The increasing success of the evidence-based policy movement is raising the demand of empirically informed decision making. As arguably any policy decision happens under conditions of uncertainty, following our best available evidence to reduce the uncertainty seems a requirement of good decision making. However, not all the uncertainty faced by decision makers can be resolved by evidence. In this paper, we build on a philosophical analysis of uncertainty to identify the (...) boundaries of scientific advice in policy decision making. We start by introducing a distinction between empirical and non-empirical types of uncertainty, and we explore the role of two non-empirical uncertainties in the context of policy making. We argue that the authority of scientific advisors is limited to empirical uncertainty and cannot extend beyond it. While the appeal of evidence-based policy rests on a view of scientific advice as limited to empirical uncertainty, in practice there is a risk of over reliance on experts beyond the legitimate scope of their authority. We conclude by applying our framework to a real-world case of evidence-based policy, where experts have overstepped their boundaries by ignoring non-empirical types of uncertainty. (shrink)

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

Regarding police procedures with alcohol-intoxicated witnesses, Swedish police officers have previously reported inconsistent and subjective decisions when interviewing these potentially vulnerable witnesses. Most officers have also highlighted the need for national policy guidelines aiding in conducting investigative interviews with intoxicated witnesses. The aims of the two studies presented here were to investigate whether police officers’ inconsistent interview decisions are attributable to a lack of research-based knowledge; their decision to interview, as well as their perceptions of the witnesses’ credibility (...) could be influenced by scientific research; and police officers decision-making and perceptions of witness credibility are biased by pre-existing social norms. In two separate randomized online experiments, police professionals and recruits watched a recorded fictive witness interview to which they were asked to rate the probability of interviewing the witness, the witness’ credibility, and to estimate the witness’ level of intoxication. Results showed that interview probability and perceived witness credibility were affected by witness intoxication level. While it cannot be stated definitely from the present research, these findings provided indications that police officers and recruits lacked research-based knowledge. Results also showed that interview probability, but not perceptions of credibility, was influenced by a research-based message. In line with research, interview probability for the most intoxicated witness increased after reading the message. Unexpectedly, neither interview probability nor witness credibility was affected by social norms. The current findings added to the legal psychology literature by showing that a breath alcohol concentration as low as.04% was enough for police officers and recruits to consider intoxicated witnesses less credible than sober witnesses. Findings also indicated that, despite the lower credibility assessment, police may have some understanding that these witnesses can be interviewed at low intoxication levels. However, this willingness to interview intoxicated witnesses ceased at a BrAC lower than the levels where research has found intoxicated witnesses as reliable as sober witnesses. Future directions for research and policy development as well as theoretical and practical implications of the present findings are discussed. (shrink)

Toward evidence‐based policy decisions: a case study of nursing health human resources in Ontario, CanadaThis paper reflects how health services research ‘evidence’ was used to influence decisions in the province of Ontario, Canada. The process involved interaction among a variety of stakeholders and decision‐makers with researchers to reduce uncertainty and to substantiate emerging service provision issues in the province. The issues presented here focus specifically on an analysis of the nursing situation completed in 1998 for the (...) Minister of Health’s Nursing Task Force, which examined key issues in service delivery. The issues were: restructured work environments; nurse supply and declining enrollments; labour trends and utilization of the nursing workforce; patient acuity and complexity of work environments and the influence on workload; and the paucity of reliable and valid data bases for analysis of nursing’s contribution to the health system. Ontarians can be confident that the Task Force recommendations were born from solid research‐based evidence and now the challenge becomes to monitor the implementation of these resolutions over time. (shrink)

Evidence accumulation has been the core component in recent development of perceptual and value-based decision-making theories. Most studies have focused on the evaluation of evidence between alternative options. What remains largely unknown is the process that prepares evidence: how may the decision-maker sample different sources of information sequentially, if they can only sample one source at a time? Here we propose a normative framework in prescribing how different sources of information should be sampled (...) proactively to facilitate the decision process: beliefs for different noisy sources are updated in a Bayesian manner and participants can proactively allocate resource for sampling (i.e. saccades) among different sources to maximize the information gain in such process. We show that our framework can account for human participants’ actual choice and saccade behaviors in a two-alternative value-based decision-making task. Moreover, our framework makes novel predictions about the empirical eye movement patterns. (shrink)

