Final Months Research Articles

An almanac of pandemonium

A New Year had started; a year projected to have many good changes and new beginnings for me. I was into the final months of my radiation oncology residency at a busy tertiary care centre with a dedicated cancer-care facility, with great plans of a much-needed break after my exams, world travel, and subsequently more learning in the later months of the year. Being in a trans-Atlantic relationship for 7 years, during the entirety of which I had been working in demanding departments like oncology and intensive care, our share of holding hands was limited to a few days in a year, and I had started this new year with those.

When a Peripartum Cardiomyopathy Patient Hides Various and Serious Risk Factors for Recurrent and Fatal Thromboembolic Events Even Under Well-Conducted Oral Anticoagulation

Peripartum cardiomyopathy (PPCM) is a rare cause of heart failure that occurs during the final month of pregnancy through about five months after delivery, without any other known cause, and it increases the risk of thromboembolic events by many folds. A 38-year-old female with a history of peripartum dilated cardiomyopathy was admitted to our hospital, one month after a cesarean section, for severe breathlessness. Examination revealed signs of global heart failure and right deep vein thrombosis. Pulmonary CT angiography revealed pulmonary embolism of the right pulmonary artery. The patient was treated by oral anticoagulation with acenocoumarol with all international normalized ratio (INR) values within the target range (2-3). One month later, she was admitted to the emergency department with acute dyspnea and superior vena cava syndrome. Thoracic CT angiogram showed bilateral pulmonary emboli associated with an extensive deep vein thrombosis of both internal jugular veins, sigmoid sinuses, subclavian veins, innominate venous trunks, and the origin of the superior vena cava without any lesion suspected of malignancy. The thrombophilia screen performed six weeks after the suspension of vitamin K antagonists (VKAs) revealed severe deficiencies of protein C and protein S. In this report, we present the first case of recurrence of fatal thromboembolic events under well-conducted oral anticoagulation in a patient with PPCM associated with severe protein C and protein S deficiencies.

University students’ use of motivational regulation during one semester

This study examined the interplay between university students' trajectories of motivational regulation and autonomous motivation across one semester, exploring both between and within person components. Participants (N = 193) from one large class reported motivation in two-week intervals over the course of one semester. Bivariate latent curve models with structured residuals revealed rates of change in motivational regulation and autonomous motivation were not linear, declining across the first ten weeks of the semester then bouncing back in the final month. Between-person effects of individual change demonstrated mirroring relationships of latent intercepts and slopes across the semester. Within-person findings revealed that autonomous motivation was a negative predictor of future motivation regulation. Students' grade point average only predicted students’ beginning level of motivational regulation. It appears that students with higher states of autonomous motivation view motivation regulation as unnecessary or even a potential threat to their learning pleasure and satisfaction.

Factors influencing specialty choice and the effect of recall bias on findings from Irish medical graduates: a cross-sectional, longitudinal study

BackgroundDespite being a vital part of medical workforce planning and development, how medical students and graduates choose their career specialty is still not well understood. This study aimed to identify the factors medical graduates consider important influences in their choice of specialty after their first year of practice, and to test the validity of relying on respondent recall to measure changes in specialty choice.MethodsThe baseline survey was administered online to all final year students in Ireland’s six medical schools. Those who consented to follow-up (n = 483) were surveyed 18 months later (June 2018), during the final month of first year of practice.ResultsThe baseline survey had a 67% (n = 483) response rate. At the follow-up survey, (n = 232, 48% response rate) the top specialty choices were: Medicine, n = 54 (26%); Surgery, n = 34 (16%); General Practice, n = 28 (13%); Anaesthesia, n = 16 (8%) and Paediatrics, n = 14 (7%). Of the 49 respondents (28%) reporting a change of specialty since baseline, 13 (27%) selected the same specialty in both surveys; of the 121 (69%) reporting no change, 22 (18%) selected a different specialty at follow-up.Over 90% of respondents rated as ‘important or ‘very important’: ‘Own aptitude’, ‘Work-life balance’ and ‘What I really want to do’. Over 75% rated as ‘not at all’, or ‘not very important’ ‘Current financial debt’ and ‘Inclinations before medical school’.When adjusted for sex and age, compared with Medicine, General Practice rated as more important: continuity of patient care (RRR 3.20 CI(1.59–6.41), p = 0.001); working hours/conditions (RRR 4.61 CI(1.03–20.60), p = 0.045) and a career that fit their domestic circumstances (RRR 3.19 CI(1.27–8.02), p = 0.014). Those choosing Surgery rated as less important: patient contact (RRR 0.56 CI(0.33–0.95), p = 0.033) and working hours/conditions (RRR 0.55 CI(0.31–0.96), p = 0.035).ConclusionsThe different demographic and motivational profiles by specialty choice are consistent with other studies suggesting a distinct profile for doctors intending to enter General Practice. In addition, our results suggest longitudinal study designs guard against recall bias and so provide more robust medical workforce models to inform and direct recruitment drives and interventions in future medical workforce planning.

