Public Involvement and Engagement in Big Data Research: Scoping Review.

BACKGROUND: The success of big data initiatives depends on public support. Public involvement and engagement could be a way of establishing public support for big data research. OBJECTIVE: This review aims to synthesize the evidence on public involvement and engagement in big data research. METHODS: This scoping review mapped the current evidence on public involvement and engagement activities in big data research. We searched 5 electronic databases, followed by additional manual searches of Google Scholar and gray literature. In total, 2 public contributors were involved at all stages of the review. RESULTS: A total of 53 papers were included in the scoping review. The review showed the ways in which the public could be involved and engaged in big data research. The papers discussed a broad range of involvement activities, who could be involved or engaged, and the importance of the context in which public involvement and engagement occur. The findings show how public involvement, engagement, and consultation could be delivered in big data research. Furthermore, the review provides examples of potential outcomes that were produced by involving and engaging the public in big data research. CONCLUSIONS: This review provides an overview of the current evidence on public involvement and engagement in big data research. While the evidence is mostly derived from discussion papers, it is still valuable in illustrating how public involvement and engagement in big data research can be implemented and what outcomes they may yield. Further research and evaluation of public involvement and engagement in big data research are needed to better understand how to effectively involve and engage the public in big data research. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-https://doi.org/10.1136/bmjopen-2021-050167.

Donor conception, direct-to-consumer genetic testing, choices, and procedural justice: an argument for reform of the Human Fertilisation and Embryology Act 1990.

In this article, using theories of procedural justice and 'slow violence', we consider potential reform of the Human Fertilisation and Embryology Act 1990. Our theoretical discussion is underpinned by findings from the ConnecteDNA project, exploring how people affected by donor conception experience direct-to-consumer genetic testing (DTCGT). The negative impacts of DTCGT, especially shock discoveries about the circumstances of someone's conception in adulthood, are linked to donor anonymity, and how its continued protection is experienced as a barrier to the rights and agency of donor-conceived people. We focus on two key issues relating to the donor information access process set out in section 31ZA of the 1990 Act. The first is that it excludes certain cohorts of donor-conceived people, creating inequalities of access to donor information. The second is the impact of the use of DTCGT to search for that information. We discuss what a procedurally just process of law reform would look like, concluding that, whatever (prospective) approach to donor anonymity is taken, the donor information access process should be the same for all donor-conceived people. We thus argue that, even were the status quo to be maintained, reform of the donor information access process with retrospective effect would be required.

Using symbiotic empirical ethics to explore the significance of relationships to clinical ethics: findings from the Reset Ethics research project.

BACKGROUND: At the beginning of the coronavirus (Covid-19) pandemic, many non-Covid healthcare services were suspended. In April 2020, the Department of Health in England mandated that non-Covid services should resume, alongside the continuing pandemic response. This 'resetting' of healthcare services created a unique context in which it became critical to consider how ethical considerations did (and should) underpin decisions about integrating infection control measures into routine healthcare practices. We draw on data collected as part of the 'NHS Reset Ethics' project, which explored the everyday ethical challenges of resetting England's NHS maternity and paediatrics services during the pandemic. METHODS: Healthcare professionals and members of the public participated in interviews and focus group discussions. The qualitative methods are reported in detail elsewhere. The focus of this article is our use of Frith's symbiotic empirical ethics methodology to work from our empirical findings towards the normative suggestion that clinical ethics should explicitly attend to the importance of relationships in clinical practice. This methodology uses a five-step approach to refine and develop ethical theory based on a naturalist account of ethics that sees practice and theory as symbiotically related. RESULTS: The Reset project data showed that changed working practices caused ethical challenges for healthcare professionals, and that infection prevention and control measures represented harmful barriers to the experience of receiving and offering care. For healthcare professionals, offering care as part of a relational interaction was an ethically important dimension of healthcare delivery. CONCLUSIONS: Our findings suggest that foregrounding the importance of relationships across a hospital community will better promote the ethically important multi-directional expression of caring between healthcare professionals, patients, and their families. We offer two suggestions for making progress towards such a relational approach. First, that there is a change of emphasis in clinical ethics practice to explicitly acknowledge the importance of the relationships (including with their healthcare team) within which the patient is held. Second, that organisational decision-making should take into account the moral significance afforded to caring relationships by healthcare professionals, and the role such relationships can play in the negotiation of ethical challenges.

Delivering compassionate NHS healthcare: A qualitative study exploring the ethical implications of resetting NHS maternity and paediatric services following the acute phase of the COVID-19 pandemic.

