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 gr法治征文
oup 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 condary outcome measures, including how and when they were assd 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 analys 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 ud to generate the random allocation quence 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 ud to implement the random allocation quence (such as quentially numbered containers), describing any steps taken to conceal the quence until interventions were assigned 遮蔽的细节 | ||
Implementation 随机实施方法 | 10 | Who generated the random allocation quence, 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 孙权是哪国人
assignment to interventions (for example, participants, care providers, tho asssing 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 ud to compare groups for primary and condary outcomes 用于比较组间主要和次要结局的统计学方法 | ||
12b | Methods for additional analys, such as subgroup analys and adjusted analys 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 analyd 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, loss 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 | |||
Baline data 基线数据 | 15 | A table showing baline 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 analyd 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 condary 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, prentation 毕业演讲稿
of both absolute and relative effect sizes is recommended 如果是双终点，都要分别呈现。 | |||
Ancillary analys 辅助分析 | 18 | Results of any other analys performed, including subgroup analys and adjusted analys, distinguishing pre-个人总结护士
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 importan棒球投手
t harms or unintended effects in each group (for specific guidance e CONSORT for harms) 所有重要的有害和意料之外的效应。详细记录AE以及儿子和情人 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 analys 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) | ||
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