The evolution of medical reasoning is deeply intertwined with philosophical thought, beginning with Aristotle’s foundational work in deductive logic. Aristotle’s principles significantly influenced early medical practice, shaping the works of Galen and Avicenna, who made empirical observations that expanded clinical knowledge. During the Enlightenment, both inductive reasoning, as advocated by Francis Bacon, and deductive methods, as stressed by René Descartes, significantly advanced medical reasoning. These approaches proved insufficient when it came to handling uncertainty and variability in medical outcomes. Nineteenth-century figures (...) like William Osler advanced a probabilistic understanding of medicine. Karl Popper’s 20th-century hypothetico-deductive method, which introduced the concept of falsifiability and transformed scientific inquiry into a rigorous process of hypothesis testing, is a fundamental aspect of evidence-based medicine (EBM). EBM emerged as the dominant paradigm, combining empirical research, clinical expertise, and statistical inference to guide medical decisions. Looking forward, Bayesian reasoning offers a further refinement in medical reasoning. By incorporating prior knowledge and continuously updating probabilities with new evidence, Bayesianism addresses the limitations of frequentist methods and offers a more dynamic and adaptable framework for clinical decision making. As medical reasoning evolves, understanding this philosophical lineage is essential to navigating the future of patient care, where evidence must be both rigorously tested and individually tailored. (shrink)

Now in its fourth edition, Rational Diagnosis and Treatment: Evidence-Based Clinical Decision - Making is a unique book to look at evidence-based medicine and the difficulty of applying evidence from group studies to individual patients._ The book analyses the successive stages of the decision process and deals with topics such as the examination of the patient,_the reliability of clinical data, the logic of diagnosis, the fallacies of uncontrolled therapeutic experience and the need (...) for randomised clinical trials and meta-analyses. It is the main theme of the book that, whenever possible, clinical decisions must be based on the evidence from clinical research, but the authors also explain the pitfalls of such research and the problems involved in applying evidence from groups of patients to the individual patient._ For this new edition, the sections on placebo and meta-analysis and on alternative medicine have been thoroughly updated, and there is more focus on insufficient reporting of harms of interventions. The sections on different research designs describe advantages and limitations, and the increased medicalisation and the effects of cancer screening on health people are noted. A section on academic freedom when clinicians collaborate with industry and ghost authors is added._ This essential reference work integrates the science and statistical approach of evidence-based medicine with the art and humanism of medical practice; distinguishing between data, sets of data, knowledge and wisdom, and their application. Such an intellectually challenging book is ideal for both medical students and doctors who require theoretical and practical clinical skills to help ensure that they apply theory in practice. (shrink)

The evidence-based turn in education reveals renewed consensus on empiricism and shared trust in science as if it were the allegedly value-free basis for decision-making: good, justifiable governance should be a non-discretional corollary of scientific knowledge. The article focuses on some risks implied in pursuing the de-moralization of educational decision-making, namely the realistic, the reductionist, and the perspective fallacies, as well as the minimization of individual responsibility in favor of the third-person perspective implied in (...) following protocols and guidelines. In the discussion I address some possible reasons for the appeal of the evidence-based turn despite these risks: the contemporary pressure for “accountability” and the need to justify social policies and practices with consensual criteria. In the conclusion, I claim that educational decision-making should deploy rather than conceal its moral bases despite their being potentially highly divisive. Consequently, I make a case for “moral accountability”: making publicly inspectable what evidence-based education tries to conceal, i.e. the unavoidable value-ladeness of educational policies and practices. (shrink)

The use of algorithms to support prediction-based decision-making is becoming commonplace in a range of domains including health, criminal justice, education, social services, lending, and hiring. An assumption governing such decisions is that there is a property Y such that individual a should be allocated resource R by decision-maker D if a is Y. When there is uncertainty about whether a is Y, algorithms may provide valuable decision support by accurately predicting whether a is Y (...) on the basis of known features of a. Based on recent work on statistical evidence in epistemology this article presents an argument against relying exclusively on algorithmic predictions to allocate resources when they provide purely statistical evidence that a is Y. The article then responds to the objection that any evidence that will increase the proportion of correct decisions should be accepted as the basis for allocations regardless of its epistemic deficiency. Finally, some important practical aspects of the conclusion are considered. (shrink)

‘Neuroeconomics’ can be broadly defined as the research of how the brain interacts with the environment to make decisions that are functional given individual and contextual constraints. Deciphering such brain-environment transactions requires mechanistic understandings of the neurobiological processes that implement value-dependent decision making. To this end, a common empirical approach is to investigate neural mechanisms of reward-based decision making. Flexible updating of choices and associated expected outcomes in ways that are adaptive for a given task (...) (or a given set of tasks) at hand relies on dynamic neurochemical tuning of the brain’s functional circuitries involved in the representation of tasks, goals and reward prediction. Empirical evidence as well as computational theories indicate that various neurotransmitter systems (e.g., dopamine, norepinephrine, and serotonin) play important roles in reward-based decision making. In light of the apparent aging-related decline in various aspects of the dopaminergic system as well as the effects of neuromodulation on reward-related processes, this article focuses selectively on the literature that highlights the triadic relations between dopaminergic modulation, reward-based decision making, and aging. Directions for future research on aging and neuroeconomoics are discussed. (shrink)

