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Brief consent methods enable rapid enrollment in acute stroke trial: Results from the TICH-2 randomized controlled trial
Krishnan, Kailash Dineen, Robert A. Bath, Philip Sprigg, Nikola
Krishnan, Kailash
Dineen, Robert A.
Bath, Philip
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 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. REGISTRATION: URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.
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Law, Z.K., Appleton, J.P., Scutt, P., Roberts, I., Al-Shahi Salman, R., England, T.J., Werring, D.J., Robinson, T., Krishnan, K., Dineen, R.A., Laska, A.C., Lyrer, P.A., Egea-Guerrero, J.J., Karlinski, M., Christensen, H., Roffe, C., Bereczki, D., Ozturk, S., Thanabalan, J., Collins, R., Beridze, M., Ciccone, A., Duley, L., Shone, A., Bath, P. and Sprigg, N. (2022) 'Brief consent methods enable rapid enrollment in acute stroke trial: Results from the TICH-2 randomized controlled trial', Stroke, 53(4), pp. 1141-1148. doi: 10.1161/STROKEAHA.121.035191.