Evidence-based medicine and internationalization and standardization of subhealth 2012-12-18 Source:Subhealth Services 1 Weimin Liu1 , Baoyan Liu2 , Liyun He1 , Tao Sun3 , Mengzhi Sheng4 , Baobin Huang5 , Youping Li6 , Wenjing Bai1 Zhaoyin Lou, Department of Acupuncture, Moxibustion and Tuina, Outpatient Department, Zhejiang Traditional Chinese Medicine Society Jing Kang1 , Wenchao Mao1 (1 Institute of Clinical Basic Medicine of Traditional Chinese Medicine, Chinese Academy of Traditional Chinese Medicine, Beijing 100700 ) (2Chinese Academy of Traditional Chinese Medicine Beijing 100700) (3World Federation of Chinese Medicine Societies Subhealth Branch Beijing ) (4Ludao Singapore Pte Ltd, Singapore 639197) (5World Health Organization Representative Office Beijing 100600) (6China Center for Evidence-Based Medicine Chengdu 610041) [Abstract] This paper proposes that the evidence based on the objective evaluation of evidence-based medicine, using This paper proposes that, based on the evidence objectively evaluated by evidence-based medicine, international and domestic standards should be set to fully realize the internationalization and standardization of research on TCM interventions for subhealth, and under the guidance of evidence-based medicine and translational medicine, the efficacy of various interventions for subhealth should be objectively evaluated, and policy research should be strengthened to advocate evidence-based health decision-making and evidence-informed decision-making to promote the transformation from evidence to policy. 【Key words】Evidence-based medicine; Subhealth Evidence Based Medicine and Internationalization , Standardization of Subhealth LIU Weimin1, LIU Baoyan2, HE Liyun1, SUN Tao3, SHENG Mongchih4,HUANG Baobin5, LI Youping6, BAI Wenjing11, MAO Wenchao1, KANG Jing (1 Institute Of Basic Research In Clinical Medicine, China Academy Of Chinese Medical Sciences, Beijing 100700, China) (2 China Academy Of Chinese Medical Sciences, Beijing 100700, China) (3 Subhealth Branch, Chinese Association Of Chinese Medicine ,Beijing , China) (4 ROTOL SINGAPORE LTD, SINGAPORE 639197) (5 World Health Organization In China, Beijing 100600) (6 Chinese Evidence based Medicine Center, Beijing 100600) Chinese Evidence based Medicine Center, Chengdu 610041) 【Abstract】 According to Evidence based medicine, we proposed three ideas as below : 1.Adopt We propose three ideas as follows: 1. Adopt international method to form standard , thus to fulfil the internationalization ,standardization of Subhealth ;2. The effectiveness of Evidence Based Healthcare and Evidence Informed Health Policymaking, fulfil the transformation from evidence to policy. Keywords】Evidence Based Medicine; Subhealth At present, subhealth research has made great progress, during the 11th Five-Year Plan period, the progress of subhealth in China mainly includes: the proposal and improvement of the theory of type; the construction and improvement of the subhealth evaluation index system; the formation of the fatigue subhealth determination, intervention and efficacy evaluation scheme The formation of the fatigue self-assessment scale and its testing system; the development of the effect of TCM health education, evaluation index system and methodological research on psychological subhealth; the development of the new formulas Sleep No. 1 (nourishing Yin and calming the mind) and Sleep No. 2 (tonifying the spleen and calming the mind); the formation of the definition of subhealth insomnia; the formation of the TCM comprehensive intervention program for subhealth insomnia; the formation of the TCM health care tui-na treatment routine for somatic pain subhealth The formation of TCM health education effect questionnaire and basic database of subhealth; the study of body identification and diet for subhealth fatigue; the establishment of several centers and demonstration bases for treating the disease. Academician Zhong Nanshan pointed out that the development of traditional medicine should find the right breakthrough, and the most important breakthrough is to turn empirical medicine into evidence-based medicine. Only in this way can the efficacy of traditional medicine be scientifically evaluated, so that it meets the standards and the research on the mechanism of action of drugs will be based. Evidence-based medicine means “evidence-based medicine”, which is defined by Professor David Sackett, a renowned clinical epidemiologist, as “the careful, accurate, and judicious application of the best available research to determine patient care”. Evidence-based medicine uses large-scale, randomized, controlled studies and high-quality observational studies to evaluate the effectiveness and safety of treatment options and their impact on patients’ long-term prognosis. It focuses on meta-analysis and evidence quality assessment based on evidence from randomized controlled trials (RCTs) with the highest strength of evidence and high quality observational studies. Under the guidance of the concept of evidence-based medicine, the author proposes some ideas for the internationalization and standardization of TCM subhealth. The World Health Organization (WHO) attaches great importance to traditional medicine and has been formulating and releasing strategies, policies and standards to promote the development of traditional medicine, including Chinese medicine, worldwide. With the change of human health concept and medical model, the advantages and characteristics of TCM in preventing and treating modern diseases are being recognized and accepted by more and more countries and regions. In the WHO —- China Country Cooperation Strategy (2008-2013), it is stated that WHO will strengthen cooperation with the State Administration of Traditional