학술논문
Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation
Document Type
article
Author
Sautenet, Bénédicte; Tong, Allison; Manera, Karine E; Chapman, Jeremy R; Warrens, Anthony N; Rosenbloom, David; Wong, Germaine; Gill, John; Budde, Klemens; Rostaing, Lionel; Marson, Lorna; Josephson, Michelle A; Reese, Peter P; Pruett, Timothy L; Hanson, Camilla S; O’Donoghue, Donal; Tam-Tham, Helen; Halimi, Jean-Michel; Shen, Jenny I; Kanellis, John; Scandling, John D; Howard, Kirsten; Howell, Martin; Cross, Nick; Evangelidis, Nicole; Masson, Philip; Oberbauer, Rainer; Fung, Samuel; Jesudason, Shilpa; Knight, Simon; Mandayam, Sreedhar; McDonald, Stephen P; Chadban, Steve; Rajan, Tasleem; Craig, Jonathan C
Source
Transplantation. 101(8)
Subject
Language
Abstract
BackgroundInconsistencies 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.MethodsIn 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.ResultsOne 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.ConclusionsGraft 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.