Multicenter Study

. 2020 Aug 25:370:m2917.

doi: 10.1136/bmj.m2917.

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

Salome Dell-Kuster^{1

2

3}, Nuno V Gomes^{4

3}, Larsa Gawria^{2

5}, Soheila Aghlmandi², Maame Aduse-Poku⁶, Ian Bissett⁷, Catherine Blanc⁸, Christian Brandt⁹, Richard B Ten Broek⁵, Heinz R Bruppacher¹⁰, Cillian Clancy¹¹, Paolo Delrio¹², Eloy Espin¹³, Konstantinos Galanos-Demiris¹⁴, I Ethem Gecim¹⁵, Shahbaz Ghaffari¹⁶, Olivier Gié¹⁷, Barbara Goebel¹⁸, Dieter Hahnloser¹⁷, Friedrich Herbst¹⁶, Orestis Ioannidis¹⁴, Sonja Joller¹⁹, Soojin Kang⁶, Rocio Martín¹³, Johannes Mayr¹⁸, Sonja Meier⁶, Jothi Murugesan²⁰, Deirdre Nally¹¹, Menekse Ozcelik²¹, Ugo Pace¹², Michael Passeri²², Simone Rabanser²³, Barbara Ranter²⁴, Daniela Rega¹², Paul F Ridgway¹¹, Camiel Rosman⁵, Roger Schmid²⁵, Philippe Schumacher⁹, Alejandro Solis-Pena¹³, Laura Villarino²⁶, Dionisios Vrochides²², Alexander Engel²⁰, Greg O'Grady⁷, Benjamin Loveday⁷, Luzius A Steiner^{4

3}, Harry Van Goor⁵, Heiner C Bucher^{2

3}, Pierre-Alain Clavien²⁷, Philipp Kirchhoff²⁸, Rachel Rosenthal²⁹

Affiliations

¹ Department of Anaesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, CH-4031 Basel, Switzerland salome.dell-kuster@usb.ch.
² Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital and University of Basel, Basel, Switzerland.
³ Department of Clinical Research, University of Basel, Basel, Switzerland.
⁴ Department of Anaesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, CH-4031 Basel, Switzerland.
⁵ Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands.
⁶ Department of Anaesthesiology, Guy's and St Thomas' Hospital, London, UK.
⁷ Department of Surgery, University of Auckland, Auckland, New Zealand.
⁸ Department of Anaesthesiology, University Hospital Lausanne, University of Lausanne, Lausanne, Switzerland.
⁹ Department of Anaesthesiology, Bürgerspital Solothurn, Solothurn, Switzerland.
¹⁰ Department of Anaesthesiology, Schulthess Clinic, Zurich, Switzerland.
¹¹ Department of Surgery, Tallaght University Hospital, Dublin, Ireland.
¹² Colorectal Surgical Oncology, Abdominal Oncology Department, Istituto Nazionale per lo Studio e la Cura dei Tumori, "Fondazione Giovanni Pascale" IRCCS, Naples, Italy.
¹³ Colorectal Surgery Unit, Hospital Valle de Hebron, Autonomous University of Barcelona, Barcelona, Spain.
¹⁴ Fourth Surgical Department, G Papanikolaou Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
¹⁵ Department of Surgery, Ankara University Medical School, Ankara, Turkey.
¹⁶ Department of Surgery, Hospital of St John of God Vienna, Sigmund Freud University Vienna-Medical School, Vienna, Austria.
¹⁷ Department of Visceral Surgery, University Hospital Lausanne, University of Lausanne, Lausanne, Switzerland.
¹⁸ Department of Surgery, University Children's Hospital Basel, Basel, Switzerland.
¹⁹ Department of Anaesthesiology, University Children's Hospital Basel, Basel, Switzerland.
²⁰ University of Sydney, Royal North Shore Hospital, Sydney, Australia.
²¹ Department of Anaesthesiology, Ankara University Medical School, Ankara, Turkey.
²² Department of Surgery, Carolinas Medical Centre, Charlotte, NC, USA.
²³ Department of Anaesthesiology, Cantonal Hospital Graubünden, Chur, Switzerland.
²⁴ Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.
²⁵ Department of Surgery, Bürgerspital Solothurn, Solothurn, Switzerland.
²⁶ Department of Anaesthesiology and Reanimation, Hospital Valle de Hebron, Autonomous University of Barcelona, Barcelona, Spain.
²⁷ Department of Surgery and Transplantation, University Hospital Zurich, Zurich, Switzerland.
²⁸ Department of General Surgery, University Hospital Basel, Basel, Switzerland.
²⁹ Medical Faculty, University of Basel, Basel, Switzerland.

PMID: 32843333
PMCID: PMC7500355
DOI: 10.1136/bmj.m2917

Multicenter Study

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

Salome Dell-Kuster et al. BMJ. 2020.

