What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials?
- Scichilone, N.
- Basile, M.
- Battaglia, S.
- Bellia, V.
DOIAbstract
BACKGROUND AND OBJECTIVE: We aimed to explore to what extent an unselected population of chronic obstructive pulmonary disease (COPD) outpatients would be eligible for inclusion in randomized clinical trials (RCTs). METHODS: Retrospective analysis of the clinical records of outpatient subjects with an ascertained diagnosis of COPD. COPD outpatients were assessed against the following inclusion criteria: 40 < age < 80 years, current or former smokers, forced expiratory volume in the first second (FEV1) <70% predicted, no long-term oxygen therapy, no other concomitant lung diseases and absence of major extrapulmonary comorbidities. The study consisted of 2 phases; in phase 1, the criteria for inclusion in RCTs on COPD were selected, and in ph...
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