Pay-for-Performance Incentives for Home Dialysis Use and Kidney Transplant.

Importance: The Centers for Medicare & Medicaid Services' mandatory End-Stage Renal Disease Treatment Choices (ETC) model, launched on January 1, 2021, randomly assigned approximately 30% of US dialysis facilities and managing clinicians to financial incentives to increase the use of home dialysis and kidney transplant. Objective: To assess the ETC's association with use of home dialysis and kidney transplant during the model's first 2 years and examine changes in these outcomes by race, ethnicity, and socioeconomic status. Design, Setting, and Participants: This retrospective cross-sectional study used claims and enrollment data for traditional Medicare beneficiaries with kidney failure from 2017 to 2022 linked to same-period transplant data from the United Network for Organ Sharing. The study data span 4 years (2017-2020) before the implementation of the ETC model on January 1, 2021, and 2 years (2021-2022) following the model's implementation. Exposure: Receiving dialysis treatment in a region randomly assigned to the ETC model. Main Outcomes and Measures: Primary outcomes were use of home dialysis and kidney transplant. A difference-in-differences (DiD) approach was used to estimate changes in outcomes among patients treated in regions randomly selected for ETC participation compared with concurrent changes among patients treated in control regions. Results: The study population included 724 406 persons with kidney failure (mean [IQR] age, 62.2 [53-72] years; 42.5% female). The proportion of patients receiving home dialysis increased from 12.1% to 14.3% in ETC regions and from 12.9% to 15.1% in control regions, yielding an adjusted DiD estimate of -0.2 percentage points (pp; 95% CI, -0.7 to 0.3 pp). Similar analysis for transplant yielded an adjusted DiD estimate of 0.02 pp (95% CI, -0.01 to 0.04 pp). When further stratified by sociodemographic measures, including age, sex, race and ethnicity, dual Medicare and Medicaid enrollment, and poverty quartile, there was not a statistically significant difference in home dialysis use across joint strata of characteristics and ETC participation. Conclusions and Relevance: In this cross-sectional study, the first 2 years of the ETC model were not associated with increased use of home dialysis or kidney transplant, nor changes in racial, ethnic, and socioeconomic disparities in these outcomes.

Characterizing Fit-for-Purpose Real-World Data: An Assessment of a Mother-Infant Linkage in the Japan Medical Data Center Claims Database.

Purpose: Observational postapproval safety studies are needed to inform medication safety during pregnancy. Real-world databases can be valuable for supporting such research, but fitness for regulatory purpose must first be vetted. Here, we demonstrate a fit-for-purpose assessment of the Japan Medical Data Center (JMDC) claims database for pregnancy safety regulatory decision-making. Patients and Methods: The Duke-Margolis framework considers a database's fitness for regulatory purpose based on relevancy (capacity to answer the research question based on variable availability and a sufficiently sized, representative population) and quality (ability to validly answer the research question based on data completeness and accuracy). To assess these considerations, we examined descriptive characteristics of infants and pregnancies among females ages 12-55 years in the JMDC between January 2005 and March 2022. Results: For relevancy, we determined that critical data fields (maternal medications, infant major congenital malformations, covariates) are available. Family identification codes permitted linkage of 385,295 total mother-infant pairs, 57% of which were continuously enrolled during pregnancy. The prevalence of specific congenital malformation subcategories and maternal medical conditions were representative of the general population, but preterm births were below expectations (3.6% versus 5.6%) in this population. For quality, our methods are expected to accurately identify the complete set of mothers and infants with a shared health insurance plan. However, validity of gestational age information was limited given the high proportion (60%) of missing live birth delivery codes coupled with suppression of infant birth dates and inaccessibility of disease codes with gestational week information. Conclusion: The JMDC may be well suited for descriptive studies of pregnant people in Japan (eg, comorbidities, medication usage). More work is needed to identify a method to assign pregnancy onset and delivery dates so that in utero medication exposure windows can be defined more precisely as needed for many regulatory postapproval pregnancy safety studies.

