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  • 1
    In: Pharmacoepidemiology and Drug Safety, Wiley, Vol. 29, No. 4 ( 2020-04), p. 419-426
    Kurzfassung: The Medicaid Analytic eXtract (MAX) is a health care utilization database from publicly insured individuals that has been used for studies of drug safety in pregnancy. Claims‐based algorithms for defining many important maternal and neonatal outcomes have not been validated. Objective To validate claims‐based algorithms for identifying selected pregnancy outcomes in MAX using hospital medical records. Methods The medical records of mothers who delivered between 2000 and 2010 within a single large healthcare system were linked to their claims in MAX. Claims‐based algorithms for placental abruption, preeclampsia, postpartum hemorrhage, small for gestational age, and noncardiac congenital malformation were defined. Fifty randomly sampled cases for each outcome identified using these algorithms were selected, and their medical records were independently reviewed by two physicians to confirm the presence of the diagnosis of interest; disagreements were resolved by a third physician reviewer. Positive predictive values (PPVs) and 95% confidence intervals (CIs) of the claims‐based algorithms were calculated using medical records as the gold standard. Results The linked cohort included 10,899 live‐birth pregnancies. The PPV was 92% (95% CI, 82%‐97%) for placental abruption, 82% (95% CI, 70%‐91%) for preeclampsia, 74% (95% CI, 61%‐85%) for postpartum hemorrhage, 92% (95% CI, 82%‐97%) for small for gestational age, and 86% (95% CI, 74%‐94%) for noncardiac congenital malformation. Conclusions Across the perinatal outcomes considered, PPVs ranged between 74% and 92%. These PPVs can inform bias analyses that correct for outcome misclassification.
    Materialart: Online-Ressource
    ISSN: 1053-8569 , 1099-1557
    URL: Issue
    Sprache: Englisch
    Verlag: Wiley
    Publikationsdatum: 2020
    ZDB Id: 1491218-1
    SSG: 15,3
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 2
    In: Pharmacoepidemiology and Drug Safety, Wiley, Vol. 32, No. 4 ( 2023-04), p. 468-474
    Kurzfassung: Perinatal epidemiology studies using healthcare utilization databases are often restricted to live births, largely due to the lack of established algorithms to identify non‐live births. The study objective was to develop and validate claims‐based algorithms for the ascertainment of non‐live births. Methods Using the Mass General Brigham Research Patient Data Registry 2000–2014, we assembled a cohort of women enrolled in Medicaid with a non‐live birth. Based on ≥1 inpatient or ≥2 outpatient diagnosis/procedure codes, we identified and randomly sampled 100 potential stillbirth, spontaneous abortion, and termination cases each. For the secondary definitions, we excluded cases with codes for other pregnancy outcomes within ±5 days of the outcome of interest and relaxed the definitions for spontaneous abortion and termination by allowing cases with one outpatient diagnosis only. Cases were adjudicated based on medical chart review. We estimated the positive predictive value (PPV) for each outcome. Results The PPV was 71.0% (95% CI, 61.1–79.6) for stillbirth; 79.0% (69.7–86.5) for spontaneous abortion, and 93.0% (86.1–97.1) for termination. When excluding cases with adjacent codes for other pregnancy outcomes and further relaxing the definition, the PPV increased to 80.6% (69.5–88.9) for stillbirth, 86.6% (80.5–91.3) for spontaneous abortion and 94.9% (91.1–97.4) for termination. The PPV for the composite outcome using the relaxed definition was 94.4% (92.3–96.1). Conclusions Our findings suggest non‐live birth outcomes can be identified in a valid manner in epidemiological studies based on healthcare utilization databases.
