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Review
. 2024 Mar 1;79(3):704-712.
doi: 10.1097/HEP.0000000000000345. Epub 2023 Feb 27.

Implementing pragmatic clinical trials in hepatology

Elliot B Tapper  1 , Marina Serper  2 , David S Goldberg  3
Affiliations
Review

Implementing pragmatic clinical trials in hepatology

Elliot B Tapper et al. Hepatology. .

Abstract

Patients with chronic liver disease would benefit from pragmatic trial designs. A pragmatic trial seeks to inform clinical decision-making by providing evidence for the adoption of an intervention into real-world clinical practice. A trial's pragmatism is based on the efficiency by which it identifies, recruits, and follows patients, the degree to which the interventions and design mirror the usual clinical care, and the importance of the outcomes to the patients. We review the promise, trade-offs, and purpose of pragmatic trials in hepatology.

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Conflict of interest statement

Tapper has consulted for Bausch, Mallinckrodt, Axcella, Novo Nordisk, Ambys, Lipocine, Kaleido, Takeda.

Goldberg: Research grant support paid to my institution from Gilead and AbbVie

Serper: Research grant support paid to my institution from Grifols

Figures

Figure 1:
Figure 1:. Elements of Pragmatic trials.
The domains of pragmatism as assessed by the PRECIS-2 tool.
See this image and copyright information in PMC

References

    1. Moon AM, Singal AG, Tapper EB. Contemporary Epidemiology of Chronic Liver Disease and Cirrhosis. Clinical Gastroenterology and Hepatology 2019. - PMC - PubMed
    1. Asrani SK, Hall L, Hagan M, Sharma S, Yeramaneni S, Trotter J, Talwalkar J, et al. Trends in Chronic Liver Disease-Related Hospitalizations: A Population-Based Study. Am J Gastroenterol 2019;114:98–106. - PubMed
    1. Tapper E, Kanwal F, Asrani S, Ho C, Ovchinsky N, Poterucha J, Flores A, et al. Patient Reported Outcomes in Cirrhosis: A Scoping Review of the Literature. Hepatology (Baltimore, Md.) 2017. - PubMed
    1. Villanueva C, Albillos A, Genescà J, Garcia-Pagan JC, Calleja JL, Aracil C, Bañares R, et al. β blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. The Lancet 2019;393:1597–1608. - PubMed
    1. Tapper EB, Parikh ND. The Future of Quality Improvement for Cirrhosis. Liver Transpl 2021. - PMC - PubMed

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