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An Update…CDC Surveillance Project onBleeding Disorders

Diane Aschman

Administrative PI

Marilyn Manco-Johnson

Scientific PI

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Goals of the Surveillance

• Provide descriptive knowledge about the demographics, diagnoses and health service utilization of populations with bleeding disorders and venous thromboembolism receiving care at HTCs

• Monitor health indicators among populations with bleeding disorders

– Assess trends over time

– Measure rates of, and risk factors for, complications

– Identify high risk populations for prevention

– Identify issues that require research

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National Surveillance Program Organization

Meets q 2 weeks Wednesday

Meredith Oakley CDC Project Officer

Meets monthlyTuesday

Becky DudleyChair

Meets weeklyFridayM. Manco-Johnson Scientific PI

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HTC Subaward Status – 97 signed as of 4/22/12

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Thank You for Signing On!

Region VI

• Gulf States

• Louisiana

• Arkansas

• Fort Worth

• South Texas

• Texas Children’s

Region VII

• Children’s Mercy

• Iowa

• John Bouhasin

• U of Missouri

• U of Nebraska

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Surveillance Design: HTC Grass Root Input 124 Respondents from 60 HTCs to the Online Survey

30% Hematologists; 50% Nursing; 20% Others

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Surveillance Components: 2 Parts

• Individual level data (not aggregate)

• De-identified (all 18 identifiers removed)

• Description of population from which registry data is drawn (vs. all patients served)

• No patient authorization required by CDC

• All or a subset of patients with eligible disorders

• Will require blood sample• Patient authorization

anticipated

HTC Population Profile

HTC Population Profile

Registry for Bleeding Surveillance

Registry for Bleeding Surveillance

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Surveillance Components: 2 Parts

HTC Population Profile

HTC Population Profile

Registry for Bleeding Surveillance

Registry for Bleeding Surveillance

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HTC Population Profile: Enrollment All HTC Patients Meeting Entry Criteria

Inclusion Criteria

•Hereditary disorders– Factor VIII /IX def

– VWD

– Rare bleeding

– Platelet (females)

•DVT or PE

•1+ clinic/telemed encounter w/i year

Exclusion Criteria

•Other or Non-hematologic disorders

•Males with platelet disorders

•Acquired bleeding disorders

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HTC Population Profile: Measures As Currently Proposed

• Race

• Ethnicity

• Gender

• Year of Birth

• Zip Code

• Insurance Status

• Year of Visit to HTC

• Primary Bleeding or Clotting Disorder

• Baseline factor level

• VTE Occurrence

• HCV Status

• HIV Status

• Unique Identifier

• HTC Identifier

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HTC Population DataData Elements Originally Proposed by CDC

• Race• Ethnicity• Year of Birth• Zip code• Diagnosis (with

severity or type)• Age of diagnosis• Disability status• HCV/ HIV status

• Visits to HTC in this year• Year of last visit• Insurance type – primary• Insurance type –

secondary• Who referred patient to

HTC• Purpose of most recent

visit• Unique identifier

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HTC Population DataData Elements Originally Proposed by CDC after feedback

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HTC Population Profile: Next Steps

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Step 1: Finalize Data Elements

• Demographic and basic diagnosis info

– Similar to HDS

– Most data elements overlap with ATHNdataset core

– De-identified so no patient consent

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Step 2: Create New Data Forms

• 90 days following final data elements

• Data currently in WebTracker will pre-fill new surveillance forms

• Can input data now

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Step 3: Train HTCs

• Phase 1: Getting Started – ATHNreport

• Phase 2: Regional Meetings

• Phase 3: Webinars – w/i 75-90 days

• Phase 4: Ongoing support

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Surveillance Components: 2 Parts

HTC Population Profile

HTC Population Profile

Registry for Bleeding Surveillance

Registry for Bleeding Surveillance

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Registry: Enrollment Patients must be enrolled in the HTC Population Profile

Inclusion Criteria

•Hereditary disorders– Factor VIII /IX def

– VWD

– Rare bleeding

– Platelet (females)

