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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.
Abstract:
The purpose of the Share 35 allocation policy was to improve liver transplant waitlist mortality, targeting high MELD waitlisted patients. However, policy changes may also have unintended consequences that must be balanced with the primary desired outcome. We performed an interrupted time series assessing the impact of Share 35 on biliary complications in a select national liver transplant population using the Vizient CDB/RM database. Liver transplants that occurred between October 2012 and September 2015 were included. There was a significant change in the incident-rate of biliary complications between Pre-Share 35 (n = 3018) and Post-Share 35 (n = 9984) cohorts over time (P = .023, r2 = .44). As a control, a subanalysis was performed throughout the same time period in Region 9 transplant centers, where a broad sharing agreement had previously been implemented. In the subanalysis, there was no change in the incident-rate of biliary complications between the two time periods. Length of stay and mean direct cost demonstrated a change after implementation of Share 35, although they did not meet statistical difference. While the target of improved waitlist mortality is of utmost importance for the equitable allocation of organs, unintended consequences of policy changes should be studied for a full assessment of a policy's impact.
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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