The role of patients and their relatives in 'speaking up' about their own safety - a qualitative study of acute illness.

BACKGROUND: Poor recognition of and response to acute illness in hospitalized patients continues to cause significant harm despite the implementation of safety strategies such as early warning scores. Patients and their relatives may be able to contribute to their own safety by speaking up about changes in condition, but little is known about the factors that influence this. This study examined the experiences and views of patients and their relatives to determine the potential for involvement in promoting their own safety. METHODS: This data set is drawn from a wider ethnographic study of the management of the acutely ill patient in hospital. Thirteen patients and seven relatives from two medical settings in two UK NHS Trusts were interviewed. Thematic analysis identified factors likely to influence patients' and their relatives' ability to contribute to the management of deterioration. RESULTS: All patients interviewed had experienced their acute illness within the context of a long-term health problem. Speaking up was influenced by the ability to recognize changes in clinical condition, self-monitoring, confidence and trust, and culture and system of health care. When patients or relatives did raise concerns, health-care staff had a mediating effect on their comfort with and the effectiveness of speaking up. IMPLICATIONS: Safety strategies based on patient involvement must take account of the complexities of acute illness. Those that promote partnership may be more acceptable to patients, their families and staff than those that promote challenging behaviour and may ultimately prove to be most safe and effective.

Expect the unexpected: patients' and families' expectations and experiences of new clinical procedures.

BACKGROUND: Early stage clinical innovation often occurs 'under the radar' of governance systems for established procedures. Previously impossible or unavailable techniques still being developed involve additional uncertainty and unknown risks and benefits compared with standard procedures. Patient and family expectations, perceptions and experiences of these new procedures and their possible impacts on aspects of patient safety are under-researched. OBJECTIVE: To explore patient and family expectations and experiences of undergoing new clinical procedures. SETTING: A large UK Hospital NHS Foundation Trust with a range of clinically innovative specialties. METHODS: We interviewed 15 patients who received new clinical procedures in a variety of medical and surgical specialties. Qualitative interviews were used to facilitate in-depth exploration of patient and family views and experiences. Topics included patient and family access to and expectations of the procedure, informed decision making regarding acceptance of new procedures and post-procedure experiences. RESULTS: Some patients sought out specific interventions, while others accepted new treatment options that clinicians proposed. Most participants reported that explanations about the procedure and risks were clear, and there were opportunities to ask questions prior to the procedure. Most participants also regarded their procedures as successful. However, post-procedure information follow-up was often reported as lacking and some outcomes were considerably problematic and raised patient safety issues. DISCUSSION: The importance of patients' and family views in evaluating health care are increasingly recognized. We discuss the implications of our findings for informed decision making and post-intervention follow-up.

Reflections on the implementation of governance structures for early-stage clinical innovation.

OBJECTIVES: This paper seeks to further explore the question of how best to monitor and govern innovative clinical procedures in their earliest phase of development. We examine the potential value of proposed governance frameworks, such as the IDEAL model, and examine the functioning of a novel procedures review committee. METHODS: The paper draws upon 20 qualitative, semi-structured interviews. Nine interviews were conducted with members of a committee that was established as a means of governing innovative procedures within a large National Health Service Foundation Trust hospital in the UK. Eleven interviews were conducted with health providers involved with the development of a variety of novel clinical procedures. RESULTS: Prominent themes from the data include the potential willingness of clinicians to engage with regulatory frameworks for innovative procedures, existing ways in which clinicians and others attempt to ensure patient's safety and manage uncertainty in the context of novel procedures, views on the potential benefits and drawbacks of engaging with a review committee for novel procedures, and the pragmatic considerations and potential unintended consequences that are entailed in the implementation of regulatory requirements for the monitoring of innovative procedures. CONCLUSIONS: The views of committee members and clinical innovators help us to understand the practical issues of implementing governance structures for novel clinical procedures. The data illustrate those factors that must be taken into account if governance is to support innovation rather than act as an inhibiting factor in the development of new clinical procedures.

Donation of 'spare' fresh or frozen embryos to research: who decides that an embryo is 'spare' and how can we enhance the quality and protect the validity of consent?

