seacoaster wrote: ↑Mon May 11, 2020 5:54 pm
“Main Outcomes and Measures Primary outcome was in-hospital mortality. Secondary outcomes were cardiac arrest and abnormal electrocardiogram findings (arrhythmia or QT prolongation).”
??? What am I missing?
those are what they are looking for. what they are trying to measure. here is the conclusions and relevance from the abstract:
Among patients hospitalized in metropolitan New York with COVID-19, treatment with hydroxychloroquine, azithromycin, or both, compared with neither treatment,
was not significantly associated with differences in in-hospital mortality. However, the interpretation of these findings may be limited by the observational design.
the conclusion after description of the study is the same verbatim.
here is the relevant info under primary outcomes:
In the primary analysis, following adjustment for demographics, specific hospital, preexisting conditions, and illness severity,
no significant differences in mortality were found between patients receiving hydroxychloroquine + azithromycin (adjusted HR, 1.35 [95% CI, 0.76-2.40]), hydroxychloroquine alone (adjusted HR, 1.08 [95% CI, 0.63-1.85]), or azithromycin alone (adjusted HR, 0.56 [95% CI, 0.26-1.21]), compared with neither drug (Table 3) (complete case analysis variable completeness was 86%).
and secondary outcomes:
Across all groups, the most commonly reported adverse event was abnormal ECG findings, particularly arrhythmia (Table 4). Abnormal ECG findings were more common among patients receiving hydroxychloroquine + azithromycin and hydroxychloroquine alone, both overall and among those with a record of ECG screening.
However, in logistic regression models of abnormal ECG findings, there were no significant differences between the groups receiving neither drug and each of the hydroxychloroquine + azithromycin and hydroxychloroquine alone groups.
and for cardiac arrest:
A greater proportion of patients receiving hydroxychloroquine + azithromycin experienced cardiac arrest (15.5%) and abnormal ECG findings (27.1%), as did those in the hydroxychloroquine alone group (13.7% and 27.3, respectively), compared with azithromycin alone (6.2% and 16.1%, respectively) and neither drug (6.8% and 14.0%, respectively).
In adjusted models with those receiving neither drug as comparison, cardiac arrest was more likely in patients receiving hydroxychloroquine + azithromycin (adjusted OR, 2.13 [95% CI, 1.12-4.05]; E-value = 1.31),
but not hydroxychloroquine alone (adjusted OR, 1.91 [95% CI, 0.96-3.81]) and azithromycin alone (adjusted OR, 0.64 [95% CI, 0.27-1.56]), and also in patients taking hydroxychloroquine alone vs azithromycin alone (adjusted OR, 2.97 [95% CI, 1.56-5.64]; E-value = 1.81).
under limitations:
Limitations
This study has several limitations. First, in sampling first hospitalizations, possible readmissions to other facilities may not be captured. Second, mortality was limited to in-hospital death, and patients discharged were assumed to still be alive during the study period. Third, some potential confounders such as inflammatory markers associated with severity of COVID-19 in prior studies were not frequently measured and thus not available for modeling.18 Fourth, the rapidity with which patients entered the ICU and underwent mechanical ventilation, often concurrently with initiating hydroxychloroquine and azithromycin, rendered these outcomes unsuitable for efficacy analyses. Fifth, adverse events were collected as having occurred at any point during hospitalization, potentially before drug initiation, although both medications were started on average within 1 day of admission; future studies should examine the onset of these events relative to drug timing. Sixth, it is likely that there is unmeasured residual confounding due to factors not included in the analysis.
For the significant associations of hydroxychloroquine + azithromycin vs no drug with cardiac arrest and hydroxychloroquine alone vs azithromycin alone with cardiac arrest, the respective E-values for the lower bound of the OR’s CI of 1.31 and 1.81 suggest factors moderately associated with treatment and cardiac arrest could render these associations nonsignificant.22 Seventh, for the subsample of 211 patients receiving azithromycin alone, the HR point estimate for mortality was 0.56, but the confidence interval crossed 1.0. This suggests the possibility of a true protective association, but it may also represent unmeasured confounding; it may warrant additional study. Eighth, the confidence intervals for some of the findings are wide, reflecting limits in study power for some analyses.
Clinical trials remain needed to provide definitive causal evidence of the effect of hydroxychloroquine and azithromycin on mortality, while also providing an opportunity to more finely control baseline patient severity and the dose and timing of drug administration. Nonetheless, the findings of the present study should be considered in concert with recent COVID-19 treatment guidelines from the National Institutes of Health and Infectious Diseases Society of America as well as the statement regarding safety concerning use of hydroxychloroquine from the US Food and Drug Administration.30-32
the one bad association they had found was potentially cardiac arrest (but not arrhythmia) with the combo together versus neither. then under limitations, the bolded describes that it very well could be nonsignificant.
i'll leave it to experts as to whether the rest of the limitations are abnormally long, but also bolded above under limitations would seem to be what are going to be needed to determine whether hcq is effective against the virus. and actual clinical trials, not post-observational studies.
this one concluded that there wasn't a significant change in mortality, its primary objective, for the groups it measured. those groups were wildly different in their application (with those receiving drugs supposedly in much worse shape to start out with). if we assume all the calculations they have to make to adjust those findings to make them parallel enough to compare are accurate, hcq has been advocated by most experts that i've seen as potentially being valuable very early on. not in advanced stages, after hospital admissions, etc. whether that turns out to be the case, we'll see. what the study doesn't say is that it is worthless.
what we will see, and need to see to have any real idea, at some point is actual clinical trials, and some random double blind ones. used at various stages, i'm sure. there may be over 150 of them going on right now involving hcq or chloroquine.