Publications
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Horne AW, Tong S, Moakes CA, et al., 2023, Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial, The Lancet, Vol: 401, Pages: 655-663, ISSN: 0140-6736
BACKGROUND: Tubal ectopic pregnancies can cause substantial morbidity or even death. Current treatment is with methotrexate or surgery. Methotrexate treatment fails in approximately 30% of women who subsequently require rescue surgery. Gefitinib, an epidermal growth factor receptor inhibitor, might improve the effects of methotrexate. We assessed the efficacy of oral gefitinib with methotrexate, versus methotrexate alone, to treat tubal ectopic pregnancy. METHODS: We performed a multicentre, randomised, double-blind, placebo-controlled trial across 50 UK hospitals. Participants diagnosed with tubal ectopic pregnancy were administered a single dose of intramuscular methotrexate (50 mg/m2) and randomised (1:1 ratio) to 7 days of additional oral gefitinib (250 mg daily) or placebo. The primary outcome, analysed by intention to treat, was surgical intervention to resolve the ectopic pregnancy. Secondary outcomes included time to resolution of ectopic pregnancy and serious adverse events. This trial is registered at the ISRCTN registry, ISCRTN 67795930. FINDINGS: Between Nov 2, 2016, and Oct 6, 2021, 328 participants were allocated to methotrexate and gefitinib (n=165) or methotrexate and placebo (n=163). Three participants in the placebo group withdrew. Surgical intervention occurred in 50 (30%) of 165 participants in the gefitinib group and in 47 (29%) of 160 participants in the placebo group (adjusted risk ratio 1·15, 95% CI 0·85 to 1·58; adjusted risk difference -0·01, 95% CI -0·10 to 0·09; p=0·37). Without surgical intervention, median time to resolution was 28·0 days in the gefitinib group and 28·0 days in the placebo group (subdistribution hazard ratio 1·03, 95% CI 0·75 to 1·40). Serious adverse events occurred in five (3%) of 165 participants in the gefitinib group and in six (4%) of 162 participants in the placebo group. Diarrhoea and rash were more common in the gefitinib group.
Timmerman S, Valentin L, Ceusters J, et al., 2023, External validation of the ovarian-adnexal reporting and data system (O-RADS) lexicon and the international ovarian tumor analysis 2-step strategy to stratify ovarian tumors into O-RADS risk groups, JAMA Oncology, Vol: 9, Pages: 225-233, ISSN: 2374-2445
IMPORTANCE: Correct diagnosis of ovarian cancer results in better prognosis. Adnexal lesions can be stratified into the Ovarian-Adnexal Reporting and Data System (O-RADS) risk of malignancy categories with either the O-RADS lexicon, proposed by the American College of Radiology, or the International Ovarian Tumor Analysis (IOTA) 2-step strategy. OBJECTIVE: To investigate the diagnostic performance of the O-RADS lexicon and the IOTA 2-step strategy. DESIGN, SETTING, AND PARTICIPANTS: Retrospective external diagnostic validation study based on interim data of IOTA5, a prospective international multicenter cohort study, in 36 oncology referral centers or other types of centers. A total of 8519 consecutive adult patients presenting with an adnexal mass between January 1, 2012, and March 1, 2015, and treated either with surgery or conservatively were included in this diagnostic study. Twenty-five patients were excluded for withdrawal of consent, 2777 were excluded from 19 centers that did not meet predefined data quality criteria, and 812 were excluded because they were already in follow-up at recruitment. The analysis included 4905 patients with a newly detected adnexal mass in 17 centers that met predefined data quality criteria. Data were analyzed from January 31 to March 1, 2022. EXPOSURES: Stratification into O-RADS categories (malignancy risk <1%, 1% to <10%, 10% to <50%, and ≥50%). For the IOTA 2-step strategy, the stratification is based on the individual risk of malignancy calculated with the IOTA 2-step strategy. MAIN OUTCOMES AND MEASURES: Observed prevalence of malignancy in each O-RADS risk category, as well as sensitivity and specificity. The reference standard was the status of the tumor at inclusion, determined by histology or clinical and ultrasonographic follow-up for 1 year. Multiple imputation was used for uncertain outcomes owing to inconclusive follow-up information. RESULTS: Median age of the 4905 patients was 48 years (IQR, 36-62 years
