Original Investigation 

Association Between State-Mandated Protocolized Sepsis Care and In-hospital Mortality Among Adults With Sepsis

Jeremy M. Kahn, Billie S. Davis, Jonathan G. Yabes, et al

JAMA. 2019;322(3):240-250. doi:10.1001/jama.2019.9021

Abstract

Importance 背景

Beginning in 2013, New York State implemented regulations mandating that hospitals implement evidence-based protocols for sepsis management, as well as report data on protocol adherence and clinical outcomes to the state government. The association between these mandates and sepsis outcomes is unknown.

纽约州自2013年发布规定，要求医院实施针对脓毒症的循证诊疗方案，同时需要向州政府报告方案依从性及临床预后。这些要求与脓毒症预后的相关性尚不清楚。

Objective 目的

To evaluate the association between New York State sepsis regulations and the outcomes of patients hospitalized with sepsis.

评价纽约州脓毒症规定与脓毒症住院患者预后的相关性。

Design, Setting, and Participants 设计，场景和研究对象

Retrospective cohort study of adult patients hospitalized with sepsis in New York State and in 4 control states (Florida, Maryland, Massachusetts, and New Jersey) using all-payer hospital discharge data (January 1, 2011-September 30, 2015) and a comparative interrupted time series analytic approach.

采用医院出院患者数据（2011年1月1日至2015年9月30日）及间断时间序列比较分析方法，对纽约州和4个对照州（佛罗里达，马里兰，马萨诸塞和新泽西）罹患脓毒症的成年住院患者进行的回顾性队列研究

Exposures 暴露因素

Hospitalization for sepsis before (January 1, 2011-March 31, 2013) vs after (April 1, 2013-September 30, 2015) implementation of the 2013 New York State sepsis regulations.

在2013年纽约州脓毒症规定实施前（2011年1月至2013年3月31日）与实施后（2013年4月1日至2015年9月30日）脓毒症住院患者。

Main Outcomes and Measures 主要预后指标

The primary outcome was 30-day in-hospital mortality. Secondary outcomes were intensive care unit admission rates, central venous catheter use, Clostridium difficile infection rates, and hospital length of stay.

主要预后指标位30天住院病死率。次要预后指标包括收入ICU比例，中心静脉导管使用，难辨梭状芽孢杆菌感染率及住院日。

Results 结果

The final analysis included 1 012 410 sepsis admissions to 509 hospitals. The mean age was 69.5 years (SD, 16.4 years) and 47.9% were female. In New York State and in the control states, 139 019 and 289 225 patients, respectively, were admitted before implementation of the sepsis regulations and 186 767 and 397 399 patients, respectively, were admitted after implementation of the sepsis regulations. Unadjusted 30-day in-hospital mortality was 26.3% in New York State and 22.0% in the control states before the regulations, and was 22.0% in New York State and 19.1% in the control states after the regulations. Adjusting for patient and hospital characteristics as well as preregulation temporal trends and season, mortality after implementation of the regulations decreased significantly in New York State relative to the control states (P = .02 for the joint test of the comparative interrupted time series estimates). For example, by the 10th quarter after implementation of the regulations, adjusted absolute mortality was 3.2% (95% CI, 1.0% to 5.4%) lower than expected in New York State relative to the control states (P = .004). The regulations were associated with no significant differences in intensive care unit admission rates (P = .09) (10th quarter adjusted difference, 2.8% [95% CI, −1.7% to 7.2%], P = .22), a significant relative decrease in hospital length of stay (P = .04) (10th quarter adjusted difference, 0.50 days [95% CI, −0.47 to 1.47 days], P = .31), a significant relative decrease in the C difficile infection rate (P < .001) (10th quarter adjusted difference, −1.8% [95% CI, −2.6% to −1.0%], P < .001), and a significant relative increase in central venous catheter use (P = .02) (10th quarter adjusted difference, 4.8% [95% CI, 2.3% to 7.4%], P < .001).

最终分析纳入509家医院收治的 1, 012, 41 名脓毒症住院患者。平均年龄为 69.5 岁 (SD, 16.4 岁) ，47.9% 为女性。在纽约州和对照各州，分别有 139 019 名和 289 225 名患者在实施脓毒症规定前入院， 186 767 名和 397 399 名患者在规定实施后入院。在规定实施前，纽约州患者未校正30天住院病死率为 26.3%，对照各州为 22.0%，规定实施后纽约州为 22.0%，对照各州为 19.1% 。根据患者和医院特征以及规定前时间趋势和季节进行校正后，规定实施后，与对照各州相比，纽约州患者病死率显著降低（间断时间序列分析的综合检验P = .02）。例如，规定实施后第10个季度，与对照各州相比，纽约州患者校正后绝对病死率较预期降低 3.2% (95% CI, 1.0% to 5.4%) (P = .004)。实施规定与收住ICU比例 (P = .09)（第10个季度校正后差异，2.8% [95% CI, −1.7% to 7.2%], P = .22）无关，伴随住院日显著降低 (P = .04)（第10个季度校正后差异，0.50 天 [95% CI, −0.47 to 1.47 天], P = .31），难辨梭状芽孢杆菌感染率显著降低 (P < .001)（第10个季度校正后差异，−1.8% [95% CI, −2.6% to −1.0%], P < .001），以及中心静脉导管使用率显著增加 (P = .02)（第10个季度校正后差异， 4.8% [95% CI, 2.3% to 7.4%], P < .001）。

Conclusions and Relevance 结论与意义

In New York State, mandated protocolized sepsis care was associated with a greater decrease in sepsis mortality compared with sepsis mortality in control states that did not implement sepsis regulations. Because baseline mortality rates differed between New York and comparison states, it is uncertain whether these findings are generalizable to other states.

与未实施脓毒症规定的各州相比，纽约州针对脓毒症的强制性方案化诊疗伴随脓毒症病死率更明显降低。由于纽约州和对照各州的基线病死率差异较大，尚不明确这一发现能否推广到其他州。

评论[仅代表个人观点]

• 队列研究不能作为实施政策的充分证据
• 围绕SEP-1展开的争论（请参看2天后的述评）及种种态度改变引发思考
• 将某种指标用于反映ICU的质量，即使在实施后也应当有数据评估
• 有趣也关键的问题在于，如何得到反映质量的指标？目前，国内各个质控中心都采用自己上报的方式。其实可以看看，多数ICU自行上报的质控指标是不是都特别优秀？