Background In 2001 a report on the provision of clinical ethics support in UK healthcare institutions identified 20 clinical ethics committees. Since then there has been no systematic evaluation or documentation of their work at a national level. Recent national surveys of clinical ethics services in other countries have identified wide variation in practice and scope of activities. Objective To describe the current provision of ethics support in the UK and its development since 2001. Method A postal/electronic questionnaire survey administered (...) to the chairs of all 82 clinical ethics services registered with the UK Clinical Ethics Network in July 2010. Results Response rate was 62% with the majority of responding services situated in acute trusts. All services included a clinical ethics committee with one service also having a clinical ethicist. Lay members were present in 72% of responding committees. Individual case consultation has increased since 2001 with 29% of chairs spending more than 50% of their time on this. Access to and involvement in the process of case consultation is less for patients and families than for clinical staff. There is wide variation in committee processes and levels of institutional support. Over half of the responding committees undertook some form of evaluation. Conclusion Clinical ethics services in the UK are increasing as is their involvement in case consultation. However, the significant variation in committee processes suggests that further qualitative research is needed to understand how these committees function and the role they play in their institution. (shrink)

Patient-reported outcome measures (PROMs) are increasingly used to assess multiple facets of healthcare, including effectiveness, side effects of treatment, symptoms, health care needs, quality of care, and the evaluation of health care options. There are thousands of these measures and yet there is very little discussion of their theoretical underpinnings. In her 2008 Presidential address to the Society for Quality of Life Research (ISOQoL), Professor Donna Lamping challenged researchers to grapple with the theoretical issues that arise from these measures. In (...) this paper, I attempt to do so by arguing for an analogy between PROMs and Hans-Georg Gadamer’s logic of question and answer. While researchers readily admit that the constructs involved in PROMs are imperfectly understood and lack a gold standard, they often ignore the consequences of this fact. Gadamer’s work on questions and their importance to philosophical hermeneutics helps to show that the questions researchers ask about such constructs are also imperfectly understood. I argue that these questions should not be standardized, and I instead propose a theoretical framework that understands PROMs as posing genuine questions to respondents—questions that are open to reinterpretation. (shrink)

Philosophers and others have questioned whether or not expertise in morality is possible. This debate is not only theoretical, but also affects the perceived legitimacy of clinical ethicists. One argument against moral expertise is that in a pluralistic society with competing moral theories no one can claim expertise regarding what another ought morally to do. There are simply too many reasonable moral values and intuitions that affect theory choice and its application; expertise is epistemically uniform. In this article, we discuss (...) how similar concerns have recently threatened to undermine expertise in medicine and science. In contrast, we argue that the application of values is needed to exercise medical, scientific, and moral expertise. As long as these values are made explicit, worries about a pretense to authority in the context of a liberal democracy are ill-conceived. In conclusion, we argue for an expertise that is epistemically diverse. (shrink)

Health-related quality of life measures aim to assess patients’ subjective experience in order to gauge an increasingly wide variety of health care issues such as patient needs; satisfaction; side effects; quality of care; disease progression and cost effectiveness. Their popularity is undoubtedly due to a larger initiative to provide patient-centered care. The use of patient perspectives to guide health care improvements and spending is rooted in the idea that we must respect patients as self-determining agents. In this paper I look (...) at the two main orientations to quality of life measurement: standardized and individualized measures. I argue that while these measures are attempts to provide for patient self-determination, they both fail to do so. In their place I suggest a new approach which overcomes their respective difficulties: a dialogic approach. (shrink)

ObjectivesTo explore the objectives and outcomes most appropriate for evaluating clinical ethics support services (CESs) in the USA.MethodsA three-round e-Delphi was sent to two professional medical ethics listservs (Medical College of Wisconsin-Bioethics and American Society for Bioethics and Humanities) as well as 19 individual experts. The survey originally contained 15 objectives and 9 outcomes. In round 1, participants were asked to validate the content of these lists. In round 2, we had 17 objectives and 10 outcomes, and participants were asked (...) to rank them for appropriateness in a top 10 list of objectives and a top 5 list of outcomes.ResultsParticipants came to a high(at least 70%) level of agreement on seven objectives: mediate, educate, develop policy, improve the moral quality of a decision or action, counsel, create a moral space and manage moral distress. Participants came to a moderate (at least 51%) level of agreement on three objectives: empower, awareness of ethics and preventative ethics. Participants also came to a moderate (at least 51%) level of agreement on five outcomes: ethical justification, transformation of institution, improvement of quality of life, principled consensus and satisfaction with the expertise of a CES.ConclusionThis e-Delphi identified 10 objectives and 5 outcomes that are a good starting point for developing outcome measures to evaluate CESs in the USA, while reminding us of the diversity of perspectives still evident in the field. (shrink)

