Risk, Overdiagnosis and Ethical Justifications.

Many healthcare practices expose people to risks of harmful outcomes. However, the major theories of moral philosophy struggle to assess whether, when and why it is ethically justifiable to expose individuals to risks, as opposed to actually harming them. Sven Ove Hansson has proposed an approach to the ethical assessment of risk imposition that encourages attention to factors including questions of justice in the distribution of advantage and risk, people's acceptance or otherwise of risks, and the scope individuals have to influence the practices that generate risk. This paper investigates the ethical justifiability of preventive healthcare practices that expose people to risks including overdiagnosis. We applied Hansson's framework to three such practices: an 'ideal' breast screening service, a commercial personal genome testing service, and a guideline that lowers the diagnostic threshold for hypertension. The framework was challenging to apply, not least because healthcare has unclear boundaries and involves highly complex practices. Nonetheless, the framework encouraged attention to issues that would be widely recognised as morally pertinent. Our assessment supports the view that at least some preventive healthcare practices that impose risks including that of overdiagnosis are not ethically justifiable. Further work is however needed to develop and/or test refined assessment criteria and guidance for applying them.

Why Health and Social Care Support for People with Long-Term Conditions Should be Oriented Towards Enabling Them to Live Well.

There are various reasons why efforts to promote "support for self-management" have rarely delivered the kinds of sustainable improvements in healthcare experiences, health and wellbeing that policy leaders internationally have hoped for. This paper explains how the basis of failure is in some respects built into the ideas that underpin many of these efforts. When (the promotion of) support for self-management is narrowly oriented towards educating and motivating patients to adopt the behaviours recommended for disease control, it implicitly reflects and perpetuates limited and somewhat instrumental views of patients. It tends to: restrict the pursuit of respectful and enabling 'partnership working'; run the risk of undermining patients' self-evaluative attitudes (and then of failing to notice that as harmful); limit recognition of the supportive value of clinician-patient relationships; and obscure the practical and ethical tensions that clinicians face in the delivery of support for self-management. We suggest that a focus on enabling people to live (and die) well with their long-term conditions is a promising starting point for a more adequate conception of support for self-management. We then outline the theoretical advantages that a capabilities approach to thinking about living well can bring to the development of an account of support for self-management, explaining, for example, how it can accommodate the range of what matters to people (both generally and more specifically) for living well, help keep the importance of disease control in perspective, recognize social influences on people's values, behaviours and wellbeing, and illuminate more of the rich potential and practical and ethical challenges of supporting self-management in practice.

We need to talk about purpose: a critical interpretive synthesis of health and social care professionals' approaches to self-management support for people with long-term conditions.

BACKGROUND: Health policies internationally advocate 'support for self-management', but it is not clear how the promise of the concept can be fulfilled. OBJECTIVE: To synthesize research into professional practitioners' perspectives, practices and experiences to help inform a reconceptualization of support for self-management. DESIGN: Critical interpretive synthesis using systematic searches of literature published 2000-2014. FINDINGS: We summarized key insights from 164 relevant papers in an annotated bibliography. The literature illustrates striking variations in approaches to support for self-management and interpretations of associated concepts. We focused particularly on the somewhat neglected question of the purpose of support. We suggest that this can illuminate and explain important differences between narrower and broader approaches. Narrower approaches support people to manage their condition(s) well in terms of disease control. This purpose can underpin more hierarchical practitioner-patient communication and more limited views of patient empowerment. It is often associated with experiences of failure and frustration. Broader approaches support people to manage well with their condition(s). They can keep work on disease control in perspective as attention focuses on what matters to people and how they can be supported to shape their own lives. Broader approaches are currently less evident in practice. DISCUSSION AND CONCLUSION: Broader approaches seem necessary to fulfil the promise of support for self-management, especially for patient empowerment. A commitment to enable people to live well with long-term conditions could provide a coherent basis for the forms and outcomes of support that policies aspire to. The implications of such a commitment need further attention.

Ethical issues raised by thyroid cancer overdiagnosis: A matter for public health?

