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  1. Why Experimental Balance is Still a Reason to Randomize.David Teira & Marco Martinez - forthcoming - The British Journal for the Philosophy of Science.
    Experimental balance is usually understood as the control for the value of the conditions, other than the one under study, which are liable to affect the result of a test. We will discuss three different approaches to balance. ‘Millean balance’ requires to identify and equalize ex ante the value of these conditions in order to conduct solid causal inferences. ‘Fisherian balance’ measures ex post the influence of uncontrolled conditions through the analysis of variance. In ‘efficiency balance’ the value of the (...)
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  2. Probability and Informed Consent.Nir Ben-Moshe, Benjamin A. Levinstein & Jonathan Livengood - 2023 - Theoretical Medicine and Bioethics 44 (6):545-566.
    In this paper, we illustrate some serious difficulties involved in conveying information about uncertain risks and securing informed consent for risky interventions in a clinical setting. We argue that in order to secure informed consent for a medical intervention, physicians often need to do more than report a bare, numerical probability value. When probabilities are given, securing informed consent generally requires communicating how probability expressions are to be interpreted and communicating something about the quality and quantity of the evidence for (...)
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  3. A Wolf in Sheep's Clothing: Idealisations and the aims of polygenic scores.Davide Serpico - 2023 - Studies in History and Philosophy of Science Part A 102 (C):72-83.
    Research in pharmacogenomics and precision medicine has recently introduced the concept of Polygenic Scores (PGSs), namely, indexes that aggregate the effects that many genetic variants are predicted to have on individual disease risk. The popularity of PGSs is increasing rapidly, but surprisingly little attention has been paid to the idealisations they make about phenotypic development. Indeed, PGSs rely on quantitative genetics models and methods, which involve considerable theoretical assumptions that have been questioned on various grounds. This comes with epistemological and (...)
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  4. Simulation of Trial Data to Test Speculative Hypotheses about Research Methods.Hamed Tabatabaei Ghomi & Jacob Stegenga - 2023 - In Kristien Hens & Andreas De Block (eds.), Advances in Experimental Philosophy of Medicine. London: Bloomsbury. pp. 111-128.
    We simulate trial data to test speculative claims about research methods, such as the impact of publication bias.
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  5. What evidence for a cholera vaccine? Jaime Ferrán’s submissions to the Prix Bréant.David Teira & Clara Uzcanga - 2023 - Journal of the History of Medicine and Allied Sciences.
    This article analyses how the French Academy of Sciences assessed Jaime Ferrán’s cholera vaccine submitted for the Prix Bréant in the 1880s. Ferrán, a Spanish independent physician, discovered the treatment in 1884 and tried it on thousands of patients during the cholera outbreak in Valencia the following year. His evaluation sparked a controversy in Spain and abroad on the vaccine’s efficacy. The Bréant jury did not see any evidence for it in Ferrán’s submission, a decision usually interpreted in terms of (...)
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  6. Inconvenient Truth and Inductive Risk in Covid-19 Science.Eli I. Lichtenstein - 2022 - Philosophy of Medicine 3 (1):1-25.
    To clarify the proper role of values in science, focusing on controversial expert responses to Covid-19, this article examines the status of (in)convenient hypotheses. Polarizing cases like health experts downplaying mask efficacy to save resources for healthcare workers, or scientists dismissing “accidental lab leak” hypotheses in view of potential xenophobia, plausibly involve modifying evidential standards for (in)convenient claims. Societies could accept that scientists handle (in)convenient claims just like nonscientists, and give experts less political power. Or societies could hold scientists to (...)
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  7. 16 The logic of lockdowns: a game of modeling and evidence.Wesley J. Park - 2022 - BMJ Evidence-Based Medicine 27 (Suppl 1):A59.
    Lockdowns, or modern quarantines, involve the use of novel restrictive non-pharmaceutical interventions (NPIs) to suppress the transmission of COVID-19. In this paper, I aim to critically analyze the emerging history and philosophy of lockdowns, with an emphasis on the communication of health evidence and risk for informing policy decisions. I draw a distinction between evidence-based and modeling-based decision-making. I argue that using the normative framework of evidence-based medicine would have recommended against the use of lockdowns. I first review the World (...)
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  8. 175 An ethical analysis of evidence-based medicine.Wesley J. Park - 2022 - BMJ Evidence-Based Medicine 27 (Suppl 1):A48.
    Evidence-based medicine is a clinical decision-making framework which makes claims about what physicians ought to do. Though heralded as the cutting edge of medical science, evidence-based medicine is a value-laden normative theory which implicitly depends on substantive views regarding what is morally good or right. In this paper, I provide an ethical analysis of evidence-based medicine. I consider its normative underpinnings in three ethical theories: utilitarianism, Kantian deontology, and virtue ethics. In the face of uncertainty, evidence-based medicine endorses expected utility (...)
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  9. 143 An ethical analysis of evidence-based medicine.Wesley J. Park - 2022 - BMJ Evidence-Based Medicine 27 (Suppl 2):A12.
    Evidence-based medicine is a clinical decision making framework which makes claims about what physicians ought to do. Though heralded as the cutting edge of medical science evidence-based medicine is a value laden normative theory which implicitly depends on substantive views regarding what is morally good or right. In this paper, I provide an ethical analysis of evidence-based medicine. I consider its normative underpinnings in three ethical theories: utilitarianism, Kantian deontology, and virtue ethics. In the face of uncertainty, evidence-based medicine endorses (...)
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  10. Relaxing Mask Mandates in New Jersey: A Tale of Two Universities.Wesley J. Park - 2022 - Voices in Bioethics 8.
    The ethical question is whether university mask mandates should be relaxed. I argue that the use of face masks by healthy individuals has uncertain benefits, which potential harms may outweigh, and should therefore be voluntary. Systematic reviews by the World Health Organization (WHO) and Cochrane Acute Respiratory Infections concluded that the use of face masks by healthy individuals in the community lacks effectiveness in reducing viral transmission based on moderate-quality evidence. The only two randomized controlled trials of face masks published (...)
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  11. COVID-19 and the unseen pandemic of child abuse.Wesley J. Park & Kristen A. Walsh - 2022 - BMJ Paediatrics Open 6 (1).
    For children, the collateral damage of the COVID-19 pandemic response has been considerable. In this paper, we use the framework of evidence-based medicine to argue that child abuse is another negative side effect of COVID-19 lockdowns. While it was certain that school closures would have profound social and economic costs, it remains uncertain whether they have any effect on COVID-19 transmission. There is emerging evidence that lockdowns significantly worsened child abuse on a global scale. Low-income and middle-income countries are particularly (...)
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  12. Cognitive biases and the predictable perils of the patient‐centric free‐market model of medicine.Michael J. Shaffer - 2022 - Metaphilosophy 53 (4):446-456.
    This paper addresses the recent rise of the use of alternative medicine in Western countries. It offers a novel explanation of that phenomenon in terms of cognitive and economic factors related to the free-market and patient-centric approach to medicine that is currently in place in those countries, in contrast to some alternative explanations of this phenomenon. Moreover, the paper addresses this troubling trend in terms of the serious harms associated with the use of alternative medical modalities. The explanatory theory defended (...)
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  13. Red herrings about relative measures: A response to Hoefer and Krauss.Jacob Stegenga - 2022 - Studies in History and Philosophy of Science Part A 92 (C):56-59.
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  14. Evidence of effectiveness.Jacob Stegenga - 2022 - Studies in History and Philosophy of Science Part A 91 (C):288-295.
    There are two competing views regarding the role of mechanistic knowledge in inferences about the effectiveness of interventions. One view holds that inferences about the effectiveness of interventions should be based only on data from population-level studies (often statistical evidence from randomised trials). The other view holds that such inferences must be based in part on mechanistic evidence. The competing views are local principles of inference, the plausibility of which can be assessed by a more general normative principle of inference. (...)
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  15. Applying Evidential Pluralism to the Social Sciences.Yafeng Shan & Jon Williamson - 2021 - European Journal for Philosophy of Science 11 (4):1-27.
    Evidential Pluralism maintains that in order to establish a causal claim one normally needs to establish the existence of an appropriate conditional correlation and the existence of an appropriate mechanism complex, so when assessing a causal claim one ought to consider both association studies and mechanistic studies. Hitherto, Evidential Pluralism has been applied to medicine, leading to the EBM+ programme, which recommends that evidence-based medicine should systematically evaluate mechanistic studies alongside clinical studies. This paper argues that Evidential Pluralism can also (...)
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  16. Medical Nihilism by Jacob Stegenga: What is the right dose? [REVIEW]Jonathan Fuller - 2020 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 81.
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  17. Randomized Controlled Trials for Diagnostic Imaging: Conceptual and Pratical Problems.Elisabetta Lalumera & Stefano Fanti - 2019 - Topoi 38 (2):395-400.
    We raise a problem of applicability of RCTs to validate nuclear diagnostic imaging tests. In spite of the wide application of PET and other similar techniques that use radiopharmaceuticals for diagnostic purposes, RCT-based evidence on their validity is sparse. We claim that this is due to a general conceptual problem that we call Prevalence of Treatment, which arises in connection with designing RCTs for testing any diagnostic procedure in the present context of medical research, and is particularly apparent in this (...)
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  18. An epistemological problem for integration in EBM.Sasha Lawson-Frost - 2019 - Journal of Evaluation in Clinical Practice 25 (6):938-942.
    Evidence-based medicine (EBM) calls for medical practitioners to “integrate” our best available evidence into clinical practice. A significant amount of the literature on EBM takes this integration to be unproblematic, focusing on questions like how to interpret evidence and engage with patient values, rather than critically looking at how these features of EBM can be implemented together. Other authors have also commented on this gap in the literature, for example, identifying the lack of clarity about how patient preferences and evidence (...)
