04吴崇胜教授-从统计分析的视角看数据标准化与医学编码 - Victor 2017-09-01

看准化与医学编码VictorWu吴崇胜2017-09-01victor.wu@吴崇胜CDISC官方认证培训师CDISC中国协调委员会主席北京迪时咨询有限公司执行副总经理VictorWuCDISCAuthorizedInstructorChair,ChinaCDISCCoordinatingCommitteeExecutiveVicePresidentBeijingDataScienceExpressConsultingCo.,ltd2ØWhereisdataneeded?在哪？ØWhatdoseitmean?!啥意思?!ØThedatawascodedindifferentway,axd222.xptXBaxd222.xptXB0001100001210001310001400001513汇总分析?!ØStructuredData(结构化数据)vsFreeText(自由文本)？集数据ØAEorCM:torequirestandardizedterm?不良事件和合并用药的采集，要不要要求填标准化语4LEMS5剂量增加剂量不变剂量增加剂量不变剂量降低药不适用不知道ACN对研究药物采取的措施DOSEINCREASEDDOSENOTCHANGEDDOSEREDUCEDDRUGINTERRUPTEDDRUGWITHDRAWNNOTAPPLICABLEUNKNOWN6TableofContents¡SDTMCodingRelatedVariables¡MedDRAMultiplePathinCDISC77What’sdatastandardsabout?¡AstandardwaytoorganizeandformatstudydataAGEUYEARSYEARSYEARSYEARSAGEUYEARSYEARSYEARSYEARSYEARSYEARSYEARSYEARSYEARSSEXFMMFMFMMMAGE85818484USUBJIDSTUDYIDCDE01CDE01CDE01CDE01CDE01CDE01CDE01CDE01CDE01SUBJID101510231033104710971111111511181130RACEWHITEWHITEWHITEWHITEWHITEASIANWHITEWHITEAMERICANCDE01-701-1023CDE01-701-1033CDE01-701-1047CDE01-701-1097CDE01-701-1111CDE01-701-1115CDE01-701-1118BLACKORAFRICANCDE01-701-11308StandardizedvsNon-standardized9CDISCCoreStandardsØSDTM:StudyDataTabulationModelØCDASH:ClinicalDataAcquisitionStandardsHarmonizationØADaM:AnalysisDataModelØCT:ControlledTerminologyØODM:OperationalDataModelCDISCCoreStandardsandImplementationTherapyAreasImplementationGuideSDTMCDASHADaMta干预事件伴随试验嗜特殊用途用药(CM)人口学(DM) 不良事件(AE)用药(ta干预事件伴随试验嗜特殊用途用药(CM)人口学(DM) 不良事件(AE)用药(EX/EC)受试者元素(SE) 完成情况(DS)好品(SU)受试者访视(SV) 病史(MH)方案偏离(DV)注(CO)备 临床事件(CE) 试验设计试验元素(TE)录(RELREC)试验分组(TA)试验访视(TV)试验入/排标准(TI)试验总结(TS)相关发现(FA)发发现心心电图(EG)不符不符合的入/排标准(IE)实实验室检查(LB)体体格检查(PE)问卷问卷/量表(QS)关关系描述关联记 关联记 药品发放/回收(DA) PK浓度(PC)PKPK参数(PP)SDTMBasicØDomainsareorganizedarounda“Topic”VariablesbyRole–ExampleSubject101hadmildnauseastartingon07Dec2015IdentifierTopicQualifiersTimingUSUBJIDAETERMAESEVAESTDTCausea2015-12-07Example:AdverseEventsExampleUSUBJIDUSUBJIDAESEQAETERMAEDECODAEBODSYSAESTDTCAEENDTCAESEVGASTROINTESTINALDISORDERSSKINANDSUBCUTANEOUSTISSUE-1097PRURITUSSKINANDSUBCUTANEOUSTISSUEPRURITUSGENERALISEDGENERALISEDGENERALDISORDERSANDAPPLICATIONSITEADMINISTRATIONSITEICLESPLICATIONSITEICLES-1015-1097-1097CONDITIONSDISORDERSDISORDERS3321ADAE-AADAE-AOAOCECFLLYYPRURITUSPlaceboGENERALDISORDERSANDAPPLICATIONSITEADMINISTRATIONSITECONDITIONSJan14ebebJan14Jan14ebYYYYYYISEDSKINANDSUBCUTANEOUSTISSUEDISORDERSSKINANDSUBCUTANEOUSTISSUEDISORDERSPLICATIONSITEICLESAEBODSYSASTDTCDE001_GASTROINTESTINALDISORDERSCOD112ERMISEDESEQMar-2014-1015-1097-1097-1097Jan4DTYYVICLESRTASEVEREN3YYY3321TableofContents¡SDTMCodingRelatedVariables¡MultiplePathinCDISC HighLevelGroupTerm(HLGT) HighLevelGroupTerm(HLGT)HighLevelTerm(HLT)MedDRATermsHierarchy