TY - JOUR
T1 - Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: 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
Y1 - 2017
N2 - 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 decision-making. Our aim is to improve selection of patients for IAT by predicting individual treatment benefit or harm. 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. 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. ISRCTN10888758; Post-results and NCT00359424; Post-resultsc
AB - 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 decision-making. Our aim is to improve selection of patients for IAT by predicting individual treatment benefit or harm. 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. 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. ISRCTN10888758; Post-results and NCT00359424; Post-resultsc
U2 - https://doi.org/10.1136/bmjopen-2016-013699
DO - https://doi.org/10.1136/bmjopen-2016-013699
M3 - Article
C2 - 28336740
SN - 2044-6055
VL - 7
SP - e013699
JO - BMJ Open
JF - BMJ Open
IS - 3
ER -