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.

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.

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.

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.

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.

Intraoperative Remifentanil Infusion and Postoperative Pain Outcomes After Cardiac Surgery-Results from Secondary Analysis of a Randomized, Open-Label Clinical Trial.

DESIGN: Report of secondary pain outcomes from a prospective, randomized, open-label clinical trial that compared remifentanil and fentanyl on perioperative hyperglycemic response in cardiac surgery. SETTING: Single institution, tertiary university hospital. PARTICIPANTS: The study comprised 116 adult elective cardiac surgical patients. INTERVENTIONS: Participants were randomly assigned to receive either intermittent fentanyl boluses (F) or continuous remifentanil infusion (R) intraoperatively. MEASUREMENTS AND MAIN RESULTS: Postoperative pain was evaluated with pain scores every 6 hours for 48 hours. Pain threshold to mechanical stimuli was measured around the sternotomy incision at 48 and 96 hours. The development of chronic pain was assessed using the numeric rating scale at 1, 3, 6, and 12 months after discharge. The final analysis included 106 patients. Pain scores and wound hyperalgesia were not significantly different postoperatively between the groups. The incidence of chronic pain at 3 months was comparable in both groups (61% in group F v 58% in group R; p = 0.79). Pain of more-than-mild degree was seen in 13 (32%) patients in group F and 8 (19%) in group R (p = 0.25) at 3 months. Median pain scores were not significantly different between the groups at 1, 3, 6, and 12 months after discharge from the hospital. CONCLUSIONS: The present study's findings suggested that intraoperative remifentanil infusion does not significantly worsen pain outcomes in patients undergoing elective cardiac surgery.

30-Day unanticipated healthcare encounters after prolapse surgery: impact of same day discharge.

BACKGROUND: Same-day discharge is becoming increasingly common in gynecologic surgery; however, data are limited for frequency, setting, and severity of unanticipated healthcare visits for women who are discharged on the day of surgery after major prolapse repair. OBJECTIVE: The purpose of this study was to evaluate whether discharge on the day of surgery is associated with increased 30-day unanticipated healthcare encounters after major pelvic organ prolapse surgery compared with discharge on or after postoperative day 1. STUDY DESIGN: This is a retrospective analysis of women who underwent pelvic organ prolapse surgery by 8 female pelvic medicine and reconstructive surgery surgeons from January 2016 to October 2017. Unanticipated healthcare encounter was a composite variable of any visit to the office, emergency department, or hospital readmission. Number of visits, visit diagnoses, and complication severity (Clavien-Dindo classification) were compared by day of discharge with the use of χ2 tests. Multivariable analyses were performed. RESULTS: Of 405 women, 258 (63.7%) were discharged on the day of surgery, and 147 (36.3%) were discharged on postoperative day 1 or later. Mean age was 66±11 years, body mass index was 27.9±4.8 kg/m2. Most had stage III prolapse (n=273; 67.4%). Procedures included laparoscopic or robotic sacrocolpopexy, (n=163; 40.2%), vaginal apical suspensions (n=115; 28.4%), obliterative (n=105; 25.9%), and concomitant hysterectomy (n=229; 56.5%). There was no increase in the number of women with at least 1 unanticipated healthcare encounter within 30 days of surgery, based on discharge on the day of surgery compared with postoperative day 1 (24.0% vs 26.5%; P=.572). The majority of visits occurred in the office (17.8% vs 19.0%; P=.760). There was no increase in 30-day readmissions (3.5% vs 4.8%; P=.527). The most common visit diagnosis was pain and accounted for 31.5% of all visits, followed by urologic and gastrointestinal symptoms. Diagnoses and complication severity did not vary by day of discharge, except that women who were discharged on the day of surgery were more likely to have a superficial wound separation (11.3% vs 0%; P=.011) and less likely to experience grade II complications (7.4% vs 15.6%, P=.009). Few women had >1 unscheduled visit, and rates were similar between the 2 groups (6.2% vs 6.8%; P=.810). On multivariable regression, younger women (adjusted odds ratio, 1.03; 95% confidence interval, 1.001-1.05), those with lower body mass index (adjusted odds ratio, 1.07; 95% confidence interval, 1.13-1.01), and higher initial postanesthesia recovery unit pain scores (adjusted odds ratio, 1.11; 95% confidence interval, 1.02-1.21) were more likely to have an unanticipated healthcare encounter. Pain complaints were evaluated most often in the office compared with the emergency department (41.1% vs 13.0%); medical complications such as cardiac (15.6% vs 0%) and respiratory (6.5% vs 0%) were more likely to be evaluated in the emergency department. Higher grade complications (II/III) were more likely to visit the emergence department (78.2% vs 27.1%; P<.0001). CONCLUSION: Same-day discharge after prolapse surgery did not result in an increase in 30-day unanticipated healthcare encounters.

Sleep medications and sleep disturbances across middle aged pre- or peri-menopausal women of different race and ethnicities: A SWAN pharmacoepidemiology cohort study.

PURPOSE: Sleep disturbances are common, particularly in middle aged women. Prescription medications for this indication are increasingly used, despite uncertain safety. This study assessed prescription medication use for sleep among a cohort of women with and without sleep disturbances. METHODS: We examined reports of sleep disturbance and sleep medication use among pre- and early peri-menopausal womenassessed annually or biennially since 1996. Women self-reported medications at visits, and we identified medications that have been used primarily for sleep disturbances. They reported on difficulties falling and staying asleep, and early morning wakening. Sleep medication use across 20 years of follow-up was examined for all women and by race/ethnicity. Women who reported data for both sleep disturbance and sleep medication use were included in the analyses.. RESULTS: Among participants in a cohort of 3302 women who were enrolled prior to their menopause transition, 3082 women were included in the analytic sample and 2531 (82%) reported sleep disturbances. They were more likely to endorse higher anxiety and pain scores and more comorbid conditions than women without sleep disturbances. Baseline characteristics were similar among women who did and did not use sleep medications. Among women reporting a sleep disturbance at baseline, 2.5% reported sleep medication use, increasing to 8% over 20 years. However, the proportion of women reporting sleep medication use who did not report a sleep disturbance remained low, approximately 1% to 2% over the entire follow-up. Increases in sleep medication use was observed across women of all race/ethnicities. CONCLUSIONS: The use of sleep medications among women reporting sleep disturbance grew over the last 20 years. Growth was observed across women of all race/ethnicities.

Variables associated with an inability to learn clean intermittent self-catheterization after urogynecologic surgery.

INTRODUCTION AND HYPOTHESIS: Post-operative urinary retention is a common problem affecting close to half of all women undergoing pelvic reconstructive surgery. This was an exploratory analysis that was aimed at identifying factors associated with an inability to learn clean intermittent self-catheterization (CISC) after a failed post-operative retrograde voiding trial (RGVT). METHODS: We performed a retrospective case-control study of women who underwent pelvic organ prolapse or urinary incontinence surgery within a single division from 2016 to 2018. We compared women who could learn CISC with those unable to learn and discharged home with an indwelling catheter (IC). Analyses were carried out using Fisher's exact test, the Mann-Whitney U test, the Chi-squared test, and the t test with logistic regression. RESULTS: Of the 202 women who failed their RGVT, 134 (66.3%) were able to learn CISC and 68 (33.7%) were not. Older age, urinary incontinence, diabetes and colpectomy/colpocleisis were associated with an inability to learn CISC (p < 0.05). Women with an IC were more likely to have an office visit related to catheter care (65.7% vs 5.2%, p < 0.001). A UTI within 30 days of surgery was more common with CISC (16.4% vs 6.0%, p = 0.037). In a multivariate logistic regression model, each increasing year of age was associated with a 1.036-fold decrease in the ability to learn CISC (aOR 1.036, 95% CI 1.002-1.071; p = 0.04). CONCLUSIONS: Increasing age was the only variable identified on multivariate logistic regression as a risk factor for failure to learn CISC. Further studies are needed to identify barriers to learning post-operative self-catheterization.

Implementation of a urogynecology-specific enhanced recovery after surgery (ERAS) pathway.

