Involving carer advisors in evidence synthesis to improve carers' mental health during end-of-life home care: co-production during COVID-19 remote working

Article history

The contractual start date for this research was in July 2019. This article began editorial review in June 2022 and was accepted for publication in February 2023. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The Health and Social Care Delivery Research editors and publisher have tried to ensure the accuracy of the authors’ article and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this article.

Copyright statement

Copyright © 2023 Grande et al. This work was produced by Grande et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

2023 Grande et al.

Creating a carer Review Advisory Panel

The project included a carer co-applicant (JF) to ensure PPI in project design from the outset. JF had PPI experience as an advisor on the Public and Community Involvement and Engagement (PCIE) Panel of the NIHR Applied Research Collaboration Greater Manchester (ARC GM). Co-applicants highlighted the need for a carer RAP within the design to ensure the carer voice was a central part of the project. 5,14 This would facilitate carers being involved in all stages of the project, including having input into the search terms to identify relevant literature, analysing the qualitative data, ensuring that interpretation and synthesis of findings remained grounded in carers’ experience and concerns, and ensuring that dissemination materials were understandable and meaningful from the carers’ perspective.

The recruitment process aimed to ensure potential RAP members had a clear understanding of what they were being invited to do. 1,6 Plain English recruitment adverts and further information for carers interested in becoming involved were developed with JF and another carer on the PCIE Panel of ARC GM. These covered project aims, the role of the RAP and how it would work, and who could apply and how. Detailed documents were also provided on terms of reference, including RAP member role description, and payment policy.

Both open and targeted recruitment strategies were employed5 to ensure wide reach. The project was advertised widely through Twitter with links to project webpage information. Further, local carer support groups were identified and were e-mailed flyers and further information. In a second recruitment drive, KB followed up with additional e-mails and phone calls, and located and contacted additional relevant groups. Finally, potential candidates known to JF were contacted directly. 1,5

To help ascertain eligibility and ensure equitable access and diversity in the composition of the RAP, all candidates completed a brief application form, through e-mail, paper document or online survey. The project aimed to recruit six RAP members who varied in terms of age, sex, ethnicity, experiences of caring for patients with different conditions, and experience of PPI. 1 A selection process protocol was set up to shortlist applicants and conduct interviews to identify the final RAP membership. However, as there was only a small number of applicants (eight), KB conducted informal telephone conversations with all to check their understanding of the project and ability to commit to regular meetings, and to gain information on their demographics, background of caring and PPI. This information was anonymised, tabulated and mapped to the recruitment criteria to identify the candidates who represented the widest range of carer experiences; for example, five of the candidates were men, of whom three were selected to ensure gender balance. The resulting group had balanced numbers of males and females, ethnic minority community representation, and included carers of people with cancer or non-cancer diagnoses, with long-term or shorter-term experience of caregiving, and ranging from extensive PPI experience to none.

Pre-RAP preparation and relationship-building was facilitated by KB and TS through individual face-to-face meetings with the selected RAP members to explain what was required of the role in more detail1,5,14 and give carers an opportunity to tell their story. This proved extremely beneficial in building researcher–carer relationships, so carers felt comfortable and able to contribute when attending their first RAP meeting. Unfortunately, the carer from the ethnic minority community stepped back before the first RAP meeting due to personal circumstances, leaving a total of five RAP members. A second carer stepped back towards the end of the project, as the role evolved to be more demanding, but was still able to make a substantial contribution.

Meeting principles, formats and processes

The RAP met nine times in total. Table 1 provides an outline of the meetings and their content.

Below we outline the principles that guided the meetings (see Box 1 for summary).

Ongoing meeting principles

To ensure carer voices were heard and valued, the project focused on the composition and chairing of the RAP meetings and on providing space to follow the carers’ agenda. It also followed recommended principles for appropriate payment, training, preparation and communication. 1,5

Review Advisory Panel involvement as planned

The RAP made the following contributions set out in the original project aims: reviewing the search strategy; contributing to qualitative review analysis; reviewing findings and helping shape the presentation of findings; considering how findings may fit together within a comprehensive framework; supporting the stage 2 stakeholder consultation; and reviewing final project products (dissemination materials and reporting). Some further details are outlined below.