•1+ clinic/telemed encounter w/i year

Exclusion Criteria

•Other or Non-hematologic disorders

•Males with platelet disorders

•Acquired bleeding disorders

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Registry: Data Elements

• Being defined by Science Committee in collaboration with CDC

• Striving for consistency across disorders where ever possible

• Narrowing down to most salient measures

– Intracranial hemorrhage - CVAD

– Inhibitors - Genetics/Family HX

– Joint disease - Healthy Life-style

– Product use

– Prophylaxis

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We Need & Want Your Involvement

• Weigh in on Registry Data Elements

– Contact regional leadership

– Review at www.htcnetwork.org

• Start amassing HTC Population Profile data

• Keep up to date

– ATHNreport

– Trainings

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Announcing…ATHNdataset A Growing Resource for Bleeding Disorders Community

Diane Aschman

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Announcing ATHNdataset: A Growing Resource

• Created by American Thrombosis and Hemostasis Network (ATHN) in collaboration with its 133 affiliated hemophilia treatment centers

• Brings together standardized demographic and clinical data into one national dataset

• Is a “Limited Data Set” as defined by Privacy Rule

– Stripped of 16 specified direct identifiers

– Used or disclosed for public health, research or health care operations

– Disclosure covered by data use agreements

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Infrastructure Rollout Status September 2010 – March 2012

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ATHNdataset is Growing Patient authorizations as of March 31, 2012

9240

Patients choose to “opt in” by signing a patient

authorization - 9240 patients are in!

No special lab tests or clinic visits

Patient identity is protectedwith a unique patient identifier

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Patient Authorizations, All Regions

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Sample Data Fields Applicable to Cohort Studies in WebTracker & ATHNadvoy

DEMOGRAPHICS CLINICAL INFO OUTCOMES

Date of birth* Primary*/other diagnoses 1st*/all Bleed events

Race* Date of diagnosis* 1st Bleed location*

Ethnicity* Disease severity* Prophylaxis used

Gender* Factor levels* Treatments used

Age- 1st home infusion* Treatments prescribed* Date of death*

Marital status Age at 1st exposure* Cause of death*

Education level Surgeries/procedures* Anemia

Language* Inhibitor status*

Payer type* Weight/Height*

Co-morbidities-HIV, Hep*

Molecular defect

Standardized using SNOMED CT, LOINC and First DataBank’s NDDF* Core data element

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What’s not in the ATHNdataset?

Identifiers NOT in

the ATHNdataset, which

is a limited data set

Name Social security # Certificate/license #

Postal address Medical records # Vehicle ID/serial#

Telephone # Health plan beneficiary # Device ID/serial #

Fax # Account # Web URL

Email address Full faced photos IP address

Biometric identifiers

• Data of patients who did not sign the authorization

• 16 identifiers excluded from a limited data set (HIPAA)

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Why opt in? The Power is in the Numbers – A Large Pool of Data is Needed

• Many critical questions need answers

– Scientific, public health, policy

– ATHNdataset supports research

• Also supports delivery of care, public health reporting, outcomes assessment and advocacy

• Same data enables HTC to create your ATHNready Personal Health Report for emergency preparedness

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ATHNdataset Demographics as of March 31, 2012

Authorized Patients(n=9,240)

# of Patients

% of Patients

SEX Males 6,329 68.5% Females 2,911 31.5% AGE < 18 years 4,676 50.6% 18+ years 4,564 49.4% RACE* White 7,808 84.5% Non-White 1,408 15.2% ETHNICITY* Hispanic or Latino 1,063 11.5% Non-Hispanic or Latino 8,148 88.2%

* 29 unknown

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Patients By Primary Diagnosis (9,240 Authorized Patients as of March 31, 2012)

FVIII

VWD

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Patient Disease Severity & Inhibitors (3,588 FVIII Deficiency Authorized Patients as of March 31, 2012)

9.92%

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Prophylaxis Across Age Groups in Factor VIII Deficiency Patients* ATHNdataset as of March 31, 2012 (n=3588)

44%

*unaudited

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Payer Type: Primary Factor Payer (2,733 of 9,240 Authorized Patients as of March 31, 2012)

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Dashboard Report Tracks HTC Data Capture and Patient Authorizations

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ATHNdatasetPatient Registry with Standard Building Blocks…Multiple Uses

• HTC patient profiles, accessible/reportable data

• Comparisons with peers or best practices

• Eligibility screening, cohort tracking, hypothesis testing

• Combining core and enriched data elements