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Reference charts for first-trimester placental volume derived using OxNNet.
OBJECTIVE: To establish a comprehensive reference range for OxNNet-derived first-trimester placental volume (FTPV), based on values observed in healthy pregnancies. METHODS: Data were obtained from the First Trimester Placental Ultrasound Study, an observational cohort study in which three-dimensional placental ultrasound imaging was performed between 11 + 2 and 14 + 1 weeks' gestation, alongside otherwise routine care. A subgroup of singleton pregnancies resulting in term live birth, without neonatal unit admission or major chromosomal or structural abnormality, were included. Exclusion criteria were fetal growth restriction, maternal diabetes mellitus, hypertensive disorders of pregnancy or other maternal medical conditions (e.g. chronic hypertension, antiphospholipid syndrome, systemic lupus erythematosus). Placental images were processed using the OxNNet toolkit, a software solution based on a fully convolutional neural network, for automated placental segmentation and volume calculation. Quantile regression and the lambda-mu-sigma (LMS) method were applied to model the distribution of FTPV, using both crown-rump length (CRL) and gestational age as predictors. Model fit was assessed using the Akaike information criterion (AIC), and centile curves were constructed for visual inspection. RESULTS: The cohort comprised 2547 cases. The distribution of FTPV across gestational ages was positively skewed, with variation in the distribution at different gestational timepoints. In model comparisons, the LMS method yielded lower AIC values compared with quantile regression models. For predicting FTPV from CRL, the LMS model with the Sinh-Arcsinh distribution achieved the best performance, with the lowest AIC value. For gestational-age-based prediction, the LMS model with the Box-Cox Cole and Green original distribution achieved the lowest AIC value. The LMS models were selected to construct centile charts for FTPV based on both CRL and gestational age. Evaluation of the centile charts revealed strong agreement between predicted and observed centiles, with minimal deviations. Both models demonstrated excellent calibration, and the Z-scores derived using each of the models confirmed normal distribution. CONCLUSIONS: This study established reference ranges for FTPV based on both CRL and gestational age in healthy pregnancies. The LMS method provided the best model fit, demonstrating excellent calibration and minimal deviations between predicted and observed centiles. These findings should facilitate the exploration of FTPV as a potential biomarker for adverse pregnancy outcome and provide a foundation for future research into its clinical applications. © 2025 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Time Series Methods to Assess the Impact of Regulatory Action: A Study of UK Primary Care and Hospital Data on the Use of Fluoroquinolones.
PURPOSE: To illustrate the interest in using interrupted time series (ITS) methods, this study evaluated the impact of the UK MHRA's March 2019 Risk Minimisation Measures (RMM) on fluoroquinolone usage. METHODS: Monthly and quarterly fluoroquinolone use incidence rates from 2012 to 2022 were analysed across hospital care (Barts Health NHS Trust), primary care (Clinical Practice Research Datalink (CPRD) Aurum and CPRD GOLD), and linked records from both settings (East Scotland). Rates were stratified by age (19-59 and ≥ 60 years old). Seasonality-adjusted segmented regression and ARIMA models were employed to model quarterly and monthly rates, respectively. RESULTS: Post-RMM, with segmented regression, both age groups in Barts Health experienced nearly complete reductions (> 99%); CPRD Aurum saw 20.19% (19-59) and 19.29% ( ≥ $$ \ge $$ 60) reductions; no significant changes in CPRD GOLD; East Scotland had 45.43% (19-59) and 41.47% ( ≥ $$ \ge $$ 60) decreases. Slope analysis indicated increases for East Scotland (19-59) and both CPRD Aurum groups, but a decrease for CPRD GOLD's ≥ $$ \ge $$ 60; ARIMA detected significant step changes in CPRD GOLD not identified by segmented regression and noted a significant slope increase in Barts Health's 19-59 group. Both models showed no post-modelling autocorrelations across databases, yet Barts Health's residuals were non-normally distributed with non-constant variance. CONCLUSIONS: Both segmented regression and ARIMA confirmed the reduction of fluoroquinolones use after RMM across four different UK primary care and hospital databases. Model diagnostics showed good performance in eliminating residual autocorrelation for both methods. However, diagnostics for hospital databases with low incident use revealed the presence of heteroscedasticity and non-normal white noise using both methods.
Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study.
PURPOSE: High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible. MATERIALS AND METHODS: We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in Bacillus Calmette-Guerin-naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned. RESULTS: We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months. CONCLUSION: A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL.
Organochlorine pesticide exposure and risk of prostate cancer development and progression: a systematic review
Background: There is an increasing body of evidence linking the exposure of an individual to pesticides such as organochlorine pesticides (OPCs) and an increased risk of developing diseases such as cancer. Exposure to OPCs has been suggested to increase the risk of developing hormone-dependant cancers such as prostate cancer (PCa). However, there is a relative paucity of information about the influence of exposure to these pesticides on the evolution of PCa, including risk of tumour development, progression to metastasis, and disease recurrence following therapy. Methods: We used several databases such as PubMed MEDLINE Database, Web of Science, and Scopus, in order to conduct a systematic review of the available epidemiological data implicating an association between exposure to OCPs and biochemical recurrence (BCR) of PCa. We searched all peer-reviewed articles published up to July 31 st 2020. Pre-defined eligibility criteria for the inclusion of studies were that they be original studies, reviews, previous meta-analyses, or case–control or cohort studies. Results: Agent Orange is the most widely-studied OCP in the context of any possible causal role in the recurrence of PCa following radical prostatectomy, or in the progression to advanced disease. Only two studies didn’t demonstrate a significant association between exposure to OCPs and subsequent BCR following radical prostatectomy. Another study identified a significant association between exposure to Oxychlordane and PCB44 and progression to advanced PCa. Conclusion: This review confirmed a relative lack of high-quality evidence regarding this topic. However, the available evidence to date suggests the presence of a potential causal relationship between exposure to OPCs and PCa development and progression.
