by
Vijay Subramanian;
Christopher Anderson;
Seth Karp;
Stephen Pastan;
David Gerber;
Jayme Locke;
Ari Cohen;
Malay Shah;
Vincent Casingal;
Robert Strata;
Neeraj Singh;
Derek DuBay;
Kiran Dhanireddy
During the early wave of the COVID-19 pandemic, the Scientific Registry of Transplant Recipients (SRTR) designated a “black out” period between March 12, 2020, and June 12, 2020, for transplant outcomes reporting. We discuss the implications and potential bias it has introduced as it may selectively favor the outcomes for certain regions and harm other regions due to varied effects of different waves of COVID-19 infections across the United States. (Figure presented.).
Belatacept results in improved kidney transplant outcomes, but utilization has been limited by logistical barriers related to monthly (q1m) intravenous infusions. Every 2-month (q2m) belatacept has potential to increase utilization, therefore we conducted a randomized noninferiority trial in low immunologic risk renal transplant recipients greater than 1-year posttransplant. Patients on belatacept were randomly assigned to q1m or q2m therapy. The primary objective was a noninferiority comparison of renal function (eGFR) at 12 months with a noninferiority margin (NIM) of 6.0 ml/min/1.73 m2. One hundred and sixty-six participants were randomized to q1m (n = 82) or q2m (n = 84) belatacept, 163 patients received treatment, and 76 q1m and 77 q2m subjects completed the 12-month study period. Every 2-month belatacept was noninferior to q1m, as the difference in mean eGFR adjusted for baseline renal function did not exceed the NIM. Two-month dosing was safe and well tolerated, with no patient deaths or graft losses. Four rejection episodes and three cases of donor-specific antibodies (DSAs) occurred among q2m subjects; however, only one rejection and one instance of DSA were observed in subjects adherent to the study protocol. Every 2-month belatacept therapy may facilitate long-term utilization of costimulation blockade, but future multicenter studies with long-term follow-up will further elucidate immunologic risk. (ClinicalTrials.gov NCT02560558).
Although research shows that minorities exhibit higher levels of medical mistrust, perceived racism, and discrimination in healthcare settings, the degree to which these underlying sociocultural factors preclude end-stage renal disease (ESRD) patients from initiating kidney transplant evaluation is unknown. We telephone surveyed 528 adult ESRD patients of black or white race referred for evaluation to a Georgia transplant center (N = 3) in 2014-2016. We used multivariable logistic regression to examine associations between sociocultural factors and evaluation initiation, adjusting for demographic, clinical, and socioeconomic characteristics. Despite blacks (n = 407) reporting higher levels of medical mistrust (40.0% vs 26.4%, P <.01), perceived racism (55.5% vs 18.2%, P <.01), and experienced discrimination (29.0% vs 15.7%, P <.01) than whites (n = 121), blacks were only slightly less likely than whites to initiate evaluation (49.6% vs 57.9%, P =.11). However, after adjustment, medical mistrust (odds ratio [OR]: 0.59; 95% confidence interval [CI]: 0.39, 0.91), experienced discrimination (OR: 0.62, 95% CI: 0.41, 0.95), and perceived racism (OR: 0.61; 95% CI: 0.40, 0.92) were associated with lower evaluation initiation. Results suggest that sociocultural disparities exist in early kidney transplant access and occur despite the absence of a significant racial disparity in evaluation initiation. Interventions to reduce disparities in transplantation access should target underlying sociocultural factors, not just race.
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 316927 patients, with 6178855 attributed patient-months, the mean (SD) age in January 2017 was 59 (11) years, and 132462 (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..
Variability in transplant access exists, but barriers to referral and evaluation are underexplored due to lack of national surveillance data. We examined referral for kidney transplantation evaluation and start of the evaluation among 34 857 incident, adult (18-79 years) end-stage kidney disease patients from 690 dialysis facilities in the United States Renal Data System from January 1, 2012 through August 31, 2016, followed through February 2018 and linked data to referral and evaluation data from nine transplant centers in Georgia, North Carolina, and South Carolina. Multivariable-adjusted competing risk analysis examined each outcome. The median within-facility cumulative percentage of patients referred for kidney transplantation within 1 year of dialysis at the 690 dialysis facilities in Network 6 was 33.7% (interquartile range [IQR]: 25.3%-43.1%). Only 48.3% of referred patients started the transplant evaluation within 6 months of referral. In multivariable analyses, factors associated with referral vs evaluation start among those referred at any time differed. For example, black, non-Hispanic patients had a higher rate of referral (hazard ratio [HR]: 1.22; 95% confidence interval [CI]: 1.18-1.27), but lower evaluation start among those referred (HR: 0.93; 95% CI: 0.88-0.98), vs white non-Hispanic patients. Barriers to transplant varied by step, and national surveillance data should be collected on early transplant steps to improve transplant access.