When is it justified to use opaque artificial intelligence (AI) output in medical decision-making? Consideration of this question is of central importance for the responsible use of opaque machine learning (ML) models, which have been shown to produce accurate and reliable diagnoses, prognoses, and treatment suggestions in medicine. In this article, I discuss the merits of two answers to the question. According to the Explanation View, clinicians must have access to an explanation of why an output was produced. (...) According to the Validation View, it is sufficient that the AI system has been validated using established standards for safety and reliability. I defend the Explanation View against two lines of criticism, and I argue that within the framework of evidence-based medicine mere validation seems insufficient for the use of AI output. I end by characterizing the epistemic responsibility of clinicians and point out how a mere AI output cannot in itself ground a practical conclusion about what to do. (shrink)

AimIn case of extremely rare diseases, case reports are often the only experience to draw from for evidence-based management. Carmi syndrome is a rare, mostly lethal combination of junctional epidermolysis bullosa and pyloric atresia. During an ethical board, there were differences in perception of mortality rate. We tested the hypothesis that the cumulative mortality of single case reports is lower than that of multiple case series.CaseA baby girl was born at 33 weeks gestation with Carmi syndrome. The treatment (...) options discussed in an interdisciplinary ethics board were a palliative approach versus surgical gastrojejunostomy. Because about one third of operated children described in case reports survived, we opted for surgical treatment. The patient died a painful death 4 weeks later.MethodsThe PubMed database was systematically searched for reports of Carmi syndrome. Single case reports were compared to case series in terms of outcome.ResultsA total of 102 cases of Carmi syndrome were identified in the literature. Mortality of single case reports was 17 out of 27 patients (63%), while that of case series was higher at 62 out of 74 patients (84%,p = 0.036).ConclusionsSelection and publication bias may lead to inflation of survival rates in single case reports because successful cases are more likely to be published in the literature. These biases may lead to inappropriately aggressive treatment in futile cases. Clinicians should be cautious when discussing prognosis and making decisions based on the cumulative experience of case reports of extremely rare or novel diseases. (shrink)

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

In this paper we introduce a formalism for single-agent decision making that is based on Dynamic Argumentation Frameworks. The formalism can be used to justify a choice, which is based on the current situation the agent is involved. Taking advantage of the inference mechanism of the argumentation formalism, it is possible to consider preference relations, and conflicts among the available alternatives for that reasoning. With this formalization, given a particular set of evidence, the justified conclusions (...) supported by warranted arguments will be used by the agent’s decision rules to determine which alternatives will be selected. We also present an algorithm that implements a choice function based on our formalization. Finally, we complete our presentation by introducing formal results that relate the proposed framework with approaches of classical decision theory. (shrink)

Evidence-based policy-making (EBP) is widely seen as a key instrument for good policy-making. Yet in the wake of the Covid-19 pandemic, the debate on the relation of science and policy-making gained new momentum. The premises of EBP, its narrow understanding of what kind of knowledge counts and how to make decisions, appeared inapt to provide a sound foundation for policy-making under conditions of high complexity and uncertainty. This paper addresses the major shortcomings of EBP (...) and argues for revising its evidentialist framework. First, the idea of evidence itself has to be extended and pluralized by including alternative forms of knowledge. Second, uncertainty has to be taken seriously as a fundamental epistemic condition. To arrive at a more apt model of policy-making, this paper suggests to adopt a pragmatist perspective on the relation of politics, science and the public. This leads to an experimentalist account in the meliorist spirit. Such an account highlights the role of experience, participatory processes and collective learning. Furthermore, and in contrast to scientistic models, it underlines political responsibility and demands to cultivate sensitivity for possible failures and tragic constellations. Finally, a non-evidentialist model of policy advice is outlined. (shrink)

BackgroundInformed consent is a key element of ethical clinical research. Addicted population may be at risk for impaired consent capacity. However, very little research has focused on their comprehension of consent forms. The aim of this study is to assess the capacity of addicted individuals to provide consent to research.Methods53 subjects with DSM-5 diagnoses of a Substance Use Disorder and 50 non psychiatric comparison subjects participated in the survey from December 2014 to March 2015. This cross-sectional study was carried out (...) at a community-based Outpatient Treatment Center and at an urban-located Health Centre in Spain. A binary judgment of capacity/incapacity was made guided by the MacArthur Competence Assessment Tool for Clinical Research and a clinical interview. Demographics and clinical characteristics were assessed by cases notes and the Mini-Mental State Examination, the Global Assessment Functional Scale and the Clinical Global Impression Scale.ResultsNPCs performed the best on the MacCAT–CR, and patients with SUD had the worst performance, particularly on the Understanding and Appreciation subscales. 32.7 % SUD people lacked research-related decisional capacity. There were no statistically significant differences between the groups in terms of capacity to consent to research.ConclusionsThe findings of our study provide evidence that a large proportion of individuals with SUD had decisional capacity for consent to research. It is therefore inappropriate to draw conclusions about capacity to make research decisions on the basis of a SUD diagnosis. In the absence of advanced cognitive impairment, acute withdrawal or intoxication, we should assume that addicted persons possess decision-making capacity. Thus, the view that people with SUD would ipso facto lose decision-making power for research consent is flawed and stigmatizing. (shrink)

