Should we give steroids to patients with OHCA and refractory
shock? This is a decent research question.
If one wants to know the truth, then the double-blind placebo controlled RCT is the absolute pinnacle
of research.
The overall methods of this paper are great. Of course no
papers are perfect and there were some issues but...
There was a fatal flaw.
It was only powered to
include 50 patients! You have got to be kidding me.
It does not take a masters in biostatistics to know that
such small numbers will only ever find
huge changes in treatment effect. The likelihood of a type II error (false negative
study) is massive.
(Just in case you were wondering, they found no difference if patients were given steroids or not)
This was going to be
a negative study before they ever started. What were they thinking...?
Sometimes I wish I had a time machine so I could go back and shake these
people.
Perhaps I shouldn’t be so critical. Feasibility of such a
study is a major problem. These patients are not common and recruitment would
have been very challenging. But most researchers anticipate this and choose
other study designs and/or make other efforts & compromises. Why conduct
research that you know will be flawed and a waste of time?
What should we conclude?
Absolutely nothing. Grumphfpfff...
But there is a good
lesson to researchers and to those learning critical appraisal of the
literature. Do your homework before you start. Choose a research question and
study design that is feasible and has the potential for success.
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