In current philosophical discussions on evidence in the medical sciences, epidemiology has been used to exemplify a specific version of evidential pluralism. According to this view, known as the Russo–Williamson Thesis, evidence of both difference-making and mechanisms is produced to make causal claims in the health sciences. In this paper, I present an analysis of data and evidence in epidemiological practice, with a special focus on research on the exposome, and I cast doubt on the extent to which evidential (...) pluralism holds in this case. I start by focusing on the claim that molecular data allows for the production of mechanistic evidence. On the basis of a close look at the ways in which molecular data is used in exposome research, I caution against interpretations in terms of mechanistic evidence. Secondly, I expand my critical remarks on the thesis by addressing the conditions under which data is categorised as evidence in exposome research. I argue that these show that the classification of a dataset as a type of evidence is dependent on the ways in which the data is used. This is in contrast with the approach of evidential pluralism, where evidence is classified in different types on the basis of its intrinsic properties. Finally, I come back to what I consider the core of the thesis and suggest that the epidemiological research analysed in the paper indicates different interpretations of evidential pluralism and its applicability in the health sciences. (shrink)

With the aim of ascertaining if child-to-parent offenders have impairments in the executive functions and psychological maladjustment, and to quantify the potential harm and epidemiology, a field study was designed. As for this, 76 juvenile offenders sentenced for child-to-parent violence were assessed in executive functions and psychological adjustment. The results showed valid responses for 75 juveniles and that data were not generally biased in line with defensiveness or malingering. In psychological adjustment, the results revealed a significantly higher maladjustment among (...) offenders on all the basic clinical scales with 23% more symptoms of hysteria than the normative population, 37% more of depressive symptoms, 44% more of hypochondriac symptoms, 68% more of psychopathic deviation symptoms, 46% more of paranoid symptoms, 26% more of psychasthenic symptoms, 24% more symptoms of schizophrenia, 17% more symptoms of hypomania, and 13% more symptoms of social introversion. Epidemiologically, the prevalence rates of clinical deterioration were significantly greater than expected in hypochondria, depression, hysteria, psychopathic deviation, paranoia, psychasthenia, and schizophrenia. As for the cognitive functions, the offenders exhibited impairments estimated at 62.0% in word reading, 47.9% in color naming, 45.8% in color-word, and 11.9% in interference and a significantly higher prevalence of caseness than expected in word reading, color naming, and color-word. The implications of the results for intervention are discussed. (shrink)

There are many tangled normative and technical questions involved in evaluating the quality of software used in epidemiological simulations. In this paper we answer some of these questions and offer practical guidance to practitioners, funders, scientific journals, and consumers of epidemiological research. The heart of our paper is a case study of the Imperial College London covid-19 simulator, set in the context of recent work in epistemology of simulation and philosophy of epidemiology.

Clinical research must be understood to be the foundation of scientific medicine of the clinical type. But the essence of scientific clinical medicine remains a matter of profound confusion, even in clinical academia, and so does the essence of clinical research. The confusion now revolves, principally, around ‘clinical epidemiology’. We address clinical research in the meaning of quintessentially ‘applied’ clinical research, which we take to be the foundation of the scientific knowledge base of clinical medicine, of gnosis (dia‐, etio‐, (...) pro‐) in it. More specifically, we address the essence, priorities, and status quo of this research – and argue that the requisite theory of this is not a matter of ‘clinical epidemiology’ but of theory of clinical research endogenous to clinical (rather than epidemiological) academia. (shrink)

Background: Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeutic research. However, there appears to be very little work conducted with participants who have joined non-therapeutic research. This work was done to evaluate participants' perception of benefits in a genetic epidemiological study by examining their perception of the potential benefits of enrollment.Methods: In-depth (...) interviews lasting between 45 and 60 minutes were conducted with a convenient sample of 25 ill patients and 25 healthy accompanying relatives enrolled in a genetic epidemiological study of tuberculosis. Recorded interviews were transcribed and analyzed using content analysis.Results: Participants perceived that research was beneficial and some of the benefits included the generation of new knowledge, finding the cause of diseases, as well as the control, eradication and prevention of disease. Some thought that research was risky whilst others thought that the benefits outweighed the risks.Conclusion: Participants perceived research to be beneficial and most of them thought that, though it was risky, the benefits outweighed the risks. It is our view that researchers need to give serious consideration to participant's perception of benefits in designing their consent forms, to see to the fulfillment of achievable goals. (shrink)

The case of John Snow has long been important to epidemiologists and public health officials. However, despite the fact that there have been many discussions about the various aspects of Snow’s case, there has been virtually no discussion about what guided Snow’s reasoning in his coming to believe his various conclusions about cholera. Here, I want to take up this question in some detail and show that there are a number of specific principles of reasoning that played a crucial role (...) for Snow. Moreover, these principles were episte- mologically important to Snow, a fact about which Snow is explicit in many places. An analysis of Snow’s case suggests that, because of the epistemic role such principles of reasoning can play, health care practitioners ought to understand their practices to be theoretically informed in these ways, and not just data driven. (shrink)

