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

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

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

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

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

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 (2000-2005) 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

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

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

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

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, 078.10-19) Chart abstraction to validate Genital wart-specific variables in sites using “pull down menus”

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

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 18-22 year-olds

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

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

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