Viden, værdi og omstridt ekspertise: Analyse af den danske debat om lægemiddelprioritering

This article explores an ongoing attempt to introduce health economic evaluation in the assessment of newly marketed pharmaceuticals in Denmark. Drawing on valuation theory from the field of science and technology studies (STS), the purpose is to analyse how various conceptions of value interact in the public debate, and how it shapes the political solutions. Building on document analysis, the article shows how actors in the debate express contrasting conceptions of what constitutes relevant expertise, proper mechanisms of resource allocation and a legitimate basis for political decisions. In an attempt to accommodate the dissonance, the resulting decision-model has introduced new challenges for the health authorities to deal with. In particular, a somewhat paradoxical situation has arisen where evaluation institutions are required to undertake evaluations of treatment costs – but without the option of using well-established health economic methods to judge the cost-effectiveness. Hence, evaluation institutions are left with the challenge of how to operationalise the decision-model

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

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

Hidden in the Middle : Culture, Value and Reward in Bioinformatics

Bioinformatics - the so-called shotgun marriage between biology and computer science - is an interdiscipline. Despite interdisciplinarity being seen as a virtue, for having the capacity to solve complex problems and foster innovation, it has the potential to place projects and people in anomalous categories. For example, valorised 'outputs' in academia are often defined and rewarded by discipline. Bioinformatics, as an interdisciplinary bricolage, incorporates experts from various disciplinary cultures with their own distinct ways of working. Perceived problems of interdisciplinarity include difficulties of making explicit knowledge that is practical, theoretical, or cognitive. But successful interdisciplinary research also depends on an understanding of disciplinary cultures and value systems, often only tacitly understood by members of the communities in question. In bioinformatics, the 'parent' disciplines have different value systems; for example, what is considered worthwhile research by computer scientists can be thought of as trivial by biologists, and vice versa. This paper concentrates on the problems of reward and recognition described by scientists working in academic bioinformatics in the United Kingdom. We highlight problems that are a consequence of its cross-cultural make-up, recognising that the mismatches in knowledge in this borderland take place not just at the level of the practical, theoretical, or epistemological, but also at the cultural level too. The trend in big, interdisciplinary science is towards multiple authors on a single paper; in bioinformatics this has created hybrid or fractional scientists who find they are being positioned not just in-between established disciplines but also in-between as middle authors or, worse still, left off papers altogether

Informeret samtykke i kliniske forsøg: teknikaliteter, tillid og tætte relationer

I denne artikel undersøges kroniske patienters beslutninger om forsøgsdeltagelse og betydningen af deltagerinformation. På baggrund af et års feltarbejde på fire danske forskningsklinikker argumenterer jeg for, at de observerede patienter opererer efter andre logikker, når de tager beslutninger om at deltage i kliniske forsøg, end hvad der antages i den gældende forskningsetiske regulering. Feltarbejdet fulgte et klinisk lægemiddelforsøg og inkluderede observationer af forsøgskonsultationer; interviews med investigatorer, projektsygeplejersker, forsøgsdeltagere og virksomhedsrepræsentanter; samt en mindre spørgeskemaundersøgelse blandt de danske forsøgsdeltagere. Resultaterne indikerer, at for en gruppe af erfarne forsøgsdeltagere handler beslutningerne om forsøgsdeltagelse ikke om forsøget i sig selv, men om at opretholde en nær relation til forskningspersonalet. Disse patienter orienterer sig ikke efter deltagerinformation, men i forhold til tillidsrelationer. De agerer ikke som autonome individer, men oplever, at de er afhængige af sundhedssystemet. De udtrykker altruistiske motiver, men håber samtidig, at forsøgsdeltagelse vil give dem bedre helbredskontrol. For dem er forsøgsdeltagelse blevet en måde at leve med kronisk sygdom. Mulige implikationer af denne situation diskuteres, idet det understreges, at tillidsfulde relationer er en forudsætning både for god behandling og god forskning, men at de tætte relationer samtidig kan bevirke, at patienter bliver mindre kritiske, i forhold til hvilke forsøg de accepterer at deltage i, og at en bevidsthed om forsøgsrelaterede risici fortrænges fra forsøgssituationen. Nøgleord: informeret samtykke, deltagerinformation, deltagermotivation, kliniske forsøg, kronisk sygdom, Danmark English summary: Informed consent in clinical trials: technicalities, trust and intimate relationships This article explores decisions about clinical trial participation in a group of patients with chronic conditions, focusing especially on motivation for trial participation and trial information. Based on ethnographic research in four Danish hospitals in conjunction with a clinical drug trial, I argue that these patients’ decisions follow logics other than those anticipated in research ethics regulations. I build on observations, interviews with physician-investigators, project nurses, patient-participants and trial sponsors, and a survey of the participants. The results indicate that for a group of experienced trial participants, trial information plays a very limited role because their decisions do not concern the trial per se but the sustainment of a close relationship with the research staff. They do not act as autonomous individuals weighing pros and cons based on the written information they receive. Rather, they feel dependent on the healthcare system and navigate in trust relations. For them, trial participation has become a way of living with chronic disease. I discuss implications of this situation underlining that trustful relationships constitute a precondition for high quality chronic care and research, yet the social dynamics may also lead patients to pay less attention to risks associated with trial participation