Age and Aspirin Dosing in Secondary Prevention of Atherosclerotic Cardiovascular Disease.

BACKGROUND: In patients with atherosclerotic cardiovascular disease, increasing age is concurrently associated with higher risks of ischemic and bleeding events. The objectives are to determine the impact of aspirin dose on clinical outcomes according to age in atherosclerotic cardiovascular disease. METHODS AND RESULTS: In the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) trial, patients with atherosclerotic cardiovascular disease were randomized to daily aspirin doses of 81 mg or 325 mg. The primary effectiveness end point was death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke. The primary safety end point was hospitalization for bleeding requiring transfusion. A total of 15 076 participants were randomized to aspirin 81 mg (n=7540) or 325 mg (n=7536) daily (median follow-up: 26.2 months; interquartile range: 19.0-34.9 months). Median age was 67.6 years (interquartile range: 60.7-73.6 years). Among participants aged <65 years (n=5841 [38.7%]), a primary end point occurred in 226 (7.54%) in the 81 mg group, and in 191 (6.80%) in the 325 mg group (adjusted hazard ratio [HR], 1.23 [95% CI, 1.01-1.49]). Among participants aged ≥65 years (n=9235 [61.3%]), a primary end point occurred in 364 (7.12%) in the 81 mg group, and in 378 (7.96%) in the 325 mg group (adjusted HR, 0.95 [95% CI, 0.82-1.10]). The age-dose interaction was not significant (P=0.559). There was no significant interaction between age and the randomized aspirin dose for the secondary effectiveness and the primary safety bleeding end points (P>0.05 for all). CONCLUSIONS: Age does not modify the impact of aspirin dosing (81 mg or 325 mg daily) on clinical end points in secondary prevention of atherosclerotic cardiovascular disease.

Incorporating Acute Conditions into Risk-Adjustment for Provider Profiling: The Case of the US News and World Report Best Hospitals Rankings Methodology.

Several years ago, the US News and World Report changed their risk-adjustment methodology, now relying almost exclusively on chronic conditions for risk adjustment. The impacts of adding selected acute conditions like pneumonia, sepsis, and electrolyte disorders ("augmented") to their current risk models ("base") for 4 specialties-cardiology, neurology, oncology, and pulmonology-on estimates of hospital performance are reported here. In the augmented models, many acute conditions were associated with substantial risks of mortality. Compared to the base models, the discrimination and calibration of the augmented models for all specialties were improved. While estimated hospital performance was highly correlated between the 2 models, the inclusion of acute conditions in risk-adjustment models meaningfully improved the predictive ability of those models and had noticeable effects on hospital performance estimates. Measures or conditions that address disease severity should always be included when risk-adjusting hospitalization outcomes, especially if the goal is provider profiling.

smdi: an R package to perform structural missing data investigations on partially observed confounders in real-world evidence studies.

Objectives: Partially observed confounder data pose a major challenge in statistical analyses aimed to inform causal inference using electronic health records (EHRs). While analytic approaches such as imputation are available, assumptions on underlying missingness patterns and mechanisms must be verified. We aimed to develop a toolkit to streamline missing data diagnostics to guide choice of analytic approaches based on meeting necessary assumptions. Materials and methods: We developed the smdi (structural missing data investigations) R package based on results of a previous simulation study which considered structural assumptions of common missing data mechanisms in EHR. Results: smdi enables users to run principled missing data investigations on partially observed confounders and implement functions to visualize, describe, and infer potential missingness patterns and mechanisms based on observed data. Conclusions: The smdi R package is freely available on CRAN and can provide valuable insights into underlying missingness patterns and mechanisms and thereby help improve the robustness of real-world evidence studies.

Correlations Between Relative Prevalence of Celiac Disease and Sociodemographic Variables in the United States.

INTRODUCTION: We evaluated the associations between celiac disease (CD) prevalence and regional sociodemographic variables in the United States. METHODS: The outcome was CD relative prevalence, defined as number of patients with CD among those in a Medicare registry per 3-digit ZIP code. Linear regression models assessed associations between relative prevalence of CD and sociodemographic variables. RESULTS: CD relative prevalence was positively correlated with median income, urban area, and proximity to a CD specialty center and negatively correlated with Black race, Latino/Hispanic ethnicity, and median social deprivation index score ( P < 0.01, all). DISCUSSION: CD relative prevalence is associated with indicators of economic advantage.

