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      Conceptualizing outcomes for use with the Consolidated Framework for Implementation Research (CFIR): the CFIR Outcomes Addendum

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          Abstract

          Background

          The challenges of implementing evidence-based innovations (EBIs) are widely recognized among practitioners and researchers. Context, broadly defined as everything outside the EBI, includes the dynamic and diverse array of forces working for or against implementation efforts. The Consolidated Framework for Implementation Research (CFIR) is one of the most widely used frameworks to guide assessment of contextual determinants of implementation. The original 2009 article invited critique in recognition for the need for the framework to evolve. As implementation science has matured, gaps in the CFIR have been identified and updates are needed. Our team is developing the CFIR 2.0 based on a literature review and follow-up survey with authors. We propose an Outcomes Addendum to the CFIR to address recommendations from these sources to include outcomes in the framework.

          Main text

          We conducted a literature review and surveyed corresponding authors of included articles to identify recommendations for the CFIR. There were recommendations to add both implementation and innovation outcomes from these sources. Based on these recommendations, we make conceptual distinctions between (1) anticipated implementation outcomes and actual implementation outcomes, (2) implementation outcomes and innovation outcomes, and (3) CFIR-based implementation determinants and innovation determinants.

          Conclusion

          An Outcomes Addendum to the CFIR is proposed. Our goal is to offer clear conceptual distinctions between types of outcomes for use with the CFIR, and perhaps other determinant implementation frameworks as well. These distinctions can help bring clarity as researchers consider which outcomes are most appropriate to evaluate in their research. We hope that sharing this in advance will generate feedback and debate about the merits of our proposed addendum.

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          Most cited references62

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          Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science

          Background Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts. Methods We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts. Results The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct. Conclusion The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.
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            Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda

            An unresolved issue in the field of implementation research is how to conceptualize and evaluate successful implementation. This paper advances the concept of “implementation outcomes” distinct from service system and clinical treatment outcomes. This paper proposes a heuristic, working “taxonomy” of eight conceptually distinct implementation outcomes—acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability—along with their nominal definitions. We propose a two-pronged agenda for research on implementation outcomes. Conceptualizing and measuring implementation outcomes will advance understanding of implementation processes, enhance efficiency in implementation research, and pave the way for studies of the comparative effectiveness of implementation strategies.
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              Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact.

              This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.
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                Author and article information

                Contributors
                Laura.Damschroder@va.gov
                Journal
                Implement Sci
                Implement Sci
                Implementation Science : IS
                BioMed Central (London )
                1748-5908
                22 January 2022
                22 January 2022
                2022
                : 17
                : 7
                Affiliations
                GRID grid.413800.e, ISNI 0000 0004 0419 7525, VA Center for Clinical Management Research, , VA Ann Arbor Healthcare System, ; 2215 Fuller Road, Ann Arbor, MI 48105 USA
                Author information
                http://orcid.org/0000-0002-3657-8459
                Article
                1181
                10.1186/s13012-021-01181-5
                8783408
                35065675
                96bdaa7a-aeba-480a-8e26-37ede1b08925
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 23 August 2021
                : 14 December 2021
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100007181, Quality Enhancement Research Initiative;
                Award ID: QUE 15-286
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100007217, Health Services Research and Development;
                Award ID: LIP 20-116
                Categories
                Debate
                Custom metadata
                © The Author(s) 2022

                Medicine
                implementation science,antecedent assessments,implementation outcomes,anticipated outcomes,actual outcomes,innovation outcomes,implementation framework,evaluation methods,theory,consolidated framework for implementation research

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