RCT臨床研究遵循CONSORT規(guī)范漢語(yǔ)版

1、編號(hào)項(xiàng)目說(shuō)明貞他附例RCT臨床研究遵循CONSORT規(guī)范（中文版）Titleandabstract1a題目中說(shuō)明研究的性質(zhì)，如隨機(jī)對(duì)照雙盲研究f11b結(jié)構(gòu)式摘要，按期刊要求'1Introduction(前言部分)2a研究背景、并說(shuō)明理由2b明確的研究目的與假說(shuō)Methods（方法學(xué)部分）Trialdesign試驗(yàn)設(shè)計(jì)3a描述試驗(yàn)設(shè)計(jì)（諸如平行、析因）包括人數(shù)分配比例n3bImportantchangestomethodsaftertrialcommencement(suchaseligibilitycriteria),withreasons對(duì)研究升始后方法上的重要改變進(jìn)行解釋，比如試驗(yàn)

2、開始后納入標(biāo)準(zhǔn)的改變Participants受試者4aEligibilitycriteriaforparticipants受試者的納入、排除和退出標(biāo)準(zhǔn)n4bSettingsandlocationswherethedatawere百collected數(shù)據(jù)收集的環(huán)境及地點(diǎn)4c倫理學(xué)至上原則nInterventions干預(yù)力法5Theinterventionsforeachgroupwithsufficientdetailstoallowreplication,includinghowandwhentheywereactuallyadministered羊述每組干預(yù)的細(xì)節(jié)（以便其它研究者的復(fù)制）及實(shí)

3、際實(shí)施情況，包括了實(shí)施時(shí)間和實(shí)施方式Outcomes結(jié)局指標(biāo)6aCompletelydefinedpre-specifiedprimaryandsecondaryoutcomemeasures,includinghowandwhentheywereassessed明確定義預(yù)先指定的首要和次要結(jié)局變量，包括了解如何和何時(shí)進(jìn)行評(píng)價(jià)6bAnychangestotrialoutcomesafterthetrialcommenced,withreasons如果在試驗(yàn)開始后對(duì)結(jié)局變量進(jìn)行修改，必須說(shuō)明原因nSamplesize樣本量大小7aHowsamplesizewasdetermined如何確定樣本量

4、17bWhenapplicable,explanationofanyinterimanalysesandstoppingguidelinesn必要時(shí)，解釋期中分析及試驗(yàn)終止原則Randomisation:隨機(jī)化Sequencegeneration隨機(jī)序列產(chǎn)生的方法8aMethodusedtogeneratetherandomallocationsequence仔列產(chǎn)生；分配遮蔽；實(shí)施8bTypeofrandomisation;detailsofanyrestriction(suchasblockingandblocksize)隨機(jī)化形式，以及描述隨機(jī)細(xì)節(jié)(如是否有區(qū)組化，有的話，區(qū)組是多少？)

5、口Allocationconcealmentmechanism遮蔽實(shí)施的細(xì)節(jié)9Mechanismusedtoimplementtherandomallocationsequence(suchassequentiallynumberedcontainers),describinganystepstakentoconcealthesequenceuntilinterventionswereassigned遮蔽的細(xì)節(jié)cImplementation隨機(jī)10Whogeneratedtherandomallocationsequence,whoenrolledparticipants,andwhoassi

6、gnedparticipants實(shí)施方法tointerventions隨機(jī)化序列如何產(chǎn)生，誰(shuí)招募受試者，誰(shuí)干預(yù)實(shí)施Blinding盲法11aIfdone,whowasblindedafterassignmenttointerventions(forexample,participants,careproviders,thoseassessingoutcomes)andhow若使用了盲法，需指明誰(shuí)是干預(yù)的被盲者(例如受試者、ra給予者、結(jié)果評(píng)價(jià)者)以及如何設(shè)盲匚11bIfrelevant,descriptionofthesimilarityofinterventions如若涉及，描述每組ra的相

7、似性PStatisticalmethods統(tǒng)計(jì)方法12aStatisticalmethodsusedtocomparegroupsforprimaryandsecondaryoutcomes用于比較組間主要和次要結(jié)局的統(tǒng)計(jì)學(xué)方法P12bMethodsforadditionalanalyses,suchassubgroupanalysesandadjustedanalyses附加分析的統(tǒng)計(jì)學(xué)方法，比如亞組分析和校正分析Results結(jié)果部分Participantflow(a13aForeachgroup,thenumbersofparticipantswhowererandomlyassigne

8、d,receivedintendedtreatment,and11diagramisstronglyrecommended)受試者納入流程圖wereanalysedfortheprimaryoutcome報(bào)告隨機(jī)分配到每一組的受試者，接受治療的例數(shù)以及進(jìn)行首要結(jié)果分析的病例數(shù)13bForeachgroup,lossesandexclusionsafterrandomisation,togetherwithreasonsse告進(jìn)行隨機(jī)化后每組的退出和排除情況及原因Recruitment招募情況14aDatesdefiningtheperiodsofrecruitmentandfollow-up明

9、確招募受試者的時(shí)間和隨訪時(shí)間14bWhythetrialendedorwasstopped說(shuō)明為何試驗(yàn)結(jié)束或中止OBaselinedata基線數(shù)據(jù)15Atableshowingbaselinedemographicandclinicalcharacteristicsforeachgroup有詳細(xì)，規(guī)范的CRF表記錄患者詳細(xì)的基線資料Numbersanalysed試驗(yàn)人群的數(shù)量16Foreachgroup,numberofparticipants(denominator)includedineachanalysisandwhethertheanalysiswasbyoriginalassigne

10、dgroups需要明確臨床試驗(yàn)分析，按ITT人群，還是PP人群，還是全分析集，都需要明確nOutcomesandestimation結(jié)局17aForeachprimaryandsecondaryoutcome,resultsforeachgroup,andtheestimatedeffectsizeanditsprecision(suchas95%confidenceinterval)主要終點(diǎn)。對(duì)每個(gè)主要和次要結(jié)局給出各組的結(jié)果、估計(jì)的效應(yīng)大小及其精度(如95%置信區(qū)間)17bForbinaryoutcomes,presentationofbothabsoluteandrelativeeffe

11、ctsizesisrecommended如果是雙終點(diǎn)，都要分別呈現(xiàn)。Ancillaryanalyses輔助分析18Resultsofanyotheranalysesperformed,includingsubgroupanalysesandadjustedanalyses,distinguishingpre-specifiedfromexploratory“告所有具它進(jìn)行的分析，包括亞組分析和校正分析，說(shuō)明哪些是預(yù)先設(shè)定的，哪些是探索性的LJHarms不良反應(yīng)19Allimportantharmsorunintendedeffectsineachgroup(forspecificguidanc

12、eseeCONSORTforharms)所有重要的有害和意料之外的效應(yīng)。詳細(xì)記錄AE以及嚴(yán)格報(bào)SAELJDiscussion討論部分Limitations局限性20Triallimitations,addressingsourcesofpotentialbias,imprecision,and,ifrelevant,multiplicityofanalyses著重潛在偏倚的來(lái)源、不精確性和有關(guān)多重分析問(wèn)題Generalisability可適性21Generalisability(externalvalidity,applicability)ofthetrialfindings普適性(外部真實(shí)性、可應(yīng)用性)Interpretation詮釋結(jié)果22Interpretationconsistentwithresults,balancingbenefitsandharms,andconsideringotherrelevantevidence解釋與結(jié)果相協(xié)調(diào)，權(quán)衡利和弊，考慮具它證據(jù)Otherinformation其它信息Registration注冊(cè)23Registrationnumberandnameoftrialregistr