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      Clinical Concepts for Triple Therapy Use in Patients with COPD: A Delphi Consensus

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          Abstract

          Purpose

          Role of triple therapy in chronic obstructive pulmonary disease (COPD) management is supported by growing evidence, but consensus is lacking on various aspects. We conducted a Delphi survey in respiratory experts on the effects of triple therapy on exacerbation reduction, early optimization, pneumonia risk, and mortality benefits in COPD management.

          Methods

          The study comprised 2-round online surveys and a participant meeting with 21 respiratory experts from 10 countries. The 31-statement questionnaire was prepared using Decipher software after literature review. Responses were recorded using Likert scale ranging from 1 (disagreement) to 9 (agreement) with a consensus threshold of 75%.

          Results

          All experts participated in both surveys and 14/21 attended participant meeting. Consensus was reached on 13/31 questions in first survey and 4/14 in second survey on: mortality benefits of triple therapy; comparable pneumonia risk between single inhaler triple therapy (SITT) and multiple inhaler triple therapy (81%); preference of SITT for patients with high eosinophil count (95%); exacerbation risk reduction and healthcare cost benefits with early initiation of SITT post exacerbation-related hospitalization (<30 days) (86%). No consensus was reached on first line SITT use after first exacerbation resulting in COPD diagnosis (62%).

          Conclusion

          This study demonstrated that there is consensus among experts regarding many of the key concepts about appropriate clinical use and benefits of triple therapy in COPD. More evidence is required for evaluating the benefits of early optimisation of triple therapy.

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          Most cited references49

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          Susceptibility to exacerbation in chronic obstructive pulmonary disease.

          Although we know that exacerbations are key events in chronic obstructive pulmonary disease (COPD), our understanding of their frequency, determinants, and effects is incomplete. In a large observational cohort, we tested the hypothesis that there is a frequent-exacerbation phenotype of COPD that is independent of disease severity. We analyzed the frequency and associations of exacerbation in 2138 patients enrolled in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study. Exacerbations were defined as events that led a care provider to prescribe antibiotics or corticosteroids (or both) or that led to hospitalization (severe exacerbations). Exacerbation frequency was observed over a period of 3 years. Exacerbations became more frequent (and more severe) as the severity of COPD increased; exacerbation rates in the first year of follow-up were 0.85 per person for patients with stage 2 COPD (with stage defined in accordance with Global Initiative for Chronic Obstructive Lung Disease [GOLD] stages), 1.34 for patients with stage 3, and 2.00 for patients with stage 4. Overall, 22% of patients with stage 2 disease, 33% with stage 3, and 47% with stage 4 had frequent exacerbations (two or more in the first year of follow-up). The single best predictor of exacerbations, across all GOLD stages, was a history of exacerbations. The frequent-exacerbation phenotype appeared to be relatively stable over a period of 3 years and could be predicted on the basis of the patient's recall of previous treated events. In addition to its association with more severe disease and prior exacerbations, the phenotype was independently associated with a history of gastroesophageal reflux or heartburn, poorer quality of life, and elevated white-cell count. Although exacerbations become more frequent and more severe as COPD progresses, the rate at which they occur appears to reflect an independent susceptibility phenotype. This has implications for the targeting of exacerbation-prevention strategies across the spectrum of disease severity. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00292552.)
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            Research guidelines for the Delphi survey technique.

            Consensus methods such as the Delphi survey technique are being employed to help enhance effective decision-making in health and social care. The Delphi survey is a group facilitation technique, which is an iterative multistage process, designed to transform opinion into group consensus. It is a flexible approach, that is used commonly within the health and social sciences, yet little guidance exists to help researchers undertake this method of data collection. This paper aims to provide an understanding of the preparation, action steps and difficulties that are inherent within the Delphi. Used systematically and rigorously, the Delphi can contribute significantly to broadening knowledge within the nursing profession. However, careful thought must be given before using the method; there are key issues surrounding problem identification, researcher skills and data presentation that must be addressed. The paper does not claim to be definitive; it purports to act as a guide for those researchers who wish to exploit the Delphi methodology.
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              Using and Reporting the Delphi Method for Selecting Healthcare Quality Indicators: A Systematic Review

