athn data summit thrombosis data collection: lessons learned from the htrs teregistry
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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. Topics. HTRS TERegistry: - PowerPoint PPT PresentationTRANSCRIPT
2008© COPYRIGHTBryce A. Kerlin
ATHN Data Summit
Thrombosis Data Collection: Lessons Learned from the HTRS TERegistryBryce A. Kerlin, MDDirector, Hemostasis & Thrombosis CenterNationwide Children’s Hospital Assistant Professor of PediatricsThe Ohio State University College of Medicine
2008© COPYRIGHTBryce A. Kerlin
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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© COPYRIGHTBryce A. Kerlin
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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© COPYRIGHTBryce A. Kerlin
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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© COPYRIGHTBryce A. Kerlin
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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© COPYRIGHTBryce A. Kerlin
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Data Collection Flow
2008© COPYRIGHTBryce A. Kerlin
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Typical Worksheets
2008© COPYRIGHTBryce A. Kerlin
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Database Screenshots
2008© COPYRIGHTBryce A. Kerlin
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Database Screenshots
2008© COPYRIGHTBryce A. Kerlin
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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© COPYRIGHTBryce A. Kerlin
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Enrollment
• Current: 110 patients <20 years old
– Adult enrollment much slower
• Goal: 500 patients <20 years old
Total # Patients Enrolled (Peds/Adults vs. Time)
0
10
20
30
40
50
60
70
80
90
Sep-0
5
Nov-05
Jan-
06
Mar
-06
May
-06
Jul-0
6
Sep-0
6
Nov-06
Jan-
07
Mar
-07
May
-07
Jul-0
7
Sep-0
7
Nov-07
Time (Month)
# p
atie
nts
en
roll
ed
Pediatric Patients Adult Patients
2008© COPYRIGHTBryce A. Kerlin
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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© COPYRIGHTBryce A. Kerlin
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Pediatric Enrollment Issues
2008© COPYRIGHTBryce A. Kerlin
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Pediatric Enrollment Issues
• Other:
– Debate regarding utility of thrombophilia testing
2008© COPYRIGHTBryce A. Kerlin
ATHN Specific Issues
2008© COPYRIGHTBryce A. Kerlin
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Data Quantity• “UDC Style”
– Epidemiology Driven Database / Registry
• “COG / Alternate Style”
– Hypothesis Driven Database / Registry
MDA
MDB
MDC
MDD
E
MDA
MDA
B
MDA
B
C
MDA
B
C
D
E
2008© COPYRIGHTBryce A. Kerlin
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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© COPYRIGHTBryce A. Kerlin
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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