Experience inheritance from famous specialists based on real-world clinical research paradigm of traditional Chinese medicine

Abstract

The current modes of experience inheritance from famous specialists in traditional Chinese medicine (TCM) include master and disciple, literature review, clinical-epidemiology-based clinical research observation, and analysis and data mining via computer and database technologies. Each mode has its advantages and disadvantages. However, a scientific and instructive experience inheritance mode has not been developed. The advent of the big data era as well as the formation and practice accumulation of the TCM clinical research paradigm in the real world have provided new perspectives, techniques, and methods for inheriting experience from famous TCM specialists. Through continuous exploration and practice, the research group proposes the innovation research mode based on the real-world TCM clinical research paradigm, which involves the inheritance and innovation of the existing modes. This mode is formulated in line with its own development regularity of TCM and is expected to become the main mode of experience inheritance in the clinical field.

Keywords

traditional Chinese medicine (TCM) / real world / clinical research paradigm / famous specialist / experience inheritance

Introduction

Academic leaders are considered famous specialists in traditional Chinese medicine (TCM). Their academic ideas and valuable experiences, which have developed from their long-term clinical practice, represent the highest level of contemporary clinical medicine. Inheriting the academic ideas and experiences of these specialists improves the current level of clinical medicine, develops the TCM system, and plays an important role in the growth of budding physicians. The research group has formed a real-world innovation paradigm of clinical research after 10 years of continuous exploration, practice, and accumulation of data [1]. Using this paradigm, the research group reviews the extant research on the inheritance of experience from famous TCM specialists.

Overview of experience inheritance research

The main modes of experience inheritance include master and disciple, literature review, clinical-epidemiology-based clinical research observation, and analysis and data mining via computer and database technologies [2]. The inherited experience from famous TCM specialists mainly includes the academic ideas, diagnoses, treatments, prescriptions, and notions on medicine compatibility [3]. Each mode has its strengths and weaknesses. However, a scientific and instructive experience inheritance mode has yet to be developed.

Master and disciple mode

The master and disciple mode is the most traditional clinical experience inheritance mode that emphasizes the exchange and cooperation between the master and the successor. The successor is influenced by and gradually develops his/her comprehension of TCM through the words and deeds of the master (or the famous specialist). In line with clinical practice, this flexible, fresh, and personalized experience inheritance mode fully reflects the characteristics of individualized diagnosis, syndrome differentiation, and treatments in TCM. This mode maintains the characteristics of TCM and helps aspiring clinicians inherit TCM knowledge [4]. This mode is implemented through the interactions between the famous specialists and their disciples, graduate education, talent development, training projects, and post-doctoral heritage of TCM [5]. This mode may be implemented one-to-one or even at the national level. The State Administration of TCM has used the master and disciple mode by gathering five batches of famous TCM specialists to guide many aspiring TCM talents. This event demonstrates how the state recognizes and values the master and disciple mode.

However, the master and disciple mode has several limitations, such as the limited implementation between one specialist and one follower, small audience, slow training and growth of aspiring TCM talents, personal capacity of the successor that limits the amount of knowledge that can be inherited, poor research quality, perception toward learning with the teacher, duration of staying with the teacher, and cooperation and understanding between masters and disciples. Therefore, this technique can only impart a few ideas and experiences from famous TCM specialists to their disciples [6], especially in the current TCM context where the number of famous TCM specialists is very few. Therefore, the master and disciple mode cannot meet the actual needs of TCM learners.

Summarizing the experiences of specialists through literature review

TCM has been developed for thousands of years, with each passing age producing a significant number of clinical cases that contain academic ideas and clinical experiences of famous TCM specialists. Modern doctors refer to some of these clinical cases, such as “Wu Ju Tong Medical Records” and “Pu Fuzhou Medical Records,” as well as to different compilations of medical cases, such as “Classified Medical Records of Famous Physicians” and “Essence of the Medical Records of Qing Dynasty Doctors,” and “Selected Modern Medical Cases.” The experiences and clinical cases of TCM specialists have also been recorded in all kinds of journals and newspapers. The literature review mode involves the collection and analysis of a comprehensive set of literature from TCM specialists. A database of Chinese medicine literature that summarizes the experiences of famous TCM specialists can be created by compiling traditional philology and by using database technology [7].

The literature review mode requires a large collection of specialist materials. The collection of literature is not only a heavy workload, but also a difficult task to achieve. A relatively small amount of information may be obtained from the summarized comments, thoughts, and publications of specialists. Moreover, a system for the general information and organic association of long-term clinical experience has yet to be developed, and some periods have missing research data, records, and comparative studies of famous TCM specialists [6].

