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  1. Demissie Alemayehu & Joseph C. Cappelleri (2013). Revisiting Issues, Drawbacks and Opportunities with Observational Studies in Comparative Effectiveness Research. Journal of Evaluation in Clinical Practice 19 (4):579-583.
    Rationale Despite their inherently pervasive limitations, data from observational studies are increasingly relied upon by health car.
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  2. Peter Allmark (2005). Bayes and Health Care Research. Medicine, Health Care and Philosophy 7 (3):321-332.
    Bayes’ rule shows how one might rationally change one’s beliefs in the light of evidence. It is the foundation of a statistical method called Bayesianism. In health care research, Bayesianism has its advocates but the dominant statistical method is frequentism. There are at least two important philosophical differences between these methods. First, Bayesianism takes a subjectivist view of probability (i.e. that probability scores are statements of subjective belief, not objective fact) whilst frequentism takes an objectivist view. Second, Bayesianism is explicitly (...)
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  3. James A. Anderson (2006). The Ethics and Science of Placebo-Controlled Trials: Assay Sensitivity and the Duhem-Quine Thesis. Journal of Medicine and Philosophy 31 (1):65 – 81.
    The principle of clinical equipoise requires that, aside from certain exceptional cases, second generation treatments ought to be tested against standard therapy. In violation of this principle, placebo-controlled trials (PCTs) continue to be used extensively in the development and licensure of second-generation treatments. This practice is typically justified by appeal to methodological arguments that purport to demonstrate that active-controlled trials (ACTs) are methodologically flawed. Foremost among these arguments is the so called assay sensitivity argument. In this paper, I take a (...)
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  4. D. R. Appleton (1995). Detecting Poor Design, Erroneous Analysis and Misinterpretation of Studies. Journal of Evaluation in Clinical Practice 1 (2):113-117.
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  5. William J. Appleyard (2011). A Personal Approach to Person‐Centred Paediatric Care. Journal of Evaluation in Clinical Practice 17 (2):376-378.
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  6. Sean M. Bagshaw & Rinaldo Bellomo (2008). The Need to Reform Our Assessment of Evidence From Clinical Trials: A Commentary. Philosophy, Ethics, and Humanities in Medicine 3 (1):23.
    The ideology of evidence-base medicine (EBM) has dramatically altered the way we think, conceptualize, philosophize and practice medicine. One of its major pillars is the appraisal and classification of evidence. Although important and beneficial, this process currently lacks detail and is in need of reform. In particular, it largely focuses on three key dimensions (design, [type I] alpha error and beta [type II] error) to grade the quality of evidence and often omits other crucial aspects of evidence such as biological (...)
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  7. Robyn Bluhm (2010). The Epistemology and Ethics of Chronic Disease Research: Further Lessons From Ecmo. Theoretical Medicine and Bioethics 31 (2):107-122.
    Robert Truog describes the controversial randomized controlled trials (RCTs) of extracorporeal membrane oxygenation (ECMO) therapy in newborns. Because early results with ECMO indicated that it might be a great advance, saving many lives, Truog argues that ECMO should not have been tested using RCTs, but that a long-term, large-scale observational study of actual clinical practice should have been conducted instead. Central to Truog’s argument, however, is the idea that ECMO is an unusual case. Thus, it is an open question whether (...)
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  8. Werner Ceusters & Barry Smith (2006). Referent Tracking for Treatment Optimisation in Schizophrenic Patients. Journal of Web Semantics 4 (3):229-236.
    The IPAP Schizophrenia Algorithm was originally designed in the form of a flow chart to help physicians optimise the treatment of schizophrenic patients. We examined the current version from the perspective of recent work on terminologies and ontologies thereby drawing on the resources of Basic Formal Ontology, and this with the objective to make the algorithm appropriate for Semantic Web applications. We found that Basic Formal Ontology is a rich enough theory to represent all the entities involved and that applying (...)
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  9. Brendan Clarke (2012). Causation in Medicine. In Wenceslao J. Gonzalez (ed.), Conceptual Revolutions: from Cognitive Science to Medicine. Netbiblo.
    In this paper, I offer one example of conceptual change. Specifically, I contend that the discovery that viruses could cause cancer represents an excellent example of branch jumping, one of Thagard’s nine forms of conceptual change. Prior to about 1960, cancer was generally regarded as a degenerative, chronic, non-infectious disease. Cancer causation was therefore usually held to be a gradual process of accumulating cellular damage, caused by relatively non-specific component causes, acting over long periods of time. Viral infections, on the (...)
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  10. David Colquhoun (2011). In Praise of Randomisation : The Importance of Causality in Medicine and its Subversion by Philosophers of Science. In Philip Dawid, William Twining & Mimi Vasilaki (eds.), Evidence, Inference and Enquiry. Oup/British Academy.
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  11. Galen (2011). Method of Medicine. Loeb Classical Library.
    Method of Medicine, a systematic and comprehensive account of the principles of treating injury and disease and one of Galen's greatest and most influential works.
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  12. Donald Gillies & Aidan Sudbury (2013). Should Causal Models Always Be Markovian? The Case of Multi-Causal Forks in Medicine. European Journal for Philosophy of Science 3 (3):275-308.
    The development of causal modelling since the 1950s has been accompanied by a number of controversies, the most striking of which concerns the Markov condition. Reichenbach's conjunctive forks did satisfy the Markov condition, while Salmon's interactive forks did not. Subsequently some experts in the field have argued that adequate causal models should always satisfy the Markov condition, while others have claimed that non-Markovian causal models are needed in some cases. This paper argues for the second position by considering the multi-causal (...)
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  13. Spencer Phillips Hey (forthcoming). Theory Testing and Implication in Clinical Trials. Philosophy of Science 2014.
    John Worrall (2010) and Nancy Cartwright (2011) argue that randomized controlled trials (RCTs) are "testing the wrong theory." RCTs are designed to test inferences about the causal relationships in the study population, but this does not guarantee a justified inference about the causal relationships in the more diverse population in clinical practice. In this essay, I argue that the epistemology of theory testing in trials is more complicated than either Worrall's or Cartwright's accounts suggest. I illustrate this more complex theoretical (...)
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  14. Spencer Phillips Hey (2014). Ethics and Epistemology of Accurate Prediction in Clinical Research. Journal of Medical Ethics 10:1-4.
    All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with (...)
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  15. Spencer Phillips Hey & Jonathan Kimmelman (2014). The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials. Kennedy Institute of Ethics Journal 24 (2):121-139.
    Should first-in-human trials be designed to maximize the prospect of therapeutic benefit for volunteers, prioritize avoidance of unintended harms, or aim for some happy medium between the two? Perennial controversies surrounding initiation and design of early-phase trials hinge on how this question is resolved. In this paper, we build on the premise that the task of early-phase testing is to optimize various components of a potential therapy so that later, confirmatory trials have the maximal probability of informing drug development and (...)
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  16. Spencer Phillips Hey & Charles Weijer (2013). Assay Sensitivity and the Epistemic Contexts of Clinical Trials. Perspectives in Biology and Medicine 56 (1):1-17.
    In February 2010, the World Medical Association hosted an international symposium on the ethics of placebo controls in clinical trials (WMA 2010). Despite years of debate, ethicists, clinical trialists, and policy makers remain divided over the ethical acceptability of using placebos in research when a proven, effective treatment is available. The protracted nature of this problem is due, at least in part, to a perceived conflict between the opposing demands placed on clinical research by science and ethics. A good, scientifically (...)
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  17. Joachim Hornung (1980). Carnap's Inductive Probabilities as a Contribution to Decision Theory. Theoretical Medicine and Bioethics 1 (3):325-367.
    Common probability theories only allow the deduction of probabilities by using previously known or presupposed probabilities. They do not, however, allow the derivation of probabilities from observed data alone. The question thus arises as to how probabilities in the empirical sciences, especially in medicine, may be arrived at. Carnap hoped to be able to answer this question byhis theory of inductive probabilities. In the first four sections of the present paper the above mentioned problem is discussed in general. After a (...)
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  18. Jeremy Howick (2013). Placebo Use in the United Kingdom: Results From a National Survey of Primary Care Practitioners. PLoS 8 (3).
    Objectives -/- Surveys in various countries suggest 17% to 80% of doctors prescribe ‘placebos’ in routine practice, but prevalence of placebo use in UK primary care is unknown. Methods -/- We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into ‘pure’ and ‘impure’. ‘Impure’ placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for suspected (...)
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  19. Mark Jensen, Alexander P. Cox, Naveed Chaudhry, Marcus Ng, Donat Sule Ray, William Duncan, Patrick, Bianca Weinstock-Guttman, Barry Smith, Alan Ruttenberg, Kinga Szigeti & Alexander D. Diehl (2013). The Neurological Disease Ontology. Journal of Biomedical Semantics 4 (42).
    We are developing the Neurological Disease Ontology (ND) to provide a framework to enable representation of aspects of neurological diseases that are relevant to their treatment and study. ND is a representational tool that addresses the need for unambiguous annotation, storage, and retrieval of data associated with the treatment and study of neurological diseases. ND is being developed in compliance with the Open Biomedical Ontology Foundry principles and builds upon the paradigm established by the Ontology for General Medical Science (OGMS) (...)
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  20. Joseph B. Kadane (1986). Progress Toward a More Ethical Method for Clinical Trials. Journal of Medicine and Philosophy 11 (4):385-404.
    Methodology for conducting clinical trials of new drugs and treatments on people need not be regarded as fixed. After reviewing the currently most popular method (randomization) and its ethical problems, this paper explores the possibilities of a new method for conducting such trials. It relies on new Bayesian technology for eliciting the opinions of medical experts. These opinions are conditioned on specific predictor variables, and are held in a computer. At any stage in a trial, these opinions can be updated (...)
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  21. Ian James Kidd (2013). A Pluralist Challenge to 'Integrative Medicine': Feyerabend and Popper on the Cognitive Value of Alternative Medicine. Studies in History and Philosophy of Biological and Biomedical Sciences 44 (3):392–400.
    This paper is a critique of ‘integrative medicine’ as an ideal of medical progress on the grounds that it fails to realise the cognitive value of alternative medicine. After a brief account of the cognitive value of alternative medicine, I outline the form of ‘integrative medicine’ defended by the late Stephen Straus, former director of the US National Centre for Complementary and Alternative Medicine. Straus’ account is then considered in the light of Zuzana Parusnikova’s recent criticism of ‘integrative medicine’ and (...)
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  22. Richard Moskowitz (2010). Diagnosis. Medicine Studies 2 (2):121-137.
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  23. Cecilia Nardini & Jan Sprenger (2014). Bias and Conditioning in Sequential Medical Trials. Philosophy of Science 80 (5):1053-1064.
    Randomized controlled trials are currently the gold standard within evidence-based medicine. Usually they are monitored for early signs of effectiveness or harm. However, evidence from trials stopped early is often charged with bias toward implausibly large effects. To our mind, this skeptical attitude is unfounded and caused by the failure to perform appropriate conditioning in the statistical analysis of the evidence. We contend that conditional hypothesis tests give a superior appreciation of the obtained evidence and significantly improve the practice of (...)
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  24. C. R. Palmer (1993). Ethics and Statistical Methodology in Clinical Trials. Journal of Medical Ethics 19 (4):219-222.
    Statisticians in medicine can disagree on appropriate methodology applicable to the design and analysis of clinical trials. So called Bayesians and frequentists both claim ethical superiority. This paper, by defining and then linking together various dichotomies, argues there is a place for both statistical camps. The choice between them depends on the phase of clinical trial, disease prevalence and severity, but supremely on the ethics underlying the particular trial. There is always a tension present between physicians primarily obligated to their (...)
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  25. David Pearce, The End of Suffering.
    Before anaesthesia, surgery used to be agony. It’s hard to imagine that anyone could have been anything but pleased when painless surgery was introduced in the mid-19th century. And yet, although many welcomed anaesthesia, some did object. In Zurich, anaesthesia was even outlawed. “Pain is a natural and intended curse of the primal sin. Any attempt to do away with it must be wrong,” claimed the Zurich City Fathers. Painless delivery in childbirth was a particularly contentious issue. Some insisted that (...)
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  26. Kazem Sadegh-Zadeh (1980). Bayesian Diagnostics: A Bibliography Part. Theoretical Medicine and Bioethics 1 (1):107-124.
  27. Kenneth F. Schaffner (1992). Theory Change in Immunology Part I: Extended Theories and Scientific Progress. Theoretical Medicine and Bioethics 13 (2).
    This two-part article examines the competition between the clonal selection theory and the instructive theory of the immune response from 1957–1967. In Part I the concept of a temporally extended theory is introduced, which requires attention to the hitherto largely ignored issue of theory individuation. Factors which influence the acceptability of such an extended theory at different temporal points are also embedded in a Bayesian framework, which is shown to provide a rational account of belief change in science. In Part (...)
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  28. Kenneth F. Schaffner (1992). Theory Change in Immunology Part II: The Clonal Selection Theory. Theoretical Medicine and Bioethics 13 (2).
    This two-part article examines the competition between the clonal selection theory and the instructive theory of the immune response from 1957–1967. In Part I the concept of a temporally extended theory is introduced, which requires attention to the hitherto largely ignored issue of theory individuation. Factors which influence the acceptability of such an extended theory at different temporal points are also embedded in a Bayesian framework, which is shown to provide a rational account of belief change in science. In Part (...)
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  29. David Shaw (2012). The Swiss Report on Homeopathy: A Case Study of Research Misconduct. Swiss Medical Weekly 142:w13594.
    In 2011 the Swiss government published a report on homeopathy. This report was commissioned following a 2009 referendum in which Swiss people decided that homeopathy and other alternative therapies should be covered by private medical insurance; before implementing this decision, the government wanted to establish whether homeopathy actually works. In February 2012 the report was published in English and was immediately proclaimed by proponents of homeopathy to be conclusive proof that homeopathy is effective. This paper analyses the report and concludes (...)
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  30. Barry Smith (2013). Human Action in the Healthcare Domain: A Critical Analysis of HL7’s Reference Information Model. In Johanssonian Investigations. Essays in Honour of Ingvar Johansson on His Seventieth Birthday. Ontos Verlag.
    If we are to develop efficient, reliable and secure means for sharing information across healthcare systems and organizations, then a careful analysis of human actions will be needed. To address this need, the HL7 organization has proposed its Reference Information Model (RIM), which is designed to provide a comprehensive representation of the entire domain of healthcare centered around the phenomenon of human action. Taking the Basic Formal Ontology as our starting point, we examine the RIM from an ontological point of (...)
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  31. Barry Smith, Michael Ashburner, Cornelius Rosse, Jonathan Bard, William Bug, Werner Ceusters, Louis J. Goldberg, Karen Eilbeck, Amelia Ireland, Mungall Christopher J., Neocles Leontis & Others (2007). The OBO Foundry: Coordinated Evolution of Ontologies to Support Biomedical Data Integration. Nature Biotechnology 25 (11):1251-1255.
    The value of any kind of data is greatly enhanced when it exists in a form that allows it to be integrated with other data. One approach to integration is through the annotation of multiple bodies of data using common controlled vocabularies or ‘ontologies’. Unfortunately, the very success of this approach has led to a proliferation of ontologies which itself creates obstacles to integration. The Open Biomedical Ontologies (OBO) consortium has set in train a strategy to overcome this problem. Existing (...)
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  32. Barry Smith & Werner Ceusters (2006). HL7 RIM: An Incoherent Standard. Studies in Health Technology and Informatics 124:133–138.
    The Health Level 7 Reference Information Model (HL7 RIM) is lauded by its authors as ‘the foundation of healthcare interoperability’. Yet even after some 10 years of development work, the RIM is still subject to a variety of logical and ontological flaws, which has placed severe obstacles in the way of those who are called upon to develop implementations. We offer evidence that these obstacles are insurmountable and that the time has come to abandon an unworkable paradigm.
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  33. Jacek Spławiński, Jerzy Kuźniar, Krzysztof Filipiak & Waldemar Zieliński (2006). Evaluation of Drug Toxicity in Clinical Trials. Science and Engineering Ethics 12 (1):139-145.
    An increasing number of drugs removed from the market because of unacceptable toxicity raises concerns regarding preapproval testing of drug safety. In the present paper it is postulated that the non-inferiority type of trial should be abandoned in favor of the superiority trial with active controls and less stringent (p<0.1, both for efficacy and toxicity) statistics. This approach will increase sensitivity of detection of drug-induced adverse effects at the expense of increasing false positive results regarding the difference in efficacy between (...)
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  34. Roger Stanev (2012). Modelling and Simulating Early Stopping of RCTs: A Case Study of Early Stop Due to Harm. Journal of Experimental and Theoretical Artificial Intelligence 24 (4):513-526.
    Despite efforts from regulatory agencies (e.g. NIH, FDA), recent systematic reviews of randomised controlled trials (RCTs) show that top medical journals continue to publish trials without requiring authors to report details for readers to evaluate early stopping decisions carefully. This article presents a systematic way of modelling and simulating interim monitoring decisions of RCTs. By taking an approach that is both general and rigorous, the proposed framework models and evaluates early stopping decisions of RCTs based on a clear and consistent (...)
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  35. Jacob Stegenga (forthcoming). Herding QATs: Quality Assessment Tools for Evidence in Medicine. In Huneman, Silberstein & Lambert (eds.), Herding QATs: Quality Assessment Tools for Evidence in Medicine.
    Medical scientists employ ‘quality assessment tools’ (QATs) to measure the quality of evidence from clinical studies, especially randomized controlled trials (RCTs). These tools are designed to take into account various methodological details of clinical studies, including randomization, blinding, and other features of studies deemed relevant to minimizing bias and error. There are now dozens available. The various QATs on offer differ widely from each other, and second-order empirical studies show that QATs have low inter-rater reliability and low inter-tool reliability. This (...)
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  36. Jacob Stegenga (2011). Is Meta-Analysis the Platinum Standard of Evidence? Studies in History and Philosophy of Science Part C 42 (4):497-507.
    An astonishing volume and diversity of evidence is available for many hypotheses in the biomedical and social sciences. Some of this evidence—usually from randomized controlled trials (RCTs)—is amalgamated by meta-analysis. Despite the ongoing debate regarding whether or not RCTs are the ‘gold-standard’ of evidence, it is usually meta-analysis which is considered the best source of evidence: meta-analysis is thought by many to be the platinum standard of evidence. However, I argue that meta-analysis falls far short of that standard. Different meta-analyses (...)
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  37. Christopher Lee Stephens (2011). A Bayesian Approach to Absent Evidence Reasoning. Informal Logic 31 (1).
    Normal 0 0 1 85 487 UBC 4 1 598 11.773 0 0 0 Under what conditions is the failure to have evidence that p evidence that p is false? Absent evidence reasoning is common in many sciences, including astronomy, archeology, biology and medicine. An often-repeated epistemological motto is that “the absence of evidence is not evidence of absence.” Analysis of absent evidence reasoning usually takes place in a deductive or frequentist hypothesis-testing framework. Instead, I develop a Bayesian analysis of (...)
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  38. Paul Thagard, 4 What is a Medical Theory?
    Modern medicine has produced many successful theories concerning the causes of diseases. For example, we know that tuberculosis is caused by the bacterium Mycobacterium tuberculosis, and that scurvy is caused by a deficiency of vitamin C. This chapter discusses the nature of medical theories from the perspective of the philosophy, history, and psychology of science. I will review prominent philosophical accounts of what constitutes a scientific theory, and develop a new account of medical theories as representations of mechanisms that explain (...)
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  39. Paul Thagard (2003). Pathways to Biomedical Discovery. Philosophy of Science 70 (2):235-254.
    A biochemical pathway is a sequence of chemical reactions in a biological organism. Such pathways specify mechanisms that explain how cells carry out their major functions by means of molecules and reactions that produce regular changes. Many diseases can be explained by defects in pathways, and new treatments often involve finding drugs that correct those defects. This paper presents explanation schemas and treatment strategies that characterize how thinking about pathways contributes to biomedical discovery. It discusses the significance of pathways for (...)
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  40. D. Tulodziecki (2012). Principles of Reasoning in Historical Epidemiology. Journal of Evaluation in Clinical Practice 18 (5):968-973.
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  41. Caroline Whitbeck (1981). What is Diagnosis? Some Critical Reflections. Theoretical Medicine and Bioethics 2 (3):319-329.
    It is argued that the common definition of diagnosis as the determination of the nature of a disease is misleading. Many diagnoses are not the names of disease entities. This finding reflects the integral relation of the diagnostic task to the rest of clinical reasoning. Diagnosis has no separate goal of its own, in particular it does not have the goal of determining the nature of a disease. Instead, diagnosis contributes to the general goals of clinical medicine. Any attempt to (...)
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