Comparative Effectiveness and Cost of Surgical Prophylaxis Regimens

描述（由申请人提供）： 医疗获得性感染（HAI）近年来受到了极大的关注。在联邦和州一级颁布了越来越多的任务，以强制执行HAI预防战略，现在有相当多的资源用于支持这些战略，但没有一个明确的模板来评估其临床和经济后果。手术部位感染（SSI）是最常见的HAI之一，并导致显著的发病率、死亡率和医疗保健成本。使用针对皮肤微生物的预防性抗生素是预防SSI的标准护理过程。耐甲氧西林的S.金黄色葡萄球菌（MRSA）携带使使用β-内酰胺（例如头孢菌素）进行抗微生物预防的传统方法复杂化，因为其对MRSA不起作用。在已知有MRSA定植或感染的患者中，推荐万古霉素用于手术预防。然而，尚不清楚万古霉素是否应单独使用或与内酰胺类药物联合使用。单独使用万古霉素作为手术预防有明显的缺点，包括不能预防革兰氏阴性菌（如E。大肠杆菌）感染和选择万古霉素抗性。MRSA筛查导向万古霉素手术预防与通用万古霉素用于高风险手术的比较和成本效益也尚未确定。因此，在充分了解SSI预防政策和最佳做法方面存在重大差距。这项建议的主要目的包括：1）进行回顾性队列研究以确定经历外科手术的MRSA阳性和MRSA阴性患者中SSI的风险，通过手术预防方案和其他风险因素（例如年龄、手术类型、和阿萨分类，以检验预-手术鼻MRSA状态是万古霉素手术预防和SSI风险之间相关性的影响因素; 2）评价万古霉素单独与万古霉素加α-内酰胺作为手术预防性治疗在预防SSI方面的比较有效性，以检验联合方案比万古霉素单独更有效预防SSI的假设;和3）评价术前筛查后直接万古霉素手术预防与通用万古霉素用于高风险手术的比较和成本效益，以检验以下假设： 与通用万古霉素手术预防相比，筛选导向的手术预防取决于筛选人群中MRSA的患病率。我们将利用现有的国家VA数据库对接受手术的患者进行回顾性队列研究，这些患者通过手术护理改善项目的外部同行评审计划（EPRP）评估特定的性能指标。我们将使用回归和马尔可夫模型来评估MRSA筛查导向的手术预防方法和方案的相对有效性和成本效益。调查结果将与MRSA预防倡议计划办公室协调实施。

DESCRIPTION (provided by applicant): Project Summary/Abstract Healthcare-acquired infections (HAIs) have received significant attention in recent years. An increasing number of mandates have been enacted at the federal and state levels to force the implementation of HAI-prevention strategies, and considerable resources are now devoted to supporting them without a clear template for how to evaluate their clinical and economic ramifications. Surgical site infections (SSI) are among the most common HAIs and result in significant morbidity, mortality, and health care costs. Use of prophylactic antibiotics directed against skin organisms is a standard of care process for preventing SSI. An increasing prevalence of methicillin-resistant S. aureus (MRSA) carriage has complicated the traditional approach of using a ¿-lactam (e.g. cephalosporin) for antimicrobial prophylaxis because it does not work against MRSA. In patients known to have MRSA colonization or infection, vancomycin is recommended for surgical prophylaxis. However, it is not clear whether vancomycin should be used alone or in addition to a ¿-lactam drug. The use of vancomycin alone as surgical prophylaxis has significant downsides, including inability to prevent Gram-negative (e.g. E. coli) infections and selecting for vancomycin resistance. The comparative and cost effectiveness of MRSA screening-directed vancomycin surgical prophylaxis vs. universal vancomycin for high- risk surgeries has also not been established. Thus, there are critical gaps in knowledge to fully inform policies and best practices for SSI prevention. The main aims of this proposal include: 1) Conduct a retrospective cohort study to determine the risk of SSI in MRSA positive and MRSA negative patients undergoing surgical procedures, stratified by surgical prophylaxis regimen and other risk factors such as age, type of surgery, and ASA classification to test the hypothesis that pre-operative nasal MRSA status is an effect modifier of the association between receipt of vancomycin surgical prophylaxis and SSI risk; 2) Evaluate the comparative effectiveness of vancomycin alone vs. vancomycin plus a ¿-lactam as surgical prophylaxis in prevention of SSI to test the hypothesis that the combination regimen is more effective in preventing SSI than vancomycin alone; and 3) Evaluate the comparative and cost-effectiveness of pre-operative screening followed by directed vancomycin surgical prophylaxis vs. universal vancomycin for high-risk surgeries to test the hypothesis that the cost efficiency of screening-directed surgical prophylaxis compared to universal vancomycin surgical prophylaxis depends on the MRSA prevalence in the screened population. We will utilize existing national VA databases to conduct a retrospective cohort study of patients undergoing surgeries that are assessed for specific performance measures by the Surgical Care Improvement Project's External Peer Review Program (EPRP). We will use regression and Markov modeling to evaluate comparative effectiveness and cost-effectiveness of MRSA- screening directed surgical prophylaxis approaches and regimens. The findings will be implemented in coordination with the MRSA Prevention Initiative Program Office.