Many children and adults experience significant breakdown in the use of language. The resulting pragmatic disorders present a considerable barrier to effective communication. This book is the first critical examination of the current state of our knowledge of pragmatic disorders and provides a comprehensive overview of the main concepts and theories in pragmatics. It examines the full range of pragmatic disorders that occur in children and adults and discusses how they are assessed and treated by clinicians. Louise Cummings attempts (...) to integrate the fields of pragmatics, language pathology and cognitive science by examining the ways in which pragmatics can make a useful contribution to debates about cognitive theories of autism. The reader is encouraged to think in a critical fashion about how clinicians, experimentalists and theorists deal with pragmatic issues. (shrink)

This paper aims to show how clinical pragmatics can fruitfully inform the classical theoretical models proposed by philosophical pragmatics. In the first part of the paper I argue that theories proposed in the domain of philosophical pragmatics, as those elaborated by Austin and Grice, are not plausible from a cognitive point of view and that for this reason they cannot be useful to understand pragmatic deficits. In the second part, I show that Relevance Theory overcomes this (...) limitation, but I also argue that it offers a restricted view of human communication which has to be integrated with a model of language use that takes into account a central pragmatic property: coherence of discourse. (shrink)

The study of pragmatic disorders is of interest to speech-language pathologists who have a professional responsibility to assess and treat communication impairments. However, these disorders, it will be argued in this paper, have a significance beyond the clinical management of clients with communication impairments. Specifically, pragmatic disorders can now make a contribution to the diagnosis of a range of clinical conditions in which communication is adversely affected. These conditions include attention deficit hyperactivity disorder, the autistic spectrum disorders, schizophrenia (...) and the dementias. Pragmatic disorders are already among the criteria used to diagnose some of these conditions, although they are not described in these terms. In other conditions, pragmatic disorders have potential diagnostic value in the absence of reliable biomarkers of these conditions and similar initial presenting symptoms. Using clinical data, and the findings of empirical studies, the case is made for the inclusion and/or greater integration of pragmatic disorders in the formal classificatory systems that are used to diagnose a range of disorders. A previously unrecognised role for pragmatic impairments in the nosology and diagnosis of clinical disorders is thereby established. (shrink)

The cognitive basis of utterance interpretation is an area that continues to provoke intense theoretical debate among pragmatists. That utterance interpretation involves some type of mind-reading or theory of mind (ToM) is indisputable. However, theorists are divided on the exact nature of this ToM-based mechanism. In this paper, it is argued that the only type of ToM-based mechanism that can adequately represent the cognitive basis of utterance interpretation is one which reflects the rational, intentional, holistic character of interpretation. Such a (...) ToM-based mechanism is supported on conceptual and empirical grounds. Empirical support for this view derives from the study of children and adults with pragmatic disorders. Specifically, three types of clinical case are considered. In the first case, evidence is advanced which indicates that individuals with pragmatic disorders exhibit deficits in reasoning and the use of inferences. These deficits compromise the ability of children and adults with pragmatic disorders to comply with the rational dimension of utterance interpretation. In the second case, evidence is presented which suggests that subjects with pragmatic disorders struggle with the intentional dimension of utterance interpretation. This dimension extends beyond the recognition of communicative intentions to include the attribution of a range of cognitive and affective mental states that play a role in utterance interpretation. In the third case, evidence is presented that children and adults with pragmatic disorders struggle with the holistic character of utterance interpretation. This serves to distort the contexts in which utterances are processed for their implicated meanings. The paper concludes with some thoughts about the role of theorizing in relation to utterance interpretation. (shrink)

Identifying which subjects are vulnerable, and implementing safeguards to protect them, is widely regarded as essential to clinical research. Commentators have endorsed a number of responses to these challenges and have thereby made significant progress in understanding vulnerability in clinical research. At the same time, this literature points to a central contradiction which calls into question its potential to protect vulnerable subjects in practice. Specifically, analysis suggests that all human subjects are vulnerable and vulnerability in clinical research (...) is comparative and context dependent, in the sense that individuals are vulnerable relative to others and in some contexts only. Yet, if everyone is vulnerable, there seems to be no point in citing the vulnerability of some individuals. Moreover, the conclusion that everyone is vulnerable seems inconsistent with the claims that vulnerability is comparative and context dependent, raising concern over whether it will be possible to develop a comprehensive account of vulnerability that is internally consistent. The solution to this dilemma lies in recognition of the fact that the practical significance of claims regarding vulnerability depends on the context in which they are used. The claims that appear to lead to the central contradiction are in fact accurate conclusions that follow from different uses of the term ‘vulnerability’. The present manuscript describes this ‘pragmatic’ approach to vulnerability in clinical research and considers its implications for ensuring that subjects receive appropriate protection. (shrink)

Pragmatic clinical trials are a relatively new methodological approach to the execution of clinical research that can increase research efficiency and provide access to unique data. Some have suggested that the costs and delays associated with obtaining informed consent could make PCTs difficult or even impossible to execute. Alternative consent models have been proposed, some of which lower standards of disclosure, delay consent, or waive it altogether. We analyze the permissibility of changes to informed consent in the context (...) of Canadian research ethics policies, legislation, common law, professional codes of ethics, and professional standards of practice. We find that Canadian law and policy relating to informed consent clearly applies to any clinician who might be involved in a PCT. In addition, existing consent norms seem unable to accommodate alternative consent models for pragmatic research if such models would involve lowering the standard of disclosure. The strong emphasis on the primacy... (shrink)

Pragmatic clinical trials (PCTs) seek to show the effectiveness of treatments in routine, clinical practice (MacPherson 2004). However, a number of ethical challenges come to the fore when collater...

It was the spring of 2020 when the email came to our inboxes—a memo from our Institutional Review Board informing us that we were approved to begin conducting our pragmatic clinical trial with a wa...

The target articles in this issue advance our understanding of bioethical considerations in pragmatic trials (Garland, Morain, and Sugarman 2023; Morain and Largent 2023). Both articles appreciate...

Both Morain and Largent (2023) and Garland, Morain, and Sugarman (2023) recognize the ethical challenges inherent in clinician participation in embedded research. Focusing on the question of integr...

Garland, Morain, and Sugarman (2023) can be congratulated for their comprehensive and sharp analysis of physicians’ ethical duties with respect to pragmatic clinical trials (PCTs). PCTs embed resea...

Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out of this research (...) must justify their refusal. Reasons to refuse include that the trial is badly designed in some way, that the trial activities will violate the clinician’s conscience, or that the trial will impose excessive burdens on the clinician. (shrink)

Well-designed pragmatic clinical trials (PCTs) are critical for improving healthcare delivery and patient outcomes (Haff and Choudhry 2018), and the article written by Garland et al. (2023) advance...

Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial (...) collateral findings,? or?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice. (shrink)

Definiton of the problem: The current literature concerning the topic of ”informed consent” confronts physicians with a growing demand for extended and sophisticated disclosure duties. Often enough they hardly seem to be feasible, not least because of an actual lack of personnel and time. The problem is to find a realisable way to balance these theoretical and practical considerations. Arguments: The fundamental idea of the concept presented here consists of using the difficulty of a certain decision as standard for determining (...) the required extent of the patient’s actual decisional autonomy. As the prominent aspect of this difficulty of decision-making, the occurrence of conflicting values – termed ”value concurrence”– is identified. Conclusion: Structuring physician-patient-communication in accordance with this ”value-concurrence” should prove to be applicable in the clinical context without neglecting important ethical reflections. (shrink)

Although moral case deliberation (MCD) is evaluated positively as a form of clinical ethics support (CES), it has limitations. To address these limitations our research objective was to develop a thematic CES tool. In order to assess the philosophical characteristics of a CES tool based on MCDs, we drew on hermeneutic ethics and pragmatism. We distinguished four core characteristics of a CES tool: (a) focusing on an actual situation that is experienced as morally challenging by the user; (b) stimulating (...) moral inquiry into the moral concepts, questions and routines in the lived experience of the CES tool user; (c) stimulating moral learning by exploring other perspectives; and (d) incorporating contextual details. We provide an example of a CES tool developed for moral dilemmas over client autonomy. Our article ends with some reflections on the normativity of the CES tool, other application areas and the importance of evaluation studies of CES tools. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 9-17, May–June 2022.

We very much appreciate the helpful and generous commentaries in response to “Do Clinicians have a Duty to Participate in Pragmatic Clinical Trials?” (Garland, Morain, and Sugarman 2023). In that a...

In their thoughtful and well-supported target article, Andrew Garland, Stephanie Morain, Jeremy Sugarman (2023) argue that clinicians have a duty to participate in pragmatic clinical trials. This d...

_341_ _Objectives: _In patients with multivessel disease both the detection of the culprit lesion and the exact allocation are important preconditions for sufficient treatment and improved outcome. In a vessel based approach the combination of quantitative coronary angiography and fractional flow reserve measured by a pressure wire should be advantageous compared to myocardial SPECT, as morphological and functional information is delivered simultaneously. Therefore our aim was to evaluate MS in the detection and allocation of hemodynamically significant stenoses obtained by the (...) combined gold standard QCA plus FFR in patients with multivessel disease. _Methods: _FFR and QCA of 95 vessels in 80 patients have been evaluated. Hemodynamically significant target lesions were defined as intermediate stenoses between 50 and 75% with an FFR. (shrink)

Morain and Largent’s (2023) thorough and thoughtful article concludes that the partial-entrustment model of medical researchers’ ancillary-care obligations (Richardson and Belsky 2004; Belsky and R...

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)

Pragmatic approaches to genetic testing are discussed and appraised. Whilst there are various schools of pragmatism, the Deweyan appraoch seems to be the most appreciated in bioethics as it allows a historical approach indebted to Hegel. This in turn allows the pragmatist to specify and balance principles in various contexts. There are problems with where to draw a line between what is referred to here as the micro- and macro-level of doing bioethics, unless one is simply to be classified as (...) a principlist. Whilst most discussions on genetics occur at a macro level, most specifying must be done also at a micro level – the clinical encounter. Whilst pragmatism encourages us to understand better social and scientific factors and puts into perspective statements like ‘playing God’, doubts are raised about the ‘consensus’ process and how one can put aside fundamental values such as the moral status of the embryo on which there is general disagreement. If those doing pragmatism do not endorse these values, there seems to be little ground for process and compromise with those who do. It seems therefore that pragmatism cannot ignore values, even those which are not endorsed by everyone. (shrink)

To precisely define wisdom has been an ongoing task of philosophers for millennia. Investigations into the psychological dimensions of wisdom have revealed several features that make exemplary persons “wise.” Contemporary bioethicists took up this concept as they retrieved and adapted Aristotle’s intellectual virtue of phronesis for applications in medical contexts. In this article, we build on scholarship in both psychology and medical ethics by providing an account of clinical wisdom qua phronesis in the context of the practice of psychoanalysis (...) and psychodynamic psychotherapy. With the support of qualitative data, we argue that the concept of clinical wisdom in mental healthcare shares several of the key ethical dimensions offered by standard models of phronesis in medical ethics and serves as a useful, albeit overlooked, reference point for a broader development of virtue-based medical ethics. We propose that the features of clinical wisdom are pragmatic skills that include, but are not limited to, an awareness of balance, the acceptance of paradox, and a particular clinical manner that maintains a deep regard for the Other. We offer several suggestions for refining training programs and redoubling efforts to provide long-term mentorship opportunities for trainees in clinical mental healthcare in order to cultivate clinical wisdom. (shrink)

: "Clinical pragmatism" is an important new method of moral problem solving in clinical practice. This method draws on the pragmatic philosophy of John Dewey and recommends an experimental approach to solving moral problems in clinical practice. Although the method may shed some light on how clinicians and their patients ought to interact when moral problems are at hand, it nonetheless is deficient in a number of respects. Clinical pragmatism fails to explain adequately how moral problems (...) can be solved experimentally, it underestimates the relevance and importance of judgment in clinical ethics, and it presents a questionable account of the role that moral principles should play in moral problem solving. (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)

Pragmatic disorders in children and adults have been the focus of clinical investigations for approximately 40 years. In that time, clinicians and researchers have established a diverse range of pragmatic phenomena that are disrupted in these disorders. Pragmatic deficits include problems with the use and understanding of speech acts, the processing of non-literal language, failure to adhere to Gricean maxims in conversation and discourse deficits. These deficits are found in several clinical populations including individuals with autistic spectrum disorders, (...) schizophrenia, traumatic brain injury and right-hemisphere damage. However, what is less often investigated is the social impact of pragmatic disorders on the children and adults who are affected by them. In this paper, I examine what is known about pragmatic disorders in these clinical groups. I then consider the wider social consequences of these disorders, where consequences are broadly construed to include factors that act as indicators of social adjustment. (shrink)

A traditional approach to teaching medical ethics aims to provide knowledge about ethics. This is in line with an epistemological view on ethics in which moral expertise is assumed to be located in theoretical knowledge and not in the moral experience of healthcare professionals. The aim of this paper is to present an alternative, contextual approach to teaching ethics, which is grounded in a pragmatic-hermeneutical and dialogical ethics. This approach is called moral case deliberation. Within moral case deliberation, healthcare professionals (...) bring in their actual moral questions during a structured dialogue. The ethicist facilitates the learning process by using various conversation methods in order to find answers to the case and to develop moral competencies. The case deliberations are not unique events, but are a structural part of the professional training on the work floor within healthcare institutions. This article presents the underlying theory on ethics and illustrates this approach with an example of a moral case deliberation project in a Dutch psychiatric hospital. The project was evaluated using the method of responsive evaluation. This method provided us with rich information about the implementation process and effects the research process itself also lent support to the process of implementation. (shrink)

In this provocative contribution to both psychoanalytic theory and the philosophy of science, Louis Berger grapples with the nature of "consequential" theorizing, i.e., theorizing that is relevant to what transpires in clinical practice. By examining analysis as a genre of "state process formalism" - the standard format of scientific theories - Berger demonstrates why contemporary theorizing inevitably fails to explain crucial aspects of practice. His critique, in this respect, pertains both to the formal structure of psychoanalytic explanation and the (...) technical language through which this structure gains expression. The pragmatic recommendations that issue from this critique are illustrated with respect to a number of perennial problem areas besetting analysis and cognate disciplines. In a discussion that encompases theories of affect, issues in family therapy, the nature of first-language acquisition, and the philisophical topics of free will and determinism, Berger shows that certain systems of representation _can_ describe the psychological realm adequately, and that such systems necessarily follow modern physics in rejecting naive assumptions about the separability of theory and practice. His proposals culminate in a "nonhierarchical" conception of psychoanalytic theory that assigns a separate status to the clinically pragmatic level of theorizing. In both his critique of contemporary analysis and his reconstructive proposals, Berger fuses into a highly readable argument a fascinating range of insights culled from epistemology, linguistics, physics, logic, computer science, history, and aesthetics. More impressively still, he demonstrates how an investigation of psychoanalytic theory can serve as a vehicle for examining pervasive epistemological issues in both philosophy and the social sciences. (shrink)

This unique volume explores what ethics has to offer the practicing physician, nurse, and allied health care worker. The authors introduce the basic vocabulary of ethics and present and discuss the most commonly used ethical theories, using case studies to illustrate how ethics work within the context of health care. Newcomers to the field will learn what ethics is all about and how it relates to the pragmatic concerns of the health care professional. Those who already have a working knowledge (...) of the field will find a new approach to ethical theory--personalism--which the authors believe can make the practical use of ethics more effective and reliable. (shrink)

