Early recognition and response to increases in surgical site infections using optimised statistical process control charts-The early 2RIS trial: A multicentre stepped wedge cluster randomised controlled trial.
Early recognition and response to increases in surgical site infections using optimised statistical process control charts-The early 2RIS trial: A multicentre stepped wedge cluster randomised controlled trial.
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DOI：
10.1016/j.eclinm.2022.101698
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发表时间：
2022-12
影响因子：
15.1
通讯作者：
Anderson, Deverick J.
中科院分区：
文献类型：
--
作者：
Baker, Arthur W.;Ilies, Iulian;Benneyan, James C.;Lokhnygina, Yuliya;Foy, Katherine R.;Lewis, Sarah S.;Wood, Brittain;Baker, Esther;Crane, Linda;Crawford, Kathryn L.;Cromer, Andrea L.;Padgette, Polly;Roach, Linda;Adcock, Linda;Nehls, Nicole;Salem, Joseph;Bratzler, Dale;Dellinger, E. Patchen;Greene, Linda R.;Huang, Susan S.;Mantyh, Christopher R.;Anderson, Deverick J.
关键词：
传统的外科手术部位感染(SSI)监测方法存在缺陷，延迟了SSI暴发的发现和其他临床上重要的SSI发生率的增加。我们调查了使用优化的统计过程控制(SPC)方法和对SSI监测的反馈是否会降低美国社区医院网络中SSI的发生率。我们在美国东南部的29家社区医院对接受了13种常见外科手术中的任何一种的患者进行了阶梯式楔形群随机试验。我们将13个程序分成六组；一家医院的一组程序是随机和分析的单位。总共有105个簇被随机分为12组，每组8-10个簇。所有参与的组在12个月的基线控制期或“传统的”SSI监测期间开始试验，包括对SSI发病率的前瞻性分析和对SSI暴发和调查的咨询支持。此后，一组集群每三个月从对照过渡到干预监测，直到所有集群都接受干预。研究统计学家的电子随机化决定了集群从控制到干预监测的顺序。干预措施是每周应用优化的SPC方法，并对现有的传统SSI监测方法进行反馈。流行病学家在判断SSI发病率增加的SPC信号时，对医院身份和随机状态视而不见，但在SSI调查期间不可能盲目。主要结果是总的SSI患病率(PR=SSIS/100过程)，通过泊松回归模型的广义估计方程进行评估。次要结果比较了确定SSI比率增加的传统和优化的SPC信号，包括产生的正式SSI调查的数量和SSI预防的最佳实践中发现的不足。这项试验在ClinicalTrials.gov，NCT03075813注册。在2016年3月1日至2020年2月29日期间，204,233名独特的患者接受了237,704例手术。148,365个程序单独接受传统的SSI监测和反馈，89,339个程序另外接受优化的SPC监测的干预。对参与组内进行的所有程序的SSI的主要结果进行了评估。接受控制监测的1171例患者(患病率为0.79/100例)发生SSI，而接受干预的781例患者(PR为0.87/100例；基于模型的PR比为1.10，95%CI为0.94-1.30，p=0.25)。传统的监测产生了24个正式的SSI调查，发现120个SSI在两个或两个以上的围手术期预防SSI的最佳实践中存在缺陷。相比之下，优化的SPC监督产生了74项正式调查，确定了458家存在多个最佳实践缺陷的SSI。在SSI监测的传统方法中加入优化的SPC方法和反馈，可以更好地发现重要的SSI比率增加和最佳实践缺陷，但不会降低SSI比率。还需要进一步的研究，以确定如何最好地利用SPC方法和反馈来提高对SSI质量措施的遵从性，并防止SSI。医疗保健研究和质量局。
Traditional approaches for surgical site infection (SSI) surveillance have deficiencies that delay detection of SSI outbreaks and other clinically important increases in SSI rates. We investigated whether use of optimised statistical process control (SPC) methods and feedback for SSI surveillance would decrease rates of SSI in a network of US community hospitals. We conducted a stepped wedge cluster randomised trial of patients who underwent any of 13 types of common surgical procedures across 29 community hospitals in the Southeastern United States. We divided the 13 procedures into six clusters; a cluster of procedures at a single hospital was the unit of randomisation and analysis. In total, 105 clusters were randomised to 12 groups of 8–10 clusters. All participating clusters began the trial in a 12-month baseline period of control or “traditional” SSI surveillance, including prospective analysis of SSI rates and consultative support for SSI outbreaks and investigations. Thereafter, a group of clusters transitioned from control to intervention surveillance every three months until all clusters received the intervention. Electronic randomisation by the study statistician determined the sequence by which clusters crossed over from control to intervention surveillance. The intervention was the addition of weekly application of optimised SPC methods and feedback to existing traditional SSI surveillance methods. Epidemiologists were blinded to hospital identity and randomisation status while adjudicating SPC signals of increased SSI rates, but blinding was not possible during SSI investigations. The primary outcome was the overall SSI prevalence rate (PR=SSIs/100 procedures), evaluated via generalised estimating equations with a Poisson regression model. Secondary outcomes compared traditional and optimised SPC signals that identified SSI rate increases, including the number of formal SSI investigations generated and deficiencies identified in best practices for SSI prevention. This trial was registered at ClinicalTrials.gov, NCT03075813. Between Mar 1, 2016, and Feb 29, 2020, 204,233 unique patients underwent 237,704 surgical procedures. 148,365 procedures received traditional SSI surveillance and feedback alone, and 89,339 procedures additionally received the intervention of optimised SPC surveillance. The primary outcome of SSI was assessed for all procedures performed within participating clusters. SSIs occurred after 1171 procedures assigned control surveillance (prevalence rate [PR] 0.79 per 100 procedures), compared to 781 procedures that received the intervention (PR 0·87 per 100 procedures; model-based PR ratio 1.10, 95% CI 0.94–1.30, p=0.25). Traditional surveillance generated 24 formal SSI investigations that identified 120 SSIs with deficiencies in two or more perioperative best practices for SSI prevention. In comparison, optimised SPC surveillance generated 74 formal investigations that identified 458 SSIs with multiple best practice deficiencies. The addition of optimised SPC methods and feedback to traditional methods for SSI surveillance led to greater detection of important SSI rate increases and best practice deficiencies but did not decrease SSI rates. Additional research is needed to determine how to best utilise SPC methods and feedback to improve adherence to SSI quality measures and prevent SSIs. Agency for Healthcare Research and Quality.
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DOI：
10.1016/j.jamcollsurg.2016.10.029
发表时间：
2017-01-01
影响因子：
5.2
作者：
Ban, Kristen A.;Minei, Joseph P.;Duane, Therese M.
通讯作者：
Duane, Therese M.
影响因子：
11.8
作者：
Gaynes, R;Richards, C;Tolson, J
通讯作者：
Tolson, J
影响因子：
5.4
作者：
Baker, Arthur W.;Nehls, Nicole;Anderson, Deverick J.
通讯作者：
Anderson, Deverick J.
影响因子：
5.4
作者：
Dyrkorn, Ole A.;Kristoffersen, Marit;Walberg, Mette
通讯作者：
Walberg, Mette
影响因子：
16.9
作者：
Hawn, Mary T.;Richman, Joshua S.;Itani, Kamal M. F.
通讯作者：
Itani, Kamal M. F.