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Toward Establishing Core Outcome Domains For Trials in Kidney Transplantation: Report of the Standardized Outcomes in Nephrology—Kidney Transplantation Consensus Workshops

Tong, Allison PhD1,2; Gill, John MD3; Budde, Klemens MD4; Marson, Lorna MD, FRCS5; Reese, Peter P. MD, MSCE6; Rosenbloom, David7; Rostaing, Lionel MD, PhD8; Wong, Germaine MBBS, PhD1,2,9; Josephson, Michelle A. MD10; Pruett, Timothy L. MD11; Warrens, Anthony N. MD12; Craig, Jonathan C. MBChB, PhD1,2; Sautenet, Benedicte MD, PhD1,2,13,14; Evangelidis, Nicole BSocSc1,2; Ralph, Angelique F. BPsych (Hons)1,2; Hanson, Camilla S. BPsych (Hons)1,2; Shen, Jenny I. MD15; Howard, Kirsten PhD1; Meyer, Klemens MD16; Perrone, Ronald D. MD16; Weiner, Daniel E. MD16; Fung, Samuel MBBS, FRCP17; Ma, Maggie K.M. MBBS, MPH18; Rose, Caren PhD3; Ryan, Jessica MBBS, PhD19; Chen, Ling-Xin MD10; Howell, Martin PhD1,2; Larkins, Nicholas MBBS, MMed (Clin Epi)2; Kim, Siah MBBS, PhD2; Thangaraju, Sobhana MD20; Ju, Angela BSc (Hons)1,2; Chapman, Jeremy R. FRACP9on behalf of the SONG-Tx Investigators

doi: 10.1097/TP.0000000000001774
Original Clinical Science—General

Background Treatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities.

Methods We convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals). In facilitated breakout groups, participants discussed the development and implementation of core outcome domains for trials in kidney transplantation.

Results Seven themes were identified. Reinforcing the paramount importance of graft outcomes encompassed the prevailing dread of dialysis, distilling the meaning of graft function, and acknowledging the terrifying and ambiguous terminology of rejection. Reflecting critical trade-offs between graft health and medical comorbidities was fundamental. Contextualizing mortality explained discrepancies in the prioritization of death among stakeholders—inevitability of death (patients), preventing premature death (clinicians), and ensuring safety (regulators). Imperative to capture patient-reported outcomes was driven by making explicit patient priorities, fulfilling regulatory requirements, and addressing life participation. Specificity to transplant; feasibility and pragmatism (long-term impacts and responsiveness to interventions); and recognizing gradients of severity within outcome domains were raised as considerations.

Conclusions Stakeholders support the inclusion of graft health, mortality, cardiovascular disease, infection, cancer, and patient-reported outcomes (ie, life participation) in a core outcomes set. Addressing ambiguous terminology and feasibility is needed in establishing these core outcome domains for trials in kidney transplantation.

Standardized Outcomes in Nephrology-Kidney Transplantation (SONG-Tx) convened 2 international consensus workshops in Boston and Hong Kong with patients/caregivers and health professionals to discuss the development and implementation of core outcome domains for trials in kidney transplantation. Supplemental digital content is available in the text.

1 Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.

2 Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, NSW, Australia.

3 Division of Nephrology, University of British Columbia, Vancouver, BC, Canada.

4 Department of Nephrology, Charité-Universitätsmedizin Berlin, Germany.

5 Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.

6 Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.

7 ESRD Network 18, Los Angeles, CA.

8 Clinique Universitaire de Nephrologie, CHU Michallon, Grenoble, France.

9 Centre for Transplant and Renal Research, Westmead Hospital, NSW, Westmead, Australia.

10 Department of Medicine, The University of Chicago, Chicago, IL.

11 Department of Surgery, University of Minnesota, Minneapolis, MN.

12 School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.

13 Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours Hospital, Tours, France.

14 INSERM, U1246, Tours, Franc Tours, France.

15 Department of Nephrology, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, CA.

16 William B. Schwartz Division of Nephrology, Tufts Medical Center, Boston, MA.

17 Jockey Club Nephrology & Urology Centre, Princess Margaret Hospital, Hong Kong.

18 The University of Hong Kong, Queen Mary Hospital, Hong Kong.

19 Department of Nephrology, Monash Medical Centre, Melbourne, Australia.

20 Depatment of Renal Medicine, Singapore General Hospital, Singapore.

Received 26 January 2017. Revision received 9 March 2017.

Accepted 13 March 2017.

A complete list of the SONG-Tx workshop investigators is provided in Supplementary File 1, SDC,http://links.lww.com/TP/B438.

This project is supported by a National Health and Medical Research Council Project Grant 1128564 and Program Grant 1092597. AT is supported by a NHMRC Career Development Fellowship 1106716.

The authors declare no conflicts of interest.

A.T. participated in the research design, data collection, data analysis, and drafted the article. J.G., K.B., L.M., P.P.R., D.R., L.R., G.W., M.A.J., T.L.P., A.W., J.C.C., B.S., N.E., A.F.R., C.S.H., J.I.S., K.H., K.M., R.P., S.F., M.M., C.R., J.R., L.X.C., M.H., N.L., S.K., S.T., A.J., and J.R.C. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing.

Correspondence: Allison Tong, PhD, Centre for Kidney Research. The Children’s Hospital at Westmead, Westmead, NSW 2145, Sydney, Australia. (allison.tong@sydney.edu.au).

Supplemental digital content (SDC) is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.transplantjournal.com).

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