Closed Mind Body Intervention for Long COVID-19 [Massachusetts, USA]

[Evergreen]

I think you're saying specifically the word "bothered" changes it from being about symptom levels, to about how symptoms are perceived, which is more susceptible to bias unrelated to improvement. And that it'd be better to choose a more direct scale that is more like "are the symptoms present >3 days a week".

I think it opens it up to misinterpreting improvement in distress as improvement in long covid.

Now, since Donnino thinks long covid is distress, he wouldn't see that as a problem.

But I do, because I found CBT good for coping, but it did nothing for my ME/CFS.

I was thinking you were moreso criticizing including the more severely affected in the trial, but I can see how this scale could be measuring something which can change even if symptoms don't change.

Oh no! Not at all.

 

[Jonathan Edwards]

A subjective outcome measure being used as an entry criterion seems to bring in a new level of bias I had not thought of. Everyone will want to juice up the scoring at the beginning to get the recruitment going. And as Graham said in that video... Human nature innit.

 

[forestglip]

From https://www.shapiroinstitute.org/faculty-staff/mike-donnino,-md

Professor in Emergency Medicine, not who you‘d expect to research mind-body approaches?

He's interested in it because of his personal experience with it. From the Wired article:

Michael Donnino, a professor of medicine at Harvard Medical School, also attributes his recovery to Sarno. Around a decade ago, he began suffering from horrific back pain. “I had stopped working in the hospital,” he told me. “I was on partial disability.” Round-the-clock Tylenol, ibuprofen, and gabapentin did nothing. Neither did steroid injections or oral steroids. His back specialist said he had piriformis syndrome, and scans showed a potential problem with his sciatic nerve.

But then Donnino saw accounts of miraculous Sarno book cures online. “I got two chapters into the book and I thought, this is a bunch of baloney,” he said. “This is ridiculous. It is nothing like what I learned in medical school.” After abandoning the book, something told him to give it one more chance. So he did. “Within 24 hours I was feeling tremendously better.” In less than a week he was back at work. In four months he was pain-free.

Donnino was inspired to design and run a pilot randomized controlled back pain trial that used Sarno’s approach (funded by the CEO of Quora, another Sarno convert). [...]

 

[Robert 1973]

You have to hand it to them. They may not have resolved the issue of the uninterpretabability of unblinded trials which rely on subjective outcomes measures but they’ve found a way to introduce even more bias!

Now I’m wondering if the mysterious active comparator arm may be teaching the patients students to be more bothered about their symptoms.

 

[Robert 1973]

From the Wired article (my bold):

But then Donnino saw accounts of miraculous Sarno book cures online. “I got two chapters into the book and I thought, this is a bunch of baloney,” he said. “This is ridiculous. It is nothing like what I learned in medical school.” After abandoning the book, something told him to give it one more chance. So he did. “Within 24 hours I was feeling tremendously better.” In less than a week he was back at work. In four months he was pain-free.

Donnino was inspired to design and run a pilot randomized controlled back pain trial that used Sarno’s approach

Funny that he chooses to mention that he was back at work in less than a week as evidence of the efficacy of the intervention, and yet he chose not to use returning to work as an outcome measure in his trial (or any other objective outcome measures). I don’t suppose he was taught to do that at medical school either – unless he was schooled in BPS methodology.

 

[rvallee]

You have to hand it to them. They may not have resolved the issue of the uninterpretabability of unblinded trials which rely on subjective outcomes measures but they’ve found a way to introduce even more bias!

Now I’m wondering if the mysterious active comparator arm may be teaching the patients students to be more bothered about their symptoms.

This is pretty much it, isn't it? The discipline solved the bias problem by making bias a good thing, necessary even. So now they may still have a highly suspicious 90% or so success rate, which is obviously impossible, but by increasing the bias and setting the baseline as 90% success rate being the floor, mainly by defining success as whatever, then more bias means better so of course you want more bias. And they'll still claim equipoise because bias in favor of good outcomes is equipoise. If you aren't biased, you're doing it wrong,

What an incredibly odd thing. Truly one of the most bizarre eras in human history.