Intrauterine device-related uterine perforation incidence and risk (APEX-IUD): a large multisite cohort study.

BACKGROUND: Reports of perforation risk related to intrauterine devices (IUDs) inserted immediately post partum and among non-post-partum individuals are scarce, and previous studies with only 12-month follow-ups underestimate the risk. Breastfeeding at IUD insertion and insertion within 36 weeks post partum have been associated with increased risk of uterine perforation. The aim of these analyses was to compare the incidence and risks of IUD-related uterine perforations by non-post-partum and post-partum intervals at IUD insertion, and among post-partum individuals, to assess the impact of breastfeeding on these outcomes. METHODS: We did a multisite cohort study in the USA, using electronic health records (EHR). Study sites were three health-care systems and a site that used data from a health-care information exchange. The study population included individuals who were aged 50 years or younger and had an IUD insertion between Jan 1, 2001, and April 30, 2018. Individuals were excluded if they had not been in the health-care system for at least 12 months before IUD insertion. The primary outcome for this analysis was any IUD-related uterine perforation diagnosis for the first IUD insertion in this time period. Both complete and partial IUD-related perforations were identified. Chart abstraction was done to validate EHR-based algorithms or confirm perforations. The crude rate and cumulative incidence of uterine perforation were evaluated by non-post-partum and post-partum intervals at IUD insertion in the full cohort, and by breastfeeding status in a subcohort of post-partum individuals. Cox models estimated crude and adjusted hazard ratios (aHRs). FINDINGS: Data from 326 658 individuals in the full cohort and 94 817 individuals in the post-partum subcohort were analysed. In the full cohort, we identified 1008 uterine perforations (51·2% complete), with the 5-year cumulative incidence being the lowest in the non-post-partum group (0·29%, 95% CI 0·26-0·34). The aHR for the post-partum interval relative to non-post partum ranged from 2·73 (95% CI 1·33-5·63; 0 to 3 days post partum) to 6·71 (4·80-9·38; 4 days to ≤6 weeks post partum). The post-partum subcohort of individuals with breastfeeding information had 673 uterine perforations (62% complete), with a 5-year cumulative incidence of 1·37% (95% CI 1·24-1·52) and an increased risk with breastfeeding (aHR 1·37, 95% CI 1·12-1·66). INTERPRETATION: Although the risk for uterine perforation with IUD insertion 4 days to 6 weeks or less post partum is nearly seven times that of insertion non-post partum, perforation remains an incredibly rare event for all clinical time points. Despite a slight increased risk of perforation with breastfeeding at IUD insertion, the benefits of breastfeeding and effective contraception generally outweigh risks and should have little clinical impact. Therefore, IUD insertion timing should be based on individual desire for IUD contraception and patient convenience to assure an IUD insertion can occur. Careful follow-up of individuals at higher risk of uterine perforation is warranted. FUNDING: Bayer AG.

Design of the Association of Uterine Perforation and Expulsion of Intrauterine Device study: a multisite retrospective cohort study.

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.

Evaluating the Impact of Mobile Phone Technology on Health Outcomes for Latinos with Type 2 Diabetes.

OBJECTIVES: To assess whether a Spanish-language text messaging program helps Latinos with diabetes better manage their disease. METHODS: Spanish-speaking Latinos with type 2 diabetes and HbA1c ≥ 8% (N = 38) were recruited January 1, 2016-May 31, 2016, at a large integrated healthcare delivery system. Participants received 1-3 Spanish-language text messages about diabetes self-care per day for 3 months with an optional 3-month extension. The Wilcoxon signed-rank test for paired data was used to compare pre-post intervention HbA1c. The Wilcoxon-Mann-Whitney nonparametric test was used to compare changes in HbA1c across groups. RESULTS: After 3 months, the median HbA1c reduction overall was 1.4 percentage points (IQR: 0.5-3.3, p < 0.01). Latinos having pre-intervention HbA1c > 10.0% had a greater reduction in median HbA1c (3.8, IQR: 0.5-5.3) compared with those having pre-intervention HbA1c ≤ 10.0% (0.9, IQR: 0.1-1.9, p < 0.05). This reduction in median HbA1c persisted after 6 months (1.3, IQR: 0.2-2.9, p < 0.01). CONCLUSION: A Spanish-language text messaging program was an effective way to improve glycemic control for Latinos with type 2 diabetes. POLICY IMPLICATIONS: Culturally and linguistically tailored text messaging programs for managing diabetes should be considered.

Breast cancer risk after hysterectomy with and without salpingo-oophorectomy for benign indications.

