Impact of hydrocolloid dressings in the prevention of pressure ulcers in high-risk patients: a randomized controlled trial (PENFUP).

It is uncertain whether hydrocolloid dressings, a more costly intervention than offering standard care with petrolatum, is superior to prevent pressure ulcers among hospitalized high-risk adults. Randomized, parallel-group, open-label, superiority trial with an active control group, blinded for investigators, event validators, and analysts (December 1, 2015 to December 12, 2017). Eligible patients were ≥ 18 years of age with intact skin judged as high-risk for skin ulcers (Braden scale), admitted to surgical or medical wards of two tertiary-level hospitals. Participants were randomized (1:1) to protection with hydrocolloid dressings or petrolatum. The primary outcome was the first occurrence of pressure ulcers (with post-injury photographs adjudicated by three judges) under intention-to-treat analysis. Based on prior cost analysis, and the available resources (assumed incidence of 6 ulcers/1000 patient-days in controls), inclusion of up to 1500 participants allowed to surpass a one-sided superiority threshold > 5% based on a target efficacy > 40% for dressings. We planned an economic analysis using a decision tree model based on the effectiveness of the study results from a perspective of the third payer of health care. After inclusion of 689 patients (69 events), the trial was stopped for futility after a planned interim analysis (conditional power < 0.1 for all scenarios if the trial was completed). Pressure ulcers had occurred in 34 (10.2%) patients in the intervention group [9.6 per 1000 patient-days] and 35 (9.9%) participants in the control group [7.9 per 1000 patient-days], HR = 1.07 [95% CI 0.67 to 1.71]. The estimated incremental cost for dressings (a dominated strategy) was USD 52.11 per patient. Using hydrocolloid dressings was found similar to petrolatum for preventing pressure ulcers among hospitalized high-risk patients. As it conveys additional costs, and in this study was unlikely to demonstrate enough superiority, this strategy did not overcome conventional skin care.Trial registration: ClinicalTrials.gov identifier (NCT number): NCT02565745 registered on December 1, 2015.

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".

Postoperative atrial fibrillation: evaluation of its economic impact on the costs of cardiac surgery

Abstract Objective: The objective of this study was to calculate the direct costs of postoperative atrial fibrillation (POAF) in a high-complexity cardiovascular hospital. Methods: We performed a cost analysis with a pairwise-matched design. Twenty-two patients with POAF and 22 patients without this complication were included. Pair-matching was performed (1:1) based on the following criteria: identical type of surgery, similar EuroSCORE II values, and absence of any other postoperative complication. Results: The total hospital cost was significantly higher in the POAF group than in the non-POAF group (US$ 10,880 [± 2,688] vs. US$ 8,856 [± 1,782], respectively, for each patient; P=0.005). This difference was attributable to postoperative costs (US$ 3,103 [± 1,552] vs. US$ 1,238 [± 429]; P=0.0001) for patients with or without POAF, respectively. The median postoperative lengths of stay were 9 (range 5-17) and 5 (3-9) days for patients with and without POAF (P=0.032), respectively. Preoperatively, no differences were found in the EuroSCORE II values (median 1.7 vs. 1.6, respectively; P=0.91) or direct costs (US$ 1,127 vs. US$ 1,063, respectively; P=0.56) between POAF and non-POAF groups. Conclusion: POAF generates a high economic burden in the overall costs of cardiac surgery, and our results reveal the differential contribution of each of the evaluated factors. This information, which was previously unavailable in this setting, is essential for the development of more effective prevention strategies.

Postoperative Atrial Fibrillation: Evaluation of its Economic Impact on the Costs of Cardiac Surgery.

