Demographic, Reproductive, and Medical Risk Factors for Intrauterine Device Expulsion.

OBJECTIVE: To explore to what extent intrauterine device (IUD) expulsion is associated with demographic and clinical risk factors. METHODS: The APEX-IUD (Association of Perforation and Expulsion of IntraUterine Devices) study was a U.S. cohort study using electronic health records from three integrated health care systems (Kaiser Permanente Northern California, Southern California, and Washington) and a health care information exchange (Regenstrief Institute). These analyses included individuals aged 50 years or younger with IUD insertions from 2001 to 2018. Intrauterine device expulsion cumulative incidence and incidence rates were estimated. Using Cox regression models, hazard ratios with 95% CIs were estimated before and after adjustment for risk factors of interest (age, race and ethnicity, parity, body mass index [BMI], heavy menstrual bleeding, and dysmenorrhea) and potential confounders. RESULTS: In total, 228,834 individuals with IUD insertion and no delivery in the previous 52 weeks were identified (184,733 [80.7%] with levonorgestrel-releasing intrauterine system). Diagnosis of heavy menstrual bleeding-particularly a diagnosis in both recent and past periods-was the strongest risk factor for IUD expulsion. Categories with the highest risk of IUD expulsion within each risk factor included individuals diagnosed with overweight, obesity, and morbid obesity; those in younger age groups, especially among those aged 24 years or younger; and in those with parity of four or more. Non-Hispanic White individuals had the lowest incidence and risk, and after adjustment, Asian or Pacific Islander individuals had the highest risk. Dysmenorrhea was not independently associated with expulsion risk when adjusting for heavy menstrual bleeding. CONCLUSION: Most risk factors for expulsion identified in this study appear consistent with known physiologic factors that affect uterine anatomy and physiology (age, BMI, heavy menstrual bleeding, parity). The increased risk of IUD expulsion among individuals of color warrants further investigation. Intrauterine devices are an effective long-term contraceptive; expulsion is uncommon, but patients should be counseled accordingly. FUNDING SOURCE: Bayer AG. CLINICAL TRIAL REGISTRATION: EU PAS register, EUPAS33461.

Association between intrauterine device type and risk of perforation and device expulsion: results from the Association of Perforation and Expulsion of Intrauterine Device study.

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 Device 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.

Association between menorrhagia and risk of intrauterine device-related uterine perforation and device expulsion: results from the Association of Uterine Perforation and Expulsion of Intrauterine Device study.

