Real-world effectiveness of the CoronaVac vaccine in a retrospective population-based cohort in four Colombian cities (2021-2022).

OBJECTIVES: The National Vaccination Plan against SARS-CoV-2/COVID-19 was launched by the Ministry of Health and Social Protection on 14 February 2021. The main objective of this study was to evaluate the effectiveness of the CoronaVac in preventing the three clinical outcomes of infection, hospitalisation, or death, in a real-world scenario. DESIGN: This was a population-based retrospective dynamic cohort study using a multivariate Cox model to calculate hazard ratios to estimate vaccine effectiveness from 17 February 2021 to 30 June 2022. The data were collected from surveillance systems for 12 months for each individual. Four cities were selected on the basis of the reliability of their data bases. RESULTS: The rates of CoronaVac effectiveness were 32% (95% confidence interval [CI] 31-33) for preventing infection, 55% (95% CI 54-56) for hospitalisation, and 90% (95% CI 89-90) for death, at the end of follow-up. These findings were more consistent during the first 4 months. Compared with the unvaccinated group, homologous booster doses appeared to increase effectiveness in preventing hospitalisation, whereas heterologous booster doses increased protection for both hospitalisation and death. Booster doses did not improve effectiveness among those already vaccinated with CoronaVac, even when they received heterologous boosters. CONCLUSIONS: CoronaVac demonstrated effectiveness in preventing death and hospitalisation during the first year of follow-up, but its effectiveness in preventing infection was lower, decreasing rapidly after the first 4 months of follow-up. The effectiveness was higher among children aged between 3 and 12 years, and among adults aged ≥60 years. Booster doses did not improve effectiveness among those already vaccinated with CoronaVac.

How has research on the effectiveness and safety of COVID-19 vaccination been evaluated: a scope review with emphasis on CoronaVac.

Introduction: The control of the COVID-19 epidemic has been focused on the development of vaccines against SARS-CoV-2. All developed vaccines have reported safety and efficacy results in preventing infection and its consequences, although the quality of evidence varies depending on the vaccine considered. Different methodological designs have been used for their evaluation, which can influence our understanding of the effects of these interventions. CoronaVac is an inactivated vaccine, and it has been assessed in various studies, including clinical trials and observational studies. Given these differences, our objective was to explore the published information to answer the question: how has the efficacy/effectiveness and safety of CoronaVac been evaluated in different studies? This is to identify potential gaps and challenges to be addressed in understanding its effect. Methods: A scoping review was carried out following the methodology proposed by the Joanna Briggs Institute, which included studies carried out in humans as of 2020, corresponding to systematic reviews, clinical trials, analytical or descriptive observational studies, in which the effectiveness and/or safety of vaccines for COVID19 were evaluated or described. There were no age restrictions for the study participants. Results: The efficacy/effectiveness and safety of this vaccine was assessed through 113 studies. Nineteen corresponded to experimental studies, 7 of Phase II, 5 of Phase IV, and 4 were clinical trials with random assignment. Although some clinical trials with random assignment have been carried out, these have limitations in terms of feasibility, follow-up times, and with this, the possibility of evaluating safety outcomes that occur with low frequencies. Not all studies have used homogeneous methods of analysis. Both the prevention of infection, and the prevention of outcomes such as hospitalization or death, have been valued through similar outcomes, but some through multivariate analysis of dependencies, and others through analysis that try to infer causally through different control methods of confounding. Conclusion: Published information on the evaluation of the efficacy/effectiveness and safety of the CoronaVac is abundant. However, there are differences in terms of vaccine application schedules, population definition, outcomes evaluated, follow-up times, and safety assessment, as well as non-standardization in the reporting of results, which may hinder the generalizability of the findings. It is important to generate meetings and consensus strategies for the methods and reporting of this type of studies, which will allow to reduce the heterogeneity in their presentation and a better understanding of the effect of these vaccines.

Involving patients in drug development for Neglected Tropical Diseases (NTDs): A qualitative study exploring and incorporating preferences of patients with cutaneous leishmaniasis into Target Product Profile development.

