Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is (...) frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs. (shrink)

The explanatory/pragmatic-trial distinction enjoys a burgeoning philosophical and medical literature and a significant contingent of support among philosophers and healthcare stakeholders as an important way to assess the design and results of randomized controlled trials. A major motivation has been the need to provide relevant, generalizable data to drive healthcare decisions. While talk of pragmatic and explanatory trials could be seen as convenient shorthand, the distinction can also be seen as harboring deeper issues related to inferential (...) strategies used to evaluate causal claims regarding medical treatments. A comprehensive, critical analysis of the distinction and underlying epistemological framework upon which the distinction is based, particularly with respect to treatment effectiveness, has yet to be forthcoming. I provide this, analyzing the distinction’s relationship to generalizability and cognate distinctions between ideal conditions and real-world practice, internal and external validity, and efficacy and effectiveness. I also analyze recent philosophical work that relies on the explanatory/pragmatic-trial distinction and that advocates for more pragmatic trials. I conclude that as an organizing principle for trial-design decisions and trial evaluation, the explanatory/pragmatic-trial distinction is conceptually problematic and not as useful as its proponents seem to think. Since some pragmatic-trial features can be inimical to establishing treatment effectiveness, pragmatic-trial features should not be conflated with pragmatic trials’ avowed goals. If the distinction is to be useful, it and some associated concepts, including generalizability, should be reformulated, lest they continue to underlie a medical epistemology that could contribute to methodologically flawed and potentially unethical advice for the design and interpretation of trials. (shrink)

Pragmatic trials aim to directly inform health care decision-making through the collection of so-called ‘real world data’ from observations of comparative treatment effects in clinical practice. In order to ensure the applicability and feasibility of a pragmatic trial, design features may be necessary that deviate from standard research ethics requirements. Examples are traditional requirements to seek written informed consent and to perform extensive data and safety monitoring. Proposals for deviations from standard research ethics practice have resulted in controversy about (...) their ethical acceptability. One of the justifications for altered procedures is the allegedly high social value of pragmatic trials. In order to properly operationalize the concept in the ethical assessment of pragmatic trial designs, specification is warranted. We identified three determinants from common claims about a pragmatic trial's social value: the extent to which the research question has real world relevance, the trial design's ability to generate a real world answer and the probability of direct uptake of the results by decision-makers in practice. Subsequently, we discuss how these determinants should be applied to the practice of pragmatic trials, and to what extent they might be applicable to explanatory trials. (shrink)

Norman Kretzmann's recent analysis of the natural law slogan ``lex iniusta non est lex'' (an unjust law is not a law) demonstrates the coherence of the slogan and makes a case for its practical value, but I shall argue that it also ends up showing that the slogan fails to mark any interesting conceptual or practical division between natural law and legal positivist views about the nature of law. I argue that this is a happy result. The non-est-lex slogan has (...) been used to exaggerate the extent of disagreement about the nature of law and has diverted critics of natural law theory from recognizing that the main disagreement between natural lawyers and legal positivists centres on theories of practical reason and how they affect our understanding of the relationship between law and morality. This extends the debate about the nature of law somewhat beyond the traditional boundaries of philosophy of law, but these boundaries are due in part to the diversion created by debate over the non-est-lex slogan. Recognizing that the non-est-lex slogan fails on its own to mark any interesting practical or conceptual division between natural law theories and legal positivism should therefore focus and encourage debate on matters of genuine substance between these outlooks. The disagreement, however, may turn out to be primarily metaphysical and explanatory and not normative in nature. (shrink)

The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees should prohibit all other, (...) lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated. (shrink)

We studied changes in eligibility criteria--the largest impediment to patient accrual--in two samples of clinical trials. Trials from the NSABP (National Surgical Adjuvant Breast and Bowel Program) and POG (Pediatric Oncology Group) were analyzed. After eliminating duplications, the criteria in each protocol were enumerated and classified according to a novel schema. NSABP trials contained significantly more criteria than POG trials, and added precision criteria (making study populations homogeneous) at a faster rate than POG studies. The difference (...) between NSABP studies (explanatory trials) and POG studies (pragmatic trials) suggest that large numbers of eligibility criteria are not necessary for quality studies. We recommend that: (1) the inclusion/exclusion criteria distinction be abandoned; (2) eligibility criteria be explicitly justified; (3) the need for each criterion be assessed when new trials are planned; (4) criteria in phase III trials restricting patient accrual be minimized; and (5) further research be done to assess the impact of criteria on generalizability. (shrink)

