Harms of Hepatocellular Carcinoma Surveillance

Leveraging a multi-center randomized controlled trial assessing screening benefits in a
socioeconomically and racially diverse population of 3,000 patients with cirrhosis followed
in 3 healthcare settings over a 4-year period, this study aims to:

Aim 1: Assess the effect of hepatocellular carcinoma 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 hepatocellular carcinoma 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,
providers, healthcare organizations, payers, and policymakers about the value of
hepatocellular carcinoma screening in patients with cirrhosis.

Over a 4-year period, electronic medical record data will be used to compare
screening-related physical and financial harms between patients undergoing and those not
undergoing hepatocellular carcinoma screening. Psychosocial harms, as ascertained through
longitudinal measurement of validated survey instruments and qualitative interviews, will be
compared between patients with positive or indeterminate screening results and those with
negative results or without any screening. Mixed-effect regression analysis will be used to
determine if screening harms differed by factors at multiple levels including patient (e.g.
degree of liver dysfunction), provider (e.g. subspecialty training), and healthcare
organization (e.g. access to liver transplantation). This study will seamlessly complement
data from the parent randomized controlled trial. By immediately translating these high
quality data about hepatocellular carcinoma screening benefits and harms into a balance
sheet, the investigators will facilitate patient-provider discussions, inform payer decisions
about reimbursement, and guide policy decisions. These data are also crucial to identify
modifiable and high-yield intervention targets and strategies to reduce hepatocellular
carcinoma screening harms in the future.

Inclusion and exclusion criteria of the parent randomized controlled trial are as follows:

Inclusion Criteria:

- Adult patients (≥ 21 years old)

- Cirrhosis

- Outpatient visit in year prior to randomization

- English or Spanish speaking

Exclusion Criteria:

- History of hepatocellular carcinoma

- History of liver transplantation

- Child Pugh C cirrhosis

- Significant comorbid conditions with life expectancy < 1 year, (e.g., extrahepatic
malignancy)