Complex Health System Intervention Research Articles

Using routine data for long term impact evaluation: Methodological reflections from a complex health system intervention in a low-income context

Using routine data for long term impact evaluation: Methodological reflections from a complex health system intervention in a low-income context

Improving systems of prenatal and postpartum care for hyperglycemia in pregnancy: A process evaluation

To identify successes to date and opportunities for improvement in the implementation of a complex health systems intervention aiming to improve prenatal and postpartum care and health outcomes for women with hyperglycemia in pregnancy in regional and remote Australia. A qualitative evaluation, underpinned by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance), was conducted mid-intervention. Semi-structured interviews were conducted with the participants, who included clinicians, regional policymakers and managers, and study implementation staff. Interviewees (n=45) reported that the early phase of the intervention had resulted in the establishment of a clinician network, increased clinician awareness of hyperglycemia in pregnancy, and improvements in management, including earlier referral for specialist care and a focus on improving communication with women. Enablers of implementation included existing relationships with stakeholders and alignment of the intervention with health service priorities. Challenges included engaging remote clinicians and the labor-intensive nature of maintaining a clinical register of women with hyperglycemia in pregnancy. The early phase of this health systems intervention has had a positive perceived impact on systems of care for women with hyperglycemia in pregnancy. Findings have informed modifications to the intervention, including the development of a communication and engagement strategy.

Looking into the performance-based financing black box: evidence from an impact evaluation in the health sector in Cameroon.

Performance-based financing (PBF) is a complex health systems intervention aimed at improving the coverage and quality of care. Several studies have shown a positive impact of PBF on health service coverage, often coupled with improvements in quality, but relatively little is known about the mechanisms driving those results. This article presents results of a randomized impact evaluation in Cameroon designed to isolate the role of specific components of the PBF approach with four study groups: (i) PBF with explicit financial incentives linked to results, (ii) direct financing with additional resources available for health providers not linked to performance, (iii) enhanced supervision and monitoring without additional resources and (iv) a control group. Overall, results indicate that, when compared with the pure control group, PBF in Cameroon led to significant increases in utilization for several services (child and maternal vaccinations, use of modern family planning), but not for others like antenatal care visits and facility-based deliveries. In terms of quality, PBF increased the availability of inputs and equipment, qualified health workers, led to a reduction in formal and informal user fees but did not affect the content of care. However, for many positively impacted outcomes, the differences between the PBF group and the group receiving additional financing not linked to performance are not significant, suggesting that additional funding rather than the explicit incentives might be driving improvements. In contrast, the intervention group offering enhanced supervision, coaching and monitoring without additional funding did not experience significant impacts compared to the control group.

Implementation research and human-centred design: how theory driven human-centred design can sustain trust in complex health systems, support measurement and drive sustained community health volunteer engagement.

Human-centred design (HCD) can support complex health system interventions by navigating thorny implementation problems that often derail population health efforts. HCD is a pragmatic, ‘practice framework’, not an intervention protocol. It can build empathy by bringing patient voice, user perspective and innovation to construct and repair pieces of the intervention or health system. However, its emphasis on product development and process change with fixed end points has left it as an approach lacking explanatory power and reproducible measurement. Yet when informed by theory, the tremendous innovation potential of HCD can be harnessed to drive sustainability, mediate implementation problems, frame measurement constructs and ultimately improve population-level health outcomes. In attempting to mine, the potential of HCD we move beyond the pragmatic ‘how it works’, to the theoretical question, ‘why it works’. In doing so, we explore a more fundamental human question, ‘How can participation and engagement be sustained for impact in close to the community health systems?’ In this exploration, we illustrate the power of HCD by linking it to our theory of trust building. The research method we utilize is that of a longitudinal process evaluation. We leverage the heterogeneity of five community health units from the diverse setting (rural, peri-urban slum) to better understand what works for whom and in what context by tracking 21 groups of community health volunteers (CHVs) over 12 months. We report results with a focus on the outlier case failure to illustrate the contrast with common features of sustained CHV engagement, where recurrent reciprocal cycles of trust building are demonstrated in the successful implementation of action plans in plan-do-study-act cycles for improvement. All was accomplished by CHVs with no external funding. We conclude by discussing how HCD could be unleashed if linked to theoretical frameworks, increasing ability to address implementation challenges in complex health systems.