Reasoning by jurors concerning whether an accused person should be convicted of committing a crime is a kind of casual inference. Jurors need to decide whether the evidence in the case was caused by the accused’s criminal action or by some other cause. This paper compares two computational models of casual inference: explanatory coherence and Bayesian networks. Both models can be applied to legal episodes such as the von Bu¨low trials. There are psychological and computational reasons for preferring (...) the explanatory coherence account of legal inference. (shrink)

Pragmatic comparative effectiveness randomized controlled trials evaluate the effectiveness of one interventions under real-world clinical conditions. The results of ceRCTs are often directly generalizable to everyday clinical practice, providing information critical to decision-making by patients, clinicians, and healthcare policymakers. The PRECIS-2 framework identifies nine domains that serve to score a trial on a continuum between very explanatory to very pragmatic. According to the framework, pragmatic trials may have one or more of the following features: there are fewer (...) eligibility criteria for participants, in an... (shrink)

This methodological discussion invites critical reflection about the procedures used to analyze the contribution of qualitative and mixed methods research to nursing trials by mounting an argument that these should rest on multiple publications produced about a project, rather than a single article. We illustrate the value‐added of this approach with findings from a qualitative, cross‐case analysis of three critical case exemplars from nursing researchers that each used a qualitative approach with a mixed method phase. The holistic lens afforded (...) by a case‐based approach informs nursing inquiry by documenting that the critical case exemplars presented evidence of (a) a sustained commitment of resources and expertise for the qualitative methods that extended across more than one phase of the trial, (b) the impact of the qualitative methods on the trial or its aftermath, (c) deploying a theoretical or conceptual framework for a variety of purposes, and (d) integrating qualitative and quantitative data for purposes of extending explanatory power. Findings challenge the practice of linking purposes served by qualitative and mixed methods to a single trial phase. (shrink)

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials (...) has grown substantially in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (shrink)

In this essay, we defend the design of the Salk polio vaccine trial and try to put some limits on the role schemata should play in designing clinical research studies. Our presentation is structured as a response to de Freitas and Pietrobon who identified the CONSORT statement as a schema that would have, had it existed at the time, ruled out the design of the Salk polio vaccine trial of 1954 in favor of a completely randomized controlled clinical trial. We (...) argue that large-scale public health interventions often require evidence beyond simple efficacy, the limit of what an RCT can provide, and that the design actually adopted for the Salk trial represented a reasonable—albeit imperfect—compromise. This is of more than historical interest in that many contemporary studies are of the scale and scope to require a more pragmatic, rather than explanatory, approach to study design. (shrink)

Madole & Harden's assertion that the effects derived from within-family genome-wide association studies (GWASs) and from randomized controlled trials (RCTs) are equivalent is misleading. GWASs are substantially more “non-unitary, non-uniform, and non-explanatory” than RCTs. While the within-family GWAS bring us closer to identifying genetic causes, whether it will change behavioral genetics into a causal science is an open question.

Social anxiety disorders are among the most prevalent mental disorders, with high impact on the life of an affected social system and its individual social system members. We developed a manualized disorder-specific integrative systemic and family therapy for SAD, and evaluated its feasibility in a pilot randomized controlled trial. The ISFT is inspired by Helm Stierlin’s concept of related individuation developed during the early 1980s, which has since continued to be refined. It integrates solution-focused language, social network diagnostics, and genogram (...) work, as well as resource- and problem orientation for both case conceptualization and therapy planning. Post-Milan symptom prescription to fluidize the presented symptoms is one of the core interventions in the ISFT. Theoretically, the IFST is grounded in radical constructivism and “Cybern-Ethics,” multi-directional partiality, and a both/and attitude toward a disorder-specific vs. non-disorder-specific therapy approach. SAD is understood from the viewpoint of social systems theory, especially in adaptation to a socio-psycho-biological explanatory model of social anxiety. In a prospective multicenter, assessor-blind pilot RCT, we included 38 clients with SAD : 18 patients participated in the ISFT, and 20 patients in Cognitive Behavioral Therapy. Within-group, simple-effect intention-to-treat analyses showed significant reduction in social anxiety, while intention-to-treat mixed-design ANOVA demonstrated the advantage of ISFT. Per-protocol analyses supported these results. The remission rate based on blind diagnosticians’ ratings was good to satisfactory ; this has yet to be verified in a subsequent confirmatory RCT. The article will present the ISFT rationale and manual, including a special focus on multi-person settings, and the central findings from our pilot RCT. (shrink)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose (...) a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

