Control intervention design for preclinical and clinical trials: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable

Author:

Hayward Kathryn S1ORCID,Dalton Emily J1ORCID,Barth Jessica2,Brady Marian3ORCID,Cherney Leora R4,Churilov Leonid1,Clarkson Andrew N5,Dawson Jesse6ORCID,Dukelow Sean P7,Feys Peter8,Hackett Maree9ORCID,Zeiler Steve R10,Lang Catherine E11ORCID

Affiliation:

1. The University of Melbourne, Melbourne, VIC, Australia

2. Providence VA Medical Center, Providence, RI, USA

3. Glasgow Caledonian University, Glasgow, UK

4. Shirley Ryan AbilityLab, Chicago, IL, USA

5. University of Otago, Dunedin, New Zealand

6. University of Glasgow, Glasgow, UK

7. University of Calgary, Calgary, AB, Canada

8. Reval University of Hasselt, Hasselt, Belgium

9. University of New South Wales, Sydney, NSW, Australia

10. Johns Hopkins University, Baltimore, MD, USA

11. Washington University School of Medicine, St. Louis, MO, USA

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.

Funder

National Health and Medical Research Council

Moleac

Ipsen

Canadian Partnership for Stroke Recovery

Publisher

SAGE Publications

Subject

Neurology,Neurology (clinical)

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