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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.)

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.)

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.)

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: 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.)

Objectives: Results from our recently conducted randomized controlled trial (RCT) indicated that Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, is effective in reducing the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms in breast cancer survivors with treatment-induced menopausal symptoms., Study Design: We used data of 235 women and compared the iCBT groups combined (n = 156) with the control group (n = 79). Bootstrapped multiple regression analyses with interaction terms (group x potential moderator) or indirect effects (mediation pathway) were conducted., Main Outcome Measures: Reductions in perceived impact of HF/NS and overall levels of menopausal symptoms., Results: Women with lower levels of education benefited most from the iCBT. Age, time since diagnosis, current endocrine treatment, oophorectomy, frequency of HF/NS, and psychological distress did not moderate the treatment effects. Factors that mediated treatment effects were the development of healthier beliefs about experiencing hot flushes in a social context, about the impact of night sweats on sleep and daily functioning, and about the ability to control and cope with hot flushes. The acquisition of behavioral coping strategies and decreased psychological distress did not mediate treatment effects., Conclusion: The results suggest that women with lower levels of education may benefit most from the current iCBT program, with or without therapist support. The development of healthier HF/NS beliefs contribute significantly to the observed positive effect of iCBT on the burden of menopausal symptoms., Clinical Trial Information: NCT02672189., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objectives: To develop and evaluate a 30-min online training for managers, in order to improve menopause-related knowledge, attitudes and confidence in having supportive discussions with women experiencing menopausal symptoms at work. The study also explored intentions and behaviour in terms of having conversations., Study Design: A prospective, pre-post design involved collecting data at three time points: pre-training, immediately after training, and four weeks post-training. Three UK organizations (one public, two private sector) participated. On-line questionnaires collected sociodemographic and background data. Qualitative and quantitative evaluation data were collected in post-intervention questionnaires. Paired t-tests and McNemar tests examined statistical differences pre- and post-training; thematic content analysis was performed on qualitative data., Main Outcome Measures: Menopause knowledge, attitudes and confidence in talking about the menopause at work, intentions, and actual behaviour., Results: 270 staff were invited and 98 consented to participate; 62 and 61 provided data immediately and 4 weeks post training, respectively. Compared to pre-training scores, statistically significant improvements were found in menopause-related knowledge, attitude (not viewing the menopause as an embarrassing topic to talk about at work), confidence in talking about the menopause with staff, and intentions to discuss menopause, at both follow-up assessments. Over 90% of respondents reported that they found the training useful and would recommend it to others., Conclusions: A brief menopause awareness training may be a feasible and effective way to help managers become more knowledgeable about menopause-related problems and more confident in discussing and exploring solutions with their staff., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Reclaim the Menopause is a community-based menopause course developed by Hands Inc. and supported by Hackney Learning Trust. The course provides evidence-based education, cognitive behaviour therapy and psychosocial support to promote menopause awareness, challenge stigma and increase self-management amongst menopausal women. Ethnicity was an important aspect of the work, as Hands Inc. was keen to reach women who might not otherwise access interventions. All course participants were Black British (as were two of the three facilitators). Course attendees reported reduced menopausal symptoms as well as improvements in mood and the quality of their lives.

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.

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

Introduction: Menopausal symptoms are frequent and severe in breast cancer survivors taking tamoxifen; however, treatment options are limited for these patients as hormonal replacement therapy is contraindicated. This study aimed to explore the experience and attribution of menopausal symptoms and identify factors related to the experience of menopausal symptoms in women taking tamoxifen., Methods: Women who had been prescribed tamoxifen for a diagnosis of primary breast cancer were recruited from oncology clinics across England and from online advertisements. Seven hundred and forty women completed questionnaires assessing illness perceptions, social support, mood and symptom duration/severity., Results: Eighty-four percent of women had experienced hot flushes and 80% experienced night sweats; of these, 60% experienced severe symptoms. Symptoms persisted throughout 5 years of treatment and were mainly attributed to tamoxifen. Logistic regressions showed that depressive symptoms, previous chemotherapy and being employed were associated with increased odds of hot flush or night sweat prevalence. Symptom severity was associated with depression, being employed and attributing symptoms to tamoxifen., Discussion: These findings have clinical implications in terms of targeting women who are more at risk and offering non-hormonal treatment options, such as cognitive behavioural therapy, to help women to develop self-management strategies for coping with menopausal symptoms.

