An Update… CDC Surveillance Project on Bleeding Disorders

1. Diane Aschman Administrative PI Marilyn Manco-Johnson Scientific PI An Update…CDC Surveillance Project onBleeding Disorders

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 monthly Tuesday Becky Dudley Chair Meets weekly Friday M. 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 HTC Population Profile Registry for Bleeding Surveillance • 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

8. Surveillance Components: 2 Parts HTC Population Profile 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

12. HTC Population DataData Elements Originally Proposed by CDC after feedback • 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

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. Surveillance Components: 2 Parts HTC Population Profile 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

21. Diane Aschman Announcing…ATHNdataset A Growing Resource for Bleeding Disorders Community

22. AnnouncingATHNdataset: 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 Patients choose to “opt in” by signing a patient authorization - 9240 patients are in! No special lab tests or clinic visits Patient identity is protected with a unique patient identifier 9240

25. Patient Authorizations, All Regions

26. Sample Data Fields Applicable to Cohort Studies in WebTracker & ATHNadvoy Standardized using SNOMED CT, LOINC and First DataBank’s NDDF * Core data element

27. What’s not in the ATHNdataset? • 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 * 29 unknown

30. Patients By Primary Diagnosis (9,240 Authorized Patients as of March 31, 2012) VWD FVIII

31. Patient Disease Severity & Inhibitors (3,588 FVIII Deficiency Authorized Patients as of March 31, 2012) 9.92%

32. Prophylaxis Across Age Groups in Factor VIII Deficiency Patients* ATHNdataset as of March 31, 2012 (n=3588) 44% *unaudited

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

34. Dashboard Report Tracks HTC Data Capture and Patient Authorizations

35. 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