Transcript WG 2 neufeld ATHN - Data Summit Thrombosis 05 23 08

Thrombosis/thrombophilia patients
captured at HTCs participating in
ATHN
Ellis J. Neufeld MD, PhD
Director, Boston Hemophilia Center
Director, Thrombosis Service, Children’s Hospital Boston
Associate Professor of Pediatrics, Harvard Medical School
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Topics
• How does the over-arching ATHN structure allow
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for thrombosis (or thrombophilia or both) to fit in
with hemophilia data efforts?
How are sites which responded to ATHN surveys
seeing thrombosis patients?
Regardless of how the patients are seen, how are
these sites collecting data about
thrombosis/thrombophilia?
Audience participation – what are we doing now?
Where do we go from here?
Light blue text: Neufeld editorial comments
2008© COPYRIGHT
Shared and distinct characteristics between
bleeding disorders and thrombosis, clinical
research, public health
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Incidence and prevalence: thrombotic disorders are vastly more common
than inherited bleeding disorders.
– Hemophilia ~20,000 individuals, life-long disorders
– Thrombophilia -5% of Caucasian population with factor V Leiden, but
only a minority get clots.
– Thrombosis - >>100,000 new cases per year of DVT, plus hundreds of
thousands of arterial thrombotic events
– Closest relative incidence: thrombosis in thrombophilia patients plus
severe thrombophilias, e.g. protein C or AT3 deficiency
Caregivers: Expertise in bleeding disorders and thrombophilias tends to
reside in the same group of hematologists.
– But Hemophilia Centers are often distinct and relatively few in number,
and
– Anticoagulation clinics, which deal with warfarin or heparin for any
indication are even more often distinct
Funding streams –
– CDC thrombosis centers vs HTCs
– 340B funding and mission statement of HTCs
– Relationship to industry VERY different for thrombosis and bleeding
disorders (except the rare severe protein deficiencies)
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ATHN’s Strategic Direction
(In principle, each of these five elements can
apply to thrombosis and thrombophilia)
Network
Infrastructure
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Develop
electronic
database
capacity
Data
Management
Data safety,
back-up, and
portability
Public Health
and Safety
Outcomes
Improvement
Data Analysis
and Research
Support
surveillance
and patient
safety
Use data to
drive quality,
service,
and patient
centered
care
Facilitate
knowledge
creation and
advocacy
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HTC Needs Assessment
Focus on thrombosis/thrombophilia responses
• eSurvey on ATHN website
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– Initiated mid-October 2007
• Respondents
– 79 of 134 (59%) HTCs responded
– All 6 (100%) Region VII responded
• Objectives of survey
– Assess state of current data
collection and use
– Facilitate improved data collection
– Develop fact base to provide data
manager funding/support to HTC’s
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Currently Using Lab Tracker
Users
Non Users
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(Based on 79
Respondents)
We may be hearing back
mostly from the choir
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Data Routinely Computerized in Lab Tracker
Infusion records
Labs
Meds- Other
Med - Coag
% of HTCs
Surgeries
(Based on 78
Respondents)
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Diagnoses
Contacts
0
20
40
60
80
100
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Patient Types Entered into Lab Tracker
er
th
O
ar
rie
rs
C
s
Di
so
rd
er
el
et
bo
ti c
at
Pl
Bl
e
Th
ro
m
ed
in
g
D
O
th
H
er
em
8
VW
op
hi
li
a
100
80
60
40
20
0
% of HTC Lab Tracker Users
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Thrombosis Patients
100%
80%
60%
Within A Separate AntiCoag/Thrombosis Clinic/Other
Within HTC
40%
20%
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0%
Where Are Patients Seen?
Audience
participation –
what does “within
hemophilia Ctr
mean to you?
(Based on the initial 78 respondents)
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Patients with Thrombotic Disorder at HTC
This adds up to AT LEAST 6000 patients “without
even trying”. But 2/3 of these at 15 sites
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20
18
16
14
12
10
8
6
4
2
0
1-50
51-99
100-199
200-299
>300
51 of 78 HTCs
reporting
#HTC
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Types of Thrombosis Patients Seen
100
80
60
40
20
0
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Peds w
Thombosis
Peds w
Hereditary
Thrombosis
These categories are
very different, but not
mutually exclusive
Adults w
Thrombosis
Adults w
Hereditary
Thrombosis
% of HTCs
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ATHN’s Strategic Opportunities
• Gain and engage ATHN Affiliates
Network
Infrastructure
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Develop
electronic
database
capacity
re: database
• Build community trust
• Expand local capacity by funding
and training data managers
• Establish regional data
management structure
• Define and establish the core
dataset: bleeding and clotting
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How Will Data Flow?
Patient
HTC
HTC
Access by
Certificate Only
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Patient
Central
Server:
Secure and
Encrypted
Data
Consented
Patients Only
Non-identifiable
Consented
Limited
Dataset
HTC
Care Management (virtual HTC
safe deposit boxes
in a secure server vault)
Public Health & Research
(includes ATHN)
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ATHN’s Strategic Opportunities
Outcomes
Improvement
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Use data to
drive quality,
service,
and patient
centered
care
• Get data to clinical decision makers
• Help insure the survival of treatment
centers by demonstrating and driving
quality and service
• (Future) Explore opportunities to
provide clinical decision support tools
as components of the web
infrastructure
Can we map these opportunities to
thrombosis? How?
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ATHN’s Strategic Opportunities
• Clarify roles vis-à-vis CDC, HTRS,
Data Analysis
and Research
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Facilitate
knowledge
creation and
advocacy
MCHB re: research
• Attract research proposals to
appropriately use the database
• Publish related to our work
• Formalize relationship with the forprofit sector
These all mean something very
different in thrombosis/thrombophilia
than they do for hemophilia
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Audience participation – what are we
doing now?
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Our center uses same data tools for thrombotic disorders as we do
for bleeding disorders?
– Thrombosis
– Anticoagulation clinic
– Thrombophilia
Our center would like to do this if ATHN made it easy to do!
Our center uses same STAFF for thrombotic disorders as we do for
bleeding disorders
– Thrombosis
– Anticoagulation clinic
– Thrombophilia
We have SOME overlap of these activities, but not much
– Thrombosis consultation
– Anticoagulation clinic
– Thrombophilia
We already participate in formal thrombosis data collection for other
studies
– HTRS
– Other
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Thrombosis Data – where shall we go
from here?
• Phase I
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• Phase II
• Phase III
Structured Core Data Elements
Diagnoses? If so, which?
Medications?
Labs?
Demographics?
HTC Data Queries
UDC? Outcomes reports? Studies?
Can we facilitate the pediatric thrombosis
registry in HTRS or other ongoing projects?
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