Pentecostal preaching and prophetic politics: when the ‘End’ really does justify the means

Alongside the ferocious debates in the final months before the 2016 EU Referendum, some Pentecostal Premillennialists throughout Ulster were conducting their own prophetico-politico-religious crusades. Yet unlike the Leave/Remain campaigns, which used apocalyptic language in a metaphorical fashion, these Protestant preachers constructed an ‘enchantment tale’ aimed at delaying a very real, and catastrophic, ‘End.’ This paper focuses upon three pastors who used their pulpits to rally support for the Brexit campaign. It suggests that the clergymen’s justification of political activism as biblically based, prophetically inspired and divinely endowed points to what happens when political ideas about national ‘well-being’ become ‘enchanted’ by biblical language, and devotees become ‘semiotically aroused’ by what they hear. The rhetoric of these religious leaders also illustrates how tightly the language of the apocalypse is woven into the historical fabric of Northern Irish politics. Finally, this study argues that their activities eclipse some of the ways in which local politicians and clergy continue to manipulate religious vocabulary, to evoke a politically productive affective response in their audiences.

The RESPECT study: a feasibility randomised controlled trial of a sexual health promotion intervention for people with serious mental illness in community mental health services in the UK

BackgroundPeople with serious mental illness (SMI) have sexual health needs but there is little evidence to inform effective interventions to address them. In fact, there are few studies that have addressed this topic for people with SMI outside USA and Brazil. Therefore, the aim of the study was to establish the acceptability and feasibility of a trial of a sexual health promotion intervention for people with SMI in the UK.MethodThe RESPECT study was a two-armed randomised controlled, open feasibility trial (RCT) comparing Sexual health promotion intervention (3 individual sessions of 1 h) (I) or treatment as usual (TAU) for adults aged 18 or over, with SMI, within community mental health services in four UK cities. The main outcome of interest was the percentage who consented to participate, and retained in each arm of the trial, retention for the intervention, and completeness of data collection. A nested qualitative study obtained the views of participants regarding the acceptability of the study using individual telephone interviews conducted by lived experience researchers.ResultsOf a target sample of 100, a total of 72 people were enrolled in the trial over 12 months. Recruitment in the initial months was low and so an extension was granted. However this extension meant that the later recruited participants would only be followed up to the 3 month point. There was good retention in the intervention and the study as a whole; 77.8% of those allocated to intervention (n = 28) received it. At three months, 81.9% (30 I; 29 TAU) and at 6 months, 76.3% (13 I and 16 TAU) completed the follow-up data collection. No adverse events were reported. There was good completeness of the data. The sexual health outcomes for the intervention group changed in favour of the intervention. Based on analysis of the qualitative interviews, the methods of recruitment, the quality of the participant information, the data collection, and the intervention were deemed to be acceptable to the participants (n = 22).ConclusionsThe target of 100 participants was not achieved within the study’s timescale. However, effective strategies were identified that improved recruitment in the final few months. Retention rates and completeness of data in both groups indicate that it is acceptable and feasible to undertake a study promoting sexual health for people with SMI. A fully powered RCT is required to establish effectiveness of the intervention in adoption of safer sex.Study registrationISRCTN RegistryISRCTN15747739 prospectively registered 5th July 2016.

