Journal of evaluation in clinical practice
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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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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.
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Review
The transition from inquiry to evidence to actionable clinical knowledge: A proposed roadmap.
We consider the question "What should we do?" in the context of clinical research/practice. There are several steps along the way to providing a satisfactory answer, many of which have received considerable attention in the literature. We aim to provide a unified summary and explication of these "steps along the way". The result will be an increased appreciation for the meaning and structure of "actionable clinical knowledge". ⋯ Clinical decision-making is not infallible, and the steps we can take to minimize error are context dependent. Medical evidence, produced as it is by human effort, can never be perfect. We will be doing well by assuring that the evidence we use has been produced by a reliable process and is relevant to the question posed.
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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.