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. 2017 May 4;2017(5):CD006842. doi: 10.1002/14651858.CD006842.pub4
Methods RCT.
Cross‐over design (1‐week washout period). Location: single centre in the Netherlands.
Duration: 6 weeks (each treatment 2 weeks and 1 week wash in/wash out period).
Participants 22 participants with CF confirmed by sweat test or DNA mutation analysis. Mean age 12 years; range 7 ‐ 17 years.
Sex: 12 males, 10 females. Clinically stable for 2 weeks before study.
Interventions Flutter versus PEP mask. 2x daily, 2 weeks in each arm, 1 week wash‐in and wash‐out period.
Outcomes FVC, FEV₁, RV/TLC, FEF25‐75% predicted, participant satisfaction. Outcomes were all measured before and after each treatment intervention.
Notes Outcome assessor blinded.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised, but method not discussed.
Allocation concealment (selection bias) Unclear risk Not discussed.
Blinding (performance bias and detection bias) All outcomes Low risk Participants and clinicians could not be blinded, but outcome assessor was blinded.
Incomplete outcome data (attrition bias) All outcomes Low risk All participants completed the study and their data were included.
Selective reporting (reporting bias) Unclear risk Not clear what happened in the run‐in or wash out period between cross‐over.
Other bias Unclear risk None identified.