This paper analyses elements of the legal process of consent to the donation of 'spare' embryos to research, including stem-cell research, and makes a recommendation intended to enhance the quality of that process, including on occasion by guarding against the invalidity of such consent. This is important in its own right and also so as to maximise the reproductive treatment options of couples engaged in in vitro fertilisation (IVF) treatment and to avoid possible harms to them. In Part 1, with reference to qualitative data from three UK IVF clinics, we explore the often delicate and contingent nature of what comes to be, for legal purposes, a 'spare' embryo. The way in which an embryo becomes 'spare', with its implications for the process of consent to donation to research, is not addressed in the relevant reports relating to or codes of practice governing the donation of embryos to research, which assume an unproblematic notion of the 'spare' embryo. Significantly, our analysis demonstrates that there is an important and previously unrecognised first stage in the donation of a 'spare' embryo to research, namely: consent to an embryo being 'spare' and so, at the same time, to its disuse in treatment. This is not explicitly covered by the Human Fertilisation and Embryology (HFE) Act 1990, as amended by the HFE Act 2008. Having identified this important initial stage in the process of consent to the donation of a 'spare' embryo to research in conclusion to Part 1, in Part 2 we analyse the idea of consent to an embryo's disuse in treatment on the basis that it is 'spare' with reference to the legal elements of consent, namely information as to nature and purpose, capacity, and voluntariness. We argue that there are in fact three related consent processes in play, of which the principal one concerns consent to an embryo's disuse in treatment. If the quality of this first consent is compromised, in turn this will impact on the quality of the consent to the donation of that 'spare' embryo to research, followed by the quality of consent to future cycles of assisted reproduction treatment in the event that these are needed as a result of a donation decision. The analysis overall is of central relevance to the debate as to whether, and if so when, it should be permissible to request the donation of fresh embryos for research, as opposed to those that have been frozen and, for instance, have reached the end of their statutory storage term. This has a particular bearing on the donation of embryos to stem-cell research since there is a debate as to whether fresh embryos are most useful for this.

Embryo futures and stem cell research: the management of informed uncertainty.

In the social worlds of assisted conception and stem cell science, uncertainties proliferate and particular framings of the future may be highly strategic. In this article we explore meanings and articulations of the future using data from our study of ethical and social issues implicated by the donation of embryos to human embryonic stem cell research in three linked assisted conception units and stem cell laboratories in the UK. Framings of the future in this field inform the professional management of uncertainty and we explore some of the tensions this involves in practice. The bifurcation of choices for donating embryos into accepting informed uncertainty or not donating at all was identified through the research process of interviews and ethics discussion groups. Professional staff accounts in this study contained moral orientations that valued ideas such as engendering patient trust by offering full information, the sense of collective ownership of the National Heath Service and publicly funded science and ideas for how donors might be able to give restricted consent as a third option.

Constructing an ethical framework for embryo donation to research: is it time for a restricted consent policy?

An Ethics & Policy Workshop was held with 20 invited UK stakeholders to consider whether embryo donors should be able to restrict the future use of human embryonic stem cells (hESCs) created from their embryos. Participants cited tensions between pure altruism and a more reciprocal basis for donation; and between basic research (in which genetic material would never form part of another living being) and treatment applications. Two restriction models were suggested to acknowledge specific ethical issues raised by hESCs' use in research and treatments: (1) a two tier system: hESCs with unrestricted consent could go to the UK Stem Cell Bank; those with restricted consent could be used in individual labs which could guarantee to honour the restrictions, and Bank deposit would not be required. (2) a three category system: restrictions could include (i) basic hESC research; (ii) hESC research and treatment; no gamete derivation (iii) 'unrestricted' hESC research and treatment.

Fresh or frozen? Classifying 'spare' embryos for donation to human embryonic stem cell research.

