当前位置:
X-MOL 学术
›
Am. J. Gastroenterol.
›
论文详情
Our official English website, www.x-mol.net, welcomes your
feedback! (Note: you will need to create a separate account there.)
The Liver Cirrhosis Network Cohort Study: Cirrhosis Definition, Study Population, and Endpoints.
The American Journal of Gastroenterology ( IF 8.0 ) Pub Date : 2024-07-17 , DOI: 10.14309/ajg.0000000000002953 Elliot B Tapper 1 , David Goldberg 2 , Neehar D Parikh 1 , Norah A Terrault 3 , Nicole Welch 4 , Suzanne Sharpton 5 , Bilal Hameed 6 , Mandana Khalili 6 , Andrew Stolz 3 , Elizabeth C Verna 7 , Robert S Brown 8 , Arun J Sanyal 9 , Lisa VanWagner 10 , Daniela P Ladner 11 , Cynthia A Moylan 12 , Anna Mae Diehl 12 , Patricia D Jones 2 , Rohit Loomba 5 , Srinivasan Dasarathy 4 , Douglas A Simonetto 13 , Vijay H Shah 13 , Jasmohan S Bajaj 9 ,
The American Journal of Gastroenterology ( IF 8.0 ) Pub Date : 2024-07-17 , DOI: 10.14309/ajg.0000000000002953 Elliot B Tapper 1 , David Goldberg 2 , Neehar D Parikh 1 , Norah A Terrault 3 , Nicole Welch 4 , Suzanne Sharpton 5 , Bilal Hameed 6 , Mandana Khalili 6 , Andrew Stolz 3 , Elizabeth C Verna 7 , Robert S Brown 8 , Arun J Sanyal 9 , Lisa VanWagner 10 , Daniela P Ladner 11 , Cynthia A Moylan 12 , Anna Mae Diehl 12 , Patricia D Jones 2 , Rohit Loomba 5 , Srinivasan Dasarathy 4 , Douglas A Simonetto 13 , Vijay H Shah 13 , Jasmohan S Bajaj 9 ,
Affiliation
INTRODUCTION
One of the primary goals of the Liver Cirrhosis Network (LCN) is to develop a cohort study to better understand and predict the risk of hepatic decompensation and other clinical and patient-reported outcomes among patients with Child A cirrhosis.
METHODS
The LCN consists of a Scientific Data Coordinating Center and 10 clinical centers whose investigators populate multiple committees. The LCN Definitions and Measurements Committee developed preliminary definitions of cirrhosis and its complications by literature review, expert opinion, and reviewing definition documents developed by other organizations. The Cohort Committee developed the study protocol with the input of the steering committee.
RESULTS
The LCN developed a prospective cohort study to describe and predict the rates of incident clinical events pertaining to first decompensation and patient-reported outcomes. The LCN developed a pragmatic definition of compensated cirrhosis incorporating clinical, laboratory, imaging, and histological criteria. Definitions of incident and recompensated ascites, overt hepatic encephalopathy, variceal hemorrhage, bleeding because of portal gastropathy, and hepatocellular carcinoma were also codified.
DISCUSSION
The LCN Cohort Study design will inform the natural history of cirrhosis in contemporary patients with compensated cirrhosis. The LCN Definitions and Measures Committee developed criteria for the definition of cirrhosis to standardize entry into this multicenter cohort study and standardized criteria for liver-related outcome measures. This effort has produced definitions intended to be both sensitive and specific as well as easily operationalized by study staff such that outcomes critical to the LCN cohort are identified and reported in an accurate and generalizable fashion.
REGISTRATION
NCT05740358.
中文翻译:
肝硬化网络队列研究:肝硬化定义、研究人群和终点。
引言肝硬化网络 (LCN) 的主要目标之一是开展一项队列研究,以更好地了解和预测儿童 A 型肝硬化患者肝功能失代偿的风险以及其他临床和患者报告的结果。方法 LCN 由一个科学数据协调中心和 10 个临床中心组成,其研究人员遍布多个委员会。LCN 定义和测量委员会通过文献综述、专家意见和审查其他组织制定的定义文件,制定了肝硬化及其并发症的初步定义。队列委员会在指导委员会的意见下制定了研究方案。结果 LCN 开发了一项前瞻性队列研究,以描述和预测与首次失代偿和患者报告结果相关的事件临床事件的发生率。LCN 制定了代偿期肝硬化的实用定义,包括临床、实验室、影像学和组织学标准。新发和再代偿性腹水、显性肝性脑病、静脉曲张出血、门静脉胃病引起的出血和肝细胞癌的定义也被编纂成文。讨论 LCN 队列研究设计将告知当代代偿期肝硬化患者的肝硬化自然史。LCN 定义和测量委员会制定了肝硬化定义标准,以标准化进入该多中心队列研究和肝脏相关结果测量的标准化标准。 这项工作产生了旨在既敏感又特异的定义,并且易于研究人员操作,以便以准确和可推广的方式识别和报告对 LCN 队列至关重要的结果。注册NCT05740358。
更新日期:2024-07-17
中文翻译:
肝硬化网络队列研究:肝硬化定义、研究人群和终点。
引言肝硬化网络 (LCN) 的主要目标之一是开展一项队列研究,以更好地了解和预测儿童 A 型肝硬化患者肝功能失代偿的风险以及其他临床和患者报告的结果。方法 LCN 由一个科学数据协调中心和 10 个临床中心组成,其研究人员遍布多个委员会。LCN 定义和测量委员会通过文献综述、专家意见和审查其他组织制定的定义文件,制定了肝硬化及其并发症的初步定义。队列委员会在指导委员会的意见下制定了研究方案。结果 LCN 开发了一项前瞻性队列研究,以描述和预测与首次失代偿和患者报告结果相关的事件临床事件的发生率。LCN 制定了代偿期肝硬化的实用定义,包括临床、实验室、影像学和组织学标准。新发和再代偿性腹水、显性肝性脑病、静脉曲张出血、门静脉胃病引起的出血和肝细胞癌的定义也被编纂成文。讨论 LCN 队列研究设计将告知当代代偿期肝硬化患者的肝硬化自然史。LCN 定义和测量委员会制定了肝硬化定义标准,以标准化进入该多中心队列研究和肝脏相关结果测量的标准化标准。 这项工作产生了旨在既敏感又特异的定义,并且易于研究人员操作,以便以准确和可推广的方式识别和报告对 LCN 队列至关重要的结果。注册NCT05740358。