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.

A qualitative study of work and early menopause: 'On-the job' experiences and career trajectories.

OBJECTIVES: Early menopause or premature ovarian insufficiency (POI), menopause occurring before age 45 and 40 years respectively, occur at the age when most women are establishing or consolidating their careers. Studies of older postmenopausal women indicate an adverse bidirectional relationship between menopause and work. However, data are lacking regarding the work experiences of women with early menopause or POI. We explored the experiences of women with early menopause or POI in relation to work. STUDY DESIGN: Using maximum variation sampling, 30 women (median age 44 years and 38 years at menopause diagnosis) of diverse backgrounds and menopause causes (16/30 iatrogenic) participated in qualitative interviews to explore experiences of early menopause/POI in the context of their overall lives, work and career. Dual thematic (themes identified across interviews) and thematic narrative (themes identified within individual interviews) analysis was done using NVivo 12 software. MAIN OUTCOME MEASURES: Themes related to work experiences and influencing factors. RESULTS: Two major themes were identified: 'on-the-job' experiences (work performance, bodily presentation and disclosure) and career trajectories (intact and altered). Factors impacting the interaction between work and early menopause/POI included: career (type of work, environment, working conditions), personal (age, socio-economic background, family arrangements, migration history) and menopause experience (spontaneous versus iatrogenic, treatment complexity). CONCLUSIONS: Early menopause/POI has multiple impacts on women's work experiences and career trajectories. As with older postmenopausal women, career and personal factors influence younger women's work experience. However, this research highlights differences associated with menopause occurring at an earlier, often unexpected age compared with menopause at the usual age.

Femora of women with premature ovarian insufficiency exhibit reduced strength and misalignment with the transmitted vertical forces from the upper body.

BACKGROUND: Women with premature ovarian insufficiency (POI) lack oestrogen, which is a key determinant of bone growth, epiphyseal closure, and bone tissue organisation. Although dual-energy X-ray absorptiometry (DXA)-derived areal bone mineral density (BMD) remains the gold standard for fracture risk evaluation, it does not fully characterise the skeletal abnormalities present in these women. Hence, we aimed to assess hip/femur anatomy, strength, and geometry and femoral alignment using advanced hip analysis (AHA). METHODS: We conducted a cross-sectional, case-control study including 89 women with spontaneous normal karyotype POI (s-POI) or iatrogenic POI (i-POI), aged 20-50 years compared with 89 age- and body mass index (BMI)-matched population-based female controls. Hip anatomy, strength, geometrical parameters, and femur alignment were measured using hip DXA images and Lunar AHA software. Femoral orientation angle (FOA) was quantified as the overall orientation of the femur with respect to the axis of the forces transmitted from the upper body. RESULTS: The median age of POI diagnosis was 35 (18-40) years; the mean POI duration at the time of DXA was 2.07 (range 0-13) years, and 84% of POI women received oestrogen therapy. Areal BMD at all sites was significantly lower in the POI group (all P < .05). Indices of compressive and bending strength were lower in women with POI compared with controls, specifically the cross-sectional area (CSA, mm2) and section modulus (SM, mm3) (139.30 ± 29.08 vs 157.29 ± 22.26, P < .001 and 665.21 ± 129.54 vs 575.53 ± 150.88, P < .001, respectively). The FOA was smaller (124.99 ± 3.18) in women with POI as compared with controls (128.04 ± 3.80; P < .001) at baseline and after adjusting for height and femoral neck BMD. CONCLUSION: Alongside lower BMD at multiple sites, the femora of women with POI demonstrate reduced strength and a misalignment with forces transmitted from the upper body. Further research is needed to establish the role of these newly identified features and their role in fracture risk prediction in this population.

Bone health in rural Australia: a mixed methods study of consumer needs.

This mixed methods study explores osteoporosis among adults living in a regional area of Victoria, Australia. Three major themes emerged from interviews, which reflected the findings of surveys, concerns regarding the adequacy of care in rural areas, a desire for tailored, local care, and a desire for hybrid telemedicine or in-person services. PURPOSE: Osteoporosis or osteopenia affects over half of adults aged over 50 years. People living outside major cities in Australia have higher hip fracture rates than people living in cities, along with reduced access to bone densitometry and osteoporosis specialists. This study explores osteoporosis risk factors, knowledge, experiences of and preferences for care in people living in a regional area, to inform development of osteoporosis care programs. METHODS: Adults living in a large non-metropolitan region of Australia were invited to participate in a mixed methods study: a survey (phase 1) followed by semi-structured interviews (phase 2) with triangulation of results. Data collected included osteoporosis diagnosis, risk factors, management, knowledge, preferences for care and experience using telemedicine. Surveys were analysed quantitatively, with linear and logistic regression used to assess factors related to osteoporosis knowledge or satisfaction with telemedicine. Interview transcripts were analysed using thematic analysis by two researchers, with in-depth discussion to identify themes. RESULTS: Sixty-two participants completed the survey, and 15 completed interviews. The mean (SD) age of survey participants was 62.2 (14.1) years, 57% had a screening test for osteoporosis, and 12 (19%) had a diagnosis of osteoporosis. The mean osteoporosis knowledge score was 8.4 / 19 and did not differ with age, education, or history of osteoporosis. The majority wanted access to more information about osteoporosis but preferred method differed, and the majority preferred in-person medical consultations to telemedicine. Interview participants were aged between 57 and 87 years, and included 8 with osteoporosis or osteopenia. Three major themes emerged: concerns regarding the adequacy of care in rural areas, a desire for tailored local car and a desire for hybrid telemedicine or in-person services. CONCLUSION: Gaps exist in rural osteoporosis care, including knowledge, screening and management. People have differing experiences of care, access to services and preferences for care. High-quality care, tailored to their needs, was preferred. Improving osteoporosis services for regional Australia will require a flexible, multi-faceted approach, addressing needs of the local community and providers.

My 28 Days - a global digital women's health initiative for evaluation and management of secondary amenorrhea: case report and literature review.

There is a need to close the gap between knowledge and action in health care. Effective care requires a convenient and reliable distribution process. As global internet and mobile communication increase capacity, innovative approaches to digital health education platforms and care delivery are feasible. We report the case of a young African woman who developed acute secondary amenorrhea at age 18. Subsequently, she experienced a 10-year delay in the diagnosis of the underlying cause. A global digital medical hub focused on women's health and secondary amenorrhea could reduce the chance of such mismanagement. Such a hub would establish more efficient information integration and exchange processes to better serve patients, family caregivers, health care providers, and investigators. Here, we show proof of concept for a global digital medical hub for women's health. First, we describe the physiological control systems that govern the normal menstrual cycle, and review the pathophysiology and management of secondary amenorrhea. The symptom may lead to broad and profound health implications for the patient and extended family members. In specific situations, there may be significant morbidity related to estradiol deficiency: (1) reduced bone mineral density, 2) cardiovascular disease, and 3) cognitive decline. Using primary ovarian insufficiency (POI) as the paradigm condition, the Mary Elizabeth Conover Foundation has been able to address the specific global educational needs of these women. The Foundation did this by creating a professionally managed Facebook group specifically for these women. POI most commonly presents with secondary amenorrhea. Here we demonstrate the feasibility of conducting a natural history study on secondary amenorrhea with international reach to be coordinated by a global digital medical hub. Such an approach takes full advantage of internet and mobile device communication systems. We refer to this global digital women's health initiative as My 28 Days®.

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

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

Premature ovarian insufficiency and infertility.

BACKGROUND: Premature ovarian insufficiency (POI) is the loss of ovarian function before the age of 40 years and can be spontaneous or iatrogenic. It is an important cause of infertility, and the diagnosis should be considered in any woman presenting with oligo/amenorrhoea, even in the absence of menopausal symptoms suchas hot flushes. OBJECTIVE: The aim of this article is to provide an overview of the diagnosis of POI and its management with respect to infertility. DISCUSSION: Diagnostic criteria for POI are follicle-stimulating hormone levels >25 IU/L on two occasions at least one month apart following 4-6 months of oligo/amenorrhoea, with exclusion of secondary causes of amenorrhoea. Approximately 5% of women will have a spontaneous pregnancy after a POI diagnosis; however, most women with POI will require a donor oocyte/embryo for pregnancy. Some women may elect to adopt or live childfree. Fertility preservation should be considered for those at risk of POI.

Reproductive health in Turner syndrome: A narrative review.

Turner syndrome (TS), a common chromosomal abnormality affecting females, is associated with partial or complete loss of the second sex chromosome. Although the classic karyotype is 45, X, the detection of mosaic TS is increasing. TS is a multi-system disorder with significant endocrine, cardiovascular and reproductive impacts. Accelerated ovarian follicular loss leads to primary amenorrhoea or premature ovarian insufficiency and infertility. Early diagnosis and counselling regarding hormone replacement therapy and future reproductive capacity, including fertility preservation, are essential to improve reproductive outcomes. Pubertal induction or estrogen replacement is usually required to optimise long-term health outcomes; however, initiation may be delayed due to delayed diagnosis. Spontaneous pregnancy occurs in a small number of women; however, many require donor oocytes and assisted reproductive technology to achieve a pregnancy. Pregnancy is a high risk especially when associated with congenital heart disease. Prepregnancy counselling by the multidisciplinary team (MDT) to identify contraindications and optimise pre-existing health issues is essential. Pregnancy management should be led by a maternal-fetal medicine unit with input from the MDT. This review examines reproductive health outcomes in women with TS and how best to manage them to reduce health risks and improve maternal and neonatal outcomes.

Occurrence and impact of pelvic floor dysfunction in women with and without breast cancer: a cross-sectional study.

BACKGROUND: One of the sequalae of breast cancer treatments may be pelvic floor (PF) dysfunction such as urinary incontinence (UI), faecal incontinence (FI), and pelvic organ prolapse (POP). OBJECTIVE: The aim of this study was to compare the occurrence and related distress and impact of PF dysfunction between women with and without breast cancer. METHODS: Women with and without breast cancer participated in this cross-sectional study. The Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire were used to quantify the prevalence and related distress, and impact of PF dysfunction. Factors associated with PF outcomes were examined using logistic and linear regressions while controlling for known risk factors for PF dysfunction (age, body mass index, and parity). RESULTS: 120 women with breast cancer, and 170 women without breast cancer responded. The occurrence of any type of UI was higher in women with breast cancer than women without breast cancer (percentage difference=17%; 95% CI: 7, 29). Women with breast cancer experienced higher impact of urinary symptoms (mean difference=18.2; 95% CI: 8.9, 27.7) compared to those without. Multivariable analysis indicated that having breast cancer (ß 0.33; 95%CI: 0.08, 0.51) was the strongest predictor of greater impact of urinary symptoms. CONCLUSION: Women with breast cancer reported a higher occurrence and impact of urinary symptoms than women without breast cancer. While further studies are required to confirm our findings, routine screening and offering treatment for urinary symptoms may be indicated for women with breast cancer.

Associations of Sex, Age, and Cardiometabolic Risk Profiles With Brain Structure and Cognition: A UK Biobank Latent Class Analysis.

BACKGROUND AND OBJECTIVES: It is unknown whether there are sex-related profiles of cardiometabolic health that contribute differently to age-related changes in brain health during midlife. We studied how latent classes of middle-aged individuals clustering by age, sex, menopause, and cardiometabolic health were associated with brain structure and cognitive performance. METHODS: Health, brain, and abdominal MRI data from the UK Biobank cohort (men and women aged >40 years in the United Kingdom) were used. We applied latent class analysis to identify groups of individuals based on age, sex, menopausal status, and cardiometabolic health. We examined associations of class membership with brain volumes (total brain volume [TBV], gray matter volume [GMV], white matter volume [WMV], hippocampal volume, and white matter hyperintensity volume) and cognitive performance. RESULTS: Data were available for 36,420 individuals (mean age 64.9 years, 48.5% women). Eight latent classes differing in age, sex, and cardiometabolic risk were identified. Class 1 (reference class) included individuals with the lowest probability of older age and cardiometabolic risk, and the healthiest levels of brain volumes and cognition. In those aged >60 years, but not in those aged 50-60 years, the negative associations of age with TBV, GMV, and WMV were greater in the class comprising healthier older women than classes comprising older men of varying cardiometabolic and vascular health. There were no age-class interactions for cognitive test performance. DISCUSSION: Latent class analysis detected groups of middle-aged individuals clustering by cardiometabolic health. The relationship of age with brain volumes varies by sex, menopausal status, and cardiometabolic health profile.

Abnormal Trabecular Bone Score, Lower Bone Mineral Density and Lean Mass in Young Women With Premature Ovarian Insufficiency Are Prevented by Oestrogen Replacement.

Background: Low bone density (BMD) and fractures commonly affect women with premature ovarian insufficiency (POI). However, bone microarchitecture and body composition data are lacking. Objective: To assess and characterise musculoskeletal phenotype and effects of oestrogen replacement therapy (ERT) in women with POI. Method: Cross-sectional and longitudinal studies of 60 normal karyotype women with POI, aged 20-40 years, from 2005-2018. Dual x-ray absorptiometry (DXA)-derived spinal (LS) and femoral neck (FN) BMD, trabecular bone score (TBS), appendicular lean mass (ALM), total fat mass (TFM), and fracture prevalence were compared with 60 age-, and BMI-matched population-based controls. Longitudinal changes in bone and body composition variables and ERT effects were analysed using linear mixed models over a median duration of 6 years. Results: Women with POI were subdivided into spontaneous (s)-POI (n=25) and iatrogenic (i)-POI (n=35). Median(range) age of POI diagnosis was 34 (10-40) years with baseline DXA performed at median 1(0-13) year post-diagnosis. ERT was used by 82% women (similar for both POI groups). FN-BMD were lowest in s-POI (p<0.002). Low TBS was more common in s-POI [(44%), p=0.03], versus other groups. LS-BMD and ALM were lower in both s-POI and i-POI groups than controls (p<0.05). Fracture prevalence was not significantly different: 20% (s-POI), 17% (i-POI), and 8% (controls) (p=0.26). Longitudinal analysis of 23 POI women showed regular ERT was associated with ALM increment of 127.05 g/year (p<0.001) and protected against bone loss. However, ERT interruption was associated with annual reductions in FN BMD and TBS of 0.020g/cm2 and 0.0070 (p<0.05), respectively. Conclusion: Deficits in BMD, trabecular microarchitecture, and lean mass were present in women with POI. However, regular ERT protected against declines in bone variables, with an increase in ALM. Assessment of skeletal and muscle health, and advocating ERT adherence, is essential in POI to optimise musculoskeletal outcomes.

Positive impact of a co-designed digital resource for women with early menopause.

OBJECTIVE: To evaluate a co-designed early menopause digital resource, including audio/video clips, question prompt list, and information links. METHODS: Pre/post-test study. Women with early menopause, defined as menopause before age 45 years, were recruited from the community. Following online informed consent, participants were emailed links to the digital resource and online surveys to complete before (baseline) and, immediately and 1 month after viewing the resource. Main outcome measures: Health-related empowerment (Health Education Impact Questionnaire), illness perception (Brief Illness Perception Questionnaire), menopause symptoms (Greene Climacteric Scale), risk perception, and knowledge change. RESULTS: One hundred fifty women participated. Compared to baseline, at 1-month health-related empowerment, 'health directed behavior' scores increased (mean change: +0.13; 95% CI: 0.01-0.24; and P = 0.03), 'emotional distress' decreased (mean change: -0.15; 95% CI: -0.25 to -0.05; and P = 0.003) and physical and emotional menopause symptom scores decreased (P = 0.001 and P  = 0.02, respectively). Illness perception scores increased at both immediate and 1-month follow-up versus baseline for 'personal control' (P < 0.001 and P  = 0.02) and 'coherence' (P = 0.003 and P  < 0.001). After viewing the digital resource, more women perceived that hormone therapy decreases heart disease risk, reduces hot flashes, and prevents fractures versus baseline (all P  < 0.05). More women correctly answered questions regarding early menopause prevalence (60% vs 35%), cause (46% vs 33%), risk (76% vs 55%), effect of phytoestrogens (60% vs 27%), and osteoporosis prevention (64% vs 44%) at immediate or 1-month follow-up versus baseline (all P  < 0.05). CONCLUSIONS: A co-designed early menopause digital resource may improve women's health-related empowerment, illness perception, menopause symptoms, risk perception, and knowledge.