Growing interest in embedded research approaches—where research is incorporated into clinical care—has spurred numerous studies to generate knowledge relevant to the real-world needs of patients and other stakeholders. However, it also has presented ethical challenges. An emerging challenge is how to understand the nature and extent of investigators’ obligations to patient-subjects. Prior scholarship on investigator duties has generally been grounded upon the premise that research and clinical care are distinct activities, bearing distinct duties. Yet this premise—and its corresponding implications—are challenged (...) when research and clinical care are deliberately integrated. After presenting three case studies from recent pragmatic clinical trials, we identify six differences between explanatory trials and embedded research that limit the application of existing scholarship for ascertaining investigator duties. We suggest that these limitations indicate a need to account for the implications of usual care and to move beyond a narrow focus on the investigator-subject dyad, one that better reflects the team- and institution-based nature of contemporary health systems. (shrink)

The use of complementary and alternative medicine is increasing in the Western world. However, there is no clear evidence of effect of alternative therapies. Moreover, there is no consensus between practitioners and researchers as to the right way of assessing the efficacy of alternative therapies. To investigate practitioners’ perspective on evidence and ways of assessing efficacy twelve in-depth interviews were conducted in Denmark with acupuncturists, including physicians practising acupuncture, acupuncturists with a health-related background, and acupuncturists without a health-related background. Two (...) themes predominated the study, first, the interviewees’ general reflections on how it is possible to establish knowledge about an effect of acupuncture; and second the interviewees’ reflections on the use of randomized controlled trials in acupuncture, including obstacles and alternatives to conducting randomized controlled trials. Further, two conceptions of what constitutes evidence were identified: a biomedical conception and an experience-based conception. Most interviewees were sceptical about the use of randomized controlled trials in acupuncture. Two reasons, especially, were given for this scepticism. First, practical and instrumental reasons concerning the specific elements of the randomized controlled trial or relating to limited resources; and second, value-based reasons are concerning the nature of acupuncture. However, the interviewees were really opposed only to a certain kind of randomized controlled trial, the so-called explanatory trial. They would actually welcome a pragmatic trial. The study gives valuable insight into an under explored field and provide a platform for further investigation, and a better informed discussion of the subject. (shrink)

The triumphal advance of the beings from logical space seems less formidable from the inside. This chapter deals with those enthusiasts who are even now preparing to bring on the impossible world. Trial‐and‐error modal logic is not the only way to take modality as primitive. There is also the option of reducing possible worlds to maximal consistent “books” of propositions. The books may be enough like possible worlds so that at least some of the explanatory power of possible worlds (...) semantics carries over. There are unproblematic mathematical entities that can be regarded as representing distributions of matter in space‐time, and thereby as representing the possible worlds where matter is so distributed. An account is to be found in Quince's "Propositional Objects." According to classical mathematics, these representatives do form a set. But propositions are sometimes conceived differently, as language independent entities that nevertheless have something analogous to syntactic structure. (shrink)

Behavior genetics is a controversial science. For decades, scholars have sought to understand the role of heredity in human behavior and life-course outcomes. Recently, technological advances and the rapid expansion of genomic databases have facilitated the discovery of genes associated with human phenotypes such as educational attainment and substance use disorders. To maximize the potential of this flourishing science, and to minimize potential harms, careful analysis of what it would mean for genes to be causes of human behavior is needed. (...) In this paper, we advance a framework for identifying instances of genetic causes, interpreting those causal relationships, and applying them to advance causal knowledge more generally in the social sciences. Central to thinking about genes as causes is counterfactual reasoning, the cornerstone of causal thinking in statistics, medicine, and philosophy. We argue that within-family genetic effects represent the product of a counterfactual comparison in the same way as average treatment effects (ATEs) from randomized controlled trials (RCTs). Both ATEs from RCTs and within-family genetic effects are shallow causes: They operate within intricate causal systems (non-unitary), produce heterogeneous effects across individuals (non-uniform), and are not mechanistically informative (non-explanatory). Despite these limitations, shallow causal knowledge can be used to improve understanding of the etiology of human behavior and to explore sources of heterogeneity and fade-out in treatment effects. (shrink)

