Efectividad de una intervención para mejorar la cultura de seguridad. ¿Menos es más? / Effectiveness of an intervention to improve safety culture. Less is more?

Objetivo. Evaluar el impacto de una iniciativa a largo plazo para contribuir a la mejora en cultura de seguridad entre profesionales de un área de salud, y conocer su utilidad percibida. Material y métodos. Estudio de intervención no controlado en una organización de la red pública asistencial incluyendo hospital de tercer nivel y 5.000 profesionales. Para medir impacto se realizó la encuesta de la Agency for Healthcare Research and Quality (AHRQ) por vía telefónica. Se midieron 7 dimensiones de cultura antes del proyecto (2012, n=100) y a los 3 años (2015, n=207). Se compararon variaciones entre 2012 y los conocedores del proyecto en 2015, y entre estos y no conocedores. Se valoró la utilidad (escala Likert de 5 ítems, alta utilidad medianas de 4 o superior). Resultados. Tasas de respuesta homogéneas superiores al 80%. El 41,5% conocían el proyecto (IC95%: 34,8-48,3), percibido de alta utilidad. En ambas comparaciones, variación negativa en «percepción de seguridad» (−9,9%, p<0,01, frente a 2012 y −4,2% entre grupos 2015) y «retroalimentación y comunicación sobre errores» (−10,0% frente a 2012 y −8,9% entre grupos 2015, p<0,05); y positiva no significativa en «franqueza en comunicación» (1,3% frente a 2012 y 6,9% entre grupos 2015). El «apoyo de gerencia» mejora no significativamente en 2015 (37,0%, IC95%: 30,9-43,1 en conocedores, y 38,3%, IC95%: 33,1-43,4 en no conocedores) frente a 2012 (31,4%, IC95%: 28,4-39,7. Conclusiones. Se detecta empeoramiento paradójico en varias dimensiones, probablemente por inmadurez de la organización y el instrumento utilizado. Herramientas que contemplen el grado de madurez pudieran ser más adecuadas en medición de cambios culturales, siendo necesarios más estudios (AU)

Objective. To assess the impact of a long-term initiative to improve safety culture among professionals working in a Health Area, and to know their perceived usefulness. Material and methods. An uncontrolled intervention study was designed in a public health care organization including a 3rd level hospital and 5,000 professionals. To measure the impact, the AHRQ Survey was conducted by telephone. A total of 7 dimensions of culture were measured, before starting the project (2012, n=100) and 3 years later (2015, n=207). Variations between 2012 and the respondents aware of the project in 2015 (RAP) were compared, as also between this last group and the rest of respondents (RNAP). The utility was assessed using a 5-item Likert scale, defining higher utility by medians 4 or higher. Results. The response rates were above 80%. In 2015, the 41.5% of respondents were RAP (95%CI: 34.8-48.3), which was perceived as of high utility. Negative variations were detected in "sense of security" (−9.9%, P<.01, vs. 2012, and −4.2% between 2015 groups) and "feedback and communication errors" (−10.0% vs. 2012, and −8.9% between 2015 groups, P<.05). There was a not-significant positive variation in "openness in communication" (1.3% vs. 2012, and 6.9% between 2015 groups). The "management support" showed a not-significant improve in 2015 (37.0%, 95%CI: 30.9-43.1, in RAP; and 38.3%, 95%CI: 33.1-43.4, in RANP) in comparison to 2012 (31.4%, 95%CI: 28.4-39.7). Conclusions. A paradoxical worsening is detected in several dimensions, this probably due to immaturity of the organization and the instrument used. Thus, tools explicitly considering the degree of maturity may be more appropriate to measure cultural changes, although more studies are needed (AU)

[Effectiveness of an intervention to improve safety culture. Less is more?] / Efectividad de una intervención para mejorar la cultura de seguridad. ¿Menos es más?

OBJECTIVE: To assess the impact of a long-term initiative to improve safety culture among professionals working in a Health Area, and to know their perceived usefulness. MATERIAL AND METHODS: An uncontrolled intervention study was designed in a public health care organization including a 3rd level hospital and 5,000 professionals. To measure the impact, the AHRQ Survey was conducted by telephone. A total of 7 dimensions of culture were measured, before starting the project (2012, n=100) and 3 years later (2015, n=207). Variations between 2012 and the respondents aware of the project in 2015 (RAP) were compared, as also between this last group and the rest of respondents (RNAP). The utility was assessed using a 5-item Likert scale, defining higher utility by medians 4 or higher. RESULTS: The response rates were above 80%. In 2015, the 41.5% of respondents were RAP (95%CI: 34.8-48.3), which was perceived as of high utility. Negative variations were detected in "sense of security" (-9.9%, P<.01, vs. 2012, and -4.2% between 2015 groups) and "feedback and communication errors" (-10.0% vs. 2012, and -8.9% between 2015 groups, P<.05). There was a not-significant positive variation in "openness in communication" (1.3% vs. 2012, and 6.9% between 2015 groups). The "management support" showed a not-significant improve in 2015 (37.0%, 95%CI: 30.9-43.1, in RAP; and 38.3%, 95%CI: 33.1-43.4, in RANP) in comparison to 2012 (31.4%, 95%CI: 28.4-39.7). CONCLUSIONS: A paradoxical worsening is detected in several dimensions, this probably due to immaturity of the organization and the instrument used. Thus, tools explicitly considering the degree of maturity may be more appropriate to measure cultural changes, although more studies are needed.

