Epidemiologic International Day For the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting Sponsored by an unrestricted educational grant from sanofi-aventis to the Center for Outcomes Research, University of Massachusetts Medical School

ENDORSE 2 Unique Strengths  Cross-sectional cohort study  Multi-national perspective  Representative populations –Hospitals –Patients  National and worldwide estimates of VTE risk factors and prophylaxis use

ENDORSE 3 35 ENDORSE Countries

ENDORSE 4 35 Participating Countries  Algeria  Australia  Bangladesh  Brazil  Bulgaria  Columbia  Czech Republic  Egypt  France  Germany  Greece  Gulf States  Russia  Saudi Arabia  Slovakia  Spain  Switzerland  Thailand  Tunisia  Turkey  UK  USA  Venezuela  Hungary  India  Ireland  Israel  Italy  Mexico  Morocco  Pakistan  Poland  Portugal  Romania

ENDORSE 5 Objectives  To identify patients at risk for venous thromboembolism (VTE) among medical and surgical patients hospitalized in representative hospitals throughout the world  To determine the proportion of at-risk hospital patients who receive effective types of VTE prophylaxis

ENDORSE 6 Study Design  Cross sectional, observational survey –Enroll patients at “a single point in time” –Actual enrollment may take one month  Multinational perspective  Representative hospitals in each country  Consecutive patients within pre-specified wards

ENDORSE 7 Hospital Inclusion Criteria  Acute care hospitals  Randomly selected from country-wide lists  More than 50 beds  General medical & surgical wards  At least one general surgical ward  Schedule elective major surgical cases  Agree to participate in ENDORSE

ENDORSE 8 Patient Inclusion Criteria Medical Patients  40 years of age or older  Admitted for treatment of a serious medical illness Surgical Patients  18 years of age or older  Underwent a major surgical operation, which required general or epidural anesthesia lasting at least 45 minutes.  Had a major traumatic event, not requiring an operation, including closed head injury

ENDORSE 9 ENDORSE Steering Committee Co-Chairs: Ander Cohen & Victor Tapson Committee Members Jean-Francois Bergmann France Ander Cohen United Kingdom Samuel GoldhaberUnited States Ajay Kakkar United Kingdom Victor Tapson United States Director, Study Coordinating Center Fred Anderson United States

ENDORSE 10 Study Timeline First PIs meeting, Paris February Select study hospitals April Investigator training September Data collection October Data analysis December Second PIs meeting March 2007 ISTH abstract and main publication July 2007

ENDORSE 11 Motivation for Hospitals to Participate  Provide investigator at each hospital a confidential summary report showing a local profile of DVT risk and prophylaxis use, benchmarked against the country  Reimburse for effort of local data abstractor Or  Provide a data abstractor contracted by a CRO

ENDORSE 12 ENDORSE will Overcome Important Limitations of IMPROVE  Multinational perspective  Representative –Hospitals –Both medical and surgical patients  Can be used to make national estimates –Magnitude of VTE risk in-hospitals –Gap between trial evidence and real-world practices in prophylaxis use