Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation: A Multinational Delphi Survey With Patients, Caregivers, and Health Professionals

Bénédicte Sautenet, Allison Tong, Karine E Manera, Jeremy R Chapman, Anthony N Warrens, David Rosenbloom, Germaine Wong, John Gill, Klemens Budde, Lionel Rostaing, Lorna Marson, Michelle A Josephson, Peter P Reese, Timothy L Pruett, Camilla S Hanson, Donal O'Donoghue, Helen Tam-Tham, Jean-Michel Halimi, Jenny I Shen, John KanellisJohn D Scandling, Kirsten Howard, Martin Howell, Nick Cross, Nicole Evangelidis, Philip Masson, Rainer Oberbauer, Samuel Fung, Shilpa Jesudason, Simon Knight, Sreedhar Mandayam, Stephen P McDonald, Steve Chadban, Tasleem Rajan, Jonathan C Craig

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)1875-1886
Number of pages12
JournalTransplantation
Volume101
Issue number8
Early online date18 Apr 2017
DOIs
Publication statusPublished - 1 Aug 2017

Keywords

  • Journal Article

Fingerprint Dive into the research topics of 'Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation: A Multinational Delphi Survey With Patients, Caregivers, and Health Professionals'. Together they form a unique fingerprint.

Cite this