Dodd 2000.
Methods | Randomised, double‐blind placebo‐controlled trial. Cross‐over design. Duration: 2 treatment periods of 14‐days with a 7‐day wash out period between each period. Measurements were taken at the beginning and end of each treatment period. |
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Participants | 23 participants randomised. Age: (mean) 27.5 years. Withdrawals were not discussed within the paper. Disease severity was not discussed. |
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Interventions | Treatment: 2.5 mg rhDNase once daily. Control: 2.5 ml 0.9% saline once daily. |
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Outcomes | FEV1. | |
Notes | Raw data provided; however no data legend therefore unable to analyse, FEV1 not reported in abstract. | |
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 | Described as double blind, no further details. |
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 | High risk | Cross‐over trial with 7‐day washout period, which is not long enough for lung function to return to baseline; however data from this trial were not available for analysis in this review. |