RCT临床研究遵循CONSORT规范(汉语版).docxVIP

位置 编号 项目说明 页码 附例 RCT临床研究遵循CONSORT规范（中文版） Title and abstract 1a 题目中说明研究的性质，如随机对照双盲研究 1 ] 1b 结构式摘要，按期刊要求 LJ In troducti on (前言部分) 2a 研究背景、并说明理由 1 2b 明确的研究目的与假说 p Methods （方法学部分） Trial desig n 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 n 3b Importa nt cha nges to methods after trial commencement (such as eligibility criteria), with reas ons 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 i_i Participa nt s受试者 4a Eligibility criteria for participa nts 受试者的纟纳入、排除 和退出标准 n 4b Sett ings and locati ons where the data were  collected数据收集的环境及地点 4c 伦理学至上原则 丨1 In terve ntio ns干预方 法 5 The in terve nti ons for each group with sufficie nt details to allow replicati on, in cludi ng how and whe n they were actually admi nistered 详述每组干预的细节（以便其匕研究者的复制）及头际 实施情况，包括了实施时间和实施方式 丨:i Outcomes 结局指标 6a Completely defi ned pre-specified primary and sec on dary outcome measures, in cludi ng how and whe n 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 cha nges to trial outcomes after the trial comme need, with reas ons 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 determ ined 女口何确定样本量 7b Whe n applicable, expla nati on of any in terim an alyses and stopp ing guideli nes 丨〕  必要时，解释期中分析及试验终止原则 Ran domisa tion:随机 化 Sequenee gen erati on 随机序列产 生的方法 8a Method used to gen erate the ran dom allocatio n sequenee 序列产生；分配遮敝；实施 □ 8b Type of ran domisatio n; details of any restrietio n (such as bloek ing and bloek 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？) 丨I Alloeati on con eealme nt meeha nism 遮敝实施的 细节 9 Meeha nism used to impleme nt the ran dom alloeati on seque nee (sueh as seque ntially nu mbered eon tai ners), deserib ing any steps take n to eon eeal the seque nee un til in terve nti ons were assig ned 遮蔽的细节 L Impleme nt ation随机 10 Who gen erated the ran dom alloeati on seque nee, who en rolled partieipa nts, and who assig ned partieipa nts 丨:  实施方法 to in terve nti ons 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 bli nded after assig nment to interventions (for example, p