Verifying the experiences of specialists by clinical research observation

Clinical epidemiology has introduced modern epidemiology, statistics, and other relevant theories, and has innovated the rigorous clinical research design, measurement, and evaluation of the clinical research methodology [8]. Clinical research requires a careful design, an accurate measurement, and a reasonable assessment. The current clinical research designs include prospective study, retrospective study, and descriptive study. Randomized controlled trial (RCT) is recognized as the best clinical research laboratory method as well as the standard of efficacy evaluation. Chinese medicine researchers conduct a large number of clinical studies by using clinical epidemiology methods [9]. The first Chinese medicine RCT was reported in 1983 [10], which was followed by an increasing number of RCTs in the subsequent years. Researchers on experience inheritance generally select cases that involve therapies and prescriptions with favorable clinical efficacy when conducting their clinical validation studies.

Unlike real-world studies, RCT is conducted under ideal conditions. A large-scale clinical RCT is long, expensive, time-consuming, and difficult to perform. RCT has strict inclusion and exclusion criteria that limit the selection of cases and the representativeness of the results. Therefore, the results of RCT studies cannot represent the entire picture of a particular disease and cannot reveal the general laws of such disease. Given that RCT studies on the experience of TCM specialists mostly focus on a certain diagnosis and treatment of a single experience of the disease, the findings cannot reflect the academic thinking of TCM specialists [11].

Analyzing and presenting the experiences of TCM specialists using modern science and technology

The development of modern science and technology, especially database technology, network technology, and statistical techniques, provides new methods for investigating the experiences of TCM specialists. The combination of data mining and computer technology allows clinical complex data analysis and rule discovery, which provides important technical support. The first traditional Chinese medicine expert system was established in early 1979, which was followed by the development of 220 expert systems in the subsequent years. The performance of these systems tends to fluctuate, from which they gradually recover [12]. Studies on the clinical experience of TCM specialists have gradually changed their focus from a rule-based expert system to establish an effective mathematical model for simulating the thinking process of Chinese specialists [13]. The rapid development of artificial intelligence, information, and database technologies has introduced new ways for clinical information collection, assisted diagnosis, analysis and data mining, and clinical decision support, which provide experience inheritance studies with a wider research scope.

With the aid of modern science and technology, the analysis and presentation of TCM specialist experience is currently based on previous literature or a clinical trial design. Recent studies on the experience of TCM specialists suffer from a small sample size, lack of necessary knowledge base support, standardized terms, and experts in TCM, computers, and mathematics. The current methods and the mathematical model have not produced any breakthroughs. Therefore, the results of these studies may not be recognized within the clinical industry.

Clinical research is increasingly being valued in the real world because of the changes in the disease spectrum, formation of the aging society, changes in the medical purposes and the medical model, and emergence of comparative studies. The rapid development of digital information technology and the arrival of the big data era have turned data into important factors of production. The advanced characteristics of individualized diagnoses and treatments as well as of the whole TCM regulation can only be fully implemented under real-world conditions. Studies on experience inheritance must take full advantage of the “thinking, technology, and data” of the big data era [14], innovate the TCM clinical research model, and form the TCM clinical research paradigm based on its own development law.

Formation and practice of the TCM clinical research paradigm in the real world

Formation of the TCM clinical research paradigm

The research group has been trying to develop a new TCM clinical research paradigm for more than a decade under the leadership of Professor Liu Baoyan. In 2002, the research group proposed to build a digital TCM [15] and to establish a system for the modern individual diagnosis and treatment of TCM and for the integration concept of clinical research based on their first proposal [16]. As a guide, clinical research was successfully implemented as the core of syndrome differentiation and treatment during the SARS outbreak in 2003 [17]. This event was followed by the design and development of “the clinical research information sharing system of TCM” [18-20], which was used in the individual diagnosis and treatment of cancer, stroke, diabetes, coronary heart disease, and other major diseases. Hundreds of TCM specialist-experience inheritance studies were also performed, which were difficult to conduct in a conventional manner. An innovative TCM clinical research paradigm, which accords with the TCM development law based on the real-world integration of clinical research, is formed through the unremitting accumulation of clinical research and the gradual formation of a clinical research community [1].

The real-world TCM clinical research paradigm is a product of the time when people begin to show concern toward the systemic complexity of science, digital information technology rapidly develops, and the big data era begins to emerge. This paradigm is expected to bring changes in TCM clinical research and become the only way to investigate TCM experience inheritance and innovation.

