血管内与神经外科手术治疗动脉瘤的比较：为个体化决策制定和验证临床预测工具而开展的研究方案。
Endovascular versus neurosurgical aneurysm treatment: study protocol for the development and validation of a clinical prediction tool for individualised decision making.
机构信息
Department of Neurology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands
Department of Public Health, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.
出版信息
BMJ Open. 2022 Dec 26;12(12):e065903. doi: 10.1136/bmjopen-2022-065903.
INTRODUCTION
Treatment decisions for aneurysmal subarachnoid haemorrhage patients should be supported by individualised predictions of the effects of aneurysm treatment. We present a study protocol and analysis plan for the development and external validation of models to predict benefit of neurosurgical versus endovascular aneurysm treatment on functional outcome and durability of treatment.
METHODS AND ANALYSIS
We will use data from the International Subarachnoid Aneurysm Trial for model development. The outcomes are functional outcome, measured with modified Rankin Scale at 12 months, and any retreatment or rebleed of the target aneurysm during follow-up. We will develop an ordinal logistic regression model and Cox regression model, considering age, World Federation of Neurological Surgeons grade, Fisher grade, vasospasm at presentation, aneurysm lumen size, aneurysm neck size, aneurysm location and time-to-aneurysm-treatment as predictors. We will test for interactions with treatment and with baseline risk and derive individualised predicted probabilities of treatment benefit. A benefit of ≥5% will be considered clinically relevant. Discriminative performance of the outcome predictions will be assessed with the c-statistic. Calibration will be assessed with calibration plots. Discriminative performance of the benefit predictions will be assessed with the c-for benefit. We will assess internal validity with bootstrapping and external validity with leave-one-out internal-external cross-validation.
ETHICS AND DISSEMINATION
The medical ethical research committee of the Erasmus MC University Medical Center Rotterdam approved the study protocol under the exemption category and waived the need for written informed consent (MEC-2020-0810). We will disseminate our results through an open-access peer-reviewed scientific publication and with a web-based clinical prediction tool.
简介
对颅内动脉瘤性蛛网膜下腔出血患者的治疗决策应基于对动脉瘤治疗效果的个体化预测。我们提出了一个研究方案和分析计划，旨在开发和外部验证预测神经外科手术与血管内治疗对功能结局和治疗效果持久性影响的模型。
方法和分析
我们将使用国际蛛网膜下腔动脉瘤试验的数据进行模型开发。结局是功能结局，用 12 个月时的改良 Rankin 量表测量，以及在随访期间目标动脉瘤的任何再治疗或再出血。我们将开发一个有序逻辑回归模型和 Cox 回归模型，考虑年龄、世界神经外科学会分级、Fisher 分级、发病时血管痉挛、动脉瘤管腔大小、动脉瘤颈部大小、动脉瘤位置和动脉瘤治疗时间作为预测因素。我们将检验与治疗的交互作用和与基线风险的交互作用，并得出个体化的治疗获益预测概率。获益≥5%将被认为具有临床意义。通过 c 统计量评估预测结局的判别性能。通过校准图评估校准。通过 c-for-benefit 评估获益预测的判别性能。我们将通过bootstrap评估内部有效性，通过留一法内部-外部交叉验证评估外部有效性。
伦理和传播
鹿特丹伊拉斯谟医学中心大学医学中心的医学伦理研究委员会根据豁免类别批准了研究方案，并免除了书面知情同意的要求（MEC-2020-0810）。我们将通过开放获取的同行评议科学出版物和基于网络的临床预测工具来传播我们的研究结果。
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