Rogers Chris A, Ganesh J Saravana, Banner Nicholas R, Bonser Robert S
UK Cardiothoracic Transplant Audit, Clinical Effectiveness Unit, The Royal College of Surgeons of England, 35-43 Lincoln's Inn Fields, London WC2A 3PE, UK.
Eur J Cardiothorac Surg. 2005 Jun;27(6):1022-9. doi: 10.1016/j.ejcts.2005.02.033. Epub 2005 Apr 8.
Guidelines are needed for real-time quality monitoring in heart and lung transplantation. The cumulative sum (CUSUM) methodology with boundary limits derived from the sequential probability ratio test (SPRT) provide a means of monitoring performance without the need for repeated statistical testing. The variable life adjusted display (VLAD) complements the SPRT chart and provides a directly interpretable assessment of performance. We present our experience with these charts in monitoring cardiothoracic transplant outcomes in the UK.
Thirty-day-post-transplantation mortality after isolated first time transplantation of the heart (n=1634) or lung (n=1162) in adults, between July 1995 and March 2004 in eight centres were monitored. CUSUM charts, with and without risk-adjustment and risk-adjusted VLAD plots were constructed. Thirty-day mortality rates for the UK as a whole were taken as the reference values for the unadjusted charts and a 50% increase in risk provided the basis for construction of boundary lines for the SPRT. Risk-adjustment was based on multivariate models previously developed from the national database.
For heart transplantation without risk-adjustment, four centres crossed the lower boundary, indicating 30-day mortality was in-line with or better than seen nationally. Two centres were close to signalling an alert, warning of a rise in mortality rate, but neither chart signalled an alarm. After risk-adjustment one centre's graph moved towards the centre of the chart, indicating monitoring should continue and the other signalled an alarm. For lung transplantation the unadjusted mortality rate at one centre was confirmed acceptable and the results remained inconclusive for five. At the other centre, following an alert to a possible increase in mortality half-way through the sequence, results improved. Case-mix adjustment served to pull the charts away from the upper boundary lines; no chart suggested any cause for concern. For most centres the VLAD charts oscillated around the horizontal axis.
CUSUM charts are useful tools for monitoring performance, and provide a basis for visually comparing results between centres and identifying periods of 'bad runs'. Risk-adjustment, which down-weights higher risk activity, avoids inappropriate reaction to unadjusted breaches of alert and alarm lines.
心脏和肺移植的实时质量监测需要指南。采用源自序贯概率比检验(SPRT)的边界限制的累积和(CUSUM)方法提供了一种无需重复统计检验即可监测性能的手段。可变寿命调整显示(VLAD)对SPRT图表起到补充作用,并提供了对性能的直接可解释评估。我们介绍了我们在英国使用这些图表监测心胸移植结果的经验。
对1995年7月至2004年3月期间八个中心的成人首次单独进行心脏移植(n = 1634)或肺移植(n = 1162)后30天的死亡率进行监测。构建了有和没有风险调整的CUSUM图表以及风险调整后的VLAD图。将英国整体的30天死亡率作为未调整图表的参考值,并将风险增加50%作为构建SPRT边界线的基础。风险调整基于先前从国家数据库开发的多变量模型。
对于未进行风险调整的心脏移植,四个中心越过了下边界,表明30天死亡率与全国水平相当或更好。两个中心接近发出警报,提示死亡率上升,但两个图表均未发出警报。进行风险调整后,一个中心的图表向图表中心移动,表明监测应继续,另一个则发出了警报。对于肺移植,一个中心的未调整死亡率被确认为可接受,五个中心的结果仍无定论。在另一个中心,在序列进行到一半时发出可能死亡率增加的警报后,结果有所改善。病例组合调整使图表远离上边界线;没有图表显示有任何值得担忧的原因。对于大多数中心,VLAD图表围绕水平轴振荡。
CUSUM图表是监测性能的有用工具,并为直观比较各中心结果以及识别“不佳时期”提供了基础。风险调整降低了高风险活动的权重,避免了对未调整的警报和报警线突破做出不适当的反应。