Methodological Aspects of Randomized Controlled Trials for Tinnitus: A Systematic Review and How a Decision Support System Could Overcome Barriers

Abstract

Although a wide range of tinnitus management interventions is currently under research and a variety of therapeutic interventions have already been applied in clinical practice, no optimal and universal tinnitus treatment has been reached yet. This fact is to some extent a consequence of the high heterogeneity of the methodologies used in tinnitus related clinical studies. In this manuscript, we have identified, summarized, and critically appraised tinnitus-related randomized clinical trials since 2010, aiming at systematically mapping the research conducted in this area. The results of our analysis of the 73 included randomized clinical trials provide important insight on the identification of limitations of previous works, methodological pitfalls or gaps in current knowledge, a prerequisite for the adequate interpretation of current literature and execution of future studies.

Unification of treatments and interventions for tinnitus patients (UNITI): a study protocol for a multi-center randomized clinical trial

“…Furthermore, the UNITI-RCT attempts to overcome essential limitations of previous studies [20,21] through a large sample size, harmonized patient selection and screening processes across the ve participating clinical centers, standardized assessments methods and interventions across the clinical sites, as well as large-scale data analysis strategies. Previous reviews of tinnitus treatments provide evidence that only three past RCTs exceed 250 participants [23], to the best of our knowledge the currently largest RCT included 492 patients [18].…”

“…Up to now, cognitive behavioral therapy approaches exhibit the best body of evidence for the treatment of tinnitus [18,19] with a strong recommendation according to European guidelines [17]. Even though tinnitus research has been impressively expanded over the past decade, the majority of studies suffers from methodological shortcomings such as heterogeneous patient samples, imprecisely de ned therapeutic interventions, relatively small sample sizes as well as a lack of prede ned primary outcomes and data analysis strategies [20,21]. Beyond tackling these limitations in prospective studies, interdisciplinary multi-center randomized clinical trials (RCT) could help to further increase the validity and interpretability of results.…”

“…A potential proceeding would be the identi cation of demographic or tinnitus-related characteristics, potentially capable to predict a patients response to a certain type of intervention [26]. Such predictive markers could facilitate a so-called Decision Support System (DSS), which could assist clinicians in selecting the most promising tinnitus treatment on an individual patient level [20].…”

Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial

“…Up to now, cognitive behavioral therapy approaches exhibit the best body of evidence for the treatment of tinnitus [ 18 , 19 ] with a strong recommendation according to European guidelines [ 17 ]. Even though tinnitus research has been impressively expanded over the past decade, the majority of studies suffers from methodological shortcomings such as heterogeneous patient samples, imprecisely defined therapeutic interventions, relatively small sample sizes, and a lack of predefined primary outcomes and data analysis strategies [ 20 , 21 ]. Beyond tackling these limitations in prospective studies, interdisciplinary multi-center randomized clinical trials (RCT) could help to further increase the validity and interpretability of results.…”

“…A potential proceeding would be the identification of demographic or tinnitus-related characteristics, potentially capable to predict a patient’s response to a certain type of intervention [ 26 ]. Such predictive markers could facilitate a so-called Decision Support System (DSS), which could assist clinicians in selecting the most promising tinnitus treatment on an individual patient level [ 20 ].…”