BackgroundCORE (Clarity and Openness in Reporting: E3-based) Reference (released May 2016 by the European Medical Writers Association [EMWA] and the American Medical Writers Association [AMWA]) is a complete and authoritative open-access user’s guide to support the authoring of clinical study reports (CSRs) for current industry-standard-design interventional studies. CORE Reference is a content guidance resource and is not a CSR Template.TransCelerate Biopharma Inc., an alliance of biopharmaceutical companies, released a CSR Template in November 2018 and recognised CORE Reference as one of (...) two principal sources used in its development.MethodsThe regulatory medical writing and statistical professionals who developed CORE Reference conducted a critical review of the TransCelerate CSR Template. We summarise our major findings and recommendations in this communication. We also re-examined and edited the Version 1 CORE Reference Terminology Table that we first published in 2016, and we present this as Version 2 in this communication.ResultsOur major critical review findings indicate that opportunities remain to refine the CSR Template structure and instructional text, enhance content clarity, add web links to referenced guidance documents, improve transparency to support the broad readership of CSRs, and develop supporting resources.The CORE Reference ‘Terminology Table’ Version 2 includes estimand as a defined term and an adaptation of the original ‘worked study example’ to incorporate the recently evolved concept of ‘estimands’.ConclusionsAs TransCelerate’s CSR Template represents an important milestone in authoring CSRs, we offer CSR authors advice and recommendations on its use, similarities, and differences with CORE Reference and advise them to consider shared interpretations between the two.RegistrationCORE Reference is registered with the EQUATOR Network. The TransCelerate CSR Template is not registered with any external organisation to the knowledge of the authors of this paper. (shrink)

Short’s assertion that Peirce lacked a cohesive philosophical system is critically examined, and the interconnectedness of Peirce’s 1884–1893 “cosmology” with other aspects of his work is explored, countering Short’s claims of its limited systematic relevance. Additionally, Short’s claim that Peirce “expanded empiricism empirically” is scrutinized, and his interpretation of Peirce’s account of perception is criticized. By contrasting Short’s anti-system reading, I highlight the importance of studying Peirce’s philosophy holistically.

The topic of â oeConflict and Harmonyâ exists across many cultures. As a collection of essays from comparative philosophers around the world, this volume represents the latest research on cross-cultural approaches to issues of conflict and the possibilities of harmony. Composed of papers presented at the 2013 Joint Meeting of the Society for Asian and Comparative Philosophy and the Australasian Society for Asian and Comparative Philosophy, the book offers contributions from both early career academics and long-standing researchers, with topics spanning (...) various historical times and places. Subjects explored here include approaches to classical understandings of harmony and conflict from different contexts, the connection embodied experience has with conflict and harmony, and political approaches to harmony and conflict. Through discussions of Indian, Chinese, Greek, and contemporary philosophy, these papers represent the cutting edge of comparative work and its overlaps with history, religious studies, and political science. (shrink)

This book is a cross-cultural intervention in analytic epistemology that offers an alternative to the narrow conception of knowledge as justified true belief. It develops a framework for a comparative epistemology, illustrating the hermeneutic circularity of knowing to accurately and responsibly approach both Western and non-Western philosophy.

Steve Coutinho's Zhuangzi and Early Chinese Philosophy: Vagueness, Transformation and Paradox, is a comparative philosophy project masterfully carried out on two levels, the methodological and the interpretive. Coutinho provides a translation of the Zhuangzi that is both contextually rooted and philosophically rich. Whether or not one agrees with Coutinho's interpretation, there is much to be gleaned from his book. The first few chapters create a meta-philosophical structure that the rest of the book puts to use. Given the lucid movement from (...) development to application, there is something here for both the newcomer to comparative philosophy and those well versed in Warring States Chinese philosophy. To readers in .. (shrink)