Landolfo C, Bourne T, Froyman W, et al., 2023, Benign descriptors and ADNEX in two-step strategy to estimate risk of malignancy in ovarian tumors: retrospective validation in IOTA5 multicenter cohort, ULTRASOUND IN OBSTETRICS & GYNECOLOGY, ISSN: 0960-7692
Lawson K, Bourne T, Bottomley C, 2022, Psychological impact of simple scoring system for predicting early pregnancy outcome in pregnancy of uncertain viability: randomized controlled trial, Ultrasound in Obstetrics and Gynecology, ISSN: 0960-7692
OBJECTIVE: To explore whether the psychological response in women with an intrauterine pregnancy of uncertain viability can be modified during the waiting period to final diagnosis, by offering predictive information regarding the likely outcome of the pregnancy (chance of ongoing viability). METHODS: A single centre prospective two-arm randomized controlled trial conducted over 18 months at an inner city London teaching hospital. Consecutive eligible women attending the early pregnancy assessment unit with an interim ultrasound finding of intrauterine pregnancy of uncertain viability were recruited. All women were offered a follow-up ultrasound after 14 days. Participants were randomized to receive a prediction score for ongoing viability at 14 days or routine (control) care. Anxiety, depression and worry symptoms were assessed using validated self-report questionnaires prior to randomization and at specific time-points during the waiting period to final diagnosis. The change in psychological scores over the study time period was analysed. Secondary outcomes were the measures of perceived value of the tool reported by the participants. RESULTS: 278 women participated. No difference in the change in anxiety, depression or worry scores was demonstrated between control and intervention groups at any time point. Subgroup analysis first of women with the highest initial anxiety (HADS >11) or worry (>= 45) and second of women with the more favourable predicted prognosis (≥75% chance) showed no difference in the intervention group compared with controls. Despite this 76/110 (69%; 95% CI, 60.5-78.4%) of women who provided feedback in the intervention group reported it to be helpful and 97/110 (88.4%; 95% CI, 81.0-93.7%) reported they would use the tool again. CONCLUSIONS: Current prediction tools may be useful for healthcare professionals to guide management and optimise utilisation of early pregnancy resources. However, implementation of an a
Dawood Y, Buijtendijk MFJ, Shah H, et al., 2022, Imaging fetal anatomy, Seminars in Cell and Developmental Biology, Vol: 131, Pages: 78-92, ISSN: 1084-9521
Due to advancements in ultrasound techniques, the focus of antenatal ultrasound screening is moving towards the first trimester of pregnancy. The early first trimester however remains in part, a 'black box', due to the size of the developing embryo and the limitations of contemporary scanning techniques. Therefore there is a need for images of early anatomical developmental to improve our understanding of this area. By using new imaging techniques, we can not only obtain better images to further our knowledge of early embryonic development, but clear images of embryonic and fetal development can also be used in training for e.g. sonographers and fetal surgeons, or to educate parents expecting a child with a fetal anomaly. The aim of this review is to provide an overview of the past, present and future techniques used to capture images of the developing human embryo and fetus and provide the reader newest insights in upcoming and promising imaging techniques. The reader is taken from the earliest drawings of da Vinci, along the advancements in the fields of in utero ultrasound and MR imaging techniques towards high-resolution ex utero imaging using Micro-CT and ultra-high field MRI. Finally, a future perspective is given about the use of artificial intelligence in ultrasound and new potential imaging techniques such as synchrotron radiation-based CT to increase our knowledge regarding human development.
