Impact of the new corona virus (SARS-CoV-2) pandemic on climateric women's health: websurvey

The COVID-19 pandemic has impacted society: causing the collapse of health systems around the world, and also had a significant impact on the economy, personal care, mental health and the quality of life of the population. Few studies have been done about pandemic and the climacteric population, and the impact on quality of life and health. Our objective was to Investigate changes in the health and health care of climacteric women residing in Brazil during the pandemic period. Cross-sectional study with climacteric women aged between 40 and 70 years, residing in Brazil. The evaluation was carried out using a Google Docs electronic form with questions related to sociodemographic, clinical, gynecological data, treatments, access to health services and consultations, as well as changes in behavior. The Menopause Rating Scale - MRS was applied to assess climacteric symptoms, validated for Portuguese. Result(s): 419 women answered the questionnaire. More than 45% were between 51 and 60 years of age, 56.6% being married and residing in Brazilian capitals. 60% of participants reported weight gain during the pandemic. 50.8% of participants reported a decrease in the weekly practice of physical activity More than 80% reported worsening mental health during this period, and 66.1% had a change in their sleep pattern. More than half reported having difficulty accessing gynecological consultations. Women living in capital cities reported a greater increase in alcohol consumption (p=0.002). Food intake increased for 54.9%;the category of civil servant was associated with a significant increase in consumption in relation to other professions (p=0.038). Women whose family incomes changed during the pandemic had a higher prevalence of weight gain (p=0.033) and also had a higher occurrence of changes in sleep quality (72.6% vs. 61.5%;p=0.018). Women with a high school education had a higher occurrence of alterations in personal and health care outcomes (p<0.001). Conclusion(s): We observed an important reduction in the health care of climacteric women during the pandemic period. Changes in life habits, such as increased food consumption and reduced physical activity, were quite prevalent. There was a deterioration in mental health, with a high prevalence of anxiety symptoms and changes in sleep quality. Despite the attenuation of the pandemic, attention should be given to the health care of this population, as the changes may have repercussions for many years.Copyright © 2023

The effect of the COVID-19 pandemic on perimenopausal symptoms

Aim: Menopause is the period of transition from the era of female reproduction to the period of loss of reproductive ability associated with the regression of ovarian functions. Perimenopause period is;It covers premenopausal (2 years before menopause) and menopausal (first 2 years after menopause). The aim of this study was to investigate the effect of the COVID-19 pandemic on menopause symptoms of women who contracted COVID-19 infection during the perimenopausal period when they were more sensitive psychosocially to the pandemic restrictions. Material and method: The study included 103 women aged 45-55 years, who presented at the Gynaecology and Obstetrics Clinic of Turhal State Hospital because of menopause symptoms between June 2021 and August 2021. The women were separated into 2 groups as 32 women who had contracted COVID-19 infection during the previous 6 months and recovered, and 71 women who had not had COVID-19. The groups were compared in respect of age, gravida, parity, body weight, menopause status, and not taking regular exercise using the Menopause Symptom Evaluation Scale. Results: Menopause status (p=0.002), not taking regular exercise (p<0.001), sleep problems (p=0.002), hot flashes (p<0.001), anxiety (p<0.001), and joint-muscle complaints (p=0.002) were determined at statistically significantly higher rates in the COVID-19 group compared to the non-COVID-19 group. Conclusion: The status of not taking regular exercise, thought to be associated with the COVID-19 pandemic restrictions, was observed to increase menopause symptoms. Hot flashes, anxiety and sleep problems in particular were found to be significant complaints in menopausal patients who had been infected with COVID-19. It must be taken into consideration that these could be associated with previous COVID-19 infection. © 2022, Pamukkale University. All rights reserved.

Teaching menopause to health care professionals

The menopause is a stage in the life cycle that affects all women. Managing perimenopausal and postmenopausal health is therefore a key issue for all healthcare professionals, not just gynecologists. The curriculum should include terminology and definitions, assessment, diagnosis and evidence-based management strategies. Healthcare professionals should be aware that women have different perceptions and experiences of the menopause which may be determined by: age and type of menopause, pre-existing health conditions, disability, employment and adverse childhood events. Specialist services may be required for some. These include women with chronic disease, premature ovarian insufficiency or early menopause or pre-existing health conditions and disability, as well as transgender and gender-nonconforming people. The COVID-19 pandemic has changed the mode of delivering healthcare from face-to-face only to include virtual consultations. Teaching now needs to include both types of consultations. A holistic approach is required and teaching should be provided by an accredited expert. Rees M, Abernethy K, Bachmann G, et al. The essential menopause curriculum for healthcare professionals: A European Menopause and Andropause Society (EMAS) position statement. Maturitas. 2022;158:70-77. doi: https://doi.org/10.1016/j.maturitas.2021.12.001Copyright © 2023

