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Objective: To investigate whether the choice of glucose-lowering agent for type 2 diabetes (T2D) impacts a patient's risk of developing sight-threatening diabetic retinopathy complications., Design: Retrospective observational database study emulating an idealized target trial., Subjects: Adult (≥21 years) enrollees in United States commercial, Medicare Advantage, and Medicare fee-for-service plans from January 1, 2014, to December 31, 2021, with T2D and moderate cardiovascular disease (CVD) risk who had no baseline history of advanced diabetic retinal complications, initiating treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RA), sodium-glucose cotransporter 2 inhibitors (SGLT2i), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas., Methods: We used inverse propensity scoring weights in time-to-event Cox proportional hazards models., Main Outcome Measures: Treatment for either diabetic macular edema or proliferative diabetic retinopathy., Results: The final study population included 371 698 patients, of whom 42 265 initiated GLP-1 RA, 53 476 initiated SGLT2i, 78 444 initiated DPP-4i, and 197 513 initiated sulfonylurea agents. The probability of treatment for sight-threatening retinopathy within 2 and 5 years was 0.3% and 0.7% for patients initiating SGLT2i (median follow-up 830 [interquartile range (IQR), 343-1401] days), 0.4% and 1.0% for GLP-1 RA (669 [IQR, 256-1167] days), 0.4% and 0.9% for DPP-4i (1263 [IQR, 688-1938] days), and 0.5% and 1.2% for sulfonylurea (1223 [IQR, 662-1879] days). Sodium-glucose cotransporter 2 inhibitors use was associated with a lower risk of treatment for sight-threatening retinopathy compared with all other medication classes, including GLP-1 RA (hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.55-0.97), DPP-4i (HR, 0.79; 95% CI, 0.64-0.97), and sulfonylurea (HR, 0.61; 95% CI, 0.50-0.74). Glucagon-like peptide-1 receptor agonists use was associated with a similar risk of sight-threatening retinopathy as DPP-4i (HR, 1.07; 95% CI, 0.85-1.35) and sulfonylurea (HR, 0.83; 95% CI, 0.67-1.03)., Conclusions: Sodium-glucose cotransporter 2 inhibitors use was associated with a lower risk of sight-threatening diabetic retinopathy among adults with T2D and moderate CVD risk compared with other glucose-lowering therapies. Glucagon-like peptide-1 receptor agonists do not confer increased retinal risk, relative to DPP-4i and sulfonylurea medications., Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Background: Internal tremors and vibrations are symptoms previously described as part of neurologic disorders but not fully described as a part of long COVID. This study compared pre-pandemic comorbidities, new-onset conditions, and long COVID symptoms between people with internal tremors and vibrations as part of their long COVID symptoms and people with long COVID but without these symptoms., Methods: The Yale Listen to Immune, Symptom and Treatment Experiences Now (LISTEN) Study surveyed 423 adults who had long COVID between May 12, 2022 and June 1, 2023. The exposure variable was long COVID symptoms of internal tremors and vibrations. The outcome variables were demographic characteristics, pre-pandemic comorbidities, new-onset conditions, other symptoms, and quality of life., Results: Among study participants with long COVID, median age was 46 years (IQR, 38-56), 74% were female, 87% were Non-Hispanic White, and 158 (37%) reported "internal tremors, or buzzing/vibration" as a long COVID symptom. The two groups reported similar pre-pandemic comorbidities, but participants with internal tremors reported worse health as measured by the Euro-QoL visual analogue scale (median: 40 points [IQR, 30-60] vs. 50 points [IQR, 35-62], P = .007) and had higher rates of new-onset mast cell disorders (11% [95% CI, 7.1-18] vs. 2.6% [1.2-5.6], P = .008) and neurologic conditions (22% [95% CI, 16-29] vs. 8.3% [5.4-12], P = .004)., Conclusions: Among people with long COVID, those with internal tremors and vibrations had different conditions and symptoms and worse health status compared with others who had long COVID without these symptoms., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Study Objectives: To investigate the sex-specific association between habitual snoring and overall cancer prevalence and subtypes, and to examine the influence of age, body mass index (BMI), and sleep duration on this association., Methods: This study utilized data from the National Health and Nutrition Examination Survey cycles between 2005 and 2020 and included 15 892 participants aged 18 and over. We employed inverse probability of treatment weighting based on propensity scores to adjust for confounders when comparing the prevalence of cancer between habitual snorers and non-habitual snorers for each sex and cancer type. Subgroup analyses were conducted based on sleep duration, age, and BMI categories., Results: The cohort (mean age 48.2 years, 50.4% female, and 30.5% habitual snorers) reported 1385 cancer cases. In men, habitual snoring was linked to 26% lower odds of any cancer (OR 0.74, 95% CI: 0.66 to 0.83), while in women, it showed no significant difference except lower odds of breast cancer (OR 0.77, 95% CI: 0.63 to 0.94) and higher odds of cervix cancer (OR 1.54, 95% CI: 1.18 to 2.01). Age and sleep duration significantly influenced the snoring-cancer relationship, with notable variations by cancer type and sex., Conclusions: Habitual snoring exhibits sex-specific associations with cancer prevalence, showing lower prevalence in men and varied results in women. These findings emphasize the critical need for further research to uncover the biological mechanisms involved. Future investigations should consider integrating sleep characteristics with cancer prevention and screening strategies, focusing on longitudinal research and the integration of genetic and biomarker analyses to fully understand these complex relationships., (© The Author(s) 2024. Published by Oxford University Press on behalf of Sleep Research Society.)

Objective: To evaluate the effectiveness of a clinical decision support system (CDSS) in improving the use of guideline accordant antihypertensive treatment in primary care settings in China., Design: Pragmatic, open label, cluster randomised trial., Setting: 94 primary care practices in four urban regions of China between August 2019 and July 2022: Luoyang (central China), Jining (east China), and Shenzhen (south China, including two regions)., Participants: 94 practices were randomised (46 to CDSS, 48 to usual care). 12 137 participants with hypertension who used up to two classes of antihypertensives and had a systolic blood pressure <180 mm Hg and diastolic blood pressure <110 mm Hg were included., Interventions: Primary care practices were randomised to use an electronic health record based CDSS, which recommended a specific guideline accordant regimen for initiation, titration, or switching of antihypertensive (the intervention), or to use the same electronic health record without CDSS and provide treatment as usual (control)., Main Outcome Measures: The primary outcome was the proportion of hypertension related visits during which an appropriate (guideline accordant) treatment was provided. Secondary outcomes were the average reduction in systolic blood pressure and proportion of participants with controlled blood pressure (<140/90 mm Hg) at the last scheduled follow-up. Safety outcomes were patient reported antihypertensive treatment related events, including syncope, injurious fall, symptomatic hypotension or systolic blood pressure <90 mm Hg, and bradycardia., Results: 5755 participants with 23 113 visits in the intervention group and 6382 participants with 27 868 visits in the control group were included. Mean age was 61 (standard deviation 13) years and 42.5% were women. During a median 11.6 months of follow-up, the proportion of visits at which appropriate treatment was given was higher in the intervention group than in the control group (77.8% (17 975/23 113) v 62.2% (17 328/27 868); absolute difference 15.2 percentage points (95% confidence interval (CI) 10.7 to 19.8); P<0.001; odds ratio 2.17 (95% CI 1.75 to 2.69); P<0.001). Compared with participants in the control group, those in the intervention group had a 1.6 mm Hg (95% CI -2.7 to -0.5) greater reduction in systolic blood pressure (-1.5 mm Hg v 0.3 mm Hg; P=0.006) and a 4.4 percentage point (95% CI -0.7 to 9.5) improvement in blood pressure control rate (69.0% (3415/4952) v 64.6% (3778/5845); P=0.07). Patient reported antihypertensive treatment related adverse effects were rare in both groups., Conclusions: Use of a CDSS in primary care in China improved the provision of guideline accordant antihypertensive treatment and led to a modest reduction in blood pressure. The CDSS offers a promising approach to delivering better care for hypertension, both safely and efficiently., Trial Registration: ClinicalTrials.gov NCT03636334., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-of-interest/ and declare: support from the Chinese Academy of Medical Sciences and the Sanming Project of Medicine in Shenzhen; in the past three years, HMK received options for Element Science and Identifeye and payments from F-Prime for advisory roles, and he is a cofounder of, and holds equity in, Hugo Health, Refactor Health, and Ensight-AI, and he is associated with research contracts through Yale University from Janssen, Kenvue, and Pfizer; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Individuals with long COVID lack evidence-based treatments and have difficulty participating in traditional site-based trials. Our digital, decentralized trial investigates the efficacy and safety of nirmatrelvir/ritonavir, targeting viral persistence as a potential cause of long COVID., Methods: The PAX LC trial (NCT05668091) is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled trial in 100 community-dwelling, highly symptomatic adult participants with long COVID residing in the 48 contiguous US states to determine the efficacy, safety, and tolerability of 15 days of nirmatrelvir/ritonavir compared with placebo/ritonavir. Participants are recruited via patient groups, cultural ambassadors, and social media platforms. Medical records are reviewed through a platform facilitating participant-mediated data acquisition from electronic health records nationwide. During the drug treatment, participants complete daily digital diaries using a web-based application. Blood draws for eligibility and safety assessments are conducted at or near participants' homes. The study drug is shipped directly to participants' homes. The primary endpoint is the PROMIS-29 Physical Health Summary Score difference between baseline and Day 28, evaluated by a mixed model repeated measure analysis. Secondary endpoints include PROMIS-29 (Mental Health Summary Score and all items), Modified GSQ-30 with supplemental symptoms questionnaire, COVID Core Outcome Measures for Recovery, EQ-5D-5L (Utility Score and all items), PGIS 1 and 2, PGIC 1 and 2, and healthcare utilization. The trial incorporates immunophenotyping to identify long COVID biomarkers and treatment responders., Conclusion: The PAX LC trial uses a novel decentralized design and a participant-centric approach to test a 15-day regimen of nirmatrelvir/ritonavir for long COVID., (Copyright © 2024. Published by Elsevier Inc.)

Objective: To determine the relative hazards of acute and chronic diabetes complications among people with diabetes across the U.S. rural-urban continuum., Research Design and Methods: This retrospective cohort study used the OptumLabs Data Warehouse, a deidentified data set of U.S. commercial and Medicare Advantage beneficiaries, to follow 2,901,563 adults (age ≥18 years) with diabetes between 1 January 2012 and 31 December 2021. We compared adjusted hazard ratios (HRs) of diabetes complications in remote areas (population <2,500), small towns (population 2,500-50,000), and cities (population >50,000)., Results: Compared with residents of cities, residents of remote areas had greater hazards of myocardial infarction (HR 1.06 [95% CI 1.02-1.10]) and revascularization (HR 1.04 [1.02-1.06]) but lower hazards of hyperglycemia (HR 0.90 [0.83-0.98]) and stroke (HR 0.91 [0.88-0.95]). Compared with cities, residents of small towns had greater hazards of hyperglycemia (HR 1.06 [1.02-1.10]), hypoglycemia (HR 1.15 [1.12-1.18]), end-stage kidney disease (HR 1.04 [1.03-1.06]), myocardial infarction (HR 1.10 [1.08-1.12]), heart failure (HR 1.05 [1.03-1.06]), amputation (HR 1.05 [1.02-1.09]), other lower-extremity complications (HR 1.02 [1.01-1.03]), and revascularization (HR 1.05 [1.04-1.06]) but a smaller hazard of stroke (HR 0.95 [0.94-0.97]). Compared with small towns, residents of remote areas had lower hazards of hyperglycemia (HR 0.85 [0.78-0.93]), hypoglycemia (HR 0.92 [0.87-0.97]), and heart failure (HR 0.94 [0.91-0.97]). Hazards of retinopathy and atrial fibrillation/flutter did not vary geographically., Conclusions: Adults in small towns are disproportionately impacted by complications of diabetes. Future studies should probe for the reasons underlying these disparities., (© 2024 by the American Diabetes Association.)

