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This study is talking about two groups, one with a target INR of 2.0-2.5 and the other with a target INR of 2.5-3.5. The higher dose is the current standard dose.

The outcomes were extremely close group to group and it looks like the Confidence Interval was greater than 1.5%, so the study was not adequately powered to have confidence of non inferiority. Is that interpretation correct? Obviously the difference in the groups was not large, but it reads to me that they couldn't be sure it was close enough to not be worse with the lower dose, therefore they can't eliminate the possibility that low dose treatment is more dangerous than current dose? If so, would they do another study or would that basically amount to p-hacking? Further thoughts are appreciated.

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[-] mycabbages@mander.xyz 1 points 7 months ago

I think your interpretation is correct, no conclusion can be drawn from the results of this study.

If a similar study were repeated and adequately powered, I wouldn't consider it p-hacking. The larger sample should only decrease the uncertainty in the primary outcome. P-hacking would be like if they set out to measure like 20 different outcomes to see if some turn out to be statistically significant by pure chance.

As an aside, I think it might be hard to gather enough participants for an adequately powered study given how close the outcomes were in this study. I'm no cardiac surgeon, but I think mechanical heart valves are generally less favored compared with bioprosthetics. Furthermore, the addition of aspirin to warfarin may cut down the number of participants as well, as aspirin is not routinely recommended.

this post was submitted on 27 Nov 2024
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