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Background: Multiple risk-prediction models are used in clinical practice to triage patients as being at low risk or high risk of ovarian cancer. In the ROCkeTS study, we aimed to identify the best diagnostic test for ovarian cancer in symptomatic patients, through head-to-head comparisons of risk-prediction models, in a real-world setting. Here, we report the results for the postmenopausal cohort., Methods: In this multicentre, prospective diagnostic accuracy study, we recruited newly presenting female patients aged 16-90 years with non-specific symptoms and raised CA125 or abnormal ultrasound results (or both) who had been referred via rapid access, elective clinics, or emergency presentations from 23 hospitals in the UK. Patients with normal CA125 and simple ovarian cysts of smaller than 5 cm in diameter, active non-ovarian malignancy, or previous ovarian malignancy, or those who were pregnant or declined a transvaginal scan, were ineligible. In this analysis, only postmenopausal participants were included. Participants completed a symptom questionnaire, gave a blood sample, and had transabdominal and transvaginal ultrasounds performed by International Ovarian Tumour Analysis consortium (IOTA)-certified sonographers. Index tests were Risk of Malignancy 1 (RMI1) at a threshold of 200, Risk of Malignancy Algorithm (ROMA) at multiple thresholds, IOTA Assessment of Different Neoplasias in the Adnexa (ADNEX) at thresholds of 3% and 10%, IOTA SRRisk model at thresholds of 3% and 10%, IOTA Simple Rules (malignant vs benign, or inconclusive), and CA125 at 35 IU/mL. In a post-hoc analysis, the Ovarian Adnexal and Reporting Data System (ORADS) at 10% was derived from IOTA ultrasound variables using established methods since ORADS was described after completion of recruitment. Index tests were conducted by study staff masked to the results of the reference standard. The comparator was RMI1 at the 250 threshold (the current UK National Health Service standard of care). The reference standard was surgical or biopsy tissue histology or cytology within 3 months, or a self-reported diagnosis of ovarian cancer at 12 month follow-up. The primary outcome was diagnostic accuracy at predicting primary invasive ovarian cancer versus benign or normal histology, assessed by analysing the sensitivity, specificity, C-index, area under receiver operating characteristic curve, positive and negative predictive values, and calibration plots in participants with conclusive reference standard results and available index test data. This study is registered with the International Standard Randomised Controlled Trial Number registry (ISRCTN17160843)., Findings: Between July 13, 2015, and Nov 30, 2018, 1242 postmenopausal patients were recruited, of whom 215 (17%) had primary ovarian cancer. 166 participants had missing, inconclusive, or other reference standard results; therefore, data from a maximum of 1076 participants were used to assess the index tests for the primary outcome. Compared with RMI1 at 250 (sensitivity 82·9% [95% CI 76·7 to 88·0], specificity 87·4% [84·9 to 89·6]), IOTA ADNEX at 10% was more sensitive (difference of -13·9% [-20·2 to -7·6], p<0·0001) but less specific (difference of 28·5% [24·7 to 32·3], p<0·0001). ROMA at 29·9 had similar sensitivity (difference of -3·6% [-9·1 to 1·9], p=0·24) but lower specificity (difference of 5·2% [2·5 to 8·0], p=0·0001). RMI1 at 200 had similar sensitivity (difference of -2·1% [-4·7 to 0·5], p=0·13) but lower specificity (difference of 3·0% [1·7 to 4·3], p<0·0001). IOTA SRRisk model at 10% had similar sensitivity (difference of -4·3% [-11·0 to -2·3], p=0·23) but lower specificity (difference of 16·2% [12·6 to 19·8], p<0·0001). IOTA Simple Rules had similar sensitivity (difference of -1·6% [-9·3 to 6·2], p=0·82) and specificity (difference of -2·2% [-5·1 to 0·6], p=0·14). CA125 at 35 IU/mL had similar sensitivity (difference of -2·1% [-6·6 to 2·3], p=0·42) but higher specificity (difference of 6·7% [4·3 to 9·1], p<0·0001). In a post-hoc analysis, when compared with RMI1 at 250, ORADS achieved similar sensitivity (difference of -2·1%, 95% CI -8·6 to 4·3, p=0·60) and lower specificity (difference of 10·2%, 95% CI 6·8 to 13·6, p<0·0001)., Interpretation: In view of its higher sensitivity than RMI1 at 250, despite some loss in specificity, we recommend that IOTA ADNEX at 10% should be considered as the new standard-of-care diagnostic in ovarian cancer for postmenopausal patients., Funding: UK National Institute of Heath Research., Competing Interests: Declaration of interests SS reports a research grant from AoA Diagnostics for work with samples collected in this study but not reported within this manuscript. SS reports honoraria from AstraZeneca, Merck, and GSK and consultancy from GSK and Immunogen, all unrelated to this work. TB reports grants, personal fees, and travel support from Samsung Medison; travel support from Roche Diagnostics; and personal fees from GE Healthcare, all outside the submitted work. BVC and DT report consultancy work done by KU Leuven to help the implementation and testing of the IOTA ADNEX model in ultrasound machines by Samsung Medison and GE Healthcare, outside the submitted work. UM declares stock ownership awarded by University College London until October, 2021, in Abcodia. UM and AG-M report research collaboration contracts with QIMR Berghofer Medical Research Institute, iLOF (intelligent Lab on Fiber), RNA Guardian, Micronoma, Mercy Bioanalytics, and Synteny Biotechnology. SK reports an honorary role as an Ovacome charity trustee. DT, TB, and BVC are IOTA steering group members and developed the IOTA models. All other authors declare no competing interests., (Copyright © 2024 The Authors. Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Recurrence of symptoms following an operation is common. Although hormonal treatment can reduce this risk, there is uncertainty about the best option., Objectives: To evaluate the clinical and cost-effectiveness of long-acting progestogen therapy compared with the combined oral contraceptive pill in preventing recurrence of endometriosis-related pain and quality of life., Design: A multicentre, open, randomised trial with parallel economic evaluation. The final design was informed by a pilot study, qualitative exploration of women's lived experience of endometriosis and a pretrial economic model., Setting: Thirty-four United Kingdom hospitals., Participants: Women of reproductive age undergoing conservative surgery for endometriosis., Interventions: Long-acting progestogen reversible contraceptive (either 150 mg depot medroxyprogesterone acetate or 52 mg levonorgestrel-releasing intrauterine system) or combined oral contraceptive pill (30 µg ethinylestradiol, 150 µg levonorgestrel)., Main Outcome Measures: The primary outcome was the pain domain of the Endometriosis Health Profile-30 questionnaire at 36 months post randomisation. The economic evaluation estimated the cost per quality-adjusted life-years gained., Results: Four hundred and five women were randomised to receive either long-acting reversible contraceptive ( N  = 205) or combined oral contraceptive pill ( N  = 200). Pain scores improved in both groups (24 and 23 points on average) compared with preoperative values but there was no difference between the two (adjusted mean difference: -0.8, 95% confidence interval -5.7 to 4.2; p  = 0.76). The long-acting reversible contraceptive group underwent fewer surgical procedures or second-line treatments compared with the combined oral contraceptive group (73 vs. 97; hazard ratio 0.67, 95% confidence interval 0.44 to 1.00). The mean adjusted quality-adjusted life-year difference between two arms was 0.043 (95% confidence interval -0.069 to 0.152) in favour of the combined oral contraceptive pill, although this cost an additional £533 (95% confidence interval 52 to 983) per woman., Limitations: Limitations include the absence of a no-treatment group and the fact that many women changed treatments over the 3 years of follow-up. Use of telephone follow-up to collect primary outcome data in those who failed to return questionnaires resulted in missing data for secondary outcomes. The COVID pandemic may have affected rates of further surgical treatment., Conclusions: At 36 months, women allocated to either intervention had comparable levels of pain, with both groups showing around a 40% improvement from presurgical levels. Although the combined oral contraceptive was cost-effective at a threshold of £20,000 per quality-adjusted life-year, the difference between the two was marginal and lower rates of repeat surgery might make long-acting reversible contraceptives preferable to some women., Future Work: Future research needs to focus on evaluating newer hormonal preparations, a more holistic approach to symptom suppression and identification of biomarkers to diagnose endometriosis and its recurrence., Trial Registration: This trial is registered as ISRCTN97865475. https://doi.org/10.1186/ISRCTN97865475., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 11/114/01) and is published in full in Health Technology Assessment ; Vol. 28, No. 55. See the NIHR Funding and Awards website for further award information. The NIHR recognises that people have diverse gender identities, and in this report, the word 'woman' is used to describe patients or individuals whose sex assigned at birth was female, whether they identify as female, male or non-binary.