Materialna pamięć krajobrazu cmentarzy w wyludnionych wiejskich jednostkach osadniczych polskiej części dawnych Prus Wschodnich – wybór zagadnień

The article discusses selected issues surrounding cemeteries as important elements of presently abandoned rural settlements located in the part of former East Prussia incorporated into Poland after 1945. It tackles the issue of identification and distribution of burial sites on the researched area and their location in the geographical environment. The discussion is based on a comparative analysis of archival and contemporary cartographic materials and spatial analyses making use of hGIS technology. The results presented in the paper constitute of a part of a study of the impact of the interruption in settlement continuity on landscape in selected localities of the regions of Warmia, Masuria, and Powiśle in the final months of World War II and after the end of the military conflict.

Covid stole my Dad’s final months

OPINION: Because of the pandemic, I couldn’t visit him in his nursing home, and because of his dementia he couldn’t understand why. Mismanagement of this crisis has failed the elderly and caused incalculable hurt.

Nieznane opracowanie: Waldemar Szulc, „Chełmno nad Nerem (Kulmhof). Hitlerowski obóz natychmiastowej zagłady”

Opracowanie Waldemara Szulca to nieznany i dotychczas niepublikowany dokument na temat ośrodka śmierci Kulmhof. Dokument został napisany przez naocznego świadka Waldemara Szulca, który przebywał w najbliższej okolicy ośrodka w ostatnich miesiącach jego funkcjonowania. Opracowanie zostało udostępnione przez syna Waldemara Szulca dopiero w 2020 r.

Take a pay cut and work wherever you want: But should the value of your work depend on where it gets done? - [Spectral Lines

Earlier this year, as the tech workforce moved into the virtual world, Facebook announced that at least some employees could work from home permanently—and choose to relocate. There is a catch to that: Salaries, the company said, would be adjusted to reflect local costs of living. Over the summer, job search firm Hired released a study that reported that only 32 percent of tech professionals around the world would be willing to take such a cut. • Now, in the final months of 2020, as remote workers settle into their commute-less work life, the numbers of those willing to accept a pay cut seems to have grown. Blind, a company that operates private social networks for tech employees, surveyed 5,591 tech professionals and found that 44 percent would be willing to take a pay cut linked to a lower cost of living and 8 percent were indifferent; 48 percent would be opposed to such a cut. • The numbers vary by employer, with tech professionals working at Square, Lyft, Facebook, VMware, and Dropbox the most willing to sacrifice salary for the ability to relocate, and Expedia, PayPal, Microsoft, and Oracle the least. • Comments from those willing to take a cut generally fell into the what's-the-big-deal category. One Facebook employee wrote: “I don't understand all the fuss, are people demanding everyone around the world be paid the same? Let's be real, your pay range is based on your location. People who feel they moved to a place that had 30–50 percent lower range [and] shouldn't be paid like the local employees crack me up.”

Chemotherapy in the Last 30 Days and 14 Days of Life in African Americans With Lung Cancer.

African Americans with lung cancer are diagnosed at later stages and have high mortality rates. Chemotherapy is considered aggressive treatment near the end of life and prevents enrollment in hospice. This study explored chemotherapy in the last 30 and 14 days of life among African Americans with lung cancer. A retrospective chart review was used to gather sociodemographic and treatment data on persons newly diagnosed with lung cancer between January 1, 2016 and June 30, 2017. African Americans with a documented date of death were included. The mean age (N=74) was 64.0 years, 58.1% were rural dwellers, and 59.5% had Medicare. Most had advanced stage non-small cell lung cancer (Stage IIIB, 18.8%; Stage IV, 46.4%). In this study, 17.6% received chemotherapy in the last 14 days of life and 27.0% received chemotherapy in the last 30 days of life. No significant associations between age, sex, residence (rural vs urban) and receipt of chemotherapy in the last 14 or 30 days of life were found. A significant association was found between type of insurance and chemotherapy in the last 14 or 30 days of life: Medicare was associated with chemotherapy in both last 14 days of life χ2(1) = 4.448, p = .035 and last 30 days of life χ2(1) = 4.773, p = .029. A binomial logistic regression using demographic factors, including insurance, was not significant. Our results indicate a need for improvement in the number of individuals who receive chemotherapy in the final month of life.

