Core data set para la generación de datos de la vida real en esclerosis múltiple: adaptación de una iniciativa global para América Latina / Core data set for real world data in multiple sclerosis: customization for latin america from a global task force recommendation

Introducción: Los objetivos primarios del core data set son reducir la heterogeneidad y promover la armonización entre las fuentes de datos en la esclerosis múltiple (EM), reduciendo así el tiempo necesario para ejecutar esfuerzos en la recolección de datos de vida real. Recientemente, un grupo liderado por la Multiple Sclerosis Data Alliance ha desarrollado un core data set para la recolección de datos del mundo real en EM a nivel global. Nuestro objetivo ha sido adaptar y consensuar este conjunto de datos globales a las necesidades de América Latina para que pueda ser implementado por los registros ya desarrollados y en proceso de desarrollo en la región. Material y métodos. Se conformó un grupo de trabajo regionalmente y se adaptó el core data set creado globalmente (proceso de traducción al español, incorporación de variables regionales y consenso sobre variables que se iban a utilizar). El consenso se obtuvo a través de la metodología Delphi remoto de ronda de cuestionarios y discusión a distancia de las variables del core data set. Resultados: Veinticinco profesionales de América Latina llevaron adelante el proceso de adaptación entre noviembre de 2022 y julio de 2023. Se estableció un acuerdo sobre un core data set de nueve categorías y 45 variables, versión 2023, con la sugerencia de implementarlo en registros desarrollados o en vías de desarrollo y cohortes de EM en la región. Conclusión: El core data set busca armonizar las variables recolectadas por los registros y las cohortes de EM en América Latina con el fin de facilitar dicha recolección y permitir una colaboración entre fuentes. Su implementación facilitará la recolección de datos de vida real y la colaboración en la región.(AU)

Introduction: The primary objective of the core data set is to reduce heterogeneity and promote harmonization among data sources in EM, thereby reducing the time needed to execute real life data collection efforts. Recently, a group led by the Multiple Sclerosis Data Alliance has developed a core data set for collecting real-world data on multiple sclerosis (MS) globally. Our objective was to adapt this global data set to the needs of Latin America, so that it can be implemented by the registries already developed and in the process of development in the region. Material and methods: A working group was formed regionally, the core data set created globally was adapted (translation process into Spanish, incorporation of regional variables and consensus on variables to be used). Consensus was obtained through the remote Delphi methodology of a round of questionnaires and remote discussion of the core data set variables. Results: A total of 25 professionals from Latin America carried out the adaptation process between November 2022 and July 2023. Agreement was established on a core data set of nine categories and 45 variables, version 2023 to suggest its implementation in developed or developing registries, and MS cohorts in the region. Conclusion: The core data set seeks to harmonize the variables collected by registries and cohorts in MS in Latin America in order to facilitate said collection and allow collaboration between sources. Its implementation will facilitate real life data collection and collaboration in the region.(AU)

2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation.

In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .

Test-retest reliability of Latin American Group for Maturity (GDLAM) protocol in older women.

Functional autonomy (FA) is a critical factor in determining the quality of life of older adults (OA), especially in the case of older women (OW), as they face a decline in FA in their later years of life. FA should be assessed early, using valid, reliable, and low-cost tests. This study evaluated the test-retest reliability of GDLAM and GDLAM autonomy index (GI) in OW. Thirty-nine OW (71.2 ± 6.50 years) participated in the study. A repeated measures design was used to compare the interday test-retest reliability of the five GDLAM tests (seconds) and the GI (points). The five tests represent activities of daily living, such as dressing or wandering around the house, while the GI provides a weighting of the results of the five tests. The analysis consisted of the intraclass correlation coefficient (ICC), standard error of measurement (SEM), and coefficient of variation (CV). A CV ≤ 10% and an ICC ≥ 0.80 were considered acceptable reliability, whereas a CV ≤ 5% and an ICC ≥ 0.90 were considered high reliability. The outcome of the five tests, represented by the GI, showed high interday test-retest reliability (CV = 6.00% and ICC = 0.91). The results of this study demonstrate that the five tests of the GDLAM protocol and the GI have high interday test-retest reliability and good interday reproducibility. From a practical point of view, the GDLAM protocol allows the assessment of FA of community-dwelling OW, providing background for early diagnosis and, with it, the possibility of developing an individualized physical exercise prescription.