BACKGROUND: Target Product Profiles (TPPs) are instrumental to help optimise the design and development of therapeutics, vaccines, and diagnostics - these products, in order to achieve the intended impact, should be aligned with users' preferences and needs. However, patients are rarely involved as key stakeholders in building a TPP. METHODOLOGY: Thirty-three cutaneous leishmaniasis (CL) patients from Brazil, Colombia, and Austria, infected with New-World Leishmania species, were recruited using a maximum variation approach along geographic, sociodemographic and clinical criteria. Semi-structured interviews were conducted in the respective patient's mother tongue. Transcripts, translated into English, were analysed using a framework approach. We matched disease experiences, preferences, and expectations of CL patients to a TPP developed by DNDi (Drug for Neglected Diseases initiative) for CL treatment. PRINCIPAL FINDINGS: Patients' preferences regarding treatments ranged from specific efficacy and safety endpoints to direct and significant indirect costs. Respondents expressed views about trade-offs between efficacy and experienced discomfort/adverse events caused by treatment. Reasons for non-compliance, such as adverse events or geographical and availability barriers, were discussed. Considerations related to accessibility and affordability were relevant from the patients' perspective. CONCLUSIONS/SIGNIFICANCE: NTDs affect disadvantaged populations, often with little access to health systems. Engaging patients in designing adapted therapies could significantly contribute to the suitability of an intervention to a specific context and to compliance, by tailoring the product to the end-users' needs. This exploratory study identified preferences in a broad international patient spectrum. It provides methodological guidance on how patients can be meaningfully involved as stakeholders in the construction of a TPP of therapeutics for NTDs. CL is used as an exemplar, but the approach can be adapted for other NTDs.

Inequalities in the health, nutrition, and wellbeing of Afrodescendant women and children: A cross-sectional analysis of ten Latin American and Caribbean countries.

Background: Afrodescendants are systematically affected by discrimination in the Americas and few multi-country studies addressed ethnic inequalities in health and wellbeing in the region. We aimed to investigate gaps in coverage of key health outcomes and socioeconomic inequalities between Afrodescendants and non-Afrodescendants populations in Latin American and Caribbean countries. Methods: Using national household surveys (2011-2019) from ten countries, we analyzed absolute inequalities between Afrodescendants and a comparison group that includes non-Afrodescendants and non-Indigenous individuals (henceforth non-Afrodescendants) across 17 indicators in the continuum of reproductive, maternal, newborn, child, and adolescent health. These include indicators of family planning, antenatal care, delivery assistance, child nutrition, immunization coverage, child protection, access to improved water, sanitation and hygiene, adolescent fertility, and early childhood mortality. Inequalities between country-specific subgroups of Afrodescendants were also explored. The slope index of inequality was used to assess wealth-based inequalities within each ethnic group. Findings: Afrodescendants represented from 2·8% (Honduras) to 59·1% (Brazil) of the national samples. Of the 128 combinations of country and indicators with data, Afrodescendants fared worse in 78 (of which 33 were significant) and performed better in 50 (15 significant). More systematic disadvantages for Afrodescendants were found for demand for family planning satisfied, early marriage, and household handwashing and sanitation facilities. In contrast, Afrodescendants tended to present lower c-section rates and lower stunting prevalence. Honduras was the only country where Afrodescendants performed better than non-Afrodescendants in several indicators. Wealth gaps among Afrodescendants were wider than those observed for non-Afrodescendants for most indicators and across all countries. Interpretation: Gaps in health outcomes between Afrodescendants and non-Afrodescendants were observed in most countries, with more frequent disadvantages for the former although, in many cases, the gaps were reversed. Wealth inequalities within Afrodescendants tended to be wider than for non-Afrodescendants. Funding: Pan American Health Organization, Bill and Melinda Gates Foundation, and the Wellcome Trust.

La iniciativa Todas las Mujeres Todos los Niños brinda apoyo a los países de América Latina y el Caribe para reducir las desigualdades sociales en la salud

[RESUMEN]. La iniciativa Todas las Mujeres Todos los Niños América Latina y el Caribe (EWEC-LAC, por su sigla en inglés) se estableció en el 2017 como un mecanismo interinstitucional regional. Coordina la implementación regional de la Estrategia Mundial para la Salud de la Mujer, el Niño y el Adolescente 2016-2030 en América Latina y el Caribe (ALC), lo que incluye su adaptación a necesidades específicas de la Región, para poner fin a las muertes evitables, garantizar la salud y el bienestar, y ampliar los entornos propicios para la salud y el bienestar de mujeres, niños y adolescentes. Para promover el logro equitativo de estos objetivos, los tres grupos de trabajo de EWEC-LAC apoyan colectivamente a los países de ALC en la medición y el monitoreo de las desigualdades sociales en la salud, la promoción de la disminución de estas y el diseño e implementación de estrategias, políticas e intervenciones orientadas a la equidad. Este apoyo para cerrar las brechas actuales asegura que nadie se quede atrás. Los miembros de la iniciativa EWEC-LAC incluyen al UNFPA, la OPS, ONU-Mujeres, ONUSIDA, UNICEF, el Banco Mundial, el Banco Interamericano de Desarrollo, USAID, la Alianza Regional Neonatal para ALC y el Grupo de Trabajo Regional para la Reducción de la Mortalidad Materna. A la fecha, EWEC-LAC ha desarrollado y recopilado herramientas y recursos innovadores, y ha comenzado a colaborar con los países para utilizarlos a fin de reducir las brechas en la equidad. Estos incluyen un marco de medición de las desigualdades sociales en la salud, herramientas de promoción de datos, como un tablero de datos para visualizar tendencias en las desigualdades sociales en la salud, una metodología para establecer metas en la disminución de las desigualdades, y un compendio de herramientas y métodos para identificar y abordar las desigualdades sociales en la salud. EWEC-LAC ha trabajado en la Región para enfatizar la importancia de reconocer estas desigualdades a los niveles sociales y políticos, y ha abogado por su disminución. La atención para cerrar las brechas de equidad en la salud es cada vez más crítica frente a la pandemia de COVID-19, que ha agudizado las vulnerabilidades existentes. Los sistemas de salud más equitativos estarán mejor preparados para hacer frente a futuras crisis de salud.

[ABSTRACT]. Every Woman Every Child Latin America and the Caribbean (EWEC-LAC) was established in 2017 as a regio- nal inter-agency mechanism. EWEC-LAC coordinates the regional implementation of the Global Strategy for Women’s, Children’s and Adolescents’ Health in Latin America and the Caribbean (LAC), including adapta- tion to region specific needs, to end preventable deaths, ensure health and well-being and expand enabling environments for the health and well-being of women, children and adolescents. To advance the equitable achievement of these objectives, EWEC-LAC’s three working groups collectively support LAC countries in measuring and monitoring social inequalities in health, advocating for their reduction, and designing and implementing equity-oriented strategies, policies and interventions. This support for data-driven advocacy, capacity building, and policy and program solutions toward closing current gaps ensures that no one is left behind. Members of EWEC-LAC include PAHO, UNAIDS, UNFPA, UNICEF, UN WOMEN, the World Bank, the Inter-American Development Bank, USAID, LAC Regional Neonatal Alliance, and the LAC Regional Task Force for the Reduction of Maternal Mortality. To date, EWEC-LAC has developed and collected innovative tools and resources and begun to engage with countries to utilize them to reduce equity gaps. These resources include a framework for the measurement of social inequalities in health, data use and advocacy tools including a data dashboard to visualize trends in social inequalities in health in LAC countries, a methodology for setting targets for the reduction of inequalities, and a compendium of tools, instruments and methods to identify and address social inequalities in health. EWEC-LAC has also engaged regionally to emphasize the importance of recogni- zing these inequalities at social and political levels, and advocated for the reduction of these gaps. Attention to closing health equity gaps is ever more critical in the face of the COVID-19 pandemic which has exploited existing vulnerabilities. More equitable health systems will be better prepared to confront future health shocks.

[RESUMO]. A iniciativa “Todas as mulheres, todas as crianças da América Latina e Caribe” (EWEC-LAC, na sigla em inglês) foi criada em 2017 como um mecanismo interinstitucional regional. Coordena a implementação regio- nal da Estratégia Mundial para a Saúde da Mulher, da Criança e do Adolescente 2016-2030 na América Latina e Caribe (ALC), incluindo sua adaptação a necessidades específicas da região, para acabar com as mortes evitáveis, garantir a saúde e o bem-estar e expandir ambientes propícios para a saúde e o bem-estar de mulheres, crianças e adolescentes. Para promover o alcance equitativo desses objetivos, os três grupos de trabalho da EWEC-LAC apoiam coletivamente os países da ALC com a medição e o monitoramento das desigualdades sociais de saúde, a promoção de sua redução, e o delineamento e a implementação de estra- tégias, políticas e intervenções voltadas para a equidade. Esse apoio para fechar as lacunas atuais assegura que ninguém seja deixado para trás. Os membros da iniciativa EWEC-LAC incluem UNFPA, OPAS, ONU Mulheres, UNAIDS, UNICEF, Banco Mundial, Banco Interamericano de Desenvolvimento, USAID, Aliança Neonatal Regional para ALC e Grupo de Trabalho Regional para a Redução da Mortalidade Materna. Até o momento, a EWEC-LAC desenvolveu e compilou ferramentas e recursos inovadores e começou a colaborar com os países para utilizá-los a fim de reduzir as lacunas de equidade. Isso inclui uma estrutura de medição das desigualdades sociais de saúde, ferramentas de promoção de dados (como um painel de dados para visualizar tendências nas desigualdades sociais de saúde), uma metodologia para estabelecer metas para reduzir as desigualdades e um compêndio de ferramentas e métodos para identificar e abordar as des- igualdades sociais de saúde. A EWEC-LAC trabalhou na região para enfatizar a importância de reconhecer essas desigualdades nos níveis social e político, e defendeu sua redução. A atenção para o fechamento das lacunas de equidade na saúde é cada vez mais crítica frente à pandemia de COVID-19, que exacerbou as vulnerabilidades existentes. Sistemas de saúde mais equitativos estarão mais bem preparados para lidar com futuras crises de saúde.