BACKGROUND: Breast cancer risk has been extensively studied in women with genetic predisposition, that is, mutations in breast cancer genes 1 and 2. Although there are guidelines for performing bilateral salpingo-oophorectomies in individuals with specific genetic risks, oophorectomies are also performed in many women considered to be at average risk of developing breast cancer. The risk of breast cancer in women with average risk who undergo hysterectomy with bilateral salpingo-oophorectomy for benign indications is less clear. OBJECTIVE: This study aimed to estimate breast cancer risk after hysterectomy with and without concomitant bilateral salpingo-oophorectomy for benign indications. STUDY DESIGN: From 2001 to 2015, women aged 18 years and older from Kaiser Permanente Northern California who underwent hysterectomy alone and hysterectomy with bilateral salpingo-oophorectomy were identified using the International Classification of Diseases, Ninth Revision, procedure and Current Procedural Terminology codes. Women with a breast cancer gene mutation and previous history of breast cancer or gynecologic cancer were excluded. Descriptive and bivariate analyses were used to describe and compare demographic and clinical characteristics. Breast cancer incidence rates were calculated per 100,000 person-years. Survival analysis and Cox proportional hazard models were conducted to compare the risk of developing breast cancer. RESULTS: Of 49,215 women who underwent hysterectomy, 19,826 had hysterectomy with bilateral salpingo-oophorectomy. Whites, Hispanics, blacks, Asians, and other or unknown comprised 51.2%, 20.3%, 12.7%, 10.4%, and 5.3% of the study population, respectively. The average age of women with hysterectomy alone was 45.5 years compared with 50.8 years for those who had hysterectomy with bilateral salpingo-oophorectomy. During the study period, 915 women received a diagnosis of breast cancer. Age-specific breast cancer incidence rates were higher in women older than 60 years with oophorectomy than hysterectomy alone (471.2 [95% confidence interval, 386.2-556.2] vs 463.0 [95% confidence interval, 349.6-576.5], respectively). After controlling for age, race, income, and Charlson Comorbidity Index, women with bilateral salpingo-oophorectomy had a 14% lower risk of breast cancer than women with hysterectomy alone (hazard ratio, 0.86; 95% confidence interval, 0.75-0.98). All-cause mortality was higher with oophorectomy than hysterectomy alone (64.4% vs 35.6%, P<.0001, respectively). CONCLUSION: Women with concurrent bilateral salpingo-oophorectomy for benign indications had a lower risk of breast cancer than those who had hysterectomy alone. However, all-cause mortality was higher in women with oophorectomy. Perimenopausal patients undergoing hysterectomy for benign indications should be counseled on the risks and benefits of oophorectomy at the time of surgery.

Preventing early-onset group B streptococcal sepsis: is there a role for rescreening near term?

Objective: The Centers for Disease Control and Prevention 2010 guidelines recommend group B streptococcus (GBS) screening at 35-37-week gestation to identify women with positive cultures who should receive intrapartum antibiotics and notes that the predictive value of a negative culture declines after 5 weeks. However, despite the lack of evidence, current guidelines do not recommend rescreening for those screened between 35 and 37 weeks. Our objectives were to investigate the rate of conversion from negative to positive results in women rescreened after appropriate screening at 35-37-week gestation and to examine the impact of rescreening on the use of intrapartum antibiotics. Additionally, we examined cases of early-onset group B streptococcal sepsis (early-onset GBS) in term neonates.Methods: We performed a retrospective cohort study of women delivering liveborn infants 1 January, 2010-31 December, 2014 in Kaiser Permanente Northern California. Data were obtained from database extraction and chart review.Results: We identified 135,585 women with GBS screening at 35-37-week gestation; 4511 (3.3%) women were rescreened. Of the 3860 (85.6%) initially screened negative, 218 (5.6%) converted to positive. Fewer women in the discordant negative to positive group received GBS prophylaxis prior to delivery compared with women with a single positive culture (65.9 versus 92.3%, p < .001). In the discordant negative to positive group, results were available at the time of delivery in 133 of 217 subjects (61.3%). There were 18 cases of early-onset GBS at term (0.10 per 1000 livebirths); the majority of cases occurred among women with negative screening.Conclusion: Our results provide support for the current CDC recommendation against rescreening near term for those women already screened at 35-37-week gestation given the low rate of conversion from negative to positive, and the extremely low rate of early-onset GBS in the screened population.

Are Health Plan Design and Prior Use of Long-Acting Reversible Contraception Associated with Pregnancy Intention?