Objective: This paper describes the variety of ways that information about ethics-related methods are included or not included in public health research articles. Methods: Information about the ethics-related content of all articles published in nine highly-respected public health journals in 2006 was extracted. Results: Of 989 primary analyses, 73% of the articles commented on ethics committee approval or exemption, 63% mentioned participant consent and 9% indicated whether or not inducement or compensation was given. 84% of articles mentioned a funding source, (...) but fewer than 4% identified any potential conflict of interest. Reporting rates for committee review and consent were higher for experimental than for observational studies and were comparatively higher in studies conducted among potentially vulnerable populations like children and residents of low income countries. Conclusions: More complete reporting would facilitate the design, evaluation and comparison of future research studies. (shrink)

La possibilité d’une définition naturaliste de la santé et d’une distinction entre le normal et le pathologique qui ne repose pas sur des normes culturelles, sociales ou subjectives est au cœur des débats en philosophie de la médecine. Or le concept statistique de la normalité, fondamental pour une définition objective de la santé, soulève d’importantes difficultés. Christopher Boorse défend une « théorie bio-statistique » qui, en articulant ce concept à une notion non normative de fonction biologique, résoudrait ces difficultés. L’identification (...) de la santé et de la normalité au sens statistique demeure toutefois centrale dans sa définition. Après avoir précisé le rôle que joue la normalité statistique dans la BST, nous dégageons, à partir de l’épidémiologie contemporaine, un certain nombre de problèmes et questions que cette définition naturaliste soulève.The liability for a naturalist definition of health and for a value-free distinction between the normal and the pathological is at the core of discussions on health and disease in philosophy of medicine. But the statistical concept of normality, a central one for any objective definition of health, raises numerous problems. Christopher Boorse argues for a « biostatistical theory » which aims at solving these difficulties by articulating a statistical concept of normality and a non-normative concept of biological function. However the BST is still based on identifying normality and health with the most frequent. After analyzing in details the true role of statistical normality in BST, I will show how results and data from modern epidemiology can be mobilized to reveal several limits and difficulties with respect to this naturalist definition of health and disease. (shrink)

This article combines a philosophical critique of the idea that public health nurses are primary technicians who neutrally hand over scientifically established facts on risks to the public and an empirical analysis of the actual work of public health nurses. It is argued that the relationship between facts and values in public health is complex and that, despite the introduction of several scientifically-based standards and guidelines, public health nurses are not technicians. They do moral work and experience ethical dilemmas. To (...) get a grip on the specific character of this moral work, we distance ourselves from the idea that there are ethical dilemmas in public health nursing for which we can provide general ethical rules and principles. Instead we suggest a contextual ethical approach, in which several different kinds of consideration may be important. To illustrate this, we analysed 15 in-depth interviews with nurses involved in the prevention of cot deaths in the Netherlands. It is shown that these nurses do not neutrally pass on the epidemiological facts on the risks of prone sleeping, warm bedclothes and passive smoking, but they are the moral architects of this preventive practice. It is also shown that this moral work and the ethical dilemmas they experience cannot be characterized in terms of general ethical rules and principles. It becomes clear that the moral work of nurses differs according to the three main risks at stake: the balance between virtue, risk taking and responsibility depends on the specific context. (shrink)

Patient-Centered Care and Cultural Practices: Process and Criteria for Evaluating Adaptations of Norms and Standards in Health Care Institutions Content Type Journal Article Pages 327-339 DOI 10.1007/s10730-009-9115-8 Authors Matthew R. Hunt, McMaster University Department of Clinical Epidemiology and Biostatistics Montreal Canada Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737 Journal Volume Volume 21 Journal Issue Volume 21, Number 4.

Most of the epidemiological models of the Covid-19 pandemic contain the reproduction number as a parameter. In this article we focus on some shortcomings regarding its role in driving health policies and political decisions. First, we summarize what R is and what it is used for. Second, we introduce a three-question matrix for the evaluation of any construct or parameter within a model. We then review the main literature about R to highlight some of its shortcomings and apply to them (...) our three-question matrix. Finally, we argue that these shortcomings are important for an epistemic and political evaluation of R. (shrink)

Proponents of evidence-based medicine have argued convincingly for applying this scientific method to medicine. However, the current methodological framework of the EBM movement has recently been called into question, especially in epidemiology and the philosophy of science. The debate has focused on whether the methodology of randomized controlled trials provides the best evidence available. This paper attempts to shift the focus of the debate by arguing that clinical reasoning involves a patchwork of evidential approaches and that the emphasis on (...) evidence hierarchies of methodology fails to lend credence to the common practice of corroboration in medicine. I argue that the strength of evidence lies in the evidence itself, and not the methodology used to obtain that evidence. Ultimately, when it comes to evaluating the effectiveness of medical interventions, it is the evidence obtained from the methodology rather than the methodology that should establish the strength of the evidence. (shrink)

The International Agency for Research on Cancer (IARC) is an organization which seeks to identify the causes of human cancer. Per agent, such as betel quid or Human Papillomaviruses, they review the available evidence deriving from epidemiological studies, animal experiments and information about mechanisms (and other data). The evidence of the different groups is combined such that an overall assessment of the carcinogenicity of the agent in question is obtained. In this paper, we critically review the IARC’s carcinogenicity evaluations. First (...) we show that serious objections can be raised against their criteria and procedures – more specifically regarding the role of mechanistic knowledge in establishing causal claims. Our arguments are based on the problem of confounders, of the assessment of the temporal stability of carcinogenic relations, and of the extrapolation from animal experiments. Then we address a very important question, viz. how we should treat the carcinogenicity evaluations that were based on the current procedures. After showing that this question is important, we argue that an overall dismissal of the current evaluations would be too radical. Instead, we argue in favour of a stepwise re-evaluation of the current findings. (shrink)

