Stakeholder perspectives and experiences of the implementation of remote mental health consultations during the COVID-19 pandemic: a qualitative study.

BACKGROUND: Remote mental health consultations were swiftly implemented across mental health services during the COVID-19 pandemic. Research has begun to inform future design and delivery of telemental health services. Exploring the in-depth experiences of those involved is important to understand the complex, multi-level factors that influence the implementation of remote mental health consultations. The aim of this study was to explore stakeholder perspectives and experiences of the implementation of remote mental health consultations during the COVID-19 pandemic in Ireland. METHODS: A qualitative study was conducted whereby semi-structured, individual interviews were undertaken with mental health providers, service users, and managers (n = 19) to acquire rich information. Interviews were conducted between November 2021 and July 2022. The interview guide was informed by the Consolidated Framework for Implementation Research (CFIR). Data were analysed thematically using a deductive and inductive approach. RESULTS: Six themes were identified. The advantages of remote mental health consultations were described, including convenience and increased accessibility to care. Providers and managers described varying levels of success with implementation, citing complexity and incompatibility with existing workflows as barriers to adoption. Providers' access to resources, guidance, and training were notable facilitators. Participants perceived remote mental health consultations to be satisfactory but not equivalent to in-person care in terms of quality. Views about the inferior quality of remote consultations stemmed from beliefs about the inhibited therapeutic relationship and a possible reduction in effectiveness compared to in-person care. Whilst a return to in-person services was mostly preferred, participants acknowledged a potential adjunct role for remote consultations in certain circumstances. CONCLUSIONS: Remote mental health consultations were welcomed as a means to continue care during the COVID-19 pandemic. Their swift and necessary adoption placed pressure on providers and organisations to adapt quickly, navigating challenges and adjusting to a new way of working. This implementation created changes to workflows and dynamics that disrupted the traditional method of mental health care delivery. Further consideration of the importance of the therapeutic relationship and fostering positive provider beliefs and feelings of competence are needed to ensure satisfactory and effective implementation of remote mental health consultations going forward.

Patient and provider perspectives of the implementation of remote consultations for community-dwelling people with mental health conditions: A systematic mixed studies review.

Remote, or tele-, consultations became a necessary form of mental healthcare provision during the COVID-19 pandemic. As the prevalence of mental health problems rises, they may have a role in future mental health services. We aimed to review the literature on patient and provider perspectives on factors influencing the implementation of remote consultations for community-dwelling people with mental health conditions. We searched five electronic databases (PubMed, EMBASE, Web of Science, CINAHL, and PsycINFO) for empirical research up to July 13th, 2022. Only studies of synchronous, interactive remote consultations conducted via video, phone, or live-messaging between patients and providers were included. Two reviewers independently assessed the quality of included studies using the Mixed Methods Appraisal Tool. We integrated qualitative and quantitative data from 39 studies into a single mixed-methods synthesis. We mapped reported factors to the domains of the Consolidated Framework for Implementation Research (CFIR). Acceptability was generally high among participants, despite concerns about the quality of care and the perceived impeded therapeutic relationship. A prominent facilitator was the increased accessibility and convenience of remote consultations, while lack of appropriate infrastructure and low patient comfort and competence were among the most prevalent barriers. This review highlights the importance of patient preferences and provider buy-in to the future of remote consultations.

Impact on the NHS and health of the UK's trade and cooperation relationship with the EU, and beyond.

The UK's relationship with the European Union (EU) is now embodied in two principal legal instruments: the EU-UK Trade and Cooperation Agreement, which formally entered into force on 1 May 2021; and the Withdrawal Agreement, with its Protocol on Ireland/Northern Ireland, which continues to apply. Using a 'building blocks' framework for analysis of national health systems derived from the World Health Organisation, this article examines the likely impacts in the UK of this legal settlement on the National Health Service (NHS), health and social care. Specifically, we determine the extent to which the trade, cooperation and regulatory aspects of those legal measures support positive impacts for the NHS and social care. We show that, as there is clear support for positive health and care outcomes in only one of the 17 NHS 'building blocks', unless mitigating action is taken, the likely outcomes will be detrimental. However, as the legal settlement gives the UK a great deal of regulatory freedom, especially in Great Britain, we argue that it is crucial to track the effects of proposed new health and social care-related policy choices in the months and years ahead.

Framing and legitimating EU legal regulation of human gene-editing technologies: key facets and functions of an imaginary.

Gene-editing technologies, ie those able to make changes in the DNA of an organism, are the object of global competition and a regulatory race between countries and regions. There is an attempt to craft legal frameworks protective enough for users, but flexible enough for developers of gene-editing technologies. This article examines the imaginary built into the framing of EU-level legal regulation of human gene-editing technologies and identifies its three key related facets: the tension around naturalness; safeguarding morality and ethics; and the pursuit of medical objectives for the protection of human health. Concerns around the use of gene-editing technologies in relation to eugenics and human enhancement have produced a multifaceted imaginary. We argue that this imaginary not only places a limit on EU-level regulation, despite a strong EU competence in respect of the internal market, but also seeks to ensure its legitimation.

Expectations as techniques of legitimation? Imagined futures through global bioethics standards for health research.

I argue that expectations or strong beliefs about what can occur, and the imaginaries they construct, can be shaped by organizations and used by them as techniques for public legitimation of their governance and regulatory activities. I advance this argument by reference to the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The expectations and imaginary flowing from the ICH's mission and framing, 'harmonisation for better health', support a focus on technological development for the production of safe, quality, and effective pharmaceuticals and individual ethical conduct to achieve it. The expectations also marginalize wider systemic issues relating to social justice, particularly those affecting the global South. The central role of scientific-technical knowledge and expertise to harmonization abets the latter by minimizing the value to governance of public knowledges on systemic issues. Instead of ensuring the contribution of these knowledges to governance through public participation, there is an attempt to bolster legitimation through communication of expectations and transparency to show practices are in accordance with them (ie expectations are met).

