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One After 909's avatar

After 40 years in Critical Care, ID, HIV, COVID-19 and reading Malignant have created in me much cognitive dissonance about my profession and my practice.

I’m been through PA Catheters, DaO2 of 660 ml/min/m2, Intensive Insulin, Central lines, CVP, CVO2, and steroids for sepsis and XIGRIS (!!!). How ‘bout freeze-drying post Cardiac Arrest patients? Many were based on poor quality studies and magical thinking.

Since discovering Vinay I’ve begun to read articles more critically and inclined to question the next new thing.

SMART Physicians like Vinay will help navigate the way back to sanity.

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Steve Cheung's avatar

This is the same issue in cardiology. We want to see trials powered to show benefit in hard clinical endpoints; not in a bunch of surrogates markers, and/or soft outcomes absent proper blinding/sham control. We need regulators to demand this level of evidence before providing approval (for devices and meds) as this is the only incentive with teeth that will compel such studies to be done by sponsors/proponents.

As for proper “control arms”, I would concede a small bit to some of the researchers, in that “standard of care” might actually evolve during the course of study follow up (and about which investigators could not have foreseen or predicted). But equally obviously, control arm therapies should at least be “state of the art” at study onset.

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