Assessment of the influence of sex on oral anticoagulation control in patients taking coumarin derivatives: a systematic review protocol.

OBJECTIVE This review will aim to assess the influence of sex on oral anticoagulation control in patients taking coumarin derivatives. INTRODUCTION Coumarin derivatives, such as warfarin, have a narrow therapeutic index, requiring frequent monitoring to achieve adequate anticoagulation control, which can be assessed by the time in therapeutic range. Differences in the quality of oral anticoagulation control between men and women have been reported, although the current evidence is controversial. A systematic review on this topic would provide results that could be incorporated into clinical practice to enhance oral anticoagulation control and treatment outcomes. INCLUSION CRITERIA Observational and experimental studies were assessed for eligibility, with participants aged ≥18 years of any sex on oral anticoagulation or other coumarin derivatives for ≥3 months, for any indication of chronic use who had oral anticoagulation control evaluated by time in therapeutic range. METHODS Electronic databases to be searched include MEDLINE, BVS, CINAHL, EMBASE, Cochrane CENTRAL, and Web of Science. Two reviewers will independently perform title/abstract selection and screening, and then full text retrieval and screening of articles that meet the inclusion criteria. The evaluation of methodological quality and data extraction will also be performed by two independent reviewers. Data will be synthesized in tables and then the compiled results will be meta-analyzed. In the presence of subgroup differences, meta-regression methods will be used to investigate the effects of categorical or continuous covariates. If statistical pooling is not possible, a narrative synthesis will be presented. SYSTEMATIC REVIEW REGISTRATION NUMBER PROSPERO (CRD42019128329).