Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.
NIHR Leicester Biomedical Research Centre, Leicester, United Kingdom.
Health Res Policy Syst. 2019 Feb 13;17(1):19. doi: 10.1186/s12961-019-0417-2.
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.
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.
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.
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.
Unique identifier: NCT01422616 .
英国国家健康研究协会临床研究网络于 2010 年首次成立了超急性中风研究中心（HSRCs），以支持多中心超急性（<9 小时）和复杂中风研究。我们通过对一项大型多中心临床试验的特定国家数据的事后分析，评估了这一投资对研究表现和患者结局的影响。
比较 2012 年 6 月至 2015 年 10 月在国家健康研究协会临床研究网络的 HSRCs 和非 HSRCs 招募的国际强化控制高血压和溶栓中风研究（ENCHANTED）中阿替普酶剂量臂的参与者的基线、结局和试验指标数据。
在 774 名 ENCHANTED 英国参与者中（41%为女性；平均年龄 72 岁），502 名（64.9%）来自 9 个 HSRCs，272 名（35.1%）来自 24 个非 HSRCs。HSRCs 的每月招募率较高（中位数 1.5，四分位间距 1.4-2.2 与 0.7，0.5-1.3；p=0.01），随机化至治疗的时间较短（2.6 与 3.1 分钟；p=0.01）与非 HSRCs 相比。HSRC 参与者更年轻，中风严重程度较轻，但调整最小化标准和随机化时重要的基线变量后，90 天死亡或残疾的组间临床重要结局差异仍然存在，无论是通过序贯改良 Rankin 量表评分变化来定义（调整后的 OR 0.82，95%CI 0.62-1.08；p=0.15），评分 2-6（调整后的 OR 0.71，95%CI 0.50-1.01；p=0.05），还是评分 3-6（调整后的 OR 0.82，95%CI 0.57-1.17；p=0.27）。症状性颅内出血无显著差异，且 HSRCs 和非 HSRCs 的低剂量和标准剂量阿替普酶的治疗效果比较也无异质性。
HSRCs 的基础设施投资与研究表现指标的改善相关，特别是在招募和治疗时间方面，与患者结局的临床重要但无统计学显著改善相关。
唯一标识符：NCT01422616。
