This paper assesses the epistemic challenges of giving nutrition advice to elite athletes in light of recent philosophical discussion concerning evidence-based practice. Our trust in experts largely depends on the assumption that their advice is based on reliable evidence. In many fields, the evaluation of the reliability of evidence is made on the basis of standards that originate from evidence-based medicine. I show that at the Olympic or professional level, implementing nutritional plans in real-world competitions requires contextualization of knowledge in (...) a way that contravenes the tenets of evidence-based thinking. Nutrition experts need to be able to combine and apply evidence from multiple sources, including the previous successes and failures of particular athletes. I argue that in this sense, the practice of elite sport nutrition embodies casuistic reasoning. (shrink)

In his book “Medical Philosophy: Conceptual issues in Medicine”, Mario Bunge provides a unique account of medical philosophy that is deeply rooted in a realist ontology he calls “systemism”. According to systemism, the world consists of systems and their parts, and systems possess emergent properties that their parts lack. Events within systems may form causes and effects that are constantly conjoined via particular mechanisms. Bunge supports the views of the evidence-based medicine movement that randomized controlled trials (RCTs) provide the best (...) evidence to establish the truth of causal hypothesis; in fact, he argues that _only_ RCTs have this ability. Here, we argue that Bunge neglects the important feature of patients being open systems which are in steady interaction with their environment. We show that accepting this feature leads to counter-intuitive consequences for his account of medical hypothesis testing. In particular, we point out that (i) the confirmation of hypotheses is inherently stochastic and affords a probabilistic account of both confirmation and evidence which we provide here; (ii) RCTs are neither necessary nor sufficient to establish the truth of a causal claim; (iii) testing of causal hypotheses requires taking into account background knowledge and the context within which an intervention is applied. We conclude that there is no “best” research methodology in medicine, but that different methodologies should coexist in a complementary fashion. (shrink)

In the US and UK Births in obstetric units vastly outnumber births that take place outside of an obstetric unit. Still non-obstetric births are increasing in both countries. Is it professionally responsible to support a non-obstetric birth? It is morally responsible to choose to give birth at home? This debate has become heated with those on both sides finding empirical support for their positions. Indeed this moral debate is often carried out in terms of empirical evidence. While to some this (...) debate over the evidence is a distraction from what is genuinely at stake, namely different non-epistemic values, I will argue in this paper that the way forward is to take a closer and more fine grained look at the evidence. This closer look will first require that we distinguish between evidence of risk acceptability and evidence of safety and then focus carefully on evidence of the safety of non-obstetric births compared to obstetric births. (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)

Randomized controlled trials (RCTs) are widely taken as the gold standard for establishing causal conclusions. Ideally conducted they ensure that the treatment ‘causes’ the outcome—in the experiment. But where else? This is the venerable question of external validity. I point out that the question comes in two importantly different forms: Is the specific causal conclusion warranted by the experiment true in a target situation? What will be the result of implementing the treatment there? This paper explains how the probabilistic theory (...) of causality implies that RCTs can establish causal conclusions and thereby provides an account of what exactly that causal conclusion is. Clarifying the exact form of the conclusion shows just what is necessary for it to hold in a new setting and also how much more is needed to see what the actual outcome would be there were the treatment implemented. (shrink)

After describing the disorder of psychopathy, I examine the theories and the evidence concerning the psychopaths’ deficient moral capacities. I first examine whether or not psychopaths can pass tests of moral knowledge. Most of the evidence suggests that they can. If there is a lack of moral understanding, then it has to be due to an incapacity that affects not their declarative knowledge of moral norms, but their deeper understanding of them. I then examine two suggestions: it is their deficient (...) practical reason or their stunted emotions that are at fault. The evidence supports both explanations. I conclude with an overview of the debate concerning whether they are morally or legally responsible for their actions. (shrink)

Ascriptions of objectivity carry significant weight. But they can also cause confusion because wildly different ideas of what it means to be objective are common. Faced with this, some philosophers have argued that objectivity should be eliminated. I will argue, against one such position, that objectivity can be useful even though it is plural. I will then propose a contextualist approach for dealing with objectivity as a way of rescuing what is useful about objectivity while acknowledging its plurality.

