Citations

Introduction Women residing in rural areas or belonging to lower socioeconomic status (SES) strata experience disproportionately low rates of breast cancer screening, contributing to delayed diagnoses and poorer prognoses. In addition, their participation in clinical trials remains markedly limited, reducing opportunities to access preventive and screening interventions. Promoting research preparedness among women before disease onset may empower them to make informed decisions regarding their health and willingness to participate in clinical research with fewer emotional and logistical barriers. Methods and analysis This project applies a community-based participatory research approach to develop and refine the WeCARE (Women’s Engagement for Cancer Awareness, Resources and Education) intervention for women aged 50–74 years who have either never undergone breast cancer screening or have not received screening in the past 5 years and who reside in rural areas or belong to low SES groups. The intervention consists of two components. Component 1 is a single-day, in-person community forum that includes (a) an educational seminar led by an oncologist to address breast cancer risk and screening guidelines, (b) survivor storytelling to enhance emotional engagement and cultural resonance and (c) facilitated navigation to breast cancer screening and future research participation. Component 2 involves structured post-forum follow-up through multiple touchpoints (phone calls and mailed boosters) to reinforce knowledge, address barriers and support screening completion and research enrolment. Quantitative data (eg, screening completion, satisfaction and follow-up engagement) will be summarised using descriptive statistics to assess feasibility and reach on 50 participants. Qualitative feedback from participants will undergo thematic analysis to identify barriers, facilitators and perceived cultural relevance. Integrated mixed-method interpretation will inform iterative refinement of the WeCARE intervention and guide design of subsequent larger trials. Ethics and dissemination Approved by the Mayo Clinic Institutional Review Board (IRB #25–008934). All participants will provide informed consent. Procedures ensure confidentiality, cultural sensitivity and participant safety. Data will be stored in REDCap and disseminated through publications, conferences, local town halls and community reports.

ABSTRACT Cancer mortality is inequitably distributed across the U.S. and globally, with historically marginalized groups, particularly racial and ethnic minorities, being disproportionately affected. Disproportionate representation in clinical cancer research is a consequence of inequitable access as well as a central factor contributing to outcome disparities; it limits efficacy and safety data for underrepresented groups while directing drug development to be most beneficial for those enrolled. To tackle this problem and improve the efficacy and safety of commercially available therapies, a consensus conference on strategies to promote Diversity, Equity, Inclusion, and Accessibility (DEIA) in cancer research was empaneled in September 2022. The resulting “Indianapolis Black Paper” presented here is an international collaborative white paper with authors from industry, academia, and the government, as well as patient advocacy and community health groups. First, it outlines the roles and responsibilities of key groups involved in clinical cancer research, as they relate to representation and equity. The Black Paper then delineates five steps to promote diversity in clinical research. This actionable strategy is called “DRIVE,” and it involves: incorporating a Diversity officer into clinical research studies, Ranking clinical studies for diversity, developing an Individual diversity, equity, inclusion, and access plan, a process for Verifying study diversity, and Elevating and Enhancing training of minority investigators and research team members. Finally, we outline the timeline and milestones of implementation. Purposefully ambitious and crosscutting industry, academia, and governmental policy, the Black Paper aims to address “injustices in health” with enhanced safety, purpose, and humanity.

Objective We aim to identify risk factors to enable stratification of patients' susceptibility to inflammatory arthritis immune‐related adverse events (IA‐irAEs). This retrospective study mainly examines whether preexisting osteoarthritis (OA) increases the likelihood of de novo IA‐irAEs. Methods The prevalence of OA among immune checkpoint inhibitor (ICI)–treated patients who developed IA‐irAE, those who developed other types of irAEs but not IA (non‐IA irAEs), and those who did not develop any irAEs (non‐irAEs) were compared. Electronic medical records were reviewed to extract demographic, clinical, and laboratory data. Group comparisons and logistic regression analyses were performed. Results A total of 181 de novo IA‐irAE patients, 140 non‐IA irAE patients, and 170 non‐irAE patients were included. The prevalence of OA was significantly higher in the IA‐irAE group (69%) than in the non‐IA irAE group (48%) and the non‐irAE group (48%) (both P < 0.001). The IA‐irAE group demonstrated a higher frequency of multisite OA, with more predominant hand involvement (62%) than the non‐IA irAE with OA group (13%) and the non‐irAE with OA group (13%) (both P < 0.001). A family history of autoimmune disease (AID) (odds ratio [OR] 2.03, 95% confidence interval [CI] 1.02–4.05), preexisting OA (OR 2.88, 95% CI 1.85–4.52), and melanoma (OR 2.63, 95% CI 1.56–4.47) were identified as risk factors for the development of IA‐irAE. Conclusion OA was more prevalent among ICI‐treated patients developing IA‐irAE than those who were not. Hand OA was the most common OA pattern in IA‐irAE patients. Preexisting OA, melanoma, and a family history of AID were associated with IA‐irAE.

