TY - JOUR
T1 - The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT)
AU - Simoes, Jorge Piano
AU - Schoisswohl, Stefan
AU - Schlee, Winfried
AU - Basso, Laura
AU - Bernal-Robledano, Alberto
AU - Boecking, Benjamin
AU - Cima, Rilana
AU - Denys, Sam
AU - Engelke, Milena
AU - Escalera-Balsera, Alba
AU - Gallego-Martinez, Alvaro
AU - Gallus, Silvano
AU - Kikidis, Dimitris
AU - Lopez-Escamez, Jose A. A.
AU - Marcrum, Steven C. C.
AU - Markatos, Nikolaos
AU - Martin-Lagos, Juan
AU - Martinez-Martinez, Marta
AU - Mazurek, Birgit
AU - Vassou, Evgenia
AU - Jarach, Carlotta Micaela
AU - Mueller-Locatelli, Nicolas
AU - Neff, Patrick
AU - Niemann, Uli
AU - Omar, Hafez Kader
AU - Puga, Clara
AU - Schleicher, Miro
AU - Unnikrishnan, Vishnu
AU - Perez-Carpena, Patricia
AU - Pryss, Ruediger
AU - Robles-Bolivar, Paula
AU - Rose, Matthias
AU - Schecklmann, Martin
AU - Schiele, Tabea
AU - Schobel, Johannes
AU - Spiliopoulou, Myra
AU - Stark, Sabine
AU - Vogel, Carsten
AU - Wunder, Nina
AU - Zachou, Zoi
AU - Langguth, Berthold
PY - 2023/7/24
Y1 - 2023/7/24
N2 - 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.
AB - 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.
KW - PACKAGE
U2 - 10.1186/s13063-023-07303-2
DO - 10.1186/s13063-023-07303-2
M3 - Article
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
IS - 1
M1 - 472
ER -