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2.
Rev Panam Salud Publica ; 47: e114, 2023.
Artigo em Espanhol | MEDLINE | ID: mdl-37564920

RESUMO

Objective: To assess the occupational factors associated with the occurrence of COVID-19 in health personnel who were exposed to different magnitudes of risk and who followed the United Nations crisis management policy for COVID-19. Methods: Cross-sectional survey conducted between April and May 2021. The low-risk group (LRG) were considered to be those who had minimal contact with patients; the medium-risk group (MRG) had contact with non-COVID-19 patients and did not perform instrumental airway intervention; and the high-risk group (HRG) were those who cared for COVID-19 patients and performed instrumental intervention with aerosol generation. Diagnosed COVID-19 disease and the presence of positive IgG antibodies for SARS-CoV-2 measured with Elecsys® anti-SARS-CoV-2 were considered as outcomes. Results: Outcome recorded in 43.8% of the LRG, versus 46.7% in the MRG (odds ratio [OR]: 1.125; 95% confidence interval [CI 95% ]: 0.896-1.414; p = 0.311), and 48.6% in the HRG (OR: 1,214; CI 95%: 0.964-1.530; p= 0.10). Conclusion: Belonging to the high-risk group and the medium-risk group, based on the degree of exposure to confirmed COVID-19 patients in the work area, was not associated with a higher occurrence of disease or seroconversion.


Objetivo: Avaliar os fatores ocupacionais associados à ocorrência de COVID-19 em profissionais de saúde expostos a diferentes níveis de risco utilizando a política de gestão de crises elaborada pelas Nações Unidas para a COVID-19. Métodos: Pesquisa transversal realizada entre abril e maio de 2021. O grupo de risco baixo (GRB) consistia em profissionais que tinham contato mínimo com os pacientes; o grupo de risco médio (GRM) incluía profissionais que tinham contato com pacientes sem COVID-19 e não realizavam intervenções instrumentais nas vias aéreas; e grupo de risco alto (GRA), profissionais que cuidavam de pacientes com COVID-19 e realizavam intervenções instrumentais com geração de aerossóis. Para estabelecer o desfecho, considerou-se a história de COVID-19 do profissional de saúde e a detecção de anticorpos IgG anti- SARS-CoV-2 por Elecsys® Anti-SARS-CoV-2. Resultados: A doença foi diagnosticada em 43,8% dos profissionais no GRB, 46,7% no GRM (razão de chances ajustada: 1,125; intervalo de confiança de 95% [IC95%]: 0,896-1,414; p = 0,311) e 48,6% no GRA (razão de chances: 1,214; IC95%: 0,964-1,530; p = 0,10). Conclusões: Pertencer ao GRM e ao GRA em função do nível de exposição a pacientes confirmados com COVID-19 no ambiente de trabalho não foi associado a um aumento da ocorrência da doença ou da soroconversão.

3.
Gut ; 71(2): 254-264, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-33597157

RESUMO

OBJECTIVE: Hydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system (Revita DMR (catheter and system)), on glycaemic control and liver fat content in type 2 diabetes (T2D). DESIGN: Eligible patients (haemoglobin A1c (HbA1c) 59-86 mmol/mol, body mass index≥24 and ≤40 kg/m2, fasting insulin >48.6 pmol/L, ≥1 oral antidiabetic medication) enrolled in Europe and Brazil. Primary endpoints were safety, change from baseline in HbA1c at 24 weeks, and liver MRI proton-density fat fraction (MRI-PDFF) at 12 weeks. RESULTS: Overall mITT (DMR n=56; sham n=52), 24 weeks post DMR, median (IQR) HbA1c change was -10.4 (18.6) mmol/mol in DMR group versus -7.1 (16.4) mmol/mol in sham group (p=0.147). In patients with baseline liver MRI-PDFF >5% (DMR n=48; sham n=43), 12-week post-DMR liver-fat change was -5.4 (5.6)% in DMR group versus -2.9 (6.2)% in sham group (p=0.096). Results from prespecified interaction testing and clinical parameter assessment showed heterogeneity between European (DMR n=39; sham n=37) and Brazilian (DMR n=17; sham n=16) populations (p=0.063); therefore, results were stratified by region. In European mITT, 24 weeks post DMR, median (IQR) HbA1c change was -6.6 mmol/mol (17.5 mmol/mol) versus -3.3 mmol/mol (10.9 mmol/mol) post-sham (p=0.033); 12-week post-DMR liver-fat change was -5.4% (6.1%) versus -2.2% (4.3%) post-sham (p=0.035). Brazilian mITT results trended towards DMR benefit in HbA1c, but not liver fat, in context of a large sham effect. In overall PP, patients with high baseline fasting plasma glucose ((FPG)≥10 mmol/L) had significantly greater reductions in HbA1c post-DMR versus sham (p=0.002). Most adverse events were mild and transient. CONCLUSIONS: DMR is safe and exerts beneficial disease-modifying metabolic effects in T2D with or without non-alcoholic liver disease, particularly in patients with high FPG. TRIAL REGISTRATION NUMBER: NCT02879383.


