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Development and content validation of a self-completed, electronic Pediatric Asthma Symptom Diary
Marci Clark1, Carla Romano2, Oyebimpe Olayinka-Amao2
1RTI Health Solutions, Ann Arbor, MI, USA. mclark@rti.org.
Insights
A new electronic Pediatric Asthma Symptom Diary (ePASD) was developed for children aged 6-11 years. This tool captures self-reported asthma symptoms and impacts, addressing an unmet need in childhood asthma care.
Area of Science:
- Pediatric pulmonology
- Digital health tools
- Patient-reported outcomes
Background:
- Childhood asthma presents a significant unmet need for effective management tools.
- Current patient-reported outcome measures (PROMs) for pediatric asthma often rely on caregivers or older children, lacking a comprehensive self-report option for younger age groups.
- There is a need for a validated tool to assess asthma symptom severity and impact in children aged 6-11 years.
Purpose of the Study:
- To develop a novel, interactive, electronic Pediatric Asthma Symptom Diary (ePASD).
- To measure self-reported asthma symptom severity and proximal impacts in young children (6-11 years).
- To ensure the ePASD aligns with US Food and Drug Administration (FDA) PRO guidance and International Society for Health Economics and Outcomes Research (ISPOR) best practices.
Main Methods:
- Conducted a literature review and clinician interviews to identify key asthma symptoms and impacts.
- Performed concept elicitation interviews (CEIs) with 44 children and caregivers (US/UK).
- Developed the ePASD and assessed its relevance, understanding, and interpretability through cognitive debriefing interviews (CDIs) with 21 US children.
Main Results:
- Key concepts identified include cough, wheeze, breathing difficulty, chest tightness, nighttime awakenings, and activity limitations.
- CEIs reached concept saturation for primary asthma symptoms and impacts.
- Cognitive debriefing indicated that most child participants found the ePASD items clear, understandable, and comprehensive.
Conclusions:
- The ePASD is a novel, multimedia-based patient-reported outcome measure for children aged 6-11 years with asthma.
- Developed following FDA PRO and ISPOR guidelines, it captures child self-reported symptoms, daily impacts, nighttime awakenings, and rescue medication use.
- Standardized training is expected to support reliable self-reporting by children.
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 (ISPOR) good research practices.
Methods:
A targeted literature review and clinician interviews were undertaken to characterize symptoms and impacts experienced by children with mild-to-severe asthma. Concept elicitation interviews (CEIs) were conducted with 44 children and their caregivers (30 US; 14 UK). Following item and digital application development, the ePASD was assessed for relevance, understanding, and interpretability through cognitive debriefing interviews (CDIs) with 21 US children. Face validity/translatability assessments were also performed.
Results:
Key measurement concepts included cough, wheeze, difficulty breathing, chest tightness/discomfort, nighttime awakening, and daytime activity limitations. Concept saturation was reached during CEIs for primary asthma-related daytime and nighttime symptoms and core impacts. Most CDI participants found the ePASD items clear, understandable, and comprehensive. Standardized training is anticipated to facilitate reliable child self-report.
Conclusion:
The ePASD, a novel PROM for children aged 6-11 years with asthma, uses an innovative multimedia approach and has been developed in accordance with FDA PRO guidance and ISPOR good research practices, directly capturing the child's self-reported asthma symptoms, impacts on daily activities and nighttime awakening, and rescue medication use.
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