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Reliability, Validity, and Responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO©) Scores in Influenza-Positive Patients

  1. Author:
    Powers, John
    Bacci, Elizabeth D
    Guerrero, M Lourdes
    Leidy, Nancy Kline
    Stringer, Sonja
    Kim, Katherine
    Memoli, Matthew J
    Han, Alison
    Fairchok, Mary P
    Chen, Wei-Ju
    Arnold, John C
    Danaher, Patrick J
    Lalani, Tahaniyat
    Ridoré, Michelande
    Burgess, Timothy H
    Millar, Eugene V
    Hernández, Andrés
    Rodríguez-Zulueta, Patricia
    Smolskis, Mary C
    Ortega-Gallegos, Hilda
    Pett, Sarah
    Fischer, William
    Gillor, Daniel
    Macias, Laura Moreno
    DuVal, Anna
    Rothman, Richard
    Dugas, Andrea
    Ruiz-Palacios, Guillermo M

  2. Author Address

    Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc., NCI Campus at Frederick, Frederick, MD, USA. Electronic address: john.powers@nih.gov., Evidera, Seattle, WA, USA., Instituto Nacional de Ciencias M 233;dicas y Nutrici 243;n Salvador Zubir 225;n, Mexico City, Mexico., Evidera, Bethesda, MD, USA., National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Madigan Army Medical Center, Fort Lewis, WA, USA; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, F. Edward H 233;bert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA., Naval Medical Center, San Diego, CA, USA., Defense Institute for Medical Operations, San Antonio, TX, USA., Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA; Naval Medical Center, Portsmouth, VA, USA., Children 39;s National Medical Center, Washington, DC, USA., Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, F. Edward H 233;bert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA; Walter Reed National Military Medical Center, Bethesda, MD, USA., Instituto Nacional de Enfermedades Respiratorias Ismael Cos 237;o Villegas, Mexico City, Mexico., Hospital General Dr. Manuel Gea Gonz 225;lez, Mexico City, Mexico., University College London, London, UK; Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia., University of North Carolina, Chapel Hill, NC, USA., Cologne, Germany., Hospital General de Agudos JM Ramos Mejia, Buenos Aires, Argentina., Johns Hopkins University School of Medicine, Baltimore, MD, USA (for the INSIGHT Flu 002 Plus Writing Group, the M 233;xico Emerging Infectious Diseases Clinical Research Network, and the Infectious Diseases Clinical Research Program).,
    1. Year: 2018
    2. Date: Feb
    3. Epub Date: 2017 06 07
  2. Journal: Value in Health
    1. 21
    2. 2
    3. Pages: 210-218
  4. Type of Article: Article
  1. Abstract:

    To assess the reliability, validity, and responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO©) scores for quantifying the presence and severity of influenza symptoms. An observational prospective cohort study of adults (=18 years) with influenza-like illness in the United States, the United Kingdom, Mexico, and South America was conducted. Participants completed the 37-item draft FLU-PRO daily for up to 14 days. Item-level and factor analyses were used to remove items and determine factor structure. Reliability of the final tool was estimated using Cronbach a and intraclass correlation coefficients (2-day reliability). Convergent and known-groups validity and responsiveness were assessed using global assessments of influenza severity and return to usual health. Of the 536 patients enrolled, 221 influenza-positive subjects comprised the analytical sample. The mean age of the patients was 40.7 years, 60.2% were women, and 59.7% were white. The final 32-item measure has six factors/domains (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic), with a higher order factor representing symptom severity overall (comparative fit index = 0.92; root mean square error of approximation = 0.06). Cronbach a was high (total = 0.92; domain range = 0.71-0.87); test-retest reliability (intraclass correlation coefficient, day 1-day 2) was 0.83 for total scores and 0.57 to 0.79 for domains. Day 1 FLU-PRO domain and total scores were moderately to highly correlated (=0.30) with Patient Global Rating of Flu Severity (except nose and throat). Consistent with known-groups validity, scores differentiated severity groups on the basis of global rating (total: F = 57.2, P < 0.001; domains: F = 8.9-67.5, P < 0.001). Subjects reporting return to usual health showed significantly greater (P < 0.05) FLU-PRO score improvement by day 7 than did those who did not, suggesting score responsiveness. Results suggest that FLU-PRO scores are reliable, valid, and responsive to change in influenza-positive adults. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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External Sources

  1. View Full Text
  2. DOI: 10.1016/j.jval.2017.04.014
  3. PMID: 29477403
  4. PMCID: PMC5831548
  5. View record in Web of Science®
  6. WOS: 000425894000017
  7. PII : S1098-3015(17)30214-0

Library Notes

  1. Fiscal Year: FY2017-2018
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