    Materialart: Online-Ressource
    ISSN: 1053-8569 , 1099-1557
    URL: Issue
    Sprache: Englisch
    Verlag: Wiley
    Publikationsdatum: 2023
    ZDB Id: 1491218-1
    SSG: 15,3
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 3
    In: BMJ, BMJ
    Kurzfassung: To evaluate the risk of first trimester exposure to prescription opioids for major congenital malformations, previously reported to be associated with such exposure. Design Population based cohort study. Setting Nationwide sample of publicly and commercially insured pregnant women linked to their liveborn infants, nested in the Medicaid Analytic eXtract (MAX, 2000-14) and the MarketScan Research Database (MarketScan, 2003-15). Participants 1 602 580 publicly insured (MAX) and 1 177 676 commercially insured (MarketScan) pregnant women with eligibility from at least three months before pregnancy to one month after delivery; infants with eligibility for at least three months after birth. Interventions Use of prescription opioids was ascertained by requiring two or more dispensations of any opioid during the first trimester. Main outcomes measures Major malformations overall, cardiac malformations overall, ventricular septal defect, secundum atrial septal defect/patent foramen ovale, neural tube defect, clubfoot, and oral cleft, defined based on validated algorithms. Propensity score stratification was used to adjust for potential confounders and/or proxies for confounders. Estimates from each database were combined using meta-analysis. Results 70 447 (4.4%) of 1 602 580 publicly insured and 12 454 (1.1%) of 1 177 676 commercially insured pregnant women had two or more dispensations of an opioid during the first trimester. Absolute risk of malformations overall was 41.0 (95% confidence interval 39.5 to 42.5) per 1000 pregnancies exposed to opioids versus 32.0 (31.7 to 32.3) per 1000 unexposed pregnancies in the MAX cohort, and 42.6 (39.0 to 46.1) and 37.3 (37.0 to 37.7) per 1000, respectively, in the MarketScan cohort. Pooled unadjusted relative risk estimates were raised for all outcomes but shifted substantially toward the null after adjustment; for malformations overall (relative risk 1.06, 95% confidence interval 1.02 to 1.10), cardiovascular malformations (1.09, 1.00 to 1.18), ventricular septal defect (1.07, 0.95 to 1.21), atrial septal defect/patent foramen ovale (1.04, 0.88 to 1.24), neural tube defect (0.82, 0.53 to 1.27), and clubfoot (1.06, 0.88 to 1.28). The relative risk for oral clefts remained raised after adjustment (1.21, 0.98 to 1.50), with a higher risk of cleft palate (1.62, 1.23 to 2.14). Conclusions Prescription opioids used in early pregnancy are not associated with a substantial increase in risk for most of the malformation types considered, although a small increase in the risk of oral clefts associated with their use is possible.
    Materialart: Online-Ressource
    ISSN: 1756-1833
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2021
    ZDB Id: 1479799-9
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 4
    In: BMJ, BMJ
    Kurzfassung: To examine the risk of congenital malformations associated with exposure to oral fluconazole at commonly used doses in the first trimester of pregnancy for the treatment of vulvovaginal candidiasis. Design Population based cohort study. Setting A cohort of pregnancies publicly insured in the United States, with data from the nationwide Medicaid Analytic eXtract 2000-14. Participants Pregnancies of women enrolled in Medicaid from three or more months before the last menstrual period to one month after delivery, and infants enrolled for three or more months after birth. Interventions Use of fluconazole and topical azoles was established by requiring one or more prescriptions during the first trimester of pregnancy. Main outcome measures Risk of musculoskeletal malformations, conotruncal malformations, and oral clefts (primary outcomes), associated with exposure to oral fluconazole, diagnosed during the first 90 days after delivery, were examined. Results The study cohort of 1 969 954 pregnancies included 37 650 (1.9%) pregnancies exposed to oral fluconazole and 82 090 (4.2%) pregnancies exposed to topical azoles during the first trimester. The risk of musculoskeletal malformations was 52.1 (95% confidence interval 44.8 to 59.3) per 10 000 pregnancies exposed to fluconazole versus 37.3 (33.1 to 41.4) per 10 000 pregnancies exposed to topical azoles. The risks of conotruncal malformations were 9.6 (6.4 to 12.7) versus 8.3 (6.3 to 10.3) per 10 000 pregnancies exposed to fluconazole and topical azoles, respectively; risks of oral clefts were 9.3 (6.2 to 12.4) versus 10.6 (8.4 to 12.8) per 10 000 pregnancies, respectively. The adjusted relative risk after fine stratification of the propensity score was 1.30 (1.09 to 1.56) for musculoskeletal malformations, 1.04 (0.70 to 1.55) for conotruncal malformations, and 0.91 (0.61 to 1.35) for oral clefts overall. Based on cumulative doses of fluconazole, the adjusted relative risks for musculoskeletal malformations, conotruncal malformations, and oral clefts overall were 1.29 (1.05 to 1.58), 1.12 (0.71 to 1.77), and 0.88 (0.55 to 1.40) for 150 mg of fluconazole; 1.24 (0.93 to 1.66), 0.61 (0.26 to 1.39), and 1.08 (0.58 to 2.04) for more than 150 mg up to 450 mg of fluconazole; and 1.98 (1.23 to 3.17), 2.30 (0.93 to 5.65), and 0.94 (0.23 to 3.82) for more than 450 mg of fluconazole, respectively. Conclusions Oral fluconazole use in the first trimester was not associated with oral clefts or conotruncal malformations, but an association with musculoskeletal malformations was found, corresponding to a small adjusted risk difference of about 12 incidents per 10 000 exposed pregnancies overall.
