CONSORT2010说明与详述_报告平行对照随机临床试验指南的更新

Correspondence:DavidMoher,PhD;Email:[e-mail]ONSORT2010:DavidMoher1,SallyHopewell2,KennethFSchulz3,VictorMontori4,PeterCGtzsche5,PJDevereaux6,DianaElbourne7,MatthiasEgger8,DouglasGAltman21.OttawaMethodsCentre,ClinicalEpidemiologyProgram,OttawaHospitalResearchInstitute,OttawaHospital,Ottawa,Ontario,Canada,K1H8L62.CentreforStatisticsinMedicine,UniversityofOxford,WolfsonCollege,Oxford,UK3.FamilyHealthInternational,ResearchTrianglePark,NC27709,USA4.UKKnowledgeandEncounterResearchUnit,MayoClinic,Rochester,MN,USA5.TheNordicCochraneCentre,Rigshospitalet,Blegdamsvej9,Copenhagen,Denmark6.McMasterUniversityHealthSciencesCentre,Hamilton,Canada7.MedicalStatisticsUnit,LondonSchoolofHygieneandTropicalMedicine,London,UK8.InstituteofSocialandPreventiveMedicine(ISPM),UniversityofBern,Switzerland:大量证据显示随机对照临床试验(randomisedcontrolledtrial,RCT)的报告质量不理想报告不透明,则读者既不能评判试验结果是否真实可靠,也不能从中提取可用于系统综述的信息最近的方法学分析表明,报告不充分和设计不合理与对治疗效果产生评价偏倚有关这种系统误差对RCT损害严重,而RCT正是以其能减少或避免偏倚而被视为评价干预措施的金标准为了提高RCT的报告质量,一个由专家和编辑组成的工作组制定了临床试验报告的统一标准(ConsolidatedStandardsofReportingTrials,CONSORT)声明CONSORT声明于1996年首次发表,并于2001年更新声明由对照检查清单和流程图组成,供作者在报告RCT时使用许多核心医学期刊和主要国际性编辑组织都已认可CONSORT声明该声明促进了对RCT的严格评价和解释2001年,在对CONSORT进行修订时,人们就已经清楚地认识到,解释和说明制定CONSORT声明的原理,有助于研究人员等撰写或评价临床试验报告一篇CONSORT说明与详述文章于2001年同2001版CONSORT声明一起发表2007年1月的专家会议之后,对CONSORT声明作了进一步修订并已发表,即CONSORT2010声明这次更新对原版对照检查清单作了文字上的修改,使其更为明晰,并收入了与一些新近才认识到的主题相关的建议,如选择性报告结局产生的偏倚说明与详述文件旨在加强人们对CONSORT声明的理解应用和传播,这次也作了大量修订,对每一项新增或更新的清单条目的含义和增改理由进行了解释,提供了优秀的报告实例,还尽可能地提供了相关的经验性研究的参考文献文中收入了若干流程图实例CONSORT2010声明其说明与详述文件,以及相关网站(),对于改进随机临床试验报告必将有所裨益:临床试验;随机对照试验;指南;CONSORTMoherD,HopewellS,SchulzKF,MontoriV,GtzschePC,DevereauxPJ,ElbourneD,EggerM,AltmanDG.JChinIntegrMed.2010;8(8):701741.ReceivedJuly21,2010;acceptedJuly29,2010;publishedonlineAugust15,2010.Indexed/abstractedinandfulltextlinkoutatPubMed.JournaltitleinPubMed:ZhongXiYiJieHeXueBao.Freefulltext(HTMLandPDF)isavailableat!701!2010888JournalofChineseIntegrativeMedicine,August2010,Vol.8,No.8CONSORT2010ExplanationandElaboration:updatedguidelinesforreportingparallelgrouprandomisedtrials(Chineseversion)DavidMoher1,SallyHopewell2,KennethFSchulz3,VictorMontori4,PeterCGtzsche5,PJDevereaux6,DianaElbourne7,MatthiasEgger8,DouglasGAltman21.OttawaMethodsCentre,ClinicalEpidemiologyProgram,OttawaHospitalResearchInstitute,OttawaHospital,Ottawa,Ontario,Canada,K1H8L62.CentreforStatisticsinMedicine,UniversityofOxford,WolfsonCollege,Oxford,UK3.FamilyHealthInternational,ResearchTrianglePark,NC27709,USA4.UKKnowledgeandEncounterResearchUnit,MayoClinic,Rochester,MN,USA5.TheNordicCochraneCentre,Rigshospitalet,Blegdamsvej9,Copenhagen,Denmark6.McMasterUniversityHealthSciencesCentre,Hamilton,Canada7.MedicalStatisticsUnit,LondonSchoolofHygieneandTropicalMedicine,London,UK8.InstituteofSocialandPreventiveMedicine(ISPM),UniversityofBern,SwitzerlandAbstract:Overwhelmingevidenceshowsthequalityofreportingofrandomisedcontrolledtrials(RCTs)isnotoptimal.Withouttransparentreporting,readerscannotjudgethereliabilityandvalidityoftrialfindingsnorextractinformationforsystematicreviews.Recentmethodologicalanalysesindicatethatinadequatereportinganddesignareassociatedwithbiasedestimatesoftreatmenteffects.SuchsystematicerrorisseriouslydamagingtoRCTs,whichareconsideredthegoldstandardforevaluatinginterventionsbecauseoftheirabilitytominimiseoravoidbias.AgroupofscientistsandeditorsdevelopedtheCONSORT(ConsolidatedStandardsofReportingTrials)statementtoimprovethequalityofreportingofRCTs.Itwasfirstpublishedin1996andupdatedin2001.ThestatementconsistsofachecklistandflowdiagramthatauthorscanuseforreportinganRCT.ManyleadingmedicaljournalsandmajorinternationaleditorialgroupshaveendorsedtheCONSORTstatement.ThestatementfacilitatescriticalappraisalandinterpretationofRCTs.Duringthe2001CONSORTrevision,itbecameclearthatexplanationandelaborationoftheprinciplesunderlyingtheCONSORTstatementwouldhelpinvestigatorsandotherstowriteorappraisetrialreports.ACONSORTexplanationandelaborationarticlewaspublishedin2001alongsidethe2001versionoftheCONSORTstatement.AfteranexpertmeetinginJanuary2007,theCONSORTstatementhasbeenfurtherrevisedandispublishedastheCONSORT2010Statement.Thisupdateimprovesthewordingandclarityofthepreviouschecklistandincorporatesrecommendationsrelatedtotopicsthathaveonlyrecentlyreceivedrecognition,suchasselectiveoutcomereportingbias.Thisexplanatoryandelaborationdocument∀intendedtoenhancetheuse,understanding,anddisseminationoftheCONSORTstatement∀hasalsobeenextensivelyrevised.Itpresentsthemeaningandrationaleforeachnewandupdatedchecklistitemprovidingexamplesofgoodreportingand,wherepossible,referencestorelevantempiricalstudies.Severalexamplesofflowdiagramsareincluded.TheCONSORT2010Statement,thisrevisedexplanatoryandelaborationdocument,andtheassociatedwebsite()shouldbehelpfulresourcestoimprovereportingofrandomisedtrials.Keywords:clinicaltrials;randomizedcontrolle