Pediatric asthma assessment: validation of 2 symptom diaries

N C Santanello1

  • 1Merck Research Laboratories, West Point, PA 19486, USA.

Insights

Pediatric asthma diaries, the Pediatric Asthma Diary (PAD) and Pediatric Asthma Caregiver Diary (PACD), offer a reliable method for assessing asthma intervention effectiveness in children. These validated tools supplement or replace traditional pulmonary function tests in clinical trials.

Area of Science:

  • Pediatric Pulmonology
  • Clinical Trial Methodology
  • Asthma Research

Background:

  • Assessing pediatric asthma interventions is crucial for improving treatment.
  • Traditional pulmonary function tests are often impractical for young children in multisite studies.
  • Validated diary questionnaires can offer valuable data on intervention efficacy.

Purpose of the Study:

  • To evaluate the validity of two pediatric asthma diary questionnaires: the Pediatric Asthma Diary (PAD) and the Pediatric Asthma Caregiver Diary (PACD).
  • To determine if these diaries are suitable for assessing asthma symptoms and intervention effectiveness in children aged 2-14 years.
  • To compare the utility of diary questionnaires with conventional pulmonary function measures.

Main Methods:

  • Two prospective studies were conducted to assess the validity of the PAD (children 6-14 years) and PACD (children 2-5 years).
  • Children were categorized into stable and unstable asthma groups based on medication requirements.
  • Discriminant validity, construct validity, and responsiveness to therapy changes were evaluated for both diaries.

Main Results:

  • Both the PAD and PACD demonstrated significant discriminant validity, construct validity, and responsiveness to asthma therapy changes.
  • The PACD specifically identified differences in nighttime asthma symptoms, including asthma-related awakenings, between stable and unstable groups.
  • Diary questionnaires proved valuable for evaluating interventions when pulmonary function testing is not feasible.

Conclusions:

  • The Pediatric Asthma Diary (PAD) and Pediatric Asthma Caregiver Diary (PACD) are valid tools for assessing asthma symptoms in children.
  • These diaries can serve as a reliable alternative or adjunct to pulmonary function testing in pediatric asthma clinical trials.
  • Validated questionnaires enhance the evaluation of asthma interventions in pediatric populations, especially in challenging study settings.

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