The RiiQ™ and flu-iiQ™ are sensitive, multi-dimensional Patient Reported Outcome Measures (PROMs) used to evaluate the potential patient-centred benefits of new respiratory infection treatments, including vaccines and anti-viral drugs.
Our questionnaires
The RiiQ™, the Respiratory Infection Intensity and Impact Questionnaire, is a sensitive, multi-dimensional Patient Reported Outcomes Measure (PROM) used to evaluate the effectiveness of new respiratory infection treatments, including vaccines and anti-viral drugs, and applied in epidemiological research.
The RiiQ™ is an extension of the flu-iiQ™ (Influenza Intensity and Impact Questionnaire) which is the most widely used and trusted influenza and influenza-like illness PROM worldwide. The RiiQ™ was developed to provide more precision and breadth for assessment in clinical trials and includes all the items from the flu-iiQ™ plus an additional three respiratory items.
The RiiQ™ was developed in collaboration with Janssen Pharmaceuticals. It has been applied in a range of local and global epidemiological and clinical trials. Its psychometric properties were published in 2023 in the Journal of Patient Reported Outcomes.
Some of the reasons why many leading pharmaceutical companies and research teams choose to use the RiiQTM and flu-iiQTM PROMs:
Meeting the needs of industry and regulatory bodies
Developed to serve the needs of the pharmaceutical industry and to meet and exceed the requirements of regulatory bodies such as the FDA. The RiiQ™ and flu-iiQ™ have been used for:
Vaccine development and testing
Investigational drug development and testing
Generation of efficacy data and to support marketing claims
Epidemiological surveys and monitoring
Proven and trusted
The flu-iiQ™ has been serving the pharmaceutical industry since 2008 and has been administered over 700,000 times, in over 40 countries, across all continents in Phase 1, Phase 2 and Phase 3 clinical trials, as well as in epidemiological surveys and prevention trials.
The RiiQ™ was first developed in 2016 and implemented in a number of trials. Based on the flu-iiQ™, the RiiQ™ is now widely used in RSV, Influenza and other respiratory infection clinical trials and epidemiological studies.
Available in over 50 languages
Both the RiiQ™ and flu-iiQ™ have been translated, culturally adapted and measurement adapted to over 50 languages, for multinational influenza treatment and prevention trials.
A single licence fee covers use of any of the 50+ existing translations for your study
Measures the multi-dimensional impact of infectious diseases
Extensive and systematic consultation with patients and physicians using concept mapping1 plus an extensive literature review were used to derive the following dimensions of influenza intensity (only 10 items in total) and the additional impact scales (3 scales each with 4 to 6 items):
Symptom intensity
respiratory symptoms (3 items)
systemic symptoms (7 items)
Impact
daily activities (6 items)
other people (4 items)
emotions (5 items)
1 Rosas SR, Ridings JW. The use of concept mapping in measurement development and evaluation: Application and future directions. Evaluation and Program Planning. 60:1, 2017, p265-276
Globally recognised
The flu-iiQ™ is the only influenza tool to be included in the Clinical Data Interchange Standards Consortium (CDISC) Standards initiative. 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.
Developed by experts
The development of the RiiQ™ and flu-iiQ™ was led by Dr Richard Osborne, who has more than 20 years’ experience in the development and application of PROMs and has produced over 10 PROMs, several of which are used globally.
Using a validity driven approach, the development of the RiiQ™ and flu-iiQ™ involved specialist psychometricians, expert clinicians, clinical trialists and in-depth consultations with patients with confirmed infections. The flu-iiQ™ was initially validated across 25 sites in the US.
Easily adapted to a range of delivery formats
The RiiQ™ and flu-iiQ™ are suitable for use in a range of formats including paper, telephone, hand-held device and internet.
The RiiQTM and flu-iiQTM in figures
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Comprehensive evaluation of the potential range of benefits of new agents requires a valid, sensitive and comprehensive multi-dimensional PROM. The RiiQTM and flu-iiQTM meet these requirements.
