Ballmann 1998.
Study characteristics | ||
Methods | RCT. Design: cross‐over with 2 treatment periods of 3 weeks each and a washout period of 3 weeks in between. Location: Germany. |
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Participants | Total participants: n = 14, 8 males and 6 females.
FEV1 % predicted had to be greater than 40%. Baseline characteristics FEV1 % predicted: mean (SD) 75.6% (14%). Pseudomonas aeruginosa: chronic colonisation: n = 9; free: n = 3; intermittent: n = 2. |
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Interventions | Pre‐treated salbutamol 200 mcg MDI inhaled (2 puffs).
Group 1: 10 mL HS 5.85% 2x daily. Group 2: 2 mL Pulmozyme 2.5 mg 2x daily. Treatment was given via a Pari Master with Pari LL Routine medication not altered during trial. |
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Outcomes | Change in FEV1 as a % of predicted, nebulisation time, comparison of cost (in Deutschmarks), preference. | |
Notes | There was a 3‐week washout between interventions. No sample size calculation stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants randomised into groups of 4 and drew lots to start with HS or rhDNase. |
Allocation concealment (selection bias) | Unclear risk | No details provided as to how lots concealed allocation. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Taste of HS and difference in volume made blinding not possible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not discussed. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information provided whether an ITT was used. |
Selective reporting (reporting bias) | Low risk | All outcomes stated in the 'Methods' section reported in the 'Results' section. |
Other bias | Low risk | Washout period of 3 weeks. No sample size calculation stated. |