要想理解随机对照试验（RCT）的结果，读者必须了解其设计、实施、分析和解释。这种目标只能通过作者的完全透明而实现。尽管做了几十年的教育努力，RCTs的报告方法仍然需要改进。调查人员和编辑们为了帮助作者提高报告的质量，通过使用核对表和流程图的形式开发了原CONSORT（报告试验的强化标准）。

核对表的项目涵盖了文题、摘要、引言、方法、结果和讨论部分的内容。修订的核对表包括精选的22个项目，经验证据表明不报告这些信息会对疗效产生错误估计，或者需要这些信息以判断发现的可靠性和相关性。流程图描述了受试者参与RCT的经过。修订的流程图描述了试验的4个阶段（登记，干预分配，随访和分析）的信息。流程图清楚地显示了每个干预组的受试者数量，包含在资料的初步分析中。包含这些数字，便于读者判断作者是否采用了有意处理（intention-to-treat）分析法。

报告随机试验所含的项目核对表

论文部分和主题	项目编号	应描述的内容
文题和摘要	1	受试者是如何分配干预的（如“随机分配”，“随机”或“随机指派”）
引言     背景	2	科学背景和原理的解释
方法     受试者	3	受试者的适合标准，以及资料收集的环境和地点
干预	4	各组干预措施的准确资料，以及实际实施的方法和时间
目的	5	特定的目的和假设
结局	6	明确定义主要和次要结果的测量方法，如果可行的话，说明用于提高测量质量的方法（如多重观察，评估人员的培训等）
样本量	7	样本量是如何确定的，如果可行的话，解释任何期间分析和终止试验的准则
随机化     顺序产生	8	用于产生随机分配顺序的方法，包括任何限制的细节（如分层）
随机化        分配隐蔽	9	用于实施随机分配顺序的方法（如编号的容器或中心电话），说明分配干预前顺序是否是隐蔽的
随机化 实施	10	谁产生的分配顺序，谁登记的受试者，谁将受试者分组
盲法（掩饰）	11	受试者、实施干预和评估结果的人是否不知道分组情况，如果使用了盲法，如何评价盲法是否成功
统计学方法	12	用于比较组间主要结果的统计学方法，附加分析如亚组分析和调整分析的方法
结果     受试者流动	13	各阶段受试者的流动（极力推荐一种流程图）。特别是报告各组随机分配、接受治疗、完成研究草案和接受分析主要结果的受试者的数量；描述研究计划与草案背离情况及原因
募集	14	界定募集和随访的时间
基底资料	15	各组的基底人口和临床特征
分析的数量	16	分析各组的受试者数量（分母）以及分析是否采用“有意处理”法（intention-to-treat analysis）。如果可行的话。
结果和估计	17	总结各组的主要和次要结果，评估效应大小和精确度（如95%可信区间）
辅助分析	18	说明报告其他分析的多样性，包括亚组分析和调整分析，指出哪些是预定的，哪些是探索性的
负性事件	19	各组的所有重要负性事件或不良反应
讨论     解释	20	解释结果，考虑研究假设，分析发生潜在偏倚和不精确的原因，分析和结果多样性相关的危险性
可推广性	21	试验结果的可推广性（外部有效性）
全部证据	22	根据现有结果，全面解释结果

 

CONSORT Statement 2001 - Checklist

Items to include when reporting a randomized trial  

PAPER SECTION And topic	Item	Descriptor	Reported on Page #
TITLE & ABSTRACT	1	How participants were allocated to interventions (e.g., "random allocation", "randomized", or "randomly assigned").
INTRODUCTION Background	2	Scientific background and explanation of rationale.
METHODS Participants	3	Eligibility criteria for participants and the settings and locations where the data were collected.
Interventions	4	Precise details of the interventions intended for each group and how and when they were actually administered.
Objectives	5	Specific objectives and hypotheses.
Outcomes	6	Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).
Sample size	7	How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.
Randomization -- Sequence generation	8	Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)
Randomization -- Allocation concealment	9	Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.
Randomization -- Implementation	10	Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.
Blinding (masking)	11	Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated.
Statistical methods	12	Statistical methods used to compare groups for primary outcome(s); Methods for additional analyses, such as subgroup analyses and adjusted analyses.
RESULTS Participant flow	13	Flow of participants through each stage (a diagram is strongly recommended). Specifically, for each group report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from study as planned, together with reasons.
Recruitment	14	Dates defining the periods of recruitment and follow-up.
Baseline data	15	Baseline demographic and clinical characteristics of each group.
Numbers analyzed	16	Number of participants (denominator) in each group included in each analysis and whether the analysis was by "intention-to-treat". State the results in absolute numbers when feasible (e.g., 10/20, not 50%).
Outcomes and estimation	17	For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., 95% confidence interval).
Ancillary analyses	18	Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those pre-specified and those exploratory.
Adverse events	19	All important adverse events or side effects in each intervention group.
DISCUSSION Interpretation	20	Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.
Generalizability	21	Generalizability (external validity) of the trial findings.
Overall evidence	22	General interpretation of the results in the context of current evidence.

 

点击下面网址可找到中英文版报告随机试验所含项目核对表原始出处。

中文版见：
http://www.consort-statement.org/mod_product/uploads/CONSORT%20Statement%202001_Chinese.pdf

英文版见：
http://www.consort-statement.org/mod_product/uploads/CONSORT%202001%20checklist.pdf