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.

Digital Mammography and Breast Tomosynthesis Performance in Women with a Personal History of Breast Cancer, 2007-2016.

Background Since 2007, digital mammography and digital breast tomosynthesis (DBT) replaced screen-film mammography. Whether these technologic advances have improved diagnostic performance has, to the knowledge of the authors, not yet been established. Purpose To evaluate the performance and outcomes of surveillance mammography (digital mammography and DBT) performed from 2007 to 2016 in women with a personal history of breast cancer and compare with data from 1996 to 2007 and the performance of digital mammography screening benchmarks. Materials and Methods In this observational cohort study, five Breast Cancer Surveillance Consortium registries provided prospectively collected mammography data linked with tumor registry and pathologic outcomes. This study identified asymptomatic women with American Joint Committee on Cancer anatomic stages 0-III primary breast cancer who underwent surveillance mammography from 2007 to 2016. The primary outcome was a second breast cancer diagnosis within 1 year of mammography. Performance measures included the recall rate, cancer detection rate, interval cancer rate, positive predictive value of biopsy recommendation, sensitivity, and specificity. Results Among 32 331 women who underwent 117 971 surveillance mammographic examinations (112 269 digital mammographic examinations and 5702 DBT examinations), the mean age at initial diagnosis was 59 years ± 12 (standard deviation). Of 1418 second breast cancers diagnosed, 998 were surveillance-detected cancers and 420 were interval cancers. The recall rate was 8.8% (10 365 of 117 971; 95% CI: 8.6%, 9.0%), the cancer detection rate was 8.5 per 1000 examinations (998 of 117 971; 95% CI: 8.0, 9.0), the interval cancer rate was 3.6 per 1000 examinations (420 of 117 971; 95% CI: 3.2, 3.9), the positive predictive value of biopsy recommendation was 31.0% (998 of 3220; 95% CI: 29.4%, 32.7%), the sensitivity was 70.4% (998 of 1418; 95% CI: 67.9%, 72.7%), and the specificity was 98.1% (114 331 of 116 553; 95% CI: 98.0%, 98.2%). Compared with previously published studies, interval cancer rate was comparable with rates from 1996 to 2007 in women with a personal history of breast cancer and was higher than the published digital mammography screening benchmarks. Conclusion In transitioning from screen-film to digital mammography and digital breast tomosynthesis, surveillance mammography performance demonstrated minimal improvement over time and remained inferior to the performance of screening mammography benchmarks. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Moy and Gao in this issue.

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.

Trends in breast biopsy pathology diagnoses among women undergoing mammography in the United States: a report from the Breast Cancer Surveillance Consortium.

BACKGROUND: Current data on the pathologic diagnoses of breast biopsy after mammography can inform patients, clinicians, and researchers about important population trends. METHODS: Breast Cancer Surveillance Consortium data on 4,020,140 mammograms between 1996 and 2008 were linked to 76,567 pathology specimens. Trends in diagnoses in biopsies by time and risk factors (patient age, breast density, and family history of breast cancer) were examined for screening and diagnostic mammography (performed for a breast symptom or short-interval follow-up). RESULTS: Of the total mammograms, 88.5% were screening and 11.5% diagnostic; 1.2% of screening and 6.8% of diagnostic mammograms were followed by biopsies. The frequency of biopsies over time was stable after screening mammograms, but increased after diagnostic mammograms. For biopsies obtained after screening, frequencies of invasive carcinoma increased over time for women ages 40-49 and 60-69, Ductal carcinoma in situ (DCIS) increased for those ages 40-69, whereas benign diagnoses decreased for all ages. No trends in pathology diagnoses were found following diagnostic mammograms. Dense breast tissue was associated with high-risk lesions and DCIS relative to nondense breast tissue. Family history of breast cancer was associated with DCIS and invasive cancer. CONCLUSIONS: Although the frequency of breast biopsy after screening mammography has not changed over time, the percentages of biopsies with DCIS and invasive cancer diagnoses have increased. Among biopsies following mammography, women with dense breasts or family history of breast cancer were more likely to have high-risk lesions or invasive cancer. These findings are relevant to breast cancer screening and diagnostic practices.

SARS-CoV-2 Infection and Related Hospitalization among Cancer Survivors.

BACKGROUND: Little is known about SARS-CoV-2 infection and COVID-19 severity among a growing population of cancer survivors. We describe the association of infection and related hospitalization by recency of cancer diagnosis in a large U.S. cohort. METHODS: Participants were sent electronic surveys between April 2020 and January 2021 to collect information on SARS-CoV-2 infection and potential COVID-19-related risk factors. SARS-CoV-2 infections were identified using survey report of a COVID-19-positive test and electronic health record data. Cumulative incidence of SARS-CoV-2 infection was estimated up to 365 days from baseline survey and stratified by recency of cancer diagnosis. Among those with SARS-CoV-2 infection, we used logistic regression to estimate the association between recency of cancer diagnosis and hospitalization within 30 days of infection. RESULTS: Cumulative incidence of SARS-CoV-2 infection at 365 days was 3.3% [95% confidence interval (CI), 3.2%-3.5%] among those without cancer history and ranged from 2.8% (95% CI, 2.3%-3.5%) to 3.7% (95% CI, 2.9%-4.7%) among those with a history of cancer depending on recency. There was no statistically significant difference in odds of hospitalization within 30 days following SARS-CoV-2 infection by cancer diagnosis recency. CONCLUSIONS: Our null findings are consistent with other studies on COVID-19 infection risk in cancer survivors, where COVID-19 severity and sequelae were independent of cancer history and were likely associated with factors such as intensive care unit admission, noncancer comorbid conditions, and long-term care residency. IMPACT: This study can inform COVID-19 risk-counseling of cancer survivors and their caregivers as we continue to contend with COVID-19.

Supplemental breast cancer screening after negative mammography in U.S. women with dense breasts.

The extent and determinants of supplemental screening among women with dense breasts are unclear. We evaluated a retrospective cohort of 498,855 women aged 40-74 years with heterogeneously or extremely dense breasts who obtained 1,176,251 negative screening mammography examinations during 2011-2019 in the United States. Overall, 2.8% and 0.3% of mammograms had supplemental ultrasound or MRI within one year, respectively. Onsite availability was associated with ultrasound (odds ratio [OR]=4.35; 95%CI : 4.21-4.49) but not MRI (OR = 0.94; 95%CI : 0.85-1.04). Facility academic affiliation and for-profit status were inversely associated with supplemental ultrasound (OR = 0.53; 95%CI : 0.49-0.57 and OR = 0.83; 95%CI : 0.81-0.86, respectively) and positively associated with supplemental MRI (OR = 3.04; 95%CI : 2.86-3.46 and OR = 1.88; 95%CI : 1.66-2.12, respectively). Supplemental screening was more likely to occur after passage of state-specific density notification laws than before passage (OR = 3.56; 95%CI 3.30-3.84 and OR = 1.79; 95%CI 1.60-2.00, respectively). These results show that supplemental breast imaging utilization has been uncommon and was related to facility factors and density legislation.

Impact of Surveillance Mammography Intervals Less Than One Year on Performance Measures in Women With a Personal History of Breast Cancer.

OBJECTIVE: When multiple surveillance mammograms are performed within an annual interval, the current guidance for one-year follow-up to determine breast cancer status results in shared follow-up periods in which a single breast cancer diagnosis can be attributed to multiple preceding examinations, posing a challenge for standardized performance assessment. We assessed the impact of using follow-up periods that eliminate the artifactual inflation of second breast cancer diagnoses. MATERIALS AND METHODS: We evaluated surveillance mammograms from 2007-2016 in women with treated breast cancer linked with tumor registry and pathology outcomes. Second breast cancers included ductal carcinoma in situ or invasive breast cancer diagnosed during one-year follow-up. The cancer detection rate, interval cancer rate, sensitivity, and specificity were compared using different follow-up periods: standard one-year follow-up per the American College of Radiology versus follow-up that was shortened at the next surveillance mammogram if less than one year (truncated follow-up). Performance measures were calculated overall and by indication (screening, evaluation for breast problem, and short interval follow-up). RESULTS: Of 117971 surveillance mammograms, 20% (n = 23533) were followed by another surveillance mammogram within one year. Standard follow-up identified 1597 mammograms that were associated with second breast cancers. With truncated follow-up, the breast cancer status of 179 mammograms (11.2%) was revised, resulting in 1418 mammograms associated with unique second breast cancers. The interval cancer rate decreased with truncated versus standard follow-up (3.6 versus 4.9 per 1000 mammograms, respectively), with a difference (95% confidence interval [CI]) of -1.3 (-1.6, -1.1). The overall sensitivity increased to 70.4% from 63.7%, for the truncated versus standard follow-up, with a difference (95% CI) of 6.6% (5.6%, 7.7%). The specificity remained stable at 98.1%. CONCLUSION: Truncated follow-up, if less than one year to the next surveillance mammogram, enabled second breast cancers to be associated with a single preceding mammogram and resulted in more accurate estimates of diagnostic performance for national benchmarks.

A randomized controlled trial of behavioral weight loss treatment versus combined weight loss/depression treatment among women with comorbid obesity and depression.

BACKGROUND: Obesity is associated with clinical depression among women. However, depressed women are often excluded from weight loss trials. PURPOSE: This study examined treatment outcomes among women with comorbid obesity and depression. METHODS: Two hundred three (203) women were randomized to behavioral weight loss (n = 102) or behavioral weight loss combined with cognitive-behavioral depression management (n = 101). RESULTS: Average participant age was 52 years; mean baseline body mass index was 39 kg/m(2). Mean Patient Health Questionnaire and Hopkins Symptom Checklist (SCL-20) scores indicated moderate to severe baseline depression. Weight loss and SCL-20 changes did not differ between groups at 6 or 12 months in intent-to-treat analyses (p = 0.26 and 0.55 for weight, p = 0.70 and 0.25 for depressive symptoms). CONCLUSIONS: Depressed obese women lost weight and demonstrated improved mood in both treatment programs. Future weight loss trials are encouraged to enroll depressed women.

Time trends in radiologists' interpretive performance at screening mammography from the community-based Breast Cancer Surveillance Consortium, 1996-2004.

PURPOSE: To examine time trends in radiologists' interpretive performance at screening mammography between 1996 and 2004. MATERIALS AND METHODS: All study procedures were institutional review board approved and HIPAA compliant. Data were collected on subsequent screening mammograms obtained from 1996 to 2004 in women aged 40-79 years who were followed up for 1 year for breast cancer. Recall rate, sensitivity, and specificity were examined annually. Generalized estimating equation (GEE) and random-effects models were used to test for linear trend. The area under the receiver operating characteristic curve (AUC), tumor histologic findings, and size of the largest dimension or diameter of the tumor were also examined. RESULTS: Data on 2,542,049 subsequent screening mammograms and 12,498 cancers diagnosed in the follow-up period were included in this study. Recall rate increased from 6.7% to 8.6%, sensitivity increased from 71.4% to 83.8%, and specificity decreased from 93.6% to 91.7%. In GEE models, adjusted odds ratios per calendar year were 1.04 (95% confidence interval [CI]: 1.02, 1.05) for recall rate, 1.09 (95% CI: 1.07. 1.12) for sensitivity, and 0.96 (95% CI: 0.95, 0.98) for specificity (P < .001 for all). Random-effects model results were similar. The AUC increased over time: 0.869 (95% CI: 0.861, 0.877) for 1996-1998, 0.884 (95% CI: 0.879, 0.890) for 1999-2001, and 0.891 (95% CI: 0.885, 0.896) for 2002-2004 (P < .001). Tumor histologic findings and size remained constant. CONCLUSION: Recall rate and sensitivity for screening mammograms increased, whereas specificity decreased from 1996 to 2004 among women with a prior mammogram. This trend remained after accounting for risk factors. The net effect was an improvement in overall discrimination, a measure of the probability that a mammogram with cancer in the follow-up period has a higher Breast Imaging Reporting and Data System assessment category than does a mammogram without cancer in the follow-up period.

Does depression reduce the effectiveness of behavioral weight loss treatment?

Limited evidence suggests that depression is associated with poorer outcomes in behavioral weight loss programs; however, people with major depression are typically excluded from weight loss intervention trials. This study examined the effect of depression on women's participation and weight loss in behavioral treatment. Non-treatment seeking obese women over 40 years of age with major depressive disorder (MDD, n = 65) and without MDD (n = 125) were recruited into a 26-session group intervention. Primary analyses compared participants' mean weight change from baseline to 6 and 12 months; at 6 months, women with MDD lost a mean of 3.8 kg vs 4.3 kg for women without MDD (t = 0.54, p = .59). At 12 months, women with MDD lost 3.0 kg and women without MDD lost 3.6 kg (t = 0.44, p =.66). Women who attended at least 12 treatment sessions lost more weight than women who attended fewer sessions, regardless of depression status (ie, there was no significant interaction between depression and session attendance). Results suggest that depression should not be an exclusion criterion for weight loss intervention programs.

Navel jewelry artifacts and intravertebral variation in spine bone densitometry in adolescents and young women.

Non-removable navel jewelry can increase the measured bone density of the underlying vertebra. We measured lumbar spine bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) in an observational study of 727 adolescents and young women aged 14-30 yr. We evaluated several methods of correcting BMD: manually erasing a small area, eliminating 1 or 2 vertebrae, estimating the BMD from 1 or 2 vertebrae using data from remaining vertebrae, and estimating the BMD using T-scores of the remaining vertebrae. Ten percent (n=71) of the subjects were wearing navel jewelry. The areal BMD by DXA of L1 and L2 was similar in those with jewels as in controls without jewels, but L3-L4 showed higher bone density in those with jewelry, and the spine BMD of L1-L4 was significantly higher in the bejeweled women (1.043+/-0.011 vs 1.006+/-0.004 g/cm2, p=0.01). The estimated errors in accuracy (g/cm2) were 0.034 due to the jewels; 0.005 from erasing a small area; 0.019 from eliminating L4; 0.044 from eliminating both L3 and L4; 0.016 from predicting BMD using L1-L3; and 0.028 using L1-L2. The T-scores using the Hologic database were progressively lower in the caudal vertebrae, even in 96 local women aged 30-35 yr, whose average T-score was 0.35 at L1 but -0.26 at L4. Thus, we found significant errors due to intravertebral variability. We suggest the optimal method of correcting for small artifacts is to erase the area under the artifact.

Reported food choices in older women in relation to body mass index and depressive symptoms.

This paper examines the relationships among reports of depressive symptoms, BMI and frequency of consumption of 30 foods in 4655 middle-aged women. Food was grouped into three categories: high-calorie sweet, high-calorie nonsweet, and low-calorie. Controlling for total energy intake, BMI and depressive symptoms were both inversely associated with a higher frequency of consumption of low-calorie foods. BMI was positively associated with consumption of high-calorie nonsweet foods and negatively related to consumption of high-calorie sweet foods. Depressive symptoms were positively associated with sweet foods consumption and negatively associated with nonsweet foods consumption. These findings suggest that the positive association between BMI and depression in women may be mediated by sweets consumption. This is consistent with the hypothesis that eating sweet foods reduces negative affect.

Oral contraceptive use and fracture risk around the menopausal transition.

