Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Oct 8;8(12):ofab517.
doi: 10.1093/ofid/ofab517. eCollection 2021 Dec.

Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019

Stephanie A Richard  1   2 , Nusrat J Epsi  1   2 , Simon Pollett  1   2 , David A Lindholm  3   4 , Allison M W Malloy  4 , Ryan Maves  1   5 , Gregory C Utz  1   2   5 , Tahaniyat Lalani  1   2   6 , Alfred G Smith  6 , Rupal M Mody  7 , Anuradha Ganesan  1   2   8 , Rhonda E Colombo  1   2   9 , Christopher J Colombo  4   9 , Sharon W Chi  1   2   10 , Nikhil Huprikar  4   8 , Derek T Larson  4   11 , Samantha Bazan  12 , Cristian Madar  10 , Charlotte Lanteri  1 , Julia S Rozman  1   2 , Caroline English  1   2 , Katrin Mende  1   2   3 , David R Tribble  1 , Brian K Agan  1   2 , Timothy H Burgess  1 , John H Powers 3rd  13 ; Epidemiology, Immunology, and Clinical Characteristics of Pandemic Infectious Diseases (EPICC) COVID-19 Cohort Study Group
Collaborators, Affiliations

Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019

Stephanie A Richard et al. Open Forum Infect Dis. .

Abstract

Background: The inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) is a patient-reported outcome data collection instrument assessing symptoms of viral respiratory tract infections across 8 body systems. This study evaluated the measurement properties of FLU-PRO Plus in a study enrolling individuals with coronavirus disease 2019 (COVID-19).

Methods: Data from a prospective cohort study (EPICC) in US Military Health System beneficiaries evaluated for COVID-19 was utilized. Adults with symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with FLU-PRO Plus survey information within 1 week of symptom onset were included. Reliability of FLU-PRO Plus was estimated using intraclass correlation coefficient (ICC; 2 days' reproducibility). Known-groups validity was assessed using patient global assessment (PGA) of disease severity. Patient report of return to usual health was used to assess responsiveness (day 1-6/7).

Results: Two hundred twenty-six SARS-CoV-2-positive participants were included in the analysis. Reliability among those who reported no change in their symptoms from one day to the next was high for most domains (ICC range, 0.68-0.94 for day 1 to day 2). Construct validity was demonstrated by moderate to high correlation between the PGA rating of disease severity and domain and total scores (eg, total scores correlation: 0.69 [influenza-like illness severity], 0.69 [interference in daily activities], and -0.58 [physical health]). In addition, FLU-PRO Plus demonstrated good known-groups validity, with increasing domain and total scores observed with increasing severity ratings.

Conclusions: FLU-PRO Plus performs well in measuring signs and symptoms in SARS-CoV-2 infection with excellent construct validity, known-groups validity, and responsiveness to change. Standardized data collection instruments facilitate meta-analyses, vaccine effectiveness studies, and other COVID-19 research activities.

Keywords: COVID-19; SARS-CoV-2; clinical studies; clinical trials; endpoints; measurement properties; patient-reported outcomes; symptom scales; symptoms; validity.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Mean inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) domain and total scores, by day, in the first 2 weeks participants were enrolled in the Epidemiology, Immunology, and Clinical Characteristics of Pandemic Infectious Diseases (EPICC) cohort. Abbreviation: GI, gastrointestinal.
See this image and copyright information in PMC

References

    1. Allen WE, Altae-Tran H, Briggs J, et al. . Population-scale longitudinal mapping of COVID-19 symptoms, behaviour and testing. Nat Hum Behav 2020; 4:972–82. - PMC - PubMed
    1. Drew DA, Nguyen LH, Steves CJ, et al. . COPE Consortium. Rapid implementation of mobile technology for real-time epidemiology of COVID-19. Science 2020; 368:1362–7. - PMC - PubMed
    1. Menni C, Valdes AM, Freidin MB, et al. . Real-time tracking of self-reported symptoms to predict potential COVID-19. Nat Med 2020; 26:1037–40. - PMC - PubMed
    1. Koehlmoos TP, Janvrin ML, Korona-Bailey J, et al. . COVID-19 self-reported symptom tracking programs in the United States: framework synthesis. J Med Internet Res 2020; 22:e23297. - PMC - PubMed
    1. Quer G, Radin JM, Gadaleta M, et al. . Wearable sensor data and self-reported symptoms for COVID-19 detection. Nat Med 2021; 27:73–7. - PubMed