The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review

Abstract Background The uptake, adoption and integration of new medicines and treatment regimens within healthcare delivery can take a decade or more. Increasingly, implementation science (IS) research is being used to bridge this gap between the availability of new therapeutic evidence and its actu...

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Main Authors: Meredith Y. Smith, Bridget Gaglio, Milena Anatchkova
Format: Article
Language:English
Published: BMC 2024-01-01
Series:Health Research Policy and Systems
Subjects:
Online Access:https://doi.org/10.1186/s12961-024-01102-0
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author Meredith Y. Smith
Bridget Gaglio
Milena Anatchkova
author_facet Meredith Y. Smith
Bridget Gaglio
Milena Anatchkova
author_sort Meredith Y. Smith
collection DOAJ
description Abstract Background The uptake, adoption and integration of new medicines and treatment regimens within healthcare delivery can take a decade or more. Increasingly, implementation science (IS) research is being used to bridge this gap between the availability of new therapeutic evidence and its actual application in clinical practice. Little is known, however, about the quality of IS research in this area, including the degree to which theories, models and frameworks (TMFs) are being used. The objective of this study was to conduct a scoping review of the use of TMFs in implementation research involving medicinal products. Methods A search was conducted for English language abstracts and manuscripts describing the application of TMFs in IS studies for medicinal products. Eligible publications were those published between 1 January 1974 and 12 December 2022. All records were screened at the title and abstract stage; included full-text papers were abstracted using data extraction tables designed for the study. Study quality was appraised using the Implementation Research Development Tool. Results The initial scoping search identified 2697 publications, of which 9 were ultimately eligible for inclusion in the review. Most studies were published after 2020 and varied in their objectives, design and therapeutic area. Most studies had sample sizes of fewer than 50 participants, and all focused on the post-marketing phase of drug development. The TMF most frequently used was the Consolidated Framework for Implementation Research (CFIR). Although most studies applied all TMF domains, TMF use was limited to instrument development and/or qualitative analysis. Quality appraisals indicated the need for engaging patients and other stakeholders in the implementation research, reporting on the cost of implementation strategies, and evaluating the unintended consequences of implementation efforts. Conclusions We found that few IS studies involving medicinal products reported using TMFs. Those that did encompassed a wide variety of therapeutic indications and medicinal products; all were in the post-marketing phase and involved limited application of the TMFs. Researchers should consider conducting IS in earlier phases of drug development and integrating the TMFs throughout the research process. More consistent and in-depth use of TMFs may help advance research in this area.
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spelling doaj.art-994a585e520c4a52b7f3c54c0a48cc332024-03-05T20:44:38ZengBMCHealth Research Policy and Systems1478-45052024-01-0122111910.1186/s12961-024-01102-0The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping reviewMeredith Y. Smith0Bridget Gaglio1Milena Anatchkova2Evidera, Inc.Evidera, Inc.Evidera, Inc.Abstract Background The uptake, adoption and integration of new medicines and treatment regimens within healthcare delivery can take a decade or more. Increasingly, implementation science (IS) research is being used to bridge this gap between the availability of new therapeutic evidence and its actual application in clinical practice. Little is known, however, about the quality of IS research in this area, including the degree to which theories, models and frameworks (TMFs) are being used. The objective of this study was to conduct a scoping review of the use of TMFs in implementation research involving medicinal products. Methods A search was conducted for English language abstracts and manuscripts describing the application of TMFs in IS studies for medicinal products. Eligible publications were those published between 1 January 1974 and 12 December 2022. All records were screened at the title and abstract stage; included full-text papers were abstracted using data extraction tables designed for the study. Study quality was appraised using the Implementation Research Development Tool. Results The initial scoping search identified 2697 publications, of which 9 were ultimately eligible for inclusion in the review. Most studies were published after 2020 and varied in their objectives, design and therapeutic area. Most studies had sample sizes of fewer than 50 participants, and all focused on the post-marketing phase of drug development. The TMF most frequently used was the Consolidated Framework for Implementation Research (CFIR). Although most studies applied all TMF domains, TMF use was limited to instrument development and/or qualitative analysis. Quality appraisals indicated the need for engaging patients and other stakeholders in the implementation research, reporting on the cost of implementation strategies, and evaluating the unintended consequences of implementation efforts. Conclusions We found that few IS studies involving medicinal products reported using TMFs. Those that did encompassed a wide variety of therapeutic indications and medicinal products; all were in the post-marketing phase and involved limited application of the TMFs. Researchers should consider conducting IS in earlier phases of drug development and integrating the TMFs throughout the research process. More consistent and in-depth use of TMFs may help advance research in this area.https://doi.org/10.1186/s12961-024-01102-0Implementation scienceDisseminationKnowledge translationPharmaceuticalsDrug developmentTheories
spellingShingle Meredith Y. Smith
Bridget Gaglio
Milena Anatchkova
The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review
Health Research Policy and Systems
Implementation science
Dissemination
Knowledge translation
Pharmaceuticals
Drug development
Theories
title The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review
title_full The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review
title_fullStr The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review
title_full_unstemmed The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review
title_short The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review
title_sort use of implementation science theories models and frameworks in implementation research for medicinal products a scoping review
topic Implementation science
Dissemination
Knowledge translation
Pharmaceuticals
Drug development
Theories
url https://doi.org/10.1186/s12961-024-01102-0
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