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Introduction: Updating recommendations for guidelines requires a comprehensive and efficient literature search. Although new information platforms are available for developing groups, their relative contributions to this purpose remain uncertain. Methods: As part of a review/update of eight selected evidence-based recommendationsfor type 2 diabetes, we evaluated the following five literature search approaches (targeting systematic reviews, using predetermined criteria): PubMed for MEDLINE, Epistemonikos database basic search, Epistemonikos database using a structured search strategy, Living overview of evidence (L.OVE) platform, and TRIP database. Three reviewers independently classified the retrieved references as definitely eligible, probably eligible, or not eligible. Those falling in the same "definitely" categories for all reviewers were labelled as "true" positives/negatives. The rest went to re-assessment and if found eligible/not eligible by consensus became "false" negatives/positives, respectively. We described the yield for each approach and computed "diagnostic accuracy" measures and agreement statistics. Results: Altogether, the five approaches identified 318 to 505 references for the eight recommendations, from which reviewers considered 4.2 to 9.4% eligible after the two rounds. While Pubmed outperformed the other approaches (diagnostic odds ratio 12.5 versus 2.6 to 5.3), no single search approach returned eligible references for all recommendations. Individually, searches found up to 40% of all eligible references (n = 71), and no combination of any three approaches could find over 80% of them. Kappa statistics for retrieval between searches were very poor (9 out of 10 paired comparisons did not surpass the chance-expected agreement). Conclusion: Among the information platforms assessed, PubMed appeared to be more efficient in updating this set of recommendations. However, the very poor agreement among search approaches in the reference yield demands that developing groups add information from several (probably more than three) sources for this purpose. Further research is needed to replicate our findings and enhance our understanding of how to efficiently update recommendations.
Introducción: La actualización de recomendaciones de las guías de práctica clínica requiere búsquedas bibliográficas exhaustivas y eficientes. Aunque están disponibles nuevas plataformas de información para grupos desarrolladores, su contribución a este propósito sigue siendo incierta. Métodos: Como parte de una revisión/actualización de 8 recomendaciones basadas en evidencia seleccionadas sobre diabetes tipo 2, evaluamos las siguientes cinco aproximaciones de búsqueda bibliográfica (dirigidas a revisiones sistemáticas, utilizando criterios predeterminados): PubMed para MEDLINE; Epistemonikos utilizando una búsqueda básica; Epistemonikos utilizando una estrategia de búsqueda estructurada; plataforma (L.OVE) y TRIP . Tres revisores clasificaron de forma independiente las referencias recuperadas como definitivamente o probablemente elegibles/no elegibles. Aquellas clasificadas en las mismas categorías "definitivas" para todos los revisores, se etiquetaron como "verdaderas" positivas/negativas. El resto se sometieron a una nueva evaluación y, si se consideraban por consenso elegibles/no elegibles, se convirtieron en "falsos" negativos/positivos, respectivamente. Describimos el rendimiento de cada aproximación, junto a sus medidas de "precisión diagnóstica" y las estadísticas de acuerdo. Resultados: En conjunto, las cinco aproximaciones identificaron 318-505 referencias para las 8 recomendaciones, de las cuales los revisores consideraron elegibles el 4,2 a 9,4% tras las dos rondas. Mientras que Pubmed superó a las otras aproximaciones (odds ratio de diagnóstico 12,5 versus 2,6 a 53), ninguna aproximación de búsqueda identificó por sí misma referencias elegibles para todas las recomendaciones. Individualmente, las búsquedas identificaron hasta el 40% de todas las referencias elegibles (n=71), y ninguna combinación de cualquiera de los tres enfoques pudo identificar más del 80% de ellas. Las estadísticas Kappa para la recuperación entre búsquedas fueron muy pobres (9 de cada 10 comparaciones pareadas no superaron el acuerdo esperado por azar). Conclusiones: Entre las plataformas de información evaluadas, Pubmed parece ser la más eficiente para actualizar este conjunto de recomendaciones. Sin embargo, la escasa concordancia en el rendimiento de las referencias exige que los grupos desarrolladores incorporen información de varias fuentes (probablemente más de tres) para este fin. Es necesario seguir investigando para replicar nuestros hallazgos y mejorar nuestra comprensión de cómo actualizar recomendaciones de forma eficiente.
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Diabetes Mellitus Tipo 2 , Medicina Basada en la Evidencia , Guías de Práctica Clínica como Asunto , Humanos , Colombia , Bases de Datos Bibliográficas , Almacenamiento y Recuperación de la Información/métodos , Almacenamiento y Recuperación de la Información/normasRESUMEN
BACKGROUND: Treatment with benznidazole for chronic Chagas disease is associated with low cure rates and substantial toxicity. We aimed to compare the parasitological efficacy and safety of 3 different benznidazole regimens in adult patients with chronic Chagas disease. METHODS: The MULTIBENZ trial was an international, randomised, double-blind, phase 2b trial performed in Argentina, Brazil, Colombia, and Spain. We included participants aged 18 years and older diagnosed with Chagas disease with two different serological tests and detectable T cruzi DNA by qPCR in blood. Previously treated people, pregnant women, and people with severe cardiac forms were excluded. Participants were randomly assigned 1:1:1, using a balanced block randomisation scheme stratified by country, to receive benznidazole at three different doses: 300 mg/day for 60 days (control group), 150 mg/day for 60 days (low dose group), or 400 mg/day for 15 days (short treatment group). The primary outcome was the proportion of patients with a sustained parasitological negativity by qPCR during a follow-up period of 12 months. The primary safety outcome was the proportion of people who permanently discontinued the treatment. Both primary efficacy analysis and primary safety analysis were done in the intention-to-treat population. The trial is registered with EudraCT, 2016-003789-21, and ClinicalTrials.gov, NCT03191162, and is completed. FINDINGS: From April 20, 2017, to Sept 20, 2020, 245 people were enrolled, and 234 were randomly assigned: 78 to the control group, 77 to the low dose group, and 79 to the short treatment group. Sustained parasitological negativity was observed in 42 (54%) of 78 participants in the control group, 47 (61%) of 77 in the low dose group, and 46 (58%) of 79 in the short treatment group. Odds ratios were 1·41 (95% CI 0·69-2·88; p=0·34) when comparing the low dose and control groups and 1·23 (0·61-2·50; p=0·55) when comparing short treatment and control groups. 177 participants (76%) had an adverse event: 62 (79%) in the control group, 56 (73%) in the low dose group, and 59 (77%) in the short treatment group. However, discontinuations were less frequent in the short treatment group compared with the control group (2 [2%] vs 11 [14%]; OR 0·20, 95% CI 0·04-0·95; p=0·044). INTERPRETATION: Participants had a similar parasitological responses. However, reducing the usual treatment from 8 weeks to 2 weeks might maintain the same response while facilitating adherence and increasing treatment coverage. These findings should be confirmed in a phase 3 clinical trial. FUNDING: European Community's 7th Framework Programme.