OBJECTIVE: Enhanced recovery after surgery protocols were developed for colorectal surgery to hasten postoperative recovery. Variations of the protocol are being adopted for gynecological procedures despite limited population and procedure-specific outcome data. Our objective was to evaluate whether implementation of an enhanced recovery after surgery pathway would facilitate reduced length of admission in a urogynecology population. MATERIALS AND METHODS: In this retrospective analysis of patients undergoing pelvic floor reconstructive surgery by 7 female pelvic medicine and reconstructive surgeons, we compared same-day discharge, length of admission and postoperative complications before and after implementation of an enhanced recovery after surgery pathway at a tertiary care hospital. Groups were compared using χ2 and Student t tests. Candidate variables that could have an impact on patient outcomes with P < .2 were included in multivariable logistic regression models. Satisfaction with surgical experience was assessed using a phone-administered questionnaire the day after discharge. RESULTS: Mean age and body mass index of 258 women (137 before enhanced recovery after surgery and 121 enhanced recovery after surgery) were 65.5 ± 11.3 years and 28.2 ± 5.0 kg/m2. The most common diagnosis was pelvic organ prolapse (n = 242, 93.8%) including stage III pelvic organ prolapse (n = 61, 65.1%). Apical suspension procedures included 58 transvaginal (25.1%), 112 laparoscopic/robotic (48.8%), and 61 obliterative (26.4%). Hysterectomy was performed in 57.4% of women. Demographic and surgical procedures were similar in both groups. Compared with before enhanced recovery after surgery, the enhanced recovery after surgery group had a higher proportion of same-day discharge (25.9% vs 91.7%, P < .001) and a 13.8 hour shorter duration of stay (25.9 ± 13.5 vs 12.1 ± 11.2 hours, P <.001). Operative and postsurgical recovery room times were similar (2.6 ± 0.8 vs 2.6 ± 0.9 hours, P =.955; 3.7 ± 2.1 vs 3.6 ± 2.2 hours, P = .879). Women in the enhanced recovery after surgery group were more likely to be discharged using a urethral catheter (57.9% enhanced recovery after surgery vs 25.4% before enhanced recovery after surgery, P = .005). There were no group differences in total 30 day postoperative complications overall and for the following categories: urinary tract infections, emergency room visits, unanticipated office visits, and return to the operating room. However, enhanced recovery after surgery patients had higher 30 day hospital readmission rates (n = 8, 6.7% vs n = 2, 1.5%, P = .048). Patients before enhanced recovery after surgery were readmitted for myocardial infarction and chest pain. Enhanced recovery after surgery patients were admitted for weakness, chest pain, hyponatremia, wound complications, nausea/ileus, and ureteral obstruction. Three enhanced recovery after surgery patients returned to the operating room for ureteral obstruction (n = 1), incisional hernia (n = 1), and vaginal cuff bleeding (n = 1). Enhanced recovery after surgery patients also had more postoperative nursing phone notes (2.6 ± 1.7 vs 2.1 ± 1.4, P = .030). On multivariable logistic regressions adjusting for age and operative time, same-day discharge was more likely in the enhanced recovery after surgery group (odds ratio, 32.73, 95% confidence interval [15.23-70.12]), while the odds of postoperative complications and emergency room visits were no different. After adjusting for age, operative time, and type of prolapse surgery, readmission was more likely in the enhanced recovery after surgery group (odds ratio, 32.5, 95% confidence interval [1.1-28.1]). In the enhanced recovery after surgery group, patient satisfaction (n = 77 of 121) was reported as very good or excellent by 86.7% for pain control, 89.6% for surgery preparedness, and 93.5% for overall surgical experience; 89.6% did not recall any postoperative nausea during recovery. CONCLUSION: Enhanced recovery after surgery implementation in a urogynecology population resulted in a greater proportion of same-day discharge and high patient satisfaction but with slightly increased hospital readmissions within 30 days.

Prospective Study of the Impact of Liver Biopsy Core Size on Specimen Adequacy and Procedural Complications.

