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1
2
3 REVIEW
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5 Silver alloy vs. uncoated urinary catheters: a systematic review of the
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7
literature
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9
Michelle Beattie and Julie Taylor
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12 Aims and objectives. This systematic review aimed at determining whether there was enough evidence in the literature to
13 conclude that silver-alloy urinary catheters indeed reduce catheter-associated urinary tract infections in comparison with the use
14 of silicone or latex urinary catheters in adult inpatients.
15 Background. Previous systematic reviews into the effectiveness of silver-coated urinary catheters have offered limited oppor-
16 tunity to transfer their findings into practice. These studies have been on American products only, of generally poor quality, or
17 indeed several years since their completion (Cochrane Database Systematic Reviews, 1, 2004, CD004013; Johnson 2005).
18 Design. A systematic review of the literature was deemed the most appropriate research method to apply as there had already
19 been several studies (Archives of International Medicine, 160, 2000, 2670; American Journal of Infection Control, 30, 2002,
20 221; The Journal of Urology, 173, 2005, 846) relating to the subject in question, although there were some queries regarding
21 their methodological rigour.
22 Methods. Randomised control trials, systematic reviews and meta-analysis were identified by searching relevant databases.
23 Relevant papers were judged against predefined inclusion and exclusion criteria. Ten per cent of papers were assessed by a second
24 reviewer. Following the application of a numerical filtering tool, six papers were rejected and eleven papers were retained.
25 Results. Of the 11 papers retained, there were eight studies, because of some studies publishing more than one paper. The
26 integrated results did present a consistent pattern favourable towards the efficacy of silver-alloy urinary catheters to reduce
27 catheter-associated urinary tract infection.
28 Conclusion. The collective evidence divulged an emerging pattern favouring the efficacy of silver-alloy urinary catheters to reduce
29 catheter-associated urinary tract infection. Owing to the poor quality of some individual studies included in other systematic
30 reviews and the inability to carry out meta-analysis because of significant heterogeneity, definitive conclusions cannot be drawn
31 from the study.
32 Relevance to clinical practice. Given the significant prevalence of catheter-associated urinary tract infection, early indications of
33 improved infection rate outcomes using silver-alloy urinary catheters should not be dismissed.
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35 Key words: catheter-associated urinary tract infection, nurses, nursing, silver, systematic review, urinary catheter
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37 Accepted for publication: 19 August 2010
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million annually in Scotland (NHS Quality Improvement
41 Introduction
Scotland 2005). Because of the current high profile of patient
42 Health care-associated infections (HCAI) are estimated to safety and significant media coverage of ‘dirty’ hospitals,
43 effect approximately 33,000 people per year and cost £186 HCAI is high on both the public and Government agenda.
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45
Authors: Michelle Beattie, BSc, MSc, RN, Lecturer, Department of Correspondence: Michelle Beattie, Lecturer, Department of Nursing
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Nursing and Midwifery, University of Stirling, Highland Campus, and Midwifery, University of Stirling, Highland Campus, Centre for
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Centre for Health Science, Inverness; Julie Taylor, BSc, MSc, PhD, Health Science, Old Perth Rd, Inverness IV2 3JH, Scotland, UK.
48 RN, RNT, Professor, Head of Strategy and Development (Physical Telephone: 01463 255622.
49 Abuse in High Risk Families), NSPCC, Centre for Learning, Child E-mail: michelle.beattie@stir.ac.uk
50 Protection Unit, Edinburgh, Scotland, UK
1 There is consistent evidence that catheter-associated urinary from the market (Brosnahan et al. 2004). The use of silver- 3
2 tract infections (CAUTI) account for a significant number of coated catheters has been sporadic in clinical practice,
3 HCAIs (NHS Quality Improvement Scotland 2004, Pratt probably because of the debatable evidence associated with
4 et al. 2007, Madeo et al. 2009). These infections are often their effectiveness as well as significant cost implications.
5 associated with an increased period of hospitalisation and Silver-coated catheters are significantly more expensive at
6 morbidity, resulting in poor outcomes for patients and their approximately £5Æ50 per catheter in comparison with Teflon
7 families, as well as significant economic cost to the National catheters at £0Æ86.
8 Health Service (NHS). The purpose of this systematic review
9 was to establish whether or not the use of silver-alloy urinary
Aims and methods
10 catheters can reduce the incidence of CAUTI.
