Back to Journals » International Journal of Chronic Obstructive Pulmonary Disease » Volume 10 » Issue 1

Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study

Authors Kulich K, Keininger DL, Tiplady B, Banerji D

Received 22 August 2014

Accepted for publication 5 November 2014

Published 7 January 2015 Volume 2015:10(1) Pages 79—94

DOI https://doi.org/10.2147/COPD.S73092

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Dr Richard Russell

Károly Kulich,1 Dorothy L Keininger,1 Brian Tiplady,2 Donald Banerji3

1Novartis Pharma AG, Basel, Switzerland; 2eResearch Technologies Ltd, Peterborough, UK; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

Background: Symptoms, particularly dyspnea, and activity limitation, have an impact on the health status and the ability to function normally in patients with chronic obstructive pulmonary disease (COPD).
Methods: To develop an electronic patient diary (eDiary), qualitative patient interviews were conducted from 2009 to 2010 to identify relevant symptoms and degree of bother due to symptoms. The eDiary was completed by a subset of 209 patients with moderate-to-severe COPD in the 26-week QVA149 SHINE study. Two morning assessments (since awakening and since the last assessment) and one evening assessment were made each day. Assessments covered five symptoms (“shortness of breath,” “phlegm/mucus,” “chest tightness,” “wheezing,” and “coughing”) and two impact items (“bothered by COPD” and “difficulty with activities”) and were scored on a 10-point numeric scale.
Results: Patient compliance with the eDiary was 90.4% at baseline and 81.3% at week 26. Correlations between shortness of breath and impact items were >0.95. Regression analysis showed that shortness of breath was a highly significant (P<0.0001) predictor of impact items. Exploratory factor analysis gave a single factor comprising all eDiary items, including both symptoms and impact items. Shortness of breath, the total score (including five symptoms and two impact items), and the five-item symptom score from the eDiary performed well, with good consistency and reliability. The eDiary showed good sensitivity to change, with a 0.6 points reduction in the symptoms scores (on a 0–10 point scale) representing a meaningful change.
Conclusion: The eDiary was found to be valid, reliable, and responsive. The high correlations obtained between “shortness of breath” and the ratings of “bother” and “difficulty with activities” confirmed the relevance of this symptom in patients with COPD. Future studies will be required to explore further psychometric properties and their ability to differentiate between COPD treatments.

Keywords: QVA149, psychometric assessment, dyspnea, health status, patient-reported outcomes

Creative Commons License 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. 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.

Download Article [PDF]  View Full Text [HTML][Machine readable]

 

Readers of this article also read:

Relationship between linear and nonlinear dynamics of heart rate and impairment of lung function in COPD patients

Mazzuco A, Medeiros WM, Sperling MP, Souza AS, Alencar MC, Arbex FF, Neder JA, Arena R, Borghi-Silva A

International Journal of Chronic Obstructive Pulmonary Disease 2015, 10:1651-1661

Published Date: 17 August 2015

Assessment of the risk of falling with the use of timed up and go test in the elderly with lower extremity osteoarthritis

Zasadzka E, Borowicz AM, Roszak M, Pawlaczyk M

Clinical Interventions in Aging 2015, 10:1289-1298

Published Date: 7 August 2015

Caregivers’ burden in patients with COPD

Miravitlles M, Peña-Longobardo LM, Oliva-Moreno J, Hidalgo-Vega Á

International Journal of Chronic Obstructive Pulmonary Disease 2015, 10:347-356

Published Date: 12 February 2015

Tiotropium HandiHaler® and Respimat® in COPD: a pooled safety analysis

Halpin DMG, Dahl R, Hallmann C, Mueller A, Tashkin D

International Journal of Chronic Obstructive Pulmonary Disease 2015, 10:239-259

Published Date: 5 February 2015

Reversal of corticosteroid insensitivity by p38 MAPK inhibition in peripheral blood mononuclear cells from COPD

Khorasani N, Baker J, Johnson M, Chung KF, Bhavsar PK

International Journal of Chronic Obstructive Pulmonary Disease 2015, 10:283-291

Published Date: 4 February 2015

Systemic and pulmonary inflammation is independent of skeletal muscle changes in patients with chronic obstructive pulmonary disease

Barker BL, McKenna S, Mistry V, Pancholi M, Patel H, Haldar K, Barer MR, Pavord ID, Steiner MC, Brightling CE, Bafadhel M

International Journal of Chronic Obstructive Pulmonary Disease 2014, 9:975-981

Published Date: 15 September 2014

The burden of unintended pregnancies in Brazil: a social and public health system cost analysis

Le HH, Connolly MP, Bahamondes L, Cecatti JG, Yu J, Hu HX

International Journal of Women's Health 2014, 6:663-670

Published Date: 16 July 2014