How are health systems in sub-Saharan Africa adapting to protect human health from climate change threats? A scoping review and case study.

BACKGROUND: Sub-Saharan Africa stands out as one of the regions most affected by the climate crisis, while it has contributed to the problem only marginally. The foreseen negative effect on health adds great stress to the already overburdened health systems. Health systems' adaptation to climate change is, therefore, urgently needed to better protect human health. There is, however, scant evidence on how adaption is being planned and implemented in Africa. The aim of this study was to review the literature on health system adaptation in sub-Saharan Africa. METHODS: In this scoping review and case study, we first carried out the scoping review, searching for publications on adaptation measures using the PubMed, Science Direct, and Web of Science databases on July 1, 2023. We included papers in English and French that addressed the adaptation of health systems in countries in sub-Saharan Africa without time limit. Second, we did a case study of the design and implementation of the National Adaptation Plan of Benin, with a specific focus on the policy-making process underlying the plan, whereby we used the health policy triangle as a policy analysis framework. Data were collected through a document review of national policy plans, reports, and evaluations. FINDINGS: A total of 14 papers met the inclusion criteria, showing that climate change adaptation remains a niche in the literature for sub-Saharan Africa. Most included papers were authored by individuals from high-income countries. Health system adaptation measures cover seven domains: health systems strengthening; policy and planning; financing and implementation; information and capacity building; societal resilience; disaster risk prevention, preparedness, response, and recovery; and mitigation. The review found that the dominant role of global agencies in supporting or steering health system adaptation planning contributes to policy mimicry across countries, as confirmed by the case study of the adaptation plan in Benin. Benin's National Adaptation Plan prioritised three climate hazards: heat, drought, and flooding. Although the financial and technical inputs of international agencies effectively support Benin's adaptation planning, these inputs might induce a more narrow focus that does not fully respond to Benin's needs in terms of climate shocks and adaptation priorities. INTERPRETATION: Health systems in sub-Saharan Africa are already adapting to climate change. Future research could focus on how national governments could develop adaptation plans that are responsive to local needs by making the needs analysis and priority-setting processes more inclusive of local stakeholders. FUNDING: The Belgian Directorate-General for Development Cooperation and Humanitarian Aid.

How capacity building of district health managers has been designed, delivered and evaluated in sub-Saharan Africa: a scoping review and best fit framework analysis.

OBJECTIVES: We aimed to understand how capacity building programmes (CBPs) of district health managers (DHMs) have been designed, delivered and evaluated in sub-Saharan Africa. We focused on identifying the underlying assumptions behind leadership and management CBPs at the district level. DESIGN: Scoping review. DATA SOURCES: We searched five electronic databases (MEDLINE, Health Systems Evidence, Wiley Online Library, Cochrane Library and Google Scholar) on 6 April 2021 and 13 October 2022. We also searched for grey literature and used citation tracking. ELIGIBILITY CRITERIA: We included all primary studies (1) reporting leadership or management capacity building of DHMs, (2) in sub-Saharan Africa, (3) written in English or French and (4) published between 1 January 1987 and 13 October 2022. DATA EXTRACTION AND SYNTHESIS: Three independent reviewers extracted data from included articles. We used the best fit framework synthesis approach to identify an a priori framework that guided data coding, analysis and synthesis. We also conducted an inductive analysis of data that could not be coded against the a priori framework. RESULTS: We identified 2523 papers and ultimately included 44 papers after screening and assessment for eligibility. Key findings included (1) a scarcity of explicit theories underlying CBPs, (2) a diversity of learning approaches with increasing use of the action learning approach, (3) a diversity of content with a focus on management rather than leadership functions and (4) a diversity of evaluation methods with limited use of theory-driven designs to evaluate leadership and management capacity building interventions. CONCLUSION: This review highlights the need for explicit and well-articulated programme theories for leadership and management development interventions and the need for strengthening their evaluation using theory-driven designs that fit the complexity of health systems.

Capacity building of district health management teams in the era of provincial health administration reform in the Democratic Republic of Congo: a realist evaluation protocol.

