Pediatric asthma assessment: validation of 2 symptom diaries.

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.