Zhe Kang Law1,2, Jason P Appleton1,3, Polly Scutt1, Ian Roberts4, Rustam Al-Shahi Salman5, Timothy J England6, David J Werring7, Thompson Robinson8, Kailash Krishnan9, Robert A Dineen10,11, Ann Charlotte Laska12, Philippe A Lyrer13, Juan Jose Egea-Guerrero14, Michal Karlinski15, Hanne Christensen16, Christine Roffe17, Daniel Bereczki18, Serefnur Ozturk19, Jegan Thanabalan20, Ronan Collins21, Maia Beridze22, Alfonso Ciccone23, Lelia Duley24, Angela Shone25, Philip M Bath1,9, Nikola Sprigg1,9. 1. Stroke Trials Unit (Z.K.L., J.P.A., P.S., P.M.B., N.S.), University of Nottingham, United Kingdom. 2. Department of Medicine (Z.K.L.), National University of Malaysia. 3. Stroke, University Hospitals Birmingham NHS Foundation Trust, United Kingdom (J.P.A.). 4. Clinical Trials Unit, London School of Hygiene and Tropical Medicine, United Kingdom (I.R.). 5. Centre for Clinical Brain Sciences, University of Edinburgh, United Kingdom (R.A.-S.S.). 6. Vascular Medicine, Division of Medical Sciences and GEM, Royal Derby Hospital Centre (T.J.E.), University of Nottingham, United Kingdom. 7. Stroke Research Centre, UCL Queen Square Institute of Neurology, London, United Kingdom (D.J.W.). 8. Department of Cardiovascular Sciences and NIHR Biomedical Research Centre, University of Leicester, United Kingdom (T.R.). 9. Stroke, Nottingham University Hospitals NHS Trust, United Kingdom (K.K., P.M.B., N.S.). 10. Radiological Sciences (R.A.D.), University of Nottingham, United Kingdom. 11. NIHR Nottingham Biomedical Research Centre, United Kingdom (R.A.D.). 12. Department of Clinical Sciences, Karolinska Institute Danderyd Hospital, Sweden (A.C.L.). 13. Department of Neurology and Stroke Center, University Hospital Basel and University of Basel, Switzerland (P.A.L.). 14. NeuroCritical Care Unit, Virgen del Rocio University Hospital, Seville, Spain (J.J.E.-G.). 15. Institute of Psychiatry and Neurology, Warsaw, Poland (M.K.). 16. Department of Neurology, Bispebjerg Hospital and University of Copenhagen, Denmark (H.C.). 17. Stroke Research, School of Medicine, Keele University, Newcastle-Under-Lyme, United Kingdom (C.R.). 18. Department of Neurology, Semmelweis University, Budapest, Hungary (D.B.). 19. Selcuk University Faculty of Medicine, Department of Neurology, Konya, Turkey (S.O.). 20. Department of Surgery, Division of Neurosurgery (J.T.), National University of Malaysia. 21. Age Related Health Care/Stroke-Service, Tallaght University Hospital, Dublin, Republic of Ireland (R.C.). 22. The First University Clinic of Tbilisi State Medical University, GA (M.B.). 23. Neurology and Stroke Unit, Poma Hospital, ASST di Mantova, Mantua, Italy (A.C.). 24. Nottingham Clinical Trials Unit (L.D.), University of Nottingham, United Kingdom. 25. Research and Innovation (A.S.), University of Nottingham, United Kingdom.
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 ≤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.
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. REGISTRATION: URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.
Entities:
Keywords:
cerebral hemorrhage; humans; informed consent; logistic models; lost to follow-up; tranexamic acid
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