Improving systems of care during and after a pregnancy complicated by hyperglycaemia: A protocol for a complex health systems intervention

BackgroundMany women with hyperglycaemia in pregnancy do not receive care during and after pregnancy according to standards recommended in international guidelines. The burden of hyperglycaemia in pregnancy falls disproportionately upon Indigenous peoples worldwide, including Aboriginal and Torres Strait Islander women in Australia. The remote and regional Australian context poses additional barriers to delivering healthcare, including high staff turnover and a socially disadvantaged population with a high prevalence of diabetes.MethodsA complex health systems intervention to improve care for women during and after a pregnancy complicated by hyperglycaemia will be implemented in remote and regional Australia (the Northern Territory and Far North Queensland). The Theoretical Domains Framework was used during formative work with stakeholders to identify intervention components: (1) increasing workforce capacity, skills and knowledge and improving health literacy of health professionals and women; (2) improving access to healthcare through culturally and clinically appropriate pathways; (3) improving information management and communication; (4) enhancing policies and guidelines; (5) embedding use of a clinical register as a quality improvement tool. The intervention will be evaluated utilising the RE-AIM framework at two timepoints: firstly, a qualitative interim evaluation involving interviews with stakeholders (health professionals, champions and project implementers); and subsequently a mixed-methods final evaluation of outcomes and processes: interviews with stakeholders; survey of health professionals; an audit of electronic health records and clinical register; and a review of operational documents. Outcome measures include changes between pre- and post-intervention in: proportion of high risk women receiving recommended glucose screening in early pregnancy; diabetes-related birth outcomes; proportion of women receiving recommended postpartum care including glucose testing; health practitioner confidence in providing care, knowledge and use of relevant guidelines and referral pathways, and perception of care coordination and communication systems; changes to health systems including referral pathways and clinical guidelines.DiscussionThis study will provide insights into the impact of health systems changes in improving care for women with hyperglycaemia during and after pregnancy in a challenging setting. It will also provide detailed information on process measures in the implementation of such health system changes.

SEEP-CI: A Structured Economic Evaluation Process for Complex Health System Interventions.

The economic evaluation of health system interventions is challenging, and methods guidance on how to respond to these challenges is lacking. The REACHOUT consortium developed and evaluated complex interventions for community health program quality improvement in six countries in Africa and Asia. Reflecting on the challenges we faced in conducting an economic evaluation alongside REACHOUT, we developed a Structured Economic Evaluation Process for Complex Health System Interventions (SEEP-CI). The SEEP-CI aims to establish the threshold effect size that would justify investment in a complex intervention, and provide an assessment to a decision-maker of how likely it is that the intervention can achieve this impact. We illustrate how the SEEP-CI could have been applied to REACHOUT to identify outcomes where the intervention might have impact and causal mechanisms, through which that impact might occur, guide data collection by focusing on proximal outcomes most likely to illustrate the effectiveness of the intervention, identify the size of health gain required to justify investment in the intervention, and indicate the assumptions required to accept that such health gains are credible. Further research is required to determine the feasibility and acceptability of the SEEP-CI, and the contexts in which it could be used.

Development and Implementation of a Complex Health System Intervention Targeting Transitions of Care from Hospital to Post-acute Care.

