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

Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis

Background: Mesenchymal stromal cells are a safe and promising option to treat knee osteoarthritis as previously demonstrated in different clinical trials. However, their efficacy, optimal dose and addition of adjuvants must be determined. Here, we evaluated the clinical effects of a dose of 100 × 106 bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®) as adjuvant in a randomized clinical trial. Methods: A phase II, multicenter, randomized clinical trial with active control was conducted. Sixty patients diagnosed with knee OA were randomly assigned to 3 weekly doses of PRGF® or intraarticular administration of 100 × 106 cultured autologous BM-MSCs plus PRGF®. Patients were followed up for 12 months, and pain and function were assessed using VAS and WOMAC and by measuring the knee range of motion range. X-ray and magnetic resonance imaging analyses were performed to analyze joint damage. Results: No adverse effects were reported after BM-MSC administration or during follow-up. According to VAS, the mean value (SD) for PRGF® and BM-MSC with PRGF® went from 5 (1.8) to 4.5 (2.2) (p = 0.389) and from 5.3 (1.9) to 3.5 (2.5) (p = 0.01), respectively at 12 months. In WOMAC, the mean (SD) baseline and 12-month overall WOMAC scores in patients treated with PRGF® was 31.9 (16.2) and 22.3 (15.8) respectively (p = 0.002) while that for patients treated with BM-MSC plus PRGF® was 33.4 (18.7) and 23.0 (16.6) (p = 0.053). Although statistical significances between groups have been not detected, only patients being treated with BM-MSC plus PRGF® could be considered as a OA treatment responders following OARSI criteria. X-ray and MRI (WORMS protocol) revealed no changes in knee joint space width or joint damage. Conclusions: Treatment with BM-MSC associated with PRGF® was shown to be a viable therapeutic option for osteoarthritis of the knee, with clinical improvement at the end of follow-up. Further phase III clinical trials would be necessary to confirm the efficacy. Trial registration Clinical Trials.gov identifier NCT02365142. Nº EudraCT: 2011-006036-23

Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis

Background: Mesenchymal stromal cells are a safe and promising option to treat knee osteoarthritis as previously demonstrated in different clinical trials. However, their efficacy, optimal dose and addition of adjuvants must be determined. Here, we evaluated the clinical effects of a dose of 100 × 106 bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®) as adjuvant in a randomized clinical trial. Methods: A phase II, multicenter, randomized clinical trial with active control was conducted. Sixty patients diagnosed with knee OA were randomly assigned to 3 weekly doses of PRGF® or intraarticular administration of 100 × 106 cultured autologous BM-MSCs plus PRGF®. Patients were followed up for 12 months, and pain and function were assessed using VAS and WOMAC and by measuring the knee range of motion range. X-ray and magnetic resonance imaging analyses were performed to analyze joint damage. Results: No adverse effects were reported after BM-MSC administration or during follow-up. According to VAS, the mean value (SD) for PRGF® and BM-MSC with PRGF® went from 5 (1.8) to 4.5 (2.2) (p = 0.389) and from 5.3 (1.9) to 3.5 (2.5) (p = 0.01), respectively at 12 months. In WOMAC, the mean (SD) baseline and 12-month overall WOMAC scores in patients treated with PRGF® was 31.9 (16.2) and 22.3 (15.8) respectively (p = 0.002) while that for patients treated with BM-MSC plus PRGF® was 33.4 (18.7) and 23.0 (16.6) (p = 0.053). Although statistical significances between groups have been not detected, only patients being treated with BM-MSC plus PRGF® could be considered as a OA treatment responders following OARSI criteria. X-ray and MRI (WORMS protocol) revealed no changes in knee joint space width or joint damage. Conclusions: Treatment with BM-MSC associated with PRGF® was shown to be a viable therapeutic option for osteoarthritis of the knee, with clinical improvement at the end of follow-up. Further phase III clinical trials would be necessary to confirm the efficacy. Trial registration Clinical Trials.gov identifier NCT02365142. Nº EudraCT: 2011-006036-23

