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

Matthew Reaney (), James Turnbull, Jean Paty, Karli Heuer and Chad Gwaltney
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Matthew Reaney: IQVIA
James Turnbull: IQVIA
Jean Paty: IQVIA
Karli Heuer: IQVIA
Chad Gwaltney: Gwaltney Consulting

The Patient: Patient-Centered Outcomes Research, 2022, vol. 15, issue 6, No 11, 703-713

Abstract: 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 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.

Date: 2022
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DOI: 10.1007/s40271-022-00591-x

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