IMPORTANCE Intrauterine device (IUD) expulsion increases the risk of unintended pregnancy; how ti... more 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, (continued) Key Points Question Are timing of intrauterine device (IUD) insertion post partum and breastfeeding associated with the risk of IUD expulsion? Findings In this cohort study of 326 658 women, 5-year cumulative incidence of IUD expulsion was highest among women with postpartum IUD insertions at 0 to 3 days and lowest for those with insertions at more than 6 weeks to 14 or fewer weeks. IUD expulsion was higher for women who were not breastfeeding. Meaning In this study, immediate postpartum IUD insertion was associated with increased risk of IUD expulsion relative to later insertions, and breastfeeding was associated with lower expulsion risk.
Journal of Patient-Centered Research and Reviews, 2017
Introduction: Uterine fibroids are the most common benign tumors of the uterus and are associated... more Introduction: Uterine fibroids are the most common benign tumors of the uterus and are associated with considerable morbidity. Diagnosis codes have been used to identify fibroid cases, but their accuracy, especially for incident cases, is uncertain. Methods: We performed medical record review on a random sample of 617 women who received a fibroid diagnosis during 2012-2014 to assess diagnostic accuracy for incident fibroids. We developed 2 algorithms aimed at improving incident case-finding using classification and regression tree analysis that incorporated additional electronic health care data on demographics, symptoms, treatment, imaging, health care utilization, comorbidities and medication. Algorithm performance was assessed using medical record as gold standard. Results: Medical record review confirmed 482 fibroid cases as incident, resulting a 78 percent positive predictive value (PPV) for incident cases based on diagnosis codes alone. Incorporating additional electronic data, the first algorithm classified 395 women with a pelvic ultrasound on diagnosis date but none before as incident cases. Of these, 344 were correctly classified, yielding an 87 percent PPV, 71 percent sensitivity, and 62 percent specificity. A second algorithm built on the first algorithm and further classified women based on a fibroid diagnosis code of 218.9 in 2 years after incident diagnosis and lower body mass index; yielded 93 percent PPV, 53 percent sensitivity, and 85 percent specificity. Conclusions: Compared to diagnosis codes alone, our algorithms using fibroid diagnosis codes and additional electronic data improved identification of incident cases with higher PPV, and high sensitivity or specificity to meet different aims of future studies seeking to identify incident fibroids from electronic data.
This study aims to evaluate the effects of low-dose estradiol (E2) or venlafaxine on menopause-re... more This study aims to evaluate the effects of low-dose estradiol (E2) or venlafaxine on menopause-related quality of life and associated symptoms in healthy perimenopausal and postmenopausal women with hot flashes. A double-blind, placebo-controlled, randomized trial of low-dose oral 17β-E2 0.5 mg/day and venlafaxine XR 75 mg/day, versus identical placebo, was conducted among 339 women (aged 40-62 y) experiencing two or more vasomotor symptoms (VMS) per day (mean [SD], 8.07 [5.29]) who were recruited at three clinical sites from November 2011 to October 2012. The primary trial outcome, as reported previously, was frequency of VMS at 8 weeks. Here, we report on secondary endpoints of total and domain scores from the Menopause-Specific Quality of Life Questionnaire (MENQOL) and from measures of pain (Pain, Enjoyment in life, and General activity scale), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder Questionnaire-7), and perceived stress (Perceived Str...
Objective-To evaluate whether an Obstetrics-Gynecology clinic-based collaborative depression care... more Objective-To evaluate whether an Obstetrics-Gynecology clinic-based collaborative depression care intervention is differentially effective compared to Usual Care for socially disadvantaged women with either no health insurance or public coverage compared to those with commercial insurance. Methods-A two-site randomized, controlled trial with 18-month follow-up recruited women who screened positive (PHQ-9 ≥10) and met criteria for major depression and/or dysthymia. We tested whether insurance status modified Intervention versus Usual Care continuous depression outcomes over 18 months. We also describe Intervention versus Usual Care differences in quality of depression care and dichotomous clinical outcomes (≥ 50% decrease in depressive symptoms and Patient Global Improvement). Results-There was a significant modification of the treatment effect by insurance status (p=0.05). Patients in the no insurance or public coverage group had greater recovery from depression symptoms with collaborative care versus Usual Care over the 18-month follow-up period compared to the commercial insurance group. At 12-month follow-up, women in the no insurance or public coverage group had an effect-size for depression improvement versus Usual Care of 0.81 (95% CI 0.41, 0.95), whereas women with commercial insurance had an effect size for Intervention versus Usual Care of 0.39 (95% CI-0.08, 0.84).
