Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza

被引：63

作者：

Powers, John H. ^{[1
,2
]}

Guerrero, M. Lourdes ^{[3
]}

Leidy, Nancy Kline ^{[4
]}

Fairchok, Mary P. ^{[5
,6
,7
]}

Rosenberg, Alice ^{[1
,2
]}

Hernandez, Andres ^{[8
]}

Stringer, Sonja ^{[4
]}

Schofield, Christina ^{[7
]}

Rodriguez-Zulueta, Patricia ^{[9
]}

Kim, Katherine ^{[4
]}

Danaher, Patrick J. ^{[10
]}

Ortega-Gallegos, Hilda ^{[3
]}

Bacci, Elizabeth Dansie ^{[4
]}

Stepp, Nathaniel ^{[11
]}

Galindo-Fraga, Arturo ^{[3
]}

St Clair, Kristina ^{[12
]}

Rajnik, Michael ^{[13
]}

McDonough, Erin A. ^{[14
]}

Ridore, Michelande ^{[5
,6
]}

Arnold, John C. ^{[15
]}

Millar, Eugene V. ^{[5
,6
]}

Ruiz-Palacios, Guillermo M. ^{[3
]}

机构：

[1] Leidos Biomed Res Inc, Clin Monitoring & Res Program, Clin Res Directorate, Frederick Natl Lab Canc Res, Frederick, MD 21702 USA

[2] NIAID, Collaborat Clin Res Branch, Div Clin Res, Bethesda, MD 20892 USA

[3] Inst Nacl Ciencias Med & Nutr Salvador Zubiran, Mexico City, DF, Mexico

[4] Evidera, Bethesda, MD USA

[5] Uniformed Serv Univ Hlth Sci, Infect Dis Clin Res Program, Bethesda, MD 20814 USA

[6] Henry M Jackson Fdn Adv Mil Med, Bethesda, MD USA

[7] Madigan Army Med Ctr, Tacoma, WA 98431 USA

[8] Inst Nacl Enfermedades Infecciosas, Mexico City, DF, Mexico

[9] Hosp Gen Dr Manuel Gea Gonzalez, Mexico City, DF, Mexico

[10] San Antonio Hlth Syst, San Antonio, TX USA

[11] Camp Lejeune, Jacksonville, NC USA

[12] Naval Med Ctr Portsmouth, Portsmouth, VA USA

[13] Walter Reed Natl Mil Med Ctr, Bethesda, MD USA

[14] Naval Hlth Res Ctr, San Diego, CA USA

[15] Naval Med Ctr San Diego, San Diego, CA USA

来源：

BMC INFECTIOUS DISEASES | 2016年 / 16卷

基金：

美国国家卫生研究院;

关键词：

Influenza; Symptoms; Patient-reported outcomes; Endpoints; Outcome assessments; Content validity; TASK-FORCE REPORT; CONTENT VALIDITY;

D O I：

10.1186/s12879-015-1330-0

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

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.

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