Development of a core outcome set for trials of airway clearance interventions in the critically ill

Airway clearance techniques comprise an important component of airway care, facilitating and enhancing mucociliary clearance to prevent secretion encumbrance. Identification of effective and safe interventions to optimise airway clearance in the critically ill is paramount. All mechanically ventilated critically ill patients require airway clearance. Furthermore, sub-optimal airway clearance and resultant retained secretions predispose patients to a higher risk of ventilator acquired pneumonia and extubation failure. To inform evidence-based clinical decisions, results from individual airway clearance intervention trials need to be compared and synthesized. However, in the absence of a core outcome set (COS), important barriers to evidence synthesis remain.

Contributors

Prof Louise Rose (London, UK) (PI);
Ema Swingwood (Bristol, UK);
Prof Frederique Paulus (Amsterdam, Netherlands);
Willemke Stilma (Amsterdam, Netherlands)

Further Study Information

Current Stage: Completed – pending publication
Date: January 2022 - February 2025
Funding source(s): tbc


Health Area

Disease Category: Lungs & airways

Disease Name: Critical illness , Acute respiratory failure

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Other

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Service providers
- Service users

Study Type

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

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Systematic review


Item generation

1. Systematic Review: we will extract data on primary and secondary outcomes reported, measures used and measurement time-points from studies. This process has already started.

2. Interviews with key stakeholders and end users including patients and family members: we will conduct qualitative interviews with patients, family members and other relevant stakeholders as to outcomes they consider important to measure in future studies of airway care interventions in adults requiring an artificial airway with or without mechanical ventilator support.


Consensus Building

1. We will conduct a modified Delphi study to establish consensus on outcomes for inclusion in a core outcome set. We will recruit an international expert panel representing key stakeholders and end users including former patients and family members.

2. If consensus on a core outcome set is not achieved via the Delphi process, we will host a virtual consensus meeting using nominal group technique and voting to establish the core outcomes.

3. We will hold a second virtual consensus meeting using nominal group technique and voting to establish appropriate measures for the core outcomes.

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