The evidence from randomized controlled trials (RCTs) is widely regarded as supplying the ‘gold standard’ in medicine—we may sometimes have to settle for other forms of evidence, but this is always epistemically second-best. But how well justified is the epistemic claim about the superiority of RCTs? This paper adds to my earlier (predominantly negative) analyses of the claims produced in favour of the idea that randomization plays a uniquely privileged epistemic role, by closely inspecting three related arguments from leading contributors (...) to the burgeoning field of probabilistic causality—Papineau, Cartwright and Pearl. It concludes that none of these further arguments supplies any practical reason for thinking of randomization as having unique epistemic power. IntroductionWhy the issue is of great practical importance—the ECMO casePapineau on the ‘virtues of randomization’Cartwright on causality and the ‘ideal’ randomized experimentPearl on randomization, nets and causesConclusion. (shrink)

It is surely obvious that medicine, like any other rational activity, must be based on evidence. The interest is in the details: how exactly are the general principles of the logic of evidence to be applied in medicine? Focussing on the development, and current claims of the ‘Evidence-Based Medicine’ movement, this article raises a number of difficulties with the rationales that have been supplied in particular for the ‘evidence hierarchy’ and for the very special role within that hierarchy of randomized (...) controlled trials (and meta-analyses of the results of randomized controlled trials). The point is not at all to question the application of a scientific approach to evidence in medicine, but, on the contrary, to indicate a number of areas where philosophers of science can contribute to a proper implementation of exactly that scientific-evidential approach. (shrink)

This paper advocates for making epistemic interests a central object of philosophical analysis in epistemology and philosophy of science. It is argued that the importance of epistemic interests derives from their fundamental importance for the notion of objectivity. Epistemic interests are defined as individuated by a set of objectives, each of which represents a dimension of the search for truth. Among these dimensions, specificity, sensitivity, and productivity are discussed in detail. It is argued that the relevance of productivity is often (...) overlooked in debates about the ends and means of science. A definition of the objectivity of inquiry is proposed that takes the notion of epistemic interest as its starting point. (shrink)

Comparative syllogism is a type of scientific reasoning widely used, explicitly or implicitly, for inferences from observations to conclusions about effectiveness, but its philosophical significance has not been fully elaborated or appreciated. In its simplest form, the comparative syllogism derives a conclusion about the effectiveness of a factor (e.g. a treatment or an exposure) on a certain property via an experiment design using a test (experimental) group and a comparison (control) group. Our objective is to show that the comparative syllogism (...) can be understood as encoding a simulation view of counterfactuals, in that counterfactual situations are conceptual constructs that can be correctly simulated by homogeneous comparison groups. In this simulation view, the empirical data from the comparison groups play an evidential role in the evaluation of counterfactuals and in obtaining counterfactual knowledge. We further indicate how successful experimental designs can help us to obtain correct simulations, and thus to bring us to scientifically-empirically based counterfactual knowledge. (shrink)

Within the evidence-based medicine construct, clinical expertise is acknowledged to be both derived from primary experience and necessary for optimal medical practice. Primary experience in medical practice, however, remains undervalued. Clinicians’ primary experience tends to be dismissed by EBM as unsystematic or anecdotal, a source of bias rather than knowledge, never serving as the “best” evidence to support a clinical decision. The position that clinical expertise is necessary but that primary experience is untrustworthy in clinical decision-making is epistemically incoherent. Here (...) we argue for the value and utility of knowledge gained from primary experience for the practice of medicine. Primary experience provides knowledge necessary to diagnose, treat, and assess response in individual patients. Hierarchies of evidence, when advanced as guides for clinical decisions, mistake the relationship between propositional and experiential knowledge. We argue that primary experience represents a kind of medical knowledge distinct from the propositional knowledge produced by clinical research, both of which are crucial to determining the best diagnosis and course of action for particular patients. (shrink)

This article examines the relationship between the precautionary principle and the well-known Hill criteria of causation. Some have charged that the Hill criteria are anti-precautionary because the...

