J Psychosom Res. 2012 Aug;73(2):112-21. Epub 2012 Jun 22.
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 JM, Londero A, Martin WH, Mennemeier M, Piccirillo J, De Ridder D, Rupprecht R, Searchfield G, Vanneste S, Zeman F, Langguth B.
Department of Psychiatry and Psychotherapy, University of Regensburg, Germany; Interdisciplinary Tinnitus Clinic, University of Regensburg, Germany.
Consensus On Patient Assessment And Outcome Measurement
Although tinnitus is very common and can be devastating it is a subjective symptom which is very difficult for the clinician or research worker to evaluate and measure. There are probably many categories of tinnitus. There are a wide variety of interventions carried out by speciatlists from a wide range of disciplines. None of the interventions available at present is consistently effective.
There is widespread recognition that consistency between tinnitus research centres in the ways that patients are assessed and outcomes following interventions are measured would facilitate more effective co-operation and more meaningful evaluations and comparisons of outcomes. On the other hand most research centres already have long established systems for collecting and assessing data and hence are unable or unwilling to completely change to a different system because so much would be lost.
At the 1st Tinnitus Research Initiative Meeting in July 2006 an attempt was made through workshops to gain a consensus both for patient assessment and for outcome measurements of what should be regarded as essential, what is highly desirable and what may be helpful. This consensus is within the restrictions of established practice.
The Tinnitus Research Initiative hopes that this consensus will help to assess and compare the various projects it is funding or which it may fund in the future. The Tinnitus Research Initiative hopes this will in turn lead to better cooperation between tinnitus research centres in finding and evaluating treatments for tinnitus.
The consensus document is published in Tinnitus: Pathophysiology and
Treatment and can be referenced as:
Langguth B, Goodey R, Azevedo A et al. Consensus for Tinnitus Patient Assessment and Treatment Outcome Measurement (Tinnitus Research Initiative Meeting. Regensburg. July 2006). Progress in Brain Research, 2007, Vol. 166: Appendix
Case History Questionnaire Dutch Language Version
(translation by Carlijn Hoekstra)
Case History Questionnaire – French Language Version
(translation by Alain Londero)
Case History Questionnaire – German Language Version
(translation by Berthold Langguth)
Case History Questionnaire Italian Language Version
(translation by Stella Forti / Manuela Mazzoli)
Case History Questionnaire – Portuguese Language Version
(translation by Tanit Ganz Sanchez)
Case History Questionnaire – Spanish Language Version
(translation by Ana Belén Elgoyhen, Carlos Herraiz)