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14 results New Directions in the Philosophy of Science. French, S. (Ed) . Epidemiology is one of the fastest growing and increasingly important sciences.
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The second aspect of the epistemological turn in philosophy of medicine involves articulating the intersection between social, ethical, and methodologi- cal aspects of medical research.

Philosophy of Epidemiology | American Journal of Epidemiology | Oxford Academic

An example of such a concern of present and future work in philosophy of medicine is to articulate the methodological and social conditions under which many of the problems of medical research are possible. For example Jukola, ; see also the end of this chapter , argues that a compelling way to understand the shortcomings of meta-analysis requires not just an examination of the methodological details of meta-analysis, but also an examination of the social context in which this technique is employed.

As another example, De Melo-Martin and Intemann argue for a feminist approach to understanding problems with contemporary biomedical research. In a widely discussed paper, Douglas argues for the central role of values in scientific reasoning, and this thesis is especially prominent in medical research. Contributors to this literature include prominent physicians, epidemiologists, and journalists. Stegenga forth- coming , for example, argues that medical nihilism is a compelling thesis for much of recent medicine. Medical nihilism is motivated, in part, by noting problems with the socio- political nexus in which medical research takes place.

A fourth set of concerns for present and future philosophy of medicine in the epistemological turn is to address questions such as: How should medical research be modulated given the recent work on epistemology of such research? Who should pay for medi- cal research? What kinds of projects should be prioritized by funders of medi- cal research? Should the results and products of medical research be protected by intellectual property laws?

As an example of recent work in this domain, Brown argues that medical research should be socialized and the results of medical research should not be protected by patent laws. A broadly similar proposal is suggested by Reiss The epistemological turn has uncovered numerous epistemological problems with contemporary medical research, and such problems call for normative guidance. In what follows, we discuss some of these elements of the epistemological turn in the philosophy of medicine in more detail, including issues related to evidence hierarchies, extrapolation, diagnosis, the construction of psychiatric categories, and the pursuit of objectivity in medical research.

Beyond RCTs and Meta-analyses In addition to these recent developments in philosophy of medicine, there are a number of developments in medical research itself that should be of interest to philosophers. As noted earlier, much of the work being done on philosophi- cal questions raised by clinical research has examined RCTs. The rationale behind the hierarchy of evidence is that designs higher on the hierarchy have greater internal validity and more precision in their estimates of outcomes than those lower on the hierarchy.

References

Yet, as critics of EBM have pointed out, this precision may come at the cost of generalizability. First, because many RCTs have strict inclusion and exclu- sion criteria, many of the patients who might be treated with a drug in clinical practice would not have qualified for participation in the trial that tested that drug.

Meta-analyses exacerbate this problem, since they usually average the average results across studies to get a more precise estimate of outcomes. This section surveys several of these trends and outlines their potential interest for philosophers of medicine. To achieve this, explanatory studies have strict inclusion and exclusion criteria; for example, limiting eligibility to a narrow age range and enrolling only patients with no comorbid conditions, who are not taking concomitant medications.

It is therefore not clear how well causal relationships between treatment and outcome observed in sub- jects enrolled in explanatory studies might hold up in other kinds of patients. Because of this, greater attention is now being paid to research that is more closely integrated with clinical practice.

Learning healthcare systems would conduct a variety of kinds of research, including long-term observational studies and studies using administrative databases and patient records. Pragmatic trials, for example, tend to enroll a broader range of patients than explanatory trials, as well as to involve physicians working in a wider variety of care settings. They may also, unlike explanatory trials, allow variability in treatment protocol. While some studies that take a more pragmatic approach to research design are RCTs, others may examine outcomes in the context of actual clinical prac- tice, for example, examining patient records or using nonrandomized designs to follow patients who receive an intervention of interest.

This spectrum of research designs raises interesting epistemological and eth- ical questions for philosophers of medicine. For example, work in research eth- ics has traditionally taken it to be the case that a sharp distinction can be made between research and clinical practice, but this can no longer be assumed. For example, according to Thorpe et al. We briefly survey three of these developments here: While these examples are not concerned directly with treatment outcomes, they do aim ultimately to improve health interventions by ensuring that they target only groups of patients in which there is a higher-than-average chance of benefit.

