循证手册.docx
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循证手册.docx
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循证手册
1.2.2 Whatisasystematicreview?
Asystematicreviewattemptstocollateallempiricalevidencethatfitspre-specifiedeligibilitycriteriainordertoansweraspecificresearchquestion. It usesexplicit,systematicmethodsthatareselectedwithaviewtominimizingbias,thusprovidingmorereliablefindingsfromwhichconclusionscanbedrawnanddecisionsmade(Antman1992,Oxman1993).Thekeycharacteristicsofasystematicrevieware:
∙aclearlystatedsetofobjectiveswithpre-definedeligibilitycriteriaforstudies;
∙anexplicit,reproduciblemethodology;
∙asystematicsearchthatattemptstoidentifyallstudiesthatwouldmeettheeligibilitycriteria;
∙anassessmentofthevalidityofthefindingsoftheincludedstudies,forexamplethroughtheassessmentofriskofbias;and
∙asystematicpresentation,andsynthesis,ofthecharacteristicsandfindingsoftheincludedstudies.
Manysystematicreviewscontainmeta-analyses.Meta-analysisistheuseofstatisticalmethodstosummarizetheresultsofindependentstudies(Glass1976).Bycombininginformationfromallrelevantstudies,meta-analysescanprovidemorepreciseestimatesoftheeffectsofhealthcarethanthosederivedfromtheindividualstudiesincludedwithinareview(seeChapter9,Section9.1.3).Theyalsofacilitateinvestigationsoftheconsistencyofevidenceacrossstudies,andtheexplorationofdifferencesacrossstudies.
2.1 Rationaleforprotocols
PreparingaCochranereviewiscomplexandinvolvesmanyjudgements.Inordertominimizethepotentialforbiasinthereviewprocess,thesejudgementsshouldbemadeinwaysthatdonotdependonthefindingsofthestudiesincludedinthereview.Reviewauthors’priorknowledgeoftheresultsofapotentiallyeligiblestudymay,forexample,influencethedefinitionofasystematicreviewquestion,thesubsequentcriteriaforstudyeligibility,thechoiceofinterventioncomparisonstoanalyse,ortheoutcomestobereportedinthereview.SinceCochranereviewsarebytheirnatureretrospective(oneexceptionbeingprospectivemeta-analyses,asdescribedinChapter19),itisimportantthatthemethodstobeusedshouldbeestablishedanddocumentedinadvance.Publicationofaprotocolforareviewpriortoknowledgeoftheavailablestudiesreducestheimpactofreviewauthors’biases,promotestransparencyofmethodsandprocesses,reducesthepotentialforduplication,andallowspeerreviewoftheplannedmethods(Light1984).
Whiletheintentionshouldbethatareviewwilladheretothepublishedprotocol,changesinareviewprotocolaresometimesnecessary.Thisissimilarlythecaseforaprotocolforarandomizedtrial,whichmustsometimesbechangedtoadapttounanticipatedcircumstancessuchasproblemswithparticipantrecruitment,datacollectionorunexpectedeventrates.Whileeveryeffortshouldbemadetoadheretoapredeterminedprotocol,thisisnotalwayspossibleorappropriate.Itisimportant,however,thatchangesintheprotocolshouldnotbemadeonthebasisofhowtheyaffecttheoutcomeoftheresearchstudy.Posthocdecisionsmadewhentheimpactontheresultsoftheresearchisknown,suchasexcludingselectedstudiesfromasystematicreview,arehighlysusceptibletobiasandshouldbeavoided.
ProtocolsforCochranereviewsarepublishedbeforethecompletedsystematicreviewintheCochraneDatabaseofSystematicReviews(CDSR).Changesintheprotocolshouldbedocumentedandreportedinthe‘Differencesbetweenprotocolandreview’sectionofthecompletedreview,andsensitivityanalyses(seeChapter9,Section9.7)exploringtheimpactofdeviationsfromtheprotocolshouldbeundertakenwhenpossible
2.2.1 RationalefortheformatofaCochranereview
AllCochranereviewsofinterventionshavethesameformat.Benefitsofthisuniformformatinclude:
1.helpingreadersfindtheresultsofresearchquicklyandtoassessthevalidity,applicabilityandimplicationsofthoseresults;
2.guidingreviewauthorstoreporttheirworkexplicitlyandconcisely,andminimizingtheeffortrequiredtodothis;
3.facilitatingelectronicpublicationandmaintenanceofreviews;and
4.enablingthedevelopmentofderivativeproducts(e.g.Overviewsofreviews,seeChapter22)andempiricalresearchstudiesbasedonmultiplesystematicreviews.