INTRODUCTION: In 2006, the Congolese Ministry of Health developed a health system strengthening strategy focusing on health district development. This strategy called for reforming the provincial health administration in order to better support the health district development through leadership and management capacity building of district health management teams. The implementation is currently underway, yet, more evidence on how, for whom and under what conditions this capacity building works is needed. The proposed research aims to address this gap using a realist evaluation approach. METHODS AND ANALYSIS: We will follow the cycle of the realist evaluation. First, we will elicit the initial programme theory through a scoping review (completed in December 2022, using MEDLINE, Health Systems Evidence, Wiley Online Library, Cochrane Library, Google Scholar and grey literature), a review of health policy documents (completed in March 2023), and interviews with key stakeholders (by June 2023). Second, we will empirically test the initial programme theory using a multiple-embedded case study design in two provincial health administrations and four health districts (by March 2024). Data will be collected through document reviews, in-depth interviews, non-participant observations, a questionnaire, routine data from the health information management system and a context mapping tool. We will analyse data using the Intervention-Context-Actor-Mechanism-Outcome configuration heuristic. Last, we will refine the initial programme theory based on the results of the empirical studies and develop recommendations for policymakers (by June 2024). ETHICS AND DISSEMINATION: The Institutional Review Board of the Institute of Tropical Medicine and the Medical Ethics Committee of the University of Lubumbashi approved this study. We will also seek approvals from provincial-level and district-level health authorities before data collection in their jurisdictions. We will disseminate the study findings through the publication of articles in peer-reviewed academic journals, policy briefs for national policymakers and presentations at national and international conferences.

Methodological reflections on health system-oriented assessment of maternity care in 16 hospitals in sub-Saharan Africa: an embedded case study.

Health facility assessments (HFAs) assessing facilities' readiness to provide services are well-established. However, HFA questionnaires are typically quantitative and lack depth to understand systems in which health facilities operate-crucial to designing context-oriented interventions. We report lessons from a multiple embedded case study exploring the experiences of HFA data collectors in implementing a novel HFA tool developed using systems thinking approach. We assessed 16 hospitals in four countries (Benin, Malawi, Tanzania and Uganda) as part of a quality improvement implementation research. Our tool was organized in 17 sections and included dimensions of hospital governance, leadership and financing; maternity care standards and procedures; ongoing quality improvement practices; interactions with communities and mapping of the areas related to maternal care. Data for this study were collected using in-depth interviews with senior experts who conducted the HFA in the countries 1-3 months after completion of the HFAs. Data were analysed using the inductive thematic analysis approach. Our HFA faced challenges in logistics (accessing key hospital-based respondents, high turnover of managerial staff and difficulty accessing information considered sensitive in the context) and methodology (response bias, lack of data quality and data entry into an electronic platform). Data elements of governance, leadership and financing were the most affected. Opportunities and strategies adopted aimed at enhancing data collection (building on prior partnerships and understanding local and institutional bureaucracies) and enhancing data richness (identifying respondents with institutional memory, learning from experience and conducting observations at various times). Moreover, HFA data collectors conducted abstraction of records and interviews in a flexible and adaptive way to enhance data quality. Lessons and new skills learned from our HFA could be used as inputs to respond to the growing need of integrating the systems thinking approach in HFA to improve the contextual understanding of operations and structure.

Realist evaluation in times of decolonising global health.

Realist evaluation (RE) is a theory-driven evaluation approach inspired by scientific realism. It has become increasingly popular in the field of global health where it is often applied in low- and middle-income countries. This makes it timely to discuss RE's relationship to the emerging decolonisation of global health movement. In this short perspective, we argue that the principles and practices that underpin RE have great potential to contribute to the decolonisation endeavour. Both the focus on the inclusion of local stakeholders and the openness to the rival theories these stakeholders bring to the fore, are promising. However, in practice, we see that a lack of acknowledgement of power imbalances and different ontologies and an overreliance on Western-based theories thwart this potential. We therefore suggest that realist evaluations performed by external researchers, especially in the field of global health, should actively engage with issues of (power) inequities. This is not only the just thing to do, but will also contribute to a better understanding of the intervention and may facilitate the emancipation of the disenfranchised. One way of doing this is through the adoption of participatory (action) research methods, currently underused in realist evaluations. We finally give a short example of an evaluation that combines emancipatory and participatory practice development with a realist approach. The Afya-Tek project in Tanzania has an innovative bottom-up approach throughout the full evaluation cycle and shows the possible strength of the proposed combination to create better interventions, more empowered stakeholders, and more illuminating programme theories.

