Anstee Quentin M, Hallsworth Kate, Lynch Niall, Hauvespre Adrien, Mansour Eid, Kozma Sam, Bottomley Juliana, Milligan Gary, Piercy James, Higgins Victoria
Translational & Clinical Research Institute, Faculty of Medical Sciences, University of Newcastle, Newcastle Upon Tyne, UK.
Liver Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Pragmat Obs Res. 2023 Feb 24;14:13-27. doi: 10.2147/POR.S392320. eCollection 2023.
Stratifying disease severity in patients with non-alcoholic steatohepatitis (NASH) is essential for appropriate treatment and long-term management. Liver biopsy is the reference standard for fibrosis severity in NASH, but less invasive methods are used, eg, Fibrosis-4 Index (FIB-4) and vibration-controlled transient elastography (VCTE), for which reference thresholds for no/early fibrosis and advanced fibrosis are available. We compared subjective physician assessment of NASH fibrosis versus reference thresholds to understand classification in a real-world setting.
Data were drawn from Adelphi Real World NASH Disease Specific Programme conducted in France, Germany, Italy, Spain and UK in 2018. Physicians (diabetologists, gastroenterologists, hepatologists) completed questionnaires for five consecutive NASH patients presenting for routine care. Physician-stated fibrosis score (PSFS) based on available information was compared with clinically defined reference fibrosis stage (CRFS) determined retrospectively using VCTE and FIB-4 data and eight reference thresholds.
One thousand two hundred and eleven patients had VCTE (n = 1115) and/or FIB-4 (n = 524). Depending on thresholds, physicians underestimated severity in 16-33% (FIB-4) and 27-50% of patients (VCTE). Using VCTE ≥12.2, diabetologists, gastroenterologists and hepatologists underestimated disease severity in 35%, 32%, and 27% of patients, respectively, and overestimated fibrosis in 3%, 4%, and 9%, respectively (p = 0.0083 across specialties). Hepatologists and gastroenterologists had higher liver biopsy rates than diabetologists (52%, 56%, 47%, respectively).
PSFS did not consistently align with CRFS in this NASH real-world setting. Underestimation was more common than overestimation, potentially leading to undertreatment of patients with advanced fibrosis. More guidance on interpreting test results when classifying fibrosis is needed, thereby improving management of NASH.
对非酒精性脂肪性肝炎（NASH）患者的疾病严重程度进行分层，对于恰当的治疗和长期管理至关重要。肝活检是NASH纤维化严重程度的参考标准，但也会采用侵入性较小的方法，例如Fibrosis-4指数（FIB-4）和振动控制瞬时弹性成像（VCTE），对于这些方法，已有无/早期纤维化和晚期纤维化的参考阈值。我们比较了医生对NASH纤维化的主观评估与参考阈值，以了解实际临床中的分类情况。
数据取自2018年在法国、德国、意大利、西班牙和英国开展的阿德尔菲真实世界NASH疾病专项项目。医生（糖尿病专家、胃肠病学家、肝病学家）为连续就诊的5例接受常规治疗的NASH患者填写问卷。将基于现有信息得出的医生陈述纤维化评分（PSFS）与使用VCTE和FIB-4数据及八个参考阈值回顾性确定的临床定义参考纤维化阶段（CRFS）进行比较。
1211例患者进行了VCTE检查（n = 1115）和/或FIB-4检查（n = 524）。根据阈值不同，医生低估了16% - 33%（FIB-4）和27% - 50%的患者（VCTE）的严重程度。使用VCTE≥12.2时，糖尿病专家、胃肠病学家和肝病学家分别低估了35%、32%和27%患者的疾病严重程度，分别高估纤维化的患者比例为3%、4%和9%（各专科p = 0.0083）。肝病学家和胃肠病学家的肝活检率高于糖尿病专家（分别为52%、56%、47%）。
在这个NASH实际临床环境中，PSFS与CRFS并不始终一致。低估比高估更常见，这可能导致晚期纤维化患者治疗不足。在对纤维化进行分类时，需要更多关于解读检测结果的指导，从而改善NASH的管理。
