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.

Interventions supporting cancer patients in making decisions regarding participation in clinical trials - a systematic review.

OBJECTIVES: Existing research on the perspectives of patients with cancer and health care professionals indicates that patient decision making on cancer clinical trial participation is a complex process and may be poorly understood, possibly compromising their decision to participate. This systematic review investigates interventions that support patients in their decision-making processes regarding whether to participate or not and assesses the qualities of the interventions, measures used and related outcomes. METHODS: Six databases were systematically searched and only studies evaluating interventions that support the decision making of adult patients offered to enter a cancer clinical trial were included. Ten articles met the criteria and were analysed using a narrative synthesis approach. RESULTS: The research focus of the included studies reflected the multifactorial nature of what constitutes support for patient decision making in terms of entering a cancer clinical trial. However, most interventions were based on the hypothesis that more information leads to support in decision making, and did not take other factors, such as the relationship to the clinical staff or relatives, the patients' strong hope for therapeutic benefit or other existential needs into account. The interventions were primarily based on a specific tool, executed once, which seems to imply that decisions need only to be supported once and not at several time points throughout the decision process, and did not assess the importance of a patient's family- or social relations. Moreover, few interventions focused on the patients' counselling experience or assessed patient preferences in relation to decision making. CONCLUSIONS: The findings demonstrate a lack of research on interventions to support patients' decision making that takes other factors, apart from improving knowledge of trials, into account. Limited evidence exists on the effectiveness of decision support interventions to improve the experience of support in adult patients with cancer. Interventions that take patient preferences in relation to decision making and the social context of decision processes into account need to be developed and assessed.

Precision patients: Selection practices and moral pathfinding in experimental oncology.

This paper addresses selection practices in a Danish phase 1 unit specialised in precision medicine in the field of oncology. Where precision medicine holds the ambition of selecting genetically fit medicine for the patient, we find that precision medicine in the early trial setting is oriented towards selecting clinically and genetically fit patients for available treatment protocols. Investigating how phase 1 oncologists experience and respond to the moral challenges of selecting patients for early clinical trials, we show that inclusion criteria and patient categories are not always transparent to patients. Lack of transparency about inclusion criteria has been interpreted as morally problematic. Yet drawing on social science studies of 'unknowing', we argue that silence and non-transparency in interactions between oncologists and patients are crucial to respect the moral agency of patients at the edge of life and recognise them as belonging to the public of Danish health care. In the discussion, we consider the practice of placing 'unfit' patients on a waiting list for trial participation. Rather than representing an ethical and political problem, we argue, the waiting list can act as a valve enabling oncologists to navigate the scientific and as well as the moral uncertainties in phase 1 oncology.

Co-creating with families and healthcare professionals: shaping a context-sensitive health promotion intervention 'Face-it'.

Participatory methodologies have become imperative when developing health promotion programmes. However, the concrete adoption of co-creation and its implications for intervention development are less reported. This article aims to convey how fidelity and adaptation were balanced in a structured intervention design by co-creating intervention components with various stakeholders. The intervention was part of the Face-it programme, which was initiated to prevent diabetes and increase the quality of life in women with prior diabetes during pregnancy by supporting the entire family's health practices. We relied on participatory methods, e.g. workshops using design games, role play and family interviews, as well as ethnographic fieldwork. Stakeholders comprised women with prior gestational diabetes mellitus and their families as intervention receivers and healthcare professionals, e.g. obstetricians, midwives and health visitors as potential intervention deliverers to shape intervention content. We used Bammer's stakeholder participation spectrum in research to describe how different stakeholders were engaged and with what implications for the intervention components. This article shows how an iterative co-creation process was (i) achieved through diverse involvement practices across stakeholder groups; and (ii) upheld both premises of the structured design (fidelity) and flexibility (adaptation) in developing intervention content and delivery. When adopting co-creation as a strategy for intervention development, we recommend using various engagement practices according to the role of stakeholders in the intervention and available resources to create ownership and sustainable intervention content.

