RCT临床研究遵循CONSORT规范中文版.doc

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1、RCT临床研究遵循CONSORT规范（中文版）位置编号项目说明页码附例Title and abstract1a题目中说明研究性质，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明确研究目与假说 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

2、重要改变进行解释，比如试验开始后纳入标准改变 Participants 受试者4aEligibility criteria for participants 受试者纳入、排除和退出标准 4bSettings and locations where the data were collected 数据收集环境及地点 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 a

3、ctually administered 详述每组干预细节（以便其它研究者复制）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

4、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 随机序列产生方法8aMethod used to generate the random allocation sequence 序列产生；分配遮蔽；实施 8bType of

5、 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，有话，区组是多少？） Allocation concealment mechanism 遮蔽实施细节9Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequ

6、ence until interventions were assigned 遮蔽细节 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, par

7、ticipants, care providers, those assessing outcomes) and how 若使用了盲法，需指明谁是干预被盲者（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，描述每组干预相似性 Statistical methods 统计方法12aStatistical methods used to compare groups for primary and secondary outcomes 用于比较组间主要和次要结局

8、统计学方法 12bMethods for additional analyses, such as subgroup analyses and adjusted analyses 附加分析统计学方法，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 an

9、alysed for the primary outcome 报告随机分配到每一组受试者，接受治疗例数以及进行首要结果分析病例数 13bFor each group, losses and exclusions after randomisation, together with reasons 报告进行随机化后每组退出和排除情况及原因 Recruitment 招募情况14aDates defining the periods of recruitment and follow-up 明确招募受试者时间和随访时间 14bWhy the trial ended or was stopped 说明

10、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CRF表记录患者详细基线资料 Numbers analysed 试验人群数量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

11、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结果、估计效应大小及其精度（如95%置信区间） 17bFor binary outcomes, presentation of both absolu

12、te 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 报告所有其它进行分析，包括亚组分析和校正分析，说明哪些是预先设定，哪些是探索性 Harms 不良反应19All important harms or uni

13、ntended effects in each group (for specific guidance see CONSORT for harms) 所有重要有害和意料之外效应。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 着重潜在偏倚来源、不精确性和有关多重分析问题 Generalisability 可适性21Gene

14、ralisability (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 注册号和试验注册名需要提供 Protocol 研究方案公开24Where 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