La iniciativa Todas las Mujeres Todos los Niños brinda apoyo a los países de América Latina y el Caribe para reducir las desigualdades sociales en la salud / The Every Woman Every Child initiative: supporting countries in Latin America and the Caribbean to reduce social inequalities in health / A iniciativa "Todas as mulheres, todas as crianças" oferece apoio aos países da América Latina e Caribe para reduzir as desigualdades sociais de saúde

resumen está disponible en el texto completo

ABSTRACT Every Woman Every Child Latin America and the Caribbean (EWEC-LAC) was established in 2017 as a regional inter-agency mechanism. EWEC-LAC coordinates the regional implementation of the Global Strategy for Women's, Children's and Adolescents' Health in Latin America and the Caribbean (LAC), including adaptation to region specific needs, to end preventable deaths, ensure health and well-being and expand enabling environments for the health and well-being of women, children and adolescents. To advance the equitable achievement of these objectives, EWEC-LAC's three working groups collectively support LAC countries in measuring and monitoring social inequalities in health, advocating for their reduction, and designing and implementing equity-oriented strategies, policies and interventions. This support for data-driven advocacy, capacity building, and policy and program solutions toward closing current gaps ensures that no one is left behind. Members of EWEC-LAC include PAHO, UNAIDS, UNFPA, UNICEF, UN WOMEN, the World Bank, the Inter-American Development Bank, USAID, LAC Regional Neonatal Alliance, and the LAC Regional Task Force for the Reduction of Maternal Mortality. To date, EWEC-LAC has developed and collected innovative tools and resources and begun to engage with countries to utilize them to reduce equity gaps. These resources include a framework for the measurement of social inequalities in health, data use and advocacy tools including a data dashboard to visualize trends in social inequalities in health in LAC countries, a methodology for setting targets for the reduction of inequalities, and a compendium of tools, instruments and methods to identify and address social inequalities in health. EWEC-LAC has also engaged regionally to emphasize the importance of recognizing these inequalities at social and political levels, and advocated for the reduction of these gaps. Attention to closing health equity gaps is ever more critical in the face of the COVID-19 pandemic which has exploited existing vulnerabilities. More equitable health systems will be better prepared to confront future health shocks.

RESUMO A iniciativa "Todas as mulheres, todas as crianças da América Latina e Caribe" (EWEC-LAC, na sigla em inglês) foi criada em 2017 como um mecanismo interinstitucional regional. Coordena a implementação regional da Estratégia Mundial para a Saúde da Mulher, da Criança e do Adolescente 2016-2030 na América Latina e Caribe (ALC), incluindo sua adaptação a necessidades específicas da região, para acabar com as mortes evitáveis, garantir a saúde e o bem-estar e expandir ambientes propícios para a saúde e o bem-estar de mulheres, crianças e adolescentes. Para promover o alcance equitativo desses objetivos, os três grupos de trabalho da EWEC-LAC apoiam coletivamente os países da ALC com a medição e o monitoramento das desigualdades sociais de saúde, a promoção de sua redução, e o delineamento e a implementação de estratégias, políticas e intervenções voltadas para a equidade. Esse apoio para fechar as lacunas atuais assegura que ninguém seja deixado para trás. Os membros da iniciativa EWEC-LAC incluem UNFPA, OPAS, ONU Mulheres, UNAIDS, UNICEF, Banco Mundial, Banco Interamericano de Desenvolvimento, USAID, Aliança Neonatal Regional para ALC e Grupo de Trabalho Regional para a Redução da Mortalidade Materna. Até o momento, a EWEC-LAC desenvolveu e compilou ferramentas e recursos inovadores e começou a colaborar com os países para utilizá-los a fim de reduzir as lacunas de equidade. Isso inclui uma estrutura de medição das desigualdades sociais de saúde, ferramentas de promoção de dados (como um painel de dados para visualizar tendências nas desigualdades sociais de saúde), uma metodologia para estabelecer metas para reduzir as desigualdades e um compêndio de ferramentas e métodos para identificar e abordar as desigualdades sociais de saúde. A EWEC-LAC trabalhou na região para enfatizar a importância de reconhecer essas desigualdades nos níveis social e político, e defendeu sua redução. A atenção para o fechamento das lacunas de equidade na saúde é cada vez mais crítica frente à pandemia de COVID-19, que exacerbou as vulnerabilidades existentes. Sistemas de saúde mais equitativos estarão mais bem preparados para lidar com futuras crises de saúde.

