Teeth are for chewing: a critical review of the conceptualisation and ethics of a controversial intraoral weight-loss device.

We are a diverse collective of researchers who are committed to improving the health and wellbeing of marginalised individuals. This article is a response to, and critique of, the DentalSlim Diet Control research. This device revises a controversial 1970s weight-loss technology connected to poor health outcomes, which is indicative of a culture that consistently promotes harm to fat and other marginalised communities.We address the historical context in which unruly bodies, particularly fat, and Indigenous bodies have been the site of unethical investigation conducted under the auspices of medical research. Existence outside the normative white, male, cis physical ideal demands regulation, and disciplinary measures. We demonstrate how Brunton et al.'s research is underpinned by anti-fat attitudes and assumptions which impose this punitive physical intervention onto healthy people in a way that should not be acceptable in medical research.Further, we address a range of harms, giving attention to Maori and to individuals with eating disorders, along with issues of research integrity. We argue that no ethics committee should have approved this research, no academic journal should have published it, and no member of the dental and medical community should promote or prescribe this device.

Creating a Research Ethics Consultation Service: Issues to Consider.

This article provides pragmatic advice for organizations interested in creating a research ethics consultation service (RECS). A robust RECS has the potential to build capacity among investigators to identify and consider the ethical issues they encounter while conducting their research. Determining whether to establish an RECS should begin with an institutional-needs assessment that includes three key questions: What are the current resources available to research teams to navigate ethical concerns that arise from their research? Is there a demand or perceived need for more resources? Is there institutional support (financial and otherwise) to establish and maintain an RECS? If this results in the decision to establish the consultation service, relevant institutional stakeholders must be identified and consulted, and personnel with the requisite skills recruited. The next step is to establish an RECS and build the infrastructure to process and respond to requests. The RECS's long-term sustainability will depend on a stable source of funding and a mechanism to receive constructive feedback to ensure that the service is meeting the institutional needs it set out to address.

How rural nurses in Southern New Zealand navigate their ethical landscape-A qualitative study.

OBJECTIVE: To explore rural nurse experiences of ethical issues and their management of these as a first step in a programme of work to address rural nurses' ethical needs. DESIGN: This study was qualitative, using mixed qualitative techniques to gather data, which was analysed using a general inductive approach. SETTING: Primary health care in 2 regions of Aotearoa New Zealand. PARTICIPANTS: Eleven nurses working in the West Coast (District Health Board) region and 9 working within the Southern District Health Board region. INTERVENTION: Participants took part in either a focus groups or an interview with members of the research team. MAIN OUTCOME MEASURES: To document ethical issues that confronted these rural nurses and how they navigated these issues. RESULTS: Three themes were identified: 'Signals and Silences,' 'One and Other' and 'Frustrations and Freedoms.' A continuous thread through these themes was the concept of phronesis, or what is sometimes called practical virtue. This practical virtue largely developed through their own experiences, rather than through educational or health system specific support or resources. CONCLUSIONS: We found that rural nurses' deal with specific issues related to the rural setting, such as resourcing and isolation, while maintaining a relationship with the communities they serve and their professional autonomy. Additionally, we discovered the ways in which rural nurses deal with the ethical issues they encounter to be practically focussed. However, rural nurses need supportive leadership not only to sustain the moral agency they demonstrate but also to further develop their ethical decision-making practices. The provision of a clinical ethics tele-service delivering both training opportunities and an on-call consult support service would provide a potential solution.

'A balancing act'. Living with severe chronic obstructive pulmonary disease in Southern New Zealand: a qualitative study.

