Anstee Quentin M, Hallsworth Kate, Lynch Niall, Hauvespre Adrien, Mansour Eid, Kozma Sam, Marino John-Paul, Bottomley Juliana, Piercy James, Higgins Victoria
Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
Newcastle National Institute for Health Research Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
JHEP Rep. 2021 Nov 22;4(1):100411. doi: 10.1016/j.jhepr.2021.100411. eCollection 2022 Jan.
BACKGROUND & AIMS: Despite availability of diagnostic and management reference guidelines outlining standard of care for patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), national and regional guidelines are lacking, resulting in variations in patient management between regions. We retrospectively analyzed patient characteristics and management data from the Adelphi Real World NASH Disease Specific Programme™ for patients with NASH in the EU5, Canada, and the Middle East to identify gaps between real-world practice and that advocated by reference guidelines, irrespective of clinician awareness or consultation of guidelines.
We performed an analysis of physicians (hepatologists, gastroenterologists, diabetologists) and their patients diagnosed with NASH. Physicians completed patient record forms for the next 5 consulting patients, collecting information on patient care, including diagnosis and disease management.
A total of 429 physicians provided data for 2,267 patients with NASH (EU5, n = 1,844; Canada, n = 130; Middle East, n = 293). Patient age, physician-defined fibrosis stage, comorbidities and symptoms, and diagnostic testing practices highlighted statistically significant differences across regions. Substantial disconnects between reference guidelines and real-world practice were observed. Use of liver function tests, non-invasive tests ( ultrasound and transient elastography), and tests to exclude other conditions was suboptimal. Although lifestyle advice was widely provided, patients were less commonly referred to diet, exercise, and lifestyle specialists. Two-thirds of patients were receiving off-label treatment for NASH or associated underlying conditions with the aim of improving NASH, most commonly statins, metformin, and vitamin E.
Real-world NASH management approaches differ across regions and from proposed standard of care represented by reference multidisciplinary guidelines. Establishment and awareness of, and adherence to regional and national guidelines may improve identification and management of patients with NASH and potentially improve outcomes in this population.
Although reference guidelines are available to guide the management of patients with NASH, these are not widely used and there is a lack of national guidelines. Our study shows how clinical practice in the EU, Canada, and Middle East differs from proposed standard of care, particularly relating to how patients are diagnosed and treated. Wider establishment of, awareness of, and reference to guidelines may improve how physicians identify and manage patients with NASH.
尽管有诊断和管理参考指南概述了非酒精性脂肪性肝病（NAFLD）和非酒精性脂肪性肝炎（NASH）患者的护理标准，但国家和地区指南却付诸阙如，导致各地区患者管理存在差异。我们回顾性分析了来自阿德尔菲真实世界NASH疾病专项计划™的欧盟五国、加拿大和中东地区NASH患者的特征和管理数据，以确定现实世界实践与参考指南所倡导的实践之间的差距，而不考虑临床医生对指南的了解或参考情况。
我们对诊断为NASH的医生（肝病学家、胃肠病学家、糖尿病学家）及其患者进行了分析。医生为接下来的5名咨询患者填写患者记录表，收集有关患者护理的信息，包括诊断和疾病管理。
共有429名医生为2267名NASH患者提供了数据（欧盟五国，n = 1844；加拿大，n = 130；中东，n = 293）。患者年龄、医生定义的纤维化阶段、合并症和症状以及诊断测试实践在各地区存在统计学上的显著差异。观察到参考指南与现实世界实践之间存在重大脱节。肝功能测试、非侵入性测试（超声和瞬时弹性成像）以及排除其他疾病的测试的使用并不理想。尽管广泛提供了生活方式建议，但患者很少被转介给饮食、运动和生活方式专家。三分之二的患者正在接受针对NASH或相关基础疾病的标签外治疗，目的是改善NASH，最常用的药物是他汀类药物、二甲双胍和维生素E。
现实世界中NASH的管理方法因地区而异，也与多学科参考指南所代表的建议护理标准不同。制定并提高对地区和国家指南的认识以及遵守这些指南，可能会改善NASH患者的识别和管理，并有可能改善该人群的治疗结果。
尽管有参考指南可用于指导NASH患者的管理，但这些指南并未得到广泛应用，而且缺乏国家指南。我们的研究表明了欧盟、加拿大和中东地区的临床实践与建议的护理标准有何不同，特别是在患者的诊断和治疗方式方面。更广泛地制定、提高对指南的认识并参考指南，可能会改善医生识别和管理NASH患者的方式。
