Impact of Expanded Hemodialysis on Subjective Experience Using Dynamic Patient-Reported Outcome Measurement Tool.

Rationale & Objectives: Current hemodialysis (HD), using conventional high-flux dialyzers, is handicapped by clearance limitations, contributing to poor health-related quality of life (HRQoL) and symptom burden. Recent international consensus guideline-setting efforts have prioritized the identification and management of symptoms and subjective experience, while acknowledging the lack of appropriate tools available to fully appreciate and continuously monitor symptoms. Study Design: Multicenter interventional trial. Setting & Participants: Forty-seven patients undergoing established, conventional, thrice weekly HD in 2 centers in Ontario, Canada. Interventions: Fifteen-month study with the following 5 phases: (1) 1 month observation (high-flux HD), (2) 3 months expanded hemodialysis (HDx); (3) 2 months wash-out (high-flux HD), (4) 6 months HDx, (5) 3 months wash-out (high-flux HD). HRQoL and symptom burden were evaluated using a dynamic patient-reported outcome measurement (PROM) tool throughout the study. Outcomes: This study aimed to use a dynamic PROM to interrogate patient experience and confirm HRQoL and symptom benefit of expanded hemodialysis (HDx) using a medium cutoff dialyzer. The durability of the effects of treatment and variability of symptom measures were analyzed, with the aim to further establish causality through withdrawal and reintroduction of therapy. Results: HDx therapy improved HRQoL (19% from baseline) and a variety of symptoms including general wellbeing (23%), energy (33%), sleep quality (33%), pruritus (30%), pain (19%), restless leg syndrome (15%), mood (12%), appetite (9%), breathlessness (9%), and HD recovery (26%). Response was more pronounced in those with poorer HRQoL and higher symptom burden. Improvements were durable over time with less symptom variability. Improvement diminished with return to high-flux HD. Drivers of poor HRQoL were largely general wellbeing, energy, sleep quality, pruritus, and bodily pain. Limitations: Relatively small cohort (because of pandemic restrictions) and unblinded design (partially overcome with wash-out and reintroduction). Conclusions: Use of a dynamic PROM effectively evaluated HRQoL, symptom burden, and response to treatment in HD patients. Use of HDx therapy improved clinically meaningful outcomes with durable effect and was associated with less variability in important symptom domains than conventional high-flux HD.