Assuntos
Ablação por Cateter , Diabetes Mellitus Tipo 2/terapia , Duodeno/cirurgia , Ressecção Endoscópica de Mucosa , Hipertermia Induzida , Mucosa Intestinal/cirurgia , Adulto , Idoso , Diabetes Mellitus Tipo 2/sangue , Método Duplo-Cego , Estudos de Viabilidade , Feminino , Hemoglobinas Glicadas/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
4.
Gac Med Mex ; 158(4): 242-248, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36256563

RESUMO

Current model of medicine has made for medical care, teaching and research to be driven apart, with an impact on the patient: during the process of care, the doctor fails to apply the scientific method, he only treats the ailment without accompanying the patient. The medical researcher looks for answers to questions far removed from patient ailments and, in the best-case scenario, conducts research on patient specimens. In addition, the student-teacher dyad is characterized by the transmission of knowledge and leaves aside understanding of the patient. Patients, doctors, researchers and students are oblivious to decision-making and, without questioning, they merely follow processes. One way to address the problem is to return to the DIA-person Integration Model: "concern and doing for the person, accompanied by the integration of teaching, research and medical care", which would allow the transfer of knowledge, skills and benefits from one activity to others. The model consists of contrasting the patient condition with knowledge, carrying out research during and parallel to the medical care-teaching process, as well as applying the architecture of research model "clinical judgment structured description", as a reference and reflection process that integrates the activities of teaching-research and person-oriented medical care.


El modelo actual de la medicina ha distanciado la atención médica, la docencia y la investigación, con impacto en el paciente: durante la atención, el médico omite aplicar el método científico, solo atiende la dolencia sin acompañar al paciente; el investigador médico busca respuestas a preguntas alejadas de las dolencias del paciente y, en el mejor de los casos, realiza investigación en especímenes provenientes de este; la díada estudiante-profesor se caracteriza por la transmisión de conocimiento y deja de lado la comprensión del paciente. Pacientes, médicos, investigadores y estudiantes son ajenos a la toma de decisiones y sin cuestionamientos solo siguen procesos. Una manera de abordar el problema es regresar al Modelo de Integración DIA-persona: "la preocupación y el hacer por la persona, acompañados por la integración de docencia, investigación y atención médica", lo que permitiría el traslado del conocimiento, destrezas y beneficios de una actividad a otra. El modelo consiste en contrastar la condición del paciente con el conocimiento, realizar investigación durante y en paralelo al proceso de atención-docencia médica, así como aplicar el modelo arquitectónico de la investigación "descripción estructurada del juicio clínico", como proceso de referencia y reflexión que integra las actividades de docencia-investigación y atención médica orientadas a la persona.


Assuntos
Pessoal de Saúde , Estudantes , Humanos , Masculino , Assistência ao Paciente , Pesquisa , Aprendizagem
5.
Gac Med Mex ; 157(4): 428-435, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-35133345

RESUMO

INTRODUCTION: In developing countries, protein-energy malnutrition causes 60% of deaths in children < 5 years of age. OBJECTIVE: To evaluate the effect of a ready-to-use supplementary food (RUSF) on moderate acute malnutrition (MAM) in preschool children. METHOD: Clinical trial that included 155 children with MAM (weight/height Z-score > -3 and ≤ -2). Each child received RUSF in the form of biscuits, four per day (250 kcal), for 12 months. The tutor received education on nutrition, health and hygiene. Recovery (weight/height Z-score > -2) at four, six, and 12 months was assessed using intent-to-treat (ITT) and per protocol (PP) analyses. Changes in chronic malnutrition were also analyzed. RESULTS: In the first semester, adequate RUSF consumption was observed in 61% of the children, and in 42% in the second semester. In the ITT analysis, 78% were identified to have recovered, with 38% reaching normal nutritional values; in the PP analysis, > 90% recovered and > 40% reached normal values. Recovery from chronic malnutrition was also observed. CONCLUSIONS: The consumption of RUSF and an educational program reduced MAM.


INTRODUCCIÓN: En países en desarrollo, la desnutrición proteico-energética causa 60 % de las muertes en los niños menores de cinco años. OBJETIVO: Evaluar el efecto de un suplemento alimenticio listo para consumir (SALC) en la desnutrición aguda moderada (DAM) en niños preescolares. MÉTODO: Ensayo clínico que incluyó 155 niños con DAM (puntuación Z de peso/talla [pZ] mayor de −3 y menor o igual a −2). Cada niño recibió SALC en forma de galletas, cuatro por día (250 kcal), durante 12 meses. El tutor recibió educación sobre nutrición, salud e higiene. La recuperación (pZ peso/talla mayor de −2) a los cuatro, seis y 12 meses se evaluó con un análisis por intención a tratar (AIT) y por protocolo (APP). También se analizaron cambios en la desnutrición crónica. RESULTADOS: En el primer semestre se observó consumo adecuado del SALC en 61 % de los niños y en 42 % en el segundo semestre. Con el AIT se identificó que 78 % se recuperó y 38 % alcanzó valores normales de nutrición; con el APP, > 90 % se recuperó y > 40 % alcanzó valores normales. Se observó recuperación de la desnutrición crónica. CONCLUSIONES: El consumo de SALC y un programa educativo redujeron la DAM.


Assuntos
Desnutrição , Desnutrição Proteico-Calórica , Pré-Escolar , Suplementos Nutricionais , Fast Foods , Alimentos Fortificados , Humanos , Lactente , Desnutrição/epidemiologia , Desnutrição/prevenção & controle
6.
Gac Med Mex ; 156(5): 430-438, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33372925

RESUMO

Medicine is characterized by the application of the scientific method through clinical judgment, by correct interpretation and use of the clinical course and/or natural history of the disease; its best description is observed in the architecture of clinical research. Through a temporal sequence, this model explains the phenomenon of causality with three sections: baseline status, maneuver, and outcome. The baseline status assesses who the patient is, where does he come from, his general conditions, the diagnosis, stage and aggressiveness of the pathology, complications, previous therapies, socioeconomic-cultural level, habits, therapeutic indications or contraindications, and the expected evolution is anticipated. In the maneuver, risk or prognostic factors, specific or symptomatic treatment, and general measures can be evaluated. In the outcome, early and late evolution are monitored. The model also allows the causes of follow-up loss to be determined. Anticipating patient evolution by recognizing his condition, disease, and expected effect of medical decisions allows acting in advance, since waiting for the manifestations of the evolutionary process of disease results in detriment to the patient.


