Definition(s)

Implementation Science (IS) is a relatively new but rapidly growing field intended to put research findings into practice. IS was established to study the most effective strategies to integrate evidence-based interventions into public and community health and healthcare delivery. IS asks whether an intervention can be delivered effectively in a specific local context, that is, under what conditions and in what contexts can any change-oriented action be effective?

Why Do We Need Implementation Science?

Several definitions of IS are in use, with different fields adopting their own approaches, methods, and tools. One widely cited definition can be found in the introductory editorial to the first issue of the journal Implementation Science:

Implementation research is the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services and care. This relatively new field includes the study of influences on healthcare professional and organisational behavior.

(Eccles and Mittman 2006, 1)

This definition characterizes much of implementation research, yet it has a narrow focus on healthcare alone and does not include public health.

Other fields define IS broadly to include health research in general (Peters et al. 2013) and policy (Nilsen et al. 2013). This emphasis is reflected in the definition used by the National Cancer Institute, which includes public health and policy:

Implementation science (IS) is the study of methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine health care and public health settings to improve our impact on population health.

(National Cancer Institute 2020)

This definition, with slight variations in wording, is widely used throughout the US National Institutes of Health (NIH). These two definitions refer to methods employed to utilize research findings and put evidence into practice to improve human health.

Yet, not all implementation research occurs in health-related areas. Indeed, the field of education is engaged with IS especially in school psychology (Durlak 2015; McHugh and Barlow 2010). Referring to psychology in education, Kelly and Perkins define IS as “the study of the processes and methods involved in the systematic transfer and uptake of evidence-based practices into routine, everyday practice” (Kelly and Perkins 2012, 4). Similarly, Nordstrum and coauthors view IS as a research approach used to enhance the reach, adoption, use, and maintenance of innovations and discoveries in diverse educational contexts (Nordstrum, LeMahieu, and Berrena 2017).

Another field that engages IS is social work, which employs a broad, inclusive definition:

Implementation science is the scientific study of methods that examines the factors, processes, and strategies at multiple levels (e.g., clients, providers, organizations, communities) of a system of care that influence the uptake, use, and ultimately the sustainability of empirically-supported interventions, services and policies into practice in community setting.

(Cabassa 2016), 539

Knowledge translation is a closely related field with a slightly different emphasis on translation. Developed and widely used in Canada, it is defined by the Canadian Institutes of Health Research as “a dynamic and iterative process that includes synthesis, dissemination, exchange and ethically-sound application of knowledge to improve the health of Canadians, provide more effective health services and products and strengthen the health care system” (Canadian Institutes of Health Research 2020).

All these definitions have several elements in common:

Development of the Field

Research has produced a substantial body of knowledge that can improve human health and well-being. Much of that knowledge is published, yet read only by other researchers. Alternatively, research findings may be thought of as EBPs that are interventions or innovations designed to improve health and healthcare universally. Most of this evidence, however, is knowledge obtained under specific, controlled research conditions designed to prove validity and replicability (e.g., randomized control trials). Yet, the world in which humans live their everyday lives, and where care is delivered and received, tends to be complex and “messy.” Thus when these EBPs are employed in the scientifically uncontrolled world, they are frequently ineffective.

It was generally assumed by the scientific research community that basic clinical research, designed with a focus on clinical and health outcomes but without considering application in real-world settings, would eventually result in successful implementation of EBPs applied in practice (Douglas and Burshnic 2019; Goldstein and Olswang 2017). Known as the “traditional research pipeline” (Westfall, Mold, and Fagnan 2007) (see Figure 1), this process of translating basic clinical research findings into practice was assumed to happen and not well-studied. Establishing an innovation’s effectiveness (through controlled trials of performance under “real-world” vs. controlled research settings) (Singal, Higgins, and Waljee 2014) does not guarantee its uptake into routine usage. Further delaying uptake into everyday practice is the considerable length of time for research findings to be published, such that the findings may no longer be relevant because situations and contexts may have changed by time of publication. Classic studies indicate that it takes 17–20 years to get clinical innovations into practice; moreover, only 14% of clinical innovations make it into general usage (Balas and Boren 2000; Morris, Wooding, and Grant 2011; Mosteller 1981).

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Figure 1. A diagram outlining the traditional research pipeline.

Source: Westfall, Mold, and Fagnan (2007).

