To evaluate the utility of preoperative diagnostic models for ovarian cancer based on ultrasound and/or biomarkers for referring patients to specialized oncology care. The investigated models were ...RMI, ROMA, and 3 models from the International Ovarian Tumor Analysis (IOTA) group LR2, ADNEX, and the Simple Rules risk score (SRRisk).
A secondary analysis of prospectively collected data from 2 cross-sectional cohort studies was performed to externally validate diagnostic models. A total of 2,763 patients (2,403 in dataset 1 and 360 in dataset 2) from 18 centers (11 oncology centers and 7 nononcology hospitals) in 6 countries participated. Excised tissue was histologically classified as benign or malignant. The clinical utility of the preoperative diagnostic models was assessed with net benefit (NB) at a range of risk thresholds (5%-50% risk of malignancy) to refer patients to specialized oncology care. We visualized results with decision curves and generated bootstrap confidence intervals.
The prevalence of malignancy was 41% in dataset 1 and 40% in dataset 2. For thresholds up to 10% to 15%, RMI and ROMA had a lower NB than referring all patients. SRRisks and ADNEX demonstrated the highest NB. At a threshold of 20%, the NBs of ADNEX, SRrisks, and RMI were 0.348, 0.350, and 0.270, respectively. Results by menopausal status and type of center (oncology vs. nononcology) were similar.
All tested IOTA methods, especially ADNEX and SRRisks, are clinically more useful than RMI and ROMA to select patients with adnexal masses for specialized oncology care.
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Ovarian tumours are usually surgically removed because of the presumed risk of complications. Few large prospective studies on long-term follow-up of adnexal masses exist. We aimed to estimate the ...cumulative incidence of cyst complications and malignancy during the first 2 years of follow-up after adnexal masses have been classified as benign by use of ultrasonography.
In the international, prospective, cohort International Ovarian Tumor Analysis Phase 5 (IOTA5) study, patients aged 18 years or older with at least one adnexal mass who had been selected for surgery or conservative management after ultrasound assessment were recruited consecutively from 36 cancer and non-cancer centres in 14 countries. Follow-up of patients managed conservatively is ongoing at present. In this 2-year interim analysis, we analysed patients who were selected for conservative management of an adnexal mass judged to be benign on ultrasound on the basis of subjective assessment of ultrasound images. Conservative management included ultrasound and clinical follow-up at intervals of 3 months and 6 months, and then every 12 months thereafter. The main outcomes of this 2-year interim analysis were cumulative incidence of spontaneous resolution of the mass, torsion or cyst rupture, or borderline or invasive malignancy confirmed surgically in patients with a newly diagnosed adnexal mass. IOTA5 is registered with ClinicalTrials.gov, number NCT01698632, and the central Ethics Committee and the Belgian Federal Agency for Medicines and Health Products, number S51375/B32220095331, and is ongoing.
Between Jan 1, 2012, and March 1, 2015, 8519 patients were recruited to IOTA5. 3144 (37%) patients selected for conservative management were eligible for inclusion in our analysis, of whom 221 (7%) had no follow-up data and 336 (11%) were operated on before a planned follow-up scan was done. Of 2587 (82%) patients with follow-up data, 668 (26%) had a mass that was already in follow-up at recruitment, and 1919 (74%) presented with a new mass at recruitment (ie, not already in follow-up in the centre before recruitment). Median follow-up of patients with new masses was 27 months (IQR 14–38). The cumulative incidence of spontaneous resolution within 2 years of follow-up among those with a new mass at recruitment (n=1919) was 20·2% (95% CI 18·4–22·1), and of finding invasive malignancy at surgery was 0·4% (95% CI 0·1–0·6), 0·3% (<0·1–0·5) for a borderline tumour, 0·4% (0·1–0·7) for torsion, and 0·2% (<0·1–0·4) for cyst rupture.
Our results suggest that the risk of malignancy and acute complications is low if adnexal masses with benign ultrasound morphology are managed conservatively, which could be of value when counselling patients, and supports conservative management of adnexal masses classified as benign by use of ultrasound.
Research Foundation Flanders, KU Leuven, Swedish Research Council.
