Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial
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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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Stroke |
| Vol/bind | 53 |
| Udgave nummer | 4 |
| Sider (fra-til) | 1141-1148 |
| ISSN | 0039-2499 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
P.M. Bath is Stroke Association Professor of Stroke Medicine and a National Institute for Health Research (NIHR) Senior Investigator. He has received consulting fees from DiaMedica, Moleac, Nestle, Phagenesis, and Sanofi; he is an unpaid advisor to Platelet Solutions. Dr Robinson is an NIHR Senior Investigator. R. Collins has accepted speaker’s honoraria from Bayer, Daichii Sankyo, and Pfizer. Dr Werring has received honoraria from Bayer, Alnylam, Portola, and NovNordisk. Dr Al-Shahi Salman has received grants from NIHR during the conduct of the study and grants from the British Heart Foundation outside the submitted work. Dr Appleton, Dr Dineen, N. Sprigg, Dr Roffe, and Dr England report grants from NIHR Health Technology Assessment during the conduct of the study. Dr Lyrer has received advisory board compensation from Bayer, Switzerland; nonfinancial support, advisory board compensation, and travel grant from Boehringer Ingelheim; advisory board compensation and travel grant from Pfizer; research grants from University Hospital Basel, Neurology Clinic; research grants from the Swiss National Foundation SNF; research grants from ACTICOR France; advisory board compensation from Biogen, Switzerland; investigator fees from Alexion; and grants from Bayer, Germany, outside the submitted work. Dr Karlinski has received personal fees from Boehringer Ingelheim, Pfizer, Bayer, and Medtronic outside the submitted work. H. Christensen has received national lead fees to institutional research account from Bayer and Portola and personal fees from Bristol Myers Squibb and Bayer outside the submitted work. L. Duley was the chief investigator of a perinatal trial, which developed a similar brief consent process. This was adapted for use in acute stroke, as reported in the current study.
Funding Information:
TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (NIHR HTA project code 11_129_109).
Publisher Copyright:
© 2022 American Heart Association, Inc.
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