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首页> 外文期刊>Health technology assessment: HTA >Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial- and antiseptic-impregnated urethral catheters (the CATHETER trial)
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Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial- and antiseptic-impregnated urethral catheters (the CATHETER trial)

机译：在需要短期插管的住院成年人中，用于减少症状性尿路感染的导尿管类型：多中心随机对照试验和抗菌和防腐剂浸渍导尿管的经济评估（CATHETER试验）

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Background: Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital and incurs significant costs for health-care providers such as the UK NHS. Many preventative strategies and measures have been introduced to minimise CAUTI risk, including the use of antimicrobial catheters. However, there is considerable uncertainty regarding their usefulness in terms of reducing symptomatic CAUTI, and whether or not they are cost-effective. Objectives: Do antimicrobial catheters reduce the rate of symptomatic urinary tract infection (UTI) during short-term hospital use and is their use cost-effective for the UK NHS? Design: A pragmatic multicentre UK randomised controlled trial comparing three catheters as they would be used in the UK NHS: antimicrobial-impregnated (nitrofurazone) and antiseptic-coated (silver alloy) catheters with the standard polytetrafluoroethylene (PTFE)-coated catheters. Economic evaluation used a decision model populated with data from the trial. Sensitivity analysis was used to explore uncertainty. Setting: Relevant clinical departments in 24 NHS hospitals throughout the UK. Participants: Adults requiring temporary urethral catheterisation for a period of between 1 and 14 days as part of their care, predominantly as a result of elective surgery. Interventions: Eligible participants were randomised 1:1:1 to one of three types of urethral catheter in order to make the following pragmatic comparisons: nitrofurazone-impregnated silicone catheter compared with standard PTFE-coated latex catheter; and silver alloy-coated hydrogel latex catheter compared with standard PTFE-coated latex catheter. Main outcome measures: The primary outcome for clinical effectiveness was the incidence of UTI at any time up to 6 weeks post randomisation. This was defined as any symptom reported during catheterisation, up to 3 days or 1 or 2 weeks post catheter removal or 6 weeks post randomisation combined with a prescription of antibiotics, at any of these times, for presumed symptomatic UTI. The primary economic outcome was incremental cost per quality-adjusted life-year (QALY). Health-care costs were estimated from NHS sources with QALYs calculated from participant completion of the European Quality of Life-5 Dimensions (EQ-5D). Results: Outcome analyses encompassed 6394 (90%) of 7102 participants randomised. The rate of symptomatic UTI within 6 weeks of randomisation was 10.6% in the nitrofurazone group (n = 2153; -2.1 % absolute risk difference), 12.5% in the silver alloy group (n = 2097; -0.1% absolute risk difference) and 12.6% in the PTFE group (n = 2144).
机译：背景：与导管相关的尿路感染（CAUTI）是可预防的对医院患者造成伤害的主要原因，并给英国NHS等医疗服务提供者带来了高昂的费用。为了减少CAUTI的风险，已引入了许多预防策略和措施，包括使用抗菌导管。但是，就减少症状性CAUTI的有效性以及它们是否具有成本效益而言，存在很大的不确定性。目的：抗菌导管是否可以减少短期住院期间症状性尿路感染（UTI）的发生率，并且使用英国NHS是否具有成本效益？设计：一项实用的英国多中心随机对照试验，比较了英国NHS中将使用的三种导管：抗菌浸渍（硝基呋喃酮）和防腐剂涂覆（银合金）的导管以及标准的聚四氟乙烯（PTFE）涂覆的导管。经济评估使用了一个决策模型，该决策模型填充了试验数据。敏感性分析用于探索不确定性。地点：英国24家NHS医院的相关临床部门。参加者：主要由于择期手术而需要临时尿道插管持续1到14天的成人作为其护理的一部分。干预措施：将符合条件的参与者以1：1：1的比例随机分配到三种类型的尿道导管中的一种，以进行以下实用比较：氮呋喃酮浸渍的硅胶导管与标准PTFE涂层的乳胶导管比较;与银合金涂层的水凝胶乳胶导管相比，标准的PTFE涂层的乳胶导管。主要结局指标：临床有效性的主要结局是随机分配后长达6周的任何时间的UTI发生率。这被定义为在导管插入过程中，拔除导管后最多3天或1或2周或随机分组后6周内报告的任何症状，在任何这些时间结合抗生素处方，用于有症状的UTI。主要的经济成果是每质量调整生命年（QALY）的增量成本。卫生保健费用是从NHS来源估算的，而QALYs是根据参与者完成《欧洲生活质量5维度》（EQ-5D）得出的。结果：结果分析涵盖了随机分配的7102名参与者中的6394名（90％）。在呋喃酮组中，随机分配的6周内症状性尿路感染的发生率为10.6％（n = 2153;绝对风险差异为-2.1％）;在银合金组中为12.5％（n = 2097;绝对风险差异为-0.1％）， PTFE组为12.6％（n = 2144）。

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