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Real World Evidence and Claims Databases – a Guide for Healthcare Professionals
Prof. Craig I. Coleman gives an appreciation of the methodology used to perform Real World Evidence studies, particularly those investigating the effectiveness and safety, of non-vitamin K antagonist oral anticoagulants (or NOACs) in non-valvular atrial fibrillation patients. He also provides some key insights on what real world evidence and specifically claims databases can - and cannot - tell us. Approval number: PP-XAR-ALL-0036-2
For more information visit:
Clinicaltrials.gov study record (Accessed 9 November 2020
Related key publications:
Haas S, Holberg G, Kreutz R et al. The effects of timing of prophylaxis, type of anesthesia, and use of mechanical methods on outcome in major orthopedic surgery - subgroup analyses from 17,701 patients in the XAMOS study. Vasc Health Risk Manag 2016;12:209−218.
Kreutz R, Haas S, Holberg G et al. Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co-medication interactions. Br J Clin Pharmacol 2016;81:724−734.
Lassen MR, Haas S, Kreutz R et al. Rivaroxaban for thromboprophylaxis after fracture-related orthopedic surgery in routine clinical practice. Clin Appl Thromb Hemost 2016;22:138−146.
Turpie AGG, Haas S, Kreutz R et al. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost 2014;111:94–102.
Turpie AGG, Schmidt AC, Kreutz R et al. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery. Vasc Health Risk Manag 2012;8:363–370.
For more information visit:
The Global Orthopaedic Registry (Accessed 9 November 2020)
Related key publications:
Wang Z, Anderson FA Jr, Ward M, Bhattacharyya T. Surgical site infections and other postoperative complications following prophylactic anticoagulation in total joint arthroplasty. PLoS One 2014;9:e91755.
Anderson FA, Jr, Agnelli G, FitzGerald G et al. Overview of the Global Orthopaedic Registry (GLORY). Am J Orthop 2010;39:2–4.
Cushner F, Agnelli G, FitzGerald G et al. Complications and functional outcomes after total hip arthroplasty and total knee arthroplasty: results from the Global Orthopaedic Registry (GLORY). Am J Orthop 2010;39:22–28.
Friedman RJ, Gallus A, Gil-Garay E et al. Practice patterns in the use of venous thromboembolism prophylaxis after total joint arthroplasty–insights from the multinational Global Orthopaedic Registry (GLORY). Am J Orthop 2010;39:14–21.
Waddell J, Johnson K, Hein W et al. Orthopedic practice in total hip arthroplasty and Total knee arthroplasty: results from the Global Orthopaedic Registry (GLORY) Am J Orthop 2010;39:5–13.
Warwick D, Agnelli G, Cushner F et al. Lessons learned from the Global Orthopaedic Registry (GLORY): study design, current practice patterns, and future directions. Am J Orthop 2010;39:29–31.
Friedman RJ, Gallus AS, Cushner FD et al. Physician compliance with guidelines for deep-vein thrombosis prevention in total hip and knee arthroplasty. Curr Med Res Opin 2008;24:87–97.
For more information visit:
International Medical Prevention Registry on VTE (Accessed 9 November 2020)
In-hospital VTE and bleeding risk model calculator (Accessed 9 November 2020)
Related key publications:
Hostler DC, Marx ES, Moores LK et al. Validation of the International Medical Prevention Registry on Venous thromboembolism bleeding risk score. Chest 2016;149:372−379.
Rosenberg D, Eichorn A, Alarcon M et al. External validation of the risk assessment model of the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) for medical patients in a tertiary health system. J Am Heart Assoc 2014;3:e001152.
Decousus H, Tapson VF, Bergmann JF et al. Factors at admission associated with bleeding risk in medical patients: findings from the IMPROVE investigators. Chest 2011;139:69–79.
Spyropoulos AC, Anderson FA Jr, Fitzgerald G et al. Predictive and associative models to identify hospitalized medical patients at risk for VTE. Chest 2011;140:706–714.
Tapson VF, Decousus H, Pini M et al. Venous thromboembolism prophylaxis in acutely ill hospitalized medical patients: findings from the International Medical Prevention Registry on Venous Thromboembolism. Chest 2007;132:936–945.