La medicina se caracteriza por la aplicación del método científico a través del juicio clínico, por la correcta interpretación y el uso del curso clínico o historia natural de la enfermedad; su descripción más lograda la observamos en la arquitectura de la investigación clínica. A través de una secuencia temporal, este modelo explica el fenómeno de causalidad con tres apartados: estado basal, maniobra y desenlace. En el estado basal se evalúa quién es el paciente, de donde proviene, sus condiciones generales, el diagnóstico, el estadio y la agresividad de la patología, las complicaciones, terapias previas, nivel socioeconómi­co-cultural, hábitos, indicaciones o contraindicaciones terapéuticas y se prevé la evolución esperada. De la maniobra se pueden evaluar los factores de riesgo o pronóstico, tratamiento específico, sintomático y medidas generales. En el desenlace se vigila la evolución temprana y tardía. El modelo también permite determinar las causas de pérdida de seguimiento. Anticipar la evo­lución del paciente al reconocer su condición, enfermedad y efecto esperado de la decisiones médicas permite actuar antici­padamente, ya que esperar las manifestaciones del proceso evolutivo de la enfermedad resulta en detrimento del paciente.


Assuntos
Pesquisa Biomédica/métodos , Causalidade , Raciocínio Clínico , Pacientes , Contraindicações , Hábitos , Humanos , Perda de Seguimento , Prognóstico , Fatores Socioeconômicos , Tempo , Resultado do Tratamento
7.
Gac Med Mex ; 156(6): 499-508, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33877118

RESUMO

INTRODUCTION: Child malnutrition in Mexico reaches a prevalence as high as 27.5 % in rural areas. OBJECTIVE: To assess the effectiveness of a ready-to-use supplementary food (RUSF) to correct mild acute malnutrition and prevent moderate acute malnutrition in preschool children from rural communities. METHOD: Randomized clinical trial, with assignment to two groups: group with RUSF (RUSF-g) or group without it (non-RUSF-g); children aged from two to five years, with weight-for-height Z-scores (WHZ) between -2 and -1 and low socioeconomic status were included. All received education on nutrition, health and hygiene twice monthly; the RUSF-g children had to consume one portion of the supplement every day. WHZ was assessed at baseline and at four, six, and 12 months. The comparison between groups was carried out with Cox proportional hazards model. RESULTS: With regard to mild acute malnutrition correction in the RUSF-g, 68.7 versus 52.1 % in the control group was observed in the intent-to-treat analysis, with a hazard ratio (HR) = 1.25; in the per-protocol analysis of first semester, a HR = 1.48 was observed, and in the second semester, HR = 1.56. One patient progressed to moderate acute malnutrition. CONCLUSIONS: The RUSF-g showed a significantly higher resolution of mild acute malnutrition. INTRODUCCIÓN: La desnutrición infantil en México alcanza prevalencias de 27.5 % en zonas rurales. OBJETIVO: Evaluar la efectividad de un suplemento alimenticio listo para consumir (SALC) para corregir desnutrición aguda leve y prevenir desnutrición aguda moderada en preescolares de comunidades rurales. MÉTODO: Ensayo clínico aleatorizado por grupos: con y sin SALC (g-SALC y g-S/SALC); se incluyeron niños de dos a cinco años, con puntuaciones-Z de peso para la talla (pZ-P/T) mayor de −2 y menor de −1 y nivel socioeconómico bajo. Todos recibieron educación sobre nutrición, salud e higiene dos veces al mes; los niños del g-SALC debieron consumir diariamente una porción del suplemento. Se evaluó pZ-P/T al inicio y a los cuatro, seis y 12 meses. La comparación entre grupos se realizó con el modelo de riesgos proporcionales de Cox. RESULTADOS: Respecto a la recuperación de desnutrición aguda leve, en g-SALC se observó 68.7 versus 52.1 % en el grupo control en el análisis de intención para tratar, con una razón de riesgo (HR) = 1.25; en el análisis por protocolo del primer semestre se observó una HR = 1.48 y en el segundo semestre, HR = 1.56. Un paciente progresó a desnutrición aguda moderada. CONCLUSIONES: El g-SALC mostró resolución significativamente mayor de desnutrición aguda leve.


Assuntos
Transtornos da Nutrição Infantil/prevenção & controle , Suplementos Nutricionais , Fast Foods , População Rural , Doença Aguda , Transtornos da Nutrição Infantil/epidemiologia , Pré-Escolar , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , México/epidemiologia , Prevalência , Modelos de Riscos Proporcionais , População Rural/estatística & dados numéricos , Classe Social , Fatores de Tempo
8.
Gac Med Mex ; 156(2): 117-123, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32285859

RESUMO

INTRODUCTION: Children and adolescents weight and height are a reflection of the health status and socioeconomic development of a population. OBJECTIVE: To evaluate height and weight progression patterns of Mexican children and compare them with Dr. Ramos-Galván growth charts 40 years later. METHOD: Cross-sectional survey conducted on the population of the National Physical Activation Program "Ponte al 100", which includes boys and girls aged six to 12 years. RESULTS: 43,670 boys and 44,103 girls were assessed, stratified by gender and age. The height progression pattern between six and 12 years was 21 cm in males and 22 cm in females, whereas the weight progression pattern was 9.86 and 10.05 kg, respectively, for males and females. The proportion of six- and 12-year-old boys who were overweight was 11.2 and 9 %, while 14.7 and 15 % were obese. The proportion of six- and 12-year-old girls who were overweight was 8.2 and 9.1 %, whereas 21.7 and 13.3 %, respectively, were obese. When the obtained values were compared with those of Dr. Ramos Galván growth charts for boys and girls, the average difference was 2 cm. CONCLUSIONS: No secular height or weight increase within the last 40 years was documented.