Abstract Darier disease (DD) is a rare autosomal dominant genodermatosis. This comprehensive review, developed by the Darier Disease International Task Force (DDITF), consolidates current knowledge on the genetic basis, molecular pathophysiology, clinical presentation, diagnosis and management of DD, offering a global perspective that unites shared expertise. The disease arises from pathogenic variants in the ATP2A2 gene, which encodes sarco/endoplasmic reticulum Ca 2+ ‐ATPase isoform 2 (SERCA2), leading to disrupted calcium homeostasis and impaired desmosomal integrity. Clinically, DD is classified based on lesion type (classic vs. non‐classic) and is often accompanied by significant extracutaneous manifestations. Management remains challenging and requires a multifaceted approach, including topical therapies, systemic retinoids and lifestyle modifications. Emerging treatments that target the underlying molecular mechanisms offer promise for improved outcomes. This review aims to provide an updated reference and practical guidance for clinicians involved in the care and study of DD.

Abstract Horlock, CF, Allen, LE, Jagim, AR, Jones, MT, and Fields, JB. In-season assessment of dietary intake and match demands of men’s collegiate Rugby Sevens players. J Strength Cond Res XX(X): 000–000, 2026—Limited research has examined the external workload demands and dietary intake of collegiate men's Rugby Sevens players. Therefore, the purpose of this study was to (a) quantify match demands in Division 1-AA collegiate Rugby Sevens across a competitive season, and (b) assess players' dietary intake relative to sport-specific nutrition guidelines. Division 1-AA men's collegiate Rugby Sevens players ( n = 13; age: mass: 87 ± 14 kg; body fat %: 20 ± 4%) wore a global positional system device during all matches ( n = 17). External load metrics were total distance (TD) (m), sprint distance (>20.1 km·h −1 ), high-intensity distance (>18.1–20.0 km·h −1 ), meters per minute (m·min −1 ), acceleration efforts (#), deceleration efforts (#), sprint efforts (#), high-speed efforts (#), player load (PL) (arbitrary unit [AU]), PL per minute (AU/min), and estimated energy expenditure (EE) (kcal). Dietary intake was assessed at the start of the season using a 4-day food log. Linear mixed models examined changes in workload parameters across tournament matches. Spearman's rank correlation and linear regression assessed relationships and predictability of EE and external workloads. One-samples t test compared dietary intake relative to established guidelines ( p ≤ 0.05). No significant differences in workload metrics were observed across individual matches. Total distance ( r = 0.968, p < 0.001), m·min −1 ( r = 0.973, p < 0.001), PL ( r = 0.912, p < 0.001), and PL/min ( r = 0.855, p < 0.001) had the strongest correlations with EE. Players significantly underconsumed calories ( p = 0.028) and carbohydrates ( p < 0.01). Monitoring external workloads and assessing dietary intake can provide coaches with strategies to optimize sports performance and nutrition support to prepare players for competition demands.

PURPOSE Cholangiocarcinoma is a rare cancer associated with poor prognosis. Pemigatinib was the first FGFR1-3 inhibitor approved for second-line therapy and beyond, on the basis of the phase II FIGHT-202 trial. Here, we assess efficacy and safety of first-line pemigatinib. METHODS FIGHT-302 is a phase III, randomized, global trial evaluating pemigatinib as first-line therapy (ClinicalTrials.gov identifier: NCT03656536 ). Adults with advanced cholangiocarcinoma with FGFR2 rearrangement were randomized 1:1 to receive pemigatinib (13.5 mg once daily) or chemotherapy (1,000 mg/m 2 gemcitabine plus 25 mg/m 2 cisplatin once per day on days 1 and 8 of every 3-week cycle for ≤8 cycles) and were stratified by prior receipt of chemotherapy, geographic region, and tumor burden. Pemigatinib crossover was allowed for patients progressing on chemotherapy. The primary end point was progression-free survival (PFS). Secondary efficacy, safety, and exploratory end points were also analyzed. RESULTS Overall, 4,563 patients were prescreened, 196 were screened, and 167 randomly assigned to receive pemigatinib (n = 83) or chemotherapy (n = 84) before early closure of the study because of a change in standard of care. The median PFS was 8.3 months in the pemigatinib group versus 6.8 months in the chemotherapy group (hazard ratio, 0.58 [95% CI, 0.39 to 0.87]; nominal P = .0078); objective response rate was 47% versus 15%, and the median duration of response was 14.2 versus 6.3 months. Median overall survival was similar (24.4 v 25.0 months, respectively). In the crossover group (n = 42, second-line pemigatinib), the median PFS was 8.1 months. Safety was consistent with the known profile of pemigatinib. CONCLUSION To our knowledge, this was the largest, first-line, randomized, phase III trial of a targeted therapy for advanced FGFR2- rearranged cholangiocarcinoma. Pemigatinib demonstrated prolonged median PFS compared with chemotherapy, with no new safety findings.

