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OBJECTIVE: To assess whether adding a training intervention for clinic staff to the usual DOTS strategy (the internationally recommended control strategy for tuberculosis (TB)) would affect the outcomes of TB treatment in primary care clinics with treatment success rates below 70%. METHODS: A cluster randomized controlled trial was conducted from July 1996 to July 2000 in nurse-managed ambulatory primary care clinics in Cape Town, South Africa. Clinics with successful TB treatment completion rates of less than 70% and annual adult pulmonary TB loads of more than 40 patients per year were randomly assigned to either the intervention (n = 12) or control (n = 12) groups. All clinics completed follow-up. Treatment outcomes were measured in cohorts of adult, pulmonary TB patients before the intervention (n = 1200) and 9 months following the training (n = 1177). The intervention comprised an 18-hour experiential, participatory in-service training programme for clinic staff delivered by nurse facilitators and focusing on patient centredness, critical reflection on practice, and quality improvement. The main outcome measure was successful treatment, defined as patients who were cured and those who had completed tuberculosis treatment. FINDINGS: The estimated effect of the intervention was an increase in successful treatment rates of 4.8% (95% confidence interval (CI): -5.5% to 15.2%) and in bacteriological cure rates of 10.4% (CI: -1.2% to 22%). A treatment effect of 10% was envisaged, based on the views of policy-makers on the minimum effect size for large-scale implementation. CONCLUSION: This is the first evidence from a randomized controlled trial on the effects of experiential, participatory training on TB outcomes in primary care facilities in a developing country. Such training did not appear to improve TB outcomes. However, the results were inconclusive and further studies are required.

Abstract This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. The term monitoring is commonly used to describe the process of systematically collecting data to inform policymakers, managers and other stakeholders whether a new policy or programme is being implemented in accordance with their expectations. Indicators are used for monitoring purposes to judge, for example, if objectives are being achieved, or if allocated funds are being spent appropriately. Sometimes the term evaluation is used interchangeably with the term monitoring, but the former usually suggests a stronger focus on the achievement of results. When the term impact evaluation is used, this usually implies that there is a specific attempt to try to determine whether the observed changes in outcomes can be attributed to a particular policy or programme. In this article, we suggest four questions that can be used to guide the monitoring and evaluation of policy or programme options. These are: 1. Is monitoring necessary? 2. What should be measured? 3. Should an impact evaluation be conducted? 4. How should the impact evaluation be done?

Abstract This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. Policy dialogues allow research evidence to be considered together with the views, experiences and tacit knowledge of those who will be involved in, or affected by, future decisions about a high-priority issue. Increasing interest in the use of policy dialogues has been fuelled by a number of factors: 1. The recognition of the need for locally contextualised 'decision support' for policymakers and other stakeholders 2. The recognition that research evidence is only one input into the decision-making processes of policymakers and other stakeholders 3. The recognition that many stakeholders can add significant value to these processes, and 4. The recognition that many stakeholders can take action to address high-priority issues, and not just policymakers. In this article, we suggest questions to guide those organising and using policy dialogues to support evidence-informed policymaking. These are: 1. Does the dialogue address a high-priority issue? 2. Does the dialogue provide opportunities to discuss the problem, options to address the problem, and key implementation considerations? 3. Is the dialogue informed by a pre-circulated policy brief and by a discussion about the full range of factors that can influence the policymaking process? 4. Does the dialogue ensure fair representation among those who will be involved in, or affected by, future decisions related to the issue? 5. Does the dialogue engage a facilitator, follow a rule about not attributing comments to individuals, and not aim for consensus? 6. Are outputs produced and follow-up activities undertaken to support action?

Abstract This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. In this article, we address strategies to inform and engage the public in policy development and implementation. The importance of engaging the public (both patients and citizens) at all levels of health systems is widely recognised. They are the ultimate recipients of the desirable and undesirable impacts of public policies, and many governments and organisations have acknowledged the value of engaging them in evidence-informed policy development. The potential benefits of doing this include the establishment of policies that include their ideas and address their concerns, the improved implementation of policies, improved health services, and better health. Public engagement can also be viewed as a goal in itself by encouraging participative democracy, public accountability and transparency. We suggest three questions that can be considered with regard to public participation strategies. These are: 1. What strategies can be used when working with the mass media to inform the public about policy development and implementation? 2. What strategies can be used when working with civil society groups to inform and engage them in policy development and implementation? 3. What methods can be used to involve consumers in policy development and implementation?