This article argues that by involving stakeholders in intervention development differently according to their available resources, and intervention roles, we can optimize co-creation processes and thus increase the likelihood of intervention sustainability. We describe how co-creation was pursued by involving multiple stakeholders comprising: families where the mother previously had a pregnancy-related diabetes (target group); healthcare professionals working with women with diabetes in pregnancy, including health visitors (intervention deliverers). We engaged in co-creation through workshops using design games, in-depth interviews and ethnographic fieldwork to understand families' experiences with gestational diabetes and how these experiences can be used to facilitate health practices after birth. Also, we negotiated intervention content and delivery with health visitors, which optimized feedback processes to adapt intervention content and strengthened the health visitors' ownership towards delivering the intervention as intended. By using Bammer's stakeholder-participation-spectrum in research, we show how we tailored co-creation to the target group, intervention deliverers and other key stakeholders in intervention development. Further, we suggest collaborating and empowering intervention deliverers as part of the solution in balancing the underlying premises of a structured design with the social dynamics learned from the intervention deliverers and the target group.

Systematically developing a family-based health promotion intervention for women with prior gestational diabetes based on evidence, theory and co-production: the Face-it study.

BACKGROUND: Women with prior gestational diabetes mellitus (GDM) are at high risk of developing type 2 diabetes; however, this risk can be reduced by engaging in positive health behaviours e.g. healthy diet and regular physical activity. As such behaviours are difficult to obtain and maintain there is a need to develop sustainable behavioural interventions following GDM. We aimed to report the process of systematically developing a health promotion intervention to increase quality of life and reduce diabetes risk among women with prior GDM and their families. We distil general lessons about developing complex interventions through co-production and discuss our extensions to intervention development frameworks. METHODS: The development process draws on the Medical Research Council UK Development of complex interventions in primary care framework and an adaptation of a three-stage framework proposed by Hawkins et al. From May 2017 to May 2019, we iteratively developed the Face-it intervention in four stages: 1) Evidence review, qualitative research and stakeholder consultations; 2) Co-production of the intervention content; 3) Prototyping, feasibility- and pilot-testing and 4) Core outcome development. In all stages, we involved stakeholders from three study sites. RESULTS: During stage 1, we identified the target areas for health promotion in families where the mother had prior GDM, including applying a broad understanding of health and a multilevel and multi-determinant approach. We pinpointed municipal health visitors as deliverers and the potential of using digital technology. In stage 2, we tested intervention content and delivery methods. A health pedagogic dialogue tool and a digital health app were co-adapted as the main intervention components. In stage 3, the intervention content and delivery were further adapted in the local context of the three study sites. Suggestions for intervention manuals were refined to optimise flexibility, delivery, sequencing of activities and from this, specific training manuals were developed. Finally, at stage 4, all stakeholders were involved in developing realistic and relevant evaluation outcomes. CONCLUSIONS: This comprehensive description of the development of the Face-it intervention provides an example of how to co-produce and prototype a complex intervention balancing evidence and local conditions. The thorough, four-stage development is expected to create ownership and feasibility among intervention participants, deliverers and local stakeholders. TRIAL REGISTRATION: ClinicalTrials.gov NCT03997773 , registered retrospectively on 25 June 2019.

Aging biomarkers and the measurement of health and risk.

Prevention of age-related disorders is increasingly in focus of health policies, and it is hoped that early intervention on processes of deterioration can promote healthier and longer lives. New opportunities to slow down the aging process are emerging with new fields such as personalized nutrition. Data-intensive research has the potential to improve the precision of existing risk factors, e.g., to replace coarse-grained markers such as blood cholesterol with more detailed multivariate biomarkers. In this paper, we follow an attempt to develop a new aging biomarker. The vision among the project consortium, comprising both research and industrial partners, is that the new biomarker will be predictive of a range of age-related conditions, which may be preventable through personalized nutrition. We combine philosophical analysis and ethnographic fieldwork to explore the possibilities and challenges of managing aging through bodily signs that are not straightforwardly linked to symptomatic disease. We document how the improvement of measurement brings about new conceptual challenges of demarcating healthy and unhealthy states. Moreover, we highlight that the reframing of aging as risk has social and ethical implications, as it is generative of normative notions of what constitutes successful aging and good citizenship.

Changing tastes: learning hunger and fullness after gastric bypass surgery.

Gastric bypass surgery is a specific medical technology that alters the body in ways that force patients to fundamentally change their eating habits. When patients enrol for surgery, they enter a learning process, encountering new and at times contested ways of sensing their bodies, tasting, and experiencing hunger and fullness. In this paper, we explore how patients begin to eat again after gastric bypass surgery. The empirical data used here are drawn from a Danish fieldwork study of individuals undergoing obesity surgery. The material presented shows how the patients used instructions on how to eat. We explore the ways in which diverse new experiences and practices of hunger and fullness are part of the process of undergoing surgery for severe obesity. New sensory experiences lead to uncertainty; as a result, patients practice what we term mimetic eating, which reflects a 'sensory displacement' and hence a rupture in the person's sense of self and social relations. We suggest that eating should be conceptualised as a practice that extends beyond the boundaries of our bodies and into diverse realms of relations and practices, and that changing the way we eat also changes the fundamentally embodied experience of who we are.