The epidemiological situation resulting from the SARS-CoV-2 pandemic caused the Polish universities to fully switch to distance education in March 2020. Medical e-learning has not yet been broadly implemented into the education process. Therefore, examples of successful e-learning implementations or the organization of the process of medical e-learning offer a valuable source of knowledge today, which is needed immediately. The article presents e-learning practices at the Polish medical universities during the SARS-CoV-2 epidemic during the period from March to September 2020, (...) covering seven universities in Poland that offer medical and health studies. The organization and implementation of e-learning classes is presented, including knowledge evaluation practices, providing example decisions issued by university rectors, on which the teaching process was based. A detailed presentation of the schools’ organizational units or workgroups that played an important role in the process of coordination of measures supporting e-education is also included. The article also presents a description of the software applications, utilities, and services used at the schools in the course of the process of online education. Below are some examples of specific such implementations in selected university courses. (shrink)

Models not only represent but may also influence their targets in important ways. While models’ abilities to influence outcomes has been studied in the context of economic models, often under the label ‘performativity’, we argue that this phenomenon also pertains to epidemiological models, such as those used for forecasting the trajectory of the Covid-19 pandemic. After identifying three ways in which a model by the Covid-19 Response Team at Imperial College London may have influenced scientific advice, policy, and individual responses, (...) we consider the implications of epidemiological models’ performative capacities. We argue, first, that performativity may impair models’ ability to successfully predict the course of an epidemic; but second, that it may provide an additional sense in which these models can be successful, namely by changing the course of an epidemic. (shrink)

Epidemiological studies have shown that environmental green space contributes to the reduction of psychosis incidence in the population. Clarifying the psychological and neuro-functional mechanisms underlying the risk-decreasing effects of green surroundings could help optimize preventive environmental interventions. This perspective article specifically aims to open a new window on the link between environmental green space and psychosis by considering its core psychopathological features. Psychotic disorders, such as schizophrenia, are essentially characterized by self-disturbances. The psychological structure of the self has been described (...) as a multidimensional phenomenon that emerges from the reciprocal interaction with the environment through intrinsic and extrinsic self-processes. The intrinsic self refers to the experience of mental activity and environmental information as inherently related to one’s own person, which involves self-referential processing, self-reflection, memory, interoception, and emotional evaluation. The extrinsic self refers to sensorimotor interactions with the environment and the sense of agency, that is, the experience of being the source of one’s own actions and the multisensory consequences thereof. In psychosis, anomalous self-processing has been related to a functional fragmentation of intrinsic and extrinsic self-processes and related brain networks. Moreover, evidence from cognitive neuroscience suggests that green space could have beneficial effects on self-related processing. Based on the literature, it could be hypothesized that self-processing is involved in mediating the beneficial effects of green space for psychosis. Considering the multidimensionality of the self, it is proposed that urban green space design aimed at improving mental health ideally impacts the complexity of self-facets and thus restores the individual’s self. (shrink)

This paper evaluates the content of the syllabi of postgraduate courses on public health ethics within accredited schools and programs of public health in the United States in order to gain an awareness of the topics addressed within these courses. Methods: Data was gathered via the analysis of syllabi of courses on PHE. In 2012, information was requested by e-mail from the 48 schools and 86 PH programs accredited by the U.S. Council on Education for Public Health for 2012. The (...) “Epidemiology and PHE Syllabi” project of the University of Miami also was consulted. A table of topics was drawn up in order to carry out content analysis of the documents. Results: Data was obtained from 25 schools and 36 accredited programs ; 36 syllabi were gathered and 75 different topics were found. Of these, 38 topics were addressed in six or more syllabi and can be grouped as follows: foundations of PHE; autonomy and its limits; infectious disease control; justice; research ethics; health education and promotion; environmental and occupational health; screening; genetics; privacy and confidentiality; and community-based practice and vulnerable populations. Conclusions: The analyzed syllabi show high variability in curricular content. The debate with regard to whether a core curriculum on PHE should be established is ongoing. The results of this work might be of interest for schools and programs of PH in other countries or regions of the world in order to develop or ameliorate their own PHE syllabi. (shrink)

Integrative explanations of why obesity is more prevalent in some sectors of the human population than others are lacking. Here, we outline and evaluate one candidate explanation, the insurance hypothesis. The IH is rooted in adaptive evolutionary thinking: The function of storing fat is to provide a buffer against shortfall in the food supply. Thus, individuals should store more fat when they receive cues that access to food is uncertain. Applied to humans, this implies that an important proximate driver of (...) obesity should be food insecurity rather than food abundance per se. We integrate several distinct lines of theory and evidence that bear on this hypothesis. We present a theoretical model that shows it is optimal to store more fat when food access is uncertain, and we review the experimental literature from non-human animals showing that fat reserves increase when access to food is restricted. We provide a meta-analysis of 125 epidemiological studies of the association between perceived food insecurity and high body weight in humans. There is a robust positive association, but it is restricted to adult women in high-income countries. We explore why this could be in light of the IH and our theoretical model. We conclude that although the IH alone cannot explain the distribution of obesity in the human population, it may represent a very important component of a pluralistic explanation. We also discuss insights it may offer into the developmental origins of obesity, dieting-induced weight gain, and anorexia nervosa. (shrink)