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking (...) about therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: the specification of exceptional circumstances, the specification of unproven interventions, the goals of interventional research in terms of individual versus collective interests, the place of adaptive trial designs and the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy, Psychiatry, & Psychology 10.1 (2003) 63-66 [Access article in PDF] The Pragmatics of Psychiatry and the Psychiatry of Cross-Cultural Suffering Jennifer Radden I AM IN SUBSTANTIAL AGREEMENT with many of the conclusions David Brendel draws in his thoughtful discussion. Misleading language aside, I particularly applaud his use of my plea for ontological descriptivism to support clinical practice, which respects, as he puts it, the subjectively "melancholic" (...) person living behind the objectively "depressed" clinical presentation.Brendel offers two main critiques of my discussion about the relationship between today's depression and melancholia of past eras. First, he asserts that I neglect the relevance of causal reasoning in my preference for a descriptivist over a causal ontology. Second, arguing that pragmatic considerations ought to be, as he says, front and center when philosophers and psychiatrists "grapple with the complexities of psychiatric explanation," (Brendel 2003, 54) he questions what he sees as my too ready dismissal of pragmatism in this discussion. Allegiance to pragmatism seems to me to sit strangely with support for a causal ontology, as I shall try to demonstrate. But first let me comment on these two sides of Brendel's commentary.The case of Van Gogh's alleged melancholia is particularly well chosen because there has been continuing debate about Van Gogh's condition, including scholarly work attributing it to an inherited metabolic disorder (Arnold 1992). Brendel's suggestion that a causal ontology might allow us to use historical evidence to throw light on the relation between depression and melancholia is an interesting and fruitful one that I had overlooked. Brendel also holds hope for drug cartography as a means of determining the causes of mental disorders. I admit to the initial plausibility of the approach to classification employed by drug cartography, of course. Diagnostic maps must be evaluated according to their effectiveness for the purposes they serve, and cannot—or should not—be seen as mere descriptions of natural phenomena. And maps based on psychopharmacological effects will serve one of the most important purposes we can have in relation to mental disorders: their successful treatment. Nonetheless, as I indicated in my essay, there are conceptual limitations to drug cartography. That several different syndromes respond to the same drug is suggestive, but it does not tell us anything definitive about structural similarities or differences between those different disorders. Nor, from the fact that a condition is alleviated by drugs, does it follow that a particular brain state was the initiating cause of that condition.My dismissal of a pragmatic approach in the foregoing discussion may have been overly hasty. [End Page 63] But in trying to make good this omission, I find myself struck by the complexity of the task. There appear to be at least five different places where a pragmatic response might be called for: (1) in deciding what to say about the relationship between depression and melancholia; (2) in determining the structure of any given psychiatric classification; (3) in choosing between what I have called descriptivist and causal ontologies; (4) in electing a course or method of treatment in the clinical context; and (5) in evaluating psychiatric explanations.With regard to (1), I have sketched in a note one pragmatic consideration in favor of equating melancholia and depression: by so doing, we might reinvest depressive states with some of the glamorous associations from the past and so diminish the stigma and provide some compensation and consolation for the suffering attaching to depression. Pragmatic reasoning may be perfectly appropriate here. I beg to point out that pragmatic considerations let me neglect it.With regard to (2), I recognize that psychiatric classifications are not so much identifications of natural kinds as responses to our various purposes; indeed, this point is offered as one drawback of adopting a causal analysis, because there is little reason to expect our purposes, which are a product of culture, to correspond to natural arrangements, which are not.With regard to (3), if there were overriding pragmatic considerations that favored accepting one or the other of these ontologies, then perhaps this would be... (shrink)

