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      Adherence to GOLD guidelines in real-life COPD management in the Puglia region of Italy

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          Abstract

          Background

          COPD is a disease associated with significant economic burden. It was reported that Global initiative for chronic Obstructive Lung Disease (GOLD) guideline-oriented pharmacotherapy improves airflow limitation and reduces health care costs. However, several studies showed a significant dissociation between international recommendations and clinicians’ practices. The consequent reduced diagnostic and therapeutic inappropriateness has proved to be associated with an increase in costs and a waste of economic resources in the health sector. The aim of the study was to evaluate COPD management in the Puglia region. The study was performed in collaboration with the pulmonology centers and the Regional Health Agency (AReS Puglia).

          Methods

          An IT platform allowed the pulmonologists to enter data via the Internet. All COPD patients who visited a pneumological outpatient clinic for the first time or for regular follow-ups or were admitted to a pneumological department for an exacerbation were considered eligible for the study. COPD’s diagnosis was confirmed by a pulmonologist at the moment of the visit. The project lasted 18 months and involved 17 centers located in the Puglia region.

          Results

          Six hundred ninety-three patients were enrolled, evenly distributed throughout the region. The mean age was 71±9 years, and 85% of them were males. Approximately 23% were current smokers, 63% former smokers and 13.5% never smokers. The mean post-bronchodilator forced expiratory volume in 1 second was 59%±20% predicted. The platform allowed the classification of patients according to the GOLD guidelines (Group A: 20.6%, Group B: 32.3%, Group C: 5.9% and Group D: 39.2%), assessed the presence and severity of exacerbations (20% of the patients had an exacerbation defined as mild [13%], moderate [37%] and severe [49%]) and evaluated the appropriateness of inhalation therapy at the time of the visit. Forty-nine percent of Group A patients were following inappropriate therapy; in Group B, 45.8% were following a therapy in contrast with the guidelines. Among Group C patients, 41.46% resulted in triple combination therapy, whilê14% of Group D patients did not have a therapy or were following an inappropriate therapy. In conclusion, 30% of all patients evaluated had been following an inadequate therapy. Subsequently, an online survey was developed to inquire about the reasons for the results obtained. In particular, we investigated the reasons why 30% of our population did not follow the therapy suggested by the GOLD guidelines: 1) why was there an excessive use of inhaled corticosteroids, 2) why a significantly high percentage was inappropriately treated with triple therapy and 3) why a consistent percentage (11%) of Group D patients were not treated at all.

          Conclusion

          The data provides an overview on the management of COPD in the region of Puglia (Italy) and represents a resource in order to improve appropriateness and reduce the waste of health resources.

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          Most cited references 22

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          GOLD 2011 disease severity classification in COPDGene: a prospective cohort study.

          The 2011 GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease [COPD]) consensus report uses symptoms, exacerbation history, and forced expiratory volume (FEV1)% to categorise patients according to disease severity and guide treatment. We aimed to assess both the influence of symptom instrument choice on patient category assignment and prospective exacerbation risk by category. Patients were recruited from 21 centres in the USA, as part of the COPDGene study. Eligible patients were aged 45-80 years, had smoked for 10 pack-years or more, and had an FEV1/forced vital capacity (FVC) <0·7. Categories were defined with the modified Medical Research Council (mMRC) dyspnoea scale (score 0-1 vs ≥2) and the St George's Respiratory Questionnaire (SGRQ; ≥25 vs <25 as a surrogate for the COPD Assessment Test [CAT] ≥10 vs <10) in addition to COPD exacerbations in the previous year (<2 vs ≥ 2), and lung function (FEV1% predicted ≥50 vs <50). Statistical comparisons were done with k-sample permutation tests. This study cohort is registered with ClinicalTrials.gov, number NCT00608764. 4484 patients with COPD were included in this analysis. Category assignment using the mMRC scale versus SGRQ were similar but not identical. On the basis of the mMRC scale, 1507 (33·6%) patients were assigned to category A, 919 (20·5%) to category B, 355 (7·9%) to category C, and 1703 (38·0%) to category D; on the basis of the SGRQ, 1317 (29·4%) patients were assigned to category A, 1109 (24·7%) to category B, 221 (4·9%) to category C, and 1837 (41·0%) to category D (κ coefficient for agreement, 0·77). Significant heterogeneity in prospective exacerbation rates (exacerbations/person-years) were seen, especially in the D subcategories, depending on the risk factor that determined category assignment (lung function only [0·89, 95% CI 0·78-1·00]), previous exacerbation history only [1·34, 1·0-1·6], or both [1·86, 1·6-2·1; p<0·0001]). The GOLD classification emphasises the importance of symptoms and exacerbation risk when assessing COPD severity. The choice of symptom measure influences category assignment. The relative number of patients with low symptoms and high risk for exacerbations (category C) is low. Differences in exacerbation rates for patients in the highest risk category D were seen depending on whether risk was based on lung function, exacerbation history, or both. National Heart, Lung, and Blood Institute, and the COPD Foundation through contributions from AstraZeneca, Boehringer Ingelheim, Novartis, and Sepracor. Copyright © 2013 Elsevier Ltd. All rights reserved.
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            The economic impact of exacerbations of chronic obstructive pulmonary disease and exacerbation definition: a review.

