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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
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
HTC Population Profile
Registry for Bleeding Surveillance
Registry for Bleeding Surveillance
8
Surveillance Components: 2 Parts
HTC Population Profile
HTC Population Profile
Registry for Bleeding Surveillance
Registry for Bleeding Surveillance
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
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
Surveillance Components: 2 Parts
HTC Population Profile
HTC Population Profile
Registry for Bleeding Surveillance
Registry for Bleeding Surveillance
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
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
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
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
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