临床研究方案设计中的几个常见问题和解决方法

2014-06-26 王小钦, 林果为, 张骏延 中华内科杂志

科研设计决定了临床研究的质量和科研水平,没有严谨的设计,不但达不到预期的结果,还会产生错误的结论,误导临床医师和广大患者,也浪费宝贵的时间和科研 经费,所以研究者在进行科研之前一定要花比较多的时间考虑科研设计问题,必须有完整的设计方案后再动手做研究,而不能“想到什么就做什么,做到哪步算哪 步”。 主要包括如下问题:(1)研究类型定义

科研设计决定了临床研究的质量和科研水平,没有严谨的设计,不但达不到预期的结果,还会产生错误的结论,误导临床医师和广大患者,也浪费宝贵的时间和科研经费,所以研究者在进行科研之前一定要花比较多的时间考虑科研设计问题,必须有完整的设计方案后再动手做研究,而不能“想到什么就做什么,做到哪步算哪步”。 主要包括如下问题:(1)研究类型定义不清楚或错误(2)主要与次要终点定义不清晰(3)没有科学假设(4)没有对照,或对照不合理(5)名义上的随机对照研究(6)没有计算样本量原始出处:王小钦, 林果为, 张骏延. 临床研究方案设计中的几个常见问题和解决方法[J]. 中华内科杂志, 2014, 53(4): 262-264.

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  3. [GetPortalCommentsPageByObjectIdResponse(id=2016215, encodeId=758a201621532, content=<a href='/topic/show?id=5fc458e751c' target=_blank style='color:#2F92EE;'>#方案设计#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58775, encryptionId=5fc458e751c, topicName=方案设计)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3860283, createdName=whmdzju, createdTime=Sun Oct 26 08:54:00 CST 2014, time=2014-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688738, encodeId=7ecd1688e38ed, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Wed Jul 30 23:54:00 CST 2014, time=2014-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10866, encodeId=0e5310866c8, content=图总结得很清晰, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69bd13185, createdName=hygeia1019, createdTime=Tue Aug 05 11:49:00 CST 2014, time=2014-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10554, encodeId=3dab1055468, content=样本量怎么计算呢?, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=51b9105133, createdName=qing1231990, createdTime=Mon Jul 21 01:26:00 CST 2014, time=2014-07-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10487, encodeId=e4c61048e45, content=有无干预,是否随机,有无对照, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2d2103784, createdName=chen111111, createdTime=Tue Jul 15 23:12:00 CST 2014, time=2014-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1374240, encodeId=cb3a13e424010, content=<a href='/topic/show?id=8671486541a' target=_blank style='color:#2F92EE;'>#常见问题#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48654, encryptionId=8671486541a, topicName=常见问题)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5e30378, createdName=caobinglei8079, createdTime=Sat Jun 28 10:54:00 CST 2014, time=2014-06-28, status=1, ipAttribution=)]
    2014-08-05 hygeia1019

    图总结得很清晰

    0

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    2014-07-21 qing1231990

    样本量怎么计算呢?

    0

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    2014-07-15 chen111111

    有无干预,是否随机,有无对照

    0

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