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Recruitment challenges in MRI studies of acute intracerebral haemorrhage: experience from the TICH-2 MRI substudy

Pszczolkowski, Stefan; Bath, Philip M.W.; Sprigg, Nikola; Dineen, Robert A.

Authors

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine

NIKOLA SPRIGG nikola.sprigg@nottingham.ac.uk
Professor of Stroke Medicine



Abstract

BACKGROUND AND AIMS
Magnetic Resonance Imaging (MRI) is widely used in clinical practice and in trials for ischaemic stroke; however, relatively few large multicentre trials for intracerebral haemorrhage have used MRI. We describe the main recruitment challenges faced in the TICH-2 MRI substudy, which is nested within TICH-2, a multi-centre randomised placebo-controlled trial of tranexamic acid in intracerebral haemorrhage (ISRCTN93732214).
METHOD
TICH-2 participants at recruiting centres were eligible for the substudy. Centres were asked to record, if applicable, the reason for non-recruitment. The recruitment window was day 2 to day 14 post-randomisation.
RESULTS
Figure 1 shows the distribution of reasons for non-recruitment (N=169). Clinical instability was the main reason for non-recruitment, accounting for 34.3% of the cases. The mean NIHSS scores (as per TICH-2 protocol) for unrecruited patients classified as clinically unstable were 19 (range 5-32,N=57), 21 (range 0-40,N=51) and 20 (range 1-38,N=37) for baseline, day 2 and day 7 post-randomisation, respectively. In contrast, for recruited patients (N=142) the mean scores were 10 (range 0-28,N=141), 8 (range 0-26,N=139) and 8 (range 0-31,N=132). Other important factors for non-recruitment include difficulty obtaining consent, patient refusal, claustrophobia and transfer to other hospitals.
CONCLUSION
Clinical instability in intracerebral haemorrhage poses a challenge for recruitment into MRI studies. This, and other factors, should be taken into consideration when designing clinical trials of intracerebral haemorrhage involving MRI.

Start Date May 16, 2018
Publication Date May 16, 2018
Peer Reviewed Peer Reviewed
APA6 Citation Pszczolkowski, S., Bath, P. M., Sprigg, N., & Dineen, R. A. (2018). Recruitment challenges in MRI studies of acute intracerebral haemorrhage: experience from the TICH-2 MRI substudy
Related Public URLs https://eso-conference.org/2018/
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf

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ESOC2018 MRI substudy challenges_final1 (002).pdf (407 Kb)
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Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf





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