1. Changes in Informed Consent Policy and Treatment Delays in Stroke Thrombolysis.
- Author
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Xu H, De Silva DA, Woon FP, Ong MEH, Matchar DB, Bettger JP, Laskowitz DT, and Xian Y
- Subjects
- Aged, Female, Fibrinolytic Agents adverse effects, Hospitals, Public, Humans, Male, Middle Aged, Policy Making, Registries, Retrospective Studies, Singapore, Stroke diagnosis, Time Factors, Tissue Plasminogen Activator adverse effects, Treatment Outcome, Verbal Behavior, Fibrinolytic Agents therapeutic use, Informed Consent, Stroke drug therapy, Thrombolytic Therapy adverse effects, Time-to-Treatment, Tissue Plasminogen Activator therapeutic use
- Abstract
Objectives: 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., Materials and Methods: 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., Results: 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., Conclusion: Changing from written to verbal consent is associated with significant improvement in the timeliness of tPA administration in acute ischemic stroke., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2021
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