162 results on '"Siegal, D."'
Search Results
2. IMPACT OF ANTICOAGULANTS FOR ARTERIAL THROMBOEMBOLISM PREVENTION AMONG AMBULATORY CANCER PATIENTS BY PRIMARY TUMOUR SITE: SYSTEMATIC REVIEW AND META-ANALYSIS
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Mallity, C., primary, Collins, E., additional, Siegal, D., additional, Wang, T., additional, Carrier, M., additional, and Xu, Y., additional
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- 2023
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3. PB0014 Do Antiphospholipid Antibodies Inform the Choice of Anticoagulant Agents in Patients with Atrial Fibrillation?
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Bikdeli, B., primary, Bejjani, A., additional, Khairani, C., additional, Jimenez, D., additional, Monreal, M., additional, Siegal, D., additional, Kanthi, Y., additional, Barnes, G., additional, O’Donoghue, M., additional, Ruff, C., additional, Middeldorp, S., additional, Lopes, R., additional, Goldhaber, S., additional, Weitz, J., additional, Cushman, M., additional, Krumholz, H., additional, Lip, G., additional, and Piazza, G., additional
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- 2023
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4. OC 31.1 Management and Outcomes of Anticoagulated Patients in Urgent Surgery: The PAUSE-ER Study
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Siegal, D., primary, Arnaoutoglou, E., additional, Blostein, M., additional, Castellucci, L., additional, Eikelboom, J., additional, Gandhi, R., additional, Gross, P., additional, Kaatz, S., additional, Le Gal, G., additional, Schulman, S., additional, Shah, V., additional, Stamoulis, K., additional, Tafur, A., additional, Vogt, K., additional, Nixon, J., additional, St John, M., additional, Karunakaran, M., additional, Levoy-Jones, B., additional, and Douketis, J., additional
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- 2023
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5. PB1312 “The Doctor Says So” - Patient Values and Preferences Regarding Resumption of Oral Anticoagulation after Gastrointestinal Bleeding
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Awada, N., primary, Chien, K., additional, Little, D., additional, Carrier, M., additional, Deal, K., additional, Dionne, J., additional, Douketis, J., additional, Forbes, N., additional, Holbrook, A., additional, Ostrowski, M., additional, Robertson, T., additional, Stacey, D., additional, West, C., additional, Xenodemetropoulos, T., additional, Xie, F., additional, and Siegal, D., additional
- Published
- 2023
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6. DIRECT ORAL ANTICOAGULANTS VERSUS VITAMIN K ANTAGONISTS IN THE FIRST 3 MONTHS AFTER BIOPROSTHETIC VALVE REPLACEMENT: A SYSTEMATIC REVIEW AND META-ANALYSIS
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Eikelboom, R., primary, Siegal, D., additional, Schulman, S., additional, Whitlock, R., additional, and Belley-Cote, E., additional
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- 2022
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7. Supplement to: Andexanet alfa for the reversal of factor Xa inhibitor activity.
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Siegal, D M, Curnutte, J T, and Connolly, S J
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- 2015
8. IMPACT OF ANTICOAGULANTS FOR ARTERIAL THROMBOEMBOLISM PREVENTION AMONG AMBULATORY CANCER PATIENTS BY PRIMARY TUMOUR SITE: SYSTEMATIC REVIEW AND META-ANALYSIS
- Author
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Mallity, C., Collins, E., Siegal, D., Wang, T., Carrier, M., and Xu, Y.
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- 2023
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9. ShearWave elastography: repeatability for measurement of tendon stiffness
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Peltz, C. D., Haladik, J. A., Divine, G., Siegal, D., van Holsbeeck, M., and Bey, M. J.
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- 2013
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10. ANTICOAGULANT THERAPY AND BLEEDING: THE PATIENT PERSPECTIVE
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Siegal, D., Cameron, L., Kenney, K., Kerzner, R., Monzavi-Bacon, S., and Wan, T.
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- 2023
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11. Graft-versus-host disease following marrow transplantation for aplastic anemia: different impact of two GVHD prevention strategies
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Siegal, D, Xu, W, Sutherland, R, Kamel-Reid, S, Kuruvilla, J, Lipton, J H, Minden, M, Messner, H, and Gupta, V
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- 2008
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12. Invasive pneumococcal disease in adult hematopoietic stem cell transplant recipients: a decade of prospective population-based surveillance
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Kumar, D, Humar, A, Plevneshi, A, Siegal, D, Franke, N, Green, K, and McGeer, A
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- 2008
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13. Invasive Pneumococcal Disease in Solid Organ Transplant Recipients—10-Year Prospective Population Surveillance
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Kumar, D., Humar, A., Plevneshi, A., Green, K., Prasad, G.V.R., Siegal, D., and McGeer, A.
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- 2007
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14. Establishing diagnostic criteria and treatment of subsegmental pulmonary embolism: A Delphi analysis of experts
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Exter, P.L. den, Kroft, L.J., Gonsalves, C., Gal, G. Le, Schaefer-Prokop, C.M., Carrier, M., Huisman, M.V., Klok, F.A., Meijboom, L., Beenen, L.F., Roos, A, Hartmann, I., Dennie, C., Revel, M.P., Haramati, L., Beek, E. van, Screaton, N., Ferretti, G., Ghaye, B., Das, M., White, C., Fernandez, E. Pena, Paul, N., Vlahos, I., Renapurkar, R.D., Ravenel, J., Kanne, J., Abbara, S., Remy-Jardin, M., Geurts, B., Frauenfelder, T., Sverzellati, N., Prosch, H., Goo, J.M., Vogel-Claussen, J., MacMahon, P.J., Bhalla, S., Kahn, S., Shivakumar, S., Wells, P., Rodger, M., Castellucci, L., Duffett, L., Delluc, A., Siegal, D., Lazo-Langner, A., Wu, C., Lee, A, Garcia, D., Zwicker, J., Aujesky, D., Jimenez, D., Righini, M., Blondon, M., Ay, C., Barco, S., Kamphuisen, P.W., Ferreira, M., Sanchez, O., Moores, L.K., Tromeur, C., Ageno, W., Hunt, B., Prandoni, P., Monreal, M., Crowther, M., Roy, P.M., Pabinger, I., Donadini, M.P., Moustafa, F., Jara-Palomares, L., Pedroc, R., Bertoletti, L., Verhamme, P., Eikenboom, H., Meer, F. van der, Buller, H.R., Es, N. van, Exter, P.L. den, Kroft, L.J., Gonsalves, C., Gal, G. Le, Schaefer-Prokop, C.M., Carrier, M., Huisman, M.V., Klok, F.A., Meijboom, L., Beenen, L.F., Roos, A, Hartmann, I., Dennie, C., Revel, M.P., Haramati, L., Beek, E. van, Screaton, N., Ferretti, G., Ghaye, B., Das, M., White, C., Fernandez, E. Pena, Paul, N., Vlahos, I., Renapurkar, R.D., Ravenel, J., Kanne, J., Abbara, S., Remy-Jardin, M., Geurts, B., Frauenfelder, T., Sverzellati, N., Prosch, H., Goo, J.M., Vogel-Claussen, J., MacMahon, P.J., Bhalla, S., Kahn, S., Shivakumar, S., Wells, P., Rodger, M., Castellucci, L., Duffett, L., Delluc, A., Siegal, D., Lazo-Langner, A., Wu, C., Lee, A, Garcia, D., Zwicker, J., Aujesky, D., Jimenez, D., Righini, M., Blondon, M., Ay, C., Barco, S., Kamphuisen, P.W., Ferreira, M., Sanchez, O., Moores, L.K., Tromeur, C., Ageno, W., Hunt, B., Prandoni, P., Monreal, M., Crowther, M., Roy, P.M., Pabinger, I., Donadini, M.P., Moustafa, F., Jara-Palomares, L., Pedroc, R., Bertoletti, L., Verhamme, P., Eikenboom, H., Meer, F. van der, Buller, H.R., and Es, N. van
- Abstract
Contains fulltext : 229597.pdf (publisher's version ) (Open Access), Background: Improved imaging techniques have increased the incidence of subsegmental pulmonary embolism (ssPE). Indirect evidence is suggesting that ssPE may represent a more benign presentation of venous thromboembolism not necessarily requiring anticoagulant treatment. However, correctly diagnosing ssPE is challenging with reported low interobserver agreement, partly due to the lack of widely accepted diagnostic criteria. Objectives: We sought to derive uniform diagnostic criteria for ssPE, guided by expert consensus. Methods: Based on an extensive literature review and expert opinion of a Delphi steering committee, two surveys including statements regarding diagnostic criteria and management options for ssPE were established. These surveys were conducted electronically among two panels, respectively: expert thoracic radiologists and clinical venous thromboembolism specialists. The Delphi method was used to achieve consensus after multiple survey rounds. Consensus was defined as a level of agreement >70%. Results: Twenty-nine of 40 invited radiologists (73%) and 40 of 51 clinicians (78%) participated. Following two survey rounds by the expert radiologists, consensus was achieved on 15 of 16 statements, including on the established diagnostic criteria for ssPE (96% agreement): a contrast defect in a subsegmental artery, that is, the first arterial branch division of any segmental artery independent of artery diameter, visible in at least two subsequent axial slices, using a computed tomography scanner with a desired maximum collimator width of =1 mm. These criteria were approved by 83% of the clinical venous thromboembolism (VTE) specialists. The clinical expert panel favored anticoagulant treatment in case of prior VTE, antiphospholipid syndrome, pregnancy, cancer, and proximal deep vein thrombosis. Conclusion: The results of this analysis provide standard radiological criteria for ssPE that may be applicable in both clinical trials and practice.
