| Methods |
Randomised study comparing 2 doses of azithromycin. |
| Participants |
Children with CF (5‐18 years). 56/105 children screened were randomised, 47 completed 12 months follow‐up. |
| Interventions |
High (15 mg/kg/day) versus low (5 mg/kg/day) dose of azithromycin for 12 months. |
| Outcomes |
Change in FEV1 (% predicted), pulmonary exacerbation (hospitalisation), microbiology, antibiotic use. |
| Notes |
Children admitted if breathlessness or hypoxia occurred with exacerbation (suggests severe respiratory compromise). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated blocks of 4. |
| Allocation concealment (selection bias) |
Unclear risk |
Not clear if patients or physicians knew of allocation to high or low dose. |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
As above. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Primary outcome assessed on per protocol basis not ITT. |
| Selective reporting (reporting bias) |
High risk |
Only limited time points reported, patients seen monthly. All outcomes measured were reported, but not completely. |
| Other bias |
High risk |
More boys in the high‐dose group. |
