RCT临床研究遵循CONSORT规范（中文版）

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RCT临床研究遵循CONSORT规范（中文版）2013-5-4                                 作者：MedSci   来源：MedSci                                 我要评论18                               
                                 Tags:  CONSORT  临床研究                                   
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CONSORT 2010 checklist for       (title)

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    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
Blinding 盲法	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
	11b	If relevant, description of the similarity of interventions 如若涉及，描述每组干预的相似性
Statistical    methods 统计方法	12a	Statistical  methods used to compare groups for primary and secondary outcomes 用于比较组间主要和次要结局的统计学方法
	12b	Methods    for additional analyses, such as subgroup analyses and adjusted analyses 附加分析的统计学方法，比如亚组分析和校正分析
Results 结果部分
Participant    flow (a diagram is strongly recommended) 受试者纳入流程图	13a	For each group, the numbers of participants who were randomly assigned, received    intended treatment, and were analysed for the primary outcome 报告随机分配到每一组的受试者，接受治疗的例数以及进行首要结果分析的病例数
	13b	For    each group, losses and exclusions after randomisation, together with reasons 报告进行随机化后每组的退出和排除情况及原因
Recruitment 招募情况	14a	Dates defining the periods of recruitment and follow-up 明确招募受试者的时间和随访时间
	14b	Why the trial ended or was stopped 说明为何试验结束或中止
Baseline data 基线数据	15	A table showing baseline demographic and clinical characteristics for each    group 有详细，规范的CRF表记录患者详细的基线资料
Numbers analysed 试验人群的数量	16	For each group, number of participants (denominator) included in each analysis    and whether the analysis was by original assigned groups 需要明确临床试验分析，按ITT人群，还是PP人群，还是全分析集，都需要明确
Outcomes    and estimation 结局	17a	For each primary and secondary outcome, results for each group, and the estimated    effect size and its precision (such as 95% confidence interval) 主要终点。对每个主要和次要结局给出各组的结果、估计的效应大小及其精度（如95%置信区间）
	17b	For binary outcomes, presentation of both absolute    and relative effect sizes is recommended 如果是双终点，都要分别呈现。
Ancillary    analyses 辅助分析	18	Results    of any other analyses performed, including subgroup analyses and adjusted    analyses, distinguishing pre-specified from exploratory 报告所有其它进行的分析，包括亚组分析和校正分析，说明哪些是预先设定的，哪些是探索性的
Harms 不良反应	19	All    important harms or unintended effects in each group (for specific    guidance see CONSORT for harms) 所有重要的有害和意料之外的效应。详细记录AE以及严格报告SAE
Discussion 讨论部分
Limitations 局限性	20	Trial    limitations, addressing sources of potential bias, imprecision, and, if    relevant, multiplicity of analyses 着重潜在偏倚的来源、不精确性和有关多重分析问题
Generalisability 可适性	21	Generalisability (external validity, applicability) of the trial findings 普适性 (外部真实性、可应用性)
Interpretation 诠释结果	22	Interpretation    consistent with results, balancing benefits and harms, and considering other    relevant evidence 解释与结果相协调，权衡利和弊，考虑其它证据
Other information 其它信息
Registration 注册	23	Registration    number and name of trial registry 注册号和试验的注册名需要提供
Protocol 研究方案公开	24	Where  the full trial protocol can be accessed, if available 研究方案在哪里可以读到
Funding 资金资助	25	Sources    of funding and other support (such as supply of drugs), role of funders 基金来源和其他支持(如提供药品) , 资助者所起作用

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附: 2010新版consort声明简介

颜铭航

谢谢分享

slj790425

谢谢裴老师和付老师的分享！