Linking Medicare-Medicaid Claims for Patient-Centered Outcomes Research Among Dual-Eligible Beneficiaries.

BACKGROUND: Evaluation of Medicare-Medicaid integration models' effects on patient-centered outcomes and costs requires multiple data sources and validated processes for linkage and reconciliation. OBJECTIVE: To describe the opportunities and limitations of linking state-specific Medicaid and Centers for Medicare & Medicaid Services administrative claims data to measure patient-centered outcomes for North Carolina dual-eligible beneficiaries. RESEARCH DESIGN: We developed systematic processes to (1) validate the beneficiary ID linkage using sex and date of birth in a beneficiary ID crosswalk, (2) verify dates of dual enrollment, and (3) reconcile Medicare-Medicaid claims data to support the development and use of patient-centered outcomes in linked data. PARTICIPANTS: North Carolina Medicaid beneficiaries with full Medicaid benefits and concurrent Medicare enrollment (FBDE) between 2014 and 2017. MEASURES: We identified need-based subgroups based on service use and eligibility program requirements. We calculated utilization and costs for Medicaid and Medicare, matched Medicaid claims to Medicare service categories where possible, and reported outcomes by the payer. Some services were covered only by Medicaid or Medicare, including Medicaid-only covered home and community-based services (HCBS). RESULTS: Of 498,030 potential dual enrollees, we verified the linkage and FBDE eligibility of 425,664 (85.5%) beneficiaries, including 281,174 adults enrolled in Medicaid and Medicare fee-for-service. The most common need-based subgroups were intensive behavioral health service users (26.2%) and HCBS users (10.8%) for adults under age 65, and HCBS users (20.6%) and nursing home residents (12.4%) for adults age 65 and over. Medicaid funded 42% and 49% of spending for adults under 65 and adults 65 and older, respectively. Adults under 65 had greater behavioral health service utilization but less skilled nursing facility, HCBS, and home health utilization compared with adults 65 and older. CONCLUSIONS: Linkage of Medicare-Medicaid data improves understanding of patient-centered outcomes among FBDE by combining Medicare-funded acute and ambulatory services with Medicaid-funded HCBS. Using linked Medicare-Medicaid data illustrates the diverse patient experience within FBDE beneficiaries, which is key to informing patient-centered outcomes, developing and evaluating integrated Medicare and Medicaid programs, and promoting health equity.

Optimizing data integration in trials that use EHR data: lessons learned from a multi-center randomized clinical trial.

BACKGROUND: Despite great promise, trials that ascertain patient clinical data from electronic health records (EHR), referred to here as "EHR-sourced" trials, are limited by uncertainty about how existing trial sites and infrastructure can be best used to operationalize study goals. Evidence is needed to support the practical use of EHRs in contemporary clinical trial settings. MAIN TEXT: We describe a demonstration project that used EHR data to complement data collected for a contemporary multi-center pharmaceutical industry outcomes trial, and how a central coordinating center supported participating sites through the technical, governance, and operational aspects of this type of activity. We discuss operational considerations related to site selection, data extraction, site performance, and data transfer and quality review, and we outline challenges and lessons learned. We surveyed potential sites and used their responses to assess feasibility, determine the potential capabilities of sites and choose an appropriate data extraction strategy. We designed a flexible, multimodal approach for data extraction, enabling each site to either leverage an existing data source, create a new research datamart, or send all data to the central coordinating center to produce the requisite data elements. We evaluated site performance, as reflected by the speed of contracting and IRB approval, total patients enrolled, enrollment yield, data quality, and compared performance by data collection strategy. CONCLUSION: While broadening the type of sites able to participate in EHR-sourced trials may lead to greater generalizability and improved enrollment, sites with fewer technical resources may require additional support to participate. Central coordinating center support is essential to facilitate the execution of operational processes. Future work should focus on sharing lessons learned and creating reusable tools to facilitate participation of heterogeneous trial sites.

Non-overdose acute care hospitalizations for opioid use disorder among commercially-insured adults: a retrospective cohort study.

