A Contemporary View of Menopausal Hormone Therapy.

Enthusiasm for the use of hormones to ameliorate symptoms of perimenopause and menopause has waxed and waned over the years. Both treatment for symptoms and training of women's health care practitioners in the management of menopause have sharply declined since publication of the Women's Health Initiative initial results in 2002. Findings from that trial, which treated a population of older, asymptomatic patients, have been extrapolated over the past 21 years to all estrogen products, all menopausal women, and all delivery mechanisms. Our patients deserve a more nuanced, individualized approach. Conjugated equine estrogens and medroxyprogesterone acetate are no longer the predominant medications or medications of choice available for management of menopausal symptoms. All hormones are not equivalent any more than all antiseizure medications or all antihypertensives are equivalent; they have different pharmacodynamics, duration of action, and affinity for receptors, among other things, all of which translate to different risks and benefits. Consideration of treatment with the right formulation, at the right dose and time, and for the right patient will allow us to recommend safe, effective, and appropriate treatment for people with menopausal symptoms.

Effects of the ARRIVE (A Randomized Trial of Induction Versus Expectant Management) Trial on Elective Induction and Obstetric Outcomes in Term Nulliparous Patients.

OBJECTIVE: To evaluate the effect of publication of the ARRIVE (A Randomized Trial of Induction Versus Expectant Management) trial on perinatal outcomes in singleton, term, nulliparous patients. METHODS: An interrupted time series analysis was performed using clinical data for nulliparous singleton births at 39 weeks of gestation or later at 13 hospitals in the Northwest region of the United States (January 2016-December 2020). A modified Poisson regression was used to model time trends and changes after the ARRIVE trial (August 9, 2018). Outcomes of interest were elective induction, unplanned cesarean births, hypertensive disorders of pregnancy, a composite of perinatal adverse outcomes, and neonatal intensive care unit admissions. RESULTS: The analysis included 28,256 births (15,208 pre-ARRIVE and 13,048 post-ARRIVE). The rate of elective labor induction was 3.6% during the pre-ARRIVE period (January 2016-July 2018) and 10.8% post-ARRIVE (August 2018-December 2020). In the interrupted time series analysis, elective induction increased by 42% (relative risk [RR] 1.42; 95% CI 1.18-1.71) immediately after the ARRIVE trial publication. Thereafter, the trend was unchanged compared with the pre-ARRIVE period. There was no statistically significant change in cesarean birth (RR 0.96; 95% CI 0.89-1.04) or hypertensive disorders of pregnancy (RR 0.91; 95% CI 0.79-1.06) immediately after the trial, and no change in trend. After the ARRIVE trial, there was no immediate change in adverse perinatal outcomes, but a statistically significant increase in trend of adverse perinatal events (1.03; 95% CI 1.01-1.05) when compared with a declining trend observed in the pre-ARRIVE period. CONCLUSION: Publication of the ARRIVE trial was associated with an increase in elective induction, and no change in cesarean birth or hypertensive disorders of pregnancy in singleton nulliparous patients giving birth at 39 weeks or later. There was a flattening of the pre-ARRIVE decreasing trend in perinatal adverse events.

The relationship between heavy menstrual bleeding, iron deficiency, and iron deficiency anemia.

For reproductive-aged women, the symptom of heavy menstrual bleeding is highly prevalent and a major contributor to iron deficiency and its most severe manifestation, iron deficiency anemia. It is recognized that these 2 clinical entities are not only highly prevalent, but their interrelationship is poorly appreciated and frequently normalized by society, healthcare providers, and affected girls and women themselves. Both heavy menstrual bleeding and iron deficiency, with or without anemia, adversely impact quality of life-heavy menstrual bleeding during the episodes of bleeding and iron deficiency on a daily basis. These combined issues adversely affect the lives of reproductive-aged girls and women of all ages, from menarche to menopause, and their often-insidious nature frequently leads to normalization. The effects on cognitive function and the related work and school absenteeism and presenteeism can undermine the efforts and function of women in all walks of life, be they students, educators, employers, or employees. There is also an increasing body of evidence that suggests that iron deficiency, even in early pregnancy, may adversely impact fetal neurodevelopment with enduring effects on a spectrum of cognitive and psychological disorders, critically important evidence that begs the normalization of iron stores in reproductive-aged women. The authors seek to raise individual, societal, and professional awareness of this underappreciated situation in a fashion that leads to meaningful and evidence-based changes in clinical guidance and healthcare policy directed at preventing, screening, diagnosing, and appropriately managing both disorders. This manuscript provides evidence supporting the need for action and describes the elements necessary to address this pervasive set of conditions that not only affect reproductive-aged girls and women but also the lives of children everywhere.

