The Ohio State University Wexner Medical Center is a multidisciplinary academic medical center located in Columbus, Ohio, United States, on the main campus of The Ohio State University. In 2012, the Ohio State Medical Center changed its name to The Ohio State University Wexner Medical Center in honor of Ohio State alumnus and The Limited founder Les Wexner. For 26 consecutive years, U.S. News & World Report has recognized Ohio State Wexner Medical Center specialties in its "Best Hospitals" rankings. In 2018, it recognized 10 Ohio State Wexner Medical Center specialties, with one program listed in the Top 10, and no others in the Top 20: ear, nose and throat (#4); nephrology (#22); cardiology and heart surgery (#24); geriatrics (#46); neurology and neurosurgery (#22); cancer (#20); orthopedics (#33); pulmonology (#20); urology (#43); and diabetes and endocrinology (#21). Additionally, two specialties were named as high performing: gastroenterology and GI surgery; and rehabilitation. In 2020, the number of ranked programs had decreased to nine; ear, nose, and throat had dropped to #5, and rehabilitation increased to #12; no other program was mentioned in the Top 20 rankings. Ohio State Wexner Medical Center was named the best hospital in central Ohio in 2018.
BackgroundRandomized clinical trials (RCTs) are considered the gold standard for evaluating the efficacy of healthcare interventions. However, conflicts of interest (COIs) can compromise the scientific integrity in these trials. This study characterized COIs in RCTs on spinal cord stimulation for chronic pain, focusing on the prevalence, disclosure, and monetary value of COIs.MethodsThis cross-sectional study analyzed RCTs published from January 1, 2013 to July 27, 2023. Primary outcomes included the presence, disclosure, and monetary value of COIs, while secondary outcomes assessed the presence of direct/indirect COIs, sponsor access to data, and associations between COIs and select variables, including journal impact factor, publication year, and study outcomes.ResultsOf 38 RCTs, 30 (78.9%) reported COIs. On average, 35.6% of authors per RCT had at least one COI, with a mean of 0.7 COIs per author. The mean annual monetary value of COIs was US$41,157.83 per author per RCT. 29 RCTs (76.3%) had undisclosed COIs, with an average of 24.2% of authors per RCT having undisclosed COIs. Sponsor access to data was reported in 67.6% of RCTs. No associations were observed between the mean percentage of authors with COIs and the monetary value of COIs and select dependent variables (impact factor, publication year, and study outcomes).ConclusionsA substantial majority of RCTs reported COIs with many authors having undisclosed conflicts, highlighting the need for stringent COI disclosure guidelines to maintain research integrity. Expanding COI registry systems globally and increasing non-industry funding are crucial steps toward enhancing transparency and reducing biases in medical research.
BACKGROUND:Persons with HIV face increased risks of major adverse cardiovascular events (MACE), partially mitigated by statin therapy. METHODS:We characterized factors associated with MACE and MACE subcomponents among PWH enrolled in REPRIEVE, globally. Our primary outcome measure was time-to-first primary MACE. Secondary outcome measures included time-to-first (1) hard MACE (cardiovascular disease [CVD] death, myocardial infarction [MI], or stroke), (2) MI, or (3) stroke. For each outcome, Cox proportional hazards models were used to estimate the hazard of baseline risk factors. RESULTS:Among participants (N = 7769), median age was 50 (Q1, Q3: 45, 55) years, and 31% were female. In fully adjusted models, risk of first MACE was higher for older individuals (50-59 and ≥60 vs 40-49 years; HR [95% CI]: 2.06 [1.54-2.76] and 2.53 [1.60-4.01]) and for those with Black/African-American race (vs White race, within HICs; HR: 1.65; 1.19-2.27), family history of premature CVD (HR: 1.53; 1.16-2.03), current cigarette smoking (HR: 2.27; 1.65-3.13), hypertension (HR: 1.77; 1.36-2.30), lower HDL cholesterol (HR: 1.21; 1.10-1.34), HIV-1 RNA ≥lower limit of quantification (LLQ) (HR: 1.40; 1.0-1.97), and a select antiretroviral therapy class combination (HR: 1.53; 1.01-2.31). Individuals from HICs had a higher risk of first MACE versus those from other regions, except South Asia. There was no apparent protective effect of female sex. Modeling for hard MACE, MI, and stroke yielded similar results for most variables. CONCLUSIONS:Among PWH in REPRIEVE, select modifiable risk factors were associated with first MACE after accounting for statin effects. Female sex was not protective. CLINICAL TRIALS REGISTRATION:NCT02344290 (ClinicalTrials.gov; date of initial registration: 22 January 2015).
