Ballmann 2002.
Methods | Open pilot trial. Cross‐over design. Duration: 2 treatment periods of 3 weeks, with a 3‐week washout period. Participants were assessed before and after each period. |
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Participants | 14 participants (mean age 13.3 years) with mild to moderate pulmonary involvement. Withdrawals were not discussed within the paper. | |
Interventions | Treatment: 2 puffs salbutamol via a spacer prior to nebulisation of 2.5 mg dornase alfa once daily. Control: 2 puffs salbutamol via a spacer prior to nebulisation of 10 ml 5.85% HS once daily. |
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Outcomes | Change from baseline for FEV1 (% predicted), not clear if relative or absolute change. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but method not clear. |
Allocation concealment (selection bias) | Unclear risk | Method unclear. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not blinded, due to the taste of the hypertonic saline. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No discussion of whether ITT analysis performed. Withdrawals were not discussed within the paper. |
Selective reporting (reporting bias) | Low risk | None identified. |
Other bias | Low risk | Cross‐over design with washout period of 3 weeks which should be adequate for lung function to return to baseline. |