一个更新的系统性审查和共识定义为经手术期间医学标准化终点:患者舒适和缓解疼痛
Paul S Myles1, Sophie Wallace1, Oliver Boney2
1Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, VIC, Australia.
British journal of anaesthesia
|March 25, 2025
概括
这项研究更新了在手术期间和之后测量患者舒适度的标准化终点. 这些经过验证的措施,包括疼痛和恢复,对于评估新的舒适性增强治疗方法的临床试验至关重要.
科学领域:
- 麻醉学和外科手术期间的医学.
- 患者报告的结果
- 临床试验方法论 临床试验方法论
背景情况:
- 改善手术期间和手术后的患者舒适度是一个关键的临床问题.
- 评估改善舒适度的治疗方法之前的终点需要更新.
- 患者和公众的参与对于确定相关结果至关重要.
研究的目的:
- 更新和标准化临床试验中患者舒适度的结果指标.
- 确定验证,可靠,可行和以患者为中心的终点.
- 将患者和公众的观点纳入终点选择中.
主要方法:
- 对外科手术前研究进行系统审查,以确定舒适度领域和结果措施.
- 焦点小组,研讨会,以及与临床医生和患者团体的多轮德尔菲共识过程.
- 通过利克特等级得分 (中位数≥7,≥70%≥7) 和定性分析定义的共识.
主要成果:
- 在Delphi轮中,实现了100%的响应率.
- 确定了八个标准化终点:止痛药的使用,有效性,疼痛强度,术后恶心和吐 (PONV),离院后恶心和吐 (PDNV),严重的PONV,恢复质量 (QoR-15),以及动员时间.
- 所有确定的终点被评为有效,可靠,可行和以患者为中心.
结论:
- 该研究建议在临床试验中包括标准化的终点,以确保手术后患者的舒适性和疼痛.
- 这些更新的终点将提高这一领域的研究的一致性和相关性.
- 清晰的沟通和共享决策被强调为提高患者舒适度的关键.
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