Identifying Metabolic Diseases That Precipitate Neonatal Seizures.

Although a rare cause of neonatal seizures, inborn errors of metabolism (IEMs) remain an essential component of a comprehensive differential diagnosis for poorly controlled neonatal epilepsy. Diagnosing neonatal-onset metabolic conditions proves a difficult task for clinicians; however, routine state newborn screening panels now include many IEMs. Three in particular-pyridoxine-dependent epilepsy, maple syrup urine disease, and Zellweger spectrum disorders-are highly associated with neonatal epilepsy and neurocognitive injury yet are often misdiagnosed. As research surrounding biomarkers for these conditions is emerging and gene sequencing technologies are advancing, clinicians are beginning to better establish early identification strategies for these diseases. In this literature review, the authors aim to present clinicians with an innovative clinical guide highlighting IEMs associated with neonatal-onset seizures, with the goal of promoting quality care and safety.

Investigating health and social outcomes of the Big Local community empowerment initiative in England: a mixed method evaluation.

Background: Most research on community empowerment provides evidence on engaging communities for health promotion purposes rather than attempts to create empowering conditions. This study addresses this gap. Intervention: Big Local started in 2010 with £271M from the National Lottery. Ending in 2026, it gives 150 relatively disadvantaged communities in England control over £1M to improve their neighbourhoods. Objective: To investigate health and social outcomes, at the population level and among engaged residents, of the community engagement approach adopted in a place-based empowerment initiative. Study design, data sources and outcome variables: This study reports on the third wave of a longitudinal mixed-methods evaluation. Work package 1 used a difference-in-differences design to investigate the impact of Big Local on population outcomes in all 150 Big Local areas compared to matched comparator areas using secondary data. The primary outcome was anxiety; secondary outcomes included a population mental health measure and crime in the neighbourhood. Work package 2 assessed active engagement in Big Local using cross-sectional data and nested cohort data from a biannual survey of Big Local partnership members. The primary outcome was mental well-being and the secondary outcome was self-rated health. Work package 3 conducted qualitative research in 14 Big Local neighbourhoods and nationally to understand pathways to impact. Work package 4 undertook a cost-benefit analysis using the life satisfaction approach to value the benefits of Big Local, which used the work package 1 estimate of Big Local impact on life satisfaction. Results: At a population level, the impacts on 'reporting high anxiety' (-0.8 percentage points, 95% confidence interval -2.4 to 0.7) and secondary outcomes were not statistically significant, except burglary (-0.054 change in z-score, 95% confidence interval -0.100 to -0.009). There was some effect on reduced anxiety after 2017. Areas progressing fastest had a statistically significant reduction in population mental health measure (-0.053 change in z-score, 95% confidence interval -0.103 to -0.002). Mixed results were found among engaged residents, including a significant increase in mental well-being in Big Local residents in the nested cohort in 2018, but not by 2020; this is likely to be COVID-19. More highly educated residents, and males, were more likely to report a significant improvement in mental well-being. Qualitative accounts of positive impacts on mental well-being are often related to improved social connectivity and physical/material environments. Qualitative data revealed increasing capabilities for residents' collective control. Some negative impacts were reported, with local factors sometimes undermining residents' ability to exercise collective control. Finally, on the most conservative estimate, the cost-benefit calculations generate a net benefit estimate of £64M. Main limitations: COVID-19 impacted fieldwork and interpretation of survey data. There was a short 4-year follow-up (2016/20), no comparators in work package 2 and a lack of power to look at variations across areas. Conclusions: Our findings suggest the need for investment to support community organisations to emerge from and work with communities. Residents should lead the prioritisation of issues and design of solutions but not necessarily lead action; rather, agencies should work as equal partners with communities to deliver change. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research Programme (16/09/13) and will be published in full in Public Health Research; Vol. 11, No. 9. See the NIHR Journals Library website for further project information.

