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The 100,000 Genomes Project (the ‘Project’), announced in December 2012, was established to: • develop new capability and capacity in genomic medicine in order to transform the provision of health services in England; • create new capability for clinical genomics research and • establish an infrastructure for the protection and analysis of clinical and genomic data. The primary mechanism to achieve these aims was through sequencing 100,000 genomes from patients with cancers, rare disorders and infectious diseases, linking the resultant sequence data to a standardised, extensible account of diagnosis, treatment and outcomes. The Project achieved its goal of sequencing 100,000 genomes in December 2018. The Policy Innovation and Evaluation Research Unit (PIRU) at London School of Hygiene and Tropical Medicine (LSHTM) was asked by the then Department of Health to conduct a qualitative study exploring the experiences of those people who donated their DNA to the Project (‘participants’) and the experiences of health care staff involved in the Project, as well as the public’s perceptions of genomic research more generally. Data collection for the current study took place between late 2015 and late 2017. The aims of this study were to: • Understand the motivation of people who agreed to take part in the 100,000 Genomes Project; their experiences of receiving information, giving consent and taking part; their attitudes to data sharing, governance and confidentiality and their views about feedback and use of their Project data for research and clinical care. • Learn about the experiences of clinicians who asked people to take part in the Project. • Explore the understanding and perceptions of members of the public of genomic research in general. • Explore the understanding and perceptions of the non-specialist NHS workforce of genomic research in general, and of the 100,000 Genomes Project in particular, and to identify potential training needs related to any roll-out of genomic medicine services in the NHS. • Draw on the above, in order to make suggestions for improvement, thereby improving the likelihood of the Project achieving its goals. This summary report complements the full report of the study which sets out the methods and findings in greater detail (Ryan et al., 2020). There is also a related section on the healthtalk website (healthtalk.org/experiences-participating-100000genomes-project) which draws on this study’s interviews with participants. It includes eight educational films covering differing aspects of the experience of taking part in the 100,000 Genomes Project: • being invited to take part; • concerns about taking part; • reasons for wanting to take part; • deciding to take part; • sample storage; • data protection and sharing; • thoughts on medical research and genomic medicine; • messages for health professionals and Genomics England. This resource will be of interest and of use to healthcare professionals, policy makers and the general public.

Meeting abstract from the 5th International Clinical Trials Methodology Conference (ICTMC 2019) https://ictmc2019.com/

Plain English summary Patient or user involvement in health research is well-established but is often limited to advising on research questions and design, leaving researchers to collect and analyse ‘data’ (which in this paper means written copies of interviews with patients about their experiences). We were working with sets of interviews with 1) young people with depression and 2) people with experiences of stroke. We were looking for key themes that it would be useful for the NHS to know about, and we developed short films which healthcare staff can use to think about how to make care more patient-centred. We wanted to see what user involvement in this analysis would bring, and how best to achieve it practically. After the researcher team had analysed the interviews, we ran two one-day workshops with people with relevant experience as a patient/service user or carer. We gave them some brief training in how to analyse interviews and how they might be used for improving the quality of care. Then we looked at extracts from the interviews, and discussed whether people could see the same themes as the researcher. People identified similar themes to the researcher, but also identified new details the researcher had missed. However, they felt reading large amounts of text was not the best way to use their time and experience. Instead they recommended that a better approach would be for a researcher to meet with a group of users at the start of analysis, to discuss what to look out for. Abstract Background Patient or user involvement in health research is a well-established principle. However, involvement is often limited to advising on research questions and design, leaving researchers to complete data collection and analysis. Involvement in data analysis is one of the most challenging, least well-explored aspects of involvement. Qualitative interview data forms high volumes of rich, complex material which can be daunting to work with. Analysing narrative interviews with patients is central to a patient-centred quality improvement method called experience-based co-design. The analysis identifies ‘touchpoints’ – key moments of healthcare experiences – and leads to the production of a ‘trigger film’ to spark codesign discussions between patients and staff. We wanted to see what user involvement in this analysis would bring, and how best to achieve it. Methods As part of a wider secondary analysis study to create new trigger films, we re-analysed interview transcripts on experiences of young people with depression and experiences of stroke. We then ran two workshops with people with relevant lived experience, working with extracts from the same materials after brief training. Results People involved in the workshops identified similar themes to the researcher, but also brought some new insights. While they engaged easily with the materials selected, we under-estimated how much time it would take people to work through these. Discussion and sharing experiences and perspectives were highly valued in the first workshop. In the second workshop, we therefore started with group discussion, based on people’s own experience, of what they thought the touchpoints would be, and later viewed a draft trigger film together to see how it compared. Conclusions Those involved felt that while analysing transcripts was possible in small quantities, it was not best use of their time. We suggest that conversation, rather than data, is at the heart of user involvement in analysis. One way to retain the value of lived experience in the analytic process, without over-burdening people with data, is to elicit user reflections on their experience at the start of analysis, and use this as a guide to direct both researcher and service user attention during the remainder of the process.

