23 research outputs found

    Through the looking glass: understanding non-inferiority

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    Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration

    A Diode-Laser-System for Laser-Assisted Bending of Brittle Materials

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    We developed a small and compact system of diode lasers, which can be inserted into the lower tools of a bending press. The parts of the system allow easy plug and play operation and can be installed for any bending length. The diode laser, which is based on 200 W laser bars on microchannel cooler, allows the heating of sheet metals in the forming zone shortly before and during the bending process. There is no unnecessary heating of other parts of the bending equipment, no wear of the tool, and, if properly done, no damage of the surface of the metal. The power per bending length is 16 kW/m

    Follow-up care by a genetic counsellor for relatives at risk for cardiomyopathies is cost-saving and well-appreciated: A randomised comparison

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    Increasing numbers of patient relatives at risk of developing dilated or hypertrophic cardiomyopathy (DCM/HCM) are being identified and followed up by cardiologists according to the ACC/ESC guidelines. However, given limited healthcare resources, good-quality low-cost alternative approaches are needed. Therefore, we have compared conventional follow-up by a cardiologist with that provided at a cardiogenetic clinic (CGC) led by a genetic counsellor. Phenotype-negative first-degree relatives at risk for DCM/HCM were randomly assigned to see either a cardiologist or to attend a CGC. Uptake and resource use were recorded. For 189 participants, we evaluated quality of care experienced, patient satisfaction and perceived personal control (PPC) using validated questionnaires and estimated the average cost difference of these two modes of care. Maximum patient satisfaction scores were achieved more frequently at the CGC (86% vs 45%,
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