Department of Surgery, Division of Organ Transplantation, UMass Memorial Medical Center, University of Massachusetts, Worcester, MA; Department of Quantitative Health Sciences, Clinical and Population Health Research, University of Massachusetts Medical School, Worcester, MA; Department of Surgery, Center for Outcomes Research, University of Massachusetts Medical School, University of Massachusetts, Worcester, MA.
Department of Surgery, Division of Organ Transplantation, UMass Memorial Medical Center, University of Massachusetts, Worcester, MA.
J Am Coll Surg. 2016 Jun;222(6):1054-65. doi: 10.1016/j.jamcollsurg.2016.03.021. Epub 2016 Apr 28.
The central tenet of liver transplant organ allocation is to prioritize the sickest patients first. However, a 2007 Centers for Medicare and Medicaid Services regulatory policy, Conditions of Participation (COP), which mandates publically reported transplant center performance assessment and outcomes-based auditing, critically altered waitlist management and clinical decision making. We examine the extent to which COP implementation is associated with increased removal of the "sickest" patients from the liver transplant waitlist.
This study included 90,765 adult (aged 18 years and older) deceased donor liver transplant candidates listed at 102 transplant centers from April 2002 through December 2012 (Scientific Registry of Transplant Recipients). We quantified the effect of COP implementation on trends in waitlist removal due to illness severity and 1-year post-transplant mortality using interrupted time series segmented Poisson regression analysis.
We observed increasing trends in delisting due to illness severity in the setting of comparable demographic and clinical characteristics. Delisting abruptly increased by 16% at the time of COP implementation, and likelihood of being delisted continued to increase by 3% per quarter thereafter, without attenuation (p < 0.001). Results remained consistent after stratifying on key variables (ie, Model for End-Stage Liver Disease and age). The COP did not significantly impact 1-year post-transplant mortality (p = 0.38).
Although the 2007 Centers for Medicare and Medicaid Services COP policy was a quality initiative designed to improve patient outcomes, in reality, it failed to show beneficial effects in the liver transplant population. Patients who could potentially benefit from transplantation are increasingly being denied this lifesaving procedure while transplant mortality rates remain unaffected. Policy makers and clinicians should strive to balance candidate and recipient needs from a population-benefit perspective when designing performance metrics and during clinical decision making for patients on the waitlist.
肝移植器官分配的核心原则是优先考虑最病重的患者。然而，2007 年医疗保险和医疗补助服务中心（Centers for Medicare and Medicaid Services）的一项规定，即《参与条件》（Conditions of Participation，COP），要求公开报告移植中心的绩效评估和基于结果的审计，这一规定严重改变了等候名单的管理和临床决策。我们研究了 COP 的实施在多大程度上导致最病重的患者从肝移植等候名单中被移除。
本研究纳入了 2002 年 4 月至 2012 年 12 月（移植受者科学注册处）在 102 个移植中心登记的 90765 例成年（年龄≥18 岁）死亡供肝移植候选者。我们使用中断时间序列分段泊松回归分析来量化 COP 实施对因疾病严重程度导致的等候名单移除趋势和 1 年移植后死亡率的影响。
在具有相似人口统计学和临床特征的情况下，我们观察到因疾病严重程度而导致的除名趋势呈上升趋势。在 COP 实施时，除名突然增加了 16%，此后每季度继续增加 3%，且没有减弱（p < 0.001）。在对关键变量（即终末期肝病模型和年龄）进行分层后，结果仍然一致。COP 对 1 年移植后死亡率没有显著影响（p = 0.38）。
尽管 2007 年医疗保险和医疗补助服务中心的 COP 政策是一项旨在改善患者结局的质量倡议，但实际上，它并没有在肝移植人群中显示出有益的效果。那些可能从移植中受益的患者越来越被拒绝接受这种救命手术，而移植死亡率却没有受到影响。政策制定者和临床医生在设计绩效指标和进行等候名单上的患者临床决策时，应从人群获益的角度努力平衡候选人和受者的需求。