Current practices of identifying and treating small indolent thyroid cancers constitute an important but in some ways unusual form of overdiagnosis. Overdiagnosis refers to diagnoses that generally harm rather than benefit patients, primarily because the diagnosed condition is not a harmful form of disease. Patients who are overdiagnosed with thyroid cancer are harmed by the psycho-social impact of a cancer diagnosis, as well as treatment interventions such partial or total thyroidectomy, lifelong thyroid replacement hormone, monitoring, surgical complications and other side effects. These harms seem to outweigh any putative benefit of knowing about a cancer that would not have caused problems if left undiscovered. In addition to harms to patients, thyroid cancer overdiagnosis leads to significant opportunity costs at a societal level, due to costs of diagnosis and treatment. Unlike many other overdiagnosed cancers, accurate risk stratification is possible with thyroid cancer. At the individual patient level, use of this risk information might support informed choice and/or shared decision-making, as mandated by clinical ethics frameworks. And this approach might, to some extent, help to reduce rates of diagnosis and intervention. In practice, however, it is unlikely to stem the rising incidence and associated harms and costs of overdiagnosed thyroid cancer, especially in situations where health professionals have conflicts of interest. We argue in this article that thyroid cancer overdiagnosis may be usefully understood as a public health problem, and that some public health approaches will be readily justifiable and are more likely to be effective in minimising its harms.

"Was that a success or not a success?": a qualitative study of health professionals' perspectives on support for people with long-term conditions.

BACKGROUND: Support for self-management (SSM) is a prominent strand of health policy internationally, particularly for primary care. It is often discussed and evaluated in terms of patients' knowledge, skills and confidence, health-related behaviours, disease control or risk reduction, and service use and costs. However, these goals are limited, both as guides to professional practice and as indicators of its quality. In order to better understand what it means to support self-management well, we examined health professionals' views of success in their work with people with long-term conditions. This study formed part of a broader project to develop a conceptual account of SSM that can reflect and promote good practice. METHODS: Semi-structured individual interviews (n = 26) and subsequent group discussions (n = 5 groups, 30 participants) with diverse health professionals working with people with diabetes and/or Parkinson's disease in NHS services in London, northern England or Scotland. The interviews explored examples of more and less successful work, ways of defining success, and ideas about what facilitates success in practice. Subsequent group discussions considered the practical implications of different accounts of SSM. Interviews and group discussions were audio-recorded, transcribed and analysed thematically. RESULTS: Participants identified a wide range of interlinked aspects or elements of success relating to: health, wellbeing and quality of life; how well people (can) manage; and professional-patient relationships. They also mentioned a number of considerations that have important implications for assessing the quality of their own performance. These considerations in part reflect variations in what matters and what is realistically achievable for particular people, in particular situations and at particular times, as well as the complexity of questions of attribution. CONCLUSIONS: A nuanced assessment of the quality of support for self-management requires attention to the responsiveness of professional practice to a wide, complex range of personal and situational states, as well as actions and interactions over time. A narrow focus on particular indicators can lead to insensitive or even perverse judgements and perhaps counterproductive effects. More open, critical discussions about both success and the assessment of quality are needed to facilitate good professional practice and service improvement initiatives.

Addressing Deficits and Injustices: The Potential Epistemic Contributions of Patients to Research.

Patient or public involvement (PPI) in health research is increasingly expected as a matter of policy. In theory, PPI can contribute both to the epistemic aims intrinsic to research (generating knowledge), and to extrinsically valued features of research such as social inclusion and transparency. In practice, the aims of PPI have not always been clear, although there has been a tendency to encourage the involvement of so-called ordinary people who are regarded as representative of an assumed patient perspective. In this paper we focus on the epistemic potential of PPI, using theoretical work in epistemology to develop a nuanced account of patients' experiential knowledge and how this might contribute directly to conceptual development, hypothesis generation and data interpretation. We also consider how some features of health research pose barriers to this kind of epistemic contribution. Drawing on Miranda Fricker's idea of testimonial injustice, we explore how disciplinary indicators of credibility in clinical and academic health research contexts might be wrongly applied to those involved in PPI, undermining their potential to contribute. Finally we argue for a range of strategies to maximize opportunities for patients to engage with research teams and make epistemologically significant contributions to research.

Personalised care planning for adults with chronic or long-term health conditions.