Failure of effective transitions of care following hospitalization can lead to excess days in the hospital, readmissions, and adverse events. Evidence identifies both patient and system factors that influence poor care transitions, yet health systems struggle to translate evidence into complex interventions that have a meaningful impact on care transitions. We report on our experience developing, pilot testing, and evaluating a complex intervention (Addressing Complex Transitions program, or ACT program) that aims to improve care transitions for complex patients. Following the Medical Research Council (MRC) framework, we engaged in iterative, stakeholder-driven work to develop a complex care intervention, assess feasibility and pilot methods, evaluate the intervention in practice, and facilitate ongoing implementation monitoring and dissemination. Patients receiving care from UW Medicine's health system including 4 hospitals and 20-site Post-Acute Care network. Literature review and prospective data collection activities informed ACT program design. ACT program components include a tailored risk calculator that provides real-time scoring of transitions of care risk factors, a multidisciplinary team with the capacity to address complex barriers to safe transitions, and enhanced discharge workflows to improve care transitions for complex patients. Program evaluation metrics included estimated hospital days saved and program acceptance by care team members. During the 6-month pilot, 565 patients were screened and 97 enrolled in the ACT program. An estimated 664 hospital days were saved for the index admission of ACT program participants. Analysis of pre/post-hospital utilization for ACT program participants showed an estimated 3227 fewer hospital days after ACT program enrollment. Health systems need to address increasingly difficult challenges in care delivery. The use of evidence-based frameworks, such as the MRC framework, can guide systems to design complex interventions that respond to their local context and stakeholder needs.

Exploiting the emergent nature of mixed methods designs: insights from a mixed methods impact evaluation in Malawi

The application of mixed methods in Health Policy and Systems Research (HPSR) has expanded remarkably. Nevertheless, a recent review has highlighted how many mixed methods studies do not conceptualize the quantitative and the qualitative component as part of a single research effort, failing to make use of integrated approaches to data collection and analysis. More specifically, current mixed methods studies rarely rely on emergent designs as a specific feature of this methodological approach. In our work, we postulate that explicitly acknowledging the emergent nature of mixed methods research by building on a continuous exchange between quantitative and qualitative strains of data collection and analysis leads to a richer and more informative application in the field of HPSR. We illustrate our point by reflecting on our own experience conducting the mixed methods impact evaluation of a complex health system intervention in Malawi, the Results Based Financing for Maternal and Newborn Health Initiative. We describe how in the light of a contradiction between the initial set of quantitative and qualitative findings, we modified our design multiple times to include additional sources of quantitative and qualitative data and analytical approaches. To find an answer to the initial riddle, we made use of household survey data, routine health facility data, and multiple rounds of interviews with both healthcare workers and service users. We highlight what contextual factors made it possible for us to maintain the high level of methodological flexibility that ultimately allowed us to solve the riddle. This process of constant reiteration between quantitative and qualitative data allowed us to provide policymakers with a more credible and comprehensive picture of what dynamics the intervention had triggered and with what effects, in a way that we would have never been able to do had we kept faithful to our original mixed methods design.

Improving Models of Care for Diabetes in Pregnancy: Experience of Current Practice in Far North Queensland, Australia.

Aims: To map health practitioners' experiences and describe knowledge regarding screening and management of Diabetes in Pregnancy (DIP) in Far North Queensland, Australia.Methods: Mixed methods including a cross-sectional survey (101 respondents) and 8 focus groups with 61 health practitioners. All participants provided clinical care for women with DIP.Results: A wide range of healthcare professionals participated; 96% worked with Indigenous women, and 63% were from regional or remote work settings. Universal screening for gestational diabetes at 24–28 weeks gestation was reported as routine with 87% using a 75 g Oral Glucose Tolerance Test. Early screening for DIP was reported by 61% although there was large variation in screening methods and who should be screened <24 weeks. Health practitioners were confident providing lifestyle advice (88%), dietary, and blood glucose monitoring education (67%, 81%) but only 50% were confident giving insulin education. Electronic medical records were used by 80% but 55% also used paper records. Dissatisfaction with information from hospitals was reported by 40%. In the focus groups improving communication and information technology systems were identified as key areas. Other barriers described were difficulties in care coordination and access for remote women.Conclusions: Communication, information technology systems, coordination of care, and education for health professionals are key areas that will be addressed by a complex health systems intervention being undertaken by the DIP Partnership in North Queensland.