Managing the menopause during the pandemic

The structure of the presentation will be 1) Pandemic-Epidemiology 2) General Pandemic-Management 3) HRT and COVID 4) Different spectrum of menopausal symptoms (Europe/Asia) 5) Different risks lead to different HRT. 1) Pandemic-Epidemiology: SARS-COVID-19 has got to be a new disease, China was the first to suffer from the pandemic starting in December 2019 with spread all over the world. Diagnosis, treatment and protective measures have started in Europe in March 2020;up from autumn 2022 in Europe the pandemic changed to endemic, but protective measures still should be continued in risk patients like in hospitals and nursing homes. Rehabilitation will for long-time be an issue like treatment of "Post-" and "Long-COVID". China pursued a zero-COVID-policy until Dec 2022. The sudden stop of almost all measures led to a sharp increase in infections, which shows that the disease will remain a global risk. 2) General Pandemic-Management: Protective measures like vaccination, surgical masks, screening/testing, isolation management, travel/residence history in high-risk regions, education of patients and families had to be the first priority, ahead of other issues such as the management of menopause. 3) HRT and COVID: Already the first prelimary data assessed in Wuhan/China have shown that women with low estradiol-levels had more severe infections with COVID. An analysis of health records of 68,466 COVID-positive patients from 17 countries showed that the fatality risk for women > 50 years receiving HRT was reduced by more than 50% compared to those women not taking HRT (Seeland, 2020). Likewise from a case-control study analyzing the self-reported data of 1.6 million UK menopausal women through the COVID-Symptoms Study Smartphone application (control populations adjusted for age, body mass index, and smoking status) was concluded, that HRT not only can be used, but even can protect from COVID-infections and/or their sequelae (Costeira, 2021). 4) The different spectrum of menopausal symptoms (independent of COVID-infections) comparing data in Europe (showing more vasomotor symptoms) and China (more somatic symptoms) will be presented, including own data. 5) Different risks during HRT consequently lead to different use of HRT, especially more transdermal estrogen combined with progesterone in Europe due to much higher VTE-risk, but more management of the high bleeding-problems in China using individualized (mostly oral) estrogen/progestogen combinations. Copyright © 2023

A Cross- Sectional Assessment of Impact of COVID-19 Vaccine on Menstrual Cycle of Pharmacy and Medical Students of Qassim University, Saudi Arabia

Objectives: To determine the relationship between the COVID-19 vaccine and the menstruation and to determine the factors associated with menstrual abnormalities after COVID-19 Vaccine. Method(s): Female students from the Unaizah College of Pharmacy and Medicine at Qassim University who were over the age of menarche, had received the vaccine, were not pregnant or nursing, were not using contraceptives, did not have a history of primary ovarian insufficiency, hypothalamic menopause, or had undergone a hysterectomy were invited to participate. A universal sampling method was used to collect the data using an online method. Consequently, a total of 299 enrolled students participated in the survey. Result(s): Out of 329 registered students, 299 agreed to participate, giving a response rate of 90.88%. The mean age of the participants was 22.1 +/- 1.70, majority were unmarried (n=255;85.3%) and were from PharmD (n=206;69.8%). A total of 70(26.1%) reported to have COVID-19 infection. About 258(86.2 %) reported menstrual symptoms post-vaccination, of which 108(41.8%) reported irregular, 94(36.4 %)length of menstruation changed, for 56(21.7%) mensuration completely stopped. Only 16(6.20%) required a hospital visit to resolve post COVID vaccination menstrual symptoms. Previous COVID 19 infection significantly influenced the incidence of mensural abnormalities (p=0.03). After the second dose of the vaccine, Pfizer-BioNTech (91.3%) followed by Johnson and Johnson (66.7%), there were significant variations in the menstrual abnormalities across different vaccination types (p = 0.014). Conclusion(s): The study showed a possible link between the COVID-19 vaccine and menstrual abnormalities which needs further investigation regarding its impact on their quality of life.Copyright © 2023

Impacts of pregnancy and menopause on COVID-19 severity: A systematic review and meta-analysis of 4.6 million women.

