Infectious Diseases Research Program and Center of Innovation in Long-term Services and Supports, Veterans Affairs Medical Center, Providence, Rhode Island, USA.
College of Pharmacy, University of Rhode Island, Kingston, Rhode Island, USA.
Pharmacoepidemiol Drug Saf. 2019 May;28(5):707-715. doi: 10.1002/pds.4761. Epub 2019 Mar 27.
As changes in antibiotic therapy are common, intent-to-treat and definitive therapy exposure definitions in infectious disease clinical trials and observational studies may not accurately reflect all antibiotics received over the course of the infection. Therefore, we sought to describe changes in antibiotic therapy and unique treatment patterns among patients with bacteremia.
We conducted a retrospective cohort study of hospitalizations from Veterans Affairs (VA) Medical Centers (January 2002-September 2015) and community hospitals (de-identified Optum Clinformatics DataMart with matched Premier Hospital data; October 2009-March 2013). In the VA population, antibiotic exposures were mapped from the culture collection date among those with positive Staphylococcus aureus cultures. In the Optum-Premier population, exposures were mapped from the admission date among those with a primary diagnosis of bacteremia.
Our study included 50 467 bacteremia admissions, with only 14% of admissions having the same treatment pattern as another admission. For every 100 bacteremia admissions, 89 had changes in antibiotic therapy. For every 100 bacteremia admissions with changes in therapy, 95 had unique antibiotic treatment patterns. These findings were consistent in both populations, over time, and among different facilities within study populations. The median time to first therapy change was 2 days after initial therapy, with a median of three changes.
Changes in antibiotic therapy for bloodstream infections were nearly universal regardless of hospital setting. Based on our findings, common antibiotic exposure definitions of intent-to-treat and definitive therapy would misclassify exposure in 86% of admissions, which highlights the need for better operational definitions of exposure in infectious diseases research.
由于抗生素治疗方案经常发生变化,因此在感染病临床试验和观察性研究中,按意向治疗(intention-to-treat)和确定治疗(definitive therapy)定义的暴露情况可能无法准确反映感染过程中接受的所有抗生素。因此,我们旨在描述菌血症患者的抗生素治疗方案变化和独特的治疗模式。
我们进行了一项回顾性队列研究,纳入了退伍军人事务部(VA)医疗中心(2002 年 1 月至 2015 年 9 月)和社区医院(去识别 Optum Clinformatics DataMart 与 Premier 医院匹配数据;2009 年 10 月至 2013 年 3 月)的住院患者。在 VA 人群中,对金黄色葡萄球菌培养阳性患者的培养采集日期进行抗生素暴露情况映射。在 Optum-Premier 人群中,对主要诊断为菌血症的患者,根据入院日期进行暴露情况映射。
我们的研究纳入了 50467 例菌血症入院患者,只有 14%的入院患者与另一次入院患者的治疗方案相同。每 100 例菌血症入院中,有 89 例发生了抗生素治疗方案变化。每 100 例治疗方案变化的菌血症患者中,有 95 例存在独特的抗生素治疗模式。这些发现无论在医院设置、时间推移还是在研究人群内的不同机构中都具有一致性。首次治疗方案变化的中位时间为初始治疗后 2 天,中位变化次数为 3 次。
无论医院环境如何,血流感染的抗生素治疗方案变化几乎普遍存在。根据我们的研究结果,按意向治疗和确定治疗的常见抗生素暴露定义会使 86%的入院患者的暴露情况分类错误,这突显了在感染病研究中需要更好地定义暴露的操作性定义。