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.

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.

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.

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.

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.

Early Outcomes of a High-Resolution Anoscopy-Based Anal Cancer Screening Program Among People With HIV Enrolled in an Integrated Health Care System.

BACKGROUND: Few studies have examined outcomes of high-resolution anoscopy (HRA)-based screening for people with HIV infection (PWH), a population at increased risk for anal cancer. SETTING: Large integrated health care system. METHODS: Cohort study of 13,552 people with HIV infection, comparing incidences of anal cancer and advanced anal cancer (higher stage, recurrence, death, or surgical salvage) before and after HRA became available (2008). Calendar time was divided as 1998-2007, 2008-2010, and 2011-2012. Rate ratios (RRs) were obtained from Poisson regression models with adjustment for baseline demographic and health variables. Cohort cases during 2008-2012 were included in a nested case-control study, evaluating association of screening with anal cancer (33 cases, 330 controls) and advanced anal cancer (19 cases, 190 controls). Odds ratios (ORs) for receipt of screening were obtained from conditional logistic regression models with adjustment for baseline demographic and health history variables. RESULTS: Compared with 1998-2007 (pre-HRA), 2008-2010 adjusted RRs were 1.32 [95% confidence intervals (CI): 0.77 to 2.27; P = 0.31] for anal cancer and 2.11 (95% CI: 0.99 to 4.48; P = 0.053) for advanced anal cancer; and 2011-2012 adjusted RRs were 0.35 (95% CI: 0.12 to 0.99; P = 0.048) for anal cancer and 0.23 (95% CI: 0.03 to 1.77; P = 0.16) for advanced anal cancer. Individual history of screening did not reach statistical significance for anal cancer (OR 1.7; 0.6-4.6) or advanced anal cancer (OR 0.44; 0.1-3.8). CONCLUSIONS: Despite the possible effect of secular trends, we found 2008-2012 incidence trends for anal cancer and advanced anal cancer that seem consistent with expected findings of a beneficial screening program.

Alternative Treatment Utilization Before Hysterectomy for Benign Gynecologic Conditions at a Large Integrated Health System.

STUDY OBJECTIVE: To investigate rates of utilization of alternative treatments before hysterectomy for benign gynecologic indications within a large integrated health care system. DESIGN: Retrospective cohort study of patients who underwent hysterectomies for benign gynecologic conditions between 2012 and 2014 (Canadian Task Force classification II-2). SETTING: Kaiser Permanente Northern California, a community-based integrated health system. PATIENTS: Women who underwent hysterectomy for a benign gynecologic condition between 2012 and 2014. INTERVENTIONS: From an eligible cohort of 6892 patients who underwent hysterectomy, a stratified random sample of 1050 patients were selected for chart review. Stratification was based on the proportion of indications for hysterectomy. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the use of alternative treatments before hysterectomy. Alternative treatments included oral hormone treatment, leuprolide, medroxyprogesterone intramuscular injections, a levonorgestrel intrauterine device, hormonal subdermal implants, endometrial ablation, uterine artery embolization, hysteroscopy, and myomectomy. Of the 1050 charts reviewed, 979 (93.2%) met the criteria for inclusion in this study. The predominant indication for hysterectomy was symptomatic myomas (54.4%), followed by abnormal uterine bleeding (29.0%), endometriosis (5.8%), pelvic pain (3.1%), dysmenorrhea (3.4%), and other (4.3%). The major routes of hysterectomy were laparoscopy (68.7%) and vaginal hysterectomy (13.4%). Before hysterectomy, 81.2% of patients tried at least 1 type of alternative treatment (33.8% with 1 treatment and 47.4% with at least 2 treatments), and 99.3% of patients were counseled regarding alternative treatments. Compared with younger women age <40 years, women age 45 to 49 years were less likely to use alternative treatments before hysterectomy (adjusted odds ratio, 0.41; 95% confidence interval, 0.21-0.76). There were no variations in treatment rates by socioeconomic status or between major racial and ethnic groups. The final pathological analysis identified myomas as the most common pathology (n = 637; 65.1%); 96 patients (9.8%) had normal uterine pathology. CONCLUSION: More than 80% of patients received alternative treatments before undergoing hysterectomy for a benign gynecologic condition. Additional investigation is warranted to assess alternative treatment use as it relates to preventing unnecessary hysterectomies.

Interdisciplinary treatment for vestibular dysfunction: the effectiveness of mindfulness, cognitive-behavioral techniques, and vestibular rehabilitation.

OBJECTIVE: To investigate whether an interdisciplinary program for vestibular patients improved health outcomes and health care utilization. STUDY DESIGN: Case series with chart review. SETTING: Outpatient neurotology clinic. SUBJECTS AND METHODS: Patients (N = 167) with dizziness attended an interdisciplinary neurotology clinic; 129 were offered group treatment. After an introductory session, group treatment included 5 sessions incorporating mindfulness, cognitive-behavioral techniques, and vestibular rehabilitation. Physical and emotional functioning, depression,anxiety, dizziness, impairment, coping, skill use, and patient satisfaction were measured with rating scales pre- and post-group treatment. Data from 51 patients (male/female = 14/37; age range, 25-82 years) were analyzed with paired t tests or nonparametric tests. Logistic regression analyzed predictors of outcome and utilization for 116 patients (male/female = 81/35; age range, 11-86 years) attending the interdisciplinary clinic, introductory session, and/or group. RESULTS: After group treatment, patients reported better mood (P = .0482); better physical (P = .0006) and mental (P = .0183) health; better functionality, coping, and skill use (Ps< .0001); less impairment (P < .0001); and fewer limitations from dizziness (P < .0001). Higher pretreatment levels of depression (P = .0216), poorer initial mental (P = .0164) or physical (P = .0059) health, and peripheral diagnosis (P = .0220) predicted better outcome. Group treatment decreased utilization more than the interdisciplinary clinic with (P = .0183) or without (P = .0196) the introductory session; 78% of patients with any level of participation showed less utilization. Clinic patients had fewer radiology procedures than group patients (P = .0365). Patients were highly satisfied with the program and found it more effective than previous treatment. CONCLUSION: Interdisciplinary treatment improves patient coping, functionality, and satisfaction and decreases overall health care utilization in vestibular patients.