The sections below provide a high-level discussion of some of the changes made to the CFIR 2.0; for a detailed list of changes based on user feedback, see Additional File 4.
Framework-Level Updates
Addition of Framework and Domain-Level Guidance: Perceptions vs. Reality
The CFIR is a determinant framework: constellations of CFIR constructs help predict and/or explain implementation outcomes. In recognition that socially constructed perceptions, interpretations, and meaning lead to intentions or enacted behaviors (31), constructs are designed to capture the perceptions of individuals that have influence and/or power over the outcome of implementation efforts. This is now highlighted in response to user feedback asking whether constructs were intended to capture perceptions versus reality; however, the CFIR 2.0 also advises users to develop an a priori factual definition of the subject of each domain (see domain sections below). In addition, detailed guidance on applying and operationalizing the CFIR will be provided in a forthcoming manuscript.
Addition of New Constructs and Subconstructs
Constructs and subconstructs were added to address missing themes and further develop domains; the number of constructs and subconstructs increased in all domains except the Innovation Domain. For example, several constructs were added to better center Innovation Recipients in the CFIR 2.0, including in the Inner Setting Domain (Culture: Recipient-Centeredness), Individuals Domain (Roles: Innovation Recipients), and Implementation Process Domain (Assessing Needs: Innovation Recipients and Engaging: Innovation Recipients).
The addition of constructs better aligns the CFIR 2.0 with other published frameworks. For example, Nilsen and Bernhardsson evaluated 17 determinant frameworks with clearly distinguishable dimensions. They concluded that CFIR 2009 only addressed 10 of 12 identified dimensions; the framework now addresses all 12 dimensions with the addition of the Characteristic: Opportunity construct in the Individuals Domain, which captures dedicated time to implement and deliver the innovation, and the Structural Characteristics: Physical Infrastructure subconstruct in the Inner Setting Domain, which captures the physical environment (32). Although constructs were added to fill perceived gaps in the CIFR, framework-level guidance also encourages users to operationalize the CFIR for their project, including adding constructs as needed.
Revisions to Domain and Construct Names and Definitions
The names of constructs and definitions were updated in response to recommendations to make the framework more applicable across a range innovations and settings. For example, we use the term innovation rather than intervention and recipient rather than patient in the CFIR 2.0. Additional minor revisions were made to clarify information that was confusing to users in the CFIR 2009. For example, Evidence Strength & Quality was renamed Innovation Evidence-Base to clarify that the construct is intended to assess perceptions of the existing evidence-base, not the effectiveness of the innovation after implementation. Major revisions were made to correct inconsistencies in the CFIR 2009. For example, the definition of Innovation Complexity was updated to replace the text “complexity of implementation” with “complexity of the innovation.” Overall, every domain and construct had at least a minor revision. Domain-level updates are described below.
Innovation Domain Updates
Addition of Domain-Level Guidance: Innovation vs. Implementation Strategy
Users questioned whether the CFIR was intended to evaluate the innovation and/or the strategy being used to implement the innovation, and they found it difficult to differentiate between them. The literature has recognized that the lack of a clean boundary between the innovation and implementation strategies is a contributor to implementation complexity (33); differentiating the two helps ensure accurate attribution of constructs in each domain to implementation outcomes. As a result, the CFIR 2.0 guides users to define the innovation (aka “the thing” (34, 35) being implemented), including the boundary between the innovation and implementation strategies. We encourage use of a reporting framework to document the innovation, such as the Workgroup for Intervention Development and Evaluation Research (WIDER) (36), PICOT/PICOTS (33, 37), or the Simplified Framework for Interventions (AIMD) (38). These frameworks facilitate defining the type of innovation, the core versus adaptable components of the innovation, and the intended recipients of the innovation. In addition, the word Innovation was added to the name of each construct in the Innovation Domain to help orient users to the focus of this domain: the Innovation itself, independent of the implementation strategy.