Background Advance healthcare decision-making presumes that a prior treatment preference expressed with sufficient mental capacity (“T1 preference”) should trump a contrary preference expressed after significant cognitive decline (“T2 preference”). This assumption is much debated in normative bioethics, but little is known about lay judgments in this domain. This study investigated participants’ judgments about which preference should be followed, and whether these judgments differed depending on a first-person (deciding for one’s future self) versus third-person (deciding for a friend or (...) stranger) perspective. -/- Methods A vignette-based survey was conducted (N = 1445 US Americans; gender-balanced sample), in a 3 (relationship: self, best friend, stranger) × 2 (T1 preference: treat, do not treat) × 2 (T2 contrary preference: ambiguous, unambiguous) design. -/- Results Participants were more likely to defer to the incapacitated T2 preference of a third-party, while being more likely to insist on following their own T1 capacitated preference. Further, participants were more likely to conclude that others with substantial cognitive decline were still their “true selves,” which correlated with increased deference to their T2 preferences. -/- Conclusions These findings add to the growing evidence that lay intuitions concerning the ethical entitlement to have decisions respected are not only a function of cognition, as would be expected under many traditional bioethical accounts, but also depend on the relationship of the decision to the decision-maker’s true self. (shrink)

Methodological strategies for the identification and synthesis of ‘evidence’ to support decision‐making in relation to complex healthcare systems and practices This paper addresses the limitations of current methods supporting ‘evidence‐based health‐care’ in relation to complex aspects of care, including those questions that are best supported by descriptive or non‐empirical evidence. The paper identifies some new methods, which may be useful in aiding the synthesis of data in these areas. The methods detailed are broadly divided (...) into those that facilitate the identification of evidence and those that enable the interpretation of the data retrieved. To illustrate some of the issues involved, reference is made to a multimethod review recently completed by the authors, which aimed to identify factors that promote continuity in the transition from child to adult health and social care. It is argued that as healthcare organisations are becoming increasingly preoccupied with the evidence base of practice, such methods may help ensure that aspects of care and approaches that are outside the dominant pharmaco‐medical domain maintain a prominent position on the healthcare agenda while remaining open to external scrutiny. Healthcare professionals who use such approaches need to know their relative utility and benefits to inform clinical decisions, so as to ensure that best practice is observed. (shrink)

Evidence-based approaches to policy-making are growing in popularity. A generally embraced view is that with the appropriate evidence at hand, decision and policy making will be optimal, legitimate and publicly accountable. In practice, however, evidence-based policy making is constrained by a variety of problems of evidence. Some of these problems will be explored in this article, in the context of the debates on evidence from which they originate. It is (...) argued that the source of much disagreement might be a failure to addressing crucial philosophical assumptions that inform, often silently, these debates. Three controversial questions will be raised which appear central to some of the challenges faced by evidence-based policy making: firstly, how do certain types of facts candidate themselves as evidence; secondly, how do we decide what evidence we have, and how much of it; and thirdly, can we combine evidence. In addressing these questions it will be shown how a philosophically informed debate might prove instrumental in clarifying and settling practical difficulties. (shrink)

Background The world literature shows that empirical research regarding the process of decision-making when cancer in adolescents is no longer curable has been conducted in High-income, English speaking countries. The objective of the current study was to explore in-depth and to explain the decision-making process from the perspective of Mexican oncologists, parents, and affected adolescents and to identify the ethical principles that guide such decision-making. Methods Purposive, qualitative design based on individual, fact-to-face, semi-structured, (...) in-depth interviews. The participants were thirteen paediatric oncologists, 13 parents or primary carers, and six adolescents with incurable cancer. The participants were recruited from the paediatric oncology services of three national tertiary-care medical centres in Mexico City. Results The oncologists stated that they broach the subject of palliative management when they have determined that curative treatment has failed. Respect for autonomy was understood as the assent of the parent/adolescent to what the oncologist determined to be in the best interest of the adolescent. The oncologists thought that the adolescent should be involved in the decision-making. They also identified the ability to count on a palliative care clinic or service as an urgent need. For the parents, it was essential that the oncologist be truly interested in their adolescent child. The parents did not consider it necessary to inform the child about impending death. The adolescents stated that the honesty of their oncologists was important; however, several of them opted for a passive role in the decision-making process. Conclusion The findings of this study evidence that to achieve good medical practice in low-middle income countries, like Mexico, it is urgent to begin effective implementation of palliative care, together with appropriate training and continuing education in the ethics of clinical practice. (shrink)