Acquired haemophilia A in a patient with chronic hepatitis C virus infection receiving treatment with pegylated interferon plus ribavirin: role of rituximab

Background: Acquired haemophilia is an uncommon condition caused by the development of clotting factor inhibitors. To eliminate them, immunosuppressive therapy with corticosteroids and cytotoxic drugs is required. Methods: We describe a case of rituximab use in acquired haemophilia refractory to conventional therapy in a 63 year old male patient with chronic hepatitis C virus infection who was receiving treatment with pegylated-interferon-α-2a plus ribavirin. Results: After 21 weeks of antiviral therapy, the patient was admitted to hospital with a large haematoma in the abdominal muscles. Factor VIII level was zero and inhibitor titer was 345 Bethesda units. Oral immunosuppressive therapy with methylprednisolone and cyclophosphamide was administered for 1 month, with limited improvement. Therefore, cyclophosphamide was replaced by a four once-weekly dose of intravenous rituximab. Two months later, factor VIII level was normal and inhibitor titer was undetectable. Conclusion: Rituximab may be useful for the treatment of acquired haemophilia resistant to standard therapy (AU)

Antecedentes: la hemofilia adquirida es un trastorno infrecuente causado por el desarrollo de inhibidores del factor de coagulación. Para eliminarlos, se requiere tratamiento con corticoides y fármacos citotóxicos. Métodos: Describimos el caso del uso de rituximab en hemofilia adquirida refractaria al tratamiento convencional en un hombre de 63 años con infección crónica por el virus de la hepatitis C y que estaba recibiendo tratamiento con interferón pegilado α-2a y ribarivina. Resultados: Tras 21 semanas de tratamiento antivírico, el paciente fue ingresado en el hospital por un gran hematoma en la musculatura abdominal. La concentración de factor VIII era nula y el título de inhibidor fue de 345 unidades Bethesda. Se administró tratamiento inmunosupresor oral con metilprednisolona y ciclofosfamida durante 1 mes, con escasa mejoría. Así pues, se sustituyó la ciclofosfamida por una dosis semanal de rituximab intravenoso. Dos meses después, la concentración de factor VIII se normalizó y el título de inhibidor era indetectable. Conclusión: Rituximab puede ser útil en el tratamiento de la hemofilia adquirida resistente al tratamiento estándar (AU)

Acquired haemophilia A in a patient with chronic hepatitis C virus infection receiving treatment with pegylated interferon plus ribarivin: role of rituximab.

BACKGROUND: Acquired haemophilia is an uncommon condition caused by the development of clotting factor inhibitors. To eliminate them, immunosuppressive therapy with corticosteroids and cytotoxic drugs is required. METHODS: We describe a case of rituximab use in acquired haemophilia refractory to conventional therapy in a 63 year old male patient with chronic hepatitis C virus infection who was receiving treatment with pegylated-interferon-a-2a plus ribavirin. RESULTS: After 21 weeks of antiviral therapy, the patient was admitted to hospital with a large haematoma in the abdominal muscles. Factor VIII level was zero and inhibitor titer was 345 Bethesda units. Oral immunosuppressive therapy with methylprednisolone and cyclophosphamide was administered for 1 month, with limited improvement. Therefore, cyclophosphamide was replaced by a four once-weekly dose of intravenous rituximab. Two months later, factor VIII level was normal and inhibitor titer was undetectable. CONCLUSION: Rituximab may be useful for the treatment of acquired haemophilia resistant to standard therapy.

Antecedentes: la hemofilia adquirida es un trastorno infrecuente causado por el desarrollo de inhibidores del factor de coagulación. Para eliminarlos, se requiere tratamiento con corticoides y fármacos citotóxicos. Métodos: describimos el caso del uso de rituximab en hemofilia adquirida refractaria al tratamiento convencional en un hombre de 63 años con infección crónica por el virus de la hepatitis C y que estaba recibiendo tratamiento con interferón pegilado a-2a y ribarivina. Resultados: tras 21 semanas de tratamiento antivírico, el paciente fue ingresado en el hospital por un gran hematoma en la musculatura abdominal. La concentración de factor VIII era nula y el título de inhibidor fue de 345 unidades Bethesda. Se administró tratamiento inmunosupresor oral con metilprednisolona y ciclofosfamida durante 1 mes, con escasa mejoría. Así pues, se sustituyó la ciclofosfamida por una dosis semanal de rituximab intravenoso. Dos meses después, la concentración de factor VIII se normalizó y el título de inhibidor era indetectable. Conclusión: Rituximab puede ser útil en el tratamiento de la hemofilia adquirida resistente al tratamiento estándar.