Verberkt C, Jordans IPM, Van den Bosch T, et al., 2022, How to perform standardized sonographic examination of uterine niche in non-pregnant women, Ultrasound in Obstetrics and Gynecology, Vol: 60, Pages: 420-424, ISSN: 0960-7692
Heremans R, Van Den Bosch T, Valentin L, et al., 2022, Ultrasound features of endometrial pathology in women without abnormal uterine bleeding: results from the International Endometrial Tumor Analysis study (IETA3), ULTRASOUND IN OBSTETRICS & GYNECOLOGY, Vol: 60, Pages: 243-255, ISSN: 0960-7692
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Mullins E, Perry A, Banerjee J, et al., 2022, Pregnancy and neonatal outcomes of COVID-19: The PAN-COVID study., European Journal of Obstetrics Gynecology and Reproductive Biology, Vol: 276, Pages: 161-167, ISSN: 0301-2115
OBJECTIVE: To assess perinatal outcomes for pregnancies affected by suspected or confirmed SARS-CoV-2 infection. METHODS: Prospective, web-based registry. Pregnant women were invited to participate if they had suspected or confirmed SARS-CoV-2 infection between 1st January 2020 and 31st March 2021 to assess the impact of infection on maternal and perinatal outcomes including miscarriage, stillbirth, fetal growth restriction, pre-term birth and transmission to the infant. RESULTS: Between April 2020 and March 2021, the study recruited 8239 participants who had suspected or confirmed SARs-CoV-2 infection episodes in pregnancy between January 2020 and March 2021. Maternal death affected 14/8197 (0.2%) participants, 176/8187 (2.2%) of participants required ventilatory support. Pre-eclampsia affected 389/8189 (4.8%) participants, eclampsia was reported in 40/ 8024 (0.5%) of all participants. Stillbirth affected 35/8187 (0.4 %) participants. In participants delivering within 2 weeks of delivery 21/2686 (0.8 %) were affected by stillbirth compared with 8/4596 (0.2 %) delivering ≥ 2 weeks after infection (95 % CI 0.3-1.0). SGA affected 744/7696 (9.3 %) of livebirths, FGR affected 360/8175 (4.4 %) of all pregnancies. Pre-term birth occurred in 922/8066 (11.5%), the majority of these were indicated pre-term births, 220/7987 (2.8%) participants experienced spontaneous pre-term births. Early neonatal deaths affected 11/8050 livebirths. Of all neonates, 80/7993 (1.0%) tested positive for SARS-CoV-2. CONCLUSIONS: Infection was associated with indicated pre-term birth, most commonly for fetal compromise. The overall proportions of women affected by SGA and FGR were not higher than expected, however there was the proportion affected by stillbirth in participants delivering within 2 weeks of infection was significantly higher than those delivering ≥ 2 weeks after infection. We suggest that clinicians' thresh
Harmsen MJ, van den Bosch T, De Leeuw RA, et al., 2022, Consensus on revised definitions of Morphological Uterus Sonographic Assessment (MUSA) features of adenomyosis: results of modified Delphi procedure, ULTRASOUND IN OBSTETRICS & GYNECOLOGY, Vol: 60, Pages: 118-131, ISSN: 0960-7692
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Kyriacou C, Bourne T, 2022, Comparing ultraviolet with chlorine dioxide wipe system for vaginal ultrasound probe cleaning: critical analysis of the term 'cleaning' Reply, ULTRASOUND IN OBSTETRICS & GYNECOLOGY, Vol: 60, Pages: 147-148, ISSN: 0960-7692
Kyriacou C, Robinson E, Barcroft J, et al., 2022, Comparing time effectiveness and convenience of ultraviolet vaginal ultrasound probe disinfection with chlorine dioxide multistep wipe system: prospective survey study., Ultrasound in Obstetrics and Gynecology, Vol: 60, Pages: 132-138, ISSN: 0960-7692
OBJECTIVES: To compare efficiency, ease of use, and user satisfaction of two methods of transvaginal ultrasound probe high-level disinfection: Ultraviolet (UV-C) (Germitec Hypernova Chronos) and a chlorine dioxide multi-step wipe system (Tristel Trio). METHODS: This was a prospective survey study. UV-C units were introduced into a busy Early Pregnancy Assessment Unit and compared with a multi-wipe system. Healthcare professionals (HCP's) measured time taken to complete a cycle of disinfection before each patient with the system allocated to that room using a stopwatch and recorded their responses using a quick response (QR) code-linked survey. Additional necessary tasks that could be completed before seeing the next patient as probe disinfection was ongoing were also documented. Using another QR code-linked survey, data on ease of use, satisfaction of the system used, and preference was collected. A section for free-text comments was then completed. RESULTS: Disinfection using UV-C (n=331) was 60% faster than the chlorine dioxide multi-wipe system (n=332) (101 vs 250 seconds, p<0.0001). A greater number of tasks during probe disinfection were completed when using UV-C, saving a further 74 seconds per patient (p<0.0001). HCP's using UV-C (n=71) reported greater ease of use (10 vs 3/10, p<0.0001) and satisfaction (10 vs 2/10, p<0.0001) than those using the multi-wipe system (n=43). HCP's reported that the chlorine dioxide system was time-consuming and environmentally unfriendly, whilst the UV-C system was efficient and easy to use. 98% HCP's preferred using the UV-C system. CONCLUSIONS: UV-C technology was more efficient and allowed more essential tasks to be completed during disinfection. For a four-hour ultrasound list of 15 patients, we calculated this would amount to 55 minutes 45 seconds extra time available. HCP's found UV-C preferable and easier to use. This article is protected by copyright. All rights reserved.