Background: Women who suffer an early pregnancy loss require specific clinical care, aftercare, and ongoing support. In the UK, the clinical management of early pregnancy complications, including loss is provided mainly through specialist Early Pregnancy Assessment Units. The COVID-19 pandemic fundamentally changed the way in which maternity and gynaecological care was delivered, as health systems moved to rapidly reconfigure and re-organise services, aiming to reduce the risk and spread of SARS-CoV-2 infection. PUDDLES is an international collaboration investigating the pandemic's impact on care for people who suffered a perinatal bereavement. Presented here are initial qualitative findings undertaken with UK-based women who suffered early pregnancy losses during the pandemic, about how they navigated the healthcare system and its restrictions, and how they were supported., Methods: In-keeping with a qualitative research design, in-depth semi-structured interviews were undertaken with an opportunity sample of women (N = 32) who suffered any early pregnancy loss during the COVID-19 pandemic. Data were analysed using a template analysis to understand women's access to services, care, and networks of support, during the pandemic following their pregnancy loss. The thematic template was based on findings from parents who had suffered a late-miscarriage, stillbirth, or neonatal death in the UK, during the pandemic., Results: All women had experienced reconfigured maternity and early pregnancy services. Data supported themes of: 1) COVID-19 Restrictions as Impractical & Impersonal; 2) Alone, with Only Staff to Support Them; 3) Reduction in Service Provision Leading to Perceived Devaluation in Care; and 4) Seeking Their Own Support. Results suggest access to early pregnancy loss services was reduced and pandemic-related restrictions were often impractical (i.e., restrictions added to burden of accessing or receiving care). Women often reported being isolated and, concerningly, aspects of early pregnancy loss services were reported as sub-optimal., Conclusions: These findings provide important insight for the recovery and rebuilding of health services in the post-pandemic period and help us prepare for providing a higher standard of care in the future and through any other health system shocks. Conclusions made can inform future policy and planning to ensure best possible support for women who experience early pregnancy loss., (© 2024. The Author(s).)

Background: Better use of healthcare systems data, collected as part of interactions between patients and the healthcare system, could transform planning and conduct of randomised controlled trials. Multiple challenges to widespread use include whether healthcare systems data captures sufficiently well the data traditionally captured on case report forms. "Data Utility Comparison Studies" (DUCkS) assess the utility of healthcare systems data for RCTs by comparison to data collected by the trial. Despite their importance, there are few published UK examples of DUCkS., Methods-And-Results: Building from ongoing and selected recent examples of UK-led DUCkS in the literature, we set out experience-based considerations for the conduct of future DUCkS. Developed through informal iterative discussions in many forums, considerations are offered for planning, protocol development, data, analysis and reporting, with comparisons at "patient-level" or "trial-level", depending on the item of interest and trial status., Discussion: DUCkS could be a valuable tool in assessing where healthcare systems data can be used for trials and in which trial teams can play a leading role. There is a pressing need for trials to be more efficient in their delivery and research waste must be reduced. Trials have been making inconsistent use of healthcare systems data, not least because of an absence of evidence of utility. DUCkS can also help to identify challenges in using healthcare systems data, such as linkage (access and timing) and data quality. We encourage trial teams to incorporate and report DUCkS in trials and funders and data providers to support them., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. CB is now employed at Insitro, South San Francisco, CA. Insitro had no involvement in the design or implementation of the work presented here., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Research has shown that many babies who die in neonatal units could have been potential tissue and/or organ donors. Despite the existence of guidelines supporting its implementation, the incidence of neonatal donation remains rare in the United Kingdom., Aim: The aim of this audit was to retrospectively determine potential eligibility for neonatal tissue and/or organ donation referral in infants who died in a single UK tertiary-level neonatal unit between 2012 and 2021. Cause of death and documentation of any discussions held regarding referral for donation were also explored., Study Design: An audit was undertaken to identify all neonatal deaths at a single tertiary-level NICU in London from 2012-2021. Infants who retrospectively could have been referred as potential tissue and/or organ donors were identified using current NHS Blood and Transplant inclusion and exclusion criteria., Results and Conclusion: A significant missed potential for neonatal tissue and/or organ donation referrals was identified, which is likely not just limited to the unit audited. Causes of death were as expected for a tertiary level neonatal unit and centre for therapeutic cooling of babies born with hypoxic perinatal brain injuries. Only one documented conversation was found regarding neonatal donation., Relevance to Clinical Practice: To enable conversations regarding neonatal donation to become a routine part of end-of-life care discussions with families as appropriate, good links between neonatal healthcare professionals and Specialist Nurses in Organ Donation need to be established. This will facilitate the referral of all suitable neonates as potential donors and ensure that neonatal staff feel supported to care for babies identified as potential donors., (© 2023 British Association of Critical Care Nurses.)