Consensus conferences are social techniques which involve bringing together a group of scientific experts, and sometimes also non-experts, in order to increase the public role in science and related policy, to amalgamate diverse and often contradictory evidence for a hypothesis of interest, and to achieve scientific consensus or at least the appearance of consensus among scientists. For consensus conferences that set out to amalgamate evidence, I propose three desiderata: Inclusivity, Constraint, and Evidential Complexity. Two examples suggest that consensus conferences can (...) readily satisfy Inclusivity and Evidential Complexity, but consensus conferences do not as easily satisfy Constraint. I end by discussing the relation between social inclusivity and the three desiderata. (shrink)

Robustness is a common platitude: hypotheses are better supported with evidence generated by multiple techniques that rely on different background assumptions. Robustness has been put to numerous epistemic tasks, including the demarcation of artifacts from real entities, countering the “experimenter’s regress,” and resolving evidential discordance. Despite the frequency of appeals to robustness, the notion itself has received scant critique. Arguments based on robustness can give incorrect conclusions. More worrying is that although robustness may be valuable in ideal evidential circumstances (i.e., (...) when evidence is concordant), often when a variety of evidence is available from multiple techniques, the evidence is discordant. †To contact the author, please write to: Jacob Stegenga, Department of Philosophy, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093; e‐mail: [email protected]. (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)

Harms of medical interventions are systematically underestimated in clinical research. Numerous factors—conceptual, methodological, and social—contribute to this underestimation. I articulate the depth of such underestimation by describing these factors at the various stages of clinical research. Before any evidence is gathered, the ways harms are operationalized in clinical research contributes to their underestimation. Medical interventions are first tested in phase 1 ‘first in human’ trials, but evidence from these trials is rarely published, despite the fact that such trials provide the (...) foundation for assessing the harm profile of medical interventions. If a medical intervention is deemed safe in a phase 1 trial, it is tested in larger phase 2 and 3 clinical trials. One way to think about the problem of underestimating harms is in terms of the statistical ‘power’ of a clinical trial—the ability of a trial to detect a difference of a certain effect size between the experimental group and the control group. Power is normally thought to be pertinent to detecting benefits of medical interventions. It is important, though, to distinguish between the ability of a trial to detect benefits and the ability of a trial to detect harms. I refer to the former as power-B and the latter as power-H. I identify several factors that maximize power-B by sacrificing powerH in phase 3 clinical trials. If a medical intervention is approved for general use, it is evaluated by phase 4 post-market surveillance. Phase 4 surveillance of harms further contributes to underestimating the harm profile of medical interventions. At every stage of clinical research the hunt for harms is shrouded in secrecy, which further contributes to the underestimation of the harm profiles of medical interventions. (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.

Evidence-Based Medicine (EBM) developed from the work of clinical epidemiologists at McMaster University and Oxford University in the 1970s and 1980s and self-consciously presented itself as a "new paradigm" called "evidence-based medicine" in the early 1990s. The techniques of the randomized controlled trial, systematic review and meta-analysis have produced an extensive and powerful body of research. They have also generated a critical literature that raises general concerns about its methods. This paper is a systematic review of the critical literature. It (...) finds the description of EBM as a Kuhnian paradigm helpful and worth taking further. Three kinds of criticism are evaluated in detail: criticisms of procedural aspects of EBM (especially from Cartwright, Worrall and Howick), data showing the greater than expected fallibility of EBM (Ioaanidis and others), and concerns that EBM is incomplete as a philosophy of science (Ashcroft and others). The paper recommends a more instrumental or pragmatic approach to EBM, in which any ranking of evidence is done by reference to the actual, rather than the theoretically expected, reliability of results. Emphasis on EBM has eclipsed other necessary research methods in medicine. With the recent emphasis on translational medicine, we are seeing a restoration of the recognition that clinical research requires an engagement with basic theory (e.g. physiological, genetic, biochemical) and a range of empirical techniques such as bedside observation, laboratory and animal studies. EBM works best when used in this context. (shrink)

Why do classic biostatistical studies, alleged to provide causal explanations of effects, often fail? This article argues that in statistics-relevant areas of biology—such as epidemiology, population biology, toxicology, and vector ecology—scientists often misunderstand epistemic constraints on use of the statistical-significance rule (SSR). As a result, biologists often make faulty causal inferences. The paper (1) provides several examples of faulty causal inferences that rely on tests of statistical significance; (2) uncovers the flawed theoretical assumptions, especially those related to randomization, that likely (...) contribute to flawed biostatistics; (3) re-assesses the three classic (SSR-warrant, avoiding-selection-bias, and avoiding-confounders) arguments for using SSR only with randomization; and (4) offers five new reasons for biologists to use SSR only with randomized experiments. (shrink)

The present paper deals with the problem of evaluating empirical evidence for therapeutic decisions in medicine. The article discusses the views of Nancy Cartwright and John Worrall on the function that randomization plays in ascertaining causal relations with reference to the therapies applied. The main purpose of the paper is to present a general idea of alternative method of evaluating empirical evidence. The method builds on data analysis that makes use of rough set theory. The first attempts to apply the (...) method show that it is an interesting alternative to randomized controlled trials. (shrink)

