Incidencia de la enfermedad inflamatoria intestinal y fenotipo al diagnóstico en 2011: resultados del estudio Epi-IBD 2011 en el área de Vigo / Incidence of inflammatory bowel disease and phenotype at diagnosis in 2011: results of the Epi-IBD 2011 study in the Vigo area

Objetivo: validar la incidencia de la enfermedad inflamatoria intestinal (EII) descrita en el área de Vigo en 2010 en el seno del estudio Epi-IBD, la más alta comunicada en España hasta esa fecha.Métodos: estudio prospectivo, de cohortes incidentes y base poblacional. Se incluyeron todos los pacientes diagnosticados de EII entre el 1-1-2011 y el 31-12-2011 en el área de Vigo.Resultados: se diagnosticaron 100 casos (62 % hombres, edad media de 43,27 años): 49 de colitis ulcerosa (CU), 34 de enfermedad de Crohn (EC) y 17 de EII no clasificada (EIINC). La incidencia (por 100.000 habitantes/año) de la EII fue de 17.56 (EC: 5,97; CU: 8,60; EIINC: 2,98), similar a la descrita en 2010. En la población no pediátrica fue de 19.66 (EC: 6,89; CU: 9,52; EIINC: 3,04). El fenotipo de la EC y la CU fue similar en 2010 y 2011.Conclusiones: este estudio confirma la alta tasa de incidencia de la EII descrita en el área de Vigo en 2010. (AU)

Incidence of inflammatory bowel disease and phenotype at diagnosis in 2011: results of the Epi-IBD 2011 study in the Vigo area.

OBJECTIVE: to validate the incidence of inflammatory bowel disease (IBD) reported in Vigo in 2010 within the Epi-IBD study, which was the highest incidence reported so far in Spain. METHODS: an epidemiological, prospective, population-based inception cohort study. All incident cases of IBD living in the Vigo area at diagnosis from January 1 to December 31, 2011 were included. RESULTS: one hundred patients were diagnosed (62 % men; median age, 43.27 years): 49 with ulcerative colitis (UC), 34 with Crohn's disease (CD), and 17 with IBD unclassified (IBDU). The incidence (per 100,000 inhabitants/year) was 17.56 (CD: 5.97; UC: 8.60; IBDU: 2.98), similar to that reported in 2010. The incidence in the non-pediatric population was 19.66 (CD: 6.89, UC: 9.52; IBDU: 3.04). CD and UC phenotype was similar in 2010 and 2011. CONCLUSION: this study supports the increased incidence of EII in the Vigo area reported in 2010.

Valoración de la adhesión terapéutica en la enfermedad inflamatoria intestinal. Comparación entre una escala de autoevaluación y un índice farmacéutico de dispensación de medicamentos / Assessing medication adherence in inflammatory bowel diseases. A comparison between a self-administered scale and a pharmacy refill index

Introducción: la falta de adhesión terapéutica en la enfermedad inflamatoria intestinal (EII) tiene un impacto negativo en el control de la enfermedad. Existen diferentes herramientas para evaluar la falta de adhesión. Nuestro objetivo fue comparar una escala de autoevaluación con un índice de posesión de medicación, e identificar los factores relacionados con falta de adhesión. Métodos: solicitamos a pacientes ambulatorios con EII inactiva que rellenasen los cuestionarios de adhesión MMAS-8 y de opiniones sobre medicación BMQ. Revisamos los registros de dispensación farmacéutica en los 3-6 meses anteriores calculando el índice de posesión de medicación (MPR). Consideramos no adhesión terapéutica valores de MMAS-8 < 6 y MPR < 0,8, respectivamente. Resultados: incluimos a 203 pacientes (60% colitis ulcerosa, 40% enfermedad de Crohn), 51% varones, edad 46,3 (14) años. Un 74% empleaba monoterapia y un 26%, terapia combinada; el 65% recibía mesalazina, el 46% tiopurinas y el 16% fármacos anti-TNF. La no adhesión fue 37% evaluada con MPR y 22,4% con MMAS-8. El área bajo la curva ROC del valor 6 de MMAS-8 fue 0,6 (IC 95%: 0,5-0,7, p = 0,001). Esta puntuación mostró una sensibilidad del 85% y una especificidad del 34% para predecir no adhesión terapéutica, con valores predictivos negativos y positivos del 57 y 70% respectivamente. Las puntuaciones altas en la subescala de daño del cuestionario BMQ se asociaron a no adhesión en MPR (p = 0,01). Conclusión: la precisión de MMAS-8 para identificar falta de adhesión en pacientes con EII inactiva en nuestro entorno es pobre dada su baja especificidad y valor predictivo negativo. Las opiniones sobre la medicación parecen estar relacionadas con la adhesión terapéutica en EII (AU)

