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Objective: The aim of the study is to identify suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects., Methods: A systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome., Results: A total of 21,207 publications were screened from which 119 reporting on 40 PROMs were identified. Of these 40 PROMs, 36 either did not adequately map onto the core outcomes or lacked sufficient measurement properties. Therefore, only four PROMs corresponding to two of the six core outcomes were considered for recommendation. We recommend the Hot Flash Related Daily Interference Scale to measure the domain of distress, bother, or interference of vasomotor symptoms and to capture impact on sleep (one item in the Hot Flash Related Daily Interference Scale captures interference with sleep). Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events, which is a requirement of Good Clinical Practice., Conclusions: We identified suitable definitions and PROMs for only three of the six core outcomes. No suitable PROMs were found for the remaining three outcomes (frequency and severity of vasomotor symptoms and satisfaction with treatment). Future studies should develop and validate PROMs for these outcomes., Competing Interests: Financial disclosure/conflicts of interest: V.P. received past funding from Sigvaris AG. M.P. received institutional funding from University of Melbourne (Internal Grant Schemes), Royal Women's Hospital (Internal grant scheme), and Cancer Council NSW Project Grant RG 21-06, Centre for Research Excellence in Women's Health in Reproductive Life (CREWHiRL) Seed Funding and Project Support Grant, NHMRC (APP1163202), and Royal Children's Hospital Foundation. She received past funding from FertilityIQ webinar honorarium. She has received fee registration fees as an invited speaker by the Pacific Society of Reproductive Medicine 2023 Conference and had subsidized flights and accommodations as an invited speaker for the European Society of Human Reproduction and Embryology 2022 Conference. She was also given free registration as an invited speaker for the Annual Scientific Meeting of Breast Cancer Trials 2021. D.A. has consulted for Evestra, Exeltis, Lupin, Mithra, ObsEva, and TherapeuticsMD, received industry support for research from AbbVie, Mithra, Myovant, and ObsEva, and has stock holdings in Agile Therapeutics, InnovaGyn, Inc. N.A. receives ongoing institutional funding from the National Cancer Institute. J.C. is owner of JSCarpenter, LLC which received scale licensing fees from Mapi Research Trust (2022), consulting fees from the University of Wisconsin (spring 2022), and consulting fees from Simumetrix SMX Health (spring 2022). M.C. has been paid for developing and delivering educational presentations for Alliance Chicago, received fees for an educational video and speaking engagements with Fertility IQ, wrote a White Paper on GSM for Materna (no financial reimbursement), and is a member of The Menopause Society Board of Trustees. M.D. receives current institutional funding from National Institute of Health Research. She serves as a chief investigator on POISE study (research relevant to HRT) and a chief investigator for BLUSH study (research on treatment of menopause). She received past institutional funding from Best Practice & Research Clinical Obstetrics & Gynaecology as editor of volume on menopause management published 2022. She is an elected member of the Medical Advisory Council of the British Menopause Society, is a member of the ESHRE guideline update group on Premature Ovarian Insufficiency, is a member of the British Endocrine Society working group producing clinical guidelines on estrogen treatment, and is a member of the British Gynaecological Cancer Society working group producing clinical guidelines on HRT. T.H. received past funding from Besins and Astellas. M.H. receives ongoing funding from Rightsteps and current funding from Hello Therapeutics. L.K. has lectured and/or acted in an advisory capacity for Gedeon Richter, Dr. KADE Besins and Mithra. P.M. has received compensation as a member of the scientific advisory board of Astellas, Bayer, and Johnson & Johnson; compensation from AbbVie and Pfizer for consulting; and serves as a member of the scientific advisory board and has/had equity in Alloy, Estrigenix, and MidiHealth. She has received speaking fees and travel support from Mithra. R.E.N. has ongoing relationships with Abbott, Astellas, Bayer HealthCare AG, Besins Healthcare, Exeltis, Fidia, Gedeon Richter, HRA Pharma, Merck Healthcare, Novo Nordisk, Shionogi Limited, Theramex, and Viatris. N.P. has lectured and/or acted in an advisory capacity for Abbott, Lawley, Mithra, Novo, SeCur, and Viatris. S.R. has lectured and/or acted in an advisory capacity or conducted studies for Abbott, Bayer, Gedeon Richter, Mylan, Amgen, UCB, Theramex, and Viatris. J.S. receives grant/research support from AbbVie, Inc., Bayer Healthcare LLC., Dare´ Bioscience; Ipsen, Mylan/Viatris Inc., Myovant Sciences, Sebela Pharmaceuticals Inc. He acts as a consultant is on advisory boards for Bayer HealthCare Pharmaceuticals Inc., Besins Healthcare, California Institute of Integral Studies (CIIS), Dare´ Bioscience, Femasys Inc., Khyria, Madorra Pty Ltd., Mayne Pharma, Inc., and Vella Bioscience Inc. He serves on speaker's bureaus for Astellas Pharma, Inc., Mayne Pharma, Inc., Myovant Sciences, Inc., Pfizer Inc., Pharmavite LLC., Scynexis Inc. He is a stockholder (direct purchase) of Sermonix Pharmaceuticals. P.S. has received fees for giving educational presentations, participating in advisory boards and conducting research by Besins Healthcare, Astellas, Mylan, Labatec, Exeltis, Effik, Theramex, and Gedeon-Richter. A.J.V. has received fees for presentations and participation in an advisory board from Besins and Theramex. W.W. has received institutional support with an unrestricted grant from Pfizer and sits on the advisory boards of Pfizer, Lupin, and Biosyent. She has received fees for educational presentations for Lupin, Astellas, Bayer and Pfizer, and Biosyent. She is a board member of the International Menopause Society and the President of the Canadian Menopause Society. M.H. has received funding from Madorra for a study of a device to manage GU symptoms and is a clinical expert for the NICE Menopause Guidelines. J.T.G. is a speaker for NurtureMed Pharma, Bayer Phils, Corbridge Phils, and Zuellig Pharma. P.S. has a research consultancy relationship with Chugai Pharmaceuticals. H.J. receives grant funding from the National Institutes of Health, Merck, and Pfizer and is a consultant to Bayer, Merck, and Hello Therapeutics. She receives in kind support from Sage to her institution (drug provided to support NIH-funded trial), funds from Bayer support a pilot grant program she lead within an NIH-funded Center grant. Her spouse is employed by Arsenal Biosciences and receives equity from Merck Research Labs. N.J. is on the advisory board of Vira Health, UK. All other authors report no conflicts of interest., (Copyright © 2024 by The North American Menopause Society.)

