Journal of evaluation in clinical practice
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Evidence-based medicine (EBM), one of the most important movements in health care, has been a lightning rod for controversy. Conflicts about the meaning and value of EBM are owing in part to lack of clarity about basic questions regarding its development, the importance of expertise and intuition, and the role of evidence in clinical decision making. These issues have persisted in part because of unclarity at the outset, but also because of how EBM evolved, why it was introduced when it was, and how it was modified following its introduction. ⋯ The paper discusses the impact of this merger, in particular how it led to EBM's identification with managed care and has added momentum to the effort at forging a connection between a normative decision model and clinical judgement. This effort would turn clinical decision making into a conduit for bringing administrative rules and regulations into the consulting room and would result in expertise becoming a surplus skill. The paper closes by discussing a challenge yet unmet by EBM's advocates and critics-to chronicle the dangers that EBM in the framework of DA during the current era of industrialization poses to health and health care, and discover ways of unhinging the relationship between model and judgement.
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Randomized Controlled Trial
Distinctive aspects of consent in pilot and feasibility studies.
Prior to a main randomized clinical trial, investigators often carry out a pilot or feasibility study in order to test certain trial processes or estimate key statistical parameters, so as to optimize the design of the main trial and/or determine whether it can feasibly be run. Pilot studies reflect the design of the intended main trial, whereas feasibility studies may not do so, and may not involve allocation to different treatments. Testing relative clinical effectiveness is not considered an appropriate aim of pilot or feasibility studies. ⋯ Equipoise may also be particularly challenging to grasp in the context of a pilot study. The consent process in pilot and feasibility studies requires a particular focus, and careful communication, if it is to carry the appropriate moral weight. There are corresponding implications for the process of ethical approval.
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Evidence-based standards are fundamental to the practice, funding, and governance of modern medicine. These standards are developed using hierarchies of evidence yet it is often not appreciated that different hierarchies exist and there is a risk that inconsistent standards may be developed depending upon the hierarchy that is used. In this paper, we present four factors, independent of study design, that have led to differences amongst hierarchies. ⋯ We demonstrate that each of these factors has led to the upgrading of expert opinion and/or the downgrading of randomized controlled trials and meta-analyses within different hierarchies. Our aim is to raise awareness of factors that have influenced the development of hierarchies. This may make the reader more critical of the processes that are used to develop evidence based standards.
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In recent years there has been an explosion of interest in Artificial Intelligence (AI) both in health care and academic philosophy. This has been due mainly to the rise of effective machine learning and deep learning algorithms, together with increases in data collection and processing power, which have made rapid progress in many areas. However, use of this technology has brought with it philosophical issues and practical problems, in particular, epistemic and ethical. ⋯ The authors argue that, although effective current or future AI-enhanced EFM may impose an epistemic obligation on the part of clinicians to rely on such systems' predictions or diagnoses as input to SDM, such obligations may be overridden by inherited defeaters, caused by a form of algorithmic bias. The existence of inherited defeaters implies that the duty of care to the client's knowledge extends to any situation in which a clinician (or anyone else) is involved in producing training data for a system that will be used in SDM. Any future AI must be capable of assessing women individually, taking into account a wide range of factors including women's preferences, to provide a holistic range of evidence for clinical decision-making.
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Evidence-based medicine announced its entry as heralding a new paradigm in health care practices, but it has been widely criticized for lacking a coherent theoretical basis. This paper presents the first part of a three-article series examining the epistemological, practical, and ethical dimensions of strong EBM, as well as considering alternatives that promise potential solutions to chronic conceptual and practical problems. While the focus is on the details of the arguments and evidence in thoughtful debates over the last 30 years, it is worthwhile to keep in mind the overall trajectory of modern thought, because strong EBM continues discredited positivist positions, thus repeating its major assumptions and inadequacies, now transferred to the medical sphere and vocabulary. Part 1 of the series examines the development of strong EBM by clarifying and critiquing its somewhat discontinuous accounts of scientific knowledge and epistemology, evidence, the differences between statistical probability in regard to populations and understanding the health of individuals, and its claims for direct transfer of research findings to clinical settings-all of which raises more questions regarding its application to provider-patient decision making, pedagogy, and policy.