Abstract This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. Policymakers and those supporting them often find themselves in situations that spur them on to work out how best to define a problem. These situations may range from being asked an awkward or challenging question in the legislature, through to finding a problem highlighted on the front page of a newspaper. The motivations for policymakers wanting to clarify a problem are diverse. These may range from deciding whether to pay serious attention to a particular problem that others claim is important, through to wondering how to convince others to agree that a problem is important. Debates and struggles over how to define a problem are a critically important part of the policymaking process. The outcome of these debates and struggles will influence whether and, in part, how policymakers take action to address a problem. Efforts at problem clarification that are informed by an appreciation of concurrent developments are more likely to generate actions. These concurrent developments can relate to policy and programme options (e.g. the publication of a report demonstrating the effectiveness of a particular option) or to political events (e.g. the appointment of a new Minister of Health with a personal interest in a particular issue). In this article, we suggest questions that can be used to guide those involved in identifying a problem and characterising its features. These are: 1. What is the problem? 2. How did the problem come to attention and has this process influenced the prospect of it being addressed? 3. What indicators can be used, or collected, to establish the magnitude of the problem and to measure progress in addressing it? 4. What comparisons can be made to establish the magnitude of the problem and to measure progress in addressing it? 5. How can the problem be framed (or described) in a way that will motivate different groups?

Abstract This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. Policymakers and those supporting them may find themselves in one or more of the following three situations that will require them to characterise the costs and consequences of options to address a problem. These are: 1. A decision has already been taken and their role is to maximise the benefits of an option, minimise its harms, optimise the impacts achieved for the money spent, and (if there is substantial uncertainty about the likely costs and consequences of the option) to design a monitoring and evaluation plan, 2. A policymaking process is already underway and their role is to assess the options presented to them, or 3. A policymaking process has not yet begun and their role is therefore to identify options, characterise the costs and consequences of these options, and look for windows of opportunity in which to act. In situations like these, research evidence, particularly about benefits, harms, and costs, can help to inform whether an option can be considered viable. In this article, we suggest six questions that can be used to guide those involved in identifying policy and programme options to address a high-priority problem, and to characterise the costs and consequences of these options. These are: 1. Has an appropriate set of options been identified to address a problem? 2. What benefits are important to those who will be affected and which benefits are likely to be achieved with each option? 3. What harms are important to those who will be affected and which harms are likely to arise with each option? 4. What are the local costs of each option and is there local evidence about their cost-effectiveness? 5. What adaptations might be made to any given option and could they alter its benefits, harms and costs? 6. Which stakeholder views and experiences might influence an option's acceptability and its benefits, harms, and costs?

Abstract This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. In this article, we address considerations about resource use and costs. The consequences of a policy or programme option for resource use differ from other impacts (both in terms of benefits and harms) in several ways. However, considerations of the consequences of options for resource use are similar to considerations related to other impacts in that policymakers and their staff need to identify important impacts on resource use, acquire and appraise the best available evidence regarding those impacts, and ensure that appropriate monetary values have been applied. We suggest four questions that can be considered when assessing resource use and the cost consequences of an option. These are: 1. What are the most important impacts on resource use? 2. What evidence is there for important impacts on resource use? 3. How confident is it possible to be in the evidence for impacts on resource use? 4. Have the impacts on resource use been valued appropriately in terms of their true costs?

