Incorporating Demand and Supply Constraints into Economic Evaluations in Low-Income and Middle-Income Countries.

Global guidelines for new technologies are based on cost and efficacy data from a limited number of trial locations. Country-level decision makers need to consider whether cost-effectiveness analysis used to inform global guidelines are sufficient for their situation or whether to use models that adjust cost-effectiveness results taking into account setting-specific epidemiological and cost heterogeneity. However, demand and supply constraints will also impact cost-effectiveness by influencing the standard of care and the use and implementation of any new technology. These constraints may also vary substantially by setting. We present two case studies of economic evaluations of the introduction of new diagnostics for malaria and tuberculosis control. These case studies are used to analyse how the scope of economic evaluations of each technology expanded to account for and then address demand and supply constraints over time. We use these case studies to inform a conceptual framework that can be used to explore the characteristics of intervention complexity and the influence of demand and supply constraints. Finally, we describe a number of feasible steps that researchers who wish to apply our framework in cost-effectiveness analyses.

A qualitative study on health workers' and community members' perceived sources, role of information and communication on malaria treatment, prevention and control in southeast Nigeria.

BACKGROUND: It has been widely acknowledged that well-planned and executed communication programmes can contribute to achieving malaria prevention and treatment goals. This however requires a good understanding of current sources and roles of information used by both health workers and communities. The study aimed at determining health workers' and community members' sources, value and use of information on malaria prevention and treatment in Nigeria. METHODS: Qualitative data was collected from six selected communities (three urban and three rural) in Enugu state, southeast Nigeria. A total of 18 Focus Group Discussions (FGDs) with 179 community members and 26 in-depth interviews (IDIs) with health workers in public and private health facilities were used to collect data on where people receive treatment for malaria and access information on malaria. The FGDS and IDIs also provided data on the values, uses and effects of information and communication on malaria treatment seeking and provision of services. RESULTS: The findings revealed that the major sources of information on malaria for health workers and community members were advertisements in the mass media, workshops and seminars organized by donor agencies, facility supervision, posters, other health workers, television and radio adverts. Community involvement in the design and delivery of information on malaria control was seen as a strong strategy for improving both consumer and provider knowledge. Information from the different sources catalyzed appropriate provision and consumption of malaria treatment amongst health workers and community members. CONCLUSION: Health workers and consumers receive information on malaria prevention and treatment from multiple sources of communication and information, which they find useful. Harnessing these information sources to encourage consistent and accurate messages around malaria prevention and treatment is a necessary first step in the design and implementation of malaria communication and behaviour change interventions and ultimately for the sustained control of malaria.

Quality of care for the treatment for uncomplicated malaria in South-East Nigeria: how important is socioeconomic status?

INTRODUCTION: Ensuring equitable coverage of appropriate malaria treatment remains a high priority for the Nigerian government. This study examines the health seeking behaviour, patient-provider interaction and quality of care received by febrile patients of different socio-economic status (SES) groups. METHODS: A total of 1642 febrile patients and caregivers exiting public health centres, pharmacies and patent medicine dealers were surveyed in Enugu state, South-East Nigeria to obtain information on treatment seeking behaviour, patient-provider interactions and treatment received. Socioeconomic status was estimated for each patient using exit survey data on household assets in combination with asset ownership data from the 2008 Nigeria Demographic and Health Survey. RESULTS: Among the poorest SES group, 29% sought treatment at public health centres, 13% at pharmacies and 58% at patent medicine dealers (p < 0.01). Very few of those in the richest SES group used public health centres (4%) instead choosing to go to pharmacies (44%) and patent medicine dealers (52%, p < 0.001). During consultations with a healthcare provider, the poorest compared to the richest were significantly more likely to discuss symptoms with the provider, be physically examined and rely on providers for diagnosis and treatment rather than request a specific medicine. Those from the poorest SES group were however, least likely to request or to receive an antimalarial (p < 0.001). The use of artemisinin combination therapy (ACT), the recommended treatment for uncomplicated malaria, was low across all SES groups. CONCLUSIONS: The quality of malaria treatment is sub-optimal for all febrile patients. Having greater interaction with the provider also did not translate to better quality care for the poor. The poor face a number of significant barriers to accessing quality treatment especially in relation to treatment seeking behaviour and type of treatment received. Strategies to address these inequities are fundamental to achieving universal coverage of effective malaria treatment and ensuring that the most vulnerable people are not left behind.

