系统评价和围手术期医学倡议的标准化结局的共识定义：以患者为中心的结局。
Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: patient-centred outcomes.
机构信息
UCL/UCLH Surgical Outcomes Research Centre, Centre for Perioperative Medicine, Department for Targeted Intervention, University College London, London, UK; Health Services Research Centre, National Institute for Academic Anaesthesia, Royal College of Anaesthetists, London, UK; National Institute for Health Research, Biomedical Research Centre, University College London Hospitals, London, UK.
Anaesthesia and Critical Care Research Area, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Integrative Physiology and Critical Illness Group, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
出版信息
Br J Anaesth. 2019 Nov;123(5):664-670. doi: 10.1016/j.bja.2019.07.020. Epub 2019 Sep 5.
BACKGROUND
Patient-centred outcomes are increasingly used in perioperative clinical trials. The Standardised Endpoints in Perioperative Medicine (StEP) initiative aims to define which measures should be used in future research to facilitate comparison between studies and to enable robust evidence synthesis.
METHODS
A systematic review was conducted to create a longlist of patient satisfaction, health-related quality of life, functional status, patient well-being, and life-impact measures for consideration. A three-stage Delphi consensus process involving 89 international experts was then conducted in order to refine this list into a set of recommendations.
RESULTS
The literature review yielded six patient-satisfaction measures, seven generic health-related quality-of-life measures, eight patient well-being measures, five functional-status measures, and five life-impact measures for consideration. The Delphi response rates were 92%, 87%, and 100% for Rounds 1, 2, and 3, respectively. Three additional measures were added during the Delphi process as a result of contributions from the StEP group members. Firm recommendations have been made about one health-related quality-of-life measure (EuroQol 5 Dimension, five-level version with visual analogue scale), one functional-status measure (WHO Disability Assessment Schedule version 2.0, 12-question version), and one life-impact measure (days alive and out of hospital at 30 days after surgery). Recommendations with caveats have been made about the Bauer patient-satisfaction measure and two life-impact measures (days alive and out of hospital at 1 yr after surgery, and discharge destination).
CONCLUSIONS
Several patient-centred outcome measures have been recommended for use in future perioperative studies. We suggest that every clinical study should consider using at least one patient-centred outcome within a suite of endpoints.
背景
以患者为中心的结局指标越来越多地应用于围手术期临床试验。标准化围手术期医学结局指标（StEP）倡议旨在定义未来研究中应使用哪些指标，以促进研究之间的比较，并实现稳健的证据综合。
方法
进行了系统评价，创建了一个患者满意度、健康相关生活质量、功能状态、患者幸福感和生活影响措施的长名单，以供考虑。然后，进行了一个由 89 名国际专家参与的三阶段 Delphi 共识过程，以将该清单精炼为一系列建议。
结果
文献综述产生了六个患者满意度措施、七个通用健康相关生活质量措施、八个患者幸福感措施、五个功能状态措施和五个生活影响措施供考虑。 Delphi 第 1、2 和 3 轮的回复率分别为 92%、87%和 100%。在 Delphi 过程中，由于 StEP 小组成员的贡献，又增加了三个额外的措施。关于一个健康相关生活质量措施（EuroQol 5 维度，带有视觉模拟量表的五水平版本）、一个功能状态措施（世界卫生组织残疾评估表 2.0，12 题版本）和一个生活影响措施（术后 30 天存活和出院天数）提出了明确的建议。对 Bauer 患者满意度措施和两个生活影响措施（术后 1 年存活和出院天数以及出院去向）提出了有保留的建议。
结论
已经推荐了一些以患者为中心的结局指标用于未来的围手术期研究。我们建议，每一项临床研究都应考虑在一系列结局指标中至少使用一个以患者为中心的结局指标。
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