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.

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.

Citation

Pszczolkowski, S., Bath, P. M., Sprigg, N., & Dineen, R. A. (2018, May). Recruitment challenges in MRI studies of acute intracerebral haemorrhage: experience from the TICH-2 MRI substudy. Presented at 4th European Stroke Organisation Conference ​(ESOC 2018)

• Conference Name: 4th European Stroke Organisation Conference ​(ESOC 2018)
• Start Date: May 16, 2018
• End Date: May 18, 2018
• Acceptance Date: Feb 22, 2018
• Publication Date: May 16, 2018
• Deposit Date: Apr 23, 2018
• Publicly Available Date: May 16, 2018
• Peer Reviewed: Peer Reviewed
• Public URL: https://nottingham-repository.worktribe.com/output/912949
• Related Public URLs: https://eso-conference.org/2018/
• Contract Date: Apr 23, 2018