scholarly journals 100. Development and Implementation of a 2-Tier Testing Algorithm for Clostridioides difficile: An Evaluation of Outcomes on Patients with Indeterminate Results at 90 Days

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S64-S65
Author(s):  
Johanna P Brown ◽  
Stephanie Puckett
Keyword(s):  
Final Analysis ◽  
Indeterminate Result ◽  
Provider Education ◽  
Ample Evidence ◽  
Daily Monitoring ◽  
Clostridioides Difficile ◽  
Stool Samples ◽  
Low Incidence ◽  
True Infection ◽  
Testing Algorithm

Abstract Background There is no definitive gold standard for accurate diagnosis of Clostridioides difficile (C difficile) infection. There is ample evidence that relying on a molecular test such as Polymerase Chain Reaction (PCR) for diagnosis, can lead to over diagnosis and unnecessary treatment. Combined, multi-step algorithms have been proposed to improve specificity of testing. The challenge remains in interpreting discordant or indeterminate results. Additionally, the risk of hospitalization due to lack of treatment for indeterminate results remains unclear. Methods To improve C difficile testing, a new 2-tier algorithm was implemented in 2019 starting with PCR testing. An indeterminate result was defined as a sample with a positive PCR and a positive Glutamate Dehydrogenase (GDH)/negative toxin result or a positive PCR and a negative GDH/positive toxin result. Indeterminate results were classified by episode severity and number. Patient records were reviewed by the Antimicrobial Stewardship (AS) physician and pharmacist to determine true infection versus colonization. Treatment was given as per recent IDSA Guidelines. All patients with indeterminate results were followed for 90 days for development of infection or hospitalization due to C difficile. Adults with stool samples submitted for testing between 6/1/2019 and 12/31/2019 were included. A total of 169 specimens were reviewed: 75 were positive, 72 were indeterminate (4 excluded from final analysis) and 22 were negative. Results Using a 2-tier testing algorithm, 68 (41%) of all results were indeterminate. Our AS classified 47 (69%) of those as infection and 21 (31%) as colonization. Patients with indeterminate results who were treated had a low incidence (8.5%) of reinfection requiring hospitalization in the following 90 days. There were no hospitalizations in the untreated group. Of patients with an indeterminate result who were treated, 42 (89%) were categorized as an initial episode of C difficile infection. Conclusion Clinical correlation of indeterminate results is critical to algorithm interpretation. A combined approach with provider education, an electronic testing advisor, a 2-tier testing algorithm, daily monitoring and prescribing by the AS team resulted in favorable outcomes for patients with indeterminate results Disclosures All Authors: No reported disclosures

scholarly journals Impact of Two-Step Testing Algorithm on Reducing Hospital-Onset Clostridioides difficile Infections

2021 ◽  
Vol 1 (S1) ◽  
pp. s42-s43
Author(s):  
Bhagyashri Navalkele ◽  
Wendy Winn ◽  
Sheila Fletcher ◽  
Regina Galloway ◽  
Jason Parham ◽  
...  
Keyword(s):  
Medical Center ◽  
Molecular Testing ◽  
Toxin A ◽  
Clostridioides Difficile ◽  
Contact Isolation ◽  
Academic Center ◽  
Mississippi Medical ◽  
True Infection ◽  
Testing Algorithm ◽  
The University

