ABSTRACT
Abstract It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.
Subject(s)
Humans , Research Design , Ethics Committees, Research/organization & administration , Observational Studies as Topic/ethics , Research Personnel/organization & administration , Registries/ethics , Interviews as Topic/methods , Retrospective Studies , Informed Consent/ethicsABSTRACT
Niña de 10 años con diarrea, abdominalgia, pérdida de peso y febrícula de un mes y medio de evolución. Los hallazgos analíticos y ecográficos hicieron sospechar una enfermedad inflamatoria intestinal. La endoscopía y la histología mostraron hallazgos compatibles con la enfermedad de Crohn. Se inició un tratamiento con mesalazina y nutrición enteral exclusiva, y se anadieron corticoides, inmunosupresores y ácido ursodesoxicólico por la persistencia de colestasis e hipergammaglobulinemia. La colangiorresonancia y la biopsia hepática confirmaron el diagnóstico de colangitis esclerosante primaria concomitante. La asociación entre la enfermedad de Crohn y la colangitis esclerosante primaria es muy poco frecuente; predomina en varones de entre los 20 y los 40 años de edad; y presenta una gran variabilidad clínica. El diagnóstico de confirmación requiere la realización de una colangiorresonancia o colangiopancreatografía retrógrada endoscópica. El pronóstico es malo y no existe ningún tratamiento capaz de frenar la progresión de la enfermedad.
A 10 year old girl with diarrhea, abdominal pain, weight loss and fever of one month and a half of evolution. Analytical and sonographic findings raised the possibility of inflammatory bowel disease. Endoscopy and histology showed findings consistent with Crohn's disease. Treatment was initiated with mesalazine and exclusive enteral nutrition. Later corticosteroid treatment, immunosuppressive drugs and ursodeoxycholic acid were added due to cholestasis and persistent hypergammaglobulinemia. Magnetic resonance cholangiography and liver biopsy confirmed the diagnosis of concomitant primary sclerosing cholangitis. The association between Crohn's disease and primary sclerosing cholangitis is rare, predominantly in males between 20 and 40 years old and it presents a great clinical variability. The confirmation of the diagnosis requires magnetic resonance cholangiography or endoscopic retrograde cholangiopancreatography. The prognosis is poor and there is no treatment to slow the progression of the disease.
Subject(s)
Humans , Female , Child , Cholangitis, Sclerosing/etiology , Crohn Disease/complicationsABSTRACT
Resumen
Introducción: es reconocido que el trabajo de enfermería en el contexto hospitalario, el estrés tiene diversas fuentes y repercusiones en la salud física y mental de las enfermeras. Los efectos del estrés laboral se han descrito como síndrome de burnout (sb), por lo que en este trabajo se analizan los elementos involucrados en el problema.
Desarrollo: se presenta la evidencia científica sobre los factores que originan el sb: situacionales (características del trabajo, ocupacionales y organizacionales); individuales: (características sociodemográficas, de personalidad y actitudes hacia el trabajo) y la violencia hacia las enfermeras como un factor emergente. Se presenta la evidencia sobre las consecuencias en las enfermeras y en las instituciones, así como las intervenciones que han mostrado efectividad a nivel individual (intervenciones educativas y psicosociales) y a nivel organizacional.
Conclusiones: para la práctica es crucial que las enfermeras administradoras y el personal conozcan todo lo relativo al sb para prevenirlo e intervenir oportunamente. En investigación es prioritario construir una línea que supere las diferencias metodológicas que limitan comparaciones de prevalencia, factores relacionados y consecuencias en el contexto nacional. Es prioritario incluir la evaluación de intervenciones.
Abstract
Introduction: ¡t is recognized that nursing work in the hospital setting has several sources of stress with implications for nurses' physical and mental health. The effects of work stress have been described as Burnout syndrome (BS), so this paper examines the elements involved in the problem.
Development: it presents the scientific evidence on the factors causing the BS: situational (job characteristics, occupational and organizational), individual (sociodemographic characteristics, personality and attitudes to work) and violence towards nurses as an emerging factor. It presents evidence on the impact on nurses and the institutions and interventions that have shown effectiveness at the individual level (education and psychosocial interventions) and at organizational level.
Conclusions: for daily practice it is very important that manager nurses and staff know all about BS to prevent and intervene promptly. Research priority is to build a line that overcomes the methodological differences that limit comparisons of prevalence, associated factors and consequences in the national context. To include evaluation of interventions is a preponderant issue.