Please use this identifier to cite or link to this item: http://hdl.handle.net/2381/45541
Title: 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.
Authors: Robinson, TG
Wang, X
Durham, AC
Ford, GA
Liao, J
Littlewood, S
Roffe, C
White, P
Chalmers, J
Anderson, CS
ENCHANTED Investigators
First Published: 13-Feb-2019
Publisher: BMC (part of Springer Nature), World Health Organization (WHO)
Citation: Health Research Policy and Systems, 2019, 17, Article number: 19
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. TRIAL REGISTRATION: Unique identifier: NCT01422616 .
DOI Link: 10.1186/s12961-019-0417-2
eISSN: 1478-4505
Links: https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-019-0417-2
http://hdl.handle.net/2381/45541
Version: Publisher Version
Status: Peer-reviewed
Type: Journal Article
Rights: Copyright © the authors, 2019. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Description: The datasets analysed during the current study are available from the corresponding author on reasonable request. Additional files at version of record: Additional file 1: Imaging transfer and analysis, and definitions of symptomatic intracerebral haemorrhage. (DOCX 40 kb) Additional file 2: Table S1. Use of alteplase and management details from randomisation to day 7 by hyperacute stroke research centres (HSRCs) and non-HSRCs. Table S2. Key secondary outcome of symptomatic intracerebral haemorrhage across all definitions by HSRCs and nonHSRCs. Table S3. Key efficacy outcomes by randomised treatment and HSRCs and non-HSRCs. Table S4. Key efficacy outcomes by randomised treatment and HSRCs and non-HSRCs. Table S5. Key safety outcome of symptomatic intracerebral haemorrhage by randomised treatment and HSRCs and non-HSRCs. (DOCX 49 kb)
Appears in Collections:Published Articles, Dept. of Cardiovascular Sciences

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