对围手术期医学（StEP）计划中的标准化终点的系统回顾和共识定义：死亡率、发病率和器官衰竭

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对围手术期医学（StEP）计划中的标准化终点的系统回顾和共识定义：死亡率、发病率和器官衰竭

贵州医科大学麻醉与心脏电生理课题组

翻译：胡廷菊 

编辑：柏雪

审校：曹莹

背景：死亡率、发病率和器官衰竭是术后重要和常见的危害。虽然有许多候选测量方法来描述这些结果，但这些方法的定义高度可变，有效性往往不清楚。作为国际围手术期医学标准化终点（StEP）倡议的一部分，本研究旨在获得一套标准化和有效的衡量死亡率、发病率和器官衰竭的衡量指标，用于围手术期临床试验。

方法：通过系统的文献综述和在StEP计划中一致应用的三阶段德尔菲共识程序，探讨了三个终点领域（死亡率、发病率和器官衰竭）。在共识程序的第3轮中评估了可靠性、可行性和以患者为中心的能力。 

结果：在30天死亡率和1年死亡率这两个死亡时间点上达成了高水平的共识，并且建议采取这两种措施。对于共识建议的阈值标准没有一个器官衰竭终点达到。并发症的分类在第2轮达到共识的阈值标准但在第3轮中没有达到阈值标准，其评分与术后发病率调查相当。因此，作为最广泛使用的方法，它得到了有条件的认可。没有一个关于器官衰竭的综合指标达到了可接受的共识水平。    

结论：建议采用30天和1年死亡率测量方法。对于器官功能衰竭，没有可行的方法推荐。有一种方法（claviendindo）有条件地认可用于术后发病率，但我们的研究结果表明，没有一个终点提供可靠和有效的方法来描述围手术期发病率，而不依赖于所提供的护理质量。进一步细化当前的方法，或发展新的方法，术后发病率可能提高这一领域的共识。

原始文献来源：Jackson AIR, Boney O, Pearse RM, Kurz A, Cooper DJ, van Klei WA, Cabrini L, Miller TE, Moonesinghe SR, Myles PS, Grocott MPW; StEP-COMPACGroup. Systematic reviews and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: mortality, morbidity, and organ failure. Br J Anaesth. 2023 Jan 23:S0007-0912(22)00737-1. doi: 10.1016/j.bja.2022.12.012. Epub ahead of print. PMID: 36697275.      

英文原文：

Systematic reviews and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: mortality, morbidity, and organ failure

Abstract

Background:Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome domains. Definitions of these measures are highly variable, and validity is often unclear. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid measures of mortality, morbidity, and organ failure for use in perioperative clinical trials.

Methods: Three domains of endpoints (mortality,morbidity, and organ failure) were explored through systematic literature review and a three-stage Delphi consensus process using methods consistently applied across the StEP initiative. Reliability, feasibility, and patient-centredness were assessed in round 3 of the consensus process.

Results: A high level of consensus was achieved for two mortality time points, 30-day and 1-yr mortality, and these two measures are recommended. No organ failure endpoints achieved threshold criteria for consensus recommendation. The ClavieneDindo classification of complications achieved threshold criteria for consensus in round 2 of the Delphi processbut did not achieve the threshold criteria in round 3 where it scored equivalently to the Post Operative Morbidity Survey. ClavieneDindo therefore received conditional endorsement as the most widely used measure. No composite measures of

organ failure achieved an acceptable level of consensus.

Conclusions:Both 30-day and 1-yr mortality measures are recommended. No measure is recommended for organ failure. One measure (ClavieneDindo) is conditionally endorsed for postoperative morbidity, but our findings suggest that no single endpoint offers a reliable and valid measure to describe perioperative morbidity that is not dependent on the quality of delivered care. Further refinement of current measures, or development of novel measures, of postoperative morbidity might improve consensus in this area.

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文中所涉及药物使用、疾病诊疗等内容仅供医学专业人士参考。

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编辑：MiLu.米鹭

校对：Michel.米萱