多中心临床试验中中心校正的统计学实现(SPSS)

2013-11-19 MedSci MedSci原创

多中心临床试验可以在较短的时间内招募到足够多的病例数,同时,来自多中心的病例比来自单中心的病例更具有代表性,可以使所得结论的应用面更广泛。但由于各中心的试验条件不完全相同,所得结论也不尽相同。因此, 在评价疗效时, 必须考虑中心间效应的差别。当中心间差距较大时,如果直接合并各中心资料,可能会对总的结论有一定影响。这里涉及到两个问题,其一是评价中心效应是否存在,其二是如何扣除中心效应的影响对疗效进行

多中心临床试验可以在较短的时间内招募到足够多的病例数,同时,来自多中心的病例比来自单中心的病例更具有代表性,可以使所得结论的应用面更广泛。但由于各中心的试验条件不完全相同,所得结论也不尽相同。因此,在评价疗效时, 必须考虑中心间效应的差别。当中心间差距较大时,如果直接合并各中心资料,可能会对总的结论有一定影响。 这里涉及到两个问题,其一是评价中心效应是否存在,其二是如何扣除中心效应的影响对疗效进行比较。目前,评价有效率的中心间差别,常用Breslow-Day 检验;而消除中心间的差异对疗效的影响,常采用CMH (Corchran-Mental-Haenszel) 方法 。本文简单介绍有效率的中心间差别的Breslow-Day 检验,以及扣除中心效应的CMH 方法;并进一步讨论logistic 回归模型在对中心效应进行评价和修正中的应用。 一、 用CMH方法进行统计分析 SPSS中只能进行多中心2x2格式的CMH检验(即组别为2个,疗效指标为2分类变量)。分析时,可通过描述性分析-列联表分析。将中心变量选入分层变量栏中,并在Statistic栏中选中卡方分析和Cochrans &nb

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  1. [GetPortalCommentsPageByObjectIdResponse(id=10675, encodeId=13cb106e5db, content=题目很吸引人,内容完全是...额.....跟没说一样,方法大家都知道,你倒是举个栗子分析一下啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83erCH0VlRzV7nkwya6pUA59besr9ChGrgDiaqibGf7VkCb1x28oPsXicicqCXC7wLGHbQ8zEfUyWgGRJYQ/132, createdBy=838a84146, createdName=saharadonkey, createdTime=Sat Jul 26 23:19:00 CST 2014, time=2014-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10660, encodeId=59a41066058, content=好,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIT1K5HVp6e14M3lDgTeribfs0NS0dVZvl53ibWm9N1TCxRBM0XgpicgHeORWZmrib5TEIZLr8mvy9Tvw/132, createdBy=1026104176, createdName=superDrZhang, createdTime=Sat Jul 26 15:07:00 CST 2014, time=2014-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1903893, encodeId=d88919038936d, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Mon Jan 13 05:15:00 CST 2014, time=2014-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1442271, encodeId=46a914422e176, content=<a href='/topic/show?id=4989e8938c9' target=_blank style='color:#2F92EE;'>#统计学#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78938, encryptionId=4989e8938c9, topicName=统计学)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=df8a4916199, createdName=siiner, createdTime=Thu Nov 21 05:15:00 CST 2013, time=2013-11-21, status=1, ipAttribution=)]
    2014-07-26 saharadonkey

    题目很吸引人,内容完全是...额.....跟没说一样,方法大家都知道,你倒是举个栗子分析一下啊

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=10675, encodeId=13cb106e5db, content=题目很吸引人,内容完全是...额.....跟没说一样,方法大家都知道,你倒是举个栗子分析一下啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83erCH0VlRzV7nkwya6pUA59besr9ChGrgDiaqibGf7VkCb1x28oPsXicicqCXC7wLGHbQ8zEfUyWgGRJYQ/132, createdBy=838a84146, createdName=saharadonkey, createdTime=Sat Jul 26 23:19:00 CST 2014, time=2014-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10660, encodeId=59a41066058, content=好,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIT1K5HVp6e14M3lDgTeribfs0NS0dVZvl53ibWm9N1TCxRBM0XgpicgHeORWZmrib5TEIZLr8mvy9Tvw/132, createdBy=1026104176, createdName=superDrZhang, createdTime=Sat Jul 26 15:07:00 CST 2014, time=2014-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1903893, encodeId=d88919038936d, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Mon Jan 13 05:15:00 CST 2014, time=2014-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1442271, encodeId=46a914422e176, content=<a href='/topic/show?id=4989e8938c9' target=_blank style='color:#2F92EE;'>#统计学#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78938, encryptionId=4989e8938c9, topicName=统计学)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=df8a4916199, createdName=siiner, createdTime=Thu Nov 21 05:15:00 CST 2013, time=2013-11-21, status=1, ipAttribution=)]
    2014-07-26 superDrZhang

    好,学习了

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=10675, encodeId=13cb106e5db, content=题目很吸引人,内容完全是...额.....跟没说一样,方法大家都知道,你倒是举个栗子分析一下啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83erCH0VlRzV7nkwya6pUA59besr9ChGrgDiaqibGf7VkCb1x28oPsXicicqCXC7wLGHbQ8zEfUyWgGRJYQ/132, createdBy=838a84146, createdName=saharadonkey, createdTime=Sat Jul 26 23:19:00 CST 2014, time=2014-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10660, encodeId=59a41066058, content=好,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIT1K5HVp6e14M3lDgTeribfs0NS0dVZvl53ibWm9N1TCxRBM0XgpicgHeORWZmrib5TEIZLr8mvy9Tvw/132, createdBy=1026104176, createdName=superDrZhang, createdTime=Sat Jul 26 15:07:00 CST 2014, time=2014-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1903893, encodeId=d88919038936d, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Mon Jan 13 05:15:00 CST 2014, time=2014-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1442271, encodeId=46a914422e176, content=<a href='/topic/show?id=4989e8938c9' target=_blank style='color:#2F92EE;'>#统计学#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78938, encryptionId=4989e8938c9, topicName=统计学)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=df8a4916199, createdName=siiner, createdTime=Thu Nov 21 05:15:00 CST 2013, time=2013-11-21, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=10675, encodeId=13cb106e5db, content=题目很吸引人,内容完全是...额.....跟没说一样,方法大家都知道,你倒是举个栗子分析一下啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83erCH0VlRzV7nkwya6pUA59besr9ChGrgDiaqibGf7VkCb1x28oPsXicicqCXC7wLGHbQ8zEfUyWgGRJYQ/132, createdBy=838a84146, createdName=saharadonkey, createdTime=Sat Jul 26 23:19:00 CST 2014, time=2014-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10660, encodeId=59a41066058, content=好,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIT1K5HVp6e14M3lDgTeribfs0NS0dVZvl53ibWm9N1TCxRBM0XgpicgHeORWZmrib5TEIZLr8mvy9Tvw/132, createdBy=1026104176, createdName=superDrZhang, createdTime=Sat Jul 26 15:07:00 CST 2014, time=2014-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1903893, encodeId=d88919038936d, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Mon Jan 13 05:15:00 CST 2014, time=2014-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1442271, encodeId=46a914422e176, content=<a href='/topic/show?id=4989e8938c9' target=_blank style='color:#2F92EE;'>#统计学#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78938, encryptionId=4989e8938c9, topicName=统计学)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=df8a4916199, createdName=siiner, createdTime=Thu Nov 21 05:15:00 CST 2013, time=2013-11-21, status=1, ipAttribution=)]
    2013-11-21 siiner