Browsing by Subject "evidence"

Now showing 1 - 4 of 4
  • Thumbnail Image
    Item
    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.
  • Thumbnail Image
    Item
    Evidentiary Issues and Digital Evidence
    (2016) Boyne, Shawn; Robert H. McKinley School of Law
  • Thumbnail Image
    Item
    Social Media and Electronic Discovery: A Potential Source of Evidence in Bankruptcy Proceedings
    (2011) Hook, Sara Anne; Taht, Katherine A.
    This article is the second in a series about electronic discovery in bankruptcy. The first article covered the basics of electronic discovery, including history, rules and resources. This article will discuss the discoverability of information found on social media sites such as Facebook, YouTube and LinkedIn, and how these sites can be rich sources of evidence for bankruptcy cases. Future articles will apply electronic discovery principles to bankruptcy law practice, review current technologies that can assist with electronic discovery before and during litigation and introduce examples where the failure to handle the electronic discovery process properly resulted in sanctions and the lessons that can be learned from these examples.
  • Thumbnail Image
    Item
    Vaccine hesitancy communication: What counts as evidence
    (Elsevier, 2018) Parrish-Sprowl, John; Communication Studies, School of Liberal Arts
    The evidence base for vaccine hesitancy communication is generally confined to research focused on the content of the message rather than the process of communication. This has important consequences, because shifting focus to encompass the process of communicating, and not just on the content of content message being conveyed; opens the possibility of greater insight and understanding regarding the conversation health care workers have with those who are vaccine hesitant, creating increased chances of acceptance.