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CADTH Rapid Response Report: Summary with Critical Appraisal
Chantelle C. Lachance and Aleksandra Grobelna .
Ottawa (ON): Canadian Agency for Drugs and Technologies in Health ; 2019 May 14 . Copyright © 2019 Canadian Agency for Drugs and Technologies in Health.Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/
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Appraisal of Guidelines for Research & Evaluation
Centre for Reviews and Dissemination
Guideline Development Group
Grading for Recommendations Assessment, Development, and Evaluation
National Institute for Health and Care Excellence
Preferred Reporting Items for Systematic Reviews and Meta-Analyses
urinary tract infection
World Health Organization
Urinary bladder catheters are medical devices commonly used for urinary drainage or as a method of collecting urine for measurement. 1 – 3 For the purposes of urinary drainage, the choice of catheter type depends on the clinical indication and the expected duration of catheter use. 2
Urinary catheters can be external, urethral (i.e., indwelling, intermittent) or suprapubic. 2 External catheters are considered the least invasive since the device remains outside of the body in the form of a urinary pouch (available anyone) or a penile sheath catheter. 2 External catheters are an effective way to collect urine but are not indicated for management of urinary obstruction. 2 Urethral catheters are more invasive because the device is inserted transurethrally. Indwelling urethral catheters can be used for short-term bladder drainage or for the management of patients with chronic urinary retention. 2 Indwelling urethral catheters are the most common type of catheter used in the hospital setting. 2 Intermittent catheterization involves removing the catheter immediately after the bladder is decompressed and subsequent catheterizations on a scheduled basis. 2 This method can be used for short- and long-term management, depending on the condition being treated. 2 Some patients may not be candidates for intermittent catheterization due to discomfort, obesity, urinary obstruction or an upper-extremity impairment (for self-catheterization candidates). 2 Suprapubic catheters are the most invasive catheter type because they require a surgical procedure for the suprapubic catheter to be placed through the abdominal wall and into the bladder. 2 This mode allows for attempts at normal voiding without the requirement of re-catheterization and may prevent urethral trauma and stricture formation. 2
There are several clinical scenarios that are appropriately indicated for catheter use. For example, urinary catheters may be appropriately indicated for the management of urinary retention with or without bladder outlet obstruction, management of immobilized patients (e.g., pelvic fracture), hourly urine output measurement in critically ill patients, and improved patient comfort for end of life care. 2 , 4 Some evidence shows that catheters are used too frequently without meeting indications for appropriate use or may be used longer than required. 2 Findings from Canadian and international studies indicate that 21 to 50 percent of hospitalized patients receive an unwarranted urinary catheter. 2 , 5 – 9 In addition, one Ontario hospital reported that 18% of its hospitalized patients were catheterized, 69% of whom lacked an appropriate guideline-based reason. 10 The most common inappropriate indication is management of urinary incontinence via an indwelling catheter. 2 , 7 , 10 The misuse of catheters puts patients at risk, including an increased risk of urinary tract infections (UTIs). 2 Approximately 80% of health care-associated UTIs are related to the use of indwelling urinary catheters; 11 catheter-associated UTIs have been associated with increased morbidity, mortality, length of stay, and hospital costs. 11
The duration of catheter use is another key contributor to the type of catheter used and risks associated with their use. 2 Generally, short-term catheterization is considered less than a month and long-term catheterization is catheterization for one month or longer (i.e., 28 days or four weeks). 2 , 4 , 12 Long-term catheterization is considered when other methods are not effective or practical, 2 as long-term use can result in bacteriuria, UTI, blockage and bypassing (leakage around the catheter). 4 In particular, the two main indications for long-term indwelling catheters are urinary retention and urinary incontinence. 4
Providing evidence-based care on catheter use is important to improving patients’ outcomes and preventing urinary catheter-related complications. 2 , 13 – 15 Despite long-term indwelling catheter use being a common treatment plan to manage urinary retention and urinary incontinence, there is a lack of clarity on how to manage patients with long-term indwelling urinary catheters, including policies for replacing long-term urinary catheters. Thus, this report aims to summarize the evidence-based guidelines regarding the management of patients with long-term indwelling urinary catheters.
What are the evidence-based guidelines regarding the management of patients with long-term indwelling urinary catheters?