Objective: UKCTOCS provides an opportunity to explore symptoms in preclinical invasive epithelial ovarian cancer (iEOC). We report on symptoms in women with pre-clinical (screen-detected) cancers (PC) compared to clinically diagnosed (CD) cancers., Methods: In UKCTOCS, 202638 postmenopausal women, aged 50-74 were randomly allocated (April 17, 2001-September 29, 2005) 2:1:1 to no screening or annual screening till Dec 31,2011, using a multimodal or ultrasound strategy. Follow-up was through national registries. An outcomes committee adjudicated on OC diagnosis, histotype, stage. Eligible women were those diagnosed with iEOC at primary censorship (Dec 31, 2014). Symptom details were extracted from trial clinical-assessment forms and medical records. Descriptive statistics were used to compare symptoms in PC versus CD women with early (I/II) and advanced (III/IV/unable to stage) stage high-grade-serous (HGSC) cancer. ISRCTN-22488978; ClinicalTrials.gov-NCT00058032., Results: 1133 (286PC; 847CD) women developed iEOC. Median age (years) at diagnosis was earlier in PC compared to CD (66.8PC, 68.7CD, p = 0.0001) group. In the PC group, 48% (112/234; 90%, 660/730CD) reported symptoms when questioned. Half PC (50%, 13/26PC; 36%, 29/80CD; p = 0.213) women with symptomatic HGSC had >1symptom, with abdominal symptoms most common, both in early (62%, 16/26, PC; 53% 42/80, CD; p = 0.421) and advanced (57%, 49/86, PC; 74%, 431/580, CD; p = 0.001) stages. In symptomatic early-stage HGSC, compared to CD, PC women reported more gastrointestinal (change in bowel habits and dyspepsia) (35%, 9/26PC; 9%, 7/80CD; p = 0.001) and systemic (mostly lethargy/tiredness) (27%, 7/26PC; 9%, 7/80CD; p = 0.017) symptoms., Conclusions: Our findings, add to the growing evidence, that we should reconsider what constitutes alert symptoms for early tubo-ovarian cancer. We need a more nuanced complex of key symptoms which is then evaluated and refined in a prospective trial., Competing Interests: Declaration of Competing Interest UM had stock ownership awarded by University College London (UCL) between until October 2021 in Abcodia, which holds the licence for ROCA. She and MP have received grants and AGM, MB, JK and AR have been funded by grants from the Medical Research Council (MRC), Cancer Research UK, National Institute for Health Research (NIHR) and The Eve Appeal. UM has also received grants from UK Innovate and National Health and Medical Research Council (NHMRC), Australia and salary support from UCL Hospital Biomedical Research Centre. UM, AGM and SA report funded research collaborations with industry - iLOF (intelligent Lab on Fiber), RNA Guardian, Micronoma, MercyBio Analytics and academics -Cambridge University, QIMR Berghofer Medical Research Institute Imperial College London, University of Innsbruck and Dana Farber USA. UM holds patent number EP10178345.4 for Breast Cancer Diagnostics. AGM is a member of ACED Gynaecological Cancer Working Group and is ACED Co-Director Research Domain Trials. MP was an Associate Member of the EME funding committee while the project was active. SJS reports that Massachusetts General Hospital (MGH) has co-licensed software for ROCA to Abcodia, now owned by GenInCode, with MGH licence revenue to MGH and research laboratories per MGH institutional policies. SJS receives grant support from National Cancer Institute (USA) and National Institute for Health Research (NIHR) (UK). He is paid for service on the clinical advisory board for Guardant Health. He serves on the Scientific Advisory Board for LUNGevity. He has stock options from SISCAPA Assay Technologies for participation on its Scientific Advisory Board. IJJ reports grants from Eve Appeal Charity, MRC, Cancer Research UK, and NIHR during the conduct of the study. He co-invented the ROCA in 1995. Massachusetts General Hospital and Queen Mary University of London granted a licence for the ROCA to Abcodia in 2014. IJJ is non-executive director, shareholder, and consultant to Abcodia and has rights to royalties from sales of the ROCA. He founded (1985), was a trustee of (2012–14), and is now an Emeritus trustee (2015–present) of The Eve Appeal, one of the funding agencies for UKCTOCS. LF reports MRC funding for the psychosocial arm of the UKCTOCS study 2001–13, paid to University of Sussex. NS received honoraria from Astra-Zeneca-MPC and GlaxoSmithKline for participation in advisory boards. AMcG was a member of NIHR HTA and EME Editoral Board (2012 to 2022). RM reports funding from The Eve Appeal, Rosetrees Trust, Barts Charity, Yorkshire Cancer Research, Ovacure, British Gynaecological Cancer Society (BGCS), GlaxoSmithKline (GSK), and Honoraria from Astrazeneca and EGL. All other authors declare no competing interests., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Study Question: Does maternal infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the first trimester affect the risk of miscarriage before 13 week's gestation?, Summary Answer: Pregnant women with self-reported diagnosis of SARS-CoV-2 in the first trimester had a higher risk of early miscarriage., What Is Known Already: Viral infections during pregnancy have a broad spectrum of placental and neonatal pathology. Data on the effects of the SARS-CoV-2 infection in pregnancy are still emerging. Two systematic reviews and meta-analyses reported an increased risk of preterm birth, caesarean delivery, maternal morbidity and stillbirth. Data on the impact of first trimester infection on early pregnancy outcomes are scarce. This is the first study, to our knowledge, to investigate the rates of early pregnancy loss during the SARS-CoV-2 outbreak among women with self-reported infection., Study Design, Size, Duration: This was a nationwide prospective cohort study of pregnant women in the community recruited using social media between 21 May and 31 December 2020. We recruited 3545 women who conceived during the SARS-CoV-2 pandemic who were <13 week's gestation at the time of recruitment., Participants/materials, Setting, Methods: The COVID-19 Contraception and Pregnancy Study (CAP-COVID) was an on-line survey study collecting longitudinal data from pregnant women in the UK aged 18 years or older. Women who were pregnant during the pandemic were asked to complete on-line surveys at the end of each trimester. We collected data on current and past pregnancy complications, their medical history and whether they or anyone in their household had symptoms or been diagnosed with SARS-CoV-2 infection during each trimester of their pregnancy. RT-PCR-based SARS-CoV-2 RNA detection from respiratory samples (e.g. nasopharynx) is the standard practice for diagnosis of SARS-CoV-2 in the UK. We compared rate of self-reported miscarriage in three groups: 'presumed infected', i.e. those who reported a diagnosis with SARS-CoV-2 infection in the first trimester; 'uncertain', i.e. those who did not report a diagnosis but had symptoms/household contacts with symptoms/diagnosis; and 'presumed uninfected', i.e. those who did not report any symptoms/diagnosis and had no household contacts with symptoms/diagnosis of SARS-CoV-2., Main Results and the Role of Chance: A total of 3545 women registered for the CAP-COVID study at <13 weeks gestation and were eligible for this analysis. Data for the primary outcome were available from 3041 women (86%). In the overall sample, the rate of self-reported miscarriage was 7.8% (238/3041 [95% CI, 7-9]). The median gestational age (GA) at miscarriage was 9 weeks (interquartile range 8-11). Seventy-seven women were in the 'presumed infected' group (77/3041, 2.5% [95% CI 2-3]), 295/3041 were in the uncertain group (9.7% [95% CI 9-11]) and the rest in the 'presumed uninfected' (87.8%, 2669/3041 [95% CI 87-89]). The rate of early miscarriage was 14% in the 'presumed infected' group, 5% in the 'uncertain' and 8% in the 'presumed uninfected' (11/77 [95% CI 6-22] versus 15/295 [95% CI 3-8] versus 212/2669 [95% CI 7-9], P = 0.02). After adjusting for age, BMI, ethnicity, smoking status, GA at registration and the number of previous miscarriages, the risk of early miscarriage appears to be higher in the 'presumed infected' group (relative rate 1.7, 95% CI 1.0-3.0, P = 0.06)., Limitations, Reasons for Caution: We relied on self-reported data on early pregnancy loss and SARS-CoV-2 infection without any means of checking validity. Some women in the 'presumed uninfected' and 'uncertain' groups may have had asymptomatic infections. The number of 'presumed infected' in our study was low and therefore the study was relatively underpowered., Wider Implications of the Findings: This was a national study from the UK, where infection rates were one of the highest in the world. Based on the evidence presented here, women who are infected with SARS-CoV-2 in their first trimester may be at an increased risk of a miscarriage. However, the overall rate of miscarriage in our study population was 8%. This is reassuring and suggests that if there is an effect of SARS-CoV-2 on the risk of miscarriage, this may be limited to those with symptoms substantial enough to lead to a diagnostic test. Further studies are warranted to evaluate a causal association between SARS-CoV-2 infection in early pregnancy and miscarriage risk. Although we did not see an overall increase in the risk of miscarriage, the observed comparative increase in the presumed infected group reinforces the message that pregnant women should continue to exercise social distancing measures and good hygiene throughout their pregnancy to limit their risk of infection., Study Funding/competing Interest(s): This study was supported by a grant from the Elizabeth Garrett Anderson Hospital Charity (G13-559194). The funders of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report. J.A.H. is supported by an NIHR Advanced Fellowship. A.L.D. is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre. All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi&#95;disclosure.pdf and declare: support to J.A.H. and A.L.D. as above; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work., Trial Registration Number: N/A., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Background: The objective of this study was to assess the impact of consultant presence, volume of patients seen and weekend opening on the health and cost-related outcomes associated with different Early Pregnancy Assessment Unit (EPAU) configurations., Methods: This was an observational study with a prospective cohort design. Six thousand six hundred six pregnant women (16 years of age and over) attending EPAUs because of suspected early pregnancy complications were recruited from 44 EPAUs across the UK. The main outcome measures were quality of life, costs, and anxiety., Results: Costs, quality of life and anxiety scores were similar across configurations with little evidence to suggest an impact of consultant presence, weekend opening or volume of patients seen. Mean overall costs varied from £92 (95% CI £85 - £98) for a diagnosis of normally developing pregnancy to £1793 (95% CI £1346 - £2240) for a molar pregnancy. EQ-5D-5L score increased from 0.85 (95% CI 0.84-0.86) at baseline to 0.91 (95% CI 0.90-0.92) at 4 weeks for the 573 women who completed questionnaires at both time points, largely due to improvements in the pain/discomfort and anxiety/depression dimensions. 78% of women reported a decrease in their anxiety score immediately following their EPAU appointment., Conclusions: EPAU configuration, as specified in this study, had limited impact on any of the outcomes examined. However, it is clear that care provided in the EPAU has a positive overall effect on women's health and emotional wellbeing, with significant improvements in EQ-5D and anxiety shown following an EPAU visit., (© 2022. The Author(s).)

