Dingemans 2018b.
Study characteristics | ||
Methods | RCT. Cross‐over design. Location: single centre in Belgium. Duration: approximately 9 months. |
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Participants | 4 participants with CF. Admitted for administration of IV antibiotics for respiratory exacerbation. | |
Interventions | 3 different techniques. Each regimen was 30‐minute treatments of the randomised intervention 2x daily over 5 ‐ 10 days in hospital. This was followed by a washout of 3 months during which participants continued with AD. Intervention 1: AD alone. Intervention 2: IPV at medium frequency (200 bursts per minute ‐bpm) combined with AD. Intervention 3: IPV at high frequency (400 bursts per minute‐bpm) combined with AD. |
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Outcomes | Sputum for bacterial load‐ considering biofilm behaviour. FEV1 percentage change from baseline in FEV1 % predicted. FVC percentage change from baseline in FVC % predicted. |
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Notes | THIS DUPLICATE REFERENCE HAS BEEN CREATED TO ALLOW DATA FOR BOTH FREQUENCIES of IPV TO BE ENTERED IN THE ANALYSIS. This study ID refers to the 400 bpm frequency section of the study INTERVENTON 3. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study was randomised but sequence generation not described. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Blinding was stated, laboratory staff were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop outs but only 4 participants included in trial. |
Selective reporting (reporting bias) | Low risk | All parameters ( lung function, bacterial load and gene expression) identified and recorded were discussed. |
Other bias | Unclear risk | None identified. |