The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.     

CONSORT 2010说明与详述：报告平行对照随机临床试验指南的更新

大量证据显示随机对照临床试验（randomised controlled trial,RCT）的报告质量不理想。报告不透明,则读者既不能评判试验结果是否真实可靠,也不能从中提取可用于系统综述的信息。最近的方法学分析表明,报告不充分和设计不合理与对治疗效果产生评价偏倚有关。这种系统误差对RCT损害严重,而RCT正是以其能减少或避免偏倚而被视为评价干预措施的金标准。为了提高RCT的报告质量,一个由专家和编辑组成的工作组制定了临床试验报告的统一标准（Consolidated Standards of Reporting Trials,CONSORT）声明。CONSORT声明于1996年首次发表,并于2001年更新。声明由对照检查清单和流程图组成,供作者在报告RCT时使用。许多核心医学期刊和主要国际性编辑组织都已认可CONSORT声明。该声明促进了对RCT的严格评价和解释。2001年,在对CONSORT进行修订时,人们就已经清楚地认识到,解释和说明制定CONSORT声明的原理,有助于研究人员等撰写或评价临床试验报告。一篇CONSORT说明与详述文章于2001年同2001版CONSORT声明一起发表。2007年1月的专家会议之后,对CONSORT声明作了进一步修订并已发表,即＂CONSORT2010声明＂。这次更新对原版对照检查清单作了文字上的修改,使其更为明晰,并收入了与一些新近才认识到的主题相关的建议,如选择性报告结局产生的偏倚。说明与详述文件旨在加强人们对CONSORT声明的理解、应用和传播,这次也作了大量修订,对每一项新增或更新的清单条目的含义和增改理由进行了解释,提供了优秀的报告实例,还尽可能地提供了相关的经验性研究的参考文献。文中收入了若干流程图实例。＂CONSORT2010声明＂、其说明与详述文件,以及相关网站（www.consort-statement.org）,对于改进随机临床试验报告必将有所裨益。     

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

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。     

提高中草药随机对照试验的质量Ⅳ:采用修改后的CONSORT条目评价临床随机对照试验报告的质量

目的:以Cochrane图书馆中有关中草药治疗2型糖尿病系统评价中的66个临床随机对照试验为基础,分析在中草药临床随机对照试验研究报告中存在的问题,以及如何提高临床随机对照试验报告的质量。方法:文献检索2005年7月前发表于Cochrane图书馆的纳入随机对照试验最多的系统评价—中草药治疗2型糖尿病系统评价,共包含66个临床随机对照试验。以原有的CONSORT条目为基础,增加有关中医药方面的5项内容,即中医证型、组方依据、复方组成、制剂类型及质量控制。修订后的CONSORT评估表共包含63项条目,并以此为标准评估66篇临床随机对照试验报告的质量。结果:按修改后的CONSORT条目,66篇临床随机对照试验的总体报告率为19%~44%,中位数32%(标准差8%)。结论:中草药临床随机对照试验报告的总体质量较低。建议:以CONSORT条目为基础,进行中草药临床随机对照试验报告规范化的研究。同时建议中医药类杂志的编辑要求作者按照规范格式发表临床研究报告。     

Value of flow diagrams in reports of randomized controlled trials

CONTEXT: Diagrams of the flow of participants through a clinical trial are recommended in the Consolidated Standards for Reporting of Trials (CONSORT) statement, but it is unclear whether such flow diagrams improve the quality of trial reports. OBJECTIVE: To examine the information contributed by flow diagrams and the completeness of reporting overall in reports of randomized controlled trials (RCTs) published in 5 general and internal medicine journals. DESIGN AND SETTING: Analysis of 270 reports of RCTs published in 1998 in the Annals of Internal Medicine (AIM; n = 19), BMJ (n = 42), JAMA (n = 45), The Lancet (n = 81), and The New England Journal of Medicine (NEJM; n = 83). MAIN OUTCOME MEASURES: Proportion of reports that included a flow diagram, information provided in flow diagrams, and completeness of reporting about flow of participants overall in flow diagrams or text. RESULTS: A total of 139 reports (51.5%) of RCTs included a flow diagram, but this varied widely among journals (AIM, 21.0%; BMJ, 38.1%; JAMA, 80.0%; The Lancet, 93.8%; and NEJM, 8.4%). Diagrams generally provided useful information, but only 73 (52.5%) included the number of participants who received allocated interventions and only 32 (23.0%) included the number of participants included in the analysis. In logistic regression analysis, overall completeness of reporting about flow of study participants was associated with publication of a flow diagram. CONCLUSIONS: Flow diagrams are associated with improved quality of reporting of randomized controlled trials. However, the structure of current flow diagrams is less than ideal. We propose a revised flow diagram that includes all important counts through the stages of parallel group trials.     

Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement

The CONSORT (Consolidated Standards of Reporting Trials) Statement, including a checklist and a flow diagram, was developed to help authors improve their reporting of randomized controlled trials. Its primary focus was on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another but is now being extended to other trial designs. Noninferiority and equivalence trials have methodological features that differ from superiority trials and present particular difficulties in design, conduct, analysis, and interpretation. Although the rationale for such trials occurs frequently, those designed and described specifically as noninferiority or equivalence trials appear less commonly in the medical literature. The quality of reporting of those that are published is often inadequate. In this article, we present an adapted CONSORT checklist for reporting noninferiority and equivalence trials and provide illustrative examples and explanations for those items amended from the original CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions.      

Current situation on the reporting quality of randomized controlled trials in 5 leading Chinese medical journals

Objective： The Consolidated Standards for Reporting of Trials （CONSORT） statement has already proved to be an efficient standard for reporting quality of randomized controlled trials （RCTs）. However, most of the Chinese medical journals have not endorsed the CONSORT statement. The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear. The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals. Methods： We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals （Journal type 1） without adoption of CONSORT and Chinese Journal of Evidence-based Medicine （Journal type 2） which adopted CONSORT in 2004. We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report, gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items. The reporting quality of RCT trials from 2001 to 2003 （pre-adoption period） was compared with that from 2004 to 2006 （post-adoption period）. Results： The average reporting quality of RCTs was moderate （mean score, 15.18）, and the mean score of the 6 core items was low （mean score, 1.09） in 5 leading journals. The difference in the total score and the score of the 6 core items between pre-adoption period （2001-2003） and post-adoption period （2004-2006） was statistically significant （P=0.003; P=0.000）. Interaction between journal type and period was not significant （F=0.76; P=0.383）. We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different. But as to the core items of sequence concealment and intention-to-treat analysis, the increases were greater for Journal type 2 when evaluated against Journal type 1 （P=0.038; P=0.016）. Conclusion： The reporting quality of RCT trials in 5 leading Chinese medical journals is improving. However, the lack of important items in RCT trials remains a serious problem. We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China.     

中文发表的乳腺癌随机对照试验摘要报告质量调查

目的 评价中文发表的乳腺癌随机对照试验(RCT)摘要报告质量。 方法 运用计算机检索主要中文数据库,纳入中文发表的乳腺癌RCT,采用“摘要CONSORT”标准评价纳入RCT摘要的报告质量,使用Meta-Analyst软件进行统计分析。 结果 最终纳入符合标准的RCT 965篇,评价结果显示:乳腺癌RCT摘要中存在严重报告质量缺陷,尤其体现在“标题中判定为随机研究”(1.1%,95%CI:0.6%～2.0%)、“随机化”(3.8%,95%CI:2.8%～5.2%)、“盲法”(1.0%,95%CI:0.6%～1.9%)、“统计方法”(11.5%,95%CI:9.6%～13.7%)、“随机分组的例数”(7.5%,95%CI:6.0%～9.3%)、“招募对象”(12.2%,95%CI:10.3%～14.4%)、“试验注册信息”(13.1%,95%CI:11.1%～15.3%)和“资助来源”(8.1%,95%CI:6.5%～10.0%)8个方面。“摘要CONSORT”发布以后,可以显著提高“研究对象”“干预”“统计方法”“结局”和“结论”的报告率。比较非中国科学引文数据库(CSCD),CSCD收录RCT的摘要在“标题识别随机”“随机化”“招募对象”和“资助来源”的报告上差异有统计学意义。 结论 中文发表乳腺癌RCT摘要存在严重报告缺陷,应当引起期刊编辑和研究员的重视。      

Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation

CONTEXT: The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal. OBJECTIVE: To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs. DESIGN AND SETTING: Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator). MAIN OUTCOME MEASURES: Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument. RESULTS: Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%; mean change, -22%; 95% CI, -38% to -6%). Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8). CONCLUSION: Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs.     