Practice of the TCM clinical research paradigm

“The clinical research information sharing system of TCM” is designed and developed for clinical research design in the real world. This system aims to establish the tools for clinical practice digitization and datamation as well as the platform of complex mass for clinical data management and utilization. This system serves as real-world technical support of the TCM clinical research paradigm and as a powerful tool to change TCM clinical research using big data. This system includes the general structure (the digital clinical term application system), three platforms (medical service, data management, and clinical research), and four functional modules (data acquisition, quality control, data integration, and data analysis) [21-24]. This information sharing system is currently being used in the departments of more than 150 hospitals, has performed more than 400 clinical studies, has accumulated large numbers of clinical cases from more than 50 famous TCM specialists, and has gathered more than 300 000 clinical records that cover coronary heart disease, diabetes, stroke, cancer, and other medical diseases. This system has also been used as the basis for more than 20 national TCM clinical research works, which makes this system one of the key technology platforms of TCM clinical research.

Innovation mode of experience inheritance from famous TCM specialists

Research foundation

Under the leadership of Professor Baoyan Liu and Professor Yinghui Wang, the research group explored the new model of experience inheritance from famous TCM specialists by using the clinical research integration concept and the real-world TCM clinical research paradigm as guides. Methodologically, the research group explored the experience inheritance pattern of famous TCM specialists [6] and used man-machine and people-oriented tools to develop several methods for investigating the experiences of famous specialists [25]. Technically, the research group developed the clinical research data collection system for famous TCM specialists [26], developed the dynamic structured data entry standards for the electronic medical records of famous TCM specialists to gather the diagnosis and treatment data of these specialists in a structured and standardized manner [27], established a Chinese medicine clinical data warehouse for clinical research by using structured clinical data [28], and established a mining platform for the experiences of famous TCM specialists that analyzed the multi-dimensional relationship among clinical elements and the discovery of clinical experience by using information and data mining technologies [29,30]. Moreover, the compounding rules of Chinese herb prescriptions for treating liver and spleen disharmony symptoms were summarized by using a complex network analysis system [31]. The clinical core prescription of Professor Zhizheng Lu was determined by using typical clinical records and by taking advantage of the methods in the scale-free network model [32]. The clinical treatment experience and academic thought of Professor Conghuo Tian were summarized [33], and the general rules and individual differences in the clinical experiences of famous TCM specialists were investigated [34].

Pattern formation

A new experience inheritance mode (Fig. 1) is developed through several methods. First, the real-world TCM clinical research paradigm is used as a guide. Second, the clinical research and information integration concept is utilized as the dominant thought. Third, the clinical research and information sharing system technology platform is applied. Fourth, the clinical diagnosis and treatment information of famous TCM specialists are collected in a comprehensive, standardized, accurate, and timely manner. Fifth, the data are imported, integrated, preprocessed, processed, analyzed, and mined. Sixth, a man-machine combination and a man-oriented systematic analysis of the academic thought and clinical experience of famous TCM specialists is performed. Seventh, “experience” is transformed to “knowledge” and then to “evidence.” Finally, the clinical information of famous TCM specialists is collected, their clinical experiences are extracted, their clinical applications are authenticated, their mechanisms are investigated, and their clinical theories are validated.

Constitution of the main technical system

The main technical system includes a digitized clinical terminology application system. This system comprises clinical research programs that are designed based on real-world data, structured clinical data collection system, data conversion, storage, and management platform, data warehouse and mining analysis platform, data quality control system, and staff. These components cooperate with one another through a close organic connection to collect and to manage clinical data from famous TCM specialists and to integrate and to utilize high-quality clinical data.

Digitized clinical terminology application system

The standardized clinical terminology serves as the basis for the collection, analysis, and mining of clinical data. Based on standardized clinical terminologies, the sharing system has set up a TCM clinical terminology set and a clinical terminology dictionary that contains 400 000 and 200 000 words, respectively. A clinical terminology management platform is also developed for the management and maintenance of terms (Fig. 2). The famous TCM specialists generally have distinctive personal language features. Their clinical terms must also be improved to collect and use the structured clinical information collection from these specialists based on the TCM clinical terminology set and the clinical terminology dictionary.

Clinical research program design based on real world

The real-world clinical research program design is an important part of the sharing system and plays a key role in the generation of the expected results. The research design theme is determined before the implementation process design is developed based on the research objectives and on the scientific management mode and ethics of each hospital [35]. The details of the implementation process are then refined, the operation specifics are confirmed, and a person is appointed to ensure that the work is completed as planned. The real-world clinical research program design is different from the clinical research program design of clinical epidemiology. Rather than limiting the clinical thinking, clinical behavior, and patient selection options of doctors, this design aims to collect real clinical information, to form structured data around the research topic, and to facilitate the analysis and mining of data.

