Declaración sobre los sistemas electrónicos de administración de nicotina (SEAN), similares e imitadores / Statement on electronic nicotine delivery systems, look-alikes and imitators

Colombia está mostrando los resultados de la falta de regulación, fácil acceso y ausencia de campañas promocionales de los cigarrillos electrónicos, a tal punto que en Bogotá el 37.8 % de los universitarios ha probado algún tipo de dispositivo, demostrando que puede ser la puerta de entrada al consumo y aumenta el consumo de tabaco a nivel poblacional (1). Nuestro país hace parte del Convenio Marco para el Control del Tabaco de la OMS (2), que está reglamentado con la Ley 1335 de 2009 y continua vigente. Manifestamos nuestra preocupación por la cercanía de la industria tabacalera a los profesionales de la salud, la cual estimula el tema del abordaje al consumo de tabaco y temas como reducción del daño, promoviendo de alguna manera los productos de tabaco calentado o similares, lo cual va en contra de lo reglamentado por la Ley 1335 de 2009, norma que prohíbe todas formas de promoción de productos de tabaco y sus derivados en sus artículos 16 y 17 (3). Es de anotar que se desconoce la seguridad de estos dispositivos a largo plazo, por la ausencia de estudios de seguimiento.

Strategies to improve cost effectiveness of robotic assisted laparoscopic radical prostatectomy in emerging economies.

To assess the cost-effectiveness of the robotic-assisted laparoscopic radical prostatectomy (RALRP) compared to open radical prostatectomy (ORP) for localized prostate cancer from a healthcare perspective in Colombia. A systematic review was conducted in Embase, Scopus, Web of Science, PubMed, and Cochrane CENTRAL databases, to identify relevant publications up to January 2020 to summarize clinical outcomes related to effectiveness of robot-assisted and open radical prostatectomy. A tree decision model was designed given the clinical outcomes and possibilities of complication and success. Outcomes were defined as complications according to Clavien - Dindo classification and success measured as urethral stricture rate. Cost was divided into two categories: surgical procedure and complications. Incremental cost-effectiveness ratio (ICER) was calculated and a deterministic sensitivity analysis was performed to evaluate the impact of the uncertainty on the conclusions of the model. A 90-day horizon was defined. Direct medical costs associated with RALRP were $6.511 ($ 5.127- $8.138), and for ORP were $4.476 ($2.170-$ 6.511). The average cost for complication management was rated at $ 327 for RALRP and $ 382 for ORP, based on an augmented risk of post-operative urethral stricture in the ORP group (2.4% vs 10.8%). ICER was calculated in USD $18.987. The cost of RALRP has to be reduced to around USD 5.345 to achieve an ICER under 1 GDP making the intervention feasible. Using a 3 GDP per capita threshold, the implementation of RALRP could be cost-effective for the treatment of localized prostate cancer in emerging economies. Bolder measures including the use of one needle carrier, three robotic arms, and a shorten hospitalization program of 24 h, can save around $1000 for each patient, achieving the goal cost of $5345 needed for a favorable ICER.

Oximetry and neonatal examination for the detection of critical congenital heart disease: a systematic review and meta-analysis.

Background: Undiagnosed congenital heart disease in the prenatal stage can occur in approximately 5 to 15 out of 1000 live births; more than a quarter of these will have critical congenital heart disease (CCHD). Late postnatal diagnosis is associated with a worse prognosis during childhood, and there is evidence that a standardized measurement of oxygen saturation in the newborn by cutaneous oximetry is an optimal method for the detection of CCHD. We conducted a systematic review of the literature and meta-analysis comparing the operational characteristics of oximetry and physical examination for the detection of CCHD. Methods: A systematic review of the literature was conducted on the following databases including published studies between 2002 and 2017, with no language restrictions: Pubmed, Science Direct, Ovid, Scopus and EBSCO, with the following keywords: oximetry screening, critical congenital heart disease, newborn OR oximetry screening heart defects, congenital, specificity, sensitivity, physical examination. Results: A total of 419 articles were found, from which 69 were selected based on their titles and abstracts. After quality assessment, five articles were chosen for extraction of data according to inclusion criteria; data were analyzed on a sample of 404,735 newborns in the five included studies. The following values were found, corresponding to the operational characteristics of oximetry in combination with the physical examination: sensitivity: 0.92 (CI 95%, 0.87-0.95), specificity: 0.98 (CI 95%, 0.89-1.00), for physical examination alone sensitivity: 0.53 (CI 95%, 0.28-0.78) and specificity: 0.99 (CI 95%, 0.97-1.00). Conclusions: Evidence found in different articles suggests that pulse oximetry in addition to neonatal physical examination presents optimal operative characteristics that make it an adequate screening test for detection of CCHD in newborns, above all this is essential in low and middle-income settings where technology medical support is not entirely available.