BACKGROUND: Acute care inpatient admissions outside of psychiatric facilities have been increasingly identified as a critical touchpoint for opioid use disorder (OUD) treatment. We sought to describe non-opioid overdose hospitalizations with documented OUD and examine receipt of post-discharge outpatient buprenorphine. METHODS: We examined acute care hospitalizations with an OUD diagnosis in any position within US commercially-insured adults age 18-64 years (IBM MarketScan claims, 2013-2017), excluding opioid overdose diagnoses. We included individuals with ≥ 6 months of continuous enrollment prior to the index hospitalization and ≥ 10 days following discharge. We described demographic and hospitalization characteristics, including outpatient buprenorphine receipt within 10 days of discharge. RESULTS: Most (87%) hospitalizations with documented OUD did not include opioid overdose. Of 56,717 hospitalizations (49,959 individuals), 56.8% had a primary diagnosis other than OUD, 37.0% had documentation of an alcohol-related diagnosis code, and 5.8% end in a self-directed discharge. Where opioid use disorder was not the primary diagnosis, 36.5% were due to other substance use disorders, and 23.1% were due to psychiatric disorders. Of all non-overdose hospitalizations who had prescription medication insurance coverage and who were discharged to an outpatient setting (n = 49, 237), 8.8% filled an outpatient buprenorphine prescription within 10 days of discharge. CONCLUSIONS: Non-overdose OUD hospitalizations often occur with substance use disorders and psychiatric disorders, and very few are followed by timely outpatient buprenorphine. Addressing the OUD treatment gap during hospitalization may include implementing medication for OUD for inpatients with a broad range of diagnoses.

Neighborhood socioeconomic deprivation, healthcare access, and 30-day mortality and readmission after sepsis or critical illness: findings from a nationwide study.

BACKGROUND: To determine if neighborhood socioeconomic deprivation independently predicts 30-day mortality and readmission for patients with sepsis or critical illness after adjusting for individual poverty, demographics, comorbidity burden, access to healthcare, and characteristics of treating healthcare facilities. METHODS: We performed a nationwide study of United States Medicare beneficiaries from 2017 to 2019. We identified hospitalized patients with severe sepsis and patients requiring prolonged mechanical ventilation, tracheostomy, or extracorporeal membrane oxygenation (ECMO) through Diagnosis Related Groups (DRGs). We estimated the association between neighborhood socioeconomic deprivation, measured by the Area Deprivation Index (ADI), and 30-day mortality and unplanned readmission using logistic regression models with restricted cubic splines. We sequentially adjusted for demographics, individual poverty, and medical comorbidities, access to healthcare services; and characteristics of treating healthcare facilities. RESULTS: A total of 1,526,405 admissions were included in the mortality analysis and 1,354,548 were included in the readmission analysis. After full adjustment, 30-day mortality for patients was higher for those from most-deprived neighborhoods (ADI 100) compared to least deprived neighborhoods (ADI 1) for patients with severe sepsis (OR 1.35 95% [CI 1.29-1.42]) or with prolonged mechanical ventilation with or without sepsis (OR 1.42 [95% CI 1.31, 1.54]). This association was linear and dose dependent. However, neighborhood socioeconomic deprivation was not associated with 30-day unplanned readmission for patients with severe sepsis and was inversely associated with readmission for patients requiring prolonged mechanical ventilation with or without sepsis. CONCLUSIONS: A strong association between neighborhood socioeconomic deprivation and 30-day mortality for critically ill patients is not explained by differences in individual poverty, demographics, measured baseline medical risk, access to healthcare resources, or characteristics of treating hospitals.

Neighborhood Socioeconomic Disadvantage, Healthcare Access, and Outcomes of Hospitalizations for Common Pulmonary Conditions: A National Study of Medicare Beneficiaries.