The seeds of understanding this gap between what is known to be best practice and what is done in practice in the real world began in the last century. Rogers’s Diffusion of Innovations and similar work in other fields sought to understand the social context of the spread of knowledge and innovations (Bauer and Kirchner 2020; Dearing and Cox 2018; Rogers 2003). As the field of IS has begun to formalize, developing and understanding the processes of uptake by which interventions become routine practice have become a primary concern, with a particular focus on diverse contexts across healthcare, policy, and public health (Bauer et al. 2015). Given the focus of IS on local contextual factors that affect uptake of EBPs, engaging stakeholders is at the core of implementation research. This emphasis also makes IS poised to innovate research that improves equity and reduces disparities; IS can leverage postcolonial, reflexivity, structural violence, policy and governance, and social justice theories “to achieve health equity . . . by a critical theoretical foundation that evaluates structural inequality, power, and reflexivity” (Snell-Rood et al. 2021, 1).

Numerous attributes make IS unique among other types of research in healthcare:

Theories, Models, and Frameworks in Implementation Science

Implementation Strategies

What implementation strategies will facilitate change? In other words, what will create a change that will lead to a new practice being adopted? What might a field team do, based on their TMF, that will result in the implementation and health-related outcomes that they are hoping to achieve? Implementation strategies are defined as “approaches or techniques used to enhance the adoption, implementation, sustainment, and scale-up (or spread) of an innovation” (Kirchner et al. 2020, 2; Powell et al. 2015, 2019; Proctor, Powell, and McMillen 2013).

Implementation strategies are similar to other concepts of change in other fields (e.g., QI), but as IS develops as a distinct field, researchers strive to make these strategies standardized and generalizable. Since all implementation research is context-specific, there must be a balance between choosing an EBP to implement a change that is targeted for the specific context but also is still relevant to other interventions in similar contexts. In an introduction to implementation strategies for psychiatry, Kirchner and colleagues explain these efforts: “Thus, as with other sciences, implementation science strives to characterize its variables with sufficient levels of abstraction to support aggregating knowledge obtained through multiple studies” (Kirchner et al. 2020, 1).

One attempt by IS researchers to make implementation strategies more generalizable was in the Expert Recommendations for Implementing Change (ERIC) study (Powell et al. 2015). ERIC cataloged 73 discrete implementation strategies (e.g., create new clinical teams; audit and provide feedback; identify and prepare champions; use capitated payments). IS experts then organized the strategies into nine broad categories using a concept mapping exercise (similar to pile sorting and ranking in cultural domain analysis) to facilitate an understanding of the type of change (Waltz et al. 2015). Proctor and colleagues proposed guidelines for naming, defining, and operationalizing implementation strategies in terms of seven dimensions: actor, the action, action targets, temporality, dose, implementation outcomes addressed, and theoretical justification to standardize descriptions so that they are precise enough to enable measurement and reproducibility (Proctor, Powell, and McMillen 2013).

Implementation research has sought to develop a structured approach to link implementation concepts and strategies to address specific contextual domains, such as those included in CFIR (Waltz et al. 2015, 2019). Waltz and colleagues produced a mapping scheme for barriers to strategies in a publicly available tool: the Implementation Strategy Matching Tool (CFIR-ERIC), based on a survey of implementation experts (Waltz et al. 2019). Qualitative approaches are often used to understand how implementation strategies are developed or chosen. Qualitative data also can identify the mechanisms of change that explain how the strategies affect specific contextual determinants. For example, Springer and colleagues conducted interviews with hospital providers and staff to understand one hospital’s experience selecting and implementing an “audit and feedback” intervention (Springer et al. 2021). Springer and colleagues’ qualitative approach allowed them to understand the choices made by implementers in the development and use of implementation strategies.

Implementation Processes and Outcomes

Exploration

Exploration is the primary stage in which qualitative methods can be used in IS. In this phase, the needs of the stakeholders are assessed and decisions regarding the implementation of an EBP are made. Rapid ethnographic assessment or ethnographic site visits can be an ideal methodology to make these assessments and begin to explore next steps such as intervention adaptations and context-specific implementation strategies. Simultaneously, stakeholder engagement is initiated through open-ended interviews, focus groups, and review of policies or public-facing documents, along with a general exploration of context surrounding the organization, patient population, or community.

Preparation

The Preparation phase begins when the decision is made to implement an innovation or EBP in the setting. Often the work of anthropologists and other qualitative researchers is utilized in this phase to adapt the EBP to fit the setting and create an implementation plan that addresses likely facilitators and barriers. Qualitative researchers may conduct additional interviews and focus groups with stakeholders to understand their views of the planned EBP and the barriers and facilitators they perceive to implementation in their setting. This data is used to adapt the EBP and create the implementation plan. It can also lay the foundation for rapport building with the stakeholders as a way of demonstrating that the implementation team has listened to and understood their perspectives and worked to address their concerns, critical for ensuring a supportive implementation climate.

