Stalenhoef Janneke E, van der Starre Willize E, Vollaard Albert M, Steyerberg Ewout W, Delfos Nathalie M, Leyten Eliane M S, Koster Ted, Ablij Hans C, Van't Wout Jan W, van Dissel Jaap T, van Nieuwkoop Cees
Department of Infectious Diseases, Leiden University Medical Center, C5-P, PO Box 9600, 2300 RC, Leiden, the Netherlands.
Department of Public Health, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.
BMC Infect Dis. 2017 Jun 6;17(1):400. doi: 10.1186/s12879-017-2509-3.
There is a lack of severity assessment tools to identify adults presenting with febrile urinary tract infection (FUTI) at risk for complicated outcome and guide admission policy. We aimed to validate the Prediction Rule for Admission policy in Complicated urinary Tract InfeCtion LEiden (PRACTICE), a modified form of the pneumonia severity index, and to subsequentially assess its use in clinical practice.
A prospective observational multicenter study for model validation (2004-2009), followed by a multicenter controlled clinical trial with stepped wedge cluster-randomization for impact assessment (2010-2014), with a follow up of 3 months. Paricipants were 1157 consecutive patients with a presumptive diagnosis of acute febrile UTI (787 in validation cohort and 370 in the randomized trial), enrolled at emergency departments of 7 hospitals and 35 primary care centers in the Netherlands. The clinical prediction rule contained 12 predictors of complicated course. In the randomized trial the PRACTICE included guidance on hospitalization for high risk (>100 points) and home discharge for low risk patients (<75 points), in the control period the standard policy regarding hospital admission was applied. Main outcomes were effectiveness of the clinical prediction rule, as measured by primary hospital admission rate, and its safety, as measured by the rate of low-risk patients who needed to be hospitalized for FUTI after initial home-based treatment, and 30-day mortality.
A total of 370 patients were included in the randomized trial, 237 in the control period and 133 in the intervention period. Use of PRACTICE significantly reduced the primary hospitalization rate (from 219/237, 92%, in the control group to 96/133, 72%, in the intervention group, p < 0.01). The secondary hospital admission rate after initial outpatient treatment was 6% in control patients and 27% in intervention patients (1/17 and 10/37; p < 0.001).
Although the proposed PRACTICE prediction rule is associated with a lower number of hospital admissions of patients presenting to the ED with presumptive febrile urinary tract infection, futher improvement is necessary to reduce the occurrence of secondary hospital admissions.
NTR4480 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4480 , registered retrospectively 25 mrt 2014 (during enrollment of subjects).
目前缺乏用于识别患有发热性尿路感染(FUTI)且有复杂结局风险的成人患者的严重程度评估工具,也缺乏指导住院政策的工具。我们旨在验证莱顿复杂尿路感染住院政策预测规则(PRACTICE),这是肺炎严重指数的一种改良形式,并随后评估其在临床实践中的应用。
一项用于模型验证的前瞻性观察性多中心研究(2004 - 2009年),随后是一项采用阶梯楔形整群随机化进行影响评估的多中心对照临床试验(2010 - 2014年),随访3个月。参与者为1157例连续的疑似急性发热性尿路感染患者(验证队列787例,随机试验370例),在荷兰7家医院和35个初级保健中心的急诊科入组。临床预测规则包含12个复杂病程预测因素。在随机试验中,PRACTICE为高危患者(>100分)提供住院指导,为低危患者(<75分)提供居家出院指导,在对照期采用关于住院的标准政策。主要结局为临床预测规则的有效性(通过主要住院率衡量)及其安全性(通过初始居家治疗后因FUTI需要住院的低危患者比例以及30天死亡率衡量)。
随机试验共纳入370例患者,对照期237例,干预期133例。使用PRACTICE显著降低了主要住院率(从对照组的(219/237),92%,降至干预组的(96/133),7%,(p < 0.01))。初始门诊治疗后的二次住院率在对照患者中为6%,在干预患者中为27%((1/17)和(10/37);(p < 0.001))。
尽管所提出的PRACTICE预测规则与急诊科疑似发热性尿路感染患者的住院人数减少相关,但仍需进一步改进以减少二次住院的发生。
NTR4480 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4480 ,于2014年3月25日追溯注册(在受试者入组期间)。