Browsing by Author "Gatz, Jennifer L."

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    Association Between Intrauterine Device Type and Risk of Perforation and Device Expulsion: Results From the APEX-IUD Study
    (ScienceDirect, 2022) Gatz, Jennifer L.; Armstrong, Mary Anne; Postlethwaite, Debbie; Raine-Bennett, Tina; Chillemi, Giulia; Alabaster, Amy; Merchant, Maqdooda; Reed, Susan D.; Ichikawa, Laura; Getahun, Darios; Fassett, Michael J.; Shi, Jiaxiao M.; Xie, Fagen; Chiu, Vicki Y.; Im, Theresa M.; Takhar, Harpreet S.; Wang, Jinyi; Saltus, Catherine W.; Ritchey, Mary E.; Asiimwe, Alex; Pisa, Federica; Schoendorf, Juliane; Wahdan, Yesmean; Zhou, Xiaolei; Hunter, Shannon; Anthony, Mary S.; Peipert, Jeffrey F.; Medicine, School of Medicine
    Background Intrauterine devices, including levonorgestrel-releasing and copper devices, are highly effective long-acting reversible contraceptives. The potential risks associated with intrauterine devices are low and include uterine perforation and device expulsion. Objective This study aimed to evaluate the risk of perforation and expulsion associated with levonorgestrel-releasing devices vs copper devices in clinical practice in the United States. Study Design The Association of Perforation and Expulsion of Intrauterine Devices study was a retrospective cohort study of women aged ≤50 years with an intrauterine device insertion during 2001 to 2018 and information on intrauterine device type and patient and medical characteristics. Of note, 4 research sites with access to electronic health records contributed data for the study: 3 Kaiser Permanente–integrated healthcare systems (Northern California, Southern California, and Washington) and 1 healthcare system using data from a healthcare information exchange in Indiana (Regenstrief Institute). Perforation was classified as any extension of the device into or through the myometrium. Expulsion was classified as complete (not visible in the uterus or abdomen or patient reported) or partial (any portion in the cervix or malpositioned). We estimated the crude incidence rates and crude cumulative incidence by intrauterine device type. The risks of perforation and expulsion associated with levonorgestrel-releasing intrauterine devices vs copper intrauterine devices were estimated using Cox proportional-hazards regression with propensity score overlap weighting to adjust for confounders. Results Among 322,898 women included in this analysis, the incidence rates of perforation per 1000 person-years were 1.64 (95% confidence interval, 1.53–1.76) for levonorgestrel-releasing intrauterine devices and 1.27 (95% confidence interval, 1.08–1.48) for copper intrauterine devices; 1-year and 5-year crude cumulative incidence was 0.22% (95% confidence interval, 0.20–0.24) and 0.63% (95% confidence interval, 0.57–0.68) for levonorgestrel-releasing intrauterine devices and 0.16% (95% confidence interval, 0.13–0.20) and 0.55% (95% confidence interval, 0.44–0.68) for copper intrauterine devices, respectively. The incidence rates of expulsion per 1000 person-years were 13.95 (95% confidence interval, 13.63–14.28) for levonorgestrel-releasing intrauterine devices and 14.08 (95% confidence interval, 13.44–14.75) for copper intrauterine devices; 1-year and 5-year crude cumulative incidence was 2.30% (95% confidence interval, 2.24–2.36) and 4.52% (95% confidence interval, 4.40–4.65) for levonorgestrel-releasing intrauterine devices and 2.30% (95% confidence interval, 2.18–2.44) and 4.82 (95% confidence interval, 4.56–5.10) for copper intrauterine devices, respectively. Comparing levonorgestrel-releasing intrauterine devices with copper intrauterine devices, the adjusted hazard ratios were 1.49 (95% confidence intervals, 1.25–1.78) for perforation and 0.69 (95% confidence intervals, 0.65–0.73) for expulsion. Conclusion After adjusting for potential confounders, levonorgestrel-releasing intrauterine devices were associated with an increased risk of uterine perforation and a decreased risk of expulsion relative to copper intrauterine devices. Given that the absolute numbers of these events are low in both groups, these differences may not be clinically meaningful.
