Training for managing impacted fetal head at caesarean birth: multimethod evaluation of a pilot.

BACKGROUND: Implementation of national multiprofessional training for managing the obstetric emergency of impacted fetal head (IFH) at caesarean birth has potential to improve quality and safety in maternity care, but is currently lacking in the UK. OBJECTIVES: To evaluate a training package for managing IFH at caesarean birth with multiprofessional maternity teams. METHODS: The training included an evidence-based lecture supported by an animated video showing management of IFH, followed by hands-on workshops and real-time simulations with use of a birth simulation trainer, augmented reality and management algorithms. Guided by the Kirkpatrick framework, we conducted a multimethod evaluation of the training with multiprofessional maternity teams. Participants rated post-training statements about relevance and helpfulness of the training and pre-training and post-training confidence in their knowledge and skills relating to IFH (7-point Likert scales, strongly disagree to strongly agree). An ethnographer recorded sociotechnical observations during the training. Participants provided feedback in post-training focus groups. RESULTS: Participants (N=57) included 21 midwives, 25 obstetricians, 7 anaesthetists and 4 other professionals from five maternity units. Over 95% of participants agreed that the training was relevant and helpful for their clinical practice and improving outcomes following IFH. Confidence in technical and non-technical skills relating to managing IFH was variable before the training (5%-92% agreement with the pre-training statements), but improved in nearly all participants after the training (71%-100% agreement with the post-training statements). Participants and ethnographers reported that the training helped to: (i) better understand the complexity of IFH, (ii) recognise the need for multiprofessional training and management and (iii) optimise communication with those in labour and their birth partners. CONCLUSIONS: The evaluated training package can improve self-reported knowledge, skills and confidence of multiprofessional teams involved in management of IFH at caesarean birth. A larger-scale evaluation is required to validate these findings and establish how best to scale and implement the training.

Priority setting and cross-country learning: the relevance of TO-REACH for primary care.

AIM: To inform the primary care community about priorities for research in primary care as came up from the European project TO-REACH and to discuss transferability of service and policy innovations between countries. BACKGROUND: TO-REACH stands for Transfer of Organizational innovations for Resilient, Effective, equitable, Accessible, sustainable and Comprehensive Health services and systems. This EU-funded project has put health systems and services research higher on the European agenda and has led to the current development of a European 'Partnership Transforming Health and Care Systems'. METHODS: To identify research priorities, both qualitative and quantitative approaches were used. Policy documents and strategic roadmaps were searched, and priorities were mapped. Stakeholders were involved through national roundtable consultations and online consultations. Regarding transferability, we carried out a review of the literature, guided by a conceptual framework, and using a snowballing approach. FINDINGS: Primary care emerged as an important priority from the inventory, as are areas that are conducive to strengthening primary care, such as workforce policies. The large variation in service organisation and policy around primary care in Europe is a huge potential for cross-country learning. However, the simple transfer of primary care service and policy arrangements from one health system to another has a big chance to fail, unless known conditions for successful transfer are taken into account and gaps in our knowledge about transfer are resolved.

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.

Understanding multi-stakeholder needs, preferences and expectations to define effective practices and processes of patient engagement in medicine development: A mixed-methods study.

BACKGROUND: The holistic evolution of patient engagement in medicines development requires a more detailed understanding of the needs of all involved stakeholders, and one that better accounts for the specific needs of some potentially vulnerable patient populations and key stages in medicines development. OBJECTIVE: The purpose of this convergent mixed-methods study was to better understand the needs of different stakeholders concerning patient engagement at three key stages in medicines development: research priority setting, clinical trial design and early dialogues with Health Technology Assessment bodies and regulators. DESIGN: This study brought together findings from three sources: i) an online questionnaire, ii) face-to-face consultations with two potentially vulnerable patient populations, a workshop with Health Technology Assessment bodies, and iii) three-step modified Delphi methodology. RESULTS: Overall stakeholders still need additional varied support mechanisms to undertake, sustain or measure value of patient engagement. Health Technology Assessment bodies need better rationale for patient engagement in early dialogue and tools to support its implementation. Improved awareness and understanding of the need and value that involving patients, who are often considered as potentially vulnerable, can bring is needed, as is better accommodation of their specific needs. Similarly, weighted Delphi categories were as follows: aims and objectives, and sustainability. Several additional themes were common across the three key stages in medicines development. CONCLUSION: This broad-reaching study provides the blocks needed to build a framework for patient engagement in medicines development. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in review and interpretation of data.

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.

Use of digital health tools in Europe: before, during and after COVID-19

This policy brief takes stock of how digital health tools have been used during the COVID-19 pandemic, in order to review what has happened, assess how uptake and use of these tools has been facilitated, identify issues that are emerging, and learn lessons for the longer term to support the sustained use of digital health tools.

Governing the public-private-partnerships of the future: learnings from the experiences in pandemic times

No-one is safe until everyone is safe. But what can be done when a country fails to take measures to control a pandemic virus? It poses a threat to its own people but also to its neighbours and beyond. Countries do pool sovereignty, working through supra-national structures, such as international agencies, or using processes set out in treaties, recognising the mutual benefits of the international rules-based system. Here we review the ways in which governments have, or have not worked together on other issues that pose a threat to global health and discuss the implications for pandemic responses.

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.

Evaluating the "return on patient engagement initiatives" in medicines research and development: A literature review.

