Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study [术中不良事件分类的前瞻性验证（ClassIntra）：国际多中心队列研究]

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BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m2917 (Published 25 August 2020)
Cite this as: BMJ 2020;370:m2917

Authors
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

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.

Trial registration ClinicalTrials.gov NCT03009929.