Importantly, the RAP ensured the content of the synthesis was meaningful. They were central in ensuring that the qualitative literature synthesis identified factors associated with carer mental health and grouped them into themes that were meaningful from carers’ perspective. 9 The main themes were ‘patient condition’, ‘impact of caring responsibilities’, ‘finances’, ‘relationships’, ‘carer internal processes’ and ‘support’. Findings from the subsequent quantitative observational and intervention syntheses were then mapped onto these themes (with an added theme of ‘contextual factors’). The RAP reviewed whether the subthemes to these main themes made sense to carers and whether anything was missing. One clear gap identified by the RAP was the lack of consideration of the impact of financial factors on carer well-being within the quantitative literature. 10 Additional missing components were: identifying as a ‘carer’, loss of own identity and limited consideration of ethnicity. Further, while the quantitative literature labelled some coping strategies as ‘dysfunctional’ or maladaptive, RAP members considered these as potentially helpful strategies in some circumstances, in the moment and in the context of an individual’s caregiving situation. Rather than labelling coping strategies as ‘dysfunctional’ or ‘functional’, it was felt that these should be judgement-free and simply presented as coping strategies found to be associated with ‘better’, ‘worse’ or ‘no change’ to carer mental health within the literature. 10

The RAP also advised on the presentation format of the findings. This included presentation of numerical data using colour-coded columns to highlight the number of investigations showing that a factor was associated with worse carer mental health (red) or better carer mental health (green), or showed no association (neutral colour). 10 Further, RAP members advised on how the total body of evidence could be organised into different levels of detail to enable stakeholders to first gain an overview of findings and then find the detailed content relevant to them (further detail will be reported elsewhere).

Finally, the RAP contributed to stage 2, where ‘products’ from syntheses were presented to other stakeholders (additional carers, patients, practitioners, commissioners, policy-makers) for feedback. The RAP advised on how to involve additional carers. Further, five RAP members, including the Chair, wanted to be involved in the stage 2 workshops and discussion groups, either as active participants or as observers. Four participated in the four online workshops with carers, practitioners and commissioners/policy-makers as participant (the Chair) or observers, and four RAP members each participated in one of two online discussion groups with GPs and carers. Further details about the stage 2 consultation and products will be reported elsewhere (https://www.arc-gm.nihr.ac.uk/carer-project-). Three RAP members agreed to feed back on the qualitative synthesis report,9 and all members contributed to the current paper through participation in reflection on their RAP involvement and paper review.

Changes to the project plan

The ‘space to talk’ within the project introduced perspectives beyond the original plan which were then accommodated through ‘space to change’. 3 This led to greater RAP involvement in the qualitative review analysis, using a simplified framework to organise findings, and most importantly, the addition of carer recommendations to the project ‘products’.

The RAP’s wish to be involved in the analysis and to develop recommendations expanded the number of meetings from the planned six meetings to nine in total. The added resources required to cover additional RAP hours and project time were aided by cost savings in moving from face-to-face to online activities. We outline project changes further below.

Method

Feedback was collected from RAP members and researchers via e-mail, using open-ended questions and written responses. Box 3 shows the questions asked. These were distributed to all RAP members and Core Research Team (CRT) members. Respondents were: all final RAP members, including the Chair (n = 5); CRT members who worked directly with the RAP (n = 4/5); and CRT members not directly involved with the RAP (n = 2/4). In the findings reported below, each respondent is allocated the ID codes RAP1–5, CRT1–4 and CRT 5–6, respectively.

KB and GG initially reviewed the collated materials from RAP and researcher respondents. Based on this, it was agreed that the material could broadly be organised into a framework of what made PPI work well or not so well. GG then worked through materials, writing freehand notes on the contents and then considered how the contents fitted the framework. Comments were next indexed according to the broad themes of what made the RAP involvement work and what were challenges. All materials relevant to a theme were collated for further in-depth scrutiny of any subthemes and how carer and researcher views compared or contrasted. The comments and resulting themes were reviewed in full by CR, and revisions made. Finally, all researchers and RAP members who had commented reviewed the resulting draft document to assess whether this had captured their perspectives. Thereafter, some further RAP feedback was incorporated in the final text and final adjustments made to subthemes.

Findings

Principles

The project ensured it created a strong, viable carer RAP whose perspectives could be properly expressed: firstly, by investing considerable time on recruitment processes to ensure an eligible, diverse and balanced group;1,5,14 secondly, through the composition of RAP meetings, with carers in the majority for mutual support; and thirdly, through a Chair who combined carer and chairing experience, providing both an understanding of the carer perspective and the confidence to bring it to the fore, while nurturing ‘novice’ PPI members. Being an ‘expert PPI member’ also helped the Chair facilitate bridging of researcher and carer perspectives.

