Background
Material and methods
Database
Assessments
Questionnaire | (sub)scales | No of items | Response scale | Range of score |
---|---|---|---|---|
THI
| Total | 25 | 0/2/4 (yes/sometimes/no) | 0-100 |
TBF12*
| Total | 12 | 0/1/2 (never/sometimes/often) | 0-24 |
TQ
| Total | 52 (40**) | 0/1/2 (true/partly true/not true) | 0-84 |
Emotional distress | 12 | 0/1/2 (true/partly true/not true) | 0-24 | |
Cognitive distress | 8 | 0/1/2 (true/partly true/not true) | 0-16 | |
Intrusiveness | 8 | 0/1/2 (true/partly true/not true) | 0-16 | |
Auditory perceptual difficulties | 7 | 0/1/2 (true/partly true/not true) | 0-14 | |
Sleep disturbances | 4 | 0/1/2 (true/partly true/not true) | 0-8 | |
Somatic complaints | 3 | 0/1/2 (true/partly true/not true) | 0-6 | |
Mini-TQ***
| Total | 10 | 0/1/2 (true/partly true/not true) | 0-20 |
TQ 12***
| Total | 12 | 0/1/2 (true/partly true/not true) | 0-24 |
Questionnaire | Total | Germany (German) | Belgium (Dutch) | Brazil (Portuguese) | Argentina (Spanish) |
---|---|---|---|---|---|
THI totalscore
| |||||
- Baseline | 1292 | 1127 | 34 | 98 | 33 |
- Final Visit | 350 | 237 | 19 | 78 | 16 |
TBF12 totalscore
| |||||
- Baseline | 685 | 534 | 35 | 83 | 33 |
- Final Visit | 341 | 238 | 19 | 71 | 13 |
TQ* totalscore
| |||||
- Baseline | 1108 | 1108 | 0 | 0 | 0 |
- Final Visit | 309 | 309 | 0 | 0 | 0 |
Tinnitus severity
| |||||
- Baseline | 1139 | 995 | 29 | 82 | 33 |
- Final Visit | 364 | 263 | 14 | 71 | 16 |
PGI-C
| |||||
- Final Visit | 429 | 328 | 18 | 79 | 4 |
Statistical analysis
Reliability
Validity
Sensitivity
Results
Patient characteristics
Age (years), median (IQR) | 53.2 (44.7; 62.3) | |
---|---|---|
Tinnitus duration (years), median (IQR) | 5.2 (1.6; 12.2) | |
Sex (N, %) | ||
Male | 844 | (64.0%) |
Female | 474 | (36.0%) |
Country (language) (N,%) | ||
Germany (German) | 1149 | (87.2%) |
Belgium (Dutch) | 38 | (2.9%) |
Brazil (Portuguese) | 98 | (7.4%) |
Argentina (Spanish) | 33 | (2.5%) |
Laterality (N, %*) | ||
Right | 391 | (29.7%) |
Left | 504 | (38.2%) |
Both sides/inner head | 401 | (30.4%) |
Tinnitus severity at baseline on the basis of the THI (N, %*) | ||
Slight | 129 | (9.8%) |
Mild | 344 | (26.1%) |
Moderate | 361 | (27.4%) |
Severe | 307 | (23.3%) |
Catastrophic | 151 | (11.5%) |
Etiology (N, %**) | ||
Noise trauma | 238 | (18.1%) |
Injury of cervical spine | 174 | (13.2%) |
Change of hearing | 327 | (24.8%) |
Stress | 565 | (42.9%) |
Head injury | 155 | (11.8%) |
