Uzochukwu B, Obikeze E, Onwujekwe O, Onoka C, Griffiths U. 2001;6(2):123–6. [PMC free article] Marchal B, Van Belle SB, Van Olmen J, Hoeree T, Kegels G. Is realist evaluation keeping its promise_ A review of published empirical studies in the field of health systems research. The datasets will consist of indicator panels comprising health facilities within the three clusters in Anambra state where the two variations of the intervention are occurring (SURE-P/MCH and SURE-P/MCH + CCT, respectively), as well as a cluster where neither variation is implemented, which will function as a control. Wolff N. Randomised trials of socially complex interventions: promise or peril? The project workplan showing overlaps between the three steps is included in Additional file 2. The LM for SURE-P/MCH was developed using a combination of documents review, informal consultations with SURE-P/MCH manager and a technical workshop that involved researchers from the Universities of Leeds and Nigeria. t First, small-scale facility exit survey (about 300 respondents) will use structured questionnaire to explore user perceptions about the programme and their experiences in accessing MCH care. This includes ensuring regular communication between the partners and engagement with policymakers and practitioners; quality assurance through regular peer-review within and between the teams; appropriate mentoring and coaching support to more junior researchers and equal opportunities to both genders. The specific objectives of the study are to: Develop an in-depth understanding of the context and the process of implementation of the interventions, including relationships between health workforce and infrastructure and supplies, Identify, assess and compare the intervention outputs (e.g. alternative respondents). is an error term. Correspondence to COMDIS-HSD. Ethics approvals for this study were obtained from the University of Leeds and the University of Nigeria. Developing and Evaluating Complex Interventions. Maluka S, Kamuzora P, SanSebastian M, Byskov J, Ndawi B, Olsen O, et al. The NDP comprises a range of organisational and service delivery changes to support evidence-based practices and policies. London: SAGE Publications; 1997. with and without CCTs) of a Nigerian CHW programme to understand what contextual factors promote equitable access to quality services and examining the conditions under which these changes can be sustained following withdrawal of funding. The study comprises three steps: (1) initial theory development; (2) theory validation and (3) theory refinement and development of lessons learned. The Health Policy Research Group, University of Nigeria has developed three models for getting research into policy and practice (GRIPP), which will also be applied in this study. Evaluation of complex interventions requires a comprehensive understanding of intervention context, mechanisms and outcomes. The realist evaluation approach is a relatively new approach to evaluation, especially in some fields (such as health services research). 2010;25(5):551–64. An example involving the first two indicators might be: ‘deployment of CHWs, combined with improvement in infrastructure and supplies when implemented within the health systems context of Nigeria, will help reduce maternal and neonatal mortalities to 320/100,000 and 7/1000 live births respectively’. Specific emphasis will be placed on confidentiality and other data protection issues, which will include security of data storage and access rights to data. is a time series trend variable; I The project will be carried out with full respect of current relevant legislation (e.g. The data will be collected using three methods. Hudson J, Lowe S. Understanding the Policy Process: Analysing Welfare Policy and Practice. In October 2015, 6 months after being elected, the new President of Nigeria announced his decision to reverse fuel subsidy reduction in order to catalyse the economic growth, effectively withdrawing government funding to SURE-P. The qualitative evaluation proposed will be based on the document analysis of yearly ICP progress reports, selected case studies and focus group interviews with stakeholders. Bull World Health Organ. Geneva: World Health Organization; 2012. We recognise context as a key influence in achieving the intended results. This paper should be of interest to researchers who are interested in adapting and applying robust methodologies for assessing complex health system interventions. PubMed  Cookies policy. The protocol is largely very clear and well described but there are some areas that require further elaboration: While the aims and objectives have a realist flavor to them, the research questions seem to … The specific hypotheses will be driven by the study research questions (see Table 1) and will relate to the key programme targets ([40] p. 17), Reduction of MMR by 59 % from 545/100,000 live births to 320/100,000 live births, Reduction of neonatal mortality rate by 22 % from 37/1000 live births to 29/1000 live births, Increased percentage of pregnant women receiving focused antenatal care (ANC) by 52% from 50 % coverage, Increased percentage of skilled birth attendance by 63 % (from 16 % baseline), Increased postnatal care attendance within 2 days of birth by 63 % (from 16 % baseline), Increased family planning attendance by 26 % (from 1 % baseline). London: Sage Publications Limited; 1997. The impact of the programme on a range of key output and outcome indicators will be assessed through an interrupted time-series analysis (ITS) of monthly (the unit of analysis) quantitative data from HMIS and SURE-P M&E monthly programme reports. Article  Helsinki Declaration). Leeds, U.K: COMDIS-Health Service Delivery; 2012. The project will be implemented according to standard governance practices at the University of Leeds and University of