Detecció precoç personalitzada del càncer de mama i utilitat de les eines d’ajuda a les decisions

El càncer de mama és una de les principals causes de morbimortalitat en el món. En la major part dels països europeus el cribratge del càncer de mama en dones de la població general es basa en l'edat, però hi ha altres factors de risc que donen lloc a una gran variabilitat en el risc del càncer de mama. Per poder oferir un cribratge personalitzat és necessari estimar el risc individual de les dones i oferir-los, en funció d'aquest, l’estratègia més adequada de cribratge segons l'evidència disponible. Per poder realitzar un cribratge personalitzat és fonamental que les dones coneguin els riscos i beneficis del cribratge, d'aquí la importància de les eines d'ajuda a la decisió (EAD). És per aquest motiu que el primer article de la tesi és una revisió sistemàtica per avaluar l'evidència sobre l'efecte de les EAD en el cribratge del càncer de mama. Per avaluar l'efecte d'utilitzar una EAD vam dur a terme l'estudi InforMa, dissenyat pel grup de recerca al que em vaig incorporar per realitzar aquesta tesi. Aprofitant la informació recollida en aquest estudi vam elaborar el segon article de la tesi que avaluava si el nivell educatiu modifica l'efecte de l’EAD en el coneixement i en la presa de decisions sobre el cribratge. Posteriorment, vam elaborar el protocol de l'estudi DECIDO que té per objectiu avaluar la viabilitat, l’acceptabilitat i la integració en la pràctica clínica del cribratge personalitzat del càncer de mama. L'Atenció Primària, és la porta d'entrada al Sistema Nacional de Salut. Per això, hem considerat important elaborar un article divulgatiu adreçat als professionals d’Atenció Primària, que és la quarta publicació de les que es presenten com a part d’aquesta tesi, amb l’objectiu de difondre l'estat actual de l'evidència sobre el cribratge personalitzat, així com els resultats dels estudis que hem desenvolupat. A més d’obrir camí cap al cribratge personalitzat del càncer de mama, aquesta tesi també ha pretès fer palesa la importància que les dones siguin també responsables de les seves decisions i fomentar d'aquesta manera la presa de decisions compartides.El cáncer de mama es una de las principales causas de morbimortalidad en el mundo. En la mayor parte de los países europeos, el cribado del cáncer de mama en mujeres de la población general se basa en la edad, pero existen otros factores de riesgo que dan lugar a una gran variabilidad en el riesgo del cáncer de mama. Para poder ofrecer un cribado personalizado es necesario estimar el riesgo individual de las mujeres y ofrecerles, en función de éste, la estrategia más adecuada de cribado según la evidencia disponible. Para poder realizar un cribado personalizado es fundamental que las mujeres conozcan los riesgos y beneficios del cribado, de ahí la importancia de las herramientas de ayuda en la toma de decisión (HATD). Por este motivo, el primer artículo de la tesis es una revisión sistemática, para evaluar la evidencia sobre el efecto de las HATD en el cribado del cáncer de mama. Para evaluar el efecto de utilizar una HATD llevamos a cabo el estudio InforMa, diseñado por el grupo de investigación al que me incorporé para realizar esta tesis. Aprovechando la información recogida en este estudio elaboramos el segundo artículo de la tesis, que evaluaba si el nivel educativo modifica el efecto de la HATD en el conocimiento y en la toma de decisiones sobre el cribado. Posteriormente, elaboramos el protocolo del estudio DECIDO que tiene por objetivo evaluar la viabilidad, la aceptabilidad y la integración en la práctica clínica del cribado personalizado del cáncer de mama. La Atención Primaria es la puerta de entrada al Sistema Nacional de Salud. Por eso, hemos considerado importante elaborar un artículo divulgativo dirigido a los profesionales de Atención Primaria, que es la cuarta publicación de las que se presentan como parte de esta tesis, con el objetivo de difundir el estado actual de la evidencia sobre el cribado personalizado, así como los resultados de los estudios que hemos desarrollado. Además de abrir el camino hacia el cribado personalizado, esta tesis también ha pretendido poner de manifiesto la importancia de que las mujeres sean también responsables de sus decisiones y fomentar de este modo la toma de decisiones compartidas.Breast cancer is one of the leading causes of morbidity and mortality in the world. In most European countries, breast cancer screening in women in the general population is based on age, but there are other risk factors that lead to great variability in breast cancer risk. In order to be able to offer personalized screening, it is necessary to estimate the individual risk of breast cancer and offer, based on this, the most appropriate screening strategy according to the available evidence. In order to perform personalized screening properly, it is essential that women know the benefits and harms of screening, hence the importance of decision aids (DA). It is for this reason that the first article of the thesis is a systematic review to evaluate the evidence on the effect of DA on breast cancer screening. To evaluate the effect of using a DA we conducted the InforMa study, designed by the research group I joined as a PhD candidate. Using the information collected in this study, we elaborated the second article of the thesis that assessed whether the level of education modifies the effect of DA on knowledge and decision-making on screening. Afterwards, wedeveloped the DECIDO study protocol, a study that aims to assess the feasibility, acceptability, and integration into the clinical practice of personalized breast cancer screening. Primary Care is the gateway to the National Health System. For this reason, we have considered it important to write a special article addressed to Primary Care professionals, which is the fourth publication of those presented as part of this thesis, with the aim of disseminating the current state of evidence on personalized screening, as well as the results of the studies we have performed. While paving the way for personalized breast cancer screening, this thesis has also sought to highlight the importance of women also being responsible for their decisions and thus encouraging shared decision-making