BACKGROUND:People with human immunodeficiency virus (HIV, PWH) exhibit increased cardiovascular disease (CVD) risk and accelerated biological aging. REPRIEVE demonstrated that pitavastatin reduced major adverse cardiovascular events (MACE) in antiretroviral therapy (ART)-treated PWH with low-to-moderate traditional cardiovascular risk. It remains unknown whether statin therapy can modulate epigenetic aging in PWH. METHODS:We assessed epigenetic aging biomarkers using DNA methylation profiles from peripheral blood mononuclear cells (PBMCs) in a subset of 99 randomly selected US REPRIEVE participants (65 pitavastatin, 34 placebo) at baseline and 24 months. The primary outcomes were changes in second- and third-generation epigenetic clocks PCGrimAge (trained on mortality risk) and DunedinPACE (trained on rate of age-related multi-organ decline). RESULTS:Median chronological age was 57.0 (Q1, Q3: 56, 58) years and 100% of participants demonstrated epigenetic age acceleration, measured by the difference in PCGrimAge and chronological age (median difference 7.08 years [Q1, Q3: 4.69, 9.64]) at entry. Over 24 months, PCGrimAge remained accelerated with no significant differences between treatment arms (P = .89). However, the median pace of aging by the DunedinPACE increased in the placebo arm (0.036, Q1, Q3 [-0.018, 0.10], P = .021) but not in the pitavastatin arm (0.001, Q1, Q3 [-0.031, 0.036], [P = .77]), treatment group difference (P = .049). CONCLUSIONS:In this pilot study of REPRIEVE, epigenetic age acceleration was demonstrated at trial entry. The biological pace of aging increased over 24 months in the placebo group as compared to the statin group. These preliminary findings suggest pitavastatin may prevent an increase in the pace of biological aging in PWH and support further research into statin therapy as a potential intervention to mitigate accelerated aging. CLINICAL TRIALS REGISTRATION:NCT02344290 (date of initial registration: 22 January 2015).
PURPOSE:We report long-term survival and comprehensive molecular biomarker analyses of a phase II trial evaluating the combination of cetuximab and nivolumab in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). PATIENTS AND METHODS:The long-term follow-up data were obtained from a phase II trial (NCT03370276). Archived tumors and serially collected plasma cell-free DNA were characterized by comprehensive genomic analyses. Immune markers were measured in tumor cores and margins by multiplex IHC. RESULTS:At a median follow-up of 47.4 months, the median overall survival (OS) and 2-year OS rate were 12.7 months and 32% in all evaluable patients (n = 88) and 17.5 months and 35% in patients who had no prior therapy for R/M HNSCC (n = 43). The survival efficacy was similar between patients with p16-negative and p16-positive tumors, but the response rate was significantly higher in patients with p16-negative tumors. The clonal tumor mutational burden, hypoxia score, and EGFR pathway score were significantly higher in p16-negative compared with p16-positive tumors. Loss of heterozygosity of MHC class I was significantly more frequent in nonresponders, and APOBEC-associated mutagenesis was elevated in responders. Gene expression profiling and multiplex IHC analyses revealed a more inflamed tumor microenvironment in responders regardless of p16 status. CONCLUSIONS:Our long-term follow-up study indicates that the combination of cetuximab and nivolumab is efficacious and tolerable and that patients with p16-negative R/M HNSCC may have greater benefit from this combination.
INTRODUCTION:Transoral robotic surgery (TORS) is increasingly used for oropharyngeal squamous cell carcinoma (OPSCC), yet national patterns of TORS availability for Medicare beneficiaries are not well defined. We characterized hospital type, geographic distribution, and market concentration of TORS. METHODS:We conducted a retrospective cross-sectional study of inpatient Medicare claims from 2017 to 2023, identifying OPSCC with ICD-10-CM codes and TORS with ICD-10-PCS codes including a robotic-assistance qualifier. Claims were linked to inpatient prospective payment system files for hospital teaching status, disproportionate share hospital (DSH) percentage, urbanicity, and geographic labor market area (GLMA). We mapped county-level procedure counts, calculated GLMA-level Herfindahl-Hirschman Index (HHI), and used negative binomial regression to evaluate associations of hospital factors with TORS volume and inpatient length of stay (LOS). RESULTS:We identified 2499 unique TORS procedures at 161 hospitals; 86.2% occurred at teaching hospitals, and annual volume rose 31% from 2017 to 2023. TORS use was geographically diffuse but locally concentrated: among 102 GLMAs with any TORS, 64.7% had HHI = 10 000 and 28.4% had HHI 5000-9999. Six GLMAs with > 100 procedures accounted for 33.6% of all cases and were predominantly teaching centers. Higher teaching intensity was associated with greater TORS use (incidence rate ratio [IRR]: 1.99, 95% CI: 1.63-2.45). LOS was longer in urban and rural hospitals versus metropolitan centers and shorter in high-volume GLMAs (IRR: 0.82, 95% CI: 0.76-0.87). CONCLUSION:Among Medicare beneficiaries with OPSCC, TORS is concentrated in teaching hospitals and a few high-volume markets, with shorter LOS in high-volume regions, highlighting trade-offs between centralization and access.