- Published
- 2020
15. Efficacy and safety of weight-adjusted extended duration tinzaparin for prevention of post-operative venous thromboembolism after bariatric surgery: PB 3.46–3
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Siegal, D M, Handa, P, Crowther, M, Douketis, J D, Anvari, M, and Tiboni, M
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- 2013
16. Anticoagulants in cancer
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SIEGAL, D. M. and GARCIA, D.
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- 2012
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17. A146 MANAGEMENT OF ANTITHROMBOTIC THERAPY AFTER GASTROINTESTINAL BLEEDING: A MIXED METHODS STUDY OF HEALTHCARE PROVIDERS
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Little, D H, primary, Pinto, T, primary, Douketis, J, primary, Dionne, J, primary, Holbrook, A, primary, Xenodemetropoulos, T, primary, and Siegal, D, primary
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- 2020
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18. Immunogenicity of Pneumococcal Vaccine in Renal Transplant Recipients—Three Year Follow-up of a Randomized Trial
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Kumar, D., Welsh, B., Siegal, D., Chen, M. Hong, and Humar, A.
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- 2007
19. P6. Abstract Title: Risks and Benefits of Antithrombotic Therapy in Polycythemia Vera: A Systematic Review
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Laureano, M., primary, Goodlife, L., additional, Chu, D., additional, and Siegal, D., additional
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- 2019
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20. Reducing Unnecessary Blood Tests in the Critically Ill (RUBIC): A Multi-Center Prospective Audit
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Khalifa, A., primary, Dodek, P.M., additional, Hillis, C., additional, Garland, A., additional, Duan, E., additional, Belley-Cote, E., additional, Kavsak, P., additional, Karachi, T.A., additional, Siegal, D., additional, Millen, T., additional, Heels-Ansdell, D., additional, Rahman, O., additional, Born, K., additional, English, S.W., additional, McCredie, V.A., additional, Charbonney, E., additional, Mbuagbaw, L., additional, Scales, D.C., additional, Bagshaw, S.M., additional, Amaral, A., additional, Meade, M.O., additional, Cook, D.J., additional, and Rochwerg, B., additional
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- 2019
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21. Why do clinicians withhold anticoagulation in patients with atrial fibrillation and CHA2DS2-VASc score ≥ 2?
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Martin, A., primary, Siegal, D., additional, Verbrugge, F., additional, Fiarresga, A., additional, Camm, J., additional, Pieper, K., additional, Fox, K.K.A., additional, Bassand, J.P., additional, Haas, S., additional, Goldhaber, S.Z., additional, and Kakkar, A.K., additional
- Published
- 2019
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22. Why do clinicians prescribe oral anticoagulation in patients with atrial fibrillation despite a low CHA2DS2-VASc score?
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Martin, A., primary, Verbrugge, F., additional, Siegal, D., additional, Fiarresga, A., additional, Pieper, K., additional, Camm, J., additional, Fox, K.K.A., additional, Bassand, J.P., additional, Haas, S., additional, Goldhaber, S.Z., additional, and Kakkar, A.K., additional
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- 2019
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23. Liver-Kidney Transplantation in Primary Hyperoxaluria Type-1: Case Report and Literature Review
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Siegal, D., Su, W. S., DaBreo, D., Puglia, M., Gregor, L., and Gangji, A. S.
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liver transplantation ,lcsh:R ,lcsh:Medicine ,Case Report ,renal transplantation ,Primary hyperoxaluria - Abstract
Primary hyperoxaluria type-1 (PH1) is a rare inherited autosomal recessive disorder in which a deficiency of the hepatic enzyme alanine-glyoxylate aminotransferase leads to endogenous oxalate overproduction, renal failure, systemic oxalate deposition and death. As hemodialysis provides insufficient oxalate clearance, patients ultimately require both liver and kidney transplantation for correction of the metabolic abnormality and oxalate excretion. Herein, we describe a young adult male with end-stage renal disease and systemic oxalosis causing progressive disabling multi-organ dysfunction while awaiting transplantation. We review the literature regarding liver-kidney transplantation and suggest that for patients with PH1, a standardized assessment of organ dysfunction and functional impairment may improve identification of patients requiring urgent transplantation thereby reducing the morbidity and mortality that can occur with delayed transplantation.
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- 2011
24. A Randomized, Double-Blind Trial of Pneumococcal Vaccination in Adult Allogeneic Stem Cell Transplant Donors and Recipients
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Kumar, D., primary, Chen, M. H., additional, Welsh, B., additional, Siegal, D., additional, Cobos, I., additional, Messner, H. A., additional, Lipton, J., additional, and Humar, A., additional
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- 2007
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25. 241: Neurological complications in the recipients of allogeneic hematopoietic cell transplant
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Siegal, D., primary, Keller, A., additional, Xu, W., additional, Bhuta, S., additional, Loach, D., additional, Kim, D., additional, Walia, J., additional, Kuruvilla, J., additional, Lipton, J., additional, Minden, M., additional, Messner, H., additional, and Gupta, V., additional
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- 2007
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26. Periprocedural heparin bridging in patients receiving vitamin k antagonists: systematic review and meta-analysis of bleeding and thromboembolic rates.
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Siegal D, Yudin J, Kaatz S, Douketis JD, Lim W, and Spyropoulos AC
- Abstract
BACKGROUND: Periprocedural bridging with unfractionated heparin or low-molecular-weight heparin aims to reduce the risk of thromboembolic events in patients receiving long-term vitamin K antagonists. Optimal periprocedural anticoagulation has not been established. METHODS AND RESULTS: MEDLINE, EMBASE, and Cochrane databases (2001-2010) were searched for English-language studies including patients receiving heparin bridging during interruption of vitamin K antagonists for elective procedures. Data were independently collected by 2 investigators ([kappa]=0.90). The final review included 34 studies with 1 randomized trial. Thromboembolic events occurred in 73 of 7118 bridged patients (pooled incidence, 0.9%; 95% confidence interval [CI], 0.0.0-3.4) and 32 of 5160 nonbridged patients (pooled incidence, 0.6%; 95% CI, 0.0-1.2). There was no difference in the risk of thromboembolic events in 8 studies comparing bridged and nonbridged groups (odds ratio, 0.80; 95% CI, 0.42-1.54). Bridging was associated with an increased risk of overall bleeding in 13 studies (odds ratio, 5.40; 95% CI, 3.00-9.74) and major bleeding in 5 studies (odds ratio, 3.60; 95% CI, 1.52-8.50) comparing bridged and nonbridged patients. There was no difference in thromboembolic events (odds ratio, 0.30; 95% CI, 0.04-2.09) but an increased risk of overall bleeding (odds ratio, 2.28; 95% CI, 1.27-4.08) with full versus prophylactic/intermediate-dose low-molecular-weight heparin bridging. Low-thromboembolic-risk and/or non-vitamin K antagonist patient groups were used for comparison. Study quality was poor with heterogeneity for some analyses. CONCLUSIONS: Vitamin K antagonist-treated patients receiving periprocedural heparin bridging appear to be at increased risk of overall and major bleeding and at similar risk of thromboembolic events compared to nonbridged patients. Randomized trials are needed to define the role of periprocedural heparin bridging. [ABSTRACT FROM AUTHOR]
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- 2012
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27. Why do clinicians withhold anticoagulation in patients with atrial fibrillation and CHA2DS2VASc score of 2 or higher?
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Kakkar, A. K., Goldhaber, S. Z., Haas, S., Bassand, J. P., Fox, K. A. A., Pieper, K., Camm, J., Fiarresga, A., Martin, A. C., Frederik Verbrugge, and Siegal, D. M.
28. Why do clinicians prescribe oral anticoagulation in patients with atrial fibrillation despite a low CHA2DS2-VASc score?
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Kakkar, A. K., Goldhaber, S. Z., Haas, S., Bassand, J. -P, Fox, K. A. A., Camm, J., Pieper, K., Fiarresga, A., Siegal, D., Martin, A. -C, Frederik Verbrugge, Clinical sciences, Medicine and Pharmacy academic/administration, Cardiology, and Intensive Care
- Subjects
prescription ,Atrial Fibrillation ,Oral Anticoagulation ,Cardiology and Cardiovascular Medicine
29. Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors.
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Connolly, S. J., Eikelboom, J. W., Siegal, D. M., Zotova, E., Meeks, B., Ahmad, S., Nakamya, J., Albaladejo, P., Lopez-Sendon, J., Demchuk, A. M., Pallin, D. J., Milling Jr., T. J., Crowther, M., Concha, M., Gibson, C. M., Curnutte, J. T., Lawrence, J. H., Yue, P., Bronson, M. D., and Lu, G.
- Subjects
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ENOXAPARIN , *THERAPEUTICS , *RECOMBINANT proteins , *BLOOD coagulation factors , *ANTICOAGULANTS , *ATRIAL fibrillation , *CEREBRAL hemorrhage , *COMPARATIVE studies , *GASTROINTESTINAL hemorrhage , *HEMORRHAGE , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *RESEARCH funding , *EVALUATION research , *RECEIVER operating characteristic curves , *ACUTE diseases ,BLOOD coagulants - Abstract
Background: Andexanet alfa is a modified recombinant inactive form of human factor Xa developed for reversal of factor Xa inhibitors.Methods: We evaluated 352 patients who had acute major bleeding within 18 hours after administration of a factor Xa inhibitor. The patients received a bolus of andexanet, followed by a 2-hour infusion. The coprimary outcomes were the percent change in anti-factor Xa activity after andexanet treatment and the percentage of patients with excellent or good hemostatic efficacy at 12 hours after the end of the infusion, with hemostatic efficacy adjudicated on the basis of prespecified criteria. Efficacy was assessed in the subgroup of patients with confirmed major bleeding and baseline anti-factor Xa activity of at least 75 ng per milliliter (or ≥0.25 IU per milliliter for those receiving enoxaparin).Results: Patients had a mean age of 77 years, and most had substantial cardiovascular disease. Bleeding was predominantly intracranial (in 227 patients [64%]) or gastrointestinal (in 90 patients [26%]). In patients who had received apixaban, the median anti-factor Xa activity decreased from 149.7 ng per milliliter at baseline to 11.1 ng per milliliter after the andexanet bolus (92% reduction; 95% confidence interval [CI], 91 to 93); in patients who had received rivaroxaban, the median value decreased from 211.8 ng per milliliter to 14.2 ng per milliliter (92% reduction; 95% CI, 88 to 94). Excellent or good hemostasis occurred in 204 of 249 patients (82%) who could be evaluated. Within 30 days, death occurred in 49 patients (14%) and a thrombotic event in 34 (10%). Reduction in anti-factor Xa activity was not predictive of hemostatic efficacy overall but was modestly predictive in patients with intracranial hemorrhage.Conclusions: In patients with acute major bleeding associated with the use of a factor Xa inhibitor, treatment with andexanet markedly reduced anti-factor Xa activity, and 82% of patients had excellent or good hemostatic efficacy at 12 hours, as adjudicated according to prespecified criteria. (Funded by Portola Pharmaceuticals; ANNEXA-4 ClinicalTrials.gov number, NCT02329327.). [ABSTRACT FROM AUTHOR]- Published
- 2019
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30. Venous Thromboembolism in Patients with Liver Cirrhosis: Findings from the RIETE (Registro Informatizado de la Enfermedad TromboEmbolica) Registry
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Antonella Tufano, María del Carmen Díaz-Pedroche, Gregory Y.H. Lip, Behnood Bikdeli, David Jiménez, Lucia Mazzolai, Carme Font, Derek H W Little, Riete Investigators, Guadalupe Garcia-Tsao, Raquel Barba, Deborah M. Siegal, Alfonso Tafur, Manuel Monreal, Bikdeli, B., Jimenez, D., Garcia-Tsao, G., Barba, R., Font, C., Diaz-Pedroche, M. D. C., Mazzolai, L., Little, D. H. W., Tufano, A., Tafur, A. J., Siegal, D., Lip, G. Y. H., and Monreal, M.
- Subjects
Registrie ,Liver Cirrhosis ,Male ,medicine.medical_specialty ,Cirrhosis ,Liver Cirrhosi ,venous thromboembolism ,030204 cardiovascular system & hematology ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Interquartile range ,Internal medicine ,medicine ,Humans ,Registries ,Aged ,business.industry ,cirrhosis ,Hazard ratio ,Venous Thromboembolism ,Hematology ,Odds ratio ,bleeding ,medicine.disease ,Comorbidity ,Confidence interval ,Pulmonary embolism ,Female ,Cardiology and Cardiovascular Medicine ,business ,Venous thromboembolism ,cirrhosi ,Human ,030215 immunology - Abstract
Patients with cirrhosis are not only at an increased risk of bleeding but also at risk of venous thromboembolism (VTE). We sought to determine the clinical characteristics, management, and outcomes after VTE in patients with cirrhosis. We used the data from RIETE (Registro Informatizado de la Enfermedad TromboEmbolica), an international registry of patients with VTE, to compare the outcomes in patients with and without cirrhosis. Main outcomes included all-cause mortality, pulmonary embolism (PE)-related mortality, recurrent VTE, and bleeding. Among 43,611 patients with acute VTE, 187 (0.4%) had cirrhosis. Of these, 184 (98.4%) received anticoagulation for a median of 109 days (interquartile range [IQR]: 43–201 days), most commonly with enoxaparin (median dose: 1.77 [IQR: 1.38–2.00] mg/kg/day). Compared with patients without cirrhosis, those with cirrhosis had a higher rate of all-cause mortality (10.7 vs. 3.4%; odds ratio [OR]: 3.41; 95% confidence interval [CI]: 2.03–5.46) and fatal bleeding (2.1 vs. 0.2%; OR: 13.94; 95% CI: 3.65–37.90) but similar rates of fatal PE (0.5 vs. 0.5%; OR: 1.17; 95% CI: 0.03–6.70). Patients with cirrhosis had a higher rate of all-cause mortality per 100 patient-years of follow-up (58.9 vs. 16.0; hazard ratio [HR]: 3.70; 95% CI: 2.69–4.91). One-year hazard ratio of clinically relevant bleeding (HR: 2.86; 95% CI: 1.91–4.27), fatal bleeding (HR: 8.51; 95% CI: 3.5–20.7), or recurrent VTE (HR: 2.08; 95% CI: 1.00–4.36) was higher in patients with cirrhosis. Cirrhosis is a challenging comorbidity in patients with VTE. Most patients were treated with anticoagulation and had an elevated risk of recurrence, similar risk of fatal PE, and a very high risk of bleeding including fatal bleeds.