Objectives To illuminate patterns observed in International Cancer Benchmarking Programme studies by extending understanding of the various influences on presentation and referral with cancer symptoms. Design Cross-country comparison of Denmark, England, and Sweden with qualitative analysis of in-depth interview accounts of the pre-diagnostic process in lung or bowel cancer. Participants 155 women and men, aged between 35 and 86 years old, diagnosed with lung or bowel cancer in the six months before interview. Setting Participants recruited through primary and secondary care, social media, and word-of-mouth. Interviews collected by social scientists or nurse researchers during 2015, mainly in participants’ homes. Results Participants reported difficulties in interpreting diffuse bodily sensations and symptoms and deciding when to consult. There were examples of swift referrals by primary care professionals in all three countries. In all countries participants described difficulty deciding if and when to consult, highlighting concerns about access to GP appointments and overstretched primary care services, although this appears less prominent in the Swedish data. It was not unusual for there to be more than one consultation before referral and we noted two distinct patterns of repeated consultation: (1) Situations where the participant left the primary care consultation with a plan of action about what should happen next. (2) Participants were unclear about under which conditions to return to the doctors. This second pattern sometimes extended over many weeks during which patients described uncertainty, and sometimes frustration, about if and when they should return and whether there were any other feasible investigations. The latter pattern appeared more evident in the interviews in England and Denmark than Sweden. Conclusion We suggest that if clear action plans, as part of safety netting, were routinely used in primary care consultations then uncertainty, false reassurance, and the inefficiency and distress of multiple consultations could be reduced.

How are the social relations of collaboration enacted? In this paper, we address this question by analysing a meeting of researchers at the University of Oxford and the Picker Institute, teams of frontline staff from six National Health Service (NHS) trusts, and a ‘lay panel’, brought together for the US-PEx project.

Objectives: to explore the involvement of mental health service users in the redesign of in-patient mental health services in six Trusts participating in a multi-regional NHS modernisation programme. Design: semi-structured interviews and observation of team meetings undertaken as part of an action research study. Participants and setting: users, clinical, medical and managerial staff from six mental health trusts which participated in the Northern & Yorkshire and Trent regions? Mental Health Collaborative (MHC). Results and conclusions: whilst there were some problems, user involvement was undoubtedly a strength of the MHC in comparison to other modernisation programmes within the NHS we have studied. However, the particular challenges posed by the specific context of acute mental health services should not be overlooked. The initial approach taken in each of the sites was to simply invite a user or user representative to join the local project team. In the course of events, various changes were made to this initial mechanism for involving users in the ongoing work of the teams. These changes - and setbacks in some sites - make drawing firm conclusions as to the effectiveness of the various strategies employed problematic. However, our qualitative data suggest a number of broad lessons which will assist both those leading and participating in other redesign initiatives to maximise the benefits to be gained from service user involvement.

A study of four HAs in three regions found that they had little influence on encouraging trusts to implement the recommendations of the Changing Childbirth report over the period 1993-98. Where changes had been introduced this was often through the influence of an opinion leader in the trust, such as directors of midwifery. The results suggest healthcare professionals providing services have substantial influence over the fate of strategic change initiatives.

This article examines the changing nature of the central organization of the NHS and its relations with the field. It is based on a two-year tracer study of regional health authorities (RHAs) as they were reorganized into regional offices (ROs) and became part of the civil service. The research evidence suggests that the centre of the NHS cannot be treated as one organization; the wider Department of Health, NHS Executive HQ and regional offices have distinct identities within it. The analysis therefore looks at relations between these different components of the centre, and between them and the field. The significance of the recent White Paper for the future of regional offices is discussed, with particular emphasis on the tension between centralization and decentralization in performance management, and the opportunity to rebuild strategic co-ordination, which has been difficult to maintain under the internal market.

