TY - JOUR
T1 - Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation: A Multinational Delphi Survey With Patients, Caregivers, and Health Professionals
AU - Sautenet, Benedicte
AU - Tong, Allison
AU - Manera, Karine
AU - Chapman, Jeremy
AU - Warrens, Anthony
AU - Rosenbloom, David
AU - Wong, Germaine
AU - Gill, John
AU - Budde, Klemens
AU - Rostaing, Lionel
AU - Marson, Lorna
AU - Josephson, Michelle
AU - Reese, Peter
AU - Pruett, Timothy
AU - Hanson, Camilla
AU - O’Donoghue, Donal
AU - Tam-Tham, Helen
AU - Halimi, Jean-Michel
AU - Shen, Jenny
AU - Kanellis, John
AU - Scandling, John
AU - Howard, Kirsten
AU - Howell, Martin
AU - Cross, Nick
AU - Evangelidis, Nicole
AU - Masson, Philip
AU - Oberbauer, Rainer
AU - Fung, Samuel
AU - Jesudason, Shilpa
AU - Knight, Simon
AU - Mandayam, Sreedhar
AU - McDonald, Stephen
AU - Chadban, Steve
AU - Rajan, Tasleem
AU - Craig, Jonathan
PY - 2017/8/1
Y1 - 2017/8/1
N2 - Background Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. Methods In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During rounds 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7 to 9 (critically important), and analyzed comments thematically. Results One thousand eighteen participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed round 1, and 779 (77%) completed round 3. The top 8 outcomes that met the consensus criteria in round 3 (mean, ≥7.5; median, ≥8; proportion, >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin), and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): Skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: Capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. Conclusions Graft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.
AB - Background Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. Methods In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During rounds 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7 to 9 (critically important), and analyzed comments thematically. Results One thousand eighteen participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed round 1, and 779 (77%) completed round 3. The top 8 outcomes that met the consensus criteria in round 3 (mean, ≥7.5; median, ≥8; proportion, >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin), and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): Skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: Capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. Conclusions Graft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.
UR - http://www.scopus.com/inward/record.url?scp=85017612303&partnerID=8YFLogxK
U2 - 10.1097/TP.0000000000001776
DO - 10.1097/TP.0000000000001776
M3 - Article
SN - 0041-1337
VL - 101
SP - 1875
EP - 1886
JO - Transplantation
JF - Transplantation
IS - 8
ER -