OBJECTIVE: The objective of this study was to calculate the direct costs of postoperative atrial fibrillation (POAF) in a high-complexity cardiovascular hospital. METHODS: We performed a cost analysis with a pairwise-matched design. Twenty-two patients with POAF and 22 patients without this complication were included. Pair-matching was performed (1:1) based on the following criteria: identical type of surgery, similar EuroSCORE II values, and absence of any other postoperative complication. RESULTS: The total hospital cost was significantly higher in the POAF group than in the non-POAF group (US$ 10,880 [± 2,688] vs. US$ 8,856 [± 1,782], respectively, for each patient; P=0.005). This difference was attributable to postoperative costs (US$ 3,103 [± 1,552] vs. US$ 1,238 [± 429]; P=0.0001) for patients with or without POAF, respectively. The median postoperative lengths of stay were 9 (range 5-17) and 5 (3-9) days for patients with and without POAF (P=0.032), respectively. Preoperatively, no differences were found in the EuroSCORE II values (median 1.7 vs. 1.6, respectively; P=0.91) or direct costs (US$ 1,127 vs. US$ 1,063, respectively; P=0.56) between POAF and non-POAF groups. CONCLUSION: POAF generates a high economic burden in the overall costs of cardiac surgery, and our results reveal the differential contribution of each of the evaluated factors. This information, which was previously unavailable in this setting, is essential for the development of more effective prevention strategies.

Factors associated with delayed cardiac tamponade after cardiac surgery.

CONTEXT: Cardiac tamponade (CT) following cardiac surgery is a potentially fatal complication and the cause of surgical reintervention in 0.1%-6% of cases. There are two types of CT: acute, occurring within the first 48 h postoperatively, and subacute or delayed, which occurs more than 48 h postoperatively. The latter does not show specific clinical signs, which makes it more difficult to diagnose. The factors associated with acute CT (aCT) are related to coagulopathy or surgical bleeding, while the variables associated with subacute tamponade have not been well defined. AIMS: The primary objective of this study was to identify the factors associated with the development of subacute CT (sCT). SETTINGS AND DESIGN: This report describes a case (n = 80) and control (n = 160) study nested in a historic cohort made up of adult patients who underwent any type of urgent or elective cardiac surgery in a tertiary cardiovascular hospital. Methods: The occurrence of sCT was defined as the presence of a compatible clinical picture, pericardial effusion and confirmation of cardiac tamponade during the required emergency intervention at any point between 48 hours and 30 days after surgery. All factors potentially related to the development of sCT were taken into account. STATISTICAL ANALYSIS USED: For the adjusted analysis, a logistical regression was constructed with 55 variables, including pre-, intra-, and post-operative data. RESULTS: The mortality of patients with sCT was 11% versus 0% in the controls. Five variables were identified as independently and significantly associated with the outcome: pre- or post-operative anticoagulation, reintervention in the first 48 h, surgery other than coronary artery bypass graft, and red blood cell transfusion. CONCLUSIONS: Our study identified five variables associated with sCT and established that this complication has a high mortality rate. These findings may allow the implementation of standardized follow-up measures for patients identified as higher risk, leading to either early detection or prevention.

Tuberculosis pulmonar, esofágica y laríngea / Pulmonary, esophageal and laryngeal tuberculosis

Resumen La tuberculosis es una de las enfermedades que más ha impactado en la sociedad a nivel mundial siendo influenciada por la pandemia del VIH, los patrones migratorios y el uso de la medicación antituberculosa. La forma extrapulmonar es rara siendo más característica en los pacientes inmunocomprometidos, cuyas manifestaciones clínicas son inespecíficas, por lo que constituye un reto diagnósticopara los clínicos, en la mayoría de los casos retardando su detección y tratamiento. Se presenta el caso clínico de un paciente aparentemente inmunocompetente que consulta por cuadro de seis años de evolución de disfagia progresiva, pérdida de peso inexplicada, en quien se encontró compromiso por tuberculosis a nivel esofágico y laríngeo que explicaban los síntomas de ingreso, así como compromiso pulmonar sin clara sintomatología. Cuadro llamativo y de relevancia por su forma de presentación de alto riesgo de diseminación de la infección en un paciente sin inmunocompromiso. (Acta Med Colomb 2014; 39: 85-89).