Care for pregnant women and their infants at extremely low gestational ages challenges clinical teams. The continuing rise in survival at gestational ages below 25 weeks has prompted re-evaluation of practice guidelines within the UK and other countries. This paper describes the background data that have guided our practice, the approach that has been taken to deliver optimal outcomes for pregnancies delivering at extremely low gestational age in the UK, mainly through centralising care, and discusses the research and audit data that support our practice. In particular, we emphasize the importance of a coordinated perinatal approach to both mother and infant, and careful assessment of the risks to both, to ensure that we develop the highest quality personalized care for each family, supported by national quality improvement and research evidence., Competing Interests: Declaration of Competing Interest NM declares consulting fees with Novartis and Takeda outside the published work; other authors declare no conflicts of interest., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Importance: Children born preterm (<37 weeks' gestation) have a higher risk of visual impairment and ocular morbidities compared peers born at full term. However, the long-term ocular sequelae in adulthood for those born extremely preterm (EP), who have the highest risk of neonatal retinopathy, are unknown., Objective: To evaluate visual function and ocular morbidity in young adults born EP compared with controls born full term., Design, Setting, and Participants: This prospective cohort study of a geographically based birth cohort in the UK and Ireland born from March 1 through December 31, 1995, included 128 participants aged 19 years (born at 22-25 weeks' gestation) and 65 age-matched controls born at full term. Statistical analysis was performed from March 1, 2020, to November 26, 2021., Exposures: Participants underwent eye examinations as part of a comprehensive outcome evaluation., Main Outcomes and Measures: Best-corrected visual acuity, refractive status, contrast sensitivity, color vision, prevalence of strabismus and nystagmus, and patient-reported visual function, measured using the Health Utilities Index Mark 3., Results: The study comprised 128 participants (256 eyes; 68 female participants [53%]; mean [SD] age, 19.3 [0.5] years) and 65 age-matched controls born at full term (130 eyes; 40 female participants [62%]; mean [SD] age, 19.2 [0.5] years). Compared with control eyes, the mean (SD) best-corrected visual acuity among eyes in the EP group was significantly worse (monocular vision: -0.06 [0.14] logMAR in the control group vs 0.14 [0.38] logMAR in the EP group; P < .001; binocular vision: -0.14 [0.15] logMAR in the control group vs 0.06 [0.37] logMAR in the EP group; P < .001). Participants in the EP group had a significantly higher prevalence of strabismus (36% [46 of 127] vs 0%; P < .001), abnormal ocular motility (15% [19 of 125] vs 0%; P < .001), and nystagmus (13% [16 of 127] vs 0%; P < .001) than the control group. No significant differences between participants in the EP group and controls were observed for refractive error, contrast sensitivity, color vision, or patient-reported visual function. Among the participants in the EP group, 48% of eyes (120 of 250) had no retinopathy of prematurity (ROP), 39% (98 of 250) had ROP not requiring neonatal treatment, and 13% (32 of 250) received cryotherapy or laser ablation for ROP. Within the EP group, there was no significant difference in binocular visual function parameters, prevalence of ocular morbidity, and patient-reported visual function by neonatal ROP status., Conclusions and Relevance: Extreme prematurity is associated with an increased prevalence of visual and ocular deficits in young adulthood; this study suggests that, for individuals born EP, visual and ocular deficits appear to be partially independent of ROP status in the neonatal period but reports similar overall visual function.

