Oermann 2001.
Study characteristics | ||
Methods | RCT. Cross‐over design (2‐week washout period). Location: multicentre (3 centres) in USA. Duration: 12 weeks (2‐week run in period followed by 4‐week treatment and 2‐week washout with alternative 4‐week treatment). |
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Participants | 29 participants enrolled (14 males). Aged 6 years or greater. Mean (range) age ‐ 23 (9 to 39) years. Diagnosis of CF confirmed by sweat test. Required ability to reliably perform spirometry and lung volume measurements, to have baseline FVC of 50 ‐ 80 % predicted and be clinically stable for 1 month prior to enrolment. Excluded if in concurrent study or history of massive haemoptysis within 1 month or pneumothorax within 6 months of entrance. 5 participants withdrew (4 exited due to illness and 1 due to non‐compliance with clinic visits). | |
Interventions | HFCWO versus oscillating PEP (flutter). As prescribed previous to study ‐ no mention whether this was 2x daily etc. 4 weeks in each arm, 2‐week lead‐in and wash out periods during which time they resumed their normal routine therapies which were not outlined. | |
Outcomes | FEV1, FVC, FEF25-75%, participant satisfaction scores in domains of efficacy, convenience and comfort. Participant preference was measured as baseline and pre/post each intervention (5 data points). | |
Notes | 5 withdrawals, ITT was identified. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Prospective randomisation, further details not given on method. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not discussed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 participants withdrew (4 exited due to illness and 1 due to non‐compliance with clinic visits). ITT identified. |
Selective reporting (reporting bias) | High risk | Only participants who completed both therapies were included in the final analysis. As we do not know what their normal therapy was perhaps they had already done a comparison? |
Other bias | Unclear risk | None identified. |