Further, the project signalled the value placed on PPI from the outset: firstly, through prompt and appropriate payment,1,3 which demonstrated the tangible value ascribed to PPI (RAP feedback noted this as important); secondly, through strong and senior researcher representation at RAP meetings; and finally, by facilitating responsiveness to RAP input by providing ‘space to talk’ outside the agenda structure, and ‘space to change’,1,5 which led to substantial project changes. Additional principles of ongoing training, proper preparation and ongoing communication1,6,14 further ensured the RAP could contribute actively.

This enabled meaningful PPI and movement from mere consultation to the co-production of RAP carer recommendations based on findings (see Table 2). These were presented to the broader stakeholder groups in stage 2 alongside evidence synthesis findings, and perceived to be valuable in their own right (stage 2 will be reported in a future report).

Joint researcher and carer reflection indicated components underpinning this successful PPI. Firstly, there was a shared sense of the purpose and gains from RAP involvement. This may have been facilitated by individual pre-project meetings and ‘foundations’ laid in meeting 1. Secondly, there was mutual commitment and respect, possibly facilitated by early signalling of how carers were valued, clarification of project aims, and agreement of how to work together. Finally, there was meaningful bridging between academic and lay perspectives, based on sound principles of training and preparation, creation of a sense of equal partnership, and willingness by both parties to negotiate and compromise. Remote working enforced by COVID was perceived to hamper meeting communication, but there was sufficient resilience in the carer–researcher collaboration to overcome this.

The project applied principles drawn from existing literature. 1,3,5–7,14,15 Additionally, it carefully considered participant composition at meetings and use of the Chair to foster meaningful involvement, which has been given less attention, although Buck et al. 14 recommended using larger PPI groups, rather than single members. We cannot know to what extent successful project PPI was down to principles employed, as opposed to the characteristics of the participants (researchers and carers). However, it may be telling that the PPI input on the RMG worked less well, where some of the same participants were involved (Chair and research team), but there was less preparation and prior definition of roles and only one PPI member. Nevertheless, it is not a given that success would follow from mechanistic application of PPI principles in the absence of positive, constructive attitudes and a willingness to compromise and change. Knowles et al. 3 concluded that relational openness was more important to build trust for successful PPI than any particular methods used. However, the above principles are probably an important bedrock on which such openness and trust can be built.

Hybrid working

Our project indicates that meaningful co-production can be achieved through a hybrid between face-to-face and remote working. COVID provided an enforced ‘opportunity’ to test how project PPI could be maintained through online video meetings. Virtual meetings led to reduction in informality, flexibility, personal connection and non-verbal communication, compared to face-to-face communication. However, early face-to-face groundwork, including relationship-building, agreement of how to work together and understanding of each other’s roles, appeared to enable productive collaboration to continue remotely.

Online working also made meetings logistically easier to arrange and to attend, particularly for those more geographically distant (although the meeting preparation required from researchers and carers may actually have increased). This may have facilitated the consistently solid attendance across meetings. Research indicates that remote working increases inclusiveness in terms of geography,7,19 and also race, ethnicity, education, income,19 and accessibility for those affected by ill health or caregiving. 20 Previously, remote working may often have been limited to electronic communication through online forums20 or e-mail,7 with tele- and videoconferencing being relatively costly, limiting opportunity for dynamic interaction. However, online virtual meetings have now become a more viable, less costly option through greater access to online video meeting platforms, laptops and mobiles. While face-to-face working is still preferred7,14 and probably necessary for relationship-building, further research is warranted on how and when remote working provides a viable alternative.

Resourcing meaningful patient and public involvement

Adequate resources need to be built into PPI budgets from the outset to achieve meaningful PPI. 2,5 This includes proper investment in recruitment and participant preparation2 and ample time and resources for meetings to permit dynamic interaction and collaboration. In particular, allowing for ‘space to talk’ and ‘space to change’3 to achieve genuine co-production has resource implications. Accommodating change in our project not only required researchers’ willingness to be flexible and make adaptations and RAP members’ willingness to take on extra work and involvement, it also required proper resourcing: first, to enable payment for additional RAP hours to accommodate changes, and second, to allow extended and protected project time for researchers to facilitate communication and develop or adapt materials. Here, COVID in fact helped facilitate more ‘space’ to make changes, as the time and costs saved by moving to virtual meetings (on travel, venues, catering) provided more flexibility to incorporate required adaptations. However, projects cannot generally rely on such serendipity. The ability to work iteratively and make changes in response to PPI input is central to co-production. Such flexibility therefore needs to be built into projects. However, structures of academic funding can currently make this difficult,3 and more flexible funding models for PPI may need to be considered.

