Pharmacist recommendations for emergency contraception in Belgium: a simulated user study.

BACKGROUND: Emergency contraception reduces the risk of unintended pregnancy, after unprotected sexual intercourse or contraceptive failure. In Belgium, emergency contraception is available without a prescription and pharmacists play therefore a crucial role in dispensing emergency contraception. AIM: This study assesses the dispensing practices of emergency contraception by pharmacists in two regions of Belgium. METHOD AND DESIGN: Simulated patient study, using a predefined scenario, evaluating a request for emergency contraception. The scenario involves a 25-year-old woman not using contraception, who had unprotected sexual intercourse 84 h (3.5 days) ago. Her last menstrual period was 10 days ago. POPULATION: 260 pharmacies were randomly selected. Principal outcome: proportion of pharmacists who deliver the adequate emergency contraception. We considered the following responses as adequate: Prescribing ulipristal acetate or redirecting to another pharmacy, in case of unavailability, or referring for a copper IUD. RESULTS: We analysed the data obtained in 216 pharmacies (216/260 = 83.1%). In 64% of cases, adequate dispensing of emergency contraception (dispensing of ulipristal acetate or referral for intrauterine device insertion) occurred. There was an association between correct dispensing and asking appropriate questions, such as the date of the last menstrual period and the date of the risky sexual intercourse. CONCLUSION: More than one-third of visited pharmacies did not distribute appropriate emergency contraception, underlining the need for improvement. We hypothesise that this may be achieved with appropriate training, use a dispensing checklist.

We assesses the dispensing of emergency contraception by pharmacists using a simulated patient. More than one-third of visited pharmacies did not distribute appropriate emergency contraception, underlining the need for improvement.

The recent natural history of human papillomavirus cervical infection in women living with HIV: A scoping review of meta-analyses and systematic reviews and the construction of a hypothetical model.

BACKGROUND: Women with HIV are more often infected with human papillomavirus (HPV) and are more prone to develop precancerous cervical lesions (squamous intraepithelial lesions, SIL) and invasive cervical cancer (ICC) than HIV-negative women. OBJECTIVE: This scoping-review analyses the impact of HIV on HPV prevalence, incidence and evolution to SIL and ICC. METHODS: We selected all PubMed systematic reviews and meta-analyses published between January 2000 and July 2021 reporting data about HPV, cervical intraepithelial neoplasia (CIN), SIL and ICC prevalence, incidence and evolution in women with HIV. A hypothetical model comparing the history of HPV infection in HIV-negative, combined antiretroviral therapy (cART)-treated and -untreated women with HIV was built. RESULTS: Data from 11 meta-analyses and 10 systematic reviews were selected, which included between 770 and 236 127 women with HIV. Women with HIV have a 3 to 6 times higher risk of being infected by HPV, of progression to high-grade SIL (HSIL) and to ICC. These risks are exacerbated when the CD4 cell counts are low and when they are not using cART, whereas these risks are reduced by 20%-30% when they are optimally treated with cART and have had a suppressed HIV viral load for at least 2 years. In our model, we illustrated that optimal HIV treatment and preventing HIV reduce the number of ICC cases by 2.5 and 6 times, respectively. CONCLUSIONS: Optimal treatment and care of HIV patients are essential to reduce their prevalence of ICC, as are preventive strategies which include HPV vaccination, cervical cancer screening strategies and treatment of HSIL.

Care after premenopausal risk-reducing salpingo-oophorectomy in high-risk women: Scoping review and international consensus recommendations.

Women at high inherited risk of ovarian cancer are offered risk-reducing salpingo-oophorectomy (RRSO) from age 35 to 45 years. Although potentially life-saving, RRSO may induce symptoms that negatively affect quality of life and impair long-term health. Clinical care following RRSO is often suboptimal. This scoping review describes how RRSO affects short- and long-term health and provides evidence-based international consensus recommendations for care from preoperative counselling to long-term disease prevention. This includes the efficacy and safety of hormonal and non-hormonal treatments for vasomotor symptoms, sleep disturbance and sexual dysfunction and effective approaches to prevent bone and cardiovascular disease.

Associated morbidity in screened and diagnosed breast cancer patients: a retrospective study.

