Effect of the COVID-19 pandemic on surgery for indeterminate thyroid nodules (THYCOVID): a retrospective, international, multicentre, cross-sectional study

Background Since its outbreak in early 2020, the COVID-19 pandemic has diverted resources from non-urgent and elective procedures, leading to diagnosis and treatment delays, with an increased number of neoplasms at advanced stages worldwide. The aims of this study were to quantify the reduction in surgical activity for indeterminate thyroid nodules during the COVID-19 pandemic; and to evaluate whether delays in surgery led to an increased occurrence of aggressive tumours.Methods In this retrospective, international, cross-sectional study, centres were invited to participate in June 22, 2022; each centre joining the study was asked to provide data from medical records on all surgical thyroidectomies consecutively performed from Jan 1, 2019, to Dec 31, 2021. Patients with indeterminate thyroid nodules were divided into three groups according to when they underwent surgery: from Jan 1, 2019, to Feb 29, 2020 (global prepandemic phase), from March 1, 2020, to May 31, 2021 (pandemic escalation phase), and from June 1 to Dec 31, 2021 (pandemic decrease phase). The main outcomes were, for each phase, the number of surgeries for indeterminate thyroid nodules, and in patients with a postoperative diagnosis of thyroid cancers, the occurrence of tumours larger than 10 mm, extrathyroidal extension, lymph node metastases, vascular invasion, distant metastases, and tumours at high risk of structural disease recurrence. Univariate analysis was used to compare the probability of aggressive thyroid features between the first and third study phases. The study was registered on ClinicalTrials.gov, NCT05178186.Findings Data from 157 centres (n=49 countries) on 87 467 patients who underwent surgery for benign and malignant thyroid disease were collected, of whom 22 974 patients (18 052 [78 center dot 6%] female patients and 4922 [21 center dot 4%] male patients) received surgery for indeterminate thyroid nodules. We observed a significant reduction in surgery for indeterminate thyroid nodules during the pandemic escalation phase (median monthly surgeries per centre, 1 center dot 4 [IQR 0 center dot 6-3 center dot 4]) compared with the prepandemic phase (2 center dot 0 [0 center dot 9-3 center dot 7]; p<0 center dot 0001) and pandemic decrease phase (2 center dot 3 [1 center dot 0-5 center dot 0]; p<0 center dot 0001). Compared with the prepandemic phase, in the pandemic decrease phase we observed an increased occurrence of thyroid tumours larger than 10 mm (2554 [69 center dot 0%] of 3704 vs 1515 [71 center dot 5%] of 2119; OR 1 center dot 1 [95% CI 1 center dot 0-1 center dot 3]; p=0 center dot 042), lymph node metastases (343 [9 center dot 3%] vs 264 [12 center dot 5%]; OR 1 center dot 4 [1 center dot 2-1 center dot 7]; p=0 center dot 0001), and tumours at high risk of structural disease recurrence (203 [5 center dot 7%] of 3584 vs 155 [7 center dot 7%] of 2006; OR 1 center dot 4 [1 center dot 1-1 center dot 7]; p=0 center dot 0039).Interpretation Our study suggests that the reduction in surgical activity for indeterminate thyroid nodules during the COVID-19 pandemic period could have led to an increased occurrence of aggressive thyroid tumours. However, other compelling hypotheses, including increased selection of patients with aggressive malignancies during this period, should be considered. We suggest that surgery for indeterminate thyroid nodules should no longer be postponed even in future instances of pandemic escalation.Funding None.Copyright (c) 2023 Published by Elsevier Ltd. All rights reserved

Vulnerable newborn types: analysis of subnational, population-based birth cohorts for 541 285 live births in 23 countries, 2000–2021

