title: Development and validation of an onset of effect questionnaire for patients with asthma.
abstract: A maintenance medication that patients with asthma can feel working shortly after administration could reinforce daily treatment and improve satisfaction, adherence, and outcomes. This study was performed to develop and test a measure assessing patient perception and satisfaction with feeling an asthma medication working right away. Three studies were conducted to develop and evaluate the measure. Study 1 involved qualitative patient interviews to understand the concept of feeling a medication working right away and developed the assessment method and item pool (n = 64). Study 2 examined item clarity and content validity through cognitive interviews (n = 39). Study 3 tested reliability and validity through secondary analyses of data from adults participating in a 12-week, multicenter, double-blind, placebo-controlled phase III trial of mild to moderate persistent asthma (n = 245). A five-item weekly diary, the Onset of Effect Questionnaire, was developed with two items selected as primary: one evaluating whether patients feel their medication working right away and one assessing satisfaction with how quickly they feel their medication begin to work. These items showed 1-week reproducibility (phi = 0.77; 0.70; p < 0.0001), construct validity (relationship with improvement in 15-minute postdose forced expiratory volume in 1 second [FEV(1); p < 0.0001 and symptom severity] p < 0.001) and predictive validity (response after 1 week of treatment predicted 2-week 15-minute postdose FEV(1) [p < 0.0001], Asthma Quality of Life Questionnaire symptom domain [p < 0.05], and Patient Satisfaction with Asthma Medication overall perception of medication [p < 0.0001] and asthma relief subscales [p < 0.0001]). Results suggest that the items are reliable and valid and may be used as end points in clinical trials involving similar patient populations.
authors.affiliation: United BioSource Corporation, Bethesda, MD 20814, USA. nancy.leidy@unitedbiosource.com
authors.forename: Nancy K
authors.initials: NK
authors.lastname: Leidy
authors.forename: Susan D
authors.initials: SD
authors.lastname: Mathias
authors.forename: Bhash M
authors.initials: BM
authors.lastname: Parasuraman
authors.forename: Donald L
authors.initials: DL
authors.lastname: Patrick
authors.forename: Dev
authors.initials: D
authors.lastname: Pathak
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D016022:Case-Control Studies; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010349:Patient Compliance; D010549:Personal Satisfaction; D011237:Predictive Value of Tests; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents