van der Giessen 2007a.
| Methods | Randomised, blinded, cross‐over placebo‐controlled trial with 3‐week interventions, no washout. Measurements were taken at 0, 14, 21, 35 and 42 days. Generation of allocation schedule and concealment of treatment allocation were unclear. ITT analysis was not used. | |
| Participants | 25 stable (no IV treatment 1 month previously) children randomised: mean age 12 years (range 7 years ‐ 19 years), mean FEV1 88% predicted. One child dropped out while inhaling dornase alfa before airway clearance. | |
| Interventions | Delivery 30 minutes before airway clearance techniques compared to delivery immediately after airway clearance. ACT = PEP mask in 75%, Flutter in 13%, ACBT in 4%, AD in 4% and combination 4%. Maintenance dornase alfa. | |
| Outcomes | FEV1, FVC, symptom scores (VAS for cough and CSS day & night, sputum viscosity and amount). FEF25‐75, FEF25, Rint, adherence (vials), adverse events. |
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| Notes | PEDro 8/10 (eligibility criteria: yes; random allocation: yes; concealed allocation: no; baseline comparability: yes; blind participants: yes; blind therapists: yes; blind assessors: yes; Adequate follow‐up: yes; ITT analysis: no; between‐group comparisons: yes; point estimates and variability: yes). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stated as randomised but no method was described. |
| Allocation concealment (selection bias) | Unclear risk | Method unclear. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo used; participants, therapists and assessors blinded. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Not analysed as ITT, one drop out due to exacerbation. |
| Selective reporting (reporting bias) | Low risk | Adherence data were only provided for the whole trial cohort and not by trial arm. |