If you consult a medical textbook to learn about the pathogenesis of Lyme disease, you will find a standard narrative. You will learn the disease is caused by the spirochete Borrelia burgdorferi, which is transmitted to people by blacklegged ticks . You will also learn that the natural reservoir for spirochetes in the Northeast is the white-footed mouse , and also likely be told that white-tailed deer are the primary host for gravid female ticks. And that is pretty much the (...) whole story. This limited perspective that considers only four species—spirochetes, mice, ticks, and deer—is entrenched by a reductionist paradigm, one that belies the nature of a .. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Peirce on Realism and Idealism by Robert LaneAaron B. WilsonPeirce on Realism and Idealism Robert Lane. Cambridge UP, 2018.Robert Lane's Peirce on Realism and Idealism is the ultimate secondary source for those who wish to engage the forms of realism and idealism that Peirce develops over the course of his writings. Lane could not have given his monograph a more concise and descriptive title. He never strays from (...) the topics of realism and idealism, and it is remarkably complete. It includes extensive discussion on Peirce's basic realism (Lane's term) as well as his extreme scholastic realism (Peirce's term), his basic idealism (Lane's term), and his objective idealism (Peirce's term). It might not be the best resource for those interested in the historical influences on Peirce's forms of realism and idealism. For instance, if one is interested mainly in Peirce's extreme scholastic realism and its roots in scholastic philosophy, Mayorga (2007)1 might still be a more useful resource. Also, Lane leaves much to be said about the epistemological underpinnings of Peirce's forms of realism and idealism. Peirce's theory of perception and his critical common-sensism do not get much attention. Also, there is much in Peirce's later semeiotic writings that could have been brought to bear on the issues.However, I do not see any of these omissions as failures of Lane's work. As I read it, the book's central aims are to determine the following: (1) what metaphysical views did Peirce hold, (2) when did he hold them, (3) are they consistent with one another, and (4) what is the textual evidence that he held them as such. With respect to these aims, Peirce on Realism and Idealism exhibits the gold standard of Peirce scholarship: it is remarkably sensitive to dates, different writings, and contexts of writings, and the reader gets a strong impression that Lane has not left any stone unturned—that he had at least skimmed every word in every lecture, published writing, letter, and unpublished manuscript that Peirce produced.Although the book contains some interpretations about which I have some reservations, which I describe further on, I agree with most of its central claims. This includes the claim that, despite various developments, Peirce had always subscribed to "basic realism": the thesis that there are things independent of what anyone thinks about them. A whole chapter is dedicated to showing that Peirce's 1868–1869 "anti-Cartesian" papers are consistent with basic realism, and I found that chapter very helpful. Another thesis that Lane defends, and that I strongly agree with, is that Peirce held a representationalist view of truth. Truth as "correspondence" with reality is one of two [End Page 107] key aspects of Peirce's account of truth (the other being, as Lane calls it, an "investigative aspect"). After works by Christopher Hookway, Cheryl Misak, and others that attempt to de-emphasize or obscure Peirce's representationalism, perhaps to make him more appealing to contemporary analytic "neopragmatists," it is absolutely refreshing to read a book that embraces Peirce's representationalism without apology.However, in the remainder of this review, I will focus on parts that I found troubling. Some of this trouble is probably due more to Peirce himself than to Lane's interpretation of Peirce. But some of it directly concerns Lane's interpretation. In particular, the parts of chapter 6 concerning Peirce's modal realism, while stimulating and enlightening, are also problematic. Further, I do not think that Lane's account of Peirce's idealism appropriately recognizes its similarity to Hegelian or Absolute idealism.To begin with Peirce's modal realism, Lane's discussion of it sets out by addressing the fact that, as Peirce recognizes, the conditionals comprising "pragmatic clarifications," or what result from applying the "pragmatic maxim" to a concept, must be in the hypothetical or subjunctive mood. This is in order to make sense of the truth of even indicative non-conditional propositions such as, to use Peirce's and Lane's example, "the diamond is hard." If the conditionals into which a concept is pragmatically clarified are in the indicative mood... (shrink)

Idealist and Strong Empiricist approaches to Peirce’s thought are irreconcilable so far as an Idealist interpretation commits Peirce to some form of a priori knowledge, particularly a priori knowledge of the conditions of empirical knowledge. However, while I favor the strong empiricist approach, I agree that there is something like a “condition for the possibility of empirical knowledge” in Peirce, and that this lies with his famous conjecture that, with enough time and experience, there would be a “final result” of (...) all inquiry – “the Final Opinion.” Though some argue that this is mainly a regulative assumption or intellectual hope in Peirce, I contend that he is committed to it as an empirical hypothesis which we should provisionally accept. As an empirical hypothesis, it is not a transcendental constraint on knowledge, though it can be considered a transcendental feature (following Sacks’ (1997) distinction). That is, the thesis explains how knowledge is possible, but the epistemic status of the thesis itself is dependent on the course of experience. Here I explain how it is an empirical thesis and I explain the empirical considerations Peirce thinks support it. Though Peirce should not be considered a transcendental idealist in any robust sense, I give reasons for why he could still be considered a sort of absolute idealist. (shrink)