Background: Medication non-adherence in inflammatory bowel disease (IBD) has a negative impact on disease outcome. Different tools have been proposed to assess non-adherence. We aimed to compare a self-administered scale and a pharmacy refill index as a reliable measure of medication adherence and to determine what factors are related to adherence. Methods: Consecutive non-active IBD outpatients were asked to fill in the self-reported Morisky Medication Adherence Scale (MMAS-8) and the Beliefs about Medication Questionnaire (BMQ). Pharmacy refill data were reviewed from the previous three or six months and the medication possession ratio (MPR) was calculated. Non-adherence was defined as MMAS-8 scores < 6 or MPR < 0.8. Results: Two-hundred and three patients were enrolled (60% ulcerative colitis, 40% Crohn’s disease); 51% were men, and the mean age was 46.3 (14) years. Seventy-four per cent of patients were on monotherapy and 26% on combination therapy; altogether, 65% received mesalazine, 46% thiopurines and 16% anti-tumor necrosis factor alfa. Non-adherence rate assessed by MPR was 37% and 22.4% by MMAS-8. Receiver operator curve analysis using a MMAS-8 cut-off of six gave an area under the curve of 0.6 (95% CI 0.5-0.7), p = 0.001. This score had an 85% sensitivity and 34% specificity to predict medication non-adherence, with negative and positive predictive values of 57% and 70% respectively. High scores in the BMQ potential for harm of medication were significantly associated with MPR non-adherence (p = 0.01). Conclusion: The accuracy of MMAS-8 to identify medication non-adherence in inactive IBD outpatients in our setting is poor due to a low specificity and a negative predictive value. Psychosocial factors such as beliefs about medication seem to be related to IBD non-adherence (AU)

Assessing medication adherence in inflammatory bowel diseases. A comparison between a self-administered scale and a pharmacy refill index.

BACKGROUND: Medication non-adherence in inflammatory bowel disease (IBD) has a negative impact on disease outcome. Different tools have been proposed to assess non-adherence. We aimed to compare a self-administered scale and a pharmacy refill index as a reliable measure of medication adherence and to determine what factors are related to adherence. METHODS: Consecutive non-active IBD outpatients were asked to fill in the self-reported Morisky Medication Adherence Scale (MMAS-8) and the Beliefs about Medication Questionnaire (BMQ). Pharmacy refill data were reviewed from the previous three or six months and the medication possession ratio (MPR) was calculated. Non-adherence was defined as MMAS-8 scores < 6 or MPR < 0.8. RESULTS: Two-hundred and three patients were enrolled (60% ulcerative colitis, 40% Crohn's disease); 51% were men, and the mean age was 46.3 (14) years. Seventy-four per cent of patients were on monotherapy and 26% on combination therapy; altogether, 65% received mesalazine, 46% thiopurines and 16% anti-tumor necrosis factor alfa. Non-adherence rate assessed by MPR was 37% and 22.4% by MMAS-8. Receiver operator curve analysis using a MMAS-8 cut-off of six gave an area under the curve of 0.6 (95% CI 0.5-0.7), p = 0.001. This score had an 85% sensitivity and 34% specificity to predict medication non-adherence, with negative and positive predictive values of 57% and 70% respectively. High scores in the BMQ potential for harm of medication were significantly associated with MPR non-adherence (p = 0.01). CONCLUSION: The accuracy of MMAS-8 to identify medication non-adherence in inactive IBD outpatients in our setting is poor due to a low specificity and a negative predictive value. Psychosocial factors such as beliefs about medication seem to be related to IBD non-adherence.

European experience with methotrexate treatment in Crohn's disease: a multicenter retrospective analysis.

