Sleep Health and Anxiety Symptoms in Midlife Women: The Study of Women's Health Across the Nation (SWAN).

Purpose: To investigate the associations between anxiety symptoms in midlife women and sleep features later in life, the aim is to test the hypothesis that poor sleep, as measured by each of six individual dimensions (4 objective actigraphy measures, 2 self-reports) of sleep health, is associated with higher levels of anxiety symptoms in midlife women. Participants and Methods: The participants in this longitudinal analysis included women from the SWAN Sleep I Study, a subcohort of the community-dwelling midlife women participating in the core Study of Women's Health Across the Nation (SWAN), which was initiated in 1996. Of the 370 participants enrolled in the Sleep Study, 270 were included in the analytic sample, and 100 who did not meet the inclusion criteria were excluded. Baseline measures of six dimensions of multidimensional sleep health (actigraphy measures: efficiency, duration, mid-sleep timing, regularity; self-report measures: alertness, satisfaction) were obtained between 2003 and 2005, corresponding to SWAN core annual/biennial assessments 5-8. Associations of each dimension with self-reported anxiety symptoms (Generalized Anxiety Disorder - 7-item scale; GAD-7), collected during visits 12 (2009-2011), 13 (2011-2013), and 15 (2015-2017), were examined using mixed models. The GAD-7 outcome was measured both continuously and as a categorical variable due to its skewed distribution. Results: No statistically significant associations were found between any of the six baseline sleep health dimensions and the GAD-7 score after adjustment for covariates. Conclusion: The reasons for the lack of support for our hypothesis, despite previous evidence supporting an association between sleep and anxiety, are unclear. There is considerable overlap between anxiety and sleep symptoms, which may complicate the interpretation of our the findings. Thus, the failure to identify associations is likely multifactorial, and more studies with shorter follow-up intervals are warranted to better understand these relationships.

Insights into the Feasibility and Acceptability of a Mobile Insulin Titration Application in Clinical Practice and Its Effects on Diabetes Outcomes.

Introduction: Insulin therapy is most effective if patients learn how to properly adjust insulin to achieve glycaemic targets. There is a need for methods and tools that can assist these processes in clinical practice. The purpose of this feasibility study was to evaluate an approach to support insulin dose adjustment in individual patients using a mobile titration application (app). Methods: A cohort of adults (N=36) with type 2 diabetes with suboptimal glycaemia who were starting basal insulin self-titration were trained by a diabetes care and education specialist to use a mobile titration app to guide adjusting insulin doses. Glycaemia, diabetes distress and patient and provider satisfaction were assessed during the first 3 months after initiating basal insulin titration using the mobile app. Results: Mean haemoglobin type A1c (HbA1c) was significantly reduced by an average of 2.1 ± 2.2% from baseline to 3 months (p<0.001). Diabetes distress significantly decreased from baseline to follow-up with scores going down (or improving) across all scales. Both patients and providers reported high levels of satisfaction and positive experiences. Conclusion: The model offers a promising solution to streamline insulin dosage adjustments to achieve specific clinical and self-management goals with high expectations for long-term benefits and warrants further investigation.

The effect of starting metformin on bone mineral density among women with type 2 diabetes in the Study of Women's Health Across the Nation (SWAN).

We examined longitudinal changes in BMD among women in the mid-life starting metformin. Study subjects were 57 years old (mean), and 36% were White. Women initiating metformin were similar to noninitiators. During the 3-year follow-up, BMD loss at all anatomic areas was similar between groups and in subgroups including baseline fasting blood glucose. PURPOSE/INTRODUCTION: Women with type 2 diabetes have higher bone mineral density (BMD), experience slower BMD loss, but have increased fracture risk. Data regarding the effect of metformin on BMD remain discordant. We examined longitudinal changes in BMD among women in the mid-life starting metformin. METHODS: Participants in the Study of Women's Health Across the Nation (SWAN), a diverse community-based US cohort, with BMD measurements were evaluated. Propensity score matching helped balance baseline characteristics of metformin initiators versus noninitiators. Mixed model regression tested the change in BMD between groups. RESULTS: Subjects (n = 248) were 57.4 years old (mean), and 35.9% were White. Women initiating metformin (n = 124) were similar to noninitiators (n = 124) in age and race/ethnicity. During the median 3-year follow-up, BMD loss at all anatomic areas was similar between the metformin initiators and nonusers (all p > 0.3). Subgroup analyses including baseline fasting blood glucose showed no between-group differences. Initiation of metformin (vs. not) in peri-menopausal women was not associated with BMD changes. CONCLUSIONS: Women in the mid-life starting metformin had longitudinal changes in BMD very similar to other women not starting metformin.

Self-Reported Sleep Disturbances over the Menopausal Transition and Fracture Risk: The Study of Women's Health Across the Nation.

Sleep disturbances are common and may impact fracture risk directly by influencing bone turnover or indirectly through shared risk factors or mediators. To investigate the association between self-reported sleep disturbances across the menopausal transition (MT) and fractures, we prospectively studied 3101 women enrolled in the Study of Women's Health Across the Nation (SWAN). At each of 14 study visits spaced approximately 18 months apart, a standardized validated scale ascertained trouble falling asleep, waking up several times during the night, and waking up earlier than planned. Two time-varying exposures were modeled: presence of any of the three disturbances at least three times per week and waking up several times during the night at least three times per week. Base models adjusted for fixed (race/ethnicity, study site) and time-varying characteristics (age, body mass index, and MT stage). Fully adjusted models also included time-varying bone beneficial and detrimental medications, smoking, alcohol, physical activity, diabetes, depression and sleep medications, and depressive symptoms. Women who experienced a fracture were more likely to report a greater frequency of having trouble falling asleep, waking up several times, and/or waking up earlier: 35% versus 30% at baseline, p = 0.02. In the base models, women who had any of the three sleep disturbances at least three times per week had a higher risk of any fracture, odds ratio (OR) = 1.23 (95% confidence intervals, 1.02, 1.48) and nontraumatic fracture, OR = 1.36 (1.03, 1.80). These associations were largely attenuated to nonsignificance in the fully adjusted model. Sensitivity analyses limiting our sample to 2315 SWAN women enrolled in the bone mineral density (BMD) centers yielded similar results. Additional adjustment for femoral neck BMD had no effect on our results. In conclusion, self-reported sleep disturbances were associated with an increased risk of fractures, but these associations likely reflect shared risk factors or factors in the causal pathway. © 2023 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Derivation and external validation of a risk score for clinically important declines in health and function among two longitudinal cohorts of women in the mid-life.

OBJECTIVES: Women in mid-life often develop chronic conditions and experience declines in physical health and function. Identifying factors associated with declines provides opportunity for targeted interventions. We derived and externally validated a risk score for clinically important declines over 10 years among women ages 55-65 using the Physical Component Summary Score (PCS) of the SF-36. DESIGN: Derivation and validation of a risk score. SETTING: Two longitudinal cohorts from sites in the USA were used. PARTICIPANTS: Women from the Study of Women's Health Across the Nation (SWAN) and women from the Women's Health Initiative (WHI) Observational Study and/or clinical trials. OUTCOME MEASURES: A clinically important decline over 10 years among women ages 55-65 using the PCS of the SF-36 predictors was measured at the beginning of the 10 years of follow-up. RESULTS: Seven factors-lower educational attainment, smoking, higher body mass index, history of cardiovascular disease, history of osteoarthritis, depressive symptoms and baseline PCS level-were found to be significant predictors of PCS decline among women in SWAN with an area under the curve (AUC)=0.71 and a Brier Score=0.14. The same factors were associated with a decline in PCS in WHI with an AUC=0.64 and a Brier Score=0.18. Regression coefficients from the SWAN analysis were used to estimate risk scores for PCS decline in both cohorts. Using a threshold of a 30% probability of a significant decline, the risk score created a binary test with a specificity between 89%-93% and an accuracy of 73%-79%. CONCLUSIONS: Seven clinical variables were used to create a valid risk score for PCS declines that was replicated in an external cohort. The risk score provides a method for identifying women at high risk for a significant mid-life PCS decline.

Examining a Diabetes Self-Management Education and Support Telemedicine Model With High-Risk Patients in a Rural Community.

BACKGROUND: Ongoing support is critical to diabetes self-management education and support (DSMES) effectiveness, but difficult to realize, particularly in areas with limited resources. The objective of this feasibility study was to assess the impact of a virtual support model on diabetes outcomes and acceptability with high-risk patients with type 2 diabetes in a rural community. METHODS: In a 12-month nonrandomized trial in federally qualified health centers (FQHCs), patients with hemoglobin A1c (HbA1c) >9% were referred to the Telemedicine for Reach, Education, Access, Treatment, and Ongoing Support (TREAT-ON) program where a Diabetes Care and Education Specialist provided DSMES through videoconferencing. HbA1c change was compared in 30 patients in the intervention group (IG) to a propensity score-matched retrospective control group (CG) of patients who received in-person DSMES delivered by a DCES. Changes in HbA1c, diabetes distress, empowerment, self-care and acceptability were assessed within the intervention group (IG) between those who did and did not meet self-management goals. RESULTS: The IG experienced similar significant reductions in HbA1c as the CG. Most (64%) IG participants achieved their self-management goal. Goal attainers had a significant HbA1c decrease of 0.21% every 3 months as well as significant reduction in diabetes distress and improvement in general dietary intake. Regardless of goal attainment, IG participants reported high levels of acceptability with TREAT-ON. CONCLUSIONS: This feasibility study suggests that TREAT-ON was well-received and as effective as traditional in-person DSMES. While findings augment ample evidence regarding DSMES benefits, the TREAT-ON model offers additional advantages and provides validation for telehealth to inform future practice in reaching and supporting self-management for high-risk patients in underserved areas. TRIAL REGISTRATION: Clinicaltrials.gov, # NCT04107935.

