Suri 2001.
Methods | Open randomised controlled trial. Cross‐over design. Duration: 3 treatment periods of 12 weeks with a 2‐week wash out period between each period. Measurements were taken at the start and end of each 12‐week period. |
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Participants | 48 children randomised, 45 completed first treatment period, 44 completed the second treatment period and 40 completed the third treatment period. Age: range 7.3 ‐ 17 years. |
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Interventions | Treatment 1: 2.5 mg rhDNase once daily. Treatment 2: alternate day 2.5 mg rhDNase. Treatment 3: 5 mL 7% HS twice daily. |
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Outcomes | Primary outcome was FEV1; secondary outcomes were FVC, number of pulmonary exacerbations, weight gain, quality of life, exercise tolerance and the total costs of hospital and community care. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation was used. Randomisation carried out by telephone to an independent trials co‐ordinating unit, and stratified by hospital and balanced after each group of 12 children. |
Allocation concealment (selection bias) | Low risk | Independent trials co‐ordinator. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not blinded, due to the taste of the HS. Outcomes included subjective measures including quality of life therefore risk of bias considered high. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 48 children randomised, 45 completed 1st treatment period, 44 completed the 2nd treatment period and 40 completed the 3rd treatment period. Data analysed according to ITT principle |
Selective reporting (reporting bias) | Low risk | None identified. |
Other bias | Low risk | Cross‐over design with washout period of 2 weeks which should be adequate for lung function to return to baseline. |