Fulltext

Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial

Law ZK 1 , Appleton JP 1 , Scutt P 1 , Roberts I 2 , Al-Shahi Salman R 3 , England TJ 4 Show all authors , Werring DJ 5 , Robinson T 6 , Krishnan K 7 , Dineen RA 8 , Laska AC 9 , Lyrer PA 10 , Egea-Guerrero JJ 11 , Karlinski M 12 , Christensen H 13 , Roffe C 14 , Bereczki D 15 , Ozturk S 16 , Thanabalan J 17 , Collins R 18 , Beridze M 19 , Ciccone A 20 , Duley L 21 , Shone A 22 , Bath PM 1 , Sprigg N 1 , TICH-2 Investigators

Affiliations 

  • 1 Stroke Trials Unit (Z.K.L., J.P.A., P.S., P.M.B., N.S.), University of Nottingham, United Kingdom
  • 2 Clinical Trials Unit, London School of Hygiene and Tropical Medicine, United Kingdom (I.R.)
  • 3 Centre for Clinical Brain Sciences, University of Edinburgh, United Kingdom (R.A.-S.S.)
  • 4 Vascular Medicine, Division of Medical Sciences and GEM, Royal Derby Hospital Centre (T.J.E.), University of Nottingham, United Kingdom
  • 5 Stroke Research Centre, UCL Queen Square Institute of Neurology, London, United Kingdom (D.J.W.)
  • 6 Department of Cardiovascular Sciences and NIHR Biomedical Research Centre, University of Leicester, United Kingdom (T.R.)
  • 7 Stroke, Nottingham University Hospitals NHS Trust, United Kingdom (K.K., P.M.B., N.S.)
  • 8 Radiological Sciences (R.A.D.), University of Nottingham, United Kingdom
  • 9 Department of Clinical Sciences, Karolinska Institute Danderyd Hospital, Sweden (A.C.L.)
  • 10 Department of Neurology and Stroke Center, University Hospital Basel and University of Basel, Switzerland (P.A.L.)
  • 11 NeuroCritical Care Unit, Virgen del Rocio University Hospital, Seville, Spain (J.J.E.-G.)
  • 12 Institute of Psychiatry and Neurology, Warsaw, Poland (M.K.)
  • 13 Department of Neurology, Bispebjerg Hospital and University of Copenhagen, Denmark (H.C.)
  • 14 Stroke Research, School of Medicine, Keele University, Newcastle-Under-Lyme, United Kingdom (C.R.)
  • 15 Department of Neurology, Semmelweis University, Budapest, Hungary (D.B.)
  • 16 Selcuk University Faculty of Medicine, Department of Neurology, Konya, Turkey (S.O.)
  • 17 Department of Surgery, Division of Neurosurgery (J.T.), National University of Malaysia
  • 18 Age Related Health Care/Stroke-Service, Tallaght University Hospital, Dublin, Republic of Ireland (R.C.)
  • 19 The First University Clinic of Tbilisi State Medical University, GA (M.B.)
  • 20 Neurology and Stroke Unit, Poma Hospital, ASST di Mantova, Mantua, Italy (A.C.)
  • 21 Nottingham Clinical Trials Unit (L.D.), University of Nottingham, United Kingdom
  • 22 Research and Innovation (A.S.), University of Nottingham, United Kingdom
Stroke, 2022 Apr;53(4):1141-1148.
PMID: 34847710 DOI: 10.1161/STROKEAHA.121.035191

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

MeSH terms
Similar publications