Objectives:The SRealCLL study described the occurrence of adverse events (AEs) and healthcare resource utilization in patients with chronic lymphocytic leukaemia (CLL) using artificial intelligence in a real-world scenario in Spain.Methods:We collected real-world data on patients with CLL from seven Spanish hospitals between January 2016 and December 2018, focusing on their AE and healthcare service utilization. Data extraction from electronic health records of 385,904 patients was performed using the EHRead®technology, which is based on natural language processing and machine learning.Results:Among the 534 CLL patients finally included, 270 (50.6%) were categorized as watch and wait (W&W), 230 (43.1%) as first-line treatment (1L), and 58 (10.9%) as relapse/refractory with second-line treatment (2L). The median study follow-up periods were 14.4, 8.4, and 6 months for W&W, 1L, and 2L, respectively. The most common antineoplastic treatments were ibrutinib (64.8%) and bendamustine + rituximab (12.6%) in 1L, and ibrutinib (62.1%) and venetoclax (15.5%) in 2L. Among the most frequent AEs, anaemia and thrombocytopenia presented higher rates in the treated groups (1L and 2L) compared with W&W (2.01 and 2.32 vs. 0.93;p≤ 0.05 and 1.29 and 1.62 vs. 0.42;p≤ 0.05). Moreover, several AEs, such as major bleeding, digestive symptoms, general symptoms, or Richter syndrome, were more frequent in 1L than W&W (allp≤ 0.05). No differences were shown between groups in the rates of outpatient visits. However, rates of outpatient visits due to AE were higher in 1L than in W&W (1.07 vs. 0.65,p≤ 0.05). The rates of patients being hospitalized were higher in the treated groups compared to W&W (1.68 and 1.9 vs. 0.88;p≤ 0.05), and those due to AE were higher in 1L than W&W (1.23 vs. 0.60;p≤ 0.05).Conclusions:Patients with CLL in 1L or 2L treatments often require healthcare resources due to AEs, particularly cytopenias. The methodology used in this study likely enabled us to identify higher rates of AEs that may be underreported using other real-world approaches. Addressing AEs with effective agents that maximize patient safety and optimize healthcare resource use is crucial in this typically older and comorbid population.
目的：SRealCLL研究描述了在西班牙真实世界场景中，利用人工智能技术观察慢性淋巴细胞白血病（CLL）患者不良事件（AEs）的发生情况及医疗资源使用情况。 方法：我们收集了2016年1月至2018年12月期间来自西班牙七家医院的CLL患者真实世界数据，重点关注其不良事件和医疗服务利用情况。使用基于自然语言处理和机器学习的EHRead®技术，从385,904名患者的电子健康记录中提取数据。 结果：在最终纳入的534名CLL患者中，270名（50.6%）被归类为观察等待（W&W），230名（43.1%）为一线治疗（1L），58名（10.9%）为接受二线治疗的复发/难治性患者（2L）。W&W、1L和2L组的中位研究随访期分别为14.4、8.4和6个月。最常见的抗肿瘤治疗方案在1L组为伊布替尼（64.8%）和苯达莫司汀+利妥昔单抗（12.6%），在2L组为伊布替尼（62.1%）和维奈托克（15.5%）。在最常见的不良事件中，与W&W组相比，治疗组（1L和2L）的贫血和血小板减少发生率更高（2.01和2.32 vs. 0.93；p≤0.05 以及 1.29和1.62 vs. 0.42；p≤0.05）。此外，一些不良事件，如大出血、消化道症状、全身症状或Richter综合征，在1L组比W&W组更常见（所有p≤0.05）。各组在门诊就诊率方面未显示差异。然而，因不良事件导致的门诊就诊率在1L组高于W&W组（1.07 vs. 0.65，p≤0.05）。与W&W组相比，治疗组的患者住院率更高（1.68和1.9 vs. 0.88；p≤0.05），且因不良事件导致的住院率在1L组高于W&W组（1.23 vs. 0.60；p≤0.05）。 结论：接受1L或2L治疗的CLL患者常因不良事件（尤其是血细胞减少）需要医疗资源。本研究采用的方法可能使我们识别出更高的不良事件发生率，这些事件在使用其他真实世界研究方法时可能存在漏报。在这一通常年龄较大且合并症较多的患者群体中，使用能最大限度保障患者安全并优化医疗资源使用的有效药物来处理不良事件至关重要。
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