Professional guideline versus product label selection for
treatment with IV thrombolysis: An analysis from SITS registry

J 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:

URL

RIV identification code

RIV/00216224:14110/18:00106858

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1177/2396987317747737

UT WoS

000429801100005

Keywords in English

Alteplase; product label; professional guideline; thrombolysis

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

Name: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Acronym: CZECRIN)

Investor: Ministry of Education, Youth and Sports of the CR

Citovat

CAMERON, Alan C., James BOGIE, Azmil H. ABDUL-RAHIM, Niaz AHMED, Michael MAZYA, Robert MIKULÍK, Werner HACKE and Kennedy R. LEES. Professional guideline versus product label selection for treatment with IV thrombolysis: An analysis from SITS registry. EUROPEAN STROKE JOURNAL. LONDON: SAGE PUBLICATIONS LTD, 2018, vol. 3, No 1, p. 39-46. ISSN 2396-9873. Available from: https://dx.doi.org/10.1177/2396987317747737.

@article{1526402,
   author = {Cameron, Alan C. and Bogie, James and AbdulandRahim, Azmil H. and Ahmed, Niaz and Mazya, Michael and Mikulík, Robert and Hacke, Werner and Lees, Kennedy R.},
   article_location = {LONDON},
   article_number = {1},
   doi = {http://dx.doi.org/10.1177/2396987317747737},
   keywords = {Alteplase; product label; professional guideline; thrombolysis},
   language = {eng},
   issn = {2396-9873},
   journal = {EUROPEAN STROKE JOURNAL},
   title = {Professional guideline versus product label selection for treatment with IV thrombolysis: An analysis from SITS registry},
   url = {https://journals.sagepub.com/doi/10.1177/2396987317747737},
   volume = {3},
   year = {2018}
}

TY  - JOUR
ID  - 1526402
AU  - Cameron, Alan C. - Bogie, James - Abdul-Rahim, Azmil H. - Ahmed, Niaz - Mazya, Michael - Mikulík, Robert - Hacke, Werner - Lees, Kennedy R.
PY  - 2018
TI  - Professional guideline versus product label selection for treatment with IV thrombolysis: An analysis from SITS registry
JF  - EUROPEAN STROKE JOURNAL
VL  - 3
IS  - 1
SP  - 39-46
EP  - 39-46
PB  - SAGE PUBLICATIONS LTD
SN  - 23969873
KW  - Alteplase
KW  - product label
KW  - professional guideline
KW  - thrombolysis
UR  - https://journals.sagepub.com/doi/10.1177/2396987317747737
L2  - https://journals.sagepub.com/doi/10.1177/2396987317747737
N2  - 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.
ER  -

CAMERON, Alan C., James BOGIE, Azmil H. ABDUL-RAHIM, Niaz AHMED, Michael MAZYA, Robert MIKULÍK, Werner HACKE and Kennedy R. LEES. Professional guideline versus product label selection for treatment with IV thrombolysis: An analysis from SITS registry. \textit{EUROPEAN STROKE JOURNAL}. LONDON: SAGE PUBLICATIONS LTD, 2018, vol.~3, No~1, p.~39-46. ISSN~2396-9873. Available from: https://dx.doi.org/10.1177/2396987317747737.

Detailed Information on Publication Record