如何提高临床研究者的依从性?

2015-07-04 赵一鸣 北京大学第三医院临床流行病学研究中心

小测试:一个临床研究项目的顺利实施,需要多方面的努力,下面的叙述正确的是?A 研究者只要有合理的设计、可靠的研究对象,即可保证研究的顺利进行B 研究者的依从性影响研究项目开展的质量临床研究项目的设计及具体实施直接影响研究的水平和结果。那么我国临床研究项目的开展情况如何呢?近期国家科研管理部门在对部分重大临床研究项目中期检查或终期评审时发现,评审项目的研究设计方案的质量有明显提高

小测试:一个临床研究项目的顺利实施,需要多方面的努力,下面的叙述正确的是?A 研究者只要有合理的设计、可靠的研究对象,即可保证研究的顺利进行B 研究者的依从性影响研究项目开展的质量临床研究项目的设计及具体实施直接影响研究的水平和结果。那么我国临床研究项目的开展情况如何呢?近期国家科研管理部门在对部分重大临床研究项目中期检查或终期评审时发现,评审项目的研究设计方案的质量有明显提高,但项目实施仍存在许多问题,突出表现为研究者不能严格按设计方案执行,导致数据质量下降,即研究者依从性不好。寻找改善研究者依从性的方法是提高部分临床研究项目质量的有效途径。一、数据质量与影响数据质量的环节——“水桶理论”  数据质量是临床研究的生命。所谓数据质量是指用于分析总结的数据能否真实地反映患者身上发生的情况,分析的数据是否按一定要求在相同条件下收集,不同患者的数据之间是否具有同质性,最终获得的数据是否具备合并统计分析的基础。临床研究质量可以借用经济学中的“水桶理论”进行评价。传统木制水桶的侧壁由多条木板围成,盛水多少与每一条木板有关,如果木板的长度参差不齐,盛水的极限

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  1. [GetPortalCommentsPageByObjectIdResponse(id=2032728, encodeId=359d2032e28b2, content=<a href='/topic/show?id=ff85e343730' target=_blank style='color:#2F92EE;'>#研究者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73437, encryptionId=ff85e343730, topicName=研究者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Wed Aug 12 23:16:00 CST 2015, time=2015-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=83581, encodeId=20f1835814e, content=很难吧,必须认真, beContent=null, objectType=article, channel=null, level=null, likeNumber=112, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d231626576, createdName=jjzouyan, createdTime=Tue May 03 07:40:00 CST 2016, time=2016-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34746, encodeId=5df334e46ba, content=这些都是我们当前面临的问题, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:43:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34744, encodeId=63ab34e44c6, content=我觉得这些依从性不可取, beContent=null, objectType=article, channel=null, level=null, likeNumber=124, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:42:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34745, encodeId=442534e4529, content=应该有自己的创新能力, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:42:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32582, encodeId=dc1332582a4, content=不错,参与过一个多中心大型临床试验,这篇文章反映了具体操作的许多问题,值得借鉴, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f1e79214, createdName=fanlei0803, createdTime=Mon Jul 13 09:13:00 CST 2015, time=2015-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1319253, encodeId=10c8131925300, content=<a href='/topic/show?id=60172686668' target=_blank style='color:#2F92EE;'>#依从性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26866, encryptionId=60172686668, topicName=依从性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9df476, createdName=fyxzlh, createdTime=Mon Jul 06 11:16:00 CST 2015, time=2015-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30887, encodeId=a5a13088ecd, content=受教, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=66c61628089, createdName=caierhong, createdTime=Mon Jul 06 08:29:00 CST 2015, time=2015-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30874, encodeId=8c05308e42e, content=嘿嘿?, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dcb01604905, createdName=hcz5759, createdTime=Sun Jul 05 23:39:00 CST 2015, time=2015-07-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30802, encodeId=afc1308021a, content=有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12a31627589, createdName=18619c0a62m, createdTime=Sun Jul 05 16:12:00 CST 2015, time=2015-07-05, status=1, ipAttribution=)]
    2015-08-12 stfoxst
  2. [GetPortalCommentsPageByObjectIdResponse(id=2032728, encodeId=359d2032e28b2, content=<a href='/topic/show?id=ff85e343730' target=_blank style='color:#2F92EE;'>#研究者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73437, encryptionId=ff85e343730, topicName=研究者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Wed Aug 12 23:16:00 CST 2015, time=2015-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=83581, encodeId=20f1835814e, content=很难吧,必须认真, beContent=null, objectType=article, channel=null, level=null, likeNumber=112, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d231626576, createdName=jjzouyan, createdTime=Tue May 03 07:40:00 CST 2016, time=2016-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34746, encodeId=5df334e46ba, content=这些都是我们当前面临的问题, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:43:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34744, encodeId=63ab34e44c6, content=我觉得这些依从性不可取, beContent=null, objectType=article, channel=null, level=null, likeNumber=124, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:42:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34745, encodeId=442534e4529, content=应该有自己的创新能力, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:42:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32582, encodeId=dc1332582a4, content=不错,参与过一个多中心大型临床试验,这篇文章反映了具体操作的许多问题,值得借鉴, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f1e79214, createdName=fanlei0803, createdTime=Mon Jul 13 09:13:00 CST 2015, time=2015-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1319253, encodeId=10c8131925300, content=<a href='/topic/show?id=60172686668' target=_blank style='color:#2F92EE;'>#依从性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26866, encryptionId=60172686668, topicName=依从性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9df476, createdName=fyxzlh, createdTime=Mon Jul 06 11:16:00 CST 2015, time=2015-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30887, encodeId=a5a13088ecd, content=受教, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=66c61628089, createdName=caierhong, createdTime=Mon Jul 06 08:29:00 CST 2015, time=2015-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30874, encodeId=8c05308e42e, content=嘿嘿?, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dcb01604905, createdName=hcz5759, createdTime=Sun Jul 05 23:39:00 CST 2015, time=2015-07-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30802, encodeId=afc1308021a, content=有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12a31627589, createdName=18619c0a62m, createdTime=Sun Jul 05 16:12:00 CST 2015, time=2015-07-05, status=1, ipAttribution=)]
    2016-05-03 jjzouyan

