Organism burden, toxin concentration, and lactoferrin concentration do not distinguish between clinically significant and nonsignificant diarrhea in patients with Clostridium difficile

Anikst, Victoria; Gaur, Rajiv L.; Schroeder, Lee F.; Banaei, Niaz

doi:10.1016/j.diagmicrobio.2015.11.022

Cited by 28 publications

(24 citation statements)

References 32 publications

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“…However, the data are conflicting. Although some studies suggest that patients with positive toxin assays have a worse prognosis than those with a positive NAAT only (1, 2), many other carefully conducted studies involving more than 2,000 patients have not found toxin assays to be predictive of symptoms, disease severity, mortality, transmissibility, or recurrence (11,15,16,38,42,43). In any case, whether the detection of toxin is indicative of a worse prognosis is beside the point.…”

Section: Why Do Studies Of Symptoms and Clinical Outcomes In Patientsmentioning

confidence: 97%

“…As Dubberke and Burnham have noted, one must "treat the patient, not the test" (44). Some patients with positive toxin assays have asymptomatic colonization (37,38), and some patients with negative toxin assays have CDIs (10,11,13,15,16,(40)(41)(42)(43). More than half of patients with symptomatic CDIs would be missed by reliance on a toxin immunoassay (11,15,16,42,43), an unacceptably high proportion of false-negative results.…”

Section: Why Do Studies Of Symptoms and Clinical Outcomes In Patientsmentioning

confidence: 99%

“…With regard to specificity, it is important to recognize that no C. difficile diagnostic assay is completely specific for clinical disease. Production of toxin is essential but not sufficient for disease, and even patients with high fecal toxin levels may be asymptomatic (37,38), particularly if they have toxin-neutralizing antibodies (39). With regard to sensitivity, it is equally important to recognize that toxin assays can be negative in patients with symptomatic (and even life-threatening) CDIs (10,13,40,41).…”

Section: Why Do Studies Of Symptoms and Clinical Outcomes In Patientsmentioning

confidence: 99%

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Point-Counterpoint: What Is the Optimal Approach for Detection of Clostridium difficile Infection?

2017

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INTRODUCTION In 2010, we published an initial Point-Counterpoint on the laboratory diagnosis of Clostridium difficile infection (CDI). At that time, nucleic acid amplification tests (NAATs) were just becoming commercially available, and the idea of algorithmic approaches to CDI was being explored. Now, there are numerous NAATs in the marketplace, and based on recent proficiency test surveys, they have become the predominant method used for CDI diagnosis in the United States. At the same time, there is a body of literature that suggests that NAATs lack clinical specificity and thus inflate CDI rates. Hospital administrators are taking note of institutional CDI rates because they are publicly reported. They have become an important metric impacting hospital safety ratings and value-based purchasing; hospitals may have millions of dollars of reimbursement at risk. In this Point-Counterpoint using a frequently asked question approach, Ferric Fang of the University of Washington, who has been a consistent advocate for a NAAT-only approach for CDI diagnosis, will discuss the value of a NAAT-only approach, while Christopher Polage of the University of California Davis and Mark Wilcox of Leeds University, Leeds, United Kingdom, each of whom has recently written important articles on the value of toxin detection in the diagnosis, will discuss the impact of toxin detection in CDI diagnosis.

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Section: Why Do Studies Of Symptoms and Clinical Outcomes In Patientsmentioning

confidence: 97%

Section: Why Do Studies Of Symptoms and Clinical Outcomes In Patientsmentioning

confidence: 99%

Section: Why Do Studies Of Symptoms and Clinical Outcomes In Patientsmentioning

confidence: 99%

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Point-Counterpoint: What Is the Optimal Approach for Detection of Clostridium difficile Infection?

2017

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“…Anikst et al[122] suggests the implementation of measures to avoid unnecessary testing for C. difficile in order to diminish CDI overdiagnosis. The identification of such a biomarker, will be helpful to improve CDI diagnosis.…”

