| Background and purpose As people’s life rhythm speeding up and the increase of stress at work, Functional Gastrointestinal Disorders (FGIDs) incidence tended to rise further, and the prevalence of Functional Gastrointestinal diseases in different regions population was different, such as Functional dyspepsia prevalence was 7%-41%, and the prevalence of irritable bowel syndrome was 5% 25%. The prevalence of FGIDs was at a high level in our country. Considering the huge population base in China, the number of FGIDs patients was significantly higher than other countries. And in other departments, such as Cardiology, pneumology and psychology, outpatients with FGIDs occupied a certain proportion. FGIDs pathophysiological mechanism is very complicated, covering gastrointestinal movement dysfunction, increased visceral sensitivity, Hp infection, gastrointestinal hormone disorders, psychosocial factors, stress, eating habits and life styles. The pathogenesis of FGIDs was not clear yet, while the long term treating effect was still unsatisfied, that further in-depth study of the disease was needed, including the epidemiological investigation, the selection of treatment and follow-up for therapeutic effect, clinical studies of new drugs, etc. Create an online FGIDs database, collecting a large number of FGIDs patients data to constitute a large sample database, had an important value on the research of the disease.Method According to the Rome Ⅲ criteria and the characteristics of FGIDS,we designed and made the case report form (CRF) to collect specific cases of FGIDs. The CRF includes general information, clinical symptoms, the psychological status, living habits, eating habits, medical history, examination results, clinical diagnosis, methods and period of treatments, treatment effect, etc.:1. General information and data:name, gender, blood type, nationality, date of birth, age at diagnosis, contact information, etc.2. The clinical symptoms:32 symptoms of digestive system were designed referring to Rome III standard. We Recorded the symptoms, frequency, duration and the relationship between the symptoms and diets, exercise or defecation. Past medical history included 16 diseases which might be associated with functional gastrointestinal disorders. Recording symptoms and duration of above items.3. The psychological condition, included workload, life pressure, history of adverse events, a history of childhood abuse, and personality traits.4. Habits included smoking habits, liquor drinking habits, tea drinking habits, exercise habit, daily sitting time and sleeping time. Smoking habit included time, frequency, and every day quantity; Liquor drinking habits included the type of liquor, first-time-age, frequency and daily amount; Tea drinking habits including the frequency, tea species; Exercise habits included intensity, frequency and the everytime duration.5. Daily diet habits included the amounts of staple food, meat, vegetables, fruits, milk and water and time cost for a meal.6. Examinations included gastroscopy, colonoscopy, gastrointestinal angiography, electrocardiogram (ecg), abdominal ultrasonic inspection, motility detection, esophageal pressure, esophageal PH impedance, psychological testing, enteroscope, capsule endoscopy and CT.7. Diagnosis of functional gastrointestinal disorders, as well as peptic ulcer, inflammatory bowel disease and normal people as control.8.Treatment methods and effect record, included the choice of drug and treatment course. Drug types included acid inhibitors, prokinetics, antispasmodic, bromo, anxiolytics, probiotics, mucosa protectant, antidiarrheal, gastrointestinal function regulator, laxatives, proprietary Chinese medicine. Each type contained several commonly used drugs. Treatment effect was set five options for follow-up patients to choose:cure, remarkable, better, worse, invalid.9. Statistic analysis function of the database system can be divided into three parts: (1) basic statistics:statistics in the overall number of cases and proportions of different diagnosis; Overall treatment effect;(2)cases characteristics statistics: showing the relationship between the proportion of each diagnosis and the general situation, the symptoms, psychological characteristics and lifestyle;(3) the treatment effect and the influence factors:statistical relationship between different general characters, psychological characteristics, lifestyle, drug selection and collocation methods, combining Chinese and western medicine, treatment course and treatment effect. Statistical results were displayed in the tabular form as well as in bar chart form. Statistical charts and tables were available online, and output as EXEL files for further analysis.10. Retrieval:this database system could make the necessary auxiliary retrieval according to age, gender, diagnosis, etc.System which using the MySQL database, was developed by the IDE (integrated development environment) program:Visual Studio. System with B/S (browser/server) mode supported the Internet access. The system in general could be divided into three layers:application layer, logic layer, database layer. The application layer was responsible for the human-computer interaction function, including web request, web content display, the user input processing; Logic layer was responsible for data processing, data computing, encryption, call interface; Data layer was responsible for establishing connection with database, data query, and returning the query results. Application of the system structure, guaranteed the security of the database, that the database could be presented through the network and increase cases or update information at any time. It could be more easy to achieve the statistical analysis of data and maintenance, and realize the sharing of data.Database system is set up the function of statistical analysis, which