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Abstract Background The relationship between healthcare interventions and context is widely conceived as involving complex and dynamic interactions over time. However, evaluations of complex health interventions frequently fail to mobilise such complexity, reporting context and interventions as reified and demarcated categories. This raises questions about practices shaping knowledge about context, with implications for who and what we make visible in our research. Viewed through the lens of case study research, we draw on data collected for the Triple C study (focused on Case study, Context and Complex interventions), to critique these practices, and call for system-wide changes in how notions of context are operationalised in evaluations of complex health interventions. Methods The Triple C study was funded by the Medical Research Council to develop case study guidance and reporting principles taking account of context and complexity. As part of this study, a one-day workshop with 58 participants and nine interviews were conducted with those involved in researching, evaluating, publishing, funding and developing policy and practice from case study research. Discussions focused on how to conceptualise and operationalise context within case study evaluations of complex health interventions. Analysis focused on different constructions and connections of context in relation to complex interventions and the wider social forces structuring participant’s accounts. Results We found knowledge-making practices about context shaped by epistemic and political forces, manifesting as: tensions between articulating complexity and clarity of description; ontological (in)coherence between conceptualisations of context and methods used; and reified versions of context being privileged when communicating with funders, journals, policymakers and publics. Conclusion We argue that evaluations of complex health interventions urgently requires wide-scale critical reflection on how context is mobilised - by funders, health services researchers, journal editors and policymakers. Connecting with how scholars approach complexity and context across disciplines provides opportunities for creatively expanding the field in which health evaluations are conducted, enabling a critical standpoint to long-established traditions and opening up possibilities for innovating the design of evaluations of complex health interventions.

Objective To understand the experiences and perceptions of sexual health professionals responding to the May 2022 mpox outbreak in the UK.Design Cross-sectional, anonymous, online survey collecting quantitative and qualitative data. Convenience sample recruited via an international network of sexual health and HIV clinicians responding to mpox and promoted through clinical associations and social media. Survey domains included: clinical workload; preparedness, support, and training; safety at work; vaccination; and well-being. Qualitative descriptive analysis of open-text responses was conducted to support interpretation of the quantitative data.Participants Participants who were employed as sexual health professionals in the UK and had direct clinical experience of mpox were included in the analysis. The survey was completed between 11 August and 31 October 2022 by 139 respondents, the majority of whom were doctors (72.7%), cis-female (70.5%) and White (78.4%).Results 70.3% reported that they were required to respond to mpox in addition to their existing clinical responsibilities, with 46.8% working longer hours as a result. In the open-text data, respondents highlighted that workload pressures were exacerbated by a lack of additional funding for mpox, pre-existing pressures on sexual health services, and unrealistic expectations around capacity. 67.6% of respondents reported experiencing negative emotional impact due to their mpox work, with stress (59.0%), fatigue (43.2%) and anxiety (36.0%) being the most common symptoms. 35.8% stated that they were less likely to remain in their profession because of their experiences during the mpox outbreak. In the open-text data, these feelings were ascribed to post-COVID exhaustion, understaffing and frustration among some participants at the handling of the mpox response.Conclusions These findings indicate that sexual health services require increased funding and resources, along with evidence-based well-being interventions, to support sexual health professionals’ outbreak preparedness and recovery.

Abstract Case study methodology is widely used in health research, but has had a marginal role in evaluative studies, given it is often assumed that case studies offer little for making causal inferences. We undertook a narrative review of examples of case study research from public health and health services evaluations, with a focus on interventions addressing health inequalities. We identified five types of contribution these case studies made to evidence for causal relationships. These contributions relate to: (1) evidence about system actors’ own theories of causality; (2) demonstrative examples of causal relationships; (3) evidence about causal mechanisms; (4) evidence about the conditions under which causal mechanisms operate; and (5) inference about causality in complex systems. Case studies can and do contribute to understanding causal relationships. More transparency in the reporting of case studies would enhance their discoverability, and aid the development of a robust and pluralistic evidence base for public health and health services interventions. To strengthen the contribution that case studies make to that evidence base, researchers could: draw on wider methods from the political and social sciences, in particular on methods for robust analysis; carefully consider what population their case is a case ‘of’; and explicate the rationale used for making causal inferences.

Introduction Cabotegravir and rilpivirine (CAB+RPV long-acting (LA)) is recommended as a treatment for HIV-1 allowing people living with HIV to receive 2 monthly injectable treatment, rather than daily pills. Providing injectable therapy in a system designed to provide and manage study participants on oral treatments poses logistical challenges namely how resources are used to accommodate patient preference within constrained health economies with capacity limitations. In this pragmatic multicentre study, we aim to understand the implementation of CAB-RPV-LA administration in two settings via mixed methods to explore perspectives of participants and the clinical team delivering CAB+RPV LA.Methods and analysis Women, racially minoritised people and older people are chronically under-represented in HIV clinical trials so the ILANA trial has set recruitment caps to ensure recruitment of 50% women, 50% ethnically diverse people and 30% over 50 years of age to include a more representative study population. Using a mixed-methods approach, the primary objective is to identify and evaluate the critical implementation strategies for CAB+RPV LA in both hospital and community settings. Secondary objectives include evaluating feasibility and acceptability of CAB+RPV LA administration at UK clinics and community settings from the perspective of HIV care providers, nurses and representatives at community sites, evaluating barriers to implementation, the utility of implementation strategies and adherence.Ethics and dissemination Ethical approval has been obtained from the Health Research Authority Research Ethics Committee (REC reference: 22/PR/0318). The dissemination strategy has been formulated with the SHARE Collaborative Community Advisory Board to maximise the impact of this work on clinical care and policy. This strategy draws on and leverages existing resources within the participating organisations, such as their academic infrastructure, professional relationships and community networks. The strategy will leverage the Public Engagement Team and press office to support dissemination of findings.Trial registration number NCT05294159.

Background: Tecovirimat, an antiviral treatment for smallpox, was approved as a treatment for mpox by the European Medicines Agency in January 2022. Approval was granted under "exceptional circumstances" based on effectiveness found in pre-clinical challenge studies in animals and safety studies in humans showing minimal side effects. As clinical efficacy studies are still ongoing, there is currently limited information with regard to the acceptability of tecovirimat to treat mpox. The aim of this study is to understand prospective acceptability of use of tecovirimat as treatment for mpox. Methods: A co-produced, qualitative, focus group study design was conducted with a theoretically informed sample of people from communities at higher risk and with experience of mpox illness. Thirteen participants took part: all self-identified as cisgender male, 1 self-identified as Black British, 1 as British Asian, 5 as White, 3 as White British, 3 as White Other. Inclusion criteria were as follows: experience of mpox illness; age 18 and over; living in the United Kingdom (UK); living in the UK during 2022 mpox outbreak. Focus groups were recorded, transcribed and thematically analysed using a combination inductive and deductive coding informed by the Treatment Acceptability Framework. Results: Very few participants were aware of tecovirimat as a treatment option and none were offered it during their mpox illness. Key factors influencing acceptability found in this study were as follows: levels of trust in medicine; level of information; provider communication approach; quality of experience of mpox care. Marginalised communities at highest risk of mpox may have prior experience of structural discrimination which can greatly influence treatment acceptability. Conclusions: This exploratory study suggest that offering tecovirimat (or comparable emergency-licensed treatments) to people with mpox is acceptable, although uptake will depend on knowledge of mpox treatment options, trust in medicine and medical professionals and provision of relevant information and choice. To increase acceptability of such treatments, clinicians should ensure patients are aware of mpox symptom management options, including pain relief; acknowledge and address patient concerns upfront and within the context of non-stigmatising care; and communicate offers in a consistent and supportive manner in line with locally approved eligibility criteria and protocols at the time. [ABSTRACT FROM AUTHOR]

In 2022, a global outbreak of mpox (formerly 'monkeypox') emerged in non-endemic countries, including Australia, predominantly affecting gay, bisexual and other men who have sex with men. Public health advice on transmission and isolation emerged rapidly from different sources, sometimes conflicting and producing uncertainty. Using the concept of 'counterpublic health', which acknowledges the incorporation of official science and experiences of affected communities into embodied practice, this paper investigates how people affected by mpox in Australia managed risk of transmission and navigated self-isolation. In-depth interviews were conducted with 16 people: 13 people diagnosed with mpox and three close contacts. All participants were cisgender gay and bisexual men living in Australia. Participants thought critically about public health advice, often finding it restrictive and unresponsive to the needs of people with mpox. Participants' decisions about reducing mpox risk and isolating often drew on experiences with other infections (i.e. HIV; COVID-19) and were made collaboratively with the people closest to them (e.g. partners, friends, family) to sustain relationships. Future public health responses to infectious disease outbreaks would benefit from identifying more opportunities to formalise and embed mechanisms to obtain feedback from affected communities so as to inform responses. [ABSTRACT FROM AUTHOR]

