Implementation research: Road map from research to practice

Abstract

The challenge today is to make sure that the evidence available gets implemented for betterment of human wellbeing. The research which is closely associated with implementation, challenges and outcome of evidence in real life scenario is Implementation research (IR). The current prespective explains why there is a focus on IR by all icluding researchers, practitioners and policy makers. The approaches and study designs commonly used in the IR have been described. The IR is multi-disciplinary, multilevel and contextual in nature. The outcomes in IR are proximal. The article further describes the ethical issue and the way forward for IR. We need to do capacity building of practitioners, researchers and policymakers in IR.

Introduction

Over a period of time, there has been an increase in the number of proven interventions in many areas of medical science including public health.¹ The scope of evidence synthesis has also increased overtime with a robust methodology for the systematic review and development of the GRADE system.² However, when intervention proven in control environment by researchers are upscaled to real-life scenario, they are found to be ineffective because of social, cultural, and contextual factors. The policy makers are looking for evidence which can work in real-life scenarios. The challenge is to make sure that the evidence available gets implemented for the betterment of human well-being. This is where the role of implementation research (IR) begins.

IR is defined by Center for Disease Control (CDC) as “the systematic study of how a specific set of activities and designated strategies are used to successfully integrate an evidence-based public health intervention within specific setting”.³ There is an increasing importance given to IR by academia, researchers, policy makers, and funding agencies, including CDC, World Health Organization (WHO), National Health Systems Resource Center (NHSRC), Indian Council of Medical Research (ICMR), and so on. The number of increasing publications on IR in recent times also substantiates the growing awareness about IR (Fig. 1).

Fig. 1.

Counts for implementation research in Pubmed.

Why focus on implementation research?

Studies estimate an average of 17 years for new knowledge from randomized controlled trials to be incorporated into practice.⁴ Dissemination of evidence-based medicine is an effort to communicate customized information to target audience with the goal of engagement and information use whereas implementation is an effort specifically designed to get best practice findings into routine and sustained use through appropriate change or uptake or adoption of intervention. Dissemination is an integral part of implementation but dissemination alone does not seem to do much on their own to improve practice delivery and hence a required focus on IR. IR is the fundamental challenge for healthcare systems to optimize care, outcomes, and costs.

Broadly, the road map of research moves from basic research to clinical research paving the way into broader clinical practice. IR finds its place following the development of guidelines for practice, moving research into health practice through diffusion, dissemination, and delivery research (translation to practice).

The evidence generation for the newer technology/drugs/intervention is done in controlled settings which are under the control of the researcher. The upscaling of the proven intervention in real-life situation has not led to desired effects in community settings due to contextual, social–cultural, heath system, physical environment, and management factors. These newer interventions rarely define the “core” and “supplementary” features of newer intervention. At times, even the settings of the study are not fully described so as to make inference about the utility of finding in the practitioners own settings. The failure to identify the barriers before large-scale upscaling may lead to considerable financial losses and faith in health system. The science which concerns itself with implementation problems is IR. It is a scientific enquiry into what, how and why some health interventions work and does not work in the community settings. It draws its origins from several disciplines like sociology, anthropology, managerial sciences, and so on.⁵

There are multiple examples where an efficacious preventive and treatment method was not successful due to social and contextual factors. For example, Vaccine preventable diseases, prevention of non-communicable diseases, and so on for which sufficient evidence exists; however, they fail in different societal and contextual factors. Similarly, some of the program, like prevention of parent to child transmission, health insurance programs were not successful. Therefore, comprehending and capacity building in the IR is the need of the hour.

The IR demands much more complete and transparent reporting of factors, including settings, patient level participation, and maintenance of intervention at individual level and setting level. Pragmatic explanatory continuum indicator summary⁶ and the use of extended consolidated standards of reporting trials guidelines⁷ are two efficient ways of understanding and reporting IR.

Approach to implementation research

The IR approach is different from conventional research in the sense that it is not researcher driven. There are two approaches for the identification of the problem; one is the top-down approach wherein the policy maker/program manager identifies the problem and the other is the demand from public (bottom-up approach). The synthesis of the evidence of a single intervention is done using principles of systematic review and GRADE. However, in practice, there is lack of comparative effectiveness research-translation to identify the most effective intervention in the given context. Hence to apply one intervention for the given problem would require an understanding of the research (external validity), the system which includes the health system and also politico-cultural system, demography, and high-risk problem. This means that IR would be done at multiple levels involving multiple stakeholders. Therefore, IR or projects would include a systematic approach to discuss the evidence, comparative effectiveness including cost, multi-levels, health systems, and bottlenecks during implementation for implementing the research finding and making it sustainable for policy and practice. Another aspect is since the problem may be specific to a locality, the IR is contextual. Therefore, it is imperative for the IR team to give research findings as core elements and contextual elements.