Physical and Behavioral Factors Associated With Improvement in Physical Health and Function Among US Women During Midlife.

Importance: Women often experience physiological and functional changes in their health during midlife. Identifying women who have clinically important improvements in physical health and function and evaluating the factors associated with these improvements can identify intervention targets at midlife. Objective: To identify factors associated with improvements in physical health and function among women during midlife. Design, Setting, and Participants: Participants were part of the Study of Women's Health Across the Nation (SWAN), a diverse cohort of US women early in midlife, and followed up annually for up to 21 years between 1996 and 2017. Analyses were based on visit 8 (2004-2006) through visit 15 (2015-2017). Statistical analysis was conducted from October 2021 to March 2023. Exposures: Sociodemographic indicators, health status measures, and comorbidities measured at visit 8. Main Outcomes and Measures: The main outcome was a clinically important (≥5 points) improvement in the physical component score (PCS) of the 36-item Short-Form Health Survey between visit 8 and visit 15. Results: Of the 1807 women (at visit 8: mean [SD] age, 54.5 [2.7] years; 898 [50%] White participants) in SWAN who qualified for analysis, 265 (15%) experienced a clinically important improvement in PCS over a median of 11.1 years (IQR, 10.9-11.4 years). Factors associated with improvement in PCS included no financial strain (odds ratio [OR], 1.73; 95% CI, 1.18-2.52), no sleep disturbances (OR, 1.43; 95% CI, 1.05-1.96), no osteoarthritis (OR, 1.42; 95% CI, 1.01-1.99), and having a higher physical activity score (OR, 1.17; 95% CI, 1.00-1.37) as assessed at visit 8. Women who had a higher PCS at visit 8 (OR, 0.84; 95% CI, 0.83-0.86), who had a higher body mass index (OR, 0.95; 95% CI, 0.93-0.97), or who were taking more medications (OR, 0.93; 95% CI, 0.88-0.98) had lower odds of an improved PCS. Conclusions and Relevance: This cohort study of women in midlife suggests that approximately 15% of women experienced clinically important improvements in health and function over an 11-year period. Several potentially modifiable factors associated with improvements may inform women of variables to target for future interventions.

Comparison of robotic-assisted minimally invasive esophagectomy versus minimally invasive esophagectomy: A propensity-matched study from a single high-volume institution.

OBJECTIVE: Robotic-assisted minimally invasive esophagectomy accounts for a growing proportion of esophagectomies, potentially due to improved technical capabilities simplifying the challenging aspects of standard minimally invasive esophagectomy. However, there is limited evidence directly comparing both operations. The objective is to evaluate the short-term and long-term outcomes of robotic-assisted minimally invasive esophagectomy in comparison with the minimally invasive esophagectomy approach for patients with esophageal cancer over a 7-year period at a high-volume center. The primary end points of this study were overall survival and disease-free survival. Secondary end points included operation-specific morbidity, lymph node yield, readmission status, and in-hospital, 30-day, and 90-day mortality. METHODS: Patients who underwent robotic-assisted minimally invasive esophagectomy or standard minimally invasive esophagectomy over a 7-year period were identified from a prospectively maintained database. Inclusion criteria were patients with stage I to III disease, operations performed past the learning curve, and no evidence of scleroderma or cirrhosis. A 1:3 propensity match (robotic-assisted minimally invasive esophagectomy:minimally invasive esophagectomy) for multiple clinical covariates was performed to identify the final study cohort. Perioperative outcomes were compared between the 2 operations. RESULTS: A total of 734 patients undergoing minimally invasive esophagectomy (n = 630) or robotic-assisted minimally invasive esophagectomy (n = 104) for esophageal cancer were identified. After exclusions and matching, a total cohort of 246 patients undergoing robotic-assisted minimally invasive esophagectomy (n = 65) or minimally invasive esophagectomy (n = 181) were identified. There was no difference in overall survival (P = .69) or disease-free survival (P = .70). There were no significant differences in rates of major morbidity: pneumonia (17% vs 17%, P = .34), chylothorax (8% vs 9%, P = .95), recurrent laryngeal nerve injury (0% vs 1.5%, P = 1), anastomotic leak (5% vs 4%, P = .49), intraoperative complications (9% vs 8%, P = .73), or complete resection rates (99% vs 96%, P = .68). There was no difference in in-hospital (P = .89), 30-day (P = .66) or 90-day mortality (P = .73) between both cohorts. The robotic-assisted minimally invasive esophagectomy cohort yielded a higher median lymph node harvest in comparison with the minimally invasive esophagectomy cohort (32 vs 29, P = .02). CONCLUSIONS: Robotic-assisted minimally invasive esophagectomy may improve lymphadenectomy in patients undergoing esophagectomy for cancer. Minimally invasive esophagectomy and robotic-assisted minimally invasive esophagectomy are otherwise associated with similar mortality, morbidity, and perioperative outcomes. Further prospective study is required to investigate whether improved lymph node resection may translate to improved oncologic outcomes.

Sleep timing, sleep regularity, and psychological health in early late life women: Findings from the Study of Women's Health Across the Nation (SWAN).

OBJECTIVES: To examine the associations of actigraphy-assessed sleep timing and regularity with psychological health in early late life women, whose circadian rhythms may be impacted by aging. DESIGN: Cross-sectional. PARTICIPANTS: A racially/ethnically diverse sample of 1197 community-dwelling women (mean age 65 years) enrolled in the Study of Women's Health Across the Nation. MEASURES: Actigraphy-assessed sleep measures included timing (mean midpoint from sleep onset to wake-up) and regularity (standard deviation of midpoint in hours). Psychological health measures included a composite well-being score, the Center for Epidemiological Studies Depression Scale, and the Generalized Anxiety Disorder-7 Scale. Linear and logistic regression models, adjusted for covariates (including sleep duration), tested associations between sleep and psychological health measures. RESULTS: After covariate adjustment, a sleep midpoint outside of 2:00-4: 00 AM was significantly associated with depressive symptoms (ß = 0.88, 95% CI = 0.06, 1.70) and scoring above the cut-point for clinically significant depressive symptoms (OR = 1.72, 95% CI = 1.15, 2.57). Sleep irregularity was significantly associated with lower psychological well-being (ß = -0.18, 95% CI = -0.33, -0.03), depressive (ß = 1.36, 95% CI = 0.29, 2.44) and anxiety (ß = 0.93, 95% CI = 0.40, 1.46) symptoms, and scoring above the cut-point for clinically significant depressive (OR = 1.68, 95% CI = 1.01, 2.79) and anxiety (OR = 1.62, 95% CI = 1.07, 2.43) symptoms. CONCLUSION: Above and beyond sleep duration, a sleep midpoint outside of 2:00-4:00 AM was associated with depressive symptoms while sleep irregularity was associated with multiple psychological health domains in late life women.

Examining Parental Acceptance of Confidential Contraception Initiation in a Pediatric Emergency Department.

BACKGROUND: The pediatric emergency department (PED) is a valuable site for contraceptive services among adolescents at risk for pregnancy. Studies have shown that adolescents are interested in such services; however, little is known about parental opinions on contraceptive care in the PED. We aimed to (1) assess parental acceptance of confidential provisions of contraception in the PED and (2) identify facilitators/barriers to parental acceptance of contraception in this setting. METHODS: This study included parents/guardians of females aged 14 to 19 years who presented to the PED with any chief complaint. Participants completed a self-administered 25-question survey based on previously validated questions to assess their acceptance of contraception provisions, both confidentially and with parental involvement, for their adolescent in the PED. χ 2 or Fisher exact tests were used to examine variables associated with parental acceptance of confidential contraception. RESULTS: Of the 102 parents/guardians surveyed, most parents (58/102, 57%) were accepting of confidential contraception for their adolescent. However, more parents (82/101, 81%) were accepting of contraception in the ED with their involvement, as opposed to confidentially without their involvement. Those accepting had an increased perceived risk of their adolescent having sex or becoming pregnant (mean [SD], 13 [20]; P = 0.02; odds ratio, 1.05; 95% confidence interval, 1.00-1.09), were aware of their adolescent's rights to confidential contraception (62%; P = 0.006; odds ratio, 3.18; 95% confidence interval, 1.39-7.28), and had slightly older teens (16 vs 15.5 years, P = 0.01). More parents accepted OCPs over IUDs in the PED (53/58, 91% vs 26/57, 46%). CONCLUSIONS: Although most parents were accepting of the PED provider offering confidential contraception to their adolescent, more parents preferred to be involved with decisions regarding contraception, in a collaborative approach. Further research is necessary to better elucidate parental/adolescent preferences.