Multiple novel prostate cancer predisposition loci confirmed by an international study: the PRACTICAL Consortium.
A recent genome-wide association study found that genetic variants on chromosomes 3, 6, 7, 10, 11, 19 and X were associated with prostate cancer risk. We evaluated the most significant single-nucleotide polymorphisms (SNP) in these loci using a worldwide consortium of 13 groups (PRACTICAL). Blood DNA from 7,370 prostate cancer cases and 5,742 male controls was analyzed by genotyping assays. Odds ratios (OR) associated with each genotype were estimated using unconditional logistic regression. Six of the seven SNPs showed clear evidence of association with prostate cancer (P = 0.0007-P = 10(-17)). For each of these six SNPs, the estimated per-allele OR was similar to those previously reported and ranged from 1.12 to 1.29. One SNP on 3p12 (rs2660753) showed a weaker association than previously reported [per-allele OR, 1.08 (95% confidence interval, 1.00-1.16; P = 0.06) versus 1.18 (95% confidence interval, 1.06-1.31)]. The combined risks associated with each pair of SNPs were consistent with a multiplicative risk model. Under this model, and in combination with previously reported SNPs on 8q and 17q, these loci explain 16% of the familial risk of the disease, and men in the top 10% of the risk distribution have a 2.1-fold increased risk relative to general population rates. This study provides strong confirmation of these susceptibility loci in multiple populations and shows that they make an important contribution to prostate cancer risk prediction.
Systemic Lupus Erythematosus With Cardiac Tamponade and Myocardial Edema in the Early Postpartum Period.
BACKGROUND: Pericardial effusions are frequently caused by inflammatory diseases. In cases of serosal inflammation, which often present with concomitant systemic symptoms, cardiac tamponade can occur, requiring emergency drainage. Nevertheless, it is rare for the index presentation of a previously undiagnosed inflammatory disease to be with cardiac tamponade. CASE SUMMARY: We describe a case of a young woman who presented in the postpartum period with cardiac tamponade. Further investigations confirmed that the underlying diagnosis was systemic lupus erythematosus (SLE). DISCUSSION: SLE can be associated with pericardial effusion but rarely causes cardiac tamponade. Herein, we describe a case of an index presentation of SLE in the postpartum period with a large pericardial effusion and tamponade. Cardiac imaging showed myocardial edema, reflective of associated myocarditis. TAKE-HOME MESSAGES: SLE can present in the immediate postpartum period, and acute management of tamponade in this context includes drainage of the effusion and immunosuppressive therapy.
Ductal adenocarcinoma of the prostate: A systematic review and meta-analysis of incidence, presentation, prognosis, and management
Abstract Context Ductal adenocarcinoma (DAC) is relatively rare, but is nonetheless the second most common subtype of prostate cancer. First described in 1967, opinion is still divided regarding its biology, prognosis, and outcome. Objectives To systematically interrogate the literature to clarify the epidemiology, diagnosis, management, progression, and survival statistics of DAC. Materials and methods We conducted a literature search of five medical databases from inception to May 04 2020 according to PRISMA criteria using search terms ?prostate ductal adenocarcinoma? OR ?endometriod adenocarcinoma of prostate? and variations of each. Results Some 114 studies were eligible for inclusion, presenting 2 907 170 prostate cancer cases, of which 5911 were DAC. [Correction added on 16 January 2021 after the first online publication: the preceding statement has been corrected in this current version.] DAC accounts for 0.17% of prostate cancer on meta-analysis (range 0.0837%-13.4%). The majority of DAC cases were admixed with predominant acinar adenocarcinoma (AAC). Median Prostate Specific Antigen at diagnosis ranged from 4.2 to 9.6 ng/mL in the case series. DAC was more likely to present as T3 (RR1.71; 95%CI 1.53-1.91) and T4 (RR7.56; 95%CI 5.19-11.01) stages, with far higher likelihood of metastatic disease (RR4.62; 95%CI 3.84-5.56; all P-values < .0001), compared to AAC. Common first treatments included surgery (radical prostatectomy (RP) or cystoprostatectomy for select cases) or radiotherapy (RT) for localized disease, and hormonal or chemo-therapy for metastatic disease. Few studies compared RP and RT modalities, and those that did present mixed findings, although cancer-specific survival rates seem worse after RP. Biochemical recurrence rates were increased with DAC compared to AAC. Additionally, DAC metastasized to unusual sites, including penile and peritoneal metastases. Where compared, all studies reported worse survival for DAC compared to AAC. Conclusion When drawing conclusions about DAC it is important to note the heterogenous nature of the data. DAC is often diagnosed incidentally post-treatment, perhaps due to lack of a single, universally applied histopathological definition. As such, DAC is likely underreported in clinical practice and the literature. Poorer prognosis and outcomes for DAC compared to AAC merit further research into genetic composition, evolution, diagnosis, and treatment of this surprisingly common prostate cancer sub-type. Patient summary Ductal prostate cancer is a rare but important form of prostate cancer. This review demonstrates that it tends to be more serious at detection and more likely to spread to unusual parts of the body. Overall survival is worse with this type of prostate cancer and urologists need to be aware of the presence of ductal prostate cancer to alter management decisions and follow-up.