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用于慢性尿潴留的间歇性导尿管:一项卫生技术评估

Intermittent Catheters for Chronic Urinary Retention: A Health Technology Assessment.

出版信息

Ont Health Technol Assess Ser. 2019 Feb 19;19(1):1-153. eCollection 2019.

Abstract

BACKGROUND

People with chronic urinary retention typically require intermittent catheterization. This review evaluates the effectiveness, safety, patient preference, cost-effectiveness, and budget impact of different types of intermittent catheter (IC). Specifically, we compared prelubricated catheters (hydrophilic, gel reservoir) and noncoated catheters, as well as their single use versus reuse (multiple use).

METHODS

We performed a systematic literature search and included randomized controlled trials, cohort, and case-control studies that examined any type of single-use versus multiple-use IC, hydrophilic single-use versus noncoated single-use, or gel reservoir single-use versus noncoated single-use. The outcomes of interest were symptomatic urinary tract infection (UTI), hematuria, other serious adverse events, and patient satisfaction. The quality of the body of evidence was examined according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also completed an economic evaluation, using the perspective of the Ontario Ministry of Health and Long-Term Care, to determine the cost-effectiveness of various intermittent catheters used in Ontario. We determined the budget impact of fully and partially funding various intermittent catheters for outpatients with chronic urinary retention. To understand patient experiences with intermittent catheterization, we interviewed 34 adults and parents of children affected by chronic urinary retention.

RESULTS

We found 14 randomized controlled trials that met the inclusion criteria. When comparing any type of single-use or multiple-use IC, we found no difference in UTI (RR = 0.98, 95% CI 0.70-1.39), hematuria, or serious adverse events, and inconclusive evidence on patient satisfaction.Our meta-analysis of studies on people living in the community showed that hydrophilic ICs may result in fewer UTIs than single-use noncoated ICs, but given the nature of the studies, we were uncertain about this conclusion.The nature of the available evidence also did not allow us to make definitive conclusions regarding whether one type of catheter was likely to result in less hematuria, fewer serious adverse events, or greater patient satisfaction.Our economic evaluation found that owing to small differences in quality-adjusted life-years and moderate to large incremental cost differences, the lowest-cost ICs-noncoated multiple-use (using one catheter per week or one catheter per day)-have the highest probability of being cost-effective. In a subpopulation of those clinically advised not to reuse ICs, single-use noncoated ICs have the highest probability of being cost-effective. As current funding is limited in the outpatient setting, publicly funding noncoated multiple-use catheters (one per day) would result in a total additional cost of $93 million over the first 5 years. People who use ICs reported that the high ongoing cost of purchasing catheters was a financial burden. Almost all said they would prefer not to reuse catheters sold as "single use" but could not afford to do so.

CONCLUSIONS

Given the overall low quality of evidence in available studies, we are uncertain whether any specific type of IC (coated or noncoated, single- or multiple-use) significantly reduces symptomatic UTI, hematuria, or other serious adverse clinical events, or whether a specific type improves patient satisfaction. Therefore, the lowest-cost IC is likely the most cost-effective.

摘要

背景

慢性尿潴留患者通常需要间歇性导尿。本综述评估了不同类型间歇性导尿管(IC)的有效性、安全性、患者偏好、成本效益及预算影响。具体而言,我们比较了预润滑导尿管(亲水型、凝胶储库型)与非涂层导尿管,以及它们的一次性使用与重复使用情况。

方法

我们进行了系统的文献检索,纳入了随机对照试验、队列研究和病例对照研究,这些研究探讨了任何类型的一次性与多次使用的IC、亲水型一次性与非涂层一次性,或凝胶储库型一次性与非涂层一次性。感兴趣的结局包括有症状的尿路感染(UTI)、血尿、其他严重不良事件和患者满意度。根据推荐分级、评估、制定与评价(GRADE)工作组标准检查证据质量。我们还从安大略省卫生和长期护理部的角度进行了经济评估,以确定安大略省使用的各种间歇性导尿管的成本效益。我们确定了为慢性尿潴留门诊患者全额或部分资助各种间歇性导尿管的预算影响。为了解患者在间歇性导尿方面的经历,我们采访了34名受慢性尿潴留影响的成年人及儿童家长。

结果

我们找到了14项符合纳入标准的随机对照试验。在比较任何类型的一次性或多次使用的IC时,我们发现UTI(RR = 0.98,95% CI 0.70 - 1.39)、血尿或严重不良事件无差异,且关于患者满意度的证据尚无定论。我们对社区居民研究的荟萃分析表明,亲水型ICs可能比一次性非涂层ICs导致的UTIs更少,但鉴于研究的性质,我们对这一结论并不确定。现有证据的性质也不允许我们就一种类型的导尿管是否可能导致更少的血尿、更少的严重不良事件或更高的患者满意度得出明确结论。我们的经济评估发现,由于质量调整生命年差异较小,成本增量差异为中度至较大,成本最低的ICs——非涂层多次使用(每周使用一根导尿管或每天使用一根导尿管)——具有最高的成本效益可能性。在临床建议不要重复使用ICs的亚组中,一次性非涂层ICs具有最高的成本效益可能性。由于门诊环境中目前资金有限,公开资助非涂层多次使用导尿管(每天一根)在头5年将导致额外总成本9300万美元。使用ICs的人报告说,购买导尿管的持续高额成本是一项经济负担。几乎所有人都说他们宁愿不重复使用标为“一次性使用”的导尿管,但无力承担。

结论

鉴于现有研究中证据的总体质量较低,我们不确定任何特定类型的IC(涂层或非涂层、一次性或多次使用)是否能显著降低有症状的UTI、血尿或其他严重不良临床事件,或是否某种特定类型能提高患者满意度。因此,成本最低的IC可能是最具成本效益的。

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