Evaluation of a universal long-lasting insecticidal net (LLIN) distribution campaign in Ghana: cost effectiveness of distribution and hang-up activities.

BACKGROUND: Between May 2010 and October 2012, approximately 12.5 million long-lasting insecticidal nets (LLINs) were distributed through a national universal mass distribution campaign in Ghana. The campaign included pre-registration of persons and sleeping places, door-to-door distribution of LLINs with 'hang-up' activities by volunteers and post-distribution 'keep-up' behaviour change communication activities. Hang-up activities were included to encourage high and sustained use. METHODS: The cost and cost-effectiveness of the LLIN Campaign were evaluated using a before-after design in three regions: Brong Ahafo, Central and Western. The incremental cost effectiveness of the 'hang-up' component was estimated using reported variation in the implementation of hang-up activities and LLIN use. Economic costs were estimated from a societal perspective assuming LLINs would be replaced after three years, and included the time of unpaid volunteers and household contributions given to volunteers. RESULTS: Across the three regions, 3.6 million campaign LLINs were distributed, and 45.5% of households reported the LLINs received were hung-up by a volunteer. The financial cost of the campaign was USD 6.51 per LLIN delivered. The average annual economic cost was USD 2.90 per LLIN delivered and USD 6,619 per additional child death averted by the campaign. The cost-effectiveness of the campaign was sensitive to the price, lifespan and protective efficacy of LLINs.Hang-up activities constituted 7% of the annual economic cost, though the additional financial cost was modest given the use of volunteers. LLIN use was greater in households in which one or more campaign LLINs were hung by a volunteer (OR=1.57; 95% CI=1.09, 2.27; p=0.02). The additional economic cost of the hang-up activities was USD 0.23 per LLIN delivered, and achieved a net saving per LLIN used and per death averted. CONCLUSION: In this campaign, hang-up activities were estimated to be net saving if hang-up increased LLIN use by 10% or more. This suggests hang-up activities can make a LLIN campaign more cost-effective.

Designing and implementing interventions to change clinicians' practice in the management of uncomplicated malaria: lessons from Cameroon.

BACKGROUND: Effective case management of uncomplicated malaria is a fundamental pillar of malaria control. Little is known about the various steps in designing interventions to accompany the roll out of rapid diagnostic tests (RDTs) and artemisinin-based combination therapy (ACT). This study documents the process of designing and implementing interventions to change clinicians' practice in the management of uncomplicated malaria. METHODS: A literature review combined with formative quantitative and qualitative research were carried out to determine patterns of malaria diagnosis and treatment and to understand how malaria and its treatment are enacted by clinicians. These findings were used, alongside a comprehensive review of previous interventions, to identify possible strategies for changing the behaviour of clinicians when diagnosing and treating uncomplicated malaria. These strategies were discussed with ministry of health representatives and other stakeholders. Two intervention packages - a basic and an enhanced training were outlined, together with logic model to show how each was hypothesized to increase testing for malaria, improve adherence to test results and increase appropriate use of ACT. The basic training targeted clinicians' knowledge of malaria diagnosis, rapid diagnostic testing and malaria treatment. The enhanced training included additional modules on adapting to change, professionalism and communicating effectively. Modules were delivered using small-group work, card games, drama and role play. Interventions were piloted, adapted and trainers were trained before final implementation. RESULTS: Ninety-six clinicians from 37 health facilities in Bamenda and Yaounde sites attended either 1-day basic or 3-day enhanced training. The trained clinicians then trained 632 of their peers at their health facilities. Evaluation of the training revealed that 68% of participants receiving the basic and 92% of those receiving the enhanced training strongly agreed that it is not appropriate to prescribe anti-malarials to a patient if they have a negative RDT result. CONCLUSION: Formative research was an important first step, and it was valuable to engage stakeholders early in the process. A logic model and literature reviews were useful to identify key elements and mechanisms for behaviour change intervention. An iterative process with feedback loops allowed appropriate development and implementation of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01350752.