Importance: The Centers for Medicare & Medicaid Services (CMS) Overall Star Rating is widely used by patients and consumers, and there is continued stakeholder curiosity surrounding the inclusion of a peer grouping step, implemented to the 2021 Overall Star Rating methods., Objective: To calculate hospital star rating scores with and without the peer grouping step, with the former approach stratifying hospitals into 3-, 4-, and 5-measure group peer groups based on the number of measure groups with at least 3 reported measures., Design, Setting, and Participants: This cross-sectional study used Care Compare website data from January 2023 for 3076 hospitals that received a star rating in 2023. Data were analyzed from April 2023 to December 2023., Exposure: Peer grouping vs no peer grouping., Main Outcomes and Measures: The primary outcome was the distribution of star ratings, with 1 star being the lowest-performing hospitals and 5 stars, the highest. Analyses additionally identified the number of hospitals with a higher, lower, or identical star rating with the use of the peer grouping step compared with its nonuse, stratified by certain hospital characteristics., Results: Among 3076 hospitals that received a star rating in 2023, most were nonspecialty (1994 hospitals [64.8%]), nonteaching (1807 hospitals [58.7%]), non-safety net (2326 hospitals [75.6%]), non-critical access (2826 hospitals [91.9%]) hospitals with fewer than 200 beds (1822 hospitals [59.2%]) and located in an urban geographic designations (1935 hospitals [62.9%]). The presence of the peer grouping step resulted in 585 hospitals (19.0%) being assigned a different star rating than if the peer grouping step was absent, including considerably more hospitals receiving a higher star rating (517 hospitals) rather than a lower (68 hospitals) star rating. Hospital characteristics associated with a higher star rating included urbanicity (351 hospitals [67.9%]), non-safety net status (414 hospitals [80.1%]), and fewer than 200 beds (287 hospitals [55.6%]). Collectively, the presence of the peer grouping step supports a like-to-like comparison among hospitals and supports the ability of patients to assess overall hospital quality., Conclusions and Relevance: In this cross-sectional study, inclusion of the peer grouping in the CMS star rating method resulted in modest changes in hospital star ratings compared with application of the method without peer grouping. Given improvement in face validity and the close association between the current peer grouping approach and stakeholder needs for peer-comparison, the current CMS Overall Star Rating method allows for durable comparisons in hospital performance.

Background: The experience of people with long COVID needs further amplification, especially with a comprehensive focus on symptomatology, treatments, and the impact on daily life and finances. Our intent is to describe the experience of people with long COVID symptomatology and characterize the psychological, social, and financial challenges they experience., Methods: We collected data from individuals aged 18 and older reporting long COVID as participants in the Yale Listen to Immune, Symptom and Treatment Experiences Now study. The sample population included 441 participants surveyed between May 2022 and July 2023. We evaluated their demographic characteristics, socioeconomic and psychological status, index infection period, health status, quality of life, symptoms, treatments, prepandemic comorbidities, and new-onset conditions., Results: Overall, the median age of the participants with long COVID was 46 years (interquartile range [IQR]: 38-57 years); 74% were women, 86% were non-Hispanic White, and 93% were from the United States. Participants reported a low health status measured by the Euro-QoL visual analog scale, with a median score of 49 (IQR: 32-61). Participants documented a diverse range of symptoms, with all 96 possible symptom choices being reported. Additionally, participants had tried many treatments (median number of treatments: 19, IQR: 12-28). They were also experiencing psychological distress, social isolation, and financial stress., Conclusions: Despite having tried numerous treatments, participants with long COVID continued to experience an array of health and financial challenges-findings that underscore the failure of the healthcare system to address the medical needs of people with long COVID. These insights highlight the need for crucial medical, mental health, financial, and community support services, as well as further scientific investigation to address the complex impact of long COVID., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Cardiovascular disease (CVD) is the leading cause of death among people with type 2 diabetes 1-5 , most of whom are at moderate CVD risk 6 , yet there is limited evidence on the preferred choice of glucose-lowering medication for CVD risk reduction in this population. Here, we report the results of a retrospective cohort study where data for US adults with type 2 diabetes and moderate risk for CVD are used to compare the risks of experiencing a major adverse cardiovascular event with initiation of glucagon-like peptide-1 receptor agonists (GLP-1RA; n = 44,188), sodium-glucose cotransporter 2 inhibitors (SGLT2i; n = 47,094), dipeptidyl peptidase-4 inhibitors (DPP4i; n = 84,315) and sulfonylureas ( n = 210,679). Compared to DPP4i, GLP-1RA (hazard ratio (HR) 0.87; 95% confidence interval (CI) 0.82-0.93) and SGLT2i (HR 0.85; 95% CI 0.81-0.90) were associated with a lower risk of a major adverse cardiovascular event, whereas sulfonylureas were associated with a higher risk (HR 1.19; 95% CI 1.16-1.22). Thus, GLP-1RA and SGLT2i may be the preferred glucose-lowering agents for cardiovascular risk reduction in patients at moderate baseline risk for CVD. ClinicalTrials.gov registration: NCT05214573.

Importance: Preventing diabetes complications requires monitoring and control of hyperglycemia and cardiovascular risk factors. Switching to high-deductible health plans (HDHPs) has been shown to hinder aspects of diabetes care; however, the association of HDHP enrollment with microvascular and macrovascular diabetes complications is unknown., Objective: To examine the association between an employer-required switch to an HDHP and incident complications of diabetes., Design, Setting, and Participants: This retrospective cohort study used deidentified administrative claims data for US adults with diabetes enrolled in employer-sponsored health plans between January 1, 2010, and December 31, 2019. Data analysis was performed from May 26, 2022, to January 2, 2024., Exposures: Adults with a baseline year of non-HDHP enrollment who had to switch to an HDHP because their employer offered no non-HDHP alternative in that year were compared with adults who were continuously enrolled in a non-HDHP., Main Outcomes and Measures: Mixed-effects logistic regression models examined the association between switching to an HDHP and, individually, the odds of myocardial infarction, stroke, hospitalization for heart failure, lower-extremity complication, end-stage kidney disease, proliferative retinopathy, treatment for retinopathy, and blindness. Models were adjusted for demographics, comorbidities, and medications, with inverse propensity score weighting used to account for potential selection bias., Results: The study included 42 326 adults who switched to an HDHP (mean [SD] age, 52 [10] years; 19 752 [46.7%] female) and 202 729 adults who did not switch (mean [SD] age, 53 [10] years; 89 828 [44.3%] female). Those who switched to an HDHP had greater odds of experiencing all diabetes complications (odds ratio [OR], 1.11; 95% CI, 1.06-1.16 for myocardial infarction; OR, 1.15; 95% CI, 1.09-1.21 for stroke; OR, 1.35; 95% CI, 1.30-1.41 for hospitalization for heart failure; OR, 2.53; 95% CI, 2.38-2.70 for end-stage kidney disease; OR, 2.23; 95% CI, 2.17-2.29 for lower-extremity complication; OR, 1.17; 95% CI, 1.13-1.21 for proliferative retinopathy; OR, 2.35; 95% CI, 2.18-2.54 for blindness; and OR, 2.28; 95% CI, 2.15-2.41 for retinopathy treatment)., Conclusions and Relevance: This study found that an employer-driven switch to an HDHP was associated with increased odds of experiencing all diabetes complications. These findings reinforce the potential harm associated with HDHPs for people with diabetes and the importance of affordable and accessible chronic disease management, which is hindered by high out-of-pocket costs incurred by HDHPs.

Background: Immigrants to the United States face structural barriers that contribute to rising cardiovascular risk factors and obesity after immigration. This manuscript describes the development of the Healthy Immigrant Community protocol and baseline measures for a stepped wedge cluster randomized trial to test the effectiveness of a social network intervention for cardiovascular risk reduction among two immigrant populations., Methods: We developed a social network-informed, community-based, participatory research-derived health promotion intervention with Hispanic and Somali immigrant communities in Minnesota consisting of mentoring, educational and motivational sessions, group activities, and a community toolkit for healthy weight loss delivered by culturally concordant health promoters (HPs) to their social networks. Using a stepped wedge cluster randomized design, social network-based groups were randomly assigned to receive the intervention either immediately or after a delay of one year. Outcomes, measured at baseline, 6 months, 12 months, and 24 months, were derived from the American Heart Association's "Life's Simple 7": BMI and waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, and dietary quality., Results: A total of 51 HPs were enrolled and randomized (29 Hispanic; 22 Somali). There were 475 participants enrolled in the study, representing a mean social network group size of 8 (range, 5-12). The mean BMI of the sample (32.2) was in the "obese" range., Conclusion: Processes and products from this Healthy Immigrant Community protocol are relevant to other communities seeking to reduce cardiovascular risk factors and negative health behaviors among immigrant populations by leveraging the influence of their social networks., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Major adverse cardiovascular events (MACE) are a leading cause of morbidity and mortality among adults with type 2 diabetes. Currently, available MACE prediction models have important limitations, including reliance on data that may not be routinely available, narrow focus on primary prevention, limited patient populations, and longtime horizons for risk prediction., Objectives: The purpose of this study was to derive and internally validate a claims-based prediction model for 1-year risk of MACE in type 2 diabetes., Methods: Using medical and pharmacy claims for adults with type 2 diabetes enrolled in commercial, Medicare Advantage, and Medicare fee-for-service plans between 2014 and 2021, we derived and internally validated the annualized claims-based MACE estimator (ACME) model to predict the risk of MACE (nonfatal acute myocardial infarction, nonfatal stroke, and all-cause mortality). The Cox proportional hazards model was composed of 30 covariates, including patient age, sex, comorbidities, and medications., Results: The study cohort comprised 6,623,526 adults with type 2 diabetes, mean age 68.1 ± 10.6 years, 49.8% women, and 73.0% Non-Hispanic White. ACME had a concordance index of 0.74 (validation index range: 0.739-0.741). The predicted 1-year risk of the study cohort ranged from 0.4% to 99.9%, with a median risk of 3.4% (IQR: 2.3%-6.5%)., Conclusions: ACME was derived in a large usual care population, relies on routinely available data, and estimates short-term MACE risk. It can support population risk stratification at the health system and payer levels, participant identification for decentralized clinical trials of cardiovascular disease, and risk-stratified observational studies using real-world data., Competing Interests: Research reported in this work was funded through a 10.13039/100006093Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-1409-24099). In the last 36 months, Dr McCoy has received support from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institute of Health (NIH), the National Institute on Aging (NIA) of the NIH, and the National Center for Advancing Translational Sciences (NCATS) for projects unrelated to this work; and serves as a consultant to Emmi (Wolters Kluwer) on developing patient education materials related to diabetes. Dr Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program, from the Agency for Healthcare Research and Quality, from the National Heart, Lung and Blood Institute of the NIH, and from Arnold Ventures; and he is an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc; all unrelated to this work. Dr Galindo is supported in part by grants from NIDDK and received unrestricted research support (to Emory University) from Novo Nordisk, Eli Lilly, and Dexcom; and consulting fees from Sanofi, Novo Nordisk, Eli Lilly, Pfizer, Boehringer, Bayer, and Weight Watchers; all of which are unrelated to this work. Dr Umpierrez is partly supported by research grants from the Clinical and Translational Science Award program and NIDDK and has received research support (to Emory University) from AstraZeneca, Bayer, Abbott, and Dexcom, all of which are unrelated to this work. Dr Borah has received consulting fees from Boehringer-Ingelheim and Exact Sciences on projects unrelated to this work. Dr Herrin has received funding from the Centers for Medicare and Medicaid Services to develop measures of quality, from the NIH, NIA, National Cancer Institute (NCI), National Heart Lung and Blood Institute (NHLBI), National Institutes of Neurological Disorders and Stroke (NINDS), and PCORI for projects unrelated to this work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Importance: Equity is an essential domain of health care quality. The Centers for Medicare & Medicaid Services (CMS) developed 2 Disparity Methods that together assess equity in clinical outcomes., Objectives: To define a measure of equitable readmissions; identify hospitals with equitable readmissions by insurance (dual eligible vs non-dual eligible) or patient race (Black vs White); and compare hospitals with and without equitable readmissions by hospital characteristics and performance on accountability measures (quality, cost, and value)., Design, Setting, and Participants: Cross-sectional study of US hospitals eligible for the CMS Hospital-Wide Readmission measure using Medicare data from July 2018 through June 2019., Main Outcomes and Measures: We created a definition of equitable readmissions using CMS Disparity Methods, which evaluate hospitals on 2 methods: outcomes for populations at risk for disparities (across-hospital method); and disparities in care within hospitals' patient populations (within-a-single-hospital method)., Exposures: Hospital patient demographics; hospital characteristics; and 3 measures of hospital performance-quality, cost, and value (quality relative to cost)., Results: Of 4638 hospitals, 74% served a sufficient number of dual-eligible patients, and 42% served a sufficient number of Black patients to apply CMS Disparity Methods by insurance and race. Of eligible hospitals, 17% had equitable readmission rates by insurance and 30% by race. Hospitals with equitable readmissions by insurance or race cared for a lower percentage of Black patients (insurance, 1.9% [IQR, 0.2%-8.8%] vs 3.3% [IQR, 0.7%-10.8%], P < .01; race, 7.6% [IQR, 3.2%-16.6%] vs 9.3% [IQR, 4.0%-19.0%], P = .01), and differed from nonequitable hospitals in multiple domains (teaching status, geography, size; P < .01). In examining equity by insurance, hospitals with low costs were more likely to have equitable readmissions (odds ratio, 1.57 [95% CI, 1.38-1.77), and there was no relationship between quality and value, and equity. In examining equity by race, hospitals with high overall quality were more likely to have equitable readmissions (odds ratio, 1.14 [95% CI, 1.03-1.26]), and there was no relationship between cost and value, and equity., Conclusion and Relevance: A minority of hospitals achieved equitable readmissions. Notably, hospitals with equitable readmissions were characteristically different from those without. For example, hospitals with equitable readmissions served fewer Black patients, reinforcing the role of structural racism in hospital-level inequities. Implementation of an equitable readmission measure must consider unequal distribution of at-risk patients among hospitals.

