Browsing by Author "McClain, Craig"

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    Parental liver disease mortality is associated with unfavorable outcomes in patients with alcohol-associated hepatitis
    (Wolters Kluwer, 2025-05-23) Tu, Wanzhu; Gawrieh, Samer; Nephew, Lauren; McClain, Craig; Tang, Qing; Dasarathy, Srinivasan; Vatsalya, Vatsalya; Simonetto, Douglas A.; Kettler, Carla; Szabo, Gyongyi; Barton, Bruce; Yu, Yunpeng; Kamath, Patrick S.; Sanyal, Arun J.; Nagy, Laura; Mitchell, Mack C.; Liangpunsakul, Suthat; Shah, Vijay H.; Chalasani, Naga; Bataller, Ramon; AlcHepNet Investigators; Medicine, School of Medicine
    Background: How parental alcohol use disorder and liver disease-related mortality influence the risk and the outcomes of alcohol-associated hepatitis (AH) in the offspring is unknown. Methods: We analyzed data from 2 prospective observational studies of AH cases and heavy drinking controls (HDCs). Family history of parental alcohol use disorder and liver disease mortality was assessed at the study entry. Logistic regression and Cox proportional hazard models were used to assess the influences of family history on AH development and outcome. Results: Data from 1356 participants in two prospective cohorts (926 AH cases and 430 HDC) were combined and analyzed. Parental alcohol use disorder was found in 56.9% of AH cases and 61.1% of HDC; parental death due to liver disease was reported in 7.5% of AH cases and 5.7% of HDC. Multivariable logistic regression showed that parental liver disease-related mortality was associated with more than a doubled risk of AH development in the offspring after controlling for their demographic characteristics and drinking behavior (OR=2.26, 95% CI: [1.22, 4.20]). Moreover, among the AH cases, having a parent die of liver disease significantly increased the 90-day mortality of study participants after adjusting for the effects of other risk factors (HR=2.26, 95% CI: [1.05, 4.86]). Conclusions: The study highlights the influences of parental death due to liver disease on AH development and mortality. Identifying patients at risk of AH through family history might help facilitate discussions on reducing alcohol consumption.
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    Research methodologies to address clinical unmet needs and challenges in alcohol-associated liver disease
    (Wolters Kluwer, 2022) Singal, Ashwani K.; Kwo, Paul; Kwong, Allison; Liangpunsakul, Suthat; Louvet, Alexandre; Mandrekar, Pranoti; McClain, Craig; Mellinger, Jessica; Szabo, Gyongyi; Terrault, Norah; Thursz, Mark; Winder, Gerald S.; Kim, W. Ray; Shah, Vijay H.; Medicine, School of Medicine
    Alcohol-associated liver disease (ALD) is emerging worldwide as the leading cause of liver-related morbidity, mortality, and indication for liver transplantation. The ALD Special Interest Group and the Clinical Research Committee at the digital American Association for the Study of Liver Diseases meeting in November 2020 held the scientific sessions to identify clinical unmet needs in ALD, and addressing these needs using clinical research methodologies. Of several research methodologies, the sessions were focused on (a) studying disease burden of ALD using large administrative databases, (b) developing biomarkers for noninvasive diagnosis of alcohol-associated hepatitis (AH) and estimation of disease prognosis, (c) identifying therapeutic targets for ALD and AH, (d) deriving accurate models to predict prognosis or posttransplant alcohol relapse as a basis for developing treatment algorithm and a uniform protocol on patient-selection criteria for liver transplantation, and (e) examining qualitative research methodologies in studying the barriers to implementation of multidisciplinary integrated care model by hepatology and addiction teams for the management of dual pathology of liver disease and of alcohol use disorder. Prospective multicenter studies are required to address many of these clinical unmet needs. Further, multidisciplinary care models are needed to improve long-term outcomes in patients with ALD.
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    Standard Definitions and Common Data Elements for Clinical Trials in Patients With Alcoholic Hepatitis: Recommendation From the NIAAA Alcoholic Hepatitis Consortia
    (Elsevier, 2016-04) Crabb, David W.; Bataller, Naga; Chalasani, Naga P.; Kamath, Patrick S.; Lucey, Michael; Mathurin, Philippe; McClain, Craig; McCullough, Arthur; Mitchell, Mack C.; Morgan, Timothy R.; Department of Medicine, IU School of Medicine
    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.