title: Changes in European Label and Guideline Adherence After Updated Recommendations for Stroke Thrombolysis: Results From the Safe Implementation of Treatments in Stroke Registry.
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-to-treatment time 3 to 4.5 hours, which the label still prohibited. Our aim was to compare contraindication nonadherence before and after the guideline update.
  
  
  RESULTS
  Data on IVT-treated patients with stroke at 232 European hospitals participating in the Safe Implementation of Treatments in Stroke registry during both periods 2006 to 2007 (n=6354) and 2010 to 2011 (n=12 046). After the 2008/2009 guideline update, the proportion of patients nonadherent to label increased from 23.6% to 51.1% (P<0.001). 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.
authors.affiliation: From the Health Informatics Centre, Department of Learning, Informatics, Management and Ethics (N. Anani, R.C., S.K.) and Stroke Research Unit, Department of Clinical Neuroscience (M.V.M., O.B., N. Ahmed, N.W., T.P.M.), Karolinska Institutet, Stockholm, Sweden; Karolinska Stroke Research Unit, Department of Neurology, Karolinska University Hospital Solna, Stockholm, Sweden (M.V.M., N. Ahmed, N.W., T.P.M.); Department of Neurology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (O.B.); and Cambio Healthcare Systems, Stockholm, Sweden (R.C.).
authors.forename: Nadim
authors.initials: N
authors.lastname: Anani
authors.affiliation: From the Health Informatics Centre, Department of Learning, Informatics, Management and Ethics (N. Anani, R.C., S.K.) and Stroke Research Unit, Department of Clinical Neuroscience (M.V.M., O.B., N. Ahmed, N.W., T.P.M.), Karolinska Institutet, Stockholm, Sweden; Karolinska Stroke Research Unit, Department of Neurology, Karolinska University Hospital Solna, Stockholm, Sweden (M.V.M., N. Ahmed, N.W., T.P.M.); Department of Neurology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (O.B.); and Cambio Healthcare Systems, Stockholm, Sweden (R.C.).
authors.forename: Michael V
authors.initials: MV
authors.lastname: Mazya
authors.affiliation: From the Health Informatics Centre, Department of Learning, Informatics, Management and Ethics (N. Anani, R.C., S.K.) and Stroke Research Unit, Department of Clinical Neuroscience (M.V.M., O.B., N. Ahmed, N.W., T.P.M.), Karolinska Institutet, Stockholm, Sweden; Karolinska Stroke Research Unit, Department of Neurology, Karolinska University Hospital Solna, Stockholm, Sweden (M.V.M., N. Ahmed, N.W., T.P.M.); Department of Neurology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (O.B.); and Cambio Healthcare Systems, Stockholm, Sweden (R.C.).
authors.forename: Olivier
authors.initials: O
authors.lastname: Bill
authors.affiliation: From the Health Informatics Centre, Department of Learning, Informatics, Management and Ethics (N. Anani, R.C., S.K.) and Stroke Research Unit, Department of Clinical Neuroscience (M.V.M., O.B., N. Ahmed, N.W., T.P.M.), Karolinska Institutet, Stockholm, Sweden; Karolinska Stroke Research Unit, Department of Neurology, Karolinska University Hospital Solna, Stockholm, Sweden (M.V.M., N. Ahmed, N.W., T.P.M.); Department of Neurology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (O.B.); and Cambio Healthcare Systems, Stockholm, Sweden (R.C.).
authors.forename: Rong
authors.initials: R
authors.lastname: Chen
authors.affiliation: From the Health Informatics Centre, Department of Learning, Informatics, Management and Ethics (N. Anani, R.C., S.K.) and Stroke Research Unit, Department of Clinical Neuroscience (M.V.M., O.B., N. Ahmed, N.W., T.P.M.), Karolinska Institutet, Stockholm, Sweden; Karolinska Stroke Research Unit, Department of Neurology, Karolinska University Hospital Solna, Stockholm, Sweden (M.V.M., N. Ahmed, N.W., T.P.M.); Department of Neurology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (O.B.); and Cambio Healthcare Systems, Stockholm, Sweden (R.C.).
authors.forename: Sabine
authors.initials: S
authors.lastname: Koch
authors.affiliation: From the Health Informatics Centre, Department of Learning, Informatics, Management and Ethics (N. Anani, R.C., S.K.) and Stroke Research Unit, Department of Clinical Neuroscience (M.V.M., O.B., N. Ahmed, N.W., T.P.M.), Karolinska Institutet, Stockholm, Sweden; Karolinska Stroke Research Unit, Department of Neurology, Karolinska University Hospital Solna, Stockholm, Sweden (M.V.M., N. Ahmed, N.W., T.P.M.); Department of Neurology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (O.B.); and Cambio Healthcare Systems, Stockholm, Sweden (R.C.).
authors.forename: Niaz
authors.initials: N
authors.lastname: Ahmed
authors.affiliation: From the Health Informatics Centre, Department of Learning, Informatics, Management and Ethics (N. Anani, R.C., S.K.) and Stroke Research Unit, Department of Clinical Neuroscience (M.V.M., O.B., N. Ahmed, N.W., T.P.M.), Karolinska Institutet, Stockholm, Sweden; Karolinska Stroke Research Unit, Department of Neurology, Karolinska University Hospital Solna, Stockholm, Sweden (M.V.M., N. Ahmed, N.W., T.P.M.); Department of Neurology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (O.B.); and Cambio Healthcare Systems, Stockholm, Sweden (R.C.).
authors.forename: Nils
authors.initials: N
authors.lastname: Wahlgren
authors.affiliation: From the Health Informatics Centre, Department of Learning, Informatics, Management and Ethics (N. Anani, R.C., S.K.) and Stroke Research Unit, Department of Clinical Neuroscience (M.V.M., O.B., N. Ahmed, N.W., T.P.M.), Karolinska Institutet, Stockholm, Sweden; Karolinska Stroke Research Unit, Department of Neurology, Karolinska University Hospital Solna, Stockholm, Sweden (M.V.M., N. Ahmed, N.W., T.P.M.); Department of Neurology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (O.B.); and Cambio Healthcare Systems, Stockholm, Sweden (R.C.). tiago.more@gmail.com.
authors.forename: Tiago
authors.initials: T
authors.lastname: Prazeres Moreira
mesh_terms: D000208:Acute Disease; D061605:Administration, Intravenous; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D000075202:Contraindications; D005060:Europe; D019983:Guideline Adherence; D061847:Hospitals, High-Volume; D006801:Humans; D017410:Practice Guidelines as Topic; D012042:Registries; D020521:Stroke / Q000188:drug therapy*; D015912:Thrombolytic Therapy; D061665:Time-to-Treatment; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*
chemical_list: D010959:Tissue Plasminogen Activator
keywords: contraindications; guideline adherence; practice guidelines; stroke; tissue plasminogen activator