Objective: To explore the experiences of women who had used an Early Pregnancy Assessment Unit (EPAU) service in the UK and make recommendations for their improvement., Design: Qualitative interview study., Setting: Early Pregnancy Assessment Units in the UK., Sample: A maximum variation sample of women who had consented to be interviewed having attended one of 26 EPAUs involved in the VESPA study in 2018., Methods: In-depth telephone interviews with 38 women. A thematic framework analysis was conducted, with a focus on how experiences varied according to EPAU service configuration and clinical pathway., Main Outcome Measures: Women's experiences of EPAU services., Results: We found that EPAUs are highly valued, and women's experiences were generally positive. However, women reported a range of issues that negatively affected their experience. These included difficulties accessing the service, insensitive management of the investigation and treatment options of pregnancy loss, poor communication, insufficient information and a lack of support for their psychological health. These issues were not strongly associated with EPAU configuration or clinical pathway., Conclusions: Recommendations to improve women's experiences include the separation of EPAUs from general maternity services, and we make suggestions on how to remove barriers to access by reviewing opening hours, how to provide sensitive patient management, such as automatically cancelling appointments and scans following pregnancy loss, and how to improve communication, both with women and their partners as well as with other parts of the health service., Tweetable Abstract: Early Pregnancy Assessment Units are highly valued by women but aspects of their care experiences, particularly around sensitive management of pregnancy loss, could be improved., (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Objective: To explore women's experiences of maternity service reconfiguration during the first wave of the SARS-CoV-2 (COVID-19) pandemic., Design: Qualitative interview study., Setting: South London, United Kingdom., Participants: Women (N=23) who gave birth between March and August 2020 in one of the ten South London maternity hospitals., Methods: Semi-structured interviews were conducted (N=23), via video-conferencing software. Transcribed interviews were analysed 'by hand' using Microsoft Word. Template analysis was selected to code, analyse, and interpret data, according to the findings of a recently-published national survey of maternity service reconfiguration across the UK in response to COVID-19., Findings: Three main themes emerged through analysis: (i) Disruption to In-Person Care and Increased Virtual Care Provision, (ii) Changes to Labour and Birth Preferences and Plans, (iii) Advice for Navigating Maternity Services During a Pandemic., Key Conclusions: Women reported mixed views on the reduction in scheduled in-person appointments. The increase in remote care, especially via telephone, was not well endorsed by women. Furthermore, women reported an under-reliance on healthcare professionals for support, rather turning to family., Implications for Practice: We provide insight into the experiences of women who received antenatal, intrapartum, and postnatal care during the first wave of the COVID-19 pandemic. Our findings should inform healthcare policy to build back better maternity care services after the pandemic., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021. Published by Elsevier Ltd.)

Objective: To explore the concepts and strategies parents employ when considering maternal-fetal surgery (MFS) as an option for the management of spina bifida (SB) in their fetus, and how this determines the acceptability of the intervention., Methods: A two-centre interview study enrolling parents whose fetuses with SB were eligible for MFS. To assess differences in acceptability, parents opting for MFS (n = 24) were interviewed at three different moments in time: prior to the intervention, directly after the intervention and 3-6 months after birth. Parents opting for termination of pregnancy (n = 5) were interviewed only once. Themes were identified and organised in line with the framework of acceptability., Results: To parents opting for MFS, the intervention was perceived as an opportunity that needed to be taken. Feelings of parental responsibility drove them to do anything in their power to improve their future child's situation. Expectations seemed to be realistic yet were driven by hope for the best outcome. None expressed decisional regret at any stage, despite substantial impact and, at times, disappointing outcomes. For the small group of participants, who decided to opt for termination of pregnancy (TOP), MFS was not perceived as an intervention that substantially could improve the quality of their future child's life., Conclusion: Prospective parents opting for MFS were driven by their feelings of parental responsibility. They recognise the fetus as their future child and value information and care focusing on optimising the child's future health. In the small group of parents opting for TOP, MFS was felt to offer insufficient certainty of substantial improvement in quality of life and the perceived severe impact of SB drove their decision to end the pregnancy., (© 2021 John Wiley & Sons Ltd.)

Objective: Hyperechogenic kidneys are a relatively rare antenatal finding, which can generate significant parental anxiety due to uncertain prognosis. We report on the perinatal and infant outcomes of a large cohort of fetuses with antenatally diagnosed hyperechogenic kidneys., Methods: This was a retrospective analysis of all cases diagnosed prenatally with hyperechogenic kidneys between 2002 and 2017 in a large tertiary fetal medicine unit. Hyperechogenicity was defined as kidney parenchyma with greater echogenicity than that of the liver. Pregnancy, pathological and postnatal outcomes were collected from hospital and general practitioner records up to 1 year of age. Abnormal renal outcome was defined as elevated creatinine beyond 6 months of age, hypertension requiring medication or major kidney surgery, such as nephrectomy. Severe abnormal renal outcome was defined as the need for dialysis or kidney transplant at any stage., Results: Three-hundred and sixteen fetuses with hyperechogenic kidneys were identified at a mean gestational age of 21 (range, 13-37) weeks. The majority of cases (97%) had bilateral hyperechogenic kidneys. In the 265 cases with available follow-up data, other associated renal tract abnormalities were identified prenatally in 36%, concomitant extrarenal structural abnormalities in 39% and abnormal karyotype in 15% of cases. Of the 316 included cases, 139 did not survive, including 105 terminations of pregnancy, five intrauterine deaths and 29 early neonatal deaths. Only 4.3% (6/139) of these fetuses had isolated hyperechogenic kidneys while 28.1% (39/139) had associated multiple renal tract abnormalities alongside hyperechogenic kidneys and over two-thirds (67.6%; 94/139) had concomitant extrarenal abnormalities. Of the 177 cases that survived beyond 1 month of age, outcome data were available in 126. Of these, based on the antenatal findings, 60 (47.6%) cases had isolated hyperechogenic kidneys, 56 (44.4%) had associated renal structural abnormalities and 10 (7.9%) had additional extrarenal abnormalities. Considering renal outcome alone, kidney function was abnormal in 13 (21.7%), 10 (17.9%) and 0 (0%) infants in these three groups, respectively, although concurrent pathology clearly affected global outcome in the more complex cases. Neonatal mortality of 1.6% was observed in the isolated renal hyperechogenicity group. The presence of oligohydramnios or abnormal renal volume was not associated significantly with abnormal renal function (odds ratio (OR), 2.32 (99% CI, 0.54-10.02) and OR, 0.74 (99% CI, 0.21-2.59), respectively) in this group., Conclusions: Hyperechogenic kidneys are often complicated by associated renal tract and extrarenal abnormalities, aberrant karyotype and genetic disease, and these factors have a greater effect on overall outcome than does kidney echogenicity. The renal outcome of fetuses with isolated hyperechogenic kidneys is good generally, with over 70% of cases having normal renal function postpartum. Importantly, for prognostic counseling, all of the fetuses in this non-selected series with isolated hyperechogenic kidneys and normal amniotic fluid levels had normal renal outcome in infancy. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology., (© 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.)

Background: When the vulnerabilities of the postnatal period are combined with the impact of the COVID-19 pandemic, psychosocial outcomes are likely to be affected. Specifically, we aim to: a) explore the psychosocial experiences of women in the early postnatal period; b) describe prevalence rates of clinically relevant maternal anxiety and depression; and c) explore whether psychosocial change occurring as a result of COVID-19 is predictive of clinically relevant maternal anxiety and depression., Methods: A sample of UK mothers (N = 614) with infants aged between birth and twelve weeks were recruited via convenience sampling. A cross-sectional survey design was utilised which comprised demographics, COVID-19 specific questions, and a battery of validated psychosocial measures, including the EPDS and STAI-S which were used to collect prevalence rates of clinically relevant depression and anxiety respectively. Data collection coincided with the UK government's initial mandated "lockdown" restrictions and the introduction of social distancing measures in 2020., Findings: Descriptive findings from the overall sample indicate that a high percentage of mothers self-reported psychological and social changes as a result of the introduction of social distancing measures. For women who reported the presence of psychosocial change, these changes were perceived negatively. Whilst seventy women (11.4%) reported a current clinical diagnosis of depression, two hundred and sixty-four women (43%) reported a score of ≥13 on the EPDS, indicating clinically relevant depression. Whilst one hundred and thirteen women (18.4%) reported a current clinical diagnosis of anxiety, three hundred and seventy-three women (61%) reported a score of ≥40 on STAI-S, indicating clinically relevant anxiety. After accounting for current clinical diagnoses of depression or anxiety, and demographic factors known to influence mental health, only perceived psychological change occurring as a result of the introduction of social distancing measures predicted unique variance in the risk of clinically relevant maternal depression (30%) and anxiety (33%)., Interpretation: To our knowledge, this is the first national study to examine the psychosocial experiences of postnatal women during the COVID-19 pandemic in the UK. Prevalence rates of clinically relevant maternal depression and anxiety were extremely high when compared to both self-reported current diagnoses of depression and anxiety, and pre-pandemic prevalence studies. Perceived psychological changes occurring as a result of the introduction of social distancing measures predicted unique variance in the risk for clinically relevant maternal depression and anxiety. This study provides vital information for clinicians, funders, policy makers, and researchers to inform the immediate next steps in perinatal care, policy, and research during COVID-19 and future health crises., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in women with a twin pregnancy and a short cervix., Methods and Findings: We conducted an open-label randomised controlled trial in 57 hospital antenatal clinics in the UK and Europe. From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation. In total, 503 women with cervical length ≤ 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or standard care alone (n = 253, mean age 32.7 years, mean cervical length 30 mm). The pessary was inserted before 21 completed weeks of gestation and removed at between 35 and 36 weeks or before birth if earlier. The primary obstetric outcome, spontaneous onset of labour and birth before 34 weeks 0 days of gestation, was present in 46/250 (18.4%) in the pessary group compared to 52/253 (20.6%) following standard care alone (adjusted odds ratio [aOR] 0.87 [95% CI 0.55-1.38], p = 0.54). The primary neonatal outcome-a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery-was present in 67/500 infants (13.4%) in the pessary group compared to 76/506 (15.0%) following standard care alone (aOR 0.86 [95% CI 0.54-1.36], p = 0.50). The positive and negative likelihood ratios of a short cervix (≤35 mm) to predict preterm birth before 34 weeks were 2.14 and 0.83, respectively. A meta-analysis of data from existing publications (4 studies, 313 women) and from STOPPIT-2 indicated that a cervical pessary does not reduce preterm birth before 34 weeks in women with a short cervix (risk ratio 0.74 [95% CI 0.50-1.11], p = 0.15). No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53). Study limitations include lack of power to exclude a smaller than 40% reduction in preterm labour associated preterm birth, and to be conclusive about subgroup analyses., Conclusions: These results led us to reject our hypothesis that the Arabin pessary would reduce the risk of the primary outcome by 40%. Smaller treatment effects cannot be ruled out., Trial Registration: ISRCTN Registry ISRCTN 02235181. ClinicalTrials.gov NCT02235181., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests. JEN has received grants from government and charitable bodies for research into understanding the mechanism of term and preterm labour and understanding treatments. Within the last 3 years she has acted on a Data Safety and Monitoring Board for a study involving a preterm birth therapeutic agent for Glaxo Smith Kline, and has provided consultancy for Dilafor on drugs to alter labour progress. PRB reports personal fees from ObsEva Geneva, other from ObsEva Geneva, outside the submitted work; In addition, PRB has a patent PCT/GB1997/000529 WO1997031631 A1 Cox-2 selective inhibitors for managing labour and uterine contractions issued, a patent PCT/GB2004/001380 WO2005053705 A1 Use of a cyclopentenone prostaglandin for delaying the onset and/or preventing the continuation of labour (Priority Date Dec 2, 2003). issued, a patent PCT/GB2016/050618 Circulating miRNAs predictive of cervical shortening and preterm birth (Pending UK filing 6th March 2015 /Full international filing completed 7th March 2016). issued, a patent PCT/GB2016/050621 Rapid evaporative ionisation mass spectroscopy (REIMS) and Desorbtion Electrospray Ionisation Mass Spectroscopy (DESI-MS) analysis of swabs and biopsy samples. (Pending UK filing 6th March 2015 /Full international filing completed 7th March 2016 pending, a patent PCT/GB2019 Desorbtion Electrospray Ionisation Mass Spectroscopy (DESI-MS) analysis of swabs to predict vaginal microbiota. (Pending UK filing March 2019) pending, and a patent PCT/GB2019/Circulating miRNAs predictive of IUGR (Pending UK filing March 2019) pending. SCB reports grants from other from NIHR, NETSCC, HTA during the conduct of the study and personal fees and other from University of Copenhagen, Wellcome Trust, NIHR Global Health Research and French Cancer Institute outside the submitted work. SJS reports grants from NIHR HTA during the conduct of the study; being a member of the NIHR HTA General committee and receiving received other research funding from the NIHR (14/32/01 QUIDS), Wellcome Trust (209560/Z/17/Z) and CSO During the course of the study. SJS is a member of PLOS Medicine’s Editorial Board. NM reports personal fees from Shire-Takeda, personal fees from Novartis, personal fees from Glaxo-Smith-Klein, outside the submitted work. JN reports grants from University of Aberdeen and University of Edinburgh during the conduct of the study; and Membership of the following NIHR boards: CPR decision making committee; HTA Commissioning Board; HTA Commissioning Sub-Board (EOI); HTA Funding Boards Policy Group; HTA General Board; HTA Post-Board funding teleconference; NIHR CTU Standing Advisory Committee; NIHR HTA & EME Editorial Board; Pre-exposure Prophylaxis Impact Review Panel. ST has received grant funding from NIHR, other government and charity organisations. He provides commercial consultancy advice which has received financial compensation.

