Effectiveness and safety of menopause treatments: pitfalls of available evidence and future research need.

By 2050 more than 1.6 billion women worldwide will be of post-reproductive age, with >75% reporting severe menopausal symptoms. The last few years saw a gradual uplift in public awareness reaffirming the health needs of women with menopause. Still, effective translation of available evidence on menopause treatments is hindered by several methodological limitations and poor research conduct. We argue that a paradigm shift is required in menopause research to address the remaining knowledge gap and guide safe evidence-based care provision. A critical misconception across studies on menopause is the assumption that women represent a homogeneous group who respond similarly to a particular therapy irrespective of their exposure and individual risk factors. We highlight potential solutions to optimize the quality of future research in menopause including adopting robust trial methodology, standardize outcome reporting to capture quality-of-life measures, and improve lay patient and public involvement in future research.

Lifestyle interventions in women with polycystic ovary syndrome: A scoping systematic review of randomised evidence

Objective: Lifestyle interventions (LSI) are recommended as first-line treatment for polycystic ovary syndrome (PCOS), yet the strength of evidence underpinning LSIs effectiveness remains unclear. We systematically reviewed the literature on LSIs in PCOS, evaluated evidence quality and summarised recommendations for clinical practice. Material and methods: We searched MEDLINE, EMBASE and CENTRAL for all randomised trials evaluating any LSI in PCOS until April 2021. We extracted data on the LSIs’ characteristics, dietary composition, duration, implementation, compliance assessment, and reported outcomes. We evaluated the evidence gap using a network-map of evaluated interventions. Results: We screened 550 citations and included 79 trials (n=4659 women). Most trials were from high-income countries (57/79, 72%) over a decade ago (48/79, 61%) and enrolled obese/overweight women (57/77, 74%). BMI was the commonest reported outcome (58/79, 73%), followed by weight (49/79, 62%), and testosterone (45/79, 57%). More than half of the trials had high-risk of randomisation (51/79, 65%) and allocation bias (49/79, 62%). Only 27 were registered prospectively (27/79, 34%). Two-thirds evaluated a dietary intervention (70/79, 88%), most commonly a hypocaloric diet (32/70, 46%); nineteen evaluated a combined dietary with pharmacological intervention (19/79, 24%), six combined diet with physical or behavioural intervention (6/79, 8%), and only one trial included all four elements. Conclusions: Evidence on LSI in PCOS is of poor quality with high variations in trial design, comparisons, and outcome reporting. Hypocaloric diet is the most commonly recommended LSI intervention for primary care. Future trials are needed to evaluate pragmatic and simple LSIs in robust multicenter studies (AU)

Objetivo: Las intervenciones en el estilo de vida (LSI) se recomiendan como tratamiento de primera línea para el síndrome de ovario poliquístico (SOP), sin embargo, la solidez de la evidencia que respalda la efectividad de la LSI sigue sin estar clara. Revisamos sistemáticamente la literatura sobre la LSI en el SOP, evaluamos la calidad de la evidencia, y resumimos las recomendaciones para la práctica clínica. Material y métodos: Buscamos en MEDLINE, Embase y CENTRAL, todos los ensayos aleatorios que evaluaran cualquier LSI en el SOP hasta abril de 2021. Extrajimos datos sobre las características, la composición dietética, la duración, la implementación, la evaluación del cumplimiento y los resultados informados de los LSI. Evaluamos la brecha de evidencia utilizando un mapa de red de intervenciones evaluadas. Resultados: Examinamos 550 citas e incluimos 79 ensayos (n=4.659 mujeres). La mayoría de los ensayos se realizaron en países de ingresos altos (57/79, 72%), hace más de una década (48/79, 61%) e incluyeron mujeres obesas/con sobrepeso (57/77, 74%). El IMC fue el resultado informado con más frecuencia (58/79, 73%), seguido del peso (49/79, 62%) y la testosterona (45/79, 57%). Más de la mitad de los ensayos tuvieron alto riesgo de asignación al azar (51/79, 65%) y sesgo de asignación (49/79, 62%). Solo 27 se registraron de forma prospectiva (27/79, 34%). Dos tercios evaluaron una intervención dietética (70/79, 88%), más comúnmente una dieta hipocalórica (32/70, 46%); 19 evaluaron una dieta combinada con intervención farmacológica (19/79, 24%), 6 una dieta combinada con intervención física o conductual (6/79, 8%) y solo un ensayo incluyó los 4 elementos. Conclusiones: La evidencia sobre la LSI en el SOP es de mala calidad con grandes variaciones en el diseño de los ensayos, las comparaciones y los informes de resultados (AU)

