Assessments in depth¶
Questionnaires in Tinnitus Ripple are not built per trial. They live in a shared assessments library, and one generic system handles all of them, from definition through to scoring. This chapter explains that system and then lists the questionnaires the ART trial uses (see About the trial). To choose questionnaires for a trial, see Step 2 · Assessments.
How a questionnaire is put together¶
- Definition
An assessment is a set of questions of a few kinds: sliders, choices, free text, and numbers. This definition lives in the library and can be reused across trials.
- Binding to a trial
When you tick a questionnaire in Step 2, it is bound to the trial with a timing (when it is asked), whether it is required, and where it appears.
- Availability
The portal works out when each questionnaire is due for a given participant, from its timing and where the participant is in the trial.
- Delivery and rendering
The app fetches whatever is due and draws it with a single generic renderer, so any questionnaire in the library can be shown without app changes (except a few kinds not yet supported, which are flagged in Step 2).
- Submission and scoring
When a participant submits, their answers are stored and any scores are computed automatically. Free-text and number answers are stored as given.
The ART trial’s questionnaires¶
Screening (at enrolment)¶
Confirms eligibility before anyone can take part. It covers age (must be 18 or over), whether the person has tinnitus, red-flag symptoms that should prompt medical attention, how long the tinnitus has been present (with a warning under seven days), hearing-aid or cochlear-implant use, a self-report of hearing ability (insufficient hearing stops the person proceeding), how noisy environments affect the tinnitus, which ear or ears are affected, and relevant health conditions and medications. Some answers block enrolment; others show a warning but allow the person to continue.
Baseline and washout measures¶
Three standard instruments are asked at the start and at the end of each washout period:
Tinnitus Handicap Inventory (THI), 25 questions.
Tinnitus Functional Index (TFI).
Inventory of Hyperacusis Symptoms (IHS).
Daily ratings¶
Immediately before and after each daily listening session, participants answer three 0 to 10 slider questions:
How loud is your tinnitus right now? (0 = no sound, 10 = loudest possible)
How much is your tinnitus bothering you right now? (0 = not at all, 10 = extremely)
How relaxed or stressed do you feel right now? (0 = very relaxed, 10 = very stressed)
On washout days, when there is no listening, the same questions are asked once per day.
Blinding guess¶
After the first day of each treatment block, participants are asked whether they think they received the active or the placebo therapy (a five-point confidence scale). This is the blinding check you toggle in Step 2 · Assessments.
End of study¶
At the end, participants answer how the trial affected their tinnitus loudness, bother/distress, awareness, and sense of control; whether they intend to keep using the active therapy; a free-text fair monthly subscription fee; whether they would recommend the therapy; and any other comments. They then receive a debrief revealing which condition they had at which time.
Timings summary¶
Questionnaire |
When |
|---|---|
Screening |
At enrolment |
THI / TFI / IHS |
Baseline, and end of each washout |
Three daily sliders |
Before and after each session; once daily in washout |
Blinding guess |
After the first day of each block |
End-of-study questions and debrief |
End of trial |
The point is that adding or changing a questionnaire is a library-and-configuration task, not a development task: define it once, bind it to the trials that need it, and choose when it is asked.