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Abstract Background Health system responsiveness to public priorities and needs is a broad, multi-faceted and complex health system goal thought to be important in promoting inclusivity and reducing system inequity in participation. Power dynamics underlie the complexity of responsiveness but are rarely considered. This paper presents an analysis of various manifestations of power within the responsiveness practices of Health Facility Committees (HFCs) and Sub-county Health Management Teams (SCHMTs) operating at the subnational level in Kenya. Kenyan policy documents identify responsiveness as an important policy goal. Methods Our analysis draws on qualitative data (35 interviews with health managers and local politicians, four focus group discussions with HFC members, observations of SCHMT meetings, and document review) from a study conducted at the Kenyan Coast. We applied a combination of two power frameworks to interpret our findings: Gaventa’s power cube and Long’s actor interface analysis. Results We observed a weakly responsive health system in which system-wide and equity in responsiveness were frequently undermined by varied forms and practices of power. The public were commonly dominated in their interactions with other health system actors: invisible and hidden power interacted to limit their sharing of feedback; while the visible power of organisational hierarchy constrained HFCs’ and SCHMTs’ capacity both to support public feedback mechanisms and to respond to concerns raised. These power practices were underpinned by positional power relationships, personal characteristics, and world views. Nonetheless, HFCs, SCHMTs and the public creatively exercised some power to influence responsiveness, for example through collaborations with political actors. However, most resulting responses were unsustainable, and sometimes undermined equity as politicians sought unfair advantage for their constituents. Conclusion Our findings illuminate the structures and mechanisms that contribute to weak health system responsiveness even in contexts where it is prioritised in policy documents. Supporting inclusion and participation of the public in feedback mechanisms can strengthen receipt of public feedback; however, measures to enhance public agency to participate are also needed. In addition, an organisational environment and culture that empowers health managers to respond to public inputs is required.

Abstract Background The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). Methods We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. Results Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. Conclusions There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics.

Summary: Background: Children in low and middle-income countries remain vulnerable following hospital-discharge. We estimated the incidence and correlates of hospital readmission among young children admitted to nine hospitals in sub-Saharan Africa and South Asia. Methods: This was a secondary analysis of the CHAIN Network prospective cohort enrolled between 20th November 2016 and 31st January 2019. Children aged 2–23 months were eligible for enrolment, if admitted for an acute illness to one of the study hospitals. Exclusions were requiring immediate resuscitation, inability to tolerate oral feeds in their normal state of health, had suspected terminal illness, suspected chromosomal abnormality, trauma, admission for surgery, or their parent/caregiver was unwilling to participate and attend follow-up visits. Data from children discharged alive from the index admission were analysed for hospital readmission within 180-days from discharge. We examined ratios of readmission to post-discharge mortality rates. Using models with death as the competing event, we evaluated demographic, nutritional, clinical, and socioeconomic associations with readmission. Findings: Of 2874 children (1239 (43%) girls, median (IQR) age 10.8 (6.8–15.6) months), 655 readmission episodes occurred among 506 (18%) children (198 (39%) girls): 391 (14%) with one, and 115 (4%) with multiple readmissions, with a rate of: 41.0 (95% CI 38.0–44.3) readmissions/1000 child-months. Median time to readmission was 42 (IQR 15–93) days. 460/655 (70%) and 195/655 (30%) readmissions occurred at index study hospital and non-study hospitals respectively. One-third (N = 213/655, 33%) of readmissions occurred within 30 days of index discharge. Sites with fewest readmissions had the highest post-discharge mortality. Most readmissions to study hospitals (371/450, 81%) were for the same illness as the index admission. Age, prior hospitalisation, chronic conditions, illness severity, and maternal mental health score, but not sex, nutritional status, or physical access to healthcare, were associated with readmission. Interpretation: Readmissions may be appropriate and necessary to reduce post-discharge mortality in high mortality settings. Social and financial support, training on recognition of serious illness for caregivers, and improving discharge procedures, continuity of care and facilitation of readmission need to be tested in intervention studies. We propose the ratio of readmission to post-discharge mortality rates as a marker of overall post-discharge access and care. Funding: The Bill & Melinda Gates Foundation (OPP1131320).

Introduction In 2020, the UK government established a large-scale testing programme to rapidly identify individuals in England who were infected with SARS-CoV-2 and had COVID-19. This comprised part of the UK government’s COVID-19 response strategy, to protect those at risk of severe COVID-19 disease and death and to reduce the burden on the health system. To assess the success of this approach, the UK Health Security Agency (UKHSA) commissioned an independent evaluation of the activities delivered by the National Health System testing programme in England. The primary purpose of this evaluation will be to capture key learnings from the roll-out of testing to different target populations via various testing services between October 2020 and March 2022 and to use these insights to formulate recommendations for future pandemic preparedness strategy. In this protocol, we detail the rationale, approach and study design.Methods and analysis The proposed study involves a stepwise mixed-methods approach, aligned with established methods for the evaluation of complex interventions in health, to retrospectively assess the combined impact of key asymptomatic and symptomatic testing services nationally. The research team will first develop a theory of change, formulated in collaboration with testing service stakeholders, to understand the causal pathways and intended and unintended outcomes of each testing service and explore contextual impacts on each testing service’s intended outcomes. Insights gained will help identify indicators to evaluate how the combined aims of the testing programme were achieved, using a mixed-methods approach.Ethics and dissemination The study protocol was granted ethics approval by the UKHSA Research Ethics and Governance Group (reference NR0347). All relevant ethics guidelines will be followed throughout. Findings arising from this evaluation will be used to inform lessons learnt and recommendations for UKHSA on appropriate pandemic preparedness testing programme designs; findings will also be disseminated in peer-reviewed journals, a publicly available report to be published online and at academic conferences. The final report of findings from the evaluation will be used as part of a portfolio of evidence produced for the independent COVID-19 government inquiry in the UK.Transparency declaration The lead author (the manuscript’s guarantor) affirms that the manuscript is an honest, accurate and transparent account of the study being reported; no important aspects of the study have been omitted, and any discrepancies from the study as planned have been explained.

Abstract Background Carefully planned research is critical to developing policies and interventions that counter physical, psychological and social challenges faced by young people living with HIV/AIDS, without increasing burdens. Such studies, however, must navigate a ‘vulnerability paradox’, since including potentially vulnerable groups also risks unintentionally worsening their situation. Through embedded social science research, linked to a cohort study involving Adolescents Living with HIV/AIDS (ALH) in Kenya, we develop an account of researchers’ responsibilities towards young people, incorporating concepts of vulnerability, resilience, and agency as ‘interacting layers’. Methods Using a qualitative, iterative approach across three linked data collection phases including interviews, group discussions, observations and a participatory workshop, we explored stakeholders’ perspectives on vulnerability and resilience of young people living with HIV/AIDS, in relation to home and community, school, health care and health research participation. A total of 62 policy, provider, research, and community-based stakeholders were involved, including 27 ALH participating in a longitudinal cohort study. Data analysis drew on a Framework Analysis approach; ethical analysis adapts Luna’s layered account of vulnerability. Results ALH experienced forms of vulnerability and resilience in their daily lives in which socioeconomic context, institutional policies, organisational systems and interpersonal relations were key, interrelated influences. Anticipated and experienced forms of stigma and discrimination in schools, health clinics and communities were linked to actions undermining ART adherence, worsening physical and mental health, and poor educational outcomes, indicating cascading forms of vulnerability, resulting in worsened vulnerabilities. Positive inputs within and across sectors could build resilience, improve outcomes, and support positive research experiences. Conclusions The most serious forms of vulnerability faced by ALH in the cohort study were related to structural, inter-sectoral influences, unrelated to study participation and underscored by constraints to their agency. Vulnerabilities, including cascading forms, were potentially responsive to policy-based and interpersonal actions. Stakeholder engagement supported cohort design and implementation, building privacy, stakeholder understanding, interpersonal relations and ancillary care policies. Structural forms of vulnerability underscore researchers’ responsibilities to work within multi-sectoral partnerships to plan and implement studies involving ALH, share findings in a timely way and contribute to policies addressing known causes of vulnerabilities.