Nigeria. First, the policy environment in Nigeria within which the research is being undertaken is favourable to ensure a high-quality analysis, inform theoretical debate and ensure the uptake of results into policy and practice, as we found within our previous collaborative projects. Our study should improve understanding of the performance and functioning of complex system interventions involving both supply and demand sides. UNICEF, WHO. Study protocol: realist evaluation of effectiveness and sustainability of a community health workers programme in improving maternal and child health in Nigeria. The parameter β0 represents the baseline level of the dependent variable; β1 represents the baseline trend in the dependent variable; β2 isolates any shift in the level (intercept) of the dependent variable following the introduction of the policy; β3 isolates any shift in the rate of change (slope) following the introduction of the policy and β4 represents the effect of a covariate. Geneva: WHO; 2007. Fiona Keogh, Maria Pierce, Karen Neylon, Padraic Fleming, Intensive home care packages for people with dementia: a realist evaluation protocol, BMC Health Services Research, 10.1186/s12913-018-3630-8, 18, 1, (2018). It describes five key ideas which frame realism and their implications for impact evaluation. equitable access to quality MCH services and attainment of MCH outcome targets) during and after withdrawal of targeted support to the programme, Develop an empirically based and theoretically grounded dynamic model of complex relations between the actors, context, implementation process, outputs and outcomes of the interventions during, and after withdrawal, of targeted support to the programme, Assess the role of different advocacy and lobbying efforts in entrenching MCH on the political agenda and strengthening the provision of MCH services, following the suspension of targeted support to SURE-P/MCH, Develop transferable best practices for scalability (expansion within a broadly similar context) and generalisability (expansion to different contexts) of the lessons learned. alternative respondents). Bull World Health Organ. Countdown to 2015. Health Policy Plan. For further reference on the realist interview and realist data collection, Manzano’s (2016) paper provides an overview of interviewing within a realist evaluation. Lehmann U, Sanders D. Community health workers: What do we know about them? 2008;86:452–9. We realise, however, that implementation of a new programme can have an impact that goes beyond the direct programme beneficiaries and will consider these effects qualitatively through conducting IDIs with key actors referred to earlier. 1, the mixed methods approach will enable us to also analyse the intervention implementation outcomes, e.g. These costs represent opportunity costs of the programme that contribute to the overall cost that may vary across contexts. Abuja, Nigeria: Subsidy Reinvestment and Empowerment Programme (SURE-P); 2013. A detailed list of respondents will be developed within step 1, and snowballing will be used to identify any further informants. autocorrelation), and important covariates will also be adjusted for, while multilevel methods will be used to address variation across health facilities. It is important to stress that realist evaluation cannot be achieved simply by following a protocol in a technically correct manner. The authors declare that they have no competing interests. More accessible midwives/CHWs, for example, may reduce the cost to households of obtaining care. Leeds, UK: University of Leeds; 2015. Gopalan SS, Mutasa R, Friedman J, Das A. These are available in Additional files 3 and 4, respectively. (ZIP 1568 kb), Pre-implementation Logic Map for SURE-P/MCH. is time after the intervention; X Options discussed included stopping or amending the research, as well as technical and political implications of each option from the different (policymakers’ and the funder’s) perspectives. realist evaluation covering the same kind of project or programme. For example, at the output level, we might expect that facility delivery rates will increase: the quantitative analysis will quantify the rate of change; the reasons for the change at this rate will then be explored using qualitative methods. 1) provides an overarching hypothesis, and more specific hypothetical pathways will represent the middle-range theories (MRT) to help us explore the C-M-O configurations within the programme. Gilmore B, McAuliffe E. Effectiveness of community health workers delivering preventive interventions for maternal and child health in low- and middle-income countries: a systematic review. 2010;88:364–70. Pawson and Tilley (1997) developed the first realist evaluation approach, although other interpretations have been developed since. We will use social science methods to explore views of key actor groups. Google Scholar. it is a form of primary research. Whereas in realist review the primary data comes from documents (e.g. The use of CHWs was promoted in an attempt to implement interventions using lower cadres of workers to accelerate achievement of universal healthcare coverage [7–10]. Evaluation. Onwujekwe O, Dike N, Ojukwu J, Uzochukwu B, Ezumah N, Shu E, et al. The realist evaluation approach is a relatively new approach to evaluation, especially in some fields (such as health services research). Subsidy Reinvestment and Empowerment Programme (SURE-P): 2012 Annual Report. The challenge posed by dementia, which is the confluence of increasing life expectancy, population growth and the lack of cura-tive treatments, has been well documented [42, 54]. CHW programmes are inherently complex, and their success is mediated by how the intervention is implemented within the health system context. financial incentives to pregnant women to register at a Primary Health Care (PHC) centre, receive health check-ups while pregnant, deliver at a health facility and take their baby for vaccinations. Achievement 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. We will explore context at the macro level (e.g. 2004;10(1):58–76. In Nigeria, for example, despite the significant reduction in maternal and neonatal mortality since 2003 by 50 and 23 %, respectively, these still remain high at 545/100,000 and 37/1000 births, respectively, particularly in rural areas where most vulnerable groups reside [2, 3]. BMJ Open 2012, 2(5). Methodology and analysis This paper disseminates the protocol for an 18-month ‘RESPOND’ project that aims to evaluate the system of collecting and responding to user feedback in Bangladesh. We will explore views of MCH service users on SURE-P, its costs and effects. Article  The purpose of this paper is to share the study protocol for realist evaluation of CHW programme in Nigeria. (PDF 555 kb), Ethical approvals from the University of Nigeria. I The respondents for IDIs, identified through purposive sampling, will include health facility managers, CHWs, PHC staff and health planners and programme managers at local, state and federal levels. In this paper, we report a protocol for realist evaluation study of DeteRminants of Effectiveness and sustainability of a noVel Community HeAlth Workers (CHWs) programMe in imProving maternal and child health in Nigeria (REVAMP project). 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. Assessment of ITS design against quality criteria. Stame N. Theory-Based Evaluation and Types of Complexity. Keywords: Dementia, Home care, Person-centred care, Realist evaluation, Study protocol Background Dementia is an age-related condition. Second, gaps in the literature on the CHWs, combined with an increasing interest in applied research from policymakers and funders, create a favourable environment for the study provide a timely contribution to an on-going debate about effectiveness of complex CHW interventions. [1] It is based on the epistemological foundations of critical realism. Pawson R, Tilley N. Realistic Evaluation. One SURE-P component focused on maternal and child health (SURE-P/MCH), which comprised supply and demand components. BMC Public Health. Pawson R, Tilley N. Realist Evaluation. J Dev Econ. Resources Overview Realist Synthesis: An Introduction: This paper presents an introductory overview of realist synthesis as applied to the review of primary research on healthcare systems. We expect to have 30–45 IDIs to represent views of key actor groups in Anambra state (10–15 per each cluster) and about 30 at federal level. The assessment of the ITS design against standard quality checklist [42] is shown in Additional file 1. The study is guided by the research questions shown in Table 1, alongside the corresponding objectives. 2012;10(1):38. Results: A protocol for a mixed methods realist evaluation was developed to gain insights into the mechanisms that foster successful results in ICPs. During step 1, we will develop specific hypothetical pathways (i.e. the Charter of Fundamental Rights of the EU) and international conventions (e.g. Although there are excellent examples of how realist evaluation might be used for evaluation in different healthcare contexts (e.g. This may include the range of other services offered and occupancy levels. The additional costs on the supply side are likely to be training midwives and CHWs, salaries, equipment and other supplies (Table 2). The quality of government and programme indicators will first be assessed by comparing the data with relevant indicators from the demographic surveillance system, and we will adjust the HMIS/M&E variables accordingly in the case of major discrepancies. Specific methods of communicating research will include combinations of: Developing short and practical policy briefs to national and international policymakers and practitioners. Using IDIs, we will explore actors’ understandings and views about the intervention’s context and processes (or mechanisms), their expected and unexpected effects (outputs and outcomes) and effects of advocacy and lobbying in entrenching the MCH on the political agenda. t is a covariate and ε Implementing community-based perinatal care: results from a pilot study in rural Pakistan. LGAs will be selected in the discussion with State MOH policymakers and programme managers based on high maternal mortality ratios and existence of effective and committed district health leadership. Excerpt "A realist approach assumes that programs are “theories incarnate”. Adequate communication of results is an essential component of this study. It describes five key ideas which frame realism and their implications for impact evaluation. A realist evaluation study protocol. The 5-year duration is feasible and should allow sufficient time for developing robust multidisciplinary methodology, assessing longer-term outcomes, conducting individual and organisational capacity strengthening [44], adequate consultations with actors and facilitating uptake of project results into policy and practice [45]. BMJ. Its overall place in the toolkit of evaluation approaches is not yet fully established. NPHCDA. The aim of this study is to inform strengthening, scaling up and ensuring sustainability of CHW programmes. Studies have explored the effectiveness of CHW programmes in improving MCH outcomes [14, 15], productivity of CHWs [12], costs and cost-effectiveness of CHW initiatives [4, 16], power relations and acceptance of CHW programmes by the public [6, 17] and effectiveness of associated conditional cash transfers (CCTs) linked to uptake of services [18, 19]. Informed consent will be obtained from all study participants, and in the case of refusal, alternative means of data collection will be explored (e.g. Lehmann U, Gilson L. Actor interfaces