- 1、本文档共55页,可阅读全部内容。
- 2、有哪些信誉好的足球投注网站(book118)网站文档一经付费(服务费),不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
- 3、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。如您付费,意味着您自己接受本站规则且自行承担风险,本站不退款、不进行额外附加服务;查看《如何避免下载的几个坑》。如果您已付费下载过本站文档,您可以点击 这里二次下载。
- 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“版权申诉”(推荐),也可以打举报电话:400-050-0827(电话支持时间:9:00-18:30)。
查看更多
Introduction of Biomedical Statistics in Clinical ResearchJiang Yong MD, MPH, PhDClinical Trial Research Center,Beijing Tiantan Hospital, Capital Medical UniversityOutlineStudy designStudy design methodsClinical trialSamplingBias and ErrorReliability and ValidityData TypesIntroduction of Biostatistical MethodsStatistical significanceAppropriate statistical tests and result interpretationHow to work with statistician Study designStrength of Study Design: The Evidence PyramidFind the highest strength of evidence available to answer your clinical question.Study DesignSelecting the “Best” study designFactors that must be considered Resources: $ cost-effectiveMan power TimeEthnic problemsPatient burdenClinical trial -basic principalsRandomizationRandom sampling – representative, generalizationRandom grouping – comparability ControlBlindingRandomization methodAim: to ensure the comparability of each groupsMaximize /wiki/Statistical_powerstatistical /wiki/Statistical_powerpowerMinimize selection biasMinimize allocation bias (or confounding)Methods:Tossing a coinRandom number tableComputerized random number generator (SAS/Excel/…)Using blocking and/or stratified randomization to avoid imbalanceControlAim : To ensure the comparabilityClassification according to designConcurrent randomized controlBefore-after control / cross-over controlMatching controlNon-randomized controlHistorical controlClassification according to intervention measuresPlacebo controlEffective controlBlindingMasking the identity of the assigned interventionsAim: to avoid potential bias caused by conscious or subconscious factorsClassification:Single blind: patientDouble blind: patient + investigatorTriple blind: patient + investigator + statisticianHow to Blind PatientsPlacebo pill of same size, color, shape as treatmentsham operation sham device such as sham acupunctureCan Blinding Always be Done?In some studies it may be impossible (or unethical) to blinda treatment may have characteristic side effects
文档评论(0)