scholarly journals Clostridium difficile Laboratory Identification Event Reporting – A Need for Diagnostic Stewardship

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S398-S399
Author(s):  
Clare Rock ◽  
Zoi Pana ◽  
Surbhi Leekha ◽  
Polly Trexler ◽  
Jennifer Andonian ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Medical Records ◽  
Chart Review ◽  
Nucleic Acid Amplification ◽  
Event Reporting ◽  
Laxative Use ◽  
Academic Center ◽  
The Us ◽  
Clinically Significant ◽  
Present On Admission

Abstract Background Clostridium difficile LabID event reporting uses electronic laboratory results without chart review. Nucleic acid amplification testing is common in the US. A positive result may represent colonization or C. diff infection (CDI). We review C.difflabID events to ascertain if Hospital-Onest CDI (HO CDI). For non-HO CDI, we identify reason and use a matrix to prioritize clinical areas for intervention efforts. Methods Each C. difflab ID event from Jan 2015 to June 2016 at academic center had chart review for HO CDI; defined significant diarrhea, not present on admission, with no laxatives in prior 48 hours. For non HO-CDI events, reason and receipt of antibiotic treatment within 14 days of the positive test were retrospectively noted. A prioritization matrix, where clinical services were ranked according to number of lab ID events (service’s contribution to the facility C. diffLabID), was multiplied by a rank based on percent of inappropriate tests giving an overall prioritization score for where intervention resources could potentially best be used. Results There were 490 C difficile LabID events; 284 (58%) were HO-CDI; 206 (42%) were inappropriate or delayed testing. Of the 190 with available medical records at time of retrospective review, reasons for not meeting the HO-CDI included laxative use within the previous 48 hours (41%), no clinically significant diarrhea (49.5%); delayed testing (9.5%). See figure. Of 172 patients with inappropriate testing, 159 (92%) were treated for CDI. Medicine and psychiatry ranked first and second on prioritization matrix. See table. Conclusion Nearly half of C. diff LabID events were not true HO CDI, but inappropriate or delayed tests. Prioritization matrix identified medicine and psychiatry as areas where diagnostic stewardship interventions could affect most on facility C. diff LabID. Disclosures K. C. Carroll, GenePOC, Inc.: Grant Investigator, Grant recipient

scholarly journals Strategies for Optimizing the Diagnostic Predictive Value of Clostridium difficile Molecular Diagnostics

2017 ◽  
Vol 55 (5) ◽  
pp. 1244-1248 ◽  
Author(s):  
Larry K. Kociolek
Keyword(s):  
Clostridium Difficile ◽  
Predictive Value ◽  
Clinical Microbiology ◽  
Nucleic Acid Amplification ◽  
Oral Vancomycin ◽  
Content Type ◽  
Clinical Bioinformatics ◽  
Laxative Use ◽  
Low Probability ◽  
Clinically Significant

ABSTRACT Because nucleic acid amplification tests (NAATs) do not distinguish Clostridium difficile infection (CDI) and asymptomatic C. difficile carriage, the diagnostic predictive value of NAATs is limited when used in patients with a low probability of CDI. In this issue of the Journal of Clinical Microbiology , Truong et al. (J. Clin. Microbiol., 55:1276–1284, 2017, https://doi.org/10.1128/JCM.02319-16 ) report significant reductions in hospital-onset CDI and oral vancomycin utilization at their institution following implementation of a novel intervention that leveraged their clinical bioinformatics resources to prevent C. difficile testing of stools from patients without clinically significant diarrhea and in patients with recent laxative use.

scholarly journals 2345. Reduction in Testing and Change in Testing Algorithm Associated with Decrease in Number of Nosocomial Clostridium difficile Infections

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S806-S806
Author(s):  
Susan Nichols ◽  
Michelle D Jordan ◽  
Michael Coogan ◽  
Jackie Opera ◽  
Paul P Cook
Keyword(s):  
Clostridium Difficile ◽  
Best Practice ◽  
Medical Center ◽  
Nucleic Acid Amplification ◽  
Antimicrobial Use ◽  
Continuous Variables ◽  
Laxative Use ◽  
Days Of Therapy ◽  
Before And After ◽  
Testing Algorithm

