van Winden 1998.
Study characteristics | ||
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). |
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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. |
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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. |