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    Design of the Association of Uterine Perforation and Expulsion of Intrauterine Device study: a multisite retrospective cohort study
    (Elsevier, 2021) Anthony, Mary S.; Reed, Susan D.; Armstrong, Mary Anne; Getahun, Darios; Gatz, Jennifer L.; Saltus, Catherine W.; Zhou, Xiaolei; Schoendorf, Juliane; Postlethwaite, Debbie A.; Raine-Bennett, Tina; Fassett, Michael J.; Peipert, Jeffrey F.; Ritchey, Mary E.; Ichikawa, Laura E.; Lynen, Richard; Alabaster, Amy L.; Merchant, Maqdooda; Chiu, Vicki Y.; Shi, Jiaxiao M.; Xie, Fagen; Hui, Siu L.; Wang, Jinyi; Hunter, Shannon; Bartsch, Jennifer; Frenz, Ann-Kathrin; Chillemi, Giulia; Im, Theresa M.; Takhar, Harpreet S.; Asiimwe, Alex; Obstetrics and Gynecology, School of Medicine
    Background Intrauterine devices are effective and safe, long-acting reversible contraceptives, but the risk of uterine perforation occurs with an estimated incidence of 1 to 2 per 1000 insertions. The European Active Surveillance Study for Intrauterine Devices, a European prospective observational study that enrolled 61,448 participants (2006–2012), found that women breastfeeding at the time of device insertion or with the device inserted at ≤36 weeks after delivery had a higher risk of uterine perforation. The Association of Uterine Perforation and Expulsion of Intrauterine Device (APEX-IUD) study was a Food and Drug Administration–mandated study designed to reflect current United States clinical practice. The aims of the APEX-IUD study were to evaluate the risk of intrauterine device–related uterine perforation and device expulsion among women who were breastfeeding or within 12 months after delivery at insertion. Objective We aimed to describe the APEX-IUD study design, methodology, and analytical plan and present population characteristics, size of risk factor groups, and duration of follow-up. Study Design APEX-IUD study was a retrospective cohort study conducted in 4 organizations with access to electronic health records: Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and Regenstrief Institute in Indiana. Variables were identified through structured data (eg, diagnostic, procedural, medication codes) and unstructured data (eg, clinical notes) via natural language processing. Outcomes include uterine perforation and device expulsion; potential risk factors were breastfeeding at insertion, postpartum timing of insertion, device type, and menorrhagia diagnosis in the year before insertion. Covariates include demographic characteristics, clinical characteristics, and procedure-related variables, such as difficult insertion. The first potential date of inclusion for eligible women varies by research site (from January 1, 2001 to January 1, 2010). Follow-up begins at insertion and ends at first occurrence of an outcome of interest, a censoring event (device removal or reinsertion, pregnancy, hysterectomy, sterilization, device expiration, death, disenrollment, last clinical encounter), or end of the study period (June 30, 2018). Comparisons of levels of exposure variables were made using Cox regression models with confounding adjusted by propensity score weighting using overlap weights. Results The study population includes 326,658 women with at least 1 device insertion during the study period (Kaiser Permanente Northern California, 161,442; Kaiser Permanente Southern California, 123,214; Kaiser Permanente Washington, 20,526; Regenstrief Institute, 21,476). The median duration of continuous enrollment was 90 (site medians 74–177) months. The mean age was 32 years, and the population was racially and ethnically diverse across the 4 sites. The mean body mass index was 28.5 kg/m2, and of the women included in the study, 10.0% had menorrhagia ≤12 months before insertion, 5.3% had uterine fibroids, and 10% were recent smokers; furthermore, among these women, 79.4% had levonorgestrel-releasing devices, and 19.5% had copper devices. Across sites, 97,824 women had an intrauterine device insertion at ≤52 weeks after delivery, of which 94,817 women (97%) had breastfeeding status at insertion determined; in addition, 228,834 women had intrauterine device insertion at >52 weeks after delivery or no evidence of a delivery in their health record. Conclusion Combining retrospective data from multiple sites allowed for a large and diverse study population. Collaboration with clinicians in the study design and validation of outcomes ensured that the APEX-IUD study results reflect current United States clinical practice. Results from this study will provide valuable information based on real-world evidence about risk factors for intrauterine devices perforation and expulsion for clinicians.
