RCT临床研究遵循CONSORT规范(中文版).doc

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 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 provide