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Showing posts from February, 2015

Let's Play Outcome Mash-up - A Clinical Trial Shortcut Classic!

Deciphering trial outcomes can be a tricky business. As if many measures aren't hard enough to make sense of on their own, they are often combined in a complex maneuver called a composite endpoint (CEP) or composite outcome. The composite is treated as a single outcome. And journalists often phrase these outcomes in ways that give the impression that each of the separate components has improved. Here's an example from the  New York Times , reporting on the results of a major trial from the last American Heart Association conference: "There were 6.4% fewer cardiac events - heart disease deaths, heart attacks, strokes, bypass surgeries, stent insertions and hospitalization for severe chest pain..." That individual statement sounds like the drug reduced deaths, bypasses, stents, and hospitalization for unstable angina, doesn't it? But it didn't. The modest effect was on non-fatal heart attacks and stroke only.* CEPs are increasingly common: by 2007,  well over a