2010版CONSORT声明：平行组随机试验报告的新指南

平行组随机试验（parallel group random-ised trials）的统一报告格式CONSORT声明于1996年首次发表后,在实用中受到好评,对规范试验报告格式、提高试验报告质量发挥了重要作用,可作为试验报告的作者、审稿人和编者撰写、评价和发表的重要指南。本着不断改进的宗旨,CONSORT声明于2001年进行了修订,2010年再次进行修订。目前,国际上400多本期刊和3个主流的国际性编辑组织对CONSORT给予官方支持。最新版本CONSORT2010改进了以前核查单的特定性和清晰性。本文将对2010版的CONSORT声明进行介绍,展示报告平行组随机对照试验的完整指南框架,期望对规范我国临床试验报告工作有所裨益,以不断提高我国临床试验报告的质量。     

随机对照试验Meta分析的统一报告格式:QUOROM声明

随机对照试验作为循证医学研究中最有力的证据得到公认，基于随机对照试验的系统评价，为探求当前最佳的医疗证据提供了有效途径。而Meta分析是系统评价的基本方法，如何规范Meta分析报告，能为临床医疗实践提供切实可行的防治决策依据，是近年许多学致力研究的方向。QUOROM小组在回顾既往报告的基础上，改进不足，充分研讨，提出了一种统一的报告格式，即QUOROM声明。该声明包括一份核查单和一幅流程图，对规范报告格式、提高报告质量具有指导作用，目前已得到许多国际名医学期刊的认可，并作为Meta分析报告的作、审稿人和编撰写、评价和发表的重要指南。本对QLIOROM声明形成的背景、过程及其内容和要求进行介绍，展示了报告Meta分析结果的完整框架，期望对规范我国随机对照试验Meta分析报告工作有所裨益，以不断提高我国Meta分析论的质量。     

临床随机对照试验报告规范

临床试验建立于《优良临床试验规范》（Good Clinical Prractice）（GCP）基础，确保合乎科学和伦理。临床试验是在人身上进行，主要目的，是为了减少病人的痛苦，提高人类的健康，造福社会，因此要遵循一般的伦理道德规范，保护受试者的权益。而针灸临床试验在1995年由卫生组织（WHO）公布《针灸临床试验规范》（Guidelines for Clinical Re-search on Acupuncture）。临床试验的质量决定包括试验设计、实施和报告。严谨的临床试验是按照GCP规定的随机对照研究方法（RC7）进行，临床试验基地，要培训研究人员及临床试验的质量。证据医学（EBM）提供临床试验严格评价，促进临床试验的报告规范化，以确保临床试验的质量。1996年即提出《临床随机对照试验报告规范标准》，声明CONSORT（Consolidate Standards of Rcpoding Trials），2000年提出修订版，2001年正式发表。CONSORT声明中文版在2001年《中国循证医学杂志》发表。     

应用临床试验报告规范提高医学论文质量

<正>临床试验报告规范(good publication practice,GPP)指按照随机对照试验报告的统一规范(CONSORT声明)系列为代表或其他临床试验论文写作和发表规范或指南,写作和发表临床试验报告,其实质就是要求报告者将研究设计、试验实施过程和结果测量标准、方法及过程按规范要求和质量标准完整、清楚地描述出来。如果不准确或有选择地报     

