Bishop 2011.
| Methods | Randomised, blinded, cross‐over placebo‐controlled trial with 2‐week interventions, no washout. Measurements were taken at: ‐14; 0;14; and 28 days. Generation of allocation schedule and concealment of treatment allocation were clear. ITT analysis was used. | |
| Participants | 17 stable (monitored 2 weeks previously) adults randomised; mean (SD) age 27 years (range 19 years ‐ 67 years), mean (SD) FEV1 63 (23) % predicted (range 20% ‐ 97%). | |
| Interventions | Delivery 30 minutes before airway clearance techniques compared to delivery immediately after airway clearance. ACT= PEP or PD/percussion. Dornase alfa naive. | |
| Outcomes | FEV1, FVC, QOL (CFQ, VAS for well‐being, cough, sputum volume, ease of clearance). 24 hr wet sputum weight, VO2max (10 or 20 minute shuttle), adherence (diary), adverse events. |
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| Notes | Additional data from authors, manuscript pending publication (Bishop 2011). PEDro 9/10 (Eligibility criteria: yes; random allocation: yes; concealed allocation: yes; baseline comparability: yes; blind participants: yes; blind therapists: yes; blind assessors: yes; adequate follow‐up: yes; ITT analysis: yes; between‐group comparisons: yes; point estimates and variability: no). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Block randomisation by an independent was used. |
| Allocation concealment (selection bias) | Low risk | Independent distant pharmacy. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo used; participants, therapists and assessors blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Raw data available. |
| Selective reporting (reporting bias) | Low risk | QOL, 24 hr wet sputum weight, VO2max, adherence and adverse events were reported as non‐significant in the publication but data were not provided by authors. |