847034 research-article20192019 TAG0010.1177/1756284819847034Therapeutic Advances in GastroenterologyM Chaparro, M Barreiro-de Acosta Therapeutic Advances in Gastroenterology Study Protocol EpidemIBD: rationale and design of a Ther Adv Gastroenterol 2019, Vol. 12: 1–11 large-scale epidemiological study of DOI: 10.1177/ https://doi.org/10.1177/1756284819847034 https://doi.org/10.1177/1756284819847034 1756284819847034 inflammatory bowel disease in Spain © The Author(s), 2019. Article reuse guidelines: sagepub.com/journals- permissions María Chaparro , Manuel Barreiro-de Acosta, José Manuel Benítez, José Luis Cabriada, María José Casanova, Daniel Ceballos, María Esteve, Hipólito Fernández, Daniel Ginard, Fernando Gomollón, Rufo Lorente, Pilar Nos, Sabino Riestra, Montserrat Rivero, Pilar Robledo, Cristina Rodríguez, Beatriz Sicilia, Emilio Torrella, Ana Garre, Correspondence to: Esther García-Esquinas, Fernando Rodríguez-Artalejo and Javier P. Gisbert, on behalf María Chaparro Inflammatory Bowel of the EpidemIBD study group of GETECCU Diseases Unit, Department of Gastroenterology, Hospital Universitario de Abstract La Princesa, Instituto de Investigación Sanitaria Background: Inflammatory bowel disease (IBD) is associated with a considerable burden Princesa (IIS-IP), Universidad Autónoma to the patient and society. However, current data on IBD incidence and burden are limited de Madrid, and Centro de because of the paucity of nationwide epidemiological studies, heterogeneous designs, and a Investigación Biomédica en Red de Enfermedades low number of participating centers and sample size. The EpidemIBD study is a large-scale Hepáticas y Digestivas investigation to provide an accurate assessment of the incidence of IBD in Spain, as well as (CIBERehd), Diego de León, 62, Madrid, 28006, Spain treatment patterns and outcomes. mariachs2005@gmail.com Methods: This multicenter, population-based incidence cohort study included patients Manuel Barreiro-de Acosta aged >18 years with IBD (Crohn’s disease, ulcerative colitis, or unclassified IBD) diagnosed Gastrointestinal Units of Complexo Hospitalario during 2017 in 108 hospitals in Spain, covering 50% of the Spanish population. Each Universitario de Santiago, participating patient will attend 10 clinic visits during 5 years of follow up. Demographic data, Santiago de Compostela, A Coruña, Spain IBD characteristics and family history, complications, treatments, surgeries, and hospital José Manuel Benítez admissions will be recorded. Gastrointestinal Units of Hospital Universitario Results: The EpidemIBD study is the first large-scale nationwide study to investigate the Reina Sofía and IMIBIC, incidence of IBD in Spain. Enrollment is now completed and 3627 patients are currently being Córdoba, Spain José Luis Cabriada followed up. Gastrointestinal Units of Conclusions: The study has been designed to overcome many of the limitations of previous Hospital de Galdakao- Usansolo, Galdakao, European studies into IBD incidence by prospectively recruiting a large number of patients Vizcaya, Spain from all regions of Spain. In addition to epidemiological information about the burden of IBD, María José Casanova Ana Garre the 5-year follow-up period will also provide information on treatment patterns, and the Javier P. Gisbert natural history and financial burden of IBD. Gastrointestinal Units of Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Keywords: epidemiology, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, Princesa (IIS-IP), Universidad Autónoma incidence de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Received: 25 October 2018; revised manuscript accepted: 25 March 2019. Hepáticas y Digestivas (CIBERehd), Madrid, Spain Daniel Ceballos Introduction so IBD often has a significant effect on patients’ Gastrointestinal Units of Hospital Universitario de The relapsing–remitting nature of inflammatory lives at a time when they are completing their edu- Gran Canaria Dr. Negrín, bowel disease (IBD) and its lifelong course make cation, establishing their careers, embarking on Las Palmas de Gran Canaria, Spain this condition one of the most burdensome gastro- intimate relationships, or starting a family.3,4 María Esteve intestinal disorders.1 In fact, in addition to the Gastrointestinal Units financial burden on healthcare systems, IBD has a The incidence of IBD seems to vary widely of Hospital Universitari Mutua Terrassa and significant impact on quality of life.1 Most patients between countries.5 Traditionally, a north-south CIBERehd, Terrassa, with IBD are diagnosed during their 20s or 30s,2 gradient had been reported, so that the diagnosis Barcelona, Spain