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

Autor: Simoes JP; Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany. jorge.simoes@ukr.de.; Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands. jorge.simoes@ukr.de., Schoisswohl S; Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.; Department of Psychology, Universität der Bundeswehr München, Neubiberg, Germany., Schlee W; Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.; Institute for Information and Process Management, Eastern Switzerland University of Applied Sciences, St. Gallen, Switzerland., Basso L; Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany., Bernal-Robledano A; Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada, 18014, Granada, Spain., Boecking B; Tinnitus Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin, Charitéplatz 1, 10117, Berlin, Germany., Cima R; Health Psychology, Faculty of Psychology and Educational Sciences, KU Leuven University, Leuven, Belgium.; Tinnitus Center of Expertise, Centre of Expertise in Rehabilitation and Audiology, Adelante, Hoensbroek, The Netherlands.; Experimental Health Psychology, Faculty of Psychology and Neurosciences, Maastricht University, Maastricht, The Netherlands., Denys S; Research group Experimental Otorhinolaryngology (ExpORL), Department of Neurosciences, KU Leuven University, Leuven, Belgium.; Department of Otorhinolaryngology, Head and Neck surgery, University Hospitals of Leuven, Leuven, Belgium., Engelke M; Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany., Escalera-Balsera A; Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada, 18014, Granada, Spain.; Otology & Neurotology Group CTS 495, Department of Genomic Medicine, GENYO, Center for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, Granada, Spain., Gallego-Martinez A; Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada, 18014, Granada, Spain.; Otology & Neurotology Group CTS 495, Department of Genomic Medicine, GENYO, Center for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, Granada, Spain., Gallus S; Istituto Di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy., Kikidis D; Department of Otorhinolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Medical School, Athens, Greece., López-Escámez JA; Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada, 18014, Granada, Spain.; Otology & Neurotology Group CTS 495, Department of Genomic Medicine, GENYO, Center for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, Granada, Spain.; Department of Surgery, Division of Otolaryngology, Faculty of Medicine, University of Granada, Granada, Spain.; Meniere's Disease Neuroscience Research Program, Faculty of Medicine & Health, School of Medical Sciences, The Kolling Institute, University of Sydney, Sydney, New South Wales, Australia., Marcrum SC; Department of Otolaryngology, University Hospital Regensburg, Regensburg, Germany., Markatos N; Department of Otorhinolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Medical School, Athens, Greece., Martin-Lagos J; Department of Otolaryngology, Instituto de Investigacion Biosanitaria Granada, ibs.GRANADA, Hospital Universitario San Cecilio, Granada, Spain., Martinez-Martinez M; Department of Otolaryngology, Instituto de Investigacion Biosanitaria Granada, ibs.GRANADA, Hospital Universitario San Cecilio, Granada, Spain., Mazurek B; Tinnitus Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin, Charitéplatz 1, 10117, Berlin, Germany., Vassou E; Department of Otorhinolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Medical School, Athens, Greece., Jarach CM; Istituto Di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy., Mueller-Locatelli N; Department of Otolaryngology, Instituto de Investigacion Biosanitaria Granada, ibs.GRANADA, Hospital Universitario San Cecilio, Granada, Spain., Neff P; Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.; Department of Otorhinolaryngology, Head & Neck Surgery, University Hospital Zurich, University of Zurich, Zurich, Switzerland.; Neuro-X Institute, École Polytechnique Fédérale de Lausanne (EPFL), Geneva, Switzerland.; Centre for Cognitive Neuroscience, University of Salzburg, Salzburg, Austria., Niemann U; Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg, Magdeburg, Germany., Omar HK; Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg, Magdeburg, Germany., Puga C; Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg, Magdeburg, Germany., Schleicher M; Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg, Magdeburg, Germany., Unnikrishnan V; Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg, Magdeburg, Germany., Perez-Carpena P; Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada, 18014, Granada, Spain.; Otology & Neurotology Group CTS 495, Department of Genomic Medicine, GENYO, Center for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, Granada, Spain., Pryss R; Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany., Robles-Bolivar P; Department of Otolaryngology, Instituto de Investigación Biosanitaria ibs.Granada, Hospital Universitario Virgen de Las Nieves, Universidad de Granada, 18014, Granada, Spain.; Otology & Neurotology Group CTS 495, Department of Genomic Medicine, GENYO, Center for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, Granada, Spain., Rose M; Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin, Berlin, Germany., Schecklmann M; Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany., Schiele T; Tinnitus Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin, Charitéplatz 1, 10117, Berlin, Germany., Schobel J; Institute DigiHealth, University of Applied Sciences, Neu-Ulm, Germany., Spiliopoulou M; Knowledge Management and Discovery Lab (KMD), Faculty of Computer Science, Otto Von Guericke University Magdeburg, Magdeburg, Germany., Stark S; Tinnitus Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin, Charitéplatz 1, 10117, Berlin, Germany., Vogel C; Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany., Wunder N; Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany., Zachou Z; Department of Otorhinolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Medical School, Athens, Greece., Langguth B; Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Jul 24; Vol. 24 (1), pp. 472. Date of Electronic Publication: 2023 Jul 24.
DOI: 10.1186/s13063-023-07303-2
Abstrakt: 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.
(© 2023. The Author(s).)
Databáze: MEDLINE
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