OBJECTIVE: The effect of oral contraceptive (OC) use on risk of fracture remains unclear, and use during later reproductive life may be increasing. To determine the association between OC use during later reproductive life and risk of fracture across the menopausal transition, we conducted a population-based case-control study in a Pacific Northwest HMO, Group Health Cooperative. METHODS: For the January 2008 to March 2013 interval, 1,204 case women aged 45 to 59 years with incident fractures, and 2,275 control women were enrolled. Potential cases with fracture codes in automated data were adjudicated by electronic health record review. Potential control women without fracture codes were selected concurrently, sampling based on age. Participants received a structured study interview. Using logistic regression, associations between OC use and fracture risk were calculated as odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Participation was 69% for cases and 64% for controls. The study sample was 82% white; mean age was 54 years. The most common fracture site for cases was the wrist/forearm (32%). Adjusted fracture risk did not differ between cases versus controls for OC use in the 10 years before menopause (OR 0.90, 95% CI 0.74, 1.11); for OC use after age 38 (OR 0.94, 95% CI 0.78, 1.14); for duration of use, or for other OC exposures. CONCLUSIONS: The current study does not show an association between fractures near the menopausal transition and OC use in the decade before menopause or after age 38. For women considering OC use at these times, fracture risk does not seem to be either reduced or-reassuringly-increased.

Change in bone mineral density among adolescent women using and discontinuing depot medroxyprogesterone acetate contraception.

BACKGROUND: Several studies report an association between depot medroxyprogesterone acetate (DMPA) injectable contraception and decreased bone mineral density. Adolescents, who are still gaining bone, may be particularly affected, but there has been little study of the association in adolescent users and none following discontinuation. OBJECTIVE: To evaluate bone mineral density changes in adolescents using and discontinuing use of DMPA contraception. DESIGN: A population-based prospective cohort study. PARTICIPANTS: One hundred seventy adolescent women, aged 14 to 18 years; 80 baseline DMPA users and 90 age-similar, unexposed comparison women. Sixty-one participants discontinued DMPA use during follow-up. MAIN OUTCOME MEASURE: Bone mineral density, measured every 6 months for 24 to 36 months at the hip, spine, and whole body, comparing mean bone mineral density changes in DMPA users and discontinuers with nonusers. RESULTS: Among DMPA users, bone mineral density declined significantly relative to nonusers at the hip and spine but not the whole body. Annualized mean percentage changes, adjusted for covariates, were hip, -1.81% vs -0.19%; P<.001; spine, -0.97% vs 1.32%; P<.001, and whole body, 0.73% vs 0.88%; P = .78 for DMPA users vs nonusers, respectively. New users lost bone mineral density more rapidly than prevalent users. Discontinuers experienced significantly increased bone mineral density relative to nonusers at all anatomical sites; annualized mean percentage changes were hip, 1.34% vs -0.19%; P = .004; spine, 2.86% vs 1.32%; P = .004; and whole body, 3.56% vs 0.88%; P<.001. CONCLUSIONS: Use of DMPA contraception in adolescents was associated with significant continuous losses of bone mineral density at the hip and spine. However, significant gains postdiscontinuation provide evidence that the loss of bone mass is apparently reversed.

A comparison of self-reported oral contraceptive use and automated pharmacy data in perimenopausal and early postmenopausal women.

PURPOSE: Oral contraceptive (OC) use can occur throughout a woman's reproductive life span with the potential for long-term impacts on health. To assess potential measurement error in prior OC use, this study compared level of agreement between self-reported prior OC use and pharmacy dispensing data in perimenopausal and/or early postmenopausal women. METHODS: The study's 1399 women (ages, 45-59 years) were participants in a population-based case-control study of the association between OC use and fracture risk. Episodes of lifetime self-reported OC use (in months) were collected, by telephone interview, for January 1, 2008 through November 25, 2012. Pharmacy fills, back to 1980, were collected from automated data. Agreement was measured using the prevalence-adjusted and bias-adjusted kappa index. RESULTS: The number of women with OC pharmacy fills was 11% to 45% higher than those who reported OC use during each time period. Between-measures agreement was better for more recent use. Prevalence-adjusted and bias-adjusted kappa index values ranged from 0.88 (95% confidence interval, 0.85-0.90) within 5 years from the reference date to 0.65 (95% confidence interval, 0.59-0.71) within 15 to 20 years. CONCLUSIONS: For studies designed to assess the long-term effects of OC use, the current results are reassuring in noting moderate agreement between self-reported OC use and pharmacy data for up to 15 to 20 years before the interview.

