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Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (3): 221-232.doi: 10.3736/jcim20080301

• Editorial •     Next Articles

CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration

S Hopewell1,2, M Clarke1,3, D Moher4,5, E Wager6, P Middleton7, DG Altman2, KF Schulz8, Group CONSORT   

  1. 1. UK Cochrane Centre, Oxford, United Kingdom
    2. Centre for Statistics in Medicine, Wolfson College, Oxford University, Oxford, United Kingdom
    3. School of Nursing and Midwifery, Trinity College Dublin, Dublin, Ireland
    4. Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada
    5. Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Canada
    6. Sideview, Princes Risborough, United Kingdom
    7. Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia
    8. Family Health International, Research Triangle Park, North Carolina, United States of America
  • Received:2008-02-14 Online:2008-03-20 Published:2008-03-15
  • Supported by:
    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.

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.

Key words: journal article, abstracts, Consolidated Standards of Reporting Trials, randomized controlled trials

CLC Number: 

  • R-62


条目 描述
标题 判定为随机研究
作者* 通讯作者的详细联系方式
试验设计 试验设计的描述(例如平行小组、组群、非劣效等)
研究对象 研究对象的合格标准与试验数据采集的场所
干预 各组计划的干预
目的 明确的目的或假设
结局 明确定义该研究的主要结局
随机化 如何分配研究对象进入不同干预组
盲法(遮蔽) 是否对研究对象、医疗护理提供者以及结局评价人员隐瞒了分组方案
随机分组的例数 每组研究对象的人数
招募对象 临床试验状态
分析的例数 每组纳入数据分析的研究对象人数
结局 针对主要结局、每个干预组和所评价效应量的结果及其精确度
危害 重要的不良事件或副反应
结论 对结果概括性的解释
试验注册 试验注册号码和注册机构名称
资助 资助来源
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