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  1. Patient-Specific Devices and Population-Level Evidence: Evaluating Therapeutic Interventions with Inherent Variation.Mary Jean Walker - 2018 - Medicine, Health Care and Philosophy 21 (3):335-345.
    Designing and manufacturing medical devices for specific patients is becoming increasingly feasible with developments in 3D printing and 3D imaging software. This raises the question of how patient-specific devices can be evaluated, since our ‘gold standard’ method for evaluation, the randomised controlled trial, requires that an intervention is standardised across a number of individuals in an experimental group. I distinguish several senses of patient-specific device, and focus the discussion on understanding the problem of variations between instances of an intervention for (...)
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  • Corroborating Evidence‐Based Medicine.Alexander Mebius - 2014 - Journal of Evaluation in Clinical Practice 20 (6):915-920.
    Proponents of evidence-based medicine have argued convincingly for applying this scientific method to medicine. However, the current methodological framework of the EBM movement has recently been called into question, especially in epidemiology and the philosophy of science. The debate has focused on whether the methodology of randomized controlled trials provides the best evidence available. This paper attempts to shift the focus of the debate by arguing that clinical reasoning involves a patchwork of evidential approaches and that the emphasis on evidence (...)
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  • Establishing Causal Claims in Medicine.Jon Williamson - 2019 - International Studies in the Philosophy of Science 32 (1):33-61.
    Russo and Williamson put forward the following thesis: in order to establish a causal claim in medicine, one normally needs to establish both that the putative cause and putative effect are appropriately correlated and that there is some underlying mechanism that can account for this correlation. I argue that, although the Russo-Williamson thesis conflicts with the tenets of present-day evidence-based medicine, it offers a better causal epistemology than that provided by present-day EBM because it better explains two key aspects of (...)
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  • Evidence and the Assessment of Causal Relations in the Health Sciences.Raffaella Campaner & Maria Carla Galavotti - 2012 - International Studies in the Philosophy of Science 26 (1):27 - 45.
    This contribution claims that the two fundamental notions of causation at work in the health sciences are manipulative and mechanistic, and investigates what kinds of evidence matter for the assessment of causal relations. This article is a development of our 2007 article, ?Plurality of Causality?, where we argue for a pluralistic account of causation with an eye to econometrics and a single medical example. The present contribution has a wider focus, and considers the notion of evidence within a whole range (...)
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  • Evaluating Evidential Pluralism in Epidemiology: Mechanistic Evidence in Exposome Research.Stefano Canali - 2019 - History and Philosophy of the Life Sciences 41 (1):4.
    In current philosophical discussions on evidence in the medical sciences, epidemiology has been used to exemplify a specific version of evidential pluralism. According to this view, known as the Russo–Williamson Thesis, evidence of both difference-making and mechanisms is produced to make causal claims in the health sciences. In this paper, I present an analysis of data and evidence in epidemiological practice, with a special focus on research on the exposome, and I cast doubt on the extent to which evidential pluralism (...)
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  • Problems with Using Mechanisms to Solve the Problem of Extrapolation.Jeremy Howick, Paul Glasziou & Jeffrey K. Aronson - 2013 - Theoretical Medicine and Bioethics 34 (4):275-291.
    Proponents of evidence-based medicine and some philosophers of science seem to agree that knowledge of mechanisms can help solve the problem of applying results of controlled studies to target populations (‘the problem of extrapolation’). We describe the problem of extrapolation, characterize mechanisms, and outline how mechanistic knowledge might be used to solve the problem. Our main thesis is that there are four often overlooked problems with using mechanistic knowledge to solve the problem of extrapolation. First, our understanding of mechanisms is (...)
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  • Grading the Quality of Evidence of Mechanisms.Stefan Dragulinescu - 2018 - Dissertation, University of Kent
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  • New Directions in Philosophy of Medicine.Jacob Stegenga, Ashley Kennedy, Serife Tekin, Saana Jukola & Robyn Bluhm - forthcoming - In James Marcum (ed.), Bloomsbury Companion to Contemporary Philosophy of Medicine. Bloomsbury Academic. pp. 343-367.