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Enfermedad de Chagas , Nitroimidazoles , Adulto , Humanos , Enfermedad de Chagas/tratamiento farmacológico , Método Doble Ciego , Nitroimidazoles/administración & dosificación , Resultado del TratamientoRESUMEN
BACKGROUND: In previous analyses, myocardial injury after noncardiac surgery, major bleeding, and sepsis were independently associated with most deaths in the 30 days after noncardiac surgery, but most of these deaths occurred during the index hospitalization for surgery. The authors set out to describe outcomes after discharge from hospital up to 1 yr after inpatient noncardiac surgery and associations between predischarge complications and postdischarge death up to 1 yr after surgery. METHODS: This study was an analysis of patients discharged after inpatient noncardiac surgery in a large international prospective cohort study across 28 centers from 2007 to 2013 of patients aged 45 yr or older followed to 1 yr after surgery. The study estimated (1) the cumulative postdischarge incidence of death and other outcomes up to a year after surgery and (2) the adjusted time-varying associations between postdischarge death and predischarge complications including myocardial injury after noncardiac surgery, major bleeding, sepsis, infection without sepsis, stroke, congestive heart failure, clinically important atrial fibrillation or flutter, amputation, venous thromboembolism, and acute kidney injury managed with dialysis. RESULTS: Among 38,898 patients discharged after surgery, the cumulative 1-yr incidence was 5.8% (95% CI, 5.5 to 6.0%) for all-cause death and 24.7% (95% CI, 24.2 to 25.1%) for all-cause hospital readmission. Predischarge complications were associated with 33.7% (95% CI, 27.2 to 40.2%) of deaths up to 30 days after discharge and 15.0% (95% CI, 12.0 to 17.9%) up to 1 yr. Most of the association with death was due to myocardial injury after noncardiac surgery (15.6% [95% CI, 9.3 to 21.9%] of deaths within 30 days, 6.4% [95% CI, 4.1 to 8.7%] within 1 yr), major bleeding (15.0% [95% CI, 8.3 to 21.7%] within 30 days, 4.7% [95% CI, 2.2 to 7.2%] within 1 yr), and sepsis (5.4% [95% CI, 2.2 to 8.6%] within 30 days, 2.1% [95% CI, 1.0 to 3.1%] within 1 yr). CONCLUSIONS: One in 18 patients 45 yr old or older discharged after inpatient noncardiac surgery died within 1 yr, and one quarter were readmitted to the hospital. The risk of death associated with predischarge perioperative complications persists for weeks to months after discharge.
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Alta del Paciente , Sepsis , Humanos , Estudios Prospectivos , Cuidados Posteriores , Hemorragia , Complicaciones Posoperatorias/epidemiología , Factores de RiesgoRESUMEN
Purpose: To compare the level of knowledge in vaccination against influenza and pneumococcus of patients with chronic obstructive pulmonary disease (COPD) who are managed in an Integrated Care Program (ICP) with those who receive usual care (UC). Methods: A telephone survey of patients diagnosed with COPD registered in public care networks or private institutions was done. A descriptive and comparative analysis of the characteristics of the ICP and UC groups was carried out. The relationship between belonging to an ICP and the level of knowledge about vaccination was evaluated using Propensity Score Matching (PSM) and multivariate logistic and ordinal regression models. Results: Of 674 study participants, 27.2% were from the ICP group. ICP patients were older, more frequently men, from a higher socioeconomic stratum and a higher educational level (p<0.05). 75.5% of the patients in the ICP group had a high level of vaccination knowledge compared to 42.7% in the UC group (p<0.001). In the multivariate analysis, adjusting for sociodemographic variables, years of COPD diagnosis, and comorbidities, belonging to the ICP was associated with a higher probability of answering questions about vaccination correctly and having a high level of knowledge (OR 3.397, IC 95% 2.058-5.608, p<0.001). Conclusion: Patients with COPD managed in an ICP have a higher level of knowledge in vaccination against influenza and pneumococcus, compared to patients in usual care.