Crossing borders: the PACK experience of spreading a complex health system intervention across low-income and middle-income countries

Developing a health system intervention that helps to improve primary care in a low-income and middle-income country (LMIC) is a considerable challenge; finding ways to spread that intervention to other...

216. Evaluation of the PIERS on the MOVE mobile health tool for pre-eclampsia triage: The users’ perspective

Background The PIERS on the Move (POM) mobile health (mHealth) application was implemented as part of a complex community health system intervention in the CLIP (Community Level Interventions for Pre-eclampsia; NCT01911494) Trials. In this context, community health workers (CHWs) were trained to use the app and to take on new clinical skills, such as measuring blood pressure and assessing symptoms. Objective To evaluate the perceived impact on pre-eclampsia knowledge, self-efficacy and CHW role from use of the POM app. Method This study used mixed methods including closed and open-ended survey questions and focus group discussions (FGDs) based on the SALT (Stimulate, Appreciate, Learn, Transfer) approach. All health care workers who participated in the CLIP Trials in Pakistan and India were eligible to participate. A random sample, stratified by age and years of experience, was drawn to target participants for qualitative evaluation after completion of recruitmentfor the Trials. Survey results were summarized and qualitative data analyzed using grounded theory. Results In India, 24 CHWs completed the survey and were interviewed. In Pakistan, 219 CHWs completed the survey and 18 participated in 3 follow-up FGDs. CHWs in both countries reported a high level of pre-eclampsia knowledge and self-efficacy. Qualitative data analyzed from the interviews in India and FGDs in Pakistan indicate a high level of job satisfaction with themes emerging related to positive ability to manage pregnancy complications; happiness with supporting healthy pregnancy and birth and satisfaction with new knowledge and responsibilities. Challenges reported included initial difficulties learning to use a smart phone and technical issues with the device itself (battery life and screen size). Conclusions This study supports the ability and desire of community health workers to use mobile health tools such as the PIERS on the Move app to support their performance of clinical tasks related to pre-eclampsia care.

218. Implementation of the PIERS on the Move mobile health app in the Community Level Interventions for Pre-eclampsia trials

Background The PIERS on the Move (POM) app was implemented as part of a complex health system intervention in the CLIP (Community Level Interventions for Pre-eclampsia; NCT01911494) Trials in India, Pakistan and Mozambique. POM guides community health workers through an antenatal/postnatal assessment and provides recommendations for referral to a nearby facility with immediate treatment with MgSO4 and methyldopa when hypertension is detected, based on disease severity. Objective To evaluate the implementation of the POM app based on population coverage, compliance and recommendation acceptance. Methods As per the protocol, coverage was measured as the proportion of women receiving one or more POM home visit out of all pregnancies registered in the intervention area and compliance was measured as the proportion of women receiving the minimum standard of monthly POM home visits. Acceptance of recommendation and was summarized and rates of outcome for women in intervention areas with and without a recommendation presented. Results In total 21,416/36,077 eligible women received 151,893 POM visits (76.2% antepartum, 23.8% postpartum) during the CLIP Trials. Coverage was 90.0% in India, 56.6% in Pakistan and 61.2% in Mozambique. Compliance rates were 55.4% in India; 63.4% in Pakistan; and 77.0% in Mozambique. Rate of triage recommendation was 5.6% (1194/21,416) of the covered population in total. The primary reason for referral was non-severe hypertension. Women’s acceptance of recommendations was 77.0% overall. In intervention clusters, the rate of adverse maternal outcomes in women who received recommendations compared to those who did not was higher in India (11.7% vs 4.3%) and Mozambique (11.3% vs. 7.7%) but similar in Pakistan (5.0% vs. 5.0%). Conclusion During the CLIP Trials there was good coverage and compliance and a high rate of community acceptance of triage recommendations after implementation of the POM app but limited apparent impact on maternal health outcomes.

