RATIONALE & OBJECTIVE:Most living kidney donors report normal-to-high self-esteem before donation. Less is known about the longer-term effects of donation on self-esteem, whether certain pre-donation characteristics are associated with lower self-esteem after donation, or how changes in self-esteem are associated with changes in symptoms of depression and anxiety. STUDY DESIGN:Prospective cohort study. SETTING & PARTICIPANTS:Living kidney donors (n=941) were enrolled before donation from 12 Canadian and 5 Australian transplant centers between 2009 and 2014. EXPOSURE:Living kidney donation. OUTCOMES:Self-reported self-esteem was measured using the Rosenberg Self-Esteem Scale (RSES) before donation, 3 months after donation, and then annually for 5 years or until the last follow-up visit (possible scores range from 0-30, with higher scores indicating higher self-esteem). Donors also completed the Beck Depression and Anxiety Inventories at these timepoints. ANALYTICAL APPROACH:Linear and modified Poisson regression models were used to examine whether pre-donation characteristics were associated with lower self-esteem after donation and if changes in self-esteem were associated with changes in symptoms of depression and anxiety. RESULTS:Nearly all donors (98.6%) reported normal-to-high self-esteem before donating (928/941), and only 2-4% had low self-esteem in follow-up (RSES scores <15). On average, donors had a less than 1-point decrement in average self-esteem between pre-donation and follow-up measurements; while these changes were statistically significant, they were not clinically meaningful (all mean changes <5). Donors with RSES scores ≤20 before donation had an approximate 2-point increase in self-esteem in follow-up (P <0.001). More symptoms of depression before donation were associated with lower self-esteem scores 3 months after donation (P = 0.006). An increase in self-esteem scores after donation was associated with concurrent reductions in symptoms of depression and anxiety (P <0.001). LIMITATIONS:We did not examine the association of early recipient allograft failure or death with donor self-esteem. CONCLUSIONS:In this multicenter study of living kidney donors, nearly all donors reported normal-to-high self-esteem before donation and during five years of follow-up. On average, donors with lower self-esteem before donation had a modest increase in self-esteem after donation. Increases in self-esteem after donation were accompanied by modest reductions in symptoms of depression and anxiety.

Background:Caregiver health-related quality of life (HRQOL) and burden are essential considerations for caregivers of older patients with heart failure (HF) undergoing advanced surgical therapies. We aimed to evaluate change in HRQOL and burden from baseline to 2 years following surgery and identify factors associated with HRQOL in caregivers of patients who underwent heart transplantation (HT, with or without pre-transplant mechanical circulatory support [MCS] HT MCS or HT Non-MCS, respectively) or long-term MCS. Methods:Caregivers, recruited from 13 U.S. sites, completed measures of HRQOL (EQ-5D-3L), burden (Oberst Caregiving Burden Scale), and other measures at baseline, 3, 6, 12, 18, and 24 months after patients' surgery. Analyses included multivariable linear mixed effects models. Results:The cohort of 229 caregiver-patient dyads included caregivers for patients who underwent long-term MCS = 99; HT MCS = 55; or HT Non-MCS = 75. Caregivers were median age = 64[59, 68] years, 87% female, 85% White, 98% spouses, and 86% with co-morbidities. Baseline-24 months post-surgery, caregiver EQ-5D-3L visual analog scale average score ranges were high and stable: long-term MCS = 81-83, HT MCS = 84-88, and HT Non-MCS = 84-87, with no significant change within groups nor cross-sectional differences between groups at all time periods. Burden was low-moderate. Caregiver HRQOL was positively associated with caregiver working and caregiver perception that their own health would remain the same/improve over time and negatively associated with >3 caregiver comorbidities, caregiver gastrointestinal disease, caregiver diabetes, and patient obesity. Conclusions:Caregivers had high/stable HRQOL and low-moderate perceptions of burden through the 2-year follow-up, providing important information when preparing caregivers of patients who will undergo advanced surgical therapies.