Bortoletto P, Lucas ES, Melo P, et al., 2022, Miscarriage syndrome: Linking early pregnancy loss to obstetric and age-related disorders, EBIOMEDICINE, Vol: 81, ISSN: 2352-3964
Wynants L, Verbakel JYJ, Valentin L, et al., 2022, The Risk of Endometrial Malignancy and Other Endometrial Pathology in Women with Abnormal Uterine Bleeding: An Ultrasound-Based Model Development Study by the IETA Group, GYNECOLOGIC AND OBSTETRIC INVESTIGATION, Vol: 87, Pages: 54-61, ISSN: 0378-7346
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Vanderstichele A, Busschaert P, Landolfo C, et al., 2022, Nucleosome footprinting in plasma cell-free DNA for the pre-surgical diagnosis of ovarian cancer, NPJ GENOMIC MEDICINE, Vol: 7
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Jordans IPM, Verberkt C, De Leeuw RA, et al., 2022, Definition and sonographic reporting system for Cesarean scar pregnancy in early gestation: modified Delphi method, Ultrasound in Obstetrics and Gynecology, Vol: 59, Pages: 437-449, ISSN: 0960-7692
ObjectiveTo develop a standardized sonographic evaluation and reporting system for Cesarean scar pregnancy (CSP) in the first trimester, for use by both general gynecology and expert clinics.MethodsA modified Delphi procedure was carried out, in which 28 international experts in obstetric and gynecological ultrasonography were invited to participate. Extensive experience in the use of ultrasound to evaluate Cesarean section (CS) scars in early pregnancy and/or publications concerning CSP or niche evaluation was required to participate. Relevant items for the detection and evaluation of CSP were determined based on the results of a literature search. Consensus was predefined as a level of agreement of at least 70% for each item, and a minimum of three Delphi rounds were planned (two online questionnaires and one group meeting).ResultsSixteen experts participated in the Delphi study and four Delphi rounds were performed. In total, 58 items were determined to be relevant. We differentiated between basic measurements to be performed in general practice and advanced measurements for expert centers or for research purposes. The panel also formulated advice on indications for referral to an expert clinic. Consensus was reached for all 58 items on the definition, terminology, relevant items for evaluation and reporting of CSP. It was recommended that the first CS scar evaluation to determine the location of the pregnancy should be performed at 6–7 weeks' gestation using transvaginal ultrasound. The use of magnetic resonance imaging was not considered to add value in the diagnosis of CSP. A CSP was defined as a pregnancy with implantation in, or in close contact with, the niche. The experts agreed that a CSP can occur only when a niche is present and not in relation to a healed CS scar. Relevant sonographic items to record included gestational sac (GS) size, vascularity, location in relation to the uterine vessels, thickness of the residual myometrium and locati
Farren J, Jalmbrant M, Falconieri N, et al., 2022, Prognostic factors for post-traumatic stress, anxiety and depression in women after early pregnancy loss: a multi-centre prospective cohort study, BMJ Open, Vol: 12, ISSN: 2044-6055
Objectives: To investigate prognostic factors for anxiety, depression and post-traumatic stress symptoms one month after early pregnancy loss (EPL).Design: A prospective cohort study. Consecutive women were recruited, and demographic and clinical data collected. Surveys containing the hospital anxiety and depression scale (HADS) and posttraumatic stress diagnostic scale (PDS) were emailed one month after a loss. Univariable logistic regression was performed to link factors with caseness of anxiety, depression or post-traumatic stress (PTS) according to screening measures.Setting: Early pregnancy units of three central London hospitals.Participants: 737/1116 eligible women with an EPL were recruited. 492 responded to HADS and 487 to PDS.Primary and secondary outcome measures: Primary outcome is the area under the curve (AUC) to predict any psychological morbidity (defined as moderate/severe anxiety or depression, or meeting screening criteria for PTS) for each variable. Further outcomes are explained variation (R-squared) and p-value for any morbidity, and AUC, explained variation, and p-value for each morbidity separately. Results: Women who had a current or past diagnosis of a psychiatric condition were more likely to meet criteria for anxiety, depression or PTS (75% for current versus 55% for past versus 30% for no diagnosis; AUC 0.61; R-squared 8.4%; p<0.0001), as were those with previous pregnancy loss (48% versus 30%; AUC 0.59; R-squared 4.3%; p<0.0001). Most of the assessed factors did not demonstrate potential utility in predicting psychological distress, including gestational age, overnight admission, time taken for diagnosis, pre-existing children, and the diagnosis itself (miscarriage versus ectopic versus other) (AUCs≤0.54; R-squared≤0.9%). Conclusions: Women with a history of mental health problems, or those with previous losses, may be at higher risk of psychological illness one month after pregnancy loss. However, prognostic ability was po