Objective: To examine prevalence of novel newborn types among 541 285 live births in 23 countries from 2000 to 2021. Design: Descriptive multi-country secondary data analysis. Setting: Subnational, population-based birth cohort studies (n = 45) in 23 low- and middle-income countries (LMICs) spanning 2000–2021. Population: Liveborn infants. Methods: Subnational, population-based studies with high-quality birth outcome data from LMICs were invited to join the Vulnerable Newborn Measurement Collaboration. We defined distinct newborn types using gestational age (preterm [PT], term [T]), birthweight for gestational age using INTERGROWTH-21st standards (small for gestational age [SGA], appropriate for gestational age [AGA] or large for gestational age [LGA]), and birthweight (low birthweight, LBW [<2500 g], nonLBW) as ten types (using all three outcomes), six types (by excluding the birthweight categorisation), and four types (by collapsing the AGA and LGA categories). We defined small types as those with at least one classification of LBW, PT or SGA. We presented study characteristics, participant characteristics, data missingness, and prevalence of newborn types by region and study. Results: Among 541 285 live births, 476 939 (88.1%) had non-missing and plausible values for gestational age, birthweight and sex required to construct the newborn types. The median prevalences of ten types across studies were T+AGA+nonLBW (58.0%), T+LGA+nonLBW (3.3%), T+AGA+LBW (0.5%), T+SGA+nonLBW (14.2%), T+SGA+LBW (7.1%), PT+LGA+nonLBW (1.6%), PT+LGA+LBW (0.2%), PT+AGA+nonLBW (3.7%), PT+AGA+LBW (3.6%) and PT+SGA+LBW (1.0%). The median prevalence of small types (six types, 37.6%) varied across studies and within regions and was higher in Southern Asia (52.4%) than in Sub-Saharan Africa (34.9%). Conclusions: Further investigation is needed to describe the mortality risks associated with newborn types and understand the implications of this framework for local targeting of interventions to prevent adverse pregnancy outcomes in LMICs.The Children's Investment Fund Foundation, grant 2004-04670. The funders had no role in the study design, data collection, analysis or interpretation of the paper

Vulnerable newborn types: analysis of subnational, population-based birth cohorts for 541 285 live births in 23 countries, 2000-2021.

OBJECTIVE: To examine prevalence of novel newborn types among 541 285 live births in 23 countries from 2000 to 2021. DESIGN: Descriptive multi-country secondary data analysis. SETTING: Subnational, population-based birth cohort studies (n = 45) in 23 low- and middle-income countries (LMICs) spanning 2000-2021. POPULATION: Liveborn infants. METHODS: Subnational, population-based studies with high-quality birth outcome data from LMICs were invited to join the Vulnerable Newborn Measurement Collaboration. We defined distinct newborn types using gestational age (preterm [PT], term [T]), birthweight for gestational age using INTERGROWTH-21st standards (small for gestational age [SGA], appropriate for gestational age [AGA] or large for gestational age [LGA]), and birthweight (low birthweight, LBW [<2500 g], nonLBW) as ten types (using all three outcomes), six types (by excluding the birthweight categorisation), and four types (by collapsing the AGA and LGA categories). We defined small types as those with at least one classification of LBW, PT or SGA. We presented study characteristics, participant characteristics, data missingness, and prevalence of newborn types by region and study. RESULTS: Among 541 285 live births, 476 939 (88.1%) had non-missing and plausible values for gestational age, birthweight and sex required to construct the newborn types. The median prevalences of ten types across studies were T+AGA+nonLBW (58.0%), T+LGA+nonLBW (3.3%), T+AGA+LBW (0.5%), T+SGA+nonLBW (14.2%), T+SGA+LBW (7.1%), PT+LGA+nonLBW (1.6%), PT+LGA+LBW (0.2%), PT+AGA+nonLBW (3.7%), PT+AGA+LBW (3.6%) and PT+SGA+LBW (1.0%). The median prevalence of small types (six types, 37.6%) varied across studies and within regions and was higher in Southern Asia (52.4%) than in Sub-Saharan Africa (34.9%). CONCLUSIONS: Further investigation is needed to describe the mortality risks associated with newborn types and understand the implications of this framework for local targeting of interventions to prevent adverse pregnancy outcomes in LMICs