BACKGROUND: Intrauterine devices are effective instruments for contraception, and 1 levonorgestrel-releasing device is also indicated for the treatment of heavy menstrual bleeding (menorrhagia). OBJECTIVE: To compare the incidence of intrauterine device expulsion and uterine perforation in women with and without a diagnosis of menorrhagia within the first 12 months before device insertion STUDY DESIGN: This was a retrospective cohort study conducted in 3 integrated healthcare systems (Kaiser Permanente Northern California, Southern California, and Washington) and a healthcare information exchange (Regenstrief Institute) in the United States using electronic health records. Nonpostpartum women aged ≤50 years with intrauterine device (eg, levonorgestrel or copper) insertions from 2001 to 2018 and without a delivery in the previous 12 months were studied in this analysis. Recent menorrhagia diagnosis (ie, recorded ≤12 months before insertion) was ascertained from the International Classification of Diseases, Ninth and Tenth Revision, Clinical Modification codes. The study outcomes, viz, device expulsion and device-related uterine perforation (complete or partial), were ascertained from electronic medical records and validated in the data sources. The cumulative incidence and crude incidence rates with 95% confidence intervals were estimated. Cox proportional hazards models estimated the crude and adjusted hazard ratios using propensity score overlap weighting (13-16 variables) and 95% confidence intervals. RESULTS: Among 228,834 nonpostpartum women, the mean age was 33.1 years, 44.4% of them were White, and 31,600 (13.8%) had a recent menorrhagia diagnosis. Most women had a levonorgestrel-releasing device (96.4% of those with and 78.2% of those without a menorrhagia diagnosis). Women with a menorrhagia diagnosis were likely to be older, obese, and have dysmenorrhea or fibroids. Women with a menorrhagia diagnosis had a higher intrauterine device-expulsion rate (40.01 vs 10.92 per 1000 person-years) than those without, especially evident in the first few months after insertion. Women with a menorrhagia diagnosis had a higher cumulative incidence (95% confidence interval) of expulsion (7.00% [6.70-7.32] at 1 year and 12.03% [11.52-12.55] at 5 years) vs those without (1.77% [1.70-1.84] at 1 year and 3.69% [3.56-3.83] at 5 years). The risk of expulsion was increased for women with a menorrhagia diagnosis vs for those without (adjusted hazard ratio, 2.84 [95% confidence interval, 2.66-3.03]). The perforation rate was low overall (<1/1000 person-years) but higher in women with a diagnosis of menorrhagia vs in those without (0.98 vs 0.63 per 1000 person-years). The cumulative incidence (95% confidence interval) of uterine perforation was slightly higher for women with a menorrhagia diagnosis (0.09% [0.06-0.14] at 1 year and 0.39% [0.29-0.53] at 5 years) than those without it (0.07% [0.06-0.08] at 1 year and 0.28% [0.24-0.33] at 5 years). The risk of perforation was slightly increased in women with a menorrhagia diagnosis vs in those without (adjusted hazard ratio, 1.53; 95% confidence interval, 1.10-2.13). CONCLUSION: The risk of expulsion is significantly higher in women with a recent diagnosis of menorrhagia. Patient education and counseling regarding the potential expulsion risk is recommended at insertion. The absolute risk of perforation for women with a recent diagnosis of menorrhagia is very low. The increased expulsion and perforation rates observed are likely because of causal factors of menorrhagia.

Subdermal Contraceptive Implant Insertion Trends and Retention in Adolescents.

STUDY OBJECTIVE: There is growing advocacy for use of long-acting reversible contraception among sexually active adolescents. Our primary aims were to evaluate the etonogestrel subdermal contraceptive implant (SCI) insertion trends among adolescents, as well as SCI retention at 1, 2, and 3 years, indications for removal, and to identify pregnancies that occurred during SCI use. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: A retrospective cohort study was conducted of adolescents aged 13-19 years with SCI insertions in 2008-2014 within a large integrated health care system. Demographic and clinical characteristics included age, race/ethnicity, body mass index, gravidity, parity, insertions, reinsertions, indications for removal, and pregnancy. Electronic medical record review was conducted on a randomized sample of 540 adolescents with insertions during 2008-2011 for the retention objective to validate electronically extracted variables. Analyses included descriptive statistics, survival analysis with Kaplan-Meier estimates for implant retention and Cochran-Armitage trend test for insertions according to year during 2008-2014. RESULTS: Most adolescent SCI users were non-Hispanic white (43%), or Hispanic (34.2%) and 16 years or older (84.2%) at the time of insertion. Overall, 1-, 2-, and 3-year retention rates were 78.6%, 59.4%, and 26.2%, respectively, with retention at 44.3% at 2 years 9 months (indicative of removal of method for near expiration of 3-year device). The insertion rate trend showed statistically significant increases annually, from 0.14% in 2008 to 0.91% in 2014; P < .0001. No pregnancies were documented during implant use. The most common indication for SCI removal was device expiration. CONCLUSION: SCI insertions increased annually among adolescents, with more than a sixfold increase over the 6-year study period, and more than half of the SCIs were retained through 2 years of use. The most common indication of SCI removal was completion of Food and Drug Administration-approved duration.

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.

The Association of Spanish Language Preference with Advance Directive Completion.