Going forward, future projects must budget properly for PPI participants’ time and ability to participate to allow meaningful engagement. This includes time for preparation, travel, meeting hours and review, and reimbursement for travel, subsistence and/or internet connectivity. However, a major PPI cost that may be overlooked in budgets is adequate researcher time for PPI in the project schedule, including time for proper meeting preparation (including procedures, documents and training), responding to meeting feedback (including production of new/amended project materials, procedures and schedules), and ongoing communication and engagement (including gaining PPI review and feedback for amendments). Preparing for PPI (before PPI engagement formally commences) is also resource-intensive, but proved crucial to our project. However, this may pose a dilemma, as it should ideally take place before the start of the project proper, at which point funding may not be available. For example, we adopted a broad carer RAP recruitment strategy before project start, but it yielded few candidates, and would probably have been more effective had there been more resources for this; for example, to speak to carer group leads and present to group members. For longer-term longitudinal projects, it would also be beneficial to recruit and cost for a larger PPI group, to allow for potential dropout along the way. Additionally, building in ‘space to change’ would require PPI budgets that are realistic about costs, but where there is flexibility regarding details of how money should be spent, with allowance for viring between budget headings. Finally, meaningful PPI engagement for funded projects may be further aided by easier access to flexible PPI funds for preparing PPI before project start or accommodating unexpected, added work arising out of PPI feedback.

Limitations

A strength was the joint reflection of both researchers and carers on PPI in the project. However, it would have been beneficial to evaluate researcher and RAP experiences of PPI at each project stage rather than just at the end. This would have provided richer insights and enabled ongoing project improvements. However, the time and capacity for evaluation were limited within the tight timetable. The reflections from the RAP and researchers at the end of the project did provide some insight into their respective perspectives, but did not permit in-depth exploration. Further, this was a small set of respondents whose identities were known to analysts and could be guessed at by others. While group members (both RAP and researchers) were used to having open and frank discussion, this may still have made some respondents hold back on any negative feedback. The evaluation did not include a RAP member who stepped back towards the end of the project and who may also have had more mixed views of the experience. Finally, the analysis was conducted and written up by researchers who also had contributed responses, and reviewed by the group who had contributed responses as a whole. Although honest feedback and objective analysis was attempted, the conclusions may therefore be biased towards existing views. Researcher and RAP views therefore remain a piece of self-reflection, rather than an independent investigation.

Dissemination

Carer RAP recommendations and PPI work have been reported to stakeholder groups through project meetings, workshops and focus groups and will be disseminated via posters and leaflets, podcasts, webinars and the project website. Awareness of the findings will be raised via Twitter and through stakeholder networks of NIHR ARC GM and co-applicants. The current paper, reports for additional project components, and all project materials will be available through the project website https://www.arc-gm.nihr.ac.uk/carer-project-.

Equality, diversity and inclusion

Regarding the research itself, the evidence synthesis project ensured that carers’ own perspectives were highlighted from the synthesis by making the qualitative review of carers’ own experiences the central review, which then guided the synthesis of the quantitative reviews. Further, all reviews considered the ethnic composition of reviewed studies, and all reports presented any findings on ethnicity and noted the limited representation of ethnic minorities in the literature. The evidence synthesis was limited to Organisation for Economic Co-operation and Development (OECD) countries to enable comparison with countries whose health-care systems were likely to be comparable with the UK, and limited to publications in English and Scandinavian due to resource constraints, and this is noted as a limitation of the project. The work with the carer RAP and the stage 2 stakeholder consultation sought to ensure that project findings were presented in formats accessible to all carer groups and stakeholders.

Regarding the research team and other involvement, the project was shaped and guided by carers themselves, as described in this report. First, by having a carer co-applicant help develop the project; and second, by recruiting a strong and active carer RAP who helped shape the search strategy, conduct the analysis, interpret the results, and shape the presentation of project materials and dissemination, and whose carer recommendations became a key project outcome. Further, in the project’s stage 2 stakeholder consultation, carers constituted nearly one-third of the meeting participants. Although there was no ethnic minority representation within the co-applicant team, the project was initially able to bring on board a carer advisor from an ethnic minority community group who was involved in RAP pre-meeting preparations, but had to withdraw before the first full RAP meeting proper. However, in the project’s stage 2 stakeholder consultation one-tenth of the meeting participants were from ethnic minorities.

