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Development and Testing of a Decision Aid for Unaffected Women with a BRCA1 or BRCA2 Mutation.

For women who are unaffected carriers of a pathogenic BRCA mutation, cancer risk management requires ongoing education, counseling, and support from an interdisciplinary team of medical specialists, genetic counselors, and nurses specializing in genomics. The purpose of this study was to develop and pilot test an educational, patient-focused decision aid to facilitate shared decision making. A steering committee developed the prototype aid after an extensive review of the literature. The aid was designed at the ninth-grade reading level, to be consistent with internationally accepted clinical guidelines and inclusive of all risk management options and psychosocial issues important to cancer risk management decision making. The aid was tested with 23 participants: eight experts and 15 end users. Eleven survey items were asked related to organization, clarity, usefulness, comprehensiveness, ease of understanding, and relevance to the cancer risk management decision-making process. Mean scores were 3 or higher on Likert scales of 1-4 (high) for each of the 11 items. Two open-ended questions elicited general comments and suggestions for additions, deletions, or revisions to the decision aid. The steering committee made final revisions to the aid based on participant feedback and committee consensus.

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