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

  1. Author:
    Richard, Stephanie A [ORCID]
    Epsi, Nusrat J
    Pollett, Simon
    Lindholm, David A
    Malloy, Allison M W
    Maves, Ryan
    Utz, Gregory C
    Lalani, Tahaniyat [ORCID]
    Smith, Alfred G
    Mody, Rupal M
    Ganesan, Anuradha
    Colombo, Rhonda E
    Colombo, Christopher J
    Chi, Sharon W
    Huprikar, Nikhil
    Larson, Derek T
    Bazan, Samantha
    Madar, Cristian
    Lanteri, Charlotte
    Rozman, Julia S
    English, Caroline
    Mende, Katrin
    Tribble, David R
    Agan, Brian K [ORCID]
    Burgess, Timothy H
    Powers,John

  2. Author Address

    Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA., The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, Maryland, USA., Brooke Army Medical Center, Fort Sam Houston, Texas, USA., Naval Medical Center San Diego, San Diego, California, USA., Naval Medical Center Portsmouth, Portsmouth, Virginia, USA., William Beaumont Army Medical Center, El Paso, Texas, USA., Walter Reed National Military Medical Center, Bethesda, Maryland, USA., Madigan Army Medical Center, Joint Base Lewis McChord, Washington, USA., Tripler Army Medical Center, Honolulu, Hawaii, USA., Fort Belvoir Community Hospital, Fort Belvoir, Virginia, USA., Carl R. Darnall Army Medical Center, Fort Hood, Texas, USA., Clinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.,
    1. Year: 2021
    2. Date: Oct 8
    3. Epub Date: 2021 10 08
  2. Journal: Open Forum Infectious Diseases
    1. 8
    2. 12
    3. Pages: ofab517
  4. Type of Article: Article
  5. Article Number: ofab517
  6. ISSN: 2328-8957
  1. Abstract:

    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). 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). 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. 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. Published by Oxford University Press on behalf of Infectious Diseases Society of America 2021.

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External Sources

  1. View Full Text
  2. DOI: 10.1093/ofid/ofab517
  3. PMID: 34901299
  4. PMCID: PMC8661080
  5. View record in Web of Science®
  6. WOS: 000744962900016
  7. PII : ofab517

Library Notes

  1. Fiscal Year: FY2021-2022
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