Introduction
In August 2013, the Chinese Research Hospital Summit commenced in Xi’an. Themed on “integration, transformation, innovation, and development,” the summit provided a platform for research hospitals to discuss theories and exchange experience concerning the construction of research hospitals. Since PLA General Hospital took the lead in building a research hospital in China in 2004, hundreds of hospitals nationwide have joined the trend, and many large general hospitals have set such construction as a strategic development target. Research hospitals, stressing on both quality and content of medical service, aim to improve clinical efficacy continuously through clinical practice and scientific research. Since 2012, during the process of establishing National Traditional Chinese Medicine Clinical Research Base (hereinafter referred to as “Base”), the Hubei Provincial Hospital of Traditional Chinese Medicine (HPHTCM) has been exploring the mode to construct an outpatient clinic for hepatology research [
1]. The HPHTCM shares similar properties with research hospitals and is an effective and successful trial in constructing research hospitals. To establish a “real-world traditional Chinese medicine (TCM) clinical research paradigm,” the Research Hepatology Outpatient Clinic involves clinical research system, health management system, and characteristics diagnosis and treatment system, wherein the clinical research system acts as the priority and core in research hospital construction. This paper discusses the construction of the Standard and Specification Center, Outcome Assessment Center, Clinical Data Center, and real-world medical ethics, which form the clinical research system, to provide experience and reference in research hospital construction.
Construction of shared system-based Standard and Specification Center
Highly structured electronic medical records (EMRs) are crucial for the construction of the National Traditional Chinese Medicine Treatment and Clinical Research Information Sharing System (hereinafter referred to as “Information Sharing System”). The standardization level thereof directly decides whether the shared system can be successfully constructed. Clinical terminology standardization is also necessary to normalize casual and irregular clinical expressions for better data collection and use of the shared system. The Information Sharing System is constructed for clinical research. Therefore, after the system is constructed, the next step is to develop a shared system-based clinical research program, which is important for the meticulousness and preciseness of the results of clinical research.
To effectively manage standardized items, such as structured EMRs, clinical terminology, and clinical research program, the HPHTCM developed a standard and specification management system, which significantly improved the management level.
Study on shared system-based terminology development
During the construction of the Base as an effective support for clinical practice and scientific research on major liver disease entities, a standardized and scientific TCM hepatology terminology must be developed based on the TCM theoretical system.
Basing on a complete and systematic analysis of the editions of Traditional Chinese Internal Medicine published by People’s Medical Publishing House, China Press of Traditional Chinese Medicine, and Shanghai Scientific and Technical Publishers and current national and professional standards and modern literature relating to the clinical practice of liver diseases, the HPHTCM compiled Basic Hepatology Clinical Terminology of TCM, which covers all hepatology clinical terms of TCM. This compilation is in accordance with the principles and requirements on terminology compilation set by the general research group. These terms were applied in EMR templates.
The hepatology clinical terminology of TCM falls into two categories: principal clinical terminologies with 27 subcategories and attribute terminologies with 10 subcategories. The former comprises terms relating to symptoms, signs, other abnormal clinical manifestations, routes of transmission, incentives, TCM etiology, TCM pathogenesis, TCM focus, TCM disease nature, prognosis, disease progress, TCM disease diagnosis, TCM symptom diagnosis, examination results, western medicine disease diagnoses, TCM rules of treatment, TCM therapies, western medicine therapies, Chinese patent medicine, TCM decoction pieces, prescriptions, western medicine, acupoints, treatment outcomes, operational approaches, TCM tongue manifestations, and TCM pulse manifestations; the latter includes terms concerning the degree, factors, characteristics, frequency, time, quantitative changes, nature, classification and staging, focus, and negative symptom judgment of liver diseases.
The innovation of the Basic Hepatology Clinical Terminology of TCM depends on three aspects. First, this innovation adds principal clinical terms relating to routes of transmission according to the characteristics of major liver diseases. Second, basing on research results of the Symptomatology of TCM and clinical data, this innovation accurately defines each standard term, lists synonyms and corresponding disease attributes, such as focus and nature, and explains confusing and synonymous expressions to realize terminology standardization. Third, given the major liver disease entities as examples, this innovation arranges the structures and contents of terms from a dialectical perspective of TCM hepatology, meeting the requirements of TCM syndrome differentiation as stipulated by the State Administration of Traditional Chinese Medicine (SATCM) and conventional diagnosis and treatment practice of the Hepatology Department of HPHTCM.
Study on templates of shared system-based highly structured EMRs
The hepatology generic templates, comprising medical record and paragraph templates, are provided to the hepatology outpatient clinic and inpatient physicians to standardize collected data. In accordance with the Technical Specification for the Clinical Research of Chronic Hepatitis B (Liver Fixity in TCM) (hereinafter referred to as “Technical Specification”), pathogenesis analysis, syndrome, questionnaire, rules of treatment, and reference prescriptions are integrated into disease-syndrome combined templates on the basis of the generic templates, including the admission record and first-progress note templates. Individual templates are then developed by clinicians according to the disease-syndrome combined templates, thus forming a convenient and effective EMR template set. Highly structured EMRs shall meet the requirements of both clinical practice and scientific research to realize the integration thereof.
The Technical Specification constructs highly structured EMR templates featuring disease-syndrome combination and standardized terminology, as well as a corresponding template set. This innovation also realizes the collection of standardized and structured data for the Information Sharing System, particularly the collection of information obtained via four TCM diagnostic methods (observation, auscultation and olfaction, interrogation, and pulse feeling and palpation). Featuring TCM information collection, the Technical Specification is helpful in data mining and analysis.
Study on standard and specification system
This study constructs a standard information management system based on the standards, textbooks, and technical specifications collected for the major disease-entity research conducted by the Base. According to the requirements of the Information Sharing System and clinical practice-scientific research integration, the system is applied to realize the management and use of relevant standard information. According to the content of standard management, the system is divided into five subsystems, namely, standard library management, textbook library management, data element library management, expert library management, and back-stage management. The construction of the system can satisfy the requirements of medical workers and researchers on inquiring basic information, such as terms, templates, and standards of the major disease entities studied by the Base. In using the Information Sharing System or writing research papers with the help thereof, the users can also insert the terms needed at any place through shortcuts. Fig.1 describes the structure and functions of the standard information management system.
Construction of shared system-based Outcome Assessment Center
Clinical intervention assessment mainly includes effectiveness, safety, and health economics assessments. Therefore, the common clinical outcome assessment indexes principally fall into effectiveness, safety, and health economics indexes. Indexes such as patient satisfaction and exploratory outcome defined by researchers out of interest are classified as other indexes.
The biobank is a key part of the Outcome Assessment Center. High-quality clinical samples constitute valuable resources that are significant for fundamental and clinical research of diseases.
The Outcome Assessment Center is responsible for assisting clinicians in developing the outcome assessment scheme and conducting the outcome assessment. Clinicians have been organized to assess the outcomes of the characteristic treatment and internal preparations developed by the Hepatology Department. For example, the effectiveness assessments on applying fructus evodiae on yongquan acupoints to improve sleep and applying xiaozhang powder (distention reduction powder) to treat abdominal distension caused by qi stagnation and damp obstruction were conducted.
From September 2013 to February 2014, 75 chronic hepatitis B patients were selected from the Research Hepatology Outpatient Clinic and the Inpatient Department of HPHTCM to complete the Therapeutic Effect Assessment Form, which comprises the Patient Fact Sheet, general information of the patient, date of initial visit, chief complaint, TCM syndrome integral questionnaire, laboratory examination results, diagnosis results, therapy, time of subsequent visit, therapeutic effect assessment, and therapeutic effect satisfaction.
Construction of shared system-based Clinical Data Center
Data management
Data management is conducted to unify and standardize the content of information in the data center, guide the design and development of the database and relevant management information systems of the data center, support the data exchange and sharing with relevant health service activities and other information resource databases, and establish the construction of the National Traditional Chinese Medicine Data Center.