Abstract This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. Differences between health systems may often result in a policy or programme option that is used in one setting not being feasible or acceptable in another. Or these differences may result in an option not working in the same way in another setting, or even achieving different impacts in another setting. A key challenge that policymakers and those supporting them must face is therefore the need to understand whether research evidence about an option can be applied to their setting. Systematic reviews make this task easier by summarising the evidence from studies conducted in a variety of different settings. Many systematic reviews, however, do not provide adequate descriptions of the features of the actual settings in which the original studies were conducted. In this article, we suggest questions to guide those assessing the applicability of the findings of a systematic review to a specific setting. These are: 1. Were the studies included in a systematic review conducted in the same setting or were the findings consistent across settings or time periods? 2. Are there important differences in on-the-ground realities and constraints that might substantially alter the feasibility and acceptability of an option? 3. Are there important differences in health system arrangements that may mean an option could not work in the same way? 4. Are there important differences in the baseline conditions that might yield different absolute effects even if the relative effectiveness was the same? 5. What insights can be drawn about options, implementation, and monitoring and evaluation? Even if there are reasonable grounds for concluding that the impacts of an option might differ in a specific setting, insights can almost always be drawn from a systematic review about possible options, as well as approaches to the implementation of options and to monitoring and evaluation.

Abstract This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. After a policy decision has been made, the next key challenge is transforming this stated policy position into practical actions. What strategies, for instance, are available to facilitate effective implementation, and what is known about the effectiveness of such strategies? We suggest five questions that can be considered by policymakers when implementing a health policy or programme. These are: 1. What are the potential barriers to the successful implementation of a new policy? 2. What strategies should be considered in planning the implementation of a new policy in order to facilitate the necessary behavioural changes among healthcare recipients and citizens? 3. What strategies should be considered in planning the implementation of a new policy in order to facilitate the necessary behavioural changes in healthcare professionals? 4. What strategies should be considered in planning the implementation of a new policy in order to facilitate the necessary organisational changes? 5. What strategies should be considered in planning the implementation of a new policy in order to facilitate the necessary systems changes?

Abstract This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. In this article, we address ways of organising efforts to support evidence-informed health policymaking. Efforts to link research to action may include a range of activities related to the production of research that is both highly relevant to – and appropriately synthesised for – policymakers. Such activities may include a mix of efforts used to link research to action, as well as the evaluation of such efforts. Little is known about how best to organise the range of activity options available and, until recently, there have been relatively few organisations responsible for supporting the use of research evidence in developing health policy. We suggest five questions that can help guide considerations of how to improve organisational arrangements to support the use of research evidence to inform health policy decision making. These are: 1. What is the capacity of your organisation to use research evidence to inform decision making? 2. What strategies should be used to ensure collaboration between policymakers, researchers and stakeholders? 3. What strategies should be used to ensure independence as well as the effective management of conflicts of interest? 4. What strategies should be used to ensure the use of systematic and transparent methods for accessing, appraising and using research evidence? 5. What strategies should be used to ensure adequate capacity to employ these methods?

Abstract This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. Systematic reviews are increasingly seen as a key source of information in policymaking, particularly in terms of assisting with descriptions of the impacts of options. Relative to single studies they offer a number of advantages related to understanding impacts and are also seen as a key source of information for clarifying problems and providing complementary perspectives on options. Systematic reviews can be undertaken to place problems in comparative perspective and to describe the likely harms of an option. They also assist with understanding the meanings that individuals or groups attach to a problem, how and why options work, and stakeholder views and experiences related to particular options. A number of constraints have hindered the wider use of systematic reviews in policymaking. These include a lack of awareness of their value and a mismatch between the terms employed by policymakers, when attempting to retrieve systematic reviews, and the terms used by the original authors of those reviews. Mismatches between the types of information that policymakers are seeking, and the way in which authors fail to highlight (or make obvious) such information within systematic reviews have also proved problematic. In this article, we suggest three questions that can be used to guide those searching for systematic reviews, particularly reviews about the impacts of options being considered. These are: 1. Is a systematic review really what is needed? 2. What databases and search strategies can be used to find relevant systematic reviews? 3. What alternatives are available when no relevant review can be found?