Cost-effectiveness analysis of newborn pulse oximetry screening to detect critical congenital heart disease in Colombia.

BACKGROUND: In many countries, economic assessments of the routine use of pulse oximetry in the detection of Critical Congenital Heart Disease (CCHD) at birth has not yet been carried out. CCHDs necessarily require medical intervention within the first months of life. This assessment is a priority in low and medium resource countries. The purpose of this study was to assess the cost-effectiveness (CE) relation of pulse oximetry in the detection of cases of CCHD in Colombia. METHODS: A full economic assessment of the cost-effectiveness type was conducted from the perspective of society. A decision tree was constructed to establish a comparison between newborn physical examination plus pulse oximetry, versus physical examination alone, in the diagnosis of CCHDs. The sensitivity and specificity of pulse oximetry were estimated from a systematic review of the literature; to assess resource use, micro-costing analyses and surveys were conducted. The time horizon of the economic evaluation was the first week after birth and until the first year of life. The incremental cost-effectiveness ratio (ICER) was determined and, to control for uncertainty, deterministic and probabilistic sensitivity analysis were made, including the adoption of different scenarios of budgetary impact. All costs are expressed in US dollars from 2017, using the average exchange rate for 2017 [$2,951.15 COP for 1 dollar]. RESULTS: The costs of pulse oximetry screening plus physical examination were $102; $7 higher than physical examination alone. The effectiveness of pulse oximetry plus the physical examination was 0.93; that is, 0.07 more than the physical examination on its own. The ICER was $100 for pulse oximetry screening; that is, if one wishes to increase 1% the probability of a correct CCHD diagnosis, this amount would have to be invested. A willingness to pay of $26.292 USD (direct medical cost) per probability of a correct CCHD diagnosis was assumed. CONCLUSIONS: At current rates and from the perspective of society, newborn pulse oximetry screening at 24 h in addition to physical examination, and considering a time horizon of 1 week, is a cost-effective strategy in the early diagnosis of CCHDs in Colombia.Trial registration "retrospectively registered".

Photovaporization of the prostate with GreenLight™ laser 180 W XPS versus transurethral resection of the prostate with monopolar energy for the treatment of benign prostatic enlargement: a cost-utility analysis from a healthcare perspective.

PURPOSE: To assess the cost-utility of the photovaporization of the prostate (PVP) with GreenLight™ laser 180 W XPS compared to transurethral resection of the prostate with monopolar energy (M-TURP) for lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) from a healthcare perspective in Colombia. METHODS: We designed a Markov model to compare four health states following treatment with either PVP or M-TURP to estimate expected costs and outcomes. We used the results of the only randomized clinical trial published to date comparing PVP versus M-TURP to estimate surgical outcomes, complications, re-operation and re-intervention rates. Time horizon was defined at 2 years with four cycles of 6 months each. Resource-use estimation involved a random selection of clinical records from a local institution and cost list from public healthcare system. Costs were obtained in Colombian pesos and converted to US dollars. Threshold was defined at three-times the Colombian gross domestic product (GDP) per capita. Quality-adjusted-life-years (QALYs) were used based on the utilities of the available literature. Uncertainty was analyzed with deterministic and probabilistic models using a Monte Carlo simulation. RESULTS: Patients who underwent PVP gained 1.81 QALYs compared to 1.59 with M-TURP. Costs were US$6797.98 and US$7777.59 for M-TURP and PVP, respectively. Incremental cost-effectiveness ratio was US$4452.81 per QALY, favoring PVP as a cost-effective alternative in our context. CONCLUSIONS: In Colombia, with current prices, PVP is cost-effective when compared to M-TURP for LUTS due to BPE for a 2-year time horizon.

Corticosteroides orales o endovenosos en el manejo de la crisis asmática moderada o severa?: implicaciones de costos y efectividad / Corticosteroids in the management of moderate or severe asthmatic crises: oral or intravenous?: implications concerning costs and effectiveness

Objetivo: determinar si los coticoesteroides orales son la vía más efectiva y menos costosa con respecto a los corticosteroides endovenosos para el manejo de la crisis asmática moderada o severa. Diseño: usando un análisis de decisiones, se realizó un estudio de minimización de costos. Material y métodos: el estudio se realizó en el Hospital Universitario de San Ignacio de Bogotá, Colombia, institución privada de tercer nivel. La determinación de los costos y de los recursos usados, se realizó revisando historias clínicas de pacientes con asma que fueron atendidos entre 1988 y 1997. Se realizó una proyección para 1.000 sujetos atendidos por dicho padecimiento. La determinación de la efectividad de los corticosteroides orales vs los endovenosos se basó en un meta-análisis. Resultados: los pacientes recibieron en promedio 4 días de corticosteroides endovenosos, lo que lleva a que el costo de la administración de este medicamento para 1.000 personas, sea de $ 148.404.000 y de $ 8.493.000 (5,7%) si se hubiera usado oral a dosis de 1 mg/kg/día de prednisolona o su equivalente. Simultáneamente en dos meta-análisis encontrados en la literatura se pudo demostrar que la actividad de los corticoesteroides usados por vía oral o por vía endovenosa es similar y que excepto exista una contraindicación para la vía oral, los efectos esperados en los pacientes van a ser similares. Conclusiones: dado que la eficacia de los corticosteroides orales es semejante a la de los corticosteroides endovensos en el manejo de la crisis asmática y que el costo de la terapia oral es mucho menor, se recomienda dar tratamiento a los pacientes con corticosteroides orales excepto cuando exista contraindicación para el uso de la vía oral.

Incidencia de sangrado digestivo en la UCI del Hospital Universitario San Ignacio / Incidence of digestive bleeding in ICU patients of San Ignacio University Hospital

Objetivos: calcular la incidencia de sangrado gastrointestinal significativo y no significativo en pacientes de la Unidad de Cuidado Intensivo del Hospital San Ignacio, admitidos entre agosto y noviembre de 2007 y la mortalidad relacionada con este.Diseño del estudio: estudio descriptivo de incidencia.Lugar del estudio: Unidad de Cuidado Intensivo del Hospital Universitario San Ignacio.Pacientes: mayores de 16 años que ingresan a la unidad de cuidado intensivo, con una estancia mayor de 24 horas y que no ingresen por hemorragia digestiva o hayan recibido tratamiento previo con cualquier tipo de inhibidor de bomba de protones, sucralfate, antiH2, o antiácido.Intervenciones: ninguna Mediciones: sangrado gastrointestinal significativo, sangrado gastrointestinal no significativo, muerte por sangrado gastrointestinal.Resultados: muestra recolectada de 524 sujetos. Promedio de edad 57 años (máx. 94-min 17 años), 236 mujeres y 285 hombres. Incidencia acumulada de sangrado gastrointestinal 3.44 por ciento. Incidencia de sangrado significativo 2.6 por ciento. Incidencia de sangrado no significativo 0.76 por ciento. Mortalidad global 9.34 por ciento, mortalidad por sangrado 0 por ciento.Conclusiones: la incidencia de sangrado gastrointestinal significativo se encuentra entre rangos mencionados en la literatura, algo inferior a algunos estudios, lo cual podría estar en relación con el alto porcentaje de profilaxis manejado. La incidencia de sangrado gastrointestinal no significativo es baja comparativamente con la mencionada en otros estudios; sin embargo, se encontraron deficiencias en el registro de datos en la historia clínica, y muchos pacientes recibieron profilaxis o tratamiento aún sin tener un alto riesgo o claro diagnóstico del origen del sangrado. La mortalidad global fue de 49 pacientes (9.35 por ciento), ninguna atribuible a sangrado gastrointestinal.