Browsing by Author "Neumann, Ignacio"

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    International Society on Thrombosis and Haemostasis clinical practice guideline for treatment of congenital hemophilia A and B based on the Grading of Recommendations Assessment, Development, and Evaluation methodology
    (2024) Rezende, Suely; Neumann, Ignacio; Angchaisuksiri, Pantep; Awodu, Omolade; Boban, Ana; Cuker, Adam; Curtin, Julie; Fijnvandraat, Karin; Gouw, Samantha; Gualtierotti, Roberta; Makris, Michael; Nahuelhual, Paula; O'Connell, Niamh; Saxena, Renu; Shima, Midori; Wu, Runhui; Rosendaal, Frits
    Background: Hemophilia is a rare congenital bleeding disorder that results from complete or partial deficiency of blood coagulation factor (F)VIII (hemophilia A) or FIX (hemophilia B) due to pathogenic variants in their coding genes. Hemophilia requires complex management. To date, there is no evidence-based clinical practice guideline on hemophilia treatment based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Objectives: This evidence-based clinical practice guideline from the International Society on Thrombosis and Haemostasis aims to provide an overview of evidence and support patients, caregivers, hematologists, pediatricians, other clinicians, researchers, and stakeholders in treatment decisions about congenital hemophilia A and B. Methods: The International Society on Thrombosis and Haemostasis formed a multidisciplinary guideline panel of physicians and patients with global representation, balanced to minimize potential bias from conflicts of interest. The panel prioritized a set of clinical questions and outcomes according to their importance for clinicians and patients. A methodological team supported the guideline development process, including searching for evidence and performing systematic reviews. The GRADE approach was used, including GRADE Evidence to Decision frameworks. The recommendations were subject to public comment. Results: The panel selected 13 questions, of which 11 addressed the treatment of hemophilia A and 2 the treatment of hemophilia B. Specifically, the panel addressed questions on prophylactic and episodic treatment with FVIII concentrates, bypassing agents, and nonfactor therapy (emicizumab) for hemophilia A (with and without inhibitors) as well as immune tolerance induction for hemophilia A. For hemophilia B, the panel addressed questions on prophylactic and episodic treatment of bleeding events with FIX concentrates. Agreement was reached for all 13 recommendations, of which 7 (54%) were based on evidence from randomized clinical trials, 3 (23%) on observational studies, and 3 (23%) on indirect comparisons. Conclusion: Strong recommendations were issued for prophylactic over episodic treatment for severe and moderately severe hemophilia A and B. Only conditional recommendations were issued for the remaining questions. Future research should focus on direct treatment comparisons and the treatment of hemophilia B with and without inhibitors. Future updates of this guideline will provide an updated evidence synthesis on the current questions and focus on new FVIII and FIX concentrates, novel nonfactor therapies, and gene therapy for severe and nonsevere hemophilia A and B.
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    Low anonymous voting compliance with the novel policy for managing conflicts of interest implemented in the 9th version of the american college of chest physicians antithrombotic guidelines
    (Elsevier, 2013) Neumann, Ignacio; Akl, Elie; Valdes, Macarena; Bravo, Stephanie; Araos, Silvana; Kairouz, Kairouz; Schünemann, Holger; Guyatt, Gordon;
    BACKGROUND: The executive committee of the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (AT9) developed a strategy to limit the impact of conflict of interest (COI) on recommendations. This policy excluded conflicted panelists from voting on recommendations with which they had conflicts. The objective of the study is to explore the compliance of the attendees of the AT9 final conference. METHODS: We conducted a survey and reviewed public declarations of COI of all the final AT9 conference attendees. For each of the controversies on which voting occurred (nine of 628 total recommendations), we estimated the compliance with COI policy as the proportion of attendees who recused themselves from voting on controversies for which they were conflicted. To evaluate the potential effect of noncompliance, we assumed that every vote cast by an ineligible conference attendee was cast in direction of the majority vote. RESULTS: Sixty-three panelists voted in at least one controversy at the final conference; the percentage of conflicted panelists varied from 6% to 39% for eight controversies. The compliance with the COI policy was 14 of 14 (100%) for one controversy, and varied from one of 19 (5%) to one of three (33%) in the remaining seven. In two of the eight controversies ("Compression device plus aspirin vs low-molecular-weight heparin in tromboprophylaxis in orthopedic surgery" and "Low-molecular-weight heparin vs vitamin K antagonists for treatment"), the low compliance may have affected the final recommendations. CONCLUSIONS: The low compliance raises concerns about implementation of COI restrictions in the context of anonymous voting.

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