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Commentary |

Limitations of Applying Summary Results of Clinical Trials to Individual Patients:  The Need for Risk Stratification

David M. Kent, MD, MS; Rodney A. Hayward, MD
JAMA. 2007;298(10):1209-1212. doi:10.1001/jama.298.10.1209.
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There is growing awareness that the results of randomized clinical trials might not apply in a straightforward way to individual patients, even those within the trial. Although randomization theoretically ensures the comparability of treatment groups overall, there remain important differences between individuals in each treatment group that can dramatically affect the likelihood of benefiting from or being harmed by a therapy.14 Averaging effects across such different patients can give misleading results to physicians who care for individual, not average, patients.

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Figure. Population Distribution of Baseline Outcome Risk, Outcome Risk With Treatment, and Relative Risk Reduction
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