Summary: Background: Growth faltering is well-recognized during acute childhood illness and growth acceleration during convalescence, with or without nutritional therapy, may occur. However, there are limited recent data on growth after hospitalization in low- and middle-income countries. Methods: We evaluated growth following hospitalization among children aged 2–23 months in sub-Saharan Africa and South Asia. Between November 2016 and January 2019, children were recruited at hospital admission and classified as: not-wasted (NW), moderately-wasted (MW), severely-wasted (SW), or having nutritional oedema (NO). We describe earlier (discharge to 45-days) and later (45- to 180-days) changes in length-for-age [LAZ], weight-for-age [WAZ], mid-upper arm circumference [MUACZ], weight-for-length [WLZ] z-scores, and clinical, nutritional, and socioeconomic correlates. Findings: We included 2472 children who survived to 180-days post-discharge: NW, 960 (39%); MW, 572 (23%); SW, 682 (28%); and NO, 258 (10%). During 180-days, LAZ decreased in NW (−0.27 [−0.36, −0.19]) and MW (−0.23 [−0.34, −0.11]). However, all groups increased WAZ (NW, 0.21 [95% CI: 0.11, 0.32]; MW, 0.57 [0.44, 0.71]; SW, 1.0 [0.88, 1.1] and NO, 1.3 [1.1, 1.5]) with greatest gains in the first 45-days. Of children underweight (

Objective Testing for COVID-19 was a key component of the UK’s response to the COVID-19 pandemic. This strategy relied on positive individuals self-isolating to reduce transmission, making isolation the lynchpin in the public health approach. Therefore, we scoped evidence to systematically identify and categorise barriers and facilitators to compliance with self-isolation guidance during the COVID-19 pandemic in the UK, to inform public health strategies in future pandemics.Design A rapid scoping review was conducted.Search strategy Key terms were used to search literature databases (PubMed, Scopus and the WHO COVID-19 Research Database, on 7 November 2022), Google Scholar and stakeholder-identified manuscripts, ultimately including evidence published in English from UK-based studies conducted between 2020 and 2022.Data extraction and synthesis Data were extracted and synthesised into themes, organised broadly into capability, opportunity and motivation, and reviewed with key stakeholders from the UK Health Security Agency (UKHSA).Results We included 105 sources, with 63 identified from UKHSA and used to inform their decision-making during the pandemic. Influences on the decision to comply with isolation guidance were categorised into six themes: perceived ability to isolate; information and guidance; logistics; social influences, including trust; perceived value; and perceived consequences. Individuals continuously assessed these factors in deciding whether or not to comply with guidance and self-isolate.Conclusions Decisions to self-isolate after a positive test were influenced by multiple factors, including individuals’ beliefs, concerns, priorities and personal circumstances. Future testing strategies must facilitate meaningful financial, practical and mental health support to allow individuals to overcome the perceived and actual negative consequences of isolating. Clear, consistent communication of the purpose and procedures of isolating will also be critical to support compliance with self-isolation guidance, and should leverage people’s perceived value in protecting others. Building public trust is also essential, but requires investment before the next pandemic starts.

Background Medical internship is a key period for doctors’ individual career planning and also a transition period for the broader labour market. Objectives We aimed to understand the complex set of factors influencing the career intentions and decisions of junior doctors, post-internship in Kenya and Uganda. Methods We conducted semi-structured interviews with 54 junior medical officers and 14 consultants to understand doctors’ internship experiences and subsequent employment experiences. We analysed the data using a mix of a direct content approach, informed by an internship experience and career intentions framework developed primarily from high-income country literature, alongside a more inductive thematic analysis. Results Echoing the internship experience and career intentions framework, we found that clinical exposure during internship, work–life balance, aspects of workplace culture such as relationships with consultants and other team members, and concerns over future job security and professional development all influenced Kenyan and Ugandan doctors’ career preferences. Additionally, we added a new category to the framework to reflect our finding that interns might want to ‘fill a health system gap’ when they choose their future careers, based on what they witness as interns. However, often career intentions did not match career and employment decisions due to specific contextual factors, most importantly a shortage of job opportunities. Conclusion We have shown how internship experiences shape medical doctors’ career intentions in Kenya and Uganda and highlighted the importance of job availability and context in influencing doctors’ career choices.

Abstract Background Health systems are complex, consisting of multiple interacting structures and actors whose effective coordination is paramount to enhancing health system goals. Health sector coordination is a potential source of inefficiency in the health sector. We examined how the coordination of the health sector affects health system efficiency in Kenya. Methods We conducted a qualitative cross-sectional study, collecting data at the national level and in two purposely selected counties in Kenya. We collected data using in-depth interviews (n = 37) with national and county-level respondents, and document reviews. We analyzed the data using a thematic approach. Results The study found that while formal coordination structures exist in the Kenyan health system, duplication, fragmentation, and misalignment of health system functions and actor actions compromise the coordination of the health sector. These challenges were observed in both vertical (coordination within the ministry of health, within the county departments of health, and between the national ministry of health and the county department of health) and horizontal coordination mechanisms (coordination between the ministry of health or the county department of health and non-state partners, and coordination among county governments). These coordination challenges are likely to impact the efficiency of the Kenyan health system by increasing the transaction costs of health system functions. Inadequate coordination also impairs the implementation of health programmes and hence compromises health system performance. Conclusion The efficiency of the Kenyan health system could be enhanced by strengthening the coordination of the Kenyan health sector. This can be achieved by aligning and harmonizing the intergovernmental and health sector-specific coordination mechanisms, strengthening the implementation of the Kenya health sector coordination framework at the county level, and enhancing donor coordination through common funding arrangements and integrating vertical disease programs with the rest of the health system. The ministry of health and county departments of health should also review internal organizational structures to enhance functional and role clarity of organizational units and staff, respectively. Finally, counties should consider initiating health sector coordination mechanisms between counties to reduce the fragmentation of health system functions across neighboring counties.

Regulatory and other governance arrangements influence the introduction of medical devices into health systems and are essential for ensuring their effective and safe use. Challenges with medical device safety, quality and use are documented globally, with evidence suggesting these are linked to poor governance. Yet, medical device regulation and oversight remain inadequately defined and described, particularly in low-income and middle-income settings. Through this review, we sought to examine the literature available on regulatory and oversight processes for medical devices in African countries.Following a systematic approach, we searched academic databases including PubMed, Embase (Ovid) and MEDLINE (Ovid), supplemented by search for grey literature and relevant organisational websites, for documents describing medical device regulation and oversight in African countries. We summarised the data to present key actors, areas for regulation and oversight and challenges.A total of 39 documents reporting regulation and oversight of medical devices were included for analysis. Regulatory and oversight guidelines and processes were reported as inadequate, including limited pre-market testing, reliance on international certifications and limited processes for post-market monitoring and reporting of adverse events. Challenges for regulation and oversight reported included inadequate funding, personnel and technical expertise to perform regulatory functions. The literature highlighted gaps in guidelines for donated medical devices and in information on governance processes at the national level.The current literature provides a general overview of medical device regulatory guidelines and limited evidence on the implementation of regulatory/oversight processes at national and especially subnational levels. We recommend further research to elucidate existing governance arrangements for medical devices within African countries and propose a conceptual framework to inform future studies. The framework provides entry points for careful examination of governance and oversight in policy and practice, the exploration of governance realities across the health system and the influence of wider system dynamics.

BackgroundHuman resources are at the heart of health systems, playing a central role in their functionality globally. It is estimated that up to 70% of the health workforce are women, however, this pattern is not reflected in the leadership of health systems where women are under-represented. MethodsThis systematized review explored the existing literature around women’s progress towards leadership in the health sector in low- and middle-income countries (LMICs) which has used intersectional analysis. ResultsWhile there are studies that have looked at the inequities and barriers women face in progressing towards leadership positions in health systems within LMICs, none explicitly used an intersectionality framework in their approach. These studies did nevertheless show recurring barriers to health systems leadership created at the intersection of gender and social identities such as professional cadre, race/ethnicity, financial status, and culture. These barriers limit women’s access to resources that improve career development, including mentorship and sponsorship opportunities, reduce value, recognition and respect at work for women, and increase the likelihood of women to take on dual burdens of professional work and childcare and domestic work, and, create biased views about effectiveness of men and women’s leadership styles. An intersectional lens helps to better understand how gender intersects with other social identities which results in upholding these persisting barriers to career progression and leadership. ConclusionAs efforts to reduce gender inequity in health systems are gaining momentum, it is important to look beyond gender and take into account other intersecting social identities that create unique positionalities of privilege and/or disadvantage. This approach should be adopted across a diverse range of health systems programs and policies in an effort to strengthen gender equity in health and specifically human resources for health (HRH), and improve health system governance, functioning and outcomes.

