Brief consent methods enable rapid enrollment in acute stroke trial: results from the TICH-2 randomized controlled trial.
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
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
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2021-12-01
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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.
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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. Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial. Stroke. 2022 Apr;53(4):1141-1148. doi: 10.1161/STROKEAHA.121.035191. Epub 2021 Dec 1.
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