1b79f2ddae5047915af8ed6dcb761ebd pmc_9144429.pdf bdf1356eaa694b0e3d8f21c69340dfacb9ff856e pmc_9144429.pdf be508b324860bda81dc4cd33f4aacb4d3b4c03b6192f25b39509960306f6925c pmc_9144429.pdf Title: Impact of the Introduction of a Two-Step Laboratory Diagnostic Algorithm in the Incidence and Earlier Diagnosis of Clostridioides difficile Infection Subject: Our aim was to determine changes in the incidence of CD infection (CDI) following the introduction of a two-step diagnostic algorithm and to analyze CDI cases diagnosed in the study period. We retrospectively studied CDI (January 2009 to July 2018) in adults diagnosed by toxin enzyme immunoassay (EIA) (2009–2012) or toxin-EIA + polymerase chain reaction (PCR) algorithm (2013 onwards). A total of 443 patients with a first episode of CDI were included, 297 (67.1%) toxin-EIA-positive and 146 (32.9%) toxin-EIA-negative/PCR-positive were only identified through the two-step algorithm including the PCR test. The incidence of CDI increased from 0.9 to 4.7/10,000 patient-days (p < 0.01) and 146 (32.9%) toxin-negative CDI were diagnosed. Testing rate increased from 24.4 to 59.5/10,000 patient-days (p < 0.01) and the percentage of positive stools rose from 3.9% to 12.5% (p < 0.01). CD toxin-positive patients had a higher frequency of severe presentation and a lower rate of immunosuppressive drugs and inflammatory bowel disease. Mortality (16.3%) was significantly higher in patients with hematological neoplasm, intensive care unit admission and complicated disease. Recurrences (14.9%) were significantly higher with proton pump inhibitor exposure. The two-step diagnostic algorithm facilitates earlier diagnosis, potentially impacting patient outcomes and nosocomial spread. CD-toxin-positive patients had a more severe clinical presentation, probably due to increased CD bacterial load with higher toxin concentration. This early and easy marker should alert clinicians of potentially more severe outcomes. Keywords: Clostridioides difficile; Clostridioides difficile toxin; infection control and prevention;healthcare-associated infection; immunosuppressed patients Author: Nieves Sopena, Jun Hao Wang-Wang, Irma Casas, Lourdes Mateu, Laia Castellà, María José García-Quesada, Sara Gutierrez, Josep M. Llibre, M. Luisa Pedro-Botet and Gema Fernandez-Rivas Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Tue May 24 11:09:58 2022 CEST ModDate: Tue May 24 11:12:25 2022 CEST Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 12 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 673996 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- MWHIBA+VnURWPalladioL Type 1 Custom yes yes no 10 0 QMLPLX+URWPalladioL-Bold Type 1 Custom yes yes no 15 0 RZAIWD+URWPalladioL-Roma Type 1 Custom yes yes no 20 0 CXWULG+URWPalladioL-Ital Type 1 Custom yes yes no 24 0 EEYNML+URWPalladioL-BoldItal Type 1 Custom yes yes no 28 0 GGHKEL+VnURWPalladioL-Bold Type 1 Custom yes yes no 32 0 SIXRFS+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 50 0 GQWIGS+CMSY10 Type 1 Builtin yes yes no 72 0 BCDEEE+PalatinoLinotype-Bold TrueType WinAnsi yes yes no 87 0 BCDFEE+PalatinoLinotype-Roman TrueType WinAnsi yes yes no 91 0 BCDGEE+PalatinoLinotype-Italic TrueType WinAnsi yes yes no 95 0 BCDIEE+PalatinoLinotype-Roman CID TrueType Identity-H yes yes yes 99 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2023-09-28 02:34:58 CEST RepresentationInformation: pmc_9144429.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2023-09-27 02:17:53 CEST Size: 673996 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 276 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@262b2c86 Item: Title: Methods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@371a67ec Children: Item: Title: Study Design and Patients Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@5ed828d Item: Title: Patients Design Statement Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@50d0686 Item: Title: Statistical Analysis Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7a3d45bd Item: Title: Results Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1e7c7811 Children: Item: Title: CDI Incidence along the Time Periods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@77ec78b9 Item: Title: Characteristics of the Patients Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1a3869f4 Item: Title: CDI Treatment Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@a38d7a3 Item: Title: Clinical Outcomes Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@77f99a05 Item: Title: Discussion Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@63440df3 Item: Title: Conclusions Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@3aeaafa6 Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@76a3e297 Info: Title: Impact of the Introduction of a Two-Step Laboratory Diagnostic Algorithm in the Incidence and Earlier Diagnosis of Clostridioides difficile Infection Author: Nieves Sopena, Jun Hao Wang-Wang, Irma Casas, Lourdes Mateu, Laia Castellà, María José García-Quesada, Sara Gutierrez, Josep M. Llibre, M. Luisa Pedro-Botet and Gema Fernandez-Rivas Subject: Our aim was to determine changes in the incidence of CD infection (CDI) following the introduction of a two-step diagnostic algorithm and to analyze CDI cases diagnosed in the study period. We retrospectively studied CDI (January 2009 to July 2018) in adults diagnosed by toxin enzyme immunoassay (EIA) (2009 2012) or toxin-EIA + polymerase chain reaction (PCR) algorithm (2013 onwards). A total of 443 patients with a first episode of CDI were included, 297 (67.1%) toxin-EIA-positive and 146 (32.9%) toxin-EIA-negative/PCR-positive were only identified through the two-step algorithm including the PCR test. The incidence of CDI increased from 0.9 to 4.7/10,000 patient-days (p < 0.01) and 146 (32.9%) toxin-negative CDI were diagnosed. Testing rate increased from 24.4 to 59.5/10,000 patient-days (p < 0.01) and the percentage of positive stools rose from 3.9% to 12.5% (p < 0.01). CD toxin-positive patients had a higher frequency of severe presentation and a lower rate of immunosuppressive drugs and inflammatory bowel disease. Mortality (16.3%) was significantly higher in patients with hematological neoplasm, intensive care unit admission and complicated disease. Recurrences (14.9%) were significantly higher with proton pump inhibitor exposure. The two-step diagnostic algorithm facilitates earlier diagnosis, potentially impacting patient outcomes and nosocomial spread. CD-toxin-positive patients had a more severe clinical presentation, probably due to increased CD bacterial load with higher toxin concentration. This early and easy marker should alert clinicians of potentially more severe outcomes. 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