Strengthening capacity in hospitals to reduce perinatal morbidity and mortality through a codesigned intervention package: protocol for a realist evaluation as part of a stepped-wedge trial of the Action Leveraging Evidence to Reduce perinatal morTality and morbidity (ALERT) in sub-Saharan Africa project.

INTRODUCTION: Despite a strong evidence base for developing interventions to reduce child mortality and morbidity related to pregnancy and delivery, major knowledge-implementation gaps remain. The Action Leveraging Evidence to Reduce perinatal morTality and morbidity (ALERT) in sub-Saharan Africa project aims to overcome these gaps through strengthening the capacity of multidisciplinary teams that provide maternity care. The intervention includes competency-based midwife training, community engagement for study design, mentoring and quality improvement cycles. The realist process evaluation of ALERT aims at identifying and testing the causal pathway through which the intervention achieves its impact. METHODS AND ANALYSIS: This realist process evaluation complements the effectiveness evaluation and the economic evaluation of the ALERT intervention. Following the realist evaluation cycle, we will first elicit the initial programme theory on the basis of the ALERT theory of change, a review of the evidence on adoption and diffusion of innovations and the perspectives of the stakeholders. Second, we will use a multiple embedded case study design to empirically test the initial programme theory in two hospitals in each of the four intervention countries. Qualitative and quantitative data will be collected, using in-depth interviews with hospital staff and mothers, observations, patient exit interviews and (hospital) document reviews. Analysis will be guided by the Intervention-Actors-Context-Mechanism-Outcome configuration heuristic. We will use thematic coding to analyse the qualitative data. The quantitative data will be analysed descriptively and integrated in the analysis using a retroductive approach. Each case study will end with a refined programme theory (in-case analysis). Third, we will carry out a cross-case comparison within and between the four countries. Comparison between study countries should enable identifying relevant context factors that influence effectiveness and implementation, leading to a mid-range theory that may inform the scaling up the intervention. ETHICS AND DISSEMINATION: In developing this protocol, we paid specific attention to cultural sensitivity, the do no harm principle, confidentiality and non-attribution. We received ethical approval from the local and national institutional review boards in Tanzania, Uganda, Malawi, Benin, Sweden and Belgium. Written or verbal consent of respondents will be secured after explaining the purpose, potential benefits and potential harms of the study using an information sheet. The results will be disseminated through workshops with the hospital staff and national policymakers, and scientific publications and conferences. TRIAL REGISTRATION NUMBER: PACTR202006793783148.

Action leveraging evidence to reduce perinatal mortality and morbidity (ALERT): study protocol for a stepped-wedge cluster-randomised trial in Benin, Malawi, Tanzania and Uganda.

BACKGROUND: Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period. METHODS: This is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial's primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention. DISCUSSION: There is evidence that each of the ALERT intervention components improves health providers' practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions. TRIAL REGISTRATION: Pan African Clinical Trial Registry ( www.pactr.org ): PACTR202006793783148. Registered on 17th June 2020.

Decoding the black box of health policy implementation: A case of regulating private healthcare establishments in southern India.

Background: . Implementation of healthcare regulatory policies, especially in low- and middle-income countries where the private health sector is predominant, is challenging. Karnataka, a southern state in India, enacted the Karnataka Private Medical Establishments Act (KPMEA) with an aim to ensure quality of care in the private healthcare establishments. After more than a decade the implementation of KPMEA is suboptimal. Methods: . We used a case study design. The case was 'implementation of KPMEA'. The case study site was Bengaluru Urban district in Karnataka. Data from key informant interviews, focus group discussions held at the state, district and subdistrict levels and key policy documents, minutes of the meetings, data from the State Department of Health and Family Welfare, district level KPMEA data and litigations at the High Court of Karnataka were analysed using a framework. Results: . The policy (KPMEA) content is inadequate and requires clarity in certain provisions of the Act. There was a lack of coordination between the implementing agencies. Workforce shortages were evident. Factors that impede the enforcement of the Act include poor knowledge and lack of competency of the officials on the content and the implementation mechanics of the policy, insufficient policy oversight from the state on the districts, corruption, political interference and lack of support from the local public, especially during raids on illegal establishments. Conclusions: . A regulatory policy such as KPMEA needs a clear, comprehensive content and directions for operationalization. However, improving the content of the policy is not easy as some aspects of the policy remain contentious with the private healthcare providers/ establishments. Addressing health governance issues at all levels is key to effective enforcement.