INTRODUCTION: Methotrexate (MTX) has been utilized for the treatment of Crohn's disease (CD) for decades. Nevertheless, current data provide equivocal evidence on the efficacy of MTX in CD.The aims of this study were to describe the efficacy of MTX for maintenance of remission in CD and to identify the factors associated with the probability of steroid-free clinical remission in a multicenter European referral center cohort. PATIENTS AND METHODS: This was a retrospective cohort analysis. Consecutive patients treated with MTX for CD were included from 11 referral centers. Patients receiving concomitant treatment with tumor necrosis factor inhibitors or thiopurines were excluded. The main outcome was steroid-free clinical remission; the secondary outcomes included the rate of complications leading to MTX discontinuation and duration of relapse-free survival in patients achieving the main outcome. RESULTS: Between July 1992 and January 2012, 118 patients were identified for inclusion. MTX administration route was oral for induction in 31.4% and for maintenance in 49.1% of the patients. Steroid-free remission was achieved in 44/118 (37.2%) patients and was maintained relapse free by 28/44 (63.6%) for a median of 12 (3.5-18.5) months. At least one adverse effect was reported by 28.9% of the patients. No clinical or demographic factors were associated with either likelihood of achieving a clinical response or duration of relapse-free survival. CONCLUSION: MTX treatment induced steroid-free clinical remission in over a third of CD patients and maintained it for a year in almost two-thirds of the responders. MTX should be considered a viable therapeutic option in CD patients refractory to other therapies.

Incidence and phenotype at diagnosis of inflammatory bowel disease. Results in Spain of the EpiCom study / Incidencia y fenotipo al diagnóstico en la enfermedad inflamatoria intestinal. Resultados del estudio EpiCom en España

INTRODUCTION: Incidence of inflammatory bowel disease (IBD) is increasing progressively. Few recent epidemiological prospective studies are available in Spain. The Epicom study, a population-based inception cohort of unselected IBD patients developed within the European Crohn's and Colitis Organization, was started in 2010. Vigo is the only Spanish area participating. OBJECTIVE: To describe the incidence of IBD in the Vigo area and the phenotypical characteristics at diagnosis and to compare them with previous data available in Spain. MATERIAL AND METHODS: Epidemiological, descriptive, prospective, and population-based study. All incident cases of IBD during 2010 and living in the Vigo area at diagnosis were included. The Copenhagen Diagnostic criteria were used to define cases. Background population at the start of the study was 579,632 inhabitants. Data were prospectively entered in the EpiCom database. RESULTS: A total of 106 patients were included (57.5% men, median age 39.5 years). Of them 53 were diagnosed of as Crohn's disease (CD), 47 ulcerative colitis (UC) and six IBD unclassified (IBDU). The incidence rate per 100,000 per year for patients aged 15 years or older was 21.4 (10.8 for CD, 9.4 for UC, 1.2 IBDU). Including pediatric population incidence rates were 18.3 (10.3 CD, 8.7 UC, 1.2 IBDU). Median time since onset of symptoms until diagnosis was 2 months. CONCLUSIONS: The incidence rate of IBD in Vigo is the highest compared to former Spanish cohorts, especially in CD patients. Median time since onset of symptoms until diagnosis is relatively short

