Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

Diálogos y debates de la investigación jurídica y sociojurídica en Nariño

This book is divided into two thematic parts. The first addresses the most recent discussions regarding contemporary debates of law. Topics related to labor law —labor and sex workers rights— are discussed; private law —religious indoctrination—, the theory and philosophy of law —democracy, rule of law and responsibilities of the legislator—; and the relationship of law with education around peace and respect for diversity. The second part is devoted to Law and social struggles: private security policies and the monopoly of legitimate violence in the areas affected by the armed conflict; agrarian reform from a historical and economic perspective; the rights of nature; the role of ethnoeducation in the dynamics of empowerment of the indigenous and Afro-Colombian population; and the importance of sustainable development in the promotion and use of non-conventional renewable energy. The topics covered in are approached from economic, sociological, philosophical, and legal perspectives, which allows the debate about the realities of Nariñenses to be easily understood and analyzed for the different readers.Este libro está dividido en dos partes temáticas. La primera aborda las discusiones más recientes en torno a los debates contemporáneos del derecho. Se tocan temas relacionados con el derecho laboral —derechos laborales y de trabajadoras sexuales—; el derecho privado —adoctrinamiento religioso—, la teoría y filosofía del derecho —democracia, Estado de derecho y responsabilidades del legislador—; y la relación del derecho con la educación en torno a la paz y el respeto a la diversidad. La segunda parte está dedicada al derecho y las luchas sociales: las políticas de seguridad privada y el monopolio de la violencia legítima en las zonas afectadas por el conflicto armando; la reforma agraria desde una perspectiva histórica y económica; los derechos de la naturaleza; el papel de la etnoeducación en las dinámicas de empoderamiento de la población indígena y afrocolombiana; y la importancia del desarrollo sostenible en el fomento y uso de las energías renovables no convencionales. Los temas tratados en se abordan desde perspectivas económicas, sociológicas, filosóficas y jurídicas, lo que permite que el debate en torno a las realidades nariñenses resulte de fácil comprensión y análisis para los diferentes lectores.Palabras clave: comunidades afrocolombianas, comunidades indígenas, derecho al medio ambiente, derecho laboral, derechos de la naturaleza, etnoeducación, Nariño

Diálogos y debates de la investigación jurídica y sociojurídica en Nariño

This book is divided into two thematic parts. The first addresses the most recent discussions regarding contemporary debates of law. Topics related to labor law —labor and sex workers rights— are discussed; private law —religious indoctrination—, the theory and philosophy of law —democracy, rule of law and responsibilities of the legislator—; and the relationship of law with education around peace and respect for diversity. The second part is devoted to Law and social struggles: private security policies and the monopoly of legitimate violence in the areas affected by the armed conflict; agrarian reform from a historical and economic perspective; the rights of nature; the role of ethnoeducation in the dynamics of empowerment of the indigenous and Afro-Colombian population; and the importance of sustainable development in the promotion and use of non-conventional renewable energy. The topics covered in are approached from economic, sociological, philosophical, and legal perspectives, which allows the debate about the realities of Nariñenses to be easily understood and analyzed for the different readers.Este libro está dividido en dos partes temáticas. La primera aborda las discusiones más recientes en torno a los debates contemporáneos del derecho. Se tocan temas relacionados con el derecho laboral —derechos laborales y de trabajadoras sexuales—; el derecho privado —adoctrinamiento religioso—, la teoría y filosofía del derecho —democracia, Estado de derecho y responsabilidades del legislador—; y la relación del derecho con la educación en torno a la paz y el respeto a la diversidad. La segunda parte está dedicada al derecho y las luchas sociales: las políticas de seguridad privada y el monopolio de la violencia legítima en las zonas afectadas por el conflicto armando; la reforma agraria desde una perspectiva histórica y económica; los derechos de la naturaleza; el papel de la etnoeducación en las dinámicas de empoderamiento de la población indígena y afrocolombiana; y la importancia del desarrollo sostenible en el fomento y uso de las energías renovables no convencionales. Los temas tratados en se abordan desde perspectivas económicas, sociológicas, filosóficas y jurídicas, lo que permite que el debate en torno a las realidades nariñenses resulte de fácil comprensión y análisis para los diferentes lectores.Palabras clave: comunidades afrocolombianas, comunidades indígenas, derecho al medio ambiente, derecho laboral, derechos de la naturaleza, etnoeducación, Nariño

Carotenoides en agroalimentación y salud

Los carotenoides son compuestos especiales; si bien es común referirse a ellos como pigmentos, lo cierto es que son compuestos de gran versatilidad e importancia en la naturaleza. Más específicamente, son de gran interés en agroalimentación y salud. Así, por ejemplo, son pigmentos naturales y por lo tanto tienen un importante papel en la elección de alimentos por parte de los consumidores. Asimismo, algunos de ellos son precursores de la vitamina A. Sin embargo, que cada vez exista más interés en los carotenoides en este contexto se debe en gran parte a muchos estudios de distinta naturaleza que indican que pueden proporcionar beneficios para la salud. Su interés en alimentación funcional es por lo tanto indudable. En este libro se refleja la experiencia en carotenoides de un gran número de profesionales de la región iberoamericana. En conjunto, se ofrece una visión general de la investigación sobre estos compuestos en agroalimentación y salud. Los autores son miembros de la red ibercarot (http://carotenoides.us.es), que tiene entre sus objetivos conformar una red estable y funcional de profesionales que aúnen esfuerzos en pos de identificar nuevas fuentes de carotenoides de interés nutricional, mejorar su producción y aumentar el valor de los productos que los contengan. Me gustaría agradecer a todas y cada una de las personas que han contribuido de una u otra forma a que este libro sea una realidad. Todos esperamos que sea de ayuda para personas interesadas en los temas desarrollados. Gracias especialmente al Programa Iberoamericano de Ciencia y Tecnología para el Desarrollo (Cyted, http:// www.cyted.org/) que, con su apoyo económico a la red ibercarot, ha hecho posible que varias decenas de equipos interaccionen en torno a temas de interés común para contribuir al desarrollo a distintos niveles de la región iberoamericana.RED TEMÁTICA IBERCAROT (referencia 112RT445) http://carotenoides.us.es PROGRAMA IBEROAMERICANO DE CIENCIA Y TECNOLOGIA PARA EL DESARROLLO – CYTEDPeer reviewe

Revista Temas Agrarios Volumen 26; Suplemento 1 de 2021

1st International and 2nd National Symposium of Agronomic Sciences: The rebirth of the scientific discussion space for the Colombian Agro.1 Simposio Intenacional y 2 Nacional de Ciencias Agronómicas: El renacer del espacio de discusión científica para el Agro colombiano

Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trialResearch in context

Summary: Background: Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. Methods: We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. ClinicalTrials.gov registry: NCT04847141. Findings: 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; −9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Interpretation: Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. Funding: Grifols

Critical care admission following elective surgery was not associated with survival benefit: prospective analysis of data from 27 countries

This was an investigator initiated study funded by Nestle Health Sciences through an unrestricted research grant, and by a National Institute for Health Research (UK) Professorship held by RP. The study was sponsored by Queen Mary University of London

Prospective observational cohort study on grading the severity of postoperative complications in global surgery research

Background The Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high- (HICs) and low- and middle-income countries (LMICs). Methods This was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7-day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparing HICs with LMICs. Results A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien–Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59). Conclusion Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally