'Matters-of-concern' associated with discontinuation of long-acting injectable buprenorphine: Findings from a longitudinal qualitative study.

BACKGROUND: Discontinuation of medications such as methadone and buprenorphine amongst patients receiving opioid agonist treatment (OAT) is an international phenomenon. Recent developments in OAT medication include depot-injections of buprenorphine. Circumstances underlying discontinuation of these new formulations of medication are not fully understood from a qualitative perspective. METHODS: Data derive from a longitudinal qualitative study of patients' experience of long-acting injectable buprenorphine (LAIB), involving semi-structured telephone-interviews held at six-points in time. The relevant dataset for this article consists of 44 interview transcripts, generated from 8 participants who were each affected by discontinuation of LAIB prescriptions (during the first 12-months of treatment). Analyses sought to identify circumstances associated with LAIB discontinuation and data were further situated within a framework of 'evidence making intervention' and associated 'matters-of-concern'. Matters-of-concern relate to the ways in which an intervention is 'made' and constructed through engagement and practice, from the perspective of the recipient. FINDINGS: In this study, participants experienced either 'discontinuation of LAIB prescriptions by treatment services' or patient-led 'opt-out' from treatment. Matters-of-concern underlying the former were associated with late attendance for scheduled appointments, non-prescribed substance use or receiving a custodial sentence. Matters-of-concern relating to patient-initiated discontinuation were associated with personal circumstances that affected treatment motivation, side-effects (of buprenorphine), a preference to resume heroin use, or because individual treatment goals had been achieved. CONCLUSION: The assorted matters-of-concern that influence discontinuation of LAIB demonstrate that such OAT is complex and multi-faceted, is neither fixed nor stable, and does not generate universally shared outcome. Experiences of LAIB discontinuation are shaped by a wide range of social, temporal and treatment-related effects that include disconnected therapeutic alliance between patient and treatment providers. In order to maximise the benefits of LAIB it is necessary to develop meaningful therapeutic alliances (notwithstanding policy boundaries) to enable exploration of matters-of-concern during treatment.

The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring.

Digital therapeutics (DTx) are a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. However, developing and deploying DTx is inherently complex in that DTx includes multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs that may change over time. While myriad frameworks exist for different phases of DTx development, no single framework exists to guide evidence production for DTx across its full life cycle, from initial DTx development to long-term use. To fill this gap, we propose the DTx real-world evidence (RWE) framework as a pragmatic, iterative, milestone-driven approach for developing DTx. The DTx RWE framework is derived from the 4-phase development model used for behavioral interventions, but it includes key adaptations that are specific to the unique characteristics of DTx. To ensure the highest level of fidelity to the needs of users, the framework also incorporates real-world data (RWD) across the entire life cycle of DTx development and use. The DTx RWE framework is intended for any group interested in developing and deploying DTx in real-world contexts, including those in industry, health care, public health, and academia. Moreover, entities that fund research that supports the development of DTx and agencies that regulate DTx might find the DTx RWE framework useful as they endeavor to improve how DTxcan advance individual and population health.

The multiple makings of a supervised consumption service in a hospital setting.

BACKGROUND: Whereas supervised consumption services (SCSs) are common in many community settings, they are seldomly found in acute care hospitals. As hospitals present unique circumstances that can shape the impacts of an SCS, careful consideration of local implementation contexts and practices is required. We explored the pre-implementation stage of an SCS, to examine how an SCS is made and made differently in relation to the material-discursive context of the hospital. METHODS: We conducted 11 focus groups with 83 staff and clinicians at an inner-city hospital in Toronto, Canada. Data analysis followed principles of grounded theory and was informed by an 'evidence making interventions' framework. RESULTS: While most participants indicated they would support the establishment of an SCS at the hospital, multiple enactments of an SCS emerged. An SCS was enacted: as a means to reduce drug-related risks for all people who use drugs, as an opportunity to intervene on patients' drug use, as a means to centralize drug use, and as a transformative intervention for the hospital. In our findings, harm reduction, abstinence, security, and risk mitigation goals existed closely together, yielding overlaying realities. CONCLUSION: Our findings revealed various enactments of an SCS, some of which are likely to negatively affect people who use drugs and service access. As more hospitals consider the implementation of an SCS, understanding how an SCS is made in practice will be key to building a service that focuses on the needs of people who use drugs.

