# Using real-world evidence to define safe pain management strategies in cirrhosis

> **NIH NIH K23** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2023 · $188,959

## Abstract

PROJECT SUMMARY / ABSTRACT
Up to 80% of patients with cirrhosis experience pain—a rate that is twice as high as in the general population.
Yet managing pain in cirrhosis patients is uniquely challenging due to provider concerns about adverse events
related to multiple classes of analgesics, which unfortunately puts these patients at risk for undertreatment of
pain. There are limited data on actual pain management strategies and analgesic-related harms in the clinically
diverse population of cirrhosis patients, and consequently, minimal evidence-based guidance on how to
appropriately treat pain in this population. The objective of the current proposal is to address this critical unmet
need by investigating real-world utilization and harms of commonly used analgesics among patients with
cirrhosis to inform the development of evidence-based guidance to support providers in managing pain in this
population. With KL2 support, Dr. Rubin has created a retrospective longitudinal cohort of >500,000 Veterans
with cirrhosis using national Veterans Health Administration (VHA) electronic health record (EHR) data. She
will leverage this cohort to achieve the following Aims: (1) Define the epidemiology of pain management, and
rates of and risk factors for analgesic-related adverse outcomes in cirrhosis; (2) Quantify the risk of major
adverse outcomes in analgesic users versus nonusers; (3) Establish guiding principles for providing evidence-
based pain management to cirrhosis patients through a Delphi consensus process. This work will provide
essential preliminary data for a future pragmatic trial to test the impact of dissemination of this guidance on both
provider practices and patient outcomes and quality-of-life. Dr. Rubin is uniquely positioned to conduct this study
as a hepatologist the at the University of California, San Francisco with experience studying clinical outcomes,
including pain and analgesic use, in cirrhosis patients using large datasets. Building upon a strong foundation
of research support, this K23 award will establish Dr. Rubin as an independent health services researcher by
providing her with formal training and experience in four essential skills for generating and translating real-
world evidence: (1) effectively leveraging large EHR-based datasets, (2) pharmacoepidemiologic analysis, (2)
causal inference methods, and (4) techniques for translating evidence into clinical practice. She has
assembled a multidisciplinary mentorship team with expertise in hepatology and clinical outcomes research
(Jennifer Lai), biostatistical and epidemiologic skills for leveraging observational data (Salomeh Keyhani), and
pain management and pre-implementation/implementation methods (Karen Seal). Her scientific advisors will
provide additional methodologic expertise in advanced biostatistical methods (Charles McCulloch), VHA-based
epidemiologic study design (Katherine Hoggatt), and Delphi consensus methods (Rebecca Sudore). The
proposed multidisciplinar...

## Key facts

- **NIH application ID:** 10808794
- **Project number:** 1K23DK135901-01A1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Jessica Rubin
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $188,959
- **Award type:** 1
- **Project period:** 2023-09-15 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10808794

## Citation

> US National Institutes of Health, RePORTER application 10808794, Using real-world evidence to define safe pain management strategies in cirrhosis (1K23DK135901-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10808794. Licensed CC0.

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