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Development and Content Validity Testing of Patient-Reported Outcome Items for Children to Self-Assess Symptoms of
Patricia Halstead1, Rob Arbuckle2, Chris Marshall3
1McNeil Consumer Healthcare, a Division of Johnson & Johnson Consumer Inc., Fort Washington, PA, USA.
Insights
Researchers developed and validated patient-reported outcome instruments for assessing common cold symptoms in children aged 6-11 years. These new tools improve the measurement of pediatric cold experiences.
Area of Science:
- Pediatric Health
- Patient-Reported Outcomes
- Symptom Measurement
Background:
- No existing patient-reported outcome instruments specifically address the common cold in pediatric populations.
- This study aimed to fill this gap by developing and testing new instruments.
Purpose of the Study:
- To develop and conduct content validity testing of patient-reported outcome items for assessing common cold symptoms in children aged 6-11 years.
- To ensure the developed items are relevant, understandable, and interpretable by the target pediatric population.
Main Methods:
- Utilized literature review and existing measures to draft initial items.
- Conducted qualitative interviews with 39 children and 10 parents, employing concept elicitation, creative tasks, and cognitive debriefing.
- Performed thematic analysis of interview transcripts to refine the patient-reported outcome items.
Main Results:
- Identified ten key symptom concepts reported by children.
- Developed 19 patient-reported outcome items, with cognitive debriefing indicating most items were easily understood and consistently interpreted.
- Confirmed content validity and usability of the items for children aged 9 years and older.
Conclusions:
- Successfully developed and refined patient-reported outcome items for pediatric common cold symptom assessment.
- The developed items demonstrate content validity and are recommended for use in children aged 9 and older.
- For younger children (6-8 years), supervised administration is advised to ensure accurate understanding and reporting.
Background And Objective:
No pediatric patient-reported outcome instruments specific to the common cold are found in the literature. This study involved development and content validity testing of patient-reported outcome items (questions and response options) assessing cold symptoms in children aged 6-11 years.
Methods:
Draft patient-reported outcome instructions, items, response scales, and recall periods were developed based on the literature and existing measures. Qualitative interviews were conducted with children (n = 39) who were currently (n = 31) or had recently (n = 8) experienced a cold and ten parents of a subset of children aged 6-8 years. The interviews were conducted over two rounds and included open-ended concept elicitation questioning, a free-drawing task, a card sorting task, and a task involving circling parts of the body, followed by cognitive debriefing of draft items. Thematic analysis of verbatim transcripts was performed to analyze the qualitative data. The findings were used to support revisions to the draft patient-reported outcome.
Results:
Ten symptom concepts were reported by the children during concept elicitation. The creative tasks helped the children to describe their symptoms, generally using consistent language to do so, irrespective of age. Nineteen patient-reported outcome items were developed and subject to cognitive debriefing. Debriefing with both children and parents informed several small revisions and provided evidence that the majority of children found most patient-reported outcome items easy to understand, and that the items were mainly interpreted consistently and as intended.
Conclusions:
This in-depth qualitative study has supported identification of relevant symptom concepts and the development and refinement of patient-reported outcome items to assess those concepts. The findings support the content validity of the items and suggest that they can be used with confidence in children aged 9 years and older. For children aged 6-8 years, it is recommended the items are administered with initial adult supervision to explain the more difficult concepts or through parent/interviewer administration.
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