Consort-CONSORT2010

Thechecklistincludesthe25itemsselectedbecauseempiricalevidenceindicatesthatnotreportingtheinformationisassociatedwithbiasedestimatesoftreatmenteffect,orbecausetheinformationisessentialtojudgethereliabilityorrelevanceofthefindings.

ThechecklistitemspertaintothecontentoftheTitle,Abstract,Introduction,Methods,Results,Discussion,andOtherinformation.Youcanexplorethedetailsoftheseitems,asfoundintheCONSORT2018ExplanationandElaborationdocument,byclickingontherelevantchecklistitemtitlesbelow.TheselinkswillopenadynamicapplicationwehavecreatedthatallowsyoutoexploreandinteractwiththeCONSORTchecklistandallofitsextensions.

TemplatesoftheCONSORT2018checklistareavailabletodownloadinand.

TitleandAbstract

Identificationasarandomisedtrialinthetitle.

Structuredsummaryoftrialdesign,methods,results,andconclusions

Introduction

Scientificbackgroundandexplanationofrationale

Specificobjectivesorhypothesis

Methods

Descriptionoftrialdesign(suchasparallel,factorial)includingallocationratio

Importantchangestomethodsaftertrialcommencement(suchaseligibilitycriteria),withreasons

Eligibilitycriteriaforparticipants

Settingsandlocationswherethedatawerecollected

Theinterventionsforeachgroupwithsufficientdetailstoallowreplication,includinghowandwhentheywereactuallyadministered

Completelydefinedpre-specifiedprimaryandsecondaryoutcomemeasures,includinghowandwhentheywereassessed

Anychangestotrialoutcomesafterthetrialcommenced,withreasons

Howsamplesizewasdetermined

Whenapplicable,explanationofanyinterimanalysesandstoppingguidelines

Methodusedtogeneratetherandomallocationsequence

Typeofrandomisation;detailsofanyrestriction(suchasblockingandblocksize)

Mechanismusedtoimplementtherandomallocationsequence(suchassequentiallynumberedcontainers),describinganystepstakentoconcealthesequenceuntilinterventionswereassigned)

Whogeneratedtheallocationsequence,whoenrolledparticipants,andwhoassignedparticipantstointerventions

Ifdone,whowasblindedafterassignmenttointerventions(forexample,participants,careproviders,thoseassessingoutcomes)andhow

Ifrelevant,descriptionofthesimilarityofinterventions

Statisticalmethodsusedtocomparegroupsforprimaryandsecondaryoutcomes

Methodsforadditionalanalyses,suchassubgroupanalysesandadjustedanalyses

Results

Foreachgroup,thenumbersofparticipantswhowererandomlyassigned,receivedintendedtreatment,andwereanalysedfortheprimaryoutcome

Foreachgroup,lossesandexclusionsafterrandomisation,togetherwithreasons

Datesdefiningtheperiodsofrecruitmentandfollow-up

Whythetrialendedorwasstopped

Atableshowingbaselinedemographicandclinicalcharacteristicsforeachgroup

Foreachgroup,numberofparticipants(denominator)includedineachanalysisandwhethertheanalysiswasbyoriginalassignedgroups

Foreachprimaryandsecondaryoutcome,resultsineachgroup,andtheestimatedeffectsizeanditsprecision(suchas95%confidenceinterval)

Forbinaryoutcomes,presentationofbothabsoluteandrelativeeffectsizesisrecommended

Resultsofanyotheranalysesperformed,includingsubgroupanalysesandadjustedanalyses,distinguishingpre-specifiedfromexploratory

Allimportantharmsorunintendedeffectsineachgroup

Discussion

Triallimitations,addressingsourcesofpotentialbias,imprecision,and,ifrelevant,multiplicityofanalyses

Generalisability(externalvalidity,applicability)ofthetrialfindings

Interpretationconsistentwithresults,balancingbenefitsandharms,andconsideringotherrelevantevidence

OtherInformation

Registrationnumberandnameoftrialregistry

Wherethefulltrialprotocolcanbeaccessed,ifavailable

Sourcesoffundingandothersupport(suchassupplyofdrugs),roleoffunders

ExplanationandElaborationDocument(EE)

OnefeatureoftheoriginalCONSORTStatementin1996(),sharedbyitstwoprecursors()(),wasthenearabsenceofanyexplanationoftheconceptsorjustificationfortheimportanceofspecificinformationbeingneededinreportsofrandomizedtrials.ItwasrecommendedthatthevalueoftheCONSORTStatement,andprobablyalsoitsacceptability,couldbeenhancedbythedevelopmentofasecondpublicationthatclarifiedthescientificbackgroundandexplainedwhyeachissuewasimportant().

ThereforewhentheCONSORTStatementwasrevisedin1999,theopportunitywastakentodevelop,inparalleltotherevisedchecklist,adetailedexplanatorydocument.Theresulting32ExpanationandElaboration(EE)documentwaspublishedsimultaneouslywiththerevisedCONSORTStatementintheAnnalsofInternalMedicinein2001()().Itwasrecognizedasanimportantinnovationandtheideahassubsequentlybeentakenupbyotherreportingguidelinegroups()().

TheEEdocumentaddresseseachchecklistitemindividually.Foreachitem,keymethodologicalissuesareexplainedandasummaryoftheempiricalevidenceabouttheimportanceofreportingthatitemisprovided.Examplesofclearreportingarealsogivenfor