Background: Emerging evidence suggests that perceived gender discrimination negatively impacts mental wellbeing in young women., Purpose: This study explored whether a similar relationship exists in middle-aged and older women., Methods: A total of 3081 women (aged ≥52 years) from the English Longitudinal Study of Ageing provided data on perceived gender discrimination in 2010/11. Depressive symptoms, loneliness, quality of life and life satisfaction were assessed in 2010/11 and in 2016/17., Results: Perceived gender discrimination was reported by 282 (9.2%) participants. Cross-sectionally, women who perceived gender discrimination reported more depressive symptoms (β = 0.34, 95% CI 0.11 to 0.57) and had higher loneliness scores (β = 0.14, 95% CI 0.08 to 0.20) than women who did not perceive gender discrimination. They also reported significantly lower quality of life (β = -2.50, 95% CI -3.49 to -1.51) and life satisfaction (β = -1.07, 95% CI -1.81 to -0.33). Prospectively, perceived gender discrimination was associated with greater loneliness scores (β = 0.08, 95% CI 0.02 to 0.14), as well as lower ratings of quality of life (β = -0.98, 95% CI -0.09 to -1.86), and life satisfaction (β = -1.04, 95% CI -0.34 to -1.74), independent of baseline values., Conclusions: Middle-aged and older women who perceive gender discrimination report poorer mental wellbeing than those who do not perceive discrimination. Further, this type of discrimination may be predictive of declining mental wellbeing over time. These findings highlight the need for interventions to target gender-based discrimination to improve the wellbeing of women at mid- and older age., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Hackett et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Menopause eventually happens to all people with typically functioning ovaries, and almost one billion women worldwide are postmenopausal. Although the biology of typical menopause is ubiquitous, the experience varies substantially. Factors contributing to the experience include not only individual factors, such as the nature and severity of symptoms, but also psychological, social, and contextual considerations, many of which are modifiable. In this first paper in the Lancet Series on menopause, we argue for a new approach that goes beyond the treatment of specific symptoms, to encompass a broad model to support women transitioning this life stage, using the model of empowerment. WHO defines empowerment as an active process of gaining knowledge, confidence, and self-determination to self-manage health and make informed decisions about care. Rather than focusing on menopause as an endocrine deficiency, we propose an empowerment model that recognises factors modifying the experience, in which the patient is an expert in their own condition and the health-care worker supports the patient to become an equal and active partner in managing their own care., Competing Interests: Declaration of interests MH declares salary funding from the Australian National Health and Medical Research Council, support for meeting attendance from the UK National Institute for Health and Care Excellence, and the following roles: principal investigator for a clinical trial of salpingectomy vs salpingo-oophorectomy for prevention of ovarian cancer (TUBA-WISP II); board member for Breastscreen Victoria; editor for the Cochrane Collaboration; recipient of a fellowship from the Lundbeck Foundation (2022-23); site investigator for a clinical trial of a non-hormonal agent (Q-122) for vasomotor symptoms in patients with breast cancer (QUE Oncology, 2020-22); and site investigator for a clinical trial of a medical device for treating vaginal dryness (Madorra). AZL has grant funding for research on menopause from the National Institute on Aging of the National Institutes of Health in the USA. MSH has worked in collaboration with Rightsteps UK to develop CBT solutions for menopausal symptoms 2020–25 and is author of two books on CBT for menopausal symptoms with Melanie Smith. All other authors declare no conflicts of interest., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

