Davies 2012.
Study characteristics | ||
Methods | RCT. Parallel design. Location: single centre in UK. Duration: median length of stay for controls was 14 days, median length of stay for HFCWO group was 13 days. |
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Participants | 36 participants with CF admitted to hospital with an acute infective pulmonary exacerbation. Mean (SD) age: HFCWO group 25.8 (7.3) years; control group 29.8 (1.7) years. Sex: 23 (64%) males. |
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Interventions | Intervention: HFCWO (device was the Vest®, Hill Rom Model 205), participants paused to huff and cough as necessary. Control: usual airway clearance techniques (including ACBT, AD, PEP, manual techniques or oscillating PEP), further details not given. Treatment given 4x daily ‐ 2x supervised by a physiotherapist and 2x carried out independently. |
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Outcomes | FEV1, FVC, length of hospital stay and sputum weight. Additional reference to this study also considered FEF25-75. |
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Notes | Abstracts only and entry on clinicaltrials.gov (NCT01057524) available ‐ no full paper. Further breakdown of data has been requested for inclusion in meta‐analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not discussed. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not blinded. Difficult to blind participants to a device trial, but assessors not blinded either and no reasons given for this. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No drop outs mentioned or missing data discussed. |
Selective reporting (reporting bias) | Unclear risk | All parameters stated as recorded were discussed over the 2 abstracts, but no full paper. |
Other bias | Unclear risk | Not discussed but there is a possibility of involvement of the manufacturers in provision of the Vest® devices for the 36 participants. |