Economic evaluation of a cluster randomized trial of interventions to improve health workers' practice in diagnosing and treating uncomplicated malaria in Cameroon.

BACKGROUND: Malaria rapid diagnostic tests (RDTs) are a valid alternative to malaria testing with microscopy and are recommended for the testing of febrile patients before prescribing an antimalarial. There is a need for interventions to support the uptake of RDTs by health workers. OBJECTIVE: To evaluate the cost-effectiveness of introducing RDTs with basic or enhanced training in health facilities in which microscopy was available, compared with current practice. METHODS: A three-arm cluster randomized trial was conducted in 46 facilities in central and northwest Cameroon. Basic training had a practical session on RDTs and lectures on malaria treatment guidelines. Enhanced training included small-group activities designed to change health workers' practice and reduce the consumption of antimalarials among test-negative patients. The primary outcome was the proportion of febrile patients correctly treated: febrile patients should be tested for malaria, artemisinin combination therapy should be prescribed for confirmed cases, and no antimalarial should be prescribed for patients who are test-negative. Individual patient data were obtained from facility records and an exit survey. Costs were estimated from a societal perspective using project reports and patient exit data. The analysis used bivariate multilevel modeling and adjusted for imbalance in baseline covariates. RESULTS: Incremental cost per febrile patient correctly treated was $8.40 for the basic arm and $3.71 for the enhanced arm. On scale-up, it was estimated that RDTs with enhanced training would save $0.75 per additional febrile patient correctly treated. CONCLUSIONS: Introducing RDTs with enhanced training was more cost-effective than RDTs with basic training when each was compared with current practice.

Cost-effectiveness of strategies to improve the utilization and provision of maternal and newborn health care in low-income and lower-middle-income countries: a systematic review.

BACKGROUND: Each year almost 3 million newborns die within the first 28 days of life, 2.6 million babies are stillborn, and 287,000 women die from complications of pregnancy and childbirth worldwide. Effective and cost-effective interventions and behaviours for mothers and newborns exist, but their coverage remains inadequate in low- and middle-income countries, where the vast majority of deaths occur. Cost-effective strategies are needed to increase the coverage of life-saving maternal and newborn interventions and behaviours in resource-constrained settings. METHODS: A systematic review was undertaken on the cost-effectiveness of strategies to improve the demand and supply of maternal and newborn health care in low-income and lower-middle-income countries. Peer-reviewed and grey literature published since 1990 was searched using bibliographic databases, websites of selected organizations, and reference lists of relevant studies and reviews. Publications were eligible for inclusion if they report on a behavioural or health systems strategy that sought to improve the utilization or provision of care during pregnancy, childbirth or the neonatal period; report on its cost-effectiveness; and were set in one or more low-income or lower-middle-income countries. The quality of the publications was assessed using the Consolidated Health Economic Evaluation Reporting Standards statement. Incremental cost per life-year saved and per disability-adjusted life-year averted were compared to gross domestic product per capita. RESULTS: Forty-eight publications were identified, which reported on 43 separate studies. Sixteen were judged to be of high quality. Common themes were identified and the strategies were presented in relation to the continuum of care and the level of the health system. There was reasonably strong evidence for the cost-effectiveness of the use of women's groups, home-based newborn care using community health workers and traditional birth attendants, adding services to routine antenatal care, a facility-based quality improvement initiative to enhance compliance with care standards, and the promotion of breastfeeding in maternity hospitals. Other strategies reported cost-effectiveness measures that had limited comparability. CONCLUSION: Demand and supply-side strategies to improve maternal and newborn health care can be cost-effective, though the evidence is limited by the paucity of high quality studies and the use of disparate cost-effectiveness measures. TRIAL REGISTRATION: PROSPERO_ CRD42012003255.