Prenatal Exposure to Particulate Matter and Placental Gene Expression

Background/Aim: Previous studies of air pollution and placental gene expression were small, candidate gene studies. Further, few considered prenatal windows of exposure and the role of offspring sex. We examined overall and sex-specific associations of prenatal maternal exposure to fine particulate matter (PM2.5) with genome-wide placental gene expression. Methods: Participants with placenta samples and childhood health outcomes from the CANDLE (Memphis, TN) (n=428) and GAPPS (Seattle, WA) (n=114) cohorts of the ECHO PATHWAYS Consortium were included. Exposures to PM2.5 during trimesters 1, 2, 3, and, the first and last months of pregnancy were estimated using a spatiotemporal model. Cohort-specific linear models were fit for each exposure window and individual gene expression (>11,000 coding genes) from paired end RNA sequencing data, adjusted for batch, age, race, offspring sex, season, calendar year of birth, gestational age, mode of delivery, presence/absence of labor, smoking, education, and pre-pregnancy obesity. Models with interaction terms were used to examine sex-specific associations. A false discovery rate (FDR<0.10) was used to correct for multiple testing. Results: Average maternal age and gestational age at delivery were 31-32 years and 38 weeks, respectively. In CANDLE, expression of 41 genes (including SCUBE2, PAEP, PGR, and DKK1) was associated with PM2.5 in the first month of pregnancy while expression of YIPF5 was associated with PM2.5 in the final month of pregnancy. In GAPPS, expression of NBPF9 and IGFBP1 was associated with PM2.5 in the final month of the pregnancy. Offspring sex and third trimester PM2.5 exposure interactions were observed for 29 genes (including ETNK2, CRIM1, and VPS35) in CANDLE and two genes (MARCO and HAPLN3) in GAPPS. Conclusions: We found evidence suggesting association between prenatal PM2.5 exposure, particularly during early and late pregnancy, and placental gene expression (including genes involved in signaling and hormone metabolism). Child sex may modify the association.

“Zero point” The Beginnings of György Ligeti’s Western Career

György Ligeti and his wife fled Hungary in December 1956, travelling through the night of the 11 and 12, and finally reaching Vienna the following day. The existing materials dating from Ligeti’s early emigration demonstrate particularly dynamic correspondence with three Hungarian expatriates: composers Sándor Veress and Mátyás Seiber, as well as the critic John S. Weissmann. 33 letters and postcards and a further 11 replies, held in the Paul Sacher Foundation in Basel, comprise a body of Ligeti’s correspondence with these colleagues dating between the final month of 1956 and the end of 1958. Although evidently incomplete, this unique collection offers novel perspectives surrounding the beginnings of Ligeti’s Western career. Reflecting expectations and future aspirations, these documents trace the excitements as well as challenges of “wiping the slate clean.” Encapsulating Ligeti’s evolving compositional interests and recounting the processes through which he forged new professional relationships, this correspondence reveals insights relating to the composer’s newly- emerging public image. Emigration brought many trials, yet upheaval simultaneously presented an opportunity to radically break with the past. Ligeti could redefine his professional identity as a composer. Although Ligeti felt uneasy in Cologne, it quickly became apparent that engaging in an official capacity with the Electronic Music Studio of the West German Radio (WDR) provided an extraordinary opportunity to establish himself in avant-garde musical circles. Initially shocked by these musical experiments, it was clear to Ligeti that his own creative path lay separate from the avant-garde scene with which he became acquainted in Cologne. Ligeti’s correspondence dating from these encounters indicates that he left Hungary with preconceived musical concepts and aspirations. His experiences with contemporary music rather provided the technical tools through which he could construct and articulate his own concepts, in a manner appearing current in the context of the Cologne-Darmstadt avant-garde.

