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1.
Am J Epidemiol ; 2024 Apr 06.
Article in English | MEDLINE | ID: mdl-38583932

ABSTRACT

Administrative claims databases often do not capture date or fact of death, so studies using these data may inappropriately treat death as a censoring event-equivalent to other withdrawal reasons-rather than a competing event. We examined 1-, 3-, and 5-year inverse-probability-of-treatment-weighted cumulative risks of a composite cardiovascular outcome among 34,527 initiators of telmisartan (exposure) and ramipril (referent) ages ≥55 in Optum claims from 2003 to 2020. Differences in cumulative risks of the cardiovascular endpoint due to censoring of death (cause-specific), as compared to treating death as a competing event (sub-distribution), increased with greater follow-up time and older age, where event and mortality risks were higher. Among ramipril users (selected results), 5-year cause-specific and sub-distribution cumulative risk estimates per 100, respectively, were 16.4 (95% CI 15.3, 17.5) and 16.2 (95% CI 15.1, 17.3) among ages 55-64 (difference=0.2) and were 43.2 (95% CI 41.3, 45.2) and 39.7 (95% CI 37.9, 41.4) among ages ≥75 (difference=3.6). Plasmode simulation results demonstrated the differences in cause-specific versus sub-distribution cumulative risks to increase with increasing mortality rate. We suggest researchers consider the cohort's baseline mortality risk when deciding whether real-world data with incomplete death information can be used without concern.

3.
Cancer Res Commun ; 4(4): 1111-1119, 2024 Apr 22.
Article in English | MEDLINE | ID: mdl-38517133

ABSTRACT

Liver transplantation offers the best survival for patients with early-stage hepatocellular carcinoma (HCC). Prior studies have demonstrated disparities in transplant access; none have examined the early steps of the transplant process. We identified determinants of access to transplant referral and evaluation among patients with HCC with a single tumor either within Milan or meeting downstaging criteria in Georgia.Population-based cancer registry data from 2010 to 2019 were linked to liver transplant centers in Georgia. Primary cohort: adult patients with HCC with a single tumor ≤8 cm in diameter, no extrahepatic involvement, and no vascular involvement. Secondary cohort: primary cohort plus patients with multiple tumors confined to one lobe. We estimated time to transplant referral, evaluation initiation, and evaluation completion, accounting for the competing risk of death. In sensitivity analyses, we also accounted for non-transplant cancer treatment.Among 1,379 patients with early-stage HCC in Georgia, 26% were referred to liver transplant. Private insurance and younger age were associated with increased likelihood of referral, while requiring downstaging was associated with lower likelihood of referral. Patients living in census tracts with ≥20% of residents in poverty were less likely to initiate evaluation among those referred [cause-specific hazard ratio (csHR): 0.62, 95% confidence interval (CI): 0.42-0.94]. Medicaid patients were less likely to complete the evaluation once initiated (csHR: 0.53, 95% CI: 0.32-0.89).Different sociodemographic factors were associated with each stage of the transplant process among patients with early-stage HCC in Georgia, emphasizing unique barriers to access and the need for targeted interventions at each step. SIGNIFICANCE: Among patients with early-stage HCC in Georgia, age and insurance type were associated with referral to liver transplant, race, and poverty with evaluation initiation, and insurance type with evaluation completion. Opportunities to improve transplant access include informing referring providers about insurance requirements, addressing barriers to evaluation initiation, and streamlining the evaluation process.


Subject(s)
Carcinoma, Hepatocellular , Health Services Accessibility , Healthcare Disparities , Liver Neoplasms , Liver Transplantation , Referral and Consultation , Humans , Liver Neoplasms/surgery , Liver Neoplasms/pathology , Liver Transplantation/statistics & numerical data , Carcinoma, Hepatocellular/surgery , Carcinoma, Hepatocellular/pathology , Male , Georgia/epidemiology , Female , Middle Aged , Referral and Consultation/statistics & numerical data , Health Services Accessibility/statistics & numerical data , Healthcare Disparities/statistics & numerical data , Aged , Adult , Registries
5.
Clin Epidemiol ; 16: 31-43, 2024.
Article in English | MEDLINE | ID: mdl-38313043

ABSTRACT

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.