BACKGROUND/OBJECTIVES: Hispanics have lower advance directive (AD) completion than non-Hispanic Whites. Few studies have assessed the role of language preference in end-of-life planning. We investigated whether language preference and needing an interpreter affected AD completion among older adults in an integrated health system. DESIGN: Retrospective cohort investigation of electronic medical records. SETTING: Northern California integrated health system. PARTICIPANTS: A total of 620,948 Hispanic and non-Hispanic White patients, aged 55 years and older, between January 1, 2013, and December 31, 2017. MEASUREMENTS: Descriptive statistics and bivariate analysis were performed to compare AD completion among non-Hispanic Whites, Hispanics, and Hispanic subgroups by language preference (English speaking, Spanish speaking, and needed interpreter). We conducted multivariable logistic regression to determine the relationship between language preference and having an AD while controlling for demographic, clinical, and utilization factors. RESULTS: We found 20.3% of non-Hispanic Whites (n = 512,577) and 10.9% of Hispanics (n = 108,371) had completed an AD. Among Hispanics, after controlling for demographic, clinical, and utilization factors, compared with Spanish speakers requiring an interpreter, English speakers had nearly two-fold increased odds of completing an AD (adjusted odds ratio (aOR) = 2.6; 95% confidence interval (CI) = 2.4-2.9), whereas Spanish speakers not requiring an interpreter had 20% increased odds (aOR = 1.2; 95% CI = 1.1-1.3). Additional predictors of successful AD completion were being female, being older, having more comorbidities, having more hospital and emergency department visits, and having higher socioeconomic status. There were no differences associated with primary care provider characteristics. CONCLUSION: These findings indicate the need for a tailored outreach to Hispanics, particularly among those subgroups who require the need of an interpreter, to reduce AD completion disparities.

Rates and Predictors of Vaccinations Among Inflammatory Bowel Disease Patients Receiving Anti-Tumor Necrosis Factor Agents.

BACKGROUND: As an important quality measure, the rates of recommended immunizations among immunocompromised inflammatory bowel disease (IBD) patients in community practice have not been well studied. AIMS: This study sought to investigate the rates and predictors of recommended immunizations and screening tests among IBD patients receiving anti-tumor necrosis factor (TNF) therapy in a large integrated healthcare organization. METHODS: We conducted a retrospective cohort study of 1401 IBD patients on anti-TNF therapy between 2010 and 2013 within the Kaiser Permanente Northern California healthcare system. The rates of vaccinations and screening tests were quantified, and the associated predictors were investigated. RESULTS: Vaccination rates for influenza and pneumococcus were 43.5 and 24.1%, respectively. The majority of patients (73.7%) received hepatitis B screening and/or vaccine. Patients receiving infliximab had higher rates of pneumococcal vaccine (P = 0.002), hepatitis B screening (P < 0.001), and tuberculin skin test (P < 0.001) compared with patients receiving adalimumab. Older patient age (≥50 years) was associated with higher likelihood of having HBsAg test (odds ratio [OR] 1.5, 95% confidence interval [CI] 1.2-2.0, P = 0.002), influenza vaccine (OR 2.6 [2.1-3.4], P < 0.001), and pneumococcal vaccine (OR 4.0 [3.0-5.3], P < 0.001). In contrast, older providers (≥50 years) were associated with significantly lower likelihood of their patients' having hepatitis A and B screening tests, and pneumococcal vaccination. CONCLUSIONS: The rates of immunizations for IBD patients receiving anti-TNF treatment were lower than recommended. Structured reminders for vaccinations and education for both patients and providers (older physicians in particular) may prove beneficial in improving immunization rates among immunocompromised IBD patients.

Diagnosis and predictors of sessile serrated adenoma after educational training in a large, community-based, integrated healthcare setting.