Rationale: Understanding how systemic forces and environmental exposures impact patient outcomes is critical to advancing health equity and improving population health for patients with pulmonary disease. This relationship has not yet been assessed at the population level nationally. Objectives: To determine whether neighborhood socioeconomic deprivation is independently associated with 30-day mortality and readmission for hospitalized patients with pulmonary conditions, after controlling for demographics, access to healthcare resources, and characteristics of admitting healthcare facilities. Methods: This was a retrospective, population-level cohort study of 100% of United States nationwide Medicare inpatient and outpatient claims from 2016-2019. Patients were admitted for one of four pulmonary conditions (pulmonary infections, chronic lower respiratory disease, pulmonary embolism, and pleural and interstitial lung diseases), defined by diagnosis-related group. The primary exposure was neighborhood socioeconomic deprivation, measured by the area deprivation index. The main outcomes were 30-day mortality and 30-day unplanned readmission, defined by Centers for Medicare and Medicaid Services methodologies. Generalized estimating equations were used to estimate logistic regression models for the primary outcomes, addressing clustering by hospital. A sequential adjustment strategy was first adjusted for age, legal sex, Medicare-Medicaid dual eligibility, and comorbidity burden, then adjusted for metrics of access to healthcare resources, and finally adjusted for characteristics of the admitting healthcare facility. Results: After full adjustment, patients from low socioeconomic status neighborhoods had greater 30-day mortality after admission for pulmonary embolism (odds ratio [OR], 1.26; 95% confidence interval [CI], 1.13-1.40), respiratory infections (OR, 1.20; 95% CI, 1.16-1.25), chronic lower respiratory disease (OR, 1.31; 95% CI, 1.22-1.41), and interstitial lung disease (OR, 1.15; 95% CI, 1.04-1.27) when compared to patients from the highest SES neighborhoods. Low neighborhood socioeconomic status was also associated with 30-day readmission for all groups except the interstitial lung disease group. Conclusions: Neighborhood socioeconomic deprivation may be a key factor driving poor health outcomes for patients with pulmonary diseases.

Outcomes among patients with peripheral artery disease in the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study.

BACKGROUND: We aimed to understand the effects of aspirin dose on outcomes in patients with peripheral artery disease (PAD) as well as their participation in a pragmatic randomized controlled trial. METHODS: In a subanalysis of the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study, we compared aspirin doses (81 vs 325 mg) among participants with PAD and study participation metrics in patients with and without PAD. The primary outcome composite was all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke. RESULTS: Among 14,662 participants enrolled in ADAPTABLE with PAD status available, 3493 (23.8%) had PAD. Participants with PAD were more likely to experience the primary composite (13.76% vs 5.31%, p < 0.001), all-cause mortality (7.55% vs 3.01%, p < 0.001), myocardial infarction (5.71% vs 2.09%, p < 0.001), stroke (2.45% vs 0.86%, p < 0.001), and major bleeding (1.19% vs 0.44%, p < 0.001). A higher aspirin dose did not reduce the primary outcome in patients with PAD (13.68% vs 13.84% in 81 mg and 325 mg groups; OR 1.05, 95% CI 0.88-1.25). Participants with PAD were less likely to enroll via email (33.0% vs 41.9%, p < 0.0001), less likely to choose internet follow-up (79.2% vs 89.5%, p < 0.0001), and were more likely to change their aspirin doses (39.7% vs 30.7%, p < 0.0001). CONCLUSIONS: ADAPTABLE participants with PAD did not benefit from a higher dose of aspirin and participated in the study differently from those without PAD. These results reinforce the need for additional PAD-specific research and suggest that different trial strategies may be needed for optimal engagement of patients with PAD. (ClinicalTrials.gov Identifier: NCT02697916).

Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale.

Whether initiation of statins could increase survival free of dementia and disability in adults aged ≥75 years is unknown. PREVENTABLE, a double-blind, placebo-controlled randomized pragmatic clinical trial, will compare high-intensity statin therapy (atorvastatin 40 mg) with placebo in 20,000 community-dwelling adults aged ≥75 years without cardiovascular disease, disability, or dementia at baseline. Exclusion criteria include statin use in the prior year or for >5 years and inability to take a statin. Potential participants are identified using computable phenotypes derived from the electronic health record and local referrals from the community. Participants will undergo baseline cognitive testing, with physical testing and a blinded lipid panel if feasible. Cognitive testing and disability screening will be conducted annually. Multiple data sources will be queried for cardiovascular events, dementia, and disability; survival is site-reported and supplemented by a National Death Index search. The primary outcome is survival free of new dementia or persisting disability. Co-secondary outcomes are a composite of cardiovascular death, hospitalization for unstable angina or myocardial infarction, heart failure, stroke, or coronary revascularization; and a composite of mild cognitive impairment or dementia. Ancillary studies will offer mechanistic insights into the effects of statins on key outcomes. Biorepository samples are obtained and stored for future study. These results will inform the benefit of statins for increasing survival free of dementia and disability among older adults. This is a pioneering pragmatic study testing important questions with low participant burden to align with the needs of the growing population of older adults.

