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讲堂：临床试验报告的统一标准（CONSORT）

2018-12-13 佚名 复旦循证护理中心

临床试验报告
关注

一随机对照试验及其报告现状随机对照试验（RCT）通常是评估干预效果的最佳研究设计，但低质量的临床试验可能会错误地估计疗效。自2000年以来，每年都有25000篇随机或对照试验的文章被发表，但庞大的数量并不意味着决策者很容易找到可信的证据进行临床和保健决策，中国发表的随机对照试验文章质量亦令人堪忧。解决这些问题，一方面需从源头抓起，注重顶层设计和实施过程的质量控制；另一方面，完整、准确地报告研究论文

一

随机对照试验及其报告现状

随机对照试验（RCT）通常是评估干预效果的最佳研究设计，但低质量的临床试验可能会错误地估计疗效。自2000年以来，每年都有25000篇随机或对照试验的文章被发表，但庞大的数量并不意味着决策者很容易找到可信的证据进行临床和保健决策，中国发表的随机对照试验文章质量亦令人堪忧。解决这些问题，一方面需从源头抓起，注重顶层设计和实施过程的质量控制；另一方面，完整、准确地报告研究论文也有助于读者判断临床试验的内外部真实性（或称有效性）和应用价值。

本次讲堂旨在对近年来国际上提出的随机对照试验相关报告规范即临床试验报告的统一标准（Consolidated standards of reporting trials，CONSORT）及其扩展版进行简介。1995年，为了提高随机对照试验报告质量，一个由临床试验学者、统计学家、流行病学家和生物医学编辑组成的国际小组制定了CONSORT。1999年，CONSORT制定组织对CONSORT进行了修订，成为一个由22个条目组成的清单，见表1。

二 CONSORT清单


三参考文献

詹思延.第二讲：如何报告随机对照试验——国际报告规范CONSORT及其扩展版解读[J].中国循证儿科杂志，2010，5(02)：146-150.

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    2019-09-07 146f1ad4m53暂无昵称

    马住了

    0

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    2019-11-03 zlawrance

    #统一标准#

    0

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    2018-12-15 tomyang91

    #CONSORT#

    0

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    2018-12-15 tomyang91

    #CONSORT#

    0

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    2018-12-14 orangesking

    好

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=372397, encodeId=89f33e2397c2, content=马住了, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1b8b5179002, createdName=146f1ad4m53暂无昵称, createdTime=Sat Sep 07 10:53:27 CST 2019, time=2019-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2045526, encodeId=15ab204552617, content=<a href='/topic/show?id=e1bbe8920fa' target=_blank style='color:#2F92EE;'>#统一标准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78920, encryptionId=e1bbe8920fa, topicName=统一标准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f5e185, createdName=zlawrance, createdTime=Sun Nov 03 23:40:00 CST 2019, time=2019-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558469, encodeId=53841558469ca, content=<a href='/topic/show?id=a988506424' target=_blank style='color:#2F92EE;'>#CONSORT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5064, encryptionId=a988506424, topicName=CONSORT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c55a14990568, createdName=tomyang91, createdTime=Sat Dec 15 13:40:00 CST 2018, time=2018-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564478, encodeId=fcff15644e8de, content=<a href='/topic/show?id=a988506424' target=_blank style='color:#2F92EE;'>#CONSORT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5064, encryptionId=a988506424, topicName=CONSORT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c55a14990568, createdName=tomyang91, createdTime=Sat Dec 15 13:40:00 CST 2018, time=2018-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=355438, encodeId=e01b35543848, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Fri Dec 14 23:52:26 CST 2018, time=2018-12-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=355360, encodeId=0796355360cc, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRkia1DP5MpwEgtXo1XhXA11xD6MWKxunAZFXKSNic0fWHUQx83oNHPlRMxxIctM83QKeCLkJpMibibiaC/0, createdBy=7e581734408, createdName=深海的鱼, createdTime=Fri Dec 14 06:45:47 CST 2018, time=2018-12-14, status=1, ipAttribution=)]
    2018-12-14 深海的鱼

    学习学习学习

    0

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