The impact of evidence-based decision making in transfusion practice and potential impact on litigation

Transfusion practices throughout the world have developed mostly empirically since the late 1940s, with little or no published studies to validate them. In the past 20 years, possibly fuelled in part by increasing numbers of lawsuits related to transfusion medicine, there has been a concerted effort to improve the evidence base, such as through prospective, well-controlled randomized clinical trials (RCT) and by consensus conferences. These efforts have resulted in a number of peer-reviewed publications that are elucidating the scientific basis for use of red blood cells (RBC) and other blood components. The term 'evidence-based medicine' or 'EBM' was coined by Guyatt in 1991 [11, introduced widely in 1992 [2] and defined broadly in 1996 by Sackett et al. [3] as 'the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research' A more recent updated definition has recognized that the goal of providing EBM includes patient needs and is restated as the 'integration of best research evidence with clinical expertise and patient values' [4]. Since the recognition of this principle, the focus of every medical specialty, including transfusion medicine, has been to discern from the huge number of articles published each year, which are the 'best practices' that are supported by scientific data [5-8]. Despite the widespread endorsement of the concept of EBM and its incorporation into medical education [9,10], advocates and sceptics continue to express contrary positions regarding its value [11-16]. Resistance to 'cook-book' medicine persists. In the background of this drive towards EBM during the past 20 years, there have been relatively few instances in which the legal systems of various countries have experienced actual litigations related to transfusion harm, so the utility of EBM in cases related to transfusion practices has not yet been determined. However, the courts have had a chance to view EBM in other medical situations. The status of EBM in litigation in general will be discussed later in this article.