Background
Patients are at risk for catheter harm when they are admitted to a hospital, surgical center, or long-term care facility, or evaluated in the outpatient setting. In the acute-care setting, 15%–25% of patients are exposed to a urinary catheter during their hospitalization. Appropriate catheter use improves patient outcomes by releasing an underlying obstruction or providing accurate intake and output information for managing critically ill patients. Exposure to urinary catheters places patients at risk for both infectious and noninfectious complications, but the main outcome focus so far has been catheter-associated urinary tract infection (CAUTI). Historically, CAUTIs account for more than one-third of healthcare-associated infections (HAIs) reported by acute-care hospitals.Reference Magill, Edwards and Bamberg 1 , Reference Klevens, Edwards and Richards 2 With the recognition of colonization in catheterized patients and surveillance definition changes, the proportion of CAUTIs relative to other HAIs has decreased.Reference Magill, Edwards and Bamberg 1 , Reference Magill, O’Leary and Janelle 3
HAI Metrics
The metrics used for measuring HAIs are important because these infections are publicly reported. They impact Center for Medicaid Services (CMS) reimbursements and influence quality improvement efforts. A variety of metrics are used to track US healthcare-system performance related to CAUTIs. Since 2010, discrepancies in reductions have been reported based on the metric used. The differences between outcomes reported by the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Disease Control and Prevention (CDC) can be explained by differences in data acquisition and type of denominator.Reference Calderon, Kavanagh and Rice 4
The CDC’s National Healthcare Safety Network (NHSN) provides standardized surveillance definitions for all HAIs. The NHSN surveillance definition for CAUTI has been refined multiple times over the last 2 decades.Reference Advani, Lee, Schmitz and Camins 5 , Reference Press and Metlay 6 These revisions to the NHSN CAUTI definition have important implications for the perceived effectiveness of CAUTI prevention efforts and for comparisons between hospitals. Moreover, inclusion of the NHSN CAUTI in the CMS hospital-acquired condition reduction program has led to ubiquitous reliance on this performance metric. 7 The standardized infection ratio (SIR), which is the ratio of observed to predicted NHSN CAUTI events, is the nationally used metric to gauge improvements in CAUTI prevention. 8
NHSN CAUTI as a surrogate of catheter harm
The NHSN CAUTI metric has often been used as a surrogate for patient harm related to the urinary catheter. In an attempt to reach a more accurate definition for symptomatic CAUTI, the NHSN surveillance definition was updated in January 2015 to exclude funguria and lower urine-culture colony counts. 9 These definitional changes resulted in marked reductions in reported NHSN CAUTI events.Reference Advani, Lee, Schmitz and Camins 5 , Reference Fakih, Groves, Bufalino, Sturm and Hendrich 10 , Reference Bardossy, Jayaprakash and Alangaden 11 However, these reductions in surveillance CAUTI events do not reflect a decrease in catheter-associated bacteriuria (CA bacteriuria) or events treated inappropriately with antimicrobials.Reference Al-Qas Hanna, Sambirska, Iyer, Szpunar and Fakih 12 Overall, the CAUTI metric may not adequately reflect infectious harm, and it is rarely associated with bacteremia.Reference Tambyah and Maki 13 , Reference Kizilbash, Petersen, Chen, Naik and Trautner 14
Due to the reliance on the presence of a positive urine culture and fever as integral elements of the surveillance definition, NHSN CAUTI events are more susceptible to changes in testing or ordering practices and the prevalence of fever.Reference Al-Qas Hanna, Sambirska, Iyer, Szpunar and Fakih 12 Such practices may eclipse process improvement initiatives, centered on proper device need and care.Reference Mullin, Kovacs and Fatica 15 , Reference Bardossy, Williams and Jones 16 Additionally, the national focus has been on preventing NHSN CAUTI events rather than catheter-related harm. Noninfectious catheter complications, such as urethral injury, pain, or inadvertent catheter removal, have received limited attention.Reference Bardossy, Williams and Jones 16 , Reference Fakih, Gould and Trautner 17 The catheter also limits patient mobility and increases the risk of falling because it acts as a “1-point restraint.”Reference Saint, Lipsky and Goold 18 In a recent study of patient-reported outcomes after urinary catheter insertions, noninfectious complications were 5 times more likely than infectious complications. A high percentage of patients also reported restrictions of social activities and activities of daily living.Reference Saint, Trautner and Fowler 19
Recognition of bacteriuria and its impact on the CAUTI definition
Historically, many attempts have been made to refine the CAUTI definition. A principal barrier in this endeavor has been the difficulty in diagnosing a CAUTI solely based on laboratory findings. In contrast to blood, in which pathogen detection equates infection, healthy urinary tracts host a complex microbial community. Recognition of this bladder microbiome offers a new perspective.Reference Finucane 20 The prevalence of asymptomatic bacteriuria varies from 1% to 8% in nonpregnant women, from 3% to 20% in elderly persons living in the community, and from 15% to 50% in elderly residing in long-term care facilities. This limits the utility of a urinalysis or urine culture in the absence of urinary tract infection (UTI) symptoms.Reference Nicolle, Bradley and Colgan 21 Consequently, the isolation of organisms from urine cultures in the absence of symptoms has a poor positive predictive value for UTI.
