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Article Dans Une Revue American Journal of Kidney Diseases Année : 2017

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

Nicole Evangelidis
  • Fonction : Auteur
Allison Tong
  • Fonction : Auteur
Braden Manns
  • Fonction : Auteur
Brenda Hemmelgarn
  • Fonction : Auteur
David C. Wheeler
  • Fonction : Auteur
Peter Tugwell
Sally Crowe
  • Fonction : Auteur
Tess Harris
  • Fonction : Auteur
Wim van Biesen
  • Fonction : Auteur
Wolfgang C. Winkelmayer
  • Fonction : Auteur
Donal O'Donoghue
  • Fonction : Auteur
Helen Tam-Tham
  • Fonction : Auteur
Sajeda Youssouf
  • Fonction : Auteur
Sreedhar Mandayam
  • Fonction : Auteur
Angela Ju
  • Fonction : Auteur
Carmel Hawley
  • Fonction : Auteur
Carol Pollock
  • Fonction : Auteur
David C. Harris
  • Fonction : Auteur
David W. Johnson
  • Fonction : Auteur
Dena E. Rifkin
  • Fonction : Auteur
Francesca Tentori
  • Fonction : Auteur
John Agar
  • Fonction : Auteur
Kevan R. Polkinghorne
  • Fonction : Auteur
Martin Gallagher
Peter G. Kerr
  • Fonction : Auteur
Stephen P. Mcdonald
  • Fonction : Auteur
Kirsten Howard
  • Fonction : Auteur
Martin Howell
  • Fonction : Auteur
Jonathan C. Craig
  • Fonction : Auteur

Résumé

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~≥q 8, mean score~≥q 7.5, proportion rating the outcome as critically important~≥q 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.

Dates et versions

hal-03158138 , version 1 (03-03-2021)

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Citer

Nicole Evangelidis, Allison Tong, Braden Manns, Brenda Hemmelgarn, David C. Wheeler, et al.. Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey. American Journal of Kidney Diseases, 2017, 70 (4), pp.464-475. ⟨10.1053/j.ajkd.2016.11.029⟩. ⟨hal-03158138⟩
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