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Abstract Background Determining whether a patient is eligible for kidney transplantation is complex. In this study, we estimate what proportion of patients with end-stage kidney disease (ESKD) might have been suitable candidates for kidney transplantation but were not referred. Methods We identified 43,952 people initiating dialysis for kidney failure between 2012 and 2017 in the states of Georgia, North Carolina, or South Carolina from the United States Renal Data System and linked to the Early-Steps to Transplant Access Registry to obtain data on referral and waitlisting up until December 2020. We identified ‘good transplant candidates’ as those who were waitlisted within 2-years of referral, among all patients referred within 1-year of dialysis initiation. Using propensity score cut-offs, logistic regression, and area under the curve (AUC), we then estimated the proportion of individuals who may have been good transplant candidates, but were not referred. Results Overall, 42.6% of incident dialysis patients were referred within one year and among them, 32.9% were waitlisted within 2 years of referral. Our model had reasonably good discrimination for identifying good transplant candidates with an AUC of 0.70 (95%CI 0.69–0.71), sensitivity of 0.68 and specificity of 0.61. Overall, 25% of individuals not referred for transplant may have been ‘good’ transplant candidates. Adding these patients to the existing 18,725 referred patients would increase the proportion of incident ESKD patients being referred within one year from 42.6% to 57.2% (a ~ 14.6% increase). Conclusions In this study, we show that a significant proportion of potentially good transplant candidates are not being referred for transplant. A ~ 14% increase in the proportion of patients being referred from dialysis facilities is both a meaningful and realistic goal and could lead to more qualified patients being referred and subsequently waitlisted for a lifesaving transplant.

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.

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.

Rationale & Objective: Patients with kidney failure from racial and ethnic minority groups and older patients have reduced access to the transplant waitlist relative to White and younger patients. Although racial disparities in the waitlisting group have declined after the 2014 kidney allocation system change, whether there is intersectionality of race and age in waitlisting access is unknown. Study Design: Retrospective cohort study. Setting & Participants: 439,455 non-Hispanic White and non-Hispanic Black US adults initiating dialysis between 2015 and 2019 were identified from the United States Renal Data System, and followed through 2020. Exposures: Patient race and ethnicity (non-Hispanic White and non-Hispanic Black) and age group (18-29, 30-49, 50-64, and 65-80 years). Outcomes: Placement on the United Network for Organ Sharing deceased donor waitlist. Analytical Approach: Age- and race-stratified waitlisting rates were compared. Multivariable Cox proportional hazards models, censored for death, examined the association between race and waitlisting, and included interaction term for race and age. Results: Over a median follow-up period of 1 year, the proportion of non-Hispanic White and non-Hispanic Black patients waitlisted was 20.7% and 20.5%, respectively. In multivariable models, non-Hispanic Black patients were 14% less likely to be waitlisted (aHR, 0.86, 95% CI, 0.77-0.95). Relative differences between non-Hispanic Black and non-Hispanic White patients were different by age group. Non-Hispanic Black patients were 27%, 12%, and 20% less likely to be waitlisted than non-Hispanic White patients for ages 18-29 years (aHR, 0.73; 95% CI, 0.61-0.86), 50-64 (aHR, 0.88; 95% CI, 0.80-0.98), and 65-80 years (aHR, 0.80; 95% CI, 0.71-0.90), respectively, but differences were attenuated among patients aged 30-49 years (aHR, 0.89; 95% CI, 0.77-1.02). Limitations: Race and ethnicity data is physician reported, residual confounding, and analysis is limited to non-Hispanic White and non-Hispanic Black patients. Conclusions: Racial disparities in waitlisting exist between non-Hispanic Black and non-Hispanic White individuals and are most pronounced among younger patients with kidney failure. Results suggest that interventions to address inequalities in waitlisting may need to be targeted to younger patients with kidney failure. Plain-Language Summary: Research has shown that patients from racial and ethnic minority groups and older patients have reduced access to transplant waitlisting relative to White and younger patients; nevertheless, how age impacts racial disparities in waitlisting is unknown. We compared waitlisting between non-Hispanic Black and non-Hispanic White patients with incident kidney failure, within age strata, using registry data for 439,455 US adults starting dialysis (18-80 years) during 2015-2019. Overall, non-Hispanic Black patients were less likely to be waitlisted and relative differences between the two racial groups differed by age. After adjusting for patient-level factors, the largest disparity in waitlisting was observed among adults aged 18-29 years. These results suggest that interventions should target younger adults to reduce disparities in access to kidney transplant waitlisting.