How do participatory methods shape policy? Applying a realist approach to the formulation of a new tuberculosis policy in Georgia.

OBJECTIVES: This paper presents the iterative process of participatory multistakeholder engagement that informed the development of a new national tuberculosis (TB) policy in Georgia, and the lessons learnt. METHODS: Guided by realist evaluation methods, a multistakeholder dialogue was organised to elicit stakeholders' assumptions on challenges and possible solutions for better TB control. Two participatory workshops were conducted with key actors, interspersed by reflection meetings within the research team and discussions with policymakers. Using concept mapping and causal mapping techniques, and drawing causal loop diagrams, we visualised how actors understood TB service provision challenges and the potential means by which a results-based financing (RBF) policy could address these. SETTING: The study was conducted in Tbilisi, Georgia. PARTICIPANTS: A total of 64 key actors from the Ministry of Labour, Health and Social Affairs, staff of the Global Fund to Fight AIDS, TB and Malaria Georgia Project, the National Centre for Disease Control and Public Health, the National TB programme, TB service providers and members of the research team were involved in the workshops. RESULTS: Findings showed that beyond provider incentives, additional policy components were necessary. These included broadening the incentive package to include institutional and organisational incentives, retraining service providers, clear redistribution of roles to support an integrated care model, and refinement of monitoring tools. Health system elements, such as effective referral systems and health information systems were highlighted as necessary for service improvement. CONCLUSIONS: Developing policies that address complex issues requires methods that facilitate linkages between multiple stakeholders and between theory and practice. Such participatory approaches can be informed by realist evaluation principles and visually facilitated by causal loop diagrams. This approach allowed us leverage stakeholders' knowledge and expertise on TB service delivery and RBF to codesign a new policy.

Opening the 'implementation black-box' of the user fee exemption policy for caesarean section in Benin: a realist evaluation.

To improve access to maternal health services, Benin introduced in 2009 a user fee exemption policy for caesarean sections. Similar to other low- and middle-income countries, its implementation showed mixed results. Our study aimed at understanding why and in which circumstances the implementation of this policy in hospitals succeeded or failed. We adopted the realist evaluation approach and tested the initial programme theory through a multiple embedded case study design. We selected two hospitals with contrastive outcomes. We used data from 52 semi-structured interviews, a patient exit survey, a costing study of caesarean section and an analysis of financial flows. In the analysis, we used the intervention-context-actor-mechanism-outcome configuration heuristic. We identified two main causal pathways. First, in the state-owned hospital, which has a public-oriented but administrative management system, and where citizens demand accountability through various channels, the implementation process was effective. In the non-state-owned hospital, managers were guided by organizational financial interests more than by the inherent social value of the policy, there was a perceived lack of enforcement and the implementation was poor. We found that trust, perceived coercion, adherence to policy goals, perceived financial incentives and fairness in their allocation drive compliance, persuasion, positive responses to incentives and self-efficacy at the operational level to generate the policy implementation outcomes. Compliance with the policy depended on enforcement by hierarchical authority and bottom-up pressure. Persuasion depended on the alignment of the policy with personal and organizational values. Incentives may determine the adoption if they influence the local stakeholder's revenue are trustworthy and perceived as fairly allocated. Failure to anticipate the differential responses of implementers will prevent the proper implementation of user fee exemption policies and similar universal health coverage reforms.

A systems perspective on the importance of global health strategy developments for accomplishing today's Sustainable Development Goals.

Priority setting within health systems has not led to accountable, fair and sustainable solutions to improving population health. Providers, users and other stakeholders each have their own health and service priorities based on selected evidence, own values, expertise and preferences. Based on a historical account, this article analyses if contemporary health systems are appropriate to optimize population health within the framework of cross cutting targets of the Sustainable Development Goals (SDGs). We applied a scoping review approach to identify and review literature of scientific databases and other programmatic web and library-based documents on historical and contemporary health systems policies and strategies at the global level. Early literature supported the 1977 launching of the global target of Health for All by the year 2000. Reviewed literature was used to provide a historical overview of systems components of global health strategies through describing the conceptualizations of health determinants, user involvement and mechanisms of priority setting over time, and analysing the importance of historical developments on barriers and opportunities to accomplish the SDGs. Definitions, scope and application of health systems-associated priority setting fluctuated and main health determinants and user influence on global health systems and priority setting remained limited. In exploring reasons for the identified lack of SDG-associated health systems and priority setting processes, we discuss issues of accountability, vested interests, ethics and democratic legitimacy as conditional for future sustainability of population health. To accomplish the SDGs health systems must engage beyond their own sector boundary. New approaches to Health in All Policies and One Health may be conducive for scaling up more democratic and inclusive priority setting processes based on proper process guidelines from successful pilots. Sustainable development depends on population preferences supported by technical and managerial expertise.