            Chronic obstructive pulmonary disease (COPD) poses a significant economic burden on society, and a substantial portion is related to exacerbations of COPD. A literature review of the direct and indirect costs of COPD exacerbations was performed. A systematic search of the MEDLINE database from 1998-2008 was conducted and supplemented with searches of conference abstracts and article bibliographies. Articles that contained cost data related to COPD exacerbations were selected for in-depth review. Eleven studies examining healthcare costs associated with COPD exacerbations were identified. The estimated costs of exacerbations vary widely across studies: $88 to $7,757 per exacerbation (2007 US dollars). The largest component of the total costs of COPD exacerbations was typically hospitalization. Costs were highly correlated with exacerbation severity. Indirect costs have rarely been measured. The wide variability in the cost estimates reflected cross-study differences in geographic locations, treatment patterns, and patient populations. Important methodological differences also existed across studies. Researchers have used different definitions of exacerbation (e.g., symptom- versus event-based definitions), different tools to identify and measure exacerbations, and different classification systems to define exacerbation severity. Unreported exacerbations are common and may influence the long-term costs of exacerbations. Measurement of indirect costs will provide a more comprehensive picture of the burden of exacerbations. Evaluation of pharmacoeconomic analyses would be aided by the use of more consistent and comprehensive approaches to defining and measuring COPD exacerbations.
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              How far is real life from COPD therapy guidelines? An Italian observational study.

              According to the GOLD international guidelines, the treatment of chronic obstructive pulmonary disease (COPD) should be proportional to the severity of airflow obstruction graded according to FEV(1)% predicted. Regular treatment with long-acting bronchodilators should be prescribed for symptomatic patients with FEV(1) < 80%. Inhaled corticosteroids should be added in patients with FEV(1) < 50% predicted and frequent exacerbations. To investigate whether pulmonologists follow the GOLD guidelines when prescribing treatment for COPD. A multicenter, cross-sectional, observational study was carried out in 49 Pulmonary Units evenly distributed throughout the country. For each patient the demographic, clinical data and the current therapies were registered in an electronic database. 4094 patients (mean age: 70.9 ± 9.4; males 72.4%, female 27.6%) were enrolled. Disease severity was classified as: mild (745), moderate (1722), severe (923), very severe (704). Irrespective of disease severity, inhaled corticosteroids alone or in combination with long-acting bronchodilators were used in 15.2% and 66.8% of patients, respectively. The appropriateness of the pharmacological treatment of the COPD patients was defined in accordance with the GOLD recommendations. The treatment was appropriate in 37.9% of patients and inappropriate in 62.1%, p < 0.0001. The inappropriateness was due to under-prescription in 7.2% and to over-prescription in 54.9% of patients. The presence and the number of exacerbations represented an important trigger for over-prescription at stages I and II. This study shows that there is a poor relationship between the recommendations of the GOLD international guidelines and current clinical practice, and that exacerbations may play a role in over-prescription. Copyright © 2012 Elsevier Ltd. All rights reserved.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2018
                15 August 2018
                : 13
                : 2455-2462
                Affiliations
                [1 ]Department of Medical and Surgical Sciences, Institute of Respiratory Diseases, University of Foggia, Foggia, Italy, antoniopalmiotti@ 123456hotmail.it
                [2 ]Department of Cardiac, Thoracic, and Vascular Science, Institute of Respiratory Diseases, School of Medicine, University of Bari, Bari, Italy
                [3 ]Physiopathology Respiratory Unit, F Miulli General Hospital, Acquaviva delle Fonti, Bari, Italy
                [4 ]Pneumology Clinic, Vito Fazzi Hospital, Lecce, Italy
                [5 ]UOC of Pneumology, “N Melli” Hospital, San Pietro Vernotico, Italy
                [6 ]Division of Pulmonary Disease, Medical Center of Rehabilitation, Foundation Salvatore Maugeri, IRCCS, Marina di Ginosa, Italy
                [7 ]Department of Respiratory Diseases, San Camillo Clinic, Taranto, Italy
                [8 ]Division of Pulmonary Disease, Medical Center of Rehabilitation, Foundation Salvatore Maugeri, IRCCS, Cassano delle Murge, Italy
                [9 ]UOC of Pneumology, Hospital “Madonna delle Grazie”, Matera, Italy
                [10 ]Regional Health Agency (ARES), Bari, Italy
                Author notes
                Correspondence: Giuseppe Antonio Palmiotti, Institute of Respiratory Diseases, Department of Medical and Surgical Sciences, University of Foggia, viale deglia viatori 71122, Foggia, Italy, Tel +39 0881 733 140, Fax +39 0881 733 040, Email antoniopalmiotti@ 123456hotmail.it
                Article
                copd-13-2455
                10.2147/COPD.S157779
                6101739
                © 2018 Palmiotti et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Original Research

                Respiratory medicine

                online survey, copd, health care spending, web platform, appropriateness

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