Table 2 Limitations of published placebo-controlled antibiotic trials in acute exacerbations of chronic obstructive pulmonary disease
Limitation of study design | Potential consequences |
|---|---|
Small number of subjects | Type 2 error |
Subjects with mild or no underlying chronic obstructive pulmonary disease included | Diminished overall perceived efficacy of antibiotics |
Non-bacterial exacerbations included | Type 2 error |
End-points compared at 3 weeks after onset | Spontaneous resolution mitigates differences between arms |
| Â | Clinically irrelevant as most decisions about antibiotic efficacy are made earlier |
Speed of resolution not measured | Clinically relevant end-point not assessed |
Lack of long-term follow-up | Time to next exacerbation not assessed |
Antibiotic resistance to agents with limited in vitro antimicrobial efficacy | Diminished overall perceived efficacy of antibiotics |
Poor penetration of antibiotics into respiratory tissues | Diminished overall perceived efficacy of antibiotics |
Concurrent therapy not controlled | Undetected bias in use of concurrent therapy |