Changes in European Label and Guideline Adherence After Updated Recommendations for Stroke Thrombolysis

Abstract

Background-Intravenous thrombolysis (IVT) for acute ischemic stroke is subject to label and guideline contraindications.Updated European guidelines in 2008/2009 recommended IVT in selected patients aged >80 years and stroke onset-totreatment time 3 to 4.5 hours, which the label still prohibited. Our aim was to compare contraindication nonadherence before and after the guideline update. Specifically, nonadherence to onset-to-treatment time >3 hours increased from 8.2% to 27.9% and IVT in patients aged >80 years from 8.9% to 17.2% (both P<0.001). Nonadherence also increased to the contraindications severe stroke (National Institutes of Health Stroke Scale score >25), onset-to-treatment time >4.5 hours, blood pressure >185/110 mm Hg, and ongoing oral anticoagulation (all P≤0.001). Higher hospital IVT patient volumes were associated with higher nonadherence rates. Conclusions-After the European guideline update, new recommendations were promptly adopted and nonadherence to the unchanged label increased. Label contraindications should be updated. (Circ Cardiovasc Qual Outcomes. 2015;8: S155-S162. Methods and Results-Data

Impact of Transcranial Doppler Ultrasound on Logistics and Outcomes in Stroke Thrombolysis

“…For categorical variables, we calculated percentage proportions by dividing the number of events by the total number of patients, excluding missing or unknown cases, as in previous SITS publications. 10,12,13 For calculation of significance of difference between proportions, the Pearson χ 2 method was used. To adjust for confounding effects of baseline differences between the groups, multivariate logistic regression analyses were performed to demonstrate whether TCD performed (1) before and (2) during IVT is independently associated with outcomes.…”

Applying openEHR’s Guideline Definition Language to the SITS international stroke treatment registry: a European retrospective observational study

“…We have reported the criteria that led to our patient samples and their clinical importance, which was to provide a basis for studying the way compliance with recommendations changed following a guideline update. The update had been introduced in two documents published in 2008 and 2009, so we studied two samples of patients from hospitals enrolling cases in SITS both in the years 2006 to 2007 ( n  = 6354) as well as 2010 to 2011 ( n  = 12,046) [11]. …”

“…Finally, we compared the compliance rates from our method presented here with the results we obtained in the clinical study above [11], which had used conventional statistical analysis.…”

“…In order to further validate our methodology, the aim of this project was to test it on thousands of real stroke patient case files from the SITS registry and compare the results to those obtained from conventional data analysis using standard statistical software, which we recently reported for a clinical audience [11]. …”

Desfechos clínicos de pacientes com acidente vascular cerebral isquêmico após terapia trombolítica

“…(4) Since the early 2000s, the standard pharmacological treatment for acute ischemic stroke has been thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA). (5) The effectiveness of this therapy has been demonstrated; however, there are still challenges in the implementation of thrombolytic treatment protocols and few ischemic stroke patients benefit from this therapy. One of the main limiting factors is time.…”