This timely book analyses and evaluates ethical and social implications of recent developments in reporting surgeon performance. It contains chapters by leading international specialists in philosophy, bioethics, epidemiology, medical administration, surgery, and law, demonstrating the diversity and complexity of debates about this topic, raising considerations of patient autonomy, accountability, justice, and the quality and safety of medical services. Performance information on individual cardiac surgeons has been publicly available in parts of the US for over a decade. Survival rates for (...) individual cardiac surgeons in the UK have recently been released to the public. This trend is being driven by various factors, including concerns about accountability, patients' rights, quality and safety of medical care, and the need to avoid scandals in medical care. This trend is likely to extend to other countries, to other clinicians, and to professions beyond health care, making this text an essential addition to the literature available. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Chair’s Perspective on the Work of the Advisory Committee on Human Radiation ExperimentsRuth Faden (bio)On January 15, 1994, President Clinton created the Advisory Committee on Human Radiation Experiments in response to his concern about the increasing number of reports describing alleged unethical conduct of the U.S. Government, and institutions funded by the government, in the use of, or exposure to, ionizing radiation in human beings at the height of (...) the Cold War. He directed the Committee: (1) to uncover the history of human radiation experiments and intentional environmental releases of radiation; (2) to identify the ethical and scientific standards for evaluating these events; and (3) to make recommendations to ensure that whatever wrongdoing may have occurred in the past will not be repeated.The Committee was composed of 14 members: a citizen representative and 13 experts in bioethics, radiation oncology and biology, epidemiology and statistics, public health, history of science and medicine, nuclear medicine, and law. We reported to a cabinet-level group (the Human Radiation Interagency Working Group) convened by the president, which includes the secretaries of defense, energy, health and human services, and veterans affairs; the attorney general; the administrator of the National Aeronautics and Space Administration; the director of the Central Intelligence Agency; and the director of the Office of Management and Budget.On April 21, 1994, at the end of the first day of our first meeting, President Clinton invited us to the White House to personally communicate his commitment to the process we were about to undertake. He urged us to be fair, thorough, and unafraid to shine the light of truth on this hidden and poorly understood aspect of our nation’s past. Our most important task, he said, was to tell the full story to the American public. [End Page 215] At the same time, we were to examine the present, to determine how the conduct of human research today compares with that of the past, and to assess whether, in light of this inquiry, changes need to be made in the policies of the federal government. Eighteen months later, the Committee’s attempt to tell the story of the past and to report on our inquiry into the present was delivered to the president in a 900-page Final Report (ACHRE 1995) and several supplemental volumes.The Committee’s charge was enormous. We were asked to conduct a massive investigation into events that occurred as much as 50 years ago and that involved the highest reaches of the defense establishment and the medical community. This investigation necessitated an examination of the conduct and policies of six federal agencies and countless agents in the private sector, as well as the location and interpretation of hundreds of thousands of documents, many of which were buried in obscure locations or were still classified.In addition, the Committee was instructed to establish standards for judging, in moral terms, the events that it uncovered. This charge necessitated the confrontation of contentious debates in moral thought and theory about history, relativism, and the significance of context in moral judgment. But our purpose was not to engage in these debates in the abstract. Although the Committee was not expressly charged with considering issues relating to remedies, including financial compensation, we felt obliged to address the type of remedies that we believed the government, as an ethical matter, should provide to subjects of experiments where the circumstances warranted such a response. Thus our deliberations about relativism and moral judgment were tied to concrete recommendations for public policy and were conducted in a public context that included participants from numerous adversarial legal proceedings.In tandem with our reconstruction of the past, we undertook three projects to examine the current state of human radiation experiments. First, we studied how each federal agency that currently conducts or funds research involving human subjects regulates and oversees its research activity. Second, from among the very large number of federally-supported research projects involving human subjects, we randomly selected 125 projects for closer scrutiny. We reviewed all available relevant documentation for each project in order to assess how well it appeared to protect the rights and interests of the participating subjects. Third... (shrink)

COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies ) with SARS-CoV-2. Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes. Systematic risk evaluations are critical to inform assessments of the ethics of any proposed SARS-CoV-2 CHIs. Such (...) evaluations will necessarily take place within a rapidly changing and at times contested epidemiological landscape, in which differing criteria for the ethical acceptability of research risks have been proposed. This paper critically reviews two such criteria and evaluates whether the use of effective treatment should be a necessary condition for the ethical acceptability of SARS-CoV-2 CHIs, and whether the choice of study sites should be influenced by COVID-19 incidence levels. The paper concludes that ethical evaluations of proposed SARS-CoV-2 CHIs should be informed by rigorous, consultative and holistic approaches to systematic risk assessment. (shrink)

