NeuroTransData, 86633 Neuburg an der Donau, Germany.
Rewoso, Zürich, Switzerland.
Mult Scler Relat Disord. 2024 Oct;90:105844. doi: 10.1016/j.msard.2024.105844. Epub 2024 Aug 23.
Accurate diagnosis of secondary progression in multiple sclerosis (MS) remains a challenge since standardized criteria are missing. In 2016, the MSBase registry presented an algorithm that enabled the diagnosis of secondary progressive multiple sclerosis (SPMS) more than three years earlier compared to diagnosis by neurologists. This work aimed to test whether this approach is equally effective in a real-world cohort of MS patients.
This longitudinal retrospective study analyzed clinical data of outpatients with MS recorded until October 2020 in the NeuroTransData registry, a Germany-wide network of 153 certified neurologists. Patient data had been captured in time during clinical visits employing a defined standardized clinical data set in the webbased NeuroTransData patient management platform DESTINY®. The time between the diagnosis of relapsing-remitting multiple sclerosis (RRMS) to SPMS onset was compared with one determined using MSBase criteria (MSBC). Group 1 consisted of patients diagnosed with SPMS during the observation period, whereas group 2 included RRMS patients who did not convert to SPMS during the observation period.
Of 21,281 patients with MS included in our registry, 194 and 9506 patients were allocated to groups 1 and 2, respectively. 10.3% of patients with RRMS were diagnosed with SPMS simultaneously, whereas 60.8% were diagnosed with SPMS at least 3 months earlier by treating neurologists compared to the MSBC. In group 1, the MSBC showed a low sensitivity of 32.0% and an accuracy of 61.4% but a high specificity of 89.6%. In group 2, the MSBC identified 7.8% of patients with SPMS at some point during the observation time. Moreover, test-retest variability remains a challenge since 29.4% of patients diagnosed with SPMS by treating physicians did not fulfil the MSBC at a later point in time.
These results are inconsistent with earlier SPMS diagnosis using the MSBC compared to clinical diagnosis by treating physicians. Therefore, there remains a need for an operational, structured, and validated approach to SPMS diagnosis.
由于缺乏标准化标准，准确诊断多发性硬化症（MS）的继发性进展仍然是一个挑战。2016 年，MSBase 登记处提出了一种算法，与神经病学家的诊断相比，该算法能够提前三年以上诊断出继发性进展型多发性硬化症（SPMS）。本研究旨在测试该方法在 MS 患者的真实队列中是否同样有效。
这项纵向回顾性研究分析了截至 2020 年 10 月在德国 153 位认证神经病学家组成的神经 TransData 网络的神经 TransData 登记处中记录的门诊 MS 患者的临床数据。患者数据是在临床就诊期间使用基于网络的神经 TransData 患者管理平台 DESTINY®中定义的标准化临床数据集实时捕获的。将从复发缓解型多发性硬化症（RRMS）诊断到 SPMS 发作的时间与使用 MSBase 标准（MSBC）确定的时间进行比较。第 1 组由在观察期间诊断为 SPMS 的患者组成，而第 2 组由在观察期间未转化为 SPMS 的 RRMS 患者组成。
在我们的登记处中，有 21281 名 MS 患者，其中 194 名和 9506 名患者分别被分配到第 1 组和第 2 组。同时诊断出 10.3%的 RRMS 患者为 SPMS，而与 MSBC 相比，60.8%的 RRMS 患者由治疗神经病学家至少提前 3 个月诊断为 SPMS。在第 1 组中，MSBC 的灵敏度为 32.0%，准确性为 61.4%，但特异性为 89.6%。在第 2 组中，MSBC 在观察期间的某个时间点识别出 7.8%的 SPMS 患者。此外，测试-再测试的变异性仍然是一个挑战，因为 29.4%的由治疗医生诊断为 SPMS 的患者在以后的某个时间点未满足 MSBC 的标准。
这些结果与使用 MSBC 进行 SPMS 诊断相比，与治疗医生的临床诊断不一致。因此，仍然需要一种操作、结构化和验证的 SPMS 诊断方法。
