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Thrombosis/thrombophilia patients captured at HTCs participating in ATHN

Ellis J. Neufeld MD, PhDDirector, Boston Hemophilia Center Director, Thrombosis Service, Children’s Hospital BostonAssociate Professor of Pediatrics, Harvard Medical School

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Topics

• How does the over-arching ATHN structure allow 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

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Shared and distinct characteristics between bleeding disorders and thrombosis, clinical research, public health• 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

Network Infrastructure

Data Management

Public Health and Safety

Outcomes Improvement

Data Analysis and Research

Data safety, back-up, and portability

Support surveillance and patient safety

Use data to drive quality, service, and patient centered care

Facilitate knowledge creation and advocacy

Develop electronic database capacity

(In principle, each of these five elements can apply to thrombosis and thrombophilia)

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HTC Needs Assessment

•eSurvey on ATHN website– 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

Focus on thrombosis/thrombophilia responses

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Currently Using Lab Tracker

Users

Non Users

(Based on 79 Respondents)

We may be hearing back mostly from the choir

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Data Routinely Computerized in Lab Tracker

0 20 40 60 80 100

Contacts

Diagnoses

Surgeries

Med - Coag

Meds- Other

Labs

Infusion records

% of HTCs

(Based on 78 Respondents)

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Patient Types Entered into Lab Tracker

020406080

100

Hemophili

aVW

D

Other

Ble

edin

g

Throm

botic

Plate

let D

isord

ers

Carrie

rs

Other

% of HTC Lab Tracker Users

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Thrombosis Patients

(Based on the initial 78 respondents)

0%

20%

40%

60%

80%

100%

Where Are Patients Seen?

Within A Separate Anti-Coag/Thrombosis Clinic/Other

Within HTC

Audience participation – what does “within hemophilia Ctr mean to you?

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Patients with Thrombotic Disorder at HTC

0

2468

101214161820

#HTC

1-50

51-99

100-199

200-299

>300

51 of 78 HTCs reporting

This adds up to AT LEAST 6000 patients “without even trying”. But 2/3 of these at 15 sites

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Types of Thrombosis Patients Seen

0

20

40

60

80

100

Peds wThombosis

Peds wHereditary

Thrombosis

Adults wThrombosis

Adults wHereditary

Thrombosis

% of HTCsThese categories are very different, but not

mutually exclusive

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ATHN’s Strategic Opportunities

Network Infrastructure

Develop electronic database capacity

• Gain and engage ATHN Affiliates 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?

HTC

HTC

HTC

CentralServer:

Secure and Encrypted

Data

CentralServer:

Secure and Encrypted

Data

Non-identifiableConsented

Limited Dataset

Non-identifiableConsented

Limited Dataset

Patient

Patient

ConsentedPatients OnlyAccess by

Certificate Only

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

•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

Outcomes Improvement

Use data to drive quality, service, and patient centered care

Can we map these opportunities to thrombosis? How?

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ATHN’s Strategic Opportunities

•Clarify roles vis-à-vis CDC, HTRS, MCHB re: research

•Attract research proposals to appropriately use the database

•Publish related to our work

•Formalize relationship with the for-profit sector

Data Analysis and Research

Facilitate knowledge creation and advocacy

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?• 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 Structured Core Data Elements

Diagnoses? If so, which?

Medications?

Labs?

Demographics?

• Phase II HTC Data Queries

• Phase III UDC? Outcomes reports? Studies?

Can we facilitate the pediatric thrombosis registry in HTRS or other ongoing projects?