    The purpose of this chapter is to describe what we see as several important new directions for philosophy of medicine. This recent work (i) takes existing discussions in important and promising new directions, (ii) identifies areas that have not received sufficient and deserved attention to date, and/or (iii) brings together philosophy of medicine with other areas of philosophy (including bioethics, philosophy of psychiatry, and social epistemology). To this end, the next part focuses on what we call the “epistemological turn” in (...)
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  • Complex Underdetermination and the Units of Clinical Translation.Spencer Phillips Hey - 2015 - Theoria : An International Journal for Theory, History and Fundations of Science 30 (2):207-227.
    What makes a high-quality biomarker experiment? The success of personalized medicine hinges on the answer to this question. Unfortunately, as many commentators have now emphasized, the quality of most biomarker experiments to date has been quite low. Although the technical side of this problem has received considerable attention, the philosophical issues remain largely unexplored. In this paper, I argue that understanding what constitutes a high-quality biomarker experiment requires some fundamental shifts in how we think about the epistemology, ontology, and methodology (...)
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  • The Risk GP Model: The Standard Model of Prediction in Medicine.Jonathan Fuller & Luis J. Flores - 2015 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 54:49-61.
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  • Measuring Effectiveness.Jacob Stegenga - 2015 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 54:62-71.
    Measuring the effectiveness of medical interventions faces three epistemological challenges: the choice of good measuring instruments, the use of appropriate analytic measures, and the use of a reliable method of extrapolating measures from an experimental context to a more general context. In practice each of these challenges contributes to overestimating the effectiveness of medical interventions. These challenges suggest the need for corrective normative principles. The instruments employed in clinical research should measure patient-relevant and disease-specific parameters, and should not be sensitive (...)
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  • Down with the Hierarchies.Jacob Stegenga - 2014 - Topoi 33 (2):313-322.
    Evidence hierarchies are widely used to assess evidence in systematic reviews of medical studies. I give several arguments against the use of evidence hierarchies. The problems with evidence hierarchies are numerous, and include methodological shortcomings, philosophical problems, and formal constraints. I argue that medical science should not employ evidence hierarchies, including even the latest and most-sophisticated of such hierarchies.
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  • Mechanisms and Difference-Making.Stefan Dragulinescu - 2016 - Acta Analytica 32 (1):29-54.
    I argue that difference-making should be a crucial element for evaluating the quality of evidence for mechanisms, especially with respect to the robustness of mechanisms, and that it should take central stage when it comes to the general role played by mechanisms in establishing causal claims in medicine. The difference-making of mechanisms should provide additional compelling reasons to accept the gist of Russo-Williamson thesis and include mechanisms in the protocols for Evidence-Based Medicine, as the EBM+ research group has been advocating.
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  • Hierarchies of Evidence in Evidence-Based Medicine.Christopher J. Blunt - 2015 - Dissertation, London School of Economics
    Hierarchies of evidence are an important and influential tool for appraising evidence in medicine. In recent years, hierarchies have been formally adopted by organizations including the Cochrane Collaboration [1], NICE [2,3], the WHO [4], the US Preventive Services Task Force [5], and the Australian NHMRC [6,7]. The development of such hierarchies has been regarded as a central part of Evidence-Based Medicine, a movement within healthcare which prioritises the use of epidemiological evidence such as that provided by Randomised Controlled Trials. Philosophical (...)
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  • What Counts as 'What Works': Expertise, Mechanisms and Values in Evidence-Based Medicine.Sarah Wieten - 2018 - Dissertation, Durham University
    My doctoral project is a study of epistemological and ethical issues in Evidence-Based Medicine, a movement in medicine which emphasizes the use of randomized controlled trials. Much of the research on EBM suggests that, for a large part of the movement's history, EBM considered expertise, mechanisms, and values to be forces contrary to its goals and has sought to remove them, both from medical research and from the clinical encounter. I argue, however, that expertise, mechanisms and values have important epistemological (...)
