Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza. Issue 1 (December 2015)

• Record Type: Journal Article
• Authors: Powers, John; Guerrero, M.; Leidy, Nancy; Fairchok, Mary; Rosenberg, Alice; Hernández, Andrés; Stringer, Sonja; Schofield, Christina; Rodríguez-Zulueta, Patricia; Kim, Katherine; Danaher, Patrick; Ortega-Gallegos, Hilda; Bacci, Elizabeth; Stepp, Nathaniel; Galindo-Fraga, Arturo; Clair, Kristina; Rajnik, Michael; McDonough, Erin; Ridoré, Michelande; Arnold, John; Millar, Eugene; Ruiz-Palacios, Guillermo
• Is Part Of: BMC infectious diseases. Volume 16:Issue 1(2016)
• Page Start: 1
• Page End: 11
• Publication Date: 2015-12
• Subjects: Influenza -- Symptoms -- Patient-reported outcomes -- Endpoints -- Outcome assessments -- Content validity; Communicable diseases -- Periodicals; Sexually Transmitted Diseases -- Periodicals; 616.905
• DOI: 10.1186/s12879-015-1330-0
• Languages: English
• ISSNs: 1471-2334

Abstract

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.