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International Journal of Stroke 19(2)
Figure 1. Scatter plot of aggregated rankings of identified control comparator challenges. 0 = low importance/very hard. 5 = low
importance/very easy.
Box 2. CONSIGN tool overview.
Are you planning a preclinical or clinical trial?
Yes, continue to CONSIGN tool Step 1.
No, stop using CONSIGN tool.
Step 1: Trial information.
* Define the research question, primary and additional hypotheses if relevant, and trial purpose and phase.
Step 2: Describe your experimental intervention.
* Complete the TIDieR for the trial experimental intervention, including active and inactive ingredients.
Step 3: Consideration of control comparator options.
* Review the listed control comparator options.
* Choose all control comparator options that may address the research question.
* From options, select the preferred control comparator selection.
↻ Check if the preferred control comparator requires modification of the research question or hypothesis and amend as
needed.
Step 4: Threats to the internal validity of your control comparator.
* Consider if common threats arising from poor control comparator selection apply to the trial and consider how each
threat might impact the preferred control comparator and how each threat may be mitigated.
* Identify additional threats relevant to the control comparator selection and consider how each threat might impact the
preferred control comparator and how each threat may be mitigated.
↻ Check if any threats or their mitigation requires modification of the trial research question, hypothesis, or control
comparator selection, and amend as needed.
Step 5: Feasibility considerations.
* Identify any feasibility considerations for your preferred control comparator and how they might be mitigated.
↻ Check if any feasibility amendments require modification of the trial research question, hypothesis, or control
comparator selection, and amend as needed.
Step 6: Control / comparison reporting.
* Complete the TIDieR for your control comparator(s), including active and inactive ingredients. This is presented in
parallel to the experimental control completed in Step 2.
Step 7: CONSIGN tool completion.
* On completion, download the entire CONSIGN tool as a PDF.
↻ Return to tool to review and refine as trial planning discussions continue.
International Journal of Stroke, 19(2)

WSO - February 2024

Table of Contents for the Digital Edition of WSO - February 2024

Contents
WSO - February 2024 - Cover1
WSO - February 2024 - Cover2
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WSO - February 2024 - Contents
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WSO - February 2024 - Cover3
WSO - February 2024 - Cover4
https://europe.nxtbook.com/nxteu/sageuk/wso_202404
https://europe.nxtbook.com/nxteu/sageuk/ukstrokeforum_202402_supp
https://europe.nxtbook.com/nxteu/sageuk/wso_202403
https://europe.nxtbook.com/nxteu/sageuk/wso_202402
https://europe.nxtbook.com/nxteu/sageuk/wso_202401
https://europe.nxtbook.com/nxteu/sageuk/wso_2023123_US_UKOnly
https://europe.nxtbook.com/nxteu/sageuk/wso_2023123_ROW
https://europe.nxtbook.com/nxteu/sageuk/wso_2023101
https://europe.nxtbook.com/nxteu/sageuk/wso_202308
https://europe.nxtbook.com/nxteu/sageuk/wso_202307
https://europe.nxtbook.com/nxteu/sageuk/wso_202306
https://europe.nxtbook.com/nxteu/sageuk/wso_202304
https://europe.nxtbook.com/nxteu/sageuk/wso_202303
https://europe.nxtbook.com/nxteu/sageuk/wso_202302
https://europe.nxtbook.com/nxteu/sageuk/wso_202301
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