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  • 2019Journal Article
    [["dc.bibliographiccitation.firstpage","591"],["dc.bibliographiccitation.issue","5"],["dc.bibliographiccitation.journal","Statistics in Medicine"],["dc.bibliographiccitation.lastpage","601"],["dc.bibliographiccitation.volume","39"],["dc.contributor.author","Zapf, Antonia"],["dc.contributor.author","Stark, Maria"],["dc.contributor.author","Gerke, Oke"],["dc.contributor.author","Ehret, Christoph"],["dc.contributor.author","Benda, Norbert"],["dc.contributor.author","Bossuyt, Patrick"],["dc.contributor.author","Deeks, Jon"],["dc.contributor.author","Reitsma, Johannes"],["dc.contributor.author","Alonzo, Todd"],["dc.contributor.author","Friede, Tim"],["dc.date.accessioned","2019-12-16T11:36:23Z"],["dc.date.accessioned","2021-10-27T13:21:56Z"],["dc.date.available","2019-12-16T11:36:23Z"],["dc.date.available","2021-10-27T13:21:56Z"],["dc.date.issued","2019"],["dc.description.abstract","The aim of diagnostic accuracy studies is to evaluate how accurately a diagnostic test can distinguish diseased from nondiseased individuals. Depending on the research question, different study designs and accuracy measures are appropriate. As the prior knowledge in the planning phase is often very limited, modifications of design aspects such as the sample size during the ongoing trial could increase the efficiency of diagnostic trials. In intervention studies, group sequential and adaptive designs are well established. Such designs are characterized by preplanned interim analyses, giving the opportunity to stop early for efficacy or futility or to modify elements of the study design. In contrast, in diagnostic accuracy studies, such flexible designs are less common, even if they are as important as for intervention studies. However, diagnostic accuracy studies have specific features, which may require adaptations of the statistical methods or may lead to specific advantages or limitations of sequential and adaptive designs. In this article, we summarize the current status of methodological research and applications of flexible designs in diagnostic accuracy research. Furthermore, we indicate and advocate future development of adaptive design methodology and their use in diagnostic accuracy trials from an interdisciplinary viewpoint. The term \"interdisciplinary viewpoint\" describes the collaboration of experts of the academic and nonacademic research."],["dc.identifier.doi","10.1002/sim.8430"],["dc.identifier.eissn","1097-0258"],["dc.identifier.isbn","31773788"],["dc.identifier.issn","0277-6715"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/16944"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/92056"],["dc.language.iso","en"],["dc.notes.intern","Migrated from goescholar"],["dc.relation.eissn","1097-0258"],["dc.relation.issn","1097-0258"],["dc.relation.issn","0277-6715"],["dc.relation.orgunit","Universitätsmedizin Göttingen"],["dc.rights","CC BY-NC-ND 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by-nc-nd/4.0"],["dc.subject.ddc","610"],["dc.title","Adaptive trial designs in diagnostic accuracy research"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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  • 2018Journal Article
    [["dc.bibliographiccitation.firstpage","1"],["dc.bibliographiccitation.journal","Movement Disorders Clinical Practice"],["dc.bibliographiccitation.lastpage","4"],["dc.bibliographiccitation.volume","Early View Status"],["dc.contributor.author","Halsband, Claire"],["dc.contributor.author","Zapf, Antonia"],["dc.contributor.author","Sixel-Döring, Friederike"],["dc.contributor.author","Trenkwalder, Claudia"],["dc.contributor.author","Mollenhauer, Brit"],["dc.date.accessioned","2019-07-09T11:45:02Z"],["dc.date.available","2019-07-09T11:45:02Z"],["dc.date.issued","2018"],["dc.description.abstract","Background: Rapid eye movement (REM) sleep behavior disorder (RBD) is one of the most specific prodromal indicators for Parkinson's disease (PD). Objectives: To test the validity of the RBD-Screening Questionnaire (RBDSQ) in assessing RBD in early PD. Methods: The RBDSQ was completed before video-supported polysomnography (vPSG) by 134 de novo PD patients, 109 matched controls without neurological disorder (CTR) and 30 subjects with idiopathic RBD (iRBD) without clinical signs of PD; results were compared with vPSG-confirmed RBD diagnosis. Results and Conclusions: Sensitivity/specificity of the RBDSQ for the PD cohort were 0.44/0.84 at the previously published cut-off score of 6 for PD patients, and the area under the curve (AUC) 0.68 (95% CI, 0.56–0.79). By contrast, in the iRBD/CTR cohort the RBDSQ (cut-off = 5) had a sensitivity/specificity of 