An article by the TOPPS investigators in the May 9th NEJM is very useful to remind us not to believe everything we read, to always check our premises, and that some data are so dependent on the perspective from which they're interpreted or the method or stipulations of analysis that they can be used to support just about any viewpoint.
- The interpretation of the trial hinges critically on the premises of the study and the endpoint chosen: does prevention of WHO Grade 2 (or greater) bleeding make sense to you?
- If you accept the primary endpoint as valid and relevant to practice, does a margin of non-inferiority (delta) of 10% or 15% satisfy you?
- Are you OK with 90% confidence intervals and adjusted analyses and intention-to-treat analyses in a non-inferiority trial?
- Are you willing to declare superiority under less stringent criteria than you would have declared non-inferiority? (See this Letter to the Editor of JAMA regarding the recent CONSORT statement revision.)