The potential risk for mental health conditions over the menopause transition shapes women's expectations and informs putative physiological mechanisms regulating women's mental health. We review evidence from prospective studies reporting on associations between mental health conditions and the menopause transition. Major depressive disorder and the more prevalent subthreshold depressive symptoms are the most common conditions studied. We reviewed 12 prospective studies reporting depressive symptoms, major depressive disorder, or both over the menopause transition and found no compelling evidence for a universal increased risk for either condition. However, specific subgroups of participants, primarily defined by menopause-related risk factors (ie, vasomotor symptoms that are severe or disturb sleep, a long duration of the transition, or reproductive hormone dynamics) and psychosocial risk factors (eg, stressful life events), were vulnerable to depressive symptoms. The increased risk of major depressive disorder over the menopause transition appears predominantly in individuals with previous major depressive disorder. Greater focus on recognising risk factors in primary care is warranted. On the basis of scarce data, we found no compelling evidence that risk of anxiety, bipolar disorder, or psychosis is universally elevated over the menopause transition. Potential misattribution of psychological distress and psychiatric disorders to menopause could harm women by delaying accurate diagnosis and the initiation of effective psychotropic treatments, and by creating negative expectations for people approaching menopause. A paradigm shift is needed. We conclude with recommendations for the detection and treatment of depressive symptoms or major depressive disorder and strategies to promote good mental health over the menopause transition, while responsibly preparing and supporting those at risk., Competing Interests: Declaration of interests MSH declares consultation for Rightsteps UK. HJ declares grant funding from the National Institutes of Health (grant numbers U54AG062322 and R01MH128617), Pfizer, and Merck; and consulting for Bayer, Merck, and Hello Therapeutics. MH declares salary funding from the Australian National Health and Medical Research Council, support for meeting attendance from the UK National Institute for Health and Care Excellence, and the following roles: principal investigator for a clinical trial of salpingectomy vs salpingo-oophorectomy for prevention of ovarian cancer (TUBA-WISP II); board member for Breastscreen Victoria; editor for the Cochrane Collaboration; recipient of a fellowship from the Lundbeck Foundation (2022-23); site investigator for a clinical trial of a non-hormonal agent (Q-122) for vasomotor symptoms in patients with breast cancer (QUE Oncology, 2020-22); and site investigator for a clinical trial of a medical device for treating vaginal dryness (Madorra). All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Objective: This study aimed to advance understanding of vasomotor symptom (VMS) outcomes measurement using pooled data from three Menopause Strategies Finding Lasting Answers to Symptoms and Health (MsFLASH) trials., Methods: Participants self-reported VMS frequency, severity, and bother using daily diaries; completed standardized measures of VMS interference, insomnia severity, and sleep quality/disturbance; and completed four treatment satisfaction items. Analyses included descriptive statistics, Pearson correlations (baseline pooled sample, posttreatment pooled sample, posttreatment placebo only), t tests, and analysis of variance., Results: Participants were mostly postmenopausal (82.9%) and a mean of 54.5 years old. VMS frequency was fairly correlated with severity, bother, and interference for pooled baseline and placebo posttreatment samples ( r values = 0.21-0.39, P values < 0.001) and moderately correlated with severity, bother, and interference for pooled posttreatment ( r values = 0.40-0.44, P values < 0.001). VMS severity, bother, and interference were moderately correlated ( r values = 0.37-0.48, P values < 0.001), with one exception. VMS severity and bother were strongly correlated ( r values = 0.90-0.92, P values < 0.001). VMS interference was moderately correlated with insomnia ( r values = 0.45-0.54, P values < 0.001) and fairly to moderately correlated with sleep quality/disturbance ( r values = 0.31-0.44, P values < 0.001). Other VMS outcomes were weakly to fairly correlated with insomnia ( r values = 0.07-0.33, P values < 0.001 to < 0.05) and sleep quality/disturbance ( r values = 0.06-0.26, P values < 0.001 to > 0.05). Greater improvement in VMS and sleep over time was associated with higher treatment satisfaction ( P values < 0.001)., Conclusions: This pooled analysis advances understanding of VMS outcomes measurement and has implications for selecting measures and creating future research., Competing Interests: Financial disclosure/conflicts of interest: Dr. Carpenter received past consulting fees from the University of Wisconsin and Simumetrix SMX Health. Dr. Hunter receives funding from TurningPoint Charity and HelloTherapeutics. All other authors have no disclosures., (Copyright © 2023 by The Menopause Society.)

This study explored the use of Twitter to communicate about menopause. Tweets in English posted between January 2014 and December 2022 with the hashtag "menopause" were extracted. Total global tweets and those from the UK, USA, Australia and Canada were examined. Globally, there were 314,974 tweets about menopause over this period, with an annual average of 34,997. There were notable differences between countries, with a large increase in use in the UK in 2018 and 2019, a reducing trend in use in the USA with a smaller increase in 2018 and 2019, and low stable usage in Australia and Canada., Competing Interests: Declaration of competing interest CH is owner of the company Hardy People Ltd., and received honorarium payment by Pfizer unrelated to this work. ET is the owner of Example Coaching and Consulting Ltd. The authors MEH, AG and MSH declare that they have no competing interests., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Objectives: This study describes translation, cross-cultural adaptation, and validation of the Attitude Towards Menopause (ATM) scale in Persian., Methods: A standard process was followed for translation and cross-cultural adaptation of the ATM scale into Persian. The content validity index and content validity ratio were used to measure content validity. The construct validity was tested using exploratory factor analysis and confirmatory factor analysis. The average variance extracted and construct reliability were used to indicate convergent and discriminant validity, respectively. Internal consistency and test-retest reliability of the Persian ATM scale were assessed using Cronbach α and intraclass correlation coefficient (ICC)., Results: A revised version of the ATM scale, including 26 items assigned to seven factors, was obtained in exploratory factor analysis. The factors were interpreted as negative affect, postmenopausal recovery, control of symptoms, sexuality, psychological losses, unpleasant confrontation, and menstrual freedom, explaining 66.18% of the total variance. The factor structure of the scale was confirmed using confirmatory factor analysis (Comparative Fit Index = 0.90, Tucker-Lewis Index = 0.88, Goodness-of-Fit Index = 0.90, Adjusted Goodness-of-Fit Index = 0.86, Root Mean Square Error of Approximation = 0.07, χ2 / df = 4.56). The values of Cronbach α coefficient and ICC indicated an acceptable level of reliability ( α = 0.70, ICC = 0.89). The construct reliability for all factors was more than or equal to 0.7 except for psychological losses, indicating good discriminating validity. The values of average variances extracted for subscales varied from 0.48 to 0.99, representing adequate convergent validity., Conclusions: The Persian version of the ATM scale is a reliable and valid tool to evaluate the attitudes of Iranian women toward menopause., Competing Interests: Financial disclosure/conflicts of interest: M.S.H. receives funding from Turning Point UK Charity for consultation on menopause solutions and book royalties from Routledge. The other authors have nothing to disclose., (Copyright © 2023 by The North American Menopause Society.)