Abstract Background Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART) access. However, the evidence for nurse-initiated and managed ART (NIMART) in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) programme was a complex educational and organisational intervention implemented in the Free State Province of South Africa to enable nurses providing primary HIV/AIDS care to expand their roles and include aspects of care and treatment usually provided by physicians. STRETCH used a phased implementation approach and ART treatment guidelines tailored specifically to nurses. The effects of STRETCH on pre-ART mortality, ART provision, and the quality of HIV/ART care were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation of the programme. Methods This study was a qualitative process evaluation using in-depth interviews and focus group discussions with patients, health workers, health managers, and other key informants as well as observation in clinics. Research questions focused on perceptions of STRETCH, changes in health provider roles, attitudes and patient relationships, and impact of the implementation context on trial outcomes. Data were analysed collaboratively by the research team using thematic analysis. Results NIMART appears to be highly acceptable among nurses, patients, and physicians. Managers and nurses expressed confidence in their ability to deliver ART successfully. This confidence developed slowly and unevenly, through a phased and well-supported approach that guided nurses through training, re-prescription, and initiation. The research also shows that NIMART changes the working and referral relationships between health staff, demands significant training and support, and faces workload and capacity constraints, and logistical and infrastructural challenges. Conclusions Large-scale NIMART appears to be feasible and acceptable in the primary level public sector health services in South Africa. Successful implementation requires a comprehensive approach with: an incremental and well supported approach to implementation; clinical guidelines tailored to nurses; and significant health services reorganisation to accommodate the knock-on effects of shifts in practice. Trial registration ISRCTN46836853

Abstract Background Effective provider-parent communication can improve childhood vaccination uptake and strengthen immunisation services in low- and middle-income countries (LMICs). Building capacity to improve communication strategies has been neglected. Rigorous research exists but is not readily found or applicable to LMICs, making it difficult for policy makers to use it to inform vaccination policies and practice. The aim of this project is to build research knowledge and capacity to use evidence-based strategies for improving communication about childhood vaccinations with parents and communities in LMICs. Methods and design This project is a mixed methods study with six sub-studies. In sub-study one, we will develop a systematic map of provider-parent communication interventions for childhood vaccinations by screening and extracting data from relevant literature. This map will inform sub-study two, in which we will develop a taxonomy of interventions to improve provider-parent communication around childhood vaccination. In sub-study three, the taxonomy will be populated with trial citations to create an evidence map, which will also identify how evidence is linked to communication barriers regarding vaccination. In the project's fourth sub-study, we will present the interventions map, taxonomy, and evidence map to international stakeholders to identify high-priority topics for systematic reviews of interventions to improve parent-provider communication for childhood vaccination. We will produce systematic reviews of the effects of high-priority interventions in the fifth sub-study. In the sixth and final sub-study of the project, evidence from the systematic reviews will be translated into accessible formats and messages for dissemination to LMICs. Discussion This project combines evidence mapping, conceptual and taxonomy development, priority setting, systematic reviews, and knowledge transfer. It will build and share concepts, terms, evidence, and resources to aid the development of communication strategies for effective vaccination programmes in LMICs.

Abstract Background Over thirty years have passed since the Alma-Ata Declaration on primary health care in 1978. Many governments in the first decade following the declaration responded by developing national programmes of community health workers (CHWs), but evaluations of these often demonstrated poor outcomes. As many CHW programmes have responded to the HIV/AIDS pandemic, international interest in them has returned and their role in the response to other diseases should be examined carefully so that lessons can be applied to their new roles. Over half of the deaths in African children under five years of age are due to malaria, diarrhoea and pneumonia - a situation which could be addressed through the use of cheap and effective interventions delivered by CHWs. However, to date there is very little evidence from randomised controlled trials of the impacts of CHW programmes on child mortality in Africa. Evidence from non-randomised controlled studies has not previously been reviewed systematically. Methods We searched databases of published and unpublished studies for RCTs and non-randomised studies evaluating CHW programmes delivering curative treatments, with or without preventive components, for malaria, diarrhoea or pneumonia, in children in sub-Saharan Africa from 1987 to 2007. The impact of these programmes on morbidity or mortality in children under six years of age was reviewed. A descriptive analysis of interventional and contextual factors associated with these impacts was attempted. Results The review identified seven studies evaluating CHWs, delivering a range of interventions. Limited descriptive data on programmes, contexts or process outcomes for these CHW programmes were available. CHWs in national programmes achieved large mortality reductions of 63% and 36% respectively, when insecticide-treated nets and anti-malarial chemoprophylaxis were delivered, in addition to curative interventions. Conclusions CHW programmes could potentially achieve large gains in child survival in sub-Saharan Africa if these programmes were implemented at scale. Large-scale rigorous studies, including RCTs, are urgently needed to provide policymakers with more evidence on the effects of CHWs delivering these interventions.

