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Respiratory Research
Published in: Respiratory Research 1/2019

Open Access 01-12-2019 | Bronchial Asthma | Research

Reliability, validity and responsiveness of E-RS:COPD in patients with spirometric asthma-COPD overlap

Authors: Linda M. Nelsen, Laurie A. Lee, Wei Wu, Xiwu Lin, Lindsey Murray, Steven J. Pascoe, Nancy K. Leidy

Published in: Respiratory Research | Issue 1/2019

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Abstract

Background

The Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) is a patient-reported diary that assesses respiratory symptoms in stable COPD.

Methods

This post hoc analysis of a randomized, double-blind, parallel-arm trial (GSK ID: 200699; NCT02164539) assessed the structure, reliability, validity and responsiveness of the E-RS, and a separate wheeze item, for use in patients with a primary diagnosis of asthma or COPD, but with spirometric characteristics of both (fixed airflow obstruction and reversibility to salbutamol; a subset of patients referred to as spirometric asthma-COPD overlap [ACO]; N = 338).

Results

Factor analysis demonstrated that E-RS included Cough and Sputum, Chest Symptoms, and Breathlessness domains, with a Total score suitable for quantifying overall respiratory symptoms (comparative fit index: 0.9), consistent with the structure shown in COPD. The wheeze item did not fit the model. Total and domain scores were internally consistent (Cronbach’s alpha: 0.7–0.9) and reproducible (intra-class correlations > 0.7). Moderate correlations between RS-Total and RS-Breathlessness scores were observed with St George’s Respiratory Questionnaire (SGRQ) Total and Activity domain scores at baseline (r = 0.43 and r = 0.48, respectively). E-RS scores were sensitive to change when a patient global impression of change and SGRQ change scores were used to define responders, with changes of ≥ − 1.4 in RS-Total score interpreted as clinically meaningful.

