RT Journal Article
T1 Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial.
A1 Law, Zhe Kang
A1 Appleton, Jason P
A1 Scutt, Polly
A1 Roberts, Ian
A1 Al-Shahi Salman, Rustam
A1 England, Timothy J
A1 Werring, David J
A1 Robinson, Thompson
A1 Krishnan, Kailash
A1 Dineen, Robert A
A1 Laska, Ann Charlotte
A1 Lyrer, Philippe A
A1 Egea-Guerrero, Juan Jose
A1 Karlinski, Michal
A1 Christensen, Hanne
A1 Roffe, Christine
A1 Bereczki, Daniel
A1 Ozturk, Serefnur
A1 Thanabalan, Jegan
A1 Collins, Ronan
A1 Beridze, Maia
A1 Ciccone, Alfonso
A1 Duley, Lelia
A1 Shone, Angela
A1 Bath, Philip M
A1 Sprigg, Nikola
A1 TICH-2 Investigators, 
K1 cerebral hemorrhage
K1 humans
K1 informed consent
K1 logistic models
K1 lost to follow-up
K1 tranexamic acid
AB 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. 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. 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 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. URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.
YR 2021
FD 2021-12-01
LK http://hdl.handle.net/10668/20202
UL http://hdl.handle.net/10668/20202
LA en
DS RISalud
RD Apr 17, 2025