The Communities in Control study is looking at the health impacts of the Big Local community empowerment programme, funded by the National Lottery Community Fund and managed by Local Trust (a national charitable organisation). Residents of 150 English areas have at least £1M and other support to improve the neighbourhoods. There have been three phases of the research. This report shares findings from their third phase, which began in 2018. First, we used data from a national survey and data from national health and welfare services to compare changes in mental health between people living in Big Local areas and those in similar areas that did not have a Big Local partnership. Furthermore, we also used publicly available data on crime in the neighbourhoods. We found weak evidence that Big Local was linked with improved mental health and a reduction in burglaries. Second, we used data from a survey conducted by Local Trust to look at health and social impacts on the most active residents. We found an increase in mental well-being in 2018 but this was not maintained in 2020, probably due to the COVID-19 pandemic. Third, we did interviews and observations in 14 Big Local areas to understand what helps and what does not help residents to improve their neighbourhoods. We found that partnerships need to have legitimacy, the right balance of support, and learning opportunities. Residents suggested that creating social connections and welcoming social spaces, improving how people view the area and tackling poverty contributed to health improvements. Direct involvement in Big Local was both stressful and rewarding. Finally, we did a cost­benefit analysis by putting a monetary value on residents' increase in life satisfaction due to Big Local and comparing it with the costs of Big Local. We found that the benefits exceed the costs by at least £60M, suggesting that Big Local provides good value for money.

Framings of risk and responsibility in newsprint media coverage of alcohol licensing regulations during the COVID-19 pandemic in England.

INTRODUCTION: Licensing is recognised as a World Health Organization (WHO) 'best buy' for reducing alcohol harms. In response to the 2020 COVID-19 outbreak, many countries-imposed restrictions on outlets selling alcohol to reduce virus transmission. In England, while shops selling alcohol were deemed 'essential', multiple restrictions were imposed on licenced outlets such as pubs and bars. Media reporting of licensing restrictions during the pandemic might have shaped public discourses of alcohol risks and responsibilities. METHODS: This study aimed to understand how alcohol licensing changes in England were framed in newsprint media. Two hundred and fifty-three relevant articles from UK newsprint publications were identified through the Nexis database, published within six time points between March and December 2020 reflecting key changes to licencing in England. Thematic analysis, drawing on framing theory, was conducted to identify 'problems' framed in the reporting of these changes. RESULTS: Four dominant framings were identified: (i) licensed premises as 'risky' spaces; (ii) problematic drinking practices; (iii) problematic policy responses; and (iv) 'victimisation' of licensed premises. The presence of these framings shifted across the reporting period, but consistently, social disorder was constructed as a key risk relating to licensing changes over health harms from alcohol consumption. DISCUSSION AND CONCLUSIONS: The analysis shows newsprint media reproduced narratives of 'inevitable' drinking culture and social disorder, but also emphasised expectations for evidence-based policy-making, in the context of licensing during the pandemic. Discourses of dissatisfaction with licensing decisions suggests potential for public health advocacy to push for licensing change to reduce alcohol health harms, in England and internationally.

Understanding antimicrobial use in subsistence farmers in Chikwawa District Malawi, implications for public awareness campaigns.

Drug resistant infections are increasing across the world and urgent action is required to preserve current classes of antibiotics. Antibiotic use practices in low-and-middle-income countries have gained international attention, especially as antibiotics are often accessed beyond the formal health system. Public awareness campaigns have gained popularity, often conceptualising antimicrobial resistance (AMR) as a problem of excess, precipitated by irrational behaviour. Insufficient attention has been paid to people's lived experiences of accessing medicines in low-income contexts. In Chikwawa District, Malawi, a place of extreme scarcity, our study aimed to understand the care and medicine use practices of households dependent on subsistence farming. Adopting an anthropological approach, we undertook medicine interviews (100), ethnographic fieldwork (six-month period) and key informant interviews (33) with a range of participants in two villages in rural Chikwawa. The most frequently used drugs were cotrimoxazole and amoxicillin, not considered to be of critical importance to human health. Participants recognised that keeping, sharing, and buying medicines informally was not the "right thing." However, they described using antibiotics and other medicines in these ways due to conditions of extreme precarity, the costs and limitations of seeking formal care in the public sector, and the inevitability of future illness. Our findings emphasise the need in contexts of extreme scarcity to equip policy actors with interventions to address AMR through strengthening health systems, rather than public awareness campaigns that foreground overuse and the dangers of using antibiotics beyond the formal sector.

