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Cited by 553

The DOI matches its Crossref record; 19 of the 19 references it cites were found in a registry or an index.

Standard Definitions and Common Data Elements for Clinical Trials in Patients With Alcoholic Hepatitis: Recommendation From the NIAAA Alcoholic Hepatitis Consortia

Open access
Crabb, David W., Bataller, Ramon, Chalasani, Naga P., Kamath, Patrick S., Lucey, Michael, Mathurin, Philippe, McClain, Craig, McCullough, Arthur, Mitchell, Mack C., Morgan, Timothy R., Nagy, Laura, Radaeva, Svetlana, Sanyal, Arun, Shah, Vijay, Szabo, Gyongyi·2016·Gastroenterology

Abstract

Heavy drinkers are at risk for a spectrum of histologic alcohol-related liver injury: steatosis, alcoholic steatohepatitis (ASH), alcohol-related fibrosis, and cirrhosis. Alcoholic hepatitis (AH), the clinical entity associated with severe ASH, has high short-term mortality. The standard-of-care therapy, prednisolone, has limited efficacy and many side effects; no other treatment has consistently shown survival benefit. The National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded Alcoholic Hepatitis Consortia carry out translational research on pathophysiologic mechanisms, genetic and environmental risk factors, phase II clinical trials, and development of biomarkers. The consortia members were convened by the National Institutes of Health to address diagnostic criteria and practical issues related to clinical AH research, and to develop a set of common data elements to harmonize ongoing and future trials. This was accomplished through 3 face-to-face meetings of the investigators and representatives of the National Institutes of Health, and subsequent electronic communications over the course of 6 months. Evidence for the recommendations was based on published trials and observational data from several of the consortia members. A draft manuscript was iteratively reviewed by members of the consortia. The goal was to reach agreements on recommendations and definitions that could facilitate trial design, and simultaneously be tested by research groups pooling their data. The recommendations made here are specifically directed to achieve better uniformity in clinical trials, rather than serving as clinical practice guidelines.

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Metadata

Authors
Crabb, D. W., Bataller, R., Chalasani, N. P., Kamath, P. S., Lucey, M., Mathurin, P., McClain, C., McCullough, A., Mitchell, M. C., Morgan, T. R., Nagy, L., Radaeva, S., Sanyal, A., Shah, V., & Szabo, G.
Venue
Gastroenterology
Publisher
Elsevier BV
Published
2016-04
Volume
150
Issue
4
Pages
785-790
ISSN
0016-5085 (ISSN-L)
OpenAlex
W2286042547
Cited by
553
References
19
FWCI
30.75
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Standard Definitions and Common Data Elements for Clinical Trials in Patients With Alcoholic Hepatitis: Recommendation From the NIAAA Alcoholic Hepatitis Consortia. https://app.cochat.ai/papers/10.1053/j.gastro.2016.02.042
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Crabb, D. W., Bataller, R., Chalasani, N. P., Kamath, P. S., Lucey, M., Mathurin, P., McClain, C., McCullough, A., Mitchell, M. C., Morgan, T. R., Nagy, L., Radaeva, S., Sanyal, A., Shah, V., & Szabo, G. (2016). Standard Definitions and Common Data Elements for Clinical Trials in Patients With Alcoholic Hepatitis: Recommendation From the NIAAA Alcoholic Hepatitis Consortia. Gastroenterology. https://doi.org/10.1053/j.gastro.2016.02.042

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.