临床研究设计应遵循国际规范（附CONSORT规范和STROBE规范中文版）

2013-05-27 MedSci MedSci原创

临床技能与临床研究相辅相成，从临床问题发现，到科研设计，到临床研究，再回归临床，是临床医务工作者职业发展必经之路。临床研究设计是临床研究的第一个环节，将在很大程度上影响临床研究成果的可靠性。一个优秀的临床研究，除了创新性之外，很重要的一点就是临床研究设计的规范性！临床研究的质量控制是研究的核心环节。临床研究涉及面复杂，需要尽最大可能减少或避免偏倚，呈现临床真实信息，所以临床研究的规范性至关重要。目

临床技能与临床研究相辅相成，从临床问题发现，到科研设计，到临床研究，再回归临床，是临床医务工作者职业发展必经之路。

临床研究设计是临床研究的第一个环节，将在很大程度上影响临床研究成果的可靠性。一个优秀的临床研究，除了创新性之外，很重要的一点就是临床研究设计的规范性！临床研究的质量控制是研究的核心环节。临床研究涉及面复杂，需要尽最大可能减少或避免偏倚，呈现临床真实信息，所以临床研究的规范性至关重要。目前国际上的临床研究规范多达23种，常见的有CONSORT规范（适用于随机对照试验），STROBE规范（适用于观察性临床研究），STARD规范（适用于诊断试验）……遵循规范的思想须贯彻于临床研究设计、实施、统计分析以及写作发表整个过程！

下面，小编为大家整理了临床研究常见的RCT研究及观察性临床研究的规范（中文版），另附上关于几则临床研究的实用技巧！

1、RCT临床研究遵循CONSORT规范（中文版）

2、观察性临床研究（病例对照研究）遵循STROBE规范（中文版）

3、临床研究样本量的估计技巧

4、临床试验设计中对照组设置原则

5、安慰剂效应与临床研究设计的关键注意点

您的研究方案靠谱吗？

MedSci特别预告：7/20日前，上传您的临床研究设计方案，即可获得专家免费interview! 更有3万元科研基金资助等你来拿！

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2014-08-19 115

不错，帮了我很大的忙

153 0
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2014-07-12 ccw7878

今天听了Medsci张发宝和马志刚的课程，感觉开朗多了，平时积累的疑问消除了很多，特别是如何避免偏倚

177 0
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2014-06-09 chen111111

非常感谢提供这么好的东西，为什么后面几项没有具体内容呢？

155 0
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2014-06-02 gkbswjd

好东西！感谢编者！

225 0
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2014-05-14 pullo

设计方案时参考

215 0
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2014-03-10 candy007

好啊！帮助太大了

179 0
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2014-03-06 honglian

知道了真的很感谢

130 0
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2014-02-05 lmcqwz

希望能多提供这样的好东东！谢谢

116 0
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2014-01-24 fmy0710

好东西果断下载

125 0
[GetPortalCommentsPageByObjectIdResponse(id=11167, encodeId=af501116ee4, content=不错，帮了我很大的忙, beContent=null, objectType=article, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=210085350, createdName=115, createdTime=Tue Aug 19 11:50:00 CST 2014, time=2014-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10441, encodeId=69f810441ff, content=今天听了Medsci张发宝和马志刚的课程，感觉开朗多了，平时积累的疑问消除了很多，特别是如何避免偏倚, beContent=null, objectType=article, channel=null, level=null, likeNumber=177, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=35e1105587, createdName=ccw7878, createdTime=Sat Jul 12 23:06:00 CST 2014, time=2014-07-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=9736, encodeId=0b9e9e36fa, content=非常感谢提供这么好的东西，为什么后面几项没有具体内容呢？, beContent=null, objectType=article, channel=null, level=null, likeNumber=155, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2d2103784, createdName=chen111111, createdTime=Mon Jun 09 11:03:00 CST 2014, time=2014-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=9657, encodeId=7c44965eb6, content=好东西！感谢编者！, beContent=null, objectType=article, channel=null, level=null, likeNumber=225, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b7fc103377, createdName=gkbswjd, createdTime=Mon Jun 02 18:37:00 CST 2014, time=2014-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=9388, encodeId=5a05938812, content=设计方案时参考 , beContent=null, objectType=article, channel=null, level=null, likeNumber=215, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fa9590666, createdName=pullo, createdTime=Wed May 14 14:20:00 CST 2014, time=2014-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=8258, encodeId=835d8258be, content=好啊！帮助太大了, beContent=null, objectType=article, channel=null, level=null, likeNumber=179, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f1fd91479, createdName=candy007, createdTime=Mon Mar 10 17:15:00 CST 2014, time=2014-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=8161, encodeId=b32781612e, content=知道了真的很感谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=130, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=693f96325, createdName=honglian, createdTime=Thu Mar 06 20:25:00 CST 2014, time=2014-03-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=7209, encodeId=4dd6e20985, content=希望能多提供这样的好东东！谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b45994928, createdName=lmcqwz, createdTime=Wed Feb 05 09:35:00 CST 2014, time=2014-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=7077, encodeId=4272e0771a, content=好东西果断下载, beContent=null, objectType=article, channel=null, level=null, likeNumber=125, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=691941790, createdName=fmy0710, createdTime=Fri Jan 24 16:49:00 CST 2014, time=2014-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=6548, encodeId=2362654852, content=bucuo, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=70b093050, createdName=buddhi, createdTime=Sun Jan 05 17:38:00 CST 2014, time=2014-01-05, status=1, ipAttribution=)]
2014-01-05 buddhi

bucuo

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