American Journal of Obstetrics and Gynecology, 2007
The objective of the study was to evaluate the association of depression, sleep disturbance, and ... more The objective of the study was to evaluate the association of depression, sleep disturbance, and menopausal symptoms with diminished libido. STUDY DESIGN: Data from a 2001-2002 baseline survey of 341 peri-and postmenopausal women, aged 45-55 years, participating in a randomized trial, was analyzed. Eligibility included at least 2 hot flashes and/or night sweats per day and no hormone therapy for at least the prior 3 months. The survey evaluated sexual function, depression, sleep, and vasomotor symptoms. We examined the association between these factors, using multivariate regression models. RESULTS: Of 341 women, 64% had diminished libido, 18% had moderate to severe depression, and 43% had poor sleep quality. Women averaged 4.6 hot flashes and 1.9 night sweats per day. Depressive symptoms (P ϭ .003), poor sleep (P ϭ .02), and night sweats (P ϭ .04) were significantly associated with diminished libido. CONCLUSION: Factors associated with diminished libido in midlife are complex but include depression, disturbed sleep, and night sweats, all common symptoms of the menopausal transition and early menopause.
Background-Behavioral strategies are recommended for menopausal symptoms, but little evidence exi... more Background-Behavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy.
Objective: To validate algorithms identifying uterine perforations and intrauterine device (IUD) ... more 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.
American journal of obstetrics and gynecology, Jan 16, 2015
Impaired physician performance from sleep deprivation has been linked to serious medical errors. ... more Impaired physician performance from sleep deprivation has been linked to serious medical errors. In 2003, resident work rules were enacted to limit hospital work hours with the goal of improved patient safety. Since then, resident inhouse call has decreased and home call has increased, despite little understanding of the impact of home call on sleep disruption and patient care. We evaluated home-call sleep patterns in an obstetrics and gynecology residency program. STUDY DESIGN: Obstetrics and gynecology residents (N ¼ 14) were enrolled in a crossover study. On each of 3 separate weekends of home call, no call, or in-house call the resident wore an actigraph sleep monitor (Actiwatch Model AW64, Minimitter, Sun River, OR) and completed a sleep log (selfreported hours slept, sleep satisfaction, sleep quality, and awakening alertness). The daily sleep logs and actigraphy data for the 3 weekend types were compared using paired t tests (primary comparison groups home call vs no call). The study was powered to detect a difference of at least 0.66 hours per night between groups in total actigraphyrecorded hours slept each weekend.
American Journal of Obstetrics and Gynecology, 2005
Pregnancy complications Birth outcomes Somali Female circumcision Culture Objective: The purpose ... more Pregnancy complications Birth outcomes Somali Female circumcision Culture Objective: The purpose of this study was to compare maternal and neonatal morbidity among Somali immigrants, US-born blacks and whites in Washington state. Study design: Washington state birth certificate data was linked to hospital discharge records comparing singleton deliveries among Somali immigrants with US-born blacks and whites between 1993 and 2001, in a 1:3 ratio. Outcomes were compared using unconditional multiple logistic regression models calculating odds ratios (ORs), and 95% confidence intervals (95% CIs). Results: Five hundred seventy-nine pregnancies from Somali women were compared with 2384 and 2435 pregnancies from black and white women, respectively. Nulliparous Somali women were more likely to have a cesarean delivery than black or white control women, OR 1.6 (95% CI, 1.1-2.3) and 2.0 (95% CI, 1.4-2.8), respectively. Among all women who had cesarean deliveries, Somali women more commonly had cesarean deliveries associated with fetal distress and failed induction of labor. They were 9 times more likely than both control groups to deliver after 42 weeks gestation, and 4 times more likely than black women and 8 times more likely than white women to have oligohydramnios. Somali women were more likely to have gestational diabetes and significant perineal lacerations, and less likely to smoke. Newborns of Somali women were at increased risk for prolonged hospitalization, lower 5-minute Apgar scores, assisted ventilation, and meconium aspiration. Conclusion: Pregnancy outcomes should be evaluated within ethnically and culturally unique groups; Somali immigrants are a high-risk subpopulation.
