GRADE系统简介Cochrane.pptx

The GRADE ApproachThe GRADE Approachto Rating the Quality of Evidenceto Rating the Quality of EvidenceA Very Basic IntroductionA Very Basic IntroductionCochrane HIV/AIDS GroupCochrane HIV/AIDS GroupUniversity of California,San FranciscoUniversity of California,San FranciscoMarch 2010March 2010Background:Too many systemsBackground:Too many systemsGuideline developers use a bewildering variety of systems to rate the quality of the evidence underlying their recommendations.As a result,guideline users have faced challenges ExampleExampleRecommendation for use of oral anticoagulation in patients with Recommendation for use of oral anticoagulation in patients with atrial fibrillation and rheumatic mitral valve disease:atrial fibrillation and rheumatic mitral valve disease:ORGANIZATIONORGANIZATIONEVIDENCEEVIDENCERECOMMENDATIONRECOMMENDATIONAmerican Heart American Heart Association(AHA)Association(AHA)B BClass IClass IAmerican College of American College of Clinical Pharmacy Clinical Pharmacy(ACCP)(ACCP)A A1 1Scottish Scottish Intercollegiate Intercollegiate Guidelines Network Guidelines Network(SIGN)(SIGN)IVIVC CThe same evidence different classificationThe same evidence different classificationGrading of Recommendations Grading of Recommendations Assessment,Development and Evaluation Assessment,Development and Evaluation(GRADE)(GRADE)A systematic method of assessing the quality of studies included in a systematic review and developing recommendations or guidelines based upon the evidenceGRADE Working Group formed in 2000Aim:to develop a common,transparent and sensible system for grading the quality of evidence and the strength of recommendationsGRADE uptakeGRADE uptakeAgency for Health Care Research and Quality(AHRQ)Allergic Rhinitis in Asthma Guidelines(ARIA)American College of Chest PhysiciansAmerican College of PhysiciansAmerican Thoracic SocietyBritish Medical JournalCanadian Agency for Drugs and Technology in HealthClinical EvidenceCochrane CollaborationEuropean Society of Thoracic SurgeonsInfectious Diseases Society of America(IDSA)National Institute Clinical Excellence(NICE)UpToDateWorld Health OrganizationMany other organizationsQuality of evidenceQuality of evidence“The extent to which one can be confident that an estimate of effect or association is correct.”Authors of systematic reviews grade quality of a body of evidence separately for each patient-important outcome.Authors of systematic reviews do not grade the overall quality of evidence across outcomes:that is the role of guideline developers.Determinants of qualityDeterminants of qualityStudy design is critical to judgments about the quality of evidence.Randomized trials provide,in general,far stronger evidence than observational studiesRigorous observational studies provide stronger evidence than uncontrolled case series.In the GRADE approach to quality of evidence:In the GRADE approach to quality of evidence:Randomized trials without important limitations provide high quality evidence Observational studies without special strengths provide low quality evidence Limitations or special strengths can,however,modify the quality of the evidence of both randomized trials and observational studies.The GRADE system classifies the quality of The GRADE system classifies the quality of evidence in one of four grades:evidence in one of four grades:GRADEGRADEDEFINITIONDEFINITIONHighHighFurther research is very unlikely to change our Further research is very unlikely to change our confidence in the estimate of effect.confidence in the estimate of effect.ModerateModerateFurther research is likely to have an important impact on Further research is likely to have an important impact on our confidence in the estimate of effect and may change our confidence in the estimate of effect and may change the estimate.the estimate.LowLowFurther research is very likely to have an important Further research is very likely to have an important impact on our confidence in the estimate of effect and is impact on our confidence in the estimate of effect and is likely to change the estimate.likely to change the estimate.Very LowVery Low Any estimate of effect is very uncertain.Any estimate of effect is very uncertain.GRADEprofiler(GRADEpro)GRADEprofiler(GRADEpro)Software developed by the GRADE Working GroupSoftware developed by the GRADE Working GroupThree kinds of evidence tables:Three kinds of evidence tables:GRADE evidence profile Cochrane Summary of Findings(SoF)table Cochrane Overview of Reviews table SoF Table is the most useful for most Cochrane reviewsSoF Table is the most useful for most Cochrane reviewsEvidence Profile vs.Evidence Profile vs.Summary of Findings TableSummary of Findings TableGRADE Evidence profileGRADE Evidence profileParticularly useful for guideline developersPresents information about the body of evidence(e.g.number of studies),the judgments about the