Background: Androgen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clinical response, it is associated with troublesome side effects including hot flushes and night sweats (HFNS). HFNS can be both frequent and severe and can have a significant impact on quality of life (QoL). They can occasionally be so debilitating that patients stop ADT altogether, despite the increased risk of disease relapse or death. Previous research has found that guided self-help cognitive behavioural therapy (CBT) can be effective in reducing HFNS due to ADT when delivered by a clinical psychologist. MANCAN2 aims test whether we can train the existing NHS Prostate Cancer Nurse Specialist (CNS) team to deliver guided self-help CBT and whether it is effective in reducing the impact of HFNS in men undergoing ADT., Methods: MANCAN2 is a phase III multicentre randomised controlled trial and process evaluation. Between 144 and 196 men with prostate cancer who are currently receiving ADT and are experiencing problematic HFNS will be individually randomised in a 1:1 ratio in groups of 6-8 participants to either treatment as usual (TAU) or participation in the guided self-help CBT intervention plus TAU. A process evaluation using the normalisation process theory (NPT) framework will be conducted, to understand the CNS team's experiences of delivering the intervention and to establish the key influencers to its implementation as a routine practice service. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost-effectiveness of the intervention and participant adherence to the trial intervention will also be assessed., Discussion: MANCAN2 will advance the program of work already conducted in development of management strategies for HFNS. This research will determine whether the severity of ADT-induced HFNS in men with prostate cancer can be reduced by a guided self-help CBT intervention, delivered by the existing NHS prostate cancer CNS team, within a multicentre study. The emphasis on this existing team, if successful, should facilitate translation through to implementation in routine practice., Trial Registration: ISRCTN reference 58720120 . Registered 13 December 2022., (© 2023. The Author(s).)

Competing Interests: Financial disclosure/conflicts of interest: None reported.

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following: MH has been an expert witness in 2020 for a public health authority in New South Wales Australia and topic expert for 2022 update of the NICE menopause guidelines. She was site investigator for a study of a non-hormonal agent for vasomotor symptoms after breast cancer funded by Que Oncology and for a trial of a device to treat vaginal dryness funded by Madorra. MSH is author of three books on cognitive behaviour therapy for menopausal symptoms and has a contract with Turning Point UK to develop support for women with menopausal symptoms and received a research grant from Wellbeing of Women to evaluate the MENO-kit, a workplace tool for menopause in the workplace. NS is on the scientific advisory board for Menogenix and Astellas and consultant for Ansh Labs. She has grant support to the University of Colorado from Menopgenix. SH is president of the Society for Reproductive Investigation and on the programme committee of the North American Menopause Society. JU was president of the Society for Menstrual Cycle Research, 2019-2021 and is president of the Australian Society for Psycho-social Obstetrics and Gynaecology.

Objective: Up to 50% of women prescribed tamoxifen do not take it as prescribed for the full duration, which increases risk of recurrence and mortality. The current paper describes the development of a self-management intervention aiming to improve adherence in breast cancer survivors taking tamoxifen., Methods: The intervention was developed following an Intervention Mapping approach. The content of the intervention was determined by theories of health behaviour and empirical evidence. Development was an iterative process involving input from expert researchers, clinicians and patient representatives., Results: The intervention was designed to improve both intentional and unintentional non-adherence. Key features included modifying unhelpful illness and treatment beliefs, improving confidence for coping with side effects and developing strategies for remembering to take tamoxifen., Conclusion: Intervention Mapping proved a useful tool for developing an intervention which is grounded in theory and empirical evidence. The intervention has the potential to improve adherence in breast cancer survivors but needs to be trialled before the effectiveness of the intervention can be determined.

Objective: Genitourinary symptoms, such as vaginal dryness and pain with sex, are commonly experienced by postmenopausal women. Comparing treatments for these genitourinary symptoms are restricted by the use of different outcome measures in clinical trials and the omission of outcomes, which may be relevant to women. The aim of this project was to develop a Core Outcome Set (COS) to be reported in clinical trials of treatments for genitourinary symptoms associated with menopause., Methods: We performed a systematic review of randomized controlled trials of treatments for genitourinary symptoms associated with menopause and extracted their outcomes. This list was refined and entered into a two-round modified Delphi survey, which was open to clinicians, researchers, and postmenopausal women from November 2019 to March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." The final COS was determined following two international consensus meetings., Results: A total of 26 unique outcomes were included in the Delphi process, which was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to the Delphi scores to categorize outcomes by importance, which informed the e consensus meetings, attended by 43 participants from 21 countries. The final COS includes eight outcomes: (1) pain with sex, (2) vulvovaginal dryness, (3) vulvovaginal discomfort or irritation, (4) discomfort or pain when urinating, (5) change in most bothersome symptom, (6) distress, bother or interference of genitourinary symptoms, (7) satisfaction with treatment, (8) side effects of treatment., Conclusion: These eight core outcomes reflect the joint priorities of postmenopausal women, clinicians, and researchers internationally. Standardized collection and reporting of these outcomes in clinical trials will facilitate the comparison of different treatments for genitourinary symptoms, advance clinical practice, and ultimately improve outcomes for symptomatic women., (Copyright © 2021 by The North American Menopause Society.)

Objective: Vasomotor symptoms (VMS) (hot flashes and night sweats) affect most women over the menopause transition. Comparing the safety and effectiveness of treatments for vasomotor symptoms is limited by the use of inconsistent outcome measures, and uncertainty as to which outcomes are most important to symptomatic women. To address this, we have developed a Core Outcome Set (COS) for use in clinical trials of treatments for VMS., Methods: We systematically reviewed the primary outcomes measured in randomized controlled trials of treatments for VMS. These were refined and entered into a two-round modified Delphi survey completed by clinicians, researchers, and postmenopausal women between November 2019 and March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." Two international consensus meetings were held to finalize the COS., Results: Based on the systematic review, 13 separate outcomes were included in the Delphi process. This was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to categorize importance scores obtained during Round 2 of the Delphi survey. These informed discussions at the consensus meetings which were attended by 56 participants from 28 countries. The final COS includes six outcomes: 1) frequency of VMS, 2) severity of VMS, 3) distress, bother or interference caused by VMS, 4) impact on sleep, 5) satisfaction with treatment, and 6) side-effects of treatment., Conclusion: Implementation of this COS will: better enable research studies to accurately reflect the joint priorities of postmenopausal women, clinicians and researchers, standardize outcome reporting, and facilitate combining and comparing results from different studies, and ultimately improve outcomes for women with bothersome VMS., Competing Interests: Financial disclosure/conflicts of interest: S.L., S.I., M.C., R.B., H.R., K.G., U.J., S.K., B.V.K., J.S., and M.S.H. declare no disclosures/conflicts of interest., (Copyright © 2021 by The North American Menopause Society.)

