Mulder Maxim J H L, Venema Esmee, Roozenbeek Bob, Broderick Joseph P, Yeatts Sharon D, Khatri Pooja, Berkhemer Olvert A, Roos Yvo B W E M, Majoie Charles B L M, van Oostenbrugge Robert J, van Zwam Wim H, van der Lugt Aad, Steyerberg Ewout W, Dippel Diederik W J, Lingsma Hester F
Erasmus University Medical Center, Rotterdam, The Netherlands.
University of Cincinnati, Cincinnati, Ohio, USA.
BMJ Open. 2017 Mar 22;7(3):e013699. doi: 10.1136/bmjopen-2016-013699.
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.
总体而言，动脉内治疗（IAT）已被证明对因前循环近端闭塞导致的急性缺血性卒中患者有益。然而，治疗效果的异质性可能与个性化临床决策相关。我们的目标是通过预测个体治疗的益处或危害来改进IAT患者的选择。
我们将使用在荷兰急性缺血性卒中血管内治疗多中心随机临床试验（MR CLEAN）中收集的数据，来分析基线特征对结局和治疗效果的影响。将开发一个带有交互项的多变量比例优势模型，以预测每位患者接受IAT和未接受IAT时的结局。在对回归系数进行自助重采样和收缩后，模型性能将用区分度和校准度来表示，以校正乐观偏差。将在卒中介入管理III期试验（IMS III）患者的数据上进行外部验证。主要结局将是卒中后90天的改良Rankin量表（mRS）。
拟议的研究将为IAT提供一种国际适用的临床决策辅助工具。研究结果将通过同行评审出版物、会议报告以及在线网络应用工具广泛传播。由于已经收集了原始数据，因此无需正式伦理批准。
ISRCTN10888758；结果公布后注册号及NCT00359424；结果公布后c。