Four evidence-based guidelines on the management of patients with long-term indwelling urinary catheters were identified; three guidelines are commissioned by the National Institute for Health and Care Excellence and one guideline by the World Health Organization. Each guideline focuses on a different population, condition and/or aspect of a patient’s management plan. The following recommendations are provided: suprapubic catheters should be considered over long-term indwelling urethral catheters for women a with urinary incontinence; short duration bladder catheterization (i.e., seven to 10 days) is favoured over a longer duration of catheterization (i.e., more than 10 days) for post-operative patients who had repair of a simple obstetric urinary fistula; health care providers should consider removing or, if not possible, changing the catheter for patients who have a catheter-associated urinary tract infection if the catheter has been in place for more than seven days; do not routinely offer antibiotic prophylaxis for the prevention of catheter-associated urinary tract infections or when changing catheters for patients with long-term indwelling catheters. All guidelines use rigorous methodology to inform their recommendations, but the studies included to inform the recommendations are of varying quality, ranging from very low to moderate quality. It is also unclear how generalizable the recommendations are to the Canadian population. Therefore, caution is advised when interpreting these recommendations.
A limited literature search was conducted on key resources including PubMed, the Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. Methodological filters were applied to limit retrieval to health technology assessments, systematic reviews, meta-analyses and guidelines. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2014 and April 10, 2019.
One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.
Publications were excluded if they did not meet the selection criteria outlined in Table 1 or were published prior to 2014. Guidelines with unclear methodology were also excluded.
The included guidelines were assessed with the Appraisal of Guidelines for Research & Evaluation (AGREE II) instrument. 16 Summary scores were not calculated for the included studies; rather, a review of the strengths and limitations of each included guideline were described narratively.
A total of 441 citations were identified in the literature search. Following screening of titles and abstracts, 414 citations were excluded and 27 potentially relevant reports from the electronic search were retrieved for full-text review. Nine potentially relevant publications were retrieved through the grey literature search. Of these 36 potentially relevant articles, 32 were excluded for various reasons, and four guidelines met the eligibility criteria for inclusion in this report. Appendix 1 presents the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 17 flowchart of the study selection.
Additional references of potential interest are provided in Appendix 5.
Four evidence-based guidelines were included in this review. 18 – 21 Three guidelines were commissioned by the National Institute for Health and Care Excellence (NICE) and one guideline was commissioned by the World Health Organization (WHO).
The 2019 NICE guideline 18 is an update to a previous guideline (first published in 2006, first update in 2013) and covers the assessment and management of urinary incontinence and pelvic organ prolapse for women aged 18 and over. The 2018 NICE guideline 19 provides an antimicrobial prescribing strategy for catheter-associated UTI in children, young people, and adults to optimize antibiotic use and reduce antibiotic resistance. The 2017 NICE guideline 20 is an update to a previous guideline (first published in 2003, first update in 2012) that covers the prevention and control of health care-associated infections in children, young people, and adults in primary and community care settings. All three NICE guidelines 18 – 20 were developed in accordance with the methodology found in the NICE Guidelines Manual. 22 In brief, NICE guidelines conduct a systematic literature search (or a systematic literature search update if updating a guideline) to identify and synthesize relevant literature and the NICE Guideline Development Group (GDG) drafts and later finalizes recommendations. Recommendations are based on the trade-off between the benefits and harms of an intervention taking into consideration the quality of the underpinning evidence, among other factors (e.g., costs, current practices, recommendations made in other relevant guidelines, patient preferences, equality issues, stakeholder input). Regular checks are conducted to determine if an update is required.
The 2018 WHO guideline 21 aimed to consolidate guidance for the effective management of the indwelling catheter for patients after the surgical repair of simple obstetric urinary fistula. To produce the guideline, the research question and critical outcomes were identified and a systematic review was conducted and used to prepare evidence profiles for the priority question. Next, the WHO GDG made recommendations based on an assessment of the evidence (i.e., trade-off between benefits and harms, values and preferences of stakeholders, resource implications of the intervention, equity, acceptability and feasibility, quality of the underpinning evidence). A group of international experts, the GDG, then attended a technical consultation in 2017 to formulate and approve the recommendations. 21
The four guidelines used GRADE to assess quality of evidence and are externally peer-reviewed. 18 – 21
The three NICE guidelines 18 – 20 originate from the United Kingdom and the WHO guideline 21 is published from the WHO’s headquarters in Switzerland as international guidelines.
