Assessing Glycosylated Hemoglobin Thresholds for Development of Cardiovascular Disease by Racial and Ethnic Groups.

BACKGROUND: Diabetes is the strongest risk factor for cardiovascular disease, and although glycosylated hemoglobin (HbA1c) levels are known to vary by race, no racial and ethnic-specific diagnostic thresholds exist for diabetes in prediction of cardiovascular disease events. The purpose of this study is to determine whether HbA1c thresholds for predicting major adverse cardiovascular events (MACEs) differ among racial and ethnic groups. METHODS AND RESULTS: This is a retrospective cohort study of Kaiser Permanente Northern California adult members (n=309 636) with no history of cardiovascular disease who had HbA1c values and race and ethnicity data available between 2014 and 2019. Multivariable logistic regression was used to evaluate the odds of MACEs by the following racial and ethnic groups: Filipino, South Asian, East Asian, Black, White, and Hispanic. A Youden index was used to calculate HbA1c thresholds for MACE prediction by each racial and ethnic group, stratified by sex. Among studied racial and ethnic groups, South Asian race was associated with the greatest odds of MACEs (1.641 [95% CI, 1.456-1.843]; P<0.0001). HbA1c was a positive predictor for MACEs, with an odds ratio of 1.024 (95% CI, 1.022-1.025) for each 0.1% increment increase in HbA1c. HbA1c values varied between 6.0% and 7.6% in MACE prediction by race and ethnicity and sex. White individuals, South Asian individuals, East Asian women, and Black men had HbA1c thresholds for MACE prediction in the prediabetic range, between 6.0% and 6.2%. Black women, Hispanic men, and East Asian men had HbA1c thresholds of 6.2% to 6.6%, less than the typical threshold of 7.0% that is used as a treatment goal. CONCLUSIONS: Findings suggest that the use of race and ethnic- and sex-specific HbA1c thresholds may need to be considered in treatment goals and cardiovascular disease risk estimation.

Prevalence of Abortions Prior to and During the COVID-19 Pandemic in a Large Health Care System.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic presented patients with numerous barriers to accessing health care, including access to reproductive health services. The goal of this study was to assess the prevalence of abortion prior to versus during the COVID-19 pandemic within a large health care system to better understand if patients were able to access abortion care. METHODS: This was a retrospective, data-only cohort study examining the prevalence of abortion among patients aged 15 to 44 within Kaiser Permanente Northern California (KPNC) in the first 6 months of the COVID-19 stay-at-home order (April 1 to September 30, 2020) compared with a 6-month period in the year prior to the COVID-19 pandemic (April 1 to September 30, 2019). Analyses were conducted using χ2 and t tests, with a P value < .05 considered statistically significant. RESULTS: The prevalence of abortion among patients at risk of pregnancy in 2019 and 2020 was identical, at 0.04% (P = .93). Baseline characteristics were similar between the 2 periods. The prevalence of smoking among patients who had an abortion in 2019 was 11.24%, compared with 9.04% in 2020 (P = .0009). Additionally, 85.80% of patients had KPNC insurance 6 months after the abortion in 2019, compared with 89.53% in 2020 (P < .0001). DISCUSSION: The prevalence of abortion remained similar prior to and during the first 6 months of the COVID-19 pandemic within KPNC. Patients seeking abortion were less likely to smoke and were more likely to have consistent insurance 6 months after their abortion in 2020 versus 2019, potentially suggesting the COVID-19 pandemic resulted in healthier behaviors and more consistent access to health care. Despite stay-at-home orders and canceling of in-person clinic visits, abortion services remained accessible to a diverse population within a large health care system.

Adolescent Long-Acting Reversible Contraceptive Use, Same-Day Insertions, and Pregnancies Following a Quality Initiative.