BACKGROUND: Personalised care planning is a collaborative process used in chronic condition management in which patients and clinicians identify and discuss problems caused by or related to the patient's condition, and develop a plan for tackling these. In essence it is a conversation, or series of conversations, in which they jointly agree goals and actions for managing the patient's condition. OBJECTIVES: To assess the effects of personalised care planning for adults with long-term health conditions compared to usual care (i.e. forms of care in which active involvement of patients in treatment and management decisions is not explicitly attempted or achieved). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, ProQuest, clinicaltrials.gov and WHO International Clinical Trials Registry Platform to July 2013. SELECTION CRITERIA: We included randomised controlled trials and cluster-randomised trials involving adults with long-term conditions where the intervention included collaborative (between individual patients and clinicians) goal setting and action planning. We excluded studies where there was little or no opportunity for the patient to have meaningful influence on goal selection, choice of treatment or support package, or both. DATA COLLECTION AND ANALYSIS: Two of three review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes were effects on physical health, psychological health, subjective health status, and capabilities for self management. Secondary outcomes included effects on health-related behaviours, resource use and costs, and type of intervention. A patient advisory group of people with experience of living with long-term conditions advised on various aspects of the review, including the protocol, selection of outcome measures and emerging findings. MAIN RESULTS: We included 19 studies involving a total of 10,856 participants. Twelve of these studies focused on diabetes, three on mental health, one on heart failure, one on end-stage renal disease, one on asthma, and one on various chronic conditions. All 19 studies included components that were intended to support behaviour change among patients, involving either face-to-face or telephone support. All but three of the personalised care planning interventions took place in primary care or community settings; the remaining three were located in hospital clinics. There was some concern about risk of bias for each of the included studies in respect of one or more criteria, usually due to inadequate or unclear descriptions of research methods. Physical healthNine studies measured glycated haemoglobin (HbA1c), giving a combined mean difference (MD) between intervention and control of -0.24% (95% confidence interval (CI) -0.35 to -0.14), a small positive effect in favour of personalised care planning compared to usual care (moderate quality evidence).Six studies measured systolic blood pressure, a combined mean difference of -2.64 mm/Hg (95% CI -4.47 to -0.82) favouring personalised care (moderate quality evidence). The pooled results from four studies showed no significant effect on diastolic blood pressure, MD -0.71 mm/Hg (95% CI -2.26 to 0.84).We found no evidence of an effect on cholesterol (LDL-C), standardised mean difference (SMD) 0.01 (95% CI -0.09 to 0.11) (five studies) or body mass index, MD -0.11 (95% CI -0.35 to 0.13) (four studies).A single study of people with asthma reported that personalised care planning led to improvements in lung function and asthma control. Psychological healthSix studies measured depression. We were able to pool results from five of these, giving an SMD of -0.36 (95% CI -0.52 to -0.20), a small effect in favour of personalised care (moderate quality evidence). The remaining study found greater improvement in the control group than the intervention group.Four other studies used a variety of psychological measures that were conceptually different so could not be pooled. Of these, three found greater improvement for the personalised care group than the usual care group and one was too small to detect differences in outcomes. Subjective health statusTen studies used various patient-reported measures of health status (or health-related quality of life), including both generic health status measures and condition-specific ones. We were able to pool data from three studies that used the SF-36 or SF-12, but found no effect on the physical component summary score SMD 0.16 (95% CI -0.05 to 0.38) or the mental component summary score SMD 0.07 (95% CI -0.15 to 0.28) (moderate quality evidence). Of the three other studies that measured generic health status, two found improvements related to personalised care and one did not.Four studies measured condition-specific health status. The combined results showed no difference between the intervention and control groups, SMD -0.01 (95% CI -0.11 to 0.10) (moderate quality evidence). Self-management capabilitiesNine studies looked at the effect of personalised care on self-management capabilities using a variety of outcome measures, but they focused primarily on self efficacy. We were able to pool results from five studies that measured self efficacy, giving a small positive result in favour of personalised care planning: SMD 0.25 (95% CI 0.07 to 0.43) (moderate quality evidence).A further five studies measured other attributes that contribute to self-management capabilities. The results from these were mixed: two studies found evidence of an effect on patient activation, one found an effect on empowerment, and one found improvements in perceived interpersonal support. Other outcomesPooled data from five studies on exercise levels showed no effect due to personalised care planning, but there was a positive effect on people's self-reported ability to carry out self-care activities: SMD 0.35 (95% CI 0.17 to 0.52).We found no evidence of adverse effects due to personalised care planning.The effects of personalised care planning were greater when more stages of the care planning cycle were completed, when contacts between patients and health professionals were more frequent, and when the patient's usual clinician was involved in the process. AUTHORS' CONCLUSIONS: Personalised care planning leads to improvements in certain indicators of physical and psychological health status, and people's capability to self-manage their condition when compared to usual care. The effects are not large, but they appear greater when the intervention is more comprehensive, more intensive, and better integrated into routine care.