Importance: Despite availability of a safe and effective vaccine, an estimated 36 500 new cancers in the US result from human papillomavirus (HPV) annually. HPV vaccine uptake falls short of national public health goals and lags other adolescent vaccines., Objective: To evaluate the individual and combined impact of 2 evidence-based interventions on HPV vaccination rates among 11- and 12-year-old children., Design, Setting, and Participants: The study team conducted a cluster randomized clinical trial with a stepped-wedge factorial design at 6 primary care practices affiliated with Mayo Clinic in southeastern Minnesota. Using block randomization to ensure balance of patient volumes across interventions, each practice was allocated to a sequence of four 12-month steps with the initial baseline step followed by 2 intermediate steps (none, 1, or both interventions) and a final step wherein all practices implemented both interventions. Each month, all eligible children who turned 11 or 12 years in the 2 months prior were identified and followed until the end of the step. Data were analyzed from April 2018 through March 2019. Participants included children who turned 11 or 12 years old and were due for a dose of the HPV vaccine., Interventions: Parents of eligible patients were mailed reminder/recalls following their child's birthdays. Health care professionals received confidential audit/feedback on their personal in-office success with HPV vaccine uptake via intra-campus mail. These 2 interventions were assessed separately and in combination., Main Outcomes and Measures: Eligible patients' receipt of any valid dose of HPV vaccine during the study step., Results: The cohort was comprised of 9242 11-year-olds (5165 [55.9%]) and 12-year-olds (4077 [44.1%]), and slightly more males (4848 [52.5%]). Parent reminder/recall resulted in 34.6% receiving a dose of HPV vaccine, health care professional audit/feedback, 30.4%, both interventions together resulted in 39.7%-all contrasted to usual care, 21.9%. Compared with usual care, the odds of HPV vaccination were higher for parent reminder/recall (odds ratio [OR], 1.56; 95% CI, 1.23-1.97) and for the combination of parent reminder/recall and health care professional audit/feedback (OR, 2.03; 95% CI, 1.44-2.85). Health care professional audit/feedback alone did not differ significantly from usual care (OR, 1.19; 95% CI, 0.94-1.51)., Conclusions and Relevance: In this cluster randomized trial, the combination of parent reminder/recall and health care professional audit/feedback increased the odds of HPV vaccination compared with usual care. These findings underscore the value of simultaneous implementation of evidence-based strategies to improve HPV vaccination.

Purpose: Gender disparities among the senior echelons of academic medicine are striking and persistent. The role of medical school dean has been particularly immune to gender diversity, and limited prior research identified women's shorter decanal tenures as a potential driver. The authors assessed gender differences in tenure length of deanships in the current era to elucidate this finding., Method: From October 2020 to June 2021, the authors collected information about medical school deanships that were held from January 1, 2006, to June 30, 2020. All schools were members of the Association of American Medical Colleges (AAMC). The authors collected data from online public records and augmented their findings via direct outreach to medical schools. They used time-to-event analyses before and after adjustment for interim vs permanent status of the initial appointment, school ownership (public/private), and school size to assess for gender differences in length of deanship tenure during the study period. The unit of analysis was deanships, and the primary outcome was length of deanships measured in years., Results: Authors included data on 528 deanships. Women held 91 (17%) of these terms. Men held the majority of permanent deanships (n = 352 [85%]). A greater percentage of the deanships held by women were interim only (n = 27 [30%]) compared with men (n = 85 [20%]). In unadjusted and adjusted analyses, there were no significant gender differences in length of deanship tenures., Conclusions: Analysis of appointments of AAMC-member medical school deans from 2006 to 2020 revealed that women have remained in their deanships as long as their male counterparts. The myth about women deans' shorter longevity should no longer be promulgated. Academic medicine should consider novel solutions to addressing women's persistent underrepresentation in the dean role, including employing the gender proportionality principle used in the business and legal communities., (Copyright © 2023 the Association of American Medical Colleges.)

Background/aims: There has been growing interest in better understanding the potential of observational research methods in medical product evaluation and regulatory decision-making. Previously, we used linked claims and electronic health record data to emulate two ongoing randomized controlled trials, characterizing the populations and results of each randomized controlled trial prior to publication of its results. Here, our objective was to compare the populations and results from the emulated trials with those of the now-published randomized controlled trials., Methods: This study compared participants' demographic and clinical characteristics and study results between the emulated trials, which used structured data from OptumLabs Data Warehouse, and the published PRONOUNCE and GRADE trials. First, we examined the feasibility of implementing the baseline participant characteristics included in the published PRONOUNCE and GRADE trials' using real-world data and classified each variable as ascertainable, partially ascertainable, or not ascertainable. Second, we compared the emulated trials and published randomized controlled trials for baseline patient characteristics (concordance determined using standardized mean differences <0.20) and results of the primary and secondary endpoints (concordance determined by direction of effect estimates and statistical significance)., Results: The PRONOUNCE trial enrolled 544 participants, and the emulated trial included 2226 propensity score-matched participants. In the PRONOUNCE trial publication, one of the 32 baseline participant characteristics was listed as an exclusion criterion on ClinicalTrials.gov but was ultimately not used. Among the remaining 31 characteristics, 9 (29.0%) were ascertainable, 11 (35.5%) were partially ascertainable, and 10 (32.2%) were not ascertainable using structured data from OptumLabs. For one additional variable, the PRONOUNCE trial did not provide sufficient detail to allow its ascertainment. Of the nine variables that were ascertainable, values in the emulated trial and published randomized controlled trial were discordant for 6 (66.7%). The primary endpoint of time from randomization to the first major adverse cardiovascular event and secondary endpoints of nonfatal myocardial infarction and stroke were concordant between the emulated trial and published randomized controlled trial. The GRADE trial enrolled 5047 participants, and the emulated trial included 7540 participants. In the GRADE trial publication, 8 of 34 (23.5%) baseline participant characteristics were ascertainable, 14 (41.2%) were partially ascertainable, and 11 (32.4%) were not ascertainable using structured data from OptumLabs. For one variable, the GRADE trial did not provide sufficient detail to allow for ascertainment. Of the eight variables that were ascertainable, values in the emulated trial and published randomized controlled trial were discordant for 4 (50.0%). The primary endpoint of time to hemoglobin A1c ≥7.0% was mostly concordant between the emulated trial and the published randomized controlled trial., Conclusion: Despite challenges, observational methods and real-world data can be leveraged in certain important situations for a more timely evaluation of drug effectiveness and safety in more diverse and representative patient populations., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Wallach reported receiving research support through the Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT) at Yale University from Arnold Ventures and through the Yale–Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938) and being supported by the National Institute on Alcohol Abuse and Alcoholism of the National Institutes of Health under award K01A A028258. Dr McCoy reported receiving support from the National Institute of Health National Institute of Diabetes and Digestive and Kidney Diseases (K23DK114497, R03 DK127010), the National Institute on Aging (R01AG 079113), and the Patient-Centered Outcomes Research Institute (DB-2020C2-20306). She also serves as a consultant to Emmi® (Wolters Kluwer) on developing patient education materials related to diabetes. Dr Dhruva reported being funded by the Department of Veterans Affairs, the National Evaluation System for Health Technology (NEST), and Arnold Ventures. Dr Herrin reported working under contract to the Centers for Medicare & Medicaid Services on the development and evaluations of measures of health care quality. Dr Noseworthy reported receiving personal fees from Optum during the conduct of the study. Dr Shah reported receiving support through the Mayo Clinic from the Food and Drug Administration to establish the Yale–Mayo Clinic CERSI program (U01FD005938); the Centers for Medicare & Medicaid Innovation under the Transforming Clinical Practice Initiative; the Agency for Healthcare Research and Quality (R01HS025164, R01HS025402, R03HS025517, and K12HS026379); the National Heart, Lung, and Blood Institute of the U.S. National Institutes of Health (R56HL130496, R01HL131535, and R01HL151662); the National Science Foundation; and the Patient-Centered Outcomes Research Institute to develop a clinical data research network (LHSNet). Dr. Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from Arnold Ventures; in addition, Dr. Ross was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled September 2022.

