Establishing a Core Outcome Measure for Graft Health: a Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) Consensus Workshop Report

AbstractBackgroundGraft 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.MethodsTwenty-five kidney transplant recipients/caregivers and 33 health professionals from eight countries participated. Transcripts were analyzed thematically.ResultsFive 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; re-transplant 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.ConclusionsA 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. 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 eight 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; re-transplant 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 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. *A complete list of the SONG-Tx Graft Loss Workshop investigators is provided in Table S1 (SDC, http://ift.tt/2sPjFdU). Address for correspondence: Allison Tong, Centre for Kidney Research. The Children's Hospital at Westmead, Westmead, NSW 2145, Sydney, Australia, Phone: +61 2 9845 1467 Fax: +61 2 9845 1491 Email: allison.tong@sydney.edu.au Authors' specific contributions: AT participated in the research design, data collection, data analysis, and drafted the manuscript. BS participated in the research design, data collection, data analysis, and drafted the manuscript. EP participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. KLL participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. RO participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. RBM participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. BM participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. BP participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. KMC participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. LM participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. SC participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. JCC participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. AJ participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. KM participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. CSH participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. MAJ participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. GK participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. Disclosure: The authors declare no conflicts of interest. Funding: 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. 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 (http://ift.tt/2EZJQTY). Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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