BACKGROUND: In 2007, high-deductible plans were added to the primarily nondeductible Kaiser Permanente Northern California (KPNC) integrated health plan, which had covered 100% of device and procedure costs of long-acting reversible contraception (LARC) for members regardless of prescription/visit copay amount. We hypothesized that nondeductible plans and prior LARC use decreased unintended pregnancy. OBJECTIVE: The purpose of this study was to determine if health plan design (nondeductible vs. deductible) and LARC use before pregnancy were associated with pregnancy intention. METHODS: In this retrospective cohort study, women aged 15-44 as of the index date of June 30, 2010 were followed from January 1, 2010 to December 31, 2012 for evidence of pregnancy (n = 65,989). Health plan design, copays, contraceptive method used most recently before the pregnancy, and self-reported pregnancy intention status (intended, mistimed, unwanted) were obtained from electronic medical records. Logistic regression models were developed to determine if various health plan designs, copays, or prior LARC use were associated with pregnancy intention, controlling for potential confounders such as age, race/ethnicity, marital status, education/income, parity, and comorbidities. RESULTS: In all models, LARC use before pregnancy versus non-LARC use was significantly related to intended pregnancies (all models: odds ratio [OR] = 2.26, 95% confidence interval [CI] 2.06-2.48). Women with deductible plans with healthcare spending accounts (HSA) were more likely to report intended pregnancies versus women with nondeductible plans (all models: OR = 1.2, 95% CI 1.04-1.30). In stratified analyses, high income/high education was a significant predictor of intended pregnancy regardless of race/ethnicity. CONCLUSION: LARC use before pregnancy and having an HSA were associated with intended pregnancy.

Does increased experience with laparoscopic cholecystectomy yield more complex bile duct injuries?

BACKGROUND: Two decades since the advent of laparoscopic cholecystectomy, the rate of bile duct injuries still remains higher than in the open cholecystectomy era. METHODS: The rate and complexity of bile duct injuries was evaluated in 83,449 patients who underwent laparoscopic cholecystectomy between 1995 and 2008 in the Kaiser Permanente Northern California system. Fifty-six surgeons who performed a laparoscopic cholecystectomy in the past were surveyed to determine factors that predispose to bile duct injuries. RESULTS: The overall incidence of bile duct injuries was .10%; 59.5% of the 84 injuries were cystic duct leaks. Incidence varied slightly from .10% (1995-1998) to .08% (1999-2003) and .12% (2004-2008). There was a trend toward more proximal injuries (injury <2 cm from the bifurcation: 14.3% to 44.4% to 50.0% of major injuries). The misinterpretation of anatomy was cited by 92.9% of surgeons as the primary cause of bile duct injuries; 70.9% cited a lack of experience as a contributing factor. CONCLUSIONS: Laparoscopic cholecystectomy has an overall low risk of bile duct injuries; the rate remains constant, but injury complexity may have increased over time.

Documentation of contraception and pregnancy when prescribing potentially teratogenic medications for reproductive-age women.

BACKGROUND: Certain medications are identified by the U.S. Food and Drug Administration (FDA) as class D or X because they increase the risk for birth defects if used during pregnancy. OBJECTIVE: To assess pregnancy rates and the frequency of contraceptive counseling documented with prescriptions for class D or X drugs filled by women of reproductive age. DESIGN: Description of prescriptions filled in 2001. SETTING: A large health maintenance organization in northern California in 2001. PATIENTS: 488,175 women age 15 to 44 years who filled a total of 1,011,658 class A, B, D, or X prescriptions. MEASUREMENTS: Medications dispensed, contraceptive counseling, and pregnancy testing. RESULTS: A class D or X prescription was filled by 1 of every 6 women studied. Women who filled a prescription for class D or X medications were no more likely than women who filled prescriptions for safer, class A or B medications to have received contraceptive counseling, filled a contraceptive prescription, or been sterilized (48% vs. 51% of prescriptions). There was little variation by clinical indication in rates of contraceptive counseling with class D or X prescriptions, except for isotretinoin. Women who filled a class D or X prescription were only slightly less likely to have a pregnancy documented within 3 months than women filling a class A or B prescription (1.0% vs. 1.4% of prescriptions). LIMITATIONS: International Classification of Diseases, Ninth Revision, codes underestimate contraceptive counseling. Documentation of a positive pregnancy test after filling a prescription may overestimate medication use in early pregnancy. Women who filled several prescriptions are overrepresented in prescription analyses. CONCLUSION: Prescriptions for potentially teratogenic medications are frequently filled by women of childbearing age without documentation of contraceptive counseling.