Journal Article

The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT)

Vassou, Evgenia, Pryss, Rüdiger, Spiliopoulou, Myra, Rose, Matthias, Schiele, Tabea, Schlee, Winfried, Stark, Sabine, Zachou, Zoi, Jarach, Carlotta Micaela, Omar, Hafez Kader, Gallus, Silvano, Martinez-Martinez, Marta, Schoisswohl, Stefan, Martin-Lagos, Juan, Niemann, Uli, Langguth, Berthold, Bernal-Robledano, Alberto, Engelke, Milena, Perez-Carpena, Patricia, Markatos, Nikolaos, Schleicher, Miro, Schecklmann, Martin, Escalera-Balsera, Alba, López-Escámez, Jose A., Puga, Clara, Unnikrishnan, Vishnu, Marcrum, Steven C., Mazurek, Birgit, Mueller-Locatelli, Nicolas, Denys, Sam, Neff, Patrick, Wunder, Nina, Cima, Rilana, Gallego-Martinez, Alvaro, Schobel, Johannes, Basso, Laura, Kikidis, Dimitris, Robles-Bolivar, Paula, Boecking, Benjamin, Simoes, Jorge Piano, Vogel, Carsten

2023

Overview

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. Trial registration ClinicalTrials.gov NCT04663828 . The trial is ongoing. Date of registration: December 11, 2020. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Anesthetics, Local / Behavior modification / Behavioral health care / Biomedicine / Brain research / Care and treatment / Clinical trials / Cognition & reasoning / Cognitive Behavioral Therapy / Cognitive therapy / Combined Modality Therapy / Counseling / Data analysis / Decision support systems / Diagnosis / Drug therapy / Europe / Health Sciences / Hearing aids / Humans / Intervention / Medicine / Medicine & Public Health / Methods / Music therapy / Nervous system / Objectives / Patient outcomes / Patients / Questionnaires / Statistical analysis / Statistics for Life Sciences / Tinnitus / Update