Summary

Background

Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care.

Methods

We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (<400 copies per mL) 12 months after enrolment (equivalence analysis, prespecified difference <6%). Patients and clinicians could not be masked to group assignment. The interim analysis was blind, but data analysts were not masked after the database was locked for final analysis. Analyses were done by intention to treat. This trial is registered, number ISRCTN46836853.

Findings

5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group, and 3862 in cohort 1 and 3202 in cohort 2 were in the control group. Median follow-up was 16·3 months (IQR 12·2–18·0) in cohort 1 and 18·0 months (18·0–18·0) in cohort 2. In cohort 1, 997 (20%) of 4943 patients analysed in the intervention group and 747 (19%) of 3862 in the control group with known vital status at the end of the trial had died. Time to death did not differ (hazard ratio [HR] 0·94, 95% CI 0·76–1·15). In a preplanned subgroup analysis of patients with baseline CD4 counts of 201–350 cells per μL, mortality was slightly lower in the intervention group than in the control group (0·73, 0·54–1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less (0·94, 0·76–1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI −2·4 to 4·6).

Interpretation

Expansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality.

Funding

UK Medical Research Council, Development Cooperation Ireland, and Canadian International Development Agency.

Background

Tuberculosis rates in the world remain high, especially in low- and middle-income countries. International tuberculosis (TB) policy generally recommends the use of directly observed therapy (DOT) to ensure treatment adherence.

Objective

This article examines a change in TB treatment support that occurred in 2005 in South Africa, from DOT to the enhanced TB adherence programme (ETA).

Design

Seven key individuals representing academics, policy makers and service providers involved in the development of the ETA programme or knowledgeable about the issue were purposively sampled and interviewed, and participant observation was conducted at ETA programme steering group meetings. Qualitative content analysis was used to analyse the data, drawing on the Kingdon model of agenda setting. This model suggests that three independent streams – problem, policy and politics – come together at a certain point, often facilitated by policy entrepreneurs, to provide an opportunity for an issue to enter the policy agenda.

Results

The results suggest the empowerment-oriented programme emerged through the presence of policy entrepreneurs with access to resources. Policy entrepreneurs were influenced by a number of simultaneously occurring challenges including problems within the existing programme; a perceived mismatch between patient needs and the existing TB treatment model; and the TB-HIV co-epidemic. Policy entrepreneurs saw the ART approach as a possible solution to these challenges.

Conclusions

The Kingdon model contributed to describing the process of policy change. Research evidence seemed to influence this change diffusely, through the interaction of policy entrepreneurs and academics.

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

In the third paper in a three-part series on health systems guidance, Simon Lewin and colleagues explore the challenge of assessing how much confidence to place in evidence on health systems interventions.

In the second paper in a three-part series on health systems guidance, John Lavis and colleagues explore the challenge of linking guidance development and policy development at global and national levels.

In the first paper in a three-part series on health systems guidance, Xavier Bosch-Capblanch and colleagues examine how guidance is currently formulated in low- and middle-income countries, and the challenges to developing such guidance.

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.

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.

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.

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.

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.

Objective To investigate whether PALSA PLUS, an on-site educational outreach programme of non-didactic, case based, iterative clinical education of staff, led by a trainer, can increase access to and comprehensiveness of care for patients with HIV/AIDS.

Design Cluster randomised trial.

Setting Public primary care clinics offering HIV/AIDS care, antiretroviral treatment (ART), tuberculosis care, and ambulatory primary care in Free State province, South Africa.

Participants Fifteen clinics all implementing decentralisation and task shifting were randomised. The clinics cared for 400 000 general primary care patients and 10 136 patients in an HIV/AIDS/ART programme. There were 150 nurses.

Intervention On-site outreach education in eight clinics; no such education in seven (control).

Main outcome measures Provision of co-trimoxazole prophylaxis among patients referred to the HIV/AIDS/ART programme, and detection of cases of tuberculosis among those in the programme. Proportion of patients in the programme enrolled through general primary care consultations.

