Main results (outcomes part 1): Body temperature recovery time: (a) Treatment group: 2.2 (SD 0.4) days (b) Control group: 3.2 (SD 1.3) days /9
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Main results (outcomes part 2): (a) Treatment group: 2 patients worsened (incl. 0 to severe), 19 stable, 25 improved. (b) Control group: 9 patients worsened (incl. 4 to severe), 5 stable, 17 improved. /10pic.twitter.com/WA3rXHO2qs
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The authors conclude that in spite of the small sample size, their study "partially confirms" the efficacy of hydroxychloroquine in the treatment of COVID-19. They add that, in the absence of a better alternative, it is a "promising practice" to use hydroxychloroquine. /11pic.twitter.com/C3paIZYy0S
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Convinced? I'm not, and here is why.
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Clear deviation from the protocol: The trial protocol on ChiCTR mentioned 3 groups, with 100 patients in each: (1) HCQ 400mg/d, (2) HCQ 200mg/d, and (3) a placebo. Where the heck is group 2, and why has placebo been replaced by standard care? http://www.chictr.org.cn/showprojen.aspx?proj=48880 … /13pic.twitter.com/W30VBBKubP
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Underpowered study: This trial was supposed to recruit 300 patients (200 receiving HCQ and 100 receiving placebo). Yet, the analysis reported in the preprint only includes 31 patients in the HCQ arm and 31 in the standard care arm. Of course, no explanation whatsoever... /14
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How big should it be? Assuming no loss to follow-up (which seems to be the case here), 5% type-1 error rate, 85% power and Fleiss CC, a total of 128 COVID-19 patients (64+64) would be required to demonstrate the 55% vs. 81% proportion of patients who "improved" in Table 2. /15
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Lucas Morin Retweeted Darren Dahly, PhD
A multitude of underpowered studies will not be of any use if we want to seriously answer the question "Is hydroxychloroquine beneficial for patients with COVID-19?".
https://twitter.com/statsepi/status/1234576310703398912?s=20 …
/16Lucas Morin added,
Darren Dahly, PhD @statsepiYou enter a pitch black room to look for a small, specific object. You have a flashlight. As soon as you enter, the batteries die and the once bright light fades. You struggle in the dark to find the object, but eventually give up. Was the object there or not?Show this thread4 replies 18 retweets 91 likesShow this thread -
Randomization process is questionable: (1) Randomization was "stratified by site" (page 4): I was under the impression that there was only one site... (2) With only N=62, the number of patients randomized to the treatment arm is exactly 31. A happy coincidence, I guess? /17
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Replying to @lucasmorin_eolc
Also, there was no placebo used in the control group. (If there was, I couldn't find mention of it.) Thus, the study cannot truly be said to be "double blind," because patients would know if they were getting the drug or not, as would nurses, and, possibly, treating physicians.
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Given that several of the outcomes (cough severity, for instance) are patient-reported and have a large subjective component, placebo effects could be the explanation for the effect seen on the outcomes that have a significant subjective component.
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Replying to @gorskon
Lucas Morin Retweeted Lucas Morin
Completely agree. I added this "side note", but I guess it got lost in the thread...
https://twitter.com/lucasmorin_eolc/status/1245091433062830081?s=20 …Lucas Morin added,
Lucas Morin @lucasmorin_eolcSide note n°4 While the pre-registered protocol mentions a placebo (starch pill 2x day), this is nowhere to be found in the paper. Yet, in the absence of placebo, the authors' claim that "neither the researcher nor the patients were aware of treatment assignment" is dubious.Show this thread0 replies 0 retweets 1 likeThanks. Twitter will use this to make your timeline better. UndoUndo
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