Background: Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant. Objective: To prespecify the statistical analysis plan for the EnAKT LKD trial. Design: The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the “clusters”). Setting: Twenty-six CKD programs in Ontario, Canada. Participants: More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant. Methods: The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the “registry”). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Outcomes: The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor. Analysis plan: Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs. Trial Status: The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases. Trial Registration: The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521 ). Statistical Analytic Plan: Version 1.0 August 26, 2022.

Introduction: The coronavirus 2019 (COVID-19) pandemic has created significant burden on healthcare systems throughout the world. Syndromic surveillance, which collects real-time data based on a range of symptoms rather than laboratory diagnoses, can help provide timely information in emergency response. We examined the effectiveness of a web-based COVID-19 symptom checking tool (C19Check) in the state of Georgia (GA) in predicting COVID-19 cases and hospitalizations. Methods: We analyzed C19Check use data, COVID-19 cases, and hospitalizations from April 22–November 28, 2020. Cases and hospitalizations in GA were extracted from the Georgia Department of Public Health data repository. We used the Granger causality test to assess whether including C19Check data can improve predictions compared to using previous COVID-19 cases and hospitalizations data alone. Vector autoregression (VAR) models were fitted to forecast cases and hospitalizations from November 29 – December 12, 2020. We calculated mean absolute percentage error to estimate the errors in forecast of cases and hospitalizations. Results: There were 25,861 C19Check uses in GA from April 22–November 28, 2020. Time-lags tested in Granger causality test for cases (6–8 days) and hospitalizations (10–12 days) were significant (P=

Introduction: The Allocation System Changes for Equity in Kidney Transplantation (ASCENT) trial was a cluster-randomized pragmatic, effectiveness-implementation study designed to test whether a multicomponent educational intervention targeting leadership, clinic staff, and patients in dialysis facilities improved knowledge and awareness of the 2014 Kidney Allocation System (KAS) change. Methods: Participants included 690 dialysis facility medical directors, nephrologists, social workers, and other staff within 655 US dialysis facilities, with 51% (n = 334) in the intervention group and 49% (n = 321) in the control group. Intervention activities included a webinar targeting medical directors and facility staff, an approximately 10-minute educational video targeting dialysis staff, an approximately 10-minute educational video targeting patients, and a facility-specific audit and feedback report of transplant performance. The control group received a standard United Network for Organ Sharing brochure. Provider knowledge was a secondary outcome of the ASCENT trial and the primary outcome of this study; knowledge was assessed as a cumulative score on a 5-point Likert scale (higher score = greater knowledge). Intention-to-treat analysis was used. Results: At baseline, nonintervention providers had a higher mean knowledge score (mean ± SD, 2.45 ± 1.43) than intervention providers (mean ± SD, 2.31 ± 1.46). After 3 months, the average knowledge score was slightly higher in the intervention (mean ± SD, 3.14 ± 1.28) versus nonintervention providers (mean ± SD, 3.07 ± 1.24), and the estimated mean difference in knowledge scores between the groups at follow-up minus the mean difference at baseline was 0.25 (95% confidence interval [CI], 0.11–0.48; P = 0.039). The effect size (0.41) was low to moderate. Conclusion: Dialysis facility provider education could help extend the impact of a national policy change in organ allocation.