Racial Disparities in COVID-19 Severity Are Partially Mediated by Chronic Stress-Evidence from a Large Integrated Healthcare System.

BACKGROUND: Racial and ethnic minorities have experienced a disproportionate burden of severe COVID-19. Whether chronic stress, also disproportionately experienced by racial and ethnic minorities, explains this excess risk is unknown. METHODS: We identified 9577 adults (≥ 18 years) diagnosed with COVID-19 from January 1, 2020, through September 30, 2021, enrolled in Kaiser Permanente Georgia (KPGA) with complete biomarker data. Self-reported race (Black or White) was defined from electronic medical records. Chronic stress, defined as allostatic load (AL), a composite score (scale 0-7) based on seven cardio-metabolic biomarkers, was categorized as below (low AL) or above (high AL) the median. Severe COVID-19 was defined as hospitalization or mortality within 30 days of COVID-19 diagnosis. The association between race, AL, and severe COVID-19 was assessed using multivariable Poisson regression. The mediating effect of AL was assessed using the Valeri and VanderWeele method. All results were expressed as risk ratios (RRs) with 95% confidence intervals. RESULTS: Overall, Black (vs. White) KPGA members had an 18% excess risk of AL (RR: 1.18, 95%CI: 1.14-1.23) and a 24% excess risk of severe COVID-19 (RR: 1.24, 95%CI: 1.12, 1.37). AL explained 23% of the Black-White disparities in severe COVID-19. CONCLUSIONS: In our study, chronic stress, characterized by AL, partially mediated Black-White disparities in severe COVID-19 outcomes.

Social Risk and Dialysis Facility Performance in the First Year of the ESRD Treatment Choices Model.

Importance: The End-Stage Renal Disease Treatment Choices (ETC) model randomly selected 30% of US dialysis facilities to receive financial incentives based on their use of home dialysis, kidney transplant waitlisting, or transplant receipt. Facilities that disproportionately serve populations with high social risk have a lower use of home dialysis and kidney transplant raising concerns that these sites may fare poorly in the payment model. Objective: To examine first-year ETC model performance scores and financial penalties across dialysis facilities, stratified by their incident patients' social risk. Design, Setting, and Participants: A cross-sectional study of 2191 US dialysis facilities that participated in the ETC model from January 1 through December 31, 2021. Exposure: Composition of incident patient population, characterized by the proportion of patients who were non-Hispanic Black, Hispanic, living in a highly disadvantaged neighborhood, uninsured, or covered by Medicaid at dialysis initiation. A facility-level composite social risk score assessed whether each facility was in the highest quintile of having 0, 1, or at least 2 of these characteristics. Main Outcomes and Measures: Use of home dialysis, waitlisting, or transplant; model performance score; and financial penalization. Results: Using data from 125 984 incident patients (median age, 65 years [IQR, 54-74]; 41.8% female; 28.6% Black; 11.7% Hispanic), 1071 dialysis facilities (48.9%) had no social risk features, and 491 (22.4%) had 2 or more. In the first year of the ETC model, compared with those with no social risk features, dialysis facilities with 2 or more had lower mean performance scores (3.4 vs 3.6, P = .002) and lower use of home dialysis (14.1% vs 16.0%, P < .001). These facilities had higher receipt of financial penalties (18.5% vs 11.5%, P < .001), more frequently had the highest payment cut of 5% (2.4% vs 0.7%; P = .003), and were less likely to achieve the highest bonus of 4% (0% vs 2.7%; P < .001). Compared with all other facilities, those in the highest quintile of treating uninsured patients or those covered by Medicaid experienced more financial penalties (17.4% vs 12.9%, P = .01) as did those in the highest quintile in the proportion of patients who were Black (18.5% vs 12.6%, P = .001). Conclusions: In the first year of the Centers for Medicare & Medicaid Services' ETC model, dialysis facilities serving higher proportions of patients with social risk features had lower performance scores and experienced markedly higher receipt of financial penalties.

