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  • 1
    Online Resource
    Online Resource
    Understanding Variation in Rotavirus Vaccine Effectiveness Estimates in the United States: The Role of Rotavirus Activity and Diagnostic Misclassification
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Epidemiology Vol. 33, No. 5 ( 2022-09), p. 660-668
    Details
    In: Epidemiology, Ovid Technologies (Wolters Kluwer Health), Vol. 33, No. 5 ( 2022-09), p. 660-668
    Abstract: Estimates of rotavirus vaccine effectiveness (VE) in the United States appear higher in years with more rotavirus activity. We hypothesized rotavirus VE is constant over time but appears to vary as a function of temporal variation in local rotavirus cases and/or misclassified diagnoses. Methods: We analyzed 6 years of data from eight US surveillance sites on 8- to 59-month olds with acute gastroenteritis symptoms. Children’s stool samples were tested via enzyme immunoassay (EIA); rotavirus-positive results were confirmed with molecular testing at the US Centers for Disease Control and Prevention. We defined rotavirus gastroenteritis cases by either positive on-site EIA results alone or positive EIA with Centers for Disease Control and Prevention confirmation. For each case definition, we estimated VE against any rotavirus gastroenteritis, moderate-to-severe disease, and hospitalization using two mixed-effect regression models: the first including year plus a year–vaccination interaction, and the second including the annual percent of rotavirus-positive tests plus a percent positive–vaccination interaction. We used multiple overimputation to bias-adjust for misclassification of cases defined by positive EIA alone. Results: Estimates of annual rotavirus VE against all outcomes fluctuated temporally, particularly when we defined cases by on-site EIA alone and used a year–vaccination interaction. Use of confirmatory testing to define cases reduced, but did not eliminate, fluctuations. Temporal fluctuations in VE estimates further attenuated when we used a percent positive–vaccination interaction. Fluctuations persisted until bias-adjustment for diagnostic misclassification. Conclusions: Both controlling for time-varying rotavirus activity and bias-adjusting for diagnostic misclassification are critical for estimating the most valid annual rotavirus VE.
    Type of Medium: Online Resource
    ISSN: 1044-3983
    URL: Article
    DOI: 10.1097/EDE.0000000000001501
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
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  • 2
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    Detection of Clostridioides difficile by Real-time PCR in Young Children Does Not Predict Disease
    American Academy of Pediatrics (AAP) ; 2020
    In:  Hospital Pediatrics Vol. 10, No. 7 ( 2020-07-01), p. 555-562
    Details
    In: Hospital Pediatrics, American Academy of Pediatrics (AAP), Vol. 10, No. 7 ( 2020-07-01), p. 555-562
    Abstract: Diagnosing Clostridioides difficile infections in young children with high asymptomatic colonization is challenging. We compared the frequency of C difficile detection by polymerase chain reaction (PCR) in healthy control (HC) children with those with acute gastroenteritis (AGE) and evaluated fecal-lactoferrin and organism load as possible indicators of true C difficile infection disease. METHODS: Stool was collected from children & lt;2 years old with AGE and from HCs. C difficile was detected by real-time PCR, and lactoferrin was measured by enzyme-linked immunosorbent assay. Clinical data were obtained via interviews and chart review. Mann–Whitney U test and χ2 tests were used for group comparisons. RESULTS: Of 524 stools collected from 524 children (250 with AGE, 274 HCs), C difficile was detected less in children with AGE (14%, 36 of 250) than in HCs (28%, 76 of 274) stools (P & lt; .0001). Among infants & lt;1 year old (n = 297), C difficile was detected in 18% of children with AGE versus 32% of HCs (P & lt; .005), and among children 1 to 2 years old (n = 227), C difficile was detected in 10% of children with AGE versus 21% of HCs (P & lt; .02). There was no significant difference in C difficile PCR cycle threshold values between children with AGE and HCs or lactoferrin levels in C difficile PCR-positive versus -negative stools. CONCLUSIONS: HC children & lt;2 years of age had higher rates of C difficile detection by PCR than children with AGE; C difficile detection by real-time PCR alone is not a reliable means to diagnose C difficile disease in children & lt;2 years old.
    Type of Medium: Online Resource
    ISSN: 2154-1663 , 2154-1671
    URL: Article
    DOI: 10.1542/hpeds.2020-0012
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2020
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