Pressure to utilize research evidence in decisions about patient care and population health, so-called evidence-based medicine, has swept the health care systems of most industrial countries. In the UK, the attention of policy makers has recently turned from the production of more 'effectiveness information' to the more fundamental challenge of understanding the factors involved in influencing the attitudes and practices of health care professionals. This article seeks to contribute to this process by reporting the findings of an evaluation of a clinical effectiveness initiative established in Wales between 1996-9 (Locock et al . 1999). The study shows that a number of different factors are involved in improving the implementation of effectiveness information, including the strength of the evidence, and the role of peer influence. However it is the interaction of various elements rather than any single factor, which appears to be crucial. These findings are important not only for health but for informing future interventions across other parts of the public sector.

Evidence-based medicine was one of the earliest manifestations of evidence-based policy and practice, and has exercised substantial influence on other policy areas. Based on data from seven empirical studies carried out between 1993 and 1999, this article examines the origins and impact of EBM, and the complexities of implementation which have emerged. Policy makers and EBM enthusiasts alike have frequently taken a somewhat simplistic view of the implementation gap they seek to address. Understanding clinicians’ mixed reactions to the rhetoric of EBM helps explain both why EBM has had as much impact as it has, and why it has sometimes been resisted and rejected. Although other areas of public policy can learn from the experience of EBM, there are distinctive features of health care which set it apart, notably the continued autonomy and dominance of the medical profession and the strong influence of the biomedical science model on what is considered legitimate evidence.

The affiliation for the second author is incomplete. Louise Locock should have the following added to her affiliation: Health Experiences Fellow, NIHR Oxford Biomedical Research Centre.

This article focuses on the diffusion and adoption of innovations in clinical practice. The authors are specifically interested in underresearched questions concerning the latter stages of the creation, diffusion, and adoption of new knowledge, namely: What makes this information credible and therefore utilized? Why do actors decide to use new knowledge? And what is the significance of the social context of which actors are a part?

Studies of maternal mortality have been shown to result in important improvements to women’s health. It is now recognised that in countries such as the UK, where maternal deaths are rare, the study of near-miss severe maternal morbidity provides additional information to aid disease prevention, treatment and service provision. Objectives To (1) estimate the incidence of specific near-miss morbidities; (2) assess the contribution of existing risk factors to incidence; (3) describe different interventions and their impact on outcomes and costs; (4) identify any groups in which outcomes differ; (5) investigate factors associated with maternal death; (6) compare an external confidential enquiry or a local review approach for investigating quality of care for affected women; and (7) assess the longer-term impacts. Methods Mixed quantitative and qualitative methods including primary national observational studies, database analyses, surveys and case studies overseen by a user advisory group. Setting Maternity units in all four countries of the UK. Participants Women with near-miss maternal morbidities, their partners and comparison women without severe morbidity. Main outcome measures The incidence, risk factors, management and outcomes of uterine rupture, placenta accreta, haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome, severe sepsis, amniotic fluid embolism and pregnancy at advanced maternal age (≥ 48 years at completion of pregnancy); factors associated with progression from severe morbidity to death; associations between severe maternal morbidity and ethnicity and socioeconomic status; lessons for care identified by local and external review; economic evaluation of interventions for management of postpartum haemorrhage (PPH); women’s experiences of near-miss maternal morbidity; long-term outcomes; and models of maternity care commissioned through experience-led and standard approaches. Results Women and their partners reported long-term impacts of near-miss maternal morbidities on their physical and mental health. Older maternal age and caesarean delivery are associated with severe maternal morbidity in both current and future pregnancies. Antibiotic prescription for pregnant or postpartum women with suspected infection does not necessarily prevent progression to severe sepsis, which may be rapidly progressive. Delay in delivery, of up to 48 hours, may be safely undertaken in women with HELLP syndrome in whom there is no fetal compromise. Uterine compression sutures are a cost-effective second-line therapy for PPH. Medical comorbidities are associated with a fivefold increase in the odds of maternal death from direct pregnancy complications. External reviews identified more specific clinical messages for care than local reviews. Experience-led commissioning may be used as a way to commission maternity services. Limitations This programme used observational studies, some with limited sample size, and the possibility of uncontrolled confounding cannot be excluded. Conclusions Implementation of the findings of this research could prevent both future severe pregnancy complications as well as improving the outcome of pregnancy for women. One of the clearest findings relates to the population of women with other medical and mental health problems in pregnancy and their risk of severe morbidity. Further research into models of pre-pregnancy, pregnancy and postnatal care is clearly needed.