BACKGROUND: COVID-19 pandemic is still a public health emergency of international concern. However, whether pregnancy and menopause impact the severity of COVID-19 remain unclear. AIM: This study is performed to investigate the truth. DESIGN: Study appraisal and Synthesis follows PRISMA guideline. Meta-analysis is performed in random-effects model. METHODS: PubMed, Embase, Cochrane database, Central, CINAHL, ClinicalTrials.gov, WHO COVID-19 database, and WHO-ICTRP are searched until March 28 2023. RESULTS: In total, 57 studies (4,640,275 COVID-19 women) were analyzed. Pregnant women were at a lower risk of severe COVID-19, intensive care unit (ICU) admission and disease mortality compared to those nonpregnant women with comparable comorbidities. In contrast, pregnant women with more prepregnancy comorbidities were at a higher risk of severe COVID-19, ICU admission and invasive mechanical ventilation (IMV). In addition, pregnant women with pregnancy complications had a significantly increased risk of severe COVID-19 and ICU admission. Menopause increased COVID-19 severity, IMV requirement and disease mortality. Hormone replacement therapy (HRT) inhibited COVID-19 severity in postmenopausal women. Premenopausal and postmenopausal women had a lower chance of severe illness than age-matched men. The impact of pregnancy on COVID-19 severity was significant in Americans and Caucasians, while the effect of menopause on COVID-19 severity was only significant in Chinese. CONCLUSIONS: Pregnancy and menopause are protective and risk factors for severe COVID-19, respectively. The protective role of pregnancy on COVID-19 is minimal and could be counteracted or masked by prepregnancy or pregnancy comorbidities. The administration of estrogen and progesterone may prevent severe COVID-19.

Is Treating Post-Menopausal Women With Symptomatic Hand Osteoarthritis With Hormone Replacement Therapy Feasible?: Results From The Hope-E Randomised, Placebo-Controlled Feasibility Study

Purpose: Hand osteoarthritis (OA) is more common in women. Hand OA incidence increases further in females around the age of 50, the typical age of menopause. Estrogen-deficient states are associated with increased musculoskeletal pain and inflammation and with increased rates of symptomatic OA. Estrogen replacement and selective estrogen receptor modulators (SERMs) can improve pain and structure in some pre-clinical models of OA associated with estrogen loss, and in exploratory analysis from hormone replacement therapy (HRT) trials. However, no randomised clinical trials (RCTs) of HRT had been performed in symptomatic OA populations, specifically hand OA. By carrying out a RCT feasibility study of a form of HRT (conjugated estrogens (CE)-bazedoxifene) in post-menopausal women with painful hand OA, we set out to determine the feasibility and acceptability of this. We also aimed to generate proof-of concept data on likely outcomes, calculate a sample size and refine methods for a full trial. Method(s): We recruited females aged 40-65 years and 1-10 years after final menstrual period with definite hand OA and >=2 painful hand joints across three primary/secondary care sites and from the community. Medical exclusions included those typical for clinical HRT use. Design was parallel group, double-blind 1:1 randomisation of CE-bazedoxifene or placebo, taken orally once daily for 24 weeks, then tapering for 4 weeks before study end at Week 28. Primary feasibility outcomes were rates of eligible participant identification, recruitment, randomisation, retention, compliance, and likelihood of unblinding. Adverse events (AEs) were collected. Secondary clinical outcomes included the anticipated primary outcome in a full trial of mean hand pain over 14 days prior to each visit, scored on a 0-10 numerical rating scale (NRS) where 10 is worst pain possible, as well as hand function, appearance and menopause symptoms. Progression criteria to a full RCT were: (i) recruitment >=30 participants across all sites in 18 months (or proportionate to time open);(ii) a drop-out rate of <=30% of randomised individuals;and (iii) acceptability to the majority of participants, including acceptable AE rates. All clinical outcomes were analysed on an intention-to-treat basis. Though not powered to detect a treatment difference, change and treatment effects (the difference in the outcome between the two groups) were indicated with 95% CIs, with all models adjusted for clinical subtype of painful hand joint, study site, and baseline values. The sample size for a full trial was estimated using the standard deviation (SD) of week 24 mean hand pain. Result(s): Due to the COVID-19 pandemic, the recruitment window was reduced to 12-15 months. From May 2019 to December 2020, 434 enquiries/referrals were received. Of 96 telephone pre-screens, 35 individuals were potentially eligible and of these, 33 gave consent to participate. Of the remaining, 250/401 (62%) were ineligible, whilst 55/401 (14%) chose not to proceed, with the most common reason being not wanting to take HRT. 28/35 (80% (95%CI 63%,92%)) eligible participants were randomised to study medication. All 28 participants completed all follow-ups with high compliance (100% active, 13/14[93%] placebo) and outcome measure completeness (100%, mean hand pain). All three AE-related treatment withdrawals were on placebo when unblinded. No serious AEs occurred. Participants/investigators were well blinded (participant blinding index 0.50[95%CI 0.25 to 0.75]). All three prespecified progression criteria were therefore met for a full trial. The treatment effect difference over 24 weeks in mean hand pain between active and placebo was -0.71 (95% CI -2.20 to 0.78) (Fig 1A). During tapering/stopping medication, mean hand pain increased by 1.31 points in the active arm compared with 0.17 in the placebo arm, indicating a possible effect of cessation of medication (Fig 1A). Furthermore, 6/13 (46%) participants in the active group reported worsening pain at week 28 compared with week 24, but only 2/12 (17%) were worse on withdrawing placebo (Fig 1B). The sample size for a full trial was estimated as 296 (based on MCID 0.8 on NRS, SD 2.0, 90% power, 10% drop-out, alpha 5%). Conclusion(s): This first study of a RCT of HRT for painful hand OA met its progression criteria, indicating that a full trial of an HRT in this population is feasible and acceptable. Although not powered to detect an effect, there was a trend towards improvement in hand pain on treatment and worsening of hand pain on tapering in the active arm only. This adds to proof-of-concept data in this area, justifying more work.ISRCTN12196200. Funded by Research for Patient Benefit programme, National Institute for Health Research (UK) PB-PG-0416-20023 [Formula presented]Copyright © 2023

