Impact of Expanded Hemodialysis Using Medium Cut-off Dialyzer on Quality of Life: Application of Dynamic Patient-Reported Outcome Measurement Tool

Rationale & Objective Current hemodialysis (HD) treatments have limited ability to clear larger molecular weight uremic toxins. Retention is associated with increased symptom burden, low health-related quality of life (HR-QoL) and high mortality. Improved clearance, using novel medium cut-off dialyzers, termed expanded dialysis (HDx) may be associated with improved subjective experience. We have previously developed a dynamic patient reported outcome measure (PROM) instrument, to allow iterative recording to better appreciate the overall burden of disease and assess the impact of therapy changes. Study Design Single-centre interventional pilot study Setting & Participants Twenty-eight patients established on maintenance HD - London, Ontario, Canada. Intervention Initial study consisting of two-week observation (baseline-conventional high-flux HD), followed by 12-weeks HDx. HR-QoL was assessed using dynamic PROM instrument thrice weekly (enabled in a dedicated app as the London Evaluation of Illness-LEVIL). Extension phase – two-week baseline with 24-weeks HDx and eight-week wash-out. Outcomes Principal aim was to establish if HDx therapy was associated with improved HR-QoL, evidence of dose dependant response and if effects were durable over time;utilizing LEVIL. Results Patients with lower LEVIL scores (<70/100) at baseline showed improvement in overall HR-QoL after eight-weeks of therapy with similar carry-over effect. General wellbeing, energy and sleep quality were improved significantly as a consequence of HDx therapy. There were no detrimental effects of HDx detected in patients with higher baseline HR-QoL. Limitations Small non-randomized sample size. COVID-19 pandemic interfered with extension phase. Conclusions Dynamic PROM assessment effectively identified patients with lower HR-QoL and higher symptom burden, demonstrating durable time/dose-dependent improvements across a range of symptom domains. The use of this instrument may allow targeted selection of patients most likely to benefit from HDx therapy and assist in monitoring response and defining effect-size and treatment duration to allow optimal design of further definitive randomized controlled trials of this newly introduced technology.