Williams V, Romano (DeMuro) C, Clark M, Goss D, Naujoks C, Marvel J. Psychometric evaluation of a new electronic pediatric asthma symptom diary. Poster presented at the ISPOR Europe 2022; November 8, 2022. Vienna, Austria.

OBJECTIVES: We developed an electronic pediatric asthma symptom diary (ePASD) to assess the severity of daily asthma symptoms and proximal impacts in children with asthma. The unique design of the ePASD minimizes the importance of reading skills on children’s ability to self-report accurately and reduces the bias of proxy report. This observational, prospective study evaluated the psychometric properties of the ePASD.

METHODS: Ninety-one children aged 6-to-11 years with mild to severe asthma and their caregivers participated. The children and caregivers received training and completed asthma-specific clinical outcome assessment (COA) questionnaires at two study visits. The children self-completed the ePASD at home twice daily for 8 days. Factor analyses, inter-item correlations, and internal consistencies guided ePASD scoring. Reliability, construct validity, discriminating ability, and responsiveness were evaluated for ePASD items and candidate composite scores.

RESULTS: All COAs, including the ePASD, Asthma Control Questionnaire (ACQ), Childhood Asthma Control Test, Pediatric Asthma Quality of Life Questionnaire–Standardized [PAQLQ(S)], and global ratings demonstrated that the children exhibited few asthma-related symptoms and impacts at all timepoints, and consequently, showed little change over time. Internal consistencies (all Cronbach’s alphas ≥ 0.52) and test-retest reliabilities (all intraclass correlation coefficients ≥ 0.63) were generally satisfactory, with minor exceptions. Patterns of validity correlations supported the construct validity of ePASD composites. As predicted, ePASD symptom scores correlated moderately to strongly with PAQLQ(S) Symptom scores (all correlations ≥ –0.46) and with ACQ scores (all correlations ≥ 0.42). Known-groups analyses supplied evidence of the discriminating ability of ePASD items and composite scores.

CONCLUSIONS: The ePASD is a reliable and valid self-report measure of asthma symptoms and proximal impacts in young children. These findings lay the psychometric groundwork for use of the ePASD in future clinical trials. Additional evaluation of responsiveness in prospective interventional studies is currently planned.

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