Defining the Need for Causal Inference to Understand the Impact of Social Determinants of Health: A Primer on Behalf of the Consortium for the Holistic Assessment of Risk in Transplantation (CHART).

Objective: This study aims to introduce key concepts and methods that inform the design of studies that seek to quantify the causal effect of social determinants of health (SDOH) on access to and outcomes following organ transplant. Background: The causal pathways between SDOH and transplant outcomes are poorly understood. This is partially due to the unstandardized and incomplete capture of the complex interactions between patients, their neighborhood environments, the tertiary care system, and structural factors that impact access and outcomes. Designing studies to quantify the causal impact of these factors on transplant access and outcomes requires an understanding of the fundamental concepts of causal inference. Methods: We present an overview of fundamental concepts in causal inference, including the potential outcomes framework and direct acyclic graphs. We discuss how to conceptualize SDOH in a causal framework and provide applied examples to illustrate how bias is introduced. Results: There is a need for direct measures of SDOH, increased measurement of latent and mediating variables, and multi-level frameworks for research that examine health inequities across multiple health systems to generalize results. We illustrate that biases can arise due to socioeconomic status, race/ethnicity, and incongruencies in language between the patient and clinician. Conclusions: Progress towards an equitable transplant system requires establishing causal pathways between psychosocial risk factors, access, and outcomes. This is predicated on accurate and precise quantification of social risk, best facilitated by improved organization of health system data and multicenter efforts to collect and learn from it in ways relevant to specialties and service lines.

The Association Between Black vs. White Race and 30-Day Hospitalization Among People Diagnosed with COVID-19 Within an Integrated Care Setting: a Cohort Study.

BACKGROUND: Black Americans are more likely to experience hospitalization from COVID-19 compared with White Americans. Whether this excess risk differs by age, sex, obesity, or diabetes, key risk factors for COVID hospitalization, among an integrated population with uniform healthcare access, are less clear. METHODS: We identified all adult members (≥ 18 years) of Kaiser Permanente Georgia (KPGA) diagnosed with COVID-19 between January 1, 2020, and September 30, 2021 (N = 24,564). We restricted the analysis to members of Black or White race identified from electronic medical records. Our primary outcome was first hospitalization within 30 days of COVID-19 diagnosis. To assess the association between race and 30-day hospitalization, we performed multivariable logistic regression adjusting for several member and neighborhood-level characteristics, and tested for interactions of race with age, sex, diabetes, and obesity. A regression-based decomposition method was then used to estimate how much of the observed race disparity in 30-day hospitalization could be explained by member and neighborhood-level factors. RESULTS: Overall, 11.27% of Black KPGA members were hospitalized within 30 days of a COVID diagnosis, as compared with 9.44% of White KPGA members. Black (vs. White) KPGA members had a 34% (aOR: 1.32 [95% CI: 1.19-1.47]) higher odds of 30-day hospitalization following COVID-19 after accounting for clinical differences. The odds of 30-day hospitalization in Black vs. White KPGA members did not differ significantly by sex (men: 1.46 [1.25-1.70]; women: 1.24 [1.07-1.43]), by age (18-29 years: 1.33 [0. 841-2.10]; 30-49 years: 1.26 [1.02-1.56]; ≥ 50 years: 1.24 [1.10-1.41]); by diabetes status (with diabetes: 1.38 [1.16-1.66]; without diabetes: 1.26 [1.11-1.44]), or by obesity (with obesity: 1.31 [1.15-1.50]; without obesity: 1.28 [1.06-1.53]). Factors that, if Black and White KPGA members had the same level of exposure, would be most likely to reduce the Black-White disparity in 30-day hospitalization from COVID-19 were obesity, history of flu vaccine, and neighborhood-level income and social vulnerability. CONCLUSIONS: Early in the pandemic, Black (vs. White) members of an integrated health system had higher odds of being hospitalized within 30 days of COVID-19 diagnosis and this excess risk was similar by sex, age, and comorbidities. Factors that explained the largest proportions of race-based disparities were obesity, receipt of flu vaccine, and neighborhood-level social determinants of health. These findings suggest that social determinants of health, or other unmeasured factors, may be drivers of racial disparities in COVID-19 outcomes.

