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) 1 (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 2014
Externally publishedYes

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Chronic Obstructive Pulmonary Disease
Outpatients
Randomized Controlled Trials
Pragmatic Clinical Trials
Forced Expiratory Volume
Comorbidity
Cardiac Arrhythmias
Heart Diseases
Population

Keywords

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

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials. / Scichilone, Nicola; Basile, Marco; Battaglia, Salvatore; Bellia, Vincenzo.

In: Respiration, Vol. 87, No. 1, 01.2014, p. 11-17.

Research output: Contribution to journalArticle

Scichilone, Nicola ; Basile, Marco ; Battaglia, Salvatore ; Bellia, Vincenzo. / What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials. In: Respiration. 2014 ; Vol. 87, No. 1. pp. 11-17.
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