. 2020 Aug 25:370:m2917.

doi: 10.1136/bmj.m2917.

Authors

Affiliations

¹ Department of Anaesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, CH-4031 Basel, Switzerland salome.dell-kuster@usb.ch.
² Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital and University of Basel, Basel, Switzerland.
³ Department of Clinical Research, University of Basel, Basel, Switzerland.
⁴ Department of Anaesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, CH-4031 Basel, Switzerland.
⁵ Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands.
⁶ Department of Anaesthesiology, Guy's and St Thomas' Hospital, London, UK.
⁷ Department of Surgery, University of Auckland, Auckland, New Zealand.
⁸ Department of Anaesthesiology, University Hospital Lausanne, University of Lausanne, Lausanne, Switzerland.
⁹ Department of Anaesthesiology, Bürgerspital Solothurn, Solothurn, Switzerland.
¹⁰ Department of Anaesthesiology, Schulthess Clinic, Zurich, Switzerland.
¹¹ Department of Surgery, Tallaght University Hospital, Dublin, Ireland.
¹² Colorectal Surgical Oncology, Abdominal Oncology Department, Istituto Nazionale per lo Studio e la Cura dei Tumori, "Fondazione Giovanni Pascale" IRCCS, Naples, Italy.
¹³ Colorectal Surgery Unit, Hospital Valle de Hebron, Autonomous University of Barcelona, Barcelona, Spain.
¹⁴ Fourth Surgical Department, G Papanikolaou Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
¹⁵ Department of Surgery, Ankara University Medical School, Ankara, Turkey.
¹⁶ Department of Surgery, Hospital of St John of God Vienna, Sigmund Freud University Vienna-Medical School, Vienna, Austria.
¹⁷ Department of Visceral Surgery, University Hospital Lausanne, University of Lausanne, Lausanne, Switzerland.
¹⁸ Department of Surgery, University Children's Hospital Basel, Basel, Switzerland.
¹⁹ Department of Anaesthesiology, University Children's Hospital Basel, Basel, Switzerland.
²⁰ University of Sydney, Royal North Shore Hospital, Sydney, Australia.
²¹ Department of Anaesthesiology, Ankara University Medical School, Ankara, Turkey.
²² Department of Surgery, Carolinas Medical Centre, Charlotte, NC, USA.
²³ Department of Anaesthesiology, Cantonal Hospital Graubünden, Chur, Switzerland.
²⁴ Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.
²⁵ Department of Surgery, Bürgerspital Solothurn, Solothurn, Switzerland.
²⁶ Department of Anaesthesiology and Reanimation, Hospital Valle de Hebron, Autonomous University of Barcelona, Barcelona, Spain.
²⁷ Department of Surgery and Transplantation, University Hospital Zurich, Zurich, Switzerland.
²⁸ Department of General Surgery, University Hospital Basel, Basel, Switzerland.
²⁹ Medical Faculty, University of Basel, Basel, Switzerland.

PMID: 32843333
PMCID: PMC7500355
DOI: 10.1136/bmj.m2917

Erratum in

Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study.
[No authors listed] [No authors listed] BMJ. 2025 Jan 22;388:r117. doi: 10.1136/bmj.r117. BMJ. 2025. PMID: 39843180 Free PMC article. No abstract available.

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.

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the Goldschmidt-Jacobson Foundation, University of Basel, Foundation for Research and Education in Anaesthesiology, Switzerland, and VSB fonds (Verenigde Spaar Bankenfonds) for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. RR is an employee of F Hoffmann-La Roche (includes Stock-Settled Appreciation Rights). The study has no connection to her employment by the company. RR continues to be affiliated to the University of Basel.

Figures

**Fig 1**
Flow diagram of patients in the validation study of ClassIntra

**Fig 2**
Multivariable hierarchical proportional odds model for the most severe postoperative complications according to the Clavien-Dindo classification (three categories for outcome: no postoperative complications, grades I-II, and grades III-V), adjusted for the most relevant confounders. ASA=American Society of Anesthesiologists’ physical status level

See this image and copyright information in PMC

Comment in

Intraoperative adverse events grading tools and their role in honest and accurate reporting of surgical outcomes.
Cacciamani GE. Cacciamani GE. Surgery. 2022 Sep;172(3):1035-1036. doi: 10.1016/j.surg.2022.04.029. Epub 2022 May 18. Surgery. 2022. PMID: 35597615 No abstract available.

References

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1. International Surgical Outcomes Study group . Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth 2016;117:601-9. 10.1093/bja/aew316 - DOI - PMC - PubMed
1. Weiser TG, Regenbogen SE, Thompson KD, et al. . An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet 2008;372:139-44. 10.1016/S0140-6736(08)60878-8 - DOI - PubMed
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Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study

Affiliations

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

Authors

Affiliations

Erratum in

Abstract

Conflict of interest statement

Figures

Comment in

References

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MeSH terms

Associated data

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Full Text Sources

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