In this paper I look at causality in the context of intervention research, and discuss some problems faced in the evaluation of causal hypotheses via interventions. I draw attention to a simple problem for evaluations that employ randomized controlled trials. The common alternative to randomized trials, the observational study, is shown to face problems of a similar nature. I then argue that these problems become especially acute in cases where the intervention is complex (i.e. that involves intervening in a complex (...) system). Finally, I consider and reject a possible resolution of the problem involving the simulation of complex interventions. The conclusion I draw from this is that we need to radically reframe the way we think about causal inference in complex intervention research. (shrink)

One way to make philosophy of science more socially relevant is to attend to specific scientific practises that affect society to a great extent. One such practise is biomedical research. This paper looks at contemporary U.S. biomedical research in particular and argues that it suffers from important epistemic, moral and socioeconomic failings. It then discusses and criticises existing approaches to improve on the status quo, most prominently by Thomas Pogge (a political philosopher), Joseph Stiglitz (a Nobel-prize winning economist) and James (...) Robert Brown (a philosopher of science). Finally, it sketches an alternative proposal and argues for its superiority. The proposal has four components: changing the intellectual property regime; instituting independent clinical research; aligning innovators' and patients' interests; and enacting additional regulation. (shrink)

I present an alternative account of causation in the biomedical and social sciences according to which the meaning of causal claims is given by their inferential relations to other claims. Specifically, I will argue that causal claims are inferentially related to certain evidential claims as well as claims about explanation, prediction, intervention and responsibility. I explain in some detail what it means for a claim to be inferentially related to another and finally derive some implication of the proposed account for (...) the epistemology, semantics and metaphysics of causation. (shrink)

Francesco Guala once wrote that ‘The problem of extrapolation is a minor scandal in the philosophy of science’. This paper agrees with the statement, but for reasons different from Guala’s. The scandal is not, or not any longer, that the problem has been ignored in the philosophy of science. The scandal is that framing the problem as one of external validity encourages poor evidential reasoning. The aim of this paper is to propose an alternative—an alternative which constitutes much better evidential (...) reasoning about target systems of interest, and which makes do without consideration of external validity. (shrink)

November 2009’s announcement of the USPSTF’s recommendations for screening for breast cancer raised a firestorm of objections. Chief among them were that the panel had insufficiently valued patients’ lives or allowed cost considerations to influence recommendations. The publicity about the recommendations, however, often either simplified the actual content of the recommendations or bypassed significant methodological issues, which a philosophical examination of both the science behind screening recommendations and their import reveals. In this article, I discuss two of the leading ethical (...) considerations at issue in screening recommendations: respect for patient autonomy and beneficence and then turn to the most significant methodological issues raised by cancer screening: the potential biases that may infect a trial of screening effectiveness, the problem of base rates in communicating risk, and the trade-offs involved in a judgment of screening effectiveness. These issues reach more broadly, into the use of “evidence-based” medicine generally, and have important implications for informed consent. (shrink)

Decision-making procedures in medical practice are often analysed by both philosophers of science and ethicists, as well as statisticians, clinicians and methodologists. The paper focuses on decisions made by patients in situations of moral dilemma. The main purpose is to analyse the strategies used in resolving such dilemmas. First, the concept of a ‘situation of moral dilemma’ is clarified. Then, two types of strategies for resolving such situations are distinguished. The first strategy requires revising the patient’s belief system or moral (...) orientation. The second one includes a group of non-revision beliefs strategies (NRB). The authors argue in support of the thesis that NRB strategies are, in fact, the patient’s first choice when it comes to resolving moral dilemmas. The paper analyses situations where the NRB strategies may prove effective, as well as situations where they fail and where the solution of the moral dilemma must be addressed by revising the accepted belief system. The findings will help to better understand patients’ decision-making processes. (shrink)

