Clinically meaningful changes in quantitative measures of asthma severity.

Abstract

To determine minimum clinically meaningful improvements in peak expiratory flow rate (PEFR) and dyspnea visual analog score (VAS) in patients with acute asthma exacerbation. Patients presenting to the emergency department (ED) with acute asthma exacerbation were eligible. The PEFR and VAS were assessed at presentation and after initial asthma therapy. During reassessment, subjects were asked to describe their asthma symptoms as "much better," "a little better," "no change," "a little worse," or "much worse." Correspondence between self-reported improvement and changes in PEFR and VAS was assessed. The "minimum clinically significant change" in either index was defined as the difference between pre- and posttreatment measures in subjects reporting their symptoms "a little better." One hundred fifty-six subjects were included. Asthma symptoms were "much better" in 99 (64%), "a little better" in 41 (26%), and "unimproved" (composed of patients describing symptoms as "no change," "a little worse," or "much worse") in 16 (10%). The mean VAS change among the "a little better" subjects was 2.2 cm (95% CI = 1.1 to 3.4), significantly greater than the -0.4 cm (95% CI = -2.1 to 1.4) change in the "unimproved" subjects. The mean change in percent predicted PEFR among the "a little better" subjects was 11.9 (95% CI = 7.3 to 16.1), not statistically different from the change of 6.1 (95% CI = 1.1 to 11.3) in the "no change" subjects. The "much better" group showed significantly greater changes in both measures than either of the other groups. A VAS change of > or =0.5 cm reliably discriminated between subjects with and without symptom improvement. Improvements in VAS of 2.2 cm and in predicted PEFR of about 12 percentage points are minimal clinically significant improvements during ED asthma therapy. The dyspnea VAS is valid in assessing symptomatic changes and may detect small subjective improvements better than the PEFR.