Briefly, this means that any claim about the (lack of) efficacy of the treatment based on this study is misleading and unfounded (reminder: the absence of evidence of efficacy is not the same as the evidence of an absence of efficacy)
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Third problem: this is a *really* small sample of patients (n=11). Statistically speaking, it increases the risk of "false negative", namely the probability that we fail to see an association that truly exists.
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Of course, taking about type 2 error in a single-arm study is a bit out of scope. But statistical uncertainty does play a role. What if instead of including 11 patients the authors had included 100 or even 1000 patients? What if we could magically replicate this study x10,000?
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If we did such a simulation, assuming that the 11 patients from this study are a random sample of severe Covid-19 patients, the 2/10 viral clearance rate observed by Molina et al. would actually sit anywhere between 12.8 and 29.7 in half of the studies (50% confidence interval).
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That’s pretty wide, and it tells you that the sample size simply creates too much statistical uncertainty to make precise inferences. However, it also tells you that there is also very little chance that the viral clearance rate could be 70% in this setting.
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Ok, so what? Should we trust this paper? The article should be considered as a case series report, nothing more. The sample size, the mono-centre and single-arm design, and the lack of detailed data in the paper (e.g. no table, no day-by-day PCR results) are major limitations.
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That being said, the description of these 11 cases paints a pretty bleak picture. Within only 5 days, 1 patient died, 2 were transferred to the ICU, and 1 had to discontinue hydroxychloroquine because of side effects.
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At the very least, this proves that the combination of hydroxychloroquine and azithromycin is not the “miracle cure” that the media and some scientists have depicted.
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And for once, the authors have a reasonable concluding sentence: “Ongoing randomized clinical trials with hydroxychloroquine should provide a definitive answer regarding the alleged efficacy of this combination and will assess its safety”.
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Did I miss anything important
@statsepi@tmorris_mrc@jd_wilko@DgCostagliola@profnpicard (and others) ?18 antwoorden 5 retweets 32 vind-ik-leuksDeze collectie tonen
qPCR for viral count. Viral shedding from other sites, not simply a deep NP swab. It has simply shown that viral RNA has been detected, at unknown concentration, in infected patients. That's it.
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