OBJECTIVES: To examine the methodological quality of drug safety systematic reviews, and to investigate factors associated with the methodological quality of drug safety systematic review by conducting a cross-sectional survey.

METHODS: We searched PubMed to identity published in the Cochrane Database of Systematic Reviews and Core Clinical Journals indexed in 2015, and randomly sampled the studies with 1:1 of Cochrane and non-Cochrane systematic reviews regarding drug safety. We used the AMSTAR tool to assess the methodological quality of included studies. Multivariable linear regression analyses were used to assess the association between the seven specified variables with AMSTAR score.

RESULTS: We included 120 systematic reviews, including 60 Cochrane systematic reviews and 60 non-Cochrane systematic reviews. The mean (standard deviation) overall score for the AMSTAR tool (11 items) in Cochrane systematic reviews was higher than in non-Cochrane systematic reviews (10±0.9 vs. 8.67±0.95; P＜0.001). Multivariable linear regression analyses showed that type of systematic review (P＜0.001) and area of diseases (P=0.01) were the factors associated with the methodological quality.

CONCLUSIONS: Our study showed that Cochrane systematic reviews had better methodological quality than non-Cochrane systematic reviews. Type of systematic review and area of diseases were the factor associated with the reporting and methodological quality, and the methodological quality of non-Cochrane systematic review should be improved in the future.