Association Between Neighborhood Socioeconomic Status and 30-Day Mortality and Readmission for Patients With Common Neurologic Conditions.

BACKGROUND AND OBJECTIVES: Patients of low individual socioeconomic status (SES) are at a greater risk of unfavorable health outcomes. However, the association between neighborhood socioeconomic deprivation and health outcomes for patients with neurologic disorders has not been studied at the population level. Our objective was to determine the association between neighborhood socioeconomic deprivation and 30-day mortality and readmission after hospitalization for various neurologic conditions. METHODS: This was a retrospective study of nationwide Medicare claims from 2017 to 2019. We included patients older than 65 years hospitalized for the following broad categories based on diagnosis-related groups (DRGs): multiple sclerosis and cerebellar ataxia (DRG 058-060); stroke (061-072); degenerative nervous system disorders (056-057); epilepsy (100-101); traumatic coma (082-087), and nontraumatic coma (080-081). The exposure of interest was neighborhood SES, measured by the area deprivation index (ADI), which uses socioeconomic indicators, such as educational attainment, unemployment, infrastructure access, and income, to estimate area-level socioeconomic deprivation at the level of census block groups. Patients were grouped into high, middle, and low neighborhood-level SES based on ADI percentiles. Adjustment covariates included age, comorbidity burden, race/ethnicity, individual SES, and sex. RESULTS: After exclusions, 905,784 patients were included in the mortality analysis and 915,993 were included in the readmission analysis. After adjustment for age, sex, race/ethnicity, comorbidity burden, and individual SES, patients from low SES neighborhoods had higher 30-day mortality rates compared with patients from high SES neighborhoods for all disease categories except for multiple sclerosis: magnitudes of the effect ranged from an adjusted odds ratio of 2.46 (95% CI 1.60-3.78) for the nontraumatic coma group to 1.23 (95% CI 1.19-1.28) for the stroke group. After adjustment, no significant differences in readmission rates were observed for any of the groups. DISCUSSION: Neighborhood SES is strongly associated with 30-day mortality for many common neurologic conditions even after accounting for baseline comorbidity burden and individual SES. Strategies to improve health equity should explicitly consider the effect of neighborhood environments on health outcomes.

Association Between Device Type and Type IIIb Endoleaks Following Thoracic Endovascular Aortic Repair.

OBJECTIVE: Endoleaks following thoracic endovascular aortic repair (TEVAR) can lead to the need for re-intervention and aortic rupture. Given the recent recall of a specific thoracic stent graft type due to concerns about type IIIb endoleak (T3bE), in which blood leaks through the stent graft fabric, the aim was to characterise patterns of T3bEs among available TEVAR devices. METHODS: Reports related to thoracic stent grafts in the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between 2010 and 2020 were reviewed. Proportional reporting ratios (PRRs) and chi squared tests were used to assess for the presence of a signal of association between device type and T3bE. A PRR > 2 and chi squared value > 4 with three or more reports overall constituted a signal of association. The institutional database of patients undergoing TEVAR for thoracic aneurysms since 2002 was also queried for T3bE. RESULTS: There were 7 328 MAUDE reports available for analysis. When analysing T3bEs in the MAUDE database, the lowest PRR was 0.36 (95% confidence interval [CI] 0 - 1.03 in Gore CTAG, nine T3bE among 1 328 reports) and the highest was 2.07 (95% CI 1.72 - 2.42 in Medtronic Valiant, 64 T3bE among 2 520 reports). The T3bE chi squared value for Medtronic Valiant was 17.3. The relationship between Medtronic Valiant and T3bE was ascertainable by MAUDE data as early as 2013. Among 542 TEVARs for an aneurysm indication at Duke University Hospital since 2002, there were eight T3bEs - all in devices with sutured on graft material. CONCLUSION: The Medtronic Valiant device met criteria for association with type IIIb endoleaks in the FDA's MAUDE database and met those criteria as early as 2013. A possible relationship between woven graft fabric and T3bEs is supported by the observation that all types of T3bE that occurred among a large number of TEVARs at the institution followed placement of grafts with sutured on woven fabric.

Concordance Between Patient-Reported Health Data and Electronic Health Data in the ADAPTABLE Trial.