Objectives: To explore women's perspectives on what employers and managers should and should not do in relation to women going through the menopause., Methods: An online questionnaire was used to collect qualitative data in a cross-sectional study of working women. Three open-ended questions asked peri- and post-menopausal women, aged 45-65 years: (i) what they thought employers could do, or should do, to help menopausal women who may be experiencing difficult menopausal symptoms at work; (ii) how managers should behave; and (iii) how managers should not behave towards women going through the menopause., Results: 137 women responded to the open questions in the survey. An inductive thematic analysis was conducted and three overarching themes emerged. Theme 1 related to employer/manager awareness, specifically to knowledge about the menopause and awareness of how the physical work environment might impact on menopausal women. Theme 2 related to employer/manager communication skills and behaviors, specifically those considered helpful and desired and those considered unhelpful and undesired. Theme 3 described employer actions, involving staff training and raising awareness, and supportive policies such as those relating to sickness absence and flexible working hours., Conclusions: The menopause can be difficult for some women to deal with at work, partly due to the working environment. To our knowledge, this is the first study to explore women's descriptions of how they would like to be treated by employers/managers, and what would be helpful and unhelpful. The results have clear implications for communication about menopause at work and for employer-level policy and practice., (Copyright © 2017. Published by Elsevier B.V.)

Background: Hot flushes affect 70% of menopausal women and often severely impact physical, psychosocial, sexual, and overall wellbeing. Hormone replacement therapy is effective but is not without risk. Neurokinin B signalling is increased in menopausal women, and has been implicated as an important mediator of hot flushes., Methods: This phase 2, randomised, double-blind, placebo-controlled, single-centre, crossover trial assessed the effectiveness of an oral neurokinin 3 receptor antagonist (MLE4901) on menopausal hot flushes. Eligible participants were healthy women aged 40-62 years, having seven or more hot flushes in every 24 h of which some were reported as being severe or bothersome, who had not had a menstrual period for at least 12 months, and who had not been taking any medication shown to improve menopausal flushes in the preceding 8 weeks. Participants received 4 weeks of MLE4901 (40 mg, orally, twice daily) and placebo (orally, twice daily) in random order separated by a 2 week washout period. Randomisation was completed by a central computer, and participants were allocated to treatment number in numerical order. The primary outcome was the total number of hot flushes during the final week of both treatment periods. Analyses were by intention to treat and per protocol using generalised linear mixed models and standard crossover analysis. All analyses were prespecified in the study protocol. The trial is registered at ClinicalTrials.gov, number NCT02668185., Findings: 68 women were screened between Feb 3 and Oct 10, 2016, of which 37 were randomly assigned and included in an intention-to-treat analysis. 28 participants completed the trial and were included in a per-protocol analysis. MLE4901 significantly reduced the total weekly number of hot flushes by 45 percentage points (95% CI 22-67) compared with the placebo (intention-to-treat adjusted means: placebo 49·01 [95% CI 40·81-58·56] vs MLE4901 19·35 [15·99-23·42]; adjusted estimate of difference 29·66 [17·39-42·87], p<0·0001). Treatment was well tolerated. Three participants developed a transaminase rise (alanine aminotransferase 4·5-5·9 times the upper limit of normal) with a normal bilirubin 28 days after starting MLE4901, which normalised within 90 days., Interpretation: Treatment with a neurokinin 3 receptor antagonist (MLE4901) could be practice changing as it safely and effectively relieves hot flush symptoms without the need for oestrogen exposure. Larger scale studies of longer duration are now indicated., Funding: UK Medical Research Council and National Institute for Health Research., (Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.)

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.