Patient-reported outcomes are increasingly used as dependent variables in studies regarding the effectiveness of clinical interventions. But patient-reported outcome measures (PROMs) do not provide intuitively meaningful data. For instance, it is not clear what a five point increase or decrease on a particular scale signifies. Establishing ‘interpretability’ involves making changes in outcomes meaningful. Attempts to interpret PROMs have led to the development of methods for identifying a minimum important difference (MID). In this paper, however, I draw on Charles Taylor’s distinction (...) between weak and strong evaluations to suggest that identifying a MID, specifically, a MID that uses a patient-reported reference group, may not provide an adequate interpretation of these measures. Moreover, I argue that the difficulty with interpreting these measures is tied to a larger problem concerning their validity. If researchers wish to interpret PROMs, they may first need to know more about the constructs they attempt to measure, namely, quality of life. (shrink)

Twelve years ago the British media got wind of a London gynecologist who performed an elective reduction on a twin pregnancy reducing it to a singleton. Perhaps not surprisingly, opinion on the moral status of twin reductions was divided. But in the last few years new evidence regarding the medical risks of twin pregnancies has emerged, suggesting that twin reductions are relevantly similar to the reductions performed on high‐end multi‐fetal pregnancies. This evidence has appeared to resolve the moral debate.In this (...) paper I look at the role of clinical evidence in medical ethics. In particular I examine the role of clinical evidence in determining what counts as a significant harm or risk. First, I challenge the extent to which these empirical claims are descriptive, suggesting instead that the evidence is to some degree normative in character. Second, I question whether such empirical claims should count as evidence for what are essentially difficult ethical decisions – a role they appear to play in the case of elective reductions. I will argue that they should not, primarily because the value‐laden nature of this evidence conceals much of what is ethically at stake. It is important to recognize that empirical evidence cannot be a substitute for ethical deliberation. (shrink)

Failings in patient care and quality in NHS Trusts have become a recurring theme over the past few years. In this paper, we examine the Care Quality Commission’s Guidance about Compliance: Essential Standards of Quality and Safety and ask how NHS Trusts might be better supported in fulfilling the regulations specified therein. We argue that clinical ethics committees (CECs) have a role to play in this regard. We make this argument by attending to the many ethical elements that are highlighted (...) in the Commission’s Regulations and by providing practical examples of how CECs can (and in some case already do) provide ethics support to health professionals and trusts. Although CECs have been traditionally associated with case consultation, i.e., discrete problems caused by individual circumstances, in the previous 10 years the literature suggests that clinical ethics services have become more integrated into the life of the health care organization and are increasing construed as proactive agents of systematic change. We provide evidence from a recent survey of UK clinical ethics services that this trend is present in the UK. (shrink)

Quality improvement mechanisms increasingly use outcome measures to evaluate health care providers. This move toward outcome measures is a radical departure from the traditional focus on process measures. More radical still is the proposal to shift from relatively simple and proximal measures of outcome, such as mortality, to complex outcomes, such as quality of life. While the practical, scientific, and ethical issues associated with the use of outcomes such as mortality and morbidity to compare health care providers have been well (...) rehearsed, the specific concerns associated with the use of quality of life measures in quality of care research have received little attention. As with much research on quality of life there is a tendency to assume that the disadvantages are outweighed by the general virtue of “listening” to patients. In this paper we disagree with this assumption and argue that quality of life is a process, not an outcome. (shrink)

There has been much philosophical interest regarding the ‘hierarchy of evidence’ used to determine which study designs are of most value for reporting on questions of effectiveness, prognosis, and so on. There has been much less philosophical interest in the choice of outcome measures with which the results of, say, an RCT or a cohort study are presented. In this paper, we examine the FDA’s recently published guidelines for assessing the psychometric adequacy of patient-reported outcome measures. We focus on their (...) recommendations for demonstrating content validity and also for how researchers should weigh up the sum of psychometric evidence when choosing these measures. We argue that questions regarding judgment and understanding meaning of these measures should play a more central role in determining their adequacy. (shrink)

