von Sherezade Moñino‐Romero ; Pavel Kolkhir ; Zsolt Szépfalusi ; Nicole Schoepke ; Martin Metz ; Riccardo Asero ; Marta Ferrer ; Ana M. Giménez Arnau ; Clive E. H. Grattan ; Thilo Jakob ; George N. Konstantinou ; Ulrike Raap ; Petra Staubach-Renz ; Ke Zhang ; Carsten Bindslev-Jensen ; Alvaro Daschner ; Tamar Kinaciyan ; Michael Makris ; Nadine Marrouche ; Peter Schmid-Grendelmeier ; Gordon Sussman ; Elias Toubi ; Marcus Maurer ; Sabine Altrichter
von Sonja K. Eilts ; Johanna M. Pfeil ; Broder Poschkamp ; Tim Ulrich Krohne ; Nicole Eter ; Teresa Barth ; Rainer Guthoff ; Wolf A. Lagrèze ; Milena Grundel ; Marie-Christine Bründer ; Martin Busch ; Jayashree Kalpathy-Cramer ; Michael F. Chiang ; R. V. Paul Chan ; Aaron S. Coyner ; Susan Ostmo ; Peter Campbell ; Andreas Stahl ; Stefan Schrader
von Marcio Roberto Pie ; Fernanda S. Caron ; Thom Dallimore ; Helena J. R. Einzmann ; Peter Hietz ; Michael Kessler ; Flavio Nunes Ramos ; João Pedro Costa Elias ; Holger Kreft ; Thorsten Krömer ; Maria Judith Carmona Higuita ; Daniel Zuleta ; Giesta Machado ; André Luís de Gasper ; Gerhard Zotz ; Glenda Mendieta-Leiva ; Derio Antonio Jimenez-Lopez ; Alex Fernando Mendes ; Pedro Brancalion ; Sara Mortara ; Christopher Thomas Blum ; Mariana Victória Irume ; Nayely Martínez-Meléndez Nayely ; Ana Maria Benavides ; Carlos Renato Boelter ; Sven Batke
von Thomas van Essen ; Inge A. M. van Erp ; Hester F. Lingsma ; Dana Pisică ; John K. Yue ; Ranjit D. Singh ; Jeroen T. J. M. van Dijck ; Victor Volovici ; Alexander Younsi ; Angelos Kolias ; Lianne D. Peppel ; Majanka Heijenbrok-Kal ; Gerard M. Ribbers ; David K. Menon ; Peter J. A. Hutchinson ; Geoffrey T. Manley ; Bart Depreitere ; Ewout W. Steyerberg ; Andrew I. R. Maas ; Godard C. W. de Ruiter ; Wilco C. Peul ; Renán Sánchez-Porras
Background - Limited evidence existed on the comparative effectiveness of decompressive craniectomy (DC) versus craniotomy for evacuation of traumatic acute subdural hematoma (ASDH) until the recently published randomised clinical trial RESCUE-ASDH. In this study, that ran concurrently, we aimed to determine current practice patterns and compare outcomes of primary DC versus craniotomy. - Methods - We conducted an analysis of centre treatment preference within the prospective, multicentre, observational Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (known as CENTER-TBI) and NeuroTraumatology Quality Registry (known as Net-QuRe) studies, which enrolled patients throughout Europe and Israel (2014-2020). We included patients with an ASDH who underwent acute neurosurgical evacuation. Patients with severe pre-existing neurological disorders were excluded. In an instrumental variable analysis, we compared outcomes between centres according to treatment preference, measured by the case-mix adjusted proportion DC per centre. The primary outcome was functional outcome rated by the 6-months Glasgow Outcome Scale Extended, estimated with ordinal regression as a common odds ratio (OR), adjusted for prespecified confounders. Variation in centre preference was quantified with the median odds ratio (MOR). CENTER-TBI is registered with ClinicalTrials.gov, number NCT02210221, and the Resource Identification Portal (Research Resource Identifier SCR_015582). - Findings - Between December 19, 2014 and December 17, 2017, 4559 patients with traumatic brain injury were enrolled in CENTER-TBI of whom 336 (7%) underwent acute surgery for ASDH evacuation; 91 (27%) underwent DC and 245 (63%) craniotomy. The proportion primary DC within total acute surgery cases ranged from 6 to 67% with an interquartile range (IQR) of 12-26% among 46 centres; the odds of receiving a DC for prognostically similar patients in one centre versus another randomly selected centre were trebled (adjusted median odds ratio 2.7, p < 0.0001). Higher centre preference for DC over craniotomy was not associated with better functional outcome (adjusted common odds ratio (OR) per 14% [IQR increase] more DC in a centre = 0.9 [95% CI 0.7-1.1], n = 200). Primary DC was associated with more follow-on surgeries and complications [secondary cranial surgery 27% vs. 18%; shunts 11 vs. 5%]; and similar odds of in-hospital mortality (adjusted OR per 14% IQR more primary DC 1.3 [95% CI (1.0-3.4), n = 200]). - Interpretation - We found substantial practice variation in the employment of DC over craniotomy for ASDH. This variation in treatment strategy did not result in different functional outcome. These findings suggest that primary DC should be restricted to salvageable patients in whom immediate replacement of the bone flap is not possible due to intraoperative brain swelling. - Funding - Hersenstichting Nederland for the Dutch NeuroTraumatology Quality Registry and the European Union Seventh Framework Program.
von Mojtaba Oraki Kohshour ; Eva C. Schulte ; Urs Heilbronner ; Monika Budde ; Janos L. Kalman ; Fanny Senner ; Maria Heilbronner ; Daniela Reich-Erkelenz ; Sabrina K. Schaupp ; Thomas Vogl ; Kristina Adorjan ; Ion-George Anghelescu ; Volker Arolt ; Bernhardt T. Baune ; Udo Dannlowski ; Detlef Dietrich ; Andreas Fallgatter ; Christian Figge ; Markus Jäger ; Fabian U. Lang ; Georg Juckel ; Carsten Konrad ; Jens Reimer ; Eva Z. Reininghaus ; Max Schmauß ; Carsten Spitzer ; Martin von Hagen ; Jens Wiltfang ; Jörg Zimmermann ; Till F. M. Andlauer ; Markus Maria Nöthen ; Franziska Degenhardt ; Andreas J. Forstner ; Marcella Rietschel ; Stephanie Witt ; Andre Fischer ; Peter Falkai ; Sergi Papiol ; Thomas G. Schulze
Background - Mitochondria generate energy through oxidative phosphorylation (OXPHOS). The function of key OXPHOS proteins can be altered by variation in mitochondria-related genes, which may increase the risk of mental illness. We investigated the association of mitochondria-related genes and their genetic risk burden with cognitive performance. - Methods - We leveraged cross-sectional data from 1320 individuals with a severe psychiatric disorder and 466 neurotypical individuals from the PsyCourse Study. The cognitive tests analyzed were the Trail-Making Test, Verbal Digit Span Test, Digit-Symbol Test, and Multiple Choice Vocabulary Intelligence Test. Association analyses between the cognitive tests, and single-nucleotide polymorphisms (SNPs) mapped to mitochondria-related genes, and their polygenic risk score (PRS) for schizophrenia (SCZ) were performed with PLINK 1.9 and R program. - Results - We found a significant association (FDR-adjusted p < 0.05) in the Cytochrome C Oxidase Assembly Factor 8 (COA8) gene locus of the OXPHOS pathway with the Verbal Digit Span (forward) test. Mitochondrial PRS was not significantly associated with any of the cognitive tests. - Limitations - Moderate statistical power due to relatively small sample size. - Conclusions - COA8 encodes a poorly characterized mitochondrial protein involved in apoptosis. Here, this gene was associated with the Verbal Digit Span (forward) test, which evaluates short-term memory. Our results warrant replication and may lead to better understanding of cognitive impairment in mental disorders.
Journal of affective disorders Amsterdam [u.a.] : Elsevier Science, 1979 325(2023) vom: Jan., Seite 1-6 Online-Ressource
von Navid Farassat ; Daniel Böhringer ; Sebastian Küchlin ; Fanni E. Molnár ; Anne Schwietering ; Dorina Seger ; Martin J. Hug ; Anja-Birte Knöbel ; Sabine Schneider-Fuchs ; Gabriele Ihorst ; Bettina Kathrin Wabbels ; Christina Beisse ; Focke Ziemssen ; Frank Schüttauf ; Andrea Martina Hedergott ; Theresia Ring-Mangold ; Claudia Schuart ; Armin Wolf ; Stefanie Schmickler ; Julia Biermann ; Philipp Eberwein ; Karsten Hufendiek ; Anja Eckstein ; Gabriele Gusek-Schneider ; Michael Peter Schittkowski ; Thomas Lischka ; Wolf A. Lagrèze
Clinical trials; Medical ophthalmology; OPHTHALMOLOGY; Paediatric ophthalmology
Introduction Myopia is a major cause of degenerative eye disease and increases the risk of secondary visual impairment. Mitigating its progression therefore has great potential of clinically relevant benefit as shown by using highly diluted atropine eye drops in children of Asian origin. However, limited evidence is available regarding the efficacy and safety of low-dose atropine therapy in non-Asian populations. Hence, the Low-dose AtropIne for Myopia Control in Children (AIM) study will test the efficacy and safety of 0.02% atropine vs placebo in a German population. - Methods and analysis AIM is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with two parallel arms. The primary objective is to assess the efficacy of atropine 0.02% eyedrops for myopia control in children of Caucasian origin. The primary outcome is the change in cycloplegic refraction after 1 year of treatment (D/year). Secondary and tertiary outcome measures comprise the change in axial length (mm/year) in children treated with 0.02% atropine compared with placebo, the myopic progression of participants treated with 0.01% compared with 0.02% atropine (D/year and mm/year), and the safety profile of both 0.02% and 0.01% atropine. Furthermore, the myopic progression 1 year after cessation of therapy with 0.02% atropine will be evaluated. Inclusion criteria are an age of 8-12 years and myopia of −1 D to −6 D with an estimated annual myopia progression of ≥0.5 D. After randomisation, patients will receive either atropine 0.02% (arm A) or placebo eye drops (arm B) in the first year of treatment. In the second year, they will continue to receive atropine 0.02% (arm A) or switch to atropine 0.01% (arm B). In the third year, they will switch to placebo (arm A) or continue with atropine 0.01% (arm B). To achieve a statistical power of 80%, the calculated sample size is 300. The trial has started in October 2021 with a planned recruitment period of 18 months. - Ethics and dissemination AIM has been approved by the Central Ethics Committee of the University Medical Center Freiburg (21-1106), local ethics committees of each participating centre and the German Federal Institute for Drugs and Medical Devices (61-3910-4044659). It complies with the Declaration of Helsinki, local laws and ICH-GCP. Results and underlying data from this trial will be disseminated through peer-reviewed publications and conference presentations. - Trial registration number NCT03865160.
BMJ open London : BMJ Publishing Group, 2011 13(2023), 4, Artikel-ID e068822, Seite 1-11 Online-Ressource
von Meike von Wulffen ; Veronika Luehrmann ; Stefanie Robeck ; Antonella Russo ; Lena Fischer-Riepe ; Martijn van den Bosch ; Petrus L. van Lent ; Karin Loser ; Dmitry I. Gabrilovich ; Sven Hermann ; Johannes Roth ; Thomas Vogl
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