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. 2018 Sep 27;2018(9):CD001506. doi: 10.1002/14651858.CD001506.pub4

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.
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.
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.
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.