Working with a fractional object: enactments of appetite in interdisciplinary work in anthropology and biomedicine.

This paper explores the productive tensions occurring in an interdisciplinary research project on weight loss after obesity surgery. The study was a bio-medical/anthropological collaboration investigating to what extent eating patterns, the subjective experience of hunger and physiological mechanisms are involved in appetite regulation that might determine good or poor response to the surgery. Linking biomedical and anthropological categories and definitions of central concepts about the body turned out to be a major challenge in the collaborative analysis. Notably, the conception of what constitutes 'appetite' was a key concern, as each discipline has its particular definition and operationalization of the term. In response, a material-semiotic approach was chosen which allowed for a reconceptualization of appetite as a 'fractional object', engaged in multiple relations and enacted differently in each instance. This perspective produced creative contrasts and offered alternative explorations of both scientific knowledge production and anthropological practices. The paper thereby explores the interfaces between anthropology and medical science by attending to the challenges and opportunities that result from destabilising an assumed fixed and well-defined concept associated with the body.

Protocol for a randomised controlled trial of a co-produced, complex, health promotion intervention for women with prior gestational diabetes and their families: the Face-it study.

BACKGROUND: Gestational diabetes mellitus (GDM) is associated with an increased risk of future diabetes in both mother, father and offspring. More knowledge is needed about how to effectively reduce the risk of diabetes through sustained behavioural interventions in these families. The Face-it intervention is a complex health promotion intervention embedded in multi-level supportive environments. The aim of the intervention is to reduce type 2 diabetes risk and increase quality of life among families in the first year following a GDM-affected pregnancy by promoting physical activity, healthy dietary behaviours and breastfeeding through a focus on social support, motivation, self-efficacy, risk perception and health literacy. METHODS: This national multicentre study is a two-arm randomised controlled trial including 460 women with GDM in a ratio of 2 (intervention):1 (usual care). The Face-it intervention consists of three main components: 1) additional visits from municipal health visitors, 2) digital health coaching tailored to family needs and 3) a structured cross-sectoral communication system in the health care system. The intervention runs from 3 to 12 months after delivery. The primary outcome is maternal body mass index at 12 months after delivery as a proxy for diabetes risk. The women will be examined at baseline and at follow-up, and this examination will include blood tests, oral glucose tolerance test (OGTT), anthropometrics, blood pressure, self-reported diet and physical activity, breastfeeding, quality of life, health literacy, physical and mental health status, risk perception and social support. Aside from those data collected for OGTT and breastfeeding and offspring parameters, the same data will be collected for partners. Data on offspring anthropometry will also be collected. Information on pregnancy- and birth-related outcomes will be derived from the medical records of the woman and child. DISCUSSION: This randomised controlled trial seeks to demonstrate whether the Face-it intervention, addressing the individual, family and health care system levels, is superior to usual care in reducing diabetes risk for mothers and their families. Coupled with a process evaluation and an economic analysis, the study will provide evidence for policymakers and health services about health promotion among families affected by GDM and the potential for reducing risk of type 2 diabetes and associated conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03997773. Registered June 25, 2019 - Retrospectively registered.

Identifying notions of environment in obesity research using a mixed-methods approach.

The recent rise of computation-based methods in social science has opened new opportunities for exploring qualitative questions through analysis of large amounts of text. This article uses a mixed-methods design that incorporates machine reading, network analysis, semantic analysis, and qualitative analysis of 414 highly cited publications on obesogenic environments between 2001 and 2015. The method produces an elaborate network map exhibiting five distinct notions of environment, all of which are currently active in the field of obesity research. The five notions are institutional, built, food, family, and bodily environments. The network map is proposed as a navigational tool both for policy actors who wish to coordinate efforts between a variety of stakeholders and for researchers who wish to understand their own research and research plans in light of different positions in the field. The final part of the article explores how the network map may also initiate a broader set of reflections on the configuration, differentiation, and coherence of the field of obesity research.