TY - JOUR
T1 - The management of acute venous thromboembolism in clinical practice - study rationale and protocol of the European PREFER in VTE Registry
AU - Agnelli, Giancarlo
AU - Gitt, Anselm K.
AU - Bauersachs, Rupert
AU - Fronk, Eva-Maria
AU - Laeis, Petra
AU - Mismetti, Patrick
AU - Monreal, Manuel
AU - Willich, Stefan N.
AU - Wolf, Wolf-Peter
AU - Cohen, Alexander T.
AU - PREFER in VTE investigators
AU - Irvine, Nicola
N1 - Funding Information:
The authors acknowledge the substantial contribution of Dr. Markus Schwertfeger (Daiichi Sankyo) for his input into the design and setup of the registry. Furthermore we are indebted to all investigators across Austria, France, Germany, Italy, Spain, Switzerland and the UK who have made this registry possible. A full list of the PREFER in VTE investigators is given in the Appendix. Editorial assistance during the development of this manuscript was provided by Paul Barlass and Matthew Bexon of in Science Communications, Springer Healthcare. This assistance was funded by Daiichi Sankyo Europe GmbH, Munich, Germany.
PY - 2015/10/21
Y1 - 2015/10/21
N2 - Background: Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe. However, there is a paucity of data on the current management in real life, including factors influencing treatment pathways, patient satisfaction, quality of life (QoL), and utilization of health care resources and the corresponding costs. The PREFER in VTE registry has been designed to address this and to understand medical care and needs as well as potential gaps for improvement. Methods/design: The PREFER in VTE registry was a prospective, observational, multicenter study conducted in seven European countries including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the characteristics and the management of patients with VTE, the use of health care resources, and to provide data to estimate the costs for 12 months treatment following a first-time and/or recurrent VTE diagnosed in hospitals or specialized or primary care centers. In addition, existing anticoagulant treatment patterns, patient pathways, clinical outcomes, treatment satisfaction, and health related QoL were documented. The centers were chosen to reflect the care environment in which patients with VTE are managed in each of the participating countries. Patients were eligible to be enrolled into the registry if they were at least 18 years old, had a symptomatic, objectively confirmed first time or recurrent acute VTE defined as either distal or proximal deep vein thrombosis, pulmonary embolism or both. After the baseline visit at the time of the acute VTE event, further follow-up documentations occurred at 1, 3, 6 and 12 months. Follow-up data was collected by either routinely scheduled visits or by telephone calls. Results: Overall, 381 centers participated, which enrolled 3,545 patients during an observational period of 1 year. Conclusion: The PREFER in VTE registry will provide valuable insights into the characteristics of patients with VTE and their acute and mid-term management, as well as into drug utilization and the use of health care resources in acute first-time and/or recurrent VTE across Europe in clinical practice.
AB - Background: Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe. However, there is a paucity of data on the current management in real life, including factors influencing treatment pathways, patient satisfaction, quality of life (QoL), and utilization of health care resources and the corresponding costs. The PREFER in VTE registry has been designed to address this and to understand medical care and needs as well as potential gaps for improvement. Methods/design: The PREFER in VTE registry was a prospective, observational, multicenter study conducted in seven European countries including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the characteristics and the management of patients with VTE, the use of health care resources, and to provide data to estimate the costs for 12 months treatment following a first-time and/or recurrent VTE diagnosed in hospitals or specialized or primary care centers. In addition, existing anticoagulant treatment patterns, patient pathways, clinical outcomes, treatment satisfaction, and health related QoL were documented. The centers were chosen to reflect the care environment in which patients with VTE are managed in each of the participating countries. Patients were eligible to be enrolled into the registry if they were at least 18 years old, had a symptomatic, objectively confirmed first time or recurrent acute VTE defined as either distal or proximal deep vein thrombosis, pulmonary embolism or both. After the baseline visit at the time of the acute VTE event, further follow-up documentations occurred at 1, 3, 6 and 12 months. Follow-up data was collected by either routinely scheduled visits or by telephone calls. Results: Overall, 381 centers participated, which enrolled 3,545 patients during an observational period of 1 year. Conclusion: The PREFER in VTE registry will provide valuable insights into the characteristics of patients with VTE and their acute and mid-term management, as well as into drug utilization and the use of health care resources in acute first-time and/or recurrent VTE across Europe in clinical practice.
KW - Anticoagulation
KW - Novel Oral Anticoagulants
KW - Prevention
KW - Registry
KW - Venous Thromboembolism
KW - Vitamin K antagonists
U2 - 10.1186/s12959-015-0071-z
DO - 10.1186/s12959-015-0071-z
M3 - Article
AN - SCOPUS:84944896576
SN - 1477-9560
VL - 13
JO - Thrombosis Journal
JF - Thrombosis Journal
IS - 1
M1 - 41
ER -