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

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

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29 Citations (Scopus)

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
DOIs
Publication statusPublished - 2017

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    Sautenet, B., Tong, A., Manera, K., Chapman, J., Warrens, A., Rosenbloom, D., Wong, G., Gill, J., Budde, K., Rostaing, L., Marson, L., Josephson, M., Reese, P., Pruett, T., Hanson, C., O’Donoghue, D., Tam-Tham, H., Halimi, J-M., Shen, J., ... Craig, J. (2017). Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation: A Multinational Delphi Survey With Patients, Caregivers, and Health Professionals. Transplantation, 101(8), 1875-1886. https://doi.org/10.1097/TP.0000000000001776