Amy Mathieson

Direct-to-consumer (DTC) pharmacogenomic (PGx) testing is expanding rapidly in the UK, yet no dedicated regulatory framework currently governs these services. Although a 2021 parliamentary inquiry recommended stronger safeguards and clearer technical standards for genomic testing, these proposals have not been applied to PGx. This study explores public attitudes toward DTC PGx testing, focusing on expectations for pre-test information, quality standards, and NHS data use. We conducted focus groups with members of the public, both with and without prior experience of purchasing DTC PGx tests, or other online health tests. Focus groups were audio-recorded with consent, transcribed, and analysed thematically. We identified three themes: (mis)understanding towards and awareness of DTC PGx testing; altruistic motivation and equity concerns; and (mis)trust. Participants were generally enthusiastic about PGx testing, as long as issues of equity, data protection, and regulation were addressed, with data sharing concerns being particularly prominent.

Direct-to-consumer (DTC) pharmacogenomic (PGx) testing is expanding rapidly in the UK, yet no dedicated regulatory framework currently governs these services. Although a 2021 parliamentary inquiry recommended stronger safeguards and clearer technical standards for genomic testing, these proposals have not been applied to PGx. This study explores public attitudes toward DTC PGx testing, focusing on expectations for pre-test information, quality standards, and NHS data use. We conducted focus groups with members of the public, both with and without prior experience of purchasing DTC PGx tests, or other online health tests. Focus groups were audio-recorded with consent, transcribed, and analysed thematically. We identified three themes: (mis)understanding towards and awareness of DTC PGx testing; altruistic motivation and equity concerns; and (mis)trust. Participants were generally enthusiastic about PGx testing, as long as issues of equity, data protection, and regulation were addressed, with data sharing concerns being particularly prominent.

Background: Most implementation research focuses on understanding and changing health professionals’ work practices. While Patient and Public Involvement and Engagement (PPIE) in applied health research is recognised as best practice, and is often a requirement for funders globally, little is known about the role of patients and the public in implementation research. Methods: Guided by Arksey and O’Malley’s framework, we conducted a scoping review to categorise PPIE in the design and conduct of implementation research, including how patients and the public have been involved, the reported impact of patient and public involvement, and the reported benefits and challenges to involving patients and the public in implementation research. We searched four databases: MEDLINE, Embase, CINAHL, and SCOPUS. To be included, studies had to report some form of PPIE in the design and conduct of implementation research. Information about each study was extracted using a structured data extraction form. Data was collated and summarised. Results: Of the 535 unique records identified, 12 were included. Analysis of the eligible studies found eight different types of PPIE activities. Researchers mostly consulted with patients and members of the public via feedback sessions, committee representation and roundtable discussions. Barriers and enablers were usually researcher related and their attempts to build, maintain, and negotiate relationships with public contributors over time. Resources and financial remuneration were also key. Most studies (n = 7) reported that engaging community members in the design and implementation of community-based programs and trials enhanced cultural appropriateness, and the likelihood of sustainability. However, there was little formal evaluation of the use of PPIE. Conclusion: This study can be used to design and guide future PPIE in implementation research. Given the inconsistent, and often absent, reporting of PPIE activities and barriers and enablers across the included studies, future studies should describe and evaluate the execution of PPIE in implementation research to advance practices in this field. Registration: The review was registered on Research Registry (reviewregistry1552).