Clostridioides difficile infection (CDI) is one of the leading causes of hospital–onset infections. Clinically distinguishing true CDI versus colonization with C. difficile is challenging and often requires reliable and rapid molecular testing methods. At our academic center, we implemented a 2-step testing algorithm to help identify true CDI cases. The University of Mississippi Medical Center is a 700+ bed academic facility located in Jackson, Mississippi. Hospital-onset (HO) CDI was defined based on NHSN Laboratory Identified (LabID) event as the last positive C. difficile test result performed on a specimen using a multistep testing algorithm collected >3 calendar days after admission to the facility. HO-CDI data were collected from all inpatient units except the NICU and newborn nursery. HO-CDI outcomes were assessed based on standardized infection ratio (SIR) data. In May 2020, we implemented a 2-step testing algorithm (Figure 1). All patients with diarrhea underwent C. difficile PCR testing. Those with positive C. difficile PCR test were reflexed to undergo enzyme immunoassay (EIA) glutamate dehydrogenase antigen (Ag) testing and toxin A and B testing. The final results were reported as colonization (C. difficile PCR+/EIA Ag+/Toxin A/B−) or true CDI case (C. difficile PCR+/EIA +/Toxin A/B +) or negative (C. difficile PCR−). All patients with colonization or true infection were placed under contact isolation precautions until diarrhea resolution for 48 hours. During the preintervention period (October 2019–April 2020), 25 HO-CDI cases were reported compared to 8 cases in the postintervention period (June 2020–December 2020). A reduction in CDI SIR occurred in the postintervention period (Q3 2020–Q4 2020, SIR 0.265) compared to preintervention period (Q4 2019–Q1 2020, SIR 0.338) (Figure 2). We successfully reduced our NHSN HO-CDI SIR below the national average after implementing a 2-step testing algorithm for CDI. The 2-step testing algorithm was useful for antimicrobial stewardship to guide appropriate CDI treatment for true cases and for infection prevention to continue isolation of infected and colonized cases to reduce the spread of C. difficile spores.Funding: NoDisclosures: None

scholarly journals High Agreement Between an Ultrasensitive Clostridioides difficile Toxin Assay and a C. difficile Laboratory Algorithm Utilizing GDH-and-Toxin Enzyme Immunoassays and Cytotoxin Testing

2019 ◽  
Vol 58 (2) ◽  
Author(s):  
Marie L. Landry ◽  
Jeffrey E. Topal ◽  
Joel Estis ◽  
Phoebe Katzenbach ◽  
Niamh Nolan ◽  
...  
Keyword(s):  
Standard Of Care ◽  
Neutralization Assay ◽  
High Agreement ◽  
Content Type ◽  
Clostridioides Difficile ◽  
Automated Assay ◽  
Toxin Assay ◽  
Stool Samples ◽  
Testing Algorithm ◽  
Positive Agreement

ABSTRACT The Singulex Clarity C. diff toxins A/B (Clarity) assay is an automated, ultrasensitive immunoassay for the detection of Clostridioides difficile toxins in stool. In this study, the performance of the Clarity assay was compared to that of a multistep algorithm using an enzyme immunoassay (EIA) for detection of glutamate dehydrogenase (GDH) and toxins A and B arbitrated by a semiquantitative cell cytotoxicity neutralization assay (CCNA). The performance of the assay was evaluated using 211 residual deidentified stool samples tested with a GDH-and-toxin EIA (C. Diff Quik Chek Complete; Techlab), with GDH-and-toxin discordant samples tested with CCNA. The stool samples were stored at –80°C before being tested with the Clarity assay. For samples discordant between Clarity and the standard-of-care algorithm, the samples were tested with PCR (Xpert C. difficile; Cepheid), and chart review was performed. The testing algorithm resulted in 34 GDH+/toxin+, 53 GDH−/toxin−, and 124 GDH+/toxin− samples, of which 39 were CCNA+ and 85 were CCNA−. Clarity had 96.2% negative agreement with GDH−/toxin− samples, 100% positive agreement with GDH+/toxin+ samples, and 95.3% agreement with GDH+/toxin−/CCNA− samples. The Clarity result was invalid for one sample. Clarity agreed with 61.5% of GDH+/toxin−/CCNA+ samples, 90.0% of GDH+/toxin−/CCNA+ (high-positive) samples, and 31.6% of GDH+/toxin−/CCNA+ (low-positive) samples. The Singulex Clarity C. diff toxins A/B assay demonstrated high agreement with a testing algorithm utilizing a GDH-and-toxin EIA and CCNA. This novel automated assay may offer an accurate, stand-alone solution for C. difficile infection (CDI) diagnostics, and further prospective clinical studies are merited.

