Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/41787
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Hayward, Kathryn S. | - |
dc.contributor.author | Dalton, Emily J. | - |
dc.contributor.author | Barth, Jessica | - |
dc.contributor.author | Brady, Marian | - |
dc.contributor.author | Cherney, Leora R. | - |
dc.contributor.author | Churilov, Leonid | - |
dc.contributor.author | Clarkson, Andrew N. | - |
dc.contributor.author | Dawson, Jesse | - |
dc.contributor.author | Dukelow, Sean P. | - |
dc.contributor.author | FEYS, Peter | - |
dc.contributor.author | Hackett, Maree | - |
dc.contributor.author | Zeiler, Steve R. | - |
dc.contributor.author | Lang, Catherine E. | - |
dc.date.accessioned | 2023-11-14T13:55:44Z | - |
dc.date.available | 2023-11-14T13:55:44Z | - |
dc.date.issued | 2023 | - |
dc.date.submitted | 2023-11-14T13:47:03Z | - |
dc.identifier.citation | International Journal of Stroke, | - |
dc.identifier.uri | http://hdl.handle.net/1942/41787 | - |
dc.description.abstract | Control comparator selection is a critical trial design issue. Preclinical and clinical investigators who are doing trials of stroke recovery and rehabilitation interventions must carefully consider the appropriateness and relevance of their chosen control comparator as the benefit of an experimental intervention is established relative to a comparator. Establishing a strong rationale for a selected comparator improves the integrity of the trial and validity of its findings. This Stroke Recovery and Rehabilitation Roundtable (SRRR) taskforce used a graph theory voting system to rank the importance and ease of addressing challenges during control comparator design. "Identifying appropriate type of control" was ranked easy to address and very important, "variability in usual care" was ranked hard to address and of low importance, and "understanding the content of the control and how it differs from the experimental intervention" was ranked very important but not easy to address. The CONtrol DeSIGN (CONSIGN) decision support tool was developed to address the identified challenges and enhance comparator selection, description, and reporting. CONSIGN is a web-based tool inclusive of seven steps that guide the user through control comparator design. The tool was refined through multiple rounds of pilot testing that included more than 130 people working in neurorehabilitation research. Four hypothetical exemplar trials, which span preclinical, mood, aphasia, and motor recovery, demonstrate how the tool can be applied in practice. Six consensus recommendations are defined that span research domains, professional disciplines, and international borders. | - |
dc.description.sponsorship | The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Receipt of financial support from the Canadian Partnership for Stroke Recovery, NHMRC Center of Research Excellence to Accelerate Stroke Trial Innovation and Translation (grant no. GNT2015705) and unrestricted educational grants provided by Ipsen Pharma and Moleac. The authors acknowledge Drs Hayward and Kwakkel for cochairing and convening the SRRRIII and Dalton for managing SRRRIII conduct and in-person meeting organization. The third international Stroke Recovery and Rehabilitation Roundtables are an initiative of the International Stroke Recovery and Rehabilitation Alliance. | - |
dc.language.iso | en | - |
dc.publisher | SAGE PUBLICATIONS LTD | - |
dc.rights | 2023 World Stroke Organization | - |
dc.subject.other | Clinical trial | - |
dc.subject.other | control | - |
dc.subject.other | preclinical | - |
dc.subject.other | stroke | - |
dc.subject.other | rehabilitation | - |
dc.subject.other | recovery | - |
dc.subject.other | consensus | - |
dc.title | Control intervention design for preclinical and clinical trials: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable | - |
dc.type | Journal Contribution | - |
local.format.pages | 11 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | Hayward, KS (corresponding author), Univ Melbourne, Dept Physiotherapy, 161 Barry St,Alan Gilbert Bldg, Carlton, Vic 3053, Australia. | - |
dc.description.notes | kate.hayward@unimelb.edu.au | - |
local.publisher.place | 1 OLIVERS YARD, 55 CITY ROAD, LONDON EC1Y 1SP, ENGLAND | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.identifier.doi | 10.1177/17474930231199336 | - |
dc.identifier.isi | 001081164700001 | - |
dc.contributor.orcid | Hayward, Kathryn/0000-0001-5240-3264; Dalton, Emily/0000-0003-3920-8530; | - |
dc.contributor.orcid | Dawson, Jesse/0000-0001-7532-2475 | - |
local.provider.type | wosris | - |
local.description.affiliation | [Hayward, Kathryn S.; Dalton, Emily J.; Churilov, Leonid] Univ Melbourne, Melbourne, Vic, Australia. | - |
local.description.affiliation | [Barth, Jessica] Providence VA Med Ctr, Providence, RI USA. | - |
local.description.affiliation | [Brady, Marian] Glasgow Caledonian Univ, Glasgow City, Scotland. | - |
local.description.affiliation | [Cherney, Leora R.] Shirley Ryan AbilityLab, Chicago, IL USA. | - |
local.description.affiliation | [Clarkson, Andrew N.] Univ Otago, Dunedin, New Zealand. | - |
local.description.affiliation | [Dawson, Jesse] Univ Glasgow, Glasgow City, Scotland. | - |
local.description.affiliation | [Dukelow, Sean P.] Univ Calgary, Calgary, AB, Canada. | - |
local.description.affiliation | [Feys, Peter] Reval Univ Hasselt, Hasselt, Belgium. | - |
local.description.affiliation | [Hackett, Maree] Univ New South Wales, Sydney, NSW, Australia. | - |
local.description.affiliation | [Zeiler, Steve R.] Johns Hopkins Univ, Baltimore, MD USA. | - |
local.description.affiliation | [Lang, Catherine E.] Washington Univ, Sch Med, St Louis, MO USA. | - |
local.description.affiliation | [Hayward, Kathryn S.] Univ Melbourne, Dept Physiotherapy, 161 Barry St,Alan Gilbert Bldg, Carlton, Vic 3053, Australia. | - |
local.uhasselt.international | yes | - |
item.accessRights | Open Access | - |
item.fullcitation | Hayward, Kathryn S.; Dalton, Emily J.; Barth, Jessica; Brady, Marian; Cherney, Leora R.; Churilov, Leonid; Clarkson, Andrew N.; Dawson, Jesse; Dukelow, Sean P.; FEYS, Peter; Hackett, Maree; Zeiler, Steve R. & Lang, Catherine E. (2023) Control intervention design for preclinical and clinical trials: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable. In: International Journal of Stroke,. | - |
item.fulltext | With Fulltext | - |
item.contributor | Hayward, Kathryn S. | - |
item.contributor | Dalton, Emily J. | - |
item.contributor | Barth, Jessica | - |
item.contributor | Brady, Marian | - |
item.contributor | Cherney, Leora R. | - |
item.contributor | Churilov, Leonid | - |
item.contributor | Clarkson, Andrew N. | - |
item.contributor | Dawson, Jesse | - |
item.contributor | Dukelow, Sean P. | - |
item.contributor | FEYS, Peter | - |
item.contributor | Hackett, Maree | - |
item.contributor | Zeiler, Steve R. | - |
item.contributor | Lang, Catherine E. | - |
crisitem.journal.issn | 1747-4930 | - |
crisitem.journal.eissn | 1747-4949 | - |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
Control intervention design for preclinical and clinical trials_ Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable.pdf | Early view | 688.42 kB | Adobe PDF | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.