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

Michael Landgrebe; 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

doi:10.1016/j.jpsychores.2012.05.002

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

Michael Landgrebe, 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 PiccirilloDirk De Ridder, Rainer Rupprecht, Grant Searchfield, Sven Vanneste, Florian Zeman, Berthold Langguth

Otolaryngology

Research output: Contribution to journal › Article › peer-review

134 Scopus citations

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.

Original language	English (US)
Pages (from-to)	112-121
Number of pages	10
Journal	Journal of Psychosomatic Research
Volume	73
Issue number	2
DOIs	https://doi.org/10.1016/j.jpsychores.2012.05.002
State	Published - Aug 2012

Keywords

Clinical trials
Guideline
Tinnitus
Trial methodology

ASJC Scopus subject areas

Clinical Psychology
Psychiatry and Mental health

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10.1016/j.jpsychores.2012.05.002

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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., ... Langguth, B. (2012). Methodological aspects of clinical trials in tinnitus: A proposal for an international standard. Journal of Psychosomatic Research, 73(2), 112-121. https://doi.org/10.1016/j.jpsychores.2012.05.002

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, JM, Londero, A, Martin, WH, 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, vol. 73, no. 2, pp. 112-121. https://doi.org/10.1016/j.jpsychores.2012.05.002

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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.",

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AU - Dornhoffer, John

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AU - Hiller, Wolfgang

AU - Khedr, Eman

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AU - Koller, Michael

AU - Lainez, Jose Miguel

AU - Londero, Alain

AU - Martin, William H.

AU - Mennemeier, Mark

AU - Piccirillo, Jay

AU - De Ridder, Dirk

AU - Rupprecht, Rainer

AU - Searchfield, Grant

AU - Vanneste, Sven

AU - Zeman, Florian

AU - Langguth, Berthold

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AB - 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.

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

Abstract

Keywords

ASJC Scopus subject areas

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