Background: Careful management of symptoms, particularly sleep and mood disturbances, may assist ... more Background: Careful management of symptoms, particularly sleep and mood disturbances, may assist women in discontinuing hormone therapy (HT). We sought to describe characteristics associated with successful HT cessation in women who attempted to discontinue estrogen pills/patches with or without progestin. Methods: We invited 2,328 women, aged 45-70, enrolled January 1, 2005, to May 31, 2006, at Group Health in Washington State and Harvard Vanguard Medical Associates in Massachusetts, to participate in a telephone survey about HT practices. For the sample, we selected 2,090 women with estrogen dispensings (pharmacy data) during the study period, 200 women without HT dispensing after January 2005, and 240 women with no estrogen dispensings; 1,358 (58.3%) completed the survey. These analyses are based on survey responses. Results: Among 802 women who attempted HT discontinuation, the mean age was 50 years, 93% were postmenopausal, 90% were white, 30% had had a hysterectomy, and 75% experienced hot flashes after discontinuation. Those who did not succeed had greater trouble sleeping (74% vs. 57%) and mood disturbances (51% vs. 34%) than those who succeeded. In multivariable analyses, factors associated with successful discontinuation included doctor advice (odds ratio [OR] 2.62, 95% confidence interval [CI] 1.68-4.08), lack of symptom improvement (OR 4.21, CI 1.50-12.17), vaginal bleeding (OR 5.96, CI 1.44-24.6), and learning to cope with symptoms (OR 3.36, CI 2.21-5.11). Factors associated with unsuccessful HT discontinuation included trouble sleeping (OR 0.40, CI 0.26-0.61) and mood swings or depression (OR 0.63, CI 0.42-0.92). Conclusions: Doctor advice is strongly associated with successful HT discontinuation. Symptom management, particularly sleep and mood disturbances, may help women discontinue HT.
Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on ... more Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms. A total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 μg estradiol tablet plus placebo gel (n = 102), vaginal moisturizer plus placebo tablet (n = 100), or dual placebo (n = 100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. Treatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms -0.3 at 12 weeks (95% confidence...
Mental health care integrated into obstetric settings improves access to perinatal depression tre... more Mental health care integrated into obstetric settings improves access to perinatal depression treatments. Digital interactions such as text messaging between patient and provider can further improve access. We describe the use of text messaging within a perinatal Collaborative Care (CC) program, and explore the association of text messaging content with perinatal depression outcomes. We analyzed data from an open treatment trial of perinatal CC in a rural obstetric clinic. Twenty five women with Patient Health Questionnaire-9 score of ≥10 enrolled in CC, and used text messaging to communicate with their Care Manager(CM). We used surveys and focus groups to assessacceptability of text messaging with surveys and focus groups. We calculated the number of text messages exchanged, and analyzed content to understand usage patterns. We explored association between text messaging content and depression outcomes. CMs initiated 85.4% messages, and patients responded to 86.9% messages. CMs use...
Women are at a higher risk for depression than are men, and this risk is especially pronounced at... more Women are at a higher risk for depression than are men, and this risk is especially pronounced at specific reproductive periods of vulnerability: adolescence, pregnancy, postpartum,, and the menopausal transition. Obstetrician-gynecologists are often the health care providers that women consult during these vulnerable periods, usually presenting with conditions or complaints other than depression or anxiety. Presenting symptoms are frequently known comorbidities with depression, or are risk factors for depression. Thus, by screening for depression and other mood disorders in these critical periods, in addition to screening at routine intervals such as annual examinations, obstetricians and gynecologists can play an important role in early detection, prevention, and treatment of mood disorders and their comorbid conditions. We provide a framework for depression management within busy obstetric gynecology settings using new integrated care models for mental health. Precis Obstetrician-gynecologists should screen and treat women for depression during routine prevention visits and at vulnerable reproductive stages; new integrated care models are recommended.
Objectives: Hormone Replacement Therapy (HRT) has been associated with an increased risk of breas... more Objectives: Hormone Replacement Therapy (HRT) has been associated with an increased risk of breast cancer (BC). The study objective was to evaluate whether the increased risk is dependent on the formulation used. Study Methods: We conducted a population-based case-control study using data from the United Kingdom Clinical Practice Research Datalink on women aged >50. Cases of newly diagnosed BC were agematched (1:10) with women of comparable follow-up time with no history of BC. Exposures were classified as ever/never for the following HRT formulations: Bioidentical Estrogens (BE), Conjugated Equine Estrogens (CEE), Micronized Progesterone (MP), and Synthetic Progestogens (SP). Logistic regression estimated the adjusted effect of HRT formulation on BC Results: Between 1995 and 2014, 43,183 cases of BC were identified and matched to 431,830 controls. Cases were more likely to be smokers and obese. In adjusted analyses, compared with women who never used HRT, HRT use was associated with an overall increased risk of BC (OR 1.12(1.09-1.15). As compared with never users, estrogens were not associated with BC: BE (OR 1.