Background:Kidney transplantation (KT) evaluation is a complex, lengthy process; and living donor KT (LDKT) is the optimal treatment for kidney failure. Interventions at the start of evaluation may improve evaluation completion and LDKT rates. This study tested whether (a) an educational booklet and video (the "Talking About Living Kidney donation" [TALK] intervention) increased evaluation completion and LDKT when delivered under a streamlined KT evaluation program; and (b) if no effects found, explore differential effects by psychosocial/sociocultural factors (e.g., healthcare-related discrimination). Methods:We conducted a randomized-controlled trial of the TALK intervention using permuted block randomization at an urban transplant center. Participants were enrolled 05/2015-06/2018; follow-up through 08/2022. Staff were blinded to block size, not allocation. Fine-Gray proportional hazards models examined intent-to-treat and per-protocol approaches. Primary outcomes were the cumulative incidence of evaluation completion and LDKT receipt. We explored interaction analyses by psychosocial/sociocultural factors and TALK-assignment. Results:Among 1108 participants (574 [52%] TALK, 534 [48%] No-TALK; median age: 59.13 [IQR: 48.92-67.10]; 243 [22%] Black, 783 [71%] White, 82 [7%] Other; 695 [63%] male), TALK did not significantly improve evaluation completion (sub-distribution hazard [SHR]=1.06; 95% CI: 0.92-1.22) or LDKT receipt (SHR=0.83; 95% CI: 0.55-1.25) in intent-to-treat and per-protocol analyses. In exploratory per-protocol analyses, discrimination significantly modified the effect of TALK on evaluation completion (SHR=0.42; 95% CI: 0.29-0.61). The "No-Discrimination" TALK participants had greater evaluation completion than No-TALK (SHR=1.32; 95% CI: 1.10-1.58), but the "Discrimination" TALK participants had lower evaluation completion than No-TALK (SHR=0.56; 95% CI: 0.41-0.77). Conclusions:Despite streamlined care, TALK did not improve evaluation completion or LDKT rates. A significant interaction in the per-protocol analyses for evaluation completion suggests prior healthcare-related discrimination may limit educational intervention effectiveness. Future studies should explore approaches that address systemic barriers and complement, rather than rely on, educational strategies to promote LDKT (ClinicalTrials.gov Identifier: NCT02342119).

Cluster randomized controlled trials (CRTs) are valuable for interventions involving the clinical care team but often require larger sample sizes due to within-cluster correlation and between-cluster variability. The TAKE-IT-TOO pilot study aimed to estimate the intraclass correlation (ICC) necessary for designing a full-scale CRT to improve medication adherence in pediatric kidney transplant recipients. We examined different approaches to summarizing electronically measured adherence and assessed how these choices impact ICC estimation and sample size requirements. In TAKE-IT-TOO, seven centers were randomized to either an adherence-promoting intervention or a healthy-living intervention. Medication adherence was tracked using electronic pillboxes over a 4-week run-in period followed by a 10-week intervention. Variance estimates were calculated using generalized linear mixed models (GLMM) and used to derive ICC values. We compared two methods of summarizing adherence data and estimated the number of clusters and cluster sizes needed to detect an odds ratio of 1.5 between intervention groups across a range of plausible ICC values. The analysis demonstrated that using repeated adherence measures within each participant offered advantages over relying on a single summary measure, improving statistical power. However, large standard errors around variance estimates made precise ICC estimation difficult. Despite this, we identified a plausible range of ICC values and corresponding sample size requirements for future trials. The TAKE-IT-TOO study underscores the challenges of conducting CRTs in small populations and highlights the value of repeated outcome measures for maximizing statistical efficiency in adherence research.

Background:In the United States, streamlining the kidney transplantation (KT) evaluation process may reduce disparities and barriers to KT access. Prior work showed that the Kidney Transplant Fast Track (KTFT) program shortened this process and reduced racial disparities in waitlisting and overall KT. However, within a setting where evaluation-related structural barriers have been addressed, a comprehensive longitudinal evaluation incorporating sociocultural factors (e.g., medical mistrust, healthcare-related discrimination/racism) alongside race/ethnicity as prespecified predictors across multiple KT milestones, including KT type (living [LDKT] and deceased donor KT [DDKT]), has not been performed. Methods:In this secondary analysis, data came from the KTFT study, a prospective KT candidate cohort. Participants were recruited before KT evaluation start (05/2015-06/2018), coinciding with baseline measure collection, then followed via medical record through 08/2022. We used hierarchically-adjusted Fine-Gray proportional hazards models in this exploratory analysis. Results:Among 1108 KT candidates (243 Black, 783 White, 82 Other), medical mistrust was associated with lower cumulative incidence of waitlisting, but no other sociocultural factors were associated with outcomes. Racial and ethnic differences emerged for KT type: Black participants had a greater cumulative incidence of DDKT, and participants categorized as Other race/ethnicity had a lower cumulative incidence of LDKT, relative to White participants. Conclusions:Although KTFT reduced racial/ethnic disparities in waitlisting and overall KT receipt, we identified racial/ethnic differences in LDKT and DDKT. Medical mistrust was a significant barrier to waitlisting. Findings suggest that even when the KT evaluation process is streamlined, sociocultural factors and race/ethnicity may influence KT outcomes.