Abstract Tuberculosis is one of the diseases that has more impacted the global society, being influenced by the HIV pandemic, migration patterns and the use of anti-TB drugs. Extrapulmonary tuberculosis is rare, being more characteristic in immunocompromised patients, whose clinical manifestations are nonspecific, thus constituting a diagnostic challenge for clinicians and in most cases delaying its detection and treatment. The case of a patient apparently immunocompetent consulting for a six years history of progressive dysphagia and unexplained weight loss, in whom involvement of esophagus and larynx by tuberculosis was found explaining the symptoms of admission, as well as the pulmonary involvement with no clear symptoms, is presented. It is a striking and relevant clinical picture by its presentation with high risk of dissemination of the infection in a patient without immunocompromise. (Acta Med Colomb 2014; 39: 85-89).

Costos ambulatorios y hospitalarios de la falla cardiaca en dos hospitales de Bogotá / Outpatient and inpatient costs of heart failure in two hospitals in Bogotá

Objetivo: realizar una aproximación a la determinación de costos directos de la falla cardiaca (FC) en el país, a través de la evaluación de costos asociados con el cuidado de pacientes atendidos en dos instituciones prestadoras de salud de Bogotá. Métodos: estudio de costos bajo la perspectiva del tercer pagador. La identificación de eventos generadores de costos en atención ambulatoria se realizó mediante revisión de historias clínicas de pacientes atendidos durante 2011 en la consulta externa especializada de una institución. Los costos de interconsultas y paraclínicos se determinaron según los valores del Acuerdo 256 de 2001, con adición de 30%. Los costos de la medicación se determinaron a partir del registro SISMED. La identificación de eventos generadores de costos en hospitalización se realizó mediante revisión de listados y facturas de pacientes atendidos entre 2009 y 2010 en dos instituciones. Los resultados se presentan resumidos por medidas de tendencia central y de dispersión, en pesos colombianos (COP) de 2011. Resultados: el costo mensual promedio del tratamiento ambulatorio de FC fue de 304.318 COP (D.E. 760.876), con una mediana de 45.280 COP (RIC 25.539 - 109.715); los medicamentos representaron la fuente principal de consumo de recursos (55,2%). El costo promedio de la hospitalización por descompensación de FC fue de 6.427.887 COP (D.E. 9.663.176); la estancia hospitalaria representó la mayor proporción del costo (29,1%). Conclusiones: los costos ambulatorios, y especialmente los hospitalarios, asociados con la FC en Colombia son sustanciales. La fuente principal de costos difiere dependiendo de si el manejo es hospitalario (estancia) o ambulatorio (medicamentos). (Acta Med Colomb 2013; 38: 208-212).

Objective: to make an approach to the determination of direct costs of heart failure (HF) in the country through the evaluation of costs associated with the care of patients seen in two health institutions in Bogota. Methods: low cost third-party payer perspective. Identification of cost generating events in ambulatory care was performed by review of medical records of patients seen during 2011 in the specialized outpatient clinic of an institution. Interconsultations and paraclinical costs were determined according to the 256 Agreement of 2001, with addition of 30%. Medication costs were determined from the SISMED register. Identification of events that generate costs in hospitalization was conducted by reviewing lists and bills of patients treated between 2009 and 2010 in two institutions. The results are presented summarized by measures of central tendency and dispersion, in Colombian pesos (COP) of 2011. Results: the average monthly cost for outpatient treatment of HF was 304,318 COP (D.E. 760 876), with a median of 45,280 COP (RIC 25,539-109,715); drugs represented the main source of resource consumption (55.2%). The average cost of hospitalization for decompensated HF was 6,427,887 COP (D.E. 9.663.176); hospital stay accounted for the largest proportion of the cost (29.1%). Conclusions: outpatient costs, and especially the inpatient ones associated with HF in Colombia are substantial. The main source of costs differs depending on whether the management is hospitable (stay) or outpatient (drugs). (Acta Med Colomb 2013; 38: 208-212).