In brief

Research shows that while inhaling gas and air (Entonox) in labour is safe for mothers and babies, long-term cumulative exposure may carry health risks. Work notice The right to strike The UK government's Strikes (Minimum Service Levels) Bill is, at the time of going to press, at the committee stage in the House of Lords (the first chance for line-by-line examination). Visit bit.ly/ Clementine-register Working mums Maternity leave Careers After Babies research has found that of 848 mothers interviewed, 98% want to return to work after having a child but just 13% can make it work full-time, citing the cost of childcare and lack of flexibility from businesses as the reason. Find out more at hegenbergermedical.com/training Research Healthy eating support Researchers at the University of Hertfordshire are calling for better information on diet and nutrition to be made available to expectant parents.

COVID-19 Impact on Women's Health

Introduction The COVID-19 pandemic and associated social distancing and/or lockdowns have impacted social and personal interactions. Objective To assess COVID's impact on partner relationships, sexual activity, family planning, and menopause management. Methods C Space online communities were surveyed from April 14 to 28, 2021. C Space is an online community platform;each community is unique to the client for which it is designed. For this study, three communities were surveyed: a 100-member community of healthcare professionals (HCPs) who treat women's health issues, a 300-member community of reproductive-age women, and a 300-member community of women in their menopausal years. Of the 100 HCPs, 78 responded (25% OB/GYNs, 49% primary care providers, and 26% nurse practitioners or physician assistants);of the 300 reproductive age women, 184 responded;of the 300 women in their menopausal years, 215 responded. Results Fifty-four percent of reproductive-age women reported that their relationships with their partners have improved during the pandemic, while nearly a third (31%) reported their relationships have suffered. Conversely, just over a third (38%) of menopausal women claim their relationships with their partners improved, while 45% reported that their relationships have suffered. Among women with sexual partners (n=158 reproductive-age women;n=168 menopausal women), 46% of reproductive-age women and 62% of menopausal women reported having sex with the same frequency as before the pandemic. Of the reproductive-age women, 27% reported having sex with more frequency and 22% with less frequency. Among menopausal women, 10% reported having more sex, and 17% reported having less frequent sex than before the pandemic. Nearly half (46%) of those who were considering or actively trying to get pregnant pre-COVID responded they were less likely to try to conceive now, with 36% saying they have not changed, and 18% responded they are more likely to try to conceive.For birth control, the majority (72%) of HCPs reported no change in prescribing, with 14% citing an increase and 14% citing a decline. Of the 75% of reproductive-age women who were taking birth control (n=138), the majority (70%) reported no change in their use of birth control, 22% reported making a change or starting a new treatment, and 11% (n=15) responded that they stopped taking birth control during the pandemic.For menopause management, the majority of HCPs (62%) reported no change in the use of hormone therapy, and nearly a third (31%) reported a decline in use. Of the 20% of menopausal women (n=42) who were on a menopause hormone therapy, over half (52%) responded that they made no change to their treatment, nearly a third (31%) made a change or started a new therapy;17% (n=7) stopped treatment during the pandemic. Conclusions The COVID pandemic has impacted women differently depending on their reproductive or menopause status including their relationships with their partners, sexual activity, family planning and use of birth control or hormone therapy.

