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

The evaluation of clinical studies published in Chinese Pediatric Emergency Medicine during 2011 to 2015 according to CONSORT statement

目的利用CONSORT声明统计和评价《中国d,JL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／J,JL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．t％）、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d,JL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。

Objective To search and evaluate the quality of reports of clinical trial studies published in Chinese Pediatric Emergency Medicine according to CONSORT statement. Methods We collected all ar- ticles published in Chinese Pediatric Emergency Medicine from January 1,2011 to November 31,2015 through searching the WanFang Database, then evaluated and analyzed clinical trial studies. Results Among all 1 317 articles we retrieved,62 （4. 7% ）of them belong to clinical trial study. According to CONSORT statement, all the articles satisfied items from l b to 6b （including abstract, introduction, trial design, partici- pants,interventions and outcomes） ,only 30（48.4% ）and 4（6. 5% ）articles mentioned item 8a（ method used to generate the random allocation sequence）and 8b （type of randomization;details of any restriction）, respec- tively. None of the editors reported item 9 （ mechanism used to implement the random allocation sequence, de- scribing any steps taken to conceal the sequence until interventions were assigned）and 10（ who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions ）. Among 62 included studies ,33 （53.2%）studies concentrated on respiratory system diseases. However, studies about nervous system, circulatory system and digestive system were 5 （ 8.1% ）, 4 （ 6. 5 % ） and 4 （ 6. 5 % ） re- spectively. Although all the results had statistical significance, only 38 （61.3 % ）, 7 （11.3 % ） and 5 （8.1% ） mentioned randomization, follow-up and blinding respectively. Flow diagram was only included in one （ 1.6% ） article. Conclusion The articles of clinical trial studies published in Chinese Pediatric Emergency Medicine did not take CONSORT statement as reference completely.