Harden, Markus

[["dc.bibliographiccitation.firstpage","3869"],["dc.bibliographiccitation.issue","12"],["dc.bibliographiccitation.journal","Knee Surgery, Sports Traumatology, Arthroscopy"],["dc.bibliographiccitation.lastpage","3877"],["dc.bibliographiccitation.volume","25"],["dc.contributor.author","Balcarek, Peter"],["dc.contributor.author","Rehn, Stephan"],["dc.contributor.author","Howells, Nick R."],["dc.contributor.author","Eldridge, Jonathan D."],["dc.contributor.author","Kita, Keisuke"],["dc.contributor.author","Dejour, David"],["dc.contributor.author","Nelitz, Manfred"],["dc.contributor.author","Banke, Ingo J."],["dc.contributor.author","Lambrecht, Delphine"],["dc.contributor.author","Harden, Markus"],["dc.contributor.author","Friede, Tim"],["dc.date.accessioned","2020-12-10T14:09:50Z"],["dc.date.available","2020-12-10T14:09:50Z"],["dc.date.issued","2016"],["dc.identifier.doi","10.1007/s00167-016-4365-x"],["dc.identifier.eissn","1433-7347"],["dc.identifier.issn","0942-2056"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/70574"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.title","Results of medial patellofemoral ligament reconstruction compared with trochleoplasty plus individual extensor apparatus balancing in patellar instability caused by severe trochlear dysplasia: a systematic review and meta-analysis"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","3437"],["dc.bibliographiccitation.issue","36"],["dc.bibliographiccitation.journal","European Heart Journal"],["dc.bibliographiccitation.lastpage","3447"],["dc.bibliographiccitation.volume","41"],["dc.contributor.author","Zabel, Markus"],["dc.contributor.author","Willems, Rik"],["dc.contributor.author","Lubinski, Andrzej"],["dc.contributor.author","Bauer, Axel"],["dc.contributor.author","Brugada, Josep"],["dc.contributor.author","Conen, David"],["dc.contributor.author","Flevari, Panagiota"],["dc.contributor.author","Hasenfuß, Gerd"],["dc.contributor.author","Harden, Markus"],["dc.contributor.author","Friede, Tim"],["dc.contributor.author","Zabel, Markus"],["dc.contributor.author","Lüthje, Lars"],["dc.contributor.author","Haarmann, Helge"],["dc.contributor.author","Bergau, Leonard"],["dc.contributor.author","Tichelbäcker, Tobias"],["dc.contributor.author","Hasenfuß, Gerd"],["dc.contributor.author","Friede, Tim"],["dc.contributor.author","Zabel, Markus"],["dc.contributor.author","Friede, Tim"],["dc.contributor.author","Harden, Markus"],["dc.contributor.author","Pieske, Burkert"],["dc.contributor.authorgroup","EU-CERT-ICD Study Investigators"],["dc.date.accessioned","2020-05-07T07:50:46Z"],["dc.date.accessioned","2021-10-27T13:22:10Z"],["dc.date.available","2020-05-07T07:50:46Z"],["dc.date.available","2021-10-27T13:22:10Z"],["dc.date.issued","2020"],["dc.description.abstract","Aims: The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated, controlled cohort study, was conducted in 44 centres and 15 European countries. It aimed to assess current clinical effectiveness of primary prevention ICD therapy. Methods and results: We recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and follow-up (FU) data from 2247 patients were analysable, 1516 patients before first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537–0.865, P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection fraction (LVEF), New York Heart Association class

[["dc.bibliographiccitation.artnumber","156"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","BMC Medical Research Methodology"],["dc.bibliographiccitation.volume","18"],["dc.contributor.author","Harden, Markus"],["dc.contributor.author","Friede, Tim"],["dc.date.accessioned","2019-07-09T11:49:34Z"],["dc.date.available","2019-07-09T11:49:34Z"],["dc.date.issued","2018"],["dc.description.abstract","Abstract Background Multi-centre randomized controlled clinical trials play an important role in modern evidence-based medicine. Advantages of collecting data from more than one site are numerous, including accelerated recruitment and increased generalisability of results. Mixed models can be applied to account for potential clustering in the data, in particular when many small centres contribute patients to the study. Previously proposed methods on sample size calculation for mixed models only considered balanced treatment allocations which is an unlikely outcome in practice if block randomisation with reasonable choices of block length is used. Methods We propose a sample size determination procedure for multi-centre trials comparing two treatment groups for a continuous outcome, modelling centre differences using random effects and allowing for arbitrary sample sizes. It is assumed that block randomisation with fixed block length is used at each study site for subject allocation. Simulations are used to assess operation characteristics such as power of the sample size approach. The proposed method is illustrated by an example in disease management systems. Results A sample size formula as well as a lower and upper boundary for the required overall sample size are given. We demonstrate the superiority of the new sample size formula over the conventional approach of ignoring the multi-centre structure and show the influence of parameters such as block length or centre heterogeneity. The application of the procedure on the example data shows that large blocks