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.
Abstract

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