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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (8): 701-741.doi: 10.3736/jcim20100801

• Biomedical Publication •     Next Articles

CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials (Chinese version)

David Mohera,Sally Hopewellb,Kenneth F Schulzc,Victor Montorid,Peter C G0tzschee,P J Devereauxf,Diana Elbourneg,Matthias Eggerh,Douglas G Altmanb   

  1. a Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, Canada, K1H 8L6
    b Centre for Statistics in Medicine, University of Oxford,Wolf son College,Oxford,UK
    c Family Health International, Research Triangle Park, NC 27709, USA
    d UK Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, MN, USA
    e The Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark
    f McMaster University Health Sciences Centre, Hamilton, Canada
    g Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London, UK
    h Institute of Social and Preventive Medicine (ISPM) , University of Bern, Switzerland
  • Received:2010-07-21 Accepted:2010-07-29 Online:2010-08-20 Published:2010-08-15

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias.
A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs.
During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement.
After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias.
This explanatory and elaboration document — intended to enhance the use, understanding, and dissemination of the CONSORT statement — has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included.
The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

Key words: Clinical trials, Randomized controlled trials, Guidelines, CONSORT

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论文章节/主题 条目号 对照检查的条目 报告页码
文题和摘要
1a 文题能识别是随机临床试验 ________
1b 结构式摘要,包括试验设计、方法、结果、结论几个部分(具体的指导建议参见“CONSORT for abstracts”[45, 65] ________
引言
背景和目的 2a 科学背景和对试验理由的解释 ________
2b 具体目的或假设 ________
方法
试验设计 3a 描述试验设计(诸如平行设计、析因设计),包括受试者分配入各组的比例 ________
3b 试验开始后对试验方法所作的重要改变(如合格受试者的挑选标准),并说明原因 ________
受试者 4a 受试者合格标准 ________
4b 资料收集的场所和地点 ________
干预措施 5 详细描述各组干预措施的细节以使他人能够重复,包括它们实际上是在何时、如何实施的 ________
结局指标 6a 完整而确切地说明预先设定的主要和次要结局指标,包括它们是在何时、如何测评的 ________
6b 试验开始后对结局指标是否有任何更改,并说明原因 ________
样本量 7a 如何确定样本量 ________
7b 必要时,解释中期分析和试验中止原则 ________
随机方法:
序列的产生 8a 产生随机分配序列的方法 ________
8b 随机方法的类型,任何限定的细节(如怎样分区组和各区组样本多少) ________
分配隐藏机制 9 用于执行随机分配序列的机制(例如按序编码的封藏法),描述干预措施分配之前为隐藏序列号所采取的步骤 ________
实施 10 谁产生随机分配序列,谁招募受试者,谁给受试者分配干预措施 ________
盲法 11a 如果实施了盲法,分配干预措施之后对谁设盲(例如受试者、医护提供者、结局评估者),以及盲法是如何实施的 ________
11b 如有必要,描述干预措施的相似之处 ________
统计学方法 12a 用于比较各组主要和次要结局指标的统计学方法 ________
12b 附加分析的方法,诸如亚组分析和校正分析 ________
结果
受试者流程(极力推荐使用流程图) 13a 随机分配到各组的受试者例数,接受已分配治疗的例数,以及纳入主要结局分析的例数 ________
13b 随机分组后,各组脱落和被剔除的例数,并说明原因 ________
招募受试者 14a 招募期和随访时间的长短,并说明具体日期 ________
14b 为什么试验中断或停止 ________
基线资料 15 用一张表格列出每一组受试者的基线数据,包括人口学资料和临床特征 ________
纳入分析的例数 16 各组纳入每一种分析的受试者数目(分母),以及是否按最初的分组分析 ________
结局和估计值 17a 各组每一项主要和次要结局指标的结果,效应估计值及其精确性(如95%可信区间) ________
17b 对于二分类结局,建议同时提供相对效应值和绝对效应值 ________
辅助分析 18 所做的其他分析的结果,包括亚组分析和校正分析,指出哪些是预先设定的分析,哪些是新尝试的分析 ________
危害 19 各组出现的所有严重危害或意外效应(具体的指导建议参见“CONSORT for harms”[42] ________
讨论
局限性 20 试验的局限性,报告潜在偏倚和不精确的原因,以及出现多种分析结果的原因(如果有这种情况的话) ________
可推广性 21 试验结果被推广的可能性(外部可靠性,实用性) ________
解释 22 与结果相对应的解释,权衡试验结果的利弊,并且考虑其他相关证据 ________
其他信息
试验注册 23 临床试验注册号和注册机构名称 ________
试验方案 24 如果有的话,在哪里可以获取完整的试验方案 ________
资助 25 资助和其他支持(如提供药品)的来源,提供资助者所起的作用 ________

