Advancing the evidence‐based healthcare debate

The present issue is the third and most comprehensive thematic edition of the Journal of Evaluation in Clinical Practice dedicated to a critical examination of the strengths and weaknesses of the concept and methods of evidence-based medicine (EBM) as they have evolved over the last five years of publication. In the first such edition The Limits of Evidence-based Medicine we expressed our concerns in relation to the nomenclature of EBM, the manner of its presentation by advocates and to its adoption of narrow scientism and pseudo-authority (see Miles et al. 1997 ). In the second edition Recent Progress in Health Services Research we delineated very clearly, and in unequivocal terms, the continuing unscientific and anti-scientific nature of EBM. Indeed, we suggested that the predilection for experimental novelty and rhetorical wordplay within health services would mean that the reductionism of evidence-based medicine would survive for some time, but that attempts permanently to institute a concept based on such unsure philosophical and methodological foundations would almost certainly result in its fall. At that time Charlton & Miles (1998), writing in the Quarterly Journal of Medicine, argued that if EBM in its form at that time did not fall spontaneously then it would need to be pushed. We are pleased in the present edition Advancing the Evidence-based Healthcare Debate to contribute further to that process but only in the constructive sense of pushing EBM from its absurd posture as a new paradigm and absolute source of authority and competency in clinical medical practice ( Couto 1998) into ‘its place’ as a technique of significant but limited utility within modern medicine ( Lancet 1995; Charlton 1997). At the time of writing, there are certainly signs of a ‘fall’ of EBM from its self-description of ‘new paradigm’, a fall from its absolute adherence to the randomized controlled trial and explicit denigration of clinical judgement and a fall from its insistence on the development of the individual clinician as sequential harvester, appraiser and user of database-derived clinical literature. Whether this highly significant shift in the position of the EBM community is occurring as a result of deeper philosophical consideration or simple pragmatism seems less clear. If the extensive international debates on EBM committed to the literature through the mechanism of the Journal have contributed to this change then we are, of course, gratified. Indeed, it is the duty of all scientists charged with editorial responsibility to place their journals at the centre of medical debate and we have been pleased to have adopted a ‘controversial, politically incorrect’ position if that is what it takes to achieve a rhetoric-free, intellectually balanced debate on the limitations and weaknesses, as well as strengths and benefits, of EBM. The present edition contains much that is striking and much that is of immediate significance to an advancement of the evidence-based healthcare debate. Callahan (1999: pp. 103–106), in a short but particularly insightful article, exhorts us to remember the goals of medicine, a paper which should read in conjunction with McIntyre’s essay on the principles of clinical practice ( McIntyre 1995). The contribution by the distinguished professor of clinical epidemiology Olli Miettinen ( Miettinen 1999: pp. 107–116) is a work of outstanding intellectual content and is thoroughly complemented by Gremy’s studied reflection on science, art and technique applied to medicine ( Gremy 1999: pp. 117–123). The article by Welsby (1999: pp. 125–131) juxtaposes reductionism in medicine with ‘holistic complexity appreciation’, finding both unsatisfactory as philosophies for clinical practice and recommending the establishment of a balance between the two. As such, it provides an excellent prelude to the substantial part of this edition dedicated to the concept and technique of evidence-based medicine, the codification of knowledge into clinical practice guidelines and the derivation and implementation of associated health policy. The paper by Ghali and associates ( Ghali et al. 1999 : pp. 133–138) is monumental (despite its opening arrogance) in documenting the collapse of ‘orthodox EBM’ and the emergence of a new liberalism which ipso facto demonstrates EBM to be entirely synonymous with good clinical practice and therefore not at all a new concept and most certainly not a new paradigm. Norman (1999 pp. 139–147), in his analysis of the assumptions of EBM, notes much of this and views consensus much more likely as a result. Importantly, Norman (1999) re-iterates what he, we and other colleagues have repeatedly emphasized in the Journal and elsewhere, that there remains absolutely no evidence for EBM and that the few studies which have been advanced in this context are subject to very considerable biases that render them inadmissible. Indeed, as Norman (1999) notes, ‘for the practitioners of EBM to continue to resort to appeals of ‘‘biological plausibility’’ as justification for EBM amounts to a tacit endorsement of the very practices that they themselves condemn’ (p.145). The central place of judgement and experience in good clinical practice is highlighted by Berk & Janet (1999: pp. 149–152) in their essay on evidence-based psychiatry. Their concern with the need to tailor care to the individual by limiting the rigidity of practice algorithms is shared by Herman (1999: pp. 153–156) who notes the lack of a ‘personal’ element in practice guidelines to allow for physicians’ varying goals and patients’ differing preferences. The complexities of extrapolating research studies to the consulting room are considered by Holmberg and associates ( Holmberg et al. 1999 : pp. 157–162). These authors discuss the major issues of generalization and representativeness with specific reference to the randomized controlled trial and conclude that inference from a clinical study is not only a question of statistical generalization but includes a ‘jump from the world of experiences