An Innovative Decision Support System for diagnosis and treatment of IBD patients Evaggelos E. Karvounis*, Vasileios E. Tsianos*, Kallirroi S. Kyriakidi*, Epameinondas V. Tsianos*,** * Research Laboratory of Hepato-Gastroenterology, Division of Gastroenterology, Faculty of Medical School of Health Sciences, University of Ioannina ** 1st Division of Internal Medicine and Division of Gastroenterology, Faculty of Medical School of Health Sciences, University of Ioannina This research project has been co-financed by the European Union (European Regional Development Fund- ERDF) and Greek national funds through the Operational Program “THESSALY-MAINLAND GREECE AND EPIRUS - 2007-2013” of the National Strategic Reference Framework (NSRF 20072013) What is IBD? • Inflammatory Bowel Disease (IBD) involves chronic inflammation of all or part of the digestive tract. • IBD primarily includes ulcerative colitis and Crohn’s disease. – Ulcerative colitis is a type of inflammatory bowel disease that causes inflammations in the colon. • Symptoms include abdominal pain and diarrhea, sometimes bloody. – Crohn’s disease is another type of IBD that causes inflammation of the lining of the digestive tract. In CD, inflammation often spreads deep into affected tissues. • The inflammation can involve different areas of the digestive tract : the large intestine, small intestine or both, and/or upper GI tract. The impact of IBD in society • The IBD is regarded to represent a multifactorial disease where genetic factors are interacting with environmental factors. • The aetiology of IBD still remains unknown. • The combined use of lifestyle surveys associated with blood samples and relevant clinical registers seems the best methodology to identify possible links between genetic predisposition, disease occurrence and natural course. All that obviously leads to high financial charges to health services and implies clear reflection on life quality parameters for the patients and the society. Our GOAL • • • • • • To extent the data collection process Digital recording of clinical data Genetic analysis Serum analysis of blood samples Collection of all available data Efficient analysis using Knowledge Extraction and Data Mining techniques • To understand the natural course of the disease, study predisposing factors and genes and determine early predictors of outcome and response to treatment techniques. How can we achieve this goal? We create an innovative clinical DSS, an efficient web-based platform, which incorporates 2 modules: A Data Repository module: Centralized data repository for annotation data (clinical, demographic and experimental data), sample source and handling information, processing and quality assurance information, as well as inventory and process flow data. Knowledge Discovery/Statistics module: Provide tracking, data query, report generation, process management functions, data handling as well as statistics, data mining and knowledge extraction capability. Moreover, the module will contain a Data Representation module that will handle the presentation of the extracted knowledge from the patients’ data. Flow chart system Ι. DATA COLLECTION / BIOBANK DECISION SUPPORT SYSTEM ΙΙ. DATA RECORDING Environmental Data Clinical-laboratory tests Biological Samples Blood Collection Collection and storage of tissue samples DNA Extraction Serum Extraction Gene Study Serological Study Recording of the Results Knowledge Database ΙΙΙ. DATA ANALYSIS Export of New Knowledge and Association Rules Statistical Analysis Data Repository module • A SQL Server database has already been developed along with the 1st version of the platform. • Medical data from almost 600 old patients, using their hard-copy medical records, have been digitized. • Blood sampling has accomplished in 294 new patients and 234 healthy volunteers. • The results of the gene and serological study are recorded in the database. Data Repository module Personal information Patient's History Family History History of the Disease Medication Lab Tests • Name • Sex • Date of Birth • Surgeries • Infections • Associated Diseases • Family History for IBD • Family History for Other Diseases • Family History for Cancer • Established Disease • Length of CD/UC • Clinical Assessment • 5-ASA • Steroids • Anti-TNFs • ASCA • pANCA Codify digital data Insert data in the database (system) Train the system Data Repository module A) Old patients • Collection of old Patient Medical Records (files) (~ 600) • Digitization of medical records into electronic files • Design and implementation of Data Base System (SQL SERVER 2012) • Copying data to the System Database Data Repository module B) New patients • Collection and reporting of clinical-laboratory data from patients with IBD (so far has been collected biological material from 294 patients with IBD and 234 healthy controls). • Blood sampling after signed informed consent of each patient. • Bio-samples are processed in the lab (serum, DNA extraction). • Encoding based on the disease: ◦ Crohn's disease (CD), ◦ Ulcerative colitis (UC), ◦ Indeterminate colitis (IC) • Storage in -80˚C freezer for further laboratory analysis (gene / serological study). Data Repository module B) New patients Along with the sample collection, began the initial experimental procedure with the first laboratory experiments for the "standardization" of methodology. Experimental procedure Our research team is studying variable polymorphisms of genes and serum biomarkers which, according to the bibliography, seems to be associated (correlate) with IBD. Knowledge Discovery/Statistics module • The Web application has already been developed. • Several knowledge discovery techniques have been applied in the Databases, giving more than satisfactory results. Scenarios These scenarios present some possible interactions between the user and the system: Shows the probability of a surgery need Displays the most appropriate treatment for each individual patient Recommends modifications/ changes of the treatment plan for an individual patient Shows probability exacerbations in the disease process Shows probability recession disease Displays the possible extent of the disease Shows the probability of occurrence of extra-intestinal manifestations Progress Phase 1: Defining user requirements, protocol and system design Phase 2: Development of individual components of the system Phase 3: Integration and Clinical Evaluation System Phase 4: Project management and dissemination of results Phase 1 2 3 4 2013 2014 2015 July AugustSeptember October November December JanuaryFebruary MarchApril May June July AugustSeptember October November December JanuaryFebruary MarchApril May June July AugustSeptember October Future (possible) Cooperation This system is a decision support system that aims to be a handy tool for the physician. In order this system, to provide us the data we need, it has to be sufficiently (well) trained. A large volume of information has to be inserted. Need of cooperation!!! The MORE DATA we get, the SAFER RESULTS we provide! Conclusions - Benefits and expansion options • The implementation of the proposed project will bring profits not only to IBD patients (avoiding side effects) but also significant economic benefits to the health system. • Furthermore, the development of a predictive model for IBD, can promote research and proper management of patients in other health areas except gastroenterology. Safeguarding the rights of such a program would bring direct benefits in University of Ioannina as already many organizations and research groups are interested in developing such a prediction model. • Through this knowledge, we can easily move to personalized treatment, bearing in mind there are no diseases, but only patients. Thank you for your attention!!! Contact Information ekarvuni@cc.uoi.gr vtsianos@cc.uoi.gr kkyriak@cc.uoi.gr