Simoes, Jorge Piano and Schoisswohl, Stefan and Schlee, Winfried and Basso, Laura and Bernal-Robledano, Alberto and Boecking, Benjamin and Cima, Rilana and Denys, Sam and Engelke, Milena and Escalera-Balsera, Alba and Gallego-Martinez, Alvaro and Gallus, Silvano and Kikidis, Dimitris and Lopez-Escamez, Jose A. A. and Marcrum, Steven C. C. and Markatos, Nikolaos and Martin-Lagos, Juan and Martinez-Martinez, Marta and Mazurek, Birgit and Vassou, Evgenia and Jarach, Carlotta Micaela and Mueller-Locatelli, Nicolas and Neff, Patrick and Niemann, Uli and Omar, Hafez Kader and Puga, Clara and Schleicher, Miro and Unnikrishnan, Vishnu and Perez-Carpena, Patricia and Pryss, Ruediger and Robles-Bolivar, Paula and Rose, Matthias and Schecklmann, Martin and Schiele, Tabea and Schobel, Johannes and Spiliopoulou, Myra and Stark, Sabine and Vogel, Carsten and Wunder, Nina and Zachou, Zoi and Langguth, Berthold (2023) The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT). TRIALS, 24 (1): 472. ISSN , 1745-6215
Full text not available from this repository. (Request a copy)Abstract
Background Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potentially increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. Methods Within the Unification of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavioral therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in four treatment arms with single treatment and six treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. Discussion The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PACKAGE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Hals-Nasen-Ohren-Heilkunde Medicine > Lehrstuhl für Psychiatrie und Psychotherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 23 Mar 2024 13:23 |
| Last Modified: | 23 Mar 2024 13:23 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60494 |
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