Racial Differences in Vascular Assessment Prior to Amputation in the Veterans Health Administration.

Purpose: It is unclear whether disparities in the care provided before lower extremity amputation (LEA) is driven by differences in receipt of diagnostic work-up versus revascularization attempts. Methods: We performed a national cohort study of Veterans who underwent LEA between March 2010 and February 2020 to assess receipt of vascular assessment with arterial imaging and/or revascularization in the year prior to LEA. Results: Among 19,396 veterans (mean age 66.8 years; 26.6% Black), Black veterans had diagnostic procedures more often than White veterans (47.5% vs. 44.5%) and revascularization as often (25.8% vs. 24.5%). Conclusion: We must identify patient and facility-level factors associated with LEA as disparities do not appear related to differences in attempted revascularization.

Contribution of Estimates of Glomerular Filtration to the Extensive Disparities in Preemptive Listing for Kidney Transplant.

Introduction: The use of race coefficients in equations for estimated glomerular filtration rate (eGFR) may have contributed to racial disparities in access to preemptive (without dialysis exposure) kidney transplantation (Ktx). Methods: In this retrospective national cohort study of incident kidney transplant candidates in the United States from 2001 to 2019, we describe temporal trends and racial disparities in preemptive listing and the distribution of eGFR at listing, using eGFR as reported and after removing the race coefficient for Black candidates. Results: Among 511,686 candidates, preemptive listing increased over time, from 18% in 2001 to 33% in 2019. Non-Black candidates were listed preemptively nearly twice as frequently as Black candidates in 2019 (38% vs. 21% preemptive) and at higher eGFR values (median 15.6 vs. 15.0 ml/min per 1.73 m2). After adjusting for candidate characteristics, including listing eGFR without the race coefficient, preemptive Black candidates still had significantly lower odds of preemptive deceased donor (DD) kidney transplantation compared to non-Black candidates (odds ratio 0.87, 95% confidence interval: 0.78-0.98). Conclusions: Over the last 2 decades, Black patients were consistently less likely to be listed preemptively and were listed at lower eGFR values. Adjusting for listing eGFR with the race coefficient computationally removed did not eliminate the racial disparity, suggesting that additional efforts are needed to achieve equity in preemptive transplantation beyond adopting race-free eGFR equations.

The ASCENT Intervention to Improve Access and Reduce Racial Inequalities in Kidney Waitlisting: A Randomized, Effectiveness-Implementation Trial.

