||5R01CA212008-03 Interpret this number
||Ut Southwestern Medical Center
||Harms of Hepatocellular Carcinoma Screening in Patients with Cirrhosis
PROJECT SUMMARY / ABSTRACT
The incidence of hepatocellular carcinoma (HCC) is rising in the U.S and is projected to become the 3rd leading
cause of cancer death by 2030. Over 90% of HCC occur in cirrhosis, and HCC is the leading cause of death
for these patients. Although several professional societies recommend use of abdominal ultrasound and alpha
fetoprotein (AFP), a serum biomarker, every 6 months in patients with cirrhosis, limitations in the literature
have precluded consensus recommendations. Two systematic reviews concluded prior studies have notable
limitations including a lack of data regarding screening harms. Potential harms of HCC screening include: 1)
physical and financial harms from diagnostic evaluation in screen-positive patients (e.g., contrast injury,
radiation exposure, biopsy complications); 2) overdiagnosis; and 3) psychosocial harms due to positive or
indeterminate screen results. Because the survival benefit of HCC screening appears modest, a
comprehensive harms assessment is needed to inform guidelines, build consensus among primary care
providers and specialists, and guide patient and provider decision-making about HCC screening.
Leveraging a multi-center randomized trial assessing screening benefits in a socioeconomically (~30%
underinsured) and racially diverse (>50% Black or Hispanic) population of 3000 patients with cirrhosis
followed in 3 healthcare settings (academic tertiary care center, safety-net health system, and Veterans
Affairs system) over a 4-year period, we propose to:
Aim 1: Assess the effect of HCC screening on a) physical harms due to follow-up tests, b) financial harms, and
c) overdiagnosis in patients with severe liver dysfunction or comorbid illness, through electronic medical record
data, manual chart review, and validated survey measures
Aim 2: Assess the effect of HCC screening on screening-related psychosocial harms, e.g. cancer-specific
worry, situational anxiety, mood disturbances, and decisional regret, through longitudinal validated measures
and qualitative interviews
Aim 3: Create and disseminate a balance sheet of benefits and harms to inform patients, nurses, providers,
healthcare organizations, payers, and policymakers about the value of HCC screening in patients with cirrhosis
We will use mixed-effect regression analysis to identify if screening-related harms differ by patient, provider,
and healthcare system factors. These data will complement concurrently collected data about screening
benefits from the randomized trial to provide the highest quality data available about benefits and harms of
HCC screening at a time when policy decisions about HCC screening are being made. We will immediately
translate our study findings to facilitate patient-provider discussions, inform payer decisions about
reimbursement, and guide policy decisions on HCC screening in patients with cirrhosis.
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