TY - JOUR
T1 - Outcomes for clinical trials involving adults with chronic kidney disease
T2 - a multinational Delphi survey involving patients, caregivers and health professionals
AU - Gonzalez, Andrea Matus
AU - Evangelidis, Nicole
AU - Howell, Martin
AU - Jaure, Allison
AU - Sautenet, Benedicte
AU - Madero, Magdalena
AU - Ashuntantang, Gloria
AU - Anumudu, Samaya
AU - Bernier-Jean, Amelie
AU - Dunn, Louese
AU - Cho, Yeoungjee
AU - Sanabria, Laura Cortes
AU - de Boer, Ian H.
AU - Fung, Samuel
AU - Gallego, Daniel
AU - Guha, Chandana
AU - Levey, Andrew S.
AU - Levin, Adeera
AU - Lorca, Eduardo
AU - Okpechi, Ikechi G.
AU - Rossignol, Patrick
AU - Scholes-Robertson, Nicole
AU - Sola, Laura
AU - Teixeira-Pinto, Armando
AU - Usherwood, Tim
AU - Viecelli, Andrea K.
AU - Wheeler, David C.
AU - Widders, Katherine
AU - Wilkie, Martin
AU - Craig, Jonathan C.
PY - 2024/8
Y1 - 2024/8
N2 - Background. Many outcomes of high priority to patients and clinicians are infrequently and inconsistently reported across trials in chronic kidney disease (CKD), which generates research waste and limits evidence-informed decision making. We aimed to generate consensus among patients/caregivers and health professionals on critically important outcomes for trials in CKD prior to kidney failure and the need for kidney replacement therapy, and to describe the reasons for their choices. Methods. This was an online two-round international Delphi survey. Adult patients with CKD (all stages and diagnoses), caregivers and health professionals who could read English, Spanish or French were eligible. Participants rated the importance of outcomes using a Likert scale (7–9 indicating critical importance) and a Best–Worst Scale. The scores for the two groups were assessed to determine absolute and relative importance. Comments were analysed thematically. Results. In total, 1399 participants from 73 countries completed Round 1 of the Delphi survey, including 628 (45%) patients/caregivers and 771 (55%) health professionals. In Round 2, 790 participants (56% response rate) from 63 countries completed the survey including 383 (48%) patients/caregivers and 407 (52%) health professionals. The overall top five outcomes were: kidney function, need for dialysis/transplant, life participation, cardiovascular disease and death. In the final round, patients/caregivers indicated higher scores for most outcomes (17/22 outcomes), and health professionals gave higher priority to mortality, hospitalization and cardiovascular disease (mean difference >0.3). Consensus was based upon the two groups yielding median scores of ≥7 and mean scores >7, and the proportions of both groups rating the outcome as ‘critically important’ being >50%. Four themes reflected the reasons for their priorities: imminent threat of a health catastrophe, signifying diminishing capacities, ability to self-manage and cope, and tangible and direct consequences. Conclusion. Across trials in CKD, the outcomes of highest priority to patients, caregivers and health professionals were kidney function, need for dialysis/transplant, life participation, cardiovascular disease and death.
AB - Background. Many outcomes of high priority to patients and clinicians are infrequently and inconsistently reported across trials in chronic kidney disease (CKD), which generates research waste and limits evidence-informed decision making. We aimed to generate consensus among patients/caregivers and health professionals on critically important outcomes for trials in CKD prior to kidney failure and the need for kidney replacement therapy, and to describe the reasons for their choices. Methods. This was an online two-round international Delphi survey. Adult patients with CKD (all stages and diagnoses), caregivers and health professionals who could read English, Spanish or French were eligible. Participants rated the importance of outcomes using a Likert scale (7–9 indicating critical importance) and a Best–Worst Scale. The scores for the two groups were assessed to determine absolute and relative importance. Comments were analysed thematically. Results. In total, 1399 participants from 73 countries completed Round 1 of the Delphi survey, including 628 (45%) patients/caregivers and 771 (55%) health professionals. In Round 2, 790 participants (56% response rate) from 63 countries completed the survey including 383 (48%) patients/caregivers and 407 (52%) health professionals. The overall top five outcomes were: kidney function, need for dialysis/transplant, life participation, cardiovascular disease and death. In the final round, patients/caregivers indicated higher scores for most outcomes (17/22 outcomes), and health professionals gave higher priority to mortality, hospitalization and cardiovascular disease (mean difference >0.3). Consensus was based upon the two groups yielding median scores of ≥7 and mean scores >7, and the proportions of both groups rating the outcome as ‘critically important’ being >50%. Four themes reflected the reasons for their priorities: imminent threat of a health catastrophe, signifying diminishing capacities, ability to self-manage and cope, and tangible and direct consequences. Conclusion. Across trials in CKD, the outcomes of highest priority to patients, caregivers and health professionals were kidney function, need for dialysis/transplant, life participation, cardiovascular disease and death.
KW - CKD
KW - Delphi survey
KW - outcomes
UR - http://www.scopus.com/inward/record.url?scp=85200118221&partnerID=8YFLogxK
U2 - 10.1093/ndt/gfae010
DO - 10.1093/ndt/gfae010
M3 - Article
C2 - 38236705
AN - SCOPUS:85200118221
SN - 0931-0509
VL - 39
SP - 1310
EP - 1321
JO - Nephrology Dialysis Transplantation
JF - Nephrology Dialysis Transplantation
IS - 8
ER -