11 Silver has been used for medicinal purposes since Greek The aim of this systematic review was to examine current
12 and Roman times. By the early 1900s, silver was used for its studies, as well as build on existing reviews, to determine
13 wide-spectrum antimicrobial properties until the discovery of whether or not there is evidence to conclude that silver-alloy
14 penicillin in 1928. Silver-impregnated dressings have been urinary catheters reduce CAUTI in comparison with the use
15 used over the decades to reduce infection in burn wounds. of standard silicone or latex urinary catheters in short-term
16 The use of silver-coated urinary catheters was first introduced hospitalised adult patients. Only adult patients requiring
17 in the United States approximately 10 years ago and approx- short-term (< 2 weeks) catheter use were included because
18 imately five years ago in the UK (Dawson, personal commu- of the prevalence of bacteraemia in all long-term catheterised
19 2 nication). There have been some claims that silver-coated patients. This systematic review only considered urethral
20 urinary catheters reduce biofilm formation and or reduce catheterisation as supra-pubic catheterisation has different
21 colonisation by releasing silver ions into the urinary tract risk factors (Robinson 2005). A flow diagram was created to
22 (Centre for Evidence-Based Purchasing 2006). Urinary cath- plan the review (Fig. 1).
23 eters can be coated in silver alloy or silver oxide. Studies Although there is no definitive hierarchy of evidence, there
24 involving silver oxide catheters, however, have not been is a general consensus that systematic reviews and meta-
25 found to reduce CAUTI in comparison with other catheter analysis of primary research are the highest ranked methods.
26 types (Saint et al. 1998) and have subsequently been removed Randomised controlled trials (RCT) follow closely behind
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28
LOW RESOLUTION FIG
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49 Figure 1 Flowchart of planned systematic 41
50 review process.
1 systematic reviews and are acknowledged as the ‘gold All UK catheter suppliers and known experts were
2 standard’ for testing interventions (Sheffield University contacted to identify potential research papers. The only
3 2008). When methods lower down on the hierarchy are commercial company producing silver-alloy catheters was
4 used, there is an increased risk of bias, although utilising Bard, of which seven papers were received. The University
5 these methods are often wholly appropriate depending on the Library database of postgraduate student’s thesis was also
6 research question being asked. A systematic review was searched, and no papers were found on the subject area. In
7 selected not because of its prestige, but because it was best total, the search yielded 148 papers. All duplicate papers
8 suited to the intervention question. The aim is to use the were then removed by hand – resulting in 97 papers.
9 methodology highest on the hierarchy to suit the research Inclusion and exclusion criteria were predetermined to
10 question. As the method provides a succinct overview of minimise bias and to target relevant papers. It is essential that
11 several studies, it is particularly useful for busy practitioners once the criteria are identified, they are adhered to reduce the
12 who strive to use evidence-based practice, but would not have risk of introducing bias (CRD 2009). An inclusion selection
13 the time to access all the individual studies. form was devised to standardise the process (Fig. 2). When
14 The initial question was formulated using the PICO the inclusion and exclusion criteria were applied to all
15 acronym for Patient, Intervention, Comparison and Outcome abstracts, 14 were accepted, three were undecided and 80
16 (Lang 2004). The question was refined to ‘In short-term were rejected (Table 2). The three abstracts undecided
17 hospitalised adult patients, do silver-alloy urinary catheters (Karchmer et al. 1997, 1998, Maki et al. 1998) required full
18 reduce CAUTI in comparison with the use of standard papers to be retrieved as there was insufficient data to apply
19 silicone or latex urinary catheters?’ the inclusion and exclusion criteria. Following retrieval of the
20 The following databases were scrutinised to obtain rele- remaining three papers, they were accepted. In total, 17 were
21 vant studies – Medical Literature Analysis and Retrieval accepted and 80 were rejected.
22 System Online, Cumulative Index to Nursing and Allied As applying the criteria requires a judgement to be made by
23 Health Literature, British Nursing Index, Excerpta Medica the reviewer, it is recommended that two reviewers indepen-
24 Database, Database of Abstracts of Reviews of Effectiveness, dently review papers to reduce bias (CRD 2009). Ten per cent
25 Cochrane Database of Systematic Reviews, Cochrane Central of all papers (97/10 = 9Æ7, rounded to 10) were reviewed
26 Register of Control Trials, Meta Register Clinical Trial and independently by a second reviewer (JT) using the predeter-
27 the FADE Library of grey literature. Full details and results of mined inclusion and exclusion criteria. The ten papers were
28 the search strategy are detailed in Table 1. randomly selected using the ‘random’ function within Excel.