Salvesen K, Ter Haar G, Miloro P, et al., 2022, ISUOG Safety Committee updated recommendation on use of respirators by practitioners undertaking obstetric and gynecological ultrasound in context of SARS-CoV-2 Omicron variant of concern, Ultrasound in Obstetrics and Gynecology, Vol: 59, Pages: 411-411, ISSN: 0960-7692
Verbakel JY, Heremans R, Wynants L, et al., 2022, Risk assessment for endometrial cancer in women with abnormal vaginal bleeding: Results from the prospective IETA-1 cohort study, INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS, Vol: 159, Pages: 103-110, ISSN: 0020-7292
Bourne T, Kyriacou C, Shah H, et al., 2022, The experiences and wellbeing of healthcare professionals working in the field of ultrasound in Obstetrics and Gynecology as the SARS-CoV-2 pandemic was evolving: a cross-sectional survey study, BMJ Open, Vol: 12, Pages: 1-12, ISSN: 2044-6055
Objectives: Assess experience of healthcare professionals (HCPs) working with ultrasound in Obstetrics and Gynecology during the evolving SARS-CoV-2 pandemic given the new and unprecedented challenges involving viral exposure, personal protective equipment (PPE) and wellbeing.Design: Prospective cross-sectional survey study.Setting: Online international survey. Single-best, open box and Hospital and Anxiety Depression Scale (HADS) questions.Participants: The survey was sent to 35,509 HCPs in 124 countries and was open from 7th-21st May 2020. 2237/3237 (69.1%) HCPs from 115 countries who consented to participate completed the survey. 1058 (47.3%) completed the HADS. Primary outcome measures: Overall prevalence of SARS-CoV-2, depression and anxiety amongst HCPs in relation to country and PPE availability.Analyses: Univariate analyses were used to investigate associations without generating erroneous causal conclusions.Results: Confirmed/suspected SARS-CoV-2 prevalence was 13.0%. PPE provision concerns were raised by 74.1% of participants; highest amongst trainees/resident physicians (83.9%), and amongst HCPs in Spain (89.7%). Most participants worked in self-perceived high-risk areas for SARS-CoV-2 (67.5-87.0%), with proportionately more trainees interacting with suspected/confirmed infected patients (57.1% versus 24.2-40.6%) and sonographers seeing more patients who did not wear a mask (33.3% versus 13.9-7.9%). The most frequent PPE combination used were gloves and a surgical mask (22.3%). UK and US respondents reported spending less time self-isolating (8.8 days) and lower satisfaction with their national pandemic response (37.0-43.0%). 19.8% and 8.8% of respondents met the criteria for moderate to severe anxiety and depression respectively. Conclusions: Reported SARS-CoV-2 HCP prevalence is consistent with literature findings. Most respondents used gloves and a surgical mask, with a greater SARS-CoV-2 prevalence compared with those using ‘full’ PPE. HCP
Grewal K, Lee Y, Smith A, et al., 2022, Chromosomally normal miscarriage is associated with vaginal dysbiosis and local inflammation, BMC Medicine, Vol: 20, ISSN: 1741-7015
BackgroundEmerging evidence supports an association between vaginal microbiota composition and risk of miscarriage, however the underlying mechanisms are poorly understood. We aim to investigate the vaginal microbial composition and the local immune response in chromosomally normal and abnormal miscarriages and compare this to uncomplicated pregnancies delivering at term.Methods We used 16S rRNA gene based metataxonomics to interrogate the vaginal microbiota in a cohort of 167 women, 93 miscarriages (54 euploid and 39 aneuploid using molecular cytogenetics) and 74 women who delivered at term and correlate this with the aneuploidy status of the miscarriages. We also measured the concentrations of IL-2, IL-4, IL-6, IL-8, TNF-α, IFN-γ, IL-1β, IL-18 and IL-10 in cervical vaginal fluid.Results We show that euploid miscarriage is associated with a significantly higher prevalence of Lactobacillus spp. deplete vaginal microbial communities compared to aneuploid miscarriage (P=0.01). Integration of matched cervicovaginal fluid immune-profiles showed that Lactobacillus spp. depleted vaginal microbiota associated with pro-inflammatory cytokine levels most strongly in euploid miscarriage compared to viable term pregnancy (IL-1β; P<0.001, IL-8; P=0.01, IL-6; P<0.001). ConclusionOur data suggest the vaginal microbiota plays an important aetiological role in euploid miscarriage and may represent a target to modify risk of pregnancy loss.
