After more than a decade, evidence-based medicine (EBM) is well established as an important influence in health care. EBM has engendered a wide range of responses from near-evangelical fervor to angered rejection, with supporters convinced of its scientific superiority and detractors of its needless reductionism. EBM is not a philosophical doctrine, and its originators and proponents have, for the most part, ignored critics and foresworn theorizing. However, EBM claims to be a normative guide to being a better physician. The theoretical, practical, and philosophical dimensions of EBM are intimately intertwined. This essay is a sustained reflection on the issues raised by EBM as experienced by a clinician/teacher who has tried to apply the tenets of EBM in clinical care and teaching over the past decade, and who has sought to expand the borders of EBM from a philosophical point of view.
Clinical medicine -- Moral and ethical aspects -- United States.
Evidence-based medicine (EBM) aims to address the persistent problem of clinical practice variation with the help of various tools, including standardized practice guidelines. Based on a systematic evaluation of the available scientific evidence, these guidelines offer recommendations for clinicians about details of patient care and clinical decision making. Because clinical practice guidelines specify how health care should be performed, they could be considered a threat to clinical and professional autonomy. Inspired by the theory of countervailing powers, this article explores how clinical practice guidelines have shifted the focus of professional power from autonomy to accountability. Professional organizations develop clinical practice guidelines as a service to their members but do not require strict adherence to the guidelines. Indeed, implementation studies show at best a modest change in clinical behavior. Such non-adherence might render a profession vulnerable, however, when third parties seize upon guidelines and offer financial incentives to keep clinicians accountable for delivering optimal patient care.
The validity of evidence-based medicine (EBM) is the subject of ongoing controversy. The EBM movement has proposed a "hierarchy of evidence," according to which randomized controlled trials (RCTs) and meta-analyses of RCTs provide the most reliable evidence concerning the efficacy of medical interventions. The evaluation of alternative medicine therapies highlights problems with the EBM hierarchy. Alternative medical researchers—like those in mainstream medicine—wish to evaluate their therapies using methods that are rigorous and that are consistent with their philosophies of medicine and healing. These investigators have three ways to relate their work to EBM. They can accept the EBM hierarchy and carry out RCTs when possible; they can accept the EBM standards but argue that the special characteristics of alternative medicine warrant the acceptance of "lower" forms of evidence; or they can challenge the EBM approach and work to develop new research designs and new standards of evidence that reflect their approach to medical care. For several reasons, this last option is preferable. First, it will best meet the needs of alternative medicine practitioners. Moreover, because similar problems beset the evaluation of mainstream medical therapies, reevaluation of standards of evidence will benefit everyone in the medical community—including, most importantly, patients.
The randomized controlled trial (RCT) is not a gold standard: it is a good experimental design in some circumstances, but that's all. Potential shortcomings in the design and implementation of RCTs are often mentioned in passing, yet most researchers consider that RCTs are always superior to all other types of evidence. This paper examines the limitations of RCTs and shows that some types of evidence commonly supposed to be inferior to all RCTs are actually superior to many. This has important consequences for research methodology, for quality of care in clinical medicine, and—especially—for research funding policy. Because every study design may have problems in particular applications, studies should be evaluated by appropriate criteria, and not primarily according to the simplistic RCT/non-RCT dichotomy promoted by some prominent advocates of the evidence-based medicine movement and by the research evaluation guidelines based on its principles.
Evidence-based medicine (EBM) advocates the improvement of patient care through the use of current best research evidence in medical decision making. In practice, "best evidence" generally refers to where a study fits on a hierarchy of evidence, which places randomized controlled trials (RCTs) and other population-level research above laboratory research. Because population research is concerned primarily with average results obtained from large groups of people, ranking evidence on the basis of its place in the hierarchy is shortsighted and ultimately limits the ability of research results to inform the care of individual patients. The history and methodology of epidemiology reveals a close relationship between population-level and laboratory research; both types of research are necessary if we are to understand the causes of a disease. What EBM does not take into account in its hierarchy of evidence is that the same thing is true for research on the safety and efficacy of medical interventions. To maximize the information that clinical research can provide for clinical care, RCTs should be designed to elucidate within-group variability. This can only be done if the hierarchy of evidence is replaced by a network that takes into account the relationship between epidemiological and laboratory research.
Evidence-based medicine -- Moral and ethical aspects -- United States.
Clinical trials -- Moral and ethical aspects -- United States.
The growth of evidence-based medicine (EBM) raises a number of ethical issues that have too often been overlooked. These include issues that arise when clinicians make judgments under uncertainty, new challenges for the clinician-patient relationship, new duties for institutional review boards, issues in physician autonomy and reimbursement, and challenges for disclosure and informed consent. Ethics and EBM must be addressed by policy makers and integrated into medical education.
Evidence-based medicine -- Moral and ethical aspects -- United States.
Public health -- United States.
Public health researchers, policy makers, and practitioners agree that health is the outcome of interactions between biological, behavioral, and social determinants. Nonetheless, institutional patterns of research funding and practice remain obstacles to generating research at and between each of these levels. These practices are embedded in historic assumptions about the nature of reality and how it can best be understood. Current debates over the criteria for evaluating public health research have centered on the applicability of the clinical evidence-based medicine (EBM) model to the field of public health. The EBM hierarchy, which is based on traditional scientific assumptions about causality, is insufficient and potentially harmful as the basis for evaluating research on the determinants of health. Yet those who have put forward a critique of EBM have failed to develop a plausible alternative. Critical realism, based on the philosophy of Roy Bhaskar, may provide a way out of the current stalemate, enabling public health researchers from various disciplines and research paradigms to work together, bringing the full weight of scientific knowledge to bear on increasingly complex and global public health problems.
Miller, Franklin G.