Clinical and Patient Reported Outcomes of Pre- and Postsurgical Treatment of Symptomatic Uterine Leiomyomas: A 12-Month Follow-up Review of TRUST, a Surgical Randomized Clinical Trial Comparing Laparoscopic Radiofrequency Ablation and Myomectomy.

STUDY OBJECTIVE: The objective of this study was to determine the efficacy, safety, and healthcare resource use of laparoscopic radiofrequency ablation (LAP-RFA) compared with myomectomy in patients with symptomatic uterine leiomyomas (ULs). DESIGN: This was a secondary analysis of the original postmarket randomized, multicenter, longitudinal, comparative TRUST (Treatment Results of Uterine Sparing Technologies) United States trial in patients with symptomatic ULs. After the procedure, subjects were followed over a 12-month period. SETTING: Multicenter trial, including hospitals with or without an academic affiliation, surgery centers, and fertility centers performing outpatient procedures for uterine myomas. PARTICIPANTS: A total of 57 patients were randomized to either LAP-RFA (n = 30) or myomectomy (n = 27). INTERVENTIONS: LAP-RFA or myomectomy (laparoscopic or abdominal). MEASUREMENTS AND MAIN RESULTS: The main outcome measures of this study were part of the secondary outcomes of the original TRUST trial. The primary outcome of this study was the reduction of UL symptoms and the improvement in patient-reported outcomes scores over time. Secondary outcomes included postprocedure hospitalization, length of stay, complications, reinterventions, and recovery time. There was a significant improvement in UL symptoms at 3 and 12 months after the procedure within each treatment group, and these improvements were similar between treatment groups. There was a significant reduction in UL symptoms per month between baseline and 12-months after the procedure for both LAP-RFA and myomectomy of 72% and 85%, respectively. A significant improvement was seen in all patient-reported outcomes scores over time for both groups. At 3 and 12 months after the procedure, the percentages of patients who were hospitalized in the LAP-RFA group were 74% and 49% lower than those of patients in the laparoscopic myomectomy group, respectively, with the 3-month difference being statistically significant. The length of hospital stay was significantly shorter in the LAP-RFA group compared with the myomectomy group (8.0 ± 5.7 hours vs 18.8 ± 14.6 hours; p < .05). Doctors recommended taking significantly less time off before returning to work for the patients in the LAP-RFA group compared with those in the myomectomy group (10.3 ± 5.1 days vs 14.5 ± 5.4 days; p < .05). The total number of days until back to normal activity was significantly lower in the LAP-RFA group compared with the myomectomy group (16.3 ± 15.2 days vs 26.5 ± 15.9 days; p < .05). CONCLUSION: The results from this 12-month follow-up study suggest that LAP-RFA is a safe, effective, uterine-sparing alternative to laparoscopic myomectomy in the treatment of ULs. These data points build on previously published studies showing that LAP-RFA has lower healthcare resource use overall, including lower postprocedure hospitalization rate and shorter length of stay. In clinical practice, LAP-RFA is a promising treatment approach to ULs for women.

Uterine Fibroids in Black Women: A Race-Stratified Subgroup Analysis of Treatment Outcomes After Laparoscopic Radiofrequency Ablation.

Background: The disease and treatment burden of uterine fibroids (UF) in Black women is substantially greater compared with other racial groups, with higher rates of complications and poorer outcomes with both hysterectomy and myomectomy. The inequities in the access Black women have to minimally invasive routes of surgery contribute to their burden of illness. Laparoscopic radiofrequency ablation (LAP-RFA) is a minimally invasive, safe, and effective uterine-sparing treatment option. Methods: This subgroup analysis of the LAP-RFA Pivotal Trial stratified outcomes by race comparing White women (n = 28, 21%) versus Black women (n = 46, 34%). Results: At baseline, Black women had more fibroids on average (7.3 vs. 3.7; P ≤ 0.001), a greater symptom severity score (SSS) (P ≤ 0.001), and a lower health-related quality of life (HRQoL) score (P = 0.005) than White women. At 36 months post-treatment with LAP-RFA, the statistical differences that existed with baseline SSS and HRQoL score were eliminated between Black and White women. Menstrual blood loss (140.1 mL vs. 127.02 mL; P = 0.44) and mean fibroid volume reduction (47.5 cm3 vs. 36.0 cm3; P = 0.17) were similar between Black and White women at 12 months. Although not statistically significant, the intraoperative total blood loss and uterine blood loss was lower in Black women than White women, despite greater operative time (160 minutes vs. 137 minutes; P = 0.09). Conclusions: These results are promising in providing an alternative uterine-sparing option for Black women and may help to provide a minimally invasive option that can address some of the racial inequities in care for Black women with UF.

