1. National STD Prevention Conference
Vaccine Safety Datalink (VSD) Project to Monitor HPV-related Outcomes and HPV Types
Eileen Dunne MD, MPH
Lauri Markowitz, MD
National STD Prevention Conference
March 11, 2008
The findings and conclusions in this report are those of the author(s) and do not
necessarily represent the official position of the Centers for Disease Control and Prevention

2. The Vaccine Safety Datalink (VSD): Background
Large database that collects medical and vaccine information > 5.5 million people annually
% US Population enrolled in 2005 (estimate)
<18 yrs of age: 4%
≥18 yrs of age: 1.5%
Collaborative project: CDC and 8 managed care organizations (MCOs)
The main purpose: evaluation vaccine safety

3. VSD Sites: 2007 Group Health Cooperative Health Partners
Northwest Kaiser Permanente
Health Partners
Harvard Pilgrim
Marshfield Clinic
No. CA Kaiser Permanente
Kaiser Permanente Colorado
So. CA Kaiser Permanente
CDC
= Infants, children, adolescents under 18 (Marshfield collecting adult data for HPV study)
= All ages

4. MCO Administrative Data Sources
Hospital discharge diagnosis codes
Ambulatory visit diagnosis codes
Enrollment and demographics
VSD Data Extraction
Birth and death certificate information
Immunizations

5. HPV associated outcomes in VSD
Purpose: To assess HPV-associated outcomes in order to measure vaccine impact
Existing administrative data augmented with HPV-associated outcomes
Collaborative project between investigators at Immunization Safety Office (ISO) and DSTD
Funding from DSTD, NVPO, NIH
3 sites: Marshfield, NW Kaiser, NC Kaiser

6. Objectives
To develop data infrastructure within VSD to evaluate HPV-associated outcomes (cervical cancer precursors, genital warts, other genital cancer precursors)
Evaluate HPV-associated outcomes at baseline before ( ) and after vaccine implementation
To evaluate HPV types in cervical specimens
Evaluate 6000 cytology specimens/site, and 250 CIN 2/3 specimens at baseline and after vaccine implementation

7. Populations and Outcomes
11-30 year-old girls/women
Outcomes: cervical, vulvar, vaginal precancers, genital warts, RRP
11-30 year-old boys/men
Outcomes: genital warts, RRP

8. Methods
Existing VSD files will be expanded to include relevant information that describes HPV associated outcomes
These additional datafiles include:
Laboratory file (Outcomes from Biopsy/Paps)
Procedure file (CPT)
Additional ICD-9 codes for adult data

9. VSD Cycle Files Additions for HPV outcomes
Patient
Characteristics and Demographics
(Enrollment, Birth Certificates, Census)
Health
Outcomes
(Hospitalizations,
ER visits,
Outpatient visits)
ICD-9, CPT, site specific info on
HPV associated outcomes
Vaccination
Records
(Vaccine type,
Date of Vaccination, Manufacturer, Lot #, Injection Site)
Laboratory Files
Linked by Study IDs

10. HPV Study Outcomes and data sources
Cervical outcomes
Laboratory data collected electronically
Cytology results (ASC-US, ASC-H, LSIL, HSIL, carcinoma) and histology results (CIN I, II, III, AGUS, adencarcinoma, squamous cell carcinoma)
ICD-9 codes
Anogenital warts
ICD-9 (078.11, )
Chart abstraction to validate
Genital wart-specific variables in sites using “pull down menus”

11. HPV Study Outcomes and data sources: other
RRP, Vulvar/Vaginal outcomes
ICD-9 codes

12. VSD Strengths/Limitations
Data available from multiple geographic locations
Vaccine information validated
Flexibility in data elements as these are routinely collected administrative data
Limitations
Not a representative sample of the US population
Limitations in MCO retention in year-olds

13. The Vaccine Safety Datalink Summary
Could provide accessible and flexible data for measuring impact of HPV vaccine on HPV-associated diseases/conditions
Provides valid vaccine information
Allows for site specific evaluations (chart abstraction, site specific data) to address questions about administrative data
Evaluation ongoing to determine if VSD will be a good source of data for monitoring impact of HPV vaccine
Baseline data will be available in late 2008

14. Acknowledgments CDC Julianne Gee Lauri Markowitz Elizabeth Unger
Eric Weintraub
Sophia Greer
Suzanne Powell
NW Kaiser
Allison Naleway
Sheila Weinmann
Karen Riedlinger
NC Kaiser
Nicola Klein
Roger Baxter
Michael Silverberg
Ned Lewis
Marshfield Clinic
Jim Donahue
Jeremy McCauley

15. Status of activities
Administrative data: sites are currently programming to collect ICD-9 and laboratory files
First data runs will be mid-year
HPV typing data: 2 sites are sending specimens
First evaluations of HPV types associated with cervical specimens will be early 2009