Good conduct in a context of rationing: A case study of how frontline professionals deal with distributive dilemmas of novel gene therapies.

Classical dilemmas of how to distribute limited resources have been rekindled by the rise of advanced, high-cost therapies. Building on a case study of a novel gene therapy in neuropaediatric care, this article explores the dilemmas that explicit priority setting can create for frontline professionals and develops a typology of professionals' responses to these dilemmas. Despite political attempts to centralise priority setting and spare health professionals from having to consider treatment costs at the 'bedside', this study shows that concern for economic efficiency and budget control nonetheless need to be handled and balanced against other accountabilities in the daily work of frontline professionals. Contributing to the sociological debate on priority setting and rationing, this study develops an analytical perspective attuned to the relational aspects of frontline work and the challenges related to the balancing of diverging ideas of good conduct. Further, focussing on an empirical field at the forefront of genomic medicine, this study brings the sociological debate on priority setting and rationing up to date with current developments in precision medicine.

The practical ethics of repurposing health data: how to acknowledge invisible data work and the need for prioritization.

Throughout the Global North, policymakers invest in large-scale integration of health-data infrastructures to facilitate the reuse of clinical data for administration, research, and innovation. Debates about the ethical implications of data repurposing have focused extensively on issues of patient autonomy and privacy. We suggest that it is time to scrutinize also how the everyday work of healthcare staff is affected by political ambitions of data reuse for an increasing number of purposes, and how different purposes are prioritized. Our analysis builds on ethnographic studies within the Danish healthcare system, which is internationally known for its high degree of digitalization and well-connected data infrastructures. Although data repurposing ought to be relatively seamless in this context, we demonstrate how it involves costs and trade-offs for those who produce and use health data. Even when IT systems and automation strategies are introduced to enhance efficiency and reduce data work, they can end up generating new forms of data work and fragmentation of clinically relevant information. We identify five types of data work related to the production, completion, validation, sorting, and recontextualization of health data. Each of these requires medical expertise and clinical resources. We propose that the implications for these forms of data work should be considered early in the planning stages of initiatives for large-scale data sharing and reuse, such as the European Health Data Space. We believe that political awareness of clinical costs and trade-offs related to such data work can provide better and more informed decisions about data repurposing.

The sociology of rationing: Towards increased interdisciplinary dialogue - A critical interpretive literature review.

Since the 1990s, the sociology of rationing has developed in explicit opposition to health economic and bioethical approaches to healthcare rationing. This implies a limited engagement with other disciplines and a limited impact on political debates. To bring the sociology of rationing into an interdisciplinary dialogue, it is important to understand the disciplines' analytical differences and similarities. Based on a critical interpretive literature synthesis, this article examines four disciplinary perspectives on healthcare rationing and priority setting: (1) Health economics, which seeks to develop decision models to provide for more rational resource allocation; (2) Bioethics, which seeks to develop normative principles and procedures to facilitate a just allocation of resources; (3) Health policy studies, which focus on issues of legitimacy and implementation of decision models; and lastly (4) Sociology, which analyses the uncertainty of rationing and the resulting value conflicts and negotiations. The article provides an analytical overview and suggestions on how to advance the impact of sociological arguments in future rationing debates: Firstly, we discuss how to develop the concepts and assumptions of the sociology of rationing. Secondly, we identify specific themes relevant for sociological inquiry, including the recurring problem of how to translate administrative priority setting decisions into clinical practice.

Physician-industry collaboration: conflicts of interest and the imputation of motive.

Policies about physicians' involvement with pharmaceutical companies spawn contradictory ideas. One set of policies aims to stimulate collaboration between private companies and publicly employed researchers to spur innovation and economic growth, another addresses what is seen as the problem of physicians' conflicts of interest stemming from industry collaboration. This article explores how these contradictory policies interact with everyday practice in clinical hypertension research in Denmark. I argue that 'corporate' and 'academic' research is entangled as physicians participate in industry trials to pursue their own research. Building on document analysis, observations of contract research, and interviews with clinician researchers and industry executives, I show how the establishment of industry 'ties' can serve as a way for physicians to navigate the constraints of research infrastructures and live up to intergenerational norms that knit the medical collective together. I discuss how this entanglement shapes medical research in ways that may run counter to the aims of medical innovation policies and that conflicts of interest policies do little to address. I conclude that appreciation of the ways in which economic and moral valuations come together is necessary to understand the conditions for medical research in an intertwined public-private research environment.

Infrastructuring precision medicine: Making gene therapies for rare diseases workable in practice.

Long viewed by social scientists as a future imaginary, precision medicine is now materializing in many healthcare systems in the form of new diagnostic practices and novel treatment modalities, such as gene therapies. Based on an ethnographic study of the introduction of the first two clinically available in-vivo gene therapies in the Danish healthcare system, we investigate what it takes to make these therapies workable in practice. Drawing on social science literature on infrastructuring, we describe the many forms of mundane work required to fit these therapies into regulatory frameworks, political processes and daily work practices in the healthcare system. Further, we observe how the processes of infrastructuring required to introduce the gene therapies into clinical practice had transformative implications as they redistributed roles and responsibilities among clinicians, pharmacists, procurement agencies and pharmaceutical manufacturers.