Most women experience some premenstrual symptoms during their reproductive years. Yet, this is an under-researched health issue, particularly in the context of work. This study aimed to: (i) understand the prevalence and severity of premenstrual symptoms experienced by working females, and their association with key work outcomes; (ii) explore factors that may be influencing these symptoms and their severity; and (iii) examine how organizations might help staff with premenstrual symptoms that may be impacting their working lives. An online, anonymous survey collected quantitative and qualitative data from 125 working women in the UK. Over 90% of the sample reported some premenstrual symptoms; 40% experienced premenstrual symptoms moderately or severely. Higher symptom severity was significantly ( p < 0.05) associated with poor presenteeism, intention to reduce working hours, and higher work absence (time off work, being late, leaving early). Moderate/severe symptoms were significantly associated with several individual-related variables: lower perceived general health, higher alcohol consumption, poorer sleep quality, anxiety, depression, hormonal contraception, and using fewer coping approaches towards premenstrual symptoms (avoiding harm, adjusting energy levels); and work-related variables: poorer work-life balance, lower levels of psychological resilience, higher perceived work demands, less control over work. Disclosure of premenstrual symptoms and sickness absence because of premenstrual symptoms was very low, typically because of perceptions of appropriateness as a reason for work absence, gender of line managers (male), and it being a personal or embarrassing topic. Staff with moderate to severe premenstrual symptoms were statistically more likely to disclose reason for absence than those with milder symptoms. Recommendations and suggestions for employers and line managers include the need to train staff to improve knowledge about women's experience of premenstrual symptoms, to be able to communicate effectively with women and to provide tailored support and resources for those who need it. Implications for future research, policy and practice are discussed.

Purpose: Internet-based cognitive behavioral therapy (iCBT), with and without therapist support, is effective in reducing treatment-induced menopausal symptoms and perceived impact of hot flushes and night sweats (HF/NS) in breast cancer survivors. The aim of the current study was to evaluate the cost-utility, cost-effectiveness, and budget impact of both iCBT formats compared to a waiting list control group from the Dutch healthcare perspective., Methods: A Markov model was constructed with a 5-year time horizon. Costs and health outcomes were measured alongside a randomized controlled clinical trial and included quality-adjusted life years (QALYs), overall levels of menopausal symptoms, and perceived impact of HF/NS. Uncertainty was examined using probabilistic and deterministic sensitivity analyses, together with a scenario analysis incorporating a different perspective., Results: iCBT was slightly more expensive than the waiting list control, but also more effective, resulting in incremental cost-utility ratios of €23,331/QALY and €11,277/QALY for the guided and self-managed formats, respectively. A significant reduction in overall levels of menopausal symptoms or perceived impact of HF/NS resulted in incremental costs between €1460 and €1525 for the guided and €500-€753 for the self-managed format. The estimated annual budget impact for the Netherlands was €192,990 for the guided and €74,592 for the self-managed format., Conclusion: Based on the current trial data, the results indicate that both guided and self-managed iCBT are cost-effective with a willingness-to-pay threshold of well below €30,000/QALY. Additionally, self-managed iCBT is the most cost-effective strategy and has a lower impact on healthcare budgets.

Objective: Previous research has shown that up to 50% of breast cancer survivors prescribed tamoxifen do not take it as recommended, which is associated with increased risk of recurrence and mortality. Little research has attempted to identify modifiable psychosocial factors associated with tamoxifen nonadherence. This study aimed to examine how tamoxifen adherence rates change over a year and to identify modifiable predictors of nonadherence., Method: Three hundred and forty-five breast cancer survivors who were in their first year of tamoxifen prescription were sent questionnaires at 4 points over a 12-month period. Questionnaires assessed demographic and clinical factors, side effects, beliefs about the illness and medication, social support, distress and tamoxifen adherence. Adherence was assessed using the Medication Adherence Rating Scale. Latent Growth Modeling was used to identify predictors of tamoxifen nonadherence., Results: Reported rates of nonadherence increased over time (37-48%). Several demographic, clinical, and psychosocial variables were associated with nonadherence. Women who were nonadherent were more likely to be from a minority ethnic group, to have more negative medication beliefs and to have lower confidence in their ability to take tamoxifen., Conclusions: These demographic and clinical variables can be used to identify women at higher risk of nonadherence. The modifiable psychosocial variables can be used as the basis for psychological interventions to improve adherence in this population. Interventions should focus on both intentional and unintentional nonadherence. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Purpose: We evaluated the effect of Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, on the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms (primary outcomes), sleep quality, HF/NS frequency, sexual functioning, psychological distress, and health-related quality of life in breast cancer survivors with treatment-induced menopausal symptoms., Patients and Methods: We randomly assigned 254 breast cancer survivors to a therapist-guided or a self-managed iCBT group or to a waiting list control group. The 6-week iCBT program included psycho-education, behavior monitoring, and cognitive restructuring. Questionnaires were administered at baseline and at 10 weeks and 24 weeks postrandomization. We used mixed-effects models to compare the intervention groups with the control group over time. Significance was set at P < .01. An effect size (ES) of .20 was considered small, .50 moderate and clinically significant, and .80 large., Results: Compared with the control group, the guided and self-managed iCBT groups reported a significant decrease in the perceived impact of HF/NS (ES, .63 and .56, respectively; both P < .001) and improvement in sleep quality (ES, .57 and .41; both P < .001). The guided group also reported significant improvement in overall levels of menopausal symptoms (ES, .33; P = .003), and NS frequency (ES, .64; P < .001). At longer-term follow-up (24 weeks), the effects remained significant, with a smaller ES for the guided group on perceived impact of HF/NS and sleep quality and for the self-managed group on overall levels of menopausal symptoms. Additional longer-term effects for both intervention groups were found for hot flush frequency., Conclusion: iCBT, with or without therapist support, has clinically significant, salutary effects on the perceived impact and frequency of HF/NS, overall levels of menopausal symptoms, and sleep quality.

