[Degree of satisfaction with the informed consent process and participation in clinical trials. A 3400 patients' study]. / Grado de satisfacción con el proceso de consentimiento informado y la participación en ensayos clínicos. Un estudio en 3400 pacientes.

The level of comprehension on the information provided in the process of the informed consent can provide a free and voluntary decision. The comprehension and satisfaction of the participants affect their adherence to clinical trials. The objective of the study was to analyze the level of satisfaction of the subjects with the informed consent process as well as with their participation in clinical trials. A total of 3115 out of 3404 surveys received were included, from 362 protocols (with a similar number of investigators), conducted in different Argentinian provinces. Overall, 91% of the people classified the received information as rather good or excellent, and 95% replied that all of their doubts were cleared up. In the surveys, 97% expressed their willingness to participate in future studies, and 98% would recommend participating in clinical trials to others. The satisfaction score with participation in the study was associated, independently of age and socioeconomic level, with the desire to participate in a clinical trial again (OR 13.6: 95% CI: 4.7-39.1, p < 0.001) and with the recommendation to participate given to others (OR 16.7: 95% CI: 4.4-63.4, p < 0.001). In this sample from Argentina, there was a high degree of satisfaction both with the process of obtaining informed consent and with participation in clinical trials, regardless of age and socioeconomic status.

El grado de comprensión de la información brindada en el proceso de consentimiento informado permite tomar una decisión libre y voluntaria. La comprensión y satisfacción de los participantes impactan sobre la adherencia a los ensayos clínicos. El objetivo de este estudio observacional fue analizar el grado de satisfacción de los sujetos con el proceso de consentimiento informado y con la participación en un ensayo clínico. Se incluyeron 3115 de 3404 encuestas recibidas, de 362 protocolos (y similar cantidad de investigadores) realizados en diversas provincias de la Argentina. El 91% de las personas clasificó la información recibida como muy buena o excelente y el 95% contestó que todas sus dudas fueron aclaradas. El 97% expresó su voluntad de volver a participar en estudios futuros y el 98% recomendaría a otras personas participar en ensayos clínicos. El puntaje de satisfacción con la participación en el estudio se asoció, en forma independiente de la edad y del nivel socioeconómico, con el deseo de volver a participar en un ensayo clínico (OR 13.6: IC95%: 4.7-39.1, p < 0.001) y con la recomendación a un tercero para que también participe (OR 16.7: IC95%: 4.4-63.4, p < 0.001). En esta muestra de la Argentina existe alto grado de satisfacción tanto con el proceso de toma de consentimiento informado como con la participación en los ensayos clínicos, en forma independiente de la edad y del nivel socioeconómico.

Grado de satisfacción con el proceso de consentimiento informado y la participación en ensayos clinicos. Un estudio en 3400 pacientes / Degree of satisfaction with the informed consent process and participation in clinical trials. A 3400 patients' study

Resumen El grado de comprensión de la información brindada en el proceso de consentimiento informado permite tomar una decisión libre y voluntaria. La comprensión y satisfacción de los participantes impactan sobre la adherencia a los ensayos clínicos. El objetivo de este estudio observacional fue analizar el grado de satisfacción de los sujetos con el proceso de consentimiento informado y con la participación en un ensayo clínico. Se incluyeron 3115 de 3404 encuestas recibidas, de 362 protocolos (y similar cantidad de in vestigadores) realizados en diversas provincias de la Argentina. El 91% de las personas clasificó la información recibida como muy buena o excelente y el 95% contestó que todas sus dudas fueron aclaradas. El 97% expresó su voluntad de volver a participar en estudios futuros y el 98% recomendaría a otras personas participar en ensayos clínicos. El puntaje de satisfacción con la participación en el estudio se asoció, en forma independiente de la edad y del nivel socioeconómico, con el deseo de volver a participar en un ensayo clínico (OR 13.6: IC95%: 4.7-39.1, p < 0.001) y con la recomendación a un tercero para que también participe (OR 16.7: IC95%: 4.4-63.4, p < 0.001). En esta muestra de la Argentina existe alto grado de satisfacción tanto con el proceso de toma de consentimiento informado como con la participación en los ensayos clínicos, en forma independiente de la edad y del nivel socioeconómico.

