Being Precise About Precision Medicine: What Should Value Frameworks Incorporate to Address Precision Medicine? A Report of the Personalized Precision Medicine Special Interest Group.

Precision medicine is a dynamic area embracing a diverse and increasing type of approaches that allow the targeting of new medicines, screening programs or preventive healthcare strategies, which include the use of biologic markers or complex tests driven by algorithms also potentially taking account of patient preferences. The International Society for Pharmacoeconomics and Outcome Research expanded its current work around precision medicine to (1) describe the evolving paradigm of precision medicine with examples of current and evolving applications, (2) describe key stakeholders perspectives on the value of precision medicine in their respective domains, and (3) define the core factors that should be considered in a value assessment framework for precision medicine. With the ultimate goal of improving health of well-defined patient groups, precision medicine will affect all stakeholders in the healthcare system at multiple levels spanning the individual perspective to the societal perspective. For an efficient, timely and practical precision medicine value assessment framework, it will be important to address these multiple perspectives through building consensus among the stakeholders for robust procedures and measures of value aspects, including performance of precision mechanism; aligned reimbursement processes of precision mechanism and subsequent treatment; transparent expectations for evidence requirements and study designs adequately matched to the intended use of the precision mechanism and to the smaller target patient populations; recognizing the potential range of value-generation such as ruling-in and ruling-out decisions.

Experiences and attitudes toward risk of recurrence testing in women with breast cancer: a systematic review.

Recurrence tests, such as Adjuvant! Online and Oncotype DX, can be used to determine an individual's risk of developing recurrent cancer. These technologies are useful for helping health care practitioners make treatment recommendations. With increasing use, it is necessary to consider patients' experience with and attitudes toward risk of recurrence testing. Factors such as anxiety, influence on decision making, confidence in results, and satisfaction with testing are important to consider. To understand experiences and attitudes toward risk of recurrence testing, from the perspective of women who have used these technologies following a breast cancer diagnosis. A systematic review was completed. Eight multidisciplinary electronic databases, including MEDLINE, PsycINFO, CINAHL, and ERIC, were searched from 1950 to December 17, 2012. Abstracts and full-text papers were screened for inclusion, in duplicate, based on established criteria. Recurrent themes and key concepts were identified and analyzed. One-thousand and twenty-two abstracts were retrieved, and fifty-one proceeded to full-text review. Ten studies reporting on eight populations were included in this review. Key themes that emerged from the literature include: experience with the testing process; influence testing has on treatment; and comprehension of results. The literature suggests that testing for breast cancer recurrence can have a negative impact on women; poor comprehension of test results, and anxiety/distress were the most frequently cited reasons for a negative experience. Despite these drawbacks, women consistently reported that they would recommend testing to others. The literature on this topic is limited, and heterogeneous. The available literature suggests that women are generally satisfied with risk of recurrence testing for breast cancer. Potential drawbacks of risk of recurrence testing include anxiety and comprehension of test results. Additional high-quality research on women's experiences with risk of recurrence testing for breast cancer would improve the evidence base, and would allow stronger conclusions to be drawn.