Abstract Background Tuberculosis (TB) is a major contributor to the global burden of disease. In many settings, including South Africa, treatment outcomes remain poor. In contrast, many antiretroviral treatment (ART) programmes are achieving high levels of adherence and good outcomes. The ART programme model for maintaining treatment adherence may therefore hold promise for TB treatment. Changing treatment models, however, requires an assessment of how staff receive the new model, as they are responsible for programme implementation. Using the normalization process model as an analytic framework, this paper aims to explore staff perceptions of a new TB treatment programme modelled on the ART treatment programme. Methods A qualitative approach was used. Interviews and focus group discussions were conducted with clinic staff from five intervention clinics. Data were analysed initially using qualitative content analysis. The resulting categories were then organised under the constructs of the normalization process model. Results Staff recounted a number of challenges with implementing the programme. Interviews and focus group discussions identified factors relating to the main categories of the normalization process model. The key issues hindering the normalisation of the programme within clinics related to the interactional workability, relational integration and skill-set workability constructs of the model. These included hierarchical relationships, teamwork, training needs and insufficient internalisation by staff of the empowerment approach included in the programme. Logistical and management issues also impacted negatively on the normalization of the programme at the clinics. Conclusion The normalization process model assisted in categorising the challenges experienced during implementation of the intervention. The results suggest that issues remain that need to be resolved before the programme is implemented more widely. Considerable work is needed in order to embed the intervention in routine clinic practice.

Abstract Background Task shifting and the integration of human immunodeficiency virus (HIV) care into primary care services have been identified as possible strategies for improving access to antiretroviral treatment (ART). This paper describes the development and content of an intervention involving these two strategies, as part of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) pragmatic randomised controlled trial. Methods: Developing the intervention The intervention was developed following discussions with senior management, clinicians, and clinic staff. These discussions revealed that the establishment of separate antiretroviral treatment services for HIV had resulted in problems in accessing care due to the large number of patients at ART clinics. The intervention developed therefore combined the shifting from doctors to nurses of prescriptions of antiretrovirals (ARVs) for uncomplicated patients and the stepwise integration of HIV care into primary care services. Results: Components of the intervention The intervention consisted of regulatory changes, training, and guidelines to support nurse ART prescription, local management teams, an implementation toolkit, and a flexible, phased introduction. Nurse supervisors were equipped to train intervention clinic nurses in ART prescription using outreach education and an integrated primary care guideline. Management teams were set up and a STRETCH coordinator was appointed to oversee the implementation process. Discussion Three important processes were used in developing and implementing this intervention: active participation of clinic staff and local and provincial management, educational outreach to train nurses in intervention sites, and an external facilitator to support all stages of the intervention rollout. The STRETCH trial is registered with Current Control Trials ISRCTN46836853.

Abstract Background Qualitative research is used increasingly alongside trials of complex interventions to explore processes, contextual factors, or intervention characteristics that may have influenced trial outcomes. Qualitative research conducted alongside trials can also be used to shed light on the results of systematic reviews of effectiveness by looking for factors that can help explain heterogeneous results across trials. In a Cochrane review on the effects of using lay health workers on maternal and child health and infectious disease control, we identified 82 trials. These trials showed promising benefits but results were heterogeneous. Objective To use qualitative studies conducted alongside these trials to explore factors and processes that might have influenced intervention outcomes. Methods We attempted to identify qualitative research carried out alongside the trials by contacting trial authors, checking papers for references to qualitative research, searching Pubmed for related studies, and carrying out citation searches. For those qualitative studies that we included, we extracted information regarding study objective, data collection and analysis methods, and key themes and categories. Results For 52 (63%) of the trials, we found no qualitative research that had been conducted alongside the trials. For 16 (20%) trials, some form of qualitative data collection had been done but was unavailable or had been done before the trial. For 14 (17%) trials, qualitative research had been done during or shortly after the trial, although descriptions of qualitative methods and results were often sparse. Most of these 14 studies aimed to elicit trial participants' perspectives and experiences of the intervention. A common theme was participants' appreciation of the lay health workers' shared circumstances, for instance with regard to social background or experience of the health condition. In six studies, researchers explored the experiences of the lay health workers themselves. Issues included the importance of regular supervision and health professionals' support or lack of support. Conclusions Qualitative studies carried out alongside trials of complex interventions could offer opportunities to authors of systematic reviews of effectiveness wishing to understand the heterogeneity of trial results. For interventions of lay health worker programmes at least, too few such studies exist at present for these opportunities to be realised.

