Establishing a Core Outcome Measure for Graft Health: A standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) Consensus Workshop Report
Bénédicte Sautenet1, Allison Tong 2,3, Emilio Poggio4, Krista L Lentine5, Rainer Oberbauer6, Roslyn Mannon7, Barbara Murphy8, Benita Padilla9, Kai Ming Chow10, Lorna Marson11, Steve Chadban12, Jonathan Craig2,3, Angela Ju2,3, Karine Manera2,3, Camilla Hanson2,3, Michelle Josephson13, Greg Knoll14.
1Department of Nephrology and Clinical Immunology, CHU Tours, Tours, France; 2Sydney School of Public Health, The University of Sydney, Sydney, Australia; 3Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, Australia; 4Department of Nephrology and Hypertension, Glickman Urological and Kidney Institute, Cleveland, OH, United States; 5Transplantation, 5Saint Louis University Center for Abdominal Transplantation, Saint Louis , MO, United States; 6Department of Internal Medicine, University of Vienna, Vienna, Austria; 7School of Medicine, University of Alabama Birmingham, Birmingham, AL, United States; 8Department of Medicine, Mount Sinai Hospital, New York, NY, United States; 9Department of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines; 10Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong; 11Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom; 12Department of Renal Medicine, Royal Prince Alfred Hospital, Sydney, Australia; 13Department of Medicine, The University of Chicago, Chicago, IL, United States; 14Division of Nephrology, The Ottawa Hospital and University of Ottawa, Ottawa, ON, Canada
SONG-Tx .
Background: Graft loss, a critically important outcome for transplant recipients, is variably defined andmeasured,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-fivekidney transplant recipients/caregivers and 33 health professionals from eight countries participated. Transcripts were analyzed thematically. Results:Five themeswere identified. “Graft loss as a continuum”conceptualizesgraft 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 andpractical definition;re-transplant would capture pre-emptive transplantation;relisting was readily measured but would overestimate graft loss;and allograft nephrectomywasredundant in being preceded by dialysis. However,the thresholds for renal replacement therapy varied. Conservative management was regarded as too ambiguous and complexto 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 (i.e.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 re-transplant,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.