Evidence-Based Medicine (EBM) is defined as the conscious, and judicious use of current best evidence in making decisions about the care of individual patients. The greater the level of evidence the greater the grade of recommendation. This pioneering explicit concept of EBM is embedded in a particular view of medical practice namely the singular nature of the patient-physician relation and the commitment of the latter towards a specific goal: the treatment and the well being of (...) his or her client. Nevertheless, in many European countries as well as the United States, this integration of the best evidence from systematic research with clinical expertise and patient values appears to be re-interpreted in light of the scarcity of healthcare resources. The purpose of this paper is double. First, to claim that from an ethical perspective EBM should be a guideline to clinical practice; and second, that in specific circumstances EBM might be a useful tool in macro-allocation of healthcare resources. Methodologically the author follows Norman Daniels' theory of democratic accountability to justify this assumption. That is, choices in healthcare must be accountable by democratic procedures. This perspective of distributive justice is responsible for the scope and limits of healthcare services. It follows that particular entitlements to healthcare — namely expensive innovative treatments and medicines —may be fairly restricted as long as this decision is socially and democratically accountable and imposed by financial restrictions of the system. In conclusion, the implementation of EBM, as long as it limits the access to drugs and treatments of unproven scientific results is in accordance with this perspective. The use of EBM is regarded as an instrument to facilitate the access of all citizens to a reasonable level of healthcare and to promote the efficiency of the system. (shrink)

This paper challenges the traditional assumption that descriptive and prescriptive sciences are essentially distinct by presenting a study on the implicit normativity of the production and presentation of biomedical scientific facts within evidence-based medicine. This interdisciplinary study serves as an illustration of the potential worth of the concept of implicit normativity for bioethics in general and for integrated empirical ethics research in particular. It demonstrates how both the production and presentation of scientific information in an evidence-based (...) decision-support contain implicit presuppositions and values, which pre-structure the moral environment of the clinical process of decision-making. As a consequence, the evidence-based decision support did not only support the clinical decision-making process; it also transformed it in a morally significant way. This phenomenon undermines the assumption within much of the literature on patient autonomy that information disclosure is a conditional requirement before patient autonomy even starts; patient autonomy is already influenced during the production and presentation of information. These results imply an increased responsibility of those who produce and present evidence-based facts(i.e. scientists in general and physicians in particular). The insights of this study not only involve a different focus on both theory and practice of patient autonomy and informed consent, but they also call for a broader scope of morality than does traditional empirical research in bioethics. The concept of implicit normativity within integrated empirical ethics research calls for a strong cooperation between bioethicists and descriptive scientists, i.e., a cooperation that goes beyond the discipline-specific epistemic values and that takes place during all phases of the research process. (shrink)

In this paper we argue for a naturalistic solution to some of the methodological controversies in regulatory science, on the basis of two case studies: toxicology and health claim regulation. We analyze the debates related to the scientific evidence that is considered necessary for regulatory decision making in each of those two fields, with a particular attention to the interactions between scientific and regulatory aspects. This analysis allows us to identify two general stances in the debate: a) (...) one that argues for more permissive standards of evidence and for methodological pluralism, and b) an opposing one that not only defends strict evidence requirements but also stipulates the use of one particular scientific methodologies for data generation. We argue that the real-world outcomes produced by alternative regulatory options are a vital piece of information that allows for the empirical assessment of these two stances. In particular, this information on outcomes makes it possible to analyze which standards of evidence and scientific methods generate the most useful knowledge as input for regulatory decision making. Our conclusion is that instead of an a priori selection of methodologies and standards, such decisions ought to be based on empirical evidence related to real-world outcomes. (shrink)

Thomas, Bracken, and Timimi (2012) make an important contribution in critiquing the extent to which the profession of psychiatry can be so bureaucratic that patients are treated as problems to be solved in an ‘efficient’ assembly line fashion rather than as individual persons. The trouble with bureaucracies is that they promote a cold and impersonal accounting approach in which critical reflection on purposes is circumvented by decision-making algorithms (Zachar and Bartlett 2009). Psychotherapy treatment manuals definitely satisfy the bureaucratic (...) instinct, and the fifteen-minute medication management session even more so (Harris 2011). Ideally, evidence-based medicine (EBM) should be used to promote the goals of .. (shrink)