- Published
- 2019
31. Reversal of direct oral anticoagulants: guidance from the SSC of the ISTH.
- Author
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Levy JH, Shaw JR, Castellucci LA, Connors JM, Douketis J, Lindhoff-Last E, Rocca B, Samama CM, Siegal D, and Weitz JI
- Subjects
- Humans, Administration, Oral, Recombinant Proteins therapeutic use, Recombinant Proteins administration & dosage, Anticoagulants adverse effects, Anticoagulants administration & dosage, Anticoagulants therapeutic use, Dabigatran administration & dosage, Dabigatran adverse effects, Factor Xa therapeutic use, Risk Factors, Treatment Outcome, Arginine analogs & derivatives, Piperazines, Hemorrhage chemically induced, Factor Xa Inhibitors adverse effects, Factor Xa Inhibitors administration & dosage, Factor Xa Inhibitors therapeutic use, Blood Coagulation drug effects, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized administration & dosage
- Abstract
The currently approved direct oral anticoagulants (DOACs) are increasingly used in clinical practice. Although serious bleeding risks are lower with DOACs than with vitamin K antagonists, bleeding remains the most frequent side effect. Andexanet alfa and idarucizumab are the currently approved specific reversal agents for oral factor (F)Xa inhibitors and dabigatran, respectively. Our prior guidance document was published in 2016, but with more information available on the utility and increased use of these reversal agents and other bleeding management strategies, we have updated this International Society on Thrombosis and Haemostasis guidance document on DOAC reversal. In this narrative review, we compare the mechanism of action of specific and nonspecific reversal agents, review the clinical data supporting their use, and provide guidance on when reversal is indicated. In addition, we briefly discuss the reversal of oral FXIa inhibitors, a new class of DOACs currently under clinical development., Competing Interests: Declaration of competing interests J.H.L.: Participation on Advisory or Steering Committees for Grifols, Octapharma, Takeda, and Werfen. J.R.S.: In-kind laboratory support from Diagnostica Stago. L.A.C.: L.A.C.’s research institution has received honoraria from Bayer, BMS-Pfizer Alliance, The Academy for Continued Advancement in Healthcare Education, Amag Pharmaceutical, LEO Pharma, Sanofi, Valeo Pharma, and Servier. L.A.C. holds a Tier 2 Research Chair from the University of Ottawa. J.M.C.: Participation on Scientific Advisory Boards and consulting for Abbott, Anthos, BMS, Pfizer, Roche, Sanofi, and Werfen; research funding from CSL Behring to the institution. J.D.: Serves on advisory committees for Pfizer, Sanofi, Leo Pharma, Bristol-Myers Squibb, and Janssen. E.L-L.: Lecture honoraria and advisory fees from Bayer AG, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo, Portola, CSL Behring, Norgine, Roche, Leo, AstraZeneca, and Aspen; institutional research support from Bayer AG, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo, Werfen, and CSL Behring. B.R.: Consultant for AbocaSRL on medical devices; Advisory Committee for Bayer AG. C.M.S.: Advisory for Norgine Pharma. D.S.: Honoraria for educational presentations and advisory fees paid indirectly to research institute from AstraZeneca, BMS-Pfizer, Roche, Servier. D.S. is supported by a Tier 2 Canada Research Chair in Anticoagulant Management of Cardiovascular Disease. J.I.W.: Consultant or member of Advisory Boards or Steering Committees for Anthos, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Johnson and Johnson, Merck, and Regeneron., (Copyright © 2024 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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32. Physician practice patterns on the use of inferior vena cava filters in venous thromboembolism.
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Ladak R, Sementilli M, Calandra J, Lazo-Langner A, Siegal D, Wang TF, Luo R, and Cervi AL
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- 2024
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33. A Canadian survey of perceptions and practices related to ordering of blood tests in the intensive care unit.
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Rahman MO, Charbonney E, Vaisler R, Khalifa A, Alhazzani W, Gossack-Keenan K, Garland A, Karachi T, Duan E, Bagshaw SM, Meade MO, Hillis C, Kavsak P, Born K, Mbuagbaw L, Siegal D, Millen T, Scales D, Amaral A, English S, McCredie VA, Dodek P, Cook DJ, and Rochwerg B
- Subjects
- Humans, Canada, Cross-Sectional Studies, Hematologic Tests statistics & numerical data, Attitude of Health Personnel, Adult, Surveys and Questionnaires, Male, Unnecessary Procedures statistics & numerical data, Critical Illness, Female, Critical Care statistics & numerical data, Intensive Care Units statistics & numerical data, Practice Patterns, Physicians' statistics & numerical data
- Abstract
Purpose: The ordering of routine blood test panels in advance is common in intensive care units (ICUs), with limited consideration of the pretest probability of finding abnormalities. This practice contributes to anemia, false positive results, and health care costs. We sought to understand practices and attitudes of Canadian adult intensivists regarding ordering of blood tests in critically ill patients., Methods: We conducted a nationwide Canadian cross-sectional survey consisting of 15 questions assessing three domains (global perceptions, test ordering, daily practice), plus 11 demographic questions. The target sample was one intensivist per adult ICU in Canada. We summarized responses using descriptive statistics and present data as mean with standard deviation (SD) or count with percentage as appropriate., Results: Over seven months, 80/131 (61%) physicians responded from 77 ICUs, 50% of which were from Ontario. Respondents had a mean (SD) clinical experience of 12 (9) years, and 61% worked in academic centres. When asked about their perceptions of how frequently unnecessary blood tests are ordered, 61% responded "sometimes" and 23% responded "almost always." Fifty-seven percent favoured ordering complete blood counts one day in advance. Only 24% of respondents believed that advanced blood test ordering frequently led to changes in management. The most common factors perceived to influence blood test ordering in the ICU were physician preferences, institutional patterns, and order sets., Conclusion: Most respondents to this survey perceived that unnecessary blood testing occurs in the ICU. The survey identified possible strategies to decrease the number of blood tests., (© 2024. Canadian Anesthesiologists' Society.)
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- 2024
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34. Small-volume blood sample collection tubes in adult intensive care units: A rapid practice guideline.
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Callum J, Putowski Z, Alhazzani W, Belley-Cote E, Møller MH, Curry N, Al Duhailib Z, Fung M, Giocobbo L, Granholm A, Louw V, Maybohm P, Muller M, Nielsen N, Oleschuk C, Raza S, Scruth E, Siegal D, Stanworth SJ, Vlaar APJ, White M, and Oczkowski S
- Abstract
Background: This Intensive Care Medicine Rapid Practice Guideline (ICM-RPG) provides an evidence-based recommendation to address the question: in adult patients in intensive care units (ICUs), should we use small-volume or conventional blood collection tubes?, Methods: We included 23 panelists in 8 countries and assessed and managed financial and intellectual conflicts of interest. Methodological support was provided by the Guidelines in Intensive Care, Development, and Evaluation (GUIDE) group. We conducted a systematic review, including evidence from observational and randomized studies. Using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach, we evaluated the certainty of evidence and developed recommendations using the Evidence-to-Decision framework., Results: We identified 8 studies (1 cluster and 2 patient-level randomized trials; 5 observational studies) comparing small-volume to conventional tubes. We had high certainty evidence that small-volume tubes reduce daily and cumulative blood sampling volume; and moderate certainty evidence that they reduce the risk of transfusion and mean number of red blood cell units transfused, but these estimates were limited by imprecision. We had high certainty that small-volume tubes have a similar rate of specimens with insufficient quantity. The panel considered that the desirable effects of small-volume tubes outweigh the undesirable effects, are less wasteful of resources, and are feasible, as demonstrated by successful implementation across multiple countries, although there are upfront implementation costs to validate small-volume tubes on laboratory instrumentation., Conclusion: This ICM-RPG panel made a strong recommendation for the use of small-volume sample collection tubes in adult ICUs based on overall moderate certainty evidence., (© 2024 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.)
