Derechos y deberes de información: el rol de la atención primaria de salud en la implementación de la ley que despenaliza la interrupción voluntaria del embarazo en tres causales en Chile / Drets i deures d'informació: el rol de l'atenció primària de salut en la implementació de la llei que despenalitza la interrupció voluntària de l'embaràs en tres causals a Xile / The right to information: The role of Primary Health Care in theimplementation of the Abortion Law in Chile

Este artículo presenta los resultados de una investigación cualitativa que indagasobre la implementación de la ley de interrupción del embarazo que despenalizó elaborto en tres causales específicas en Chile en 2017 (Ley 21.030) y el rol que laatención primaria de salud (APS) en la Región Metropolitana de Chile. Serealizaron 19 entrevistas a personal de la salud de la APS y del nivel secundariode atención en la Región Metropolitana además de dos personas del Ministerio deSalud.El cambio de régimen de penalización total a uno de despenalización por causalesexige capacitación a los equipos de salud e información a la población. Loshallazgos revelan que la falta de información y capacitación formal al personalsanitario constituye un obstáculo para el ejercicio de los derechos de las mujeresque otorga la ley, produciéndose un efecto cascada, en que las mujeres nocuentan con la información suficiente para ejercer sus derechos. A ello se suma,una disposición en la ley que produce confusión entre profesionales sobrepublicidad e información sobre los servicios. Se analizan los resultados a partir deestándares normativos nacionales e internacionales respecto a la obligación deinformar, y el derecho a ser informado en contexto de prestaciones sanitarias relativas al aborto.(AU)

Es va realitzar un estudi exploratori a través d'una enquesta a Comitès d'Ètica a països d'Amèrica Llatina i el Carib de parla hispana, per rellevar la seva situació davant d'emergències sanitàriesi consultar els dilemes ètics enfrontats a les investigacions per a COVID-19. S'obtingueren respostes de 106 comitès, pertanyents a 14 països. Només el 24% va respondre que existia una xarxa de comunicació eficient i efectiva entre comitès, prèvia a la pandèmia. El 45% va respondre que no existien a la seva regió comitès específics per avaluar projectes vinculats a emergències sanitàries amb anterioritat a la pandèmia. El percentatge de CEI que disposava de procediments previs per avaluar investigacions ensituacions d'emergències sanitàries va ser només de 7%, si bé el 52% estava en procés d'elaboració arran de la pandèmia. El percentatge de CEI que va considerar raonable un temps inferior a 5 dies per a l'avaluació de projectes de recerca va variar en virtut del disseny: 32% per als estudis observacionals i 12% per als assaigs clínics amb drogues o amb vacunes.Els tres problemes ètics principals identificats als estudis per a COVID van estar relacionats amb el consentiment informat, els aspectes metodològics i la poca informació prèvia o manca d'evidència per als productes de recerca. Considerem que cal reformular la manera de pensar els problemes ètics de les emergències cap a un abordatge global, amb un enfocament preventiu, on les xarxes de col·laboració entre els CEI haurien de convertir-se en regla.(AU)

This article presents the results of a qualitative research that inquiriesabout theimplementation of the law on termination of pregnancy that decriminalized abortionon three specific grounds in Chile in 2017 (Law 21.030) and the role of primaryhealth care (PHC) in the Metropolitan Region of Chile. Nineteen interviews wereconducted with PHC and secondary level of care health professionals in addition totwo officials from the Ministry of Health. The change from a regime of totalcriminalization to one of decriminalization by cause requires training for healthteams and information for the population.The findings reveal that the lack ofinformation and formal training for health personnel constitutes an obstacle to theexercise of women's rights under the law, producing a cascade effect in whichwomen do not have sufficient information to exercise their rights. In addition, thereis a provision in the law that causes confusion among professionals aboutadvertising and information on services.The results are analyzed on the basis ofnational and international normative standards regarding the obligation to informand the right to be informed in the context of health services related to abortion.(AU)

