ArticleOpen forum infectious diseases2021
Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019.
Article in Open forum infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Remdesivir for the treatment of COVID-19.The Cochrane database of systematic reviews · 2023Pooled it
- Participant self-collected versus research coordinator-collected nasal swabs for respiratory viral surveillance following influenza-like illness.Frontiers in public health · 2026Trial
- Randomized Pragmatic Trial of the Comparative Effectiveness of Chicken Egg-Based Inactivated, Mammalian Cell Culture-Based Inactivated, and Recombinant Protein Quadrivalent Seasonal Influenza Vaccines in United States Military Health System Beneficiaries.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Relative Effectiveness and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Versus Egg-Based Inactivated Influenza Vaccine Among Adults Aged 18-64 Years: Results and Experience From a Randomized, Double-Blind Trial.Open forum infectious diseases · 2024Trial
- Artemether-lumefantrine versus pyronaridine-artesunate for the treatment of malaria in patients with mild to moderate COVID-19 in Kenya and Burkina Faso: a randomised open-label trial (MALCOV).EClinicalMedicine · 2026Article
- Healthcare Workers Have More Frequent and Less Severe Influenza-Like Illness Than Non-healthcare Workers: Findings From the PAIVED Study.Open forum infectious diseases · 2026Article
- Self-reported COVID-19 severity among persons with tuberculosis infection in western Kenya, 2021.PLOS global public health · 2025Article
- COVID-19 symptom severity and duration among outpatients, July 2021-May 2023: The PROTECT observational study.PloS one · 2025Observational
- Identifying central symptom clusters and correlates among post-COVID-19 pulmonary fibrosis patients: a network analysis.Frontiers in medicine · 2025Article
- Article
- Two-Year Longitudinal Study Reveals That Long COVID Symptoms Peak and Quality of Life Nadirs at 6-12 Months Postinfection.Open forum infectious diseases · 2024Article
- Characterizing Symptoms and Identifying Biomarkers of Long COVID in People With and Without HIV: Protocol for a Remotely Conducted Prospective Observational Cohort Study.JMIR research protocols · 2023Article
- Qualitative interviews to evaluate content validity of the ACTIV-2 COVID-19 Symptom Diary (ACSD).Journal of patient-reported outcomes · 2023Article
- Long COVID brain fog and muscle pain are associated with longer time to clearance of SARS-CoV-2 RNA from the upper respiratory tract during acute infection.Frontiers in immunology · 2023Article
- Article
- Comparing Prospective Incident Severe Acute Respiratory Syndrome Coronavirus 2 Infection Rates During Successive Waves of Delta and Omicron in Johannesburg, South Africa.Open forum infectious diseases · 2022Article
- Development of a novel patient-reported outcome measure to assess signs and symptoms of COVID-19.Journal of patient-reported outcomes · 2022Article
- COVID-19 Patient-Reported Symptoms Using FLU-PRO Plus in a Cohort Study: Associations With Infecting Genotype, Vaccine History, and Return to Health.Open forum infectious diseases · 2022Article
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of ThymoQuinone Formula (TQF) for Treating Outpatient SARS-CoV-2.Pathogens (Basel, Switzerland) · 2022Article
Corrections and comments
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Authors and funding
27 authors.
Funding
Abstract
backgroundThe 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).
methodsData 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).
resultsTwo 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.
conclusionsFLU-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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