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

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 .

Simple radiologic assessment of visceral obesity and prediction of surgical morbidity in high-risk endometrial cancer: a reliability and accuracy pilot study

“…d Surgical complications were classified using two corresponding classification systems: the ClassIntra for intraoperative adverse events 26 , and the Dindo-Clavien 27 for postoperative complications.…”

“…LPAL: laparoscopic para-aortic lymphadenectomy a Adverse events were classified using two corresponding systems: ClassIntra for intraoperative 26 and Dindo-Clavien 27 for postoperative.…”

Simple radiologic assessment of visceral obesity and prediction of surgical morbidity in high-risk endometrial cancer: a reliability and accuracy pilot study

“…For the second phase, the primary end-point (surgical morbidity) was a core outcome set defined as the presence of any of the following criteria: 1) need for blood transfusion, 2) Haematocrit drop > 90th percentile (>11.8% in our cohort), 3) Total operative time >90th percentile (>350 min in our cohort), 4) laparoscopic para-aortic lymphadenectomy operative time >90th percentile (>135 min in our cohort), 5) Intraoperative surgical complications [?] grade III 26 or during para-aortic lymphadenectomy, 6) Postoperative surgical complications [?] grade III 27 or related to para-aortic lymphadenectomy, 7) uncompleted or converted laparoscopic para-aortic lymphadenectomy (Table S1).…”

Prospektive Kohortenstudie bei stationären augenchirurgischen Patienten für die Validierung der ClassIntra-Klassifikation für unerwünschte intraoperative Ereignisse

“…Durch steigenden politischen Druck auf die Leistungserbringer und Versicherer, eine Qualitätserfassung routinemäßig durchzuführen, ist eine generische Klassifikation, die disziplinübergreifend anwendbar ist, erstrebenswert. Ziel der vorliegenden Studie war es deshalb, die Validität und Praktikabilität von ClassIntra, einer kürzlich entwickelten und prospektiv validierten Klassifikation für unerwünschte intraoperative Ereignisse [12], auch in der Augenchirurgie zu erörtern. Die ClassIntra-Klassifikation hat bereits in vielen verschiedenen chirurgischen Disziplinen eine gute Validität und Praktikabilität gezeigt [12].…”

“…Ziel der vorliegenden Studie war es deshalb, die Validität und Praktikabilität von ClassIntra, einer kürzlich entwickelten und prospektiv validierten Klassifikation für unerwünschte intraoperative Ereignisse [12], auch in der Augenchirurgie zu erörtern. Die ClassIntra-Klassifikation hat bereits in vielen verschiedenen chirurgischen Disziplinen eine gute Validität und Praktikabilität gezeigt [12]. Sie ist in Kongruenz zu Clavien-Dindo für postoperative Komplikationen [8,13,14] ebenfalls in 5 Schweregrade unterteilt und erfasst außerdem sowohl anästhesiologische als auch chirurgische Abweichungen vom idealen intraoperativen Verlauf zwischen Hautschnitt und Hautnaht im gleichen Klassifikationssystem.…”