Changes in preferences for ovarian cancer prevention strategies during the COVID-19 pandemic: Results of a discrete choice experiment

Background: The COVID-19 pandemic influenced patient health care decisions, but there is little information about the pandemic's impact on decisions about cancer risk reduction. This includes women at elevated risk of breast or ovarian cancer considering risk-reducing salpingooophorectomy (RRSO), risk-reducing salpingectomy (RRS), or other preventive measures. During the pandemic patients needed to balance their concerns about cancer risk reduction with their risks associated with elective health procedures, a risk which changed as vaccines became available. Method(s): To address the impact of the COVID-19 pandemic on cancer prevention decision making, we recruited N=396 pre-menopausal women with a personal history of breast cancer or familial history suggestive of increased breast and/or ovarian cancer risk between 4/2019 and 3/2022. We conducted a discrete choice experiment in which patients were asked to choose between two scenarios that specified type of surgery (RRSO, RRS vs. non-surgical surveillance), age of menopause (natural versus immediate), quality of menopausal symptoms (mild, moderate, severe), and risk of ovarian cancer, heart disease, or osteoporosis. Risk of ovarian cancer for the scenarios provided varied in discrete intervals from 0% to 40%. We examined temporal trends during the pandemic using interactions with time coinciding approximately with the beginning of pandemic, peak vaccination period, and the Omicron wave. Result(s): We identified significant temporal interactions on a woman's prevention decisions. In 2019, women at higher risk of ovarian cancer were more likely to choose prevention scenarios that favored lower ovarian cancer risk (odds ratio [OR] = 0.48;95% CI = 0.37, 0.69 per 10% increase in ovarian cancer risk difference). This association decreased through the pre-vaccine period of 2020 by OR=2.61/month (95% CI = 1.21, 5.65). By June 2020, the effect of a 10% increase in ovarian cancer risk on intervention choice had attenuated substantially (OR=0.84, 95% CI 0.67, 1.00). By January 2022, the effect strengthened (OR= 0.69, 95% CI .49, .88), but had not reached pre-pandemic levels. Before 3/2020, natural age of menopause (versus immediate) had a strong impact on the choice of a scenario (OR=3.56, 95% CI 1.65-7.65). At the beginning of the pandemic, the effect was reduced by 0.47/month (95% CI 0.22-0.99). The rate of attenuation slowed over time, such that the effect of having a natural age of menopause on choice was OR= 1.56 (95% CI 0.65, 2.46) by January 2022. Tests for temporal interactions were statistically significant for both ovarian cancer risk and age of menopause. Conclusion(s): Our results suggest that over the course of the pandemic, women seemed more accepting of higher risks of ovarian cancer and immediate (post treatment) menopause when considering preventive options. There was an inverse U shape curve of the effect of ovarian cancer risk on choices over time (Figure A), but the strength of the relationship had not reached prepandemic levels by January 2022. This may reflect patient tolerance for side effects as the pandemic evolved. These results suggest that factors such as ovarian cancer risk and delay of menopause influenced personal prevention choices, but that these choices were influenced by events related to events that hallmarked the COVID-19 pandemic.

