Part II: The Global Strategy
2. Control: Overcoming Malaria
4. The Malaria Research Agenda: C. Operational and Implementation Research
Operational and implementation research inform decisions about the effective implementation of scale-up, sustained control and elimination activities at country and district level. As with research to inform policy, significant additional financial resources and human capacity are needed.
WHO defines operational research (OR) as "the use of systematic research techniques for program decision-making to achieve a specific outcome. OR provides policy-makers and managers with evidence that they can use to improve program operations."Framework for Operations and Implementation Research in Health and Disease Control Programs. WHO-TDR and the Global Fund
to fight AIDS, Tuberculosis and Malaria, 2008.
Click for source The purpose of implementation research, as stated by WHO – the Special Programme for Research and Training in Tropical Diseases (TDR), is to "significantly improve access to efficacious interventions against tropical diseases by developing practical solutions to common, critical problems in the implementation of these interventions".Framework for Operations and Implementation Research in Health and Disease Control Programs. WHO-TDR and the Global Fund to fight AIDS, Tuberculosis and Malaria, 2008.
Click for source
Operational and implementation research helps to identify solutions to bottlenecks that limit program quality, efficiency and effectiveness, or to determine which alternative service delivery strategy would yield the best outcomes. At its best, the results of this research increase the performance of programs on both country and global levels. Operational and implementation research, while separate and distinct, links closely with M&E, described in more detail in Part IV - Chapter 9: Monitoring and Evaluation. Generally speaking, M&E is the routine tracking of program performance and the periodic evaluation of this performance, including outcomes and impact.
Historically, limited funding has made it difficult for operational and implementation research to keep pace as control measures has been scaled up, both for malaria and other health conditions. For example, current intervention field effectiveness is often much lower than its potential and varies significantly based on setting. Non-adherence to challenging drug regimens, improper use of LLINs and washing walls post IRS, are just some of the causes of the lower effectiveness that need to be assessed.
Operational research in malaria is sponsored by several large international partners, such as the World Health Organization, Multilateral Initiative on Malaria / Research and Training in Tropical Diseases (MIM / TDR), Bill and Melinda Gates Foundation, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and several bi-lateral organizations. WHO-TDR and the Global Fund have recently developed an operational framework to standardize the operational research carried out in countries. The Global Fund will be compiling a database of past and ongoing operational research activitiesJoint WHO-TDR/TGF Consultative Technical Meeting on the Framework for Implementation/Operational Research in Health and
Disease Control Programs, Geneva, April 2008.
Click for source that are funded by Global Fund grants. All of this should add to lessons learned and best practices for malaria control.
Challenges in the control stage. Several key questions and challenges exist in scaling up interventions which could be addressed by operational research.
Delivery of LLINs. Debate still exists surrounding the most effective mechanisms for delivering LLINs. While many approaches can be successful depending on the context and sophistication of a country's control program and health system, greater understanding is needed of the appropriateness of campaigns vs. routine distribution (public and/or private), in initial scale-up and in replacement while sustaining control.
Insufficient health systems research. Research into general health systems that is relevant across diseases should be a priority: understanding the key bottlenecks to achieving universal coverage and utilization, and defining optimal solutions for minimizing them will be very important, particularly as countries move into sustaining control. Research into effective integrated, multi-disease programs which incorporate malaria will be helpful. Testing alternative and improved delivery strategies (e.g. community health workers, mobile clinics, mass campaigns) will also help program managers achieve universal coverage. For example, questions exist regarding optimal roles for the public and private sector in improving access and how the roles evolve as the control program reaches certain milestones. This would be impacted by public and private sector capacity in the country and the types of populations targeted. Economic analysis is also needed to assess how different delivery systems affect cost effectiveness.
Operational research on which mechanisms enable interventions to reach the poor and vulnerable groups, including women and young children, is also needed. Currently evidence is limited: small scale projects have been undertaken, but there is much less experience sustaining quality services on a large scale over time (e.g. sustaining drug supplies, or the motivation and quality of care among community health workers).
Behavior change research. Behavioral research will be necessary to help ensure preparedness for implementation of strategies, particularly surrounding those of new interventions and approaches. For example, increasing focus on parasitological diagnosis in more transmission settings across age groups will require significant behavior changes. Research focused on optimizing behavior change communication (BCC) and information, education and communication (IEC) approaches, which can improve intervention uptake, usage, and adherence, and on mechanisms for sharing best practice approaches should be developed.
