Getting rights right: implementing 'Martha's Rule'.

The UK government has recently committed to adopting a new policy-dubbed 'Martha's Rule'-which has been characterised as providing patients the right to rapidly access a second clinical opinion in urgent or contested cases. Support for the rule emerged following the death of Martha Mills in 2021, after doctors failed to admit her to intensive care despite concerns raised by her parents. We argue that framing this issue in terms of patient rights is not productive, and should be avoided. Insofar as the ultimate goal of Martha's Rule is the provision of a clinical service that protects patient safety, an approach that focuses on the obligations of the health system-rather than the individual rights of patients-will better serve this goal. We outline an alternative approach that situates rapid clinical review as part of a suite of services aimed at enhancing and protecting patient care. This approach would make greater progress towards addressing the difficult systemic issues that Martha's Rule does not, while also better engaging with the constraints of clinical practice.

Accessing healthcare during the COVID-19 pandemic: a qualitative exploration of the experiences of parents and carers of children with chronic illness to inform future policies in times of crisis.

BACKGROUND: The purpose of thispaper is to explore the experiences of parents and carers of children with chronic health conditions in accessing healthcare during the Covid-19 pandemic. Children with chronic conditions typically rely on both planned and unplanned care, and contact with healthcare professionals over extensive periods of time. Their distinct care needs render these children vulnerable to even to minor changes in healthcare provision. The wide-ranging care disruptions during the pandemic were therefore likely drastically to affect their health and wellbeing; an assessment of the effects of Covid-19 policies on healthcare access and quality of care delivered for this group is needed. METHODS: From 25/01/2022 to 25/05/2022, four focus groups were held with parents/carers of children with diabetes, neurodivergence, mental health conditions, and medical complexities to explore their experiences in navigating the healthcare system during the pandemic. Interviews were transcribed and then subjected to thematic analysis using NVivo qualitative research software. RESULTS: Our results indicate that children with chronic health conditions (and their parents/carers) experienced difficulties accessing healthcare during the pandemic. Problems with late diagnosis, prolonged waiting times, and deficiencies with telemedicine were identified, as were impacts of healthcare disruptions on children's wellbeing, and the wellbeing of wider families. We found that children with neurodivergence and those with mental health conditions were particularly affected with their health needs repeatedly de-prioritised. Furthermore, the loss of contact with multi-specialty clinical teams profoundly affected parents and carers, leaving them feeling isolated in managing their children's health. These diminished relationships became another vector for uncertainty in supporting children's health. CONCLUSION: The effects of healthcare disruptions on the welfare of children with chronic conditions (and their families), are well evidenced in this work, providing deeper understandings of the relationships between these children, their families and clinicians. The evidence in this paper aims to inform future policy and ethical guidelines so that the needs of children with long-term health conditions can be properly considered in times of crisis.

Children with medical complexities: their distinct vulnerability in health systems' Covid-19 response and their claims of justice in the recovery phase.

In this paper, we discuss the lack of consideration given to children in the COVID-19 health systems policy response to the pandemic. We do this by focusing on the case of children with complex medical needs. We argue that, in broad terms, health systems policies that were implemented during the pandemic failed adequately to meet our obligations to both children generally and those with complex medical needs by failing to consider those needs and so to give them fair protection against harm and disadvantage. We argue that justice requires that the distinct needs and vulnerabilities of children with medical complexities are explicitly integrated and prioritised in decisions concerning healthcare and operational planning in the recovery phase and beyond.

Healthcare resource allocation decisions and non-emergency treatments in the aftermath of Covid-19 pandemic. How should children with chronic illness feature in prioritisation processes?

