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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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 编辑:国际循环网 时间:2012/11/1 14:30:10    加入收藏
 关键字:心肌梗死 介入手术治疗 软件开发 

  International Circulation: This added feature of randomizing patients in the registry or patients that are going into the registry, what are some of the draw backs that you predict?
  Dr. James: In our case, this registry is nationwide and all hospitals participate, but we need to convince physicians to participate. This is an interesting hypothesis and need to spend some time on this trial. We physicians to fill out extra variables and spend extra time on that specific trial. We need them to agree on. Since Sweden is a small country, we need complete participation. Sweden is a country of 9 million people. If you want to enroll 7,000 patients within two years, we need all the patients. Otherwise it cannot be done
  International Circulation: Do you think smaller countries have an advantage in making efficient and inexpensive registries?
  Dr. James: Sweden has done the largest STEMI trial ever with a medical device. This is larger than the Horizon AMI trial for example. That is pretty amazing.
  《国际循环》:鉴于这种向注册数据库中额外加入随机化患者或将患者纳入注册研究中的特点,您预计会产生怎样的不足?
  Dr. Stefan James: 就我们这项研究而言,全国范围内所有医院均参与其中,但我们必须确信医生的参与。这是一个有趣的推断,需要花费一些时间。我们的医生录入额外的参数,并额外付出时间进行这项特殊的试验,所以需要征得他们的同意。因为瑞典是一个较小的国家,仅有九百万人口,我们需要全员参与。如果需要在2年中纳入7000例患者,我们就需要所有的患者,否则无法实施。做为只有九百万人口的国家,瑞典开展了最大规模的STEMI的支架试验,规模比Horizon-AMI还要大,这是令人惊异的。



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