24/n I should specify that none of this makes the study totally sketchy, it's just all really weird and they are things that the authors should have explained in the paper
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25/n Overall, what we have is a study that, if run as specified, was a non-randomized prospective cohort study that gives us very little/no new information on vitamin D for COVID-19
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Replying to @GidMK
I've looked a bit into this. In Spain, every RCT must be registered at REEC https://reec.aemps.es/reec/public/web.html … REEC is the national RCT portal In fact, every approval goes through it, allowing communication between the Spanish/European Drug Agencies, the local Commitee & the researchers
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It is more than a registry; it is the portal where all RCTs are processed, so there's no chance that an approved RCT didn't pass through REEC. Looking for vitamin D RCTs, there's only one ongoing Vit D trial: its identifier is 2020-002312-43 https://reec.aemps.es/reec/estudio/2020-002312-43 …
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The registered RCT is led by a researcher from the Severo Ochoa hospital; the Hospital del Mar doesn't participate as a recruiting centre Either the published preprint doesn't correspond to an RCT or this is a case of a severe ethical transgression; most probably the former
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The remaining approved Vitamin D RCTs are stopped, as far as I have found
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I think the best thing that can be done with this preprint is to reanalyse it as a quasiexperimental study, seeking expert help by an Epidemiologist
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aure Retweeted Nick Brown
We will wait for the Committee's response but, if nothing is found in REEC there's no chance this is an RCThttps://twitter.com/sTeamTraen/status/1361002525839736832?s=19 …
aure added,
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Brief Update, There's an ongoing trial led by Cordoba in which the Hospital del Mar participates (not leads) https://reec.aemps.es/reec/estudio/2020-001717-20 … But the dates of approval don't match the ones declared in the preprint: No RCT was ongoing during the dates written in the preprint
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First patient recruited in the Cordoba RCT: 5-06-2020 The preprint study was conducted in Barcelona (single centre) between March 1st & May 31st 2020 It seems like observational data collected before a trial, thus the lack of randomisation evidence & methods issues still applypic.twitter.com/O8DJ09wf4U
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I'm beginning to suspect, based on the author reply and the timeline, that this is actually a retrospective review of medical records
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Maybe it's just me. But also, "standard therapy" seems to be poorly-defined, potentially quite heterogenous, dependent on patient progression +/- ICU +/- clinical judgement, especially wrt to dex: mentioned in text w/out further reference in analysis. Was it accounted for?pic.twitter.com/bybvLXx1gq
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aure Retweeted
Now, that's wonderful news!! https://twitter.com/schneiderleonid/status/1362691728789147649?s=19 …
aure added,
This Tweet is unavailable.0 replies 0 retweets 2 likes
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