Background: Global crises inevitably increase levels of anxiety in postpartum populations. Effective and efficient measurement is therefore essential. This study aimed to create a 12-item research short form of the 51-item Postpartum Specific Anxiety Scale [PSAS] and validate it for use in rapid response research at a time of global crises [PSAS-RSF-C]. We also present the same 12-items, in five other languages (Italian, French, Chinese, Spanish, Dutch) to increase global accessibility of a psychometric tool to assess maternal mental health., Methods: Twelve items from the PSAS were selected on the basis of a review of their factor loadings. An on-line sample of UK mothers (N = 710) of infants up to 12 weeks old completed the PSAS-RSF-C during COVID-19 'lockdown'., Results: Principal component analyses on a randomly split sample (n = 344) revealed four factors, identical in nature to the original PSAS, which in combination explained 75% of the total variance. Confirmatory factor analyses (n = 366) demonstrated the four-factor model fit the data well. Reliability of the overall scale and of the underlying factors in both samples proved excellent., Conclusions: Findings suggest the PSAS-RSF-C may prove useful as a clinical screening tool and is the first postpartum-specific psychometric scale to be validated during the COVID-19 pandemic. This offers psychometrically sound assessment of postpartum anxiety. By increasing the accessibility of the PSAS, we aim to enable researchers the opportunity to measure maternal anxiety, rapidly, at times of global crisis.

Background: Emergency contraception (EC) was approved in the UK as a pharmacy medicine for purchase without prescription in 2001. Twenty years later we conducted a study to characterise routine practice pharmacy provision of EC., Study Design: Mystery shopper study of 30 pharmacies in Edinburgh, Dundee and London participating in a clinical trial of contraception after EC., Methods: Mystery shoppers, aged ≥16 years, followed a standard scenario requesting EC. After the pharmacy visit, they completed a proforma recording the duration of the consultation, where it took place, and whether advice was given to them about the importance of ongoing contraception after EC., Results: Fifty-five mystery shopper visits were conducted. The median reported duration of the consultation with the pharmacist was 6 (range 1-18) min. Consultations took place in a private room in 34 cases (62%) and at the shop counter in the remainder. In 27 cases (49%) women received advice about ongoing contraception. Eleven women (20%) left the pharmacy without EC due to lack of supplies or of a trained pharmacist. Most women were generally positive about the consultation., Conclusions: While availability of EC from UK pharmacies has undoubtedly improved access, the necessity to have a consultation, however helpful, with a pharmacist introduces delays and around one in five of our mystery shoppers left without getting EC. Consultations in private are not always possible and little advice is given about ongoing contraception. It is time to make EC available without a pharmacy consultation., Competing Interests: Competing interests: AG is a member of HRA Pharma scientific advisory board. PB is a Clinical Director of the not-for profit community interest company SH:24 that provides online sexual health services in partnership with the NHS. AR is in receipt of research grants, educational grants and consultancy with Gilead, research grants from Roche and BMS, and educational grants from Abbvie. JN is Deputy Chair of the NIHR/HTA General Board Committee. NIHR/HTA funded this research., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception., Methods: We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 μg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete)., Findings: Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred., Interpretation: Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception., Funding: National Institute for Health Research (Health Technology Assessment Programme project 15/113/01)., (Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Rationale: Growth and development during adolescence may modify the respiratory and vascular differences seen among extremely preterm (EP) individuals in childhood and early adolescence. Objectives: To assess the trajectory of respiratory and cardiovascular outcomes during transition to adulthood in a national longitudinal cohort study of births before 26 weeks of gestation in the United Kingdom and Ireland. Methods: A total of 129 EP participants and 65 control subjects attended for a center-based evaluation at 19 years of age. Standardized measures of spirometry, hemodynamics, functional capacity, and markers of inflammation were obtained from EP subjects with and without neonatal bronchopulmonary dysplasia and term-born control subjects at 19 years of age and compared with previous assessments. Measurements and Main Results: Compared with the control group, the EP group was significantly impaired on all spirometric parameters (mean FEV 1 z -score, -1.08 SD [95% confidence interval, -1.40 to -0.77]) and had lower fractional exhaled nitric oxide concentrations (13.9 vs. 24.4 ppb; P  < 0.001) despite a higher proportion with bronchodilator reversibility (27% vs. 6%). The EP group had significantly impaired exercise capacity. All respiratory parameters were worse after neonatal bronchopulmonary dysplasia, and respiratory function differences were similar at 11 and 19 years. The augmentation index was 6% higher in the EP group and associated with increased total peripheral resistance (difference in means, 96.4 [95% confidence interval, 26.6-166.2] dyne/s/cm -5 ) and elevation in central, but not peripheral, blood pressure. Central systolic and diastolic blood pressures increased more quickly during adolescence in the EP group than in the control group. Conclusions: Clinicians should address both cardiovascular and respiratory risks in adult survivors of extremely preterm birth.

