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.
Highlights
To develop content validity of a comprehensive patient-reported outcome (PRO) measure following current best scientific methodology to standardize assessment of influenza symptoms in clinical research
The purpose of this study was to begin to develop a PRO instrument to standardize the assessment of influenza (Flu) symptoms, the Flu-PRO, by evaluating content validity using methods recommended by the United States (US) Food and Drug Administration (FDA) [6] and good research practices [7, 8]
Patients with laboratory-confirmed influenza were recruited from military treatment facilities or associated clinics in the US, and the Mexico Emerging Infectious Diseases Clinical Research Network (LaRed) in Mexico, which consisted of three hospitals: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (Nutricion), Instituto Nacional de Enfermedades Respiratorias (INER), and Hospital General Dr Manuel Gea
Summary
To 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. Worldwide influenza and its complications result in an estimated 3–5 million cases of severe illness and approximately 250,000–500,000 deaths every year [5]. There is no standardized, validated patientreported outcome (PRO) measure for influenza and influenza-like symptoms developed according to accepted scientific standards [6,7,8]. Combined with other baseline variables, quantification of symptoms would help define and standardize severity of illness measures for influenza. A validated measure could be used to standardize and document the presence and severity of symptoms in patients who develop the disease. A standardized tool across studies would facilitate meta-analyses and comparisons of interventions
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