An outpatient service evaluation in a UK tertiary referral centre for paediatric and adolescent gynaecology

Background: Pressure on waiting lists prompted this service evaluation in a tertiary referral centre for paediatric and adolescent gynaecology (PAG). The service is located in Bristol in England. The centre is one of 11 commissioned by NHS England to provide care for patients with congenital gynaecological anomalies, as well as seeing patients with other PAG presentations from aged 2 upwards. Alongside general PAG clinics, there is a quarterly multi-disciplinary transition clinic for children with differences in sex development and a monthly joint adult endocrinology / gynaecology clinic where patients with Turner Syndrome are seen annually. Aim(s): To collect and analyse data pertaining to the pre-Covid PAG outpatient service, to inform1 anticipated service developments aimed at reducing waiting list times for new patients and streamlining of services for certain patient groups Methods: This service evaluation was registered with the local clinical audit team (GYNAE/SE/2020-21-11). We performed a retrospective review of the electronic notes of every PAG appointment from 1st March 2019 - 29th February 2020 (pre-Covid-19 UK restrictions). A database of PAG clinics was created and then the team manually went through each appointment's notes / letters and extracted the relevant data which was entered into a Microsoft Excel spreadsheet. Result(s): There were 385 appointments during this time period. There was data available for 376 appointments and 338 of these were filled by PAG patients. 72 appointments were (21%) for primary ovarian insufficiency (POI) of late effects of childhood cancer, 53 (16%) were for patients with Turner syndrome and 48 (14%) for heavy menstrual bleeding, of which 23 (48%) were new referrals, with this being the most common reason for referral to the team. The remaining appointments were for a variety of conditions. Conclusions and Actions: Our services would benefit from streamlining to maximise capacity and reduce waiting times. To this end: - A second endocrinologist has been recruited to double capacity for the Turner Syndrome clinic2. - An adolescent heavy menstrual bleeding clinic3,4 has been set up to streamline care for these patients. This is a one-stop face-to-face clinic offering a transabdominal pelvic ultrasound scan and a telephone follow-up 3 or 6 months later - To consider a POI / late effects of childhood cancer service to run alongside the menopause and reproductive medicine clinics with psychology support5 PAG constitutes a wide range of diagnoses, and a regular assessment is helpful to ensure care can be offered as efficiently as possible.Copyright © 2023

OPTIMA, a prospective randomized trial to validate the clinical utility and cost-effectiveness of gene expression test-directed chemotherapy decisions in high clinical risk early breast cancer

Background: Multi-parameter tumor gene expression assays (MPAs) are used to estimate individual patient risk and guide chemotherapy use in hormone-sensitive, HER2-negative early breast cancer. The TAILORx trial supports MPA use in a node-negative population. Evidence for MPA use in postmenopausal node-positive breast cancer has been provided by the RxPONDER trial interim analysis but this relies on the absence of superiority in an analysis where >50% of events were unrelated to breast cancer. There is much uncertainty about MPA use for premenopausal patients. OPTIMA (Optimal Personalised Treatment of early breast cancer usIng Multi-parameter Analysis) (ISRCTN42400492) is a prospective international randomized controlled trial designed to validate MPAs as predictors of chemotherapy sensitivity in a largely node-positive breast cancer population. Method(s): OPTIMA is a partially blinded study with an adaptive two-stage design. The trial recruits women and men age 40 or older with resected ER-positive, HER2-negative invasive breast cancer and up to 9 involved axillary lymph nodes. Randomization is to standard management (chemotherapy and endocrine therapy) or to MPA-directed treatment using the Prosigna (PAM50) test. Those with a Prosigna tumor Score (ROR-PT) >60 receive standard management whilst those with a low score (<=60) tumor are treated with endocrine therapy alone. Endocrine therapy for premenopausal women includes ovarian suppression for all participants unless they experience a chemotherapy-induced menopause. Adjuvant abemaciclib is permitted. The trial will be analyzed for (1) non-inferiority of recurrence according to randomization and (2) cost-effectiveness. The key secondary outcome is non-inferiority of recurrence for patients with low ROR-PT score tumors. The efficacy analyses will be performed Per Protocol using Invasive Breast Cancer Free Survival (IBCFS) as the primary outcome measure to limit the risk of a false non-inferiority conclusion. Recruitment of 4500 patients over 8 years will permit demonstration of up to 3% non-inferiority of test-directed treatment with at least 83% power, assuming 5-year IBCFS is 87% with standard management. An integrated qualitative recruitment study addresses challenges to consent and recruitment, building on experience from the feasibility study which found that a multidisciplinary approach is important for recruitment success. OPTIMA is strongly supported by a patient group which has helped design all patient documents and which is represented on the TMG. Result(s): The OPTIMA main trial opened in January 2017 and has continued to recruit throughout the COVID-19 pandemic. Overall recruitment as of 1 July 2022 was 2814 (2593 from UK, 221 from Norway). Patient characteristics are well balanced between the trial arms. Currently 95% of randomized participants are eligible for inclusion in the PP analysis. 66% of the MPA-directed arm participants have been allocated to endocrine therapy only. The test failure rate is < 1%. Conclusion(s): OPTIMA will provide robust unbiased evidence on test-directed chemotherapy safety for both postmenopausal and premenopausal women with 1-3 involved nodes as well as for patients with 4-9 involved nodes and for patients treated with abemaciclib.