Importancia del diagnóstico prenatal de las cardiopatías congénitas

Resumen: En México, la última estadística del INEGI del año 2015 muestra que la segunda causa de mortalidad infantil se debe a malformaciones congénitas las cuales en su mayoría son cardiopatías congénitas. El periodo neonatal es la etapa en la cual ocurren la mayoría de las muertes por esta condición. Tan solo durante el año de 2013, se reportaron en México 3,593 fallecimientos secundarios a cardiopatías congénitas en niños menores de un año, dentro de las cuales más del 50% ocurrieron en el periodo del recién nacido. En países con un programa de tamizaje prenatal estructurado, el diagnóstico de las cardiopatías congénitas críticas en la vida fetal ha mostrado una reducción en la mortalidad en el periodo neonatal. El diagnóstico prenatal de este grupo de patologías es crucial para poder brindar un tratamiento de forma oportuna y mejorar el pronóstico de las personas que las padecen en nuestro país. El Instituto Nacional de Perinatología ha desarrollado una metodología para la detección oportuna en la vida fetal y manejo perinatal de las cardiopatías congénitas y pretende impulsar un Programa Nacional para el tamizaje de este grupo de enfermedades. En colaboración con los Institutos Nacionales de Salud donde se llevan a cabo las cirugías cardiovasculares en la edad pediátrica, el programa pretende mejorar la atención y el pronóstico de los pacientes con cardiopatías congénitas. Abstract: According to latest official statistical results for 2015, the second cause of child death in Mexico is congenital malformation, most of which are congenital heart diseases. The neonatal period is the phase in which most deaths associated with this condition occurs. During 2013 alone, a total of 3,593 children under 1 year of age had a reported death in Mexico due to congenital heart diseases, and more than 50% of them occurred while they were newborns. Diagnosing critical heart diseases during the foetal period in countries with a structured prenatal screening process have shown a decrease in deaths during newborn stages. Foetal diagnosis of this group of diseases is crucial in order to provide proper treatment and improve prognosis for people suffering from them in our country. The National Perinatology Institute has developed a methodology for the timely diagnosis during foetal stages and the perinatal management of heart diseases, and aims to launch a national screening program for this group of diseases. Collaborating with the Nacional Health Institute, where cardiovascular surgeries are performed on paediatric patients, this program aspires to improve both the care and prognosis for patients with heart diseases. Palabras clave: Defectos fetales, Defectos cardiacos, Diagnóstico prenatal, Keywords: Foetal defects, Cardiac defects, Prenatal diagnosi

Efectos biológicos adversos y seguridad del ultrasonido en el embarazo. Revisión sistemática

Resumen: Introducción: Actualmente el ultrasonido representa una herramienta indispensable en el control prenatal. Debido a que no se han reportado efectos adversos en humanos, la mayoría de los profesionales de la salud y pacientes lo consideran un procedimiento seguro, haciéndose incluso un uso indiscriminado de este. Objetivo: Conocer la mejor evidencia científica disponible acerca de la seguridad y los potenciales efectos biológicos adversos del ultrasonido prenatal. Material y métodos: Se realizó una búsqueda en las bases de datos PubMed y Medline considerando para el análisis los estudios que evaluaron algún tipo de efecto a corto o a largo plazo de la exposición prenatal al ultrasonido en sus diferentes modalidades. Resultados: Se identificaron un total de 9,115 citas. Se incluyeron 18 estudios, de los cuales 8 fueron realizados en animales y 10 en humanos; de estos últimos, 8 correspondieron al diseño de cohorte y 2 al de casos y controles. Debido a la heterogeneidad de las poblaciones, exposiciones y resultados, no fue posible realizar un análisis estadístico. Además de una asociación débil con el uso preferente de la mano izquierda en niños, no existe evidencia de que la exposición prenatal al ultrasonido se asocie a efectos adversos importantes. Conclusiones: La ausencia de evidencia de daño no es equivalente a evidencia de ausencia de este, por lo que es todavía prudente exponer a nuestras pacientes a la menor cantidad de energía ultrasónica necesaria. El conocimiento de los operadores acerca del uso seguro del ultrasonido es la mejor estrategia para disminuir los potenciales efectos adversos. Abstract: Introduction: Nowadays ultrasound is a necessary tool in prenatal care. As no adverse effects have been reported in humans, health care professionals and patients consider an ultrasound scan in pregnancy to be a safe procedure, even making indiscriminate use of this tool. Objective: To evaluate the best available scientific evidence regarding the safety and potential biological adverse effects of ultrasound in pregnancy. Material and methods: A systematic search was conducted in the electronic databases PubMed and Medline. Studies that assessed the short and long term effects of ultrasound exposure during pregnancy in its different modalities were included. Results: A total of 9,115 references were identified. Of the 18 studies included in the analysis, eight were conducted on animals and 10 in humans. From the latter, eight were cohort studies and two were case control studies. Due to the heterogeneity of the populations, exposures and outcomes measured, a statistical analysis was not feasible. Apart from a weak association between exposure to ultrasound and left-handedness in boys, there was no evidence that prenatal exposure to ultrasound is associated with major adverse effects. Conclusions: Absence of evidence of harm is not equivalent to absence of harm; therefore it is still prudent to expose our patients to the least amount of ultrasound energy necessary. Knowledge by ultrasound operators about the safe use of ultrasound during pregnancy is the best strategy to prevent its potential adverse effects. Palabras clave: Ultrasonido, Embarazo, Efectos adversos, Seguridad, Feto, Keywords: Ultrasound, Pregnancy, Adverse effects, Safety, Foetu

