Shortness of Breath with Daily Activities questionnaire: validation and responder thresholds in patients with chronic obstructive pulmonary disease

Michael L Watkins, Teresa K Wilcox, Maggie Tabberer, Jean M Brooks, James F Donohue, Antonio Anzueto, Wen-Hung Chen, Courtney Crim, Michael L Watkins, Teresa K Wilcox, Maggie Tabberer, Jean M Brooks, James F Donohue, Antonio Anzueto, Wen-Hung Chen, Courtney Crim

Abstract

Objectives: To test the reliability, validity and responsiveness of the 13-item Shortness of Breath with Daily Activities (SOBDA) questionnaire, and determine the threshold for response and minimal important difference (MID).

Design: 6 week, randomised, double-blind, placebo-controlled study.

Setting: 40 centres in the USA between 29 October 2009 and 1 July 2010.

Primary and secondary outcome measures: 547 patients with chronic obstructive pulmonary disease (COPD) were enrolled and 418 entered the 2-week run-in period. Data from the run-in period were collected to test internal consistency, test-retest reliability, convergent validity and known-groups validity of the SOBDA. Three hundred and sixty six patients were randomised 2:2:1 to fluticasone propionate/salmeterol 250/50 µg, salmeterol 50 µg or placebo, twice daily. Results from the SOBDA questionnaire, Patient Global Assessment of Change Question, modified Medical Research Council Dyspnoea Scale (mMRC), Clinician Global Impression of Dysponea Severity (CGI-S), Clinician Global Impression of Change Question and Chronic Respiratory Disease Questionnaire self-administered standardised version (CRQ-SAS) were evaluated; spirometry and safety parameters were measured. Study endpoints were selected to investigate the cross-sectional and longitudinal validity of the SOBDA questionnaire in relation to the clinical criteria.

Results: Internal consistency of the SOBDA questionnaire (Cronbach α) was 0.89. Test-retest reliability (intraclass correlation) was 0.94. The SOBDA weekly scores correlated with the patient-reported and clinician-reported mMRC, CGI-S and CRQ-SAS dyspnoea domain scores (0.29, 0.24, 0.24 and -0.68, respectively). The SOBDA weekly scores differentiated between the responders and the non-responders as rated by the patients and the clinicians. Anchor-based and supportive distribution-based analyses produced a range of the potential values for the threshold for the responders and MID.

Conclusions: The 13-item SOBDA questionnaire is reliable, valid and responsive to change in patients with COPD. On using anchor-based methods, the proposed responder threshold shows a -0.1 to -0.2 score change. A specific threshold value will be identified as more data are generated from future clinical trials.

Trial registration: NCT00984659; GlaxoSmithKline study number: ASQ112989.

Keywords: RESPIRATORY MEDICINE (see Thoracic Medicine); THORACIC MEDICINE.

Figures

Figure 1
Figure 1
Patient disposition. *Patients who completed visits 1 and 2 including those not randomised. †Patients randomised to treatment and received at least one dose of the study drug. One additional patient was randomised but not treated. BID, twice daily; FSC, fluticasone propionate/salmeterol combination; mITT, modified intent-to-treat; SAL, salmeterol.

References

    1. Rennard S, Decramer M, Calverley PM, et al. Impact of COPD in North America and Europe in 2000: subjects’ perspective of Confronting COPD International Survey. Eur Respir J 2002;20:799–805
    1. Wilcox TK, Chen W-H, Howard KA, et al. Reliability and validity of the Shortness of Breath with Daily Activities (SOBDA) questionnaire: a new outcome measure for evaluating dyspnea in COPD. American Thoracic Society – 106th International Conference. 2010;181:A5429.
    1. Howard K, Berry P, Petrillo J, et al. Development of the Shortness of Breath with Daily Activities questionnaire (SOBDA). Value Health 2012;15:1042–50
    1. Food and Drug Administration. 2009. Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. (accessed 4 Apr 2013)
    1. Celli BR, MacNee W, ATS/ERS Task Force. 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
    1. Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general US population. Am J Respir Crit Care Med 1999;159:179–87
    1. Nunnally JC, Bernstein IH. Psychometric theory. 3rd edn New York: McGraw-Hill, Inc., 1994
    1. Revicki DA, Cella D, Hays RD, et al. Responsiveness and minimal important differences for patient reported outcomes. Health Qual Life Outcomes 2006;4:70.
    1. Wyrwich K, Tierney W, Wolinsky F. Further evidence supporting a SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol 1999;52:861–73
    1. Aaron SD, Vandemheen KL, Clinch JJ, et al. Measurement of short-term changes in dyspnoea and disease-specific quality of life following an acute COPD exacerbation. Chest 2002;121:688–96
    1. Aaron SD, Vandemheen KL, Hebert P, et al. Outpatient oral prednisone after emergency treatment of chronic obstructive pulmonary disease. N Engl J Med 2003;348:2618–25
    1. Parker CM, Voduc N, Aaron SD, et al. Physiological changes during symptom recovery from moderate exacerbations of COPD. Eur Respir J 2005;26:420–8
    1. Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med 1991;85(Suppl. B):2531
    1. Jones PW, Quirk FH, Baveystock CM, et al. 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
    1. Hays R, Anderson R, Revicki DA. Assessing reliability and validity of measurement in clinical trials. In: Staquet MJ, Hays RD, Fayers PM, eds. Quality of life assessment in clinical trials. New York, NY: Oxford University Press, 1998: 167–82
    1. Schunemann HJ, Puhan M, Goldstein R, et al. Measurement properties and interpretability of the chronic respiratory disease questionnaire (CRQ). COPD 2005;2:81–9

Source: PubMed

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