Abstract Background While the past two decades have seen a shift towards evidence-based obstetrics and midwifery, the process through which a culture of evidence-based practice develops and is sustained within particular fields of clinical practice has not been well documented, particularly in LMICs (low- and middle-income countries). Forming part of a broader qualitative study of evidence-based policy making, this paper describes the development of a culture of evidence-based practice amongst maternal health policy makers and senior academic obstetricians in South Africa Methods A qualitative case-study approach was used. This included a literature review, a policy document review, a timeline of key events and the collection and analysis of 15 interviews with policy makers and academic clinicians involved in these policy processes and sampled using a purposive approach. The data was analysed thematically. Results The concept of evidence-based medicine became embedded in South African academic obstetrics at a very early stage in relation to the development of the concept internationally. The diffusion of this concept into local academic obstetrics was facilitated by contact and exchange between local academic obstetricians, opinion leaders in international research and structures promoting evidence-based practice. Furthermore the growing acceptance of the concept was stimulated locally through the use of existing professional networks and meetings to share ideas and the contribution of local researchers to building the evidence base for obstetrics both locally and internationally. As a testimony to the extent of the diffusion of evidence-based medicine, South Africa has strongly evidence-based policies for maternal health. Conclusion This case study shows that the combined efforts of local and international researchers can create a culture of evidence-based medicine within one country. It also shows that doing so required time and perseverance from international researchers combined with a readiness by local researchers to receive and actively promote the practice.

Abstract Background The effectiveness of provider-initiated HIV testing and counseling (PITC) for patients with sexually transmitted infection (STI) in resource-constrained settings are of particular concern for high HIV prevalence countries like South Africa. This study evaluated whether the PITC approach increased HIV testing amongst patients with a new episode of sexually transmitted infection, as compared to standard voluntary counseling and testing (VCT) at the primary care level in South Africa, a high prevalence and low resource setting. Methods The design was a pragmatic cluster-controlled trial with seven intervention and 14 control clinics in Cape Town. Nurses in intervention clinics integrated PITC into standard HIV care with few additional resources, whilst lay counselors continued with the VCT approach in control clinics. Routine data were collected for a six-month period following the intervention in 2007, on new STI patients who were offered and who accepted HIV testing. The main outcome measure was the proportion of new STI patients tested for HIV, with secondary outcomes being the proportions who were offered and who declined the HIV test. Results A significantly higher proportion of new STI patients in the intervention group tested for HIV as compared to the control group with (56.4% intervention versus 42.6% control, p = 0.037). This increase was achieved despite a significantly higher proportion intervention group declining testing when offered (26.7% intervention versus 13.5% control, p = 0.0086). Patients were more likely to be offered HIV testing in intervention clinics, where providers offered the HIV test to 76.8% of new STI patients versus 50.9% in the control group (p = 0.0029). There was significantly less variation in the main outcomes across the intervention clinics, suggesting that the intervention also facilitated more consistent performance. Conclusions PITC was successful in three ways: it increased the proportion of new STI patients tested for HIV; it increased the proportion of new STI patients offered HIV testing; and it delivered more consistent performance across clinics. Recommendations are made for increasing the impact and feasibility of PITC in high HIV prevalence and resource-constrained settings. These include more flexible use of clinical and lay staff, and combining PITC with VCT and other community-based approaches to HIV testing. Trial registration Controlled trial ISRCTN93692532