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- 2024
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35. Incidence, Predictors, and Outcomes of Clinically Significant Post-ERCP Bleeding: a Contemporary Multi-center Study.
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Bishay K, Ruan Y, Barkun AN, Chen YI, Singh A, Hookey L, Arya N, Calo NC, Grover SC, Siersema PD, Thosani N, Darvish-Kazem S, Siegal D, Bass S, Cole M, Lei Y, Li S, Mohamed R, Turbide C, Chau M, Howarth M, Cartwright S, Koury HF, Nashad T, Meng ZW, Tepox-Padrón A, Kayal A, González-Moreno E, Brenner DR, Smith ZL, Keswani RN, Elmunzer BJ, Wani S, Bridges RJ, Hilsden RJ, Heitman SJ, and Forbes N
- Abstract
Background Aims: Clinically significant post-endoscopic retrograde cholangiopancreatography (ERCP) bleeding (CSPEB) is common. Contemporary estimates of risk are lacking. We aimed to identify risk factors for and outcomes following CSPEB., Methods: We analyzed multi-center prospective ERCP data between 2018-2023 with 30-day follow-up. The primary outcome was CSPEB, defined as hematemesis, melena, or hematochezia resulting in: hemoglobin drop ≥20 g/L or transfusion and/or endoscopy to evaluate suspected bleeding, and/or unplanned healthcare visitation and/or prolongation of existing admission. Firth logistic regression was employed. P-values <0.05 were significant, with odds ratios (ORs) and 95% confidence intervals reported., Results: CSPEB occurred following 129 (1.5%) of 8,517 ERCPs (mean onset 3.2 days), with 110 of 4,849 events (2.3%) occurring following higher-risk interventions (sphincterotomy, sphincteroplasty, pre-cut sphincterotomy, and/or needle-knife access). CSPEB patients required endoscopy and transfusion in 86.0% and 53.5% of cases, respectively, with three cases (2.3%) being fatal. P2Y12 inhibitors were held for a median of 4 days (IQR 4) prior to higher-risk ERCP. Following higher-risk interventions, P2Y12 inhibitors (OR 3.33, 1.26-7.74), warfarin (OR 8.54, 3.32-19.81), dabigatran (OR 13.40, 2.06-59.96), rivaroxaban (OR 7.42, 3.43-15.24) and apixaban (OR 4.16, 1.99-8.20) were associated with CSPEB. Significant intraprocedural bleeding post sphincterotomy (OR 2.32, 1.06-4.60), but not post sphincteroplasty, was also associated. Concomitant cardiorespiratory events occurred more frequently within 30 days following CSPEB (OR 12.71, 4.75-32.54)., Conclusions: Risks of antiplatelet-related CSPEB may be underestimated by endoscopists based on observations of suboptimal holding before higher-risk ERCP. Appropriate periprocedural antithrombotic management is essential and could represent novel quality initiative targets., (Copyright © 2024 by The American College of Gastroenterology.)
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- 2024
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36. Canadian Stroke Best Practice Recommendations, 7 th Edition: Cerebral Venous Thrombosis, 2024.
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Field TS, Lindsay MP, Wein T, Debicki DB, Gorman J, Heran MKS, Levin LA, Lund R, Moharir M, Peeling L, Perera KS, Siegal D, Verreault S, Foley N, Martin C, Smith EE, Mountain A, and Mandzia J
- Abstract
The 7
th edition of the Canadian Stroke Best Practice Recommendations (CSBPR) is a comprehensive summary of current evidence-based recommendations, appropriate for use by healthcare providers and system planners, and intended to drive healthcare excellence, improved outcomes and more integrated health systems. This edition includes a new module on the management of cerebral venous thrombosis (CVT). Cerebral venous thrombosis is defined as thrombosis of the veins of the brain, including the dural venous sinuses and/or cortical or deep veins. Cerebral venous thrombosis is a rare but potentially life-threatening type of stroke, representing 0.5-1.0% of all stroke admissions. The reported rates of CVT are approximately 10-20 per million and appear to be increasing over time. The risk of CVT is higher in women and often associated with oral contraceptive use and with pregnancy and the puerperium. This guideline addresses care for adult individuals who present to the healthcare system with current or recent symptoms of CVT. The recommendations cover the continuum of care from diagnosis and initial clinical assessment of symptomatic CVT, to acute treatment of symptomatic CVT, post-acute management, person-centered care, special considerations in the long-term management of CVT, including pregnancy and considerations related to CVT in special circumstances such as trauma and vaccination. This module also includes supporting materials such as implementation resources to facilitate the adoption of evidence into practice and performance measures to enable monitoring of uptake and effectiveness of recommendations.- Published
- 2024
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37. Coordination of oral anticoagulant care at hospital discharge (COACHeD): pilot randomised controlled trial.
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Holbrook A, Troyan S, Telford V, Koubaesh Y, Vidug K, Yoo L, Deng J, Lohit S, Giilck S, Ahmed A, Talman M, Leonard B, Refaei M, Tarride JE, Schulman S, Douketis J, Thabane L, Hyland S, Ho JM, and Siegal D
- Subjects
- Humans, Female, Male, Aged, Pilot Projects, Ontario, Middle Aged, Administration, Oral, Aged, 80 and over, Feasibility Studies, Quality of Life, Continuity of Patient Care, Anticoagulants administration & dosage, Anticoagulants therapeutic use, Anticoagulants adverse effects, Anticoagulants economics, Patient Discharge
- Abstract
Objectives: To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home., Design: Randomised, parallel design., Setting: Medical wards at six hospital sites in southern Ontario, Canada., Participants: Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks., Interventions: Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care., Outcomes Measures: Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation., Results: Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62))., Conclusion: This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial., Trial Registration Number: NCT02777047., Competing Interests: Competing interests: DMS has received honoraria paid indirectly to her research institute from AstraZeneca, BMS-Pfizer, Roche and Servier. DMS is supported by a Tier 2 Canada Research Chair in Anticoagulant Management of Cardiovascular Disease. The other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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38. Synthetic data in cancer and cerebrovascular disease research: A novel approach to big data.
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Lun R, Siegal D, Ramsay T, Stotts G, and Dowlatshahi D
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- Humans, Retrospective Studies, Big Data, Risk Factors, Stroke complications, Neoplasms epidemiology, Neoplasms complications, Ischemic Stroke complications, Pulmonary Disease, Chronic Obstructive complications
- Abstract
Objectives: Synthetic datasets are artificially manufactured based on real health systems data but do not contain real patient information. We sought to validate the use of synthetic data in stroke and cancer research by conducting a comparison study of cancer patients with ischemic stroke to non-cancer patients with ischemic stroke., Design: retrospective cohort study., Setting: We used synthetic data generated by MDClone and compared it to its original source data (i.e. real patient data from the Ottawa Hospital Data Warehouse)., Outcome Measures: We compared key differences in demographics, treatment characteristics, length of stay, and costs between cancer patients with ischemic stroke and non-cancer patients with ischemic stroke. We used a binary, multivariable logistic regression model to identify risk factors for recurrent stroke in the cancer population., Results: Using synthetic data, we found cancer patients with ischemic stroke had a lower prevalence of hypertension (52.0% in the cancer cohort vs 57.7% in the non-cancer cohort, p<0.0001), and a higher prevalence of chronic obstructive pulmonary disease (COPD: 8.5% vs 4.7%, p<0.0001), prior ischemic stroke (1.7% vs 0.1%, p<0.001), and prior venous thromboembolism (VTE: 8.2% vs 1.5%, p<0.0001). They also had a longer length of stay (8 days [IQR 3-16] vs 6 days [IQR 3-13], p = 0.011), and higher costs associated with their stroke encounters: $11,498 (IQR $4,440 -$20,668) in the cancer cohort vs $8,084 (IQR $3,947 -$16,706) in the non-cancer cohort (p = 0.0061). A multivariable logistic regression model identified 5 predictors for recurrent ischemic stroke in the cancer cohort using synthetic data; 3 of the same predictors identified using real patient data with similar effect measures. Summary statistics between synthetic and original datasets did not significantly differ, other than slight differences in the distributions of frequencies for numeric data., Conclusion: We demonstrated the utility of synthetic data in stroke and cancer research and provided key differences between cancer and non-cancer patients with ischemic stroke. Synthetic data is a powerful tool that can allow researchers to easily explore hypothesis generation, enable data sharing without privacy breaches, and ensure broad access to big data in a rapid, safe, and reliable fashion., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Lun et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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39. Burden of serious harms from diagnostic error in the USA.
