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Open Access Study protocol

Cost-effectiveness of multidisciplinary management of Tinnitus at a specialized Tinnitus centre

Rilana Cima1*, Manuela Joore2, Iris Maes2, Dyon Scheyen3, Amr El Refaie4, David M Baguley5, Johan WS Vlaeyen16 and Lucien Anteunis7

Author Affiliations

1 Clinical Psychological Science, Maastricht University, Maastricht, The Netherlands

2 Department of Clinical Epidemiology and Medical Technology Assessment, University Hospital Maastricht, Maastricht, The Netherlands

3 Rehabilitation Foundation Limburg, Hoensbroek, The Netherlands

4 Access and Communication Studies, Bristol University, Bristol, UK

5 Departments of Otolaryngology and Audiology, Addenbrooke's Hospital, Hills Road, Cambridge, UK

6 Department of Psychology, University of Leuven, Leuven, Belgium

7 Department of Otorhinolaryngology & Head and Neck Surgery, University Hospital Maastricht, Maastricht, The Netherlands

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BMC Health Services Research 2009, 9:29  doi:10.1186/1472-6963-9-29

Published: 11 February 2009

Abstract

Background

Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus, quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests that a comprehensive multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of a comprehensive treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol.

Methods/Design

In a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus sufferers referred to the audiological centre are eligible. Included patients will be followed for 12 months. Primary outcome measure is generic quality of life (measured with the Health Utilities Index Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the number of patients to include is 198. Economic evaluation will be performed from a societal perspective.

Discussion

This is, to our knowledge, the first randomized controlled trial that evaluates a comprehensive treatment of tinnitus and includes a full economic evaluation from a societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated.

Trial Registration

The trial has been registered at ClinicalTrial.gov. The trial registration number is NCT00733044