RESUMO
Real-world data (RWD) and real-world evidence (RWE) are becoming essential tools for informing regulatory decision making in health care and offer an opportunity for all stakeholders in the healthcare ecosystem to evaluate medical products throughout their lifecycle. Although considerable interest has been given to regulatory decisions supported by RWE for treatment authorization, especially in rare diseases, less attention has been given to RWD/RWE related to in vitro diagnostic (IVD) products and clinical decision support systems (CDSS). This review examines current regulatory practices in relation to IVD product development and discusses the use of CDSS in assisting clinicians to retrieve, filter, and analyze patient data in support of complex decisions regarding diagnosis and treatment. The review then explores how utilizing RWD could augment regulatory body understanding of test performance, clinical outcomes, and benefit-risk profiles, and how RWD could be leveraged to augment CDSS and improve safety, quality, and efficiency of healthcare practices. Whereas we present examples of RWD assisting in the regulation of IVDs and CDSS, we also highlight key challenges within the current healthcare system which are impeding the potential of RWE to be fully realized. These challenges include issues such as data availability, reliability, accessibility, harmonization, and interoperability, often for reasons specific to diagnostics. Finally, we review ways that these challenges are actively being addressed and discuss how private-public collaborations and the implementation of standardized language and protocols are working toward producing more robust RWD and RWE to support regulatory decision making.
Assuntos
Sistemas de Apoio a Decisões Clínicas , Humanos , Ecossistema , Reprodutibilidade dos Testes , Doenças Raras , Tomada de DecisõesRESUMO
Resumen Objetivo: Evaluar el nivel de orientación empática de los alumnos del Programa de Odontología de la Fundación Universitaria San Martín, sede Puerto Colombia (Atlántico, Colombia). Materiales y métodos: Se llevó a cabo un estudio descriptivo, de corte transversal y ex post facto causa-efecto. La muestra estuvo conformada por 102 estudiantes de 1°, 2°, 3°, 4° y 5° año de odontología, a quienes se les aplicó la Escala de Empatía Médica de Jefferson (EEM). Los datos primarios obtenidos fueron sometidos a la prueba de normalidad de Shapiro-Wilk en los dos factores, Año y Sexo, y a la prueba de homocedasticidad de Levene. Se compararon las medias mediante un Análisis de Varianza Bifactorial Modelo III con interacción de primer orden. Se estimó la potencia observada y el tamaño del efecto. Resultados: No se encontraron diferencias significativas (p>0,05) en el factor "curso" y en la interacción "curso y género", pero sí se observaron diferencias altamente significativas (p<0,005) en el factor "género". La orientación empática es mayor en el género femenino que en el masculino, pero ambos elementos son independientes entre sí en la población estudiada. Conclusiones: Los resultados obtenidos muestran que la variable estudiada no cambia demasiado entre los distintos cursos de la carrera, pero sí se marcan en cuarto año. No se observaron diferencias significativas entre los géneros.
Abstract Objetive: To assess the level of empathetic orientation of the dentistry students at the Fundación Universitaria San Martín, sede Puerto Colombia (Atlántico, Colombia). Materialsand methods: There were carried out a descriptive, cross- sectional research. 102 students of the Dentistry School who belonged to 1°, 2°, 3° 4°, and 5° levels participated in the study. The Jefferson Scale of Physician Empathy was applied. The Shapiro- Wilk normality test and homocedasticityLevene test were performed for the data analysis. Descriptive statistician statigraphs were considered in all the studied factors. Finally, average comparison mean was made through a Bifactorial analysis of variance. Results: No significant differences (p> 0.05) in the course and factor in ongoing interaction and gender, but highly significant differences were observed (p <0.005) in the "gender" factor. Empathic orientation is higher in females than males, but both are independent of each other in the study population. Conclusions: The results show that the studied variable does not change much between the different race courses, but if you mark in fourth year. No significant differences between genders.
RESUMO
Objetivo: Evaluar el nivel de percepción empática de alumnos de la Facultad de Estomatología Roberto Beltrán de la Universidad Peruana Cayetano Heredia (Perú). Material y métodos: Se realizó un estudio de investigación no experimental, descriptiva, de corte transversal y ex post facto causa- efecto. En la investigación participaron 258 alumnos de una población de 450 que cursan los niveles 1º, 2º, 3º, 4º y 5º de la Facultad de Estomatología de la Universidad Peruana Cayetano Heredia (Perú), a quienes se les aplicó la Escala de Empatía Médica de Jefferson (EEMJ). Para el análisis de los datos obtenidos se realizó la prueba de normalidad de Shapiro-Wilk y la prueba de homocedasticidad de Levene Posteriormente se estimaron los estadígrafos descriptivos en todos los factores estudiados, la comparación de las medias se realizó mediante un Análisis de varianza bifactorial y una prueba de comparación múltiple de Duncan y finalmente, se construyó un Baremo que sirvió para el análisis descriptivo porcentual para cada uno de los tres factores de empatía (ôtoma de perspectivaõ, ôatención por compasiónõ y habilidad para ponerse en el lugar del paciente) Resultados: Los puntajes obtenidos en la (EEMJ) Resultados: Los puntajes obtenidos en la (EEMJ) Las mujeres presentaron mayores niveles que los hombres de la variable orientación empática. El mayor porcentaje de alumnos se ubican en la categoría Medio de empatía en los tres factores (ôtoma de perspectivaõ, ôatención por compasiónõ y habilidad para ponerse en el lugar del paciente). Conclusiones: Los estudiantes de estomatología de los niveles 1°, 2°,3º, 4º y 5º de la Universidad Peruana Cayetano Heredia (Perú) presentan un nivel medio de orientación empática. Las mujeres presentan mayor nivel de orientación empática que los hombres.
Objective: To assess empathic perception level of students from Roberto Beltran Dentistry Faculty of Universidad Peruana Cayetano Heredia (Peru). Material and Methods: A non-experimental, descriptive, cross-sectional and ex post facto causal research study was performed. The research involved 258 students from population of 450 that present levels 1st, 2nd, 3rd, 4th, and 5th, from Roberto Beltran Dentistry Faculty of Universidad Peruana Cayetano Heredia (Peru), who were administered the Jefferson Physician Empathy Scale (JPES). For data analysis Shapiro-Wilk normality test and Levene homoscedasticity tests were performed. Later descriptive statistics were estimated in all factors studied, means comparison was performed using analysis Bivariate variance test and Duncan multiple comparison test and finally a Baremo was built that was used for percentage descriptive analysis for each three empathy factors (ôperspective takingõ, ôcompassionate careõ and skill by putting yourself in patient). Results: Scores obtained in the (JPES) are significantly higher in fifth year than remaining years. Women had higher levels than men in empathic orientation variable. . The greatest percentage of students are placed in the medium category empathy in the three factors (ôperspective takingõ, ôcom passionate careõ and skill by putting yourself in patient). Conclusions: Stomatology students al levels 1st, 2nd, 3rd, 4th and 5th from Universidad Peruana Cayetano Heredia (Peru) have medium empathic orientation level average. Women have a higher level of guidance empathic than men.