journals.sagepub.com/home/tag 1 Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Therapeutic Advances in Gastroenterology 12 Hipólito Fernández Gastrointestinal Units of IBD was more frequent in northern than in IBD diagnosis, as well as other methodological dif- of Hospital San Pedro, southern countries.6 More recently, the existence ferences.11 In Europe, there is a paucity of nation- Logroño, Spain of an east-west gradient has been suggested, with wide epidemiological studies, with most of them Daniel Ginard Gastrointestinal Units a higher incidence of IBD in western than eastern being conducted in countries with relatively small of Hospital Universitari countries.7,8 Also there is a higher prevalence of populations in northern or central Europe Son Espases, Palma de Mallorca, Spain IBD in high-income versus low-income countries, (Denmark, Hungary, and Iceland).12–14 Nationwide Fernando Gomollón but the global spread of industrialization has studies are important to enhance representative- Gastrointestinal Units increased the burden of IBD in Asian, South ness and limit the impact of incidence variability of Hospital Clínico Universitario “Lozano American, and Middle Eastern countries that within a country.15 However, even nationwide Blesa”, IIS Aragón and were previously relatively unaffected.9,10 studies can be flawed; for example, those using CIBERehd, Zaragoza, Spain administrative databases may be subject to certain Rufo Lorente Most authors agree, however, that the overall classification bias.11 Many studies (including Gastrointestinal Units incidence of IBD has been increasing during EpiCom) were conducted at a limited number of of Hospital General Universitario de Ciudad recent decades. For example, in a systematic centers within each country,7,16 which may limit Real, Ciudad Real, Spain review of 238 articles on the incidence and 122 generalizability, or used small sample sizes, which Pilar Nos Gastrointestinal Units on the prevalence of IBD, 75% of the studies of reduces the precision of the incidence esti- of Hospital Universitari patients with Crohn’s disease (CD) and 60% of mates.11,15 For example, only one Spanish center i Politecnic La Fe and CIBERehd, Valencia, Spain the studies of patients with ulcerative colitis (UC) was included in the EpiCom study,17 and this Sabino Riestra showed a significant increase of the incidence of center was in Galicia, a region with a known asso- Gastrointestinal Units these diseases over time.5 The annual increase in ciation between CD susceptibility and the pres- of Hospital Universitario Central de Asturias and the incidence ranged from 1% to 23% for CD ence of CARD15 gene mutations.18 Instituto de Investigación and from 2.5% to 18% for UC.5 Another system- Sanitaria del Principado de Asturias (ISPA), Oviedo, atic review that included 147 studies published The studies conducted on the incidence of IBD Spain between 1990 and 2016 concluded that the inci- in Spain are summarized in Supplementary Table Montserrat Rivero dence of CD and UC in the developed countries 1.17,19–45 Most of these studies were carried out Gastrointestinal Units of Hospital Universitario of Europe, North America and Oceania has stabi- more than a decade ago in selected areas and Marqués de Valdecilla and lized and may even be decreasing.10 However, included a small number of patients. Differences IDIVAL, Santander, Spain with improved treatments and growing popula- in IBD incidence between regions have been Pilar Robledo Gastrointestinal Units tions, the prevalence of CD and UC in these reported, with variability between urban and rural of Hospital Universitario countries continues to rise. At the same time, the centers and between inland and coastal areas San Pedro de Alcántara, Cáceres, Spain incidence of IBD in the developing countries of even within a single region.46 Therefore, the Cristina Rodríguez Africa, Asia, and South America is increasing.10 results of these studies, or the EpiCom data for Gastrointestinal Units of Complejo Hospitalario de Spain,17 may not accurately reflect the current Navarra, Pamplona, Spain In Europe, the European Crohn’s and Colitis incidence of IBD in the whole country. Beatriz Sicilia Organisation-Epidemiological Committee (ECCO Gastrointestinal Units of Hospital Universitario de -EpiCom) initiated a study in 2010 to investigate Since IBD is a chronic disease that is diagnosed at Burgos, Burgos, Spain differences in the incidence, disease characteris- a young age and the incidence appears to be Emilio Torrella tics, and therapeutic management of IBD between increasing, the current IBD prevalence in Spain Gastrointestinal Units of Hospital General eastern and