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Sökning: WFRF:(Hull Roger)

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1.
  • Hull, Russell D., et al. (författare)
  • Benefit-to-harm ratio of thromboprophylaxis for patients undergoing major orthopaedic surgery
  • 2014
  • Ingår i: Thrombosis and Haemostasis. - 0340-6245 .- 2567-689X. ; 111:2, s. 199-212
  • Tidskriftsartikel (refereegranskat)abstract
    • Surgeons consider the benefit-to-harm ratio when making decisions regarding the use of anticoagulant venous thromboembolism (VIE) prophylaxis. We evaluated the benefit-to-harm ratio of the use of newer anticoagulants as thromboprophylaxis in patients undergoing major orthopaedic surgery using the likelihood of being helped or harmed (LHH), and assessed the effects of variation in the definition of major bleeding on the results. A systematic literature search was performed to identify phase II and phase III studies that compared regulatory authority-approved newer anticoagulants to the low-molecular-weight heparin enoxaparin in patients undergoing major orthopaedic surgery. Analysis of outcomes data estimated the clinical benefit (number-needed-to-treat [NNT] to prevent one symptomatic VIE) and clinical harm (number-needed-to-harm [NNH] or the NNT to cause one major bleeding event) of therapies. We estimated each trial's benefit, to-harm ratio from NNT and NNH values, and expressed this as LHH = (1/NNT)/(1/NNH) = NNH/NNT, Based on reporting of efficacy and safety outcomes, most studies favoured enoxaparin over fondaparinux, and rivaroxaban over enoxaparin. However, when using the LHH metric, most trials favoured enoxaparin over both fondaparinux and rivaroxaban when they included surgical-site bleeding that did not require reoperation in the definition of major bleeding. The exclusion of bleeding at surgical site which did not require reoperation shifted the benefit-to-harm ratio in favour of the newer agents. Variations in the definitions of major bleeding may change the benefit-to-harm ratio and subsequently affect its interpretation. Clinical trials should attempt to improve the consistency of major bleeding reporting.
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2.
  • Hull, Russell D., et al. (författare)
  • State-of-the-art review : Assessing the safety profiles of new anticoagulants for major orthopedic surgery thromboprophylaxis
  • 2009
  • Ingår i: Clinical and applied thrombosis/hemostasis. - : SAGE Publications. - 1076-0296 .- 1938-2723. ; 15:4, s. 377-388
  • Forskningsöversikt (refereegranskat)abstract
    • BACKGROUND: The safety and efficacy of new anticoagulants are often initially tested for venous thromboembolism (VTE) prevention in patients undergoing major orthopedic surgery. Concern among surgeons about the risks for bleeding may result in suboptimal use of thrombophylaxis. OBJECTIVE: To evaluate the definitions used to define bleeding outcomes in studies of new anticoagulants and to examine the influence the definition has on the perceived bleeding risk of thromboprophylaxis. METHODS: The MedLine database was searched for phase III studies of new anticoagulants versus the standard comparator, enoxaparin, in patients undergoing major orthopedic surgery. RESULTS: The definitions for major bleeding outcomes varied widely both across and within clinical trial programs of new anticoagulants. Studies which did not include surgical site bleeding in their definition for major bleeding showed lower major bleeding rates in comparison to those that did include this outcome. Other factors that influenced the rate of major bleeding included the timing of prophylaxis initiation in relation to surgery and the dose of anticoagulant therapy. The wide range of definitions used for major bleeding made it difficult to compare bleeding risk among studies of new anticoagulants. CONCLUSIONS: The definitions of bleeding events that clinical trials of thromboprophylaxis use in their assessment of new anticoagulants strongly influences each drug's perceived safety profile and may underestimate bleeding risks. Clinical studies of new anticoagulants urgently need standardization of bleeding definitions to allow intertrial comparability and to ensure consistent reporting of clinically relevant outcomes.
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