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  • 1
    In: Cardiology, S. Karger AG, Vol. 99, No. 3 ( 2003), p. 153-162
    Abstract: 〈 i 〉 Background: 〈 /i 〉 Magnetic resonance (MR) imaging is frequently used to diagnose arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D). However, the reliability of various MR imaging features for diagnosing ARVC/D is unknown. The purpose of this study was to determine which morphologic MR imaging features have the greatest interobserver reliability for diagnosing ARVC/D. 〈 i 〉 Methods: 〈 /i 〉 Forty-five sets of films of cardiac MR images were sent to 8 radiologists and 5 cardiologists with experience in this field. There were 7 cases of definite ARVC/D as defined by the Task Force criteria. Six cases were controls. The remaining 32 cases had MR imaging because of clinical suspicion of ARVC/D. Readers evaluated the images for the presence of (a) right ventricle (RV) enlargement, (b) RV abnormal morphology, (c) left ventricle enlargement, (d) presence of high T 〈 sub 〉 1 〈 /sub 〉 signal (fat) in the myocardium, and (e) location of high T 〈 sub 〉 1 〈 /sub 〉 signal (fat) on a Likert scale with formatted responses. 〈 i 〉 Results: 〈 /i 〉 Readers indicated that the Task Force ARVC/D cases had significantly more (χ 〈 sup 〉 2 〈 /sup 〉 = 119.93, d.f. = 10, p 〈 0.0001) RV chamber size enlargement (58%) than either the suspected ARVC/D (12%) or no ARVC/D (14%) cases. When readers reported the RV chamber size as enlarged they were significantly more likely to report the case as ARVC/D present (χ 〈 sup 〉 2 〈 /sup 〉 〈 sup 〉 = 〈 /sup 〉 33.98, d.f. = 1, p 〈 0.0001). When readers reported the morphology as abnormal they were more likely to diagnose the case as ARVC/D present (χ 〈 sup 〉 2 〈 /sup 〉 = 78.4, d.f. = 1, p 〈 0.0001), and the Task Force ARVC/D (47%) cases received significantly more abnormal reports than either suspected ARVC/D (20%) or non-ARVC/D (15%) cases. There was no significant difference between patient groups in the reported presence of high signal intensity (fat) in the RV (χ 〈 sup 〉 2 〈 /sup 〉 = 0.9, d.f. = 2, p 〉 0.05). 〈 i 〉 Conclusions: 〈 /i 〉 Reviewers found that the size and shape of abnormalities in the RV are key MR imaging discriminates of ARVD. Subsequent protocol development and multicenter trials need to address these parameters. Essential steps in improving accuracy and reducing variability include a standardized acquisition protocol and standardized analysis with dynamic cine review of regional RV function and quantification of RV and left ventricle volumes.
    Type of Medium: Online Resource
    ISSN: 0008-6312 , 1421-9751
    RVK:
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2003
    detail.hit.zdb_id: 1482041-9
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  • 2
    In: European Neurology, S. Karger AG, Vol. 60, No. 3 ( 2008), p. 122-126
    Abstract: 〈 i 〉 Background/Aims: 〈 /i 〉 In 1998, the European Medicines Agency suspended the approval for tolcapone in Parkinson’s disease (PD) with motor complications due to the drug’s implication in fulminant liver failure and the consequent death of 3 patients. Clinical data obtained by ongoing use of tolcapone in other countries proved that adequate safety can be achieved if liver enzymes are strictly monitored. In 2005, tolcapone was relaunched in the European Union under the prerequisite of biweekly liver enzyme monitoring. The objective of this study was to evaluate the compliance with mandatory drug safety monitoring under real-life conditions. 〈 i 〉 Methods: 〈 /i 〉 Twenty-one Parkinson’s disease patients receiving tolcapone were analyzed with regard to their compliance in performing and reporting the required laboratory tests. 〈 i 〉 Results: 〈 /i 〉 Tolcapone was effective and well tolerated. Yet, less than 25% of the patients regularly performed and reported the required laboratory tests and the compliance declined when comparing the first and second half-years of therapy. 〈 i 〉 Conclusions: 〈 /i 〉 Our data shed light on the incongruity between requirements of postmarketing drug surveillance and every-day reality. The depicted noncompliance is most likely a general problem in postmarketing drug surveillance with an impact for physicians, manufacturers and legal authorities. Practical, legal and ethical aspects will be discussed.
    Type of Medium: Online Resource
    ISSN: 0014-3022 , 1421-9913
    RVK:
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2008
    detail.hit.zdb_id: 1482237-4
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