[Identification of adverse events in hospitalised influenza patients]. / Identificación de eventos adversos en pacientes hospitalizados por gripe.

OBJECTIVE: To test the inter-observer agreement in identifying adverse events (AE) in patients hospitalized by flu and undergoing precautionary isolation measures. METHODS: Historical cohort study, 50 patients undergoing isolation measures due to flu, and 50 patients without any isolation measures. RESULTS: The AE incidence ranges from 10 to 26% depending on the observer (26% [95%CI: 17.4%-34.60%], 10% [95%CI: 4.12%-15.88%], and 23% [95%CI: 14.75%-31.25%]). It was always lower in the cohort undergoing the isolation measures. This difference is statistically significant when the accurate definition of a case is applied. The agreement as regards the screening was good (higher than 76%; Kappa index between 0.29 and 0.81). The agreement as regards the accurate identification of AE related to care was lower (from 50 to 93.3%, Kappa index from 0.20 to 0.70). CONCLUSIONS: Before performing an epidemiological study on AE, interobserver concordance must be analyzed to improve the accuracy of the results and the validity of the study. Studies have different levels of reliability. Kappa index shows high levels for the screening guide, but not for the identification of AE. Without a good methodology the results achieved, and thus the decisions made from them, cannot be guaranteed. Researchers have to be sure of the method used, which should be as close as possible to the optimal achievable.

Estudio de percepción de seguridad en pacientes aislados y no aislados en un hospital de agudos y análisis de concordancia con su identificación por los profesionales / Study of perception of security in isolated and non-isolated patients in an acute hospital and concordance analysis with their identification by the professionals

Objetivo: Evaluar la percepción del paciente sobre la ocurrencia de incidentes relacionados con la seguridad (IRS) y eventosadversos (EA) en pacientes sometidos a precauciones de transmisión (pacientes aislados) y pacientes no aislados durante suingreso hospitalario y compararlo con los identificados por los profesionales sanitarios en la revisión de las historias clínicas en unhospital público universitario de agudos de la provincia de Alicante.Metodología: Estudio transversal mediante encuesta telefónica a pacientes aislados y no aislados con cuestionario validado depercepción de seguridad sobre la ocurrencia de IRS y EA y posterior análisis de concordancia mediante coeficiente Kappa con losidentificados por el personal sanitario en la revisión de historias clínicas.Resultados: Los pacientes aislados respecto a los no aislados, manifestaron haber tenido menos complicaciones médicas poralguna medicación y estas eran poco graves. Por el contrario, manifestaron tener algo más de complicaciones médicas porintervenciones quirúrgicas y ser poco graves. Finalmente, opinaron haber padecido más eventos adversos, respecto a los noaislados. Las diferencias no fueron estadísticamente significativas. En los resultados del índice de concordancia (índice Kappa),de identificación de EA de los pacientes durante su ingreso, y los identificados por los profesionales sanitarios en la revisión de lashistorias clínicas, se observó una fuerza de concordancia leve (Kappa= 0,061).Discusión: Los resultados de nuestro estudio pueden estar influenciados por una escasa información a los pacientes sobre suproceso clínico (diagnóstico, tratamientos y efectos adversos, etc...), esto podría ser la causa del bajo nivel de detección porlos pacientes de los incidentes relacionados con la seguridad que hayan podido suceder durante su ingreso hospitalario...(AU)

