CONSORT for reporting randomized controlled trials in journal and conference abstracts: Explanation and elaboration
CONSORT for reporting randomized controlled trials in journal and conference abstracts: Explanation and elaboration
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DOI：
10.1371/journal.pmed.0050020
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发表时间：
2008-01-01
期刊：
影响因子：
15.8
通讯作者：
Schulz, Kenneth F.
中科院分区：
文献类型：
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作者：
Hopewell, Sally;Clarke, Mike;Schulz, Kenneth F.
背景 与随机对照试验 (RCT) 相关的会议和期刊文章的清晰、透明且足够详细的摘要非常重要，因为读者通常仅根据摘要中的信息对试验进行评估。在这里，我们扩展了 CONSORT（报告试验综合标准）声明，以制定基本项目的最低清单，作者在任何期刊或会议摘要中报告随机对照试验结果时应考虑这些项目。方法和结果我们根据现有的质量评估工具和经验证据生成了一个项目列表。使用经过修改的三轮德尔菲流程来选择项目。总共有 109 名参与者被邀请参加电子调查；回应率为61%。调查结果于 2007 年 1 月在加拿大蒙特贝罗举行的 CONSORT 小组会议上公布，与会者有 26 名，其中包括临床试验人员、统计学家、流行病学家和生物医学编辑。讨论了清单项目是否符合最终清单的资格。随后对清单进行了修订，以确保它反映了会议期间和会后进行的讨论。 CONSORT for Abstracts 建议与 RCT 相关的摘要采用结构化格式。项目应包括试验目标的详细信息；试验设计（例如分配方法、盲法/掩蔽）；试验参与者（即描述、随机数字和分析数字）；针对每个随机组的干预措施及其对主要疗效结果和危害的影响；试验结论；试用注册名称和编号；和资金来源。我们建议将该清单与本解释性文件结合使用，其中包括良好报告的示例、理由和证据（如果有），以纳入每个项目。结论 CONSORT for Abstracts 旨在改进期刊文章和会议记录中发表的随机对照试验摘要的报告。它将帮助这些试验摘要的作者提供希望评估试验有效性及其结果适用性的读者所需的细节和清晰度。
Background Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT ( Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract.Methods and Findings We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design ( e. g., method of allocation, blinding/masking); trial participants (i. e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item.Conclusions CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results.