INTRODUCTION Chronic obstructive pulmonary disease (COPD) is a common chronic condition managed in primary care. AIM To understand how patients with severe COPD living in the Southern Health Region (Otago and Southland) experience and cope with the condition. METHODS Semi-structured interviews were undertaken with 23 patients with severe COPD (defined using the 2013 GOLD classification). A thematic analysis was conducted. RESULTS Patients' accounts of living with severe COPD revealed four themes: loss, adaptation, isolation and social support. All participants discussed their sense of loss in coming to terms with having COPD and the ongoing restrictions or changes that were associated with breathlessness and fatigue. These losses required adaptation in daily living. Some patients struggled to adjust to new limitations and needed to rely on others for support. Others found ways to adapt their surroundings or ways of doing things while trying to maintain the same activities. Isolation was described in two ways - direct (no longer being able to easily socialize because activities often caused breathlessness) and indirect (the feeling of being isolated from others because they do not understand what it is like to live with COPD). Social support, including support provided by group-based pulmonary rehabilitation, helped to address the problems of social isolation. DISCUSSION Living with severe COPD is a 'balancing act' between insecurity (loss and isolation) and resilience (adaptation and social support). Health-care providers need to be proactive in identifying and managing patients' unmet health needs and promote activities that reduce social isolation.

Health Care Utilisation and Health Needs of People with Severe COPD in the Southern Region of New Zealand: A Retrospective Case Note Review.

We examined health care utilisation and needs of people with severe COPD in the low-population-density setting of the Southern Region of New Zealand (NZ). We undertook a retrospective case note review of patients with COPD coded as having an emergency department attendance and/or admission with at least one acute exacerbation during 2015 to hospitals in the Southern Region of NZ. Data were collected and analysed from 340 case notes pertaining to: demographics, hospital admissions, outpatient contacts, pulmonary rehabilitation, advance care planning and comorbidities. Geometric mean (95%CI) length of stay for hospital admissions in urban and rural hospitals was 3.0 (2.7-3.4) and 4.0 (2.9-5.4) days respectively. More patients were from areas of higher deprivation but median hospital length of stay for patients from the least deprived areas was 2.0 days longer than others (p = 0.04). There was a median of 4 (range 0-16) comorbidities and 10 medications (range 0-25) per person. Of 169 cases where data was available, 26 (15%) were offered, 17 (10%) declined, and 5 (3%) completed, pulmonary rehabilitation at or in the year prior to the index admission. Patients were less likely to be offered pulmonary rehabilitation if they lived >20km away from the hospital where it took place (odds ratio of 0.12 for those living further away [95%CI 0.02-0.93, p = 0.04]). There were deficits in care: provision and uptake of non-pharmacological interventions was suboptimal and unevenly distributed across the region. Further research is needed to develop and evaluate strategies for delivering non-pharmacological interventions in this setting.

Improving access to health care for people with severe chronic obstructive pulmonary disease (COPD) in Southern New Zealand: qualitative study of the views of health professional stakeholders and patients.

OBJECTIVES: Chronic obstructive pulmonary disease (COPD) is a common chronic disease with significant morbidity and mortality, particularly for Maori, which places a large burden on the New Zealand (NZ) health system. We undertook a qualitative study as part of a mixed-methods implementation research project which aimed to determine the barriers and enablers to the provision of accessible high-quality COPD care. SETTING: Southern Health Region of NZ (Otago and Southland). PARTICIPANTS: Thirteen health professional stakeholders and 23 patients with severe COPD (including one Maori and one Pasifika participant). METHODS: Semistructured interviews were undertaken. A thematic analysis using the Levesque conceptual framework for access to healthcare was conducted. RESULTS: Health professional stakeholders identified barriers to providing access to health services, in particular: availability (inadequate staffing and resourcing of specialist services and limited geographical availability of pulmonary rehabilitation), affordability (both of regular medication, medication needed for an exacerbation of COPD and the copayment charge for seeing a general practitioner) and appropriateness (a shared model of care across primary and secondary care was needed to facilitate better delivery of key interventions such as pulmonary rehabilitation and advance care planning (ACP). Maori stakeholders highlighted the importance of communication and relationships and the role of whanau (extended family) for support. Patients' accounts showed variable ability to access services through having a limited understanding of what COPD is, a limited knowledge of services they could access, being unable to attend pulmonary rehabilitation (due to comorbidities) and direct (medication and copayment charges) and indirect (transport) costs. CONCLUSIONS: People with severe COPD experience multilevel barriers to accessing healthcare in the NZ health system along the pathway of care from diagnosis to ACP. These need to be addressed by local health services if this group of patients are to receive high-quality care.

