Foy, R. orcid.org/0000-0003-0605-7713, Ivers, N.M., Grimshaw, J.M. et al. (1 more author) (2023) What is the role of randomised trials in implementation science? Trials, 24 (1). 537. ISSN 1745-6215
Abstract
Background There is a consistent demand for implementation science to inform global efforts to close the gap between evidence and practice. Key evaluation questions for any given implementation strategy concern the assessment and understanding of effects. Randomised trials are generally accepted as offering the most trustworthy design for establishing effectiveness but may be underused in implementation science.
Main body There is a continuing debate about the primacy of the place of randomised trials in evaluating implementation strategies, especially given the evolution of more rigorous quasi-experimental designs. Further critiques of trials for implementation science highlight that they cannot provide ‘real world’ evidence, address urgent and important questions, explain complex interventions nor understand contextual influences. We respond to these critiques of trials and highlight opportunities to enhance their timeliness and relevance through innovative designs, embedding within large-scale improvement programmes and harnessing routine data.
Our suggestions for optimising the conditions for randomised trials of implementation strategies include strengthening partnerships with policy-makers and clinical leaders to realise the long-term value of rigorous evaluation and accelerating ethical approvals and decluttering governance procedures for lower risk studies.
Conclusion Policy-makers and researchers should avoid prematurely discarding trial designs when evaluating implementation strategies and work to enhance the conditions for their conduct.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s) 2023. This 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. |
Keywords: | Cluster randomised controlled trials; Implementation science; Quality improvement |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Health Sciences (Leeds) > Academic Unit of Primary Care (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 17 Apr 2024 10:42 |
Last Modified: | 17 Apr 2024 10:42 |
Published Version: | http://dx.doi.org/10.1186/s13063-023-07578-5 |
Status: | Published |
Publisher: | Springer Science and Business Media LLC |
Identification Number: | 10.1186/s13063-023-07578-5 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:207020 |