How do health extension workers in Ethiopia allocate their time?

BACKGROUND: Governments are increasingly reliant on community health workers to undertake health promotion and provide essential curative care. In 2003, the Government of Ethiopia launched the Health Extension Programme and introduced a new cadre, health extension workers (HEWs), to improve access to care in rural communities. In 2013, to inform the government's plans for HEWs to take on an enhanced role in community-based newborn care, a time and motion study was conducted to understand the range of HEW responsibilities and how they allocate their time across health and non-health activities. METHODS: The study was administered in 69 rural kebeles in the Southern Nations Nationalities and People's Region and Oromia Region that were intervention areas of a trial to evaluate a package of community-based interventions for newborns. Over 4 consecutive weeks, HEWs completed a diary and recorded all activities undertaken during each working day. HEWs were also surveyed to collect data on seasonal activities and details of the health post and kebele in which they work. The average proportion of productive time (excluding breaks) that HEWs spent on an activity, at a location, or with a recipient each week, was calculated. RESULTS: The self-reported diary was completed by 131 HEWs. Over the course of a week, HEWs divided their time between the health post (51%) and the community (37%), with the remaining 11% of their time spent elsewhere. Curative health activities represented 16% of HEWs' time each week and 43% of their time was spent on health promotion and prevention. The remaining time included travel, training and supervision, administration, and community meetings. HEWs spent the majority (70%) of their time with individuals, families, and community members. CONCLUSIONS: HEWs have wide-ranging responsibilities for community-based health promotion and curative care. Their workload is diverse and they spend time on activities relating to family health, disease prevention and control, hygiene and sanitation, as well as other community-based activities. Reproductive, maternal, newborn, and child health activities represent a major component of the HEW's work and, as such, they can have a critically important role in improving the health outcomes of mothers and children in Ethiopia.

A strategy for reducing maternal and newborn deaths by 2015 and beyond.

BACKGROUND: Achievement of Millennium Development Goal (MDG) 4 for child survival requires acceleration of gains in newborn survival, and current trends in improving maternal health will also fall short of reaching MDG 5 without more strategic actions. We present a Maternal Newborn and Child Health (MNCH) strategy for accelerating progress on MDGs 4 and 5, sustaining the gains beyond 2015, and further bringing down maternal and child mortality by two thirds by 2030. DISCUSSION: The strategy takes into account current trends in coverage and cause-specific mortality, builds on lessons learned about what works in large-scale implementation programs, and charts a course to reach those who do not yet access services. A central hypothesis of this strategy is that enhancing interactions between frontline workers and mothers and families is critical for increasing the effective coverage of life-saving interventions. We describe a framework for measuring and evaluating progress which enables continuous course correction and improvement in program performance and impact. SUMMARY: Evidence for the hypothesis and impact of this strategy is being gathered and will be synthesized and disseminated in order to advance global learning and to maximise the potential to improve maternal and neonatal survival.

Exploring health providers' and community perceptions and experiences with malaria tests in South-East Nigeria: a critical step towards appropriate treatment.