A distinction can be drawn between healthcare, where compassion is evident, and the functional delivery of health services. Measures to curb the spread of COVID-19, such as personal protective equipment, telehealth, and visiting restrictions created barriers to service delivery and put pressure on healthcare. Through 37 qualitative interviews with NHS senior managers (n = 11), health professionals (n = 26), and 5 focus group discussions with members of the public (n = 26), we explored experiences of the everyday ethical tensions created as services were being re-established following the acute phase of the COVID-19 pandemic in England. Our analysis enriches an understanding of compassionate care as outlined in NHS operational documents - covering the emotional, moral, and relational components of healthcare beyond the functionalities of treatment. From this analysis, we consider the normative standards underpinning NHS healthcare, concluding that, wherever possible, offering compassionate healthcare to patients and their families should be facilitated, and health professionals should themselves be compassionately supported in the workplace. Our findings foreground the need to consider the consequences of the short-term adoption of a functional treatment approach, including strategies that support health professionals and inform the public, to avoid the long-term damage caused by the fracturing of compassionate healthcare.

Understanding the extent of and limitations to conscientious objection to abortion by health care practitioners: A hermeneutic study.

The United Kingdom's Abortion Act 1967 has attracted substantial controversy, which has centred not only on the regulation of abortion itself, but also on the extent to which conscientious objection should be permitted. The aim of this study was to examine a range of healthcare professionals' views on conscientious objection and identify the appropriate parameters of conscientious objection to abortion. Gadamer's hermeneutic was utilised to frame this study. We conducted semi-structured interviews in two UK locations with 18 pharmacists, 17 midwives, 12 nurses and nine doctors, encompassing a mix of conscientious objectors and non-objectors to abortion. A multi-faceted in-depth data analysis led to the development of a hermeneutic of "respecting self and others". Four major themes of "doing the job", "entrusting to others", "acknowledging institutional power" and "being selective" and 18 subthemes contributed to this overarching theme. The complexity of the responses indicates that there is little consistency within and between each profession. They show that participants who were conscientious objectors were accepted by their colleagues and accommodated without detriment to the service, and that in larger hospitals, such as those where our work was carried out, it is possible to be employed in the service areas that include abortion while still being a conscientious objector. Finally, our results indicate that, by respecting of self and others, each profession should be able to accommodate conscience-based objections where individual practitioners seek to exercise them. Conscientious objectors as well as non-objectors have something to contribute to the ongoing development of the maternity and gynaecological services as abortion is only a small part of the work of these services.

Developing translational bioethics-Suggestions for ways forward.

This paper will take as its starting point the premise that developing translational bioethics is a worthwhile endeavour. I will develop an account of translational bioethics and discuss what implications this would have for the wider discipline of bioethics and argue that this would be a useful development for bioethics. The paper will conduct a form of 'translational meta-bioethics analysis', in the words of Baerøe. I will argue that if we are serious about instituting translational bioethics, then it will need to look and be organised in a very different way from current bioethics research, this will be a radically different form of bioethics from what we currently have. In this paper I will sketch what translational bioethics might look like. My proposal here is not that translational bioethics should supplant existing ways of doing bioethics, but rather that it should be an addition to it, another subdiscipline of bioethics.

Direct-to-consumer genetic testing and the changing landscape of gamete donor conception: key issues for practitioners and stakeholders.

RESEARCH QUESTION: What effect does direct-to-consumer genetic testing (DTCGT) have on information finding and sharing in relation to gamete donor conception? DESIGN: This study used in-depth qualitative interviews with parents through donor conception, donors, the relatives of donors and donor-conceived people who have used, or considered using, DTCGT. Interviews were conducted between September 2021 and February 2023. Sixty people defined themselves as having been affected by donor conception and DTCGT. Fifty-seven of these were resident in the UK at the time of interview. The final sample included 19 (spermatozoa, egg or embryo) donors, 25 donor-conceived people, 20 parents through donor conception and two relatives of donors. Five participants occupied more than one of these roles. RESULTS: The rise of DTCGT is affecting how information about donor conception is managed: it shifts patterns of knowledge about donor conception; increases flexibility regarding the age of access to information about donor relatives; can lead to a growing role for non-professionals, including wider family members, in gatekeeping information about donor conception; accentuates the effect of donor conception for donors' and the relatives of donor-conceived people; and shapes, and is shaped, by the formal regulatory donor information management systems. CONCLUSION: Fertility professionals should inform people using, or considering, donor conception, or (potential) donors, about the different ways DTCGT can affect sharing information about donor conception. Support is needed for those affected by these changes.