To identify risk factors associated with contraceptive nonuse among obese women. Methods: We perf... more To identify risk factors associated with contraceptive nonuse among obese women. Methods: We performed a case control study of sexually active, obese women (body mass index > 30), aged 20 to 44 years, at risk of unintended pregnancy using the 2006-2010 National Survey of Family Growth. We defined cases as contraceptive nonusers and controls as users of any contraceptive method. We assessed demographic, reproductive, behavioral, and health services factors associated with nonuse using generalized linear models with a log-link function to estimate relative risks and 95% confidence intervals (CI). Results: Of 1,359 obese respondents at risk of unintended pregnancy, 21.4% were nonusers (n=292). In our multivariable model, nonusers users compared to users were more likely to be between the ages 35 to 39 years (aRR 1.65, 95%CI 1.05-2.59), non-Hispanic black (aRR 1.43, 95%CI 1.03-2.00), single (1.44, 95%CI 1.04-2.00), parous with 1 prior birth (aRR 1.52, 95%CI 1.07-2.15) or 2 births (aRR 1.57, 95%CI 1.10-2.23); to have infrequent sex (aRR 1.67, 95%CI 1.27-2.22); and to perceive difficulty becoming pregnant (aRR 1.89, > 95%CI 1.42-2.53). Obese nonusers did not differ significantly from users in socioeconomic indicators. Compared to users, nonusers were less likely to have discussed contraception with a health care provider (OR 0.45, 95%CI 0.31-0.65). Conclusions: Efforts to decrease contraceptive nonuse among obese women should focus on older, non-Hispanic black, single, parous women across all socioeconomic strata. Increasing contraceptive counseling by providers may improve contraceptive uptake, especially among obese women who have infrequent sex and who perceive difficulty becoming pregnant.
Background-Women have higher rates of depression and often experience depression symptoms during ... more Background-Women have higher rates of depression and often experience depression symptoms during critical reproductive periods, including adolescence, pregnancy, postpartum, and menopause. Collaborative care intervention models for mood disorders in patients receiving care in an OB-GYN clinic setting have not been evaluated. Study design and methodology for a randomized, controlled trial of collaborative care depression management versus usual care in OB-GYN clinics and the details of the adapted collaborative care intervention and model implementation are described in this paper. Methods-Women over age 18 years with clinically significant symptoms of depression, as measured by a Patient Health Questionnaire-9 (PHQ-9) score ≥10 and a clinical diagnosis of major depression or dysthymia, were randomized to the study intervention or to usual care and were followed for 18 months. The primary outcome assessed was change over time in the SCL-20 depression scale between baseline and 12 months. Baseline Results-205 women were randomized: 57% white, 20% African American, 9% Asian or Pacific Islander, 7% Hispanic, and 6% Native American. Mean age was 39 years. 4.6% were pregnant and 7.5% were within 12 months postpartum. The majority were single, (52%), and 95% had at least the equivalent of a high school diploma. Almost all patients met DSM IV criteria for major depression (99%) and approximately 33% met criteria for dysthymia. Conclusions-An OB-GYN collaborative care team including a social worker, psychiatrist and OB-GYN physician who met weekly and used an electronic tracking system for patients were essential elements of the proposed depression care treatment model described here. Further study of models that improve quality of depression care that are adapted to the unique OB-GYN setting are needed.
Objective-Postmenopausal hot flash etiology is poorly understood, making it difficult to develop ... more Objective-Postmenopausal hot flash etiology is poorly understood, making it difficult to develop and target ideal therapies. A network of hypothalamic estrogen-sensitive neurons producing Kisspeptin, Neurokinin B, and Dynorphin (KNDy neurons), located adjacent to the thermoregulatory center, regulate pulsatile secretion of GnRH and LH. Dynorphin may inhibit this system by binding kappa opioid receptors within the vicinity of KNDy neurons. We hypothesize that hot flashes are reduced by KNDy neuron manipulation. Methods-A double-blind, cross-over, placebo-controlled pilot study evaluated the effect of a kappa agonist (KA).Hot flash frequency was the primary outcome. Twelve healthy postmenopausal women with moderate-severe hot flashes, ages 48-60 years, were randomized. Eight women with sufficient baseline hot flashes for statistical analysis completed all 3 interventions: placebo, standard Pentazocine/Naloxone (50/0.5 mg) or low-dose Pentazocine/ Naloxone (25/0.25 mg). In an inpatient research setting, each participant received the 3 interventions, in randomized order, on 3 separate days. On each day, an intravenous catheter was inserted for luteinizing hormone (LH) blood sampling, and skin conductance and Holter monitors were placed. Subjective hot flash frequency and severity were recorded. Results-Mean hot flash frequency 2-7 hours following therapy initiation was lower than that for placebo (KA standard-dose: 4.75 ± 0.67; KA low-dose: 4.50 ± 0.57; and placebo: 5.94 ± 0.78 hot flashes/5 hours; p =0.025). Hot flash intensity did not vary between interventions. LH pulsatility mirrored objective hot flashes in some, but not all women. Conclusions-This pilot suggests that kappa agonists may affect menopausal vasomotor symptoms.
The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three... more The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions' effects relative to control in women with comparably severe insomnia symptoms and VMS. We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ≥ 12, and ≥14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10-20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8-12 weeks of treatment. CBT-I produced the greatest reduction...
