RCT临床研究遵循CONSORT规范汉语版

1、RCT临床研究遵循 CONSOR规T 范 （汉语版）位置编号项目说明页码附例RCT 临床研究遵循 CONSORT 规范（中文版）Title and abstract1a题目中说明研究的性质，如随机对照双盲研究1b结构式摘要，按期刊要求Introduction （前言部分）2a研究背景、并说明理由2b明确的研究目的与假说Methods （方法学部分）Trial design 试 验设计3a描述试验设计 （诸如平行、析因 ） 包括人数分配比例3bImportant changes to methods after trial commencement (such as eligibility cr

2、iteria), with reasons 对研究开始后方法上的重要改变进行解释， 比如试验开 始后纳入标准的改变Participant s 受试者4aEligibility criteria for participants受试者的纳入、排除和退出标准4bSettings and locations where the data werecollected 数据收集的环境及地点4c伦理学至上原则Interventio ns 干预方 法5The interventions for each group with sufficientdetails to allow replication, i

3、ncluding how and when they were actually administered 详述每组干预的细节 （以便其它研究者的复制） 及实际 实施情况，包括了实施时间和实施方式Outcomes结局指标6aCompletely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 明确定义预先指定的首要和次要结局变量， 包括了解如 何和何时进行评价6bAny changes to trial outcomes after t

4、he trial commenced, with reasons 如果在试验开始后对结局变量进行修改， 必须说明原因Sample size 样本 量大小7aHow sample size was determined 如何确定样本量7bWhen applicable, explanation of any interim analyses and stopping guidelines必要时，解释期中分析及试验终止原则Randomis ation: 随 机化Sequence generation 随机序列产 生的方法8aMethod used to generate the random al

5、location sequence 序列产生；分配遮蔽；实施8bType of randomisation; details of any restriction (such as blocking and block size) 随机化形式，以及描述随机细节(如是否有区组化，有 的话，区组是多少？)Allocation concealme nt mechanis m 遮蔽实 施的细节9Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), de

6、scribing any steps taken to conceal the sequence until interventions were assigned 遮蔽的细节Implementation随机实施方法10Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 随机化序列如何产生，谁招募受试者，谁干预实施UBlinding盲法11aIf done, who was blinded after ass

7、ignment to interventions (for example, participants, care providers, those assessing outcomes) and how 若使用了盲法，需指明谁是干预的被盲者(例如受试者、 干预给予者、结果评价者)以及如何设盲U11bIf relevant, description of the similarity of in terventions如若涉及，描述每组干预的相似性LJStatistical methods 统计方法12aStatistical methods used to compare groups fo

8、r primary and secondary outcomes 用于比较组间主要和次要结局的统计学方法U12bMethods for additional analyses, such as subgroup analyses and adjusted analyses 附加分析的统计学方法，比如亚组分析和校正分析UResults结果部分Participant flow (a diagram is strongly recommen ded)受试 者纳入流程 图13aFor each group, the numbers of participants who were randomly a

9、ssigned, received intended treatment, and were analysed for the primary outcome报告随机分配到每一组的受试者，接受治疗的例数以及 进行首要结果分析的病例数u13bFor each group, losses and exclusions after randomisation, together with reasons 报告进行随机化后每组的退出和排除情况及原因uRecruitment招募情况14aDates defining the periods of recruitment and follow-up明确招募

10、受试者的时间和随访时间u14bWhy the trial ended or was stopped说明为何试验结束或中止uBaseline data基线数据15A table showing baseline demographic and clinical characteristics for each group 有详细，规范的CRF表记录患者详细的基线资料uNumbers analysed16For each group, number of participants(denominator) included in each analysis andu10Who generated

11、the random allocation sequence, who enrolled participants, and who assigned participants to interventions 随机化序列如何产生，谁招募受试者，谁干预实施11aIf done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 若使用了盲法，需指明谁是干预的被盲者 (例如受试者、 干预给予者

12、、结果评价者)以及如何设盲11bIf relevant, description of the similarity of interventions 如若涉及，描述每组干预的相似性12aStatistical methods used to compare groups for primary and secondary outcomes 用于比较组间主要和次要结局的统计学方法12bMethods for additional analyses, such as subgroup analyses and adjusted analyses 附加分析的统计学方法，比如亚组分析和校正分析13a

13、For each group, the numbers of participants whowere randomly assigned, received intendedtreatment, and were analysed for the primary outcome 报告随机分配到每一组的受试者， 接受治疗的例数以及 进行首要结果分析的病例数13bFor each group, losses and exclusions after randomisation, together with reasons 报告进行随机化后每组的退出和排除情况及原因14aDates definin

14、g the periods of recruitment and follow-up 明确招募受试者的时间和随访时间14bWhy the trial ended or was stopped 说明为何试验结束或中止15A table showing baseline demographic and clinical characteristics for each group 有详细，规范的 CRF 表记录患者详细的基线资料16For each group, number of participants (denominator) included in each analysis andwh

15、ether the analysis was by original assigned groups 需要明确临床试验分析，按 ITT 人群，还是 PP 人群， 还是全分析集，都需要明确Outcomes andestimation 结局17aFor each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 主要终点。 对每个主要和次要结局给出各组的结果、 估 计的效应大小

16、及其精度(如 95% 置信区间)17bFor binary outcomes, presentation of both absolute and relative effect sizes is recommended 如果是双终点，都要分别呈现。Ancillary analyses 辅助分析18Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 报告所有其它进行的分析，

17、包括亚组分析和校正分析， 说明哪些是预先设定的，哪些是探索性的Harms 不19All important harms or unintended effects in each group (for specific guidance see CONSORT for良反应harms) 所有重要的有害和意料之外的效应。 详细记录 AE 以及 严格报告 SAEDiscussion 讨论部分Limitation s 局限性20Trial limitations, addressing sources of potential bias, imprecision, and, if relevant,

18、 multiplicity of analyses 着重潜在偏倚的来源、不精确性和有关多重分析问题Generalisa bility 可适 性21Generalisability (external validity, applicability) of the trial findings 普适性 (外部真实性、可应用性 )Interpretat ion 诠释结 果22Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 解释与结果相协调，权衡利和弊，考虑其它证据Other information 其它信息Regi