Objectives: Cognitive behaviour therapy (CBT) has been found to reduce the impact of menopausal symptoms, hot flushes and night sweats. This study investigates the moderators and mediators of CBT for women who had problematic menopausal symptoms following breast cancer treatment., Study Design: Analysis of 96 patients with breast cancer induced menopausal symptoms recruited to the MENOS1 trial; 47 were randomly assigned to Group CBT and 49 to usual care. Questionnaires were completed at baseline, 9 and 26 weeks post randomisation. Potential moderators and mediators, including sociodemographic, clinical and psychological factors, of the treatment effect on the primary outcome were examined., Main Outcome Measure: Hot Flush Problem Rating., Results: CBT was effective at reducing problem rating at 9 weeks regardless of age, BMI, time since breast cancer diagnosis, menopausal status at time of diagnosis, or type of cancer treatment (radiotherapy or chemotherapy or endocrine treatment). The treatment effect was significantly greater in women not receiving chemotherapy, those with higher levels of psychological distress at baseline and for non-white women. Beliefs about control/coping with hot flushes were the main mediators of improvement in problem rating following CBT. Beliefs about hot flushes in a social context, depressed mood and sleep problems were also identified as mediators., Conclusions: These findings suggest that CBT is widely applicable for breast cancer patients who are experiencing treatment related menopausal symptoms, and that CBT works mainly by changing beliefs and improving mood and sleep., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Objectives: Perception of physical symptoms is an important factor in medical help-seeking. We aimed to examine both physiological and subjective measures of a commonly reported physical symptom-vasomotor symptoms (hot flushes and night sweats; HF/NS), and to investigate factors that might influence symptom perception, that is, concordance, over-reporting, and under-reporting of symptoms in healthy menopausal women., Methods: One hundred and forty women completed questionnaires assessing depressed mood, anxiety, stress, somatic symptoms, beliefs about HF/NS, and somatic amplification. Subjective and objective (24-h sternal skin conductance) measurements of HF/NS were obtained to assess concordance., Results: Thirty-seven percent of HF/NS were concordant while 47 and 16 % were under-reported and over-reported, respectively. Depressed mood, anxiety, somatic symptoms, and negative beliefs about HF/NS were associated with (higher) concordance, (less) under-, or (more) over-reporting. Negative beliefs about night sweats and sleep were the strongest predictors of concordance, whereas additional somatic symptoms and smoking predicted over-reporting., Conclusions: Just over one third of physiologically recorded HF/NS were perceived as hot flushes; under-reporting of symptoms was more common than over-reporting. Interestingly, women who were more accurate in detecting physiological HF/NS tended to report more psychological and somatic symptoms and negative beliefs about HF/NS. Both measures should be included as outcomes of clinical trials., (Copyright © 2014 Wiley Periodicals, Inc.)

Objectives: Group and Self-Help forms of Cognitive Behavioural Therapy (CBT) are effective treatment options for women with problematic menopausal hot flushes and night sweats (HF/NS). However, some women are unable to attend face-to-face sessions. This study investigates whether Self-Help CBT for HF/NS is as effective when rolled out to women living at a distance with minimal telephone guidance., Study Design: Forty-seven women completed a Self-Help CBT intervention (booklet and relaxation/paced breathing CD) during a 4-week period. They also received one 'guiding' telephone call from a clinical psychologist two weeks into treatment to provide support and discuss individual treatment goals. Questionnaires were collected at baseline, 6 weeks (post-treatment) and 3 months (follow-up) after the end of the intervention., Main Outcome Measures: HF/NS problem rating., Secondary Outcome Measures: HF/NS frequency, HF/NS beliefs and behaviours, sleep, anxiety and depressed mood., Results: There was a significant reduction in HF/NS problem-rating following the intervention which was maintained at follow-up. Moreover, women reported less frequent HF/NS along with further improvements in sleep quality, mood and HF/NS beliefs and behaviours., Conclusions: Telephone-guided Self-Help interventions might provide an effective way of widening access to CBT treatment for HF/NS., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Background: Evidence suggests that a high proportion of perimenopausal and postmenopausal women experience vasomotor symptoms (hot flushes/night sweats) that can be severe and disruptive and which are the principal reason for seeking medical intervention. Hormone therapy (HT) is known to be an effective treatment for troublesome hot flushes/night sweats but research has raised questions about the safety of HT and there have been negative high profile media reports about its use. Consequently many women are seeking alternatives and exercise might be one such option but there is a lack of high quality evidence on its effectiveness., Aims: This RCT initially aims to investigate the feasibility/acceptability of two exercise interventions identified from our previous preference study in 165 women, and if found to be feasible/acceptable, continue to recruit sufficient women (n=261) to examine the effect of these interventions on hot flushes/night sweats and other outcomes relevant to menopausal women., Method: We aim to recruit inactive perimenopausal and menopausal symptomatic women not using HT and randomise them to one of two exercise interventions or usual care for six months., Results: We will assess outcomes at baseline and 6 and 12 months from randomisation., Conclusion: We hope this RCT will contribute towards increasing the evidence regarding the question of whether exercise is an effective treatment for vasomotor symptoms in women not taking HT., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Background: There is a growing need for non-medical treatments for women experiencing problematic menopausal symptoms such as hot flushes and night sweats (HF/NS). A recent randomized control trial (RCT) (MENOS2) provides evidence of the effectiveness of Group CBT and Self-Help CBT for HF/NS., Aims: This study examines MENOS 2 participants' experience of the CBT treatments., Method: Twenty women who had experienced CBT for HF/NS (10 Group CBT and 10 Self-Help CBT) were interviewed at the end of the trial to explore how they experienced the treatment and its effects. The interviews were analysed using interpretative phenomenological analysis., Results: Women experienced both treatment formats as positive and helpful, increasing their ability to cope and their sense of control over HF/NS. Four super-ordinate themes were identified: making sense of symptom change, new ways of coping and regaining control, acknowledging and challenging the menopause taboo, and social interaction and support versus individual learning., Conclusions: These qualitative results are consistent with those of the main trial in that women found both CBT formats helpful in reducing the impact of HF/NS. However, the results also suggest possible mechanisms of change and provide useful information on women's responses to the different treatment components and formats.

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.)

Purpose: The purpose of our study was to evaluate the effect of cognitive behavioral therapy (CBT), physical exercise (PE), and of these two interventions combined (CBT/PE) on menopausal symptoms (primary outcome), body image, sexual functioning, psychological well-being, and health-related quality of life (secondary outcomes) in patients with breast cancer experiencing treatment-induced menopause., Patients and Methods: Patients with breast cancer reporting treatment-induced menopausal symptoms (N=422) were randomly assigned to CBT (n=109), PE (n=104), CBT/PE (n=106), or to a waiting list control group (n=103). Self-report questionnaires were completed at baseline, 12 weeks, and 6 months. Multilevel procedures were used to compare the intervention groups with the control group over time., Results: Compared with the control group, the intervention groups had a significant decrease in levels of endocrine symptoms (Functional Assessment of Cancer Therapy-Endocrine Symptoms; P<.001; effect size, 0.31-0.52) and urinary symptoms (Bristol Female Lower Urinary Tract Symptoms Questionnaire; P=.002; effect size, 0.29-0.33), and they showed an improvement in physical functioning (36-Item Short Form Health Survey physical functioning subscale; P=.002; effect size, 0.37-0.46). The groups that included CBT also showed a significant decrease in the perceived burden of hot flashes and night sweats (problem rating scale of the Hot Flush Rating Scale; P<.001; effect size, 0.39-0.56) and an increase in sexual activity (Sexual Activity Questionnaire habit subscale; P=.027; effect size, 0.65). Most of these effects were observed at both the 12-week and 6-month follow-ups., Conclusion: CBT and PE can have salutary effects on endocrine symptoms and, to a lesser degree, on sexuality and physical functioning of patients with breast cancer experiencing treatment-induced menopause. Future work is needed to improve the design and the planning of these interventions to improve program adherence.

Objective: The aim of this study was to examine the effectiveness of group cognitive behavioral therapy (CBT) and guided self-help CBT in reducing hot flush and night sweat (HF/NS) problem rating at 6 and 26 weeks after randomization., Methods: This was a randomized control trial of 140 women having 10 or more problematic HF/NS a week for at least a month. The primary outcome was HF/NS problem rating (1-10) at 6 weeks after randomization. Secondary outcomes were physiologically measured HF/NS at 6 weeks; HF/NS problem rating at 6 weeks; and frequency, mood (Women's Health Questionnaire), and health-related quality of life (General Health Survey Short Form-36) at 6 and 26 weeks. Intention-to-treat analysis was used, and between-group differences were estimated using linear mixed models., Results: Baseline mean (SD) HF/NS weekly frequency was 63.15 (49.24), and problem rating was 5.87 (2.28). Group and self-help CBT both significantly reduced HF/NS problem rating at 6 weeks-group CBT versus no treatment control (NTC; adjusted mean difference, 2.12; 95% CI, 1.36-2.88; P < 0.001) and self-help CBT versus NTC (adjusted mean difference, 2.08; 95% CI, 1.29-2.86; P < 0.001)-and at 26 weeks-group CBT versus NTC (adjusted mean difference, 1.33; 95% CI, 0.54-2.13; P = 0.001) and self-help CBT versus NTC (adjusted mean difference, 1.19; 95% CI, 0.36-2.02; P = 0.005). Group and self-help CBT significantly reduced night sweat frequency at 6 and 26 weeks. There were improvements in mood and quality of life at 6 weeks and improved emotional and physical functioning for group CBT at 26 weeks., Conclusions: These results suggest that CBT delivered in group or self-help format is an effective treatment option for women during the menopause transition and postmenopause with problematic HF/NS.

Background: Hot flushes and night sweats (HFNS) affect 65-85% of women after breast cancer treatment; they are distressing, causing sleep problems and decreased quality of life. Hormone replacement therapy is often either undesirable or contraindicated. Safe, effective non-hormonal treatments are needed. We investigated whether cognitive behavioural therapy (CBT) can help breast cancer survivors to effectively manage HFNS., Methods: In this randomised controlled trial, we recruited women from breast clinics in London, UK, who had problematic HFNS (minimum ten problematic episodes a week) after breast-cancer treatment. Participants were randomly allocated to receive either usual care or usual care plus group CBT (1:1). Randomisation was done in blocks of 12-20 participants, stratifying by age (younger than 50 years, 50 years or older), and was done with a computer-generated sequence. The trial statistician and researchers collecting outcome measures were masked to group allocation. Group CBT comprised one 90 min session a week for 6 weeks, and included psycho-education, paced breathing, and cognitive and behavioural strategies to manage HFNS. Assessments were done at baseline, 9 weeks, and 26 weeks after randomisation. The primary outcome was the adjusted mean difference in HFNS problem rating (1-10) between CBT and usual care groups at 9 weeks after randomisation. Analysis of the primary endpoint was done by modified intention to treat. The trial is registered, ISRCTN13771934, and was closed March 15, 2011., Findings: Between May 5, 2009, and Aug 27, 2010, 96 women were randomly allocated to group CBT (n=47) or usual care (n=49). Group CBT significantly reduced HFNS problem rating at 9 weeks after randomisation compared with usual care (mean difference -1·67, 95% CI -2·43 to -0·91; p<0·0001) and improvements were maintained at 26 weeks (mean difference -1·76, -2·54 to -0·99; p<0·0001). We recorded no CBT-related adverse events., Interpretation: Group CBT seems to be a safe and effective treatment for women who have problematic HFNS after breast cancer treatment with additional benefits to mood, sleep, and quality of life. The treatment could be incorporated into breast cancer survivorship programmes and delivered by trained breast cancer nurses., Funding: Cancer Research UK., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Objectives: There is a global trend of increasing numbers of older women in the workforce. However, limited information is available regarding the relationship between the menopause transition and work, especially in developing countries. The objectives of this study were to investigate the relationship between experience of the menopause transition and work and to examine the factors affecting how women cope, including the extent to which women disclosed their menopausal status., Methods: Using a cross-sectional single group design, 131 middle-aged female medical teaching staff working in Zagazig Faculty of Medicine completed questionnaires and semi-structured interviews., Results: Participants, particularly those who were postmenopausal, reported high average scores on depressed mood, memory/concentration, sleep problems, vasomotor symptoms, and sexual behavior subscales of the Women's Health Questionnaire (WHQ). Women reported that poor working environment and work policies and conditions, functioning as sources of work stress, aggravated their menopausal symptoms. Disclosure of their menopausal status was uncommon; limited time and socio-cultural barriers were the most commonly reported reasons for non-disclosure., Conclusion: It could be concluded that the menopause transition is an important occupational health issue especially for women in developing countries. Implementing health promotion programs, improving working environment and work policies, and raising awareness of menopause are recommended to help women to cope with the menopause transition and to maintain well-being and productivity at work., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Objective: There is increasing interest in the development of nonmedical treatments for menopausal hot flushes (HF) and night sweats (NS) and some evidence that cognitive behavioral interventions reduce their impact. However, the behavioral component of HF/NS is underresearched. This article describes the development of the Hot Flush Behavior Scale (HFBehS), a measure of the behavioral strategies that women use in response to HF/NS, and reports on the reliability, validity, and factor structure of the scale., Methods: Behavioral items were generated from the empirical literature and qualitative studies based on in-depth interviews, with the aim of reflecting common behaviors related to HF/NS. A total of 140 women who had HF/NS completed the initial measure. Principal components analyses were applied to the data, with orthogonal rotation, to determine the most coherent and interpretable solution., Results: Exploratory factor analysis culminated in an 11-item measure comprising three dimensions: behavioral avoidance, practical cooling behaviors, and positive behavioral strategies. The Hot Flush Beliefs Scale subscales had reasonable internal consistency, with α values ranging from 0.59 to 0.76. Validity was supported through correlations with measures of HF/NS problem rating and frequency and cognitive measures (HF/NS beliefs)., Conclusions: Preliminary analysis of the HFBehS reveals it to be a psychometrically sound instrument. The HFBehS is grounded in women's experiences and can be used as a measure of behavioral reactions to HF/NS as well as enabling more rigorous evaluation of psychological interventions.

Objectives: Menopause is generally associated with negative social meanings in western cultures. While numerous physical and emotional symptoms have been attributed to it, hot flushes and night sweats (HF/NS) are the main physical change. Recent studies suggest that cognitive factors, particularly beliefs about other people's reactions to their HF/NS, might increase distress, causing embarrassment and behavioural avoidance. Younger men and women tend to have more negative attitudes to menopause but research is needed to establish whether menopausal women's beliefs are grounded in evidence or are overly negative cognitions., Methods: 290 men and women (aged 25-45 years) participated in a questionnaire survey, including both qualitative and quantitative data. Participants answered open-ended questions about their attributions and reactions to a hypothetical scenario of a woman displaying hot flush symptoms and completed a modified version of the Menopause Representations Questionnaire (MRQ) to assess beliefs about menopause., Results: A wide range of attributions and responses were evident. The majority of participants did not attribute redness and sweating to the menopause; similarly mainly neutral and positive responses were expressed. However, this younger sample had significantly more negative beliefs about menopause (MRQ) compared to a sample of menopausal women and women identified more symptoms as being due to the menopause than men. No age differences were evident., Conclusions: These findings suggest that women's beliefs about 'other people's' reactions are unduly negative. This evidence can be used in cognitive behavioural interventions to help women to challenge these beliefs and behaviours that exacerbate distress., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Background: This trial aims to evaluate the effectiveness of a group cognitive behavioural intervention to alleviate menopausal symptoms (hot flushes and night sweats) in women who have had breast cancer treatment. Hot flushes and night sweats are highly prevalent but challenging to treat in this population. Cognitive behaviour therapy has been found to reduce these symptoms in well women and results of an exploratory trial suggest that it might be effective for breast cancer patients. Two hypotheses are tested:Compared to usual care, group cognitive behavioural therapy will:1. Significantly reduce the problem rating and frequency of hot flushes and nights sweats after six weeks of treatment and at six months post-randomisation.2. Improve mood and quality of life after six weeks of treatment and at six months post-randomisation., Methods/design: Ninety-six women who have completed their main treatment for breast cancer and who have been experiencing problematic hot flushes and night sweats for over two months are recruited into the trial from oncology and breast clinics in South East London. They are randomised to either six weekly group cognitive behavioural therapy (Group CBT) sessions or to usual care. Group CBT includes information and discussion about hot flushes and night sweats in the context of breast cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats and maintaining changes.Prior to randomisation women attend a clinical interview, undergo 24-hour sternal skin conductance monitoring, and complete questionnaire measures of hot flushes and night sweats, mood, quality of life, hot flush beliefs and behaviours, optimism and somatic amplification. Post-treatment measures (sternal skin conductance and questionnaires) are collected six to eight weeks later and follow-up measures (questionnaires and a use of medical services measure) at six months post-randomisation., Discussion: MENOS 1 is the first randomised controlled trial of cognitive behavioural therapy for hot flushes and night sweats that measures both self-reported and physiologically indexed symptoms. The results will inform future clinical practice by developing an evidence-based, non-medical treatment, which can be delivered by trained health professionals., Trial Registration: Current Controlled Trials ISRCTN13771934.

Objectives: There is an assumption in menopause research that attitudes to menopause are influenced by a range of cultural, social and psychological variables, which may in turn affect menopausal experience and symptom reporting. However, many studies draw conclusions about this relationship without explicitly examining the empirical evidence. Therefore, the aim of this systematic review is to examine the relationship between attitudes towards menopause and symptom experience using original research studies., Methods: Computerised literature searches were performed with Medline, Web of Knowledge and PubMed databases using 'menopause' and 'attitudes' as the main search terms. Studies were considered if they included a measure of attitude and a measure of menopausal symptoms, if they were original research studies, and if they examined and reported on the relationship between women's attitudes to menopause and their symptom experience., Results: Thirteen studies were included in the review, 1 longitudinal, prospective study and 12 cross-sectional studies. The results of 10 studies supported the view that women with more negative attitudes towards the menopause report more symptoms during this transition and 3 studies found no significant association between these variables., Conclusion: Women with more negative attitudes towards the menopause in general report more symptoms during the menopausal transition. However, use of standardised culturally sensitive attitude, and specific symptom, measures are recommended in future prospective studies.

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.)