Factors Associated With Low Physical Activity in Two Latin American Populations at Risk of Developing Type 2 Diabetes: An Exploratory Analysis.

Low level of physical activity is a risk factor for chronic non-communicable diseases. Specifically, people at risk of Type 2 Diabetes (T2D) have shown to benefit from being physically active. The objective of this study was to explore what factors were associated with low physical activity in people at high risk of T2D living in Bogota and Barranquilla, Colombia. Methodology: Cross-sectional study using baseline data from a quasi-experimental clinical trial (PREDICOL Project). The study included 1,135 participants of Bogota and Barranquilla that presented a high risk of developing T2D according to the Finnish Diabetes Risk Score (>12 points) and who underwent an oral glucose tolerance test. The main outcome variable was the level of physical activity assessed by the International Physical Activity Questionnaire. Unadjusted and adjusted logistic regression analysis were used to calculate odds ratios (OR) and the corresponding 95% confidence intervals (CI). Results: In total, 72.5% of the study participants had low level of physical activity. Participants in the age group between 45 and 54 years showed 74% greater odds of having low physical activity compared with the youngest age group (OR 1.74, 95% CI 1.1 -2.8). People living in Barranquilla were eight times more likely to have low physical activity compared with those in Bogotá D.C. (OR 8.1, 95% CI 5.7 to 11.4). Conclusion: A large proportion of the population at risk of developing D2T in two large cities of Colombia have a sedentary lifestyle. Interventions should be designed and implemented in order to increase physical activity in these populations.

Eligibility criteria and outcome measures adopted in clinical trials of treatments of cutaneous leishmaniasis: systematic literature review covering the period 1991-2015.

OBJECTIVE: To document the sources of heterogeneity in outcomes and shortcomings in trial designs reported by previous systematic reviews. METHODS: Systematic review of clinical trials of CL treatments published since 1991, to assess and compare eligibility criteria and outcome measures in trials (any type of treatment) of CL (any form) reported before and after the publication of the CONSORT statement. RESULTS: We identified 106 eligible trials published between 1991 and 2015, 74% after the 2001 CONSORT statement; 58% (n = 63) were on Old-World CL and 37% (n = 40) in New-World CL; overall, 11 531 patients enrolled in 243 treatment groups on 30 different treatments. Both requirements and definitions for eligibility and outcome criteria varied. Compliance with CONSORT requirements increased for studies published after the 2010 update. As for entry criteria, 94% of studies had a requirement for sex (74% of those enrolling also women excluded those who were pregnant or lactating), 69% for age (variable age ranges), 99% parasitological confirmation, 43% prior duration of illness (14% excluded cases with previous episodes), 46% defined the number, 28% the size and 13% the type of lesions (27% with restrictions as to their anatomical location). Follow-up ranged 1-24 months, with 14% and 91% of studies, respectively, having defined initial and final cure. CONCLUSIONS: This review documents changes in reporting before and after the publication of the CONSORT statement. Lack of standardisation, compounded with the small number of trials relative to the magnitude of the disease in its multiple forms, and with the range of treatments tested explains why evidence to inform treatment guidelines is generally weak for CL. Adopting standardised methodologies will improve the quality and consistency of clinical trials, and ultimately yield better treatments for CL.

Comprehensive economic evaluation of thermotherapy for the treatment of cutaneous leishmaniasis in Colombia.

BACKGROUND: Cutaneous leishmaniasis causes a high disease burden in Colombia, and available treatments present systemic toxicity, low patient compliance, contraindications, and high costs. The purpose of this study was to estimate the cost-effectiveness of thermotherapy versus Glucantime in patients with cutaneous leishmaniasis in Colombia. METHODS: Cost-effectiveness study from an institutional perspective in 8133 incident cases. Data on therapeutic efficacy and safety were included, calculating standard costs; the outcomes were disability adjusted life years (DALYs) and the number of patients cured. The information sources were the Colombian Public Health Surveillance System, disease burden studies, and one meta-analysis of controlled clinical trials. Incremental cost-effectiveness was determined, and uncertainty was evaluated with tornado diagrams and Monte Carlo simulations. RESULTS: Thermotherapy would generate costs of US$ 501,621; the handling of adverse effects, US$ 29,224; and therapeutic failures, US$ 300,053. For Glucantime, these costs would be US$ 2,731,276, US$ 58,254, and US$ 406,298, respectively. With thermotherapy, the cost would be US$ 2062 per DALY averted and US$ 69 per patient cured; with Glucantime, the cost would be US$ 4241 per DALY averted and US$ 85 per patient cured. In Monte Carlo simulations, thermotherapy was the dominant strategy for DALYs averted in 67.9% of cases and highly cost-effective for patients cured in 72%. CONCLUSION: In Colombia, thermotherapy can be included as a cost-effective strategy for the management of cutaneous leishmaniasis. Its incorporation into clinical practice guidelines could represent savings of approximately US$ 10,488 per DALY averted and costs of US$ 116 per additional patient cured, compared to the use of Glucantime. These findings show the relevance of the incorporation of this treatment in our country and others with similar parasitological, clinical, and epidemiological patterns.

Cost-effectiveness analysis of thermotherapy versus pentavalent antimonials for the treatment of cutaneous leishmaniasis.

OBJECTIVE: The treatment of cutaneous leishmaniasis is toxic, has contraindications, and a high cost. The objective of this study was to estimate the cost-effectiveness of thermotherapy versus pentavalent antimonials for the treatment of cutaneous leishmaniasis. METHODS: Effectiveness was the proportion of healing and safety with the adverse effects; these parameters were estimated from a controlled clinical trial and a meta-analysis. A standard costing was conducted. Average and incremental cost-effectiveness ratios were estimated. The uncertainty regarding effectiveness, safety, and costs was determined through sensitivity analyses. RESULTS: The total costs were $66,807 with Glucantime and $14,079 with thermotherapy. The therapeutic effectiveness rates were 64.2% for thermotherapy and 85.1% for Glucantime. The average cost-effectiveness ratios ranged between $721 and $1275 for Glucantime and between $187 and $390 for thermotherapy. Based on the meta-analysis, thermotherapy may be a dominant strategy. CONCLUSION: The excellent cost-effectiveness ratio of thermotherapy shows the relevance of its inclusion in guidelines for the treatment.

Guía de práctica clínica para el tratamiento de la diabetes mellitus tipo 2: manejo inicial / Clinical Practice Guideline for Treatment of Type 2 Diabetes Mellitus: Initial Treatment

Introducción: En la actualidad es ampliamente aceptada la metformina como manejo farmacológico inicial para el tratamiento de la diabetes mellitus tipo 2 (DMT2). Resulta, sin embargo, controversial si en algunos tipos de pacientes puede iniciarse tratamiento únicamente con cambios intensivos de estilo de vida o si existen grupos en quienes debería iniciarse desde el inicio terapia farmacológica combinada. Objetivo: Definir el impacto de estrategias de cambio intensivo en la dieta y de ejercicio, así como de la terapia farmacológica con metformina asociada a un segundo antidiabético oral como estrategias de manejo inicial en pacientes con DMT2 recién diagnosticada. Métodos: Se elaboró la guía de práctica clínica, siguiendo los lineamientos de la guía metodológica del Ministerio de Salud y Protección Social colombiano. Se revisó la evidencia disponible de forma sistemática y se formularon las recomendaciones utilizando la metodología GRADE. Conclusiones: En pacientes con DMT2 recién diagnosticada no se recomienda el manejo únicamente con cambios intensivos del estilo de vida; estos deben acompañar el manejo farmacológico con metformina, dando prelación a los componentes de la dieta mediterránea y al ejercicio aeróbico. En los pacientes con DMT2 recién diagnosticada y niveles de HbA1C > 8 % se recomienda utilizar terapia combinada desde el inicio con metformina y otro antidiabético oral, siendo de primera elección los inhibidores de DPP-4.

Introduction: Today, metformin is widely accepted as standard initial pharmacologic treatment for diabetes mellitus type 2 (DMT2). However, it is controversial if in some groups of patients, the treatment can be initiated only with life style changes, or if there are groups who should begin with combined therapy since the beginning. Aim: To define the effect of intensive strategies for change of diet or exercise, and the effect of combined therapy with metformin and a second oral antidiabetic, as initial treatment in patients with newly DMT2. Methods: A clinical practice guide has been developed following the broad outline of the methodological guide from the Colombian Ministry of Health and Social Welfare. with the aim of systematically gathering scientific evidence and formulating recommendations using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. Conclusions: In patients with recently diagnosed DMT2, initial treatment with lifestyle changes only is not recommended. However, it is recommended that lifestyles changes must begin simultaneously with metformin, including the components of a Mediterranean diet and aerobic exercise. In patients with recently diagnosed DMT2 and HbA1c levels >8%, it is recommended to administer a combined therapy from the beginning with metformin and another oral antidiabetic medication. The DPP4 inhibitor is recommended.

Clinical practice guideline for the prevention, early detection, diagnosis, management and follow up of type 2 diabetes mellitus in adults.

In Colombia, diabetes mellitus is a public health program for those responsible for creating and implementing strategies for prevention, diagnosis, treatment, and follow-up that are applicable at all care levels, with the objective of establishing early and sustained control of diabetes. A clinical practice guide has been developed following the broad outline of the methodological guide from the Ministry of Health and Social Welfare, with the aim of systematically gathering scientific evidence and formulating recommendations using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. The current document presents in summary form the results of this process, including the recommendations and the considerations taken into account in formulating them. In general terms, what is proposed here is a screening process using the Finnish Diabetes Risk Score questionnaire adapted to the Colombian population, which enables early diagnosis of the illness, and an algorithm for determining initial treatment that can be generalized to most patients with diabetes mellitus type 2 and that is simple to apply in a primary care context. In addition, several recommendations have been made to scale up pharmacological treatment in those patients that do not achieve the objectives or fail to maintain them during initial treatment. These recommendations also take into account the evolution of weight and the individualization of glycemic control goals for special populations. Finally, recommendations have been made for opportune detection of micro- and macrovascular complications of diabetes.

En Colombia la Diabetes Mellitus es un problema de salud pública por lo que deben generarse e implementarse estrategias de prevención, diagnóstico, tratamiento y seguimiento, aplicables en todos los niveles de atención con miras a establecer el control de la diabetes en forma temprana y sostenida. Se elaboró una guía de práctica clínica siguiendo los lineamientos de la guía metodológica del Ministerio de Salud y Protección Social para recolectar de forma sistemática la evidencia científica y formular las recomendaciones utilizando la metodología GRADE. El presente documento muestra, de forma resumida, el resultado de ese proceso, incluyendo las recomendaciones y las consideraciones tenidas en cuenta para llegar a ellas. En términos generales, se propone un proceso de tamización mediante el cuestionario FINDRISC adaptado a población Colombiana que permite llegar a un diagnóstico temprano de la enfermedad y un algoritmo para el manejo inicial que es generalizable a la gran mayoría de los pacientes con diabetes mellitus tipo 2 y que es sencillo de aplicar en atención primaria. También se hacen unas recomendaciones para escalar el tratamiento farmacológico de los pacientes que no alcanzan la meta o la pierden con el manejo inicial, teniendo en cuenta principalmente la evolución del peso y la individualización de la meta de control glucémico en poblaciones especiales. Finalmente se proponen algunas recomendaciones para la detección oportuna de las complicaciones micro y macrovasculares de la diabetes.

Efficacy of cryotherapy for the treatment of cutaneous leishmaniasis: meta-analyses of clinical trials.

BACKGROUND: Cryotherapy is a local treatment for cutaneous leishmaniasis with variable efficacy and greater safety than conventional treatment. The objective of this study is to evaluate the efficacy and safety of cryotherapy for the treatment of cutaneous leishmaniasis and to compare it with pentavalent antimonials. METHODS: A meta-analysis based on a search of nine databases with eight strategies was conducted. Inclusion and exclusion criteria were applied, the methodological quality of each article was evaluated, and the reproducibility of the study selection and information extraction from each clinical trial was assured. The per lesion and per patient efficacy was calculated, and a meta-analysis of relative risks with the random effects model and the Dersimonian and Laird's, Begg, and Egger tests, along with a sensitivity analysis, were performed. A meta-regression based on the methodological quality of the trials included was also performed. RESULTS: Eight studies were included in which respective per lesion efficacies of 67.3 % and 67.7 % were reported for cryotherapy and pentavalent antimonials. In 271 patients treated with cryotherapy and in 199 with pentavalent antimonials, respective per protocol and intent to treat efficacies of 63.6 % and 54.2 % were found in the first group, and per protocol and intent to treat efficacies of 74.7 % and 68.3 % were found in the second group. The relative risk for the comparison of efficacy in the two groups was 0.73 (0.42-1.29). The results of the sensitivity analysis and the meta-regression analysis of relative risks were statistically equal to the overall results. CONCLUSION: This investigation provides evidence in favor of the use of cryotherapy given that its efficacy is similar to that of pentavalent antimonials.

Clinical practice guideline for the prevention, early detection, diagnosis, management and follow up of type 2 diabetes mellitus in adults / Guía de práctica clínica para la prevención, diagnóstico, tratamiento y seguimiento de la diabetes mellitus tipo 2 en la población mayor de 18 años

In Colombia, diabetes mellitus is a public health program for those responsible for creating and implementing strategies for prevention, diagnosis, treatment, and follow-up that are applicable at all care levels, with the objective of establishing early and sustained control of diabetes. A clinical practice guide has been developed following the broad outline of the methodological guide from the Ministry of Health and Social Welfare, with the aim of systematically gathering scientific evidence and formulating recommendations using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. The current document presents in summary form the results of this process, including the recommendations and the considerations taken into account in formulating them. In general terms, what is proposed here is a screening process using the Finnish Diabetes Risk Score questionnaire adapted to the Colombian population, which enables early diagnosis of the illness, and an algorithm for determining initial treatment that can be generalized to most patients with diabetes mellitus type 2 and that is simple to apply in a primary care context. In addition, several recommendations have been made to scale up pharmacological treatment in those patients that do not achieve the objectives or fail to maintain them during initial treatment. These recommendations also take into account the evolution of weight and the individualization of glycemic control goals for special populations. Finally, recommendations have been made for opportune detection of micro- and macrovascular complications of diabetes.

En Colombia la Diabetes Mellitus es un problema de salud pública por lo que deben generarse e implementarse estrategias de prevención, diagnóstico, tratamiento y seguimiento, aplicables en todos los niveles de atención con miras a establecer el control de la diabetes en forma temprana y sostenida. Se elaboró una guía de práctica clínica siguiendo los lineamientos de la guía metodológica del Ministerio de Salud y Protección Social para recolectar de forma sistemática la evidencia científica y formular las recomendaciones utilizando la metodología GRADE. El presente documento muestra, de forma resumida, el resultado de ese proceso, incluyendo las recomendaciones y las consideraciones tenidas en cuenta para llegar a ellas. En términos generales, se propone un proceso de tamización mediante el cuestionario FINDRISC adaptado a población Colombiana que permite llegar a un diagnóstico temprano de la enfermedad y un algoritmo para el manejo inicial que es generalizable a la gran mayoría de los pacientes con diabetes mellitus tipo 2 y que es sencillo de aplicar en atención primaria. También se hacen unas recomendaciones para escalar el tratamiento farmacológico de los pacientes que no alcanzan la meta o la pierden con el manejo inicial, teniendo en cuenta principalmente la evolución del peso y la individualización de la meta de control glucémico en poblaciones especiales. Finalmente se proponen algunas recomendaciones para la detección oportuna de las complicaciones micro y macrovasculares de la diabetes.

Efficacy of thermotherapy to treat cutaneous leishmaniasis: a meta-analysis of controlled clinical trials.

INTRODUCTION: The efficacy of thermotherapy for the treatment of cutaneous leishmaniasis presents diverse results with low statistical power. OBJECTIVE: To evaluate the efficacy of thermotherapy to treat cutaneous leishmaniasis. METHODS: A meta-analysis of controlled clinical trials in 12 databases based on the implementation of a research protocol with inclusion and exclusion criteria and an assessment of methodological quality. The reproducibility and completeness were guaranteed in the information search and extraction. Heterogeneity, sensitivity and publication bias were assessed by graphical methods (Galbraith, L'Abblé, funnel plot, Egger plot, and influence plot) and analytical methods (DerSimonian-Laird, Begg and Egger). Random-effects forest plots were constructed, and a cumulative meta-analysis was performed. RESULTS: Eight studies were included with 622 patients who underwent thermotherapy, with an efficacy of 73.2% (95% confidence interval (CI) = 69.6-76.7%), and with 667 patients who underwent systemic treatment, with an efficacy of 70.6% (95% CI=67.1-74.1%). Heterogeneity between studies, good sensitivity for the combined measure, and no publication bias were observed. The relative risk for comparison of the efficacy of treatment was 1.02 (95%CI=0.91, 1.15), showing that the effectiveness of thermotherapy is equal to that of pentavalent antimonial drugs. CONCLUSION: Due to its efficacy, greater safety and lower cost, thermotherapy should be the first treatment option for cutaneous leishmaniasis in areas where the prevalence of the mucocutaneous form is low and in patients with contraindications to systemic treatment, such as kidney, liver and heart diseases, as well as in pregnant women, infants, and patients with human immunodeficiency virus infection/acquired immune deficiency syndrome.