Tennankore Karthik K, Gunaratnam Lakshman, Suri Rita S, Yohanna Seychelle, Walsh Michael, Tangri Navdeep, Prasad Bhanu, Gogan Nessa, Rockwood Kenneth, Doucette Steve, Sills Laura, Kiberd Bryce, Keough-Ryan Tammy, West Kenneth, Vinson Amanda
Division of Nephrology, Department of Medicine, Dalhousie University & Nova Scotia Health Authority, Halifax, Canada.
Division of Nephrology, Department of Medicine, Western University, London, ON, Canada.
Can J Kidney Health Dis. 2020 Sep 10;7:2054358120957430. doi: 10.1177/2054358120957430. eCollection 2020.
Understanding how frailty affects patients listed for transplantation has been identified as a priority research need. Frailty may be associated with a high risk of death or wait-list withdrawal, but this has not been evaluated in a large multicenter cohort of Canadian wait-listed patients.
The primary objective is to evaluate whether frailty is associated with death or permanent withdrawal from the transplant wait list. Secondary objectives include assessing whether frailty is associated with hospitalization, quality of life, and the probability of being accepted to the wait list.
Prospective cohort study.
Seven sites with established renal transplant programs that evaluate patients for the kidney transplant wait list.
Individuals who are being considered for the kidney transplant wait list.
We will assess frailty using the Fried Phenotype, a frailty index, the Short Physical Performance Battery, and the Clinical Frailty Scale at the time of listing for transplantation. We will also assess frailty at the time of referral to the wait list and annually after listing in a subgroup of patients.
The primary outcome of the composite of time to death or permanent wait-list withdrawal will be compared between patients who are frail and those who are not frail and will account for the competing risks of deceased and live donor transplantation. Secondary outcomes will include number of hospitalizations and length of stay, and in a subset, changes in frailty severity over time, change in quality of life, and the probability of being listed. Recruitment of 1165 patients will provide >80% power to identify a relative hazard of ≥1.7 comparing patients who are frail to those who are not frail for the primary outcome (2-sided α = .05), whereas a more conservative recruitment target of 624 patients will provide >80% power to identify a relative hazard of ≥2.0.
Through December 2019, 665 assessments of frailty (inclusive of those for the primary outcome and all secondary outcomes including repeated measures) have been completed.
There may be variation across sites in the processes of referral and listing for transplantation that will require consideration in the analysis and results.
This study will provide a detailed understanding of the association between frailty and outcomes for wait-listed patients. Understanding this association is necessary before routinely measuring frailty as part of the wait-list eligibility assessment and prior to ascertaining the need for interventions that may modify frailty.
Not applicable as this is a protocol for a prospective observational study.
了解衰弱如何影响移植等待名单上的患者已被确定为一项优先研究需求。衰弱可能与高死亡风险或从等待名单上退出有关，但尚未在加拿大等待名单上的大型多中心队列患者中进行评估。
主要目的是评估衰弱是否与死亡或从移植等待名单上永久退出有关。次要目的包括评估衰弱是否与住院、生活质量以及被列入等待名单的可能性有关。
前瞻性队列研究。
七个设有成熟肾移植项目的地点，这些项目对患者进行肾移植等待名单评估。
正在考虑列入肾移植等待名单的个体。
我们将在移植登记时使用Fried表型、衰弱指数、简短体能表现电池测试和临床衰弱量表来评估衰弱情况。我们还将在转诊至等待名单时以及在一组患者登记后每年评估衰弱情况。
将比较衰弱患者和非衰弱患者在死亡或永久从等待名单上退出的复合时间这一主要结局，并考虑死者和活体供体移植的竞争风险。次要结局将包括住院次数和住院时间，在一个子集中，还包括衰弱严重程度随时间的变化、生活质量的变化以及被列入名单的可能性。招募1165名患者将提供超过80%的把握度，以确定在主要结局方面，衰弱患者与非衰弱患者相比相对风险≥1.7（双侧α = 0.05），而更为保守的招募目标624名患者将提供超过80%的把握度，以确定相对风险≥2.0。
截至2019年12月，已完成665次衰弱评估（包括主要结局和所有次要结局评估，包括重复测量）。
移植转诊和登记过程在各地点可能存在差异，这在分析和结果中需要考虑。
本研究将详细了解衰弱与等待名单上患者结局之间的关联。在将衰弱作为等待名单资格评估的一部分进行常规测量之前，以及在确定是否需要采取可能改善衰弱状况的干预措施之前，了解这种关联是必要的。
不适用，因为这是一项前瞻性观察性研究的方案。