"A matter of time": Evidence-making temporalities of vaccine development in the COVID-19 media landscape.

This article investigates how evidence of the safety and efficacy of COVID-19 vaccines is enacted in news media via a focus on the temporality of vaccine development. We argue that time constitutes a crucial object of and mechanism for knowledge production in such media and investigate how time comes to matter in vaccine evidence-making communication practices. In science communication on vaccine development, the vaccine object (along with the practices through which it is produced) undergoes a material-discursive shift from an imagined "rushed" product to being many years in the making and uninhibited by unnecessarily lengthy processes. In both these enactments of vaccine development, time itself is constituted as evidence of vaccine efficacy and safety. This article traces how time (performed as both calendar time and as a series of relational events) is materialized as an affective and epistemic object of evidence within public science communication by analyzing the material-discursive techniques through which temporality is enacted within news media focused on the timeline of COVID-19 vaccine development. We contend that time (as evidence) is remade through these techniques as an ontopolitical concern within the COVID-19 vaccine assemblage. We furthermore argue that science communication itself is an important actor in the hinterland of public health practices with performative effects and vital evidence-making capacities.

Making pandemics big: On the situational performance of Covid-19 mathematical models.

In this paper, we trace how mathematical models are made 'evidence enough' and 'useful for policy'. Working with the interview accounts of mathematical modellers and other scientists engaged in the UK Covid-19 response, we focus on two weeks in March 2020 prior to the announcement of an unprecedented national lockdown. A key thread in our analysis is how pandemics are made 'big'. We follow the work of one particular device, that of modelled 'doubling-time'. By following how modelled doubling-time entangles in its assemblage of evidence-making, we draw attention to multiple actors, including beyond models and metrics, which affect how evidence is performed in relation to the scale of epidemic and its policy response. We draw attention to: policy; Government scientific advice infrastructure; time; uncertainty; and leaps of faith. The 'bigness' of the pandemic, and its evidencing, is situated in social and affective practices, in which uncertainty and dis-ease are inseparable from calculus. This materialises modelling in policy as an 'uncomfortable science'. We argue that situational fit in-the-moment is at least as important as empirical fit when attending to what models perform in policy.

New directions for participatory modelling in health: Redistributing expertise in relation to localised matters of concern.

Participatory modelling seeks to foster stakeholder engagement to better attune models to their decision-making and policy contexts. Such approaches are increasingly advocated for use in the field of health. We review the instrumental and epistemological claims made in support of participatory modelling approaches. These accentuate participatory models as offering a better evidence-base for health policy decisions. By drawing attention to recent modelling experiments in a sector outside of health, that of water management, we outline a different way of thinking about participation and modelling. Here, the participatory model is configured in relation to matters of 'knowledge controversy', with modelling constituted as an 'evidence-making intervention' in relation to the making of science and expertise. Rather than presenting participatory models as an improved technical solution to addressing given policy problems within an evidence-based intervention approach, models are alternatively potentiated as sites for the redistribution of expertise among actor networks as they seek to engage politically in a matter of concern. This leads us to consider possible new directions for participatory modelling in the field of health.

How to think with models and targets: Hepatitis C elimination as a numbering performance.

The field of public health is replete with mathematical models and numerical targets. In the case of disease eliminations, modelled projections and targets play a key role in evidencing elimination futures and in shaping actions in relation to these. Drawing on ideas within science and technology studies, we take hepatitis C elimination as a case for reflecting on how to think with mathematical models and numerical targets as 'performative actors' in evidence-making. We focus specifically on the emergence of 'treatment-as-prevention' as a means to trace the social and material effects that models and targets make, including beyond science. We also focus on how enumerations are made locally in their methods and events of production. We trace the work that models and targets do in relation to three analytical themes: governing; affecting; and enacting. This allows us to situate models and targets as technologies of governance in the constitution of health, which affect and are affected by their material relations, including in relation to matters-of-concern which extend beyond calculus. By emphasising models and targets as enactments, we draw attention to how these devices give life to new enumerated entities, which detach from their calculative origins and take flight in new ways. We make this analysis for two reasons: first, as a call to bring the social and enumeration sciences closer together to speculate on how we might think with models and targets differently and more carefully; and second, to encourage an approach to science which treats evidencing-making interventions, such as models and targets, as performative and political.

What prevents health policy being 'evidence-based'? New ways to think about evidence, policy and interventions in health.