Since the 1970’s epidemiological measures focusing on “health-related quality of life” or simply “quality of life” have figured increasingly as endpoints in clinical trials. Before the 1970’s these measures were known, generically, as performance measures or health status measures. Relabeled as “quality of life measures” they were first used in cancer trials. In the early 2000’s they were relabeled again as “patient-reported outcome measures” or PROMs, in their service to the FDA to support drug labeling claims. To the limited degree (...) that the philosophical literature addresses these measures, it tends to associate them with two major theories of well-being: subjective well-being and the capabilities approach. In this paper, I argue that philosophers ought to treat quality of life measures/proms as a distinct from these theories. I argue that quality of life/proms serve healthcare as vehicles for patient-centered care and this has important consequences for how we theorize these measures. To this end, two requirements set them apart from measures of subjective well-being and the capabilities approach: quality of life/proms need to be patient-directed and inclusive. (shrink)

This volume introduces readers to the main philosophical issues of measurement in medicine, illustrating the connections between the natural and social sciences by integrating essays on causation, measuring instruments and issues of measurement and policy.

Patient-reported outcome measures are now common endpoints in clinical trials. In 2009 in an effort to standardize and streamline their use in medical product labeling, the FDA published FDA Guidance for Industry Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims. This publication drew attention to the need to ensure that PROMs are methodologically sound. Nonetheless, in this paper I discuss how many of these measures continue to fall short in terms of validity, interpretability, and responsiveness. As (...) a reaction to these shortcomings, researchers increasingly call for the development of more scientific measures. I argue that although improving PROMs’ measurement properties is a worthy endeavor, we should not be uncritical of these attempts. Calling for improved measures in the name of science should not blind us to the way that even our best measures employ values in their development—values that may further the marketing needs of industry. When values are needed to further our scientific ends, it behooves us to examine them in terms of their social consequences. Thus I argue that we ought to consider not only the scientific advances that new PROMs may bring but also the values that are used to develop them. (shrink)

In the US and UK Births in obstetric units vastly outnumber births that take place outside of an obstetric unit. Still non-obstetric births are increasing in both countries. Is it professionally responsible to support a non-obstetric birth? It is morally responsible to choose to give birth at home? This debate has become heated with those on both sides finding empirical support for their positions. Indeed this moral debate is often carried out in terms of empirical evidence. While to some this (...) debate over the evidence is a distraction from what is genuinely at stake, namely different non-epistemic values, I will argue in this paper that the way forward is to take a closer and more fine grained look at the evidence. This closer look will first require that we distinguish between evidence of risk acceptability and evidence of safety and then focus carefully on evidence of the safety of non-obstetric births compared to obstetric births. (shrink)

In this paper I discuss how we should distinguish legitimate from illegitimate questions. I will argue that we should not make such distinctions prior to asking our questions; that questioning is more of an art than a science and that this art is part of the art of conversation in general. Nonetheless, the desire to limit in advance the questions that we can legitimately ask is not infrequent. In the philosophy of science this ambition manifests in response to concerns regarding (...) the corruption of scientific knowledge and inquiry. Similarly in the quantitative social sciences researchers develop measures by isolating in advance just those questions that they believe will best illuminate the construct under investigation. In order to preserve the integrity of their data much is done to avoid and adjust for errant respondent understandings of these questions. I argue, however, that limiting our questions in these ways does not secure knowledge and inquiry from bias, but rather unduly limits what we might come to know. Drawing on Gadamer’s work in Truth and Method I argue that we can distinguish legitimate from illegitimate questions, but that we can only do so by first asking them. (shrink)

This article tells the story of the oil and gas origins of the Gaia hypothesis, the theory that the Earth is a homeostatic system. It shows how Gaia’s key assumption—that the climate is a fundamentally stable system, able to withstand perturbations—emerged as a result of a collaboration between the theory’s progenitor, James Lovelock, and Royal Dutch Shell in response to Shell’s concerns about the effects of its products on the climate. The article explains how Lovelock elaborated the Gaia hypothesis and (...) gave it evidential depth through a series of Royal Dutch Shell-funded research projects meant to identify organisms whose biological activities might double as climate-regulating mechanisms. The article goes on to show how this research subsequently laid the foundation for a distinct genre of climate change denialism, in which corporations sowed doubt not by denying the phenomenon of global warming but by naturalizing it. (shrink)