This book explores new territory at the interface between semantics and pragmatics, reassessing a number of linguistic phenomena in the light of recent advances in pragmatic theory and presenting stimulating insights by experts in linguistics and philosophy. The authors begin by reassessing the definition of four theoretical concepts: saturation, free pragmatic enrichment, completion and expansion. They go on to confront disciplines that have addressed similar issues but that have not necessarily been in close contact, and then turn to questions (...) related to reported speech, modality, indirect requests and prosody. Chapters investigate lexical pragmatics and lexical semantics and other interactions involving experimental pragmatics, construction grammar, clinical linguistics, and the distinction between mental and linguistic content. The authors bridge the gap between different disciplines, subdisciplines and methodologies, supporting cross-fertilization of ideas and indicating the empirical studies that are needed to test current theoretical concepts and push the theory further. Readers will find overviews of the ways in which concepts are defined, empirical data with which they are illustrated and explorations of the theoretical frameworks in which concepts are couched. This exciting exchange of ideas has its origins in the editors’ workshop series on the theme ‘The semantics/pragmatics interface: linguistic, logical and philosophical perspectives’, held at the University of Lille 3 in 2012-13. Scholars of linguistics, logic and philosophy and those interested in the research benefits of crossing disciplines will find this work both accessible and thought-provoking, especially those with an interest in pragmatic theory or semantics. (shrink)

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking (...) about therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: the specification of exceptional circumstances, the specification of unproven interventions, the goals of interventional research in terms of individual versus collective interests, the place of adaptive trial designs and the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy, Psychiatry, & Psychology 10.1 (2003) 53-55 [Access article in PDF] A Pragmatic Consideration of the Relation between Depression and Melancholia David H. Brendel THE MELANCHOLIA OF THE PAST and the major depression of the present are extraordinarily complex notions that represent different things to different people. With her compelling article "Is This Dame Melancholy? Equating Today's Depression and Past Melancholia," Jennifer Radden makes an important contribution to the (...) debate on whether these concepts are identical, overlapping, or distinct. Exploring both conditions from descriptive and causal points of view, Radden appropriately concludes that fully equating the two of them would constitute a "troubling oversimplification." Her line of reasoning runs as follows. Because past descriptions of melancholia and current descriptions of major depression are marked by dissimilarities (such as the genius and creativity associated with the former and the self-loathing and emphasis on loss associated with the latter), only an underlying causal base common to both conditions would justify our equating them. But the cause (or causes) of melancholia and depression remain mysterious. Thus, although Radden acknowledges that a causal explanation might yield substantial benefits ("research possibilities, further hypotheses, and even hope of prevention, or cure"), she suggests that we remain in a descriptive mode when comparing the two conditions and conclude that they are not one and the same.Radden's argument that past melancholia and contemporary depression are descriptively distinct is convincing and, I think, indisputable. But I would like to challenge and expand upon some of her ideas about considerations of causality and about the role of pragmatic reasoning in working out the relation between melancholia and depression. First of all, although Radden is correct that the cause of many (or perhaps most) depressive states is unknown, she underrates the extent of the empirical knowledge that we have acquired about the causation of depression and, in so doing, undervalues the relevance of causal reasoning to making the melancholia/depression distinction. Recent empirical research has revealed that major depressive episodes can result from brain lesions such as left-sided strokes or metabolic disorders such as hypothyroidism (Yudofsky and Hales 2002). Psychosocial research, moreover, has suggested that stressful life events also can be understood as causes of depression (Kendler, [End Page 53] Karkowski, and Prescott 1999). These findings provide some hope that the identification of causes of various clinical states is a real possibility. Identification of such causes, I believe, could empower us to make some plausible claims about the similarities or differences between past melancholia and current depression. A melancholic individual like van Gogh, for example, had a different illness than a contemporary stroke patient with major depression in a present-day hospital, not only on the basis of descriptive distinctions between their conditions, but also on the basis of the causes of their respective states. Although of course we cannot know the cause of van Gogh's melancholia, we can reasonably assume that it was not the result of a left-sided stroke due to the absence in his case of other clinical deficits that usually result from such a stroke (such as language and motor deficits). Plausible assertions about the causes of melancholic and depressive states would add to the robustness of any claims regarding the distinctness of the conditions.Conversely, careful consideration of the etiology of various clinical presentations might prompt us to hypothesize a shared pathophysiology and thereby lead us to believe that they are essentially identical conditions. It is difficult or impossible to discover a cause of melancholia in individuals who lived in past eras. But we might achieve our goal by comparing well-defined major depression to various forms of what Radden calls "masked depression," such as those seen in cross-cultural settings, where the subjective symptoms of sad mood are absent but numerous somatic signs of depression are observed. If it turned out that major depression and masked depression had the same cause, then differences in their clinical phenomenology would become merely surface differences that belie a shared etiological process. How might one discover the existence of such a process... (shrink)