into the world of reason, assessment and theoretical judgement’ (p. 160). In their preliminary communication, Phillips & coworkers ( Phillips et al. 1999 : pp. 163–168) document some well worn examples of bad clinical practice in describing the rationale for their study on the implementation and sustaining of evidence-based clinical practice in Australia. Co-ordinating studies of this type, if they are successful in ensuring the necessary experimental rigour, will help test some important facets of the currently untested hypothesis underpinning EBM. The codification of knowledge into clinical practice guidelines and the operational implementation and use of algorithmic guidance in the context of the consultation is the subject of six papers within the current edition. Merritt and colleagues ( Merritt et al. 1999 : pp. 169–177) present a critical evaluation of clinical practice guidelines for neonatal medicine and note that the question ‘Does their use improve quality and lower costs?’ cannot automatically be answered in the positive. Karp ( Karp 1999: pp. 179–187) and Vidal-Trecan and colleagues ( Vidal-Trecan et al. 1999 : pp. 189–198) work on the assumption that guidelines can certainly raise quality if not necessarily lower costs. These authors describe an essentially similar approach in developing clinical practice guidelines based on sound scientific evidence but remain centrally concerned to include peer-knowledge and experience and peer-approval before recommending the products for general use. Karp (1999) describes an important method for aligning practice with knowledge through use of a ‘workstation concept’ and Harris and associates ( Harris et al. 1999 : pp. 199–211) describe an innovative approach to disseminating clinical practice guidelines on the investigation and management of malignant melanoma to primary care physicians using the ubiquitous Internet. The matter of ‘compliance’ with guidelines is treated by Meng and coworkers ( Meng et al. 1999 : pp. 213–221) who note a failure of ‘compliance’ with the American National Asthma Education Program guidelines across their sample of seven American States. The authors suggest that dissemination of clinical practice guidelines should be extended to patients themselves in an effort to ensure access to ‘best’ care. The issue of implementation of professionally developed and endorsed guidelines into routine care across health regions and, indeed, the entirety of a given country, has been a particular concern within all health services and a great deal of effort and experimentation is currently being invested in identifying successful strategies where various interventions, probably employed in combination, may achieve successful use. Sturmberg (1999: pp. 223–226) reviews this common failure of implementation in terms of the personal characteristics of the individual clinician and a reading of his paper supports the view that more research is needed into how this very particular obstacle to change might be overcome. Two papers in this edition are dedicated to a discussion of evidence-based healthcare in the context of health policy research, development and implementation. Noseworthy & Watanabe (1999: pp. 227–242) present a highly detailed review of the policy and methodology adopted by the Canadian government focused on the creation of an ‘evidence-based healthcare’ culture in that country and describe the institution of a central organization, the Canadian Institute for Health Information, an organ destined to play a major role in achieving that aim. Willison & McLeod (1999: pp. 243–249) are concerned with the nature of evidence for policy decision making and the mechanics of its use. They note that, to date, the use of research evidence in policy making at legislative and administrative levels has proved selective at best. They discuss how the uptake of research evidence into policy might be increased and introduce some theoretical foundations from the social sciences to help to explain some of the gaps in the uptake of research evidence into policy making. Of particular interest to the reader will be their discussion of the rational model, incrementalist model and mixed scanning and normative optimal model of policy making. If the foundations of ‘new EBM’ are centred on the continuing concern to align clinical practice with the latest available knowledge then the concern of basic clinical scientists is to continue to provide such knowledge. It is in this context that Charlton ( Charlton 1999: pp. 251–263) notes a general deceleration of innovation since the 1960s. In a fascinating article certain to be viewed as highly controversial by the regulatory establishment, this author elegantly articulates what he regards as the most prominent obstacles to continued progress, suggesting methods of circumventing barriers to continued innovation and envisioning a future which would see the growth of a bottom up movement in which doctors form coalitions with patients to promote effective clinical science. A thorough commentary on each paper has been beyond the scope and page limits for this introduction. The individual articles speak lucidly and elegantly for themselves and the reader is referred to the published texts for a comprehensive up-date on the current debate surrounding, and progress in, the international EBM movement. The content of the constituent papers of this edition demonstrates that the debate on EBM is far from concluded with philosophical and methodological questions of central importance to the definition of exactly what constitutes ‘best professional practice’ remaining unanswered. In these circumstances, intellectually honest and intensive debate, stripped of rhetoric and idealism, is of quite vital importance to the development of clinical services of increased effectiveness and efficiency. It is in this spirit that we publish the present issue in advancement of the debate and dedicate this thematic edition to all colleagues passionately concerned with the preservation of the noble Hippocratic ideals that underpin medical practice.