Abstract Background Idiopathic nephrotic syndrome has a relapsing-remitting course in the majority of pediatric patients, demanding vigilant monitoring and self-management. A novel, expert-designed, user-informed mobile application (app), UrApp©, was created to support management tasks, including home urine protein monitoring. Methods The UrApp Pilot Study ( ClinicalTrials.gov , NCT04075656 ) is a randomized trial comparing UrApp-supported nephrotic syndrome management with standard-of-care with parallel process evaluation of the intervention delivery. Sixty caregivers of children with newly diagnosed, steroid-sensitive nephrotic syndrome will be randomized 1:1 to UrApp-supported care or standard-of-care. Follow-up will be 1 year, with primary outcomes of adherence to urine monitoring and medications assessed at 6 and 12 months. Secondary outcomes at 6 and 12 months include self-efficacy, quality-of-life, hospitalizations and delayed relapse diagnoses. A mixed-methods approach will evaluate UrApp engagement, use retention, features used, user perceptions, and contextual barriers and facilitators of UrApp use. User behavior will be assessed for relationships to the primary and secondary outcomes. A Stakeholder Committee of volunteer trial participants, clinicians, and engineers will examine the trial results and design a pragmatic UrApp-enhanced nephrotic syndrome intervention with potential for wide implementation. The final UrApp intervention will be tested in a user-centered hybrid effectiveness-implementation trial designed with stakeholder input. Discussion The UrApp Pilot Study examines the efficacy of a novel app designed specifically for nephrotic syndrome. The protocol involves dual efficacy and process evaluation aims to increase efficiency and incorporates the stakeholders’ perspective in formative assessment to inform intervention redesign and the design of a future user-centered trial. Trial registration ClinicalTrials.gov , NCT04075656 . Registered on September 2, 2019, https://clinicaltrials.gov/ct2/show/NCT04075656

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: Many patients with kidney failure will live longer and healthier lives if they receive a kidney transplant rather than dialysis. However, multiple barriers prevent patients from accessing this treatment option. Objective: To determine if a quality improvement intervention provided in chronic kidney disease (CKD) programs (vs. usual care) enables more patients with no recorded contraindications to kidney transplant to complete more steps toward receiving a kidney transplant. Design: This protocol describes a pragmatic 2-arm, parallel-group, open-label, registry-based, cluster-randomized clinical trial—the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial. Setting: All 26 CKD programs in Ontario, Canada, with a trial start date of November 1, 2017. The original end date of March 31, 2021 (3.4 years) has been extended to December 31, 2021 (4.1 years) due to the COVID-19 pandemic. Participants: During the trial, the 26 CKD programs are expected to care for more than 10 000 adult patients with CKD (including patients approaching the need for dialysis and patients receiving dialysis) with no recorded contraindications to a kidney transplant. Intervention: Programs were randomly allocated to provide a quality improvement intervention or usual care. The intervention has 4 main components: (1) local quality improvement teams and administrative support; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Primary Outcome: The primary outcome is the number of key steps completed toward receiving a kidney transplant analyzed at the cluster level (CKD program). The following 4 unique steps per patient will be counted: (1) patient referred to a transplant center for evaluation, (2) at least one living kidney donor candidate contacts a transplant center for an intended recipient and completes a health history questionnaire to begin their evaluation, (3) patient added to the deceased donor transplant wait list, and (4) patient receives a kidney transplant from a living or deceased donor. Planned Primary Analysis: Study data will be obtained from Ontario’s linked administrative healthcare databases. An intent-to-treat analysis will be conducted comparing the primary outcome between randomized groups using a 2-stage approach. First stage: residuals are obtained from fitting a regression model to individual-level variables ignoring intervention and clustering effects. Second stage: residuals from the first stage are aggregated at the cluster level as the outcome. Limitations: It may not be possible to isolate independent effects of each intervention component, the usual care group could adopt intervention components leading to contamination bias, and the relatively small number of clusters could mean the 2 arms are not balanced on all baseline prognostic factors. Conclusions: The EnAKT LKD trial will provide high-quality evidence on whether a multi-component quality improvement intervention helps patients complete more steps toward receiving a kidney transplant. Trial registration: Clinicaltrials.gov; identifier: NCT03329521.

