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Establishing a Core Outcome Measure for Graft Health

A Standardized Outcomes in Nephrology-Kidney Transplantation (SONG-Tx) Consensus Workshop Report

Tong, Allison, PhD1,2; Sautenet, Benedicte, MD, PhD3,4; Poggio, Emilio D., MD5; Lentine, Krista L., MD6; Oberbauer, Rainer, MD, PhD7; Mannon, Roslyn, MD8; Murphy, Barbara, MD9; Padilla, Benita, MD10; Chow, Kai Ming, MD11; Marson, Lorna, MD12; Chadban, Steve, MD, PhD13; Craig, Jonathan C., MBChB1,2; Ju, Angela, BSc1,2; Manera, Karine E., MIPH1,2; Hanson, Camilla S., BPsych (Hons)1,2; Josephson, Michelle A., MD14; Knoll, Greg, MD15 on behalf of the SONG-Tx Graft Health Workshop Investigators

doi: 10.1097/TP.0000000000002125
Original Clinical Science—General
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Background Graft loss, a critically important outcome for transplant recipients, is variably defined and measured, and incompletely reported in trials. We convened a consensus workshop on establishing a core outcome measure for graft loss for all trials in kidney transplantation.

Methods Twenty-five kidney transplant recipients/caregivers and 33 health professionals from 8 countries participated. Transcripts were analyzed thematically.

Results Five themes were identified. “Graft loss as a continuum” conceptualizes graft loss as a process, but requiring an endpoint defined as a discrete event. In “defining an event with precision and accuracy,” loss of graft function requiring chronic dialysis (minimum, 90 days) provided an objective and practical definition; retransplant would capture preemptive transplantation; relisting was readily measured but would overestimate graft loss; and allograft nephrectomy was redundant in being preceded by dialysis. However, the thresholds for renal replacement therapy varied. Conservative management was regarded as too ambiguous and complex to use routinely. “Distinguishing death-censored graft loss” would ensure clarity and meaningfulness in interpreting results. “Consistent reporting for decision making” by specifying time points and metrics (ie time to event) was suggested. “Ease of ascertainment and data collection” of the outcome from registries could support use of registry data to efficiently extend follow-up of trial participants.

Conclusions A practical and meaningful core outcome measure for graft loss may be defined as chronic dialysis or retransplant, and distinguished from loss due to death. Consistent reporting of graft loss using standardized metrics and time points may improve the contribution of trials to decision making in kidney transplantation.

This consensus workshop document proposes that graft loss should be defined as chronic dialysis or re-transplant and reported at specific time points, improving the contribution of trial data to decision-making in kidney transplantation.

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

4 INSERM, U1246, Tours, Franc Tours, France.

5 Department of Nephrology and Hypertension, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH.

6 Saint Louis University Center for Abdominal Transplantation, MO, United States.

7 Department of Internal Medicine, University of Vienna, Austria, Vienna.

8 School of Medicine, University of Alabama Birmingham, AL.

9 Department of Medicine, Mount Sinai Hospital, New York, NY.

10 Department of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.

11 Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.

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

13 Department of Renal Medicine, Royal Prince Alfred Hospital, Central Clinical School, The University of Sydney, Sydney, Australia.

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

15 Division of Nephrology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.

Received 22 October 2017. Revision received 17 January 2018.

Accepted 22 January 2018.

A complete list of the SONG-Tx Graft Loss Workshop investigators is provided in SupplementaryFile 1 http://links.lww.com/TP/B534.

This project is supported by a National Health and Medical Research Council Project Grant 1128564 and Program Grant 1092957. 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. B.S. participated in the research design, data collection, data analysis, and drafted the article. E.P. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. K.L.L. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. R.O. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. R.B.M. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. B.M. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. B.P. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. K.M.C. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. L.M. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. S.C. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. J.C.C. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. A.J. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. K.M. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. C.S.H. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. M.A.J. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. G.K. 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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