BACKGROUND: The US kidney allocation system (KAS) changed in 2014, but dialysis facility staff (including nephrologists, social workers, nurse managers, and facility administrators) had low awareness of how this policy change could affect their patients' access to transplant. We assessed the effectiveness of a multicomponent and multilevel educational and outreach intervention targeting US dialysis facilities with low waitlisting, with a goal of increasing waitlisting and reducing Black versus White racial disparities in waitlisting. METHODS: The Allocation System Changes for Equity in Kidney Transplantation (ASCENT) study was a cluster-randomized, pragmatic, multilevel, effectiveness-implementation trial including 655 US dialysis facilities with low waitlisting, randomized to receive either the ASCENT intervention (a performance feedback report, a webinar, and staff and patient educational videos) or an educational brochure. Absolute and relative differences in coprimary outcomes (1-year waitlisting and racial differences in waitlisting) were reported among incident and prevalent patients. RESULTS: Among 56,332 prevalent patients, 1-year waitlisting decreased for patients in control facilities (2.72%-2.56%) and remained the same for patients in intervention facilities (2.68%-2.75%). However, the proportion of prevalent Black patients waitlisted in the ASCENT interventions increased from baseline to 1 year (2.52%-2.78%), whereas it remained the same for White patients in the ASCENT intervention facilities (2.66%-2.69%). Among incident patients in ASCENT facilities, 1-year waitlisting increased among Black patients (from 0.87% to 1.07%) but declined among White patients (from 1.54% to 1.27%). Significant racial disparities in waitlisting were observed at baseline, with incident Black patients in ASCENT facilities less likely to waitlist compared with White patients (adjusted odds ratio [aOR], 0.56; 95% confidence interval [CI], 0.35 to 0.92), but 1 year after the intervention, this racial disparity was attenuated (aOR, 0.84; 95% CI, 0.49 to 1.42). CONCLUSIONS: The ASCENT intervention may have a small effect on extending the reach of the new KAS policy by attenuating racial disparities in waitlisting among a population of US dialysis facilities with low waitlisting. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: National Institutes of Health ( NCT02879812 ). PODCAST: This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/CJASN/2023_03_08_CJN09760822.mp3.

Pain experiences among those living with hidradenitis suppurativa: a qualitative study.

BACKGROUND: Pain is rated by patients with hidradenitis suppurativa (HS) as the disease's most impactful symptom. HS therapies are often insufficient to control inflammatory disease activity and pain. A better understanding of patient experiences with pain may improve patient-provider relationships and help identify strategies for addressing HS pain. OBJECTIVES: This qualitative study sought to characterize lived pain experiences of those with HS. METHODS: English-speaking patients ≥ 18 years old with a dermatologist-confirmed diagnosis of HS and an average numerical rating scale pain score of ≥ 1 over the preceding week were recruited from a single academic medical centre in Atlanta, Georgia, USA. Semistructured interviews were conducted from November 2019 to March 2020 to explore participants' HS pain experiences and the subsequent impact on their lives. Thematic saturation was reached after interviewing 21 participants. Interviews were audio recorded, transcribed, and analysed using thematic analysis. RESULTS: Among 21 study participants, the median 7-day average pain score was 6 (interquartile range 3-7; scale ranges from 0 to 10, with 10 being most pain). Participants' descriptions of pain were consistent with nociceptive pain, neuropathic pain and itch. Pain impacted multiple life domains, including physical limitations (decreased mobility and impaired sleep), decreased psychological wellbeing (irritability, depression, loss of control, and difficulty communicating pain experiences) and impaired social relationships (social isolation, intimacy problems and difficulty fulfilling social responsibilities). Although participants reported chronic discomfort, acutely painful and unpredictable HS disease flares caused more distress and quality-of-life (QoL) burden. Participants frequently treated their pain without input from the medical team, sometimes with unsafe medication doses or combinations. Factors contributing to self-management of pain included difficulty accessing timely outpatient care during disease flares and fear of stigma from healthcare providers. CONCLUSIONS: When present, HS-related pain may impact not only physical wellbeing but also mental health and relationships. In addition to therapies that target the inflammatory disease burden, treating the symptom of pain may improve patients' QoL and wellbeing. Because patients with HS have difficulty explaining their pain, proactively asking them about pain may identify unmet needs, facilitate better pain control and improve QoL. Further, the influence of HS-related pain on numerous aspects of QoL suggests the need for multidisciplinary, patient-centred approaches to HS pain management.

Barriers of Acceptance to Hospice Care: a Randomized Vignette-Based Experiment.