OBJECTIVE: An American Association for the Study of Liver Diseases (AASLD) consensus document stressed the importance of obtaining sufficient liver biopsy specimens to minimize sampling errors. Many centers continue to use smaller-diameter core systems to minimize perceived complication risks. The objective of this study was to assess the impact of core gauge (18- vs 16-gauge) on specimen adequacy and procedural complications. SUBJECTS AND METHODS: One hundred fifty patients referred for liver biopsy were randomized to undergo 16- or 18-gauge ultrasound (US)-guided core biopsy. Hemorrhage was qualitatively evaluated, and pain was assessed using a 10-point rating scale. The length and number of portal tracts per specimen were assessed. On the basis of the AASLD guidelines, specimen adequacy was defined as 11 or more portal tracts. Differences in pathology metrics and pain scoring were assessed using chi-square and linear regression models. RESULTS: No significant hemorrhage occurred in either group, and there was no difference in postbiopsy pain scores. The mean specimen length obtained with 16-gauge needles was less than that obtained with 18-gauge needles (1.7 vs 1.9 cm, p = 0.03). The mean number of portal tracts obtained with 16-gauge biopsies was greater than obtained with 18-gauge systems (14 vs 13, p = 0.03); 85% of 16-gauge biopsy specimens and 80% of 18-gauge biopsy specimens were adequate on the basis of the AASLD criteria, although this difference was not statistically significant. CONCLUSION: US-guided 18- and 16-gauge core biopsies are similarly safe. A large percentage of 18- or 16-gauge specimens are inadequate when AASLD quality control adequacy thresholds are applied, and specimen adequacy is not significantly affected by biopsy gauge.

Effects of analgesics on bone mineral density: A longitudinal analysis of the prospective SWAN cohort with three-group matching weights.

PURPOSE: To examine the effects of analgesics on bone mineral density (BMD), which have not been examined in a longitudinal study with multiple measurements. METHODS: We investigated changes in BMD associated with new use of analgesics in a prospective longitudinal cohort of mid-life women. BMD and medication use were measured annually. We compared BMD among new users of acetaminophen, NSAIDs, and opioids. Adjustment for baseline covariates was conducted through propensity score matching weights. On-treatment analysis was conducted with inverse probability of censoring weights. Analysis based on the initial treatment group was also conducted to provide insights into selection bias. Repeated BMD measurements were examined with generalized estimating equations. RESULTS: We identified 71 acetaminophen new users, 659 NSAID new users, and 84 opioid new users among 2365 participants. In the on-treatment analysis, the opioid group in comparison to the acetaminophen group had an additional average BMD decline of -0.06% [-1.24, 1.11] per year in the spine and -0.45% [-1.51, 0.61] per year in the femoral neck. BMD mean trajectories over time suggested a fifth-year decline in the opioid persistent users compared with other 2 groups. In the initial treatment group analysis, all 3 groups showed similar trajectories. CONCLUSION: The BMD decline over time was similar among the 3 groups. However, 5 years of continuous opioid use may be associated with a greater BMD decline than 5 years on other analgesics. Further studies examining the relationship between very long-term persistent opioid use and BMD are warranted.

Optimal Oblique Radiographs to Identify Fifth Carpometacarpal Dorsal Subluxations: A Cadaveric Study.

PURPOSE: Carpometacarpal (CMC) joint subluxations of the fifth finger are rare injuries and are notoriously difficult to diagnose due to severe swelling and overlapping of bones on radiographs. Various radiographic studies have been suggested to identify these injuries. We hypothesize that there will be no difference between various oblique radiographs for detection of a fifth finger CMC subluxation. METHODS: Using 4 cadaveric specimens, we took radiographs at various angles (0°, 30°, 45°, and 60°) with the fifth metacarpal in anatomic position, subluxated 25% and 50% dorsally. Radiology and orthopedic residents, fellows, and attending physicians viewed each image to determine whether a subluxation was present. Data were analyzed using area under the receiver operating curve, sensitivity, and specificity. RESULTS: A total of 36 responses were obtained from 9 radiologists (4 residents, 3 fellows, 2 attendings) and 27 orthopedic surgeons (16 residents, 8 fellows, 3 attendings). Radiographs taken at 60° were more sensitive and specific (Sn 85, Sp 60) than at 0° (Sn 64, Sp 33), 30° (Sn 84, Sp 47), or 45° (Sn 80, Sp 49). Area under the receiver operating curve was also higher for 60° (0.87) than 0° (0.59), 30° (0.75), and 45° (0.75). CONCLUSIONS: Sensitivity, specificity, and area under the receiver operating curve were highest for 60° radiographs. We recommend obtaining radiographs of the hand in 60° of pronation from the lateral if there is suspicion for a fifth CMC subluxation or dislocation. CLINICAL RELEVANCE: This study suggests a simple radiographic view to enhance the diagnosis of fifth CMC subluxations.

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.

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.

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.

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.

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.