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors (...) then negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. (shrink)

Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified (...) four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs. (shrink)

The study of the cognitive substrates of pragmatic disorders is a relatively recent development in clinical pragmatics. This development has been ushered in by calls from researchers and clinicians on two fronts. First, it has been urged that the field of pragmatics should undergo a cognitive turn, such that a cognitive examination of pragmatic concepts is afforded equal significance to societal, philosophical and linguistic approaches to the discipline. Second, clinicians have increasingly acknowledged that it is not possible (...) to assess and treat clients with pragmatic disorders in isolation from cognitive concerns. The chapter begins with an examination of the various cognitive processes that play a role in a standard communicative exchange. From this examination the two main components of any cognitive treatment of pragmatic disorders—executive functions and theory of mind—are established. The findings of clinical studies of clients with pragmatic disorders are discussed. These studies suggest an association between cognitive processes such as theory of mind on the one hand and a range of pragmatic impairments on the other hand. Conversational data from clients with pragmatic disorders are used to illustrate these cognitive-based pragmatic impairments. Finally, three theoretical frameworks with the potential to explain the cognitive basis of pragmatic disorders are examined. (shrink)

Ethics committees are the most important practical instrument of clinical ethics in Belgium and fulfil three tasks: the ethical review of experimental protocols, advising on the ethical aspects of healthcare practice, and ethics consultation. In this article the authors examine the current situation of ethics committees in Belgium from the perspective of clinical ethics. Firstly, the most important steps which thus far have been taken in Belgium are examined. Secondly, recent opinion by the Belgian Advisory Committee on Bioethics (...) with regard to ethics committees is presented and the activities of Belgian ethics committees are discussed. Finally, the option to bring research ethics and clinical ethics under the roof of just one committee is criticised using a pragmatic and a methodological argument. Concomitantly, the authors build an argument in favour of the further development of ethics consultation. (shrink)

Objectives—To evaluate a departmental computer system.Design—a. Direct comparison of the time taken to use a manual system with the time taken to use a computer system for lung function evaluation, loan of equipment and production of correspondence. b. Analysis of the accuracy of data capture before and after the introduction of the computer system. c. Analysis of the comparative running costs of the manual and computer systems.Setting—Within a department of respiratory medicine serving a hospital of 1323 beds.Main Outcome Measures—a. Time (...) taken to perform functions with the assistance of computerised methods, in comparison to the manual method used alone. b. Accuracy of data capture. c. Relative running costs.Results—a. The computer system (CS) was significantly faster than the manual system (MS) for lung function evaluation (CS=7.63 min/test, MS=12.25 min/test), loan of equipment (CS=0.40 min/loan, MS=2.07 min/loan), and checking for overdue equipment (CS=0.49 s/record, MS=9 s/record). The production of correspondence was slightly slower with the computer (CS=9.30 min/letter, MS=8.54 min/letter). b. All outpatient episodes, but only 43 of 65 (66%) of inpatient episodes, were captured. Lung function and managerial report data were accurate using both manual and computerised methods. The manual system for equipment loans was inefficient, and use of the computer resulted in the recovery of 221 nebulisers. c. Development costs for 1988–1990 were high (£72 178). Only £1200 to £1845 per year was recovered directly from staff time saved by the computer but larger savings resulted from changes in work practice (£4049–4765). After 10 years the projected deficit is £10 000 per annum in running costs.Conclusions—In comparison with the manual methods, the computer system has shown significant advantages which provide accurate information, with significant favourable effects on working practices. In evaluating computer systems used in clinical practice it is essential to ensure that the projected work practice benefits are achieved without unacceptable costs in staff time, inaccurate data and high financial outlay. (shrink)

Objectives—To evaluate a departmental computer system.Design—a. Direct comparison of the time taken to use a manual system with the time taken to use a computer system for lung function evaluation, loan of equipment and production of correspondence. b. Analysis of the accuracy of data capture before and after the introduction of the computer system. c. Analysis of the comparative running costs of the manual and computer systems.Setting—Within a department of respiratory medicine serving a hospital of 1323 beds.Main Outcome Measures—a. Time (...) taken to perform functions with the assistance of computerised methods, in comparison to the manual method used alone. b. Accuracy of data capture. c. Relative running costs.Results—a. The computer system was significantly faster than the manual system for lung function evaluation, loan of equipment, and checking for overdue equipment. The production of correspondence was slightly slower with the computer. b. All outpatient episodes, but only 43 of 65 of inpatient episodes, were captured. Lung function and managerial report data were accurate using both manual and computerised methods. The manual system for equipment loans was inefficient, and use of the computer resulted in the recovery of 221 nebulisers. c. Development costs for 1988–1990 were high. Only £1200 to £1845 per year was recovered directly from staff time saved by the computer but larger savings resulted from changes in work practice. After 10 years the projected deficit is £10 000 per annum in running costs.Conclusions—In comparison with the manual methods, the computer system has shown significant advantages which provide accurate information, with significant favourable effects on working practices. In evaluating computer systems used in clinical practice it is essential to ensure that the projected work practice benefits are achieved without unacceptable costs in staff time, inaccurate data and high financial outlay. (shrink)

Outpatient services are increasingly recognised as an important component of health care provision and may be improved through the application of modern management techniques. We have performed a time and role audit of consultation and waiting times in two medical clinics using different queuing systems: namely, a serial processing clinic where patients wait in a single queue and a quasi-parallel processing clinic where patients are directed to the shortest queue to maintain clinic flow. Data collected were used to construct a (...) computer simulation of patient flows in clinic. Assessment of patient satisfaction in the clinic process was determined using a self-administered questionnaire. Mean waiting time was shorter in the quasi-parallel processing clinic: 26 (SD 17) minutes compared with 36(24) minutes in the serial processing clinic. In the serial processing clinic 61% of patients waited more than 30 minutes compared with 41% in the quasi-parallel processing clinic. In the serial processing clinic 8% of 142 patients surveyed complained of the time spent waiting. The computer simulation we produced was able to determine waiting times with different clinic structures. The simulation showed that reductions in waiting time up to 30% might be achieved by changing our serial processing clinic to a quasi-parallel processing one. Performance of medical outpatient clinics can be improved by examining and changing clinic management. Computer simulation of outpatient clinics offers a means of assessing the impact of such changes on waiting time in clinic and on waiting lists. (shrink)

To precisely define wisdom has been an ongoing task of philosophers for millennia. Investigations into the psychological dimensions of wisdom have revealed several features that make exemplary persons "wise." Contemporary bioethicists took up this concept as they retrieved and adapted Aristotle's intellectual virtue of phronesis for applications in medical contexts. In this article, we build on scholarship in both psychology and medical ethics by providing an account of clinical wisdom qua phronesis in the context of the practice of psychoanalysis (...) and psychodynamic psychotherapy. With the support of qualitative data, we argue that the concept of clinical wisdom in mental healthcare shares several of the key ethical dimensions offered by standard models of phronesis in medical ethics and serves as a useful, albeit overlooked, reference point for a broader development of virtue-based medical ethics. We propose that the features of clinical wisdom are pragmatic skills that include, but are not limited to, an awareness of balance, the acceptance of paradox, and a particular clinical manner that maintains a deep regard for the other. We offer several suggestions for refining training programs and redoubling efforts to provide long-term mentorship opportunities for trainees in clinical mental healthcare in order to cultivate clinical wisdom. (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)