Exploring how to improve the involvement of Polish and South Asian communities around big data research. A qualitative study using COM-B model.

Introduction: Involving public contributors helps researchers to ensure that public views are taken into consideration when designing and planning research, so that it is person-centred and relevant to the public. This paper will consider public involvement in big data research. Inclusion of different communities is needed to ensure everyone's voice is heard. However, there remains limited evidence on how to improve the involvement of seldom-heard communities in big data research. Objectives: This study aims to understand how South Asians and Polish communities in the UK can be encouraged to participate in public involvement initiatives in big data research. Methods: Forty interviews were conducted with Polish (n=20) and South Asian (n=20) participants on Zoom. The participants were living in the United Kingdom and had not previously been involved as public contributors. Transcribed interviews were analysed using reflexive thematic analysis. Results: We identified eight themes. The 'happy to reuse data' theme sets the scene by exploring our participants' views towards big data research and under what circumstances they thought that data could be used. The remaining themes were mapped under the capability-opportunity-motivation-behaviour (COM-B) model, as developed by Michie and colleagues. This allowed us to discuss multiple factors that could influence people's willingness to become public contributors. Conclusions: Our study is the first to explore how to improve the involvement and engagement of seldom-heard communities in big data research using the COM-B model. The results have the potential to support researchers who want to identify what can influence members of the public to be involved. By using the COM-B model, it is possible to determine what measures could be implemented to better engage these communities.

Developing a combined framework for priority setting in integrated health and social care systems.

BACKGROUND: There is an international move towards greater integration of health and social care to cope with the increasing demand on services.. In Scotland, legislation was passed in 2014 to integrate adult health and social care services resulting in the formation of 31 Health and Social Care Partnerships (HSCPs). Greater integration does not eliminate resource scarcity and the requirement to make (resource) allocation decisions to meet the needs of local populations. There are different perspectives on how to facilitate and improve priority setting in health and social care organisations with limited resources, but structured processes at the local level are still not widely implemented. This paper reports on work with new HSCPs in Scotland to develop a combined multi-disciplinary priority setting and resource allocation framework. METHODS: To develop the combined framework, a scoping review of the literature was conducted to determine the key principles and approaches to priority setting from economics, decision-analysis, ethics and law, and attempts to combine such approaches. Co-production of the combined framework involved a multi-disciplinary workshop including local, and national-level stakeholders and academics to discuss and gather their views. RESULTS: The key findings from the literature review and the stakeholder workshop were taken to produce a final combined framework for priority setting and resource allocation. This is underpinned by principles from economics (opportunity cost), decision science (good decisions), ethics (justice) and law (fair procedures). It outlines key stages in the priority setting process, including: framing the question, looking at current use of resources, defining options and criteria, evaluating options and criteria, and reviewing each stage. Each of these has further sub-stages and includes a focus on how the combined framework interacts with the consultation and involvement of patients, public and the wider staff. CONCLUSIONS: The integration agenda for health and social care is an opportunity to develop and implement a combined framework for setting priorities and allocating resources fairly to meet the needs of the population. A key aim of both integration and the combined framework is to facilitate the shifting of resources from acute services to the community.

Democratic Justifications for Patient Public Involvement and Engagement in Health Research: An Exploration of the Theoretical Debates and Practical Challenges.

The literature on patient public involvement and engagement (PPIE) in health research has grown significantly in the last decade, with a diverse range of definitions and topologies promulgated. This has led to disputes over what the central functions and purpose of PPIE in health research is, and this in turn makes it difficult to assess and evaluate PPIE in practice. This paper argues that the most important function of PPIE is the attempt to make health research more democratic. Bringing this function to the fore and locating PPIE in the wider context of changes in contemporary forms of democratic engagement provides greater conceptual clarity over what PPIE in research should be trying to achieve. Conceptualizing PPIE as a form of democratization has a number of benefits. First, theories of what are appropriate, normatively justifiable and workable criteria for PPIE practices can be developed, and this can provide tools to address the legitimacy and accountability questions that have troubled the PPIE community. Second, this work can be used to form the basis of a research agenda to investigate how PPIE in health research operates, and how it can facilitate and/or improve democratic processes in health research.

Extending the data collection from a clinical trial: The Extended Salford Lung Study research cohort.

