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. 2022 May 28;6(1):55.
doi: 10.1186/s41687-022-00461-y.

Content validity of a newly developed observer-reported measure for pediatric asthma in children aged 2-5 years

Yi Zhang  1 , Jennifer L Clegg  2 , Shannon Keith  3 , Shehan McFadden  3 , Tara Symonds  4 , Rajesh Kumar  5 , Asif H Khan  6 , Siddhesh Kamat  1 , Jingdong Chao  1
Affiliations

Content validity of a newly developed observer-reported measure for pediatric asthma in children aged 2-5 years

Yi Zhang et al. J Patient Rep Outcomes. .

Abstract

Background: An observer-reported outcome (ObsRO) measure assessing both symptom control and health-related quality of life (HRQoL) in children with asthma younger than 6 years is lacking. The objective of this study was to evaluate the content validity of the Pediatric Asthma Questionnaire (PAQ), a newly developed 6-item ObsRO measure for caregivers of children aged 2-5 years diagnosed with asthma.

Results: In-depth, qualitative interviews were conducted with 15 parents or caregivers. The first part of the interview was an open-ended discussion whereby participants were asked to describe their observations of their child's asthma symptoms and HRQoL impacts followed by a cognitive debriefing of a draft version of the PAQ. The most frequently reported symptoms were coughing (n = 15, 100%), wheezing (n = 14, 93%), and trouble breathing (n = 10, 67%). Overall, participants found the PAQ easy to complete and relevant to their child's experience with asthma, with most reporting the instructions, response scales, and recall period for the items to be appropriate. The majority of participants (93%) believed they could accurately report on the items included in the PAQ based on their observations of their child's asthma symptoms and impacts, or reliably get the information from the child's teacher, school, or caregiver when their child was not in their presence. One item was modified based on feedback about the phrase "oral steroids" to clarify modes of administration. A few other minor changes were incorporated into the PAQ following suggestions from participants, including replacing the phrase "how often" with "how many days" in one of the items to improve clarity and overall consistency with the response options.

Conclusion: Qualitative data support the content validity of the PAQ as a fit-for-purpose and well-understood 6-item observer-reported outcome measure to evaluate both symptoms and asthma-specific HRQoL impacts experienced by pediatric asthma patients aged 2-5 years for use in clinical and real-world studies.

Keywords: Asthma; Content validity; HRQoL; Health-related quality of life; ObsRO; Observer-reported outcome; PAQ; PRO; Patient-reported outcome; Pediatric; Pediatric Asthma Questionnaire.

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Conflict of interest statement

JC, SK, and YZ are employees of Regeneron Pharmaceuticals, Inc. AHK is an employee of Sanofi, France. JC, SK, SM, and TS are employees of Clinical Outcomes Solutions, who designed and undertook this research. RK declares no competing interests.

Figures

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Fig. 1
Summary of interview procedures
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