Video Summary:http://links.lww.com/MENO/A923 .

Secondary Osteoporosis.

Osteoporosis is a global public health problem, with fractures contributing to significant morbidity and mortality. Although postmenopausal osteoporosis is most common, up to 30% of postmenopausal women, > 50% of premenopausal women, and between 50% and 80% of men have secondary osteoporosis. Exclusion of secondary causes is important, as treatment of such patients often commences by treating the underlying condition. These are varied but often neglected, ranging from endocrine to chronic inflammatory and genetic conditions. General screening is recommended for all patients with osteoporosis, with advanced investigations reserved for premenopausal women and men aged < 50 years, for older patients in whom classical risk factors for osteoporosis are absent, and for all patients with the lowest bone mass (Z-score ≤ -2). The response of secondary osteoporosis to conventional anti-osteoporosis therapy may be inadequate if the underlying condition is unrecognized and untreated. Bone densitometry, using dual-energy x-ray absorptiometry, may underestimate fracture risk in some chronic diseases, including glucocorticoid-induced osteoporosis, type 2 diabetes, and obesity, and may overestimate fracture risk in others (eg, Turner syndrome). FRAX and trabecular bone score may provide additional information regarding fracture risk in secondary osteoporosis, but their use is limited to adults aged ≥ 40 years and ≥ 50 years, respectively. In addition, FRAX requires adjustment in some chronic conditions, such as glucocorticoid use, type 2 diabetes, and HIV. In most conditions, evidence for antiresorptive or anabolic therapy is limited to increases in bone mass. Current osteoporosis management guidelines also neglect secondary osteoporosis and these existing evidence gaps are discussed.

Models of care for osteoporosis: A systematic scoping review of efficacy and implementation characteristics.

BACKGROUND: Osteoporosis affects over half of adults over 50 years worldwide. With an ageing population, osteoporosis, fractures and their associated costs are increasing. Unfortunately, despite effective therapies, many with osteoporosis remain undiagnosed and untreated. Models of care (MoC) to improve outcomes include fracture liaison services, screening, education, and exercise programs, however efficacy for these is mixed. The aim of this study is to summarise MoC in osteoporosis and describe implementation characteristics and evidence for improving outcomes. METHODS: This systematic scoping review identified articles via Ovid Medline and Embase, published in English between 01/01/2009 and 15/06/2021, describing MoC for adults aged ≥18 years with, or at risk of, osteoporosis and / or health professionals caring for this group. All included at least one of clinical, consumer or clinician outcomes, with fractures and bone mineral density (BMD) change the primary clinical outcomes. Exclusion criteria were studies assessing pharmaceuticals or procedures without other interventions, or insufficient operational details. All study designs were included, with no comparator necessary. Title and abstract were reviewed by two reviewers. Full text review and data extraction was performed by these reviewers for 20% of article and, thereafter by a single author. As the review was predominantly descriptive, no comparator statistics were used. FINDINGS: 314 articles were identified describing 289 MoC with fracture liaison services (n=89) and education programs (n=86) predominating. The population had prior fragility fracture in 77 studies, the median (IQR) patient number was 210 (87, 667) and the median (IQR) follow-up duration for outcome assessment was 12 (6, 12·5) months. Fracture reduction was reported by 65 studies, with 16 (37%) graded as high quality, and 19 / 47 studies with a comparator group found a reduction in fractures. BMD change was reported by 73 studies, with 41 finding improved BMD. Implementation characteristics including reach, fidelity and loss to follow-up were under-reported, and consumer and clinician perspectives rare. INTERPRETATION: This comprehensive review of MoC for osteoporosis demonstrated inconsistent evidence for improving outcomes despite similar types of models. Future studies should include implementation outcomes, consumer and clinician perspectives, and fracture or BMD outcomes with sufficient duration of follow-up. Authors should consider pragmatic trial designs and co-design with clinicians and consumers.