Perspectiva de género en profesionales de la salud durante la pandemia de COVID-19

Introduction. The COVID-19 pandemic has brought about a health crisis with a strong social impact, largely derived from population confinement policies. Previous studies have highlighted the gender inequalities that pandemics generate. Objective. This research aims to identify the impact of the COVID-19 pandemic on health professionals with a gender perspective in aspects related to their work, family, and social spheres. Material and method. The study is descriptive exploratory, with a cross-sectional quantitative research methodology. The instrument for data collection is a structured questionnaire administered by email. A descriptive analysis of the main characteristics of the participants according to gender is performed. Results. The results of the study point to the existence of inequalities between health professionals, determined by gender, in reference to participation in decision-making, the different burden of care tasks, the impact on emotional aspects and perceptions about what supposes the pandemic for men and women. Conclusions. The role of women must be taken into account in the management of pandemics. Women should be especially involved in decision-making in healthcare to deal with the social and emotional consequences that affect health professionals, and which derive from the care burden and the lack of co-responsibility in the provision of care.Introducción. La pandemia de COVID-19 ha generado una crisis sanitaria con un contundente impacto social, derivado en gran medida de las políticas de confinamiento de la población. Estudios anteriores han puesto en evidencia las desigualdades de género que generan las pandemias. Objetivo. Esta investigación tiene como objetivo identificar el impacto de la pandemia de la COVID-19 en profesionales de la salud desde perspectiva de género, en aspectos de la esfera profesional, familiar y social. Material y método. El estudio es de tipo exploratorio descriptivo, con una metodología de investigación cuantitativa transversal. El instrumento para la recogida de los datos es un cuestionario estructurado administrado por correo electrónico. Se realiza un análisis descriptivo de las principales características de las personas participantes según el género. Resultados. Los resultados del estudio apuntan a la existencia de desigualdades entre profesionales de la salud, determinadas por el género, en referencia a la participación en la toma de decisiones, la diferente carga que suponen las tareas de cuidado, el impacto en aspectos emocionales y percepciones sobre lo que supone la pandemia para hombres y mujeres. Conclusiones. El papel de la mujer debe ser tenido en cuenta en la gestión de las pandemias. Especialmente debe implicarse a las mujeres en la toma de decisiones en el ámbito de la salud para tratar aspectos relacionados con el abordaje sanitario, así como las consecuencias sociales y emocionales que afectan a las profesionales derivadas de la carga asistencial y la falta de corresponsabilidad en los cuidados

