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M O N D A Y 839 Daily Symptom Diaries Versus Retrospective Symptom Questionnaires in Clinical Trials: Is This Burden Worth The Effort? A. Y. Okupa, C. A. Sorkness, D. T. Mauger, D. J. Jackson, R. F. Lemanske; University of Wisconsin, Madison, WI, Penn State University College of Medicine, Hershey, PA. RATIONALE: Diary data are burdensome to gather, often incomplete, susceptible to backfilling or data fabrication and therefore, are of questionable reliability. However, there is also concern that questionnaires administered during study encounters (based on retrospective assessments over the previous 1-4 weeks or more) may be subject to incomplete recall and recall bias. Presently, there is insufficient information to compare the value of daily symptom diaries versus retrospective symptom questionnaires for asthma clinical trials. METHODS: 182 children (6-17 years of age) who had uncontrolled asthma were enrolled into the Best Add-on Therapy Giving Effective Responses (BADGER) trial. Asthma control was assessed first, by asthma control days (ACDs) determined by manually recorded daily diary symptom and rescue medication use scores; and second, by monthly retrospective assessments using the age-appropriate version of the Asthma Control Test (ACT). Correlations between ACDs and ACT scores were analyzed, and the sensitivity of each method for measuring asthma control and determining differential response among the three treatments was evaluated. RESULTS: ACT scores correlated better with daily diary information from the previous two weeks (r50.4) than the previous four weeks (r50.3), which is the validated ACT recall period. In addition, significant differential treatment responses were detected using ACD but not ACT scores. CONCLUSIONS: Daily symptom diaries are a more sensitive tool than ACT for assessing differential treatment responses with respect to asthma control. In the BADGER trial, differential treatment response would not have been ascertainable using the ACT tool alone. Using this protocol design, the burden was clearly worth the effort. |
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