Validity and reliability of simple surrogate indexes to evaluate beta-cell function and insulin sensitivity

BACKGROUND: Simple surrogate indexes (SSI) to assess beta-cell function, insulin sensitivity (IS) and insulin resistance (IR) are an easy and economic tool used in clinical practice to identify glucose metabolism disturbances. AIM: To evaluate the validity and reliability of SSI that estimate beta-cell function, IS and IR using as a reference the parameters obtained from the frequently sampled intravenous glucose tolerance test (FSIVGTT). MATERIAL AND METHODS: We included 62 subjects aged 20-45 years, with a normal body mass index and without diabetes or prediabetes. SSI were compared with the acute insulin response to glucose (AIRg), insulin sensitivity index (Si) and disposition index (DI) obtained from the FSIVGTT using the minimal model approach. Half of the participants (n = 31) were randomly selected for a second visit two weeks later to evaluate the reliability of all the variables. RESULTS: HOMA1-%B and HOMA2-%B had a significant correlation with AIRg (Spearman Rho (rs) = 0.33 and 0.37 respectively, p 0.50) with Si were fasting insulin, HOMA1-IR, HOMA2-IR, HOMA1-%S, HOMA2-%S, QUICKI, and the McAuley index. The parameters that showed good reliability with an intraclass correlation coefficient (ICC) > 0.75 were AIRg, HOMA1-%S, HOMA2-%S, and QUICKI. Conclusions: Our results suggest that most of the SSI are useful and reliable.

ANTECEDENTES: Los índices simples subrogados (ISS) que evalúan la función de célula beta, sensibilidad a la insulina (SI) y resistencia a la insulina (RI) son herramientas sencillas y económicas que se usan en la práctica clínica para identificar alteraciones del metabolismo de la glucosa. OBJETIVO: Evaluar la validez y confiabilidad de ISS para estimar la función de célula beta, SI y RI usando como referencia los parámetros de la prueba de tolerancia a la glucosa intravenosa con muestreo frecuente (FSIVGTT). MATERIAL Y MÉTODOS: Se incluyeron 62 sujetos de 20-45 años, con índice de masa corporal normal y sin diabetes mellitus o prediabetes. Los ISS se compararon con la respuesta aguda de la insulina a la glucosa (AIRg), índice de sensibilidad a la insulina (Si) e índice de disposición (DI) obtenidos de la FSIVGTT en base al modelo mínimo. La mitad de los participantes (n = 31) se seleccionaron aleatoriamente para acudir dos semanas después y evaluar la confiabilidad de todas las variables. RESULTADOS: HOMA1-%B y HOMA2-%B presentaron una correlación significativa con AIRg (Rho de Spearman (rs) = 0,33 and 0,37, respectivamente, p 0,50) con Si fueron insulina en ayuno, HOMA1-IR, HOMA2-IR, HOMA1-%S, HOMA2-%S, QUICKI y el índice de McAuley. Los parámetros que tuvieron buena confiabilidad (coeficiente de correlación intraclase > 0,75) fueron AIRg, HOMA1-%S, HOMA2-%S y QUICKI. Conclusiones: La mayoría de los ISS son instrumentos útiles y confiables.

Identification of Glucose and Insulin Patterns during A 5-H Glucose Tolerance Test and Association with Cardiometabolic Risk Factors

