Measurement characteristics of two asthma symptom diary scales for use in clinical trials

Abstract

The measurement characteristics of two asthma symptom diary scales developed for use as health outcome measures in clinical trials of asthma therapy were investigated. A daytime diary scale was designed to capture the frequency and inconvenience of daytime asthma symptoms and their effects on activities, and a nocturnal asthma symptom diary scale was designed to capture awakenings with asthma symptoms. The internal consistency, reliability, validity and responsiveness of both asthma diary scales were assessed in 346 adult asthma patients in two placebo-controlled clinical trials of an investigational asthma therapy, a leukotriene biosynthesis inhibitor. The daytime symptom scale showed sufficient internal consistency (0.90-0.92), and the daytime and nocturnal symptom scales showed sufficient test retest reliability (0.69-0.87). Construct validity was demonstrated by generally moderate-to-strong correlations for changes in the diary scales with changes in other measures of asthma status, such as forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), and puffs of beta-agonist inhaler. Both scales demonstrated significant responsiveness to change in asthma due to therapy in one of the clinical trials. Based on these results, the daytime and nocturnal asthma symptom diary scales show measurement characteristics appropriate for use as asthma outcome measures in clinical trials of asthma therapy.

Development and validation of an electronic daily control score for asthma (e-DASTHMA): a real-world direct patient data study

“…1 Several questionnaires assess the control of asthma for a period of 1-4 weeks (eg, ACT, ACQ, or CARAT 6 ). e-DASTHMA (similar to patient symptom diaries) 7,21 assesses the period of a single day, but has the advantage of combining asthma symptoms and medication use. As an analogy, e-DASTHMA might represent the equivalent of glycemia in the control of diabetes (with the advantage of taking treatment into consideration), whereas the scores of questionnaires such as ACQ, ACT, and CARAT are analogous to HbA1c.…”

“…However, daily control tests are not available (only symptom diaries). 7 A validated daily control score for asthma is therefore needed, allowing short-term uctuations to be captured and subsequently improving disease monitoring and shared management. Such a biomarker, particularly if mobile health (mHealth)-based, would enable patients and physicians to rapidly analyse results and have timely alerts for uncontrolled disease.…”

Sublingual versus Subcutaneous Immunotherapy for Egyptian Asthmatic Children: Efficacy, Safety and Cost-Effectiveness Study

“…The card items were extracted from. Santanello, et al (23) Patients were asked for daily record of their symptoms and rescue medication use during the baseline period and for 2 weeks before each visit. Nocturnal and diurnal asthma symptoms were recorded on a four-point scale.…”