Understanding implementability in clinical trials : a pragmatic review and concept map

Miranda S. Cumpston; Steven A. Webb; Philippa Middleton; Greg Sharplin; Sally Green; Karen Best; Frank Bloomfield; Alan Cass; Paul Cohen; Sue Crengle; Louise Cullen; Dashiell Gantner; Heide Gaulke; Davina Ghersi; Paul Glasziou; Tiffany Harris-Brown; Stephen Jan; David Johnson; Samantha Keogh; Chris Levi; Sandra Peake; Angela Scheppokat; Paul Scuffham; Tim Shaw; David Story; Helena Teede; Val Theisz; Judith Trotman; Steve Webb; Carolina Weller; Anne Woollett; Sophia Zoungas

doi:10.1186/s13063-021-05185-w

Understanding implementability in clinical trials : a pragmatic review and concept map

Miranda S. Cumpston, Steven A. Webb, Philippa Middleton, Greg Sharplin, Sally Green, Karen Best, Frank Bloomfield, Alan Cass, Paul Cohen, Sue Crengle, Louise Cullen, Dashiell Gantner, Heide Gaulke, Davina Ghersi, Paul Glasziou, Tiffany Harris-Brown, Stephen Jan, David Johnson, Samantha Keogh, Chris LeviSandra Peake, Angela Scheppokat, Paul Scuffham, Tim Shaw, David Story, Helena Teede, Val Theisz, Judith Trotman, Steve Webb, Carolina Weller, Anne Woollett, Sophia Zoungas

Western Sydney University

Research output: Contribution to journal › Article › peer-review

Abstract

Background The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability. Methods Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019. Results Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map. Conclusions The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia.

Original language	English
Article number	232
Number of pages	10
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05185-w
Publication status	Published - 2021

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© The Author(s). 2021 Open Access 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.

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Cumpston, M. S., Webb, S. A., Middleton, P., Sharplin, G., Green, S., Best, K., Bloomfield, F., Cass, A., Cohen, P., Crengle, S., Cullen, L., Gantner, D., Gaulke, H., Ghersi, D., Glasziou, P., Harris-Brown, T., Jan, S., Johnson, D., Keogh, S., ... Zoungas, S. (2021). Understanding implementability in clinical trials : a pragmatic review and concept map. Trials, 22(1), Article 232. https://doi.org/10.1186/s13063-021-05185-w

@article{8786766bf417451c9aa672e487c83e84,

title = "Understanding implementability in clinical trials : a pragmatic review and concept map",

abstract = "Background The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability. Methods Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019. Results Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map. Conclusions The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia.",

author = "Cumpston, {Miranda S.} and Webb, {Steven A.} and Philippa Middleton and Greg Sharplin and Sally Green and Karen Best and Frank Bloomfield and Alan Cass and Paul Cohen and Sue Crengle and Louise Cullen and Dashiell Gantner and Heide Gaulke and Davina Ghersi and Paul Glasziou and Tiffany Harris-Brown and Stephen Jan and David Johnson and Samantha Keogh and Chris Levi and Sandra Peake and Angela Scheppokat and Paul Scuffham and Tim Shaw and David Story and Helena Teede and Val Theisz and Judith Trotman and Steve Webb and Carolina Weller and Anne Woollett and Sophia Zoungas",

year = "2021",

doi = "10.1186/s13063-021-05185-w",

language = "English",

volume = "22",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

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Cumpston, MS, Webb, SA, Middleton, P, Sharplin, G, Green, S, Best, K, Bloomfield, F, Cass, A, Cohen, P, Crengle, S, Cullen, L, Gantner, D, Gaulke, H, Ghersi, D, Glasziou, P, Harris-Brown, T, Jan, S, Johnson, D, Keogh, S, Levi, C, Peake, S, Scheppokat, A, Scuffham, P, Shaw, T, Story, D, Teede, H, Theisz, V, Trotman, J, Webb, S, Weller, C, Woollett, A & Zoungas, S 2021, 'Understanding implementability in clinical trials : a pragmatic review and concept map', Trials, vol. 22, no. 1, 232. https://doi.org/10.1186/s13063-021-05185-w

TY - JOUR

T1 - Understanding implementability in clinical trials : a pragmatic review and concept map

AU - Cumpston, Miranda S.

AU - Webb, Steven A.

AU - Middleton, Philippa

AU - Sharplin, Greg

AU - Green, Sally

AU - Best, Karen

AU - Bloomfield, Frank

AU - Cass, Alan

AU - Cohen, Paul

AU - Crengle, Sue

AU - Cullen, Louise

AU - Gantner, Dashiell

AU - Gaulke, Heide

AU - Ghersi, Davina

AU - Glasziou, Paul

AU - Harris-Brown, Tiffany

AU - Jan, Stephen

AU - Johnson, David

AU - Keogh, Samantha

AU - Levi, Chris

AU - Peake, Sandra

AU - Scheppokat, Angela

AU - Scuffham, Paul

AU - Shaw, Tim

AU - Story, David

AU - Teede, Helena

AU - Theisz, Val

AU - Trotman, Judith

AU - Webb, Steve

AU - Weller, Carolina

AU - Woollett, Anne

AU - Zoungas, Sophia

PY - 2021

Y1 - 2021

N2 - Background The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability. Methods Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019. Results Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map. Conclusions The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia.

AB - Background The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability. Methods Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019. Results Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map. Conclusions The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia.

UR - https://hdl.handle.net/1959.7/uws:67576

U2 - 10.1186/s13063-021-05185-w

DO - 10.1186/s13063-021-05185-w

M3 - Article

SN - 1745-6215

VL - 22

JO - Trials

JF - Trials

IS - 1

M1 - 232

ER -

Understanding implementability in clinical trials : a pragmatic review and concept map

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