BACKGROUND: The per diem financial structure of hospice care may lead agencies to consider patient-level factors when weighing admissions. OBJECTIVE: To investigate if treatment cost, disease complexity, and diagnosis are associated with hospice willingness to accept patients. DESIGN: In this 2019 online survey study, individuals involved in hospice admissions decisions were randomized to view one of six hypothetical patient vignettes: "high-cost, high-complexity," "low-cost, high-complexity," and "low-cost, low-complexity" within two diseases: heart failure and cystic fibrosis. Vignettes included demographics, prognoses, goals, and medications with costs. Respondents indicated their perceived likelihood of acceptance to their hospice; if likelihood was <100%, respondents were asked the barriers to acceptance. We used bivariate tests to examine associations between demographic, clinical, and organizational factors and likelihood of acceptance. PARTICIPANTS: Individuals involved in hospice admissions decisions MAIN MEASURES: Likelihood of acceptance to hospice care KEY RESULTS: N=495 (76% female, 53% age 45-64). Likelihoods of acceptance in cystic fibrosis were 79.8% (high-cost, high-complexity), 92.4% (low-cost, high-complexity), and 91.5% (low-cost, low-complexity), and in heart failure were 65.9% (high-cost, high-complexity), 87.3% (low-cost, high-complexity), and 96.6% (low-cost, low-complexity). For both heart failure and cystic fibrosis, respondents were less likely to accept the high-cost, high-complexity patient than the low-cost, high-complexity patient (65.9% vs. 87.3%, 79.8% vs. 92.4%, both p<0.001). For heart failure, respondents were less likely to accept the low-cost, high-complexity patient than the low-cost, low-complexity patient (87.3% vs. 96.6%, p=0.004). Treatment cost was the most common barrier for 5 of 6 vignettes. CONCLUSIONS: This study suggests that patients receiving expensive and/or complex treatments for palliation may have difficulty accessing hospice.

County-Level Characteristics Associated with Variation in ESKD Mortality in the United States, 2010-2018.

Background: Geographic and neighborhood-level factors, such as poverty and education, have been associated with an increased risk for incident ESKD, likelihood of receiving pre-ESKD care, and likelihood of receiving a transplant. However, few studies have examined whether these same factors are associated with ESKD mortality. In this study, we examined county-level variation in ESKD mortality and identified county-level characteristics associated with this variation. Methods: We identified 1,515,986 individuals (aged 18-84 years) initiating RRT (dialysis or transplant) between 2010 and 2018 using the United States Renal Data System. Among 2781 counties, we estimated county-level, all-cause, age-standardized mortality rates (ASMR) among patients with ESKD. We then identified county-level demographic (e.g., percent female), socioeconomic (e.g., percent unemployed), healthcare (e.g., percent without health insurance), and health behavior (e.g., percent current smokers) characteristics associated with ASMR using multivariable hierarchic linear mixed models and quantified the percentage of ASMR variation explained by county-level characteristics. Results: County-level ESKD ASMR ranged from 45 to 1022 per 1000 person-years (PY) (mean, 119 per 1000 PY). ASMRs were highest in counties located in the Tennessee Valley and Appalachia regions, and lowest in counties located in New England, the Pacific Northwest, and Southern California. In fully adjusted models, county-level characteristics significantly associated with higher ESKD mortality included a lower percentage of Black residents (-4.94 per 1000 PY), lower transplant rate (-4.08 per 1000 PY), and higher healthcare expenditures (5.21 per 1000 PY). Overall, county-level characteristics explained 19% of variation in ESKD mortality. Conclusions: Counties with high ESKD-related mortality may benefit from targeted and multilevel interventions that combine knowledge from a growing evidence base on the interplay between individual and community-level factors associated with ESKD mortality.

Understanding Racial Disparities in COVID-19-Related Complications: Protocol for a Mixed Methods Study.