29
30
Table 1 Search strategy 30
31
32 Search Final
33 Ovid database function Key word searched Restrictions results
34 MEDLINE (R) – 1950 – March Advanced Silver AND urinary catheter$ (92) RCT and from year 1990 (15) 15
35 week 4 2008
36 CINHAL – 1982 – February Advanced Silver AND urinary catheter$ (32) From year 1990 no limits for RCT 31
37 week 5 2008
BNI & Archive – 1985 – February 2008 Advanced Silver AND urinary catheter$ (7) From year 1990 no limits for RCT 7
38
EMBASE – 1980 – week 14 2008 Advanced Silver AND urinary catheter$ (52) From year 1990 no limits for RCT 50
39 DARE – 14 March 2008 Basic Silver AND urinary catheter$ (11) No limits for RCT restriction/year 11
40 CDSR – first quarter 2008 Advanced Silver AND urinary catheter$ (4) No restrictions applied 4 31
41 CENTRAL – first quarter 2008 Advanced Silver AND urinary catheter$ (18) No restrictions applied 18
42 MRCT – 14 March 2008 Basic Silver AND urinary catheter! (3) No restrictions applied 3
FADE – 20 March 2008 Basic Silver AND urinary catheter$ (69) From year 1990 & research 2
43
BARD Via post Silver-coated urinary catheters No restrictions applied 7
44
Dundee University Library database Postgraduate students thesis searched No restrictions applied 0
45 Total 148
46
BNI, British Nursing Index; CDSR, Cochrane Database of Systematic Reviews; CENTRAL, Cochrane Central Register of Control Trials;
47
CINHAL, Cumulative Index to Nursing and Allied Health Literature; DARE, Database of Abstracts of Reviews of Effectiveness; EMBASE,
48 Excerpta Medica Database; MEDLINE, Medical Literature Analysis and Retrieval System Online; MRCT, Meta register of Controlled Trials;
49 RCT, randomised controlled trials.
50 Duplicates were removed by hand searching abstracts. There were 51 duplicates removed (148 51 = 97).
35 Programme (CASP 2006a) were used. The tools produced by Brosnahan & Kent (2004)* Liedberg and Lundeberg (1990)
36 this unit were selected as they have been developed from Brosnahan, Jull and Tracy Liedberg et al. (1990)
37 guides produced by an expert panel at McMaster University (2008)*
Rosier (2004)* Liedberg and Lundeberg (1993) 37
38 and have been rigorously piloted (Oxman et al. 1993). The
Niel-Weise et al. (2002) Thibon et al. (2000)
39 Systematic Review Tool (CASP 2006b) was used to structure Johnson et al. (2006) Verleyen et al. (1999a/b)
40 the critique on studies that have used this methodology. Saint et al. (1998)
41 Likewise, the RCT tool (CASP 2006c) was used to critique
*All denote the same study and will be referred to in subsequent text
42 studies that used RCT or meta-analysis.
as the updated version of Brosnahan, Jull and Tracy (2008).
43
Two papers on the same study and will be referred to in subsequent
44 text as the original version Liedberg and Lundeberg (1990).
Table 4 Numerical scoring system to detect bias
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46 0–1 Low-risk bias Scoring A
2–3 Moderate-risk bias Scoring B
Results
47
48 4 High-risk bias Scoring C The eight studies retained were scrutinised using the appro-
49 All papers scoring C’s were rejected and those scoring A or B were priate CASP (2006b,c) critical analysis tools by MB. The
50 retained. analysis highlighted that there was significant heterogeneity
1 overall odds ratio result. The odds ratio for bacteriuria was patients to each arm of the trial threatened the studies’
2 0Æ59 (95% CI, 0Æ42–0Æ84) indicating a significant benefit internal validity and therefore results.
3 for patients with silver-coated urinary catheters. They con- Despite the fact that an estimation of sample size is
4 clude that silver-alloy urinary catheters may be worth the essential in the planning of an RCT, only one study (Thibon
5 extra cost as CAUTI is a common cause of nosocomial et al. 2000) actually documented a power calculation (Moher
6 infection. et al. 1995). Thibon et al. (2000) based their estimation on a 9
7 UTI incidence of 37%, estimating that 90 subjects per group 10
8 would be needed to demonstrate a 50% reduction in
Niel-Weise et al. (2002)
9 incidence with the coated catheter, with a risk of 5% and a
10 Niel-Weise et al. (2002) evaluated the literature to determine power of 90%. However, the overall incidence rate was
11 the effectiveness of silver-coated vs. uncoated catheters for 11Æ1% and therefore larger numbers would be needed than
12 the prevention of CAUTI. Only the results pertaining to they originally predicted.