The Extended Salford Lung Study (Ext-SLS) is an extension of the Salford Lung Studies (SLS) in asthma and chronic obstructive pulmonary disease (COPD) through retrospective and prospective collection of patient-level electronic health record (EHR) data. We compared the Ext-SLS cohort with the SLS intention-to-treat populations using descriptive analyses to determine if the strengths (e.g. randomization) of the clinical trial were maintained in the new cohort. Historical and patient-reported outcome data were captured from asthma-/COPD-specific questionnaires (e.g., Asthma Control Test [ACT]/COPD Assessment Test [CAT]). The Ext-SLS included 1147 participants (n = 798, SLS asthma; n = 349, SLS COPD). Of participants answering the ACT, 39% scored <20, suggesting poorly controlled asthma. For COPD, 61% of participants answering the CAT scored ≥21, demonstrating a high disease burden. Demographic/clinical characteristics of the cohorts were similar at SLS baseline. EHR data provided a long-term view of participants' disease, and questionnaires provided information not typically captured. The Ext-SLS cohort is a valuable resource for respiratory research, and ongoing prospective data collection will add further value and ensure the Ext-SLS is an important source of patient-level information on obstructive airways disease.

'To me, it's ones and zeros, but in reality that one is death': A qualitative study exploring researchers' experience of involving and engaging seldom-heard communities in big data research.

BACKGROUND: Big data research requires public support. It has been argued that this can be achieved by public involvement and engagement to ensure that public views are at the centre of research projects. Researchers should aim to include diverse communities, including seldom-heard voices, to ensure that a range of voices are heard and that research is meaningful to them. OBJECTIVE: We explored how researchers involve and engage seldom-heard communities around big data research. METHODS: This is a qualitative study. Researchers who had experience of involving or engaging seldom-heard communities in big data research were recruited. They were based in England (n = 5), Scotland (n = 4), Belgium (n = 2) and Canada (n = 1). Twelve semistructured interviews were conducted on Zoom. All interviews were audio-recorded and transcribed, and we used reflexive thematic analysis to analyse participants' experiences. RESULTS: The analysis highlighted the complexity of involving and engaging seldom-heard communities around big data research. Four themes were developed to represent participants' experiences: (1) abstraction and complexity of big data, (2) one size does not fit all, (3) working in partnership and (4) empowering the public contribution. CONCLUSION: The study offers researchers a better understanding of how to involve and engage seldom-heard communities in a meaningful way around big data research. There is no one right approach, with involvement and engagement activities required to be project-specific and dependent on the public contributors, researchers' needs, resources and time available. PATIENT AND PUBLIC INVOLVEMENT: Two public contributors are authors of the paper and they were involved in the study design, analysis and writing.

RELATIONSHIPS, RIGHTS, AND RESPONSIBILITIES: (RE)VIEWING THE NHS CONSTITUTION FOR THE POST-PANDEMIC 'NEW NORMAL'.

Action needs to be taken to map out the fairest way to meet the needs of all NHS stakeholders in the post-pandemic 'new normal'. In this article, we review the NHS Constitution, looking at it from a relational perspective and suggesting that it offers a useful starting point for such a project, but that new ways of thinking are required to accommodate the significant changes the pandemic has made to the fabric of the NHS. These new ways of thinking should encompass concepts of solidarity, care, and (reciprocal) responsibility, grounded in an acceptance of the importance of relationships in society. To this end, we explore and emphasise the importance of our interconnections as NHS stakeholders and 're-view' the NHS Constitution from a relational perspective, concentrating on the rights and responsibilities it describes for patients and the public as NHS stakeholders. We argue that the NHS Constitution, of which most stakeholders are probably unaware, can be used as a tool to engage us, and to catalyse conversation about how our responsibilities as NHS stakeholders should change in the post-pandemic 'new normal'.

Public contributors' preferences for the organization of remote public involvement meetings in health and social care: A discrete choice experiment study.

