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

tetano

Editor, Senior Moderator
Value Health. 2018 Feb;21(2):210-218. doi: 10.1016/j.jval.2017.04.014. Epub 2017 Jun 7.
[h=1]Reliability, Validity, and Responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO?) Scores in Influenza-Positive Patients.[/h] Powers JH 3rd[SUP]1[/SUP], Bacci ED[SUP]2[/SUP], Guerrero ML[SUP]3[/SUP], Leidy NK[SUP]4[/SUP], Stringer S[SUP]4[/SUP], Kim K[SUP]4[/SUP], Memoli MJ[SUP]5[/SUP], Han A[SUP]5[/SUP], Fairchok MP[SUP]6[/SUP], Chen WJ[SUP]7[/SUP], Arnold JC[SUP]8[/SUP], Danaher PJ[SUP]9[/SUP], Lalani T[SUP]10[/SUP], Ridor? M[SUP]11[/SUP], Burgess TH[SUP]12[/SUP], Millar EV[SUP]7[/SUP], Hern?ndez A[SUP]13[/SUP], Rodr?guez-Zulueta P[SUP]14[/SUP], Smolskis MC[SUP]4[/SUP], Ortega-Gallegos H[SUP]3[/SUP], Pett S[SUP]15[/SUP], Fischer W[SUP]16[/SUP], Gillor D[SUP]17[/SUP], Macias LM[SUP]18[/SUP], DuVal A[SUP]19[/SUP], Rothman R[SUP]19[/SUP], Dugas A[SUP]19[/SUP], Ruiz-Palacios GM[SUP]3[/SUP].
[h=3]Author information[/h]

[h=3]Abstract[/h] [h=4]OBJECTIVES:[/h] To assess the reliability, validity, and responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO?) scores for quantifying the presence and severity of influenza symptoms.
[h=4]METHODS:[/h] 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 α 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.
[h=4]RESULTS:[/h] 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 α 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.
[h=4]CONCLUSIONS:[/h] 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.


[h=4]KEYWORDS:[/h] influenza; patient-reported outcome; psychometric; reliability; responsiveness; validity

PMID: 29477403 DOI: 10.1016/j.jval.2017.04.014
 
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