Abstract Background Human resources for health consume a substantial share of healthcare resources and determine the efficiency and overall performance of health systems. Under Kenya’s devolved governance, human resources for health are managed by county governments. The aim of this study was to examine how the management of human resources for health influences the efficiency of county health systems in Kenya. Methods We conducted a case study using a mixed methods approach in two purposively selected counties in Kenya. We collected data through in-depth interviews (n = 46) with national and county level HRH stakeholders, and document and secondary data reviews. We analyzed qualitative data using a thematic approach, and quantitative data using descriptive analysis. Results Human resources for health in the selected counties was inadequately financed and there were an insufficient number of health workers, which compromised the input mix of the health system. The scarcity of medical specialists led to inappropriate task shifting where nonspecialized staff took on the roles of specialists with potential undesired impacts on quality of care and health outcomes. The maldistribution of staff in favor of higher-level facilities led to unnecessary referrals to higher level (referral) hospitals and compromised quality of primary healthcare. Delayed salaries, non-harmonized contractual terms and incentives reduced the motivation of health workers. All of these effects are likely to have negative effects on health system efficiency. Conclusions Human resources for health management in counties in Kenya could be reformed with likely positive implications for county health system efficiency by increasing the level of funding, resolving funding flow challenges to address the delay of salaries, addressing skill mix challenges, prioritizing the allocation of health workers to lower-level facilities, harmonizing the contractual terms and incentives of health workers, and strengthening monitoring and supervision.

Introduction The informal social ties that health workers form with their colleagues influence knowledge, skills and individual and group behaviours and norms in the workplace. However, improved understanding of these ‘software’ aspects of the workforce (eg, relationships, norms, power) have been neglected in health systems research. In Kenya, neonatal mortality has lagged despite reductions in other age groups under 5 years. A rich understanding of workforce social ties is likely to be valuable to inform behavioural change initiatives seeking to improve quality of neonatal healthcare.This study aims to better understand the relational components among health workers in Kenyan neonatal care areas, and how such understanding might inform the design and implementation of quality improvement interventions targeting health workers’ behaviours.Methods and analysis We will collect data in two phases. In phase 1, we will conduct non-participant observation of hospital staff during patient care and hospital meetings, a social network questionnaire with staff, in-depth interviews, key informant interviews and focus group discussions at two large public hospitals in Kenya. Data will be collected purposively and analysed using realist evaluation, interim analyses including thematic analysis of qualitative data and quantitative analysis of social network metrics. In phase 2, a stakeholder workshop will be held to discuss and refine phase one findings.Study findings will help refine an evolving programme theory with recommendations used to develop theory-informed interventions targeted at enhancing quality improvement efforts in Kenyan hospitals.Ethics and dissemination The study has been approved by Kenya Medical Research Institute (KEMRI/SERU/CGMR-C/241/4374) and Oxford Tropical Research Ethics Committee (OxTREC 519-22). Research findings will be shared with the sites, and disseminated in seminars, conferences and published in open-access scientific journals.

Summary: Background: A better understanding of which children are likely to die during acute illness will help clinicians and policy makers target resources at the most vulnerable children. We used machine learning to characterise mortality in the 30-days following admission and the 180-days after discharge from nine hospitals in low and middle-income countries (LMIC). Methods: A cohort of 3101 children aged 2–24 months were recruited at admission to hospital for any acute illness in Bangladesh (Dhaka and Matlab Hospitals), Pakistan (Civil Hospital Karachi), Kenya (Kilifi, Mbagathi, and Migori Hospitals), Uganda (Mulago Hospital), Malawi (Queen Elizabeth Central Hospital), and Burkina Faso (Banfora Hospital) from November 2016 to January 2019. To record mortality, children were observed during their hospitalisation and for 180 days post-discharge. Extreme gradient boosted models of death within 30 days of admission and mortality in the 180 days following discharge were built. Clusters of mortality sharing similar characteristics were identified from the models using Shapley additive values with spectral clustering. Findings: Anthropometric and laboratory parameters were the most influential predictors of both 30-day and post-discharge mortality. No WHO/IMCI syndromes were among the 25 most influential mortality predictors of mortality. For 30-day mortality, two lower-risk clusters (N = 1915, 61%) included children with higher-than-average anthropometry (1% died, 95% CI: 0–2), and children without signs of severe illness (3% died, 95% CI: 2–4%). The two highest risk 30-day mortality clusters (N = 118, 4%) were characterised by high urea and creatinine (70% died, 95% CI: 62–82%); and nutritional oedema with low platelets and reduced consciousness (97% died, 95% CI: 92–100%). For post-discharge mortality risk, two low-risk clusters (N = 1753, 61%) were defined by higher-than-average anthropometry (0% died, 95% CI: 0–1%), and gastroenteritis with lower-than-average anthropometry and without major laboratory abnormalities (0% died, 95% CI: 0–1%). Two highest risk post-discharge clusters (N = 267, 9%) included children leaving against medical advice (30% died, 95% CI: 25–37%), and severely-low anthropometry with signs of illness at discharge (46% died, 95% CI: 34–62%). Interpretation: WHO clinical syndromes are not sufficient at predicting risk. Integrating basic laboratory features such as urea, creatinine, red blood cell, lymphocyte and platelet counts into guidelines may strengthen efforts to identify high-risk children during paediatric hospitalisations. Funding: Bill & Melinda Gates Foundation OPP1131320.

Public Finance Management (PFM) practices influence the attainment of health system goals. PFM processes are implemented within the budget cycle which entails the formulation, execution, and monitoring of government budgets. Budget monitoring and accountability actors, structures, and processes are important in improving the efficiency of health systems. This study examined how the budget monitoring and accountability processes influence the efficiency of county health systems in KenyaWe conducted a qualitative case study of four counties in Kenya selected based on their relative technical efficiency. We collected data using in-depth interviews with health and finance stakeholders (n = 70), and document reviews. We analyzed data using a thematic approach, informed by our study conceptual framework. We found that weak budget monitoring and accountability mechanisms compromised county health system efficiency by a) weakening the effective implementation of the budget formulation and execution steps of the budget cycle, b) enabling the misappropriation of public resources, and c) limiting evidence-informed decision-making by weakening feedback that would be provided by effective monitoring and accountability. Devolution meant that accountability actors were closer to implementation actors which promoted timely problem solving and the relevance of solutions. Internal audit practices were supportive and provided useful feedback to health system managers that facilitated improvements in budget formulation and execution. The efficiency of county health systems can be improved by strengthening the budget monitoring and accountability processes. This can be achieved by increasing the population's budget literacy, supporting participatory budgeting, synchronizing performance and financial accountability, implementing the existent budget monitoring and accountability mechanisms, rewarding efficiency, and sanctioning inefficiency.

Health policy and systems research (HPSR) is a multi-disciplinary, largely applied field of research aimed at understanding and strengthening the performance of health systems, often with an emphasis on power, policy and equity. The value of embedded and participatory HPSR specifically in facilitating the collection of rich data that is relevant to addressing real-world challenges is increasingly recognised. However, the potential contributions and challenges of HPSR in the context of shocks and crises are not well documented, with a particular gap in the literature being the experiences and coping strategies of the HPSR researchers who are embedded in health systems in resource constrained settings. In this paper, we draw on two sets of group discussions held among a group of approximately 15 HPSR researchers based in Nairobi, Kenya, who were conducting a range of embedded HPSR studies throughout the COVID-19 pandemic. The researchers, including many of the authors, were employed by the KEMRI-Wellcome Trust Research Programme (KWTRP), which is a long-standing multi-disciplinary partnership between the Kenya Medical Research Institute and the Wellcome Trust with a central goal of contributing to national and international health policy and practice. We share our findings in relation to three inter-related themes: 1) Ensuring the continued social value of our HPSR work in the face of changing priorities; 2) Responding to shifting ethical procedures and processes at institutional and national levels; and 3) Protecting our own and front-line colleagues' well-being, including clinical colleagues. Our experiences highlight that in navigating research work and responsibilities to colleagues, patients and participants through the pandemic, many embedded HPSR staff faced difficult emotional and ethical challenges, including heightened forms of moral distress, which may have been better prevented and supported. We draw on our findings and the wider literature to discuss considerations for funders and research leads with an eye to strengthening support for embedded HPSR staff, not only in crises such as the on-going COVID-19 pandemic, but also more generally.

Covid-19 continues to teach the global community important lessons about preparedness for research and effective action to respond to emerging health threats. We share the COVID-19 experiences of a pre-existing cross-site ethics network-the Global Health Bioethics Network-which brings together researchers and practitioners from Africa, Europe, and Southeast Asia. We describe the network and its members and activities, and the work-related opportunities and challenges we faced over a one-year period during the pandemic. We highlight the value of having strong and long-term empirical ethics networks embedded across diverse research institutions to be able to: 1) identify and share relevant ethics challenges and research questions and ways of ’doing research’; 2) work with key stakeholders to identify appropriate ways to contribute to the emerging health issue response – e.g., through ethics oversight, community engagement, and advisory roles at different levels; and 3) learn from each other and from diverse contexts to advocate for positive change at multiple levels. It is our view that being embedded and long term offers opportunities in terms of deep institutional and contextual knowledge, existing relationships and access to a wide range of stakeholders. Being networked offers opportunities to draw upon a wide range of expertise and perspectives, and to bring together internal and external insights (i.e.drawing on different positionalities). Long term funding means that the people and resources are in place and ready to respond in a timely way. However, many tensions and challenges remain, including difficulties in negotiating power and politics in the roles that researchers and research institutions can and should play in an emergency, and the position of empirical ethics within research programmes. We discuss some of these tensions and challenges and consider the implications for our own and similar networks in future.

