Table 4.
Overview of assessments for the UNITI-RCT
| Pre-screening | Screening | Baseline | Treatment start | Interim visit | Final visit = end of treatment | Follow-up | Additional follow-up | |
|---|---|---|---|---|---|---|---|---|
| ICF | Aa | A | ||||||
| Eligibility criteria | A | A | A | |||||
| ESIT-SQ | A | |||||||
| TSCHQ | B | |||||||
| Mini TQ | A | A | A | A | A | A | B | |
| Tinnitus numeric rating scales | A | A | A | A | A | B | ||
| TFI | A | A | A | A | A | B | ||
| THI | A | A | A | A | A | A | B | |
| WhoQol-BREF | A | A | A | A | A | B | ||
| BFI-2 | A | |||||||
| CGI-I | A | A | A | B | ||||
| GUF | B | B | B | B | B | B | ||
| PHQ-D | A | A | A | A | A | A | B | |
| Mini-SOISES | A | A | A | A | B | |||
| ATAQ | Bb | Bb | ||||||
| FTQ | B | B | B | B | B | |||
| MoCA | A | |||||||
| Randomization | A | |||||||
| Blood sampling | Bc | |||||||
| Otological examination | A | A | B | B | ||||
| Audiometry | A | A | B | B | ||||
| Loudness match | A | A | B | B | ||||
| Pitch match | A | A | B | B | ||||
| Maskability | A | A | B | B | ||||
| Residual inhibition | A | B | B | B | ||||
| ABR | A | B | B | |||||
| AMLR | A | B | B | |||||
| Treatment | A | A | A | |||||
| Comorbidities | A | A | A | A | A | A | B | |
| Concomitant medication/ treatment | A | A | A | A | A | A | B | |
| Adverse events | A | A | A | B |
Table reproduced from [1] (CC BY 4.0). Interim visit: week 6; final visit: week 12; follow-up: week 36; additional follow-up: week 48. A mandatory, B voluntary, ICF Informed Consent Form, ESIT-SQ European School of Interdisciplinary Tinnitus Research Screening Questionnaire, TSCHQ Tinnitus Sample Case History, Mini-TQ Mini Tinnitus Questionnaire, TFI Tinnitus Functional Index, THI Tinnitus Handicap Inventory, WhoQol-BREF World Health Organization Quality of Life – abbreviated, BFI-2 Big Five Inventory-2, CGI-I Clinical Global Impression Scale – Improvement, GUF Questionnaire on Hypersensitivity to Sound, PHQ-D Patient Health Questionnaire for Depression, SOISES Social Isolation Electronic Survey, ATAQ Attitudes Towards Amplification Questionnaire, FTQ Fear of Tinnitus Questionnaire, MoCA Montreal Cognitive Assessment, ABR auditory brainstem response, AMLR auditory middle latency response
Screening and Baseline measurements as well as treatment start can be performed on the same day. In this case, all measurements are only performed once. The baseline should be maximum 4 weeks before the treatment start; otherwise, baseline measures should be repeated (without ESIT-SQ, TSCHQ, BFI-2, ATAQ, electrophysiological measurements)
aDeclaration of consent (ICF) can be digital for the pre-screening
bOnly for participants who were allocated to a single or combinational treatment with HA
cBlood samples can be taken at any time point before treatment start