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Robinson, TG, Wang, X, Durham, AC, Ford, GA, Liao, J, Littlewood, S, Roffe, C ORCID: https://orcid.org/0000-0002-5259-6649, White, P, Chalmers, J, Anderson, CS and Investigators, ENCHANTED (2019) The National Institute for Health Research Hyperacute Stroke Research Centres and the ENCHANTED trial: the impact of enhanced research infrastructure on trial metrics and patient outcomes. Health Research Policy and Systems, 17. pp. 1-8.

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Abstract

Background: The English National Institute for Health Research Clinical Research Network first established Hyperacute Stroke Research Centres (HSRCs) in 2010 to support multicentre hyperacute (< 9 h) and complex stroke research. We assessed the impact of this investment on research performance and patient outcomes in a post-hoc analysis of country-specific data from a large multicentre clinical trial.

Methods: Comparisons of baseline, outcome and trial metric data were made for participants recruited to the alteplase-dose arm of the international Enhanced Control of Hypertension and Thrombolysis Stroke study (ENCHANTED) at National Institute for Health Research Clinical Research Network HSRCs and non-HSRCs between June 2012 and October 2015.

Results: Among 774 ENCHANTED United Kingdom participants (41% female; mean age 72 years), 502 (64.9%) were recruited from nine HSRCs and 272 (35.1%) from 24 non-HSRCs. HSRCs had higher monthly recruitment rates (median 1.5, interquartile interval 1.4-2.2 vs. 0.7, 0.5-1.3; p = 0.01) and shorter randomisation-to-treatment times (2.6 vs. 3.1 min; p = 0.01) compared to non-HSRCs. HSRC participants were younger and had milder stroke severity, but clinically important between-group differences in 90-day death or disability outcomes remained after adjustment for minimisation criteria and important baseline variables at randomisation, whether defined by ordinal modified Rankin scale score shift (adjusted OR 0.82, 95% CI 0.62-1.08; p = 0.15), scores 2 to 6 (adjusted OR 0.71, 95% CI 0.50-1.01; p = 0.05), or scores 3 to 6 (adjusted OR 0.82, 95% CI 0.57-1.17; p = 0.27). There was no significant difference in symptomatic intracerebral haemorrhage, nor heterogeneity in the comparative treatment effects between low- and standard-dose alteplase by HSRCs or non-HSRCs.

Conclusions: Infrastructure investment in HSRCs was associated with improved research performance metrics, particularly recruitment and time to treatment with clinically important, though not statistically significant, improvements in patient outcomes.

Item Type: Article
Additional Information: This is the final published version of the article (version of record). It first appeared online via BioMed Central at http://doi.org/10.1186/s12961-019-0417-2 - please refer to any applicable terms of use of the publisher.
Uncontrolled Keywords: Acute ischaemic stroke, alteplase, clinical trials, symptomatic intracerebral haemorrhage, thrombolysis
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Medicine and Health Sciences > School of Health and Rehabilitation
Depositing User: Symplectic
Date Deposited: 07 Mar 2019 12:31
Last Modified: 29 Mar 2021 09:21
URI: https://eprints.keele.ac.uk/id/eprint/6019

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