Tags: CONSORT 临床研究 | 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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