Menopausal symptoms are common and problematic for women receiving adjuvant treatment for breast cancer and management presents a challenge. This cross-sectional descriptive study aimed to investigate the experience of menopausal symptoms, current management and treatment preferences of 113 patients with breast cancer. These women (who were prescribed tamoxifen and were on average 3 years post-diagnosis) were recruited from a breast unit database. They completed the Hot Flush and Night Sweats Questionnaire (HFNSQ), the Women's Health Questionnaire (WHQ) and subscales of the EORTC-QLQ-C30 and the BR23, as well as questions about treatments. Forty-four of this sample were also interviewed. The prevalence of hot flushes and night sweats was 80 and 72%, respectively (average 30 per week). Having more problematic hot flushes and night sweats were associated with more anxiety and sleep problems (WHQ), and with poorer emotional and social functioning and worse body image (EORTC-QLQ-C30). The women had used a range of treatments for menopausal symptoms but there was often no evidence for the efficacy for many of these treatments. Strongest preferences were for non-medical treatments, particularly vitamins and herbal remedies and cognitive behavioural therapy (CBT). The evidence for the effectiveness of the former is weak, whereas CBT has been shown to reduce menopausal symptoms, but needs to be evaluated in a population of women who have been treated for breast cancer., (Copyright (c) 2004 John Wiley & Sons, Ltd.)

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. [ABSTRACT FROM AUTHOR]

Abstract 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.

Background: Little is known about transgender women's beliefs and experiences of hormone therapy (HT), as part of their transition process, and particularly as they grow older. Aims: This study aimed to investigate: (i) transgender women's experiences and attitudes to HT, and (ii) expectations of what might occur and/or what occurred after they reached "menopausal age." Methods: Participants were recruited through invitations to an online survey sent to 138 Lesbian, gay, bisexual, transgender plus (LGBT+) support groups across the UK. Sixty-seven transgender women consented and completed the questionnaire; responses were analyzed using a mixed-methods approach. The beliefs about medicines questionnaire (BMQ) was used to assess beliefs about HT, while an inductive thematic qualitative approach was used to explore participants' personal expectations and experiences of HT and their views about the menopause. Results: Participants were aged on average 49 years ranging from 20 to 79 years old. Most (96%) were taking HT. BMQ scores revealed strong beliefs about the necessity of HT and some concerns. Positive views about HT were expressed, with themes including treatment importance, personal and mental health benefits, but concerns about long-term effects, side effects, and maintaining access to the treatment were also mentioned. Views about menopause included uncertainty and questioning of its relevance; some mentioned changes to HT dosage, but most expected to use HT indefinitely. Discussion: This study provides exploratory qualitative and quantitative information about transgender women's views about HT and menopause. Practical implications include improving access to HT and provision of evidence-based information about long-term use. [ABSTRACT FROM AUTHOR]

• Globally, there were 314,974 communications about menopause on the social media platform Twitter between 2014 and 2022, with an annual average of approximately 35,000. • The US and UK were frequent users of Twitter to message about menopause. • Increased messaging about menopause on Twitter in the UK and US was apparent in 2018 and 2019, which may reflect social trends to increase awareness of menopause in these countries. 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. [ABSTRACT FROM AUTHOR]

Introduction: Menopausal problems are among the most prevalent and distressing problems following breast cancer treatment, with 70% women experiencing hot flushes and night sweats (HFNS). A working party was set up to support the development of new research into the management of these problems.Methods: We conducted surveys to explore the need as perceived by women with breast cancer and establish current UK management practices. A patient survey was conducted through a charity, Breast Cancer Care, and a health professional survey via the UK Breast Intergroup. The HFNS Problem Rating Scale was used, as well as specific questions addressing the aims of the study.Results: Six hundred and sixty-five patients responded and 185 health professionals. Twenty-eight percent women had considered stopping adjuvant endocrine treatment because of HFNS, yet 34% had never been asked about HFNS by any health professional. The most commonly offered interventions were SSRIs, such as venlafaxine, yet only 25% patients had been offered these drugs. Cognitive behavioural therapy was rarely suggested (2%) despite good evidence.Discussion: This study shows a lack of coherence in the management of HFNS in breast cancer survivors, which may lead to reduced adherence to adjuvant therapy. There is an urgent need to develop guidelines to support management of HFNS after breast cancer. [ABSTRACT FROM AUTHOR]