Data management is focused mainly on methodological research and computer application. A group formed by professional staff specializing in mathematics and statistics assisted by a clinical research professional and a data management professional is responsible for data standard development; application software system, namely, Operation and Maintenance (O&M); data management and service concerning clinical data collection, archiving, modeling, and mining; and stable and normal operation of the data center.
Data application
Data application is a series of processes relating to data processing and presentation, principally data preprocessing, data cleaning, data standardization, data conversion, statistical data analysis, data presentation, data archiving and auditing, and storage of archived data. The Clinical Data Center includes EMRs of 1200 chronic hepatitis B patients hospitalized in HPHTCM from 2002 to 2013 (100 cases each year), which were developed based on the Information Sharing System; 1200 corresponding TCM prescriptions were collected. According to the statistics of the prescriptions obtained through the clinical practice-scientific research integration platform and complex network technologies, 188 types of herbal medicine were used for a total of 18952 times. The five types of herbal medicine primarily used for treating chronic hepatitis B are Poria cocos, herba artemisiae scopariae, Atractylodes macrocephala Koidz, Salvia miltiorrhiza, and Curcuma, which were used for 687, 585, 547, 488, and 407 times, respectively. These herbs were used in 57.25%, 48.75%, 45.58%, 40.67%, and 33.92% of the prescriptions, correspondingly. The top 20 primarily used herbal medicines are Poria cocos, herba artemisiae scopariae, A. macrocephala Koidz, S. miltiorrhiza, Curcuma, Oldenlandia diffusa, phillyrin, malt, radix glycyrrhizae, Pinellia ternata, pericarpium citri reticulatae, rice sprouts, Bupleurum, radix scutellariae, plantain, fructus aurantii immaturus, coix seeds, cortex magnoliae officinalis, red peony roots, and Pseudostellaria heterophylla. Herbal medicines that functions in clearing heat, detoxification, and promoting diuresis include herba artemisiae scopariae, O. diffusa, phillyrin, radix scutellariae, plantain, coptidis rhizome, rhubarb, Polygonum cuspidatum, Gardenia jasminoides, christina loosestrife herb, dandelion, and dahurian patrinia herb. Herbal medicines that promote blood circulation to remove blood stasis include S. miltiorrhiza, Curcuma, red peony roots, rhubarb, and Angelica sinensis. Poria cocos, A. macrocephala Koidz, radix glycyrrhizae, coix seeds, P. heterophylla, Astragalus, Chinese yam, dried rehmannia roots, and wolfberries tonify the spleen and kidney. Poria cocos, P. ternata, pericarpium citri reticulatae, and complete snake gourd fruits reduce phlegm. These herbal medicines have functions of strengthening healthy qi, detoxification, removing blood stasis, and reducing phlegm. Statistics show that common prescriptions for treating chronic hepatitis B include xiao chaihu decoction (minor bupleurum decoction), sini powder (liver and spleen regulation powder), chaihu shugan powder (bupleurum liver soothing powder), wuling powder (diuretic powder), yinchenhao decoction (herba artemisiae scopariae decoction), yinchen-wuling powder (diuretic-herba artemisiae scopariae powder), yiguan decoction (liver soothing decoction), and sijunzi decoction (spleen strengthening decoction).
Software development
Software development is needed for the construction of the Clinical Data Center. The software system, acting as the core of the data center, comprises four layers, namely, module, platform, application, and presentation (Fig.2). The module layer defines two categories of functions of the data center. First, this layer encapsulates several basic functions of the data center. Each module is defined according to a certain operation or task of the data center and is designed with high reusability. Second, the module layer defines the platform-integrated management function, through which the basic function modules with low densities can be integrated according to the business requirements of the platform layer, providing reliable, functional, and high-quality service to the upper layer. The platform manages and utilizes data effectively by calling different function integration modules in the platform layer based on a series of application management software. The application layer defines the functional interfaces of the data center and the presentation layer. Through the software designed by the application layer according to different data requirements, users can visit the business interfaces provided by various platforms and have access to the functional service provided by the data center upon authorization of corresponding organizations. The presentation layer realizes the interaction between users through the B/S model.