BACKGROUND: Evidence-based policy decision-making is a dominant paradigm in health but realizing this ideal has proven challenging. SOURCES OF DATA: This paper conceptually maps health policy, policy studies and social science literature critically engaged with evidence and decision-making. No new data were generated or analysed in support of this review. AREAS OF AGREEMENT: Barriers to evidence-based policy have been documented, with efforts made to increase the uptake of evidence. AREAS OF CONTROVERSY: Evident complexities have been regarded as a problem of translation. However, this assumes that policy-making is a process of authoritative choice, and that 'evidence' is inherently valuable policy knowledge, which has been critiqued. GROWING POINTS: Alternative accounts urge consideration of how evidence comes to bear on decisions made within complex systems, and what counts as evidence. AREAS TIMELY FOR DEVELOPING RESEARCH: An 'evidence-making intervention' approach offers a framework for conceptualizing how evidence and interventions are made relationally in practices, thus working with the politics and contingencies of implementation and policy-making.

Mathematical models as public troubles in COVID-19 infection control: following the numbers.

Mathematical models are key actors in policy and public responses to the COVID-19 pandemic. The projections from COVID-19 models travel beyond science into policy decisions and social life. Treating models as 'boundary objects', and focusing on media and public communications, we 'follow the numbers' to trace the social life of key projections from prominent mathematical models of COVID-19. Public deliberations and controversies about models and their projections are illuminating. These help trace how projections are 'made multiple' in their enactments as 'public troubles'. We need an approach to evidence-making for policy which is emergent and adaptive, and which treats science as an entangled effect of public concern made in social practices. We offer a rapid sociological response on the social life of science in the emerging COVID-19 pandemic to speculate on how evidence-making might be done differently going forwards.

The becoming-methadone-body: on the onto-politics of health intervention translations.

In this paper, we reflect on health intervention translations as matters of their implementation practices. Our case is methadone treatment, an intervention promoted globally for treating opioid dependence and preventing HIV among people who inject drugs. Tracing methadone's translations in high-security prisons in the Kyrgyz Republic, we notice the multiple methadones made possible, what these afford, and the onto-political effects they make. We work with the idea of the 'becoming-methadone-body' to trace the making-up of methadone treatment and its effects as an intra-action of human and nonhuman substances and bodies. Methadone's embodied effects flow beyond the mere psycho-activity of substances incorporating individual bodies, to material highs and lows incorporating the governing practices of prisoner society. The methadone-in-practice of prisoner society is altogether different to that imagined as being in translation as an intervention of HIV prevention and opioid treatment, and has material agency as a practice of societal governance. Heroin also emerges as an actor in these relations. Our analysis troubles practices of 'evidence-based' intervention and 'implementation science' in the health field, by arguing for a move towards 'evidence-making' intervention approaches. Noticing the onto-politics of health intervention translations invites speculation on how intervening might be done differently.

Evidence-making hepatitis C cure: Towards a science that knows more carefully.

There has been some controversy concerning the curative potential of new treatments for hepatitis C. This follows a systematic review of the Cochrane Collaboration questioning the clinical benefits of direct-acting antivirals (DAAs). This controversy has been debated as a matter of methods regarding how best to evidence treatment in an evidence-based medicine (EBM) approach. Drawing from science and technology studies (STS), we offer an alternative perspective. We propose a different way of thinking with evidence; one which treats 'evidencing as performative'. Using the Cochrane review and its linked published responses as a resource for this analysis, we consider how hepatitis C cure is differently made-up through the knowledge-making practices performing it. We show how matters of apparent fact in evidence-based science are enacted as matters of clinical, social and ethico-political concern. We notice hepatitis C cure as a fluid object in negotiation. We highlight the limits of current debate to advocate a more critical and careful practice-based approach to knowing hepatitis C cure. This calls upon public health researchers to reflect on the performative work of their evidencing. We propose a 'more-than' EBM approach which treats 'evidence-based' science as an 'evidence-making intervention'. We consider the implications of such an approach for the evidencing of public health interventions and for treating hepatitis C in the DAA era of 'viral elimination'.

"A more accurate understanding of drug use": A critical analysis of wastewater analysis technology for drug policy.

