Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2009
[Clinical trials in children--between the expectations of scientific requirements, the assurance of proven treatment and ethical demands].
Regulation (EC) No. 1901/2006 of the European Parliament and the Council dated 12 December 2008 on medicinal products for paediatric use is the result of a survey by the European Commission, concluding that children in the European Union are inadequately treated with medicinal products. The Regulation is addressed to the pharmaceutical industry with the intention to place medicinal products on the market and to the Member States to register all information on medicinal products for the treatment of children. ⋯ This will be supported by incentives and rewards. As a consequence of the requirement to conduct clinical trials in children the framework and conditions have to be defined and ethical considerations have to be respected.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2009
[Clinical trials: methodological requirements and interpretation].
Clinical trials are performed to answer a large variety of questions. Of special relevance is their use in testing and estimating the benefit of medical interventions. ⋯ Methods have been developed and improved during recent decades. This article describes essentials of modern clinical trial methodology.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Mar 2009
Review[Intelligent telemedicine in intensive care units. Bed-side operation of medical technology devices and IT in intensive care medicine].
Patient data management systems (PDMS) may improve the quality of clinical documentation in intensive care medicine. In addition to the documentation, many PDMS offer the clinicians support for clinical decisions and workflow. The data recorded by the PDMS are available for data analysis to support administrative responsibilities (e.g., reimbursement, personnel management, quality management) or scientific questions. ⋯ This is partly caused by the fact that the effort necessary to implement a standard vocabulary is not equally shared between the sending and receiving systems. The solution could be medical devices that send LOINC-coded data. The experience of implementing LOINC into medical devices and information systems teaches us that more research and development of new functionalities for clinical information systems and PDMS to display and process (LOINC) coded data are needed.