Designing and evaluating provider results-based financing for tuberculosis care in Georgia: a realist evaluation protocol.

INTRODUCTION: In 2016, Georgian researchers and policymakers were developing a policy to improve the performance of the national tuberculosis (TB) control programme. The research programme 'Designing and Evaluating Provider Results-Based Financing for Tuberculosis Care in Georgia: Understanding Costs, Mechanisms of Effect and Impact (Results4TB)' was initiated to inform the policy formulation phase, document the policy implementation and assess the effectiveness, cost-effectiveness and the processes of change. To achieve this, the research team intends to combine an impact evaluation, a cost-effectiveness study and a realist evaluation (RE) within an overarching theory-informed design. This protocol is the RE component of the programme. METHODS: A realist methodological approach will be adopted to guide the research design and evaluation. RE answers the question of 'what works in which conditions for whom?' and starts with the development of an initial programme theory (IPT). The IPT will feed into other phases of the realist research cycle (study design, data collection, data analysis and synthesis and theory refinement). Data will be collected in a multiple embedded case study design (five intervention and three control sites) through document reviews, in-depth interviews, non-participant observations and context mapping at facility and national levels. Additional data from other research components (cost-effectiveness and impact evaluation) will aid data triangulation. ETHICS AND DISSEMINATION: The Institutional Review Boards of the National Centre for Disease Control and Public Health in Georgia (ref. IRB # 2018-019) and the Institute of Tropical Medicine, Antwerp (ref. IRB #- 1240/18) have granted ethical approval to the study. TRIAL REGISTRATION NUMBER: ISRCTN14667607.

Towards Health Equity and Transformative Action on tribal health (THETA) study to describe, explain and act on tribal health inequities in India: A health systems research study protocol.

Background: In India, heterogenous tribal populations are grouped together under a common category, Scheduled Tribe, for affirmative action. Many tribal communities are closely associated with forests and difficult-to-reach areas and have worse-off health and nutrition indicators. However, poor population health outcomes cannot be explained by geography alone. Social determinants of health, especially various social disadvantages, compound the problem of access and utilisation of health services and undermine their health and nutritional status. The Towards Health Equity and Transformative Action on tribal health (THETA) study has three objectives: (1) describe and analyse extent and patterns of health inequalities, (2) generate theoretical explanations, and (3) pilot an intervention to validate the explanation.     Methods: For objective 1, we will conduct household surveys in seven forest areas covering 2722 households in five states across India, along a gradient of socio-geographic disadvantage. For objective 2, we will purposefully select case studies illustrating processes through which socio-geographic disadvantages act at the individual, household/neighbourhood, village or population level, paying careful attention to the interactions across various known axes of inequity. We will use a realist evaluation approach with context-mechanism-outcome configurations generated from the wider literature on tribal health and results of objective 1. For objective 3, we will partner with willing stakeholders to design and pilot an equity-enhancing intervention, drawing on the theoretical explanation generated and evaluate it to further refine our final explanatory theory. Discussion: THETA project seeks to generate site-specific evidence to guide public health policy and programs to better contribute to equitable health in tribal populations. It fulfills the current gap in generating and testing explanatory social theories on the persistent and unfair accumulation of geographical and social disadvantage among tribal populations and finally examines if such approaches could help design equity-enhancing interventions to improve tribal health.

Unearthing how, why, for whom and under what health system conditions the antiretroviral treatment adherence club intervention in South Africa works: A realist theory refining approach.

