| Comparison 8. Inhaled colistin + oral ciprofloxacin versus inhaled tobramycin + oral ciprofloxacin for acute infection with P aeruginosa | ||||||
|---|---|---|---|---|---|---|
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Inhaled tobramycin + oral ciprofloxacin | Inhaled colistin + oral ciprofloxacin | |||||
| Relative change in % predicted FEV1 from baseline Follow-up: 54 days | The mean relative change in % predicted FEV1 from baseline in the control groups was 2.15 | The mean relative change in % predicted FEV1 from baseline in the intervention groups was 2.4 lower (5.885 lower to 1.0855 higher) | 128 (Taccetti 2012) | ⊕⊝⊝⊝ very low1,2 | ||
| Treatment failure - trial discontinuation due to Lack of compliance Follow-up: 28 days | 110 per 1000 | 105 per 1000 (50 to 224) | RR 0.95 (0.45 to 2.03) | 223 (Taccetti 2012) | ⊕⊝⊝⊝ very low1,3,4 | |
| Adverse events - Vomiting Follow-up: 28 days | 17 per 1000 | 9 per 1000 (1 to 104) | RR 0.56 (0.05 to 6.11) | 223 (Taccetti 2012) | ⊕⊝⊝⊝ very low1,5 | |
| Adverse events - Photosensitivity Follow-up: 28 days | 0 per 1000 | 0 per 1000 (0 to 0) | RR 3.37 (0.14 to 81.79) | 223 (Taccetti 2012) | ⊕⊝⊝⊝ very low1,5 | |
| Adverse events - Wheeze Follow-up: 28 days | 8 per 1000 | 3 per 1000 (0 to 77) | RR 0.37 (0.02 to 9.09) | 223 (Taccetti 2012) | ⊕⊝⊝⊝ very low1,5 | |
| Adverse events leading to trial discontinuation - Pulmonary exacerbation during early eradication treatment leading to treatment failure Follow-up: 28 days | 42 per 1000 | 38 per 1000 (11 to 138) | RR 0.9 (0.25 to 3.26) | 223 (1 study) | ⊕⊝⊝⊝ very low1,4 | |
The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
Abbreviations: CI: confidence interval; FEV1: forced expiratory volume in 1 second; IV: intravenous; RR: risk ratio
The quality of the evidence was downgraded by 1 due to serious imprecision as there was no blinding (openlabel).
The quality of the evidence was downgraded by 2 due to serious imprecision as 95% CI crosses two clinical MIDs.
The quality of the evidence was downgraded due to indirect outcome for discontinuation due to adverse events. It is unclear if discontinuation is due to adverse events or other factors.
The quality of the evidence was downgraded by 2, as the 95% CI crossed the null effect and the CI was very wide
The quality of the evidence was downgraded by 2 due to serious imprecision as 95% CI crosses 2 default MIDs.
From: 9, Pulmonary monitoring, assessment and management
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