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)