A tailored minimal self-help intervention to promote condom use in young women: results from a randomized trial.

OBJECTIVE: To evaluate the efficacy of a theory-based tailored minimal self-help intervention to increase condom use among young women at risk for HIV/sexually transmitted disease (STD). DESIGN: Randomized controlled trial on an intent-to-treat basis in two managed care plans, in Washington state and North Carolina, with follow-up at 3 and 6 months. PARTICIPANTS: A proactively recruited sample of 1210 heterosexually active, non-monogamous, non-pregnant women, aged 18-24 years recruited June 1999-April 2000; 85% completed the 6-month follow-up. METHOD: Arm 1 received usual care. Arm 2 received a mailed computer-generated self-help magazine, individually tailored on survey items including stage of readiness to use condoms, barriers to condom use, partner type; condom samples and a condom-carrying case were included in the packet; this was followed 3 months later by a tailored 'booster' newsletter. The a priori 6-month main outcomes were percentage of women using condoms during the previous 3 months (overall and by partner type) and proportion of total episodes of intercourse during which condoms were used in the previous 3 months. RESULTS: Relative to usual care, intervention group women reported significantly more condom use overall [adjusted odds ratio (OR), 1.86; 95% confidence interval (CI), 1.32-2.65; P = 0.0005] and with recent primary partners (OR, 1.97; 95% CI, 1.37-2.86; P = 0.0003). They also reported using condoms for a higher proportion of intercourse episodes (52.7% versus 47.9%; P = 0.05). Significantly more intervention women carried condoms, discussed condoms with partners, and had higher self-efficacy to use condoms with primary partners. CONCLUSIONS: Tailored cognitive/behavioral minimal self-help interventions hold promise as HIV/STD prevention strategies for diverse populations of young at-risk women.

Effect of low-dose thiazide diuretics on plasma lipids: results from a double-blind, randomized clinical trial in older men and women.

OBJECTIVES: To determine the effects of low doses of hydrochlorothiazide (HCTZ) on plasma lipids in healthy older men and women. DESIGN: Randomized, double-blind, placebo-controlled clinical trial for 3 years followed by a 1 year extension without medication. SETTING: Research clinic of a nonprofit health maintenance organization. PARTICIPANTS: Two hundred five women and 115 men aged 60 to 79 with normal blood pressure, bone density within two standard deviations of mean for age, and low-density lipoprotein cholesterol (LDL-C) levels less than 190 mg/dL. INTERVENTION: Placebo or HCTZ 12.5 or 25 mg/d. MEASUREMENTS: Plasma cholesterol, LDL-C, high-density lipoprotein cholesterol, triglycerides. RESULTS: There were no significant differences in the change in the plasma lipids between placebo and either group. The mean changes +/- standard deviation in LDL-C after 3 years in men were -5.2 +/- 3.9 mg/dL (placebo), -4.6 +/- 3.7 (12.5 mg), and 1.1 +/- 3.8 (25 mg) and in women were 1.3 +/- 2.8 (placebo), -1.1 +/- 2.8 (12.5 mg), and -6.8 +/- 2.8 (25 mg). No significant differences were seen when analysis was done only for subjects who adhered to study medication. CONCLUSION: This study provides evidence that low doses of thiazide diuretics have minimal effects on cholesterol metabolism in healthy older adults. Therefore, effects on lipid levels need not limit use of thiazides for prevention of osteoporotic fractures.

The association between depot medroxyprogesterone acetate contraception and bone mineral density in adolescent women.

Although adolescent women are actively acquiring bone, there has been little study of the possible effects of depot medroxyprogesterone acetate (DMPA) injectable contraception use on bone density in adolescents. We conducted a cross-sectional evaluation of the association between DMPA use and bone mineral density in adolescent women, ages 14-18 years. Of 174 study participants, 81 were DMPA users (range, 1-13 injections, median = 3) and 93 were not. Mean bone density at all anatomic sites (hip, spine and whole body) was lower for DMPA users than nonusers, but differences were not statistically significant (e.g., hip, 0.940 vs. 0.970 g/cm2, p = 0.10; spine, 0.970 vs. 0.992 g/cm2, p = 0.19). Duration of DMPA use showed a trend toward lower spine bone density (p-value for trend = 0.06). This study did not find a strong association between DMPA use and bone density. Further prospective evaluation of bone density changes with DMPA use and after DMPA discontinuation are needed in this age group.

Longitudinal changes in bone density in relation to oral contraceptive use.

The primary aim of this 36-month prospective cohort study was to evaluate the association between use of oral contraceptives (OCs) and bone mineral density in reproductive-age women. The 36-month bone density (g/cm2) at the spine, hip and whole body and percent change from baseline (measured at 6-month intervals) were evaluated among 245 women 18-39 years of age; 89 were using OCs (median duration: 3.7 years at study entry) and 156 were not using any hormonal contraception. Before and after adjustment for covariates (baseline bone density, age, race, ever pregnant, exercise, body mass and calcium intake), women using OCs did not differ significantly from comparison women in percent change in bone density over 36 months or in absolute bone density at 36 months. All p-values for between-group differences were >0.55. In conclusion, within the limitations of this study, OCs did not appear to impact bone density over time in this cohort of reproductive-age women.

Oral contraceptive use and bone density change in adolescent and young adult women: a prospective study of age, hormone dose, and discontinuation.

CONTEXT: Oral contraceptive (OC) use is common, but bone changes associated with use of contemporary OC remain unclear. OBJECTIVE: The objective of the study was to compare bone mineral density (BMD) change in adolescent and young adult OC users and discontinuers of two estrogen doses, relative to nonusers. DESIGN AND SETTING: This was a prospective cohort study, Group Health Cooperative. PARTICIPANTS: Participants included 606 women aged 14-30 yr (50% adolescents aged 14-18 yr): 389 OC users [62% 30-35 µg ethinyl estradiol (EE)] and 217 age-similar nonusers; there were 172 OC discontinuers. The 24-month retention was 78%. MAIN OUTCOME MEASURE: The main outcome measure was BMD measured at 6-month intervals for 24-36 months. RESULTS: After 24 months, adolescents using 30-35 µg EE OCs, but not those using lower-dose OCs, had significantly smaller adjusted mean percentage BMD gains than nonusers at the spine [group means (95% confidence interval for between group differences) 1.32 vs. 2.26% (-1.89, -0.13%)] and whole body [1.45 vs. 2.03% (-1.29%, -0.13%)]. Adolescents who discontinued 30-35 µg EE OC showed significantly smaller gains than nonusers at the spine after 12 months [0.51 vs. 1.72% (-2.38%, -0.30%)]. Young adult OC users did not differ from nonusers. However, OC discontinuers of both doses differed significantly from nonusers at the spine 12 months after discontinuation [-1.32% < 30 µg EE, -0.92% 30-35 µg EE vs. +0.27% nonusers (-2.48, -0.54, and -1.94%, -0.55%, respectively)]. Results were similar for mean absolute BMD change (grams per square centimeter). CONCLUSIONS: Both OC use and discontinuation were associated with BMD losses/smaller gains relative to nonusers (differences < 2% after 12-24 months for all skeletal sites). The clinical significance of these results regarding future fracture risk is unknown. Study of longer-term trends after discontinuation is needed.