Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre
Brief Summary: 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 an integral multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of an integral 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 from a societal perspective.

Discussion/ Conclusion: This is, to our knowledge, the first randomized controlled trial that evaluates an integral treatment of tinnitus that 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.


Options:
A: Inclusion Criteria:

* Mentally healthy people
* Chronic tonal Tinnitus
* Older than 18 years
* Signature of the patient informed consent
* No participation in other tinnitus therapy during the clinical investigation

Exclusion Criteria:

* A necessity for hearing aid
* Auditory hallucination
* Symptomatic hearing disorders
* "Morbus Meniere",
* Tinnitus due to temporomandibular joint disorders
* Subjects who can't perceive therapeutic tones
* Brainstem diseases
* Psychiatric disorders
* Objective Tinnitus
* Insufficient treatment of general disorders, anemia, tumor, dialysis, hypertonus ect.
B: Inclusion Criteria:

* Subjective tinnitus complaints
* Referred to Tinnitus centre Limburg

Exclusion Criteria:

* Not being able to write and read in Dutch
C: Inclusion Criteria:

* Age of at least 18 years
* Chronic tinnitus for at least 6 months
* Medical examination of tinnitus by an ear, nose and throat physician (ENT)
* Scoring 38 or above on the Tinnitus Handicap Inventory (THI) or scoring 13 or above on the Mini-Tinnitus Questionnaire (Mini-TQ)
* Not currently receiving psychological treatment for tinnitus
* Being able to access the Internet and print instructions
* Sufficient knowledge of the German language to read and follow the Internet-based self-help program

Exclusion Criteria:

* Tinnitus caused by any other general medical condition or otologic disease (e.g., active Meniere's Disease)
* Clinical diagnosis of any severe mental disorder (especially a severe depressive disorder, suicidality, acute psychosis)
* Clinical diagnosis of Dementia or another severe organic cerebral disorder
* Clinical diagnosis of substance-related addiction/abuse
D: Inclusion Criteria:

* Chronic tinnitus (duration ≥ 6 months)
* German speaking
* Subjective tinnitus

Exclusion Criteria:

* Instable medical conditions
* Objective tinnitus

Answer: B