Development and content validation of a self-completed, electronic Pediatric Asthma Symptom Diary.

ABSTRACT:

Background

Childhood asthma is an important unmet need. To date, patient-reported outcome measures (PROMs) for children with asthma have used a combination of caregiver or proxy-reported and self-reported measures. No comprehensive measure is available to assess the severity and impact of daytime and nighttime asthma symptoms and rescue medication use for self-completion by children aged 6-11 years. This study aimed to develop a novel, interactive, electronic Pediatric Asthma Symptom Diary (ePASD) measuring self-reported key symptom severity and proximal impacts of asthma in young children with varying reading ability and disease severity, consistent with US Food and Drug Administration (FDA) PRO guidance and the International Society for Health Economics and Outcomes Research (ISP

SUBMITTER: Clark M 

PROVIDER: S-EPMC8934788 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature