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Response to USPSTF Research Plan for BRCA Testing

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Read the USPSTF's draft research plan on Genetic Risk Assessment and BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility

Read our full response to the USPSTF's draft.

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The United States Preventive Services Task Force (USPSTF) is an independent volunteer panel of experts in prevention and evidence-based medicine which conducts scientific reviews of a broad range of clinical preventive services (including screening, counseling, and the use of preventive medications) and develops recommendations on the effectiveness of these services.

Recently, the USPSTF reached out to FORCE and other consumer groups, health care providers, researchers, and individuals for input into their approach to reviewing the current research literature and updating their recommendations on risk assessment and risk management in high-risk individuals.

The full USPSTF's draft research plan can be viewed here.

FORCE's recommendations

The following is a summary of our recommendations to the USPSTF. You can read our full comments with justification for each suggestion here.

  • We recommend extending this evaluation to include cancer survivors who have a diagnosis of a BRCAassociated cancer.
  • We recommend including BRCA-associated cancer outcomes beyond breast and ovarian cancer to other cancers known to be associated with the syndrome.
  • We recommend extending this evaluation to include men.
  • We recommend a more specific definition of what constitutes "risk assessment" and "pretesting genetic counseling."
  • We recommend changing the analytic framework to include that people of certain ethnic backgrounds and particularly people of Ashkenazi Jewish descent are at increased risk for a mutation. We suggest this information be added as an important criterion to be identified prior to formal risk assessment.
  • For the purposes of evaluating Key Question 2c), we recommend extending this evaluation to any person who meets genetic evaluation and testing guidelines, not just women with a family history of cancer.
  • We suggest adding post-testing genetic counseling as an important and evaluable step separate from (and after) genetic testing in the framework.
  • We suggest evaluating separately outcomes of BRCA positive, “true negative” (positive mutation in family
    and member tests negative), “uninformative negative” (no identified mutation in the family) and variant of uncertain significance. Each test result has a different implication and recommended follow-up process that is distinct from the other result categories but important in evaluating the benefits/risk ratio of testing.
  • We recommend that when the task force evaluates outcomes of intervention strategies, consideration is given to the fact that clinical trials or other studies of most of the primary risk reduction strategies (prophylactic surgery, for example) cannot be undertaken using randomized trials. When rating the strength of the evidence it is important to consider the limitations of research trial design for these interventions.
  • We recommend explicitly including long term sequelae of prophylactic surgery (e.g., the long term consequences of surgical menopause including bone density loss and heart disease risk) in Key Question 5).
  • We recommend including oral contraceptives in the evaluation of prevention interventions for ovarian cancer.
Page updated 04/02/12

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