The life and death of confidentiality: a historical analysis of the flows of patient information.

Health data can contain sensitive information. People who consult a doctor seek help on issues that matter to them: they typically expect some form of confidentiality. However, the notion and practices of confidentiality have changed dramatically over time. In this article, we trace the history of confidentiality in the Danish healthcare system, which has one of the world's most integrated patient information infrastructures. Building on an analysis of legal and political documents dating back to the late seventeenth century, we show that confidentiality originated as a social phenomenon that helped build trust in healthcare professionals and gradually developed into an idiom of citizens rights. Lately, confidentiality has given way to more technocratic forms of data protection. As the political, legal and technological reality, which the idea of confidentiality once referred to, has radically changed, we argue that confidentiality has become what Ulrik Beck has called a 'zombie category'-a notion that lives on even if its content has passed away. If confidentiality has become a zombie concept, we suggest it is time to discuss what may take its place so that patient interests are protected in the current political economy of health data.

Patient participation in priority setting: Co-existing participant roles.

Reflecting a 'participatory turn' in healthcare, a variety of activities have been adopted in many countries to harness the views of patients, relatives and service users. While celebrated as a way of empowering patients and increasing the legitimacy of decisions that impact on patient care, critics contend that practices of patient participation often fall short of the ideals they purport to implement. In this article, we investigate how patients' participation in medical priority setting corresponds with the regulative ideals of deliberation and how the practices of participation influence the ability of patients to make their voices heard. Building on document analysis and semi-structured interviews with 12 patient representatives and four scientific officers in the Danish Medicines Council, the analysis demonstrates that conflicting notions of valid knowledge constituted a main challenge for patient participation. The study contributes to the literature on patient participation through a conceptualization of four co-existing participant roles: 1) compliant keepers of experiential knowledge, 2) lay experts investing in evidence production, 3) knowledge translators engaged in alliance building, and 4) demonstrators promoting public contestation. We suggest that a main challenge for PP initiatives is to take into account this variation in patients' engagement.

National clinical guidelines and treatment centralization do not guarantee consistency in healthcare delivery. A mixed-methods study of wet age-related macular degeneration treatment in Denmark.

As clinical practice variation has been problematized as a symptom of suboptimal care and inefficient resource spending, consistency in the delivery of healthcare is a recurring policy goal. We examine a case where the introduction of a new treatment is most likely to provide consistency in healthcare delivery because it was introduced with a national clinical practice guideline representing consensus about best clinical practice among leading clinicians, and because care delivery was highly centralized to few high-volume treatment units. Despite the consensus on best clinical practice and care centralization, this study shows pronounced regional variation in patient outcomes and treatment costs that increased over time. Using a mixed-methods design, we find that the lack of consistency in care was largely unrelated to patient-specific characteristics, but seemed to reflect structural differences in the regional organization and financing of healthcare delivery. We conclude that the value of clinical practice guidelines is undermined when structural barriers limit the ability of clinicians and clinical managers to scale up treatment, and that some degree of decentralization may be a tool to maintain treatment intensity when the treatment effect is dependent on a high treatment intensity.

Strategies of stratification: Regulating market access in the era of personalized medicine.

Personalized medicine raises the stakes of pharmaceutical market regulation. Drawing on pragmatist valuation studies and science and technology studies literature on personalized medicine and pharmaceutical markets, this article demonstrates how complex negotiations about the value of a pharmaceutical can constitute a market in various ways, while also shaping the concerned patient populations. Tracing the path of a pharmacogenetic treatment, Spinraza, from its approval by the European Medicines Agency to its adoption in the publicly funded Danish healthcare system, we show how the market was formatted through particular stratifications of the patient population. We conceptualize these seemingly technical moves as strategies of stratification, that is, the application of techniques to assemble and divide data - and what data are meant to represent - into groups delineated by certain characteristics. We argue that stakeholders' use of strategies of stratification has important implications not only for market access, but also for the delineation of diseases and patient populations. Hence, it is crucial to make intelligible the mutual constitution of pharmaceutical markets and patient populations and the political efforts of delineating and connecting the two.

[Use of real-world evidence in regulatory drug approval].

Real-world evidence (RWE) is gaining traction in political and scientific debate. The RWE debate revitalises discussions about causal inference by challenging the randomised controlled trial as a gold standard for demonstrating drug efficacy and effectiveness. This article outlines methodological challenges and possibilities for using RWE in regulatory drug approval. We argue, that more precise terminology and methodological considerations about study designs and data quality is needed, if the RWE debate is to inform new standards for evidence-based decision-making.

New model for prioritised adoption and use of hospital medicine in Denmark since 2017: Challenges and perspectives.