Creating sustainable health care systems.

PURPOSE: In order to create sustainable health systems, many countries are introducing ways to prioritise health services underpinned by a process of health technology assessment. While this approach requires technical judgements of clinical effectiveness and cost effectiveness, these are embedded in a wider set of social (societal) value judgements, including fairness, responsiveness to need, non-discrimination and obligations of accountability and transparency. Implementing controversial decisions faces legal, political and public challenge. To help generate acceptance for the need for health prioritisation and the resulting decisions, the purpose of this paper is to develop a novel way of encouraging key stakeholders, especially patients and the public, to become involved in the prioritisation process. DESIGN/METHODOLOGY/APPROACH: Through a multidisciplinary collaboration involving a series of international workshops, ethical and political theory (including accountability for reasonableness) have been applied to develop a practical way forward through the creation of a values framework. The authors have tested this framework in England and in New Zealand using a mixed-methods approach. FINDINGS: A social values framework that consists of content and process values has been developed and converted into an online decision-making audit tool. RESEARCH LIMITATIONS/IMPLICATIONS: The authors have developed an easy to use method to help stakeholders (including the public) to understand the need for prioritisation of health services and to encourage their involvement. It provides a pragmatic way of harmonising different perspectives aimed at maximising health experience. PRACTICAL IMPLICATIONS: All health care systems are facing increasing demands within finite resources. Although many countries are introducing ways to prioritise health services, the decisions often face legal, political, commercial and ethical challenge. The research will help health systems to respond to these challenges. SOCIAL IMPLICATIONS: This study helps in increasing public involvement in complex health challenges. ORIGINALITY/VALUE: No other groups have used this combination of approaches to address this issue.

HealthPathways implementation in a New Zealand health region: a qualitative study using the Consolidated Framework for Implementation Research.

OBJECTIVES: To explore the process of implementation of an online health information web-based portal and referral system (HealthPathways) using implementation science theory: the Consolidated Framework for Implementation Research (CFIR). SETTING: Southern Health Region of New Zealand (Otago and Southland). PARTICIPANTS: Key Informants (providers and planners of healthcare) (n=10) who were either involved in the process of implementing HealthPathways or who were intended end-users of HealthPathways. METHODS: Semistructured interviews were undertaken. A deductive thematic analysis using CFIR was conducted using the framework method. RESULTS: CFIR postulates that for an intervention to be implemented successfully, account must be taken of the intervention's core components and the adaptable periphery. The core component of HealthPathways-the web portal and referral system that contains a large number of localised clinical care pathways-had been addressed well by the product developers. Little attention had, however, been paid to addressing the adaptable periphery (adaptable elements, structures and systems related to HealthPathways and the organisation into which it was being implemented); it was seen as sufficient just to deliver the web portal and referral system and the set of clinical care pathways as developed to effect successful implementation. In terms of CFIR's 'inner setting' corporate and professional cultures, the implementation climate and readiness for implementation were not properly addressed during implementation. There were also multiple failures of the implementation process (eg, lack of planning and engagement with clinicians). As a consequence, implementation of HealthPathways was highly problematic. CONCLUSIONS: The use of CFIR has furthered our understanding of the factors needed for the successful implementation of a complex health intervention (HealthPathways) in the New Zealand health system. Those charged with implementing complex health interventions should always consider the local context within which they will be implemented and tailor their implementation strategy to address these.

Multimorbidity, clinical decision making and health care delivery in New Zealand Primary care: a qualitative study.