Abstract Background Little is known about the process of knowledge translation in low- and middle-income countries. We studied policymaking processes in Mozambique, South Africa and Zimbabwe to understand the factors affecting the use of research evidence in national policy development, with a particular focus on the findings from randomized control trials (RCTs). We examined two cases: the use of magnesium sulphate (MgSO4) in the treatment of eclampsia in pregnancy (a clinical case); and the use of insecticide treated bed nets and indoor residual household spraying for malaria vector control (a public health case). Methods We used a qualitative case-study methodology to explore the policy making process. We carried out key informants interviews with a range of research and policy stakeholders in each country, reviewed documents and developed timelines of key events. Using an iterative approach, we undertook a thematic analysis of the data. Findings Prior experience of particular interventions, local champions, stakeholders and international networks, and the involvement of researchers in policy development were important in knowledge translation for both case studies. Key differences across the two case studies included the nature of the evidence, with clear evidence of efficacy for MgSO4 and ongoing debate regarding the efficacy of bed nets compared with spraying; local researcher involvement in international evidence production, which was stronger for MgSO4 than for malaria vector control; and a long-standing culture of evidence-based health care within obstetrics. Other differences were the importance of bureaucratic processes for clinical regulatory approval of MgSO4, and regional networks and political interests for malaria control. In contrast to treatment policies for eclampsia, a diverse group of stakeholders with varied interests, differing in their use and interpretation of evidence, was involved in malaria policy decisions in the three countries. Conclusion Translating research knowledge into policy is a complex and context sensitive process. Researchers aiming to enhance knowledge translation need to be aware of factors influencing the demand for different types of research; interact and work closely with key policy stakeholders, networks and local champions; and acknowledge the roles of important interest groups.

Abstract Background A recently updated Cochrane systematic review on the effects of lay or community health workers (LHWs) in primary and community health care concluded that LHW interventions could lead to promising benefits in the promotion of childhood vaccination uptake. However, understanding of the costs and cost-effectiveness of involving LHWs in vaccination programmes remains poor. This paper reviews the costs and cost-effectiveness of vaccination programme interventions involving LHWs. Methods Articles were retrieved if the title, keywords or abstract included terms related to 'lay health workers', 'vaccination' and 'economics'. Reference lists of studies assessed for inclusion were also searched and attempts were made to contact authors of all studies included in the Cochrane review. Studies were included after assessing eligibility of the full-text article. The included studies were then reviewed against a set of background and technical characteristics. Results Of the 2616 records identified, only three studies fully met the inclusion criteria, while an additional 11 were retained as they included some cost data. Methodologically, the studies were strong but did not adequately address affordability and sustainability and were also highly heterogeneous in terms of settings and LHW outcomes, limiting their comparability. There were insufficient data to allow any conclusions to be drawn regarding the cost-effectiveness of LHW interventions to promote vaccination uptake. Studies focused largely on health outcomes and did illustrate to some extent how the institutional characteristics of communities, such as governance and sources of financial support, influence sustainability. Conclusion The included studies suggest that conventional economic evaluations, particularly cost-effectiveness analyses, generally focus too narrowly on health outcomes, especially in the context of vaccination promotion and delivery at the primary health care level by LHWs. Further studies on the costs and cost-effectiveness of vaccination programmes involving LHWs should be conducted, and these studies should adopt a broader and more holistic approach.

Abstract Background Few empirical studies of research utilisation have been conducted in low and middle income countries. This paper explores how research information, in particular findings from randomised controlled trials and systematic reviews, informed policy making and clinical guideline development for the use of magnesium sulphate in the treatment of eclampsia and pre-eclampsia in South Africa. Methods A qualitative case-study approach was used to examine the policy process. This included a literature review, a policy document review, a timeline of key events and the collection and analysis of 15 interviews with policy makers and academic clinicians involved in these policy processes and sampled using a purposive approach. The data was analysed thematically and explored theoretically through the literature on agenda setting and the policy making process. Results Prior to 1994 there was no national maternal care policy in South Africa. Consequently each tertiary level institution developed its own care guidelines and these recommended a range of approaches to the management of pre-eclampsia and eclampsia. The subsequent emergence of new national policies for maternal care, including for the treatment of pre-eclampsia and eclampsia, was informed by evidence from randomised controlled trials and systematic reviews. This outcome was influenced by a number of factors. The change to a democratic government in the mid 1990s, and the health reforms that followed, created opportunities for maternal health care policy development. The new government was open to academic involvement in policy making and recruited academics from local networks into key policy making positions in the National Department of Health. The local academic obstetric network, which placed high value on evidence-based practice, brought these values into the policy process and was also linked strongly to international evidence based medicine networks. Within this context of openness to policy development, local researchers acted as policy entrepreneurs, bringing attention to priority health issues, and to the use of research evidence in addressing these. This resulted in the new national maternity care guidelines being informed by evidence from randomised controlled trials and recommending explicitly the use of magnesium sulphate for the management of eclampsia. Conclusion Networks of researchers were important not only in using research information to shape policy but also in placing issues on the policy agenda. A policy context which created a window of opportunity for new research-informed policy development was also crucial.