Racial disparities in access to renal transplantation exist, but the effects of race and socioeconomic status (SES) on early steps of renal transplantation have not been well explored. Adult patients referred for renal transplant evaluation at a single transplant center in the Southeastern United States from 2005 to 2007, followed through May 2010, were examined. Demographic and clinical data were obtained from patient's medical records and then linked with United States Renal Data System and American Community Survey Census data. Cox models examined the effect of race on referral, evaluation, waitlisting and organ receipt. Of 2291 patients, 64.9% were black, the mean age was 49.4 years and 33.6% lived in poor neighborhoods. Racial disparities were observed in access to referral, transplant evaluation, waitlisting and organ receipt. SES explained almost one-third of the lower rate of transplant among black versus white patients, but even after adjustment for demographic, clinical and SES factors, blacks had a 59% lower rate of transplant than whites (hazard ratio = 0.41; 95% confidence interval: 0.28–0.58). Results suggest that improving access to healthcare may reduce some, but not all, of the racial disparities in access to kidney transplantation.
Although kidney transplantation provides a significant benefit over dialysis, many patients with end-stage renal disease (ESRD) are conflicted about their decision to undergo kidney transplant. We aimed to identify the prevalence and characteristics associated with decisional conflict between treatment options in ESRD patients presenting for transplant evaluation. Among a cross-sectional sample of patients with ESRD (n=464) surveyed in 2014 and 2015, we assessed decisional conflict through a validated 10-item questionnaire. Decisional conflict was dichotomized into no decisional conflict (score=0) and any decisional conflict (score>0). We investigated potential characteristics of patients with decisional conflict using bivariate and multivariable logistic regression. The overall mean age was 50.6 years, with 62% male patients and 48% African American patients. Nearly half (48.5%) of patients had decisional conflict regarding treatment options. Characteristics significantly associated with decisional conflict in multivariable analysis included male sex, lower educational attainment, and less transplant knowledge. Understanding characteristics associated with decisional conflict in patients with ESRD could help identify patients who may benefit from targeted interventions to help patients make informed, value-based, and supported decisions when deciding how to best treat their kidney disease.
by
Teri Browne;
Laura McPherson;
Samantha Retzloff;
Amandha Darius;
Adam Wilk;
Alexandra Cruz;
Shannon Wright;
Stephen Pastan;
Jennifer C Gander;
Alexander A Berlin;
Rachel Patzer
Rationale & Objective: There are many barriers to meeting the goal of increasing kidney transplants in the United States. It is important to understand dialysis and transplant center providers’ existing practices and identified barriers to increasing the number of dialysis patients who are evaluated for and get wait-listed for a transplant. Study Design: Cross-sectional survey of dialysis unit and transplant center staff in End Stage Renal Disease Network 6 (Georgia, North Carolina, South Carolina). Setting & Participants: Ninety-one transplant staff from all 9 transplant centers in the region and 421 dialysis staff from 421 facilities responded to the survey. Predictors: N/A Outcome: Provider perceptions of barriers faced by patients in the kidney transplant evaluation process and suggestions for improving care. Analytical Approach: Mixed methods. Descriptive analyses of responses to multiple-choice questions and qualitative analysis of open-ended survey responses. Results: The top 5 barriers to kidney transplantation as reported by transplant staff were transportation (63.7%), low health literacy (50.5%), lack of understanding about the transplant process (37.4%), distance to transplant center (29.7%), and low socioeconomic status (28.6%). When asked how dialysis units can help patients complete the evaluation process, the most common responses from transplant center staff were educating patients about transplant (54%), helping patients through steps in the process (35%), and better communication with transplant centers (15%). When dialysis unit staff were asked what could be done to help the facility improve its transplant wait-list rate, the most common responses were educational materials for patients and staff (55%), better communication with transplant centers (12%), and transportation and financial assistance (9%). Limitations: Survey responses are from 1 end stage renal disease network. Conclusions: Dialysis units, transplant centers, and ESRD networks can work together to help patients address key barriers to transplantation to improve the country's transplantation rate.
Background: Human adenovirus (HAdV) infections can lead to high mortality in solid organ transplant (SOT) recipients, with rare reports of donor-derived infection. Methods: Two renal transplant recipients with HAdV-11 infection who received kidneys from the same donor are described. Whole-genome sequencing (WGS) was performed. Results: WGS showed 100% nucleotide sequence identity for the 2 HAdV-11 isolates. The patients presented with distinct clinical syndromes, and both were treated with brincidofovir. Conclusions: Donor-derived HAdV infection is presumed to be low; however, disseminated HAdV in SOT recipients can be severe, and clinicians should be aware of the clinical course and treatment options.
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.