Structured clinical data acquisition system

The structured electronic medical record system is a technology tool for the comprehensive datamation of clinical diagnosis and treatment information. This tool supports a comprehensive, standardized, and real-time acquisition of multi-source, multi-media, and multi-format clinical information. Written medical records are converted into structured data storage. This tool can also integrate hospital information system integration (HIS), laboratory information system (LIS), picture archiving and communication system (PACS), and other systems (Fig. 3). The most basic and important functions of this tool include its comprehensive, standardized, accurate, and real-time collection of the diagnosis and treatment data of famous specialists, its maintenance of the multi-dimensional dynamic characteristics of such data, its comprehensive collection of the track record of specialists, its combination of structured data acquisition and unstructured text collection, and its synchronous acquisition of clinical medical business and scientific data.

Data conversion storage and management platform

The data conversion storage and management platform supports the dynamic configuration and integration of large-scale, multi-source, and heterogeneous clinical data to complete several tasks, such as data extract-transform-load system (ETL), use of comprehensive software tools, real-time and dynamic data cleaning, batch summary, data processing, and data conversion, according to the characteristics of the raw data. The data are automatically imported into the data warehouse (Fig. 4). The unified model and the clinical data warehouse are built according to the features of the famous specialist research and inheritance. The batch processing of large-scale data is supported by the standardization of clinical terms to achieve data processing, conversion, search query, and visualization display.

Analysis and data mining platform

To improve the multi-dimensional retrieval and analysis systems, the research group independently developed a complex network analysis software, which formed three types of effective mining analysis algorithms for the compatibility analysis of clinical prescription drugs, the “symptom-syndrome-herbs” relationship, and the optimization of clinical treatment programs [36]. Basic statistical analysis and data mining tools, such as SAS, SPSS, and WEKA, as well as statistical analysis methods, such as cluster analysis, contingency analysis, association rules, discriminant analysis, factor analysis, and the decision-making model, are used to investigate the academic thinking and experience of famous specialists through multi-dimensional dynamic analysis and a combination of qualitative and quantitative methods (Fig. 5).

Data quality control

Strengthening quality control ensures the collection of high-quality clinical data. Only high-quality data can meet the needs of clinical research. The quality control system comprises strict quality control regime and technology that is used throughout the clinical research, specifically in the whole data collection, dumping, and analysis processes. During the experience inheritance process, a perfect quality control system must be established and quality control measures must be implemented to ensure that the source of data is true, complies with the requirements of the research program design, and meets the needs of clinical research.

Staff team building

Inheriting the experience of a famous specialist is a long-term system engineering process that requires the establishment of a long-term operational mechanism, the preparation of a top-level design, and the organization, management, and building of a staff team. The research team must comprise a specialist, heirs or disciples, computer professional, standardized personnel, IT staff members, data mining staff members, and other multi-disciplinary staff members. The team must also establish appropriate institutional norms and safety management system standards.

Characteristics and disadvantages

The proposed experience inheritance mode is developed under the guidance of the real-world TCM clinical scientific research paradigm and aims to explore the experience and knowledge of famous TCM specialists based on their real clinical diagnosis and treatment practices. Data on such experiences and knowledge are collected upon the completion of the normal medical service of these specialists. This mode is also developed in accordance with its own law of TCM development. The establishment of this model is a systematic project that involves the construction of the core technologies (clinical terms application and structured electronic medical records systems, and data storage and management and data mining and analysis platforms), the building of a clinical research program and system designs, and the organization, management, and forming of a team.

However, this mode also has some disadvantages. The creation of the mode is a systematic project that requires coordination from the relevant departments and disciplines as well as a higher degree of hospital informationization. The proposed experience inheritance mode is more complex and difficult to implement as compared with other inheritance patterns. The technology platform of the mode is imperfect and has low maturity. While some modules are inconvenient and slow, these components must be optimized and improved further. The intelligence of this mode has not yet reached the ideal levels, and the low efficiency of clinical research must be further improved to satisfy the demands of clinical scientific research.

Conclusions

The mode of experience inheritance from famous TCM specialists is developed from real-world TCM clinical research paradigm that benefits from the “thinking, technology, and data” advantage of the data-oriented era. This paper proposes a new experience inheritance mode that uses clinical diagnosis and treatment data and continuously accumulates large amounts of clinical data and applications to analyze, verify, and improve the academic thought and experience of famous TCM specialists. In accordance with the “from the clinic, to the clinic” development law of TCM, the proposed mode is expected to become the main mode for clinical experience inheritance research.

Inheriting the experience of famous TCM specialists requires both transfer and heritage. Transfer is mainly summed to obtain the academic thought and experience of the specialist, which eventually leads to knowledge discovery. Heritage mainly refers to the need to verify the validity, security, and stability of the experience of the specialist as well as the need to evaluate the effect of inheriting the academic thought and experience of the specialist, such as how such experience can affect the young physician or heir or how the young physician and the specialist differ in terms of their clinical efficacy. These questions present interesting topics that need to be studied further.

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