TY - JOUR
T1 - Towards personalised intra- arterial treatment of patients with acute ischaemic stroke
T2 - a study protocol for development and validation of a clinical decision aid
AU - Mulder, Maxim J. H. L.
AU - Venema, Esmee
AU - Roozenbeek, Bob
AU - Broderick, Joseph P.
AU - Yeatts, Sharon D.
AU - Khatri, Pooja
AU - Berkhemer, Olvert A.
AU - Roos, Yvo B. W. E. M.
AU - Majoie, Charles B. L. M.
AU - van Oostenbrugge, Robert J.
AU - van Zwam, Wim H.
AU - van der Lugt, Aad
AU - Steyerberg, Ewout W.
AU - Dippel, Diederik W. J.
AU - Lingsma, Hester F.
PY - 2017/3
Y1 - 2017/3
N2 - Introduction: Overall, intra- arterial treatment (IAT) proved to be beneficial in patients with acute ischaemic stroke due to a proximal occlusion in the anterior circulation. However, heterogeneity in treatment benefit may be relevant for personalised clinical decisionmaking. Our aim is to improve selection of patients for IAT by predicting individual treatment benefit or harm.Methods and analysis: We will use data collected in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) trial to analyse the effect of baseline characteristics on outcome and treatment effect. A multivariable proportional odds model with interaction terms will be developed to predict the outcome for each individual patient, both with and without IAT. Model performance will be expressed as discrimination and calibration, after bootstrap resampling and shrinkage of regression coefficients, to correct for optimism. External validation will be conducted on data of patients in the Interventional Management of Stroke III trial (IMS III). Primary outcome will be the modified Rankin Scale (mRS) at 90 days after stroke.Ethics and dissemination: The proposed study will provide an internationally applicable clinical decision aid for IAT. Findings will be disseminated widely through peer- reviewed publications, conference presentations and in an online web application tool. Formal ethical approval was not required as primary data were already collected.
AB - Introduction: Overall, intra- arterial treatment (IAT) proved to be beneficial in patients with acute ischaemic stroke due to a proximal occlusion in the anterior circulation. However, heterogeneity in treatment benefit may be relevant for personalised clinical decisionmaking. Our aim is to improve selection of patients for IAT by predicting individual treatment benefit or harm.Methods and analysis: We will use data collected in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) trial to analyse the effect of baseline characteristics on outcome and treatment effect. A multivariable proportional odds model with interaction terms will be developed to predict the outcome for each individual patient, both with and without IAT. Model performance will be expressed as discrimination and calibration, after bootstrap resampling and shrinkage of regression coefficients, to correct for optimism. External validation will be conducted on data of patients in the Interventional Management of Stroke III trial (IMS III). Primary outcome will be the modified Rankin Scale (mRS) at 90 days after stroke.Ethics and dissemination: The proposed study will provide an internationally applicable clinical decision aid for IAT. Findings will be disseminated widely through peer- reviewed publications, conference presentations and in an online web application tool. Formal ethical approval was not required as primary data were already collected.
KW - MODERN MODELING TECHNIQUES
KW - HEALTH-CARE PROFESSIONALS
KW - TRAUMATIC BRAIN-INJURY
KW - CLOT BURDEN SCORE
KW - INTRAVENOUS T-PA
KW - ENDOVASCULAR THERAPY
KW - INTRAARTERIAL TREATMENT
KW - EARLY MANAGEMENT
KW - CT ANGIOGRAPHY
KW - TRIAL
U2 - 10.1136/bmjopen-2016-013699
DO - 10.1136/bmjopen-2016-013699
M3 - Article
C2 - 28336740
SN - 2044-6055
VL - 7
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - 013699
ER -