Gordon W Fuller1, Rachel Evans2, Louise Preston3, Helen B Woods4, Suzanne Mason2. 1. Centre for Urgent and Emergency Care Research, School of Health and Related Research, University of Sheffield, Sheffield, UK. Electronic address: g.fuller@sheffield.ac.uk. 2. Centre for Urgent and Emergency Care Research, School of Health and Related Research, University of Sheffield, Sheffield, UK. 3. Information Resources, School of Health and Related Research, University of Sheffield, Sheffield, UK; Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Sheffield, UK. 4. Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Sheffield, UK.
Abstract
STUDY OBJECTIVE: Patients receiving direct oral anticoagulant medications commonly undergo computed tomography head scanning after mild traumatic brain injury, regardless of symptoms or signs. International guidelines have noted a lack of evidence to support management decisions for such patients. This systematic review aims to identify, appraise, and synthesize the current evidence for the risk of adverse outcome in patients receiving direct oral anticoagulants after mild head injury. METHODS: A protocol was registered with PROSPERO and review methodology followed Cochrane Collaboration recommendations. Studies of adult patients with mild head injury (Glasgow Coma Scale score 13 to 15) and who were receiving direct oral anticoagulants that reported the risk of adverse outcome after the head injury were eligible for inclusion. A comprehensive range of bibliographic databases and gray literature was examined with a sensitive search strategy. Selection of eligible studies, data extraction, and risk of bias were evaluated independently by separate reviewers. A random-effects meta-analysis was used to provide a pooled estimate of the risk of adverse outcome. The overall quality of evidence was assessed with the Grading of Recommendations Assessment, Development and Evaluation Working Group approach. RESULTS: A total of 4,886 articles were screened for inclusion, of which 7 cohort studies including 346 patients met inclusion criteria. All studies were at high or unclear risk of bias as a result of selection and information bias. Estimates of adverse outcome (any death, intracranial hematoma, or neurosurgery) ranged from 0.0% to 8.3%. A random-effects meta-analysis showed a weighted composite outcome risk of 3.7% (95% confidence interval 1.7% to 5.8%; I2=3.3%). The overall quality of the body of evidence was low as a result of imprecision, indirectness, and risk of bias. CONCLUSION: There are limited data available to characterize the risk of adverse outcome in patients receiving direct oral anticoagulants after mild traumatic brain injury. A sufficiently powered prospective cohort study is required to validly define this risk, identify clinical features predictive of adverse outcome, and inform future head injury guidelines.
STUDY OBJECTIVE:Patients receiving direct oral anticoagulant medications commonly undergo computed tomography head scanning after mild traumatic brain injury, regardless of symptoms or signs. International guidelines have noted a lack of evidence to support management decisions for such patients. This systematic review aims to identify, appraise, and synthesize the current evidence for the risk of adverse outcome in patients receiving direct oral anticoagulants after mild head injury. METHODS: A protocol was registered with PROSPERO and review methodology followed Cochrane Collaboration recommendations. Studies of adult patients with mild head injury (Glasgow Coma Scale score 13 to 15) and who were receiving direct oral anticoagulants that reported the risk of adverse outcome after the head injury were eligible for inclusion. A comprehensive range of bibliographic databases and gray literature was examined with a sensitive search strategy. Selection of eligible studies, data extraction, and risk of bias were evaluated independently by separate reviewers. A random-effects meta-analysis was used to provide a pooled estimate of the risk of adverse outcome. The overall quality of evidence was assessed with the Grading of Recommendations Assessment, Development and Evaluation Working Group approach. RESULTS: A total of 4,886 articles were screened for inclusion, of which 7 cohort studies including 346 patients met inclusion criteria. All studies were at high or unclear risk of bias as a result of selection and information bias. Estimates of adverse outcome (any death, intracranial hematoma, or neurosurgery) ranged from 0.0% to 8.3%. A random-effects meta-analysis showed a weighted composite outcome risk of 3.7% (95% confidence interval 1.7% to 5.8%; I2=3.3%). The overall quality of the body of evidence was low as a result of imprecision, indirectness, and risk of bias. CONCLUSION: There are limited data available to characterize the risk of adverse outcome in patients receiving direct oral anticoagulants after mild traumatic brain injury. A sufficiently powered prospective cohort study is required to validly define this risk, identify clinical features predictive of adverse outcome, and inform future head injury guidelines.