TY - JOUR T1 - Composite end points in randomized trials: There is no free lunch AU - Tomlinson G, Detsky AS Y1 - 2010/01/20 N1 - 10.1001/jama.2009.2017 JO - JAMA SP - 267 EP - 268 VL - 303 IS - 3 N2 - An article reporting the results of a randomized trial contained the following sentence: “This large, prospective, blinded international clinical trial shows that 8 mg of rosiglitazone daily, together with lifestyle recommendations, substantially reduces the risk of diabetes or death by 60% in individuals at high risk for diabetes.”1 Taken alone, this statement offers little guidance to a clinician who is prescribing the drug, because death and diabetes are quite far apart in the spectrum of severity. Two questions arise: Was there a 60% reduction in both death and diabetes? Are the two outcomes just as likely to occur? To make a decision, a clinician needs more information on the individual components, and the article in question does indeed provide this information. But after reading the entire report, the clinician may ask a third question: Why did the clinical trial use the primary outcome of diabetes or death? SN - 0098-7484 M3 - doi: 10.1001/jama.2009.2017 UR - http://dx.doi.org/10.1001/jama.2009.2017 ER -