INTRODUCTION: Breast cancer (BC) screening has been associated with reduced mortality and morbidity. This study compares tumor characteristics and treatment morbidity in screened versus diagnosed women. MATERIALS AND METHODS: This retrospective study, conducted between 2010 and 2013, included 666 BC screened or diagnosed patients. We compared patients and tumors characteristics and received treatments. We also analyzed the results after excluding patients at risk of BC and conducted a multivariate analysis to assess odds ratios (OR). RESULTS: Screened women had smaller tumors (16,5 vs 22,6 mm, p < 0.001), of lower grade (p < 0.001) with a lower proliferation index (PI) (p < 0.001) than diagnosed women. Screened women were more frequently treated using conservative surgery (82.8% vs 59.7%, p < 0.001), needed less often axillary dissection (15.1% vs 35.4%, p < 0.001) and less often chemotherapy (20.8% vs 48.3% p < 0.001) than diagnosed women. In the multivariate analysis after adjustment for age and BC history, diagnosed women had increased (OR: 4.79, 95% IC: 3.19-7,18) risk to be administered chemotherapy and to undergo axillary dissection (OR: 4.18, 95% IC: 1.56-11.17) than screened women. CONCLUSION: Patients should be informed about the benefits in terms of morbidity that screening confers to them.

Impact of Covid-lockdown on abortion management at a family planning in Brussels.

INTRODUCTION: In response to the Covid-19 lockdown, we developed a new abortion protocol in a family planning in Brussels. This study evaluates the effects of the lockdown on the abortion management and its impact on patients' characteristics. METHODS: A retrospective study compared the characteristics and management of patients who terminated their pregnancies at the same family planning (CHU Saint-Pierre Brussels) between 14 March and 6 May 2020 and during the same time period in 2019. RESULTS: Patients having an abortion in 2020 (n = 87) were in average two years older compared to patients having abortions in 2019 (n = 93) (31 years ± 13 vs 29 years ± 13 p < .011), the number of abortions was similar to those of previous years, and the characteristics of the population were identical. The management of abortions has changed significantly as the patients terminated their pregnancies earlier in 2020 than in 2019 (7 W and 1 day ± 3 days versus 8 W and 5 days ± 3 days p < .01), mostly with medication and at home (61.4% versus 2% p < .001), but with similar effectiveness. CONCLUSION: Due to the lockdown, we have accelerated the time required to obtain an appointment and shortened the delay between the abortion request and the pregnancy termination, permitting an earlier management mainly through the use of medical- and at home abortion. Given the satisfactory results, we consider now to implement this new protocol beyond the lockdown period.

Should the management of high grade cervical squamous intraepithelial lesion (HSIL) be different in HIV-positive women?

BACKGROUND: This study compares the management and outcome of high grade squamous intraepithelial lesions (HSIL) in HIV-positive and -negative women and identifies risk factors for treatment failure. METHODS: This retrospective, controlled study includes 146 HIV-positive women, matched for HSIL, age and year of diagnosis, with 146 HIV-negative women. Differences were analysed using parametric and non-parametric tests and Kaplan-Meier survival curves. A binary logistic regression was used to assess risk factors for treatment failure. RESULTS: Persistence of cervical disease was observed most frequently in HIV-positive women (42 versus 17%) (p < 0.001) and the cone biopsy margins were more often invaded in HIV-positive-women than in HIV-negative ones. (37 versus 16%; p < 0.05). HIV-positive women, with successful cervical treatment had better HIV disease control: with significantly longer periods of undetectable HIV viral loads (VL) (19 versus 5 months; p < 0.001) and higher CD4 counts (491 versus 320 cells/mm3; p < 0.001). HIV-positive women with detectable VL at the time of dysplasia had 3.5 times (95% IC: 1.5-8.3) increased risk of treatment failure. Being treated through ablative therapy was associated with a 7.4, four-fold (95% IC: 3.2-17.3) increased risk of treatment failure compared to conization CONCLUSION: HIV-positive women have a higher risk of treatment failure of HSIL than do HIV-negative women, especially when ablative therapy is used and in women with poor control of their HIV infection. The management and the follow- up of HSIL's guidelines in this high-risk population should be adapted consequently: for HIV-positive women with uncontrolled viral load, excisional treatment should be the preferred therapy, whereas for women with undetectable viral load, CD4 + lymphocytes higher than 500 cells/mm3 and with a desire of pregnancy, ablative therapy may be considered.

Acute fatty liver of pregnancy - A short review.

Acute fatty liver of pregnancy (AFLP) is a rare but dramatic condition associated with a high maternal and fetal morbidity and mortality. We present a short review of AFLP management, illustrated by a case report. We conducted a systematic literature search for 'acute fatty liver of pregnancy', concerning its management. We found initially 11 studies, and three of them met the selection criteria. Prompt diagnosis, maternal stabilisation and rapid delivery are mandatory. This illustrative AFLP case fulfilled nine out of 14 Swansea criteria. Caesarean section is often required (as illustrated in this case), reducing maternal and perinatal mortality rates.

Immunohistochemical Analysis of Somatostatin Receptors in Endometriosis Tissue Samples: A Retrospective Study.

Three types of endometriosis are described: superficial peritoneal endometriosis (SPE), ovarian endometrioma (OMA), and deep infiltrating endometriosis (DIE). The expression of somatostatin receptors (SSTR1, 2, and 5) in human endometrial tissue and its ectopic form has been previously studied and may be different in each type of endometriosis. The aim of this study was to assess the immunohistochemical expression of SSTR1, 2, and 5 in tissue samples of SPE, OMA, and DIE. We performed a retrospective analysis in the pathology department database. Patients aged <50 yr and diagnosed with endometriosis have been identified and sorted into 3 groups according to their endometriosis type: SPE, OMA, and DIE. For each selected patient, formalin-fixed paraffin-embedded blocks were retrieved in order to make new sections to be incubated with polyclonal rabbit antibodies anti-SSTR1, 2, and 5. Receptor status was considered as positive on the sections when >50% of the cells showed immunostaining. Seventy-six patients were included in the analysis. SSTR1 and 5 were expressed in 95.4% and 77.2% of SPE, respectively, in 95.8% and 83.3% of OMA, respectively, and in 100% and 80% of DIE, respectively. There was no significant difference between SPE, OMA, and DIE with regard to the SSTR1 (P=0.5) and SSTR5 (P=0.9) expression. We observed a significant difference between SPE (9.0%), OMA (16.6%), and DIE (63.3%) with regard to SSTR2 expression (P<0.05). The present study identifies 2 different immunohistochemical patterns of endometriosis lesions with regard to their SSTR expression: SSTR1+/SSTR2-/SSTR5+ for SPE and OMA, and SSTR1+/SSTR2+/SSTR5+ for DIE.

Increased live births after day 5 versus day 6 transfers of vitrified-warmed blastocysts.

PURPOSE: An investigation into the clinical implications of delayed blastulation (day 5 versus day 6) was carried out for cryo cycles, as heterogeneous results persist in the current literature. METHODS: We performed a retrospective study comparing clinical pregnancies and live births between 178 blastocysts vitrified and warmed on day 5 versus 149 on day 6. The stage of blastocyst development was taken into account and adjustment for confounding factors was performed. RESULTS: Our results demonstrate a significant difference in clinical pregnancy (43 versus 23% p value < 0.001) and live birth rates (34 versus 16% p value < 0.001) regarding the day of vitrification, in favour of day 5. This difference persisted after adjustment for confounding factors. The adjusted odds ratio for clinical pregnancies and deliveries for the day 5 group compared to that of the day 6 group was 2.83 (95%CI, 1.48 to 5.41) and 2.94 (95%CI, 1.39 to 6.22), respectively. When the stage of development of the blastocyst was taken into consideration, we still observed a significant advantage of day 5 versus day 6 vitrification. CONCLUSIONS: Day of vitrification (day 5 versus day 6) appears to be an independent predictor of clinical outcomes. Stratification of our cohort was carried out according to the developmental stage, and significant differences persisted. Although the transfer of day 6 cryopreserved embryos remains a viable option, giving priority to a day 5 embryo would reduce the time to pregnancy.

Maternal thyroid parameters in pregnant women with different ethnic backgrounds: Do ethnicity-specific reference ranges improve the diagnosis of subclinical hypothyroidism?

OBJECTIVE: Guidelines on the management of thyroid dysfunction during pregnancy have recently been updated and, for the diagnosis of subclinical hypothyroidism (SCH), a thyroid-stimulating hormone (TSH) upper reference limit (cut-off) of 4.0 mIU/L has been proposed when no institutional values are available. It is also suggested that serum TSH and thyroid autoimmunity (TAI) may be different according to the ethnic background of the women. We therefore determined the prevalence of TAI and SCH in pregnant women with different ethnic backgrounds and, to define SCH, we used different first trimester TSH upper reference cut-offs (institutional, ethnicity-specific, 2.5 mIU/L [Endocrine Society] and 4.0 mIU/L [American Thyroid Association]). DESIGN: Cross-sectional data analysis of 1683 pregnant women nested within an ongoing prospective database of pregnant women. METHOD: The study was performed in a single centre in Brussels, Belgium. During the first antenatal visit, thyroid peroxidase antibodies (TPO-abs), TSH and free T4 (FT4) were measured and baseline characteristics recorded. Data from 481 women with sub-Saharan (SaBg; 28.6%), 754 North African (NaBg; 44.8%) and 448 Caucasian (CaBg; 26.6%) backgrounds were analysed. For the calculation of TSH reference ranges, women with TAI, outliers, twin and assisted pregnancies were excluded. RESULTS: The prevalence of TAI was significantly lower in the SaBg group than in NaBg and CaBg groups (3.3% vs 8.6% and 11.1%; P<.001, respectively). Median TSH was significantly lower in SaBg and NaBg groups as compared with the CaBg group (1.3 and 1.4 vs 1.5 mIU/L; P=.006 and .014, respectively). The prevalence of women with SCH was comparable between all groups when 2.5 mIU/L was used as cut-off, but when 4.0 mIU/L or the institutional cut-off (3.74 mIU/L) was used, it was significantly higher in the CaBg group vs the NaBg group (5.4% vs 2.1% and 7.1% vs 3.3%, P=.008 and .013, respectively). The use of ethnicity-specific cut-offs did not change the prevalence of SCH as compared to the use of institutional cut-offs. However, when these cut-offs were used, the prevalence of SCH reduced by >70% (4.5% instead of 16.7%; P<.001) relative to the 2.5 mIU/L cut-off. CONCLUSIONS: Pregnant women with a sub-Saharan African background had a lower prevalence of TAI and TSH levels as compared with women from other backgrounds. The use of ethnicity-specific TSH cut-offs in early pregnancy was not more specific for the diagnosis of SCH as compared to the use of the institutional cut-off.

In vitro fertilization for women infected by hepatitis C virus: a matched case-control study and a systematic literature review.

PURPOSE: The aim of this study was to investigate whether infection of women by the hepatitis C virus (HCV) reduces the chance of conceiving after in vitro fertilization (IVF). METHODS: We performed a retrospective blind matched case-control study where IVF outcomes for the first 37 cycles of HCV sero-positive women were compared to those of 107 cycles of an uninfected control group. Our results were included in a systematic literature review. RESULTS: Out of five eligible studies, ours included, three observed an impact of HCV infection, though at various levels including response to stimulation, fertilization, implantation, and pregnancy rates. Two studies differentiated results for patients with confirmed active viral replication. Matching criteria and populations studied varied between studies. CONCLUSIONS: More and larger studies with well-defined groups are needed to clarify the eventual impact of the HCV on IVF outcomes. Data concerning the infectious status of a patient as well as her health state should be systematically recorded. A multi-disciplinary approach as well as a thorough knowledge of the patient's general health state might prove useful in the management and counseling of these patients in terms of success in conceiving.

In vitro fertilization when men, women, or both partners are positive for HIV: a case-control study.