This paper evaluates four competing psychological explanations for why the jury in the O.J. Simpson murder trial reached the verdict they did: explanatory coherence, Bayesian probability theory, wishful thinking, and emotional coherence. It describes computational models that provide detailed simulations of juror reasoning for explanatory coherence, Bayesian networks, and emotional coherence, and argues that the latter account provides the most plausible explanation of the jury's decision.

A common and driving assumption in agricultural research is that the introduction of research trials, new practices and innovative technologies will result in technology adoption, and will subsequently generate benefits for farmers and other stakeholders. In Lao PDR, the potential benefits of introduced technologies have not been fully realised by beneficiaries. We report on an analysis of a survey of 735 smallholder farmers in Southern Lao PDR who were questioned about factors that influenced their decisions to adopt new technologies. (...) In this study, we have constructed measures or states of adoption which identify key elements of an adoption decision-making nexus. Analysis was conducted to statistically group explanatory factors of adoption. The key explanatory factors represented attributes of the farmer, the factors considered when undertaking production decisions and elements of the agricultural value chain that present as opportunities or constraints. We describe the combination of farmer’s personal attributes, perceptions of the value chain, and the introduction of new technologies by external actors as an “agricultural research value chain”, where agricultural research activities intervene to derive greater benefits for local farmers. A generalised linear model, via Poisson regression analysis on the identified explanatory factors, was applied to explore how they influence adoption measures and we found several significant relationships. (shrink)

The most promising accounts of ontic probability include the Spielraum conception of probabilities, which can be traced back to J. von Kries and H. Poincaré, and the best system account by D. Lewis. This paper aims at comparing both accounts and at combining them to obtain the best of both worlds. The extensions of both Spielraum and best system probabilities do not coincide because the former only apply to systems with a special dynamics. Conversely, Spielraum probabilities may not be part (...) of the best system, e.g. if a broad class of random devices is not often used. Spielraum probabilities have the potential to provide illuminating explanations of frequencies with which outcomes of trials on gambling devices arise. They ultimately fail to account for such frequencies though because they are compatible with frequencies that grossly differ from the values of the respective probabilities. I thus follow recent proposals by M. Strevens and M. Abrams and strengthen the definition of Spielraum probabilities by adding a further condition that restricts some actual frequencies. The resulting account remains limited in scope, but stands objections raised against it in the recent literature: it is neither circular nor based upon arbitrary choices of a measure or of physical variables. Nor does it lack any explanatory power. (shrink)

Heterogeneous treatment effects represent a major issue for medicine as they undermine reliable inference and clinical decision-making. To overcome the issue, the current vision of precision and personalized medicine acknowledges the need to control individual variability in response to treatment. In this paper, we argue that gene-treatment-environment interactions (G × T × E) undermine inferences about individual treatment effects from the results of both genomics-based methodologies—such as genome-wide association studies (GWAS) and genome-wide interaction studies (GWIS)—and randomized controlled trials (RCTs). (...) Then, we argue that N-of-1 trials can be a solution to overcome difficulties in handling individual variability in treatment response. Although this type of trial has been suggested as a promising strategy to assess individual treatment effects, it nonetheless has limitations that limit its use in everyday clinical practice. We analyze the existing variability within the designs of N-of-1 trials in terms of a continuum where each design prioritizes epistemic and pragmatic considerations. We then support wider use of the designs located at the pragmatic end of the explanatory-pragmatic continuum. (shrink)