We compared two digital humanities methods in the analysis of a contested scientific term. “Epigenetics” is as enigmatic as it is popular. Some authors argue that its meaning has diluted over time as this term has come to describe a widening range of entities and mechanisms (Haig, International Journal of Epidemiology 41:13–16, 2012). Others propose both a Waddingtonian “broad sense” and a mechanistic “narrow sense” definition to capture its various scientific uses (Stotz and Griffiths, History and Philosophy of the (...) Life Sciences 38:22, 2016). We evaluated these proposals by first replicating a recent analysis by (Linquist and Fullerton, Theoretical Medicine and Bioethics 42:137–154, 2021). We analyzed the 1100 most frequently cited abstracts on epigenetics across four disciplines: proximal biology, biomedicine, general biology, and evolution. Each abstract was coded for its heritability commitments (if any) and functional interpretation. A second study applied LDA topic modelling to the same corpus, thus providing a useful methodological comparison. The two methods converged on a discipline-relative ambiguity. Within such disciplines as biomedicine or molecular biology that focus on proximate mechanisms, “epigenetic(s)” refers to a range of molecular structures while specifying nothing in particular about their heritability. This proximal conception was primarily associated with the functions of gene regulation and disease. In contrast, a second relatively uncommon sense of “epigenetic(s)” is restricted to a small proportion of evolutionary abstracts. It refers to many of the same molecular structures, but regards them as trans-generationally inherited and associated with adaptive phenotypic plasticity. This finding underscores the benefit of digital tools in complementing traditional conceptual analysis. Philosophers should be cautious not to conflate the relatively uncommon evolutionary sense of epigenetics with the more widely used proximal conception. (shrink)

The contribution of food and diet to health is much disputed in the background culture in the US. Many commercial or ideological advocates make claims, sometimes with health as a primary goal, but often accompanied by commercial or ideological interests. These compete culturally with authoritative recommendations made by publicly funded groups. For public policy concerning diet and health to be legitimate, not only should it not be inconsistent with the scientific evidence, but also it should not be inconsistent with the (...) political environment. Healthy Eating Policy and Political Philosophy (HEPPP), by Barnhill and Bonotti (2022), addresses how policy in this complex area might be justified. In the present essay I highlight some important strengths of their work and also make some points about how it might be clarified or enlarged in scope. The great strength of HEPPP is that it emphasizes the role of a political philosophy in evaluating the legitimacy of public policy. They presume a well-off liberal democratic state, and specifically they draw on Rawls’ political liberalism, as developed in Political Liberalism (PL). One of several interlocking technical concepts developed in this book, public reason speaks to the boundaries of what should be acceptable in public deliberation about constitutional essentials and basic justice. HEPPP explores the application of an extension of public reason to the justification of policies related to “healthy eating.“ Public reason has two components, both of which pertain to a common understanding among citizens: (1) a common understanding of the principles and ideals that are the foundation of the political society, and (2) a common understanding of the standards that govern reason and evidence, including common sense. HEPPP argues that even though for diet and health the complexity of the scientific evidence goes far beyond anything like common sense for a typical citizen, the technical idea of “accessibility” of the scientific evidence justifies reliance on it within the concept of public reason. I question this accessibility argument about scientific evidence and public reason because the nature of the population-level epidemiological evidence about diet and health is that it often includes judgments that are based on arguable interpretations, framing incidence in terms of risk and prevention; thus the issue is more than one of potential accessibility of scientific evidence. Nevertheless, evaluation and consideration of the scientific evidence is of obvious practical importance in policy deliberation concerning policy related to what Rawls call “ordinary legislation.“ Even though public reason applied to healthy eating policy may not be as pertinent as it is for constitutional essentials and basic justice, and even though it is unlikely to result in a “correct outcome,“ invoking reasons based on political values and principles held in common has important value even in these deliberations about more ordinary questions. That value applies not to the specifics of the particular issue, but to the larger context for the particular policy being deliberated, as a potential contribution to an overlapping consensus that is stable for the right reasons. If this vision of political liberalism were achieved, then contentious debate about health eating policy and its scientific basis could occur within that context and be resolved within the basic political structure. Because public health and political liberalism have a common concern for a good at the population level, they have an underlying affinity. Healthy eating policies could be evaluated in two not-unrelated ways: based on their instrumental contribution to the good of the public body of citizens as population-level health, and according to their stabilizing contribution to an overlapping consensus among citizens. In this latter way a policy would contribute to a conditional integral common good a la Sulmasy, one that has the prospect of conditioning a political system, and by doing so create the conditions of the possibility of a constitutive integral common good that is constituted on the right reasons for allegiance to an overlapping consensus. To conclude with reference to HEPPP, public reason may play an important function with respect to the political common good, even as debates about the weight and meaning of scientific evidence from epidemiology play out in deliberation of ordinary legislation concerning healthy eating. (shrink)

What are the Differences between Public Health Practice and Research? This perplexing question constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance, epidemiological investigations, and evaluation and monitoring. Few debate that these essential public health activities, often specifically authorized (...) by law, are classifiable as public health practice.Other public health activities in which identifiable health data are acquired or used, however, can resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have been inadequately (...) represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

During the COVID-19 pandemic, the Greek authorities enforced a vaccination mandate for healthcare workers (HCWs). At the same time, multiple concerns were raised about the epidemiological profile of Greece in addition to the ethical status of the harsh measures and their impact on employees, organizations, society, and public health. According to the World Health Organization (WHO), considerations regarding the evidence of vaccine safety and effectiveness, necessity, and proportionality should be clearly evaluated by before imposing mandatory vaccination policies. We discuss the (...) issues regarding the mechanics of the transmission and contraction of SARS-CoV-2, the toxicity of COVID-19 vaccines, and the impact of the suspension of HCWs who did not vaccinate versus the potential expected benefits in addition to whether the vaccine mandates were justified considering the overall epidemiological context. (shrink)