INTRODUCCIÓN: El peso y la talla de niños y adolescentes son un reflejo del estado de salud y desarrollo socioeconómico de la población. OBJETIVO: Evaluar las progresiones de talla y peso de niños y niñas mexicanos y compararlas con las tablas del doctor Ramos Galván a 40 años de distancia. MÉTODO: Encuesta transversal realizada en población del Programa Nacional de Activación Física Ponte al 100, que incluye niños y niñas de seis a 12 años. RESULTADOS: Se evaluaron 43 670 niños y 44 103 niñas, que se estratificaron por sexo y edad. La progresión de talla entre los seis y 12 años fue de 21 cm en hombres y de 22 cm en mujeres; la progresión de peso fue de 9.86 y 10.05 kg, respectivamente para hombres y mujeres. La proporción de niños de seis y 12 años con sobrepeso fue de 11.2 y 9 % y con obesidad, de 14.7 y 15 %. La proporción de niñas de seis y 12 años con sobrepeso fue de 8.2 y 9.1 % y con obesidad, de 21.7 y 13.3 %, respectivamente. Al comparar los valores obtenidos con los de las tablas del doctor Ramos Galván para niños y niñas, el promedio de diferencia ue de 2 cm. CONCLUSIONES: No se documentó un incremento secular de la talla ni del peso en los últimos 40 años.


Assuntos
Estatura , Peso Corporal , Criança , Estudos Transversais , Feminino , Gráficos de Crescimento , Humanos , Masculino , México , Pessoa de Meia-Idade , Fatores de Tempo
9.
Gac Med Mex ; 156(5): 424-429, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33372928

RESUMO

BACKGROUND: Increased pulse pressure (IPP) is associated with an estimated glomerular filtration ≤ 60/mL/min/1.73 m2; thus, it can be useful as a diagnostic test to identify people with K/DOQI stage III-b chronic kidney disease (CKD). OBJECTIVE: To determine the usefulness of IPP as a diagnostic test for K/DOQI stage III-b CKD. METHOD: Diagnostic test study that included adult patients without comorbidities, registered in the Health Workers Cohort. The CKD-EPI formula was used to calculate glomerular filtration. Pulse pressure was determined by subtracting diastolic from systolic blood pressure. Sensitivity, specificity, positive predictive value, negative predictive value and prevalence were calculated using standard formulas. A ROC curve was generated to determine the area under the curve. RESULTS: A total of 6,215 patients were included. An IPP ≥ 50 mmHg was observed to have a sensitivity of 74 %, specificity of 70 %, positive predictive value of 1 %, negative predictive value of 100 % and a prevalence of 1 %. The inflection point in the ROC curve to identify K/DOQI III-b CKD was 0.71. CONCLUSION: An IPP ≥ 50 mmHg is useful as a diagnostic test to identify people with K/DOQI stage III-b CKD.


INTRODUCCIÓN: La presión de pulso ampliada (PPA) se asocia a un filtrado glomerular calculado ≤ 60/mL/minuto/1.73 m2, por lo que puede ser útil como prueba diagnóstica para identificar a personas con insuficiencia renal crónica (IRC) estadio K/DOQI III-b. OBJETIVO: Determinar la utilidad de la PPA como prueba diagnóstica de IRC estadio K/DOQI III-b. MÉTODO: Estudio de prueba diagnóstica que incluyó a pacientes adultos sin comorbilidades, registrados en la Cohorte de Trabajadores de la Salud. Se utilizó la fórmula CKD-EPI para calcular la filtración glomerular. Se determinó la presión de pulso restando la presión arterial diastólica a la presión arterial sistólica. Se calculó sensibilidad, especificidad, valor predictivo positivo, valor predictivo negativo y prevalencia. Se elaboró una curva ROC para determinar el área bajo la curva. RESULTADOS: Se incluyeron 6215 pacientes. Se observó que una PPA ≥ 50 mm Hg tuvo sensibilidad de 74 %, especificidad de 70 %, valor predictivo positivo de 1 %, valor predictivo negativo de 100 % y prevalencia de 1 %. El punto de inflexión en la curva ROC para identificar IRC K/DOQI III-b fue de 0.71. CONCLUSIÓN: La PPA ≥ 50 mm Hg es útil como prueba diagnóstica para identificar a personas con IRC estadio K/DOQI III-b.


Assuntos
Pressão Sanguínea/fisiologia , Insuficiência Renal Crônica/diagnóstico , Adulto , Área Sob a Curva , Determinação da Pressão Arterial/métodos , Feminino , Taxa de Filtração Glomerular/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Curva ROC , Insuficiência Renal Crônica/fisiopatologia , Sensibilidade e Especificidade , Adulto Jovem
10.
Gac Med Mex ; 155(4): 399-405, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31486784

RESUMO

Research designs refer to the way information is obtained and are limited by ethical, economic and temporal viability. Research designs are standardized strategies to reduce biases, which in the architectural model of research are identified in the baseline state, the maneuver and the outcome; hence, there are no specific designs for each question. The design with the lowest probability of bias is the clinical trial, followed by cohort and case-control studies and, finally, by cross-sectional surveys. Among the main characteristics that give merit to research designs are the following: population inquiry, which refers to the situation of the population in relation to the clinical course/natural history of the disease; the maneuver, or action that is expected to modify the baseline state, which can be observational or experimental; follow-up, or documented monitoring that is given to each subject, which can be longitudinal or cross-sectional; and directionality, which can prolective or retrolective and refers to the timing of data collection for research purposes. It will always be better having a valuable question, even when answered with a design with higher risk of bias, than a question that is irrelevant or has no applicability.


