| 期刊与学术会议论文摘要中报告随机对照试验的CONSORT声明：说明与详述 |
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| 作者姓名： | Sally Hopewell ;Mike Clarke ;David Moher ;Elizabeth Wager ;Philippa Middleton ;Douglas G. Altman ;Kenneth F. Schulz |
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| 作者单位： | [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 |
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| 基金项目： | Johnson & Johnson，国家重点基础研究发展计划(973计划)，The Lancet |
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| 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。句此，我们需要对“临床试验报告的统一标准（Consolidated Standards of Reporting Trials,ials-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。争后在任阿期刊发表的论文或学术会议论文摘要中，怍者对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%。调查结果干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，其中立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制、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。
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| 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 |
| 文章编号： | 1672-1977(2008)03-0221-12 |
CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration |
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| Sally Hopewell,;Mike Clarke,;David Moher,;Elizabeth Wager,;Philippa Middleton,;Douglas G. Altman,;Kenneth F. Schulz.CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration[J].Journal of Chinese Integrative Medicine,2008,6(3):221-232. |
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| Authors: | Sally Hopewell Mike Clarke David Moher Elizabeth Wager Philippa Middleton Douglas G Altman Kenneth F Schulz the CONSORT Group |
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| Institution: | Altman , Kenneth F. Schulz , and the CONSORT Group(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) |
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| Abstract: | |
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| Keywords: | journal article abstracts Consolidated Standards of Reporting Trials randomized controlled trials |
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