Aula invertida a distancia vs. aula invertida convencional: un estudio comparativo

Introducción: en este estudio se exploraron los efectos del Aula invertida convencional (componente virtual para estudio independiente + componente presencial para discusión interactiva de casos clínicos) y del Aula invertida a distancia (componente virtual para estudio independiente + componente "en línea" para discusión interactiva de casos clínicos) implementada como estrategia de enseñanza/aprendizaje ante la pandemia por el COVID-19 para el aprendizaje autodirigido de los estudiantes de cirugía. Métodos: se compararon los niveles de aprendizaje autodirigido de un grupo de estudiantes de pregrado como indicador del resultado del cambio de estrategia metodológica en los participantes en un aula convencional en el 2017, contra los de un grupo de estudiantes partícipes en un aula invertida a distancia en el 2020, esto se hizo durante la asignatura Cirugía en la Universidad de la Sabana, en Chía, Colombia. Se utilizó para ello la Escala de preparación para el aprendizaje autodirigido (EPAD), traducida al español. Resultados: no se identificó un efecto importante (positivo o negativo) de ninguno de los dos modelos del aula invertida sobre el aprendizaje autodirigido (D de Cohen = -0,08; IC 95 % -0,42-0,24), con unos niveles aceptables del mismo en ambos grupos. Conclusiones: el Aula invertida a distancia es una alternativa al Aula invertida convencional que no compromete el aprendizaje autodirigido de los estudiantes de cirugía.

SUMMARY Introduction: In this study were compared the effects of the Conventional Flipped Classroom (virtual component for independent study + face-to-face component for the interactive discussion of clinical cases) and the Remote Flipped Classroom (FRFC) (virtual component for independent study + "online" component for the interactive discussion of clinical cases), as a teaching / learning strategy in the face of the COVID- 19 pandemic, on the self-directed learning of surgical students. Methods: Self-directed learning levels, as a result indicator of the change in methodological strategy, were compared in a group of undergraduate students participating in a conventional flipped classroom in 2017 to those of a group of students participating in a remote flipped classroom in 2020, during the surgery course at the Universidad de La Sabana, in Chía - Colombia. For this purpose, the Preparedness Scale for Self-Directed Learning (EPAD), validated to the Spanish language, was used. Results: In both groups, the levels of self-directed learning were acceptable. No significant effect (positive or negative) of either of the two models of flipped classroom was identified on the self-directed learning (d Cohen = -0.08; IC95% -0.42 - 0.24). Conclusions: The remote flipped classroom is an alternative to the conventional inverted classroom that does not compromise the self-directed learning of surgery students.

Kidney Transplants in Controlled Donation Following Circulatory Death, or Maastricht Type III Donors, With Abdominal Normothermic Regional Perfusion, Optimizing Functional Outcomes.

BACKGROUND: Warm ischemia time and ischemia-reperfusion damage result in higher rates of delayed graft function and primary nonfunction in kidney transplants (KTs) from controlled donation after circulatory death (cDCD). This study aimed to assess early and late kidney function and patient and graft survival of KT from cDCD preserved with normothermic regional perfusion (NRP) and to compare with KT from brain death donors (DBDs) and cDCD preserved with rapid recovery (RR). METHODS: Patients who received a KT at our institution from 2012 to 2018 were included, with a minimum follow-up period of 1 y. They were categorized by donor type and conditioning methods: DBD, cDCD with NRP, and cDCD with RR. Early and late graft function, along with patient and graft survival were analyzed in all groups. RESULTS: A total of 182 KT recipients were included in the study (98 DBD and 84 cDCD). Out of the cDCDs, 24 kidneys were recovered with the use of NRP and 62 with RR; 22 of the 24 kidneys were ultimately transplanted. The cDCD using NRP group showed lower rates of delayed graft function compared with the cDCD with RR group (36.3% versus 46.7%, P = 0.01). Also, primary nonfunction rates were lower in the cDCD using NRP group (4.5% versus 6.4% cDCD-RR and 10.2% DBD). Patient survival rates were >90% in all groups. No differences were found in graft survival rates at 1 y. CONCLUSIONS: The use of abdominal NRP improves early function recovery of KT from cDCD, making their outcomes comparable with those of DBD.

Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: 1. To assess the efficacy of Mesenchymal Stromal Cells (MSC) versus a control arm as described in the primary endpoint. 2. To evaluate the effects of MSC on the secondary efficacy endpoints. 3. To evaluate the safety and tolerability profiles of MSC. 4. To study soluble and cellular biomarkers that might be involved in the course of the disease and the response to the investigational product. TRIAL DESIGN: A double-blind, randomized, controlled, trial to evaluate the efficacy and safety of MSC intravenous administration in patients with COVID-induced Acute Respiratory Distress Syndrome (ARDS) compared to a control arm. PARTICIPANTS: The trial is being conducted at a third level hospital, Hospital Universitario Puerta de Hierro, in Majadahonda, Madrid (Spain). Inclusion criteria 1. Informed consent prior to performing study procedures (witnessed oral consent with written consent by representatives will be accepted to avoid paper handling). Written consent by patient or representatives will be obtained whenever possible. 2. Adult patients ≥18 years of age at the time of enrolment. 3. Laboratory-confirmed SARS-CoV-2 infection as determined by Polymerase Chain Reaction (PCR), in oropharyngeal swabs or any other relevant specimen obtained during the course of the disease. Alternative tests (e.g., rapid antigen tests) are also acceptable as laboratory confirmation if their specificity has been accepted by the Sponsor. 4. Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 96 hours at the time of randomization. 5. Patients requiring invasive ventilation are eligible within 72 hours from intubation. 6. Eligible for ICU admission, according to the clinical team. Exclusion criteria 1. Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team). 2. "Do Not Attempt Resuscitation" order in place. 3. Any end-stage organ disease or condition, which in the investigator's opinion, makes the patient an unsuitable candidate for treatment. 4. History of a moderate/severe lung disorder requiring home-based oxygen therapy. 5. Patient requiring Extracorporeal Membrane Oxygenation (ECMO), haemodialysis or hemofiltration at the time of treatment administration. 6. Current diagnosis of pulmonary embolism. 7. Active neoplasm, except carcinoma in situ or basalioma. 8. Known allergy to the products involved in the allogeneic MSC production process. 9. Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrolment). 10. Current participation in a clinical trial with an experimental treatment for COVID-19 (the use of any off-label medicine according to local treatment protocols is not an exclusion criteria). 11. Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial. INTERVENTION AND COMPARATOR: - Experimental treatment arm: Allogeneic MSC (approximately 1 x 106 cells/kg). - Control arm: placebo solution (same composition as the experimental treatment, without the MSC). One single intravenous dose of the assigned treatment will be administered on Day 0 of the study. All trial participants will receive standard of care (SOC). In the context of the current worldwide pandemic, SOC can include medicines that are being used in clinical practice (e.g. lopinavir/ritonavir; hydroxy/chloroquine, tocilizumab, etc.), as well as those authorised for COVID (e.g., remdesivir). MAIN OUTCOMES: Primary endpoint: Change in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration, or to the last available PaO2/FiO2 ratio if death occurs before day 7. Secondary endpoints: - All-cause mortality on days 7, 14, and 28 after treatment. - PaO2/FiO2 ratio at baseline and days 2, 4, 7, 14 and 28 after treatment. - Oxygen saturation (by standardized measurement) at baseline, daily until day 14, and on day 28 after treatment. - Time to PaO2/FiO2 ratio greater than 200 mmHg. - Subjects' clinical status on the WHO 7-point ordinal scale at baseline, daily until day 14, and on day 28 after treatment. - Time to an improvement of one category from admission on the WHO 7-point ordinal scale. - Percentage of patients that worsen at least one category on the WHO 7-point ordinal scale. - Percentage of patients that improve at least one category (maintained 48h) on the WHO 7-point ordinal scale. - Sequential Organ Failure Assessment (SOFA) scale at baseline and days 2, 4, 7, 14 and 28 after treatment. - Duration of hospitalization (days). - Duration of ICU stay (days). - Oxygen therapy-free days in the first 28 days after treatment. - Duration of supplemental oxygen. - Incidence of and duration of non-invasive and invasive mechanical ventilation in the first 28 days after treatment. - Mechanical ventilation-free days in the first 28 days after treatment. - Ventilation parameters. - Incidence of new onset pulmonary fibrosis at 3 and 12 months after treatment, based on CT scan and pulmonary function tests. - Survival at 3 and 12 months. - Cumulative incidence of Serious Adverse events (SAEs) and Grade 3 and 4 Adverse Events (AEs). - Cumulative incidence of Adverse Drug Reactions (ADR) in the experimental treatment arm. - Cumulative incidence of AEs of special interest. - Levels of analytical markers (C-Reactive Protein, lymphocyte and neutrophil counts, lymphocyte subpopulations, LDH, ferritin, D-dimer, coagulation tests and cytokines...) at baseline and days 2, 4, 7, 14 and 28 after treatment. - Other soluble and cellular biomarkers that might be involved in the course of the disease and the response to MSC. RANDOMISATION: The assignment to treatment will be carried out randomly and blinded, with a 1:1 allocation. Randomization will be done through a centralized system embedded in the electronic Case Report Form (CRF). BLINDING (MASKING): To ensure blinding, treatments will be prepared for administration at the Cell Production Unit and the administration of the treatment will be masked, not allowing the identification of the Investigational Medicinal Product (IMP). NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 20 participants are planned to be randomized, 10 to each treatment group. TRIAL STATUS: Protocol version: 1.2, dated October 14th, 2020 Start of recruitment: 01/10/2020 End of recruitment (estimated): December 2020. TRIAL REGISTRATION: EudraCT Number: 2020-002193-27 , registered on July 14th, 2020. NCT number: NCT04615429 , registered on November 4th, 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.