Experiences of Providers and Immigrants/Refugees with Health Care: A Meta-Synthesis of the Latin American Context.

INTRODUCTION: The experiences of providers and immigrants/refugees related to healthcare in the Latin American context have not yet been aggregated. This study aimed to synthesize the qualitative evidence on this theme. METHOD: A systematic review of qualitative evidence with meta-synthesis. After identification, eligible studies were evaluated for methodological quality, and information was systematically analyzed. RESULTS: The sample comprised 26 articles. The meta-theme shows that the experiences of providers and immigrants/refugees are determined by multilevel factors. In a macro-context, these factors involve the vulnerabilities of immigrants/refugees and the healthcare system/model, and in a closer context, they involve the lack of professional training in cultural skills and communication; language barriers; and prejudice/xenophobia. Within healthcare, the relationship is mostly conflictual, asymmetric, and unable to solve problems, leading to negative repercussions for both. CONCLUSIONS: Managers involved in developing public policies and providers must consider improving the interrelationship between healthcare services and the migrant population.

Re: Epidemiology of giant cell arteritis in Waikato, Aotearoa New Zealand.

The interest in epidemiological data on giant cell arteritis (GCA) increased both in New Zealand and in Latin America, resulting in updated articles like those here commented. Of more relevance are two very recent contributions by van Dantzig et al. with novel conclusive findings from their evaluations on GCA performed in the region of Waikato. The authors emphasised that the diagnosis of GCA remained stable in this region from 2014 to 2022, being uncommon among Maori, Pacific peoples and Asian ethnic groups. Short comments on some literature data from Argentina, Brazil, Colombia, Peru and Mexico about the systemic arteritis are here addressed to show the Latin American view. The authors strongly believe that this kind of report may enhance the general interest on diagnostic and management issues related to this very important systemic vasculitis.

Latin American Consensus on the Treatment of Head and Neck Cancer.

Head and neck squamous cell carcinoma (HNSCC) is well known as a serious health problem worldwide, especially in low-income countries or those with limited resources, such as most countries in Latin America. International guidelines cannot always be applied to a population from a large region with specific conditions. This study established a Latin American guideline for care of patients with head and neck cancer and presented evidence of HNSCC management considering availability and oncologic benefit. A panel composed of 41 head and neck cancer experts systematically worked according to a modified Delphi process on (1) document compilation of evidence-based answers to different questions contextualized by resource availability and oncologic benefit regarding Latin America (region of limited resources and/or without access to all necessary health care system infrastructure), (2) revision of the answers and the classification of levels of evidence and degrees of recommendations of all recommendations, (3) validation of the consensus through two rounds of online surveys, and (4) manuscript composition. The consensus consists of 12 sections: Head and neck cancer staging, Histopathologic evaluation of head and neck cancer, Head and neck surgery-oral cavity, Clinical oncology-oral cavity, Head and neck surgery-oropharynx, Clinical oncology-oropharynx, Head and neck surgery-larynx, Head and neck surgery-larynx/hypopharynx, Clinical oncology-larynx/hypopharynx, Clinical oncology-recurrent and metastatic head and neck cancer, Head and neck surgery-reconstruction and rehabilitation, and Radiation therapy. The present consensus established 48 recommendations on HNSCC patient care considering the availability of resources and focusing on oncologic benefit. These recommendations could also be used to formulate strategies in other regions like Latin America countries.

Human resources for health and maternal mortality in Latin America and the Caribbean over the last three decades: a systemic-perspective reflections.

