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Table 1 PRO measures and checklists administered during the study to aid validation of the chest-related ePRO

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

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