Development and validation of the influenza intensity and impact questionnaire (FluiiQ™)

Osborne, Richard H., Norquist, Josephine M., Elsworth, Gerald R., Busija, Lucy, Mehta, Vinay, Herring, Tim and Gupta, Swati W. 2011, Development and validation of the influenza intensity and impact questionnaire (FluiiQ™), Value in health, vol. 14, no. 5, July-August, pp. 687-699.

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Title Development and validation of the influenza intensity and impact questionnaire (FluiiQ™)
Author(s) Osborne, Richard H.
Norquist, Josephine M.
Elsworth, Gerald R.
Busija, Lucy
Mehta, Vinay
Herring, Tim
Gupta, Swati W.
Journal name Value in health
Volume number 14
Issue number 5
Season July-August
Start page 687
End page 699
Total pages 13
Publisher Elsevier
Place of publication Amsterdam, The Netherlands
Publication date 2011-07
ISSN 1098-3015
1524-4733
Keyword(s) clinical trial
influenza
patient-reported outcomes
psychometrics
surveillance
questionnaire validation
Summary Objective
Clinical trials of new agents to reduce the severity and impact of influenza require accurate assessment of the effect of influenza infection. Because there are limited high-quality adult influenza Patient Reported Outcomes (PRO) measures, the aim was to develop and validate a simple but comprehensive questionnaire for epidemiological research and clinical trials.

Methods
Construct and item generation was guided by the literature, concept mapping, focus groups, and interviews with individuals with laboratory-confirmed influenza and expert physicians. Items were administered to 311 people with influenza-like illness (ILI) across 25 US sites. Analyses included classic psychometrics, structural equation modeling (SEM), and Rasch analyses.

Results
Concept mapping generated 149 concepts covering the influenza experience and clustered into symptoms and impact on daily activities, emotions, and others. Items were drafted using simplicity and brevity criteria. Eleven symptoms from the literature underwent review by physicians and patients, and two were removed and one added. The symptoms domain factored into systemic and respiratory symptoms, whereas the impact domains were unidimensional. All domains displayed good internal consistency (Cronbach α ≥ 0.8) except the three-item respiratory domain (α = 0.48). A five-factor SEM indicated excellent fit where systemic, respiratory, and daily activities domains differentiated patients with ILI or confirmed influenza. All scales were responsive over time.

Conclusions
Patient and clinician consultations resulted in an influenza PRO measure with high validity and good overall evidence of reliability and responsiveness. The Influenza Intensity and Impact Questionnaire (FluiiQ™) will improve the evaluation of existing and future agents designed to prevent or control influenza infection by increasing the breadth and depth of measurement in this field.
Language eng
Field of Research 110309 - Infectious Diseases
Socio Economic Objective 920408 - Health Status (e.g. Indicators of Well-Being)
HERDC Research category C1.1 Refereed article in a scholarly journal
Copyright notice ©2011, Elsevier
Persistent URL http://hdl.handle.net/10536/DRO/DU:30061502

Document type: Journal Article
Collections: School of Health and Social Development
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Created: Mon, 10 Mar 2014, 15:10:01 EST by Lucy Busija

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