Understanding antimicrobial resistance through the lens of antibiotic vulnerabilities in primary health care in rural Malawi.

The diminishing effectiveness of antimicrobials raises serious concerns for human health. While policy makers grapple to reduce the overuse of antimicrobial medicines to stem the rise of antimicrobial resistance, insufficient attention has been paid to how this applies to low-resource contexts. We provide an in-depth portrayal of antimicrobial prescribing at primary health care level in rural Chikwawa District, Malawi. Ethnographic fieldwork took place over 18 months (2018-2020). We surveyed 22 health facilities in the district, observed 1348 health worker-patient consultations, and carried out 49 in-depth interviews with staff and patients. Care was centred around provision of an antimicrobial. Amid chronic lack of essential medicines and other resources, clinic interactions were tightly scripted, providing patients little time to question or negotiate their treatment. We develop the concept of 'antibiotic vulnerabilities' to reveal multiple ways in which provision of antimicrobials in rural Malawi impacts care in conditions of extreme scarcity. Antibiotics are central and essential to primary care. As targets for optimal antimicrobial prescribing take a more central role in global policy, close attention is required of the ramifications for the delivery of care to ensure that efforts to stem resistance do not undermine the goal of improved health for all.

Conceptualising and constructing 'diversity' through experiences of public and patient involvement in health research.

BACKGROUND: Increasing the accessibility of public and patient involvement (PPI) in health research for people from diverse backgrounds is important for ensuring all voices are heard and represented. Critiques of PPI being dominated by 'the usual suspects' reflect concerns over the barriers to involvement in PPI faced by people from minority groups or non-professional backgrounds. Yet, what has received less attention is how undertaking PPI work might produce diverse experiences, potentially shaping the motivation and capacity of people from different backgrounds to continue in PPI. METHODS: We conducted qualitative research to explore experiences of the health research PPI field in the UK and to understand how these might shape the accessibility of PPI for people of diverse backgrounds. We conducted in-depth and follow-up interviews with five PPI contributors with experience of multiple health research projects, and a focus group with nine people in professional roles relating to PPI. Interview data were analysed using a narrative approach, and then combined with the focus group data for thematic analysis. RESULTS: The structure, organisation and relationships of health research in the UK all shape PPI experiences in ways that can intersect the different backgrounds and identities of contributors, and can pose barriers to involvement and motivation for some. Navigating processes for claiming expenses can be frustrating particularly for people from lower-income backgrounds or with additional needs, and short-term research can undermine relationships of trust between contributors and professionals. Pressure on PPI coordinators to find 'more diverse' contributors can also undermine ongoing relationships with contributors, and how their inputs are valued. CONCLUSIONS: To increase diversity within PPI, and to ensure that people of different backgrounds are supported and motivated to continue in PPI, changes are needed in the wider health research infrastructure in the UK. More resources are required to support relationships of trust over time between contributors and professionals, and to ensure the unique circumstances of each contributor are accommodated within and across PPI roles. Finally, critical reflection on the pressure in PPI to seek 'more diverse' contributors is needed, to understand the impacts of this on those already involved.