This paper extends Alan John Simmons?s conceptual distinction between Lockean and Kantian conceptions of legitimacy that he applied to the question of the legitimacy of states, to the issue of legitimacy of public decisions. I criticise the consent conception of legitimacy defended by Simmons, and I defend the Rawlsian version of the justificatory conception of legitimacy from his objection. The approach of this paper is distinctive because the two conceptions are assessed by investigating, using the method of reflective equilibrium, their (...) respective prescriptions concerning the treatment of antisocial personality disorder and epidemiologic measures. I argue that the method of reflective equilibrium does not support the consent conception. Considering the issues of treatment of APD and of epidemiologic measures, I argue that the consent conception of legitimacy is not well-equipped for the evaluation of norms that are not strictly self-regarding. This causes a deficit of prescriptions for relevant social responses. Further, by considering the case of responses to epidemics, I argue that such a conception can avoid harmful consequences only by recurring to additional, and independent, premises. This does not cause incoherence but reduces the coherence of a normative system. Finally, the consent conception is not equipped to support social cooperation in an optimal way, which has proved to be necessary in critical conditions, like a pandemic. On the other hand, I argue that the method of reflective equilibrium supports the Rawlsian version of justificatory conception of legitimacy, because of its advantages in handling the indicated issues. In addition, I maintain that this justificatory conception is respectful of freedom and equality of agents as moral self-legislators, and, thus, it is not vulnerable to Simmons?s main criticism. (shrink)

BackgroundThere is increasing need for peer reviewers as the scientific literature grows. Formal education in biostatistics and research methodology during residency training is lacking. In this pilot study, we addressed these issues by evaluating a novel method of teaching residents about biostatistics and research methodology using peer review of standardized manuscripts. We hypothesized that mentored peer review would improve resident knowledge and perception of these concepts more than non-mentored peer review, while improving review quality.MethodsA partially blinded, randomized, controlled multi-center study (...) was performed. Seventy-eight neurology residents from nine US neurology programs were randomized to receive mentoring from a local faculty member or not. Within a year, residents reviewed a baseline manuscript and four subsequent manuscripts, all with introduced errors designed to teach fundamental review concepts. In the mentored group, mentors discussed completed reviews with residents. Primary outcome measure was change in knowledge score between pre- and post-tests, measuring epidemiology and biostatistics knowledge. Secondary outcome measures included level of confidence in the use and interpretation of statistical concepts before and after intervention, and RQI score for baseline and final manuscripts.ResultsSixty-four residents (82%) completed initial review with gradual decline in completion on subsequent reviews. Change in primary outcome, the difference between pre- and post-test knowledge scores, did not differ between mentored (−8.5%) and non-mentored (−13.9%) residents (p = 0.48). Significant differences in secondary outcomes (using 5-point Likert scale, 5 = strongly agree) included mentored residents reporting enhanced understanding of research methodology (3.69 vs 2.61; p = 0.001), understanding of manuscripts (3.73 vs 2.87; p = 0.006), and application of study results to clinical practice (3.65 vs 2.78; p = 0.005) compared to non-mentored residents. There was no difference between groups in level of interest in peer review (3.00 vs 3.09; p = 0.72) or the quality of manuscript review assessed by the Review Quality Instrument (RQI) (3.25 vs 3.06; p = 0.50).ConclusionsWe used mentored peer review of standardized manuscripts to teach biostatistics and research methodology and introduce the peer review process to residents. Though knowledge level did not change, mentored residents had enhanced perception in their abilities to understand research methodology and manuscripts and apply study results to clinical practice. (shrink)

Fifty years ago, in 1961, Feinstein published his first path-breaking articles leading to his seminal work Clinical Judgement and to the establishment of clinical epidemiology. Feinstein had an Aristotelian approach to scientific method: methods must be adapted to the material examined. Feinstein died 10 years ago and few years before his death he concluded that efforts to promote a person-oriented medicine had failed. He criticised medicine for not having recognized that only persons can suitably observe, evaluate and rate their (...) own health status. Feinstein’s position was—as in Clinical Judgement—methodological. He didn’t espouse ethical principles. He pointed to methodological deficiencies in clinical epidemiology and evidence-based medicine. In this article we’ll provide a framework for understanding and justifying Feinstein’s call for a person-oriented medicine which recognizes patients as co-actors in clinical reasoning. It’s argued that craftsmanship and practical wisdom are integrated in clinical judgement and reasoning and that clinical reasoning is not only about means to achieve the end, health. We do also reason and deliberate about ends. The ‘defining end’ of medicine (health) has continuously been negotiated and so been the object of deliberation. For centuries among professionals, in recent years among professionals and patients. These negotiations and deliberations lead to ongoing specifications of health as a ‘guiding end’, i.e. an end guiding clinical reasoning about what to do in particular situations. Feinstein’s self-critical account to clinical epidemiology at the end of his professional career reflects the fact that patients during the last 30–40 years (i.e. in the period after the publication of Clinical Judgement) widely have been recognized as persons with rights to autonomy. Feinstein’s lesson is, however, that espousing and recognizing ethical ideals is not enough. A change of clinical practice and its methods is necessary. His critique also implies that clinical epidemiology and evidence-based medicine as practiced haven’t provided such a turn. (shrink)

BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in (...) a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Commentary on “Spiritual Experience and Psychopathology”Andrew Sims (bio)In examining this interesting paper, we need first of all to understand what the authors are doing. They are not taking the conceptual vehicles of “spiritual experience” (SE) and “psychotic phenomena” (PP) for a gentle outing, but exposing both of them to the hardest road test they can devise. From 1,000 accounts of “spiritual experiences” that were already so dramatic that those (...) involved were prepared to describe them, the authors selected three which most successfully blurred the boundaries between SE and PP. So we are not exploring whether these concepts have general practical validity, but whether their mutual frontiers are discrete or overlapping. The authors’ task is legitimate, but it needs to be recognized for what it is.Unusual spiritual experiences are interpreted by the authors as psychotic symptoms, and the definitions of the Present State Examination (PSE) descriptions are cited to justify this. However, we have known for a long time that using instruments for purposes for which they were not designed can produce unexpected results; it is rather like washing socks in a dishwasher and being surprised that it does little good to the socks. The PSE was devised for categorizing and quantifying existing psychiatric disorders in epidemiological studies. The further one gets from this, its true purpose, the less satisfactory it becomes as an instrument. A better way of evaluating symptomatology in an individual case is a skilled and painstaking interview by a well-trained descriptive psychopathologist. One can only conclude from the authors’ use of the PSE in distinguishing SE from PP, that the instrument itself is not capable of doing this, which is not really very surprising. One can form no views on the concepts of SE and PP themselves, except that in some circumstances they may be difficult to tell apart.It would be easy to dispute whether Simon’s beliefs were delusions. Believers from many religious backgrounds “know” that God gives them thoughts or ideas, and it requires detailed psychopathological examination, and not the application of a questionnaire, to distinguish this from the much more concrete experience as described in PSE of “inserted thoughts.”Rating scales, be they assessments of the quality of teaching in primary schools or quantification of established psychotic symptoms, are necessarily only a pale reflection and an over-simplification of the skilled work that professionals undertake. To imply that because a score could be given on the PSE to an otherwise healthy woman who describes the frequent experience of hearing God’s voice, denies the validity of her experience, but also affronts the professional skills of a trained psychopathologist. When psychiatrists, or even [End Page 79] untrained research workers, use the PSE they are presumably doing so as part of an epidemiological research study, and the validity of their individual result is evened out by results from a number of other subjects. If a psychiatrist is trying to decide whether Sara had “true” hallucinations, he or she will carry out a psychopathological interview in which the criteria for establishing true hallucinations are much more sophisticated than is possible in a questionnaire, and the interview will be individualized. Sara’s significant statement, “but God doesn’t take your free will away,” immediately distinguishes her diagnosis from schizophrenia. It was good that Sara’s priest did not need detailed knowledge of psychopathology to come to a common-sense evaluation of her experience.It was with some feelings of disappointment that I realized that when the authors use the word “psychotic” they merely mean that a tick could be placed in an appropriate box for the PSE. If one were to carry out an investigation of serum electrolytes on a fit athlete on completion of a marathon, one would get bizarre and probably abnormal results. For a quantified investigation to be meaningful, one must always take account of the context.When I read these three cases as a psychopathologist, I find no convincing psychotic phenomena, and the three human beings were undoubtedly not psychotic at the time of expression of their religious experiences. The word psychosis is not helpful in psychopathology: if one looks more specifically in these cases for the phenomena... (shrink)

This dissertation explores the ethics of human subjects research with particular attention to how clinical research on vaccines differs from research on therapies. The major differences are rooted in the fact that the benefits of vaccines and vaccine research accrue to the community to which vaccines belong by inducing herd immunity and thereby protecting both vaccinated and unvaccinated individuals. Therapeutics have no corresponding benefit to the community, the primary beneficiary is the individual. The ethical justification for conducting vaccine research in (...) a given community therefore should include an evaluation of the risks and benefits to the community as well as to involved individuals. Respect for individuals extends to respect for communities and for individuals as members of communities. A three way partnership between investigators, the community, and the community members is suggested as an ethical foundation for vaccine research. ;This model is then applied to the particular and complex case of testing a preventive HIV vaccine. HIV is an unique virus which continues to cause extraordinary devastation worldwide. The characteristics of HIV, its transmission and epidemiology, along with unprecedented scientific possibilities present a formidable challenge to the development and testing of an HIV vaccine. Using the community model, specific suggestions are made for the ethical conduct of clinical efficacy trials of HIV preventive vaccines. (shrink)

Those who wish to deny some instance of environmental injustice often attempt to place inappropriate evidentiary burdens on scientists who show disproportionate pollution effects on vulnerable populations. One such evidentiary standard is the epidemiological-evidence rule (EER). According to EER, legitimate causal inferences about pollution-related harm (and actions to reduce probable environmental injustice) require human-epidemiological data, not merely good animal or laboratory data. This article summarizes the grounds for supporting EER, evaluates central scientific problems with EER, assesses key ethical difficulties with (...) EER, then concludes that EER ought not be used either to deny otherwise-probable environmental injustice or to delay possible action to correct well-documented pollution-related harms. (shrink)