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  • Is EBM an Appropriate Model for Research Into the Effectiveness of Psychotherapy?Sydney Hovda - 2019 - Topoi 38 (2):401-409.
    EBM, and the hierarchy of evidence it prescribes, is a controversial model when it comes to research into the effectiveness of psychotherapeutic treatments. This is due in part to the so-called ‘Dodo Bird verdict’, which claims that all psychotherapies are equally effective, and that their effectiveness is largely due to the placebo effect. In response to this controversy, I argue that EBM can nevertheless be made to fit research into the effectiveness of psychotherapy, once a piecemeal approach to conducting RCTs (...)
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  • Philosophical Controversies in the Evaluation of Medical Treatments : With a Focus on the Evidential Roles of Randomization and Mechanisms in Evidence-Based Medicine.Alexander Mebius - 2015 - Dissertation, KTH Royal Institute of Technology
    This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares the alleged (...)
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  • Epistemology of Causal Inference in Pharmacology: Towards a Framework for the Assessment of Harms.Juergen Landes, Barbara Osimani & Roland Poellinger - 2018 - European Journal for Philosophy of Science 8 (1):3-49.
    Philosophical discussions on causal inference in medicine are stuck in dyadic camps, each defending one kind of evidence or method rather than another as best support for causal hypotheses. Whereas Evidence Based Medicine advocates the use of Randomised Controlled Trials and systematic reviews of RCTs as gold standard, philosophers of science emphasise the importance of mechanisms and their distinctive informational contribution to causal inference and assessment. Some have suggested the adoption of a pluralistic approach to causal inference, and an inductive (...)
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  • Reinforced Reasoning in Medicine.Daniel Auker‐Howlett & Michael Wilde - 2020 - Journal of Evaluation in Clinical Practice 26 (2):458-464.
    Some philosophers have argued that evidence of underlying mechanisms does not provide evidence for the effectiveness of a medical intervention. One such argument appeals to the unreliability of mechanistic reasoning. However, mechanistic reasoning is not the only way that evidence of mechanisms might provide evidence of effectiveness. A more reliable type of reasoning may be distinguished by appealing to recent work on evidential pluralism in the epistemology of medicine. A case study from virology provides an example of this so‐called reinforced (...)
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  • EnviroGenomarkers: The Interplay Between Mechanisms and Difference Making in Establishing Causal Claims.Federica Russo & Jon Williamson - 2012 - Medicine Studies 3 (4):249-262.
    According to Russo and Williamson :157–170, 2007, Hist Philos Life Sci 33:389–396, 2011a, Philos Sci 1:47–69, 2011b), in order to establish a causal claim of the form, ‘C is a cause of E’, one typically needs evidence that there is an underlying mechanism between C and E as well as evidence that C makes a difference to E. This thesis has been used to argue that hierarchies of evidence, as championed by evidence-based movements, tend to give primacy to evidence of (...)
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  • Judging Quality and Coordination in Biomarker Diagnostic Development.Spencer Phillips Hey - 2015 - Theoria: Revista de Teoría, Historia y Fundamentos de la Ciencia 30 (2):207-227.
    What makes a high-quality biomarker experiment? The success of personalized medicine hinges on the answer to this question. In this paper, I argue that judgment about the quality of biomarker experiments is mediated by the problem of theoretical underdetermination. That is, the network of biological and pathophysiological theories motivating a biomarker experiment is sufficiently complicated that it often frustrates valid interpretation of the experimental results. Drawing on a case-study in biomarker diagnostic development from neurooncology, I argue that this problem of (...)
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  • Epistemology of Causal Inference in Pharmacology: Towards a Framework for the Assessment of Harms.Jürgen Landes, Barbara Osimani & Roland Poellinger - 2018 - European Journal for Philosophy of Science 8 (1):3-49.