INTRODUCCIÓN: La incidencia de la enfermedad inflamatoria intestinal (EII) va paulatinamente en aumento. En España escasean los estudios epidemiológicos prospectivos recientes. En 2010 se inició el estudio Epicom, un estudio demográfico de cohortes de inicio de pacientes con EII no seleccionados que se desarrolla en el marco de la Organización Europea de Enfermedad de Crohn y Colitis Ulcerosa. La de Vigo es la única zona española participante. OBJETIVO: Describir la incidencia de la EII en el área de Vigo y las características fenotípicas en el momento del diagnóstico y compararlas con los datos previos disponibles sobre España. MATERIAL Y MÉTODOS: Estudio epidemiológico, descriptivo, prospectivo y demográfico. Se incluyeron todos los casos de EII incidentes durante el año 2010 en residentes de la zona de Vigo. Para definir los casos se emplearon los criterios diagnósticos de Copenhague. La población del entorno al inicio del estudio era de 579.632 habitantes. Los datos se incluyeron en la base de datos EpiCom de manera prospectiva. RESULTADOS: Se incluyó un total de 106 pacientes (57,5% varones, mediana de edad de 39,5 años). De ellos, 53 fueron diagnosticados con enfermedad de Crohn (EC), 47 con colitis ulcerosa (CU) y 6 con EII no clasificado (EIINC). La tasa de incidencia anual por 100.000 para pacientes de 15 años o más fue de 21,4 (10,8 para EC; 9,4 para CU; 1,2 para EIINC). Si se incluye la población pediátrica, la tasa de incidencia fue de 18,3 (10,3 para EC; 8,7 para CU; 1,2 para EIINC). La mediana de tiempo para la aparición de los síntomas hasta el diagnóstico fue de 2 meses.CONCLUSIONES: La tasa de incidencia de la EII en Vigo es la más alta en comparación con antiguas cohortes españolas, sobre todo en el caso de los pacientes con EC. La mediana de tiempo para la aparición de los síntomas hasta el diagnóstico es relativamente breve

Incidence and phenotype at diagnosis of inflammatory bowel disease. Results in Spain of the EpiCom study.

INTRODUCTION: Incidence of inflammatory bowel disease (IBD) is increasing progressively. Few recent epidemiological prospective studies are available in Spain. The Epicom study, a population-based inception cohort of unselected IBD patients developed within the European Crohn's and Colitis Organization, was started in 2010. Vigo is the only Spanish area participating. OBJECTIVE: To describe the incidence of IBD in the Vigo area and the phenotypical characteristics at diagnosis and to compare them with previous data available in Spain. MATERIAL AND METHODS: Epidemiological, descriptive, prospective, and population-based study. All incident cases of IBD during 2010 and living in the Vigo area at diagnosis were included. The Copenhagen Diagnostic criteria were used to define cases. Background population at the start of the study was 579,632 inhabitants. Data were prospectively entered in the EpiCom database. RESULTS: A total of 106 patients were included (57.5% men, median age 39.5 years). Of them 53 were diagnosed of as Crohn's disease (CD), 47 ulcerative colitis (UC) and six IBD unclassified (IBDU). The incidence rate per 100,000 per year for patients aged 15 years or older was 21.4 (10.8 for CD, 9.4 for UC, 1.2 IBDU). Including pediatric population incidence rates were 18.3 (10.3 CD, 8.7 UC, 1.2 IBDU). Median time since onset of symptoms until diagnosis was 2 months. CONCLUSIONS: The incidence rate of IBD in Vigo is the highest compared to former Spanish cohorts, especially in CD patients. Median time since onset of symptoms until diagnosis is relatively short.

Delphi consensus statement: Quality Indicators for Inflammatory Bowel Disease Comprehensive Care Units.

BACKGROUND AND AIMS: While it is commonly accepted that Inflammatory bowel disease (IBD) Comprehensive Care Units (ICCUs) facilitate the delivery of quality care to Crohn's disease and ulcerative colitis patients, it remains unclear how an ICCU should be defined or evaluated. The aim of the present study was to develop a comprehensive set of Quality Indicators (QIs) of structure, process, and outcomes for defining and evaluating an ICCU. METHODS: A Delphi consensus-based approach with a standardized three-step process was used to identify a core set of QIs. The process included an exhaustive search using complementary approaches to identify potential QIs, and two Delphi voting rounds to select the QIs defining the core requirements for an ICCU. RESULTS: The consensus selected a core set of 56 QIs (12 structure, 20 process and 24 outcome). Structure and process QIs highlighted the need for multidisciplinary management and continuity of care. The minimal IBD team should include an IBD nurse, gastroenterologists, radiologists, surgeons, endoscopists and stoma management specialists. ICCUs should be able to provide both outpatient and inpatient care and admission should not break the continuity of care. Outcome QIs focused on the adequate prophylaxis of disease complication and drug adverse events, the need to monitor appropriateness of treatment and the need to reinforce patient autonomy by providing adequate information and facilitating the patients' participation in their own care. CONCLUSIONS: The present Delphi consensus identified a set of core QIs that may be useful for evaluating and certifying ICCUs.