Chinese Medicine, professional and academic groups and other partners to support the research, evaluation and subhealth service work specification – Music Conditioning, Subhealth Service Work Specification -Scraping and Conditioning‖, etc. Currently, the World Health Organization project chaired by Sun Tao, President of the World Federation of Chinese Medicine Societies Subhealth Professional Committee, introduces the theory of phenotype, adopts the internationally accepted method of developing standards, develops applicable standards and evaluation methods for TCM interventions in subhealth populations, proceeds to establish standards and evaluate clinical trials related to TCM interventions in subhealth, and provides technical guidance on international standards and methods. It will promote the development of relevant national policies, standards, norms and guidelines to ensure the effectiveness and quality of TCM products and TCM practice. It will support safer and regulated use of TCM and further integration of TCM into national health systems. The WHO will also provide technical support to relevant government departments to establish a global network mechanism for research collaboration and exchange between China and the rest of the world. The Chinese government also attaches great importance to the standardization of TCM. On July 13, 2006, the State Administration of Traditional Chinese Medicine issued the “Development Plan for the Standardization of TCM (2006-2010)”, stating that “standardization of TCM is an important technical support for the development of TCM, which is essential for promoting the academic development of TCM and It is of great importance to promote the academic development of TCM, improve the clinical efficacy of TCM, standardize the management of the industry, promote the administration according to law, promote the modernization of TCM, and accelerate TCM to the world”. TCM standardization is the process of formulating, issuing and implementing common and reusable TCM provisions for real or potential TCM problems in order to obtain the best order within a certain scope in the field of TCM, and its functions are to: promote TCM theoretical innovation and promote TCM academic development; promote TCM clinical level improvement and ensure TCM clinical efficacy; standardize TCM management and make TCM management It promotes the wide dissemination of TCM and enhances the international competitiveness of TCM; it promotes the innovation of TCM methods and means and the modernization of TCM; it improves the applicability of TCM products, processes or services, prevents TCM trade barriers and promotes TCM technical cooperation. The following standards have been published by the World Federation of Chinese Medicine Societies (WFCMS): “WFCMS Standard Formulation and Publication Practice”, “World Standard for Undergraduate (Pre-CMD) Education in Chinese Medicine”, “International Standard for Basic Terminology of Chinese Medicine in Chinese and English”, “International Standard for Basic Terminology of Chinese Medicine in Chinese and Western”, “International Standard for Basic Terminology of Chinese Medicine in Chinese and Portuguese”, “World Standard for Chinese Medicine (including Acupuncture) The International Standard for Chinese Medicine Practitioners’ Technical Titles”, “International Standard for Chinese Medicine Practitioners’ Technical Titles”, and “International Standard for Chinese Medicine Practitioners’ Basic Terminology in Chinese and French”. Standards and norms under development include Minimum Basic Requirements for International Education in TCM, Standards for International Organization of TCM Physicians, International Industry Standards for the Establishment of TCM Education Institutions, and International Industry Standards for TCM Practitioners. The specifications formulated by the State Administration of Traditional Chinese Medicine are: Technical Specification for TCM Health Care-Paste Recipe, Technical Specification for TCM Health Care-Medicinal Liquor, Technical Specification for TCM Health Care-Acupressure, Technical Specification for TCM Health Care-Acupuncture Technique, and TCM Health Care Technical Specification-Moxibustion”, “TCM Health Care Technical Specification-Children’s Tuina”, “TCM Health Care Technical Specification-Spinal Tuina”, “TCM Health Care Technical Specification-Whole Body Tuina”, etc.; “TCM Service Specification for Subhealth Management”, “TCM Service Specification for Subhealth Community Work Specification for Subhealth Management Chinese Medicine Service, Work Specification for Subhealth Community Service, Work Specification for Subhealth Service – Aromatic Conditioning, Work Specification for Subhealth Service – Meridian Conditioning, Work Specification for Subhealth Service – Juvenile Tui Na Conditioning, Work Specification for Subhealth Service -Fuyang Conditioning‖, and -System, and make objective assessment of intervention results accordingly. We have the following ideas on how to realize the road of internationalization and standardization of subhealth: Develop a global-oriented standardization strategy for Chinese medicine, cooperate closely with international standardization organizations such as ISO and WHO, absorb the experience of international standardization organizations in developing standards, absorb the latest advances in evidence-based medicine, introduce the Recommended Grades of Assessment, Development and Evaluation (GRADE), system evaluation, expert consensus Questionnaire survey, institutional field research, sample survey and other methods, under the guidance of WHO Guideline for guideline and ISO standard-setting guidelines, carry out research on international standard-setting methodology, develop