8/n More likely, in my opinion, is that this is simply as the authors describe an observational cohort study of people in hospital who were either given calcifediol or not. They just use the word randomize incorrectly
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9/n But even then, there are massive issues For example, the PRIMARY ANALYSIS (60% mortality reduction) excludes ~20% of their total sample because of missing baseline data on vitamin D statuspic.twitter.com/jPDvuCHBrZ
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10/n And we get no information whatsoever on these missing people. Were they from the treated group? The control? Did they die, go to ICU etc? We have no idea!
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11/n Another issue is that there were 8 presumably quite different COVID-19 wards, but the authors basically ignore these differences. There is no discussion of the purpose of the wards, and no correction for it in the statistical model
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12/n Could the results be explained by different wards having different admissions protocols? Potentially, but we are given no information to make this assessment at all
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13/n This is even more troubling when you consider that the baseline vitamin D levels are different in the treated and control patients (for whom there was vit D information) So we know that the wards were different, but we don't know how much or whypic.twitter.com/Zr4TFceOOE
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Health Nerd Retweeted Neil O'Leary
14/n There's more. If this WAS indeed a cluster RCT (I'm skeptical), then the authors did the wrong analysis and the results are probably actually non-significant Excellent thread here:https://twitter.com/lycraolaoghaire/status/1360765704849481731?s=20 …
Health Nerd added,
Neil O'Leary @lycraolaoghaireA cluster-randomised trial with 5 wards in the treatment arm and 3 wards in the control arm. Only it's not described as such. Did they control for the correlation of outcomes within ward? https://twitter.com/DavidDavisMP/status/1360647462197878791 … pic.twitter.com/cHYBI9j4zcShow this thread2 replies 10 retweets 111 likesShow this thread -
Health Nerd Retweeted F. Perry Wilson, MD MSCE
15/n There are also numerous issues I haven't covered that
@fperrywilson does a great job dissecting here:https://twitter.com/fperrywilson/status/1360944814271979523?s=20 …Health Nerd added,
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16/n There are other odd inconsistencies with the study. For example, they had 93 patients die and 110 ICU admissions That's a startlingly high ICU mortality rate, unless a majority of patients who died were not admitted to ICU
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Replying to @GidMK
This is correct. A majority of patients who die are not admitted to ICU. In the UK at least you need to be relatively young and fit to make the cut. Most Covid fatalities are palliated.
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But this is a pretty healthy severe population - average age in the low 60s, modest comorbidities. The authors should really explain who went to ICU, who died, and their characteristics
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