Background: The ThermoCool STSF catheter is used for ablation of ischemic ventricular tachycardia (VT) in routine clinical practice, although outcomes have not been studied and the catheter does not have Food and Drug Administration (FDA) approval for this indication. We used real-world health system data to evaluate its safety and effectiveness for this indication., Methods: Among patients undergoing ischemic VT ablation with the ThermoCool STSF catheter pooled across two health systems (Mercy Health and Mayo Clinic), the primary safety composite outcome of death, thromboembolic events, and procedural complications within 7 days was compared to a performance goal of 15%, which is twice the expected proportion of the primary composite safety outcome based on prior studies. The exploratory effectiveness outcome of rehospitalization for VT or heart failure or repeat VT ablation at up to 1 year was averaged across health systems among patients treated with the ThermoCool STSF vs. ST catheters., Results: Seventy total patients received ablation for ischemic VT using the ThermoCool STSF catheter. The primary safety composite outcome occurred in 3/70 (4.3%; 90% CI, 1.2-10.7%) patients, meeting the pre-specified performance goal, p = 0.0045. At 1 year, the effectiveness outcome risk difference (STSF-ST) at Mercy was - 0.4% (90% CI: - 25.2%, 24.3%) and at Mayo Clinic was 12.6% (90% CI: - 13.0%, 38.4%); the average risk difference across both institutions was 5.8% (90% CI: - 12.0, 23.7)., Conclusions: The ThermoCool STSF catheter was safe and appeared effective for ischemic VT ablation, supporting continued use of the catheter and informing possible FDA label expansion. Health system data hold promise for real-world safety and effectiveness evaluation of cardiovascular devices., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: Our research consortium is preparing for a prospective multicenter trial evaluating the impact of teleneonatology on the health outcomes of at-risk neonates born in community hospitals. We completed a 6-month pilot study to determine the feasibility of the trial protocol., Methods: Four neonatal intensive care units ("hubs") and four community hospitals ("spokes") participated in the pilot-forming four hub-spoke dyads. Two hub-spoke dyads implemented synchronous, audio-video telemedicine consultations with a neonatologist ("teleneonatology"). The primary outcome was a composite feasibility score that included one point for each of the following: site retention, on-time screening log completion, no eligibility errors, on-time data submission, and sponsor site-dyad meeting attendance (score range 0-5)., Results: For the 20 hub-spoke dyad months, the mean (range) composite feasibility score was 4.6 (4, 5). All sites were retained during the pilot. Ninety percent (18/20) of screening logs were completed on time. The eligibility error rate was 0.2% (3/1809). On-time data submission rate was 88.4% (84/95 case report forms). Eighty-five percent (17/20) of sponsor site-dyad meetings were attended by both hub and spoke site staff., Conclusions: A multicenter teleneonatology clinical effectiveness trial is feasible. Learnings from the pilot study may improve the likelihood of success of the main trial., Impact: A prospective, multicenter clinical trial evaluating the impact of teleneonatology on the early health outcomes of at-risk neonates born in community hospitals is feasible. A multidimensional composite feasibility score, which includes processes and procedures fundamental to completing a clinical trial, is useful for quantitatively measuring pilot study success. A pilot study allows the investigative team to test trial methods and materials to identify what works well or requires modification. Learnings from a pilot study may improve the quality and efficiency of the main effectiveness trial., (© 2023. The Author(s), under exclusive licence to the International Pediatric Research Foundation, Inc.)

Objective: We aimed to measure provider perspectives on the acceptability, appropriateness, and feasibility of teleneonatology in neonatal intensive care units (NICUs) and community hospitals., Study Design: Providers from five academic tertiary NICUs and 27 community hospitals were surveyed using validated implementation measures to assess the acceptability, appropriateness, and feasibility of teleneonatology. For each of the 12 statements, scale values ranged from 1 to 5 (1 = strongly disagree; 5 = strongly agree), with higher scores indicating greater positive perceptions. Survey results were summarized, and differences across respondents assessed using generalized linear models., Results: The survey response rate was 56% (203/365). Respondents found teleneonatology to be acceptable, appropriate, and feasible. The percent of respondents who agreed with each of the twelve statements ranged from 88.6 to 99.0%, with mean scores of 4.4 to 4.7 and median scores of 4.0 to 5.0. There was no difference in the acceptability, appropriateness, and feasibility of teleneonatology when analyzed by professional role, years of experience in neonatal care, or years of teleneonatology experience. Respondents from Level I well newborn nurseries had greater positive perceptions of teleneonatology than those from Level II special care nurseries., Conclusion: Providers in tertiary NICUs and community hospitals perceive teleneonatology to be highly acceptable, appropriate, and feasible for their practices. The wide acceptance by providers of all roles and levels of experience likely demonstrates a broad receptiveness to telemedicine as a tool to deliver neonatal care, particularly in rural communities where specialists are unavailable., Key Points: · Neonatal care providers perceive teleneonatology to be highly acceptable, appropriate, and feasible.. · Perceptions of teleneonatology do not differ based on professional role or years of experience.. · Perceptions of teleneonatology are especially high in smaller hospitals with well newborn nurseries.., Competing Interests: J.L.F. and C.E.C. have licensed intellectual property and earn royalties from Teladoc Health, and J.L.F. owns stock in the company. B.M.D., H.W., J.H., R.U., J.L., A.M., R.M.J., M.D.L., R.Y., and M.M. have no conflict of interest relevant to this article to disclose., (Thieme. All rights reserved.)

Introduction: Social and behavioral determinants of health (SBDH) have been linked to diabetes risk, but their role in explaining variations in cardiometabolic risk across race/ethnicity in US adults is unclear. This study aimed to classify adults into distinct cardiometabolic risk subgroups using SBDH and clinically measured metabolic risk factors, while comparing their associations with undiagnosed diabetes and pre-diabetes by race/ethnicity., Research Design and Methods: We analyzed data from 38,476 US adults without prior diabetes diagnosis from the National Health and Nutrition Examination Survey (NHANES) 1999-2018. The k-prototypes clustering algorithm was used to identify subgroups based on 16 SBDH and 13 metabolic risk factors. Each participant was classified as having no diabetes, pre-diabetes or undiagnosed diabetes using contemporaneous laboratory data. Logistic regression was used to assess associations between subgroups and diabetes status, focusing on differences by race/ethnicity., Results: Three subgroups were identified: cluster 1, primarily middle-aged adults with high rates of smoking, alcohol use, short sleep duration, and low diet quality; cluster 2, mostly young non-white adults with low income, low health insurance coverage, and limited healthcare access; and cluster 3, mostly older males who were the least physically active, but with high insurance coverage and healthcare access. Compared with cluster 2, adjusted ORs (95% CI) for undiagnosed diabetes were 14.9 (10.9, 20.2) in cluster 3 and 3.7 (2.8, 4.8) in cluster 1. Clusters 1 and 3 (vs cluster 2) had high odds of pre-diabetes, with ORs of 1.8 (1.6, 1.9) and 2.1 (1.8, 2.4), respectively. Race/ethnicity was found to modify the relationship between identified subgroups and pre-diabetes risk., Conclusions: Self-reported SBDH combined with metabolic factors can be used to classify adults into subgroups with distinct cardiometabolic risk profiles. This approach may help identify individuals who would benefit from screening for diabetes and pre-diabetes and potentially suggest effective prevention strategies., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To build on the recently completed GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) randomised trial examining the comparative effectiveness of second line glucose lowering drugs in achieving and maintaining glycaemic control in adults with type 2 diabetes., Design: Emulation of a target trial., Setting: Medical and pharmacy claims data from the OptumLabs Data Warehouse, a de-identified US national dataset of beneficiaries of commercially insured and Medicare Advantage plans, 29 March 2013 to 30 June 2021., Participants: Adults (≥18 years) with type 2 diabetes who first started taking glimepiride, sitagliptin, liraglutide, insulin glargine, or canagliflozin between 29 March 2013 and 30 June 2021. Participants were treatment naive or were receiving metformin monotherapy at the time of starting the study drug., Main Outcome Measures: The main outcomes were time to primary and secondary metabolic failure of the assigned treatment, calculated as days to haemoglobin A 1c levels of ≥7.0% and >7.5%, respectively. Secondary metabolic, cardiovascular, and microvascular outcomes were analysed as specified in the GRADE statistical analysis plan. Propensity scores were estimated with the gradient boosting method, and inverse propensity score weighting was used to emulate randomisation to the treatment groups, which were then compared with Cox proportional hazards regression., Results: The study cohort included participants starting treatment with glimepiride (n=20 511), liraglutide (n=5569), sitagliptin (n=13 039), insulin glargine (n=7262), and canagliflozin (n=5290). The insulin glargine arm was excluded because of insufficient control of confounding. Median times to primary metabolic failure were 439 (95% confidence interval 400 to 489) days in the canagliflozin arm, 439 (426 to 453) days in the glimepiride arm, 624 (567 to 731) days in the liraglutide arm, and 461 (442 to 482) days in the sitagliptin arm. Median time to secondary metabolic failure was also longest in the liraglutide arm. Adults receiving liraglutide had the lowest one year cumulative incidence rate of primary metabolic failure (0.37, 95% confidence interval 0.35 to 0.40) followed by sitagliptin (0.44, 0.43 to 0.45), glimepiride (0.45, 0.44 to 0.45), and canagliflozin (0.46, 0.44 to 0.48). Similarly, the one year cumulative incidence rate of secondary metabolic failure was 0.27 (0.25 to 0.29) in the canagliflozin arm, 0.28 (0.27 to 0.29) in the glimepiride arm, 0.23 (0.21 to 0.26) in the liraglutide arm, and 0.28 (0.27 to 0.29) in the sitagliptin arm. No differences were observed between the study arms in the rates of microvascular and macrovascular complications., Conclusions: In this target trial emulation of an expanded GRADE study framework, liraglutide was more effective in achieving and maintaining glycaemic control as a second line glucose lowering drug than canagliflozin, sitagliptin, or glimepiride., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the National Institute of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), for the submitted work; RGM has received unrelated research support from NIDDK and the Patient-Centered Outcomes Research Institute (PCORI); RGM has also served as a consultant to Emmi on the development of patient education materials related to diabetes; JDW has received research support from the National Institute on Alcohol Abuse and Alcoholism of the NIH, the Food and Drug Administration (FDA), Johnson & Johnson, and the Collaboration for Research Integrity and Transparency (CRIT) at Yale University from the Arnold Ventures; JDW serves as a consultant for Hagens Berman Sobol Shapiro and Dugan Law Firm; JH works under contract to the Centers for Medicare and Medicaid Services on the development and evaluation of measures of provider quality; JH also receives research support from the National Institute on Aging, the National Cancer Institute, PCORI, the American Heart Association, and additional support from Yale University, Johnson & Johnson, and the Department of Defense; JSR currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the FDA for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) programme (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung, and Blood Institute of the NIH (R01HS025164, R01HL144644), and from Arnold Ventures; JSR was an expert witness at the request of relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled September 2022; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: Mortality from cardiovascular disease (CVD) varies across communities and is associated with known structural and population health factors. Still, a population's well-being, including sense of purpose, social relationships, financial security, and relationship to community, may be an important target to improve cardiovascular health., Objective: To examine the association of population level measures of well-being with rates of CVD mortality in the US., Design, Setting, and Participants: This cross-sectional study linked data from the Gallup National Health and Well-Being Index (WBI) survey to county-level rates of CVD mortality from the Centers for Disease Control and Prevention Atlas of Heart Disease and Stroke. Participants were respondents of the WBI survey, which was conducted by Gallup with randomly selected adults aged 18 years or older from 2015 to 2017. Data were analyzed from August 2022 to May 2023., Main Outcomes and Measures: The primary outcome was the county-level rate of total CVD mortality; secondary outcomes were mortality rates for stroke, heart failure, coronary heart disease, acute myocardial infarction, and total heart disease. The association of population well-being (measured using a modified version of the WBI) with CVD mortality was assessed, and an analysis of whether the association was modified by county structural factors (Area Deprivation Index [ADI], income inequality, and urbanicity) and population health factors (percentages of the adult population who had hypertension, diabetes, or obesity; were currently smoking; and were physically inactive) was conducted. Population WBI and its ability to mediate the association of structural factors associated with CVD using structural equation models was also assessed., Results: Well-being surveys were completed by 514 971 individuals (mean [SD] age 54.0 [19.2] years; 251 691 [48.9%] women; 379 521 [76.0%] White respondents) living in 3228 counties. Mortality rates for CVD decreased from a mean of 499.7 (range, 174.2-974.7) deaths per 100 000 persons in counties with the lowest quintile of population well-being to 438.6 (range, 110.1-850.4) deaths per 100 000 persons in counties with the highest quintile of population well-being. Secondary outcomes showed similar patterns. In the unadjusted model, the effect size (SE) of WBI on CVD mortality was -15.5 (1.5; P < .001), or a decrease of 15 deaths per 100 000 persons for each 1-point increase of population well-being. After adjusting for structural factors and structural plus population health factors, the association was attenuated but still significant, with an effect size (SE) of -7.3 (1.6; P < .001); for each 1-point increase in well-being, the total cardiovascular death rate decreased by 7.3 deaths per 100 000 persons. Secondary outcomes showed similar patterns, with mortality due to coronary heart disease and heart failure being significant in fully adjusted models. In mediation analyses, associations of income inequality and ADI with CVD mortality were all partly mediated by the modified population WBI., Conclusions and Relevance: In this cross-sectional study assessing the association of well-being and cardiovascular outcomes, higher well-being, a measurable, modifiable, and meaningful outcome, was associated with lower CVD mortality, even after controlling for structural and cardiovascular-related population health factors, indicating that well-being may be a focus for advancing cardiovascular health.

