Evidence map›Paper›PMID 34847710›Full record

Trial reportStroke2022

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

Zhe Kang Law, Jason P Appleton, Polly Scutt, Ian Roberts, Rustam Al-Shahi Salman, Timothy J England, David J Werring, Thompson Robinson, Kailash Krishnan, Robert A Dineen and 17 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Stroke, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 20 institutions in 12 countries.

Zhe Kang LawStroke Trials Unit (Z.K.L., J.P.A., P.S., P.M.B., N.S.), University of Nottingham, United Kingdom.ORCID 0000-0002-7900-9037
Jason P AppletonStroke Trials Unit (Z.K.L., J.P.A., P.S., P.M.B., N.S.), University of Nottingham, United Kingdom.
Polly ScuttStroke Trials Unit (Z.K.L., J.P.A., P.S., P.M.B., N.S.), University of Nottingham, United Kingdom.
Ian RobertsClinical Trials Unit, London School of Hygiene and Tropical Medicine, United Kingdom (I.R.).
Rustam Al-Shahi SalmanCentre for Clinical Brain Sciences, University of Edinburgh, United Kingdom (R.A.-S.S.).
Timothy J EnglandVascular Medicine, Division of Medical Sciences and GEM, Royal Derby Hospital Centre (T.J.E.), University of Nottingham, United Kingdom.ORCID 0000-0001-5330-8584
David J WerringStroke Research Centre, UCL Queen Square Institute of Neurology, London, United Kingdom (D.J.W.).
Thompson RobinsonDepartment of Cardiovascular Sciences and NIHR Biomedical Research Centre, University of Leicester, United Kingdom (T.R.).
Kailash KrishnanStroke, Nottingham University Hospitals NHS Trust, United Kingdom (K.K., P.M.B., N.S.).ORCID 0000-0002-6486-3783
Robert A DineenRadiological Sciences (R.A.D.), University of Nottingham, United Kingdom.ORCID 0000-0002-9523-2546
Ann Charlotte LaskaDepartment of Clinical Sciences, Karolinska Institute Danderyd Hospital, Sweden (A.C.L.).
Philippe A LyrerDepartment of Neurology and Stroke Center, University Hospital Basel and University of Basel, Switzerland (P.A.L.).
Juan Jose Egea-GuerreroNeuroCritical Care Unit, Virgen del Rocio University Hospital, Seville, Spain (J.J.E.-G.).ORCID 0000-0002-4166-313X
Michal KarlinskiInstitute of Psychiatry and Neurology, Warsaw, Poland (M.K.).
Hanne ChristensenDepartment of Neurology, Bispebjerg Hospital and University of Copenhagen, Denmark (H.C.).
Christine RoffeStroke Research, School of Medicine, Keele University, Newcastle-Under-Lyme, United Kingdom (C.R.).ORCID 0000-0002-5259-6649
Daniel BereczkiDepartment of Neurology, Semmelweis University, Budapest, Hungary (D.B.).ORCID 0000-0002-8374-0500
Serefnur OzturkSelcuk University Faculty of Medicine, Department of Neurology, Konya, Turkey (S.O.).ORCID 0000-0001-8986-155X
Jegan ThanabalanDepartment of Surgery, Division of Neurosurgery (J.T.), National University of Malaysia.ORCID 0000-0001-9790-7191
Ronan CollinsAge Related Health Care/Stroke-Service, Tallaght University Hospital, Dublin, Republic of Ireland (R.C.).
Maia BeridzeThe First University Clinic of Tbilisi State Medical University, GA (M.B.).
Alfonso CicconeNeurology and Stroke Unit, Poma Hospital, ASST di Mantova, Mantua, Italy (A.C.).
Lelia DuleyNottingham Clinical Trials Unit (L.D.), University of Nottingham, United Kingdom.ORCID 0000-0001-6721-5178
Angela ShoneResearch and Innovation (A.S.), University of Nottingham, United Kingdom.ORCID 0000-0001-8834-7938
Philip M BathStroke Trials Unit (Z.K.L., J.P.A., P.S., P.M.B., N.S.), University of Nottingham, United Kingdom.
Nikola SpriggStroke Trials Unit (Z.K.L., J.P.A., P.S., P.M.B., N.S.), University of Nottingham, United Kingdom.
TICH-2 Investigators
University of Nottingham · GBNottingham University Hospitals NHS Trust · GBAzienda Ospedaliera Carlo Poma · ITBispebjerg Hospital · DKHospital Universitario Virgen del Rocío · ESInstitute of Psychiatry and Neurology · PLKarolinska Institutet · SEKeele University · GBNational Stroke Association of Malaysia · MYNIHR Leicester Cardiovascular Biomedical Research Unit · GBQueen Mary University of London · GBRoyal Derby Hospital · GBSelçuk University · TRSemmelweis University · HUTallaght University Hospital · IETbilisi State Medical University · GEUniversity Hospital of Basel · CHUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity of Edinburgh · GBUniversity of London · GB

Funding

British Heart Foundation CS/18/2/33719British Heart Foundation SP/12/2/29422Department of Health 11_129_109Medical Research Council G1002605Medical Research Council G108/613
6 · The paper itself

Abstract

backgroundSeeking 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.

methodsConsent 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.

resultsOf 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 (

conclusionsThe 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.

Indexed as

StrokeTranexamic AcidCerebral HemorrhageHumansInformed ConsentLogistic ModelsTreatment OutcomeTranexamic Acidcerebral hemorrhagehumansinformed consentlogistic modelslost to follow-uptranexamic acid

Identifiers

PMID34847710
PMCPMC7612544
OpenAlexW3215440932

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.