scholarly journals Systematic Literature Review on Burden of Clostridioides difficile Infection in India

2021 ◽  
Vol 14 ◽  
pp. 2632010X2110138
Author(s):  
Canna J Ghia ◽  
Shaumil Waghela ◽  
Gautam S Rambhad
Keyword(s):  
Risk Factors ◽  
Multiple Testing ◽  
Final Analysis ◽  
Antibiotic Usage ◽  
Diagnostic Methods ◽  
North India ◽  
Enzyme Linked Immunosorbent Assay ◽  
Chi Square ◽  
Clostridioides Difficile ◽  
The Impact

Background: Owing to limited diagnostic facilities and surveillance protocols, there is a paucity on the prevalence data of Clostridioides difficile infections (CDIs) in developing countries such as India. Objective: The aims of these studies are (1) to determine the prevalence of CDI in India, (2) to understand the risk factors of CDI, and (3) to determine the impact of different diagnostic methods on reported CDI rates. Method: A systematic literature search was conducted using PubMed and Google Scholar database to identify Indian studies reporting the prevalence of CDI. A total of 31 studies, published between 1990 and 2020 were included in the final analysis. A chi-square test was used to determine statistically significant association between prevalence rates, accuracy of different diagnosis methods, and antibiotic usage rates of CDI. Results: The prevalence of CDI was in the range of 3.4% to 18%, and the difference between regional prevalence of CDI was statistically significant ( P < .001). The use of antibiotics, hospital stay, comorbidities, recent surgery, and the use of proton-pump inhibitors was considered as risk factors for the development of CDI. Compared to other regions, the rate of antibiotic usage was significantly higher in North India ( P < .001). Among different diagnostic methods, C. difficile detection was significantly higher with enzyme-linked immunosorbent assay (18.02%) versus other multiple testing methods used ( P < .001). Conclusion: There is a significant burden of CDI across the country. Further surveillance studies are required to monitor changes in prevalence of CDI, risk factors, and accuracy of diagnosis methods for a better understanding of the disease burden in India.

scholarly journals Bile Acid Profile and its Changes in Response to Cefoperazone Treatment in MR1 Deficient Mice

Metabolites ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. 127 ◽  
Author(s):  
Jinchun Sun ◽  
Zhijun Cao ◽  
Ashley D. Smith ◽  
Paul E. Carlson Jr ◽  
Michael Coryell ◽  
...  
Keyword(s):  
Bile Acid ◽  
Intestinal Content ◽  
Knock Out ◽  
Mait Cells ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
Infection Resistance ◽  
Stool Samples ◽  
Cecum Content ◽  
Microbiome Data

Mucosal associated invariant T-cells (MAIT cells) are activated following recognition of bacterial antigens (riboflavin intermediates) presented on major histocompatibility complex class I-related molecule (MR1). Our previous study showed that MR1−/− knock-out (KO) mice (lacking MAIT cells) harbor a unique microbiota that is resistant to antibiotic disruption and Clostridioides difficile colonization. While we have characterized the microbiota of this mouse strain, changes in global metabolic activity in these KO mice have not been assessed. Here, LC/MS-based untargeted metabolomics was applied to investigate the differences in the metabolome, specifically in the bile acid (BA) profile of wild-type (WT) and MR1−/− KO mice, as well as how antibiotics change these profiles. BA changes were evaluated in the intestinal content, cecum content, and stool samples from MR1−/− mice and WT mice treated with cefoperazone (Cef). Fecal pellets were collected daily and both intestinal and cecal contents were harvested at predetermined endpoints on day 0 (D0), day 1 (D1), day 3 (D3), and day 5 (D5). KO mice exhibited no changes in 6-hydroxymethyl-8-D-ribityllumazine (rRL-6-CH2OH; an MR1-restricted riboflavin derivative) in the stool samples at either time point vs. D0, while WT mice showed significant decreases in rRL-6-CH2OH in the stool samples on all treatment days vs. D0. Metabolomics analysis from cecal and stool samples showed that KO mice had more total BA intensity (KO/WT = ~1.7 and ~3.3 fold higher) than that from WT mice prior to Cef treatment, while the fold change difference (KO/WT = ~4.5 and ~4.4 fold) increased after five days of Cef treatment. Both KO and WT mice showed decreases in total BA intensity in response to Cef treatment, however, less dramatic decreases were present in KO vs. WT mice. Increases in taurocholic acid (TCA) intensity and decreases in deoxycholic acid (DCA) intensity in the stool samples from WT mice were associated with the depletion of certain gut bacteria, which was consistent with the previously reported microbiome data. Furthermore, the non-detected TCA and relatively higher DCA intensity in the KO mice might be related to Clostridioides difficile infection resistance, although this needs further investigation.