              Objective Delphi technique is a structured process commonly used to developed healthcare quality indicators, but there is a little recommendation for researchers who wish to use it. This study aimed 1) to describe reporting of the Delphi method to develop quality indicators, 2) to discuss specific methodological skills for quality indicators selection 3) to give guidance about this practice. Methodology and Main Finding Three electronic data bases were searched over a 30 years period (1978–2009). All articles that used the Delphi method to select quality indicators were identified. A standardized data extraction form was developed. Four domains (questionnaire preparation, expert panel, progress of the survey and Delphi results) were assessed. Of 80 included studies, quality of reporting varied significantly between items (9% for year's number of experience of the experts to 98% for the type of Delphi used). Reporting of methodological aspects needed to evaluate the reliability of the survey was insufficient: only 39% (31/80) of studies reported response rates for all rounds, 60% (48/80) that feedback was given between rounds, 77% (62/80) the method used to achieve consensus and 57% (48/80) listed quality indicators selected at the end of the survey. A modified Delphi procedure was used in 49/78 (63%) with a physical meeting of the panel members, usually between Delphi rounds. Median number of panel members was 17(Q1:11; Q3:31). In 40/70 (57%) studies, the panel included multiple stakeholders, who were healthcare professionals in 95% (38/40) of cases. Among 75 studies describing criteria to select quality indicators, 28 (37%) used validity and 17(23%) feasibility. Conclusion The use and reporting of the Delphi method for quality indicators selection need to be improved. We provide some guidance to the investigators to improve the using and reporting of the method in future surveys.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                copd
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove
                1176-9106
                1178-2005
                28 August 2023
                2023
                : 18
                : 1853-1866
                Affiliations
                [1 ]Pneumology Department, Hospital Universitari Vall d’Hebron/Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus; CIBER de Enfermedades Respiratorias (CIBERES) , Barcelona, Spain
                [2 ]Emerging Markets, GlaxoSmithKline , Singapore
                [3 ]Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo , Sao Paulo, SP, Brazil
                [4 ]Internal Medicine and Critical Care Center Departments, Clínica Las Condes and School of Medicine, Universidad Finis Terrae , Santiago, Chile
                [5 ]Respiratory Division, Escola Paulista de Medicina, Federal University of São Paulo , Sao Paulo, Brazil
                [6 ]Division of Respiratory and Respiratory Critical Care Medicine, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University , Songkhla, Thailand
                [7 ]Emerging Markets, GlaxoSmithKline , Panama City, Panama
                [8 ]Pneumonology University Center, School of Medicine, University of Buenos Aires, Argentina, Unit of Pneumonology Hospital “Dr.J.M. Ramos Mejia” , Buenos Aires, Argentina
                Author notes
                Correspondence: Marc Miravitlles, Pneumology Department, Hospital Universitari Vall d’Hebron , Pg. Vall d’Hebron 119-129, Barcelona, 08035, Spain, Tel/Fax +34 932746083, Email marcm@separ.es
                Author information
                http://orcid.org/0000-0002-9850-9520
                http://orcid.org/0000-0002-8370-9319
                http://orcid.org/0000-0002-3057-5716
                http://orcid.org/0000-0002-7178-8187
                http://orcid.org/0000-0001-5995-2856
                Article
                424128
                10.2147/COPD.S424128
                10474219
                37662490
                03f0e8b3-a96e-464d-9739-df58cc4f009b
                © 2023 Miravitlles 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. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 02 June 2023
                : 15 August 2023
                Page count
                Figures: 7, Tables: 1, References: 49, Pages: 14
                Funding
                Funded by: funded by GSK. Meetings, data analysis, and medical writing assistance were funded by GSK;
                This study was funded by GSK. Meetings, data analysis, and medical writing assistance were funded by GSK.
                Categories
                Expert Opinion

                Respiratory medicine
                sitt,mitt,triple inhaled therapy,delphi procedure,copd exacerbations,copd mortality

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