Background: Menopausal symptoms are common and may be particularly severe in younger women who undergo treatment-induced menopause. Medications to reduce menopausal symptoms are either contra-indicated or have bothersome side effects. Previous studies have demonstrated that face-to-face cognitive behavioral therapy (CBT) is effective in alleviating menopausal symptoms in women with breast cancer. However, compliance with face-to-face CBT programs can be problematic. A promising approach is to use the Internet to make this form of CBT more accessible and feasible for patients. This study is evaluating the efficacy and cost-effectiveness of an Internet-based CBT program, with or without therapist guidance, in alleviating or reducing the severity of menopausal symptoms. Methods/design: In a multicenter, randomized controlled trial we are evaluating the efficacy of two Internet-based CBT programs in alleviating or reducing the impact of menopausal symptoms, and particularly hot flushes and night sweats, in breast cancer survivors who have experienced a treatment-induced menopause. Secondary outcomes include sexual functioning, sleep quality, hot flush frequency, psychological distress, health-related quality of life and cost-effectiveness. We will recruit 248 women who will be randomized to either a therapist guided or a self-management version of the 6-week Internet-based CBT program, or to a usual care, waiting list control group. Self-administered questionnaires are completed at baseline (T0), and at 10 weeks (T1) and 24 weeks (T2) postrandomization. Discussion: Internet-based CBT is a potentially useful treatment for reducing menopausal symptoms in breast cancer survivors. This study will provide evidence on the efficacy and cost-effectiveness of such an Internet-based CBT program, with or without therapist support. If demonstrated to be efficacious and cost-effective, the availability of such structured supportive intervention programs will be a welcome addition to standard medical treatment offered to cancer patients with treatment-induced menopause. [ABSTRACT FROM AUTHOR]

Background: Hot flushes and night sweats (HFNS) - the main symptoms of the menopause transition - can reduce quality of life and are particularly difficult to manage at work. A cognitive behaviour therapy (CBT) intervention has been developed specifically for HFNS that is theoretically based and shown to reduce significantly the impact of HFNS in several randomised controlled trials (RCTs). Self-help CBT has been found to be as effective as group CBT for these symptoms, but these interventions are not widely available in the workplace. This paper describes the protocol of an RCT aiming to assess the efficacy of CBT for menopausal symptoms implemented in the workplace, with a nested qualitative study to examine acceptability and feasibility.Methods/design: One hundred menopausal working women, aged 45-60 years, experiencing bothersome HFNS for two months will be recruited from several (2-10) large organisations into a multicentre randomised controlled trial. Women will be randomly assigned to either treatment (a self-help CBT intervention lasting 4 weeks) or to a no treatment-wait control condition (NTWC), following a screening interview, consent, and completion of a baseline questionnaire. All participants will complete follow-up questionnaires at 6 weeks and 20 weeks post-randomisation. The primary outcome is the rating of HFNS; secondary measures include HFNS frequency, mood, quality of life, attitudes to menopause, HFNS beliefs and behaviours, work absence and presenteeism, job satisfaction, job stress, job performance, disclosure to managers and turnover intention. Adherence, acceptability and feasibility will be assessed at 20 weeks post-randomisation in questionnaires and qualitative interviews. Upon trial completion, the control group will also be offered the intervention.Discussion: This is the first randomised controlled trial of a self-management intervention tailored for working women who have troublesome menopausal symptoms.Trial Registration: Clin.Gov NCT02623374. [ABSTRACT FROM AUTHOR]

Abstract: 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 &y& Elsevier]

Abstract: Objectives: Menopausal symptoms – hot flushes and night sweats (HF/NS) – are particularly troublesome for women who have undergone breast cancer treatment. Non-medical treatments, such as cognitive behaviour therapy, are being developed but there is a lack of information about cognitive and behavioural reactions to HF/NS in breast cancer patients. Methods: Thirty-five women who had completed active breast cancer treatment with at least 10 HF/NS per week completed questionnaires assessing HF/NS, mood and beliefs, and took part in interviews to elicit cognitive and behavioural reactions and a thematic content analysis used to analyse the data. Results: The mean weekly frequency of HF/NS was 76 (SD=46) (57 HF and 19 NS). Smokers reported significantly more night sweats, but BMI and mood were not associated with HF/NS frequency. Cognitive and behavioural responses were varied but broadly similar to those of well women. The main cognitive themes were: embarrassment/social anxiety, loss of control, beliefs about NS, sleep and tiredness, and the main behaviours were: carry on and ignore them, cool down, avoidance, communication with others. Conclusions: The results are discussed within a cognitive behavioural framework and might inform the development of psychological interventions for these treatment related symptoms. [Copyright &y& Elsevier]