Informed choice in breast cancer screening: the role of education

[spa ] Objetivo: Evaluar el efecto de recibir información sobre los beneficios y los efectos adversos del cribado del cáncer de mama en la elección informada, en función del nivel educativo. Método: Análisis secundario de un estudio experimental aleatorizado y controlado, en cuatro programas de cribado en Cataluña˜ y Canarias. Se analizaron 400 mujeres que iban a ser invitadas a participar por primera vez. El grupo de intervención recibió una herramienta informativa que mostraba los beneficios y los efectos adversos del cribado. El grupo control recibió un folleto estándar que recomendaba participar en el cribado. El nivel de estudios se agrupó en dos categorías: bajo y alto. La variable principal fue la elección informada definida como un conocimiento adecuado y la concordancia entre las actitudes y las intenciones. Resultados: La intervención produjo un mayor aumento del conocimiento en las mujeres con nivel educativo alto respecto a las de menor nivel educativo. Entre las mujeres que recibieron la intervención, la elección informada fue casi tres veces superior en las de nivel educativo alto (27% vs. 11%). No se observaron diferencias entre niveles educativos en los grupos de intervención y control en cuanto a conflicto decisional, confianza en la decisión, ansiedad y preocupación por el cáncer de mama. Conclusiones: Una herramienta informativa para el cribado del cáncer de mama tuvo mucho más impacto sobre la elección informada en las mujeres con nivel educativo alto. En aquellas con nivel educativo bajo mejoró la actitud frente al cribado y produjo un aumento en la intención de participar en él. [eng] Conclusions: A decision aid for breast cancer screening had much more impact on informed choice among women with a high educational level. In women with low educational level, the attitude towards screening improved and there was an increase in the intention to be screened. Objective: To evaluate the effect of receiving information about the benefits and harms of breast cancer screening in informed choice, according to educational level. Method: Secondary analysis of a randomized, controlled study, in four screening programs, in Catalonia and the Canary Islands (Spain). We analyzed 400 women who were going to be invited to participate for the first time. The intervention group received a decision aid that showed the benefits and harms of screening. The control group received a standard brochure that recommended participating in the screening program. Educational level was grouped into two categories, low and high. The primary out- come was informed choice defined as adequate knowledge and consistency between attitudes and intentions. Results: The intervention produced a greater increase in knowledge in women with a high educational level compared to those with a lower educational level. Among women who received the intervention, informed choice was almost three times higher in those with a high educational level (27% versus 11%). No differences were observed between educational levels in decisional conflict, confidence in the decision, anxiety and worry about breast cancer, in the intervention and control groups

Assessment of the effects of decision aids about breast cancer screening: a systematic review and meta-analysis

Objective: The aim of this systematic review and meta-analysis of randomised controlled trials (RCTs) and observational studies is to assess the effect of decision aids (DAs) in women aged 50 and below facing the decision to be screened for breast cancer. Setting: Screening for breast cancer. Intervention: DAs aimed to help women make a deliberative choice regarding participation in mammography screening by providing information on the options and outcomes. Eligible studies: We included published original, non-pilot, studies that assess the effect of DAs for breast cancer screening. We excluded the studies that evaluated only participation intention or actual uptake. The studies' risk of bias was assessed with the Cochrane Collaboration's tool for RCTs and the National Institutes of Health Quality Assessment Tool for non-RCTs. Primary and secondary outcomes: The main outcome measures were informed choice, decisional conflict and/or confidence, and knowledge. Secondary outcomes were values, attitudes, uncertainty and intention to be screened. Results: A total of 607 studies were identified, but only 3 RCTs and 1 before-after study were selected. The use of DAs increased the proportion of women making an informed decision by 14%, 95% CI (2% to 27%) and the proportion of women with adequate knowledge by 12%, 95% CI (7% to 16%). We observed heterogeneity among the studies in confidence in the decision. The meta-analysis of the RCTs showed a significant decrease in confidence in the decision and in intention to be screened. Conclusions: Tools to aid decision making in screening for breast cancer improve knowledge and promote informed decision; however, we found divergent results on decisional conflict and confidence in the decision. Under the current paradigm change, which favours informed choice rather than maximising uptake, more research is necessary for the improvement of DAs

Actuacions dels veterinaris oficials en cas d'avaria d'una línia de porcí

Slaugtherhouse; Official control; Meat inspectionEscorxador; Control oficial; Inspecció de carnsMatadero; Control oficial; Inspección de carnesEl veterinari o veterinària oficial d’escorxador (VOE), davant d’una avaria a la línia de sacrifici de porcí, ha de dictaminar l’aptitud o no per al consum humà de les canals, tenint en compte dos punts: 1. La valoració de les actuacions específiques dutes a terme en aquest sentit per part de l’operador o operadora de l’empresa alimentària (OEA), que hauria de tenir previstes aquesta mena de situacions dins el seu pla d’autocontrols. 2. La inspecció post mortem de les carns afectades. Aquest treball pretén analitzar diversos supòsits que poden aparèixer durant una avaria a les possibles línies d’un escorxador de porcí, i que donen com a conseqüència una manipulació tardana i/o atípica de les carns (respecte a les condicions normals d’obtenció de les carns de cada escorxador).El veterinario o veterinaria oficial de matadero (VOE), ante una avería en la línea de sacrificio de porcino, debe dictaminar la aptitud o no para el consumo humano de las canales, teniendo en cuenta dos puntos: 1. La valoración de las actuaciones específicas llevadas a cabo en este sentido por parte del operador u operadora de la empresa alimentaria (OEA), que debería tener previstas este tipo de situaciones dentro de su plan de autocontroles. 2. La inspección post mortem de las carnes afectadas. Este trabajo pretende analizar varios supuestos que pueden aparecer durante una avería en las posibles líneas de un matadero de porcino, y que dan como consecuencia una manipulación tardía y/o atípica de las carnes (respecto a las condiciones normales de obtención de las carnes de cada matadero).The official slaughterhouse veterinarian (VOE), in the event of a breakdown in the pig slaughter line, must rule on the aptitude or not for human consumption of the carcasses, taking into account two points: 1. The assessment of the specific actions carried out in this sense by the operator or operator of the food company (OEA), which should have foreseen this type of situation within its self-control plan. 2. Post-mortem inspection of the affected meats. This work intends to analyze several assumptions that can appear during a breakdown in the possible lines of a pig slaughterhouse, and that result in a late and/or atypical handling of the meats (with respect to the normal conditions for obtaining the meats of each slaughterhouse)

Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg) : A structured summary of a study protocol for a randomised placebo controlled trial

Objectives: The primary objectives of the study are: 1. To assess the effect of hydroxychloroquine (HCQ) in reducing SARS-CoV-2 viral shedding by PCR in infected pregnant women with mild symptoms. 2. To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case. 3. To evaluate the effect of HCQ in preventing the development of the COVID-19 disease in asymptomatic SARS-CoV-2-infected pregnant women. The secondary objectives are: 1. To determine the effect of HCQ on the clinical course and duration of the COVID-19 disease in SARS-CoV-2-infected pregnant women. 2. To determine the impact of HCQ on the risk of hospitalization and mortality of SARS-CoV-2-infected pregnant women. 3. To assess the safety and tolerability of HCQ in pregnant women. 4. To describe the clinical presentation of SARS-CoV-2 infection during pregnancy. 5. To describe the effects of maternal SARS-CoV-2 infection on pregnancy and perinatal outcomes by treatment group. 6. To determine the risk of vertical transmission (intra-utero and intra-partum) of SARS-CoV-2. Trial design: Randomized double-blind placebo-controlled two-arm multicentre clinical trial to evaluate the safety and efficacy of HCQ to prevent and/or minimize SARS-CoV-2 infection during pregnancy. Participants will be randomized to receive a 14-day oral treatment course of HCQ or placebo, ratio 1:1. Participants: Study population: pregnant women undergoing routine prenatal follow up or attending emergency units at the participating hospitals who report either symptoms/signs suggestive of COVID-19 disease or close contact with a suspected or confirmed COVID-19 case. Inclusion criteria Women will be invited to participate in the trial and sign an informed consent if they meet the following inclusion criteria. •Presenting with fever (≥37.5°C) and/or one mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, dysgeusia, headache) OR being contact*of a SARS-CoV-2 confirmed or suspected case in the past 14 days •More than 12 weeks of gestation (dated by ultrasonography) •Agreement to deliver in the study hospitals Exclusion criteria •Known hypersensitivity to HCQ or other 4-amonoquinoline compounds •History of retinopathy of any aetiology •Concomitant use of digoxin, cyclosporine, cimetidine •Known liver disease •Clinical history of cardiac pathology including known long QT syndrome •Unable to cooperate with the requirements of the study •Participating in other intervention studies •Delivery onset (characterized by painful uterine contractions and variable changes of the cervix, including some degree of effacement and slower progression of dilatation up to 5 cm for first and subsequent labours) The study participants will be stratified by clinical presentation and SARS-CoV-2 PCR results. Assignment of participants to study groups will be as follows: •SARS-CoV-2-PCR confirmed, infected pregnant women: a. symptomatic (n=100) b. asymptomatic (n=100) •SARS-CoV-2 PCR negative pregnant women in contact*with a SARS-CoV-2-infected confirmed or suspected case (n=514).*The ECDC definition of close contact will be followed. The trial will be conducted in five hospitals in Spain: Hospital Clínic of Barcelona, Hospital Sant Joan de Déu and Hospital de la Santa Creu i Sant Pau, in Barcelona, and HM Puerta del Sur and Hospital Universitario de Torrejón, in Madrid. Intervention and comparator: Participants will be randomized to HCQ (400 mg/day for three days, followed by 200 mg/day for 11 days) or placebo (2 tablets for three days, followed by one tablet for 11 days). Main outcomes: The primary outcome is the number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start (one week after treatment is completed). Randomisation: Allocation of participants to study arms will be done centrally by the trial's Sponsor (the Barcelona Institute for Global Health, ISGlobal) by block randomization. This method will ensure balanced allocation to both arms. The electronic CRF will automatically assign a study number to each participant, depending on her study group and recruitment site. Each number will be related to a treatment number, which assigns them to one of the study arms. Blinding (masking): Participants, caregivers, investigators and those assessing the outcomes will be blinded to group assignment. Study tablets (HCQ and placebo) will be identically packaged in small opaque bottles. Numbers to be randomised (sample size): This study requires 200 SARS-CoV-2 infected and 514 contact pregnant women, randomised 1:1 with 100 and 227 respectively in each study arm. Trial Status: Protocol version 1.0, from May 8th, 2020. Recruitment is ongoing (first patient recruited the 19th May 2020 and recruitment end anticipated by December 2020). Trial registration: EudraCT number: 2020-001587-29, registered 2 April 2020. Clinicaltrials.gov identifier: NCT04410562, retrospectively registered 1 June 2020. Full protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol

Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study.

Participation of pregnant women in clinical trials entails challenges mainly related to concerns about the risks for fetuses. We undertook a qualitative study from June to October 2020 to assess the acceptability of participating in COVID-19 clinical trials among pregnant women in Spain. Phenomenology and grounded theory were used as methodological approaches. Semi-structured interviews were conducted with 24 pregnant women and six healthcare providers. Women were unsure if pregnancy was a risk factor to acquire the infection or to develop severe disease and expressed the limited information they had received, which led to uncertainties and emotional suffering. They had concerns regarding participation in clinical trials on COVID-19, regardless of the drug under study. Healthcare providers alluded to the importance of involving pregnant women’s relatives at the recruitment visit of the clinical trial. These findings may be useful to facilitate pregnant women’s participation in clinical trials.post-print599 K

Prevalence, features and predictive factors of liver nodules in Fontan surgery patients: The VALDIG Fonliver prospective cohort

Background & Aims: Fontan surgery is used to treat a variety of congenital heart malformations, and may lead to advanced chronic liver disease in the long-term. This study examines the prevalence, characteristics and predictors of liver nodules in patients following Fontan surgery. Methods: This was a prospective, cross-sectional, observational study conducted at 8 European centres. Consecutive patients who had undergone Fontan surgery underwent blood tests, abdominal ultrasonography (US), transient elastography (Fibroscan®), echocardiography, haemodynamic assessments, and abdominal MRI/CT scan. The primary outcome measure was liver nodules detected in the MRI/CT scan. Predictors of liver nodules were identified by multivariate logistic regression. Results: One hundred and fifty-two patients were enrolled (mean age 27.3 years). The mean time elapsed from surgery to inclusion was 18.3 years. Liver nodule prevalences were 29.6% (95% CI 23–37%) on US and 47.7% (95% CI 39–56%) on MRI/CT. Nodules were usually hyperechoic (76.5%), round-shaped (>80%), hyperenhancing in the arterial phase (92%) and located in the liver periphery (75%). The sensitivity and specificity of US were 50% (95% CI 38–62%) and 85.3% (95% CI 75–92%), respectively. Inter-imaging test agreement was low (adjusted kappa: 0.34). In the multivariate analysis, time since surgery >10 years was the single independent predictor of liver nodules (odds ratio 4.18; p = 0.040). Hepatocellular carcinoma was histologically diagnosed in 2 of the 8 patients with hypervascular liver nodules displaying washout. Conclusion: While liver nodules are frequent in Fontan patients, they may go unnoticed in US. Liver nodules are usually hyperechoic, hypervascular and predominantly peripheral. This population is at risk of hepatocellular carcinoma, the diagnosis of which requires confirmatory biopsy