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.