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.
The present systematic review and meta-analysis supports the hypothesis that in patients with MV-CAD presenting with STEMI undergoing primary PCI, a staged multivessel revascularization strategy may improve early and late survival.
Background/Objective: This study was aimed at exploring to what extent populations enrolled in randomized controlled trials (RCTs) of inhalation combination treatment for mild/moderate asthma in adults are fully representative of ‘real-life' populations. The following is a retrospective analysis of the clinical records of outpatient subjects with an ascertained diagnosis of asthma. Methods: A retrospective analysis was performed. Stable conditions, such as smoking habit and chronic diseases other than asthma, were identified as exclusion criteria for RCTs. The selected criteria were then applied to asthmatic outpatients, yielding a population that was potentially eligible for RCTs. Results: Out of 1,909 subjects, 824 (43.2%) met at least one of the exclusion criteria for RCTs. Cigarette smoking (occurring in 34.3% of the entire population), lung diseases other than asthma (5.0%), anxiety and depression (3.3%), arrhythmias (2.3%), and coronary artery disease (1.2%) would have been the most frequent causes for exclusion from RCTs. The proportion of patients excluded from RCTs appears to increase with age, reaching 57.1% in patients aged >85 years. Conclusions: In a real-life setting, >40% of subjects with mild/moderate asthma are currently treated by protocols based on the results of RCTs for which they would not have been eligible. This proportion increases in elderly patients with comorbidities. These findings limit the generalizability of RCTs and advocate that complementary pragmatic studies be conducted.
Background: Despite bronchoscopic lung volume reduction (BLVR) with valves is a minimally invasive treatment for emphysema, it can associate with some complications. We aimed at evaluating the rate and type of complications related to valve treatment and their impact on clinical outcomes. Methods: It is a retrospective multicenter study including all consecutive patients with severe heterogeneous emphysema undergoing BLVR with endobronchial valve treatment and developed any complications related to this procedure. The type of complication, the time of onset, the treatment required and the outcome were evaluated. Response to treatment was assessed according to the minimal clinically important difference (MCID) as follows: an improvement of ≥15% in forced expiratory volume in one second (FEV 1); of −8% in residual volume (RV); of ≥26 m in 6-minnute walking distance (6MWD); and of ≥4 points on the St. George's Respiratory Questionnaire (SGRQ). Target lobe volume reduction (TLVR) ≥350 mL was considered significant. Results: One hundred and seven out of 423 (25.3%) treated patients had complications related to valve treatment including pneumothorax (17.3%); pneumonia (1.7%), chronic obstructive pulmonary disease (COPD) exacerbation (0.9%), respiratory failure (1.4%), valve migration (2.1%), and hemoptysis (1.9%). In all cases complications resolved with appropriate treatment including removal of valves in 21/107 cases (19.6%). Patients with TLVR ≥350 mL (n=64) vs. those <350 mL (n=43) had a statistically significant higher improvement in FEV 1 (19.0%±3.9% vs. 3.0%±0.9%; P=0.0003); in RV (−10.0%±4.8% vs. −4.0%±2.9%; P=0.002); in 6MWD (33.0±19.0 vs. 12.0±6.3 metres; P=0.001); and in SGRQ (−15.0±2.9 vs. −8.0±3.5 points; P=0.01). Only patients with TLVR ≥350 mL met or exceeded the MCID cutoff criteria for FEV 1 (19.0%±3.9%), RV (−10.0%±4.8%), 6MWT (33.0±19.0 metres), and SGQR (−15.0±2.9 points). Five patients (1.2%) died during follow-up for causes not related to valves treatment neither to any of the complications described.
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