Use of a birth plan within woman-held maternity records: a qualitative study with women and staff in northeast Scotland.

BACKGROUND: Birth plans are written preferences for labor and birth which women prepare in advance. Most studies have examined them as a novel intervention or "outside" formal care provision. This study considered use of a standard birth plan section within a national, woman-held maternity record. METHODS: Exploratory qualitative interviews were conducted with women (42) and maternity service staff (24) in northeast Scotland. Data were analyzed thematically. RESULTS: Staff and women were generally positive about the provision of the birth plan section within the record. Perceived benefits included the opportunity to highlight preferences, enhance communication, stimulate discussions, and address anxieties. However, not all women experienced these benefits or understood the birth plan's purpose. Some were unaware of the opportunity to complete it or could not access the support they needed from staff to discuss or be confident about their options. Some were reluctant to plan too much. Staff recognized the need to support women with birth plan completion but noted practical challenges to this. CONCLUSIONS: A supportive antenatal opportunity to allow discussion of options may be needed to realize the potential benefits of routine inclusion of birth plans in maternity notes.

Tackling disrespect in health care: The relevance of socio-relational equality.

Disrespect in health care often persists despite firm commitments to respectful service provision. This conceptual paper highlights how the ways in which respect and disrespect are characterised can have practical implications for how well disrespect can be tackled. We stress the need to focus explicitly on disrespect (not only respect) and propose that disrespect can usefully be understood as a failure to relate to people as equals. This characterisation is consonant with some accounts of respect but sometimes obscured by a focus on respecting people's autonomy and dignity. Emphasising equality is consistent with connections patients draw between being (dis)respected and (in)equality. It readily accommodates microaggressions as forms of disrespect, helping to understand how and why experiences of disrespect may be unintentional and to explain why even small instances of disrespect are wrong. Our view of disrespect with an emphasis on equality strengthens the demand that health systems take disrespect seriously as a problem of social injustice and tackle it at institutional, not just individual levels. It suggests several strategies for practical action. Emphasising relational equality is not an easy or short-term fix for disrespect, but it signals a direction of travel towards an important improvement ambition.

Telephone consulting for 'Personalised Care and Support Planning' with people with long-term conditions: a qualitative study of healthcare professionals' experiences during COVID-19 restrictions and beyond.

BACKGROUND: Personalised Care and Support Planning (PCSP) replaces conventional annual reviews for people with long-term conditions. It is designed to help healthcare professionals (HCPs) and patients engage in conversations as equals and collaboratively plan actions oriented to each patient's priorities, alongside biomedical concerns. Little is known about how the shift to remote consulting initiated with COVID-19 restrictions has impacted PCSP. AIM: To investigate HCPs' experiences of conducting PCSP conversations remotely and consider implications for the fulfilment of PCSP ambitions as remote consulting continues beyond COVID-19 restrictions. METHODS: 19 semi-structured interviews with HCPs in England and Scotland; interpretive analysis. RESULTS: HCPs' accounts made clear that COVID-19 restrictions impacted multiple aspects of PCSP delivery, not just the mode of conversation. Broader disruption to general practice systems for gathering and sharing information ahead of PCSP conversations, and moves to 'wide window' appointment times, made it harder for patients to be prepared for PCSP conversations. This constrained scope to achieve PCSP ambitions even with the best professional communication skills. Most remote PCSP conversations were conducted by telephone. In the absence of visual communication with patients, it was sometimes harder to achieve the ambitions of PCSP conversations, including to balance patient and professional agendas, fulfil key planning activities, and foster a relational ethos of equal, collaborative partnership. The challenges were particularly severe when working with new patients and people with complex clinical and social problems. Although options for telephone appointments now offer valued flexibility, sustained experience of struggling to achieve PCSP ambitions via remote consulting led some HCPs to lower their standards for judging a "good" PCSP conversation, and to diminished professional satisfaction. CONCLUSIONS: There are significant challenges to fulfilling the ambitions of PCSP via telephone, especially when preparatory support is limited. This study provides grounds for scepticism about how compatible telephone appointments can be with this person-centred model of working, especially for people who are socially disadvantaged and live with complex health conditions. These threats to the provision of person-centred support for people with long-term conditions warrant careful attention going forward if the PCSP model and its benefits are to be sustained.

Treating patients as persons: a capabilities approach to support delivery of person-centered care.