    Philosophical discussions on causal inference in medicine are stuck in dyadic camps, each defending one kind of evidence or method rather than another as best support for causal hypotheses. Whereas Evidence Based Medicine advocates the use of Randomised Controlled Trials and systematic reviews of RCTs as gold standard, philosophers of science emphasise the importance of mechanisms and their distinctive informational contribution to causal inference and assessment. Some have suggested the adoption of a pluralistic approach to causal inference, and an inductive (...)
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  • Evidence for Personalised Medicine: Mechanisms, Correlation, and New Kinds of Black Box.Mary Jean Walker, Justin Bourke & Katrina Hutchison - 2019 - Theoretical Medicine and Bioethics 40 (2):103-121.
    Personalised medicine has been discussed as a medical paradigm shift that will improve health while reducing inefficiency and waste. At the same time, it raises new practical, regulatory, and ethical challenges. In this paper, we examine PM strategies epistemologically in order to develop capacities to address these challenges, focusing on a recently proposed strategy for developing patient-specific models from induced pluripotent stem cells so as to make individualised treatment predictions. We compare this strategy to two main PM strategies—stratified medicine and (...)
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  • Disentangling Mechanisms From Causes: And the Effects on Science.John Protzko - 2018 - Foundations of Science 23 (1):37-50.
    Despite the miraculous progress of science—it’s practitioners continue to run into mistakes, either discrediting research unduly or making leaps of causal inference where none are warranted. In this we isolate two of the reasons for such behavior involving the misplaced understanding of the role of mechanisms and mechanistic knowledge in the establishment of cause-effect relationships. We differentiate causal knowledge into causes, effects, mechanisms, cause-effect relationships, and causal stories. Failing to understand the role of mechanisms in this picture, including their absence (...)
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  • Methodological Strategies in Microbiome Research and Their Explanatory Implications.Maureen A. O’Malley & Derek J. Skillings - 2018 - Perspectives on Science 26 (2):239-265.
    Microbiome research is the analysis of the aggregated molecular components of a defined microbial community.1 Our examination of this field will focus on how causality is assigned in microbiome analyses, and what methodological strategies are used to identify communities or components of those communities as causal contributors to host states. Earlier microbiome research was conducted at a broad scale via bio informatic analyses of environmental samples, then backed up by whole community transfer experiments. These "top-down" findings, in which the whole (...)
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  • Research Gaps in the Philosophy of Evidence‐Based Medicine.Alexander Mebius, Ashley Graham Kennedy & Jeremy Howick - 2016 - Philosophy Compass 11 (11):757-771.
    Increasing philosophical attention is being directed to the rapidly growing discipline of evidence-based medicine. Philosophical discussions of EBM, however, remain narrowly focused on randomization, mechanisms, and the sociology of EBM. Other aspects of EBM have been all but ignored, including the nature of clinical reasoning and the question of whether it can be standardized; the application of EBM principles to the logic, value, and ethics of diagnosis and prognosis; evidence synthesis ; and the nature and ethics of placebo controls. Philosophical (...)
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  • Informing materials: drugs as tools for exploring cancer mechanisms and pathways.Etienne Vignola-Gagné, Peter Keating & Alberto Cambrosio - 2017 - History and Philosophy of the Life Sciences 39 (2):10.
    This paper builds on previous work that investigated anticancer drugs as ‘informed materials’, i.e., substances that undergo an informational enrichment that situates them in a dense relational web of qualifications and measurements generated by clinical experiments and clinical trials. The paper analyzes the recent transformation of anticancer drugs from ‘informed’ to ‘informing material’. Briefly put: in the post-genomic era, anti-cancer drugs have become instruments for the production of new biological, pathological, and therapeutic insights into the underlying etiology and evolution of (...)
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  • What is Mechanistic Evidence, and Why Do We Need It for Evidence-Based Policy?Caterina Marchionni & Samuli Reijula - 2019 - Studies in History and Philosophy of Science Part A 73:54-63.
