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 1:1 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 associ

SUBMITTER: Reaney M 

PROVIDER: S-EPMC9296757 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature