RMRS_SOW_hpv_GW_HSIL.docx

Statement of Work

Use of existing longitudinal data to evaluate HPV vaccine effectiveness on HPV-associated genital warts and early cervical disease: a feasibility study

I. BACKGROUND

Prophylactic vaccines against genital human papillomavirus (HPV) types that can cause HPV-associated cancers, precancerous lesions, and genital warts have been available in the U.S. since 2007. HPV vaccines are a milestone in cancer control efforts, with potential to significantly decrease the incidence of cervical and other cancers due to HPV, the most common sexually transmitted infection in the United States. Demonstrating population impact of HPV vaccines is crucial to guide national policies and programs, but measuring the impact on invasive cervical cancers will likely take several decades due to the slow rate of development. Genital warts and cervical precancer lesions such as high grade squamous epithelial neoplasia (HSIL) are also caused by HPV types targeted by the quadrivalent vaccine, but take less time to develop and can provide earlier evidence of vaccine impact.

Much effort has been dedicated to identifying available data to measure HPV vaccine impact and effectiveness on early cervical outcomes in the United States. Because neither genital warts nor HPV-associated cervical precancers are nationally reportable, complete vaccination history is not readily available, and data systems that can link vaccination status to related outcomes have not been in place long enough to include outcomes that may take years to develop, options are limited. In addition, there are even fewer data sources that capture an entire community population (as opposed to a managed care population).

The Regenstrief Medical Record System (RMRS) is one of the largest (660 million distinct observations), longest operating (continuously since 1973) and best medical record systems in the world, and the only functioning population-based health information exchange (HIE) in the United States. The RMRS provides a unique opportunity to establish population-based cohorts within a well-established health system to evaluate HPV vaccine impact in a cost-effective manner.

II. PURPOSE

To conduct a feasibility study of using population-based electronic medical record data collected by RMRS to examine completion of HPV vaccination and to compare rates of genital warts and cervical high grade squamous intraepithelial (HSIL) lesions by HPV vaccination status in an observational cohort.

III. SCOPE OF WORK

The vendor will provide all data and labor required to complete the tasks outlined below.

IV. TASKS TO BE PERFORMED

The vendor shall perform the following tasks to complete the required data analysis:

A. Develop and submit to CDC, for review and approval, a complete data analysis plan related to the objectives described above under “Purpose”.

B. Submit protocol for data extraction and obtain IRB approval.

C. Query and link data systems to extract relevant data to achieve research objectives.

D. Plan and execute the analyses.

E. Prepare tables and figures summarizing findings F. Prepare comprehensive report of study findings.

V. GOVERNMENT FURNISHED MATERIALS

N/A

VI. PERIOD OF PERFORMANCE

The period of performance shall commence upon award of a purchase order and shall continue through the next 15 months and completed no later than March 15, 2014.

VII. DELIVERABLES

All electronic files should be delivered in MS Word format and provided via e-mail.

Preliminary analysis plan and draft IRB protocol.

November 30, 2012

Final analysis plan and protocol incorporating CDC input.

January 15, 2013

IRB approved protocol.

February 15, 2013

Report of preliminary results, including summary tables and figures.

July 31, 2013