The techniques of assisted human reproduction and their regulation under spanish legal system.

La prevalencia de esterilidad en la población española, estimada en un 15 % de las parejas en edad fértil, y su incremento progresivo en los últimos años han generado un fuerte aumento de la demanda de técnicas de asistencia a la reproducción que ha duplicado durante quince años el número de centros sanitarios que ofrecen una o varias de estas técnicas de reproducción humana asistida (TRHA). La demanda ya no procede solo de parejas estériles en las que han fracasado las medidas terapéuticas, quirúrgicas y médicas, sino que se han añadido otros colectivos que recurren a las TRHA como primera opción, lo que permite suponer un aumento de la demanda en los próximos años, unido a la mayor eficacia de estas técnicas. Sin embargo, estas técnicas no están exentas de graves controversias debido a los fuertes problemas legales y éticos que generan. Estos dos aspectos son el objeto de este trabajo, analizando las respuestas que da nuestra legislación y las consideraciones éticas que aporta la bioética.The prevalence of infertility in the Spanish population, estimated at 15 % of couples of childbearing age, and its progressive increase in recent years, has generated a strong increase in the demand for reproductive assistance techniques, which has doubled in the last 15 years the number of health centers offering one or more of these assisted reproduction techniques (ART). The demand no longer comes only from sterile couples in which surgical and medical therapeutic measures have failed, but other groups have been added that use the ART as the first option, which allows an increase in demand in the coming years, Coupled with the greater effectiveness of these techniques. However, these techniques are not exempt from serious controversy due to the strong legal and ethical problems they generate. These two aspects are the object of this work, analyzing the answers given by our legislation and the ethical considerations that bioethics contributes.Medicin

Estudio podobarométrico en gestantes

El embarazo produce una importante alteración postural en la mujer embarazada. Sin embargo, los cambios que ocurren durante las distintas fases de la marcha en el embarazo no se han evaluado adecuadamente en la literatura. Esta investigación transversal de las huellas plantares de 109 mujeres embarazadas revela un aumento significativo en la lordosis lumbar y un incremento del uso de los flexores plantares, extensores y abductores de la cadera. Todos estos cambios producen la aparición de exceso de pronación del medio y retropié. Respecto a la dinámica, apreciamos un aumento del tiempo de contacto con el suelo en la fase de apoyo, lo que provoca una progresiva ralentización de la cadencia de paso y una lateralización de la marcha. Estos cambios posturales constituyen un mecanismo de compensación para mejorar la estabilidad del aparato locomotor, y pueden tener importantes implicaciones en la función estática y dinámica de las extremidades inferiores, ya que se produce un aumento de la inclinación pélvica en el plano sagital. Las diferencias sugieren que las mujeres adaptan su patrón de marcha para aprovechar al máximo la estabilidad en la deambulación. Sería necesaria una mayor investigación para averiguar las complejas interrelaciones entre el pie y la función del miembro inferior y el embarazo, así como las posibilidades de intervención terapéutica ortésica.Pregnancy causes significant postural change in pregnant women. But the changes that occur during different phases of gait during pregnancy have not been properly assessed in literature. The research section of the traces of 109 pregnant women revealed a significant increase in lumbar lordosis, an increased use of plantar flexors, extensors and hip abductors all these changes produce the appearance of excessive rearfoot pronation medium with respect to the dynamics, we see an increase in contact time with the ground support phase, causing a progressive slowdown in the rate of passage and a lateralization of the march. These postural changes are a compensatory mechanism to improve the stability of the musculoskeletal system and may have important implications for static and dynamic function of the lower extremities, as is an increase of pelvic tilt in the sagittal plane. The differences suggest that women adapt their walking pattern to maximize stability in walking. Further research would be needed to determine the complex interrelationships between the foot and lower limb function and pregnancy, and the possibilities of therapeutic intervention orthotics.Podologí

Applying Challenge Based Learning to Teach Mass Transfer

[EN] In order to enhance undergraduates' understanding of mass transfer unit operations, Challenge-Based Learning (CBL) was applied in two courses on Transport Phenomena in the Food Industry. The courses are part of Agrifood Engineering Degree program at the Universitat Politecnica de Valencia (UPV). After the lecturers explained the topic to the fourth-year students, they were given the challenge of preparing and solving cases of mass transport phenomena dealing with solid-liquid extraction and food drying. Students were divided into six groups of three or four students; each group chose a product to work with, and each group designed a flowchart with the main stages of the process based on the information gathered from varied bibliographical sources. The corresponding mathematical models were applied to characterize the flow and estimate the performance and efficiency. After that, students wrote short reports of the main steps followed to complete the task. The reports were presented to a panel of expert lecturers to provide feedback and recommendations. Specifically designed rubrics were employed by the panel to assess the impact of the methodology on students' subject-specific skills in addition to collaborative work, problem solving, time management and oral presentation skills.This work was supported by the Universitat Politecnica de Valencia with the Grant PIME/20-21/208.Barrera Puigdollers, C.; Castelló Gómez, ML.; Seguí Gil, L.; Heredia Gutiérrez, AB.; García Hernández, J. (2022). Applying Challenge Based Learning to Teach Mass Transfer. INTERNATIONAL JOURNAL OF ENGINEERING EDUCATION. 38(1):171-180. http://hdl.handle.net/10251/186575S17118038