Contributions of authors

Gunn Grande (https://orcid.org/0000-0003-2200-1680) (Professor of Palliative Care, Chief Investigator, palliative care, carers, health psychology) developed the project protocol; provided support for the collaboration with the RAP and development of project materials; contributed to the reflections on PPI; analysed the reflections on PPI; drafted the manuscript; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Kerin Bayliss (https://orcid.org/0000-0002-9047-2516) (Research Associate, research staff, PPI and qualitative evidence synthesis) managed the collaboration with the RAP and developed project materials; contributed to the reflections on PPI; analysed the reflections on PPI; assisted with drafting the manuscript; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Tracey Shield (https://orcid.org/0000-0002-6747-613X) (Research Fellow, research staff, mixed-methods evidence synthesis) managed the collaboration with the RAP and developed project materials; assisted RAP members with producing the carer recommendations; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Jackie Flynn (PPI representative and RAP Chair, Co-applicant, caregiver experience and PPI) developed the project protocol; chaired the RAP; facilitated the collaboration between researchers and the RAP; contributed to the reflections on PPI, had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Christine Rowland (https://orcid.org/0000-0001-8628-4638) (Research Fellow, Co-applicant, health psychology and outcome measures) developed the project protocol; provided support for the collaboration with the RAP and development of project materials; contributed to the reflections on PPI; analysed the reflections on PPI; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Danielle Harris (https://orcid.org/0000-0002-3330-7346) (Research Assistant, research staff, PPI) provided support for the collaboration with the RAP and development of project materials; contributed to the reflections on PPI; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Alison Wearden (https://orcid.org/0000-0001-6074-6275) (Professor of Health Psychology, Co-applicant, health psychology and carers) developed the project protocol; reviewed and advised on the RAP collaboration; contributed to the reflections on PPI; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Morag Farquhar (https://orcid.org/0000-0001-7991-7679) (Professor of Palliative Care Research, Co-applicant, palliative care, carers and nursing) developed the project protocol; reviewed and advised on the RAP collaboration; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Maria Panagioti (https://orcid.org/0000-0002-7153-5745) (Senior Lecturer, Co-applicant, quantitative evidence synthesis, primary care, mental health) developed the project protocol; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Alexander Hodkinson (https://orcid.org/0000-0003-2063-0977) reviewed and advised on the RAP collaboration; contributed to the reflections on PPI; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Margaret Booth (carer RAP member, caregiver experience) helped with qualitative analysis; advised on project processes, findings and materials; helped shape the direction of the project and produced the carer recommendations; contributed to the reflections on PPI; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

David Cotterill (carer RAP member, caregiver experience) helped with qualitative analysis, advised on project processes, findings and materials; helped shape the direction of the project and produced the carer recommendations, contributed to the reflections on PPI; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Lesley Goodburn (carer RAP member, caregiver experience) helped with qualitative analysis; advised on project processes, findings and materials; helped shape the direction of the project and produced the carer recommendations; contributed to the reflections on PPI; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Cedric Knipe (carer RAP member, caregiver experience) helped with qualitative analysis; advised on project processes, findings and materials; helped shape the direction of the project and produced the carer recommendations; contributed to the reflections on PPI; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Penny Bee (https://orcid.org/0000-0002-5600-0400) (Professor of Applied Mental Health Research, Co-applicant, mental health, health services research) developed the project protocol; reviewed and advised on the RAP collaboration; had access to study data; reviewed the synthesis of project principles, outputs and reflections; provided critical revision of the manuscript for important intellectual content; and takes responsibility for data integrity and analysis.

Ethics statement/approval(s)

This is a report on the PPI in an evidence synthesis of existing literature and of the co-authors’ reflections on the process. All data reported were generated by the co-authors and reviewed and approved by them. Consultation with the University of Manchester Research Practice Governance Office established that the project did not require ethics approval.

Information governance

There were no personal data involved in the production of this report.

Data-sharing statement

For further data relating to this report and the project as a whole visit the project website https://www.arc-gm.nihr.ac.uk/carer-project-. For further information on PPI processes and materials please contact the corresponding author. Individual reflections are not available due to confidentiality.

Funding

This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (grant 18/01/01) and will be published in full in Health and Social Care Delivery Research. See the NIHR Journals Library website for further project information.

This article

The contractual start date for this research was in July 2019. This article began editorial review in June 2022 and was accepted for publication in February 2023. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The Health and Social Care Delivery Research editors and publisher have tried to ensure the accuracy of the authors’ article and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this article.

Disclaimer

The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.