Ibrutinib resistance in chronic lymphocytic leukemia.

n engl j med 370;24 nejm.org june 12, 2014 2352 portant questions both about the nature of the evidence and about its sufficiency, a topic that has been the subject of inquiry and discussion in the patient-safety community for well over a decade.1 As noted in the editorial, replications have confirmed substantial effects regarding the use of a surgical checklist, but rigorous randomized trials have not been carried out and are unlikely to be. In contrast to the relatively simple act of providing a new drug or procedure, implementing the surgical checklist calls for performance of a diverse array of 20 or more actions, which can, and should, vary from one institution to another. An even more important barrier to performing a randomized trial is that implementation of the checklist almost always requires major culture change. Although culture can (and should) be measured, because of its unique nature in a given operating suite (even among individual rooms), the more relevant comparison after implementation of a checklist is with the prior condition, a before-versus-after study, not with other organizations with very different cultures. The key culture change facilitated by the surgical checklist is the development of highly functioning teams, the value of which is well supported by evidence from many venues in and out of health care. Weiser and Krummel reemphasize the key learnings from all checklist replication studies: success requires great effort directed toward the implementation process and strong leadership, a point also made by Haynes et al., who in addition note that the 9% reduction in mortality that Urbach et al. report could be a significant trend if mortality was followed for a longer time period. Robblee notes a potential benefit from implementing the surgical checklist that has been underappreciated in the literature: the identification of near misses, which are defined as errors or malfunctions that might well have caused harm if they had not been intercepted. If these events are analyzed, the underlying process failures (socalled latent failures) can often be identified and the process redesigned to prevent the errors from recurring. Indeed, if and when performance of the surgical checklist is fully institutionalized as an integral part of a culture of everyday teamwork in the operating room, it may turn out that one of its major benefits will be identifying opportunities for process improvement. Lucian L. Leape, M.D.