require larger sample sizes, if centre heterogeneity is present. Conclusion Unbalanced treatment allocation can result in substantial power loss when centre heterogeneity is present but not considered at the planning stage. When only few patients by centre will be recruited, one has to weigh the risk of imbalance between treatment groups due to large blocks and the risk of unblinding due to small blocks. The proposed approach should be considered when planning multi-centre trials."],["dc.identifier.doi","10.1186/s12874-018-0602-y"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/15714"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/59583"],["dc.language.iso","en"],["dc.notes.intern","Merged from goescholar"],["dc.publisher","BioMed Central"],["dc.rights","CC BY 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/4.0"],["dc.title","Sample size calculation in multi-centre clinical trials"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","1284"],["dc.bibliographiccitation.issue","5"],["dc.bibliographiccitation.journal","Biometrical Journal"],["dc.bibliographiccitation.lastpage","1299"],["dc.bibliographiccitation.volume","62"],["dc.contributor.author","Harden, Markus"],["dc.contributor.author","Friede, Tim"],["dc.date.accessioned","2021-04-14T08:27:16Z"],["dc.date.available","2021-04-14T08:27:16Z"],["dc.date.issued","2020"],["dc.description.abstract","Abstract Many late‐phase clinical trials recruit subjects at multiple study sites. This introduces a hierarchical structure into the data that can result in a power‐loss compared to a more homogeneous single‐center trial. Building on a recently proposed approach to sample size determination, we suggest a sample size recalculation procedure for multicenter trials with continuous endpoints. The procedure estimates nuisance parameters at interim from noncomparative data and recalculates the sample size required based on these estimates. In contrast to other sample size calculation methods for multicenter trials, our approach assumes a mixed effects model and does not rely on balanced data within centers. It is therefore advantageous, especially for sample size recalculation at interim. We illustrate the proposed methodology by a study evaluating a diabetes management system. Monte Carlo simulations are carried out to evaluate operation characteristics of the sample size recalculation procedure using comparative as well as noncomparative data, assessing their dependence on parameters such as between‐center heterogeneity, residual variance of observations, treatment effect size and number of centers. We compare two different estimators for between‐center heterogeneity, an unadjusted and a bias‐adjusted estimator, both based on quadratic forms. The type 1 error probability as well as statistical power are close to their nominal levels for all parameter combinations considered in our simulation study for the proposed unadjusted estimator, whereas the adjusted estimator exhibits some type 1 error rate inflation. Overall, the sample size recalculation procedure can be recommended to mitigate risks arising from misspecified nuisance parameters at the planning stage."],["dc.identifier.doi","10.1002/bimj.201900138"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/82225"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-399"],["dc.relation.eissn","1521-4036"],["dc.relation.issn","0323-3847"],["dc.rights","This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited."],["dc.title","Sample size recalculation in multicenter randomized controlled clinical trials based on noncomparative data"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","2160"],["dc.bibliographiccitation.issue","10"],["dc.bibliographiccitation.journal","Pain"],["dc.bibliographiccitation.lastpage","2172"],["dc.bibliographiccitation.volume","157"],["dc.contributor.author","Straube, Sebastian"],["dc.contributor.author","Harden, Markus"],["dc.contributor.author","Schroeder, Heiko"],["dc.contributor.author","Arendacka, Barbora"],["dc.contributor.author","Fan, Xiangning"],["dc.contributor.author","Moore, R. Andrew"],["dc.contributor.author","Friede, Tim"],["dc.date.accessioned","2018-11-07T10:07:45Z"],["dc.date.available","2018-11-07T10:07:45Z"],["dc.date.issued","2016"],["dc.description.abstract","Back schools are interventions that comprise exercise and education components. We aimed to systematically review the randomized controlled trial evidence on back schools for the treatment of chronic low back pain. By searching MEDLINE, Embase, and Cochrane Central as well as bibliographies, we identified 31 studies for inclusion in our systematic review and 5 of these for inclusion in meta-analyses. Meta-analyses for pain scores and functional outcomes revealed statistical superiority of back schools vs no intervention for some comparisons but not others. No meta-analysis was feasible for the comparison of back schools vs other active treatments. Adverse events were poorly reported so that no reliable conclusions regarding the safety of back schools can be drawn, although some limited reassurance in this regard may be derived from the fact that few adverse events and no serious adverse events were reported in the back school groups in the studies that did report on safety. Overall, the evidence base for the use of back schools to treat chronic low back