Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019
Author(s) -
Stephanie A Richard,
Nusrat J Epsi,
Simon Pollett,
David A Lindholm,
Allison M.W. Malloy,
Ryan C. Maves,
Gregory Utz,
Tahaniyat Lalani,
Alfred G. Smith,
Rupal Mody,
Anuradha Ganesan,
Rhonda E Colombo,
Christopher Colombo,
Wormi Sharon,
Nikhil Huprikar,
Derek Larson,
Samantha Bazan,
Cristian Madar,
Charlotte Lanteri,
Julia S Rozman,
Caroline English,
Katrin Mende,
David R. Tribble,
Brian K. Agan,
Timothy Burgess,
John H. Powers,
John D. Cowden,
Michele Darling,
T. Allen Merritt,
T Wellington,
Ann Rutt,
S Chambers,
W Robb-McGrath,
Catherine M Berjohn,
N Kirkland,
Christopher C. Broder,
Celia Byrne,
M Fritschlanski,
Peter Hickey,
Eric D. Laing,
Jeffrey Livezey,
Edward Parmelee,
Jennifer A. Rusiecki,
I Scher,
B. Barton,
David C. Hostler,
Jordanna Hostler,
Kathryn Lago,
Carlos J Maldonado,
M. Wayman,
Stephanie DeLeon,
Ana E Markelz,
S Merritt,
Nicholas Turner,
Robert A. Darnall,
S Bazan,
Paula Love,
N Dimascio-Johnson,
Evan Ewers,
K Gallagher,
Paul W. Blair,
Josh Chenoweth,
DesRaj M. Clark,
Christopher P. Conlon,
K Everson,
P Faestel,
Tanya M. Ferguson,
L Gordon,
Sarah Grogan,
S. Bertrán de Lis,
C Mount,
D Musfeldt,
D Odineal,
MM Perreault,
Rebecca Sainato,
Carin Schofield,
Caroline Skinner,
Michal Stein,
Mary E. Switzer,
M Timlin,
Stephen A. Wood,
Sarah J. Banks,
R Carpenter,
L Kim,
Karl Kronmann,
Teresa Lee,
Adrian D. Smith,
Richard V. Smith,
R. Tant,
Tyler Warkentien,
S. Cammarata,
Sharon Chi,
Ryan Flanagan,
Matthew Jones,
Christelle Lucas,
K Miyasato,
Catherine Uyehara,
L Andronescu,
AmaezeA Austin,
Kevin K. Chung,
Jeff Davies,
C English,
Charlie Fox,
M Grother,
A Hadley,
Rasha N. Mohammed,
Carlos Morales,
P Nwachukwu,
Cara Olsen,
E Samuels,
Marta García Sánchez,
Mark P. Simons,
Andrew L. Snow,
Kalyani Telu,
L Ulomi,
Tiffany N. Chao,
Richard R. Chapleau,
Anthony C Fries,
Caitlin Harrington,
Shana Huntsberger,
Sherrill Purves,
K Reynolds,
José Ángel Rodríguez,
Clarise Starr,
J Mehrer,
T Hunter,
Juan M. Mejia,
Roy G. Resendez,
P. Rodrigo Sandoval,
Igor Barahona,
Aziza Baya Baya,
Brian Johnson,
Sheila A. Peel
Publication year - 2021
Publication title -
open forum infectious diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.546
H-Index - 35
ISSN - 2328-8957
DOI - 10.1093/ofid/ofab517
Subject(s) - medicine , intraclass correlation , construct validity , severity of illness , prospective cohort study , cohort , disease , physical therapy , psychometrics , surgery , patient satisfaction , clinical psychology
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.
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