TY - JOUR
T1 - Performance of the inFLUenza Patient-Reported Outcome (FLU-PRO) diary in patients with influenza-like illness (ILI)
AU - Powers, John H.
AU - Bacci, Elizabeth D.
AU - Leidy, Nancy K.
AU - Poon, Jiat Ling
AU - Stringer, Sonja
AU - Memoli, Matthew J.
AU - Han, Alison
AU - Fairchok, Mary P.
AU - Coles, Christian
AU - Owens, Jackie
AU - Chen, Wei Ju
AU - Arnold, John C.
AU - Danaher, Patrick J.
AU - Lalani, Tahaniyat
AU - Burgess, Timothy H.
AU - Millar, Eugene V.
AU - Ridore, Michelande
AU - Hernández, Andrés
AU - Rodríguez-Zulueta, Patricia
AU - Ortega-Gallegos, Hilda
AU - Galindo-Fraga, Arturo
AU - Ruiz-Palacios, Guillermo M.
AU - Pett, Sarah
AU - Fischer, William
AU - Gillor, Daniel
AU - Macias, Laura Moreno
AU - DuVal, Anna
AU - Rothman, Richard
AU - Dugas, Andrea
AU - Guerrero, M. Lourdes
N1 - Publisher Copyright:
This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.
PY - 2018/3
Y1 - 2018/3
N2 - 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<0.001; subscales: F = 6.9–62.2; p<0.01). Mean score improvements Day 1–7 were significantly greater in patients reporting return to usual health compared with those who did not (p<0.05, Total and subscales, except Gastrointestinal and Eyes). Conclusions Results suggest FLU-PRO scores are reliable, valid, and responsive in adults with influenza-like illness.
AB - 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<0.001; subscales: F = 6.9–62.2; p<0.01). Mean score improvements Day 1–7 were significantly greater in patients reporting return to usual health compared with those who did not (p<0.05, Total and subscales, except Gastrointestinal and Eyes). Conclusions Results suggest FLU-PRO scores are reliable, valid, and responsive in adults with influenza-like illness.
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U2 - 10.1371/journal.pone.0194180
DO - 10.1371/journal.pone.0194180
M3 - Article
C2 - 29566007
AN - SCOPUS:85044351287
SN - 1932-6203
VL - 13
JO - PloS one
JF - PloS one
IS - 3
M1 - e0194180
ER -