Literature DB >> 22789414

Methodological aspects of clinical trials in tinnitus: a proposal for an international standard.

Michael Landgrebe1, Andréia Azevedo, David Baguley, Carol Bauer, Anthony Cacace, Claudia Coelho, John Dornhoffer, Ricardo Figueiredo, Herta Flor, Goeran Hajak, Paul van de Heyning, Wolfgang Hiller, Eman Khedr, Tobias Kleinjung, Michael Koller, Jose Miguel Lainez, Alain Londero, William H Martin, Mark Mennemeier, Jay Piccirillo, Dirk De Ridder, Rainer Rupprecht, Grant Searchfield, Sven Vanneste, Florian Zeman, Berthold Langguth.   

Abstract

Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus.
Copyright © 2012 Elsevier Inc. All rights reserved.

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Year:  2012        PMID: 22789414      PMCID: PMC3897200          DOI: 10.1016/j.jpsychores.2012.05.002

Source DB:  PubMed          Journal:  J Psychosom Res        ISSN: 0022-3999            Impact factor:   3.006


  107 in total

1.  Tinnitus severity measured by a subjective scale, audiometry and clinical judgement.

Authors:  J B Halford; S D Anderson
Journal:  J Laryngol Otol       Date:  1991-02       Impact factor: 1.469

Review 2.  Pharmacological approaches to the treatment of tinnitus.

Authors:  Ana B Elgoyhen; Berthold Langguth
Journal:  Drug Discov Today       Date:  2009-12-02       Impact factor: 7.851

3.  Prevalence and characteristics of tinnitus among US adults.

Authors:  Josef Shargorodsky; Gary C Curhan; Wildon R Farwell
Journal:  Am J Med       Date:  2010-08       Impact factor: 4.965

Review 4.  rTMS for the treatment of tinnitus: the role of neuronavigation for coil positioning.

Authors:  B Langguth; T Kleinjung; M Landgrebe; D de Ridder; G Hajak
Journal:  Neurophysiol Clin       Date:  2009-04-01       Impact factor: 3.734

5.  An in vitro model for testing drugs to treat tinnitus.

Authors:  Calvin Wu; Kamakshi Gopal; Guenter W Gross; Thomas J Lukas; Ernest J Moore
Journal:  Eur J Pharmacol       Date:  2011-06-02       Impact factor: 4.432

Review 6.  Sound therapy (masking) in the management of tinnitus in adults.

Authors:  Jonathan Hobson; Edward Chisholm; Amr El Refaie
Journal:  Cochrane Database Syst Rev       Date:  2010-12-08

Review 7.  Methods to explain the clinical significance of health status measures.

Authors:  Gordon H Guyatt; David Osoba; Albert W Wu; Kathleen W Wyrwich; Geoffrey R Norman
Journal:  Mayo Clin Proc       Date:  2002-04       Impact factor: 7.616

Review 8.  Ringing ears: the neuroscience of tinnitus.

Authors:  Larry E Roberts; Jos J Eggermont; Donald M Caspary; Susan E Shore; Jennifer R Melcher; James A Kaltenbach
Journal:  J Neurosci       Date:  2010-11-10       Impact factor: 6.167

Review 9.  The relevance of spontaneous activity for the coding of the tinnitus sensation.

Authors:  Nathan Weisz; Katalin Dohrmann; Thomas Elbert
Journal:  Prog Brain Res       Date:  2007       Impact factor: 2.453

10.  Transient reduction of tinnitus intensity is marked by concomitant reductions of delta band power.

Authors:  Nina Kahlbrock; Nathan Weisz
Journal:  BMC Biol       Date:  2008-01-16       Impact factor: 7.431

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  60 in total

Review 1.  Evidence and evidence gaps in tinnitus therapy.

Authors:  Gerhard Hesse
Journal:  GMS Curr Top Otorhinolaryngol Head Neck Surg       Date:  2016-12-15

2.  Visual Analogue Scales as a Tool for Initial Assessment of Tinnitus Severity: Psychometric Evaluation in a Clinical Population.

Authors:  Danuta Raj-Koziak; Elzbieta Gos; Weronika Swierniak; Joanna J Rajchel; Lucyna Karpiesz; Iwona Niedzialek; Elzbieta Wlodarczyk; Henryk Skarzynski; Piotr H Skarzynski
Journal:  Audiol Neurootol       Date:  2018-11-15       Impact factor: 1.854

3.  Perceptual Dimensions Underlying Tinnitus-Like Sounds.

Authors:  Jennifer J Lentz; Yuan He
Journal:  J Speech Lang Hear Res       Date:  2020-09-18       Impact factor: 2.297

Review 4.  Tinnitus: perspectives from human neuroimaging.

Authors:  Ana Belén Elgoyhen; Berthold Langguth; Dirk De Ridder; Sven Vanneste
Journal:  Nat Rev Neurosci       Date:  2015-09-16       Impact factor: 34.870

5.  [Chronic complex tinnitus: does day care unit-based short-term psychotherapy help?].

Authors:  G Klug; G Henrich
Journal:  HNO       Date:  2014-12       Impact factor: 1.284

6.  Translation, Cultural Adaptation and Validation to Brazilian Portuguese of the Tinnitus Functional Index Questionnaire.

Authors:  Marine Raquel Diniz da Rosa; Marcelo Yugi Doi; Fátima Cristina Alves Branco-Barreiro; Patricia Simonetti; Jeanne Oiticica; Luciana Lozza de Moraes Marchiori
Journal:  Int Arch Otorhinolaryngol       Date:  2021-08-13

7.  Broadband Amplification as Tinnitus Treatment.

Authors:  Mie Laerkegaard Joergensen; Petteri Hyvärinen; Sueli Caporali; Torsten Dau
Journal:  Brain Sci       Date:  2022-05-31

8.  Dimensional or categorical approach to tinnitus severity: an item response mixture modeling analysis of tinnitus handicap.

Authors:  Hugo Hesser; Gerhard Andersson
Journal:  Int J Behav Med       Date:  2014-12

9.  Improvement in Patient-reported Hearing After Treatment With Bevacizumab in People With Neurofibromatosis Type 2.

Authors:  Victoria Huang; Amanda L Bergner; Chris Halpin; Vanessa L Merker; Monica R Sheridan; Brigitte C Widemann; Jaishri O Blakeley; Scott R Plotkin
Journal:  Otol Neurotol       Date:  2018-06       Impact factor: 2.311

10.  One Size Does Not Fit All: Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults.

Authors:  Deborah A Hall; Alice Hibbert; Harriet Smith; Haúla F Haider; Alain Londero; Birgit Mazurek; Kathryn Fackrell
Journal:  Trends Hear       Date:  2019 Jan-Dec       Impact factor: 3.293

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