Abstract:Peirce held a convergence theory of moral truth, as James Liszka persuasively argues in Charles Peirce on Ethics, Esthetics, and the Normative Sciences (2021). Here I emphasize: (1) that Peirce's convergence theory follows from the application of the maxim of pragmatism to the concept of moral goodness or rightness; (2) that in connection with Peirce's account of the ethical summum bonum, morally right action can be understood as action that conforms or contributes to the growth of concrete reasonableness; and (3) (...) that, for Peirce, the growth of concrete reasonableness seems to be a movement or development toward "God". While I broadly agree with Liszka's approach, I highlight some disagreements. As do many readers of Peirce, Liszka seems to regard the convergence of beliefs and habits as necessarily a convergance among the "indefinite community" of distinct persons or inquirers; however, there is sufficient evidence that Peirce came to think that, if any given person were to live long enough, they would come to the same conclusions or rest in the same habits on their own. With respect to morality, even the most evil person would eventually come around to the moral truth. (shrink)

This article is an initial attempt to compare the pre-abortion disclosure mandates that have proliferated in the two decades since the Court decided Planned Parenthood v. Casey with laws that, in the context of assisted reproduction and reproductive health, require specific disclosures beyond a state's baseline informed consent requirements. While some scholars have characterized pre-abortion disclosure laws as sui generis, they share some important common features with disclosure mandates in the context of oocyte donation and other reproductive health procedures. This (...) article suggests that in critiquing pre-abortion disclosure mandates, scholars and advocates should be careful to differentiate the use of disclosure laws in general from uses where the government interest conveys a moral preference against a particular procedure. (shrink)

Introduction Recent years have seen increased interest in the complex relationships between the thought of German Idealists (understood to include both transcendental and absolute idealists) and the thought of those philosophers commonly categorized as “American Pragmatists” – from Charles S. Peirce (the progenitor of this alleged tradition) to Richard Rorty and his student, Robert Brandom. This issue presents a collection of papers that, as a collection, do justice to those complex relations...

Games and simulations--from quantitative modeling to immersive, experiential scenarios--as methods for engagement within futures studies have a substantial history. In recent years, there has been a surge of projects using a wide array of tools. As practitioners and researchers have gravitated toward more playful approaches, there is a need to review and evaluate such approaches. This chapter provides an introduction to gaming and simulations as anticipatory processes. Offering a snapshot of contemporary projects from around the world, this chapter utilizes a (...) range of voices and perspectives on gaming and simulations to explore how such tools and methods use the future. (shrink)

In the 1930s, the Home Owners’ Loan Corporation (HOLC) graded the mortgage security of urban US neighborhoods. In doing so, the HOLC engaged in the practice, imbued with racism and xenophobia, of “redlining” neighborhoods deemed “hazardous” for lenders. Redlining has caused persistent social, political and economic problems for communities of color. Linkages between redlining and contemporary food access remain unexamined, even though food access is essential to well-being. To investigate this, we used a census tract-level measure of low-income and low (...) grocery store food access from the US Department of Agriculture Food Access Research Atlas, redlining data from Mapping Inequality Project, and demographic data from the American Community Survey. We employed generalized estimating equations with robust covariance estimates to analyze data pertaining to 10,459 census tracts in 202 US cities. Tracts that the HOLC graded as “C” (“decline in desirability”) and “D” (“hazardous”) had reduced contemporary food access compared to those graded “A” (“best”). Increases in contemporary census tract proportions of Black, Hispanic, or other racial/ethnic minority residents, as well as disabled residents, were associated with reduced food access. Increases in contemporary proportions of residents age 75 years and older or those without a car were associated with better food access. Tracts that underwent housing redevelopment since being graded had better food access, while those undergoing gentrification had reduced food access. Results suggest that issues of redlining, housing discrimination, racism, ableism, displacement, and food inaccessibility are deeply intertwined. (shrink)

As genomic science has evolved, so have policy and practice debates about how to describe and evaluate the ways in which genomic information is treated for individuals, institutions, and society. The term genetic exceptionalism, describing the concept that genetic information is special or unique, and specifically different from other kinds of medical information, has been utilized widely, but often counterproductively in these debates. We offer genomic contextualism as a new term to frame the characteristics of genomic science in the debates. (...) Using stasis theory to draw out the important connection between definitional issues and resulting policies, we argue that the framework of genomic contextualism is better suited to evaluating genomics and its policy-relevant features to arrive at more productive discussion and resolve policy debates. (shrink)

This volume offers the first English language collection of academic essays on the post-Holocaust thought of Jean Améry, a Jewish-Austrian-Belgian essayist, journalist and literary author. Comprehensive in scope and multi-disciplinary in orientation, contributors explore central aspects of Améry's philosophical and ethical position, including dignity, responsibility, resentment, and forgiveness.

This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.