Supporting people from different backgrounds to access public and patient involvement (PPI) roles in health research is important. Increasing 'diversity' in PPI is often thought about in terms of the demographic characteristics (eg gender, ethnicity) of people undertaking PPI roles. However, we also need to understand how people experience PPI differently, and what shapes their ability to become and continue being involved. We conducted in-depth and follow-up interviews with five experienced PPI contributors, and a focus group with nine professionals working in roles around PPI in health research in the UK, to explore their views and experiences of the PPI field over time.Our findings show that how health research is organised impacts the motivation of people from different backgrounds to continue doing PPI, where processes for claiming expenses for PPI work can be particularly challenging for people on a low income and / or with additional needs. Relationships with PPI professionals are important for how valued different PPI contributors feel, but professionals' expectations of PPI roles vary and some contributors feel their experience is not always welcomed. PPI coordinators can feel pressured by researchers to recruit new, 'more diverse' contributors to PPI roles, and they worry that this affects the relationships they have with people already doing PPI. Our research shows the need for more support within health research structures to enable people with different backgrounds and experiences to continue to feel valued and motivated in PPI. This will help ensure health research is informed by diverse perspectives.

"An Active, Productive Life": Narratives of, and Through, Participation in Public and Patient Involvement in Health Research.

Public and patient involvement (PPI)-engaging the public in designing and delivering research-is increasingly expected in health research, reflecting recognition of the value of "lay" knowledge of illness and/or caring for informing research. Despite increased understanding of PPI experiences within the research process, little attention has been paid to the meaning of PPI in other areas of contributors' lives, and its value as a broader social practice. We conducted repeated narrative interviews with five experienced PPI contributors from the United Kingdom to explore how meaning is constructed through narratives of PPI in relation to their broader "life-worlds." Narratives were extremely varied, constructing identities and meanings around PPI in relation to family and social life, career and employment, financial status, and wider social agendas, as well as health. This emphasizes the importance of recognizing PPI as a social practice with diverse meaning and value beyond health research.

'The opportunity to have their say'? Identifying mechanisms of community engagement in local alcohol decision-making.

BACKGROUND: Engaging the community in decisions-making is recognised as important for improving public health, and is recommended in global alcohol strategies, and in national policies on controlling alcohol availability. Yet there is little understanding of how to engage communities to influence decision-making to help reduce alcohol-related harms. We sought to identify and understand mechanisms of community engagement in decision-making concerning the local alcohol environment in England. METHODS: We conducted case studies in three local government areas in England in 2018, purposively selected for examples of community engagement in decisions affecting the local alcohol environment. We conducted 20 semi-structured interviews with residents, workers, local politicians and local government practitioners, and analysed documents linked to engagement and alcohol decision-making. RESULTS: Four rationales for engaging the community in decision-making affecting the alcohol environment were identified: i) as part of statutory decision-making processes; ii) to develop new policies; iii) as representation on committees; and iv) occurring through relationship building. Many of the examples related to alcohol licensing processes, but also local economy and community safety decision-making. The impact of community inputs on decisions was often not clear, but there were a few instances of engagement influencing the process and outcome of decision-making relating to the alcohol environment. CONCLUSIONS: While influencing statutory licensing decision-making is challenging, community experiences of alcohol-related harms can be valuable 'evidence' to support new licensing policies. Informal relationship-building between communities and local government is also beneficial for sharing information about alcohol-related harms and to facilitate future engagement. However, care must be taken to balance the different interests among diverse community actors relating to the local alcohol environment, and extra support is needed for those with least capacity to engage but who face more burden of alcohol-related harms, to avoid compounding existing inequalities.

Accessibility of 'essential' alcohol in the time of COVID-19: Casting light on the blind spots of licensing?

Among the Australian and UK governments' responses to the COVID-19 pandemic has been the designation of outlets selling alcohol for off-premise consumption as 'essential' services, allowing them to remain open while pubs, hotels and restaurants have been forced to close. In a context of restrictions on movement outside the home in both countries, and where alcohol providers are trying to find new ways to reach their customers, this may lead to an intensification of the social and health harms associated with home drinking. By examining the current situation in both Australia and the UK, we argue that heightened risks from home drinking amid COVID-19 bring into sharp focus long-standing weaknesses within licensing systems in both countries: the regulation of off-premise outlets to minimise harms from drinking at home. We call for critical conversations on how licensing systems should be revised to take more responsibility for protecting people from the health and social harms associated with home drinking, both under COVID-19 and in the future.