13 silver-alloy catheters were considered for this systematic All RCTs used Chi square and Fisher’s exact tests to analyse
14 review. They calculated the relative risk with 96% CI for their results. Chi square is used to determine whether observed
15 each study as well as the relative risk of subgroups (i.e. frequencies are different to those that would occur by chance.
16 gender) where information was available. They did not carry In these studies, the formula was used to calculate whether the
17 out meta-analysis to combine results as only one of their rate of bacteriuria was significantly different depending on
18 included studies achieved a high-quality score. The one high- whether a silver-alloy or uncoated urinary catheter was used.
19 quality study did not show efficacy of silver-coated catheters. The Chi square needs to have enough data to be greater than a
20 They concluded that there was insufficient evidence to two by two table. When samples are small, which was
21 recommend the use of silver-coated urinary catheters. apparent in some of the RCTs, the researchers appropriately
22 used Fisher’s exact test. As the name suggests, the process is
23 exact; therefore, it can be used regardless of sample numbers
Synthesis of results
24 or characteristics. All RCTs used Kaplan–Meier plots to
25 Meta-analysis of the results of this systematic review would visually demonstrate bacteriuria over time. Data are presented
26 be inappropriate because of significant heterogeneity between on an x and y axis, where x represented number of days and y
27 included studies. Heterogeneity was apparent in study design, axis number of patients, which enabled easy interpretation.
28 population, types of uncoated catheters used as comparisons, Kaplan–Meier is used to estimate the probability of an event
29 urine sampling methodologies and definitions of outcome over time, but where competing risks are present, the results
30 measures. There was, however, consistency among studies for are not interpretable (Harris & Taylor 2003). Competing
31 statistical methods used – risk ratios calculated in the risks such as gender, catheter types, co-morbidities etc are
32 systematic reviews and Chi square, Fischer’s exact test and apparent in the population studied.
33 Kaplan–Meier estimator used in all RCTs. All systematic reviews reported relative risk ratios. Relative
34 Of the systematic reviews which concluded that silver-alloy risk is a ratio of the probability of the event occurring in the
35 urinary catheters did reduce the incidence of bacteriuria exposed group vs. a non-exposed group. Appropriately, the
36 (Saint et al. 1998 and Brosnahan et al. 2008), there were studies used this measure to compare the risk of bacteriuria
37 questions over their validity. Both systematic reviews numer- between patients receiving silver-alloy catheters and those
38 ically combined the results of each study despite acknowl- receiving uncoated catheters. All reviews calculated confi-
39 edgement that some were of poor quality and there was dence intervals using a fixed effect model. Fixed effect models
40 significant heterogeneity between studies. Saint et al.’s (1998) take account of variation between each study (heterogeneity).
41 combined odds ratio results showed 0Æ59 (95% CI 0Æ42–0Æ84) The model can only control variation which is fixed, i.e.
42 indicating a significant benefit for silver-coated catheters. factors that do not change over time, such as gender. This
43 Brosnahan et al. (2008) was of good quality, although they would not take account of other evolving variables such as
44 suggested that their results should be interpreted with caution co-morbidities, although these would be unlikely to change
45 because of the general poor quality of some included studies. over the length of time of the study, i.e. 14 days.
46 Of the RCTs that did show statistical significance, there In summary, the studies were either unable to demonstrate
47 were questions over their validity. Both studies by the statistical significance or drew conclusions with caution
48 Liedberg group had small sample numbers, and both studies because of significant heterogeneity or poor-quality studies.
49 were carried out in the same institution. Verleyen et al. No study was able to clearly demonstrate statistically and
50 (1999a/b) lack of concealment and their methods of allocating with validity that in short-term hospitalised adult patients,
1 silver-alloy urinary catheters reduce CAUTI in comparison they did not occur. For example, if a study did not stipulate
2 with the use of standard silicone or latex urinary catheters. that their participants were blinded to the intervention, then
3 Collectively, the results of this systematic review show there it was assumed that this did not take place and the study
4 is a consistent pattern emerging supporting the effectiveness would therefore score poorly for bias. This may have resulted
5 of silver-alloy urinary catheters over uncoated catheters to in studies being harshly criticised because of the lack of
6 reduce CAUTI. information they had published rather than the quality of
7 their research. Ideally, where insufficient information led to
8 an assumption of omission, this should have been clarified by
Discussion
9 contacting original authors. The limitation of time did not
10 Although this review was unable to draw any definitive allow further probing to attain further information, however.
11 conclusions, the integrated results did present an emerging This lack of information when publishing research has been
12 pattern favourable towards the efficacy of silver-alloy urinary acknowledged and led to the creation of the Consolidated
13 catheters. The purpose of research in health care is to evolve Standards for Reporting Trials statement, which aims to
14 patient care by transferring findings into practice (Davies improve the transparency of reporting RCTs (Moher et al.