Abstract Background Previous data at our facility indicated 37% of patients with Clostridium difficile infection (CDI) were receiving at least one laxative at the time of testing, suggesting the possibility of false-positive results. Nucleic acid amplification testing (NAAT) does not distinguish between colonization and infection with C. difficile. We implemented two interventions to address these issues and evaluated our rates of nosocomial CDI before and after these changes. Methods This was a retrospective study of all positive test results for adult patients with nosocomial C. difficile from October 1, 2017 through March 31, 2019 at Vidant Medical Center, a 911-bed hospital. In June, 2018, we implemented a best practice advisory (BPA) in our electronic health record to recommend against testing for CDI in patients receiving laxatives. We reviewed the number of C. difficile tests ordered before and after initiating the BPA. In December, 2018, we removed NAAT and replaced it with a cell cytotoxicity assay (CCA) for specimens that were enzyme immunoassay (EIA) negative and glutamate dehydrogenase (GDH) positive. Antimicrobial use was measured in days of therapy (DOT) per 10,000 patient-days (PD). Mann–Whitney U test was used for continuous variables. Linear regression was used to monitor antimicrobial use. Results The number of C. difficile tests ordered per month decreased 19.5% after implementing the BPA (P < 0.0001). There was a 44% reduction in the number of EIA+/GDH+ specimens per month after the BPA intervention (P = 0.003). Following substitution of CCA for NAAT for EIA-/GDH+ specimens, there was a 61% reduction in the rate of nosocomial CDI (8.6 cases/10,000 PD to 3.3 cases/10,000 PD; P = 0.005). Total antimicrobial use was unchanged over the course of the study (673 to 677 DOT/10,000 PD). Carbapenem use decreased 56% (P = 0.009); cefepime use increased 85%(p = 0.002); quinolone and clindamycin use were unchanged. Conclusion Laxative use in hospitalized patients is common and likely contributes to a false elevation in the CDI rate by identifying carriers in addition to those who have true infection. Implementing a BPA to reduce inappropriate testing and changing our testing algorithm for Clostridium difficile by substituting CCA for NAAT has resulted in a lower rate of nosocomial CDI. Disclosures All authors: No reported disclosures.

Failure of Risk-Adjustment by Test Method for C. difficile Laboratory-Identified Event Reporting

2016 ◽  
Vol 38 (1) ◽  
pp. 109-111 ◽  
Author(s):  
Alexandre R. Marra ◽  
Michael B. Edmond ◽  
Bradley A. Ford ◽  
Loreen A. Herwaldt ◽  
Abdullah R. Algwizani ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Clostridium Difficile ◽  
Enzyme Immunoassay ◽  
Risk Adjustment ◽  
Test Method ◽  
Infect Control Hosp ◽  
Nucleic Acid Amplification ◽  
Event Reporting ◽  
Current Risk

Using an algorithm including both enzyme immunoassay (EIA) and nucleic acid amplification (NAAT) for Clostridium difficile infection (CDI) diagnosis, we found that the use of NAAT versus EIA almost doubled our hospital-onset CDI laboratory-identified (LabID) event standardized infection ratio (SIR). We recommend that the current risk adjustment approach be modified.Infect Control Hosp Epidemiol 2016:1–3

scholarly journals Performing Reflexive Toxin A/B Enzyme Immunoassay in a Two-Step Algorithm for the Diagnosis of Clostridium difficile Infection Has Limited Clinical Utility

2018 ◽  
Author(s):  
M Mounajjed ◽  
R Pease ◽  
B Jung-Hynes ◽  
N Safdar ◽  
D Chen
Keyword(s):  
Clostridium Difficile ◽  
Enzyme Immunoassay ◽  
Electronic Medical Records ◽  
Medical Records ◽  
Clinical Utility ◽  
Nucleic Acid Amplification ◽  
Toxin B ◽  
Clinical Sensitivity ◽  
Stool Samples ◽  
Step Algorithm

ABSTRACTThe differentiation of Clostridium difficile infection (CDI) from colonization is challenged by the suboptimal clinical specificity of nucleic acid amplification tests (NAAT). In this study, we examined the utility of testing for toxin via enzyme immunoassay (EIA) in specimens already tested by NAAT for the diagnosis of CDI in an attempt to differentiate colonization from infection. We tested 59 stool samples for the presence of C. difficile toxin B gene by NAAT followed by EIAs for glutamate dehydrogenase (GDH EIA) and toxins A and B (Toxin EIA). Two infectious disease physicians independently reviewed the patients’ electronic medical records retrospectively to categorize each patient as CDI-Likely, CDI-Unlikely, or CDI-Indeterminate. Clinical sensitivities and specificities were calculated using 3 definitions of “true” CDI status, being: (1) concordance between both reviewers, (2) concordance, and CDI-Indeterminate/discordant cases classified as CDI-Likely, and (3) concordance, and CDI-Indeterminate/discordant cases classified as CDI-Unlikely. Based on these definitions, clinical sensitivity and specificity for NAAT was 100% and 49-94%, GDH EIA was 83-85% and 43-89%, and Toxin EIA was 39-42% and 83-100%, respectively. 85% (22 of 26) of patients who were NAAT-positive but Toxin EIA-negative symptomatically benefited from treatment for CDI. The addition of EIA to NAAT for CDI diagnosis had limited utility for differentiating colonization from CDI and could have led to under treatment of patients with CDI.