用CONSORT声明评价《中国新药与临床杂志》发表的脑血管疾病随机对照试验报告的质量

目的评价《中国新药与临床杂志》刊出的有关脑血管疾病的随机对照试验(RCT)的质量。方法计算机联合手工检索《中国新药与临床杂志》1989年1月―2012年12月刊载的脑血管疾病RCT,按照CONSORT 2010声明对照检查清单的25个条目制定评价表,对纳入的每篇文献进行分配,每一条目根据作者是否报告,给出"是"或"否"判断,分别计算每个条目报告百分比,对1989―1999年和2000―2012年12月发表的RCT报告质量进行对比,使用SPSS19.0软件进行统计分析。结果纳入51篇RCT,2000―2012年12月与1989―1999年发表的脑梗死RCT相比,其在文题摘要(1a)、受试者(4b)、样本量(7b)、随机序列产生(8a、8b)、分配隐藏(9)、随机方法的实施(10)、盲法(11a、11b)、受试者流程(13b)、招募受试者(14a)、基线资料(15)、局限性(20)、资助(25)等条目的报告质量有一定改善,4b、(8a、8b)、10、13b的报告率有明显的增长(P<0.05)。虽然RCT的关键条目-方法学部分的8b、9、10、(11a、11b)较之前实现了0的突破,仍然存在报告不充分或不准确的问题。结论《中国新药与临床杂志》1989―2012年发表的脑血管疾病的RCT在方法学的报告方面存在一些不足,影响了脑血管疾病治疗的真实评价。建议今后撰稿人报告RCT与审稿人接受RCT论文时均应参考CONSORT声明。     

应用CONSORT标准评价中医药治疗肠易激综合征随机对照试验报告的质量

目的:应用CONSORT2010标准评价5种核心期刊近5年发表的中医药治疗肠易激综合征随机对照试验的报告质量。方法:电子检索中国知网(CNKI)、中文科技期刊数据库(VIP)、万方数据库2009年至2013年发表在5种核心期刊中医药治疗肠易激综合征的RCT。由2名研究者按照CONSORT2010标准对照检查清单制定统一的评价表对纳入的每篇文献进行分配,每一条目根据作者是否报告,给出"是"或"否"判断并进行分析。结果:共纳入18篇文献,在报告质量上均存在不同程度的问题,主要在文题、样本量、分配隐藏、实施、盲法、基线资料、辅助分析、危害、局限性、试验注册、试验方案及资助等方面。结论:能够达到CONSORT2010标准的高质量的中医药治疗肠易激综合征的随机对照试验很少,在接纳和运用其结果时应谨慎。     

中药抗病毒注射剂治疗呼吸道感染随机对照试验Meta分析文献的质量评价

目的:为提高国内Meta分析研究水平提供参考。方法:以检索到的13篇国内中药抗病毒注射剂随机对照试验的Meta分析报告为研究样本,采用QUOROM声明、CONSORT声明、Jadad评分标准、Sacks等提出的Meta分析质量评价方法综合评价13篇Meta分析报告的质量。如果有争议采取讨论和仲裁方式解决。结果:13项研究的平均得分为(64±10.13)分,最高得分为84分,最低为52分。此次质量评价中考虑了5个方面的25个项目,13项研究都覆盖了这5个方面,对25个项目的覆盖率最低为60%,最高为88%。结论:Meta分析的应用在我国已取得长足进步,为使Meta分析结果更完善,更具可靠性,仍需对Meta分析方法的应用加以规范,只有规范严谨的分析方法才能得到可靠正确的结论。     

随机对照试验研究与观察性研究的系统比较

目的:对随机对照试验研究与观察性研究进行系统性地比较,为临床研究者选择合适的设计类型提供借鉴和参考。方法:比较随机对照试验研究与观察性研究的研究设计、研究报告范式,并检索Pub Med数据库、中国期刊全文数据库中的文献,分析国内外随机对照试验研究与观察性研究文献发表的差异。结果:随机对照试验研究与观察性研究在设计原则、研究目的、研究对象、干预措施、效度等多方面均存在差异。CONSORT声明和STROBE声明对两种研究报告范式的题目和摘要、引言、结果、讨论等内容的要求基本一致,主要差别在于方法和其他信息方面。国外随机对照试验研究与观察性研究的文献数量相差较小,而国内相差较大,特别是在证据等级较高的队列研究方面。结论:观察性研究近年来发展迅速,但随机对照试验研究仍然是临床研究中评价因果效应的"金标准",研究者在进行研究时应根据实际情况选择合适的设计类型。     