The intended users of the 2019 NICE guideline are health care professionals, service commissioners, women (≥ 18 years old) with urinary incontinence, pelvic organ prolapse, or complications associated with surgery for urinary incontinence or pelvic organ prolapse, their families, and carers. 18 The 2018 NICE guideline focuses on individuals with catheter-associated UTIs, and the intended users of the guideline include health professionals and individuals, of any age, with a catheter associated UTI, their families, and carers. 19 The 2018 WHO report focuses on individuals who require bladder catheterization after surgical repair of simple obstetric urinary fistula. 21 The intended user of the guideline includes health care professionals, particularly fistula surgeons and nurses providing postoperative care to patients after surgery for obstetric urinary fistula, national and local policy-makers, and staff of non-governmental and other organizations involved in fistula care services. 21 The 2017 NICE guideline focuses on patients who require long-term indwelling catheters. 20 The target users of the guideline are (i) commissioners and providers; (ii) health care professionals working in primary settings (general practices, dental clinics, health centres, polyclinics, and care delivered by the ambulance service) and community care settings (residential homes, nursing homes, the patient’s own home, schools and prisons); and (iii) children, young people and adults receiving health care for which standard infection-control precautions apply in primary and community care, and their families and carers. 20
Pertinent to this report, the three NICE guidelines evaluate long-term indwelling urinary catheters as the intervention. Specifically, the 2019 NICE guideline 18 explores long-term (duration not provided) indwelling urethral catheterization for those with urinary incontinence or pelvic organ prolapse. The 2018 NICE guideline 19 focuses on administering antibiotic prophylaxis and removing or changing long-term indwelling urethral catheters (after seven days) for people with a catheter-associated UTI. The 2017 NICE guideline 20 focuses on administering antibiotic prophylaxis and exploring the catheter type for patients with long-term indwelling urinary catheters (duration not provided) for the prevention and control of health care-associated infections. 20 The 2018 WHO guideline 21 reviews the duration of bladder catheterization (i.e., short duration, seven to 10 days; long duration, more than 10 days) after surgical repair of simple obstetric urinary fistula.
The outcomes for the guidelines target clinical effectiveness, including symptomatic bacteriuria, 19 symptomatic UTI, 18 , 20 post-repair UTI, 21 recurrent UTIs, 19 bypassing, 18 encrustations, 20 blockages, 20 urethral complications, 18 antibiotic resistance, 19 risk of fistula repair breakdown before and after hospital discharge, 21 urinary incontinence during and after hospital discharge, 21 extended hospital stay, 21 quality of life, 20 patient comfort 20 maternal satisfaction with care, 21 urinary retention after catheter removal 21 , and mean number of days the catheter remains in situ (mean dwell time). 20 Two guidelines also consider resource use (e.g., costs of care). 20 , 21
Additional details regarding the characteristics of included publications are provided in Appendix 2.
The four evidence-based guidelines 18 – 21 were assessed using the AGREE II tool. 16 All included guidelines are considered high quality.
All guidelines 18 – 21 fulfilled the criteria for Domain 1 (scope and purpose) and Domain 2 (stakeholder involvement) of the AGREE II checklist: the overall objectives, health questions, and populations to whom the guidelines apply are specifically described; GDGs included individuals from all relevant professional groups; the guideline developers sought the views and preferences of the target population (patients, public, etc.); the target users of the guidelines are clearly defined. These features may increase the reliability of the recommendations as they demonstrate sound methodology and make these publications less prone to biases.
All guidelines 18 – 21 fulfilled most or all of the criteria for Domain 3 (rigour of development) of the AGREE II checklist: systematic methods are used to search for evidence; the criteria for selecting the evidence, the strengths and limitations of the body of evidence, and the methods for formulating the recommendations are described; the health benefits, side effects, and risks are considered in the formulation of the recommendations; the guideline was externally reviewed by experts prior to its publication; and a procedure for updating the guideline is provided. The 2018 WHO guideline 21 also provided an explicit link between the recommendations and the supporting evidence (i.e., all criteria fulfilled). The NICE guidelines, 18 – 20 however, require some interpretation and a review of the NICE manual 22 to make the link between the recommendation and the supporting evidence. NICE guidelines provide information about the body of literature used to inform the guideline, including its quality (level of detail varies between guidelines); however, the formal recommendations use a specific syntax that the reader must be aware of in order to link the quality of evidence with the recommendation. For example, NICE uses “offer” to reflect a strong recommendation and “consider” reflecting a recommendation where the evidence of a benefit is less certain.