6.
Kidney Int Rep ; 9(2): 225-238, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38344743

ABSTRACT

Introduction: The Allocation System for changes in Equity in Kidney Transplantation (ASCENT) study was a hybrid type 1 trial of a multicomponent intervention among 655 US dialysis facilities with low kidney transplant waitlisting to educate staff and patients about kidney allocation system (KAS) changes and increase access to and reduce racial disparities in waitlisting. Intervention components included a staff webinar, patient and staff educational videos, and facility-specific feedback reports. Methods: Implementation outcomes were assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework. Postimplementation surveys were administered among intervention group facilities (n = 334); interviews were conducted with facility staff (n = 6). High implementation was defined as using 3 to 4 intervention components, low implementation as using 1 to 2 components, and nonimplementation as using no components. Results: A total of 331 (99%) facilities completed the survey; 57% were high implementers, 31% were low implementers, and 12% were nonimplementers. Waitlisting events were higher or similar among high versus low implementer facilities for incident and prevalent populations; for Black incident patients, the mean proportion waitlisted in low implementer facilities was 0.80% (95% confidence interval [CI]: 0.73-0.87) at baseline and 0.55% at 1-year (95% CI: 0.48-0.62) versus 0.83% (95% CI: 0.78-0.88) at baseline and 1.40% at 1-year (95% CI: 1.35-1.45) in high implementer facilities. Interviews revealed that the intervention helped facilities prioritize transplant education, but that intervention components were not uniformly shared. Conclusion: The findings provide important context to interpret ASCENT effectiveness results and identified key barriers and facilitators to consider for future modification and scale-up of multilevel, multicomponent interventions in dialysis settings.

7.
JAMA ; 331(2): 124-131, 2024 01 09.
Article in English | MEDLINE | ID: mdl-38193961

ABSTRACT

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.


Subject(s)
Healthcare Disparities , Kidney Failure, Chronic , Reimbursement, Incentive , Renal Dialysis , Self Care , Social Determinants of Health , Aged , Female , Humans , Male , Black or African American/statistics & numerical data , Black People/statistics & numerical data , Cross-Sectional Studies , Healthcare Disparities/economics , Healthcare Disparities/ethnology , Healthcare Disparities/statistics & numerical data , Hispanic or Latino/statistics & numerical data , Kidney Failure, Chronic/economics , Kidney Failure, Chronic/epidemiology , Kidney Failure, Chronic/ethnology , Kidney Failure, Chronic/therapy , Kidney Transplantation/statistics & numerical data , Medicaid/economics , Medicaid/statistics & numerical data , Medically Uninsured/statistics & numerical data , Models, Economic , Reimbursement, Incentive/economics , Reimbursement, Incentive/statistics & numerical data , Renal Dialysis/economics , Renal Dialysis/methods , Renal Dialysis/statistics & numerical data , Social Determinants of Health/economics , Social Determinants of Health/ethnology , Social Determinants of Health/statistics & numerical data , United States/epidemiology , Vulnerable Populations/statistics & numerical data , Waiting Lists , Self Care/economics , Self Care/methods , Self Care/statistics & numerical data
8.
Article in English | MEDLINE | ID: mdl-38294635

ABSTRACT

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.

9.
JAMA Dermatol ; 160(2): 179-186, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38198173

ABSTRACT

Importance: Despite the US Food and Drug Administration's approval of adalimumab for the treatment of hidradenitis suppurativa (HS), prescription rates remain low, indicating a critical gap between evidence-based guidelines and clinical practice. Understanding the medical decision-making process that these patients use when considering biologic agents and other HS therapies may uncover opportunities for improved patient-physician communication and HS disease control. Objective: To elucidate factors that affect the medical decision-making process for patients with HS, with an emphasis on biologic therapies. Design, Setting, and Participants: Open-ended semistructured interviews were conducted with English-speaking adults with HS (aged ≥18 years) recruited from 2 dermatology clinics that are part of Emory University School of Medicine in Atlanta, Georgia. All participants had an average 7-day pain score of 1 or higher on a 0- to 10-point numeric rating scale. Surveys were conducted between November 2019 and March 2020, and data were analyzed from December 2021 to August 2022. Data collection continued until thematic saturation was reached at 21 interviews. Results: A total of 21 participants (median [IQR] age, 38.5 [27.9-43.4] years; 16 females [76%]) were included in the analysis. Almost all participants (96%) had Hurley stage II or III disease, and 15 (71%) had a history of adalimumab use. Suffering threshold, perceptions of treatment risk, treatment fatigue, disease understanding, and sources of information (included dermatologists, the internet, advertisements, and friends and loved ones) were identified as factors affecting participants' decisions to initiate new treatments for HS. Conclusions and Relevance: Results of this qualitative study suggest that mitigating misconceptions about treatment risk, identifying gaps in disease knowledge, and emphasizing early treatment to prevent scarring and disease progression may empower patients with HS to engage in treatment planning and to try new therapies.


