Le Hong Ngoc Pham

Key Points: Coverage of patient characteristics in existing trials of hemodiafiltration versus hemodialysis seems to be broad but incomplete. Randomized trials of hemodiafiltration versus hemodialysis have been primarily limited to Europe. Inconsistencies between trials and registries support further studies using real-world data to explore applicability of existing evidence. Background: Selection criteria in randomized trials (randomized controlled trials [RCTs]) can lead to differences in key characteristics between trial participants and real-life populations. We evaluated reporting of population characteristics in existing RCTs of hemodiafiltration (HDF) and in real-life populations included in kidney registries to descriptively identify key differences. Methods: We used systematic review methodology to identify existing RCTs of HDF versus hemodialysis (1966 to May 2024). We also searched the Fresenius Quantitative Market Analysis team registry database (2024 update) for existing registries from Europe, the Asia-Pacific region, and America including populations on HDF. Patient characteristics from RCTs and registries were extracted, summarized, and compared descriptively. Results: Eleven RCTs ( N =5108) and eight registries ( N =1,147,167) were identified. There were no RCTs in the United States and only two small RCTs from Australia ( N =124) and Brazil ( N =195). Most trials were from Europe. Key characteristics consistently reported in both RCTs and registries were only age, sex, diabetes, cardiovascular disease, vascular access type, and dialysis vintage. There was moderate to high heterogeneity for these patient characteristics in RCTs, indicating enrollment of a broad array of people. The proportion of people with diabetes was 26% in RCTs and 43% in registries. The prevalence of arteriovenous fistulas/graft was 90% in RCTs and 70% in registries. Conclusions: There was a broad but incomplete array of patient characteristics in existing RCTs and real-world registries of HDF versus hemodialysis. Data were primarily limited to Europe and only a core set of demographic and clinical variables. Apart for age, sex, diabetes, cardiovascular disease, vascular access type, and dialysis vintage, other patient and treatment relevant characteristics were erratically or not at all reported in RCTs as well as in real-world registries. With potential differences in patient populations, we support the need for studies examining HDF in real-world settings, e.g ., with target emulation trials.

Key Points: Health-related quality of life in dialysis depends on many nonclinical factors. Psychosocial determinants contribute to explaining variance in health-related quality-of-life domains better than demographic and medical variables alone. In comparison with past small-scale studies, self-efficacy showed significant associations with all aspects of health-related quality of life. Background: We investigated whether psychosocial determinants self-efficacy and social support are associated with health-related quality of life in patients on hemodialysis enrolled in the CONVINCE trial. Methods: We used baseline data from the cohort of patients involved in the CONVINCE randomized trial of hemodiafiltration versus hemodialysis. Measures included age, sex, relationship status, children, housing, education, employment, comorbidities, dialysis schedules, time of first dialysis, residual kidney function, general self-efficacy and social support scores, and Patient-Reported Outcomes Measurement Information System measurements for health-related quality of life. Associations were analyzed using hierarchical regression. Results: One thousand three hundred sixty patients from the CONVINCE trial were the cohort of interest. The mean age was 62±13.5 years (range, 20–92), and 66.9% were male. Self-efficacy was a significant predictor for all health-related quality-of-life domains: depression (β=−0.36, P < 0.001), anxiety (β=−0.35, P < 0.001), social participation (β=0.32, P < 0.001), cognition (β=0.29, P < 0.001), fatigue (β=−0.29, P < 0.001), physical function (β=0.27, P < 0.001), sleep disturbance (β=−0.23, P < 0.001), pain interference (β=0.21, P < 0.001), pain intensity (β=−0.17, P < 0.001), interdialytic symptoms (β=−0.14, P = 0.002), and intradialytic symptoms (β=−0.14, P = 0.002). Social support was a significant predictor for cognition (β=0.21, P < 0.001), sleep disturbance (β=−0.11, P = 0.017), and intradialytic symptoms (β=−0.11, P = 0.02). Conclusions: Higher general self-efficacy scale scores are associated with improvements in cognition, depression, anxiety, social participation, fatigue, physical function, sleep disturbance, pain interference, interdialytic symptoms, pain intensity, and intradialytic symptoms. Associations for self-efficacy are larger than those for social support and stronger than previously reported. It is plausible that targeted psychosocial interventions may improve health outcomes in people on hemodialysis. Podcast: This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/K360/2025_01_30_KID0000000599.mp3