Identifying opportunities for engaging the 'community' in local alcohol decision-making: A literature review and synthesis.

INTRODUCTION: Engaging communities in actions to reduce alcohol harms has been identified as an international priority. While there exist recommendations for community engagement within alcohol licensing legislation, there is limited understanding of how to involve communities in local decision-making to reduce harms from the alcohol environment. METHODS: A scoping literature review was conducted on community engagement in local government decision-making with relevance to the alcohol environment. Academic and grey literature databases were searched between April and June 2018 to identify examples of community engagement in local government in the UK, published since 2000. Texts were excluded if they did not describe in detail the mechanisms or rationale for community engagement. Information was extracted and synthesised through a narrative approach. RESULTS: 3030 texts were identified through the searches, and 30 texts were included in the final review. Only one text described community engagement in alcohol decision-making (licensing); other local government sectors included planning, regeneration and community safety. Four rationales for community engagement emerged: statutory consultation processes; non-statutory engagement; as part of broader participatory initiatives; and community-led activism. While not all texts reported outcomes, a few described direct community influence on decisions. Broader outcomes included improved relationships between community groups and local government. However, lack of influence over decisions was also common, with multiple barriers to effective engagement identified. CONCLUSION: The lack of published examples of community engagement in local alcohol decision-making relevant to the UK suggests little priority has been placed on sharing learning about supporting engagement in this area. Taking a place-shaping perspective, useful lessons can be drawn from other areas of local government with relevance for the alcohol environment. Barriers to engagement must be considered carefully, particularly around how communities are defined, and how different interests toward the local alcohol environment are represented, or not.

Ethnography and evaluation: temporalities of complex systems and methodological complexity.

In public health there is increased focus on evaluating 'complex' interventions for health improvement, examining how their multiple components interact dynamically with the contextual system in which they are delivered. Amid this complexity framing are calls for methodologies that can facilitate contextual understanding as part of the evaluation process, including ethnography. However, while ethnography's attention to 'context' has been recognised as valuable for evaluation, few questions have been raised about the possible tensions of aligning what are quite different expectations for knowledge making in evaluation and in ethnography. This paper introduces a special section illustrating empirical examples of conducting ethnography for and with evaluation of 'complex' health interventions. Central to these experiences, this paper argues, are the concepts of time and temporality through which experience, change and knowledge making are invariably structured. It considers the different expectations for time and temporality in ethnographic and evaluation research, and how the 'long conversation' of ethnography aids interpretation of an intervention's interaction with the pasts, presents and possible futures of people's health experiences. Furthermore, in understanding time not as linear and constant but experienced through a series of encounters, ethnography highlights the spaces in between action and change, vital for understanding the complex dynamics of a health intervention in context. Through temporality, this paper and the related empirical papers present an intricate exploration of the challenges and productive opportunities posed by the use of ethnography for and with evaluation.

'A true partner around the table?' Perceptions of how to strengthen public health's contributions to the alcohol licensing process.

INTRODUCTION: There are increased opportunities for public health practitioners (PHPs) in England to shape alcohol availability and reduce harms through a statutory role in licensing processes in local government. However, how public health can effectively influence alcohol licence decision-making is little understood. METHODS: A mixed methods study was conducted to identify challenges faced by PHPs and mechanisms to strengthen their role. This involved a survey of practitioners across London local authorities (n = 18) and four focus group discussions with a range of licensing stakeholders (n = 36). RESULTS: Survey results indicated a varied picture of workload, capacity to respond to licence applications and levels of influence over decision-making among PHPs in London. Practitioners described a felt lack of status within the licence process, and difficulties using and communicating public health evidence effectively, without a health licensing objective. Strategies considered supportive included engaging with other responsible authorities and developing understanding and relationships over time. CONCLUSIONS: Against political and resource constraints at local and national government levels, pragmatic approaches for strengthening public health influence over alcohol licensing are required, including promoting relationships between stakeholders and offering opportunities for PHPs to share best practice about making effective contributions to licensing.