Network Analysis of Posttraumatic Growth Dimensions: A Cross-Sectional Study in People Who Experienced the Death of a Loved One from COVID-19 in 16 Latin American Countries

The present study aimed to apply a network analysis model to provide an exploratory empirical conceptualization of dynamic networks of posttraumatic growth (PTG) symptoms in 7,434 people who experienced the death of a loved one from COVID-19 in 16 Latin American countries. The Post-Traumatic Growth Inventory: Short Form of Eight Items was used. A non-regularized network with partial correlation coefficients was estimated through the ggmModSelect algorithm. The network architecture was analyzed for each country through its local properties and global properties. The results indicated that the networks differed significantly between countries. The core dimensions in the networks were relating to others, personal strength, and life value and opportunities, which were more related dimensions that reinforce the emergence of PTG in all countries. The findings may be useful to motivate researchers and mental health professionals to consider the importance of the individual dimensions of PTG in groups of people who experienced the death of a loved one from COVID-19 in 16 Latin American countries, as well as their interrelationships.Fil: Caycho Rodríguez, Tomás. Universidad Científica del Sur; PerúFil: Baños Chaparro, Jonatan. Universidad Científica del Sur; PerúFil: Ventura León, José. Universidad Privada del Norte; PerúFil: Vilca, Lindsey W.. Universidad Norbert Wiener; PerúFil: Carbajal León, Carlos. Universidad Norbert Wiener; PerúFil: Valencia, Pablo D.. Universidad Nacional Autónoma de México; MéxicoFil: Yupanqui Lorenzo, Daniel E.. Universidad de Ciencias y Humanidades; PerúFil: Paredes Angeles, Rubí. Universidad Peruana Cayetano Heredia;Fil: Arias Gallegos, Walter L.. Universidad Católica San Pablo; PerúFil: Reyes Bossio, Mario. Universidad Peruana de Ciencias Aplicadas; PerúFil: Delgado Campusano, Mariel. Universidad Peruana de Ciencias Aplicadas; PerúFil: Gallegos de San Vicente, Miguel Omar. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Pontifícia Universidade Católica de Minas Gerais; BrasilFil: Rojas Jara, Claudio. Universidad Católica de Maule; ChileFil: Polanco Carrasco, Roberto. Centro de Estudios Académicos En Neuropsicología; ChileFil: Cervigni, Mauricio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Rosario. Facultad de Psicología. Secretaria de Ciencia y Tecnología. Centro de Investigación En Neurociencias de Rosario; ArgentinaFil: Martino, Pablo Luis. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de San Luis. Facultad de Psicología. Departamento Formación Basica. Laboratorio de Ciencias de Comportamiento; Argentina. Universidad Nacional de Rosario. Facultad de Psicología; ArgentinaFil: Lobos Rivera, Marlon Elías. Universidad Tecnológica de El Salvador; El SalvadorFil: Moreta Herrera, Rodrigo. Pontificia Universidad Católica del Ecuador; EcuadorFil: Palacios Segura, Diego Alejandro. Universidad Mariano Gálvez; GuatemalaFil: Samaniego Pinho, Antonio. Universidad Nacional de Asunción; ParaguayFil: Buschiazzo Figares, Andrés. Centro de Estudios Adlerianos; UruguayFil: Puerta Cortés, Diana Ximena. Universidad de Ibagué; ColombiaFil: Camargo, Andrés. Fundación Universitaria del Área Andina; ColombiaFil: Torales, Julio. Universidad Nacional de Asunción; ParaguayFil: Vega, Diego. Universidad Latina de Costa Rica; Costa RicaFil: Schulmeyer, Marion K.. Universidad Privada de Santa Cruz de la Sierra; BoliviaFil: Barria Asenjo, Nicol A.. Universidad de Los Lagos; ChileFil: Urrutia Rios, Hassell Tatiana. Asociación Nicaragüense para el desarrollo de la Psicología; NicaraguaFil: Lira Lira, Arelly Esther. Asociación Nicaragüense para el desarrollo de la Psicología; NicaraguaFil: Ayala Colqui, Jesús. Universidad Tecnológica del Perú; Per