scholarly journals 2426. Performance of Statistical Process Control Charts for Detecting Clinically-Significant Increases in Clostridium difficile Infection Rates

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S838-S839
Author(s):  
Nicole Nehls ◽  
Anthony Bilantuono ◽  
Christian Etherton ◽  
Iulian Ilieş ◽  
James C Benneyan ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Process Control ◽  
Statistical Process Control ◽  
The United States ◽  
Nucleic Acid Amplification ◽  
Global Network ◽  
Enzyme Linked Immunosorbent Assay ◽  
Healthcare Associated Infection ◽  
Statistical Process ◽  
Clinically Significant

Abstract Background Clostridium difficile infections (CDIs) are the most common type of healthcare-associated infection in the United States, with an estimated annual incidence of 500,000 cases and excess healthcare costs of $5 billion per year. The prevalence and severity of CDIs have been increasing in recent years, making it of vital importance to detect outbreaks sufficiently early to minimize negative health outcomes. Statistical process control (SPC) methods have proven to be a versatile tool in healthcare, enabling near real-time monitoring of adverse events rates and thereby improving patients’ health. The aim of this study was to investigate the performance of SPC in detecting clinically significant increases in CDI rates. Methods We retrospectively analyzed monthly CDI rates at 6 community hospitals in the Duke Infection Control Outreach Network from 2009–2017. Detected CDIs were stratified by surveillance system (LabID or traditional), infection source, recurrence type, and diagnostic test (nucleic acid amplification or enzyme-linked immunosorbent assay). Recurrent and community-associated CDIs were excluded from all analyses. Several variations of Shewhart and exponentially-weighted moving average (EWMA) u-charts were applied to each hospital (Figure 1), including using different baseline types (global, fixed, or rolling) and baseline data streams (hospital or network-wide). To help assess chart performance, epidemiologists determined the clinical relevance (yes/no) of 167 statistical signals generated using earlier iterations of these charts. Performance was quantified via sensitivity, specificity, and accuracy. Results EWMA u-charts with global network-wide baselines performed the best (Figure 2), detecting the largest number of clinically relevant signals (56% sensitivity) with high specificity (96%). Charts utilizing network-wide baselines were generally more accurate than those using local hospital data for that purpose (accuracy of 46–72% vs. 43–45%). Similarly, charts with fixed baselines performed better than those with rolling ones (accuracy of 43–62% vs. 43–47%). Conclusion SPC charts are easily applicable to CDI surveillance; however, their parameters would need to be optimized to maximize utility. Disclosures All authors: No reported disclosures.

scholarly journals 2343. How Smart Is the Chart? Accuracy of the Medical Record in Documenting Diarrhea in Patients Tested for Clostridium difficile Infection

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S805-S805
Author(s):  
Gavriella Pora ◽  
Y Karen Ng Wong ◽  
Lucy Jury ◽  
Curtis Donskey
Keyword(s):  
Clostridium Difficile ◽  
Medical Record ◽  
Clostridium Difficile Infection ◽  
Chart Review ◽  
Alternative Explanation ◽  
Patient Interviews ◽  
Education Of Patients ◽  
Bowel Movements ◽  
Clinically Significant ◽  
Current Guidelines

Abstract Background Inappropriate testing for Clostridium difficile infection (CDI) may result in diagnosis of CDI in asymptomatic carriers with diarrhea due to other causes such as laxatives. Current guidelines suggest that periodic chart review may be useful to assess the appropriateness of CDI testing, but it is not known how accurate the medical record is in documenting diarrhea. Methods We conducted a prospective cohort study of 80 patients tested for CDI to determine the accuracy of diarrhea documentation in the medical record in comparison to patient interviews and to assess the appropriateness of testing. Results Thirty-five of 80 (44%) CDI tests were deemed inappropriate because patients either did not have clinically significant diarrhea (i.e., 3 or more unformed stools per day) or had an alternative explanation for diarrhea. Seventy-four of 80 (93%) patients stated they had diarrhea, but only 53 (66%) had clinically significant diarrhea based on symptom review. Physician and/or nursing notes documented diarrhea in 67 of 80 (84%) patients, but the number of bowel movements and the consistency of stool were documented for only 36 (45%) and 41 (51%) patients. Conclusion In our facility, inappropriate CDI testing was common and the accuracy of the medical record in documenting diarrhea was suboptimal. Education of patients and providers may be beneficial in improving the accuracy of diarrhea documentation and the appropriateness of testing. Disclosures All authors: No reported disclosures.

scholarly journals Enzyme Immunoassay for C. difficile Toxin Reduces Lab ID Events but Fails to Detect Clinically Significant C. difficile Infection

