TY - JOUR
T1 - Understanding implementability in clinical trials
T2 - A pragmatic review and concept map
AU - Australian Clinical Trials Alliance Reference Group on Impact and Implementation of CTN Trials
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 - Green, Sally
AU - Glasziou, Paul
AU - Harris-Brown, Tiffany
AU - Jan, Stephen
AU - Johnson, David
AU - Keogh, Samantha
AU - Levi, Chris
AU - Middleton, Philippa
AU - Peake, Sandra
AU - Scheppokat, Angela
AU - Scuffham, Paul
AU - Sharplin, Greg
AU - Shaw, Tim
AU - Story, David
AU - Teede, Helena
AU - Theisz, Val
AU - Trotman, Judith
AU - Weller, Carolina
AU - Woollett, Anne
AU - Zoungas, Sophia
N1 - Funding Information:
Funding for this project was provided by ACTA (MC, SG). ACTA received grant funding for this project from the Australian Government. Additional in-kind support for this work was received from Monash University (SG) and the Australian Government Research Training Program (MC). ACTA staff (formerly MC) and a member of the Board (SW) were involved in all aspects of the design, conduct and reporting of the study. ACTA and the Australian Government Department of Health approved the manuscript for publication.
PY - 2021/12/1
Y1 - 2021/12/1
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. Trial registration: This review did not include health-related outcomes and was therefore not eligible for registration in the PROSPERO register.
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. Trial registration: This review did not include health-related outcomes and was therefore not eligible for registration in the PROSPERO register.
KW - Applicability
KW - Clinical trials
KW - Implementability
KW - Implementation
KW - Knowledge translation
KW - Late-phase trials
KW - Pragmatic trials
UR - http://www.scopus.com/inward/record.url?scp=85103533310&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05185-w
DO - 10.1186/s13063-021-05185-w
M3 - Review article
C2 - 33771197
AN - SCOPUS:85103533310
SN - 1745-6215
VL - 22
SP - 1
EP - 10
JO - Trials
JF - Trials
IS - 1
M1 - 232
ER -