RCT临床研究遵循CONSORT规范[中文版].docVIP

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  HTMLCONTROL Forms.HTML:Text.1 ?1b结构式摘要，按期刊要求  HTMLCONTROL Forms.HTML:Text.1 ?Introduction（前言部分）?2a研究背景、并说明理由  HTMLCONTROL Forms.HTML:Text.1 ?2b明确的研究目的与假说  HTMLCONTROL Forms.HTML:Text.1 ?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  HTMLCONTROL Forms.HTML:Text.1 ?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  HTMLCONTROL Forms.HTML:Text.1 ?Participants 受试者4aEligibility criteria for participants? 受试者的纳入、排除和退出标准  HTMLCONTROL Forms.HTML:Text.1 ?4bSettings and locations where the data were collected? 数据收集的环境及地点  HTMLCONTROL Forms.HTML:Text.1 ??4c伦理学至上原则  HTMLCONTROL Forms.HTML:Text.1 ?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  HTMLCONTROL Forms.HTML:Text.1 ?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  HTMLCONTROL Forms.HTML:Text.1 ?6bAny changes to trial outcomes after the trial commenced, with reasons 如果在试验开始后对结???变量进行修改，必须说明原因  HTMLCONTROL Forms.HTML:Text.1 ?Sample size 样本量大小7aHow sample size was determined 如何确定样本量  HTMLCONTROL Forms.HTML:Text.1 ?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  HTMLCONTROL Forms.HTML:Text.1 ?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  HTMLCONTROL Forms.HTML:Text.1 ?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？）  HTMLCONTROL Forms.HT