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Validation of an asthma symptom diary for interventional studies
N C Santanello1, G Davies, S P Galant
1Department of Epidemiology, Merck Research Laboratories, PO Box 4, BL-3, West Point, PA 19486, USA.
Archives of Disease in Childhood
|April 20, 1999
Summary
The Pediatric Asthma Diary effectively measures asthma control in children. Its symptom scale and "day without asthma" metrics are valid for assessing treatment effectiveness in pediatric asthma research.
Area of Science:
- Pediatric Pulmonology
- Clinical Trial Design
- Asthma Management
Background:
- Asthma is a prevalent chronic respiratory condition in children.
- Effective interventions require reliable outcome measures.
- The Pediatric Asthma Diary was developed to address this need.
Purpose of the Study:
- To validate the Pediatric Asthma Diary for assessing intervention efficacy in children with asthma.
- To establish the reliability and responsiveness of diary-derived measures.
Main Methods:
- A prospective, three-week study involved 106 children (aged 6-14) with asthma.
- Participants were categorized as stable or new onset/worse asthma at baseline.
- Diary questions were used to define a daytime symptom scale and "day without asthma".
Main Results:
- The daytime symptom scale and "day without asthma" measures showed significant validity and responsiveness.
- Children with new onset/worse asthma had fewer "days without asthma" initially compared to stable children.
- Significant improvement in "days without asthma" was observed in the new onset/worse group post-intervention.
Conclusions:
- The Pediatric Asthma Diary's symptom scale and "day without asthma" are acceptable measures.
- These validated measures are suitable for use in pediatric asthma intervention studies.
- The diary aids in evaluating the effectiveness of asthma treatments in children.
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