an update… cdc surveillance project on bleeding disorders

1

An Update…CDC Surveillance Project onBleeding Disorders

Diane Aschman

Administrative PI

Marilyn Manco-Johnson

Scientific PI

2

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

3

National Surveillance Program Organization

Meets q 2 weeks Wednesday

Meredith Oakley CDC Project Officer

Meets monthlyTuesday

Becky DudleyChair

Meets weeklyFridayM. Manco-Johnson Scientific PI

4

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

5

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

6

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

30% Hematologists; 50% Nursing; 20% Others

7

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


Registry for Bleeding Surveillance


8






9

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

10

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

11

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

12

HTC Population DataData Elements Originally Proposed by CDC after feedback

13

HTC Population Profile: Next Steps

14

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

15

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

16

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

17






18

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

19

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

20

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

21

Announcing…ATHNdataset A Growing Resource for Bleeding Disorders Community

Diane Aschman

22

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

23

Infrastructure Rollout Status September 2010 – March 2012

24

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

25

Patient Authorizations, All Regions

26

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

27

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)

28

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

29

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

30

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

FVIII

VWD

32

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

9.92%

33

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

44%

*unaudited

34

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

35

Dashboard Report Tracks HTC Data Capture and Patient Authorizations

36

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

an update… cdc surveillance project on bleeding disorders

Documents