Post-partum haemorrhage (PPH) is the second greatest direct cause of maternal death in the United Kingdom, and rates of PPH continue to increase despite advances in clinical care. Training workers to manage PPH involves improvement of technical and non-technical skills in the context of a multidisciplinary team (MDT). Management of PPH should begin in the antenatal period, with identification of high-risk women and referral for multispecialty input. Training for the acute management of PPH should involve all members of the labour ward team and beyond, including haematology and non-clinical staff. Simulation-based training, didactic teaching and hybrid obstetric emergency courses are current options for training workers. Non-technical skills should also be taught, including specific training on communication, leadership, situational awareness and team-working skills. Improving management of obstetric emergencies requires thorough antenatal and intra-partum risk assessment, optimising knowledge and non-technical skills of individual members of the team, improving collaboration of the MDT, better simulation training and adjusting local infrastructure., (Copyright © 2019. Published by Elsevier Ltd.)

Background: Echoing international trends, the most recent United Kingdom reports of infant and maternal mortality found that pregnancies to women with social risk factors are over 50% more likely to end in stillbirth or neonatal death and carry an increased risk of premature birth and maternal death. The aim of this realist synthesis was to uncover the mechanisms that affect women's experiences of maternity care., Methods: Using realist methodology, 22 papers exploring how women with a wide range of social risk factors experience maternity care in the United Kingdom were included. The data extraction process identified contexts (C), mechanisms (M), and outcomes (0)., Results: Three themes, Resources, Relationships, and Candidacy, overarched eight CMO configurations. Access to services, appropriate education, interpreters, practical support, and continuity of care were particularly relevant for women who are unfamiliar with the United Kingdom system and those living chaotic lives. For women with experience of trauma, or those who lack a sense of control, a trusting relationship with a health care professional was key to regaining trust. Many women who have social care involvement during their pregnancy perceive health care services as a system of surveillance rather than support, impacting on their engagement. This, as well as experiences of paternalistic care and discrimination, could be mitigated through the ability to develop trusting relationships., Conclusions: The findings provide underlying theory and practical guidance on how to develop safe services that aim to reduce inequalities in women's experiences and birth outcomes., (© 2019 The Authors. Birth published by Wiley Periodicals, Inc.)

Introduction and Hypothesis: To assess trends in the surgical management of pelvic organ prolapse (POP) amongst UK practitioners and changes in practice since a previous similar survey., Methods: An online questionnaire survey (Typeform Pro) was emailed to British Society of Urogynaecology (BSUG) members. They included urogynaecologists working in tertiary centres, gynaecologists with a designated special interest in urogynaecology and general gynaecologists. The questionnaire included case scenarios encompassing contentious issues in the surgical management of POP and was a revised version of the questionnaire used in the previous surveys. The revised questionnaire included additional questions relating to the use of vaginal mesh and laparoscopic urogynaecology procedures., Results: Of 516 BSUG members emailed, 212 provided completed responses.. For anterior vaginal wall prolapse the procedure of choice was anterior colporrhaphy (92% of respondents). For uterovaginal prolapse the procedure of choice was still vaginal hysterectomy and repair (75%). For posterior vaginal wall prolapse the procedure of choice was posterior colporrhaphy with midline fascial plication (97%). For vault prolapse the procedure of choice was sacrocolpopexy (54%) followed by vaginal wall repair and sacrospinous fixation (41%). The laparoscopic route was preferred for sacrocolpopexy (62% versus 38% for the open procedure). For primary prolapse, vaginal mesh was used by only 1% of respondents in the anterior compartment and by 3% in the posterior compartment., Conclusion: Basic trends in the use of native tissue prolapse surgery remain unchanged. There has been a significant decrease in the use of vaginal mesh for both primary and recurrent prolapse, with increasing use of laparoscopic procedures for prolapse.

Purpose To establish the performance of screening with serum cancer antigen 125 (CA-125), interpreted using the risk of ovarian cancer algorithm (ROCA), and transvaginal sonography (TVS) for women at high risk of ovarian cancer (OC) or fallopian tube cancer (FTC). Patients and Methods Women whose estimated lifetime risk of OC/FTC was ≥ 10% were recruited at 42 centers in the United Kingdom and underwent ROCA screening every 4 months. TVS occurred annually if ROCA results were normal or within 2 months of an abnormal ROCA result. Risk-reducing salpingo-oophorectomy (RRSO) was encouraged throughout the study. Participants were observed via cancer registries, questionnaires, and notification by centers. Performance was calculated after censoring 365 days after prior screen, with modeling of occult cancers detected at RRSO. Results Between June 14, 2007, and May 15, 2012, 4,348 women underwent 13,728 women-years of screening. The median follow-up time was 4.8 years. Nineteen patients were diagnosed with invasive OC/FTC within 1 year of prior screening (13 diagnoses were screen-detected and six were occult at RRSO). No symptomatic interval cancers occurred. Ten (52.6%) of the total 19 diagnoses were stage I to II OC/FTC (CI, 28.9% to 75.6%). Of the 13 screen-detected cancers, five (38.5%) were stage I to II (CI, 13.9% to 68.4%). Of the six occult cancers, five (83.3%) were stage I to II (CI, 35.9% to 99.6%). Modeled sensitivity, positive predictive value, and negative predictive value for OC/FTC detection within 1 year were 94.7% (CI, 74.0% to 99.9%), 10.8% (6.5% to 16.5%), and 100% (CI, 100% to 100%), respectively. Seven (36.8%) of the 19 cancers diagnosed < 1 year after prior screen were stage IIIb to IV (CI, 16.3% to 61.6%) compared with 17 (94.4%) of 18 cancers diagnosed > 1 year after screening ended (CI, 72.7% to 99.9%; P < .001). Eighteen (94.8%) of 19 cancers diagnosed < 1 year after prior screen had zero residual disease (with lower surgical complexity, P = .16) (CI, 74.0% to 99.9%) compared with 13 (72.2%) of 18 cancers subsequently diagnosed (CI, 46.5% to 90.3%; P = .09). Conclusion ROCA-based screening is an option for women at high risk of OC/FTC who defer or decline RRSO, given its high sensitivity and significant stage shift. However, it remains unknown whether this strategy would improve survival in screened high-risk women.

At present the clinical management of intersex is in turmoil. The policy of non-disclosure of diagnosis is widespread and cosmetic genital surgery is routinely performed on infants throughout the world. Some clinicians feel such practices are in the interest of the intersex child and the family, but some intersex adults are calling for a moratorium on sex assignment genital surgery. These widely opposing views have led to distrust between groups. One way to begin to address these critical issues is to facilitate dialogue with equal input from clinicians and intersex people and families. Clinicians are experts by training, but patients and families are experts through lived experiences. Our paper reports the rationale, process and outcome of the first UK forum bringing together these different experts to address some of the most complex issues in clinical services. In communicating our experiences, we hope that it will provide a useful reference point for those seeking similar service-user/provider collaboration in other areas of medicine.