一项真实世界的欧洲调查:非酒精性脂肪性肝炎患者中医生陈述的与临床来源的参考纤维化评分的一致性

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL Pragmatic and Observational Research Pub Date : 2023-01-01 DOI:10.2147/POR.S392320
Quentin M Anstee, Kate Hallsworth, Niall Lynch, Adrien Hauvespre, Eid Mansour, Sam Kozma, Juliana Bottomley, Gary Milligan, James Piercy, Victoria Higgins
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摘要

目的: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适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,但也使用了侵入性较小的方法,例如纤维化-4指数(FIB-4)和振动控制瞬变弹性成像(VCTE),可用于无/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纤维化的主观评估和参考阈值,以了解现实世界中的分类。方法:数据来自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疾病特定计划。医生(糖尿病学家、胃肠病学家、肝病学家)对5名连续接受常规治疗的NASH患者完成问卷调查。基于现有信息的医生陈述的纤维化评分(PSFS)与临床定义的参考纤维化分期(CRFS)进行比较,CRFS采用VCTE和FIB-4数据以及8个参考阈值进行回顾性测定。结果:1111例患者有VCTE (n = 1115)和/或FIB-4 (n = 524)。根据阈值,医生低估了16-33% (FIB-4)和27-50% (VCTE)患者的严重程度。当VCTE≥12.2时,糖尿病学家、胃肠病学家和肝病学家分别低估了35%、32%和27%的患者的疾病严重程度,高估了3%、4%和9%的患者的纤维化(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学家(分别为52%、56%和47%)。结论:在NASH现实环境中,PSFS与CRFS并不一致。低估比高估更常见,可能导致晚期纤维化患者治疗不足。需要对纤维化分类时检测结果的解释提供更多指导,从而改善NASH的管理。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Alignment of Physician-Stated vs Clinically Derived Reference Fibrosis Score in Patients with Non-Alcoholic Steatohepatitis: A Real-World European Survey.

Objective: 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.

Methods: Data were drawn from Adelphi Real World NASH Disease Specific ProgrammeTM 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.

Results: 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).

Conclusion: 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.

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Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
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期刊介绍: Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
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