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To describe a pseudo-outbreak of Clostridium difficile infection (CDI) caused by a faulty toxin assay lot and to determine the effect of sensitivity, specificity, and repeated testing for C. difficile on perceived CDI burden, positive predictive value, and false-positive results.
Outbreak investigation and criterion standard.
Patients hospitalized at a tertiary care hospital who had at least 1 toxin assay for detection of C. difficile performed during the period from July 1, 2004, through June 30, 2006.
The run control chart method and the x2 test were used to compare CDI rates and the proportion of positive test results before, during, and after the pseudo-outbreak. The effect of repeated testing was evaluated by using 3 hypothetical models with a sample of 10,000 patients and various assay sensitivity and specificity estimates.
In November of 2005, the CDI rate at the hospital increased from 1.5 to 2.6 cases per 1,000 patient-days (P< .01), and the proportion of positive test results increased from 13.6% to 22.1% (P< .01). An investigation revealed a pseudo-outbreak caused by a faulty toxin assay lot. A decrease of only 1.2% in the specificity of the toxin assay would result in a 32% increase in perceived incidence of CDI at this institution. When calculated by use of the manufacturer's stated specificity and sensitivity and this institution's testing practices, the positive predictive value of the test decreased from 80.6% to 4.1% for patients who received 3 tests.
Specificity is as important as sensitivity when testing for CDI. False-positive CDI cases can drain hospital resources and adversely affect patients. Repeated testing for C. difficile should be performed with caution.
To compare Clostridium difficile infection (CDI) rates determined with use of a traditional definition (ie, with healthcare-onset CDI defined as diagnosis of CDI more than 48 hours after hospital admission) with rates determined with use of expanded definitions, including both healthcare-onset CDI and community-onset CDI, diagnosed within 48 hours after hospital admission in patients who were hospitalized in the previous 30 or 60 days, and to determine whether differences exist between patients with CDI onset in the community and those with CDI onset in a healthcare setting.
Tertiary acute care facility.
General medicine patients who received a diagnosis of CDI during the period January 1, 2004, through December 31, 2005.
CDI was classified as healthcare-onset CDI, healthcare facility–associated CDI after hospitalization within the previous 30 days, and/or healthcare facility-associated CDI after hospitalization within the previous 60 days. Patient demographic characteristics and medication exposures were obtained. The CDI incidence with use of each definition, CDI rate variability, patient demographic characteristics, and medication exposures were compared.
The healthcare-onset CDI rate (1.6 cases per 1,000 patient-days) was significantly lower than the 30-day healthcare facility–associated CDI rate (2.4 cases per 1,000 patient-days; P<.01) and the 60-day healthcare facility–associated CDI rate (2.6 cases per 1,000 patient-days; P<.01). There was good correlation between the healthcare-onset CDI rate and both the 30-day (correlation, 0.69; P<.01) and 60-day (correlation, 0.70; P<.01) healthcare facility–associated CDI rates. There were no months in which the CDI rate was more than 3 standard deviations from the mean. Compared with patients with healthcare-onset CDI, patients with community-onset CDI were less likely to have received a fourth-generation cephalosporin (P = .02) or intravenous vancomycin (P = .01) during hospitalization.
Compared with the traditional definition, expanded definitions identify more patients with CDI. There is good correlation between traditional and expanded CDI definitions; therefore, it is unclear whether expanded surveillance is necessary to identify an abnormal change in CDI rates. Cases that met the expanded definitions were less likely to have occurred in patients with fourth-generation cephalosporin and vancomycin exposure.
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