Traducción al español y validación de un cuestionario breve de medida del control de la enfermedad inflamatoria intestinal desde la perspectiva del paciente: IBD-Control, EII-Control / Translation into Spanish and validation of a short questionnaire to measure the control of inflammatory bowel disease from the patient's perspective: IBD-Control, EII-Control

Objetivo: La medida de los resultados percibidos por el paciente en la asistencia de la enfermedad inflamatoria intestinal (EII) adquiere cada vez más importancia. Existe una herramienta sencilla y validada en inglés para este fin: el «IBD-Control». Nuestro objetivo es traducirlo al español, adaptarlo y validarlo.Pacientes y métodos: Se tradujo el IBD-Control, generando el instrumento en español «EII-Control», y se validó prospectivamente. Los pacientes cumplimentaban el EII-Control y otros cuestionarios que servían de comparadores de referencia. El gastroenterólogo realizaba una valoración global de la enfermedad, calculaba índices de actividad y registraba el tratamiento. Un subgrupo de pacientes repitió toda la valoración en una segunda visita. Se analizó también la utilidad de escalas resumidas del EII-Control (el EII-Control-8 y el EII-Control-EVA). Resultados: Se incluyeron 249 pacientes con EII (101 repitieron la segunda visita). Estándares psicométricos del test: consistencia interna: α de Cronbach para EII-Control 0,83 con fuerte correlación entre EII-Control-8 y EII-Control-EVA (r=0,5); reproducibilidad: correlación intraclase 0,70 para EII-Control; validez de constructo: correlaciones de moderadas a fuertes entre EII-Control, EII-Control-8 y EII-Control-EVA frente a comparadores; validez discriminante: p <0,001; sensibilidad al cambio: misma respuesta que índice de calidad de vida. Sensibilidad y especificidad en el punto de corte 14 de 0,696 y 0,903, respectivamente, para determinar el estado quiescente. Conclusiones: El EII-Control es un instrumento válido para medir el control de la EII desde la perspectiva del paciente en nuestro medio y cultura. Su simplicidad lo convierte en una herramienta útil para apoyar la asistencia.(AU)

Objective: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the “IBD-Control”. Our aim is to translate it into Spanish, adapt and validate it. Patients and methods: The IBD-Control was translated into the Spanish instrument “EII-Control” and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed. Results: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status. Conclusions: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.(AU)

Impact of the lockdown period due to the COVID-19 pandemic in patients with inflammatory bowel disease / Impacto del confinamiento debido a la pandemia por COVID-19 en pacientes con enfermedad inflamatoria intestinal

Introduction: The lockdown period due to the coronavirus disease 2019 (COVID-19) in Spain probably had a significant emotional impact on chronic patients and hence on those who are suffering from inflammatory bowel disease (IBD) due to their high risk of emotional disorders. The aim of this study was to learn how COVID-19 influenced patients suffering from IBD during the quarantine period, focusing in particular on psychological distress through the Perceived Stress Scale-10 (PSS-10) and also the impact of the pandemic on therapeutic adherence using the Visual Analogue Scale (VAS).Patients and methods: A prospective, single-centre and analytical observational study was carried out in the IBD unit in August 2020. Patients were contacted and interviewed by phone. A descriptive analysis was carried out and subsequently the factors associated with the loss of therapeutic adherence and higher-moderate levels of stress were analyzed through logistic regression multivariate analyses.Results: A total of 426 patients were included with a median PSS-10 score of 12 (10–16). A higher level of stress was reported by those who were not married, women and those who experienced an increase in IBD-related symptoms. Adherence to treatment was not associated with stress based on the PSS-10 questionnaire.Conclusions: Although the lockdown period due to the COVID-19 pandemic has probably had a significant emotional impact on Spaniards with IBD, IBD patients in general had lower PSS-10 scores.

Introducción: El confinamiento debido a la pandemia por COVID-19 en España tuvo probablemente un importante impacto emocional en los pacientes crónicos, y por tanto en aquellos que sufren enfermedad inflamatoria intestinal (EII) debido a su riesgo incrementado de padecer desórdenes emocionales. El objetivo de este estudio es el de conocer como la COVID-19 ha influido a los pacientes con EII durante el período de cuarentena, haciendo hincapié en el nivel de estrés a través de la Escala de Estrés Percibido (PSS-10) así como en la adherencia a los tratamientos por medio de la escala visual analógica (VAS).Pacientes y métodos: Estudio prospectivo, unicéntrico y observacional realizado en la Unidad de EII durante el mes de agosto de 2020. Los pacientes fueron entrevistados por teléfono. Se llevó a cabo un análisis descriptivo inicial, posteriormente se identificaron los factores relacionados con la pérdida de adherencia, así como con los niveles altos-moderados de estrés a través de análisis de regresión logística multivariante.Resultados: Fueron incluidos un total de 426 pacientes con una puntuación media en la escala PSS-10 de 12 (10-16). Los niveles más altos de estrés se reportaron en aquellos pacientes que no estaban casados, las mujeres o aquellos que habían incrementado sintomatología relacionada con su EII. La adherencia al tratamiento no se asoció con el nivel de estrés basado en el cuestionario PSS-10.Conclusiones: A pesar de que el período de cuarentena por COVID-19 haya podido tener un importante papel en el impacto emocional de la población española con EII, los pacientes con EII tuvieron en general niveles bajos según el cuestionario PSS-10.