For more information visit:
Related key publications:
Anderson FA Jr, Goldhaber SZ, Tapson VF et al. Improving practices in US hospitals to prevent venous thromboembolism: lessons from ENDORSE. Am J Med 2010;123:1099–1106.e8.
Bergmann JF, Cohen AT, Tapson VF et al. Venous thromboembolism risk and prophylaxis in hospitalized medically ill patients: the ENDORSE global survey. Thromb Haemost 2010;103:736–748.
Kakkar AK, Cohen AT, Tapson VF et al. Venous thromboembolism risk and prophylaxis in the acute care hospital setting (ENDORSE survey): findings in surgical patients. Ann Surg 2010;251:330–338.
Cohen AT, Tapson VF, Bergmann JF et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet 2008;371:387–394.
For more information visit:
Computerized registry of patients with venous thromboembolism (Accessed 9 November 2020)
Related key publications:
Bikdeli B, Jimenez D, Hawkins M et al. Rationale, Design and methodology of the computerized registry of patients with venous thromboembolism (RIETE). Thromb Haemost 2018;118:214–224.
Brenner B, Bikdeli B, Tzoran I et al. Arterial ischemic events are a major complication in cancer patients with venous thromboembolism. Am J Med 2018: doi:10.1016/j.amjmed.2018.04.037
Chai-Adisaksopha C, Iorio A, Crowther MA et al. Vitamin K antagonists after 6 months of low-molecular-weight heparin in cancer patients with venous thromboembolism. Am J Med 2018;131:430–437.
Frere C, Trujillo-Santos J, Font C et al. Clinical course of venous thromboembolism in patients with pancreatic cancer: insights from the RIETE registry. Thromb Haemost 2018;118:1119–1122.
Galanaud JP, Bertoletti L, Amitrano M et al. Predictors of post-thrombotic ulcer after acute DVT: the RIETE registry. Thromb Haemost 2018;118:320–328.
Jara-Palomares L, Otero R, Jimenez D et al. Validation of a prognostic score for hidden cancer in unprovoked venous thromboembolism. PLoS One 2018;13:e0194673.
Jiménez D, Bikdeli B, Barrios D et al. Management appropriateness and outcomes of patients with acute pulmonary embolism. Eur Respir J 2018;51:1800445.
Kuperman A, López-Reyes R, Bosco LJ et al. Anemia and bleeding in patients receiving anticoagulant therapy for venous thromboembolism. J Thromb Thrombolysis 2018;45:360–368.
Lobo JL, Garcia-Fuertes JA, Trujillo-Santos J et al. Anticoagulant therapy for venous thromboembolism in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol 2018;30:526–530.
Tufano A, Ageno W, Di Micco P et al. Outcomes during anticoagulation in patients with symptomatic vs. incidental splanchnic vein thrombosis. Thromb Res 2018;164:69–74.
Bustos Merlo AB, Arcelus Martínez JI, Turiño Luque JD et al. Form of presentation, natural history and course of postoperative venous thromboembolism in patients operated on for pelvic and abdominal cancer. Analysis of the RIETE registry. Cir Esp 2017;95:328–334.
Guy JB, Bertoletti L, Magné N et al. Venous thromboembolism in radiation therapy cancer patients: Findings from the RIETE registry. Crit Rev Oncol Hematol 2017;113:83–89.
Tafur AJ, Caprini JA, Cote L et al. Predictors of active cancer thromboembolic outcomes. RIETE experience of the Khorana score in cancer-associated thrombosis. Thromb Haemost 2017;117:1192–1198.
Merah A, Bertoletti L, Ginzarly M et al. Prior thromboprophylaxis and outcome in patients experiencing acute venous thromboembolism after an acute medical illness. Eur J Intern Med 2016;30:72–76.
Morillo R, Jiménez D, Aibar MÁ et al. Deep vein thrombosis management and outcome trends, 2001 to 2014. Chest. 2016;150:374–383.
