RCT临床研究遵循CONSORT规范VIP专享

RCT 临床讨论遵循 CONSORT 法律规范（中文版）位置编号项目说明页码附例Title and abstract 1a题目中说明讨论的性质，如随机对比双盲讨论 1b结构式摘要,按期刊要求 Introduction（前言部分） 2a讨论背景、并说明理由 2b明确的讨论目的与假说 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 对讨论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（以便其它讨论者的复制）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 假如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 9Mechanism used to implement the random allocation sequence （such as sequentially numbered contai...