title: Eligibility of real-life patients with COPD for inclusion in RCTs: a commentary.
abstract: Randomized clinical trials (RCTs) are performed to provide evidence to support treatment decisions. Based on the nature of those studies and the need to avoid confounding factors, it has been argued that the population selected in RCTs only partially represents the real-life population. This assumption casts doubts on the applicability of the results provided by RCTs in the management of individuals with an established diagnosis of COPD, and advocates the need for complementary studies with a pragmatic design. Herein, we comment on the recent article published by Halpin and colleagues on the Journal [Halpin et al, Respir Res 17:120, 2016], in which higher rates of inclusions in RCTs for COPD are found compared to previous observations. By analyzing the design of the studies and the end results, we conclude that the accumulating evidence contribute to shed lights on how representative is the outpatient population of real life settings.
authors.affiliation: DIBIMIS, University of Palermo, Palermo, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Battaglia
authors.affiliation: DIBIMIS, University of Palermo, Palermo, Italy. nicola.scichilone@unipa.it.
authors.forename: Nicola
authors.identifier: 0000-0001-6400-6573
authors.initials: N
authors.lastname: Scichilone
mesh_terms: D004608:Eligibility Determination / Q000379:methods*; D006801:Humans; D018579:Patient Selection; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
keywords: COPD research; Clinical practice; Clinical trials