INTRODUCTION: Covid-19 expanded the use of remote working to engage with public contributors in health and social care research. These changes have the potential to limit the ability to participate in patient and public involvement and engagement (PPIE) for some public contributors. It is therefore important to understand public contributors' preferences, so that remote working can be organized in an optimal way to encourage rather than discourage participation. METHODS: We use an economic preference elicitation tool, a discrete choice experiment (DCE), via an online survey, to estimate public contributors' preferences for and trade-offs between different features of remote meetings. The features were informed by previous research to include aspects of remote meetings that were relevant to public contributors and amenable to change by PPIE organizers. RESULTS: We found that public contributors are more likely to participate in a PPIE project involving remote meetings if they are given feedback about participation; allowed to switch their camera off during meetings and step away if/when needed; were under 2.5 h long; organized during working hours, and are chaired by a moderator who can ensure that everyone contributes. Different combinations of these features can cause estimated project participation to range from 23% to 94%. When planning PPIE and engaging public contributors, we suggest that resources are focused on training moderators and ensuring public contributors receive meeting feedback. DISCUSSION AND CONCLUSION: Project resources should be allocated to maximize project participation. We provide recommendations for those who work in public involvement and organize meetings on how resources, such as time and financial support, should be allocated. These are based on the preferences of existing public contributors who have been involved in health and social care research. PATIENT OR PUBLIC CONTRIBUTION: We had a public contributor (Naheed Tahir) as a funded coapplicant on the UKRI ESRC application and involved members of the North West Coast Applied Research Collaboration (NWC ARC) Public Advisor Forum at every stage of the project. The survey design was informed from three focus groups held with NWC ARC public contributors. The survey was further edited and improved based on the results of six one-to-one meetings with public contributors.

Artificial intelligence and health inequities in primary care: a systematic scoping review and framework.

OBJECTIVE: Artificial intelligence (AI) will have a significant impact on healthcare over the coming decade. At the same time, health inequity remains one of the biggest challenges. Primary care is both a driver and a mitigator of health inequities and with AI gaining traction in primary care, there is a need for a holistic understanding of how AI affect health inequities, through the act of providing care and through potential system effects. This paper presents a systematic scoping review of the ways AI implementation in primary care may impact health inequity. DESIGN: Following a systematic scoping review approach, we searched for literature related to AI, health inequity, and implementation challenges of AI in primary care. In addition, articles from primary exploratory searches were added, and through reference screening.The results were thematically summarised and used to produce both a narrative and conceptual model for the mechanisms by which social determinants of health and AI in primary care could interact to either improve or worsen health inequities.Two public advisors were involved in the review process. ELIGIBILITY CRITERIA: Peer-reviewed publications and grey literature in English and Scandinavian languages. INFORMATION SOURCES: PubMed, SCOPUS and JSTOR. RESULTS: A total of 1529 publications were identified, of which 86 met the inclusion criteria. The findings were summarised under six different domains, covering both positive and negative effects: (1) access, (2) trust, (3) dehumanisation, (4) agency for self-care, (5) algorithmic bias and (6) external effects. The five first domains cover aspects of the interface between the patient and the primary care system, while the last domain covers care system-wide and societal effects of AI in primary care. A graphical model has been produced to illustrate this. Community involvement throughout the whole process of designing and implementing of AI in primary care was a common suggestion to mitigate the potential negative effects of AI. CONCLUSION: AI has the potential to affect health inequities through a multitude of ways, both directly in the patient consultation and through transformative system effects. This review summarises these effects from a system tive and provides a base for future research into responsible implementation.

Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study.

OBJECTIVES: Obtaining informed consent from patients in intensive care units (ICUs) prior to enrolment in a study is practically and ethically complex. Decisions about the participation of critically ill patients in research often involve substitute decision makers (SDMs), such as a patient's relatives or doctors. We explored the perspectives of different stakeholder groups towards these consent procedures. DESIGN AND METHODS: Mixed-methods study comprising surveys completed by ICU patients, their relatives and healthcare practitioners in 14 English ICUs, followed by qualitative interviews with a subset of survey participants. Empirical bioethics informed the analysis and synthesis of the data. Survey data were analysed using descriptive statistics of Likert responses, and analysis of interview data was informed by thematic reflective approaches. RESULTS: Analysis included 1409 survey responses (ICU patients n=333, relatives n=488, healthcare practitioners n=588) and 60 interviews (ICU patients n=13, relatives n=30, healthcare practitioners n=17). Most agreed with relatives acting as SDMs based on the perception that relatives often know the patient well enough to reflect their views. While the practice of doctors serving as SDMs was supported by most survey respondents, a quarter (25%) disagreed. Views were more positive at interview and shifted markedly depending on particularities of the study. Participants also wanted reassurance that patient care was prioritised over research recruitment. Findings lend support for adaptations to consent procedures, including collaborative decision-making to correct misunderstandings of the implications of research for that patient. This empirical evidence is used to develop good practice guidance that is to be published separately. CONCLUSIONS: Participants largely supported existing consent procedures, but their perspectives on these consent procedures depended on their perceptions of what the research involved and the safeguards in place. Findings point to the importance of explaining clearly what safeguards are in place to protect the patient.