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社区医院核心抗菌药物管理干预措施的可行性。

Feasibility of Core Antimicrobial Stewardship Interventions in Community Hospitals.

机构信息

Duke Center for Antimicrobial Stewardship and Infection Prevention, Division of Infectious Diseases, Duke University School of Medicine, Durham, North Carolina.

Duke Clinical Research Institute, Durham, North Carolina.

出版信息

JAMA Netw Open. 2019 Aug 2;2(8):e199369. doi: 10.1001/jamanetworkopen.2019.9369.

Abstract

IMPORTANCE

The feasibility of core Infectious Diseases Society of America-recommended antimicrobial stewardship interventions in community hospitals is unknown.

OBJECTIVE

To determine the feasibility and results of implementing 2 core stewardship intervention strategies in community hospitals.

DESIGN, SETTING, AND PARTICIPANTS: Three-stage, multicenter, prospective nonrandomized clinical trial with crossover design. The setting was 4 community hospitals in North Carolina (median bed size, 305; range, 102-425). Participants were all patients receiving targeted study antibacterial agents or alternative, nonstudy antibacterial agents. The study dates were October 2014 through October 2015. All statistical analyses were completed as of October 2016.

INTERVENTIONS

Two antimicrobial stewardship strategies targeted vancomycin hydrochloride, piperacillin-tazobactam, and the antipseudomonal carbapenems on formulary at the study hospitals: (1) modified preauthorization (PA), in which the prescriber had to receive pharmacist approval for continued use of the antibiotic after the first dose, and (2) postprescription audit and review (PPR), in which the pharmacist would engage the prescriber about antibiotic appropriateness after 72 hours of therapy. Two hospitals performed modified PA for 6 months, then PPR for 6 months after a 1-month washout. The other 2 hospitals performed the reverse.

MAIN OUTCOMES AND MEASURES

The primary outcome was the feasibility of implementing the interventions, determined by (1) approval by hospital administration and committees at each study hospital; (2) completion of pharmacist training; (3) initiation and implementation as determined by number, type, and outcomes of interventions performed; and (4) time required for interventions. Secondary outcomes included antimicrobial use (days of therapy) compared with matched historical periods and length of hospitalization.

RESULTS

A total of 2692 patients (median age, 65 years; interquartile range, 53-76 years) underwent a study intervention; 1413 (52.5%) were female, 1323 (49.1%) were white, and 1047 (38.9%) were African American. Intervention approvals took a median of 95 days (range, 56-119 days); during these discussions, strict PA was deemed not feasible. Instead, the modified PA intervention was used throughout the study. Pharmacists performed 1456 modified PA interventions (median per hospital, 350 [range, 129-628]) and 1236 PPR interventions (median per hospital, 298 [range, 273-366]). Study antimicrobials were determined to be inappropriate 2 times as often during the PPR period (41.0% [435 of 1060] vs 20.4% [253 of 1243]; P < .001). Pharmacists recommended dose change more often during the modified PA intervention (15.9% [232 of 1456] vs 9.6% [119 of 1236]; P < .001) and de-escalation during PPR (29.1% [360 of 1236] vs 13.0% [190 of 1456]; P < .001). The median time dedicated to the stewardship interventions varied by hospital (range of median hours per week, 5-19). Overall antibiotic use decreased during PPR compared with historical controls (mean [SD] days of therapy per 1000 patient-days, 925.2 [109.8] vs 965.3 [109.4]; mean difference, -40.1; 95% CI, -71.7 to -8.6), but not during modified PA (mean [SD] days of therapy per 1000 patient-days, 931.0 [102.0] vs 926.6 [89.7]; mean difference, 4.4; 95% CI, -55.8 to 64.7).

CONCLUSIONS AND RELEVANCE

Strict PA was not feasible in the study hospitals. In contrast, PPR was a feasible and effective strategy for antimicrobial stewardship in settings with limited resources and expertise.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02212808.

摘要

重要性:核心传染病学会推荐的抗菌药物管理干预措施在社区医院实施的可行性尚不清楚。

目的:确定在社区医院实施 2 项核心管理干预策略的可行性和结果。

设计、地点和参与者:三阶段、多中心、前瞻性非随机临床试验,采用交叉设计。该研究地点为北卡罗来纳州的 4 家社区医院(中位床位数为 305 张;范围为 102-425 张)。参与者均为接受目标研究抗菌药物或替代非研究抗菌药物的患者。研究日期为 2014 年 10 月至 2015 年 10 月。所有的统计分析均于 2016 年 10 月完成。

干预措施:针对研究医院处方集中的盐酸万古霉素、哌拉西林他唑巴坦和抗假单胞菌碳青霉烯类药物,实施了 2 项抗菌药物管理策略:(1)改良预授权(PA),即首剂后,医生必须获得药剂师的批准才能继续使用抗生素;(2)处方后审核和复查(PPR),即在治疗 72 小时后,药剂师将与医生沟通抗生素的使用是否合理。2 家医院进行了 6 个月的改良 PA,然后在 1 个月的洗脱期后进行了 6 个月的 PPR。另外 2 家医院则进行了相反的操作。

主要结果和措施:主要结局是干预措施的可行性,通过以下方面来确定:(1)在每家研究医院获得医院管理部门和委员会的批准;(2)药剂师培训的完成情况;(3)根据干预措施的数量、类型和结果来确定的启动和实施情况;(4)干预措施所需的时间。次要结局包括与匹配的历史时期相比的抗菌药物使用(治疗天数)和住院时间。

结果:共 2692 例患者(中位年龄 65 岁;四分位间距 53-76 岁)接受了研究干预;1413 例(52.5%)为女性,1323 例(49.1%)为白人,1047 例(38.9%)为非裔美国人。干预措施的审批时间中位数为 95 天(范围为 56-119 天);在此期间,严格的 PA 被认为是不可行的。相反,改良的 PA 干预措施在整个研究中都在使用。药剂师共进行了 1456 次改良 PA 干预(中位数为每家医院 350 次[范围为 129-628 次])和 1236 次 PPR 干预(中位数为每家医院 298 次[范围为 273-366 次])。在 PPR 期间,抗菌药物被认为不合理的比例是 PA 期间的两倍(41.0%[435/1060]与 20.4%[253/1243];P<0.001)。在改良 PA 干预期间,药剂师更常建议调整剂量(15.9%[232/1456]与 9.6%[119/1236];P<0.001),在 PPR 期间更常建议降级(29.1%[360/1236]与 13.0%[190/1456];P<0.001)。每个医院用于管理干预的时间中位数不同(每周管理时间中位数,范围为 5-19 小时)。与历史对照组相比,PPR 期间的总体抗生素使用量减少(每 1000 名患者-天的治疗天数中位数,925.2[109.8]与 965.3[109.4];平均差异,-40.1;95%置信区间,-71.7 至-8.6),但在改良 PA 期间没有减少(每 1000 名患者-天的治疗天数中位数,931.0[102.0]与 926.6[89.7];平均差异,4.4;95%置信区间,-55.8 至 64.7)。

结论和相关性:在研究医院,严格的 PA 是不可行的。相比之下,PPR 是一种在资源和专业知识有限的环境下进行抗菌药物管理的可行且有效的策略。

试验注册:ClinicalTrials.gov 标识符:NCT02212808。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7e1/6704742/6df3fe647561/jamanetwopen-2-e199369-g001.jpg

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