Harmonization of adverse events monitoring following thoracic surgery: Pursuit of a common language and methodology.

OBJECTIVE

Thoracic surgery carries significant risk of postoperative adverse events (AEs). Multiple international recording systems are used to define and collect AEs following thoracic surgery procedures. We hypothesized that a simple-yet-ubiquitous approach to AE documentation could be developed to allow universal data entry into separate international databases.

METHODS

AE definitions of the Canadian Association of Thoracic Surgeons (CATS) system and 4 international databases were matched and compared. This consisted of reviewing the definition of each AE as described by their respective database and assessing compatibility with the CATS system. We developed a single set of 4 drop-down menus to enable clear classification and facilitated data entry, using 3 single-select mandatory lists and 1 multiselect optional list classifying type and severity of these events.

RESULTS

The CATS data elements were harmonized (ie, perfect or good) with 100% (European Society of Thoracic Surgeons), 89% (Society of Thoracic Surgeons), 74% (Esophagectomy Complications Consensus Group), and 73% (National Surgical Quality Improvement Program) of respective data elements. The addition of 17 AEs and 2 complication modifiers to the CATS system was implemented to achieve complete harmonization. Consequently, 100% of AE data elements currently included in all 4 international databases are perfectly or well-harmonized with the revised 4-choice drop down menu.

CONCLUSIONS

We describe a framework for a ubiquitously applicable approach to AE monitoring following thoracic surgery harmonized with AE definitions of all major thoracic international associations. Use of this AE collection framework allows for comprehensive evaluation of both the incidence and severity of all AEs after thoracic surgery along with quality indicators.