Significance Statement: Reliable, valid, and interpretable patient-reported outcome measures for kidney patients are needed for patient monitoring and use as outcomes in clinical trials. The Kidney Disease Quality of Life 36-item short form survey (KDQOL-36) is often used with patients on dialysis, but improvements are needed to facilitate interpretability of its scores. The authors calculate normative values for the KDQOL-36 scales referenced to the United States dialysis population, which allow comparison of group means and individual scores with national averages, such as by dialysis centers when fulfilling their required annual assessment of patients’ quality of life. The authors also created the KDQOL-36 Summary Score (KSS), a composite of items from the KDQOL-36’s kidney-targeted scales, which may be useful when kidney-targeted health-related quality of life needs to be summarized in a single score. Background: The Kidney Disease Quality of Life 36-item short form survey (KDQOL-36) is a widely used, patient-reported outcome measure for patients on dialysis. Efforts to aid interpretation are needed. Methods: We used a sample of 58,851 dialysis patients participating in the Medical Education Institute (MEI) KDQOL Complete program, and 443,947 patients from the US Renal Data System (USRDS) to develop the KDQOL-36 Summary Score (KSS) for the kidney-targeted KDQOL-36 scales (Burdens of Kidney Disease [BKD], Symptoms and Problems of Kidney Disease [SPKD], and Effects of Kidney Disease [EKD]). We also used the MEI and USRDS data to calculate normative values for the Short Form-12 Health Survey’s Physical Component Summary (PCS) and Mental Component Summary (MCS), and the KDQOL-36’s BKD, SPKD, and EKD scales for the United States dialysis population. We used confirmatory factor analysis (CFA) models for KDQOL-36 kidney-targeted items, evaluated model fit with the comparative fit index (CFI; >0.95 indicates good fit) and root-mean-squared error of approximation (RMSEA; <0.06 indicates good fit), and estimated norms by matching the joint distribution of patient characteristics in the MEI sample to those of the USRDS sample. Results: A bifactor CFA model fit the data well (RMSEA=0.046, CFI=0.990), supporting the KSS (α=0.91). Mean dialysis normative scores were PCS=37.8 and MCS=50.9 (scored on a T-score metric); and KSS=73.0, BKD=52.8, SPKD=79.0, and EKD=74.1 (0–100 possible scores). Conclusions: The KSS is a reliable summary of the KDQOL-36. The United States KDQOL-36 normative facilitate interpretation and incorporation of patient-related outcome measures into kidney disease care.

PURPOSE: Despite defined grades of 1 to 5 for adverse events (AEs) on the basis of Common Terminology Criteria for Adverse Events criteria, mild (G1) and moderate (G2) AEs are often not reported in phase III trials. This under-reporting may inhibit our ability to understand patient toxicity burden. We analyze the relationship between the grades of AEs experienced with patient side-effect bother and treatment discontinuation . METHODS: We analyzed a phase III Eastern Cooperative Oncology Group-American College of Radiology Imaging Network trial with comprehensive AE data. The Likert response Functional Assessment of Cancer Therapy-GP5 item, “I am bothered by side effects of treatment” was used to define side-effect bother. Bayesian mixed models were used to assess the impact of G1 and G2 AE counts on patient side-effect bother and treatment discontinuation. AEs were further analyzed on the basis of symptomatology (symptomatic or asymptomatic). The results are given as odds ratios (ORs) and 95% credible interval (CrI). RESULTS: Each additional G1 and G2 AEs experienced during a treatment cycle increased the odds of increased self-reported patient side-effect bother by 13% (95% CrI, 1.06 to 1.21) and 35% (95% CrI, 1.19 to 1.54), respectively. Furthermore, only AEs defined as symptomatic were associated with increased side-effect bother, with asymptomatic AEs showing no association regardless of grade. Count of G2 AEs increased the odds of treatment discontinuation by 59% (95% CrI, 1.32 to 1.95), with symptomatic G2 AEs showing a stronger association (OR, 1.75; 95% CrI, 1.28 to 2.39) relative to asymptomatic G2 AEs (OR, 1.45; 95% CrI, 1.12 to 1.89). CONCLUSION: Low- and moderate-grade AEs are related to increased odds of increased patient side-effect bother and treatment discontinuation, with symptomatic AEs demonstrating greater magnitude of association than asymptomatic. Our findings suggest that limiting AE capture to grade 3+ misses important contributors to treatment side-effect bother and discontinuation.

Dialysis centers must provide transplant education to patients but often do not address the risks and benefits of living and deceased donor transplant. In a group randomized controlled trial of 20 dialysis centers and 253 patients, we assessed whether the Explore Transplant education program increased patients’ readiness to pursue transplant, transplant knowledge, informed transplant decision-making, discussions about transplant with potential living donors, pursuit and receipt of living or deceased donor transplant, and whether these effects varied by race. Patients at participating dialysis centers were randomized to receive either (1) a 4-module Explore Transplant education program, including videos, printed materials, and transplant educator discussions or (2) standard-of-care transplant education provided by dialysis centers. The trial had 3 phases: (1) pre- and postsurveying and dialysis center education (2007-2008), (2) follow-up to determine whether patients restarted or began transplant evaluation (2008-2010), and (3) assessment of participants’ receipt of a renal transplant (2012-2015). Compared to patients in standard-of-care dialysis centers, patients who received the intervention were more likely to increase in their stage of readiness for living donor transplantation (odds ratio: 2.50; 95% confidence interval: 1.10-5.66), had greater increases in their transplant knowledge (P < .001), and were more likely to call to restart/begin transplant evaluation (38% vs 24%, P = .006). When analyses were stratified by race, black patients were more likely to take several steps toward transplant in comparison to whites. The Explore Transplant helps dialysis patients make informed decisions and increases their pursuit of transplant, particularly among black patients.