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)

Self-expandable metal stents versus endoscopic balloon dilation for the treatment of strictures in Crohn's disease (ProtDilat study): an open-label, multicentre, randomised trial.

BACKGROUND: Endoscopic balloon dilation (EBD) is the established endoscopic treatment for short strictures in Crohn's disease. Fully covered self-expandable metal stents (FCSEMS) have been used for endoscopic treatment of patients for whom EBD was unsuccessful. We aimed to determine the efficacy and safety of the two endoscopic treatments in patients with Crohn's disease with stenosis and compare the mean cost of both treatments. METHODS: This multicentre, open-label, randomised trial was done in 19 tertiary and secondary hospitals in Spain. Patients with Crohn's disease with obstructive symptoms and predominantly fibrotic strictures of less than 10 cm in length were eligible for inclusion. We excluded patients with stenosis treated with SEMS or EBD in the previous year and stenosis not accessible to a colonoscope. Patients were randomly assigned (1:1) to receive either EBD (EBD group) or FCSEMS (FCSEMS group) using a digital en-block randomisation system (block size of four). In the EBD group, dilation was done with a CRE Boston Scientific (Marlborough, MA, USA) pneumatic balloon with the diameter set at the discretion of the endoscopist; a maximum of two sessions of dilation were allowed with a minimum interval of 15-30 days between them. In the FCSEMS group, a 20 mm diameter Taewoong (Gimpo-si, South Korea) fully covered metal stent was placed; stent length was set at the discretion of the endoscopist. The primary outcome was to assess the efficacy of the endoscopic treatment, defined by the proportion of patients free of a new therapeutic intervention (EBD, FCSEMS, or surgery) due to symptomatic recurrence at 1 year of follow-up. Patients were analysed according to the intention-to-treat principle. Adverse events were recorded for all the patients; events were considered associated to be with the procedure when a causal association was possible, probable, or definite. This trial is registered with ClinicalTrials.gov, NCT02395354. FINDINGS: From Aug 28, 2013, to Oct 9, 2017, we assessed the eligibility of 99 patients, of whom 19 (19%) patients were excluded. Thus, 80 (81%) patients were randomly assigned to treatment: 39 (49%) patients to the FCSEMS group and 41 (51%) patients to the EBD group. 33 (80%) of 41 patients in the EBD group and 20 (51%) of 39 patients in the FCSEMS group were free of a new therapeutic intervention at 1 year (odds ratio [OR] 3·9 [95% CI 1·4-10·6]; p=0·0061). Two (3%) of 80 patients had severe adverse events (one [2%] patient in the EBD group and one [3%] patient in the FCSEMS group); both patients had perforations. INTERPRETATION: EBD is more effective than FCSEMS for Crohn's disease strictures, with a good safety profile for both treatments. FUNDING: Spanish National Institute of Health, Foundation of Spanish Society of Digestive Endoscopy, Catalan Society of Gastroenterology, and Taweoong.

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)

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.