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    Real-world performance of SARS-Cov-2 serology tests in the United States, 2020
    (Public Library of Science, 2023-02-03) Rodriguez-Watson, Carla V.; Louder, Anthony M.; Kabelac, Carly; Frederick, Christopher M.; Sheils, Natalie E.; Eldridge, Elizabeth H.; Lin, Nancy D.; Pollock, Benjamin D.; Gatz, Jennifer L.; Grannis, Shaun J.; Vashisht, Rohit; Ghauri, Kanwal; Knepper, Camille; Leonard, Sandy; Embi, Peter J.; Jenkinson, Garrett; Klesh, Reyna; Garner, Omai B.; Patel, Ayan; Dahm, Lisa; Barin, Aiden; Cooper, Dan M.; Andriola, Tom; Byington, Carrie L.; Crews, Bridgit O.; Butte, Atul J.; Allen, Jeff; Medicine, School of Medicine
    Background: Real-world performance of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) must be assessed. We describe overall trends in the performance of serology tests in the context of real-world implementation. Methods: Six health systems estimated the odds of seropositivity and positive percent agreement (PPA) of serology test among people with confirmed SARS-CoV-2 infection by molecular test. In each dataset, we present the odds ratio and PPA, overall and by key clinical, demographic, and practice parameters. Results: A total of 15,615 people were observed to have at least one serology test 14-90 days after a positive molecular test for SARS-CoV-2. We observed higher PPA in Hispanic (PPA range: 79-96%) compared to non-Hispanic (60-89%) patients; in those presenting with at least one COVID-19 related symptom (69-93%) as compared to no such symptoms (63-91%); and in inpatient (70-97%) and emergency department (93-99%) compared to outpatient (63-92%) settings across datasets. PPA was highest in those with diabetes (75-94%) and kidney disease (83-95%); and lowest in those with auto-immune conditions or who are immunocompromised (56-93%). The odds ratios (OR) for seropositivity were higher in Hispanics compared to non-Hispanics (OR range: 2.59-3.86), patients with diabetes (1.49-1.56), and obesity (1.63-2.23); and lower in those with immunocompromised or autoimmune conditions (0.25-0.70), as compared to those without those comorbidities. In a subset of three datasets with robust information on serology test name, seven tests were used, two of which were used in multiple settings and met the EUA requirement of PPA ≥87%. Tests performed similarly across datasets. Conclusion: Although the EUA requirement was not consistently met, more investigation is needed to understand how serology and molecular tests are used, including indication and protocol fidelity. Improved data interoperability of test and clinical/demographic data are needed to enable rapid assessment of the real-world performance of in vitro diagnostic tests.
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    Real-world utilization of SARS-CoV-2 serological testing in RNA positive patients across the United States
    (Public Library of Science, 2023-02-10) Rodriguez-Watson, Carla V.; Sheils, Natalie E.; Louder, Anthony M.; Eldridge, Elizabeth H.; Lin, Nancy D.; Pollock, Benjamin D.; Gatz, Jennifer L.; Grannis, Shaun J.; Vashisht, Rohit; Ghauri, Kanwal; Valo, Gina; Chakravarty, Aloka G.; Lasky, Tamar; Jung, Mary; Lovell, Stephen L.; Major, Jacqueline M.; Kabelac, Carly; Knepper, Camille; Leonard, Sandy; Embi, Peter J.; Jenkinson, William G.; Klesh, Reyna; Garner, Omai B.; Patel, Ayan; Dahm, Lisa; Barin, Aiden; Cooper, Dan M.; Andriola, Tom; Byington, Carrie L.; Crews, Bridgit O.; Butte, Atul J.; Allen, Jeff; Medicine, School of Medicine
    Background: As diagnostic tests for COVID-19 were broadly deployed under Emergency Use Authorization, there emerged a need to understand the real-world utilization and performance of serological testing across the United States. Methods: Six health systems contributed electronic health records and/or claims data, jointly developed a master protocol, and used it to execute the analysis in parallel. We used descriptive statistics to examine demographic, clinical, and geographic characteristics of serology testing among patients with RNA positive for SARS-CoV-2. Results: Across datasets, we observed 930,669 individuals with positive RNA for SARS-CoV-2. Of these, 35,806 (4%) were serotested within 90 days; 15% of which occurred <14 days from the RNA positive test. The proportion of people with a history of cardiovascular disease, obesity, chronic lung, or kidney disease; or presenting with shortness of breath or pneumonia appeared higher among those serotested compared to those who were not. Even in a population of people with active infection, race/ethnicity data were largely missing (>30%) in some datasets-limiting our ability to examine differences in serological testing by race. In datasets where race/ethnicity information was available, we observed a greater distribution of White individuals among those serotested; however, the time between RNA and serology tests appeared shorter in Black compared to White individuals. Test manufacturer data was available in half of the datasets contributing to the analysis. Conclusion: Our results inform the underlying context of serotesting during the first year of the COVID-19 pandemic and differences observed between claims and EHR data sources-a critical first step to understanding the real-world accuracy of serological tests. Incomplete reporting of race/ethnicity data and a limited ability to link test manufacturer data, lab results, and clinical data challenge the ability to assess the real-world performance of SARS-CoV-2 tests in different contexts and the overall U.S. response to current and future disease pandemics.