scholarly journals 754. A Two-step Testing Algorithm for Hospital-onset Clostridioides difficile Infection (CDI) Reduces Prescribing of C. difficile (CD) Therapy but Its Ability to Guide Treatment Decisions Remains Unclear

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S474-S474
Author(s):  
Mackenzie Dolan ◽  
Heather Cox ◽  
Cirle A Warren ◽  
Costi Sifri ◽  
Melinda Poulter ◽  
...  
Keyword(s):  
Decision Support Tool ◽  
Treatment Decisions ◽  
Adverse Outcomes ◽  
Nucleic Acid Amplification ◽  
Test Results ◽  
Patient Death ◽  
Support Tool ◽  
Clostridioides Difficile ◽  
Days Of Therapy ◽  
Testing Algorithm

Abstract Background Determining true CDI versus CD colonization through CD testing is a continuing challenge. A previously introduced decision support tool at UVA Health significantly reduced inappropriate testing without adverse outcomes. More recently, our methodology changed from nucleic acid amplification test (NAAT) alone to an initial NAAT followed by ELISA for toxin to improve specificity. The purpose of this analysis was to assess provider interpretation of test results, using targeted CD therapy as a surrogate. Methods This single-center, retrospective study evaluated all patients with a positive NAAT (Cepheid Xpert® C. difficile) on day 4 or later of hospitalization following 2-step algorithm implementation from Feb 2020 through Feb 2021. Toxin negative (TOX-) test results (C. DIFF QUIK CHEK COMPLETE®) were accompanied by a comment that discordance may represent colonization or CDI and to consider ID consult. The proportion of toxin positive (TOX+) versus TOX- patients receiving ≥ 1 dose of CD therapy served as the primary outcome with partial courses considered &lt; 10 days. Clinical outcomes were also compared. Results Ninety patients with NAAT+ results were included, of whom 58 (64%) were TOX-. Thirty-two (100%) TOX+ (median days of therapy [IQR] = 14 [11-17]) versus 51 (88%) TOX- patients (median days of therapy [IQR] = 11 [7-14]) received CD therapy (p=0.04). Treatment decisions were guided by ID physicians for 32 (63%) TOX- patients; ID recommendations to discontinue CD therapy were followed in 2 out of 9 (22%) cases. TOX- patients received partial therapy due to patient death (n=5), presumptive colonization (n=3), and provider error (n=1). Of TOX- patients receiving partial or no treatment, there were no CDI-related adverse outcomes during the admission. CDI-related colectomy occurred in 2 (6%) and 1 (2%) TOX+ and TOX- patients, respectively. Five in-hospital deaths with CDI as a contributing factor occurred in the TOX+ group. Conclusion Adoption of a 2-step NAAT plus toxin testing algorithm for hospital-onset CDI reduced the frequency with which TOX- patients received CD therapy but the vast majority were still treated. Most providers considered a positive NAAT indicative of CDI, regardless of TOX status. Disclosures All Authors: No reported disclosures

scholarly journals 756. Clostridioides difficile Burden of Disease: A Prospective Population-Based Surveillance Study of Hospitalized Adults in Louisville, Kentucky

