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Randomized trial reveals higher overall mortality in ICU patients receiving intensive medical nutrition therapy, suggesting significant selection bias.
Objective: To test whether selection bias has affected the reported effect estimate for IMNT in comparison to SNSC (RD –0.24. 95%CI: -0.43 to -0.05), concerning overall mortality in ICU patients. Method: Trial adjusted, simulated comparator trial (SCT) based I2 test for single randomised controlled trials, using revised I2 threshold limits. Result: A baseline covariate imbalance, either due to chance or due to selection bias was established, being equivalent to selection bias level = B% 50-60 (Bias category = 3). This level suggests that 41-60% of (32 – 47 of the total 78) subjects were non-randomly allocated in favour of one treatment group above the other.. Conclusion: The effect estimate reported by the tested trial suggests a significantly higher overall mortality in the IMNT intervention group. The selection bias level, estimated by use of the trial adjusted, simulated comparator trial (SCT) based I2 test for single RCTs, B% = 50-60%, appears to be high enough in order to have affected the reported estimate. In line with new findings, this report updates previous report to the same RCT: EBSM Volume 2, Issue 2, 2026 Pages 35-38, DOI: 10.5281/zenodo.18456995.
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Steffen Mickenautsch (2026) studied this question.
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