Background: In the context of clinical research, investigators have historically selected the outcomes that they consider to be important, but these are often discordant with patients' priorities. Efforts to define and report patient-centered outcomes are gaining momentum, though little work has been done in nephrology. We aimed to identify patient and caregiver priorities for outcomes in hemodialysis.
Study design: Nominal group technique.
Setting & participants: Patients on hemodialysis therapy and their caregivers were purposively sampled from 4 dialysis units in Australia (Sydney and Melbourne) and 7 dialysis units in Canada (Calgary).
Methodology: Identification and ranking of outcomes.
Analytical approach: Mean rank score (of 10) for top 10 outcomes and thematic analysis.
Results: 82 participants (58 patients, 24 caregivers) aged 24 to 87 (mean, 58.4) years in 12 nominal groups identified 68 outcomes. The 10 top-ranked outcomes were fatigue/energy (mean rank score, 4.5), survival (defined by patients as resilience and coping; 3.7), ability to travel (3.6), dialysis-free time (3.3), impact on family (3.2), ability to work (2.5), sleep (2.3), anxiety/stress (2.1), decrease in blood pressure (2.0), and lack of appetite/taste (1.9). Mortality ranked only 14th and was not regarded as the complement of survival. Caregivers ranked mortality, anxiety, and depression higher than patients, whereas patients ranked ability to work higher. Four themes underpinned their rankings: living well, ability to control outcomes, tangible and experiential relevance, and severity and intrusiveness.
Limitations: Only English-speaking participants were eligible.
Conclusions: Although trials in hemodialysis have typically focused on outcomes such as death, adverse events, and biological markers, patients tend to prioritize outcomes that are more relevant to their daily living and well-being. Researchers need to consider interventions that are likely to improve these outcomes and measure and report patient-relevant outcomes in trials, and clinicians may become more patient-orientated by using these outcomes in their clinical encounters.
Keywords: Patient-centered outcomes; caregivers; clinical research priorities; end-stage renal disease (ESRD); fatigue; focus group; hemodialysis; nominal group; outcome measurement; patient wellbeing; patients; qualitative research; quality of life; surrogate end points.
Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.