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S475-S476
Author(s):  
Stephen Furmanek ◽  
Ruth Carrico ◽  
Fredrick J Angulo ◽  
Joann Zamparo ◽  
Elisa Gonzalez ◽  
...  
Keyword(s):  
Laboratory Testing ◽  
Eligible Patient ◽  
The United States ◽  
Population Based ◽  
Surveillance Study ◽  
Clostridioides Difficile ◽  
Stool Samples ◽  
Stool Specimens ◽  
New Onset ◽  
Research Grant

Abstract Background Clostridioides difficile (C. difficile) is an important cause of morbidity and mortality. C. difficile infection (CDI) may be frequently under-diagnosed because laboratory confirmation requires collection of a stool specimen from a patient with diarrhea and appropriate laboratory testing. Methods A prospective population-based CDI surveillance study was launched in 8 adult hospitals in Louisville, Kentucky on September 16, 2019. Surveillance officers in each hospital identified all cases of new-onset diarrhea (≥3 loose stools in the past but not preceding 24 hours) in Louisville residents ≥50 years of age. After informed consent, stool samples were collected and tested at the University of Louisville reference laboratory for 1) glutamate dehydrogenase (GDH) and 2) Clostridioides difficile toxins A and B using C. DIFF QUIK CHEK COMPLETE®, Techlab. We defined CDI as GDH positive and toxin positive. The study was paused on April 3, 2020, due to COVID-19 restrictions. Results There were 85,719 eligible patient-days during the study period. A total of 1541 patients had new-onset diarrhea corresponding to 1.8 cases of new-onset diarrhea per 100 eligible patient-days. We enrolled 84% (1291/1541) of patients with new-onset diarrhea and tested stool samples for C. difficile from 82% (1055/1291) for a testing density of 123 per 10,000 patient-days. Of the 1055 tested stool specimens, 73 (7%) were GDH positive and toxin positive (Figure 1) yielding a hospital-based CDI incidence of 8.5 CDI cases per 10,000 patient-days. Figure 1. Patient Ascertainment Flow Chart Conclusion New-onset diarrhea was common among hospitalized adults ≥50 years of age. CDI was frequently identified through stool specimens collected from eligible inpatients with new-onset diarrhea. Further analysis of these data and additional laboratory testing will contribute to a better understanding of the frequency of CDI underdiagnosis and the burden of CDI in the United States. Disclosures Ruth Carrico, PhD, DNP, APR, CIC, Pfizer (Consultant, Research Grant or Support, Speaker's Bureau)Sanofi Pasteur (Consultant, Grant/Research Support, Speaker's Bureau) Fredrick J. Angulo, DVM, PhD, Pfizer, Inc. (Employee) Joann Zamparo, MPH, Pfizer, Inc. (Employee) Elisa Gonzalez, MS, Pfizer, Inc. (Employee) Kimbal D. Ford, PharmD, Pfizer, Inc. (Employee) Julio Ramirez, M.D., FACP, Pfizer, Inc. (Scientific Research Study Investigator, Research Grant or Support, Speaker's Bureau)

scholarly journals GRADING prognostic factors for severe and recurrent Clostridioides difficile infection: expected and unexpected findings. A systematic review.

2021 ◽  
Author(s):  
Tessel Meike van Rossen ◽  
Rogier E. Ooijevaar ◽  
Christina M.J.E. Vandenbroucke-Grauls ◽  
Olaf M. Dekkers ◽  
Ed J. Kuijper ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Prognostic Factors ◽  
Laboratory Data ◽  
Final Analysis ◽  
Cochrane Library ◽  
Case Control Studies ◽  
Clostridioides Difficile ◽  
Increased Risk ◽  
Clostridioides Difficile Infection