Outer Setting Domain Updates
Addition of Domain-Level Guidance: Outer vs. Inner Setting
Many users described difficulty understanding boundaries between the Inner and Outer Settings. In Additional File 1 from the CFIR 2009, the boundary between Inner and Outer Settings was visually depicted using “overlapping, irregular, and thick grayed lines” to highlight that the line between them is not always clear (16). Lengnick-Hall et al. expand on this reality and call for researchers to take an “open-systems” perspective “to highlight interdependence between outer and inner contexts and [to] view organizations as part of a broader interdependent system that may range from simple to complex, rigid to flexible, and loosely to tightly coupled” (39).
Although it may be challenging, differentiation of internal and external influences on the performance of organizations has been a central tenet of organization science (40), and highlights the level at which to target any interventions. As a result, the CFIR 2.0 guides users to define the Outer vs. Inner Settings in a way that brings clarity to their project.
Addition of New Constructs & Subconstructs
Several constructs were added to the Outer Setting in response to critiques that the domain was underdeveloped (32, 41). The CFIR 2.0 adds constructs to capture the potential impact of Local Attitudes, e.g., community-level values and beliefs, and Local Conditions, e.g., community-level of affluence, on the willingness and ability of entities within the Outer Setting to support implementation and delivery of the innovation. These constructs are especially important for innovations that require support by community entities, such as Housing First models of care (42), and to capture common resource constraints in low income contexts (43).
The CFIR 2.0 also better captures diverse sources of External Pressures, including Societal Pressure (e.g., pressure from social movements and protests), Market Pressures (e.g., pressure to compete with and/or imitate peer entities), and Performance Measurement Pressure (e.g., pressure to meet publicly reported goals). This expansion of the Outer Setting brings the CFIR 2.0 into closer alignment with other implementation and policy frameworks (17, 44–46).
Inner Setting Domain Updates
Addition of New Constructs & Subconstructs
Constructs and subconstructs were added to the Inner Setting to address several critiques. For example, four subconstructs were added to Culture: Human Equality-Centeredness, Recipient-Centeredness, Deliverer-Centeredness, and Learning-Centeredness. These constructs were added to reinforce the importance of identifying and amplifying key voices (i.e., Innovation Recipients and Innovation Deliverers) and address issues related to oppression and equality at both a cultural and system-level. In addition, the inclusion of Recipient-Centeredness helps to more explicitly center Innovation Recipients in the CFIR.
Individuals Domain
Reorganization of Domain
Users were unclear which individuals were included in this domain and felt that the existing constructs overlapped with constructs in other domains and failed to capture more relevant characteristics. One user summarized this feedback well: “[The CFIR needs to focus] more on who the individuals are and their underlying characteristics.” As a result, the Individuals Domain was significantly restructured to include two subdomains: Roles and Characteristics.
Roles Subdomain
In the CFIR 2009, roles were spread across three different domains: Patient Needs and Resources was listed in the Outer Setting, Leadership Engagement was listed in the Inner Setting, and multiple implementation-specific roles were listed in the Process Domain (e.g., Formally Appointed Internal Implementation Leaders). These roles have been relocated to this new subdomain, and additional roles were added, including Implementation Team Member (47). In addition, the Formally Appointed Internal Implementation Leader and Champion constructs were combined into the Implementation Leads construct.
Characteristics Subdomain
The CFIR 2009 characteristics constructs were replaced with constructs based on Michie et al.’s COM-B system (48). The COM-B posits broad categories of Capability, Opportunity, and Motivation that shape behavior. We also added the Need construct, given that the needs of all constituencies are important determinants of implementation outcomes. We encourage users to replace or extend Characteristics constructs based on role-specific theories. For example, theories, models, and frameworks can be combined with CFIR 2.0 related to:
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Behavior change, e.g., the Theoretical Domains Framework (49, 50), the Theory of Planned Behavior theories (51), or the Social Ecological Theory (52), which may provide constructs relevant for Innovation Recipients and Innovation Deliverers
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Facilitation (53, 54) and project management (55, 56), which may provide constructs relevant for Implementation Facilitators or Implementation Leads
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Leadership (53, 54), which may provide constructs relevant High- and Mid-Level Leaders
These role-specific constructs may be mapped to the broader COM-B constructs; for example, all 14 domains and constructs in the Theoretical Domain Framework (TDF) are mapped to the COM-B (57).