OBJECTIVE: To compare long-acting reversible contraceptive (LARC) use, pregnancy rate, and same-day LARC insertion among adolescents before and after a Kaiser Permanente Northern California quality initiative. METHODS: A 2016 Kaiser Permanente Northern California initiative aimed to increase adolescent LARC access. Interventions included patient education resources, electronic protocols, and insertion training for pediatric, family medicine, and gynecology providers. This study examined a retrospective cohort of adolescents aged 15-18 years who used contraception before (2014-2015, n = 30,094) and after (2017-2018, n = 28,710) implementation. Contraceptive types included LARC (intrauterine device or implant), injectable, and contraceptive pill, patch, or ring. We reviewed a random sample of LARC users (n = 726) to identify same-day insertions. Multivariable analysis examined the effects of year of provision, age, race, ethnicity, LARC type, and counseling clinic. RESULTS: Preintervention, 12.1% of adolescents used LARC, 13.6% used injectable, and 74.3% used pill, patch, or ring. Postintervention, the proportions were 23.0%, 11.6%, and 65.4%, respectively, with the odds of LARC provision of 2.57 (95% confidence interval (CI) 2.44-2.72). The pregnancy rate decreased from 2.2% to 1.4% (p < .0001). Higher rates of pregnancy were observed with injectable contraception and in Black and Hispanic adolescents. Same-day LARC insertion rate was 25.1% without significant variation post intervention (OR 1.44, 95% confidence interval 0.93-2.23). Contraceptive counseling in gynecology clinics increased the odds of same-day provision, while non-Hispanic Black race lowered odds. DISCUSSION: A multifaceted quality intervention was associated with a 90% increase in LARC use and a 36% decrease in teenage pregnancy rate. Future directions may include promoting same-day insertions, targeting interventions in pediatric clinics, and focusing on racial equity.

Performance of the pooled cohort equation in South Asians: insights from a large integrated healthcare delivery system.

South Asian ethnicity is associated with increased atherosclerotic cardiovascular disease (ASCVD) risk and has been identified as a "risk enhancer" in the 2018 American College of Cardiology/American Heart Association Guidelines. Risk estimation and statin eligibility in South Asians is not well understood; we studied the accuracy of 10-years ASCVD risk prediction by the pooled cohort equation (PCE), based on statin use, in a South Asian cohort. This is a retrospective cohort study of Kaiser Permanente Northern California South Asian members without existing ASCVD, age range 30-70, and 10-years follow up. ASCVD events were defined as myocardial infarction, ischemic stroke, and cardiovascular death. The cohort was stratified by statin use during the study period: never; at baseline and during follow-up; and only during follow-up. Predicted probability of ASCVD, using the PCE was calculated and compared to observed ASCVD events for low < 5.0%, borderline 5.0 to < 7.5%, intermediate 7.5 to < 20.0%, and high ≥ 20.0% risk groups. A total of 1835 South Asian members were included: 773 never on statin, 374 on statins at baseline and follow-up, and 688 on statins during follow-up only. ASCVD risk was underestimated by the PCE in low-risk groups: entire cohort: 1.8 versus 4.9%, p < 0.0001; on statin at baseline and follow-up: 2.58 versus 8.43%, p < 0.0001; on statin during follow-up only: 2.18 versus 7.77%, p < 0.0001; and never on statin: 1.37 versus 2.09%, p = 0.12. In this South Asian cohort, the PCE underestimated risk in South Asians, regardless of statin use, in the low risk ASCVD risk category.

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.

Pain as Initial Presenting Symptom Is Associated With Delay to Seeking Medical Attention, Higher Risk of Relapse, and Shorter Survival in Patients With Early-Stage Extremity or Trunk Synovial Sarcoma.