In Portraits of American Philosophy, eight of America's most prominent philosophers offer autobiographical narratives that remind us that the life of a scholar is both a tale of personal struggle and an adventure in ideas.

This article investigates the moderating effects of organizational social consciousness on the natural environmental competency and innovativeness relationship. Organizational social consciousness reflects the organization’s awareness of its place and contribution to the larger system in which it exists and is developed through an organization’s social responsibility, ethics, culture, corporate values, and the view of its stakeholders. Through our study of key strategic decision makers from organizations located in the USA, we operationalize organizational social consciousness and demonstrate the efficacy of this (...) construct in relation to the organizational-level constructs of environmental management competency and innovativeness. Our results reveal that organizational social consciousness positively strengthens the natural environmental competency to organizational innovativeness relationship. (shrink)

The “right to repair” movement highlights opportunities to reduce health care costs and promote public health resilience through increased competition in the way in which medical devices are serviced and updated over their lifespan. We review legislative and legal facets of third-party repair of medical devices, and conclude with specific recommendations to help this market function more efficiently to the benefit of patients and health care systems.

This study analyzes 435 oocyte donor recruitment advertisements to assess whether entities recruiting donors of oocytes to be used for in vitro fertilization (IVF) procedures include a disclosure of risks associated with the donation process in their advertisements. Such disclosure is required by the self-regulatory guidelines of the American Society for Reproductive Medicine (ASRM) and by law in California for advertisements placed in the state. We find very low rates of risk disclosure across entity types and regulatory regimes, although risk (...) disclosure is more common in advertisements placed by entities subject to ASRM's self-regulatory guidelines. Advertisements placed in California are more likely to include risk disclosure, but disclosure rates are still quite low. California-based entities advertising outside the state are more likely to include risk disclosure than non-California entities, suggesting that California's law may have a modest “halo effect.” Our results suggest that there is a significant ethical and policy problem with the status quo in light of the known and unknown risks of oocyte donation and the importance of risk disclosure to informed consent in the context of oocyte donation. (shrink)

In vitro fertilization using donated oocytes has proven to be an effective treatment option for many prospective parents struggling with infertility, and the usage of donated oocytes in assisted reproduction has increased markedly since the technique was first successfully used in 1984. Data published by the Centers for Disease Control and Prevention on the use of assisted reproductive technologies in the United States indicate that approximately 12% of all ART cycles in the country now use donated oocytes. The increased use (...) of oocyte donation in the United States has prompted discussion regarding risks associated with the process and how best to ensure the safety of oocyte donors.Physical risks associated with oocyte donation include bleeding, infection, ovarian hyperstimulation syndrome and a potential, although unconfirmed, increased risk of developing various forms of cancer, such as uterine, colon, breast, ovarian, and endometrial cancers. (shrink)

The US neutrino community gathered at the Workshop on the Intermediate Neutrino Program at Brookhaven National Laboratory February 4-6, 2015 to explore opportunities in neutrino physics over the next five to ten years. Scientists from particle, astroparticle and nuclear physics participated in the workshop. The workshop examined promising opportunities for neutrino physics in the intermediate term, including possible new small to mid-scale experiments, US contributions to large experiments, upgrades to existing experiments, R&D plans and theory. The workshop was organized into (...) two sets of parallel working group sessions, divided by physics topics and technology. Physics working groups covered topics on Sterile Neutrinos, Neutrino Mixing, Neutrino Interactions, Neutrino Properties and Astrophysical Neutrinos. Technology sessions were organized into Theory, Short-Baseline Accelerator Neutrinos, Reactor Neutrinos, Detector R&D and Source, Cyclotron and Meson Decay at Rest sessions.This report summarizes discussion and conclusions from the workshop. (shrink)

Coronavirus disease 2019 can lead to respiratory failure. Some patients require extracorporeal membrane oxygenation support. During the current pandemic, health care resources in some cities have been overwhelmed, and doctors have faced complex decisions about resource allocation. We present a case in which a pediatric hospital caring for both children and adults seeks to establish guidelines for the use of extracorporeal membrane oxygenation if there are not enough resources to treat every patient. Experts in critical care, end-of-life care, bioethics, and (...) health policy discuss if age should guide rationing decisions. (shrink)

The COVID-19 pandemic has resulted in widespread disruption of the typical way of doing things. In nearly every industry, responses to the pandemic have brought about departures from standard opera...