Background Accurate methods to preoperatively characterize adnexal tumors are pivotal for optimal patient management. A recent metaanalysis concluded that the International Ovarian Tumor Analysis ...algorithms such as the Simple Rules are the best approaches to preoperatively classify adnexal masses as benign or malignant. Objective We sought to develop and validate a model to predict the risk of malignancy in adnexal masses using the ultrasound features in the Simple Rules. Study Design This was an international cross-sectional cohort study involving 22 oncology centers, referral centers for ultrasonography, and general hospitals. We included consecutive patients with an adnexal tumor who underwent a standardized transvaginal ultrasound examination and were selected for surgery. Data on 5020 patients were recorded in 3 phases from 2002 through 2012. The 5 Simple Rules features indicative of a benign tumor (B-features) and the 5 features indicative of malignancy (M-features) are based on the presence of ascites, tumor morphology, and degree of vascularity at ultrasonography. Gold standard was the histopathologic diagnosis of the adnexal mass (pathologist blinded to ultrasound findings). Logistic regression analysis was used to estimate the risk of malignancy based on the 10 ultrasound features and type of center. The diagnostic performance was evaluated by area under the receiver operating characteristic curve, sensitivity, specificity, positive likelihood ratio (LR+), negative likelihood ratio (LR–), positive predictive value (PPV), negative predictive value (NPV), and calibration curves. Results Data on 4848 patients were analyzed. The malignancy rate was 43% (1402/3263) in oncology centers and 17% (263/1585) in other centers. The area under the receiver operating characteristic curve on validation data was very similar in oncology centers (0.917; 95% confidence interval, 0.901–0.931) and other centers (0.916; 95% confidence interval, 0.873–0.945). Risk estimates showed good calibration. In all, 23% of patients in the validation data set had a very low estimated risk (<1%) and 48% had a high estimated risk (≥30%). For the 1% risk cutoff, sensitivity was 99.7%, specificity 33.7%, LR+ 1.5, LR– 0.010, PPV 44.8%, and NPV 98.9%. For the 30% risk cutoff, sensitivity was 89.0%, specificity 84.7%, LR+ 5.8, LR– 0.13, PPV 75.4%, and NPV 93.9%. Conclusion Quantification of the risk of malignancy based on the Simple Rules has good diagnostic performance both in oncology centers and other centers. A simple classification based on these risk estimates may form the basis of a clinical management system. Patients with a high risk may benefit from surgery by a gynecological oncologist, while patients with a lower risk may be managed locally.
Background Subjective evaluation of gray-scale and Doppler ultrasound findings (i.e., pattern recognition) by an experienced examiner and preoperative serum levels of CA-125 can both discriminate ...benign from malignant adnexal (i.e., ovarian, paraovarian, or tubal) masses. We compared the diagnostic performance of these methods in a large multicenter study. Methods In a prospective multicenter study—the International Ovarian Tumor Analysis—1066 women with a persistent adnexal mass underwent transvaginal gray-scale and color Doppler ultrasound examinations by an experienced examiner within 120 days of surgery. Pattern recognition was used to classify a mass as benign or malignant. Of these women, 809 also had blood collected preoperatively for measurement of serum CA-125. Various levels of CA-125 were used as cutoffs to classify masses. Results from both assays were then compared with histologic findings after surgery. Results Pattern recognition correctly classified 93% (95% confidence interval CI = 90.9% to 94.6%) of the tumors as benign or malignant. Serum CA-125 correctly classified at best 83% (95% CI = 80.3% to 85.6%) of the masses. Histologic diagnoses that were most often misclassified by CA-125 were fibroma, endometrioma, and abscess (false-positive results) and borderline tumor (false-negative results). Pattern recognition correctly classified 86% (95% CI = 81.1% to 90.4%) of masses of these four histologic types as being benign or malignant, whereas a serum CA-125 at a cutoff of 30 U/mL correctly classified 41% (95% CI = 34.4% to 47.5%) of them. Pattern recognition assigned a correct specific histologic diagnosis to 333 (59%, 95% CI = 54.5% to 62.8%) of the 567 benign lesions. Conclusion Pattern recognition was superior to serum CA-125 for discrimination between benign and malignant adnexal masses.
Assessing malignancy risk is important to choose appropriate management of ovarian tumors. We compared six algorithms to estimate the probabilities that an ovarian tumor is benign, borderline ...malignant, stage I primary invasive, stage II-IV primary invasive, or secondary metastatic.
This retrospective cohort study used 5909 patients recruited from 1999 to 2012 for model development, and 3199 patients recruited from 2012 to 2015 for model validation. Patients were recruited at oncology referral or general centers and underwent an ultrasound examination and surgery ≤ 120 days later. We developed models using standard multinomial logistic regression (MLR), Ridge MLR, random forest (RF), XGBoost, neural networks (NN), and support vector machines (SVM). We used nine clinical and ultrasound predictors but developed models with or without CA125.
