FLU-PRO
The FLU-PRO© is a self-administered patient-reported outcome measure (PRO) to quantify symptom severity in influenza and influenza-like illness. The instrument was developed by a team of academic investigators spanning multiple sites across many countries under the direction of Dr. John H. Powers of George Washington University and the University of Maryland, with the assistance of the patient-centered research staff of the PPD™ clinical research business of Thermo Fisher Scientific. Copyright, licensing and oversight of the FLU-PRO are managed by Leidos Biomedical Research. Information on the FLU-PRO is provided as a public service.
It was developed using qualitative and quantitative methods consistent with scientific measurement standards and U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines for clinical outcome assessments.
The FLU-PRO can be completed by patients using paper/pen, electronically (e-PRO) or via telephone interview. It has been tested and used in studies of influenza, influenza-like illness (ILI), respiratory syncytial virus (RSV), rhinovirus and enterovirus.
To date, the FLU-PRO has been completed by more than 4,000 patients between 12-81 years of age with adherence rates over 90%.
Content and structure
The FLU-PRO is a 32-item instrument that assesses severity of symptoms of influenza and influenza-like illness across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic.
Nine additional questions, such as global assessments of severity and change, can be used to facilitate data analyses. An additional two items can be added to assess changes in taste or smell if the instrument is used to quantify symptoms in studies of COVID-19.
Using the 24-hour recall period, patients/participants can complete the FLU-PRO daily or periodically, e.g., during weekly and/or clinic visits. Each question is brief (sign or symptom only with severity rating), and the entire questionnaire takes under four minutes to complete.
FLU-PRO scoring includes total and subscale scores for symptom severity by body system. The instrument also provides data on the presence/absence of symptoms, symptom profiles and change over time.
Investigator and licensing information
John H. Powers, MD, FACP, FIDSA, Professor of Clinical Medicine, George Washington University School of Medicine and University of Maryland School of Medicine, served as principal investigator of the FLU-PRO development project.
Our scientists served as co-investigators and project managers during the development of the FLU-PRO and can assist and advise on its use in clinical research.
Leidos Biomedical Research holds the copyright to the instrument and manages all licensing and use agreements.
Translations available
Translations are currently available in the following languages:
| Language |
|---|
| English |
| Dutch |
| French |
| Italian |
| Korean |
| Romanian |
| Russian |
| Spanish (for use in US, Mexico, and Spain) |
| Swedish |
Publications
Yu J, Powers JH 3rd, Vallo D, Falloon J. Evaluation of Efficacy Endpoints for a Phase IIb Study of a Respiratory Syncytial Virus Vaccine in Older Adults Using Patient-Reported Outcomes with Laboratory Confirmation. Value Health. 2020 Feb;23(2):227-235. doi: 10.1016/j.jval.2019.09.2747. Epub 2019 Nov 21.
Han A, Poon JL, Powers JH 3rd, Leidy NK, Yu R, Memoli MJ. Using the Influenza Patient-reported Outcome (FLU-PRO) Diary to Evaluate Symptoms of Influenza Viral Infection in a Healthy Human Challenge Model. BMC Infect Dis. 2018 Jul 28;18(1):353. doi: 10.1186/s12879-018-3220-8.
Powers JH, Bacci ED, Leidy NK, Poon JL, Stringer S, Memoli MJ, et al. Performance of the inFLUenza Patient-Reported Outcome (FLU-PRO) Diary in Patients with Influenza-Like Illness (ILI). PLoS One. 2018 Mar 22;13(3):e0194180. doi: 10.1371/journal.pone.0194180. eCollection 2018.
Powers JH, Bacci ED, Guerrero ML, Leidy NK, Stringer S, Kim K, Memoli MJ, et al. Reliability, Validity, and Responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO©) Scores in Influenza-Positive Patients. Value Health. 2018 Feb;21(2):210-218. doi: 10.1016/j.jval.2017.04.014. Epub 2017 Jun 7.
Powers JH, Guerrero ML, Leidy NK, Fairchok MP, Rosenberg A, Hernández A, Stringer S, Schofield C, Rodríguez-Zulueta P, Kim K, Danaher PJ, Ortega-Gallegos H, Bacci ED, Stepp N, et al. Development of the Flu-PRO: a Patient-Reported Outcome (PRO) Instrument to Evaluate Symptoms of Influenza. BMC Infect Dis. 2016 Jan 5;16(1):1. doi: 10.1186/s12879-015-1330-0.