International consensus-based core outcome set for airway management clinical trials and observational studies: the Airway Terminology and Outcome Measures (ATOM) protocol.

Abstract

Introduction: Airway management describes a range of commonly performed procedures undertaken to enable invasive respiratory support for patients. Studies of airway management interventions report heterogeneous outcomes, impeding evidence synthesis and translation of findings into clinical practice. A core outcome set is a consensus-based standardised minimum collection of outcomes to be reported in a given area of healthcare. The Airway Terminology and Outcome Measures project aims to define a core outcome set and select outcome measurement instruments for future airway management research.

Methods and analysis: Following a systematic literature search, we generated a list of candidate outcomes by extracting outcomes and their measurement instruments from a random sample of included studies until saturation was reached and no new outcomes emerged. The search resulted in a long list of 64 outcomes for inclusion in the consensus building stage. Key stakeholders, including patients, clinicians and researchers, will be invited to participate in a multiround modified Delphi process and a panel meeting to finalise the core outcome set and agree to their measurement instruments.

Ethics and dissemination: The study was approved by the Health Research Authority and the London - Fulham Research Ethics Committee (24/LO/0544). All participants will provide informed consent. Study findings will be presented as conference proceedings and published in peer-reviewed medical journals.

Estimated start of this study: 20 November 2024 REGISTRATION NUMBER: COMET 3146.