In this study, the NeQuick G and Klobuchar models are evaluated by monitoring performance issues related to ionosphere activity for single-frequency users. The effects of radio frequency (RF) signal propagation through the ionosphere may have a significant impact on satellite communication and navigation systems because of geomagnetic field geometry near the magnetic equator and in the proximity to the high- and low-latitude zones. An ongoing challenge is determining how accurate the ionospheric models employed by existing Global Navigation Satellite Systems (GNSSs) are. This work investigates the patterns of total electron content (TEC) fluctuations over distinct zones from 1 January 2019 to 30 June 2022. Measurements are collected at station networks deployed worldwide. Firstly, monthly and seasonal variations of TECs are analysed. Secondly, the TEC ’availability’ parameter, as the percentage of time when the TEC error is compliant with the specification of the Galileo Single-Frequency Ionosphere Algorithm (’NeQuick G’ model), is introduced. The TEC error defines the difference between (a) the model TEC, obtained by either the NeQuick G or the Klobuchar model over a given station, and (b) the reference TEC, based on observations from networks of GNSS receivers. Finally, the position, velocity, and time (PVT), along with broadcast group delays (BGDs) are analysed and the PVT accuracy is compared between the NeQuick G and Klobuchar models. In 3.5 years, the seasonal behaviour of TEC shows maxima during the March and October equinox and minima during the June and December solstice. Moreover, an increase in the TEC values and the amount of TEC errors are visible as we are approaching the next solar maximum. Preliminary results show a larger associated positioning error using the Klobuchar than the NeQuick G model. However, the difference is zone-dependent, most evident in equatorial regions. This collaborative study of the GRC, NMA, TUW, and SRC was performed under the Framework Partnership Agreements (GSA/GRANT/04/2016).

Extracellular vesicles released by the primary pathogen of periodontal disease Porphyromonas gingivalis (Pg), referred to as outer membrane vesicles (OMVs), have been associated with the pathogenesis of systemic diseases like cardiovascular disease, rheumatoid arthritis, and Alzheimer’s disease. A pathogenic role for Pg by disrupting placental homeostasis was proposed in the association between periodontal disease and adverse pregnancy outcomes. On the basis that trophoblast-derived factors modulate endothelial and immune cell profiles in normal pregnancy and the scarce presence of Pg in placenta, we hypothesized that OMVs from Pg affect trophoblast cell phenotype, impairing trophoblast–endothelium and trophoblast–neutrophil interactions. By means of in vitro designs with first-trimester human trophoblast cells, endothelial cells, and freshly isolated neutrophils, we showed that Pg OMVs are internalized by trophoblast cells and modulate the activity and expression of functional markers. Trophoblast cells primed with Pg OMVs enhanced neutrophil chemoattraction and lost their anti-inflammatory effect. In addition, reduced migration with enhanced adhesion of monocytes was found in endothelial cells upon incubation with the media from trophoblast cells pretreated with Pg OMVs. Taken together, the results support a pathogenic role of Pg OMVs at early stages of pregnancy and placentation through disruption of trophoblast contribution to vascular transformation and immune homeostasis maintenance.

Abstract Background There is a growing need for methods that acknowledge and successfully capture the dynamic interaction between context and implementation of complex interventions. Case study research has the potential to provide such understanding, enabling in-depth investigation of the particularities of phenomena. However, there is limited guidance on how and when to best use different case study research approaches when evaluating complex interventions. This study aimed to review and synthesise the literature on case study research across relevant disciplines, and determine relevance to the study of contextual influences on complex interventions in health systems and public health research. Methods Systematic meta-narrative review of the literature comprising (i) a scoping review of seminal texts (n = 60) on case study methodology and on context, complexity and interventions, (ii) detailed review of empirical literature on case study, context and complex interventions (n = 71), and (iii) identifying and reviewing ‘hybrid papers’ (n = 8) focused on the merits and challenges of case study in the evaluation of complex interventions. Results We identified four broad (and to some extent overlapping) research traditions, all using case study in a slightly different way and with different goals: 1) developing and testing complex interventions in healthcare; 2) analysing change in organisations; 3) undertaking realist evaluations; 4) studying complex change naturalistically. Each tradition conceptualised context differently—respectively as the backdrop to, or factors impacting on, the intervention; sets of interacting conditions and relationships; circumstances triggering intervention mechanisms; and socially structured practices. Overall, these traditions drew on a small number of case study methodologists and disciplines. Few studies problematised the nature and boundaries of ‘the case’ and ‘context’ or considered the implications of such conceptualisations for methods and knowledge production. Conclusions Case study research on complex interventions in healthcare draws on a number of different research traditions, each with different epistemological and methodological preferences. The approach used and consequences for knowledge produced often remains implicit. This has implications for how researchers, practitioners and decision makers understand, implement and evaluate complex interventions in different settings. Deeper engagement with case study research as a methodology is strongly recommended.