BACKGROUND: Multimorbidity is a major issue for primary care. We aimed to explore primary care professionals' accounts of managing multimorbidity and its impact on clinical decision making and regional health care delivery. METHODS: Qualitative interviews with 12 General Practitioners and 4 Primary Care Nurses in New Zealand's Otago region. Thematic analysis was conducted using the constant comparative method. RESULTS: Primary care professionals encountered challenges in providing care to patients with multimorbidity with respect to both clinical decision making and health care delivery. Clinical decision making occurred in time-limited consultations where the challenges of complexity and inadequacy of single disease guidelines were managed through the use of "satisficing" (care deemed satisfactory and sufficient for a given patient) and sequential consultations utilising relational continuity of care. The New Zealand primary care co-payment funding model was seen as a barrier to the delivery of care as it discourages sequential consultations, a problem only partially addressed through the use of the additional capitation based funding stream of Care Plus. Fragmentation of care also occurred within general practice and across the primary/secondary care interface. CONCLUSIONS: These findings highlight specific New Zealand barriers to the delivery of primary care to patients living with multimorbidity. There is a need to develop, implement and nationally evaluate a revised version of Care Plus that takes account of these barriers.

Introduction: priority setting, equitable access and public involvement in health care.

Purpose - The purpose of this paper is to introduce the special issue on improving equitable access to health care through increased public and patient involvement (PPI) in prioritization decisions by discussing the conceptualization, scope and rationales of PPI in priority setting that inform the special issue. Design/methodology/approach - The paper employs a mixed-methods approach in that it provides a literature review and a conceptual discussion of the common themes emerging in the field of PPI and health priority setting. Findings - The special issue focuses on public participation that is collective in character, in the sense that the participation relates to a social, not personal, decision and is relevant to whole groups of people and not single individuals. It is aimed at influencing a decision on public policy or legal rules. The rationales for public participation can be found in democratic theory, especially as they relate to the social and political values of legitimacy and representation. Originality/value - The paper builds on previous definitions of public participation by underlining its collective character. In doing so, it develops the work by Parry, Moyser and Day by arguing that, in light of the empirical evidence presented in this issue, public participatory activities such as protests and demonstrations should no longer be labelled unconventional, but should instead be labelled as "contestatory participation". This is to better reflect a situation in which these modes of participation have become more conventional in many parts of the world.

Patterns of public participation.

Purpose - The paper summarizes data from 12 countries, chosen to exhibit wide variation, on the role and place of public participation in the setting of priorities. The purpose of this paper is to exhibit cross-national patterns in respect of public participation, linking those differences to institutional features of the countries concerned. Design/methodology/approach - The approach is an example of case-orientated qualitative assessment of participation practices. It derives its data from the presentation of country case studies by experts on each system. The country cases are located within the historical development of democracy in each country. Findings - Patterns of participation are widely variable. Participation that is effective through routinized institutional processes appears to be inversely related to contestatory participation that uses political mobilization to challenge the legitimacy of the priority setting process. No system has resolved the conceptual ambiguities that are implicit in the idea of public participation. Originality/value - The paper draws on a unique collection of country case studies in participatory practice in prioritization, supplementing existing published sources. In showing that contestatory participation plays an important role in a sub-set of these countries it makes an important contribution to the field because it broadens the debate about public participation in priority setting beyond the use of minipublics and the observation of public representatives on decision-making bodies.

Public involvement in health priority setting: future challenges for policy, research and society.

Purpose - The purpose of this paper is to reflect on the findings of this special issue and discusses the future challenges for policy, research and society. The findings suggest that challenges emerge as a result of legitimacy deficits of both consensus and contestatory modes of public involvement in health priority setting. Design/methodology/approach - The paper draws on the discussions and findings presented in this special issue. It seeks to bring the country experiences and case studies together to draw conclusions for policy, research and society. Findings - At least two recurring themes emerge. An underlying theme is the importance, but also the challenge, of establishing legitimacy in health priority setting. The country experiences suggest that we understand very little about the conditions under which representative, or authentic, participation generates legitimacy and under which it will be regarded as insufficient. A second observation is that public participation takes a variety of forms that depend on the opportunity structures in a given national context. Given this variety the conceptualization of public participation needs to be expanded to account for the many forms of public participation. Originality/value - The paper concludes that the challenges of public involvement are closely linked to the question of how legitimate processes and decisions can be generated in priority setting. This suggests that future research must focus more narrowly on conditions under which legitimacy are generated in order to expand the understanding of public involvement in health prioritization.