Consent approach and patient notification in pragmatic comparative effectiveness trials in critical care

Advances in clinical informatics have facilitated the emergence of the learning healthcare system (LHS) model, which is defined by the National Academy of Medicine as one in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care. Pragmatic comparative effectiveness research plays a vital role in a LHS by rigorously evaluating two or more standard-of-care interventions under real-world conditions. Indeed, pragmatic clinical trials are increasingly utilized in critical care research and at least one large survey study suggests widespread acceptance by the general public. However, conducting such real-world research often requires rethinking traditional research regulations and ethics.

Dustin C Krutsinger, Katherine R Courtright