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.,1,TheGRADEApproachtoRatingtheQualityofEvidenceAVeryBasicIntroduction,CochraneHIV/AIDSGroupUniversityofCalifornia,SanFranciscoMarch2010,.,2,Background:Toomanysystems,Guidelinedevelopersuseabewilderingvarietyofsystemstoratethequalityoftheevidenceunderlyingtheirrecommendations.Asaresult,guidelineusershavefacedchallenges,.,3,Example,Recommendationforuseoforalanticoagulationinpatientswithatrialfibrillationandrheumaticmitralvalvedisease:,Thesameevidencedifferentclassification,.,4,GradingofRecommendationsAssessment,DevelopmentandEvaluation(GRADE),AsystematicmethodofassessingthequalityofstudiesincludedinasystematicreviewanddevelopingrecommendationsorguidelinesbasedupontheevidenceGRADEWorkingGroupformedin2000Aim:todevelopacommon,transparentandsensiblesystemforgradingthequalityofevidenceandthestrengthofrecommendations,.,5,GRADEuptake,AgencyforHealthCareResearchandQuality(AHRQ)AllergicRhinitisinAsthmaGuidelines(ARIA)AmericanCollegeofChestPhysiciansAmericanCollegeofPhysiciansAmericanThoracicSocietyBritishMedicalJournalCanadianAgencyforDrugsandTechnologyinHealthClinicalEvidenceCochraneCollaborationEuropeanSocietyofThoracicSurgeonsInfectiousDiseasesSocietyofAmerica(IDSA)NationalInstituteClinicalExcellence(NICE)UpToDateWorldHealthOrganizationManyotherorganizations,.,6,Qualityofevidence,“Theextenttowhichonecanbeconfidentthatanestimateofeffectorassociationiscorrect.”Authorsofsystematicreviewsgradequalityofabodyofevidenceseparatelyforeachpatient-importantoutcome.Authorsofsystematicreviewsdonotgradetheoverallqualityofevidenceacrossoutcomes:thatistheroleofguidelinedevelopers.,.,7,Determinantsofquality,Studydesigniscriticaltojudgmentsaboutthequalityofevidence.Randomizedtrialsprovide,ingeneral,farstrongerevidencethanobservationalstudiesRigorousobservationalstudiesprovidestrongerevidencethanuncontrolledcaseseries.IntheGRADEapproachtoqualityofevidence:RandomizedtrialswithoutimportantlimitationsprovidehighqualityevidenceObservationalstudieswithoutspecialstrengthsprovidelowqualityevidenceLimitationsorspecialstrengthscan,however,modifythequalityoftheevidenceofbothrandomizedtrialsandobservationalstudies.,.,8,.,9,TheGRADEsystemclassifiesthequalityofevidenceinoneoffourgrades:,.,10,GRADEprofiler(GRADEpro),SoftwaredevelopedbytheGRADEWorkingGroupThreekindsofevidencetables:GRADEevidenceprofileCochraneSummaryofFindings(SoF)tableCochraneOverviewofReviewstableSoFTableisthemostusefulformostCochranereviews,.,11,EvidenceProfilevs.SummaryofFindingsTable,GRADEEvidenceprofileParticularlyusefulforguidelinedevelopersPresentsinformationaboutthebodyofevidence(e.g.numberofstudies),thejudgmentsabouttheunderlyingqualityofevidence,keystatisticalresults,andagradeforthequalityofevidenceforeachoutcomeSummaryofFindingsTableMostrelevantto(anddesignedforusein)CochranereviewsPresentthemainfindingsofasystematicreviewinatransparentandsimpletabularformatProvideskeyinformationconcerningthequalityofevidence,themagnitudeofeffectoftheinterventionsexamined,andthesumofavailabledataonmostimportantoutcomes.,.,12,GRADEEvidenceProfile,Insomeways,moreinstructivethanSoFTablesNotyetfeasibletopresentinCochranereviews(technical/formattingissues)OrientedmoreforpresentationstoguidelinedevelopersMayeventuallybepossibleforuseinCochranereviews.Inthemeantime,useSoFtablesforCochranereviews.,.,13,GRADEevidenceprofile,.,14,SoFTable,Thereare3keycomponentsofaSoFtable:InformationaboutthereviewSummaryofthestatisticalresultsGradeofthequalityofevidence.AuthorsofsystematicreviewscanuseGRADEprotocreateaSoFtableintwoways:ImportmostofthedatafromaRevMan5fileEnterdatamanuallyRegardlessofhowyouenterthedata,youwillneedtoeditdataandmanuallyenteryourassessmentofthequalityofevidenceforeachoutcomeWhenSoFtableisfinished,youcanimportitintoRevMan.,.,15,SoFTable,SoFtablesincludesevencolumns:Outcomes:listofimportantdesirableandundesirableoutcomes(upto7outcomes)Assumedrisk:ameasureofthetypicalburdenoftheseoutcomesCorrespondingrisk:ameasureoftheburdenoftheoutcomesaftertheinterventionisappliedRelativemagnitudeofeffect:fordichotomousoutcomesthetablewillusuallyprovideriskratio,oddsratio,orhazardratioNumberofparticipantsandstudiesaddressingtheseoutcomesRatingofthequalityofevidenceforeachoutcome(whichmayvarybyoutcome)Comments(ifneeded)Footnotes,fortransparencyaboutyourdecision-makingReviewswithmorethanonemaincomparisonrequireseparateSoFtablesforeachcomparison.,.,16,SoFtable,.,17,HowtomakeaSummaryofFindingsTable(over-simplified),OpenGRADEproCreateprofilesImportdatafromRevMan5intoGRADEproCreateSoFtable.AuthormakesdecisionsaboutinformationtopresentandGRADEstheevidenceExporttablefromGRADEproandimportintoRevMan5,.,18,WorkinginGRADEpro,.,19,GRADEprohasanexcellent“Help”file,.,20,GRADEResources,TheCochraneHIV/AIDSGroupmaintainsapagewithmanyarticlesandotherresourcesaboutGRADE:/Cochrane/GRADE,.,21,Referencesforthispresentation:,GuyattGH,OxmanAD,VistGE,KunzR,Falck-YtterY,Alonso-CoelloP,SchnemannHJ;GRADEWorkingGroup.GRADE:anemergingconsensusonratingqualityofevidenceandstrengthofrecommendations.BMJ.2008Apr26;336(7650):924-6.GuyattGH,OxmanAD,KunzR,Falck-YtterY,VistGE,LiberatiA,SchnemannHJ;G
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