Abstract The level of comprehension on the information provided in the process of the informed consent can provide a free and voluntary decision. The comprehension and satisfaction of the participants affect their adherence to clinical trials. The objective of the study was to analyze the level of satisfaction of the subjects with the informed consent process as well as with their participation in clinical trials. A total of 3115 out of 3404 surveys received were included, from 362 protocols (with a similar number of investigators), conducted in different Argentinian provinces. Overall, 91% of the people classified the received information as rather good or excellent, and 95% replied that all of their doubts were cleared up. In the sur veys, 97% expressed their willingness to participate in future studies, and 98% would recommend participating in clinical trials to others. The satisfaction score with participation in the study was associated, independently of age and socioeconomic level, with the desire to participate in a clinical trial again (OR 13.6: 95% CI: 4.7- 39.1, p < 0.001) and with the recommendation to participate given to others (OR 16.7: 95% CI: 4.4-63.4, p < 0.001). In this sample from Argentina, there was a high degree of satisfaction both with the process of obtaining informed consent and with participation in clinical trials, regardless of age and socioeconomic status.

Impact of the International Nosocomial Infection Control Consortium (INICC) Multidimensional Hand Hygiene Approach During 3 Years in 6 Hospitals in 3 Mexican Cities.

OBJECTIVES: To evaluate the impact of the International Nosocomial Infection Control Consortium (INICC) multidimensional hand hygiene (HH) approach in Mexico, and analyze predictors of poor HH compliance. METHODS: From June 2002 to April 2006, we conducted a prospective, observational, before-and-after study in 8 intensive care units (ICUs) from 6 hospitals in 3 cities of Mexico. The approach included administrative support, availability of supplies, education and training, reminders in the workplace, process surveillance, and performance feedback. RESULTS: A total of 13,201 observations for HH opportunities were done in each ICU, during randomly selected 30-minute periods. Overall, HH compliance increased from 45% to 79% (95% confidence interval [CI], 69.1-86.5; P = 0.01). Univariate and multivariate analyses showed that several variables were significantly associated with poor HH compliance: males versus females (61% versus 66%; 95% CI, 0.91-0.96; P = 0.0001), physicians versus nurses (62% versus 67%; 95% CI, 0.91-0.97; P = 0.0001), and adult versus neonatal ICUs (67% versus 54%; 95% CI, 0.79-0.84; P = 0.0001), among others. CONCLUSIONS: Hand hygiene programs should focus on variables found to be predictors of poor HH compliance.

Nuevos métodos de valoración de la enfermedad pulmonar obstructiva crónica, su adecuación a la evaluación del menoscabo y la incapacidad / New evaluating methods of chronic obstructive pulmonary disease: adaptation for damage and incapacity evaluation

La enfermedad pulmonar obstructiva crónica es la patología crónica respiratoria más frecuente y que con más frecuencia puede producir incapacidad. La manera tradicional de evaluar la gravedad de la enfermedad es mediante la espirometría. Pero la presentación clínica de la enfermedad no es homogénea y se conoce que no hay una buena correlación entre los resultados de la espirometría y la situación clínica real del enfermo. En los últimos años se han desarrollado procedimientos para evaluar la enfermedad combinando varios parámetros, o sea haciendo una evaluación multidimensional. Esto consigue predecir mucho mejor el pronóstico y la gravedad de la patología. Los médicos que hacemos evaluación de la incapacidad debemos conocer y manejar estas herramientas para hacer nuestras valoraciones más precisas. Se presentan dos de estas herramientas la derivada de la Iniciativa GOLD y la desarrollada en España, la GesEPOC. Se explica su aplicación y su uso en la evaluación de la incapacidad

Chronic obstructive pulmonary disease is the most common chronic respiratory disease and the one that most often can lead to disability. Spirometry is the traditional way to assess the severity of the disease. But its clinical presentation is not homogeneous and it is known that there is no good correlation between spirometry results and the clinical situation of the patient. In recent years, evaluating methods for the disease have been developed by combining certain parameters, i.e. making a multidimensional assessment. This way, the prognosis and severity of the disease is much better predicted. Physicians like us, who do assessment of disability, must know and manage these tools to make our accurate assessments. Two of these tools are given, the derivative of the GOLD Initiative and the one developed in Spain, the GesEPOC. This application and its use is further explained in the evaluation of the disability

Effectiveness of a multidimensional approach for prevention of ventilator-associated pneumonia in adult intensive care units from 14 developing countries of four continents: findings of the International Nosocomial Infection Control Consortium.