Abstract Background Improving health system efficiency is a key strategy to increase health system performance and accelerate progress towards Universal Health Coverage. In 2013, Kenya transitioned into a devolved system of government granting county governments autonomy over budgets and priorities. We assessed the level and determinants of technical efficiency of the 47 county health systems in Kenya. Methods We carried out a two-stage data envelopment analysis (DEA) using Simar and Wilson’s double bootstrap method using data from all the 47 counties in Kenya. In the first stage, we derived the bootstrapped DEA scores using an output orientation. We used three input variables (Public county health expenditure, Private county health expenditure, number of healthcare facilities), and one outcome variable (Disability Adjusted Life Years) using 2018 data. In the second stage, the bias corrected technical inefficiency scores were regressed against 14 exogenous factors using a bootstrapped truncated regression. Results The mean bias-corrected technical efficiency score of the 47 counties was 69.72% (95% CI 66.41–73.01%), indicating that on average, county health systems could increase their outputs by 30.28% at the same level of inputs. County technical efficiency scores ranged from 42.69% (95% CI 38.11–45.26%) to 91.99% (95% CI 83.78–98.95%). Higher HIV prevalence was associated with greater technical inefficiency of county health systems, while higher population density, county absorption of development budgets, and quality of care provided by healthcare facilities were associated with lower county health system inefficiency. Conclusions The findings from this analysis highlight the need for county health departments to consider ways to improve the efficiency of county health systems. Approaches could include prioritizing resources to interventions that will reduce high chronic disease burden, filling structural quality gaps, implementing interventions to improve process quality, identifying the challenges to absorption rates and reforming public finance management systems to enhance their efficiency.

Abstract Background Undernourished children in low- and middle-income countries remain at elevated risk of death following hospital discharge, even when treated during hospitalisation using World Health Organisation recommended guidelines. The role of community health workers (CHWs) in supporting post-discharge recovery to improve outcomes has not been adequately explored. Methods This paper draws on qualitative research conducted as part of the Childhood Acute Illnesses and Nutrition (CHAIN) Network in Bangladesh and Kenya. We interviewed family members of 64 acutely ill children admitted across four hospitals (a rural and urban hospital in each country). 27 children had severe wasting or kwashiorkor on admission. Family members were interviewed in their homes soon after discharge, and up to three further times over the following six to fourteen months. These data were supplemented by observations in facilities and homes, key informant interviews with CHWs and policy makers, and a review of relevant guidelines. Results Guidelines suggest that CHWs could play a role in supporting recovery of undernourished children post-discharge, but the mechanisms to link CHWs into post-discharge support processes are not specified. Few families we interviewed reported any interactions with CHWs post-discharge, especially in Kenya, despite our data suggesting that opportunities for CHWs to assist families post-discharge include providing context sensitive information and education, identification of danger signs, and supporting linkages with community-based services and interventions. Although CHWs are generally present in communities, challenges they face in conducting their roles include unmanageable workloads, few incentives, lack of equipment and supplies and inadequate support from supervisors and some community members. Conclusion A multi-pronged approach before or on discharge is needed to strengthen linkages between CHWs and children vulnerable to poor outcomes, supported by clear guidance. To encourage scale-ability and cost-effectiveness of interventions, the most vulnerable, high-risk children, should be targeted, including undernourished children. Intervention designs must also take into account existing health worker shortages and training levels, including for CHWs, and how any new tasks or personnel are incorporated into hospital and broader health system hierarchies and systems. Any such interventions will need to be evaluated in carefully designed studies, including tracking for unintended consequences.

Abstract Background Verbal autopsy is a pragmatic approach for generating cause-of-death data in contexts without well-functioning civil registration and vital statistics systems. It has primarily been conducted in health and demographic surveillance systems (HDSS) in Africa and Asia. Although significant resources have been invested to develop the technical aspects of verbal autopsy, ethical issues have received little attention. We explored the benefits and burdens of verbal autopsy in HDSS settings and identified potential strategies to respond to the ethical issues identified. Methods This research was based on a case study approach centred on two contrasting HDSS in Kenya and followed the Mapping-Framing-Shaping Framework for empirical bioethics research. Data were collected through individual interviews, focus group discussions, document reviews and non-participant observations. 115 participants were involved, including 86 community members (HDSS residents and community representatives), and 29 research staff (HDSS managers, researchers, census field workers and verbal autopsy interviewers). Results The use of verbal autopsy data for research and public health was described as the most common potential benefit of verbal autopsy in HDSS. Community members mentioned the potential uses of verbal autopsy data in addressing immediate public health problems for the local population while research staff emphasized the benefits of verbal autopsy to research and the wider public. The most prominent burden associated with the verbal autopsy was emotional distress for verbal autopsy interviewers and respondents. Moral events linked to the interview, such as being unsure of the right thing to do (moral uncertainty) or knowing the right thing to do and being constrained from acting (moral constraint), emerged as key causes of emotional distress for verbal autopsy interviewers. Conclusions The collection of cause-of-death data through verbal autopsy in HDSS settings presents important ethical and emotional challenges for verbal autopsy interviewers and respondents. These challenges include emotional distress for respondents and moral distress for interviewers. This empirical ethics study provides detailed accounts of the distress caused by verbal autopsy and highlights ethical tensions between potential population benefits and risks to individuals. It includes recommendations for policy and practice to address emotional and moral distress in verbal autopsy.

There has been a steady increase in health research capacity strengthening (HRCS) consortia and programmes. However, their structures and management practices and the effect on the capacity strengthening outcomes have been underexamined. We conducted a case study involving three HRCS consortia where we critically examined the consortia’s decision-making processes, strategies for resolving management tensions and the potential implications for consortia outcomes. We conducted 44 in-depth interviews with a range of consortia members and employed the framework method to analyse the data. We assessed the extent to which consortia’s management practices and strategies enabled or hindered research capacity strengthening using a capacity development lens. At the heart of consortium management is how tensions are navigated and the resolution strategies adopted. This study demonstrates that the management strategies adopted by consortia have capacity strengthening consequences. When deciding on tension management strategies, trade-offs often occur, sometimes to the detriment of capacity strengthening aims. When management strategies align with capacity development principles, consortium management processes become capacity strengthening mechanisms for participating individuals and institutions. Such alignment enhances programme effectiveness and value for money. Drawing on these findings, we propose an evidence-informed management framework that consortia leaders can use in practice to support decision-making to optimise research capacity gains. Considering the increasing investment in HRCS consortia, leveraging all consortium processes towards capacity strengthening will maximise the returns on investments made.

Introduction: Effective communication is essential to delivering compassionate, high-quality nursing care. The intensive, stressful and technical environment of a new-born unit (NBU) in a low-resource setting presents communication-related challenges for nurses, with negative implications for nurse well-being, team relationships and patient care. We adapted a pre-existing communication and emotional competence course with NBU nurse managers working in Kenya, explored its’ value to participants and developed a theory of change to evaluate its’ potential impact. Methods: 18 neonatal nurse managers from 14 county referral hospitals helped adapt and participated in a nine-month participatory training process. Training involved guided ‘on the job’ self-observation and reflection to build self-awareness, and two face-to-face skills-building workshops. The course and potential for future scale up was assessed using written responses from participant nurses (baseline questionnaires, reflective assignments, pre and post workshop questionnaires), workshop observation notes, two group discussions and nine individual in-depth interviews. Results: Participants were extremely positive about the course, with many emphasizing its direct relevance and applicability to their daily work. Increased self-awareness and ability to recognize their own, colleagues’ and patients’ emotional triggers, together with new knowledge and practical skills, reportedly inspired nurses to change; in turn influencing their ability to provide respectful care, improving their confidence and relationships and giving them a stronger sense of professional identity. Conclusion: Providing respectful care is a major challenge in low-resource, high-pressure clinical settings but there are few strategies to address this problem. The participatory training process examined addresses this challenge and has potential for positive impacts for families, individual workers and teams, including worker well-being. We present an initial theory of change to support future evaluations aimed at exploring if and how positive gains can be sustained and spread within the wider system.

