The RiiQ™ and flu-iiQ™ have 5 scales - can we use just one of the scales?
Yes: Many clinical trialists have a specific research question that focuses on symptoms, hence they only use the Symptom scales, i.e., 2 scales total of 13 items, across Respiratory symptoms and Systemic symptoms.
Whether or not you use all 5 scales depends on the known or hypothesized action of the drug/vaccine you are testing. The two ‘Symptom Intensity’ scales and ‘Impact on Daily Activities’ scale are likely to be the most sensitive to change and therefore more likely to reveal superiority. If you are only interested in ‘Symptom Intensity’ then you can just use the 13 symptom questions.
There are 5 sets of scales because people with respiratory infection told us during the comprehensive PROM development phases that this was the full range of impacts on their lives related to infection.
How is it scored?
Each scale is scored by adding the score for each item (0 to 3) and dividing by the number of items in the scale. CDISC templates also provide standard values for scoring so this it is globally consistent (e.g., none = 0, severe = 3).
How are they used to estimate efficacy?
The RiiQ™ and flu-iiQ™ are typically administered for between 7 and 20 days following onset of symptoms. The scales are used to compare intervention and control groups using average maximum symptoms, symptom duration, or a combination of these two (Area Under the Curve analysis). Other comparisons include ‘time to baseline symptoms’ or ‘time to return to usual activities’.
How do I obtain a licence to use the RiiQ™ or flu-iiQ™ for my study?
Please complete the licence registration form and we will provide a licence fee quotation and a copy of our standard licence agreement for your review.
What is the difference between the flu-iiQ™ and the RiiQ™.
The RiiQ™ includes the 10 items from the flu-iiQ™ and 3 new symptoms that improve its comprehensiveness for respiratory symptoms. The new symptoms were derived from in-depth interviews with patients and clinicians.
Can the RiiQ™ or flu-iiQ™ be administered as an ePRO?
Yes. The questionnaires have simple text and can be included in your study protocols using your preferred formats - ePRO, paper, interviewer administered, telephone etc.
Are the RiiQ™ or flu-iiQ™ a burden on patients, leading to dropouts?
No. Years of trial experience and anecdotes from trialists have found that when the symptoms on a questionnaire are clear, relevant, and truly resonate with what they are experiencing, they are not a burden. In fact, the short questionnaire can help keep patients engaged in the trial and prevent dropouts.
How long does it take to complete?
The 13 Symptoms take about two to three minutes. The Impact scales take a further two to five minutes.
Can someone else, other than the patient, fill in the questionnaire?
These PROMs can be administered as an interview by a trained interviewer, however they are primarily intended to be self-completed by the patient.
The flu-iiQ™ and RiiQ™ are trusted PROMs measuring the multi-dimensional impact of influenza, RSV and other respiratory illnesses.
