I'm thinking about the chatter about #COVIDー19#EOL conversations. There's a risk here that we should say out loud. The moral satisfaction that can come to clinicians from encouraging a "good" death may mix the role of the Crisis Triage Officers (making fair and just
assessments for a community of how to share limited life support capacity) with the clinician (seeking care that is helpful and true to their specific patient as a person. For an individual patient, COVID is just ARDS. It is not the moral distress and even discomfiture (used
with its dictionary definition) that we experience about this awful pandemic. It is ARDS. So if walking the path of treatment for ARDS is true to them as a person, the bedside clinician should offer it unless and until a formal Triage team is forced to restrict such care.
It's too easy for bias to slip in and for mixed motives to draw our mind from our best selves. So from my perspective, the relevant framing is something like "COVID-19 has us all feeling nervous and even afraid. It's got us all thinking more about questions of life and death.
The lung problems COVID causes are like a condition we often treat in ICUs that we call ARDS. Many people recover, from ARDS after a long struggle on life support. Many do not recover. We may be at a crossroads here, where together we will need to decide which path to take.
For some the path will be to fight on, in hopes of recovery. For others, the path will be to focus on comfort and allow nature to take its course if we reach the point where your body would likely die without life support. As we think about these two paths that lead from where
we stand, which do you think feels most consistent with who you are as a person and where you are in the story of your life?" Nothing about ventilator shortages, nothing about how awful a pandemic is, just two people pondering together--however quickly and anxiously--
the big questions about the stories of our lives. If a patient chooses the path without life support, we work to honor them and provide for their comfort. Only those who would choose life support other things being equal would enter into any (we hope very unlikely)
problems of crisis triage. (I know that some situations may be too rapid to have this talk, but I have over the years been able to have this talk in many time-compressed circumstances.) I'm offering this not by way of criticism, but by way of what I hope is humanizing clarity.
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Just a couple thoughts from the realm of COVID-19 trials. 1. We are honestly very excited that fewer patients are afflicted by COVID-19. We will work as hard as we can to make sure trials are available to patients wherever they are in the world AND we will celebrate the fact that
this is becoming a rarer disease.
2. This really looks to be a disease of unvaccinated people now. It's striking how little ARDS we are seeing among vaccinated people. Not sure whether any specific line of evidence is helpful, but, wow. In the big COVID ARDS trial we're
running, about 90% of the patients are unvaccinated. There are the public health reasons to be vaccinated as well, but the clinical side of things -- preventing life-threatening disease -- is quite persuasive as well.
In case the story about full-dose anticoagulation in critically ill patients is confusing, a quick comment about the design and the reason what looks like harm is being called futility. Recall that in the prespecified Bayesian model, they used a threshold of 99% probability
that the OR was > 1 or < 1. This is an appropriate move. If you drop the probabilities lower, the Bayesian approach starts to look a lot more like an error-inflation machine. So if you're being rigorous, you want for 99% probability before you declare superiority or inferiority.
At the relevant interims, they met the 99% probability for superiority in the moderate (no organ failure) group, but they only had 98.5% probability of inferiority/harm in the organ failure/severe group. However, they had a futility bound that was clearly met, so they were able
I'm thinking more about the Pfizer vaccine (and grateful for those who have clarified some key points). First, I agree that early efficacy (right after the second injection) prevents infection in this patient population. That seems statistically certain.
Second, the population is those the investigator deems to be at high risk. I know that we've all wanted "wiggle room" in our inclusion criteria and that's not wrong. But for generalizability we want to know what "high risk" really means. In the event, it looks like "high-risk"
meant ~40/10,000 in the placebo group got COVID in the first month, versus ~4/10,000 (having to estimate because not enough detail in the news release). Note that (contra some bizarre innumeracy in Vox), this doesn't mean it fully protects 9 out of every 10 people who receive it
I've been hearing and thinking more about the Pfizer mRNA vaccine this morning. It does seem like this signal is likely to be real (there's not enough data in the news release to know, but most credible back calculations suggest that the efficacy signal is real). So I've been
trying to think what bothers me about it. And it's the ways that the culture of interim analyses seems to be shifting. Instead of the clear boundaries keeping the businesspeople from interfering with trials while they're being run, we're now seeing premature breaking of
that confidentiality for reasons that aren't entirely clear to me. I would hate for one of the legacies of the COVID pandemic to be that pharma gets to break the protections of interim analyses in order to beat their competitors in competition or sway the public. I can't wait
HAHPS trial also published--atsjournals.org/doi/abs/10.151…. I'm incredibly proud of @Research_Inter ability to run a pragmatic controlled trial in context of ORCHID to allow us to move more efficiently through candidate agents. There's an early suggestion that azithromycin may be
useful (looking forward to RECOVERY results in that regard). If anyone can remember back to March, there was a plan to provide HCQ with essentially no oversight, consent, or monitoring. With retrospect, HAHPS (and its sister trial HyAzOUT) were exactly the right response.
Based on the suggestion of a harm signal in trials and environments with minimal safety monitoring and open eligibility criteria and the entirely neutral effect seen in ORCHID, I believe that having HAHPS as a response to a public impulse to use unproven therapies outside of
Once a year I give a lecture to the 2d year medical students on humanizing intensive care. It's fun to be with these bright young people moving toward careers as physicians. One asked me an interesting and important question that seems like it's worth reflection.
Specifically, how do we engage people in positive and respectful ways if we don't have an authentic connection with the patient/family member? We know from RCTs that rote condolence letters after a death seem to raise and then disappoint expectations of intimacy, so how do we
support people without being ingenuine (and/or raising expectations we can't meet)? These questions resonate especially loudly in our modern cultural moment where authenticity is prized, and our radar is tuned to detect inauthenticity, especially among those with power.