RESUMEN
To understand the value of computer-aided disproportionality analysis (DA) in relation to current pharmacovigilance signal detection methods, four products were retrospectively evaluated by applying an empirical Bayes method to Merck's post-marketing safety database. Findings were compared with the prior detection of labeled post-marketing adverse events. Disproportionality ratios (empirical Bayes geometric mean lower 95% bounds for the posterior distribution (EBGM05)) were generated for product-event pairs. Overall (1993-2004 data, EBGM05> or =2, individual terms) results of signal detection using DA compared to standard methods were sensitivity, 31.1%; specificity, 95.3%; and positive predictive value, 19.9%. Using groupings of synonymous labeled terms, sensitivity improved (40.9%). More of the adverse events detected by both methods were detected earlier using DA and grouped (versus individual) terms. With 1939-2004 data, diagnostic properties were similar to those from 1993 to 2004. DA methods using Merck's safety database demonstrate sufficient sensitivity and specificity to be considered for use as an adjunct to conventional signal detection methods.
Asunto(s)
Diseño Asistido por Computadora/normas , Vigilancia de Productos Comercializados/métodos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Bases de Datos Factuales/estadística & datos numéricos , Industria Farmacéutica/métodos , Industria Farmacéutica/estadística & datos numéricos , Industria Farmacéutica/tendencias , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/inducido químicamente , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Vigilancia de Productos Comercializados/estadística & datos numéricos , Reproducibilidad de los Resultados , Estudios Retrospectivos , Factores de Tiempo , Vacunas/efectos adversosRESUMEN
BACKGROUND AND OBJECTIVES: To deliver effective medical care to patients from all cultural backgrounds, family physicians need to be culturally sensitive and culturally competent. Our department implemented and evaluated a 3-year curriculum to increase residents' knowledge, skills, and attitudes in multicultural medicine. Our three curricular goals were to increase self-awareness about cultural influences on physicians, increase awareness about cultural influences on patients, and improve multicultural communication in clinical settings. Curricular objectives were arranged into five levels of cultural competence. Content was presented in didactic sessions, clinical settings, and community medicine projects. METHODS AND RESULTS: Residents did self-assessments at the beginning of the second year and at the end of the third year of the curriculum about their achievement and their level of cultural competence. Faculty's evaluations of residents' levels of cultural competence correlated significantly with the residents' final self-evaluations. Residents and faculty rated the overall curriculum as 4.26 on a 5-point scale (with 5 as the highest rating). CONCLUSIONS: Family practice residents' cultural knowledge, cross-cultural communication skills, and level of cultural competence increased significantly after participating in a multicultural curriculum.
Asunto(s)
Curriculum , Educación Médica/métodos , Educación/métodos , Medicina Familiar y Comunitaria/educación , Conocimientos, Actitudes y Práctica en Salud , Internado y Residencia/organización & administración , Docentes Médicos/organización & administración , Docentes Médicos/normas , Humanos , Internado y Residencia/normas , Evaluación de Programas y Proyectos de Salud , Estudios Retrospectivos , Estados UnidosRESUMEN
Catholic health care facilities' responsibility to ensure that treatment decisions are based on the patient's best interests and sound medical practice rather than on the person's disability poses difficult legal and moral questions in cases involving terminally ill patients and handicapped newborns. For example, hospitals and physicians, to avoid undertreatment, may be induced to use all available life-sustaining technology. Such extraordinary measures, however, may not be in the patient's best interests if they place undue burden on the patient and family. Ordinary care, which usually means nourishment and hydration, also may be deemed morally optional. Some health care professionals, in light of new information about hydration's effects on terminal patients, suggest that no moral obligation to give ordinary care exists in certain "hopeless" cases. The prohibition in many facilities of written "do not resuscitate" orders also is a source of controversy. Appropriate guidelines, however, can help to reduce decision makers' uncertainty and ease the work of hospital personnel. The overriding concern, though, is who should make the decision to withhold or terminate treatment. In most cases the courts have assumed this responsibility themselves or have delegated it to others. Little consensus, however, has formed concerning whether family members, physicians, or hospital ethics committees are better able to make such decisions. Since few court rulings are available to guide those who must make treatment decisions, Catholic health professionals must stay abreast of the developing law and resist efforts to promote philosophies that measure life according to "quality" or productivity potential.