Flu iiq

The flu-iiQTM: Influenza intensity and impact Questionnaire

The flu-iiQTM (pronounced flu-eye-q) was developed using a validity-driven approach to serve the pharmaceutical and research communities. It is a multi-dimensional questionnaire being used in many settings and all continents.

Flu-iiQTM applications include:

  • Vaccine development and testing
  • Investigational drug development and testing
  • Generation of efficacy data and to support marketing claims
  • Epidemiological surveys and monitoring

The flu-iiQTM is the most trusted and frequently used Patient Report Outcomes Measure (PROM) in this setting that meets and exceeds modern psychometric standards. Its development involved specialist psychometricians, expert clinicians, clinical trialists, in-depth consultations with patients with confirmed flu, and was initially validated across 25 sites in the US.

The flu-iiQTM has been translated, culturally adapted and measurement adapted to 39 languages for multinational influenza treatment and prevention trials. It has been used in over 40 countries in Phase 1, Phase 2 and Phase 3, epidemiological surveys and prevention trials.

The developer
The flu-iiQTM was developed by Dr RH Osborne, who has produced over 10 PROMs, several of which are used globally. He has published over 70 peer reviewed scientific manuscripts specifically on PROM development and validation, and over 100 manuscripts on the application of PROMs including in respected journals such as the NEJM, The Lancet, British Medical Journal, Value in Health and Quality of Life Research, and others.

Development of the flu-iiQTM
Motivation to develop the flu-iiQTM arose from a clear need in the industry and from the limitations of an earlier questionnaire, the influenza symptom scale (ISS) and the accompanying influenza wellbeing scale (IIWS) 1. Although this questionnaire contributed to the understanding of the effectiveness of oseltamivir (Tamiflu) and its subsequent widespread approval, as well as other antiviral drugs and vaccines, the questionnaires assessed a limited range of outcomes and needed redevelopment for the modern vaccine and pharmaceutical agents.

The rigorous procedure to develop and validate the flu-iiQTM was published in the prestigious international scientific journal Value in Health in 2011. See link to the citation: Osborne RH, Norquist JM, Mehta V, Elsworth GE, Busija L, V Mehta, T Herring, Gupta S. Development and validation of the intensity and impact of influenza questionnaire (Flu-iiQ). Value in Health. 2011, 14: 687-699

Global recognition of theĀ flu-iiQTM
The flu-iiQTM has been included in the Clinical Data Interchange Standards Consortium (CDISC) Standards. CDISC Therapeutic Area Standards are developed under the Coalition for Accelerating Standards and Therapies (CFAST program), a joint initiative of CDISC and the Critical Path Institute (C-Path) with partners including TransCelerate BioPharma Inc, the U.S. Food and Drug Administration (FDA) and the National Institute of Health (NIH). These standards provide guidelines on the implementation of the Study Data Tabulation Model (SDTM) to represent disease-specific data in regulatory submissions.

The flu-iiQTM questionnaire is copyright and may only be used with permission from MESH.
A database of registered users is maintained to monitor usage and protect copyright.

 

1 Osborne R et al. Measurement of rapid changes in health-related quality of life (HQoL) in people with influenza. Journal of Outcomes Research. 2000; 4:15-30.