Core Outcome Set for Reporting Results of Cholesteatoma Surgery From International Otology Outcome Group Consensus Study.

HYPOTHESIS: International consensus exists on optimal measures for reporting outcome from cholesteatoma surgery. This consensus can be used to create a core outcome set (COS) for publication standards.

BACKGROUND

Systematic reviews show that the quality of published evidence available to inform surgical decision-making in the management of cholesteatoma is limited with inadequate distinction between residual and recurrent cholesteatoma, use of survival analysis or audiometric reporting standards.

METHODS

The International Otology Outcome Group (IOOG) followed COS-STAD and COS-STAR guidelines to develop a COS document. A systematic literature review, which included stakeholder consultation, guided outcome selection. Using a Delphi process, IOOG members and the boards of 5 large otological societies refined the document using on-line survey and email. Consensus was defined as ≥85% agreement among participants across 2 survey rounds. Final outcome measures were categorized as principle (mandatory) or suggested (recommended) standards.

RESULTS

Principle reporting standards included: distinction of residual from recurrent cholesteatoma, with use of survival analysis for outcome at 5 years, description of technique for detection of residua, use of audiometric reporting standards, and distinction between complications from cholesteatoma and surgery. Suggested standards covered reporting of cholesteatoma severity, surgical nomenclature, and further audiometric measures. Patient-reported outcome measures are recognized as important, but too few responses were received to define an optimal PROM.

CONCLUSION

This COS provides a consensus-based framework for standardized reporting in cholesteatoma surgery. Adoption of the COS as a publishing standard should improve the quality of evidence available to guide surgical care.