Evidence-Based Medicine Educational Series Overview

《Evidence-Based Medicine Educational Series Overview》由会员上传分享，免费在线阅读，更多相关内容在学术论文-天天文库。

1、Evidence-Based-MedicineEducationalSeriesRobertA.Harrington,MDKarenPieper,MSDukeClinicalResearchInstituteLesson1Evidence-BasedMedicine:TheBasicConceptsÑBackground/philosophy°WhatisEBM?°Whydoesitmatter?°Whyisitimportanttodrugdevelopment?ÑBasicsofclinicalresearch°Observationalstudiesversusrandomi

2、zedclinicaltrials°Typesoftrials°Concepts(randomization,samplesizes,etc.)ÑOverviewofregulatoryissuesInstructor:RobertA.Harrington,MDDr.Harrington’saccomplishmentsinclude:ÑJoiningtheDukefacultyintheDivisionofCardiologyin1993,whereheiscurrentlyaprofessorofmedicineandaninterventionalcardiologist.Ñ

3、ServingasafacultymemberattheDCRI,whereheisthedirectorofCardiovascularClinicalTrials.ÑAuthoringmultiplepeer-reviewedmanuscripts,reviews,bookchapters,andeditorials.ÑCoeditingthetextbookAntiplateletTherapyinClinicalPractice.ÑServingasassociateeditoroftheAmericanHeartJournalandfellowoftheAmericanC

4、ollegeofCardiologyandoftheSocietyofCardiovascularAngiographyandIntervention.ÑServingastheprogramcommitteechairfortheAmericanCollegeofCardiology’sAnnualScientificSessionin2006.Lesson2StatisticalIssuesintheDesignofaTrial,Part1ÑExperimentaldesign°RandomizedversusnonrandomizedstudiesRev.01/26/2006

5、Evidence-Based-MedicineEducationalSeriesôSimplerandomizationôBlockedrandomizationôStratification°RandomizationprocessôGroupallocationdesignôFactorialdesignôCrossoverdesignôBlindingÑPhasesofastudyLesson3StatisticalIssuesintheDesignofaTrial,Part2ÑEndpoints°“Hard”versus“soft”endpoints°Adjudicatio

6、nofendpoints°Timingofendpoints°Surrogateendpoints°Singleversuscompositeendpoints°IntentiontotreatÑPrimaryversussecondaryhypotheses°MultiplecomparisonsÑCalculatingsamplesizeLesson4InterpretationofMedicalLiteratureStatisticsandStatisticalTermsÑInterpretationofmedicalliterature°Whatneedstoappeari

7、namanuscript°ThingstokeepinmindwhenlookingatdataÑUniqueanalytictoolsstatisticiansmustuseandwhy°Examplesfromclinicaltrialsdata°Examplesfromregistrydata°SubgroupanalysesandtheirdangersÑInterpretationofresults°Tabularresults°Oddsratioplots