Results Patients referred to the HIV/AIDS programme through general primary care at intervention clinics were more likely than those at control clinics to receive co-trimoxazole prophylaxis (41%, (2253/5523) v 32% (1340/4210); odds ratio 1.95, 95% confidence interval 1.11 to 3.40), and tuberculosis was more likely to be diagnosed among patients with HIV/AIDS/ART (7% (417/5793) v 6% (245/4343); 1.25, 1.01 to 1.55). Enrolment in the HIV/AIDS and ART programme through HIV testing in general primary care was not significantly increased (53% v 50%; 1.19, 0.51 to 2.77). Secondary outcomes were similar, except for weight gain, which was higher in the intervention group (2.3 kg v 1.9 kg, P<0.001).

Conclusion Though outreach education is an effective and feasible strategy for improving comprehensiveness of care and wellbeing of patients with HIV/AIDS, there is no evidence that it increases access to the ART programme. It is now being widely implemented in South Africa.

Trial registration Current Controlled Trials ISRCTN 24820584.

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.

There is re-emerging interest in community health workers (CHWs) as part of wider policies regarding task-shifting within human resources for health. This paper examines the history of CHW programmes established in South Africa in the later apartheid years (1970s–1994) – a time of innovative initiatives. After 1994, the new democratic government embraced primary healthcare (PHC), however CHW initiatives were not included in their health plan and most of these programmes subsequently collapsed. Since then a wide array of disease-focused CHW projects have emerged, particularly within HIV care.

Thirteen oral history interviews and eight witness seminars were conducted in South Africa in April 2008 with founders and CHWs from these earlier programmes. These data were triangulated with written primary sources and analysed using thematic content analysis. The study suggests that 1970s–1990s CHW programmes were seen as innovative, responsive, comprehensive and empowering for staff and communities, a focus which respondents felt was lost within current programmes. The growth of these earlier projects was underpinned by the struggle against apartheid. Respondents felt that the more technical focus of current CHW programmes under-utilise a valuable human resource which previously had a much wider social and health impact. These prior experiences and lessons learned could usefully inform policy-making frameworks for CHWs in South Africa today.

Introduction Indoor residual spraying (IRS) and insecticide-treated nets (ITNs), two principal malaria control strategies, are similar in cost and efficacy. We aimed to describe recent policy development regarding their use in Mozambique, South Africa and Zimbabwe.

Methods Using a qualitative case study methodology, we undertook semi-structured interviews of key informants from May 2004 to March 2005, carried out document reviews and developed timelines of key events. We used an analytical framework that distinguished three broad categories: interests, ideas and events.

Results A disparate mix of interests and ideas slowed the uptake of ITNs in Mozambique and Zimbabwe and prevented uptake in South Africa. Most respondents strongly favoured one strategy over the other. In all three countries, national policy makers favoured IRS, and only in Mozambique did national researchers support ITNs. Outside interests in favour of IRS included manufacturers who supplied the insecticides and groups opposing environmental regulation. International research networks, multilateral organizations, bilateral donors and international NGOs supported ITNs. Research evidence, local conditions, logistic feasibility, past experience, reaction to outside ideas, community acceptability, the role of government and NGOs, and harm from insecticides used in spraying influenced the choice of strategy. The end of apartheid permitted a strongly pro-IRS South Africa to influence the region, and in Mozambique and Zimbabwe, floods provided conditions conducive to ITN distribution.

Conclusions Both IRS and ITNs have a place in integrated malaria vector management, but pro-IRS interests and ideas slowed or prevented the uptake of ITNs. Policy makers needed more than evidence from trials to change from the time-honoured IRS strategy that they perceived was working. Those intending to promote new policies such as ITNs should examine the interests and ideas motivating key stakeholders and their own institutions, and identify where shifts in thinking or coalitions among the like-minded may be possible.

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

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.

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 the use of evidence to inform judgements about the balance between the pros and cons of policy and programme options. We suggest five questions that can be considered when making these judgements. These are: 1. What are the options that are being compared? 2. What are the most important potential outcomes of the options being compared? 3. What is the best estimate of the impact of the options being compared for each important outcome? 4. How confident can policymakers and others be in the estimated impacts? 5. Is a formal economic model likely to facilitate decision making?

This article is the Introduction to a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers.

