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RCT临床研究遵循CONSORT规范(汉语版).doc

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RCT临床研究遵循CONSORT规范(汉语版).doc
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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)3a 描述试验设计 (诸如平行、析因) 包括人数分配比例 Trial design 试验设计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 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 Outcomes 结局指标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7a How sample size was determined 如何确定样本量 量大小 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8a Method used to generate the random allocation sequence 序列产生;分配遮蔽;实施 Sequence generation 随机序列产生的方法 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 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 若使用了盲法,需指明谁是干预的被盲者(例如受试者、干预给予者、结果评价者)以及如何设盲 Blinding 盲法11b If relevant, description of the similarity of
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