Health services internationally struggle to ensure health care is "person-centered" (or similar). In part, this is because there are many interpretations of "person-centered care" (and near synonyms), some of which seem unrealistic for some patients or situations and obscure the intrinsic value of patients' experiences of health care delivery. The general concern behind calls for person-centered care is an ethical one: Patients should be "treated as persons." We made novel use of insights from the capabilities approach to characterize person-centered care as care that recognizes and cultivates the capabilities associated with the concept of persons. This characterization unifies key features from previous characterisations and can render person-centered care applicable to diverse patients and situations. By tying person-centered care to intrinsically valuable capability outcomes, it incorporates a requirement for responsiveness to individuals and explains why person-centered care is required independently of any contribution it may make to health gain.

How the stigma of low literacy can impair patient-professional spoken interactions and affect health: insights from a qualitative investigation.

BACKGROUND: Low literacy is a significant problem across the developed world. A considerable body of research has reported associations between low literacy and less appropriate access to healthcare services, lower likelihood of self-managing health conditions well, and poorer health outcomes. There is a need to explore the previously neglected perspectives of people with low literacy to help explain how low literacy can lead to poor health, and to consider how to improve the ability of health services to meet their needs. METHODS: Two stage qualitative study. In-depth individual interviews followed by focus groups to confirm analysis and develop suggestions for service improvements. A purposive sample of 29 adults with English as their first language who had sought help with literacy was recruited from an Adult Learning Centre in the UK. RESULTS: Over and above the well-documented difficulties that people with low literacy can have with the written information and complex explanations and instructions they encounter as they use health services, the stigma of low literacy had significant negative implications for participants' spoken interactions with healthcare professionals.Participants described various difficulties in consultations, some of which had impacted negatively on their broader healthcare experiences and abilities to self-manage health conditions. Some communication difficulties were apparently perpetuated or exacerbated because participants limited their conversational engagement and used a variety of strategies to cover up their low literacy that could send misleading signals to health professionals. Participants' biographical narratives revealed that the ways in which they managed their low literacy in healthcare settings, as in other social contexts, stemmed from highly negative experiences with literacy-related stigma, usually from their schooldays onwards. They also suggest that literacy-related stigma can significantly undermine mental wellbeing by prompting self-exclusion from social participation and generating a persistent anxiety about revealing literacy difficulties. CONCLUSION: Low-literacy-related stigma can seriously impair people's spoken interactions with health professionals and their potential to benefit from health services. As policies increasingly emphasise the need for patients' participation, services need to simplify the literacy requirements of service use and health professionals need to offer non-judgemental (universal) literacy-sensitive support to promote positive healthcare experiences and outcomes.

Implementing and evaluating care and support planning: a qualitative study of health professionals' experiences in public polyclinics in Singapore.

BACKGROUND: Two polyclinics in Singapore modified systems and trained health professionals to provide person-centred Care and Support Planning (CSP) for people with diabetes within a clinical trial. We aimed to investigate health professionals' perspectives on CSP to inform future developments. METHODS: Qualitative research including 23 semi-structured interviews with 13 health professionals and 3 co-ordinators. Interpretive analysis, including considerations of how different understandings, enactments, experiences and evaluative judgements of CSP clustered across health professionals, and potential causal links between them. RESULTS: Both polyclinic teams introduced CSP and sustained it through COVID-19 disruptions. The first examples health professionals gave of CSP 'going well' all involved patients who came prepared, motivated and able to modify behaviours to improve their biomedical markers, but health professionals also said that they only occasionally saw such patients in practice. Health professionals' accounts of how they conducted CSP conversations varied: some interpretations and reported enactments were less clearly aligned with the developers' person-centred aspirations than others. Health professionals brought different communication skill repertoires to their encounters and responded variably to challenges to CSP that arose from: the linguistic and educational diversity of patients in this polyclinic context; the cultural shift that CSP involved; workload pressures; organisational factors that limited relational and informational continuity of care; and policies promoting biomedical measures as key indicators of healthcare quality. While all participants saw potential in CSP, they differed in the extent to which they recognised relational and experiential benefits of CSP (beyond biomedical benefits), and their recommendations for continuing its use beyond the clinical trial were contingent on several considerations. Our analysis shows how narrower and broader interpretive emphases and initial skill repertoires can interact with situational challenges and respectively constrain or extend health professionals' ability to refine their skills with experiential learning, reduce or enhance the potential benefits of CSP, and erode or strengthen motivation to use CSP. CONCLUSION: Health professionals' interpretations of CSP, along with their communication skills, interact in complex ways with other features of healthcare systems and diverse patient-circumstance scenarios. They warrant careful attention in efforts to implement and evaluate person-centred support for people with long-term conditions.

