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Carl Heneghan

👤 Person
926 total appearances

Appearances Over Time

Podcast Appearances

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

How's that for a list?

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

Anyhow, just for EBM nerds out there, there is something that might be of interest to people.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

There was a paper some way back in the BMJ about the Zelen design.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

Ah, yeah, you see, you're now on your way to... I think you're showing off, Carl.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

Um...

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

It's basically to account for this idea of patient preference in the designer trials.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

And what Zelen Design does is randomise people before consent to actually see what they will actually do when they get assigned to the treatment or not.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

and it tries to account for what would be the impact on patient preference.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

And some people have said, well, it's unethical to do that.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

But often a problem is you go into a trial, you get consented, and then people, randomised particularly in surgery, say you're not going to get the surgery, and then they withdraw.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

And you have a super, you have a big problem then in balancing the arms.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

So what Zelen does, and there's a paper back in the BMJ in 98, is randomise you before consent to see what will actually happen.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

Interesting issue.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

Yeah, so look, I think this is a really interesting issue.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

So there are a couple of things that come to mind.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

There's a paper by Johnny in Ardis that said you can overcome small effects with any introduction of bias.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

So one of the most important aspects about any trial outcome is the size of effect matters.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

So if the effect is tiny...

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

You really worry about any introduction of bias.

Talk Evidence
Talk Evidence - Sepsis, talc and blindsided by blinding

The second issue that what comes with bias is we're sort of railing now against this sort of formulaic approach, which we've introduced over the last 15, 20 years, where the quality of studies comes down to three or four measures.