United Kingdom (UK) funding to build human embryonic stem cell (hESC) derivation labs within assisted conception units (ACU) was intended to facilitate the 'In-vitro fertilisation (IVF)-stem cell interface', including the flow of fresh 'spare' embryos to stem cell labs. However, in the three sites reported on here, which received this funding, most of the embryos used for hESC research came from long term cryopreservation storage and/or outside clinics. In this paper we explore some of the clinical, technical, social and ethical factors that might help to explain this situation. We report from our qualitative study of the ethical frameworks for approaching women/couples for donation of embryos to stem cell research. Members of staff took part in 44 interviews and six ethics discussion groups held at our study sites between February 2008 and October 2009. We focus here on their articulations of social and ethical, as well as scientific, dimensions in the contingent classification of 'spare' embryos, entailing uncertainty, fluidity and naturalisation in classifying work. Social and ethical factors include acknowledging and responding to uncertainty in classifying embryos; retaining 'fluidity' in the grading system to give embryos 'every chance'; tensions between standardisation and variation in enacting a 'fair' grading system; enhancement of patient choice and control, and prevention of regret; and incorporation of patients' values in construction of ethically acceptable embryo 'spareness' ('frozen' embryos, and embryos determined through preimplantation genetic diagnosis (PGD) to be genetically 'affected'). We argue that the success of the 'built moral environment' of ACU with adjoining stem cell laboratories building projects intended to facilitate the 'IVF-stem cell interface' may depend not only on architecture, but also on the part such social and ethical factors play in configuration of embryos as particular kinds of moral work objects.

A 'healthy baby': The double imperative of preimplantation genetic diagnosis.

This article reports from a study exploring the social processes, meanings and institutions that frame and produce 'ethical problems' and clinical dilemmas for practitioners, scientists and others working in the specialty of preimplantation genetic diagnosis (PGD). A major topic in the data was that, in contrast to IVF, the aim of PGD is to transfer to the woman's womb only those embryos likely to be unaffected by serious genetic disorders; that is, to produce 'healthy babies'. Staff described the complex processes through which embryos in each treatment cycle must meet a double imperative: they must be judged viable by embryologists and 'unaffected' by geneticists. In this article, we focus on some of the ethical, social and occupational issues for staff ensuing from PGD's double imperative.

Consenting futures: professional views on social, clinical and ethical aspects of information feedback to embryo donors in human embryonic stem cell research.

This paper reports from an ongoing multidisciplinary, ethnographic study that is exploring the views, values and practices (the ethical frameworks) drawn on by professional staff in assisted conception units and stem cell laboratories in relation to embryo donation for research purposes, particularly human embryonic stem cell (hESC) research, in the UK. We focus here on the connection between possible incidental findings and the circumstances in which embryos are donated for hESC research, and report some of the uncertainties and dilemmas of our staff participants. We explore the views of our study participants in relation to two themes: (1) rights to information and anticipating how donors might be informed about future research findings and (2) occupational work goals and trust.

The embryo as moral work object: PGD/IVF staff views and experiences.

We report on one aspect of a study that explored the views and experiences of practitioners and scientists on social, ethical and clinical dilemmas encountered when working in the field of preimplantation genetic diagnosis (PGD) for serious genetic disorders. The study produced an ethnography based on observation, interviews and ethics discussion groups with staff from two PGD/IVF Units in the UK. We focus here on staff perceptions of work with embryos that entails disposing of 'affected' or 'spare' embryos or using them for research. A variety of views were expressed on the 'embryo question' in contrast to polarised media debates. We argue that the prevailing policy acceptance of destroying affected embryos, and allowing research on embryos up to 14 days leaves some staff with rarely reported, ambivalent feelings. Staff views are under-researched in this area and we focus on how they may reconcile their personal moral views with the ethical framework in their field. Staff construct embryos in a variety of ways as 'moral work objects'. This allows them to shift attention between micro-level and overarching institutional work goals, building on Casper's concept of 'work objects' and focusing on negotiation of the social order in a morally contested field.

Choosing embryos: ethical complexity and relational autonomy in staff accounts of PGD.

The technique of preimplantation genetic diagnosis (PGD) is commonly explained as a way of checking the genes of embryos produced by IVF for serious genetic diseases. However, complex accounts of this technique emerged during ethics discussion groups held for PGD staff. These form part of a study exploring the social processes, meanings and institutions that frame and produce 'ethical problems' for practitioners, scientists and others working in the specialty of PGD in the UK. Two 'grey areas' raised by staff are discussed in terms of how far staff are, or in the future may be, able to support autonomous choices of women/couples: accepting 'carrier' embryos within the goal of creating a 'healthy' child; and sex selection of embryos for social reasons. These grey areas challenged the staff's resolve to offer individual informed choice, in the face of their awareness of possible collective social effects that might ensue from individual choices. We therefore argue that these new forms of choice pose a challenge to conventional models of individual autonomy used in UK genetic and reproductive counselling, and that 'relational autonomy' may be a more suitable ethical model to describe the ethical principles being drawn on by staff working in this area.

