Harms of Hepatocellular Carcinoma Surveillance

Arms (1)

1. label

   Cohort

   description

   This study will collect prospective longitudinal data to characterize rates and identify correlates of a) physical harms due to follow-up tests, b) financial harms, and c) inappropriate screening using electronic medical record data and manual chart review. The study will also use surveys and semi-structured interviews to characterize rates and identify correlates of screening-related psychological harms, e.g. cancer specific worry, situational anxiety, mood disturbances, and decisional regret. Lastly, investigators will create and disseminate a balance sheet of benefits and harms to inform patients, providers, healthcare organizations, payers, and policymakers about the role of hepatocellular carcinoma screening in patients with cirrhosis.

   interventionNames

   1. Other: Prospective Longitudinal Data
   2. Other: Surveys and Semi-structured Interviews

Primary outcomes (4)

1. measure

   Physical Harms

   timeFrame

   4 Years

   description

   Physical harms (contrast injury, radiation exposure, and biopsy complications) can result from screening or follow-up testing and extends beyond medical complications to include discomfort. A binary outcome (harm vs. no harm) will be defined for each person and each type of physical harm (contrast injury, radiation exposure, biopsy, and any physical harm). We will report the point estimate and 95% confidence interval for the proportion of patients with each type of harm in each arm, stratified by health system. Using an intention-to-treat principle, we will use Chi squared test to compare the proportion of patients with physical harms between the screening and usual care arms, with a secondary analysis stratified by health system. We will also perform a sensitivity analysis based on test intent, in which we will only include tests (and corresponding harms) performed as a direct result of hepatocellular carcinoma screening.