Aim

We systematically reviewed published outcome measures across randomised controlled trials (RCTs) of donor management interventions.

Methods

The systematic review was conducted in accordance with recommendations by the Cochrane Handbook and Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. We searched MEDLINE, Embase, CENTRAL, Web of Science, and trial databases from 1980 to February 2021 for RCTs of donor management interventions.

Results

Twenty-two RCTs (n=3432 donors) were included in our analysis. Fourteen RCTs (63.6%) reported a primary outcome relating to a single organ only. Eight RCTs primarily focused on aspects of donor optimisation in critical care. Thyroid hormones and methylprednisolone were the most commonly evaluated interventions (five and four studies, respectively). Only two studies, focusing on single organs (e.g. kidney), evaluated outcomes relating to other organs. The majority of studies evaluated physiological or biomarker-related outcomes. No study evaluated recipient health-related quality of life. Only one study sought consent from potential organ recipients.

Conclusions

The majority of RCTs evaluating donor management interventions only assessed single-organ outcomes or effects on donor stability in critical care. There is a need for an evaluation of patient-centred recipient outcomes and standardisation and reporting of outcome measures for future donor management RCTs.

中文翻译：

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实体器官捐献者管理研究的结果测量：系统评价

目的

我们系统地审查了有关捐助者管理干预措施的随机对照试验 (RCT) 中已发表的结果指标。

方法

系统评价是根据 Cochrane 手册和系统评价和元分析的首选报告项目声明的建议进行的。我们检索了 1980 年至 2021 年 2 月的 MEDLINE、Embase、CENTRAL、Web of Science 和试验数据库，以获取捐助者管理干预措施的 RCT。

结果

我们的分析包括了 22 个RCT（n = 3432 名捐赠者）。14 项 RCT (63.6%) 报告了仅与单个器官相关的主要结果。八项随机对照试验主要关注重症监护中供体优化的方面。甲状腺激素和甲基强的松龙是最常评估的干预措施（分别为五项和四项研究）。只有两项研究侧重于单个器官（例如肾脏），评估了与其他器官相关的结果。大多数研究评估了生理或生物标志物相关的结果。没有研究评估受者健康相关的生活质量。只有一项研究征求了潜在器官接受者的同意。

结论

大多数评估捐赠者管理干预的 RCT 仅评估了单器官结果或对重症监护中捐赠者稳定性的影响。需要对以患者为中心的受者结果进行评估，并为未来的供者管理 RCT 标准化和报告结果措施。