Testing and Psychometric Validation of a Pediatric Instrument to Self-Assess Symptoms of the Common Cold

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. Electronic supplementary material The online version of this article (10.1007/s40271-020-00462-3) contains supplementary material, which is available to authorized users.

Psychometric validation and testing of the 10-item pediatric daily chest-related electronic patient reported outcome (ePRO) diary

“…Floor effects were observed at Day 10, but this is consistent with the duration of URTI symptoms in published research, and thus provides support for the validity of the measure [ 13 ]. The decrease in symptom severity observed on the chest-related ePRO across the study period was also in line symptom trajectories illustrated in past research on The Canadian Acute Respiratory Illness and Flu Scale (CARIFS) [ 14 ] and CCSQ [ 5 ]. However, as neither the CARIFS nor CCSQ measure chest congestion specifically, the chest-related ePRO could be used to address this gap in conceptual coverage in instances where assessment of chest congestion symptoms is important.…”

“…Eligible participants experiencing symptoms associated with an acute URTI, were then enrolled into the study by the recruiting clinician within 72 h of onset of cold symptoms. Participants were eligible if they responded at least ’some’ or ‘hard’ for one of the three chest congestion symptoms and at least ‘some’ for one of the other cold symptoms present on the Child Cold Symptoms Checklist for Chest Congestion (CCSC-CC) [ 5 ] at the time of the initial telephone screening and at Visit 1. The CCSC-CC was developed based on the CCSQ during the development of the CCSQ for the purpose of identifying/screening children with the common cold for inclusion in a research study.…”

Development and content validity testing of patient-reported outcome (PRO) items to assess chest congestion associated with the common cold for use in children and adolescents

“…Moreover, valid and reliable PRO measures are arguably essential for evaluating severity in a condition defined by symptoms experienced by the patient such as chest congestion. The research described in this paper builds upon previous work conducted to develop and psychometrically validate a PRO measure—the Child Cold Symptom Questionnaire (CCSQ)—to assess the most important and burdensome cold symptoms in children aged 6–11 years [ 8 , 9 ]. During the development of the CCSQ it was recognised that chest congestion is a particularly difficult symptom to assess accurately in pediatric populations.…”

“…Robust, well-established methodologies exist for the development of PROs in adults as summarised by the US Food and Drug Administration (FDA) [ 10 ]. These methods can be applied to pediatric work but with additional considerations not encountered in adults [ 8 , 9 , 11 – 13 ]. For example, wide variation exists in linguistic, cognitive, and motor capacities among children of the same age.…”

Objective and self‐reported evidence of dextromethorphan antitussive efficacy in children, aged 6–11 years, with acute cough due to the common cold

“…Compared with the initial pilot study, 13 the assay sensitivity to distinguish treatment effects was improved by incorporating age‐appropriate assessment tools validated in children, specifically, the ambulatory cough monitor and subjective self‐reported assessments of cough 15–17 . Another key contributing factor was the selection of appropriate subjects.…”