Prospective external validation of IOTA three-step strategy for characterizing and classifying adnexal masses and retrospective assessment of alternative two-step strategy using simple-rules risk.

OBJECTIVES: To perform an external validation of the diagnostic performance of the three-step strategy proposed by the International Ovarian Tumor Analysis (IOTA) group for classifying adnexal masses as benign or malignant, when ultrasound is performed by non-expert sonographers in the first two steps. The second objective was to assess the diagnostic performance of an alternative strategy using simple-rules risk (SRR), instead of simple rules (SR), in the second step. METHODS: This was a prospective observational study conducted at two university hospitals, from September 2015 to August 2017, of consecutive patients diagnosed with an adnexal mass. All women were evaluated by ultrasound using the IOTA three-step strategy. Non-expert sonographers performed the first step (use of simple descriptors to classify the masses) and the second step (use of SR if the mass could not be classified in the first step); masses that could not be classified in the first two steps were categorized by an expert sonographer based on their subjective assessment (third step). The reference standard was histological diagnosis in patients who underwent surgery or at least 12 months of follow-up in cases managed expectantly. The sensitivity, specificity, positive (LR+) and negative (LR-) likelihood ratios and overall accuracy of the IOTA three-step strategy were estimated. Furthermore, we evaluated retrospectively an alternative two-step strategy using SRR in the second step to categorize the masses not classifiable with simple descriptors, classifying the lesions as being of low, intermediate or high risk for malignancy. The diagnostic performance of this strategy was estimated by calculating its sensitivity and specificity, assuming surgical intervention for intermediate- or high-risk lesions. RESULTS: The study included 283 patients (median age, 48 (range, 18-90) years), of whom 165 (58.3%) were premenopausal and 118 (41.7%) postmenopausal. Two hundred and sixteen (76.3%) women underwent surgery (154 benign and 62 malignant masses) and 67 (23.7%) were managed expectantly with serial ultrasound follow-up for at least 12 months. All expectantly managed masses were considered benign because no sonographic changes suggestive of malignancy were observed during follow-up. Simple descriptors could be applied in 126 (44.5%) masses. Of the remaining 157 lesions, 112 (39.6%) could be characterized using SR. Therefore, 238 (84.1%) masses could be classified by non-expert sonographers in the first two steps. Of the remaining 45 (15.9%) masses, all could be classified by an expert sonographer. Overall sensitivity, specificity, LR+ and LR- of the IOTA three-step strategy were 95.2%, 97.7%, 42.1 and 0.05, respectively. The diagnostic accuracy was 97.2%. Following the two-step strategy using SRR in the second step, of the 157 lesions not classified with simple descriptors, 42, 38 and 77 presented low, intermediate or high risk for malignancy, respectively. Based on this method, 210 women would have undergone surgical treatment. The sensitivity and specificity of this two-step strategy were 98.4% and 63.8%, respectively. CONCLUSIONS: The IOTA three-step strategy shows high accuracy for discriminating between benign and malignant adnexal lesions when used by non-expert sonographers. An alternative strategy using the SRR calculator in the second step might improve on this diagnostic performance by decreasing the number of surgical interventions and increasing sensitivity. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

External validation of IOTA simple descriptors and simple rules for classifying adnexal masses.

OBJECTIVE: To assess the diagnostic performance of a three-step strategy proposed by the International Ovarian Tumor Analysis (IOTA) Group for discriminating between benign and malignant adnexal masses. METHODS: This was a prospective observational study, performed at two tertiary-care university hospitals, of women diagnosed with an adnexal mass on transvaginal or transabdominal ultrasound between December 2012 and December 2014. Women were scheduled for an ultrasound evaluation, which was initially performed by non-expert examiners. The examiner had to classify the mass using 'simple descriptors' (first step) and, if not possible, using 'simple rules' (second step). For inconclusive masses, an expert examiner classified the mass according to their subjective impression (third step). Masses were managed expectantly, with serial follow-up examinations, or surgically, according to ultrasound findings and clinical symptoms. Histology was used as the reference standard. Masses that were managed expectantly with at least 1 year of follow-up were considered as benign for analytical purposes. Women with less than 1 year of follow-up were not included in the study. RESULTS: Six hundred and sixty-six women were included (median age, 41 (range, 18-81) years) of whom 514 were premenopausal and 152 were postmenopausal. Based on the three-step strategy, 362 women had surgical removal of the mass (53 malignant and 309 benign), 71 masses resolved spontaneously and 233 persisted. Four hundred and forty-eight (67.3%) of 666 masses could be classified using simple descriptors and, of the 218 that could not, 147 (67.4%) were classified using simple rules. Of the remaining 71 masses, the expert examiner classified 45 as benign, 12 as malignant and 14 as uncertain. Overall sensitivity, specificity, positive likelihood ratio and negative likelihood ratio of the three-step strategy were 94.3%, 94.9%, 18.6 and 0.06, respectively. CONCLUSION: The IOTA three-step strategy, based on the sequential use of simple descriptors, simple rules and expert evaluation, performs well for classifying adnexal masses as benign or malignant. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Screening de primer trimestre de preeclampsia tardía en gestantes de bajo riesgo en un centro de bajo volumen obstétrico: validación externa de un modelo predictivo / First trimester screening of late-onset preeclampsia in a low risk and low volume obstetrical setting: external validation of a predictive model

