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 - Funding Information:
This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under Contract No. HHSN261200800001E. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. This project was supported by the National Institutes of Allergy and Infectious Diseases. The views expressed are those of the author(s) and do not necessarily reflect the official views of the Uniformed Services University of the Health Sciences, the US Navy, the US Army, the US Air Force, or the US Department of Defense. JA, MR, NS, and PD are service members. This work was prepared as part of their official duties. Title 17 U.S.C. §105 provides that ‘Copyright protection under this title is not available for any work of the United States Government.’ Title 17 U.S.C. §101 defines a U.S. Government work as a work prepared by a military service member or employee of the U.S. Government as part of that person’s official duties. We would like to extend sincere appreciation to the Flu-PRO Study Group and the staff providing research support at the clinical sites and Louisa Wahala for her assistance with protocol development, research assistants for data entry, cleaning, and assistance with the analyses. We are grateful to the research participants for their time and willingness to engage in this research.
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
UR - http://www.scopus.com/inward/record.url?scp=84959092162&partnerID=8YFLogxK
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 -