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Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019.
Richard, Stephanie A; Epsi, Nusrat J; Pollett, Simon; Lindholm, David A; Malloy, Allison M W; Maves, Ryan; Utz, Gregory C; Lalani, Tahaniyat; 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; Burgess, Timothy H; Powers, John H.
  • Richard SA; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • Epsi NJ; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, Maryland, USA.
  • Pollett S; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • Lindholm DA; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, Maryland, USA.
  • Malloy AMW; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • Maves R; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, Maryland, USA.
  • Utz GC; Brooke Army Medical Center, Fort Sam Houston, Texas, USA.
  • Lalani T; Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • Smith AG; Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • Mody RM; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • Ganesan A; Naval Medical Center San Diego, San Diego, California, USA.
  • Colombo RE; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • Colombo CJ; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, Maryland, USA.
  • Chi SW; Naval Medical Center San Diego, San Diego, California, USA.
  • Huprikar N; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • Larson DT; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, Maryland, USA.
  • Bazan S; Naval Medical Center Portsmouth, Portsmouth, Virginia, USA.
  • Madar C; Naval Medical Center Portsmouth, Portsmouth, Virginia, USA.
  • Lanteri C; William Beaumont Army Medical Center, El Paso, Texas, USA.
  • Rozman JS; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • English C; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, Maryland, USA.
  • Mende K; Walter Reed National Military Medical Center, Bethesda, Maryland, USA.
  • Tribble DR; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • Agan BK; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, Maryland, USA.
  • Burgess TH; Madigan Army Medical Center, Joint Base Lewis McChord, Washington, USA.
  • Powers JH; Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
Open Forum Infect Dis ; 8(12): ofab517, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1570092
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

Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews Topics: Vaccines Language: English Journal: Open Forum Infect Dis Year: 2021 Document Type: Article Affiliation country: Ofid

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews Topics: Vaccines Language: English Journal: Open Forum Infect Dis Year: 2021 Document Type: Article Affiliation country: Ofid