Objective: Seventy percent of postmenopausal women experience vasomotor symptoms, which can be highly disruptive and persist for years. Hormone therapy and other treatments have variable efficacy and/or side effects. Neurokinin B signaling increases in response to estrogen deficiency and has been implicated in hot flash (HF) etiology. We recently reported that a neurokinin 3 receptor (NK3R) antagonist reduces HF in postmenopausal women after 4 weeks of treatment. In this article we report novel data from that study, which shows the detailed time course of this effect., Methods: Randomized, double-blind, placebo-controlled, single-center, crossover trial of an oral NK3R antagonist (MLE4901) for vasomotor symptoms in women aged 40 to 62 years, experiencing ≥7 HF/24 hours some of which were reported as bothersome or severe (Clinicaltrials.gov NCT02668185). Thirty-seven women were randomized and included in an intention-to-treat analysis. To ascertain the therapeutic profile of MLE4901, a post hoc time course analysis was completed., Results: By day 3 of treatment with MLE4901, HF frequency reduced by 72% (95% CI, -81.3 to -63.3%) compared with baseline (51 percentage point reduction compared with placebo, P < 0.0001); this effect size persisted throughout the 4-week dosing period. HF severity reduced by 38% compared with baseline by day 3 (95% CI, -46.1 to -29.1%) (P < 0.0001 compared with placebo), bother by 39% (95% CI, -47.5 to -30.1%) (P < 0.0001 compared with placebo), and interference by 61% (95% CI, -79.1 to -43.0%) (P = 0.0006 compared with placebo); all continued to improve throughout the 4-week dosing period (to -44%, -50%, and -70%, respectively by day 28, all P < 0.0001 compared with placebo)., Conclusions: NK3R antagonism rapidly relieves vasomotor symptoms without the need for estrogen exposure.

Objective: The aim of the study was to examine the efficacy of an unguided, self-help cognitive behavior therapy (SH-CBT) booklet on hot flush and night sweat (HFNS) problem rating, delivered in a work setting., Methods: Women aged 45 to 60 years, having 10 or more problematic HFNS a week, were recruited to a multicenter randomized controlled trial, via the occupational health/human resources departments of eight organizations. Participants were 1:1 randomized to SH-CBT or no treatment waitlist control (NTWC). The primary outcome was HFNS problem rating; secondary outcomes included HFNS frequency, work and social adjustment, sleep, mood, beliefs and behaviors, and work-related variables (absence, performance, turnover intention, and work impairment due to presenteeism). Intention-to-treat analysis was used, and between-group differences estimated using linear mixed models., Results: A total of 124 women were randomly allocated to SH-CBT (n = 60) and NTWC (n = 64). 104 (84%) were assessed for primary outcome at 6 weeks and 102 (82%) at 20 weeks. SH-CBT significantly reduced HFNS problem rating at 6 weeks (SH-CBT vs NTWC adjusted mean difference, -1.49; 95% CI, -2.11 to -0.86; P < 0.001) and at 20 weeks (-1.09; 95% CI, -1.87 to -0.31; P < 0.01). SH-CBT also significantly reduced HFNS frequency, improved work and social adjustment; sleep, menopause beliefs, HFNS beliefs/behaviors at 6 and 20 weeks; improved wellbeing and somatic symptoms and reduced work impairment due to menopause-related presenteeism at 20 weeks, compared with the NTWC. There was no difference between groups in other work-related outcomes., Conclusions: A brief, unguided SH-CBT booklet is a potentially effective management option for working women experiencing problematic HFNS.

Background: There is growing research interest in the question of whether menopause impacts upon mid-aged women's work outcomes, but the evidence to date is inconclusive. This paper examines whether: (i) menopausal status, and experience of hot flushes and night sweats (HFNS), and whether (ii) work stress and work environment, are associated with work outcomes (absenteeism, job performance, turnover intention, and intention to leave the labor force)., Methods: An online survey (sociodemographic, menopause, health, well-being and aspects of work) was completed by 216 (pre-, peri- and postmenopausal) women aged 45-60 years., Results: Work outcomes were not associated with menopausal status but were significantly associated with job stress and aspects of the work environment, such as demand, control and support. HFNS presence, frequency and problem-rating were not significantly associated with work outcomes. HF problem rating at work was significantly associated with intention to leave the labor force, after controlling for age (F(2,101), 6.742, p  = .002)., Conclusions: The main predictors of work outcomes in this sample of mid-aged women were aspects of the working environment (particularly role clarity and work stress). Menopausal status was not associated with work outcomes but having problematic hot flushes at work was associated with intention to stop working. These results challenge assumptions about the menopause transition by providing evidence that the menopause does not impact on women's self-reported work performance and absence. However, support for women with problematic HFNS at work may be beneficial, as might addressing working environment issues for mid-aged women., Competing Interests: Ethical approval was given by Kings College London Ethical Review Committee (reference number: HR-15/16–2492).All participants gave their consent to participate and publish the results.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.