Importance: Patient-reported health data can facilitate clinical event capture in pragmatic clinical trials. However, few data are available on the fitness for use of patient-reported data in large-scale health research. Objective: To evaluate the concordance of a set of variables reported by patients and available in the electronic health record as part of a pragmatic clinical trial. Design, Setting, and Participants: Data from ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness), a pragmatic clinical trial, were used in a concordance substudy of a comparative effectiveness research trial. The trial randomized 15 076 patients with existing atherosclerotic cardiovascular disease in a 1:1 ratio to low- or high-dose aspirin from April 2016 through June 30, 2019. Main Outcomes and Measures: Concordance of data was evaluated from 4 domains (demographic characteristics, encounters, diagnoses, and procedures) present in 2 data sources: patient-reported data captured through an online portal and data from electronic sources (electronic health record data). Overall agreement, sensitivity, specificity, positive predictive value, negative predictive value, and κ statistics with 95% CIs were calculated using patient report as the criterion standard for demographic characteristics and the electronic health record as the criterion standard for clinical outcomes. Results: Of 15 076 patients with complete information, the median age was 67.6 years (range, 21-99 years), and 68.7% were male. With the use of patient-reported data as the criterion standard, agreement (κ) was high for Black and White race and ethnicity but only moderate for current smoking status. Electronic health record data were highly specific (99.6%) but less sensitive (82.5%) for Hispanic ethnicity. Compared with electronic health record data, patient report of clinical end points had low sensitivity for myocardial infarction (33.0%), stroke (34.2%), and major bleeding (36.6%). Positive predictive value was similarly low for myocardial infarction (40.7%), stroke (38.8%), and major bleeding (21.9%). Coronary revascularization was the most concordant event by data source, with only moderate agreement (κ = 0.54) and positive predictive value. Agreement metrics varied by site for all demographic characteristics and several clinical events. Conclusions and Relevance: In a concordance substudy of a large, pragmatic comparative effectiveness research trial, sensitivity and chance-corrected agreement of patient-reported data captured through an online portal for cardiovascular events were low to moderate. Findings suggest that additional work is needed to optimize integration of patient-reported health data into pragmatic research studies. Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.

Healthcare Utilization for Medicaid-Insured Children with Medical Complexity: Differences by Sociodemographic Characteristics.

OBJECTIVE: To compare differences in healthcare utilization and costs for Medicaid-insured children with medical complexity (CMC) by race/ethnicity and rurality. METHODS: Retrospective cohort of North Carolina (NC) Medicaid claims for children 3-20 years old with 3 years continuous Medicaid coverage (10/1/2015-9/30/2018). Exposures were medical complexity, race/ethnicity, and rurality. Three medical complexity levels were: without chronic disease, non-complex chronic disease, and complex chronic disease; the latter were defined as CMC. Race/ethnicity was self-reported in claims; we defined rurality by home residence ZIP codes. Utilization and costs were summarized for 1 year (10/1/2018-9/30/2019) by complexity level classification and categorized as acute care (hospitalization, emergency [ED]), outpatient care (primary, specialty, allied health), and pharmacy. Per-complexity group utilization rates (per 1000 person-years) by race/ethnicity and rurality were compared using adjusted rate ratios (ARR). RESULTS: Among 859,166 Medicaid-insured children, 118,210 (13.8%) were CMC. Among CMC, 36% were categorized as Black non-Hispanic, 42.7% White non-Hispanic, 14.3% Hispanic, and 35% rural. Compared to White non-Hispanic CMC, Black non-Hispanic CMC had higher hospitalization (ARR = 1.12; confidence interval, CI 1.08-1.17) and ED visit (ARR = 1.17; CI 1.16-1.19) rates; Hispanic CMC had lower ED visit (ARR = 0.77; CI 0.75-0.78) and hospitalization rates (ARR = 0.79; CI 0.73-0.84). Black non-Hispanic and Hispanic CMC had lower outpatient visit rates than White non-Hispanic CMC. Rural CMC had higher ED (ARR = 1.13; CI 1.11-1.15) and lower primary care utilization rates (ARR = 0.87; CI 0.86-0.88) than urban CMC. DISCUSSION: Healthcare utilization varied by race/ethnicity and rurality for Medicaid-insured CMC. Further studies should investigate mechanisms for these variations and expand higher value, equitable care delivery for CMC.

