The social licence for research: why care.data ran into trouble.

In this article we draw on the concept of a social licence to explain public concern at the introduction of care.data, a recent English initiative designed to extract data from primary care medical records for commissioning and other purposes, including research. The concept of a social licence describes how the expectations of society regarding some activities may go beyond compliance with the requirements of formal regulation; those who do not fulfil the conditions for the social licence (even if formally compliant) may experience ongoing challenge and contestation. Previous work suggests that people's cooperation with specific research studies depends on their perceptions that their participation is voluntary and is governed by values of reciprocity, non-exploitation and service of the public good. When these conditions are not seen to obtain, threats to the social licence for research may emerge. We propose that care.data failed to adequately secure a social licence because of: (i) defects in the warrants of trust provided for care.data, (ii) the implied rupture in the traditional role, expectations and duties of general practitioners, and (iii) uncertainty about the status of care.data as a public good. The concept of a social licence may be useful in explaining the specifics of care.data, and also in reinforcing the more general lesson for policy-makers that legal authority does not necessarily command social legitimacy.

How to study improvement interventions: a brief overview of possible study types.

Improvement (defined broadly as purposive efforts to secure positive change) has become an increasingly important activity and field of inquiry within healthcare. This article offers an overview of possible methods for the study of improvement interventions. The choice of available designs is wide, but debates continue about how far improvement efforts can be simultaneously practical (aimed at producing change) and scientific (aimed at producing new knowledge), and whether the distinction between the practical and the scientific is a real and useful one. Quality improvement projects tend to be applied and, in some senses, self-evaluating. They are not necessarily directed at generating new knowledge, but reports of such projects if well conducted and cautious in their inferences may be of considerable value. They can be distinguished heuristically from research studies, which are motivated by and set out explicitly to test a hypothesis, or otherwise generate new knowledge, and from formal evaluations of improvement projects. We discuss variants of trial designs, quasi-experimental designs, systematic reviews, programme evaluations, process evaluations, qualitative studies, and economic evaluations. We note that designs that are better suited to the evaluation of clearly defined and static interventions may be adopted without giving sufficient attention to the challenges associated with the dynamic nature of improvement interventions and their interactions with contextual factors. Reconciling pragmatism and research rigour is highly desirable in the study of improvement. Trade-offs need to be made wisely, taking into account the objectives involved and inferences to be made.

Public priorities for joint pain research: results from a general population survey.

OBJECTIVE: We aimed to identify the priorities for joint pain research from a large general population survey and identify characteristics associated with these priorities. METHODS: A question about research priorities was developed in collaboration with the Arthritis Research UK Primary Care Centre's Research Users' Group. The question was embedded in a postal survey to an existing cohort of adults with self-reported joint pain, aged ≥56 years, in North Staffordshire. Respondents were asked to rank their top three priorities for research. Factor mixture modelling was used to determine subgroups of priorities. RESULTS: In all, 1756 (88%) people responded to the survey. Of these, 1356 (77%) gave three priorities for research. Keeping active was rated the top priority by 38%, followed by research around joint replacement (9%) and diet/weight loss (9%). Two clusters of people were identified: 62% preferred lifestyle/self-management topics (e.g. keeping active, weight loss) and 38% preferred medical intervention topics (e.g. joint replacement, tablets). Those who preferred the medical options tended to be older and have hip or foot pain. CONCLUSION: This study has provided population data on priorities for joint pain research expressed by a large cohort of older people who report joint pain. The most popular topics for research were linked to lifestyle and self-management opportunities. Pharmaceutical and invasive interventions, despite being common topics of research, are of less importance to these respondents than non-medical topics. Specific research questions will be generated from this study with collaboration of the patient's group.

How treatment burden affects the carer: the experiences of three individuals, a mother, a daughter and a husband.

The burden of treatment extends beyond the patient and can have a dramatic impact on the person in a caring role. https://bit.ly/3oekJjo.

Six sigma.

