Summary of findings 1. Summary of findings.
Biofilm antimicrobial susceptibility testing compared with standard antimicrobial susceptibility testing for guiding antibiotic therapy in cystic fibrosis | ||||||
Patient or population: adults and children with cystic fibrosis and P aeruginosa Settings: outpatients Intervention: antibiotics chosen on the basis of biofilm antimicrobial susceptibility testing Comparison: antibiotics chosen on the basis of standard antimicrobial susceptibility testing | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Standard antimicrobial susceptibility testing | Biofilm antimicrobial susceptibility testing | |||||
FEV1 change from start of treatment (L) Follow‐up: 14 days |
The mean change in FEV1 ranged across control groups from 0.12 L to 2.75 L. | The mean change in FEV1 in the intervention groups was 0.04 L higher (0.08 L lower to 0.16 L higher). | NA | 68 (2) | ⊕⊕⊕⊕ high | |
FEV1 change from start of treatment (% predicted) Follow‐up: 14 days |
The mean (SD) change in FEV1 in the control group was 9.62 (10.12)% predicted. | The mean change in FEV1 in the intervention groups was 2.47% lower (9.29% lower to 4.34% higher). | NA | 34 (1) | ⊕⊕⊕⊝ moderatea | Data provided by the authors for this outcome. |
Time to next exacerbation Follow‐up: 5 years |
The median time to subsequent exacerbation was 185 days in the standard testing group and 162 days in the biofilm group. The difference in survival curves was not significant (P = 0.8). The HR for subsequent exacerbation also showed no significant difference between groups, HR 0.54 (95% CI 0.25 to 1.16). |
NA | 39 (1) | ⊕⊕⊕⊝ moderatea | ||
Adverse events: number of moderate adverse events Follow‐up: duration of antibiotic treatment (14 days) |
129 per 1000 | 46 per 1000 (9 to 228) | RR 0.36 (0.07 to 1.77) | 73 (2) | ⊕⊕⊕⊝ moderateb | There was no significant difference in the number of mild events between standard or biofilm groups. There were no severe adverse events observed in either group. |
Sputum density: change in P aeruginosa sputum density (log1₀ CFU/g) Follow‐up: 14 days |
The mean change in sputum density ranged across control groups from ‐3.27 to ‐3.83 log1₀ CFU/g. | The mean change in sputum density in the intervention groups was 0.8 log1₀ CFU/g higher (0.59 log1₀ CFU/g lower to 2.18 log1₀ CFU/g higher). | NA | 70 (2) | ⊕⊕⊕⊕ high | |
Quality of life: change in CFQ‐R score from start of treatment Follow‐up: 14 days |
The mean change in CFQ‐R score in the control group was 26.39 points. | The mean change in CFQ‐R score in the intervention group was 15.04 points lower (15.04 points lower to 1.71 points lower. | NA | 38 (1) | ⊕⊕⊕⊝ moderatea | There was a significant difference in change in CFQ‐R scores between groups (P = 0.03) favouring the standard susceptibility testing group. |
*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). CFQ‐R: Cystic Fibrosis Questionnaire ‐ Revised; CFU: colony forming units; CI: confidence interval; FEV1: forced expiratory volume in 1 second; HR: hazard ratio; P aeruginosa : Pseudomonas aeruginosa; RR: risk ratio; SD: standard deviation. | ||||||
GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. |
a Downgraded once due to small number of participants from 1 trial. b Downgraded once due to imprecision: low event rates resulting in wide CIs.