世界主要消化病杂志上随机对照试验报告质量比较分析

目的系统研究主要消化病杂志上发表的随机对照试验报告质量现状。方法系统分析并比较2008年和1998年发表在5本主要消化病杂志上的随机对照试验报告质量。相关文章通过检索MEDLINE获得。质量评价采用CONSORT声明修订版中的部分条目,内容包括随机序号产生、分配隐藏、盲法、样本量估算和意向性处理分析等。结果共检索到2008年的随机对照试验107个,1998年的99个。2008年的随机对照试验中．有76％（81／107）报告了恰当的随机序号产生方法,58％（62／107）报告了恰当的序号隐藏方法,58％（62／107）盲法恰当．78％（83／107）报告了恰当的样本量估算方法,69％（74／107）使用了意向性处理分析;而1998年相应的结果分别为35％（35／99）,25％（25／99）,53％（52／99）,47％（47／99）,42％（42／99）。结论2008年与1998年相比,5本主要消化病杂志上的随机对照试验报告质量有了明显的提高,说明CONSORT声明修订版对于随机对照试验报告质量的提高有很大作用,但目前其报告质量仍有很大的提升空间。     

改进中药临床试验报告的参考条目

为改进中药临床试验报告质量，本文在《草药随机对照临床试验的报告：CONSORT声明细则》的基础上，结合中医药的特点，制定了中药临床试验报告的参考条目。本条目沿用了草药CONSORT声明的22项要求，对其中11项的部分内容根据中医药特点进行了细化和增减，并根据中成药和汤药两大类临床试验的特点，争别对参考条目进行细化；最目突出了受试者（participant）、干预措施（intervention）、对照（control）和结局（outcome）四个方面的内容。制定中药临床武验报告的参考条目旨在提高中药临床试验报告的质量，并为杂志编辑和审稿人员提供参考。     

中文发表的非小细胞肺癌随机对照试验摘要报告质量评价

[摘要] 目的：评价中文发表的非小细胞肺癌(NSCLC)随机对照试验(RCT)报告质量及其影响因素。方法：纳入中文发表的NSCLC领域的RCT,依据“CONSORT”声明的标准评价纳入RCT的报告质量,并分层分析报告质量的影响因素。数据录入采用Excel 2007软件,统计分析用Meta-Analyst软件。结果：检索共获得10 421篇文献,按照纳入排除标准排除后,最终纳入2 677篇RCT分析。评价结果显示纳入的RCT的撰写尚存在许多欠缺,严重报告不足(小于20%)的条目为“题目判定为随机”(69篇,2.58%)、“随机化”(332篇,12.4%)、“盲法”(25篇,0.93%)、“统计方法”(207篇,7.73%)、“招募对象”(209篇,7.81%)、“实验注册”(218篇,8.15%)和“资助”(41篇,1.53%);分层分析结果显示“CONSORT”发表后、作者单位数量≥2和论文页数大于中位页数(3~9页)可以提高报告质量,RCT被CSCD收录和有基金资助对的报告质量无显著改善。结论：中文发表的NSCLC的RCT报告严重欠缺,特别是题目判定为随机、随机化、盲法、统计方法、招募对象、实验注册和资助报告严重不足(报告率小于20%),“CONSORT”发表后对报告质量有改善,但不明显,报告质量还需进一步提高。     

采用CONSORT和STRICTA评价针刺治疗糖尿病胃轻瘫随机对照试验报告质量

[目的] 采用试验报告统一标准(CONSORT)和报告针刺临床试验中干预措施(STRICTA)标准评价针刺治疗糖尿病胃轻瘫随机对照试验的报告质量。 [方法] 计算机检索Cochrane 图书馆临床对照试验数据库、PubMed、中国知识基础设施工程、维普等数据库。文种限制为中英文。纳入针刺治疗糖尿病胃轻瘫的随机对照试验, 并采用CONSORT声明和STRICTA标准进行报告质量评价。[结果] 共纳入针刺治疗糖尿病胃轻瘫随机对照研究28篇文献。根据CONSORT声明和STRICTA标准对纳入文献进行分析, 无文献提及随机分配方案的隐藏、样本量的计算方法和治疗师资历。大部分研究对随机方法描述不清、盲法使用率低、未使用流程图、不良反应报道少、针刺细节报道不充分等问题。[结论] 目前针刺治疗糖尿病胃轻瘫的研究报告质量普遍较低。今后应采用国际公认的CONSORT声明和STRICTA标准对针刺疗法进行规范报告。     

