Randomised controlled trials and clinical maternity care moving on from intention-to-treat and other simplistic analyses of efficacy 英文参考文献.docVIP

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Randomised controlled trials and clinical maternity care moving on from intention-to-treat and other simplistic analyses of efficacy 英文参考文献.doc

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Randomised controlled trials and clinical maternity care moving on from intention-to-treat and other simplistic analyses of efficacy 英文参考文献

AWBMCPregnancyandChildbirth2013,13:15 /1471-2393/13/15 DEBATE OpenAccess Randomisedcontrolledtrialsandclinical maternitycare:movingonfromintention-to-treat andothersimplisticanalysesofefficacy WelshAW1,2,3 Abstract Background:TheobstetricalliteratureisdominatedbyRandomisedControlledTrials(RCTs),withthevastmajority beinganalysedusinganintention-to-treat(ITT)approach.Whilstthisapproachmayreflectwelltheconsequenceof assignmenttotherapyandhencethe‘trialists’perspective’,itmayfailtoaddresstheconsequenceofactually receivingtherapy(thepatient’ sperspective). Discussion:ThisreviewquestionstheubiquitousadherencetotheITTapproach,andgivesexamplesofwherethis mayhavemisledthematernitycareprofessions.Itgivesanoverviewoftechniquestoovercomepotential deficienciesinresultpresentation,usingmethodeffectivenessmodelssuchas‘PerProtocol’(PP)or‘As-Treated’(AT) thatmaygivemoreaccurateclinicalmeaningtothepresentationofobstetricalresults.Itthenproceedstocover theaddedbenefits,considerationsandpotentialpitfallsoftheuseofInstrumentalVariable(IV)modelsinorderto betterreflecttheclinicalcontext. Summary:WhileITTmayachievestatisticalpurity,itfrequentlyfailstoaddressthetrueclinicalorpatient’s perspective.Thoughmorecomplexandpotentiallybesetbyproblemsoftheirown,alternativemethodsofresult presentationmaybetterservethelatteraim.Eachoftheothermethodsmayrelyonuntestableassumptionsand thereforeitiswisestthatstudyresultsarepresentedinmultipleformatstoallowforinformedreaderevaluation. Keywords:RCT,ITT,Method-effectiveness,Clinicalefficacy,Clinicaleffectiveness,Instrumentalvariable Background Intention-to-treat (ITT)analysis betweentreatmentgroups[7],thoughallpatientsmustbe followedaccordingtoaprespecifiedscheduleofoutcome Inthehierarchyofstatisticaltrials,theRCThasbeenon measurementsregardlessofcompliance,adverseeffectsor the throne for over half a century [1]. Bradford-Hill is otherpostrandomisationobservations[8]. creditedwithprovisionof ‘criteria’inferringcausation[2], Randomisation and adher