Milne 2004.
Study characteristics | ||
Methods | RCT (pilot study).
Cross‐over design (1 day washout between 2 treatment arms).
Location; single‐centre in South Africa. Duration: 5 days (2 days per treatment with 1 day washout in between). |
|
Participants | 7 participants with CF; mean age 28 years (range 16 ‐ 42 years). | |
Interventions | Flutter versus ACBT. Group A: flutter, then washout, then ACBT. Group B: ACBT, then washout, then flutter. | |
Outcomes | Daily 24‐hour sputum samples and lung function tests (FEV1, FVC, PEF, FEF25, FEF50, FEF75), questionnaire at end of study. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised to either one group or another but generation of sequence not discussed. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) All outcomes | High risk | Additional person was used to perform the lung function tests and is included in the acknowledgements it is not clear if this person was blinded to the treatments. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data sets were complete for all those participants included in the study. |
Selective reporting (reporting bias) | Unclear risk | No major side effects were experienced with either technique. |
Other bias | Low risk | Possible limitations of the study were discussed and the author suggested various means to improve the findings of the study. |