Knowing how to find and use research evidence can help policymakers and those who support them to do their jobs better and more efficiently. Each article in this series presents a proposed tool that can be used by those involved in finding and using research evidence to support evidence-informed health policymaking. The series addresses four broad areas: 1. Supporting evidence-informed policymaking 2. Identifying needs for research evidence in relation to three steps in policymaking processes, namely problem clarification, options framing, and implementation planning 3. Finding and assessing both systematic reviews and other types of evidence to inform these steps, and 4. Going from research evidence to decisions. Each article begins with between one and three typical scenarios relating to the topic. These scenarios are designed to help readers decide on the level of detail relevant to them when applying the tools described. Most articles in this series are structured using a set of questions that guide readers through the proposed tools and show how to undertake activities to support evidence-informed policymaking efficiently and effectively. These activities include, for example, using research evidence to clarify problems, assessing the applicability of the findings of a systematic review about the effects of options selected to address problems, organising and using policy dialogues to support evidence-informed policymaking, and planning policy monitoring and evaluation. In several articles, the set of questions presented offers more general guidance on how to support evidence-informed policymaking. Additional information resources are listed and described in every article. The evaluation of ways to support evidence-informed health policymaking is a developing field and feedback about how to improve the series is welcome.

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 discuss the following three questions: What is evidence? What is the role of research evidence in informing health policy decisions? What is evidence-informed policymaking?

Evidence-informed health policymaking is an approach to policy decisions that aims to ensure that decision making is well-informed by the best available research evidence. It is characterised by the systematic and transparent access to, and appraisal of, evidence as an input into the policymaking process. The overall process of policymaking is not assumed to be systematic and transparent. However, within the overall process of policymaking, systematic processes are used to ensure that relevant research is identified, appraised and used appropriately. These processes are transparent in order to ensure that others can examine what research evidence was used to inform policy decisions, as well as the judgements made about the evidence and its implications. Evidence-informed policymaking helps policymakers gain an understanding of these processes.

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 of equity. Inequities can be defined as "differences in health which are not only unnecessary and avoidable but, in addition, are considered unfair and unjust". These have been well documented in relation to social and economic factors. Policies or programmes that are effective can improve the overall health of a population. However, the impact of such policies and programmes on inequities may vary: they may have no impact on inequities, they may reduce inequities, or they may exacerbate them, regardless of their overall effects on population health.

We suggest four questions that can be considered when using research evidence to inform considerations of the potential impact a policy or programme option is likely to have on disadvantaged groups, and on equity in a specific setting. These are: 1. Which groups or settings are likely to be disadvantaged in relation to the option being considered? 2. Are there plausible reasons for anticipating differences in the relative effectiveness of the option for disadvantaged groups or settings? 3. Are there likely to be different baseline conditions across groups or settings such that that the absolute effectiveness of the option would be different, and the problem more or less important, for disadvantaged groups or settings? 4. Are there important considerations that should be made when implementing the option in order to ensure that inequities are reduced, if possible, and that they are not increased?

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.

Evidence about local conditions is evidence that is available from the specific setting(s) in which a decision or action on a policy or programme option will be taken. Such evidence is always needed, together with other forms of evidence, in order to inform decisions about options. Global evidence is the best starting point for judgements about effects, factors that modify those effects, and insights into ways to approach and address problems. But local evidence is needed for most other judgements about what decisions and actions should be taken. In this article, we suggest five questions that can help to identify and appraise the local evidence that is needed to inform a decision about policy or programme options. These are: 1. What local evidence is needed to inform a decision about options? 2. How can the necessary local evidence be found? 3. How should the quality of the available local evidence be assessed? 4. Are there important variations in the availability, quality or results of local evidence? 5. How should local evidence be incorporated with other information?

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?

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 briefs are a relatively new approach to packaging research evidence for policymakers. The first step in a policy brief is to prioritise a policy issue. Once an issue is prioritised, the focus then turns to mobilising the full range of research evidence relevant to the various features of the issue. Drawing on available systematic reviews makes the process of mobilising evidence feasible in a way that would not otherwise be possible if individual relevant studies had to be identified and synthesised for every feature of the issue under consideration. In this article, we suggest questions that can be used to guide those preparing and using policy briefs to support evidence-informed policymaking. These are: 1. Does the policy brief address a high-priority issue and describe the relevant context of the issue being addressed? 2. Does the policy brief describe the problem, costs and consequences of options to address the problem, and the key implementation considerations? 3. Does the policy brief employ systematic and transparent methods to identify, select, and assess synthesised research evidence? 4. Does the policy brief take quality, local applicability, and equity considerations into account when discussing the synthesised research evidence? 5. Does the policy brief employ a graded-entry format? 6. Was the policy brief reviewed for both scientific quality and system relevance?

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?