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

Evangelidis, Nicole, Tong, Allison, Manns, Braden, Hemmelgarn, Brenda, Wheeler, David C., Tugwell, Peter, Crowe, Sally, Harris, Tess, Van Biesen, Wim, Winkelmayer, Wolfgang C., Sautenet, Benedicte, O'Donoghue, Donal, Tam-Tham, Helen, Youssouf, Sajeda, Mandayam, Sreedhar, Ju, Angela, Hawley, Carmel, Pollock, Carol, Harris, David C., Johnson, David W., Rifkin, Dena E., Tentori, Francesca, Agar, John, Polkinghorne, Kevan R., Gallagher, Martin, Kerr, Peter G., McDonald, Stephen P., Howard, Kirsten, Howell, Martin, Craig, Jonathan C. and Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Initiative (2017) Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey.. American journal of kidney diseases : the official journal of the National Kidney Foundation, 70 4: 464-475. doi:10.1053/j.ajkd.2016.11.029


Author Evangelidis, Nicole
Tong, Allison
Manns, Braden
Hemmelgarn, Brenda
Wheeler, David C.
Tugwell, Peter
Crowe, Sally
Harris, Tess
Van Biesen, Wim
Winkelmayer, Wolfgang C.
Sautenet, Benedicte
O'Donoghue, Donal
Tam-Tham, Helen
Youssouf, Sajeda
Mandayam, Sreedhar
Ju, Angela
Hawley, Carmel
Pollock, Carol
Harris, David C.
Johnson, David W.
Rifkin, Dena E.
Tentori, Francesca
Agar, John
Polkinghorne, Kevan R.
Gallagher, Martin
Kerr, Peter G.
McDonald, Stephen P.
Howard, Kirsten
Howell, Martin
Craig, Jonathan C.
Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Initiative
Title Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey.
Journal name American journal of kidney diseases : the official journal of the National Kidney Foundation   Check publisher's open access policy
ISSN 1523-6838
Publication date 2017-10-01
Sub-type Article (original research)
DOI 10.1053/j.ajkd.2016.11.029
Open Access Status Not yet assessed
Volume 70
Issue 4
Start page 464
End page 475
Total pages 12
Publisher W.B. Saunders
Language eng
Subject 2727 Nephrology
Abstract 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.

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.

1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3.

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.

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).

The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection.

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.
Keyword Delphi survey
Hemodialysis (HD)
Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD)
biochemical end point
cardiovascular disease (CVD)
core outcome set
dialysis adequacy
lifestyle-related outcomes
mortality
outcome domains
outcomes
patient-centered care
quality of life
research priorities
surrogate end points
trials
vascular access problems
well-being
Q-Index Code C1
Q-Index Status Provisional Code
Grant ID 1098815
1106716
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: Pubmed Import
 
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Created: Wed, 15 Nov 2017, 12:42:38 EST