How to read the publication of a randomized controlled trial

Traditional evidence-based medicine a la Sackett has it that you should consider a couple of aspects about a randomized controlled trial, before you believe it. Using the chapter on RCTs in the User’s Guide and the SPARCL trial in the NEJM we discover quite a lot of flaws in this not quite so new trial, that spawned a lot of controversy about the bleeding complications of high dose statins – a topic on it’s own.

On my hidden agenda I wanted to also sharpen the minds about the disadvantages of large-scale RCTs. While I would not go as far as James Penston in his book or one of his articles to totally condemn them (hey, they are still the best – after n=1 trials – we’ve got in terms of research), it is worthwhile to understand why phase 3 RCTs are more an economic than a medical undertaking. So go on and read one of his articles, say this.

Quite curiously, we did not go into this topic as far as I would have wished and instead focused on p-values, confidence intervals and frequentist statistics – a topic we have to deal with again in the future (after I have read up on Fisher vs. Neyman-Pearson).

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