All guidelines 18 – 21 fulfilled the criteria for Domain 4 (clarity of presentation) of the AGREE II checklist: the recommendations are specific and unambiguous; the different options for management of the condition or health issue are clearly presented; and key recommendations are easily identifiable.
All guidelines 18 – 21 fulfilled most or all of the criteria for Domain 5 (applicability) of the AGREE II checklist: guidelines describe facilitators and barriers to its application; the guidelines provide advice and/or tools on how the recommendations can be put into practice; and the potential resource implications of applying the recommendations have been considered. The 2018 WHO guideline 21 also provides details on monitoring/auditing criteria (i.e., all criteria fulfilled). The 2017 NICE guideline 20 provides an example of a published audit project under the shared learning section of the resources page for this guideline, but it is unclear if this would be considered monitoring and/or auditing criteria for users of the guideline. Monitoring and/or auditing criteria are not described for the 2018 or 2019 NICE guidelines. 18 , 19
The final domain of the AGREE II checklist (Domain 6, editorial independence) identified limitations in three of the four guidelines. The 2018 WHO guideline 21 declares its competing interests and funding sources, and acknowledges that the funding body did not influence the content of the guideline. In contrast, the funding body of the 2019 NICE guideline 18 was involved in the guideline development process. Though the NICE manual indicates guidelines are developed by independent and unbiased committees of experts, having a funding body involved in the guideline development process represents a potential bias; it is unclear these competing interests are adequately addressed. Similarly, the 2017 NICE guideline 20 states the funder of the guideline also supports the development of this guideline, introducing potential bias. This guideline, however, did declare competing interests of the GDG members and no competing interests are identified. Finally, no details on funding or competing interests are provided for the 2018 NICE guideline. 19
Additional details regarding the strengths and limitations of included publications are provided in Appendix 3.
Since each guideline aims to address different health questions, the findings are summarized based on the health topic/patient population they intend to serve.
The 2019 NICE guideline 18 focuses on the management of urinary incontinence and pelvic organ prolapse in women aged 18 and over. This guideline indicates knowledge users should consider the use of indwelling suprapubic catheters as an alternative to long-term urethral catheters; this is based on evidence suggesting indwelling suprapubic catheters provide lower rates of symptomatic UTI, bypassing, and urethral complications. The guideline also provides a list of indications for when the use of long-term indwelling urethral catheters are appropriate for those with urinary incontinence, including chronic urinary retention in those who are unable to manage intermittent self-catheterization; skin wounds, pressure ulcers or irritations that are being contaminated by urine; distress or disruption caused by bed and clothing changes; and where an individual expresses a preference for this form of management. The quality of evidence to inform these specific guidelines is unclear. 18
The 2018 WHO guideline 21 recommends a short duration bladder catheterization (i.e., seven to 10 days) for those in the postoperative period after the surgical repair of a simple obstetric urinary fistula, as an alternative to longer duration of catheterization (i.e., more than 10 days). This recommendation is based on low to moderate quality of evidence. Of the nine outcomes considered, evidence from the academic literature did not find a clinical difference between shorter and longer duration catheterization for seven outcomes (risk of fistula repair breakdown before hospital discharge, risk of fistula repair breakdown after hospital discharge, urinary incontinence after hospital discharge, extended hospital stay, post-repair UTI, urinary incontinence during hospital stay, urinary retention after catheter removal), and no evidence was found for two outcomes of interest (patient satisfaction with care, cost of care). Thus, the recommendation to have a shorter duration of catheterization was derived by the GDG based on other benefits, including improvement in patients’ comfort, potential reduction in the risk of infections associated with the catheterization, and decrease in patients’ needs for health services. 21
Two guidelines, the 2017 20 and 2018 19 NICE guidelines, focus on health care associated infections.
