Introduction Consolidated Standards of Reporting Trials （CONSORT）, encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled ...Introduction Consolidated Standards of Reporting Trials （CONSORT）, encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials （RCTs）.展开更多
Objective： To evaluate and compare the reports＇ qualities of acupuncture randomized controlled trials （RCTs） conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standar...Objective： To evaluate and compare the reports＇ qualities of acupuncture randomized controlled trials （RCTs） conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standards of Reporting Trials （CONSORT） statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture （STRICTA）. Methods： Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines. In addition, the total score of each item＇s reporting were calculated and reported differences during different date ranges were compared. Results： For CONSORT items （maximum score 8）, there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined （2.5 ± 0.6） and 2004-2006 and 2009-2010 combined （3.0 ± 0.9; difference 0.4, 95% confidence interval, 0.3 to 0.6, P〈0.01）. For STRICTA items （maximum score 17）, there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined （8.6±2.1） and 2004-2005 and 2009-2010 combined （10.1 ±1.8; difference 1.5, 95% confidence interval, 1.1 to 1.9, P〈0.01）. Conclusion： Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.展开更多
There had been no standardized rules for citing ethical Kampo products used in clinical trials in journal articles. Although the name of a Kampo manufacturer was described in 77.9% of research articles, the name and r...There had been no standardized rules for citing ethical Kampo products used in clinical trials in journal articles. Although the name of a Kampo manufacturer was described in 77.9% of research articles, the name and ratios of crude drug components of Kampo formulas were not described in 77.5% of these papers. Considering the importance of proper characterization of interventions in the Consolidated Standards of Reporting Trials （CONSORT） checklist, we hereby propose the use of the Standards of Reporting Kampo Products （STORK） website, http：//mpdb.nibiohn.go.jp/stork, as a reference for Kampo products. This will provide an official source on the internet for verified information on individual Kampo formulations for citation purposes in clinical research articles.展开更多
目的:评价黄芪注射液治疗慢性心力衰竭的随机对照试验报告质量。方法:检索包括PubMed,Cochrane Central Register of Controlled Trials,EMBASE,中国生物医学文献数据库,中国期刊全文数据库等电子文献数据库同时配合手工检索,广泛收集...目的:评价黄芪注射液治疗慢性心力衰竭的随机对照试验报告质量。方法:检索包括PubMed,Cochrane Central Register of Controlled Trials,EMBASE,中国生物医学文献数据库,中国期刊全文数据库等电子文献数据库同时配合手工检索,广泛收集黄芪注射液治疗慢性心力衰竭的随机对照研究。根据《中医药临床随机对照试验报告规范(征求意见稿)》制定黄芪注射液治疗慢性心力衰竭的报告质量评价表,对符合纳入标准的文献进行描述性分析。结果:共有107篇报道为"随机"对照试验的文献被纳入评价。根据评价表的22项原则逐一进行评估。全部文献文题表述均不完整,54篇(50.5%)文献有摘要,仅有26篇(24.3%)文献有引言。77篇(72.0%)文献没有明确的纳入及排除标准,11篇(10.3%)文献未提及诊断标准,无1篇文献记录知情同意书签署及伦理委员会审批情况,所有研究均未提及确定样本量的依据和终止试验的原则。91个(85.0%)研究没有说明随机序列产生的方法。32个(29.9%)研究未说明采用何种统计学方法。79个(73.8%)研究从性别、年龄、心功能等方面描述了基线情况。54个(50.5%)研究对试验中的不良反应进行了报道。30个(28.0%)研究提出了试验结果具有可推广性。所有研究均未提及研究者与试验的相关利益冲突。结论:通过对纳入的107篇文献评估发现,大部分研究者对临床试验方案的设计及实施报道不明确,特别是在方法学方面存在较多问题。展开更多
Objective： To determine the extent to which Chinese medical （CM） journals incorporate Consolidated Standards for Reporting of Trials （CONSORT） into their ＂instruction to authors＂. Methods： We reviewed the late...Objective： To determine the extent to which Chinese medical （CM） journals incorporate Consolidated Standards for Reporting of Trials （CONSORT） into their ＂instruction to authors＂. Methods： We reviewed the latest ＂instruction to authors＂ of the CM journals in China which indexed by MEDLINE in 2010 or Excerpta Medica Database （EMBASE） in 2012 and extracted all information of CONSORT, International Committee of Medical Journal Editors （ICMJE）, other reporting guidelines or clinical trial registration. By reading the instructions to authors and reviewing recent studies published in those journals, those that do not publish clinical trials were excluded. We also contacted each of journals by telephone on contributor＇s status to ask them whether mentioned CONSORT in their instructions and incorporated it into their editorial and peer-review process. Full-text papers of randomized controlled trials （RCTs, from January 2011 to March 2012） published in the journals which mentioned ＂CONSORT＂ in their instructions for authors were downloaded. Results： Seven CM journals were