Over the past decades, great strides have been made to professionalize and increase access to transgender medicine. As the evidence base grows and conceptualizations regarding gender dysphoria/gender incongruence evolve, so too do ideas regarding what constitutes good treatment and decision-making in transgender healthcare. Against this background, differing care models arose, including the ‘Standards of Care’ and the so-called ‘Informed Consent Model’. In these care models, ethical notions and principles such as ‘decision-making’ and ‘autonomy’ are often (...) referred to, but left unsubstantiated. This not only transpires into the consultation room where stakeholders are confronted with many different ethical challenges in decision-making, but also hampers a more explicit discussion of what good decision-making in transgender medicine should be comprised of. The aim of this paper is to make explicit the conceptual and normative assumptions regarding decision-making and client autonomy underpinning the ‘Standards of Care’ and ‘Informed Consent Model’ currently used in transgender care. Furthermore, we illustrate how this elucidation aids in better understanding stakeholders’ ethical challenges related to decision-making. Our ethical analysis lays bare how distinct normative ambiguities in both care models influence decision-making in practice and how foregrounding one normative model for decision-making is no moral panacea. We suggest that the first steps towards good decision-making in gender-affirming medical care are the acknowledgement of its inherent normative and moral dimensions and a shared, dialogical approach towards the decision-making process. (shrink)

BackgroundSystems medicine is the name for an assemblage of scientific strategies and practices that include bioinformatics approaches to human biology ; “big data” statistical analysis; and medical informatics tools. Whereas personalized and precision medicine involve similar analytical methods applied to genomic and medical record data, systems medicine draws on these as well as other sources of data. Given this distinction, the clinical translation of systems medicine poses a number of important ethical and epistemological challenges for researchers working to generate systems (...) medicine knowledge and clinicians working to apply it.DiscussionThis article focuses on three key challenges: First, we will discuss the conflicts in decision-making that can arise when healthcare providers committed to principles of experimental medicine or evidence-based medicine encounter individualized recommendations derived from computer algorithms. We will explore in particular whether controlled experiments, such as comparative effectiveness trials, should mediate the translation of systems medicine, or if instead individualized findings generated through “big data” approaches can be applied directly in clinical decision-making. Second, we will examine the case of the Riyadh Intensive Care Program Mortality Prediction Algorithm, pejoratively referred to as the “death computer,” to demonstrate the ethical challenges that can arise when big-data-driven scoring systems are applied in clinical contexts. We argue that the uncritical use of predictive clinical algorithms, including those envisioned for systems medicine, challenge basic understandings of the doctor-patient relationship. Third, we will build on the recent discourse on secondary findings in genomics and imaging to draw attention to the important implications of secondary findings derived from the joint analysis of data from diverse sources, including data recorded by patients in an attempt to realize their “quantified self.”SummaryThis paper examines possible ethical challenges that are likely to be raised as systems medicine to be translated into clinical medicine. These include the epistemological challenges for clinical decision-making, the use of scoring systems optimized by big data techniques and the risk that incidental and secondary findings will significantly increase. While some ethical implications remain still hypothetical we should use the opportunity to prospectively identify challenges to avoid making foreseeable mistakes when systems medicine inevitably arrives in routine care. (shrink)

A discussion of ethical decision-making literature is overdue. In this article, we summarize the current literature of ethical decision-making models used in mental health professions. Of 1,520 articles published between 2001 and 2020 that met initial search criteria, 38 articles were included. We report on the status of empirical evidence for the use of these models along with comparisons, limitations, and considerations. Ethical decision-making models were synthesized into eight core procedural components and presented (...) based on the composition of steps present in each model. This taxonomy provides practitioners, trainers, students, and supervisors relevant information regarding ethical decision-making models. (shrink)

Evidence-based medicine frequently uses statistical hypothesis testing. In this paradigm, data can only disconfirm a research hypothesis’ competitors: One tests the negation of a statistical hypothesis that is supposed to correspond to the research hypothesis. In practice, these hypotheses are often misaligned. For instance, directional research hypotheses are often paired with non-directional statistical hypotheses. Prima facie, one cannot gain proper evidence for one’s research hypothesis employing a misaligned statistical hypothesis. This paper sheds lights on the nature of (...) and the reasons for such misalignments and it provides a thorough analysis of whether they pose a threat to evidence-based medicine. The upshots are that the misalignments are often hidden for clinicians and that although some cases of misalignments can be partially counterbalanced, the overall threat is non-negligible. The counterbalances either lead to methodological inadequacy, loss of statistical power, or involve a lack of information that could be crucial for decision making. This result casts doubt on various findings of medical studies in addition to issues associated with under-powered studies or the replication crisis. (shrink)

