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Table 3 Progression criteria (based on feasibility parameters)

From: Mechanical insufflation-exsufflation to promote extubation success in critically ill adults on intensive care: protocol for a randomised controlled feasibility trial

 

Summary

Action required

Go (green)

Recruitment: > 70% expected recruitment target

Follow-up: > 75% data completeness

Adherence: > 75% adherence to intervention

Feasible to continue to main trial

Amend (amber)

Recruitment: 50–70% of expected recruitment target

Follow-up: 65–75% data completeness

Adherence: 65–75% adherence to intervention

Identify remediable factors; discuss with trial management group

Stop (red)

Recruitment: < 50% of expected recruitment target

Follow-up: < 65% data completeness

Adherence: < 65% adherence to intervention

Do not progress to main trial, unless there is a strong case that unanticipated remediable factors have been identified