BACKGROUND: The adoption of ACT as the first line treatment for uncomplicated malaria in Nigeria has concentrated attention on the role of testing in appropriate malaria treatment. There are calls at both national and global level for malaria treatment to be based on test result, but it is still unclear how testing can be incorporated into treatment-seeking and practices of health providers. This study explored community members and health providers' perceptions and experiences with malaria tests in south east Nigeria. METHODS: The study was conducted in urban and rural areas of Enugu state in south-eastern Nigeria. A total of 18 focus group discussions with 179 community members including sub-groups of primary caregivers, adult men and adult women aged 15 years and above. Twenty-six (26) In-depth interviews were held with public and private health providers involved in prescribing medicines at public and private health facilities in the study area. RESULTS: Both providers and community members were familiar with malaria tests and identified malaria tests as an important step to distinguish malaria from other illnesses with similar symptoms and as a means of delivering appropriate treatment. However, the logic of test-directed treatment was undermined by cost of test and a lack of testing facilities but above all concerns over the reliability of negative test results, with community members and providers observing inconsistencies between results and symptoms, and providers attributing inaccurate results to incompetencies of technicians. Recognition of malaria symptoms was deemed most important in determining the use of antimalarial drugs rather than the result of a malaria test. CONCLUSION: The results highlight important areas of intervention to promote appropriate malaria treatment. If tests are to play a role in patient management, demand and supply side interventions are needed to change people's attitude towards malaria test results.

The Impact of Introducing Malaria Rapid Diagnostic Tests on Fever Case Management: A Synthesis of Ten Studies from the ACT Consortium.

Since 2010, the World Health Organization has been recommending that all suspected cases of malaria be confirmed with parasite-based diagnosis before treatment. These guidelines represent a paradigm shift away from presumptive antimalarial treatment of fever. Malaria rapid diagnostic tests (mRDTs) are central to implementing this policy, intended to target artemisinin-based combination therapies (ACT) to patients with confirmed malaria and to improve management of patients with nonmalarial fevers. The ACT Consortium conducted ten linked studies, eight in sub-Saharan Africa and two in Afghanistan, to evaluate the impact of mRDT introduction on case management across settings that vary in malaria endemicity and healthcare provider type. This synthesis includes 562,368 outpatient encounters (study size range 2,400-432,513). mRDTs were associated with significantly lower ACT prescription (range 8-69% versus 20-100%). Prescribing did not always adhere to malaria test results; in several settings, ACTs were prescribed to more than 30% of test-negative patients or to fewer than 80% of test-positive patients. Either an antimalarial or an antibiotic was prescribed for more than 75% of patients across most settings; lower antimalarial prescription for malaria test-negative patients was partly offset by higher antibiotic prescription. Symptomatic management with antipyretics alone was prescribed for fewer than 25% of patients across all scenarios. In community health worker and private retailer settings, mRDTs increased referral of patients to other providers. This synthesis provides an overview of shifts in case management that may be expected with mRDT introduction and highlights areas of focus to improve design and implementation of future case management programs.

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

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

Mind the gap: knowledge and practice of providers treating uncomplicated malaria at public and mission health facilities, pharmacies and drug stores in Cameroon and Nigeria.

BACKGROUND: Artemisinin combination therapy (ACT) has been the first-line treatment for uncomplicated malaria in Cameroon since 2004 and Nigeria since 2005, though many febrile patients receive less effective antimalarials. Patients often rely on providers to select treatment, and interventions are needed to improve providers' practice and encourage them to adhere to clinical guidelines. METHODS: Providers' adherence to malaria treatment guidelines was examined using data collected in Cameroon and Nigeria at public and mission facilities, pharmacies and drug stores. Providers' choice of antimalarial was investigated separately for each country. Multilevel logistic regression was used to determine whether providers were more likely to choose ACT if they knew it was the first-line antimalarial. Multiple imputation was used to impute missing data that arose when linking exit survey responses to details of the provider responsible for selecting treatment. RESULTS: There was a gap between providers' knowledge and their practice in both countries, as providers' decision to supply ACT was not significantly associated with knowledge of the first-line antimalarial. Providers were, however, more likely to supply ACT if it was the type of antimalarial they prefer. Other factors were country-specific, and indicated providers can be influenced by what they perceived their patients prefer or could afford, as well as information about their symptoms, previous treatment, the type of outlet and availability of ACT. CONCLUSIONS: Public health interventions to improve the treatment of uncomplicated malaria should strive to change what providers prefer, rather than focus on what they know. Interventions to improve adherence to malaria treatment guidelines should emphasize that ACT is the recommended antimalarial, and it should be used for all patients with uncomplicated malaria. Interventions should also be tailored to the local setting, as there were differences between the two countries in providers' choice of antimalarial, and who or what influenced their practice.

