BACKGROUND: The Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome (PRO) measure developed to assess the presence and severity of COVID-19 signs and symptoms in adults. To further facilitate the evaluation of new vaccines and treatments in development, similar tools are needed for use within pediatric populations. The objectives of this study were to support adolescent self-completion and create an adaptation of the measure for caregiver assessment of signs and symptoms in children aged < 12 years (henceforth, the Pediatric SIC [PedSIC]).
METHODS: After developing draft versions of the PedSIC and reference materials with definitions to facilitate accurate completion of both measures, iterative rounds of cognitive debriefing interviews were conducted from November 2020 through January 2021 to evaluate understanding of the SIC (in adolescents aged 12-17), and inform refinement of the PedSIC for caregivers of children aged <12. Recruitment quotas were employed to support sample diversity.
RESULTS: Nine adolescents (mean [SD, range] age, 14 [1.76, 12-17] years, 56% female, 78% white; round 1, n=6; round 2, n=3) and 17 caregivers (mean [SD, range] age, 34 [6.28, 26-41] years, 59% female, 65% white; round 1, n=9; round 2, n=8) completed interviews. All adolescents understood and completed the adult version of the SIC without instrument modification. Ease and accuracy of self-completion was improved through the use of reference materials. Caregiver feedback resulted in modification of the PedSIC to include two sections: observable signs (ages < 12), and symptoms assessed with input from children (ages ≥5 -<12). Reference materials provided standardization of item intent.
CONCLUSIONS: Results support using the SIC, PedSIC, and their associated reference materials to assess the presence and severity of COVID-19 signs/symptoms in adolescents and children aged < 12 years, respectively, who participate in vaccine and treatment clinical trials. Supported by Janssen Vaccines & Prevention B.V.