BACKGROUND: The role of human resources for health in the operation of health systems is crucial. However, training and incorporating them into institutions is a complex process due to the continuous misalignment between the supply and demand of health personnel. Taking the case of the Latin American and Caribbean region countries, this comment discusses the relationship between the availability of human resources for health and the maternal mortality ratio for the period 1990-2021. It proposes the need to resume planning exercises from a systemic perspective that involves all areas of government and the private sector linked to the training and employment of health workers. MAIN TEXT: We used secondary data from a global source to show patterns in the relationship between these two aspects and identify gaps in the Latin American and Caribbean regions. The results show enormous heterogeneity in the response of regional health systems to the challenge of maternal mortality in the region. Although most countries articulated specific programs to achieve the reduction committed by all countries through the Millennium Development Goals, not all had the same capacity to reduce it, and practically none met the target. In addition, in the English Caribbean countries, we found significant increases in the number of health personnel that do not explain the increases in the maternal mortality rate during the period. CONCLUSIONS: The great lesson from the data shown is that some countries could articulate responses to the problem using available resources through effective strategies, considering the specific needs of their populations. Although variations in maternal mortality rate cannot be explained solely through the provision of health personnel, it is important to consider that it is critical to find new modalities on how human resources for health could integrate and create synergies with other resources to increase systems capacity to deliver care according to conditions in each country.

Lung Cancer Clinical Trials in Latin America in the Era of Cooperative Groups: A 20-Year Analysis.

PURPOSE: The aim of this study is to characterize lung cancer treatment clinical trials in Latin America before (January 2001-December 2011) and after (January 2012-December 2021) the organization of major Latin American oncology cooperative groups. MATERIALS AND METHODS: Interventional clinical trials were identified in ClinicalTrials.gov using the search terms "lung cancer," country filters for 20 Latin American countries, and study start dates January 1, 2001-December 31, 2011, and January 1, 2012-December 31, 2021. Clinical trials were categorized as either originating in Latin America (LA) or outside Latin America (non-LA) with participation of Latin American countries. Descriptive statistics, two-sided Z-scores, and chi-square analyses with 95% CIs were calculated. RESULTS: Overall, 273 clinical trials involving Latin American countries between 2001 and 2021 were identified. Comparing 2001-2011 with 2012-2021, there was an increase in total clinical trials (100 v 173; P < .001). Only 9% (26 of 273) of all trials were LA trials. There was a marked decrease in the proportion of LA trials (14% v 7%, P = .058) and estimated enrollment to LA trials (3,245 v 1,190 patients; P < .001). Recruiting of patients with EGFR (29% v 7%; P < .01) and KRAS (18% v 2%; P < .01) driver mutations also decreased. Trial participation was highest in Brazil, Mexico, Argentina, Chile, and Peru and increased over time: Brazil (61 v 108; 77% increase), Mexico (40 v 88; 120% increase), Argentina (50 v 78; 56% increase), Chile (25 v 57; 128% increase), and Peru (14 v 37; 164% increase). CONCLUSION: There was a significant increase in clinical trial participation by Latin American countries, from 2001-2011 to 2012-2021. However, there were few clinical trials which originated in Latin America or focused on patients with driver mutations.

Advanced renal cell carcinoma management: the Latin American Cooperative Oncology Group (LACOG) and the Latin American Renal Cancer Group (LARCG) consensus update.

PURPOSE: Renal cell carcinoma is an aggressive disease with a high mortality rate. Management has drastically changed with the new era of immunotherapy, and novel strategies are being developed; however, identifying systemic treatments is still challenging. This paper presents an update of the expert panel consensus from the Latin American Cooperative Oncology Group and the Latin American Renal Cancer Group on advanced renal cell carcinoma management in Brazil. METHODS: A panel of 34 oncologists and experts in renal cell carcinoma discussed and voted on the best options for managing advanced disease in Brazil, including systemic treatment of early and metastatic renal cell carcinoma as well as nonclear cell tumours. The results were compared with the literature and graded according to the level of evidence. RESULTS: Adjuvant treatments benefit patients with a high risk of recurrence after surgery, and the agents used are pembrolizumab and sunitinib, with a preference for pembrolizumab. Neoadjuvant treatment is exceptional, even in initially unresectable cases. First-line treatment is mainly based on tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs); the choice of treatment is based on the International Metastatic Database Consortium (IMCD) risk score. Patients at favourable risk receive ICIs in combination with TKIs. Patients classified as intermediate or poor risk receive ICIs, without preference for ICI + ICIs or ICI + TKIs. Data on nonclear cell renal cancer treatment are limited. Active surveillance has a place in treating favourable-risk patients. Either denosumab or zoledronic acid can be used for treating metastatic bone disease. CONCLUSION: Immunotherapy and targeted therapy are the standards of care for advanced disease. The utilization and sequencing of these therapeutic agents hinge upon individual risk scores and responses to previous treatments. This consensus reflects a commitment to informed decision-making, drawn from professional expertise and evidence in the medical literature.

