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

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 ITT（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） ITT 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.