Purpose: Many breast cancer patients experience (severe) menopausal symptoms after an early onset of menopause caused by cancer treatment. The aim of this study was to assess the cost-effectiveness of cognitive behavioral therapy (CBT) and physical exercise (PE), compared to a waiting list control group (WLC)., Methods: We performed a cost-effectiveness analysis from a healthcare system perspective, using a Markov model. Effectiveness data came from a recent randomized controlled trial that evaluated the efficacy of CBT and PE. Cost data were obtained from relevant Dutch sources. Outcome measures were incremental treatment costs (ITCs) per patient with a clinically relevant improvement on a measure of endocrine symptoms, the Functional Assessment of Cancer Therapy questionnaire (FACT-ES), and on a measure of hot flushes, the Hot Flush Rating Scale (HFRS), and costs per quality-adjusted life years (QALY) gained over a 5-year time period., Results: ITCs for achieving a clinically relevant decline on the FACT-ES for one patient were €1,051 for CBT and €1,315 for PE, compared to the WLC. The corresponding value for the HFRS was €1,067 for CBT, while PE was not more effective than the WLC. Incremental cost-utility ratios were €22,502/QALY for CBT and €28,078/QALY for PE., Conclusion: CBT is likely the most cost-effective strategy for alleviating treatment-induced menopausal symptoms in this population, followed by PE. The outcomes are sensitive to a reduction of the assumed duration of the treatment effect from 5 to 3 and 1.5 years., Implications for Cancer Survivors: Patients can be prescribed CBT or, based on individual preferences, PE.

Objective: Hot flushes and night sweats (HFNS) are commonly experienced by women during the menopause transition and are particularly problematic for approximately 25% having negative impact on their quality of life. We previously developed a cognitive model of HFNS, which outlines potential predictors of HFNS. This study aims to test the model by investigating the relationships between personality characteristics, perceived stress, mood, HFNS beliefs and subjective and physiological measures of menopausal HFNS., Methods: 140 women (menopause transition or postmenopausal) who were experiencing at least 10 HFNS per week for at least a month, completed assessment interviews, including questionnaires assessing optimism, somatic amplification, perceived stress, depressed mood, anxiety, HFNS beliefs and HFNS frequency, problem-rating and 24-hour sternal skin conductance monitoring. Structural equation models (SEM) were used to investigate the optimum predictive model for HFNS Frequency and HFNS Problem-Rating., Results: On average 63 HFNS per week and moderately problematic HFNS were reported. The physiological measure of HFNS frequency was not associated with socio-demographic variables, personality or mood. The final SEM explained 53.2% of the variance in problem rating. Stress, anxiety and somatic amplification predicted HFNS problem rating but only via their impact on HFNS beliefs; HFNS frequency, smoking and alcohol intake also predicted HFNS problem rating., Conclusions: Findings support the influence of psychological factors on experience of HFNS at the level of symptom perception and cognitive appraisal of HFNS., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objectives: Hot flushes and night sweats (HF/NS) are experienced by 60-70% of menopausal women and are problematic for approximately 20-25%. Potential health risks associated with hormone-replacement therapy (HT) have led to a significant decline in HT use. There is therefore a need for safe, effective and evidence-based alternative treatments for menopausal symptoms. Previous exploratory work suggests that cognitive-behavioural therapy (CBT) is acceptable and effective for women with HF/NS during natural menopause and following breast-cancer treatment. This randomised controlled trial compares the effectiveness of Group CBT and Guided Self-Help CBT with no treatment control in reducing HF/NS Problem Rating and Frequency at post-treatment (main outcome) and at 6 months postrandomisation., Methods and Analysis: 120 women, with 10 or more HF/NS a week for a month, are recruited from GP surgeries and the local community of South London. They are randomised to either 4 weeks of Group CBT, 4 weeks guided Self-Help CBT or no treatment control. Participants attend a clinical interview, and complete baseline questionnaire measures of HF/NS Problem Rating and Frequency (primary outcomes), mood, quality of life, self-esteem, hot-flush beliefs and behaviours, optimism and somatic amplification, and undergo 24 h sternal skin conductance monitoring (SCC-physiological measure of HF/NS) (secondary outcomes). Post-treatment measures (SSC, questionnaires and use of medical services) are collected 6-8 weeks later and follow-up measures (questionnaires and a use of medical services measure) at 6 months postrandomisation., Ethics and Dissemination: Ethical registration was granted by King's College London Research Ethics Committee (ref: PNM/08/09-42). All participants provide written informed consent. If treatment is successful, a Group CBT training manual and training sessions for health professionals, and a Self-Help CBT book will be published. Other CBT delivery options will also be examined (including Computerised Self-Help CBT and Group CBT workshops). Clinical Trial Registration Number ISRCTN57302613.