Cuantificación de la carga de la enfermedad renal crónica en América Latina: una epidemia invisibilizada / Quantification of the burden of chronic kidney disease in Latin America: an invisible epidemic / Quantificação da carga da doença renal crônica na América Latina: uma epidemia invisível

[RESUMEN]. Objetivo. 1) Describir la carga de la enfermedad renal crónica en países de América Latina entre 1990 y 2019 y, 2) Estimar la correlación entre los años de vida saludables perdidos (AVISA) con el índice sociodemográfico y el índice de acceso y calidad de salud. Métodos. Análisis secundario y ecológico, basado en el Estudio de la Carga Global de Enfermedades, Lesiones y Factores de Riesgo 2019. Se reportaron las tasas estandarizadas de mortalidad, años perdidos por muertes prematuras (APMP), años de vida ajustados por discapacidad (AVAD) y AVISA por enfermedad renal crónica para 1990, 2005 y 2019. La información se desagregó por países, sexo, grupos etarios y subcausas. Resultados. Entre 1990 y 2019, la carga de la enfermedad renal crónica aumentó considerablemente en los países de América Latina, convirtiéndose en una de las principales causas de mortalidad y de AVISA. La tasa estandarizada de AVISA por enfermedad renal crónica se debió, en gran medida, al peso de las muertes prematuras más que a la discapacidad. En 2019, Nicaragua, El Salvador, México y Guatemala se destacaron por tener las tasas estandarizadas de mortalidad por enfermedad renal crónica y de AVISA más elevadas, mientras que Uruguay presentó las más bajas. Conclusiones. La enfermedad renal crónica es una epidemia invisibilizada que representa una carga excesiva, en mortalidad y AVISA, para los países de América Latina. Es indispensable aunar esfuerzos regionales para enfrentar la enfermedad, además de impulsar acciones locales que atiendan las particularidades de cada país.

[ABSTRACT]. Objective. 1) Describe the burden of chronic kidney disease in Latin American countries between 1990 and 2019; and 2) Estimate the correlation between disability-adjusted life years (DALYs) and the Sociodemogra- phic Index and the Healthcare Access and Quality Index. Methods. Secondary and ecological analysis, based on the 2019 Global Burden of Diseases, Injuries and Risk Factors Study. Standardized mortality rates, years of life lost to due to premature death (YLLs),years of healthy life lost due to disability (YLDs) and DALYs due to chronic kidney disease were reported for 1990, 2005, and 2019. Information was disaggregated by country, sex, age group, and sub-cause. Results. Between 1990 and 2019, the burden of chronic kidney disease increased considerably in Latin Ame- rican countries, becoming one of the main causes of mortality and DALYs. The standardized rate of DALYs for chronic kidney disease was largely due to the weight of premature deaths rather than disability. In 2019, Nica- ragua, El Salvador, Mexico, and Guatemala had the highest standardized mortality rates for chronic kidney disease and DALYs, while Uruguay had the lowest. Conclusions. Chronic kidney disease is an invisible epidemic that places an excessive burden in terms of mortality and DALYs on Latin American countries. It is essential to join forces to tackle the disease in the region, and promote local actions that address the particularities of each country.

[RESUMO]. Objetivo. 1) Descrever a carga da doença renal crônica nos países da América Latina entre 1990 e 2019 e 2) estimar a correlação entre os anos de vida saudável perdidos (AVISA), o índice sociodemográfico e o índice de acesso e qualidade da saúde. Métodos. Análise secundária e ecológica, baseada no estudo Carga Global de Doenças, Lesões e Fatores de Risco 2019 (GBD). Foram informadas taxas de mortalidade padronizadas, anos de vida perdidos por morte prematura (AVP) por morte prematura, anos de vida ajustados por incapacidade (AVAI) e AVISA devido a doença renal crônica de 1990, 2005 e 2019. Os dados foram desagregados por país, sexo, faixas etárias e causas subjacentes. Resultados. Entre 1990 e 2019, a carga de doença renal crônica aumentou consideravelmente nos países da América Latina, tornando-se uma das principais causas de mortalidade e de AVISA. A taxa padronizada de AVISA devido à doença renal crônica foi influenciada em grande parte pelo peso das mortes prematuras, e não da incapacidade. Em 2019, Nicarágua, El Salvador, México e Guatemala se destacaram por terem as maiores taxas padronizadas de mortalidade por doença renal crônica e AVISA, ao passo que Uruguai teve as menores taxas. Conclusões. A doença renal crônica é uma epidemia invisível, que representa uma carga excessiva em ter- mos de mortalidade e de AVISA para os países da América Latina. É essencial unir esforços na região para combater a doença, além de promover ações locais que atendam às particularidades de cada país.

Food insecurity and sociodemographic factors in Latin America during the COVID-19 pandemic / Inseguridad alimentaria y factores sociodemográficos en América Latina durante la pandemia de COVID-19 / Insegurança alimentar e fatores sociodemográficos na América Latina durante a pandemia de COVID-19

[ABSTRACT]. Objective. To understand the association of food insecurity with sociodemographic factors in a sample popu- lation in Latin America during the COVID-19 pandemic. Methods. This was a multicenter cross-sectional study conducted in 10 countries in Latin America using an online survey through various digital platforms from October 14, 2020 to February 15, 2021. Statistical analysis of data was performed by applying descriptive statistics, chi-square test, and logistic regression analysis. Results. Of a total of 6 357 surveys, 58.2% of respondents experienced food security, 29.3% were slightly food insecure, 9.2% were moderately food insecure, and 3.3% were severely food insecure. Concerning the association food insecurity and sociodemographic variables, there is a significant association in the variables studied, including area of residence, education level, occupation, number of persons in the household, house- hold with children younger than 10 years of age, and socioeconomic level. Conclusions. These findings indicate that sociodemographic factors associated with food insecurity during the COVID-19 pandemic in Latin America were rural residence; complete and incomplete basic and secondary schooling; occupation (homemaker, unemployed, and self-employed); low, medium-low, and medium socioeco- nomic level; household with more than four persons; and household with children younger than 10 years of age.

[RESUMEN]. Objetivo. Determinar la asociación de la inseguridad alimentaria con factores sociodemográficos en una muestra de población de América Latina durante la pandemia de COVID-19. Métodos. Se llevó a cabo un estudio transversal multicéntrico en diez países de América Latina mediante una encuesta en línea a través de diversas plataformas digitales, entre el 14 de octubre del 2020 y el 15 de febrero del 2021. Se realizó un análisis estadístico de los datos usando procedimientos de estadística descriptiva, la prueba ji al cuadrado y un análisis de regresión logística. Resultados. En un total de 6 357 encuestas, el 58,2% de las personas encuestadas gozaba de seguridad ali- mentaria, el 29,3% tenía una inseguridad alimentaria leve, el 9,2% una inseguridad alimentaria moderada y el 3,3% una inseguridad alimentaria grave. Por lo que respecta a la asociación entre la inseguridad alimentaria y las variables sociodemográficas, hay una asociación significativa para algunas de las variables estudiadas, como la zona de residencia, el nivel de estudios, la actividad laboral, el número de personas en el hogar, el hogar con menores de 10 años y el nivel socioeconómico. Conclusiones. Estos resultados indican que los factores sociodemográficos asociados a la inseguridad alimentaria durante la pandemia de COVID-19 en América Latina fueron la residencia en zonas rurales; la edu- cación primaria y secundaria completa o no; la actividad laboral (trabajo doméstico, personas desempleadas y trabajadores autónomos); el nivel socioeconómico bajo, medio bajo, y medio; el hogar con más de cuatro personas; y el hogar con menores de 10 años.

[RESUMO]. Objetivo. Compreender a relação entre insegurança alimentar e fatores sociodemográficos em uma amostra populacional da América Latina durante a pandemia de COVID-19. Métodos. Estudo transversal multicêntrico realizado em 10 países da América Latina por meio de uma pesquisa on-line conduzida em diferentes plataformas digitais de 14 de outubro de 2020 a 15 de fevereiro de 2021. A análise estatística dos dados foi realizada por meio da aplicação de estatísticas descritivas, teste qui-quadrado e análise de regressão logística. Resultados. De um total de 6 357 questionários, 58,2% dos entrevistados afirmaram ter segurança alimentar, 29,3% indicaram um nível de insegurança alimentar leve, 9,2% tinham insegurança alimentar moderada e 3,3%, insegurança alimentar grave. No que diz respeito à relação entre insegurança alimentar e variáveis sociodemográficas, há uma relação significativa com as variáveis estudadas, incluindo área de residência, nível de escolaridade, ocupação, número de pessoas no domicílio, domicílio com crianças com menos de 10 anos de idade e nível socioeconômico. Conclusões. Os achados apontam que os fatores sociodemográficos associados à insegurança alimentar durante a pandemia de COVID-19 na América Latina foram residência em zona rural; ensino fundamental e médio completo e incompleto; ocupação (do lar, desempregado(a) e autônomo(a)); nível socioeconômico baixo, médio-baixo e médio; domicílio com mais de quatro pessoas; e domicílio com crianças menores de 10 anos de idade.

Mental health among adolescents exposed to social inequality in Latin America and the Caribbean: a scoping review.

Background and objective: Adolescents from Latin America and the Caribbean grow up in a context of social inequality, which diminishes their well-being and leads to impaired emotional-cognitive development. To understand the problem, it is important to synthesize the available research about it. This study aims to explore the knowledge about adolescents' mental health in Latin America and the Caribbean exposed to social inequality. Methods: A systematic scoping review was conducted encompassing a search in five databases (Medline, CINAHL, PsycINFO, Scopus, and LILACS) in June 2022. Articles of various typologies were included without time limit. After two rounds of screening, relevant data were manually extracted and synthesized into self-constructed themes using thematic analysis. Results: Out of 8,825 retrieved records, 42 papers were included in the final review, with a predominance of quantitative approaches. The synthesis revealed two main analytical themes: (a) defining social inequality, wherein intersecting inequalities produce discrimination and determine conditions for social vulnerability; (b) social inequality and mental health, which highlights the association between socio-structural difficulties and emotional problems, amplifying vulnerability to mental ill health and poor mental health care. Conclusion: The scientific evidence reveals that social inequality is related to impaired well-being and mental ill health on the one hand and a lack of access to mental health care on the other hand.

Prevalence and incidence of diabetic retinopathy in patients with diabetes of Latin America and the Caribbean: A systematic review and meta-analysis.

OBJECTIVES: This systematic review aimed to assess the prevalence and incidence of diabetic retinopathy in patients with diabetes of Latin America and the Caribbean. METHODS: We searched Web of Science (WoS)/Core Collection, WoS/MEDLINE, WoS/Scielo, Scopus, PubMed/Medline and Embase databases until January 16, 2023. We meta-analyzed prevalences according to type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). RESULTS: Forty-three prevalence studies (47 585 participants) and one incidence study (436 participants) were included. The overall prevalence of retinopathy in patients with T1DM was 40.6% (95% CI: 34.7 to 46.6; I2: 92.1%) and in T2DM was 37.3% (95% CI: 31.0 to 43.8; I2: 97.7), but the evidence is very uncertain (very low certainty of evidence). In meta-regression, we found that age (T1DM) and time in diabetes (T2DM) were factors associated with the prevalence. On the other hand, one study found a cumulative incidence of diabetic retinopathy of 39.6% at 9 years of follow-up. CONCLUSIONS: Two out of five patients with T1DM or T2DM may present diabetic retinopathy in Latin America and the Caribbean, but the evidence is very uncertain. This is a major public health problem, and policies and strategies for early detection and opportunely treatment should be proposed.

[Core data set for real world data in multiple sclerosis: customization for latin america from a global task force recommendation]. / Core data set para la generación de datos de la vida real en esclerosis múltiple: adaptación de una iniciativa global para América Latina.

INTRODUCTION: The primary objective of the core data set is to reduce heterogeneity and promote harmonization among data sources in EM, thereby reducing the time needed to execute real life data collection efforts. Recently, a group led by the Multiple Sclerosis Data Alliance has developed a core data set for collecting real-world data on multiple sclerosis (MS) globally. Our objective was to adapt this global data set to the needs of Latin America, so that it can be implemented by the registries already developed and in the process of development in the region. MATERIAL AND METHODS: A working group was formed regionally, the core data set created globally was adapted (translation process into Spanish, incorporation of regional variables and consensus on variables to be used). Consensus was obtained through the remote Delphi methodology of a round of questionnaires and remote discussion of the core data set variables. RESULTS: A total of 25 professionals from Latin America carried out the adaptation process between November 2022 and July 2023. Agreement was established on a core data set of nine categories and 45 variables, version 2023 to suggest its implementation in developed or developing registries, and MS cohorts in the region. CONCLUSION: The core data set seeks to harmonize the variables collected by registries and cohorts in MS in Latin America in order to facilitate said collection and allow collaboration between sources. Its implementation will facilitate real life data collection and collaboration in the region.

TITLE: Core data set para la generación de datos de la vida real en esclerosis múltiple: adaptación de una iniciativa global para América Latina.Introducción. Los objetivos primarios del core data set son reducir la heterogeneidad y promover la armonización entre las fuentes de datos en la esclerosis múltiple (EM), reduciendo así el tiempo necesario para ejecutar esfuerzos en la recolección de datos de vida real. Recientemente, un grupo liderado por la Multiple Sclerosis Data Alliance ha desarrollado un core data set para la recolección de datos del mundo real en EM a nivel global. Nuestro objetivo ha sido adaptar y consensuar este conjunto de datos globales a las necesidades de América Latina para que pueda ser implementado por los registros ya desarrollados y en proceso de desarrollo en la región. Material y métodos. Se conformó un grupo de trabajo regionalmente y se adaptó el core data set creado globalmente (proceso de traducción al español, incorporación de variables regionales y consenso sobre variables que se iban a utilizar). El consenso se obtuvo a través de la metodología Delphi remoto de ronda de cuestionarios y discusión a distancia de las variables del core data set. Resultados. Veinticinco profesionales de América Latina llevaron adelante el proceso de adaptación entre noviembre de 2022 y julio de 2023. Se estableció un acuerdo sobre un core data set de nueve categorías y 45 variables, versión 2023, con la sugerencia de implementarlo en registros desarrollados o en vías de desarrollo y cohortes de EM en la región. Conclusión. El core data set busca armonizar las variables recolectadas por los registros y las cohortes de EM en América Latina con el fin de facilitar dicha recolección y permitir una colaboración entre fuentes. Su implementación facilitará la recolección de datos de vida real y la colaboración en la región.

Self-perception of mental health, COVID-19 and associated sociodemographic-contextual factors in Latin America.

This study aimed to estimate the prevalence of alterations in self-perceived mental health during the COVID-19 pandemic and their associated factors in four Latin American countries. This is a cross-sectional study based on data collected from adults in 2021 through the Collaborative Response COVID-19 Survey by the MacDonnell Academy at Washington University in St. Louis (United States). The sample was composed of 8,125 individuals from Brazil, Colombia, Mexico, and Chile. A generalized linear model for a binary outcome variable with a logistic link and fixed country effects was used. There were 2,336 (28.75%) individuals who considered having suffered alterations in self-perceived mental health. Unemployed individuals (OR = 1.40; 95%CI: 1.24-1.58), those with bad/regular quality of life (OR = 5.03; 95%CI: 4.01-6.31), and those with high socioeconomic status (OR = 1.66; 95%CI: 1.41-1.96) had a higher risk of self-perceived mental health alterations than those with full-time employment, excellent quality, and low socioeconomic status. According to the fixed-effects model, Brazilians living in the country during the pandemic, who disagreed with their government's decisions (OR = 2.05; 95%CI: 1.74-2.42) and lacked trust in their government (OR = 2.10; 95%CI: 1.74-2.42) had a higher risk of having self-perceived mental health alterations. Nearly 30% of respondents indicated that the COVID-19 pandemic altered their self-perceived mental health. This outcome was associated with political, sociodemographic, and health risk factors. These findings should help policymakers develop post-pandemic community interventions.