{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T09:55:26Z","timestamp":1789552526818,"version":"build-2803163510"},"reference-count":25,"publisher":"S. Karger AG","issue":"1","license":[{"start":{"date-parts":[[2013,11,20]],"date-time":"2013-11-20T00:00:00Z","timestamp":1384905600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"},{"start":{"date-parts":[[2013,11,20]],"date-time":"2013-11-20T00:00:00Z","timestamp":1384905600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Respiration"],"published-print":{"date-parts":[[2014]]},"abstract":"<b><i>Background and Objective:<\/i><\/b> 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). <b><i>Methods:<\/i><\/b> 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 (FEV<sub>1<\/sub>) <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. <b><i>Results:<\/i><\/b> 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%), FEV<sub>1<\/sub> (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. <b><i>Conclusions:<\/i><\/b> 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 <i>pragmatic<\/i> trials in COPD to better modulate the application of results of RCTs to patients encountered in daily practice.<\/jats:p>","DOI":"10.1159\/000355082","type":"journal-article","created":{"date-parts":[[2013,11,20]],"date-time":"2013-11-20T13:12:37Z","timestamp":1384953157000},"page":"11-17","source":"Crossref","is-referenced-by-count":51,"title":["What Proportion of Chronic Obstructive Pulmonary Disease Outpatients Is Eligible for Inclusion in Randomized Clinical Trials?"],"prefix":"10.1159","volume":"87","author":[{"given":"Nicola","family":"Scichilone","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Basile","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salvatore","family":"Battaglia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"Bellia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2013,11,20]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1159\/000346025"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0030442"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2004.03.026"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2006.10.011"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.05.00034805"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1136\/jech.56.2.119"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa063070"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0805800"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1378\/chest.105.5.1411"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199906243402503"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)10019-3"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.320.7245.1297"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200012283432601"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.2112055"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(03)12459-2"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.03.00027003"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1378\/chest.124.3.834"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.03.00031402"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-146-8-200704170-00152"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.1136\/thx.2007.087213"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200707-973OC"},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60869-7"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)61255-1"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)61252-6"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2011.09.002"}],"container-title":["Respiration"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/355082","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/355082","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T18:05:19Z","timestamp":1745431519000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000355082"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,11,20]]},"references-count":25,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2014,1,1]]},"published-print":{"date-parts":[[2014,1,24]]}},"URL":"https:\/\/doi.org\/10.1159\/000355082","archive":["Portico"],"relation":{},"ISSN":["0025-7931","1423-0356"],"issn-type":[{"value":"0025-7931","type":"print"},{"value":"1423-0356","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,11,20]]}}}