Implementation

In the Implementation phase, the EBP is initiated and monitored. The engagement of anthropologists and other qualitative researchers depends heavily on the research plan. The types of designs employed involve evaluation designs, including formative, process, and summative evaluations. Although each type has distinct objectives, qualitative researchers are often part of the data gathering and analysis processes. For formative evaluation, the research design is focused on learning how the implementation is going and what adjustments could be made to improve it. Ethnographic site visits, interviews, focus groups, and observations are ideal methods for this type of design. In particular, rapid ethnographic assessment can be beneficial with its focus on gathering a comprehensive understanding of the process in context within a short, well-defined time frame. It is important to note that formative evaluation can be used to inform adaptations to the EBP or implementation strategies depending on the predetermined research design. For example, if fidelity to the EBP is important, qualitative researchers can observe whether the EBP is being delivered as designed, while providing data and analysis to support adaptations to implementation strategies in an effort to improve outcomes.

Process and summative evaluation designs are used when fidelity to EBP and implementation strategies are central to the research design. With process evaluation, researchers monitor and collect data on how the EBP are being delivered; they also focus on whether and how the implementations strategies are being utilized. Researchers do not share the data and analysis with the team with the intent of making adaptations and changes. Summative evaluation has the same objectives. However, the research team conducts the data gathering at the “end” of the implementation period to take advantage of hindsight to examine what supported implementation and the challenges faced in the process.

A well-defined research plan is critical for ensuring the implementation research team meets its objectives. The implementation team and the research team are often made up of the same team members. Most, if not all, implementation scientists recognize the importance of understanding context to be able to adapt the EBP and/or implementation strategies to fit the context or address the related barriers. Thus, a formative evaluation design is often employed. The role of anthropologists and other qualitative researchers is to understand the context and barriers and offer feedback on the analysis to the team to improve adaptation. Similarly, they could be part of the team that creates the adaptations. However, if fidelity to the EBP and/or implementation strategies is central to the research design, it is important for anthropologists and other qualitative researchers to remain detached from the implementation team and keep some “objective” distance to observe and document the process during (process evaluation) or following (summative evaluation) the implementation.

Sustainment

In the Sustainment phase, the focus is on ensuring that the supports are in place to help EBP continue. Ideally, the phases of EPIS lay the foundation for sustainment, while the qualitative research contributes to this foundation. However, research designs could target a long-term plan for follow-up or a visit to the setting to re-examine any changes. Qualitative methods can be used including ethnographic site visits, interviews, focus groups, document review, and observations.

While EPIS is helpful in delineating individual phases of the implementation research process in which ethnographic and qualitative methods can be effectively applied, the China/US Women’s Health Project demonstrates the strength of using ethnographic methods through the whole process from exploration to preparation to implementation and finally sustainment. The project team conducted an intensive ethnographic study on the implementation of an intervention to promote female condom use among sex workers in four communities in China. The research was a partnership between US and Chinese researchers, the Centers for Disease Control and Prevention (CDC), and provincial-level and local healthcare and public health organizations. The research design included 6 months of formative work to observe and map the local sex worker establishments and the intersecting organizations. This work could be characterized as Exploration and Preparation in the EPIS framework. It laid the groundwork for tailoring implementation to the communities. The intervention was implemented over a 6-month period; pre-/post-intervention surveys were used to document implementation and health outcomes. Finally, the design included a 6-month sustainment phase. Of the several publications that document the study and its outcomes (Liao et al. 2011; Weeks et al. 2010), a 2013 publication by the team (Weeks et al. 2013) demonstrates how the ethnographic data from each stage of the study allowed them to map the multilevel systems impacting sustainment of the intervention and the variations across sites.

An additional research design that does not fit the EPIS phases is studying implementation of a policy as a natural experiment (Théodore et al. 2019) or the use of implementation strategies in clinical settings that are not part of a formally planned study (Goedken et al. 2019). Such research designs take advantage of the implementation of a policy, EBP, or implementation strategy and examine how the people in the setting implement and explore their decisions. Ethnography works well in these situations. In addition, rapid approaches to ethnographic data collection and analysis are increasingly used in IS due to the demands of the research time frame or needs of clinical partners. While many implementation scientists rely on rapid ethnographic assessment (Beebe 2014; Sangaramoorthy and Kroeger 2020), Palinkas and Zatzick (2019) developed the method of Rapid Assessment Procedure-Informed Clinical Ethnography specifically in the context of IS.