Sternotomy Wound Infiltration With Liposomal Versus Plain Bupivacaine for Postoperative Analgesia After Elective Cardiac Surgery.

OBJECTIVES: Poor pain control after cardiac surgery can be associated with postoperative complications, longer recovery, and development of chronic pain. The authors hypothesized that adding liposomal bupivacaine (LB) to plain bupivacaine (PB) will provide better and long-lasting analgesia when used for wound infiltration in median sternotomy. STUDY DESIGN: Prospective, randomized, and double-blinded clinical trial. SETTING: Single institution, tertiary care university hospital. PARTICIPANTS: Adult patients who underwent elective cardiac surgery through median sternotomy. INTERVENTIONS: A single surgeon performed wound infiltration of LB plus PB or PB into the sternotomy wound, chest, and mediastinal tube sites. MEASUREMENTS AND MAIN RESULTS: Patients were followed up for 72 hours for pain scores, opioid consumption, and adverse events. Sixty patients completed the study for analysis (LB group [n = 29], PB group [n = 31]). Patient characteristics, procedural variables, and pain scores measured at specific intervals from 4 hours until 72 hours postoperatively did not reveal any significant differences between the groups. Mixed-model regression showed that the trend of mean pain scores at movement in the LB group was significantly (p = 0.01) lower compared with the PB group. Opioid consumption over 72 hours was not significantly different between the 2 groups (oral morphine equivalents; median [interquartile range], 139 [73, 212] mg in LB v 105 [54, 188] mg in PB, p = 0.29). Recovery characteristics and adverse events were comparable. CONCLUSIONS: LB added to PB for sternotomy wound infiltration during elective cardiac surgery did not significantly improve the quality of postoperative analgesia.

Factors Associated With 10-Year Declines in Physical Health and Function Among Women During Midlife.

Importance: Women in midlife often develop chronic conditions and experience declines in physical health and function. Identifying factors associated with declines in physical health and function among these women may allow for targeted interventions. Objective: To examine the factors associated with clinically important 10-year declines in the physical component summary score (PCS) of the Short Form 36 (SF-36), a widely used patient-reported outcome measure, in women in midlife. Design, Setting, and Participants: This longitudinal cohort study collected data from geographically dispersed sites in the US. Participants were part of the Study of Women's Health Across the Nation (SWAN), a racially and ethnically diverse cohort of women enrolled at or immediately before the menopause transition. Women have been followed for up to 21 years, between 1996 and 2016, with annual visits. Data were analyzed from October 2020 to March 2021. Exposures: Demographic indicators, health status measures, and laboratory and imaging assessments. Main Outcomes and Measures: The main outcome was a clinically important decline (≥8 points) on the PCS, based on the 10-year difference in scores between ages 55 and 65 years. Results: From the SWAN cohort of 3302 women, 1091 women (median [IQR] age, 54.8 [54.3-55.4] years; 264 [24.2%] Black women; 126 [11.6%] Chinese women; 135 [12.4%] Japanese women; 566 [51.9%] White women) were eligible for analyses based on duration of follow-up and availability of SF-36 data. At age 55, women had a median (IQR) body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27.0 (23.2-32.6), a median (IQR) baseline PCS of 53.1 (46.8-56.7), 108 women (9.9%) were current smokers, and 938 women (86.3%) had at least 1 comorbidity. Between ages 55 and 65 years, the median (IQR) change in PCS was -1.02 (-6.11 to 2.53) points with 206 women (18.9%) experiencing declines of 8 points or more. In multivariable models, factors associated with clinically important decline included higher baseline PCS (odds ratio [OR], 1.08; 95% CI, 1.06-1.11), greater BMI (OR, 1.06; 95% CI, 1.03-1.09), less educational attainment (OR, 1.87; 95% CI, 1.32-2.65), current smoking (OR, 1.93; 95% CI, 1.14-3.26), osteoarthritis (OR, 1.46; 95% CI, 1.01-2.09), clinically significant depressive symptoms (OR, 2.03; 95% CI, 1.34-3.09), and cardiovascular disease (OR, 2.06; 95% CI, 1.26-3.36). Conclusions and Relevance: In this cohort study, clinically important declines in women's physical health and function were relatively common between ages 55 and 65 years. Several variables associated with these declines were identified as potentially useful components in a clinical score identifying women at increased risk of physical health and functional declines.

Activity-Based Cost Analysis of Robotic Anatomic Lung Resection During Program Implementation.

BACKGROUND: While robotic-assisted lung resection has seen a significant rise in adoption, concerns remain regarding initial programmatic outcomes and potential increased costs. We present our initial outcomes and cost analysis since initiation of a robotic lung resection program. METHODS: Patients undergoing either video-assisted thoracoscopic lobectomy or segmentectomy (VATS) or robotic-assisted lobectomy or segmentectomy (RALS) between August of 2014 and January of 2017 underwent retrospective review. Patients underwent 1:1 propensity matching based on preoperative characteristics. Perioperative and 30-day outcomes were compared between groups. Detailed activity-based costing analysis was performed on individual patient encounters taking into effect direct and indirect controllable costs, including robotic operative supplies. RESULTS: There were no differences in 30-day mortality between RALS (n = 74) and VATS (n = 74) groups (0% vs 1.4%; P = 1). RALS patients had a decreased median length of stay (4 days vs 7 days; P < .001) and decreased median chest tube duration (3 days vs 5 days, P < .001). Total direct costs, including direct supply costs, were not significantly different between RALS and VATS ($6621 vs $6483; P = .784). Median total operating costs and total unit support costs, which are closely correlated to length of stay, were lower in the RALS group. Overall median controllable costs were significantly different between RALS and VATS ($16,352 vs $21,154; P = .025). CONCLUSIONS: A potentially cost-advantageous robotic-assisted pulmonary resection program can be initiated within the context of an existing minimally invasive thoracic surgery program while maintaining good clinical outcomes when compared with traditional VATS. Process-of-care changes associated with RALS may account for decreased costs in this setting.

Associations of Age at Menopause With Postmenopausal Bone Mineral Density and Fracture Risk in Women.

CONTEXT: Menopause before age 45 is a risk factor for fractures, but menopause occurs at age ≥45 in ~90% of women. OBJECTIVE: To determine, in women with menopause at age ≥45, whether (1) years since the final menstrual period (FMP) is more strongly associated with postmenopausal bone mineral density (BMD) than chronological age and (2) lower age at FMP is related to more fractures. DESIGN AND SETTING: The Study of Women's Health Across the Nation, a longitudinal cohort study of the menopause transition (MT). PARTICIPANTS: A diverse cohort of ambulatory women (pre- or early perimenopausal at baseline, with 15 near-annual follow-up assessments). MAIN OUTCOME MEASURES: Postmenopausal lumbar spine (LS) or femoral neck (FN) BMD (n = 1038) and time to fracture (n = 1554). RESULTS: Adjusted for age, body mass index (BMI), cigarette use, alcohol intake, baseline LS or FN BMD, baseline MT stage, and study site using multivariable linear regression, each additional year after the FMP was associated with 0.006 g/cm2 (P < 0.0001) and 0.004 g/cm2 (P < 0.0001) lower postmenopausal LS and FN BMD, respectively. Age was not related to FN BMD independent of years since FMP. In Cox proportional hazards regression, accounting for race/ethnicity, BMI, cigarette use, alcohol intake, prior fracture, diabetes status, exposure to bone-modifying medications/supplements, and study site, the hazard for incident fracture was 5% greater for each 1-year decrement in age at FMP (P = 0.02). CONCLUSIONS: Years since the FMP is more strongly associated with postmenopausal BMD than chronological age, and earlier menopause is associated with more fractures.

Association Between Hyperoxemia and Increased Cell-Free Plasma Hemoglobin During Cardiopulmonary Bypass in Infants and Children.

OBJECTIVES: To determine potential risk factors for severe hemolysis during pediatric cardiopulmonary bypass and examine whether supraphysiologic levels of oxygen and cardiopulmonary bypass duration are associated with hemolysis. DESIGN: Prospective observational study. SETTING: Cardiac ICU in a university-affiliated children's hospital. PATIENTS: Greater than 1 month to less than 18 years old patients undergoing cardiopulmonary bypass for cardiac surgery. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Plasma samples from 100 patients to assess cell-free plasma hemoglobin levels were obtained at start cardiopulmonary bypass, at the end of cardiopulmonary bypass, and 2 and 24 hours after reperfusion. Arterial blood gas samples were obtained before and every 30 minutes during cardiopulmonary bypass. Patient demographics and laboratory data were collected from the electronic medical record. Plasma hemoglobin levels peaked at the end of cardiopulmonary bypass and haptoglobin levels continued to fall throughout all time points. There were 44 patients with severe hemolysis (change in cell-free plasma hemoglobin > 50 mg/dL). Younger age (odds ratio/sd 0.45 [95% CI, 0.25-0.81]) and higher mean Pao2 × cardiopulmonary bypass duration (31.11 [1.46-664.64]) were identified as risk factors for severe hemolysis in multivariable analysis. Severe hemolysis was associated with longer hospital and ICU lengths of stay as well as acute kidney injury. CONCLUSIONS: We observed younger age and the exposure to both oxygen and duration of cardiopulmonary bypass as risk factors for hemolysis. Oxygen delivery through the cardiopulmonary bypass circuit is an easily modifiable risk factor. Its role in the production of reactive oxygen species that could alter the erythrocyte membrane deserves further examination in larger prospective studies.

