Display options
Share it on

Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211049743. doi: 10.1177/17534666211049743.

Validation of a visual analog scale for assessing cough severity in patients with chronic cough.

Therapeutic advances in respiratory disease

Allison Martin Nguyen, Elizabeth D Bacci, Margaret Vernon, Surinder S Birring, Carmen La Rosa, David Muccino, Jonathan Schelfhout

Affiliations

  1. Merck & Co., Inc., Kenilworth, NJ, USA.
  2. Evidera Inc., Bethesda, MD, USA.
  3. Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.
  4. Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.

PMID: 34697975 PMCID: PMC8552382 DOI: 10.1177/17534666211049743

Abstract

INTRODUCTION: Patients with chronic cough experience considerable burden. The cough severity visual analog scale (VAS) records patients' assessment of cough severity on a 100-mm linear scale ranging from "no cough" (0 mm) to "worst cough" (100 mm). Although cough severity scales are widely used in clinical practice and research, their use in patients with refractory or unexplained chronic cough has not been formally validated.

METHODS: This analysis includes data from a phase 2b randomized controlled trial of the P2X3-receptor antagonist gefapixant for treatment of refractory or unexplained chronic cough (NCT02612610). Cough severity VAS scores were assessed at baseline and Weeks 4, 8, and 12. The cough severity VAS was validated using several outcomes, including the Cough Severity Diary (CSD), Leicester Cough Questionnaire (LCQ), patient global impression of change (PGIC) scale, and objective cough frequency. Validation metrics included test-retest reliability, convergent and known-groups validity, responsiveness, and score interpretation (i.e., clinically meaningful change threshold).

RESULTS: The analysis included 253 patients (median age, 61.0 years; females, 76%). Test-retest reliability of the cough severity VAS was moderate (intraclass correlation coefficient, 0.51). The cough severity VAS had acceptable convergent validity with other related measures (Pearson

CONCLUSIONS: The cough severity VAS is a valid and responsive measure. A cough severity VAS reduction of ⩾ 30 mm can discriminate clinically meaningful changes in chronic cough severity in clinical studies.

Keywords: Cough Severity Diary; Leicester Cough Questionnaire; clinically meaningful change; cough monitoring; idiopathic cough; minimal important difference; objective cough frequency; patient-reported outcomes; responder threshold

References

  1. BMC Pulm Med. 2020 Mar 20;20(1):68 - PubMed
  2. Thorax. 2003 Apr;58(4):339-43 - PubMed
  3. Eur Respir J. 2020 Mar 20;55(3): - PubMed
  4. Ther Adv Respir Dis. 2010 Aug;4(4):199-208 - PubMed
  5. Lung. 2019 Oct;197(5):635-639 - PubMed
  6. Chest. 2017 Sep;152(3):547-562 - PubMed
  7. J Thorac Dis. 2014 Oct;6(Suppl 7):S728-34 - PubMed
  8. Chest. 2002 Apr;121(4):1123-31 - PubMed
  9. J Allergy Clin Immunol Pract. 2019 Jul - Aug;7(6):1711-1714 - PubMed
  10. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620915155 - PubMed
  11. Lancet Respir Med. 2020 Aug;8(8):775-785 - PubMed
  12. Ann Emerg Med. 2001 Dec;38(6):639-43 - PubMed
  13. Chest. 2018 Jan;153(1):196-209 - PubMed
  14. Respir Med. 2013 Mar;107(3):408-12 - PubMed
  15. Respir Med. 2001 Dec;95(12):999-1002 - PubMed
  16. J Allergy Clin Immunol Pract. 2019 Jul - Aug;7(6):1715-1723 - PubMed
  17. Eur Respir J. 2015 May;45(5):1479-81 - PubMed
  18. Malawi Med J. 2012 Sep;24(3):69-71 - PubMed
  19. J Chiropr Med. 2016 Jun;15(2):155-63 - PubMed
  20. Lung. 2015 Jun;193(3):401-8 - PubMed
  21. Chest. 2015 Mar;147(3):804-814 - PubMed
  22. Eur Respir J. 2020 Jan 2;55(1): - PubMed
  23. ERJ Open Res. 2020 Apr 19;6(2): - PubMed
  24. BMJ Open. 2017 Jan 16;7(1):e014112 - PubMed
  25. Thorax. 2007 Apr;62(4):329-34 - PubMed
  26. Curr Opin Pharmacol. 2015 Jun;22:37-40 - PubMed
  27. BMJ Open. 2019 Jun 11;9(6):e030945 - PubMed
  28. BMC Pulm Med. 2017 Nov 21;17(1):146 - PubMed
  29. Cough. 2009 Mar 19;5:5 - PubMed
  30. Chest. 2020 Jan;157(1):111-118 - PubMed
  31. Am J Respir Crit Care Med. 2013 May 1;187(9):991-7 - PubMed
  32. Lung. 2020 Feb;198(1):13-21 - PubMed
  33. Chest. 2017 Sep;152(3):563-573 - PubMed
  34. Acad Emerg Med. 2003 Apr;10(4):360-3 - PubMed
  35. Respirology. 2019 Jun;24(6):551-557 - PubMed

Publication Types