PMID- 38002730
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231128
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 12
IP  - 22
DP  - 2023 Nov 15
TI  - Minimal Clinically Important Difference of Tinnitus Outcome Measurement 
      Instruments-A Scoping Review.
LID - 10.3390/jcm12227117 [doi]
LID - 7117
AB  - OBJECTIVE: Tinnitus assessment and outcome measurement are complex, as tinnitus 
      is a purely subjective phenomenon. Instruments used for the outcome measurement 
      of tinnitus in the context of clinical trials include self-report questionnaires, 
      visual analogue or numeric rating scales and psychoacoustic measurements of 
      tinnitus loudness. For the evaluation of therapeutic interventions, it is 
      critical to know which changes in outcome measurement instruments can be 
      considered as clinically relevant. For this purpose, the concept of the minimal 
      clinically important difference (MCID) has been introduced. STUDY DESIGN: Here we 
      performed a literature research in PubMed in order to identify for which tinnitus 
      outcome measurements MCID criteria have been estimated and which of these 
      estimates fulfil the current methodological standards and can thus be considered 
      as established. RESULTS: For most, but not all tinnitus outcome instruments, MCID 
      calculations have been performed. The MCIDs for the Tinnitus Handicap Inventory 
      (THI), the Tinnitus Questionnaire (TQ), the Tinnitus Functional Index (TFI) and 
      visual analogue scales (VAS) vary considerably across studies. Psychoacoustic 
      assessments of tinnitus such as loudness matching have not shown sufficient 
      reliability and validity for the use as an outcome measurement. CONCLUSION: 
      Future research should aim at the confirmation of the available estimates in 
      large samples involving various therapeutic interventions and under the 
      consideration of time intervals and baseline values. As a rule of thumb, an 
      improvement of about 15% can be considered clinically meaningful, analogous to 
      what has been seen in other entirely subjective pathologies like chronic pain.
FAU - Langguth, Berthold
AU  - Langguth B
AD  - Department of Psychiatry and Psychotherapy, Bezirksklinikum, University of 
      Regensburg, 93053 Regensburg, Germany.
FAU - De Ridder, Dirk
AU  - De Ridder D
AD  - Section of Neurosurgery, Department of Surgical Sciences, Dunedin School of 
      Medicine, University of Otago, Dunedin 9054, New Zealand.
LA  - eng
GR  - not known/University of Regensburg/
PT  - Journal Article
PT  - Review
DEP - 20231115
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC10671865
OTO - NOTNLM
OT  - anchor-based method
OT  - clinical trial
OT  - distribution-based method
OT  - minimal clinically important difference
OT  - minimal detectable change
OT  - patient reported outcome
COIS- BL received honoraria for consultancy and speakers' fees from ANM, AstraZeneca, 
      Autifony Therapeutics, Decibel Therapeutics, Desyncra, Gerson Lehmanns Group, 
      Lundbeck, Merz, MagVenture, Medical Tribune, Neurolite, Neuromod, Novartis, 
      Pfizer, Rovi, Schwabe, Sea Pharma, Servier, Sonova and Sound Therapeutics; 
      research funding from the Tinnitus Research Initiative, Bayhost, the German 
      Research Foundation, the German Bundesministerium fur Bildung und Forschung, the 
      American Tinnitus Association, AstraZeneca, cerbomed, Neuromod and the European 
      Commission under the Horizon 2020 Research and Inmnovation Programme; funding for 
      equipment from MagVenture and Deymed Diagnostic; and travel and accommodation 
      payments from Eli Lilly, Lundbeck, Servier, and Pfizer. He owns shares of Sea 
      Pharma. None of the funding sources are in relation with this article. DDR is on 
      the speaker's bureau, advisory board and consultant for Abbott, Qey, Elexo and 
      Neurosoft bio, but none related to the topic of this manuscript.
EDAT- 2023/11/25 12:47
MHDA- 2023/11/25 12:48
PMCR- 2023/11/15
CRDT- 2023/11/25 01:11
PHST- 2023/10/29 00:00 [received]
PHST- 2023/11/10 00:00 [revised]
PHST- 2023/11/13 00:00 [accepted]
PHST- 2023/11/25 12:48 [medline]
PHST- 2023/11/25 12:47 [pubmed]
PHST- 2023/11/25 01:11 [entrez]
PHST- 2023/11/15 00:00 [pmc-release]
AID - jcm12227117 [pii]
AID - jcm-12-07117 [pii]
AID - 10.3390/jcm12227117 [doi]
PST - epublish
SO  - J Clin Med. 2023 Nov 15;12(22):7117. doi: 10.3390/jcm12227117.