'The money can be a motivator, to me a little, but mostly PBF just helps me to do better in my job.' An exploration of the motivational mechanisms of performance-based financing for health workers in Malawi.

Performance-based financing (PBF) is assumed to improve health care delivery by motivating health workers to enhance their work performance. However, the exact motivational mechanisms through which PBF is assumed to produce such changes are poorly understood to date. Although PBF is increasingly recognized as a complex health systems intervention, its motivational effect for individual health workers is still often reduced to financial 'carrots and sticks' in the literature and discourse. Aiming to contribute to the development of a more comprehensive understanding of the motivational mechanisms, we explored how PBF impacted health worker motivation in the context of the Malawian Results-based Financing for Maternal and Newborn Health (RBF4MNH) Initiative. We conducted in-depth interviews with 41 nurses, medical assistants and clinical officers from primary- and secondary-level health facilities 1 and 2years after the introduction of RBF4MNH in 2013. Six categories of motivational mechanisms emerged: RBF4MNH motivated health workers to improve their performance (1) by acting as a periodic wake-up call to deficiencies in their day-to-day practice; (2) by providing direction and goals to work towards; (3) by strengthening perceived ability to perform successfully at work and triggering a sense of accomplishment; (4) by instilling feelings of recognition; (5) by altering social dynamics, improving team work towards a common goal, but also introducing social pressure; and (6) by offering a 'nice to have' opportunity to earn extra income. However, respondents also perceived weaknesses of the intervention design, implementation-related challenges and contextual constraints that kept RBF4MNH from developing its full motivating potential. Our results underline PBF's potential to affect health workers' motivation in ways which go far beyond the direct effects of financial rewards to individuals. We strongly recommend considering all motivational mechanisms more explicitly in future PBF design to fully exploit the approach's capacity for enhancing health worker performance.

Challenges for gatekeeping: a qualitative systems analysis of a pilot in rural China

BackgroundGatekeeping involves a generalist doctor who controls patients’ access to specialist care, and has been discussed as an important policy option to rebalance the primary care and hospital sectors in low- and middle-income countries, despite thin evidence. A gatekeeping pilot in a Chinese rural setting launched in 2013 has offered an opportunity to study the functioning of gatekeeping under such conditions.MethodsIn this qualitative study within a mixed-method evaluation of the gatekeeping pilot, we developed an innovative systems analysis method, combining the World Health Organisation categorisation of health system building blocks, the “Framework” approach of policy analysis and causal loop analysis. We conducted in-depth interviews with 20 stakeholders from 4 groups (patients, doctors, health facility managers and government administrators) in the pilot area over two years. Based on information extracted from the interviews, we drew a causal loop diagram which highlighted the feedback loops within the system that had self-reinforcing or self-balancing characteristics, and used the diagram to examine systematically the mechanisms of intended and actual functioning of gatekeeping and analyse the systems level challenges that affected the effectiveness of gatekeeping.ResultsHad the gatekeeping pilot programme worked as intended, it would incentivize both providers and patients to increase service utilization at primary care level, as well as establish and enhance two reinforcing feedback loops to shift balance towards primary care. However, a performance-based salary policy undermined the motivation for clinical primary care. Furthermore, the primary care providers suffered from three reinforcing feedback loops (related to primary care capacity, human resource sustainability, patients’ faith) that trapped primary care development in vicious cycles. At the interface between hospitals and primary care providers, there were also feedback loops exacerbating the existing hospital dominance. These feedback loops were intensified by the unintended consequences of concurrent policies (restrictions on technologies and medicines) and delayed reform in hospitals. Furthermore, the gatekeeping policy itself faced resistance to further development, due to the prevailing ineffective and ritualistic nature of gatekeeping, which formed a balancing loop.ConclusionsThe study shows that the intended benefits of gatekeeping were illusionary largely due to weak and worsening primary care conditions, and delay, ineffectiveness or unintended consequences of several other ongoing reforms. One particularly dangerous development of the system, which deserves urgent attention, is the harming of the professional prospects of primary care doctors. Our findings highlight the need for coordination and prioritization in designing policies related to primary care and managing changes with multiple on-going reforms. The approach used here facilitates comprehensive study of intended and actual mechanisms, and demonstrates the challenges of a complex health system intervention in a dynamic environment.