Se hace camino al andar: Educación médica de pregrado en el Departamento de Cirugía, Universidad de La Sabana / The path is made by walking: Undergraduate medical education in the Department of Surgery, Universidad de La Sabana

La educación médica en cirugía en Colombia esta experimentando una acelerada transformación, no obstante, la documentación de esta transformación educativa en el país es limitada. En este estudio se presenta una revisión cronológica de la enseñanza en el Departamento de Cirugía de la institución. La revisión se focaliza en las estrategias e hitos alcanzados en el pregrado, luego de transformar el modelo de enseñanza tradicional de principios de siglo XXI. La revisión está basada en la síntesis de una serie de estudios originales, los cuales ofrecen evidencia sobre las intervenciones realizadas en el departamento, y sobre sus resultados. Finalmente, se presenta una reflexión en torno a los retos futuros

Surgical education in Colombia is undergoing an accelerated transformation, however, the documentation of this educational transformation in the country is limited. This study presents a chronological review of teaching in the Department of Surgery of the institution. The review focuses on the strategies and milestones achieved in undergraduate level, after transforming the traditional teaching model of the early 21st century. The review is based on the synthesis of a series of original studies, which offer evidence on the interventions conducted in the department, and on their results. Finally, a reflection on future challenges is presented

Organ Donation and Transplantation During the COVID-19 Pandemic: A Summary of the Spanish Experience.

BACKGROUND: Spain has been amongst the countries most affected by the COVID-19 pandemic, which has posed significant challenges to the donation and transplantation program. Despite a dramatic decrease of donation and transplantation activities during the critical early weeks of the outbreak, the program has recovered and is learning to cope with COVID-19. METHODS: We describe the 4 pillars upon which the Spanish donation and transplantation program has been rebuilt. RESULTS: (1) Standards have been developed and progressively updated for the evaluation and selection of potential donors and recipients with regards to SARS-CoV-2 infection. (2) Spain has been actively generating evidence to assess the validity of our standards and to understand the natural history of the infection in transplant recipients. No case of donor-derived COVID-19 has been reported to date. COVID-19 has been more frequent and has had a more aggressive course in recipients of solid organ transplants than in the general population, but this seems largely explained by the demographics and comorbidity of transplant patients. (3) As a result of this evidence and experience, recommendations have been issued for the management of COVID-19 in solid organ transplant recipients and candidates on the waiting list. (4) Finally, concrete guidance has been issued for centers to manage the donation and transplantation programs in relation to a dynamic and heterogeneous epidemiologic scenario. CONCLUSIONS: The Spanish experience confronting the impact of COVID-19 upon donation and transplantation may help serve the needs of a broader community in other countries.

Validation of a new proposal to avoid donor resuscitation in controlled donation after circulatory death with normothermic regional perfusion.

AIM: The use of abdominal normothermic regional perfusion (nRP) and premortem interventions in controlled donation after circulatory death (cDCD) may represent a significant advance to increase the number and quality of grafts recovered in cDCD. The main limitation for the widespread acceptance of nRP in cDCD is the concerns of restoring circulation to the brain once death has been declared should the thoracic aorta not be adequately blocked. METHODS: We describe and validate a specific methodology to ensure an appropriate blocking of the thoracic aorta in a multicenter study using this technique. RESULTS: A total of 78 procedures with premortem cannulation and abdominal nRP were performed in four different hospitals. No case of heart or brain resuscitation was observed after nRP CONCLUSION: The use of premortem interventions before nRP and the aortic occlusion balloon may increase the number of grafts recovered in cDCD. Our proposed methodology avoids the ethical problem of resuscitation by guaranteeing that circulation to the heart and brain is not restored after nRP.

Trasplante de pulmón con donantes no controlados a corazón parado. Factores pronósticos dependientes del donante y evolución inmediata postrasplante / Lung Transplantation with Uncontrolled Non-Heart-Beating Donors. Transplantation. Donor Prognostic Factor and Immediate Evolution Post Transplant

Introducción: La donación en asistolia no controlada (DANC) constituye una alternativa al trasplantepulmonar con donantes en muerte encefálica. El objetivo principal del estudio es describir la incidenciade eventos al mes tras el trasplante con pulmones de DANC, y la influencia de los factores dependientesdel donante y del proceso de donación.Pacientes y métodos: Estudio de una cohorte histórica de 33 receptores de trasplante pulmonar realizadosen los hospitales Puerta de Hierro y Marqués de Valdecilla con 32 DANC procedentes del Hospital ClínicoSan Carlos durante el periodo 2002-2008. Se estudiaron los siguientes eventos: complicaciones quirúrgicasy médicas, disfunción primaria del injerto, rechazo agudo, neumonía y mortalidad. Se evaluaron lascaracterísticas del donante y los tiempos del proceso de donación (minutos).Resultados: La mediana de edad de los receptores fue 50,5 años (rango intercuartílico, 38,5-58); 28 hombresy 5 mujeres. La incidencia acumulada de los eventos al mes fue: neumonía, 10 (31,3%); disfunciónprimaria del injerto, 15 (46,9%); rechazo, 12 (37,5%); mortalidad, 4 (12,1%); complicaciones médicas,25 (78,1%), y quirúrgicas, 18 (56,3%). La mediana del tiempo de asistolia fue mayor en los sujetos conneumonía (15 vs. 7,5; p = 0,027), la mediana del tiempo de isquemia fría fue superior en los sujetos quepresentaron complicaciones quirúrgicas y mortalidad (436 vs. 343,5; p = 0,04; 505 vs. 410; p = 0,033, respectivamente),y las medianas de los tiempos de isquemia total fueron superiores en los receptores quefallecieron (828 vs. 695; p = 0,036).Conclusiones: Los DANC constituyen una alternativa válida para expandir el pool de donantes pulmonaresante la carencia actual de pulmones válidos para el trasplante. La incidencia de complicaciones escomparable con los datos publicados en la literatura(AU)

Introduction: Uncontrolled donation after cardiac death (DACD) has become an alternative to lung transplantationwith encephalic-death donation. The main objective of this study is to describe the incidenceof clinically relevant events in the period of thirty days after lung transplant with uncontrolled DACD andthe influence of factors depending on the donor and donation process as well.Patients and methods: Historical cohort study of 33 lung transplant receivers at Hospital Puerta de Hierro and Hospital Marqués de Valdecilla with 32 DACD from Hospital Clínico San Carlos from 2002 to 2008.We studied surgical and medical complications, primary graft dysfunction, acute rejection, pneumonia and mortality. We made an evaluation of the donor characteristics and donation procedure times (minutes). Results: Median age of recipients was 50.5 years (interquartile range, 38.5-58). There were 28 malesand 5 females. Cumulative incidence of events in the first month was: pneumonia 10 (31.3%); primarygraft dysfunction 15 (46.9%); rejection 12 (37.5%); mortality 4 (12.1%); medical complications 25 (78.1%);and surgical complications 18(56.3%). Median time of cardiac arrest was higher in those who presentedpneumonia (15 vs. 7.5; p = 0.027). Median time of cold ischemia was higher in those who presentedsurgical complications and mortality (436 vs. 343.5; p = 0.04; 505 vs. 410; p = 0.033, respectively), andmedian of total ischemia times were longer in the recipients who died (828 vs. 695; p = 0.036).Conclusions: Uncontrolled DACD are a valid alternative for expanding the donor pool in order to mitigatethe current shortage of lungs that are valid for transplantation. The incidence of complications iscomparable with published data in the literature(AU)

[Lung transplantation with uncontrolled non-heart-beating donors. Transplantation. Donor prognostic factor and immediate evolution post transplant]. / Trasplante de pulmón con donantes no controlados a corazón parado. Factores pronósticos dependientes del donante y evolución inmediata postrasplante.

INTRODUCTION: Uncontrolled donation after cardiac death (DACD) has become an alternative to lung transplantation with encephalic-death donation. The main objective of this study is to describe the incidence of clinically relevant events in the period of thirty days after lung transplant with uncontrolled DACD and the influence of factors depending on the donor and donation process as well. PATIENTS AND METHODS: Historical cohort study of 33 lung transplant receivers at Hospital Puerta de Hierro and Hospital Marqués de Valdecilla with 32 DACD from Hospital Clínico San Carlos from 2002 to 2008. We studied surgical and medical complications, primary graft dysfunction, acute rejection, pneumonia and mortality. We made an evaluation of the donor characteristics and donation procedure times (minutes). RESULTS: Median age of recipients was 50.5 years (interquartile range, 38.5-58). There were 28 males and 5 females. Cumulative incidence of events in the first month was: pneumonia 10 (31.3%); primary graft dysfunction 15 (46.9%); rejection 12 (37.5%); mortality 4 (12.1%); medical complications 25 (78.1%); and surgical complications 18 (56.3%). Median time of cardiac arrest was higher in those who presented pneumonia (15 vs. 7.5; p = 0.027). Median time of cold ischemia was higher in those who presented surgical complications and mortality (436 vs. 343.5; p = 0.04; 505 vs. 410; p = 0.033, respectively), and median of total ischemia times were longer in the recipients who died (828 vs. 695; p = 0.036). CONCLUSIONS: Uncontrolled DACD are a valid alternative for expanding the donor pool in order to mitigate the current shortage of lungs that are valid for transplantation. The incidence of complications is comparable with published data in the literature.