included. Three of these journals mentioned CONSORT in its instructions. By telephone survey, all journals gave responses and all respondents knew CONSORT statement. Three of 7 journals required authors to comply with the CONSORT statement and provide the CONSORT checklist and a flow chart of the trial. The rest 4 journals recommended authors of RCTs to refer to the CONSORT statement. From January 2011 to March 2012, a total of 50 RCTs were obtained from the 3 journals endorsing the CONSORT statement; 17 （17/50, 34%） contained a flow diagram in their manuscript, and none of those RCTs had mentioned the trial registration information. Conclusions： The endorsement of CONSORT by CM journals＇ ＂instruction to authors＂ was not satisfactory. The spread of CONSORT endorsement should be wider in instructing the performance of CM clinical trials in the future. Chinese journals should introduce CONSORT to their authors and require authors to comply with CONSORT when they submit their research.展开更多
Randomized controlled trials (RCTs) are considered the first level of evidence to assess the efficacy of novel interventions/therapies.Proper design and implementation of an RCT can result in convincing causal inferen...Randomized controlled trials (RCTs) are considered the first level of evidence to assess the efficacy of novel interventions/therapies.Proper design and implementation of an RCT can result in convincing causal inferences.RCTs often represent the gold standard for clinical trials when appropriately designed,conducted and reported.However,there are limitations in implementation of RCTs,including sufficiency of randomized allocation (especial for allocation concealment),implementing standard intervention,maintaining follow-up and statement of conflicting interests.Therefore,the basic principles of RCTs are outlined here so that pediatric investigators can further understand what is the best evidence based on RCTs.More importantly,the quality of pediatric RCTs may be improved by following challenges in pediatric clinical trials outlined here.展开更多
文摘Introduction Consolidated Standards of Reporting Trials （CONSORT）, encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials （RCTs）.
基金Supported by National Natural Science Foundation for Distinguished Young Scholars of China(No.81303069)
文摘Objective： To evaluate and compare the reports＇ qualities of acupuncture randomized controlled trials （RCTs） conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standards of Reporting Trials （CONSORT） statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture （STRICTA）. Methods： Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines. In addition, the total score of each item＇s reporting were calculated and reported differences during different date ranges were compared. Results： For CONSORT items （maximum score 8）, there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined （2.5 ± 0.6） and 2004-2006 and 2009-2010 combined （3.0 ± 0.9; difference 0.4, 95% confidence interval, 0.3 to 0.6, P〈0.01）. For STRICTA items （maximum score 17）, there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined （8.6±2.1） and 2004-2005 and 2009-2010 combined （10.1 ±1.8; difference 1.5, 95% confidence interval, 1.1 to 1.9, P〈0.01）. Conclusion： Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.
基金Financial support was provided by the following sources to convene a meeting of the CONSORT Group in Montebello Canada+9 种基金in January 2007:the American Society of Clinical OncologyBMJCanadian Institutes for Health ResearchJohnson & JohnsonThe LancetNordic Cochrane CentrePLoS Medicine UK Cochrane Centreand 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)。
文摘背景: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。
文摘There had been no standardized rules for citing ethical Kampo products used in clinical trials in journal articles. Although the name of a Kampo manufacturer was described in 77.9% of research articles, the name and ratios of crude drug components of Kampo formulas were not described in 77.5% of these papers. Considering the importance of proper characterization of interventions in the Consolidated Standards of Reporting Trials （CONSORT） checklist, we hereby propose the use of the Standards of Reporting Kampo Products （STORK） website, http：//mpdb.nibiohn.go.jp/stork, as a reference for Kampo products. This will provide an official source on the internet for verified information on individual Kampo formulations for citation purposes in clinical research articles.
文摘目的:评价黄芪注射液治疗慢性心力衰竭的随机对照试验报告质量。方法:检索包括PubMed,Cochrane Central Register of Controlled Trials,EMBASE,中国生物医学文献数据库,中国期刊全文数据库等电子文献数据库同时配合手工检索,广泛收集黄芪注射液治疗慢性心力衰竭的随机对照研究。根据《中医药临床随机对照试验报告规范(征求意见稿)》制定黄芪注射液治疗慢性心力衰竭的报告质量评价表,对符合纳入标准的文献进行描述性分析。结果:共有107篇报道为"随机"对照试验的文献被纳入评价。根据评价表的22项原则逐一进行评估。全部文献文题表述均不完整,54篇(50.5%)文献有摘要,仅有26篇(24.3%)文献有引言。77篇(72.0%)文献没有明确的纳入及排除标准,11篇(10.3%)文献未提及诊断标准,无1篇文献记录知情同意书签署及伦理委员会审批情况,所有研究均未提及确定样本量的依据和终止试验的原则。91个(85.0%)研究没有说明随机序列产生的方法。32个(29.9%)研究未说明采用何种统计学方法。79个(73.8%)研究从性别、年龄、心功能等方面描述了基线情况。54个(50.5%)研究对试验中的不良反应进行了报道。30个(28.0%)研究提出了试验结果具有可推广性。所有研究均未提及研究者与试验的相关利益冲突。结论:通过对纳入的107篇文献评估发现,大部分研究者对临床试验方案的设计及实施报道不明确,特别是在方法学方面存在较多问题。
文摘Objective： To determine the extent to which Chinese medical （CM） journals incorporate Consolidated Standards for Reporting of Trials （CONSORT） into their ＂instruction to authors＂. Methods： We reviewed the latest ＂instruction to authors＂ of the CM journals in China which indexed by MEDLINE in 2010 or Excerpta Medica Database （EMBASE） in 2012 and extracted all information of CONSORT, International Committee of Medical Journal Editors （ICMJE）, other reporting guidelines or clinical trial registration. By reading the instructions to authors and reviewing recent studies published in those journals, those that do not publish clinical trials were excluded. We also contacted each of journals by telephone on contributor＇s status to ask them whether mentioned CONSORT in their instructions and incorporated it into their editorial and peer-review process. Full-text papers of randomized controlled trials （RCTs, from January 2011 to March 2012） published in the journals which mentioned ＂CONSORT＂ in their instructions for authors were downloaded. Results： Seven CM journals were included. Three of these journals mentioned CONSORT in its instructions. By telephone survey, all journals gave responses and all respondents knew CONSORT statement. Three of 7 journals required authors to comply with the CONSORT statement and provide the CONSORT checklist and a flow chart of the trial. The rest 4 journals recommended authors of RCTs to refer to the CONSORT statement. From January 2011 to March 2012, a total of 50 RCTs were obtained from the 3 journals endorsing the CONSORT statement; 17 （17/50, 34%） contained a flow diagram in their manuscript, and none of those RCTs had mentioned the trial registration information. Conclusions： The endorsement of CONSORT by CM journals＇ ＂instruction to authors＂ was not satisfactory. The spread of CONSORT endorsement should be wider in instructing the performance of CM clinical trials in the future. Chinese journals should introduce CONSORT to their authors and require authors to comply with CONSORT when they submit their research.
文摘Randomized controlled trials (RCTs) are considered the first level of evidence to assess the efficacy of novel interventions/therapies.Proper design and implementation of an RCT can result in convincing causal inferences.RCTs often represent the gold standard for clinical trials when appropriately designed,conducted and reported.However,there are limitations in implementation of RCTs,including sufficiency of randomized allocation (especial for allocation concealment),implementing standard intervention,maintaining follow-up and statement of conflicting interests.Therefore,the basic principles of RCTs are outlined here so that pediatric investigators can further understand what is the best evidence based on RCTs.More importantly,the quality of pediatric RCTs may be improved by following challenges in pediatric clinical trials outlined here.