O&M system
After the Clinical Data Center is operated upon completion of the infrastructure, the operating environment (e.g., infrastructure, database, and application system) of the data center should be maintained and managed.
The O&M management of the database is the priority of the data center. Storage, sharing, access, and modification of a large amount of data are realized by the database system, which is the core of the data center as an information aggregation. Therefore, managing and maintaining the database to ensure safety, integrity, and validity of data are crucial for the O&M of the database.
The O&M of the data center also includes the O&M of the application system, management of commercial application software and exploratory application software, software maintenance, patch management, and safety management.
A complete O&M management system can determine potential problems timely through 24/7 detection on the network, server, and database, as well as various software systems and hardware facilities. This system also reports problems to the O&M staff who can remove faults timely, thus avoiding heavy losses. During daily O&M, the O&M staff can also upgrade the maintenance plan and complement it according to the requirement change and functional extension of the data center or the change of external environment.
Real-world medical ethics
Modern medical ethics contains three basic principles: nonmaleficence, respect for patients, and justice. The principle of nonmaleficence requires medical staff with subjective motives or objective actions to help patients without harming them. The staff members are obliged to avoid harming patients, either intentionally or unintentionally. The principle of respect for patients means respecting the autonomy of patients (the right to decide what happens to their bodies). According to this principle, medical staff and researchers must obtain the informed consent of patients before performing any test or experiment. Before making the decision of accepting any test or experiment, the patient is entitled to be informed with the property, duration, purpose, approach and measures thereof, the possible inconvenience and harm, and the possible influence on his/her health and/or any other respect. The formal principle of justice means treating like cases alike and unlike cases unalike according to people’s demands, abilities, achievements, contributions to society, or potential contribution to the society. The principle of justice is crucial in terms of macroscopic and microcosmic distribution of medical resources.
Real-world medical ethics should not only follow the basic principles of modern medical ethics but also fully consider its uniqueness of keeping pace with medical treatment and connecting with subjects (patients) through data [
2]. Under the guidance of such principles and based on the Ethics Committee of HPHTCM (SIDCER certificate obtained), the medical staff of HPHTCM followed real-world medical ethics, such as developing the informed consent of the Research Hepatology Outpatient Clinic. The samples of patients agreeing to sign the informed consent were collected and stored in the biobank upon the approval of the ethics committee. The hospital also worked with the Health Management Center to create the Personal Health Record and to conduct follow-up visits for periodical outcome assessments.
Discussion
The Research Hepatology Outpatient Clinic was constructed under the theoretical guidance of the real-world TCM clinical research paradigm, which focuses on “conducting human-centered, data-oriented, and problem-driven scientific research by alternately adopting medical practice and scientific calculation to realize using the research results obtained from clinical practice” [
3]. Essentially, clinical research is the only approach to achieve the goal of “using the research results obtained from clinical practice.” Therefore, constructing a clinical research system is necessary to put the theory of real-world TCM clinical research paradigm into practice.
According to three functions, namely, clinical practice, clinical research, and health management of research clinics, the Research Hepatology Outpatient Clinic is divided into three centers, i.e., Clinical Research Center, Health Management Center, and Characteristics Diagnosis and Treatment Center, to realize the normal operation of the clinic, thus guaranteeing the sustainable development of clinical research. For the Research Hepatology Outpatient Clinic, the Clinical Research Center is the core, and the Characteristics Diagnosis and Treatment Center and Health Management Center are essential parts that play a supportive role. The three centers, which cover the entire content of the Research Hepatology Outpatient Clinic, provide expression to the principal characteristics of the TCM clinical research paradigm.