Most tumors were benign (3980 in development and 1688 in validation data), secondary metastatic tumors were least common (246 and 172). The c-statistic (AUROC) to discriminate benign from any type of malignant tumor ranged from 0.89 to 0.92 for models with CA125, from 0.89 to 0.91 for models without. The multiclass c-statistic ranged from 0.41 (SVM) to 0.55 (XGBoost) for models with CA125, and from 0.42 (SVM) to 0.51 (standard MLR) for models without. Multiclass calibration was best for RF and XGBoost. Estimated probabilities for a benign tumor in the same patient often differed by more than 0.2 (20% points) depending on the model. Net Benefit for diagnosing malignancy was similar for algorithms at the commonly used 10% risk threshold, but was slightly higher for RF at higher thresholds. Comparing models, between 3% (XGBoost vs. NN, with CA125) and 30% (NN vs. SVM, without CA125) of patients fell on opposite sides of the 10% threshold.
Although several models had similarly good performance, individual probability estimates varied substantially.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Mental health problems and obesity are two common complications during pregnancy and postpartum. The preconception period is considered an appropriate period for prevention. Therefore, insights into ...interpregnancy mental health and the impact on weight and body composition are of interest to developing effective weight management strategies. The primary aim of this study is to assess the difference in women's mental health during the interpregnancy period and the association with pre-pregnancy body mass index (BMI) and body composition. The secondary aim is to study whether this association is affected by socio-demographic factors, interpregnancy interval and sleep. The study is a secondary analysis of the INTER-ACT e-health-supported lifestyle trial. Women were eligible if they had a subsequent pregnancy and mental health measurements at 6 weeks after childbirth and at the start of the next pregnancy (
= 276). We used univariate analyses to assess differences in mental health and performed regression analysis to assess their association with pre-pregnancy BMI and body composition at the start of the next pregnancy. Our results show a statistically significant increase in anxiety and depressive symptoms between 6 weeks after childbirth and the start of the next pregnancy (sSTAI-6 ≥ 40: +13%,
=≤ 0.001; GMDS ≥ 13: +9%,
= 0.01). Of the women who were not anxious at 6 weeks after childbirth (sSTAI < 40), more than one-third (39%) developed anxiety at the start of the next pregnancy (
=≤ 0.001). Regression analysis showed that sense of coherence (SOC-13) at the start of the next pregnancy was independently associated with women's pre-pregnancy BMI and fat percentage. We believe that the development of preconception lifestyle interventions that focus on both weight reduction and support in understanding, managing and giving meaning to stressful events (sense of coherence) may be of added value in optimizing women's preconception health.
Objectives To validate recent guidance changes by establishing the performance of cut-off values for embryo crown-rump length and mean gestational sac diameter to diagnose miscarriage with high ...levels of certainty. Secondary aims were to examine the influence of gestational age on interpretation of mean gestational sac diameter and crown-rump length values, determine the optimal intervals between scans and findings on repeat scans that definitively diagnose pregnancy failure.) Design Prospective multicentre observational trial. Setting Seven hospital based early pregnancy assessment units in the United Kingdom. Participants 2845 women with intrauterine pregnancies of unknown viability included if transvaginal ultrasonography showed an intrauterine pregnancy of uncertain viability. In three hospitals this was initially defined as an empty gestational sac <20 mm mean diameter with or without a visible yolk sac but no embryo, or an embryo with crown-rump length <6 mm with no heartbeat. Following amended guidance in December 2011 this definition changed to a gestational sac size <25 mm or embryo crown-rump length <7 mm. At one unit the definition was extended throughout to include a mean gestational sac diameter <30 mm or embryo crown-rump length <8 mm. Main outcome measures Mean gestational sac diameter, crown-rump length, and presence or absence of embryo heart activity at initial and repeat transvaginal ultrasonography around 7-14 days later. The final outcome was pregnancy viability at 11-14 weeks’ gestation. Results The following indicated a miscarriage at initial scan: mean gestational sac diameter ≥25 mm with an empty sac (364/364 specificity: 100%, 95% confidence interval 99.0% to 100%), embryo with crown-rump length ≥7 mm without visible embryo heart activity (110/110 specificity: 100%, 96.7% to 100%), mean gestational sac diameter ≥18 mm for gestational sacs without an embryo presenting after 70 days’ gestation (907/907 specificity: 100%, 99.6% to 100%), embryo with crown-rump length ≥3 mm without visible heart activity presenting after 70 days’ gestation (87/87 specificity: 100%, 95.8% to 100%). The following were indicative of miscarriage at a repeat scan: initial scan and repeat scan after seven days or more showing an embryo without visible heart activity (103/103 specificity: 100%, 96.5% to 100%), pregnancies without an embryo and mean gestational sac diameter <12 mm where the mean diameter has not doubled after 14 days or more (478/478 specificity: 100%, 99.2% to 100%), pregnancies without an embryo and mean gestational sac diameter ≥12 mm showing no embryo heartbeat after seven days or more (150/150 specificity: 100%, 97.6% to 100%). Conclusions Recently changed cut-off values of gestational sac and embryo size defining miscarriage are appropriate and not too conservative but do not take into account gestational age. Guidance on timing between scans and expected findings on repeat scans are still too liberal. Protocols for miscarriage diagnosis should be reviewed to account for this evidence to avoid misdiagnosis and the risk of terminating viable pregnancies.