Theformatisflexibleenoughtofitdifferenttypesofreviews,includingthosemakingasinglecomparison,thosemakingmultiplecomparisonsandthosepreparedusingindividualpatientdata.StandardheadingsandtablesembeddedinRevManguidereviewauthorswhenpreparingtheirreportandmakeiteasierforreaderstoidentifyinformationthatisofparticularinteresttothem.TheheadingswithinRevManarelistedinSections2.2.2and2.2.3.AdetailedguidetothecontentthatshouldfolloweachheadingisprovidedinChapter4.
2.2.2 OutlineofaprotocolforaCochranereview
Box2.2.aliststheelementsthatdefineacompleteprotocolforaCochranereview,andindicatehowtheprotocolislikelytoappearintheCDSR(whichmaynotbethesameasinRevMan).Ifanyofthesectionsmarkedwithanasterisk(*)areempty,theprotocolwillnotbepublisheduntilsomethinghasbeenaddedtothesection,thatistheyare‘mandatoryfields’.
Box2.2.a:
SectionsofaprotocolforaCochranereview
Title*
Protocolinformation:
Authors*
Contactperson*
Dates
What’snew
History
Theprotocol:
Background*
Objectives*
Methods:
Criteriaforselectingstudiesforthisreview:
Typesofstudies*
Typesofparticipants*
Typesofinterventions*
Typesofoutcomemeasures*
Searchmethodsforidentificationofstudies*
Datacollectionandanalysis*
Acknowledgements
References:
Otherreferences:
Additionalreferences
Otherpublishedversionsofthisreview
Tablesandfigures:
Additionaltables
Figures
Supplementaryinformation:
Appendices
Feedback:
Title
Summary
Reply
Contributors
Aboutthearticle:
Contributionsofauthors
Declarationsofinterest*
Sourcesofsupport:
Internalsources
Externalsources
Publishednotes
2.2.3 DetailedoutlineofaCochranereview
Box2.2.bliststheelementsthatdefineacompleteCochranereview,andindicatehowthereviewislikelytoappearintheCDSR(whichmaynotbethesameasinRevMan).Ifanyofthesectionsmarkedwithanasterisk(*)areempty,thereviewwillnotbepublisheduntilsomethinghasbeenaddedtothesection,thatistheyare‘mandatoryfields’.
Box2.2.b:
SectionsofaCochranereview
Title*
Reviewinformation:
Authors*
Contactperson*
Dates*
What’snew
History
Abstract:
Background*
Objectives*
Searchmethods*
Datacollectionandanalysis*
Results*
Authors’conclusions*
Plainlanguagesummary:
Plainlanguagetitle*
Summarytext*
Thereview:
Background*
Objectives*
Methods:
Criteriaforselectingstudiesforthisreview:
Typesofstudies*
Typesofparticipants*
Typesofinterventions*
Typesofoutcomemeasures*
Searchmethodsforidentificationofstudies*
Datacollectionandanalysis*
Results:
Descriptionofstudies*
Riskofbiasinincludedstudies*
Effectsofinterventions*
Discussion*
Authors’conclusions:
Implicationforpractice*
Implicationforresearch*
Acknowledgements
References:
Referencestostudies:
Includedstudies
Excludedstudies
Studiesawaitingclassification
Ongoingstudies
Otherreferences:
Additionalreferences
Otherpublishedversionsofthisreview
Tablesandfigures:
Characteristicsofstudies:
Characteristicsofincludedstudies(includes‘Riskofbias’tables)
Characteristicsofexcludedstudies
Characteristicsofstudiesawaitingassessment
Characteristicsofongoingstudies
‘Summaryoffindings’tables
Additionaltables
Figures
Supplementaryinformation:
Dataandanalyses
Appendices
Feedback:
Title
Summary
Reply
Contributors
Aboutthearticle:
Contributionsofauthors
Declarationsofinterest*
Differencesbetweenprotocolandreview
Sourcesofsupport:
Internalsources
Externalsources
Publishednotes
2.3 Logisticsofdoingareview
2.3.1Motivationforundertakingareview
2.3.2Planningthetopicandscopeofareview
2.3.3Registeringaprotocol
2.3.4Thereviewteam
2.3.5CochranesoftwareforreviewauthorsandeditorialbasesofCochraneReviewGroups
2.3.6Training
2.3.7EditorialproceduresofaCochraneReviewGroup
2.3.8Resource
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