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      The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions

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          Abstract

          Background

          This paper describes the process and results of a refinement of a framework to characterize modifications to interventions. The original version did not fully capture several aspects of modification and adaptation that may be important to document and report. Additionally, the earlier framework did not include a way to differentiate cultural adaptation from adaptations made for other reasons. Reporting additional elements will allow for a more precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.

          Discussion

          We employed a multifaceted approach to develop the updated FRAME involving coding documents identified through a literature review, rapid coding of qualitative interviews, and a refinement process informed by multiple stakeholders. The updated FRAME expands upon Stirman et al.’s original framework by adding components of modification to report: (1) when and how in the implementation process the modification was made, (2) whether the modification was planned/proactive (i.e., an adaptation) or unplanned/reactive, (3) who determined that the modification should be made, (4) what is modified, (5) at what level of delivery the modification is made, (6) type or nature of context or content-level modifications, (7) the extent to which the modification is fidelity-consistent, and (8) the reasons for the modification, including (a) the intent or goal of the modification (e.g., to reduce costs) and (b) contextual factors that influenced the decision. Methods of using the framework to assess modifications are outlined, along with their strengths and weaknesses, and considerations for research to validate these measurement strategies.

          Conclusion

          The updated FRAME includes consideration of when and how modifications occurred, whether it was planned or unplanned, relationship to fidelity, and reasons and goals for modification. This tool that can be used to support research on the timing, nature, goals and reasons for, and impact of modifications to evidence-based interventions.

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          Most cited references60

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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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            The Social Determinants of Health: It's Time to Consider the Causes of the Causes

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              Implementation strategies: recommendations for specifying and reporting

              Implementation strategies have unparalleled importance in implementation science, as they constitute the ‘how to’ component of changing healthcare practice. Yet, implementation researchers and other stakeholders are not able to fully utilize the findings of studies focusing on implementation strategies because they are often inconsistently labelled and poorly described, are rarely justified theoretically, lack operational definitions or manuals to guide their use, and are part of ‘packaged’ approaches whose specific elements are poorly understood. We address the challenges of specifying and reporting implementation strategies encountered by researchers who design, conduct, and report research on implementation strategies. Specifically, we propose 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. Ultimately, implementation strategies cannot be used in practice or tested in research without a full description of their components and how they should be used. As with all intervention research, their descriptions must be precise enough to enable measurement and ‘reproducibility.’ We propose these recommendations to improve the reporting of implementation strategies in research studies and to stimulate further identification of elements pertinent to implementation strategies that should be included in reporting guidelines for implementation strategies.
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                Author and article information

                Contributors
                sws1@stanford.edu
                abaumann@gwbmail.wustl.edu
                Christopher.Miller8@va.gov
                Journal
                Implement Sci
                Implement Sci
                Implementation Science : IS
                BioMed Central (London )
                1748-5908
                6 June 2019
                6 June 2019
                2019
                : 14
                : 58
                Affiliations
                [1 ]ISNI 0000000419368956, GRID grid.168010.e, National Center for PTSD and Stanford University, ; 795 Willow Road NC-PTSD, Menlo Park, CA 94025 USA
                [2 ]ISNI 0000 0001 2355 7002, GRID grid.4367.6, Washington University in St. Louis, ; One Brookings Drive, St. Louis, MO 63130 USA
                [3 ]ISNI 0000 0004 4657 1992, GRID grid.410370.1, Center for Healthcare Organization and Implementation Research (CHOIR),VA Boston Healthcare System, ; Boston, MA 02130 USA
                [4 ]ISNI 000000041936754X, GRID grid.38142.3c, Harvard Medical School Department of Psychiatry, ; Boston, MA 02115 USA
                Author information
                http://orcid.org/0000-0001-9917-5078
                Article
                898
                10.1186/s13012-019-0898-y
                6554895
                31171014
                b6d3a416-85ab-48f0-809c-2a8d728043ba
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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.

                History
                : 19 November 2018
                : 22 April 2019
                Funding
                Funded by: National Institute of Mental Health
                Award ID: R01 MH 106506
                Funded by: FundRef http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award ID: U01HL133994-03S
                Funded by: FundRef http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award ID: UL1TR00234
                Funded by: National Institute of Mental Health (US)
                Award ID: R01HG009351
                Funded by: FundRef http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award ID: U24HL136790-02
                Funded by: FundRef http://dx.doi.org/10.13039/100007181, Quality Enhancement Research Initiative;
                Award ID: QUE 15-289
                Funded by: FundRef http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award ID: 5R25MH08091607
                Categories
                Debate
                Custom metadata
                © The Author(s) 2019

                Medicine
                modification,adaptation,cultural adaptation,implementation outcomes
                Medicine
                modification, adaptation, cultural adaptation, implementation outcomes

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