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Definition and Classification of Intraoperative Complications (CLASSIC): Delphi Study and Pilot Evaluation

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Abstract

Background

Standardized reporting of intraoperative adverse events is important to enhance transparency. To the best of our knowledge, there is no validated definition and classification of intraoperative complications.

Methods

We conducted a two-round Delphi study to develop a definition and classification of intraoperative complications. Experts were contacted by email and sent a link to the online questionnaire. In a pilot study, two independent raters applied the definition and classification in a sample of 60 surgical interventions of low, intermediate, and high complexity and evaluated practicability. Interrater agreement of the classification was determined (raw categorical agreement, weighted kappa, and intraclass correlation).

Results

In the Delphi study, 40 of 52 experts (77 % return rate) from 14 countries took part in each round. The Delphi study resulted in a comprehensive definition of intraoperative complications as any deviation from the ideal intraoperative course occurring between skin incision and skin closure. The classification foresees four grades depending on the need for treatment (no need, grade I; need for treatment, grade II) and the severity of the complication (life-threatening/permanent disability, grade III; death, grade IV). The pilot study showed good practicability (6 on a 7-point scale) and a high raw agreement of 87 %, a weighted kappa of 0.83 [95 % confidence interval (CI) 0.73–0.94] and an intraclass correlation coefficient of 0.83 (95 % CI 0.73–0.90).

Conclusions

While the Delphi process enabled to develop definitions and classification of intraoperative complications by severity, further research including a multicentre international full-scale validation needs to be conducted with the ultimate goal to contribute to standardized reporting in surgical practice and research.

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Acknowledgments

We are very grateful to all experts who participated in this study. Their input was very important in the development of the proposed definition and classification.

Conflict of interest

No financial support was received for this study. Heiner C. Bucher is supported by Grants from Santésuisse and the Gottfried and Julia-Rhyner-Foundation. There are no conflicts of interest to declare. Rachel Rosenthal is an employee of F. Hoffmann-La Roche Ltd. since May 01, 2014. The present study was conducted before Rachel Rosenthal joined F. Hoffmann-La Roche Ltd. and has no connection to her employment by the company.

Author information

Authors and Affiliations

  1. Department of Surgery, University Hospital Basel, 4031, Basel, Switzerland

    Rachel Rosenthal, Henry Hoffmann & Salome Dell-Kuster

  2. Department of Surgery, University Hospital Zurich and University of Zurich, Zurich, Switzerland

    Pierre-Alain Clavien

  3. Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland

    Heiner C. Bucher & Salome Dell-Kuster

  4. Department of Anesthesiology, University Hospital Basel, Basel, Switzerland

    Salome Dell-Kuster

Authors
  1. Rachel Rosenthal
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  2. Henry Hoffmann
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  3. Pierre-Alain Clavien
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  4. Heiner C. Bucher
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  5. Salome Dell-Kuster
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Corresponding author

Correspondence to Rachel Rosenthal.

Electronic supplementary material

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Baseline characteristics and outcomes of the pilot study (PDF 196 kb)

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Rosenthal, R., Hoffmann, H., Clavien, PA. et al. Definition and Classification of Intraoperative Complications (CLASSIC): Delphi Study and Pilot Evaluation. World J Surg 39, 1663–1671 (2015). https://doi.org/10.1007/s00268-015-3003-y

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  • DOI: https://doi.org/10.1007/s00268-015-3003-y

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