Table 2.
Exacerbation Outcomes | Definition |
---|---|
Self-reported | An event reported by the subject during monthly telephone calls with the study coordinator. Changes in medications such as inhaled bronchodilators, antibiotics, or systemic corticosteroids, office visits, emergency department visits, and hospitalizations. |
Anthonisen criteria (A1) | An increase over two consecutive days in three out of three symptoms (dyspnea, sputum volume and sputum purulence) as captured by CLEAR-Sx using the 7-day rolling average as the threshold (Anthonisen Class 1). |
Anthonisen criteria (A2) | An increase over two consecutive days in at least two out of three symptoms (dyspnea, sputum volume and sputum purulence) as captured by CLEAR-Sx using the 7-day rolling average as the threshold (Anthonisen Class 2) |
Modified Anthonisen criteria (MA) | An increased over two consecutive days of two major symptoms (breathlessness, sputum volume and sputum purulence) or increased one major symptom plus one minor symptom (cough or wheezing) as captured by CLEAR-Sx using the 7-day rolling average as the threshold (Modified Anthonisen Criteria). |
Use of antibiotic | Self-reported use of any antibiotic for worsening respiratory symptoms from responses to the CLEAR-Sx. |
Use of systemic corticosteroid | Self-reported use of systemic corticosteroid such as prednisone for worsening respiratory symptoms from responses to the CLEAR-Sx. |
Abbreviations: CLEAR-Sx, symptom reporting; SD, standard deviation.