Abstract Background Qualitative synthesis has become more commonplace in recent years. Meta-ethnography is one of several methods for synthesising qualitative research and is being used increasingly within health care research. However, many aspects of the steps in the process remain ill-defined. Discussion We utilized the seven stages of the synthesis process to synthesise qualitative research on adherence to tuberculosis treatment. In this paper we discuss the methodological and practical challenges faced; of particular note are the methods used in our synthesis, the additional steps that we found useful in clarifying the process, and the key methodological challenges encountered in implementing the meta-ethnographic approach. The challenges included shaping an appropriate question for the synthesis; identifying relevant studies; assessing the quality of the studies; and synthesising findings across a very large number of primary studies from different contexts and research traditions. We offer suggestions that may assist in undertaking meta-ethnographies in the future. Summary Meta-ethnography is a useful method for synthesising qualitative research and for developing models that interpret findings across multiple studies. Despite its growing use in health research, further research is needed to address the wide range of methodological and epistemological questions raised by the approach.

Abstract Background Suboptimal treatment adherence remains a barrier to the control of many infectious diseases, including tuberculosis and HIV/AIDS, which contribute significantly to the global disease burden. However, few of the many interventions developed to address this issue explicitly draw on theories of health behaviour. Such theories could contribute to the design of more effective interventions to promote treatment adherence and to improving assessments of the transferability of these interventions across different health issues and settings. Methods This paper reviews behaviour change theories applicable to long-term treatment adherence; assesses the evidence for their effectiveness in predicting behaviour change; and examines the implications of these findings for developing strategies to improve TB and HIV/AIDS medication adherence. We searched a number of electronic databases for theories of behaviour change. Eleven theories were examined. Results Little empirical evidence was located on the effectiveness of these theories in promoting adherence. However, several models have the potential to both improve understanding of adherence behaviours and contribute to the design of more effective interventions to promote adherence to TB and HIV/AIDS medication. Conclusion Further research and analysis is needed urgently to determine which models might best improve adherence to long-term treatment regimens.

Abstract Background The evidence base for improving reproductive health continues to grow. However, concerns remain that the translation of this evidence into appropriate policies is partial and slow. Little is known about the factors affecting the use of evidence by policy makers and clinicians, particularly in developing countries. The objective of this study was to examine the factors that might affect the translation of randomised controlled trial (RCT) findings into policies and practice in developing countries. Methods The recent publication of an important RCT on the use of magnesium sulphate to treat pre-eclampsia provided an opportunity to explore how research findings might be translated into policy. A range of research methods, including a survey, group interview and observations with RCT collaborators and a survey of WHO drug information officers, regulatory officials and obstetricians in 12 countries, were undertaken to identify barriers and facilitators to knowledge translation. Results It proved difficult to obtain reliable data regarding the availability and use of commonly used drugs in many countries. The perceived barriers to implementing RCT findings regarding the use of magnesium sulphate for pre-eclampsia include drug licensing and availability; inadequate and poorly implemented clinical guidelines; and lack of political support for policy change. However, there were significant regional and national differences in the importance of specific barriers. Conclusion The policy changes needed to ensure widespread availability and use of magnesium sulphate are variable and complex. Difficulties in obtaining information on availability and use are combined with the wide range of barriers across settings, including a lack of support from policy makers. This makes it difficult to envisage any single intervention strategy that might be used to promote the uptake of research findings on magnesium sulphate into policy across the study settings. The publication of important trials may therefore not have the impacts on health care that researchers hope for.