Background Clostridioides difficile infection (CDI), its subsequent recurrences (rCDI), and severe CDI (sCDI) provide a significant burden for both patients and the healthcare system. Treatment consists of oral antibiotics. Fidaxomicin, bezlotoxumab and fecal microbiota transplantion (FMT) reduce the number of recurrences compared to vancomycin, but are more costly. Identifying patients diagnosed with initial CDI who are at increased risk of developing sCDI/rCDI could lead to more cost-effective therapeutic choices. Objectives In this systematic review we aimed to identify clinical prognostic factors associated with an increased risk of developing sCDI or rCDI. Methods PubMed, Embase, Emcare, Web of Science and COCHRANE Library databases were searched from database inception through March, 2021. Study selection was performed by two independent reviewers on the basis of predefined selection criteria; conflicts were resolved by consensus. Cohort and case-control studies providing an analysis of clinical or laboratory data to predict sCDI/rCDI in patients ≥18 years diagnosed with CDI, were included. Risk of bias was assessed with the Quality in Prognostic Research (QUIPS) tool and the quality of evidence by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool, modified for prognostic studies. Overview tables of prognostic factors were constructed to assess the number of studies and the respective direction of an association (positive, negative, or no association). Results and conclusions 136 studies were included for final analysis. Higher age and the presence of multiple comorbidities were prognostic factors for sCDI. Identified risk factors for rCDI were higher age, healthcare-associated CDI, prior hospitalization, PPIs started during/after CDI diagnosis and previous rCDI. Some variables that were found as risk factors for sCDI/rCDI in previous reviews were not confirmed in the current review, which can be attributed to differences in methodology. Risk stratification for sCDI/rCDI may contribute to a more personalized and optimal treatment for patients with CDI.

scholarly journals Effectiveness of a Two-Step Testing Algorithm for Reliable and Cost-Effective Detection of Clostridium difficile Infection in a Tertiary Care Hospital in Saudi Arabia

2019 ◽  
Vol 7 (1) ◽  
pp. 6
Author(s):  
Mohammed Qutub ◽  
Prasanth Govindan ◽  
Anupama Vattappillil
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Tertiary Care ◽  
Care Hospital ◽  
Predictive Values ◽  
Stool Samples ◽  
Step Algorithm ◽  
Testing Algorithm ◽  
Sensitivity Specificity ◽  
Pcr Test

The aim of this study was to evaluate the effectiveness of a two-step algorithm for the detection of Clostridium difficile infection. Setting and Design: A two-step testing algorithm was evaluated for testing stool samples from patients suspected of Clostridium difficile infection (CDI). A total of 103 stool specimens were tested using the C. diff Quik Chek Complete enzyme immunoassay (EIA) test and the Xpert C. difficile PCR test. A two-step algorithm was implemented, and data from 3518 patient samples tested during a two-year period after implementation were analyzed to evaluate the effectiveness. The sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of the Quik Chek Complete EIA test were calculated using the Xpert C. difficile PCR test as a reference method. The sensitivity, specificity, PPV, and NPV of the Quik Chek Complete EIA test for C. difficile toxin were 46.7%, 100%, 100%, and 91%, respectively. The two-step algorithm, which combined the Quik Chek Complete EIA with Xpert C. difficile PCR, improved the sensitivity and also provided rapid detection. When algorithm-based testing was performed daily, there was a 66% reduction in turnaround time compared to batch testing using a lengthy ELISA procedure. Postimplementation data analysis showed that almost 89% of the samples could be reported immediately by initial screening with Quik Chek Complete EIA. Only 11% of the samples gave discrepant results and required PCR confirmation. According to our results, the two-step algorithm is an effective tool for the rapid and reliable detection of toxigenic C. difficile from stool samples.

