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

被引：74

作者：

Sautenet, Benedicte ^{[1
,2
,3
,4
,5
]}

Tong, Allison ^{[1
,2
]}

Manera, Karine E. ^{[1
,2
]}

Chapman, Jeremy R. ^{[6
]}

Warrens, Anthony N. ^{[7
]}

Rosenbloom, David ^{[8
]}

Wong, Germaine ^{[1
,2
,6
]}

Gill, John ^{[9
]}

Budde, Klemens ^{[10
]}

Rostaing, Lionel ^{[11
]}

Marson, Lorna ^{[12
]}

Josephson, Michelle A. ^{[13
]}

Reese, Peter P. ^{[14
]}

Pruett, Timothy L. ^{[15
]}

Hanson, Camilla S. ^{[1
,2
]}

O'Donoghue, Donal ^{[16
]}

Tam-Tham, Helen ^{[17
]}

Halimi, Jean-Michel ^{[3
,4
]}

Shen, Jenny I. ^{[18
]}

Kanellis, John ^{[19
]}

Scandling, John D. ^{[20
]}

Howard, Kirsten ^{[1
]}

Howell, Martin ^{[1
,2
]}

Cross, Nick ^{[21
]}

Evangelidis, Nicole ^{[1
,2
]}

Masson, Philip ^{[22
]}

Oberbauer, Rainer ^{[23
]}

Fung, Samuel ^{[24
]}

Jesudason, Shilpa ^{[25
,26
]}

Knight, Simon ^{[27
]}

Mandayam, Sreedhar ^{[28
]}

McDonald, Stephen P. ^{[25
,26
,29
]}

Chadban, Steve ^{[30
]}

Rajan, Tasleem ^{[17
]}

Craig, Jonathan C. ^{[1
,2
]}

机构：

[1] Univ Sydney, Sydney Sch Publ Hlth, Sydney, NSW, Australia

[2] Childrens Hosp, Ctr Kidney Res, Westmead, NSW, Australia

[3] Univ Tours, Fac Med, Tours, France

[4] Tours Hosp, Dept Nephrol & Clin Immunol, Tours, France

[5] INSERM, U1246, Tours, France

[6] Westmead Hosp, Ctr Transplant & Renal Res, Sydney, NSW, Australia

[7] Queen Mary Univ London, Sch Med & Dent, London, England

[8] ESRD Network 18, Los Angeles, CA USA

[9] Univ British Columbia, Div Nephrol, Vancouver, BC, Canada

[10] Charite, Dept Nephrol, Berlin, Germany

[11] Ctr Hosp Univ, Dept Nephrol Dialysis & Organ Transplantat, Toulouse, France

[12] Univ Edinburgh, Transplant Unit, Edinburgh, Midlothian, Scotland

[13] Univ Chicago, Dept Med, 5841 S Maryland Ave, Chicago, IL 60637 USA

[14] Univ Penn, Perelman Sch Med, Renal Div, Philadelphia, PA 19104 USA

[15] Univ Minnesota, Dept Surg, Box 242 UMHC, Minneapolis, MN 55455 USA

[16] Salford Royal NHS Fdn Trust, Dept Renal Med, Salford, Lancs, England

[17] Univ Calgary, Dept Community Hlth Sci, Calgary, AB, Canada

[18] Harbor UCLA Med Ctr, Los Angeles Biomed Res Inst, Dept Nephrol, Los Angeles, CA USA

[19] Monash Univ, Dept Nephrol, Dept Med, Monash Hlth & Ctr Inflammatory Dis, Clayton, Vic, Australia

[20] Stanford Univ, Dept Med, Sch Med, Stanford, CA 94305 USA

[21] Christchurch Hosp, Dept Nephrol, Christchurch, New Zealand

[22] Royal Infirm Edinburgh NHS Trust, Dept Renal Med, Edinburgh, Midlothian, Scotland

[23] Univ Vienna, Div Nephrol, Dept Internal Med, Vienna, Austria

[24] Princess Margaret Hosp, Jockey Club Nephrol & Urol Ctr, Hong Kong, Hong Kong, Peoples R China

[25] Royal Adelaide Hosp, Cent & Northern Adelaide Renal & Transplantat Ser, Adelaide, SA, Australia

[26] Univ Adelaide, Fac Hlth & Med Sci, Adelaide, SA, Australia

[27] Univ Oxford, Nuffield Dept Surg Sci, Ctr Evidence Transplantat, Oxford, England

[28] Baylor Coll Med, Nephrol Sect, Selzman Inst Kidney Hlth, Houston, TX 77030 USA

[29] South Australia Hlth & Med Res Inst, ANZDATA Registry, Adelaide, SA, Australia

[30] Royal Prince Alfred Hosp, Renal Med & Transplantat, Sydney, NSW, Australia

来源：

TRANSPLANTATION | 2017年 / 101卷 / 08期

基金：

澳大利亚国家健康与医学研究理事会; 英国医学研究理事会;

关键词：

QUALITY-OF-LIFE; CLINICAL-TRIALS; RECIPIENTS; SET; IMMUNOSUPPRESSION; CONSISTENCY; PREVENTION; DIAGNOSIS; EDUCATION; DISEASE;

D O I：

10.1097/TP.0000000000001776

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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.

引用

页码：1875 / 1886

页数：12

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