BACKGROUND: In the United States, the COVID-19 pandemic has magnified the disproportionate and long-standing health disparities experienced by Black communities. Although it is acknowledged that social determinants of health (SDOH) rather than biological factors likely contribute to this disparity, few studies using rigorous analytic approaches in large, information-rich community-based data sets are dedicated to understanding the underlying drivers of these racial disparities. OBJECTIVE: The overall aim of our study is to elucidate the mechanisms by which racial disparities in severe COVID-19 outcomes arise, using both quantitative and qualitative methods. METHODS: In this protocol, we outline a convergent parallel mixed methods approach to identifying, quantifying, and contextualizing factors that contribute to the dramatic disparity in COVID-19 severity (ie, hospitalization, mortality) in Black versus white COVID-19 patients within the integrated health care system of Kaiser Permanente Georgia (KPGA). Toward this end, we will generate two quantitative cohorts of KPGA members with a confirmed COVID-19 diagnosis between January 1, 2020, and September 30, 2021: (1) an electronic medical record (EMR) cohort including routinely captured data on diagnoses, medications, and laboratory values, and a subset of patients hospitalized at Emory Healthcare to capture additional in-hospital data; and (2) a survey cohort, where participants will answer a range of questions related to demographics (eg, race, education), usual health behaviors (eg, physical activity, smoking), impact of COVID-19 (eg, job loss, caregiving responsibilities), and medical mistrust. Key outcomes of interest for these two cohorts include hospitalization, mortality, intensive care unit admission, hospital readmission, and long COVID-19. Finally, we will conduct qualitative semistructured interviews to capture perceptions of and experiences of being hospitalized with COVID-19 as well as related interactions with KPGA health care providers. We will analyze and interpret the quantitative and qualitative data separately, and then integrate the qualitative and quantitative findings using a triangulation design approach. RESULTS: This study has been funded by a Woodruff Health Sciences grant from December 2020 to December 2022. As of August 31, 2022, 31,500 KPGA members diagnosed with COVID-19 have been included in the EMR cohort, including 3028 who were hospitalized at Emory Healthcare, and 482 KPGA members completed the survey. In addition, 20 KPGA members (10 Black and 10 white) have been interviewed about their experiences navigating care with COVID-19. Quantitative and qualitative data cleaning and coding have been completed. Data analysis is underway with results anticipated to be published in December 2022. CONCLUSIONS: Results from this mixed methods pilot study in a diverse integrated care setting in the southeastern United States will provide insights into the mechanisms underpinning racial disparities in COVID-19 complications. The quantitative and qualitative data will provide important context to generate hypotheses around the mechanisms for racial disparities in COVID-19, and may help to inform the development of multilevel strategies to reduce the burden of racial disparities in COVID-19 and its ongoing sequelae. Incorporating contextual information, elucidated from qualitative interviews, will increase the efficacy, adoption, and sustainability of such strategies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/38914.

Treatment Patterns and Characteristics of Dialysis Facilities Randomly Assigned to the Medicare End-Stage Renal Disease Treatment Choices Model.

Importance: In 2021, Medicare launched the End-Stage Renal Disease Treatment Choices (ETC) model, which randomly assigned approximately 30% of dialysis facilities to new financial incentives to increase use of transplantation and home dialysis; these financial bonuses and penalties are calculated by comparing living-donor transplantation, transplant wait-listing, and home dialysis use in ETC-assigned facilities vs benchmarks from non-ETC-assigned (ie, control) facilities. Because model participation is randomly assigned, evaluators may attribute any downstream differences in outcomes to facility performance rather than any imbalance in baseline characteristics. Objective: To identify preintervention imbalances in dialysis facility characteristics that should be recognized in any ETC model evaluations. Design, Setting, and Participants: This cross-sectional study compared ETC-assigned and control dialysis facility characteristics in the United States from 2017 to 2018. A total of 6062 facilities were included. Data were analyzed from February 2021 to May 2022. Exposures: Assignment to the ETC model. Main Outcomes and Measures: Dialysis facilities' preintervention transplantations and home dialysis use, facility characteristics (notably, profit and chain status), patient demographic characteristics, and community socioeconomic characteristics. Results: Among 316 927 patients, with 6 178 855 attributed patient-months, the mean (SD) age in January 2017 was 59 (11) years, and 132 462 (42%) were female. Patients in ETC-assigned facilities had 9% (0.2 [95% CI, 0.1-0.2] percentage points) lower prevalence of living donor transplantation, 12% (3.2 [95% CI, 3.0-3.3] percentage points) lower prevalence of transplantation wait-listing, and 4% (0.4 [95% CI, 0.3-0.4] percentage points) lower prevalence of peritoneal dialysis use compared with control facilities. ETC-assigned facilities were 14% (5.1 [95% CI, 0.9-9.4] percentage points) more likely than control facilities to be owned by the second largest dialysis organization. Relative to control facilities, ETC-assigned facilities also treated 34% (6.6 [95% CI, 6.5-6.7] percentage point) fewer patients with Hispanic ethnicity and were located in communities with median household incomes that were 4% ($2500; 95% CI, $500-$4500) lower on average. Conclusions and Relevance: In this study, dialysis facilities in ETC-assigned regions had lower preintervention prevalence of transplantation wait-listing, living donor transplantation, and peritoneal dialysis use, relative to control facilities. ETC-assigned and control facilities also differed with respect to other facility, patient, and community characteristics. Evaluators should account for these preintervention imbalances to minimize bias in their inferences about the model's association with postintervention outcomes.