BackgroundWhether the presenting symptom of pain vs mass impacts survival of early-stage synovial sarcoma is not known. Patients and MethodsThe authors investigated patients with early-stage extremity/trunk synovial sarcoma diagnosed from 2005 to 2017 at Kaiser Permanente Northern California for associations between the presenting symptom and survival. ResultsAmong 56 patients with early-stage extremity/trunk synovial sarcoma, median disease-free survival (DFS) was 20.3 months for the pain-only group (n = 19) vs 50.5 months for the mass ± pain group (n = 37) (p = 0.004), and median overall survival (OS) was 35.7 months vs 53.9 months (p = 0.009), respectively. Median DFS was 26.9 months for the pain ± mass group (n = 32) vs 48.6 months for the mass-only group (n = 24) (p = 0.047), whereas OS was not significantly different (49.6 vs. 53.6 months, p = 0.282). Pain at presentation was associated with a higher incidence of deep tumors and a higher risk of relapse. Cox regression model adjusting for age, sex, race, tumor location, tumor size, and wait-time to seek medical attention showed that pain at presentation was associated with 3-fold worse DFS and OS. ConclusionPain at presentation was an adverse risk factor for patients with early-stage extremity/trunk synovial sarcoma.

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.

Antipsychotic Medication Risk of Dementia and Death: A Propensity Matched Cohort Study.

OBJECTIVE: This study aimed to compare the incidence of dementia and all-cause mortality up to 20 years post-treatment in an index non-demented cohort between antipsychotic (AP) medication treatment and non-AP treatment groups. METHODS: All patients in Kaiser Permanente Northern California with a major psychiatric diagnosis between 01/01/1996 and 12/31/2000, age ≥ 50 years, and without dementia diagnosis were included. The study cohort was divided into a "user group", patients treated with AP for ≥ 365 days (n = 1,829), and a "non-user group", propensity score-matched on age, sex, and race (n = 9,145). The association between AP exposure and dementia or mortality during the follow-up period (01/01/2001-12/31/2015) was evaluated using Cox proportional hazard models adjusted for psychiatric diagnosis, comorbidities, and other medications. RESULTS: The user group had a hazard ratio (HR) of 2.2 (CI 1.8-2.7) for dementia and 1.3 (CI 1.2- 1.5) for death. The onset of dementia in the user group was significantly higher in patients aged ≤ 65 years (p < 0.001). The user group was sub-grouped into atypical, typical, and both; HR for dementia was 1.7 (CI 1.2-2.4), 2.5 (CI 1.9-3.1), and 1.8 (CI 1.4-2.4), respectively. Dementia and mortality were significantly higher in patients concurrently treated with benzodiazepine (HR 1.3; CI 1.2-1.5 and HR 1.4; CI 1.3-1.5) or tricyclic antidepressants (HR 1.2; CI 1.1-1.4 and HR 1.1; CI 1.0-1.2), respectively. CONCLUSION: Our preliminary results reveal an association between AP treatment and increased rates of both dementia and mortality. Future research is needed to substantiate our current findings.

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.

Association of the Timing of Postpartum Intrauterine Device Insertion and Breastfeeding With Risks of Intrauterine Device Expulsion.

