Cooper Fergus P M, Alexander Cameron Edwin, Sinha Sanjay, Omar Muhammad Imran
Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK, AB25 2ZD.
Cochrane Database Syst Rev. 2016 Jul 26;7(7):CD011115. doi: 10.1002/14651858.CD011115.pub2.
Long-term indwelling catheters are used commonly in people with lower urinary tract problems in home, hospital and specialised health-care settings. There are many potential complications and adverse effects associated with long-term catheter use. The effect of health-care policies related to the replacement of long-term urinary catheters on patient outcomes is unclear.
To determine the effectiveness of different policies for replacing long-term indwelling urinary catheters in adults.
We searched the Cochrane Incontinence Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 19 May 2016), and the reference lists of relevant articles.
All randomised controlled trials investigating policies for replacing long-term indwelling urinary catheters in adults were included.
At least two review authors independently performed data extraction and assessed risk of bias of all the included trials. Quality of evidence was assessed by adopting the GRADE approach. Any discrepancies were resolved by discussion between the review authors or an independent arbitrator. We contacted the authors of included trials to seek clarification where required.
Three trials met the inclusion criteria, with a total of 107 participants in three different health-care settings: A USA veterans administration nursing home; a geriatric centre in Israel; and a community nursing service in Hong Kong. Data were available for three of the pre-stated comparisons. Priefer and colleagues evaluated different time intervals between catheter replacement (n = 17); Firestein and colleagues evaluated the use of antibiotic prophylaxis at the time of replacement (n = 70); and Cheung and colleagues compared two different types of cleaning solutions (n = 20).All the included trials were small and under-powered. The reporting of the trials was inadequate and as a result, risk of bias assessment was judged to be unclear for the majority of the domains in two out of the three trials. There was insufficient evidence to indicate that (i) there was a lower incidence of symptomatic UTI in people whose catheter was changed both monthly and when clinically indicated (risk ratio (RR) 0.35, 95% confidence interval (CI) 0.13 to 0.95; very low quality evidence) compared to only when clinically indicated, (ii) there was not enough evidence to assess the effect of antibiotic prophylaxis on reducing: positive urine cultures at 7 days (RR 0.91, 95% CI 0.79 to 1.04); infection (RR 1.41, 95% CI 0.55 to 3.65); or death (RR 2.12, 95% CI 0.20 to 22.30; very low quality evidence), (iii) there was no statistically significant difference in the incidence of asymptomatic bacteruria at 7 days (RR 0.80, 95% CI 0.42 to 1.52) between people receiving water or chlorhexidine solution for periurethral cleansing at the time of catheter replacement. However, none of the 16 participants developed a symptomatic catheter-associated urinary tract infection (CAUTI) at day 14.The following outcomes were considered critical for decision-making and were also selected for the 'Summary of findings' table: (i) participant satisfaction, (ii) condition-specific quality of life, (iii) urinary tract trauma, and (iv) formal economic analysis. However, none of the trials reported these outcomes.None of the trials compared the following comparisons: (i) replacing catheter versus other policy e.g. washouts, (ii) replacing in the home environment versus clinical environment, (iii) clean versus aseptic technique for replacing catheter, (iv) lubricant A versus lubricant B or no lubricant, and (v) catheter user versus carer versus health professional performing the catheter replacement procedure.
AUTHORS' CONCLUSIONS: There is currently insufficient evidence to assess the value of different policies for replacing long-term urinary catheters on patient outcomes. In particular, there are a number of policies for which there are currently no trial data; and a number of important outcomes which have not been assessed, including patient satisfaction, quality of life, urinary tract trauma, and economic outcomes. There is an immediate need for rigorous, adequately powered randomised controlled trials which assess important clinical outcomes and abide by the principles and recommendations of the CONSORT statement.
长期留置导尿管常用于家庭、医院及专业医疗环境中患有下尿路问题的人群。长期使用导尿管会引发许多潜在并发症和不良反应。与长期导尿管更换相关的医疗政策对患者预后的影响尚不清楚。
确定不同政策对成人长期留置导尿管更换的有效性。
我们检索了Cochrane尿失禁专业试验注册库,其中包含从Cochrane对照试验中央注册库(CENTRAL)、MEDLINE、MEDLINE在研、MEDLINE印刷版之前的电子版、CINAHL、ClinicalTrials.gov、世界卫生组织国际临床试验平台检索到的试验,以及对期刊和会议论文集的手工检索(检索日期为2016年5月19日),并检索了相关文章的参考文献列表。
纳入所有调查成人长期留置导尿管更换政策的随机对照试验。
至少两名综述作者独立进行数据提取,并评估所有纳入试验的偏倚风险。采用GRADE方法评估证据质量。如有分歧,由综述作者或独立仲裁者讨论解决。如有需要,我们会联系纳入试验的作者以寻求澄清。
三项试验符合纳入标准,共107名参与者来自三种不同的医疗环境:一家美国退伍军人管理局疗养院;以色列的一家老年中心;以及香港的一项社区护理服务。可获得预先设定的三项比较中的三项数据。普里弗及其同事评估了导尿管更换的不同时间间隔(n = 17);菲尔斯坦及其同事评估了更换时使用抗生素预防的情况(n = 70);张及其同事比较了两种不同类型的清洁溶液(n = 20)。所有纳入试验规模较小且效能不足。试验报告不充分,因此,在三项试验中的两项试验中,大多数领域的偏倚风险评估结果不明。没有足够的证据表明:(i)与仅在临床指征时更换导尿管相比,每月及临床指征时更换导尿管的人群中,有症状的尿路感染发生率较低(风险比(RR)0.35,95%置信区间(CI)0.13至0.95;极低质量证据);(ii)没有足够的证据评估抗生素预防对降低以下方面的效果:7天时尿培养阳性(RR 0.91,95%CI 0.79至1.04);感染(RR 1.41,95%CI 0.55至3.65);或死亡(RR 2.12,95%CI 0.20至22.30;极低质量证据);(iii)更换导尿管时接受水或洗必泰溶液进行尿道周围清洁的人群,7天时无症状菌尿的发生率无统计学显著差异(RR 0.80,95%CI 0.42至1.52)。然而,16名参与者中在第14天均未发生有症状的导尿管相关尿路感染(CAUTI)。以下结局被认为对决策至关重要,也被选入“结果总结”表中:(i)参与者满意度;(ii)特定疾病的生活质量;(iii)尿路创伤;(iv)正式的经济分析。然而,没有一项试验报告了这些结局。没有一项试验比较以下内容:(i)更换导尿管与其他政策(如冲洗);(ii)在家庭环境与临床环境中更换;(iii)更换导尿管的清洁与无菌技术;(iv)润滑剂A与润滑剂B或不使用润滑剂;(v)导尿管使用者与护理者与进行导尿管更换操作的卫生专业人员。
目前尚无足够证据评估不同的长期导尿管更换政策对患者预后的价值。特别是,目前有许多政策没有试验数据;还有许多重要结局未被评估,包括患者满意度、生活质量、尿路创伤和经济结局。迫切需要进行严格的、有足够效能的随机对照试验,以评估重要的临床结局,并遵循CONSORT声明的原则和建议。