
INTRODUCTION/BACKGROUND:Plasma phosphorylated tau 217 (p-tau217) is a leading blood-based biomarker of Alzheimer's disease. Its performance in underrepresented racial/ethnic groups remains insufficiently characterized. METHODS:We analyzed 2798 participants from the Health and Aging Brain Study-Health Disparities, including non-Hispanic White, non-Hispanic Black, and Hispanic adults. Multivariable logistic regression and receiver operating characteristic analyses assessed associations and discriminative accuracy between plasma p-tau217 and clinical cognitive impairment with racial/ethnic-specific thresholds. RESULTS:Across all groups, p-tau217 levels were higher in cognitively impaired than unimpaired participants. Elevated p-tau217 was associated with greater odds of cognitive impairment in all racial and ethnic groups. Discriminative accuracy was modest but significant (area under the curve 0.65-0.72), with highest performance in non-Hispanic Black and lowest in Hispanic participants. DISCUSSION/CONCLUSIONS:Plasma p-tau217 is robustly associated with cognitive impairment across diverse populations with varying thresholds, highlighting the need for population-specific calibration to support equitable biomarker implementation.
PMCID:12935564
PMID: 41767155
ISSN: 2352-8729
CID: 6008172