Despite the entrenched acceptance of normal science in health care, it appears that authoritative, positivist, linear, risk averse, certainty-based thinking can only get us so far along the route of optimum health. This paper examines labor and childbirth as a paradigm case of a complex adaptive system (CAS) and offers the example of techniques used in a master-level course on normal childbirth to illustrate how maternity care clinicians can be introduced to complexity-based thinking through reflexive analysis of real (...) life clinical narratives. It suggests that these techniques might be used as a basis for answering the question, what is likely to work for this person, in this situation, given the range of evidence, and given their values and beliefs, my values and beliefs, and my clinical skills and knowledge? Topics discussed in this paper include complexity, pregnancy, and childbirth; mainstreaming complexity-focused decision making in maternity care; and using story in practice. In conclusion, complexity theory appears to offer a good explanatory model for pregnancy and childbirth, both in general, and for specific individuals. Future work in this area should examine the efficacy and limits to formal story telling in maternity care, with the aim of increasing optimal maternity care for mothers and babies, and for the staff and organizations that deliver the care. (PsycINFO Database Record (c) 2010 APA, all rights reserved). (shrink)

Public policymakers and institutional decision-makers routinely face questions about whether interventions “work”: does universal basic income improve people’s welfare and stimulate entrepreneurial activity? Do gated alleyways reduce burglaries or merely shift the crime burden to neighbouring communities? What is the most cost-effective way to improve students’ reading abilities? These are empirical questions that seem best answered by looking at the world, rather than trusting speculations about what will be effective. Evidence-based policy (EBP) is a movement that concretizes (...) this intuition. It maintains that policy should be based on evidence of “what works.” Not any evidence will do, however. Following on the heels of its intellectual progenitor, evidence-based medicine (EBM), EBP insists on the use of high-quality evidence produced in accordance with rigorous methodological standards. Though intuitively compelling, EBP has attracted significant criticism from methodologists, political scientists, and philosophers. This chapter provides a critical overview of EBP through a philosophical lens, reviewing and discussing some of the most pressing challenges that EBP faces and outlining some proposals for improving it. I first provide a brief overview of EBP and distinguish a broader and narrower understanding of it. I then review existing lines of criticism of EBP, two of which are considered in detail. The first elaborates how EBP struggles with extrapolation, that is, the use of evidence from study populations to make inferences about the effects of policies on novel target populations. The second maintains that EBP’s methodological tenets are deeply entwined with moral and political values, which can threaten EBP’s promise to promote objectivity in policymaking. Finally, I make some proposals for how EBP could be improved going forward. (shrink)

Background The increase in empirical methods of research in bioethics over the last two decades is typically perceived as a welcomed broadening of the discipline, with increased integration of social and life scientists into the field and ethics consultants into the clinical setting, however it also represents a loss of confidence in the typical normative and analytic methods of bioethics. Discussion The recent incipiency of "Evidence-Based Ethics" attests to this phenomenon and should be rejected as a solution to (...) the current ambivalence toward the normative resolution of moral problems in a pluralistic society. While "evidence-based" is typically read in medicine and other life and social sciences as the empirically-adequate standard of reasonable practice and a means for increasing certainty, I propose that the evidence-based movement in fact gains consensus by displacing normative discourse with aggregate or statistically-derived empirical evidence as the "bottom line". Therefore, along with wavering on the fact/value distinction, evidence-based ethics threatens bioethics' normative mandate. The appeal of the evidence-based approach is that it offers a means of negotiating the demands of moral pluralism. Rather than appealing to explicit values that are likely not shared by all, "the evidence" is proposed to adjudicate between competing claims. Quantified measures are notably more "neutral" and democratic than liberal markers like "species normal functioning". Yet the positivist notion that claims stand or fall in light of the evidence is untenable; furthermore, the legacy of positivism entails the quieting of empirically non-verifiable considerations like moral claims and judgments. As a result, evidence-based ethics proposes to operate with the implicit normativity that accompanies the production and presentation of all biomedical and scientific facts unchecked. Summary The "empirical turn" in bioethics signals a need for reconsideration of the methods used for moral evaluation and resolution, however the options should not include obscuring normative content by seemingly neutral technical measure. (shrink)

The focus of this paper is the moral and scientific value of ‘expertise by experience’, that is, knowledge based on personal experience of ill mental health as a form of expertise in mental health research. In contrast to individualistic theories of personal autonomy and the first-person in bioethics, my account of shared decision-making is focussed on how a relational approach to the ‘person’ and ‘patient values’ can throw new light on our understanding of ‘voice’ in mental health (...) research. The mistake, I argue, is to think that a commitment to listening to the patient voice in the process of perspective taking implies a threat to ‘objectivity’ in clinical practice and the very concept of evidence in the philosophy of science more generally. Instead, I use Helen Longino's account of epistemic validity in philosophy of science to argue that narrative experience and ‘patient perspective’ should be understood as an ongoing dynamic partnership working between the different stakeholders’ knowledge perspectives. I also address the connection between expertise by experience and the psychiatric significance of the personal self for the entrenched topics of agency, self-hood, personal identity, and self-knowledge in psychiatric diagnosis. In contrast to identity politics, my model of shared decision-making preserves a critical distance between perspective-taking and value itself in self/other appraisal as the gold standard for good clinical practice. (shrink)

