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

Evangelidis, N; Tong, A; Manns, B; Hemmelgarn, B; Wheeler, DC; Tugwell, P; Crowe, S; ... Craig, JC; + view all (2017) Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey. American Journal of Kidney Diseases , 70 (4) pp. 464-475. 10.1053/j.ajkd.2016.11.029. Green open access

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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.

Type: Article
Title: Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey
Open access status: An open access version is available from UCL Discovery
DOI: 10.1053/j.ajkd.2016.11.029
Publisher version: http://doi.org/10.1053/j.ajkd.2016.11.029
Language: English
Additional information: © 2017 by the National Kidney Foundation, Inc. This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Science & Technology, Life Sciences & Biomedicine, Urology & Nephrology, Hemodialysis (HD), outcomes, Delphi survey, core outcome set, trials, outcome domains, research priorities, surrogate end points, Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD), quality of life, lifestyle-related outcomes, well-being, biochemical end point, dialysis adequacy, cardiovascular disease (CVD), vascular access problems, mortality, patient-centered care, CHRONIC KIDNEY-DISEASE, LOW-BACK-PAIN, CLINICAL-TRIALS, MIXED-METHODS, PARATHYROID-HORMONE, SYSTEMATIC REVIEWS, FAMILY CAREGIVERS, PROTOCOL, DIALYSIS, PATIENT
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Renal Medicine
URI: https://discovery.ucl.ac.uk/id/eprint/10024529
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