OBJECTIVES: The aim of this study was to analyze the effect of the International Nosocomial Infection Control Consortium's multidimensional approach on the reduction of ventilator-associated pneumonia in patients hospitalized in intensive care units. DESIGN: A prospective active surveillance before-after study. The study was divided into two phases. During phase 1, the infection control team at each intensive care unit conducted active prospective surveillance of ventilator-associated pneumonia by applying the definitions of the Centers for Disease Control and Prevention National Health Safety Network, and the methodology of International Nosocomial Infection Control Consortium. During phase 2, the multidimensional approach for ventilator-associated pneumonia was implemented at each intensive care unit, in addition to the active surveillance. SETTING: Forty-four adult intensive care units in 38 hospitals, members of the International Nosocomial Infection Control Consortium, from 31 cities of the following 14 developing countries: Argentina, Brazil, China, Colombia, Costa Rica, Cuba, India, Lebanon, Macedonia, Mexico, Morocco, Panama, Peru, and Turkey. PATIENTS: A total of 55,507 adult patients admitted to 44 intensive care units in 38 hospitals. INTERVENTIONS: The International Nosocomial Infection Control Consortium ventilator-associated pneumonia multidimensional approach included the following measures: 1) bundle of infection-control interventions; 2) education; 3) outcome surveillance; 4) process surveillance; 5) feedback of ventilator-associated pneumonia rates; and 6) performance feedback of infection-control practices. MEASUREMENTS: The ventilator-associated pneumonia rates obtained in phase 1 were compared with the rates obtained in phase 2. We performed a time-series analysis to analyze the impact of our intervention. MAIN RESULT: During phase 1, we recorded 10,292 mechanical ventilator days, and during phase 2, with the implementation of the multidimensional approach, we recorded 127,374 mechanical ventilator days. The rate of ventilator-associated pneumonia was 22.0 per 1,000 mechanical ventilator days during phase 1, and 17.2 per 1,000 mechanical ventilator days during phase 2.The adjusted model of linear trend shows a 55.83% reduction in the rate of ventilator-associated pneumonia at the end of the study period; that is, the ventilator-associated pneumonia rate was 55.83% lower than it was at the beginning of the study. CONCLUSION: The implementation the International Nosocomial Infection Control Consortium multidimensional approach for ventilator-associated pneumonia was associated with a significant reduction in the ventilator-associated pneumonia rate in the adult intensive care units setting of developing countries.

International Nosocomial Infection Control Consortium report, data summary for 2002-2007, issued January 2008.

We report the results of an International Nosocomial Infection Control Consortium (INICC) surveillance study from 2002 through 2007 in 98 intensive care units (ICUs) in Latin America, Asia, Africa, and Europe. During the 6-year study, using Centers for Disease Control and Prevention (CDC) National Nosocomial Infections Surveillance System (NNIS) definitions for device-associated health care-associated infection, we collected prospective data from 43,114 patients hospitalized in the Consortium's hospital ICUs for an aggregate of 272,279 days. Although device utilization in the INICC ICUs was remarkably similar to that reported from US ICUs in the CDC's National Healthcare Safety Network, rates of device-associated nosocomial infection were markedly higher in the ICUs of the INICC hospitals: the pooled rate of central line-associated bloodstream infections (CLABs) in the INICC ICUs, 9.2 per 1000 CL-days, is nearly 3-fold higher than the 2.4-5.3 per 1000 CL-days reported from comparable US ICUs, and the overall rate of ventilator-associated pneumonia was also far higher, 19.5 vs 1.1-3.6 per 1000 ventilator-days, as was the rate of catheter-associated urinary tract infection, 6.5 versus 3.4-5.2 per 1000 catheter-days. Most strikingly, the frequencies of resistance of Staphylococcus aureus isolates to methicillin (MRSA) (80.8% vs 48.1%), Enterobacter species to ceftriaxone (50.8% vs 17.8%), and Pseudomonas aeruginosa to fluoroquinolones (52.4% vs 29.1%) were also far higher in the Consortium's ICUs, and the crude unadjusted excess mortalities of device-related infections ranged from 14.3% (CLABs) to 27.5% (ventilator-associated pneumonia).

Attributable cost and length of stay for patients with central venous catheter-associated bloodstream infection in Mexico City intensive care units: a prospective, matched analysis.

