Disparate outcomes in Hispanic patients with metabolic dysfunction-associated steatotic liver disease/steatohepatitis and type 2 diabetes: Large cohort study
Joseph Matthew Gosnell, George Golovko, Esteban Arroyave, Akshata Moghe, Michael L Kueht, Omar Abdul Saldarriaga, Kevin H McKinney, Heather L Stevenson, Monique R Ferguson
Joseph Matthew Gosnell, Esteban Arroyave, Heather L Stevenson, Department of Pathology, University of Texas Medical Branch, Galveston, TX 77555, United States
George Golovko, Department of Pharmacology & Toxicology, University of Texas Medical Branch, Galveston, TX 77555, United States
Akshata Moghe, Department of Medicine, University of Texas Health Science Center at Houston, Houston, TX 77030, United States
Michael L Kueht, Department of Surgery, University of Texas Medical Branch, Galveston, TX 77555, United States
Omar Abdul Saldarriaga, Center for Tropical Diseases, Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX 77555, United States
Kevin H McKinney, Monique R Ferguson, Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX 77555, United States
Co-corresponding authors: Joseph Matthew Gosnell and Monique R Ferguson.
Author contributions: Gosnell JM and Ferguson MR contributed equally to this publication and are co-corresponding authors. Gosnell JM, Moghe A, Stevenson HL, and Ferguson MR conceptualized the study; Gosnell JM, Golovko G, and Ferguson MR constructed the research methodology, and were responsible for study and result validation; Golovko G was responsible for software optimization, provided resources and data curation via TriNetX, and assisted in securing funding; Gosnell JM, Golovko G, Arroyave E, and Ferguson MR performed the formal analysis and worked on data/result visualization; Gosnell JM and Ferguson MR performed investigation of results, and were responsible for supervising the manuscript; Gosnell JM, Arroyave E, and Ferguson MR wrote the original draft; Gosnell JM, Golovko G, Arroyave E, Moghe A, Kueht ML, Saldarriaga OA, McKinney KH, Stevenson HL, and Ferguson, MR assisted in reviewing and editing the manuscript; Gosnell JM, Stevenson HL, and Ferguson MR administrated the project.
Supported by Institute for Translational Sciences at the University of Texas Medical Branch, supported in part by a Clinical and Translational Science Award from the National Center for Advancing Translational Sciences at the National Institutes of Health, UL1TR001439; and Moody Endowment Grant, 2014-07.
Institutional review board statement: DATE: August 23, 2023 TO: UTMB Researcher FROM: Anne Clark, BA, CIP Director, Human Research Protection Program RE: IRB Acknowledgement of Not Human Subject Research Title: Secondary Analysis of data from TriNetX Utilization of data from the TriNetX database UTMB IRB 20-0085 titled Deidentified Collections of Electronical Medical Records For Internal(I2B2) and External (TriNetX) Access does not require UTMB IRB review as it is secondary analysis of existing data, does not involve intervention or interaction with human subjects an is de-identified per the de-identification standard defined in Section 164.512(a) of the HPAA Privacy Rule. The process by which the data is de-identified is attested to through a formal determination by a qualified expert as defined in Section 164.514(b)(1). Therefore, the data does not meet the definition of a human subject as outlined at 45 CFR 46.102 and is deemed not human subject research which does not require IRB review and/or approval. If you have any questions related to this project or the IRB, you may telephone me, at 409-266-9434.
Informed consent statement: Consent was not obtained but the presented data are anonymized and risk of identification is low.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Joseph Matthew Gosnell, MD, MS, Doctor, Department of Pathology, University of Texas Medical Branch, 301 University Blvd, Galveston, TX 77555, United States.
jogosnel@utmb.edu
Received: December 12, 2023
Peer-review started: December 12, 2023
First decision: December 25, 2023
Revised: January 9, 2024
Accepted: March 6, 2024
Article in press: March 6, 2024
Published online: May 15, 2024
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