In , Rebecca Dresser pointed out that medical research was conducted almost entirely on white men, and she argued that the near exclusion of other demographic groups was both ethically and epistemologi- cally problematic. Another attempt to develop more clinically useful groupings of patients comes from oncology research. These patients were found to have similar mutations, suggesting that new treatments may target specific genetic markers Lynch et al. For example, vemurfenib has been approved for treatment of melanoma, in which a mutation called BRAF VE is fairly common.

This work sug- gests that understanding the relationship between tumor type and mutation type may be important.

New Directions in the Philosophy of Science

Although advocates believe that basket trials have the promise to revolutionize cancer treatment, it should be noted that the available evidence is still very scant. The most radical attempt to find new ways of grouping patients is the RDoC project, which aims to replace current, symptom-based diagnostic categories— and, by extension, prognostic and treatment categories—with new diagnostic groups that are rooted in genetics, behavioral sciences, and, especially, neuro- science.

The columns of the matrix reflect units or levels of analysis e. Similarly, using constructs as the basic categorization may entail that among patients with the same diagnosis, only some will be eligible for a study that examines a particular construct. The NIMH notes that the RDoC project is still in its preliminary stages, and very much open to revision including the possible addition of new con- structs. It also notes that the true test of the framework as a whole and of particular constructs is their clinical usefulness: At the same time, it is clear that the NIMH is betting that the biological approach is the best way to achieve progress in psychiatry and to overcome the limitations of the current symptom-based approach.

Initiatives like RDoC, basket trials, and gender medicine raise philosophi- cally interesting questions about the establishment of prognostic and, par- ticularly in the case of RDoC, of diagnostic groups.


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Diagnosis Compared with discussions of clinical research on treatments, which has also been the primary focus of the previous sections of this chapter, there is less philosophical work on diagnosis. This represents a significant research gap, as diagnosis is of pivotal importance in medical practice, and as such is the start- ing point of the clinical encounter. Before treatment or prognostic evaluation of a patient can begin, there must be at least a working diagnosis.

If a clinician does not begin the clinical encounter by working to obtain an accurate diag- nosis, then subsequent treatments prescribed for the patient are likely to fail, and prognoses to be inaccurate. In light of the important role of diagnosis in medical practice, it might seem somewhat surprising that the philosophy of medicine literature on diagnosis is sparse.

A recent survey, for example, found that of the articles published over a year span in the two main philos- ophy of medicine journals, Journal of Medicine and Philosophy and Theoretical Medicine and Bioethics, only 4 included a discussion of diagnosis Stempsey, Addressing this research gap is another new area in which philosophers of medicine are beginning to work.

There are many issues in diagnosis and diagnostics that have as yet to benefit from philosophical attention. In the next section, we note a few of them and then examine one in detail: Philosophical Questions in Diagnostic Practice Philosophical questions in diagnostic practice can be roughly divided between those that concern diagnostic reasoning and those that concern diagnostics tests and procedures that are used in the process of medical diagnosis.

In the first category, there are questions of whether there is a logic of diagnosis, and if so, whether this logic is computable, and whether the diagnostic reasoning process is generalizable.


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In the second category, which we examine more closely here, the questions concern the diagnostic tests and procedures themselves, and how they should be evaluated. In the first instance, diagnostic tests need to be evaluated for accuracy. However, even once a diagnostic test is determined to be relatively accurate, the question of whether it is valuable remains. Thus the process of determining the medical worth of a diag- nostic test has both epistemic and ethical components. Diagnostic Accuracy and Patient Outcomes Before we can determine whether a diagnostic test is valuable, we must first determine whether the test is accurate.

Currently, there is discussion in the medical literature3 about the best way to determine diagnostic accuracy. However, RCTs are now being used, for example, to determine whether one diagnostic test is more accurate i. This can be done, for instance, to test the comparative accuracy of a new, or lesser used, diagnostic test against the currently accepted clinical reference standard the test that is deemed to be the most reliable available test for diagnosing a given condition. As the sensitivity and specificity of diagnostic tests such as these can vary across population subgroups, the two tests must be evaluated in comparable groups, one of which is randomized to receive the older test, and the other of which is randomized to receive the newer test.

Or, the trial could be designed so that the same group receives both tests Bossuyt et al. Even when a diagnostic is accurate, this does not guarantee that it might improve patient outcomes.

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Thus while the result accurate or inaccurate of a diagnostic test might in turn lead to a decision that has an impact on the patient, the information generated by the test alone does not have this power. Some have argued that, because of this, we ought not only to be concerned with determining test accuracy, but also with finding out whether performing a test ultimately improves the lives of patients. In order to determine this, we need to know whether a given diagnostic test is a good predictor, not only of the condition it is intended to diagnose, but also of treatment outcomes for this con- dition.

However, just how to design a trial that reliably provides this infor- mation is not immediately straightforward. Thus, a trial of the impact of a diagnostic test on patient outcomes is really a trial of the test plus treatment and perhaps also of cost, impact of the informa- tion gained on the patient, etc. One central concern in designing these trials is the decision of when or where to randomize. For example, one might ask whether an accurate diagnostic test for an untreatable disease has any medical worth. While it has been established that many patients do want to know what is wrong with them, even when a treatment for their illness or condition is not available, clinicians are divided over whether an accurate test for an untreatable disease should ever be performed Lijmer and Bossuyt, To resolve this issue depends upon how we understand value in the medical context—for example, whether we believe that value is tied inextricably to patient outcomes or whether we believe that a test that provides knowledge is valuable even when it does not lead to improved patient health.

The argument is that patients undergoing a diagnostic test for arterial stenosis, for example, are not interested simply in knowing whether they have the condition, but in whether treating the condition might prevent a cerebrovascular episode. The above issue cannot be addressed solely by an analysis of diagnostic accuracy.

The test can be given to a healthy person with a family history of the disease and then allows the person to know whether he or she will develop the disease in the future. On the other hand, one could argue that since medicine is an applied practice that aims at improving patient health, and that, further, operates under limited resources, it would be a waste of both time and monetary resources to perform a test that will not in any way improve the health outcome of the patient.

Philosophy of Epidemiology

In summary, diagnostic reasoning and testing is a new area of research within the field of philosophy of medicine, and the questions to be analyzed in this area are both varied and complex, in many cases containing both epistemic and ethical, as well as theoretical and applied, components. New Directions in Philosophy of Psychiatry In contrast to other areas of philosophy of medicine, questions about diagnosis have been of central concern in the philosophy of psychiatry. More generally, the relationship between philosophy of psychiatry and philosophy of medi- cine is not as close as it perhaps should be.

We believe that there could be a productive exchange of ideas between philosophy of psychiatry and philosophy of medicine; however, this discussion is beyond the scope of the chapter. Here, we will focus on ques- tions relevant to psychiatric diagnosis. Mental illness is an urgent and growing public health problem, contribut- ing to the global burden of disease throughout the world. Vast deficiencies in mental healthcare across the globe are matched by ongoing controversy over the nature, causes, and best treatments for disorders such as schizophrenia and depression. The goal of this section is to outline the issues concerning the scientific and ethical issues surrounding the psychiatric classification systems, as they have become the focus of increased controversy leading to and following the pub- lication of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders DSM-5 American Psychiatric Association, It is designed for pragmatic use across a variety of settings to accomplish a plethora of tasks: One core concern that stems from the multiplicity of the purposes assigned to the DSM-5 is its questionable capac- ity in fully fulfilling these roles.

This concern, which is getting stronger fol- lowing the publication of the DSM-5, focuses on its usefulness in the clinical context during the diagnosis and treatment of mental disorders, and utility for advancing research on the etiology of mental disorders. With respect to clinical use, we highlight the problems associated with its symptom-based approach to classifying mental disorders. For instance, this feature has led to the removal of the bereavement exclusion criterion from the major depression category, allow- ing complicated grief to be diagnosed as depression on the grounds that grief related distress and depression are manifest through the same symptoms.

We then turn to research related limitations of the DSM These earlier approaches relied on empirically undefended theoretical assumptions about the workings of the mind, rather than outwardly observable disease correlates. In the DSM-III, a descriptive approach replaced this framework because clusters of symptoms and signs, by virtue of their observability and measura- bility, were thought to facilitate objective scientific research and reliable clinical diagnosis. A scientifically valid category of mental disorder requires external validators, such as symptoms and signs, not simply theories Robins and Guze, Thus, symptom and sign clusters were resourceful constructs for scien- tists whose goal was to investigate better the neurological and genetic under- pinnings of mental illness.

The proponents of the descriptive approach have first come up with a broad list of signs and symptoms individuating mental disorders, knowing that these are only abstractions and that they do not cap- ture the full complexity of mental disorders. The hope was that as psychiatry progressed symptoms and signs would be better delineated and more refined categories might be developed.

However, this did not happen; rather the char- acterization of mental disorders as symptom clusters remained. The categories have departed further from the complex and real experiences of individuals with mental disorders. One significant disadvantage of operationalizing a symptom-based approach is that the symptom clusters fail to represent certain complexities involved in mental disorder, which are neither immediately observable nor readily measur- able.

DSM-5 categories, by virtue of highlighting symptoms, abstract or bracket the self-related and context- specific aspects with mental disorders. The argu- ment for this change is as follows: The DSM-5 has also not satisfied those interested in developing a psychiatric taxonomy system that advances research in psychiatry.

RDoC brings together the resources provided by various basic sci- ences, including genetics and neuroscience. Instead of organizing psychopathology into DSM-5 categories like schizophrenia and major depressive disorder, the RDoC explicates psychopathology in terms of basic psychological processes e. Insel provides three fundamental tenets of the RDoC. First, RDoC is a diagnostic approach based on biology, not on observable signs and symptoms. Second, it takes mental disorders to be biological disorders involving brain cir- cuitry that implicate the specific domains of cognition, emotion, or behavior.

It is expected that scientists can better identify and investigate the circuits impli- cated in mental illness as neuroscience and genetics advance. Third, the map- ping of the cognitive, circuit, and genetic aspects of mental disorders can yield new and better targets for treatment. Some critics have suggested that the primacy of neuroscientific and genetic research in psycho- pathology continues an unfortunate trend that ignores the crucial role of the phenomenology of mental illness, and this may have negative implications for treatment Graham and Flanagan, Finally, some critics worry that the developers of the RDoC are making the same mistake as those who were instru- mental in developing the symptom-based criteria for mental disorders.

As dis- cussed earlier, the proponents of the descriptive approach characterized mental disorders through a list of signs and symptoms, knowing that these are only abstractions and that they do not capture the full complexity of mental disor- ders. However, as the DSM project evolved, they dropped the recognition that such characterizations are abstractions, leaving the categories of mental disor- ders further away from the true complexities of mental disorders.

Objectivity and Medical Research A final area that we want to highlight as an important new direction in philoso- phy of medicine is that of the objectivity of medical research. The social context of medical research, in part, helps to constitute the objectivity of medical research and, in part, serves to threaten that very objectivity. As a discipline whose results often bear direct social relevance, medical research attracts considerable interest among the general public. For instance, 58 percent of Americans say they are interested in new medical discoveries National Science Foundation, and, according to the Welcome trust moni- tor report , 75 percent of adults in the United Kingdom reported being curious about medical research.

Media reports on new cures, clinical guide- lines, and possible health threats may influence the behavior of the members of the public. Scandals such as the ones related to the link between the painkiller Vioxx and cardiovascular events Biddle, and selective serotonin reup- take inhibitors and suicidal ideation Healy, have raised doubts about the trustworthiness of medical research and the integrity of scientists working in the field. Similarly, the recent outbreaks of vaccine-preventable diseases—such as measles, whooping cough, and polio—have been associated with the rise of the antivaccine movement and the distrust of established medical expertise Poland and Jacobson, One of the conditions for maintaining trust in science is that research is conducted in a way that is thought to be objective.

Thus, searching for the means that best support objectivity is a central assignment for medical scientists and philosophers of medicine. Commercial interests have been associated with many of the scandals that have threatened the apparent trustworthiness of medical science, since industry-funded drug trials report favorable results for company products when compared to trials funded by independent agencies Lundh et al.

Epidemiology at the Interface of Science, Policy, and Politics

Furthermore, reports of secrecy and dubious practices in medical research, par- ticularly in the development of new drugs, have started to emerge Sismondo, Biomedical research is a highly commercialized field. In , 58 percent of research in the United States was funded by private sources Moses et al. Consequently, critics have argued that the objectivity of the discipline is being compromised. Yet, it is not self-evident what actually is called for when objectivity of research is demanded. Traditionally the objectivity of research has been associated with the integ- rity of individual scientists: However, studies on implicit biases have shown that individuals are not very good at recognizing their own biases Uhlman and Cohen, For example, even small gifts can have an impact on the prescribing practices of physicians Katz et al.

Because of this, when the grounds for conducting objective medical research are investigated, the perspective has to be shifted from evaluating the attitudes of individuals to examining practices and methods that would best ensure unbiased outcomes. Which methods best promote the objectivity of research have been a debated issue in philosophy of science. The controversies are partly rooted in the intrin- sic complexity of the concept of objectivity.

Daston and Galison , for example, describe how the ideal of mechanical objectivity encouraged atlas makers in the late nineteenth and early twentieth centuries to find ways of depicting nature without the interference of human judgment and interpretation, even if it happened at the expense of describing the details of the object of interest. Thus, the photographs had less diagnostic utility than drawings, despite the fact that the latter were always influenced by the subjectivity of the artists. Achieving objectivity is thought to require removing detrimental subjectiv- ity, and the biases associated with it, from the process, and thereby improv- ing the trustworthiness of results cf.


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  5. Daston and Galison, , pp. According to Douglas , p. Due to the complexity of the term, it is possible to praise a method for producing objective results or denounce it as biased— depending on which of the senses of objectivity is chosen as the ideal to follow. For example, one way of trying to constrain subjectivity and avoid biased results is to aim at making individual judgments redundant by establishing guidelines and procedures that give detailed instructions on how to carry out research.

    Stegenga has argued that meta-analysis falls short of being the platinum standard of evidence: For example, Young et al. Brown , in turn, has argued that the funding structure in the field of biomedicine, that is, the prevalence of industry funding and the pressure to produce commercially applicable results, is creating lacunae in published literature. If the available funding guides research toward searching for only certain types of explana- tions for phenomena and the interests that motivate planning research in this way are not in line with generally accepted goals of research, then it might be the case that the outcomes of research regarded in their entirety have been biased.

    In other words, medical research is not objective. For instance, if fund- ing is available only for those studies on mental illnesses that may produce patentable outcomes, important features of the phenomena may be left unstud- ied Musschenga et al. In the context of medical research, this is particularly worrisome. According to the principles of EBM, the results of meta-analyses and other systematic reviews trump indi- vidual studies, and treatment guidelines are usually based on amalgamated evidence Howick, b. Because of this, the objectivity of medical research should be evaluated by using a concept of objectivity that accommodates the possibility of systematic biases that are caused by factors not belonging to the internal stages of research.

    According to a traditional understanding, practices that take place in the context of discovery, that is, when research questions and hypotheses are developed, do not have an influence on the objectivity of knowledge produc- tion because through rigorous testing any possible biases can be removed in the so-called context of justification. In the light of recent empirical studies on the pharmaceutical industry Sismondo, and philosophical analyses Brown, , however, this assumption should be questioned.

    Contrary to the tradi- tional understanding of the distinction between the contexts of discovery and justification, testing of claims may not weed out all biases. The objectivity and trustworthiness of medical research can be severely compromised because of publication bias or problematic practices that occur in the phases of the alloca- tion of resources, which fall on the discovery side of the discovery-justification distinction.

    If the way of framing research questions and projects results in a skewed understanding of the object of interest, it is possible to talk about the violation of objectivity Brown, The ways in which health-care professionals ranging from clinicians to biomedical scientists come to know and use knowledge, whether as individuals or as groups, are central concerns of medical epistemology.

    Many different claims to knowledge have been identified. Evidence-based medicine EBM is underpinned by the study of the ways in which we can gain knowledge regarding key clinical questions such as the effects of medical interventions, the accuracy of diagnostic tests, and the predictive value of prognostic markers. EBM provides an account of how medical knowledge can be applied to clinical care. EBM not only provides clinicians with a strategy for best practice , but also, underlying that, a philosophy of evidence. While Jeremy Howick provides a critical defense of EBM, [8] most philosophers have raised questions about its legitimacy.

    Key questions asked about hierarchies of evidence concern the legitimacy of ranking methodologies in terms of the strength of support that they supply; [12] [13] how instances of particular methods may move up and down a hierarchy; [14] as well as how different types of evidence, from different levels in the hierarchies, should be combined. Critics of medical research have raised numerous questions regarding the unreliability of medical research.

    Additionally the epistemological virtues of particular aspects of clinical trial methodology have been examined, mostly notably the special place that is given to randomisation , [16] [17] [18] the notion of a blind experiment and the use of a placebo control. There is a large body of work on the ontology of biomedicine, including ontological studies of all aspects of medicine. Ontologies of specific interest to the philosophy of medicine include, for instance: The ontology of general medical science OGMS is an ontology of entities involved in a clinical encounter.

    It includes a set of logical definitions of very general terms that are used across medical disciplines, including: The scope of OGMS is restricted to humans, but many terms can be applied also to other organisms. Medicine simply investigated s the body as machine. While Cartesian dualism dominates clinical approaches to medical research and treatment, the legitimacy of the split between mind and body has been consistently challenged from a variety of perspectives.

    Modern medicine, unlike Galenic medicine which dealt with humours , is mechanistic. For example, when a bit of solid matter such as a poison or a worm impacts upon another bit of matter when it enters the human body , this sets off a chain of motions, giving rise to disease, just as when one billiard ball knocks into another billiard, the latter is set in motion. When the human body is exposed to the solid pathogen, it falls ill, giving rise to the notion of a disease entity.

    Later in the history of modern medicine, particularly by the late nineteenth and twentieth centuries, in nosology which is the classification of disease , the most powerful is the etiogically-defined approach as can be found in the monogenic conception of disease which covers not only infectious agents bacteria, viruses. Clinical medicine, as presented above, is part of a reductionist approach to disease, based ultimately on Cartesian dualism which says that the proper study of medicine is an investigation of the body when the latter is viewed as machine.

    Placebos and placebo effects have generated years of conceptual confusion about what kinds of thing they are. Similarly, example definitions of placebo effects may refer to the subjectivity or the non-specificity of those effects. The distinctions at work in these types of definition: More generally, there is scientific evidence from research investigating placebo phenomena which demonstrates that, for certain conditions such as pain , placebo effects can be both specific and objective in the conventional sense.

    Other attempts to define placebos and placebo effects therefore shift focus away from these distinctions and onto therapeutic effects that are caused or modulated by the context in which a treatment is delivered and the meaning that different aspects of treatments have for patients. The problems arising over the definition of placebos and their effects may be said to be the heritage of Cartesian dualism, under which mind and matter are understood as two different substances. Yet such reports which appear to be genuine pose a threat to Cartesian dualism which provides the ontological underpinning for biomedicine especially in its clinical domain.

    Although most areas of study within the Philosophy of Medicine are concerned with matters of epistemology, there is a growing interest in the metaphysics of medicine, [33] particularly the idea of causality. Philosophers of medicine might not only be interested in how medical knowledge is generated, but also in the nature of such phenomena. Causation is of interest because the purpose of much medical research is to establish causal relationships, e. The scientific processes used to generate causal knowledge give clues to the metaphysics of causation.

    For example, the defining feature of randomised controlled trials RCTs is that they are thought to establish causal relationships, whereas observational studies do not. At least two different causal paradigms in biomedicine have been identified — the Humean, linear, mono-factorial paradigm championed mainly in clinical medicine; and the non-linear, reciprocal, multi-factorial paradigm invoked in epidemiology. From Wikipedia, the free encyclopedia. This section does not cite any sources.

    Please help improve this section by adding citations to reliable sources. Unsourced material may be challenged and removed. February Learn how and when to remove this template message. The Philosophy of Evidence-based Medicine.