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

Nicola Scichilone, Marco Basile, Salvatore Battaglia, Vincenzo Bellia

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)11-17
Number of pages7
JournalRespiration
Volume87
Issue number1
DOIs
StatePublished - Jan 1 2014

Keywords

  • Chronic obstructive pulmonary disease
  • Inclusion criteria
  • Randomized clinical trial

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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