ABSTRACTBackgroundThe COVID‐19 pandemic led to widespread adoption of virtual communication platforms. Virtual study visits were implemented in the pilot cluster randomized trial (CRT) stage of Teen Adherence in KidnEy transplant Improving Tracking To Optimize Outcomes (TAKE‐IT TOO). The present study aimed to understand study coordinators' perspectives on conducting a behavioral intervention with adolescent kidney transplant recipients using virtual conferencing platforms.MethodsStudy coordinator participants (N = 6) completed questionnaires and participated in a semi‐structured interview that probed comfort with digital technology, issues encountered, and overall perspectives on conducting virtual study visits. Qualitative thematic analysis was used to identify themes and subthemes.ResultsParticipants expressed confidence with technology and ability to handle the complexities of the virtual conferencing. Some expressed that virtual study visits led to a change in work habits and higher workload due to increased technology complexity. Qualitative analyses of participant interviews revealed four themes: adaptability, accessibility, logistics (including subthemes scheduling and fluidity), and communication (including subthemes clarity, engagement, and rapport). Convenience for coordinators and the perceived comfort for adolescents were noted advantages for virtual visits. Technical issues, periodic adolescent distractions, and challenges with instructional teaching through virtual conferencing were identified as potential limitations of virtual study visits.ConclusionsOverall, virtual study visits were appreciated and endorsed by study coordinators. Researchers should consider the feasibility of completing study‐related tasks virtually, including accessibility of visual materials on all type of electronic devices, and ensure adequate training of study personnel when deciding to implement virtual platform in CRTs.

Importance:Kidney transplant (KT) is the optimal treatment for end-stage kidney disease (ESKD). The evaluation process for KT is lengthy, time-consuming, and burdensome, and racial and ethnic disparities persist. Objective:To investigate the potential association of the Kidney Transplant Fast Track (KTFT) evaluation approach with the likelihood of waitlisting, KT, and associated disparities compared with standard care. Design, Setting, and Participants:This nonrandomized clinical trial was a prospective comparative cohort trial with a historical control (HC) comparison and equal follow-up duration at a single urban transplant center. Study duration was 2015 to 2018 for KTFT, with follow-up through 2022, and 2010 to 2014 for HC, with follow-up through 2018. Adult, English-speaking patients with ESKD, no history of KT, and a scheduled KT evaluation appointment were included. Among 1472 eligible patients for the KTFT group, 1288 consented and completed the baseline interview and 170 were excluded for not attending an evaluation appointment; among 1337 patients eligible for the HC group, 1152 consented and completed the baseline interview and none were excluded. Data were analyzed from August 2023 through December 2024. Exposure:Streamlined, patient-centered, coordinated-care KT evaluation process. Main Outcomes and Measures:Time to waitlisting for KT and receipt of KT. Results:The study included 1118 participants receiving KTFT (416 female [37.2%]; mean [SD] age, 57.2 [13.2] years; 245 non-Hispanic Black [21.9%], 790 non-Hispanic White [70.7%], and 83 other race or ethnicity [7.4%]) and 1152 participants in the HC group (447 female [38.8%]; mean [SD] age, 55.5 [13.2] years; 267 non-Hispanic Black [23.2%], 789 non-Hispanic White [68.5%], and 96 other race or ethnicity [8.3%]). After adjusting for demographic and clinical factors, the KTFT compared with the HC group had a higher likelihood of being placed on the active waitlist for KT (subdistribution hazard ratio [SHR], 1.40; 95% CI, 1.24-1.59). Among individuals who were waitlisted, patients in the KTFT vs HC group had a higher likelihood of receiving a KT (SHR, 1.21; 95% CI, 1.04-1.41). Black patients (SHR, 1.54; 95% CI, 1.11-2.14) and White patients (SHR, 1.38; 95% CI, 1.16-1.65) receiving KTFT were more likely to be waitlisted for KT than those in the HC group, but no such difference was found for patients with other race or ethnicity. Among Black patients, those with KTFT were more likely than those in the HC group to undergo KT (SHR, 1.52; 95% CI, 1.06-2.16), but no significant differences were found for White patients or those with other race or ethnicity. Conclusions and Relevance:This study found that KTFT was associated with a higher likelihood of waitlisting and KT than standard care. Findings suggest that KTFT may be associated with reduced disparities in KT by race and ethnicity. Trial Registration:ClinicalTrials.gov Identifier: NCT02342119.