Conclusions

E-RS:COPD scores were reliable, valid and responsive in this sample, suggesting the measure may be suitable for evaluating the severity of respiratory symptoms and the effects of treatment in patients with asthma and COPD that exhibit spirometric characteristics of both fixed airflow obstruction and reversibility. Further study of this instrument and wheeze in new samples of patients with ACO is warranted.
Appendix
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Literature
1.
2.
3.
Gibson PG, Simpson JL. The overlap syndrome of asthma and COPD: what are its features and how important is it? Thorax. 2009;64:728–35.CrossRef
4.
5.
de Marco R, Pesce G, Marcon A, Accordini S, Antonicelli L, Bugiani M, Casali L, Ferrari M, Nicolini G, Panico MG, Pirina P, Zanolin ME, Cerveri I, Verlato G. The coexistence of asthma and chronic obstructive pulmonary disease (COPD): prevalence and risk factors in young, middle-aged and elderly people from the general population. PLoS One. 2013;8:e62985.CrossRef
6.
Gibson PG, McDonald VM. Asthma-COPD overlap 2015: now we are six. Thorax. 2015;70:683–91.CrossRef
7.
Montes de Oca M, Victorina Lopez Varela M, Laucho-Contreras ME, Casas A, Schiavi E, Mora JC. Asthma-COPD overlap syndrome (ACOS) in primary care of four Latin America countries: the PUMA study. BMC Pulm Med. 2017;17:69.CrossRef
8.
Alshabanat A, Zafari Z, Albanyan O, Dairi M, FitzGerald JM. Asthma and COPD overlap syndrome (ACOS): a systematic review and Meta analysis. PLoS One. 2015;10:e0136065.CrossRef
9.
10.
Sin DD, Miravitlles M, Mannino DM, Soriano JB, Price D, Celli BR, Leung JM, Nakano Y, Park HY, Wark PA, Wechsler ME. What is asthma-COPD overlap syndrome? Towards a consensus definition from a round table discussion. Eur Respir J. 2016;48:664–73.CrossRef
11.
Menezes AMB, Montes de Oca M, Perez-Padilla R, Nadeau G, Wehrmeister FC, Lopez-Varela MV, Muino A, Jardim JRB, Valdivia G, Talamo C. Increased risk of exacerbation and hospitalization in subjects with an overlap phenotype: COPD-asthma. Chest. 2014;145:297–304.CrossRef
12.
Nelsen L, Gater A, Panter C, Tolley C, Lee L, Pascoe S. Understanding and measuring symptoms and health status in asthma COPD overlap: content validity of the EXACT and SGRQ. J Patient Rep Outcomes. 2017;2:18.CrossRef
13.
Pascoe SJ, Wu W, Collison KA, Nelsen LM, Wurst KE, Lee LA. Use of clinical characteristics to predict spirometric classification of obstructive lung disease. Int J Chron Obstruct Pulmon Dis. 2018;13:889–902.CrossRef
14.
Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation: The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992;145:1321–7.CrossRef
15.
Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD assessment test. Eur Respir J. 2009;34:648–54.CrossRef
16.
Williams JE, Singh SJ, Sewell L, Guyatt GH, Morgan MD. Development of a self-reported Chronic Respiratory Questionnaire (CRQ-SR). Thorax. 2001;56:954–9.CrossRef
17.
Eakin EG, Sassi-Dambron DE, Ries AL, Kaplan RM. Reliability and validity of dyspnea measures in patients with obstructive lung disease. Int J Behav Med. 1995;2:118–34.CrossRef
18.
Crawford B, Monz B, Hohlfeld J, Roche N, Rubin B, Magnussen H, Nivens C, Ghafouri M, McDonald J, Tetzlaff K. Development and validation of a cough and sputum assessment questionnaire. Respir Med. 2008;102:1545–55.CrossRef
19.
Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014;15:124.CrossRef
20.
Leidy NK, Sexton CC, Jones PW, Notte SM, Monz BU, Nelsen L, Goldman M, Murray LT, Sethi S. Measuring respiratory symptoms in clinical trials of COPD: reliability and validity of a daily diary. Thorax. 2014;69:443–9.CrossRef
21.
Leidy NK, Wilcox TK, Jones PW, Roberts L, Powers JH, Sethi S. Standardizing measurement of chronic obstructive pulmonary disease exacerbations. Reliability and validity of a patient-reported diary. Am J Respir Crit Care Med. 2011;183:323–9.CrossRef
22.
23.
24.
Lee L, Kerwin E, Collison K, Nelsen L, Wu W, Yang S, Pascoe S. The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: a randomised, 3-phase study. Respir Med. 2017;131:148–57.CrossRef
25.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use. ICH harmonised tripartite guideline: guideline for good clinical practice E6(1). 1996.
26.
27.
Celli BR, MacNee W, Force AET. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004;23:932–46.CrossRef
28.
Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
29.
Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J. 2002;19:398–404.CrossRef
30.
Beier J, Mroz R, Kirsten AM, Chuecos F, Gil EG. Improvement in 24-hour bronchodilation and symptom control with aclidinium bromide versus tiotropium and placebo in symptomatic patients with COPD: post hoc analysis of a phase IIIb study. Int J Chron Obstruct Pulmon Dis. 2017;12:1731–40.CrossRef
31.
D'Urzo AD, Rennard SI, Kerwin EM, Mergel V, Leselbaum AR, Caracta CF, AUGMENT COPD study investigators. Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study. Respir Res. 2014;15:123.
32.
Tabberer M, Lomas DA, Birk R, Brealey N, Zhu CQ, Pascoe S, Locantore N, Lipson DA. Once-Daily Triple Therapy in Patients with COPD: Patient-Reported Symptoms and Quality of Life. Adv Ther. 2018;35:56–71.CrossRef
33.
Kerwin E, Donohue JF, Goodin T, Tosiello R, Wheeler A, Ferguson GT. Efficacy and safety of glycopyrrolate/eFlow® CS (nebulized glycopyrrolate) in moderate-to-very-severe COPD: results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 3 and 4 randomized controlled trials. Respir Med. 2017;132:238–50.CrossRef
34.
Papi A, Dokic D, Tzimas W, Meszaros I, Olech-Cudzik A, Koroknai Z, McAulay K, Mersmann S, Dalvi PS, Overend T. Fluticasone propionate/formoterol for COPD management: a randomized controlled trial. Int J Chron Obstruct Pulmon Dis. 2017;12:1961–71.CrossRef
35.
Bae YJ, Kim YS, Park CS, Lee YS, Chang YS, Cho YS, Jang AS, Cho SH, Choi BW, Kim SG, Moon HB, Kim TB. Reliability and validity of the St George's Respiratory Questionnaire for asthma. Int J Tuberc Lung Dis. 2011;15:966–71.CrossRef
36.
Kankaanranta H, Harju T, Kilpelainen M, Mazur W, Lehto JT, Katajisto M, Peisa T, Meinander T, Lehtimaki L. Diagnosis and pharmacotherapy of stable chronic obstructive pulmonary disease: the Finnish guidelines. Basic Clin Pharmacol Toxicol. 2015;116:291–307.CrossRef
37.
Koblizek V, Chlumsky J, Zindr V, Neumannova K, Zatloukal J, Zak J, Sedlak V, Kocianova J, Zatloukal J, Hejduk K, Pracharova S. Chronic Obstructive Pulmonary Disease: official diagnosis and treatment guidelines of the Czech Pneumological and Phthisiological Society; a novel phenotypic approach to COPD with patient-oriented care. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2013;157:189–201.CrossRef
38.
Bateman ED, Reddel HK, van Zyl-Smit RN, Agusti A. The asthma-COPD overlap syndrome: towards a revised taxonomy of chronic airways diseases? Lancet Respir Med. 2015;3:719–28.CrossRef
Metadata
Title
Reliability, validity and responsiveness of E-RS:COPD in patients with spirometric asthma-COPD overlap
Authors
Linda M. Nelsen
Laurie A. Lee
Wei Wu
Xiwu Lin
Lindsey Murray
Steven J. Pascoe
Nancy K. Leidy
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Respiratory Research / Issue 1/2019
Electronic ISSN: 1465-993X
DOI
https://doi.org/10.1186/s12931-019-1070-6

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