Concordance between expectations and preferences of patients and evaluation criteria of the European Medicines Agency.

OBJECTIVE: The European Medicines Agency's marketing authorisation criteria  for drugs are reflected in the European Public Assessment Reports. The  objective is to describe the expectations and preferences of our  oncohematological outpatients with respect to their oral treatments, and to  evaluate the concordance with the results of European Public Assessment Reports. METHOD: A survey of onco-hematological patients' expectations and preferences about overall survival and quality of life was developed, with three items: expectations on treatment, preferences of benefit and  willingness to receive novel treatments with non-definitive results. European  Public Assessment Reports of the indicated drugs were reviewed. Kappa index  (κ) was used to assess the agreement between patients' expectations  and preferences respect to the benefit in overall survival and quality of life  described in the corresponding European Public Assessment Report.  Concordance between willingness of patients to receive novel treatments and European Public Assessment Reports results was evaluated by absolute  agreement (Ao). RESULTS: There were 29 participants, and 19 different European Public Assessment Reports were consulted. Patients' expectations about their  treatment: 82.1% expected improvement in overall survival and quality of life; the κ value between expectations and results of European Public Assessment Reports was 0.091 (confidence interval 95%: -0.025 to 0.207). Patients' preferences about benefit of their treatment: 92.6%  preferred quality of life; the κ value was 0.016 (confidence interval 95%: - 0.127 to 0.160). Willingness to receive novel treatments: 82.1% participants demanded benefit in overall survival or quality of life; exigences were met in Ao = 53.6% of patients. CONCLUSIONS: Little agreement was observed between expectations and  preferences of our onco-hematological patients and European Public Assessment Reports, according to overall survival and quality of life.  Most patients preferred an improvement in quality of life, but also expected  an  increase in overall survival with their treatment. Almost half of  patients would not meet their requirements to receive their drug when it was  authorized.

OBJETIVO: Los criterios de autorización de comercialización de medicamentos de la Agencia Europea del Medicamento se reflejan en los European Public Assessment Reports. El objetivo es describir las  expectativas y preferencias de nuestros pacientes externos oncohematológicos con respecto a sus tratamientos orales, y evaluar la  concordancia con los resultados de los European Public Assessment Reports. Método: Se elaboró una encuesta sobre las expectativas y preferencias de los  pacientes oncohematológicos respecto a la supervivencia global y calidad de  vida, con tres ítems: expectativas sobre el tratamiento, preferencias de  beneficio y disposición a recibir tratamientos novedosos con resultados  inmaduros. Se revisaron los European Public Assessment Reports de los  fármacos indicados. Se utilizó el índice kappa (κ) para evaluar la concordancia  entre las expectativas y preferencias de los pacientes respecto al beneficio en  supervivencia global y calidad de vida descrito en el European Public  Assessment Report correspondiente. La concordancia entre la disposición de  los pacientes a recibir nuevos tratamientos y los resultados de los European  Public Assessment Reports se evaluó mediante la concordancia absoluta (Ao). RESULTADOS: Se incluyeron 29 participantes y se consultaron 19 European Public Assessment Reports diferentes. Expectativas de los pacientes sobre su tratamiento: el 82,1% esperaba una mejora de la  supervivencia global y calidad de vida; el valor κ entre las expectativas y los  resultados de los European Public Assessment Reports fue de 0,091 (intervalo  de confianza 95%: ­0,025 a 0,207). Preferencias de los pacientes sobre el beneficio de su tratamiento: el 92,6% prefirió la calidad de vida; el valor κ fue de 0,016 (intervalo de confianza 95%: ­0,127 a 0,160). Disposición a  recibir tratamientos novedosos: el 82,1% de los participantes exigió un beneficio en la supervivencia global o en la calidad de vida; las exigencias se cumplieron en Ao = 53,6% de los pacientes. CONCLUSIONES: Se observó poca concordancia entre las expectativas y  preferencias de nuestros pacientes oncohematológicos y los European Public  Assessment Reports, según la supervivencia global y la calidad de vida. La  mayoría de los pacientes preferían una mejora de la calidad de vida, pero  también esperaban un aumento de la supervivencia global con su tratamiento.  Casi la mitad de los pacientes no cumpliría con sus requisitos para recibir su  medicación cuando ésta fuera autorizada.

