Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.

OBJECTIVE: The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects. METHODS: We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome. RESULTS: A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice. CONCLUSIONS: Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.

Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause) consortium.

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.

Menopause hormone therapy, migraines, and thromboembolism.

Migraine, a common form of headache, is a highly prevalent and disabling condition with a predilection for females. Migraines are neurovascular diseases. The two main types of migraines are migraines with and without aura, and several subtypes exist. There is a strong link between sex steroids and migraines. In women, migraine remissions are associated with stable and critical oestrogen levels. The literature reveals an association between migraine with aura and stroke, with a higher incidence in the young compared with that in the old. The absolute risk of stroke is low; tobacco use and a high dose of oral oestrogens may increase the risk. Early diagnosis, follow-up, and nonhormonal symptomatic and preventive treatments address the neglected area of migraines. Judicious use of hormones throughout the lifespan as needed would improve the quality of life.

Cardiovascular and Osteoporosis Protection at Menopause with Lycopene: A Placebo-Controlled Double-Blind Randomized Clinical Trial.

Objective: The effect of lycopene (LycoRed) supplementation was evaluated in healthy postmenopausal women by biochemical markers for cardiovascular protection and osteoporosis protection. Study Settings and Design: This was a multi-centric placebo-controlled double-blind randomized clinical trial that screened 198 postmenopausal women at 21 centers across 12 cities in India. Levels of lycopene, lipid profile, high-risk C-reactive protein, and bone turnover markers: amino-terminal propeptide of Type I collagen (P1NP) and C-terminal telopeptide of Type I collagen (ß-CTx) were measured at baseline and 6 months postsupplementation with LycoRed or placebo. Interventions: The study was completed with 57 of the 100 women on LycoRed 8 mg (antioxidant potency is equivalent to 24 mg of lycopene) and 43 placebos for 6 months by randomization. Main Outcome Measures: Rise in serum lycopene and effect of serum lycopene on surrogate markers of cardiovascular health and bone health. Results: LycoRed supplementation increases lycopene levels and P1NP and nonsignificant fall in ß-CTx levels in healthy postmenopausal women. Conclusions: Lycopene supplementation in Indian menopausal women may confer protection from osteoporosis as shown by the directional change in the surrogate biochemical markers. This study can form a basis for larger studies with different doses to understand the effect of lycopene to prevent and act as adjuvant treatment on clinical endpoints for cardiovascular disease (CVD) and bone health.

A core outcome set for genitourinary symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.

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.

Video Summary:http://links.lww.com/MENO/A765 .

A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.

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.

Video Summary:http://links.lww.com/MENO/A763 .

Effective risk assessment tools for osteoporosis in the Indian menopausal female.

OBJECTIVES: This study was designed to assess the effectiveness of self-administered osteoporosis risk score sheet, body mass index (BMI), and bone mineral density (BMD) (ultrasound) in screening females with low bone mass, and how the results of the tools correlate with each other. MATERIALS AND METHODS: The study was conducted on 536 postmenopausal women, who attended public awareness camps on Midlife Women Health held at the Menopause Research Unit, MGMCH, Sitapura, Jaipur. At these camps, in addition to several informational sessions on issues related to menopause, ultrasonic measurement of BMD was conducted on each participant. A broad questionnaire to identify midlife health problems was developed, and osteoporosis specific score sheet was designed to be self-administered. Patients were required to complete the osteoporosis specific risk score sheet and women health questionnaire (WHQ). BMI was determined. Statistical analysis was carried out to find the correlation between various variables. Sensitivity and specificity of the each risk score ascertained and cutoff risk score for identifying osteopenia was derived by comparing area under curve of each risk score on drawing receiver operational curve (ROC). RESULTS: Sensitivity of risk score system was calculated to be 78.33% with 95% confidence interval being 73.24-82.86% and specificity was 27.12% with 95% confidence interval being 21.56-33.27%, keeping the cutoff point at nine. There was statistically significant inverse relationship between risk score and BMD values with Pearson correlation coefficient of (-) 0.22 and positive relationship between BMD and BMI with correlation coefficient of 0.192. CONCLUSION: By noting down the risk factors and BMI, we can screen out the women who require further evaluation and management, thus, it is an effective tool, particularly in developing countries like India, where most of the patients cannot afford expensive DEXA scans, although considered as the gold standard for BMD assessment. With the help of such scoring systems, health resources can be judiciously utilized.

Attitudes and practices of gynecologists in Jaipur toward management of menopause.

BACKGROUND: In earlier days, hormone replacement therapy (HRT) was recommended for menopause symptoms and also gained much popularity. However, the Women's Health Initiative (WHI) studies suggested an increased risk of cardiovascular and Alzheimer's disease. These findings led to a dramatic decrease in hormone therapy (HT) prescriptions all over the world. However, the WHI conclusions remain debatable especially because of contradictory results from antecedent studies. Inspite of these controversies, post-WHI, most gynecologists refrain from prescribing MHT (menopausal hormone replacement therapy, MHT). Furthermore, many Indian gynecologists prefer to prescribe alternative treatments that would help alleviate symptoms and thus avoid HRT. We decided to carry out a survey and document the current opinions regarding indications of HRT and alternative therapies and prescribing practices of Jaipur-based gynecologists. OBJECTIVE: This study was designed to find out the current attitudes and practices of gynecologists (Jaipur) towards management of menopause. MATERIALS AND METHODS: A questionnaire concerning attitudes, management strategies, and use of HT was mailed out to gynecologists, and they are asked to complete the questionnaire. Data were analyzed using the total number of respondents (n = 321). The results were analyzed using a simple percentage method as this was most suitable for this kind of studies. RESULTS: From the results, 69.04% gynecologists were currently prescribing MHT. Hot flashes were the most common indication for MHT prescriptions and 78.57% were familiar with controversies surrounding WHI study. Also, 61.9% would consider using MHT for themselves. Alternative therapy was adopted by 83.48% in their prescribing practice. The reason cited by 71% for preferring alternative therapies was that it was safer and less controversial. CONCLUSIONS: The prescribing practices of Jaipur gynecologists in lieu of ongoing controversies surrounding HT have shifted and now also support alternative therapies for menopause management. In this era of phasic prescriptions, for immediate relief of hot flashes and mood swings, MHT was favored. However, for long-term management of women with poor compliance, alternative therapies were considered a safer option.