PrimarySystemOrganClass(SOC) Secondary PrimarySystemOrganClass(SOC)HighLevelGroupTerm(HLGT) HighLevelTerm(HLT) SDTMVariablesforMedDRACodingTermsVariableNameControlledVariableLabelTypeTerms,CodelistorFormat--TERMReportedTermforthexxCharTopic--MODIFYModifiedReportedTermCharSynonymQualifier--LLTLowestLevelTermCharMedDRAVariableQualifierLowestLevelTermCodeNumMedDRAVariableQualifier--DECODDictionary-DerivedTermCharMedDRASynonymQualifier--PTCDPreferredTermCodeNumMedDRAVariableQualifier--HLTHighLevelTermCharMedDRAVariableQualifierHighLevelTermCodeNumMedDRAVariableQualifier--HLGTHighLevelGroupTermCharMedDRAVariableQualifier--HLGTCDHighLevelGroupTermCodeNumMedDRAVariableQualifier--BODSYSBodySystemorOrganClassNumMedDRAVariableQualifier--BDSYCDBodySystemorOrganClassCodeNumMedDRAVariableQualifier--SOCPrimarySystemOrganClassCharMedDRAVariableQualifier--SOCCDPrimarySystemOrganClassCodeMedDRAVariableQualifierTableofContents¡SDTMCodingRelatedVariables¡MultiplePathinCDISC2020 HighLevelGroupTerm(HLGT) HighLevelGroupTerm(HLGT)HighLevelTerm(HLT)MedDRATermsHierarchy PrimarySystemOrganClass(SOC) Secondary PrimarySystemOrganClass(SOC)HighLevelGroupTerm(HLGT) HighLevelTerm(HLT) 2122SDTMexampleCodedtoprimarySOCSTUDYIDUSUBJIDAESEQAEDECODAEBODSYSAESTDTCAESOC1XYZXYZ-1-0011AutoimmunethyroiditisEndocrinedisorders2008-05-13Endocrinedisorders2XYZXYZ-1-0012DizzinessNervoustemdisorders2008-06-13NervoussystemdisordersSTUDYIDUSUBJIDAESEQAEDECODAEBODSYSAESTDTCAESOC1XYZXYZ-1-0011AutoimmunethyroiditisEndocrinedisorders2008-05-13Endocrinedisorders2XYZXYZ-1-0012DizzinessCardiacdisorders2008-06-13Nervoussystemdisorders23ADaMOption1:rowsforeachcodingpathwUSUBJIDAESAEDECODAEBODSYSAESOCASOCANL0ANL02FL1XYZ-1-0011AutoimmunethyroiditisEndocrinedisordersEndocrinedisordersEndocrinedisordersYY2XYZ-1-0012DizzinessCardiacdisordersNervoussystemdisordersCardiacdisordersY3XYZ-1-0012DizzinessCardiacdisordersNervoussystemdisordersNervoussystemdisordersY4XYZ-2-0021DizzinessVasculardisordersNervoussystemdisordersVasculardisordersY5XYZ-2-0021DizzinessVasculardisordersNervoussystemdisordersNervoussystemdisordersY24w12w123ADaMOption2:splitthedifferentcodingpathsintoseparateADSUSUBJUSUBJIDAESAEDECODAEBODSYSAESOCANL01FLXYZ-1-0011AutoimmunethyroiditisEndocrinedisordersEndocrinedisordersYXYZ-1-0012DizzinessCardiacdisordersNervoussystemdisordersYXYZ-2-0021DizzinessVasculardisordersNervoussystemdisordersYwUSUBJIDAESAEDECODAEBODSYSAESOCANL01FL1XYZ-1-0011AutoimmunethyroiditisEndEndocrinedisordersEndocrinedisordersY2XYZ-1-0012DizzinessCaCardiacdisordersNervoussystemdisordersY3XYZ-2-0021DizzinessVVasculardisordersNervoussystemdisordersY25123Option3:PersonalSuggestion123Splitthedifferentcodingpaths