BACKGROUND: Showing how engagement adds value for all stakeholders can be an effective motivator for broader implementation of patient engagement. However, it is unclear what methods can best be used to evaluate patient engagement. This paper is focused on ways to evaluate patient engagement at three decision-making points in the medicines research and development process: research priority setting, clinical trial design and early dialogues with regulators and health technology assessment bodies. OBJECTIVE: Our aim was to review the literature on monitoring and evaluation of patient engagement, with a focus on indicators and methods. SEARCH STRATEGY AND INCLUSION CRITERIA: We undertook a scoping literature review using a systematic search, including academic and grey literature with a focus on evaluation approaches or outcomes associated with patient engagement. No date limits were applied other than a cut-off of publications after July 2018. DATA EXTRACTION AND SYNTHESIS: Data were extracted from 91 publications, coded and thematically analysed. MAIN RESULTS: A total of 18 benefits and 5 costs of patient engagement were identified, mapped with 28 possible indicators for their evaluation. Several quantitative and qualitative methods were found for the evaluation of benefits and costs of patient engagement. DISCUSSION AND CONCLUSIONS: Currently available indicators and methods are of some use in measuring impact but are not sufficient to understand the pathway to impact, nor whether interaction between researchers and patients leads to change. We suggest that the impacts of patient engagement can best be determined not by applying single indicators, but a coherent set of measures.

Frameworks for supporting patient and public involvement in research: Systematic review and co-design pilot.

BACKGROUND: Numerous frameworks for supporting, evaluating and reporting patient and public involvement in research exist. The literature is diverse and theoretically heterogeneous. OBJECTIVES: To identify and synthesize published frameworks, consider whether and how these have been used, and apply design principles to improve usability. SEARCH STRATEGY: Keyword search of six databases; hand search of eight journals; ancestry and snowball search; requests to experts. INCLUSION CRITERIA: Published, systematic approaches (frameworks) designed to support, evaluate or report on patient or public involvement in health-related research. DATA EXTRACTION AND SYNTHESIS: Data were extracted on provenance; collaborators and sponsors; theoretical basis; lay input; intended user(s) and use(s); topics covered; examples of use; critiques; and updates. We used the Canadian Centre for Excellence on Partnerships with Patients and Public (CEPPP) evaluation tool and hermeneutic methodology to grade and synthesize the frameworks. In five co-design workshops, we tested evidence-based resources based on the review findings. RESULTS: Our final data set consisted of 65 frameworks, most of which scored highly on the CEPPP tool. They had different provenances, intended purposes, strengths and limitations. We grouped them into five categories: power-focused; priority-setting; study-focused; report-focused; and partnership-focused. Frameworks were used mainly by the groups who developed them. The empirical component of our study generated a structured format and evidence-based facilitator notes for a "build your own framework" co-design workshop. CONCLUSION: The plethora of frameworks combined with evidence of limited transferability suggests that a single, off-the-shelf framework may be less useful than a menu of evidence-based resources which stakeholders can use to co-design their own frameworks.

How will Brexit affect health services in the UK? An updated evaluation.

All forms of Brexit are bad for health, but some are worse than others. This paper builds on our 2017 analysis using the WHO health system building blocks framework to assess the likely effects of Brexit on the National Health Service (NHS) in the UK. We consider four possible scenarios as follows: a No-Deal Brexit under which the UK leaves the EU on March 29, 2019, without any formal agreement on the terms of withdrawal; a Withdrawal Agreement, as negotiated between the UK and EU and awaiting (possible) formal agreement, which provides a transition period until the end of December, 2020; the Northern Ireland Protocol's backstop coming into effect after the end of that period; or the Political Declaration on the Future Relationship between the UK and EU. Our analysis shows that a No-Deal Brexit is substantially worse for the NHS than a future involving the Withdrawal Agreement, which provides certainty and continuity in legal relations while the Political Declaration on the Future Relationship is negotiated and put into legal form. The Northern Ireland backstop has varying effects, with continuity in some areas, such as health products, but no continuity in others. The Political Declaration on the Future Relationship envisages a relationship that is centred around a free-trade agreement, in which wider health-related issues are largely absent. All forms of Brexit, however, involve negative consequences for the UK's leadership and governance of health, in both Europe and globally, with questions about the ability of parliament and other stakeholders to scrutinise and oversee government actions.

Everything you always wanted to know about European Union health policies but were afraid to ask

What does the European Union (EU) mean for health? What can it mean for health? This comprehensively revised second edition answers these questions. It provides a broad review and analysis of EU public health policies to mid-2019. It begins by explaining the basic politics of European integration and European policy-making in health, including the basic question of how the EU came to have a health policy and what that policy does. Thereafter, it moves on to the three faces of EU health policy. The first face is explicit health policy, both public health policy and policies to strengthen health services and systems in areas such as cancer, and communicable diseases. The second face is internal market building policies, which are often more consequential for health services, but are not made with health as a core objective. These include professional and patient mobility, regulation of insurers and health care providers, and competition in health care. They also include some of the policies through which the EU has had dramatic and positive health effects, namely environmental regulation, consumer protection and labour law. The third face is fiscal governance, in which the EU institutions police member state decisions, including relating to health. Each face has different politics, law, policy and health effects. The book provides a synthesis of the different faces and the different ways in which they have been used to strengthen or weaken public health and health systems in Europe. It shows the many, often unappreciated, ways that the EU has worked for health, as well as the opportunities to further strengthen the EU's positive impact on health. This book is aimed at policy-makers and students of health systems in the EU who seek to understand how the influence of the EU on health policy affects those systems and their patients. To ensure that the EU’s impact on health is wholly positive, the wider health community must understand and engage with the EU in the future – something this book aims to encourage.