Objectives VICTORION-Spirit was a hybrid study designed to assess the feasibility of implementing inclisiran, a novel cholesterol-lowering treatment and behavioural support within primary care centres in England. This process evaluation aimed to evaluate the implementation of inclisiran for patients with elevated low-density lipoprotein cholesterol and atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (n=900), from the perspectives of key stakeholders. Design VICTORION-Spirit was a phase IIIb, multicentre, randomised, controlled study. We followed a process evaluation strategy to collate the views of stakeholders via semistructured interviews and to gain insights on the ‘implementability’ of inclisiran in primary care. Data were generated via interviews with patients, healthcare providers and research nurses and analysed using a qualitative rapid analysis approach. Setting Primary care in Greater Manchester, UK. Participants 84 participants were interviewed, including patients (n=56), professionals at participating practices in VICTORION-Spirit (n=13), health advisors (n=4) and research nurses (n=11). Results Interim findings suggest the process of receiving and providing inclisiran during the study was ‘straightforward’, and the behavioural support provided to some patients was generally viewed favourably. Beyond the trial, patients and healthcare providers thought the delivery of inclisiran could work well as a practice nurse-provided service. Barriers to implementing inclisiran were generally related to workforce and workload pressures in primary care, and an incentive structure to support delivery was recommended. Conclusions Patients and healthcare providers supported implementing inclisiran in primary care. It was convenient for patients to receive inclisiran in general practice, and most providers felt that the intervention was a useful addition to existing lipid-lowering treatments. Several barriers to implementation were highlighted, including concerns relating to general practice resources and costs. Trial registration number NCT04807400.

Background: Calls have been made for paramedics to have some form of care pathway that they could use to safely divert adults with epilepsy away from emergency departments and instigate ambulatory care improvements. Different configurations are possible. To know which to prioritise for implementation/evaluation, there is a need to determine which are acceptable to service users and likely National Health Service-feasible. Objective(s): (1) Identify configurations being considered, (2) understand service users’ views of them and current provision, (3) identify what sort of care service users want and (4) determine which configuration(s) is considered to achieve optimal balance in meeting users’ preference and being National Health Service-feasible. Design: Service providers were surveyed to address objective 1. Interviews with service users addressed objective 2. Objective 3 was addressed by completing discrete choice experiments. These determined users’ care preferences for different seizure scenarios. Objective 4 was addressed by completing ‘knowledge exchange’ workshops. At these, stakeholders considered the findings on users’ stated preferences and judged different pathway configurations against Michie’s ‘acceptability, practicability, effectiveness, affordability, side-effects and equity’ feasibility criteria. Setting: This project took place in England. The survey recruited representatives from neurology and neuroscience centres and from urgent and emergency care providers. For the interviews, recruitment occurred via third-sector support groups. Recruitment for discrete choice experiments occurred via the North West Ambulance Service NHS Trust and public advert. Workshop participants were recruited from neurology and neuroscience centres, urgent and emergency care providers, support groups and commissioning networks. Participants: Seventy-two services completed the survey. Interviews were conducted with 25 adults with epilepsy (and 5 relatives) who had emergency service contact in the prior 12 months. Discrete choice experiments were completed by 427 adults with epilepsy (and 167 relatives) who had ambulance service contact in the prior 12 months. Workshops were completed with 27 stakeholders. Results: The survey identified a range of pathway configurations. They differed in where they would take the patient and their potential to instigate ambulatory care improvements. Users had been rarely consulted in designing them. The discrete choice experiments found that users want a configuration of care markedly different to that offered. Across the seizure scenarios, users wanted their paramedic to have access to their medical records; for an epilepsy specialist (e.g. an epilepsy nurse, neurologist) to be available to advise; for their general practitioner to receive a report; for the incident to generate an appointment with an epilepsy specialist; for the care episode to last < 6 hours; and there was a pattern of preference to avoid conveyance to emergency departments and stay where they were. Stakeholders judged this configuration to be National Health Service-feasible within 5–10 years, with some elements being immediately deployable. Limitations: The discrete choice experiment sample was broadly representative, but those reporting recent contact with an epilepsy specialist were over-represented. Conclusions: Users state they want a configuration of care that is markedly different to current provision. The configuration they prefer was, with support and investment, judged to likely be National Health Service-feasible. The preferred configuration should now be developed and evaluated to determine its actual deliverability and efficacy. Study registration: The study is registered as researchregistry4723. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/05/62) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 24. See the NIHR Funding and Awards website for further award information.