Baumann Kreuziger L, Cote L, Verhamme P et al. A RIETE registry analysis of recurrent thromboembolism and hemorrhage in patients with catheter-related thrombosis. J Vasc Surg Venous Lymphat Disord 2015;3:243–250.
Madridano O, Del Toro J, Lorenzo A et al. Subsequent arterial ischemic events in patients receiving anticoagulant therapy for venous thromboembolism. J Vasc Surg Venous Lymphat Disord 2015;3:135–141.
Mahé I, Sterpu R, Bertoletti L et al. Long-term anticoagulant therapy of patients with venous thromboembolism. What are the practices? PLoS One 2015;10:e0128741.
Tzoran I, Brenner B, Papadakis M et al. VTE registry: what can be learned from RIETE? Rambam Maimonides Med J 2014;5:e0037.
Tzoran I, Brenner B, Sakharov G et al. Clinical outcome in patients with venous thromboembolism receiving concomitant anticoagulant and antiplatelet therapy. Eur J Intern Med 2014;25:821–825.
Blondon M, Righini M, Aujesky D et al. Usefulness of preemptive anticoagulation in patients with suspected pulmonary embolism: a decision analysis. Chest 2012;142:697–703.
Tzoran I, Saharov G, Brenner B et al. Silent pulmonary embolism in patients with proximal deep vein thrombosis in the lower limbs. J Thromb Haemost 2012;10:564–571.
Jiménez D, Aujesky D, Díaz G et al. Prognostic significance of deep vein thrombosis in patients presenting with acute symptomatic pulmonary embolism. Am J Respir Crit Care Med 2010;181:983–991.
Maestre A, Sánchez R, Rosa V et al. Clinical characteristics and outcome of inpatients versus outpatients with venous thromboembolism: findings from the RIETE registry. Eur J Intern Med 2010;21:377–382.
Ruíz-Giménez N, Suárez C, González R et al. Predictive variables for major bleeding events in patients presenting with documented acute venous thromboembolism. Findings from the RIETE registry. Thromb Haemost 2008;100:26–31.
For more information visit:
Global Anticoagulant Registry in the FIELD (GARFIELD-VTE) (Accessed 9 November 2020)
Related key publications:
Weitz JI, Haas S, Ageno W et al. Global Anticoagulant Registry in the Field - Venous Thromboembolism (GARFIELD-VTE). Rationale and design. Thromb Haemost 2016;116:1172–1179.
For more information visit:
Clinicaltrials.gov study record (Accessed 9 November 2020)
Related key publications:
Cano S, Mantovani LG, Folkerts K et al. Patient-reported treatment experience with oral rivaroxaban: results from the noninterventional XALIA study of deep-vein thrombosis. TH Open 2018;2:e139–e146.
Ageno W, Mantovani LG, Haas S et al. Subgroup analysis of patients with cancer in XALIA: A noninterventional study of rivaroxaban versus standard anticoagulation for VTE. TH Open 2017;1:e33–e42.
Turpie AGG, Mantovani LG, Haas S et al. Analysis of patients with deep vein thrombosis switched from standard therapy to rivaroxaban in the non-interventional XALIA study. Thromb Res 2017;155:23–27.
Ageno W, Mantovani LG, Haas S et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol 2016;3:e12–e21.
Ageno W, Mantovani LG, Haas S et al. XALIA: rationale and design of a non-interventional study of rivaroxaban compared with standard therapy for initial and long-term anticoagulation in deep vein thrombosis. Thromb J 2014;12:16.
For more information visit:
Related key publications:
Agnelli G, Gitt AK, Bauersachs R et al. The management of acute venous thromboembolism in clinical practice – study rationale and protocol of the European PREFER in VTE registry. Thromb J 2015;13:41.
Bauersachs R, Gitt AK, Mismetti P et al. Readmittance to hospital within 6 months after a venous thromboembolism event: PREFER in VTE registry. Value Health 2014;17:A472–A473.
Willich SN, Bauersachs R, Gitt AK et al. Treatment satisfaction in patients with venous thromboembolism as measured with PACT-Q2: PREFER in VTE registry. Value Health 2014;17:A496–A497.