Homnick 1998.
Study characteristics | ||
Methods | Quasi‐RCT (alternate allocation). Cross‐over design. Location: single centre in USA. Duration: length of hospitalisation. |
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Participants | 22 enrolled into study, the data for 33 hospitalisations (20 males, 13 females) presented. Mean (range) age: 12 (7‐ 44) years. CF confirmed by sweat test and/or genetic testing. | |
Interventions | 4x daily flutter (each treatment was 15 min) versus 4x daily CPT (each treatment was 30 min). | |
Outcomes | Change from baseline FVC, FEV1, FEF25-75, FEV1/FVC, TLC, RV, RV/TLC. Measured at admission and discharge which was mean (SD) 8.9 (2.5) days of treatment in the flutter arm and 8.8 (2.4) days in the CPT arm. | |
Notes | Although 22 participants enrolled into the study, data were collected for 33 hospitalisations over the study period therefore baseline demographics may include some duplication of data. Subgroup analyses of 15 participants with only one admission and the initial admission of 7 were done with no change from overall outcome of the total 33 data sets analysed. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Initial participant randomised, but not stated how. Others followed alternating schedule. |
Allocation concealment (selection bias) | High risk | Alternate assignment. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Open label. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop outs reported. |
Selective reporting (reporting bias) | High risk | Although 22 participants enrolled into the study the data were collected for 33 hospitalisations over the study period therefore baseline demographics may include some duplication of data. Subgroup analyses of 15 participants with only one admission and the initial admission of 7 were done with no change from overall outcome of the total 33 data sets analysed. |
Other bias | Low risk | Participants were monitored for side effects including haemoptysis, hypoxia and pneumothorax but none were identified. |