Journal of evaluation in clinical practice
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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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The onset of acute illness may be accompanied by a profound sense of disorientation for patients. Addressing this vulnerability is a key part of a physician's purview, yet well-intended efforts to do so may be impeded by myriad competing tasks in clinical practice. Resolving this dilemma goes beyond appealing to altruism, as its limitless demands may lead to physician burnout, disillusionment, and a narrowed focus on the biomedical aspects of care in the interest of self-preservation. The authors propose an ethic of hospitality that may better guide physicians in attending to the comprehensive needs of patients that have entered "the kingdom of the sick." ⋯ While it is unlikely that anything physicians do will make the hospital a place where patients and caregivers will desire to be, hospitality may focus their efforts upon making it less unwelcoming. Specifically, it offers an orientation that supports patients in navigating the disorienting and unfamiliar terrains of acute illness, the hospital setting in which help is sought, and engagement with the health care system writ large.
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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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Parts 1 and 2 in this series of three articles have shown that and how strong evidence-based medicine has neither a coherent theoretical foundation nor creditable application to clinical practice. Because of its core commitment to the discredited positivist tradition it holds both a false concept of scientific knowledge and misunderstandings concerning clinical decision-making. Strong EBM continues attempts to use flawed adjustments to recover from the unsalvageable base view. ⋯ While most of papers 1, 2, and 3 are written in the classical mode of contrasting the theoretical-logical and empirical evidence offered by contending positions bearing on the decision making and judgement in clinical practice, a shift occurs when considerations move beyond what is possible for clinical practitioners to accomplish. A different, discontinuous level of power operates in the trans-personal realm of instrumental policy, insurance, and hospital management practices. In this social-economic-political-ethical realm what happens in clinical practice today increasingly becomes a matter of what is "done unto" clinical practitioners, of what hampers their professional action and thus care of individual patients and clients.