The risk of colonization in catheterized patients ranges between 3% and 10% per day, reaching 100% in patients with long-term indwelling catheters.Reference Garibaldi, Mooney, Epstein and Britt 22 , Reference Warren, Tenney, Hoopes, Muncie and Anthony 23 Patients with indwelling urinary catheters can experience symptoms such as dysuria, urinary frequency, or suprapubic discomfort secondary to the urinary catheter itself, which makes diagnosing a CAUTI difficult. Due to the high incidence of CA bacteriuria and associated nonspecific symptoms when catheterized, patients may be mistakenly labeled as having CAUTI.Reference Hooton, Bradley and Cardenas 24 Hence, the Infectious Diseases Society of America (IDSA) guidelines recommend ruling out alternative causes of a fever before attributing it to CA bacteriuria.Reference Hooton, Bradley and Cardenas 24 Clinically, a CAUTI is often a diagnosis of exclusion unless there is evidence of genitourinary obstruction or pyelonephritis.Reference Livorsi and Perencevich 25 Contradictory to the above clinical definitions, the NHSN CAUTI definition attributes fever to a positive urine culture irrespective of presence of other sources of infection.
CAUTI prevention strategies and their unintended consequences
Various strategies consistent with and beyond the standard guidelines have been implemented for prevention of CAUTIs. The main focus has been on promoting appropriate catheter utilization and care, developing reflex urine culture protocols, implementing stewardship of culturing, and using alternatives to the indwelling urinary catheter. Although many interventions have been successful, some have met mixed results. We discuss the most commonly implemented strategies for CAUTI prevention and some of their unintended consequences in the following sections.
Promoting appropriate device utilization and care
To date, most interventions focused on CAUTI prevention have concentrated on judicious urinary catheter use. Interventions to reduce unnecessary catheter use through reminders and removal orders have decreased overall catheter complications.Reference Meddings, Rogers, Krein, Fakih, Olmsted and Saint 26 Reducing device utilization is the most important strategy to prevent catheter harm, whether infectious or noninfectious. Early statewide CAUTI prevention work in Michigan reduced catheter use by providing alternatives to indwelling urinary catheters, avoiding unnecessary catheter use, and early removal.Reference Saint, Greene, Kowalski, Watson, Hofer and Krein 27 – Reference Fakih, Watson and Greene 29 Consequently, the AHRQ supported “On the CUSP—Stop CAUTI,” a national effort to prevent CAUTI focusing on optimizing catheter use and care.Reference Fakih, George, Edson, Goeschel and Saint 30 , Reference Saint, Greene and Krein 31 Other strategies that have been advocated include proper insertion and maintenance of catheters with adherence to aseptic technique, hand hygiene, and maintenance of a closed urinary collecting system.Reference Magill, Edwards and Bamberg 1 , Reference Hooton, Bradley and Cardenas 24
Although decreasing catheter use represents one of the most important interventions, it may not lower NHSN CAUTI rates or the SIR in all settings. Some interventions that decrease catheter days (denominator) may select for a higher risk group of catheterized patients, thus resulting in higher rate of CAUTIs (numerator) or SIR in some settings (despite a reduction in the absolute number of events for the overall population).Reference Fakih, Greene and Kennedy 32 In a study by Wright et al,Reference Wright, Kharasch, Beaumont, Peterson and Robicsek 33 decreasing the device utilization by 22% increased the CAUTI rate by 6%. They showed a reduction in their CAUTI rate using patient days as the denominator instead of catheter days. Hence, the current metric that calculates CAUTI rates using catheter days as a denominator may place hospitals that successfully reduce their catheter use at a disadvantage. This metric may fail to incentivize programs actively engaged in reducing device usage.
