Effect of a clinical decision support system on stroke care quality and outcomes in patients with acute ischaemic stroke (GOLDEN BRIDGE II): cluster randomised clinical trial.

Methods

Multicentre, cluster randomised clinical trial.

多中心、群组随机临床试验。

77 hospitals across China.

中国77家医院。

77 hospitals (38 randomised to intervention group, 39 to control group) enrolled 21 603 patients with acute ischaemic stroke admitted to hospital within seven days after symptom onset.

77家医院（其中38家随机分配至干预组，39家至对照组）共招募了21,603名在症状发作后七天内入院的急性缺血性中风患者。

Hospitals in the intervention group received stroke CDSS support including artificial intelligence assisted imaging analysis, classification of stroke causes, and evidence based treatment recommendations.

干预组的医院接受了中风临床决策支持系统（CDSS）的支持，包括人工智能辅助的影像分析、中风原因的分类以及基于证据的治疗建议。

Hospitals in the control group provided usual care.

对照组的医院提供了常规护理。

main_outcomes_measures

The primary outcome was a new vascular event (composite of ischaemic stroke, haemorrhagic stroke, myocardial infarction, and vascular death) within three months after initial symptom onset.

主要结果是在初始症状出现后三个月内发生新的血管事件（包括缺血性中风、出血性中风、心肌梗死和血管性死亡的复合事件）。

Secondary outcomes included the composite measure and all-or-none measure of evidence based performance measures for acute ischaemic stroke care quality, a new vascular event at six and 12 months, and disability (modified Rankin Scale score 3-6) and all cause mortality at three, six, and 12 months.

次要结果包括急性缺血性中风护理质量的基于证据的性能指标的综合测量和全有或全无测量，六个月和12个月时的新血管事件，以及在三个月、六个月和12个月时的残疾（改良Rankin量表评分3-6）和全因死亡率。

Safety outcomes were moderate or severe bleeding events and all bleeding events at three, six, and 12 months.

安全性结果包括中度或重度出血事件以及在三个月、六个月和十二个月时的所有出血事件。

Results

11 054 patients in the intervention group and 10 549 patients in the control group were enrolled from January 2021 to June 2023.

干预组有11,054名患者，对照组有10,549名患者，从2021年1月到2023年6月进行了招募。

New vascular events at three months occurred in 2.9% (320/11 054) in the intervention group compared with 3.9% (416/10 549) in the control group (adjusted hazard ratio0.74, 95% confidence interval(CI) 0.58 to 0.93, P=0.01).

干预组在三个月内新发血管事件的发生率为2.9%（320/11 054），而对照组为3.9%（416/10 549）（调整后的风险比为0.74，95%置信区间（CI）为0.58至0.93，P=0.01）。

The CDSS intervention effect remained significant in the cluster level analysis (-0.01, -0.02 to -0.004, P=0.003).

在群集水平分析中，CDSS干预效果仍然显著（-0.01，-0.02至-0.004，P=0.003）。

Patients in the intervention group were more likely to have a higher composite measure (91.4% (77 049/84 276) v 89.8% (70 794/78 834), adjusted odds ratio 1.21, 95% CI 1.17 to 1.26, P<0.001).

干预组患者更有可能获得更高的综合测量值（91.4% (77 049/84 276) 对比 89.8% (70 794/78 834)，调整后的优势比为1.21，95%置信区间为1.17至1.26，P<0.001）。

New vascular events were significantly lower in the intervention group at 12 months (4.0% (440/11 054) v 5.5% (576/10 549), adjusted hazard ratio0.73, 95% CI 0.56 to 0.95, P=0.02).

在12个月时，干预组的新血管事件显著较低（4.0% (440/11 054) 对比 5.5% (576/10 549)，调整后的风险比为0.73，95%置信区间为0.56至0.95，P=0.02）。

No significant differences were found in disability and all cause mortality.

在残疾和全因死亡率方面，两组之间没有发现显著差异。

Moderate or severe bleeding, and all bleeding did not differ significantly between the two groups.

中度或重度出血以及所有出血在两组之间没有显著差异。

Conclusions

Use of the stroke CDSS in patients with acute ischaemic stroke in China led to a significant decrease in new vascular events at three months.

在中国急性缺血性卒中患者中使用卒中临床决策支持系统导致三个月内新发血管事件显著减少。

The stroke CDSS intervention was also effective in improving stroke care quality and decreasing long term vascular events.

中风CDSS干预措施在提高中风护理质量以及减少长期血管事件方面也显示出有效性。

trial_registration

ClinicalTrials.gov NCT04524624.

ClinicalTrials.gov NCT04524624。

Conclusions

Use of the stroke CDSS in patients with acute ischaemic stroke in China led to a significant decrease in new vascular events at three months.

在中国急性缺血性卒中患者中使用卒中临床决策支持系统导致三个月内新发血管事件显著减少。