Comparison of Psychological and Physiological Stress in NICU Nurses: Effects of Unit Design and Shift.

BACKGROUND: Effects of unit design and shift worked on stress in neonatal intensive care unit (NICU) nurses have not been fully studied. PURPOSE: To compare stress in NICU nurses who work in single-family room (SFR) or open bay (OBY) units and on nonrotating day or night shift. METHODS: Full-time registered nurses (RNs) (n = 72) from a 42-bed SFR and a 131-bed OBY NICU participated in this comparative cross-sectional study. The Nurse Stress Scale (NSS) and within-shift repeated salivary cortisol levels were used to measure stress. The relationship between NSS score and salivary cortisol level was examined using multiple linear regression. Salivary cortisol levels of day versus night shift were compared with mixed-effects linear models. RESULTS: NSS scores were similar for SFR and OBY units (P = .672) and day versus night shift (P = .606). Changes in cortisol level over time (P = .764) and final cortisol level (P = .883) for SFR versus OBY were not significantly different after controlling for shift. Salivary cortisol level of day-shift nurses decreased significantly over time compared with night-shift nurses (P < .001). The final cortisol level was significantly higher for night-shift compared with day-shift nurses (P < .001). IMPLICATIONS FOR PRACTICE: Psychological (NSS) and physiologic (salivary cortisol) stress of NICU nurses is similar in established SFR and OBY units. Cortisol levels are higher at the end of shift in nurses who work night shift and may reflect increased physiologic stress. IMPLICATIONS FOR RESEARCH: Strategies are needed for reducing stress in NICU nurses who work night shift.

Evolving the Preconception Health Framework: A Call for Reproductive and Sexual Health Equity.

Over the past decade, increasing attention has been paid to intervening in individuals' health in the "preconception" period as an approach to optimizing pregnancy outcomes. Increasing attention to the structural and social determinants of health and to the need to prioritize reproductive autonomy has underscored the need to evolve the preconception health framework to center race equity and to engage with the historical and social context in which reproduction and reproductive health care occur. In this commentary, we describe the results of a meeting with a multidisciplinary group of maternal and child health experts, reproductive health researchers and practitioners, and Reproductive Justice leaders to define a new approach for clinical and public health systems to engage with the health of nonpregnant people. We describe a novel "Reproductive and Sexual Health Equity" framework, defined as an approach to comprehensively meet people's reproductive and sexual health needs, with explicit attention to structural influences on health and health care and grounded in a desire to achieve the highest level of health for all people and address inequities in health outcomes. Principles of the framework include centering the needs of and redistributing power to communities, having clinical and public health systems acknowledge historical and ongoing harms related to reproductive and sexual health, and addressing root causes of inequities. We conclude with a call to action for a multisectoral effort centered in equity to advance reproductive and sexual health across the reproductive life course.

Path to leadership in medicine: Advocacy and evidence-based medicine.

Physicians are experiencing overwhelming demands to generate revenue and complete ever-increasing administrative tasks. Whether employed by large health systems, academic centers or still struggling in small private practices, the autonomy so valued by medical professionals, and our ability to influence policies impacting our patients and the public, has diminished. In order to regain the joy in practicing medicine and overcome the sense of "burn-out" and frustration so many of us experience, it is essential to dedicate ourselves to becoming leaders in our communities, in our institutions and in our medical schools. We must apply the triad of evidence-based medicine - the data derived from randomized clinical trials, our learned experience, and our patients' values - to become leaders in the path towards reasoned public policy and institutional procedures that improve the care for individual patients and the community. Through advocacy and leadership, we can re-engage with the passion that drove us to our profession and renew our commitment to the patients we serve. The energy and time required for these activities will be more than repaid with joy and passion in our daily work and a sense of purpose in our lives.

Workplace Harassment and Discrimination in Gynecology: Results of the AAGL Member Survey.