Subject(s)
Hidradenitis Suppurativa , Adult , Female , Humans , Adolescent , Hidradenitis Suppurativa/drug therapy , Adalimumab/therapeutic use , Severity of Illness Index , Disease Progression , Patient Selection
10.
Am J Transplant ; 24(2): 190-212, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37704059

ABSTRACT

The Organ Procurement and Transplantation Network conducts a robust death verification process when augmenting the United States transplant registry with external sources of data. Process enhancements added over 35,000 externally verified deaths across waitlist candidates and transplant recipients for all organs beginning in April 2022. Ninety-four percent of added posttransplant deaths occurred beyond 5 years posttransplant, and over 74% occurred beyond 10 years. Deceased donor solid organ recipients transplanted from January 1, 2010, through October 31, 2020, were analyzed from January and July 2022 Organ Procurement and Transplantation Network Standard Transplant Analysis and Research and the Scientific Registry of Transplant Recipients Standard Analysis Files to quantify the impact of including vs excluding unverified deaths (not releasable to researchers) on posttransplant patient survival estimates. Across all organs, 1- and 5-year posttransplant survival rates were not substantially impacted; meaningful differences were observed in 10-year survival among kidney recipients. These findings bear important implications for anyone who utilized transplant registry data to examine long-term outcomes prior to the updated verification process. Users of transplant surveillance data should interpret results of long-term outcomes cautiously, particularly differences across subpopulations, and the transplant community should identify ways to improve data quality and minimize the reporting burden on transplant institutions.


Subject(s)
Tissue and Organ Procurement , Humans , United States/epidemiology , Registries , Transplant Recipients , Survival Rate , Tissue Donors
11.
Lupus ; 33(1): 48-57, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38019182

ABSTRACT

OBJECTIVE: For the majority of patients with lupus nephritis-related end-stage kidney disease (LN-ESKD), kidney transplant is associated with better outcomes than dialysis. Access to kidney transplant requires an initial referral to a transplant center and medical evaluation prior to waitlisting. The study's objective was to examine access to these early steps in the kidney transplant process among patients with LN-ESKD. METHODS: Adults who began treatment for ESKD in the Southeast, Northeast, New York, or Ohio River Valley U.S. regions from 1/1/2012 to 12/31/2019, followed through 6/30/2021, were identified from the United States Renal Data System. Referral and evaluation start data were collected from 28 of 48 transplant centers across these regions. The exposure was primary cause of ESKD (LN-ESKD vs other-ESKD). The outcomes were referral and evaluation start at a transplant center. Cox models quantified the association between LN-ESKD (vs other-ESKD) and referral and evaluation start. RESULTS: Among 192,318 patients initiating treatment for ESKD, 0.4% had LN-ESKD. Over half (58%) of LN-ESKD patients were referred before study end, and among those referred, 66% started the evaluation. In adjusted analyses, patients with LN-ESKD were referred (HR: 1.09, 95% CI: 0.99, 1.19) and started the transplant evaluation (HR: 1.13, 95% CI: 1.00, 1.28) at a higher rate than patients with other-ESKD. Among referred patients with LN-ESKD, the median time from ESKD start to referral was 2.9 months (IQR: <1 to 11.7 months), which is similar to patients with other-ESKD (median 2.6 months, IQR: <1 to 8.8 months). CONCLUSIONS: Among incident patients with ESKD, having a primary diagnosis of LN-ESKD versus other-ESKD is associated with higher rates of early transplant access outcomes. Despite this, patients with LN-ESKD (vs other-ESKD) are less likely to be preemptively referred (i.e., referred prior to ESKD start) for kidney transplant. While providers may no longer be delaying the early steps in the kidney transplantation process among this patient population, there is still room for improvement in the rates of preemptive referral. Access to kidney transplant referral prior to ESKD could result in increased transplant rates and better transplant outcomes for patients with LN-ESKD.


