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[TCT2012]注册研究与随机临床试验的结合——Stefan James专访
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International Circulation: Could you please give us an introduction to the advantages of the SWEDEHEART registry ?
Dr. Stefan James: The first advantage is that is a national-wide, complete registry with participation of all hospitals. All patients with an MI or undergoing a procedure are entered into the database on a common platform. We have a large number of variables and can also link to other national registries, such as mortality or discharge diagnosis.
《国际循环》:能否请您介绍一下SWEDEHEART注册研究有哪些优势?
Dr. Stefan James: 这项研究的首要优势在于,它是一项全国范围内所有医院均参与其中的全面注册研究。所有心肌梗死(MI)或接受(介入)手术治疗的患者均在一个通用平台上被纳入数据库。我们可获得大量参数指标,并能够与其他国家注册数据相互关联,如死亡率和出院诊断等。
International Circulation: When Dr. Holmes came on, he referred to it as a cheaper registry. Is that a good assessment?
Dr. James: It is cheap, we receive governmental funding that covers costs for the software development and steering committees. By American standards in particular it is very cheap. This is likely because we have less regulation and are less bureaucratic. It has been developed by professionals, not by administrative people. This makes us streamlined and effective.
《国际循环》:Holmes博士评价这是一项非常经济的注册研究。您认为这是一项很好的评估研究吗?
Dr. Stefan James: 这的确是一项非常经济的研究,我们接受的政府资助覆盖了软件开发和指导委员会所需的所有费用。尤其是以美国标准来衡量的话,它非常经济。因为我们避免了过多的干扰和官僚主义作风。这项研究完全由专家负责实施,而不是官方管理人员,这使得我们的执行非常合理、高效。
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