Objective: To evaluate the perception of the patient about the occurrences of IRS and AE in patients subjected to transmissionprecautions (isolated patients) and non-isolated patients during their hospital admission and compare it with those identified bythe health professionals in the review of the medical records in a public university hospital for acute care in the province of Alicante.Methodology: Cross-sectional study using a telephone survey in isolated and non-isolated patients with a validated questionnaire in the perception of safety on the occurrence of IRS and AEs and subsequent concordance analysis using the Kappa coefficient withthe identifiers by the health personnel in the review of medical records.Results: The isolated patients compared to the non-isolated ones, stated that they had fewer medical complications due to anymedication and these were not serious. On the contrary, they stated that they had slightly more medical complications fromsurgical interventions and that they were not very serious. Finally, they thought they had suffered more adverse events, comparedto those not isolated. The differences were not statistically significant. In the results of the concordance index (Kappa index), forthe identification of AEs of the patients during their admission, and those identified by the health professionals in the review of themedical records, a slight strength of concordance was discovered (Kappa= 0.061).Discussion: The results of our study may be influenced by insufficient information given to patients about their clinical process(diagnosis, treatments and adverse effects, etc...), this could be the cause of the low level of detection by patients of incidentsrelated to the security that may have happened during their hospital admission...(AU)

Identificación de eventos adversos en pacientes hospitalizados por gripe / Identification of adverse events in hospitalised influenza patients

Objetivos: Testar la fiabilidad interobservador de la guía de cribado y del formulario modular de revisión (MRF2) para identificar eventos adversos (EA). Comparar la incidencia de EA entre un grupo de pacientes sometidos a precauciones de aislamiento de contacto y gotas por gripe frente a un grupo de pacientes no aislados. Método: Estudio de casos y controles anidados en una cohorte. Los casos son 50 pacientes sometidos a precauciones de aislamiento por gripe, y los controles son 50 pacientes ingresados y no aislados. Resultados: La incidencia de EA varía entre el 10 y el 26% por efecto del observador (26% [IC 95%: 17,4-34,60%]; 10% [IC 95%: 4,12-15,88%]; 23% [IC 95%: 14,75-31,25%]). Es siempre menor en la cohorte expuesta al aislamiento que en la no expuesta, y esa diferencia alcanza significación estadística cuando aplicamos el criterio de máxima exigencia en la definición de caso. La concordancia respecto del cribado fue buena (porcentaje simple de concordancia superior al 76%; índice Kappa entre 0,29 y 0,81). La concordancia respecto de la identificación precisa de EA relacionado con la asistencia fue menor (porcentaje de concordancia entre el 50 y el 93,3%; índice Kappa de 0,20 a 0,70). Conclusiones: Antes de realizar un estudio epidemiológico sobre EA hay que analizar la fiabilidad interobservador para mejorar la precisión de los resultados y, por ende, la validez del estudio. Los revisores presentan diferentes grados de concordancia. El índice Kappa muestra niveles elevados para la guía de cribado, no así para la identificación de EA. Sin una buena metodología no se pueden garantizar los resultados alcanzados y, consecuentemente, las decisiones tomadas a partir de ellos. Por tanto, los investigadores han de ser garantes del método utilizado y este debe acercarse lo más posible al óptimo alcanzable (AU)

Objective: To test the inter-observer agreement in identifying adverse events (AE) in patients hospitalized by flu and undergoing precautionary isolation measures. Methods: Historical cohort study, 50 patients undergoing isolation measures due to flu, and 50 patients without any isolation measures. Results: The AE incidence ranges from 10 to 26% depending on the observer (26% [95% CI: 17.4%-34.60%], 10% [95% CI: 4.12%-15.88%], and 23% [95% CI: 14.75%-31.25%]). It was always lower in the cohort undergoing the isolation measures. This difference is statistically significant when the accurate definition of a case is applied. The agreement as regards the screening was good (higher than 76%; Kappa index between 0.29 and 0.81). The agreement as regards the accurate identification of AE related to care was lower (from 50 to 93.3%, Kappa index from 0.20 to 0.70). Conclusions: Before performing an epidemiological study on AE, interobserver concordance must be analyzed to improve the accuracy of the results and the validity of the study. Studies have different levels of reliability. Kappa index shows high levels for the screening guide, but not for the identification of AE. Without a good methodology the results achieved, and thus the decisions made from them, cannot be guaranteed. Researchers have to be sure of the method used, which should be as close as possible to the optimal achievable (AU)