western Europe. The EpiCom study might be considerably higher than that reported Universitario J.M. Morales included 1515 cases of IBD diagnosed over 1 year, previously. However, no up-to-date information Meseguer, Murcia, Spain with an overall incidence rate of 15 cases/ about this is available. Thus, the present Esther García-Esquinas Fernando Rodríguez- 100,000 person-years: 5.4 for CD and 8.2 for UC.7 (EpidemIBD) study was designed to address the Artalejo These estimates fall within the range of IBD inci- information gap on the nationwide burden of IBD Department of Preventive Medicine and Public dences in systematic reviews of the European in Spain. Nationwide studies provide a representa- Health, School of Medicine, literature, which report a UC incidence of tive estimate of an outcome, while limiting the Universidad Autónoma de Madrid/IdiPaz and between 0.6 and 57.9/100,000 person-years, and impact of incidence variability within a country. CIBERESP, Madrid, Spain CD incidence of between 0.0 and 15.4/100,000 Data obtained from such studies can inform health person-years.5,10 policy and approaches to disease management. The primary objective of the EpidemIBD study is These previous studies highlight the broad range to measure the incidence of IBD in Spain, a coun- of IBD incidences reported, possibly due to heter- try with almost 50 million people. Secondary aims ogeneous study designs, which may involve study are: (1) to determine the geographical distribution sites, patients selection, denominators to estimate of IBD in Spain; (2) to describe the characteristics population incidence, and protocols or criteria for of patients at the time of IBD diagnosis; (3) to 2 journals.sagepub.com/home/tag M Chaparro, M Barreiro-de Acosta et al. register the use of immunosuppressive treatments but only about 15% of insured individuals do not and biological drugs, surgeries and hospital admis- use the public services concurrently.48 Thus, given sions during the first 5 years after diagnosis of IBD; the severity and relapsing–remitting nature of IBD, and (4) to measure the delay from the onset of it is unlikely that the incidence of IBD is substan- symptoms to diagnosis. At the time of writing, tially underestimated by including only patients patient enrollment has been completed and the seen at public health centers. study is at the follow-up stage. An IBD specialist who is a member of GETECCU (Spanish Working Group on Crohn’s Disease Methods and Ulcerative Colitis) was selected from each of the 17 Autonomous Communities (administra- Study design tive regions) in Spain to serve as the study coordi- EpidemIBD is a multicenter, nationwide, prospec- nator in their region. An initial selection of centers tive, population-based incidence cohort study of was made from the database of health centers of adult patients diagnosed with IBD (CD, UC, or the Ministry of Health, which included 893 cent- unclassified IBD) during 1 year in Spain. In addi- ers in 2016. The regional coordinators completed tion, each incident case is being followed to deter- a questionnaire to determine the feasibility for mine changes in disease phenotype or location, the each center to participate in the study. Initially, need for immunosuppressive and biologic treat- centers that did not have a gastroenterology ser- ments, and the need for hospital admission or sur- vice at their hospital were excluded. Of the cent- gery during the first 5 years after diagnosis. ers that did have such a service, some were excluded because the physicians did not respond to the invitation emails, refused to participate, or Study population the study coordinator together with the principal The study included all incident patients diagnosed investigator considered that it was not possible to with IBD in the 108 study centers between 1 January identify all IBD cases in the hospital reference 2017 and 31 December 2017 (n = 3627). A total of area. After this initial phase, 142 centers were 237 patients from 34 centers were excluded because selected to start the study. Centers that did not these centers could not ensure adherence to study adequately follow the study procedures or ensure procedures. According to recent data, only 3% of the inclusion of all patients diagnosed with IBD incident IBD cases in Europe are diagnosed in chil- in their area were excluded. During the first dren,7 so the study included only patients over 12 months, 34 centers had withdrawn from the 18 years of age. Diagnosis of IBD was based on study; the main reasons were inability to follow Lennard–Jones criteria.47 All patients diagnosed the study protocol and difficulties in including all with IBD were