Trusts vary greatly on their progress in achieving waiting-list targets, particularly for 2005. A study of trusts with a range of performances identified four key criteria: information use, managerial focus, capacity and long-term efficiency. Actions that help a trust 'catch up' rarely help them 'keep up; strategies may need to change once waiting lists have fallen markedly. Flexibility, forward planning and 'expecting the unexpected' are characteristics of successful trusts.

Background: Many individuals with type 2 diabetes are reluctant to accept insulin treatment. As a complementary resource to formal support, an intervention based on shared patient experience might be able to facilitate such a process. Presently, however, there are many uncertainties about the evidence to support the pragmatic use of shared patient experience. Methods: Several research techniques were used to examine these issues. A review of existing systematic reviews was conducted to clarify the idea of shared patient experience in a context of type 2 diabetes management in general. Second, a systematic review explored the impact of shared patient experience on health in adults with type 2 diabetes. Third and fourth, two linked studies, a narrative literature review of qualitative studies and a secondary analysis of an existing collection of qualitative interviews examined patients’ attitudes, experiences, information/support needs in relation to the initiation of insulin therapy. Fifth, a primary qualitative study investigated patients’ views and preferences toward the use of shared patient experience to support the process of decision-making in starting insulin. Finally, a proposed intervention design was developed based on all the evidence provided by the previous studies. Results: More new knowledge was contributed to the field of shared patient experience in diabetes care by identifying a working definition of shared patient experience, some common components of shared patient experience and some studies highlighting the evidence of the effects of shared patient experience on disease-related health in type 2 diabetes. It also revealed the patients’ reluctance about moving onto insulin, concerns about the lack of communication about insulin with their healthcare providers prior to insulin, a range of valuable potential shared patient experience has to help patients in the decision-making process, and the patients’ preferences about different formats of shared patient experience. This evidence suggested that shared patient experience, delivered though a face-to-face one-to-one discussion and/or an online curated collection of the filmed narrative interview material conveying certain key elements of peers’ stories, could be an appropriate, efficient and acceptable way to deliver such an intervention in the context of insulin decision-making in type 2 diabetes. Conclusion: There are still many patients being left with psychological concerns about insulin and without sufficient support to overcome such concerns, suggesting a need for additional support which can be delivered as a supplement to formal support provided by healthcare professionals. Shared patient experience could be one of the potential strategies to help ease the process of insulin decision-making.

Recent decades have seen increasing recognition of the importance of patient involvement during patient-professional interactions and promotion of preventative and long term approaches to healthcare for those with long-term conditions. The concepts of 'shared decision making' and ‘personalised care planning’ have both been advocated by patient groups, policy-makers, professional bodies and academia as best practice. During shared decision making, patients and healthcare professionals work in equal partnership to decide the best course of action. Shared decision making is a central tenet of personalised care planning, as it aims to foster partnerships between patients and healthcare professionals when making decisions, but personalised care planning also describes an overall approach to healthcare that is forward-planning and preventative, rather than episodic and reactive. Despite the breadth of support for such approaches, in reality they are not routinely adopted. Multiple Sclerosis (MS) is a heterogeneous neurodegenerative long term condition, which is unpredictable with limited treatments available. Such uncertainty and complexity position MS as an interesting long term condition to explore decisional and information needs. This doctoral research comprises of three methods stages. Firstly, two systematic reviews assessing the effectiveness of personalised care planning for people with long-term conditions and people with MS were carried out. Secondly, 22 in-depth semi-structured qualitative interviews were carried out with people with MS across the UK to explore experiences of decision making and interactions with healthcare professionals. Purposive sampling was carried out and data saturation determined sample size. A modified grounded theory approach was used and thematic analysis of interview data was carried out. Lastly, a series of structured qualitative interviews were carried out with 6 consultant neurologists. This stage was iterative in that problematic areas identified during analysis of interview data from stage 2 were presented to neurologists in infographic form to further examine issues raised. Framework analysis was carried out on neurologist interview data to examine their interpretations and potential solutions. Although there appears to be some evidence demonstrating that personalised care planning is effective for people with long term conditions, such favourable effects were not demonstrated in the context of MS. Based on the findings from the systematic reviews it is unclear whether personalised care planning is effective for people with MS and there is a clear gap in the literature examining this. Findings from the interview stages suggest there are key areas which are lacking in terms of information and decisional support. Such areas included the type and amount of information around the time of diagnosis, support when choosing disease modifying drugs and discussions about approaches outside mainstream medicine. Findings from neurologist interview data corroborated those from MS interview data, but through examination of issues raised it also highlighted some of the complexities and challenges of involving patients and enacting shared decision making in reality. This research identified key areas that require improvement for people with MS in terms of provision of the information and decisional support. Although in theory personalised care planning and shared decision making are positioned as best practice, in reality it is unclear whether they are effective or appropriate for people with MS. The way in which such approaches are enacted are complex and require careful consideration. Potential barriers and pitfalls identified within this study suggest a lack of clarity in how to respond to challenges and further investigation into how patient involvement is enacted is needed.