15 2002). Before integrating evidence into practice, however, the 2001). Although this would not improve the reporting of
16 quality of this systematic review needs to be assessed and SRs, these standards have been adapted for use in reporting
17 any limitations of the study acknowledged. other research (Altman et al. 1991). When considering the 12
18 The CASP tool for reviews (CASP 2006a) was used as a quality of this systematic review, however, utilising a strin-
19 11 framework to assess the quality of this SR as it has been gent tool would only increase confidence in the overall results.
20 rigorously piloted. Applying scrutiny to this review, as was Sample sizes also need to be large enough from which to
21 applied to the retained studies, helped to ensure equity and a generalise. Only one study (Thibon et al. 2000) determined a
22 transparent process. The details of the literature search have power calculation for their study. To determine a power
23 been well documented that would enable another researcher calculation, researchers need to know the frequency of an
24 to repeat the process and allocate the same papers. Unfor- event – in this case, the frequency of CAUTI. Most probably,
25 tunately, the same could not be said for some of the the frequency of CAUTI is not known because of the
26 systematic reviews included in this study. Limitations of this significant variation in defining and therefore reporting
27 review are mainly related to the moderate evidence and CAUTI. No studies measured symptomatic CAUTI, however,
28 significant heterogeneity of the studies included. most likely because of the subjectivity involved in interpreting
29 If the review were to be replicated, the author would ensure symptoms. Many of the symptoms in symptomatic CAUTI
30 that the quality assessment included ethical considerations as would rely on the patients’ description of their symptoms, for
31 these issues are fundamental in health care research. One example, painful urination. Pain is a subjective experience
32 Japanese study (Takeuchi et al. 1993) was excluded from the and differs considerably between individuals, which causes
33 study because of translation costs and their results may have considerable complexity when attempting to measure.
34 positively influenced the outcome of this review, had the All studies reported asymptomatic CAUTI (bacteria in the
35 study been valid and reliable. Although probably more a urine without other symptoms) as their outcome measure.
36 learning point than a weakness of the study; where there is The definitions of bacteriuria varied amongst their trials from
37 more than one study, it is advisable to refer to the earliest 105–108 CFU/l, or involved a combination of variables.
38 version (Dwan et al. 2008). The author did not know this Although more complex to measure, further accuracy of
39 until the review was nearly complete and the latest version of catheter effectiveness would be achieved by measuring
40 Brosnahan et al. (2008) study was referred to rather than symptomatic CAUTI as bacteriuria increases for every day
41 their original paper in 2004. There were, however, no major an individual has a catheter in place (Pratt et al. 2007). Only
42 differences between studies. The main difference between the patients with symptomatic bacteriuria would be treated,
43 2004–2008 version was an updated literature review; there- whereas those with asymptomatic bacteriuria would not be
44 fore, using the latest version would not have changed the treated because of the risk of antibiotic resistance. As patients
45 outcome of this review. with asymptomatic bacteriuria would not normally be
46 The numerical quality filtering tool used to critique the treated, they are not usually counted as a CAUTI, which
47 studies was adapted from the Cochrane Collaboration (2006) makes it difficult, if not impossible, to determine the fre-
48 as it was intentionally designed for RCTs and not SRs. The quency. To determine power calculations for future research,
49 tool rigorously assessed the studies for bias; however, the tool universal definitions are required for both symptomatic and
50 made the assumption that if details were not published, then asymptomatic bacteriuria. When a RCT is started without a
1
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17 Wilcox M (2007) EPIC 2: National Challenges – The Strategy for Research dence of hospital-acquired urinary tract
18 Evidence-Based Guidelines for Pre- and Development in Nursing and infections. Journal of Hospital Infection
19 venting Healthcare Associated Infec- Midwifery in Scotland. Scottish Gov- 45, 117–24.
tions in NHS Hospitals in England. 27 ernment, ????????. Verleyen P, De Ridder D, Van Poppel H &
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Journal of Hospital Infections 655, Scottish Government (2006) Modernising Baert L(1999a/b) Clinical application
21 S1–S64. Nursing Careers: Setting the Direction. of the Bardex IC Foley catheter. Euro-
22 Robinson ??? (2005) Clinical skills: how to The Scottish Government, Edinburgh. pean Urology 36, 240–6. (Both studies
23 remove and change a suprapubic cath- 28 August, ISBN 07559-5213-8. published in one paper).
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