STUDY OBJECTIVE: To characterize workplace and sexual harassment and discrimination among physicians in gynecology. DESIGN: A beta-tested Internet survey was distributed by e-mail using the REDCap platform. All responses were anonymous. SETTING: The survey was distributed to the 7026 physician members of an international gynecologic society (AAGL), including faculty and trainees. PATIENTS: Not applicable. INTERVENTIONS: The survey was distributed on 3 occasions between July and September 2018. The survey contained questions on demographics, attitudes, experiences, and sequelae regarding harassment and discrimination in the workplace. Frequency distributions and nonparametric tests were performed to determine the percentages and types of harassment and discrimination among respondents. MEASUREMENTS AND MAIN RESULTS: A total of 907 physicians responded, including 603 US physicians and 304 non-US physicians; 59% identified as female and 40% as male, and 20% were trainees. Females were more likely than males to think the #MeToo movement was "justified and overdue" (p < .05), independent of age or trainee status. More females than males reported experiencing workplace discrimination (67% vs 39%; p < .001); gender-based discrimination was the most common basis for both. Females indicated decreased self-confidence and lower salary; males indicated fewer employment opportunities and lower patient volume. Harassment was reported by more females than males (53% vs 17%; p < .001), including sexual harassment (39% vs 11%, p <.05). Most experienced loss of self-confidence, felt the offender was in a position of power, and did not report the incident, often due to fear of reprisal. Multiple respondents experienced workplace-related sexual assault. CONCLUSION: Workplace harassment and discrimination are commonly experienced by female and male gynecologists and are usually related to a power differential. Improvements must be made in the workplace environment to achieve equity and a safe workplace free of harassment and discrimination.

Implementation of the Alliance for Innovation on Maternal Health Program to Reduce Maternal Mortality in Malawi.

OBJECTIVE: To evaluate maternal mortality and changes in the culture of safety before and after the implementation of the Alliance for Innovation on Maternal Health (AIM) Malawi program. METHODS: This was a prospective cohort study at a central hospital and a district health center in Malawi from March 2016 to November 2017. The AIM Malawi program included classroom didactics on obstetric hemorrhage, teamwork protocols, skills laboratory activities, and simulation training. The time periods of comparison were preintervention, education period, and postintervention. Hospital birth paper records were used to collect data on patient demographics and obstetric and neonatal information. The Hospital Survey of Patient Safety was used to measure the culture of safety before and after the program. RESULTS: We trained 128 participants. In the postintervention period, 16 procedural interventions were performed to manage postpartum hemorrhage, including B-lynch sutures (n=7), condom balloon catheter (n=5), nonpneumatic antishock garment (n=3), and uterine artery ligation (n=1). There was a significant increase in the use of B-lynch sutures for the management of uterine atony in the postintervention compared with preintervention period (P=.014). In the postintervention period, the rate of maternal mortality from obstetric hemorrhage decreased significantly from 1.2% to 0.2% (P=.02), a relative decrease of 82.1% from the preintervention rate. Hospital safety culture scores improved significantly from baseline in four out of five domains after the AIM Malawi training. CONCLUSION: After implementation of the AIM Malawi program, we found an increased use of postpartum hemorrhage procedural interventions, a decreased rate of maternal mortality and an increase in Hospital Survey of Patient Safety composite safety scores. The AIM Malawi program may be an effective framework for adaptation to improve maternal mortality in a low-resource setting.

Consensus Guidelines for Facilities Performing Outpatient Procedures: Evidence Over Ideology.

In policy and law, regulation of abortion is frequently treated differently from other health services. The safety of abortion is similar to that of other types of office- and clinic-based procedures, and facility requirements should be based on assuring high-quality, safe performance of all such procedures. False concerns for patient safety are being used as a justification for promoting regulations that specifically target abortion. The Project on Facility Guidelines for the Safe Performance of Primary Care and Gynecology Procedures in Offices and Clinics was undertaken by clinicians, consumers, and representatives from accrediting bodies to review the available evidence and guidelines that inform safe delivery of outpatient care. Our overall objective was to develop evidence-informed consensus guidelines to promote health care quality, safety, and accessibility. Our consensus determined that requiring facilities performing office-based procedures, including abortion, to meet standards beyond those currently in effect for all general medical offices and clinics is unjustified based on an analysis of available evidence. No safety concerns were identified.

The Maternal Quality Improvement Program: A Clinical Data-Driven National Registry for Maternity Care.

Advancing the quality and safety of maternity care should be data-driven. Defining a standard set of clinical data elements, across electronic health record platforms and facilities, could accelerate performance measurement, benchmarking, and identification of better practices. In 2014, the American College of Obstetricians and Gynecologists and the American Society of Anesthesiologists launched the Maternal Quality Improvement Program, a data-driven national clinical registry for maternity care. Having an agreed-on set of discrete data elements related to labor and delivery will set the stage for analysis of this care. Through the use of clinical performance measures and data quality metrics, the Maternal Quality Improvement Program will provide an opportunity for health care providers to better understand the overall quality and safety of the maternity care provided within their institution.