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Clinical Investigations: COUGH |

The Breathlessness, Cough, and Sputum Scale*: The Development of Empirically Based Guidelines for Interpretation

Nancy Kline Leidy; Stephen I. Rennard; Jordana Schmier; M. Kathryn C. Jones; Mitch Goldman
Author and Funding Information

*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@medtap.com



Chest. 2003;124(6):2182-2191. doi:10.1378/chest.124.6.2182
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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), ΔFEV1, 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 ΔBCSS total score of − 1.3 ± 1.8, representing a 24% improvement (ES = 0.7), and corresponding to a 10% improvement in FEV1 and ΔSGRQ 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 ΔSGRQ 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 ΔFEV1 <1% and ΔSGRQ 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 ΔBCSS 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.

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