瑞士巴塞尔大学医院Salome Dell-Kuster团队对术中不良事件分类进行了前瞻性验证。2020年8月25日，该研究发表在《英国医学杂志》上。

ClassIntra 1.0版是一种新开发的评估术中不良事件的分类系统，为了前瞻性地评估ClassIntra 1.0版的结构和标准有效性，研究组进行了一项国际、多中心队列研究，在欧洲、大洋洲和北美12个国家/地区的18个二级和三级中心招募了2520名在医院接受任何手术的患者。

研究组对2372例患者（94％）进行了30天评估死亡率的随访，并向参与中心的163名外科医生和麻醉医师进行调查。采用ClassIntra来评估术中并发症，采用Clavien-Dindo分类对术后并发症进行每日评估，直到出院。

在2520名患者中，有610名（24％）经历了至少一项术中不良事件，而有838名（33％）经历了至少一项术后并发症。多变量分析显示，随着ClassIntra等级的提高，发生更严重术后并发症的风险逐渐增加：与ClassIntra 0级相比，I级的优势比为0.99，II级为1.39，III级为2.62,IV级为3.81。在调查中，ClassIntra具有较高的标准有效性，组内相关系数为0.76，应答率为83％。

综上，ClassIntra是第一个以标准化方式来评估术中不良事件的前瞻性验证分类系统，通过公认的Clavien-Dindo分类将其与术后并发症相关联，有望用于对患者进行适当的术后护理分层，提高手术干预质量，并改善手术患者的长期结局。

附：英文原文

Title: Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study

Author: Salome Dell-Kuster, Nuno V Gomes, Larsa Gawria, Soheila Aghlmandi, Maame Aduse-Poku, Ian Bissett, Catherine Blanc, Christian Brandt, Richard B ten Broek, Heinz R Bruppacher, Cillian Clancy, Paolo Delrio, Eloy Espin, Konstantinos Galanos-Demiris, I Ethem Gecim, Shahbaz Ghaffari, Olivier Gié, Barbara Goebel, Dieter Hahnloser, Friedrich Herbst, Ioannidis Orestis, Sonja Joller, Soojin Kang, Rocio Martín, Johannes Mayr, Sonja Meier, Jothi Murugesan, Deirdre Nally, Menekse Ozcelik, Ugo Pace, Michael Passeri, Simone Rabanser, Barbara Ranter, Daniela Rega, Paul F Ridgway, Camiel Rosman, Roger Schmid, Philippe Schumacher, Alejandro Solis-Pena, Laura Villarino, Dionisios Vrochides, Alexander Engel, Greg O’Grady, Benjamin Loveday, Luzius A Steiner, Harry Van Goor, Heiner C Bucher, Pierre-Alain Clavien, Philipp Kirchhoff, Rachel Rosenthal

Issue&Volume: 2020/08/25

Abstract: Objective To prospectively assess the construct and criterion validity of ClassIntra version 1.0, a newly developed classification for assessing intraoperative adverse events.

Design International, multicentre cohort study.

Setting 18 secondary and tertiary centres from 12 countries in Europe, Oceania, and North America.

Participants The cohort study included a representative sample of 2520 patients in hospital having any type of surgery, followed up until discharge. A follow-up to assess mortality at 30 days was performed in 2372 patients (94%). A survey was sent to a representative sample of 163 surgeons and anaesthetists from participating centres.

Main outcome measures Intraoperative complications were assessed according to ClassIntra. Postoperative complications were assessed daily until discharge from hospital with the Clavien-Dindo classification. The primary endpoint was construct validity by investigating the risk adjusted association between the most severe intraoperative and postoperative complications, measured in a multivariable hierarchical proportional odds model. For criterion validity, inter-rater reliability was evaluated in a survey of 10 fictitious case scenarios describing intraoperative complications.

Results Of 2520 patients enrolled, 610 (24%) experienced at least one intraoperative adverse event and 838 (33%) at least one postoperative complication. Multivariable analysis showed a gradual increase in risk for a more severe postoperative complication with increasing grade of ClassIntra: ClassIntra grade I versus grade 0, odds ratio 0.99 (95% confidence interval 0.69 to 1.42); grade II versus grade 0, 1.39 (0.97 to 2.00); grade III versus grade 0, 2.62 (1.31 to 5.26); and grade IV versus grade 0, 3.81 (1.19 to 12.2). ClassIntra showed high criterion validity with an intraclass correlation coefficient of 0.76 (95% confidence interval 0.59 to 0.91) in the survey (response rate 83%).

Conclusions ClassIntra is the first prospectively validated classification for assessing intraoperative adverse events in a standardised way, linking them to postoperative complications with the well established Clavien-Dindo classification. ClassIntra can be incorporated into routine practice in perioperative surgical safety checklists, or used as a monitoring and outcome reporting tool for different surgical disciplines. Future studies should investigate whether the tool is useful to stratify patients to the appropriate postoperative care, to enhance the quality of surgical interventions, and to improve long term outcomes of surgical patients.

DOI: 10.1136/bmj.m2917

Source: https://www.bmj.com/content/370/bmj.m2917