Implementation of telemedicine consultations for people with mental health conditions in the community: a protocol for a systematic review.

Background: The COVID-19 pandemic response has led to an exponential increase in the use and spread of telemedicine internationally. In community mental health care settings, telemedicine services were implemented within a few weeks, with little time for rigorous planning. Despite the reported acceptability of telemedicine by patients and clinicians, barriers to its implementation have come to light. There is now a need to investigate these barriers, and facilitators, as telemedicine begins to show potential promise beyond the pandemic. We propose a review that aims to identify the factors affecting the implementation of telemedicine consultations for patients with mental health conditions in the community. Methods: A systematic review will be conducted and reported according to the PRISMA guidelines. Five electronic databases will be searched using a pre-defined search strategy from 2016 to 2021. Only studies of synchronous, interactive telemedicine consultations conducted via video, phone or live messaging between patients and providers will be included. Quantitative, qualitative and mixed methods studies will be eligible for inclusion. Only studies published in the English language will be included. Titles and abstracts will be screened by two reviewers. Full text articles will be screened by a single reviewer, with a random 20% sample screened by a second reviewer. The methodological quality of studies will be assessed using the Mixed Method Appraisal Tool (MMAT) by two reviewers. Data will be extracted and tabulated to address the aims of the review. A narrative synthesis will be conducted and reported factors will be mapped to the domains of the Consolidated Framework for Implementation Research (CFIR). Conclusion: By identifying the factors that influence the implementation of telemedicine consultations for patients with mental conditions in the community, consideration can be given to both barriers and facilitators that could be addressed in future mental health services planning. PROSPERO registration: CRD42021273422 (04/10/2021).

Health "Brexternalities": The Brexit Effect on Health and Health Care outside the United Kingdom.

The principal effects of Brexit on health and health care will fall within the United Kingdom, and all forms of Brexit have overwhelmingly negative implications for health care and health within the UK. This article focuses on the external effects of Brexit ("Brexternalities") for health and health care. The EU is a particularly powerful institutional and legal arrangement for managing economic and political externalities in health policy as in any other policy. Equally, when a state leaves the EU, the manner of leaving will result in better or worse management of relevant externalities. Brexternalities thus involve questions about policy legitimacy and accountability. Health Brexternalities do not fall equally in all EU countries. They are felt more distinctly in the context of those elements of health policy that are most closely entwined with the UK's health policy (e.g., on the island of Ireland, certain areas of Spain, and other parts of southern Europe). Some health Brexternalities, such as in medicine safety, will be imposed on the whole population of the EU. And some health Brexternalities, such as communicable disease control, will be felt globally.

Assessing the potential impact on health of the UK's future relationship agreement with the EU: analysis of the negotiating positions.

While policy attention is understandably diverted to COVID-19, the end of the UK's post-Brexit 'transition period' remains 31 December 2020. All forms of future EU-UK relationship are worse for health than EU membership, but analysis of the negotiating texts shows some forms are better than others. The likely outcomes involve major negative effects for NHS staffing, funding for health and social care, and capital financing for the NHS; and for UK global leadership and influence. We expect minor negative effects for cross border healthcare (except in Northern Ireland); research collaboration; and data sharing, such as the Early Warning and Response System for health threats. Despite political narratives, the legal texts show that the UK seeks de facto continuity in selected key areas for pharmaceuticals, medical devices, and equipment [including personal protective equipment (PPE)], especially clinical trials, pharmacovigilance, and batch-testing. The UK will be excluded from economies of scale of EU membership, e.g. joint procurement programmes as used recently for PPE. Above all, there is a major risk of reaching an agreement with significant adverse effects for health, without meaningful oversight by or input from the UK Parliament, or other health policy stakeholders.

The EU Clinical Trials Regulation: key priorities, purposes and aims and the implications for public health.

The replacement of the European Union (EU) Clinical Trials Directive by the new Clinical Trials Regulation (CTR), which entered into force on 16 June 2014 but will not apply before 28 May 2016, provides an opportunity to review the legal and political context within which this important aspect of research law and policy sits and to reflect on the implications for public health. My aim in this article is to relate the context to the key purposes and aims of EU law and policy on clinical trials in order to explain and clarify its orientation. On that basis, I argue that the CTR and the changes it introduces to the law on clinical trials are part of the EU's continued focus on market optimisation. It is this focus that orients and directs the wider pharmaceutical development pipeline, but that undermines the achievement of key public health objectives.

Regulatory or regulating publics? The European Union's regulation of emerging health technologies and citizen participation.

'Citizen participation' includes various participatory techniques and is frequently viewed as an unproblematic and important social good when used as part of the regulation of the innovation and implementation of science and technology. This is perhaps especially evident in debates around 'anticipatory governance' or 'upstream engagement'. Here, we interrogate this thesis using the example of the European Union's regulation of emerging health technologies (such as nanotechnology). In this case, citizen participation in regulatory debate is concerned with innovative objects for medical application that are considered to be emergent or not yet concrete. Through synthesising insights from law, regulatory studies, critical theory, and science and technology studies, we seek to cast new light on the promises, paradoxes, and pitfalls of citizen participation as a tool or technology of regulation in itself. As such we aim to generate a new vantage point from which to view the values and sociotechnical imaginaries that are both 'designed-in' and 'designed-out' of citizen participation. In so doing, we show not only how publics (do not) regulate technologies, but also how citizens themselves are regulated through the techniques of participation.