Most public and non-profit organisations that fund health research provide the majority of their funding in the form of grants. The calls for grant applications are often untargeted, such that a wide variety of applications may compete for the same funding. The grant review process therefore plays a critical role in determining how limited research resources are allocated. Despite this, little attention has been paid to whether grant review criteria align with widely endorsed ethical criteria for allocating health research resources. (...) Here, we analyse the criteria and processes that ten of the largest public and non-profit research funders use to choose between competing grant applications. Our data suggest that research funders rarely instruct reviewers to consider disease burden or to prioritise research for sicker or more disadvantaged populations, and typically only include scientists in the review processes. This is liable to undermine efforts to link research funding to health needs. (shrink)

The vast majority of health research resources are used to study conditions that affect a small, advantaged portion of the global population. This distribution has been widely criticized as inequitable and threatens to exacerbate health disparities. However, there has been little systematic work on what individual health research funders ought to do in response. In this article, we analyze the general and special duties of research funders to the different populations that might benefit from health research. We assess how these (...) duties apply to governmental, multilateral, nonprofit, and for-profit organizations. We thereby derive a framework for how different types of funders should take the beneficiaries of research into account when they allocate scarce research resources. (shrink)

_K. al-Manām_ by Ibn Abī al-Dunyā is a compendium of 350 Muslim dream narratives in Arabic. The English introduction examines the function of dreams in classical Arabic literature with a focus on dreams as a means of edification.

Journal of Political Philosophy, EarlyView.

The need for greater privacy protections in the United States has never been greater. In their work, “Ethical Responsibilities for Companies That Process Personal Data”, McCoy et al. (2023) correct...

ABSTRACT Anthony Fauci, an infectious disease expert in the White House's coronavirus task force, is challenged to offer responsible public communication of science despite working under a habitual liar who has no tolerance for criticism or dissent. Fauci manages this rhetorical exigence by using strategic ambiguity, the topos of the honest broker, dissociation, and a narrative that constrains executive decision making.

The authors respond to a letter by Mitchell Berger in the March‐April 2024 issue of the Hastings Center Report concerning their essay “Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines.”.

In his recent article “Ethical Criteria for Health-Promoting Nudges: A Case-by-Case Analysis,” Bart Engelen (2019) develops a useful framework for evaluating health-related nudges in an attempt to...

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of ‘smart’ seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in ‘implantable smart technologies’, considering also whether regulation needs to respond to the autonomy that such artefacts carry (...) within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device’s ability to sense and transmit data and automate medicine can be associated with the ‘sting’ of autonomy being disassociated from human control as well as affecting individual, group, and social environments. (shrink)

Two of the most influential theories about scientific inference are inference to the best explanation and Bayesianism. How are they related? Bas van Fraassen has claimed that IBE and Bayesianism are incompatible rival theories, as any probabilistic version of IBE would violate Bayesian conditionalization. In response, several authors have defended the view that IBE is compatible with Bayesian updating. They claim that the explanatory considerations in IBE are taken into account by the Bayesian because the Bayesian either does or should (...) make use of them in assigning probabilities to hypotheses. I argue that van Fraassen has not succeeded in establishing that IBE and Bayesianism are incompatible, but that the existing compatibilist response is also not satisfactory. I suggest that a more promising approach to the problem is to investigate whether explanatory considerations are taken into account by a Bayesian who assigns priors and likelihoods on his or her own terms. In this case, IBE would emerge from the Bayesian account, rather than being used to constrain priors and likelihoods. I provide a detailed discussion of the case of how the Copernican and Ptolemaic theories explain retrograde motion, and suggest that one of the key explanatory considerations is the extent to which the explanation a theory provides depends on its core elements rather than on auxiliary hypotheses. I then suggest that this type of consideration is reflected in the Bayesian likelihood, given priors that a Bayesian might be inclined to adopt even without explicit guidance by IBE. The aim is to show that IBE and Bayesianism may be compatible, not because they can be amalgamated, but rather because they capture substantially similar epistemic considerations. 1 Introduction2 Preliminaries3 Inference to the Best Explanation4 Bayesianism5 The Incompatibilist View : Inference to the Best Explanation Contradicts Bayesianism5. 1 Criticism of the incompatibilist view6 Constraint - Based Compatibilism6. 1 Criticism of constraint - based compatibilism7 Emergent Compatibilism7. 1 Analysis of inference to the best explanation7. 1. 1 Inference to the best explanation on specific hypotheses7. 1. 2 Inference to the best explanation on general theories7. 1. 3 Copernicus versus Ptolemy7. 1. 4 Explanatory virtues7. 1. 5 Summary7. 2 Bayesian account8 Conclusion. (shrink)

