Trials (Jul 2023)
The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT)
- Jorge Piano Simoes,
- Stefan Schoisswohl,
- Winfried Schlee,
- Laura Basso,
- Alberto Bernal-Robledano,
- Benjamin Boecking,
- Rilana Cima,
- Sam Denys,
- Milena Engelke,
- Alba Escalera-Balsera,
- Alvaro Gallego-Martinez,
- Silvano Gallus,
- Dimitris Kikidis,
- Jose A. López-Escámez,
- Steven C. Marcrum,
- Nikolaos Markatos,
- Juan Martin-Lagos,
- Marta Martinez-Martinez,
- Birgit Mazurek,
- Evgenia Vassou,
- Carlotta Micaela Jarach,
- Nicolas Mueller-Locatelli,
- Patrick Neff,
- Uli Niemann,
- Hafez Kader Omar,
- Clara Puga,
- Miro Schleicher,
- Vishnu Unnikrishnan,
- Patricia Perez-Carpena,
- Rüdiger Pryss,
- Paula Robles-Bolivar,
- Matthias Rose,
- Martin Schecklmann,
- Tabea Schiele,
- Johannes Schobel,
- Myra Spiliopoulou,
- Sabine Stark,
- Carsten Vogel,
- Nina Wunder,
- Zoi Zachou,
- Berthold Langguth
Affiliations
- Jorge Piano Simoes
- Department of Psychiatry and Psychotherapy, University of Regensburg
- Stefan Schoisswohl
- Department of Psychiatry and Psychotherapy, University of Regensburg
- Winfried Schlee
- Department of Psychiatry and Psychotherapy, University of Regensburg
- Laura Basso
- Department of Psychiatry and Psychotherapy, University of Regensburg
- Alberto Bernal-Robledano
- Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada
- Benjamin Boecking
- Tinnitus Center, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin
- Rilana Cima
- Health Psychology, Faculty of Psychology and Educational Sciences, KU Leuven University
- Sam Denys
- Research group Experimental Otorhinolaryngology (ExpORL), Department of Neurosciences, KU Leuven University
- Milena Engelke
- Department of Psychiatry and Psychotherapy, University of Regensburg
- Alba Escalera-Balsera
- Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada
- Alvaro Gallego-Martinez
- Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada
- Silvano Gallus
- Istituto Di Ricerche Farmacologiche Mario Negri IRCCS
- Dimitris Kikidis
- Department of Otorhinolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Medical School
- Jose A. López-Escámez
- Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada
- Steven C. Marcrum
- Department of Otolaryngology, University Hospital Regensburg
- Nikolaos Markatos
- Department of Otorhinolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Medical School
- Juan Martin-Lagos
- Department of Otolaryngology, Instituto de Investigacion Biosanitaria Granada, ibs.GRANADA, Hospital Universitario San Cecilio
- Marta Martinez-Martinez
- Department of Otolaryngology, Instituto de Investigacion Biosanitaria Granada, ibs.GRANADA, Hospital Universitario San Cecilio
- Birgit Mazurek
- Tinnitus Center, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin
- Evgenia Vassou
- Department of Otorhinolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Medical School
- Carlotta Micaela Jarach
- Istituto Di Ricerche Farmacologiche Mario Negri IRCCS
- Nicolas Mueller-Locatelli
- Department of Otolaryngology, Instituto de Investigacion Biosanitaria Granada, ibs.GRANADA, Hospital Universitario San Cecilio
- Patrick Neff
- Department of Psychiatry and Psychotherapy, University of Regensburg
- Uli Niemann
- Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg
- Hafez Kader Omar
- Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg
- Clara Puga
- Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg
- Miro Schleicher
- Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg
- Vishnu Unnikrishnan
- Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg
- Patricia Perez-Carpena
- Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada
- Rüdiger Pryss
- Institute of Clinical Epidemiology and Biometry, University of Würzburg
- Paula Robles-Bolivar
- Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada
- Matthias Rose
- Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin
- Martin Schecklmann
- Department of Psychiatry and Psychotherapy, University of Regensburg
- Tabea Schiele
- Tinnitus Center, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin
- Johannes Schobel
- Institute DigiHealth, University of Applied Sciences
- Myra Spiliopoulou
- Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg
- Sabine Stark
- Tinnitus Center, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin
- Carsten Vogel
- Institute of Clinical Epidemiology and Biometry, University of Würzburg
- Nina Wunder
- Department of Psychiatry and Psychotherapy, University of Regensburg
- Zoi Zachou
- Department of Otorhinolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Medical School
- Berthold Langguth
- Department of Psychiatry and Psychotherapy, University of Regensburg
- DOI
- https://doi.org/10.1186/s13063-023-07303-2
- Journal volume & issue
-
Vol. 24,
no. 1
pp. 1 – 13
Abstract
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. 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.
