Meghan J Elliott, Kirsten M Fiest, Shannan Love, Dale Birdsell, Maureena Loth, Heather Dumka, Benny Rana, Nusrat Shommu, Eleanor Benterud, Sarah Gil, Dilaram Acharya, Tyrone G Harrison, Neesh Pannu, Matthew T James
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导言:需要进行高质量的临床试验,以确定预防急性肾损伤(AKI)的新型疗法的有效性和安全性。在本次共识研讨会上,我们确定了西司他丁预防肾毒性 AKI 临床试验中患者和护理人员在招募、干预实施和结果方面的优先事项:我们招募了有 AKI、慢性肾脏病或 AKI 危险因素(如重症监护住院)生活经历的成年人及其护理人员。我们采用改良的名义小组技术方法,进行了一系列面谈/虚拟混合讨论,涉及 3 个临床试验主题领域:(1) 同意和招募;(2) 干预实施;(3) 试验结果。参与者对每个主题领域的首选进行投票,并使用传统内容分析法对讨论记录进行归纳分析:13 人(11 名患者,2 名护理人员)参加了研讨会。在同意和招募方面,与会者优先考虑了支持技术的预筛选和家庭成员参与同意过程。在干预措施的实施方面,参与者优先考虑便于实施干预措施和回访的措施。在试验结果方面,参与者将与肾脏相关的结果和其他临床结果(如 AKI、慢性肾脏病、心血管事件)列为首要考虑因素。通过对记录誊本的分析,我们深入了解了护理团队和家属参与试验相关决策的情况、分配到安慰剂组的影响以及参与者的 AKI 和危重病经历的影响:我们研讨会的研究结果将为制定西司他丁预防肾毒性 AKI 的临床试验方案提供直接参考,并能帮助其他人在 AKI 试验设计中采用以患者为中心的方法。