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Table 3 Summary of all primary and secondary outcome domains across all 228 clinical trials. Domains have been grouped according to eight major topic categories. Categories 1–5 relate to different types of ‘patient outcomes’, categories 6–7 relate to ‘adverse events’ and ‘satisfaction’, following the Effective Practice and Organisation of Care classification scheme [22]. Categories 8 and 9 best describe the remaining outcomes reported in the included records. Percentages are rounded so, for example, 0 % denotes a value that is <0.5 %

From: Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

 

Primary domains

Secondary domains

 

Number

Percentage (%)

Number

Percentage (%)

(1) Domains relating to the tinnitus percept:

 Tinnitus loudness

70

14 %

42

7 %

 Tinnitus pitch

12

2 %

13

2 %

(2) Domains relating to the impact of tinnitus:

 Tinnitus distress

33

7 %

18

3 %

 Tinnitus annoyance

22

4 %

15

3 %

 Tinnitus awareness

10

2 %

2

0 %

 Cognition

2

0 %

4

1 %

 Behaviour

1

0 %

0

-

 Acceptance of tinnitus

0

-

3

1 %

 Catastrophising

0

-

1

0 %

 Concentration

0

-

2

0 %

 Tinnitus intrusiveness

0

-

2

0 %

 Tinnitus-related cognitions

0

-

1

0 %

 Tinnitus-related fear

0

-

1

0 %

(3) Other co-occurring complaints:

 Depression

8

2 %

18

3 %

 General distress

5

1 %

5

1 %

 Anxiety

4

1 %

6

1 %

 Anxiety and depression

4

1 %

13

2 %

 Hearing threshold

4

1 %

11

2 %

 Hearing loss

2

0 %

1

0 %

 Speech perception

2

0 %

0

-

 Hearing handicap

1

0 %

3

1 %

 Hearing loss annoyance

1

0 %

0

-

 Sleep quality

1

0 %

12

2 %

 Somatic sensations

1

0 %

1

0 %

 Fear (anxiety)

0

-

1

0 %

 Hyperacusis

0

-

3

1 %

 Mood

0

-

2

0 %

 Sound tolerance

0

-

1

0 %

 Speech discrimination

0

-

3

1 %

(4) Health-related quality of life (QoL):

 QoL (tinnitus)

16

3 %

13

2 %

 QoL

9

2 %

20

3 %

 Coping

3

1 %

0

-

 Occupational health

0

-

1

0 %

 QoL (hearing)

0

-

1

0 %

 Sense of control

0

-

1

0 %

(5) Body structures and functions:

 Neck mobility

1

0 %

1

0 %

 Neural activity

1

0 %

2

0 %

 Oxidative stress

1

0 %

0

-

 Active myofascial trigger points

0

-

1

0 %

 Blood parameters

0

-

1

0 %

 Gene expression

0

-

1

0 %

 Metabolism

0

-

4

1 %

 Neck pain

0

-

1

0 %

 Neuroendocrine hormones

0

-

1

0 %

 Pharmacokinetics

0

-

1

0 %

 Structural brain change

0

-

1

0 %

(6) Adverse events or harms:

 Safety and tolerability

6

1 %

4

1 %

 Safety

2

0 %

43

7 %

 Drug safety and tolerability

1

0 %

4

1 %

 Side effects

1

0 %

15

3 %

 Headache

0

-

1

0 %

 Pain frequency

0

-

1

0 %

 Pain intensity

0

-

1

0 %

(7) Satisfaction:

 Treatment satisfaction

1

0 %

5

1 %

(8) Treatment-related outcomes:

 Withdrawals

1

0 %

0

-

 Adequacy of blinding

0

-

1

0 %

 Credibility (sham)

0

-

1

0 %

 Credibility (treatment)

0

-

2

0 %

 Needling sensation (acupuncture)

0

-

1

0 %

 Therapeutic alliance

0

-

1

0 %

 Tolerability

0

-

5

1 %

(9) Domain of interest unclear or not specified by the authors:

 Not specified

128

25 %

140

24 %

 Cannot code

58

11 %

76

13 %

 Multi-domain specification

10

2 %

10

2 %

 Tinnitus severity

69

14 %

29

5 %

 Tinnitus handicap

14

3 %

5

1 %

Total

505

100 %

579

100 %