Other | 573 | (43.4%) |
Type of treatment (N, %) | ||
Pharmacological treatment | 237 | (18.0%) |
Transcranial direct current stimulation | 33 | (2.5%) |
Transcutaneous vagus nerve stimulation | 24 | (1.8%) |
Repetitive transcranial magnetic stimulation | 260 | (19.7%) |
Other | 37 | (2.8%) |
None (only baseline) | 727 | (55.2%) |
Reliability
Questionnaire | Total | Germany (German) | Belgium (Dutch) | Brazil (Portuguese) | Argentina (Spanish) |
---|---|---|---|---|---|
THI
| |||||
- Baseline | 0.92 | 0.93 | 0.93 | 0.92 | 0.95 |
- Final Visit | 0.94 | 0.94 | 0.93 | 0.95 | 0.93 |
TBF12
| |||||
- Baseline | 0.88 | 0.88 | 0.89 | 0.84 | 0.92 |
- Final Visit | 0.90 | 0.89 | 0.90 | 0.92 | 0.79 |
TQ
| |||||
- Baseline | 0.95 | 0.95 | - | - | - |
- Final Visit | 0.95 | 0.95 | - | - | - |
Mini-TQ
| |||||
- Baseline | 0.87 | 0.87 | - | - | - |
- Final Visit | 0.88 | 0.88 | - | - | - |
TQ 12
| |||||
- Baseline | 0.87 | 0.87 | - | - | - |
- Final Visit | 0.87 | 0.87 | - | - | - |
Validity
Questionnaire | THI | TBF12 | TQ | TQ Mini | |||||
---|---|---|---|---|---|---|---|---|---|
Baseline | Final | Baseline | Final | Baseline | Final | Baseline | Final | ||
TBF12
| Total | 0.84 (n=678) | 0.86 (n=339) | 1 | |||||
German | 0.87 (n=528) | 0.89 (n=236) | |||||||
Dutch | 0.64 (n=34) | 0.90 (n=19) | |||||||
Portuguese | 0.79 (n=83) | 0.78 (n=71) | |||||||
Spanish | 0.79 (n=33) | 0.43* (n=13) | |||||||
TQ
| Total/ German | 0.87 (n=1089) | 0.90 (n=217) | 0.83 (n=503) | 0.85 (n=218) | 1 | |||
Mini-TQ
| Total/ German | 0.87 (n=1052) | 0.90 (n=216) | 0.82 (n=490) | 0.87 (n=217) | 0.93 (n=1071) | 0.94 (n=307) | 1 | |
TQ 12
| Total/ German | 0.87 (n=1056) | 0.89 (n=214) | 0.81 (n=490) | 0.85 (n=215) | 0.94 (n=1074) | 0.95 (n=305) | 0.96 (n=1063) | 0.96 (n=305) |
Tinnitus severity at baseline | Not a problem | A small problem | A moderate problem | A big problem | A very big problem | Correlation (Spearman) | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
Questionnaire | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | r |
THI
| |||||||||||
- total | 17 | 20.0 (11.5) | 149 | 26.5 (16.5) | 425 | 37.8 (17.6) | 419 | 58.0 (18.6) | 113 | 74.1 (15.8) | 0.64** |
- German | 16 | 20.8 (11.5) | 136 | 26.4 (16.9) | 366 | 37.9 (17.7) | 378 | 58.1 (18.4) | 87 | 73.4 (15.8) | 0.63** |
- Dutch | 0 | - | 0 | - | 9 | 37.3 (14.5) | 6 | 64.7 (19.2) | 10 | 75.0 (15.3) | 0.70** |
- Portuguese | 1 | 8.0 (−) | 12 | 28.0 (12.6) | 36 | 39.3 (16.6) | 21 | 55.6 (17.8) | 12 | 76.5 (16.9) | 0.67** |