Cross-cultural invariance of the Spanish version of the COVID-19 Assessment Scorecard to measure the perception of government actions against COVID-19 in Latin America

Objectives: The present study aimed to evaluate the measurement invariance of a general measure of the perception of governmental responses to COVID-|19 (COVID-SCORE-10) in the general population of 13 Latin American countries. Methods: A total of 5780 individuals from 13 Latin American and Caribbean countries selected by non-probabilistic snowball sampling participated. A confirmatory factor analysis was performed and the alignment method was used to evaluate invariance. Additionally, a graded response model was used for the assessment of item characteristics. Results: The results indicate that there is approximate measurement invariance of the COVID-SCORE-10 among the participating countries. Furthermore, IRT results suggest that the COVID-SCORE-10 measures with good psychometric ability a broad spectrum of the construct assessed, especially around average levels. Comparison of COVID-SCORE-10 scores indicated that participants from Cuba, Uruguay and El Salvador had the most positive perceptions of government actions to address the pandemic. Thus, the underlying construct of perception of government actions was equivalent in all countries. Conclusion: The results show the importance of initially establishing the fundamental measurement properties and MI before inferring the cross-cultural universality of the construct to be measured.Fil: Caycho Rodríguez, Tomás. Universidad Cientifica del Sur;Fil: Valencia, Pablo D.. Universidad Nacional Autónoma de México; MéxicoFil: Ventura León, José. Universidad Privada del Norte; PerúFil: Carbajal León, Carlos. Universidad Norbert Wiener; PerúFil: Vilca, Lindsey W.. Universidad Norbert Wiener; PerúFil: Reyes Bossio, Mario. Universidad Peruana de Ciencias Aplicadas; PerúFil: Delgado Campusano, Mariel. Universidad Peruana de Ciencias Aplicadas; PerúFil: Yupanqui Lorenzo, Daniel E.. Universidad de Ciencias y Humanidades; PerúFil: Paredes Angeles, Rubí. Universidad Peruana Cayetano Heredia;Fil: Rojas Jara, Claudio. Universidad Católica de Maule; ChileFil: Gallegos de San Vicente, Miguel Omar. Universidad Católica de Maule; Chile. Universidad Nacional de Rosario; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Pontifícia Universidade Católica de Minas Gerais; BrasilFil: Cervigni, Mauricio Alejandro. Universidad Nacional de Rosario; Argentina. Universidad Adventista del Plata; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Martino, Pablo Luis. Universidad Nacional de San Luis. Facultad de Psicología. Departamento Formación Basica. Laboratorio de Ciencias de Comportamiento; Argentina. Universidad Nacional de Rosario. Facultad de Psicología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Polanco Carrasco, Roberto. Cuadernos de Neuropsicología; ChileFil: Palacios, Diego Alejandro. Universidad Mariano Gálvez; GuatemalaFil: Moreta-Herrera, Rodrigo. Pontificia Universidad Católica del Ecuador; EcuadorFil: Samaniego Pinho, Antonio. Universidad Nacional de Asunción; ParaguayFil: Lobos Rivera, Marlon Elías. Universidad Tecnológica de El Salvador; El SalvadorFil: Buschiazzo Figares, Andrés. Instituto Alfred Adler Uruguay; UruguayFil: Puerta Cortés, Diana Ximena. Universidad de Ibagué; ColombiaFil: Corrales Reyes, Ibraín Enrique. Hospital General Universitario Carlos Manuel de Céspedes; CubaFil: Calderón, Raymundo. Colegio Estatal de Psicólogos En Intervención de Jalisco A.c. Guadalajara; MéxicoFil: Arias Gallegos, Walter L.. Universidad Católica San Pablo; PerúFil: Petzold, Olimpia. Lone Star College; Estados UnidosFil: Vergara, Ibeth. Universidad Latina de Panamá; PanamáFil: Vega, Diego. Universidad Latina de Costa Rica; Costa RicaFil: Barria Asenjo, Nicol A.. Universidad de Los Lagos; ChileFil: Schulmeyer, Marion K.. Universidad Privada de Santa Cruz de la Sierra; BoliviaFil: Urrutia Rios, Hassell Tatiana. Asociación Nicaragüense para el desarrollo de la psicología; NicaraguaFil: Lira Lira, Arelly Esther. Asociación Nicaragüense para el desarrollo de la psicología; Nicaragu

