Evidence-based medicine: is it a bridge too far?

Fernandez et al. Health Research Policy and Systems (2015) 13:66 DOI 10.1186/s12961-015-0057-0 REVIEW Open Access Evidence-based medicine: is it a bridge too far? Ana Fernandez1*, Joachim Sturmberg2, Sue Lukersmith3, Rosamond Madden3, Ghazal Torkfar4, Ruth Colagiuri4 and Luis Salvador-Carulla5 Abstract Aims: This paper aims to describe the contextual factors that gave rise to evidence-based medicine (EBM), as well as its controversies and limitations in the current health context. Our analysis utilizes two frameworks: (1) a complex adaptive view of health that sees both health and healthcare as non-linear phenomena emerging from their different components; and (2) the unified approach to the philosophy of science that provides a new background for understanding the differences between the phases of discovery, corroboration, and implementation in science. Results: The need for standardization, the development of clinical epidemiology, concerns about the economic sustainability of health systems and increasing numbers of clinical trials, together with the increase in the computer’s ability to handle large amounts of data, have paved the way for the development of the EBM movement. It was quickly adopted on the basis of authoritative knowledge rather than evidence of its own capacity to improve the efficiency and equity of health systems. The main problem with the EBM approach is the restricted and simplistic approach to scientific knowledge, which prioritizes internal validity as the major quality of the studies to be included in clinical guidelines. As a corollary, the preferred method for generating evidence is the explanatory randomized controlled trial. This method can be useful in the phase of discovery but is inadequate in the field of implementation, which needs to incorporate additional information including expert knowledge, patients’ values and the context. Conclusion: EBM needs to move forward and perceive health and healthcare as a complex interaction, i.e. an interconnected, non-linear phenomenon that may be better analysed using a variety of complexity science techniques. Keywords: Complexity of knowledge, Evidence-based medicine, Evidence-based practice, External validity, Framing, Generalizability, Internal validity, Randomized controlled trial Background 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 * Correspondence: 1 Brain and Mind Centre, Faculty of Health Sciences, The University of Sydney, 94 Mallett Street, Camperdown, NSW 2050, Australia Full list of author information is available at the end of the article 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 © 2015 Fernandez et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Fernandez et al. Health Research Policy and Systems (2015) 13:66 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 [3–8], epistemology [9–14], 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 [20–22]. 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 [25–27]. The unified approach to the philosophy of science provides a systematization of the basic (...truncated)