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  19. Warranted Diagnosis.David Limbaugh, David Kasmier, Werner Ceusters & Barry Smith - 2019 - In Proceedings of the International Conference on Biomedical Ontology (ICBO), Buffalo, NY. Buffalo: pp. 1-10.
    A diagnostic process is an investigative process that takes a clinical picture as input and outputs a diagnosis. We propose a method for distinguishing diagnoses that are warranted from those that are not, based on the cognitive processes of which they are the outputs. Processes designed and vetted to reliably produce correct diagnoses will output what we shall call ‘warranted diagnoses’. The latter are diagnoses that should be trusted even if they later turn out to have been wrong. Our work (...)
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  20. Rules versus Standards: What Are the Costs of Epistemic Norms in Drug Regulation?David Teira & Mattia Andreoletti - 2019 - Science, Technology, and Human Values 44 (6):1093-1115.
    Over the last decade, philosophers of science have extensively criticized the epistemic superiority of randomized controlled trials for testing safety and effectiveness of new drugs, defending instead various forms of evidential pluralism. We argue that scientific methods in regulatory decision-making cannot be assessed in epistemic terms only: there are costs involved. Drawing on the legal distinction between rules and standards, we show that drug regulation based on evidential pluralism has much higher costs than our current RCT-based system. We analyze these (...)
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  21. Drug Regulation and the Inductive Risk Calculus.Jacob Stegenga - 2017 - In Kevin Elliott & Ted Richards (eds.), Exploring Inductive Risk. New York: Oxford University Press. pp. 17-36.
    Drug regulation is fraught with inductive risk. Regulators must make a prediction about whether or not an experimental pharmaceutical will be effective and relatively safe when used by typical patients, and such predictions are based on a complex, indeterminate, and incomplete evidential basis. Such inductive risk has important practical consequences. If regulators reject an experimental drug when it in fact has a favourable benefit/harm profile, then a valuable intervention is denied to the public and a company’s material interests are needlessly (...)
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  22. Evidence based or person centered? An ontological debate.Rani Lill Anjum - 2016 - European Journal for Person Centered Healthcare 4 (2):421-429.
    Evidence based medicine (EBM) is under critical debate, and person centered healthcare (PCH) has been proposed as an improvement. But is PCH offered as a supplement or as a replacement of EBM? Prima facie PCH only concerns the practice of medicine, while the contended features of EBM also include methods and medical model. I here argue that there are good philosophical reasons to see PCH as a radical alternative to the existing medical paradigm of EBM, since the two seem committed (...)
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  23. Evaluating Normative Epistemic Frameworks in Medicine: EBM and Casuistic Medicine.Emily Bingeman - 2016 - Journal of Evaluation in Clinical Practice 22 (4):490-495.
    Since its inception in the early 1990s, evidence-based medicine (EBM) has become the dominant epistemic framework for Western medical practice. However, in light of powerful criticisms against EBM, alternatives such as casuistic medicine have been gaining support in both the medical and philosophical community. In the absence of empirical evidence in support of the claim that EBM improves patient outcomes, and in light of considerations that it is unlikely that such evidence will be forthcoming, another standard is needed to assess (...)
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  24. How norms make causes.Maria Kronfeldner - 2014 - International Journal of Epidemiology 43:1707–1713.
    This paper is on the problem of causal selection and comments on Collingwood's classic paper "The so-called idea of causation". It discusses the relevance of Collingwood’s control principle in contemporary life sciences and defends that it is not the ability to control, but the willingness to control that often biases us towards some rather than other causes of a phenomenon. Willingness to control is certainly only one principle that influences causal selection, but it is an important one. It shows how (...)
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  25. Book Review Jeremy Howick , The Philosophy of Evidence-Based Medicine . Chichester: Wiley-Blackwell (2011), 248 pp., $61.95 (paper). [REVIEW]Alex Broadbent - 2013 - Philosophy of Science 80 (1):165-168.
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  26. On the impartiality of early British clinical trials.David Teira - 2013 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 44 (3):412-418.
    Did the impartiality of clinical trials play any role in their acceptance as regulatory standards for the safety and efficacy of drugs? According to the standard account of early British trials in the 1930s and 1940s, their impartiality was just rhetorical: the public demanded fair tests and statistical devices such as randomization created an appearance of neutrality. In fact, the design of the experiment was difficult to understand and the British authorities took advantage of it to promote their own particular (...)
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  27. Randomized Controlled Trials and the Flow of Information: Comment on Cartwright.Sherrilyn Roush - 2009 - Philosophical Studies 143 (1):137-145.
    The transferability problem—whether the results of an experiment will transfer to a treatment population—affects not only Randomized Controlled Trials but any type of study. The problem for any given type of study can also, potentially, be addressed to some degree through many different types of study. The transferability problem for a given RCT can be investigated further through another RCT, but the variables to use in the further experiment must be discovered. This suggests we could do better on the epistemological (...)
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