TY - JOUR
T1 - Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey
AU - Evangelidis, Nicole
AU - Tong, Allison
AU - Manns, Braden
AU - Hemmelgarn, Brenda
AU - Wheeler, David
AU - Tugwell, Peter
AU - Crowe, Sally
AU - Harris, Tess
AU - van Biesen, Wim
AU - Winkelmayer, Wolfgang
AU - Sautenet, Benedicte
AU - O’Donoghue, Donal
AU - Tam-Tham, Helen
AU - Youssouf, Sajeda
AU - Mandayam, Sreedhar
AU - Ju, Angela
AU - Hawley, Carmel
AU - Pollock, Carol
AU - Harris, David
AU - Johnson, David
AU - Rifkin, Dena
AU - Tentori, Francesca
AU - Agar, John
AU - Polkinghorne, Kevan
AU - Gallagher, Martin
AU - Kerr, Peter
AU - McDonald, Stephen
AU - Howard, Kirsten
AU - Howell, Martin
AU - Craig, Jonathan
PY - 2017/10
Y1 - 2017/10
N2 - 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.
AB - 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.
KW - biochemical end point
KW - cardiovascular disease (CVD)
KW - core outcome set
KW - Delphi survey
KW - dialysis adequacy
KW - Hemodialysis (HD)
KW - lifestyle-related outcomes
KW - mortality
KW - outcome domains
KW - outcomes
KW - patient-centered care
KW - quality of life
KW - research priorities
KW - Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD)
KW - surrogate end points
KW - trials
KW - vascular access problems
KW - well-being
UR - http://www.scopus.com/inward/record.url?scp=85013627801&partnerID=8YFLogxK
U2 - 10.1053/j.ajkd.2016.11.029
DO - 10.1053/j.ajkd.2016.11.029
M3 - Article
VL - 70
SP - 464
EP - 475
JO - American Journal of Kidney Diseases
JF - American Journal of Kidney Diseases
SN - 0272-6386
IS - 4
ER -