This paper sets forth a familiar theme, that science essentially consists of two interdependent episodes, one imaginative, the other critical. Hypotheses and other imaginative conjectures are the initial stage of scientific inquiry because they provide the incentive to seek the truth and a clue as to where to find it. But scientific conjectures must be subject to critical examination and empirical testing. There is a dialogue between the two episodes; observations made to test a hypothesis are the inspiration for new (...) conjectures. Inductive generalizations may also inspire hypotheses, but cannot validate them. A hypothesis is empirically tested by ascertaining whether or not predictions about the world of experience deduced from the hypothesis agree with what is actually observed. This has been appropriately considered the 'criterion of demarcation' that distinguishes science from other knowledge. But scientific hypotheses must satisfy other tests as well, e.g., whether they have explanatory value and further understanding. I briefly explore such issues as verifiability and falsifiability, empirical content and truthfulness, contingency and certainty, fact and theory, error and fraud. Science like any human activity is subject to error and to the foibles and other failings of human beings. But severe attempts of empirical falsification and other trials yield knowledge that stands the test of time and provides a foothold for further knowledge. Moreover, scientists have developed social mechanisms, such as peer review and publication, to evaluate their work. Because the research of scientists depends on the validity of previous knowledge, it is of great consequence that they discern valid from invalid knowledge and thus scientists are inclined to transcend ideology, nationality, friendship, monetary interest and other prejudices when the mettle of scientific knowledge is at stake. I use historical examples to illustrate some relevant aspects of scientific practice: its success (Mendel), misrepresentation (Darwin), ideological abuse (Lysenko), arrogant violation of the requirement of testing (Koch), theory replacement (Priestly and Lavoisier, Newton and Einstein), and the indispensability of context (Oswald Avery and Alfred Wegener). (shrink)

While the theory of relative plausibility is presented by Allen and Pardo as a descriptive theory of the proof process, this commentary discusses their theory as a possible starting point for a prescriptive theory of evidence assessment. Generally, naturalness and simplicity are necessary for the success of such a theory. The theory of relative plausibility is very promising in this respect, as its key concept is the straightforward and intuitive notion of explanation, according to which an explanation is an answer (...) to a “why” question. Still, both the explanatory and the comparative dimensions of relative plausibility are in need of elaboration if one wants to give advice on evidence assessment in terms of Allen and Pardo’s framework. For one thing, it is necessary to examine the epistemological status of the various explanatory criteria regarding their potential as guides to truth or likelihood. Only epistemic criteria should be included in recommendations to fact-finders. Moreover, given the author’s interpretation of the ‘beyond any reasonable doubt’ standard, it is unclear what the comparative dimension amounts to in criminal trials. At least a comparison of the kind involved in the author's account of civil trials standards is absent in their interpretation of BARD. If the comparative dimension of relative plausibility is relevant at all in criminal trials, it must be clarified what is to be compared. (shrink)

Previous research has demonstrated that judicial instructions are not well understood by jurors tasked with returning informative verdicts, and explanatory strategies can facilitate juror’s comprehension of law-related contents. Unlike a great deal of research on legal-lay interactions in a jury trial, most of which is based on English-language materials, the present article uncovers how Russian judges communicate law-related information to the jury. The study was motivated by the lack of guidance on interactions with the jury and the challenges faced (...) by the latter in attempting to understand technical concepts. Through quantitative and qualitative analyses of 18 jury instructions, the paper demonstrates that Russian judges work toward the achievement of a goal of recontextualizing law-related information and making legal concepts comprehensible to a lay audience using a wide repertoire of popularization tools, including definitions, descriptions, illustrations, paraphrases and metaphors. (shrink)