included in the incident cohort and patients with incident IBD. At the time of writ- invited to participate in a 5-year follow-up study. ing, 108 centers continue to be involved in the study (Figure 1), covering a referral area with a Patients were eligible to be included in the IBD population of 21,943,160 inhabitants (approxi- incident cohort if they belonged to the reference mately 50% of Spanish population, which was area of the participating centers. A patient diag- 46,659,302 as of 28 June 2018).49 nosed at one center (e.g. a particular hospital in Madrid) but who was part of the reference popu- The EpidemIBD protocol allowed each center to lation of another center (e.g. a different hospital use the most appropriate procedure to ensure in Madrid) was assigned to their own reference complete identification of incident IBD cases. population (in this example, that of their usual The databases of the endoscopy units and pathol- hospital). ogy departments were also reviewed at all partici- pating sites during the year of enrollment (2017) to detect cases that might not have been identified Recruitment initially. In these instances, the inclusion period This study is being conducted at 108 centers pro- was extended for 6 months, up to 30 June 2018. viding free access to healthcare within the National Health System. In Spain, healthcare is provided Each participating investigator (see Supplementary mostly by public services; about 15% of the Data) was required to confirm the diagnosis at the Spanish population have private health insurance, time of patient inclusion and 3 months later to journals.sagepub.com/home/tag 3 Therapeutic Advances in Gastroenterology 12 Figure 1. Study sites. 4 journals.sagepub.com/home/tag M Chaparro, M Barreiro-de Acosta et al. ensure the correctness of the diagnosis and the phe- one cigarette in the 6 months prior to diagnosis. notypic characteristics of the disease. External Patients were considered ‘ex-smokers’ if they monitoring of incident patients included in the reg- quit smoking at least 6 months before diagnosis. istry is also being performed by the research staff. Patients were considered ‘nonsmokers’ if they never smoked or did so in very small amounts or occasionally.53 Definitions IBD location and phenotype were defined accord- ing to the Montreal classification.50 European Data collection and follow up Crohn's and Colitis Organisation (ECCO) and Study data were collected and managed using an European Society of Gastrointestinal and electronic data capture tool (Research Electronic Abdominal Radiology (ESGAR) Guideline for Data Capture; REDCap),54 which is hosted at Diagnostic Assessment in IBD was used to assess Asociación Española de Gastroenterología (AEG; the extent of disease.51,52 Briefly, in patients with www.aegastro.es), a nonprofit medical society. UC, a colonoscopy was mandatory. Patients with AEG provided this service free of charge, with the CD had to undergo colonoscopy and a cross- aim of promoting investigator-driven research. sectional image examination to assess the pres- REDCap is a secure, web-based application ence of small bowel involvement. In patients with designed to support data capture for research CD and suspicion of perianal disease, magnetic studies that provides the following: (1) an intui- resonance imaging or transanal ultrasound was tive interface for validated data entry; (2) audit performed. Time to diagnosis was defined as the trails for tracking data manipulation and export time from the first medical consultation attended procedures; (3) automated export procedures for by a symptomatic patient to the diagnosis of IBD. seamless data downloads to common statistical Change in phenotype was defined as the appear- packages; and (4) procedures for importing data ance of new lesions not present at diagnosis, after from external sources.54 the initial tests performed to determine disease extent and severity. An emergency surgical proce- Demographic data, family history of IBD, socio- dure was defined as any surgery performed within economic characteristics, IBD type, pattern, and 24 h of admission, while an elective procedure location, and presence of extraintestinal manifes- was that performed after the first day of admis- tations at diagnosis were collected from each sion and by the scheduled (nonemergency) surgi- patient at the time of inclusion in the study. The cal team. occurrence of complications (fistulas, stenoses, abscesses), changes in disease location, treat- For each patient, the type of population center ments for IBD, surgeries for IBD, and hospital (urban or rural) at the patient's birth and at diag- admissions during 5 years after