[Reference values for respiratory parameters in the adult population of Bogotá, D.C., Colombia]. / Valores de referencia para parámetros de espirometría en la población adulta residente en Bogotá, D. C., Colombia.

INTRODUCTION: Reference values for pulmonary function parameters, generally applicable to most populations, have shown little validity in the correct interpretation of pulmonary function tests when applied to the adult population in Bogotá. OBJECTIVE: To identify which of four prediction models generated for use in populations of a similar ethnic background to that found in Colombia is the most accurate for use in adults in Bogotá. MATERIALS AND METHODS: 534 subjects (male and female) between 18 and 65 years of age were recruited from a pool of workers employed by three private Bogotá companies. All subjects had resided in Bogotá for at least five years before the initiation of the study. Smokers and those with altered pulmonary function were excluded. Pulmonary function parameters were measured by flow volume curve. The results were analyzed (specifically, the difference between predicted and observed values) and the limits were calculated using the Bland & Altman method. A maximum average prediction error of 5% was accepted as valid for the observed value of each parameter. RESULTS: The models shown to be valid were as follows: Crapo for forced vital capacity (FVC) in men; Pérez-Padilla for FVC in women and for the ratio forced expiratory volume in the first second (FEV1/FVC) in both sexes, and the Hankinson model for Mexican-Americans, for all parameters in both sexes. CONCLUSIONS: The Hankinson model proved to be the most accurate in predicting all spirometry parameters. However, its poor classification average (7%) is a limitation. In the future, new models with a better predictive accuracy will be required.

Valores de referencia para parámetros de espirometría en la población adulta residente en Bogotá, D. C., Colombia / Reference values for respiratory parameters in the adult population of Bogotá, D.C., Colombia

Introducción. Los valores de referencia para parámetros de la función pulmonar aplicables a otras poblaciones, han mostrado ser poco válidos en la interpretación de las pruebas de función pulmonar en la población adulta residente en Bogotá. Objetivo. Identificar cuál de cuatro modelos de predicción generados en poblaciones con características étnicas similares a la población colombiana, es el más adecuado para utilizar en adultos de Bogotá. Materiales y métodos. Se reclutaron 534 sujetos de ambos sexos entre los 18 y los 65 años de edad, no fumadores, libres de alteraciones pulmonares, trabajadores de tres empresas privadas y residentes en Bogotá por más de cinco años. La función pulmonar se midió por curva de flujo volumen. Se estimaron las diferencias observadas entre valores predichos y observados, y se calcularon los límites por el método de Bland y Altman. Se aceptaron como válidos los modelos que presentaron un error de predicción promedio máximo de 5% del valor observado en cada parámetro.Resultados. Demostraron ser válidos en esta población los modelos: Crapo para capacidad vital forzada (CVF) en hombres; Pérez-Padilla, para CVF en mujeres y para la relación con el volumen espiratorio forzado en el primer segundo (VEF1/CVF) en ambos grupos y los de Hankinson para mexicano-americanos para todos los parámetros en ambos sexos.Conclusiones. Los modelos de Hankinson demostraron ser los más adecuados para predecir todos los parámetros de la espirometría; sin embargo, dejan un porcentaje de mala clasificación promedio de 7%. Se requiere generar modelos propios con mayor precisión pronóstica en la población de Bogotá.

Introduction. Reference values for pulmonary function parameters, generally applicable to most populations, have shown little validity in the correct interpretation of pulmonary function tests when applied to the adult population in Bogotá. Objective. To identify which of four prediction models generated for use in populations of a similar ethnic background to that found in Colombia is the most accurate for use in adults in Bogotá. Materials and methods. 534 subjects (male and female) between 18 and 65 years of age were recruited from a pool of workers employed by three private Bogotá companies. All subjects had resided in Bogotá for at least five years before the initiation of the study. Smokers and those with altered pulmonary function were excluded. Pulmonary function parameters were measured by flow volume curve. The results were analyzed (specifically, the difference between predicted and observed values) and the limits were calculated using the Bland & Altman method. A maximum average prediction error of 5% was accepted as valid for the observed value of each parameter.Results. The models shown to be valid were as follows: Crapo for forced vital capacity (FVC) in men; Pérez-Padilla for FVC in women and for the ratio forced expiratory volume in the first second (FEV1/FVC) in both sexes, and the Hankinson model for Mexican-Americans, for all parameters in both sexes. Conclusions. The Hankinson model proved to be the most accurate in predicting all spirometry parameters. However, its poor classification average (7%) is a limitation. In the future, new models with a better predictive accuracy will be required.