- Spanish | 0 | - | 1 | 14.0 (−) | 14 | 32.1 (19.9) | 14 | 54.6 (14.9) | 4 | 80.5 (17.1) | 0.63** |
TBF12
| |||||||||||
- total | 5 | 4.6 (4.7) | 65 | 7.4 (4.1) | 236 | 10.0 (4.1) | 234 | 14.2 (4.6) | 70 | 18.7 (4.0) | 0.61** |
- German | 5 | 4.6 (4.7) | 54 | 7.7 (4.2) | 179 | 10.3 (4.0) | 196 | 14.5 (4.5) | 48 | 19.0 (3.8) | 0.61** |
- Dutch | 0 | - | 0 | - | 10 | 10.2 (4.9) | 6 | 15.7 (4.0) | 10 | 18.1 (4.7) | 0.62** |
- Portuguese | 0 | - | 10 | 6.0 (3.7) | 33 | 9.1 (4.1) | 18 | 12.0 (4.0) | 8 | 17.5 (3.8) | 0.58** |
- Spanish | 0 | - | 1 | 5.0 (−) | 14 | 8.4 (4.6) | 14 | 12.2 (5.9) | 4 | 19.0 (5.9) | 0.51** |
TQ
| |||||||||||
- German | 14 | 17.6 (11.2) | 135 | 21.9 (11.3) | 355 | 33.4 (13.9) | 373 | 49.6 (13.3) | 84 | 61.6 (12.1) | 0.68** |
Mini-TQ
| |||||||||||
- German | 13 | 5.6 (4.5) | 128 | 5.8 (3.4) | 344 | 8.9 (4.0) | 363 | 13.5 (3.6) | 80 | 16.4 (3.0) | 0.67** |
TQ 12
| |||||||||||
- German | 13 | 5.5 (4.3) | 132 | 7.5 (4.2) | 342 | 10.7 (4.7) | 366 | 16.0 (4.3) | 81 | 19.3 (3.6) | 0.65** |
Tinnitus severity at final visit | Not a problem | A small problem | A moderate problem | A big problem | A very big problem | Correlation (Spearman) | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
Questionnaire | n | Mean (SD) | n | Mean (SD) | n | r | n | Mean (SD) | n | Mean (SD) | r |
THI
| |||||||||||
- total | 6 | 1.3 (1.6) | 43 | 19.9 (16.4) | 125 | 34.7 (18.8) | 82 | 54.6 (18.0) | 18 | 67.3 (19.5) | 0.65** |
- German | 1 | 0.0 (−) | 16 | 19.4 (14.2) | 79 | 37.0 (19.2) | 64 | 55.0 (17.5) | 14 | 68.3 (19.1) | 0.60** |
- Dutch | 0 | - | 0 | - | 6 | 30.3 (11.8) | 6 | 55.3 (8.8) | 2 | 82.0 (14.1) | 0.92** |
- Portuguese | 5 | 1.6 (1.7) | 27 | 20.2 (17.8) | 27 | 27.2 (15.2) | 9 | 53.1 (26.4) | 2 | 46.0 (11.3) | 0.57** |
- Spanish | 0 | - | 0 | - | 13 | 38.2 (22.8) | 3 | 50.0 (21.1) | 0 | - | 0.21 |
TBF12
| |||||||||||
- total | 5 | 0.2 (0.4) | 41 | 6.6 (5.2) | 123 | 9.4 (4.6) | 79 | 14.6 (4.4) | 18 | 18.8 (3.7) | 0.62** |
- German | 1 | 0.0 (−) | 15 | 7.2 (3.6) | 81 | 10.5 (4.2) | 64 | 15.1 (4.2) | 14 | 18.7 (3.9) | 0.61** |
- Dutch | 0 | - | 0 | - | 6 | 7.7 (5.7) | 6 | 13.2 (2.0) | 2 | 21.5 (2.1) | 0.75** |
- Portuguese | 4 | 0.3 (0.5) | 26 | 6.3 (6.0) | 25 | 6.6 (4.6) | 7 | 12.9 (4.7) | 2 | 16.5 (0.7) | 0.45** |
- Spanish | 0 | - | 0 | - | 11 | 8.6 (4.3) | 2 | 6.0 (1.4) | 0 | - | −0.23 |
TQ
| |||||||||||