Supporting positive experiences and sustained participation in clinical trials: looking beyond information provision.

Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed to generate. Drawing on recent social-psychological and philosophical-ethical research on trial recruitment and patient participation in treatment decision-making, this paper identifies possibilities for improving communicative support for both initial decisions and ongoing participation in clinical trials. It highlights the potential of a shift in thinking about 'voluntariness', underpinned by relational understandings of autonomy, to encourage more nuanced judgements about the ethics of communication between trial staff and (potential) participants. The paper suggests that the idea of responsively enabling people to consider invitations or requests to participate in particular trials could serve as a general guide to communication. This might help ensure decisions about trial participation are meaningfully informed and voluntary, and that relationships between trial staff and participants contribute to positive experiences of trial participation and ultimately to the generation of the robust knowledge.

Unifying and universalizing Personalised Care? An analysis of a national curriculum with implications for policy and education relating to person-centred care.

OBJECTIVE: To examine the Curriculum of England's Personalised Care Institute as a national initiative to promote person-centred practice. METHOD: Analysis of Curriculum content and discourse RESULTS: The Curriculum describes an educational framework which aspires to unify approaches and universalize provision of Personalised Care. It presents 8 "models and approaches" and 6 "components" within the "whole" of Personalised Care. It locates their unity in an underlying common core repertoire of professional capabilities and values and an anchoring belief in people's strengths, resourcefulness and ability to develop their own solutions with appropriate support. The Curriculum indicates some complexity in the provision of Personalised Care but leaves unanswered questions about the theoretical coherence of the concept. It also neglects some important aspects of person-centredness (especially values beyond empowerment and choice); the implications of entrenched social inequalities and systemic prejudices; and other practical-ethical implementation challenges that can be difficult for health professionals. CONCLUSION: The Curriculum signals a national commitment to person-centred practice, but its practical potential is limited by its neglect of the value tensions and diverse situational challenges involved. PRACTICE IMPLICATIONS: The Curriculum and similar policy-education initiatives could be strengthened by more explicit attention to the normative complexities of person-centred practice.

Shared decision making: trade-offs between narrower and broader conceptions.

Shared decision-making approaches, by recognizing the autonomy and responsibility of both health professionals and patients, aim for an ethical 'middle way' between 'paternalistic' and 'consumerist' models of clinical decision making. Shared decision making has been understood in various ways. In this paper, we distinguish narrow and broader conceptions of shared decision making and explore their relative strengths and weaknesses. In the first part of the paper, we construct a summary characterization of an archetypal narrow conception of shared decision making (a conception that does not coincide with any specific published model but which reflects features of a variety of models). We show the shortcomings of such a conception and highlight the need to broaden out our thinking about shared decision making if the ethical (and instrumental) goals of shared decision making are to be realized. In the second part of the paper, we acknowledge and explore the advantages and disadvantages of operating with broader conceptions of shared decision making by considering the analogies between health professional-patient relationships and familiar examples of 'open-ended' relationships (e.g. friendships). We conclude by arguing that the illustrated 'trade-offs' between narrow conceptions (which may protect patients from inappropriately paternalistic professionals but preclude important forms of professional support) and broad conceptions (which render more forms of professional support legitimate but may require skills or virtues that not all health professionals possess) suggest the need to find ways, in principle and in practice, of taking seriously both patient autonomy and autonomy-supportive professional intervention.

An international core outcome set for evaluating interventions to improve informed consent to clinical trials: The ELICIT Study.

OBJECTIVE: To develop a core outcome set for the evaluation of interventions that aim to improve how people make decisions about whether to participate in randomized controlled trials (of healthcare interventions), the ELICIT Study. STUDY DESIGN: International mixed-method study involving a systematic review of existing outcomes, semi-structured interviews, an online Delphi survey, and a face-to-face consensus meeting. RESULTS: The literature review and stakeholder interviews (n = 25) initially identified 1045 reported outcomes that were grouped into 40 individually distinct outcomes. These 40 outcomes were scored for importance in two rounds of an online Delphi survey (n = 79), with 18 people attending the consensus meeting. Consensus was reached on 12 core outcomes: therapeutic misconception; comfort with decision; authenticity of decision; communication about the trial; empowerment; sense of altruism; equipoise; knowledge; salience of questions; understanding, how helpful the process was for decision making; and trial attrition. CONCLUSION: The ELICIT core outcome set is the first internationally agreed minimum set of outcomes deemed essential to be measured in all future studies evaluating interventions to improve decisions about participating in an randomized controlled trial. Use of the ELICIT core set will ensure that results from these trials are comparable and relevant to all stakeholders. REGISTRATION: COMET database - http://www.comet-initiative.org/Studies/Details/595.

