Clinicians increased awareness of RCT structure

[llynn]

https://x.com/PulmCrit/status/2083172664173031665?s=20

Note the clinicians are increasingly aware of the structural flaws of fake measurements as RCT entry criteria and outcomes. This is a causal integrity RCT (a CIR) but with a guessed standard composite outcome. Clinicians are now enlightened and have learned to look beyound internal validity. Pathological RCT design no longer passes the increased awareness of clinicians of RCT structural flaws.

We are witnessing a progressive decline in deference to the expertise in RCT design once given, with great trust, to Trialists and statisticians. This will only get worse until RCT causal structure becomes a central consideration of RCT design.

I warned about this 6 years ago. Time to listen.

What is a fake measurement tool and how are they used in RCT

I have linked an article below published this month. This provides more evidence that the measurement tools used for critical care RCT esp. for sepsis and mortality are often fake. Those who have studied this issue did not need more evidence but perhaps if enough of these studies are published the perceived bright star of SOFA will fade (as SIRS has faded). This study is no surprise given there has not been a single reproducibly positive sepsis RCT for 30 yrs. Now fake is a harsh word and I d…

[llynn]

If you review my past posts you will see that all of my predictions have come true. Here are the flawed RCT causal structures (gates).

SIRS Abandoned after 24 years of failure and harm

AHI. Now generally recognized as not associated with morbidity

Berlin ARDS Abandoned after contributing to ventilation guideline failure during COVID

Sepsis 3 Used since 2016. All Failed

CAP Criteria Subject to many polarity reversals. Failed in latest Bayesian ReMAP CAP platform trial.

AKI (Acute Kidney Injury) About to be modified to correct 14 yr (childish) mathematical flaw.

This is decades of wasted RCT and harmful guidelines.
Did I recognize this when no one else did or was I the only one willing to call them out? Well we know the answer to that but just in case, here is an example of how I find a childlike standardized measurement mistakes. Let’s look at AKI urine output threshold for Kidney injury in the linked JAMA article.

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If one literally applies the KDIGO definition using actual body weight, (which they apparent did) of 0.5 cc/kg/hr.

70 kg → Kidney Injury threshold 35 mL/hr
90 kg → 45 mL/hr
120 kg → 60 mL/hr

The threshold continues to increase with body weight because there is no upper limit specified.

For a 6-foot, BMI 27 man (the average BMI in the study):

45 mL/hour is the Stage 2 AKI threshold.

This means that producing a mean of 44 mL/hour for 12 hours would satisfy the Stage 2 AKI even though the absolute urine volume is roughly 540 mL over 12 hours! (Almost “race horse” level.)

Looking at the appendix in the linked trial it appears they used actual body weight. I could have missed it Can anyone find this? Weights and UO are not graphed. Really it hardly matters since KDIGO does not specify. The new 2026 KDIGO “draft” addressed this but nephrologists have allowed this foolishness for 14 years and this study probably used the present standard KDIGO which is….absolutely inflationary and fake.

“Synthetic syndromes”. guessed composites and fake clinical trial science and pathological RCT design are normal in critical care RCT design. All of this could be prevented by explication of the RCT causal structure and gates. But then again.. everyone already knows that.

https://t.co/1Ig6meN4Ac

Like AKI and the others above, here is the timeline of the pathological RCT causal design structure for sepsis.

Sepsis 3 (1996 SOFA) is the present pathological but standard RCT gate.