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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 %