Assessment of the Effect of Pharmacotherapy in Common Cold/Acute Bronchitis – the Bronchitis Severity Scale (BSS)

Abstract

Background: Acute bronchitis (AB) is a highly contagious infection of the airways, presenting mostly in connection with common cold (CC). There is a high variance in duration and course of symptoms which, sooner or later, also may disappear spontaneously and change during the course of the disease. Therefore, assessment of treatment outcome is difficult.

Methods: Composite outcome measures are commonly used to examine the effects of pharmacotherapy in complex diseases. We discuss the features of the Bronchitis Severity Scale (BSS) on the basis of the available literature.

Results: For the BSS the five most important symptoms of AB are rated by the patient and the physician. Since its introduction in 1996, the BSS has been used in many clinical trials evaluating treatment effects of AB. Its score correlates well with clinical findings. As thorough validation analyses revealed, this applies even more to the BSS subscales “cough domain” and “sputum domain”.

Conclusion: The validated BSS appears to be a reliable tool to assess therapeutic effects in CC/AB. The BSS and its subscales are recommended as outcome measures for future drug trials in CC/AB, but also help physicians to focus their consultation in patients with CC/AB.

Zusammenfassung

Hintergrund: Akute Bronchitis (AB) ist eine Entzündung der Atemwege. Sie tritt meist im Rahmen eines Erkältungsinfektes auf (engl. common cold; CC). Die klinische Symptomatik ist in Dauer und Verlauf äußerst variabel, früher oder später spontan abklingend und kann sich im Krankheitsverlauf ändern, was die Beurteilung der Wirksamkeit von Therapiemaßnahmen erschwert.

Methode: Zur Einschätzung von Behandlungsmaßnahmen bei komplexen Krankheiten werden oft zusammengesetzte Ratingskalen eingesetzt. Wir stellen die Bronchitis Severity Scale (BSS) vor und diskutieren sie anhand vorhandener Literatur.

Ergebnisse: Für die BSS werden die 5 wichtigsten Symptome bei AB von Patient und Arzt eingeschätzt. Seit ihrer Einführung 1996 wurde die BSS in vielen klinischen Studien zur Einschätzung von Therapieeffekten bei AB genutzt. Ihre Resultate stimmten stets gut mit der klinischen Situation überein. Die Validierungsanalyse zeigte, dass die BSS-Unterskalen „Hustendomäne“ und „Sputumdomäne“ die klinischen Gegebenheiten noch genauer widerspiegeln.

Schlussfolgerungen: Die validierte BSS und ihre Unterskalen eignen sich zur Einschätzung von Therapieeffekten bei CC/AB. Sie werden als Zielparameter für klinische Studien empfohlen und erleichtern auch Ärzten die Diagnose.

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