Gondor 1999.
| Study characteristics | ||
| Methods | RCT. Parallel design. Location: single centre in USA. Duration: length of hospital stay (2 weeks). |
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| Participants | 23 participants enrolled, 3 participants excluded due to being discharged prior to 14 days of inpatient stay. Data from 20 participants (11 males, 9 females) with CF, enrolled on admission to hospital. Age 5 ‐ 21 years. | |
| Interventions | 2‐week intervention of either flutter (n = 12) or CPT (n = 8). Frequency during the day was not specified. | |
| Outcomes | SaO₂, exercise tolerance (as measured by the 6MWD) and FEF, FVC and FEV1 were measured at entry, day 7 and day 14. | |
| Notes | 20 participants included but two of them refused to walk so the data are from 18 participants – but the paper does not state which group(s) the two belonged to who dropped out, so "n" is unknown for each group in this outcome. Data have been recorded in the analysis using the numbers originally in each group therefore there may be bias attributed to one or other group as it is not clear which participants would not perform the walk test. SaO₂ was monitored during admission but no other data were reported for this parameter, apart from P < 0.05 by day 14. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Sequence generation not discussed. |
| Allocation concealment (selection bias) | Unclear risk | Not discussed. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Pulmonary function and exercise technicians were blinded as to which treatment interventions the participants were receiving. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 3 participants excluded due to being discharged prior to 14 days of inpatient stay, therefore not all their data were collected. |
| Selective reporting (reporting bias) | Unclear risk | Not possible to compare original trial protocol with final paper. Additionally the lung function parameters are not identified and may not be those frequently observed. SaO₂ was monitored during admission but no other data were reported for this parameter, apart from P < 0.05 by day 14. |
| Other bias | Unclear risk | Scandipharm Pharmaceuticals were thanked by the authors for providing the flutter valves. |