IMPORTANCE: Intrauterine device (IUD) expulsion increases the risk of unintended pregnancy; how timing of postpartum IUD insertion and breastfeeding are associated with risk of expulsion is relevant to the benefit-risk profile. OBJECTIVE: To evaluate the association of postpartum timing of IUD insertion and breastfeeding status with incidence and risk of IUD expulsion. DESIGN, SETTING, AND PARTICIPANTS: The Association of Perforation and Expulsion of Intrauterine Devices (APEX-IUD) cohort study included women aged 50 years or younger with an IUD insertion between 2001 and 2018. The breastfeeding analysis focused on a subcohort of women at 52 or fewer weeks post partum with known breastfeeding status. The study was conducted using data from electronic health records (EHRs) at 4 research sites with access to EHR: 3 Kaiser Permanente sites (Northern California, Southern California, Washington) and the Regenstrief Institute (Indiana). Data analysis was conducted from June to November 2019. EXPOSURES: Timing of IUD insertion post partum was categorized into discrete time periods: 0 to 3 days, 4 days to 6 or fewer weeks, more than 6 weeks to 14 or fewer weeks, more than 14 weeks to 52 or fewer weeks, and non-post partum (>52 weeks or no evidence of delivery). Breastfeeding status at the time of insertion was determined from clinical records, diagnostic codes, or questionnaires from well-baby visits. MAIN OUTCOMES AND MEASURES: Incidence rates and adjusted hazard ratios (aHRs) were estimated using propensity scores to adjust for confounding. RESULTS: The full cohort included 326 658 women (mean [SD] age, 32.0 [8.3] years; 38 911 [11.9%] Asian or Pacific Islander; 696 [0.2%] Hispanic Black; 56 180 [17.2%] Hispanic other; 42 501 [13.0%] Hispanic White; 28 323 [8.7%] non-Hispanic Black; 137 102 [42.0%] non-Hispanic White), and the subcohort included 94 817 women. Most IUDs were levonorgestrel-releasing (259 234 [79.4%]). There were 8943 expulsions. The 5-year cumulative incidence of IUD expulsion was highest for insertions 0 to 3 days post partum (10.73%; 95% CI, 9.12%-12.61%) and lowest for insertions more than 6 weeks to 14 or fewer weeks post partum (3.18%; 95% CI, 2.95%-3.42%). Adjusted HRs using women with non-post partum IUD insertion as the referent were 5.34 (95% CI, 4.47-6.39) for those with postpartum insertion at 0 to 3 days; 1.22 (95% CI, 1.05-1.41) for those with postpartum insertion at 4 days to 6 or fewer weeks; 1.06 (95% CI, 0.95-1.18) for those with postpartum insertion at more than 6 to 14 or fewer weeks; and 1.43 (95% CI, 1.29-1.60) for those with postpartum insertion at more than 14 to 52 or fewer weeks. In the subcohort, 5-year cumulative incidence was 3.49% (95% CI, 3.25%-3.73%) for breastfeeding women and 4.57% (95% CI, 4.22%-4.95%) for nonbreastfeeding women; the adjusted HR for breastfeeding vs not breastfeeding was 0.71 (95% CI, 0.64-0.78). CONCLUSIONS AND RELEVANCE: In this study of real-world data, IUD expulsion was rare but more common with immediate postpartum insertion. Breastfeeding was associated with lower expulsion risk.

Prophylactic transdermal scopolamine for the reduction of postoperative length of stay after uterine aspiration at Kaiser Permanente Northern California from 2017-2018.

OBJECTIVE: To determine if transdermal scopolamine is associated with decreased postoperative nausea and vomiting and shorter length of stay in the postoperative care unit among patients undergoing uterine aspiration for abortion or early pregnancy loss. STUDY DESIGN: We conducted a retrospective cohort study at an integrated medical center that initiated a protocol to prescribe transdermal scopolamine to patients undergoing uterine aspiration under moderate sedation. We compared outcomes among patients who underwent uterine aspiration in 2017, before the institution enacted the protocol, with their counterparts in 2018, immediately after the institution instated the protocol. We reviewed patient charts for data on the postoperative length of stay, use of additional antiemetics, and a standardized clinician designated postoperative nausea and vomiting score. We analyzed outcomes by relevant demographic and clinical characteristics using chi-square or Fisher's exact tests for categorical variables and t tests for continuous variables. RESULTS: The final sample included 386 patients; 228 who did not receive scopolamine and 158 who did. The cohorts were comparable in terms of demographic and clinical characteristics. The cohort that received transdermal scopolamine had a similar mean postoperative length of stay (75.4 ± 54.1 vs 71.1 ± 50.8 minutes; p = 0.43). There were no differences in the proportions of patients who were provided additional antiemetics (26 ± 11.4 vs 17 ± 10.8; p = 0.84) or had transient vomiting and retching (3 ± 1.9 vs 3 ± 1.3; p = 0.69) between the cohorts. CONCLUSION: We found no evidence that prophylactic transdermal scopolamine reduces postoperative nausea, vomiting, or length of stay among patients undergoing uterine aspiration. IMPLICATIONS: Among patients who underwent uterine aspiration under moderate sedation, use of prophylactic transdermal scopolamine was not associated with shorter postoperative length of stay or lesser use of antiemetics. Prophylactic transdermal scopolamine is not likely to be useful for patients undergoing uterine aspiration and could be an unnecessary cost.

