Effectiveness of Additional Risk Minimization Measures for Atezolizumab in the European Union.

BACKGROUND: A Guide for Healthcare Professionals (HCP Guide) and patient alert card (PAC) for atezolizumab as additional risk minimization measures for physicians were distributed to raise awareness and help in the detection and management of immune-related adverse drug reactions. OBJECTIVES: The main objective of this study was to assess the receipt, knowledge, and behaviors of physicians regarding the atezolizumab HCP Guide and PAC. METHODS: A multi-country, one-wave, observational, cross-sectional, web-based, self-reported physician survey was conducted to assess the level of knowledge of key messages related to immune-related adverse drug reactions summarized in the atezolizumab HCP Guide and PAC among physicians (oncologists, pulmonologists, and urologists) prescribing atezolizumab in six European countries (Denmark, Germany, Italy, Spain, Sweden, and the UK). Responses regarding the receipt, understanding and use of the materials, and knowledge and behavior related to the HCP Guide and PAC are presented as percentages and continuous scores scaled out of 100 points, with corresponding 95% confidence intervals (CIs). RESULTS: Among 313 physicians (255 oncologists, 30 pulmonologists, and 28 urologists), 77.4% received the HCP Guide and 74.2% the PAC. The HCP Guide was read by 71.3% of the 267 physicians who received the materials, and the mean usage score was 69.5 (95% CI 66.0-72.9), and 57.1% of physicians had scores ≥ 70. The HCP Guide was completely understood by 85.4% of physicians who had read it. Mean knowledge scores were 63.9 (95% CI 62.1-65.7) and 39.4% of physicians had correct knowledge scores ≥ 70. Mean knowledge scores were 66.8 (95% CI 64.9-68.7) for receipt of both the HCP Guide and PAC, 59.4 (95% CI 55.5-63.4) for one of the materials, and 60.8 (95% CI 55.4-66.2) for having received none of the materials. Mean behavior scores were 78.9 (95% CI 76.8-81.0), and 74.8% of physicians had behavior scores ≥ 70. The mean behavior score was 79.0 (95% CI 76.5-81.5) for those who received both the HCP Guide and PAC, 76.9 (95% CI 72.2-81.5) for receipt of one of the materials, and 81.5 (95% CI 75.0-88.0) for those who received none of the materials. CONCLUSIONS: The study assessed the effectiveness of the atezolizumab additional risk minimization educational materials among physicians in six European countries, using process indicators. The educational materials reached over 70% of target physicians, 57.1% of whom reported using them. Knowledge and behavior related to immune-related adverse drug reactions for atezolizumab were no better in those who received the additional risk minimization educational materials. The results support the safe use of atezolizumab by these physician groups and contributed to the European Medicines Agency permitting removal of the HCP Guide.

Uso del preservativo masculino en las relaciones con coito vaginal de jóvenes españoles entre catorce y veinticuatro años / Male condom usage in vaginal intercourse relations by spanish youngsters aged fourteenth to twenty fourth

En la actualidad, el preservativo masculino continúa siendo el principal método para prevenir enfermedades de transmisión sexual, incluido el VIH/SIDA. El objetivo de este estudio transversal analítico-descriptivo es evaluar la frecuencia de uso de dicho preservativo en las relaciones sexuales coito-vaginales de jóvenes españoles con edades entre 14 y 24 años, e identificar las variables relacionadas con los factores que predisponen, facilitan y refuerzan su utilización. La muestra estuvo integrada por 2.171 jóvenes de las comunidades de Galicia, Madrid y Andalucía. El 50,4% de los jóvenes encuestados manifestaron haber tenido relaciones coitovaginales en los últimos seis meses. Se encontró que ser mayor de 18 años y tener más actividad sexual se asocia a menor frecuencia de uso del preservativo. Se tomó como referencia el modelo Precede; los análisis de regresión logística identificaron como predictores confiables: la intención de conducta de no riesgo y la habilidad autopercibida para usar el preservativo masculino con la pareja habitual (dentro del grupo de factores predisponentes); uso del preservativo masculino la primera vez que mantuvo relaciones coito-vaginales, hablar con la pareja sobre las prácticas sexuales por llevar a cabo, hablar con la pareja sobre los métodos de prevención que se van a utilizar y la baja frecuencia de relaciones con penetración vaginal (dentro del grupo de factores facilitadores); y haber sentido agobio, culpa o arrepentimiento por no tomar precauciones tras alguna práctica coito-vaginal (dentro del grupo de factores reforzantes). Los resultados de este estudio confirman la utilidad del modelo Precede para efectuar el diagnóstico de la conducta sexual.

The male condom continues to be the primary method of preventing sexually transmitted diseases, including HIV. This is a transversal descriptive research, their objective is assess the frequency of use of the male condom in sexual relations involving vaginal penetration using a sample of young Spanish men from 14 to 24 years of age. We attempt to identify reliable predictors for condom use, factors that predispose, facilitate and reinforce its consistent use. The sample was made up of 2.171 young belonging to three regions in Spain (Galicia, Madrid and Andalusia) among the ages of 14 and 24. A 50,4 % of the young men polled expressed having had vaginal intercourse in the previous six months. Participants who were 18-year-old and older as well as those who engaged more frequently in sexual activity were less likely to use the male condom at all times. Taking the Precede model as a point of reference, the models of logistic regression identified the following variables as reliable predictors: a declared intention of partaking in non-risk conduct with a stable partner and the self-perceived skill at using the male condom with a stable partner (within the group of predisposing factors); having used the male condom the first time they engaged in vaginal intercourse, the habit of speaking to one's partner about sexual practices, speaking to one's partner about prevention methods to use, and low frequency of sexual relations with vaginal penetration (within the group of facilitating factors); having felt a sense of guilt or repentance for not taking precautions after engaging in vaginal intercourse (within the group of reinforcing factors). In conclusion the results of this study confirm the utility of the Precede model to carry out the diagnosis of the sexual behaviour.