Gwee Kok-Ann, Bergmans Paul, Kim JinYong, Coudsy Bogdana, Sim Angelia, Chen Minhu, Lin Lin, Hou Xiaohua, Wang Huahong, Goh Khean-Lee, Pangilinan John A, Kim Nayoung, Varannes Stanislas Bruley des
Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Biometrics Department, Janssen Cilag Benelux, Tilburg, The Netherlands.
J Neurogastroenterol Motil. 2017 Apr 30;23(2):262-272. doi: 10.5056/jnm16095.
BACKGROUND/AIMS: There is a need for a simple and practical tool adapted for the diagnosis of chronic constipation (CC) in the Asian population. This study compared the Asian Neurogastroenterology and Motility Association (ANMA) CC tool and Rome III criteria for the diagnosis of CC in Asian subjects.
This multicenter, cross-sectional study included subjects presenting at outpatient gastrointestinal clinics across Asia. Subjects with CC alert symptoms completed a combination Diagnosis Questionnaire to obtain a diagnosis based on 4 different diagnostic methods: self-defined, investigator's judgment, ANMA CC tool, and Rome III criteria. The primary endpoint was the level of agreement/disagreement between the ANMA CC diagnostic tool and Rome III criteria for the diagnosis of CC.
The primary analysis comprised of 449 subjects, 414 of whom had a positive diagnosis according to the ANMA CC tool. Rome III positive/ANMA positive and Rome III negative/ANMA negative diagnoses were reported in 76.8% and 7.8% of subjects, respectively, resulting in an overall percentage agreement of 84.6% between the 2 diagnostic methods. The overall percentage disagreement between these 2 diagnostic methods was 15.4%. A higher level of agreement was seen between the ANMA CC tool and self-defined (374 subjects [90.3%]) or investigator's judgment criteria (388 subjects [93.7%]) compared with the Rome III criteria.
This study demonstrates that the ANMA CC tool can be a useful for Asian patients with CC.
背景/目的：需要一种适用于亚洲人群慢性便秘（CC）诊断的简单实用工具。本研究比较了亚洲神经胃肠病学和动力协会（ANMA）的CC工具与罗马Ⅲ标准在亚洲受试者CC诊断中的应用。
这项多中心横断面研究纳入了亚洲各地门诊胃肠诊所的受试者。有CC警示症状的受试者完成一份综合诊断问卷，以通过4种不同诊断方法得出诊断结果：自我定义、研究者判断、ANMA CC工具和罗马Ⅲ标准。主要终点是ANMA CC诊断工具与罗马Ⅲ标准在CC诊断上的一致/不一致程度。
初步分析包括449名受试者，其中414名根据ANMA CC工具诊断为阳性。罗马Ⅲ标准阳性/ANMA标准阳性和罗马Ⅲ标准阴性/ANMA标准阴性诊断的受试者分别占76.8%和7.8%，两种诊断方法的总体一致率为84.6%。这两种诊断方法的总体不一致率为15.4%。与罗马Ⅲ标准相比，ANMA CC工具与自我定义（374名受试者[90.3%]）或研究者判断标准（388名受试者[93.7%]）之间的一致性更高。
本研究表明，ANMA CC工具对亚洲CC患者可能有用。