Translation into Spanish and validation of a short questionnaire to measure the control of inflammatory bowel disease from the patient's perspective: IBD-Control, EII-Control. / Traducción al español y validación de un cuestionario breve de medida del control de la enfermedad inflamatoria intestinal desde la perspectiva del paciente: IBD-Control, EII-Control.

OBJECTIVE: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the "IBD-Control". Our aim is to translate it into Spanish, adapt and validate it. PATIENTS AND METHODS: The IBD-Control was translated into the Spanish instrument "EII-Control" and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed. RESULTS: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status. CONCLUSIONS: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.

Impact of the lockdown period due to the COVID-19 pandemic in patients with inflammatory bowel disease.

INTRODUCTION: The lockdown period due to the coronavirus disease 2019 (COVID-19) in Spain probably had a significant emotional impact on chronic patients and hence on those who are suffering from inflammatory bowel disease (IBD) due to their high risk of emotional disorders. The aim of this study was to learn how COVID-19 influenced patients suffering from IBD during the quarantine period, focusing in particular on psychological distress through the Perceived Stress Scale-10 (PSS-10) and also the impact of the pandemic on therapeutic adherence using the Visual Analogue Scale (VAS). PATIENTS AND METHODS: A prospective, single-centre and analytical observational study was carried out in the IBD unit in August 2020. Patients were contacted and interviewed by phone. A descriptive analysis was carried out and subsequently the factors associated with the loss of therapeutic adherence and higher-moderate levels of stress were analyzed through logistic regression multivariate analyses. RESULTS: A total of 426 patients were included with a median PSS-10 score of 12 (10-16). A higher level of stress was reported by those who were not married, women and those who experienced an increase in IBD-related symptoms. Adherence to treatment was not associated with stress based on the PSS-10 questionnaire. CONCLUSIONS: Although the lockdown period due to the COVID-19 pandemic has probably had a significant emotional impact on Spaniards with IBD, IBD patients in general had lower PSS-10 scores.

Eficacia y seguridad de ustekinumab en la práctica clínica real. Estudio multicéntrico retrospectivo. Cohorte ARAINF / Efficacy and safety of ustekinumab in real clinical practice. Retrospective multicentre study. ARAINF cohort

INTRODUCCIÓN: Ustekinumab, anticuerpo monoclonal que bloquea las interleucinas 12/23, ha demostrado en ensayos clínicos su eficacia para inducir y mantener la remisión clínica en la enfermedad de Crohn (EC). Su efectividad y su seguridad en la práctica clínica real es menos conocida y podría diferir respecto a los ensayos. OBJETIVO: Evaluar en la práctica clínica su efectividad y seguridad (pauta de inducción intravenosa esencialmente), como inducción y a largo plazo, en pacientes con EC refractarios a tratamiento biológico. MATERIAL Y MÉTODOS: Análisis retrospectivo multicéntrico (6 hospitales aragoneses), que incluye a todos los pacientes (N=69) con EC en tratamiento con ustekinumab (fuese con inducción intravenosa o subcutánea) que hubiesen alcanzado al menos 16 semanas de seguimiento. La respuesta o remisión clínica se ha evaluado en las semanas 16, 24, 32 y 48 mediante el índice de Harvey-Bradshaw. RESULTADOS: Se han incluido un total de 69 pacientes, edad media 42 años, 54% hombres. Un 89,86% (IC 95% [0,805, 0,949]) de los pacientes ha presentado mejoría clínica en la semana 16 (15,95% remisión, 73,92% respuesta). En el seguimiento posterior dicha respuesta se ha mantenido. Se han identificado mediante un modelo de regresión ordinal la edad (OR 0,95, p = 0.028) y el hábito tabáquico (OR 0,19, p = 0,027) como predictores de mala respuesta al tratamiento, mientras que la necesidad de cambio de biológico por efecto adverso (OR 96, p = 0,00017) y por pérdida de respuesta secundaria (OR 7,07, p = 0,034) han sido factores predictores de buena respuesta. No se han reportado efectos adversos graves que obligasen a interrumpir el tratamiento con ustekinumab. CONCLUSIÓN: Ustekinumab es efectivo y seguro en la práctica clínica real para lograr la inducción y el mantenimiento de la respuesta en pacientes con EC refractaria. El tabaco y la edad han mostrado ser predictores de mala respuesta, mientras que la indicación por efecto adverso a biológico previo y por pérdida de respuesta secundaria han mostrado ser predictores de buena respuesta

