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      Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes

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          Abstract

          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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          Most cited references155

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          The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration

          Systematic reviews and meta-analyses are essential to summarise evidence relating to efficacy and safety of healthcare interventions accurately and reliably. The clarity and transparency of these reports, however, are not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (quality of reporting of meta-analysis) statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realising these issues, an international group that included experienced authors and methodologists developed PRISMA (preferred reporting items for systematic reviews and meta-analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this explanation and elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA statement, this document, and the associated website (www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.
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            Development and validation of a questionnaire to measure asthma control

            International guidelines on asthma management indicate that the primary goal of treatment should be optimum asthma control. The aim of this study was to develop and validate the Asthma Control Questionnaire (ACQ). The authors generated a list of all symptoms used to assess control and sent it to 100 asthma clinicians who were members of guidelines committees (18 countries). They scored each symptom for its importance in evaluating asthma control. From the 91 responses, the five highest scoring symptoms were selected for the ACQ. In addition, there is one question on beta2-agonist use and another on airway calibre (total questions=7). The ACQ was tested in a 9-week observational study of 50 adults with symptomatic asthma. The ACQ and other measures of asthma health status were assessed at baseline, 1, 5 and 9 weeks. In patients whose asthma was stable between clinic visits, reliability of the ACQ was high (intraclass correlation coefficient (ICC)=0.90). The questionnaire was very responsive to change in asthma control (p<0.0001). Cross-sectional and longitudinal validity were supported by correlations between the ACQ and other measures of asthma health status being close to a priori predictions. In conclusion, the Asthma Control Questionnaire has strong evaluative and discriminative properties and can be used with confidence to measure asthma control.
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              Development of the asthma control test: a survey for assessing asthma control.

              Asthma guidelines indicate that the goal of treatment should be optimum asthma control. In a busy clinic practice with limited time and resources, there is need for a simple method for assessing asthma control with or without lung function testing. The objective of this article was to describe the development of the Asthma Control Test (ACT), a patient-based tool for identifying patients with poorly controlled asthma. A 22-item survey was administered to 471 patients with asthma in the offices of asthma specialists. The specialist's rating of asthma control after spirometry was also collected. Stepwise regression methods were used to select a subset of items that showed the greatest discriminant validity in relation to the specialist's rating of asthma control. Internal consistency reliability was computed, and discriminant validity tests were conducted for ACT scale scores. The performance of ACT was investigated by using logistic regression methods and receiver operating characteristic analyses. Five items were selected from regression analyses. The internal consistency reliability of the 5-item ACT scale was 0.84. ACT scale scores discriminated between groups of patients differing in the specialist's rating of asthma control (F = 34.5, P <.00001), the need for change in patient's therapy (F = 40.3, P <.00001), and percent predicted FEV(1) (F = 4.3, P =.0052). As a screening tool, the overall agreement between ACT and the specialist's rating ranged from 71% to 78% depending on the cut points used, and the area under the receiver operating characteristic curve was 0.77. Results reinforce the usefulness of a brief, easy to administer, patient-based index of asthma control.
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                Author and article information

                Contributors
                +44 (0)20 7351 8051 , o.usmani@imperial.ac.uk
                federico.lavorini@unifi.it
                jonathan.marshall@mundipharma.com
                will.dunlop@mundipharma.com
                louise.heron@adelphivalues.com
                emily.farrington@adelphivalues.com
                richard.dekhuijzen@radboudumc.nl
                Journal
                Respir Res
                Respir. Res
                Respiratory Research
                BioMed Central (London )
                1465-9921
                1465-993X
                16 January 2018
                16 January 2018
                2018
                : 19
                : 10
                Affiliations
                [1 ]ISNI 0000 0001 2113 8111, GRID grid.7445.2, Airway Disease, , NHLI, Imperial College London & Royal Brompton Hospital, ; Dovehouse Street, London, SW3 6LY UK
                [2 ]ISNI 0000 0004 1759 9494, GRID grid.24704.35, Department of Experimental and Clinical Medicine, , Careggi University Hospital, ; Florence, Italy
                [3 ]Mundipharma International Limited, Cambridge Science Park, Cambridge, CB4 0AB UK
                [4 ]Adelphi Values, Adelphi Mill, Macclesfield, Cheshire, SK10 5JB UK
                [5 ]ISNI 0000 0004 0444 9382, GRID grid.10417.33, Radboud University Medical Center, ; Nijmegen, Netherlands
                Article
                710
                10.1186/s12931-017-0710-y
                5771074
                29338792
                2fdace6b-da92-4a75-9003-0d5075490093
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 7 September 2017
                : 21 December 2017
                Funding
                Funded by: Mundipharma International Ltd
                Award ID: n/a
                Categories
                Review
                Custom metadata
                © The Author(s) 2018

                Respiratory medicine
                obstructive lung diseases,adherence,errors,aerosols,inhalers
                Respiratory medicine
                obstructive lung diseases, adherence, errors, aerosols, inhalers

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