Accuracy of imaging modalities for adnexal torsion: a systematic review and meta-analysis.

BACKGROUND: Adnexal torsion (AT), a serious gynaecological emergency, often presents with non-specific symptoms leading to delayed diagnosis. OBJECTIVE: To compare the test accuracy of ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI) to diagnose AT. SEARCH STRATEGY: We searched EMBASE, MEDLINE and Cochrane CENTRAL until December 2019. SELECTION CRITERIA: Studies reporting on the accuracy of any imaging modality (Index Test) in female patients (paediatric and adult) suspected of AT compared with surgical diagnosis and/or standard clinical/radiological follow-up period until resolution of symptoms (Reference Standard). DATA COLLECTION AND ANALYSIS: We assessed study quality using QUADAS-2. We conducted test accuracy meta-analysis using a univariate model or a hierarchical model. MAIN RESULTS: We screened 3836 citations, included 18 studies (1654 women, 665 cases), and included 15 in the meta-analyses. Ultrasound pooled sensitivity (n = 12, 1187 women) was 0.79 (95% CI 0.63-0.92) and specificity was 0.76 (95% CI 0.54-0.93), with negative and positive likelihood ratios of 0.29 (95% CI 0.13-0.66) and 4.35 (95% CI 2.03-9.32), respectively. Using Doppler with ultrasound (n = 7, 845 women) yielded similar sensitivity (0.80, 95% CI 0.67-0.93) and specificity (0.88, 95% CI 0.72-1.00). For MRI (n = 3, 99 women), the pooled sensitivity was 0.81 (95% CI 0.63-0.91) and specificity was 0.91 (95% CI 0.80-0.96). A meta-analysis for CT was not possible with two case-control studies and one cohort study (n = 3, 232 women). Its sensitivity range was 0.74-0.95 and specificity was 0.80-0.90. CONCLUSIONS: Ultrasound has good performance as a first-line diagnostic test for suspected AT. Magnetic resonance imaging could offer improved specificity to investigate complex ovarian morphology, but more evidence is needed. TWEETABLE ABSTRACT: To investigate adnexal torsion, ultrasound is a good first-line diagnostic test with a pooled sensitivity of 0.79 and specificity of 0.76.

Comparison of perinatal outcomes for all modes of second stage delivery in obstetric theatres: a retrospective observational study.

OBJECTIVE: To compare rates of vaginal delivery and adverse outcomes of instrumental delivery trials in obstetric theatre compared to primary emergency full dilation caesarean section. DESIGN: Retrospective cohort study. SETTING: University teaching hospital. POPULATION: Women with singleton, non-anomalous, pregnancy undergoing instrumental delivery trial in obstetric theatre. METHODS: Data were collected from consecutive cases during 2014 until 2018 using clinical records. Multivariate regression analysis was used comparing outcomes per first delivery method. MAIN OUTCOME MEASURES: Primary outcome was completion of vaginal delivery between all methods of instrumental delivery. Secondary outcome was a composite of immediate perinatal adverse outcomes for instrumental delivery modes and primary full dilation caesarean section. RESULTS: From 971 deliveries analysed: ventouse delivery was significantly less likely to achieve vaginal delivery compared with Keilland's forceps delivery (odds ratio [OR] 0.42, 95% CI 0.22-0.79). Once confounding factors were adjusted for, adverse outcome rates were less frequent in the Keilland's forceps group than with primary full dilation caesarean section (OR 0.37, 95% CI 0.16-0.81); however, the receiver operating characteristic curve produced from this model demonstrated a low predictive value (AUC 0.64). CONCLUSIONS: Attempting instrumental delivery in delivery suite theatre, as an alternative to primary emergency full dilation caesarean section, is both reasonable and safe. In this study, ventouse delivery performed poorly in comparison with other modes of instrumental delivery. Further research in the form of randomised controlled trials to identify the optimal mode of second stage delivery is paramount. TWEETABLE ABSTRACT: Instrumental delivery trials in theatre are safe but use of ventouse was associated with a higher rate of failure.