Processes, practices and influence: a mixed methods study of public health contributions to alcohol licensing in local government.

BACKGROUND: Public health in England has opportunities to reduce alcohol-related harms via shaping the availability and accessibility of alcohol through the licensing function in local government. While the constraints of licensing legislation have been recognised, what is currently little understood are the day-to-day realities of how public health practitioners enact the licensing role, and how they can influence the local alcohol environment. METHODS: To address this, a mixed-methods study was conducted across 24 local authorities in Greater London between 2016 and 17. Data collection involved ethnographic observation of public health practitioners' alcohol licensing work (in eight local authorities); a survey of public health practitioners (n = 18); interviews with licensing stakeholders (n = 10); and analysis of public health licensing data from five local authorities. Fieldnotes and interview transcripts were analysed thematically, and quantitative data were analysed using descriptive statistics. RESULTS: Results indicated that some public health teams struggle to justify the resources required to engage with licensing processes when they perceive little capacity to influence licensing decisions. Other public health teams consider the licensing role as important for shaping the local alcohol environment, and also as a strategic approach for positioning public health within the council. Practitioners use different processes to assess the potential risks of licence applications but also the potential strengths of their objections, to determine when and how actions should be taken. Identifying the direct influence of public health on individual licences is challenging, but the study revealed how practitioners did achieve some level of impact, for example through negotiation with applicants. CONCLUSIONS: This study shows public health impact following alcohol licensing work is difficult to measure in terms of reducing alcohol-related harms, which poses challenges for justifying this work amid resource constraints. However, there is potential added value of the licensing role in strategic positioning of public health in local government to influence broader determinants of health.

"We're all thrown in the same boat ": A qualitative analysis of peer support in dementia care.

Peer support is well established in fields such as the disability movement and mental health and is increasingly recognised as one way of enabling support by and for people with a diagnosis of dementia and their immediate carers. It was central to the implementation of the National Dementia Strategy (NDS) for England, when 40 demonstration sites were established. This mixed-methods study included in-depth qualitative interviews with people living with dementia (n = 101) and staff/stakeholders (n = 82) at 8 of the 40 sites. Data analysis was a five-stage process: coding framework developed (using 25 transcripts); further development of the framework (using a further 70 transcripts); development of emerging themes; modelling of themes and verification of models based on the entire data set. Peer support had positive emotional and social impact that was rooted in identification with others, a commonality of experience and reciprocity of support. There was also a contrast between the quality of peer support and support from professionals. This emphasises the significance of lived experience and promoting a strength-based approach to interpersonal support that is enabling and challenges a deficit approach to understanding dementia.

Examining Intervention Design: Lessons from the Development of Eight Related Malaria Health Care Intervention Studies.

Abstract-Rigorous evidence of "what works" to improve health care is in demand, but methods for the development of interventions have not been scrutinized in the same ways as methods for evaluation. This article presents and examines intervention development processes of eight malaria health care interventions in East and West Africa. A case study approach was used to draw out experiences and insights from multidisciplinary teams who undertook to design and evaluate these studies. Four steps appeared necessary for intervention design: (1) definition of scope, with reference to evaluation possibilities; (2) research to inform design, including evidence and theory reviews and empirical formative research; (3) intervention design, including consideration and selection of approaches and development of activities and materials; and (4) refining and finalizing the intervention, incorporating piloting and pretesting. Alongside these steps, projects produced theories, explicitly or implicitly, about (1) intended pathways of change and (2) how their intervention would be implemented.The work required to design interventions that meet and contribute to current standards of evidence should not be underestimated. Furthermore, the process should be recognized not only as technical but as the result of micro and macro social, political, and economic contexts, which should be acknowledged and documented in order to infer generalizability. Reporting of interventions should go beyond descriptions of final intervention components or techniques to encompass the development process. The role that evaluation possibilities play in intervention design should be brought to the fore in debates over health care improvement.