Context In the context of iterative feedback loops to support real-time policy decision making, and an emphasis on speeding up adoption of evidence-based interventions, qualitative healthcare researchers are increasingly expected to produce rapid results and products. Traditional qualitative methods have been adapted for this purpose. Objective To develop and apply a rapid analysis framework in a process evaluation for the VICTORION-Spirit study; a ground-breaking hybrid trial examining real-world delivery of inclisiran—a cholesterol-lowering treatment—in primary care. Design We developed a rapid analysis framework, using a summary template, to analyse data from semistructured telephone interviews. Setting Primary care in Greater Manchester, UK. Participants Patients who had received inclisiran as part of the VICTORION-Spirit trial (56), providers delivering inclisiran (28) and representatives from the Academic Health Science Network (8) participated in the original study. Results The rapid analysis framework we developed and applied comprised six steps: (1) creating a summary template based on the five Consolidated Framework for Implementation Research domains; (2) test-driving, refining and finalising the summary template; (3) completing the template soon after each interview using field notes; (4) discussing analysis as a team; (5) transferring summaries to a matrix; and (6) using the summary matrix to inform presentations and interim reports for stakeholders. Our rapid analysis framework saved time and improved efficiency, as we were able to feedback barriers to stakeholders in real time via presentations. Conclusions Rapid analysis in applied healthcare research can produce timely and trustworthy findings. Our rapid analysis framework would be useful within studies where there is a need to feedback to stakeholders and adjust implementation strategies accordingly in real time. Thus, supporting successful implementation efforts and accelerating adoption. Trial registration number NCT04807400, 19/03/2021.

Aim: To explore the introduction of an evidence-based information intervention – the ‘Caring for Someone with Cancer’ booklet – within home care and end-of-life care, to inform future implementation and practice development within this setting.Background: Family carers’ contribution is crucial to enable care and death of people at home. The ‘Caring for Someone with Cancer’ booklet received positive responses from family carers and District Nurses and is an evidence-based intervention designed to support carers to deliver basic nursing tasks. Further feasibility work was required to establish how it should be implemented. Little is known about how to successfully translate interventions into practice, particularly within home care settings and end-of-life care.Methods: Implementation of the ‘Caring for Someone with Cancer’ booklet, utilising a qualitative case study approach, in four home care sites. Semi-structured interviews, informed by Normalization Process Theory (NPT), were undertaken at implementation sites in May 2016–June 2017. Participants were generalist and specialist nurses, managers, and Healthcare Assistants (HCAs). A framework approach to analysis was adopted.Findings: Forty-five members of staff participated. Failed implementation was associated with organisational-level characteristics and conditions, including workforce composition and predictability of processes. Unstable work environments meant home care providers focused on short-term rather than long-term goals, precluding practice development. Staff’s perceptions of the time available to engage with and implement the intervention inhibited adoption, as many participants were“just getting through the day”. Implementation was successful in sites with explicit management support, including proactive implementation attempts by managers, which legitimatised the change process, and if all staff groups were engaged. To encourage uptake of evidence-based interventions in home care settings, practitioners should be given opportunities to critically reflect upon taken-for-granted practices. Future implementation should focus on work pertaining to the NPT construct ‘Collective Action’, including how staff interact and build confidence in new practices.

Background and aim: Patient and public involvement (PPI) has potential to enhance health‐care research and is increasingly an expectation, particularly for many funding bodies. However, PPI can be tokenistic, which may limit this potential. Furthermore, few studies report PPI processes and impact, particularly in doctoral research studies, which are seldom reported in peer‐reviewed papers. The aim of this paper was to explore the impact of PPI on two health‐related doctoral research studies and identify how PPI could be used meaningfully at this level.Method: The PPI processes included (a) involvement of two ‘Research Buddies’ who informed the research design and ensured implementation of a booklet intervention was feasible for family carers, (b) data analysis workshops with ‘Research Buddies’ to identify emerging themes from practitioner interviews, (c) public and stakeholder involvement who informed data collection tool design, and the design of an intervention to help people with obesity who attend weight loss groups.Findings: The application of PPI enhanced both doctoral studies by assisting data analysis; problem solving and improving recruitment rates; improving the usability and appeal of data collection tools and interventions; and developing implementation strategies. Patient and public involvement was considered a rewarding experience for both researchers and PPI contributors.Conclusion: This paper demonstrates the value of PPI in doctoral research in relation to its impact on research processes, researchers and contributors. We also present recommendations on how PPI could be incorporated into future doctoral research, including resources required, planning PPI processes and involving PPI contributors in all stages of research.