TY - JOUR
T1 - Developing consensus-based priority outcome domains for trials in kidney transplantation
T2 - a multinational Delphi survey with patients, caregivers and health professionals
AU - Sautenet, Bénédicte
AU - Tong, Allison
AU - Manera, Karine E.
AU - Chapman, Jeremy R
AU - Warrens, Anthony N.
AU - Rosenbloom, David
AU - Wong, Germaine
AU - Gill, John
AU - Budde, Klemens
AU - Rostaing, Lionel
AU - Marson, Lorna
AU - Josephson, Michelle A.
AU - Reese, Peter P.
AU - Pruett, Timothy L.
AU - Hanson, Camilla S.
AU - O’Donoghue, Donal
AU - Tam-Tham, Helen
AU - Halimi, Jean Michel
AU - Shen, Jenny I.
AU - Kanellis, John
AU - Scandling, John D.
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 P
AU - Chadban, Steve
AU - Rajan, Tasleem
AU - Craig, Jonathan C
PY - 2017/8
Y1 - 2017/8
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 Round 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 7-9 (critically important), and analyzed comments thematically. RESULTS: 1018 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 and 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 Round 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 7-9 (critically important), and analyzed comments thematically. RESULTS: 1018 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 and 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
AN - SCOPUS:85017612303
SN - 0041-1337
VL - 101
SP - 1875
EP - 1886
JO - Transplantation
JF - Transplantation
IS - 8
ER -
