TY - JOUR
T1 - Development of an international Delphi survey to establish core outcome domains for trials in adults with glomerular disease
AU - Carter, Simon A.
AU - Logeman, Charlotte
AU - Howell, Martin
AU - Cattran, Dan
AU - Lightstone, Liz
AU - Bagga, Arvind
AU - Barbour, Sean J.
AU - Barratt, Jonathan
AU - Boletis, John
AU - Caster, Dawn J.
AU - Coppo, Rosanna
AU - Fervenza, Fernando C.
AU - Floege, Jürgen
AU - Hladunewich, Michelle A.
AU - Hogan, Jonathan J.
AU - Kitching, A. Richard
AU - Lafayette, Richard A.
AU - Malvar, Ana
AU - Radhakrishnan, Jai
AU - Rovin, Brad H.
AU - Scholes-Robertson, Nicole
AU - Trimarchi, Hérnan
AU - Zhang, Hong
AU - Cho, Yeoungjee
AU - Dunn, Louese
AU - Gipson, Debbie S.
AU - Liew, Adrian
AU - Sautenet, Benedicte
AU - Viecelli, Andrea K.
AU - Harris, David
AU - Johnson, David W.
AU - Wang, Angela Yee Moon
AU - Teixeira-Pinto, Armando
AU - Alexander, Stephen I.
AU - Martin, Adam
AU - Tong, Allison
AU - Craig, Jonathan C.
N1 - Publisher Copyright:
© 2021 International Society of Nephrology
PY - 2021/10
Y1 - 2021/10
N2 - Outcomes relevant to treatment decision-making are inconsistently reported in trials involving glomerular disease. Here, we sought to establish a consensus-derived set of critically important outcomes designed to be reported in all future trials by using an online, international two-round Delphi survey in English. To develop this, patients with glomerular disease, caregivers and health professionals aged 18 years and older rated the importance of outcomes using a Likert scale and a Best-Worst scale. The absolute and relative importance was assessed and comments were analyzed thematically. Of 1198 participants who completed Round 1, 734 were patients/caregivers while 464 were health care professionals from 59 countries. Of 700 participants that completed Round 2, 412 were patients/caregivers and 288 were health care professionals. Need for dialysis or transplant, kidney function, death, cardiovascular disease, remission-relapse and life participation were the most important outcomes to patients/caregivers and health professionals. Patients/caregivers rated patient-reported outcomes higher while health care professionals rated hospitalization, death and remission/relapse higher. Four themes explained the reasons for their priorities: confronting death and compounded suffering, focusing on specific targets in glomerular disease, preserving meaning in life, and fostering self-management. Thus, consistent reporting of these critically important outcomes in all trials involving glomerular disease is hoped to improve patient-centered decision-making.
AB - Outcomes relevant to treatment decision-making are inconsistently reported in trials involving glomerular disease. Here, we sought to establish a consensus-derived set of critically important outcomes designed to be reported in all future trials by using an online, international two-round Delphi survey in English. To develop this, patients with glomerular disease, caregivers and health professionals aged 18 years and older rated the importance of outcomes using a Likert scale and a Best-Worst scale. The absolute and relative importance was assessed and comments were analyzed thematically. Of 1198 participants who completed Round 1, 734 were patients/caregivers while 464 were health care professionals from 59 countries. Of 700 participants that completed Round 2, 412 were patients/caregivers and 288 were health care professionals. Need for dialysis or transplant, kidney function, death, cardiovascular disease, remission-relapse and life participation were the most important outcomes to patients/caregivers and health professionals. Patients/caregivers rated patient-reported outcomes higher while health care professionals rated hospitalization, death and remission/relapse higher. Four themes explained the reasons for their priorities: confronting death and compounded suffering, focusing on specific targets in glomerular disease, preserving meaning in life, and fostering self-management. Thus, consistent reporting of these critically important outcomes in all trials involving glomerular disease is hoped to improve patient-centered decision-making.
KW - consensus
KW - glomerulonephritis
KW - patient outcome assessment
KW - treatment outcome
KW - trials
UR - http://www.scopus.com/inward/record.url?scp=85107386267&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85107386267&partnerID=8YFLogxK
U2 - 10.1016/j.kint.2021.04.027
DO - 10.1016/j.kint.2021.04.027
M3 - Article
C2 - 33964313
AN - SCOPUS:85107386267
SN - 0085-2538
VL - 100
SP - 881
EP - 893
JO - Kidney international
JF - Kidney international
IS - 4
ER -