The idea of identifying and monitoring urinary excretion of illicit drugs and their metabolites in wastewater has been seen by governments and international organisations as 'promising'. It is claimed that such approaches will enable governments to effectively direct resources to priority areas, monitor the progress of demand and supply reduction strategies, as well as identify emerging trends. Drawing on poststructural approaches to policy analysis and insights from science and technology studies, we consider how the technology of wastewater analysis may be seen as a kind of proposal with productive capacity and constitutive effects. Through this analysis, we seek to raise ontopolitical questions about the production of data by interrogating the claims to 'accuracy' promoted in wastewater analysis, and illuminating the assumptions underpinning such pursuits. By taking an approach which sees method as performative rather than as descriptive of a pre-existing reality, we consider how wastewater analysis enacts realities into being in the drugs field. Taking Australia's National Wastewater Drug Monitoring Program as a case example, we argue that wastewater analysis constitutes drug use as measurable, countable and comparable and, in doing so, enacts a homogenous drug using population in a bounded geographical space, with implications for drug policy. Furthermore, the claim to 'accuracy' constitutes people who use drugs as lacking in knowledge and unaware, and relates to a range of practices which work to continually re-produce people who use drugs as criminal, untrustworthy and in need of surveillance. Through this analysis, we seek to generate critical discussion about practices of 'evidence-making', the privileging of 'scientific data' in drug policy processes (especially as it relates to population prevalence of drug use), and the hitherto unexamined effects of wastewater analysis for drug policy.

The becoming of methadone in Kenya: How an intervention's implementation constitutes recovery potential.

This analysis treats the recent introduction of methadone treatment in Kenya as a case of 'evidence-making intervention'. Using 30 qualitative interviews with people in receipt of methadone treatment in Nairobi, Kenya, methadone's becoming is treated as an effect of its narrative and material implementations. The interviews are shown to enact a narrative of methadone recovery potential towards normalcy beyond addiction. Such recovery potential is materialised in practice through social interactions wherein methadone's embodied effects are seen to be believed. Here, the recovering body affects others' recovery potential. In a context of competing claims about methadone's effects, including the circulation of doubt about experimenting with methadone treatment, embodied methadone effect helps moderate the multiverse of methadone knowledge. The material dynamics of methadone treatment delivery also affect its recovery potential, with the methadone queue enacting a rationing of recovery hope. Here, the experience of methadone's implementation loops back to a life with drugs. I conclude that there is a coexistence of potentiality and actuality, a 'methadone multiple', produced through its narrative and material implementations.

Peopling Global Health / A Saúde Global centrada nas pessoas

The field of Global Health brings together a vastly diverse array of actors working to address pressing health issues worldwide with unprecedented financial and technological resources and informed by various agendas. While Global Health initiatives are booming and displacing earlier framings of the field (such as tropical medicine or international health), critical analyses of the social, political, and economic processes associated with this expanding field — an “open source anarchy” on the ground — are still few and far between. In this essay, we contend that, among the powerful players of Global Health, the supposed beneficiaries of interventions are generally lost from view and appear as having little to say or nothing to contribute. We make the case for a more comprehensive and people-centered approach and demonstrate the crucial role of ethnography as an empirical lantern in Global Health. By shifting the emphasis from diseases to people and environments, and from trickle-down access to equality, we have the opportunity to set a humane agenda that both realistically confronts challenges and expands our vision of the future of global communities...

O campo da saúde global articula um diversificado leque de atores que trabalham para resolver problemas prementes de saúde em todo o mundo, com recursos financeiros e tecnológicos sem precedentes e munidos de agendas das mais variadas. Apesar das iniciativas em saúde global estarem crescendo de forma expressiva e deslocando enquadramentos anteriores do campo (como a medicina tropical ou saúde internacional), as análises críticas dos processos sociais, políticos e econômicos associados a essa expansão ainda são escassas. Neste artigo sustentamos, a partir de uma perspectiva que leva em conta os sujeitos, que o campo da saúde global é uma “anarquia de código aberto”. Em geral, perdem-se de vista os supostos beneficiários das intervenções, que aparecem como tendo pouco a dizer e nada a contribuir. Argumentamos por uma abordagem mais abrangente e centrada nas pessoas, demonstrando o papel crucial da etnografia como lanterna empírica na saúde global. Ao mudar a ênfase das doenças às pessoas e seus contextos e do acesso de cima para baixo para a equidade, temos a oportunidade de definir uma agenda humana que simultaneamente confronta realisticamente os desafios que enfrentamos e expande nossa visão sobre o futuro das comunidades globais...