Introduction: There are pervasive racial disparities in access to living donor kidney transplantation, which for most patients with end-stage renal disease (ESRD) represents the optimal treatment. We previously developed a theory-driven, culturally sensitive intervention for African American (AA) patients with kidney disease called Living ACTS (About Choices in Transplantation and Sharing) as a DVD and booklet, and found this intervention was effective in increasing living donor transplant knowledge. However, it is unknown whether modifying this intervention for a Web-based environment is effective at increasing access to living donor transplantation. Methods: We describe the Web-based Living ACTS study, a multicenter, randomized controlled study designed to test the effectiveness of a revised Living ACTS intervention in 4 transplant centers in the southeastern United States. The intervention consists of a Web site with 5 modules: Introduction, Benefits and Risks, The Kidney Transplant Process, Identifying a Potential Kidney Donor, and ACT Now (which encourages communication with friends and family about transplantation). Results: This study will enroll approximately 800 patients from the 4 transplant centers. The primary outcome is the percentage of patients with at least 1 inquiry from a potential living donor among patients who receive Living ACTS as compared with those who receive a control Web site. Conclusion: The results from this study are expected to demonstrate the effectiveness of an intervention designed to increase access to living donor transplantation among AA individuals. If successful, the Web-based intervention could be disseminated across the >250 transplant centers in the United States to improve equity in living donor kidney transplantation. Keywords: education, intervention, kidney transplant

Abstract Background Readmission within 30 days of hospital discharge is common and costly among end-stage renal disease (ESRD) patients. Little is known about long-term outcomes after readmission. We estimated the association between hospital admissions and readmissions in the first year of dialysis and outcomes in the second year. Methods Data on incident dialysis patients with Medicare coverage were obtained from the United States Renal Data System (USRDS). Readmission patterns were summarized as no admissions in the first year of dialysis (Admit-), at least one admission but no readmissions within 30 days (Admit+/Readmit-), and admissions with at least one readmission within 30 days (Admit+/Readmit+).We used Cox proportional hazards models to estimate the association between readmission pattern and mortality, hospitalization, and kidney transplantation, accounting for demographic and clinical covariates. Results Among the 128,593 Medicare ESRD patients included in the study, 18.5% were Admit+/Readmit+, 30.5% were Admit+/Readmit-, and 51.0% were Admit-. Readmit+/Admit+ patients had substantially higher long-term risk of mortality (HR = 3.32 (95% CI, 3.21–3.44)), hospitalization (HR = 4.46 (95% CI, 4.36–4.56)), and lower likelihood of kidney transplantation (HR = 0.52 (95% CI, 0.44–0.62)) compared to Admit- patients; these associations were stronger than those among Admit+/Readmit- patients. Conclusions Patients with readmissions in the first year of dialysis were at substantially higher risk of poor outcomes than either patients who had no admissions or patients who had hospital admissions but no readmissions. Identifying strategies to both prevent readmission and mitigate risk among patients who had a readmission may improve outcomes among this substantial, high-risk group of ESRD patients.