Allogeneic hematopoietic cell transplantation (HCT) can be a lifesaving treatment for patients with hematologic disease. However, adherence to the post-HCT clinical regimen has many challenges that patients and their family caregivers must manage after hospital discharge. To address their needs, we developed a Dyadic Problem-Solving Therapy (DPST) intervention, then examined its feasibility and acceptability to patients and their family caregivers. Twelve patient-family caregiver dyads participated. Four dyads received DPST in person, four received it via online video conferencing. Another four received an enhanced usual care (EUC) intervention of the same length. Feasibility was assessed using completion rates, while acceptability was assessed using satisfaction ratings on the Client Satisfaction Questionnaire. DPST and EUC were both feasible (100% of dyads who started the intervention completed it) and acceptable with satisfaction ratings ranging from 3.6 to 4 for patients and 3.6-3.9 for family caregivers on a 1-4 scale for both DPST groups and ranging from 3.3 to 3.8 for EUC patients and 3.5-4 for EUC family caregivers. There were no evident differences by mode of intervention delivery. DPST, both in person and via video, appears feasible and acceptable for training patient-family caregiver dyads to manage challenges to adherence to the post-HCT regimen.

Importance The kidney transplant (KT) evaluation process is particularly time consuming and burdensome for Black patients, who report more discrimination, racism, and mistrust in health care than White patients. Whether alleviating patient burden in the KT evaluation process may improve perceptions of health care and enhance patients' experiences is important to understand. Objective To investigate whether Black and White participants would experience improvements in perceptions of health care after undergoing a streamlined, concierge-based approach to KT evaluation. Design, Setting, and Participants This prospective cohort study from a single urban transplant center included Black and White English-speaking adults who were referred for KT and deemed eligible to proceed with the KT evaluation process. The patients responded to baseline and follow-up questionnaires. The study was conducted from May 2015 to June 2018. Questionnaires were collected before KT evaluation initiation (baseline) and after KT evaluation completion (follow-up). Data were analyzed from October 2022 to January 2024. Exposure Data were stratified by race (Black compared with White) and time (baseline compared with follow-up). Main Outcomes and Measures The main outcomes were experiences of discrimination in health care, perceived racism in health care, medical mistrust of health care systems, and trust in physician. Repeated-measures regression was used to assess race, time, and the race-by-time interaction as factors associated with each outcome. Results The study included 820 participants (mean [SD] age, 56.50 [12.93] years; 514 [63%] male), of whom 205 (25%) were Black and 615 (75%) were White. At baseline and follow-up, Black participants reported higher discrimination (119 [58%]; chi 21 = 121.89; P < .001 and 77 [38%]; chi 21 = 96.09; P < .001, respectively), racism (mean [SD], 2.73 [0.91]; t290.46 = 7.77; P < .001 and mean [SD], 2.63 [0.85]; t296.90 = 7.52; P < .001, respectively), and mistrust (mean [SD], 3.32 [0.68]; t816.00 = 7.29; P < .001 and mean [SD], 3.18 [0.71]; t805.00 = 6.43; P < .001, respectively) scores but lower trust in physician scores (mean [SD], 3.93 [0.65]; t818.00 = -2.01; P = .04 and mean [SD], 3.78 [0.65]; t811.00 = -5.42; P < .001, respectively) compared with White participants. All participants experienced statistically significant reductions in discrimination (Black participants: odds ratio, 0.27 [95% CI, 0.16-0.45]; P < .001; White participants: odds ratio, 0.37 [95% CI, 0.25-0.55]; P < .001) and medical mistrust in health care (Black participants: beta [SE], -0.16 [0.05]; P < .001; White participants: beta [SE], -0.09 [0.03]; P < .001), and Black participants reported lower perceived racism at follow-up (beta [SE], -0.11 [0.05]; P = .04). There was a statistically significant race-by-time interaction outcome in which Black participants' trust in physicians was significantly lower at follow-up, but White participants reported no change. Conclusions and Relevance The findings of this cohort study of patients who underwent a streamlined, concierge-based KT evaluation process suggest that a streamlined approach to clinic-level procedures may improve patients' perceptions of the health care system but may not improve their trust in physicians. Future research should determine whether these factors are associated with KT outcome, type of KT received, and time to KT.

