Our new paper in @EJCI_News argues that Randomized trials are necessary in medicine & PH for interventions w putative benefit & at best MED to LG effect size.
Parachutes & smoking are not good counter examples
Some people argue that b/c we did not need RCTs to know smoking is harmful or Parachutes are life saving, we don't need them to test cloth masking, or the Impella, or some new cancer drug, or HCQ, or <insert ur favorite practice>
But this is based on misunderstanding
There is a huge range of things we can do to someone that might hurt them or save them, imagine the spectrum (below)
Let's start on the harms side
At most extreme, you could shoot someone in the chest at point blank range or throw them off a cliff
There has never been an RCT that doing that is harmful.
Wow, who knew?!?
But we know it is harmful. The effect size is massive. Near certain death.
Now, look at the right most edge
There is no RCT that pulling someone out of the way of a speeding truck is life saving, & no (non-humorous) RCT of parachutes but again the effect size is massive.
Visible to naked eye
Now look to the middle left.
Smoking, pollutants in the water, carcinogens in food-- none of these have RCTs showing they are harmful, and we generally do no not run RCTs for putative harms
We draw upon risk factor epi & make a determination that mitigation is reasonable.
If we wish, we can subject smoking CESSATION strategies to an RCT. You can power trials for smoking reduction, but there is no rule that says you can't power them for all cause mortality
By doing that, you immediate move to the right side of the mid-point; the green arrow
you have an intervention that possibly offers a modest to marginal effect size.
Turns out that is where most of biomedicine lies
Or what we call "The RCT Zone"
Here, RCTs are desperately needed to separate true effect from hope & wishful thinking & propaganda
Early in the pandemic, some opposed cloth mask RCTs saying that cloth masks were like a parachute
Seemed farfetched to me, and now
That was a terrible decision
Of course their effect on the primary endpoint in Bangladesh was 0%. Cloth failed. Surgical had 11% RRR (but open Qs)
Regardless, RCTs were not only possible, they were desperately needed; the effect size was at best modest but possibly null, and RCTs work well to separate
True effects from wishful thinking
If we had more RCTs of masking-- particularly kids in school--- we would end a bitter debate that is driven by low credibility data
There's not a single randomized controlled trial that shows people who undergo a coronary artery calcium test live longer than those who do not undergo it. Everyone will benefit from increasing exercise and eating better and the score is irrelevant
Maybe the only cancer screening test that has any utility under 35 is the pap smear. Mammography doesn't improve survival at any age, and has no data in this age group. Totally crazy recommendation
Glad that we @vkprasadlab have published over 20++ peer reviewed papers on COVID19 policy to date & many more to come
I will share them here & a free link to all of them at end
We see policy failure
#1 visitor restriction
It was sad to separate family from dying people, & had no data
Cloth masking 2 year olds was an unforced error by @cdcgov and @AmerAcadPeds, who pushed this policy with no credible data, and despite its obvious silliness
Long COVID is an evidence based disaster
There is a strong narrative that is not well supported by the evidence.
To date, besides anosmia, there is no evidence COVID has any more long symptoms than being equally ill with any other respiratory virus. period.
A new 22 page essay by Mariana Barosa, @ID_ethics and me!
"We argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies"
🧵 link.springer.com/article/10.100…
Our essay reimagines the status quo. Instead of implementing and deimplementing and never knowing the answer, Public health must work to reduce uncertainty.
Shown nicely in Figure 2
We discuss many Non pharmacologic interventions tried and their limited evidence
This table represents an evidence based disaster. Nearly none of these were tested with proper trials
Forget beach closures and taking the swings out of parks
When I read an #ASH23 abstract that asks whether PFS or MRD is a surrogate endpoint in FL (L) or CLL (R), I know instantly the person on the left did it right and the person on the right messed up
Small cell lung cancer is a horrible diagnosis, and I feel sadness for anyone who has it
A double lung transplant for small cell lung cancer is complete nonsense. @VUMChealth is just making things up. This story is so sad bc doctors want to practice on the island of Dr Moreau
Just OUT! By @DavidBenjaminMD
We discuss evidence for STARTING & STOPPING cancer drugs!
What do I mean?
Currently in cancer med, we ~always start treatment at first sign of metastatic disease, and stop at progression, but....
🧵 (follow)
free link authors.elsevier.com/a/1i2MQ7tJEDS6…
... does this make sense?
The table shows trials testing early starting vs. delayed starting of systemic Rx.
For many diseases, there is no advantage to treating even widespread, asymptomatic disease
For most disease, however, there is no study at all!!
We truly don't know
But generally we assume. In many tumor types, we treat even asx or mildly symptomatic metastatic diseases (denovo or recurrent)
Now, lets consider the flip side of the coin. When should we stop treatment....