Rates of Medicare Enrollment Among Dialysis Patients After Implementation of Medicare Payment Reform and the Affordable Care Act Marketplace.

Importance: Medicare finances health care for most US patients with end-stage kidney disease (ESKD), regardless of age. The 2011 Medicare prospective payment system (PPS) for dialysis reduced reimbursement for hemodialysis, and the 2014 Patient Protection and Affordable Care Act (ACA) Marketplace increased patient access to new private insurance options, potentially influencing organizations that provide health care, such as hospitals, nursing homes, and dialysis facilities, to adjust their payer mix away from Medicare sources. Objective: To describe Medicare enrollment trends among patients with incident ESKD in 2006 to 2016. Design, Setting, and Participants: This retrospective cohort study involved US patients aged 18 to 64 years who were not enrolled in Medicare at dialysis initiation in 2006 to 2016, with 1-year follow-up through 2017. Data analysis was conducted April 2021 to June 2022. Exposures: The exposure of interest was a 3-category indicator of time, whether patients initiated dialysis before policies were enacted (2006-2010), in the first years of the Medicare ESKD PPS (2011-2013), or during the Medicare ESKD PPS and implementation of the ACA Marketplace (2014-2016). Main Outcomes and Measures: Patient-level Medicare enrollment through the first year of dialysis. Logistic regression and Cox models were used to examine associations of time, patient characteristics, and Medicare enrollment, adjusting for patient demographic, clinical, and market-level characteristics. Results: Of 335 157 patients aged 18 to 64 years with ESKD not actively enrolled in Medicare when they initiated dialysis in 2006 to 2016, the mean (SD) age was 49.9 (10.8) years, 198 164 (59.1%) were men, 188 290 (56.2%) were White, and 313 622 (93.6%) received in-center hemodialysis. New Medicare enrollment was higher in 2006 to 2010 (110 582 patients [73.1%]) than after the Medicare ESKD PPS and ACA Marketplace in 2014 to 2016 (55 382 patients [58.5%]). In adjusted analyses, declining Medicare enrollment was associated with implementation of 2011 Medicare ESKD PPS and 2014 ACA policies and was disproportionately lower among younger, racially minoritized, and ethnically Hispanic patients. Conclusions and Relevance: There was declining Medicare enrollment among new dialysis patients associated with the 2011 Medicare ESKD PPS and 2014 ACA Marketplace that raise concerns about benefits and harms to patients and payers and continued disparities in kidney care. As the dialysis payer mix moves toward higher proportions of patients not covered by Medicare, it will be important to understand the implications for health care system and patient outcomes.

Fitness of real-world data for clinical trial data collection: Results and lessons from a HARMONY Outcomes ancillary study.

BACKGROUND: Despite the extensive use of real-world data for retrospective, observational clinical research, our understanding of how real-world data might increase the efficiency of data collection in patient-level randomized clinical trials is largely unknown. The structure of real-world data is inherently heterogeneous, with each source electronic health record and claims database different from the next. Their fitness-for-use as data sources for multisite trials in the United States has not been established. METHODS: For a subset of participants in the HARMONY Outcomes Trial, we obtained electronic health record data from recruiting sites or Medicare claims data from the Centers for Medicare & Medicaid Services. For baseline characteristics and follow-up events, we assessed the level of agreement between these real-world data and data documented in the trial database. RESULTS: Real-world data-derived demographic information tended to agree with trial-reported demographic information, although real-world data were less accurate in identifying medical history. The ability of real-world data to identify baseline medication usage differed by real-world data source, with claims data demonstrating substantially better performance than electronic health record data. The limited number of lab results in the collected electronic health record data matched closely with values in the trial database. There were not enough follow-up events in the ancillary study population to draw meaningful conclusions about the performance of real-world data for identification of events. Based on the conduct of this ancillary study, the challenges and opportunities of using real-world data within clinical trials are discussed. CONCLUSION: Based on a subset of participants from the HARMONY Outcomes Trial, our results suggest that electronic health record or claims data, as currently available, are unlikely to be a complete substitute for trial data collection of medical history or baseline lab results, but that Medicare claims were able to identify most medications. The limited size of the study population prevents us from drawing strong conclusions based on these results, and other studies are clearly needed to confirm or refute these findings.