ArticleBMC infectious diseases2016
Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza.
Article in BMC infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 60 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Observational Study for the Identification of Relevant Variables Related to Health Status, Disability and Quality in Different Populations, Through the Analysis of Health Determinants and Paremeters Obtained by Means of Patient-reported Outcomes Questionnaires.
A Pilot Study of the Effects of Pre-Existing Immunity on Influenza A/Texas/71/2017 (H3N2) Virus Shedding After Human Challenge in Healthy Participants
Who cites it
60 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Raising the patient's voice in influenza research and care: a systematic review of patient-reported outcomes.BMC infectious diseases · 2026Pooled it
- Pooled 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
- The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus-associated disease in breakthrough infections in adults ≥60 years of age.Influenza and other respiratory viruses · 2024Trial
- Characterizing health-related quality of life and identifying disease predictors among patients suspected of having long COVID: an analysis of COMET-ICE clinical trial data.Frontiers in public health · 2024Trial
- Trial
- Randomized clinical trial of nitazoxanide or sofosbuvir/daclatasvir for the prevention of SARS-CoV-2 infection.The Journal of antimicrobial chemotherapy · 2022Trial
- Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine.Frontiers in immunology · 2022Trial
- Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Trial
- An Adjuvanted, Postfusion F Protein-Based Vaccine Did Not Prevent Respiratory Syncytial Virus Illness in Older Adults.The Journal of infectious diseases · 2017Trial
- Oseltamivir, amantadine, and ribavirin combination antiviral therapy versus oseltamivir monotherapy for the treatment of influenza: a multicentre, double-blind, randomised phase 2 trial.The Lancet. Infectious diseases · 2017Trial
- Estimating the Range and Duration of Post-influenza Symptoms, Conditions, and Diseases.Open forum infectious diseases · 2026Article
- Disease burden associated with influenza activity at the population level.Epidemiology and infection · 2026Article
- Influenza-like illness in cigarette smokers and electronic-cigarette users: a secondary analysis from the PAIVED study.Frontiers in public health · 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
- Controlled human influenza infection reveals heterogeneous expulsion of infectious virus into air.medRxiv : the preprint server for health sciences · 2025Article
- Effect of Influenza Vaccination on the Disease Severity and Viral Load Among Adult Outpatients and Inpatients.Vaccines · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors.
Funding
Abstract
backgroundTo develop content validity of a comprehensive patient-reported outcome (PRO) measure following current best scientific methodology to standardize assessment of influenza (flu) symptoms in clinical research.
methodsStage I (Concept Elicitation): 1:1 telephone interviews with influenza-positive adults (≥18 years) in the US and Mexico within 7 days of diagnosis. Participants described symptom type, character, severity, and duration. Content analysis identified themes and developed the draft Flu-PRO instrument. Stage II (Cognitive Interviewing): The Flu-PRO was administered to a unique set of influenza-positive adults within 14 days of diagnosis; telephone interviews addressed completeness, respondent interpretation of items and ease of use.
resultsSamples: Stage I: N = 46 adults (16 US, 30 Mexico); mean (SD) age: 38 (19), 39 (14) years; % female: 56%, 73%; race: 69% White, 97% Mestizo. Stage II: N = 34 adults (12 US, 22 Mexico); age: 37 (14), 39 (11) years; % female: 50%, 50%; race: 58% White, 100% Mestizo. SYMPTOMS: Symptoms identified by >50%: coughing, weak or tired, throat symptoms, congestion, headache, weakness, sweating, chills, general discomfort, runny nose, chest (trouble breathing), difficulty sleeping, and body aches or pains. No new content was uncovered during Stage II; participants easily understood the instrument.
conclusionsResults show the 37-item Flu-PRO is a content valid measure of influenza symptoms in adults with a confirmed diagnosis of influenza. Research is underway to evaluate the suitability of the instrument for children and adolescents. This work can form the basis for future quantitative tests of reliability, validity, and responsiveness to evaluate the measurement properties of Flu-PRO for use in clinical trials and epidemiology studies.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.