RCT临床研究遵循CONSORT规范（中文版）

Title and abstract

1a

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

3b

Important changes to methods after trial commencement (such as eligibility criteria), 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

Participants 受试者

4a

Eligibility criteria for participants 受试者的纳入、排除和退出标准

4b

Settings and locations where the data were collected 数据收集的环境及地点

4c

伦理学至上原则

Interventions 干预方法

5

The interventions for each group with sufficient details to allow replication, including 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

6a

Completely 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

6b

Any changes to trial outcomes after the 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

7a

How sample size was determined 如何确定样本量

7b

When 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

Randomisation: 随机化

 Sequence generation 随机序列产生的方法

8a

Method used to generate the random allocation sequence
序列产生；分配遮蔽；实施

8b

Type 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 concealment mechanism 遮蔽实施的细节

9

Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
遮蔽的细节

 Implementation 随机实施方法

10

Who 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

Blinding 盲法

11a

If 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、结果评价者）以及如何设盲

11b

If relevant, description of the similarity of interventions
如若涉及，描述每组干预的相似性

Statistical methods 统计方法

12a

Statistical 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

12b

Methods 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

Results 结果部分

Participant flow (a diagram is strongly recommended) 受试者纳入流程图

13a

For each group, the numbers of participants who were randomly assigned, 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

13b

For 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

Recruitment 招募情况

14a

Dates defining the periods of recruitment and follow-up
明确招募受试者的时间和随访时间

14b

Why the trial ended or was stopped
说明为何试验结束或中止

Baseline data 基线数据

15

A 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

Numbers analysed 试验人群的数量

16

For each group, number of participants (denominator) included in each analysis and whether 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 and estimation 结局

17a

For 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、估计的效应大小及其精度（如95%置信区间）

17b

For 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

18

Results 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，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 不良反应

19

All 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应。详细记录AE以及严格报告SAE

Discussion 讨论部分

Limitations 局限性

20

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, 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

Generalisability 可适性

21

Generalisability (external validity, applicability) of the trial findings
普适性 (外部真实性、可应用性)

Interpretation 诠释结果

22

Interpretation 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

Registration 注册

23

Registration number and name of trial registry
注册号和试验的注册名需要提供

Protocol 研究方案公开

24

Where the full trial protocol can be accessed, if available
研究方案在哪里可以读到

Funding 资金资助

25

Sources of funding and other support (such as supply of drugs), role of funders
基金来源和其他支持(如提供药品) , 资助者所起作用