The Information Sharing System is a technical platform for TCM clinical research constructed based on the concept of clinical practice-cientific research integration and a series of standards and specifications using modern information technologies, as well as a selection of fully integrated approaches, such as computing, mathematical statistics, data mining, and artificial intelligence. HPHTCM built a shared system-based research outpatient clinic by following the concept of clinical practice-scientific research integration. During the process, the hospital built the Standard and Specification Center to standardize terminology, templates, and research content of the clinical research plan, as well as to develop a standard information management system. HPHTCM also built the Data Management Office, Data Collection Office, Data Mining Office, and System O&M Office and established the Hubei Traditional Chinese Medicine Clinical Data Center according to the requirements of the TCM Clinical Service Ability Building to Prevent and Treat Major Complicated Diseases Program launched by the SATCM in 2013 during the construction of branch data centers. A clinical research system was developed through the above work and further integration of the outcome assessment and medical ethics.
A data center, which combines the data of several decentralized units, realizes highly centralized data storage and management. A medical data center is a proper subset of a data center built in a comparatively centralized environment. Covering a large number of disciplines, the medical data center acts as a data information sharing platform that serves key regional clinical medical institutions, competent health and medical administrations, and the public with the core function of storing and processing the clinical diagnosis and treatment information of patients. Regional medical data centers are built to serve patients by using advanced computer and network technologies. Regional medical data centers are built into practical and convenient medical information sharing platforms with rational structures, network intercommunication, complete functions, and advanced technologies and play the roles of information exchange, information management, and information service; these data centers meet not only the requirements of regional medical institutions on clinical practice, scientific research, instruction, and management but also the demands of all levels of the society [
4].
Clinical outcomes are the clinical measuring results of healthy or unhealthy people obtained during a certain period of time, which can be expressed by a series of indexes. Outcome assessment is conducted to determine the layer and quantity of improved outcomes. As a popular research topic locally and internationally, the outcome assessment must be conducted from the perspective of patients using new concepts and proper assessment tools. During the assessment, patient-centered outcomes are assessed as a special part of the entire outcome. The clinical outcome assessment is of great practical significance [
5]. First, this method assesses clinical efficacy, such as fatality, recovery, remission, recurrence, side effects, and survival rates. Second, this method compares different therapies used to treat the same disease to determine the safest and optimal therapy. Third, this method compares the input-output ratios of different therapies used to treat the same disease to determine the most economical therapy, thus reducing the economic burden of patients. Fourth, this method investigates the satisfaction of patients to improve medical service level. Fifth, this method provides scientific basis for decision making regarding disease prevention and treatment, for example, psychological factors will affect not only the development and prognosis of hepatitis B but also the therapeutic effect of drugs [
5]. Lastly, this method assesses the quality of life of patients. The “shared system,” which is the core of TCM clinical research, forms the real-world TCM clinical research system together with the standard and specification system, Clinical Data Center, Outcome Assessment Center, and ethics committee of clinical medicine. The real-world TCM clinical research system is constructed to better conduct TCM clinical research, such as case control study, cohort study, therapy regularity study, and study on the inheritance of the valuable experience of TCM doctors. The real-world TCM clinical research system, which provides a large data platform, effectively probes into the law of development of the TCM industry and the development of medicine, particularly TCM in the future.
In 2011, 10 ministries and departments, including the Ministry of Science and Technology and the Ministry of Health, jointly developed the 12th Five-Year Plan for the Development of Medical Technology. This five-year plan put forward five medical technology development principles of “independent innovation, emphasizing on disease prevention, shifting focus to basic unit and community medical institutions, strengthening the commercialization of research findings, and system integration” and raised requirements of realizing health promotion in medical development, collaborative research in organization model, service integration in medical service provision, and independent innovation in industrial development through transformation. The above principles require hospitals to realize transformation into research hospitals. However, the approach of building research hospitals and the mode of research hospitals are practical problems met by these hospitals. During the process of building the Base, HPHTCM built the Research Hepatology Outpatient Clinic through exploration and improved the clinical research system in particular. This system could provide an effective mode for the construction of research hospitals.
Higher Education Press and Springer-Verlag Berlin Heidelberg
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