Improved survival in critically ill patients: are large RCTs more useful than personalized medicine? No

Excerpt

Randomized controlled trials (RCTs) are considered the best evidence on which to base change in practice. We all agree that only RCTs can account for unmeasurable factors that may influence the response to a therapeutic intervention. Yet, so many large RCTs have been negative in critically ill patients. Whatever we test does not seem to make a difference to outcomes: the pulmonary artery catheter [1, 2], intracranial pressure monitoring [3], optimal blood pressure levels in septic shock [4], central venous oxygen saturation monitoring [5], blood transfusions, and so the list goes on. We were so proud to have finally developed a drug for sepsis, drotrecogin alfa (activated) [6], but this was such an unexpected and surprising event that another study was performed, which negated the results [7] and the drug was taken off the market. Admittedly, some RCTs have identified interventions that caused harm, and this is of course very important: the best example is the large study of tidal volume in patients with acute respiratory distress syndrome (ARDS) [8]. But, are there any studies that have shown improved outcomes in critically ill patients? In fact, the very few that showed a survival benefit concerned interventions that prevented harm rather than providing benefit: for example, the use of muscle relaxants [9] and prone positioning [10] probably provide benefit in ARDS by limiting barotrauma. …