Eligibility criteria for Menopausal Hormone Therapy (MHT): a position statement from a consortium of scientific societies for the use of MHT in women with medical conditions. MHT Eligibility Criteria Group

This project aims to develop eligibility criteria for menopausal hormone therapy (MHT). The tool should be similar to those already established for contraception A consortium of scientific societies coordinated by the Spanish Menopause Society met to formulate recommendations for the use of MHT by women with medical conditions based on the best available evidence. The project was developed in two phases. As a first step, we conducted 14 systematic reviews and 32 metanalyses on the safety of MHT (in nine areas: age, time of menopause onset, treatment duration, women with thrombotic risk, women with a personal history of cardiovascular disease, women with metabolic syndrome, women with gastrointestinal diseases, survivors of breast cancer or of other cancers, and women who smoke) and on the most relevant pharmacological interactions with MHT. These systematic reviews and metanalyses helped inform a structured process in which a panel of experts defined the eligibility criteria according to a specific framework, which facilitated the discussion and development process. To unify the proposal, the following eligibility criteria have been defined in accordance with the WHO international nomenclature for the different alternatives for MHT (category 1, no restriction on the use of MHT; category 2, the benefits outweigh the risks; category 3, the risks generally outweigh the benefits; category 4, MHT should not be used). Quality was classified as high, moderate, low or very low, based on several factors (including risk of bias, inaccuracy, inconsistency, lack of directionality and publication bias). When no direct evidence was identified, but plausibility, clinical experience or indirect evidence were available, "Expert opinion" was categorized. For the first time, a set of eligibility criteria, based on clinical evidence and developed according to the most rigorous methodological tools, has been defined. This will provide health professionals with a powerful decision-making tool that can be used to manage menopausal symptoms

Obstetric–neonatal care during birth and postpartum in symptomatic and asymptomatic women infected with SARS-CoV-2: a retrospective multicenter study

This study analyses the obstetric–neonatal outcomes of women in labour with symptomatic and asymptomatic COVID-19. A retrospective, multicenter, observational study was carried out between 1 March 2020 and 28 February 2021 in eight public hospitals in the Valencian community (Spain). The chi-squared test compared the obstetric–neonatal outcomes and general care for symptomatic and asymptomatic women. In total, 11,883 births were assisted in participating centers, with 10.9 per 1000 maternities (n = 130) infected with SARS-CoV-2. The 20.8% were symptomatic and had more complications both upon admission (p = 0.042) and during puerperium (p = 0.042), as well as transfer to the intensive care unit (ICU). The percentage of admission to the Neonatal Intensive Care Unit (NICU) was greater among offspring of symptomatic women compared to infants born of asymptomatic women (p < 0.001). Compared with asymptomatic women, those with symptoms underwent less labour companionship (p = 0.028), less early skin-to-skin contact (p = 0.029) and greater mother–infant separation (p = 0.005). The overall maternal mortality rate was 0.8%. No vertical transmission was recorded. In conclusion, symptomatic infected women are at increased risk of lack of labour companionship, mother–infant separation, and admission to the ICU, as well as to have preterm births and for NICU admissions

Real-world effectiveness of caplacizumab vs the standard of care in immune thrombotic thrombocytopenic purpura

Immune thrombotic thrombocytopenic purpura (iTTP) is a thrombotic microangiopathy caused by anti-ADAMTS13 antibodies. Caplacizumab is approved for adults with an acute episode of iTTP in conjunction with plasma exchange (PEX) and immunosuppression. The objective of this study was to analyze and compare the safety and efficacy of caplacizumab vs the standard of care and assess the effect of the concomitant use of rituximab. A retrospective study from the Spanish TTP Registry of patients treated with caplacizumab vs those who did not receive it was conducted. A total of 155 patients with iTTP (77 caplacizumab, 78 no caplacizumab) were included. Patients initially treated with caplacizumab had fewer exacerbations (4.5% vs 20.5%; P <.05) and less refractoriness (4.5% vs 14.1%; P <.05) than those who were not treated. Time to clinical response was shorter when caplacizumab was used as initial treatment vs caplacizumab used after refractoriness or exacerbation. The multivariate analysis showed that its use in the first 3 days after PEX was associated with a lower number of PEX (odds ratio, 7.5; CI, 2.3-12.7; P <.05) and days of hospitalization (odds ratio, 11.2; CI, 5.6-16.9; P <.001) compared with standard therapy. There was no difference in time to clinical remission in patients treated with caplacizumab compared with the use of rituximab. No severe adverse event was described in the caplacizumab group. In summary, caplacizumab reduced exacerbations and refractoriness compared with standard of care regimens. When administered within the first 3 days after PEX, it also provided a faster clinical response, reducing hospitalization time and the need for PEX

Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01)

Altres ajuts: Agustí Barnadas: Honoraria: Pfizer. Consulting or Advisory Role: Pfizer, Novartis, Eli Lilly. Speakers'Bureau: Roche, Pfizer, Novartis, Genomic Health International. Travel, Accommodations, Expenses: Roche, Pfizer; Miguel A. Seguí: Consulting or Advisory Role: Roche, Pfizer, Novartis, Amgen, Eisai, Eli Lilly. Speakers' Bureau: Roche, Pfizer, Amgen. Research Funding: Roche (Inst), Novartis (Inst). Travel, Accommodations, Expenses: Roche, Pfizer, Novartis, Amgen.Operable triple-negative breast cancers (TNBCs) have a higher risk of relapse than non-TNBCs with standard therapy. The GEICAM/2003-11_CIBOMA/2004-01 trial explored extended adjuvant capecitabine after completion of standard chemotherapy in patients with early TNBC. Eligible patients were those with operable, node-positive-or node negative with tumor 1 cm or greater-TNBC, with prior anthracycline- and/or taxane-containing chemotherapy. After central confirmation of TNBC status by immunohistochemistry, patients were randomly assigned to either capecitabine or observation. Stratification factors included institution, prior taxane-based therapy, involved axillary lymph nodes, and centrally determined phenotype (basal v nonbasal, according to cytokeratins 5/6 and/or epidermal growth factor receptor positivity by immunohistochemistry). The primary objective was to compare disease-free survival (DFS) between both arms. Eight hundred seventy-six patients were randomly assigned to capecitabine (n = 448) or observation (n = 428). Median age was 49 years, 55.9% were lymph node negative, 73.9% had a basal phenotype, and 67.5% received previous anthracyclines plus taxanes. Median length of follow-up was 7.3 years. DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06; P =.136]. In a preplanned subgroup analysis, nonbasal patients seemed to derive benefit from the addition of capecitabine with a DFS HR of 0.53 versus 0.94 in those with basal phenotype (interaction test P =.0694) and an HR for overall survival of 0.42 versus 1.23 in basal phenotype (interaction test P =.0052). Tolerance of capecitabine was as expected, with 75.2% of patients completing the planned 8 cycles. This study failed to show a statistically significant increase in DFS by adding extended capecitabine to standard chemotherapy in patients with early TNBC. In a preplanned subset analysis, patients with nonbasal phenotype seemed to obtain benefit with capecitabine, although this will require additional validation

Real-world effectiveness of caplacizumab vs the standard of care in immune thrombotic thrombocytopenic purpura

Immune thrombotic thrombocytopenic purpura (iTTP) is a thrombotic microangiopathy caused by anti-ADAMTS13 antibodies. Caplacizumab is approved for adults with an acute episode of iTTP in conjunction with plasma exchange (PEX) and immunosuppression. The objective of this study was to analyze and compare the safety and efficacy of caplacizumab vs the standard of care and assess the effect of the concomitant use of rituximab. A retrospective study from the Spanish TTP Registry of patients treated with caplacizumab vs those who did not receive it was conducted. A total of 155 patients with iTTP (77 caplacizumab, 78 no caplacizumab) were included. Patients initially treated with caplacizumab had fewer exacerbations (4.5% vs 20.5%; P < .05) and less refractoriness (4.5% vs 14.1%; P < .05) than those who were not treated. Time to clinical response was shorter when caplacizumab was used as initial treatment vs caplacizumab used after refractoriness or exacerbation. The multivariate analysis showed that its use in the first 3 days after PEX was associated with a lower number of PEX (odds ratio, 7.5; CI, 2.3-12.7; P < .05) and days of hospitalization (odds ratio, 11.2; CI, 5.6-16.9; P < .001) compared with standard therapy. There was no difference in time to clinical remission in patients treated with caplacizumab compared with the use of rituximab. No severe adverse event was described in the caplacizumab group. In summary, caplacizumab reduced exacerbations and refractoriness compared with standard of care regimens. When administered within the first 3 days after PEX, it also provided a faster clinical response, reducing hospitalization time and the need for PEX

Las técnicas de reproducción humana asistida y su regulación legislativa española

The prevalence of infertility in the Spanish population, estimated at 15 % of couples of childbearing age, and its progressive increase in recent years, has generated a strong increase in the demand for reproductive assistance techniques, which has doubled in the last 15 years the number of health centers offering one or more of these assisted reproduction techniques (ART). The demand no longer comes only from sterile couples in which surgical and medical therapeutic measures have failed, but other groups have been added that use the ART as the first option, which allows an increase in demand in the coming years, Coupled with the greater effectiveness of these techniques. However, these techniques are not exempt from serious controversy due to the strong legal and ethical problems they generate. These two aspects are the object of this work, analyzing the answers given by our legislation and the ethical considerations that bioethics contributes. The regulations have varied greatly in the two decades since Law 35/1988 about ART, as amended by Law 45/2003, to Act 14/2006 about ART, with some clarification in the subsequent Law 2/2010 about reproductive health and voluntary abortion, trying to please on one hand the demand of citizenship and on the other to put limits to certain practices exaggeratedly out of every ethics.La prevalencia de esterilidad en la población española, estimada en un 15 % de las parejas en edad fértil, y su incremento progresivo en los últimos años han generado un fuerte aumento de la demanda de técnicas de asistencia a la reproducción que ha duplicado durante quince años el número de centros sanitarios que ofrecen una o varias de estas técnicas de reproducción humana asistida (TRHA). La demanda ya no procede solo de parejas estériles en las que han fracasado las medidas terapéuticas, quirúrgicas y médicas, sino que se han añadido otros colectivos que recurren a las TRHA como primera opción, lo que permite suponer un aumento de la demanda en los próximos años, unido a la mayor eficacia de estas técnicas. Sin embargo, estas técnicas no están exentas de graves controversias debido a los fuertes problemas legales y éticos que generan. Estos dos aspectos son el objeto de este trabajo, analizando las respuestas que da nuestra legislación y las consideraciones éticas que aporta la bioética.La normativa ha variado mucho durante dos décadas desde la Ley 35/1988 sobre TRHA, modificada por la Ley 45/2003, hasta la Ley 14/2006 sobre TRHA, con algunas aclaraciones en la posterior Ley 2/2010 de salud reproductiva y de IVE, intentando complacer, por un lado, la demanda de la ciudadanía y, por otro, poner límite a ciertas prácticas exageradamente fuera de toda ética

Estudio podobarométrico en gestantes

Pregnancy causes significant postural change in pregnant women. But the changes that occur during different phases of gait during pregnancy have not been properly assessed in literature. The research section of the traces of 109 pregnant women revealed a significant increase in lumbar lordosis, an increased use of plantar flexors, extensors and hip abductors all these changes produce the appearance of excessive rearfoot pronation medium with respect to the dynamics, we see an increase in contact time with the ground support phase, causing a progressive slowdown in the rate of passage and a lateralization of the march. These postural changes are a compensatory mechanism to improve the stability of the musculoskeletal system and may have important implications for static and dynamic function of the lower extremities, as is an increase of pelvic tilt in the sagittal plane. The differences suggest that women adapt their walking pattern to maximize stability in walking. Further research would be needed to determine the complex interrelationships between the foot and lower limb function and pregnancy, and the possibilities of therapeutic intervention orthotics.El embarazo produce una importante alteración postural en la mujer embarazada. Sin embargo, los cambios que ocurren durante las distintas fases de la marcha en el embarazo no se han evaluado adecuadamente en la literatura. Esta investigación transversal de las huellas plantares de 109 mujeres embarazadas revela un aumento significativo en la lordosis lumbar y un incremento del uso de los flexores plantares, extensores y abductores de la cadera. Todos estos cambios producen la aparición de exceso de pronación del medio y retropié. Respecto a la dinámica, apreciamos un aumento del tiempo de contacto con el suelo en la fase de apoyo, lo que provoca una progresiva ralentización de la cadencia de paso y una lateralización de la marcha. Estos cambios posturales constituyen un mecanismo de compensación para mejorar la estabilidad del aparato locomotor, y pueden tener importantes implicaciones en la función estática y dinámica de las extremidades inferiores, ya que se produce un aumento de la inclinación pélvica en el plano sagital. Las diferencias sugieren que las mujeres adaptan su patrón de marcha para aprovechar al máximo la estabilidad en la deambulación. Sería necesaria una mayor investigación para averiguar las complejas interrelaciones entre el pie y la función del miembro inferior y el embarazo, así como las posibilidades de intervención terapéutica ortésica