diagnosis will be nosis of IBD were recorded. Whether the popula- also recorded. tion center of origin was considered rural or urban was based on the classification of the National After the patient is included, two other visits will be Statistics Institute (INE) of each municipality. conducted during the first 12 months, followed by a Socioeconomic level was assessed from the visit every 6 months, until 5 years of follow up are patient's educational level (primary or lower, sec- completed. Thus, over the course of the study, the ondary, higher education), occupational status following 10 visits will be conducted (Figure 2): (self-employed, employed, unemployed, retired), professional status (nonsalaried or salaried), and •• Visit 0 (baseline): inclusion of a patient in work hours (full-time or part-time). The number the study and collection of socioeconomic of cohabitants at the patient's home during their data and diagnosis of IBD. childhood (up to 16 years) and at diagnosis of •• Visit 1 (month 3): confirmation of IBD IBD was also recorded. diagnosis and updating of data related to treatment, changes in phenotype, hospital Smoking status was categorized at the time of admissions, and surgery. diagnosis of IBD as ‘nonsmoker’, ‘smoker’, or •• Visit 2 (month 12) to visit 10 (5 years): con- ‘ex-smoker’. Patients were considered ‘smokers’ firmation of IBD diagnosis and updating of if they smoked more than seven cigarettes per data related to treatment, changes in phe- week for at least 6 months and smoked at least notype, hospital admissions, and surgery. journals.sagepub.com/home/tag 5 Therapeutic Advances in Gastroenterology 12 Figure 2. Program of clinic visits over the course of the study. Only the first prescription of each therapeutic drugs, hospital admission, and performance of group will be recorded. When a change in pheno- surgery. type is observed, the phenotype, the complication leading to reclassification of the patient’s pheno- type, and date of occurrence of the complication Ethics will be recorded. The study is being conducted in accordance with the 1964 Declaration of Helsinki and its subse- Hospital admissions that occur during 5 years quent revisions. The study protocol has been after IBD diagnosis will be recorded, including approved by the Ethics Research Committee of the dates of admission and discharge, and the the coordinating hospital (Hospital Universitario cause of admission (related to IBD or not). Data de La Princesa, Madrid, Spain). In accordance will also be collected on surgical procedures per- with the Spanish regulations for observational formed on the patient since the diagnosis of IBD studies, approval from the ethics committees at (including those which led to its diagnosis), the individual cites is not required. All patients pro- indication for surgery, and its date. vided informed written consent to participate. In order to ensure adherence to the hospital visits schedule, investigators at each center will receive Discussion monthly reminders about the patients who are In order to plan healthcare for patients with IBD, expected to attend hospital visits during the it is important to know the current incidence of upcoming month and the information that will IBD, to evaluate the characteristics of patients at need to be collected. In addition, research staff diagnosis, and to analyze their disease course and will regularly review compliance. need for appropriate treatments, mainly in the first years after diagnosis. This information will be provided by the present (EpidemIBD) study. Statistical analysis The reference population (based on estimates A key strength of the EpidemIBD study is the form the National Statistics Office) for the analy- inclusion of a high proportion of the Spanish pop- ses is the population of the catchment areas of the ulation (approximately 50%) from all areas of the participating centers. The incidence rate (number country. Another strength is that patients have of incident cases per 100,000 inhabitants) during been prospectively identified from a range of hos- 1 year will be calculated, using the reference pop- pital settings. While there are a number of IBD ulation as denominator. Also, age-standardized units in Spain, most Spanish hospitals do not have incidence rates adjusted to the European popula- IBD-specific units and patients are usually treated, tion will be calculated.55 depending on the circumstances of each case, by departments with limited training in this subspe- The Kaplan–Meier method will be used to estimate cialty. By including a range of hospitals with and the time course of the use of treatments, hospital without IBD units, the