After the middle of the twentieth century, symptoms gradually appeared which were collectively called the “crisis of medicine”. This crisis gave philosophy, which had been abstracted from medicine since the mid-nineteenth century, an opportunity to reflect. Medical philosophers attributed the crisis to the inflation of the scientific and technical aspects and, consequently, to the weakening of the human aspects of medicine. Therefore, reflection on the nature of medicine became one of the central issues of philosophy in medicine.In this article, I (...) will first highlight the need to study the nature of medicine, explain the various concpetions of the nature of modern medicine - based on the dichotomy- science vs. art, and show their inadequacy and inappropriatness. Finally, I will provide a model to the nature of medicine beyond the realm of science / art. In this model, medicine is a scientific practice, based on judgment, dialogue, communication and social order. This model faces teleological, epistemological, scientific, political, and professional challenges that require serious and continuous reflection on the nature of medicine. (shrink)

Scientific consensus is widely deferred to in public debates as a social indicator of the existence of knowledge. However, it is far from clear that such deference to consensus is always justified. The existence of agreement in a community of researchers is a contingent fact, and researchers may reach a consensus for all kinds of reasons, such as fighting a common foe or sharing a common bias. Scientific consensus, by itself, does not necessarily indicate the existence of shared knowledge among (...) the members of the consensus community. I address the question of under what conditions it is likely that a consensus is in fact knowledge based. I argue that a consensus is likely to be knowledge based when knowledge is the best explanation of the consensus, and I identify three conditions—social calibration, apparent consilience of evidence, and social diversity, for knowledge being the best explanation of a consensus. (shrink)

Modern health care relies extensively on the use of technologies for assessing and treating patients, so it is important to be certain that health care technologies perform their professed functions in an effective and safe manner. Philosophers of technology have developed methods to assign and evaluate the functions of technological products, the major elements of which are described in the ICE theory. This paper questions whether the standard of evidence advocated by the ICE theory is adequate for ascribing and assessing (...) technologies employed in health care. The paper proposes that the general problem with the standard of evidence embodied in the ICE theory is too permissive for assessing medical technologies, in that it does not take into account the relative benefit and harm of medical technologies in ensuring safe functional performance in patients. The paper illustrates how evidence-based medicine has demonstrated the value of clinical research methods, including observational studies, randomized and non-randomized clinical trials, and formal techniques, such as meta-analysis, to measure therapeutic effectiveness. I argue, therefore, that evidence from clinical research studies should take precedence over the testimonial evidence and other types of non-clinical evidence, in providing justification for health technologies. (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)

Increasing philosophical attention is being directed to the rapidly growing discipline of evidence-based medicine. Philosophical discussions of EBM, however, remain narrowly focused on randomization, mechanisms, and the sociology of EBM. Other aspects of EBM have been all but ignored, including the nature of clinical reasoning and the question of whether it can be standardized; the application of EBM principles to the logic, value, and ethics of diagnosis and prognosis; evidence synthesis ; and the nature and ethics of placebo controls. Philosophical (...) analysis in each of these areas has the potential to enhance the discussion of EBM methodology and practice. (shrink)

This paper explores ethical concerns arising in healthcare integration. We argue that integration is necessary imperative for meeting contemporary and future healthcare challenges, a far stronger evidence base for the conditions of its effectiveness is required. In particular, given the increasing emphasis at the policy level for the entire healthcare infrastructure to become better integrated, our analysis of the ethical challenges that follow from the logic of integration itself is timely and important and has hitherto received insufficient attention. We evaluated (...) an educational intervention which aims to improve child health outcomes by making transitions between primary to secondary care more efficient, ensuring children and parents are better supported throughout. The programme provided skills for trainee paediatricians and general practitioners in co-designing integrated clinical services. The key ethical challenges of integrated care that arose from a clinical perspective are: professional identity and autonomy in an integrated working environment; the concomitant extent of professional responsibility in such an environment; and the urgent need for more evidence to be produced on which strategies for integrating at scale can be based. From our analysis we suggest a tentative way forward, viewed from a normative position broadly situated at the intersection of deontology and care ethics. We adopt this position because the primary clinical ethical issues in the context of integrated care concern: how to ensure that all duties of care to individual patients are met in a newly orientated working environment where clinical responsibility may be ambiguous; and the need to orientate care around the patient by foregrounding their autonomous preferences and ensuring good patient clinician relationships in clinical decision-making. (shrink)

There has been much philosophical interest regarding the ‘hierarchy of evidence’ used to determine which study designs are of most value for reporting on questions of effectiveness, prognosis, and so on. There has been much less philosophical interest in the choice of outcome measures with which the results of, say, an RCT or a cohort study are presented. In this paper, we examine the FDA’s recently published guidelines for assessing the psychometric adequacy of patient-reported outcome measures. We focus on their (...) recommendations for demonstrating content validity and also for how researchers should weigh up the sum of psychometric evidence when choosing these measures. We argue that questions regarding judgment and understanding meaning of these measures should play a more central role in determining their adequacy. (shrink)