Background: The scale of the COVID-19 pandemic and novelty of SARS-CoV-2 presented unprecedented challenges in the review of COVID-19 protocols. We investigated how research at the KEMRI Wellcome Trust Research Programme (KWTRP) was reviewed, including by institutional and national level committees. Methods: A document review and in-depth interviews with researchers, regulators and research reviewers were conducted. Documents reviewed included research logs of all protocols submitted between April-1-2020 and March-31-2021, feedback letters from review committees for 10 new COVID-19 protocols (n=42), and minutes from 35 COVID-19 research review meetings. Fifteen in-depth interviews were conducted with respondents purposively selected because of their experience of developing or reviewing COVID-19 protocols at the institution level (n=9 researchers, engagement officers and regulators) or their experience in reviewing proposals at a national-level (n=6 committee members). Data were managed and analyzed using MS Excel and NVivo12. Results: Between April-1-2020 and March-31-2021, 30 COVID-19-related submissions by KWTRP researchers were approved. Changes to the review system included strengthening the online system for protocol submission and review, recruiting more reviewers, and trialing a joint review process where one protocol was submitted to multiple review committees simultaneously . The turnaround time from submission to national approval/rejection over this period was faster than pre-pandemic, but slower than the national committee’s target. COVID-19-specific ethics questions centred on: virtual informed consent and data collection; COVID-19 prevention, screening and testing procedures; and the challenges of study design and community engagement during the pandemic. Conclusions: The unprecedented challenges of the pandemic and added bureaucratic requirements created a more complex review process and delayed final approval of research protocols. The feasibility of conducting joint review of research during public health emergencies in Kenya needs further investigation. Consideration of the unique COVID-19 ethics issues raised in this paper might aid expedience in current and future reviews.

Abstract Background The World Health Organisation framed responsiveness, fair financing and equity as intrinsic goals of health systems. However, of the three, responsiveness received significantly less attention. Responsiveness is essential to strengthen systems’ functioning; provide equitable and accountable services; and to protect the rights of citizens. There is an urgency to make systems more responsive, but our understanding of responsiveness is limited. We therefore sought to map existing evidence on health system responsiveness. Methods A mixed method systemized evidence mapping review was conducted. We searched PubMed, EbscoHost, and Google Scholar. Published and grey literature; conceptual and empirical publications; published between 2000 and 2020 and English language texts were included. We screened titles and abstracts of 1119 publications and 870 full texts. Results Six hundred twenty-one publications were included in the review. Evidence mapping shows substantially more publications between 2011 and 2020 (n = 462/621) than earlier periods. Most of the publications were from Europe (n = 139), with more publications relating to High Income Countries (n = 241) than Low-to-Middle Income Countries (n = 217). Most were empirical studies (n = 424/621) utilized quantitative methodologies (n = 232), while qualitative (n = 127) and mixed methods (n = 63) were more rare. Thematic analysis revealed eight primary conceptualizations of ‘health system responsiveness’, which can be fitted into three dominant categorizations: 1) unidirectional user-service interface; 2) responsiveness as feedback loops between users and the health system; and 3) responsiveness as accountability between public and the system. Conclusions This evidence map shows a substantial body of available literature on health system responsiveness, but also reveals evidential gaps requiring further development, including: a clear definition and body of theory of responsiveness; the implementation and effectiveness of feedback loops; the systems responses to this feedback; context-specific mechanism-implementation experiences, particularly, of LMIC and fragile-and conflict affected states; and responsiveness as it relates to health equity, minority and vulnerable populations. Theoretical development is required, we suggest separating ideas of services and systems responsiveness, applying a stronger systems lens in future work. Further agenda-setting and resourcing of bridging work on health system responsiveness is suggested.

Abstract Background Post-hospital discharge mortality risk is high among young children in many low and middle-income countries (LMICs). The available literature suggests that child, caregiver and health care provider gender all play important roles in post-discharge adherence to medical advice, treatment-seeking and recovery for ill children in LMICs, including those with undernutrition. Methods A qualitative study was embedded within a larger multi-country multi-disciplinary observational cohort study involving children aged less than 2 years conducted by the Childhood Acute Illness and Nutrition (CHAIN) Network. Primary data were collected from family members of 22 purposively selected cohort children. Family members were interviewed several times in their homes over the 6 months following hospital discharge (total n = 78 visits to homes). These in-depth interviews were complemented by semi-structured individual interviews with 6 community representatives, 11 community health workers and 12 facility-based health workers, and three group discussions with a total of 24 community representatives. Data were analysed using NVivo11 software, using both narrative and thematic approaches. Results We identified gender-related influences at health service/system and household/community levels. These influences interplayed to family members’ adherence to medical advice and treatment-seeking after hospital discharge, with potentially important implications for children’s recovery. Health service/system level influences included: fewer female medical practitioners in healthcare facilities, which influenced mothers’ interest and ability to consult them promptly for their child’s illnesses; gender-related challenges for community health workers in supporting mothers with counselling and advice; and male caregivers’ being largely absent from the paediatric wards where information sessions to support post-discharge care are offered. Gendered household/community level influences included: women’s role as primary caretakers for children and available levels of support; male family members having a dominant role in decision-making related to food and treatment-seeking behaviour; and greater reluctance among parents to invest money and time in the treatment of female children, as compared to male children. Conclusions A complex web of gender related influences at health systems/services and household/community levels have important implications for young children’s recovery post-discharge. Immediate interventions with potential for positive impact include awareness-raising among all stakeholders – including male family members - on how gender influences child health and recovery, and how to reduce adverse consequences of gender-based discrimination. Specific interventions could include communication interventions in facilities and homes, and changes in routine practices such as who is present in facility interactions. To maximise and sustain the impact of immediate actions and interventions, the structural drivers of women’s position in society and gender inequity must also be tackled. This requires interventions to ensure equal equitable opportunities for men and women in all aspects of life, including access to education and income generation activities. Given patriarchal norms locally and globally, men will likely need special targeting and support in achieving these objectives.

Abstract Background In many African settings, gender strongly influences household treatment-seeking and decision-making for childhood illnesses. While mothers are often the primary engagers with health facilities, their independence in illness-related decisions is shaped by various factors. Drawing on a gender lens, we explored treatment-seeking pathways pre- and post-hospital admission for acutely ill young children living in low income settlements in Nairobi, Kenya; and the gendered impact of child illness both at the household and health system level. Methods Household members of 22 children admitted to a public hospital were interviewed in their homes several times post hospital discharge. In-depth interviews covered the child’s household situation, health and illness; and the family’s treatment-seeking choices and experiences. Children were selected from an observational cohort established by the Childhood Acute Illness and Nutrition (CHAIN) Network. Results Treatment-seeking pathways were often long and complex, with mothers playing the key role in caring for their children and in treatment decision-making. Facing many anxieties and dilemmas, mothers often consulted with significant influencers - primarily women - particularly where illnesses were prolonged or complex. In contrast to observations in rural African contexts, fathers were less prominent as influencers than (often female) neighbours, grandparents and other relatives. Mothers were sometimes blamed for their child’s condition at home and at health facilities. Children’s illness episode and associated treatment-seeking had significant gendered socio-economic consequences for households, including through mothers having to take substantial time off work, reduce their working hours and income, or even losing their jobs. Conclusion Women in urban low-income settings are disproportionately impacted by acute child illness and the related treatment-seeking and recovery process. The range of interventions needed to support mothers as they navigate their way through children’s illnesses and recovery include: deliberate engagement of men in child health to counteract the dominant perception of child health and care as a ‘female-domain’; targeted economic strategies such as cash transfers to safeguard the most vulnerable women and households, combined with more robust labour policies to protect affected women; as well as implementing strategies at the health system level to improve interactions between health workers and community members.

Background: Global efforts to strengthen health research capacity in low- and middle-income countries (LMICs) have intensified in the past few decades, and these efforts are often implemented by consortia. Our review of the literature indicated that reports on health research capacity strengthening (HRCS) consortia have primarily focused on programme outputs and outcomes while management processes and their contributions to consortia goals have received little attention. This qualitative study sought to identify the consortium management processes employed by 10 DELTAS Africa consortia, factors influencing these processes, and leaders’ consortium management experiences. Methods: We conducted 24 key informant interviews with the directors and programme managers of all the 10 DELTAS Africa consortia, and funding actors who worked closely with the consortia. The interviews were supplemented by reviews of DELTAS and consortium-specific documents. Data were analysed using the content analysis approach. Results: The consortia studied employed similar management processes but adopted different strategies in executing these processes. Study results indicate that decision-making in consortia is not always a straightforward process as leaders were often faced with dilemmas when determining management strategies to adopt, and often tried to balance multiple factors which were not always aligned. This was demonstrated as consortia selected partners, determined goals and activities, assigned roles and responsibilities, allocated resources, established governance and partner management systems, and coordinated and monitored consortia activities. Factors that influenced the choice of processes and approaches included previous experiences, funders expectations, and the pressure to deliver research outputs. Consortia’s unique approaches to management were due to varying contexts and influences and indicate that management decisions are nuanced and cannot easily be formularized. Conclusion: The study has highlighted the importance of flexibility in consortium management and the need to generate research capacity strengthening (RCS)-specific guidance that can assist consortia in resolving dilemmas and making appropriate management decisions.