EpidemIBD study will admissions, surgery, and of complications; the dif- assess diagnostic and treatment practices across a ferences between the curves will be assessed with range of settings and will allow comparison of the log-rank test. A Cox regression model will be patient outcomes between settings and regions. used to identify variables associated with the rate of complications, progression to more severe pheno- Another strength of this study is the 5-year follow types, use of immunosuppressive or biological up, that will identify patients diagnosed with CD 6 journals.sagepub.com/home/tag M Chaparro, M Barreiro-de Acosta et al. or UC whose diagnosis, location, or phenotype Acknowledgements change over time.56,57 The 5-year follow up also The authors wish to thank A.G. McNicholl and J. allows for assessment of treatment patterns and Calvo for programming the e-CRF in AEG- outcomes among IBD patients in Spain, and for a REDCap (from the Spanish Association of comparison of findings against those of the previ- Gastroenterology). The authors wish to thank A. ously mentioned EpiCom study, which provides Durán and P. Jiménez for data monitoring. Europe-wide data on the treatment and outcomes Also, the authors would like to thank Georgii in patients with IBD.58–61 Filatov and Catherine Rees of Springer Healthcare Communications who wrote the first and subse- Various studies suggest that the economic burden quent drafts of this manuscript. This medical of IBD is increasing over time, either because of writing assistance was funded by Merck Sharp & drug-associated costs or the greater sophistication Dohme (MSD). MSD had no access to clinical of the diagnostic tests and therapies required by data and was not involved in study design, statis- patients with IBD.62 In Spain, as in several other tical analysis or manuscript preparation. developed countries, universal healthcare coverage is provided by public healthcare services. The Author contributions are as follows: Therefore, the introduction of ever more costly M. Chaparro and J.P. Gisbert designed the study techniques and drugs is causing a dramatic increase and are leading its development. E.G. García- in the public resources devoted to health. This rate Esquinas participated in study design and advised of increase is not sustainable for most developed about methodological issues. M. Barreiro-de countries; therefore, evaluation of diagnostic and Acosta, J.M. Benítez, J.L. Cabriada, M.J. therapeutic interventions in terms of their effi- Casanova, D. Ceballos, M. Esteve, H. Fernández, ciency and cost–benefit ratio is being increasingly D. Ginard, F. Gomollón, R. Lorente, P. Nos, S. required by healthcare authorities. In the case of Riestra, M. Rivero, P. Robledo, C. Rodríguez, B. IBD, which is costly to manage and primarily Sicilia, E. Torrella, A. Garre collaborated with affects young people, the lifelong resource utiliza- the center selection and are coordinating the tion per patient can be considerable. Therefore, for study in each Autonomous Community. All other countries like Spain, it is important to be able to authors contributed to study design and critically accurately identify the incidence and prevalence of revised the protocol, and were involved in patient the condition (for healthcare planning), and to enrolment and follow up. The EpidemIBD group identify ways to optimize management and reduce includes the following list of investigators: A. burden (for maximizing patients’ contribution to Abraldes, J.M. Benítez, M.R. Calderón, R. society). This is particularly important for expen- Camargo, A. Hernández-Martínez, E. Iglesias, E. sive biologic therapies, which must be used wisely Leo, S. Marín, A. Monrobel, A. Núñez, N. Ruiz, to optimize their cost-effectiveness. In this regard, M. Tejada, Y. Torres, M.J. Alcalá, E. Alfambra, better care may be provided at a lower cost if Y. Ber, F. Gomollón, A. Mir, M. Montoro, J.M. patients are treated by physicians specialized in Nerín, E. Peña, R. Vicente, J.M. Duque, R. de their particular disease, which points to further Francisco, A. Mancebo, S. Martínez-González, I. subspecialization as a way forward in the search for Pérez-Martínez, S. Riestra, P. Varela, I. Alonso- efficiency in medical practice. This may only be Abreu, D. Ceballos, N. Cruz, E. Guerra, A. possible through the formation of teams of health- Hernández Camba, L. Kolle, J.M. Marrero, N. care professionals who can provide uniform and Pérez, M. Soler, M. Vela, J.L.F. Forcelledo, M. specific care for these conditions. Data from our Rivero, R. Lorente, C. Verdejo, M. Montealegre, study, which includes both specialist IBD units A.J. Lucendo, O. Roncero, A