RCT临床研究遵循CONSORT规范中文版

1、RCT临床研究遵循CONSORT规范（中文版）a®编R项目说明虫他附例Title and abstract1a题目中说明研究的性质，如随机对照双盲研究L1b结构式摘要，按期刊要求JIIntroduction (前后部分)2a研究背景、并说明理由2b明确的研究目的与假说uMethods（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u3bImportant changes to methods after trial commencement (suchas eligibility criteria), with reasons对研究开

2、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1 1Participants 受、_fX，以石4aEligibility criteria for participants受试者的纳入、排除和退出标准1o4bSettings and locations where the data were collected数据收集的LJ环境及地点4c伦理学至上原则Interventions十块方法5The interventions for each group with sufficient details to allow replication, including how and wh

3、en they were actually administered详述每组十预的细节（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1 ,6bAny changes to trial outcomes after the trial commenced,

4、 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LJSample size 样7aHow sample size was determined如何确定样本量1本里人小7bWhen applicable, explanation of any interim analyses andstopping guidelines必要时，解释期中分析及试验终止原则LJRandomisation:随机化Sequencegeneration 随机序列产生的方法8aMethod used to generate the random allocation sequence序列广生；分配

5、遮蔽；实施匚8bType of randomisation; details of any restriction (such as blockingand block size)随机化形式，以及描述随机细节(如是否后区组化，有的话，区组是多少？)LJAllocation concealment mechanism 遮 蔽实施的细节9Mechanism used to implement the random allocation sequence(such as sequentially numbered containers), describing any steps taken to

6、conceal the sequence until interventions were assigned遮蔽的细节mplementation随机实施方法10Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 随机化序歹妆口何产生，谁招募受试者，谁干预实施Blinding 盲法11aIf done, who was blinded after assignment to interventions (for

7、 example, participants, care providers, those assessing outcomes) and how若使用了宣法，需指明谁是十预的被苜者(例如受试者、十预给予者、结果评价者）以及如何设盲11bIf relevant, description of the similarity of interventions如若涉及，描述每组十预的相似性Statisticalmethods 统计方法12aStatistical methods used to compare groups for primary andsecondary outcomes用于比较组

8、间主要和次要结局的统计学方法匚12bMethods for additional analyses, such as subgroup analyses andadjusted analyses附加分析的统计学方法，比如亚组分析和校正分析11Results结果部分Participant flow(a diagram isstrongly recommended) 受试者纳入流程图13aFor each group, the numbers of participants who were randomly assigned, received intended treatment, and w

9、ere 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L13bFor 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URecruitment 招募情况14aDates defining the periods of recruitment and follow-up明确招募受试者的时间和随访时间14bWhy the trial ended or was st

10、opped说明为何试验结束或中止Baseline data基线数据15A 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LJNumbersanalysed 试验人群的数量16For each group, number of participants (denominator) includedin each analysis and whether the analysis was by originalassigned groups需要

11、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LOutcomes andestimation 结局17aFor 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)n17bFor binary outcomes, presentation of both

12、absolute and relativeeffect sizes is recommendedo如果是双终点，都要分别呈现。Ancillaryanalyses 辅助分析18Results 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19All important harms o

13、r unintended effects in each group (forspecific 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SAEDiscussion讨论部分Limitations 局限性20Trial 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I-Generalisability可适性21G

14、eneralisability (external validity, applicability) of the trialfindings普适性(外部真实性、可应用性)1 1Interpretation诠释结果22Interpretation consistent with results, balancing benefits andharms, and considering other relevant evidence1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23Registration number and name of trial registr