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

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

doi:10.1093/ofid/ofab517

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

Epidemiology, Immunology, and Clinical Characteristics of Pandemic Infectious Diseases (EPICC) COVID-19 Cohort Study Groupa, Stephanie A. Richard, Nusrat J. Epsi, Simon Pollett, David A. Lindholm, Allison M.W. Malloy, Ryan Maves, Gregory C. Utz, Tahaniyat Lalani, Alfred G. Smith, Rupal M. Mody, Anuradha Ganesan, Rhonda E. Colombo, Christopher J. Colombo, Sharon W. Chi, Nikhil Huprikar, Derek T. Larson, Samantha Bazan, Cristian Madar, Charlotte LanteriJulia S. Rozman, Caroline English, Katrin Mende, David R. Tribble, Brian K. Agan, Timothy H. Burgess, John H. Powers^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

15 Scopus citations

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.

Original language	English
Article number	ofab517
Journal	Open Forum Infectious Diseases
Volume	8
Issue number	12
DOIs	https://doi.org/10.1093/ofid/ofab517
State	Published - 1 Dec 2021
Externally published	Yes

Keywords

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

Access to Document

10.1093/ofid/ofab517

Cite this

Epidemiology, Immunology, and Clinical Characteristics of Pandemic Infectious Diseases (EPICC) COVID-19 Cohort Study Groupa, Richard, S. A., Epsi, N. J., Pollett, S., Lindholm, D. A., Malloy, A. M. W., Maves, R., Utz, G. C., Lalani, T., Smith, A. G., Mody, R. M., Ganesan, A., Colombo, R. E., Colombo, C. J., Chi, S. W., Huprikar, N., Larson, D. T., Bazan, S., Madar, C., ... Powers, J. H. (2021). Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019. Open Forum Infectious Diseases, 8(12), Article ofab517. https://doi.org/10.1093/ofid/ofab517

@article{71eaebb362e94d549d5ddce18d9c24ff,

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

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",

author = "{Epidemiology, Immunology, and Clinical Characteristics of Pandemic Infectious Diseases (EPICC) COVID-19 Cohort Study Groupa} and Richard, {Stephanie A.} and Epsi, {Nusrat J.} and Simon Pollett and Lindholm, {David A.} and Malloy, {Allison M.W.} and Ryan Maves and Utz, {Gregory C.} and Tahaniyat Lalani and Smith, {Alfred G.} and Mody, {Rupal M.} and Anuradha Ganesan and Colombo, {Rhonda E.} and Colombo, {Christopher J.} and Chi, {Sharon W.} and Nikhil Huprikar and Larson, {Derek T.} and Samantha Bazan and Cristian Madar and Charlotte Lanteri and Rozman, {Julia S.} and Caroline English and Katrin Mende and Tribble, {David R.} and Agan, {Brian K.} and Burgess, {Timothy H.} and Powers, {John H.}",

note = "Funding Information: This work was supported by awards from the Defense Health Program (award number HU00012020067) and the National Institute of Allergy and Infectious Diseases (NIAID) (award number HU00011920111). The protocol was executed by the IDCRP, a DoD program executed by the USUHS through a cooperative agreement by HJF. This project has been funded in part by the NIAID at the NIH, under interagency agreement Y1-AI-5072. This project was funded in whole or in part with federal funds from the National Cancer Institute, NIH (contract number HHSN261200800001E 75N910D00024, task order number 75N91019F00130). Publisher Copyright: {\textcopyright} 2021 Published by Oxford University Press on behalf of Infectious Diseases Society of America.",

year = "2021",

month = dec,

day = "1",

doi = "10.1093/ofid/ofab517",

language = "English",

volume = "8",

journal = "Open Forum Infectious Diseases",

issn = "2328-8957",

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Epidemiology, Immunology, and Clinical Characteristics of Pandemic Infectious Diseases (EPICC) COVID-19 Cohort Study Groupa, Richard, SA, Epsi, NJ, Pollett, S , Lindholm, DA, Malloy, AMW, Maves, R, Utz, GC, Lalani, T, Smith, AG, Mody, RM, Ganesan, A , Colombo, RE , Colombo, CJ, Chi, SW, Huprikar, N, Larson, DT, Bazan, S, Madar, C, Lanteri, C, Rozman, JS, English, C, Mende, K , Tribble, DR , Agan, BK , Burgess, TH & Powers, JH 2021, 'Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019', Open Forum Infectious Diseases, vol. 8, no. 12, ofab517. https://doi.org/10.1093/ofid/ofab517

Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019. / Epidemiology, Immunology, and Clinical Characteristics of Pandemic Infectious Diseases (EPICC) COVID-19 Cohort Study Groupa ; Richard, Stephanie A.; Epsi, Nusrat J. et al.
In: Open Forum Infectious Diseases, Vol. 8, No. 12, ofab517, 01.12.2021.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019

AU - Epidemiology, Immunology, and Clinical Characteristics of Pandemic Infectious Diseases (EPICC) COVID-19 Cohort Study Groupa

AU - Richard, Stephanie A.

AU - Epsi, Nusrat J.

AU - Pollett, Simon

AU - Lindholm, David A.

AU - Malloy, Allison M.W.

AU - Maves, Ryan

AU - Utz, Gregory C.

AU - Lalani, Tahaniyat

AU - Smith, Alfred G.

AU - Mody, Rupal M.

AU - Ganesan, Anuradha

AU - Colombo, Rhonda E.

AU - Colombo, Christopher J.

AU - Chi, Sharon W.

AU - Huprikar, Nikhil

AU - Larson, Derek T.

AU - Bazan, Samantha

AU - Madar, Cristian

AU - Lanteri, Charlotte

AU - Rozman, Julia S.

AU - English, Caroline

AU - Mende, Katrin

AU - Tribble, David R.

AU - Agan, Brian K.

AU - Burgess, Timothy H.

AU - Powers, John H.

N1 - Funding Information: This work was supported by awards from the Defense Health Program (award number HU00012020067) and the National Institute of Allergy and Infectious Diseases (NIAID) (award number HU00011920111). The protocol was executed by the IDCRP, a DoD program executed by the USUHS through a cooperative agreement by HJF. This project has been funded in part by the NIAID at the NIH, under interagency agreement Y1-AI-5072. This project was funded in whole or in part with federal funds from the National Cancer Institute, NIH (contract number HHSN261200800001E 75N910D00024, task order number 75N91019F00130). Publisher Copyright: © 2021 Published by Oxford University Press on behalf of Infectious Diseases Society of America.

PY - 2021/12/1

Y1 - 2021/12/1

N2 - 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.

AB - 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.

KW - COVID-19

KW - SARS-CoV-2

KW - clinical studies

KW - clinical trials

KW - endpoints

KW - measurement properties

KW - patient-reported outcomes

KW - symptom scales

KW - symptoms

KW - validity

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U2 - 10.1093/ofid/ofab517

DO - 10.1093/ofid/ofab517

M3 - Article

AN - SCOPUS:85124907582

SN - 2328-8957

VL - 8

JO - Open Forum Infectious Diseases

JF - Open Forum Infectious Diseases

IS - 12

M1 - ofab517

ER -

Epidemiology, Immunology, and Clinical Characteristics of Pandemic Infectious Diseases (EPICC) COVID-19 Cohort Study Groupa, Richard SA, Epsi NJ, Pollett S , Lindholm DA, Malloy AMW et al. Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019. Open Forum Infectious Diseases. 2021 Dec 1;8(12):ofab517. doi: 10.1093/ofid/ofab517

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

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Keywords

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