This study reminds me of a key event in my life.
My eyes were opened when I looked into the details of the non-inferiority study comparing Rocephin and Amoxicillin for otitis media. Patients were recruited in the winter, treated then, and examined in June as an endpoint. JUNE? Months later? Of course both treatments had high success rates and there was little difference between them. I had been trained in industry to design experiments to distinguish between two methods. My pension depended on the company being profitable, so since I was working on production methods, obfuscation was detrimental to profits. But those authors appear to have designed the study to avoid detection of a difference. They were devious enough to devise a way of profiting based on misleading physicians. And it worked. I needed to lose some innocence if I were to survive in medicine.
So, in looking at the Dex v Pred article used for the SGEM, I would say this article suffers the same taint.
There was no difference in mean PRAM scores at day four between the dexamethasone and prednisolone groups.
I agree with the result of the primary outcome.
A single dose of dexamethasone is non-inferior to a three-day course of oral prednisolone in the treatment of children with an acute asthma exacerbation presenting to the emergency department.
I disagree with the conclusion reached based on the result. The study chose a primary outcome which is inadequate to support the conclusion.
If I am so short of breath that I come to an ER, the outcomes I would be interested in would be the amount of suffering occurring 4 hours later, 1 day later, and 2 days later. How I feel on Thanksgiving day two years later is immaterial.
The study showed the 3 times as many dexamethasone patients needed more steroids. (13.1 vs 4.2%) The NNH is 11. The magnitude of that harm is unclear. It is not lethal. But many extra children remained short of breath 1-3 days after being treated with Dex. That is not a non-inferior treatment.
I only read the website. I did not listen to the Podcast since that is 24 minutes long, which is far more than I spent reading the article and sending it to the virtual trash can where it belongs.
You need a more skeptical skeptic.
Kevin Powell MD PhD FAAP
Saint Louis, MO
From: Pediatric Emergency Medicine Discussion List [mailto:[log in to unmask]] On Behalf Of Michael Falk
Sent: Monday, November 13, 2017 10:59 AM
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Subject: Re: We wuld love feedback from folks!
Just recorded this podcast with Ken Milne at Skeptic's Guide to EM. Please listen and feel free to leave comments or feedback! And please share with me any thoughts or ideas folks have for other podcast.
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