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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