ABSTRACT Background: Insulin resistance is key in the pathogenesis of the metabolic syndrome and cardiovascular disease. Objective: We aimed to identify glucose and insulin patterns after a 5-h oral glucose tolerance test (OGTT) in individuals without diabetes and to explore cardiometabolic risk factors, beta-cell function, and insulin sensitivity in each pattern. Methods: We analyzed the 5-h OGTT in a tertiary healthcare center. We identified classes using latent class trajectory analysis and evaluated their association with cardiometabolic risk factors, beta-cell function, and insulin sensitivity surrogates by multinomial logistic regression analysis. Results: We included 1088 5-h OGTT performed between 2013 and 2020 and identified four classes. Class one was associated with normal insulin sensitivity and secretion. Class two showed hyperglycemia, dysinsulinism, and a high-risk cardiometabolic profile (obesity, hypertriglyceridemia, and low high-density lipoprotein [HDL] cholesterol). Class three included older individuals, a higher proportion of males, and a greater prevalence of hypertension, hyperglycemia, hyperinsulinemia, and postprandial hypoglycemia. Finally, class four showed hyperglycemia, dysinsulinism, and hyperinsulinemia; this class had the worst cardiometabolic profile (a high proportion of males, greater age, hypertension, obesity, hypertriglyceridemia, and low HDL cholesterol, p < 0.001 vs. other classes). Conclusions: The latent class analysis approach allows the identification of groups with an adverse cardiometabolic risk factor, and who might benefit from frequent follow-ups and timely multidisciplinary interventions.

Guía de práctica clínica mexicana para el diagnóstico y tratamiento de las dislipidemias y enfermedad cardiovascular aterosclerótica / Mexican clinical practice guideline for the diagnosis and treatment of dyslipidemias and atherosclerotic cardiovascular disease

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Abstract Background: Cardiovascular diseases are the leading cause of mortality worldwide and Mexico is no exception. The epidemiological data obtained in 1990 showed that cardiovascular diseases represented 19.8% of all causes of death in our country. This figure increased significantly to 25.5% for 2015. Some national surveys suggest that more than 60% of the adult population has at least one risk factor for cardiovascular disease (obesity or overweight, hypertension, smoking, diabetes, dyslipidemias). On the other hand, data from the Pan American Health Organization have linked the process of atherosclerosis as the first cause of premature death, significantly reducing life expectancy, which has enormous social repercussions. Objective: This document constitutes the Clinical Practice Guide (CPG) prepared at the initiative of the Mexican Society of Cardiology in collaboration with the Mexican Society of Nutrition and Endocrinology, AC, National Association of Cardiologists of Mexico, AC, Mexican Association for the Prevention of Atherosclerosis and its Complications, AC, National Normative Committee of General Medicine, AC, National College of Geriatric Medicine, AC, College of Internal Medicine of Mexico, AC, Mexican Society of Angiology and Vascular and Endovenous Surgery, AC, Mexican Institute of Research Nephrological, AC and the Mexican Academy of Neurology, A.C.; with the methodological support of the Ibero-American Agency for the Development and Evaluation of Health Technologies, in order to establish recommendations based on the best available evidence and agreed upon by an interdisciplinary group of experts. The objective of this document is to provide evidence-based recommendations to help decision makers in the diagnosis and treatment of dyslipidemias in our country. Material and methods: This document complies with international quality standards, such as those described by the Institute of Medicine of the USA, the Institute of Clinical Excellence of Great Britain, the Scottish Intercollegiate Guideline Network and the Guidelines International Network. A multidisciplinary group of clinical experts and methodologists with experience in systematic reviews of the literature and the development of clinical practice guidelines was formed. A scope document was agreed upon, relevant clinical questions were established, the best available evidence critically evaluated in systematic literature reviews was exhaustively identified, and clinical recommendations were developed. The modified Delphi Panel methodology was used to achieve an adequate level of consensus in each of the recommendations contained in this CPG. Results: 23 clinical questions were agreed upon which gave rise to their respective clinical recommendations. Conclusions: We consider that this document contributes to better clinical decision-making and becomes a point of reference for clinicians and patients in the management of dyslipidemias and this contributes to reducing the morbidity and mortality derived from atherosclerotic cardiovascular events in our country.

Trends in the prevalence of metabolic syndrome and its components in Mexican adults, 2006-2018 / Tendencia en la prevalencia de síndrome metabólico y sus componentes en adultos mexicanos, 2006-2018

Abstract: Objective: To examine trends in the prevalence of metabolic syndrome (MS) and its components. Materials and methods: Data from 27 800 Mexican adults who participated in Ensanut 2006, 2012, 2016 and 2018 were analyzed. Linear regression was used across each Ensanut period to assess temporal linear trends in the prevalence of MS. Logistic regression models were obtained to calculate the percentage change, p-value for the trend and the association between the presence of MS and the risk of developing type 2 diabetes mellitus (T2DM) over 10 years using the Finnish Diabetes Risk Score (FINDRISC) and cardiovascular disease (CVD) using Globorisk. Results: The prevalence of MS in Mexican adults according to the harmonized definition was: 40.2, 57.3, 59.99 and 56.31%, in 2006, 2012, 2016 and 2018 respectively (p for trend <0.0001). In 2018, 7.62% of metabolic syndrome cases had a significant risk for incident DM2 and 11.6% for CVD. Conclusion: It is estimated that there are 36.5 million Mexican adults living with metabolic syndrome, of which 2 million and 2.5 million have a high risk of developing T2DM or cardiovascular disease respectively, over the next 10 years.

Resumen: Objetivo: Examinar las tendencias en la prevalencia del síndrome metabólico (SM) y de sus componentes. Material y métodos: Se analizaron datos de 27 800 adultos mexicanos que participaron en las Ensanut 2006, 2012, 2016 y 2018. Se utilizó regresión lineal en cada periodo de Ensanut para evaluar las tendencias lineales temporales en la prevalencia del SM. Se obtuvieron modelos de regresión logística para calcular el cambio porcentual, P para la tendencia y las asociaciones entre la SM con el riesgo de desarrollar en 10 años diabetes mellitus tipo 2 utilizando la Finnish Diabetes Risk Score (FINDRISC) y enfermedad cardiovascular utilizando Globorisk. Resultados: La prevalencia de SM en adultos mexicanos según la definición armonizada fue: 40.2, 57.3, 59.99 y 56.31%, en 2006, 2012, 2016 y 2018 respectivamente (p para tendencia <0.0001). En 2018, 7.62% de los casos de síndrome metabólico tenían un riesgo significativo de DM2 incidente y 11.6% de ECV. Conclusión: Se estima que los adultos mexicanos con síndrome metabólico son 36.5 millones; de ellos, dos millones tienen un alto riesgo de desarrollar DMT2 en los próximos 10 años y 2.5 millones enfermedades cardiovasculares.

Prevalence of diabetes and glycemic control in Mexico: national results from 2018 and 2020 / Prevalencia de diabetes y control glucémico en México: resultados nacionales 2018 y 2020

Abstract: Objective: To estimate the prevalence of diabetes (diagnosed and undiagnosed), glycemic control in Mexico, and its associated factors. Materials and methods: We used data from Ensanut 2018 (n=12 648) and 2020 (n=2 309). We defined diabetes as fasting glucose ≥126 mg/dl or HbA1c≥6.5% or previously diagnosed; glycemic control was defined as HbA1c<7%. We fitted Poisson regression models to assess the association between diabetes, glycemic control, and potential associated factors. Results: The total prevalence of diabetes was 16.8% in 2018 and 15.7% in 2020. In 2018, 38% of adults with diabetes were unaware of their disease, while in 2020 this figure was 29%. Glycemic control was observed in 42% of participants in 2018 and 39% in 2020. Longer disease duration was associated with lower glycemic control, while older age, having a diet, and being affiliated to IMSS, Pemex, Sedena, or private healthcare were associated with better control. Conclusion: Mexico is among the countries with the highest diabetes prevalence. A high proportion of adults with diabetes did not have a previous diagnosis, and the proportion with glycemic control is low. Strengthening screening to achieve a timely diagnosis, and improving glycemic control, should be key actions in the management of diabetes.

Resumen: Objetivo: Estimar la prevalencia de diabetes total (diagnosticada y no diagnosticada), control glucémico en México y sus factores asociados. Material y métodos: Se analizó información de la Ensanut 2018 (n=12 648) y 2020 (n=2 309). Se definió diabetes como glucosa en ayunas ≥126 mg/dl o HbA1c≥6.5% o diagnóstico previo; se consideró control glucémico si HbA1c<7%. Usando modelos de regresión de Poisson, se estimaron los factores asociados con diabetes y control glucémico. Resultados: La prevalencia de diabetes fue de 16.8% en 2018 y 15.7% en 2020. En 2018, 38% de los adultos con diabetes desconocían su enfermedad, en 2020 fue 29%. El control glucémico se observó en 42% de los participantes en 2018 y en 39% en 2020. Mayor tiempo de diagnóstico se asoció con descontrol glucémico mientras que mayor edad, seguir una dieta y estar afiliado al IMSS, Pemex/Sedena o privados se asoció con control glucémico. Conclusión: México se encuentra entre los países con mayor prevalencia de diabetes. Una alta proporción de adultos con diabetes no tenía un diagnóstico previo y la proporción con control glucémico es baja. Fortalecer la detección, el diagnóstico oportuno y el control glucémico es clave para el manejo de la diabetes.

Bioethics in medical care rationing during the coronavirus disease-19 pandemic

ABSTRACT Background: Coronavirus (CoV) disease (COVID)-19 poses difficult situations in which the ethical course of action is not clear, or choices are made between equally unacceptable responses. Methods: A web search was performed using the terms “bioethics; COVID-19; ethics; severe acute respiratory syndrome CoV-2; emergent care; pandemic; and public health emergencies.” Results: Protection from COVID-19 has resulted in the cancellation of necessary medical interventions, lengthened suffering, and potential non-COVID-19 deaths. Prolonged lockdown reduced well-being, triggering or aggravating mental illnesses and violence, and escalated medical risks. Collateral damage includes restrictions on visitations to hospitals, alienation from the deceased relative, or lack of warm caring of patients. Finally, in a public health crisis, public health interest overrides individual rights if it results in severe harm to the community. Conclusion: Balancing ethical dilemmas are one more challenge in the COVID-19 pandemic. (REV INVEST CLIN. 2021;73(1):1-5)

Bioethics in the COVID-19 Pandemic Research: Challenges and Strategies

As all other aspects in times of the coronavirus disease (COVID)-19 pandemic, carrying-out quality clinical research has been challenging. Many well-established paradigms have shifted as a consequence of the rapid demand for new knowledge. New treatments are fast-moving, informed consent forms are difficult to obtain, a competitive invitation from researchers to participate in different studies is common, and non-COVID-19 research protocols are suffering continuity. However, these challenges should not imply taking shortcuts or accepting deficiencies in bioethical standards, but rather enhance the alertness for rigorous ethical approaches despite these less than ideal circumstances. In this manuscript, we point out some interrogates in COVID-19 research and outline possible strategies to overcome the difficult task to continue with high-quality research without violating the ethical principles. (REV INVEST CLIN. 2020;72(5):265-70)

Submuestra para el análisis de enfermedades crónicas con biomarcadores, Encuesta Nacional de Salud y Nutrición 2016 / Subsample for the analysis of chronic diseases with biomarkers, National Survey of Health and Nutrition 2016

Resumen Objetivo: Describir la submuestra de adultos para el análisis de biomarcadores de enfermedades crónicas, así como los tamaños de muestra (n) y la representatividad de las mismas en la Encuesta Nacional de Salud y Nutrición 2016. Material y métodos: Se calculó una submuestra con representatividad nacional para la obtención de sangre, suero y orina en adultos. Se comparó la prevalencia de variables de interés para las submuestras. Resultados: Las n obtenidas de suero y orina fueron de 4 000 y 3 782 adultos con al menos un valor en algún marcador bioquímico sérico y marcadores de orina, respectivamente. Esta n varió con el agrupamiento de marcadores y selección por horas de ayuno. No se observaron diferencias en la distribución de las variables de interés entre las muestras de hogar, sangre y orina. Conclusión: Los datos ponderados de las submuestras de marcadores en orina, suero y sangre son comparables con la muestra total de adultos de la encuesta. Los datos de las submuestras permitirán monitorear la distribución de enfermedades crónicas en México, incluidas las alteraciones en función hepática, renal, y consumo de sodio.

Abstract Objective: To describe the adult subsample for the analysis of biomarkers of chronic diseases, as well as the sample sizes (n) and representativity of the Encuesta Nacional de Salud y Nutrición (Ensanut) 2016. Materials and methods: An adult subsample with national representativity was calculated to obtain blood, serum and urine samples. The prevalence of variables of interest was compared for each subsample. Results: The n for at least one serum biomarker and urine samples were 4 000 and 3 782, respectively. The n varied depending on the grouping of biomarkers and fasting time selection. No differences were observed in the distribution of variables between the whole sample, urine and blood biomarkers samples. Conclusion: The weighted subsamples of urine, serum and blood biomarkers are comparable to the weighted sample of adults in the survey. The data of the subsample will allow to monitor the distribution of chronic diseases in Mexico, including altered function of liver and kidney, and sodium intake.

Universal masking during covid-19 pandemic - current evidence and controversies

ABSTRACT The emergence of coronavirus disease 19 pandemic and novel research on the high transmissibility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has raised controversies over the use of face masks to prevent community transmission. Specific regulations need to be fulfilled to use a face mask as part of the personal protective equipment and high quality of evidence supporting its use to prevent respiratory viral infections, including SARS-CoV-2, is lacking. However, its widespread use is becoming a standard practice in some countries and discrepancies between health authorities on their policy have led to controversy. The aim of this review is to provide an outlook on recent research in this matter and areas of opportunity.

Dyslipidemia prevalence, awareness, treatment and control in Mexico: results of the Ensanut 2012 / Prevalencia de dislipidemias, diagnóstico previo, tratamiento y control: resultados de la Ensanut 2012

Abstract: Objective: To describe in a national sample 1) the prevalence, awareness, treatment and control of dyslipidemias 2) the prevalence of dyslipidemias through previous national surveys. Materials and methods: We analyzed data of the National Health and Nutrition Survey 2012, a representative cross-sectional study. Serum samples of 9 566 adults ≥20 years old with fasting ≥8 hours were analyzed for lipid fractions. Age-adjusted prevalences were calculated, by sociodemographic variables. Prevalence of awareness, treatment and control was estimated. A description of the dyslipidemia prevalence reported in previous surveys is reported. Results: Hypoalphalipoproteinemia and elevated LDL-C are the most prevalent dyslipidemias in Mexican adults. One in four adults had hypercholesterolemia at the moment of the interview without previous diagnosis. Awareness, treatment and control of dyslipidemia were 12.6, 3.7 and 3.1%, respectively. Conclusions: Dyslipidemias are the most prevalent risk factor for cardiovascular diseases in Mexico. Public policies to increase awareness, access to therapy and sustained control are urgently needed.

Resumen: Objetivo: Describir en una muestra nacional 1) la prevalencia de dislipidemias, su diagnóstico previo, tratamiento y control, y 2) la prevalencia de dislipidemias en las encuestas previas. Material y métodos: Se analizaron datos de la Encuesta Nacional de Salud y Nutrición 2012 con representatividad nacional. Se analizaron fracciones de lípidos séricos de 9 566 adultos ≥20 años con ayuno ≥8 horas. Se estimaron las prevalencias de dislipidemias, diagnóstico previo (DP), tratamiento y control, ajustadas por edad. Se presenta un análisis comparativo de las prevalencias de dislipidemias reportadas previamente. Resultados: Las dislipidemias más prevalentes en adultos mexicanos fueron hipoalfalipoproteinemia y LDL-C elevado. Uno de cada cuatro adultos tenía hipercolesterolemia al momento de la entrevista, sin DP. El DP, tratamiento y control de dislipidemias fue de 12.6, 3.7 y 3.1%, respectivamente. Conclusiones: Las dislipidemias son el factor de riesgo para enfermedades cardiovasculares más prevalente en adultos mexicanos. Se necesitan políticas públicas para incrementar el diagnóstico, acceso a terapia y control.

Prevalencia de diabetes y descontrol glucémico en México: resultados de la Ensanut 2016 / Prevalence of diabetes and poor glycemic control in Mexico: results from Ensanut 2016

Resumen: Objetivo: Estimar la prevalencia de diabetes (total, diagnosticada y no diagnosticada), de descontrol glucémico en México y sus factores asociados. Material y métodos: Se analizaron 3 700 adultos participantes en la Encuesta Nacional de Salud y Nutrición de 2016. Se estimaron las prevalencias con ponderadores poblacionales y los factores asociados con diabetes total y descontrol glucémico con modelos de regresión de Poisson. Resultados: La prevalencia total de diabetes fue de 13.7% (9.5% diagnosticada, 4.1% no diagnosticada); 68.2% de los diagnosticados presentó descontrol glucémico. Mayor tiempo de diagnóstico, vivir en el centro/sur del país y ser atendido en farmacias se asoció con descontrol glucémico, mientras que ser atendido en los servicios de seguridad social se asoció con mejor control glucémico. Conclusión: Se requieren esfuerzos multisectoriales para fortalecer el tamizaje, diagnóstico oportuno y control de la enfermedad, considerando las diferencias por región y tipo de servicio de salud.

Abstract: Objective: To estimate the prevalence of total, diagnosed and undiagnosed diabetes, and the prevalence of poor glycemic control in Mexico, and its associated factors. Materials and methods: Data from 3 700 adult participants were analysed in the 2016 National Health and Nutrition Survey. Diabetes prevalences were estimated with population weights, and the factors associated with total diabetes and poor glycemic control with Poisson regression models. Results: The total prevalence of diabetes was 13.7% (9.5% diagnosed, 4.1% undiagnosed); 68.2% of people with diagnosed diabetes presented poor glycemic control. Longer disease duration, living in the centre or south of the country and being treated in pharmacies were associated with poor glycemic control. Being treated in a social security system was associated with better glycemic control. Conclusion: Multisectoral efforts are needed to strengthen screening, timely diagnosis and disease control, considering differences by region and type of health service.

Perfiles poblacionales asociados con la asistencia a servicios preventivos para tamizaje de diabetes e hipertensión. Ensanut 2018-19 / Population profiles associated with attendance at preventive services to screening tests. Ensanut 2018-19

Resumen: Objetivo: Presentar el perfil de la población de 20 años o más que acude a realizarse una prueba de detección de diabetes y de hipertensión. Material y métodos: Con información de la Encuesta Nacional de Salud y Nutrición 2018-19, se obtuvieron dos modelos de regresión logística múltiple con variables asociadas con la detección de diabetes e hipertensión. Se generaron perfiles basados en combinaciones de las variables incluidas en el modelo. Se graficaron los incrementos de las probabilidades de acuerdo con los perfiles. Resultados: La población cuyas probabilidades predichas son las más altas para acudir a detección corresponde a adultos con antecedente familiar de la enfermedad, con comorbilidad asociada y estilos de vida poco saludables. Conclusiones: El sistema de salud debe buscar personas con el mayor riesgo de desarrollar o tener diabetes e hipertensión sin diagnóstico, mediante cuestionarios de riesgo tipo score. A esta población se les deberán hacer estudios de tamizaje y, en su caso, diagnósticos.

Abstract: Objective: We describe the profile of the population aged 20 years and over, who go for a diabetes and hypertension screening test. Materials and methods: Based on the information from Ensanut 2018-19, two multiple logistic regression models were obtained with variables associated with the detection of diabetes and hypertension. Profiles were generated based on combinations of the variables included in the model. Increases in probabilities were plotted according to profiles. Results: Individuals with a family history of the disease, comorbidities or unhealthy lifestyles composed the group that seek for diabetes and hypertension screening. Conclusions: The health system should look for those with the highest risk of developing or having undiagnosed diabetes and hypertension, using risk questionnaires, type score. This population should undergo screening studies and, where appropriate, diagnoses.

Factors influencing achievement of low-density lipoprotein cholesterol goals in mexico: the international cholesterol management practice study

ABSTRACT Background The International Cholesterol Management Practice Study is a multinational collaborative effort to describe the effectiveness of the lipid-lowering therapy (LLT) as well as the main barriers to achieve the low-density lipoprotein cholesterol (LDL-C) goals Objective The objective of the study was to investigate factors associated with the achievement of LDL-C goals in Mexico using real-life data Methods This was a cross-sectional observational study from 18 physicians across different health facilities in Mexico, who provided information about their practices between August 2015 and August 2016. We included patients treated for ≥3 months with any LLT in whom LDL-C measurement on stable LLT was available for the previous 12 months Results We included 623 patients with a mean age of 59.3 ± 12.7 years; 55.6% were women. The mean LDL-C value on LLT was 141.8 ± 56.1 mg/dL. At enrollment, 97.4% of patients were receiving statin therapy (11.3% on high-intensity treatment). Only 24.8% of the very-high cardiovascular (CV) risk patients versus 26.4% of the high risk and 52.4% of the moderate risk patients achieved their LDL-C goals. Independent factors associated with non-achievement of LDL-C goal were statin intolerance, overweight and obesity, abdominal obesity, female sex, high CV risk, use of public health-care service, metabolic syndrome, type 2 diabetes, and hypertriglyceridemia. Higher-level of education was associated with a lower risk of not achieving LDL-C goals Conclusions Achievement of LDL-C goals is suboptimal in Mexico, especially in patients with the highest CV risk. The main barriers to achieve the goal are easily detectable. Implementation of LLT should be adapted to the patient’s needs and profile.

Atención médica y acciones de autocuidado en personas que viven con diabetes, según nivel socioeconómico / Medical care and self-care actions in people living with diabetes, according to socioeconomic level

Resumen: Objetivo: Caracterizar la atención médica y las acciones de autocuidado en población con diabetes, en localidades de menos de 100 000 habitantes. Material y métodos: Con información de la Encuesta Nacional de Salud y Nutrición 100k (Ensanut 100k), se obtuvieron dos modelos de regresión logística: no realizar las cinco acciones básicas en la última consulta médica y no realizar acciones prioritarias de autocuidado. Resultados: Tener baja escolaridad, pertenecer al estrato económico bajo y hablar lengua indígena incrementan las posibilidades de no realizar acciones de autocuidado. Por el contrario, al incrementarse la edad, se disminuyen las posibilidades de autocuidado en 3%. Pertenecer a un hogar indígena y al tercil bajo incrementan las posibilidades de que el personal de salud no realice las cinco acciones básicas durante la consulta. Conclusión: Es indispensable que se establezca un programa de control de diabetes que incluya educación a pacientes y cursos de actualización al personal médico.

Abstract: Objective: To characterize medical care and self-care actions in a population with diabetes in locations smaller than 100 000 inhabitants Materials and methods: With information from the Encuesta Nacional de Salud y Nutrición 100k (Ensanut 100k), two logistic regression models were obtained: not performing five basic actions in the last consultation and not taking priority self-care actions. Results: Having low schooling, belonging to the low economic stratum, and speaking indigenous language, increase the probability of not taking self-care actions. On the contrary, as age increases, the chances of self-care are reduced by 3%. Belonging to an indigenous household and the low tercile, increases the chances that health personnel will not perform the five basic actions during the consultation. Conclusions: It is essential that a diabetes control program be established that includes patient education and update courses for medical staff

III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects’ first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.

II. The research ethics involving vulnerable groups

Abstract Vulnerability in research occurs when the participant is incapable of protecting his or her interests and therefore, has an increased probability of being intentionally or unintentionally harmed. This manuscript aims to discuss the conditions that make a group vulnerable and the tools and requirements that can be used to reduce the ethical breaches when including them in research protocols. The vulnerability can be due either to an inability to understand and give informed consent or to unequal power relationships that hinder basic rights. Excluding subjects from research for the only reason of belonging to a vulnerable group is unethical and will bias the results of the investigation. To consider a subject or group as vulnerable depends on the context, and the investigator should evaluate each case individually.

I. The role of research ethics committees in observational studies: epidemiological registries, case reports, interviews, and retrospective studies

Abstract It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.

Diseño y validación de un score para detectar adultos con prediabetes y diabetes no diagnosticada / Development and validation of a screening score for prediabetes and undiagnosed diabetes

Resumen: Objetivo: Diseñar y validar un score de riesgo de fácil aplicación para detectar prediabetes y diabetes no diagnosticada en población mexicana. Material y métodos: Empleando la información del estudio de cohorte de 10 234 adultos del Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), se identificaron factores de riesgo incluidos en modelos de regresión logística múltiple estratificados por sexo. Los coeficientes beta fueron multiplicados por 10 para obtener el peso de cada variable en el score. Una submuestra de la Encuesta Nacional de Salud y Nutrición (Ensanut) 2012 se usó para validar el score. Resultados: El score propuesto clasificó correctamente 55.4% a las mujeres con diabetes no diagnosticada y 57.2% a las mujeres con prediabetes o diabetes. Por su parte, clasificó correctamente a los hombres en 68.6 y 69.9%, respectivamente. Conclusiones: Presentamos el diseño y validación de un score de riesgo estratificado por sexo para determinar si un adulto podría tener prediabetes o diabetes, en cuyo caso deberán realizarse estudios de laboratorio para confirmar o descartar el diagnóstico.

Abstract: Objective: To develop and validate an easy-to-use risk score to detect prediabetes and undiagnosed diabetes in Mexican population. Materials and methods: Using information from the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán's cohort study of 10 234 adults, risk factors were identified and included in multiple logistic regression models stratified by sex. The beta coefficients of the final model were multiplied by 10, thus obtaining the weights of each variable in the score. Results: The proposed score correctly classifies 55.4% of women with undiagnosed diabetes and 57.2% of women with prediabetes or diabetes. While for men it correctly classifies them at 68.6% and 69.9%, respectively. Conclusions: We present the design and validation of a risk score stratified by sex, to determine if an adult could have prediabetes or diabetes, in which case laboratory studies should be performed to confirm or not the diagnosis.

Prevalencia de diabetes por diagnóstico médico previo en México / Prevalence of previously diagnosed diabetes mellitus in Mexico

Resumen: Objetivo: Comparar la prevalencia de diabetes por diagnóstico médico previo en 2016 con encuestas nacionales anteriores y describir su tratamiento y complicaciones. Material y métodos: Se utilizaron la Encuesta Nacional de Salud 2000, las Encuestas Nacionales de Salud y Nutrición 2006 y 20012, y la Encuesta Nacional de Salud y Nutrición de Medio Camino 2016. Para 2016 se obtuvieron modelos de regresión logística, así como medidas de tendencia central y dispersión. Resultados: La prevalencia de diabetes por diagnóstico médico en 2016 fue de 9.4%. El incremento de 2.2% respecto a 2012 no fue significativo y se observó únicamente en los mayores de 60 años. Aunque las acciones preventivas han aumentado, el acceso al tratamiento médico y los estilos de vida no han mejorado. Se observó un aumento en insulina y una diminución en hipoglucemiantes. Conclusión: El envejecimiento de la población, la insuficiencia de acciones de tamizaje y el aumento en las complicaciones de diabetes provocarán un aumento en la carga de enfermedad. Invertir en la prevención primaria y secundaria en diabetes es crucial.

Abstract: Objective: To compare the prevalence of previously diagnosed diabetes in 2016 with previous national surveys and to describe treatment and its complications. Materials and methods: Mexico's national surveys Ensa 2000, Ensanut 2006, 2012 and 2016 were used. For 2016, logistic regression models and measures of central tendency and dispersion were obtained. Results: The prevalence of previously diagnosed diabetes in 2016 was 9.4%. The increase of 2.2% relative to 2012 was not significant and only observed in patients older than 60 years. While preventive measures have increased, the access to medical treatment and lifestyle has not changed. The treatment has been modified, with an increase in insulin and decrease in hypoglycaemic agents. Conclusions: Population aging, lack of screening actions and the increase in diabetes complications will lead to an increase on the burden of disease. Policy measures targeting primary and secondary prevention of diabetes are crucial.