Performance of the inFLUenza Patient-Reported Outcome (FLU-PRO) diary in patients with influenza-like illness (ILI)

John H Powers, Elizabeth D Bacci, Nancy K Leidy, Jiat-Ling Poon, Sonja Stringer, Matthew J Memoli, Alison Han, Mary P Fairchok, Christian Coles, Jackie Owens, Wei-Ju Chen, John C Arnold, Patrick J Danaher, Tahaniyat Lalani, Timothy H Burgess, Eugene V Millar, Michelande Ridore, Andrés Hernández, Patricia Rodríguez-Zulueta, Hilda Ortega-Gallegos, Arturo Galindo-Fraga, Guillermo M Ruiz-Palacios, Sarah Pett, William Fischer, Daniel Gillor, Laura Moreno Macias, Anna DuVal, Richard Rothman, Andrea Dugas and M Lourdes Guerrero

PLOS ONE, 2018, vol. 13, issue 3, 1-15

Abstract: Background: The inFLUenza Patient Reported Outcome (FLU-PRO) measure is a daily diary assessing signs/symptoms of influenza across six body systems: Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, Body/Systemic, developed and tested in adults with influenza. Objectives: This study tested the reliability, validity, and responsiveness of FLU-PRO scores in adults with influenza-like illness (ILI). Methods: Data from the prospective, observational study used to develop and test the FLU-PRO in influenza virus positive patients were analyzed. Adults (≥18 years) presenting with influenza symptoms in outpatient settings in the US, UK, Mexico, and South America were enrolled, tested for influenza virus, and asked to complete the 37-item draft FLU-PRO daily for up to 14-days. Analyses were performed on data from patients testing negative. Reliability of the final, 32-item FLU-PRO was estimated using Cronbach’s alpha (α; Day 1) and intraclass correlation coefficients (ICC; 2-day reproducibility). Convergent and known-groups validity were assessed using patient global assessments of influenza severity (PGA). Patient report of return to usual health was used to assess responsiveness (Day 1–7). Results: The analytical sample included 220 ILI patients (mean age = 39.3, 64.1% female, 88.6% white). Sixty-one (28%) were hospitalized at some point in their illness. Internal consistency reliability (α) of FLU-PRO Total score was 0.90 and ranged from 0.72–0.86 for domain scores. Reproducibility (Day 1–2) was 0.64 for Total, ranging from 0.46–0.78 for domain scores. Day 1 FLU-PRO scores correlated (≥0.30) with the PGA (except Gastrointestinal) and were significantly different across PGA severity groups (Total: F = 81.7, p

Date: 2018
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0194180

DOI: 10.1371/journal.pone.0194180

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