Abstract Objectives This study examined the indications, frequency, and outcomes of cardiac surgery following transcatheter aortic valve replacement (TAVR) at a single institution. As TAVR volumes increase, understanding the nature and outcomes of subsequent cardiac operations is critical, particularly as the procedure expands to younger, lower-risk populations. Methods We analysed outcomes of 61 patients who underwent cardiac surgery after TAVR at our institution from August 2011 to September 2023, excluding periprocedural complications and staged procedures. Patients were stratified into 2 groups: those requiring surgical aortic valve replacement (SAVR) with or without concomitant procedures (n = 33) and those undergoing non-SAVR cardiac operations (n = 28). Data were collected from a prospectively maintained cardiovascular surgery database and electronic health records. Indications for surgery, operative characteristics, and outcomes were analysed, with survival assessed using Kaplan-Meier estimates. Results The median interval between TAVR and cardiac surgery was 19 months. Indications for SAVR included infective endocarditis (36%), non-structural valve deterioration (36%), structural valve deterioration (12%), and valve thrombosis (6%). Non-SAVR operations primarily addressed mitral valve disease (43%) and coronary artery disease (29%). Operative mortality was 6.6%, with no deaths in the endocarditis subgroup. Postoperative complications included prolonged mechanical ventilation (18%), new-onset renal failure (7%), and stroke (2%). Kaplan-Meier survival estimates were 83% at 1 year and 50% at 5 years. Conclusions Although complex, cardiac operations in patients who have undergone TAVR can be performed with acceptable mortality rates. Structural valve deterioration, paravalvular leak, and endocarditis were the primary indications for SAVR, while mitral valve and coronary artery disease predominated in non-SAVR cases. These findings highlight the importance of considering nonaortic valve pathologies in TAVR planning, particularly as the procedure expands to younger, lower-risk populations.

Abstract Introduction Despite progress in understanding placebo effects in clinical trials of inflammatory bowel disease (IBD), there is a limited understanding of how socioeconomic factors of recruiting countries impact placebo rates. We investigated the association of socioeconomic factors across recruitment sites on placebo rates in IBD randomized controlled trials. Methods We examined the association of clinical and endoscopic remission and response to the weighted Gross National Index (GNI) per capita, Human Development Index (HDI), and out-of-pocket health expenditures as a percentage of current health expenditures (OOP_CHE) of identified trials using mixed effects linear regression. Results Across 76 trials (Crohn’s disease [CD]: n = 32; ulcerative colitis [UC]: n = 44), placebo response rates over time were largely stable, with a small increase across time in clinical remission for CD trials (β = 0.4% per increase in study year, 95% CI: 0.3%-0.84%, P = .04) and a small decrease across time in endoscopic response for UC trials (β = −1.39% per increase in study year, 95% CI: −1.79, −0.99, P &lt; .001). Clinical response was most susceptible to changes in socioeconomic factors in IBD trials (β = −2.96% per 10 000 USD increase in study GNI, 95% CI: −4.98, −0.95%, P = .004; P &lt; .05 for HDI and OOP_CHE). Across both conditions, decreases in clinical response were associated with increases in HDI and OOP_CHE (CD HDI: β = −1.15% per 0.01 increase in study HDI, 95% CI: −2.24, −0.06%, P = .04; UC HDI: β = −0.66% per 0.01 increase in study HDI, 95% CI: −1.19, −0.12%, P = .02). Discussion We found that placebo clinical response was most susceptible to influences of site-level socioeconomic wellbeing. These findings highlight that estimation of placebo rates in trial planning should account for geographic location of recruiting sites.