Abstract Background Home monitoring of urine protein is a critical component of disease management in childhood nephrotic syndrome. We describe the development of a novel mobile application, UrApp – Nephrotic Syndrome Manager, to aid disease monitoring. Methods UrApp was iteratively developed by a panel of two pediatric nephrologists and three research engineers from May 2017 to October 2018 for Apple iPhones. App features were devised by this expert panel to support urine monitoring and other home care tasks. Each feature and user-app interface element was systematically reviewed by the panel and iteratively redesigned to remove anticipated use issues. The app prototype was then refined based on two rounds of usability testing and semi-structured user interviews with a total of 20 caregivers and adolescent patients. The analytic function of UrApp in providing a camera read of the urine test strip was compared to a standard urinalysis machine using 88 patient urine samples and three iPhones, model versions 6S and 7. Exact agreement and weighted kappa were calculated between the UrApp and urinalysis machine reads. Results The final UrApp features include: camera read of a urine test strip; analysis of urine protein trends and alerts for new disease relapse/remission; transmission of urine protein results to providers; education materials; and medication reminders. During the second round of UrApp usability testing, all users were able to perform each of the functions without error and all perceived UrApp to be helpful and indicated that they would use UrApp. UrApp camera results had 97% exact agreement and an overall weighted kappa value of 0.91 (95% CI, 0.85–0.97) compared with standard urinalysis machine interpretation. Conclusions UrApp was specifically designed to support patients and families living with nephrotic syndrome by supporting disease monitoring and home management tasks. The technically innovative feature that makes this possible is the use of a smartphone camera to read the urine test strip. This novel tool has the potential to improve disease monitoring and reduce management burden.

Abstract Background The Reducing Disparities in Access to kidNey Transplantation Community Study (RaDIANT) was an End-Stage Renal Disease (ESRD) Network 6-developed, dialysis facility-level randomized trial testing the effectiveness of a 1-year multicomponent education and quality improvement intervention in increasing referral for kidney transplant evaluation among selected Georgia dialysis facilities. Methods To assess implementation of the RaDIANT intervention, we conducted a process evaluation at the conclusion of the intervention period (January–December 2014). We administered a 20-item survey to the staff involved with transplant education in 67 dialysis facilities randomized to participate in intervention activities. Survey items assessed facility participation in the intervention (fidelity and reach), helpfulness and willingness to continue intervention activities (sustainability), suggestions for improving intervention components (sustainability), and factors that may have influenced participation and study outcomes (context). We defined high fidelity to the intervention as completing 11 or more activities, and high participation in an activity as having at least 75% participation across intervention facilities. Results Staff from 65 of the 67 dialysis facilities completed the questionnaire, and more than half (50.8%) reported high adherence (fidelity) to RaDIANT intervention requirements. Nearly two-thirds (63.1%) of facilities reported that RaDIANT intervention activities were helpful or very helpful, with 90.8% of facilities willing to continue at least one intervention component beyond the study period. Intervention components with high participation emphasized staff and patient-level education, including in-service staff orientations, patient and family education programs, and patient educational materials. Suggested improvements for intervention activities emphasized addressing financial barriers to transplantation, with financial education materials perceived as most helpful among RaDIANT educational materials. Variation in facility-level fidelity of the RADIANT intervention did not significantly influence the mean difference in proportion of patients referred pre- (2013) and post-intervention (2014). Conclusions We found high fidelity to the RaDIANT multicomponent intervention at the majority of intervention facilities, with sustainability of select intervention components at intervention facilities and feasibility for dissemination across ESRD Networks. Future modification of the intervention should emphasize financial education regarding kidney transplantation and amend intervention components that facilities perceive as time-intensive or non-sustainable. Trial registration Clinicaltrials.gov number NCT02092727 . Registered 13 Mar 2014 (retrospectively registered).