IMPORTANCE Intrauterine device (IUD) expulsion increases the risk of unintended pregnancy; how ti... more 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, (continued) Key Points Question Are timing of intrauterine device (IUD) insertion post partum and breastfeeding associated with the risk of IUD expulsion? Findings In this cohort study of 326 658 women, 5-year cumulative incidence of IUD expulsion was highest among women with postpartum IUD insertions at 0 to 3 days and lowest for those with insertions at more than 6 weeks to 14 or fewer weeks. IUD expulsion was higher for women who were not breastfeeding. Meaning In this study, immediate postpartum IUD insertion was associated with increased risk of IUD expulsion relative to later insertions, and breastfeeding was associated with lower expulsion risk.
Journal of Patient-Centered Research and Reviews, 2017
Introduction: Uterine fibroids are the most common benign tumors of the uterus and are associated... more Introduction: Uterine fibroids are the most common benign tumors of the uterus and are associated with considerable morbidity. Diagnosis codes have been used to identify fibroid cases, but their accuracy, especially for incident cases, is uncertain. Methods: We performed medical record review on a random sample of 617 women who received a fibroid diagnosis during 2012-2014 to assess diagnostic accuracy for incident fibroids. We developed 2 algorithms aimed at improving incident case-finding using classification and regression tree analysis that incorporated additional electronic health care data on demographics, symptoms, treatment, imaging, health care utilization, comorbidities and medication. Algorithm performance was assessed using medical record as gold standard. Results: Medical record review confirmed 482 fibroid cases as incident, resulting a 78 percent positive predictive value (PPV) for incident cases based on diagnosis codes alone. Incorporating additional electronic data, the first algorithm classified 395 women with a pelvic ultrasound on diagnosis date but none before as incident cases. Of these, 344 were correctly classified, yielding an 87 percent PPV, 71 percent sensitivity, and 62 percent specificity. A second algorithm built on the first algorithm and further classified women based on a fibroid diagnosis code of 218.9 in 2 years after incident diagnosis and lower body mass index; yielded 93 percent PPV, 53 percent sensitivity, and 85 percent specificity. Conclusions: Compared to diagnosis codes alone, our algorithms using fibroid diagnosis codes and additional electronic data improved identification of incident cases with higher PPV, and high sensitivity or specificity to meet different aims of future studies seeking to identify incident fibroids from electronic data.
This study aims to evaluate the effects of low-dose estradiol (E2) or venlafaxine on menopause-re... more This study aims to evaluate the effects of low-dose estradiol (E2) or venlafaxine on menopause-related quality of life and associated symptoms in healthy perimenopausal and postmenopausal women with hot flashes. A double-blind, placebo-controlled, randomized trial of low-dose oral 17β-E2 0.5 mg/day and venlafaxine XR 75 mg/day, versus identical placebo, was conducted among 339 women (aged 40-62 y) experiencing two or more vasomotor symptoms (VMS) per day (mean [SD], 8.07 [5.29]) who were recruited at three clinical sites from November 2011 to October 2012. The primary trial outcome, as reported previously, was frequency of VMS at 8 weeks. Here, we report on secondary endpoints of total and domain scores from the Menopause-Specific Quality of Life Questionnaire (MENQOL) and from measures of pain (Pain, Enjoyment in life, and General activity scale), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder Questionnaire-7), and perceived stress (Perceived Str...
Objective-To evaluate whether an Obstetrics-Gynecology clinic-based collaborative depression care... more Objective-To evaluate whether an Obstetrics-Gynecology clinic-based collaborative depression care intervention is differentially effective compared to Usual Care for socially disadvantaged women with either no health insurance or public coverage compared to those with commercial insurance. Methods-A two-site randomized, controlled trial with 18-month follow-up recruited women who screened positive (PHQ-9 ≥10) and met criteria for major depression and/or dysthymia. We tested whether insurance status modified Intervention versus Usual Care continuous depression outcomes over 18 months. We also describe Intervention versus Usual Care differences in quality of depression care and dichotomous clinical outcomes (≥ 50% decrease in depressive symptoms and Patient Global Improvement). Results-There was a significant modification of the treatment effect by insurance status (p=0.05). Patients in the no insurance or public coverage group had greater recovery from depression symptoms with collaborative care versus Usual Care over the 18-month follow-up period compared to the commercial insurance group. At 12-month follow-up, women in the no insurance or public coverage group had an effect-size for depression improvement versus Usual Care of 0.81 (95% CI 0.41, 0.95), whereas women with commercial insurance had an effect size for Intervention versus Usual Care of 0.39 (95% CI-0.08, 0.84).
