RCT临床研究遵循CONSORT规范（中文版）
RCT临床研究遵循CONSORT规范（中文版）2013-5-4 作者：MedSci 来源：MedSci 我要评论18http://www.medsci.cn/images/hot.jpg Tags:CONSORT临床研究
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CONSORT 2010 checklist for (title)
位置
编号
项目说明
页码
附例
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
3bImportant 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
4aEligibility criteria for participants受试者的纳入、排除和退出标准
4bSettings 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
5The 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
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 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
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
Randomisation: 随机化
Sequence generation 随机序列产生的方法
8aMethod used to generate the random allocation 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 concealment mechanism 遮蔽实施的细节
9Mechanism 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
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
Blinding 盲法
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、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
Statistical methods 统计方法
12aStatisticalmethods 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
Results 结果部分
Participant flow (a diagram is strongly recommended) 受试者纳入流程图
13aFor 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
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
Recruitment 招募情况
14aDates defining 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
Baseline 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
Numbers analysed 试验人群的数量
16For 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
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，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
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应。详细记录AE以及严格报告SAE
Discussion 讨论部分
Limitations 局限性
20Trial 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
21Generalisability (external validity, applicability) of the trial findings
普适性 (外部真实性、可应用性)
Interpretation 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
Registration 注册
23Registration 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
24Wherethe full trial protocol can be accessed, if available
研究方案在哪里可以读到
Funding 资金资助
25Sources 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
附: 2010新版consort声明简介 谢谢分享:) 谢谢裴老师和付老师的分享！
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