Detailed Information on Publication Record
2018
Professional guideline versus product label selection for treatment with IV thrombolysis: An analysis from SITS registry
CAMERON, Alan C., James BOGIE, Azmil H. ABDUL-RAHIM, Niaz AHMED, Michael MAZYA et. al.Basic information
Original name
Professional guideline versus product label selection for treatment with IV thrombolysis: An analysis from SITS registry
Authors
CAMERON, Alan C. (826 United Kingdom of Great Britain and Northern Ireland, guarantor), James BOGIE (826 United Kingdom of Great Britain and Northern Ireland), Azmil H. ABDUL-RAHIM (826 United Kingdom of Great Britain and Northern Ireland), Niaz AHMED (752 Sweden), Michael MAZYA (752 Sweden), Robert MIKULÍK (203 Czech Republic, belonging to the institution), Werner HACKE (276 Germany) and Kennedy R. LEES (826 United Kingdom of Great Britain and Northern Ireland)
Edition
EUROPEAN STROKE JOURNAL, LONDON, SAGE PUBLICATIONS LTD, 2018, 2396-9873
Other information
Language
English
Type of outcome
Článek v odborném periodiku
Field of Study
30210 Clinical neurology
Country of publisher
United Kingdom of Great Britain and Northern Ireland
Confidentiality degree
není předmětem státního či obchodního tajemství
References:
RIV identification code
RIV/00216224:14110/18:00106858
Organization unit
Faculty of Medicine
UT WoS
000429801100005
Keywords in English
Alteplase; product label; professional guideline; thrombolysis
Tags
International impact, Reviewed
Změněno: 8/2/2021 12:51, Mgr. Tereza Miškechová
Abstract
V originále
Introduction Thrombolysis usage in ischaemic stroke varies across sites. Divergent advice from professional guidelines and product labels may contribute. Patients and methods We analysed SITS-International registry patients enrolled January 2010 through June 2016. We grouped sites into organisational tertiles by number of patients arriving 2.5h and treated 3h, percentage arriving 2.5h and treated 3h, and numbers treated 3h. We assigned scores of 1-3 (lower/middle/upper) per variable and 2 for onsite thrombectomy. We classified sites as lower efficiency (summed scores 3-5), medium efficiency (6-8) or higher efficiency (9-11). Sites were also grouped by adherence with European product label and ESO guideline: label adherent' (>95% on-label), guideline adherent' (5% off-label, 95% on-guideline) or guideline non-adherent' (>5% off-guideline). We cross-tabulated site-efficiency and adherence. We estimated the potential benefit of universally selecting by ESO guidance, using onset-to-treatment time-specific numbers needed to treat for day 90 mRS 0-1. Results A total of 56,689 patients at 597 sites were included: 163 sites were higher efficiency, 204 medium efficiency and 230 lower efficiency. Fifty-six sites were label adherent', 204 guideline adherent' and 337 guideline non-adherent'. There were strong associations between site-efficiency and adherence (P<0.001). Almost all label adherent' sites (55, 98%) were lower efficiency. If all patients were treated by ESO guidelines, an additional 17,031 would receive alteplase, which translates into 1922 more patients with favourable three-month outcomes. Discussion Adherence with product labels is highest in lower efficiency sites. Closer alignment with professional guidelines would increase patients treated and favourable outcomes. Conclusion Product labels should be revised to allow treatment of patients 4.5h from onset and aged 80 years.
Links
| LM2015090, research and development project |
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