Rationale Aims and Objectives Method Results Conclusion HIV incidence has decreased in England by over a third since 2019. Despite the early success of HIV Pre‐Exposure Prophylaxis (PrEP) in reducing HIV transmission in the United Kingdom, many people who could benefit from HIV PrEP do not yet know about it, or know how to access it.This paper presents the findings of the first England‐wide national peer‐to‐peer based diffusion model to disseminate information about PrEP. Ask Me About PrEP (AMAP) was a 5‐month pilot programme which commenced in November 2021. Volunteer mobilisers were encouraged to use their existing knowledge of their communities and geographical areas to assist them in discussing PrEP with their peers.12 enrolled mobilisers took part in three project evaluation focus groups between November 2021 and March 2022, and five AMAP project staff took part in one focus group in March 2022. Additionally, descriptive statistical analysis explored volunteer mobiliser recruitment to the AMAP project, demographical data of project staff and volunteer mobilisers, volunteer mobiliser attrition rates, and the project's impact.96 volunteers enrolled, completed training and volunteered as mobilisers. Thoroughout the project, mobilisers engaged their peers in 11,889 conversations about PrEP through individual conversations, online group conversations, online workplace educational events, and social media. The focus groups enabled key stakeholders to reflect on their experiences of the pilot programme. Four key themes were identified during the focus groups: motivations to mobilise and recruitment experiences; training, learning, and materials; mobilisation activity; and support and social networking.Our evaluation demonstrates that peer‐to‐peer diffusion models used to increase awareness of HIV PrEP in key unreached groups, offer an acceptable public health intervention model for volunteers and project staff. [ABSTRACT FROM AUTHOR]

In May 2022, a global outbreak of mpox (formerly monkeypox virus) affected thousands of mainly gay and bisexual men. Mpox is usually a time-limited illness that can involve fever, pain, and skin lesions, but may require hospitalisation. There is scant research into the firsthand experiences of people affected by mpox, including experiences of symptoms, healthcare, and recovery. This study considers the different illness narratives of people who experienced mpox in Australia in 2022. In-depth interviews and 6-month follow-up interviews were conducted with 16 people, including 13 people diagnosed with mpox and three close contacts. All participants were cisgender gay or bisexual men living in Australia. Participants' accounts described minor to severe periods of sickness, negative and stigmatising experiences engaging with healthcare, and some participants experienced long-term effects on their sexual well-being and complications from mpox. The emergency outbreak context meant that mpox was highly distressing, making it difficult to manage and producing varying forms of disruption to everyday life. Mpox was narrated as disruptive in different ways: as a minor interruption to holiday plans, a prolonged period of poor health, or a biographically disruptive event prompting a re-evaluation of sexual values and health. This analysis demonstrates that an unfamiliar emergent disease outbreak related to sexual practices and sociality can reconfigure personal life and sexual well-being, suggesting a need to focus on providing quality patient care in outbreaks of mpox and other infectious diseases. [ABSTRACT FROM AUTHOR]