Background: In the aftermath of the Coronavirus disease 2019 (Covid-19) pandemic, allocation of non-urgent medical interventions is a persistent ethical challenge as health systems currently face an unprecedented backlog of patients requiring treatment. Difficult decisions must be made that prioritise certain patients over others. Ethical resource allocation requires that the needs of all patients are considered properly, but at present there is no guidance that can help support such decision-making which explicitly considers the needs of children with chronic and complex conditions. Methods: This paper reviews the NHS guidance for priorities and operational planning and examines how the needs of children with chronic illness are addressed in NHS objectives for restoring services and meeting elective care demands. Results: The usual criteria for prioritisation featured in the NHS guidance fail to account for the distinct needs of children with chronic illnesses and fail to match more general considerations of what constitutes fair resource allocation decisions. To address this issue, two considerations, namely 'protecting age-related opportunity' and 'recognising complexity of care,' are proposed as additions to the existing approach. Conclusion: By providing a broader conception of needs, these criteria address inefficiencies of the current guidance and relevant ethical frameworks and help to embed a currently missing children-related ethical approach to healthcare policy making in general.

This paper addresses an increasingly pressing practical problem of justly allocating healthcare resources between different groups in the aftermath of the pandemic and in the face of significant waiting lists for treatment. Our focus is on children with complex conditions, a vulnerable group that we argue has been systematically disadvantaged in policy considerations. We claim that the current NHS approach does not succeed in capturing their distinct needs. We suggest that two new criteria 'protecting age-related equality of opportunity' and 'acknowledging complexity of care' should complement the existing ones in order to support decisions-makers to make decisions that are consistent, fair and inclusive to the needs of children with chronic conditions. We also consider broader implications of our suggested framework for health care resource allocation decisions in general. We hope that this work brings a better theoretical understanding closer to the practical changes faced in resource allocation decision making context in the aftermath of the pandemic and beyond.

Changes in Healthcare Provision During Covid-19 and Their Impact on Children With Chronic Illness: A Scoping Review.

This paper provides an overview of the evidence around how the health systems and policy response to the Covid-19 pandemic affected children with long-term conditions in the UK. We conducted a scoping review guided by the PRISMA-ScR Checklist. The PubMed and PsycINFO databases (2019-August 2021) were searched and screened for papers (of any design) by 2 reviewers independently. The electronic database search was supplemented by manual searching. A total of 32 papers were identified, including studies on UK paediatric populations, studies on chronic illness in the UK, and international studies on chronic illness and children (including data from the UK). Most studies focussed on epilepsy, cancer, diabetes or asthma. Three categories of impact were identified: (a) impact of policy response on the delivery of and access to child healthcare (b) impact of innovative practice on children's physical and mental health (c) impact of service restrictions on children's physical health. Our results showed that policy response to the pandemic significantly affected healthcare provision for children with chronic illness in the UK. However, the specific assessment of the impact of service restrictions and innovative practice on children's health and wellbeing is limited. Future research is required to fill knowledge gaps on changes in access to effective diagnostic and treatment investigations and their impact on a range of paediatric patients during the pandemic.

The Post-Normal Challenges of COVID-19: Constructing Effective and Legitimate Responses.

The ongoing COVID-19 emergency clearly presents novel challenges, both in terms of difficulties for maintaining public health and in assuring that governmental responses are ethically sound. Centrally, responses must respect, as best as possible, fundamental human rights and human values. Conflicts among values arise in response to the crisis, and public officials have no choice but to prioritize some while sacrificing others. Utilizing the concepts of effectiveness and legitimacy within the framework of post-normal science (PNS), we investigate and recommend processes and measures to address COVID-19 that support increased public health, while upholding established rights and values. The effectiveness and legitimacy of science-led policymaking requires investigation of how that policy ought to be made (e.g. concepts of policymaking and PNS), as well as how it ought to interact with diversely-constituted publics (e.g. public inclusion in policymaking and policy communication).

Measuring the impact of participatory research in psychiatry: How the search for epistemic justifications obscures ethical considerations.