Provision of obstetrics and gynaecology services during the COVID-19 pandemic: a survey of junior doctors in the UK National Health Service.

OBJECTIVE: The coronavirus disease 2019 (COVID-19) pandemic is disrupting health services worldwide. We aimed to evaluate the provision of obstetrics and gynaecology services in the UK during the acute phase of the COVID-19 pandemic. DESIGN: Interview-based national survey. SETTING: Women's healthcare units in the National Health Service. POPULATION: Junior doctors in obstetrics and gynaecology. METHODS: Participants were interviewed by members of the UK Audit and Research in Obstetrics and Gynaecology trainees' collaborative between 28 March and 7 April 2020. We used a quantitative analysis for closed-ended questions and a thematic framework analysis for open comments. RESULTS: We received responses from 148/155 units (95%), most of the participants were in years 3-7 of training (121/148, 82%). Most completed specific training drills for managing obstetric and gynaecological emergencies in women with COVID-19 (89/148, 60.1%) and two-person donning and doffing of Personal Protective Equipment (PPE) (96/148, 64.9%). The majority of surveyed units implemented COVID-19-specific protocols (130/148, 87.8%), offered adequate PPE (135/148, 91.2%) and operated dedicated COVID-19 emergency theatres (105/148, 70.8%). Most units reduced face-to-face antenatal clinics (117/148, 79.1%) and suspended elective gynaecology services (131/148, 88.5%). The 2-week referral pathway for oncological gynaecology was not affected in half of the units (76/148, 51.4%), but half reported a planned reduction in oncology surgery (82/148, 55.4%). CONCLUSION: The provision of obstetrics and gynaecology services in the UK during the acute phase of the COVID-19 pandemic seems to be in line with current guidelines, but strategic planning is needed to restore routine gynaecology services and ensure safe access to maternity care in the long term. TWEETABLE ABSTRACT: Provision of obstetrics and gynaecology services during the acute phase of COVID-19 is in line with current guidelines, strategic planning is needed to restore routine services and ensure safe access to care in the long term.

Training on Kielland's forceps: A survey of trainees' opinions.

We conducted a cross-sectional survey including specialist trainees in obstetrics and gynaecology in the Health Education West Midlands region, UK, to capture their views and assess training opportunities on the use of Kielland's forceps. Half of the trainees in the region completed the survey (87/172, 50%). Only 31% of our trainees worked in units that supported the training on these forceps (27/87, 31%). The majority reported that they did not get enough exposure to using Kielland's forceps (53/87, 60.9%). Only a minority (5.7%, 5/87) felt confident to perform a Kielland's rotational delivery independently. The majority (64.3%, 56/87) were keen to continue using Kielland's forceps in the future if competent. More than two-thirds (86.2%, 75/87) felt that simulation could aid their training. There was large enthusiasm for training on the safe use of Kielland's forceps among trainees in obstetrics and gynaecology in the West Midlands region. A national assessment of training resources is needed to better plan training recourses on this complex skill.

Development of a core outcome set for epilepsy in pregnancy (E-CORE): a national multi-stakeholder modified Delphi consensus study.