Technological innovation creates new treatment opportunities, while also putting healthcare budgets under strain. To deal with the rising costs of hospital medicines, the regional governments in Denmark have developed a new model for prioritising the adoption and use of hospital medicine. Marking a shift from previous policies, the new model formalises the evaluation of clinical benefit, adds an assessment of treatment costs and ensures a relatively high degree of direct stakeholder involvement. In international comparison, the new model is ambitious in terms of stakeholder involvement and adherence with principles advocated to ensure procedural justice and fair decision-making processes. However, these procedural innovations have also created new challenges. Notably, the newly formed assessment body, the Danish Medicines Council, is faced with a very high caseload and limited options to prioritise the use of its analytical resources.

A review of attitudes towards the reuse of health data among people in the European Union: The primacy of purpose and the common good.

Health data are used for still more purposes, and policies are enacted to facilitate data reuse within the European Union. This literature synthesis explores attitudes among people living in the European Union towards the use of health data for purposes other than treatment. Our findings indicate that while a majority hold positive attitudes towards the use of health data for multiple purposes, the positive attitudes are typically conditional on the expectation that data will be used to further the common good. Concerns evolve around the commercialisation of data, data security and the use of data against the interests of the people providing the data. Studies of these issues are limited geographically as well as in scope. We therefore identify a need for cross-national exploration of attitudes among people living in the European Union to inform future policies in health data governance.

[Clinical trial informed consent information for participants can be improved].

Informed consent has been a legal right for patients participating in clinical research and an obligation for health professionals for a long time. A growing body of literature suggests that a considerable share of research participants do not read or understand the information they are given, or do not base their decisions on trial participation on the information. This article points out the challenges for health professionals arising from this situation and offers suggestions for how professionals can deal with the challenges.

Rationalising prescribing: Evidence, marketing and practice-relevant knowledge.

Initiatives in the name of 'rational pharmacotherapy' have been launched to alter what is seen as 'inappropriate' prescribing practices of physicians. Based on observations and interviews with 20 general practitioners (GPs) in 2009-2011, we explored how attempts to rationalise prescribing interact with chronic care management in Denmark. We demonstrate how attempts to rationalise prescribing by informing GPs about drug effects, adverse effects and price do not satisfy GPs' knowledge needs. We argue that, for GPs, 'rational' prescribing cannot be understood in separation from the processes that enable patients to use medication. Therefore, GPs do much more to obtain knowledge about medications than seek advice on 'rational pharmacotherapy'. For instance, GPs also seek opportunities to acquaint themselves with the material objects of medication and medical devices. We conceptualise the knowledge needs of GPs as a need for practice-relevant knowledge and argue that industry sales representatives are granted opportunity to access general practice because they understand this need of GPs.

Analytical perspectives on performance-based management: an outline of theoretical assumptions in the existing literature.

Performance-based management (PBM) has become a dominant form of governance in health care and there is a need for careful assessment of its function and effects. This article contains a cross-disciplinary literature synthesis of current studies of PBM. Literature was retrieved by database searches and categorized according to analytical differences and similarities concerning (1) purpose and (2) governance mechanism of PBM. The literature could be grouped into three approaches to the study of PBM, which we termed: the 'functionalist', the 'interpretive' and the 'post-modern' perspective. In the functionalist perspective, PBM is perceived as a management tool aimed at improving health care services by means of market-based mechanisms. In the interpretive perspective, the adoption of PBM is understood as consequence of institutional and individual agents striving for public legitimacy. In the post-modern perspective, PBM is analysed as a form of governance, which has become so ingrained in Western culture that health care professionals internalize and understand their own behaviour and goals according to the values expressed in these governance systems. The recognition of differences in analytical perspectives allows appreciation of otherwise implicit assumptions and potential implications of PBM. Reflections on such differences are important to ensure vigilant appropriation of shifting management tools in health quality governance.

Coordination between primary and secondary healthcare in Denmark and Sweden.

INTRODUCTION: Insights into effective policy strategies for improved coordination of care is needed. In this study we describe and compare the policy strategies chosen in Denmark and Sweden, and discuss them in relation to interorganisational network theory. POLICY PRACTICE: The policy initiatives to improve collaboration between primary and secondary healthcare in Denmark and Sweden include legislation and agreements aiming at clarifying areas of responsibility and defining requirements, creation of links across organisational boarders. In Denmark many initiatives have been centrally induced, while development of local solutions is more prominent in Sweden. Many Danish initiatives target the administrative level, while in Sweden initiatives are also directed at the operational level. In both countries economic incentives for collaboration are weak or lacking, and use of sanctions as a regulatory mean is limited. DISCUSSION AND CONCLUSION: Despite a variety of policy initiatives, lacking or poorly developed structures to support implementation function as barriers for coordination. The two cases illustrate that even in two relatively coherent health systems, with regional management of both the hospital and general practice sector, there are issues to resolve in regard to administrative and operational coordination. The interorganisational network literature can provide useful tools and concepts for interpreting such issues.