How Perimenopause Shaped Perspectives on Life during the Pandemic: A Study on India's Working and Non-Working Women

The menopausal transition is a challenging phase in a woman's life and has been compounded by the COVID-19 pandemic. This study aimed to examine the association between meaning in life, quality of life, and satisfaction with life among perimenopausal women during the pandemic, as well as to determine if there was a difference in attitudes towards life between working and non-working perimenopausal women. The study sample consisted of 114 perimenopausal women, with 64 being employed and 50 being non-employed. A quantitative cross-sectional design was employed, and the results showed that satisfaction with life was positively correlated with both meaning in life and quality of life. Working perimenopausal women had a higher level of satisfaction with life (mean score of 63.24) as compared to non-working perimenopausal women (mean score of 50.14), but there was no significant difference in quality of life or meaning in life between the two groups. The study highlights the impact of various social and personal factors on how women perceive their lives during the pandemic and underscores the need for increased support and resources for perimenopausal women in the workplace. Additionally, promoting menopause awareness in general and in the workplace could help to reduce social barriers and improve women's perspectives on life, leading to an improvement in their overall quality of life and satisfaction with life. This study insisted on the need for giving importance to this stage in women's life-rather passing it just like that. Policy makers in the HR field should make a note to the finding and incorporate necessary amendment in terms of the female workforce.

Bring the life stages into the domain of basic and clinical pharmacology.

Completely distinct physiological conditions and immune responses exist among different human life stages. Age is not always consistent with the life stage. We proposed to incorporate the concept of the life stages into basic and clinical pharmacology, including clinical trials, drug labels, and drug usage in clinical practice. Life-stage-based medical treatment is the application of medicine according to life stages such as prepuberty, reproductive, and aging. A large number of diseases are life-stage-dependent. Many medications and therapy have shown various age effects but not been recognized as life-stage-dependent. The same dosage and drug applications used in different life stages lead to divergent outcomes. Incorporating life stages in medicine and drug usage will enhance the efficacy and precision of the medication in disease treatment.

Presidential reflections: how we got here, where we might go.

Pieter van Keep was a founder and the third president of the International Menopause Society (IMS). He died, sadly, in 1991. Since then, every retiring president of the IMS has delivered the Pieter van Keep Memorial Lecture. This is an edited version of that lecture delivered at the 18th World Congress of the IMS in Lisbon, Portugal in 2022. In the article, President Steven R. Goldstein describes the path he followed that led him to the presidency of the IMS, including his original entry into transvaginal ultrasound, then gynecologic ultrasound and, ultimately, menopausal ultrasound. His was the first description of the benign nature of simple ovarian cysts, the ability of transvaginal ultrasound to exclude significant tissue in patients with postmenopausal bleeding and the significance of endometrial fluid collections in postmenopausal patients, just to name a few. However, it was his description of the unusual ultrasound appearance in the uterus of women receiving tamoxifen therapy that allowed his entry into the world of menopause. This, ultimately, led to leadership positions, and ultimately the presidency of the American Institute of Ultrasound in Medicine, the North American Menopause Society and, finally, the IMS, all chronicled in this article. In addition, the article describes in detail the activities of the IMS during the COVID pandemic.

The impact of COVID-19 on a specialised menopause clinic: Changes in practice and women's experiences.