Urinalysis with reflex to cultures
Many hospitals are modifying urine culture ordering practices with “urinalysis with reflex to culture” or “reflex urine culture” protocols to avoid unnecessary use.Reference Epstein, Edwards and Halpin 34 This restricts urine culture testing to when urinalysis is found to be positive for 1 or more parameters: leukocyte esterase, nitrite, white blood cells (WBCs), or bacteria. The reflex protocol has been well validated in the outpatient setting as an initial screening test in patients with UTI symptoms. The utility of this protocol in other settings is controversial. One of the challenges is the dearth of evidence on the urinalysis parameters that best predict infection. A normal urinalysis has a high negative predictive value for UTIs,Reference Stovall, Haenal and Jenkins 35 whereas positive urinalysis parameters like pyuria and bacteriuria have a low positive predictive value, especially for CAUTIs.Reference Humphries and Dien Bard 36 – Reference Trautner 39
Reflex protocols focus on laboratory findings rather than trying to elicit informed decisions before placing the orders.Reference Tambyah and Maki 37 A positive test for nitrite can indicate presence of gram-negative bacteriuria, but it cannot definitively diagnose a UTI in the absence of symptoms. Given the high rate of bladder and catheter colonization, reflex protocols are not preferred in catheterized patients unless they are targeted to patients with symptoms like flank pain or UTI symptoms after recent catheter removal. Future studies evaluating the impact of varying thresholds of pyuria in reflex protocols may help decrease unnecessary urine cultures rather than diagnose UTIs.Reference Humphries and Dien Bard 36 , Reference Fakih and Khatib 40
Other challenges with reflex protocols include variability in specimen collection techniques. Evidence suggests that urine samples with >5–8 squamous epithelial cells may have poor yield. Current protocols do not adjust for urine contamination, quality of specimen, or transport time. The performance of a urinalysis differs by laboratory and depends on the testing standards and capacity.Reference Humphries and Dien Bard 36
Stewardship of culturing
More recent interventions to reduce CAUTI have focused on “stewardship of culturing” or reducing inappropriate urine cultures in catheterized patients. This goal is driven by ongoing recognition that patients with an indwelling urinary catheter have a high incidence of colonization. The American College of Critical Care Medicine (ACCCM) and IDSA advocate that positive urine cultures in catheterized patients do not require treatment in most cases. In their joint guidance for workup of fever in a catheterized critically ill patient, they recommend urine cultures only in (1) kidney transplant recipients, (2) neutropenic patients, (3) patients with recent genitourinary surgery, and (4) patients with evidence of genitourinary obstruction.Reference O’Grady, Barie and Bartlett 41 Mullin et alReference Mullin, Kovacs and Fatica 15 showed >30% reduction in their CAUTI rates by decreasing inappropriate urine cultures in their intensive care units by 48% without a significant change in catheter utilization.Reference Fakih and Khatib 40 This reduction in CAUTI rates may not reflect a decrease in true UTIs; rather, it highlights the sensitivity of the NHSN definition to rate of culturing.
Hence, we recommend a 2-pronged testing approach in catheterized patients.Reference Fakih and Khatib 40 The first step is to develop an optimized process to decide when it is appropriate to obtain urinalyses and urine cultures in these patients. Examples include removal of urinalysis and culture from nonurologic preoperative screening, discouraging indiscriminate “pan-culturing” in response to fever, and excluding catheterized patients from reflex urine culture protocols. The second step is centered on physician engagement and education around the significance of bacteriuria and pyuria, and the risk of urine testing in the absence of signs and symptoms.Reference Mullin, Kovacs and Fatica 15 , Reference Fakih and Khatib 40 , Reference Keller, Feldman, Smith, Pahwa, Cosgrove and Chida 42 Urine cultures obtained as a part of pan-culturing can falsely elevate NHSN CAUTI events, even in the presence of an alternate source of infection due to high incidence of catheter colonization. Advani et alReference Advani, Smith and Fisher 43 developed a urine culture algorithm for catheterized patients that focuses on directed evaluation of signs and symptoms before obtaining urine cultures (with exclusions for signs of pyelonephritis, obstruction or sepsis, and pregnant or neutropenic patients). Thoughtful culturing through algorithm-directed evaluation of fever based on signs and symptoms led to a 27% reduction in unnecessary urine culture orders and >30% reduction in CAUTIs at their medical center.Reference Advani, Smith and Fisher 43