PURPOSE: The aim of this study was to compare the outcomes of in vitro fertilization (IVF) for couples where one or both partners were positive for the human immunodeficiency virus (HIV) to matched control couples. METHODS: A matched case-control retrospective study was performed. Data for 104 couples where the woman was HIV-positive; for 90 couples where the man was HIV-positive; and for 33 couples where both partners were HIV-positive were prospectively analyzed in comparison to matched controls treated in our center during the same period. The main outcomes were clinical pregnancy and live birth rates. RESULTS: For couples involving an HIV-positive man, clinical outcomes were comparable to controls and resulted in the birth of 18 healthy babies after 90 cycles. When the woman was affected, cycle cancelation, number of retrieved oocytes, and on-going clinical pregnancy rates per transfer were statistically reduced. Implantation rates were comparable to those of non-affected controls. Seven healthy babies for 104 cycles were obtained. For a couple in which both partners were HIV-positive, only one healthy birth occurred after 33 cycles. Pregnancy rates were systematically reduced though not significantly probably due to sample size. CONCLUSIONS: Our data suggest that IVF outcomes were similar to controls when men were HIV-positive and remain acceptable when women were HIV-positive. IVF outcomes were severely reduced in our sero-concordant couples; however, many patients had severe HIV disease previously, and therefore, these results should be reassessed in patients treated early in their disease.

The use of selective progestin receptor modulators (SPRMs) and more specifically ulipristal acetate in the practice of gynaecology.

This review discusses the development of selective progestin receptor modulators (SPRMs) for use in women's health and specifically the use of ulipristal acetate (UPA) as emergency contraception (EC) and as a treatment for symptomatic fibroids in women who want to preserve their fertility or avoid a hysterectomy. As an EC, UPA 30 mg should be recommended for women, within 102 h of unprotected intercourse. As a treatment of fibroids, UPA (5 mg daily dose) should be administered for periods of three months as a pre-surgical strategy, reducing bleeding and fibroid size and facilitating surgery. A proportion of these patients may even avoid surgery. Future developments will demonstrate whether UPA can be used for other indications such as endometriosis and breast cancer prevention or treatment.

Effects of Dairy Products Consumption on Health: Benefits and Beliefs--A Commentary from the Belgian Bone Club and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases.

Dairy products provide a package of essential nutrients that is difficult to obtain in low-dairy or dairy-free diets, and for many people it is not possible to achieve recommended daily calcium intakes with a dairy-free diet. Despite the established benefits for bone health, some people avoid dairy in their diet due to beliefs that dairy may be detrimental to health, especially in those with weight management issues, lactose intolerance, osteoarthritis, rheumatoid arthritis, or trying to avoid cardiovascular disease. This review provides information for health professionals to enable them to help their patients make informed decisions about consuming dairy products as part of a balanced diet. There may be a weak association between dairy consumption and a possible small weight reduction, with decreases in fat mass and waist circumference and increases in lean body mass. Lactose intolerant individuals may not need to completely eliminate dairy products from their diet, as both yogurt and hard cheese are well tolerated. Among people with arthritis, there is no evidence for a benefit to avoid dairy consumption. Dairy products do not increase the risk of cardiovascular disease, particularly if low fat. Intake of up to three servings of dairy products per day appears to be safe and may confer a favourable benefit with regard to bone health.

Oocytes affected by smooth endoplasmic reticulum aggregates: to discard or not to discard?

PURPOSE: Oocytes containing smooth endoplasmic reticulum aggregates (SERa) have been associated with reduced fertilization and clinical pregnancy rates as well as compromised neonatal outcomes. It was therefore recommended by an Alpha-ESHRE Consensus to discard oocytes presenting this dysmorphism. The data in the literature are nevertheless conflicting and healthy babies have recently been obtained from affected oocytes. The objectives of this study were to compare clinical outcomes between ICSI cycles with and without oocytes affected by smooth endoplasmic reticulum aggregates and to confirm whether affected oocytes can produce healthy babies. METHODS: A prospective observational study was performed comparing 714 SERa- ICSI cycles to 112 SERa+ cycles. Among the SERa+ cycles, 518 SERa- oocytes and 213 SERa+ oocytes were analyzed. Fertilization, embryo quality, and pregnancy rates as well as neonatal outcomes were compared between SERa+ and SERa- cycles as well as between SERa+ and SERa- oocytes. RESULTS: The presence of SERa was not associated with an adverse effect on embryological, clinical or neonatal data for SERa+ cycles and oocytes. Seven healthy babies were born from embryos originating from SERa+ oocytes. CONCLUSIONS: These results are encouraging and might contribute in the future to a revision of the Alpha-ESHRE Consensus. Larger studies, including a correlation between frequency and size of SERa, clinical outcomes and malformation rates, as well as the follow-up of babies born are nevertheless necessary. In the meantime, the currently conflicting data requires caution when considering transfers of embryos affected by SERa.