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Prestación Integrada de Atención de Salud , Vacunas contra la Influenza , Gripe Humana , Enfermedad Pulmonar Obstructiva Crónica , Masculino , Humanos , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/terapia , Streptococcus pneumoniae , Gripe Humana/diagnóstico , Gripe Humana/epidemiología , Gripe Humana/prevención & control , VacunaciónRESUMEN
BACKGROUND: Routine blood pressure (BP) self-monitoring is recommended for patients already diagnosed with hypertension. How often these patients can report their BP levels is unknown, particularly in low-and-middle income countries. METHODS: We surveyed (January 2021 to May 2022) representative samples of patients with established diagnosis of hypertension from 3 health care networks (involving 74 outpatient clinics) and 2 university hospitals in Bogotá, Colombia. Trained health care professionals conducted a telephone survey including questions on demographics, medical history, and general understanding about hypertension and its potential complications. The outcome variables were the self-report of participant's BP levels (primary) and monitoring practices among participants. RESULTS: Out of 2609 consecutively contacted patients sampled from institutional records, 2323 were invited and 1566 (mean age 66.5, SD = 12.1 years, 74.4% females, 64.0% living low socio-economic strata) gave consent to participate. While 66% of participants had over 5 years of diagnosis, 39.5% had most (≥ 60%) of their follow-up visits with the same doctor. Overall, 645 (41.5%, 95%CI 39.1 -43.9) participants reported their BP levels. This proportion was independent of time from diagnosis, but higher among those of younger age, living in higher socio-economic strata, having more years of education and using more information technologies. Also, more patients reported their BP levels if seen ≥ 60% of the times by the same physician (43.4% Vs. 36.7%). Those reporting closer BP self-monitoring more often used electronic devices, received 2 + medications, and had better knowledge about hypertension. CONCLUSION: A minority of hypertensive patients seen in Bogotá were aware of their own BP levels. Those in such capacity were in a better social position, more often seen by the same doctor, knew their condition better and handled more complex treatments. Hypertensive patients from Bogotá may benefit from a more continuous medical care, patient education programs and promoting BP home monitoring.
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Hipertensión , Pacientes Ambulatorios , Femenino , Humanos , Anciano , Masculino , Presión Sanguínea , Colombia/epidemiología , Hipertensión/diagnóstico , Hipertensión/epidemiología , Hipertensión/terapia , Instituciones de Atención AmbulatoriaRESUMEN
OBJECTIVES: To assess the disruption of endothelial glycocalyx integrity in children with sepsis receiving fluid resuscitation with either balanced or unbalanced crystalloids. The primary outcome was endothelial glycocalyx disruption (using perfused boundary region >2 µm on sublingual video microscopy and syndecan-1 greater than 80 mg/dL) according to the type of crystalloid. The secondary outcomes were increased vascular permeability (using angiopoietin-2 level), apoptosis (using annexin A5 level), and associated clinical changes. DESIGN: A single-center prospective cohort study from January to December 2021. SETTING: Twelve medical-surgical PICU beds at a university hospital. PATIENTS: Children with sepsis/septic shock before and after receiving fluid resuscitation with crystalloids for hemodynamic instability. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We included 106 patients (3.9 yr [interquartile range, 0.60-13.10 yr]); 58 of 106 (55%) received boluses of unbalanced crystalloid. This group had greater odds of endothelial glycocalyx degradation (84.5% vs 60.4%; adjusted odds ratio, 3.78; 95% CI, 1.49-9.58; p < 0.01) 6 hours after fluid administration, which correlated with increased angiopoietin-2 (rho = 0.4; p < 0.05) and elevated annexin A5 ( p = 0.04). This group also had greater odds of metabolic acidosis associated with elevated syndecan-1 (odds ratio [OR], 4.88; 95% CI, 1.23-28.08) and acute kidney injury (OR, 1.7; 95% CI, 1.12-3.18) associated with endothelial glycocalyx damage. The perfused boundary region returned to baseline 24 hours after receiving the crystalloid boluses. CONCLUSIONS: Children with sepsis, particularly those who receive unbalanced crystalloid solutions during resuscitation, show loss and worsening of endothelial glycocalyx. The abnormality peaks at around 6 hours after fluid administration and is associated with greater odds of metabolic acidosis and acute kidney injury.
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Acidosis , Lesión Renal Aguda , Sepsis , Choque Séptico , Humanos , Niño , Sindecano-1/metabolismo , Angiopoyetina 2/metabolismo , Estudios Prospectivos , Glicocálix/metabolismo , Anexina A5/metabolismo , Sepsis/metabolismo , Soluciones Cristaloides , Fluidoterapia/efectos adversos , Lesión Renal Aguda/etiología , Lesión Renal Aguda/terapia , Lesión Renal Aguda/metabolismo , Acidosis/metabolismo , Biomarcadores/metabolismoRESUMEN
Introduction. The management of patients with chronic noncommunicable diseases, when it follows evidence-based recommendations, improves clinical outcomes and health costs. Despite its importance, little is known about adherence to guidelines and the processes for its monitoring in our environment. The objective of this study was to report the applicability and adherence to a selection of recommendations from clinical practice guidelines for noncommunicable chronic diseases by doctors in Bogotá. Methods. This was a cross-sectional study, the baseline of a cluster experiment that assessed the impact of disseminating recommendations on seven chronic diseases to patients, caregivers, and physicians. A total of 177 physicians from public and private health institutions were invited. Consecutive samples of their medical records were manually reviewed in predefined time ranges (up to 20 patients per physician, with up to two diseases of interest). The proportions of applicability and adherence were calculated according to 40 recommendations. Results. The 177 physicians who participated (out of 266 eligible) were from seven institutions, and 3,747 medical records (21,093 patients/recommendation) were analyzed. The general applicability was 31.9% (95% CI 31.3-32.6%), and it varied considerably by recommendation (range 0.3-100%) and disease (range 10.7-65%). Overall adherence was 42.0% (95% CI 40.8-43.2%), with higher adherence in acute coronary syndrome patients (58.4%) and lower adherence in diabetes mellitus patients (23.7%). Discussion. This is the most up-to-date, exhaustive, and representative measurement of adherence to guideline recommendations by doctors in Bogotá. Conclusions. Adherence to evidence-based recommendations for patients with chronic noncommunicable diseases in Bogotá is poor and highly variable. Keywords: Practice Guideline; Evidence-Based Medicine; Noncommunicable Diseases; Quality of Health Care; Implementation Science; Internal Medicine; Primary Health Care
