世界主要消化病杂志上随机对照试验报告质量比较分析

The Quality of Reporting of Randomized Trials Related to Digestive Diseases in 2008 and 1998:A Comparative Study

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。

Objective After the publication of the revised CONSORT （CONsolidated Standards Of Reporting Trials） statement, few systematic studies have been conducted to assess the extent of improvement in the quality of RCT （randomized controlled trail） reporting in major gastroenterological and hepatological journals. Method The quality of RCT reporting in five major gastroenterological and hepatological journals published in 1998 or 2008 was analyzed and compared systematically. RCT-related articles were retrieved from MEDLINE using a high sensitivity search method. Their quality was evaluated based on some of the checklist items recommended in the revised CONSORT statement, especially those pertaining to methodology including random sequence generation, sequence concealment, blinding, sample size calculation, and ITF（intent-to-treat） analysis, as well as some other descriptive indicators. Results Our search retrieved a total 107 RCTs published in 2008 and 99 RCTs in 1998. In the RCTs reported in 2008, 76% （81/107） had adequate sequence generation, 58% （62/107） adequate sequence concealment, 58% （62/107） adequate blinding, 78% （83/107） adequate sample size calculation and 69% （74/107） ITI＂ analysis. The corresponding values for RCTs reported in 1998 were 35% （35/99）, 25% （25/99）, 53% （52/99）, 47% （47/99） and 42% （42/99）, respectively. Conclusion The quality of RCT reporting in 2008 has improved significantly comparing to that in 1998, indicating increased awareness of and compliance with the revised CONSORT statement. However, there is still much room for the improvement.