Dentice 2016.
Study characteristics | ||
Methods | RCT. Design: parallel. Duration: 3‐day study which began towards the end of hospitalisation for an exacerbation (approximately 14 days) with follow‐up for 1 year. If re‐admission within that year, participant invited to repeat 3‐day study. Location: Australian multicentre trial. |
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Participants | 132 adults with CF admitted to hospital with a respiratory exacerbation. Age: mean (SD) 28 (9) years. 49% were female. FEV1 % predicted: mean (SD) 48 (20)%. |
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Interventions |
Group 1: 3x daily nebulisation of 4 mL HS 7%. Group 2: IS 0.12% (taste‐masked). Treatment was administered via Pari LC with jet nebuliser Interventions given immediately before or during physiotherapy. |
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Outcomes | Length of hospital stay, lung function, oxygenation, bacterial load, symptom scores, QoL, exercise tolerance, time to relapse. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Done sequentially upon admission. |
Allocation concealment (selection bias) | High risk | Allocation was sequential. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Taste of intervention and control masked by quinine. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators blinded to intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop outs. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Low risk | None apparent. |