BACKGROUND: Poor retention in care and suboptimal adherence to antiretroviral treatment (ART) undermine its successful rollout in South Africa. The adherence club intervention was designed as an adherence-enhancing intervention to enhance the retention in care of patients on ART and their adherence to medication. Although empirical evidence suggests the effective superiority of the adherence club intervention to standard clinic ART care schemes, it is poorly understood exactly how and why it works, and under what health system contexts. To this end, we aimed to develop a refined programme theory explicating how, why, for whom and under what health system contexts the adherence club intervention works (or not). METHODS: We undertook a realist evaluation study to uncover the programme theory of the adherence club intervention. We elicited an initial programme theory of the adherence club intervention and tested the initial programme theory in three contrastive sites. Using a cross-case analysis approach, we delineated the conceptualisation of the intervention, context, actor and mechanism components of the three contrastive cases to explain the outcomes of the adherence club intervention, guided by retroductive inferencing. RESULTS: We found that an intervention that groups clinically stable patients on ART in a convenient space to receive a quick and uninterrupted supply of medication, health talks, counselling, and immediate access to a clinician when required works because patients' self-efficacy improves and they become motivated and nudged to remain in care and adhere to medication. The successful implementation and rollout of the adherence club intervention are contingent on the separation of the adherence club programme from other patients who are HIV-negative. In addition, there should be available convenient space for the adherence club meetings, continuous support of the adherence club facilitators by clinicians and buy-in from the health workers at the health-care facility and the community. CONCLUSION: Understanding what aspects of antiretroviral club intervention works, for what sections of the patient population, and under which community and health systems contexts, could inform guidelines for effective implementation in different contexts and scaling up of the intervention to improve population-level ART adherence.

A critique of the Uganda district league table using a normative health system performance assessment framework.

BACKGROUND: In 2003 the Uganda Ministry of Health (MoH) introduced the District League Table (DLT) to track district performance. This review of the DLT is intended to add to the evidence base on Health Systems Performance Assessment (HSPA) globally, with emphasis on Low and Middle Income Countries (LMICs), and provide recommendations for adjustments to the current Ugandan reality. METHODS: A normative HSPA framework was used to inform the development of a Key Informant Interview (KII) tool. Thirty Key Informants were interviewed, purposively selected from the Ugandan health system on the basis of having developed or used the DLT. KII data and information from published and grey literature on the Uganda health system was analyzed using deductive analysis. RESULTS: Stakeholder involvement in the development of the DLT was limited, including MoH officials and development partners, and a few district technical managers. Uganda policy documents articulate a conceptually broad health system whereas the DLT focuses on a healthcare system. The complexity and dynamism of the Uganda health system was insufficiently acknowledged by the HSPA framework. Though DLT objectives and indicators were articulated, there was no conceptual reference model and lack of clarity on the constitutive dimensions. The DLT mechanisms for change were not explicit. The DLT compared markedly different districts and did not identify factors behind observed performance. Uganda lacks a designated institutional unit for the analysis and presentation of HSPA data, and there are challenges in data quality and range. CONCLUSIONS: The critique of the DLT using a normative model supported the development of recommendation for Uganda district HSPA and provides lessons for other LMICs. A similar approach can be used by researchers and policy makers elsewhere for the review and development of other frameworks. Adjustments in Uganda district HSPA should consider: wider stakeholder involvement with more district managers including political, administrative and technical; better anchoring within the national health system framework; integration of the notion of complexity in the design of the framework; and emphasis on facilitating district decision-making and learning. There is need to improve data quality and range and additional approaches for data analysis and presentation.

Performance-based financing in low-income and middle-income countries: isn't it time for a rethink?

This paper questions the view that performance-based financing (PBF) in the health sector is an effective, efficient and equitable approach to improving the performance of health systems in low-income and middle-income countries (LMICs). PBF was conceived as an open approach adapted to specific country needs, having the potential to foster system-wide reforms. However, as with many strategies and tools, there is a gap between what was planned and what is actually implemented. This paper argues that PBF as it is currently implemented in many contexts does not satisfy the promises. First, since the start of PBF implementation in LMICs, concerns have been raised on the basis of empirical evidence from different settings and disciplines that indicated the risks, cost and perverse effects. However, PBF implementation was rushed despite insufficient evidence of its effectiveness. Second, there is a lack of domestic ownership of PBF. Considering the amounts of time and money it now absorbs, and the lack of evidence of effectiveness and efficiency, PBF can be characterised as a donor fad. Third, by presenting itself as a comprehensive approach that makes it possible to address all aspects of the health system in any context, PBF monopolises attention and focuses policy dialogue on the short-term results of PBF programmes while diverting attention and resources from broader processes of change and necessary reforms. Too little care is given to system-wide and long-term effects, so that PBF can actually damage health services and systems. This paper ends by proposing entry points for alternative approaches.