Supporting patient autonomy: the importance of clinician-patient relationships.

Personal autonomy is widely valued. Recognition of its vulnerability in health care contexts led to the inclusion of respect for autonomy as a key concern in biomedical ethics. The principle of respect for autonomy is usually associated with allowing or enabling patients to make their own decisions about which health care interventions they will or will not receive. In this paper, we suggest that a strong focus on decision situations is problematic, especially when combined with a tendency to stress the importance of patients' independence in choosing. It distracts attention from other important aspects of and challenges to autonomy in health care. Relational understandings of autonomy attempt to explain both the positive and negative implications of social relationships for individuals' autonomy. They suggest that many health care practices can affect autonomy by virtue of their effects not only on patients' treatment preferences and choices, but also on their self-identities, self-evaluations and capabilities for autonomy. Relational understandings de-emphasise independence and facilitate well-nuanced distinctions between forms of clinical communication that support and that undermine patients' autonomy. These understandings support recognition of the value of good patient-professional relationships and can enrich the specification of the principle of respect for autonomy.

Health in the 'hidden population' of people with low literacy. A systematic review of the literature.

BACKGROUND: Much of the evidence of an association between low functional or health literacy and poor health comes from studies that include people who have various cognitive difficulties or who do not speak the dominant language of their society. Low functional or health literacy among these people is likely to be evident in spoken conversation. However, many other people can talk readily about health and other issues but have problems using written information. Consequently, their difficulties may be far less evident to healthcare professionals, creating a 'hidden population' whose functional or health literacy problems have different implications because they are less likely to be recognised and addressed.We aimed to review published research to investigate relationships between low functional or health literacy and health in working age adults who can converse in the dominant language but have difficulty with written language. METHODS: We searched reviews and electronic databases for studies that examined health-related outcomes among the population of interest. We systematically extracted data relating to relationships between low functional or health literacy and both health status and various possible mediators or moderators of the implications of literacy for health. We developed a narrative review. RESULTS: Twenty-four studies met our inclusion criteria. Lower functional or health literacy in this population was found to be associated with worse health status. This may be mediated by difficulties accessing healthcare, and poorer self-management of health problems. It is currently unclear whether, how or to what extent these difficulties are mediated by poorer knowledge stemming from low functional or health literacy. The variation in functional or health literacy measures and comparisons make it difficult to compare study findings and to establish the implications of different literacy issues for health outcomes. CONCLUSIONS: There is evidence in the literature that low functional or health literacy is associated with poor health in the 'hidden population' of adults whose literacy difficulties may not be evident to health care providers. Further research is needed to help understand the particular disadvantages faced by this population and to establish appropriate responses.

Some Unresolved Ethical Challenges in Healthcare Decision-Making: Navigating Family Involvement.

Family involvement in healthcare decision-making for competent patients occurs to varying degrees in many communities around the world. There are different attitudes about who should make treatment decisions, how and why. Legal and professional ethics codes in most jurisdictions reflect and support the idea that competent patients should be enabled to make their own treatment decisions, even if others, including their healthcare professionals, disagree with them. This way of thinking contrasts with some cultural norms that put more emphasis on the family as a decision-making entity, in some circumstances to the exclusion of a competent patient. Possible tensions may arise between various combinations of patient, family members and healthcare professionals, and healthcare professionals must tread a careful path in navigating family involvement in the decision-making process. These tensions may be about differences of opinion about which treatment option is best and/or on who should have a say or influence in the decision-making process. While some relevant cultural, legal and policy considerations vary from community to community, there are ethical issues that healthcare professionals need to grapple with in balancing the laws and professional codes on decision-making and the ethical principle of respecting patients and their autonomy. This paper will highlight and propose that a partial resolution to these issues may lie in relational understandings of autonomy, which in principle justify interventions by healthcare professionals and family that support patients in decision-making.