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Newman-Toker DE, Nassery N, Schaffer AC, Yu-Moe CW, Clemens GD, Wang Z, Zhu Y, Saber Tehrani AS, Fanai M, Hassoon A, and Siegal D
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- Humans, United States epidemiology, Cross-Sectional Studies, Morbidity, Diagnostic Errors, Stroke, Lung Neoplasms
- Abstract
Background: Diagnostic errors cause substantial preventable harms worldwide, but rigorous estimates for total burden are lacking. We previously estimated diagnostic error and serious harm rates for key dangerous diseases in major disease categories and validated plausible ranges using clinical experts., Objective: We sought to estimate the annual US burden of serious misdiagnosis-related harms (permanent morbidity, mortality) by combining prior results with rigorous estimates of disease incidence., Methods: Cross-sectional analysis of US-based nationally representative observational data. We estimated annual incident vascular events and infections from 21.5 million (M) sampled US hospital discharges (2012-2014). Annual new cancers were taken from US-based registries (2014). Years were selected for coding consistency with prior literature. Disease-specific incidences for 15 major vascular events, infections and cancers ('Big Three' categories) were multiplied by literature-based rates to derive diagnostic errors and serious harms. We calculated uncertainty estimates using Monte Carlo simulations. Validity checks included sensitivity analyses and comparison with prior published estimates., Results: Annual US incidence was 6.0 M vascular events, 6.2 M infections and 1.5 M cancers. Per 'Big Three' dangerous disease case, weighted mean error and serious harm rates were 11.1% and 4.4%, respectively. Extrapolating to all diseases (including non-'Big Three' dangerous disease categories), we estimated total serious harms annually in the USA to be 795 000 (plausible range 598 000-1 023 000). Sensitivity analyses using more conservative assumptions estimated 549 000 serious harms. Results were compatible with setting-specific serious harm estimates from inpatient, emergency department and ambulatory care. The 15 dangerous diseases accounted for 50.7% of total serious harms and the top 5 (stroke, sepsis, pneumonia, venous thromboembolism and lung cancer) accounted for 38.7%., Conclusion: An estimated 795 000 Americans become permanently disabled or die annually across care settings because dangerous diseases are misdiagnosed. Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined., Competing Interests: Competing interests: DEN-T has a career focus and conducts research related to diagnostic errors, including in patients with dizziness and stroke. He serves as the principal investigator for multiple grants and contracts on these topics. DEN-T is a former volunteer President and member of the Board of Directors of the Society to Improve Diagnosis in Medicine. Johns Hopkins has been loaned research equipment (video-oculography (VOG) systems) by two companies for use in DEN-T’s research; one of these companies has also provided funding for DEN-T’s research on diagnostic algorithm development related to dizziness, inner ear diseases and stroke. DEN-T has no other financial interest in these or any other companies. DEN-T is an inventor on a provisional patent (US PCT/US2020/070304) for smartphone-based stroke diagnosis in patients with dizziness. He gives frequent academic lectures on these topics and occasionally serves as a medico-legal consultant for both plaintiff and defence in cases related to dizziness, stroke and diagnostic error. DS is also a former volunteer member of the Board of Directors of the Society to Improve Diagnosis in Medicine. There are no other conflicts of interest. None of the authors have any financial or personal relationships with other people or organisations that could inappropriately influence (bias) their work., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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40. Thrombin generation, bleeding and hemostasis in humans: Protocol for a scoping review of the literature.
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Shaw JR, James T, Douxfils J, Dargaud Y, Levy JH, Brinkman HJM, Shorr R, Siegal D, Castellucci LA, Gross P, Khalife R, Sperling C, Page D, Fergusson D, and Carrier M
- Subjects
- Humans, Hemorrhage, Blood Coagulation, Anticoagulants, Research Design, Review Literature as Topic, Thrombin, Hemostatics
- Abstract
Introduction: Hemostasis and bleeding are difficult to measure. Thrombin generation assays (TGAs) can measure both procoagulant and anticoagulant contributions to coagulation. TGAs might prove useful for the study of bleeding disorders. There has been much progress in TGA methodology over the past two decades, but its clinical significance is uncertain. We will undertake a scoping review of the literature to synthesize available information on the application of TGAs towards the study of bleeding and hemostasis, TGA methodologies being used and to summarize available literature on associations between TGA parameters, bleeding and hemostatic outcomes., Methods and Analysis: MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) will be searched in collaboration with an information specialist. Title/abstract and full-text screening will be carried out independently and in duplicate; eligible study types will include randomized controlled trials, non-randomized studies, systematic reviews, and case series reporting TGA results and bleeding/hemostatic outcomes among humans. Mapping the information identified will be carried out with results presented using qualitative data analytical techniques., Ethics and Dissemination: This scoping review will use published, publicly available information. Research ethics approval will not be required. We will disseminate our findings using conference presentations, peer-reviewed publications, social media, and engagement with knowledge users. This review will outline knowledge gaps concerning TGAs, better delineate its applicability as a clinically relevant assay for bleeding. and seek to identify ongoing barriers to its widespread adoption in clinical research, and eventually, in the clinical setting., Trail Regulations: Registration ID with Open Science Framework: osf.io/zp4ge., Competing Interests: J.R. Shaw has received research support in the form of in-kind contributions from Diagnostica Stago. J.H. Levy serves on research or steering committees for Merck, Octapharma and Werfen. D. Siegal has received honoraria from Astra Zeneca, BMS-Pfizer, Roche and Servier paid indirectly to her research institute. L. Castellucci’s research institution has received honoraria from Bayer, BMS-Pfizer Alliance, The Academy for Continued Advancement in Healthcare Education, Amag Pharmaceutical, LEO Pharma, Sanofi, Valeo Pharma, and Servier. R. Khalife has received honoraria from Bayer, Novo Nordisk, Pfizer and Takeda, as well as research support from Canadian Blood Services and the Canadian Hemophilia Society. M. Carrier reports grants from BMS, Leo Pharma and Pfizer, personal fees from BMS, Leo Pharma, Bayer, Pfizer, Servier and Sanofi. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Shaw et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2023
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41. Automation of Protocoling Advanced MSK Examinations Using Natural Language Processing Techniques.
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Eghbali N, Siegal D, Klochko C, and Ghassemi MM
- Abstract
Imaging examination selection and protocoling are vital parts of the radiology workflow, ensuring that the most suitable exam is done for the clinical question while minimizing the patient's radiation exposure. In this study, we aimed to develop an automated model for the revision of radiology examination requests using natural language processing techniques to improve the efficiency of pre-imaging radiology workflow. We extracted Musculoskeletal (MSK) magnetic resonance imaging (MRI) exam order from the radiology information system at Henry Ford Hospital in Detroit, Michigan. The pretrained transformer, "DistilBERT" was adjusted to create a vector representation of the free text within the orders while maintaining the meaning of the words. Then, a logistic regression-based classifier was trained to identify orders that required additional review. The model achieved 83% accuracy and had an area under the curve of 0.87., (©2023 AMIA - All rights reserved.)
- Published
- 2023
42. Effect modification of age and hypertension on cancer and prevalence of self-reported stroke - A cross-sectional study.
