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BMC Infect Dis. 2016 Jan 5;16(1):1. doi: 10.1186/s12879-015-1330-0.
Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza.
Powers JH1,2, Guerrero ML3, Leidy NK4, Fairchok MP5,6,7, Rosenberg A8, Hern?ndez A9, Stringer S10, Schofield C11, Rodr?guez-Zulueta P12, Kim K13, Danaher PJ14, Ortega-Gallegos H15, Bacci ED16, Stepp N17, Galindo-Fraga A18, Clair KS19, Rajnik M20, McDonough EA21, Ridor? M22,23, Arnold JC24, Millar EV25,26, Ruiz-Palacios GM27.
Author information
Abstract
BACKGROUND:
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.
METHODS:
Stage 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.
RESULTS:
SAMPLES:
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.
CONCLUSIONS:
Results 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.
PMID: 26729246 [PubMed - in process] PMCID: PMC4700740 Free PMC Article
Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza.
Powers JH1,2, Guerrero ML3, Leidy NK4, Fairchok MP5,6,7, Rosenberg A8, Hern?ndez A9, Stringer S10, Schofield C11, Rodr?guez-Zulueta P12, Kim K13, Danaher PJ14, Ortega-Gallegos H15, Bacci ED16, Stepp N17, Galindo-Fraga A18, Clair KS19, Rajnik M20, McDonough EA21, Ridor? M22,23, Arnold JC24, Millar EV25,26, Ruiz-Palacios GM27.
Author information
Abstract
BACKGROUND:
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.
METHODS:
Stage 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.
RESULTS:
SAMPLES:
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.
CONCLUSIONS:
Results 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.
PMID: 26729246 [PubMed - in process] PMCID: PMC4700740 Free PMC Article