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BMC Infect Dis. 2016 Jan 5;16:1. doi: 10.1186/s12879-015-1330-0.

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

Author information

1
Clinical Monitoring and Research Program, Clinical Research Directorate, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD, 21702 in support of the Collaborative Clinical Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA. john.powers@nih.gov.
2
, 5601 Fishers Lane, Room 4D50, Rockville, MD, 20852, USA. john.powers@nih.gov.
3
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. mlga08@gmail.com.
4
Evidera, Bethesda, MD, USA. nancy.leidy@evidera.com.
5
Infectious Disease Clinical Research Program, Uniformed Services University, Bethesda, MD, USA. mary.p.fairchok.ctr@mail.mil.
6
Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. mary.p.fairchok.ctr@mail.mil.
7
Madigan Army Medical Center, Tacoma, WA, USA. mary.p.fairchok.ctr@mail.mil.
8
Clinical Monitoring and Research Program, Clinical Research Directorate, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD, 21702 in support of the Collaborative Clinical Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA. arosenberg@mail.nih.gov.
9
Instituto Nacional de Enfermedades Infecciosas, Mexico City, Mexico. andreshernandez57@gmail.com.
10
Evidera, Bethesda, MD, USA. sonja.stringer@evidera.com.
11
Madigan Army Medical Center, Tacoma, WA, USA. christina.m.schofield2.civ@mail.mil.
12
Hospital General Dr. Manuel Gea González, Mexico City, Mexico. rozu76@hotmail.com.
13
Evidera, Bethesda, MD, USA. katherine.kim@evidera.com.
14
San Antonio Health System, San Antonio, TX, USA. patrick.j.danaher6.mil@mail.mil.
15
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. hilda.ortega.innsz@gmail.com.
16
Evidera, Bethesda, MD, USA. elizabeth.bacci@evidera.com.
17
Camp Lejeune, Jacksonville, NC, USA. nathaniel.stepp@med.navy.mil.
18
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. galindofraga@yahoo.com.
19
Naval Medical Center Portsmouth, Portsmouth, VA, USA. Kristina.j.stclair.mil@mail.mil.
20
Walter Reed National Military Medical Center, Bethesda, MD, USA. michael.rajnik@usuhs.edu.
21
Naval Health Research Center, San Diego, CA, USA. erin.mcdonough@med.navy.mil.
22
Infectious Disease Clinical Research Program, Uniformed Services University, Bethesda, MD, USA. michelande.ridore@gmail.com.
23
Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. michelande.ridore@gmail.com.
24
Naval Medical Center San Diego, San Diego, CA, USA. john.arnold@med.navy.mil.
25
Infectious Disease Clinical Research Program, Uniformed Services University, Bethesda, MD, USA. emillar@idcrp.org.
26
Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. emillar@idcrp.org.
27
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. gmrps@servidor.unam.mx.

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.

PMID:
26729246
PMCID:
PMC4700740
DOI:
10.1186/s12879-015-1330-0
[Indexed for MEDLINE]
Free PMC Article

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