Development of an Item Bank to Assess Patient-Reported Outcomes: Signs, Symptoms, and Impacts of COVID-19.

ABSTRACT

BACKGROUND AND OBJECTIVE: Patients experience a wide range of signs, symptoms, and impacts related to coronavirus disease 2019 (COVID-19). A patient-reported outcome (PRO) item bank that measures the most relevant patient experiences is needed to fully evaluate treatment benefit in COVID-19 clinical trials. METHODS: A review of the literature and social media informed a novel PRO item bank of COVID-19 signs, symptoms, and impacts and general pandemic impacts. Twenty 11 concept elicitation and cognitive debriefing interviews were conducted with adults in the US who had symptomatic COVID-19. A conceptual model was developed and the PRO item bank refined following interviews. RESULTS: A heterogenous set of signs, symptoms, and impacts of COVID-19, as well as impacts associated with the pandemic overall, was identified. Fifty-five short-term and long-term signs and symptom items, 26 items assessing disease-related impacts, and seven items evaluating pandemic-related impacts are included in the item bank. CONCLUSIONS: The novel and preliminarily content-valid IQVIA COVID-19 Daily Diary Item Bank© and the IQVIA COVID-19 Weekly Diary Item Bank© were developed to measure signs and symptoms, their associated severity, and disease-related and pandemic-related impacts. The items are arranged in seven groups and can be individually selected based on research needs.