Policy of IVF centres towards oocytes affected by Smooth Endoplasmic Reticulum aggregates: a multicentre survey study.

PURPOSE: The presence of Smooth Endoplasmic Reticulum aggregates (SERa) has been reported to be associated with adverse outcomes. An Alpha-ESHRE Consensus was published in 2011, strongly recommending to not inseminating affected oocytes. On the other hand, healthy babies have been born from oocytes presenting this dysmorphism. We surveyed several European IVF centres, to assess their attitudes concerning affected oocytes. METHODS: This survey is based on a computer format and includes questions regarding the fate of affected oocytes. RESULTS: About 14 % of centres who answered our survey discard SERa+ oocytes. 43 % of centres that do not discard the oocytes, register and follow up neonatal data. About a quarter of centres inform their patients about this dysmorphism. Half of them require an informed consent prior to transferring affected embryos. Twenty-one centres reported having SERa+ births, with one reporting a malformation. 48 % of centres declared having been influenced by the Alpha-ESHRE Consensus, in their management policy of SERa+ oocytes. CONCLUSIONS: Few centres scrupulously respect the recommendations of the Alpha-ESHRE Consensus and discard affected oocytes. Since it is essential to determine if there truly is an impact of this dysmorphism and whether the guidelines are still valid, transfer of affected embryos should only be done when accompanied with data recording and monitoring of all foetal malformations from IVF. Clarifying the situation will allow IVF centres to correctly inform patients about the risk of birth malformations as well as whether a decreased chance of pregnancy exists.

Can healthy babies originate from oocytes with smooth endoplasmic reticulum aggregates? A systematic mini-review.

STUDY QUESTION: Is it time to reconsider whether oocytes affected by smooth endoplasmic reticulum aggregates (SERa) should still be destroyed? SUMMARY ANSWER: At the time of writing, the literature shows that 171 apparently healthy babies have been born from SERa+ cycles amongst which 22 were from SERa+ oocytes. WHAT IS KNOWN ALREADY: The SER dysmorphism has been associated with negative embryological, clinical and neonatal outcomes, which led to a recommendation in 2011 to avoid inseminating affected oocytes. The data in the literature are nevertheless conflicting and some centres have continued using SERa+ oocytes. STUDY DESIGN, SIZE, DURATION: A systematic mini-review of the literature to 7 November 2013 was performed with the keywords 'Smooth Endoplasmic Reticulum' and 'oocyte', limited to humans and written in English. PARTICIPANTS/MATERIALS, SETTING, METHODS: Articles (Pubmed) and major abstracts where the effect of the SER dysmorphism was studied as an individual feature on embryological, clinical or neonatal outcomes were included in this review. MAIN RESULTS AND THE ROLE OF CHANCE: From a total of 297 publications identified, 13 were selected as being relevant to this review. One hundred eighty-three babies have been reported to be born from SERa+ cycles, 171 were healthy, 8 live births presented malformations, 3 were neonatal deaths, 1 was a stillborn and additionally 4 terminations of pregnancy occurred. LIMITATIONS, REASONS FOR CAUTION: Data concerning SERa+ oocytes in the literature are scarce, the studies are small, heterogeneous and results are conflicting. The malformations observed could be due to over-reporting of scattered alarming results. Alternatively, an under-reporting of complications cannot be excluded. WIDER IMPLICATIONS OF THE FINDINGS: Centres that have or that are including transfers of SERa+ embryos in their IVF procedures should publish their clinical and neonatal outcomes as well as the follow-up of children. The birth of healthy babies from SERa+ embryos is encouraging and might lead in the future to a revision of the current consensus on the SER dysmorphism. Further research is needed to understand the origin of this dysmorphism and help avoid its occurrence. Therefore, until we have a better understanding of the situation, transfers of affected embryos should be carried out with caution. STUDY FUNDING/COMPETING INTEREST(S): We have no conflicts of interest to declare and no funding was received.

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.