Multicentre RCTs evaluating mortality in ICU – Doomed to fail?

Multicentre RCTs evaluating mortality in Intensive Care : Doomed to Fail ? Gustavo A. et al. Crit Care Med, 2008, vol 34, no 4.

The authors performed a systematic search for multicentre RCTs in adult ICU targetting mortality as a primary outcome measure. Perhaps surprisingly they found only 72. Of these, 10 reported a positive effect, 7 negative and 55 neutral.

The authors make some interesting points…

• of the 10 positive results not all have been implemented, either because of tight inclusion criteria or subsequent neutral/ negative evidence
• 30% of studies failed to adequately report a power calculation
• assuming a commonly targeted mortality benefit (10%), they estimate approx 60% of studies would be underpowered at the 90% confidence limit.

So is mortality as unrealistic endpoint in disease states inadequately differentiated (like ARDS or sepsis) ?