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项目 描 述
作者 通讯作者的详细联系信息
试验设计 试验设计的描述(例如平行试验、群组试验、 非劣效试验等)
方法:
受试者 受试者的合格标准和数据采集的场所
干预措施 各组拟实施的干预措施
目的 具体目的或假设
结局指标 清楚地说明该项研究的主要结局指标
随机方法 如何分配受试者进入各干预组
盲法(遮蔽) 是否将分组情况对受试者、医护提供者以及 结局测评者设盲
结果:
随机分组的例数 随机分入各组的受试者人数
招募受试者 临床试验状态
纳入分析的例数 每组纳入数据分析的受试者数目
结局 各组主要结局指标的结果及其效应估计值和 精确性
危害 重要的不良事件或副作用
结论 对结果的概括性解释
试验注册 临床试验注册号和注册机构名称
资助 资助来源

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阶段 纳入人数 未纳入或排除的人数 理 由
招募受试者 已评价的招募对象人数 不符合纳入标准的人数或符合纳 这些数字反映参加试验的受试者对全体就诊患者的代表性;它
入标准但拒绝参加试验的人数 们仅与评价外部真实性相关,它们常常未予报告。
随机分配 随机分配的受试者人数 用于定义试验大小和评价试验是否经意向性治疗分析的关键数字
分配治疗 按分配完成治疗的受试者 未按分配完成治疗的受试者人 用于评价内部真实性和解释结果的重要数字;应该给出未接受
人数,按组分别列出 数,按组分别列出 分配的治疗的原因。
随访 按分配完成治疗的受试者 未按分配完成治疗的受试者人 用于评价内部真实性和解释结果的重要数字;应该给出未完成
人数,按组分别列出 数,按组分别列出 治疗或随访的原因。
按计划完成随访的受试者 未按计划完成随访的受试者人
人数,按组分别列出 数,按组分别列出
分析 纳入主要分析的受试者人 未纳入主要分析的受试者人数, 用于评价试验是否经意向性治疗分析的关键数字;应该给出排
数,按组分别列出 按组分别列出 除受试者的原因。

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替米沙坦(N=2 954) 安慰剂(N=2 972)
年龄(岁) 66.9 (7.3) 66.9 (7.4)
性别(女性) 1 280 (43. 3%) 1 267 (42. 6%)
吸烟情况:
还在吸烟 293 (9.9%) 289 (9.7%)
过去吸烟 1 273 (43. 1%) 1 283 (43.2%)
人种:
亚洲 637 (21. 6%) 624 (21.0%)
阿拉伯 37 (1. 3%) 40 (1. 3%)
非洲 51 (1.7%) 55 (1.9%)
欧洲 1 801 (61. 0%) 1 820 (61.2%)
土著 390 (13.2%) 393 (13.2%)
其他 38 (1. 3%) 40 (1.3%)
血压(mm Hg) 140.7 (16.8/81.8) (10.1) 141.3 (16.4/82.0) (10.2)
心率(次/分) 68.8 (11.5) 68.8 (12.1)
胆固醇(mmol/L):
总胆固醇 5.09 (1.18) 5.08 (1.15)
低密度脂蛋白胆固醇 3.02 (1.01) 3.03 (1.02)
高密度脂蛋白胆固醇 1.27 (0.37) 1.28 (0.41)
冠状动脉疾病 2 211 (74.8%) 2 207 (74. 3%)
心肌梗死 1 381 (46.8%) 1 360 (45.8%)
心绞痛 1 412 (47.8%) 1 412 (47.5%)
外周动脉疾病 349 (11.8%) 323 (10.9%)
高血压 2 259 (76. 5%) 2 269 (76. 3%)
糖尿病 1 059 (35.8%) 1 059 (35. 6%)
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