Abstract Incarceration of the gravid uterus is a rare obstetric disorder that is often not recognized despite the ready availability of ultrasound. However, detailed imaging of the disturbed uterine ...and pelvic anatomy – from an obstetric point of view- is the key in reducing the potentially severe complications of this condition and planning its treatment. In this paper, we will describe the specific magnetic resonance imaging (MRI) features of an incarceration of the gravid uterus and we will discuss the role of magnetic resonance imaging in defining anatomy and in the medical decision whether to operate or not.
Coronavirus disease (COVID-19) and its mitigation measures have been associated with changes in preterm birth (PTB) incidences. The objective of this paper is to summarize and comment on the ...literature on COVID-19 and PTB and to compare PTB incidence between 2019 (pre-COVID-19) and 2020 (COVID-19) in three Belgian tertiary care hospitals.
A non-systematic review on COVID-19 and PTB was performed, and literature was summarized in a table. Preterm birth rates at Ghent University Hospital, Ziekenhuis Oost-Limburg, and University Hospital Leuven in 2019 and 2020 were compared. Chi-square and Fisher's exact tests were used to compare PTB rates between 2019 and 2020, and Kaplan Meier survival analysis was used to compare pregnancy duration. The mean outcome measure was PTB incidence in 2020 (COVID-19) compared with PTB incidence in 2019 (pre-COVID-19).
Some (parts of) countries report decreases in PTB rates, others report no differences in incidence, and a minority of countries report an increased incidence of PTB. Almost all studies only consider live-births. In three tertiary care hospitals in Flanders, there were no differences in PTB rates before and during the COVID-19 pandemic.
The impact of the (mitigation measures during the) COVID-19 pandemic on PTB incidence is unclear and difficult to explore. To enable a correct interpretation, all conceptions before and during the pandemic should be taken into consideration, as well as all births, still or alive.
The transition to parenthood is a cornerstone event for both parents, potentially leading to relevant changes in lifestyle and behaviour. In women, the metabolic changes during and after pregnancy ...and the deleterious effects of excessive gestational weight gain and postpartum weight retention have been extensively described. However, there is no full understanding about which specific energy balance related behaviours (EBRB) contribute to unfavourable weight gain and weight retention. Furthermore, information on how transition to parenthood affects men is lacking. Therefore, this study aims to investigate changes in body weight, body composition and EBRB in couples transitioning to parenthood.
TRANSPARENTS is a multi-centre observational follow-up study that focuses on body weight, body composition and EBRB during the transition to parenthood. Couples (women and men) will be recruited during the first trimester of their first pregnancy. Study visits will occur at four occasions (12 weeks of pregnancy, 6 weeks postpartum, 6 months postpartum and 12 months postpartum). Anthropometrics of the parents and new-borns will be assessed including body weight, height/length, body composition (using bio-electrical impedance analysis and measurement of four skinfold thicknesses (biceps, triceps, subscapular and supraspinal/suprailiac)) and waist and hip circumference. Dietary intake, physical activity, sedentary behaviour, smoking habits, sleeping pattern, fatigue, diet and exercise related partner support, mental health, breastfeeding, contraception use, and socio-demographics will be assessed using a questionnaire. In addition, accelerometry will be used to assess physical activity and sedentary behaviour objectively. Also data from women's medical record, such as pre-pregnancy weight and pregnancy outcomes, will be included. Multilevel modelling will be used to evaluate maternal and paternal changes in body weight, body composition and EBRB during and after pregnancy (primary outcomes). Multiple linear regression analyses will be performed to identify predictors of changes in body weight, body composition and EBRB. All analyses will be adjusted for possible confounders.
TRANSPARENTS is a unique project identifying vulnerable parents and (un)favourable changes in EBRB throughout this potentially critical life period. Provided insights will facilitate the development of effective intervention strategies to help couples towards a healthy transition to parenthood.
Clinicaltrials.gov Identifier: NCT03454958. Registered March 2018.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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