The relationship between 19-year trends in medication use and changes in physical function among women in the mid-life: A Study of Women's Health Across the Nation pharmacoepidemiology study.

PURPOSE: Medication side effects are a major concern in aging adults who report using an increasing number of medications. The relationship between accumulating medication use and physical function has not been examined in a longitudinal cohort. METHODS: We conducted a longitudinal cohort study using prospectively collected data from the Study of Women's Health Across the Nation (SWAN). Community-dwelling women from five US cities were followed for up to 20 years. The exposure of interest was the number of prescription medications. They were examined as a count variable and then for specific categories of medication. The outcome of interest was physical function measured repeatedly using the short form (SF)-36 physical function (PF) scale. Linear mixed models, using repeated measures of sociodemographics and comorbidities were assessed. RESULTS: 1452 participants qualified for the analyses with a median follow-up of 19.2 years. At baseline, the mean age was 46.5 years and 53.5% reported White race. Fully adjusted models demonstrated a reduction in the SF-36 PF of 0.99 for each additional prescription medication used or a 6.14-point reduction for women reporting more than five medications and an 8.92-point reduction among those reporting more than 10 medications. These results were similar across race and ethnicity. Specific medication categories with a significant and largely negative impact (at least a two-point reduction) on physical component score included beta-blockers, analgesics, glucocorticoids, anticonvulsants, anxiolytics, anticoagulants, and anti-depressants. CONCLUSIONS: There is a moderate association between increasing medication use and decreasing physical function among women transitioning through the mid-life.

Total Vaginal Hysterectomy With Uterosacral Ligament Suspension Compared With Supracervical Hysterectomy With Sacrocervicopexy for Uterovaginal Prolapse.

OBJECTIVE: To compare prolapse recurrence after total vaginal hysterectomy with uterosacral ligament suspension to recurrence after supracervical hysterectomy with mesh sacrocervicopexy for the primary management of uterovaginal prolapse. METHODS: We conducted a retrospective cohort study of women undergoing uterovaginal prolapse repair at an academic center from 2009 to 2019. Women who underwent vaginal hysterectomy with uterosacral ligament suspension or laparoscopic supracervical hysterectomy with mesh sacrocervicopexy were included. The primary outcome was composite prolapse recurrence (prolapse beyond the hymen or retreatment with pessary or surgery). Secondary outcomes included mesh complications, time to recurrence, and overall reoperation for either prolapse recurrence or mesh complication. We used propensity scoring with a 2:1 ratio of sacrocervicopexy to uterosacral suspension. RESULTS: The cohort consisted of 654 patients, of whom 228 (34.9%) underwent uterosacral suspension and 426 (65.1%) underwent sacrocervicopexy. The median follow-up was longer for the sacrocervicopexy group (230 vs 126 days, P<.001) and less than 1 year for both groups. The uterosacral group had a greater proportion of composite prolapse recurrence (14.9% [34/228] vs 8.7% [37/426], P=.02) and retreatment for recurrent prolapse (7.5% [17/228] vs 2.8% [12/426], P=.02). The uterosacral group demonstrated a shorter time to prolapse recurrence on multivariable Cox regression (hazard ratio 3.14, 95% CI 1.90-5.16). There were 14 (3.3%) mesh complications in the sacrocervicopexy group. Overall reoperation was similar between groups (4.8% [11/228] vs 3.8% [16/426], P=.51). CONCLUSION: Total vaginal hysterectomy with uterosacral ligament suspension was associated with higher rate of, and shorter time-to-prolapse recurrence compared with supracervical hysterectomy with mesh sacrocervicopexy.

Two-Layer Compared With One-Layer Vaginal Cuff Closure at the Time of Total Laparoscopic Hysterectomy to Reduce Complications.