Research for monitoring and surveillance technologies. Lastly, research is needed on the feasibility of new monitoring and surveillance systems. Several new applications utilizing mobile phone, SMS and PDA technology have the potential to increase frequency and accuracy of data collected. A greater understanding of which tools are most applicable in which settings will be helpful, particularly as surveillance becomes more critical.
Current activities. Several groups have begun defining key operational and implementation research for malaria. The RBM Malaria In Pregnancy Working Group (MIP) has developed a list of questions related to pregnant women and malaria, while the WHO Special Programme for Research and Training in Tropical Diseases (TDR) has done similar work for case management. Box II.7 contains an example from the RBM Scalable Malaria Vector Control Working Group (WIN) of its proposed operational and implementation research agenda for vector control.
Box II.7: An Example – Operational and Implementation Research Needs for Scalable Vector Control
From the RBM Scalable Malaria Vector Control Working Group (WIN)
The RBM WIN Working Group has identified a set of questions that could be answered by operational and implementation research. While questions must still be prioritized, they are listed below:
- What are the barriers to effective universal coverage and use of LLINs (system, political, operational, cultural, household, etc.) and how do we mitigate them? (includes reasons for sub-optimal use)?
- What are the optimal LLIN replacement strategies and thresholds, and how do we forecast needs for achieving and sustaining high coverage levels?
- What are the marginal costs and benefits of combining IRS with LLINs under varying strategies?
- What are the marginal costs and benefits of two versus one annual round of IRS in perennial transmission settings?
- Why is LLIN use low among pregnant women and how can use be improved?
- How can we better measure the useful life of LLINs under real life conditions?
- What options exist to strengthen and streamline national regulatory systems and regional support and how well do these work?
- What is the entomological and epidemiological impact of scaled-up LLINs and/or IRS (incl. social acceptability)?
- Can combined full coverage of LLINs and IRS push transmission to zero in highly endemic areas of sub-Saharan Africa (under what time frames and strategies)?
Challenges in the elimination stage. Very little operational and implementation research exists for countries in elimination.
High transmission settings. There is currently little knowledge on elimination approaches for higher-transmission settings. For countries currently in elimination, more operational research is needed to identify best practice approaches in these and other diverse geographical settings. As higher transmission countries reduce burden to levels where elimination becomes feasible, specific research should be undertaken to understand how elimination programs can be successfully implemented. Countries which have pockets of higher transmission may be good candidates for such studies, such as South Africa, Swaziland and Botswana.
Additionally, as cross-border collaboration becomes more important due to porous borders and transient populations, greater understanding of best practice approaches will be helpful to countries. This includes guidance on assisting adjacent countries which may have lower resource levels and/or humanitarian crises which make malaria control, particularly with population movements, even more challenging.
- Significant additional financial resources and human capacity are needed to address all of the operational and implementation research priorities.
Priorities for scaling up and sustaining control. Several activities should be started in the short-term to help with the immediate needs of scale-up as well as the medium-term goals of sustaining control:
- Research surrounding mechanisms for replacement of LLINs and best practice recommendations based on setting and country capacity;
- General health systems research to identify approaches for reaching hard-to-reach populations, determine optimal roles for different sectors, increasing access to treatment, etc;
- Behavioral research to inform effective practices for improving uptake, usage and compliance with interventions; and
- Research on new M&E technologies.
Priorities for elimination. Increased operational research related to elimination would significantly benefit countries currently in this stage, as well as help define objectives and strategies for countries that could embark on elimination in the medium- to long-term. Priorities include:
- Greater understanding of and solutions to common elimination challenges, such as the control of malarious borders and transient populations; and
- Research on elimination approaches for formerly high transmission settings.
Organization Implications: Developing the Agenda for Operational and Implementation Research
Several research gaps exist around effective delivery of and access to available tools and treatments during the scale-up stage, including comprehensive approaches for difficult-to-reach populations. Many groups (e.g. the Scalable Malaria Vector Control Working Group, the Malaria in Pregnancy Consortium) have set operational research agendas for malaria and have identified operational research needs and opportunities that could be addressed. However, a common global agenda is still needed, as well as clear designations regarding who or which organizations should focus on specific research questions and a way to collate and disseminate findings.
As with the Research to Inform Policy recommendations, a group including all major stakeholders should be convened regularly to determine and refine the global operational and implementation research agenda. Additional RBM Working Group involvement could be coordinated through the RBM Secretariat-based focal point recommended earlier. Even if separate groups and mechanisms are created than those for research to inform policy, they should be closely linked.