摘要
背景:对于与随机对照试验(randomized controlled trial,RCT)有关的学术会议论文或期刊中发表的文章来说,清楚、明了、信息量充足的摘要是十分重要的,因为读者经常仅仅根据报告的摘要对一个临床试验作出评价。为此,我们需要对"临床试验报告的统一标准(Consolidated Standards of Reporting Trials,CONSORT)声明"进行扩充,制定一个期刊与学术会议论文摘要中报告RCT的必备条目清单。今后在任何期刊发表的论文或学术会议论文摘要中,作者对RCT结果的报告都要包含这些内容。方法与结果:我们根据现有的质量评价工具和基于经验的证据总结出一个条目清单。运用三轮修正式德尔菲法(modified-Delphi process)进行条目筛选。邀请共计109人参与电子网络调查,反馈率为61%。调查结果于2007年1月在加拿大蒙特贝罗举行的CONSORT小组会议中公布,与会的26人中有临床试验实施人员、统计学家、流行病学家以及生物医学编辑。经过讨论最终确定条目,随后对其进行修订以保证这些条目体现了会议期间以及会后的讨论思路。摘要CONSORT建议RCT报告的摘要需要有一个结构化的格式,其中应该包括具体的试验目的、试验设计(随机分配的方法、盲法或遮蔽等)、研究对象(对象描述、随机分组的样本量以及用于分析的样本量)、每组实施的干预、实施的干预对主要疗效结果的影响及其危害、试验结论、试验注册名称和编号以及资金来源。本文对每一条能够找到例子的纳入条目都配有良好报告范例、基本原理以及证据等,十分明了易懂,因此我们建议与清单同时使用。结论:摘要CONSORT旨在改善期刊与学术会议中发表的论文摘要的质量,这将有助于摘要提供详尽清晰的信息,这些信息能够帮助读者对试验的有效性和试验结果的适用性做出正确的评价。
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.
出处
《中西医结合学报》
CAS
2008年第3期221-232,共12页
Journal of Chinese Integrative Medicine
基金
Financial support was provided by the following sources to convene a meeting of the CONSORT Group in Montebello
Canada
in January 2007:the American Society of Clinical Oncology
BMJ
Canadian Institutes for Health Research
Johnson & Johnson
The Lancet
Nordic Cochrane Centre
PLoS Medicine
UK Cochrane Centre
and UK National Co-ordinating Centre for Research Methodology.DM is supported by a University of Ottawa Research Chair.
国家重点基础研究发展计划(973计划)项目资助(No.2006CB504602)。
关键词
期刊论文
摘要
临床试验报告统一标准
随机对照试验
journal article
abstracts
Consolidated Standards of Reporting Trials
randomized controlled trials