American Journal of Obstetrics and Gynecology, 2007
The objective of the study was to evaluate the association of depression, sleep disturbance, and ... more The objective of the study was to evaluate the association of depression, sleep disturbance, and menopausal symptoms with diminished libido. STUDY DESIGN: Data from a 2001-2002 baseline survey of 341 peri-and postmenopausal women, aged 45-55 years, participating in a randomized trial, was analyzed. Eligibility included at least 2 hot flashes and/or night sweats per day and no hormone therapy for at least the prior 3 months. The survey evaluated sexual function, depression, sleep, and vasomotor symptoms. We examined the association between these factors, using multivariate regression models. RESULTS: Of 341 women, 64% had diminished libido, 18% had moderate to severe depression, and 43% had poor sleep quality. Women averaged 4.6 hot flashes and 1.9 night sweats per day. Depressive symptoms (P ϭ .003), poor sleep (P ϭ .02), and night sweats (P ϭ .04) were significantly associated with diminished libido. CONCLUSION: Factors associated with diminished libido in midlife are complex but include depression, disturbed sleep, and night sweats, all common symptoms of the menopausal transition and early menopause.
Background-Behavioral strategies are recommended for menopausal symptoms, but little evidence exi... more Background-Behavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy.
Objective: To validate algorithms identifying uterine perforations and intrauterine device (IUD) ... more 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.
American journal of obstetrics and gynecology, Jan 16, 2015
Impaired physician performance from sleep deprivation has been linked to serious medical errors. ... more Impaired physician performance from sleep deprivation has been linked to serious medical errors. In 2003, resident work rules were enacted to limit hospital work hours with the goal of improved patient safety. Since then, resident inhouse call has decreased and home call has increased, despite little understanding of the impact of home call on sleep disruption and patient care. We evaluated home-call sleep patterns in an obstetrics and gynecology residency program. STUDY DESIGN: Obstetrics and gynecology residents (N ¼ 14) were enrolled in a crossover study. On each of 3 separate weekends of home call, no call, or in-house call the resident wore an actigraph sleep monitor (Actiwatch Model AW64, Minimitter, Sun River, OR) and completed a sleep log (selfreported hours slept, sleep satisfaction, sleep quality, and awakening alertness). The daily sleep logs and actigraphy data for the 3 weekend types were compared using paired t tests (primary comparison groups home call vs no call). The study was powered to detect a difference of at least 0.66 hours per night between groups in total actigraphyrecorded hours slept each weekend.
American Journal of Obstetrics and Gynecology, 2005
Pregnancy complications Birth outcomes Somali Female circumcision Culture Objective: The purpose ... more Pregnancy complications Birth outcomes Somali Female circumcision Culture Objective: The purpose of this study was to compare maternal and neonatal morbidity among Somali immigrants, US-born blacks and whites in Washington state. Study design: Washington state birth certificate data was linked to hospital discharge records comparing singleton deliveries among Somali immigrants with US-born blacks and whites between 1993 and 2001, in a 1:3 ratio. Outcomes were compared using unconditional multiple logistic regression models calculating odds ratios (ORs), and 95% confidence intervals (95% CIs). Results: Five hundred seventy-nine pregnancies from Somali women were compared with 2384 and 2435 pregnancies from black and white women, respectively. Nulliparous Somali women were more likely to have a cesarean delivery than black or white control women, OR 1.6 (95% CI, 1.1-2.3) and 2.0 (95% CI, 1.4-2.8), respectively. Among all women who had cesarean deliveries, Somali women more commonly had cesarean deliveries associated with fetal distress and failed induction of labor. They were 9 times more likely than both control groups to deliver after 42 weeks gestation, and 4 times more likely than black women and 8 times more likely than white women to have oligohydramnios. Somali women were more likely to have gestational diabetes and significant perineal lacerations, and less likely to smoke. Newborns of Somali women were at increased risk for prolonged hospitalization, lower 5-minute Apgar scores, assisted ventilation, and meconium aspiration. Conclusion: Pregnancy outcomes should be evaluated within ethnically and culturally unique groups; Somali immigrants are a high-risk subpopulation.
