Development of an Item Bank to Assess Patient-Reported Outcomes: Signs, Symptoms, and Impacts of COVID-19.
Patient
; 15(6): 703-713, 2022 11.
Article
in English
| MEDLINE | ID: covidwho-1943544
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Patient Reported Outcome Measures
/
COVID-19
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Qualitative research
/
Randomized controlled trials
Topics:
Long Covid
Limits:
Adult
/
Humans
Language:
English
Journal:
Patient
Year:
2022
Document Type:
Article
Affiliation country:
S40271-022-00591-x
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