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


Landgrebe, M; Azevedo, A; Baguley, D; Bauer, C; Cacace, A; Coelho, C; Dornhoffer, J; Figueiredo, R; Flor, H; Hajak, G; van de Heyning, P; Hiller, W; Khedr, E; Kleinjung, T; Koller, M; Lainez, J M; Londero, A; Martin, W H; Mennemeier, M; Piccirillo, J; De Ridder, D; Rupprecht, R; Searchfield, G; Vanneste, S; Zeman, F; Langguth, B (2012). Methodological aspects of clinical trials in tinnitus: a proposal for an international standard. Journal of psychosomatic research, 73(2):112-21.

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.

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.

Citations

41 citations in Web of Science®
38 citations in Scopus®
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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Otorhinolaryngology
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2012
Deposited On:20 Sep 2012 08:32
Last Modified:05 Apr 2016 15:57
Publisher:Elsevier Inc.
ISSN:1879-1360
Free access at:Official URL. An embargo period may apply.
Publisher DOI:10.1016/j.jpsychores.2012.05.002
Official URL:http://www.journals.elsevier.com/journal-of-psychosomatic-research/
PubMed ID:22789414

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