procedural standard-setting guidelines, innovate at source in methodology, and guide the preparation, project establishment, drafting, consultation, review, approval, publication, review, promulgation, and implementation of standards. publication, review, promulgation, implementation, and revision process, determine the structure of standards and core content writing methods, construct technical committees, expert advisory committees, liaison groups, working groups, compilation committees, etc. for the development of standards for diseases in which TCM has outstanding advantages, and under the guidance of the successful experience of developing WHO clinical practice guidelines for 27 diseases in the Western Pacific Region and WHO subhealth standards Accelerate the development of a global-oriented TCM standardization strategy, seize the right to speak in TCM international standards, focus on the promotion and application of TCM standards in the international arena, seek to upgrade a number of domestic TCM standards, guidelines and norms to international TCM standards, improve international standards, regional standards, national standards, industry standards, local standards, and enterprise standards, and accelerate the development of guidelines, nomenclature, treatment standards, norms It also aims to improve international standards, regional standards, national standards, industry standards, local standards and enterprise standards, accelerate the development of guidelines, terminology, treatment standards, norms, pharmacopoeias, expert consensus, disease classification and other standards, as well as standards for the four diagnoses of TCM, production of TCM, TCM education, TCM management, TCM editing, translation of TCM terms, TCM animal experiments, TCM diagnosis and treatment equipment, TCM clinical departments, etc., lead the development direction of TCM industry at home and abroad, establish a technical regulation system in line with international rules, and promote the standardization, internationalization and modernization of TCM. The Chinese medicine industry is leading the development of Chinese medicine industry at home and abroad, establishing a technical and regulatory system in line with international rules, and promoting the standardization, internationalization and modernization of Chinese medicine. Under the inspiration of the World Health Organization, the World Federation of Chinese Medicine Societies and the International Organization for Standardization on the standardization of modern medicine and its inspiration on the standardization of Chinese medicine in China, and learning from the experience of standardization of Chinese medicine in Japan, Korea, Vietnam, Singapore and the United Kingdom, we put forward the idea of establishing a Chinese medicine science and technology industrial park in China, developing standardization centers and data centers, and promoting the standardization and informationization of Chinese medicine. At the same time, we are oriented to market economy, closely cooperate with domestic and foreign investment institutions, consortia and industries, get familiar with the operation of capital, introduce investors and internationalized managers with rich management experience, and carry out extensive economic cooperation. Seek support from management departments and domestic and foreign financial circles, pharmaceutical groups and the press, and vigorously promote the construction of a Chinese medicine industrial park of a certain scale. Facing the society and targeting the immediate interests of the people’s concerns, facilitate the integration of medical treatment, scientific research, data center, clinical evaluation, new drug creation and post-marketing evaluation, TCM health center, medical examination center, health care center, pharmaceutical factory, beauty salon, cosmetics, health food development, psychological counseling, medical equipment development and promotion, medicinal material cultivation and protective development, TCM education and training, real estate, tourism and leisure, etc. Construction to promote the prosperity of Chinese medicine. Strengthen cooperation with domestic and foreign management agencies, domestic and foreign universities, hospitals and research institutions, and close multidisciplinary cooperation. Emphasize innovation in methodological sources, take measures to invite in and go out, and use a common language acceptable to both domestic and foreign TCM and Western medical communities to conduct cross-cultural and cross-professional exchanges and innovations. Expand its influence in the international arena. Familiarize ourselves with the procedures related to the creation of new drugs by FDA and the procedures related to the declaration of health care products, and facilitate the passage of Chinese medicine fist products through foreign clinical trials of new drugs and approval of health care products to fully occupy the international market. The World Health Organization has proposed that for the formulation of guidelines, the method of holding expert consensus meetings can be used, inviting well-known domestic and foreign methodologists, clinicians, researchers, and health administrators to reach an expert consensus based on evidence-based medicine through the meetings. The specific process is as follows: Experts first declare in writing whether there is a conflict of interest. The experts evaluate the importance of the outcome indicators. The quality of the evidence is evaluated with reference to the GRADE evaluation form. The evidence summary form, study design, study quality, consistency, directness, sparse data, strong correlation, and publication bias were completed. Observe for any side effects that