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S398-S398
Author(s):  
Jessica P Ridgway ◽  
Cynthia Murillo ◽  
Rachel Marrs ◽  
Sylvia Garcia-Houchins ◽  
Clinitka Harper ◽  
...  
Keyword(s):  
Enzyme Immunoassay ◽  
Chart Review ◽  
Nucleic Acid Amplification ◽  
Clinical Tests ◽  
Chain Reaction ◽  
Two Stage ◽  
Significant Difference ◽  
Polymerase Chain ◽  
Clinically Significant ◽  
Testing Algorithm

Abstract Background The National Health Safety Network (NHSN) requires reporting of Lab ID events for C. difficile infection (CDI) including all positive clinical tests after day three of hospitalization. Nucleic acid amplification tests (NAAT) that detect genes for toxins A and/or B may be overly sensitive, in some cases detecting C. difficile colonization. Some have advocated for two-stage testing, with positive NAAT tests followed by confirmatory enzyme immunoassay (EIA) to detect the presence of toxin and minimize the downside of false positives (i.e. additional NHSN reports or overuse of antibiotics). We aimed to better understand clinical characteristics of patients with positive NAAT and/or EIA tests. Methods Our hospital uses Xpert C. difficile assay (Cepheid), a NAAT method utilizing polymerase chain reaction (PCR), to diagnose CDI on unformed stool only. As part of a 6 month quality initiative, we pilot tested the C.DIFF QUIK CHEK COMPLETE® test (Alere), an EIA that tests for C. difficileantigen (Ag) and toxin, on all specimens that tested positive by NAAT. We abstracted clinical data from the medical record for a subset of patients who underwent EIA testing. Results Over 6 months, 294 patients had a positive test by NAAT. Of these, 258 (87.8%) underwent EIA testing. 67 (26.0%) were Ag+/toxin+, 173 (67.1%) were Ag+/toxin-, and 18 (6.8%) were Ag-/toxin-. Mortality rates were as follows: Ag+/toxin+, 17.9% (12/67); Ag+/toxin-, 13.9% (24/173); Ag-/toxin-, 27.8% (5/18), P = 0.27. Among the EIA toxin negative patients who underwent chart review, 81% had 3 or more loose stools within 24 hours, 62% had abdominal pain, nausea, or vomiting, and 27% had a WBC &gt; 15. Conclusion The majority of patients testing positive for CDI by NAAT had a negative EIA test for toxin. There was no significant difference in mortality between EIA toxin positive and negative. Those with negative EIA toxin tests often had clinically significant symptoms of CDI. A two-stage CDI testing algorithm with NAAT followed by EIA for toxin may exclude patients with clinically significant CDI but would have resulted in a 75% reduction in reported NHSN LabID events. Disclosures All authors: No reported disclosures.

scholarly journals Cardiovascular Safety Profile of Romosozumab: A Pharmacovigilance Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS)

2021 ◽  
Vol 10 (8) ◽  
pp. 1660
Author(s):  
Annika Vestergaard Kvist ◽  
Junaid Faruque ◽  
Enriqueta Vallejo-Yagüe ◽  
Stefan Weiler ◽  
Elizabeth M. Winter ◽  
...  
Keyword(s):  
Adverse Event ◽  
Drug Administration ◽  
Cardiovascular Events ◽  
Reporting System ◽  
Food And Drug Administration ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Cardiovascular Safety ◽  
Event Reporting ◽  
The Us

Background: Cardiovascular safety concerns for major cardiovascular events (MACE) were raised during the clinical trials of romosozumab. We aimed to evaluate the cardiovascular safety profile of romosozumab in a large pharmacovigilance database. Methods: All cases reported between January 2019 and December 2020 where romosozumab was reported were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). The outcome of interest was MACE (myocardial infarction (MI), stroke, or cardiovascular death). A disproportionality analysis was conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals. Disproportionality analyses were stratified by sex and reporting region (US, Japan, other). Results: Of the 1995 eligible cases with romosozumab, the majority (N = 1188; 59.5%) originated from Japan. Overall, 206 suspected MACE reports were identified, of which the majority (n = 164; 13.8%) were from Japan, and 41 (5.2%) were from the United States (US). Among Japanese reports, patients were older and more frequently male than reports from the US. Similarly, cases with a reported MACE were older and had higher reports of cardioprotective drugs than those without cardiovascular events. Elevated reports for MACE (ROR 4.07, 95% CI: 2.39–6.93) was identified overall, which was primarily driven by the significant disproportionality measures in the Japanese reports. Conclusions: The current pharmacovigilance study identified a potential signal for elevated MACE, particularly in Japan. The results support the current safety warnings from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to avoid use in high-risk patients.

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