Abstract

Purpose

A well-defined and reliable patient-reported outcome instrument for COVID-19 is important for assessing symptom severity and supporting research studies. The InFLUenza Patient-Reported Outcome (FLU-PRO) instrument has been expanded to include loss of taste and smell in the FLU-PRO Plus, to comprehensively cover COVID-19 symptoms. Our studies were designed to evaluate and validate the FLU-PRO Plus among patients with COVID-19.

Methods

Two studies were conducted: (1) a qualitative, non-interventional, cross-sectional study of patients with COVID-19 involving hybrid concept elicitation and cognitive debriefing interviews; (2) a psychometric evaluation of the measurement properties of FLU-PRO Plus, using data from COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial—Intent to Care Early).

Results

In the qualitative interviews (n = 30), all 34 items of the FLU-PRO Plus were considered relevant to COVID-19, and participants determined the questionnaire was easily understood, well written, and comprehensive. In the psychometric evaluation (n = 845), the internal consistency reliability of FLU-PRO Plus total score was 0.94, ranging from 0.71 to 0.90 for domain scores. Reproducibility (Day 20–21) was 0.83 for total score, with domain scores of 0.67–0.89. Confirmatory factor analysis with the novel smell/taste domain demonstrated an acceptable fit to the data.

Conclusion

The content, reliability, validity, and responsiveness of the FLU-PRO Plus in the COVID-19 population were supported. Our results suggest that FLU-PRO Plus is a content- and psychometrically-valid, fit-for-purpose measure which is easily understood by patients. FLU-PRO Plus is a suitable PRO measure for evaluating symptoms of COVID-19 and treatment benefit directly from the patient perspective.

Trial Registration: ClinicalTrials.Gov: NCT04545060, September 10, 2020; retrospectively registered.

Details

Title
Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus©) instrument in patients with COVID-19
Author
Keeley, Tom J. H. 1   VIAFID ORCID Logo  ; Satram, Sacha 2 ; Ghafoori, Parima 3 ; Reyes, Carolina 2 ; Birch, Helen J. 1   VIAFID ORCID Logo  ; Raymond, Kimberly 4 ; Gelhorn, Heather L. 5 ; Kosinski, Mark 6 ; Saucier, Cory D. 6   VIAFID ORCID Logo  ; Mitchell Foster, April 6 ; Lopuski, Amanda 3 ; Powers, John H. 7 

1  GlaxoSmithKline, Brentford, UK (GRID:grid.418236.a) (ISNI:0000 0001 2162 0389) 
2  Vir Biotechnology, San Francisco, USA (GRID:grid.507173.7) 
3  GlaxoSmithKline, Collegeville, USA (GRID:grid.418019.5) (ISNI:0000 0004 0393 4335) 
4  QualityMetric Incorporated, LLC, Johnston, USA (GRID:grid.418236.a) 
5  Evidera, Bethesda, USA (GRID:grid.423257.5) (ISNI:0000 0004 0510 2209) 
6  QualityMetric Incorporated, LLC, Johnston, USA (GRID:grid.423257.5) 
7  George Washington University School of Medicine, Washington, USA (GRID:grid.253615.6) (ISNI:0000 0004 1936 9510) 
Pages
1645-1657
Publication year
2023
Publication date
Jun 2023
Publisher
Springer Nature B.V.
ISSN
09629343
e-ISSN
15732649
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1007/s11136-022-03336-3
ProQuest document ID
2811778249
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.