    很难吧,必须认真

    0

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    2015-08-06 hlycom3356

    这些都是我们当前面临的问题

    0

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    2015-08-06 hlycom3356

    我觉得这些依从性不可取

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=2032728, encodeId=359d2032e28b2, content=<a href='/topic/show?id=ff85e343730' target=_blank style='color:#2F92EE;'>#研究者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73437, encryptionId=ff85e343730, topicName=研究者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Wed Aug 12 23:16:00 CST 2015, time=2015-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=83581, encodeId=20f1835814e, content=很难吧,必须认真, beContent=null, objectType=article, channel=null, level=null, likeNumber=112, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d231626576, createdName=jjzouyan, createdTime=Tue May 03 07:40:00 CST 2016, time=2016-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34746, encodeId=5df334e46ba, content=这些都是我们当前面临的问题, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:43:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34744, encodeId=63ab34e44c6, content=我觉得这些依从性不可取, beContent=null, objectType=article, channel=null, level=null, likeNumber=124, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:42:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34745, encodeId=442534e4529, content=应该有自己的创新能力, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:42:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32582, encodeId=dc1332582a4, content=不错,参与过一个多中心大型临床试验,这篇文章反映了具体操作的许多问题,值得借鉴, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f1e79214, createdName=fanlei0803, createdTime=Mon Jul 13 09:13:00 CST 2015, time=2015-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1319253, encodeId=10c8131925300, content=<a href='/topic/show?id=60172686668' target=_blank style='color:#2F92EE;'>#依从性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26866, encryptionId=60172686668, topicName=依从性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9df476, createdName=fyxzlh, createdTime=Mon Jul 06 11:16:00 CST 2015, time=2015-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30887, encodeId=a5a13088ecd, content=受教, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=66c61628089, createdName=caierhong, createdTime=Mon Jul 06 08:29:00 CST 2015, time=2015-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30874, encodeId=8c05308e42e, content=嘿嘿?, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dcb01604905, createdName=hcz5759, createdTime=Sun Jul 05 23:39:00 CST 2015, time=2015-07-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30802, encodeId=afc1308021a, content=有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12a31627589, createdName=18619c0a62m, createdTime=Sun Jul 05 16:12:00 CST 2015, time=2015-07-05, status=1, ipAttribution=)]
    2015-08-06 hlycom3356

    应该有自己的创新能力

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=2032728, encodeId=359d2032e28b2, content=<a href='/topic/show?id=ff85e343730' target=_blank style='color:#2F92EE;'>#研究者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73437, encryptionId=ff85e343730, topicName=研究者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Wed Aug 12 23:16:00 CST 2015, time=2015-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=83581, encodeId=20f1835814e, content=很难吧,必须认真, beContent=null, objectType=article, channel=null, level=null, likeNumber=112, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d231626576, createdName=jjzouyan, createdTime=Tue May 03 07:40:00 CST 2016, time=2016-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34746, encodeId=5df334e46ba, content=这些都是我们当前面临的问题, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:43:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34744, encodeId=63ab34e44c6, content=我觉得这些依从性不可取, beContent=null, objectType=article, channel=null, level=null, likeNumber=124, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:42:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=34745, encodeId=442534e4529, content=应该有自己的创新能力, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 10:42:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32582, encodeId=dc1332582a4, content=不错,参与过一个多中心大型临床试验,这篇文章反映了具体操作的许多问题,值得借鉴, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f1e79214, createdName=fanlei0803, createdTime=Mon Jul 13 09:13:00 CST 2015, time=2015-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1319253, encodeId=10c8131925300, content=<a href='/topic/show?id=60172686668' target=_blank style='color:#2F92EE;'>#依从性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26866, encryptionId=60172686668, topicName=依从性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9df476, createdName=fyxzlh, createdTime=Mon Jul 06 11:16:00 CST 2015, time=2015-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30887, encodeId=a5a13088ecd, content=受教, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=66c61628089, createdName=caierhong, createdTime=Mon Jul 06 08:29:00 CST 2015, time=2015-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30874, encodeId=8c05308e42e, content=嘿嘿?, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dcb01604905, createdName=hcz5759, createdTime=Sun Jul 05 23:39:00 CST 2015, time=2015-07-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=30802, encodeId=afc1308021a, content=有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12a31627589, createdName=18619c0a62m, createdTime=Sun Jul 05 16:12:00 CST 2015, time=2015-07-05, status=1, ipAttribution=)]
    2015-07-13 fanlei0803

    不错,参与过一个多中心大型临床试验,这篇文章反映了具体操作的许多问题,值得借鉴

    0

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    2015-07-06 fyxzlh
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    2015-07-06 caierhong

    受教

    0

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    2015-07-05 hcz5759

    嘿嘿?

    0

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    2015-07-05 18619c0a62m

    有用

    0

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