AIMS: The COVID-19 pandemic necessitated the rapid change in a dedicated multidisciplinary menopause clinic from in-person consultations to telehealth. The aim of this study was to explore the impact of COVID-19 on menopause service delivery and consumer experiences. METHODS: Two-part study involving the following. (i) Clinical audit conducted June-July 2019 (pre-COVID-19) and June-July 2020 (COVID-19) assessing practice and service delivery changes. Assessment outcomes included: patient demographics, cause of menopause, presence of menopause symptoms, appointment attendance, medical history, investigations and menopause treatments. (ii) A post-clinic online survey exploring the acceptability and experience of telehealth, once telehealth models of care had been routinely used in the menopause service (2021). RESULTS: Pre-COVID (n = 156) and COVID-19 (n = 150) clinic consultations were audited. Menopause care delivery changed significantly from 100% face-to-face consultations in 2019 to 95.4% telehealth consultations in 2020. In 2020, fewer women had investigations performed vs 2019 (P < 0.001), although use of menopausal therapies was similar (P < 0.05). Ninety-four women completed the online survey. Most women (70%) were satisfied with their telehealth consultation and perceived that the doctor effectively communicated with them (76%). Women preferred face-to-face consultations for their first menopause clinic visit (69%) and telehealth for review consultations (65%). The majority of women (62%) viewed the continuation of telehealth consultations as 'moderately' to 'extremely useful' post-pandemic. CONCLUSION: The COVID-19 pandemic caused significant changes to menopause service delivery. Telehealth was perceived as feasible and acceptable by women, supporting the continuation of a hybrid service delivery model incorporating telehealth and face-to-face consultation to meet the needs of women.

A Review of Stellate Ganglion Block as an Adjunctive Treatment Modality.

Peripheral nerve blocks are becoming increasingly used as adjunctive treatment modalities for a variety of conditions refractory to medical management. Right or left stellate ganglion blocks (SGB) are a specific type of peripheral nerve block that target the sympathetic blockade of neuronal impulses using the injection of local anesthetic and steroids into nerve bundles in the cervical area. This review article is intended to summarize the common uses of stellate ganglion blocks and explain the procedural technique, which has evolved with technological advances in ultrasonography. The similarities between these disease processes are centered around sympathetic hyperactivity. This sympathetic overdrive state is created by increased levels of nerve growth factor (NGF), which causes a cascade of sympathetic sprouting resulting in increased norepinephrine (NE) systemically. Reversal of this cascade by local anesthetic injection into the stellate ganglion thereby reduces NGF and sympathetic sprouting subsequently lowering overall norepinephrine levels. This is the unifying theory by which SGB is able to provide resolution for the varied clinical conditions described in this article.  This review article discusses the physiology of several conditions where stellate ganglion blocks are being investigated as an adjunct treatment modality, including anosmia, PTSD, long-COVID, chronic fatigue syndrome, menopausal hot flashes, and ventricular tachyarrhythmias. Overall, the current literature supporting the use of stellate ganglion blocks for several esoteric conditions is limited; however, case reports to date have shown promising evidence-based results supporting their use as an adjunctive treatment among patients with refractory symptoms to existing treatment algorithms. In conclusion, SGB should be considered among patients with refractory symptoms for medical management in the conditions discussed in this article. Further research is needed to delineate which patients will benefit from the use of SGB, the use of subsequent blocks and timelines in between injections, and unilateral versus bilateral blockade.

The relationship between sex steroids (E2, progesterone, and AMH) levels and severity and fatality of COVID-19: A systematic review.

Sex steroids are powerful modulators of the immune system and they may affect the immune response and inflammatory consequences of COVID-19. This systematic review aims to explore the impact of sex steroids on COVID-19 mortality and complications. We looked up the keywords of the study in Scopus, PubMed, and Web of Science. All related original articles published in English, as of October 16, 2021, were reviewed to be included in our research. Concerns regarding the effect of sex hormones on COVID-19, eight full texts have been identified for the conclusion. In these studies, the relationship between estradiol and COVID-19 mortality has been mentioned. The most significant findings were the higher COVID-19 mortality rate in men, compared to women; also, in menopausal women compared to younger women and who received estradiol. In two studies, oral contraceptive pills had a protective effect on the morbidity of SARS-CoV-2 infection. In a randomized controlled trial, subcutaneous injection of progesterone in hospitalized men significantly reduced their symptoms and need for oxygen therapy. Hormone replacement therapy was positively associated with reducing COVID-19 symptoms. Although the results were insufficient for a conclusion, this study represents estrogen as an appropriate pharmacological method for preventing and diminishing the inflammation related to COVID-19 disease. However, future prospective studies and clinical trials are needed to clarify and approve this protective effect.