| Primary outcome instruments | Secondary outcome instruments | ||
---|---|---|---|---|
 | Number | Percentage (%) | Number | Percentage (%) |
(1a) Investigator-administered tests relating to the tinnitus percept: | ||||
 Tinnitus loudness matching | 20 | 4 % | 16 | 3 % |
 Tinnitus pitch matching | 9 | 2 % | 22 | 4 % |
 Minimum masking level | 5 | 1 % | 12 | 2 % |
 Loudness discomfort level | 3 | 1 % | 2 | 0 % |
 Tinnitus bandwidth matching | 0 | - | 2 | 0 % |
(1b) Patient-reported numerical rating scales relating to the tinnitus percept: | ||||
 Tinnitus loudness | 37 | 8 % | 24 | 4 % |
 Tinnitus pitch | 0 | - | 2 | 0 % |
(2a) Patient-reported questionnaire instruments relating to the impact of tinnitus: | ||||
 Tinnitus Handicap Inventory | 77 | 15 % | 31 | 5 % |
 Tinnitus Questionnaire (German version) | 29 | 6 % | 11 | 2 % |
 Tinnitus Questionnaire (English version) | 5 | 1 % | 0 | - |
 Tinnitus Functional Index | 18 | 4 % | 3 | 1 % |
 Tinnitus Beeinträchtigungs Fragebogen | 13 | 3 % | 8 | 1 % |
 Tinnitus Severity Index | 12 | 2 % | 1 | 0 % |
 Tinnitus Reaction Questionnaire | 11 | 2 % | 2 | 0 % |
 Tinnitus Handicap Questionnaire | 8 | 2 % | 5 | 1 % |
 Mini-Tinnitus Questionnaire | 6 | 1 % | 0 | - |
 Tinnitus Effects Questionnaire | 2 | 0 % | 0 | - |
 Tinnitus diary | 2 | 0 % | 0 | - |
 Tinnitus Psychological Impact Questionnaire | 2 | 0 % | 0 | - |
 Tinnitus Severity Scale | 0 | - | 6 | 1 % |
 Tinnitus Acceptance Questionnaire | 0 | - | 6 | 1 % |
(2b) Patient-reported numerical rating scales relating to the impact of tinnitus: | ||||
 Tinnitus distress | 7 | 2 % | 8 | 1 % |
 Tinnitus annoyance | 21 | 4 % | 14 | 2 % |
 Tinnitus awareness | 10 | 2 % | 2 | 0 % |
(3) Patient-reported questionnaire instruments relating to other co-occurring complaints: | ||||
 Beck Depression Inventory | 7 | 1 % | 13 | 2 % |
 Hospital Anxiety and Depression Scale | 7 | 1 % | 27 | 5 % |
 Perceived Stress Questionnaire | 3 | 1 % | 0 | - |
 Spielberger State and Trait Anxiety Inventory | 3 | 1 % | 3 | 1 % |
 Brief-Coping with Problems Experienced | 2 | 0 % | 0 | - |
 Pittsburgh Sleep Quality Index | 2 | 0 % | 2 | 0 % |
 Hearing Handicap Inventory | 1 | 0 % | 4 | 1 % |
 Hyperacusis questionnaire (undefined) | 1 | 0 % | 2 | 0 % |
 Attention and Performance Self-assessment Scale | 0 | - | 2 | 0 % |
 Befindlichkeitsskala | 0 | - | 2 | 0 % |
 Cognitive Failures Questionnaire | 0 | - | 2 | 0 % |
 Depression Anxiety and Stress Scale | 0 | - | 3 | 1 % |
 Insomnia Severity Index | 0 | - | 7 | 1 % |
 Major Depression Inventory | 0 | - | 5 | 1 % |
 Sleep Questionnaire (undefined) | 0 | - | 3 | 1 % |
(4a) Patient-reported questionnaire instruments relating to health-related quality of life: | ||||
 Clinical Global Impression Scale | 4 | 1 % | 14 | 2 % |
 36-item short form Health Survey | 2 | 0 % | 6 | 1 % |
 WHOQOL-BREF | 0 | - | 10 | 2 % |
 EuroQoL | 0 | - | 2 | 0 % |
 Quality of Life Inventory | 0 | - | 2 | 0 % |
(4b) Patient-reported numerical rating scales relating to health-related quality of life: | ||||
 Quality of Life (tinnitus) | 5 | 1 % | 6 | 1 % |
 Quality of Life | 4 | 1 % | 1 | 0 % |
(5) Technical and laboratory measurements relating to body structures and functions: | ||||
 Pure tone audiometry | 15 | 3 % | 23 | 4 % |
 Speech audiometry (various types) | 6 | 1 % | 11 | 2 % |
 Electroencephalography | 4 | 1 % | 5 | 1 % |
 Blood chemistry | 2 | 0 % | 10 | 2 % |
 Positron Emission Tomography | 2 | 0 % | 0 | - |
 Electrocardiogram | 1 | 0 % | 4 | 1 % |
 Digit symbol test | 1 | 0 % | 2 | 0 % |
 Blood drug levels | 0 | - | 4 | 1 % |
 Magnetic Resonance Imaging | 0 | - | 3 | 1 % |
 Otological examination | 0 | - | 4 | 1 % |
 Otoscopy | 0 | - | 2 | 0 % |
 Psychoacoustic assessment (undefined) | 0 | - | 3 | 1 % |
 Tympanometry | 0 | - | 2 | 0 % |
 Urine analysis | 0 | - | 2 | 0 % |
(6) Measures of adverse events or harms: | ||||
 Adverse events/Side effects | 4 | 1 % | 30 | 5 % |
(7) Measures of satisfaction: | No instruments reported | |||
(8) Measurement instruments of treatment-related outcomes: | ||||
 Withdrawal rate | 2 | 0 % | 2 | 0 % |
(9) Measurement of interest unclear or not specified by the authors: | ||||
 Cannot code | 20 | 4 % | 52 | 9 % |
 Other numerical rating scale (undefined) | 18 | 4 % | 29 | 5 % |
 Questionnaire (authors’ own) | 15 | 3 % | 13 | 2 % |
 Numerical rating scale of tinnitus severity | 12 | 2 % | 1 | 0 % |
 Not specified | 8 | 2 % | 18 | 3 % |
Total | 505 | 87Â % | 579 | 85Â % |