Kircheis Gerald, Fleig Wolfgang E, Görtelmeyer Roman, Grafe Susanne, Häussinger Dieter
Department of Gastroenterology, Hepatology and Infectiology, Heinrich-Heine-University Düsseldorf, Moorenstrasse 5, 40225 Düsseldorf, Germany.
J Hepatol. 2007 Nov;47(5):642-50. doi: 10.1016/j.jhep.2007.05.019. Epub 2007 Jul 23.
BACKGROUND/AIMS: The value of paper-pencil tests and West-Haven-criteria for assessment of low-grade hepatic encephalopathy under conditions of a randomized, double-blind, placebo-controlled, clinical trial was evaluated in a cohort of 217 cirrhotics.
Patients were graded at least twice clinically for severity of hepatic encephalopathy and tested concomitantly with a recommended psychometric test battery.
Re-evaluation of the study documentation showed that at study entry 33% and during the study even 50% of the patients were wrongly allocated to minimal or overt hepatic encephalopathy. Despite the participating physicians' training, 31% of the number-connection-tests-A, 20% of the number-connection-tests-B and 28% of the line-tracing-test were in retrospect considered invalid by an independent psychologist. Neither the Portosystemic-Encephalopathy-Syndrome (PSE) test nor the Psychometric-Hepatic-Encephalopathy-Sum (PHES)-score reliably picked up clinical improvement in the individual patient. Although these test scores could statistically differentiate between patients with minimal and overt hepatic encephalopathy, the clinical classification of individual patients into one of the groups will have a high rate of error. The PHES-Score was less balanced than the score derived from the PSE-Syndrome-Test.
Inaccuracies in conducting paper-pencil tests together with the subjectivity and incorrectness of clinical HE-grading question the usefulness of West-Haven-criteria and paper-pencil tests including related scores for quantification of low-grade HE at least in multicenter approaches.
背景/目的:在一项纳入217例肝硬化患者的队列研究中,于随机、双盲、安慰剂对照的临床试验条件下,评估纸笔测试及韦斯特黑文标准对轻度肝性脑病的评估价值。
对患者的肝性脑病严重程度至少进行两次临床分级,并同时使用推荐的心理测量测试组合进行检测。
对研究文档的重新评估显示,在研究入组时33%的患者以及在研究期间甚至50%的患者被错误地归类为轻度或显性肝性脑病。尽管参与研究的医生接受了培训,但独立心理学家回顾性认为,数字连接测试A的31%、数字连接测试B的20%以及划消试验的28%结果无效。门体性脑病综合征(PSE)测试和心理测量肝性脑病总和(PHES)评分均无法可靠地反映个体患者的临床改善情况。虽然这些测试分数在统计学上能够区分轻度和显性肝性脑病患者,但将个体患者临床分类到其中一组时会有较高的错误率。PHES评分不如PSE综合征测试得出的评分均衡。
纸笔测试操作的不准确性以及临床肝性脑病分级的主观性和错误性,质疑了韦斯特黑文标准和纸笔测试(包括相关评分)在至少多中心研究中对轻度肝性脑病进行量化的实用性。