Dual Energy X-ray Absorptiometry Reports Fail to Adhere to International Guidelines.

INTRODUCTION: Bone mineral density, measured by dual X-ray absorptiometry (DXA), is the gold standard for diagnosis of osteoporosis. The utility of DXA relies on the accuracy of scan acquisition, interpretation of data, and the adequacy of reports. The International Society for Clinical Densitometry (ISCD) has published guidelines regarding minimum reporting guidelines. This study assessed whether DXA reports for patients receiving care at an academic teaching hospital adhere to these reporting standards, and determine whether differences exist depending on patient factors and the imaging service. METHODS: Patients aged ≥18 years, receiving care at specialist outpatient clinics between January 1, 2018 and December 31, 2019, with a DXA report available, were eligible for inclusion. DXA reports were manually reviewed for adherence to ISCD guidelines, with each criterion scored as one point, giving a total score of 14 for baseline DXA scans and 18 for repeat DXA scans. The score was then converted to a percentage. RESULTS: Of 459 DXA scans included, 214 were performed internally at our hospital and 245 performed at 23 external imaging services. Mean (SD) patient age was 60 (16.3) years, and 75.8% were female. The overall median (IQR) report score was 57.1% (42.9, 82.4). ISCD criteria with the lowest scores were recommendation and timing of future DXA scans (included in 1.1% of reports) and investigation for secondary causes of osteoporosis (included in 1.2% of reports). Reports performed internally had significantly higher scores than those performed externally, after adjusting for age, sex, indication, and type of scan (incidence rate ratio 1.83, 95% confidence interval 1.77, 1.89). Baseline DXA reports had slightly higher scores than repeat DXA scans, and, among external imaging services, rural services had higher scores than metropolitan services. CONCLUSION: This study, the largest comprehensive evaluation of DXA reports, highlights significant deficiencies and variation in report standards between imaging services. This has potential implications for osteoporosis diagnosis and management.

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 .

Interactions Between Age, Sex, Menopause, and Brain Structure at Midlife: A UK Biobank Study.

OBJECTIVES: Age and female sex are risk factors for dementia, and menopause is associated with cognitive dysfunction. Previous work largely considered the effects of sex and menopause as being independent of age. We studied whether age interacts with sex or menopause in explaining imaging biomarkers of dementia during midlife. METHODS: In this cross-sectional study of UK Biobank participants with brain magnetic resonance imaging (MRI), we explored the interaction of age with sex or menopausal status in explaining total brain volume (TBV), gray matter volume (GMV), white matter volume (WMV), white matter hyperintensity volume (WMHV), regional cortical volume , and subcortical volume. RESULTS: Data were available for 1827 postmenopausal women, 230 pre/perimenopausal women and 2165 men (median age 63.3 years). There was a significant interaction between age and sex (P = .024) for TBV, where the inverse association age with TBV was steeper in women (ß = -5.35 mL/year) than in men (ß = -4.77 mL/year). Similar age-sex interactions were also observed for GMV and WMV. In women, there was a significant interaction between age and menopausal status (P = .007) where the inverse association of age with TBV was steeper in postmenopausal (ß = -5.89 mL/year) than in pre/perimenopausal women (ß = -1.61 mL/year). Similar age-menopause interactions were found in predicting lower GMV and higher WMHV. Differences in the direction of these age-sex and age-menopause interactions were found for regional cortical and subcortical brain volumes. CONCLUSION: Sex and menopause both interact with age during midlife in explaining MRI biomarkers of dementia. Further work is required to understand the mechanisms driving these interactions to develop strategies for delaying dementia.