Climate drivers provide valuable insights into late season prediction of Australian wheat yield

Foresight of grain yields prior to harvest would be empowering for many stakeholders along the supply chain from farmers through to bulk handlers, banks and insurance companies. Estimating Australian grain production ahead of harvest is difficult for many reasons including the highly variable year to year rainfall. The rainfall in the final months prior to harvest, can be crucial to final harvest totals. Here we explore the importance of rainfall from September 1, which broadly corresponds to the close of the top-dressing fertilizer application window, for the remaining cropping season in determining final yield. This is assessed via sensitivity analysis of water-limited wheat potential yield totals from historical climate in the APSIM crop model. At locations where the rainfall influences wheat yield, we compare three methods to forecast wheat yields that differ based on the climate data input: 1) climatology approach, which uses 30 years of observed climate data, 2) analogue climatology, which uses information from climate drivers (El-Niño Southern Oscillation and Indian Ocean Dipole) to create analogue years; and 3) dynamical climate forecasts from a general circulation model (ACCESS-S). We find that potential yields strongly depend on in-season plant available water (PAW) where years with high PAW are unaffected by the late season rainfall. Predicting the potential yield from analogue climatology (climate drivers) had the greatest skill, with smallest Root Mean Squared Error of 0.45 t/ha. This approach ranked first for 42% of the study locations compared to the climatology and ACCESS-S forecasting methods. This knowledge can help inform decision makers about the need to incorporate seasonal climate forecasts and the most appropriate climate forecasting method.

Prenatal exposure to particulate air pollution and gestational age at delivery in Massachusetts neonates 2001-2015: A perspective of causal modeling and health disparities.

Inverse probability weighting (IPW) quantile regression was applied to derive causal marginal population-level GA reduction for GA percentiles associated with increased ambient particulate matter with diameter <2.5 μm (PM2.5) levels at maternal residential address for each trimester and the month preceding delivery using Massachusetts birth registry 2001 to 2015. Stratified analyses were conducted for neonatal sex, maternal age/race/education, and extreme ambient temperature conditions. For neonates at 2.5th, 10th, 25th, 50th, 75th, and 97.5th percentiles of GA at delivery, we estimated an adjusted GA reduction of 4.2 days (95% confidence interval [CI] = 3.4, 5.0), 1.9 days (1.6, 2.1), 1.2 days (1.0, 1.4), 0.82 days (0.72, 0.92), 0.74 days (0.54, 0.94), and 0.54 days (0.15, 0.93) for each 5 μg/m3 increment in third trimester average PM2.5 levels. Final gestational month average exposure yielded a similar effect with greater magnitude. Male neonates and neonates of younger (younger than 35 years) and African American mothers as well as with high/low extreme temperature exposure in third trimester were more affected. Estimates were consistently higher at lower GA percentiles, indicating preterm/early-term births being more affected. Low-exposure analyses yielded similar results, restricting to areas with PM2.5 levels under US ambient annual standard of 12 μg/m3. Prenatal exposure to PM2.5 in late pregnancy reduced GA at delivery among Massachusetts neonates, especially among preterm/early-term births, male neonates, and neonates of younger and African American mothers. Exposure to extremely high/low temperature amplifies the effect of PM2.5 on GA.

Do Graduating Oral-Maxillofacial Surgery Residents Feel Confident in Practicing the Full Scope of the Specialty?