- Author
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Lun R, Shaw JR, Roy DC, Siegal D, Ramsay T, Chen Y, and Dowlatshahi D
- Subjects
- Adult, Humans, Cross-Sectional Studies, Risk Factors, Self Report, Prevalence, Canada epidemiology, Stroke epidemiology, Hypertension epidemiology, Neoplasms epidemiology
- Abstract
The objective of this study was to examine the effect modification of age on the relationship between cancer and prevalence of self-reported stroke. We used cross-sectional data from the 2015-2016 iteration of the Canadian Community Health Survey. A multivariable logistic regression model was used to assess the association between cancer and self-reported stroke. Covariates were assessed for effect modification using the maximum likelihood estimation method. We analyzed 86,809 subjects; the prevalence of self-reported stroke was 1.11%. The odds ratio for the association between cancer and self-reported stroke was 1.26 (95% CI 0.98-1.61) after adjusting for age, sex, dyslipidemia, hypertension, diabetes, heart disease, education, and household income. Age and hypertension were found to be effect modifiers, and the association between cancer and self-reported stroke was stronger in younger adults and in those without hypertension. These results suggest that cancer-associated strokes may have unique underlying mechanisms compared to conventional strokes., (© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)
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- 2023
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43. Direct oral anticoagulants versus vitamin K antagonists in the first 3 months after bioprosthetic valve replacement: a systematic review and meta-analysis.
- Author
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Eikelboom R, Whitlock RP, Muzaffar R, Lopes RD, Siegal D, Schulman S, and Belley-Côté EP
- Subjects
- Humans, Hemorrhage, Fibrinolytic Agents therapeutic use, Vitamin K, Administration, Oral, Anticoagulants therapeutic use, Thrombosis
- Abstract
Objectives: We conducted a systematic review and meta-analysis of randomized controlled trials comparing direct oral anticoagulants (DOACs) to vitamin K antagonists (VKAs) in the first 90 days after bioprosthetic valve implantation., Methods: We systematically searched Embase, Medline and CENTRAL. We screened titles, abstracts and full texts, extracted data and assessed the risk of bias in duplicate. We pooled data using the Mantel-Haenzel method and random effects modelling. We conducted subgroup analyses based on the type of valve (transcatheter versus surgical) and timing of initiation of anticoagulation (<7 vs >7 days after valve implantation). We assessed the certainty of evidence using the Grading of Recommendations, Assessments, Development and Evaluation approach., Results: We included 4 studies of 2284 patients with a median follow-up of 12 months. Two studies examined transcatheter valves (1877/2284 = 83%) and 2 examined surgical valves (407/2284 = 17%). We found no statistically significant differences between DOACs and VKAs with regard to thrombosis, bleeding, death or subclinical valve thrombosis. However, there was a subgroup trend towards more bleeding with DOACs when initiated within 7 days of valve implantation., Conclusions: In the existing randomized literature on DOACs versus VKAs in the first 90 days after bioprosthetic valve implantation, there appears to be no difference with regard to thrombosis, bleeding or death. Interpretation of the data is limited by small numbers of events and wide confidence intervals. Future studies should focus on surgical valves and should include long-term follow-up to assess any potential impact of randomized therapy on valve durability., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
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- 2023
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44. Identifying Electronic Health Record Contributions to Diagnostic Error in Ambulatory Settings Through Legal Claims Analysis.
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Krevat SA, Samuel S, Boxley C, Mohan V, Siegal D, Gold JA, and Ratwani RM
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- Humans, Diagnostic Errors prevention & control, Ambulatory Care, Electronic Health Records, Insurance Claim Review
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- 2023
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45. Thrombotic and bleeding outcomes following the perioperative interruption of anticoagulation among patients with nonvalvular atrial fibrillation and active cancer.
- Author
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Aziz J, Wang TF, Siegal D, Douketis J, Le Gal G, Carrier M, and Shaw JR
- Subjects
- Humans, Anticoagulants adverse effects, Warfarin adverse effects, Retrospective Studies, Risk Factors, Treatment Outcome, Postoperative Hemorrhage chemically induced, Postoperative Complications prevention & control, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Atrial Fibrillation drug therapy, Venous Thromboembolism chemically induced, Thrombosis chemically induced, Neoplasms complications, Neoplasms surgery
- Abstract
Background: Patients with cancer are at an increased risk of developing atrial fibrillation (AF) and often need to undergo procedures or surgery that requires periprocedural interruption of anticoagulation. Anticoagulated patients with cancer might be at increased risk of postprocedural thromboembolic and bleeding complications. Data on postprocedural outcomes among patients with concurrent active cancer and AF are sparse., Objective: To assess the 30-day risk of postoperative thromboembolic and major bleeding complications after the periprocedural interruption of anticoagulation among patients with AF and active cancer., Methods: We conducted a single-center retrospective cohort study in patients with active cancer and AF who required periprocedural interruption of anticoagulation for invasive procedures between August 2015 and May 2019. The primary endpoints were the 30-day postoperative risks of arterial thromboembolism (ATE) and major bleeding. The secondary endpoints included the 30-day risks of venous thromboembolism, clinically relevant nonmajor bleeding, and overall mortality., Results: Two hundred sixty-four patients undergoing 302 periprocedural interruptions were included in our study. The 30-day risk of ATE was 0.7% (95% CI, 0.1%-2.4%), and the 30-day risk of major bleeding was 1.7% (95% CI, 0.6%-3.9%). The 30-day risks of venous thromboembolism and clinically relevant nonmajor bleeding were 0.7% (95% CI, 0.1%-2.4%) and 4.3% (95% CI, 2.5%-7.3%), respectively. The overall risk of mortality at 30 days was 1.3% (95% CI, 0.4%-3.4%). There was one fatal postoperative stroke., Conclusions: Patients with AF and active cancer in this study were at relatively low risk for ATE and postoperative bleeding complications when patients were managed according to commonly applied perioperative management recommendations., Competing Interests: Declaration of competing interest T-F. Wang reports research funding from Leo Pharma; advisory board/honoraria: Servier and Valeo. D. Siegal has received honoraria indirectly to her research institute from Astra Zeneca, BMS-Pfizer, Leo Pharma, Roche, Servier. J. Douketis has received research support from Boehringer-Ingelheim, royalties from UptoDate and the Merck Manual, as well as consultant/advisory board fees from Actelion, AGEN, Astra Zeneca, Bayer, Biotie, BMS, Daiichi-Sankyo, Portola, Boehringer-Ingelheim, Cytori, Janssen, Leo Pharma, Pfizer, Medicine CO., Sanofi, Servier, Bristol Meyers Squibb and PhaseBio, in addition to speaker’s fees from Bayer, Boehringer-Ingelheim, Pfizer, Leo Pharma, Sanofi, with all funds deposited into a university-based research account of through the St. Joseph’s Healthcare Foundation. Dr. Le Gal reports grants from Pfizer and Bristol-Myers Squibb and honoraria (not taken as salary) from Pfizer, Leo Pharma and Sanofi and Aspen Pharma. M Carrier reports research funding from Leo Pharma, BMS and Pfizer; advisory board/honoraria: Bayer, Sanofi, Leo Pharma, Pfizer, Servier and Valeo. J.R. Shaw has received fellowship funding through the Thrombosis Canada BMS-Pfizer Fellowship Award and has received research support from Diagnostica Stago., (Copyright © 2022 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.)
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- 2023
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46. DOAC-associated bleeding, hemostatic strategies, and thrombin generation assays - a review of the literature.
