Jackson Alexander I R, Boney Oliver, Pearse Rupert M, Kurz Andrea, Cooper D James, van Klei Wilton A, Cabrini Luca, Miller Timothy E, Moonesinghe S Ramani, Myles Paul S, Grocott Michael P W
Perioperative and Critical Care Theme, 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.
Surgical Outcomes Research Centre, University College Hospital, London, UK; Health Services Research Centre, National Institute of Academic Anaesthesia, Royal College of Anaesthetists, London, UK.
Br J Anaesth. 2023 Apr;130(4):404-411. doi: 10.1016/j.bja.2022.12.012. Epub 2023 Jan 23.
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.
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.
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 Clavien-Dindo classification of complications achieved threshold criteria for consensus in round 2 of the Delphi process but did not achieve the threshold criteria in round 3 where it scored equivalently to the Post Operative Morbidity Survey. Clavien-Dindo therefore received conditional endorsement as the most widely used measure. No composite measures of organ failure achieved an acceptable level of consensus.
Both 30-day and 1-yr mortality measures are recommended. No measure is recommended for organ failure. One measure (Clavien-Dindo) 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 deli-vered care. Further refinement of current measures, or development of novel measures, of postoperative morbidity might improve consensus in this area.
死亡率、发病率和器官衰竭是手术后重要且常见的严重危害。然而，有许多候选指标可用于描述这些结局领域。这些指标的定义差异很大，其有效性往往也不明确。作为围手术期医学国际标准化终点（StEP）倡议的一部分，本研究旨在得出一套用于围手术期临床试验的标准化且有效的死亡率、发病率和器官衰竭指标。
通过系统的文献综述以及采用StEP倡议中始终一致应用的方法进行的三阶段德尔菲共识过程，对三个终点领域（死亡率、发病率和器官衰竭）进行了探索。在共识过程的第三轮中评估了可靠性、可行性和以患者为中心的程度。
对于两个死亡率时间点，即30天死亡率和1年死亡率，达成了高度共识，并推荐使用这两个指标。没有器官衰竭终点指标达到共识推荐的阈值标准。并发症的Clavien-Dindo分类在德尔菲过程的第二轮中达到了共识阈值标准，但在第三轮中未达到阈值标准，其得分与术后发病率调查相当。因此，Clavien-Dindo作为使用最广泛的指标获得了有条件的认可。没有器官衰竭的综合指标达到可接受的共识水平。
推荐使用30天和1年死亡率指标。不推荐使用任何器官衰竭指标。一项指标（Clavien-Dindo）获得了术后发病率的有条件认可，但我们的研究结果表明，没有单一终点能够提供可靠且有效的指标来描述围手术期发病率，且该指标不依赖于所提供护理的质量。对当前术后发病率指标的进一步完善或开发新的指标，可能会提高该领域的共识。