    It has recently been argued that successful evidence-based policy should rely on two kinds of evidence: statistical and mechanistic. The former is held to be evidence that a policy brings about the desired outcome, and the latter concerns how it does so. Although agreeing with the spirit of this proposal, we argue that the underlying conception of mechanistic evidence as evidence that is different in kind from correlational, difference-making or statistical evidence, does not correctly capture the role that information about (...)
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  • Mechanistic Evidence: Disambiguating the Russo–Williamson Thesis.Phyllis McKay Illari - 2011 - International Studies in the Philosophy of Science 25 (2):139 - 157.
    Russo and Williamson claim that establishing causal claims requires mechanistic and difference-making evidence. In this article, I will argue that Russo and Williamson's formulation of their thesis is multiply ambiguous. I will make three distinctions: mechanistic evidence as type vs object of evidence; what mechanism or mechanisms we want evidence of; and how much evidence of a mechanism we require. I will feed these more precise meanings back into the Russo?Williamson thesis and argue that it is both true and false: (...)
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  • Establishing the Teratogenicity of Zika and Evaluating Causal Criteria.Jon Williamson - forthcoming - Synthese:1-14.
    The teratogenicity of the Zika virus was considered established in 2016, and is an interesting case because three different sets of causal criteria were used to assess teratogenicity. This paper appeals to the thesis of Russo and Williamson to devise an epistemological framework that can be used to compare and evaluate sets of causal criteria. The framework can also be used to decide when enough criteria are satisfied to establish causality. Arguably, the three sets of causal criteria considered here offer (...)
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  • Causal Reasoning and Clinical Practice: Challenges From Molecular Biology.Giovanni Boniolo & Raffaella Campaner - 2019 - Topoi 38 (2):423-435.
    Not only has the philosophical debate on causation been gaining ground in the last few decades, but it has also increasingly addressed the sciences. The biomedical sciences are among the most prominent fields that have been considered, with a number of works tackling the understanding of the notion of cause, the assessment of genuinely causal relations and the use of causal knowledge in applied contexts. Far from denying the merits of the debate on causation and the major theories it comprises, (...)
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  • The Judgements That Evidence-Based Medicine Adopts.Elena Rocca - 2018 - Journal of Evaluation in Clinical Practice 24 (5):1184-1190.
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  • The Ethics of Ironic Science in Its Search for Spoof.Maryam Ronagh & Lawrence Souder - 2015 - Science and Engineering Ethics 21 (6):1537-1549.
    The goal of most scientific research published in peer-review journals is to discover and report the truth. However, the research record includes tongue-in-cheek papers written in the conventional form and style of a research paper. Although these papers were intended to be taken ironically, bibliographic database searches show that many have been subsequently cited as valid research, some in prestigious journals. We attempt to understand why so many readers cited such ironic science seriously. We draw from the literature on error (...)
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  • Robustness and Evidence of Mechanisms in Early Experimental Atherosclerosis Research.Veli-Pekka Parkkinen - 2016 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 60:44-55.
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  • The Risk GP Model: The Standard Model of Prediction in Medicine.Jonathan Fuller & Luis J. Flores - 2015 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 54:49-61.
    With the ascent of modern epidemiology in the Twentieth Century came a new standard model of prediction in public health and clinical medicine. In this article, we describe the structure of the model. The standard model uses epidemiological measures-most commonly, risk measures-to predict outcomes (prognosis) and effect sizes (treatment) in a patient population that can then be transformed into probabilities for individual patients. In the first step, a risk measure in a study population is generalized or extrapolated to a target (...)
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  • Jeremy Howick The Philosophy of Evidence‐Based Medicine.Wiley‐Blackwell & BMJ Books, 2011. Xiv + 229 Pp. ISBN 978‐1‐4051‐9667‐3 (Paperback). [REVIEW]Jesper Jerkert - 2013 - Theoria 79 (2):180-186.
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