2008© COPYRIGHT Bryce A. Kerlin ATHN Data Summit Thrombosis Data Collection: Lessons Learned from the HTRS TERegistry Bryce A. Kerlin, MD Director, Hemostasis.

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Presentation transcript:

2008© COPYRIGHT Bryce A. Kerlin ATHN Data Summit Thrombosis Data Collection: Lessons Learned from the HTRS TERegistry Bryce A. Kerlin, MD Director, Hemostasis & Thrombosis Center Nationwide Children’s Hospital Assistant Professor of Pediatrics The Ohio State University College of Medicine

2008© COPYRIGHT Bryce A. Kerlin 2 Topics HTRS TERegistry: – Registry Objectives – Data Collection – Quality Control / Data Integrity – Accrual and Enrollment Limitations ATHN Specific Issues: – Limitations of Data Quantity – Role of ATHN in Thrombosis Research – Protection of Investigator(s)

2008© COPYRIGHT Bryce A. Kerlin 3 TERegistry Obejectives 1. Prospectively evaluate the epidemiology and clinical characteristics of the known prothrombotic risk factors in persons with TE by developing a clinical informatics database (“registry”). 2. Identify the frequency and nature of complications associated with TE and its treatment. 3. Describe the phenotypes and complications seen in persons with multiple molecular risk factors. 4. Compare the epidemiology, clinical characteristics, and complications seen in persons with and without known risk factors. May be better described as a “natural history” study.

2008© COPYRIGHT Bryce A. Kerlin 4 Inclusion / Exclusion Inclusion: – Patient’s first TE. – DVT, Arterial, Intra-Cardiac Thrombi; PE; Arterial TE; Stroke (<20 yrs); MI (<20 yrs). – Specific criteria for diagnosis must be met. Exclusion: – Bleeding Disorders; TIA; Sickle Cell; Metabolic Disorders associated with Stroke; Hemorrhagic Stroke; Bacterial Endocarditis; MAHA.

2008© COPYRIGHT Bryce A. Kerlin 5 Data Entry Paper Data Worksheets – For medical record abstraction Worksheets – Broken down into data types (registration, lab data, etc.) Worksheets faxed to main study center (NCH/OSU) Data Transcribed into secure database – Quality Control Worksheets archived at NCH and at primary institution

2008© COPYRIGHT Bryce A. Kerlin 6 Data Collection Flow

2008© COPYRIGHT Bryce A. Kerlin 7 Typical Worksheets

2008© COPYRIGHT Bryce A. Kerlin 8 Database Screenshots

2008© COPYRIGHT Bryce A. Kerlin 9 Database Screenshots

2008© COPYRIGHT Bryce A. Kerlin 10 Quality Control / Data Integrity Data Entry – Single person enters data Quarterly Data Survey – 6 random charts audited for accurate data entry on a quarterly basis – 3 new registrations / 2 follow-ups / 1 recurrence Database – Nightly Backup – Password Protected – Encrypted – Access Limited to Study Personnel

2008© COPYRIGHT Bryce A. Kerlin 11 Enrollment Current: 110 patients <20 years old – Adult enrollment much slower Goal: 500 patients <20 years old

2008© COPYRIGHT Bryce A. Kerlin 12 Adult Enrollment Barriers Late presentation to study center Limited Diagnostic Data available Less frequently tested for thrombophilia Epidemiology / Natural History already better defined Lack of Research Assistant Support / Infrastructure

2008© COPYRIGHT Bryce A. Kerlin 13 Pediatric Enrollment Issues

2008© COPYRIGHT Bryce A. Kerlin 14 Pediatric Enrollment Issues Other: – Debate regarding utility of thrombophilia testing

2008© COPYRIGHT Bryce A. Kerlin ATHN Specific Issues

2008© COPYRIGHT Bryce A. Kerlin 16 Data Quantity “UDC Style” – Epidemiology Driven Database / Registry “COG / Alternate Style” – Hypothesis Driven Database / Registry MD A B C D E A A B A B C A B C D E

2008© COPYRIGHT Bryce A. Kerlin 17 ATHN Role in Thrombosis Research Facilitator? – i.e. Data Warehouse – Provides means to collect data, distribute data, and provider of research tools Statistical support Scientific Review Prioritization Scientific Body? – i.e. Study Group – Development of Hypotheses – Study Design Both?

2008© COPYRIGHT Bryce A. Kerlin 18 Investigator Protection Massive Time and Effort Intellectual Property Data integrity must be preserved for the initiating investigator(s) utilization Examples: – HTRS TERegistry Co-owned by Kerlin, NCH, HTRS – CDC Pilot Co-owned by CDC and Pilot Centers