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

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 (...

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Main Authors: Yi Zhang, Jennifer L. Clegg, Shannon Keith, Shehan McFadden, Tara Symonds, Rajesh Kumar, Asif H. Khan, Siddhesh Kamat, Jingdong Chao
Format: Article
Language:English
Published: SpringerOpen 2022-05-01
Series:Journal of Patient-Reported Outcomes
Subjects:
Online Access:https://doi.org/10.1186/s41687-022-00461-y
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author Yi Zhang
Jennifer L. Clegg
Shannon Keith
Shehan McFadden
Tara Symonds
Rajesh Kumar
Asif H. Khan
Siddhesh Kamat
Jingdong Chao
author_facet Yi Zhang
Jennifer L. Clegg
Shannon Keith
Shehan McFadden
Tara Symonds
Rajesh Kumar
Asif H. Khan
Siddhesh Kamat
Jingdong Chao
author_sort Yi Zhang
collection DOAJ
description 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.
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spelling doaj.art-a06f8483a33245d3bf334dcdf5566abe2022-12-22T02:21:50ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202022-05-016111110.1186/s41687-022-00461-yContent validity of a newly developed observer-reported measure for pediatric asthma in children aged 2–5 yearsYi Zhang0Jennifer L. Clegg1Shannon Keith2Shehan McFadden3Tara Symonds4Rajesh Kumar5Asif H. Khan6Siddhesh Kamat7Jingdong Chao8Regeneron PharmaceuticalsClinical Outcomes Assessment, Clinical Outcomes SolutionsClinical Outcomes Assessment, Clinical Outcomes SolutionsClinical Outcomes Assessment, Clinical Outcomes SolutionsClinical Outcomes SolutionsLurie Children’s HospitalSanofiRegeneron PharmaceuticalsRegeneron PharmaceuticalsAbstract 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.https://doi.org/10.1186/s41687-022-00461-yPediatric Asthma QuestionnairePAQContent validityHealth-related quality of lifeHRQoLPatient-reported outcome
spellingShingle Yi Zhang
Jennifer L. Clegg
Shannon Keith
Shehan McFadden
Tara Symonds
Rajesh Kumar
Asif H. Khan
Siddhesh Kamat
Jingdong Chao
Content validity of a newly developed observer-reported measure for pediatric asthma in children aged 2–5 years
Journal of Patient-Reported Outcomes
Pediatric Asthma Questionnaire
PAQ
Content validity
Health-related quality of life
HRQoL
Patient-reported outcome
title Content validity of a newly developed observer-reported measure for pediatric asthma in children aged 2–5 years
title_full Content validity of a newly developed observer-reported measure for pediatric asthma in children aged 2–5 years
title_fullStr Content validity of a newly developed observer-reported measure for pediatric asthma in children aged 2–5 years
title_full_unstemmed Content validity of a newly developed observer-reported measure for pediatric asthma in children aged 2–5 years
title_short Content validity of a newly developed observer-reported measure for pediatric asthma in children aged 2–5 years
title_sort content validity of a newly developed observer reported measure for pediatric asthma in children aged 2 5 years
topic Pediatric Asthma Questionnaire
PAQ
Content validity
Health-related quality of life
HRQoL
Patient-reported outcome
url https://doi.org/10.1186/s41687-022-00461-y
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