Past and Present Policy Efforts in Achieving Racial Equity in Kidney Transplantation.

Purpose of Review: Inequities in transplant access for underrepresented minorities and people of low socioeconomic status persist. The central principle to organ allocation, the "Final Rule" is grounded on "equitable allocation of cadaveric organs," regardless of background, including race/ethnicity, gender, and socioeconomic status, and there have been ongoing previous and current efforts in achieving the goal of equity in access to transplantation. Recent Findings: Some of these disparities are caused by impeded access to the transplant waiting list (i.e., lack of referral to transplantation, socioeconomic constraints) and are somewhat beyond the purview of Organ Procurement and Transplantation Network/United Network for Organ Sharing (OPTN/UNOS) policy. This paper examines past and present OPTN/UNOS policy efforts that strive to make access to kidney transplantation more racially equitable. Summary: Past and current policy efforts have brought the transplant community closer to the goal of achieving equity in access to transplantation. More comprehensive data collection may aid in further understanding existing challenges.

Gender Disparities in Kidney Transplantation Referral Vary by Age and Race: A Multiregional Cohort Study in the Southeast United States.

Introduction: Men (vs. women) are more likely to be waitlisted or receive a kidney transplant. Whether gender disparities exist in earlier transplant steps (i.e., referral) and whether age, race, or obesity factors play a role are unknown. Methods: Adults (18-80 years; N = 45,015) initiating dialysis in Georgia (GA), North Carolina (NC), or South Carolina (SC) (2012-2016) from the United States Renal Data System were linked to the Early Transplant Access Registry, with follow-up to December 2017. Using a mixed-effects logistic regression model adjusted for several patient characteristics, we assessed the association between gender and referral within 12 months, including interaction terms for age, race/ethnicity, and obesity. Results: Overall, 37.0% and 41.5% of women and men, respectively, were referred within 12 months. In fully adjusted models, women (vs. men) were 14% less likely to be referred (odds ratio [OR]: 0.86; 95% CI: 0.82-0.90). Women (vs. men) aged 45 to 64 years and 65 to 80 years were 0.93 (0.87-0.99) and 0.72 (0.66-0.77) less likely to be referred, respectively. Women (vs. men) of non-Hispanic White and non-Hispanic Black race were 0.76 (0.71-0.82) and 0.93 (0.88-0.99) less likely to be referred, respectively. For other race (Hispanic, other) and age (18-44 years) subgroups, and all obesity subgroups, no gender differences in referral rates were observed. Conclusion: In the Southeast, women are less likely to be referred for a transplant, and this disparity is specific to older non-Hispanic Black and White women. These findings have important implications for known gender disparities in upstream (i.e., waitlisting) transplant steps and in the design of interventions to reduce gender disparities in transplant.