Compliance to the CONSORT statement of randomized controlled trials in solid organ transplantation: a 3‐year overview

The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting quality of randomized controlled trials (RCTs). Our primary aim was to assess to what extent reports of RCTs in solid organ transplantation adhere to the 2010 CONSORT statement. Secondly, we investigated the relationship between CONSORT adherence, methodological quality and some other factors. We included 290 RCTs that were published between 2007 and 2009. We examined to what extent trial reports complied with 30 items of the CONSORT statement. Methodological quality was evaluated using the Jadad scale plus allocation concealment and whether data analysis was by randomized group (intention to treat). On average, trial reports addressed 47% of the CONSORT items. Forty‐three per cent of RCTs was considered to be of good quality according to Jadad scale, and the items allocation concealment and data analysis were satisfied in approximately one‐third of trials. Good quality RCTs reported on more CONSORT items than poor quality trials. The methodological quality and adherence to the CONSORT statement of RCTs published in journals that endorse the CONSORT statement was superior to those in journals without CONSORT endorsement. Overall compliance with the CONSORT statement and the methodological quality of RCTs in organ transplantation remains unsatisfactory.     

Adherence of Randomized Controlled Trials to Consolidated Standards of Reporting Trials 2010 Guidelines: A Survey of Randomized Controlled Trials Published in 2011-2016 in 3 Periodontology Journals

ObjectiveTo assess the quality of reporting of randomized controlled trials (RCTs) in the Journal of Clinical Periodontology (JCP), Journal of Periodontology (JOP), and Journal of Periodontal Research (JPR), published in the years 2011 until 2016, using Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines.MethodsA thorough search of PubMed for RCTs published between January 2011 and December 2016 in the three journals was carried out. The CONSORT 2010 checklist (36 questions) was used to evaluate the adherence of these RCTs to these guidelines. A modified CONSORT score was calculated and categorized as “perfect” (100%), “excellent” (80%-99%), “good” (60%-79%), “modest” (40%-59%), and “poor” (<40%).ResultsA total of 369 RCTs were published in the three periodontology journals from 2011 until 2016. Based on the modified CONSORT score among all the RCTs, title, abstract, and introduction sections of the included RCTs showed good adherence to the CONSORT 2010 guidelines (60%-79%), whereas the adherence was poor for half the items in methodology (<40%), results (<40%), and discussion (40%). The highest modified CONSORT score was obtained for the trials published in the JCP from 2011 to 2016, whereas the lowest score was achieved by the RCTs in the JPR. Overall, none of the RCTs in any of the journals were perfect in reporting the trials as per the guidelines. Almost half of the RCTs in the JCP showed good adherence (51.1%), whereas almost three-fourths of the RCTs in the JOP (72%) and JPR (82.7%) showed modest to poor adherence as per the reporting guidelines (P < .001).ConclusionAmong the three periodontology journals assessed, the JCP showed better adherence than the JOP and JPR from 2011 until 2016.     

不良反应CONSORT声明扩展版中文译文的评论

我非常喜悦与荣幸地看到,不良反应CONSORT声明扩展版被译为中文并在<中国循证医学杂志>上发表[1].中国对全球科学研究,尤其是医学研究的贡献正以迅猛的速度扩大和发展.两三年前我第一次惊喜地发现,中文生物医学期刊数量已同PubMed收录的大部分英文期刊总量不相上下.     

利用CONSORT声明评价2011至2015年《中国小儿急救医学》杂志临床试验研究报告质量

目的 利用CONSORT声明统计和评价《中国小儿急救医学》杂志上临床试验研究报告的质量.方法 检索万方数据库,收集从2011年1月至2015年11月发表在《中国小儿急救医学》杂志的所有文章,利用2010年CONSORT声明,对临床试验类的文章进行评价和分析.结果 在检索出的1317篇文章中,有62篇(4.7％)属于临床试验.参照CONSORT声明,所有文章均满足从1b到6b项标准(包括摘要,引言,方法中的实验设计、受试者、干预及结局报告的各项要求),而满足项目8a(描述产生随机分配顺序的方法)的有30篇(48.4％),满足项目8b(描述随机化的种类及任何限制)的有4篇(6.5％),没有文章满足项目9(描述实施随机分配顺序的方法,在实施干预前隐蔽分配顺序的步骤)和项目10(谁产生的分配顺序,谁登记的参加者,谁将参加者分配到各组中).在这62篇文章中,33篇(53.2％)所关注的结局为呼吸系统相关疾病,而关注结局为神经系统、循环系统和消化系统疾病的文章分别有5篇(8.1％)、4篇(6.5％)和4篇(6.5％).虽然62篇文章均提示结果有统计学意义,但只有38篇(61.3％)文章提及随机分组、7篇(11.3％)文章提及随访、5篇(8.1％)文章提及盲法,而在文中画出流程图的只有1篇(1.6％).结论 国内临床医生在《中国小儿急救医学》杂志上发表的临床试验报告并没有完全参照CONSORT声明.     

Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting

ObjectiveTo describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials.Study Design and SettingThe AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009.ResultsOf the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011–2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable.ConclusionTrials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously.