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Published on: February 14, 2019
Validation of a pediatric asthma caregiver diary
N C Santanello1, C Demuro-Mercon, G Davies
1Merck Research Laboratories, West Point; the Allergy & Asthma Medical Group and Research Center, San Diego, CA, USA.
Insights
A new pediatric asthma caregiver diary effectively measures symptoms and functioning in young children. The diary highlights a need for better asthma control in children participating in clinical trials.
Area of Science:
- Pediatric Pulmonology
- Clinical Trial Methodology
- Asthma Research
Background:
- Young children struggle with reliable airway function tests, necessitating validated parental reporting tools for asthma intervention studies.
- Current methods lack normative values for pediatric asthma assessment.
Purpose of the Study:
- To develop and validate a pediatric asthma caregiver diary for use in interventional studies.
- To establish reliable measures of asthma symptoms and functioning in preschool-aged children.
Main Methods:
- A 3-week prospective study involved 125 parents and their children (2-5 years) with persistent asthma.
- Children were categorized as stable or unstable based on anti-inflammatory therapy adjustments at baseline.
Main Results:
- A symptom scale and days without asthma symptoms (DWAS) were derived from the diary.
- These measures statistically distinguished between stable and unstable groups and detected changes over time (P <.01).
- The frequency of DWAS was 43% in the stable group and 22% in the unstable group, indicating suboptimal asthma control.
Conclusions:
- The pediatric asthma caregiver diary demonstrates acceptable measurement properties for clinical trials.
- The low frequency of DWAS suggests significant potential for improving asthma control in young children.
Background:
Young children are generally not able to consistently and reliably perform tests of airway function, and normative values are not available. Reliable and valid measures of parental reporting of asthma symptoms and functioning are needed to determine the efficacy of asthma interventions.
Objective:
A pediatric asthma caregiver diary was developed and validated for use in interventional asthma studies.
Methods:
A 3-week prospective study of 125 caregiver parents and their children, aged 2 to 5 years, with persistent asthma was conducted. At baseline, children were classified as either stable (no change to anti-inflammatory therapy) or unstable (anti-inflammatory therapy added or increased).
Results:
A symptom scale and day without asthma symptoms (DWAS) were defined from pediatric asthma caregiver diary questions. The scale and DWAS statistically differentiated between the stable and unstable groups at week 1 and detected change between the 2 groups (P <.01). On average, caregivers reported low symptom scores. However, the frequency of DWAS was only 43% of days in the stable group and 22% in the unstable group.
Conclusion:
The pediatric asthma caregiver diary scale and DWAS have acceptable measurement characteristics for use in clinical trials of children with asthma symptoms. The DWAS indicates an opportunity for improvement in asthma control in this population.
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