lead to discontinuation. Any poisoning deaths, etc. Fill in the balance situation table. Observe the severity of suboptimal health, intervention side effects, and the presence of toxic deaths, etc. The following relevant indicators were selected for the effect size: number needed to treat (NNT), confidence interval (CI), relative risk reduction rate (RRR), and weighted mean difference (WMD). The results of literature research, systematic evaluation, interviews, questionnaires, and consultation were combined to form recommendations of different intensities through expert consensus meetings. The experts commented on the reported results and made recommendations for revision. The revised draft guidelines are forwarded to the technical committee for voting. If more than two-thirds of the technical committee members are in favor, the draft guidelines are approved. The specific forms and steps are described in the relevant WHO and ISO documents. 2 Under the guidance of evidence-based medicine and translational medicine, the efficacy of various interventions on subhealth is objectively evaluated with the efficacy evaluation as the center Evidence-based medicine believes that clinical studies on TCM and its evidence are the basis for developing various relevant standards and promoting their application in the world. Research designs based on evidence-based medicine and clinical epidemiology and translational medicine can be recognized by different countries. Currently, research in subhealth is flourishing in China. How to learn from the experience in the design and implementation of excellent clinical trials, so that the objective efficacy of various TCM interventions for subhealth, such as gua sha, cupping, moxibustion, acupuncture, foot massage, chiropractic, full-body massage, compresses, herbal baths, poultices, herbal teas, herbal liquors, and proprietary Chinese medicines, can be internationally recognized and the research on subhealth can be promoted to internationalization is a topic worthy of our in-depth study. In 2003, the Chinese Academy of Traditional Chinese Medicine conducted a study on the basic symptoms of TCM for the high-risk group of sub-healthy people in Beijing, and established a domain system and measurement questionnaire of sub-healthy with high reliability and validity, based on the factors of “discomfort” and “diminished capacity” as well as “social and natural environment” and “endowment”, and formed the “Individual Health Status” measurement through the survey and analysis of more than 3000 people who excluded disease diagnosis. The mathematical model for measuring the health status of individuals was developed. We also discussed the basic identification method of subhealth by combining human and machine. In the study of subhealth, we proposed the clinical characteristics of individualized, dynamic and complex interventions in TCM, and combined with the latest advances in evidence-based medicine and clinical epidemiology to carry out the study design. Different study objectives correspond to different types of protocol design. The development of trial protocols should consider several aspects, such as trial design methods, population, randomization, blinding, outcome evaluation, safety monitoring, data collection and management, sample size, statistical methods, ethical review, economic evaluation, study reporting, and patient recruitment. In addition to randomized controlled trials, various clinical research methods such as registration studies, pragmatic randomized controlled trials, real-world clinical studies, patient-reported outcomes, physician-reported outcomes, and case studies are also explored for study design to objectively illustrate the efficacy of TCM interventions in subhealth, address common problems in TCM subhealth clinical research, conduct international multicenter studies, and explore the internationalization of TCM. The study will be conducted to explore the internationalization of TCM. 3 Strengthen policy research, advocate evidence-based health decision-making and evidence-informed decision-making, and promote the transformation from evidence to policy Clinical research on TCM and its evidence based on evidence-based medicine and clinical epidemiology is the basis for formulating policies and promoting their application in the world. In our long-term clinical practice, we have placed emphasis on clinical trial design using evidence-based medicine and clinical epidemiology to provide high-quality evidence to support the development of national policies. The development of a national strategic plan was organized. We also popularized the knowledge of evidence-based medicine and clinical epidemiology among health administrators, which laid the foundation for evidence-based health decision-making and evidence-informed decision-making. We call on relevant parties to formulate a national strategy for the development of the subhealth industry and corresponding methods to support the development of the industry, regulate the development of the subhealth industry and scientific research and development in China, promote the process of standardization and internationalization, strengthen cooperation with foundations and international consortia, raise multiple sources of funding, vigorously support the use of TCM in the private sector, expand the scale of clinics of famous veteran TCM practitioners, popularize TCM education, establish TCM health care at an early age, and promote the development of national physical fitness. We will promote the improvement of national physical fitness, improve the health condition of the nation, and ensure the realization of the goal of “health care for all” in the 21st century as proposed by the World Health Organization.