Law, ZK; Appleton, JP; Scutt, P; Roberts, I; Al-Shahi Salman, R; England, TJ; Werring, DJ; ... TICH-2 Investigators; + view all Law, ZK; Appleton, JP; Scutt, P; Roberts, I; Al-Shahi Salman, R; England, TJ; Werring, DJ; Robinson, T; Krishnan, K; Dineen, RA; Laska, AC; Lyrer, PA; Egea-Guerrero, JJ; Karlinski, M; Christensen, H; Roffe, C; Bereczki, D; Ozturk, S; Thanabalan, J; Collins, R; Beridze, M; Ciccone, A; Duley, L; Shone, A; Bath, PM; Sprigg, N; TICH-2 Investigators; - view fewer (2022) Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial. Stroke 10.1161/STROKEAHA.121.035191. (In press).

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Abstract

BACKGROUND AND PURPOSE: 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. Registration: URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.

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