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Free Content Development and validation of an onset of effect questionnaire for patients with asthma

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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 [FEV1; p < 0.0001 and symptom severity] p < 0.001) and predictive validity (response after 1 week of treatment predicted 2-week 15-minute postdose FEV1 [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.

Keywords: Adherence; asthma; bronchodilation; compliance; health outcomes; instrument development; maintenance therapy; noncompliance; qualitative methods; self-management; validity

Document Type: Research Article


Affiliations: United BioSource Corporation, Bethesda, Maryland, USA.

Publication date: November 1, 2008

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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