TY - JOUR T1 - Measurement properties of exacerbations of chronic pulmonary disease tool (EXACT) in a clinical trial of patients with moderate to severe COPD JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P4912 AU - Lindsey Murray AU - Linda Nelsen AU - Heribert Staudinger AU - Kerry Ann Phang AU - Fang Chen AU - Elizabeth Rosenberg AU - Nancy Leidy Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P4912.abstract N2 - Aims: EXACT is a patient reported outcome (PRO) measure designed to evaluate the frequency, severity, and duration of exacerbations in COPD. Performance properties were examined in the context of a clinical trial.Methods: Patients with moderate to severe COPD completed EXACT as a daily electronic diary for 6 months. EXACT score and numbers of exacerbations, medically treated events (MTEs) and symptom-defined (EXACT), were secondary endpoints in a phase 2, randomized, double-blind, placebo-controlled trial. Assessments of EXACT included reliability (internal consistency, reproducibility) and validity (correlation of baseline EXACT score with St. George’s Respiratory Questionnaire–COPD score, FEV1 %Predicted, GOLD stage, and rescue medication use).Results: The intent-to-treat population included 614 subjects (71% male, ages 41-76 years with mean FEV1 %Predicted=47.7). Overall diary compliance was 94%. Score reliability (Cronbach’s alpha) was 0.93; reproducibility (ICC) in stable patients (baseline, Day -7 to Day -1) was 0.82. Validity coefficients were as follows: SGRQ-C (r=0.58), FEV1 %Predicted (r= –0.18), GOLD stage (r=0.16), and rescue medication use (r=0.40) (p<0.0001 for all). For MTE, 173 (28.2%) subjects had ≥1 event, range=1-4, total events=232. For EXACT, 266 (43.3%) subjects had ≥1 event, range=1-5, total events=411. Mean (SD) severity of EXACT events was 52.4 (13.2) points and event duration was 17 days.Conclusions: Results support the reliability and validity of EXACT scores and provide insight into the frequency and severity of reported and unreported events in a clinical trial setting. ER -