Development and Content Validity Testing of Patient-Reported Outcome Items for Children to Self-Assess Symptoms of the Common Cold

Patricia Halstead, Rob Arbuckle (), Chris Marshall, Brenda Zimmerman, Kate Bolton and Cathy Gelotte
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Patricia Halstead: McNeil Consumer Healthcare, a Division of Johnson & Johnson Consumer Inc.
Rob Arbuckle: Adelphi Values
Chris Marshall: Adelphi Values
Brenda Zimmerman: McNeil Consumer Healthcare, a Division of Johnson & Johnson Consumer Inc.
Kate Bolton: Adelphi Values
Cathy Gelotte: McNeil Consumer Healthcare, a Division of Johnson & Johnson Consumer Inc.

The Patient: Patient-Centered Outcomes Research, 2020, vol. 13, issue 2, No 9, 235-250

Abstract: Abstract 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.

Date: 2020
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DOI: 10.1007/s40271-019-00404-8

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