BackgroundMedical errors, unsatisfactory outcomes, or treatment complications often prompt patient complaints about healthcare providers. In response, physicians may adopt defensive practices to mitigate objections, avoid complaints, and navigate lengthy trial processes or other potential threats. However, such defensive medicine (DM) practices can carry risks, including potential harm to patients and the imposition of unnecessary costs on both patients and the healthcare system. Moreover, these practices may run counter to accepted ethical standards in medicine.MethodsThis qualitative study involved conducting semi-structured interviews with (...) 43 physicians, among whom 38 were faculty members at medical universities, 42 had administrative experience at various levels of the health system, and 23 had previously served as health system policymakers. On average, the participants had approximately 23.5 years of clinical experience. The selection of participants was based on purposive sampling. Data collection through interviews continued until data saturation was achieved.ResultsBased on the findings, DM manifests in both positive and negative forms, illustrated by instances like ordering unnecessary lab tests, imaging, or consultations, reluctance to admit high-risk patients, and avoiding high-risk procedures. The study participants identified a range of underlying and contextual factors contributing to DM, encompassing organizational-managerial, social, personal, and factors inherent to the nature of defensive medical practices. The results also highlight proposed strategies to address and prevent DM, which can be grouped into organizational-managerial, social, and those focused on modifying the medical complaints management system.ConclusionDM is a multifaceted and significant phenomenon that necessitates a comprehensive understanding of its various aspects, including interconnected and complex structures and underlying and contextual factors. While the results of this study offer a solid foundation for informing policy decisions within the healthcare system and include some explanatory policy suggestions, we encourage policymakers to complement the findings of this study with other available evidence to address any potential limitations and to gain a more comprehensive understanding of the policymaking process related to DM. (shrink)

Much is asked of the concept of chance. It has been thought to play various roles, some in tension with or even incompatible with others. Chance has been characterized negatively, as the absence of causation; yet also positively—the ancient Greek τυχη´ reifies it—as a cause of events that are not governed by laws of nature, or as a feature of the laws themselves. Chance events have been understood epistemically as those whose causes are unknown; yet also objectively as a distinct (...) ontological kind, sometimes called ‘pure’ chance events. Chance gives rise to individual unpredictability and disorder; yet it yields collective predictability and order—stable long-run statistics, and in the limit, aggregate behavior susceptible to precise mathematical theorems. Some authors believe that to posit chances is to abjure explanation; yet others think that chances are themselves explanatory. During the Enlightenment, talk of ‘chance’ was regarded as unscientific, unphilosophical, the stuff of superstition or ignorance; yet today it is often taken to be a fundamental notion of our most successful scientific theory, quantum mechanics, and a central concept of contemporary metaphysics. Chance has both negative and positive associations in daily life. The old word in English for it, hazard, which derives from French and originally from Arabic, still has unwelcome connotations of risk; ‘chance’ evokes uncertainty, uncontrollability, and chaos. Yet chance is also allied with luck, fortune, freedom from constraint, and diversity. And it apparently has various practical uses and benefits. It forms the basis of randomized trials in statistics, and of mixed strategies in decision theory and game theory; it is appealed to in order to resolve problems of fair division and other ethical.. (shrink)

Scott Waterman's reflection on his experience with chronic pain and alternative treatments raises a fundamental question in medical epistemology: How can we know that an intervention will help people who are suffering?Waterman's details his trial of an alternative therapy with a dubious pathophysiological rationale. Despite the lack of research demonstrating its efficacy, and a lack of therapeutic benefit for him in particular, he acknowledges its benefit to others who were more attitudinally predisposed to it. This leads him to conclude that (...) one's personal beliefs and explanatory hypotheses play a role in the healing process. From this he concludes that data from clinical studies conducted according to... (shrink)

In the final tablet of Ludlul bēl nēmeqi lines 42–53 Šubši-mešrê-Šakkan passes through twelve gates in or near the precincts of Marduk’s Esagila in Babylon. As the protagonist passes through these twelve gates he is symbolically rehabilitated and reintegrated into society, marking the end of his trials and the beginning of his Marduk-renewed life. One gate is named in each of the twelve lines. At each gate, identified in the first half of the line, the protagonist is granted something (...) positive, which is described in the second half of the line. In the present study I argue that the author of Ludlul derived the substance of what the sufferer received at each gate—and therefore the textual substance of the second half of each of these poetic lines—from the names of the gates themselves via the same kinds of learned scribal interpretive methods used in commentary and explanatory texts. That is, the author of Ludlul connected the names of the gates and the descriptions of what the sufferer received at each by way of applied translations of the Sumerian gate names, sound plays on the words and syllables comprising the names of the gates, graphic plays on the cuneiform signs with which the names are written, and in at least one case a mythological interpretation based on the gate’s name. (shrink)

