RCT臨床研究遵循CONSORT規(guī)范中文版

1、RCT臨床研究遵循CONSORT規(guī)范（中文版）a®編R項目說明蟲他附例Title and abstract1a題目中說明研究的性質(zhì)，如隨機對照雙盲研究L1b結(jié)構(gòu)式摘要，按期刊要求JIIntroduction (前后部分)2a研究背景、并說明理由2b明確的研究目的與假說uMethods（方法學(xué)部分）Trial design 試驗設(shè)計3a描述試驗設(shè)計（諸如平行、析因）包括人數(shù)分配比例u3bImportant changes to methods after trial commencement (suchas eligibility criteria), with reasons對研究開

2、始后方法上的重要改變進行解釋，比如試驗開始后納入標準的改變1 1Participants 受、_fX，以石4aEligibility criteria for participants受試者的納入、排除和退出標準1o4bSettings and locations where the data were collected數(shù)據(jù)收集的LJ環(huán)境及地點4c倫理學(xué)至上原則Interventions十塊方法5The interventions for each group with sufficient details to allow replication, including how and wh

3、en they were actually administered詳述每組十預(yù)的細節(jié)（以便其它研究者的復(fù)制）及實際實施情況，包括 了實施時間和實施方式Outcomes 結(jié)局指標6aCompletely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 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進行評 價1 ,6bAny changes to trial outcomes after the trial commenced,

4、 with reasons如果在試驗開始后對結(jié)局變量進行修改，必須說明原因LJSample size 樣7aHow sample size was determined如何確定樣本量1本里人小7bWhen applicable, explanation of any interim analyses andstopping guidelines必要時，解釋期中分析及試驗終止原則LJRandomisation:隨機化Sequencegeneration 隨機序列產(chǎn)生的方法8aMethod used to generate the random allocation sequence序列廣生；分配

5、遮蔽；實施匚8bType of randomisation; details of any restriction (such as blockingand block size)隨機化形式，以及描述隨機細節(jié)(如是否后區(qū)組化，有的話，區(qū)組是多少？)LJAllocation concealment mechanism 遮 蔽實施的細節(jié)9Mechanism used to implement the random allocation sequence(such as sequentially numbered containers), describing any steps taken to

6、conceal the sequence until interventions were assigned遮蔽的細節(jié)mplementation隨機實施方法10Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 隨機化序歹妝口何產(chǎn)生，誰招募受試者，誰干預(yù)實施Blinding 盲法11aIf done, who was blinded after assignment to interventions (for

7、 example, participants, care providers, those assessing outcomes) and how若使用了宣法，需指明誰是十預(yù)的被苜者(例如受試者、十預(yù)給予者、結(jié)果評價者）以及如何設(shè)盲11bIf relevant, description of the similarity of interventions如若涉及，描述每組十預(yù)的相似性Statisticalmethods 統(tǒng)計方法12aStatistical methods used to compare groups for primary andsecondary outcomes用于比較組

8、間主要和次要結(jié)局的統(tǒng)計學(xué)方法匚12bMethods for additional analyses, such as subgroup analyses andadjusted analyses附加分析的統(tǒng)計學(xué)方法，比如亞組分析和校正分析11Results結(jié)果部分Participant flow(a diagram isstrongly recommended) 受試者納入流程圖13aFor each group, the numbers of participants who were randomly assigned, received intended treatment, and w

9、ere analysed for the primary outcome報告隨機分配到每一組的受試者，接受治療的例數(shù)以及進行首要結(jié)果分 析的病例數(shù)L13bFor each group, losses and exclusions after randomisation, together with reasons報告進行隨機化后每組的退出和排除情況及原因URecruitment 招募情況14aDates defining the periods of recruitment and follow-up明確招募受試者的時間和隨訪時間14bWhy the trial ended or was st

10、opped說明為何試驗結(jié)束或中止Baseline data基線數(shù)據(jù)15A table showing baseline demographic and clinical characteristics for each group有詳細，規(guī)范的 CRF表記錄患者詳細的基線資料LJNumbersanalysed 試驗人群的數(shù)量16For each group, number of participants (denominator) includedin each analysis and whether the analysis was by originalassigned groups需要

11、明確臨床試驗分析，按ITT人群，還是PP人群，還是全分析集，都需要明確LOutcomes andestimation 結(jié)局17aFor each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)主要終點。對每個主要和次要結(jié)局給出各組的結(jié)果、估計的效應(yīng)大小及 其精度(如95%置信區(qū)間)n17bFor binary outcomes, presentation of both

12、absolute and relativeeffect sizes is recommendedo如果是雙終點，都要分別呈現(xiàn)。Ancillaryanalyses 輔助分析18Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory報告所有其它進行的分析，包括亞組分析和校正分析，說明哪些是預(yù)先 設(shè)定的，哪些是探索性的Harms 不良反應(yīng)19All important harms o

13、r unintended effects in each group (forspecific guidance see CONSORT for harms)所有重要的有害和意料之外的效應(yīng)。詳細記錄AE以及嚴格報告SAEDiscussion討論部分Limitations 局限性20Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses著重潛在偏倚的來源、不精確性和有關(guān)多重分析問題I-Generalisability可適性21G

14、eneralisability (external validity, applicability) of the trialfindings普適性(外部真實性、可應(yīng)用性)1 1Interpretation詮釋結(jié)果22Interpretation consistent with results, balancing benefits andharms, and considering other relevant evidence1解釋與結(jié)果相協(xié)調(diào)，權(quán)衡利和弊，考慮其它證據(jù)Other information其它信息Registration 注冊23Registration number and name of trial registr