Gluud Lise L, Jeyaraj Rebecca, Morgan Marsha Y
Gastrounit, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, 2650 Hvidovre Denmark.
UCL Institute for Liver & Digestive Health, Division of Medicine, Royal Free Campus, University College London, Rowland Hill Street, Hampstead, London, NW3 2PF, UK.
J Clin Exp Hepatol. 2019 May-Jun;9(3):354-361. doi: 10.1016/j.jceh.2019.02.004. Epub 2019 Feb 15.
Randomised clinical trials and systematic reviews of research findings can provide high-quality evidence for decision-making in the management of patients with hepatic encephalopathy. A large number of clinical trials have been undertaken, over the last 50 years, relative to the prevention and treatment of this condition. However, changes have been made, during this time, in the classification of hepatic encephalopathy, diagnostic criteria and assessment measures. These temporally based changes and the consequent lack of standardisation make it difficult to compare interventions and to evaluate their comparative efficacy and safety. While some consensus has been reached in relation to the diagnostic evaluation, classification and monitoring of patients in clinical trials, there is less surety about the choice of clinical endpoints. These outcome measures should be universally applicable, easily measured and clinically relevant. This article reviews the current recommendations regarding outcome selection and outlines some of the potential problems and pitfalls inherent in clinical trial evaluating interventions for the management of hepatic encephalopathy.
随机临床试验和对研究结果的系统评价可为肝性脑病患者管理决策提供高质量证据。在过去50年里，针对这种疾病的预防和治疗开展了大量临床试验。然而，在此期间，肝性脑病的分类、诊断标准和评估措施发生了变化。这些基于时间的变化以及随之而来的缺乏标准化，使得难以比较干预措施并评估其相对疗效和安全性。虽然在临床试验中患者的诊断评估、分类和监测方面已达成一些共识，但对于临床终点的选择确定性较低。这些结局指标应具有普遍适用性、易于测量且与临床相关。本文回顾了当前关于结局选择的建议，并概述了在评估肝性脑病管理干预措施的临床试验中一些潜在的问题和陷阱。