can be divided into three parts:(1) basic statistics:statistics of the number and proportion in the overall number of cases with each diagnosis; (2) the characteristic statistics:the relationship between the proportion of cases with each diagnosis and the general situation, the symptoms, psychological characteristics, lifestyle and so on; (3) the treatment effect and the influence factors:relationship between different general situation, psychological characteristics, lifestyle, drug selection, collocation methods, combining Chinese and western medicine and treatment effect. Statistical results were not only showed as the tabular form, but displayed in a bar chart graphically. Statistical charts and tables could be output online as EXEL files for further analysis.The database system was set up with the searching function that cases could be searched according the names, genders, diagnosis and so on.Result A functional gastrointestinal disease medical records database system including general information, clinical symptoms, psychological state, living habits, eating habits, medical history, examination results, clinical diagnosis, treatment methods and treatment, treatment effect, data statistics and analysis was formed. FGIDs cases in our hospital from July 2013 strictly following Rome III criteria were collected. The database collected complete data including general information, diagnosis methods, treatment, treatment time, factors probably in relation to diagnosis or treatment, follow-up results and treatment results. It also could searching data by age, gender, diagnosis, treatment or treatment results solely or multiply. It possessed statistic function especially to find out the cause of the disease, the age distribution, influencing factors, the option and judgment of treatment methods and time, etc.Discussion At present our country is still lack of functional gastrointestinal disease clinical case database. Our team collected data by the CRF form well standardized, created the background language, establish the widely covered, greatly practical functional gastrointestinal disease network database following the requirements step by step in order to obtain the representative case data, standardize management of functional gastrointestinal disease cases data and realize data sharing. This database system contains functional gastrointestinal disease and results of digestive endoscope, ultrasonic inspection, X-ray inspection. We also recorded the possible factors associated with the onset of disease, such as psychological characteristics, diet, living habits and so on in order to obtain more comprehensive characteristics of functional gastrointestinal disease cases. Effective treatment method for functional gastrointestinal disease was not clear, when traditional Chinese medicine was often used in the clinical practice. Chinese medicine as well as some other herbs were shown effective in some studies. The database system recorded the use of different kinds of western medicine, Chinese medicine and the treatment effect of different treatment options to evaluate objectively the effects of western medicine and Chinese medicine in the treatment of functional gastrointestinal disease. Statistic function was set up in the database, which could analyze the characteristics of cases, treatment effect and influence factors. It also provided the basic statistics and FGIDS epidemiological investigation, to form the foundation of clinical diagnosis and treatment norms.Modern medicine pay more and more attention to disease information management. The number of different kinds of clinical case database increased year by year, especially for the diagnosis and treatment of unclear common diseases. Clinical case database was built to find the special performance of disease, diagnosis methods and measures to improve the prognosis, different treatment options and their curative effect and the side effects of various treatment and so on. As human understanding of disease changed, social and economic status, psychological characteristics, family situation, diet, smoking and drinking habits of life, the living environment or territorial, microbial and chemical exposure also became the research point of diagnosis and treatment for unclear diseases. The establishment of the clinical case database could make the specific clinical data gathered together, and to expand clinical research and epidemiological investigation data, which was very important to medical research. Medical institutions nationwide held the medical records of specific diseases, but not convenient to share information among institutions. In the rapid developing network era, clinical case database system not only can be combined with medical institutions of the electronic medical record system, at the same time can browse, search and operate it through the Internet to update at once. Gathering the clinical data to expand the data volume could make the clinical studies more reliable. In addition, to establish a well designed common data elements would ensure the consistency of data, and it would be a trend to properly modify according to the different countries on the basis of special circumstances such as different languages, different ethnic habits and customs.Conlusion Functional gastrointestinal disease database and case report form were in line with the standard, and the large volume of database also meet the requirements of the scientific research, which could be expanded gradually and promoted to other hospitals. Database system could search for specific data conveniently, as well as analyse the epidemiology, diagnosis methods, treatment selection, treatment results and influencing factors, providing evidence for clinical studies and lying the foundation of treatment for the disease. |
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