Introducción. El manejo de pacientes con enfermedades crónicas no transmisibles, cuando se realiza a partir de recomendaciones basadas en la evidencia, mejora los desenlaces clínicos y los costos en salud. Pese a su importancia, poco se conocen la adherencia a las recomendaciones de guías y los procesos para su monitoreo en nuestro medio. El objetivo de este estudio es reportar la aplicabilidad y la adherencia a una selección de recomendaciones de guías de práctica clínica, en enfermedades crónicas no transmisibles, por médicos de Bogotá. Metodología. Estudio de corte MSc.Participaron 177 médicos de instituciones de salud públicas y privadas. Se revisaron manualmente muestras consecutivas de sus historias clínicas en rangos de tiempo predefinidos (meta hasta 20 pacientes por médico, en hasta dos enfermedades de interés). Se calcularon las proporciones de aplicabilidad y adherencia en 40 recomendaciones. Resultados. Participaron 177 médicos (de 266 elegibles), de 7 instituciones, con 3,747 historias clínicas (21,093 pacientes/recomendación) analizadas. La aplicabilidad general fue 31.9% (IC95% 31.3%-32.6%), y varió considerablemente por recomendación (rango 0.3%-100%) y enfermedad (rango 10.7%-65%). La adherencia general fue 42.0% (IC95% 40.8% -43.2%), siendo mayor en síndrome coronario agudo (58.4%) y menor en diabetes mellitus (23.7%). Discusión. Esta es la medición más actualizada, exhaustiva y representativa de la adherencia a las recomendaciones de guías por parte de médicos de Bogotá. Conclusiones. La adherencia a recomendaciones basadas en evidencia, para pacientes con enfermedades crónicas no transmisibles de Bogotá, es deficiente y altamente variable. Palabras clave: Guía de Práctica Clínica; Medicina Basada en la Evidencia; Enfermedades no Transmisibles; Calidad de la Atención de Salud; Ciencia de la Implementación; Medicina Interna; Atención Primaria de Salud
Introdução. O manejo de pacientes com doenças crônicas não transmissíveis, quando realizado com base em recomendações baseadas em evidências, melhora os resultados clínicos e os custos de saúde. Apesar da sua importância, pouco se sabe sobre a adesão às recomendações das diretrizes e os processos para monitorá-la em nosso meio. O objetivo deste estudo é relatar a aplicabilidade e adesão a uma seleção de recomendações das diretrizes de prática clínica, em doenças crônicas não transmissíveis, por médicos em Bogotá. Metodologia. Estudo transversal (linha de base de um experimento cluster que avalia o impacto da divulgação de recomendações sobre sete doenças crônicas a pacientes, cuidadores e médicos). Participaram 177 médicos de instituições de saúde públicas e privadas. Foram revisadas manualmente amostras consecutivas de seus prontuários em intervalos de tempo pré-definidos (alvo de até 20 pacientes por médico, em até duas doenças de interesse). Foram calculadas proporções de aplicabilidade e adesão para 40 recomendações. Resultados. Participaram 177 médicos (de 266 elegíveis), de 7 instituições, com 3,747 prontuários (21,093 pacientes/recomendação) analisados. A aplicabilidade geral foi de 31.9% (IC 95% 31.3%-32.6%) e variou consideravelmente por recomendação (intervalo 0.3%-100%) e doença (intervalo 10.7%-65%). A adesão geral foi de 42.0% (IC 95% 40.8%-43.2%), sendo maior na síndrome coronariana aguda (58.4%) e menor na diabetes mellitus (23.7%). Discussão. Esta é a medição mais atualizada, exaustiva e representativa da adesão às recomendações das diretrizes por médicos em Bogotá. Conclusões. A adesão às recomendações baseadas em evidências para pacientes com doenças crônicas não transmissíveis em Bogotá é fraca e altamente variável. Palavras-chave: Guia de Prática Clínica; Medicina Baseada em Evidências; Doenças não Transmissíveis; Qualidade da Assistência à Saúde; Ciência da Implementação; Medicina Interna; Atenção Primária à Saúde
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Medicina Basada en la Evidencia , Atención Primaria de Salud , Calidad de la Atención de Salud , Guía de Práctica Clínica , Enfermedades no Transmisibles , Ciencia de la Implementación , Medicina InternaRESUMEN
OBJECTIVE: Sepsis is one of the main causes of morbidity and mortality worldwide. Microcirculatory impairment, especially damage to the endothelium and glycocalyx, is often not assessed. The objective of this systematic review and meta-analysis was to summarize the available evidence of the risk of unsatisfactory outcomes in patients with sepsis and elevated glycocalyx injury and endothelial activation biomarkers. DESIGN: A systematic search was carried out on PubMed/MEDLINE, Embase, Cochrane and Google Scholar up to December 31, 2021, including studies in adults and children with sepsis which measured glycocalyx injury and endothelial activation biomarkers within 48 hours of hospital admission. The primary outcome was the risk of mortality from all causes and the secondary outcomes were the risk of developing respiratory failure (RF) and multiple organ dysfunction syndrome (MODS) in patients with elevations of these biomarkers. MEASUREMENTS AND MAIN RESULTS: A total of 17 studies (3,529 patients) were included: 11 evaluated syndecan-1 (n=2,397) and 6 endocan (n=1,132). Syndecan-1 was higher in the group of patients who died than in those who survived [255 ng/mL (IQR: 139-305) vs. 83 ng/mL (IQR:40-111); p=0.014]. Patients with elevated syndecan-1 had a greater risk of death (OR 2.32; 95% CI 1.89, 3.10: p<0.001), MODS (OR 3.3; 95% CI 1.51, 7.25: p=0.003;), or RF (OR 7.53; 95% CI 1.86-30.45: p=0.005). Endocan was higher in patients who died [3.1 ng/mL (IQR 2.3, 3.7) vs. 1.62 ng/mL (IQR 1.2, 5.7); OR 9.53; 95% CI 3.34, 27.3; p<0.001], who had MODS (OR 8.33; 95% CI 2.07, 33.58; p=0.003) and who had RF (OR 9.66; 95% CI 2.26, 43.95; p=0.002). CONCLUSION: Patients with sepsis and abnormal glycocalyx injury and endothelial activation biomarkers have a greater risk of developing respiratory failure, multiple organ failure, and death. Microcirculatory impairment should be routinely evaluated in patients with sepsis, using biomarkers to stratify risk groups.
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Insuficiencia Respiratoria , Sepsis , Adulto , Niño , Humanos , Glicocálix , Sindecano-1 , Insuficiencia Multiorgánica/etiología , Microcirculación/fisiología , Sepsis/complicaciones , Biomarcadores , EndotelioRESUMEN
OBJECTIVES: To determine the comparative efficacy and safety of a fixed dose of benznidazole (BZN) with an adjusted-dose for Trypanosoma cruzi-seropositive adults without cardiomyopathy. METHODS: We conducted a systematic review and individual participant data (IPD) meta-analysis following Cochrane methods, and the PRISMA-IPD statement for reporting. Randomised controlled trials (RCTs) allocating participants to fixed or adjusted doses of BZN for T. cruzi-seropositive adults without cardiomyopathy were included. We searched (December 2021) Cochrane, MEDLINE, EMBASE, LILACS and trial registries and contacted Chagas experts. Selection, data extraction, risk of bias assessment using the Cochrane tool, and a GRADE summary of finding tables were performed independently by pairs of reviewers. We conducted a random-effects IPD meta-analysis using the one-stage strategy, or, if that was impossible, the two-stage strategy. RESULTS: Five RCTs (1198 patients) were included, none directly comparing fixed with adjusted doses of BZN. Compared to placebo, BZN therapy was strongly associated with negative qPCR and sustainable parasitological clearance regardless of the type of dose and subgroup analysed. For negative qPCR, the fixed/adjusted rate of odds ratios (RORF/A ) was 8.83 (95% CI 1.02-76.48); for sustained parasitological clearance, it was 4.60 (95% CI 0.40-52.51), probably indicating at least non-inferior effect of fixed doses, with no statistically significant interactions by scheme for global and most subgroup estimations. The RORF/A for treatment interruption due to adverse events was 0.44 (95% CI 0.14-1.38), probably indicating no worse tolerance of fixed doses. CONCLUSIONS: We found no direct comparison between fixed and adjusted doses of BZN. However, fixed doses versus placebo are probably not inferior to weight-adjusted doses of BZN versus placebo in terms of parasitological efficacy and safety. Network IPD meta-analysis, through indirect comparisons, may well provide the best possible answers in the near future. REGISTRATION: The study protocol was registered in PROSPERO (CRD42019120905).
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Cardiomiopatías , Enfermedad de Chagas , Trypanosoma cruzi , Adulto , Humanos , Lagunas en las Evidencias , Enfermedad de Chagas/tratamiento farmacológicoRESUMEN
BACKGROUND: Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients' tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. METHODS: A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients' level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. CONCLUSION: This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. TRIAL REGISTRATION: PENFUP phase-2 was Registered in Clinicaltrials.gov ( NCT04604665 ) in October 2020.
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INTRODUCTION: Studies on Chagas disease-related mortality assist in decision-making in health policies. We analyzed the epidemiological characteristics, temporal trends, and regional differences in Chagas disease-related mortality in Colombia from 1979 to 2018. METHODS: A time-series study was conducted using death records and population data from the National Administrative Department of Statistics, using categorizations from the International Classification of Disease (ICD)-9 and ICD-10 systems. All deaths with Chagas disease as an underlying or associated cause of death were included. Crude and age-sex standardized mortality rates per 100,000 inhabitants and the annual percent change (APC) were calculated. RESULTS: Of the 7,287,461 deaths recorded in Colombia during 1979-2018, 3,276 (0.04%) deaths were related to Chagas disease-2,827 (86.3%) as an underlying cause and 449 (13.7%) as an associated cause. The average annual age-sex standardized mortality rate was 0.211 (95% confidence interval [CI]: 0.170-0.252) deaths/100,000 inhabitants, with a significant upward trend (APC = 6.60%; 95% CI: 5.9-7.3). The highest Chagas disease-related death rates were in males (0.284 deaths/100,000 inhabitants), those ≥65 years old (1.296 deaths/100,000 inhabitants), and residents of the Orinoco region (1.809 deaths/100,000 inhabitants). There was a significant increase in mortality in the Orinoco (APC = 8.28%; 95% CI: 6.4-10.2), Caribbean (APC = 5.06%; 95% CI: 3.6-6.5), and Andean (APC = 4.63%; 95% CI: 3.9-5.3) regions. CONCLUSIONS: Chagas disease remains a major public health issue in Colombia with high mortality rates in older age groups, a wide geographic distribution, regional differences, and the potential to increase.
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Enfermedad de Chagas , Anciano , Causas de Muerte , Colombia/epidemiología , Humanos , Masculino , Mortalidad , Salud PúblicaRESUMEN
Abstract INTRODUCTIOn: Studies on Chagas disease-related mortality assist in decision-making in health policies. We analyzed the epidemiological characteristics, temporal trends, and regional differences in Chagas disease-related mortality in Colombia from 1979 to 2018. METHODS: A time-series study was conducted using death records and population data from the National Administrative Department of Statistics, using categorizations from the International Classification of Disease (ICD)-9 and ICD-10 systems. All deaths with Chagas disease as an underlying or associated cause of death were included. Crude and age-sex standardized mortality rates per 100,000 inhabitants and the annual percent change (APC) were calculated. RESULTS: Of the 7,287,461 deaths recorded in Colombia during 1979-2018, 3,276 (0.04%) deaths were related to Chagas disease-2,827 (86.3%) as an underlying cause and 449 (13.7%) as an associated cause. The average annual age-sex standardized mortality rate was 0.211 (95% confidence interval [CI]: 0.170-0.252) deaths/100,000 inhabitants, with a significant upward trend (APC = 6.60%; 95% CI: 5.9-7.3). The highest Chagas disease-related death rates were in males (0.284 deaths/100,000 inhabitants), those ≥65 years old (1.296 deaths/100,000 inhabitants), and residents of the Orinoco region (1.809 deaths/100,000 inhabitants). There was a significant increase in mortality in the Orinoco (APC = 8.28%; 95% CI: 6.4-10.2), Caribbean (APC = 5.06%; 95% CI: 3.6-6.5), and Andean (APC = 4.63%; 95% CI: 3.9-5.3) regions. CONCLUSIONS: Chagas disease remains a major public health issue in Colombia with high mortality rates in older age groups, a wide geographic distribution, regional differences, and the potential to increase.
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Humanos , Masculino , Anciano , Enfermedad de Chagas , Salud Pública , Mortalidad , Causas de Muerte , Colombia/epidemiologíaRESUMEN
Chagas disease is a neglected disease that remains a public health threat, particularly in Latin America. The most important treatment options are nitroimidazole derivatives, such as nifurtimox and benznidazole (BZN). Some studies suggest that for adults seropositive to T. cruzi but without clinically evident chronic Chagas cardiomyopathy (CCC), a simple fixed-dose scheme of BZN could be equivalent to a weight-adjusted dose. We compared the efficacy and safety of a fixed dose of BZN with an adjusted dose for T. cruzi seropositive adults without CCC. We used the Cochrane methods, and reported according to the PRISMA statement. We included randomized controlled trials (RCTs) allocating participants to fixed and/or adjusted doses of BZN for T. cruzi seropositive adults without CCC. We searched (December 2019) Cochrane, MEDLINE, EMBASE, LILACS, Clinicaltrials.gov, and International Clinical Trials Registry Platform (ICTRP), and contacted Chagas experts. Selection, data extraction, and risk of bias assessment, using the Cochrane tool, were performed independently by pairs of reviewers. Discrepancies were solved by consensus within the team. Primary outcomes were parasite-related outcomes and efficacy or patient-related safety outcomes. We conducted a meta-analysis using RevMan 5.3 software and used GRADE summary of finding tables to present the certainty of evidence by outcome. We identified 655 records through our search strategy and 10 studies (four of them ongoing) met our inclusion criteria. We did not find any study directly comparing fixed vs adjusted doses of BZN, however, some outcomes allowed subgroup comparisons between fixed and adjusted doses of BZN against placebo. Moderate-certainty evidence suggests no important subgroup differences for positive PCR at one year and for three safety outcomes (drug discontinuation, peripheral neuropathy, and mild rash). The same effect was observed for any serious adverse events (low-certainty evidence). All subgroups showed similar effects (I2 0% for all these subgroup comparisons but 32% for peripheral neuropathy), supporting the equivalence of BZN schemes. We conclude that there is no direct evidence comparing fixed and adjusted doses of BZN. Based on low to very low certainty of evidence for critical clinical outcomes and moderate certainty of evidence for important outcomes, fixed and adjusted doses may be equivalent in terms of safety and efficacy. An individual patient data network meta-analysis could better address this issue.
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Cardiomiopatías , Enfermedad de Chagas/tratamiento farmacológico , Nitroimidazoles/administración & dosificación , Nitroimidazoles/uso terapéutico , Adulto , Bases de Datos Factuales , Humanos , Nifurtimox/uso terapéutico , Seguridad del Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Triazoles/uso terapéutico , Trypanosoma cruzi/efectos de los fármacosRESUMEN
BACKGROUND: Myocardial injury after noncardiac surgery (MINS) is common and of prognostic importance. Little is known about MINS in orthopaedic surgery. The diagnostic criterion for MINS was a level of ≥0.03 ng/mL on a non-high-sensitivity troponin T (TnT) assay due to myocardial ischemia. METHODS: We undertook an international, prospective study of 15,103 patients ≥45 years of age who had inpatient noncardiac surgery; 3,092 underwent orthopaedic surgery. Non-high-sensitivity TnT assays were performed on postoperative days 0, 1, 2, and 3. Among orthopaedic patients, we determined (1) the prognostic relevance of the MINS diagnostic criteria, (2) the 30-day mortality rate for those with and without MINS, and (3) the probable proportion of MINS cases that would go undetected without troponin monitoring because of a lack of an ischemic symptom. RESULTS: Three hundred and sixty-seven orthopaedic patients (11.9%) had MINS. MINS was associated independently with 30-day mortality including among those who had had orthopaedic surgery. Orthopaedic patients without and with MINS had a 30-day mortality rate of 1.0% and 9.8%, respectively (odds ratio [OR], 11.28; 95% confidence interval [CI], 6.72 to 18.92). The 30-day mortality rate was increased for patients with MINS who had an ischemic feature (i.e., symptoms, or evidence of ischemia on electrocardiography or imaging) (OR, 18.25; 95% CI, 10.06 to 33.10) and for those who did not have an ischemic feature (OR, 7.35; 95% CI, 3.37 to 16.01). The proportion of orthopaedic patients with MINS who were asymptomatic and in whom the myocardial injury would have probably gone undetected without TnT monitoring was 81.3% (95% CI, 76.3% to 85.4%). CONCLUSIONS: One in 8 orthopaedic patients in our study had MINS, and MINS was associated with a higher mortality rate regardless of symptoms. Troponin levels should be measured after surgery in at-risk patients because most MINS cases (>80%) are asymptomatic and would go undetected without routine measurements. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
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Enfermedades Cardiovasculares/epidemiología , Procedimientos Ortopédicos , Complicaciones Posoperatorias/epidemiología , Anciano , Biomarcadores/sangre , Enfermedades Cardiovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Procedimientos Ortopédicos/mortalidad , Complicaciones Posoperatorias/mortalidad , Pronóstico , Estudios Prospectivos , Troponina T/sangreRESUMEN
BACKGROUND: The authors previously reported that perioperative aspirin and/or clonidine does not prevent a composite of death or myocardial infarction 30 days after noncardiac surgery. Moreover, aspirin increased the risk of major bleeding and clonidine caused hypotension and bradycardia. Whether these complications produce harm at 1 yr remains unknown. METHODS: The authors randomized 10,010 patients with or at risk of atherosclerosis and scheduled for noncardiac surgery in a 1:1:1:1 ratio to clonidine/aspirin, clonidine/aspirin placebo, clonidine placebo/aspirin, or clonidine placebo/aspirin placebo. Patients started taking aspirin or placebo just before surgery; those not previously taking aspirin continued daily for 30 days, and those taking aspirin previously continued for 7 days. Patients were also randomly assigned to receive clonidine or placebo just before surgery, with the study drug continued for 72 h. RESULTS: Neither aspirin nor clonidine had a significant effect on the primary 1-yr outcome, a composite of death or nonfatal myocardial infarction, with a 1-yr hazard ratio for aspirin of 1.00 (95% CI, 0.89 to 1.12; P = 0.948; 586 patients [11.8%] vs. 589 patients [11.8%]) and a hazard ratio for clonidine of 1.07 (95% CI, 0.96 to 1.20; P = 0.218; 608 patients [12.1%] vs. 567 patients [11.3%]), with effect on death or nonfatal infarction. Reduction in death and nonfatal myocardial infarction from aspirin in patients who previously had percutaneous coronary intervention at 30 days persisted at 1 yr. Specifically, the hazard ratio was 0.58 (95% CI, 0.35 to 0.95) in those with previous percutaneous coronary intervention and 1.03 (95% CI, 0.91to 1.16) in those without (interaction P = 0.033). There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1). CONCLUSIONS: Neither perioperative aspirin nor clonidine have significant long-term effects after noncardiac surgery. Perioperative aspirin in patients with previous percutaneous coronary intervention showed persistent benefit at 1 yr, a plausible sub-group effect.
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Analgésicos/administración & dosificación , Antiinflamatorios no Esteroideos/administración & dosificación , Aspirina/administración & dosificación , Clonidina/administración & dosificación , Atención Perioperativa/métodos , Complicaciones Posoperatorias/diagnóstico , Anciano , Analgésicos/efectos adversos , Antiinflamatorios no Esteroideos/efectos adversos , Aspirina/efectos adversos , Clonidina/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Internacionalidad , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/epidemiología , Infarto del Miocardio/prevención & control , Atención Perioperativa/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Factores de TiempoRESUMEN
Following publication of the original article [1], the authors notified us of a few requested editions that were not implemented adequately during proofing. The publisher apologizes for the inconvenience caused to our authors and readers.
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Resumen Introducción: la hipertensión arterial es responsable de gran parte de la carga de enfermedad cardiovascular; sin embargo, el papel del sueño en su etiología aun es controversial. Objetivo: determinar la asociación entre atributos del sueño y cambio de la presión arterial. Métodos: estudio de cohorte prospectiva, de base comunitaria, en adultos jóvenes asintomáticos para enfermedad cardiovascular, seguidos por 12,4 años. En la línea de base se determinaron factores sociodemográficos y del comportamiento, y se caracterizó el sueño nocturno usual en términos de calidad, duración y presencia de ronquido. Se realizó medición estandarizada de índices antropométricos y presión arterial. La hipertensión arterial se definió como reporte de tratamiento antihipertensivo o cifras de presión arterial ≥140/90 mm Hg. Resultados: se evaluaron de manera prospectiva 1.032 participantes (media de edad: 36,8 años, 64% hombres; en la línea de base). La incidencia de hipertensión arterial fue de 15,1% (IC95%: 12,8 - 17,4), con evidencia de mayor riesgo en los roncadores, atenuado posteriormente al ajuste por adiposidad (p>0,05). Se observó un gradiente entre la duración del sueño y el cambio en la presión arterial sistólica/diastólica (2,2/1,3 mm Hg en quienes reportaron 6-8 horas/día y 2,7/1,6 mm Hg en quienes reportaron > 8 horas/día, respecto a < 6 horas/día). Ni la calidad subjetiva del sueño ni el reporte de siesta se asociaron con la presión arterial. Conclusión: los resultados sugieren que la duración prolongada del sueño podría incrementar la presión arterial en la población.
Abstract Introduction: Arterial hypertension is responsible for large part of the cardiovascular disease load. However, the role of sleep in its aetiology remains controversial. Objective: To determine the relationship between sleep attributes and the change in blood pressure. Methods: A prospective cohort study was carried out on a community basis in young adults asymptomatic for cardiovascular disease, followed up for 12.4 years. At baseline, sociodemographic and behavioural factors were determined. At the same, time nocturnal sleep was characterised in terms of quality, duration and presence of snoring. Standardised anthropometric indices and blood pressure were measured. Arterial hypertension was defined as a report of anti-hypertension treatment or blood pressure figures ≥140/90 mm Hg. Results: A total of 1,032 participants were prospectively evaluated (mean age 36.8 years, 64% males; at baseline). The incidence of arterial hypertension was 15.1% (95% CI: 12.8 - 17. 4), with evidence of a higher risk in snorers, with a subsequent reduction on adjusting for adiposity (P>.05). A gradient was observed between the duration of sleep and the change in systolic/diastolic arterial pressure (2.2/1.3 mmHg in those who reported 6-8 hours/day, and 2.7/1.6 mmHg in those who reported > 8 hours/day, compared to < 6 horas/day). Neither the subjective quality of the sleep nor the report of a siesta was associated with the blood pressure. Conclusion: The results suggest that the prolonged duration of sleep could increase blood pressure in the population.
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Humanos , Masculino , Adulto , Sueño , Presión Arterial , Estudios de Cohortes , Colombia , HipertensiónRESUMEN
BACKGROUND: Either benznidazole (BZN) or nifurtimox (NFX) is recommended as equivalent to treat Trypanosoma cruzi infection. Nonetheless, supportive data from randomised trials is limited to individuals treated with BZN in southern cone countries of Latin America. METHODS: The goal of this randomised, concealed, blind, parallel-group trial is to inform the trypanocidal efficacy and safety of NFX and its equivalence to BZN among individuals with T. cruzi positive serology (TC+). Eligible individuals are TC+, 20-65 years old, with no apparent symptoms/signs or uncontrolled risk factors for cardiomyopathy and at negligible risk of re-infection. Consenting individuals (adherent to a 10-day placebo run-in phase) receive a 120-day BID blinded treatment with NFX, BZN or matching placebo (2:2:1 ratio). The four active medication arms include (1) a randomly allocated sequence of 60-day, conventional-dose (60CD) regimes (BZN 300 mg/day or NFX 480 mg/day, ratio 1:1), followed or preceded by a 60-day placebo treatment, or (2) 120-day half-dose (120HD) regimes (BZN 150 mg/day or NFX 240 mg/day, ratio 1:1). The primary efficacy outcome is the proportion of participants testing positive at least once for up to three polymerase chain reaction (PCR) assays (1 + PCR) 12-18 months after randomisation. A composite safety outcome includes moderate to severe adverse reactions, consistent blood marker abnormalities or treatment abandons. The trial outside Colombia (expected to recruit at least 60% of participants) is pragmatic; it may be open-label and not include all treatment groups, but it must adhere to the randomisation and data administration system and guarantee a blinded efficacy outcome evaluation. Our main comparisons include NFX groups with placebo (for superiority), NFX versus BZN groups and 60CD versus 120HD groups (for non-inferiority) and testing for the agent-dose and group-region interactions. Assuming a 1 + PCR ≥ 75% in the placebo group, up to 25% among BZN-treated and an absolute difference of up to ≥ 25% with NFX to claim its trypanocidal effect, 60-80 participants per group (at least 300 from Colombia) are needed to test our hypotheses (80-90% power; one-sided alpha level 1%). DISCUSSION: The EQUITY trial will inform the trypanocidal effect and equivalence of nitroderivative agents NFX and BZN, particularly outside southern cone countries. Its results may challenge current recommendations and inform choices for these agents. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02369978 . Registered on 24 February 2015.
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Enfermedad de Chagas/tratamiento farmacológico , Nifurtimox/uso terapéutico , Nitroimidazoles/uso terapéutico , Tripanocidas/uso terapéutico , Trypanosoma cruzi/efectos de los fármacos , Adulto , Anciano , Enfermedades Asintomáticas , Enfermedad de Chagas/diagnóstico , Enfermedad de Chagas/parasitología , Colombia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Nifurtimox/efectos adversos , Nitroimidazoles/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Equivalencia Terapéutica , Factores de Tiempo , Resultado del Tratamiento , Tripanocidas/efectos adversos , Trypanosoma cruzi/patogenicidad , Adulto JovenRESUMEN
BACKGROUND: Among adults undergoing contemporary noncardiac surgery, little is known about the frequency and timing of death and the associations between perioperative complications and mortality. We aimed to establish the frequency and timing of death and its association with perioperative complications. METHODS: We conducted a prospective cohort study of patients aged 45 years and older who underwent inpatient noncardiac surgery at 28 centres in 14 countries. We monitored patients for complications until 30 days after surgery and determined the relation between these complications and 30-day mortality using a Cox proportional hazards model. RESULTS: We included 40 004 patients. Of those, 715 patients (1.8%) died within 30 days of surgery. Five deaths (0.7%) occurred in the operating room, 500 deaths (69.9%) occurred after surgery during the index admission to hospital and 210 deaths (29.4%) occurred after discharge from the hospital. Eight complications were independently associated with 30-day mortality. The 3 complications with the largest attributable fractions (AF; i.e., potential proportion of deaths attributable to these complications) were major bleeding (6238 patients, 15.6%; adjusted hazard ratio [HR] 2.6, 95% confidence interval [CI] 2.2-3.1; AF 17.0%); myocardial injury after noncardiac surgery [MINS] (5191 patients, 13.0%; adjusted HR 2.2, 95% CI 1.9-2.6; AF 15.9%); and sepsis (1783 patients, 4.5%; adjusted HR 5.6, 95% CI 4.6-6.8; AF 12.0%). INTERPRETATION: Among adults undergoing noncardiac surgery, 99.3% of deaths occurred after the procedure and 44.9% of deaths were associated with 3 complications: major bleeding, MINS and sepsis. Given these findings, focusing on the prevention, early identification and management of these 3 complications holds promise for reducing perioperative mortality. Study registration: ClinicalTrials.gov, no. NCT00512109.