Perspectives on Evidence-based Medicine

Interesting perspective on evidence-based medicine and the current drug development regulations.

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Is it a bridge too far?

¨Over the past 20 years or more, the concept of evidence-based medicine (EBM) has increasingly been accepted as the gold standard for decision making in medical/health practice and policy.

EBM provides a standard procedure for using evidence in clinical decision making. It is framed as “…the conscientious, explicit and judicious use of best evidence in making decisions about the care of individual [sic] patients. The practice of evidence-based medicine means integrating individual clinical experience with the best available external clinical evidence from systematic research” [1]. Muir Gray regarded this definition as too doctor-centric and expanded it to emphasize the importance of the patient perspective and proposed that, “…evidence based clinical practice is an approach to decision making in which the clinician uses the best scientific evidence available, in consultation with the patient, to decide upon the option which suits the patient best.” [2]. In their respective papers, both Sacket and Gray described the stages of EBM decision making as (1) assessment and synthesis of external evidence using clinical epidemiology, systematic search and meta-analysis, and other techniques such as cost analysis and modelling; (2) use of probabilistic reasoning, taking into account, clinical expertise, and patients’ values and preferences. Remarkably, this broad but sensitive approach to rational clinical decision making was actually followed when applied to guideline development, but reduced the evidence in a skewed manner. Only evidence from explanatory randomized controlled trials (RCTs) was admitted as ‘reliable evidence’.

Whilst the value of EBM has been staunchly defended by its proponents, it has been widely criticized by many disciplines including clinical practice [38], epistemology [914], health sociology [15, 16], and implementation science [17]. Moreover, in recent years, previously supportive EBM researchers argue for a ‘renaissance’ of the movement that follows and applies their original broad principles and multidisciplinary values, specially regarding the components of EBM related to shared decisions with patients and to expert judgment, built of evidence and experience [18, 19]. The main argument is that, in spite of its benefits, EBM could have also had important negative consequences for healthcare delivery, policy and financing. Examples of this include (1) failing to manage complexity, the individual’s needs, and the person’s context and issues such as multi-morbidity; (2) the quantity of research studies and the variable quality, which has become impossible to manage and in some cases lack clinical significance; and (3) the medicalization of life, namely creating new diseases for non-specific complaints and the use of the evidence-based ‘quality markers’ to widely promote drugs and medical devices [2022].

This paper contributes to the descriptive rational reconstruction of EBM by analysing its historical development and controversies [23], as well as its limitations in the current healthcare context. We approach this analysis from a complex adaptive systems science perspective with its focus on the relational interactions of health and healthcare variables [24] and the unified approach to the philosophy of science as suggested by Schurz [23]. A complex adaptive view of health as a balanced state between the person’s physical, social, emotional and cognitive experiences and its consequences for shaping complex adaptive healthcare and healthcare systems as highly responsive to the person’s unique needs as well as a complex adaptive understanding of medical knowledge have been described in detail elsewhere [2527]. The unified approach to the philosophy of science provides a systematization of the basic assumptions of scientific knowledge and revises the role of values in science. It provides a new framework for understanding the differences between the phases of discovery, corroboration and implementation in science. Its importance for defining new areas of scientific knowledge and the role of different logic inferences in each phase have been reviewed elsewhere [28].

The present paper is structured in four sections: in the first, we review the origins, principles and actors who contributed to the rise of EBM, whilst in the second, we discuss why this movement evolved so rapidly and was so broadly accepted. The third describes a ‘restricted’ approach to EBM and its use in designing standard methods for developing practice guidelines, and finally, we comment upon the current challenges faced by the EBM movement in the context of systems thinking and implementation sciences.¨


Go to the profile of Elisabeta Comsa

Elisabeta Comsa

PharmD, MSc, PhD, CNRS - Centre national de la recherche scientifique

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