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

作者：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 Espín, Konstantinos Galanos-Demiris, Ibrahim Ethem Gecim, Shahbaz Ghaffari, Olivier Gié, Barbara Goebel, Dieter Hahnloser, Friedrich Herbst, Orestis Ioannidis, Sonja Joller, Soo‐Jin Kang, Rocío Medina Martín, Johannes Mayr, Sonja Meier, Jothi Rajasekaran Murugesan, Deirdre Nally, Menekşe Özçelik, Ugo Pace, Michael Passeri, Simone Rabanser, Barbara Ranter, Daniela Rega, Paul F. Ridgway, Camiel Rosman, Roger Schmid, Philippe Schumacher, Alejandro Solís‐Peña, 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 · 发表于：BMJ · 年份：2020 · DOI：10.1136/bmj.m2917 · 被引用次数：163 · 研究领域：Cardiac, Anesthesia and Surgical Outcomes、Hemodynamic Monitoring and Therapy、Patient Safety and Medication Errors

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 complica...