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June 26, 2013

Personalized Medicine vs Guideline-Based Medicine

Author Affiliations

Author Affiliations: Center for Cardiovascular Innovation and Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois (Dr Goldberger); and Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts (Dr Buxton).

JAMA. 2013;309(24):2559-2560. doi:10.1001/jama.2013.6629

Two philosophical approaches to the implementation of optimal health care are emerging—the use of evidence-based guidelines and the application of personalized (or “precision”) medicine. Even though both approaches have important merits, they both also can present conflicting priorities that must be reconciled before they can be best leveraged.

Evidence-based guidelines are generated based on the body of clinical data available for a particular question. The highest level of evidence assigned in a guideline is based on multiple randomized controlled clinical trials. In general, randomized clinical trials have specific inclusion and exclusion criteria designed to represent a population broad enough and sufficiently enriched to attain a requisite number of end points and demonstrate a statistically and clinically significant difference in outcome. Subgroup analyses (both those that are prespecified and other post hoc analyses) are often performed to identify characteristics within the study population that are associated with greater benefit from the intervention, with no benefit, or even with harm. Yet these analyses are accompanied by warnings that findings should be cautiously interpreted.1

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