Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies Methodological Overview 英文参考文献.docVIP

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Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies Methodological Overview 英文参考文献.doc

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Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies Methodological Overview 英文参考文献

Meta-analysesofAdverseEffectsDataDerivedfrom RandomisedControlledTrialsasComparedto ObservationalStudies:MethodologicalOverview SuGolder1*,YoonK.Loke2,MartinBland3 1Centre for Reviews and Dissemination, University of York, York, United Kingdom, 2School of Medicine, University of East Anglia, Norwich, United Kingdom, 3DepartmentofHealthSciences,UniversityofYork,York,UnitedKingdom Abstract Background: There is considerable debate as to the relative merits of using randomised controlled trial (RCT) data as opposedtoobservationaldatainsystematicreviewsofadverseeffects.Thismeta-analysisofmeta-analysesaimedtoassess thelevelofagreementordisagreementintheestimatesofharmderivedfrommeta-analysisofRCTsascomparedtometa- analysisofobservationalstudies. MethodsandFindings:Searcheswerecarriedoutintendatabasesinadditiontoreferencechecking,contactingexperts, citationsearches,andhand-searchingkeyjournals,conferenceproceedings,andWebsites.Studieswereincludedwherea pooledrelativemeasureofanadverseeffect(oddsratioorriskratio)fromRCTscouldbedirectlycompared,usingtheratio ofoddsratios,withthepooledestimateforthesameadverseeffectarisingfromobservationalstudies.Nineteenstudies, yielding58meta-analyses,wereidentifiedforinclusion.ThepooledratioofoddsratiosofRCTscomparedtoobservational studieswasestimatedtobe1.03(95%confidenceinterval0.93–1.15).Therewaslessdiscrepancywithlargerstudies.The symmetricfunnelplotsuggeststhatthereisnoconsistentdifferencebetweenriskestimatesfrommeta-analysisofRCTdata andthosefrommeta-analysisofobservationalstudies.Inalmostallinstances,theestimatesofharmfrommeta-analysesof thedifferentstudydesignshad95%confidenceintervalsthatoverlapped(54/58,93%).Intermsofstatisticalsignificance,in nearly two-thirds (37/58, 64%), the results agreed (both studies showing a significant increase or significant decrease or bothshowingnosignificantdifference).Inonlyonemeta-analysisaboutoneadverseeffectwasthereopposingstatistical significance. Conclusions:Empiricalevidencefromthisoverviewin