完整版RCT临床研究遵循CONSORT规范中文版VIP专享VIP免费

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 numb...