Pedersen 1986.
Study characteristics | ||
Methods | RCT.
Cross‐over design ‐ 3 months in between treatment arms. Duration: 14‐day course. Elective regimen. |
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Participants | 20 participants; 3 drop outs, 17 completed trial. Age, mean: 12.6 years. Gender split: 10 male, 10 female. PsA colonised. |
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Interventions | Single antibiotic: ceftazidime 150 mg/kg/day, 8‐hourly. Combination antibiotic: ceftazidime plus tobramycin 10 mg/kg/day, 8‐hourly. |
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Outcomes | Lung function, inflammatory markers, development of resistant strains. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no details of method given. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Both interventions given with same volume and in same way. NJ: described as an open study ‐ so I interpret this to mean no blinding?? |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 participants excluded ‐ reasons given (bacteriological resistance developed between treatment arms in 2 participants and a 3rd withdrew on first day of 2nd treatment arm due to nausea). |
Selective reporting (reporting bias) | Low risk | Outcomes stated in the methods section reported in the results. |
Other bias | Low risk | None identified. |