Abstract Background Racial/ethnic, gender, and age disparities in access to renal transplantation among end-stage renal disease (ESRD) patients have been well documented, but few studies have explored health care staff attitudes towards these inequalities. Staff perceptions can influence patient care and outcomes, and identifying staff perceptions on disparities could aid in the development of potential interventions to address these health inequities. The objective of this study was to investigate dialysis staff (n = 509), primarily social workers and nurse managers, perceptions of renal transplant disparities in the Southeastern United States. Methods This is a mixed methods study that uses both deductive and inductive qualitative analysis of a dialysis staff survey conducted in 2012 using three open-ended questions that asked staff to discuss their perceptions of factors that may contribute to transplant disparities among African American, female, and elderly patients. Results Study results suggested that the majority of staff (n = 255, 28%) perceived patients’ low socioeconomic status as the primary theme related to why renal transplant disparities exist between African Americans and non-Hispanic whites. Staff cited patient perception of old age as a primary contributor (n = 188, 23%) to the disparity between young and elderly patients. The dialysis staff responses on gender transplant disparities suggested that staff were unaware of differences due to limited experience and observation (n = 76, 14.7%) of gender disparities. Conclusions These findings suggest that dialysis facilities should educate staff on existing renal transplantation disparities, particularly gender disparities, and collaboratively work with transplant facilities to develop strategies to actively address modifiable patient barriers for transplant.

Abstract Urbanization is expected to increase in low and middle-income countries (LMICs), and might contribute to the increased disease burden. The association between urbanization and CKD is incompletely understood among LMICs. Recently, Inoue et al., explored the association of urbanization on renal function from the China Health and Nutrition Survey. The study found that individuals living in an urban environment had a higher odds of reduced renal function independent of behavioral and cardiometabolic measures, and this effect increased in a dose dependent manner. In this commentary, we discuss the results of these findings and explain the need for more surveillance studies among LMICs.

The United Network for Organ Sharing (UNOS) implemented a new Kidney Allocation System (KAS) in December 2014 that is expected to substantially reduce racial disparities in kidney transplantation among waitlisted patients. However, not all dialysis facility clinical providers and end-stage renal disease (ESRD) patients are aware of how the policy change could improve access to transplantation. Methods: We describe the ASCENT (Allocation System Changes for Equity in Kidney Transplantation) study, a randomized, controlled effectiveness-implementation study designed to test the effectiveness of a multicomponent intervention to improve access to the early steps of kidney transplantation among dialysis facilities across the United States. The multicomponent intervention consists of an educational webinar for dialysis medical directors, an educational video for patients and an educational video for dialysis staff, and a dialysis facility−specific transplantation performance feedback report. Materials will be developed by a multidisciplinary dissemination advisory board and will undergo formative testing in dialysis facilities across the United States. Results: This study is estimated to enroll ∼600 US dialysis facilities with low waitlisting in all 18 ESRD networks. The co-primary outcomes include change in waitlisting and waitlist disparity at 1 year; secondary outcomes include changes in facility medical director knowledge about KAS, staff training regarding KAS, patient education regarding transplantation, and the intent of the medical director to refer patients for transplantation evaluation. Discussion: The results from the ASCENT study will demonstrate the feasibility and effectiveness of a multicomponent intervention designed to increase access to the deceased donor kidney waitlist and to reduce racial disparities in waitlisting.

After renal transplantation, decreased renal function is associated with increased risk of cardiovascular disease, graft loss, and mortality. We investigated whether declining renal function was associated with hospitalization after transplantation. Methods: Adult, first-time, kidney transplant recipients between 2004 and 2006 from the United Network for Organ Sharing database and hospitalizations 1 year after the 6-month posttransplant follow-up visit were examined. Generalized linear models explored the relationship between estimated glomerular filtration rate (eGFR) measured at 6 months and the number of hospitalizations in the following year. Results: Of 15,778 kidney transplant recipients, 19.1% were admitted in the year after the 6-month follow-up visit. Among those hospitalized, the mean number of hospitalizations was 1.71, which increased with decreasing eGFR. In multivariable models, a decrease in eGFR was significantly associated with increased hospitalizations: for every 10 ml/min per 1.73 m2 decrease in eGFR, there was an 11% increase in hospitalization rate (P < 0.001). Lower eGFR after the first 6 months after transplantation was associated with an increase in late hospitalizations among adult kidney transplant recipients. Discussion: Identifying patients with declining eGFR and other risk factors may help prevent morbidity and mortality associated with hospitalization after transplantation.