Background: Careful management of symptoms, particularly sleep and mood disturbances, may assist ... more Background: Careful management of symptoms, particularly sleep and mood disturbances, may assist women in discontinuing hormone therapy (HT). We sought to describe characteristics associated with successful HT cessation in women who attempted to discontinue estrogen pills/patches with or without progestin. Methods: We invited 2,328 women, aged 45-70, enrolled January 1, 2005, to May 31, 2006, at Group Health in Washington State and Harvard Vanguard Medical Associates in Massachusetts, to participate in a telephone survey about HT practices. For the sample, we selected 2,090 women with estrogen dispensings (pharmacy data) during the study period, 200 women without HT dispensing after January 2005, and 240 women with no estrogen dispensings; 1,358 (58.3%) completed the survey. These analyses are based on survey responses. Results: Among 802 women who attempted HT discontinuation, the mean age was 50 years, 93% were postmenopausal, 90% were white, 30% had had a hysterectomy, and 75% experienced hot flashes after discontinuation. Those who did not succeed had greater trouble sleeping (74% vs. 57%) and mood disturbances (51% vs. 34%) than those who succeeded. In multivariable analyses, factors associated with successful discontinuation included doctor advice (odds ratio [OR] 2.62, 95% confidence interval [CI] 1.68-4.08), lack of symptom improvement (OR 4.21, CI 1.50-12.17), vaginal bleeding (OR 5.96, CI 1.44-24.6), and learning to cope with symptoms (OR 3.36, CI 2.21-5.11). Factors associated with unsuccessful HT discontinuation included trouble sleeping (OR 0.40, CI 0.26-0.61) and mood swings or depression (OR 0.63, CI 0.42-0.92). Conclusions: Doctor advice is strongly associated with successful HT discontinuation. Symptom management, particularly sleep and mood disturbances, may help women discontinue HT.
Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on ... more Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms. A total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 μg estradiol tablet plus placebo gel (n = 102), vaginal moisturizer plus placebo tablet (n = 100), or dual placebo (n = 100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. Treatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms -0.3 at 12 weeks (95% confidence...
Mental health care integrated into obstetric settings improves access to perinatal depression tre... more Mental health care integrated into obstetric settings improves access to perinatal depression treatments. Digital interactions such as text messaging between patient and provider can further improve access. We describe the use of text messaging within a perinatal Collaborative Care (CC) program, and explore the association of text messaging content with perinatal depression outcomes. We analyzed data from an open treatment trial of perinatal CC in a rural obstetric clinic. Twenty five women with Patient Health Questionnaire-9 score of ≥10 enrolled in CC, and used text messaging to communicate with their Care Manager(CM). We used surveys and focus groups to assessacceptability of text messaging with surveys and focus groups. We calculated the number of text messages exchanged, and analyzed content to understand usage patterns. We explored association between text messaging content and depression outcomes. CMs initiated 85.4% messages, and patients responded to 86.9% messages. CMs use...
Women are at a higher risk for depression than are men, and this risk is especially pronounced at... more Women are at a higher risk for depression than are men, and this risk is especially pronounced at specific reproductive periods of vulnerability: adolescence, pregnancy, postpartum,, and the menopausal transition. Obstetrician-gynecologists are often the health care providers that women consult during these vulnerable periods, usually presenting with conditions or complaints other than depression or anxiety. Presenting symptoms are frequently known comorbidities with depression, or are risk factors for depression. Thus, by screening for depression and other mood disorders in these critical periods, in addition to screening at routine intervals such as annual examinations, obstetricians and gynecologists can play an important role in early detection, prevention, and treatment of mood disorders and their comorbid conditions. We provide a framework for depression management within busy obstetric gynecology settings using new integrated care models for mental health. Precis Obstetrician-gynecologists should screen and treat women for depression during routine prevention visits and at vulnerable reproductive stages; new integrated care models are recommended.
Objectives: Hormone Replacement Therapy (HRT) has been associated with an increased risk of breas... more Objectives: Hormone Replacement Therapy (HRT) has been associated with an increased risk of breast cancer (BC). The study objective was to evaluate whether the increased risk is dependent on the formulation used. Study Methods: We conducted a population-based case-control study using data from the United Kingdom Clinical Practice Research Datalink on women aged >50. Cases of newly diagnosed BC were agematched (1:10) with women of comparable follow-up time with no history of BC. Exposures were classified as ever/never for the following HRT formulations: Bioidentical Estrogens (BE), Conjugated Equine Estrogens (CEE), Micronized Progesterone (MP), and Synthetic Progestogens (SP). Logistic regression estimated the adjusted effect of HRT formulation on BC Results: Between 1995 and 2014, 43,183 cases of BC were identified and matched to 431,830 controls. Cases were more likely to be smokers and obese. In adjusted analyses, compared with women who never used HRT, HRT use was associated with an overall increased risk of BC (OR 1.12(1.09-1.15). As compared with never users, estrogens were not associated with BC: BE (OR 1.