Kasaven LS, Saso S, Ben Nagi J, et al., 2022, TOGadvisor: the role of online feedback in obstetrics and gynaecology, OBSTETRICIAN & GYNAECOLOGIST, Vol: 24, Pages: 7-11, ISSN: 1467-2561
Phylactou M, Abbara A, Al-Memar M, et al., 2022, Changes in circulating kisspeptin levels during each trimester in women with antenatal complications, Journal of Clinical Endocrinology and Metabolism, Vol: 107, Pages: e71-e83, ISSN: 0021-972X
ContextAntenatal complications such as hypertensive disorders of pregnancy (HDP), fetal growth restriction (FGR), gestational diabetes (GDM), and preterm birth (PTB) are associated with placental dysfunction. Kisspeptin has emerged as a putative marker of placental function, but limited data exist describing circulating kisspeptin levels across all three trimesters in women with antenatal complications.ObjectiveTo assess whether kisspeptin levels are altered in women with antenatal complications.DesignWomen with antenatal complications (n=105) and those with uncomplicated pregnancies (n=265) underwent serial ultrasound scans and blood-sampling at least once during each trimester (March 2014 to March 2017).SettingEarly Pregnancy Assessment Unit at Hammersmith Hospital, UK.ParticipantsWomen with antenatal complications: HDP (n=32), FGR (n=17), GDM (n=35) and PTB (n=11), and 10 women with multiple complications, provided 373 blood samples, and a further 265 controls provided 930 samples.Main outcomeDifferences in circulating kisspeptin levels.ResultsThird trimester kisspeptin levels were higher than controls in HDP but lower in FGR. The odds of HDP adjusted for gestational age, maternal age, ethnicity, BMI, smoking and parity were increased by 30% (95%CI 16-47%; p<0.0001), and of FGR were reduced by 28% (95%CI 4-46%; p=0.025), for every 1 nmol/L increase in plasma kisspeptin. Multiple of gestation-specific median values of kisspeptin were higher in pregnancies affected by PTB (p=0.014), and lower in those affected by GDM (p=0.020), but not significantly on multivariable analysis.ConclusionWe delineate changes in circulating kisspeptin levels at different trimesters and evaluate the potential of kisspeptin as a biomarker for antenatal complications.
Naji O, Souter V, Mullins E, et al., 2022, The blind spot: value‐based health care in obstetrics and gynaecology, The Obstetrician & Gynaecologist, Vol: 24, Pages: 67-72, ISSN: 1467-2561
Key contentContinuing financial constraints on the UK’s National Health Service means the need for clinicians to provide high-quality care in a cost-effective way has never been greater.While the medical education system equips doctors with skills to provide safe clinical care, it should also provide an understanding of healthcare costs and cost-effectiveness analysis.Value-based care is becoming a key paradigm in women’s health services, where clinicians must employ strategies for delivering value, rationalising costs and capitalising on the use of emerging technologies.The calculation of value of an intervention for providers and service users may differ; care must be taken to ensure this concept is adapted for, and not imposed on healthcare systems.Engaging trainees in systems transformation and embedding the concepts of ‘do no financial harm’ are essential to ensure sustainable healthcare services.Learning ObjectivesTo understand the principles of value-based health care.To highlight the importance of adopting ‘cost-conscious’ care within daily clinical practice.To learn the differences between ‘cost’, ‘charge’, ‘price’ and ‘reimbursement.To encourage developing value-based competencies for future medical workforce through utilising out of programme placements and digital resources.Ethical IssuesThe ethical obligation of clinicians to consider cost may encompass justice and equity. However, the impact of practicing value-based health care is yet to be evaluated.
