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RESEARCH PRODUCT
Methodological aspects of clinical trials in tinnitus: a proposal for an international standard
Ricardo Rodrigues FigueiredoFlorian ZemanRainer RupprechtSven VannesteWilliam Hal MartinPaul Van De HeyningHerta FlorCarol A. BauerJay F. PiccirilloMark MennemeierJohn L. DornhofferMichael KollerAlain LonderoGoeran HajakAnthony T. CacaceDavid M. BaguleyWolfgang HillerGrant D. SearchfieldDirk De RidderJose Miguel LainezEman M. KhedrMichael LandgrebeBerthold LangguthClaudia CoelhoAndréia Aparecida De AzevedoTobias Kleinjungsubject
Research designmedicine.medical_specialtyAlternative medicineMEDLINE610 Medicine & health10045 Clinic for OtorhinolaryngologyArticleTinnitus2738 Psychiatry and Mental Healthotorhinolaryngologic diseasesMedicineHumansClinical Trials as TopicEvidence-Based Medicinebusiness.industry3203 Clinical PsychologyVariance (accounting)Evidence-based medicineGuidelineClinical trialPsychiatry and Mental healthClinical PsychologyResearch DesignHuman medicinemedicine.symptombusinessTinnitusClinical psychologydescription
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. (c) 2012 Elsevier Inc. All rights reserved.
year | journal | country | edition | language |
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2012-01-01 |