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我的设计我做主:MedSci临床研究方案设计活动-立题公布(2)

2015-05-13 MedSci MedSci原创

前提示:【我的设计我做主】MedSci临床研究方案设计活动-立题公布(1)对于肥胖或体重超标者实施体重控制或干预(减轻体重)对于IVF妊娠结局的影响对于肥胖或体重超标者实施体重控制或干预(减轻体重)对于IVF妊娠结局的影响 相关的研究成果不少(fig 1 Pubmed上粗略的检索结果),正在进行或已经结束的注册研究也有一些(fig 2 www.clinicaltrials.gov上注册的研究,


对于肥胖或体重超标者实施体重控制或干预(减轻体重)对于IVF妊娠结局的影响

对于肥胖或体重超标者实施体重控制或干预(减轻体重)对于IVF妊娠结局的影响 相关的研究成果不少(fig 1 Pubmed上粗略的检索结果),正在进行或已经结束的注册研究也有一些(fig 2 www.clinicaltrials.gov上注册的研究,fig 3 注册研究分布的国家、地区)。 

此类研究在中国乃至亚洲地区均未有注册研究,因此如果本课题成立,并进行注册,也可能是国内最早注册的相关研究方案之一。 此类研究设计有一定的“规律”可循,如果最后选择这个方向,我们会在“任务二•研究类型的选择”中与大家进行探讨。 

分析这个立题,我们不难发现有几个关键词,即“肥胖或体重超标”、“体重控制或干预”、“结局”。那么对于研究立题的完善或者细化,我们就应该从这三个方面进行: 

1. 肥胖或体重超标:需要根据“指南”、“共识”或同行标准进行定义,建议大家借此机会进行复习。 这个“定义”还有一个关键点,即何时定义为肥胖或体重超标,应该对纳入研究的对象进行体重或BMI测量,并且应该规定同一时间的测量结果进行记录。这一点一定要在方案中注明。 

2. 体重控制或干预:这里需要包括干预方案,如饮食、运动、药物等;还要考虑是否干预?是否都实施干预?如果不进行干预或无法干预,进行观察性研究是否可行?如果干预,如何评价干预效果? 

3. 结局:体重结局是一定要在本研究中进行评估的,而且也要注意测量的时间点保持一致的问题。其他的IVF结局大家可以进行选择,这个并不困难。 

针对上述问题,我们可以结合一个案例,进一步的理解: 


这是一个非常简单的研究设计,而且不需要很大的样本量,很适合临床医生进行操作,值得大借鉴。当然,这也不是一个“完美”的设计,如没有进行随机分组,干预措施制定和实施监测等细节,受限于“观察性研究”,控制得并不严格。不过这个研究的结果还是值得我们借鉴的。最后,如果我们最终选择这个立题,那么请老师思考一下,我们怎么去完善和细化“肥胖或体重超标”、“体重控制或干预”、“结局”。凡是参与者皆能获取积分奖励,最佳参与者更能获得200的MedSci学院积分



 Figure 1 Pubmed上粗略的检索结果(检索“(obsesity OR overweight) and IVF”,限定clinical trail) 


 Figure 2 www.clinicaltrials.gov上注册的研究 https://www.clinicaltrials.gov/ct2/results?term=obesity+and+IVF&Search=Search 


 Figure 3注册研究分布的国家、地区

欢迎本领域的老师参加,想加入此微信群的老师,请直接联系管理员:大M(medsci_s),他会为您引荐。

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    2015-05-23 jasonuclear

    认真学习

    0

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    2015-05-17 huaxipanxing

    看看

    0

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    2015-05-13 182.149.192.**

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