Kyriacou C, Cooper N, Robinson E, et al., 2021, Ultrasound characteristics, serum biochemistry and outcomes for ectopic pregnancies presenting during the SARS-CoV-2 pandemic: retrospective analysis, Ultrasound in Obstetrics and Gynecology, Vol: 58, Pages: 909-915, ISSN: 0960-7692
OBJECTIVES: To describe and then compare the characteristics of ectopic pregnancies (EP) in the year prior to and then during the SARS-CoV-2 pandemic. METHODS: This was a retrospective analysis from 1st January 2019 to 31st December 2020 of women diagnosed with an EP (n=275) at a London dual center early pregnancy assessment service. Women were identified via the AstraiaTM ultrasound reporting system using coded and non-coded outcomes of 'EP' or 'pregnancy outside the uterine cavity'. Data relating to predefined outcomes were collected using AstraiaTM and CernerTM electronic reporting systems. Main outcome measures included clinical, ultrasound and biochemical features of EP, in addition to reported complications and management. Statistical analysis was carried out using GraphPad Prism v8.2.1. RESULTS: Similar numbers and proportions of EP were seen in 2019 (n=141, 1%) and 2020 (n=134, 1%). Both cohorts were comparable in age, ethnicity, weight and method of conception. Gestational age at first ultrasound and at diagnosis was similar, with no difference in EP location, size or morphology. Human chorionic gonadotrophin (hCG) levels at time of EP diagnosis were higher in 2020 than 2019 (1005 IU/L vs 665 IU/L, p=0.03). The type of final EP management was similar, but more failed first line management during the pandemic (16% vs 6%, p=0.01). Rates of blood visualized on ultrasound within the pelvis (hemoperitoneum) (23% vs 27%, p=0.58) and of rupture confirmed surgically (9% vs 3%, p=0.07) were both similar. CONCLUSIONS: No difference was observed in the location, size, morphology and gestational age of ectopic pregnancies. Complication rates and management were also unchanged. HCG levels were higher, and a greater proportion of conservative management measures failed during the pandemic. Our findings suggest women continued to access appropriate care for EP during the SARS-CoV-2 pandemic, with no evidence of diagnostic delay or increase in adverse outcomes in our popul
Bobdiwala S, Kyriacou C, Christodoulou E, et al., 2021, Evaluating cut-off levels for progesterone, beta human chorionic gonadotropin and beta human chorionic gonadotropin ratio to exclude pregnancy viability in women with a pregnancy of unknown location: A prospective multicenter cohort study, Acta Obstetricia et Gynecologica Scandinavica, Vol: 101, Pages: 46-55, ISSN: 0001-6349
IntroductionThere is no global agreement on how to best determine pregnancy of unknown location viability and location using biomarkers. Measurements of progesterone and β human chorionic gonadotropin (βhCG) are still used in clinical practice to exclude the possibility of a viable intrauterine pregnancy (VIUP). We evaluate the predictive value of progesterone, βhCG, and βhCG ratio cut-off levels to exclude a VIUP in women with a pregnancy of unknown location.Material and methodsThis was a secondary analysis of prospective multicenter study data of consecutive women with a pregnancy of unknown location between January 2015 and 2017 collected from dedicated early pregnancy assessment units of eight hospitals. Single progesterone and serial βhCG measurements were taken. Women were followed up until final pregnancy outcome between 11 and 14 weeks of gestation was confirmed using transvaginal ultrasonography: (1) VIUP, (2) non-viable intrauterine pregnancy or failed pregnancy of unknown location, and (3) ectopic pregnancy or persisting pregnancy of unknown location. The predictive value of cut-off levels for ruling out VIUP were evaluated across a range of values likely to be encountered clinically for progesterone, βhCG, and βhCG ratio.ResultsData from 2507 of 3272 (76.6%) women were suitable for analysis. All had data for βhCG levels, 2248 (89.7%) had progesterone levels, and 1809 (72.2%) had βhCG ratio. The likelihood of viability falls with the progesterone level. Although the median progesterone level associated with viability was 59 nmol/L, VIUP were identified with levels as low as 5 nmol/L. No single βhCG cut-off reliably ruled out the presence of viability with certainty, even when the level was more than 3000 IU/L, there were 39/358 (11%) women who had a VIUP. The probability of viability decreases with the βhCG ratio. Although the median βhCG ratio associated with viability was 2.26, VIUP were identi
Vaulet T, Al-Memar M, Fourie H, et al., 2021, Gradient boosted trees with individual explanations: An alternative to logistic regression for viability prediction in the first trimester of pregnancy, COMPUTER METHODS AND PROGRAMS IN BIOMEDICINE, Vol: 213, ISSN: 0169-2607