Abstract Background Health service delivery should ensure ethical principles are observed at all levels of healthcare. Working towards this goal requires understanding the ethics-related priorities and concerns in the day-to-day activities among different health practitioners. These practitioners include community health workers (CHWs) who are involved in healthcare delivery in communities in many low-and middle-income countries such as Uganda. In this study, we used photovoice, an innovative community based participatory research method that uses photography, to examine CHWs' perspectives on ethical concerns in their work. Methods We explored perspectives of 10 CHWs (5 females and 5 males) on ethical dimensions of their work for 5 months using photovoice in a rural community in Wakiso district, Uganda. As part of the study, we: 1. Oriented CHWs on photovoice research and ethics; 2. Asked CHWs to take photographs of key ethical dimensions of their work; 3. Held monthly meetings to discuss and reflect on the photos; and 4. Disseminated the findings. The discussions from the monthly meetings were audio recorded, transcribed, and emerging data analysed using conventional content analysis with the help of Atlas ti version 6.0.15. Results CHWs were aware of and highly concerned about the need to observe ethical principles while carrying out their roles. The ethical principles CHWs were aware of and endeavoured to observe during their work were: maintaining professional integrity and abiding by ethical principles of practice; ethical responsibility in patient care; maintaining confidentiality while handling clients; respect for persons and communities; and enhancing their knowledge and skills for better practice. However, CHWs also identified challenges concerning their observance of ethical principles including: low commitment to their work due to other obligations; availability of some reference materials and guidelines in English yet majority could only read in the local language; and minimal avenues for knowledge enhancement such as trainings. Conclusions CHWs were aware of and keen to discuss ethical issues in their work. However, there is need to address the challenges they face so as to facilitate observing ethical principles during the course of their work in communities.

Abstract Background Child mortality rates during hospitalisation for acute illness and after discharge are unacceptably high in many under-resourced settings. Childhood vulnerability to recurrent illness, and death, is linked to their families’ situations and ability to make choices and act (their agency). We examined vulnerability and agency across treatment-seeking journeys for acutely ill children and considered the implications for policy and practice. Method A qualitative sub-study was embedded within the prospective CHAIN Network cohort study, which is investigating mechanisms of inpatient and post-hospital discharge mortality among acutely ill young children across a spectrum of nutritional status. Primary data were collected from household members of 20 purposively selected cohort children over 18 months through formal interviews (total n = 74), complemented by informal discussions and observations. Data were analysed using narrative and thematic approaches. Results Treatment-seeking pathways were often long and complex, particularly for children diagnosed as severely malnourished. Family members’ stories reveal that children’s carers, usually mothers, navigate diverse challenges related to intersecting vulnerabilities at individual, household and facility levels. Specific challenges include the costs of treatment-seeking, confusing and conflicting messaging on appropriate care and nutrition, and poor continuity of care. Strong power inequities were observed between family members and health staff, with many mothers feeling blamed for their child’s condition. Caregivers’ agency, as demonstrated in decision-making and actions, often drew on the social support of others but was significantly constrained by their situation and broader structural drivers. Conclusion To support children’s care and recovery, health systems must be more responsive to the needs of families facing multiple and interacting vulnerabilities. Reducing incurred treatment costs, improving interpersonal quality of care, and strengthening continuity of care across facilities is essential. Promising interventions need to be co-designed with community representatives and health providers and carefully tested for unintended negative consequences and potential for sustainable scale-up.

Abstract Background While health worker strikes are experienced globally, the effects can be worst in countries with infrastructural and resource challenges, weak institutional arrangements, underdeveloped organizational ethics codes, and unaffordable alternative options for the poor. In Kenya, there have been a series of public health worker strikes in the post devolution period. We explored the perceptions and experiences of frontline health managers and community members of the 2017 prolonged health workers’ strikes. Methods We employed an embedded research approach in one county in the Kenyan Coast. We collected in-depth qualitative data through informal observations, reflective meetings, individual and group interviews and document reviews (n = 5), and analysed the data using a thematic approach. Individual interviews were held with frontline health managers (n = 26), and group interviews with community representatives (4 health facility committee member groups, and 4 broader community representative groups). Interviews were held during and immediately after the nurses’ strike. Findings In the face of major health facility and service closures and disruptions, frontline health managers enacted a range of strategies to keep key services open, but many strategies were piecemeal, inconsistent and difficult to sustain. Interviewees reported huge negative health and financial strike impacts on local communities, and especially the poor. There is limited evidence of improved health system preparedness to cope with any future strikes. Conclusion Strikes cannot be seen in isolation of the prevailing policy and health systems context. The 2017 prolonged strikes highlight the underlying and longer-term frustration amongst public sector health workers in Kenya. The health system exhibited properties of complex adaptive systems that are interdependent and interactive. Reactive responses within the public system and the use of private healthcare led to limited continued activity through the strike, but were not sufficient to confer resilience to the shock of the prolonged strikes. To minimise the negative effects of strikes when they occur, careful monitoring and advanced planning is needed. Planning should aim to ensure that emergency and other essential services are maintained, threats between staff are minimized, health worker demands are reasonable, and that governments respect and honor agreements.

Background: Community engagement (CE) is increasingly accepted as a critical aspect of health research, because of its potential to make research more ethical, relevant and well implemented. While CE activities linked to health research have proliferated in Low and Middle Income Countries (LMICs), and are increasingly described in published literature, there is a lack of conceptual clarity around how engagement is understood to ‘work’, and the aims and purposes of engagement are varied and often not made explicit. Ultimately, the evidence base for engagement remains underdeveloped. Methods: To develop explanations for how and why CE with health research contributes to the pattern of outcomes observed in published literature, we conducted a realist review of CE with malaria research – a theory driven approach to evidence synthesis. Results: We found that community engagement relies on the development of provisional ‘working relationships’ across differences, primarily of wealth, power and culture. These relationships are rooted in interactions that are experienced as relatively responsive and respectful, and that bring tangible research related benefits. Contextual factors affecting development of working relationships include the facilitating influence of research organisation commitment to and resources for engagement, and constraining factors linked to the prevailing ‘dominant health research paradigm context’, such as: differences of wealth and power between research centres and local populations and health systems; histories of colonialism and vertical health interventions; and external funding and control of health research. Conclusions: The development of working relationships contributes to greater acceptance and participation in research by local stakeholders, who are particularly interested in research related access to health care and other benefits. At the same time, such relationships may involve an accommodation of some ethically problematic characteristics of the dominant health research paradigm, and thereby reproduce this paradigm rather than challenge it with a different logic of collaborative partnership.

IntroductionPost-hospital discharge mortality is high among undernourished children in many low and middle-income countries. Although a number of quantitative studies have highlighted a range of potential socio-cultural, economic and health system factors influencing paediatric post-discharge treatment-seeking and recovery, few studies have explored family and provider perspectives of the post-discharge period in-depth.MethodsThis work was part of a large, multi-country prospective cohort study, the Childhood Acute Illness and Nutrition (CHAIN) Network. We conducted a qualitative sub-study to understand the post-discharge treatment-seeking and recovery experiences of families of undernourished children aged 2-23 months admitted in a rural and urban icddr,b (International Centre for Diarrhoeal Disease Research, Bangladesh) hospital. Methods included repeat in-depth interviews (73 interviews in total) with 29 family members of 17 purposively selected children. These data were supplemented by interviews with 33 health workers, and by observations in hospitals and homes.ResultsImportant drivers of treatment-seeking perceived to support recovery included advice provided to family members while in hospital, media campaigns on hygiene practice, availability of free treatment, and social and financial support from family members, relatives and neighbours. Key perceived challenges included low household incomes, mothers having to juggle multiple responsibilities in addition to caring for the sick child, lack of support (sometimes violence) from the child's father, and family members' preference for relatively accessible drug shops, physicians or healers over hospital admission.ConclusionDevelopment of interventions that address the challenges that families face is essential to support post-discharge adherence to medical advice and recovery. Potential interventions include strengthening information giving during hospitalization on what post-discharge care is needed and why, reducing direct and indirect costs associated with hospital visits, engaging fathers and other 'significant others' in post-discharge advice, and building mobile phone-based support for follow-up care.

