480 The Quality of Reporting Inflammatory Bowel Disease Randomized Control Trials: A Systematic Review

Abstract

Aim Our objective was to perform a systemic evaluation of the risk of bias of randomized control trials’ (RCTs) reports published on IBD. Method We assessed the risk-of-bias using the Cochrane tool, as indicators for poor methodology or subsequently poor reporting. We focused on assessing the risk-of -bias pertaining to appropriate sequence generation, allocation concealment, blinding, incomplete outcome data reporting and other bias. We systematically selected, with dual independent judgements, all studies published on IBD with no time limits and assessed the methodological quality of included studies again using independent dual ratings, with disagreement solved through a third author. Results 563 full texts were included after selection and review. When excluding blinding, 103 papers exhibited low risk of bias in all reporting domains, none of which were publications. RCTs published in journals with higher IF were associated with an overall reduced rate of being at high risks. However, only 6% of full RCT publications in journals with IF greater than 10, published in the past 5 years, were free of bias. The trend over time is towards improved reporting in all areas. Trials published by larger author teams, in full-text form and by industry and public sponsorship were positively correlated with lower risk of bias. Only allocation concealment showed a statistically significant improvement with time (p = 0.037). Conclusions These findings are consistent with those of other specialties in the literature. Whilst this may represent poor reporting instead of poor quality, it leaves readers and future secondary researchers with significant questions regarding such key issues.