902. Development of the Patient-Reported Outcome (PRO) Instrument FLU-PRO to Standardize and Quantify Symptoms of Influenza
Session: Poster Abstract Session: Respiratory Infections
Friday, October 4, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • FLU PRO Poster 6x4 IDSA FINAL_9-24-2013.pdf (1.8 MB)
  • Background: Develop content validity for a PRO instrument to standardize assessment of influenza (FLU) symptoms in clinical studies.   Currently there is no standardized, validated measure to evaluate influenza symptoms.

    Methods: A 2-stage instrument-development approach .   Stage I (Concept Elicitation):  Trained researchers conducted telephone interviews with influenza-positive adults >18 years old recruited in the US and Mexico within 7 days of diagnosis.  Participants described the character, severity, and duration of their symptoms.   An iterative process was used to analyze these qualitative data to draft the FLU-PRO instrument (items, response options, recall period, instructions).  Stage II (Cognitive Interviewing):  The draft instrument was administered via telephone to a unique set of influenza-positive adults in the U.S. and Mexico within 14 days of a clinic visit to evaluate respondent interpretation of the items and ease of use.

    Results: Samples:  Stage I:  N=46 Adults (16 US; 30 Mexico); US: Mean (SD) age = 38 (19) years; 56% female; 69% White, 19% Native American, 13% African American, 13% Asian. Mexico:  Mean (SD) age = 39.0 (13.5); 73% female; 97% Mestizo.   Stage II: N=28 Adults (12 US; 16 Mexico); US: Mean (SD) age = 37 (14) years; 50% female; 58% White, 33% African American, 8% Asian; 8% Hispanic. Mexico: Mean (SD) age = 40 (10) years; 56% female;  94% Mestizo.  Symptoms:  Stage 1 participants described 37 different upper and lower respiratory, gastrointestinal, and systemic symptoms.  The most common symptoms endorsed by >50% of the sample were coughing , weak or tired , sleeping more than usual, coughed up mucus or phlegm, and body aches or pains.  Other symptoms included runny or dripping nose, sneezing, chest congestion, dry or hacking cough , headache , difficulty falling asleep , general discomfort , chest tightness , sinus pressure , and sweating. Stage 2 showed understandability of the instrument.

    Conclusion: Concept elicitation and cognitive debriefing showed content validity for the 37-item FLU-PRO, a comprehensive instrument measuring influenza symptoms in adults. Research is underway examining suitability of the instrument for children/adolescents.  Quantitative tests of reliability, validity, and responsiveness are planned prior to use of FLU-PRO in clinical trials and epidemiology studies.

    John H. Powers III, MD, FIDSA1, Sonja Stringer, MPH2, Sarah Clifford, PhD2, Katherine Kim, MPH2, John Arnold, MD3, Christina Schofield, MD FACP4, Patrick Danaher, MD5, Karl Kronmann, MD, MPH6, Mary Fairchok, MD7, Michael Rajnik, MD8, Erin McDonough, BS9, Deepika Mor, MS10, M Lourdes Guerrero, MD11, Guillermo Ruiz-Palacios, MD11, Andrés Hernández, MD, MS11, Patricia Rodriguez Zulueta11, Arturo Galindo-Fraga, MD, MS11, Nancy Kline Leidy, PhD2, Eugene Millar, PhD12, Timothy Burgess, MD, MPH8, Michelande Ridore, BA13 and Mark Kortepeter, MD, MPH7, (1)Saic-Frederick Inc., National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, (2)United BioSource Corporation, Bethesda, MD, (3)Department of Pediatrics, Naval Medical Center San Diego, San Diego, CA, (4)Madigan Army Medical Center, Tacoma, WA, (5)San Antonio Military Health System, Fort Sam Houston, TX, (6)Naval Medical Center Portsmouth, Portsmouth, VA, (7)Infectious Disease Clinical Research Program, Tacoma, WA, (8)Walter Reed National Military Medical Center, Bethesda, MD, (9)Naval Health Research Center, San Diego, CA, (10)Data Coordination Center, Infectious Disease Clinical Research Program, Rockville, MD, (11)LaRed Network, Mexico City, Mexico, (12)Infectious Disease Clinical Research Program (IDCRP), Uniformed Services University of the Health Sciences (USU), Rockville, MD, (13)Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD

    Disclosures:

    J. H. Powers III, None

    S. Stringer, United BioSource Corporation: Employee, Salary and UBC provides consulting and other research services to pharmaceutical, device, government and non-government organizations. Ms. Stringer receives no payment or honoraria directly from these orgs

    S. Clifford, United BioSource Corporation: Employee, Salary and UBC provides consulting and other research services to pharmaceutical, device, government and non-government organizations. Dr. Clifford receives no payment or honoraria directly from these organizations.

    K. Kim, United BioSource Corporation: Employee, Salary and UBC provides consulting and other research services to pharmaceutical, device, government and non-government organizations. Ms. Kim receives no payment or honoraria directly from these organizations.

    J. Arnold, None

    C. Schofield, None

    P. Danaher, None

    K. Kronmann, None

    M. Fairchok, None

    M. Rajnik, None

    E. McDonough, None

    D. Mor, None

    M. L. Guerrero, None

    G. Ruiz-Palacios, None

    A. Hernández, None

    P. R. Zulueta, None

    A. Galindo-Fraga, None

    N. K. Leidy, United BioSource Corporation: Employee, Salary and UBC provides consulting and other research services to pharmaceutical, device, government and non-government organizations. Dr. Leidy receives no payment or honoraria directly from these organizations.

    E. Millar, None

    T. Burgess, None

    M. Ridore, None

    M. Kortepeter, None

    Findings in the abstracts are embargoed until 12:01 a.m. PST, Oct. 2nd with the exception of research findings presented at the IDWeek press conferences.