The outcomes of IR are also different from conventional research. Proctor gave a conceptual model of IR which is widely used even now (Fig. 2).⁸ The outcome variable in IR are at three levels, client (satisfaction, improvement in performance in services), service outcome (efficiency, safety, effectiveness, equity, patient-centeredness, timeliness), and implementation outcomes (acceptability, adoption, appropriateness, costs, feasibility, fidelity, penetration, and sustainability).⁸ Implementation outcomes which are indicators of the success of effectiveness are different from system outcomes and individual level outcomes. These outcomes have different concepts and are explained in the next paragraph.

Fig. 2.

Proctor Conceptual model of implementation research.

Acceptability outcome is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable or satisfactory. Appropriateness is defined as the perceived fit and relevance of the intervention for a given context. It is also about the compatibility of the intervention. Feasibility is closely related to the concepts of trialability and refers to whether the given intervention is practical in the local context. Implementation cost (or incremental cost) is defined as the cost impact of an implementation effort and depends on the costs of the particular intervention, the implementation strategy used, and the characteristics of the setting(s) where the intervention is being implemented. Fidelity is an important concept and is defined as the degree to which an intervention was implemented as it was prescribed in the original protocol or as it was intended by the program developers. Fidelity is commonly measured by comparing the original evidence-based intervention and the disseminated and implemented intervention in terms of adherence to the program protocol, dose or amount of program delivered, quality of program delivery, and participant reaction, and acceptance. Sustainability is defined as the extent to which a newly implemented treatment is maintained or institutionalized within a service setting's ongoing, stable operations and becomes part of the process.

Study designs in Implementation Research

The main difference among study designs in conventional research and IR is that the study designs may be tweaked in IR as research progresses, meaning the study designs are adaptive. These adaptive designs may be both observation as well as intervention study design. The evidence is gathered using both quantitative and qualitative paradigm. They can be either employed individually or as mixed-methods. Mixed-methods designs involve the collection and analysis of multiple, both quantitative and qualitative data in a single study to answer research questions using a parallel (quantitative and qualitative data collected and analyzed concurrently), sequential (one type of data informs the collection of the other type), or converted (data are converted—qualitized or quantitized—and reanalyzed) approach. IR uses theories, frameworks, and explanatory models to provide insights into mechanism by which implementation succeeds or fails.⁹ Two of the most common frameworks used are Reach, Effectiveness, Adoption, Implementation, Maintenance and Consolidated Framework for IR.¹⁰ Both the approaches are meta-theoretical with multiple constructs within them. These theories not only help in understanding the outcome and results but also help in designing the IR.

Communication of the IR findings is another very important aspect. The findings need to be communicated to policy makers/program manager to bring out corresponding changes in the program, to the scientific world, to the community, and to all other stakeholders. The most effective means of dissemination should be identified for each stakeholder.

Ethical issue in Implementation Research

Ethical issue in IR presents a dilemma as the program implementer are stakeholders in the research team and the participants are those availing services of routine health care. The data collection needs to be anonymized and confidentiality to be maintained. The information should be disseminated in a way so as to prevent any harm to the participants or stakeholders in the research. The power balance in the research team as the research team involves multiple stakeholders at multiple levels to be looked into so as to minimize the risk arising from the research findings. The ethics in IR is evolving area and more guidelines may come up as experience accumulates.¹¹

Problems and way forward for Implementation Research

One of the problems facing IR is the use of common terminology for the IR. Translation research, knowledge transfer, operation research, and many terminologies are used for similar things. Developing and consensus on terminology is essential for this emerging field. There is a need to develop improved and standardized measurement in IR especially the concept like fidelity and adoptions which are more proximal. Capacity building in the field is limited with many researchers not aware of the theory and context and methodology in IR. The theories themselves may need improvement so that they may be applied over a wide scope of settings and contexts.

There is a need to incentivize the implementation of research by academia, researchers, and research agencies with dedicated fund for capacity building. There is a need to have dissemination policy for the policy makers and other stakeholders, tailor made for everyone to enable them to use information in real settings. At the national level, we propose to have a repository of the proven interventions in real-world settings especially in low and middle-income countries similar to the likes of United States and Canada but more contextual and local.

In summary, one of the greatest challenges facing the global health community is how to take proven interventions and implement them in the real world. IR is crucial to meeting this challenge. IR is relatively new and has come into sharp focus. Interest in IR is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions and guiding health policies.

Disclosure of competing interest

The authors have none to declare.