Laskin (2008) suggested that the core of oral and maxillofacial surgery could be divided into 3 levels: 1) areas of expertise, such as oral pathology, oral medicine, dentoalveolar surgery, preprosthetic surgery, and maxillofacial traumatology; 2) areas of competence, including orthognathic surgery, temporomandibular joint surgery, and local reconstructive surgery; and 3) areas of familiarity that include cleft lip and palate surgery, craniofacial surgery, regional reconstructive surgery, oncologic surgery, and cosmetic surgery. The purpose of this study is to assess residents' confidence in practicing the full scope of oral-maxillofacial surgery and their perception of gaps existing in their training. The investigators hypothesized that graduating residents' confidence in practicing the full scope of oral-maxillofacial surgery falls within the suggested levels by Laskin. The investigators implemented a cross-sectional study. A questionnaire was designed, and a link to a Partners REDCap (Nashville, TN) survey was electronically mailed to 252 chief residents in the final month (July 2018) of their program. The questionnaire included resident demographic characteristics, program demographic characteristics, and residents' perceived preparedness, level of proficiency, comfort, and experience for each area. The sample was composed of 78 graduating residents, with a response rate of 31%. Analyses included univariate statistics and a Wilcoxon signed rank test. Significance was set at P<.05. There was no significant difference between orthognathic surgery and each area in the expertise category, and in some cases, a significantly higher perception of ability in orthognathic surgery (P<.05). There was a significantly lower perception of training in oral medicine than each area in the expertise category (P<.05), suggesting a deficit in oral medicine training. Residents perceived that their training in orthognathic surgery was at the level of expertise, higher than expected. They also perceived a training deficit in oral medicine. Training proficiency in dentoalveolar surgery was found to be at a level higher than any other area.

Mortality predispositions of conifers across western USA.

Conifer mortality rates are increasing in western North America, but the physiological mechanisms underlying this trend are not well understood. We examined tree-ring-based radial growth along with stable carbon (C) and oxygen (O) isotope composition (δ13 C and δ18 O, respectively) of dying and surviving conifers at eight old-growth forest sites across a strong moisture gradient in the western USA to retrospectively investigate mortality predispositions. Compared with surviving trees, lower growth of dying trees was detected at least one decade before mortality at seven of the eight sites. Intrinsic water-use efficiency increased over time in both dying and surviving trees, with a weaker increase in dying trees at five of the eight sites. C starvation was a strong correlate of conifer mortality based on a conceptual model incorporating growth, δ13 C, and δ18 O. However, this approach does not capture processes that occur in the final months of survival. Ultimately, C starvation may lead to increased mortality vulnerability, but hydraulic failure or biotic attack may dominate the process during the end stages of mortality in these conifers.

Understanding the Impact Dynamics of Windstorms on Short-Term Economic Activity from Night Lights in Central America

Central America is particularly prone to tropical storms and hurricanes. The prevailing conditions of poverty and socioeconomic inequality in most countries of the region, along with growing urban agglomerations, make their exposed population especially vulnerable to those extreme weather events. This paper quantifies the causal effects of hurricane windstorms on economic growth using night lights in the Central America region at the highest spatial resolution data available (1 km2). The paper uses a unique data set of monthly night light imageries to capture the temporal disaggregation of hurricane impacts on short-term economic activity. Hurricanes in Central America are often localized events and tend to make landfall during the final months of the year that are better captured through monthly –rather than yearly– frequency data. The results suggest that major hurricanes show negative effects up to 12 months after the hurricane strikes (between −2.6 to −3.9% in income growth at the local level). After that, the analysis finds positive effects during the second year and the first half of the third year as evidence of post-disaster recovery (from 2.5 to 3.6% in income growth). The paper contributes to the literature on natural disasters by providing robust estimates of the causal effects of major hurricane windstorms on Central America, which are negative (in the short term) and positive (two years after hurricanes hit).

Dynamic Risk Factors for Handgun Carrying: Are There Developmental or Sex Differences?

ABSTRACT Objective: This study examines the effects of dynamic risk factors on handgun carrying from adolescence into young adulthood. Method: A nationally representative sample of 8,679 individuals (ages 12–26; 51.1% male; 58% White, 26.8% African American; 21.2% Hispanic ethnicity) from the National Longitudinal Survey of Youth (1997 cohort) interviewed at least three times across nine annual waves is used to estimate effects on handgun carrying. Key predictors include gang membership, selling and using drugs, violent crime, and arrest. Using mixed effects models, we focus on within-individual effects across three timeframes from ages 12 to 26: 1) predictors and handgun carrying measured concurrently, 2) predictors measured across one year and handgun carrying measured in the final month of the same year, and 3) predictors measured in the wave before handgun carrying. We also contrast estimates by sex and age. Results: All theoretically relevant predictors statistically significantly predict handgun carrying across the first two timeframes. However, none are statistically significant predictors of handgun carrying in the following year. Few significant sex and age differences emerge. Conclusions: Handgun carrying is an ephemeral behavior particularly during adolescence. The predictors of handgun carrying, which are grounded in gangs, drug use/sale, and crime involvement, appear to have short-term impacts that are consistent across age as well as across sex. Consequently, future work should focus on shorter-term changes in models and there is no evidence that intervention efforts must take fundamentally different approaches to reduce handgun use among males versus females or adolescents versus adults.