BACKGROUND AND AIMS: Sessile serrated adenomas (SSAs) are precursors of 15% to 30% of colorectal cancers but are frequently underdiagnosed. We sought to measure the SSA detection rate (SDR) and predictors of SSA detection after educational training for community gastroenterologists and pathologists. METHODS: Colonoscopy and pathology data (2010-2014) from 3 medical centers at Kaiser Permanente Northern California were accessed electronically. Gastroenterologists and pathologists attended a training session on SSA diagnosis in 2012. Mean SDRs and patient-level predictors of SSA detection post-training (2013-2014) were investigated. RESULTS: Mean SDRs increased from .6% in 2010-2012 to 3.7% in 2013-2014. The increase in the detection of proximal SSAs was accompanied by a decrease in the detection of proximal hyperplastic polyps (HPs). Among 34,161 colonoscopies performed in 2013 to 2014, SDRs for screening, fecal immunochemical test positivity, surveillance, and diagnostic indication were 4.2%, 4.5%, 4.9%, and 3.0%, respectively. SSA detection was lower among Asians (adjusted odds ratio [aOR], .46; 95% confidence interval [CI], .31-.69) and Hispanics (aOR, .59; 95% CI, .36-.95) compared with non-Hispanic whites and higher among patients with synchronous conventional adenoma (aOR, 1.46; 95% CI, 1.15-1.86), HP (aOR, 1.74; 95% CI, 1.30-2.34), and current smokers (aOR, 1.78; 95% CI, 1.17-2.72). SDRs varied widely among experienced gastroenterologists, even after training (1.1%-8.1%). There was a moderately strong correlation between adenoma detection rate (ADR) and SDR for any SSA (r = .64, P = .0003) and for right-sided SSAs (r = .71, P < .0001). CONCLUSIONS: Educational training significantly increased the detection of SSA, but a wide variation in SDR remained across gastroenterologists. SSA detection was inversely associated with Asian and Hispanic race/ethnicity and positively associated with the presence of conventional adenoma, HP, and current smoking. There was a moderately strong correlation between ADR and SDR.

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.

Significant Racial Disparities Exist in Noncardia Gastric Cancer Outcomes Among Kaiser Permanente's Patient Population.

INTRODUCTION: Racial and ethnic differences in gastric cancer are not well understood. This study sought to compare the clinicopathological features and survival of noncardia gastric adenocarcinoma (NCGA) patients with different racial/ethnic backgrounds in Kaiser Permanente Northern California (KPNC), a large integrated health care system. METHODS: This was a retrospective cohort study of 1,366 patients with newly diagnosed NCGA between 2000 and 2010. The subjects were categorized into four racial/ethnic groups: non-Hispanic Whites, Blacks, Asians, and Hispanics. Clinicopathological information and survival data were obtained from the KPNC electronic databases and compared among the four racial/ethnic groups. RESULTS: The incidence of NCGA declined in Blacks and Whites, but remained stable in Asians and Hispanics. Whites had a lower incidence of NCGA compared with non-Whites. Asians and Hispanics were diagnosed at a younger age compared with Whites (mean age at diagnosis: 66, 63, and 72 years, respectively; P < 0.0001). Diffuse/mixed histological type (Lauren classification) was more prevalent in Asians and Hispanics than in Whites and Blacks (46 and 45 vs. 36 and 29 %, respectively, P = 0.001). History of Helicobacter pylori testing was associated with better survival. Asians had the highest survival rates at 1, 2, and 5 years, while Whites had the lowest (P < 0.0001). CONCLUSIONS: Significant racial/ethnic differences exist in patients with noncardia gastric cancer. Asians and Hispanics were younger at diagnosis and had more diffuse/mixed histological type. Asians had the highest survival, while Whites had the lowest. Such differences may be related to biological, environmental, and treatment-related factors.

The role of integrated care pathways in improving the patient experience.

This, the first in a series of two articles, will explore how an integrated care pathway was developed to improve care delivery for patients with breast cancer in Salisbury. This approach can be adapted to benefit both the patient and the multidisciplinary team in other disease areas and addresses NHS targets for increasing efficiency and promoting patient-centred care.