Healthcare utilization following minimally invasive apical prolapse repair in a large integrated healthcare system.

INTRODUCTION AND HYPOTHESIS: We sought to describe healthcare utilization (HU) following minimally invasive apical prolapse repair (MIAR) and its association with duration of hospital stay, patient characteristics, and perioperative factors. METHODS: This retrospective study included women undergoing MIAR within a large managed care organization between January 1, 2011, and June 30, 2018, and aimed to quantify HU within 30 days of surgery. HU was dichotomized into two groups: normal and high, based on typical postoperative utilization of healthcare resources. The primary outcome was the rate of normal versus high HU overall and by duration of hospital stay [discharge home on day of surgery versus postoperative day (POD) 1-2]. Multivariable logistic regression was performed to identify factors predictive of high HU. A p value of < 0.05 was considered statistically significant. RESULTS: Of the 4208 patients in our final cohort, 17% had high HU, while 83% were normal utilizers. High utilizers were more likely to have multiple comorbidities (p < 0.01) and a diagnosis of chronic pelvic pain (p = 0.02) and were less likely to be discharged on day of surgery (p < 0.01). A higher burden of disease, a concurrent mid-urethral sling or posterior colporrhaphy, and discharge on POD 1-2 were independently predictive of high HU. Within the high HU cohort, the most common type of unanticipated healthcare encounter was emergency department visit for urinary retention or pain. CONCLUSIONS: Same-day discharge after MIAR does not result in increased HU, even after adjusting for relevant demographic and clinical characteristics. Pre-existing chronic pain diagnoses, multiple comorbidities, and concurrent mid-urethral sling are associated with high HU in this population.

Pregnancy-Associated Spontaneous Coronary Artery Dissection: Clinical Characteristics, Outcomes, and Risk During Subsequent Pregnancy.

OBJECTIVES: Spontaneous coronary artery dissection (SCAD) is a common cause of pregnancy-associated myocardial infarction. METHODS: This study compares the clinical course and longitudinal follow-up of 22 cases of pregnancy-associated SCAD (P-SCAD) with 285 cases of non-pregnancy SCAD (NP-SCAD) from Kaiser Permanente Northern California between September 2002 through June 2017. RESULTS: Age in the P-SCAD group was significantly lower than in the NP-SCAD group (37.1 ± 5.7 years vs 50.9 ± 9.9 years, respectively; P<.001). Both cohorts were racially diverse, but the P-SCAD group had fewer whites (27.3% vs 50.7%; P=.03). The P-SCAD group had higher multigravidity (54.6% vs 31.4%; P=.03) and 68.2% were of advanced maternal age. The rates of ST-elevation myocardial infarction, ventricular tachycardia/fibrillation, and left main coronary dissection were similar. Proximal vessel dissection (31.8% vs 7.7%; P<.01), multiple vessel dissection (31.8% vs 9.5%; P<.01), and reduced ejection fraction at presentation (49.6 ± 10.5% vs 55.7 ± 10.4%; P=.01) were more common in the P-SCAD group vs the NP-SCAD group, respectively. More P-SCAD patients had cardiogenic shock and/or required intra-aortic balloon pump support (9.1% vs 1.1%; P=.04). Medical management was the principal coronary treatment strategy in both groups. P-SCAD patients experienced more major adverse cardiovascular events (50.0% vs 26.0%; P=.02), driven by persistent reduced ejection fraction ≤45% at follow-up (18.2% vs 5.3%; P=.04). Recurrent SCAD (18.2% vs 11.2%; P=.31) and cardiovascular death (0% vs 0.4%; P>.99) were similar in the P-SCAD group vs the NP-SCAD group, respectively. Seven patients had successful subsequent pregnancies without cardiac complications. CONCLUSION: P-SCAD has a higher-risk presentation, but similar long-term prognosis compared with NP-SCAD. In addition, subsequent pregnancy after SCAD may present acceptable risk.

Pre and Postoperative Analysis of Flatfoot Reconstruction Sparing the Talonavicular Joint.

Surgical correction of a flatfoot deformity is controversial. The purpose of our study was to evaluate the structural radiographic changes of the flatfoot deformity while maintaining the mobile adapter of the foot. We conducted a retrospective analysis of 56 patients that underwent this procedure comparing their pre- to postoperative angular changes during a follow-up period. The mean age of our study cohort was 53.6 (range, 20-77) years and mean follow-up period was 23 (range, 4-73) months. Radiographic union was achieved in 48 patients (86%). Forty-six patients (82%) had all required radiographs completed through final follow-up visit. We illustrated statistically significant changes to the talonavicular, Meary, talocalcaneal, calcaneal inclination, and talar declination angles, and navicular height at 3 months and final follow-up. This study suggests surgical correction of the flatfoot deformity that fused the subtalar but spared the talonavicular joint appears to achieve and maintain radiographic angular changes and achieve union.

Disparities in Speech Therapy for Voice Disorders Between English- and Non-English-Speaking Patients.

OBJECTIVES/HYPOTHESIS: To evaluate whether language of choice affects compliance with speech therapy for voice disorders. STUDY DESIGN: Retrospective chart review. METHODS: A retrospective study was performed at Kaiser Permanente Northern California to compare compliance with referrals to speech therapy for voice disorders between English- and non-English-speaking patients. Patients referred from January 2012 through December 2017 were included. Logistic regression models were used to calculate the adjusted odds ratios (aOR) and to determine social and demographic factors affecting compliance. RESULTS: Of 7,333 patients referred to speech therapy for a voice disorder, 7,171 were identified as English speaking and 162 as non-English speaking. The two cohorts were similar in terms of gender and proportion over 65 years of age, although non-English-speaking individuals were more likely to be Hispanic or Asian than English speakers, who were more likely to be White or African American. Overall compliance was lower among non-English-speaking patients than English speakers (63% vs 74%) (P = .0011). Logistic regression showed that the need for an interpreter was significantly associated with higher noncompliance (aOR 1.56, 95% CI 1.11-2.18), as was age less than 65 and income less than the study aggregate median income. Being multiracial or having a voice disorder of neurologic origin was associated with better compliance. CONCLUSION: This study demonstrates significant noncompliance with speech therapy for a variety of voice disorders. This problem is exacerbated for patients who do not speak English and who are younger, of lower income, or are referred for functional voice disorders. In-person interpreters or multilingual speech therapists may help to improve compliance. LEVEL OF EVIDENCE: IV Laryngoscope, 131:E2298-E2302, 2021.

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.

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.

Factors Associated With Long-Term Use of Percutaneous Tibial Nerve Stimulation for Management of Overactive Bladder Syndrome.

