Department of Neurology, University of Erlangen-Nuremberg, Erlangen, Germany.
Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.
Ann Neurol. 2021 Mar;89(3):474-484. doi: 10.1002/ana.25969. Epub 2020 Dec 21.
OBJECTIVE: Outcome prognostication unbiased by early care limitations (ECL) is essential for guiding treatment in patients presenting with intracerebral hemorrhage (ICH). The aim of this study was to determine whether the max-ICH (maximally treated ICH) Score provides improved and clinically useful prognostic estimation of functional long-term outcomes after ICH. METHODS: This multicenter validation study compared the prognostication of the max-ICH Score versus the ICH Score regarding diagnostic accuracy (discrimination and calibration) and clinical utility using decision curve analysis. We performed a joint investigation of individual participant data of consecutive spontaneous ICH patients (n = 4,677) from 2 retrospective German-wide studies (RETRACE I + II; anticoagulation-associated ICH only) conducted at 22 participating centers, one German prospective single-center study (UKER-ICH; nonanticoagulation-associated ICH only), and 1 US-based prospective longitudinal single-center study (MGH; both anticoagulation- and nonanticoagulation-associated ICH), treated between January 2006 and December 2015. RESULTS: Of 4,677 included ICH patients, 1,017 (21.7%) were affected by ECL (German cohort: 15.6% [440 of 2,377]; MGH: 31.0% [577 of 1,283]). Validation of long-term functional outcome prognostication by the max-ICH Score provided good and superior discrimination in patients without ECL compared with the ICH Score (area under the receiver operating curve [AUROC], German cohort: 0.81 [0.78-0.83] vs 0.74 [0.72-0.77], p < 0.01; MGH: 0.85 [0.81-0.89] vs 0.78 [0.74-0.82], p < 0.01), and for the entire cohort (AUROC, German cohort: 0.84 [0.82-0.86] vs 0.80 [0.77-0.82], p < 0.01; MGH: 0.83 [0.81-0.85] vs 0.77 [0.75-0.79], p < 0.01). Both scores showed no evidence of poor calibration. The clinical utility investigated by decision curve analysis showed, at high threshold probabilities (0.8, aiming to avoid false-positive poor outcome attribution), that the max-ICH Score provided a clinical net benefit compared with the ICH Score (14.1 vs 2.1 net predicted poor outcomes per 100 patients). INTERPRETATION: The max-ICH Score provides valid and improved prognostication of functional outcome after ICH. The associated clinical net benefit in minimizing false poor outcome attribution might potentially prevent unwarranted care limitations in patients with ICH. ANN NEUROL 2021;89:474-484.
目的：对于因早期治疗限制（ECL）导致预后偏差的患者，进行不受 ECL 影响的预后评估对于指导治疗非常重要。本研究旨在确定最大脑出血量（max-ICH）评分是否能够提高脑出血患者功能预后的预测准确性（区分度和校准度），并通过决策曲线分析评估其临床实用性。
方法：本多中心验证研究比较了 max-ICH 评分与 ICH 评分在诊断准确性（区分度和校准度）和临床实用性方面的预后预测能力，使用决策曲线分析进行评估。我们联合分析了来自 2 项德国全国范围回顾性研究（RETRACE I + II；仅抗凝相关脑出血）、1 项德国前瞻性单中心研究（UKER-ICH；非抗凝相关脑出血）和 1 项美国前瞻性纵向单中心研究（MGH；抗凝和非抗凝相关脑出血）的连续自发性脑出血患者（n=4677）的个体参与者数据，这些研究均于 2006 年 1 月至 2015 年 12 月间进行。
结果：在纳入的 4677 例脑出血患者中，有 1017 例（21.7%）存在 ECL（德国队列：15.6%[2377 例中的 440 例]；MGH：31.0%[1283 例中的 577 例]）。与 ICH 评分相比，max-ICH 评分在未发生 ECL 的患者中对长期功能预后的预测具有良好且更高的区分度（德国队列：接受者操作特征曲线下面积[AUROC]，0.81[0.78-0.83]比 0.74[0.72-0.77]，p<0.01；MGH：0.85[0.81-0.89]比 0.78[0.74-0.82]，p<0.01），且对整个队列也具有良好的区分度（德国队列：AUROC，0.84[0.82-0.86]比 0.80[0.77-0.82]，p<0.01；MGH：0.83[0.81-0.85]比 0.77[0.75-0.79]，p<0.01）。这两个评分都没有证据表明校准不良。通过决策曲线分析评估的临床实用性表明，在高阈值概率（0.8，旨在避免假阳性预后不良的归因）下，max-ICH 评分与 ICH 评分相比具有临床净获益（每 100 例患者中，max-ICH 评分可多预测 14.1 例不良结局，而 ICH 评分多预测 2.1 例不良结局）。
结论：max-ICH 评分能够对脑出血患者的功能预后进行有效且更准确的预测。该评分可减少错误归因预后不良的情况，从而潜在地防止对脑出血患者不必要的治疗限制。
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