Abstract: FR-PO1023
Use, Administration, and Interpretation of Patient-Reported Outcome Measures in Dialysis Randomized Controlled Trials: A Systematic Review
Session Information
- Hemodialysis: Clinical Challenges, Patient-Centered Outcomes, and Quality of Life
October 23, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Zdunek, Victoria, Western University, London, Ontario, Canada
- Bu, Shuhan, Western University, London, Ontario, Canada
- Rueda, Maria D., Western University, London, Ontario, Canada
- Leung, Caitlin, Western University, London, Ontario, Canada
- Roshanov, Pavel, Western University, London, Ontario, Canada
Background
Patient-reported outcome measures (PROMs) are increasingly used in dialysis randomized controlled trials (RCTs) to evaluate symptoms and quality of life. However, PROM practices vary considerably across trials, creating challenges for interpretation, comparability, and integration of patient-centred evidence in nephrology. We evaluated how contemporary dialysis RCTs select, administer, analyze, and interpret PROMs, and identified methodological patterns with implications for trial quality.
Methods
We searched seven databases to identify RCTs enrolling individuals receiving maintenance dialysis that reported at least one longitudinal PROM. Screening was restricted to publications from 2021 onward to reflect contemporary practice. Two reviewers independently screened records, assessed full texts, and extracted data in duplicate. Extracted variables included eligibility and retention, instrument choice, administration procedures, measurement timing, analytic methods, and interpretive approaches. Findings were synthesized descriptively and thematically.
Results
We identified 172 eligible RCTs. Trials were small (median 74 participants) with short follow-up (median 3 months) and tended to enroll healthier populations (mean age 57.8); annualized mortality in control arms was low (median 3.4 deaths per 100 patient-years). Most trials used PROMs as secondary outcomes (53.2%). When summarized at the study level, KDQOL instruments were most frequently used (34.3%), followed by the SF-36 26.7%) and EQ-5D (12.8%) although justification for instrument choice was uncommon. Administration procedures were poorly reported: 54.5% of PROM instances provided no information on how instruments were administered. When reported, paper-based administration was most common (25.6%), followed by interviewer/phone administration (14.7%) and electronic administration (5.2%). Although all trials collected PROMs at ≥2 timepoints, 44.3% analyzed them using methods that did not account for within-subject correlation, and 55.2% reported only descriptive summaries or p-values without effect estimates or measures of precision.
Conclusion
PROMs are increasingly included in dialysis RCTs, but substantial variation in selection, administration, and analysis highlights the need for standardized and transparent PROM practices to strengthen patient-centred evidence.