The ongoing multi-country mpox outbreak in previously unaffected countries is primarily affecting sexual networks of men who have sex with men. Evidence is needed on the effectiveness of recommended preventive interventions. To inform WHO guidelines, a systematic review and qualitative evidence synthesis were conducted on mpox preventive behavioural interventions to reduce: (i) sexual acquisition; (ii) onward sexual transmission from confirmed/probable cases; and (iii) utility of asymptomatic testing. Medline, EMBASE, PubMed, Cochrane and WHO trial databases, grey literature and conferences were searched for English-language primary research published since 1 January 2022. A reviewer team performed screening, data extraction and bias assessment. A qualitative thematic synthesis explored views and experiences of engagement in prevention in individuals at increased risk. There were 16 studies: 1 on contact-tracing, 2 on sexual behaviour, and 13 on asymptomatic testing. Although MPXV was detected in varying proportions of samples (0.17%–6.5%), the testing studies provide insufficient evidence to fully evaluate this strategy. For the qualitative evidence synthesis, four studies evaluated the experiences of most affected communities. Preferences about preventive interventions were shaped by: mpox information; the diversity of sexual practices; accessibility and quality of mpox testing and care; and perceived cost to wellbeing. Evidence on the effectiveness of interventions to prevent the sexual transmission of mpox remains scarce. Limited qualitative evidence on values and preferences provides insight into factors influencing intervention acceptability. Given global and local inequities in access to vaccines and treatment, further research is needed to establish the effectiveness of additional interventions. [ABSTRACT FROM AUTHOR]

In this commentary, we take the recent introduction of methadone treatment in response to emerging problems of HIV linked to heroin addiction in Kenya as a case for reflecting on the social science of implementation science. We offer a framework of 'evidence-making intervention' which we hold as distinct from mainstream 'evidence-based intervention' approaches. Whilst accepting that interventions are shaped in their contexts, evidence-based intervention approaches tend to imagine a stable intervention object with universal effect potential. By contrast, an evidence-making intervention approach investigates how an intervention, and the knowledge which constitutes it, is made locally, through its processes of implementation. Drawing on qualitative research generated in Kenya prior to (2012-2013) and during (2014-2015) the implementation of methadone treatment, we explore the making of 'methadone promise' as a case of evidence-making intervention. We show how enactments of methadone promise make multiple methadones, through which a binary is negotiated between the narratives of methadone as hope for addiction recovery and methadone as hope for HIV prevention. Addiction recovery narratives predominate, despite methadone's incorporation into policy via its globally supported HIV prevention evidence-base. Key practices in the making of methadone promise in Kenya include its medicalization, and renaming, as 'medically assisted treatment' - or simply 'MAT' - which distance it from prior constitutions elsewhere as a drug of substitution, and the visualisation of its effects wherein unhealthy people can be seen and shown to have become well. We also show how actors seek to protect the story of methadone promise from counter narratives, including through mass media projects. We conclude that there is no single biomedical object of methadone intervening on a single biological body across contexts, and no single universe of evidence. By giving weight to local rather than outside expert knowledge, and by tracing how the meaning of intervention is made locally through its implementation, we can make visible the multiple enactments of an intervention and how these shape local ecologies of care, including in ways beyond those foreseen by an intervention's evidencing elsewhere.

Abstract Background The need for better methods for evaluation in health research has been widely recognised. The ‘complexity turn’ has drawn attention to the limitations of relying on causal inference from randomised controlled trials alone for understanding whether, and under which conditions, interventions in complex systems improve health services or the public health, and what mechanisms might link interventions and outcomes. We argue that case study research—currently denigrated as poor evidence—is an under-utilised resource for not only providing evidence about context and transferability, but also for helping strengthen causal inferences when pathways between intervention and effects are likely to be non-linear. Main body Case study research, as an overall approach, is based on in-depth explorations of complex phenomena in their natural, or real-life, settings. Empirical case studies typically enable dynamic understanding of complex challenges and provide evidence about causal mechanisms and the necessary and sufficient conditions (contexts) for intervention implementation and effects. This is essential evidence not just for researchers concerned about internal and external validity, but also research users in policy and practice who need to know what the likely effects of complex programmes or interventions will be in their settings. The health sciences have much to learn from scholarship on case study methodology in the social sciences. However, there are multiple challenges in fully exploiting the potential learning from case study research. First are misconceptions that case study research can only provide exploratory or descriptive evidence. Second, there is little consensus about what a case study is, and considerable diversity in how empirical case studies are conducted and reported. Finally, as case study researchers typically (and appropriately) focus on thick description (that captures contextual detail), it can be challenging to identify the key messages related to intervention evaluation from case study reports. Conclusion Whilst the diversity of published case studies in health services and public health research is rich and productive, we recommend further clarity and specific methodological guidance for those reporting case study research for evaluation audiences.