临床试验研究方案设计中的统计学要素

临床试验方案设计是临床研究的首要环节。一份撰写规范的临床研究计划方案可以明确研究目的、指导临床试验研究的规范开展。临床研究方案的设计是一项科学、严谨的工作，在满足临床诊疗需求的前提下，须遵从统计学要求规范。参考随机对照试验报告统一标准（CONSORT）声明、PICO原则和我国《药物临床研究质量管理规范》，本文从临床研究设计类型入手，介绍随机化方案、对照设置、重复、盲法、终点指标、分析集、数据监察管理委员会、缺失数据及数据填补方法、统计分析和亚组分析等临床研究方案设计中的统计学要素，以期为研究者开展临床研究方案撰写提供参考。     

不良事件报道规范:随机试验报道统一标准的增补

1996年，世界几家著名医学期刊的编辑和有关方面的专家发表了《随机试验报道的统一标准》（CONSORT，Consolidated Standards of Reproting Trials）。2001年，他们对该标准进行了修订。由于许多证据显示，随机对照试验中有关干预措施的损害或不良事件的报道有待进一步改善和提高，他们通过检索证据、开会讨论、拟写初稿、     

Evaluation of the quality of publications on randomized clinical trials using the Consolidated Standards of Reporting Trials (CONSORT) statement guidelines in a Spanish tertiary hospital

The main reason for conducting a clinical trial (CT) is to test the effect of a drug or medical procedure to improve treatment of a disease. CTs contribute most when they are rigorously conducted and the results are published adequately. The aim of this study is to assess, using the CONSORT statement guidelines, the quality of reporting of completed CTs conducted at a tertiary hospital to determine which sections of the articles should be improved. CTs published between 2002 and 2008 were identified by searching the MEDLINE and Cochrane Library. Forty of 127 completed CTs were published. There was a marked increase in the number of articles and the quality of the journals that published the CTs over time. Although the articles were published in high-impact index journals, the Consolidated Standards of Reporting Trials (CONSORT) score reporting quality of the articles varied substantially, which indicates that they should be improved. The title, abstract, introduction, and discussion sections received the highest CONSORT scores and need little improvement. Poor reporting of methodological details and discussion on limitations and strengths were observed. In conclusion, much improvement remains to be made in the quality of reporting of CTs to allow reliable quality assessment of published trials.     

Improving the quality of reporting alcohol outcome studies: Effects of the CONSORT statement

It is critical that the reporting of randomized controlled trials (RCTs) be transparent and comprehensive. The aim of this study was to examine if adopting standards of reporting, the Consolidated Standards of Reporting Trials (CONSORT), improved the quality of reporting of alcohol treatment outcome studies. RCTs were identified from eight journals publishing a substantial number of alcohol treatment outcome studies (n = 127 RCTs) and coded for the quality of reporting according to the CONSORT guidelines. Both CONSORT adopter and non-adopter journals showed significant improvements in the quality of reporting of alcohol treatment outcome studies over time. While overall results suggested a non-significant trend for more improvement over time in the quality of reporting for adopter compared to non-adopter journals, comparison of effects sizes suggested that specific areas of reporting did significantly improve for the adopter journals. Results suggest that efforts to improve reporting such as the CONSORT guidelines can be useful and influential.     

Of consents and CONSORTs: reporting ethics,law, and human rights in RCTs involving monitored overdose of healthy volunteers pre and post the "CONSORT" guidelines

