Direkt zum Inhalt

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

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

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

Veröffentlichungsdatum dieses Volltextes: 04 Dez 2023 15:23
Artikel
DOI zum Zitieren dieses Dokuments: 10.5283/epub.55157


Zusammenfassung

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 ...

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.



Beteiligte Einrichtungen


Details

DokumentenartArtikel
Titel eines Journals oder einer ZeitschriftTrials
Verlag:BMC
Ort der Veröffentlichung:LONDON
Band:24
Nummer des Zeitschriftenheftes oder des Kapitels:1
Datum24 Juli 2023
InstitutionenMedizin > Lehrstuhl für Hals-Nasen-Ohren-Heilkunde
Medizin > Lehrstuhl für Psychiatrie und Psychotherapie
Identifikationsnummer
WertTyp
10.1186/s13063-023-07303-2DOI
Stichwörter / KeywordsPACKAGE;
Dewey-Dezimal-Klassifikation600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin
StatusVeröffentlicht
BegutachtetJa, diese Version wurde begutachtet
An der Universität Regensburg entstandenJa
URN der UB Regensburgurn:nbn:de:bvb:355-epub-551579
Dokumenten-ID55157

Bibliographische Daten exportieren

Nur für Besitzer und Autoren: Kontrollseite des Eintrags

nach oben