Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial

the TICH-2 Investigators; Law, Zhe Kang; Appleton, Jason P.; Scutt, Polly; Roberts, Ian; Al-Shahi Salman, Rustam; England, Timothy J.; Werring, David J.; Robinson, Thompson; Krishnan, Kailash; Dineen, Robert A.; Laska, Ann Charlotte; Lyrer, Philippe A.; Egea-Guerrero, Juan Jose; Karlinski, Michal; Christensen, Hanne; Roffe, Christine; Bereczki, Daniel; Ozturk, Serefnur; Thanabalan, Jegan; Collins, Ronan; Beridze, Maia; Ciccone, Alfonso; Duley, Lelia; Shone, Angela; Bath, Philip M.; Sprigg, Nikola

Abstract

Background: Seeking consent rapidly in acute stroke trials is crucial as interventions are time sensitive. We explored the association between consent pathways and time to enrollment in the TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) randomized controlled trial. Methods: Consent was provided by patients or by a relative or an independent doctor in incapacitated patients, using a 1-stage (full written consent) or 2-stage (initial brief consent followed by full written consent post-randomization) approach. The computed tomography-to-randomization time according to consent pathways was compared using the Kruskal-Wallis test. Multivariable logistic regression was performed to identify variables associated with onset-to-randomization time of ≤3 hours. Results: Of 2325 patients, 817 (35%) gave self-consent using 1-stage (557; 68%) or 2-stage consent (260; 32%). For 1507 (65%), consent was provided by a relative (1 stage, 996 [66%]; 2 stage, 323 [21%]) or a doctor (all 2-stage, 188 [12%]). One patient did not record prerandomization consent, with written consent obtained subsequently. The median (interquartile range) computed tomography-to-randomization time was 55 (38-93) minutes for doctor consent, 55 (37-95) minutes for 2-stage patient, 69 (43-110) minutes for 2-stage relative, 75 (48-124) minutes for 1-stage patient, and 90 (56-155) minutes for 1-stage relative consents (P<0.001). Two-stage consent was associated with onset-to-randomization time of ≤3 hours compared with 1-stage consent (adjusted odds ratio, 1.9 [95% CI, 1.5-2.4]). Doctor consent increased the odds (adjusted odds ratio, 2.3 [1.5-3.5]) while relative consent reduced the odds of randomization ≤3 hours (adjusted odds ratio, 0.10 [0.03-0.34]) compared with patient consent. Only 2 of 771 patients (0.3%) in the 2-stage pathways withdrew consent when full consent was sought later. Two-stage consent process did not result in higher withdrawal rates or loss to follow-up. Conclusions: The use of initial brief consent was associated with shorter times to enrollment, while maintaining good participant retention. Seeking written consent from relatives was associated with significant delays.

Citation

the TICH-2 Investigators, Law, Z. K., Appleton, J. P., Scutt, P., Roberts, I., Al-Shahi Salman, R., …Sprigg, N. (2021). Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial. Stroke, 53(4), 1141-1148. https://doi.org/10.1161/STROKEAHA.121.035191

• Journal Article Type: Article
• Acceptance Date: Oct 6, 2021
• Online Publication Date: Dec 1, 2021
• Publication Date: Dec 1, 2021
• Deposit Date: Nov 23, 2021
• Publicly Available Date: Jun 2, 2022
• Journal: Stroke
• Print ISSN: 0039-2499
• Electronic ISSN: 1524-4628
• Publisher: Ovid Technologies (Wolters Kluwer Health)
• Peer Reviewed: Peer Reviewed
• Volume: 53
• Issue: 4
• Pages: 1141-1148
• DOI: https://doi.org/10.1161/STROKEAHA.121.035191
• Keywords: Advanced and Specialised Nursing; Cardiology and Cardiovascular Medicine; Clinical Neurology
• Public URL: https://nottingham-repository.worktribe.com/output/6784157
• Publisher URL: https://www.ahajournals.org/doi/10.1161/STROKEAHA.121.035191