Under ideal circumstances, stewardship of culturing has downstream benefits on antibiotics use, decreasing antimicrobial resistance and/or resource utilization. However, caution is advised; diagnostic stewardship that limits urine cultures indiscriminately may drive providers to administer broad-spectrum antibiotics to treat for clinical suspicion alone, without the opportunity to de-escalate or discontinue antibiotic therapy in the absence of urine-culture results.Reference Morgan, Malani and Diekema 44 Stewardship of culturing can be a clinically successful strategy in the setting of ongoing education and open communication and feedback.Reference Mullin, Kovacs and Fatica 15 , Reference Fakih and Khatib 40 It should be integrated into daily activities of clinicians or hardwired into the electronic medical record using a computerized decision-support routine in daily work.Reference Keller, Feldman, Smith, Pahwa, Cosgrove and Chida 42 However, such testing approaches will be effective only if they are accepted and perceived as effective by healthcare workers. For long-term success, continued collaboration between different stakeholders and disciplines, with a supportive internal and external environment, is needed.Reference Krein, Damschroder, Kowalski, Forman, Hofer and Saint 45
Alternatives to indwelling catheters
External collection devices (ECDs) have been advocated as alternatives to indwelling urinary catheters.Reference Hooton, Bradley and Cardenas 24 , Reference Gould, Umscheid, Agarwal, Kuntz and Pegues 46 ECDs have been traditionally used for men, but they have also been developed for women. In the past, female ECDs had considerable challenges with containing urinary output, avoiding damage to the pubic skin or vaginal mucosa, and remaining in place. Currently, we do not have enough data about ECD indications, efficacy studies, or cost analyses of CAUTI prevention bundles that incorporate ECDs.Reference Gray, Skinner and Kaler 47
Despite their better tolerability and design, the newer female ECDs are associated with significant cost and nursing burden from frequent replacement, which is required every 8–12 hours. Both male and female patients using ECDs are still susceptible to UTIs, even if these devices eliminate NHSN CAUTI events. Furthermore, these ECDs may be associated with adverse events such as an increased risk of skin breakdown, and they may not be suitable for patients undergoing high-volume diuresis. Using these ECDs will result in a decrease in catheter days (denominator), with a possibility of increasing CAUTI rates or SIR in some settings.
Aligning outcomes with interventions and seeking more inclusive metrics
The NHSN SIR (or device SIR) is the nationally used metric to compare an institution’s performance to the national benchmark from a baseline period. However, this metric may not adequately capture the impact of CAUTI prevention efforts in all scenarios. The SIR does not adjust for local factors related to overuse of catheters (thus potentially lower risk per catheter day) or strong reductions in catheter use (ie, unit-specific interventions) where selected patients with indwelling catheters may move to a higher risk category. 8 Additionally, our surveillance methods involve manual chart review and multidimensional definitions, which are prone to error and bias. Hence, these metrics risk shifting the emphasis from processes focused on reducing catheter harm toward reducing surveillance CAUTIs.Reference Bardossy, Williams and Jones 16 Appropriate performance metrics should capture clinically significant catheter harm and provide meaningful information to facilities to improve outcomes. We propose 3 key metrics to align outcomes with interventions: the standardized utilization ratio (SUR), population SIR, and CA bacteriuria.
Device utilization and Standardized Utilization Ratio (SUR)
The risk of device harm is ongoing as long as the catheter is in use. Beyond focusing on reducing unnecessary catheter insertions and catheter days, utilization is a process and outcome measure that reflects the risk of infectious and noninfectious sequelae of catheter use.Reference Abrantes-Figueiredo, Ross and Banach 48 Device utilization is an overall objective metric that captures potential catheter harm, but it does not measure appropriateness of use or duration of catheter use per patient. For example, the risk of CAUTI may be different in a unit with a single indwelling catheter for 10 days compared to a unit with 5 catheters for 2 days each, despite both units reporting the same device days (1 catheter ×10 days = 5 catheters × 2 days = 10 catheter days).Reference Fakih, Gould and Trautner 17 The recently introduced SUR helps identify whether a unit or a hospital uses more catheters than its comparators. The SUR is a ratio of observed to predicted device days and is compared to a national benchmark. 49 The SUR adjusts for hospital- and unit-level factors and may be used as a surrogate for potential catheter harm.