underlying quality of evidence,key statistical results,and a grade for the quality of evidence for each outcomeSummary of Findings TableSummary of Findings TableMost relevant to(and designed for use in)Cochrane reviewsPresent the main findings of a systematic review in a transparent and simple tabular formatProvides key information concerning the quality of evidence,the magnitude of effect of the interventions examined,and the sum of available data on most important outcomes.GRADE Evidence ProfileGRADE Evidence ProfileIn some ways,more instructive than SoF TablesIn some ways,more instructive than SoF TablesNot yet feasible to present in Cochrane reviews Not yet feasible to present in Cochrane reviews(technical/formatting issues)(technical/formatting issues)Oriented more for presentations to guideline developersOriented more for presentations to guideline developersMay eventually be possible for use in Cochrane reviews.May eventually be possible for use in Cochrane reviews.In the mean time,use SoF tables for Cochrane reviews.In the mean time,use SoF tables for Cochrane reviews.GRADEGRADEevidenceevidenceprofileprofileSoF TableSoF TableThere are 3 key components of a SoF table:There are 3 key components of a SoF table:Information about the review Summary of the statistical results Grade of the quality of evidence.Authors of systematic reviews can use GRADEpro to create a SoF Authors of systematic reviews can use GRADEpro to create a SoF table in two ways:table in two ways:Import most of the data from a RevMan 5 file Enter data manuallyRegardless of how you enter the data,you will need to edit data and Regardless of how you enter the data,you will need to edit data and manually enter your assessment of the quality of evidence for each manually enter your assessment of the quality of evidence for each outcomeoutcomeWhen SoF table is finished,you can import it into RevMan.When SoF table is finished,you can import it into RevMan.SoF TableSoF TableSoF tables include seven columns:SoF tables include seven columns:Outcomes:Outcomes:list of important desirable and undesirable outcomes(up to 7 outcomes)Assumed risk:Assumed risk:a measure of the typical burden of these outcomesCorresponding risk:Corresponding risk:a measure of the burden of the outcomes after the intervention is appliedRelative magnitude of effect:Relative magnitude of effect:for dichotomous outcomes the table will usually provide risk ratio,odds ratio,or hazard ratio Number of participants and studiesNumber of participants and studies addressing these outcomes Rating of the quality of evidence for each outcomeRating of the quality of evidence for each outcome(which may vary by outcome)CommentsComments(if needed)Footnotes,for transparency about your decision-makingFootnotes,for transparency about your decision-makingReviews with more than one main comparison require separate SoF Reviews with more than one main comparison require separate SoF tables for each comparison.tables for each comparison.SoFSoFtabletableHow to make a How to make a Summary of Findings TableSummary of Findings Table(over-simplified)(over-simplified)Open GRADEpro Open GRADEpro Create profilesCreate profilesImport data from RevMan 5 into GRADEproImport data from RevMan 5 into GRADEproCreate SoF table.Author makes decisions about Create SoF table.Author makes decisions about information to present and GRADEs the evidenceinformation to present and GRADEs the evidenceExport table from GRADEpro and import into RevMan 5Export table from GRADEpro and import into RevMan 5Working Working in in GRADEproGRADEproGRADEpro has an excellent“Help”fileGRADEpro has an excellent“Help”fileGRADE ResourcesGRADE ResourcesThe Cochrane HIV/AIDS Group maintains a page with The Cochrane HIV/AIDS Group maintains a page with many articles and other resources about GRADE:many articles and other resources about GRADE:www.igh.org/Cochrane/GRADEReferences for this presentation:References for this presentation:Guyatt GH,Oxman AD,Vist GE,Kunz R,Falck-Ytter Y,Alonso-Coello P,Schnemann HJ;GRADE Working Group.GRADE:an emerging consensus on rating quality of evidence and strength of recommendations.BMJ.2008 Apr 26;336(7650):924-6.Guyatt GH,Oxman AD,Kunz R,Falck-Ytter Y,Vist GE,Liberati A,Schnemann HJ;GRADE Working Group.Going from evidence to recommendations.BMJ.2008 May 10;336(7652):1049-51.Schnemann H,Broek J,Oxman A,editors.GRADE handbook for grading quality of evidence and strength of recommendations.Version 3.2 updated March 2009.The GRADE Working Group,2009.Available from http:/www.cc- H.Preparing Summary of Findings tables for Cochrane Reviews(PowerPoint presentation).Cochrane Applicability and Recommendations Methods Group,2008.GRADE Working Group:http:/www.gradeworkinggroup.orgSturt AS,Dokubo EK,Sint TT.Antiretroviral therapy(ART)for treating HIV infection in ART-eligible pregnant women.Cochrane Database of Systematic Reviews,2010:3(forthcoming)