Section: Biomarkersmentioning

confidence: 99%

Current knowledge on the laboratory diagnosis ofClostridium difficileinfection

Martínez-Meléndez¹,

Camacho-Ortíz²,

Morfín‐Otero³

et al. 2017

WJG

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Clostridium difficile (C. difficile) is a spore-forming, toxin-producing, gram-positive anaerobic bacterium that is the principal etiologic agent of antibiotic-associated diarrhea. Infection with C. difficile (CDI) is characterized by diarrhea in clinical syndromes that vary from self-limited to mild or severe. Since its initial recognition as the causative agent of pseudomembranous colitis, C. difficile has spread around the world. CDI is one of the most common healthcare-associated infections and a significant cause of morbidity and mortality among older adult hospitalized patients. Due to extensive antibiotic usage, the number of CDIs has increased. Diagnosis of CDI is often difficult and has a substantial impact on the management of patients with the disease, mainly with regards to antibiotic management. The diagnosis of CDI is primarily based on the clinical signs and symptoms and is only confirmed by laboratory testing. Despite the high burden of CDI and the increasing interest in the disease, episodes of CDI are often misdiagnosed. The reasons for misdiagnosis are the lack of clinical suspicion or the use of inappropriate tests. The proper diagnosis of CDI reduces transmission, prevents inadequate or unnecessary treatments, and assures best antibiotic treatment. We review the options for the laboratory diagnosis of CDI within the settings of the most accepted guidelines for CDI diagnosis, treatment, and prevention of CDI.

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“…Laxative therapy was also documented in up to 50% of patients undergoing testing or diagnosed with CDI in some studies (13,14,16). Furthermore, in some studies, 100% of patients with positive C. difficile results were treated for CDI whether diarrhea was present or not (16,18). Combined with the fact that most cases of nosocomial diarrhea have a noninfectious etiology (19), current testing practices lead to inappropriate C. difficile diagnosis and overtreatment.…”

mentioning

confidence: 99%

Real-Time Electronic Tracking of Diarrheal Episodes and Laxative Therapy Enables Verification of Clostridium difficile Clinical Testing Criteria and Reduction of Clostridium difficile Infection Rates

et al. 2017

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Health care-onset health care facility-associated Clostridium difficile infection (HO-CDI) is overdiagnosed for several reasons, including the high prevalence of C. difficile colonization and the inability of hospitals to limit testing to patients with clinically significant diarrhea. We conducted a quasiexperimental study from 22 June 2015 to 30 June 2016 on consecutive inpatients with C. difficile test orders at an academic hospital. Real-time electronic patient data tracking was used by the laboratory to enforce testing criteria (defined as the presence of diarrhea [Ն3 unformed stools in 24 h] and absence of laxative intake in the prior 48 h). Outcome measures included C. difficile test utilization, HO-CDI incidence, oral vancomycin utilization, and clinical complications. During the intervention, 7.1% (164) and 9.1% (211) of 2,321 C. difficile test orders were canceled due to absence of diarrhea and receipt of laxative therapy, respectively. C. difficile test utilization decreased upon implementation from an average of 208.8 tests to 143.0 tests per 10,000 patient-days (P Ͻ 0.001). HO-CDI incidence rate decreased from an average of 13.0 cases to 9.7 cases per 10,000 patient-days (P ϭ 0.008). Oral vancomycin days of therapy decreased from an average of 13.8 days to 9.4 days per 1,000 patient-days (P ϭ 0.009). Clinical complication rates were not significantly different in patients with 375 canceled orders compared with 869 episodes with diarrhea but negative C. difficile results. Realtime electronic clinical data tracking is an effective tool for verification of C. difficile clinical testing criteria and safe reduction of inflated HO-CDI rates.KEYWORDS Clostridium difficile, data tracking, evidence-based medicine, verification C lostridium difficile is the most common identifiable cause of antibiotic-associated diarrhea (1). Clostridium difficile infection (CDI) is estimated to be the most expensive health care-associated infection, costing the U.S. health system $5.4 billion annually (2). A major challenge with accurate diagnosis of CDI is the high prevalence of C. difficile colonization. Studies indicate that 4.4% to 21% of hospitalized patients are asymptomatically colonized with toxigenic C. difficile (3-10, 30). In the absence of disease-specific

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Organism burden, toxin concentration, and lactoferrin concentration do not distinguish between clinically significant and nonsignificant diarrhea in patients with Clostridium difficile

Cited by 28 publications

References 32 publications

Point-Counterpoint: What Is the Optimal Approach for Detection of Clostridium difficile Infection?

Point-Counterpoint: What Is the Optimal Approach for Detection of Clostridium difficile Infection?

Current knowledge on the laboratory diagnosis ofClostridium difficileinfection

Real-Time Electronic Tracking of Diarrheal Episodes and Laxative Therapy Enables Verification of Clostridium difficile Clinical Testing Criteria and Reduction of Clostridium difficile Infection Rates

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