Los diseños de investigación se refieren a la forma como se obtiene la información y están limitados por viabilidad ética, económica y temporal. Son estrategias estandarizadas para disminuir los sesgos que en el modelo arquitectónico de la investigación se identifican en el estado basal, maniobra y desenlace; de ahí que no hay diseños específicos para cada pregunta. El diseño con menor probabilidad de sesgos es el ensayo clínico, seguido de la cohorte, el estudio de casos y controles y, finalmente, la encuesta transversal. Entre las principales características que dan mérito a los diseños están las siguientes: la pesquisa de la población, que se refiere a la ubicación de la población en relación con el curso clínico o historia natural de la enfermedad; la maniobra, o acción que se espera modifique la condición basal, que puede ser observacional o experimental; el seguimiento, o monitoreo documentado que se le da a cada sujeto, que puede ser longitudinal o transversal; y la direccionalidad, prolectiva o retrolectiva, que alude al tiempo de recopilación de la información con fines de investigación. Siempre será mejor tener una pregunta valiosa, incluso cuando se responda con un diseño con mayor riesgo de sesgos, que una pregunta irrelevante o sin aplicabilidad.


Assuntos
Ensaios Clínicos como Assunto/métodos , Estudos Epidemiológicos , Projetos de Pesquisa , Viés , Ensaios Clínicos como Assunto/normas , Estudos de Coortes , Confiabilidade dos Dados , Coleta de Dados/métodos , Humanos
11.
Gac Med Mex ; 155(2): 168-175, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31056591

RESUMO

A clinical research question requires the concurrence of clinical experience and knowledge on methodology and statistics in that who formulates it. Initially, a research question should have a structure that clearly establishes what is that which is being sought (consequence or outcome), in whom (baseline status), and by action of what (maneuver). Subsequently, its reasoning must explore four aspects: feasibility and reasonableness of the questioning, lack of a prior answer, relevance of the answer to be obtained, and applicability. Once these aspects are satisfactorily covered, the question can be regarded as being "clinically relevant", which is different from being statistically significant, which refers to the probability of the result being driven by chance, which does not reflect the relevance of the question or the outcome. One should never forget that every maneuver entails adverse events that, when serious, discredit good results. It is imperative to have the possible answer estimated from within the structure of the question. The function of clinical research is to corroborate or reject a hypothesis, rather than to empirically test to find out what the outcome is.


La formulación de una pregunta de investigación clínica requiere la concurrencia de experiencia clínica y conocimiento en metodología y estadística. Inicialmente, la pregunta de investigación debe contar con una estructura que deje claro qué se busca (consecuencia o desenlace), en quién (estado basal) y por acción de qué (maniobra). Posteriormente, su argumentación debe explorar cuatro aspectos: factibilidad y sensatez del cuestionamiento, ausencia de respuesta previa, relevancia de la respuesta a obtener y aplicabilidad. Una vez que estos aspectos han sido cubiertos en forma satisfactoria puede considerarse que la pregunta es "clínicamente relevante", que es diferente a significancia estadística (la probabilidad de que el resultado se deba al azar y que no refleja la relevancia de la pregunta ni de los resultados). Nunca se debe olvidar que toda maniobra conlleva eventos adversos, que cuando son graves demeritan los buenos resultados. Es imperativo estimar la posible respuesta desde la estructura de la pregunta; la función de la investigación clínica es corroborar o rechazar una hipótesis, no probar empíricamente para ver qué resulta.


Assuntos
Pesquisa Biomédica/métodos , Interpretação Estatística de Dados , Projetos de Pesquisa , Humanos
12.
Gac Med Mex ; 153(1): 49-56, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28128806

RESUMO

OBJECTIVE: To evaluate the association of the V249I and T280M variants of CX3CR1 fractalkine gene with carotid intima-media thickness in Mexican subjects with and without type 2 diabetes. METHODS: We analyzed the V249I and T280M variants of the CX3CR1 receptor by TaqMan assays in 111 subjects with type 2 diabetes and 109 healthy controls. Hemoglobin A1c, glucose, and lipid profile were determined. RESULTS: A significant increase in carotid intima-media thickness was observed in type 2 diabetes patients (0.979 ± 0.361 mm) compared to healthy controls (0.588 ± 0.175 mm). In subjects carrying the MM variant of the T280M polymorphism, hemoglobin A1c was higher (p = 0.008). Classic risk factors for atherosclerosis showed no differences between carriers of the T280M and V249I variants. Controls with the II249 genotype associated with carotid intima-media thickness (0.747 ± 0.192 mm; p = 0.041), and this difference remained significant even after adjusting factors such as age, gender, and body mass index (OR: 7.7; 95% CI: 1.269-47.31; p = 0.027). CONCLUSIONS: V249I genotype of the fractalkine receptor showed a protector role in patients with type 2 diabetes. The T280M genotype is associated with increased carotid intima-media thickness in Mexican individuals with or without type 2 diabetes.


Assuntos
Espessura Intima-Media Carotídea , Diabetes Mellitus Tipo 2/diagnóstico por imagem , Diabetes Mellitus Tipo 2/genética , Receptores de Quimiocinas/genética , Adulto , Receptor 1 de Quimiocina CX3C , Feminino , Variação Genética , Genótipo , Humanos , Masculino , México , Pessoa de Meia-Idade
13.
BMC Musculoskelet Disord ; 17(1): 437, 2016 10 19.
Artigo em Inglês | MEDLINE | ID: mdl-27756278

