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Respiration. 2014;87(1):11-7. doi: 10.1159/000355082. Epub 2013 Nov 20.

What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials?

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1
Dipartimento Biomedico di Medicina Interna e Specialistica, Sezione di Pneumologia, University of Palermo, Palermo, Italy.

Abstract

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 phase 2, the above criteria were applied to an unselected outpatient COPD population.

RESULTS:

A total of 578 subjects (83% of the whole group) failed at least one of the inclusion criteria. Lung diseases other than COPD (occurring in 30% of our population, mostly bronchiectasis), long-term oxygen therapy (31%), FEV1 (19%), age (14%) and extrapulmonary comorbidities such as cognitive impairment (14%), arrhythmias (17%) and congestive heart disease (13%) would have been the most frequent causes for exclusion from RCTs.

CONCLUSIONS:

In real-life settings, more than 80% of COPD subjects are currently treated by protocols based on results of RCTs for which they would not have been eligible. We encourage a more extensive use of pragmatic trials in COPD to better modulate the application of results of RCTs to patients encountered in daily practice.

PMID:
24281343
DOI:
10.1159/000355082
[Indexed for MEDLINE]
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