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Background  Several recommendations are available to conduct and report a systematic review of adverse drug reactions. This study is aimed at identifying and comparing the methodologies of the two most commonly used recommendations to conduct and report systematic reviews on drug’s safety.    Methods  Two systematic reviews were conducted following the recommendations “Cochrane Handbook for Systematic Reviews of Interventions” and “Systematic Reviews’ Centre for Reviews and Dissemination guidance for undertaking reviews in healthcare.” The methods of each recommendation were characterized, and the results and the discussion of each systematic review were also evaluated.    Results  The methodologies of both recommendations are similar. The review question was structured. Both recommendations suggest to include pre- and post-marketing data. The recommended data sources differed and, consequently, the results of the systematic reviews (37 vs. 35 studies). Other aspects of search literature were identical. Different tools are suggested to evaluate the methodological quality of the included studies. For case reports, both recommendations only report some questions that may be helpful to assess risk of bias. The reporting of the results and discussion is also identical for both recommendations.    Conclusions  Few methodological differences were observed between the analyzed recommendations to conduct a systematic review on drug’s safety. Combining their methods into a single and recognized recommendation could be of great value.

A comparison between two recommendations to conduct and report systematic reviews on drug’s safety