Randomized controlled trials (RCTs) of therapeutic interventions in acute drug overdose present a significant challenge for ethical, legal, and human rights protections of research subjects, particularly when healthy volunteers are involved. The CONSORT statement on the uniform reporting of clinical trials was published in 1996 with the overall aim of improving the reporting of RCTs, both individually and to facilitate their inclusion into systematic reviews. In CONSORT, reporting of ethical, legal, and human rights protections, including prior evaluation of the study by an ethics committee and provision of informed consent, was largely an implicit requirement. Those drafting CONSORT may have assumed such protections and the rights of study subjects were secured by existing doctor-patient relationships. Alternatively, CONSORT may have been viewed as likely to indirectly enhance such protections, as a flow-on effect of improved RCT design and reporting. We wished to examine whether such assumptions were justified by examining the reporting of RCTs of simulated overdose in healthy volunteers. We reviewed all reported RCTs involving activated charcoal in healthy human volunteersfor three years before the CONSORT statement (1989, 1990, and 1991) and three years afterwards (1999, 2000, 2001). Presence of documentation of inclusion and exclusion criteria, stopping rules, protocol deviations, information sheets, consent documentation, ethical approvals, conflicts of interest, understanding, refusal, inducements and coercion were recorded. We found a very poor level of reporting of some key ethical, legal, and human rights protections for healthy volunteers in toxicological RCTs. Reporting did not improve with the publication of CONSORT even in relation to requirements specifically included in the guidelines.     

Ethical approval and informed consent reporting in ASEAN journals: a systematic review

Abstract

Background and objective: Scientific publication is a way to disseminate knowledge to the scientific community. However, an article usually has very little information on how and why ethical approval (EA) and informed consent (IC) was obtained, which can make it very difficult for a reader to evaluate the ethical validity of the study. While many internationally recognized journals and publishers have already adopted a high EA/IC reporting standard, many journals still fail to do so. The aim of this study was to explore the EA/IC reporting standards, as well as their implementation, of the Association of Southeastern Asian Nation (ASEAN) member journals.

Methods: A literature search was performed in PubMed for articles that were published in journals from ASEAN member states in 2016. The articles were then reviewed, categorized into study types, and given two scores—one for their EA statement and one for their IC statement—ranging from 0–4. A list of journals was compiled from the articles retrieved and their instructions to authors regarding EA/IC statements were scored on a scale of 0–2. The data was statistically analyzed using Chi-square test (2-sided) with SPSS (version 21) with p-value < .05 being considered statistically significant.

Results: While a high proportion of articles adequately reported EA, many failed to report IC. Journals with better EA and IC instruction scores had a higher percentage of articles that adequately reported EA/IC. There were significant relationships between EA/IC statement scores and journals’ instructions scores (EA: p?=?.002; IC: p?=?.019).

Conclusions: There may be a need for journals to play key roles in advocating the importance of reporting EA and IC by strictly enforcing high EA/IC reporting standards and refusing the publication of articles that fail to comply.     

临床试验文献质量评价量表的制作和评价

目的：制备中文临床试验报告质量评价量表，并且对量表的信度和效度进行初步评价。方法：采用专家咨询法（Delphi法）和小组讨论相结合的方法制定量表，咨询专家包括临床药理学家、临床医生、流行病学家、卫生统计学家和医学杂志编辑。专家咨询分三个阶段，形成临床试验文献质量评价量表及量表说明。为评价量表，从2000年治疗高血压的英文临床试验文献中抽取30篇，由两个评价人员应用量表独立进行评价，计算组内相关系数（ICC）评价量表的信度；对文献同时应用CONSORT声明评价作为对照，计算Kendall等级相关系数来判断其效度。结果：经过10名专家第一阶段的咨询，协调系数W为0．505，19个评价项目高度一致；第二阶段咨询，对19个项目赋予权重，共计100分，完成量表制作。信度评价中总分的组内相关系数ICC为0．921，其中引言部分0．987，材料与方法0．875，实施与结果部分0．902，讨论及其他部分0．966，P均〈0．01。与CONSORT声明的评价结果比较，Kendall相关系数r为0.723，P〈0．01，具有较好的一致性。结论：本研究形成的量表制订过程规范，条目清楚，具有较好的信度和效度。     

临床对照试验文献质量评价的发展与现状

目的：介绍临床试验文献质量评价的发展与现状。方法：检索相关文献进行描述性研究。结果：临床试验文献质量越来越受到重视，国外有不少于25种评价临床试验文献质量的量表，其中CONSORT声明、Jadal量表、Delphi清单和Chalmers量表应用较多。结论：评价临床试验文献质量有多种量表。还存在多量表共存、量表效度的确定和量表制作方法等一些问题。