For Super-Utilizers, Integrated Care Offers A New Path.

Many health systems continue to experiment with the best way to care for those patients who end up in the hospital most frequently.

Expanding the evidence base for global recommendations on health systems: strengths and challenges of the OptimizeMNH guidance process.

BackgroundIn 2012, the World Health Organization (WHO) published recommendations on the use of optimization or “task-shifting” strategies for key, effective maternal and newborn interventions (the OptimizeMNH guidance). When making recommendations about complex health system interventions such as task-shifting, information about the feasibility and acceptability of interventions can be as important as information about their effectiveness. However, these issues are usually not addressed with the same rigour. This paper describes our use of several innovative strategies to broaden the range of evidence used to develop the OptimizeMNH guidance. In this guidance, we systematically included evidence regarding the acceptability and feasibility of relevant task-shifting interventions, primarily using qualitative evidence syntheses and multi-country case study syntheses; we used an approach to assess confidence in findings from qualitative evidence syntheses (the Grading of Recommendations, Assessment, Development and Evaluation-Confidence in Evidence from Reviews of Qualitative Research (GRADE-CERQual) approach); we used a structured evidence-to-decision framework for health systems (the DECIDE framework) to help the guidance panel members move from the different types of evidence to recommendations.ResultsThe systematic inclusion of a broader range of evidence, and the use of new guideline development tools, had a number of impacts. Firstly, this broader range of evidence provided relevant information about the feasibility and acceptability of interventions considered in the guidance as well as information about key implementation considerations. However, inclusion of this evidence required more time, resources and skills. Secondly, the GRADE-CERQual approach provided a method for indicating to panel members how much confidence they should place in the findings from the qualitative evidence syntheses and so helped panel members to use this qualitative evidence appropriately. Thirdly, the DECIDE framework gave us a structured format in which we could present a large and complex body of evidence to panel members and end users. The framework also prompted the panel to justify their recommendations, giving end users a record of how these decisions were made.ConclusionsBy expanding the range of evidence assessed in a guideline process, we increase the amount of time and resources required. Nevertheless, the WHO has assessed the outputs of this process to be valuable and is currently repeating the approach used in OptimizeMNH in other guidance processes.

Study protocol: realist evaluation of effectiveness and sustainability of a community health workers programme in improving maternal and child health in Nigeria.

BackgroundAchievement of improved maternal and child health (MCH) outcomes continues to be an issue of international priority, particularly for sub-Saharan African countries such as Nigeria. Evidence suggests that the use of Community Health Workers (CHWs) can be effective in broadening access to, and coverage of, health services and improving MCH outcomes in such countries.Methods/designIn this paper, we report the methodology for a 5-year study which aims to evaluate the context, processes, outcomes and longer-term sustainability of a Nigerian CHW scheme. Evaluation of complex interventions requires a comprehensive understanding of intervention context, mechanisms and outcomes. The multidisciplinary and mixed-method realist approach will facilitate such evaluation. A favourable policy environment within which the study is conducted will ensure the successful uptake of results into policy and practice.A realist evaluation provides an overall methodological framework for this multidisciplinary and mixed methods research, which will be undertaken in Anambra state. The study will draw upon health economics, social sciences and statistics. The study comprises three steps: (1) initial theory development; (2) theory validation and (3) theory refinement and development of lessons learned. Specific methods for data collection will include in-depth interviews and focus group discussions with purposefully identified key stakeholders (managers, service providers and service users), document reviews, analyses of quantitative data from the CHW programme and health information system, and a small-scale survey. The impact of the programme on key output and outcome indicators will be assessed through an interrupted time-series analysis (ITS) of monthly quantitative data from health information system and programme reports. Ethics approvals for this study were obtained from the University of Leeds and the University of Nigeria.DiscussionThis study will provide a timely and important contribution to health systems strengthening specifically within Anambra state in southeast Nigeria but also more widely across Nigeria. This paper should be of interest to researchers who are interested in adapting and applying robust methodologies for assessing complex health system interventions. The paper will also be useful to policymakers and practitioners who are interested in commissioning and engaging in such complex evaluations to inform policies and practices.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-016-0443-1) contains supplementary material, which is available to authorized users.