Background: Many patients with end-stage kidney disease (ESKD) do not appreciate how their survival may differ if treated with a kidney transplant compared with dialysis. A risk calculator (iChoose Kidney) developed and validated in the United States provides individualized mortality estimates for different treatment options (dialysis vs living or deceased donor kidney transplantation). The calculator can be used with patients and families to help patients make more educated treatment decisions. Objective: To validate the iChoose Kidney risk calculator in Ontario, Canada. Design: External validation study. Setting: We used several linked administrative health care databases from Ontario, Canada. Patients: We included 22 520 maintenance dialysis patients and 4505 kidney transplant recipients. Patients entered the cohort between 2004 and 2014. Measurements: Three-year all-cause mortality. Methods: We assessed model discrimination using the C-statistic. We assessed model calibration by comparing the observed versus predicted mortality risk and by using smoothed calibration plots. We used multivariable logistic regression modeling to recalibrate model intercepts using a correction factor, when appropriate. Results: In our final version of the iChoose Kidney model, we included the following variables: age (18-80 years), sex (male, female), race (white, black, other), time on dialysis (12 months), and patient comorbidities (hypertension, diabetes, and/or cardiovascular disease). Over the 3-year follow-up period, 33.3% of dialysis patients and 6.2% of kidney transplant recipients died. The discriminatory ability was moderate (C-statistic for dialysis: 0.70, 95% confidence interval [CI]: 0.69-0.70, and C-statistic for transplant: 0.72, 95% CI: 0.69-0.75). The 3-year observed and predicted mortality estimates were comparable and even more so after we recalibrated the intercepts in 2 of our models (dialysis and deceased donor kidney transplantation). As done in the United States, we developed a Canadian Web site and an iOS application called Dialysis vs. Kidney Transplant- Estimated Survival in Ontario. Limitations: Missing data in our databases precluded the inclusion of all variables that were in the original iChoose Kidney (ie, patient ethnicity and low albumin). We were unable to perform all preplanned analyses due to the limited sample size. Conclusions: The original iChoose Kidney risk calculator was able to adequately predict mortality in this Canadian (Ontario) cohort of ESKD patients. After minor modifications, the predictive accuracy improved. The Dialysis vs. Kidney Transplant- Estimated Survival in Ontario risk calculator may be a valuable resource to help ESKD patients make an informed decision on pursuing kidney transplantation.

Kidney transplantation is the preferred treatment for patients with end-stage renal disease, as it substantially increases a patient’s survival and is cost-saving compared to a lifetime of dialysis. However, transplantation is not universally chosen by patients with renal failure, and limited knowledge about the survival benefit of transplantation versus dialysis may play a role. We created a mobile application clinical decision aid called iChoose Kidney to improve access to individualized prognosis information comparing dialysis and transplantation outcomes. Methods: We describe the iChoose Kidney study, a randomized controlled trial designed to test the clinical efficacy of a mobile health decision aid among end-stage renal disease patients referred for kidney transplantation at 3 large, diverse transplant centers across the United States. Approximately 450 patients will be randomized to receive either (i) standard of care or “usual” transplantation education, or (ii) standard of care plus iChoose Kidney. Results: The primary outcome is change in knowledge about the survival benefit of kidney transplantation versus dialysis from baseline to immediate follow-up; secondary outcomes include change in treatment preferences, improved decisional conflict, and increased access to kidney transplantation. Analyses are also planned to examine effectiveness across subgroups of race, socioeconomic status, health literacy, and health numeracy. Discussion: Engaging patients in health care choices can increase patient empowerment and improve knowledge and understanding of treatment choices. If the effectiveness of iChoose Kidney has a greater impact on patients with low health literacy, lower socioeconomic status, and minority race, this decision aid could help reduce disparities in access to kidney transplantation.