LAUSR

Objectives: In this unprecedented era of conducting clinical research during a global pandemic a Patient-Reported Outcomes (PRO) tool is required to (1) provide a comprehensive epidemiological understanding of SARS-COV-2 (COVID-19) symptoms, clustering and resolution;(2) provide data on the impact of both infection and the pandemic on people’s lives;and (3) offer a full understanding of treatment benefit in studies designed to treat or vaccinate against COVID-19 Methods: A review of the literature (March 2020) used COVID-19 and signs, symptoms and impacts search terms A preliminary conceptual model was developed and novel PRO items were drafted A review of social media (June 2020) informed an updated conceptual model and PRO items Joint concept elicitation-cognitive interviews were completed with people who had experienced COVID-19 (June-July 2020) Results: The literature (25 articles), social media (>200 million mentions) and interviews (n=10) highlighted a heterogenous list of signs, symptoms and impacts of COVID-19 infections, and a broad list of impacts of the pandemic in general Novel PROs are intended to be comprehensive, so the incidence and severity of 42 signs and symptoms are measured Fifteen additional items ask about the impact of infection (physical, emotional and social) and 18 about the impact of the pandemic The PRO is adaptive (modular) to allow administration to people with and without COVID-19 infection Weekly- and daily-recall versions were tested in cognitive interviews resulting in adjustments to ensure understandability Conclusions: Novel content-valid PROs have been developed to measure the signs, symptoms and impacts of COVID-19 pandemic and infection These are currently being employed in a large longitudinal study to evaluate their psychometric measurement properties