BackgroundThe main purpose of this study was to describe the latent structure of pregnancy perception by investigating the role of risks and medical examinations in pregnancy perception across the sexes and pregnancy status.MethodsStudy 1 developed a questionnaire based on the responses of 29 young adults on their perception of pregnancy. Study 2 consisted of distributing the questionnaire among 290 participants.ResultsThe statistical clustering analysis revealed three major clusters of pregnancy perceptions: “evaluative,” “physio-medical,” and “future considerations,” each of them encompassing several meaningful (...) sub-clusters. This structure of pregnancy perceptions supports Beck and Beck-Gernsheim’s modernization approach. Negative emotions toward pregnancy were related to social cognitions, whereas thoughts about risks were included in the medical sub-cluster. After reliability analyses, comparisons of scale scores revealed that women experienced more positive emotions, thought more about physical symptoms and about future issues compared to men.ConclusionPregnant participants felt less ambivalence toward pregnancy, thought more about risks and medical examinations and less about parents’ duties than non-pregnant participants. (shrink)

The paradigm of rights, established throughout the academic, policy and migrant activism arenas, governs the protection of vulnerable migrant workers against abuse. To what extent this approach has achieved social justice for the migrant worker in the current global political economy climate is, however, uncertain. In analyzing the use of rights in migrant activism in Hong Kong, this paper shows the limitation of rights in the migrant experience at the same time as it shows how a new paradigm based on (...) the Capablities Approach could provide a more appropriate framework from which to achieve social justice for the migrant worker. (shrink)

There has been considerable puzzlement over how to respond to higher-order evidence. The existing dilemmas can be defused by adopting a ‘two-dimensional’ representation of doxastic attitudes which incorporates not only substantive uncertainty about which first-order state of affairs obtains but also the degree of conviction with which we hold the attitude. This makes it possible that in cases of higher-order evidence the evidence sometimes impacts primarily on our conviction, rather than our substantive uncertainty. I argue that such a two-dimensional representation (...) is naturally developed by making use of imprecise probabilities. (shrink)

Psychological studies show that the beliefs of two agents in a hypothesis can diverge even if both agents receive the same evidence. This phenomenon of belief polarisation is often explained by invoking biased assimilation of evidence, where the agents’ prior views about the hypothesis affect the way they process the evidence. We suggest, using a Bayesian model, that even if such influence is excluded, belief polarisation can still arise by another mechanism. This alternative mechanism involves differential weighting of the evidence (...) arising when agents have different initial views about the reliability of their sources of evidence. We provide a systematic exploration of the conditions for belief polarisation in Bayesian models which incorporate opinions about source reliability, and we discuss some implications of our findings for the psychological literature. (shrink)

BackgroundFunctional neurodiagnostics could allow researchers and clinicians to distinguish more accurately between the unresponsive wakefulness syndrome and the minimally conscious state. It remains unclear how it informs surrogate decision-making.ObjectiveTo explore how the next of kin of patients with disorders of consciousness interpret the results of a functional neurodiagnostics measure and how/why their interpretations influence their attitudes towards medical decisions.Methods and SampleWe conducted problem-centered interviews with seven next of kin of patients with DOC who had undergone a functional HD-EEG examination at (...) a neurological rehabilitation center in Germany. The examination included an auditory oddball paradigm and a motor imagery task to detect hidden awareness. We analyzed the interview transcripts using structuring qualitative content analysis.ResultsRegardless of the diagnostic results, all participants were optimistic of the patients’ meaningful recovery. We hypothesize, that participants deal with the results of examinations according to their belief system. Thus, an unfavorable evaluation of the patient’s state had the potential to destabilize the participant’s belief system. To re-stabilize or to prevent the destabilization of their belief system, participants used different strategies. Participants accepted a “positive” HD-EEG result since it stabilized their belief system.ConclusionWe hypothesize, that a group of next of kin of patients with DOC deals with functional neurodiagnostics results on the basis of the result’s value and their high hope that the patient will recover meaningfully. A psychological mechanism seems to moderate the impact of functional neurodiagnostics on surrogate treatment decisions. (shrink)

We respond to open peer commentaries on our target article, "Health Research Priority Setting: The Duties of Individual Funders".