RESUMO

BACKGROUND: Many factors, such as heredity, ethnicity, nutrition and other lifestyle factors, have been related to bone mineral density in postmenopausal women. Additionally, bone mass has been significantly associated with decreased estrogen levels. However, fewstudies have been conducted on premenopausal women. The present study was designed to estimate the relationship between low bone mineral density and levels of serum estradiol and lifestyle factors in premenopausal Mexican women. METHODS: A cross-sectional study was conducted in 270 women between 40 and 48 years of age who participate in the Health Workers Cohort Study. Information on socio-demographic and lifestyle factors were obtained through a self-administered questionnaire. Body mass index and serum estradiol were measured with standard procedures; bone mineral density was assessed using dual-energy X-ray absorptiometry. Multiple linear and logistic regression models were computed to evaluate the relationship between low bone mineral density and levels of serum estradiol and lifestyle factors. RESULTS: In linear regression analysis levels of estradiol, body mass index, physical activity, and vitamin D intake were positively related to bone mineral density. Age, cigarette smoking and caffeine were inversely associated with BMD. Finally, the odds of low bone mineral density increase significantly when the premenopausal women had low levels of serum estradiol (OR = 4.93, 95 % CI: 2.14, 11.37). CONCLUSION: These data support that low serum estradiol, advancing age, lower physical activity, lower vitamin D intake, cigarette smoking, and higher amount of caffeine intake are linked to low bone mineral density in premenopausal Mexican women.


Assuntos
Densidade Óssea , Estradiol/sangue , Estilo de Vida , Osteoporose/sangue , Pré-Menopausa/sangue , Absorciometria de Fóton , Adulto , Fatores Etários , Índice de Massa Corporal , Cafeína/efeitos adversos , Cálcio da Dieta/administração & dosagem , Estudos de Coortes , Estudos Transversais , Suplementos Nutricionais , Exercício Físico , Feminino , Humanos , México , Pessoa de Meia-Idade , Fumar/efeitos adversos , Inquéritos e Questionários , Vitamina D/administração & dosagem
14.
Salud Publica Mex ; 58(6): 708-716, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-28225947

RESUMO

OBJECTIVE:: To examine different health outcomes that are associated with specific lifestyle and genetic factors. MATERIALS AND METHODS:: From March 2004 to April 2006, a sample of employees from three different health and academic institutions, as well as their family members, were enrolled in the study after providing informed consent. At baseline and follow-up (2010-2013), participants completed a self-administered questionnaire, a physical examination, and provided blood samples. RESULTS:: A total of 10 729 participants aged 6 to 94 years were recruited at baseline. Of these, 70% were females, and 50% were from the Mexican Social Security Institute. Nearly 42% of the adults in the sample were overweight, while 20% were obese. CONCLUSION:: Our study can offer new insights into disease mechanisms and prevention through the analysis of risk factor information in a large sample of Mexicans.


Assuntos
Doença/etiologia , Família , Pessoal de Saúde , Inquéritos Epidemiológicos/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Estudos de Coortes , Feminino , Humanos , Estilo de Vida , Masculino , México , Pessoa de Meia-Idade , Exame Físico , Prevenção Primária/métodos , Projetos de Pesquisa , Fatores de Risco
15.
Liver Int ; 35(11): 2358-62, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26248955

RESUMO

BACKGROUND & AIMS: Thrombocytopaenia and hypoalbuminaemia are surrogate markers for portal hypertension and hepatic synthetic dysfunction respectively. Patients infected with hepatitis C virus (HCV) with these surrogates have reduced likelihood of sustained virologic response and increased risk for hepatic decompensation or death when treated with peginterferon/ribavirin plus either telaprevir or boceprevir. METHODS: We conducted a post-hoc analysis of the TURQUOISE-II clinical trial in patients with cirrhosis to examine the impact of these surrogates on efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. RESULTS: Of 380 genotype 1-infected patients in TURQUOISE-II, 104 had either a platelet count <100 × 10(9)/L or albumin <3.5 g/dl. Sustained virologic response rates were 89 and 97% in patients with thrombocytopaenia, and 84 and 89% in patients with hypoalbuminaemia after 12 and 24 weeks of ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin respectively. These rates were similar to those observed in the overall study population (92 and 97% for 12 and 24 weeks). HCV genotype 1a-infected patients with thrombocytopaenia or hypoalbuminaemia had higher response rates when treated for 24 weeks, whereas only 1 of 35 genotype 1b patients did not achieve a sustained virologic response. Adverse event rates and discontinuations because of adverse events were low. CONCLUSIONS: The findings of these analyses support the use of ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin in these subpopulations with cirrhosis. Genotype 1a-infected patients with indicators of portal hypertension may benefit from a 24-week treatment duration.


Assuntos
Anilidas/uso terapêutico , Antivirais/uso terapêutico , Carbamatos/uso terapêutico , Hepatite C Crônica/tratamento farmacológico , Compostos Macrocíclicos/uso terapêutico , Ribavirina/uso terapêutico , Sulfonamidas/uso terapêutico , Uracila/análogos & derivados , 2-Naftilamina , Adolescente , Adulto , Idoso , Ciclopropanos , Farmacorresistência Viral , Quimioterapia Combinada , Feminino , Genótipo , Hepacivirus/genética , Hepatite C Crônica/complicações , Humanos , Hipertensão Portal/fisiopatologia , Hipoalbuminemia/tratamento farmacológico , Lactamas Macrocíclicas , Cirrose Hepática/virologia , Masculino , Pessoa de Meia-Idade , Prolina/análogos & derivados , Trombocitopenia/tratamento farmacológico , Resultado do Tratamento , Uracila/uso terapêutico , Valina , Adulto Jovem
16.
J Clin Densitom ; 18(1): 68-75, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-24565831

RESUMO

The purpose of this study was to assess the bone speed of sound (SoS) through lifetime of a large Mexican population sample by determining the SoS from the radius and tibia using quantitative ultrasound (QUS). This is a cross-sectional evaluation of participants in the Mexican Health Workers Cohort Study. QUS measurements were performed using Sunlight Omnisense 8000P; Z- and T-scores were calculated for both sexes at the distal third of the radius and midshaft tibia, both on the nondominant side. A locally weighted regression smoothing scatterplot model was used to identify different phases of bone accretion and loss. A total of 9128 participants aged 1-75 yr were measured with QUS. Bone SoS accretion began 5 yr earlier in girls than boys (p<0.05). Maximal SoS or peak bone SoS was noted at 28 yr in the radius and at 22 yr in the tibia. Postmenopausal women (45-50 yr) showed significant SOS decrease at both sites (p<0.05) compared with men. Using the locally weighted regression smoothing scatterplot model, we found 5 different phases that constitute the biological development of bone over the life course, from ages 1-6, 7-12, 12-25, 25-50, and 50-75 yr (p<0.05). Our study shows the age- and sex-dependent changes and different phases of bone development expressed by SoS measurements of the radius and tibia. The values reported in this study can be used as a reference for urban Mexican population.


