Recommendations for Intraoperative Adverse Events Data Collection in Clinical Studies and Study Protocols. An ICARUS...

Area of Science:

• Surgery
• Patient Safety
• Anesthesiology

Background:

• Intraoperative adverse events (iAEs) impact patient outcomes but are underreported.
• Current surgical literature lacks standardized systems for iAE data collection and dissemination.
• This gap hinders the analysis of iAE implications for patient safety.

Purpose of the Study:

• To present core-set variables for standardized collection of intraoperative adverse event data.
• To provide tools for consistent reporting and analysis of iAEs.
• To establish a foundation for a global adverse event data collection system.

Main Methods:

• Developed core-set variables based on globally validated ICARUS criteria for iAEs.
• Created a summary table to guide data summarization.
• Included example manuscript sections and scenarios for practical application.

Main Results:

• Presents a novel, comprehensive system for iAE data collection.
• Provides validated core-set variables synthesized from ICARUS criteria.
• Offers practical tools including text, figures, and video demonstrations.

Conclusions:

• The developed tools equip healthcare professionals to properly collect iAE data.
• Standardized iAE data collection is essential for improving patient safety.
• Future directions include wider adoption and translation of the collection system.