- German | 3 | 13.0 (13.5) | 36 | 21.0 (13.6) | 105 | 33.4 (14.3) | 84 | 50.9 (12.5) | 20 | 60.9 (15.7) | 0.67** |
Mini-TQ
| |||||||||||
- German | 3 | 3.3 (4.2) | 35 | 5.4 (3.7) | 105 | 9.1 (4.1) | 83 | 13.7 (3.2) | 20 | 16.1 (3.6) | 0.67** |
TQ 12
| |||||||||||
- German | 3 | 4.3 (5.1) | 34 | 6.6 (4.5) | 105 | 10.8 (4.8) | 82 | 15.9 (3.7) | 20 | 18.7 (4.7) | 0.65** |
Cross-validation of THI and TBF-12
THI/TBF12 | Q1/Q1 | Q2/Q2 | Q3/Q3 | Q8/Q4 | Q9/Q5 | Q10/Q6 | Q13/Q7 | Q15/Q8 | Q17/Q9 | Q18/Q10 | Q22/Q11 | Q23/Q12 | Total |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total (n=667) | 0.67 | 0.72 | 0.47 | 0.49 | 0.76 | 0.64 | 0.72 | 0.76 | 0.75 | 0.55 | 0.68 | 0.50 | 0.85 |
German (n=521) | 0.67 | 0.76 | 0.50 | 0.53 | 0.74 | 0.67 | 0.72 | 0.77 | 0.76 | 0.60 | 0.74 | 0.55 | 0.88 |
Dutch (n=34) | 0.74 | 0.83 | 0.64 | 0.62 | 0.70 | 0.73 | 0.67 | 0.77 | 0.81 | 0.55 | 0.61 | 0.51 | 0.70 |
Portuguese (n=79) | 0.57 | 0.51 | 0.53 | 0.43 | 0.74 | 0.58 | 0.67 | 0.70 | 0.69 | 0.38 | 0.29 | 0.27 | 0.81 |
Spanish (n=33) | 0.76 | 0.66 | 0.44 | 0.14 (n.s.) | 0.67 | 0.47 | 0.64 | 0.63 | 0.57 | 0.52 | 0.83 | 0.51 | 0.78 |
TBF-12, item 12** | ||||
---|---|---|---|---|
THI, item 23* | Never | Sometimes | Often | Total |
No | 103 | 154 | 25 | 282 |
Sometimes | 13 | 166 | 87 | 266 |
Yes | 13 | 29 | 77 | 119 |
Total | 129 | 349 | 189 | 667 |
Sensitivity
PGI-C | Improved | Unchanged | Worsened | ||||||
---|---|---|---|---|---|---|---|---|---|
Questionnaire | n | Mean change (last - base) | SRM | n | Mean change (last - base) | SRM | n | Mean change (last - base) | SRM |
THI
| |||||||||
- total | 126 | 14.46 | 0.89 | 136 | 3.25 | 0.26 | 61 | −3.25 | 0.30 |
- German | 61 | 9.57 | 0.80 | 109 | 1.50 | 0.13 | 55 | −3.67 | 0.35 |
- Dutch | 5 | 8.00 | 0.93 | 7 | 3.71 | 0.45 | 4 | - | - |
- Portuguese | 58 | 20.34 | 1.09 | 19 | 13.37 | 1.05 | 1 | - | - |
- Spanish | 2 | - | - | 1 | - | - | 1 | - | - |
TBF12
| |||||||||
- total | 116 | 2.74 | 0.71 | 132 | 0.23 | 0.08 | 61 | −1.34 | 0.36 |
- German | 59 | 2.05 | 0.59 | 111 | 0.18 | 0.06 | 55 | −1.56 | 0.44 |
- Dutch | 6 | 2.00 | 1.00 | 7 | 0.71 | 0.21 | 4 | - | - |
- Portuguese | 50 | 3.62 | 0.84 | 13 | 0.46 | 0.11 | 1 | - | - |
- Spanish | 1 | - | - | 1 | - | - | 1 | - | - |
TQ
| |||||||||
- German | 86 | 8.72 | 1.04 | 138 | 0.96 | 0.11 | 71 | −3.89 | 0.38 |
Mini-TQ
| |||||||||
- German | 85 | 2.36 | 0.95 | 137 | 0.29 | 0.11 | 70 | −0.80 | 0.30 |
TQ 12
| |||||||||
- German | 83 | 2.83 | 0.94 | 135 | 0.27 | 0.09 | 70 | −1.0 | 0.29 |