Abstract Background Routine health information systems can provide near real-time data for malaria programme management, monitoring and evaluation, and surveillance. There are widespread concerns about the quality of the malaria data generated through routine information systems in many low-income countries. However, there has been little careful examination of micro-level practices of data collection which are central to the production of routine malaria data. Methods Drawing on fieldwork conducted in two malaria endemic sub-counties in Kenya, this study examined the processes and practices that shape routine malaria data generation at frontline health facilities. The study employed ethnographic methods—including observations, records review, and interviews—over 18-months in four frontline health facilities and two sub-county health records offices. Data were analysed using a thematic analysis approach. Results Malaria data generation was influenced by a range of factors including human resource shortages, tool design, and stock-out of data collection tools. Most of the challenges encountered by health workers in routine malaria data generation had their roots in wider system issues and at the national level where the framing of indicators and development of data collection tools takes place. In response to these challenges, health workers adopted various coping mechanisms such as informal task shifting and use of improvised tools. While these initiatives sustained the data collection process, they also had considerable implications for the data recorded and led to discrepancies in data that were recorded in primary registers. These discrepancies were concealed in aggregated monthly reports that were subsequently entered into the District Health Information Software 2. Conclusion Challenges to routine malaria data generation at frontline health facilities are not malaria or health information systems specific; they reflect wider health system weaknesses. Any interventions seeking to improve routine malaria data generation must look beyond just malaria or health information system initiatives and include consideration of the broader contextual factors that shape malaria data generation.

Background: Informal payments limit equitable access to healthcare. Despite being a common phenomenon, there is a need for an in-depth analysis of informal charging practices in the Sub-Saharan Africa (SSA) context. We conducted a systematic literature review to synthesize existing evidence on the prevalence, characteristics, associated factors, and impact of informal payments in SSA. Methods: We searched for literature on PubMed, African Index Medicus, Directory of Open Access Journals, and Google Scholar databases and relevant organizational websites. We included empirical studies on informal payments conducted in SSA regardless of the study design and year of publication and excluded reviews, editorials, and conference presentations. Framework analysis was conducted, and the review findings were synthesized. Results: A total of 1700 articles were retrieved, of which 23 were included in the review. Several studies ranging from large-scale nationally representative surveys to in-depth qualitative studies have shown that informal payments are prevalent in SSA regardless of the health service, facility level, and sector. Informal payments were initiated mostly by health workers compared to patients and they were largely made in cash rather than in kind. Patients made informal payments to access services, skip queues, receive higher quality of care, and express gratitude. The poor and people who were unaware of service charges, were more likely to pay informally. Supply-side factors associated with informal payments included low and irregular health worker salaries, weak accountability mechanisms, and perceptions of widespread corruption in the public sector. Informal payments limited access especially among the poor and the inability to pay was associated with delayed or forgone care and provision of lower-quality care. Conclusions: Addressing informal payments in SSA requires a multifaceted approach. Potential strategies include enhancing patient awareness of service fees, revisiting health worker incentives, strengthening accountability mechanisms, and increasing government spending on health.

Health research in low-resource settings often involves individuals and populations defined as ‘vulnerable’. There is growing attention in the literature to the ethical dilemmas that frontline research staff face while conducting such research. However, there is little documented as to how research staff might support one another in identifying and handling these dilemmas in different contexts. Over the course of conducting empirical ethics research embedded in the Childhood Acute Illness & Nutrition Network, we developed an approach to examine and respond to the ethical issues and dilemmas faced by the study teams, particularly frontline staff. In this paper we describe the specific tools and approach we developed, which centred on regular cross-team ethics reflection sessions, and share lessons learnt. We suggest that all studies involving potentially vulnerable participants should incorporate activities and processes to support frontline staff in identifying, reflecting on and responding to ethical dilemmas, throughout studies. We outline the resources needed to do this and share piloted tools for further adaptation and evaluation. Such initiatives should complement and feed into—and certainly not in any way replace or substitute for—strong institutional ethics review, safeguarding and health and safety policies and processes, as well broader staff training and career support initiatives.

Abstract Background International research guidance has shifted towards an increasingly proactive inclusion of children and adolescents in health research in recognition of the need for more evidence-based treatment. Strong calls have been made for the active involvement of children and adolescents in developing research proposals and policies, including in decision-making about research participation. Much evidence and debate on this topic has focused on high-income settings, while the greatest health burdens and research gaps occur in low-middle income countries, highlighting the need to take account of voices from more diverse contexts. Methods Between January and March 2014, 56 community representatives and secondary school students were involved in eight group discussions to explore views on the acceptability of involving children and adolescents in research, and how these groups should be involved in decision-making about their own participation. Discussions were voice-recorded and transcriptions analyzed using Framework Analysis, combining deductive and inductive approaches. Results Across these discussions, the idea of involving children and adolescents in decision-making about research participation was strongly supported given similar levels of responsibility carried in everyday life; existing capacity that should be recognized; the opportunity for learning involved; varying levels of parental control; and generational shifts towards greater understanding of science for adolescents than their parents. Joint decision-making processes were supported for older children and adolescents, with parental control influenced by perceptions of the risks involved in participation. Conclusions Moves towards more active involvement of children and adolescents in planning studies and in making decisions about their participation are supported by these findings from Kenya. Important emerging considerations include the need to take account of the nature of proposed studies and prevailing attitudes and understanding of research in identifying children’s and adolescents’ roles. More research is needed to expand diversity and develop approaches to joint assent and consent processes that would fairly represent children’s and adolescents’ wishes and interests, towards their long term benefit.

Abstract Background Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role and form of information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. Methods We conducted a qualitative study on the role of information sharing and governance processes for inpatient data re-use, using in-depth interviews with 34 health stakeholders at two public hospitals on the Kenyan coast, including health managers, providers and researchers. Data were collected between March and July 2016 and analysed using a framework approach, with Nvivo 10 software to support data management. Results Most forms of clinical data re-use were seen as an important public health good. Individual consent and general notification processes were often argued as important, but contingent on interrelated influences of the type of data, use and secondary user. Underlying concerns were linked to issues of patient privacy and autonomy; perceived risks to trust in health systems; and fairness in how data would be used, particularly for non-public sector re-users. Support for engagement often turned on the anticipated outcomes of information-sharing processes, as building or undermining trust in healthcare systems. Conclusions As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs.

In this research note we reflect on our failed attempt to synthesize the community engagement literature through a standard systematic review and explain our rationale for now embarking on a realist synthesis of community engagement in global health research. We believe this paper will be helpful for many who grapple with the lack of clarity about community engagement’s core elements and mechanisms.

Efficiency gains is a potential strategy to expand Kenya's fiscal space for health. We explored health sector stakeholders' understanding of efficiency and their perceptions of the factors that influence the efficiency of county health systems in Kenya. We conducted a qualitative cross-sectional study and collected data using three focus group discussions during a stakeholder engagement workshop. Workshop participants included health sector stakeholders from the national ministry of health and 10 (out 47) county health departments, and non-state actors in Kenya. A total of 25 health sector stakeholders participated. We analysed data using a thematic approach. Health sector stakeholders indicated the need for the outputs and outcomes of a health system to be aligned to community health needs. They felt that both hardware aspects of the system (such as the financial resources, infrastructure, human resources for health) and software aspects of the system (such as health sector policies, public finance management systems, actor relationships) should be considered as inputs in the analysis of county health system efficiency. They also felt that while traditional indicators of health system performance such as intervention coverage or outcomes for infectious diseases, and reproductive, maternal, neonatal and child health are still relevant, emerging epidemiological trends such as an increase in the burden of non-communicable diseases should also be considered. The stakeholders identified public finance management, human resources for health, political interests, corruption, management capacity, and poor coordination as factors that influence the efficiency of county health systems. An in-depth examination of the factors that influence the efficiency of county health systems could illuminate potential policy levers for generating efficiency gains. Mixed methods approaches could facilitate the study of both hardware and software factors that are considered inputs, outputs or factors that influence health system efficiency. County health system efficiency in Kenya could be enhanced by improving the timeliness of financial flows to counties and health facilities, giving health facilities financial autonomy, improving the number, skill mix, and motivation of healthcare staff, managing political interests, enhancing anticorruption strategies, strengthening management capacity and coordination in the health sector.