OBJECTIVE: To explore whether two-layer laparoscopic vaginal cuff closure at the time of laparoscopic hysterectomy is associated with a lower rate of postoperative complications compared with a standard one-layer cuff closure. METHODS: A retrospective cohort study of total laparoscopic hysterectomies performed by fellowship-trained minimally invasive gynecologic surgeons between 2011 and 2017 was performed. Surgeons sutured the vaginal cuff laparoscopically, either in a two- or one-layer closure. The primary outcome was a composite of total postoperative complications, including all medical and surgical complications within 30 days and vaginal cuff complications within 180 days. Factors known to influence laparoscopic vaginal cuff complications including age, postmenopausal status, body mass index, tobacco use, and immunosuppressant medications were examined and controlled for, while surgeon skill, colpotomy technique, and suture material remained standardized. We conducted statistical analyses including χ2, Fisher exact test, logistic regression, and post hoc power calculations. RESULTS: Of the 2,973 women who underwent total laparoscopic hysterectomies, 40.8% (n=1,213) of vaginal cuffs were closed with a two-layer closure and 59.2% (n=1,760) with a one-layer technique. Two-layer vaginal cuff closure was associated with decreased numbers of total postoperative complications (3.5% vs 5.7%; P<.01). The primary difference stemmed from lower vaginal cuff complications within 180 days (0.9% vs 2.6%; P<.01); no differences in 30-day medical and surgical postoperative complications were observed between the two groups (2.6% vs 3.1%; P=.77). No patients in the two-layer vaginal cuff closure cohort experienced a vaginal cuff dehiscence or mucosal separation compared with 1.0% in the one-layer group (P<.01). Compared with a one-layer closure, a two-layer closure was protective from postoperative complications (adjusted odds ratio 0.38, 95% CI 0.19-0.74). CONCLUSION: Although postoperative complications with laparoscopic hysterectomies are rare, two-layer laparoscopic vaginal cuff closure is associated with lower total postoperative complications compared with a one-layer closure. The difference was primary driven by cuff complications.

Race/ethnic difference in trabecular bone score in midlife women: The Study of Women's Health Across the Nation (SWAN).

There was no difference in Trabecular Bone Score (TBS) comparing White and Black women after adjusting for body mass index (BMI) and diabetes status. Japanese women had lower TBS than White women. Our results diverge from established differences in fracture rates by race/ethnicity. INTRODUCTION: The TBS was developed as an indirect measure of vertebral bone microarchitecture derived from texture analysis of lumbar spine DXA scans. There is little information on race/ethnic differences in TBS. METHODS: We compared TBS in 656 White, 492 Black, and 268 Japanese pre- and early perimenopausal women. We used a beta version of TBS that accounts for tissue thickness using DXA measured soft tissue thickness rather than BMI. The relation between BMI and tissue thickness corrected TBS differed by BMI; we used a three-segment linear spline to adjust for BMI. RESULTS: The women were, on average, 46.5 years of age; 50% were premenopausal. In BMI and diabetes adjusted models, there was no difference in TBS between White and Black women. TBS was modestly (2%) lower in the Japanese women compared to White women, p = 0.04. In a sensitivity analysis, restricting the analysis to those with BMI 24-31 kg/m2, results were similar. CONCLUSIONS: TBS was similar in Black and White women after accounting for tissue thickness and adjusting for BMI, diabetes, and other covariates. The Japanese women had modestly lower TBS. These results diverge from established race/ethnic differences in fracture rates and areal bone mineral density, underscoring the need for further studies.

Effect of a Primary Care-Based Diabetes Education Model on Provider Referrals and Patient Participation.

PURPOSE: The purpose of this study was to evaluate the impact of a primary care (PC)-based delivery model on diabetes self-management education and support (DSMES) referrals and participation. Despite evidence that DSMES is a critical component of diabetes care, referrals and participation remain low. METHODS: PC practices were assigned to the intervention (n = 6) or usual care (n = 6). Intervention practices had direct access to a diabetes educator (DE) and applied patient-centered medical home elements to DSMES delivery. Usual care practices referred patients to traditional hospital-based outpatient DSMES programs. DSMES referrals and participation were examined for patients with diabetes, 18 to 75 years old, presenting to PC over 18 months (n = 4,894) and compared between groups. RESULTS: Compared to the usual care group, a higher percentage of patients in the intervention practices were referred to DSMES (18.4% vs 13.4%; P < .0001), and of those referred, a higher percentage of patients in the intervention practices participated in DSMES (34.9% vs 26.1%; P = .02). Patient-level factors predicting referrals were obesity (odds ratio [OR] = 1.6), higher A1C (OR = 1.4), female (OR = 1.3), and younger age (OR = 0.98). The only patient-level factor that predicted DSMES participation was lower A1C (OR = 0.9). CONCLUSIONS: This study demonstrates the positive influence of a PC-based intervention on DSMES referral and participation. However, modest improvements in DSMES rates, even with targeted efforts to address reported barriers, raise questions as to what is truly needed to drive meaningful change.