The 2018 NICE guideline 19 considers antibiotic prophylaxis and catheter type for patients with long-term indwelling urinary catheters for the prevention and control of health care-associated infections. The guideline recommends the consideration of removing or, if not possible, changing the catheter as soon as possible for patients who have a catheter-associated UTI if the catheter has been in place for more than seven days. For prevention of catheter-associated UTIs, the guideline does not recommend routinely offering antibiotic prophylaxis to prevent catheter-associated UTIs in patients with a long-term indwelling catheter. 19 Evidence to support these recommendations are of varying quality (range: very low to moderate). 19
Likewise, the 2017 NICE guideline 20 does not recommend routinely offering antibiotic prophylaxis when changing catheters in patients with a long-term indwelling urinary catheter. Moreover, the guideline suggests considering antibiotic prophylaxis for patients who have a history of symptomatic UTI after catheter change or experience trauma during catheterization. These recommendations are based on GDG consensus. Appendix 4 presents a table of the main recommendations and strength of evidence.
The primary limitations to the body of evidence regarding long-term indwelling catheters are the lack of overlap between the included guidelines, the varying levels of evidence to inform guidelines, the lack of data on particular outcomes of interest, and the paucity of guidelines produced for the Canadian context.
The lack of overlap between guidelines is a strength and a limitation. Because the included guidelines cover different populations and/or clinical conditions, it is expected that there is little overlap between them. Since all of the included guidelines are evidence-based and conducted a systematic literature search to inform the guidelines, each guideline used several studies to inform the recommendations. This is a strength. With the exception of two guidelines not recommending prophylaxis antibiotics for patients with indwelling catheters, there is little overlap between outcomes explored and management strategies used. This makes it difficult to determine the similarities and differences between each guideline’s recommendations (i.e., it is unclear if the independent GDG committees would have had similar conclusions as other GDGs from another included guideline). Moreover, one guideline describes the frequency of changing a long-term indwelling catheter with focus on patients with an active UTI. No evidence is provided on the frequency of changing long-term indwelling catheters for patients without a UTI. No guidelines provided strategies that are specific to the prevention or resolution of catheter occlusion. Future research in Canada may benefit from investigating the frequency of changing long-term indwelling catheters for patients without UTIs and prevention or management strategies for catheter occlusion.
The quality of the evidence to inform the guidelines is variable (range: from very low to high). In addition, some outcomes of interest for certain GDGs resulted in no relevant data; for example, no data was found for patient satisfaction with care and cost of care for those in the postoperative period after the surgical repair of a simple obstetric urinary fistula. 19 , 21
All of the included guidelines are produced outside of Canada. Though the 2018 WHO guideline is meant for an international audience, 21 it is still unclear how generalizable the recommendations are to the Canadian setting.
These limitations warrant the use of caution when interpreting the findings of this report.
Four evidence-based guidelines regarding the management of patients with long-term indwelling urinary catheters use were identified in the search. Recommendations are derived from studies with a variable quality of evidence. Each guideline focuses on a different population, condition, and/or aspect of a patient’s management plan. Together, the guidelines provide the following recommendations: (i) use indwelling suprapubic catheters as an alternative to long-term indwelling catheters for those are experiencing urinary incontinence and pelvic organ prolapse; 18 (ii) use indwelling catheters for a shorter duration (i.e., seven to 10 days) instead of a longer duration (i.e., more than 10 day) for post-operative patients who had a repair of a simple obstetric urinary fistula; (iii) consider removing or changing the indwelling catheter for patients who have a catheter-associated UTI if it has been in place for over seven days; and (iv) do not routinely offer antibiotic prophylaxis to patients with a long-term indwelling catheter in an attempt to prevent a catheter-associated UTI or when changing the catheter. Evidence to inform the included guidelines was found to range from very low to moderate quality.
To reduce uncertainty in the management of long-term indwelling catheters, evidence of high methodological quality describing specific outcomes is needed, including frequency of changing indwelling catheters for patients without UTIs and prevention or management strategies for catheter occlusion. Caution is advised in interpreting the information presented in this report due to the absence overlap between the included guidelines, the varying levels of evidence to inform guidelines, the lack of data on particular outcomes of interest, and the paucity of guidelines produced for the Canadian context.
Recognizing there is a spectrum of gender identities, the word women is used throughout this report in reference to this guideline, which is the language used in the original guidelines. The intention of this decision is to prevent misinterpretation of the guideline’s findings. It is recognized, however, that the word women may not be entirely representative of the gender spectrum that the recommendations are relevant to.
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