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(Chest. 2003;124:2182-2191.)
© 2003 American College of Chest Physicians

The Breathlessness, Cough, and Sputum Scale*

The Development of Empirically Based Guidelines for Interpretation

Nancy Kline Leidy, PhD; Stephen I. Rennard, MD, FCCP; Jordana Schmier, MA; M. Kathryn C. Jones, MA, MSc and Mitch Goldman, MD, PhD

* From MEDTAP International (Dr. Leidy and Ms. Schmier), Bethesda, MD; University of Nebraska Medical Center (Dr. Rennard), Omaha, NE; and AstraZeneca (Dr. Goldman and Ms. Jones), Wilmington, DE.

Correspondence to: Nancy Kline Leidy, PhD, Center for Health Outcomes Research, MEDTAP International, Inc., 7101 Wisconsin Ave, Suite 600, Bethesda, MD 20814; e-mail: leidy{at}medtap.com

Background: A patient report of respiratory symptoms in COPD is essential to successfully monitoring disease, adjusting treatment, and evaluating outcomes.

Objective: To develop empirically based guidelines for interpreting mean changes in symptom scores using the Breathlessness, Cough, and Sputum Scale (BCSS).

Methods: Analyses were performed on data from three multinational trials (n = 2,971). Mean changes in BCSS score with treatment were examined by physician and patient ratings of treatment efficacy, juxtaposed with percentage change in symptoms, statistical effect size (ES), {Delta}FEV1, and change in St. George Respiratory Questionnaire (SGRQ) score. BCSS scores during an exacerbation were examined relative to changes in peak expiratory flow and rescue medication use.

Results: Mean baseline BCSS total score was 5.2 ± 2 (± SD); 90% of scores were between 2 and 9. Highly efficacious treatment (n = 257; physician rating) was associated with a {Delta}BCSS total score of - 1.3 ± 1.8, representing a 24% improvement (ES = 0.7), and corresponding to a 10% improvement in FEV1 and {Delta}SGRQ score total of - 10.3 ± 13.8. Similar changes in BCSS score were observed during recovery from an exacerbation (n = 713; - 1.3 ± 1.8). Mean change with moderately efficacious treatment (n = 965) was - 0.7 ± 1.8, a 13% improvement (ES = 0.3) corresponding to {Delta}SGRQ total score of - 6.8 ± 12.6. Mildly efficacious treatment (n = 891) was associated with a change of - 0.35, a 7% improvement (ES = 0.18), with a {Delta}FEV1 <1% and {Delta}SGRQ total score of - 2.6 ± 11.7.

Conclusions: Patient-reported daily symptom data are sensitive to change and useful for both observational studies and controlled clinical trials of patients with COPD. A mean {Delta}BCSS total score > 1.0 represents substantial symptomatic improvement, changes of approximately 0.6 can be interpreted as moderate, and changes of 0.3 can be considered small.

Key Words: bronchitis • clinical trials • COPD • cough • dyspnea • emphysema • exacerbation • health-related quality of life • instrument • patient-reported outcome • sputum • St. George Respiratory Questionnaire • symptoms




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