INTRODUCTION: Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. OBJECTIVE: To evaluate its effectiveness and safety in clinical practice (intravenous induction pattern essentially), such as induction and over the long term, in patients with CD refractory to biological treatment. MATERIAL AND METHODS: Multicentre retrospective analysis (6 hospitals in Aragón), which includes all patients (N=69) with CD undergoing treatment with ustekinumab (either with intravenous or subcutaneous induction), who had at least 16 weeks of follow-up. The clinical response or remission has been evaluated at weeks 16, 24, 32 and 48 using the Harvey-Bradshaw index. RESULTS: A total of 69 patients have been included, mean age 42 years, 54% men. A percentage of 89.86 (95% CI [0.805, 0.949]) of the patients presented clinical improvement at week 16 (15.95% remission, 73.92% response). In the subsequent follow-up, this response has been maintained. Age (OR 0.95, P=.028) and smoking habits (OR 0.19, P=.027) have been identified by an ordinal regression model as predictors of poor treatment response while the need for biological change due to adverse effect (OR 96, P=.00017) and due to loss of secondary response (OR 7.07, P=.034) have been predictors of good response. No serious adverse effects have been reported that forced them to stop taking ustekinumab. CONCLUSION: Ustekinumab is effective and safe in real clinical practice to achieve induction and maintenance of the response in patients with refractory CD. Tobacco and age have been shown to be predictors of poor response, while the indication for adverse effect to previous biological and for loss of secondary response has been shown to be predictors of good response

Efficacy and safety of ustekinumab in real clinical practice. Retrospective multicentre study. ARAINF cohort. / Eficacia y seguridad de ustekinumab en la práctica clínica real. Estudio multicéntrico retrospectivo. Cohorte ARAINF.

INTRODUCTION: Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. OBJECTIVE: To evaluate its effectiveness and safety in clinical practice (intravenous induction pattern essentially), such as induction and over the long term, in patients with CD refractory to biological treatment. MATERIAL AND METHODS: Multicentre retrospective analysis (6 hospitals in Aragón), which includes all patients (N=69) with CD undergoing treatment with ustekinumab (either with intravenous or subcutaneous induction), who had at least 16 weeks of follow-up. The clinical response or remission has been evaluated at weeks 16, 24, 32 and 48 using the Harvey-Bradshaw index. RESULTS: A total of 69 patients have been included, mean age 42 years, 54% men. A percentage of 89.86 (95% CI [0.805, 0.949]) of the patients presented clinical improvement at week 16 (15.95% remission, 73.92% response). In the subsequent follow-up, this response has been maintained. Age (OR 0.95, P=.028) and smoking habits (OR 0.19, P=.027) have been identified by an ordinal regression model as predictors of poor treatment response while the need for biological change due to adverse effect (OR 96, P=.00017) and due to loss of secondary response (OR 7.07, P=.034) have been predictors of good response. No serious adverse effects have been reported that forced them to stop taking ustekinumab. CONCLUSION: Ustekinumab is effective and safe in real clinical practice to achieve induction and maintenance of the response in patients with refractory CD. Tobacco and age have been shown to be predictors of poor response, while the indication for adverse effect to previous biological and for loss of secondary response has been shown to be predictors of good response.

Use of agents stimulating erythropoiesis in digestive diseases.

Anemia is the most common complication of inflammatory bowel disease (IBD). Control and inadequate treatment leads to a worse quality of life and increased morbidity and hospitalization. Blood loss, and to a lesser extent, malabsorption of iron are the main causes of iron deficiency in IBD. There is also a variable component of anemia related to chronic inflammation. The anemia of chronic renal failure has been treated for many years with recombinant human erythropoietin (rHuEPO), which significantly improves quality of life and survival. Subsequently, rHuEPO has been used progressively in other conditions that occur with anemia of chronic processes such as cancer, rheumatoid arthritis or IBD, and anemia associated with the treatment of hepatitis C virus. Erythropoietic agents complete the range of available therapeutic options for treatment of anemia associated with IBD, which begins by treating the basis of the inflammatory disease, along with intravenous iron therapy as first choice. In cases of resistance to treatment with iron, combined therapy with erythropoietic agents aims to achieve near-normal levels of hemoglobin/hematocrit (11-12 g/dL). New formulations of intravenous iron (iron carboxymaltose) and the new generation of erythropoietic agents (darbepoetin and continuous erythropoietin receptor activator) will allow better dosing with the same efficacy and safety.