Chest
Volume 124, Issue 6, December 2003, Pages 2182-2191
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Clinical Investigations
COUGH
The Breathlessness, Cough, and Sputum Scale: The Development of Empirically Based Guidelines for Interpretation

https://doi.org/10.1378/chest.124.6.2182Get rights and content

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.

Section snippets

Design

Secondary analyses were performed on available, blinded data from 3,643 patients undergoing treatment during the course of three phase-IIIa, multicenter, multinational, randomized, double-blind, placebo-controlled clinical trials evaluating the safety and efficacy of sibenadet, a novel dual-dopamine D2 receptor/β2 adrenoreceptor agonist developed to treat bronchoconstriction and ameliorate respiratory symptoms in patients with COPD1415; two of the trials involved a 12-week treatment period (n =

Results

Of the 3,643 patients enrolled in the three trials, 2,971 patients were eligible for these secondary analyses based on the existence of data necessary for the analyses outlined above. Within this group, 1,348 patients had an exacerbation during the course of the trial, of whom 713 patients had BCSS data for use in these analyses. Demographic and clinical characteristics of the analytical sample are provided in Table 1. Mean baseline BCSS total score for the sample was 5.18±1.97 on the 12-point

Discussion

The purpose of this study was to develop guidelines for interpreting group-level changes in BCSS scores in clinical studies of COPD. A triangulation method was used, juxtaposing BCSS change scores by clinical indicators of treatment success commonly used in clinical practice and trials involving patients with COPD (physician and patient perception of treatment efficacy, FEV1, and SGRQ scores) along with statistical indicators of magnitude (percentage change and ES). Daily and weekly BCSS scores

BCSS

The BCSS was used in clinical trials as part of a patient's daily diary card. Below is a sample instruction page from the diary card.

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  • Cited by (0)

    This study was supported by AstraZeneca Pharmaceuticals LP.

    Dr. Jones and Dr. Goldman are employees of AstraZeneca.

    Dr. Rennard has received research grant support, honoraria for speaking, and fees for consultancy from AstraZeneca. Neither he nor his family have any ownership position in AstraZeneca.

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