Relationship Between Fear of COVID-19, Conspiracy Beliefs About Vaccines and Intention to Vaccinate Against COVID-19: A Cross-National Indirect Effect Model in 13 Latin American Countries

The present study explored the predictive capacity of fear of COVID-19 on the intention to be vaccinated against COVID-19 and the influence in this relationship of conspiracy beliefs as a possible mediating psychological variable, in 13 Latin American countries. A total of 5779 people recruited through non-probabilistic convenience sampling participated. To collect information, we used the Fear of COVID-19 Scale, Vaccine conspiracy beliefs Scale-COVID-19 and a single item of intention to vaccinate. A full a priori Structural Equation Model was used; whereas, cross-country invariance was performed from increasingly restricted structural models. The results indicated that, fear of COVID-19 positively predicts intention to vaccinate and the presence of conspiracy beliefs about COVID-19 vaccines. The latter negatively predicted intention to vaccinate against COVID-19. Besides, conspiracy beliefs about COVID-19 vaccines had an indirect effect on the relationship between fear of COVID-19 and intention to vaccinate against COVID-19 in the 13 countries assessed. Finally, the cross-national similarities of the mediational model among the 13 participating countries are strongly supported. The study is the first to test a cross-national mediational model across variables in a large number of Latin American countries. However, further studies with other countries in other regions of the world are needed.Fil: Caycho Rodríguez, Tomás. Universidad Cientifica del Sur;Fil: Tomás, José M.. Universidad de Valencia; EspañaFil: Yupanqui Lorenzo, Daniel E.. Universidad de Ciencias y Humanidades; PerúFil: Valencia, Pablo D.. Universidad Nacional Autónoma de México; MéxicoFil: Carbajal León, Carlos. Universidad Norbert Wiener; PerúFil: Vilca, Lindsey W.. Universidad Norbert Wiener; PerúFil: Ventura León, José. Universidad Privada del Norte; PerúFil: Paredes Angeles, Rubí. Universidad Peruana Cayetano Heredia;Fil: Arias Gallegos, Walter L.. Universidad Católica San Pablo; PerúFil: Reyes Bossio, Mario. Universidad Peruana de Ciencias Aplicadas; PerúFil: Delgado Campusano, Mariel. Universidad Peruana de Ciencias Aplicadas; PerúFil: Gallegos de San Vicente, Miguel Omar. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Pontifícia Universidade Católica de Minas Gerais; BrasilFil: Rojas Jara, Claudio. Universidad Católica de Maule; ChileFil: Polanco Carrasco, Roberto. Centro de Estudios Académicos En Neuropsicología; ChileFil: Cervigni, Mauricio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Rosario; ArgentinaFil: Martino, Pablo Luis. Universidad Nacional de San Luis. Facultad de Psicología. Departamento Formación Basica. Laboratorio de Ciencias de Comportamiento; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Rosario. Facultad de Psicología; ArgentinaFil: Lobos Rivera, Marlon Elías. Universidad Tecnológica de El Salvador; El SalvadorFil: Moreta Herrera, Rodrigo. Pontificia Universidad Católica del Ecuador; EcuadorFil: Palacios Segura, Diego Alejandro. Universidad Mariano Gálvez; GuatemalaFil: Samaniego Pinho, Antonio. Universidad Nacional de Asunción; ParaguayFil: Buschiazzo Figares, Andrés. Centro de Estudios Adlerianos; UruguayFil: Puerta Cortés, Diana Ximena. Universidad de Ibagué; ColombiaFil: Camargo, Andrés. Fundación Universitaria del Área Andina; ColombiaFil: Torales, Julio. Universidad Nacional de Asunción; ParaguayFil: Vergara, Ibeth. Universidad Latina de Panamá; Panamá. Asociación Panameña de Psicólogos; PanamáFil: Vega, Diego. Universidad Latina de Costa Rica; Costa RicaFil: Shulmeyer, Marion K.. Universidad Privada de Santa Cruz de la Sierra; BoliviaFil: Barria Asenjo, Nicol A.. Universidad de Los Lagos; ChileFil: Urrutia Rios, Hassell Tatiana. Asociación Nicaragüense para el Desarrollo de la Psicología; ArgentinaFil: Lira Lira, Arelly Esther. Asociación Nicaragüense para el Desarrollo de la Psicología; Argentin

Safety of hospital discharge before return of bowel function after elective colorectal surgery

Background: Ileus is common after colorectal surgery and is associated with an increased risk of postoperative complications. Identifying features of normal bowel recovery and the appropriateness for hospital discharge is challenging. This study explored the safety of hospital discharge before the return of bowel function.Methods: A prospective, multicentre cohort study was undertaken across an international collaborative network. Adult patients undergoing elective colorectal resection between January and April 2018 were included. The main outcome of interest was readmission to hospital within 30 days of surgery. The impact of discharge timing according to the return of bowel function was explored using multivariable regression analysis. Other outcomes were postoperative complications within 30 days of surgery, measured using the Clavien-Dindo classification system.Results: A total of 3288 patients were included in the analysis, of whom 301 (9.2 per cent) were discharged before the return of bowel function. The median duration of hospital stay for patients discharged before and after return of bowel function was 5 (i.q.r. 4-7) and 7 (6-8) days respectively (P &lt; 0.001). There were no significant differences in rates of readmission between these groups (6.6 versus 8.0 per cent; P = 0.499), and this remained the case after multivariable adjustment for baseline differences (odds ratio 0.90, 95 per cent c.i. 0.55 to 1.46; P = 0.659). Rates of postoperative complications were also similar in those discharged before versus after return of bowel function (minor: 34.7 versus 39.5 per cent; major 3.3 versus 3.4 per cent; P = 0.110).Conclusion: Discharge before return of bowel function after elective colorectal surgery appears to be safe in appropriately selected patients

Safety of hospital discharge before return of bowel function after elective colorectal surgery

Background Ileus is common after colorectal surgery and is associated with an increased risk of postoperative complications. Identifying features of normal bowel recovery and the appropriateness for hospital discharge is challenging. This study explored the safety of hospital discharge before the return of bowel function. Methods A prospective, multicentre cohort study was undertaken across an international collaborative network. Adult patients undergoing elective colorectal resection between January and April 2018 were included. The main outcome of interest was readmission to hospital within 30 days of surgery. The impact of discharge timing according to the return of bowel function was explored using multivariable regression analysis. Other outcomes were postoperative complications within 30 days of surgery, measured using the Clavien-Dindo classification system. Results A total of 3288 patients were included in the analysis, of whom 301 (9 center dot 2 per cent) were discharged before the return of bowel function. The median duration of hospital stay for patients discharged before and after return of bowel function was 5 (i.q.r. 4-7) and 7 (6-8) days respectively (P &lt; 0 center dot 001). There were no significant differences in rates of readmission between these groups (6 center dot 6 versus 8 center dot 0 per cent; P = 0 center dot 499), and this remained the case after multivariable adjustment for baseline differences (odds ratio 0 center dot 90, 95 per cent c.i. 0 center dot 55 to 1 center dot 46; P = 0 center dot 659). Rates of postoperative complications were also similar in those discharged before versus after return of bowel function (minor: 34 center dot 7 versus 39 center dot 5 per cent; major 3 center dot 3 versus 3 center dot 4 per cent; P = 0 center dot 110). Conclusion Discharge before return of bowel function after elective colorectal surgery appears to be safe in appropriately selected patients