Importance: Amid efforts in the US to promote health equity, there is a need to assess recent progress in reducing excess deaths and years of potential life lost among the Black population compared with the White population., Objective: To evaluate trends in excess mortality and years of potential life lost among the Black population compared with the White population., Design, Setting, and Participants: Serial cross-sectional study using US national data from the Centers for Disease Control and Prevention from 1999 through 2020. We included data from non-Hispanic White and non-Hispanic Black populations across all age groups., Exposures: Race as documented in the death certificates., Main Outcomes and Measures: Excess age-adjusted all-cause mortality, cause-specific mortality, age-specific mortality, and years of potential life lost rates (per 100 000 individuals) among the Black population compared with the White population., Results: From 1999 to 2011, the age-adjusted excess mortality rate declined from 404 to 211 excess deaths per 100 000 individuals among Black males (P for trend <.001). However, the rate plateaued from 2011 through 2019 (P for trend = .98) and increased in 2020 to 395-rates not seen since 2000. Among Black females, the rate declined from 224 excess deaths per 100 000 individuals in 1999 to 87 in 2015 (P for trend <.001). There was no significant change between 2016 and 2019 (P for trend = .71) and in 2020 rates increased to 192-levels not seen since 2005. The trends in rates of excess years of potential life lost followed a similar pattern. From 1999 to 2020, the disproportionately higher mortality rates in Black males and females resulted in 997 623 and 628 464 excess deaths, respectively, representing a loss of more than 80 million years of life. Heart disease had the highest excess mortality rates, and the excess years of potential life lost rates were largest among infants and middle-aged adults., Conclusions and Relevance: Over a recent 22-year period, the Black population in the US experienced more than 1.63 million excess deaths and more than 80 million excess years of life lost when compared with the White population. After a period of progress in reducing disparities, improvements stalled, and differences between the Black population and the White population worsened in 2020.

Objectives: To examine the prevalence, severity, and co-occurrence of SPPADE symptoms as well as their association with cancer type and patient characteristics., Background: The SPPADE symptoms (sleep disturbance, pain, physical function impairment, anxiety, depression, and low energy /fatigue) are prevalent, co-occurring, and undertreated in oncology and other clinical populations., Methods: Baseline SPPADE symptom data were analyzed from the E2C2 study, a stepped wedge pragmatic, population-level, cluster randomized clinical trial designed to evaluate a guideline-informed symptom management model targeting the six SPPADE symptoms. Symptom prevalence and severity were measured with a 0-10 numeric rating (NRS) scale for each of the six symptoms. Prevalence of severe (NRS ≥ 7) and potential clinically relevant (NRS ≥ 5) symptoms as well as co-occurrence of clinical symptoms were determined. Distribution-based methods were used to estimate the minimally important difference (MID). Associations of cancer type and patient characteristics with a SPPADE composite score were analyzed., Results: A total of 31,886 patients were assessed for SPPADE symptoms prior to, during, or soon after an outpatient medical oncology encounter. The proportion of patients with a potential clinically relevant symptom ranged from 17.5% for depression to 33.4% for fatigue. Co-occurrence of symptoms was high, with the proportion of patients with three or more additional clinically relevant symptoms ranging from 45.2% for fatigue to 68.6% for depression. The summed SPPADE composite score demonstrated good internal reliability (Cronbach's alpha of 0.86), with preliminary MID estimates of 4.1-4.3. Symptom burden differed across several types of cancer but was generally similar across most sociodemographic characteristics., Conclusion: The high prevalence and co-occurrence of SPPADE symptoms in patients with all types of cancer warrants clinical approaches that optimize detection and management., (Copyright © 2023 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: Nonexercise algorithms are cost-effective methods to estimate cardiorespiratory fitness (CRF), but the existing models have limitations in generalizability and predictive power. This study aims to improve the nonexercise algorithms using machine learning (ML) methods and data from US national population surveys., Materials and Methods: We used the 1999-2004 data from the National Health and Nutrition Examination Survey (NHANES). Maximal oxygen uptake (VO2 max), measured through a submaximal exercise test, served as the gold standard measure for CRF in this study. We applied multiple ML algorithms to build 2 models: a parsimonious model using commonly available interview and examination data, and an extended model additionally incorporating variables from Dual-Energy X-ray Absorptiometry (DEXA) and standard laboratory tests in clinical practice. Key predictors were identified using Shapley additive explanation (SHAP)., Results: Among the 5668 NHANES participants in the study population, 49.9% were women and the mean (SD) age was 32.5 years (10.0). The light gradient boosting machine (LightGBM) had the best performance across multiple types of supervised ML algorithms. Compared with the best existing nonexercise algorithms that could be applied to the NHANES, the parsimonious LightGBM model (RMSE: 8.51 ml/kg/min [95% CI: 7.73-9.33]) and the extended LightGBM model (RMSE: 8.26 ml/kg/min [95% CI: 7.44-9.09]) significantly reduced the error by 15% and 12% (P < .001 for both), respectively., Discussion: The integration of ML and national data source presents a novel approach for estimating cardiovascular fitness. This method provides valuable insights for cardiovascular disease risk classification and clinical decision-making, ultimately leading to improved health outcomes., Conclusion: Our nonexercise models provide improved accuracy in estimating VO2 max within NHANES data as compared to existing nonexercise algorithms., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Importance: Adjusting quality measures used in pay-for-performance programs for social risk factors remains controversial., Objective: To illustrate a structured, transparent approach to decision-making about adjustment for social risk factors for a measure of clinician quality that assesses acute admissions for patients with multiple chronic conditions (MCCs)., Design, Setting, and Participants: This retrospective cohort study used 2017 and 2018 Medicare administrative claims and enrollment data, 2013 to 2017 American Community Survey data, and 2018 and 2019 Area Health Resource Files. Patients were Medicare fee-for-service beneficiaries 65 years or older with at least 2 of 9 chronic conditions (acute myocardial infarction, Alzheimer disease/dementia, atrial fibrillation, chronic kidney disease, chronic obstructive pulmonary disease or asthma, depression, diabetes, heart failure, and stroke/transient ischemic attack). Patients were attributed to clinicians in the Merit-Based Incentive Payment System (MIPS; primary health care professionals or specialists) using a visit-based attribution algorithm. Analyses were conducted between September 30, 2017, and August 30, 2020., Exposures: Social risk factors included low Agency for Healthcare Research and Quality Socioeconomic Status Index, low physician-specialist density, and Medicare-Medicaid dual eligibility., Main Outcomes and Measures: Number of acute unplanned hospital admissions per 100 person-years at risk for admission. Measure scores were calculated for MIPS clinicians with at least 18 patients with MCCs assigned to them., Results: There were 4 659 922 patients with MCCs (mean [SD] age, 79.0 [8.0] years; 42.5% male) assigned to 58 435 MIPS clinicians. The median (IQR) risk-standardized measure score was 38.9 (34.9-43.6) per 100 person-years. Social risk factors of low Agency for Healthcare Research and Quality Socioeconomic Status Index, low physician-specialist density, and Medicare-Medicaid dual eligibility were significantly associated with the risk of hospitalization in the univariate models (relative risk [RR], 1.14 [95% CI, 1.13-1.14], RR, 1.05 [95% CI, 1.04-1.06], and RR, 1.44 [95% CI, 1.43-1.45], respectively), but the association was attenuated in adjusted models (RR, 1.11 [95% CI 1.11-1.12] for dual eligibility). Across MIPS clinicians caring for variable proportions of dual-eligible patients with MCCs (quartile 1, 0%-3.1%; quartile 2, >3.1%-9.5%; quartile 3, >9.5%-24.5%, and quartile 4, >24.5%-100%), median measure scores per quartile were 37.4, 38.6, 40.0, and 39.8 per 100 person-years, respectively. Balancing conceptual considerations, empirical findings, programmatic structure, and stakeholder input, the Centers for Medicare & Medicaid Services decided to adjust the final model for the 2 area-level social risk factors but not dual Medicare-Medicaid eligibility., Conclusions and Relevance: This cohort study demonstrated that adjustment for social risk factors in outcome measures requires weighing high-stake, competing concerns. A structured approach that includes evaluation of conceptual and contextual factors, as well as empirical findings, with active engagement of stakeholders can be used to make decisions about social risk factor adjustment.

Estimated all-cause mortality within 30-days of hypoglycemic emergencies is 0.8 % in adults with type 1 diabetes and 1.7 % with type 2 diabetes; and within 30-days of hyperglycemic emergencies, it is 1.2 % with type 1 diabetes and 2.8 % with type 2 diabetes. These rates changed little between 2011 and 2020., Competing Interests: Declaration of Competing Interest In the past 36 months, Dr. McCoy received support from NIDDK, PCORI, and AARP® for research unrelated to this work. She also serves as a consultant to Emmi® (Wolters Kluwer) on the development of patient education materials related to prediabetes and diabetes. Dr. Galindo received research support to Emory University for investigator-initiated studies outside of this work from Novo Nordisk, Dexcom and Eli Lilly and consulting fees from Sanofi, Eli Lilly, Pfizer, Boehringer, and Weight Watchers. He is also funded by NIDDK. Dr. Umpierrez is partly supported by research grants from the Clinical and Translational Science Award program and NIDDK and has received research support (to Emory University) unrelated to this work from Astra Zeneca, Bayer, Abbott, and Dexcom. Dr. O’Connor has received research support from NIDDK, NHLBI, NCI, NICHD, NIMH, NIDA, and PCORI and has served as an unpaid consultant to the World Health Organization. Dr. Golden has received research support from NIDDK and serves on the Health Equity Advisory for Medtronic, Inc, and for Abbott., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Objective: To propose and evaluate a novel approach for measuring hospital-level disparities according to the effect of a continuous, polysocial risk factor on those outcomes., Study Setting: Our cohort consisted of Medicare Fee-for-Service (FFS) patients 65 years and older admitted to acute care hospitals for one of six common conditions or procedures. Medicare administrative claims data for six hospital readmission measures including hospitalizations from July 2015 to June 2018 were used., Study Design: We adapted existing methodologies that were developed to report hospital-level disparities using dichotomous social risk factors (SRFs). The existing methods report disparities within and across hospitals; we developed and tested modified approaches for both methods using the Agency for Healthcare Research and Quality Socioeconomic Status Index. We applied the adapted methodologies to six 30-day hospital readmission measures included in the Centers for Medicare & Medicaid Services Hospital Readmissions Reduction Program measures. We compared the within- and across-hospital results for each to those obtained from using the original methods and dichotomizing the AHRQ SES Index into "low" and "high" scores., Data Collection: We used Medicare FFS administrative claims data linked to U.S. Census data., Principal Findings: For all six readmission measures we find that, when compared with the existing methods, the methods for continuous SRFs provide disparity results for more facilities though across a narrower range of values. Measures of disparity based on this approach are moderately to highly correlated with those based on a dichotomous version of the same risk factor, while reflecting a fuller spectrum of risk. This approach represents an opportunity for detection of provider-level results that more closely align with underlying social risk., Conclusion: We have demonstrated the feasibility and utility of estimating hospital disparities of care using a continuous, polysocial risk factor. This approach expands the potential for reporting hospital-level disparities while better accounting for the multifactorial nature of social risk on hospital outcomes., (© 2022 Health Research and Educational Trust. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

We previously described the hypotheses, outcomes, design, and analysis for E2C2, a pragmatic stepped-wedge trial to assess an intervention to improve symptom control in patients with cancer. Subsequent consideration of the design and cohort led to the addition of a second primary hypothesis. This article describes and presents the rationale for this second hypothesis. This addendum also details a revised analytic approach, necessitated by inconsistencies in the original analytic plan. The design, outcomes, and other aspects of the protocol remain unchanged., (© 2023. The Author(s).)