Encouraging people to make healthier food choices will make an important contribution to preventing non-communicable diseases. Most groceries purchased by UK households are from supermarkets, potentially making this an important setting where consumers might consider the nutritional quality of foods. While it is possible to purchase healthy food in supermarkets, the retail environment actively promotes the selection of less healthy items. Gaps remain in our understanding about which store based interventions - including providing on-pack nutrition information - can assist shoppers to make healthy food selections. Considerable evidence exists around consumer engagement with nutrition labelling, but there is a paucity of research conducted in real-life contexts. This thesis describes a qualitative study which explored factors which influence decision making at point-of-choice and sought to understand whether and how shoppers use the front of pack nutrition information panel during routine supermarket shopping. The study also investigated whether wearable cameras were useful research tools to understand how shoppers use the front of pack nutrition information panel, compared to a 'Think aloud' method. In this research, participants paid little attention to the front of pack nutrition information as they shopped. Food shopping was characterised as a complex, involved activity with priority given to a range of different issues over health and/or nutrition concerns. Although the front of pack nutrition information panel could offer support to shoppers, this study suggests that its presence is currently overwhelmed by commercially driven factors. Shoppers appear to need specific health or nutrition-related purchasing goals, be sufficiently informed and motivated to spend time attending to the front of pack nutrition information panel. Future interventions should raise awareness of the presence of nutrition information on pack and be clear about how this information can be used in different circumstances to guide consumers towards healthier choices. The study suggests that while data collected via 'Think aloud' or from viewing wearable camera images provides general information about food shopping decisions, eye-tracker technology can provide objective evidence of nutrition information use. Data capture was greatly strengthened by the use of a post-shop interview, where interviews generated specific and important contextual information relating to the use of the front of pack nutrition information panel.

Background The term patient-centred care (PCC) is commonly used in the academic literature and UK health policy. However, this concept is ill defined and little is known about its applicability to the management of people with long-term conditions (LTCs). Several methodologies were used to explore the meaning of PCC, identify key experiences that matter to people with LTCs and consider the implications of these findings for the measurement of patient reported experiences of health care. Method Four stages of research were conducted for this thesis. First, a conceptual synthesis of existing PCC and patient experience frameworks to produce an overarching framework of PCC. Second, secondary qualitative analysis of patient interviews to identify key experiences of PCC that matter to people with LTCs. Third, development of a PCC questionnaire for people with LTCs, based on findings from the conceptual synthesis and secondary analysis. Fourth, further exploration of the questionnaire through cognitive debriefing interviews with people with LTCs and health professionals. Results The overarching framework of PCC consisted of 8 domains; access, availability and choice, information, communication and education, relationship with health professionals, involvement in care, respect and dignity, responsiveness to individual needs and preferences, consistency, continuity and co-ordination, and effectiveness of treatment and care. Findings from secondary analysis suggested that many of the domains from the framework were also important in care for people with LTCs, but that some aspects of care held an additional meaning. The themes identified in the secondary analysis were used to generate items for a generic PCC experience questionnaire for people with LTCs. The final questionnaire, ‘Your Experiences of Care in Long-Term Conditions’ consisted of 47 questions across three sections. Feedback from the debriefing interviews suggested that the questionnaire had asked important questions about care for people with LTCs and that it was relevant to people with a range of different LTCs. Conclusion Development of an overarching framework of PCC demonstrated some conceptual problems in understanding and evaluating the notion of PCC. Findings from this thesis suggest that an overarching questionnaire of experiences of PCC is feasible and acceptable to people with a range of different LTCs. Future research needs examine standard features of the newly developed PCC experience questionnaire for people with LTCs and consider the potential use and contribution of data in enhancing care for people with LTCs.