Effectiveness of Provider and Community Interventions to Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized Controlled Trial.

UNLABELLED: The World Health Organization recommends that malaria be confirmed by parasitological diagnosis before treatment using Artemisinin-based Combination Therapy (ACT). Despite this, many health workers in malaria endemic countries continue to diagnose malaria based on symptoms alone. This study evaluates interventions to help bridge this gap between guidelines and provider practice. A stratified cluster-randomized trial in 42 communities in Enugu state compared 3 scenarios: Rapid Diagnostic Tests (RDTs) with basic instruction (control); RDTs with provider training (provider arm); and RDTs with provider training plus a school-based community intervention (provider-school arm). The primary outcome was the proportion of patients treated according to guidelines, a composite indicator requiring patients to be tested for malaria and given treatment consistent with the test result. The primary outcome was evaluated among 4946 (93%) of the 5311 patients invited to participate. A total of 40 communities (12 in control, 14 per intervention arm) were included in the analysis. There was no evidence of differences between the three arms in terms of our composite indicator (p = 0.36): stratified risk difference was 14% (95% CI -8.3%, 35.8%; p = 0.26) in the provider arm and 1% (95% CI -21.1%, 22.9%; p = 0.19) in the provider-school arm, compared with control. The level of testing was low across all arms (34% in control; 48% provider arm; 37% provider-school arm; p = 0.47). Presumptive treatment of uncomplicated malaria remains an ingrained behaviour that is difficult to change. With or without extensive supporting interventions, levels of testing in this study remained critically low. Governments and researchers must continue to explore alternative ways of encouraging providers to deliver appropriate treatment and avoid the misuse of valuable medicines. TRIAL REGISTRATION: ClinicalTrials.gov NCT01350752.

What determines providers' stated preference for the treatment of uncomplicated malaria?

As agents for their patients, providers often make treatment decisions on behalf of patients, and their choices can affect health outcomes. However, providers operate within a network of relationships and are agents not only for their patients, but also other health sector actors, such as their employer, the Ministry of Health, and pharmaceutical suppliers. Providers' stated preferences for the treatment of uncomplicated malaria were examined to determine what factors predict their choice of treatment in the absence of information and institutional constraints, such as the stock of medicines or the patient's ability to pay. 518 providers working at non-profit health facilities and for-profit pharmacies and drug stores in Yaoundé and Bamenda in Cameroon and in Enugu State in Nigeria were surveyed between July and December 2009 to elicit the antimalarial they prefer to supply for uncomplicated malaria. Multilevel modelling was used to determine the effect of financial and non-financial incentives on their preference, while controlling for information and institutional constraints, and accounting for the clustering of providers within facilities and geographic areas. 69% of providers stated a preference for artemisinin-combination therapy (ACT), which is the recommended treatment for uncomplicated malaria in Cameroon and Nigeria. A preference for ACT was significantly associated with working at a for-profit facility, reporting that patients prefer ACT, and working at facilities that obtain antimalarials from drug company representatives. Preferences were similar among colleagues within a facility, and among providers working in the same locality. Knowing the government recommends ACT was a significant predictor, though having access to clinical guidelines was not sufficient. Providers are agents serving multiple principals and their preferences over alternative antimalarials were influenced by patients, drug company representatives, and other providers working at the same facility and in the local area. Efforts to disseminate drug policy should target the full range of actors involved in supplying drugs, including providers, employers, suppliers and local communities.