Fundamento: La validación externa de un modelo predictivo de predicción de preeclampsia tardía en un centro de bajo volumen obstétrico en gestantes de bajo riesgo obstétrico. Métodos: Estudio prospectivo de 174 gestaciones únicas de 11+0 a 13+6 semanas de gestación en la Clínica Universidad de Navarra desde septiembre 2011 a marzo de 2013, que fue considerado como una cohorte de validación de un modelo descrito anteriormente para preeclampsia tardía en el hospital Clínic de Barcelona). Resultados: Un total de 7 (4%) mujeres desarrollaron PE tardía. En la cohorte de validación el área bajo la curva del modelo fue de 0,69 (IC del 95% 0,45 a 0,93). Las tasas de detección para un 5, 10 y 15% de tasas de falsos positivos fueron 21,9, 31,4 y 38,6%. Al comparar las áreas bajo la curva de la cohorte de validación con la cohorte de la construcción, no se encontraron diferencias estadísticamente significativas (p = 0,68). Conclusión: La combinación de la historia clínica materna, la proteína placentaria A-asociada al embarazo y presión arterial media es moderadamente útil para predecir preeclampsia tardía en gestantes de bajo riesgo y en un centro de bajo volumen obstétrico. El modelo predictivo del hospital Clinic de Barcelona es una herramienta válida para predecir preeclampsia tardía en este entorno (AU)

Background: The external validation of predictive model of late preeclampsia in a low volume and low risk obstetrical setting. Methods: A cohort was created of 174 singleton pregnancies of 11+0-13+6 gestational weeks at Clinica Universidad Navarra from September 2011 to March 2013, which was considered as a validation cohort of a previously described model for late PE (Hospital Clinic, Barcelona). Results: A total of 7 (4%) women developed late PE. In the validation cohort the area under the curve of the model was 0.69 (95% CI 0.45-0.93). Detection rates for a 5, 10 and 15% of false positive rates were 21.9, 31.4% and 38.6% respectively. When comparing the areas under the curve of the validation cohort with the construction cohort, no statistical differences were found (p=0.68). Conclusion: The combination of maternal history, pregnancy associated plasma protein-A and mean arterial pressure is moderately useful to predict preeclampsia in a low risk and low volume obstetrical setting. The predictive model of the Clinic Hospital of Barcelona is a valid tool in predicting late preeclampsia in this setting (AU)

[First trimester screening of late-onset preeclampsia in a low risk and low volume obstetrical setting: external validation of a predictive model]. / Screening de primer trimestre de preeclampsia tardía en gestantes de bajo riesgo en un centro de bajo volumen obstétrico: validación externa de un modelo predictivo

BACKGROUND: The external validation of predictive model of late preeclampsia in a low volume and low risk obstetrical setting. METHODS: A cohort was created of 174 singleton pregnancies of 11+0-13+6 gestational weeks at Clinica Universidad Navarra from September 2011 to March 2013, which was considered as a validation cohort of a previously described model for late PE (Hospital Clinic, Barcelona). RESULTS: A total of 7 (4%) women developed late PE. In the validation cohort the area under the curve of the model was 0.69 (95% CI 0.45-0.93). Detection rates for a 5, 10 and 15% of false positive rates were 21.9, 31.4% and 38.6% respec-tively. When comparing the areas under the curve of the validation cohort with the construction cohort, no statistical differences were found (p=0.68). CONCLUSION: The combination of maternal history, pregnancy associated plasma protein-A and mean arterial pressure is moderately useful to predict preeclampsia in a low risk and low volume obstetrical setting. The predictive model of the Clinic Hospital of Barcelona is a valid tool in predicting late preeclampsia in this setting.

[Confidence assessment among medical students trained with an obstetric simulator]. / Confianza de los estudiantes de medicina en el aprendizaje de la exploración obstétrica con simuladores.

BACKGROUND: To determine the degree of confidence of students regarding obstetric examination before and after training with simulators, and assess their satisfaction with the use of simulation as a tool for acquiring skills. METHODS: Training groups involved 10 students per lecturer. Students learned how to perform Leopold's manoeuvres and measure uterine height with a simulator. The instructor supervised each physical exam. Surveys by those students who had previously done an internship at the Department of Obstetric & Gynecology were not taken into account. RESULTS: Students' confidence in performing the procedures improved significantly (p≤0.001) after the intervention.

Confianza de los estudiantes de medicina en el aprendizaje de la exploración obstétrica con simuladores / Confidence assessment among medical students trained with an obstetric simulator

Fundamento. Conocer el grado de confianza de los alumnos respecto a la exploración obstétrica antes y después del entrenamiento con simuladores, y valorar su satisfacción respecto a la utilización de la simulación como herramienta facilitadora de adquisición de habilidades. Material y métodos. Los grupos de prácticas estaban formados por un profesor y 10 alumnos. Los estudiantes aprendieron sobre un simulador de embarazo a realizarlas maniobras de Leopold y medición de la altura uterina. Cada exploración obstétrica era supervisada por el docente. No se tuvieron en cuenta las encuestas de confianza y satisfacción de los alumnos que habían realizado previamente la pasantía por el Departamento de Obstetricia y Ginecología. Resultados. Se observó una mejora de confianza para ambas habilidades después del taller con el simulador de embarazo (p≤0,001). Conclusiones. El entrenamiento con el simulador mejora la confianza de los alumnos respecto a la adquisición de habilidades en obstetricia (AU)

Background. To determine the degree of confidence of students regarding obstetric examination before and after training with simulators, and assess their satisfaction with the use of simulation as a tool for acquiring skills. Methods. Training groups involved 10 students per lecturer. Students learned how to perform Leopold’s manoeuvres and measure uterine height with a simulator. The instructor supervised each physical exam. Surveys by those students who had previously done an internship at the Department of Obstetric & Gynecology were not taken into account. Results. Students’ confidence in performing the procedures improved significantly (p≤0.001) after the intervention. Conclusions. Simulator training improved the medical students’ confidence in performing obstetric exam (AU)