Evidence map›Paper›PMID 40111205›Full record

Trial reportOtolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery2025

Estimation of Minimal Clinically Important Difference for Tinnitus Handicap Inventory and Tinnitus Functional Index.

Milena Engelke, Laura Basso, Berthold Langguth, Florian Zeman, Winfried Schlee, Stefan Schoisswohl, Rilana Cima, Dimitris Kikidis, Jose Antonio Lopez-Escamez, Petra Brüggemann and 2 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Notch-induced lateral inhibition compared to standard amplification lateral inhibition therapy for the treatment of chronic tinnitus: A randomised controlled trial.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
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  5. Journal of clinical medicine · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Milena EngelkeDepartment of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.ORCID https://orcid.org/0000-0002-7346-0441
Laura BassoDepartment of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.
Berthold LangguthDepartment of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.
Florian ZemanCenter for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
Winfried SchleeDepartment of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.
Stefan SchoisswohlDepartment of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.
Rilana CimaDepartment of Health Psychology, Katholieke Universiteit Leuven, Leuven, Belgium.
Dimitris KikidisFirst Department of Otorhinolaryngology-Head and Neck Surgery, Hippocrateion General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Jose Antonio Lopez-EscamezDivision of Otolaryngology, Department of Surgery, Instituto de Investigacion Biosanitaria, ibs.GRANADA, Universidad de Granada, Granada, Spain.
Petra BrüggemannTinnitus Center, Charité - Universitätsmedizin Berlin (Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin), Berlin, Germany.
Birgit MazurekTinnitus Center, Charité - Universitätsmedizin Berlin (Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin), Berlin, Germany.
Jorge Piano SimõesDepartment of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe minimal clinically important difference (MCID) represents the smallest change in treatment outcome deemed clinically meaningful. This study estimates the MCID for 2 widely used tinnitus measures: the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI), using anchor-based approaches while accounting for baseline severity and time interval. STUDY

designA multi-center randomized clinical trial.

settingEuropean tinnitus centers.

methodsAnchor-based approaches, including the effect size, receiver-operating characteristics, and ΔTHI/TFI methods, were employed to determine the MCID. The "minimally improved" category of the Clinical Global Impression Scale-Improvement (CGI-I) served as the anchor. The standard error of measurement was used to assess random variation.

resultsFor the THI, MCID estimates ranged from 7.8 to 12, with a point estimate of 11 after 12 weeks of treatment (N = 364). For the TFI, MCID estimates ranged from 7.3 to 9.4, with a point estimate of 9 points after 12 weeks (N = 359). Both measures indicated that higher baseline severity and longer time intervals required greater score reduction for clinical relevance.

conclusionThis study highlights the context-specific nature of MCID values for tinnitus measures and emphasizes the need for consensus on optimal anchor-based approaches to improve comparability.

Indexed as

Disability EvaluationMinimal Clinically Important DifferenceTinnitusAdultAgedFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment Outcomeminimal clinically important differencetinnitusTinnitus Functional IndexTinnitus Handicap Inventory

Identifiers

PMID40111205
PMCPMC12207346

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.