Hot flushes and night sweats (HF/NS) are commonly experienced by mid-aged women during the menopause transition. They affect approximately 70% of women but are regarded as problematic for 15-20% largely due to physical discomfort, distress, social embarrassment, and sleep disturbance. There is a need for effective and acceptable nonmedical treatments for menopausal symptoms due to the declining use of hormone therapy (HT) following publication of the Women's Health Initiative and other prospective studies which associated HT use with increased risk of stroke and breast cancer. HF/NS are an example of a physiological process embedded within, and moderated by, psychological processes, as evidenced by discrepancies between subjective experiences and physiologically measured symptoms. We describe a cognitive model of menopausal hot flushes that can explain symptom perception, cognitive appraisal, and behavioral reactions to symptoms. Theoretically, the model draws on symptom perception theory, self-regulation theory, and cognitive behavioral theories. The model can be used to identify the variables to target in psychological interventions for HF/NS and to aid understanding of possible mediating factors. As part of Phase II intervention development, we describe a cognitive behavioral treatment which links the bio-psycho-social processes specified in the model to components of the intervention., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Objective: To evaluate a group cognitive behavioural intervention to alleviate menopausal symptoms in women who have had treatment for breast cancer., Methods: A single group design was used with pre- and post-treatment assessment and a 3-months follow-up. Seventeen women who had completed active breast cancer treatment were treated. Following a 2-week daily diary assessment they were offered 6 (90 min) weekly sessions of Group cognitive behaviour therapy (CBT). The CBT included information and discussion, relaxation and paced breathing and CBT to reduce stress and manage hot flushes (HF), night sweats (NS) and sleep. The primary outcome measure was Hot Flush Frequency and Hot Flush Problem Rating; secondary outcomes included the Women's Health Questionnaire (WHQ) and health-related quality of life (SF 36). Beliefs about HF were monitored in order to examine the effects of cognitive therapy., Results: HF and NS reduced significantly following treatment (38% reduction in frequency and 49% in problem rating) and improvements were maintained at 3 months follow-up (49% reduction in frequency and 59% in problem rating). Depressed mood, anxiety and sleep (WHQ) significantly improved, as did aspects of quality of life (SF 36) (emotional role limitation, energy/vitality and mental health). There was a significant reduction in negative beliefs about HF, NS and sleep following CBT., Conclusions: These results suggest that CBT delivered in groups might offer a viable option for women with troublesome menopausal symptoms following breast cancer treatment, but further controlled trials are needed., (Copyright (c) 2008 John Wiley & Sons, Ltd.)

The Women's Health Questionnaire (WHQ) is a measure of mid-aged women's emotional and physical health. Since its publication in 1992 the WHQ has been widely used in multinational clinical trials, in epidemiological studies as well as in the evaluation of non-medical treatments. In particular the WHQ has been included as a quality of life measure in trials of hormonal preparations for peri and post menopausal women and in studies using a variety of preventative interventions for mid-aged and older women. The questionnaire was developed in English and standardised on a sample of women aged 45-65 years. It is reliable, has good concurrent validity and is sensitive to detecting change, and is available in 27 languages. The range of subscales included in the WHQ enable a detailed assessment of dimensions of emotional and physical health, such as depression, anxiety, sleep problems, somatic symptoms, with optional subscales for menstrual problems and sexual difficulties. The WHQ is the first measure to be included in the MAPI Research Institute's database, the International Health-related Quality of Life Outcomes Database (IQOD). Drawing upon data from international studies this project aims to produce reference values for cross-culturally valid, reliable and responsive quality of life instruments. In addition to this work, a revised shorter version of the WHQ is currently being developed.

Objective: The risk of developing breast cancer increases with advancing age. There is evidence to suggest that delayed help-seeking for breast cancer symptoms is associated with poorer survival and that older women are more likely to delay in seeking help for such symptoms. This study examined age differences in beliefs regarding breast cancer and intentions to seek medical care for breast symptoms in a general population sample., Method: A general population sample of 546 women completed a postal questionnaire about beliefs regarding the symptoms, causes and outcomes associated with breast cancer, attitudes towards help-seeking and beliefs about one's ability to seek help. The questionnaire was based on components of the self-regulation model and the theory of planned behaviour. Help-seeking intention was measured by asking participants to rate the likelihood of visiting a general practitioner for a range of breast symptoms. The subscales of each model were entered as predictors of intention to seek help for breast symptoms in a series of hierarchical multiple regression analyses performed for each age group., Results: The inability to correctly identify a range of potential breast cancer symptoms (identity subscale) was a significant predictor of intention delay in seeking help across all age groups. For women aged 35-54, negative attitudes toward medical help-seeking for breast symptoms (beta = 1.82, P < .05) and a negative belief in one's ability to seek help (perceived behavioural control) were additional predictors of intention not to seek help (beta = 0.229, P < .001). Holding negative beliefs about the consequences associated with breast cancer (i.e., that the disease could be potentially disabling or disfiguring) was found to be an important additional predictor of potential delay in help-seeking among women aged over 65 years (beta = 0.210, P < .05)., Conclusion: Correct identification of potential breast cancer symptoms was universally important in predicting intention to seek medical care across age groups. However, additional beliefs differentially influenced help-seeking intention within different age groups. Preliminary findings suggest that interventions to reduce delay behaviour in help-seeking for breast symptoms should inform women of the diversity of breast cancer symptoms, advances in the management of breast cancer and provide advice on how to obtain help for breast cancer symptoms., (Copyright 2003 Elsevier Science Inc.)

Objectives: To investigate (i) the differential changes in premenstrual symptoms, mood, cognitions, and coping strategies during two treatments [cognitive-behavioural therapy (CBT) and fluoxetine] for premenstrual dysphoric disorder (PMDD) and (ii) the characteristics of those with good vs. poor outcome post treatment and at 1 year follow-up., Methods: Premenstrual symptoms, mood (Hospital Anxiety and Depression Scale, HADS), causal attributions, and use of cognitive and behavioural coping strategies were examined during 6 months of both treatments. The two treatment groups were then combined and divided on the basis of good vs. poor outcome posttreatment and at 1 year follow-up. Baseline measures were used to predict posttreatment outcome, and baseline and posttreatment measures were examined when attempting to predict outcome at 1 year follow-up., Results: Both treatments were equally effective at the end of 6 months (prospective daily diary measure). Fluoxetine treatment had a more rapid effect and greater impact upon anxiety symptoms, while CBT was associated with increased use of cognitive and behavioural coping strategies and a shift from a biomedical to a biopsychosocial causal attribution of premenstrual symptoms. Depressed mood at baseline assessment was associated with poorer response to both treatments, and learning active behavioural coping strategies was associated with a good outcome at 1 year follow-up., Conclusion: These results provide evidence of differential treatment effects of fluoxetine and CBT for PMDD and offer information that will enhance clinical decision-making., (Copyright 2002 Elsevier Science Inc.)