To identify risk factors associated with contraceptive nonuse among obese women. Methods: We perf... more To identify risk factors associated with contraceptive nonuse among obese women. Methods: We performed a case control study of sexually active, obese women (body mass index > 30), aged 20 to 44 years, at risk of unintended pregnancy using the 2006-2010 National Survey of Family Growth. We defined cases as contraceptive nonusers and controls as users of any contraceptive method. We assessed demographic, reproductive, behavioral, and health services factors associated with nonuse using generalized linear models with a log-link function to estimate relative risks and 95% confidence intervals (CI). Results: Of 1,359 obese respondents at risk of unintended pregnancy, 21.4% were nonusers (n=292). In our multivariable model, nonusers users compared to users were more likely to be between the ages 35 to 39 years (aRR 1.65, 95%CI 1.05-2.59), non-Hispanic black (aRR 1.43, 95%CI 1.03-2.00), single (1.44, 95%CI 1.04-2.00), parous with 1 prior birth (aRR 1.52, 95%CI 1.07-2.15) or 2 births (aRR 1.57, 95%CI 1.10-2.23); to have infrequent sex (aRR 1.67, 95%CI 1.27-2.22); and to perceive difficulty becoming pregnant (aRR 1.89, > 95%CI 1.42-2.53). Obese nonusers did not differ significantly from users in socioeconomic indicators. Compared to users, nonusers were less likely to have discussed contraception with a health care provider (OR 0.45, 95%CI 0.31-0.65). Conclusions: Efforts to decrease contraceptive nonuse among obese women should focus on older, non-Hispanic black, single, parous women across all socioeconomic strata. Increasing contraceptive counseling by providers may improve contraceptive uptake, especially among obese women who have infrequent sex and who perceive difficulty becoming pregnant.
Background-Women have higher rates of depression and often experience depression symptoms during ... more Background-Women have higher rates of depression and often experience depression symptoms during critical reproductive periods, including adolescence, pregnancy, postpartum, and menopause. Collaborative care intervention models for mood disorders in patients receiving care in an OB-GYN clinic setting have not been evaluated. Study design and methodology for a randomized, controlled trial of collaborative care depression management versus usual care in OB-GYN clinics and the details of the adapted collaborative care intervention and model implementation are described in this paper. Methods-Women over age 18 years with clinically significant symptoms of depression, as measured by a Patient Health Questionnaire-9 (PHQ-9) score ≥10 and a clinical diagnosis of major depression or dysthymia, were randomized to the study intervention or to usual care and were followed for 18 months. The primary outcome assessed was change over time in the SCL-20 depression scale between baseline and 12 months. Baseline Results-205 women were randomized: 57% white, 20% African American, 9% Asian or Pacific Islander, 7% Hispanic, and 6% Native American. Mean age was 39 years. 4.6% were pregnant and 7.5% were within 12 months postpartum. The majority were single, (52%), and 95% had at least the equivalent of a high school diploma. Almost all patients met DSM IV criteria for major depression (99%) and approximately 33% met criteria for dysthymia. Conclusions-An OB-GYN collaborative care team including a social worker, psychiatrist and OB-GYN physician who met weekly and used an electronic tracking system for patients were essential elements of the proposed depression care treatment model described here. Further study of models that improve quality of depression care that are adapted to the unique OB-GYN setting are needed.
Objective-Postmenopausal hot flash etiology is poorly understood, making it difficult to develop ... more Objective-Postmenopausal hot flash etiology is poorly understood, making it difficult to develop and target ideal therapies. A network of hypothalamic estrogen-sensitive neurons producing Kisspeptin, Neurokinin B, and Dynorphin (KNDy neurons), located adjacent to the thermoregulatory center, regulate pulsatile secretion of GnRH and LH. Dynorphin may inhibit this system by binding kappa opioid receptors within the vicinity of KNDy neurons. We hypothesize that hot flashes are reduced by KNDy neuron manipulation. Methods-A double-blind, cross-over, placebo-controlled pilot study evaluated the effect of a kappa agonist (KA).Hot flash frequency was the primary outcome. Twelve healthy postmenopausal women with moderate-severe hot flashes, ages 48-60 years, were randomized. Eight women with sufficient baseline hot flashes for statistical analysis completed all 3 interventions: placebo, standard Pentazocine/Naloxone (50/0.5 mg) or low-dose Pentazocine/ Naloxone (25/0.25 mg). In an inpatient research setting, each participant received the 3 interventions, in randomized order, on 3 separate days. On each day, an intravenous catheter was inserted for luteinizing hormone (LH) blood sampling, and skin conductance and Holter monitors were placed. Subjective hot flash frequency and severity were recorded. Results-Mean hot flash frequency 2-7 hours following therapy initiation was lower than that for placebo (KA standard-dose: 4.75 ± 0.67; KA low-dose: 4.50 ± 0.57; and placebo: 5.94 ± 0.78 hot flashes/5 hours; p =0.025). Hot flash intensity did not vary between interventions. LH pulsatility mirrored objective hot flashes in some, but not all women. Conclusions-This pilot suggests that kappa agonists may affect menopausal vasomotor symptoms.
The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three... more The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions' effects relative to control in women with comparably severe insomnia symptoms and VMS. We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ≥ 12, and ≥14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10-20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8-12 weeks of treatment. CBT-I produced the greatest reduction...
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