Importance: Optimal diabetes care requires regular monitoring and care to maintain glycemic control. How high-deductible health plans (HDHPs), which reduce overall spending but may impede care by increasing out-of-pocket expenses, are associated with risks of severe hypoglycemia and hyperglycemia is unknown., Objective: To examine the association between an employer-forced switch to HDHP and severe hypoglycemia and hyperglycemia., Design, Setting, and Participants: This retrospective cohort study used deidentified administrative claims data for privately insured adults with diabetes from a single insurance carrier with multiple plans across the US between January 1, 2010, and December 31, 2018. Analyses were conducted between May 15, 2020, and November 3, 2022., Exposures: Patients with 1 baseline year of enrollment in a non-HDHP whose employers subsequently forced a switch to an HDHP were compared with patients who did not switch., Main Outcomes and Measures: Mixed-effects logistic regression models were used to examine the association between switching to an HDHP and the odds of severe hypoglycemia and hyperglycemia (ascertained using diagnosis codes in emergency department [ED] visits and hospitalizations), adjusting for patient age, sex, race and ethnicity, region, income, comorbidities, glucose-lowering medications, baseline ED and hospital visits for hypoglycemia and hyperglycemia, and baseline deductible amount, and applying inverse propensity score weighting to account for potential treatment selection bias., Results: The study population was composed of 42 326 patients who switched to an HDHP (mean [SD] age: 52 [10] years, 19 752 [46.7%] women, 7375 [17.4%] Black, 5740 [13.6%] Hispanic, 26 572 [62.8%] non-Hispanic White) and 202 729 patients who did not switch (mean [SD] age, 53 [10] years, 89 828 [44.3%] women, 29 551 [14.6%] Black, 26 689 [13.2%] Hispanic, 130 843 [64.5%] non-Hispanic White). When comparing all study years, switching to an HDHP was not associated with increased odds of experiencing at least 1 hypoglycemia-related ED visit or hospitalization (OR, 1.01 [95% CI, 0.95-1.06]; P = .85), but each year of HDHP enrollment did increase these odds by 2% (OR, 1.02 [95% CI, 1.00-1.04]; P = .04). In contrast, switching to an HDHP did significantly increase the odds of experiencing at least 1 hyperglycemia-related ED visit or hospitalization (OR, 1.25 [95% CI, 1.11-1.42]; P < .001), with each year of HDHP enrollment increasing the odds by 5% (OR, 1.05 [95% CI, 1.01-1.09]; P = .02)., Conclusions and Relevance: In this cohort study, employer-forced switching to an HDHP was associated with increased odds of potentially preventable acute diabetes complications, potentially because of delayed or deferred care. These findings suggest that employers should be more judicious in their health plan offerings, and health plans and policy makers should consider allowing preventive and high-value services to be exempt from deductible requirements.

The Centers for Medicare and Medicaid Services has been reporting hospital star ratings since 2016. Some stakeholders have criticized the star ratings methodology for not adjusting for social risk factors. We examined the relationship between 2021 star rating scores and hospitals' proportion of Medicare patients dually eligible for Medicaid. We found that, on average, hospitals caring for a greater proportion of dually eligible patients had lower star ratings, but there was significant overlap in performance among hospitals when we stratified them by quintile of dually eligible patients. Hospitals in the highest quintile (those with the greatest proportion of dually eligible patients) had the best mean mortality scores (0.28) but the worst readmission (-0.44) and patient experience (-0.78) scores. We assigned star ratings after stratifying the readmission measure group by proportion of dually eligible patients and found that a total of 142 hospitals gained a star and 161 hospitals lost a star, of which 126 (89 percent) and 1 (<1 percent) were in the highest quintile, respectively. Adjusting public reporting tools such as star ratings for social risk factors is ultimately a policy decision, and views on the appropriateness of accounting for factors such as proportion of dually eligible patients are mixed, depending on the organization and stakeholder.

Importance: Racial and ethnic disparities in delayed medical care for reasons that are not directly associated with the cost of care remain understudied., Objective: To describe trends in racial and ethnic disparities in barriers to timely medical care among adults during a recent 20-year period., Design, Setting, and Participants: This was a serial cross-sectional study of 590 603 noninstitutionalized adults in the US using data from the National Health Interview Survey from 1999 to 2018. Data analyses were performed from December 2021 through August 2022., Exposures: Self-reported race, ethnicity, household income, and sex., Main Outcomes and Measures: Temporal trends in disparities regarding 5 specific barriers to timely medical care: inability to get through by telephone, no appointment available soon enough, long waiting times, inconvenient office or clinic hours, and lack of transportation., Results: The study cohort comprised 590 603 adult respondents (mean [SE] age, 46.00 [0.07] years; 329 638 [51.9%] female; 27 447 [4.7%] Asian, 83 929 [11.8%] Black, 98 692 [13.8%] Hispanic/Latino, and 380 535 [69.7%] White). In 1999, the proportion of each race and ethnicity group reporting any of the 5 barriers to timely medical care was 7.3% among the Asian group; 6.9%, Black; 7.9%, Hispanic/Latino; and 7.0%, White (P > .05 for each difference compared with White individuals). From 1999 to 2018, this proportion increased across all 4 race and ethnicity groups (by 5.7, 8.0, 8.1, and 5.9 percentage points [pp] among Asian, Black, Hispanic/Latino, and White individuals, respectively; P < .001 for each), slightly increasing the disparities between groups. In 2018, compared with White individuals, the proportion reporting any barrier was 2.1 and 3.1 pp higher among Black and Hispanic/Latino individuals (P = .03 and P = .001, respectively). There was no significant difference in prevalence between Asian and White individuals. There was a significant increase in the difference in prevalence between Black individuals and White individuals who reported delaying care because of long waiting times at the clinic or medical office and because of a lack of transportation (1.5 pp and 1.8 pp; P = .03 and P = .01, respectively). In addition, the difference in prevalence between Hispanic/Latino and White individuals who reported delaying care because of long waiting times increased significantly (2.6 pp; P < .001)., Conclusions and Relevance: The findings of this serial cross-sectional study of data from the National Health Interview Survey suggest that barriers to timely medical care in the US increased for all population groups from 1999 to 2018, with associated increases in disparities among race and ethnicity groups. Interventions beyond those currently implemented are needed to improve access to medical care and to eliminate disparities among race and ethnicity groups.

Background/Aims: Clinical trials evaluating facility-to-facility telemedicine may include sites that have limited research experience. For the trial to be successful, these sites must correctly perform research-related tasks. This study aimed to determine whether health care professionals at community hospitals could accurately identify simulated study eligible patients and submit data to a research coordinating center. Methods: Twenty-seven community hospitals in the United States and Canada participated in this study. An electronic survey was sent to one designated health care professional at each site. The survey included a description of trial eligibility criteria and five written neonatal resuscitation scenarios. For each scenario, the participant determined whether the neonate was study eligible. One scenario required participants to submit 14 data elements to the coordinating center. Accuracy of study eligibility and data submission was summarized using standard descriptive statistics. Results: The survey response rate was 100% (27/27). Overall accuracy in determining study eligibility was 89% (120/135), and accuracy varied across the five scenarios (range 82-93%). Overall accuracy of data submission was 92% (310/336). Data were >95% accurate for 9 of the 14 data elements, with 100% accuracy achieved for 6 data elements. These results were used to clarify eligibility criteria, inform database design, and improve training materials for the subsequent clinical trial. Conclusions: Health care professionals at community hospitals accurately determined trial eligibility and submitted study data based on written clinical scenarios. Research teams conducting telemedicine trials with community hospitals should consider completing pre-trial simulation activities to identify opportunities for improving trial processes and materials.

Background: Disparities in multimorbidity prevalence indicate health inequalities, as the risk of morbidity does not intrinsically differ by race/ethnicity. This study aimed to determine if multimorbidity differences by race/ethnicity are decreasing over time., Methods: Serial cross-sectional analysis of the National Health Interview Survey, 1999-2018. Included individuals were ≥18 years old and categorized by self-reported race, ethnicity, age, and income. The main outcomes were temporal trends in multimorbidity prevalence based on the self-reported presence of ≥2 of 9 common chronic conditions., Findings: The study sample included 596,355 individuals (4.7% Asian, 11.8% Black, 13.8% Latino/Hispanic, and 69.7% White). In 1999, the estimated prevalence of multimorbidity was 5.9% among Asian, 17.4% among Black, 10.7% among Latino/Hispanic, and 13.5% among White individuals. Prevalence increased for all racial/ethnic groups during the study period (P ≤ .001 for each), with no significant change in the differences between them. In 2018, compared with White individuals, multimorbidity was more prevalent among Black individuals (+2.5 percentage points) and less prevalent among Asian and Latino/Hispanic individuals (-6.6 and -2.1 percentage points, respectively). Among those aged ≥30 years, Black individuals had multimorbidity prevalence equivalent to that of Latino/Hispanic and White individuals aged 5 years older, and Asian individuals aged 10 years older., Conclusions: From 1999 to 2018, a period of increasing multimorbidity prevalence for all the groups studied, there was no significant progress in eliminating disparities between Black individuals and White individuals. Public health interventions that prevent the onset of chronic conditions in early life may be needed to eliminate these disparities., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Importance: The ThermoCool SmartTouch catheter (ablation catheter with contact force and 6-hole irrigation [CF-I6]) is approved by the US Food and Drug Administration (FDA) for paroxysmal atrial fibrillation (AF) ablation and used in routine clinical practice for persistent AF ablation, although clinical outcomes for this indication are unknown. There is a need to understand whether data from routine clinical practice can be used to conduct regulatory-grade evaluations and support label expansions., Objective: To use health system data to compare the safety and effectiveness of the CF-I6 catheter for persistent AF ablation with the ThermoCool SmartTouch SurroundFlow catheter (ablation catheter with contact force and 56-hole irrigation [CF-I56]), which is approved by the FDA for this indication., Design, Setting, and Participants: This retrospective, comparative-effectiveness cohort study included patients undergoing catheter ablation for persistent AF at Mercy Health or Mayo Clinic from January 1, 2014, to April 30, 2021, with up to a 1-year follow-up using electronic health record data., Exposures: Use of the CF-I6 or CF-I56 catheter., Main Outcomes and Measures: The primary safety outcome was a composite of death, thromboembolic events, and procedural complications within 7 to 90 days. The exploratory effectiveness outcome was a composite of AF-related hospitalization events after a 90-day blanking period. Propensity score weighting was used to balance baseline covariates. Risk differences were estimated between catheter groups and averaged across the 2 health care systems, testing for noninferiority of the CF-I6 vs the CF-I56 catheter with respect to the safety outcome using 2-sided 90% CIs., Results: Overall, 1450 patients (1034 [71.3%] male; 1397 [96.3%] White) underwent catheter ablation for persistent AF, including 949 at Mercy Health (186 CF-I6 and 763 CF-I56; mean [SD] age, 64.9 [9.2] years) and 501 at Mayo Clinic (337 CF-I6 and 164 CF-I56; mean [SD] age, 63.7 [9.5] years). A total of 798 (55.0%) had been treated with class I or III antiarrhythmic drugs before ablation. The safety outcome (CF-I6 - CF-I56) was similar at both Mercy Health (1.3%; 90% CI, -2.1% to 4.6%) and Mayo Clinic (-3.8%; 90% CI, -11.4% to 3.7%); the mean difference was noninferior, with a mean of 0.5% (90% CI, -2.6% to 3.5%; P < .001). The effectiveness was similar at 12 months between the 2 catheter groups (mean risk difference, -1.8%; 90% CI, -7.3% to 3.7%)., Conclusions and Relevance: In this cohort study, the CF-I6 catheter met the prespecified noninferiority safety criterion for persistent AF ablation compared with the CF-I56 catheter, and effectiveness was similar. This study demonstrates the ability of electronic health care system data to enable safety and effectiveness evaluations of medical devices.

