The effect of Share 35 on biliary complications: An interrupted time series analysis

J N Fleming1, D J Taber2,3, D Axelrod4

  • 1Department of Pharmacy Services, Medical University of South Carolina, Charleston, SC, USA.

Insights

The Share 35 organ allocation policy, designed to reduce liver transplant waitlist deaths, was associated with a significant increase in biliary complications. Further study is needed to balance policy goals with potential unintended consequences.

Area of Science:

  • Hepatology
  • Transplant Surgery
  • Health Policy Analysis

Background:

  • The Share 35 policy aimed to improve liver transplant waitlist mortality by prioritizing high Model for End-Stage Liver Disease (MELD) patients.
  • Policy implementation can lead to unforeseen outcomes that require careful evaluation alongside primary objectives.

Purpose of the Study:

  • To assess the impact of the Share 35 allocation policy on the incidence of biliary complications in liver transplant recipients.
  • To identify potential unintended consequences of the Share 35 policy.

Main Methods:

  • An interrupted time series analysis was conducted using the Vizient CDB/RM database.
  • Liver transplants performed between October 2012 and September 2015 were included, comparing pre- and post-Share 35 cohorts.
  • A subanalysis in Region 9 transplant centers with a prior broad sharing agreement served as a control.

Main Results:

  • A significant increase in the incident rate of biliary complications was observed after the implementation of Share 35 (P = .023).
  • The control group in Region 9 showed no significant change in biliary complication rates.
  • Post-policy changes in length of stay and direct costs were noted but did not reach statistical significance.

Conclusions:

  • The Share 35 policy, while targeting improved waitlist mortality, was associated with an increased incidence of biliary complications.
  • Unintended consequences, such as changes in complication rates, must be considered for a comprehensive assessment of organ allocation policies.
  • Further research is warranted to fully understand and mitigate the adverse effects of organ allocation policy changes.

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