Airway Terminology and Outcome Measures (ATOM): A core outcome set development process

Introduction: Airway management is a commonly performed procedure in elective and emergency settings. Complications of airway management constitute a significant proportion of episodes of patient harm during anaesthesia and litigation against anaesthetists. Studies evaluating approaches and devices used for airway management use heterogeneous outcomes and definitions, which hampers interpretation and evidence synthesis. We aim to produce a multi-stakeholder core outcome set (COS) for airway management research.

Methods: We will perform a systematic review to identify candidate outcomes reported in ongoing and published randomised controlled trials and observational studies investigating airway management. This will be followed by an international modified Delphi study involving patients, clinicians, researchers, and other stakeholders. We will finalise the selection of the COS items, along with definitions for proposed measurement instruments and timings, at an international consensus meeting. We will follow the methodology recommended by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative.

Ethics and dissemination: NHS Research Ethical Committee approval will be obtained for the study. Consent will be obtained from stakeholders prior to the Delphi surveys and consensus meetings. The aim is to produce the first agreed COS for airway management research, with broad engagement from leading international professional societies ensuring widespread, long-term adoption.


Contributors

1. Kariem El-Boghdadly, Consultant (Chief Investigator); Guy's and St Thomas' NHS Foundation Trust, London, UK
2. Jan Hansel, NIHR Academic Clinical Fellow in Intensive Care Medicine; Manchester Foundation Trust, Manchester, UK
3. Tim Cook, Consultant; Bath Hospital, Bath, UK
4. Kate Rivett, Patient Representative; Difficult Airway Society, London, UK
5. Gillian Radcliffe, Research Manager; Guy's and St Thomas' NHS Foundation Trust, London, UK
6. Tino Greif, Consultant; University of Bern, Bern, Switzerland
7. Alex Fuchs, Consultant; University of Bern, Bern, Switzerland

Further Study Information

Current Stage: Ongoing
Date: September 2024 - September 2026
Funding source(s): Association of Anaesthetists/Anaesthesia via the National Institute for Academic Anaesthesia, UK


Health Area

Disease Category: Anaesthesia & pain control

Disease Name: Airway management

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention:

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Journal editors
- Researchers
- Service providers

Study Type

- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Delphi process
- Literature review
- Systematic review

We will perform a systematic review to identify candidate outcomes reported in ongoing and published randomised controlled trials and observational studies investigating airway management. This will be followed by an international modified Delphi study involving patients, clinicians, researchers, and other stakeholders. We will finalise the selection of the COS items, along with definitions for proposed measurement instruments and timings, at an international consensus meeting. We will follow the methodology recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative.

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