BACKGROUND: No information is available about the financial impact of central venous catheter (CVC)-associated bloodstream infection (BSI) in Mexico. OBJECTIVE: To calculate the costs associated with BSI in intensive care units (ICUs) in Mexico City. DESIGN: An 18-month (June 2002 through November 2003), prospective, nested case-control study of patients with and patients without BSI. SETTING: Adult ICUs in 3 hospitals in Mexico City. PATIENTS AND METHODS: A total of 55 patients with BSI (case patients) and 55 patients without BSI (control patients) were compared with respect to hospital, type of ICU, year of hospital admission, length of ICU stay, sex, age, and mean severity of illness score. Information about the length of ICU stay was obtained prospectively during daily rounds. The daily cost of ICU stay was provided by the finance department of each hospital. The cost of antibiotics prescribed for BSI was provided by the hospitals' pharmacy departments. RESULTS: For case patients, the mean extra length of stay was 6.1 days, the mean extra cost of antibiotics was US dollars 598, the mean extra hospital cost was US dollars 11,591, and the attributable extra mortality was 20%. CONCLUSIONS: In this study, the duration of ICU stay for patients with central venous catheter-associated BSI was significantly longer than that for control patients, resulting in increased healthcare costs and a higher attributable mortality. These conclusions support the need to implement preventive measures for hospitalized patients with central venous catheters in Mexico.

Device-associated nosocomial infections in 55 intensive care units of 8 developing countries.

BACKGROUND: Health care-associated infections from invasive medical devices in the intensive care unit (ICU) are a major threat to patient safety. Most published studies of ICU-acquired infections have come from industrialized western countries. In a Centers for Disease Control and Prevention (CDC) National Nosocomial Infections Surveillance (NNIS) System report, the U.S. pooled mean rates of central venous catheter (CVC)-related bloodstream infections, ventilator-associated pneumonia, and catheter-associated urinary tract infections were 4.0 per 1000 CVC days, 5.4 per 1000 mechanical ventilator days, and 3.9 per Foley catheter days, respectively. OBJECTIVE: To ascertain the incidence of device-associated infections in the ICUs of developing countries. DESIGN: Multicenter, prospective cohort surveillance of device-associated infection by using the CDC NNIS System definitions. SETTING: 55 ICUs of 46 hospitals in Argentina, Brazil, Colombia, India, Mexico, Morocco, Peru, and Turkey that are members of the International Nosocomial Infection Control Consortium (INICC). MEASUREMENTS: Rates of device-associated infection per 100 patients and per 1000 device days. RESULTS: During 2002-2005, 21,069 patients who were hospitalized in ICUs for an aggregate 137,740 days acquired 3095 device-associated infections for an overall rate of 14.7% or 22.5 infections per 1000 ICU days. Ventilator-associated pneumonia posed the greatest risk (41% of all device-associated infections or 24.1 cases [range, 10.0 to 52.7 cases] per 1000 ventilator days), followed by CVC-related bloodstream infections (30% of all device-associated infections or 12.5 cases [range, 7.8 to 18.5 cases] per 1000 catheter days) and catheter-associated urinary tract infections (29% of all device-associated infections or 8.9 cases [range, 1.7 to 12.8 cases] per 1000 catheter days). Notably, 84% of Staphylococcus aureus infections were caused by methicillin-resistant strains, 51% of Enterobacteriaceae isolates were resistant to ceftriaxone, and 59% of Pseudomonas aeruginosa isolates were resistant to fluoroquinolones. The crude mortality rate for patients with device-associated infections ranged from 35.2% (for CVC-associated bloodstream infection) to 44.9% (for ventilator-associated pneumonia). LIMITATIONS: These initial data are not adequate to represent any entire country, and likely variations in the efficiency of surveillance and institutional resources may have affected the rates that were detected. CONCLUSIONS: Device-associated infections in the ICUs of these developing countries pose greater threats to patient safety than in U.S. ICUs. Active infection control programs that perform surveillance of infection and implement guidelines for prevention can improve patient safety and must become a priority in every country.

Device-associated nosocomial infection rates in intensive care units in four Mexican public hospitals.

BACKGROUND: Routine surveillance of nosocomial infections has become an integral part of infection control and quality assurance in US hospitals. METHODS: As part of the International Nosocomial Infection Control Consortium, we performed a prospective nosocomial infection surveillance cohort study in 5 adult intensive care units of 4 Mexican public hospitals using the Centers for Disease Control and Prevention National Nosocomial Infections Surveillance system definitions. Site-specific nosocomial infection rates were calculated. RESULTS: The overall nosocomial infection rate was 24.4% (257/1055) and 39.0 (257/6590) per 1000 patient days. The most common infection was catheter-associated bloodstream infection, 57.98% (149/257), followed by ventilator-associated pneumonia, 20.23% (52/257), and catheter-associated urinary tract infection, 21.79% (56/257). The overall rate of catheter-associated bloodstream infections was 23.1 per 1000 device-days (149/6450); ventilator-associated pneumonia rate was 21.8 per 1000 device-days (52/2390); and catheter-associated urinary tract infection rate was 13.4 per 1000 device-days (56/4184). CONCLUSION: Our rates are similar to other hospitals of Latin America and higher than US hospitals.