_John Dewey and Continental Philosophy_ provides a rich sampling of exchanges that could have taken place long ago between the traditions of American pragmatism and continental philosophy had the lines of communication been more open between Dewey and his European contemporaries. Since they were not, Paul Fairfield and thirteen of his colleagues seek to remedy the situation by bringing the philosophy of Dewey into conversation with several currents in continental philosophical thought, from post-Kantian idealism and the work of Friedrich Nietzsche (...) to twentieth-century phenomenology, hermeneutics, and poststructuralism. This unique volume includes discussions comparing and contrasting Dewey with the German philosophers G. W. F. Hegel, Friedrich Nietzsche, Martin Heidegger, and Hans-Georg Gadamer on such topics as phenomenology, naturalism, organicism, contextualism, and poetry. Others investigate a series of connections between Dewey and contemporary French philosophy, including the notions of subjectivity, education, and the critique of modernity in Michel Foucault; language and politics in Jacques Derrida; and the concept of experience in Gilles Deleuze. Also discussed is the question of whether we can identify traces of _Bildung_ in Dewey’s writings on education, and pragmatism’s complex relation to twentieth-century phenomenology and hermeneutics, including the problematic question of whether Heidegger was a pragmatist in any meaningful sense. Presented in intriguing pairings, these thirteen essays offer different approaches to the material that will leave readers with much to deliberate. _ John Dewey and Continental Philosophy_ demonstrates some of the many connections and opportunities for cross-traditional thinking that have long existed between Dewey and continental thought, but have been under-explored. The intersection presented here between Dewey’s pragmatism and the European traditions makes a significant contribution to continental and American philosophy and will spur new and important developments in the American philosophical debate. (shrink)

The FDA's new table of surrogate endpoints used for drug approvals is an important step forward for overseeing the use of biomarkers in clinical trials. Nevertheless, we present several ways in which the table can be improved.

Abstract: Philosophers interested in Kant's relevance to contemporary debates over the nature of mental content—notably Robert Hanna and Lucy Allais—have argued that Kant ought to be credited with being the original proponent of the existence of ‘nonconceptual content’. However, I think the ‘nonconceptualist’ interpretations that Hanna and Allais give do not show that Kant allowed for nonconceptual content as they construe it. I argue, on the basis of an analysis of certain sections of the A and B editions of the (...) Transcendental Deduction, for a ‘conceptualist’ reading of Kant's Critique of Pure Reason. My contention is that since Kant's notion of empirical intuition makes essential reference to the categories, it must be true for him that no empirical intuition can be given in sensibility independently of the understanding and its categories. (shrink)

Two conundrums puzzle COVID‐19 investigators: 1) morbidity and mortality is rare among infants and young children and 2) rates of morbidity and mortality exhibit large variances across nations, locales, and even within cities. It is found that the higher the rate of pneumococcal vaccination in a nation (or city) the lower the COVID‐19 morbidity and mortality. Vaccination rates with Bacillus Calmette–Guerin, poliovirus, and other vaccines do not correlate with COVID‐19 risks, nor do COVID‐19 case or death rates correlate with number (...) of people in the population with diabetes, obesity, or adults over 65. Infant protection may be due to maternal antibodies and antiviral proteins in milk such as lactoferrin that are known to protect against coronavirus infections. Subsequent protection might then be conferred (and correlate with) rates of Haemophilus influenzae type B (Hib) (universal in infants) and pneumococcal vaccination, the latter varying widely by geography among infants, at‐risk adults, and the elderly. Also see the video abstract here https://youtu.be/GODBYRbPL00. (shrink)

In the conclusion to this multi-part article I first review the discussions carried out around the six essential questions in psychiatric diagnosis – the position taken by Allen Frances on each question, the commentaries on the respective question along with Frances’ responses to the commentaries, and my own view of the multiple discussions. In this review I emphasize that the core question is the first – what is the nature of psychiatric illness – and that in some manner all further (...) questions follow from the first. Following this review I attempt to move the discussion forward, addressing the first question from the perspectives of natural kind analysis and complexity analysis. This reflection leads toward a view of psychiatric disorders – and future nosologies – as far more complex and uncertain than we have imagined. (shrink)

The Covid‐19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions. Ensuring that the FDA is itself trustworthy is important for justifying public trust in its actions, like vaccine approvals, thereby promoting public health. We propose five conditions of trustworthiness that the FDA should meet when it reviews vaccines, even during emergencies: consistency with rules, proper expert or political decision‐makers, proper (...) decision‐making and noninterference, connection to public preference, and transparency of both reasons and procedures. The five conditions provide a road map of procedural and substantive requirements, which the FDA has variably implemented, focused on ensuring appropriate influence of political interests. While being a trustworthy agency cannot guarantee the public's trust, implementing these conditions builds a groundwork for public trust. (shrink)