The challenge of complexity in evaluating health policies and programs: the case of women's participatory groups to improve antenatal outcomes.

BACKGROUND: During the last years, randomized designs have been promoted as the cornerstone of evidence-based policymaking. Also in the field of community participation, Random Control Trials (RCTs) have been the dominant design, used for instance to examine the contribution of community participation to health improvement. We aim at clarifying why RCTs and related (quasi-) experimental designs may not be the most appropriate approach to evaluate such complex programmes. RESULTS: We argue that the current methodological debate could be more fruitful if it would start from the position that the choice of designs should fit the nature of the program and research questions rather than be driven by methodological preferences. We present how realist evaluation, a theory-driven approach to research and evaluation, is a relevant methodology that could be used to assess whether and how community participation works. Using the realist evaluation approach to examine the relationship between participation and action of women groups and antenatal outcomes would enable evaluators to examine in detail the underlying mechanisms which influence actual practices and outcomes, as well as the context conditions required to make it work. CONCLUSIONS: Realist research in fact allows opening the black boxes of "community" and "participation" in order to examine the role they play in ensuring cost-effective, sustainable interventions. This approach yields important information for policy makers and programme managers considering how such programs could be implemented in their own setting.

The Need for Global Application of the Accountability for Reasonableness Approach to Support Sustainable Outcomes Comment on "Expanded HTA: Enhancing Fairness and Legitimacy".

The accountability for reasonableness (AFR) concept has been developed and discussed for over two decades. Its interpretation has been studied in several ways partly guided by the specific settings and the researchers involved. This has again influenced the development of the concept, but not led to universal application. The potential use in health technology assessments (HTAs) has recently been identified by Daniels et al as yet another excellent justification for AFR-based process guidance that refers to both qualitative and a broader participatory input for HTA, but it has raised concerns from those who primarily support the consistency and objectivity of more quantitative and reproducible evidence. With reference to studies of AFR-based interventions and the through these repeatedly documented motivation for their consolidation, we argue that it can even be unethical not to take AFR conditions beyond their still mainly formative stage and test their application within routine health systems management for their expected support to more sustainable health improvements. The ever increasing evidence and technical expertise are necessary but at times contradictory and do not in isolation lead to optimally accountable, fair and sustainable solutions. Technical experts, politicians, managers, service providers, community members, and beneficiaries each have their own values, expertise and preferences, to be considered for necessary buy in and sustainability. Legitimacy, accountability and fairness do not come about without an inclusive and agreed process guidance that can reconcile differences of opinion and indeed differences in evidence to arrive at a by all understood, accepted, but not necessarily agreed compromise in a current context - until major premises for the decision change. AFR should be widely adopted in projects and services under close monitoring and frequent reviews.

Building a middle-range theory of free public healthcare seeking in sub-Saharan Africa: a realist review.

Realist reviews are a new form of knowledge synthesis aimed at providing middle-range theories (MRTs) that specify how interventions work, for which populations, and under what circumstances. This approach opens the 'black box' of an intervention by showing how it triggers mechanisms in specific contexts to produce outcomes. We conducted a realist review of health user fee exemption policies (UFEPs) in sub-Saharan Africa (SSA). This article presents how we developed both the intervention theory (IT) of UFEPs and a MRT of free public healthcare seeking in SSA, building on Sen's capability approach. Over the course of this iterative process, we explored theoretical writings on healthcare access, services use, and healthcare seeking behaviour. We also analysed empirical studies on UFEPs and healthcare access in free care contexts. According to the IT, free care at the point of delivery is a resource allowing users to make choices about their use of public healthcare services, choices previously not generally available to them. Users' ability to choose to seek free care is influenced by structural, local, and individual conversion factors. We tested this IT on 69 empirical studies selected on the basis of their scientific rigor and relevance to the theory. From that analysis, we formulated a MRT on seeking free public healthcare in SSA. It highlights three key mechanisms in users' choice to seek free public healthcare: trust, risk awareness and acceptability. Contextual elements that influence both users' ability and choice to seek free care include: availability of and control over resources at the individual level; characteristics of users' and providers' communities at the local level; and health system organization, governance and policies at the structural level.