Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019

Abstract

Background The FLU-PRO Plus is a patient-reported outcome data collection instrument assessing symptoms of viral respiratory tract infections across eight body systems. This study evaluated the measurement properties of FLU-PRO Plus in a study enrolling individuals with COVID-19. Methods Data from a prospective cohort study (EPICC) in US Military Health System (MHS) beneficiaries evaluated for COVID-19 was utilized. Adults with symptomatic SARS-CoV-2 infection with FLU-PRO Plus survey information within one week of symptom onset were included. Reliability of FLU-PRO Plus was estimated using intraclass correlation coefficients (ICC; 2 days reproducibility). Known-groups validity was assessed using patient global assessments (PGA) of disease severity. Patient report of return to usual health was used to assess responsiveness (day 1-6/7). Results 226 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 (e.g., 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.

Systematic surveillance of patient-reported symptoms of viral respiratory tract infectious Syndromes in diverse populations

“…Viral respiratory illnesses are common, although the symptoms, symptom intensity, and symptom duration can vary across illnesses [28,31]. The onset of the novel coronavirus (COVID-19) brought about a variety of patient-reported surveys that individuals could use to report and track their symptoms [33][34][35][36]. FLU-PRO© is a validated PROM originally developed to standardize capture of patients' symptoms associated with influenza, respiratory syncytial virus, rhinovirus, enterovirus, and endemic coronaviruses throughout a 14-day course, or until symptoms subside and participants return to their baseline health [28,31].…”

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of ThymoQuinone Formula (TQF) for Treating Outpatient SARS-CoV-2

“…Symptom burdens not significant at 0.007 were Chest/Respiratory ( p = 0.024), Gastrointestinal ( p = 0.124), and Smell/Taste ( p = 0.032) domains, although they declined suggestively much faster with TQF therapy. FLU-PRO plus is a reliable self-administered SARS-CoV-2 symptom scoring system that has been validated and suggested as a tool to compare results from different studies of viral pulmonary infections [ 10 ]. Indeed, with the advent of multiple trials for SARS-CoV-2 therapeutics, patient-reported quality of life as a core outcome measure was recommended by the Global SARS-CoV-2 Core Outcomes Set (SARS-CoV-2 COS) initiative [ 10 ].…”

“…FLU-PRO plus is a reliable self-administered SARS-CoV-2 symptom scoring system that has been validated and suggested as a tool to compare results from different studies of viral pulmonary infections [ 10 ]. Indeed, with the advent of multiple trials for SARS-CoV-2 therapeutics, patient-reported quality of life as a core outcome measure was recommended by the Global SARS-CoV-2 Core Outcomes Set (SARS-CoV-2 COS) initiative [ 10 ]. Our paper validated the Modified FLU-PRO Plus questionnaire as a SARS-CoV-2 symptom tool as it focuses on what is clinically relevant to the patient.…”

Comparing Prospective Incident Severe Acute Respiratory Syndrome Coronavirus 2 Infection Rates During Successive Waves of Delta and Omicron in Johannesburg, South Africa

“…Weekly check-ins were conducted telephonically or using internet-based communication systems to assess for COVID-19–related symptoms. Secondary endpoints included symptoms assessed through FLU-PRO Plus (successfully used in other COVID-19 studies) [ 14–16 ]. Multiple, discrete occurrences of COVID-19 infection could be identified in a single participant.…”