Analysis of judicial precedent cases regarding epidural injection in chronic pain management in Republic of Korea

2020 ◽  
Vol 45 (5) ◽  
pp. 337-343 ◽  
Author(s):  
Soo Ick Cho ◽  
SuHwan Shin ◽  
Haesun Jung ◽  
Jee Youn Moon ◽  
Ho-Jin Lee
Keyword(s):  
Medical Malpractice ◽  
Clinical Characteristics ◽  
Final Analysis ◽  
Epidural Injection ◽  
Adverse Outcomes ◽  
Chronic Pain Management ◽  
Common Complication ◽  
Epidural Injections ◽  
The Supreme Court ◽  
Low Incidence

BackgroundAlthough there is a low incidence of complications associated with epidural injections, pain physicians should still remain vigilant for potentially serious adverse outcomes. This study aimed to identify and describe the major complications of epidural injections.MethodsThis retrospective, observational, medicolegal study analyzed closed cases of precedents involving complications of epidural injections from January 1997 to August 2019 using the database of the Supreme Court of Korea’s judgement system. Clinical characteristics and judgement statuses were analyzed.ResultsOf the 73 potential cases assessed for eligibility, a total of 49 malpractice cases were included in the final analysis. Thirty-three claims resulted in payments to the plaintiffs, with a median payment of US$103 828 (IQR: US$45 291–US$265 341). The most common complication was infection (n=13, 26.5%), followed by worsening pain (n=8, 16.3%). Physician malpractice before, during, and after the procedure was claimed by plaintiffs in 18 (36.7%), 44 (89.8%), and 31 (63.3%) cases, respectively. Of these cases, 6 (33.3%), 19 (43.2%), and 15 (48.4%), respectively, were adjudicated in favor of the plaintiffs by the courts. In cases involving postprocedural physician errors, the majority (13/15) of the plaintiff verdicts were related to delayed management. Violation of the physician’s duty of informed consent was claimed by plaintiffs in 31 (63.3%) cases, and 14 (45.2%) of these cases were judged medical malpractice.ConclusionsOur data will allow pain physicians to become acquainted with the major epidural injection-associated complications that underlie malpractice cases.

Sequential introduction of a multistep testing algorithm and nucleic acid amplification testing leading to an increase in Clostridioides difficile detection and a trend toward increased strain diversity

2020 ◽  
Vol 41 (10) ◽  
pp. 1148-1153
Author(s):  
Andrew M. Skinner ◽  
Brian Yu ◽  
Adam Cheknis ◽  
Susan M. Pacheco ◽  
Dale N. Gerding ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Restriction Endonuclease Analysis ◽  
Nucleic Acid Amplification ◽  
Toxin Concentration ◽  
Detection Rates ◽  
Strain Diversity ◽  
Clostridioides Difficile ◽  
Nucleic Acid Amplification Testing ◽  
Testing Algorithm

AbstractBackground:Most clinical microbiology laboratories have replaced toxin immunoassay (EIA) alone with multistep testing (MST) protocols or nucleic acid amplification testing (NAAT) alone for the detection of C. difficile.Objective:Study the effect of changing testing strategies on C. difficile detection and strain diversity.Design:Retrospective study.Setting:A Veterans’ Affairs hospital.Methods:Initially, toxin EIA testing was replaced by an MST approach utilizing a glutamate dehydrogenase (GDH) and toxin EIA followed by tcdB NAAT for discordant results. After 18 months, MST was replaced by a NAAT-only strategy. Available patient stool specimens were cultured for C. difficile. Restriction endonuclease analysis (REA) strain typing and quantitative in vitro toxin testing were performed on recovered isolates.Results:Before MST (toxin EIA), 79 of 708 specimens (11%) were positive, and after MST (MST-A), 121 of 517 specimens (23%) were positive (P < .0001). Prior to NAAT-only testing (MST-B), 80 of the 490 specimens (16%) were positive by MST, and after NAAT-only testing was implemented, 67 of the 368 specimens (18%) were positive (P = nonsignificant). After replacing toxin EIA testing, REA strain group diversity increased (8, 13, 13, and 10 REA groups in the toxin EIA, MST-A, MST-B, and NAAT-only periods, respectively) and in vitro toxin concentration decreased. The average log10 toxin concentration of the isolates were 2.08, 1.88, 1.20 and 1.55 ng/mL for the same periods, respectively.Conclusions:MST and NAAT had similar detection rates for C. difficile. Compared to toxin testing alone, they detected increased diversity of C. difficile strains, many of which were low toxin producing.

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