Robinson 1997.
Methods | Randomised controlled trial. Design: cross‐over with 4 arms (no information on any washout period). Duration: each intervention given on 1 study day. Location: Australia. |
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Participants | Total participants: n = 10, 7 males and 3 females. Age mean (SD) (range): 22.1 (3.8) (19 ‐ 28) years. FEV1 % predicted mean (SD) (range): 52.0% (6.7) (31 ‐ 84%). All participants were chronically colonisedPseudomonas aeruginosa. In addition, 5 of the participants had Staphylococcus aureus. Participants in a stable clinical condition and baseline medications were not altered throughout the trial period. |
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Interventions | Pre‐treated with nebulised salbutamol 5 mg in 2.5 mL saline via an ultrasonic nebuliser. Group 1: HS 3% single dose. Group 2: HS 7% single dose. Group 3: HS 12% single dose. Group 4: Voluntary cough and IS combined as the control. Each participant took part in each arm. |
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Outcomes | Sputum isotope % clearance at 30 minutes, sputum isotope clearance at 90 minutes, mucociliary clearance. | |
Notes | No sample size calculation stated. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No detail provided. |
Allocation concealment (selection bias) | High risk | There was no random allocation to treatment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants could discern taste for intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not discussed. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No discussion of whether an intention‐to‐treat analysis had been used or of any withdrawals. |
Selective reporting (reporting bias) | Low risk | All outcomes stated in the methods were described in the results. |
Other bias | High risk | Washout period not clear. No sample size calculation stated. The time course of the effect of the interventions on the outcomes is not clear. |