The study design was very simple - extremely sick people were given the drug on compassionate grounds (i.e. we don't know if it works but they might die anyway), and then their records were examined to see what happenedpic.twitter.com/ZRbmLhdKiY
Epidemiologist. Writer (Guardian, Observer etc). "Well known research trouble-maker". PhDing at @UoW Host of @senscipod Email gidmk.healthnerd@gmail.com he/him
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The study design was very simple - extremely sick people were given the drug on compassionate grounds (i.e. we don't know if it works but they might die anyway), and then their records were examined to see what happenedpic.twitter.com/ZRbmLhdKiY
Halfway through the methods, we get this wonderful gem
It seems the paper was ghostwritten by a Gilead employee (who is NOT an author)
That's an amazing thing to have published in a @NEJM paper!!!pic.twitter.com/e4NAiDaWnR
Don't get me wrong, it happens all the time, but rarely is it acknowledged so blatantly in the text
It also appears to go against @NEJM editorial guidelines which...isn't great?pic.twitter.com/yGnjNV9fXr
Statistical analysis appears reasonable, except for this gem Seems like they're basically saying "because the analysis method we chose couldn't easily accommodate best practice, we didn't do it"pic.twitter.com/oZCk7lD4TS
Given that this was a RETROSPECTIVE study, it seems likely that they could've just...used a different analysis methodology if they thought that multiple comparisons would be an issue? Weird
Anyway, on to the results, and this delightful first paragraph Titled "patient randomization" but doesn't talk about randomization (because there wasn't any) The perils of extra-short peer review perhaps?pic.twitter.com/2HffuB5Vw5
The paragraph also isn't good news for the study's rigor Of 61 total patients, 8 were excluded because of missing information Of the remaining 53, only 40 received the full course of the drug
Worth pointing out at this point that there's NO CONTROL GROUP That's a huge problem for inference - how do we know if any improvement seen in this trial had anything to do with the drug?
On to the patient demographics It's a relatively young, although fairly unhealthy population About what you'd expect given the inclusion criteria (although a bit younger perhaps)pic.twitter.com/TKCQ04GwFC
1) I love you. 2) Other thing I think about here is the duration of symptoms prior to initiation of therapy – wondering about the potential for survivorship bias for that uncontrolled mortality comparison to other mechanically-ventilated cohorts.
Yes I think that's definitely a concern - this is one of the many problems with the enrollment criteria. For example, people who were really sick may not have ever received the drug b/c they died before the compassionate use was approved
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