When I was first introduced to the Six Sigma process, I resisted it with every ounce of energy I had. I continuously fabricated reasons so that I was unable to complete the training that my company required. When it came time for my performance review, I could not hide the truth from my manager; I had not completed the required training. It was then that I began my journey into the world of Six Sigma. Once I understood that a black belt and a green belt certification had nothing to do with karate, I felt much better.

Major health service transformation and the public voice: conflict, challenge or complicity?

Objectives Calls for major reconfigurations of health services have been accompanied by recommendations that wide ranging stakeholders be involved. In particular, patients and the wider public are seen as critical contributors as both funders and beneficiaries of public health care. But public involvement is fraught with challenges, and little research has focused on involvement in the health service transformation initiatives. This paper examines the design and function of public involvement in reconfiguration of health services within the English NHS. Methods Qualitative data including interviews, observation and documents were collected in two health service 'transformation' programmes; interviews include involved public and professional participants. Data were analysed using parallel deductive and inductive approaches. Results Public involvement in the programmes was extensive but its terms of reference, and the individuals involved, were restricted by policy pressures and programme objectives. The degree to which participants descriptively or substantively represented the wider public was limited; participants sought to 'speak for' this public but their views on what was 'acceptable' and likely to influence decision-making led them to constrain their contributions. Conclusions Public involvement in two major service reconfiguration programmes in England was seen as important and functional, and could not be characterized as tokenistic. Yet involvement in these programmes fell short of normative ideals, and could inadvertently reduce, rather than enlarge, public influence on health service reconfiguration decisions.

Challenges Facing Healthwatch, a New Consumer Champion in England.

This article engages with debates about the conceptualisation and practical challenges of patient and public involvement (PPI) in health and social care services. Policy in this area in England has shifted numerous times but increasingly a consumerist discourse seems to override more democratic ideas concerning the relationship between citizens and public services. Recent policy change in England has seen the creation of new consumer champion bodies in the form of local Healthwatch. The article describes these new organisational structures for PPI and shows how those who seek to influence planning and delivery of services or comment or complain about aspects of their care face considerable complexity. This is due, in part, to the ambiguous remit set out for newly instigated Healthwatch organisations by government. Drawing on governance theory, we show that it can also be understood as a function of an increasingly polycentric governance arena. Challenges that flow from this include problems of specifying jurisdictional responsibility, accountability, and legitimacy. We review Healthwatch progress to date, then we set out four challenges facing local Healthwatch organisations before discussing the implications of these for patients and the public. The first challenge relates to non-coterminous boundaries and jurisdictional integrity. Secondly, establishing the unique features of Healthwatch is problematic in the crowded PPI arena. The third challenge arises from limited resources as well as the fact that resources flow to Healthwatch from the local authorities that Healthwatch are expected to hold to account. The fourth challenge we identify is how local Healthwatch organisations negotiate the complexity of being a partner to statutory and other organisations, while at the same time being expected to champion local people's views.

Patient and public involvement in primary care research - an example of ensuring its sustainability.

BACKGROUND: The international literature on patient and public involvement (PPI) in research covers a wide range of issues, including active lay involvement throughout the research cycle; roles that patients/public can play; assessing impact of PPI and recommendations for good PPI practice. One area of investigation that is less developed is the sustainability and impact of PPI beyond involvement in time-limited research projects. METHODS: This paper focuses on the issues of sustainability, the importance of institutional leadership and the creation of a robust infrastructure in order to achieve long-term and wide-ranging PPI in research strategy and programmes. RESULTS: We use the case of a Primary Care Research Centre to provide a historical account of the evolution of PPI in the Centre and identified a number of key conceptual issues regarding infrastructure, resource allocation, working methods, roles and relationships. CONCLUSIONS: The paper concludes about the more general applicability of the Centre's model for the long-term sustainability of PPI in research.

How to study improvement interventions: a brief overview of possible study types.