OBJECTIVES: The aims of the study were to estimate the rate of percutaneous tibial nerve stimulation maintenance therapy (PTNS-MT) among women with overactive bladder syndrome (OAB) and evaluate factors associated with long-term use of PTNS. METHODS: Patients who completed 12 weekly sessions of PTNS (PTNS-IN) for OAB between 2009 and 2016 within the Kaiser Permanente Northern California were identified using Current Procedural Terminology and International Classification of Diseases codes. Bivariate analysis was performed to compare demographic and clinical variables. A logistic regression model was used to determine factors associated with PTNS-MT compared with the use of alternative treatments following PTNS-IN. RESULTS: Of the 1331 patients who initiated PTNS for OAB, 347 (26%) completed PTNS-IN. Of these, 46% (n = 158) continued with long-term PTNS therapy, defined as completion of at least 8 additional PTNS sessions for a 32-week period. On bivariate analysis, those choosing PTNS-MT were more likely to be white (88%, P < 0.0001), nondiabetic (89%, P = 0.03), did not use anticholinergics before PTNS initiation (41%, P = 0.04), and had no prior surgery for stress incontinence (SUI; 84%, P = 0.01). In multivariable analysis, race was a significant factor with black, Hispanic, and Asian women less likely to continue with PTNS-MT. Women with prior use of first-line OAB therapy were 78% more likely to undergo PTNS-MT. Women with prior surgery for SUI were 53% less likely to continue PTNS-MT. CONCLUSIONS: Almost half of patients who completed PTNS-IN continued with PTNS-MT. White race, prior use of first-line OAB therapy, and no prior surgery for SUI were associated with long-term therapy.

South Asian ethnicity as a risk factor for coronary heart disease.

BACKGROUND AND AIMS: South Asian ethnicity has been associated with increased cardiovascular risk, in the context of a greater burden of traditional cardiovascular disease risk factors. We aimed to identify the 10-year incidence of coronary heart disease (CHD) in South Asians, as compared to other racial-ethnic groups, in a retrospective cohort study, using the Kaiser Permanente Northern California integrated health care system, and to understand whether traditional risk factors could explain differences in outcomes. METHODS AND RESULTS: A study cohort established in 2006, with 10-year follow-up, identified a total n = 341,309 patients, including 5149 South Asians, aged 30-70 years who underwent a screening lipid panel and had no prior history of CHD. There were a total of 460 (8.93%) patients with at least one cardiovascular event, including cardiovascular death, coronary artery revascularization, and myocardial infarction, in South Asians, as compared to 5.66% patients in the total population (p < 0.0001). In a multivariable logistic regression analysis, South Asian ethnicity, compared to White race, was associated with an adjusted odds ratio (aOR) = 2.04 (95%CI: 1.83, 2.28) in predicting the cardiovascular outcomes. CONCLUSIONS: South Asian ethnicity, even after adjustment for traditional risk factors, is associated with an increased risk of coronary heart disease outcomes. This risk was greater than other studied racial-ethnic groups and second only to diabetes in CHD risk prediction.

Identification and validation of uterine perforation, intrauterine device expulsion, and breastfeeding in four health care systems with electronic health records.

OBJECTIVE: To validate algorithms identifying uterine perforations and intrauterine device (IUD) expulsions and to ascertain availability of breastfeeding status at the time of IUD insertion. STUDY DESIGN AND SETTING: Four health care systems with electronic health records (EHRs) participated: Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA), and Regenstrief Institute (RI). The study included women ≤50 years of age with an IUD insertion. Site-specific algorithms using structured and unstructured data were developed and a sample validated by EHR review. Positive predictive values (PPVs) of the algorithms were calculated. Breastfeeding status was assessed in a random sample of 125 women at each research site with IUD placement within 52 weeks postpartum. RESULTS: The study population included 282,028 women with 325,582 IUD insertions. The PPVs for uterine perforation were KPNC 77%, KPSC 81%, KPWA 82%, and RI 47%; PPVs for IUD expulsion were KPNC 77%, KPSC 87%, KPWA 68%, and RI 37%. Across all research sites, breastfeeding status at the time of IUD insertion was determined for 94% of those sampled. CONCLUSIONS: Algorithms with a high PPV for uterine perforation and IUD expulsion were developed at 3 of the 4 research sites. Breastfeeding status at the time of IUD insertion could be determined at all research sites. Our findings suggest that a study to evaluate the associations of breastfeeding and postpartum IUD insertions with risk of uterine perforation and IUD expulsion can be successfully conducted retrospectively; however, automated application of algorithms must be supplemented with chart review for some outcomes at one research site due to low PPV.