CONTEXT: Both within politics and practice, the field of psychiatry is undergoing a significant transformation, as increasing emphasis is placed on the importance of involving those with lived experience in research. In response to this participatory turn, a push towards measuring the impact of patient involvement is also growing, seeking to identify how participation can improve research. OBJECTIVE: This paper examines the recent push towards measuring impact in relation to justifications underlying the democratization of research in psychiatry, revealing a disconnect between the two, and harms that could result from a singular focus on measuring impact. DISCUSSION: While those promoting and regulating participatory research tend to focus on the epistemic benefits of such research, many have pointed to both epistemic and ethical justifications underlying participatory research. The ethical reasons for involving service users loom especially large in psychiatry, given its unique history of abuse, the ways diagnoses can be utilized as tools for oppression, and the prevalence of coercion. The current focus on measuring the impact of involvement can be harmful, in that it obscures ethical reasons in favour of epistemic ones, potentially exacerbating issues common to participatory research, such as role confusion and ineffective, tokenistic participatory efforts. CONCLUSIONS: We argue that to take the ethical reasons behind involvement in mental health research seriously will involve looking beyond impact and towards sharing power. We suggest three ways this can be done: measuring more than impact, building service user capacities and sharing power in realms outside of research.

Public involvement in the governance of population-level biomedical research: unresolved questions and future directions.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

Why research ethics should add retrospective review.

Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a 'tick box' exercise to get over the 'hurdle' of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people's capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project's ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others' perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion.

Principles for provision of integrated complex care for children across the acute-community interface in Europe.

This Viewpoint presents and discusses the development of the first core principles and standards for effective, personalised care of children living with complex care needs in Europe. These principles and standards emerged from an analysis of data gathered on several areas, including the integration of care for the child at the acute-community interface, the referral-discharge interface, the social care interface, nursing preparedness for practice, and experiences of the child and family. The three main principles, underpinned by a child-centric approach, are access to care, co-creation of care, and effective integrated governance. Collectively, the principles and standards offer a means to benchmark existing services for children living with complex care needs, to influence policy in relation to service delivery for these children, and to provide a suite of indicators with which to assess future service developments in this area.

Informed consent in cluster randomised trials: new and common ethical challenges.

Cluster randomised trials are an increasingly important methodological tool in health research but they present challenges to the informed consent requirement. In the relatively limited literature on the ethics of cluster research there is not much clarity about the reasons for which seeking informed consent in cluster randomised trials may be morally challenging. In this paper, I distinguish between the cases where informed consent in cluster trials may be problematic due to the distinct features of 'population-based' interventions, which have not been adequately discussed in the research ethics literature, and the cases where informed consent may be problematic for reasons that investigators also encounter in other research designs. I claim that informed consent requirements in cluster trials should be adjusted to the level of risk involved, arguing for a more comprehensive notion of research risk than that currently found in the research ethics guidelines, and the amount of freedom to be sacrificed in relation to a particular research aim. I conclude that these two factors are the most important to consider when assessing whether a cluster study should proceed when informed consent is infeasible or difficult to obtain.

Reconstructing communities in cluster trials?

BACKGROUND: There is growing interest in the ethics of cluster trials, but no literature on the uncertainties in defining communities in relation to the scientific notion of the cluster in collaborative biomedical research. METHODS: The views of participants in a community-based cluster randomised trial (CRT) in Mumbai, India, were solicited regarding their understanding and views on community. We conducted two focus group discussions with local residents and 20 semi-structured interviews with different respondent groups. On average, ten participants took part in each focus group, most of them women aged 18-55. We conducted semi-structured interviews with ten residents (nine women and one man) lasting approximately an hour each and seven individuals (five men and two women) identified by residents as local leaders or decision-makers. In addition, we interviewed two Municipal Corporators (locally elected government officials involved in urban planning and development) and one representative of a political party located in a slum community. RESULTS: Residents' sense of community largely matched the scientific notion of the cluster, defined by the investigators as a geographic area, but their perceived needs were not entirely met by the trial. CONCLUSION: We examined whether the possibility of a conceptual mismatch between 'clusters' and 'communities' is likely to have methodological implications for a study or to lead to potential social disharmony because of the research interventions, arguing that it is important to take social factors into account as well as statistical efficiency when choosing the size and type of clusters and designing a trial. One method of informing such a design would be to use existing forums for community engagement to explore individuals' primary sense of community or social group and, where possible, to fit clusters around them. TRIAL REGISTRATION: ISRCTN Register: ISRCTN56183183 Clinical Trials Registry of India: CTRI/2012/09/003004 .