“Randomised controlled trials (RCTs) are the de facto standard for answering clinical questions, delivering the highest grade of evidence available.” What sounds logical at first sight for many scientific problems is debatable for many other clinical situations: whereas RCTs are designed to answer one specific question in a given set of patients by falsification of a preselected hypothesis, they are quite weak in measuring efficacy of a bundle of therapeutic modalities that have been implemented in daily clinical practice. Since Patient blood management (PBM) is a multimodal, multidisciplinary approach, one might guess that efficacy of ‘PBM implementation’ is difficult to describe by an RCT, since thorough adherence to the protocol is quite difficult to achieve, resulting in endless discussion on the results.
As a consequence, the Western Australian approach presented by Leahy and coworkers seems quite attractive. Although retrospective description of PBM implementation over some years throughout a country has inherent methodological problems, the mere number of 600 000 participants makes the data presented very powerful. Noone can deduce from the data presented which PBM measure is the most important, but everyone has to admit that implementation to a certain degree of at least some of these measures consistuting PBM will result in a reduction of mortality and morbidity. The effects described are so impressive that it is difficult to imagine any confounding variable that should be mainly responsible for this improvement of outcome. This milestone paper could therefore help to convince some skeptical decision makers that are refusing PBM so far.
– Jens Meier