Improvement (defined broadly as purposive efforts to secure positive change) has become an increasingly important activity and field of inquiry within healthcare. This article offers an overview of possible methods for the study of improvement interventions. The choice of available designs is wide, but debates continue about how far improvement efforts can be simultaneously practical (aimed at producing change) and scientific (aimed at producing new knowledge), and whether the distinction between the practical and the scientific is a real and useful one. Quality improvement projects tend to be applied and, in some senses, self-evaluating. They are not necessarily directed at generating new knowledge, but reports of such projects if well conducted and cautious in their inferences may be of considerable value. They can be distinguished heuristically from research studies, which are motivated by and set out explicitly to test a hypothesis, or otherwise generate new knowledge, and from formal evaluations of improvement projects. We discuss variants of trial designs, quasi-experimental designs, systematic reviews, programme evaluations, process evaluations, qualitative studies, and economic evaluations. We note that designs that are better suited to the evaluation of clearly defined and static interventions may be adopted without giving sufficient attention to the challenges associated with the dynamic nature of improvement interventions and their interactions with contextual factors. Reconciling pragmatism and research rigour is highly desirable in the study of improvement. Trade-offs need to be made wisely, taking into account the objectives involved and inferences to be made.

How collaborative are quality improvement collaboratives: a qualitative study in stroke care.

BACKGROUND: Quality improvement collaboratives (QICs) continue to be widely used, yet evidence for their effectiveness is equivocal. We sought to explain what happened in Stroke 90:10, a QIC designed to improve stroke care in 24 hospitals in the North West of England. Our study drew in part on the literature on collective action and inter-organizational collaboration. This literature has been relatively neglected in evaluations of QICs, even though they are founded on principles of co-operation and sharing. METHODS: We interviewed 32 professionals in hospitals that participated in Stroke 90:10, conducted a focus group with the QIC faculty team, and reviewed purposively sampled documents including reports and newsletters. Analysis was based on a modified form of Framework Analysis, combining sensitizing constructs derived from the literature and new, empirically derived thematic categories. RESULTS: Improvements in stroke care were attributed to QIC participation by many professionals. They described how the QIC fostered a sense of community and increased attention to stroke care within their organizations. However, participants' experiences of the QIC varied. Starting positions were different; some organizations were achieving higher levels of performance than others before the QIC began, and some had more pre-existing experience of quality improvement methods. Some participants had more to learn, others more to teach. Some evidence of free-riding was found. Benchmarking improvement was variously experienced as friendly rivalry or as time-consuming and stressful. Participants' competitive desire to demonstrate success sometimes conflicted with collaborative aims; some experienced competing organizational pressures or saw the QIC as duplication of effort. Experiences of inter-organizational collaboration were influenced by variations in intra-organizational support. CONCLUSIONS: Collaboration is not the only mode of behavior likely to occur within a QIC. Our study revealed a mixed picture of collaboration, free-riding and competition. QICs should learn from work on the challenges of collective action; set realistic goals; account for context; ensure sufficient time and resources are made available; and carefully manage the collaborative to mitigate the risks of collaborative inertia and unhelpful competitive or anti-cooperative behaviors. Individual organizations should assess the costs and benefits of collaboration as a means of attaining quality improvement.

Sustaining patient and public involvement in research: A case study of a research centre.

The literature on patient and public involvement (PPI) in research covers a wide range of topics. However, one area of investigation that appears under developed is the sustainability and impact of PPI beyond involvement in time-limited research projects. This paper presents a case study of PPI development in one primary care research centre in England, and its approach to making this sustainable using documentary sources and material from a formal evaluation. We provide narrative accounts of the set-up, operation and main processes of PPI, and its perceived impact. PPI requires a long-term perspective with participation and trust growing over time, and both users and researchers learning what approaches work best. PPI is a complex interplay of clarity of purpose, defined roles and relationships, organised support (paid PPI staff) and a well-funded infrastructure. 'Soft systems' are equally important such as flexible and informal approaches to meetings, adapting timetables and environments to meet the needs of lay members and to create spaces for relationships to develop between researchers and lay members that are based on mutual trust and respect. This case study highlights that the right combination of ethos, flexible working practices, leadership, and secure funding goes a long way to embedding PPI beyond ad hoc involvement. This allows PPI in research to be integrated in the infrastructure and sustainable.