BACKGROUND:The quality-adjusted life year (QALY) measures disease burden and treatment, combining overall survival and health-related quality of life (HRQOL). We estimated QALYs in 3 groups of older patients (60-80 years) with heart failure (HF) who underwent heart transplantation (HT, with pre-transplant mechanical circulatory support [HT MCS] or HT without pre-transplant MCS [HT Non-MCS]) or long-term MCS (destination therapy). We also identified factors associated with gains in QALYs through 24 months follow-up. METHODS:Of 393 eligible patients enrolled (10/1/15-12/31/18) at 13 U.S. sites, 161 underwent HT (n = 68 HT MCS, n = 93 HT Non-MCS) and 144 underwent long-term MCS. Survival and HRQOL data were collected through 24 months. QALY health utilities were based on patient self-report of EQ-5D-3L dimensions. Mean-restricted QALYs were compared among groups using generalized linear models. RESULTS:For the entire cohort, mean age in years closest to surgery was 67 (standard deviation, SD: 4.7), 78% were male, and 83% were White. By 18 months post-surgery, sustained significant differences in adjusted average ± SD QALYs emerged across groups, with the HT Non-MCS group having the highest average QALYs (24-month window: HT Non-MCS = 22.58 ± 1.1, HT MCS = 19.53 ± 1.33, Long-term MCS = 19.49 ± 1.3, p = 0.003). At 24 months post-operatively, a lower gain in QALYs was associated with HT MCS, long-term MCS, a lower pre-operative LVEF, NYHA class III or IV before surgery, and an ischemic or other etiology of HF. CONCLUSIONS:Determination of QALYs may provide important information for policy makers and clinicians to consider regarding benefits of HT and long-term MCS as treatment options for older patients with HF.

Background Post-transplant health-related quality of life (HRQOL) is associated with health outcomes for kidney transplant (KT) recipients. However, pretransplant predictors of improvements in post-transplant HRQOL remain incompletely understood. Namely, important pretransplant cultural factors, such as experience of discrimination, perceived racism in healthcare, or mistrust of the healthcare system, have not been examined as potential HRQOL predictors. Also, few have examined predictors of decline in HRQOL post-transplant. Methods Using data from a prospective cohort study, we examined HRQOL change pre- to post-transplant, and novel cultural predictors of the change. We measured physical, mental, and kidney-specific HRQOL as outcomes, and used cultural factors as predictors, controlling for demographic, clinical, psychosocial, and transplant knowledge covariates. Results Among 166 KT recipients (57% male; mean age 50.6 years; 61.4% > high school graduates; 80% non-Hispanic White), we found mental and physical, but not kidney-specific, HRQOL significantly improved post-transplant. No culturally related factors outside of medical mistrust significantly predicted change in any HRQOL outcome. Instead, demographic, knowledge, and clinical factors significantly predicted decline in each HRQOL domain: physical HRQOL-older age, more post-KT complications, higher pre-KT physical HRQOL; mental HRQOL-having less information pre-KT, greater pre-KT mental HRQOL; and, kidney-specific HRQOL-poorer kidney functioning post-KT, lower expectations for physical condition to improve, and higher pre-KT kidney-specific HRQOL. Conclusions Instead of cultural factors, predictors of HRQOL decline included demographic, knowledge, and clinical factors. These findings are useful for identifying patient groups that may be at greater risk of poorer post-transplant outcomes, in order to target individualized support to patients.