Background: Personalized treatment for clinical T1 renal cortical masses (RCMs) should take into account competing risks related to tumor and patient characteristics., Objective: To develop treatment-specific prediction models for cancer-specific mortality (CSM), other-cause mortality (OCM), and 90-d Clavien grade ≥3 complications across radical nephrectomy (RN), partial nephrectomy (PN), thermal ablation (TA), and active surveillance (AS)., Design, Setting, and Participants: Pretreatment clinical and radiological features were collected for consecutive adult patients treated with initial RN, PN, TA, or AS for RCMs at four high-volume referral centers (2000-2019)., Outcome Measurements and Statistical Analysis: Prediction models used competing-risks regression for CSM and OCM and logistic regression for 90-d Clavien grade ≥3 complications. Performance was assessed using bootstrap validation., Results and Limitations: The cohort comprised 5300 patients treated with RN (n = 1277), PN (n = 2967), TA (n = 476), or AS (n = 580). Over median follow-up of 5.2 yr (interquartile range 2.5-8.7), there were 117 CSM, 607 OCM, and 198 complication events. The C index for the predictive models was 0.80 for CSM, 0.77 for OCM, and 0.64 for complications. Predictions from the fitted models are provided in an online calculator (https://small-renal-mass-risk-calculator.fredhutch.org). To illustrate, a hypothetical 74-yr-old male with a 4.5-cm RCM, body mass index of 32 kg/m 2 , estimated glomerular filtration rate of 50 ml/min, Eastern Cooperative Oncology Group performance status of 3, and Charlson comorbidity index of 3 has predicted 5-yr CSM of 2.9-5.6% across treatments, but 5-yr OCM of 29% and risk of 90-d Clavien grade 3-5 complications of 1.9% for RN, 5.8% for PN, and 3.6% for TA. Limitations include selection bias, heterogeneity in practice across treatment sites and the study time period, and lack of control for surgeon/hospital volume., Conclusions: We present a risk calculator incorporating pretreatment features to estimate treatment-specific competing risks of mortality and complications for use during shared decision-making and personalized treatment selection for RCMs., Patient Summary: We present a risk calculator that generates personalized estimates of the risks of death from cancer or other causes and of complications for surgical, ablation, and surveillance treatment options for patients with stage 1 kidney tumors., (Copyright © 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Clinical decision support systems (CDSS) are low-cost, scalable tools with the potential to improve guideline-based antihypertensive treatment in primary care, but their effectiveness needs to be tested, especially in low- and middle-income countries such as China., Methods: The Learning Implementation of Guideline-based decision support system for Hypertension Treatment (LIGHT) trial is a pragmatic, four-stage, cluster-randomized trial conducted in 94 primary care sites in China. For each city-based stage, sites are randomly assigned to either implementation of the CDSS for hypertension management (which guides doctors' treatment recommendations based on measured blood pressure and patient characteristics), or usual care. Patients are enrolled during the first 3 months after site randomization and followed for 9 months. The primary outcome is the proportion of hypertension management visits at which guideline-based treatment is provided. In a nested trial conducted within the CDSS, with the patient as the unit of randomization, the LIGHT-ACD trial, patients are randomized to receive different initial mono- or dual-antihypertensive therapy. The primary outcome of the LIGHT-ACD trial is the changes in blood pressure., Discussion: The LIGHT trial will provide evidence on the effectiveness of a CDSS for improving guideline adherence for hypertension management in primary care in China. The nested trial, the LIGHT-ACD trial, will provide data on the effect of different initial antihypertensive regimens for blood pressure management in this setting., Trial Registration: ClinicalTrials.gov, identifier: LIGHT (NCT03636334) and LIGHT-ACD (NCT03587103). Registered on 3 July 2018., (© 2022. The Author(s).)

Importance: Historically marginalized racial and ethnic groups are generally more likely to experience sleep deficiencies. It is unclear how these sleep duration disparities have changed during recent years., Objective: To evaluate 15-year trends in racial and ethnic differences in self-reported sleep duration among adults in the US., Design, Setting, and Participants: This serial cross-sectional study used US population-based National Health Interview Survey data collected from 2004 to 2018. A total of 429 195 noninstitutionalized adults were included in the analysis, which was performed from July 26, 2021, to February 10, 2022., Exposures: Self-reported race, ethnicity, household income, and sex., Main Outcomes and Measures: Temporal trends and racial and ethnic differences in short (<7 hours in 24 hours) and long (>9 hours in 24 hours) sleep duration and racial and ethnic differences in the association between sleep duration and age., Results: The study sample consisted of 429 195 individuals (median [IQR] age, 46 [31-60] years; 51.7% women), of whom 5.1% identified as Asian, 11.8% identified as Black, 14.7% identified as Hispanic or Latino, and 68.5% identified as White. In 2004, the adjusted estimated prevalence of short and long sleep duration were 31.4% and 2.5%, respectively, among Asian individuals; 35.3% and 6.4%, respectively, among Black individuals; 27.0% and 4.6%, respectively, among Hispanic or Latino individuals; and 27.8% and 3.5%, respectively, among White individuals. During the study period, there was a significant increase in short sleep prevalence among Black (6.39 [95% CI, 3.32-9.46] percentage points), Hispanic or Latino (6.61 [95% CI, 4.03-9.20] percentage points), and White (3.22 [95% CI, 2.06-4.38] percentage points) individuals (P < .001 for each), whereas prevalence of long sleep changed significantly only among Hispanic or Latino individuals (-1.42 [95% CI, -2.52 to -0.32] percentage points; P = .01). In 2018, compared with White individuals, short sleep prevalence among Black and Hispanic or Latino individuals was higher by 10.68 (95% CI, 8.12-13.24; P < .001) and 2.44 (95% CI, 0.23-4.65; P = .03) percentage points, respectively, and long sleep prevalence was higher only among Black individuals (1.44 [95% CI, 0.39-2.48] percentage points; P = .007). The short sleep disparities were greatest among women and among those with middle or high household income. In addition, across age groups, Black individuals had a higher short and long sleep duration prevalence compared with White individuals of the same age., Conclusions and Relevance: The findings of this cross-sectional study suggest that from 2004 to 2018, the prevalence of short and long sleep duration was persistently higher among Black individuals in the US. The disparities in short sleep duration appear to be highest among women, individuals who had middle or high income, and young or middle-aged adults, which may be associated with health disparities.

Objectives: High-value care is providing high quality care at low cost; we sought to define hospital value and identify the characteristics of hospitals which provide high-value care., Design: Retrospective observational study., Setting: Acute care hospitals in the USA., Participants: All Medicare beneficiaries with claims included in Center for Medicare & Medicaid Services Overall Star Ratings or in publicly available Medicare spending per beneficiary data., Primary and Secondary Outcome Measures: Our primary outcome was value defined as the difference between Star Ratings quality score and Medicare spending; the secondary outcome was classification as a 4 or 5 star hospital with lowest quintile Medicare spending ('high value') or 1 or 2 star hospital with highest quintile spending ('low value')., Results: Two thousand nine hundred and fourteen hospitals had both quality and spending data, and were included. The value score had a mean (SD) of 0.58 (1.79). A total of 286 hospitals were classified as high value; these represented 28.6% of 999 4 and 5 star hospitals and 46.8% of 611 low cost hospitals. A total of 258 hospitals were classified as low value; these represented 26.6% of 970 1 and 2 star hospitals and 49.3% of 523 high cost hospitals. In regression models ownership, non-teaching status, beds, urbanity, nurse to bed ratio, percentage of dual eligible Medicare patients and percentage of disproportionate share hospital payments were associated with the primary value score., Conclusions: There are high quality hospitals that are not high value, and a number of factors are strongly associated with being low or high value. These findings can inform efforts of policymakers and hospitals to increase the value of care., Competing Interests: Competing interests: SMB, JH, ZL and AKV recieve salary support from the Centers for Medicare and Medicaid Services to develop, implement and maintain hospital performance outcome measures, including the methodology for the Overall Hospital Star Ratings, that are publicly reported. LIH and HY have worked under contract to the Centers for Medicare and Medicaid Services to develop quality measures, including some used in the Overall Hospital Star Ratings program., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Despite no proven benefit in clinical outcomes, perioperative magnetic resonance imaging (MRI) was rapidly adopted into breast cancer care in the 2000's, offering a prime opportunity for assessing factors influencing overutilization of unproven technology., Objectives: To examine variation among physician patient-sharing networks in their trajectory of adopting perioperative MRI for breast cancer surgery and compare the characteristics of patients, providers, and mastectomy use in physician networks that had different adoption trajectories., Methods and Findings: Using the Surveillance, Epidemiology, and End Results-Medicare database in 2004-2009, we identified 147 physician patient-sharing networks (caring for 26,886 patients with stage I-III breast cancer). After adjusting for patient clinical risk factors, we calculated risk-adjusted rate of perioperative MRI use for each physician network in 2004-2005, 2006-2007, and 2008-2009, respectively. Based on the risk-adjusted rate, we identified three distinct trajectories of adopting perioperative MRI among physician networks: 1) low adoption (risk-adjusted rate of perioperative MRI increased from 2.8% in 2004-2005 to 14.8% in 2008-2009), 2) medium adoption (8.8% to 45.1%), and 3) high adoption (33.0% to 71.7%). Physician networks in the higher adoption trajectory tended to have a larger proportion of cancer specialists, more patients with high income, and fewer patients who were Black. After adjusting for patients' clinical risk factors, the proportion of patients undergoing mastectomy decreased from 41.1% in 2004-2005 to 38.5% in 2008-2009 among those in physician networks with low MRI adoption, but increased from 27.0% to 31.4% among those in physician networks with high MRI adoption (p = 0.03 for the interaction term between trajectory group and time)., Conclusions: Physician patient-sharing networks varied in their trajectory of adopting perioperative MRI. These distinct trajectories were associated with the composition of patients and providers in the networks, and had important implications for patterns of mastectomy use., Competing Interests: Xiao Xu has received research support through Yale University from the Centers for Medicare and Medicaid Services to develop and maintain performance measures. Pamela R. Soulos reports consulting fees from TARGET PharmaSolutions, Inc. Jeph Herrin has ongoing research support through Yale University from the Centers for Medicare and Medicaid Services to develop and maintain performance measures and receives additional support for unrelated research from the Mayo Clinic, Johnson & Johnson, and Delta Airlines. Craig Evan Pollack reports stock ownership in Gilead Pharmaceuticals. In September 2019, Johns Hopkins University entered into a contract with the Department of Housing and Urban Development (HUD) for Pollack to work part time on a temporary assignment, assisting the department on housing and health issues. The opinions expressed by the authors do not necessarily represent the policies of the Department of Housing and Urban Development or opinions of the other funders. Cary P. Gross has received grant funding for research distinct from this project from Johnson & Johnson, National Comprehensive Cancer Network (NCCN) Foundation (Astra-Zeneca), and Genentech. The other authors had no conflict of interest to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: The symptom burden associated with cancer and its treatment can negatively affect patients' quality of life and survival. Symptom-focused collaborative care model (CCM) interventions can improve outcomes, but only if patients engage with them. We assessed the receptivity of severely symptomatic oncology patients to a remote nurse-led CCM intervention., Methods: In a pragmatic, cluster-randomized, stepped-wedge trial conducted as part of the National Cancer Institute IMPACT Consortium (E2C2, NCT03892967), patients receiving cancer care were asked to rate their sleep disturbance, pain, anxiety, emotional distress, fatigue, and limitations in physical function. Patients reporting at least 1 severe symptom (≥7/10) were offered phone consultation with a nurse symptom care manager (RN SCM). Initially, patients had to "opt-in" to receive a call, but the protocol was later modified so they had to "opt-out" if they did not want a call. We assessed the impact of opt-in vs opt-out framing and patient characteristics on receptiveness to RN SCM calls. All statistical tests were 2-sided., Results: Of the 1204 symptom assessments (from 864 patients) on which at least 1 severe symptom was documented, 469 (39.0%) indicated receptivity to an RN SCM phone call. The opt-out period (odds ratio [OR] = 1.61, 95% confidence interval [CI] = 1.12 to 2.32, P = .01), receiving care at a tertiary care center (OR = 3.59, 95% CI = 2.18 to 5.91, P < .001), and having severe pain (OR = 1.80, 95% CI = 1.24 to 2.62, P = .002) were associated with statistically significantly greater willingness to receive a call., Conclusions: Many severely symptomatic patients were not receptive to an RN SCM phone call. Better understanding of reasons for refusal and strategies for improving patient receptivity are needed., (© The Author(s) 2021. Published by Oxford University Press.)

