Development of a novel patient-reported outcome measure to assess signs and symptoms of COVID-19.

ABSTRACT:

Background

Given the urgent need for vaccines and treatments for coronavirus disease 2019 (COVID-19), the Symptoms of Infection with Coronavirus-19 (SIC), a comprehensive, patient-reported outcome (PRO) measure of signs and symptoms associated with COVID-19, was developed in full alignment with current US regulatory guidance to support evaluations of vaccines and treatments in development.

Methods

An initial version of the SIC was developed to address concepts identified through a targeted literature review and consultation with experts in infectious diseases and clinicians routinely managing COVID-19 in a hospital setting. A qualitative study was conducted in sites in the United States among 31 participants aged ≥ 18 years who were English-speaking and willing and able to p

SUBMITTER: Romano C 

PROVIDER: S-EPMC9336135 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature