Evidence-based medicine (EBM) makes use of explicit procedures for grading evidence for causal claims. Normally, these procedures categorise evidence of correlation produced by statistical trials as better evidence for a causal claim than evidence of mechanisms produced by other methods. We argue, in contrast, that evidence of mechanisms needs to be viewed as complementary to, rather than inferior to, evidence of correlation. In this paper we first set out the case for treating evidence of mechanisms alongside evidence of correlation in (...) explicit protocols for evaluating evidence. Next we provide case studies which exemplify the ways in which evidence of mechanisms complements evidence of correlation in practice. Finally, we put forward some general considerations as to how the two sorts of evidence can be more closely integrated by EBM. (shrink)

Even though the evidence‐based medicine movement (EBM) labels mechanisms a low quality form of evidence, consideration of the mechanisms on which medicine relies, and the distinct roles that mechanisms might play in clinical practice, offers a number of insights into EBM itself. In this paper, I examine the connections between EBM and mechanisms from several angles. I diagnose what went wrong in two examples where mechanistic reasoning failed to generate accurate predictions for how a dysfunctional mechanism would respond to intervention. (...) I then use these examples to explain why we should expect this kind of mechanistic reasoning to fail in systematic ways, by situating these failures in terms of evolved complexity of the causal system(s) in question. I argue that there is still a different role in which mechanisms continue to figure as evidence in EBM: namely, in guiding the application of population‐level recommendations to individual patients. Thus, even though the evidence‐based movement rejects one role in which mechanistic reasoning serves as evidence, there are other evidentiary roles for mechanistic reasoning. This renders plausible the claims of some critics of evidencebased medicine who point to the ineliminable role of clinical experience. Clearly specifying the ways in which mechanisms and mechanistic reasoning can be involved in clinical practice frames the discussion about EBM and clinical experience in more fruitful terms. (shrink)

Evidence-Based Medicine is a relatively new movement that seeks to put clinical med- icine on a firmer scientific footing. I take it as uncontroversial that medical practice should be based on best evidence-the interesting questions concern the details. This paper tries to move towards a coherent and unified account of best evidence in medicine, by exploring in particular the EBM position on RCTs (randomized controlled trials).

Evidence-Based Medicine is a relatively new movement that seeks to put clinical medicine on a firmer scientific footing. I take it as uncontroversial that medical practice should be based on best evidence—the interesting questions concern the details. This paper tries to move towards a coherent and unified account of best evidence in medicine, by exploring in particular the EBM position on RCTs.

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 (...) model diagnostic reasoning abstracted from the rest of clinical reasoning will yield an inadequate representation of diagnosis. Such a distortion of medical reasoning will blind us to whatever implications an adequate epistemology of medicine may have for an understanding of the relation between theoretical and practical knowledge in other contexts. (shrink)

In clinical and agricultural trials, there is the danger that an experimental outcome appears to arise from the causal process or treatment one is interested in when, in reality, it was produced by some extraneous variation in the experimental conditions. The remedy prescribed by classical statisticians involves the procedure of randomization, whose effectiveness and appropriateness is criticized. An alternative, Bayesian analysis of experimental design, is shown, on the other hand, to provide a coherent and intuitively satisfactory solution to the problem.

This essay explores the role of informal logicand its application in the context of currentdebates regarding evidence-based medicine. This aim is achieved through a discussion ofthe goals and objectives of evidence-basedmedicine and a review of the criticisms raisedagainst evidence-based medicine. Thecontributions to informal logic by StephenToulmin and Douglas Walton are explicated andtheir relevance for evidence-based medicine isdiscussed in relation to a common clinicalscenario: hypertension management. This essayconcludes with a discussion on the relationshipbetween clinical reasoning, rationality, andevidence. It is argued that (...) informal logic hasthe virtue of bringing explicitness to the roleof evidence in clinical reasoning, and bringssensitivity to understanding the role ofdialogical context in the need for evidence inclinical decision making. (shrink)

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)

My thesis is that, although medicine is scientific, it is not and can not become a science. After rejecting as flawed an argument attempting to show that medicine is already a science, I argue that a comparison of such basic, defining features as internal aims, criteria of success, and principles regulating the enterprises demonstrate that medicine and science are inherently different. I then argue that while it may be possible to reduce the cognitive content of medicine to biology, medicine itself (...) cannot be reduced, for as an enterprise it possesses features that make it an inappropriate subject of reduction. I conclude by indicating four results that emerge from recognizing that medicine and science are basically distinct. CiteULike Connotea Del.icio.us What's this? (shrink)

Much contemporary debate on the nature of mechanisms centers on the issue of modulating negative causes. One type of negative causability, which I refer to as "causation by absence," appears difficult to incorporate into modern accounts of mechanistic explanation. This paper argues that a recent attempt to resolve this problem, proposed by Benjamin Barros, requires improvement as it overlooks the fact that not all absences qualify as sources of mechanism failure. I suggest that there are a number of additional types (...) of effects caused by absences that need to be incorporated to account for the diversity of causal connections in the biological sciences. Furthermore, it is argued that recognizing natural variability in mechanisms, such as attenuation, leads to some interesting line-drawing issues for contemporary philosophy of mechanisms. (shrink)

Much contemporary debate on the nature of mechanisms centers on the issue of modulating negative causes. One type of negative causability, which I refer to as “causation by absence,” appears difficult to incorporate into modern accounts of mechanistic explanation. This paper argues that a recent attempt to resolve this problem, proposed by Benjamin Barros, requires improvement as it overlooks the fact that not all absences qualify as sources of mechanism failure. I suggest that there are a number of additional types (...) of effects caused by absences that need to be incorporated to account for the diversity of causal connections in the biological sciences. Furthermore, it is argued that recognizing natural variability in mechanisms, such as attenuation, leads to some interesting line-drawing issues for contemporary philosophy of mechanisms. (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)

This book on the philosophy of science argues for an empiricism, opposed to the tradition of David Hume, in which singular rather than general causal claims are primary; causal laws express facts about singular causes whereas the general causal claims of science are ascriptions of capacities or causal powers, capacities to make things happen. Taking science as measurement, Cartwright argues that capacities are necessary for science and that these can be measured, provided suitable conditions are met. There are case studies (...) from both econometrics and quantum mechanics. (shrink)

What role, if any, should emotions play in clinical reasoning and decision making? Traditionally, emotions have been excluded from clinical reasoning and decision making, but with recent advances in cognitive neuropsychology they are now considered an important component of them. Today, cognition is thought to be a set of complex processes relying on multiple types of intelligences. The role of mathematical logic or verbal linguistic intelligence in cognition, for example, is well documented and accepted; however, the role of emotional intelligence (...) has received less attention—especially because its nature and function are not well understood. In this paper, I argue for the inclusion of emotions in clinical reasoning and decision making. To that end, developments in contemporary cognitive neuropsychology are initially examined and analyzed, followed by a review of the medical literature discussing the role of emotions in clinical practice. Next, a published clinical case is reconstructed and used to illustrate the recognition and regulation of emotions played during a series of clinical consultations, which resulted in a positive medical outcome. The paper’s main thesis is that emotions, particularly in terms of emotional intelligence as a practical form of intelligence, afford clinical practitioners a robust cognitive resource for providing quality medical care. (shrink)

The concept of mechanism is analyzed in terms of entities and activities, organized such that they are productive of regular changes. Examples show how mechanisms work in neurobiology and molecular biology. Thinking in terms of mechanisms provides a new framework for addressing many traditional philosophical issues: causality, laws, explanation, reduction, and scientific change.

Proponents of Evidence-based medicine (EBM) do not provide a clear role for basic science in therapeutic decision making. Of what they do say about basic science, most of it is negative. Basic science resides on the lower tiers of EBM's hierarchy of evidence. Therapeutic decisions, according to proponents of EBM, should be informed by evidence from randomised studies (and systematic reviews of randomised studies) rather than basic science. A framework of models explicates the links between the mechanisms of basic science, (...) experimental inquiry, and observed data. Relying on the framework of models I show that basic science often plays a role not only in specifying experiments, but also analysing and interpreting the data that is provided. Further, and contradicting what is implied in EBM's hierarchy of evidence, appeals to basic science are often required to apply clinical research to therapeutic questions. © 2010 Springer Science+Business Media B.V. (shrink)

In this paper I argue that ethics and evidence are intricately intertwined within the clinical practice of differential diagnosis. Too often, when a disease is difficult to diagnose, a physician will dismiss it as being “not real” or “all in the patient’s head.” This is both an ethical and an evidential problem. In the paper my aim is two-fold. First, via the examination of two case studies (late-stage Lyme disease and Addison’s disease), I try to elucidate why this kind of (...) dismissal takes place. Then, I propose a potential solution to the problem. I argue that instead of dismissing a patient’s illness as “not real,” physicians ought to exercise a compassionate suspension of judgment when a diagnosis cannot be immediately made. I argue that suspending judgment has methodological, epistemic, and ethical virtues and therefore should always be preferred to patient dismissal in the clinical setting. (shrink)

Traditionally, mechanistic reasoning has been assigned a negligible role in standard EBM literature, although some recent authors have argued for an upgrade. Even so, the mechanistic reasoning that has received attention has almost exclusively been positive—both in an epistemic sense of claiming that there is a mechanistic chain and in a health-related sense of there being claimed benefits for the patient. Negative mechanistic reasoning has been neglected, both in the epistemic and in the health-related sense. I distinguish three main types (...) of negative mechanistic reasoning and subsume them under a new definition of mechanistic reasoning in the context of assessing medical interventions. This definition is wider than a previous suggestion in the literature. Each negative type corresponds to a range of evidential strengths, and it is argued that there are differences with respect to typical evidential strengths. The variety of negative mechanistic reasoning should be acknowledged in EBM, and it presents a serious challenge to proponents of so-called medical hierarchies of evidence. (shrink)

As the world population ages, the patients per physician ratio keeps on increasing. This is even more important in the domain of chronic pathologies where people are usually monitored for years and need regular consultations.To address this problem, we propose an automated system to monitor a patient population, detecting anomalies in instantaneous data and in their temporal evolution, so that it could alert physicians. By handling the population of healthy patients autonomously and by drawing the physicians' attention to the patients–at-risk, (...) the system allows physicians to spend comparatively more time with patients who need their services. In such a system, the interaction between the patients, the diagnosis module, and the physicians is very important. We have based this system on a combination of stochastic models, fuzzy filters, and strong medical semantics. (shrink)

A resilient issue in research ethics is whether and when a placebo-controlled trial is justified if it deprives research subjects of a recognized treatment. The clinicians' moral duty to provide the best available care seems to require the use of ‘active’ controlled trials that use an established treatment as a control whenever such a therapy is available. In another regard, ACTs are supposedly methodologically inferior to PCTs. Hence, the moral duty of the clinical researcher to use the best methods will (...) favor PCTs. In this target article, I analyze the three reasons for believing that ACTs are inferior to PCTs namely: 1) ACTs lack ‘assay sensitivity’; 2) ACTs do not measure absolute effect size; and 3) ACTs require more participants; and I contend that none are acceptable. Consequently the tension between clinical and research ethics dissolves: the moral duty of the clinician to avoid PCTs is unopposed by methodological considerations. (shrink)

Philosophers of science have insisted that evidence of underlying mechanisms is required to support claims about the effects of medical interventions. Yet evidence about mechanisms does not feature on dominant evidence-based medicine “hierarchies.” After arguing that only inferences from mechanisms (“mechanistic reasoning”)—not mechanisms themselves—count as evidence, I argue for a middle ground. Mechanistic reasoning is not required to establish causation when we have high-quality controlled studies; moreover, mechanistic reasoning is more problematic than has been assumed. Yet where the problems can (...) be overcome, mechanistic reasoning can and should be used as evidence. (shrink)

The standard philosophical definition of placebos offered by Grünbaum is incompatible with Cartwright’s conception of randomized clinical trials. I offer a modified account of placebos that respects this role and clarifies why many current medical trials fail to warrant the conclusions they are typically seen as yielding. I then consider recent changes to guidelines for reporting medical trials and show that pessimism over parsing out the cause of “unblinding” is premature. Specifically, using a trial of antidepressants, I show how more (...) sophisticated statistical analyses can parse out the source of such effects and serve as an alternative to placebo control. (shrink)

The concordance of results that are “robust” across multiple scientific modalities is widely considered to play a critical role in the epistemology of science. But what should we make of those cases where such multimodal evidence is discordant? Jacob Stegenga has recently argued that robustness is “worse than useless” in these cases, suggesting that “different kinds of evidence cannot be combined in a coherent way.” In this article I respond to this critique and illustrate the critical methodological role that robustness (...) plays as an aim of scientific inquiry. (shrink)

Diagnostic errors are more frequently a result of the clinician's failure to combine medical knowledge adequately than of data inaccuracy. Diagnostic reasoning studies are valuable to understand and improve diagnostic reasoning. However, most diagnostic reasoning studies are characterized by some limitations which make these studies seem more simple than diagnostic reasoning in real life situations actually is. These limitations are connected both to the failure to acknowledge components of knowledge used in clinical practice as well as to acknowledge the physician-patient (...) relationship's influence on clinical knowledge and on the reasoning process itself. In addition the modes of reasoning described in these studies frequently is oversimplified. In this paper three simplistic and competing models of diagnostic reasoning are analyzed and criticized, followed by an evaluation of two alternative models proposing a combined view. (shrink)

Among medical researchers and clinicians the dominant view is that it is unethical to deceive patients by prescribing a placebo. This opinion is formalized in a recent policy issued by the American Medical Association (AMA [Chicago, IL]). Although placebos can be shown to be always safe, often effective, and sometimes necessary, doctors are now effectively prohibited from using them in clinical practice. I argue that the deceptive administration of placebos is not subject to the same moral objections that face other (...) forms of deception in clinical practice and medical research. Although deception is normally objectionable on the grounds that it limits autonomy and breaches trust, these grounds do not apply to placebos when they are prescribed within appropriate ethical limits. Patients have reason to prefer that doctors can prescribe placebos in ethically responsible ways. Hence, the AMA has an obligation to endorse and to promote the responsible use of deceptive placebos in clinical practice. (shrink)

Recent efforts to argue that nonepistemic values have a legitimate role to play in assessing scientific models, theories, and hypotheses typically either reject the distinction between epistemic and nonepistemic values or incorporate nonepistemic values only as a secondary consideration for resolving epistemic uncertainty. Given that scientific representations can legitimately be evaluated not only based on their fit with the world but also with respect to their fit with the needs of their users, we show in two case studies that nonepistemic (...) values can play a legitimate role as factors that override epistemic considerations in assessing scientific representations for practical purposes. (shrink)

Exploring informal components of clinical reasoning, we argue that they need to be understood via the analysis of professional wisdom. Wise decisions are needed where action or insight is vital, but neither everyday nor expert knowledge provides solutions. Wisdom combines experiential, intellectual, ethical, emotional and practical capacities; we contend that it is also more strongly social than is usually appreciated. But many accounts of reasoning specifically rule out such features as irrational. Seeking to illuminate how wisdom operates, we therefore build (...) on Aristotle’s work on informal reasoning. His account of rhetorical communication shows how non-formal components can play active parts in reasoning, retaining, or even enhancing its reasonableness. We extend this account, applying it to forms of healthcare-related reasoning which are characterised by the need for wise decision-making. We then go on to explore some of what clinical wise reasoning may mean, concluding with a case taken from psychotherapeutic practice. (shrink)