    Materialart: Online-Ressource
    ISSN: 1756-1833
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2020
    ZDB Id: 1479799-9
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 5
    Online-Ressource
    Online-Ressource
    American Medical Association (AMA) ; 2020
    In:  JAMA Vol. 323, No. 4 ( 2020-01-28), p. 372-
    In: JAMA, American Medical Association (AMA), Vol. 323, No. 4 ( 2020-01-28), p. 372-
    Materialart: Online-Ressource
    ISSN: 0098-7484
    RVK:
    Sprache: Englisch
    Verlag: American Medical Association (AMA)
    Publikationsdatum: 2020
    ZDB Id: 2958-0
    ZDB Id: 2018410-4
    SSG: 5,21
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 6
    In: JAMA Internal Medicine, American Medical Association (AMA), Vol. 182, No. 5 ( 2022-05-01), p. 522-
    Materialart: Online-Ressource
    ISSN: 2168-6106
    Sprache: Englisch
    Verlag: American Medical Association (AMA)
    Publikationsdatum: 2022
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 7
    In: JAMA Internal Medicine, American Medical Association (AMA), Vol. 182, No. 11 ( 2022-11-01), p. 1149-
    Kurzfassung: Antidepressant use during pregnancy has been associated with neurodevelopmental disorders in children in some studies. However, results may be explained by uncontrolled confounding by parental mental health status, genetics, and environmental factors. Objective To evaluate the association between antidepressant use in pregnancy and neurodevelopmental outcomes in children. Design, Setting, and Participants This cohort study of health care utilization data was separated into cohorts of publicly and privately insured pregnant individuals and their children nested in the Medicaid Analytic eXtract (MAX; 2000-2014) and the IBM MarketScan Research Database (MarketScan; 2003-2015). A total of 1.93 million pregnancies in MAX and 1.25 million pregnancies in MarketScan were recorded. Children were followed from birth until outcome diagnosis, disenrollment, death, or end of study (maximum 14 years). Analyses were conducted between August 2020 and July 2021. Exposures Dispensing of antidepressant medication from gestational week 19 until delivery, the period of synaptogenesis. Main Outcomes and Measures Neurodevelopmental disorders in children defined using validated algorithms. Early pregnancy exposure was considered in sensitivity analyses, and approaches to confounding adjustment included propensity score fine stratification, discontinuers comparison, and sibling analyses. Results Among the individuals included in the analysis, there were 145 702 antidepressant-exposed and 3 032 745 unexposed pregnancies; the mean (SD) age among the antidepressant exposed and unexposed was 26.2 (5.7) and 24.3 (5.8) years in MAX and 32.7 (4.6) and 31.9 (4.6) years in MarketScan, respectively; and in MAX, which collected information on race and ethnicity, 72.4% of the antidepressant-exposed and 37.1% of the unexposed individuals were White. Crude results suggested up to a doubling in risk of neurodevelopmental outcomes associated with antidepressant exposure; however, no association was observed in the most fully adjusted analyses. When comparing antidepressant-exposed and unexposed siblings, hazard ratios were 0.97 (95% CI, 0.88-1.06) for any neurodevelopmental disorder, 0.86 (95% CI, 0.60-1.23) for autism spectrum disorder, 0.94 (95% CI, 0.81-1.08) for attention-deficit/hyperactivity disorder, 0.77 (95% CI, 0.42-1.39) for specific learning disorders, 1.01 (95% CI, 0.88-1.16) for developmental speech/language disorder, 0.79 (95% CI, 0.54-1.17) for developmental coordination disorder, 1.00 (95% CI, 0.45-2.22) for intellectual disability, and 0.95 (95% CI, 0.80-1.12) for behavioral disorders. Results were generally consistent for antidepressant classes and drugs and across exposure windows. Conclusions and Relevance The results of this cohort study suggest that antidepressant use in pregnancy itself does not increase the risk of neurodevelopmental disorders in children. However, given strong crude associations, antidepressant exposure in pregnancy may be an important marker for the need of early screening and intervention.
    Materialart: Online-Ressource
    ISSN: 2168-6106
    Sprache: Englisch
    Verlag: American Medical Association (AMA)
    Publikationsdatum: 2022
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 8
    In: New England Journal of Medicine, Massachusetts Medical Society, Vol. 387, No. 22 ( 2022-12-01), p. 2033-2044
    Materialart: Online-Ressource
    ISSN: 0028-4793 , 1533-4406
    RVK:
    Sprache: Englisch
    Verlag: Massachusetts Medical Society
    Publikationsdatum: 2022
    ZDB Id: 1468837-2
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 9
    In: JAMA, American Medical Association (AMA), Vol. 320, No. 23 ( 2018-12-18), p. 2429-
    Materialart: Online-Ressource
    ISSN: 0098-7484
    RVK:
    Sprache: Englisch
    Verlag: American Medical Association (AMA)
    Publikationsdatum: 2018
    ZDB Id: 2958-0
    ZDB Id: 2018410-4
    SSG: 5,21
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 10
    In: Pharmacoepidemiology and Drug Safety, Wiley, Vol. 30, No. 12 ( 2021-12), p. 1635-1642
    Kurzfassung: To validate healthcare claim‐based algorithms for neurodevelopmental disorders (NDD) in children using medical records as the reference. Methods Using a clinical data warehouse of patients receiving outpatient or inpatient care at two hospitals in Boston, we identified children (≤14 years between 2010 and 2014) with at least one of the following NDDs according to claims‐based algorithms: autism spectrum disorder/pervasive developmental disorder (ASD), attention deficit disorder/other hyperkinetic syndromes of childhood (ADHD), learning disability, speech/language disorder, developmental coordination disorder (DCD), intellectual disability, and behavioral disorder. Fifty cases per outcome were randomly sampled and their medical records were independently reviewed by two physicians to adjudicate the outcome presence. Positive predictive values (PPVs) and 95% confidence intervals (CIs) were calculated. Results PPVs were 94% (95% CI, 83%–99%) for ASD, 88% (76%–95%) for ADHD, 98% (89%–100%) for learning disability, 98% (89%–100%) for speech/language disorder, 82% (69%–91%) for intellectual disability, and 92% (81%–98%) for behavioral disorder. A total of 19 of the 50 algorithm‐based cases of DCD were confirmed as severe coordination disorders with functional impairment, with a PPV of 38% (25%–53%). Among the 31 false‐positive cases of DCD were 7 children with coordination deficits that did not persist throughout childhood, 7 with visual‐motor integration deficits, 12 with coordination issues due to an underlying medical condition and 5 with ADHD and at least one other severe NDD. Conclusions PPVs were generally high (range: 82%–98%), suggesting that claims‐based algorithms can be used to study NDDs. For DCD, additional criteria are needed to improve the classification of true cases.
    Materialart: Online-Ressource
    ISSN: 1053-8569 , 1099-1557
    URL: Issue
    Sprache: Englisch
    Verlag: Wiley
    Publikationsdatum: 2021
    ZDB Id: 1491218-1
    SSG: 15,3
    Standort Signatur Einschränkungen Verfügbarkeit
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