0.97/0.84 and an AUC of 0.95 (95% CI, 0.90–1.00). Subanalysis of question 6 only (4 subitems asking for dream enactment) at a cut-off score of 1 revealed a sensitivity of 0.74 and a specificity of 0.70 for the de novo PD cohort, AUC was 0.74 (95% CI, 0.63–0.84). RBDSQ is an insufficient screening tool for RBD in de novo PD. New screening tools for RBD assessment need to be developed."],["dc.identifier.doi","10.1002/mdc3.12591"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/15012"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/59145"],["dc.language.iso","en"],["dc.notes.intern","Merged from goescholar"],["dc.relation","info:eu-repo/grantAgreement/EC/H2020/634821/EU//PROPAG-AGEING"],["dc.relation.issn","2330-1619"],["dc.rights","CC BY 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/4.0"],["dc.subject.ddc","610"],["dc.title","The REM Sleep Behavior Disorder Screening Questionnaire is not Valid in De Novo Parkinson's Disease"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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  • 2019Journal Article
    [["dc.bibliographiccitation.artnumber","1"],["dc.bibliographiccitation.firstpage","10"],["dc.bibliographiccitation.journal","European Radiology"],["dc.contributor.author","Uhlig, Johannes"],["dc.contributor.author","Lücke, Christian"],["dc.contributor.author","Vliegenthart, Rozemarijn"],["dc.contributor.author","Loewe, Christian"],["dc.contributor.author","Grothoff, Matthias"],["dc.contributor.author","Schuster, Andreas"],["dc.contributor.author","Lurz, Philipp"],["dc.contributor.author","Jacquier, Alexis"],["dc.contributor.author","Francone, Marco"],["dc.contributor.author","Zapf, Antonia"],["dc.contributor.author","Schülke, Christoph"],["dc.contributor.author","May, Matthias Stefan"],["dc.contributor.author","Bremerich, Jens"],["dc.contributor.author","Lotz, Joachim"],["dc.contributor.author","Gutberlet, Matthias"],["dc.date.accessioned","2019-07-09T11:51:32Z"],["dc.date.available","2019-07-09T11:51:32Z"],["dc.date.issued","2019"],["dc.description.abstract","OBJECTIVES: To assess the incidence of acute adverse events (AAEs) in gadolinium-enhanced cardiac magnetic resonance (CMR) imaging. METHODS: Gadolinium-based contrast agent (GBCA)-enhanced CMR data from the multinational, multicenter European Society of Cardiovascular Radiology MRCT Registry was included. AAE severity was classified according to the American College of Radiology Manual on Contrast Media (mild, moderate, severe). Multivariable generalized linear mixed effect models were used to assess the likelihood of AAEs in various GBCA, adjusting for pharmacological stressor, main indications (i.e., suspected or known coronary artery disease or myocarditis), age, sex, and submitting center as a random effect. RESULTS: In the study population of 72,839 GBCA-enhanced CMRs, a total of 260 AAEs were reported (0.36%), with a minority of severe AAEs (n = 24, 0.033%). Allergic-like AAEs were less likely than physiologic AAEs (29% versus 71%). Patients without pharmacological stress imaging had a lower AAE rate (0.22%) compared to stress imaging (0.75%), with the highest AAE rates for regadenoson (2.95%). AAE rates also varied by GBCA subtype (overall p < 0.001). There was significant interaction between GBCA and pharmacological stressor (interaction p = 0.025), with AAE rates ranging between 0 and 10% for certain GBCA/stressor combinations. There was further marginal evidence that higher GBCA volume was associated with higher AAE incidence (OR = 1.02, p = 0.05). CONCLUSION: GBCA-enhanced CMR imaging demonstrates low AAE rates comparable to those of other body regions. AAE likelihood correlates with GBCA subtype, pharmacological stressor, and imaging indication. Intravenous fluid administration in patients with cardiac impairment might contribute to these findings. KEY POINTS: • Acute adverse event rates in cardiac magnetic resonance (CMR) imaging with gadolinium-based contrast agents (GBCAs) are low (0.36%), especially for severe adverse events (0.033%). • Mild and moderate adverse events are more frequent during stress CMR imaging. • Physiologic AAEs are more common than allergic AAEs in CMR imaging."],["dc.identifier.doi","10.1007/s00330-019-06171-2"],["dc.identifier.pmid","31041566"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/16147"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/59966"],["dc.language.iso","en"],["dc.notes.intern","Merged from goescholar"],["dc.relation.issn","1432-1084"],["dc.rights","CC BY 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/4.0"],["dc.subject.ddc","610"],["dc.title","Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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