The marketing of infant formula in third-world countries in the 1970s by Nestlé S.A. gave rise to a consumer boycott that came to be a widely taught case study in the field of Business Ethics. This article extends that case study by identifying three specific individuals who were associated with managing Nestlé’s response to that boycott. It reveals their subsequent direct involvement in a number of additional “classic” 1980s business scandals (some of which ended with major criminal trials and (...) the imprisonment of eminent business figures)—and describes tangential linkages to other business scandals of the time. The article discloses a behind-the-scenes pattern of business villainy, adding both depth and breadth to previous accounts of these scandals. The article offers a conceptual framework that goes beyond personal greed as an explanatory factor for such unethical behavior in the business world, suggesting the presence of personal and organizational networks of intrigue and opportunity. The linkages between the scandals suggest an epidemiological process with the plotters acting as “virus” carriers contaminating various corporate cultures. (shrink)

Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the results (...) of an examination of eligibility criteria in two sets of clinical trials, one sponsored by the NSABP, the other sponsored by POG, covering a twenty-year time span are presented. The POG trials had far fewer eligibility criteria than the NSABP studies, suggesting that large numbers of criteria may not be necessary for high quality research. In the third chapter, the impact of subjective eligibility criteria on enrollment and investigator uncertainty is explored. Subjective criteria were associated with more variable enrollment decisions and greater uncertainty. Such criteria represent a threat to the validity, conduct and interpretation of trials and, therefore, should only be included when carefully justified. The fourth chapter examines the accuracy of the reporting of eligibility criteria in sets of corresponding study protocol, methods paper, journal article, and Clinical Alert. Important information is lost at each step in the dissemination of study results. Unnecessary criteria ought to be dropped at a trial's inception; all other criteria must be reported faithfully. The fifth chapter attempts to provide a comprehensive philosophical account of just selection procedures for clinical research using the political philosophy of Michael Walzer. The sixth, and last, chapter, discusses explanatory and pragmatic approaches to clinical trial design, overlapping scientific and ethical concerns related to eligibility criteria, and questions for further study. (shrink)

The present paper describes a joint action paradigm in which individuals or pairs utilized two computer keys to keep a dot stimulus moving inside a larger rectangle. Members of a pair could neither see nor hear each other. This paradigm allowed us to combine the discrete-trial type dependent variables commonly utilized by representational theorists, with the continuous, temporal dependence variables utilized by dynamical theorists. Analysis revealed that individuals kept the dot in the rectangle longer than dyads and did so by (...) moving it back and forth within the rectangle. Dyads, however, pressed their individual buttons as quickly as possible in order to keep the dot near the middle of the rectangle. These findings indicate that joint action constitutes a multi-scale phenomena that is best investigated via multiple, complementary methodologies versus single-measure, competing theories. (shrink)

The authors of this collection fail to make clear the distinction between naturalistic and purely logical/methodological approaches to the philosophy of science. I also criticise Thomas Nickles's attempt to devise an explanatory method for discovery in science using programs that produce trial and error explorations of a domain, which he thinks replaces the need for a conjecture a refutation approach (cf. Popper and Campbell). Such programs embody undeclared conjectures in the way they are set up.

Abstract: This paper argues that a central explanatory role for the concept of Umwelt in theoretical biology is to be found in developmental biology, in particular in the effort to understand development as a goal-directed and adaptive process that is controlled by the organism itself. I will reach this conclusion in two (interrelated) ways. The first is purely theoretical and relates to the current scenario in the philosophy of biology. Challenging neo-Darwinism requires a new understanding of the various components (...) involved in natural selection processes. An important prerequisite for the explanation is the ability to understand development in a teleological way. Here, the concept of Umwelt plays a crucial role: if organisms are responsible for generating adaptive variation in specific environments, we need a theory that explains the context-dependent nature of adaptively oriented processes. The Umwelt is thus a central element in determining the goal that an adaptive process pursues. The second path in my analysis also has a historical dimension. I will present Karl Ernst von Baer’s reflections on teleological development and his influence on von Uexküll's thinking. I will present various ideas developed by von Baer, such as the distinction between Ziel and Zweck and the use of musical metaphors, which can help to understand development teleologically and give von Uexküll’s theory a central place in this framework. (shrink)