The effect of process control on the incidence of central venous catheter-associated bloodstream infections and mortality in intensive care units in Mexico.

PURPOSE: To ascertain the effect of an infection control program including process control on intensive care unit (ICU) rates of intravascular device (IVD)-associated bloodstream infection (BSI). SETTING: Two level III adult ICUs in one public university hospital in Mexico: one medical surgical ICU and one neurosurgical ICU. POPULATION STUDY: All adult patients admitted to study units who had a central venous catheter (CVC) in place for at least 24 hrs. METHODS: A prospective before/after trial in which rates of IVD-associated BSI are determined during a period of active surveillance without process control (phase 1) were compared with rates of IVD-associated BSI after implementing an infection control program applying process control (phase 2). RESULTS: Six hundred five IVD-days were accumulated in phase 1, and 2824 IVD-days were accumulated during phase 2. Compliance with CVC site care and hand hygiene improved significantly from baseline during the study period: placing a gauze dressing over the catheter insertion site (99.24% vs. 86.69%, respectively; relative risk [RR] = 1.14; 95% confidence interval [CI] = 1.07-1.22; p = .0000), proper use of gauze for vascular catheter insertion site (97.87% vs. 84.21%, respectively; RR = 1.16; 95% CI = 1.09-1.24; p = .0000), documentation of the duration of the administration set of the vascular catheter (93.85% vs. 40.69%, respectively; RR = 2.34; 95% CI = 2.14-2.56; p = .0000), and hand hygiene before contact with the patient (84.9% vs. 62%, respectively; RR = 1.37; 95% CI = 1.21-1.51; p = .0000). Overall rates of IVD-associated BSI were lowered significantly from baseline rates after implementation of process control (19.5 vs. 46.3 BSIs per 1000 IVD-days, respectively; RR = 0.42; 95% CI = 0.27-0.66; p = .0001). Overall rates of crude unadjusted mortality were lowered significantly from baseline rates (48.5% vs. 32.8% per 100 discharges, respectively; RR = 0.68; 95% CI = 0.50-0.31; p = .01). CONCLUSION: Implementation of an infection control program utilizing education, process control, and performance feedback was associated with significant reductions in rates of IVD-associated BSI and mortality.

Nuevas alternativas en el tratamiento de la vaginosis bacteriana / New treatment alternatives in bacterial vaginosis

Se comparó la eficacia y seguridad de clindamicina crema vaginal al 2 por ciento con metronidazol oral en el tratamiento de 184 mujeres con vaginosis bacteriana sintomática en un estudio multicéntrico, aleatorio, doble-ciego, controlado. La duración del tratamiento fue de siete días, utilizando placebo en cápsulas en el grupo clindamicina y placebo crema en el grupo metronidazol. Las pacientes fueron observadas durante las visitas de seguimiento (4-13 y 20-43 días después de completar su terapia). El resultado global del tratamiento, indicó que clindamicina en crama vaginal ofrece una eficacia similar a la demostrada con metronidazol oral. Los porcentajes de curación/mejoría fueron 87 por ciento para el grupo de clindamicina y 79 por ciento para el grupo de metronidazol, sin diferencias significativas (p> 0.22). No se observaron recaídas en el grupo de clindamicina mientras que el grupo de metronidazol, se presentaron en 7 por ciento de los casos. El porcentaje de fracaso fue menor en el grupo de clindamicina (3 por ciento) que en el grupo que recibió metronidazol oral (15 por ciento). Ambos fármacos fueron bien tolerados. Los efectos secundarios más frecuentemente observados fueron irritación vulvovaginal y el desarrollo de vaginitis/cervicitis. El único efecto secundario clasificado como serio fue erupción cutánea generalizada en una paciente que recibió metronidazol. Se concluye que la clindamicina en crema vaginal al 2 por ciento es una alternativa eficaz y segura al metronidazol oral, para el tratamiento de la vaginosis bacteriana; siendo el tratamiento de elección para las mujeres durante el primer trimestre de la gestación