应用CONSORT声明对随机对照试验报告的质量分析

目的应用CONSORT 2010声明评价随机对照试验(RCT)论文的质量。方法组建并培训熟悉CON-SORT 2010声明和视觉模拟(VAS)评分的工作小组,针对论文"促性腺激素释放激素激动剂联合反向添加疗法治疗子宫内膜异位症的临床疗效研究",用CONSORT 2010声明清单的25个条目逐一对照和点评,并对各条目的报告质量给予VAS评分,经过统计学分析之后对论文的整体质量进行评价。结果被评价论文有15个条目提及了完整性和准确性程度不等的内容;对于全文25个条目的报告:VAS得分95分2条、90分4条、80分2条、75分2条、60分2条、45分2条、23分1条、0分10条;每个条目平均VAS评分为(43.7±40.0)分,其中VAS评分在80分以上的有8条,占32%;被评价论文有10个条目未报告,占40%。结论被评价论文报告的质量不高。建议我国RCT的报告仍需规范,报告质量有待提高,尤其是与试验设计原则有关的报告质量;撰稿人报告RCT与审稿人面对RCT论文时均应参照CONSORT声明;编辑部可酌情把CONSORT声明逐步引入稿约;建议用CONSORT声明对照撰写RCT。     

布地奈德辅助治疗小儿肺炎随机对照试验报告摘要质量评价

目的：评价布地奈德辅助治疗小儿肺炎随机对照试验（RCTs）报告摘要质量及分析其影响因素。方法：采用CONSORT 2010申明的临床报告摘要质量评价系统,对中文发表的布地奈德雾化吸入辅助治疗小儿肺炎的RCTs文献摘要进行评价,采用RevMan 5.3软件进行统计学分析。结果：纳入的282篇RCTs摘要报告率低的条目有：“题目判定为随机”“通讯作者”“随机化”“盲法”“随机分组例数” “资助”,且所有文献均无“试验注册”,分层分析中摘要字数对条目报告的影响最大。结论：布地奈德治疗小儿肺炎的RCTs摘要质量与CONSORT 2010申明的临床报告摘要质量存在较大差距,研究人员在今后的文章中应使用CONSORT 规定的条目进行书写以提高摘要质量,增强可读性。     

头针治疗帕金森病：一项随机对照试验的系统评价

Objective: To evaluate the effectiveness of scalp acupuncture (SA), a modern acupuncture technique specialized to neurological disorders, in managing motor function and symptoms for Parkinson''s disease (PD) patients. Methods: Two independent reviewers extracted data from all of the randomized clinical trials (RCTs) that assessed the efficacy of SA for PD compared with conventional therapies (CTs). Sixteen electronic databases were searched. The risk of bias was appraised with the Cochrane Collaboration tool, and the reporting of the included studies was evaluated by the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines. Results: In total, 4 RCTs met the inclusion criteria. As assessed by the Unified PD Rating Scale (UPDRS), 2 RCTs showed that SA combined with CTs proved superior to CTs alone [60 cases; weighted mean difference, –3.94; 95% confidence interval (CI), –6.05 to –1.84, P=0.01; I2=0%]. Based on the Webster scale, however, 3 RCTs showed no superior effect of SA when combined with CTs with high heterogeneity (154 cases; risk ratio, 1.29; 95% CI, 0.79 to 2.12, P=0.30; I2=84%). The Cochrane risk of bias, adherence to the CONSORT and the STRICTA checklist showed that the quality of all the included RCTs was generally low. Conclusions: The result of our systematic review and meta-analysis suggested that the effectiveness of SA for PD is promising, however, the evidence is not convincing. A sham-controlled RCT design that adheres to the CONSORT and STRICTA guidelines to overcome methodological weakness and that includes a large sample size is strongly recommended to confirm the precise effect of SA on PD.     

对耳穴刺激治疗高血压RCT试验报告质量的CONSORT评价

目的:采用CONSROT声明对国内利用耳穴刺激防治高血压病的随机对照试验进行科学评价。方法:系统检索中国生物医学文献数据库、中国知网、维普和万方4个数据库,将国内耳穴刺激防治高血压病的随机对照实验文献全部纳入,并采用国际公认的CONSORT声明进行质量评价。结果:共纳入13篇文献。根据CONSORT条目,在所有纳入文献中,有8篇(61.54%)缺乏文题和摘要;10篇(76.92%)提及受试者纳入排除标准;11篇(84.62%)谈到了研究所用的统计学方法 ;12篇(92.31%)报告了各组的人口学和临床基线资料;尚未有文献提及样本含量估计、分配隐藏、盲法及意向性分析。结论:目前国内耳穴刺激质量高血压病的研究报告质量较低。研究者应采用国际公认的CONSORT声明对临床研究进行规范报告。