Testing and Psychometric Validation of a Pediatric Instrument to Self-Assess Symptoms of the Common Cold
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ORIGINAL RESEARCH ARTICLE
Testing and Psychometric Validation of a Pediatric Instrument to Self‑Assess Symptoms of the Common Cold Rob Arbuckle1 · Patricia Halstead2 · Chris Marshall1 · Brenda Zimmerman2 · Kate Bolton1 · Antoine Regnault3 · Cathy Gelotte2 Accepted: 19 September 2020 © The Author(s) 2020
Abstract Objectives Given the lack of validated patient-reported outcomes (PRO) instruments assessing cold symptoms, a new pediatric PRO instrument was developed to assess multiple cold symptoms: the Child Cold Symptom Questionnaire (CCSQ). The objective of this research was to evaluate the measurement properties of the CCSQ. Methods This observational study involved daily completion of the self-report CCSQ by children aged 6–11 years in their home for 7 days. These data were used to develop a scoring algorithm and item-scale structure and evaluate the psychometric properties of the resulting scores. Analyses included evaluation of item and dimensionality performance (item response distributions and confirmatory factor analysis) and assessment of test–retest reliability in stable patients, construct validity (convergent and known groups validity), and preliminary responsiveness. Qualitative exit interviews in a subgroup of the children with colds and their parents were conducted. Results More than 90% of children had no missing data during the testing period, reflecting an excellent completion rate. For most items, responses were distributed across the options, with approximately normal distributions. Test–retest reliability was adequate, with intra-class correlation coefficients ranging from 0.63 to 0.83. A logical pattern of correlations with the validated Strep-PRO instrument provided evidence supporting convergent validity. Single- and multi-item symptom scores distinguished between children who differed in their cold severity based on global ratings, providing evidence of known groups validity. Preliminary evidence indicates the CCSQ is responsive to changes over time. Conclusions The findings demonstrate that the CCSQ items and multi-item scores provide valid and reliable patient-reported measures of cold symptoms in children aged 6–11 years. They provide strong evidence supporting the validity of these items and multi-item scores for inclusion as endpoints in clinical trials to evaluate the efficacy of cold medicines.
Key Points for Decision Makers
Chris Marshall and Kate Bolton were working for Adelphi Values (known at the time as Mapi Values) at the time the research was conducted. Patricia Halstead, Brenda Zimmerman and Cathy Gelotte were working for McNeil Consumer Healthcare at the time the research was conducted. Antoine Regnault is affiliated to Modus Outcomes and was working for Mapi Values at the time the work was conducted.
The psychometric validation of a child self-report measure of common cold symptoms in children aged 6–11 years is described. The single-item and multi-item scores are valid and reliable in children aged 6–11 years. The measure is appropriate for assessing cold symptom
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