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急性胰腺炎患者登记研究以检验临床经验中的新疗法(APPRENTICE):一个研究急性胰腺炎的国际多中心联盟。

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis.

作者信息

Papachristou Georgios I, Machicado Jorge D, Stevens Tyler, Goenka Mahesh Kumar, Ferreira Miguel, Gutierrez Silvia C, Singh Vikesh K, Kamal Ayesha, Gonzalez-Gonzalez Jose A, Pelaez-Luna Mario, Gulla Aiste, Zarnescu Narcis O, Triantafyllou Konstantinos, Barbu Sorin T, Easler Jeffrey, Ocampo Carlos, Capurso Gabriele, Archibugi Livia, Cote Gregory A, Lambiase Louis, Kochhar Rakesh, Chua Tiffany, Tiwari Subhash Ch, Nawaz Haq, Park Walter G, de-Madaria Enrique, Lee Peter J, Wu Bechien U, Greer Phil J, Dugum Mohannad, Koutroumpakis Efstratios, Akshintala Venkata, Gougol Amir

机构信息

Division of Gastroenterology and Hepatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA (Georgios I. Papachristou, Jorge D. Machicado, Phil J. Greer, Mohannad Dugum, Efstratios Koutroumpakis Amir Gougol).

Cleveland Clinic Foundation, Cleveland, Ohio, USA (Tyler Stevens, Tiffany Chua).

出版信息

Ann Gastroenterol. 2017;30(1):106-113. doi: 10.20524/aog.2016.0109. Epub 2016 Dec 1.

DOI:10.20524/aog.2016.0109
PMID:28042246
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5198234/
Abstract

BACKGROUND

We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials.

METHODS

The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients.

RESULTS

Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results.

CONCLUSION

APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials.

摘要

背景

我们建立了一个多中心国际联盟,以更好地了解全球急性胰腺炎(AP)的自然病史,并为未来的随机临床试验搭建一个平台。

方法

2014年7月成立了用于在临床实践中检验新疗法的急性胰腺炎患者注册研究(APPRENTICE)。随后开发了详细的基于网络的调查问卷,以前瞻性地收集急性胰腺炎患者的人口统计学、病因、胰腺炎病史、合并症、危险因素、严重程度生物标志物、严重程度指数、医疗保健利用情况、管理策略及预后等信息。

结果

在2015年11月至2016年9月期间,共有20个研究点(美国8个、欧洲5个、南美洲3个、墨西哥2个、印度2个)前瞻性地纳入了509例急性胰腺炎患者。所有数据由参与中心录入REDCap(研究电子数据采集)数据库,并由协调研究点(匹兹堡大学)进行系统审查。详细描述了研究方法和流程,以及关于人口统计学结果的中期报告。

结论

APPRENTICE,一个由全球三级急性胰腺炎中心组成的国际合作项目,已证明建立一个大型、前瞻性、多中心患者注册研究来研究急性胰腺炎是可行的。对收集到的数据进行分析可能会加深对急性胰腺炎的理解,并且APPRENTICE将作为未来随机临床试验的一个平台。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a05/5198234/14d3db288417/AnnGastroenterol-30-106-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a05/5198234/68dae0f72287/AnnGastroenterol-30-106-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a05/5198234/14d3db288417/AnnGastroenterol-30-106-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a05/5198234/68dae0f72287/AnnGastroenterol-30-106-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a05/5198234/14d3db288417/AnnGastroenterol-30-106-g002.jpg

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