Reliability, Validity, and Responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO©) Scores in...

Area of Science:

• Clinical research
• Health outcomes assessment
• Influenza epidemiology

Background:

• Influenza symptom assessment often relies on subjective patient reports.
• A validated, reliable, and responsive patient-reported outcome measure is crucial for clinical trials and patient management.
• The InFLUenza Patient-Reported Outcome (FLU-PRO) tool was developed to address this need.

Purpose of the Study:

• To evaluate the reliability, validity, and responsiveness of the InFLUenza Patient-Reported Outcome (FLU-PRO) tool.
• To quantify the presence and severity of influenza symptoms using patient-reported outcomes.

Main Methods:

• An observational prospective cohort study involving 221 influenza-positive adults across multiple countries.
• Participants completed the 32-item FLU-PRO daily for up to 14 days.
• Statistical analyses included item-level and factor analyses, reliability testing (Cronbach α, ICC), and validity/responsiveness assessments using global ratings.

Main Results:

• The final 32-item FLU-PRO demonstrated strong reliability (Cronbach α = 0.92, test-retest ICC = 0.83).
• The measure showed good convergent and known-groups validity, correlating with global severity ratings and differentiating between severity groups.
• FLU-PRO scores were responsive to changes in health status, indicating clinical utility.

Conclusions:

• The InFLUenza Patient-Reported Outcome (FLU-PRO) scores are reliable, valid, and responsive in adults with influenza.
• The FLU-PRO tool is suitable for quantifying influenza symptom presence and severity in clinical research and practice.