Thematic talk today about the ROLE of RCTs in Intensive Care Medicine. **TWEETORIAL** #ESICMphysio #FOAMed #FOAMcc
Randomised controlled trials (RCTs) are the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and are an integral component in the hierarchy of evidence which guide current clinical practice. #ESICMphysio ... but...
There are some problems... ncbi.nlm.nih.gov/pubmed/20413119 
Even outside medicine - there are questions raised about how useful they can be as well as their intrinsic bias: brookings.edu/blog/future-de… #ESICMphysio
2018: Do all RCTs produce biased results? tandfonline.com/doi/full/10.10… #ESICMphysio
2010: Should we be embracing other forms of measurements vs RCT? Randomized clinical trials have their place, but critics argue that researchers would get better results if they also embraced other methodologies. apa.org/monitor/2010/0…
So far these are fairly generic to medicine - nothing really specific to ICM. In 2010 - @jlvincen wrote about 'abandoning the RCT' in ICM. ncbi.nlm.nih.gov/pubmed/21164394 #ESICMphysio
Many RCTs in ICU pts have not demonstrated beneficial effects of the intervention under investigation, despite good preclinical and even previous RCT evidence. Many reasons incl. problems with timing, end point selection, and heterogeneous populations. #ESICMphysio
With this is mind, we should also look at the concept of statistical power and the RCT trial in ICM. ncbi.nlm.nih.gov/pmc/articles/P… #ESICMphysio
Look at TABLE 1 of this article showing the difficult landscape arising from the seminal RCTs and follow-up trials of given interventions --> Table here ncbi.nlm.nih.gov/pmc/articles/P… and paper here: ncbi.nlm.nih.gov/pmc/articles/P…
A criticism has been that unfortunately, these major RCTs have failed to deliver on the promise of answering questions/conundrums that arise in daily practice, leaving our field a landscape littered with negative and contradictory evidence... ncbi.nlm.nih.gov/pmc/articles/P… #ESICMphysio
Some blame the heterogeneity of the patient populations studied, clustered by poorly defined, syndromic conditions with wide variations of age, genetics, comorbidities, stage and severity of illness. The subsequent noise--> finding true research signals challenging #ESICMphysio
The difficult process leads to underpowered studies with conflicting results. There is incr used of novel, pragmatic clinical trial designs using predictive and prognostic
enrichment enrolment strategies are a rational choice to address this concern - like in cancer research!
enrichment enrolment strategies are a rational choice to address this concern - like in cancer research!
?Have RCTs examined the wrong outcomes altogether. Patients at the extremes of disease severity-->survive or die regardless of the intervention they receive. Mortality falls short of assessing meaningful, patient centred outcomes (i.e., quality of life, quality of death etc)