Subject(s)
Kidney Failure, Chronic , Kidney Transplantation , Lupus Erythematosus, Systemic , Lupus Nephritis , Adult , Humans , United States , Kidney Transplantation/adverse effects , Lupus Nephritis/complications , Lupus Nephritis/surgery , Lupus Nephritis/diagnosis , Lupus Erythematosus, Systemic/complications , Kidney Failure, Chronic/etiology , Kidney Failure, Chronic/surgery , Kidney Failure, Chronic/epidemiology , Referral and Consultation , Kidney
13.
Surg Infect (Larchmt) ; 25(1): 63-70, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38157325

ABSTRACT

Background: The Georgia Quality Improvement Program (GQIP) surgical collaborative participating hospitals have shown consistently poor performance in the post-operative sepsis category of National Surgical Quality Improvement Program data as compared with national benchmarks. We aimed to compare crude versus risk-adjusted post-operative sepsis rankings to determine high and low performers amongst GQIP hospitals. Patients and Methods: The cohort included intra-abdominal general surgery patients across 10 collaborative hospitals from 2015 to 2020. The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) sepsis definition was used among all hospitals for case abstraction and NSQIP data were utilized to train and validate a multivariable risk-adjustment model with post-operative sepsis as the outcome. This model was used to rank GQIP hospitals by risk-adjusted post-operative sepsis rates. Rankings between crude and risk-adjusted post-operative sepsis rankings were compared ordinally and for changes in tertile. Results: The study included 20,314 patients with 595 cases of post-operative sepsis. Crude 30-day post-operative sepsis risk among hospitals ranged from 0.81 to 5.11. When applying the risk-adjustment model which included: age, American Society of Anesthesiology class, case complexity, pre-operative pneumonia/urinary tract infection/surgical site infection, admission status, and wound class, nine of 10 hospitals were re-ranked and four hospitals changed performance tertiles. Conclusions: Inter-collaborative risk-adjusted post-operative sepsis rankings are important to present. These metrics benchmark collaborating hospitals, which facilitates best practice exchange from high to low performers.


Subject(s)
Sepsis , Urinary Tract Infections , Humans , United States , Risk Adjustment , Surgical Wound Infection/epidemiology , Hospitals , Sepsis/epidemiology , Quality Improvement , Postoperative Complications/epidemiology
15.
Ann Surg Open ; 4(3): e337, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38144885

ABSTRACT

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.

16.
Article in English | MEDLINE | ID: mdl-38110800

ABSTRACT

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.

17.
Kidney Int Rep ; 8(12): 2580-2591, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38106598

ABSTRACT

Introduction: We examined sex/gender disparities across the continuum of transplant care by attributed cause of end-stage kidney disease (ESKD). Methods: All adults (18-79 years; N = 43,548) with new-onset ESKD in Georgia, North Carolina, or South Carolina between 2015 and 2019 were identified from the United States Renal Data System (USRDS). Individuals were linked to the Early Steps to Transplant Access Registry (E-STAR) to obtain data on referral and evaluation. Waitlisting data was ascertained from USRDS. Using a Cox-proportional hazards model, with follow-up through 2020, we assessed the association between sex/gender and referral within 12 months (among all incident dialysis patients), evaluation start within 6 months (among referred patients), and waitlisting (among all evaluated patients) by attributed cause of ESKD (type 1 diabetes mellitus, type 2 diabetes mellitus, hypertension, glomerulonephritis, cystic disease, and other). Results: Overall, women (vs. men) with type 2 diabetes-attributed ESKD were 13% (crude hazard ratio [HR]: 0.87 [0.83-0.91]), 14% (crude HR: 0.86 [0.81-0.91]), and 14% (crude HR: 0.86 [0.78-0.94]) less likely to be referred, evaluated, and waitlisted, respectively. Women (vs. men) with hypertension-attributed ESKD were 14% (crude HR: 0.86 [0.82-0.90]) and 8% (crude HR: 0.92 [0.87-0.98]) less likely to be referred and evaluated, respectively, but similarly likely to be waitlisted once evaluated (crude HR: 1.06 [0.97-1.15]). For all other attributed causes of ESKD, there was no sex/gender disparity in referral, evaluation, or waitlisting rates. Conclusion: In the Southeast United States, sex/gender disparities in early access to kidney transplantation are specific to people with ESKD attributed to type 2 diabetes and hypertension.

19.
JAMA Intern Med ; 183(12): 1366-1375, 2023 Dec 01.
Article in English | MEDLINE | ID: mdl-37922156

ABSTRACT

Importance: Patients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant. Objectives: To evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant. Design, Setting, and Participants: This pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis). Interventions: Using stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders. Main Outcomes and Measures: The primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor. Results: The 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15). Conclusions and Relevance: This novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort. Trial Registration: ClinicalTrials.gov Identifier: NCT03329521.


Subject(s)
Kidney Transplantation , Renal Insufficiency, Chronic , Humans , Renal Dialysis , Renal Insufficiency, Chronic/surgery , Ontario , Kidney , Systems Analysis
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