Population Standardized Infection Ratio (SIR)
The SIR or “device SIR” is a ratio of observed to predicted NHSN CAUTI events and is based on the number of actual observed catheter days for a specific unit. Both device SIR and SUR provide valuable information about a patient’s risk related to a urinary catheter. However, a metric that represents population risk can combine both elements. This is calculated as the ratio of observed to predicted NHSN-CAUTI events based on the predicted device days (compared to device SIR which is based on actual device days). This metric, “population SIR,” accounts for the risk of device exposure and infection to all patients. Importantly, both device SIR and population SIR use the NHSN CAUTI definition. However, population SIR will entice teams to also focus on noninfectious complications because it rewards hospitals that focus on device utilization. Population SIR can also better account for both, changes in device utilization and CAUTI risk over time.Reference Fakih, Greene and Kennedy 32
Catheter-Associated Bacteriuria
Catheter-associated bacteriuria is common in patients with indwelling catheters and, in its vast majority, is asymptomatic. Inappropriate antimicrobial exposure in patients with asymptomatic CA bacteriuria increases the risk for resistance, adverse drug events, and Clostridioides difficile colitis.Reference Hooton, Bradley and Cardenas 24 , Reference Trautner 39 , Reference Daneman, Bronskill and Gruneir 50 Because the identification of CA bacteriuria is a key driver to inappropriate antibiotic use, including it as a performance metric may reduce catheter harm and support antimicrobial stewardship efforts.Reference Naik, Skelton, Amspoker, Glasgow and Trautner 51 , Reference Spivak, Burk and Zhang 52 Capturing CA bacteriuria can be fully automated from electronic medical records, and it can be risk adjusted similar to the standardized antibiotic administration ratio (SAAR).Reference van Santen, Edwards and Webb 53 Tracking specific patients with CA bacteriuria that receive antimicrobial therapy may incorporate both diagnostic and antimicrobial stewardship, but it cannot distinguish whether antibiotics were prescribed for bacteriuria alone or an alternate source of infection, and this metric cannot be electronically captured.Reference Flanders and Saint 54 Process measures like SUR and CA bacteriuria can bring a fresh perspective to those leading quality efforts in acute care and can motivate decision makers to prioritize resources toward avoiding overall device harm and promoting stewardship.
Discussion
Metrics have important implications on the perceived effectiveness of quality improvement efforts. Hospitals are currently incentivized to concentrate their efforts on preventing NHSN CAUTI events, rather than focusing on catheter harm. We advocate broadening the scope to include both infectious and noninfectious catheter complications, analogous to monitoring ventilator-associated events (VAEs). Hospitals are now encouraged to perform surveillance for VAEs, which is a more inclusive outcome than ventilator-associated pneumonia.Reference Magill, Klompas and Balk 55 Evolving to more inclusive metrics provides greater opportunity to educate providers regarding appropriate device utilization and antimicrobial stewardship.Reference Advani, Lee, Schmitz and Camins 5 , Reference Press and Metlay 6 , Reference Fakih, Gould and Trautner 17 , Reference Wright, Kharasch, Beaumont, Peterson and Robicsek 33
No single perfect metric to evaluate patient harm from CAUTIs exists due to the difficulty to clearly define its elements clinically. Surveillance definitions have ranged from the broad definition of CA bacteriuria previously to a very narrow focus recently on high-level bacteriuria and fever. Due to limitations of the current metrics, the focus of quality improvement efforts has shifted to frequency of testing, particularly to how often urine cultures are done. If we expand the scope to all catheter harm, then the SUR would provide a good surrogate for preventable infectious and noninfectious catheter harm. Electronically captured CA bacteriuria adjusted to patient and hospital characteristics can help evaluate the component of testing stewardship. Finally, population SIR is an attractive metric that reflects both infectious and noninfectious harm because it captures efforts to optimize device use and care while adjusting for population risk. Future metrics should shift the focus from purely infection-related injury to all types of catheter-related harm, reflect frequency of testing, and should be electronically captured. Hence, our CAUTI performance metrics need to be refined so that our measurements reflect our efforts to improve patient outcomes.
Author ORCIDs
Sonali D. Advani 0000-0001-5162-6482; Mohamad G. Fakih, 0000-0002-2258-8015
Acknowledgments
The authors would like to acknowledge the ongoing efforts by other researchers and agencies to prevent catheter harm and improve CAUTI metrics.
Financial support
No financial support was provided relevant to this article.
Conflicts of interest
All authors report no conflicts of interest relevant to this article.