Implementation Process
Addition of Domain-Level Guidance: Innovation vs. Implementation Strategy
CFIR 2.0 encourages users to describe their overall approach or implementation process framework guiding implementation, e.g., the Interactive Systems Framework (58) or the Knowledge to Action Framework (59). This helps distinguish the Innovation from the Implementation Process (see Innovation Domain above) as well as to prioritize or identify additional relevant constructs or subconstructs based on the specific strategies included in the implementation process.
Some users questioned the inclusion of the Implementation Process Domain in the CFIR 2009 because it includes strategies not contextual factors. As a determinant framework, the CFIR includes determinants related to several spheres of influence: the innovation being implemented, the individuals involved, the settings, and the implementation process. The goal of this domain is to capture the use and quality of these implementation processes as implementation determinants common across many process frameworks (32) and implementation science theories.However, as noted in the preceding paragraph, depending on the process framework used for a particular project, there may be other important components of the implementation process that should also be examined as determinants.
Addition of Constructs & Subconstructs
The CFIR 2.0 has expanded the number of constructs within the Implementation Process Domain in response to critiques that key processes and strategies were missing. Though it is outside the scope of the CFIR to include all 73 implementation strategies from the Expert Recommendations for Implementing Change (ERIC) (27), a few best practices have been added in the CFIR 2.0: Teaming, Assessing Needs, Assessing Context, Tailoring Strategies, and Adapting. The addition of the Assessing Needs: Innovation Recipients and Engaging: Innovation Recipients constructs also serve to better center Innovation Recipients in the CFIR 2.0.
Recommendation for Users: Center Equity as a Determinant and Outcome
Researchers have produced decades of findings focused on the role of individual (e.g., race) and structural (e.g., access to care) determinants of health in highlighting inequities in services and outcomes (60). However, we must move upstream, past spurious individual-level determinants (61) to recognize racism and other systems of oppression as the source of these outcomes (62–64). Lett et. al. challenge us all to center equity by asking ourselves: Who is represented in the study? How can this work cause harm (61)? This requires understanding our own positionality, i.e., who we are relative to who should have influence and/or power over implementation, being deliberate in collaborating with communities and deeply knowledgeable equity researchers, and prioritizing sustainability over urgency in research (61).
Implementation researchers are uniquely positioned to address oppression by seeking to understand how it manifests across all domains as a determinant to outcomes related to equity. Individuals using the CFIR (or other framework) have opportunities to subvert established systems of oppression by including and sharing power with members of historically excluded groups in implementation and evaluation. When first planning implementation of an innovation, researchers should use a multi-level approach to identify implementation strategies that will address health equity (65), e.g., including recipients and other community members in choosing and adapting the innovation and implementation strategies. When evaluating implementation, researchers should combine use of an equity-focused framework (e.g., the HEIF (66)) or broader theoretical lens (e.g., critical race theory (67)) to identify potential determinants and implementation outcomes (68), and be deliberate about including recipients and deliverers in identifying relevant measures and outcomes.
Although the CFIR 2.0 includes new constructs to better assess themes related to racism and oppression, the CFIR is a generalized framework and we urge users to use equity, justice, or non-discrimination theories with the CFIR 2.0 as a lens through which to view all facets of implementation (65) and to collaborate with experts in equity (61).
Limitations
A limitation of this work is that we only collected feedback from CFIR users (via the published literature and a survey). We purposefully focused on feedback from users because they are experts in the CFIR; they can provide detailed input based on their own experiences identifying gaps in the framework and applying real-world adaptations to the framework. However, this choice means that feedback from individuals who have not published work using the CFIR was not included. Including these individuals could potentially broaden tenets and design of the CFIR and is a direction for future research. The CFIR is part of the public commons – free and open to all – and citations of the CFIR are continuing to grow each year. Future updates will be needed, and we encourage other researchers to continue evolving the CFIR as a public good.