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Published on: February 14, 2019
Pediatric asthma assessment: validation of 2 symptom diaries
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.
Abstract:
Accurate assessment of the value of asthma interventions in pediatric clinical trials is an essential step toward the improvement of the treatment of this disorder in children. Conventional pulmonary function measures can be infeasible and unreliable in younger children, particularly for use in multisite studies. As an alternative or supplemental approach, diary questionnaires completed by the patients or their caregivers may provide valuable data regarding the efficacy of asthma interventions in pediatric clinical trials. These questionnaires, however, have routinely not been validated for use in pediatric populations. Two pediatric diary questionnaires (the child-completed Pediatric Asthma Diary [PAD] and the parent/caregiver-completed Pediatric Asthma Caregiver Diary [PACD]) were designed to evaluate asthma symptoms in children aged 6 to 14 years and 2 to 5 years, respectively. The validity of these diary questionnaires was evaluated in 2 separate prospective studies that included children who were divided into 2 asthma groups: stable (requiring no additional asthma medication) and unstable (requiring either an increase in or the addition of asthma medication). Both scales displayed significant discriminant validity, construct validity, and responsiveness to change in asthma therapy. Only the PACD detected differences between groups in nighttime symptoms, such as awakenings caused by asthma. These validity studies suggest that diary questionnaires such as the PAD and PACD can be valuable as an alternative for the evaluation of interventions in pediatric asthma when pulmonary function testing is inappropriate or as an adjunct to such objective measures.
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