Introduction Health and Demographic Surveillance Systems (HDSS) collect data on births, deaths and migration from relatively small, geographically defined populations primarily in Africa and Asia. HDSS occupy a grey area between research, healthcare and public health practice and it is unclear how ethics guidance that rely on a research-practice distinction apply to HDSS. This topic has received little attention in the literature. In this paper, based on empirical research across sub-Saharan Africa, we map out key ethical issues for HDSS and assess the relevance of current ethics guidance in relation to these findings.Methods We conducted a qualitative study across seven HDSS sites in sub-Saharan Africa, including individual in-depth interviews and informal discussions with 68 research staff, document reviews and non-participant observations of surveillance activities. Qualitative data analysis drew on a framework approach led by a priori and emergent themes, drawing on the wider ethics and social science literature.Results There were diverse views on core ethical issues in HDSS, including regarding the strengths and challenges of community engagement, informed consent and data sharing processes. A key emerging issue was unfairness in the overall balance of benefits and burdens for residents and front-line staff when compared with other stakeholders, particularly given the socioeconomic contexts in which HDSS are generally conducted.Conclusion We argue that HDSS operate as non-traditional epidemiologic research projects but are often governed using ethics guidance developed for traditional forms of health research. There is a need for specific ethics guidance for HDSS which prioritises considerations around fairness, cost-effectiveness, ancillary care responsibilities, longitudinality and obligations of the global community to HDSS residents.

BackgroundChild mortality rates remain unacceptably high in low-resource settings. Cause of death (CoD) is often unknown. Minimally invasive tissue sampling (MITS)-using biopsy needles to obtain post-mortem samples-for histopathological and microbiologic investigation is increasingly being promoted to improve child and adult CoD attribution. "MITS in Malawi" is a sub-study of the Childhood Acute Illness & Nutrition (CHAIN) Network, which aims to identify biological and socioeconomic mortality risk factors among young children hospitalized for acute illness or undernutrition. MITS in Malawi employs standard MITS and a novel post-mortem endoscopic intestinal sampling approach to better understand CoD among children with acute illness and/or malnutrition who die during hospitalization.AimTo understand factors that may impact MITS acceptability and inform introduction of the procedure to ascertain CoD among children with acute illness or malnutrition who die during hospitalization in Malawi.MethodsWe conducted eight focus group discussions with key hospital staff and community members (religious leaders and parents of children under 5) to explore attitudes towards MITS and inform consent processes prior to commencing the MITS in Malawi study. We used thematic content analysis drawing on a conceptual framework developed from emergent themes and MITS acceptability literature.ResultsFeelings of power over decision-making within the hospital and household, trust in health systems, and open and respectful health worker communication with parents were important dimensions of MITS acceptability. Other facilitating factors included the potential for MITS to add CoD information to aid sense-making of death and contribute to medical knowledge and new interventions. Potential barriers to acceptability included fears of organ and blood harvesting, disfigurement to the body, and disruption to transportation and burial plans.ConclusionSocial relationships and power dynamics within healthcare systems and households are a critical component of MITS acceptability, especially given the sensitivity of death and autopsy.

In low and middle-income countries (LMIC) general hospitals are important for delivering some key acute care services. Neonatal care is emblematic of these acute services as averting deaths requires skilled care over many days from multiple professionals with at least basic equipment. However, hospital care is often of poor quality and large-scale change is needed to improve outcomes. In this manuscript we aim to show how we have drawn upon our understanding of contexts of care in Kenyan general hospital NBUs, and on social and behavioural theories that offer potential mechanisms of change in these settings, to develop an initial programme theory guiding a large scale change intervention to improve neonatal care and outcomes. Our programme theory is an expression of our assumptions about what actions will be both useful and feasible. It incorporates a recognition of our strengths and limitations as a research-practitioner partnership to influence change. The steps we employ represent the initial programme theory development phase commonly undertaken in many Realist Evaluations. However, unlike many Realist Evaluations that develop initial programme theories focused on pre-existing interventions or programmes, our programme theory informs the design of a new intervention that we plan to execute. Within this paper we articulate briefly how we propose to operationalise this new intervention. Finally, we outline the quantitative and qualitative research activities that we will use to address specific questions related to the delivery and effects of this new intervention, discussing some of the challenges of such study designs. We intend that this research on the intervention will inform future efforts to revise the programme theory and yield transferable learning.

In low and middle-income countries (LMIC) general hospitals are important for delivering some key acute care services. Neonatal care is emblematic of these acute services as averting deaths requires skilled care over many days from multiple professionals with at least basic equipment. However, hospital care is often of poor quality and large-scale change is needed to improve outcomes. However, achieving large scale change in health systems remains challenging. To set the scene we first characterise the problems of hospital newborn units (NBU) in Kenya. We then combine our understanding of theory and context with reflection on our own position as an embedded research group with no formal authority to help us propose a feasible intervention strategy linked to in initial programme theory. We explain this programme theory and suggest how within a multi-level clinical professional network leaders at the ward or mid-level of hospital hierarchies are key potential change agents. In support of our programme theory we briefly outline and seek to integrate key ideas drawn from a wider set of theories. We propose how an intervention might be developed and employed in a phased approach to create the ownership, relationships and momentum that will be needed to achieve change at scale. Finally, we discuss the implications of such a strategy for our research design that is based on a prospective, in-depth case study that includes quantitative and qualitative data collection linked to specific sub-studies. We suggest using Realistic Evaluation to integrate our findings and develop an updated programme theory that should inform future large-scale change efforts before briefly discussing some of the challenges of evaluating a network as an intervention

Health policy and systems research (HPSR) is increasingly being funded and conducted worldwide. There are currently no specific guidelines or criteria for the ethical review and conduct of HPSR. Academic debates on HPSR ethics in the scholarly literature can inform the development of guidelines. Yet there is a deficiency of academic bioethics work relating to justice in HPSR. This gap is especially problematic for a field like HPSR, which can entail studies that intervene in ways affecting the social and health system delivery structures of society. In this paper, we call for interpreting the principle of justice in a more expansive way in developing and reviewing HPSR studies (relative to biomedical research). The principle requires advancing health equity and social justice at population or systems levels. Drawing on the rich justice literature from political philosophy and public health ethics, we propose a set of essential justice considerations to uphold this principle. These considerations are relevant for research funders, researchers, research ethics committees, policymakers, community organisations and others who are active in the HPSR field.

There are global calls for research to support health system strengthening in low-income and middle-income countries (LMICs). To examine the nature and magnitude of gaps in access and quality of inpatient neonatal care provided to a largely poor urban population, we combined multiple epidemiological and health services methodologies. Conducting this work and generating findings was made possible through extensive formal and informal stakeholder engagement linked to flexibility in the research approach while keeping overall goals in mind. We learnt that 45% of sick newborns requiring hospital care in Nairobi probably do not access a suitable facility and that public hospitals provide 70% of care accessed with private sector care either poor quality or very expensive. Direct observations of care and ethnographic work show that critical nursing workforce shortages prevent delivery of high-quality care in high volume, low-cost facilities and likely threaten patient safety and nurses’ well-being. In these challenging settings, routines and norms have evolved as collective coping strategies so health professionals maintain some sense of achievement in the face of impossible demands. Thus, the health system sustains a functional veneer that belies the stresses undermining quality, compassionate care. No one intervention will dramatically reduce neonatal mortality in this urban setting. In the short term, a substantial increase in the number of health workers, especially nurses, is required. This must be combined with longer term investment to address coverage gaps through redesign of services around functional tiers with improved information systems that support effective governance of public, private and not-for-profit sectors.

Abstract Background Practices of power lie at the heart of policy processes. In both devolution and priority-setting, actors seek to exert power through influence and control over material, human, intellectual and financial resources. Priority-setting arises as a consequence of the needs and demand exceeding the resources available, requiring some means of choosing between competing demands. This paper examines the use of power within priority-setting processes for healthcare resources at sub-national level, following devolution in Kenya. Methods We interviewed 14 national level key informants and 255 purposively selected respondents from across the health system in ten counties. These qualitative data were supplemented by 14 focus group discussions (FGD) involving 146 community members in two counties. We conducted a power analysis using Gaventa’s power cube and Veneklasen’s expressions of power to interpret our findings. Results We found Kenya’s transition towards devolution is transforming the former centralised balance of power, leading to greater ability for influence at the county level, reduced power at national and sub-county (district) levels, and limited change at community level. Within these changing power structures, politicians are felt to play a greater role in priority-setting for health. The interfaces and tensions between politicians, health service providers and the community has at times been felt to undermine health related technical priorities. Underlying social structures and discriminatory practices generally continue unchanged, leading to the continued exclusion of the most vulnerable from priority-setting processes. Conclusions Power analysis of priority-setting at county level after devolution in Kenya highlights the need for stronger institutional structures, processes and norms to reduce the power imbalances between decision-making actors and to enable community participation.