Medical Methodology

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 (...) the probabilities reported. Patients may also require guidance on how probability claims may or may not be relevant to their decisions, and physicians should be ready to help patients understand these issues. (shrink)

There is a lot of conceptual engineering going on in medical research. I substantiate this claim with two examples, the medical debate about cancer classification and about obesity as a disease I also argue that the proper target of conceptual engineering in medical research are experts’ conceptions. These are explicitly written down in documents and guidelines, and they bear on research and policies. In the second part of the chapter, I propose an externalist framework in which conceptions have both the (...) explanatory power of psychological concepts and that of semantic concepts. It is likely, however, that human activities and practices distinct from medical research, and regulated by different practices and epistemic rules, call for different targets for conceptual engineering. I conclude with indicating an open agenda of problems for philosophers of medicine interested in conceptual engineering. (shrink)

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 (...) is an instance of a more general problem I call the underdetermination of evidential significance. Disagreements about the strength of a particular piece of evidence can be due to different—but in principle equally good—weightings of the fine-grained methodological features which constitute QATs. (shrink)

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 (...) recent work in the philosophy of medicine; the third part addresses new developments in medical research that raise interesting questions for philosophy of medicine; the fourth part is a discussion of philosophical issues within the practice of diagnosis; the fifth part focuses on the recent developments in psychiatric classification and scientific and ethical issues therein, and the final part focuses on the objectivity of medical research. (shrink)

In this article, we analyse how researchers use the categories of race and ethnicity with reference to genetics and genomics. We show that there is still considerable conceptual “messiness” (despite the wide-ranging and popular debate on the subject) when it comes to the use of ethnoracial categories in genetics and genomics that among other things makes it difficult to properly compare and interpret research using ethnoracial categories, as well as draw conclusions from them. Finally, we briefly reconstruct some of the (...) biases of reductionism to which geneticists (as well as other researchers referring to genetic methods and explanations) are particularly exposed to, and we analyse the problem in the context of the biologization of ethnoracial categories. Our work constitutes a novel, in-depth contribution to the debate about reporting race and ethnicity in biomedical and health research. First, we reconstruct the theoretical background assumptions about racial ontology which researchers implicitly presume in their studies with the aid of a sample of recent papers published in medical journals about COVID-19. Secondly, we use the typology of the biases of reductionism to the problem of biologization of ethnoracial categories with reference to genetics and genomics. (shrink)

Precision medicine and molecular systems medicine (MSM) are highly utilized and successful approaches to improve understanding, diagnosis, and treatment of many diseases from bench-to-bedside. Especially in the COVID-19 pandemic, molecular techniques and biotechnological innovation have proven to be of utmost importance for rapid developments in disease diagnostics and treatment, including DNA and RNA sequencing technology, treatment with drugs and natural products and vaccine development. The COVID-19 crisis, however, has also demonstrated the need for systemic thinking and transdisciplinarity and the limits (...) of MSM: the neglect of the bio-psycho-social systemic nature of humans and their context as the object of individual therapeutic and population-oriented interventions. COVID-19 illustrates how a medical problem requires a transdisciplinary approach in epidemiology, pathology, internal medicine, public health, environmental medicine, and socio-economic modeling. Regarding the need for conceptual integration of these different kinds of knowledge we suggest the application of general system theory (GST). This approach endorses an organism-centered view on health and disease, which according to Ludwig von Bertalanffy who was the founder of GST, we call Organismal Systems Medicine (OSM). We argue that systems science offers wider applications in the field of pathology and can contribute to an integrative systems medicine by (i) integration of evidence across functional and structural differentially scaled subsystems, (ii) conceptualization of complex multilevel systems, and (iii) suggesting mechanisms and non-linear relationships underlying the observed phenomena. We underline these points with a proposal on multi-level systems pathology including neurophysiology, endocrinology, immune system, genetics, and general metabolism. An integration of these areas is necessary to understand excess mortality rates and polypharmacological treatments. In the pandemic era this multi-level systems pathology is most important to assess potential vaccines, their effectiveness, short-, and long-time adverse effects. We further argue that these conceptual frameworks are not only valid in the COVID-19 era but also important to be integrated in a medicinal curriculum. (shrink)

This article develops a constructive criticism of methodological conventionalism. Methodological conventionalism asserts that standards of inductive risk ought to be justified in virtue of their ability to facilitate coordination in a research community. On that view, industry bias occurs when conventional methodological standards are violated to foster industry preferences. The underlying account of scientific conventionality, however, is problematically incomplete. Conventions may be justified in virtue of their coordinative functions, but often qualify for posterior empirical criticism as research advances. Accordingly, industry (...) bias does not only threaten existing conventions but may impede their empirically warranted improvement if they align with industry preferences. My empiricist account of standards of inductive risk avoids such a problem by asserting that conventional justification can be pragmatically warranted but has, in principle, only a provisional status. Methodological conventions, therefore, should not only be defended from preference-based infringements on their coordinative function but ought to be subjected to empirical criticism. (shrink)

The COVID-19 pandemic has demonstrated how different (even conflicting) interventions on nature can be scientifically justified: interventions can be deemed "effective" only in relation to specific target variables - in relation to variables the values of which we seek to control. Choosing the "right" target variables, in turn, depends on our values and pragmatic aims. This essay is based on a presentation given at the symposium "Multidisciplinary Perspectives on the COVID-19 Pandemic", organised at the Helsinki Collegium for Advanced Studies on (...) 16 June 2020. (shrink)

Brummett and Salter propose a useful and timely taxonomy of clinical ethics expertise (2019). As the field becomes further “professionalized” this taxonomy is important, and the core of it is right. It needs some refinement around the edges, however. In their conclusion, Brummett and Salter rightly point out that there is a significant difference between the ethicist whose recommendations are procedure- and process-heavy, consensus-driven, and dialogical and the authoritarian ethicist whose recommendations flow from “private moral views” (Brummett and Salter, 2019). (...) This admission doesn’t go far enough. Brummett and Salter’s taxonomy fails to capture the notion that offering recommendations whose normative force is moral is different in kind from recommendations whose normative force is non-moral, such as those recommendations that are free of moral content or justified by convention. The difference is in kind, not scale. I argue further that clinical ethics expertise, if possible, consists at least in offering recommendations whose normative force is moral. These two claims imply that the taxonomy fails to cut clinical ethics expertise at the joints: the ethicist who offers justified non-moral normative recommendations is a different kind of ethicist from the one who offers justified moral normative recommendations, yet both are categorized as clinical ethics experts. I finish by offering a refinement of the taxonomy that more precisely categorizes clinical ethicists. (shrink)

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 (...) case. We also identify three practical reasons why RCTs do not qualify as the best option for PET validation, which have to do with specific characteristics of nuclear diagnostic imaging, and of radiopharmaceuticals. The paper is meant to contribute both to the philosophical discussion on the EBM hierarchy of evidence, and on the specific debate on radiopharmaceuticals in nuclear medicine. (shrink)

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 (...) from trials is supposed to be integrated in practice. In this paper, I look at this issue from an epistemological perspective, (looking at how different types of knowledge in EBM can be used to make sounds judgements). In particular, I introduce an epistemological issue for this integration problem, which I call the epistemic integration problem. This is essentially the problem of how we can use information that is both general (eg, about a population sample) and descriptive (eg, about what expected outcomes are) to reach clinical judgements that are individualized (applying to a particular patient) and normative (about what is best for their health). (shrink)

THE IMMORTAL FLY: ETERNAL WHISPERS. WHO IS SHE? Author: Rituparna Ray Chaudhuri. Hello, Recently my book named, ‘The Immortal Fly: Eternal Whispers : Based On True Events of a Family' been published from Partridge (USA) In Association with Penguin Random House (UK) and achieved a separate Google identity. -/- As being # the author of the book, I thought to define self in the book what is definition of 'Depression'. I wanted to explain self in many ways, but the best (...) quotation appeared to me : “My life will end someday, but it will end at my convenience.’’ -/- ***** I am missing "her". By now, years passed without 'her' . Even though, unlike before, everything is becoming to be more scattered, gloomy and desolate. She is no-where whom I share my feelings. Even now, when I do close my eyes, I can visualize the same that I had left years since on 7th February, 2019 at 8.20 A.M. in the hospital struggling a continuous period of fifty days : on the fifty one day, my father said, ”The End of our Fifty Years relationship has been completed with the Fifty Days”….’Whoever’ she was to others , but she is our legend…To me, she is ‘My Ma’. -/- The story could begin, 'I failed preciously on success of my life.' Simplicity, Innocence, Belief, Faith and Personality met unknowingly with filthy waves skillfully immersed in Betray, Sorcery, Jealousy, Greediness, Revenge, Lie... ‘’ ******* The Daughter writes, “I had asked Ma many times, but her ‘impenetrable personality’ and dynamic words to everyone with a tinge of smile as reflected on her face, she was reluctant to continue her conversation with me. I had thought, hence, I must not be indefinite on my spoken words. Who shall I blame!” Based on true story of a family came from South Calcutta (India) to a suburb, on staying at home of the Daughter’s maternal grandmother’s house, this book reveals in facts and true events how Destiny had unknowingly ‘further’ played an abominable role to Fate of The Daughter, when eventually one day on 7th February, 2019 everything was finished within 8.20A.M. The Daughter is, therefore, left alone on terrestrial with immortal words as written in her Diary, ‘Eternal Whispers’: “My words to self that I am to fulfill my Ma’s - wish. ’’ ‘’ -/- • Keywords: 1. Diary and True Events 2. The Chaotic Society 3. Fatality 4. Of A-Family 5. Science , Philosophy and Literature 6. Severe Depression 7. Medical Journey. -/- The Alternative Title of the Book: The Greatest Mistake or Fortune:: The book is mainly carrying with intense words of a journey of the relationship between a Mother with her Daughter has left readers in an abrupt situation where ,perhaps, I can define "Man is the innocent creature with 'his' personality under circumstances..." -/- . (shrink)

This paper summarizes the seminar AI in Medicine in Context: Hopes? Nightmares? that was held at the Centre for Ethics at the University of Toronto on October 17, 2017, with special guest assistant professor and neurosurgeon Dr. Sunit Das. The paper discusses the key points from Dr. Das' talk. Specifically, it discusses about Dr. Das' perspective on the ethical and moral issues that was experienced from applying artificial intelligence (AI) in law and how such issues can also arise when applying (...) AI to medicine, and concludes with a brief discussion on how such issues can be prevented. (shrink)

Gegenstand dieses Beitrags ist eine Auseinandersetzung mit der Wissenschaftlichkeit der Medizin. Den Leitfaden der Analyse bildet dabei ein jüngerer Ansatz in der analytischen Wissenschaftstheorie, wonach Systematizität als zentrales Kriterium von Wissenschaft anzusehen ist (Hoyningen-Huene 2013). Ich werde im Detail zeigen, dass die Medizin dieses mehrdimensionale Kriterium insgesamt erfüllt, dass aus der Wissenschaftlichkeit der Medizin aber gleichwohl normative Konsequenzen folgen, die beispielsweise zur Abgrenzung von der Homöopathie und einer kritischen Bewertung des biopsychosozialen Modells führen. Zudem resultieren der Anwendungscharakter der Medizin und (...) die zentrale Bedeutung des Arzt-Patienten-Verhältnisses nicht in einer Schwächung des Anspruchs der Medizin als Wissenschaft. (shrink)

Part of a symposium devoted to ‘Prediction, Understanding, and Medicine’, in which Alex Broadbent argues that the nature of medicine is determined by its competences, i.e., which things it can do well. He argues that, although medicine cannot cure well, it can do a good job of enabling people not only to understand states of the human organism and of what has caused them, but also to predict future states of it. From this Broadbent concludes that medicine is (at least (...) in part) essentially a practice of understanding and predicting, not curing. In reply to this bold position, I mount two major criticisms. First, I maintain that the reasons Broadbent gives for doubting that medicine can cure provide comparable reason for doubting that medicine can provide an understanding; roughly, the best explanation of why medicine cannot reliably cure is that we still lack much understanding of health and disease. Second, I object to the claim that a practice is medical only if it facilitates understanding and prediction. Although Broadbent has brought to light certain desirable purposes of medicine that are under-appreciated, my conclusion is that he has not yet provided enough reason to think that understanding and prediction are essential to it. Instead of supposing that medicine has an essence, in fact, I suggest that its nature is best understood in terms of a property cluster. (shrink)

The first part of a symposium devoted to Alex Broadbent's essay titled ‘Prediction, Understanding and Medicine’, this article notes the under-development of a variety of issues in the philosophy of medicine that transcend bioethics and the long-standing debates about the nature of health/illness and of evidence-based medicine. It also indicates the importance of drawing on non-Western, and particularly African, traditions in addressing these largely metaphysical and epistemological matters.

Patient centred diagnosis is best practised through shared decision making; an iterative dialogue between doctor and patient, whichrespects a patient’s needs, values, preferences, and circumstances. -/- Shared decision making for diagnostic situations differs fundamentally from that for treatment decisions. This has important implications when considering its practical application. -/- The nature of dialogue should be tailored to the specific diagnostic decision; scenarios with higher stakes or uncertainty usually require more detailed conversations.

Over the past 25 years, several new “medicines” have come screeching onto health care’s various platforms, including narrative medicine, personalized medicine, precision medicine and person-centred medicine. Philosopher Miriam Solomon calls the first three of these movements different “ways of knowing” or “methods,” and argues that they are each a response to shortcomings of methods that came before them. They should also be understood as reactions to the current dominant model of medicine. In this article, I will describe our dominant model, (...) which I call “the new medical model.” I will argue that several towering problems in modern medicine can be traced to its philosophical foundations, which calls for philosophical analysis. (shrink)

En este artículo expondré un análisis de la valoración negativa de las consecuencias que suelen atribuirse al fenómeno de la medicalización y, partiendo de aquí, mi objetivo básico será mostrar que la medicalización no es en sí mismo un fenómeno negativo. Sólo lo será cuando se obtenga un valor negativo del cálculo entre, por un lado, la efectividad de la propuesta médica para solucionar el problema y, por otro lado, el balance entre los beneficios de dicha propuesta médica y sus (...) posibles efectos secundarios; o bien, cuando se dé un contexto en el que el individuo, ya sea por desinformación o por una restricción externa (paternalismo médico), no tiene la libertad suficiente de escoger entre una propuesta médica y una propuesta no-médica. (shrink)

This chapter discusses several kinds of reduction that are often found in the biomedical sciences, in contrast to reduction in fields such as physics. This includes reduction as a methodological assumption for how to investigate phenomena like complex diseases, and reduction as a conceptual tool for relating distinct models of the same phenomenon. The case of Parkinson’s disease illustrates a wide variety of ways in which reductionism is an important tool in medicine.

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 (...) to conflicting ontologies. This paper aims to make explicit some of the most fundamental assumptions that motivate EBM and PCH, respectively, in order to show that the choice between them ultimately comes down to ontological preference. While EBM has a solid foundation in positivism, or what I here call Humeanism, PCH is more consistent with causal dispositionalism. I conclude that if there is a paradigmatic revolution on the way in medicine, it is first of all one of ontology. (shrink)

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 (...) EBM against its alternatives. In this paper, I propose a set of criteria for this purpose based on Helen Longino's criteria for assessing the objectivity of a knowledge productive community. I then apply these criteria to assess EBM against a casuistic framework for medical knowledge. I argue that EBM's strict adherence to a hierarchical organization of knowledge can reasonably be expected to block it from fulfilling a high level of objectivity. A casuistic framework, on the other hand, because it emphasizes critical evaluation in conjunction with the flexibility of a case-based approach, could be expected to better facilitate a more optimal epistemic community. (shrink)

Disagreement among experts is a central topic in social epistemology. What should an expert do when confronted with the different opinion of an epistemic peer? Possible answers include the steadfast view (holding to one’s belief), the abstemious view (suspending one’s judgment), and moderate conciliatory views, which specify criteria for belief change when a peer’s different opinion is encountered. The practice of Delphi techniques in healthcare, medicine, and social sciences provides a real-life case study of expert disagreement, where disagreement is gradually (...) transformed into consensus. An analysis of Delphi shows that moderate conciliatory views are descriptively more adequate than rival views. However, it also casts doubt on whether the debate in social epistemology is explanatory relevant vis-à-vis real life cases of expert disagreement, where consensus replaces truth, and acceptance is more explanatorily relevant than belief. (shrink)

Disagreement among experts is a central topic in social epistemology. What should an expert do when confronted with the different opinion of an epistemic peer? Possible answers include the steadfast view, the abstemious view, and moderate conciliatory views, which specify criteria for belief change when a peer’s different opinion is encountered. The practice of Delphi techniques in healthcare, medicine, and social sciences provides a real-life case study of expert disagreement, where disagreement is gradually transformed into consensus. An analysis of Delphi (...) shows that moderate conciliatory views are descriptively more adequate than rival views. However, it also casts doubt on whether the debate in social epistemology is explanatory relevant vis-à-vis real life cases of expert disagreement, where consensus replaces truth, and acceptance is more explanatorily relevant than belief. (shrink)

Last year saw the 20th anniversary edition of JECP, and in the introduction to the philosophy section of that landmark edition, we posed the question: apart from ethics, what is the role of philosophy ‘at the bedside’? The purpose of this question was not to downplay the significance of ethics to clinical practice. Rather, we raised it as part of a broader argument to the effect that ethical questions – about what we should do in any given situation – are (...) embedded within whole understandings of the situation, inseparable from our beliefs about what is the case, what it is that we feel we can claim to know, as well as the meaning we ascribe to different aspects of the situation or to our perception of it. Philosophy concerns fundamental questions: it is a discipline requiring us to examine the underlying assumptions we bring with us to our thinking about practical problems. Traditional academic philosophers divide their discipline into distinct areas that typically include logic: questions about meaning, truth and validity; ontology: questions about the nature of reality, what exists; epistemology: concerning knowledge; and ethics: how we should live and practice, the nature of value. Any credible attempt to analyse clinical reasoning will require us to think carefully about these types of question and the relationships between them, as they influence our thinking about specific situations and problems. So, the answers to the question we posed, about the role of philosophy at the bedside, are numerous and diverse, and that diversity is illustrated in the contributions to this thematic edition. (shrink)

Ontology is one strategy for promoting interoperability of heterogeneous data through consistent tagging. An ontology is a controlled structured vocabulary consisting of general terms (such as “cell” or “image” or “tissue” or “microscope”) that form the basis for such tagging. These terms are designed to represent the types of entities in the domain of reality that the ontology has been devised to capture; the terms are provided with logical defi nitions thereby also supporting reasoning over the tagged data. Aim: This (...) paper provides a survey of the biomedical imaging ontologies that have been developed thus far. It outlines the challenges, particularly faced by ontologies in the fields of histopathological imaging and image analysis, and suggests a strategy for addressing these challenges in the example domain of quantitative histopathology imaging. The ultimate goal is to support the multiscale understanding of disease that comes from using interoperable ontologies to integrate imaging data with clinical and genomics data. (shrink)

To be effective, a medical intervention must improve one's health by targeting a disease. The concept of disease, though, is controversial. Among the leading accounts of disease-naturalism, normativism, hybridism, and eliminativism-I defend a version of hybridism. A hybrid account of disease holds that for a state to be a disease that state must both (i) have a constitutive causal basis and (ii) cause harm. The dual requirement of hybridism entails that a medical intervention, to be deemed effective, must target either (...) the constitutive causal basis of a disease or the harms caused by the disease (or ideally both). This provides a theoretical underpinning to the two principle aims of medical treatment: care and cure. (shrink)

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 (...) to parameters that are only indirectly relevant. Effectiveness always should be measured and reported in absolute terms (using measures such as 'absolute risk reduction'), and only sometimes should effectiveness also be measured and reported in relative terms (using measures such as 'relative risk reduction')-employment of relative measures promotes an informal fallacy akin to the base-rate fallacy, which can be exploited to exaggerate claims of effectiveness. Finally, extrapolating from research settings to clinical settings should more rigorously take into account possible ways in which the intervention in question can fail to be effective in a target population. (shrink)

This paper provides an analysis of Franz Brentano’s thesis that psychology employs a distinctive method, which sets it apart from physiology. The aim of the paper is two-fold: First, I situate Brentano’s thesis (and the broader metaphysical system that underwrites it) within the context of specific debates about the nature and status of psychology, arguing that we regard him as engaging in a form of boundary work. Second, I explore the relevance of Brentano’s considerations to more recent debates about autonomy (...) on the one hand and theoretical and/or methodological integration on the other. I argue that Brentano puts his finger on the idea that an integrated research process presupposes the existence of distinct methods and approaches, and that he highlights the philosophical challenge of accounting for such distinct methods. I suggest that Brentano’s ideas offer unconventional perspectives on current debates, in particular regarding first-person methods and the investigative process in cognitive science. (shrink)

A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. Description: The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data (...) relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. (shrink)

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 (...) hierarchies of methodology fails to lend credence to the common practice of corroboration in medicine. I argue that the strength of evidence lies in the evidence itself, and not the methodology used to obtain that evidence. Ultimately, when it comes to evaluating the effectiveness of medical interventions, it is the evidence obtained from the methodology rather than the methodology that should establish the strength of the evidence. (shrink)

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.

Statistics play a critical role in biological and clinical research. To promote logically consistent representation and classification of statistical entities, we have developed the Ontology of Biological and Clinical Statistics (OBCS). OBCS extends the Ontology of Biomedical Investigations (OBI), an OBO Foundry ontology supported by some 20 communities. Currently, OBCS contains 686 terms, including 381 classes imported from OBI and 147 classes specific to OBCS. The goal of this paper is to present OBCS for community critique and to describe a (...) number of use cases designed to illustrate its potential applications. The OBCS project and source code are available at http://obcs.googlecode.com. (shrink)

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 (...) viral infections. ‘Pure’ placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks. Results -/- We surveyed 1715 general practitioners and 783 (46%) completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting our results are generalizable. 12% (95% CI 10 to 15) of respondents used pure placebos while 97% (95% CI 96 to 98) used impure placebos at least once in their career. 1% of respondents used pure placebos, and 77% (95% CI 74 to 79) used impure placebos at least once per week. Most (66% for pure, 84% for impure) respondents stated placebos were ethical in some circumstances. Conclusion and implications -/- Placebo use is common in primary care but questions remain about their benefits, harms, costs, and whether they can be delivered ethically. Further research is required to investigate ethically acceptable and cost-effective placebo interventions. (shrink)

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) (...) for the representation of entities in the domain of disease and medical practice. Initial applications of ND will include the annotation and analysis of large data sets and patient records for Alzheimer’s disease, multiple sclerosis, and stroke. (shrink)

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 (...) view, describing how it fails to provide a representation of the healthcare domain which would enjoy the sort of clarity, coherence, rigor and completeness that is claimed on its behalf. (shrink)

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 (...) other hand, were generally understood to be acute processes, whereby single, specific and necessary causal agents acted alone to produce disease. However, during the 1960s and 1970s, a number of cancers were discovered to have an infectious aetiology. Of particular note were two—Burkitt’s lymphoma and cervical cancer—which I will discuss in detail later in this piece. Together, these discoveries led, in the short term, to a tentative aetiological reclassification of some types of cancer as infectious diseases and, in the longer term, to a full-blown reclassification of cancer as an aetiological disease branch in its own right. This process of reclassification forms the empirical basis for my concluding remarks on the influence of classification upon causation in medicine. Through this, I aim to demonstrate that conceptual change, far from being a purely abstract concern of the philosopher of science, is of substantial import to scientific practitioners. (shrink)

Editors' introduction to 3rd thematic issue on philosophy of medicine.

This short review piece is from a textbook on Medical Ethics.

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 (...) of the same evidence can reach contradictory conclusions. Meta-analysis fails to provide objective grounds for intersubjective assessments of hypotheses because numerous decisions must be made when performing a meta-analysis which allow wide latitude for subjective idiosyncrasies to influence its outcome. I end by suggesting that an older tradition of evidence in medicine—the plurality of reasoning strategies appealed to by the epidemiologist Sir Bradford Hill—is a superior strategy for assessing a large volume and diversity of evidence. (shrink)

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 (...) problem of transferability by promoting, in the repeated process of formulating public health guidelines, feedback loops of information from the implementation setting back to researchers who are defining new studies. (shrink)

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 (...) the theory to the IPAP schizophrenia algorithm results in a representation that can be used by software agents to perform monitoring and control in a referent tracking environment. (shrink)

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 have 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.

This exchange of correspondence with a critic provides helpful explanations of aspects of the paper "On Evidence, Medical and Legal" by the same authors.