OBJECTIVE: To develop a set of core outcomes for studies on pregnant women with epilepsy. DESIGN: Delphi consensus study. POPULATION: Healthcare professionals, and patient representatives with lived experience of epilepsy in the UK. METHODS: We used a modified Delphi method and a consultation meeting to achieve consensus. Potential outcomes were identified by systematic review, and were scored using a Likert scale anchored between 1 (least important) and 5 (most important). We included outcomes that scored ≥4 by >70% of participants, and outcomes that scored ≤2 by <15% of participants. MAIN OUTCOME MEASURES: Outcomes in studies on epilepsy in pregnancy. RESULTS: Seventy-five healthcare professionals completed the first round, 48 (64%) completed the second round, and 37 (49%) completed the third round of the survey. Twenty-four patient representatives participated. The final core outcome set included 31 outcomes in three domains: neurological, offspring, and obstetric. Outcomes in the neurological domain were seizure control in pregnancy and postpartum, status epilepticus, maternal mortality, drowning, sudden unexpected death in epilepsy, postnatal depression, and quality of life. Offspring domain included congenital abnormalities (major and minor), fetal anticonvulsant syndrome, neurodevelopment, autism disorder, neonatal clinical complications, admission to a neonatal intensive care unit, and anthropometric measurements. The obstetric domain included live birth, stillbirth, miscarriage, ectopic, termination of pregnancy, admission to a high dependency or intensive care unit, breastfeeding, mode of delivery, preterm birth, pre-eclampsia, and eclampsia. Outcomes specific for studies on anti-epileptic drugs (AEDs) included maternal AED toxicity, AED compliance, neonatal withdrawal symptoms, and neonatal haemorrhagic disease. CONCLUSION: Embedding this core set in future clinical trials will promote the standardisation of reporting to inform clinical practice. TWEETABLE ABSTRACT: A Delphi method identifying core outcomes for epilepsy in pregnancy. Final core set includes 31 outcomes.

Use of ultrasound in emergency gynaecology.

Ultrasound scan (USS) is an important tool for assessing and diagnosing early pregnancy and gynaecological emergencies. Providing an ultrasound scanning service at all hours would enable and ease prompt diagnosis and appropriate management. It would also help hospitals in reducing costs secondary to unnecessary admissions due to lack of ultrasound out of hours. We have conducted a retrospective observational study that looked into the out of hours admissions to a busy early pregnancy unit in a general district hospital, over a 3-month period. Our results highlight the important role and possible benefits of using ultrasound out of hours and prove it is a cost-effective approach. However, providing ultrasound scanning out of hours is affected by limitations of staff and resources at each unit. This could be avoided by following a multidisciplinary approach in acute services and providing more training for medical staff in ultrasound scanning.

User's acceptability of OvuSense: a novel vaginal temperature sensor for prediction of the fertile period.

Measuring changes in core body temperature provides a valid method to detect ovulation and increase fertility. 'OvuSense' is a novel vaginal sensor that can predict the fertility window by recording and analysing the changes in intravaginal temperature records. This study aimed to determine patients 'acceptability and satisfaction after using OvuSense'. We approached 13 women to complete a patient satisfaction survey after using OvuSense in a prospective, longitudinal, comparative study, to test its validity and accuracy in detecting ovulation over a minimum period of three cycles. All 13 women agreed to participate in this survey. The majority of the participants found the usage of the reader to be very easy; 76.9% of the women said it was extremely comfortable to use the device during the night and 76.9% found the idea of using the intravaginal reader to be very convenient. Overall, 69.2% of women were extremely satisfied using the device. The idea of detecting intravaginal core body temperature changes appears to be highly acceptable by women.

A rare case of primary bone lymphoma mimicking a pelvic abscess.

Primary bone lymphoma (PBL) is a rare, malignant, neoplastic disorder of the skeleton that accounts for less than 5% of all primary bone tumours. We present an extremely rare case of PBL mimicking a pelvic abscess around the sacroiliac joint, which has never been reported in the medical literature, and discuss learning points highlighted from this case.