pain is weak; in nearly a half-century since back schools were first trialled, no unequivocal evidence of benefit has emerged."],["dc.description.sponsorship","Federal Ministry of Education and Research, Germany [01KG1409]"],["dc.identifier.doi","10.1097/j.pain.0000000000000640"],["dc.identifier.isi","000386015500006"],["dc.identifier.pmid","27257858"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/39339"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","Lippincott Williams & Wilkins"],["dc.relation.issn","1872-6623"],["dc.relation.issn","0304-3959"],["dc.title","Back schools for the treatment of chronic low back pain: possibility of benefit but no convincing evidence after 47 years of research-systematic review and meta-analysis"],["dc.type","review"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","S34"],["dc.bibliographiccitation.journal","Journal of Electrocardiology"],["dc.bibliographiccitation.lastpage","S39"],["dc.bibliographiccitation.volume","57"],["dc.contributor.author","Zabel, Markus"],["dc.contributor.author","Schlögl, Simon"],["dc.contributor.author","Lubinski, Andrzej"],["dc.contributor.author","Svendsen, Jesper Hastrup"],["dc.contributor.author","Bauer, Axel"],["dc.contributor.author","Arbelo, Elena"],["dc.contributor.author","Brusich, Sandro"],["dc.contributor.author","Conen, David"],["dc.contributor.author","Cygankiewicz, Iwona"],["dc.contributor.author","Dommasch, Michael"],["dc.contributor.author","Flevari, Panagiota"],["dc.contributor.author","Galuszka, Jan"],["dc.contributor.author","Hansen, Jim"],["dc.contributor.author","Hasenfuß, Gerd"],["dc.contributor.author","Hatala, Robert"],["dc.contributor.author","Huikuri, Heikki V."],["dc.contributor.author","Kenttä, Tuomas"],["dc.contributor.author","Kucejko, Tomasz"],["dc.contributor.author","Haarmann, Helge"],["dc.contributor.author","Harden, Markus"],["dc.contributor.author","Iovev, Svetoslav"],["dc.contributor.author","Kääb, Stefan"],["dc.contributor.author","Kaliska, Gabriela"],["dc.contributor.author","Katsimardos, Andreas"],["dc.contributor.author","Kasprzak, Jaroslaw D."],["dc.contributor.author","Qavoq, Dariusz"],["dc.contributor.author","Lüthje, Lars"],["dc.contributor.author","Malik, Marek"],["dc.contributor.author","Novotný, Tomáš"],["dc.contributor.author","Pavlović, Nikola"],["dc.contributor.author","Perge, Peter"],["dc.contributor.author","Röver, Christian"],["dc.contributor.author","Schmidt, Georg"],["dc.contributor.author","Shalganov, Tchavdar"],["dc.contributor.author","Sritharan, Rajeeva"],["dc.contributor.author","Svetlosak, Martin"],["dc.contributor.author","Sallo, Zoltan"],["dc.contributor.author","Szavits-Nossan, Janko"],["dc.contributor.author","Traykov, Vassil"],["dc.contributor.author","Vandenberk, Bert"],["dc.contributor.author","Velchev, Vasil"],["dc.contributor.author","Vos, Marc A."],["dc.contributor.author","Willich, Stefan N."],["dc.contributor.author","Friede, Tim"],["dc.contributor.author","Willems, Rik"],["dc.contributor.author","Merkely, Béla"],["dc.contributor.author","Sticherling, Christian"],["dc.date.accessioned","2020-12-10T14:25:06Z"],["dc.date.available","2020-12-10T14:25:06Z"],["dc.date.issued","2019"],["dc.identifier.doi","10.1016/j.jelectrocard.2019.09.001"],["dc.identifier.issn","0022-0736"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/16386"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/72436"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.notes.intern","Merged from goescholar"],["dc.rights","Goescholar"],["dc.rights.uri","https://goescholar.uni-goettingen.de/licenses"],["dc.title","Present criteria for prophylactic ICD implantation: Insights from the EU-CERT-ICD (Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in EUrope) project"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","submitted_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","196"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","Diabetes Care"],["dc.bibliographiccitation.lastpage","200"],["dc.bibliographiccitation.volume","43"],["dc.contributor.author","Junttila, M. Juhani"],["dc.contributor.author","Pelli, Ari"],["dc.contributor.author","Kenttä, Tuomas V."],["dc.contributor.author","Friede, Tim"],["dc.contributor.author","Willems, Rik"],["dc.contributor.author","Bergau, Leonard"],["dc.contributor.author","Malik, Marek"],["dc.contributor.author","Vandenberk, Bert"],["dc.contributor.author","Vos, Marc A."],["dc.contributor.author","Schmidt, Georg"],["dc.contributor.author","Merkely, Bela"],["dc.contributor.author","Lubinski, Andrzej"],["dc.contributor.author","Svetlosak, Martin"],["dc.contributor.author","Braunschweig, Frieder"],["dc.contributor.author","Harden, Markus"],["dc.contributor.author","Zabel, Markus"],["dc.contributor.author","Huikuri, Heikki V."],["dc.contributor.author","Sticherling, Christian"],["dc.date.accessioned","2020-12-10T18:43:45Z"],["dc.date.available","2020-12-10T18:43:45Z"],["dc.date.issued","2019"],["dc.identifier.doi","10.2337/dc19-1014"],["dc.identifier.eissn","1935-5548"],["dc.identifier.issn","0149-5992"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/78224"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.title","Appropriate Shocks and Mortality in Patients With Versus Without Diabetes With Prophylactic Implantable Cardioverter Defibrillators"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]