Treatment approved for heavy menstrual bleeding associated with fibroids

Oriahnn (AbbVie) is the first and only FDA-approved oral treatment for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. The treatment is a combination capsule containing elagolix 300 mg, estradiol 1 mg, and norethindrone 0.5 mg for the morning dose copackaged with a capsule of elagolix 300 mg for the evening dose. Uterine fibroids, common benign tumors in premenopausal women, can have a significant impact on quality of life, with symptoms such as heavy menstrual bleeding, pain, and bowel and bladder issues. Treatment options have included various surgical procedures such as hysterectomy and myomectomy, and medical therapies to reduce heavy menstrual bleeding (e.g., hormonal contraceptives, tranexamic acid, and NSAIDs). “Although surgical treatments, such as hysterectomy, are available, patients may not qualify for surgery or want the procedure,” said Christine P. Nguyen, MD, acting director, division of Urology, Obstetrics and Gynecology in FDA’s Center for Drug Evaluation and Research in an FDA news release. She noted that “various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use.” The approval of Oriahnn now offers patients a nonsurgical option to help manage their condition. Uterine fibroids can be detected in up to 80% of women by the age of 50. Their growth is dependent on estrogen and progesterone, with the prevalence of fibroids increasing during a woman’s reproductive years. Race has also been identified as a risk factor for uterine fibroids, with Black women having a higher lifetime prevalence of fibroids and more severe symptoms compared with white women. Although some women may be asymptomatic, it is estimated that 20% to 50% of women seek either surgical or nonsurgical treatment to manage their symptoms. Oriahnn contains a gonadotropin-releasing hormone receptor antagonist (elagolix 300 mg), an estrogen (estradiol 1 mg), and a progestin (norethindrone acetate 0.5 mg). The elagolix results in a dose-dependent suppression of luteinizing hormone and follicle-stimulating hormone, leading to decreased concentrations of estradiol and progesterone and reduced bleeding associated with the uterine fibroids. The inclusion of estradiol and norethindrone in the morning dose helps achieve a balance between the reduction of heavy menstrual bleeding and associated hypoestrogenic adverse effects. The labeling states that the estradiol may reduce the bone loss that may occur with the reduction in estrogen levels from the elagolix, and the norethindrone may work to protect the uterus from the potential adverse endometrial effects from unopposed estrogen. The treatment may be given for up to 24 months. Approval was based on data from two randomized Phase III trials that evaluated data from 591 premenopausal women with heavy menstrual bleeding who were treated with elagolix 300 mg, estradiol 1 mg, and norethindrone 0.5 mg in the morning and elagolix 300 mg in the evening or placebo for 6 months. In both trials, more women who received the active treatment had reductions in menstrual blood loss compared with placebo from baseline to the final month of treatment. The most common adverse effects with Oriahnn from the clinical trials were hot flushes, headache, fatigue, and irregular vaginal bleeding. Numerous warnings and precautions are also listed in the label, with bone loss being one of them because of duration-dependent decreases in bone mineral density that may occur due to low estrogen levels. This effect may not be reversible and is the reason for limiting treatment to 24 months. Other warnings and precautions include thromboembolic disorders and vascular events, mood disorders, elevated blood pressure, and changes in menstrual bleeding patterns and the reduced ability to recognize pregnancy. Women should be counseled to use nonhormonal contraception while receiving treatment and for one week after discontinuing the drug.