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

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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 multidisciplinary team, scientific aims, and career development goals will not only foster Dr. Rubin's transition to a successful independent investigator and health services research leader within the field of hepatology, but also, more importantly, improve the care delivered to cirrhosis patients suffering from pain.