Facilitating choice, framing choice: staff views on widening the scope of preimplantation genetic diagnosis in the UK.

In the UK, the Human Fertilisation and Embryology Authority (HFEA) is responsible for licensing preimplantation genetic diagnosis (PGD). To date, licenses have been issued for the testing of about 70 genetic conditions, drawing on three key 'ethical principles'. Following a public consultation, the HFEA has recently widened the scope for PGD to include susceptibility to late onset, lower penetrance conditions such as inherited breast cancer. As the numbers and types of conditions which can potentially be tested for rises, the question of how, and indeed what limits should be set is timely. Drawing on qualitative interviews and ethics discussion groups which took place prior to or during the HFEA consultation, this paper explores the views of staff working in or linked to one PGD Unit in the UK, as to how they saw these potential changes. The paper thus provides an opportunity to develop greater understanding of how staff working in a morally contentious, innovative area viewed the potential expansion of their work, prior to that expansion taking place. Key themes include 'drawing lines' on behalf of others, particularly with the current emphasis on individual reproductive autonomy; and balancing the invasiveness and possible risks of PGD treatment against the 'seriousness' of the condition. More broadly, the paper highlights the complexities involved in trying to develop general 'ethical principles' to govern the use of ever evolving reproductive technologies.

Telling cultures: 'cultural' issues for staff reporting concerns about colleagues in the UK National Health Service.

Recent UK health policy initiatives promote a 'no blame culture' and learning from adverse events to enhance patient safety in the NHS. Similar initiatives exist in the USA and Australia. Changing the 'blame culture' in the NHS has been advocated in policy documents and inquiry reports for over a decade. Some key concepts that are used in the policy discourse -'blame'; mistakes, errors and misdemeanours; and 'culture'- are examined and considered in the light of pertinent social science literature to question some of the assumptions concerning these terms in the policy discourse, and to suggest some alternative questions and perspectives. The Three Inquiries, a recent series of statutory inquiries held in the UK, are used as a case study to explore some of the intra- and inter-professional difficulties of reporting errors and misconduct by medical practitioners. The paper offers an interpretive social science perspective as an alternative to more policy oriented and managerial approaches to patient safety issues, focusing on deeper structural aspects of organisational phenomena implicated in the ability or otherwise of medical and other healthcare staff to report mistakes and misconduct as one aspect of patient safety.

Social welfare, genetic welfare? Boundary-work in the IVF/PGD clinic.

Through the lens of the 'welfare of the child' assessment, this paper explores how staff working in the area of in vitro fertilisation and preimplantation genetic diagnosis (IVF/PGD) balance reflexive relations of legitimacy and accountability between the public and private spheres, and between medicine, the citizen and the state. The wider research of which this analysis is a part uses multiple methods to study two National Health Service Assisted Conception Units in England. Research methods used included observation clinics and interviews with staff from a range of disciplines. We illustrate how the staff reveal tensions between their views that the welfare of the child assessment can be seen as intrusive and discriminatory, and on the other hand that medical intervention in reproduction should be socially and professionally accountable. These tensions can be understood sociologically in terms of a gradual movement from socially based solutions to fertility problems and disabilities, towards a biomedical, and arguably genetically oriented worldview of such problems. Rather than being viewed as discrete, these two orientations should be seen as indicating an emergent direction of travel along a continuum, with elements of both being present in the accounts. We argue that consideration of the welfare of the child involves staff in ethical boundary-work across the two orientations and between the accountabilities and responsibilities of healthcare professionals, individuals and the state.

Human resources policies and continuity of care.

Explores the implications for continuity of care of the wide range of policy initiatives currently affecting the management and use of human resources in the UK National Health Service. Draws on the findings of a short study undertaken in 2001 comprising a policy document analysis and a series of expert seminars discussing the impact of the policies in practice. A variety of potential long-term gains for continuity of care were identifiable in the current raft of policy initiatives and seminar participants agreed that, when these policies are fully implemented, continuity of care should be enhanced in several ways. However, the impact to date has been rather more equivocal because of the damaging effects of the process of policy implementation on continuity within the system and on staff attitudes and values. If continuity of care is accepted as an important element of quality in health care, more attention must be given to developing strategies which support system continuity.