Objectives. To describe national- and county-level trends and variation in a novel measure of hope. Methods. Using data from the Gallup National Health and Well-Being Index (n = 2 766 728), we summarized the difference between anticipated life satisfaction (ALS) and current life satisfaction (CLS), measured by the Cantril Self-Anchoring Scale, for each year from 2008 to 2020 and by county over two 5-year periods in the United States. Results. Across all years, there was a significant positive trend in the difference between ALS and CLS for the nation ( P  = .024), which remained positive but not significant when we excluded 2020. Maintenance of ALS with a decrease in CLS drove the 2020 increase. From 2008-2012 to 2013-2017, 14.5% of counties with 300 or more responses (n = 599) experienced an increase in the difference of more than 1 SD, whereas 13.9% experienced a more than 1 SD decrease. Fifty-two counties experienced decreases in ALS and CLS. Conclusions. Responding to trends in the gap between ALS and CLS at national and local levels is essential for the collective well-being of our nation, especially as we navigate and emerge from crisis.

Background and Aims: We conducted a retrospective cohort study comparing the risk of serious infections between patients treated with tumor necrosis factor-a (TNFa) antagonists vs. vedolizumab in patients with inflammatory bowel diseases (IBD)., Methods: Using an administrative claims database, we identified patients with IBD who were new-users of either TNFa antagonists or vedolizumab between 2014-2018 and had insurance coverage for at least 1y before and after treatment initiation. We compared the risk of serious infections (infections requiring hospitalization) between patients treated with vedolizumab or TNFa antagonists using marginal structural Cox proportional hazard models adjusted for baseline disease characteristics, healthcare utilization, comorbidities, and time-varying use of corticosteroids, immunomodulators and opiates., Results: We included 4881 patients treated with TNFa antagonists (age, 41 ± 15y, 60% with Crohn's disease [CD]) of whom 434 developed serious infections over 5786 person-year [PY] follow-up, and 1106 patients treated with vedolizumab (age, 44 ± 16y, 39% with CD) of whom 86 developed serious infections over 1040-PY follow-up. Vedolizumab was associated with 46% lower risk of serious infections as compared with TNFa antagonists in patients with ulcerative colitis (HR,0.54 [95% CI,0.35-0.83), but no significant differences were observed in patients with CD (HR,1.30 [0.80-2.11]). Vedolizumab was associated with lower risk of extra-intestinal serious infections in patients with UC, but higher risk of gastrointestinal serious infections in patients with CD., Conclusions: In an observational study of patients with IBD, vedolizumab was associated with lower risk of serious infections as compared with TNFa antagonists, in patients with UC, but not in patients with CD., (Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the association between pharmaceutical industry payments to rheumatologists and their prescribing behaviors., Methods: A cross-sectional analysis was conducted of Medicare Part B Public Use File, Medicare Part D Public Use File, and Open Payments data for 2013 to 2015. Prescription drugs responsible for 80% of the total Medicare pharmaceutical expenditures in rheumatology were analyzed. We calculated the mean annual drug cost per beneficiary per year, the percentage of rheumatologists who received payments, and the median annual payment per physician per drug per year. Industry payments were categorized as food/beverage and consulting/compensation. Multivariable regression models were used to assess associations between industry payments and both prescribing patterns and prescription drug expenditures., Results: Of 4822 rheumatologists in the Medicare prescribing databases, 3729 received any payment from a pharmaceutical company during this time frame. Food/beverage payments were associated with an increased proportion of prescriptions for the related drugs (range, 1.5% to 4.5%) and an increased proportion of annual Medicare spending for the related drugs (range, 3% to 23%). For every $100 in food/beverage payments, the probability of prescribing increased (range, 1.5% to 14% for most drugs) and Medicare reimbursements increased (range, 6% to 44% for most drugs). Consulting/compensation payments were associated with an increased proportion of prescriptions (range, 1.2% to 1.6%) and an increased proportion of annual Medicare spending (range, 1% to 2%). For every $1000 in consulting/compensation payments, both the probability of prescribing increased (5% or less for most drugs) and Medicare reimbursements increased (less than 10% for most drugs)., Conclusion: Payments to rheumatologists by pharmaceutical companies are associated with increased probability of prescribing and Medicare spending., (Copyright © 2021 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Importance: Low-income older adults who are dually eligible (DE) for Medicare and Medicaid often experience worse outcomes following hospitalization. Among other federal policies aimed at improving health for DE patients, Medicare has recently begun reporting disparities in within-hospital readmissions. The degree to which disparities for DE patients are owing to differences in community-level factors or, conversely, are amenable to hospital quality improvement, remains heavily debated., Objective: To examine the extent to which within-hospital disparities in 30-day readmission rates for DE patients are ameliorated by state- and community-level factors., Design Setting and Participants: In this retrospective cohort study, Centers for Medicare & Medicaid Services (CMS) Disparity Methods were used to calculate within-hospital disparities in 30-day risk-adjusted readmission rates for DE vs non-DE patients in US hospitals participating in Medicare. All analyses were performed in February and March 2019. The study included Medicare patients (aged ≥65 years) hospitalized for acute myocardial infarction (AMI), heart failure (HF), or pneumonia in 2014 to 2017., Main Outcomes and Measures: Within-hospital disparities, as measured by the rate difference (RD) in 30-day readmission between DE vs non-DE patients following admission for AMI, HF, or pneumonia; variance across hospitals; and correlation of hospital RDs with and without adjustment for state Medicaid eligibility policies and community-level factors., Results: The final sample included 475 444 patients admitted for AMI, 898 395 for HF, and 1 214 282 for pneumonia, of whom 13.2%, 17.4%, and 23.0% were DE patients, respectively. Dually eligible patients had higher 30-day readmission rates relative to non-DE patients (RD >0) in 99.0% (AMI), 99.4% (HF), and 97.5% (pneumonia) of US hospitals. Across hospitals, the mean (IQR) RD between DE vs non-DE was 1.00% (0.87%-1.10%) for AMI, 0.82% (0.73%-0.96%) for HF, and 0.53% (0.37%-0.71%) for pneumonia. The mean (IQR) RD after adjustment for community-level factors was 0.87% (0.73%-0.97%) for AMI, 0.67% (0.57%-0.80%) for HF, and 0.42% (0.29%-0.57%) for pneumonia. Relative hospital rankings of corresponding within-hospital disparities before and after community-level adjustment were highly correlated (Pearson coefficient, 0.98)., Conclusions and Relevance: In this cohort study, within-hospital disparities in 30-day readmission for DE patients were modestly associated with differences in state Medicaid policies and community-level factors. This suggests that remaining variation in these disparities should be the focus of hospital efforts to improve the quality of care transitions at discharge for DE patients in efforts to advance equity., Competing Interests: Conflict of Interest Disclosures: Dr Silvestri is currently employed by NYC Health and Hospitals but completed this work at Yale University while supported in part through CTSA Grant Number TL1 TR001864 from the National Center for Advancing Translational Science (NCATS), a component of the National Institutes of Health (NIH). Drs Peltz, Lloren, Zhou S, Zhou G, Farietta, Herrin, Lin, and Bernheim, Ms Charania, and Mr Goutos completed this work while working as employees or consultants at Yale New Haven Health Services Corporation/Center for Outcomes Research & Evaluation (YNHHSC/CORE). This work was supported by the Centers for Medicare & Medicaid Services (CMS) under contract HHSM-500-2013-13018I/HHSM-500-T0001., (Copyright 2022 Silvestri D et al. JAMA Health Forum.)

Poor hypertension awareness and underuse of guideline-recommended medications are critical factors contributing to poor hypertension control. Using data from 8095 hypertensive people aged ≥18 years from the National Health and Nutrition Examination Survey (2011-2018), we examined recent trends in racial and ethnic differences in awareness and antihypertensive medication use, and their association with racial and ethnic differences in hypertension control. Between 2011 and 2018, age-adjusted hypertension awareness declined for Black, Hispanic, and White individuals, but the 3 outcomes increased or did not change for Asian individuals. Compared with White individuals, Black individuals had a similar awareness (odds ratio, 1.20 [0.96-1.45]) and overall treatment rates (1.04 [0.84-1.25]), and received more intensive antihypertensive medication if treated (1.41 [1.27-1.56]), but had a lower control rate (0.72 [0.61-0.83]). Asian and Hispanic individuals had significantly lower awareness rates (0.69 [0.52-0.85] and 0.74 [0.59-0.89]), overall treatment rates (0.72 [0.57-0.88] and 0.69 [0.55-0.82]), received less intensive medication if treated (0.60 [0.50-0.72] and 0.86 [0.75-0.96]), and had lower control rates (0.66 [0.54-0.79] and 0.69 [0.57-0.81]). The racial and ethnic differences in awareness, treatment, and control persisted over the study period and were consistent across age, sex, and income strata. Lower awareness and treatment were significantly associated with lower control in Asian and Hispanic individuals ( P <0.01 for all) but not in Black individuals. These findings highlight the need for interventions to improve awareness and treatment among Asian and Hispanic individuals, and more investigation into the downstream factors that may contribute to the poor hypertension control among Black individuals.