@article{14130,
author = {Salome Dell-Kuster and Nuno V Gomes and Larsa Gawria and Soheila Aghlmandi and Maame Aduse-Poku and Ian Bissett and Catherine Blanc and Christian Brandt and Richard B ten Broek and Heinz R. Bruppacher and Cillian Clancy and Paolo Delrio and Eloy Espin and Konstantinos Galanos-Demiris and I Ethem Gecim and Shahbaz Ghaffari and Olivier Gié and Barbara Goebel and Dieter Hahnloser and Friedrich Herbst and Ioannidis Orestis and Sonja Joller and Soojin Kang and Rocio Martín and Johannes Mayr and Sonja Meier and Jothi Murugesan and Deirdre Nally and Menekse Ozcelik and Ugo Pace and Michael Passeri and Simone Rabanser and Barbara Ranter and Daniela Rega and Paul F Ridgway and Camiel Rosman and Roger Schmid and Philippe Schumacher and Alejandro Solis-Pena and Laura Villarino and Dionisios Vrochides and Alexander Engel and Greg O’Grady and Benjamin Loveday and Luzius A Steiner and Harry Van Goor and Heiner C Bucher and Pierre-Alain Clavien and Philipp Kirchhoff and Rachel Rosenthal},
title = {Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study},
abstract = {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
.
},
year = {2020},
journal = {BMJ},
volume = {370},
chapter = {m2917},
pages = {m2917},
month = {08/2020},
issn = {1756-1833},
doi = {10.1136/bmj.m2917},
}