Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia.
Transplantation. 2018 Aug;102(8):1358-1366. doi: 10.1097/TP.0000000000002125.
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.
Twenty-five kidney transplant recipients/caregivers and 33 health professionals from 8 countries participated. Transcripts were analyzed thematically.
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.
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.
移植物丢失是移植受者的一个关键结局，在临床试验中其定义和测量方法各不相同，且报告不完整。我们就建立一个适用于所有肾移植试验的移植物丢失核心结局测量指标召开了共识研讨会。
来自 8 个国家的 25 名肾移植受者/照料者和 33 名卫生专业人员参加了会议。对转录本进行了主题分析。
确定了 5 个主题。“移植物丢失作为一个连续体”的概念将移植物丢失视为一个过程，但需要一个明确的终点定义为离散事件。在“精确和准确地定义事件”中，需要慢性透析（至少 90 天）的移植物功能丧失提供了一个客观实用的定义；再次移植将捕获抢先移植；重新列入名单很容易测量，但会高估移植物丢失；同种异体肾切除术在进行透析之前是多余的。然而，肾脏替代治疗的阈值各不相同。保守治疗被认为过于模糊和复杂，无法常规使用。“区分死亡删失的移植物丢失”将确保在解释结果时的清晰和有意义。“为决策制定进行一致报告”建议指定时间点和指标（即事件时间）。从登记处确定结局的简便性和数据收集可能支持使用登记处数据来有效地延长试验参与者的随访。
可以定义一种实用且有意义的移植物丢失核心结局测量指标，即慢性透析或再次移植，并将其与因死亡导致的丢失区分开来。使用标准化指标和时间点一致报告移植物丢失情况，可以提高试验对肾脏移植决策的贡献。