- Author
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Shaw JR, Castellucci LA, Siegal D, and Carrier M
- Subjects
- Humans, Dabigatran adverse effects, Anticoagulants therapeutic use, Hemorrhage chemically induced, Hemostasis, Administration, Oral, Thrombin therapeutic use, Hemostatics therapeutic use
- Abstract
Direct oral anticoagulants (DOACs) account for most oral anticoagulant use. DOAC-associated bleeding events are commonly encountered in clinical practice and are associated with substantial morbidity and mortality. Both specific reversal agents and nonspecific hemostatic therapies, such as prothrombin complex concentrates, are used in the management of DOAC-associated bleeding. Measuring hemostatic efficacy and demonstrating a clinical impact from these therapies among studies of bleeding patients is challenging. Thrombin generation assays provide information on the total hemostatic potential of plasma, and have emerged as a promising modality to both measure the impact of DOACs on coagulation and to evaluate the effects of hemostatic therapies among patients with DOAC-associated bleeding. The mechanisms by which nonspecific hemostatic agents impact coagulation and thrombin generation in the context of DOAC therapy are unclear. As a result, we undertook a review of the literature using a systematic search strategy with the goal of summarizing the effects of DOACs on thrombin generation and the effects of both specific reversal agents and nonspecific hemostatic therapies on DOAC-altered thrombin generation parameters. We sought to identify clinical studies focusing on whether altered thrombin generation is associated with clinical bleeding and whether correction of altered thrombin generation parameters predicts improvements in clinical hemostasis. Lastly, we sought to outline future directions for the application of thrombin generation assays toward anticoagulation therapies and the question of anticoagulation reversal., Competing Interests: Declaration of competing interest J.R.S. has received research support in the form of in-kind contributions from Diagnostica Stago. L.A.C.’s research institute has received honoraria from Amag Pharmaceuticals, Bayer, BMS-Pfizer Alliance, the Academy, LEO Pharma, Sanofi, Servier, and Valeo. M.C. has received research funding from BMS, Leo Pharma, and Pfizer, as well as honoraria from Bayer, Sanofi, Servier, BMS, Leo Pharma, and Pfizer, with all payments made to his institution., (Copyright © 2022 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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47. How Did We Get Here? Antithrombotic Therapy after Bioprosthetic Aortic Valve Replacement: A Review.
- Author
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Eikelboom R, Whitlock RP, Lopes RD, Siegal D, Jaffer IH, Drakos P, Schulman S, and Belley-Côté EP
- Subjects
- Humans, Anticoagulants adverse effects, Aortic Valve surgery, Heart Valve Prosthesis, Treatment Outcome, Randomized Controlled Trials as Topic, Fibrinolytic Agents adverse effects, Heart Valve Prosthesis Implantation
- Abstract
Importance: Aortic stenosis is the most common valvular disease, and more than 90% of patients who undergo aortic valve replacement receive a bioprosthetic valve. Yet optimal antithrombotic therapy after bioprosthetic aortic valve replacement remains uncertain, and guidelines provide contradictory recommendations., Observations: Randomized studies of antithrombotic therapy after bioprosthetic aortic valve replacement are small and underpowered. Observational data present opposing, and likely confounded, results. Historically, changes to guidelines have not been informed by high-quality new data. Current guidelines from different professional bodies provide contradictory recommendations despite citing the same evidence., Conclusion: Insufficient antithrombotic therapy after bioprosthetic aortic valve replacement has serious implications: ischemic stroke, systemic arterial thromboembolism, and clinical and subclinical valve thromboses. Unnecessarily intense antithrombotic therapy, however, increases risk of bleeding and associated morbidity and mortality. Professional bodies have used the current low-quality evidence and generated incongruent recommendations. Researchers should prioritize generating high-quality, randomized evidence evaluating the risks and benefits of antiplatelet versus anticoagulant therapy after bioprosthetic aortic valve replacement., Competing Interests: None declared., (Thieme. All rights reserved.)
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- 2023
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48. Perceptions of patients and healthcare providers on patient education to improve oral anticoagulant management.
- Author
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Wang M, Swinton M, Troyan S, Ho J, M Siegal D, Mbuagbaw L, Thabane L, and M Holbrook A
- Subjects
- Humans, Administration, Oral, Health Personnel, Ontario, Anticoagulants, Patient Education as Topic
- Abstract
Rationale and Objectives: Education of patients is thought to be key to high-quality oral anticoagulant (OAC) medication management. Theoretically, improving patients' knowledge should improve their self-management skills and adherence. The study's objective was to explore the opinions of healthcare providers and patients on the desired content and format of patient education on OACs, in addition to perceived barriers to high-quality patient education., Methods: We applied qualitative descriptive methods in a focus group study on OAC management. Five focus group discussions were conducted in two health regions in Southwestern Ontario from 2017 to 2018 with 19 patients, 7 caregivers and 16 healthcare providers (physicians, nurses and pharmacists). During the focus groups, participants discussed their experiences with OAC education and made suggestions about the content and format for patient education on OACs. Transcripts were analysed using conventional content analysis., Results: We identified the five themes of patient education on OAC management: content of OAC education (rationale, risk and appropriate drug administration methods), the best times for providing OAC education (time of OACs initiation along with continuing education), preferred education delivery strategies (case management targeted patient information summaries from authoritative sources such as Thrombosis Canada and video education), patient and community pharmacist engagement in OAC education, and perceived barriers to optimal patient education (patients depending too much on their healthcare providers for advice, the limited time patients spend with healthcare providers, gaps in clear communication between providers and the lack of a nationally or provincially coordinated OAC management programme)., Conclusion: Our findings suggest that patients, caregivers and healthcare providers support the need for education on OACs, including for patients taking DOACs. Specific important content and proper education format are needed. The optimal combination of content, format, duration, timing and sources for OAC education requires further research., (© 2022 John Wiley & Sons Ltd.)
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- 2022
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49. Cancer and stroke: What do we know and where do we go?
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Lun R, Siegal D, Ramsay T, and Dowlatshahi D
- Subjects
- Humans, Reperfusion, Secondary Prevention, Neoplasms complications, Stroke etiology, Stroke therapy
- Abstract
Cancer is an increasingly recognized cause for ischemic stroke, with recent acknowledgement of cancer-related stroke as an emerging stroke subtype with unique pathophysiologic mechanisms. In addition, cancer-related stroke may differ from stroke in the general population as cancer patients may not receive guideline-recommended stroke care, and the occurrence of stroke may also preclude patients from receiving optimal cancer treatments. Due to the high degree of morbidity and mortality associated with both conditions, understanding the relationship between stroke and cancer is crucial. In this narrative review, we discuss the association between cancer and stroke, the unique pathophysiologic mechanisms underlying this phenomenon, treatment options including acute reperfusion therapies and secondary prevention strategies, compare outcomes between cancer-related stroke and stroke in the general population, and review new and emerging evidence in this field., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
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- 2022
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50. No apparent association between mRNA COVID-19 vaccination and venous thromboembolism.
- Author
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Nicholson M, Goubran H, Chan N, and Siegal D
- Subjects
- Adult, Humans, COVID-19 Vaccines adverse effects, RNA, Messenger, Vaccination adverse effects, mRNA Vaccines, Venous Thromboembolism epidemiology, Venous Thromboembolism etiology, COVID-19 prevention & control, Vaccines, Purpura, Thrombocytopenic, Idiopathic
- Abstract
By January 2022 over ten billion doses of COVID-19 vaccines had been administered worldwide. Concerns about COVID-19 vaccine-associated thrombosis arose after the characterization of a rare prothrombotic condition associated with adenoviral vector-based COVID-19 vaccines known as vaccine-induced immune thrombotic thrombocytopenia (VITT). Although mRNA COVID-19 vaccines have not been linked to VITT, concerns about thrombosis after vaccination persist despite safety data from hundreds of millions of recipients of mRNA COVID-19 vaccines. With widespread vaccination some VTE will occur shortly after vaccination by chance alone because VTE is a common condition that affects 1 to 2 in 1000 persons each year. Detailed analysis is required to determine whether these VTE events are coincidental or associated when they occur in close proximity to mRNA vaccine administration. This paper will review what is currently known about rates of VTE after mRNA vaccination in adults, discuss the reasons why uncertainty on this topic persists, and briefly review the implications of these findings for clinical practice and health policy., Competing Interests: Declaration of Competing Interest MN, HG, and NC, have no conflicts of interest relevant to this manuscript. DS has received honoraria from BMS-Pfizer, Leo Pharma, Novartis, Portola, and Servier., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2022
- Full Text
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