The existing philosophical views on what is the meaning of causality adequate to medicine are vastly divided. We approach this question and offer two arguments in favor of pluralism regarding concepts of causality. First, we analyze the three main types of research designs (randomized-controlled trials, observational epidemiology and laboratory research). We argue, using examples, that they allow for making causal conclusions that are best understood differently in each case (in agreement with a version of manipulationist, probabilistic and mechanistic definitions, respectively). (...) Second, we analyze clinical practice and argue that these manipulationist, probabilistic and mechanistic causal claims can be used as evidence for different therapeutic decisions. We differentiate among ‘predicting’ that does not change the relata of causal claims, (mechanistic) ‘interferences’, and ‘interventions’ in the strict sense that act on causes to change effects. The central conclusion is that causal claims agreeing with diverse concepts of causality can deliver evidence for different types of therapeutic decisions. (shrink)

The replication crisis has spawned discussions on the meaning of replication. In fact, in order to determine whether an experiment fails to replicate, it is necessary to establish what replication is. This is, however, a difficult task, as it is possible to attribute different meanings to it. This paper offers a solution to this problem of ambiguity by engineering a concept of replication that, if compared to other proposals, stands out for being not only broadly applicable but also sufficiently specific. (...) It features a minimal level of operationalism, which would otherwise limit its applicability, while it heavily relies on replication’s specific epistemic functions, which are inter-disciplinary. Another merit is its context sensitivity, which enables it to differentiate instances of replication from non-instances of replication in every scientific discipline according to the discipline’s own standards. (shrink)

It has recently been argued that successful evidence-based policy should rely on two kinds of evidence: statistical and mechanistic. The former is held to be evidence that a policy brings about the desired outcome, and the latter concerns how it does so. Although agreeing with the spirit of this proposal, we argue that the underlying conception of mechanistic evidence as evidence that is different in kind from correlational, difference-making or statistical evidence, does not correctly capture the role that information about (...) mechanisms should play in evidence-based policy. We offer an alternative account of mechanistic evidence as information concerning the causal pathway connecting the policy intervention to its outcome. Not only can this be analyzed as evidence of difference-making, it is also to be found at any level and is obtainable by a broad range of methods, both experimental and observational. Using behavioral policy as an illustration, we draw the implications of this revised understanding of mechanistic evidence for debates concerning policy extrapolation, evidence hierarchies, and evidence integration. (shrink)

This article examines an often neglected topic in the history of science, namely clinical observation, specifically the objectivity and knowledge production associated with therapeutic trials. It will describe an eighteenth and nineteenth century pharmacological concept of objectivity and exemplify that concept using late nineteenth century European cocaine research. As conceived within clinical drug research, this concept of objectivity does not correspond with those described by Daston and Galison in their seminal book Objectivity (2007). I will explore the implications of this (...) “new” concept of objectivity—as compared to the “old” ones postulated by Daston and Galison—for their core propositions. (shrink)

While practitioners think highly of randomized studies, some philosophers argue that there is no epistemic reason to randomize. Here I show that their arguments do not entail their conclusion. Moreover, I provide novel reasons for randomizing in the context of interventional studies. The overall discussion provides a unified framework for assessing baseline balance, one that holds for interventional and observational studies alike. The upshot: practitioners’ strong preference for randomized studies can be defended in some cases, while still offering a nuanced (...) approach to evidence-appraisal, one where not all non-randomized studies are treated equally. (shrink)

Evidence-based medicine (EBM) puts forward a hierarchy of evidence for informing therapeutic decisions. An unambiguous interpretation of how to apply EBM's hierarchy has not been provided in the clinical literature. However, as much as an interpretation is provided proponents suggest a categorical interpretation. The categorical interpretation holds that all the results of randomised trials always trump evidence from lower down the hierarchy when it comes to informing therapeutic decisions. Most of the critical replies to EBM react to this interpretation. While (...) proponents of EBM can avoid some of the problems raised by critics by suitably limited the claims made on behalf of the hierarchy, further problems arise. If EBM is to inform therapeutic decisions then a considerably more restricted, and context dependent interpretation of EBM's hierarchy is needed. (shrink)