'Scaling-up is a craft not a science': Catalysing scale-up of health innovations in Ethiopia, India and Nigeria.

Donors and other development partners commonly introduce innovative practices and technologies to improve health in low and middle income countries. Yet many innovations that are effective in improving health and survival are slow to be translated into policy and implemented at scale. Understanding the factors influencing scale-up is important. We conducted a qualitative study involving 150 semi-structured interviews with government, development partners, civil society organisations and externally funded implementers, professional associations and academic institutions in 2012/13 to explore scale-up of innovative interventions targeting mothers and newborns in Ethiopia, the Indian state of Uttar Pradesh and the six states of northeast Nigeria, which are settings with high burdens of maternal and neonatal mortality. Interviews were analysed using a common analytic framework developed for cross-country comparison and themes were coded using Nvivo. We found that programme implementers across the three settings require multiple steps to catalyse scale-up. Advocating for government to adopt and finance health innovations requires: designing scalable innovations; embedding scale-up in programme design and allocating time and resources; building implementer capacity to catalyse scale-up; adopting effective approaches to advocacy; presenting strong evidence to support government decision making; involving government in programme design; invoking policy champions and networks; strengthening harmonisation among external programmes; aligning innovations with health systems and priorities. Other steps include: supporting government to develop policies and programmes and strengthening health systems and staff; promoting community uptake by involving media, community leaders, mobilisation teams and role models. We conclude that scale-up has no magic bullet solution - implementers must embrace multiple activities, and require substantial support from donors and governments in doing so.

Basic or enhanced clinician training to improve adherence to malaria treatment guidelines: a cluster-randomised trial in two areas of Cameroon.

BACKGROUND: The scale-up of malaria rapid diagnostic tests (RDTs) is intended to improve case management of fever and targeting of artemisinin-based combination therapy. Habitual presumptive treatment has hampered these intentions, suggesting a need for strategies to support behaviour change. We aimed to assess the introduction of RDTs when packaged with basic or enhanced clinician training interventions in Cameroon. METHODS: We did a three-arm, stratified, cluster-randomised trial at 46 public and mission health facilities at two study sites in Cameroon to compare three approaches to malaria diagnosis. Facilities were randomly assigned by a computer program in a 9:19:19 ratio to current practice with microscopy (widely available, used as a control group); RDTs with a basic (1 day) clinician training intervention; or RDTs with an enhanced (3 days) clinician training intervention. Patients (or their carers) and fieldworkers who administered surveys to obtain outcome data were masked to study group assignment. The primary outcome was the proportion of patients treated in accordance with WHO malaria treatment guidelines, which is a composite indicator of whether patients were tested for malaria and given appropriate treatment consistent with the test result. All analyses were by intention to treat. This study is registered at ClinicalTrials.gov, number NCT01350752. FINDINGS: The study took place between June 7 and Dec 14, 2011. The analysis included 681 patients from nine facilities in the control group, 1632 patients from 18 facilities in the basic-training group, and 1669 from 19 facilities in the enhanced-training group. The proportion of patients treated in accordance with malaria guidelines did not improve with either intervention; the adjusted risk ratio (RR) for basic training compared with control was 1·04 (95% CI 0·53-2·07; p=0·90), and for enhanced training compared with control was 1·17 (0·61-2·25; p=0·62). Inappropriate use of antimalarial drugs after a negative test was reduced from 84% (201/239) in the control group to 52% (413/796) in the basic-training group (unadjusted RR 0·63, 0·28-1·43; p=0·25) and to 31% (232/759) in the enhanced-training group (0·29, 0·11-0·77; p=0·02). INTERPRETATION: Enhanced clinician training, designed to translate knowledge into prescribing practice and improve quality of care, has the potential to halve overtreatment in public and mission health facilities in Cameroon. Basic training is unlikely to be sufficient to support the behaviour change required for the introduction of RDTs.

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

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