There are several important arguments in metaethics that rely on explanatory considerations. Gilbert Harman has presented a challenge to the existence of moral facts that depends on the claim that the best explanation of our moral beliefs does not involve moral facts. The Reliability Challenge against moral realism depends on the claim that moral realism is incompatible with there being a satisfying explanation of our reliability about moral truths. The purpose of this chapter is to examine these and related (...) arguments. In particular, this chapter will discuss four kinds of arguments – Harman’s Challenge, evolutionary debunking arguments, irrelevant influence arguments, and the Reliability Challenge – understood as arguments against moral realism. The main goals of this chapter are (i) to articulate the strongest version of these arguments; (ii) to present and assess the central epistemological principles underlying these arguments; and (iii) to determine what a realist would have to do to adequately respond to these arguments. (shrink)

Both philosophers and psychologists have argued for the existence of distinct kinds of explanations, including teleological explanations that cite functions or goals, and mechanistic explanations that cite causal mechanisms. Theories of causation, in contrast, have generally been unitary, with dominant theories focusing either on counterfactual dependence or on physical connections. This paper argues that both approaches to causation are psychologically real, with different modes of explanation promoting judgments more or less consistent with each approach. Two sets of experiments isolate the (...) contributions of counterfactual dependence and physical connections in causal ascriptions involving events with people, artifacts, or biological traits, and manipulate whether the events are construed teleologically or mechanistically. The findings suggest that when events are construed teleologically, causal ascriptions are sensitive to counterfactual dependence and relatively insensitive to the presence of physical connections, but when events are construed mechanistically, causal ascriptions are sensitive to both counterfactual dependence and physical connections. The conclusion introduces an account of causation, an "exportable dependence theory," that provides a way to understand the contributions of physical connections and teleology in terms of the functions of causal ascriptions. (shrink)

The official model of explanation proposed by the logical empiricists, the covering law model, is subject to familiar objections. The goal of the present paper is to explore an unofficial view of explanation which logical empiricists have sometimes suggested, the view of explanation as unification. I try to show that this view can be developed so as to provide insight into major episodes in the history of science, and that it can overcome some of the most serious difficulties besetting the (...) covering law model. (shrink)

Interpretation -- Introduction -- Interpreting Plato -- The political culture of Plato's early dialogues -- Dialogue -- Character and history -- The mouthpiece principle -- Forms of evidence -- Desire -- Socrates and eros -- The subjectivist conception of desire -- Instrumental and terminal desire -- Rational and irrational desires -- Desire in the critique of Akrasia -- Interpreting Lysis -- The deficiency conception of desire -- Inauthentic friendship -- Platonic desire -- Antiphilosophical desires -- Knowledge -- Excellence as wisdom (...) -- The epistemic unity of excellence -- Dunamis and technê -- Goodness and form -- The epistemological priority of definitional knowledge -- Ordinary ethical knowledge -- Method -- The Socratic fallacy -- Socrates' pursuit of definitions -- Hupothesis -- Two postulates -- The geometrical illustration -- Geometrical analysis -- The method of reasoning from a postulate -- Elenchus and hupothesis -- Knowledge and aitia -- F-conditions -- Cognitive security -- Aporia -- Forms of aporia -- Dramatic aporia -- The example of Charmides -- Charmides as autobiography -- The politics of Sôphrosunê -- Critias' Philotimia -- Self-knowledge and the knowledge of knowledge -- Knowledge of knowledge and knowledge of the good -- Philosophy and the polis. (shrink)

Explanatory Optimism about the Hard Problem of Consciousness argues that despite the worries of explanatory pessimists, consciousness can be fully explained in “easy” scientific terms. The widespread intuition that consciousness poses a hard problem is plausibly based on how consciousness appears to us in first-person access. The book offers a debunking argument to undercut the justificatory link between the first-person appearances and our hard problem intuitions. -/- The key step in the debunking argument involves the development and defense (...) of an empirical model of first-person access: Automated Compression Theory (ACT). ACT holds that first-person access to consciousness is accomplished by automated accessing of compressed sensory information. Because of the distorting nature of this compressed access, it seems to subjects that consciousness possesses “exceptional” properties—properties leading to the hard problem—even though no such properties are present. If there are no exceptional properties to explain, then an explanation in easy terms can fully account for conscious experience. The book presents a range of empirical evidence for ACT and concludes that the burden of proof is now on the pessimists to show why we shouldn’t be optimistic about explaining consciousness. (shrink)