Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Office 624, 27705 Durham, NC, USA; Duke University School of Nursing, Durham, NC, USA.
Department of Neurology, National Neuroscience Institute, Singapore General Hospital, Singapore.
J Stroke Cerebrovasc Dis. 2021 Mar;30(3):105551. doi: 10.1016/j.jstrokecerebrovasdis.2020.105551. Epub 2020 Dec 19.
The efficacy of thrombolytic therapy with tissue plasminogen activator (tPA) is highly time dependent. Although clinical guidelines do not recommend written informed consent as it may cause treatment delays, local policy can supersede and require it. From 2014 to 2017, three out of five public hospitals in Singapore changed from written to verbal consent at different time points. We aimed to examine the association of hospital policy changes regarding informed consent on door-to-needle (DTN) times.
Using data from the Singapore Stroke Registry and surveys of local practice, we analyzed data of 915 acute ischemic stroke patients treated with tPA within 3 hours in all public hospitals between July 2014 to Dec 2017. Patient-level DTN times before and after policy changes were examined while adjusting for clinical characteristics, within-hospital clustering, and trends over time.
Patient characteristics and stroke severity were similar before and after the policy changes. Overall, the median DTN times decreased from 68 to 53 minutes after the policy changes. After risk adjustment, changing from written to verbal informed consent was associated with a 5.6 minutes reduction (95% CI 1.1-10.0) in DTN times. After the policy changed, the percentage of patients with DTN ≤60 minutes and ≤45 minutes increased from 35.6% to 66.1% (adjusted OR 1.75; 95% CI 1.12-2.74) and 9.3% to 36.0% (adjusted OR 2.42; 95% CI 1.37-4.25), respectively.
Changing from written to verbal consent is associated with significant improvement in the timeliness of tPA administration in acute ischemic stroke.
组织型纤溶酶原激活剂（tPA）溶栓治疗的疗效高度依赖时间。尽管临床指南不建议进行书面知情同意，因为这可能导致治疗延误，但地方政策可以取代并要求进行书面知情同意。2014 年至 2017 年，新加坡的五家公立医院中有三家在不同时间点从书面同意改为口头同意。我们旨在研究关于知情同意的医院政策变化与门到针（DTN）时间的关联。
使用来自新加坡中风登记处和当地实践调查的数据，我们分析了 2014 年 7 月至 2017 年 12 月期间所有公立医院中接受 tPA 治疗的 915 名急性缺血性中风患者的患者水平 DTN 时间。在调整临床特征、医院内聚类和时间趋势后，检查政策变化前后患者的 DTN 时间。
政策变化前后患者特征和中风严重程度相似。总体而言，DTN 时间中位数从政策变化前的 68 分钟减少到 53 分钟。在风险调整后，从书面同意改为口头同意与 DTN 时间减少 5.6 分钟相关（95%CI 1.1-10.0）。政策变化后，DTN≤60 分钟和≤45 分钟的患者比例从 35.6%增加到 66.1%（调整后的 OR 1.75；95%CI 1.12-2.74）和 9.3%增加到 36.0%（调整后的 OR 2.42；95%CI 1.37-4.25）。
从书面同意改为口头同意与急性缺血性中风中 tPA 给药及时性的显著改善相关。