Concordancia entre las expectativas y preferencias de los pacientes y los criterios de evaluación de la Agencia Europea del Medicamento / Concordance between expectations and preferences of patients and evaluation criteria of the European Medicines Agency

Objetivo: Los criterios de autorización de comercialización de medicamentosde la Agencia Europea del Medicamento se reflejan en losEuropean Public Assessment Reports. El objetivo es describir las expectativasy preferencias de nuestros pacientes externos oncohematológicoscon respecto a sus tratamientos orales, y evaluar la concordancia con losresultados de los European Public Assessment Reports.Método: Se elaboró una encuesta sobre las expectativas y preferenciasde los pacientes oncohematológicos respecto a la supervivencia globaly calidad de vida, con tres ítems: expectativas sobre el tratamiento, preferenciasde beneficio y disposición a recibir tratamientos novedosos conresultados inmaduros. Se revisaron los European Public Assessment Reportsde los fármacos indicados. Se utilizó el índice kappa (κ) para evaluar laconcordancia entre las expectativas y preferencias de los pacientes respectoal beneficio en supervivencia global y calidad de vida descrito enel European Public Assessment Report correspondiente. La concordanciaentre la disposición de los pacientes a recibir nuevos tratamientos y losresultados de los European Public Assessment Reports se evaluó mediantela concordancia absoluta (Ao). Resultados: Se incluyeron 29 participantes y se consultaron 19 EuropeanPublic Assessment Reports diferentes.

Objective: The European Medicines Agency’s marketing authorisationcriteria for drugs are reflected in the European Public Assessment Reports.The objective is to describe the expectations and preferences of our oncohematologicaloutpatients with respect to their oral treatments, and toevaluate the concordance with the results of European Public AssessmentReports.Method: A survey of onco-hematological patients’ expectations andpreferences about overall survival and quality of life was developed, withthree items: expectations on treatment, preferences of benefit and willingnessto receive novel treatments with non-definitive results. European PublicAssessment Reports of the indicated drugs were reviewed. Kappa index(κ) was used to assess the agreement between patients’ expectations andpreferences respect to the benefit in overall survival and quality of lifedescribed in the corresponding European Public Assessment Report. Concordancebetween willingness of patients to receive novel treatments andEuropean Public Assessment Reports results was evaluated by absoluteagreement (Ao). Results: There were 29 participants, and 19 different European PublicAssessment Reports were consulted. Patients’ expectations about theirtreatment: 82.1% expected improvement in overall survival and qualityof life; the κ value between expectations and results of European PublicAssessment Reports was 0.091 (confidence interval 95%: –0.025 to0.207). Patients’ preferences about benefit of their treatment: 92.6% preferredquality of life; the κ value was 0.016 (confidence interval 95%:–0.127 to 0.160). Willingness to receive novel treatments: 82.1% participantsdemanded benefit in overall survival or quality of life; exigenceswere met in Ao = 53.6% of patients.

Implantación de la Guía de buenas prácticas en prevención de lesiones por presión: desarrollo, resultados y sostenibilidad / Implementation of the best practice guideline for pressure ulcer prevention: Development, results and sustainability

OBJETIVO: Evaluar el impacto de la implantación de la guía «Valoración del riesgo y prevención de úlceras por presión» sobre la adherencia a las recomendaciones de la guía, la prevalencia de lesiones por presión (LPP) y sostenibilidad de los resultados, así como analizar las estrategias de implantación, la sostenibilidad y las barreras detectadas. MÉTODO: Estudio observacional retrospectivo (de junio del 2015 a diciembre del 2018). Se estudiaron 2periodos (P1: preparación y P2: sostenibilidad). Se analizaron las memorias del programa y los datos de la historia clínica de pacientes dados de alta en los 4hospitales participantes sobre la adherencia de las recomendaciones preventivas y los resultados en salud en términos de presencia de LPP por cada centro. RESULTADOS: Se incluyó a 13.515 pacientes, de los cuales 4.523 tenían riesgo de LPP y 722 tenían LPP. El 82,9% de los pacientes recibieron una valoración del riesgo de LPP al ingreso. Se observó una disminución de esta valoración al ingreso: P1: 89,1% vs. P2: 81%; p < 0,001. El 42,1% de los pacientes de riesgo fueron reevaluados durante el ingreso, observándose un aumento significativo entre los períodos: P1: 30,7% vs. P2: 46%; p < 0,001. El 63,2% contaba con una superficie especial de manejo de presión, con un aumento significativo: P1: 55,3% vs. P2: 65%; p < 0,001. La prevalencia global de LPP fue del 5,5%, observándose una disminución significativa al comparar P1: 6,6% vs. P2: 5,1%; p = 0,003. La prevalencia de LPP nosocomiales fue del 2,1%, manteniéndose constante P1: 2% y P2: 2,1%; p = 0,708. El compromiso institucional, la designación de líderes, elaboración de planes de acción y la formación son estrategias destacables en todos los centros. CONCLUSIONES: El presente estudio muestra la existencia de una adecuada adherencia a las principales recomendaciones de la guía, observándose una mejoría estadísticamente significativa en la adherencia a 2 de las 3 recomendaciones evaluadas. Las estrategias de implantación y sostenibilidad puestas en marcha han contribuido en el mantenimiento o mejora de los resultados en el tiempo