Conceptualising the 'community' as a recipient of money--A critical literature review, and implications for health and inequalities.

There is increasing attention on how money may bring about positive changes to health, and money-based development approaches are becoming more commonplace at the 'community' level, including in high-income countries. However, little attention has been paid to how the 'community' might be varyingly conceptualised in these scenarios, or to the potential implications of this for interpreting the impacts of such health improvement approaches. This paper presents a critical interpretive review of literature presenting different scenarios from high-income countries in which the 'community' receives money, to explore how 'community' is conceptualised in relation to this process. Some texts gave explicit definitions of 'community', but multiple other conceptualisations were interpreted across all texts, conveyed through the construction of 'problematics', and descriptions of how and why money was given. The findings indicate that the flow of money shapes how conceptualisations of 'community' are produced, and that the implicit power relations and inequalities can construct and privilege particular sets of identities and relationships throughout the process. This highlights implications for approaching public health evaluations of giving money to 'communities', and for better understanding how it might bring about change to health and inequalities, where the 'community' cannot be interpreted merely as a setting or recipient of such an intervention, but something constructed and negotiated through the flow of money itself.

Introduction of Syphilis Point-of-Care Tests, from Pilot Study to National Programme Implementation in Zambia: A Qualitative Study of Healthcare Workers' Perspectives on Testing, Training and Quality Assurance.

Syphilis affects 1.4 million pregnant women globally each year. Maternal syphilis causes congenital syphilis in over half of affected pregnancies, leading to early foetal loss, pregnancy complications, stillbirth and neonatal death. Syphilis is under-diagnosed in pregnant women. Point-of-care rapid syphilis tests (RST) allow for same-day treatment and address logistical barriers to testing encountered with standard Rapid Plasma Reagin testing. Recent literature emphasises successful introduction of new health technologies requires healthcare worker (HCW) acceptance, effective training, quality monitoring and robust health systems. Following a successful pilot, the Zambian Ministry of Health (MoH) adopted RST into policy, integrating them into prevention of mother-to-child transmission of HIV clinics in four underserved Zambian districts. We compare HCW experiences, including challenges encountered in scaling up from a highly supported NGO-led pilot to a large-scale MoH-led national programme. Questionnaires were administered through structured interviews of 16 HCWs in two pilot districts and 24 HCWs in two different rollout districts. Supplementary data were gathered via stakeholder interviews, clinic registers and supervisory visits. Using a conceptual framework adapted from health technology literature, we explored RST acceptance and usability. Quantitative data were analysed using descriptive statistics. Key themes in qualitative data were explored using template analysis. Overall, HCWs accepted RST as learnable, suitable, effective tools to improve antenatal services, which were usable in diverse clinical settings. Changes in training, supervision and quality monitoring models between pilot and rollout may have influenced rollout HCW acceptance and compromised testing quality. While quality monitoring was integrated into national policy and training, implementation was limited during rollout despite financial support and mentorship. We illustrate that new health technology pilot research can rapidly translate into policy change and scale-up. However, training, supervision and quality assurance models should be reviewed and strengthened as rollout of the Zambian RST programme continues.

"Every drug goes to treat its own disease " - a qualitative study of perceptions and experiences of taking anti-retrovirals concomitantly with anti-malarials among those affected by HIV and malaria in Tanzania.