Sprooten J, Vankerckhoven A, Vanmeerbeek I, et al., 2021, Peripherally-driven myeloid NFkB and IFN/ISG responses predict malignancy risk, survival, and immunotherapy regime in ovarian cancer, Journal for ImmunoTherapy of Cancer, Vol: 9, Pages: 1-18, ISSN: 2051-1426
Background Tumors can influence peripheral immune macroenvironment, thereby creating opportunities for non-invasive serum/plasma immunobiomarkers for immunostratification and immunotherapy designing. However, current approaches for immunobiomarkers’ detection are largely quantitative, which is unreliable for assessing functional peripheral immunodynamics of patients with cancer. Hence, we aimed to design a functional biomarker modality for capturing peripheral immune signaling in patients with cancer for reliable immunostratification.Methods We used a data-driven in silico framework, integrating existing tumor/blood bulk-RNAseq or single-cell (sc)RNAseq datasets of patients with cancer, to inform the design of an innovative serum-screening modality, that is, serum-functional immunodynamic status (sFIS) assay. Next, we pursued proof-of-concept analyses via multiparametric serum profiling of patients with ovarian cancer (OV) with sFIS assay combined with Luminex (cytokines/soluble immune checkpoints), CA125-antigen detection, and whole-blood immune cell counts. Here, sFIS assay’s ability to determine survival benefit or malignancy risk was validated in a discovery (n=32) and/or validation (n=699) patient cohorts. Lastly, we used an orthotopic murine metastatic OV model, with anti-OV therapy selection via in silico drug–target screening and murine serum screening via sFIS assay, to assess suitable in vivo immunotherapy options.Results In silico data-driven framework predicted that peripheral immunodynamics of patients with cancer might be best captured via analyzing myeloid nuclear factor kappa-light-chain enhancer of activated B cells (NFκB) signaling and interferon-stimulated genes' (ISG) responses. This helped in conceptualization of an ‘in sitro’ (in vitro+in situ) sFIS assay, where human myeloid cells were exposed to patients’ serum in vitro, to assess serum-induced (si)-NFκB or interferon (IFN)/ISG responses (as act
Van Calster B, Bourne T, Froyman W, et al., 2021, Re: "Diagnostic Accuracies of the Ultrasound and Magnetic Resonance Imaging ADNEX Scoring Systems for Ovarian Adnexal Mass: Systematic Review and Meta-Analysis", ACADEMIC RADIOLOGY, Vol: 28, Pages: 1643-1644, ISSN: 1076-6332
Timmerman D, Cibula D, Planchamp F, et al., 2021, Response to: Correspondence on "ESGO/ISUOG/IOTA/ESGE Consensus Statement on pre-operative diagnosis of ovarian tumors" by Thomassin-Nagarra et al, INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, Vol: 31, Pages: 1396-1397, ISSN: 1048-891X
Phylactou M, Abbara A, Al-Memar M, et al., 2021, Performance of plasma kisspeptin as a biomarker for miscarriage improves with gestation during the first trimester, Fertility and Sterility, Vol: 116, Pages: 809-819, ISSN: 0015-0282
ObjectiveTo compare the performance of kisspeptin and beta human chorionic gonadotropin (βhCG), both alone and in combination, as biomarkers for miscarriage throughout the first trimester.DesignProspective, nested case-control study.SettingTertiary Centre, Queen Charlotte Hospital, London, United Kingdom.Patient(s)Adult women who had miscarriages (n = 95, 173 samples) and women with healthy pregnancies (n = 265, 557 samples).Intervention(s)The participants underwent serial ultrasound scans and blood sampling for measurement of plasma kisspeptin and βhCG levels during the first trimester.Main Outcome Measure(s)The ability of plasma kisspeptin and βhCG levels to distinguish pregnancies complicated by miscarriage from healthy pregnancies unaffected by miscarriage.Result(s)Gestation-adjusted levels of circulating kisspeptin and βhCG were lower in samples from women with miscarriages than in women with healthy pregnancies by 79% and 70%, respectively. The area under the receiver-operating characteristic curve for identifying miscarriage during the first trimester was 0.874 (95% confidence interval [CI] 0.844–0.904) for kisspeptin, 0.859 (95% CI 0.820–0.899) for βhCG, and 0.916 (95% CI 0.886–0.946) for the sum of the two markers. The performance of kisspeptin in identifying miscarriage improved with increasing length of gestation, whereas that of βhCG worsened. A decision matrix incorporating kisspeptin, βhCG, and gestational age had 83% to 87% accuracy for the prediction of miscarriage.Conclusion(s)Plasma kisspeptin is a promising biomarker for miscarriage and provides additional value to βhCG alone, especially during later gestational weeks of the first trimester.
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