Surgical Outcomes Research Centre, University College Hospital, London, UK; Health Services Research Centre, National Institute of Academic Anaesthesia, Royal College of Anaesthetists, London, 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. 2022 Jan;128(1):174-185. doi: 10.1016/j.bja.2021.09.027. Epub 2021 Nov 2.
Outcome selection underpins clinical trial interpretation. Inconsistency in outcome selection and reporting hinders comparison of different trials' results, reducing the utility of research findings.
We conducted an iterative consensus process to develop a set of Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC), following the established Core Outcome Measures for Effectiveness Trials (COMET) methodology. First, we undertook a systematic review of RCTs in high-impact journals to describe current outcome reporting trends. We then surveyed patients, carers, researchers, and perioperative clinicians about important outcomes after surgery. Finally, a purposive stakeholder sample participated in a modified Delphi process to develop a core outcome set for perioperative and anaesthesia trials.
Our systematic review revealed widespread inconsistency in outcome reporting, with variable or absent definitions, levels of detail, and temporal criteria. In the survey, almost all patients, carers, and clinicians rated clinical outcome measures critically important, but clinicians rated patient-centred outcomes less highly than patients and carers. The final core outcome set was: (i) mortality/survival (postoperative mortality, long-term survival); (ii) perioperative complications (major postoperative complications/adverse events; complications/adverse events causing permanent harm); (iii) resource use (length of hospital stay, unplanned readmission within 30 days); (iv) short-term recovery (discharge destination, level of dependence, or both); and (v) longer-term recovery (overall health-related quality of life).
This core set, incorporating important outcomes for both clinicians and patients, should guide outcome selection in future perioperative medicine or anaesthesia trials. Mapping these alongside standardised endpoint definitions will yield a comprehensive perioperative outcome framework.
结局选择是临床试验解释的基础。结局选择和报告的不一致阻碍了不同试验结果的比较，降低了研究结果的实用性。
我们采用已确立的 COMET 方法，通过迭代共识过程制定了一套围手术期和麻醉护理核心结局测量（COMPAC）。首先，我们对高影响力期刊中的 RCT 进行了系统评价，以描述当前的结局报告趋势。然后，我们调查了患者、护理人员、研究人员和围手术期临床医生术后的重要结局。最后，一个有针对性的利益相关者样本参与了一项改良 Delphi 过程，为围手术期和麻醉试验制定了核心结局集。
我们的系统评价显示，结局报告存在广泛的不一致，存在可变或缺失的定义、详细程度和时间标准。在调查中，几乎所有的患者、护理人员和临床医生都认为临床结局测量至关重要，但临床医生对以患者为中心的结局的重视程度低于患者和护理人员。最终的核心结局集包括：（i）死亡率/生存率（术后死亡率、长期生存率）；（ii）围手术期并发症（主要术后并发症/不良事件；导致永久性伤害的并发症/不良事件）；（iii）资源利用（住院时间、30 天内计划外再入院）；（iv）短期恢复（出院目的地、依赖程度或两者兼有）；和（v）长期恢复（总体健康相关生活质量）。
该核心集纳入了临床医生和患者都重视的重要结局，应指导未来围手术期医学或麻醉试验的结局选择。将这些结局与标准化的终点定义相结合，将产生一个全面的围手术期结局框架。