BACKGROUND: Little is known about how people living with human immunodeficiency virus (HIV) experience malaria and the concomitant use of anti-malarial treatments with anti-retrovirals (ARVs). An understanding of how patients make sense of these experiences is important to consider in planning and supporting the clinical management and treatment for co-infected individuals. METHODS: A qualitative study was conducted in Tanzania alongside a clinical trial of concomitant treatment for HIV and malaria co-infection. Focus group discussions were held with people receiving treatment for HIV and/or malaria, and in-depth interviews with health workers responsible for HIV care and members of the clinical trial team. Data were analysed inductively to identify themes and develop theoretical narratives. RESULTS: Results suggest that people living with HIV perceived malaria to be more harmful to them due to their compromised immune status but saw the disease as unavoidable. For those enrolled in the clinical controlled study, taking anti-malarials together with ARVs was largely seen as unproblematic, with health workers' advice and endorsement of concomitant drug taking influential in reported adherence. However, perceptions of drug strength appeared to compel some people not enrolled in the clinical study to take the drugs at separate times to avoid anticipated harm to the body. CONCLUSIONS: Management of HIV and malaria concurrently often requires individuals to cross the domains of different disease programmes. In the context of a trial concerned with both diseases, patients experienced the support of clinicians in guiding and reassuring them about when and how to take drugs concomitantly. This points towards the need to continue to strive for integrated care for patients with HIV.

The practice of 'doing' evaluation: lessons learned from nine complex intervention trials in action.

BACKGROUND: There is increasing recognition among trialists of the challenges in understanding how particular 'real-life' contexts influence the delivery and receipt of complex health interventions. Evaluations of interventions to change health worker and/or patient behaviours in health service settings exemplify these challenges. When interpreting evaluation data, deviation from intended intervention implementation is accounted for through process evaluations of fidelity, reach, and intensity. However, no such systematic approach has been proposed to account for the way evaluation activities may deviate in practice from assumptions made when data are interpreted. METHODS: A collective case study was conducted to explore experiences of undertaking evaluation activities in the real-life contexts of nine complex intervention trials seeking to improve appropriate diagnosis and treatment of malaria in varied health service settings. Multiple sources of data were used, including in-depth interviews with investigators, participant-observation of studies, and rounds of discussion and reflection. RESULTS AND DISCUSSION: From our experiences of the realities of conducting these evaluations, we identified six key 'lessons learned' about ways to become aware of and manage aspects of the fabric of trials involving the interface of researchers, fieldworkers, participants and data collection tools that may affect the intended production of data and interpretation of findings. These lessons included: foster a shared understanding across the study team of how individual practices contribute to the study goals; promote and facilitate within-team communications for ongoing reflection on the progress of the evaluation; establish processes for ongoing collaboration and dialogue between sub-study teams; the importance of a field research coordinator bridging everyday project management with scientific oversight; collect and review reflective field notes on the progress of the evaluation to aid interpretation of outcomes; and these approaches should help the identification of and reflection on possible overlaps between the evaluation and intervention. CONCLUSION: The lessons we have drawn point to the principle of reflexivity that, we argue, needs to become part of standard practice in the conduct of evaluations of complex interventions to promote more meaningful interpretations of the effects of an intervention and to better inform future implementation and decision-making.

' in the project they really care for us': meaning and experiences of participating in a clinical study of first-line treatment for malaria and HIV in Tanzanian adults.

Critiques of biomedical research in low-resource settings typically centre on clinical trials and the 'dissymmetries of power' between the researched and those benefiting from the products of research. It is important to extend this critical lens to other forms of global health research. We conducted a qualitative study in Tanzania to explore meaning and experiences of participating in a clinical observational study evaluating the safety and efficacy of current practice for treating HIV and malaria co-infection. Focus group discussions and in-depth interviews were undertaken with 124 study participants, study staff and health workers. Participants' understanding of the study's research aims was limited, but the practice of participation - engaging with research staff and materials - appeared to facilitate interpretations of the study's value, conceptualised as a 'service'. For those peripheral to the study, however, interpretations of it reflected existing suspicions of experimental research. Our findings indicate the importance of considering the expectations, roles and responsibilities constructed through the practice of participation in different types of research, and how they relate to legacies of research. Understanding how networks of research practice intersect local social and historical contexts can extend discussions of collaboration and engagement with research in low-resource settings.