Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | September 2014 |
| End Date: | January 2016 |
| Contact: | Michelande Ridore |
| Email: | mridore@idcrp.org |
| Phone: | 301-816-8452 |
There is no standardized method for evaluating the symptoms of influenza. A standardized
instrument for measuring influenza symptoms, with appropriate scientifically derived content
and construct validity would have value for public health in terms of use as a validated
outcome measure in interventions to treat or prevent influenza. The instrument also could
serve as part of an overall measure of severity of illness in influenza. Previous efforts in
participant reported outcomes (PRO) for influenza (i.e. Flu-PRO Stage I and Stage II)
focused on the elicitation and evaluation of items for inclusion in the instrument. The
overarching objective of this protocol - Flu-PRO Stage III - is to conduct instrument
validation to evaluate item properties and, if need be, reduce the number of items, and
quantitatively validate the performance of the final measure.
instrument for measuring influenza symptoms, with appropriate scientifically derived content
and construct validity would have value for public health in terms of use as a validated
outcome measure in interventions to treat or prevent influenza. The instrument also could
serve as part of an overall measure of severity of illness in influenza. Previous efforts in
participant reported outcomes (PRO) for influenza (i.e. Flu-PRO Stage I and Stage II)
focused on the elicitation and evaluation of items for inclusion in the instrument. The
overarching objective of this protocol - Flu-PRO Stage III - is to conduct instrument
validation to evaluate item properties and, if need be, reduce the number of items, and
quantitatively validate the performance of the final measure.
The overarching purpose of this study is to develop a single, standardized measurement scale
of participant influenza symptoms for use in clinical studies involving adult and pediatric
participants. The development of an instrument for participant reported outcomes of
influenza was composed of three stages, as described below:
Stage I. Elicitation interviews in a group of volunteers with laboratory-confirmed influenza
to inform the development of the instrument, including its content and structure (item
phrasing, length, response options, recall).
Stage II. Evaluative interviews with a second set of volunteers with laboratory-confirmed
influenza to assess comprehension and interpretability of the instrument and draft item pool
from the respondent's perspective.
Stage III. Item reduction and instrument validation in a third set of volunteers to evaluate
item properties and quantitatively validate the performance of the final measure.
This protocol will describe the rationale, design, data collection procedures, and analysis
methods for Stage III - Item Reduction and Instrument Validation.
of participant influenza symptoms for use in clinical studies involving adult and pediatric
participants. The development of an instrument for participant reported outcomes of
influenza was composed of three stages, as described below:
Stage I. Elicitation interviews in a group of volunteers with laboratory-confirmed influenza
to inform the development of the instrument, including its content and structure (item
phrasing, length, response options, recall).
Stage II. Evaluative interviews with a second set of volunteers with laboratory-confirmed
influenza to assess comprehension and interpretability of the instrument and draft item pool
from the respondent's perspective.
Stage III. Item reduction and instrument validation in a third set of volunteers to evaluate
item properties and quantitatively validate the performance of the final measure.
This protocol will describe the rationale, design, data collection procedures, and analysis
methods for Stage III - Item Reduction and Instrument Validation.
Inclusion Criteria:
- DEERS eligible
- Adults ≥18 years
- Influenza or influenza-like symptoms as defined by one or more of the following:
- Positive influenza test by PCR, culture, and/or rapid antigen testing
- Fever with temperature ≥100.4° F [38° C] AND Respiratory Symptoms* OR
- Subjective fever AND Respiratory Symptoms* [*Respiratory Symptoms: cough, or
sputum production, or shortness of breath, or chest pain, and/or sore throat]
- Speak and read English
- Access to the internet through computer, laptop, tablet, or smartphone
Exclusion Criteria:
- Individuals who do not have access to the internet by computer, laptop, tablet, or
smartphone
- Individuals with cognitive and/or physical disabilities who are unable to use a touch
screen or computer mouse to enter information into an internet-based survey
We found this trial at
5
sites
8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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