Application of systems thinking: 12-month postintervention evaluation of a complex health system intervention in Zambia: the case of the BHOMA.

Strong health systems are said to be paramount to achieving effective and equitable health care. The World Health Organization has been advocating for using system-wide approaches such as 'systems thinking' to guide intervention design and evaluation. In this paper we report the system-wide effects of a complex health system intervention in Zambia known as Better Health Outcome through Mentorship and Assessment (BHOMA) that aimed to improve service quality. We conducted a qualitative study in three target districts. We used a systems thinking conceptual framework to guide the analysis focusing on intended and unintended consequences of the intervention. NVivo version 10 was used for data analysis. The addressed community responded positively to the BHOMA intervention. The indications were that in the short term there was increased demand for services but the health worker capacity was not severely affected. This means that the prediction that service demand would increase with implementation of BHOMA was correct and the workload also increased, but the help of clinic lay supporters meant that some of the work of clinicians was transferred to these lay workers. However, from a systems perspective, unintended consequences also occurred during the implementation of the BHOMA. We applied an innovative approach to evaluate a complex intervention in low-income settings, exploring empirically how systems thinking can be applied in the context of health system strengthening. Although the intervention had some positive outcomes by employing system-wide approaches, we also noted unintended consequences.

A cluster randomised trial to evaluate the effect of optimising TB/HIV integration on patient level outcomes: The “merge” trial protocol

IntroductionWe describe the design of the MERGE trial, a cluster randomised trial, to evaluate the effect of an intervention to optimise TB/HIV service integration on mortality, morbidity and retention in care among newly-diagnosed HIV-positive patients and newly-diagnosed TB patients. DesignEighteen primary care clinics were randomised to either intervention or standard of care arms. The intervention comprised activities designed to optimise TB and HIV service integration and supported by two new staff cadres—a TB/HIV integration officer and a TB screening officer—for 24months. A process evaluation to understand how the intervention was perceived and implemented at the clinics was conducted as part of the trial. Newly-diagnosed HIV-positive patients and newly-diagnosed TB patients were enrolled into the study and followed up through telephonic interviews and case note abstractions at six monthly intervals for up to 18months in order to measure outcomes. The primary outcomes were incidence of hospitalisations or death among newly diagnosed TB patients, incidence of hospitalisation or death among newly diagnosed HIV-positive patients and retention in care among HIV-positive TB patients. Secondary outcomes of the study included measures of cost-effectiveness. DiscussionMethodological challenges of the trial such as implementation of a complex multi-faceted health systems intervention, the measurement of integration at baseline and at the end of the study and an evolving standard of care with respect to TB and HIV are discussed. The trial will contribute to understanding whether TB/HIV service integration affects patient outcomes.

Application of system thinking concepts in health system strengthening in low-income settings: a proposed conceptual framework for the evaluation of a complex health system intervention: the case of the BHOMA intervention in Zambia.

The current drive to strengthen health systems provides an opportunity to develop new strategies that will enable countries to achieve targets for millennium development goals. In this paper, we present a proposed framework for evaluating a new health system strengthening intervention in Zambia known as Better Health Outcomes through Mentoring and Assessment. We briefly describe the intervention design and focus on the proposed evaluation approach through the lens of systems thinking. In this paper, we present a proposed framework to evaluate a complex health system intervention applying systems thinking concepts. We hope that lessons learnt from this process will help to adapt the intervention and limit unintended negative consequences while promoting positive effects. Emphasis will be paid to interaction and interdependence between health system building blocks, context and the community.