and practices of power in a community health worker programme: a South African study of unintended policy outcomes. Evidence from elsewhere [43] is that demand-side programmes can impact on other services, through over-crowding and excessive bed-occupancy. Implementing accountability for reasonableness framework at district level in Tanzania: a realist evaluation. Abuja, Nigeria: National Primary Health Care Development Agency; 2012. Evaluation. Google Scholar. As with all primary research approaches, guidance on quality assurance and uniform reporting is an important step towards improving quality and consistency. "Understanding integrated care pathways in palliative care using realist evaluation:a mixed methods study protocol",, Creative Commons Attribution-ShareAlike License, This page was last edited on 19 July 2019, at 00:28. Spill-over effects and unintended consequences of the programme will be tracked, quantified and also explored qualitatively. Green A, Thomas C, Newell JN, Baral SC, Byanjankar L. The contribution of volunteers to a successful community-orientated tuberculosis treatment centre in an urban setting in Nepal: A qualitative assessment of volunteers' roles and motivations. Quantitative methods will include analysis of quantitative and costing data from (a) HMIS, (b) SURE-P M&E and (c) a structured facility exit survey. PubMed Central  Informed consent will be obtained from all study participants, and in the case of refusal, alternative means of data collection will be explored (e.g. studies, policy documents and so on) and so it is a form of secondary research. Cost effectiveness analysis of strategies for maternal and neonatal health in developing countries. One of the tasks of a realist evaluation is therefore to make the theories within a program explicit, by developing clear hypotheses about how, and for whom, 2005;352(20):2091–9. This paper describes our longitudinal, mixed methods realist evaluation of HNA and care planning. 2007;101(2):95–105. The demand component of the SURE-P/MCH programme aimed to increase utilisation of health services during pregnancy and at birth through the use of CCTs, i.e. individual), meso (organisational) and macro (i.e. is a dependent outputs (e.g. Sensitivity analysis captures the influence on cost-effectiveness ratios of change in major assumptions [16]. Research Methodology. This study will make an important and timely contribution to health systems strengthening in Nigeria. Implementation Sci 11, 83 (2015). Mirzoev T, Omar M, Green A, Bird P, Lund C, Ofori-Atta A, et al. Realist evaluation reports need to be developed in line with the realist nature of the evaluation. t Lindsay B. Randomized controlled trials of socially complex nursing interventions: creating bias and unreliability? Theory-driven forms of evaluation help understanding such complexity by studying how the different elements are intertwined [20] and recognising the role of context as a key influence in the production of outcomes [21]. The IWTs subsequently guided the identification of the specific information areas for the data collection and analysis. It explains when a realist impact evaluation may be most Methods and analysis The study will be conducted in four phases. R Pawson, N. Tilley, "Realistic Evaluation" (Sage), London. The realist evaluation is a relatively new approach to evaluation and its overall place in the is not yet fully established. We will select three study clusters, corresponding to Local Government Areas (LGAs): one with SURE-P/MCH, one with SURE-P/MCH + CCT and one with no intervention. The two interventions (i.e. The UK Medical Research Council (MRC) guidance for evaluating complex interventions also states that process evaluation can help ‘assess fidelity and quality of implementation, clarify causal mechanisms and identify contextual factors associated with variation in outcomes’ [22]. Adam T, Lim SS, Mehta S, Bhutta ZA, Fogstad H, Mathai M, et al. A favourable policy environment within which the study is conducted will ensure the successful uptake of results into policy and practice. Rather, becoming competent at realist evaluation involves acquiring the ability to think, reflect and interpret data in a way that is resonant with realist philosophy and principles. Implement Sci. Ethical approvals for this study were obtained from the School of Medicine Research Ethics Committee at the Faculty of Medicine and Health at the University of Leeds (ref: SoMREC/14/097) and the Health Research Ethics Committee at the University of Nigeria Teaching Hospital, Enugu (ref: NHREC/05/02/2008B-FWA00002458-1RB00002323). The PubMed Central  The study results will also inform strengthening the different aspects of the Nigerian health system, e.g. A cluster is made up of four PHC facilities and one General Hospital (GH). PubMed Google Scholar. Disabil Soc. Protocol for a mixed methods realist evaluation of regional District Health Board groupings in New Zealand Tim Stokes , 1 Carol Atmore , 1 Erin Penno , 1 Lauralie Richard , 1 Emma Wyeth , 2 Rosalina Richards , 3 Fiona Doolan-Noble , 1 Andrew R Gray , 4 Trudy Sullivan , 5 and Robin Gauld 6 organisations and their roles) and micro level (e.g. The supply component also included infrastructure development, improving availability of supplies and medicines and activation of Ward Development Committees (WDCs). The multidisciplinary and mixed methods realist approach that will be used in the study will facilitate such evaluation. London: Medical Research Council; 2008. acceptability of the intervention by the communities and front-line service providers, appropriateness of the intervention design to the current context of PHC facilities in Anambra state and sustainability of changes achieved from the implementation of interventions in the longer term [37].
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