Novel Gonadotrophin Releasing Hormone (GnRH) antagonist treatments have recently been developed in combination with hormonal add-back therapy, as an oral treatment option for women suffering from uterine fibroids. Registration trials assessing the GnRH antagonist combination preparations with relugolix, elagolix, and linzagolix have assessed treatment efficacy for fibroid related heavy menstrual blood loss in comparison to placebo. Marketing authorization has already been granted by several agencies including those in Europe, the United Kingdom, and the United States. Prior to marketing authorization, the European Medicines Agency recommends that Phase III registration trails should assess treatment efficacy in a representative study population, assess relevant outcomes with a comparison to gold-standard alternative treatment options and that long-term safety data will adequately be collected. In this review, we demonstrate limitations in the trial data generated to date, namely a lack of generalizability due to the restricted population studied, the absence of any comparison to alternative treatment methods, and findings limited to specific subgroups of patients because of the type of outcomes assessed. Symptoms related to uterine fibroids adversely affect many women’s quality of life and effective medical treatments are lacking. However, despite the urgent need for effective treatments, it is vitally important that novel drugs, like combination oral GnRH antagonists, undergo sufficiently rigorous evaluation of safety, effectiveness, and cost-effectiveness in a representative population compared with alternative treatment methods before introduction into mainstream clinical practice.

A document by Nicola Curry. Click on the document to view its contents.

Objective: To determine the impact of the COVID-19 pandemic on surgery for severe endometriosis in the UK at a national, regional and centre-level. Design: Population-based national cohort study. Population: All women undergoing endometriosis surgery requiring dissection of the pararectal space in the UK from 2017 to 2020 inclusive. Methods: The British Society for Gynaecological Endoscopy (BSGE) collects data nationally on all operations for severe endometriosis which involve dissection of the pararectal space. Annual audits of this database were obtained from the BSGE. Publicly available data on COVID-19 deaths and population were obtained from the UK Office for National Statistics. Main outcome measures: Numbers of annual BSGE-registered endometriosis operations. Results: A total of 5916 operations were performed. The number of operations decreased by 49.4% overall between 2019 and 2020. The number of endometriosis centres remained the same, however the median number of operations per centre decreased from 21 to 12.5, with a median percentage decrease at each centre of 51.0% (IQR 29.4% – 75.0%). There was no significant change in the type of surgery performed. All 11 administrative regions of Great Britain had reduced numbers of BSGE-registered operations in 2020 compared with the average for 2017-2019, with a median 56.6% decrease (range 6.13% - 68.62%). Regional reduction in operations was significantly correlated with COVID-19 death rates (r=0.557, 95% CI of r 0.048 – 1.00, p=0.037). Conclusions: There has been a dramatic fall in the number of operations for severe endometriosis in Britain during the COVID-19 pandemic.

Objective To develop a survey evaluating women’s experience of outpatient hysteroscopy (OPH) to generate data for benchmarking services in the UK Design Quality improvement project and national survey. Setting 77 hospitals with OPH services collected data over two-months. Population 5151 women Methods The OPH-Patient Satisfaction Survey (OPH-PSS) was developed using a multi-disciplinary approach. Good practice guidance in hysteroscopy and existing survey’s provided content for the survey. Pilot testing identified aspects of the women’s OPH journey that contributed to a final survey that was rolled out nationally. Main outcome variable Adequacy of OPH services reflected in women’s experience of their OPH journey and the quality of care being delivered. Results The majority (3193, 76%) of hysteroscopic procedures were diagnostic. Most women (4485, 87%) received adequate information regarding OPH with 4581 (89%) agreeing that analgesia was discussed. 5033 (97%) felt involved in their care. Women commonly reported pain (4490, 87%), but >50% regarded this as slight. 1 in 10 women felt anxious. 1217 (26%) women experienced feeling faint. Overall, >90% (4,867) of women considered the OPH service good. The mean score rating for overall level of care was considerably high (9.7/10). Comparative pain scores for OPH vs the worst pain felt during a menstrual period showed OPH to be less painful, except for endometrial ablation (P=<0.001). Conclusion This novel survey, evaluating women’s experience of OPH (OPH-PSS), provides a useful tool for benchmarking OPH services. Overall, the information provided to women and their subsequent experience of OPH is good, but pain is common.

We are all likely to need a blood test, a biopsy or wind up on the wrong end of an endoscope. We know that the experience is not going to be pleasant. Many of us will revert to techniques to divert attention away from painful stimuli, such as counting forwards or backwards in our heads, deep breathing, imagining tranquil places or listening to music. But the paper published in this issue of BJOG by (Neo D et al, BJOG 2020; xxxx) shows us how we can distract patients in a more sophisticated way, using virtual reality (VR) technology. The procedure the research groups chose to investigate was outpatient hysteroscopy.Outpatient hysteroscopy is a key part of contemporary gynaecological practice. The procedure is acceptable to the vast majority of women, but most will experience some pain and, in a small proportion of women, this can be severe (Smith P, et al, BJOG 2019;126:891-899). Thus, outpatient hysteroscopy, being common and potentially painful, is a good health technology to evaluate the impact of VR technology on patient experienceDeo N et al, conducted a randomised trial of 40 women undergoing outpatient hysteroscopy for a variety of indications and simple therapeutic procedures were allowed such as biopsy, polypectomy and insertion of a Mirena® device. Women were allocated to standard care or “immersive and interactive video content using a portable, standalone VR headset”. The latter delivered a “guided relaxation experience” which included viewing an 8-minute, narrated video depicting “a calming rainforest and lake setting with animated wildlife, which could be explored by using the “head-tracker”.The preliminary results are impressive. Reduction in peri-procedural pain was statistically significant but more importantly the effect size of a 2cm (20%) difference on a 10cm visual analogue scale must be clinically significant. Reduction in anxiety scores were of a similar magnitude. However, the average hysteroscopy procedure duration was less than 4 minutes, which begs the question, is the cost, time and hassle of setting up and using VR technology worth it? Moreover, 16% of eligible women did not want to use the VR technology because of prior adverse experiences, anxiety or state a preference to see the procedure or use their own distraction media.No-one is going to change clinical practice on a sample of 40, but many practitioners will be energised to conduct larger scale trials to confirm these provisional results and to analyse more deeply the impact of immersive VR technology on reducing pain and anxiety associated with outpatient hysteroscopy. Future work should look at the type of VR technology, the context where it is deployed for what kind of procedure. The optimal VR programme may vary according to patient characteristics, the type of surgery and its duration. VR technology should be tested in more painful gynaecological interventions such as endometrial ablation, cervical biopsy and transvaginal egg collection. Moreover, the prospective benefit of VR need not be restricted to gynaecological practice but should be evaluated in a whole host of ambulatory procedures involving conscious patients.No disclosures: A completed disclosure of interest form is available to view online as supporting information.