Measure/checklist | Description and response scale | Time points for completion |
---|---|---|
Child Cold Symptom Questionnaire (CCSQ) | Child completed PRO consisting of 32 items (15 morning; 17 afternoon) Evidence of validity as a measure of cold symptom in children has been previously confirmed [5] Items all answered on a five-point verbal descriptor scale (scored from 0 to 4) | Completed by all participants (including adults) on the mornings and afternoons of Days 2, 5 and 8 |
Child Cold Symptom Checklist for Chest Congestion (CCSC-CC) | 9-item checklist assessing chest congestion symptoms Responses on the CCSC-CC were recorded on a five-point verbal descriptor scale. Developed as a screening tool during previous research in a pediatric common cold population [5] | Administered at screening to ensure participants were experiencing an adequate number and severity of cold symptoms for inclusion in the study. Also included to assess child participants’ reading ability |
Child Global Impression of Severity (CGI-S) | Single-item global assessment asking “How bad is your cold today?” Answers recorded on a 0–4 verbal descriptor response scale (‘no cold’, ‘a tiny bit bad’, ‘a little bad’, ‘bad’ and ‘very bad’). The CGI-S item was drafted in line with common practice for static global impression items assessing disease severity [7, 8]. Further, the descriptor words used for the CGI-S response scale (e.g., ‘a tiny bit’ and a ‘little bit’) were similar to those included in the chest-related ePRO itself, where cognitive debriefing (CD) evidence suggested good understanding of response scales [6] | The CGI-S was completed by all participants at Visit 1 and each afternoon during the ten day at-home completion period |
Child Global Impression of Change (CGI-C) | The CGI-C was a single global item which asks “How much has your cold changed since Visit 1 when you started the study? Response options: ‘much better’, ‘a little better’, ‘the same’, ‘a little worse’, ‘much worse’. Similar to the CGI-S, the CGI-C item was drafted in line with common practice for impression of change items, and ensuring appropriate wording for pediatric completion [7, 8] | The CGI-S was completed by all participants at Visit 1 and each afternoon during the ten day at-home completion period |