Finally, participatory action research and community-based participatory research designs often are combined with qualitative and ethnographic methods to ensure all perspectives are included in IS, often to counter unequal power structures and ensure those excluded from decision-making positions are integrated in the process. Morton Ninomiya and colleagues describe their work to decolonize approaches to alcohol prevention programs among the people of the Sheshatshiu Innu First Nation in Canada (Morton Ninomiya, Hurley, and Penashue 2020). Their work led to exploring interventions to prevent fetal alcohol spectrum disorder and care for children with the condition, preparing interventions designed with Sheshatshiu Innu First Nation and provincial and national practitioners and researchers together. Then implementation shifted to the Sheshatshiu Innu First Nation, which supported the sustainment of the program. In each of these research designs and approaches, ethnography is central to widening the lens on understanding what makes implementation successful.

Why We Need More Anthropology in Implementation Science

It is apparent that IS is an important field for solving human problems, and one in which anthropologists should be highly involved given some of the congruences between anthropology and IS. Yet, the rationale for having more anthropology in IS goes beyond the case that there is a good fit. A more important reason is the vital contributions that anthropology can make to IS.

Generally, anthropology can be seen as the holistic study of humanity, past and present in all of its aspects including cultural, social, linguistic, and biological. IS, by contrast, emerges from a Western perspective (Boulton, Sandall, and Sevdalis 2020). Consequently, IS assumptions and values about sociocultural phenomena such as organizations and institutions, including family and social relationships, tend to reflect the dominant cultures of Europe and North America. Although there is a growing movement to apply IS globally (Bertram et al. 2021; Ridde, Perez, and Robert 2020; Shelton et al. 2020), there is generally limited attention to cultural differences, power, and structural barriers.

One of anthropology’s greatest attributes is its ability to raise awareness of the sociocultural world in which people live but do not “see” the cultural patterns that surround them. Anthropology can be especially important in helping IS understand the contexts in which implementation occurs and identifying cultural blind spots in perceptions and understandings (Cohen et al. 2008). Indeed, anthropologists have sought to understand context, remove cultural blinders, and make behaviors, beliefs, attitudes, and other aspects of human life and functioning apparent.

Agar’s concept of the “Professional Stranger” (Agar 1980) is relevant to IS: an ethnographer who encounters a culture or society as an intentional outsider, that is, an intentionally uninformed member of society (Granosik 2011) so as to learn about it from that society’s members. Implementation researchers rarely take this position. Rather, implementation researchers usually assume the role of an expert seeking to characterize a context rather than understand. Anthropology’s use of this inexpert, knowledge-seeking role can contribute greatly to IS understanding of all aspects of context.

Beyond methods and approaches, anthropology attends to power structures and discrepancies in power among stakeholder groups, phenomena that, while sometimes acknowledged in IS, are not frequently critiqued. Anthropologists can provide a questioning, critical perspective of the object of study and how it is studied, a perspective that is lacking in much IS work. Anthropologists can foster awareness of needs for structural, organizational, or policy changes to improve health and healthcare, beyond the implementation of an EBP. They can explore specific power inequities and the organizational, political, or economic structures that normalize these discrepancies. Anthropologists can help the still-developing field of IS to do more than implement EBPs. They can help increase the power of evidence through critical implementation. That is, with a critical eye to power, we can bring unhelpful or unjust power discrepancies to light. Then, interventions could go beyond appropriateness to context and also lead to transformation of context through a critical approach to implementation (Peek et al. 2014).

Implementation researchers typically hold a position of power vis-à-vis the groups with whom they are working. Power differentials are established based on research knowledge and expertise, which is prioritized over local or practice-based knowledge during the implementation process. Anthropologists’ use of reflexivity to examine their perspective, bias, and role in the research process could apply more broadly to IS (Snell-Rood et al. 2021). Reflexivity provides a different lens to address power and inequity in the field.

Anthropology is positioned to answer the questions IS poses, since anthropological theory and methods allow an understanding and brokering of both emic and etic perspectives, as well as an in-depth exploration of the richness, fluidity, and complexity of context. Yet, anthropology is far from the dominant discipline working in IS where psychologists, nurses, and physicians are found in abundance. In fact, IS is an interdisciplinary and public-oriented field. There is great interest at the NIH, the CDC, the Agency for Healthcare Research and Quality (AHRQ), the Patient Centered Outcomes Research Institute (PCORI), and the Department of Veterans Affairs (VA) because IS is oriented towards making research useful for the public.

Examples of Anthropologists Doing Implementation Science