Bouhmidi, D. and general gastroenterology departments, will Hervías, L. Arias, J. Barrio, L. Fernández-Salazar, provide additional insight into this question. P. Fradejas, A.M. Fuentes, L. Hernández, C. López, L. Mata, C. Piñero, B. Sicilia, M. Sierra, M. Vásquez, M. Aceituno, M. Bautista, X. Conclusion Calvet, M. Esteve, A. Montserrat, J.A. Gómez- The EpidemIBD study will provide important Valero, J. Gordillo, C. Ledezma, L. Lluis, F.J. information about the incidence of IBD in Spain, Martínez-Cerezo, M. Menacho, M. Navarro- as well as about the management of the disease and Llavat, S. Rodríguez, M. Sabat, M.J. Sampedro, its natural history. These data will be a vital bench- E. Sainz, E. Sesé, A. Silva, S. Torra, L. Torrealba, mark for planning future IBD services in Spain. C. Vila, M. Ágreda Chinea, A. Algaba, F. Bermejo, journals.sagepub.com/home/tag 7 Therapeutic Advances in Gastroenterology 12 I. Blázquez, O. Bosch, B. Botella, M.J. Casanova, consultant for, or received research funding from, C. Castaño-Milla, M. Chaparro, R. de Lucas, MSD, Pfizer, Janssen, Takeda and Otsuka Pharma. M. Domínguez-Antonaya, M.G. Donday, A. M. Barreiro-de Acosta has served as a speaker, a Durán, M.L. Galve, L. García, A. Garre, J.P. consultant and advisory board member for, or has Gisbert, I. Guerra, P. Jiménez, B. López-Cauce, received research funding from, MSD, Abbvie, A. López-Sanromán, P. López, I. Marín-Jiménez, Janssen, Pfizer, Kern Pharma, Biogen, Takeda, M.D. Martín-Arranz, A.G. McNicholl, J.A. Olmos, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. V. Opio, J.L. Pérez-Calle, R. Plaza, A. Ponferrada, Falk Pharma, Tillotts Pharma, Chiesi, Gebro E. San Miguel, E. Sánchez, I. Vera-Mendoza, Pharma, Otsuka Pharma-ceutical and Vifor M. Aguas, M. García-Sepulcre, A. Gutiérrez, Pharma. S. Riestra has received honoraria for con- B. Herreros, J.M. Huguet, N. Jiménez, N. Maroto, ference attendance from Janssen, Abbvie, Takeda L. Martí, M. Mínguez, M. Muñoz, P. Navarro, and MSD, financial support for travel and registra- P. Nos, J.J. Ramírez, M. Roldán, L. Pozzati, P. tion to attend conferences from Abbvie, MSD and Robledo, M. Barreiro-de Acosta, I. Bastón-Rey, Janssen, and his research group has received finan- A. Carmona, D. Carpio, E. Castro, B. Crespo, cial grants from MSD, Abbvie and Takeda. M. M.T. Diz-Lois, A. Echarri, J.D. Fernández-de Rivero has served as a speaker, a consultant and Castro, E. Fernández, R. Ferreiro-Iglesias, advisory board member for MSD, Abbvie and V. Hernández, A. López, P. Pérez, M.J. Ruiz, Janssen. M. Esteve acts as a consultant, assessor or P. Vega, M. Calafat, D. Ginard, E. Iyo, M.T. scientific advisor for Abbott, MSD, Tillotts Novella, J. Reyes, C. Rodríguez, V. Royo, Pharma, Pfizer and Takeda and received research A. Sapiña, H. Fernández, M. Fraile, A. García, grants for MSD and Tillotts Pharma. J.P. Gisbert B. Lapeña, S. Revuelta, R. Irisarri, M. Kutz, has served as a speaker, a consultant and advisory Ó. Nantes, C. Rodríguez, S. Rubio, M. board member for, or has received research fund- Vicuña, H. Alonso, J.L. Cabriada, A. Castiella, ing from, MSD, Abbvie, Hospira, Pfizer, Kern I. Galdona, A. Maíz, A.I. Muñagorri Santos, Pharma, Biogen, Takeda, Janssen, Roche, N. Muro, J. Ortiz, N. Otegui, I. Rodríguez-Lago, Celgene, Ferring, Faes Farma, Shire K. Spicakova, E.M. Zapata, L. Zubiaurre, Pharmaceuticals, Dr. Falk Pharma, Tillotts J.M. Castillo-Espinosa, M.C. Martínez Bonil, Pharma, Chiesi, Casen Fleet, Gebro Pharma, C. Martínez Pascual, I. Nicolás, E. Torrella. Otsuka Pharmaceutical, Vifor Pharma. Funding Supplemental material This research has been funded by grants from the Supplemental material for this article is available Instituto de Salud Carlos III (FIS grant online. PI16/01296 and PFI17/00143), a grant from GETECCU and a grant from MSD. Funding ORCID iD agencies had no role in the study design, in the María Chaparro https://orcid.org/0000-0002 writing of this manuscript, or the decision to sub- -9275-4242 mit for publication. Conflict of interest statement M. Chaparro has served as a speaker, or has References received research or education funding from MSD, 1. Dulai PS, Singh S, Ohno-Machado L, et al. Abbvie, Hospira, Pfizer, Takeda, Janssen, Ferring, Population health management for inflammatory Shire Pharmaceuticals, Dr. Falk Pharma, and bowel disease. Gastroenterology 2018; 154: 37–45. Tillotts Pharma. M.J. Casanova has received edu- cation funding from Pfizer, Janssen, MSD, Abbvie, 2. Duricova D, Burisch J, Jess T, et al. Age- Ferring, Faes Farma, and Shire Pharmaceuticals. related differences in presentation and course of F. 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