Project Proposal

Aim

The aim of this project is to respond to the difficult philosophical questions raised by Evidence-Based Medicine (EBM) and the role it plays in healthcare decision-making.

Background

Over the last decade Evidence-based medicine (EBM) has been put forward, both from within the medical community and externally, as the principle paradigm within which medicine should be practiced. Evidence based medicine has been defined as the ‘conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients’ (1). Although proponents of EBM admit that all empirical evidence plays a role in medical decision-making, the central tenant of EBM is the ‘hierarchy of evidence’ founded on the methodology of experimental design. EBM’s hierarchy of evidence holds that large scale randomized controlled trials and meta-analyses provide ‘better’ evidence than case series on individual patients, individual physician experience and information from the basic sciences.

Precisely what EBM means, how it should be applied, and indeed whether it should be applied, is a matter of intense and often polemic debate (2, 3). This debate continues to be played out over a number of traditionally demarcated academic fields (and their differing subspecialties) including epidemiology, philosophy and biostatistics.

Proposed Research Program

Broadly speaking the questions raised by EBM which are immediately philosophical in nature, may be characterised as epistemological, probabilistic and ethical.

With regard to epistemology. Are the epistemic claims of EBM, particularly with respect to the hierarchy of evidence, justifiable? Do randomized controlled trials provide a greater access to truth than observational studies or pathophysiological rationale? If so, on what basis? Much of the literature arguing against the epistemological claims of EBM have been focused on highlighting the fallibility of large scale randomized controlled trials (2). This, in effect, aligns the problem of EBM to an application of the classic problems of philosophy of science ’ the exposition of the proper relationship between evidence, theory, extra-evidentiary input (e.g. value judgments and many others) and the aims of science (be they truth or instrumental utility). There is little philosophical or medical literature which has attempted to explore the epistemological claims of EBM within a more openly fallibilist account of EBM.

The second area of philosophical questions raised by the debates surrounding EBM are those of probability. If EBM is rightly taken as a fallible endeavour, then its epistemological claims rely on probabilism as a foundation for belief. This raises the question of how probability is best interpreted within EBM. This question has a number of applications within EBM both from the aspect of how best to design and interpret clinical trials as well as questions of how best to make decisions in healthcare given the context of the inescapable uncertainty underpinning all decisions. There an increasing recognition of these questions and the importance of debate in this area in both the philosophical and epidemiological literature (6-8).

The third main area of philosophical questions raised by EBM are normative: How should EBM be practiced and applied? This question can posed equally to the individual healthcare practitioners, the healthcare community as well as the funders of healthcare (state or otherwise). Although literature on this area of EBM is evolving (2, 3), precisely what direction the normative questions will take are dependant on the further development of the epistemological and probabilistic issues within EBM.

Ability of this project to make a significant contribution to public health and pharmacy practice research

‘Promoting and Maintaining Good Health’ is one of Australia’s four national research priority areas. In 2003 this research priority was broadened specifically to include research contributions from the social sciences and humanities in recognition of the need to promote multidisciplinary approaches to research which will promote health and prevent disease through a focused and collaborative effort. Currently, the central tenet for decision making in health care is the degree to which the proposed action or intervention is ‘evidence-based’. The key difficulty from both a philosophical and practical decision making standpoint is to define precisely what constitutes this evidence, and further, given how it is constituted, how such evidence may be prudently utilised. It is by mapping out how these questions may be answered that my proposed research project has the potential to make a significant contribution to this national research priority.

The contribution will be primarily achieved by presenting this research at key medical and Quality Use of Medicines conferences and publishing the key findings of the project in national and international peer-reviewed philosophy, epidemiology and practice-focused pharmacy and medical journals.

Epistemology and philosophy of science is an internationally recognised research strength of The University of Queensland Philosophy Department. This expertise, the recent development of the ARC funded Biohumanities Project combined with the established links with the Institute of Molecular Bioscience and my professional links with the School of Pharmacy and the broader QUM and pharmacy community make The University of Queensland the ideal place to complete this project.

Sackett DL, et al.BMJ 1996;312 (7023): 71-72. Guyatt GH, et al.British Medical Journal 2004;329: 990-991. Gupta M.J Eval Clin Pract 2003;9 (2): 111-121. Shahar E.J Eval Clin Pract 2003;9 (2): 151-159. Worrall J.Philosophy of Science 2002: 69(3 Supplement) S316-S330. Hill G, et al.Journal of Clinical Epidemiology 2000;53 (3): 223-227. Spiegelhalter DJ, et al.BMJ 1999;319 (7208): 508-512. Upshur REG.Theoretical Medicine and Bioethics 2001: 22(6) 565-576.