Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey

Nicole Evangelidis, Allison Tong, Braden Manns, Brenda Hemmelgarn, David Wheeler, Peter Tugwell, Sally Crowe, Tess Harris, Wim van Biesen, Wolfgang Winkelmayer, Benedicte Sautenet, Donal O’Donoghue, Helen Tam-Tham, Sajeda Youssouf, Sreedhar Mandayam, Angela Ju, Carmel Hawley, Carol Pollock, David Harris, David JohnsonDena Rifkin, Francesca Tentori, John Agar, Kevan Polkinghorne, Martin Gallagher, Peter Kerr, Stephen McDonald, Kirsten Howard, Martin Howell, Jonathan Craig

Research output: Contribution to journalArticlepeer-review

94 Citations (Scopus)

Abstract

Background Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis. Study Design In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents’ scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated. Setting & Participants 1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3. Outcomes & Measurements Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10. Results Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively). Limitations The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection. Conclusions Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions.

Original languageEnglish
Pages (from-to)464-475
Number of pages12
JournalAmerican Journal of Kidney Diseases
Volume70
Issue number4
DOIs
Publication statusPublished - 2017

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