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。

Analysis of the Quality of Reports of Randomized Controlled Trials Using CONSORT Statement

Objective To assess the quality of the reports of the "clinical study of efficacy of GnRH-α combined with add back therapy in the treatment of endometriosis" by CONSORT statement.Methods A working team with members familiar with CONSORT statement and visual analogue scale(VAS) approach was organized to evaluate the overall quality of the report "clinical study of efficacy of GnRH-α combined with add back therapy in the treatment of endometriosis".The 25 items in the CONSORT statement was applied,and the findings were scored using VAS approach.Results In the report,15 CONSORT statement items were checked for completeness and accuracy,while the other 10 items were not described.The 25 items of CONSORT statement were scored with VAS:2 items scored 95,4 items scored 90,2 items scored 80,2 items scored 75,2 items scored 60 points,2 items scored 45,1 item scored 23,and 10 items scored 0.For the full text of the report,the average score of VAS for each item was 43.7 points with a standard deviation of 40.0 points,of which 8 items(32%) scored over 80,the 10 items.Conclusion The paper on "clinical study of efficacy of GnRH-α combined with add back therapy in the treatment of endometriosis" is poor in quality.Suggest It is suggested that the CONSORT statement should be further appliced in the writing and reviewing of RCT reports.