Diabetes mellitus tipo 2 y deterioro de la función pulmonar / Diabetes mellitus type 2 and deterioration of pulmonary function

Introducción: un aspecto poco estudiado de la diabetes mellitus tipo 2 (DM 2), es su posible asociación con alteraciones de la función pulmonar. Estudios recientes han mostrado niveles mayores de marcadores de inflamación sistémica de bajo nivel en pacientes con DM 2, lo que también podría afectar la función pulmonar. El objetivo de este estudio fue determinar si la función pulmonar de personas con DM 2 es diferente de la función pulmonar de un grupo control sin DM.Población y método: se realizó un estudio observacional transversal, comunitario, en diabéticos y en controles sanos, apareados por estratos de edad y sexo. Los controles fueron vecinos de cada diabético, del mismo sexo y grupo de edad, sin DM. La muestra de diabéticos se seleccionó de la población de pacientes que consultan a la Asociación Colombiana de Diabetes (ACD) en Bogotá. Se comprobó el estatus de diabético y de control sano mediante las pruebas de glucemia en ayunas y glucemia poscarga de glucosa. Se realizaron curvas de flujo volumen tanto para los diabéticos como para los controles, y de acuerdo con los valores de referencia obtenido por Hankinson para mexicoamericanos se obtuvieron valores residuales promedios (observado – esperado) para VEF1, CVF y relación VEF1/CVF. Mediante regresión lineal múltiple se ajustó por diferencias en determinantes conocidos de la función pulmonar (edad, sexo, talla, tabaquismo, exposición a humo de leña)...

Curso clínico y supervivencia en embolia pulmonar. Resultados del registro multicéntrico colombiano (EMEPCO) / Clinical course and survival in pulmonary embolism. Results of the Colombian multicentric registry (EMEPCO)

Introducción: la embolia pulmonar (EP) se asocia con morbilidad y mortalidad sustanciales, sin embargo existe muy poca información proveniente de países latinoamericanos. Los objetivos de este estudio fueron el describir el curso clínico y la supervivencia de una cohorte con EP, e identificar factores asociados con la mortalidad hospitalaria.Pacientes y método: estudio de cohorte en instituciones de cuatro ciudades colombianas. Pacientes adultos con EP por criterios previamente establecidos, fueron invitados a participar. La información sobre factores de riesgo, cuadro clínico, exámenes, tratamientos, y estado vital al alta hospitalaria y hasta por 12 meses, fue recogida sistemáticamente por personal entrenado.Resultados: el total de pacientes incluidos fue 251, con edad promedio de 65 años (DE 18); 66 porciento fueron mujeres. La frecuencia de trombo-profilaxis fue 22 porciento. La mortalidad hospitalaria fue 14.8 porciento (IC95 porciento: 11 – 19 porciento). Factores asociados con mortalidad hospitalaria incluyeron hipotensión (RR: 2.57; IC95 porciento: 1.4 – 4.73) y fractura de cadera (RR: 2.55; IC95 porciento: 1.34-4.83). La supervivencia a las 52 semanas poshospitalización fue 85 porciento (IC95 porciento: 79-90 porciento).Conclusiones: en esta cohorte colombiana, la EP estuvo asociada con mortalidad sustancial temprana y tardía. La mayor mortalidad en pacientes con fractura de cadera refuerza la necesidad de uso rutinario de estrategias de tromboprofilaxis efectivas y seguras.