P09.58 Quality of randomized controlled trials reporting in the treatment of adult high grade gliomas

Abstract

Abstract Introduction: Randomized Controlled Trial (RCTs) is the gold standard to objectively assess the effect of a treatment. The RCTs methodology must be particularly rigorous to achieve strong evidence of efficiency. To help improve the quality of RCTs, a group of experts established a list of recommendations, adopted by most international journals, called the CONSORT (CONsolidated Standards of Reporting Trials) Statement. First published in 1996, it was actualised in 2001 and 2010. In this study, we assessed the implementation of the CONSORT Statement criteria in the field of adult high grade gliomas. We also aimed to identify criteria associated with higher quality of RCTs. METHODS: We searched PUBMED to retrieve all RCTs concerning high grade gliomas published between the 1st January 1990 and the 1st March 2016. The quality of these RCTs was assessed by completing a modified CONSORT Score containing 33 items. This work was done independently by two investigators and every discordance was resolved by consensus. We also extracted data that seemed relevant to assess the quality of RCTs. Results: Eighty-four published RCTs were identified. The median CONSORT Score was 19 (range: 3-30). Items were not equally reported and items regarding the method of randomization, the blinding or the accessibility of the protocol were reported in less than 25% of RCTs which could raise important biases and led to inappropriate interpretation of the results. However, the CONSORT Score constantly improved over the years. Before the onset of the CONSORT Statement in 1996, the median CONSORT Score was 13 (range: 4-19) whereas it was equal to 18 (range: 3-26) for the period 1996-2004 and equal to 22 (range: 6-30) after 2005. A higher CONSORT Score was observed when RCTs were published in journal with impact factor above 10 (24 vs 17, p<0.001). RCTs that enrolled more than 200 patients had a significantly higher CONSORT Score (20.6 vs 16.4, p=0.004). CONCLUSION: This study demonstrated a continuous improvement over the years of the CONSORT Score of published RCTs in the field of high grade gliomas. We identified three factors associated with a better report of RCTs: the date of publication, the impact factor of the journal and the number of patients included in the study.