Shared decision-making involves health professionals and patients/clients working together to achieve true person-centred health care. However, this goal is infrequently realized, and most barriers are unknown. Discussion between philosophers, clinicians, and researchers can assist in confronting the epistemic and moral basis of health care, with benefits to all. The aim of this paper is to describe what shared decision-making is, discuss its necessary conditions, and develop a definition that can be used in practice to support excellence (...) in maternity care. Discussion between the authors, with backgrounds in philosophy, clinical maternity care, health care management, and maternity care research, assisted the team to confront established norms in maternity care and challenge the epistemic and moral basis of decision-making for caesarean section. The team concluded that shared decision-making must start in pregnancy and continue throughout labour and birth, with equality in discourse facilitated by the clinician. Clinicians have a duty of care for the adequacy of women's knowledge, which can only be fulfilled when relevant knowledge is offered freely and when personal beliefs and biases that may impinge on decision-making (defeaters) are disclosed. Informed consent is not shared decision-making. Key barriers include existing cultural norms of “the doctor knows best” and “patient acquiescence” that prevent defeaters being acknowledged and discussed and can lead to legal challenges, overuse of medical intervention and, in some areas, obstetric violence. Shared decision-making in maternity care can thus be defined as an enquiry by clinician and expectant woman aimed at deciding upon a course of care or none, which takes the form of a dialogue within which the clinician fulfils their duty of care to the client's knowledge by making available their complete knowledge (based on all types of evidence) and expertise, including an exposition of any relevant and recognized potential defeaters. Research to develop measurement tools is required. (shrink)

Proponents of Evidence-based medicine (EBM) do not provide a clear role for basic science in therapeutic decision making. Of what they do say about basic science, most of it is negative. Basic science resides on the lower tiers of EBM's hierarchy of evidence. Therapeutic decisions, according to proponents of EBM, should be informed by evidence from randomised studies (and systematic reviews of randomised studies) rather than basic science. A framework of models explicates the links (...) between the mechanisms of basic science, experimental inquiry, and observed data. Relying on the framework of models I show that basic science often plays a role not only in specifying experiments, but also analysing and interpreting the data that is provided. Further, and contradicting what is implied in EBM's hierarchy of evidence, appeals to basic science are often required to apply clinical research to therapeutic questions. © 2010 Springer Science+Business Media B.V. (shrink)

The aim of this article is to explore the complex forms of knowledge involved in diagnostic and interventional decision making by comparing the processes in medicine and nursing, including nurse practitioners. Many authors assert that the practice of clinical decision making involves the application of theoretical knowledge (acquired in the classroom and textbooks) as well as research evidence, upon concrete particular cases. This approach draws on various universal principles and algorithms to facilitate the task. On (...) the other hand, others argue that this involves an intuitive form of judgement that is difficult to teach, one that is acquired principally through experience. In an exploration of these issues, this article consists of three sections. A clarification of terms commonly used when discussing decision making is provided in the first section. In the second section, an epistemological analysis of decision making is presented by examining several perspectives and comparing them for their use in the nursing and medical literature. Bunge's epistemological framework for decision making (based on scientific realism) is explored for its fit with the aims of medicine and nursing. The final section presents a discussion of knowledge utilization and decision making as it relates to the implications for the education and ongoing development of nurse practitioners. It is concluded that Donald Schön's conception of reflective practice best characterizes the skilful conduct of clinical decision making. (shrink)

While most of healthcare research and practice fully endorses evidence-based healthcare, a minority view borrows popular themes from philosophy of science like underdetermination and value-ladenness to question the legitimacy of the evidence-based movement’s philosophical underpinnings. While the feminist origins go unacknowledged, those critics adopt a feminist reading of the “gap argument” to challenge the perceived objectivism of evidence-based practice. From there, the critics seem to despair over the “subjective elements” that values introduce to clinical (...) reasoning, demonstrating that they do not subscribe to feminist science studies’ normative program——where contextual values can enable good science and justified decisions. In this paper, I investigate why it is that the critics of evidence-based medicine adopt feminist science’s characterization of the problem but resist the productive solutions offered by those same theorists. I suggest that the common feminist empiricist appeal to idealized epistemic communities is impractical for those working within the current biomedical context and instead offer an alternate stream of feminist research into the empirical content of values (found in the work of Elizabeth Anderson and Sharyn Clough) as a more helpful recourse for facilitating the important task of legitimate and justified clinical decision-making. I use a case study on clinical decision-making to illustrate the fruitfulness of the latter feminist empiricist framework. -/- See response by Sharyn Clough: http://wp.me/p1Bfg0-1aN See reply by Maya Goldenberg: http://wp.me/p1Bfg0-1oY. (shrink)