Resultados perinatales adversos en colestasis intrahepática del embarazo

Resumen: Objetivo: Describir los resultados perinatales en pacientes con colestasis intrahepática del embarazo (CIE) en el Instituto Nacional de Perinatología. Material y métodos: Se realizó un estudio de serie de casos, retrolectivo y observacional durante el periodo 2012-2015, en el Instituto Nacional de Perinatología. Se incluyeron expedientes de pacientes con embarazo único o gemelar con diagnóstico de CIE. Resultados: Se estudiaron 25 expedientes de pacientes; el 32% de las pacientes eran primigestas. El diagnóstico se realizó de manera clínica en el 100% de las pacientes. Se corroboró mediante elevación de enzimas hepáticas en 21 pacientes. Se solicitaron ácidos biliares en el 48% de las pacientes, de los cuales 67% se reportaron > 10 mmol/l. Una paciente se clasificó como CIE severa (ácidos biliares > 100 mmol/l). El 68% de las pacientes recibieron tratamiento con ácido ursodesoxicólico. El parto pretérmino se presentó en el 40% de los casos, el 24% de ellos espontáneos y el 16% iatrogénicos. Dos pacientes (8%) desarrollaron preeclampsia leve. Se obtuvo un total de 26 recién nacidos, ya que uno de los embarazo fue un embarazo gemelar. Un recién nacido presentó peso bajo para edad gestacional. El 12% de los recién nacidos requirieron de cuidados intensivos. Se reportó meconio en 3 ocasiones. El Apgar promedio fue de 8/9. Conclusión: Existen varias diferencias en el manejo de las pacientes con CIE en el Instituto Nacional de Perinatología. Es indispensable que existan lineamientos internos para homogeneizar su diagnóstico, seguimiento y tratamiento. Abstract: Objective: To describe the perinatal and maternal outcomes of patients with intrahepatic cholestasis of pregnancy (ICP) in the National Institute of Perinatology. Material and method: A retrospective, observational study was conducted that included clinical files of women with single or multiple pregnancy with ICP between January 2012 and December 2015. Results: A total of 25 patient files were included, 32% of whom were primiparous. On the multiparous, 2 stillbirths were recorded in their previous pregnancy (these patients had a history of ICP). The diagnosis was carried out clinically in 100% of the cases. It was then confirmed by hepatic enzyme elevation in 21 patients. Bile acids were requested for 48% of the patients, of which 67% were reported as > 10 mmol/L. One patient was classified as severe ICP (bile acids > 100 mmol/L. Around two-thirds (68%) of patients received ursodeoxycholic acid. The birth was preterm in 40% of the patients 24% were spontaneous and 16% iatrogenic, and 2 patients (8%) developed mild pre-eclampsia. There were a total of 26 newborns, as one of the patients was carrying twins. One newborn was small for gestational age. Admission to neonatal intensive care unit was required for 12% of the newborns, and 3 cases of meconium were reported. The mean Apgar score was 8/9. Conclusion: The treatment for patients with ICP in the present hospital varies significantly. Therefore, it is essential to develop internal guidelines to homogenise the diagnosis, follow-up, and treatment of the patients. Palabras clave: Óbito, Colestasis intrahepática, Embarazo, Ácido ursodesoxicólico, Keywords: Stillbirth, Intrahepatic cholestasis, Pregnancy, Ursodeoxycholic aci

Construcción, fiabilidad y exactitud de un cuestionario para evaluar el conocimiento de médicos ginecoobstetras y residentes de ginecología y obstetricia sobre vacunas en el embarazo y lactancia

Resumen: Introducción: Las vacunas durante el embarazo son una práctica con nivel de evidencia 1 A para prevenir el desarrollo de enfermedades transmisibles en la madre y en el feto. Sin embargo existe evidencia de un desconocimiento y poca aplicación en la práctica habitual. Objetivos: Construir y validar un instrumento para medir el grado de conocimiento de los ginecoobstetras y médicos residentes de ginecoobstetricia sobre vacunación en mujeres embarazadas y lactancia. Tipo de estudio: Descriptivo, transversal tipo encuesta. Métodos: Se construyó y validó el cuestionario en 30 médicos ginecoobstetras y residentes de ginecoobstetricia en el INPer durante un turno elegido al azar. Análisis estadístico: Se empleo estadística descriptiva en frecuencias y porcentajes. Se realizará pruebas de fiabilidad (tes-retest, alfa de Cronbach) y validez (apariencia, contenido y constructo) y reproducibilidad (índice de Kappa). Resultados: Se logró la construcción, estandarización y validación del cuestionario, con un alfa de Cronbach de 0.85 y un índice de Kappa de 0.95. Se deberá realizar en una segunda fase la aplicación del cuestionario ya validado a la población diana para determinar el conocimiento en cuanto a vacunación en el embarazo y lactancia. Conclusiones: El instrumento final (Anexo 1), contiene los ítems adecuados en función de la exactitud y la fiabilidad requeridos para representar de manera general el conocimiento de personal médico (ginecoobstetras y médicos residentes en ginecoobstetricia) sobre el tema de vacunación en el embarazo y lactancia. Abstract: Introduction: The vaccines during pregnancy are a practice with an evidence level of 1A, and are used to prevent the development of communicable diseases in the mother and the foetus. However, there is evidence of ignorance and lack of application in routine practice. Objectives: To develop and validate a tool to measure the level of knowledge of gynaecologists and obstetricians, as well as medical residents on vaccination in pregnant and breast-feeding women. Type of study: A descriptive, cross-sectional-type questionnaire. Methods: The questionnaire was constructed and validated by 30 gynaecologists and residents in obstetrics and gynaecology during a shift chosen randomly. Statistical analysis: Descriptive statistics were used with frequencies and percentages. Reliability testing (test-retest reliability, Cronbach's alpha) and validity (construct Content and appearance), and reproducibility (Kappa index) will be performed. Results: Construction, standardisation and validation of the questionnaire was achieved with a Cronbach's alpha of 0.85 and 0.95 Kappa index. A second phase evaluation should be performed after the implementation of the questionnaire, and validated with the target population to determine the knowledge regarding vaccination in pregnancy and lactation. Conclusions: The final instrument (Appendix 1) contains the appropriate items depending on the accuracy and reliability required to present the knowledge of medical staff (obstetricians-gynaecologists and gynaecology-obstetrics residents) on the subject of vaccination in pregnancy and lactation. Palabras clave: Embarazo, Vacunación, Cuestionario, Keywords: Pregnancy, Vaccination, Questionnair

Efectos de los esteroides como inductores de maduración pulmonar en restricción del crecimiento intrauterino. Revisión sistemática

Resumen: Introducción: La restricción del crecimiento intrauterino (RCIU) está asociada con morbimortalidad perinatal, causante del aumento de la morbimortalidad fetal y neonatal, incluyendo prematurez. Los glucocorticoides se administran de forma rutinaria a las mujeres con embarazos entre 24 y 34 semanas de gestación en riesgo de parto prematuro para promover la producción de surfactante; sin embargo, se ha postulado que su administración exógena en fetos con RCIU podría no brindar ningún beneficio extra: no existe suficiente evidencia para apoyar su uso en este subgrupo de pacientes. Métodos: Para la creación de esta revisión sistemática, se realizaron búsquedas en las bases de datos Medline, PubMed y Cochrane para citas relevantes. Se han utilizado estudios con mayor nivel de evidencia que en los que se administraron glucocorticoides (dexametasona o betametasona) como inductores de maduración pulmonar y se ha comparado su uso con no aplicar ningún tratamiento, durante las semanas 24-34 semanas de gestación, en embarazos con diagnóstico de RCIU. Resultados: Tras la evaluación metodológica, se utilizaron 6 artículos para la creación de esta revisión. Conclusiones: El uso de glucocorticoides en la población de fetos pretérmino con restricción del crecimiento aún es controvertido, sin estudios clínicos aleatorizados en humanos que nos permitan emitir recomendaciones adecuadas para su uso. Abstract: Introduction: Intrauterine growth restriction (IUGR) is associated with perinatal morbidity and mortality. This includes increased foetal and neonatal morbidity and mortality, as well as prematurity. Glucocorticoids are given routinely to women between 24-34 weeks gestation at risk of preterm delivery. These are given to promote the production of surfactant. Although it has been postulated that the exogenous administration in IUGR may not provide any extra benefit, there is insufficient evidence to support its use in this sub-group of patients. Methods: In order to perform this systematic review, a search was made of the Medline, PubMed and Cochrane databases for relevant literature references. Those studies with a higher level of evidence that administered glucocorticoids (dexamethasone or betamethasone) to induce pulmonary maturation were selected and were compared with those using no treatment, during weeks 24-34 weeks gestation in pregnancies diagnosed with IUGR. Results: After assessment of the methodology, 6 items were used to create this review. Conclusions: Assessing the use of glucocorticoids in the pre-term foetus population with growth restriction remains controversial, with no randomised clinical studies in humans that allow us to make recommendations suitable for use. Palabras clave: Restricción del crecimiento intrauterino, Glucocorticoides, Maduración pulmonar, Keywords: Intrauterine growth restriction, Glucocorticoids, Lung maturatio