Epidemiology Assessment SOW.docx

Breast Cancer Concern Investigation Protocol

WRJVA Medical Center Statement of Work for a Phase II Assessment of a possible breast cancer cluster in Building 8, (Lakes).

Phase II: Assessment The purpose of this phase assessment is to determine if the reported breast cancer concerns represent a true cancer cluster based on the presence of a statistically significant excess of cancer. Once the investigation is awarded, the study shall be completed within six weeks to include a full report to the WRJ VA Medical Center.

1. Investigator establishes a standard set of criteria to help WRJ Medical Center identify all cases connected to Building 8(Lakes) that should be included in the cluster analyses including:

· Cancer type

· Residence at the time of diagnosis

· Year of diagnosis

· Age at diagnosis

· Sex

2. Investigator conducts a review of the Vermont State Cancer Registry (VTSCR) data to:

a. Analyze trends in age at diagnosis for identified cancers

i. Verify that average age of diagnosis occurs within the expected age group

ii. Determine number of outliers (cases diagnosed at a much younger or older age than expected)

b. Calculate expected number of cases based on cancer rate(s) in a similar comparison population

i. Calculate appropriate population denominators for area under investigation

ii. Calculate census-based estimates of the ratio of the area population to total VT population

c. Compare the observed vs. expected number of cancer cases

i. Determine if significant differences exist between local area and comparison population rates

ii. Calculate 95% confidence intervals (CIs) for area-specific rates

iii. Conduct test(s) to determine whether or not differences in area-specific rates and the state-level rate are statistically significant.

iv. If area-specific rates are significantly higher than state rates, calculate age, race, and gender-specific incidence rates for the area under investigation

v. Calculate standardized incidence ratios (SIRs) for cancers that are significantly elevated at the area-specific level compared to the state rate

d. In instances where the population is large enough the WRJVA Medical Center will calculate and compare age-adjusted incidence rates between the area under investigation and relevant comparison population

3. Investigator convenes the Cancer Concern Review Team (CCRT) with membership from the VT Department of Health and Human Services, the VT State Cancer Registry and other agencies (VT Department of Environmental Services, Centers for Disease Control and Prevention, and Environmental Protection Agency) as needed to make a recommendation on next steps considering the following:

· Are there enough cases and a large enough population for statistical stability?

· Review confidence intervals to determine whether a significant SIR could be related to chance

· Are there potentially environmental contaminants present which are known to be associated with the cancer under investigation?

· Are there additional cases that could be related to the already identified cases?

· Has there been an increase in the incidence rate of the cancer(s) over time?

· How many excess cases are there?

· Are the demographic characteristics of cases unusual for the type of cancer?

· A full report from the hired firm will be provided the WRJVAMC.

WRJ Medical facility will share the conclusion of the assessment and the next steps with the current stakeholders.