Assuntos
Densidade Óssea , Desenvolvimento Ósseo/fisiologia , Rádio (Anatomia) , Som , Tíbia , Adulto , Fatores Etários , Idoso , Criança , Estudos de Coortes , Estudos Transversais , Feminino , Humanos , Lactente , Masculino , México , Rádio (Anatomia)/diagnóstico por imagem , Rádio (Anatomia)/fisiologia , Valores de Referência , Fatores Sexuais , Tíbia/diagnóstico por imagem , Tíbia/fisiologia , Ultrassonografia/métodos , População Urbana
17.
Rev Invest Clin ; 67(4): 240-9, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26426590

RESUMO

BACKGROUND: Type 2 diabetes is strongly linked to an increased incidence of cardiovascular outcomes. Carotid artery intima-media thickness and ankle-arm index are non-invasive complementary measures as subclinical markers of atherosclerosis. OBJECTIVE: To evaluate the association of carotid intima-media thickness, ankle-arm index, and inflammation profile in Mexican patients with early- and late-onset type 2 diabetes mellitus. MATERIAL AND METHODS: We included 145 subjects at an academic medical center: 77 patients with early-onset (< 40 years of age) and 33 patients with late-onset (≥ 40 years) type 2 diabetes mellitus, and 35 healthy volunteers. Clinical history, anthropometrics, blood chemistry, lipids profile, glycosylated hemoglobin A1c, cytokines, and high-sensitivity C-reactive protein were determined; carotid and lower limb ultrasound were taken. Groups were compared with ANOVA or Kruskal-Wallis, Student's t or Mann-Whitney U. Spearman or Pearson correlation and logistic regression analysis were used. RESULTS: There were anthropometric and biochemical differences between the three groups. Concentrations of interleukin-1ß, -4 and -6 were significantly higher in patients with late versus early onset diabetes. There were differences in carotid intima-media thickness and ankle-arm index between early and late onset. Age, body mass index, high-density lipoprotein cholesterol, high-sensitivity C-reactive protein, waist circumference, and glycosylated hemoglobin A1c showed direct correlation with carotid intima-media thickness, while ankle-arm index showed inverse correlation with blood pressure, glycosylated hemoglobin A1c, time with disease, age at onset, triglycerides, and fibrinogen. Multivariate analysis showed an association between carotid intima-media thickness and disease duration; ankle-arm index with disease duration and high-sensitivity C-reactive protein; while only body mass index associated with end diastolic flow velocity. CONCLUSIONS: Our findings suggest that carotid intima-media thickness and ankle-arm index are associated with inflammation markers and could be included in the evaluation of type 2 diabetes mellitus patients, according to disease onset and duration. There are important differences in interleukin concentrations between early- and late-onset type 2 diabetes mellitus. Additionally, measurement of high-sensitivity C-reactive protein is suggested in patients with abnormal ankle-arm index.


Assuntos
Índice Tornozelo-Braço , Espessura Intima-Media Carotídea , Diabetes Mellitus Tipo 2/patologia , Inflamação/patologia , Adulto , Idade de Início , Aterosclerose , Índice de Massa Corporal , Proteína C-Reativa/metabolismo , Estudos Transversais , Diabetes Mellitus Tipo 2/complicações , Feminino , Humanos , Interleucina-1beta/metabolismo , Interleucina-4/metabolismo , Interleucina-6/metabolismo , Lipídeos/sangue , Masculino , México , Pessoa de Meia-Idade , Adulto Jovem
18.
J Hepatol ; 61(6): 1238-46, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25064437

RESUMO

BACKGROUND & AIMS: Peginterferon lambda-1a (Lambda) is a type-III interferon with similar antiviral activity to alfa interferons but with a diminished extrahepatic receptor distribution, reducing the risk for extrahepatic adverse events. METHODS: This was a randomized, blinded, actively-controlled, multicentre phase 2b dose-ranging study in patients chronically infected with HCV genotypes 1-4. Treatment-naive patients received Lambda (120/180/240 µg) or peginterferon alfa-2a (alfa; 180 µg) once-weekly with ribavirin for 24 (genotypes [GT] 2,3) or 48 (GT1,4) weeks. RESULTS: Rates of undetectable HCV-RNA at week 12 (complete early virologic response [cEVR]; primary end point) were significantly higher in GT1,4 patients receiving Lambda vs. alfa (170/304, 56% vs. 38/103, 37%); with similar cEVR rates for GT2,3 (80/88, 91% vs. 26/30, 87%). Rates of undetectable HCV-RNA at week 4 were significantly higher on 180 µg (15/102, 15% GT1,4; 22/29, 76% GT2,3) and 240 µg (17/104, 16% GT1,4; 20/30, 67% GT2,3) Lambda than alfa (6/103, 6% GT1,4; 9/30, 30% GT2,3). Sustained virologic responses (post-treatment week 24) were comparable between Lambda and alfa for GT1,4 (37-46% Lambda; 37% alfa) and GT2,3 (60-76% Lambda; 53% alfa). Aminotransferase and/or bilirubin elevations were the primary dose-limiting abnormalities for Lambda; a sponsor-mandated 240 to 180 µg dose reduction was therefore implemented. Serious adverse events were comparable (3-13% Lambda; 3-7% alfa). Grade 3-4 haemoglobin, neutrophil, and platelet reductions were lower on Lambda than alfa. Among alfa patients, 28/133 (21%) had peginterferon and 31/133 (23%) had ribavirin dose reductions for haematologic abnormalities vs. 0/392 and 8/392 (2%) on Lambda. Lambda demonstrated fewer musculoskeletal (16-28% vs. 47-63%) and influenza-like events (8-23% vs. 40-46%) than alfa. CONCLUSION: Lambda was associated with improved or similar rates of virologic response with fewer extrahepatic adverse events than alfa in chronic HCV infection.


Assuntos
Antivirais/uso terapêutico , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/genética , Interferons/uso terapêutico , Relação Dose-Resposta a Droga , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Genótipo , Hepatite C Crônica/sangue , Humanos , Interferon-alfa/uso terapêutico , Interleucinas/uso terapêutico , Masculino , Pessoa de Meia-Idade , Polietilenoglicóis/uso terapêutico , RNA Viral/sangue , Proteínas Recombinantes/uso terapêutico , Ribavirina/uso terapêutico , Resultado do Tratamento
19.
J Gastroenterol Hepatol ; 29(3): 545-53, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24090188

RESUMO

BACKGROUND AND AIM: Chronic hepatitis C virus (HCV) infection is relatively frequent in China. This study investigated the clinical, demographic, and viral and host genetic characteristics that may influence disease manifestations and clinical management. METHODS: In this cross-sectional observational study, treatment-naïve Han ethnic adults with recently confirmed chronic HCV infection were enrolled at 28 hospitals across China. HCV genotype and host interleukin 28B (IL28B) genotypes were determined and compared with patient demographic parameters and medical status. RESULTS: Among the 997 HCV-positive patients analyzed, 56.8% were infected with HCV genotype 1b, followed in prevalence by genotypes 2, 3, and 6, with substantial regional variation. Overall, 84.1% of patients were IL28B genotype CC (rs12979860), with little regional variation. Cirrhosis was reported in 10.1% of patients and was significantly associated with hepatitis B virus coinfection, low HCV viral load, low serum alanine aminotransferase, high serum aspartate aminotransferase, diabetes, and high pickled food consumption. Medical procedures were common transmission risk factors; however, lifestyle-associated risk factors, including intravenous drug abuse and tattoos or piercings, were more common in patients with HCV genotype 3 or 6. CONCLUSIONS: Most HCV-infected Han Chinese patients were IL28B genotype CC (rs12979860). HCV genotypes varied by geographic region, and disease characteristics differed according to HCV genotype. Relatively frequent detection of advanced liver disease may reflect limitations on access to antiviral therapy, and suggests that greater awareness of factors that influence HCV-associated disease may help avoid clinical complications and improve patient outcomes.


Assuntos
Povo Asiático/genética , Hepacivirus/genética , Hepatite C Crônica/genética , Hepatite C Crônica/virologia , Adulto , China/epidemiologia , China/etnologia , Coinfecção , Estudos Transversais , Feminino , Genótipo , Hepatite B , Hepatite C Crônica/epidemiologia , Hepatite C Crônica/transmissão , Humanos , Interferons , Interleucinas/genética , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco
20.
Pediatr Nephrol ; 29(2): 273-81, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24077647

RESUMO

OBJECTIVE: We evaluated the association between inflammation and oxidative stress with carotid intima media thickness (cIMT) and elasticity increment module (E(inc)) in pediatric patients with chronic kidney disease (CKD). METHODS: This analytical, cross-sectional study assessed 134 children aged 6-17 years with CKD. Anthropometric measurements and biochemistry of intact parathyroid hormone (iPTH), high-sensitivity C-reactive protein (CRP), interleukin (IL)-6, IL-1ß, reduced glutathione (GSH), malondialdehyde, nitric oxide, and homocysteine were recorded. Bilateral carotid ultrasound (US) was taken. Patients were compared with controls for cIMT and E(inc) using ≥ 75 percentile (PC). RESULTS: Mean cIMT was 0.528 ± 0.089 mm; E(inc) was 0.174 ± 0.121 kPa × 10(3); cIMT negatively correlated with phosphorus (r -0.19, p =0.028) and the calcium × phosphorus (Ca × P) product (r -0.26, p =0.002), and positively with iPTH (r 0.19,p =0.024). After adjusting for potential confounders, hemodialysis (HD) (ß=0.111, p =<0.001), automated peritoneal dialysis (APD) (ß=0.064, p =0.026), and Ca x P product(ß=-0.002, p =0.015) predicted cIMT (R(2)=0.296). In patients on dialysis, HD (ß=0.068, p =0.010), low-density lipoprotein cholesterol (LDL-C) (ß=0.001, p =0.048), and GSH(ß=-0.0001, p=0.041) independently predicted cIMT (R(2)=0.204); HD, hypoalbuminemia, and high iPTH increased the risk of increased cIMT. In dialysis, E(inc) was inversely associated with GSH, and in predialysis, Ca × P correlated with/predicted E(inc) (ß=0.001, p =0.009). CONCLUSIONS: cIMT and E(inc) strongly associate with several biochemical parameters and GSH but not with other oxidative stress or inflammation markers.


Assuntos
Espessura Intima-Media Carotídea , Inflamação/complicações , Estresse Oxidativo/fisiologia , Insuficiência Renal Crônica/complicações , Adolescente , Biomarcadores/análise , Criança , Pré-Escolar , Estudos Transversais , Módulo de Elasticidade , Feminino , Humanos , Masculino
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