AIM: To assess the impact of implementing the "Risk Assessment and Prevention of Pressure Injuries (PI)" guideline on adherence to its recommendations, the prevalence of PI and the sustainability of results, and to analyse the implementation strategies, sustainability and barriers detected. METHODS: A retrospective observational study (June 2015 to December 2018). Two periods were studied (P1: Preparation and P2: Sustainability). The programme reports and data from the medical records of patients discharged from the 4participating hospitals were analysed with regard to adherence to preventive recommendations and health outcomes in terms of the presence of pressure injuries per centre. RESULTS: A total of 13,515 patients were included, of whom 4,523 were at risk for PI and 722 had PI. Of the patients, 82.9% underwent a risk assessment for PI on admission. A decrease in this assessment on admission was observed between P1:89.1% vs. P2: 81% P<.001. Of the patients at risk, 42.1% were reassessed during their admission and a significant increase was observed between the periods P1: 30.7% vs. P2:46%; P<.001. 63.2% had a special pressure management surface, with a significant increase between P1:55.3% vs. P2: 65%; P<.001. The overall prevalence of PI was 5.5% and a significant decrease was observed on comparing P1: 6.6% vs. P2:5.1%; P=.003. The prevalence of nosocomial PI remained constant at 2.1%, P1:2% and P2:2.1%; P=.708. Institutional commitment, the appointment of leaders, drawing up of action plans, and training are outstanding strategies in all the centres. CONCLUSIONS: This study shows that there is adequate adherence to the main recommendations of the guideline. A statistically significant improvement was observed in adherence to 2 out of the 3 recommendations assessed. The implantation and sustainability strategies implemented have been contributed to maintenance and/or improving results over time

Implementation of the best practice guideline for pressure ulcer prevention: Development, results and sustainability. / Implantación de la Guía de buenas prácticas en prevención de lesiones por presión: desarrollo, resultados y sostenibilidad.

AIM: To assess the impact of implementing the "Risk Assessment and Prevention of Pressure Injuries (PI)" guideline on adherence to its recommendations, the prevalence of PI and the sustainability of results, and to analyse the implementation strategies, sustainability and barriers detected. METHODS: A retrospective observational study (June 2015 to December 2018). Two periods were studied (P1: Preparation and P2: Sustainability). The programme reports and data from the medical records of patients discharged from the 4participating hospitals were analysed with regard to adherence to preventive recommendations and health outcomes in terms of the presence of pressure injuries per centre. RESULTS: A total of 13,515 patients were included, of whom 4,523 were at risk for PI and 722 had PI. Of the patients, 82.9% underwent a risk assessment for PI on admission. A decrease in this assessment on admission was observed between P1:89.1% vs. P2: 81% P<.001. Of the patients at risk, 42.1% were reassessed during their admission and a significant increase was observed between the periods P1: 30.7% vs. P2:46%; P<.001. 63.2% had a special pressure management surface, with a significant increase between P1:55.3% vs. P2: 65%; P<.001. The overall prevalence of PI was 5.5% and a significant decrease was observed on comparing P1: 6.6% vs. P2:5.1%; P=.003. The prevalence of nosocomial PI remained constant at 2.1%, P1:2% and P2:2.1%; P=.708. Institutional commitment, the appointment of leaders, drawing up of action plans, and training are outstanding strategies in all the centres. CONCLUSIONS: This study shows that there is adequate adherence to the main recommendations of the guideline. A statistically significant improvement was observed in adherence to 2 out of the 3 recommendations assessed. The implantation and sustainability strategies implemented have been contributed to maintenance and/or improving results over time.