Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019
Author:
Richard Stephanie A12ORCID, Epsi Nusrat J12, Pollett Simon12, Lindholm David A34, Malloy Allison M W4, Maves Ryan15, Utz Gregory C125, Lalani Tahaniyat126ORCID, Smith Alfred G6, Mody Rupal M7, Ganesan Anuradha128, Colombo Rhonda E129, Colombo Christopher J49, Chi Sharon W1210, Huprikar Nikhil48, Larson Derek T411, Bazan Samantha12, Madar Cristian10, Lanteri Charlotte1, Rozman Julia S12, English Caroline12, Mende Katrin123, Tribble David R1, Agan Brian K12ORCID, Burgess Timothy H1, Powers John H13, Cowden J, Darling M, Merritt T, Wellington T, Rutt A, Chambers S, Robb-McGrath W, Berjohn C, Kirkland N, Broder C, Byrne C, Fritschlanski M, Hickey P, Laing E, Livezey J, Parmelee E, Rusiecki J, Scher A, Barton B, Hostler D, Hostler J, Lago K, Maldonado C, Wayman M, DeLeon S, Lindholm D, Markelz A, Mende K, Merritt S, Turner N, Darnall R, Bazan S, K Love P, Dimascio-Johnson N, Ewers E, Gallagher K, Larson D, Blair P, Chenoweth J, Clark D, J Colombo C, Colombo R, Conlon C, Everson K, Faestel P, Ferguson T, Gordon L, Grogan S, Lis S, Mount C, Musfeldt D, Odineal D, Perreault M, Sainato R, Schofield C, Skinner C, Stein M, Switzer M, Timlin M, Wood S, Banks S, Carpenter R, Kim L, Kronmann K, Lalani T, Lee T, Smith A, Smith R, Tant R, Warkentien T, Cammarata S, Maves R, Utz G, Chi S, Flanagan R, Jones M, Lucas C, Madar C, Miyasato K, Uyehara C, Agan B, Andronescu L, Austin A, Burgess T, Chung K, Davies J, English C, Epsi N, Fox C, Grother M, Hadley A, Lanteri C, Malloy A, Mohammed R, Morales C, Nwachukwu P, Olsen C, Pollett S, Richard S, Rozman J, Samuels E, Sanchez M, Simons M, Snow A, Telu K, Tribble D, Ulomi L, Chao T, Chapleau R, Fries A, Harrington C, Huntsberger S, Purves S, Reynolds K, Rodriguez J, Starr C, Mehrer J, Hunter T, Mejia J, Mody R, Resendez R, Sandoval P, Barahona I, Baya A, Ganesan A, Huprikar N, Johnson B, Peel S,
Affiliation:
1. Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA 2. The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, Maryland, USA 3. Brooke Army Medical Center, Fort Sam Houston, Texas, USA 4. Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA 5. Naval Medical Center San Diego, San Diego, California, USA 6. Naval Medical Center Portsmouth, Portsmouth, Virginia, USA 7. William Beaumont Army Medical Center, El Paso, Texas, USA 8. Walter Reed National Military Medical Center, Bethesda, Maryland, USA 9. Madigan Army Medical Center, Joint Base Lewis McChord, Washington, USA 10. Tripler Army Medical Center, Honolulu, Hawaii, USA 11. Fort Belvoir Community Hospital, Fort Belvoir, Virginia, USA 12. Carl R. Darnall Army Medical Center, Fort Hood, Texas, USA 13. Clinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA
Abstract
Abstract
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.
Funder
Defense Health Program National Institute of Allergy and Infectious Diseases National Institutes of Health National Cancer Institute
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Oncology
Cited by
18 articles.
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