RCT臨床研究遵循CONSORT規(guī)范(漢語版)

1、RCT臨床研究遵循CONSORT規(guī)范（中文版）位置編號(hào)項(xiàng)目說明頁碼附例Title and abstract1a題目中說明研究的性質(zhì)，如隨機(jī)對(duì)照雙盲研究 1b結(jié)構(gòu)式摘要，按期刊要求 Introduction（前言部分）2a研究背景、并說明理由 2b明確的研究目的與假說 Methods（方法學(xué)部分）Trial design 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 3bImportant changes to methods after trial commencement (such as eligibility criteria), with reasons 對(duì)研究開始后

2、方法上的重要改變進(jìn)行解釋，比如試驗(yàn)開始后納入標(biāo)準(zhǔn)的改變 Participants 受試者4aEligibility criteria for participants 受試者的納入、排除和退出標(biāo)準(zhǔn) 4bSettings and locations where the data were collected 數(shù)據(jù)收集的環(huán)境及地點(diǎn) 4c倫理學(xué)至上原則 Interventions 干預(yù)方法5The interventions for each group with sufficient details to allow replication, including how and when they

3、 were actually administered 詳述每組干預(yù)的細(xì)節(jié)（以便其它研究者的復(fù)制）及實(shí)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)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(shí)進(jìn)行評(píng)價(jià) 6bAny changes to trial outcomes after the trial commenced, with rea

4、sons 如果在試驗(yàn)開始后對(duì)結(jié)局變量進(jìn)行修改，必須說明原因 Sample size 樣本量大小7aHow sample size was determined 如何確定樣本量 7bWhen applicable, explanation of any interim analyses and stopping guidelines 必要時(shí)，解釋期中分析及試驗(yàn)終止原則 Randomisation: 隨機(jī)化Sequence generation 隨機(jī)序列產(chǎn)生的方法8aMethod used to generate the random allocation sequence 序列產(chǎn)生；分配遮蔽；實(shí)

5、施 8bType of randomisation; details of any restriction (such as blocking and block size) 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？） Allocation concealment mechanism 遮蔽實(shí)施的細(xì)節(jié)9Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to con

6、ceal the sequence until interventions were assigned 遮蔽的細(xì)節(jié) Implementation 隨機(jī)實(shí)施方法10Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 隨機(jī)化序列如何產(chǎn)生，誰招募受試者，誰干預(yù)實(shí)施 Blinding 盲法11aIf done, who was blinded after assignment to interventions (fo

7、r example, participants, care providers, those assessing outcomes) and how 若使用了盲法，需指明誰是干預(yù)的被盲者（例如受試者、干預(yù)給予者、結(jié)果評(píng)價(jià)者）以及如何設(shè)盲 11bIf relevant, description of the similarity of interventions 如若涉及，描述每組干預(yù)的相似性 Statistical methods 統(tǒng)計(jì)方法12aStatistical methods used to compare groups for primary and secondary outcom

8、es 用于比較組間主要和次要結(jié)局的統(tǒng)計(jì)學(xué)方法 12bMethods for additional analyses, such as subgroup analyses and adjusted analyses 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Participant flow (a diagram is strongly recommended) 受試者納入流程圖13aFor each group, the numbers of participants who were randomly assigned, received intended trea

9、tment, and were analysed for the primary outcome 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) 13bFor each group, losses and exclusions after randomisation, together with reasons 報(bào)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14aDates defining the periods of recruitment and follow-up 明確招募受試者的時(shí)間和隨訪時(shí)間 14bWhy the trial

10、ended or was stopped 說明為何試驗(yàn)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(xì)，規(guī)范的CRF表記錄患者詳細(xì)的基線資料 Numbers analysed 試驗(yàn)人群的數(shù)量16For each group, number of participants (denominator) included in each analysis and whether the analysis was by origin

11、al assigned groups 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 Outcomes and estimation 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(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） 17bFor binary outcomes,

12、 presentation of both absolute and relative effect sizes is recommended 如果是雙終點(diǎn)，都要分別呈現(xiàn)。 Ancillary analyses 輔助分析18Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 報(bào)告所有其它進(jìn)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

13、良反應(yīng)19All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) 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)告SAE Discussion 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

14、關(guān)多重分析問題 Generalisability 可適性21Generalisability (external validity, applicability) of the trial findings 普適性 (外部真實(shí)性、可應(yīng)用性) Interpretation 詮釋結(jié)果22Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 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(cè)23Registration number and name of trial registry