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      International Journal of COPD (submit here)

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      Critical Error Frequency and the Impact of Training with Inhalers Commonly used for Maintenance Treatment in Chronic Obstructive Pulmonary Disease

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          Abstract

          Introduction

          Training in correct inhaler use, ideally in person or by video demonstration, can minimize errors but is rarely provided in clinics. This open-label, low-intervention study evaluated critical error rates with dry-powder inhalers (DPIs), before and after training, in patients with chronic obstructive pulmonary disease.

          Methods

          Patients prescribed an inhaled corticosteroid (ICS)/long-acting β 2-agonist (LABA) (ELLIPTA, Turbuhaler, or DISKUS), long-acting muscarinic antagonist (LAMA)/LABA (ELLIPTA or Breezhaler), or LAMA-only DPI (ELLIPTA, HandiHaler, or Breezhaler) were enrolled. Critical errors were assessed before training (Visit 1 [V1]; primary endpoint) and 6 weeks thereafter (Visit 2 [V2]; secondary endpoint). Logistic regression models were used to calculate odds ratios (ORs) for between-group comparisons.

          Results

          The intent-to-treat population comprised 450 patients. At V1, fewer patients made ≥1 critical error with ELLIPTA (10%) versus other ICS/LABA DPIs (Turbuhaler: 40%, OR 4.66, P=0.005; DISKUS: 26%, OR 2.48, P=0.114) and other LAMA or LAMA/LABA DPIs (HandiHaler: 34%, OR 3.50, P=0.026; Breezhaler: 33%, OR 3.94, P=0.012). Critical error rates with the primary ICS/LABA DPI were not significantly different between ELLIPTA ICS/LABA (10%) and ICS/LABA plus LAMA groups (12–25%). Critical errors with the primary ICS/LABA DPI occurred less frequently with ELLIPTA ICS/LABA with or without LAMA (11%) versus Turbuhaler ICS/LABA with or without LAMA (39%, OR 3.99, P<0.001) and DISKUS ICS/LABA with or without LAMA (26%, OR 2.18, P=0.069). Simulating single-inhaler versus multiple-inhaler triple therapy, critical error rates were lower with ELLIPTA fluticasone furoate/vilanterol (FF/VI; 10%) versus ELLIPTA FF/VI plus LAMA (22%), considering errors with either DPI (OR 2.50, P=0.108). At V2, critical error rates decreased for all DPIs/groups, reaching zero only for ELLIPTA. Between-group comparisons were similar to V1.

          Conclusion

          Fewer patients made critical errors with ELLIPTA versus other ICS/LABA, and LAMA or LAMA/LABA DPIs. The effect of “verbal” training highlights its importance for reducing critical errors with common DPIs.

          Most cited references18

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          Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD.

          Incorrect usage of inhaler devices might have a major influence on the clinical effectiveness of the delivered drug. This issue is poorly addressed in management guidelines. This article presents the results of a systematic literature review of studies evaluating incorrect use of established dry powder inhalers (DPIs) by patients with asthma or chronic obstructive pulmonary disease (COPD). Overall, we found that between 4% and 94% of patients, depending on the type of inhaler and method of assessment, do not use their inhalers correctly. The most common errors made included failure to exhale before actuation, failure to breath-hold after inhalation, incorrect positioning of the inhaler, incorrect rotation sequence, and failure to execute a forceful and deep inhalation. Inefficient DPI technique may lead to insufficient drug delivery and hence to insufficient lung deposition. As many as 25% of patients have never received verbal inhaler technique instruction, and for those that do, the quality and duration of instruction is not adequate and not reinforced by follow-up checks. This review demonstrates that incorrect DPI technique with established DPIs is common among patients with asthma and COPD, and suggests that poor inhalation technique has detrimental consequences for clinical efficacy. Regular assessment and reinforcement of correct inhalation technique are considered by health professionals and caregivers to be an essential component of successful asthma management. Improvement of asthma and COPD management could be achieved by new DPIs that are easy to use correctly and are forgiving of poor inhalation technique, thus ensuring more successful drug delivery.
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            Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes

            Background Inhaled drug delivery is the cornerstone treatment for asthma and chronic obstructive pulmonary disease (COPD). However, use of inhaler devices can be challenging, potentially leading to critical errors in handling that can significantly reduce drug delivery to the lungs and effectiveness of treatment. Methods A systematic review was conducted to define ‘critical’ errors and their impact on health outcomes and resource use between 2004 and 2016, using key search terms for inhaler errors in asthma and COPD (Search-1) and associated health-economic and patient burden (Search-2). Results Search-1 identified 62 manuscripts, 47 abstracts, and 5 conference proceedings (n = 114 total). Search-2 identified 9 studies. We observed 299 descriptions of critical error. Age, education status, previous inhaler instruction, comorbidities and socioeconomic status were associated with worse handling error frequency. A significant association was found between inhaler errors and poor disease outcomes (exacerbations), and greater health-economic burden. Conclusions We have shown wide variations in how critical errors are defined, and the evidence shows an important association between inhaler errors and worsened health outcomes. Given the negative impact diminished disease outcomes impose on resource use, our findings highlight the importance of achieving optimal inhaler technique, and a need for a consensus on defining critical and non-critical errors. Electronic supplementary material The online version of this article (10.1186/s12931-017-0710-y) contains supplementary material, which is available to authorized users.
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              Inhaler Errors in the CRITIKAL Study: Type, Frequency, and Association with Asthma Outcomes.

              Poor inhaler technique has been linked to poor asthma outcomes. Training can reduce the number of inhaler errors, but it is unknown which errors have the greatest impact on asthma outcomes.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                COPD
                copd
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove
                1176-9106
                1178-2005
                09 June 2020
                2020
                : 15
                : 1301-1313
                Affiliations
                [1 ]William Harvey Research Institute, Barts & The London School of Medicine & Dentistry, Queen Mary University of London , London, UK
                [2 ]Wolfson Institute of Preventive Medicine, Barts & The London School of Medicine & Dentistry, Queen Mary University of London , London, UK
                [3 ]Department of Pulmonary Diseases, Catharina Hospital , Eindhoven, Netherlands
                [4 ]Department of Pulmonology, Medisch Spectrum Twente , Enschede, Netherlands
                [5 ]Department of Research Methodology, Measurement, and Data Analysis, University of Twente , Enschede, Netherlands
                [6 ]Respiratory Therapy Area Unit, GlaxoSmithKline Plc., Stockley Park , Uxbridge, UK
                [7 ]Respiratory Medical Franchise, GlaxoSmithKline Plc., Research Triangle Park , Durham, NC, USA
                Author notes
                Correspondence: David J Collier William Harvey Research Institute Clinical Research Centre, Barts & The London School of Medicine & Dentistry, Queen Mary University of London , Charterhouse Square, LondonEC1M 6BQ, UK Tel +44 7961 383925 Fax +44 207 253 1901 Email d.j.collier@qmul.ac.uk
                Author information
                http://orcid.org/0000-0003-0866-4058
                http://orcid.org/0000-0003-1071-6769
                http://orcid.org/0000-0003-4723-8123
                http://orcid.org/0000-0003-2434-1152
                http://orcid.org/0000-0001-6315-0450
                http://orcid.org/0000-0002-2239-2020
                http://orcid.org/0000-0001-7981-5197
                Article
                224209
                10.2147/COPD.S224209
                7294437
                32606640
                c18e61fa-13ed-401a-a226-e1062f9b2827
                © 2020 Collier 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
                : 23 July 2019
                : 21 April 2020
                Page count
                Figures: 2, Tables: 4, References: 21, Pages: 13
                Funding
                This study was funded by GlaxoSmithKline plc. (ClinicalTrials.gov number NCT02982187; GlaxoSmithKline plc. study 204981).
                Categories
                Original Research

                Respiratory medicine
                inhaler technique,critical errors,ellipta,inhaled corticosteroid,long-acting β2-agonist,long-acting muscarinic antagonist

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