The cognitive revolution in psychology was a significant advance in our thinking about the mind. Philosophers and social scientists have looked to the cognitive sciences with the hope that the social world will yield to similar explanatory strategies. Dan Sperber has argued for a programme that would conceptualize the entire domain of anthropological theory in cognitive terms. Sperber's 'epidemiology' specifically excludes interpretive, structuralist and functionalist theories. This essay evaluates Sperber's epidemiological approach to anthropological theory. It argues that as a (...) programme for anthropological theorizing, Sperber's epidemiology could not be empirically grounded. Cognitive explanations depend on prior interpretations. While interpretation is a kind of theorizing, it cannot be assimilated to cognitive explanation. The essay concludes by sketching an explanatory coherence framework in which ethnographic interpretation and cognitive explanation are seen as parts of a unified body of anthropological theorizing. (shrink)

The COVID-19 is creating panic among people around the world and is causing a huge public mental health crisis. Large numbers of observational studies focused on the prevalence of psychological problems during the COVID-19 pandemic were published. It is essential to conduct a meta-analysis of the prevalence of different psychological statuses to insight the psychological reactions of general population during the COVID-19 epidemic in China. Sixty six observational studies about the psychological statuses of people during the COVID-19 were included, searching (...) up to 1 December 2020. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) was used to evaluate the quality of the included studies. OpenMeta[Analyst] was used for the data analysis. High prevalence of acute stress and fear symptoms were observed in the early period of the epidemic. Additionally, anxiety and depression symptoms continued at a high prevalence rate during the epidemic. It should alert the lasting mental health problems and the risk of post-traumatic stress disorder and other mental disorders.Systematic Review Registration:PROSPERO CRD 42020171485. (shrink)

COVID-19 has substantially affected our lives during 2020. Since its beginning, several epidemiological models have been developed to investigate the specific dynamics of the disease. Early COVID-19 epidemiological models were purely statistical, based on a curve-fitting approach, and did not include causal knowledge about the disease. Yet, these models had predictive capacity; thus they were used to ground important political decisions, in virtue of the understanding of the dynamics of the pandemic that they offered. This raises a philosophical question about (...) how purely statistical models can yield understanding, and if so, what the relationship between prediction and understanding in these models is. Drawing on the model that was developed by the Institute of Health Metrics and Evaluation, we argue that early epidemiological models yielded a modality of understanding that we call descriptive understanding, which contrasts with the so-called explanatory understanding which is assumed to be the main form of scientific understanding. We spell out the exact details of how descriptive understanding works, and efficiently yields understanding of the phenomena. Finally, we vindicate the necessity of studying other modalities of understanding that go beyond the conventionally assumed explanatory understanding. (shrink)

The purpose of this study was to evaluate the international scientific output on postpartum depression research during 2000–2020 through a bibliometric analysis and to explore research hotspots, frontiers, and trends in the field of postpartum depression. We searched the Web of Science Core Collection for publications on postpartum depression published between 2000 and 2020. CiteSpace, gCluto, and other software applications were used to analyze the data by year, journal, and country. A total of 2,963 publications were retrieved and 96 countries (...) or regions published related papers. The United States had the largest number of published papers and the highest betweenness centrality, which is the dominant position in the field of postpartum depression. A total of 717 journals published papers, with the Archives of Womens Mental Health ranked first in terms of volume and betweenness centrality. In this study, 31 high-frequency main MeSH terms/subheadings were selected. The high-frequency MeSH terms were clustered into six categories: an overview of depression-related research, diagnostic and screening scales for postpartum depression, epidemiological investigation into postpartum depression, treatment and drug selection for postpartum depression, psychological research on postpartum depression, and etiology, physiopathology, complications, genetics of postpartum depression. Finally, we used strategic diagram to analyze research trends in postpartum depression. This study has identified a continuous significant increase in the publication of PPD articles. Currently, the etiology, physiological pathology, intervention and treatment of complications on PPD are immature, which provides reference for the trend of obstetric psychology. (shrink)

Philosophy of medicine encompasses a broad range of methodological approaches and theoretical perspectives—from the uses of statistical reasoning and probability theory in epidemiology and evidence-based medicine to questions about how to recognize the uniqueness of individual patients in medical humanities, person-centered care, and values-based practice; and from debates about causal ontology to questions of how to cultivate epistemic and moral virtue in practice. Apart from being different ways of thinking about medical practices, do these different philosophical approaches have anything (...) in common? Are they committed to incompatible assumptions about the nature of science and its relationship to experience, value, and the art of medicine, or are different approaches nonetheless complementary? The chapter examines the questions these different approaches and perspectives raise and considers why so many theorists of medicine seek to find a “base” or “center” for medicine—as though there is, or should be, some general conceptual thread linking the things we call “usual clinical practice” in the real world. It further considers whether there are alternative approaches to the philosophy of medicine, which do not embody this philosophical assumption; and it suggests that a key tool for evaluating approaches must be their ability to contribute something of genuine value to clinical medicine. (shrink)

Chagas disease or American trypanosomiasis is an important health problem in Latin America. Due to the mobility of Latin American population around the world, countries without vector presence started to report disease cases. We developed a deterministic compartmental model in order to gain insights into the disease dynamics in a scenario without vector presence, considering congenital transmission and transmission by blood transfusion. The model was used to evaluate the epidemiological effect of control measures. It was applied to demographic data from (...) Spain and sensitivity analysis was performed on model parameters associated with control strategies. (shrink)