TY - JOUR
T1 - Development of the Flu-PRO
T2 - A patient-reported outcome (PRO) instrument to evaluate symptoms of influenza
AU - Powers, John H.
AU - Guerrero, M. Lourdes
AU - Leidy, Nancy Kline
AU - Fairchok, Mary P.
AU - Rosenberg, Alice
AU - Hernández, Andrés
AU - Stringer, Sonja
AU - Schofield, Christina
AU - Rodríguez-Zulueta, Patricia
AU - Kim, Katherine
AU - Danaher, Patrick J.
AU - Ortega-Gallegos, Hilda
AU - Bacci, Elizabeth Dansie
AU - Stepp, Nathaniel
AU - Galindo-Fraga, Arturo
AU - Clair, Kristina St
AU - Rajnik, Michael
AU - McDonough, Erin A.
AU - Ridoré, Michelande
AU - Arnold, John C.
AU - Millar, Eugene V.
AU - Ruiz-Palacios, Guillermo M.
N1 - Publisher Copyright:
© 2015 Powers et al.
PY - 2016/1/5
Y1 - 2016/1/5
N2 - 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.
AB - 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.
KW - Content validity
KW - Endpoints
KW - Influenza
KW - Outcome assessments
KW - Patient-reported outcomes
KW - Symptoms
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U2 - 10.1186/s12879-015-1330-0
DO - 10.1186/s12879-015-1330-0
M3 - Article
C2 - 26729246
AN - SCOPUS:84959092162
SN - 1471-2334
VL - 16
JO - BMC infectious diseases
JF - BMC infectious diseases
IS - 1
M1 - 1
ER -