Department of Surgery, University of Michigan, Ann Arbor.
Center for Healthcare Outcomes and Policy, Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor.
JAMA Surg. 2019 Nov 1;154(11):1005-1012. doi: 10.1001/jamasurg.2019.3017.
Various clinical societies and patient advocacy organizations continue to encourage minimum volume standards at hospitals that perform certain high-risk operations. Although many clinicians and quality and safety experts believe this can improve outcomes, the extent to which hospitals have responded to these discretionary standards remains unclear.
To evaluate the association between short-term clinical outcomes and hospitals' adherence to the Leapfrog Group's minimum volume standards for high-risk cancer surgery.
DESIGN, SETTING, AND PARTICIPANTS: Longitudinal cohort study using 100% of the Medicare claims for 516 392 patients undergoing pancreatic, esophageal, rectal, or lung resection for cancer between January 1, 2005, and December 31, 2016. Data were accessed between December 1, 2018, and April 30, 2019.
High-risk cancer surgery in hospitals meeting and not meeting the minimum volume standards.
Patients having surgery in hospitals meeting the volume standard and 30-day and in-hospital mortality and complication rates.
Overall, a total of 516 392 procedures (47 318 pancreatic resections, 29 812 esophageal resections, 116 383 rectal resections, and 322 879 lung resections) were included in the study, and patient mean (SD) age was 73.1 (7.5) years. Outcomes improved over time in both hospitals meeting and not meeting the minimum volume standards. Mortality after pancreatic resection decreased from 5.5% in 2005 to 4.8% in 2016 (P for trend <.001). Mortality after esophageal resection decreased from in 6.7% 2005 to 5.0% in 2016 (P for trend <.001). Mortality after rectal resection decreased from 3.6% in 2005 to 2.7 % in 2016 (P for trend <.001). Mortality after lung resection decreased from 4.2% in 2005 to 2.7 % in 2016 (P for trend <.001). Throughout the study period, there were no statistically significant differences in risk-adjusted mortality between hospitals meeting and not meeting the volume standards for esophageal, lung, and rectal cancer resections. Mortality rates after pancreatic resection were consistently lower at hospitals meeting the volume standard, although mortality at all hospitals decreased over the study period. For example, in 2016, risk-adjusted mortality rates for hospitals meeting the volume standard were 3.8% (95% CI, 3.3%-4.3%) compared with 5.7% (95% CI, 5.1%-6.5%) for hospitals that did not. Although an increasing majority of patients underwent surgery in hospitals meeting the Leapfrog volume standards over time, the overall proportion of hospitals meeting the standards in 2016 ranged from 5.6% for esophageal resection to 23.3% for pancreatic resection.
Although volume remains an important factor for patient safety, the Leapfrog Group's minimum volume standards did not differentiate hospitals based on mortality for 3 of the 4 high-risk cancer operations assessed, and few hospitals were able to meet these standards. These findings highlight important tradeoffs between setting effective volume thresholds and practical expectations for hospital adherence and patient access to centers that meet those standards.
各种临床学会和患者权益组织继续鼓励在实施某些高危手术的医院设定最低容量标准。尽管许多临床医生、质量和安全专家认为这可以改善结果,但医院对这些自由裁量标准的反应程度尚不清楚。
评估短期临床结果与医院遵守 Leapfrog 集团高危癌症手术最低容量标准之间的关系。
设计、设置和参与者:这是一项使用 2005 年 1 月 1 日至 2016 年 12 月 31 日期间接受胰腺、食管、直肠或肺癌切除术的 516392 名患者的 Medicare 索赔的 100%的回顾性队列研究。数据于 2018 年 12 月 1 日至 2019 年 4 月 30 日期间获取。
在符合和不符合最低容量标准的医院进行高危癌症手术。
在符合和不符合容量标准的医院接受手术的患者的 30 天和院内死亡率以及并发症发生率。
总的来说,共有 516392 例手术(47318 例胰腺切除术、29812 例食管切除术、116383 例直肠切除术和 322879 例肺切除术)被纳入研究,患者平均(SD)年龄为 73.1(7.5)岁。在符合和不符合最低容量标准的医院中,结果都随着时间的推移而得到改善。胰腺切除术的死亡率从 2005 年的 5.5%下降到 2016 年的 4.8%(趋势 P <.001)。食管切除术的死亡率从 2005 年的 6.7%下降到 2016 年的 5.0%(趋势 P <.001)。直肠切除术的死亡率从 2005 年的 3.6%下降到 2016 年的 2.7%(趋势 P <.001)。肺癌切除术的死亡率从 2005 年的 4.2%下降到 2016 年的 2.7%(趋势 P <.001)。在整个研究期间,在符合和不符合食管、肺和直肠癌症切除术容量标准的医院之间,没有统计学意义上的死亡率差异。然而,在符合容量标准的医院中,胰腺切除术的死亡率一直较低,尽管所有医院的死亡率在研究期间都有所下降。例如,在 2016 年,符合容量标准的医院的风险调整死亡率为 3.8%(95%CI,3.3%-4.3%),而不符合标准的医院为 5.7%(95%CI,5.1%-6.5%)。尽管随着时间的推移,越来越多的患者在符合 Leapfrog 容量标准的医院接受手术,但在 2016 年,符合标准的医院比例从食管切除术的 5.6%到胰腺切除术的 23.3%不等。
尽管容量仍然是患者安全的一个重要因素,但 Leapfrog 集团的最低容量标准并没有根据评估的 4 种高危癌症手术中的 3 种手术的死亡率来区分医院,而且很少有医院能够达到这些标准。这些发现强调了在设定有效的容量阈值和实际期望医院遵守标准以及患者获得符合这些标准的中心之间的重要权衡。